Chronic illness and long-term care : breakthroughs in research and practice 9781522571230, 152257123X

Table of contents :
Title Page
Copyright Page
Editorial Advisory Board
List of Contributors
Table of Contents
Preface
Section 1: Alzheimer's Disease and Dementia
Chapter 1: The Impact of Decline on Everyday Life in Alzheimer's Disease
Chapter 2: Towards an HCI-Based Symbiotic Environment for Alzheimer's Support
Chapter 3: Assistive Technologies and the Carers of People With Dementia
Chapter 4: Visual Communication to Improve Relationship Quality in Spousal Caregivers of Individuals With Alzheimer's Disease
Chapter 5: Preventing Alzheimer's Wandering
Chapter 6: Integrated eCare in Dementia
Section 2: Autoimmune Diseases
Chapter 7: Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner
Chapter 8: HIV/AIDS Discrimination, Stigmatization, and Denial
Section 3: Blood Disorders
Chapter 9: An Artificial Intelligence Approach to Thrombophilia Risk
Section 4: Cardiovascular Disease
Chapter 10: Pharmacogenomics and Cardiovascular Disease
Chapter 11: Coronary Heart Disease Prognosis Using Machine-Learning Techniques on Patients With Type 2 Diabetes Mellitus
Chapter 12: Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions in an Aging Population
Section 5: Caregivers and Education
Chapter 13: Respite Tourism for Family Caregivers
Chapter 14: Turning PAGES With Health Coaching and Family Involvement
Chapter 15: Knowledge Management for Health Care and Long-Term Care in the Technology-Organization-Environment Context
Chapter 16: Case Studies of Chronically Ill Children
Section 6: Diabetes
Chapter 17: Analyzing Online Social Support Within the Type 1 Diabetes Community
Chapter 18: Diabetes Mellitus and Aging
Chapter 19: Health Guidance Provision Infrastructure for Personalized Diabetes Management
Section 7: Kidney Disease
Chapter 20: General Approach to Evaluating Beneficial and Adverse Effects of CAM Use in Kidney Diseases
Chapter 21: Coping and Transition in Young People With Chronic Kidney Disease (CKD) – Maintaining Best Practice
Section 8: Mental Illness
Chapter 22: Global Burden of Mental Disorders
Chapter 23: Psychosocial Intervention Strategies for Patients With Schizophrenia
Chapter 24: Management of Chronic Mental Illnesses and Substance Use Disorders
Chapter 25: Chronic Mental Illness in Old Age Homes
Chapter 26: Comorbidity of Medical and Psychiatric Disorders in Geriatric Population
Chapter 27: Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment in Child and Adolescent Population
Chapter 28: Chronic Mental Illness in Prisons
Section 9: Nerve Disorders and Pain Management
Chapter 29: Medical Management of Trigeminal Neuralgia
Chapter 30: V2 Rhizotomy
Chapter 31: Effecting Superior Pain Management Strategies by Combining Technology With Tradition
Chapter 32: Manage My Pain
Section 10: Remote Monitoring, Mobile Health, and Medical Imaging
Chapter 33: Chronic Condition Management Using Remote Monitoring and Telehomecare
Chapter 34: Towards a Telehomecare in Algeria
Chapter 35: Virtual Carer
Chapter 36: Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT
Chapter 37: Commercial Home Assistance Services
Chapter 38: STRIPA
Chapter 39: Performance of Service-Oriented Architecture (SOA)
Section 11: Spending and Economics
Chapter 40: The Economics of Long-Term Care
Chapter 41: Long-Term Care Spending Relevant to U.S. Medicaid Expansion
Index

Citation preview

Chronic Illness and LongTerm Care: Breakthroughs in Research and Practice Information Resources Management Association USA

Published in the United States of America by IGI Global Medical Information Science Reference (an imprint of IGI Global) 701 E. Chocolate Avenue Hershey PA, USA 17033 Tel: 717-533-8845 Fax: 717-533-8661 E-mail: [email protected] Web site: http://www.igi-global.com Copyright © 2019 by IGI Global. All rights reserved. No part of this publication may be reproduced, stored or distributed in any form or by any means, electronic or mechanical, including photocopying, without written permission from the publisher. Product or company names used in this set are for identification purposes only. Inclusion of the names of the products or companies does not indicate a claim of ownership by IGI Global of the trademark or registered trademark. Library of Congress Cataloging-in-Publication Data Names: Information Resources Management Association, editor. Title: Chronic illness and long-term care : breakthroughs in research and practice / Information Resources Management Association, editor. Description: Hershey PA : Medical Information Science Reference, [2019] | Includes bibliographical references. Identifiers: LCCN 2018017598| ISBN 9781522571223 (hardcover) | ISBN 9781522571230 (ebook) Subjects: | MESH: Chronic Disease | Long-Term Care Classification: LCC RT120.L64 | NLM WT 500 | DDC 362.16--dc23 LC record available at https://lccn.loc.gov/2018017598

British Cataloguing in Publication Data A Cataloguing in Publication record for this book is available from the British Library. The views expressed in this book are those of the authors, but not necessarily of the publisher. For electronic access to this publication, please contact: [email protected].

Editor-in-Chief Mehdi Khosrow-Pour, DBA Information Resources Management Association, USA

Associate Editors Steve Clarke, University of Hull, UK Murray E. Jennex, San Diego State University, USA Annie Becker, Florida Institute of Technology, USA Ari-Veikko Anttiroiko, University of Tampere, Finland

Editorial Advisory Board Sherif Kamel, American University in Cairo, Egypt In Lee, Western Illinois University, USA Jerzy Kisielnicki, Warsaw University, Poland Amar Gupta, Arizona University, USA Craig van Slyke, University of Central Florida, USA John Wang, Montclair State University, USA Vishanth Weerakkody, Brunel University, UK



List of Contributors

Aarnoutse, Floor / Utrecht University, The Netherlands................................................................... 764 Abreu, Carlos / Instituto Politécnico de Viana do Castelo, Portugal.................................................. 77 Ainslie, Kristy M. / The University of North Carolina at Chapel Hill, USA..................................... 112 Akbar, Shamsi / King George Medical University – Lucknow, India............................................... 509 Almeida, Isa Maria / APDP-ERC, Portugal...................................................................................... 198 Au Yeung, Tsoi Ming / Hong Kong Community College, Hong Kong............................................... 218 Azam, Muhammad Abid / York University, Canada & Toronto General Hospital, University Health Network, Canada............................................................................................................... 642 Bachelder, Eric M. / The University of North Carolina at Chapel Hill, USA.................................... 112 Bateman, David F. / Shippensburg University, USA.......................................................................... 303 Batenburg, Ronald / Utrecht University, The Netherlands............................................................... 764 Benbow, Susan Mary / University of Chester, UK............................................................................... 43 Bhattacharyya, Sarmishtha / University of Chester, UK................................................................... 43 Bird, Jennifer Lynne / Florida Atlantic University, USA.................................................................. 255 Bolch, Ellen B. / THA Group, USA..................................................................................................... 669 Brazeau, Daniel Alan / University of New England, USA................................................................. 184 Busson, Britt / Azusa Pacific University, USA....................................................................................... 1 C., Sushma / DIMHANS, India.......................................................................................................... 445 Caldeira, Filomena / Hospital do Espírito Santo de Évora, Portugal.............................................. 161 Campos, Lucas W. / Summit Pain Alliance, USA.............................................................................. 610 Chan, Enoch / University of New South Wales, Australia................................................................. 218 Chan, Gabriel Hoi Huen / Hong Kong Community College, Hong Kong......................................... 218 Chen, Naihan / The University of North Carolina at Chapel Hill, USA........................................... 112 Clarke, Hance / Toronto General Hospital, University Health Network, Canada............................ 642 Cline, Jenifer / Great Falls School District, USA.............................................................................. 303 Cunha, Jorge / Instituto Politécnico de Viana do Castelo, Portugal................................................... 77 De Decker, Bart / K.U.Leuven, Belgium............................................................................................ 737 Decroix, Koen / Katholieke Hogeschool Sint – Lieven, Belgium....................................................... 737 Delaney, Sarah / Work Research Centre, Ireland................................................................................ 90 Do, Huy M. / Stanford University, USA.............................................................................................. 610 Dornblaser, Emily K. / University of New England, USA.................................................................. 184 Dragoni, Aldo Franco / Università Politecnica delle Marche, Italy.................................................. 709 Dubey, Deepanshu / IIFM Bhopal, India.......................................................................................... 785 Dubey, Deepika / Uttarakhand Technical University, India.............................................................. 785 Ebberwein, Joseph F. / THA Group, USA.......................................................................................... 669  



Ferguson, Emily / Independent Researcher, USA.............................................................................. 303 Foo, CK / Honorary Health Informatics, Australia........................................................................... 631 Freeman, Nola / Magnolia Community Services, USA....................................................................... 59 Gamboa, Hugo / FCT-UNL, Portugal............................................................................................... 198 Garg, Amit / Institute of Human Behaviour and Allied Sciences (IHBAS), India............................. 486 Garg, Bhavuk / IHBAS, India............................................................................................................ 556 Gibbon, Thomas C. / Shippensburg University, USA........................................................................ 303 Giokas, Kostas / AiM Research Team, Biomedical Engineering Laboratory, National Technical University of Athens, Greece......................................................................................................... 378 Grañeda, José / Hospital do Espírito Santo de Évora, Portugal....................................................... 161 Gusmão, Rodrigo / Hospital do Espírito Santo de Évora, Portugal................................................. 161 Hadjileontiadis, Leontios J. / Aristotle University of Thessaloniki, Greece........................................ 14 Holda, Robert / Independent Respite Care Specialist, USA.............................................................. 242 Iliopoulou, Dimitra / AiM Research Team, Biomedical Engineering Laboratory, National Technical University of Athens, Greece......................................................................................... 378 Janmohamed, Tahir / ManagingLife, Canada................................................................................. 642 Katz, Joel / York University, Canada & Toronto General Hospital, University Health Network, Canada.......................................................................................................................................... 642 Kaushik, Pratima / Amity University Uttar Pradesh, India.............................................................. 528 Khanna, Amit / Institute of Human Behaviour and Allied Sciences (IHBAS), India................. 486,556 Khanna, Prerna / Pushpanjali Crosslay Hospital, India........................................................... 486,556 Khurana, Hitesh / Pt. B. D. Sharma PGIMS, India.......................................................................... 509 Kosgi, Srinivas / Dharwad Institute of Mental Health and Neurosciences, India............................. 468 Koutsouri, Georgia / AiM Research Team, Biomedical Engineering Laboratory, National Technical University of Athens, Greece......................................................................................... 378 Koutsouris, Dimitris / National Technical University of Athens, Greece......................................... 378 Kreepala, Chatchai / Srinakharinwirot University, Thailand........................................................... 397 Kyprioti, Aikaterini / Aristotle University of Thessaloniki, Greece................................................... 14 Latman, Vered Valeria / York University, Canada............................................................................ 642 Lo, Man Fung / The Hong Kong Polytechnic University, Hong Kong............................................... 277 Lopes, Manuel / Universidade de Évora, Portugal........................................................................... 720 Maki, Kristin G. / University at Buffalo (SUNY), USA...................................................................... 338 Mandiliotis, Dimitrios / Aristotle University of Thessaloniki, Greece................................................ 14 Martins, M. Rosário / Universidade de Évora, Portugal................................................................... 161 Matos, Pedro / APDP-ERC, Portugal................................................................................................ 198 Matthews, Kimberly / Independent Researcher, USA...................................................................... 303 McNeal, Ramona Sue / University of Northern Iowa, USA............................................................... 821 Mendes, David / DECSIS, Portugal................................................................................................... 720 Milutinovic, Milica / K.U.Leuven, Belgium....................................................................................... 737 Mishra, Preeti / SMI Medical College and Hospital, India.............................................................. 359 Muhammad, Shahid / The Renal Patient Support Group (RPSG), UK............................................ 425 Naessens, Vincent / Katholieke Hogeschool Sint – Lieven, Belgium................................................ 737 Neves, João / Drs. Nicolas & Asp, UAE............................................................................................. 161 Neves, José / Universidade do Minho, Portugal................................................................................. 161 Ng, Peggy Mei Lan / The Hong Kong Polytechnic University, Hong Kong....................................... 277 O’Mally, Aisha K. / University at Buffalo (SUNY), USA................................................................... 338



Paiva, Sara / Instituto Politécnico de Viana do Castelo, Portugal...................................................... 77 Pandey, Jyoti Mishra / Government Medical College Chandigarh, India......................................... 359 Park, Lovingly Quitania / Azusa Pacific University, USA..................................................................... 1 Peine, Kevin J. / The University of North Carolina at Chapel Hill, USA........................................... 112 Peleja, Rui / Instituto Politécnico de Viana do Castelo, Portugal....................................................... 77 Piette, Katherine F. / THA Group, USA............................................................................................. 669 Pimentel, Angela / FCT-UNL, Portugal............................................................................................ 198 Prasad, Barre Vijay / Dharwad Institute of Mental Health and Neurosciences, India..................... 468 Qian, Xiang / Stanford University, USA............................................................................................ 610 R., Ashwini / Dharwad Institute of Mental Health and Neurosciences, India.................................. 468 Raposo, João / APDP-ERC, Portugal................................................................................................ 198 Renes, Cassandra / Utrecht University, The Netherlands................................................................. 764 Ribeiro, Rogério T. / APDP-ERC, Portugal....................................................................................... 198 Rodrigues, Irene Pimenta / Universidade de Évora, Portugal.......................................................... 720 Romão, Artur / DECSIS, Portugal.................................................................................................... 720 Schmeida, Mary / Kent State University, USA.................................................................................. 821 Schwilk, Christopher L. / Shippensburg University, USA................................................................. 303 Seto, Sai Wang / Western Sydney University, Australia..................................................................... 218 Singh, Uday Pratap / Madhav Institute of Technology and Science, India........................................ 785 Singh, Yatendra Pal / Lucknow University, India.............................................................................. 141 Sinha, Pallavi / Institute of Human Behaviour and Allied Sciences (IHBAS), India......................... 486 Spruit, Marco / Utrecht University, The Netherlands....................................................................... 764 Stachura, Maximillian E. / Georgia Regents University, USA.......................................................... 669 Sweigart, Katie / Shippensburg University, USA.............................................................................. 303 Tangkiatkumjai, Mayuree / Srinakharinwirot University, Thailand............................................... 397 Tavaragi, Meghamala S. / DIMHANS, India.............................................................................. 445,568 Telischak, Nicholas / Stanford University, USA................................................................................ 610 Toumpas, Konstantinos / Aristotle University of Thessaloniki, Greece............................................. 14 Vicente, Henrique / Universidade de Évora, Portugal...................................................................... 161 Vilhena, João / Universidade de Évora, Portugal............................................................................. 161 Wanner, Eric T. / Palm Beach Sports Medicine & Orthopaedic Center, USA.................................. 255 Weinrib, Aliza / Toronto General Hospital, University Health Network, Canada............................ 642 Worby, Craig P. / University of New England, USA........................................................................... 184 Yuen, Peter P. / The Hong Kong Polytechnic University, Hong Kong................................................ 803 Zarour, Karim / University Constantine 2, Algeria.......................................................................... 687 Zhang, Niushen / Stanford University, USA...................................................................................... 591

Table of Contents

Preface.................................................................................................................................................. xiv

Volume I Section 1 Alzheimer’s Disease and Dementia Chapter 1 The Impact of Decline on Everyday Life in Alzheimer’s Disease........................................................... 1 Lovingly Quitania Park, Azusa Pacific University, USA Britt Busson, Azusa Pacific University, USA Chapter 2 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support........................................... 14 Leontios J. Hadjileontiadis, Aristotle University of Thessaloniki, Greece Dimitrios Mandiliotis, Aristotle University of Thessaloniki, Greece Konstantinos Toumpas, Aristotle University of Thessaloniki, Greece Aikaterini Kyprioti, Aristotle University of Thessaloniki, Greece Chapter 3 Assistive Technologies and the Carers of People With Dementia: Empowerment and Connection..... 43 Sarmishtha Bhattacharyya, University of Chester, UK Susan Mary Benbow, University of Chester, UK Chapter 4 Visual Communication to Improve Relationship Quality in Spousal Caregivers of Individuals With Alzheimer’s Disease...................................................................................................................... 59 Nola Freeman, Magnolia Community Services, USA Chapter 5 Preventing Alzheimer’s Wandering: The Potential of Involving Communities..................................... 77 Sara Paiva, Instituto Politécnico de Viana do Castelo, Portugal Rui Peleja, Instituto Politécnico de Viana do Castelo, Portugal Jorge Cunha, Instituto Politécnico de Viana do Castelo, Portugal Carlos Abreu, Instituto Politécnico de Viana do Castelo, Portugal 



Chapter 6 Integrated eCare in Dementia: The Irish Experience in the INDEPENDENT Project......................... 90 Sarah Delaney, Work Research Centre, Ireland Section 2 Autoimmune Diseases Chapter 7 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an AntigenSpecific Manner................................................................................................................................... 112 Kevin J. Peine, The University of North Carolina at Chapel Hill, USA Naihan Chen, The University of North Carolina at Chapel Hill, USA Eric M. Bachelder, The University of North Carolina at Chapel Hill, USA Kristy M. Ainslie, The University of North Carolina at Chapel Hill, USA Chapter 8 HIV/AIDS Discrimination, Stigmatization, and Denial: A Study in Social Work Perspective........... 141 Yatendra Pal Singh, Lucknow University, India Section 3 Blood Disorders Chapter 9 An Artificial Intelligence Approach to Thrombophilia Risk............................................................... 161 João Vilhena, Universidade de Évora, Portugal Henrique Vicente, Universidade de Évora, Portugal M. Rosário Martins, Universidade de Évora, Portugal José Grañeda, Hospital do Espírito Santo de Évora, Portugal Filomena Caldeira, Hospital do Espírito Santo de Évora, Portugal Rodrigo Gusmão, Hospital do Espírito Santo de Évora, Portugal João Neves, Drs. Nicolas & Asp, UAE José Neves, Universidade do Minho, Portugal Section 4 Cardiovascular Disease Chapter 10 Pharmacogenomics and Cardiovascular Disease................................................................................. 184 Emily K. Dornblaser, University of New England, USA Craig P. Worby, University of New England, USA Daniel Alan Brazeau, University of New England, USA



Chapter 11 Coronary Heart Disease Prognosis Using Machine-Learning Techniques on Patients With Type 2 Diabetes Mellitus................................................................................................................................. 198 Angela Pimentel, FCT-UNL, Portugal Hugo Gamboa, FCT-UNL, Portugal Isa Maria Almeida, APDP-ERC, Portugal Pedro Matos, APDP-ERC, Portugal Rogério T. Ribeiro, APDP-ERC, Portugal João Raposo, APDP-ERC, Portugal Chapter 12 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions in an Aging Population............................................................................................................................ 218 Enoch Chan, University of New South Wales, Australia Sai Wang Seto, Western Sydney University, Australia Tsoi Ming Au Yeung, Hong Kong Community College, Hong Kong Gabriel Hoi Huen Chan, Hong Kong Community College, Hong Kong Section 5 Caregivers and Education Chapter 13 Respite Tourism for Family Caregivers............................................................................................... 242 Robert Holda, Independent Respite Care Specialist, USA Chapter 14 Turning PAGES With Health Coaching and Family Involvement....................................................... 255 Jennifer Lynne Bird, Florida Atlantic University, USA Eric T. Wanner, Palm Beach Sports Medicine & Orthopaedic Center, USA Chapter 15 Knowledge Management for Health Care and Long-Term Care in the Technology-OrganizationEnvironment Context........................................................................................................................... 277 Man Fung Lo, The Hong Kong Polytechnic University, Hong Kong Peggy Mei Lan Ng, The Hong Kong Polytechnic University, Hong Kong Chapter 16 Case Studies of Chronically Ill Children: Implications for Education Professionals.......................... 303 Thomas C. Gibbon, Shippensburg University, USA Christopher L. Schwilk, Shippensburg University, USA Jenifer Cline, Great Falls School District, USA Kimberly Matthews, Independent Researcher, USA Katie Sweigart, Shippensburg University, USA Emily Ferguson, Independent Researcher, USA David F. Bateman, Shippensburg University, USA



Section 6 Diabetes Chapter 17 Analyzing Online Social Support Within the Type 1 Diabetes Community....................................... 338 Kristin G. Maki, University at Buffalo (SUNY), USA Aisha K. O’Mally, University at Buffalo (SUNY), USA Chapter 18 Diabetes Mellitus and Aging............................................................................................................... 359 Jyoti Mishra Pandey, Government Medical College Chandigarh, India Preeti Mishra, SMI Medical College and Hospital, India Chapter 19 Health Guidance Provision Infrastructure for Personalized Diabetes Management: The HealthDiab Solution............................................................................................................................ 378 Kostas Giokas, AiM Research Team, Biomedical Engineering Laboratory, National Technical University of Athens, Greece Dimitra Iliopoulou, AiM Research Team, Biomedical Engineering Laboratory, National Technical University of Athens, Greece Georgia Koutsouri, AiM Research Team, Biomedical Engineering Laboratory, National Technical University of Athens, Greece Dimitris Koutsouris, National Technical University of Athens, Greece Section 7 Kidney Disease Chapter 20 General Approach to Evaluating Beneficial and Adverse Effects of CAM Use in Kidney  Diseases............................................................................................................................................... 397 Mayuree Tangkiatkumjai, Srinakharinwirot University, Thailand Chatchai Kreepala, Srinakharinwirot University, Thailand

Volume II Chapter 21 Coping and Transition in Young People With Chronic Kidney Disease (CKD) – Maintaining Best Practice: Paediatric Nephrology.......................................................................................................... 425 Shahid Muhammad, The Renal Patient Support Group (RPSG), UK Section 8 Mental Illness Chapter 22 Global Burden of Mental Disorders: Quality of Care and Unmet Needs for Treatment of Chronic Mental Illness....................................................................................................................................... 445 Meghamala S. Tavaragi, DIMHANS, India Sushma C., DIMHANS, India



Chapter 23 Psychosocial Intervention Strategies for Patients With Schizophrenia: In Chronic Mental Illness.... 468 Ashwini R., Dharwad Institute of Mental Health and Neurosciences, India Barre Vijay Prasad, Dharwad Institute of Mental Health and Neurosciences, India Srinivas Kosgi, Dharwad Institute of Mental Health and Neurosciences, India Chapter 24 Management of Chronic Mental Illnesses and Substance Use Disorders............................................ 486 Pallavi Sinha, Institute of Human Behaviour and Allied Sciences (IHBAS), India Amit Garg, Institute of Human Behaviour and Allied Sciences (IHBAS), India Prerna Khanna, Pushpanjali Crosslay Hospital, India Amit Khanna, Institute of Human Behaviour and Allied Sciences (IHBAS), India Chapter 25 Chronic Mental Illness in Old Age Homes: An International Perspective.......................................... 509 Shamsi Akbar, King George Medical University – Lucknow, India Hitesh Khurana, Pt. B. D. Sharma PGIMS, India Chapter 26 Comorbidity of Medical and Psychiatric Disorders in Geriatric Population: Treatment and Care..... 528 Pratima Kaushik, Amity University Uttar Pradesh, India Chapter 27 Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment in Child and Adolescent Population................................................................................... 556 Bhavuk Garg, IHBAS, India Prerna Khanna, Pushpanjali Crosslay Hospital, India Amit Khanna, IHBAS, India Chapter 28 Chronic Mental Illness in Prisons: Global Scenario............................................................................ 568 Meghamala S. Tavaragi, Dharwad Institute of Mental Health and Neurosciences, India Section 9 Nerve Disorders and Pain Management Chapter 29 Medical Management of Trigeminal Neuralgia................................................................................... 591 Niushen Zhang, Stanford University, USA Chapter 30 V2 Rhizotomy...................................................................................................................................... 610 Lucas W. Campos, Summit Pain Alliance, USA Nicholas Telischak, Stanford University, USA Huy M. Do, Stanford University, USA Xiang Qian, Stanford University, USA



Chapter 31 Effecting Superior Pain Management Strategies by Combining Technology With Tradition............. 631 CK Foo, Honorary Health Informatics, Australia Chapter 32 Manage My Pain: A Patient-Driven Mobile Platform to Prevent and Manage Chronic Postsurgical Pain...................................................................................................................................................... 642 Aliza Weinrib, Toronto General Hospital, University Health Network, Canada Muhammad Abid Azam, York University, Canada & Toronto General Hospital, University Health Network, Canada Vered Valeria Latman, York University, Canada Tahir Janmohamed, ManagingLife, Canada Hance Clarke, Toronto General Hospital, University Health Network, Canada Joel Katz, York University, Canada & Toronto General Hospital, University Health Network, Canada Section 10 Remote Monitoring, Mobile Health, and Medical Imaging Chapter 33 Chronic Condition Management Using Remote Monitoring and Telehomecare................................ 669 Maximillian E. Stachura, Georgia Regents University, USA Ellen B. Bolch, THA Group, USA Katherine F. Piette, THA Group, USA Joseph F. Ebberwein, THA Group, USA Chapter 34 Towards a Telehomecare in Algeria: Case of Diabetes Measurement and Remote Monitoring......... 687 Karim Zarour, University Constantine 2, Algeria Chapter 35 Virtual Carer: A First Prototype........................................................................................................... 709 Aldo Franco Dragoni, Università Politecnica delle Marche, Italy Chapter 36 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT: Deep Learning AI to the Rescue of Home-Based Healthcare...................................................................................... 720 David Mendes, DECSIS, Portugal Manuel Lopes, Universidade de Évora, Portugal Artur Romão, DECSIS, Portugal Irene Pimenta Rodrigues, Universidade de Évora, Portugal



Chapter 37 Commercial Home Assistance Services.............................................................................................. 737 Milica Milutinovic, K.U.Leuven, Belgium Koen Decroix, Katholieke Hogeschool Sint – Lieven, Belgium Vincent Naessens, Katholieke Hogeschool Sint – Lieven, Belgium Bart De Decker, K.U.Leuven, Belgium Chapter 38 STRIPA: The Potential Usefulness of a Medical App......................................................................... 764 Floor Aarnoutse, Utrecht University, The Netherlands Cassandra Renes, Utrecht University, The Netherlands Ronald Batenburg, Utrecht University, The Netherlands Marco Spruit, Utrecht University, The Netherlands Chapter 39 Performance of Service-Oriented Architecture (SOA): Medical Image Systems for Chronic Diseases............................................................................................................................................... 785 Deepika Dubey, Uttarakhand Technical University, India Deepanshu Dubey, IIFM Bhopal, India Uday Pratap Singh, Madhav Institute of Technology and Science, India Section 11 Spending and Economics Chapter 40 The Economics of Long-Term Care: Key Concepts and Major Financing and Delivery Models....... 803 Peter P. Yuen, The Hong Kong Polytechnic University, Hong Kong Chapter 41 Long-Term Care Spending Relevant to U.S. Medicaid Expansion: Medicaid Long-Term Care Spending.............................................................................................................................................. 821 Mary Schmeida, Kent State University, USA Ramona Sue McNeal, University of Northern Iowa, USA Index...................................................................................................................................................... xx

xiv

Preface

The everchanging landscape surrounding the diverse applications within the medical field can make it very challenging to stay on the forefront of innovative research trends. That is why IGI Global is pleased to offer this two-volume comprehensive reference that will empower students, researchers, practitioners, professionals, and academicians with a stronger understanding of chronic illness and long-term care. This compilation is designed to act as an all-inclusive reference source on conceptual, methodological, and technical aspects, and will provide insight into emerging topics including but not limited to special education, health management, social support, drug delivery, and medical funding. The chapters within this publication are sure to provide readers with the tools necessary for further research and discovery in their respective industries and/or fields. Chronic Illness and Long-Term Care: Breakthroughs in Research and Practice is organized into 11 sections that provide comprehensive coverage of important topics. The sections are: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.

Alzheimer’s Disease and Dementia; Autoimmune Diseases; Blood Disorders; Cardiovascular Disease; Caregivers and Education; Diabetes; Kidney Disease; Mental Illness; Nerve Disorders and Pain Management; Remote Monitoring, Mobile Health, and Medical Imaging; and Spending and Economics.

The following paragraphs provide a summary of what to expect from this invaluable reference source: Section 1, “Alzheimer’s Disease and Dementia,” is comprised of six chapters and opens this extensive reference source by highlighting the latest trends in age-related cognitive impairment prevention, diagnosis, treatment, and confrontation. Through perspectives on social inclusion, assistive technologies, and visual therapy, this section demonstrates the importance of empowering and connecting with patients and their caregivers through recreation and socialization. The presented research facilitates a better understanding of how to aid the development and management of caregiving, and significantly improve the quality of life of Alzheimer’s patients and their families.  

Preface

One of the many in-depth chapters addresses the dramatic impact Alzheimer’s Disease has on society, as well as the importance of understanding and incorporating the needs of those who suffer from Alzheimer’s through cutting-edge technology, special serious games, and natural-user interfacing. Titled “Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support,” the chapter is authored by Profs. Leontios J. Hadjileontiadis, Dimitrios Mandiliotis, Konstantinos Toumpas, and Aikaterini Kyprioti from the Aristotle University of Thessaloniki, Greece. Another chapter within this section is titled “Assistive Technologies and the Carers of People With Dementia: Empowerment and Connection,” authored by Profs. Sarmishtha Bhattacharyya and Susan Mary Benbow from the University of Chester, UK. It discusses techniques in supporting both formal and informal carers of people with dementia, and in maintaining the independence and quality of life of both people with dementia and their carers. Another noteworthy chapter evaluates the usage of an online healthcare portal in providing real-time access to information on telecare alerts and events, as well as enhancing the reputation of the organization. Titled “Integrated eCare in Dementia: The Irish Experience in the INDEPENDENT Project,” the chapter is authored by Ms. Sarah Delaney, Senior Research Consultant, Work Research Centre, Ireland. Section 2, “Autoimmune Diseases,” includes two chapters on maintaining the independence and quality of life for those with autoimmune diseases. Including discussions on drug delivery, discrimination, and social work education, this section presents research on the medical and social needs of HIV positive and AIDS patients. Its comprehensive information assists in fostering social inclusion and increasing quality of life through enhanced medical care. One of the section’s crucial chapters explores the use of microparticulate delivery vehicles for the induction of immune tolerance to increase the efficacy of immune tolerance therapies. Titled “Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner,” it is authored by Profs. Kevin J. Peine, Naihan Chen, Eric M. Bachelder, and Kristy M. Ainslie from the University of North Carolina at Chapel Hill, USA. Another essential chapter, titled “HIV/AIDS Discrimination, Stigmatization, and Denial: A Study in Social Work Perspective,” is authored by Prof. Yatendra Pal Singh from Lucknow University, India. It examines several tools and techniques in preventing problems through diagnosing the causes responsible for maladjustment in society, and the role of social work education for minimizing or removing the stress of HIV positive and AIDS patients. Section 3, “Blood Disorders,” contains one chapter and presents coverage on novel strategies in identifying and treating blood disorders and diseases. Through innovative discussions on artificial neural networks, decision support systems, and computational frameworks, this section highlights the application of diagnosis systems in medical assessment and treatment. Its inclusive perspectives contribute to the available knowledge on identifying the cause of the disease and addressing the most appropriate treatment through medical technologies and computer networks. This section’s single chapter, titled “An Artificial Intelligence Approach to Thrombophilia Risk,” is authored by Profs. João Vilhena, Henrique Vicente, and M. Rosário Martins from the University of Évora, Portugal; Drs. José Grañeda, Filomena Caldeira, and Rodrigo Gusmão from the Hospital do Espírito Santo de Évora, Portugal; Dr. João Neves from Drs. Nicolas & Asp, Dubai, UAE; and Prof. José Neves from the University of Minho, Portugal. The chapter focuses on the development of a diagnosis decision support system, complemented with a computational framework based on artificial neural networks, to assist in the assessment of thrombophilia predisposition.

xv

Preface

Section 4, “Cardiovascular Disease,” is comprised of three chapters and discusses coverage and research perspectives on optimization therapeutics, medications, and medical diagnosis for the treatment of cardiovascular disease. Through analyses on machine learning, genetic variation, and traditional medicine, this section contains pivotal information on providing services to people with cardiovascular disorders and increasing the quality of care. The presented research facilitates a comprehensive understanding of how to better cater to the needs of patients through medical technology and care. One of the section’s many essential chapters is titled “Pharmacogenomics and Cardiovascular Disease.” Authored by Profs. Emily K. Dornblaser, Craig P. Worby, and Daniel Alan Brazeau from the University of New England, USA, it discusses the relationship between genetic variations and their impact on medications used for the treatment of cardiovascular disorders. Additionally, it reviews current clinical literature to determine the overall impact these variations may have on clinical outcomes. Another distinct chapter provides a brief introduction to traditional Chinese medicine and its development in ancient China. It discusses the use of Chinese herbal medicine in the treatment of cardiovascular diseases and the potentials and challenges of incorporating Chinese herbal medicine in the mainstream healthcare system. Titled “Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions in an Aging Population,” it is authored by Prof. Enoch Chan from the University of New South Wales, Australia; Prof. Sai Wang Seto from Western Sydney University, Australia; and Profs. Tsoi Ming Au Yeung and Gabriel Hoi Huen Chan from Hong Kong Community College, Hong Kong. Section 5, “Caregivers and Education,” includes four chapters on the complex issues and techniques surrounding caregiver coaching and practice. Including discussions on medical tourism, knowledge management, and special education, this section presents research on the importance of connecting caregivers and patients, as well as enhancing the effectiveness of care for those with chronic illness. Its inclusive information assists in advancing current practices to support caregivers and their patients. One of the many in-depth chapters is titled “Turning PAGES With Health Coaching and Family Involvement,” and it is authored by Prof. Jennifer Lynne Bird from Florida Atlantic University, USA and Dr. Eric T. Wanner from Palm Beach Sports Medicine & Orthopaedic Center, USA. It introduces the application of the PAGES program in family coaching programs to support the healing process through encouragement and self-care. An additional chapter, titled “Knowledge Management for Health Care and Long-Term Care in the Technology-Organization-Environment Context” and authored by Profs. Man Fung Lo and Peggy Mei Lan Ng from the Hong Kong Polytechnic University, Hong Kong, proposes a framework examining the impacts of technological, organizational, and environmental factors on the adoption of knowledge management in a long-term care context. Additionally, the chapter provides insight to healthcare organization leaders on how to enhance the effectiveness of knowledge management systems in long-term care organizations. Another essential chapter presents case studies of real children and families, allowing readers a personal glimpse into the lives of children with chronic illness and their families, as well as the complex issues surrounding the educational needs of children with chronic illnesses. Titled “Case Studies of Chronically Ill Children: Implications for Education Professionals,” it is authored by Prof. Thomas C. Gibbon from Shippensburg University, USA; Prof. Christopher L. Schwilk from Shippensburg University, USA; Ms. Jenifer Cline, Student Services Coordinator at the Great Falls School District, USA; Prof. Kimberly Matthews, Independent Researcher, USA; Prof. Katie Sweigart, from Shippensburg University, USA; Prof. Emily Ferguson, Independent Researcher, USA; and Prof. David F. Bateman, from Shippensburg University, USA. xvi

Preface

Section 6, “Diabetes,” is comprised of three chapters and presents coverage on different aspects of diabetes and its impact on human life, as well as techniques for healthy treatment and lifestyle. Through innovative discussions on social support, health management, and psychosocial support, this section highlights techniques in managing emotional health, providing various types of support, and integrating technology into the treatment of diabetes. Its insightful subject matter contributes to the available knowledge on reducing treatment costs and risks while improving treatment for diabetes. One of the section’s fundamental chapters covers different aspects of diabetes mellitus and its impact on human life, as well as how healthy coping mechanisms can help prevent the distressing effect of diabetes on aging. Titled “Diabetes Mellitus and Aging,” the chapter is authored by Prof. Jyoti Mishra Pandey from Government Medical College Chandigarh, India and Prof. Preeti Mishra from SMI Medical College and Hospital, India. Another crucial chapter is titled “Health Guidance Provision Infrastructure for Personalized Diabetes Management: The HealthDiab Solution” and is authored by Profs. Kostas Giokas, Dimitra Iliopoulou, Georgia Koutsouri, and Dimitris Koutsouris from the National Technical University of Athens, Greece. It proposes the development of an innovative personal health management system that overcomes the current limitations patients and their physicians find at managing the disease. Additionally, the chapter addresses how a platform could help reduce the risks for the patient by having new comorbidities associated to their disease, while helping decrease the public costs linked with health assistance. Section 7, “Kidney Disease,” includes two chapters and discusses coverage and research perspectives on maintaining physical health, lifestyle, and psychological wellbeing for those with kidney disease. Through analyses on alternative medicine, transition and coping services, and support groups, this section contains pivotal information on maintaining autonomy and wellbeing of patients. The presented research facilitates a comprehensive understanding of technological and medical applications to empower patients with increased quality of care. Another vital chapter within this section is titled “General Approach to Evaluating Beneficial and Adverse Effects of CAM Use in Kidney Diseases,” and it is authored by Profs. Mayuree Tangkiatkumjai and Chatchai Kreepala from Srinakharinwirot University, Thailand. The chapter addresses the issue of evaluating the benefits and nephrotoxicity of complementary and alternative medicine in chronic kidney disease, dialysis therapy, kidney transplantation, and urolithiasis, as well as the measurement of humanistic outcomes. An additional chapter, titled “Coping and Transition in Young People With Chronic Kidney Disease (CKD): Maintaining Best Practice – Paediatric Nephrology,” is authored by Prof. Shahid Muhammad from the Renal Patient Support Group (RPSG), UK and explores the need for a transition reorganization to maintain the best practices for young people with chronic kidney disease and effective coping and transition research for the future. The chapter also addresses the importance of overall transition guidelines and reorganizations that factor in coping strategies for teams supporting the care for young people. Section 8, “Mental Illness,” is comprised of seven in-depth chapters on the economic, political, and health-related implications of mental health treatment. Including discussions on group therapy, substance abuse, and medical intervention, this section presents research that addresses suffering, economic loss, and social problems in mental health issues, as well as providing better mental health programs and guidelines. The diverse coverage assists in the rehabilitation, diagnosis, and treatment of mental illness. One of the section’s many in-depth chapters is titled “Chronic Mental Illness in Old Age Homes: An International Perspective.” Authored by Prof. Shamsi Akbar from King George’s Medical University, India and Prof. Hitesh Khurana from Pt. B. D. Sharma PGIMS, India, the chapter discusses the need xvii

Preface

to develop suitable strategies to implement better mental health programs and guidelines for chronic mental illness in homes for the aged. Another vital chapter proposes the concepts and issues related to comorbidity in the geriatric population, as well as the consequences of medical and psychiatric comorbidities, their effective treatment regime, and care and management in relation to the geriatric population. Titled “Comorbidity of Medical and Psychiatric Disorders in Geriatric Population: Treatment and Care,” the chapter is authored by Prof. Pratima Kaushik from Amity University Uttar Pradesh, India. An additional chapter discusses the clinical features, courses, outcomes, and treatment strategies of chronic mental illness in children, with a focus on schizophrenia and bipolar mood disorder diagnosis and treatment. It is titled “Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment in Child and Adolescent Population,” and it is authored by Dr. Bhavuk Garg from IHBAS, India; Dr. Prerna Khanna from Pushpanjali Crosslay Hospital, India; and Dr. Amit Khanna from IHBAS, India. Section 9, “Nerve Disorders and Pain Management,” presents four chapters on medical therapies and treatment strategies in treating and managing pain and nerve disorders. Through innovative discussions on mobile technologies, preventive strategies, and medical management, this section highlights the needs of people living with pain, healthcare providers, and strategies in delivering better health services. The perspectives contribute to the available knowledge on patient engagement, motivation, and satisfaction in pain and nerve treatment. One fundamental chapter, titled “V2 Rhizotomy,” summarizes common ablation techniques targeting the V2 branch of the trigeminal nerve to help medical management of pain for trigeminal neuralgia. The chapter also discusses procedures that help avoid exposure to general anesthesia, provide successful short-term results, and are available to people with significant comorbidities. It is authored by Prof. Lucas W. Campos from Summit Pain Alliance, USA and Profs. Nicholas Telischak, Huy M. Do, and Xiang Qian from Stanford University, USA. Another noteworthy chapter within this section highlights strategies for prudent pain management, particularly through combining modern technology with ancient wisdom and traditional approaches. The chapter’s alternate strategies aim to help relieve symptoms and reduce or eliminate discomfort in pain management. Titled “Effecting Superior Pain Management Strategies by Combining Technology With Tradition,” it is authored by Prof. C. K. Foo from Honorary Health Informatics, Australia. An additional chapter within this section is titled “Manage My Pain: A Patient-Driven Mobile Platform to Prevent and Manage Chronic Postsurgical Pain,” and it is authored by Dr. Aliza Weinrib from Toronto General Hospital, Ontario, Canada; Prof. Muhammad Abid Azam, from York University, Ontario, Canada and Toronto General Hospital, Ontario, Canada; Prof. Vered Valeria Latman from York University, Ontario, Canada; Mr. Tahir Janmohamed, CEO of ManagingLife, Canada; Dr. Hance Clarke from Toronto General Hospital, Ontario, Canada; and Prof. Joel Katz from York University, Ontario, Canada and Toronto General Hospital, Ontario, Canada. The chapter describes the Manage My Pain digital pain management platform and its integration into the transitional pain service at Toronto General Hospital, as well as the creation of a patient-provider virtual community with the aim of managing complex pain after surgery. Additionally, the chapter discusses user engagement, motivation, and satisfaction. Section 10, “Remote Monitoring, Mobile Health, and Medical Imaging,” is comprised of seven chapters that include coverage and research perspectives on establishing and maintaining connections between healthcare providers and patients through mobile medical technologies and services. Through analyses on information privacy, medical support systems, and interactive communication, this section xviii

Preface

contains pivotal information on new organizational and financial approaches that repurpose health professional roles, responsibilities, and relationships. The presented research facilitates a comprehensive understanding of the provision of personalized and real-time guidance through mobile health systems. One of the section’s many valuable chapters describes an architectural framework for the development of telehomecare in Algeria for diabetes measurement and remote monitoring, as well as valuable tools used to establish and maintain connections within and between healthcare providers, and between healthcare providers and patients. Titled “Towards a Telehomecare in Algeria: Case of Diabetes Measurement and Remote Monitoring,” the chapter is authored by Prof. Karim Zarour from University Constantine 2, Algeria. Another significant chapter, titled “Virtual Carer: A First Prototype,” authored by Prof. Aldo Franco Dragoni from Marche Polytechnic University, Italy, discusses the design of an innovative and comprehensive information system for ambient assisted living that constantly monitors health warnings, informs and advises the elderly, controls the environment, and asks for help when needed. Additionally, the chapter defines the actions and policies needed to promote the improvement of living conditions within domestic spaces to foster autonomy, safety, and social inclusion for the elderly or disabled. Another noteworthy chapter examines the effectiveness of a medical app for polypharmacy patients to reduce the risk of morbidity, mortality, and medication risks. Titled “STRIPA: The Potential Usefulness of a Medical App,” the chapter is authored by Profs. Floor Aarnoutse, Cassandra Renes, Ronald Batenburg, and Marco Spruit from Utrecht University, The Netherlands. Section 11, “Spending and Economics,” includes two chapters on the key concepts of economics relevant to the financing, funding, and delivery of long-term care services. Including discussions on developed economies, nursing facilities, and financial incentives, this section presents research on the demand, supply, and financing of healthcare services, as well as funding obligations and recent recessions. The inclusive information assists in advancing current practices in policies, practices, and major models in healthcare finances. One of the essential chapters within this section is titled “The Economics of Long-Term Care: Key Concepts and Major Financing and Delivery Models.” It is authored by Prof. Peter P. Yuen from the Hong Kong Polytechnic University, Hong Kong and presents key concepts of economics relevant to the financing and delivery of long-term care services. Also, it examines the magnitude of the aging population in developed economies and the associated implications for long-term care. Additionally, it discusses policies and major models of financing for long-term care and a conceptual framework for reform. The other chapter in this section is titled “Long-Term Care Spending Relevant to U.S. Medicaid Expansion: Medicaid Long-Term Care Spending,” and it is authored by Prof. Mary Schmeida from Kent State University, USA and Prof. Ramona Sue McNeal from the University of Northern Iowa, USA. It explores the use of regression analysis and state-level data and why some states spend more revenue on nursing facility long-term care despite enhanced federal funding to reform while others are spending more on home and community-based services. Although the primary organization of the contents in this work is based on its 11 sections, offering a progression of coverage of the important concepts, methodologies, technologies, applications, social issues, and emerging trends, the reader can also identify specific contents by utilizing the extensive indexing system listed at the end.

xix

Section 1

Alzheimer’s Disease and Dementia

1

Chapter 1

The Impact of Decline on Everyday Life in Alzheimer’s Disease Lovingly Quitania Park Azusa Pacific University, USA Britt Busson Azusa Pacific University, USA

ABSTRACT The loss of independence is a quintessential feature of dementia and important to the clinical diagnosis of Alzheimer’s disease (AD). However, changes in memory and other cognitive abilities can significantly influence the rate and the trajectory of decline in everyday life. The goal of this chapter is to provide the reader with a picture of how the cognitive and emotional changes associated with AD can alter daily living in the early-to-moderate stages and the subsequent psychosocial impacts. Practical suggestions with regard to management of AD by the affected individual and supporters are offered, as are some suggestions for addressing completion of daily tasks, such as finances, medications, appointments, and transportation.

INTRODUCTION When Ronald Regan announced his challenge with Alzheimer’s disease (AD) in 1994, he said, “I now begin the journey that will lead me into the sunset of my life.” Throughout the lifespan, few people prepare for the emotional and physical challenges they may face with aging, and rarely does anyone prepare for his or her own cognitive decline. The effects of memory decline are taxing on all aspects of an individual’s emotional, social, and physical health. With a diagnosis of dementia, one faces inevitable changes in the ability to carry out normal and regular activities of daily living and a subsequent loss of independence. With regard to the specific characteristics and effects of AD, the goal of this chapter is to provide a brief overview of how memory loss as well as emotional and behavioral changes can interfere with daily life in the early-to-moderate stages, and how subsequent challenges can be recognized and addressed. DOI: 10.4018/978-1-5225-7122-3.ch001

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 The Impact of Decline on Everyday Life in Alzheimer’s Disease

BACKGROUND AD is the most common neurodegenerative disorder leading to dementia among adults 65 years of age and older (Alzheimer’s Association, 2014). Researchers have estimated that annual direct care costs, including health care and long-term care payments, for AD in the United States totaled approximately $214 billion in 2013 and will rise to $1.2 trillion by 2050 (Alzheimer’s Association, 2014). Additionally, across the United States, 15.5 million caregivers provided 177 billion hours of unpaid care, valued at over $220 billion, to address the daily health, social, emotional, and basic care needs of loved ones with dementia. AD is characterized by disturbances in an individual’s ability to learn and remember new information that reflects deterioration of medial temporal structures of the brain, including the hippocampus (Carmichael et al., 2012; Rabinovici et al., 2007). As AD neuropathology becomes more diffusely distributed throughout the brain, other cognitive impairments eventually emerge in visuospatial abilities, language, and executive function (Kramer et al., 2005; Melrose et al., 2011; Melrose, Harwood, Khoo, Mandelkern, & Sultzer, 2013; Mungas et al., 2001). Consequently, the cognitive, emotional, and behavioral changes that occur often result in a significant decline in the ability to execute everyday tasks, otherwise known as functional decline (Farias, Chou, et al., 2013; Farias, Park, et al., 2013). In the literature, discussions of functional impairments in AD are generally limited to examining composite indices of daily function related to activities of daily living (ADLs) that are basic (e.g., grooming, bathing, and feeding), instrumental (IADLS) (e.g., using transportation, managing finances, and keeping appointments), or in some cases a combination of both. It is also widely accepted that specific daily abilities are related to distinct cognitive domains affected by neurodegenerative conditions such as AD (Kahle-Wrobleski et al., 2014; Winblad, Gauthier, Astrom, & Stender, 2010). Older adults can experience a variety of subtle and periodic changes in daily function. Changes in everyday functioning are of concern when they become noticeable to others and represent a significant change from past performance. Investigating alterations in the ability to engage in daily tasks is critical as these changes can actually be an early indicator of AD (Purser, Fillenbaum, Pieper, & Wallace, 2005). Treating functional decline in AD is gaining wide acceptance in the literature (Choi & Twamley, 2013; Dysken et al., 2014; Winblad, Gauthier, Astrom, & Stender, 2010). Medications and psychosocial interventions to treat the cognitive and behavioral consequences of AD can help facilitate independence. Understanding how the person adapts to changes in daily life within the context of AD can lead to improvements in everyday function that enhance quality of life for both affected individuals and their caregivers.

THE RELATIONSHIP BETWEEN COGNITION AND EVERYDAY FUNCTION Recent literature has shown that there are longitudinal changes in thinking that correspond to how people function in daily life (Artero, Touchon, & Ritchie, 2001; Farias et al., 2013). In mild cognitive impairment (MCI), a high-risk pre-dementia state, changes in memory and/or other thinking abilities are noticeable, but the affected can adapt in ways that enable them to successfully complete daily tasks, precluding a diagnosis of dementia (Farias et al., 2008). Mild memory changes in MCI involve benign instances of forgetfulness in daily life. Existing hypotheses postulate that when executive functioning remains intact in MCI, the individual is able to come up with creative solutions to compensate for forgetfulness (Pereira, Yassuda, Oliveira, & Forlenza, 2008). 2

 The Impact of Decline on Everyday Life in Alzheimer’s Disease

Executive functioning is often referred to as someone’s ability to engage in complicated, goal-directed behavior, such as organizing paperwork in order to pay bills on time. When executive functioning remains relatively preserved, cognitively impaired individuals can reduce complicated tasks into manageable steps and accomplish things like planning a dinner. This ability to compensate may be seen in persons with MCI or early AD and explain why memory is the primary driver of everyday function early on (Farias, Chou, et al., 2013; Farias, Park, et al., 2013). In the moderate stages of AD, executive deficits are more predictive than memory impairment of daily life in dementia (Boyle, et al., 2004).

THE IMPACT OF EMOTIONS AND BEHAVIOR ON EVERYDAY FUNCTION Cognition alone does not explain how well people function in their everyday lives. Behavioral syndromes can occur within the context of many neurodegenerative conditions and may even emerge years before a diagnosis of dementia is apparent (Palmer et al., 2008). Apathy, defined as a loss of interest and decreased motivation, is a common early symptom of AD (Boyle & Malloy, 2004). Apathy and other behaviors are just as problematic as cognitive decline, and they are often a source of significant caregiver distress due to their widespread impact across different daily activities (Rog et. al., 2014; Sadak, Katon, Beck, Cochrane, & Borson, 2014). For instance, attending appointments, using public transportation, and even things like planning a party all require initiation and the ability to follow through with completing the task (Rog et. al., 2014). With the gradual loss of independence, including the diminished ability to drive, shop for groceries, and socialize with friends, many people with AD experience uncharacteristic changes in mood and behavior. Some changes in behavior can be voluntary in someone with AD and may represent an expression of unmet need that requires attention of a caregiver. When someone notices changes in the thinking abilities of a person with AD, the impaired individual is apt to alter the way he or she behaves in everyday life. For example, someone who has difficulty following conversations and remembering recent events is less likely to engage in interactions with friends. While this might appear as if the person with AD is withdrawn, one ought to consider that these behaviors are often reactions to the cognitive deficits the individual is experiencing. In fact, these behaviors might also reflect feelings of embarrassment and a need for compensatory support to function in social situations. Others with AD become creative and harness their social skills to deflect conversations so they do not have to respond as often. Then there are some with AD who may attempt to minimize symptoms by attributing them to fatigue or external factors. And, yet others will openly discuss their changing abilities as long as insight and language are preserved. Regardless of the person’s approach, it is important to keep in mind that all of these behaviors are adaptive and allow the individual to function in social situations without compromising dignity in front of others. Let us take the example of a 78-year-old veteran, the first of four cases shared in this chapter. He was brought in by his adult son for an evaluation. Among other things the son reported, he expressed concern that his father was withdrawing and appeared to be depressed. The son stated that he had encouraged his father to attend social outings, but to no avail. As such, the son was becoming frustrated at what he perceived as “stubbornness.” However, asking the father about the changes his son had reported revealed an entirely different slant to the story. Before being diagnosed with AD, the father was the center of attention among his friends and someone others could look to if they needed help. As his memory worsened, he began to forget conversations with his friends and their appointments for coffee and golf. 3

 The Impact of Decline on Everyday Life in Alzheimer’s Disease

He once made an error while helping someone with a simple house repair. He began to feel embarrassed and useless, feelings that led to his decision to minimize interactions with others. Given the multiples losses AD brings, the affected are at higher risk of developing symptoms of depression (Innes & Selfe, 2014). Decreased self-efficacy in the once-capable individual can exacerbate feelings of sadness and hopelessness, and those who are more aware of their deficits are at increased risk of developing mood disorders (Horning, Melrose, & Sultzer, 2014). Due to increasing isolation and inability to engage in many previously enjoyed activities, the emergence of depression and loneliness can attenuate the trajectory of AD and lead to faster rates of decline (Holwerda et al., 2014). Depression is an important target of intervention, given the high rate of suicide among older Americans, and can be effectively treated through medications and/or psychological interventions (Baron, Ulstein, & Werheid, 2014; Kjolseth, Ekeberg, & Steihaug, 2010). Persons with AD may not understand or have the awareness to know why they are not able to do the things they used to. While insight can be relatively preserved in the earlier stages of dementia, it eventually dissipates as the disease progresses (Horning et al., 2014; Mangone et al., 1991; McDaniel, Edland, & Heyman, 1995). Although lack of awareness can be frustrating to others, it can also be a blessing to those with AD and contribute significantly to lower levels of depression (Horning et al., 2014). Given these findings, caregivers might work collaboratively with loved ones who have AD to find alternative ways to complete an activity or perhaps alter daily routines to ensure success and maintain a sense of self-efficacy. There is also significant evidence to suggest that the emotional and behavioral changes that emerge in AD have biological underpinnings and ought not always to be interpreted as willful or intentional (Perri, Monaco, Fadda, Caltagirone, & Carlesimo, 2014; Stout, Wyman, Johnson, Peavy, & Salmon, 2003). Therefore, a collaborative approach should be taken with someone who has AD in order to derive solutions that can promote success in completing everyday activities.

ASSESSMENT OF EVERYDAY FUNCTIONING Some people notice changes in their ability to engage in daily activities years before a diagnosis of AD is even considered (Okonkwo et al., 2009). As noted in the first case above, it can be especially frustrating to a person with AD when others attribute subtle changes in daily function to “getting old” or environmental factors. As such, a thorough assessment of functioning in everyday life can be helpful in (a) delineating exactly where difficulties lie, (b) identifying areas of intervention, and (c) ruling out other causes of impairment. Validating the person’s memory complaints through a thorough assessment enables the individual to think of alternative strategies for simply getting through the day (Hurt et al., 2010). There are many different methods of assessing daily function, including in-vivo assessments of daily tasks, interviews with friends or caregivers, and/or patient self-report (Koskas et al., 2014; Leicht & Gertz, 2009). All these methods have different advantages and disadvantages with regard to validity and even cost. Live assessments of the person’s functioning while engaged in tasks such as bill-paying and making appointments can yield meaningful results, but some of these approaches are not entirely representative of real-world functioning. It is not feasible for clinicians to follow their patients around in the community, and in simulations, the environments are structured and not representative of the real world. Self-report measures are useful to understand what the patient is experiencing but may not paint an entirely accurate picture when it comes to specific actions and behaviors at home or in the community, given the progressive loss of insight AD (Farias, Mungas, & Jagust, 2005). 4

 The Impact of Decline on Everyday Life in Alzheimer’s Disease

In a second case example, a 68-year-old woman with moderate AD had family members who complained about her inability to maintain a tidy household. They reported that she was accumulating trash, taking used containers, washing them out, and putting them in bags. This behavior escalated to the point that there was no space to walk in her room. In response to these complaints, the patient simply said that she was in fact keeping the house clean, as the containers were washed thoroughly and placed in her room, separate from the rest of the house. This case illustrates how behaviors that are perceived as “difficult” by others may seem perfectly rational to someone with AD. Without the children’s report in the above example, the explanation provided by the patient would have seemed reasonable. Therefore, it is widely accepted that the preferred method of assessing everyday function is through informant interviews with people who know the patient best. Caregivers, family members, close friends, or others in the community are often asked about the daily functioning of someone with AD. Informant interviews are likely to yield more accurate representations of what is happening from day-to-day (Farias et al., 2005; Heun, Muller, & Papassotiropoulos, 1998). However, it is widely recognized that multiple factors can influence informant ratings. One of these is level of caregiver distress (Davis, 2001). Those who are immersed in caring for someone with AD are at higher risk of health problems, financial strain, and depression (Covinsky et al., 2003; Givens, Mezzacappa, Heeren, Yaffe, & Fredman, 2014; Schulz & Beach, 1999). It is easy to imagine how physical, emotional, and financial strain could negatively color caregiver reports about the functioning of a loved one with AD in daily life and lead to inaccurate representations of how the affected individual is actually doing. As there is no perfect way of measuring decline in daily life, it is always preferable to conduct a multi-modal assessment of how someone is doing so in order to formulate an action plan that is both feasible and helpful to the patient and those around them.

PSYCHOSOCIAL CONSEQUENCES OF FUNCTIONAL DECLINE IN AD Declines in everyday function are associated with higher levels of caregiver burden and health care utilization, as well as reduced quality of life for the individual and their loved ones (Hope, Keene, Gedling, Fairburn, & Jacoby, 1998; Sadak, Katon, Beck, Cochrane, & Borson, 2014; Severson et al., 1994). Psychosocial implications such as stigma, shame, and social exclusion/isolation are common to the experience of those diagnosed with AD and often coincide with impairments in everyday functioning. As a once-capable and independent person, this loss can further exacerbate emotional and cognitive symptoms associated with the disease. For example, persons with AD may experience concerns about being a burden to caregivers and extended family, which can result in a reluctance to ask for help. Current research focuses on the toll AD takes on caregivers, and only recently have there been studies on how independent functioning in the community can be improved in AD (Brotman & Yaffe, 1994; Covinsky et al., 2003; Covinsky & Yaffe, 2004; Givens, Mezzacappa, Heeren, Yaffe, & Fredman, 2014; Hampstead, Mosti, & Swirsky-Sacchetti, 2014; Mahoney, Regan, Katona, & Livingston, 2005; Vreugdenhil, Cannell, Davies, & Razay, 2012). By addressing concerns such as embarrassment and difficulty communicating wants and needs, as well as other stressors that decrease quality and satisfaction in interpersonal relationships, many of the psychosocial effects of AD may be alleviated. The financial impact of AD is also a source of stress for both persons with AD and their families, and this is particularly true for those who are afflicted with the disease prior to retirement age. When the person with early-onset AD is no longer able to work, the loss of income can leave the individual and family struggling to make ends meet. 5

 The Impact of Decline on Everyday Life in Alzheimer’s Disease

In a third case example, a 58-year-old woman who had previously worked in the banking industry came in for an evaluation with her husband and two adult children. The couple, with their dual incomes, worked hard to meet their financial obligations, including putting two children through college, a mortgage, and car payments. When the mother began having memory problems in her early 50s, the family attributed this to menopause. However, two years later her symptoms had escalated to such a degree that she had to quit working. She became unable function without the help of others. This became increasingly burdensome to her husband who took on a second job in order to maintain the family’s standard of living and pay for his children’s college education. In addition to losing the mother’s income, the family was not able to obtain student aid and loans sufficient to entirely cover tuition expenses. But this became the least of the family’s worries. Their concerns turned to making sure Mom would eat during the day, keeping her safe from wandering outside of the neighborhood, and preparing financially for the day when they could no longer care for her at home. Eventually, one of the children put college on hold to help care for the mother and save on the costs of education. Such problems are basic and fundamental issues that people with AD and their families have to face on a daily basis. The modest financial support provided by government programs can help ease some of the burden but is often not enough to cover the monetary consequences of AD (Moschetti et al., 2014). Unfortunately, everyday things, such as food, safety, and shelter, all come at a financial and emotional cost. When someone is diagnosed with AD, their world dwindles as interactions with others are reduced. Some with AD may feel ashamed about their cognitive problems and prefer not to expose their weaknesses to others. They may also fear becoming a burden to families or loved ones. This concern can be even worse among those who have early-onset AD because many social and health care programs are not designed to assist those who are younger than 65 (Moschetti et al., 2014). Additionally, persons with early-onset AD may lack a sense of community as they often feel out of place among others with AD who are 10, 20, or more years their senior. As such, finding tailored ways to increase social interactions among persons with AD at any age should be an important focus of intervention.

CONCLUSION Many with dementia are resilient, and some can call upon creative coping strategies to get by in their daily life and prolong progression to complete disability. Such strategies can include intact social graces, strong problem-solving skills, and even personality characteristics associated with conscientiousness. The final case example highlights an 82-year-old man who was referred for an evaluation by his primary care physician. He was living alone and noticeably forgetting important medical information that was being relayed to him during his appointments. The results of his evaluation indicated that he was in the moderate stages of dementia. But his social graces and interpersonal skills were still very much intact. He was gregarious and had the ability to redirect conversation so that anyone could easily share stories. He had been widowed for many years, had no living relatives, and did not drive. The clinicians wondered how this gentleman managed to get by while living alone. It was discovered that he had many relative strengths, and his social graces enabled him to elicit the help of others. For example, he managed his finances through a young teller at the bank. Since he had no means of transportation, he often invited his friends out for lunch so that they could make “stops” at the grocery store or for appointments, enabling him to take care of his affairs.

6

 The Impact of Decline on Everyday Life in Alzheimer’s Disease

In the example above, the gentleman was able to identify ways in which he could get his needs met while also maintaining important social contacts. Many with AD are able to harness strengths to engage in tasks and accomplish daily goals. Clinicians and loved ones can employ creative and useful strategies to help someone with AD cope with the changes in their daily function and identify effective compensatory strategies. For example, setting alarms to remember appointments and medications, diligently keeping to-do lists, following daily routines, and structuring environments can help keep days predictable. In addition to creating opportunities for social interaction, physical exercise has been linked to improvements in functional abilities (Toro et al., 2014). In fact, there are some who believe that gains from exercising extend far beyond physical health benefits. A recent study found that those who engage in daily cardiovascular exercise for as little as 30 minutes have demonstrable improvements in cognition and daily function only after four months (Vreugdenhil, Cannell, Davies, & Razay, 2012). Attending group classes and community centers for cognitive, physical, and emotional stimulation can benefit the overall health and well-being of the person with AD. Advances in technology have the potential to help individuals with AD remain independent by automating tasks such as bill paying. As well, technology can ease stress on caregivers through, for example, monitoring systems that track the physical whereabouts of loved ones who are at risk for becoming lost outside of their homes. Some families take advantage of free videoconferencing abilities to monitor a loved one’s activities at home during the day. More importantly, safety interventions (e.g., stove timers, reminders to check door locks and turn off running water) should always be a priority since persons whose insight has been compromised by AD are at increased risk of dangerous situations (Starkstein, Jorge, Mizrahi, Adrian, & Robinson, 2007). In particular, cooking and meal preparation involve multiple safety risks (e.g., using knives, leaving on the stove). In the current age of organic and healthy eating, there are a number of organizations and commercial companies that deliver healthy meals to one’s doorstep. Groceries can be put on auto-delivery through the large supermarket chains. While only a few examples of possible interventions to help promote independence in people with AD have been reviewed here, organizations such as the Alzheimer’s Association (www.alz.org) can provide additional strategies for improving daily function and ensuring safety, as well as support for caregivers. Support groups are available to persons with AD as well as for caregivers, as it is important that both are able to share their experiences with others facing the same situation. In conclusion, there are several factors, including memory and other cognitive impairments as well as emotional and behavioral issues, underlying everyday function in AD. Most importantly, focusing on the person who is living with a neurodegenerative disease rather than solely on the condition and its multiple impacts can help ensure that any suggested compensatory strategies are suited to the individual and will be implemented. Helping to promote an individual’s sense of self-efficacy across multiple aspects of daily life may significantly improve his or her overall sense of well-being and alleviate caregiver burden.

REFERENCES 2014 Alzheimer’s disease facts and figures. (2014). Alzheimer’s & Dementia, 10(2), e47–e92. doi:10.1016/j. jalz.2014.02.001 PMID:24818261 Facts and figures. (2014). American Foundation for Suicide Prevention. Retrieved from https://www. afsp.org/understanding-suicide/facts-and-figures

7

 The Impact of Decline on Everyday Life in Alzheimer’s Disease

Artero, S., Touchon, J., & Ritchie, K. (2001). Disability and mild cognitive impairment: A longitudinal population-based study. International Journal of Geriatric Psychiatry, 16(11), 1092–1097. doi:10.1002/ gps.477 PMID:11746656 Baron, S., Ulstein, I., & Werheid, K. (2014). Psychosocial interventions in Alzheimer’s disease and amnestic mild cognitive impairment: Evidence for gender bias in clinical trials. Aging & Mental Health, 1–16; [Advance online publication]. doi:10.1080/13607863.2014.938601 PMID:25048626 Boyle, P. A., & Malloy, P. F. (2004). Treating apathy in Alzheimer’s disease. Dementia and Geriatric Cognitive Disorders, 17(1-2), 91–99. doi:10.1159/000074280 PMID:14564128 Brotman, S. L., & Yaffe, M. J. (1994). Are physicians meeting the needs of family caregivers of the frail elderly? Canadian Family Physician Medecin de Famille Canadien, 40, 679–685. PMID:8199520 Carmichael, O., Xie, J., Fletcher, E., Singh, B., DeCarli, C., & Alzheimer’s Disease Neuroimaging, I. (2012). Localized hippocampus measures are associated with Alzheimer pathology and cognition independent of total hippocampal volume. Neurobiology of Aging, 33, 1124 e1131-1141. doi: 10.1016/j. neurobiolaging.2011.08.016 Choi, J., & Twamley, E. W. (2013). Cognitive rehabilitation therapies for Alzheimer’s disease: A review of methods to improve treatment engagement and self-efficacy. Neuropsychology Review, 23(1), 48–62. doi:10.100711065-013-9227-4 PMID:23400790 Covinsky, K. E., Newcomer, R., Fox, P., Wood, J., Sands, L., Dane, K., & Yaffe, K. (2003). Patient and caregiver characteristics associated with depression in caregivers of patients with dementia. Journal of General Internal Medicine, 18(12), 1006–1014. doi:10.1111/j.1525-1497.2003.30103.x PMID:14687259 Davis, L. L. (2001). Assessing functional ability in persons with dementia: Using family caregivers as informants. Journal of Neuroscience Nursing, 33, 194-195, 200-192. Dysken, M. W., Sano, M., Asthana, S., Vertrees, J. E., Pallaki, M., Llorente, M., & ... (2014). Effect of vitamin E and memantine on functional decline in Alzheimer disease: The TEAM-AD VA cooperative randomized trial. Journal of the American Medical Association, 311, 33–44. doi:10.1001/jama.2013.282834 PMID:24381967 Farias, S. T., Chou, E., Harvey, D. J., Mungas, D., Reed, B., DeCarli, C., & ... (2013). Longitudinal trajectories of everyday function by diagnostic status. Psychology and Aging, 28(4), 1070–1075. doi:10.1037/ a0034069 PMID:24364409 Farias, S. T., Mungas, D., & Jagust, W. (2005). Degree of discrepancy between self and other-reported everyday functioning by cognitive status: Dementia, mild cognitive impairment, and healthy elders. International Journal of Geriatric Psychiatry, 20(9), 827–834. doi:10.1002/gps.1367 PMID:16116577 Farias, S. T., Park, L. Q., Harvey, D. J., Simon, C., Reed, B. R., Carmichael, O., & Mungas, D. (2013). Everyday cognition in older adults: Associations with neuropsychological performance and structural brain imaging. Journal of the International Neuropsychological Society, 19(04), 430–441. doi:10.1017/ S1355617712001609 PMID:23369894

8

 The Impact of Decline on Everyday Life in Alzheimer’s Disease

Givens, J. L., Mezzacappa, C., Heeren, T., Yaffe, K., & Fredman, L. (2014). Depressive symptoms among dementia caregivers: Role of mediating factors. The American Journal of Geriatric Psychiatry, 22(5), 481–488. doi:10.1016/j.jagp.2012.08.010 PMID:23567432 Hampstead, B. M., Mosti, C. B., & Swirsky-Sacchetti, T. (2014). Cognitively-based methods of enhancing and maintaining functioning in those at risk of Alzheimer’s disease. Journal of Alzheimer’s Disease, 42, S483–S493. doi:10.3233/JAD-141476 PMID:25114085 Heun, R., Muller, H., & Papassotiropoulos, A. (1998). Differential validity of informant-based diagnoses of dementia and depression in index subjects and in their first-degree relatives. Social Psychiatry and Psychiatric Epidemiology, 33(10), 510–513. doi:10.1007001270050087 PMID:9780815 Holwerda, T. J., Deeg, D. J., Beekman, A. T., van Tilburg, T. G., Stek, M. L., Jonker, C., & Schoevers, R. A. (2014). Feelings of loneliness, but not social isolation, predict dementia onset: Results from the Amsterdam Study of the Elderly (AMSTEL). Journal of Neurology, Neurosurgery, and Psychiatry, 85(2), 135–142. doi:10.1136/jnnp-2012-302755 PMID:23232034 Hope, T., Keene, J., Gedling, K., Fairburn, C. G., & Jacoby, R. (1998). Predictors of institutionalization for people with dementia living at home with a carer. International Journal of Geriatric Psychiatry, 13, 682–690. doi:3.0.CO;2-Y10.1002/(SICI)1099-1166(1998100)13:10 Horning, S. M., Melrose, R., & Sultzer, D. (2014). Insight in Alzheimer’s disease and its relation to psychiatric and behavioral disturbances. International Journal of Geriatric Psychiatry, 29(1), 77–84. doi:10.1002/gps.3972 PMID:23671016 Hurt, C. S., Banerjee, S., Tunnard, C., Whitehead, D. L., Tsolaki, M., Mecocci, P., & ... (2010). Insight, cognition and quality of life in Alzheimer’s disease. Journal of Neurology, Neurosurgery, and Psychiatry, 8(3), 331–336. doi:10.1136/jnnp.2009.184598 PMID:19828481 Innes, K. E., & Selfe, T. K. (2014). Meditation as a therapeutic intervention for adults at risk for Alzheimer’s disease - potential benefits and underlying mechanisms. Frontiers in Psychiatry, 5, 40. doi:10.3389/fpsyt.2014.00040 PMID:24795656 Kahle-Wrobleski, K., Coley, N., Lepage, B., Cantet, C., Vellas, B., Andrieu, S., & Plasa Dsa, G. (2014). Understanding the complexities of functional ability in Alzheimer’s disease: More than just basic and instrumental factors. Current Alzheimer Research, 11(4), 357–366. doi:10.2174/15672050116661403 17101419 PMID:24635843 Kjolseth, I., Ekeberg, O., & Steihaug, S. (2010). Why suicide? Elderly people who committed suicide and their experience of life in the period before their death. International Psychogeriatrics, 22(02), 209–218. doi:10.1017/S1041610209990949 PMID:19747423 Koskas, P., Henry-Feugeas, M. C., Feugeas, J. P., Poissonnet, A., Pons-Peyneau, C., Wolmark, Y., & Drunat, O. (2014). The Lawton Instrumental Activities Daily Living/Activities Daily Living Scales: A sensitive test to Alzheimer disease in community-dwelling elderly people? Journal of Geriatric Psychiatry and Neurology, 27(2), 85–93. doi:10.1177/0891988714522694 PMID:24578460

9

 The Impact of Decline on Everyday Life in Alzheimer’s Disease

Kramer, J. H., Rosen, H. J., Du, A. T., Schuff, N., Hollnagel, C., Weiner, M. W., & ... (2005). Dissociations in hippocampal and frontal contributions to episodic memory performance. Neuropsychology, 19(6), 799–805. doi:10.1037/0894-4105.19.6.799 PMID:16351355 Leicht, H., & Gertz, H. J. (2009). Methods for assessing impaired insight in Alzheimer’s disease--a critical review. Psychiatrische Praxis, 36, 58–66. doi:10.1055-2008-1067433 PMID:18726844 Mahoney, R., Regan, C., Katona, C., & Livingston, G. (2005). Anxiety and depression in family caregivers of people with Alzheimer disease: The LASER-AD study. The American Journal of Geriatric Psychiatry, 13(9), 795–801. doi:10.1097/00019442-200509000-00008 PMID:16166409 Mangone, C. A., Hier, D. B., Gorelick, P. B., Ganellen, R. J., Langenberg, P., Boarman, R., & Dollear, W. C. (1991). Impaired insight in Alzheimer’s disease. Journal of Geriatric Psychiatry and Neurology, 4(4), 189–193. doi:10.1177/089198879100400402 PMID:1789906 McDaniel, K. D., Edland, S. D., & Heyman, A. (1995). Relationship between level of insight and severity of dementia in Alzheimer disease. CERAD Clinical Investigators. Consortium to Establish a Registry for Alzheimer’s Disease. Alzheimer Disease and Associated Disorders, 9(2), 101–104. doi:10.1097/00002093199509020-00007 PMID:7662321 Melrose, R. J., Ettenhofer, M. L., Harwood, D., Achamallah, N., Campa, O., Mandelkern, M., & Sultzer, D. L. (2011). Cerebral metabolism, cognition, and functional abilities in Alzheimer disease. Journal of Geriatric Psychiatry and Neurology, 24(3), 127–134. doi:10.1177/0891988711405333 PMID:21856969 Melrose, R. J., Harwood, D., Khoo, T., Mandelkern, M., & Sultzer, D. L. (2013). Association between cerebral metabolism and Rey-Osterrieth Complex Figure Test performance in Alzheimer’s disease. Journal of Clinical and Experimental Neuropsychology, 35(3), 246–258. doi:10.1080/13803395.2012 .763113 PMID:23387510 Moschetti, K., Barragan, N., Basurto-Davila, R., Cummings, P. L., Sorvillo, F., & Kuo, T. (2014). Mortality and productivity losses from Alzheimer disease among US adults aged 40 to 64 years, 1999 to 2010. Alzheimer Disease and Associated Disorders. doi:10.1097/WAD.0000000000000017 PMID:24445567 Mungas, D., Jagust, W. J., Reed, B. R., Kramer, J. H., Weiner, M. W., Schuff, N., & ... (2001). MRI predictors of cognition in subcortical ischemic vascular disease and Alzheimer’s disease. Neurology, 57(12), 2229–2235. doi:10.1212/WNL.57.12.2229 PMID:11756602 Okonkwo, O. C., Griffith, H. R., Vance, D. E., Marson, D. C., Ball, K. K., & Wadley, V. G. (2009). Awareness of functional difficulties in mild cognitive impairment: A multidomain assessment approach. Journal of the American Geriatrics Society, 57(6), 978–984. doi:10.1111/j.1532-5415.2009.02261.x PMID:19467146 Palmer, K., Di Iulio, F., Varsi, A. E., Gianni, W., Sancesario, G., Caltagirone, C., & Spalletta, G. (2010). Neuropsychiatric predictors of progression from amnestic-mild cognitive impairment to Alzheimer’s disease: The role of depression and apathy. Journal of Alzheimer’s Disease, 20, 175–183. doi:10.3233/ JAD-2010-1352 PMID:20164594

10

 The Impact of Decline on Everyday Life in Alzheimer’s Disease

Pereira, F. S., Yassuda, M. S., Oliveira, A. M., & Forlenza, O. V. (2008). Executive dysfunction correlates with impaired functional status in older adults with varying degrees of cognitive impairment. International Psychogeriatrics, 20(06), 1104–1115. doi:10.1017/S1041610208007631 PMID:18752698 Perri, R., Monaco, M., Fadda, L., Caltagirone, C., & Carlesimo, G. A. (2014). Neuropsychological correlates of behavioral symptoms in Alzheimer’s disease, frontal variant of frontotemporal, subcortical vascular, and lewy body dementias: A comparative study. Journal of Alzheimer’s Disease, 39, 669–677. doi:10.3233/JAD-131337 PMID:24254701 Purser, J. L., Fillenbaum, G. G., Pieper, C. F., & Wallace, R. B. (2005). Mild cognitive impairment and 10-year trajectories of disability in the Iowa Established Populations for Epidemiologic Studies of the Elderly cohort. Journal of the American Geriatrics Society, 53(11), 1966–1972. doi:10.1111/j.15325415.2005.53566.x PMID:16274380 Rabinovici, G. D., Seeley, W. W., Kim, E. J., Gorno-Tempini, M. L., Rascovsky, K., Pagliaro, T. A., & ... (2007). Distinct MRI atrophy patterns in autopsy-proven Alzheimer’s disease and frontotemporal lobar degeneration. American Journal of Alzheimer’s Disease and Other Dementias, 22(6), 474–488. doi:10.1177/1533317507308779 PMID:18166607 Rog, L. A., Park, L. Q., Harvey, D. J., Huang, C. J., Mackin, S., & Farias, S. T. (2014). The independent contributions of cognitive impairment and neuropsychiatric symptoms to everyday function in older adults. The Clinical Neuropsychologist, 28(2), 215–236. doi:10.1080/13854046.2013.876101 PMID:24502686 Sadak, T. I., Katon, J., Beck, C., Cochrane, B. B., & Borson, S. (2014). Key neuropsychiatric symptoms in common dementias: Prevalence and implications for caregivers, clinicians, and health systems. Research in Gerontological Nursing, 7(1), 44–52. doi:10.3928/19404921-20130918-01 PMID:24079749 Schulz, R., & Beach, S. R. (1999). Caregiving as a risk factor for mortality: The Caregiver Health Effects Study. Journal of the American Medical Association, 282(23), 2215–2219. doi:10.1001/jama.282.23.2215 PMID:10605972 Severson, M. A., Smith, G. E., Tangalos, E. G., Petersen, R. C., Kokmen, E., & Ivnik, R. (1994). Patterns and predictors of institutionalization in community-based dementia patients. Journal of the American Geriatrics Society, 42(2), 181–185. doi:10.1111/j.1532-5415.1994.tb04949.x PMID:8126333 Sibener, L., Zaganjor, I., Snyder, H. M., Bain, L. J., Egge, R., & Carrillo, M. C. (2014). Alzheimer’s Disease prevalence, costs, and prevention for military personnel and veterans. Alzheimer’s & Dementia, 10(3) [Supplement], S105–S110. doi:10.1016/j.jalz.2014.04.011 PMID:24924663 Starkstein, S. E., Jorge, R., Mizrahi, R., Adrian, J., & Robinson, R. G. (2007). Insight and danger in Alzheimer’s disease. European Journal of Neurology, 14(4), 455–460. doi:10.1111/j.1468-1331.2007.01745.x PMID:17388998 Stout, J. C., Wyman, M. F., Johnson, S. A., Peavy, G. M., & Salmon, D. P. (2003). Frontal behavioral syndromes and functional status in probable Alzheimer disease. The American Journal of Geriatric Psychiatry, 11(6), 683–686. doi:10.1176/appi.ajgp.11.6.683 PMID:14609810

11

 The Impact of Decline on Everyday Life in Alzheimer’s Disease

Toro, P., Degen, C., Pierer, M., Gustafson, D., Schroder, J., & Schonknecht, P. (2014). Cholesterol in mild cognitive impairment and Alzheimer’s disease in a birth cohort over 14 years. European Archives of Psychiatry and Clinical Neuroscience, 264(6), 485–492. doi:10.100700406-013-0468-2 PMID:24241689 Vreugdenhil, A., Cannell, J., Davies, A., & Razay, G. (2012). A community-based exercise programme to improve functional ability in people with Alzheimer’s disease: A randomized controlled trial. Scandinavian Journal of Caring Sciences, 26(1), 12–19. doi:10.1111/j.1471-6712.2011.00895.x PMID:21564154 Winblad, B., Gauthier, S., Astrom, D., & Stender, K. (2010). Memantine benefits functional abilities in moderate to severe Alzheimer’s disease. The Journal of Nutrition, Health & Aging, 14(9), 770–774. doi:10.100712603-010-0122-x PMID:21085908

KEY TERMS AND DEFINITIONS Activities of Daily Living (ADLs): Universal skills necessary to independently care for oneself. ADLs are categorized as basic activities (e.g., grooming, bathing, and feeding) or more complex, instrumental activities (e.g., using transportation, managing finances, and keeping appointments). ADL scales are used to assess the degree of impairment in individuals with Alzheimer’s disease. Alzheimer’s Disease (AD): A progressive, neurodegenerative disorder which involves the deterioration of the medial temporal structures of the brain. AD is characterized by impairments in an individual’s ability to learn and remember new information, and leads to progressive cognitive decline, social isolation, and loss of independence for the individual. Apathy: The reduction of goal-directed behavior reflective of neural dysfunction and deterioration of the brain structures that control goal-directed behavior. Apathy is a common early feature of Alzheimer’s disease and has implications for functioning in social and occupational settings. Cognition: The internal mental process by which the brain communicates thoughts and emotions and executes behavior. Thought processes affected by the progressive deterioration of the brain in Alzheimer’s disease include memory, attention, decision-making, planning, visuo-spatial abilities, language, and executive function. Cognitive constructs may be tested by behavioral methods. Dementia: The presence of impairments in memory and at least one other cognitive domain that interfere with daily function. Dementia is a syndrome, and the term does not necessarily imply the presence of a neurodegenerative condition. Independence: The mental and physical capacity to execute everyday tasks and freely care for oneself with limited assistance. Loss of independence is a common outcome of Alzheimer’s disease and can negatively impact self-esteem, social relationships, and other aspects of everyday functioning. Mild Cognitive Impairment (MCI): Mildly decreased cognitive functioning that is considered an intermediate stage between normal aging and dementia. MCI includes objective and subjective observation of decreased functioning in memory and/or other cognitive abilities with relatively subtle changes in some higher level functional abilities. It is different from dementia, because those with MCI maintain independence in basic everyday living skills.

12

 The Impact of Decline on Everyday Life in Alzheimer’s Disease

Self-Efficacy: A belief in one’s ability to exert control over one’s behavior and motivation in order to attain specific goals. Self-efficacy is often substantially diminished in individuals with Alzheimer’s disease.

This research was previously published in Psychosocial Studies of the Individual’s Changing Perspectives in Alzheimer’s Disease edited by Cordula Dick-Muehlke, Ruobing Li, and Myron Orleans, pages 327-338, copyright year 2015 by Medical Information Science Reference (an imprint of IGI Global).

13

14

Chapter 2

Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support Leontios J. Hadjileontiadis Aristotle University of Thessaloniki, Greece Dimitrios Mandiliotis Aristotle University of Thessaloniki, Greece Konstantinos Toumpas Aristotle University of Thessaloniki, Greece Aikaterini Kyprioti Aristotle University of Thessaloniki, Greece

ABSTRACT Alzheimer’s Disease (AD), being the most common form of dementia diagnosed in people over 65 years of age, is a global problem with dramatic impact, as there is no cure for it and worsens as it progresses, eventually leading to death. As the sufferer declines s/he often withdraws from family and society, leading to a marginalized way of living. Considering the life expectancy rise, a looming global epidemic of AD is foreseen; hence, new approaches need to be considered regarding AD prevention, diagnosis, treatment, and confrontation. In this vein, an alternative approach (namely Symbiosis) towards a symbiotic Human-Computer Interaction (HCI) environment is presented in this chapter, as a means to facilitate, understand and incorporate the needs of the whole AD community (i.e., patients, caregivers and doctors), involving cutting-edge technology, special serious games and natural-user interfacing, embedded within an innovative design framework. Overall, Symbiosis acts as a technology-based mediator for AD’s indoor and outdoor activities, fostering their social inclusion and increasing their quality of life in a symbiotic context.

DOI: 10.4018/978-1-5225-7122-3.ch002

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

INTRODUCTION Efficient Human-Computer Interaction (HCI) (Card et al., 1980), when applied to the field of assistive technology for special groups of people (e.g., patients, disabled, elderly), can significantly contribute to the elevation of their quality of life, as it could act as a facilitator for the maximization of the assistance provided by the system to humans in a more natural way. Although the user interface is the primary element between a user and the computer, HCI is a larger discipline that deals not only with the design of the screens and menus, but also with the reasoning for building the functionality into the system in the first place. It is also considers the consequences of using the system over time and its effects on the individual, group and company. Even from the advent of the first computers (Abascal, 2002), there has been established a set of commonly accepted stereotypes and expectations about materialization of HCI through intelligent machines and robots that are able to fulfil the ‘human gap’. Although nowadays, many of these wishes and predictions have reached a degree of reality (mainly in the context of performing many difficult tasks better, quicker and more accurately than humans can or producing new fields of their activities that render the HCI involvement a necessity), HCI maximizes its beneficial intervention when disability comes into foreground. The evolutionary trajectory of shifting from the massive computer-machine to a personal one, reaching the era of mobility with smartphones and tablets, has been influenced by technological, commercial and social parameters, followed, simultaneously, by the fight against social exclusions and discrimination, the people with disabilities were involved in. The conjunction of the technological evolution with the struggle of people with disabilities for autonomous and socially integrated life, set the horizon of new technological challenges and new research and marketing endeavors. A basic novelty of HCI is the clear separation of the application level from the interface level, that plays a crucial role when HCI users have disabilities since a wide range of interfaces could be used for the same application (depending on the user’s needs and abilities). In addition, the same interface could be used to gain access to different applications, avoiding unnecessary and/or confusing interface modifications. Intelligent-, adaptive-, affective mediation-, natural user-, and pervasive-interfaces involved in the HCI realization set a diversity of available interface choices to the users, especially to those with disabilities, as the former are well adapted to the latter’s’ specifications and needs. With the intention to make accessible commercial equipment, the ‘Universal Design’ (UD) (also called ‘Design for All (DfA)’) design orientation was developed aiming to produce systems that are designed to be used by everyone, independently from the physical or cognitive skills. Pragmatically, this is almost impossible bearing in mind the diversity of the users’ features, at least in the design phase, but it is possible to avoid unnecessary barriers to the accessibility that are frequently added. To this end, UD adopts the basic principles of: a) equitable use, b) flexibility in use, c) simple and intuitive, d) perceptible information, e) error tolerance, f) low physical effort, g) size and space for approach and use. In fact, UD enhances the usability of the product and is also extremely beneficial for non-disabled people when using the specific system under special conditions (Abascal, 2002). DfA in the context of information and communications technology (ICT) is the conscious and systematic effort to proactively apply principles, methods and tools to promote UD in computer-related technologies, including Internet-based technologies, thus avoiding the need for a posteriori adaptations, or specialized design (Stephanidis, 2001; ETSI EG 202 116 V1.2.1 (2002-09)). Nevertheless, UD is not a panacea; as a liturgical beneficial combination for people with disabilities, UD should be combined

15

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

with assistive technology, as it is clear that both are necessary and complementary (Abascal & Civit, 2001). One fundamental issue in this cooperative design of HCI interfaces for disabled is the role of the user him/herself. Clearly, the opinions and beliefs of users, their representatives and rehabilitation staff upon their real needs and interface expectations are vital. In addition, testing procedures involving users must be defined to ensure that developments are suited to their needs. With the evolution of HCI (adopting UD), computer and human will not remain separate entities but will confluent into a symbiotic cooperation (Boff, 2006). As the definition of the word ‘symbiosis’ states, two equal entities will work together and fulfill their goals with mutual advantages. Fusing both entities will result in an improved ability to handle disturbances and unexpected events, and therefore increase performance and resilience. Cooperation in this symbiotic entity is intended to be model-based, both for human (using information, such as his/her state, general performance, preferences and capacities, emotions, engagement, frustration, surprise, intention, and boredom), computer (using technical information such as layout, dialogues, software applications and dependencies), task (containing information on the task demands that affect human operator performance and effort), and context (using high level information of the environment, such as information about the importance of tasks, the hierarchy of events and organizational context). It is no longer just automation of routines and re-allocating tasks to the user or the system, but a knowledge-based relation that optimizes interaction. Moreover, both the user and the system are proactive, based on new knowledge that is constantly updated by active learning processes in case of uncertainty (Grootjen et al., 2010). Nevertheless, human and system are equal partners, but not similar, so both will have their own constraints and requirements, especially for the case of people with disabilities. With the aforementioned in mind, the main objective of this chapter is to present an HCI-based symbiotic environment for Alzheimer’s support, namely ‘Symbiosis’1. The specific characteristics of the latter, both from the perspective of the users’ needs and the system’s architecture, implementation and functionality, are explored and thoroughly described. Moreover, issues reflecting Symbiosis’ personalized support to patients with Alzheimer’s Disease (AD) regarding their quality of life and social inclusion, along with care-givers and attending physicians for facilitating and alleviating their workload and emotional burden are pointed out. To achieve this, the necessary background is provided in the succeeding section.

BACKGROUND Alzheimer’s Characteristics and Consequences AD was first described by the German psychiatrist and neuropathologist Alois Alzheimer in 1906 and was named after him. Most often, Alzheimer is diagnosed in people over 65 years of age, although the less prevalent early-onset. As the disease advances, symptoms can include confusion, irritability and aggression, mood swings, trouble with language, and long-term memory loss. As the sufferer declines he often withdraws from family and society. Gradually, body functions are lost, ultimately leading to death. Since the disease is different for each individual, predicting how it will affect the person is difficult. Alzheimer develops for an unknown and variable amount of time before becoming fully apparent, and it can progress undiagnosed for years. On average, the life expectancy following diagnosis is ap-

16

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

proximately seven years. The cause and progression of AD are not well understood. Research indicates that the disease is associated with plaques and tangles in the brain. Current treatments only help with the symptoms of the disease; they cannot stop or reverse its progression. AD is divided into three rough stages with progressive patterns, i.e.: 1. The preclinical stage with no symptoms (45-55 yrs) 2. The mild cognitive impairment (MCI) with mild mental symptoms (55-70 yrs), and 3. The severe fatal stage of the disease (>70 yrs). Apparently, technology can contribute significantly to the problem of Alzheimer’s by offering solutions mainly at the MCI stage of the disease. The most significant skills affected at this stage of the disease are: memory, attention, orientation, visual perception and space perception. In a more refined approach, Barry Reisberg, M.D. (clinical director of the New York University School of Medicine’s Silberstein Aging and Dementia Research Center), defines a seven-stage framework with the following symptoms (Alzheimer’s Association, 2007): 1. No Impairment (Normal Function): The person does not experience any memory problems. An interview with a medical professional does not show any evidence of symptoms of dementia. 2. Very Mild Cognitive Decline (May Be Normal Age-Related Changes or Earliest Signs of Alzheimer’s Disease): The person may feel as if he or she is having memory lapses, i.e., forgetting familiar words or the location of everyday objects, but no symptoms of dementia can be detected during a medical examination or by friends, family or co-workers. 3. Mild Cognitive Decline (Early-Stage Alzheimer’s Can Be Diagnosed in Some, But Not All, Individuals With These Symptoms): Friends, family or co-workers begin to notice difficulties. During a detailed medical interview, doctors may be able to detect problems in memory or concentration. Common stage 3 difficulties include: a. Noticeable problems coming up with the right word or name; b. Trouble remembering names when introduced to new people; c. Having noticeably greater difficulty performing tasks in social or work settings, forgetting material that one has just read; d. Losing or misplacing a valuable object; and e. Increasing trouble with planning or organizing. 4. Moderate Cognitive Decline (Mild or Early-Stage Alzheimer’s Disease): At this point, a careful medical interview should be able to detect clear-cut symptoms in several areas: a. Forgetfulness of recent events; b. Impaired ability to perform challenging mental arithmetic — for example, counting backward from 100 by 7s; c. Greater difficulty performing complex tasks, such as planning dinner for guests, paying bills or managing finances; d. Forgetfulness about one’s own personal history; and e. Becoming moody or withdrawn, especially in socially or mentally challenging situations. 5. Moderately Severe Cognitive Decline (Moderate or Mid-Stage AD): Here, gaps in memory and thinking are noticeable, and individuals begin to need help with day-to-day activities. At this stage, those with Alzheimer’s may: 17

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

a. Be unable to recall their own address or telephone number or the high school or college from which they graduated; b. Become confused about where they are or what day it is; c. Have trouble with less challenging mental arithmetic; such as counting backward from 40 by subtracting 4s or from 20 by 2s; d. Need help choosing proper clothing for the season or the occasion; e. Still remember significant details about themselves and their family; and f. Still require no assistance with eating or using the toilet. 6. Severe Cognitive Decline (Moderately Severe or Mid-Stage AD): At this point, memory continues to worsen, personality changes may take place and individuals need extensive help with daily activities. At this stage, individuals may: a. Lose awareness of recent experiences as well as of their surroundings; b. Remember their own name but have difficulty with their personal history; c. Distinguish familiar and unfamiliar faces but have trouble remembering the name of a spouse or caregiver; d. Need help dressing properly and may, without supervision, make mistakes such as putting pajamas over daytime clothes or shoes on the wrong feet; e. Experience major changes in sleep patterns-sleeping during the day and becoming restless at night; f. Need help handling details of toileting (for example, flushing the toilet, wiping or disposing of tissue properly); g. Have increasingly frequent trouble controlling their bladder or bowels; h. Experience major personality and behavioral changes, including suspiciousness and delusions (such as believing that their caregiver is an impostor) or compulsive, repetitive behavior like hand-wringing or tissue shredding; and i. Tend to wander or become lost. 7. Very Severe Cognitive Decline (Severe or Late-Stage Alzheimer’s Disease): In the final stage of AD, individuals lose the ability to respond to their environment to carry on a conversation and, eventually, control movement. They may still say words or phrases. At this stage, individuals need help with much of their daily personal care, including eating or using the toilet. They may also lose the ability to smile, sit without support and hold their heads up; reflexes become abnormal; muscles grow rigid; swallowing impaired. AD is also known for placing a great burden on caregivers. Caring for someone with AD impacts every aspect of daily life. As Alzheimer’s patients lose one ability after another, caregivers face pressures wide-ranging from social and psychological to physical elements of the caregiver’s life (Thompson et al., 2007). Moreover, AD is one of the most costly diseases worldwide (Meek et al., 1998; Brookmeyer et al. 2007) as worldwide cost of dementia is estimated to have been US$ 604 billion in 2010 (Alzheimer’s Disease International (ADI) and World Health Organization (WHO) 2012 report). As the world population ages, we truly face a looming global epidemic of AD, considering that nowadays, every 68 seconds a new AD patient appears. Epidemiological studies indicate that numbers of ADs will nearly double every 20 years, to 65.7 million in 2030 and 115.4 million in 2050, affecting 1 in 85 people globally (Förstl & Kurz, 1999).

18

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

The cost of AD is covered by three main sources, i.e.: a) the informal, which includes the costs that usually cumber the family, b) the medical, concerning the financial burden borne by the insurance funds, and c) the social, including costs available from the state and institutions of social responsibility. The cost seems to be allocated differently to these three sources, depending on the income of each social group (see Figure 1), and, thus, the existence of a flexible solution, covering the main pillars of the Alzheimer’s community (patients, caregivers, physicians) seems to be particularly beneficial for all. Moreover, as in a long-term, it is expected for countries with middle and low incomes to be more affected by the disease (see Figure 2), the need for economic solutions is imperative. Figure 1. The costs per person with dementia in different World Bank income groups (in US$) (adapted from http://www.alz.co.uk/research/statistics).

Figure 2. The number of people with dementia in low and middle income countries compared to high income ones (adapted from http://www.alz.co.uk/research/statistics).

19

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

Clinical Standards and Technological Approaches In clinical practice or in clinical trials several robust standardized tools are employed. The most commonly used are (Robert et al., 2013): 1. The Mini Mental Score Examination (MMSE) for cognitive global assessment; 2. The Alzheimer Disease Assessment Scale (ADAS) to measure the severity changes of the most important cognitive symptoms; 3. The Neuropsychiatric Inventory (NPI) interview for Behavioral and psychological symptoms; and 4. The Clinical Dementia Rating (CDR) to quantify the severity of symptoms of Dementia. Nevertheless, clinical assessments through questionnaires, scales or observations risk bias resulting from the assessor’s subjectivity or the usually interviewed caregiver. Furthermore, test results can show variability depending on many factors such as emotional state, and may, therefore, not always fully reflect a patient’s capacities and the complexity of the disease, which can lead to delayed diagnosis (Sampaio, 2007). As a consequence, over the last decade, research has focused on the development and use of various sensors to monitor activities of the elderly as well as of AD patients. These include cameras and microphones for activity recognition (Clarkson et al., 1998) embedded sensors (Wang et al., 2007) or sensors placed on the body (Foerster & Fahrenberg, 2005). A thorough list of ICT use in elderly subjects and patients with AD and related disorders, focusing on patient’s behavior, incorporating technologies such as actigraphy (monitoring human rest/activity cycles), infrared-sensors, computerized video analyses, tracking technologies, smart home infrastructure, can be found in the recommendations of Robert et al. (2013). In general, special attention should be given to ICT solutions that provide personalized information and more objective assessment that indirectly help people with AD and their caregivers to better understand behavioral and psychological symptoms of dementia and provide help with their daily living activities (Lauriks, 2007). Until now, all technological solutions addressing Alzheimer’s with alternative (non-pharmaceutical) approaches focus on the satisfaction of a specific need, e.g., position tracking (e.g., GPS Shoe, http://www.gpsshoe.com/), memory and skill enhancement (e.g., Lumosity Brain Games, http://www.lumosity.com/sdsd) and daily needs reminder (e.g., e-pill Medication Reminders, http:// www.epill.com). Nevertheless, as the disease progresses, the patient cannot successfully interact with his/her environment, as the terms that define it become obscure. To this end, a more holistic tactic is needed, such as the Symbiosis framework proposed here. The structural characteristics and functionality of Symbiosis is described in detail in the subsequent section.

THE PROPOSED ‘SYMBIOSIS’ FRAMEWORK Meeting the Needs-Setting the Goals Symbiosis is a revolutionary system aiming at providing integrated solutions to a series of problems related with AD. Using cutting-edge technology, it provides a holistic approach to the problem, combining all the distinct solutions and introducing a novel HCI strategy that provides a Natural User Interface (NUI) and offers both physical and mental exercise. Symbiosis takes into account the patient’s response 20

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

in an adaptive way that fulfills each patient’s special needs and normalizes the demands of the environment to his/her abilities. It also provides considerable facilitations to caregivers and doctors, providing real-time patient’s location and status monitoring, psychological support, symbiotic interaction activities and efficient progress monitoring (at any time/from anywhere) and scheduling, unlocking the potential of an innovative supporting role. Overall, the Symbiosis goals are: 1. Establishment of a novel, holistic approach to the special needs imposed by Alzheimer’s disease, offering services and tools at three different groups involved in the problem, i.e., patients; caregivers; and doctors. 2. Personalization to each patient’s specific characteristics through system adaptation and self-regulation procedures. 3. Development of adapted user’s scenarios following the patient’s profile and schedule. 4. Assistance to caregiver for preparation, customization and optimization of patients’ care and monitoring procedure through a continuous update about their progress via well-managed Web Services. 5. Doctors’ updating via reporting material with statistical analysis options. 6. Emphasis on patient’s autonomy from caregiver. 7. Alleviation of negative feelings and contribution to the sustenance of quality of life in an environment that promotes the real concept of Symbiosis.

Design Architecture As it was already mentioned, the ICT-based intervention could maximize its effect at the MCI stage of the AD, targeting the significant skills that are affected at this stage (i.e., memory, attention, orientation, visual perception and space perception). Based on this fact, and taking into account design considerations, such as customization, extensibility and user-friendly interfacing, the design architecture of Symbiosis is developed in a modular fashion, consisting of three modules with diverse functionalities, i.e., the patient module (P); the caregiver module (C); and the doctor module (D). All three modules are interconnected and exchange information through Microsoft Cloud Platform Azure (http://www.windowsazure.com/ en-us/develop/overview/), supporting in this way the idea of a real Symbiosis (see Figure 3). Analytical description of the functionality of each module follows.

Modules Description The aforementioned modular architecture is reflected into the main user-interface of Symbiosis, which is depicted in Figure 4. From there, the patient’s, caregiver’s and doctor’s modules are corresponded to tile-columns, each one consisting of different functionalities per user.

Patient’s Module The patient’s module includes a series of applications available to the user. The core concept of HCI within Symbiosis is the maximization of the flexibility of user interaction with the system. To this end, Symbiosis proposes a fruitful way of NUI for the patient, through state-of-the-art technologies, such as augmented reality (AR) scenarios, body motion tracking and EEG signal processing. All activities from 21

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

Figure 3. The modular architecture of Symbiosis targeting the three pillars of patient (P), caregiver (C) and doctor (D), existing within a symbiotic space.

Figure 4. The modular architecture of Symbiosis targeting the three pillars of patient (P), caregiver (C) and doctor (D), existing within a symbiotic space.

games to AR scenarios are designed and developed to meet the special needs of an AD patient, with special emphasis given on the elimination of social exclusion. Mental and physical exercising, a sense of autonomy and increased self-confidence are the primary targets of all applications along with adaptation to personalized behavior, preferences and needs. In this way, the patient’s environment is normalized to his/her needs and not vice versa. In particular, descriptions of the patient’s Symbio-modules (see Figure 3-the P branch) are given below:

22

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

1. SymbioGames: It is a gaming suite that offers a wide range of games aiming at exercising and improving skills, such as memory, attention, orientation, visual and space perception that gradually decline at the MCI stage of the disease. Furthermore, the novel NUI strategy using Kinect sensor (Gonzalez, 2010), provides a NUI that introduces the idea of combined physical and mental exercise. For example: a. BirdHunt. In this game, the AD patient undertakes the task to ‘catch’ the birds that appear on the screen. The position of the bird on the screen is defined according to the physiotherapy scenario of the specific patient, regarding his mobility. Hence, as the game proceeds, both hands are involved with two birds simultaneously appearing on the screen and their position follows the doctor’s schedule for hand movement e.g., 10 times up-down/down-up, 15 times left-to-right/right-to-left, etc. The reward offered to the patient, when succeeding, is the gradual revelation of a puzzle-like photo from his/her past. When three levels of the game are successfully achieved, the user is asked to arrange in a chronological order (in a time-line from left (past) to right (present)) the three revealed photos. In this way, both mental and physical abilities of the patient are activated. It is noteworthy that the whole interaction with the game is realized via the NUI of Kinect (see Figure 5). Figure 5. The screen of BirdHunt (top) with the appearance of the bird and the hand position (like a viewfinder) along with the NUI interaction via Kinect (bottom).

23

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

b. MemoryShapes. In this game, the AD patient is asked to memorize a series of shapes/colors and to understand if a random new series of shapes absolutely coincides with the one just previously previewed. The user’s selection is realized through Kinect and the reward-target in this case, is, through successful responses, the patient to keep a face (icon) smiling and not neutral or sad (see Figure 6). In this way, the mental and physical exercises are accompanied by a face expression identification capability, targeting positive feelings. c. SymbioFriends. In this game, the patient is asked to match via Kinect photos of faces to names (see Figure 7). The previewed photos are drawn from his/her Facebook automatically or selected manually by the caregiver using the corresponding editing interface. Here, among others, the emotional part is targeted, so the patient could recall emotions linked to the specific photos (faces) and names of his/her friends, accordingly. d. TurnTable. In this game, the patient is recollecting his past by listening to music of his/her era (displayed each time as a collection of three long-play (LPs) disks to select for the turntable using Kinect), with a huge selection of music pieces from the charts between 1900-2000 (see Figure 8). After listening to the music from the three LPs, the patient is asked to arrange them (using Kinect) in the correct chronological order (in a time-line from left (past) to right (present)), activating, amongst others, his memory abilities. Figure 6. The screen of MemoryShapes (top) with the appearance of the shape/colors and the hand position (like a pointing finger) along with the NUI interaction via Kinect (bottom).

24

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

Figure 7. The screen of SymbioFriends (top) with the appearance of the photos with faces and names and the hand position (like a pointing finger) along with the NUI interaction via Kinect (bottom).

Figure 8. The screen of TurnTable with the appearance of the available LPs and the turntable and the positions for chronological arrangement (using Kinect) of the three LPs, from 1900 towards 2000.

25

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

e. SymbioPuzzle. In this game, from the patient’s photo album a photo with recollection content of the past is selected (automatically by the patient’s e-photo album or manually by the caregiver via the corresponding editing tool) and turned to a puzzle for a tablet (see Figure 9) and/or a PC with touch-screen. In this way, the user uses his finger to move the pieces and put them in the correct position, trying to reveal the photo, motivated by its content. In this way, his mental and memory abilities are further activated. f. SymbioMusic. Music has power—especially for individuals with AD and related dementias, and it can spark compelling outcomes even in the very late stages of the disease. When used appropriately, music can shift mood, manage stress-induced agitation, stimulate positive interactions, facilitate cognitive function, and coordinate motor movements. In this vein, SymbioMusic is a multiplayer game, where the AD patient along with, for example, a friend, the caregiver, a relative, can collaboratively produce percussive sounds and rhythms, just by moving their hands and feet. The NUI of Kinect recognizes the location of the users’ body, feet and hand gestures and activates the corresponding percussive sounds (via MAX/MSP interfacing). In this way, the patient feels, in an experiential way, the music, producing it with his/her movements and, at the same time, s/he has the chance to collaborate in this creative experience and share it with his/her peer (see scenarios in Figure 10). Naturally, the instrument set-up could be arranged in many different ways to increase users’ engagement in a long-term use of music therapy scenarios. 2. SymbioEyes: By incorporating automatic photo shooting, GPS tracking, activity reminder, emergency/fall detection and call, SymbioEyes is the all-in-one patient mobile application (see Figure 11-left). The patient, in case s/he feels lost, just touches the smartphone screen for two seconds and an alarm is activated to the caregiver (receiving in his/her smart phone/tablet an emitted sound-alarm, the patient’s location GPS co-ordinates, displayed position on the map (see Figure Figure 9. The tablet screen of SymbioPuzzle, where a photo from the patient’s photo album is turned to a puzzle.

26

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

Figure 10. Two different scenarios of using SymbioMusic for collaborative percussive sound production.

Figure 11. SymbioEyes monitoring patient’s outdoors location and status (left), while the information is transmitted real-time to the caregiver’s smartphone (right). In this case, the AD patient does not feel well and touches the smartphone surface (left), so the alarm has been activated and his status has been changed to ‘Emergency’ to the caregiver’s site (right).

11-right), timestamp and a photo of the incident), while, at the same time, the patient is provided with audio guidance to calm and that help is on the way. In this approach, the AD patient feels more autonomous and safe to be mobilized outdoors, increasing his social interaction, while, the caregiver, by monitoring in real-time the position and status of the AD patient, feels less stressed of losing out his/her patient. 3. Re-Biosis: This application automatically downloads from the Microsoft Cloud all photos taken by SymbioEyes application and creates slideshows. While these slideshows are presented to the patient at home, the photos are subjected to an emotional tagging procedure stemming from EEG signals processing that takes place in the background. The EEG signals are acquired through Emotiv EPOC headset (www.emotiv.com) (Figure 12-left), which is a light ware, Bluetooth 14-channels EEG acquisition device. At the bottom of the Figure 12-right, a sample of the acquired EEG signal

27

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

Figure 12. Re-biosis captures the emotions of routing photos via EEG recording (left) and uses the positively tagged ones (smiling icon-face on the right) for re-biosis of the causality of the routing (displayed on a map on the right), for efficient memory enhancement.

is displayed and an asymmetry meter (in an analog form) regarding the current activation of the left or the right brain hemisphere. As Davidson (1995) points out, the left hemisphere is dominant for processing positive emotions whereas the right hemisphere is dominant for processing negative emotions. In this way, it is feasible to understand the positive or negative impression of the photo to the AD patient. Moreover, there is a map display with the routing corresponding to the tagged pictures, in order to facilitate the spatial correspondence and memory recall of the environment during the routing. The re-biosis process is repeated after some days, yet without the acquisition of the EEG, so only the emotionally tagged pictures (positive impact) are previewed, along with the route on a map with some blank spaces. There, the AD patient has to place the correct photo from the available ones, recreating the route sequence in his/her brain. In this way, s/he reinforces the causal relationships between the pictures related to their sequence in the route, strengthening, at the same time, his memory ability about why s/he performed this routing and what s/he has experienced during the latter. 4. SymbioSpace: This application involves AR technology and through its audiovisual information that provides to the AD patients facilitates his/her everyday life. Using a simple AR tag to an object instead of the common stickers, the information about what it is and how it is used is projected through AR glasses. For example, in Figure 13, the shifting from stickers to AR use for the way a soup is eaten is shown. The concept of AR glasses is very familiar to the necessity and habit of the elderly to simple wear glasses. The AR glasses used now are from AR Vusix and they could also incorporate different settings for myopia and presbyopia; in the near future, Google Glasses could also be incorporated. With AR glasses, an additional information is superimposed upon the reality previewing, assisting the user to better comprehend the objects’ use in his/her environment. Moreover, the functionality of SymbioSpace is further extended to foster the symbiotic relationships between the elderly and the younger members of the family. For example, as one of the common roles of the grandparents is to narrate fairytales to their grandchildren, a simple AR tag beside an image that accompanies the fairytale text could facilitate the narration by providing a text simpli-

28

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

Figure 13. The shifting from stickers (top row) to SymbioSpace functionality using AR glasses for audiovisually explaining to the AD patient about the correct use of spoon for eating the soup instead of a knife (bottom row); note that the AR tagging (SPUN) is set in the napkin, besides the plate.

fication to him/her (see Figure 14). In addition, simple AR tags could be created by the caregiver or a member of the family (using the dedicated editing tool of Symbiosis) to map them to photos and videos from the past, related to a specific member of the family and/or a friend, uploaded to his/her mobile phone. Through SymbioSpace, and by placing the mobile phone (with the AR tag previewed on its screen, just like the AR tag in the napkin in Figure 13) between the AD patient and the family member or the visiting friend, the AD patient is provided, through the AR glasses, with additional audiovisual information that activates his/her long last memory, so s/he could easily understand who the person that stands opposite and talks to him/her is. In this way, the AD patient, like the case of NUI-based SymbioGames, could enhance his/her participation into the everyday life of the family, socialize with his/her friends providing him/her with more self-confidence and the sense of usefulness, extending the quality of the symbiotic space amongst all members of the family and/or friends’ community.

Caregiver’s Module Caregiver’s every-day life is being supported by the Symbiosis-based local and distant monitoring of the AD patient’s behavior, offering emergency notifications and valuable feedback-information that helps schedule his/her daily routine in a novel and efficient fashion. Emphasis is given in providing assistance to the caregiver for preparation, customization and optimization of the patients’ care and monitoring

29

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

Figure 14. The SymbioSpace functionality using AR glasses for text simplification of an extended text that corresponds to an image in a fairytale, so the grandparent could narrate it much easier to his grandchildren. The AR tag (TALE) is put under the extended text.

procedure through a continuous update about their progress via well-managed Web Services. In addition, Symbiosis can be used by the caregiver as a way to come even closer with the broader caregivers’ community by sharing and discussing related problems, and so his/her supporting role is transformed into a symbiotic one towards the increase of the AD patients’ quality of life. The caregiver’s Symbiomodules analytically include: 1. SymbioSchedule: Balancing the enormous task of care giving with other responsibilities requires diligent planning and organization. SymbioSchedule meets this requirement exactly, since it contains the activity program, related to the available interactions with the Symbiosis patient’s modules (e.g., SymbioGames), for the patient as it is scheduled by the doctor. 2. SymbioProgress: One of the main aspects of care giving is the need for constant monitoring. SymbioProgress constitutes the monitoring tool for the caregiver offering an effective overview of the patient’s progress, as it is depicted through statistics on patient’s interaction with Symbiosis applications (Figure 15). 3. SymbioOptions: To achieve personalization and customization of all Symbiosis applications, SymbioOptions provides a control panel where the caregiver can add audiovisual material (e.g., photos, videos, music, AR tags) and adjust the settings of patient’s applications. 4. SymbioCircle: Grief, depression and anger are common among caregivers making psychological support more than necessary. SymbioCircle is Symbiosis’ forum, where caregivers can find online advice and psychological support as well as exchange opinions with others (see Figure 16).

30

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

Figure 15. The SymbioProgress functionality for providing the statistics to the caregiver for patient’s progress in different dates.

Figure 16. The SymbioCircle forum for sharing and psychological supporting the caregivers.

31

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

Doctor’s Module Symbiosis enables the doctor to have daily detailed reporting material with statistical analysis options of every patient’s progress, compare the progress of many patients and easily categorize them. Furthermore, the doctor can remotely adjust each Symbiosis’ activity parameters according to each patient’s profile. Higher levels of functionality and work efficiency are achieved, as Symbiosis takes the computational burden of data analysis, providing all the necessary means for frequent monitoring of the AD patient’s health record. Hence, the doctor’s working attitude is reformed, as the information of the Symbiosis platform (based on the Microsoft Cloud secure repository) is available anytime and anywhere, setting the handling of care services on both local (patient’s site) and remote bases. The doctor’s Symbio-modules analytically include: 1. SymbioOverview: By using SymbioOverview the doctor can have a detailed and daily statistical overview of every patient’s progress, compare the progress of many patients and easily categorize them (Figure 17-top). Since each doctor has many patients, SymbioOverview enables the doctor to have detailed statistical overview of every patient’s progress in an easily organized and categorized way (Figure 17-bottom). Figure 17. The use of the SymbioOverview by the doctor for overall patients’ preview both from his/her smartphone and PC (top) and detailed statistical overview of each patient’s progress (bottom).

32

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

2. SymbioOrganizer: Using SymbioOrganizer, the doctor can adjust the Symbiosis activities/parameters according to each patient’s profile (Figure 18).

Technologies Involved The technologies involved in the realization of the Symbiosis framework include among others: • • • •

Cloud Computing: MS Azure Platform; Development Tools: Visual Studio 2012 Professional; Other Technologies: .NET Compact Framework 4.0, Windows Mobile 7.5, Windows 8.1 Business Edition, C#, XML Web Services, ASP.NET, Silverlight, Windows Presentation Foundation, Bing Maps 3D, Windows Communication Foundation, Expression Blend; and Hardware: MS Kinect, Emotiv EEG headset, AR glasses, Windows phone.

Testing A pilot testing of Symbiosis applications involving 20 MCI patients (ages 58-70) was conducted at both Alzheimer’s Care Centers of Thessaloniki, Greece. The metrics that were used include interaction engagement metrics pre- and post-using Symbiosis, involving: a) successful usages per day/month, b) duration of use, c) recency of use, d) frequency of mid-application quits. The preliminary results indicate that the use of Symbiosis helped the AD patients increase their spatial perception (mainly due to its NUI) and their interaction engagement (mainly due to the gaming and experiential way of interacting), assisting also with emotional engagement (due to the emotional tagging of images), mental efficiency (due to cognitive games and routing exercises), and memory sustain (due to causality enhancement of actions and relations). All participants expressed their satisfaction and fostered Symbiosis’ user-friendliness, showing Figure 18. With the use of SymbioOrganizer, the doctor can adjust the Symbiosis activities/parameters according to each patient’s profile.

33

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

increased interest in adopting it in their daily schedule. As a continuation of the testing, a pilot-study is scheduled in the near future, involving mobilization of young students (e.g., from the fields of electrical and computer engineering) under the ‘Adopt-an-Elderly’ movement. In the latter, after proper training, the young students could help the AD patients use the Symbiosis in their everyday life, simultaneously, providing useful feedback. In this way, merging of distant generations to the same interactive environment could be achieved and the symbiotic concept will be applied both at the HCI and the social context.

Enhanced Features: Mobility and BPM Feedback In an effort to increase the efficiency and ‘smartness’ of Symbiosis, some enhanced features have been considered and exploited from a research point of view. In particular, the concepts of estimated mobility and Beats-Per-Minute (BPM) have been targeted, in an effort to get some additional information of the AD patient’s physical status during his/her interaction with Symbiosis. This can, then, be used as an effective feedback to the system, so as to adjust, the difficulty and mobility level according to the user’s capacities (e.g., when BPM increases at a certain level due to tiredness or stress), during his/her interaction with Symbiosis (e.g., SymbioGames).

Estimated Mobility The mobility signal was estimated using the integration of Kinect motion data. One of the most important features that Kinect provides, is the skeleton extraction from all the users that are detected in the video frame. The skeleton extraction process basically returns the position of all the main joints of the human body, in a 3D space (see Figure 19-left). An example of a right-handed patient’s estimated right-hand joint changes, during his interaction with Symbiosis under the BirdHunt game and MemoryShapes is Figure 19. The skeleton joints extracted by the Kinect sensor (left) and the estimated mobility of the right hand joint of an AD patient when playing the BirdHunt (right-top) and the MemoryShapes (right-bottom).

34

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

shown in Figure 19-right. As it was expected, the mobility of the specific joint for the case of BirdHunt was significantly higher than the case of MemoryShapes, since the latter, unlike the BirdHunt, relates more to the mental activity rather than the physical (spatial) one. Using information like the one depicted in Figure 19-right from all the Kinect joints of Figure 19left, the total mobility signal can be estimated per each session and in a sequence of sessions. Based in this information, with proper statistical analysis a kind of ‘mobility interaction label’ of each patient could be extracted. The latter, then, could be used as an input to AD patient’s profile and contribute to the personalization of Symbiosis’ interaction, with the setting of relevant thresholds to produce a series of warnings and alarms, both to the caregiver and the doctor.

Estimated BPM In addition to the patient’s ‘mobility interaction label’, the estimation of the BPM could be used as a ‘biosignal dynamic index’ that projects upon the patient’s mobility style his/her physical status in a real-time mode. In this way, BPM fluctuation and levels could be considered as indices for alarm about the AD patient’s condition, taking into account his/her medical history. The BPM estimation was based on the frame analysis of the video captured by the Kinect camera, testing a series of advanced image analysis algorithms (Kyprioti & Toumpas, 2013). A characteristic example of the testing is given in Figure 20, where RGB channels analysis is employed, targeting the instantaneous frequency of the color fluctuations of the face area per channel due to the hemodynamic change (Kyprioti & Toumpas, 2013). Using the information of mobility and BPM, Symbiosis becomes ‘smarter’ from its use and develops a kind of protective behavior (e.g., slowing down the games, suggesting resting periods, etc.) to the AD patient.

Comparison to Other Approaches Placing the Symbiosis framework into the environment of existing approaches in the area, the following comparison axes could be identified: Figure 20. The estimation of the BPM of an AD patient when playing the SymbioGame BirdHunt via the analysis of the face color changes (Kyprioti & Toumpas, 2013).

35

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

1. Mobile phone applications or specific devices for GPS tracking of the patient, such as Navistargpsshoe (GPS-equipped shoe) and Locationnow (GPS-equipped bracelet), which however, do not provide any additional functionality, such as fall detection; 2. Photo capturing applications for memory enhancement, such as memeXercisor, based on a simple camera with no emotional tagging of the captured photos; 3. Audio-based reminders for reminding basic scheduled activities, like pill reminder such as the epill, which however, do not exhibit combined facilities; and 4. Web-based games for memory enhancement, such as Lumosity and BrainTivity yet not especially designed for dementia and AD patients, incorporating mouse interaction, do not combine body activity and they do not take into account any emotional stimulation. Two additional recent efforts in the area refer to the research project Long Lasting Memories (www. longlastingmemories.eu/) that incorporates Wii-based interfacing from Nintendo, targeting, however, mostly the pre-clinical phase and not the personalized approach of Symbiosis, and to the application Alzminder (or gir@sko, www.alzminder.blogspot.com), that tries to combine the aforementioned four axes, yet without the variety and holistic functionality of the Symbiosis framework. Overall, it appears that Symbiosis incorporates improved, more modern and efficient versions of all the aforementioned functionalities, combining them with additional innovative technology services (AR, affective information, NUI) and features, all integrated in a system that supports the flow of information between three distinct groups, i.e., patients, caregivers and health professionals (neurologists and psychologists). It is also one of the few frameworks that takes into account the AD patient’s response and adjusts appropriately. Through this adaptability, normalization and individualization, the Symbiosis recommends a more integrated, efficient and realistic technological solution to support the Alzheimer’s Community.

Impact, Evaluation and Energy Footprint Expected Impact Symbiosis is a revolutionary system aiming at providing integrated solutions to a series of problems related with AD. It is the first integrated Alzheimer’s support system that takes into account the patient’s response in an adaptive way that fulfills each patient’s special needs and provides considerable facilitations to the caregivers and doctors. Until now, all technological solutions addressing AD focused on the satisfaction of a specific need. Using cutting-edge technology, Symbiosis provides a holistic approach to the problem which deals with the needs of all groups affected by AD, both literally and metaphorically. Alzheimer’s Associations worldwide refers to AD as an epidemic and both the medical community and the society agrees that it constitutes the great challenge of the 21st century. The World Health Organization characterized AD as ‘a public health priority’ and called governments to act on dementia. Moreover, the economic cost related with the disease exceeds $200 billion per year, regarding only the USA, whereas the psychological and emotional cost cannot be quantified. Symbiosis framework, by providing innovative solutions that facilitate all the social groups affected by Alzheimer’s directly or indirectly, holds the potential to drastically change/improve their lives. Symbiosis provides technological solutions that act as facilitator to the social integration of AD community. The AD patients have greater autonomy, feel more active through NUI-based gaming/music production and show a collaborative attitude 36

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

with caregivers, doctors and friends/AD groups. Moreover, caregivers use Symbiosis as an information source about the status of their AD patients and as a mean to come even closer, by sharing and discussing related problems with a broader community. Finally, physicians handle more AD patients and monitor them more closely, increasing their awareness and their assistive intervention in the AD patients’ living.

Evaluation Metrics The evaluation process of Symbiosis framework through scheduled pilot and large-scale case studies includes metrics upon the dimensions of ‘within time’, ‘within budget’, ‘according to requirements’ (quality and functional specifications), ‘quality of the project management process’ and ‘satisfaction of the project member’s expectations’, along with metrics upon System Quality, Information Quality, Service Quality, Information Use, Intention to Use, User Satisfaction, and Net Benefits, following the steps from system creation, experience, and organizational impacts. Moreover, metrics that directly relate to AD patients’ deficiencies, like pre- and post-testing of memory sustain, mental efficiency, spatial perception, emotional engagement, and interaction engagement, provide quantitative performance indicators of the real beneficial effect of Symbiosis in the AD community.

Energy Footprint The applicability of the Symbiosis system off-site AD centers reduces patients’ travelling to major urban centers, aimed at finding medical opinion on the current AD status of the patient. Similarly, doctors who have to frequently travel to visit and monitor patients in the province, can remotely monitor the progress and development of each Symbiosis patient-user. In addition, the independence from structures using local data storage by applying a single central storage structure (Microsoft Cloud) reduces the necessary computational resources and, consequently, their energy consumption needs associated with their use.

TRANSFERABILITY, CULTURAL ISSUES, AND FUTURE DIRECTIONS The Symbiosis users are patients over 50-55 years, while their caregivers and doctors belong to the age groups usually over 30 years, but this can have a great variation. Gender does not play a special role. Still, life-style and values ​​could play an important role, as Symbiosis is associated with personal opinions and perceptions about the concept of the family itself. More specifically, the main bilateral approach of society for the management of patients with AD, namely the coexistence of the patient with the family (the so-called extended family with several generations living under one roof or on the same property) or with lack of apparent recourse to an extended family or caretaking system, leading to his/her social marginalization and isolation (Weeks & Cuellar, 1981), has resulted in the creation of classes of users with different needs. Nevertheless, this could be covered from Symbiosis due to its versatility and modular architecture. Moreover, Symbiosis framework is designed to minimize the effect to the target audience by geographic criteria. Although originated in Greece, the impact of Symbiosis could be seen through a ‘glocal’ perspective, taking into account the distribution of the expected evolution of the AD in European countries (see Figure 21), e.g., UK 800.000, Germany 1.200.000, Nordics 198.000, Benelux 422.000 potential users (WHO).

37

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

Figure 21. The European countries with increased estimated evolution of the number of AD patients (source WHO), supporting the ‘glocal’ perspective of Symbiosis framework development.

The Symbiosis concept could also be transferred to other domains, for example, to people with stroke that need rehabilitation (i.e., physiotherapy) scenarios. The latter can be approached here through a gamification perspective (SymbioGames) to foster users’ engagement to the therapeutic task. Moreover, being a facilitator for environment normalization to the user’s skills (SymbioSpace), high-level semantics could be extracted from the use of Symbiosis panorama in everyday life of elderly, enabling further research to the identification of possible implicit or hidden correlations between different behavioral expressions or different interpretation styles of the same behavioral perspectives at this age range and study their experiential evolution and transmission from generation to generation or to other communities (for example the behavior change of an AD patient to his/her children and/ or grandchildren, but also to his/her social environment). This complies with the research initiatives lying into the area of capturing the intangible cultural treasure (coded in oral semantics, gestures and behaviors) with technological means (e.g., the FP7 i-Treasures project, http://www.i-treasures.eu/). In this way, the understanding of the role of culture in the field of aging research could be elevated, and particularly in the area of AD research, where all possible coping resources, including those of one’s ethnic heritage, need to be brought to bear. Through Symbiosis, differential human response to the same phenomena, namely AD and related disorders, could be documented and quantified, based on culturally varied normative outlooks and caretaking practices, shedding light upon the manner in which response to catastrophic illness is filtered through differing ethnic groups’ belief systems and practices. To further understand this, the fact that AD has considerable impact beyond the affected individual should always be surfaced, extending into the patient’s primary group other caretaker network and reaching into the long-term care/formal human service sector. In general, the adopted medical or disease model of AD

38

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

may exist side-by-side with traditional culture-of-origin coping beliefs and behaviors (Lefley, 1985), reflecting the biomedical research into the cultural context, as well. The modular structure, flexibility, personalization and functionality of Symbiosis significantly adds to this trajectory. Probing to the future of Symbiosis, the following discrete issues could be identified: • • • • •

Cross-case testing and evaluation of the feedback from the target group, regarding the expandability and functionality of Symbiosis, gained through ongoing contact with AD patients, caregivers and doctors at the Alzheimer Centers (nationally and abroad); Extension of Symbiosis to a multilingual system with voice recognition-based menus, enabling international use; Exploration of the new (forthcoming) versions of Kinect and Emotiv sesors and AR Google Glasses in the enhancement of the functionality, flexibility and effectiveness of Symbiosis; Further increase in the variety of games, exercises and AR scenarios; and Further customization of tasks and scenarios to different Alzheimer’s ages and cultural behaviors.

As a bottom line, it should never be neglected the fact that people react differently to different situations, especially when these are new to them. For example, some persons might find it helpful to have a recorded message that plays when they open the front door, reminding them to take their keys, while others might find this confusing. Some people may also be wary of trying new things or find it difficult to learn new skills. To this end, choosing the right assistive framework is therefore not always an easy task. If an assessment is carried out it must be detailed and person-centered, so that the solution will suit the individual and his/her situation. The presented Symbiosis framework, smoothens the AD patient’s transition to the HCI environment, simultaneously supporting the belief that assistive technology can be effective only when combined with human good care.

CONCLUSION The Symbiosis framework that sets an HCI-based symbiotic environment for Alzheimer’s support was presented in this chapter. Taking into account the specific characteristics of the whole AD community (patients, caregivers, and doctors) Symbiosis provides innovative solutions that facilitate all the social groups involved directly or indirectly, and contributes to the improvement of their quality of life. The technological solutions provided by Symbiosis act as mediator to the social integration of AD community. This is due to the fact that within the Symbiosis framework, the AD patients have greater autonomy; via the NUI they feel closer to the HCI and show a collaborative attitude towards caregivers, doctors and friends. In addition, the caregivers acquire information about the status of their AD patients and find supporting outlets coming even closer by sharing and discussing related problems with a broader community. The attending doctors handle more AD patients and monitor them more closely, from anywhere and anytime increasing their awareness and their assistive intervention in the AD patients’ living when needed. The cornerstone of Symbiosis is its emphasis placed upon normalization of the environment to the AD patient’s capabilities and personalization to his/her needs. In this way, Symbiosis proposes a more effective, realistic and complete technological solution to the problem of supporting AD community, efficiently adapting to the specificity and sensitivity of its members taking into account their cultural and social differences within a symbiotic context. 39

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

ACKNOWLEDGMENT The authors strongly acknowledge the valuable feedback from Magda Tsolaki, M.D. Neuropsychiatrist, Professor, Medical School of Aristotle University of Thessaloniki, Chair of Greek Federation of AD, and her patients. This work has received funding from the EU Seventh Framework Programme FP7-ICT-2011-9ICT-2011.8.2, under the grant agreement n° 600676: “i-Treasures” Project (http://www.i-treasures.eu).

REFERENCES Abascal, J. (2002). Human-computer interaction in assistive technology: from ‘Patchwork’ to ‘Universal Design’. IEEE International Conference on Systems, Man and Cybernetics, 3(6), 6-9. 10.1109/ ICSMC.2002.1176076 Abased, J., & Civit, A. (2001). Bridging the gap between Design for All and Assistive Devices. In C. Stephanidis (Ed.), Universal Access in HCI. Towards an Information Society for All. Hillsdale, NJ: Lawrence Erlbaum Associates. Alzheimer’s Association. (2007). Stages of Alzheimer’s Disease. Alzheimer’s Association. Retrieved January 20, 2014, from http://www.bu.edu/alzresearch/files/pdf/StagesofADAlzAssoc3.pdf Boff, K. R. (2006). Revolutions and shifting paradigms in human factors & ergonomics. Applied Ergonomics, 37(4), 391–399. doi:10.1016/j.apergo.2006.04.003 PMID:16756939 Brookmeyer, R., Johnson, E., Ziegler-Graham, K., & Arrighi, M. H. (2007). Forecasting the global burden of Alzheimer’s Disease. Alzheimer’s & Dementia, 3(3), 186–191. doi:10.1016/j.jalz.2007.04.381 PMID:19595937 Card, S. K., Moran, T. P., & Newell, A. (1980). The Keystroke-Level Model for User Performance Time with Interactive Systems. Communications of the ACM, 23(7), 396–410. doi:10.1145/358886.358895 Clarkson, B., Sawhney, N., & Pentland, A. (1998). Auditory context awareness via wearable computing. Energy, 400(600), 20. Retrieved January 20, 2014 from http://www.media.mit.edu/speech/papers/ 1998/ clarkson_PUI98_auditory_context_awareness.pdf Davidson, R. J. (1995). Cerebral asymmetry, emotion, and affective style. In R. J. Davidson & K. Hughdahl (Eds.), Brain Asymmetry (pp. 361–387). Massachusetts: MIT Press. ETSI EG 202 116 V1.2.1. (2002-09). Human Factors (HF): Guidelines for ICT products and services. Design for All, Retrieved January 20, 2014, from http://www.etsi.org Foerster, F., & Fahrenberg, J. (2000). Motion pattern and posture: Correctly assessed by calibrated accelerometers. Behavior Research Methods, Instruments, & Computers, 32(3), 450–457. doi:10.3758/ BF03200815 PMID:11029819 Förstl, H., & Kurz, A. (1999). Clinical features of Alzheimer’s Disease. European Archives of Psychiatry and Clinical Neuroscience, 249(6), 288–290. doi:10.1007004060050101 PMID:10653284

40

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

Gonzalez, A. (2010). Kinect hardware review: Wave of the future. Game Informer. Retrieved January 20, 2014, from http://www.gameinformer.com/b/news/archive/2010/11/03/kinec-hardware-review.aspx Grootjen, M., Neerincx, M. A., van Erp, J. B. F., & Veltman, J. A. (2010). Human-computer symbiosis by mutual understanding. CHI 2010, Atlanta, Georgia, USA. ACM 978-1-60558-930-5/10/04. Retrieved from http://www.eecs.tufts.edu/~agirou01/workshop/papers/grootjen-CHI2010-BrainBodyBytes2010.pdf Kyprioti, A., & Toumpas, K. (2013). Development of algorithms and comparative analysis for the estimation of the cardiac rhythm using optic and depth cameras. Unpublished Diploma Thesis (in Greek), Dept. of Electrical & Computer Engineering, Aristotle University of Thessaloniki, Greece. Lauriks, S., Reinersmann, A., Van der Roest, H. G., Meiland, F. J. M., Davies, R. J., Moelaert, F., ... Dröes, R. M. (2007). Review of ICT-based services for identified unmet needs in people with dementia. Ageing Research Reviews, 6(3), 223–246. doi:10.1016/j.arr.2007.07.002 PMID:17869590 Lefley, H. P. (1985). Families of the mentally ill in cross-cultural perspective. Psychosocial Rehabilitation Journal, 8(4), 57–75. doi:10.1037/h0099658 Meek, P. D., McKeithan, K., & Schumock, G. T. (1998). Economic considerations in Alzheimer’s Disease. Pharmacotherapy, 18(2 Pt 2), 68–73. PMID:9543467 Robert, P. H., Konig, A., Andrieu, S., Bremond, F., Chemin, I., Chung, P. C., ... Mallea, P. (2013). Recommendations for ICT use in Alzheimer’s disease assessment: Monaco CTAD expert meeting. The Journal of Nutrition, Health & Aging, 17(8), 653–660. doi:10.100712603-013-0046-3 PMID:24097018 Sampaio, C. (2007). Clinical relevance on Alzheimer’s disease endpoints. The Journal of Nutrition, Health & Aging, 11(4), 316–317. PMID:17653488 Stephanidis, C. (Ed.). (2001). User interfaces for all: concepts, methods, and tools. London: Routledge. Thompson, C. A., Spilsbury, K., Hall, J., Birks, Y., Barnes, C., & Adamson, J. (2007). Systematic review of information and support interventions for caregivers of people with dementia. BMC Geriatrics, 7(1), 18http://www.ncbi.nlm.nih.gov/pmc/ articles/PMC1951962/. Retrieved January 20 2014. doi:10.1186/1471-2318-7-18 PMID:17662119 Wang, S., Pentney, W., Popescu, A. M., Choudhury, T., & Philipose, M. (2007). Common sense based joint training of human activity recognizers. In IJCAI, 7 (pp. 2237-2242). Weeks, J. R., & Cuellar, J. B. (1981). The role of family members in the helping networks of older people. The Gerontologist, 21(4), 388–394. doi:10.1093/geront/21.4.388 PMID:7262568

KEY TERMS AND DEFINITIONS Alzheimer’s Disease (AD): The most common form of dementia. Augmented Reality (AR): A live, copy, view of a physical, real-world environment whose elements are augmented (or supplemented) by computer-generated sensory input such as sound, video, graphics or GPS data.

41

 Towards an HCI-Based Symbiotic Environment for Alzheimer’s Support

Extended Family: A family that extends beyond the immediate family, consisting of grandparents, aunts, uncles, and cousins all living nearby or in the same household. Human-Computer Interaction (HCI): Involves the study, planning, and design of the interaction between people and computers. Intangible Treasures (i-Treasures): Important intangible cultural heritages, i.e., different oral and intangible treasures of humankind worldwide, identified by UNESCO as an essential component and a repository of cultural diversity and creative expression. Mild Cognitive Impairment (MCI): Also known as incipient dementia, or isolated memory impairment, MCI is a brain function syndrome involving the onset and evolution of cognitive impairments beyond those expected based on the age and education of the individual, but which are not significant enough to interfere with their daily activities. Natural User Interface (NUI): The common parlance used by designers and developers of humanmachine interfaces to refer to a user interface that is effectively invisible, and remains invisible as the user continuously learns increasingly complex interactions. Serious Games: A game designed for a primary purpose other than pure entertainment. The ‘serious’ adjective is generally prepended to refer to products used by industries like defense, education, scientific exploration, health care, emergency management, city planning, engineering, religion, and politics. Symbiosis: Companionship, to live together.

ENDNOTE

1

Symbiosis (Greek Συμβίωσις), means companionship, from ‘symbioun’, to live together, from ‘symbios’, living together: ‘syn + bios (life)’.

This research was previously published in the Handbook of Research on Innovations in the Diagnosis and Treatment of Dementia edited by Panagiotis D. Bamidis, Ioannis Tarnanas, Leontios Hadjileontiadis, and Magda Tsolaki, pages 240-268, copyright year 2015 by Medical Information Science Reference (an imprint of IGI Global).

42

43

Chapter 3

Assistive Technologies and the Carers of People With Dementia: Empowerment and Connection Sarmishtha Bhattacharyya University of Chester, UK Susan Mary Benbow University of Chester, UK

ABSTRACT Assistive technologies have a role in supporting both formal and informal carers of people with dementia, and in maintaining the independence, and quality of life of both people with dementia and their carers. The authors report a narrative review of the use of technological interventions to empower the carers of people with dementia, and relate this to a model of ageing well. They argue that this highlights the importance of empowering and connecting with carers in order to increase their participation and connection in the care of their relative/client; and conclude that both empowerment and connection contribute to maintaining autonomy and well-being of both carers and people with dementia. Technological interventions should not be used as alternatives to connection. The emphasis in practice should be on empowering and connecting with both carers and people with dementia.

INTRODUCTION In the United Kingdom (UK) currently, there are about 800,000 people with dementia, of whom approximately 665,000 live in England. Dementia costs the UK economy £17 billion a year, and, in the next 30 years, the number of people with dementia in the UK will double to 1.4 million, with care costs trebling to over £50 billion per year (Alzheimer’s Society, 2007). The care of people with dementia presents a huge challenge to society now, and demand is set to increase further in the future. There are approximately six million carers in the UK: 1.4 million of them provide unpaid care for more than 50 hours per week (Office for National Statistics, n/d; The NHS Information Centre Social Care Team, 2010). The work of unpaid carers makes a significant contribution to the UK economy, and DOI: 10.4018/978-1-5225-7122-3.ch003

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Assistive Technologies and the Carers of People With Dementia

it is estimated that carers save the taxpayer approximately £119 billion per year (Buckner & Yeandle, 2011), equivalent to £2.3 billion per week. The Alzheimer’s Society estimates that there are 670,000 people in the UK acting as primary carers for people with dementia (Alzheimer’s Society, 2012) and unpaid informal carers are a major part of the support system for people with dementia. Many of the carers of people with dementia are themselves elderly, and may have long-term health conditions or disability. Two-thirds of all people with dementia live in their own homes with unpaid carers providing most of their support. The EUROCARE study (Schneider, Murray, Banerjee, & Mann, 1999) found that half of all people with dementia in the community received at least 35 hours of informal care per week. Although many carers report personal satisfaction from their caring role, it is recognised that unpaid caring has a considerable impact on the carer’s health and well-being and can lead to emotional and physical exhaustion, depression, poor general health and isolation (Alzheimer’s Society, 2013a). The impact of dementia on the families of those with the condition is profound. Dementia results in a progressive decline in multiple areas of function, including memory, communication, language and daily living skills (Department of Health, 2009). Moreover, people with dementia may develop behavioural and psychological symptoms (BPSD) such as depression, psychosis, aggression or wandering. BPSD are common, often problematic for carers, and may affect almost all people with dementia (Savva et al., 2009), complicating care at any stage of the illness.

Formal and Informal Carers of People with Dementia People with dementia are cared for both by formal and informal carers. Family carers of people with dementia may be old and frail themselves, with high levels of depression and physical illness, and a diminished quality of life (Alzheimer’s Society, 2007). Carers of people with dementia also experience greater strain and distress than carers of older people with other long-term conditions (Moise, Schwarzinger, Um, & the Dementia Experts’ Group, 2004). Many carers of people with dementia, particularly those caring for someone in the later stages of the illness, feel ill-equipped to deal with agitated behaviours (Newbronner, Chamberlain, Borthwick, Baxter, & Glendinning, 2013). BPSD not only causes significant distress in carers but is often the singular most important factor in the early institutionalisation of people with dementia. Hence, training and support for carers are regarded as potentially valuable: expert carers programmes offer a way of delivering training and peer support to enable carers to care for their loved ones for as long as possible. Traditional ways of meeting the needs of people with dementia continue to involve institutionalisation. Approximately half a million people in Britain live in residential, or nursing homes looked after by care staff or formal carers and about four-fifths of those in care homes have dementia (Independent Commission on Whole Person Care, 2014). In addition, people with dementia living in the community frequently receive formal care provided by paid staff from health and social services providers in their own homes and during hospital admissions. This staff ranges from qualified professionals such as nurses to care staff with few or no formal qualifications. Due to challenges in communication and a lack of understanding of dementia, there is concern that formal care of people with dementia in all settings often fails to promote dignity and respect and may sometimes breach fundamental human rights (Alzheimer’s Society, 2014; Tadd et al., 2011). Challenges remain in ensuring the formal care workforce is effectively prepared to provide dementia care, and MacDonald and Cooper (2007) predicted a crisis of availability of institutional care places for people with dementia, calling for investment in affordable good quality domiciliary care. The main function of long-stay care for old people is now to provide for 44

 Assistive Technologies and the Carers of People With Dementia

people with advanced dementia. Yet despite the increasing numbers of people living with dementia, the number of available care home places for people with dementias is expected to reduce in the UK due to radical change in provision of long-term care, partly resulting from falling numbers of hospital beds available for long stay care, but also from changes in national policy. Unfortunately failings in institutional care, and particularly the care of people with dementia, have been repeatedly highlighted over recent years (Benbow, 2008). The influential Francis report (2013) found an institutional culture which tolerated poor standards and risk to patients. Recently several television programmes in the UK have highlighted the use of technology (cameras) by relatives concerned about failings in care. The use of cameras raises several issues – on one hand concerns on ethical or moral grounds about recording a patient who is unable to consent to such a device being placed in their room; on the other hand (and on a positive note) such devices could highlight good examples of care and might reassure and encourage both families and formal care staff. Might technological interventions offer a means of improving the quality of institutional care?

Assistive Technologies: The Context In England and Wales, the use of assistive technologies emerged largely from social alarm technologies first used within local authority sheltered housing in the 1960s and 70s (Fisk, 2003). These technologies are reported to promote independence and autonomy, both for the person with dementia and those around them; to help manage potential risks in and around the home in order to reduce early entry into care homes and hospitals; to facilitate memory and recall; and to reduce the stress on carers, thereby improving their quality of life, and that of the person with dementia (Alzheimer’s Society, 2013b). However the evidence base for assessing cost effectiveness and benefits of using assistive technologies is scattered, and methodologies for assessing cost-effectiveness and outcomes are varied (Bowes, Dawson, & Greasley-Adams, 2013). For technology to be successful, most writers suggest that it should be introduced at an early stage in the course of a disease (Cahill, Macijauskiene, Nygård, Faulkner, & Hagen, 2007; Rasquin, Willems, de Vlieger, Geers, & Soede, 2007). Familiarity with the technology is essential but minimal new learning should be required from people with dementia (Cahill et al., 2007), and design is crucial (Bharucha et al., 2009; Cahill et al., 2007; Gilliard, 2001). There are ethical dilemmas, particularly regarding the use of technology to reduce risk and improve safety in people with dementia who are unable to give consent to the intervention. The hope is that technologies have huge potential for the future care of an increasingly aged population, especially in offering more cost effective care (Bowes et al., 2013) but also in improving services and improving the quality of life of people with dementia and their carers. In this paper we review whether technological interventions for people with dementia might offer their carers increased empowerment and connection, relating the evidence to a model of ageing well.

METHOD We have conducted a narrative review of the use of technological interventions to empower the carers of people with dementia and reflect on the implications of these technologies for both carer and person with dementia.

45

 Assistive Technologies and the Carers of People With Dementia

We use the following definitions. Assistive technology is a broad term covering ‘any item, piece of equipment, product or system, whether acquired commercially, off the shelf, modified or customised, that is used to increase, maintain or improve functional capabilities of individuals with cognitive, physical or communication disabilities’ (Marshall, 2000),: this includes information and communications technology (Audit Commission, 2004). Telecare is defined as the delivery of care from a distance through computers and telecommunications systems (Magnusson, Hanson, & Borg, 2004): it ‘involves a range of services including virtual visiting, reminder systems, home security, and social alarm systems with the overall aim of avoiding hospitalisation and aiding ageing in place’ (NICE/ SCIE, 2007, p. 168). We relate the literature identified in the review to a model of ageing well and the environment taken from the work of Wahl and colleagues (Wahl, Iwarsson, & Oswald, 2012).

RESULTS AND DISCUSSION Our hypothesis is that technological interventions offer a means of increasing carers’ empowerment and connection in the caring situation. How then might we conceptualise this? We have used Peck and coworkers’ three “conceptions” which might be applied to carers of people with dementia (Bhattacharyya & Benbow, 2015). These conceptions identify carers as recipients; carers as subjects of consultation; and carers as agents in control (Peck, Gulliver, & Towel, 2002). These “conceptions” bear similarities to Arnstein’s (1969), the ladder of participation which describes how people can take charge of their lives. However, empowerment alone may not be sufficient to improve the quality of life, and can usefully be set within Wahl et al.’s (2012) conceptual framework on ageing well and the environment (see Figure 1). Figure 1 represents how empowerment, in conjunction with the connection, contributes to identity, autonomy and well-being. Figure 1. A conceptual framework modified from the work of Wahl et al (2012)

46

 Assistive Technologies and the Carers of People With Dementia

Increasing Connection Using Technologies Table 1 gives details of studies reporting results which may be regarded as increasing connection for people with dementia and their carers. Three are review papers. Godwin and colleagues (2013) reviewed randomised controlled trials (RCTs) of technology driven interventions and found 8 papers from 4 RCTs, all of which provided information and social support. The authors note that carers responded positively to online education; and internet-based support groups. Although all the papers reported some positive findings, it was difficult to draw conclusions for a number of reasons, including the small numbers of trials identified; variability in the intervention and its delivery; and variability in outcomes studied. Powell and colleagues (2008) looked at networked technologies and highlighted similar problems, but noted a “moderate” effect on carer stress and depression: the studies they reviewed involved networked peer support. Topo’s (2009) literature review found technology used primarily to provide information, education or support to carers, either from carer-peers or professionals. Six papers in Table 1 report research studies: two are RCTs, two report quantitative research, one reports quantitative and qualitative findings, and one a qualitative evaluation. The two RCTs are from the same group, which has carried out research on the provision of psychological therapies for families living with dementia. One trial reported a decrease in carers’ depressive symptoms (Mittelman, Brodaty, Wallen, & Burns, 2008) and the other an improvement in carers’ self-rated health (Mittelman, Roth, Clay, & Haley, 2007). The focus in both these trials was on using technology to reduce the impact of caring on carers rather than to empower them, but at the same time providing therapy/ counselling/ support as a way of fostering connection. Eisdorfer et al. paper (2003) and that of Gallagher-Thompson and colleagues (2010) can be viewed similarly, as both focused on the role of technology in alleviating carer depression and/or stress and both involved methods of providing therapy and support. The combined quantitative and qualitative study by Marziali and Garcia (2011) involved technology in providing support groups, with a focus that again is on connection rather than empowerment. Carers were supported to carry on caring rather than empowered to take control of their situations. The final paper by Upton and colleagues (2011) is different in focusing on the use of tablet computers by formal carers in care homes, and although these devices may have the potential to improve residents’ quality of life they also encourage engagement and communication (connection) between staff with residents, rather than empowering either party. Most of these papers report the use of low-level technologies and focus on informal carers. Increasing support to carers or providing them with education may be valuable: it might contribute to the well-being of carers and people with dementia but falls within the sphere of connection rather than empowerment. The potential for technology to empower carers and give them more control in their caring role is not tapped in these studies.

Tokenism: Carers’ Use of Technology as Subjects of Consultation Tokenism involves consulting with carers or service users but without them having the power to influence services or events. An example of this is a study by Rosenberg and colleagues (2012), who carried out a qualitative project investigating carers’ experiences, feelings and thoughts concerning technology and their relatives as technology users. These findings may be useful in planning how to employ technologies to empower carers. For example, remote consultations may give carers more control or power in the care of the person with dementia if the carer uses the consultation to become more actively involved

47

 Assistive Technologies and the Carers of People With Dementia

Table 1. Characteristics of papers which increase connection for carers Paper

Eisdorfer et al, 2003

GallagherThompson at al, 2010

Type of paper

Experimental: quantitative

Experimental: quantitative

Carers; country

Summary of what was done

Summary of findings and conclusions

225 family carers; White American and Cuban American; USA

Compared structural eco-systemic therapy without technology with therapy combined with computertelephone integrated system allowing education/ training plus access to support for carers of people with Alzheimer’s disease.

Carers who received the combined intervention had fewer depressive symptoms at 6 month follow up. Authors suggest a role for technology in alleviating depression/ distress.

70 informal Chinese-American carers; USA

DVD delivered 12 week cognitive behavioural therapy skills training package for Chinese-American carers of people with dementia compared with DVD delivered educational intervention.

Carers in the Skills training group reported higher levels of positive affect; reported that patient behaviors were less stressful/ bothersome; were more satisfied with the program overall; and believed they could give care more effectively. Found 8 papers from 4 RCTs with some positive findings reported but conclude that were unable to draw conclusions because of small number of RCTs; variability in delivering the intervention; variability in outcomes selected.

Godwin et al, 2013

Systematic review

Informal carers

Review of randomised controlled trials (RCTs) of technology based interventions excluding telephone contact only; videotape/ CD only; decision aid only.

Marziali and Garcia, 2011

Experimental: quantitative + qualitative

91 dementia carers; Canada

Internet based support group for carers compared with an internet-based video conferencing support group.

Found video conferencing support group benefitted carers’ mental health and stress levels.

158 spouse carers; USA, UK and Australia

Individual and family counselling combined with ad hoc telephone counselling for carers of people with Alzheimer’s disease on anti-Alzheimer drug treatment compared with drug treatment alone.

Intervention decreased depressive symptoms amongst carers.

406 spouse carers; USA

Individual and family counselling combined with ad hoc telephone counselling for carers of people with Alzheimer’s disease compared with usual care.

Intervention group had improved selfrated health, maintained for 2 years.

Mittelman et al, 2008

Mittelman et al, 2007

Experimental: RCT

Experimental: RCT

Powell et al, 2008

Systematic review

Informal carers

Review of the benefit of networked technologies in carer support.

Found 15 papers describing 5 interventions all including some aspect of peer support. Outcomes found to be inconsistent but moderate effect on carers stress and depression.

Topo, 2009

Literature review

Carers, formal and informal

Review of studies focused on using technology to support people with dementia and their carers.

Found 46 studies and 1 review. Most studies involved formal carers in care homes. Few involved people with dementia actively using the technology.

The use of touch screen technology in care homes for people with dementia and their carers.

They found a number of potential benefits including: - Use in reminiscence/ life history work - Assisting recall - Increasing communication and engagement with others - on staff-resident relationships

Upton et al, 2011

48

Experimental: qualitative

Formal carers in care homes; UK

 Assistive Technologies and the Carers of People With Dementia

in assessment, care planning and decision-making. However if the consultation serves only to use the carer as an information source, they are operating as a subject of consultation only.

Empowerment: Increasing Power and Control Using Technologies Table 2 sets out details of seven papers offering some support for the hypothesis that access to technology can empower people with dementia and their carers. Four are review papers and only three present experimental data; one of these is based on the study of one man with dementia. One review looked at the use of Skype for remote healthcare consultations (Armfield, Gray, & Smith, 2012). Although there are good arguments to suggest that its use should be potentially beneficial and might give people with dementia and their family carers easier access to health and social care service providers, the reviewers found little evidence in the literature to support this. Another review of Smarthome projects (Cash, 2003) highlighted the importance of acceptability to the person with dementia and their family alongside potential concerns about commercial pressures and possible fostering of dependency: Nevertheless, this technology has the potential to empower people with dementia to remain more independent whilst relieving carers of some of their burden and anxieties. Lauriks and colleagues (2007) concluded that people with dementia and their carers need to decide on, and have control over, reminders and prompts employed in daily life; and also that the use of electronic memory aids (EMAs) benefits both carers and people with dementia; Magnusson (2004) and colleagues’ review highlighted the need to actively involve potential users and their carers in the research and development of products and services: this is a way of empowering both users and carers to develop products which meet their needs. The three papers presenting experimental data focus on tagging (2 papers) (Miskelly, 2004, 2005) and evaluation of a Smarthome project (1 paper) (Orpwood, Adlam, Evans, Chadd, & Self, 2008). Concerns about the ethics of tagging continue and have not been fully resolved: the main tension is the balance between safety and independence versus autonomy. There is also concern about how decisions to employ tagging are made (White & Montgomery, 2014). An alternative approach to tagging someone who is unable to find their way in order to be able to locate them using global positioning technology at a future point in time, would be to develop a technological means of guiding people to their destination when walking or driving (Robinson, Brittain, Lindsay, Jackson, & Olivier, 2009). Such an electronic guide would empower the person and their family. The report of the Smarthome project is limited in that it presents data in respect of only one resident and his family carer (Orpwood et al., 2008). If technology is employed to support people with dementia in remaining at home in the community safely, where that is their wish, and to relieve their carers of burden and anxieties, it may be regarded as empowering both users and carers. Where the person and their family carers are involved in developing or setting up the technology to meet areas of concern identified by them, the use of technology is giving some degree of power and control to both family carer and the person with dementia. Robotics technology may offer additional potential benefits to families, and, in future, might contribute to the quality of life of carers and people with dementia living on their own or in care homes, provided ethical concerns are resolved.

Advantages and Challenges in the Use of Technologies Technology-driven interventions offer convenient, low-cost alternatives for delivering interventions to carers and people with dementia at any time of day or night. If used to support people with dementia to 49

 Assistive Technologies and the Carers of People With Dementia

Table 2. Characteristics of technology studies which suggest ways to give carers power/control in the care of the person with dementia Paper Armfield et al, 2012

Cash, 2003

Type of paper Literature review

Narrative review

Carers; country Carers of elderly patients with dementia

Focused on people with dementia.

Summary of what was done

Summary of findings and conclusions

Reviewed the use of Skype for remote healthcare consultations.

Authors argue that Skype might have a useful role in follow up consultations, counselling, or even full diagnostic assessment/ consultation, but found little evidence to support this.

Review of a number of assistive technology projects focused on people with dementia but can be extrapolated to consider implications for their carers.

Author discusses several Smarthome projects, and areas of safety highlighted include the following:      - Safety with gas      - Temperature control      - Potential flooding      - Possible falls, especially nocturnal      - Medication dispensing      - “Wandering” - Forgetting/ losing keys Potential to empower both carer and person with dementia.

Lauriks et al, 2007

Literature review

Family carers of people with dementia

Review of information and communication technology based services in relation to carers and people with dementia.

Found 12 publications addressing “the need for health monitoring and perceived safety”. Studies of the use of electronic memory aids (EMAs) in assisting memory and organization found them acceptable for people with moderate to severe brain injury although the literature on their use for people with dementia was limited and generally uncontrolled. Reviewers concluded that people with dementia and their carers need to decide on, and have control over, reminders and prompts employed; also that carers motivate people with dementia to use EMAs and both carers and people with dementia benefit from their use

Magnusson et al, 2004

Literature review

Family carers of frail older people

Reviewed the use of information and communication technology (ICT) as a support for frail older people living at home and their family carers.

Found 84 articles; 22 conference papers; 20 reports; and 13 books/book chapters and identified key themes in the literature. The authors highlight the need to actively involve potential users and carers in the research and development of products and services.

“Patients with dementia”

Tested tagging equipment in three different environments: two teaching hospital wards; a care home; and the homes of people with dementia in the community, aiming to address wandering. The person monitored wore a bracelet radio transmitter, which emitted a signal detected by monitoring stations. When the person left a safe zone or entered a risk area, information was transmitted to a central base station and a warning was transmitted using a pager to staff. A variation of the system was tested in the community using one bracelet, one pager and one monitor.

The system was found to be reliable, compliance was good, and two incidences of wandering outside the care home were detected. Families, people with dementia and staff members did not regard tagging as ethically unacceptable or contra-indicated.

Miskelly, 2004

Miskelly, 2005

Orpwood et al, 2008

50

Experimental: descriptive

Experimental: quantitative

“Patients with dementia”

Use of a GPS-enabled mobile telephone to locate people with dementia.

Enabled people to be located reliably and with an accuracy of approximately 5 metres, except when inside buildings or on public transport systems. User compliance was an issue when the family carer did not understand how to set up the phone correctly: this led to frustration and rejection of the technology.

Experimental: quantitative

One man with moderate/ severe vascular dementia (scoring 10/30 on Mini Mental State Examination)

Describes “a complete autonomous smart home installation in an apartment in a care home”. They studied the behaviour of the subject before and after switching on the technology.

They found improvements in urinary continence; sleep pattern; and “night-time wanderings”. The man’s daughter reported that it relieved her concerns and she felt it enabled her father to be more independent and safe. Care staff members were concerned that the project might affect their workloads, but later reported that they felt the man settled and became calmer over time.

 Assistive Technologies and the Carers of People With Dementia

remain in their own homes in the community they may save institutional care costs and enable people to retain their independence for as long as possible. Activity and reminiscence focused materials may improve the quality of life. Telemedicine may improve health outcomes. Potential roles for technology include supporting and facilitating a person’s memory, orientation, and other cognitive abilities; enabling the person to carry out tasks and activities that are (potentially) moving beyond their reach; facilitating meaningful occupation during the day, including leisure activities, supporting the maintenance of valued roles in the family and other social networks; and ensuring the person’s safety and support and reassure carers (Wey, 2006). All these promote independent living and the well-being of both the user and their carers. Many of these benefits apply to formal care settings as well as care at home, but utilising technologies may avoid or delay nursing home placement of people with dementia (Cash, 2003; Spruytte, Van Audenhove, & Lammertyn, 2001). Similarly, technology may offer increased connection and could perhaps prevent social isolation and loneliness, but not if it is employed at the expense of personal contact. Might assistive and telecare technologies be used as a substitute for social care rather that to support and complement it? Whilst this may suit some who resent the intrusion of care services into their lives, the loss of social contact for people with dementia who may already be experiencing social isolation and problems with communication is likely to adversely affect the quality of life (Woolham, Gibson, & Clarke, 2006).Technological interventions should be person centred and accommodate individual variations and preferences (Gitlin et al., 2003). One major concern with the use of technology in the care of people with dementia is an ethical issue around consent. Cash (2003) argues that whilst technology has the capacity to facilitate communitybased care and reduce carer stress, its use raises ethical dilemmas and conflicts. The main issue is that of informed consent to technological interventions. Some people with dementia will be competent to make their own decisions about the use of assistive technology. Others may be unable to make decisions for themselves on this as a result of cognitive impairment related to their dementia. Yet, technologies may enable them to maintain autonomy: pragmatic decisions need to be made in the context of the Mental Capacity Act 2005 that strike a balance between preserving autonomy and ensuring that both the person with dementia and their carer are safe and have a good quality of life. The views and attitudes of family carers regarding the use of assistive technologies may influence whether technologies are acceptable and whether they are successful. A qualitative study of carers’ experiences, feelings and thoughts concerning technology and their relatives as technology users found that carers emphasized the importance of using technology as a way of helping people with dementia to retain their abilities and engage in a physically and mentally active lifestyle (Rosenberg et al., 2012). Designing products for the active use of people with dementia is challenging because any solutions need to be easy to use; not demanding in terms of new learning and introduced early enough for the benefit to be maximised (Orpwood et al., 2004; Orpwood et al., 2008). Carer and person with dementia may have different perspectives in relation to the need for technological intervention, particularly where there are concerns about safety and risk, e.g., in relation to the installation of surveillance technology (Nygård & Johansson, 2001; Topo et al., 2007). Safety issues can have a powerful influence on carers’ well-being and quality of life (Cahill et al., 2007; Gitlin & Chee, 2006) and in some instances carers may consider them to outweigh ethical dilemmas, such as privacy/ dignity and restricting the integrity and autonomy of the person with dementia (Rosenberg et al., 2012). Technology use in daily activities may be an important means of continuing to exercise retained abilities, but could also be a possible threat to health, by prematurely stopping people from engaging

51

 Assistive Technologies and the Carers of People With Dementia

in activities; and marking people out as different. Users may be deterred from using technologies they regard as stigmatising because they are visible and associated with old age and/ or disability (Rosenberg et al., 2012).

CONCLUSION Table 3 summarises some of the main areas where technologies have the potential to contribute to empowerment and/ or connection amongst the carers of people with dementia. Connection includes a Table 3. Broad areas of intervention using technologies – suggested relationships to empowerment and connection Area of intervention 1

2

3

4

52

Connection

Communication devices

Possibly -Easier communication with PWD

Yes

Entertainment

No

No

Leisure-related

No

Possibly

Peer support (carers/ people with dementia)

No

Yes

Falls monitoring

Yes – encourages autonomy

No

Information exchange/ sharing

Possibly – if carer included

Yes

Personal alarms

Yes – encourages autonomy

No

Physiological monitoring

Yes – encourages autonomy

No

Remote consultation (medical/ nursing/ other)

Yes – encourages autonomy

Yes – connection with health/ social care staff

Environmental controls e.g. temperature

Yes – encourages autonomy

No

Medication management

Yes – encourages autonomy

No

Movement/ door sensors

Yes – encourages autonomy

No

Navigational aids/ GPS systems

Yes – encourages autonomy

Possibly if increased autonomy allows increased connection with others

No

No

Health monitoring

Independence maintaining function

Memory – related function Appointment reminder systems

5

Empowerment

Activity/ occupation function

Electronic prompts/ cues

No

No

Information

No

No

Brain training

Possibly - encourages autonomy

No

Computer games

Possibly - encourages autonomy

No

Mental stimulation

 Assistive Technologies and the Carers of People With Dementia

connection with people, with the environment and with the past, present and future. Assisting carers to connect with people with dementia through technological interventions and to connect with others who offer them support potentially enables carers to maintain their identity, autonomy and well-being. The identity of carer may over-whelm other aspects of identity: for example, a wife caring for her husband with dementia might feel that she is no longer a wife to her husband but only his carer, and that she is unable to fulfill her other roles as mother, grandmother, friend, and citizen, because her time is taken up with caring (Benbow & Kingston, 2014). Technology can free carers up to maintain important roles and activities outside that of carer, and to maintain important aspects of their autonomy that otherwise might become sacrificed to caring duties. In these ways, technological interventions contribute to carer health and wellbeing as well as the health and well-being of the person being caring for. What of the future? The great-grandparents of today were born and raised before the age of the computer, whereas their great grandchildren are ‘digital natives’ and the generations between are ‘digital immigrants’ (Prensky, 2001). There will be cohort/ generational differences in what technologies are acceptable and/or wanted: older people in future will have used technologies throughout their lives and will expect to continue using them. Robotics technology may offer ways of improving the quality of life of lonely, isolated older people living on their own or in nursing homes, both by compensating for lost competencies (agency) but also by offering new ways of connecting (perhaps to a robotic animal or by enjoying virtual realities). There is some evidence that people with dementia may experience stimulation, pleasure and interest from interacting with an animal, entertainment, and therapeutic robots (Libin & Cohen-Mansfield, 2004; Shibata & Wada, 2011; Tamura et al., 2004). New forms of communication media are enabling grandparents to keep in touch with their grandchildren (Quadrello et al., 2005): this is another way that technologies may enhance well-being and reduce social isolation and it is likely to become increasingly normal and accepted for future generations. Assistive technologies already have a role in empowering and enhancing connection for carers of people with dementia and their relatives/ clients with dementia. This role is likely to expand in future as increasing numbers of people develop dementia and are in need of formal and informal care. Although the ethical dilemmas involved in the use of technology need to be debated and addressed, possible ways in which assistive technologies may contribute to the well-being of carers and people with dementia now and in future are exciting and continue to evolve.

REFERENCES Alzheimer’s Society. (2007). Dementia UK. The full report. (pp. 165). London. Alzheimer’s Society. (2012). Dementia 2012: A national challenge Retrieved from http://alzheimers.org. uk/site/scripts/download_info.php?fileID=1390 Alzheimer’s Society. (2013a). Carer support Retrieved from http://www.alzheimers.org.uk/site/scripts/ documents_info.php?documentID=546 Alzheimer’s Society. (2013b). Assistive technology – devices to help with everyday living. Factsheet 437LP Retrieved from http://www.alzheimers.org.uk/site/scripts/download_info.php?fileID=1779 Alzheimer’s Society. (2014). Formal COF people with dementia Retrieved from http://www.alzheimers. org.uk/site/scripts/documents_info.php?documentID=402

53

 Assistive Technologies and the Carers of People With Dementia

Armfield, N. R., Gray, L. C., & Smith, A. C. (2012). Clinical use of Skype: A review of the evidence base. Journal of Telemedicine and Telecare, 18(3), 125–127. doi:10.1258/jtt.2012.SFT101 PMID:22362829 Arnstein, S. R. (1969). A Ladder of Citizen Participation. Journal of the American Institute of Planners, 35(4), 216–224. doi:10.1080/01944366908977225 Audit Commission. (2004). Assistive Technology. Independence and well-being 2 Retrieved from http:// archive.audit-commission.gov.uk/auditcommission/SiteCollectionDocuments/AuditCommissionReports/ NationalStudies/FullATReportforweb.pdf Benbow, S. M. (2008). Failures in the system: Our inability to learn from inquiries. Journal of Adult Protection, 10(3), 5–13. doi:10.1108/14668203200800015 Benbow, S. M., & Kingston, P. (2014, September 22). ‘Talking about my experiences ... at times disturbing yet positive’: Producing narratives with people living with dementia. Dementia. Bharucha, A. J., Anand, V., Forlizzi, J., Dew, M. A., Reynolds, C. F. S. III, Stevens, S. H., & Wactlar, H. (2009). Intelligent Assistive Technology Applications to Dementia Care: Current Capabilities, Limitations, and Future Challenges. The American Journal of Geriatric Psychiatry, 17(2), 88–104. doi:10.1097/ JGP.0b013e318187dde5 PMID:18849532 Bhattacharyya, S., & Benbow, S. M. (2015). Carers of people with dementia and the use of assistive technologies. In F. Xhafa, P. Moore, & G. Tadros (Eds.), Advanced Technological Solutions for Dementia Patient Monitoring (pp. 12–35). Hershey, PA, USA: IGI Global. doi:10.4018/978-1-4666-7481-3.ch002 Bowes, A., Dawson, A., & Greasley-Adams, C. (2013). Literature review: the cost effectiveness of assistive technology in supporting people with dementia. Report to the Dementia Services Development Trust. Retrieved from http://dementia.stir.ac.uk/system/files/filedepot/30/the_cost_effectiveness_of_assistive_technology_in_supporting_people_with_dementia_october_13.pdf Buckner, L., & Yeandle, S. (2011). Valuing carers 2011: Calculating the value of carers’ support. Centre for international research on care labour & equalities. Retrieved from http://circle.leeds.ac.uk/ files/2012/08/110512-circle-carers-uk-valuing-carers.pdf Cahill, S., Macijauskiene, J., Nygård, A.-M., Faulkner, J.-P., & Hagen, I. (2007). Technology in dementia care. Technology and Disability, 19, 55–60. Cash, M. (2003). Assistive technology and people with dementia. Reviews in Clinical Gerontology, 13(4), 313–319. doi:10.1017/S0959259804001169 Department of Health. (2009). Living well with dementia: A National Dementia Strategy Retrieved from http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/ DH_094058 Eisdorfer, C., Czaja, S. J., Loewenstein, D. A., Rubert, M. P., Arguelles, S., Mitrani, V. B., & Szapocznik, J. (2003). The effect of a family therapy and technology-based intervention on caregiver depression. The Gerontologist, 43(4), 521–531. doi:10.1093/geront/43.4.521 PMID:12937331 Fisk, M. J. (2003). Social Alarms to Telecare: Older People’s Services in Transition. Bristol: Policy Press.

54

 Assistive Technologies and the Carers of People With Dementia

Francis, R. (2013). Report of the Mid Staffordshire NHS Foundation Trust Public Inquiry. Executive summary. London. Gallagher-Thompson, D., Wang, P.-C., Liu, W., Cheung, V., Peng, R., China, D., & Thompson, L. W. (2010). Effectiveness of a psychoeducational skill training DVD program to reduce stress in Chinese American dementia caregivers: Results of a preliminary study. Aging & Mental Health, 14(3), 263–273. doi:10.1080/13607860903420989 PMID:20425645 Gilliard, J. (2001). Technology in practice: Issues and implications. Journal of Dementia Care, 9(6), 18–19. Gitlin, L. N., Belle, S. H., Burgio, L. D., Czaja, S. J., Mahoney, D., Gallagher-Thompson, D., ... Ory, M. G. (2003). Effect of Multicomponent Interventions on Caregiver Burden and Depression: The REACH Multisite Initiative at 6-Month Follow-Up. Psychology and Aging, 18(3), 361–374. doi:10.1037/08827974.18.3.361 PMID:14518800 Gitlin, L. N., & Chee, Y. K. (2006). Use of Adaptive Equipment in Caring for Persons with Dementia at Home. Alzheimer’s Care Today, 7(1), 32–40. Godwin, K. M., Mills, W. L., Anderson, J. A., & Kunik, M. E. (2013). Technology-Driven Interventions for Caregivers of Persons with Dementia: A Systematic Review. American Journal of Alzheimer’s Disease and Other Dementias, 28(3), 216–222. doi:10.1177/1533317513481091 PMID:23528881 Independent Commission on Whole Person Care. (2014). One Person One Team One System Retrieved from http://www.pwc.co.uk/en_UK/uk/assets/pdf/one-person-one-team-one-system.pdf Lauriks, S., Reinersmann, A., Van der Roest, H. G., Meiland, F. J. M., Davies, R. J., Moelaert, F., ... Dröes, R. M. (2007). Review of ICT-based services for identified unmet needs in people with dementia. Ageing Research Reviews, 6(3), 223–246. doi:10.1016/j.arr.2007.07.002 PMID:17869590 Libin, A., & Cohen-Mansfield, J. (2004). Therapeutic robocat for nursing home residents with dementia: Preliminary inquiry. American Journal of Alzheimer’s Disease and Other Dementias, 19(2), 111–116. doi:10.1177/153331750401900209 PMID:15106392 Macdonald, A., & Cooper, B. (2007). Long-term care and dementia services: An impending crisis. Age and Ageing, 36(1), 16–22. doi:10.1093/ageing/afl126 PMID:17175565 Magnusson, L., Hanson, E., & Borg, M. (2004). A literature review study of information and communication technology as a support for frail older people living at home and their family carers. Technology and Disability, 16(4), 223–235. Marshall, M. (Ed.). (2000). ASTRID: A Social & Technological Response to Meeting the Needs of Individuals with Dementia and their Carers. London: Hawker Publications. Marziali, E., & Garcia, L. J. (2011). Dementia Caregivers’ Responses to 2 Internet-Based Intervention Programs. American Journal of Alzheimer’s Disease and Other Dementias, 26(1), 36–43. doi:10.1177/1533317510387586 PMID:21282276 Miskelly, F. (2004). A novel system of electronic tagging in patients with dementia and wandering. Age and Ageing, 33(3), 304–306. doi:10.1093/ageing/afh084 PMID:15082438

55

 Assistive Technologies and the Carers of People With Dementia

Miskelly, F. (2005). Electronic tracking of patients with dementia and wandering using mobile phone technology. Age and Ageing, 34(5), 497–499. doi:10.1093/ageing/afi145 PMID:16107453 Mittelman, M. S., Brodaty, H., Wallen, A. S., & Burns, A. (2008). A Three-Country Randomized Controlled Trial of a Psychosocial Intervention for Caregivers Combined With Pharmacological Treatment for Patients With Alzheimer Disease: Effects on Caregiver Depression. American Journal of Geriatric Psychiatry, 16(11), 893-904. Doi:810.1097/JGP.1090b1013e3181898095 Mittelman, M. S., Roth, D. L., Clay, O. J., & Haley, W. E. (2007). Preserving Health of Alzheimer Caregivers: Impact of a Spouse Caregiver Intervention. American Journal of Geriatric Psychiatry, 15(9), 780-789 doi:710.1097/JGP.1090b1013e31805d31858a Moise, P., Schwarzinger, M., & Um, M.-Y., & the Dementia Experts’ Group. (2004). Dementia care in 9 OECD countries: a comparative analysis (Working Papers No 13). OECD Health. Retrieved from http:// www.oecd.org/els/health-systems/33661491.pdf Newbronner, L., Chamberlain, R., Borthwick, R., Baxter, M., & Glendinning, C. (2013). A Road Less Rocky – Supporting Carers of People with Dementia. Retrieved from http://www.carers.org/sites/default/ files/dementia_executive_summary_english_only_final_use_this_one.pdf NICE/ SCIE. (2007). Dementia. A NICE–SCIE Guideline on supporting people with dementia and their carers in health and social care. Retrieved from http://www.nice.org.uk/nicemedia/live/10998/30320/30320. pdf Nygård, L., & Johansson, M. (2001). The experience and management of temporality in five cases of dementia. Scandinavian Journal of Occupational Therapy, 8(2), 85–95. doi:10.1080/110381201300173621 Census 2011. Who we are. How we live. What we do. (n. d.). Office for National Statistics. Retrieved from http://www.ons.gov.uk/ons/guide-method/census/2011/index.html?utm_ source=LCRNNewsService&utm_campaign=2da3bf9763-LCRN_Resource_eNews_Volume_2_ Issue_42_10_2011&utm_medium=email Orpwood, R., Adlam, T., Evans, N., Chadd, J., & Self, D. (2008). Evaluation of an assistedliving smart home for someone with dementia. Journal of Assistive Technologies, 2(2), 13–21. doi:10.1108/17549450200800014 Orpwood, R., Bjørneby, S., Hagen, I., Mäki, O., Faulkner, R., & Topo, P. (2004). User Involvement in Dementia Product Development. Dementia (London), 3(3), 263–279. doi:10.1177/1471301204045160 Orpwood, R., Chadd, J., Howcroft, D., Sixsmith, A., Torrington, J., Gibson, G., & Chalfont, G. (2008). User-led Design of Technology to Improve Quality of Life for People with Dementia. In P. Langdon, J. Clarkson, & P. Robinson (Eds.), Designing Inclusive Futures (pp. 185–195). Springer London. doi:10.1007/978-1-84800-211-1_18 Peck, E., Gulliver, P., & Towel, D. (2002). Information, consultation or control: User involvement in mental health services in England at the turn of the century. Journal of Mental Health (Abingdon, England), 11(4), 441–451.

56

 Assistive Technologies and the Carers of People With Dementia

Powell, J., Chiu, T., & Eysenbach, G. (2008). A systematic review of networked technologies supporting carers of people with dementia. Journal of Telemedicine and Telecare, 14(3), 154–156. doi:10.1258/ jtt.2008.003018 PMID:18430288 Prensky, M. (2001). Digital Natives, Digital Immigrants Retrieved from http://www.marcprensky.com/ writing/Prensky-DigitalNatives,Digital Immigrants-Part1.pdf Quadrello, T., Hurme, H., Menzinger, J., Smith, P. K., Veisson, M., Vidal, S., & Westerback, S. (2005). Grandparents use of new communication technologies in a European perspective. European Journal of Ageing, 2(3), 200–207. doi:10.100710433-005-0004-y Rasquin, S. M. C., Willems, C., de Vlieger, S., Geers, R. P. J., & Soede, M. (2007). The use of technical devices to support outdoor mobility of dementia patients. Technology and Disability, 19(2), 113–120. Robinson, L., Brittain, K., Lindsay, S., Jackson, D., & Olivier, P. (2009). Keeping in Touch Everyday (KITE) project: Developing assistive technologies with people with dementia and their carers to promote independence. International Psychogeriatrics, 21(3), 494–502. doi:10.1017/S1041610209008448 PMID:19193255 Rosenberg, L., Kottorp, A., & Nygård, L. (2012). Readiness for Technology Use with People With Dementia: The Perspectives of Significant Others. Journal of Applied Gerontology, 31(4), 510–530. doi:10.1177/0733464810396873 Savva, G. M., Zaccai, J., Matthews, F. E., Davidson, J. E., McKeith, I., & Brayne, C. (2009). Prevalence, correlates and course of behavioural and psychological symptoms of dementia in the population. The British Journal of Psychiatry, 194(3), 212–219. doi:10.1192/bjp.bp.108.049619 PMID:19252147 Schneider, J., Murray, J., Banerjee, S., & Mann, A. (1999). EUROCARE: a cross-national study of co-resident spouse carers for people with Alzheimer’s disease: I—factors associated with carer burden. International Journal of Geriatric Psychiatry, 14(8), 651–661. doi:10.1002/(SICI)10991166(199908)14:83.0.CO;2-B PMID:10489656 Shibata, T., & Wada, K. (2011). Robot Therapy: A New Approach for Mental Healthcare of the Elderly – A Mini-Review. Gerontology, 57(4), 378–386. doi:10.1159/000319015 PMID:20639620 Spruytte, N., Van Audenhove, C., & Lammertyn, F. (2001). Predictors of institutionalization of cognitively-impaired elderly cared for by their relatives. International Journal of Geriatric Psychiatry, 16(12), 1119–1128. doi:10.1002/gps.484 PMID:11748770 Tadd, W., Hillman, A., Calnan, S., Calnan, M., Bayer, T., & Read, S. (2011). Dignity in Practice: An exploration of the care of older adults in acute NHS Trusts Retrieved from http://www.bgs.org.uk/ pdf_cms/reference/Tadd_Dignity_in_Practice.pdf Tamura, T., Yonemitsu, S., Itoh, A., Oikawa, D., Kawakami, A., Higashi, Y., ... Nakajima, K. (2004). Is an Entertainment Robot Useful in the Care of Elderly People With Severe Dementia? The Journals of Gerontology. Series A, Biological Sciences and Medical Sciences, 59(1), M83–M85. doi:10.1093/ gerona/59.1.M83 PMID:14718491

57

 Assistive Technologies and the Carers of People With Dementia

The NHS Information Centre Social Care Team. (2010). Survey of Carers in Households 2009/10 Retrieved from http://www.hscic.gov.uk/catalogue/PUB02200/surv-care-hous-eng-2009-2010-rep1.pdf Topo, P. (2008). Technology Studies to Meet the Needs of People with Dementia and Their Caregivers: A Literature Review. Journal of Applied Gerontology, 28(1), 5–37. doi:10.1177/0733464808324019 Topo, P., Saarikalle, K., Begley, E., Cahill, S., Holthe, T., & Macijauskiene, J. (2007). “I don’t know about the past or the future, but today it’s Friday” – Evaluation of a time aid for people with dementia. Technology and Disability, 19(2), 121–131. Upton, D., Upton, P., Jones, T., Jutlla, K., & Brooker, D. (2011). Evaluation of the impact of touch screen technology on people with dementia and their carers within care home settings. University of Worcester. Wahl, H.-W., Iwarsson, S., & Oswald, F. (2012). Aging Well and the Environment: Toward an Integrative Model and Research Agenda for the Future. The Gerontologist, 52(3), 306–316. doi:10.1093/geront/ gnr154 PMID:22419248 Wey, S. (2006). One size does not fit all: person-centred approaches to the use of assistive technology. In M. Marshall (Ed.), Perspectives on Rehabilitation and Dementia (pp. 202-208). London: Jessica Kingsley Publishers. White, E. B., & Montgomery, P. (2014). Electronic tracking for people with dementia: An exploratory study of the ethical issues experienced by carers in making decisions about usage. Dementia (London), 13(2), 216–232. doi:10.1177/1471301212460445 PMID:24599815 Woolham, J., Gibson, G., & Clarke, P. (2006). Assistive technology, telecare and dementia: Some implications of current policies and guidance. Research Policy and Planning, 24(3), 149–164.

This research was previously published in the International Journal of Reliable and Quality E-Healthcare (IJRQEH), 5(1); edited by Anastasius Moumtzoglou, pages 45-59, copyright year 2016 by IGI Publishing (an imprint of IGI Global).

58

59

Chapter 4

Visual Communication to Improve Relationship Quality in Spousal Caregivers of Individuals With Alzheimer’s Disease Nola Freeman Magnolia Community Services, USA

ABSTRACT The study investigated the effectiveness of an art therapy intervention in improving relationship quality of spousal caregivers and their spouses with Alzheimer’s Disease (AD). Two single case studies were conducted, each composed of a caregiver and spouse with AD. Intervention consisted of three art therapy sessions based on visual communication, or the mutual creation of artwork. Relationship quality was measured throughout the study using clinical notes, pretest and posttest, and caregiver daily reports of positive interactions with their spouse. Couple dynamics were found to influence how positively each art therapy directive was viewed; however, both caregivers noted valuing art therapy interventions for providing recreation and socialization. The intervention resulted in increased positive interactions in both case studies.

INTRODUCTION Alzheimer’s Disease (AD) is a progressive illness characterized by gradual cognitive decline (American Psychiatric Association, 2000). As the disease progresses, individuals with AD often lose a sense of their pre-illness identity along with memories of loved ones (Reisberg & Franssen, 1999). The individual with AD eventually requires fulltime care. Caregivers of those with AD often find that they have taken on a fulltime job that is both physically and emotionally challenging. Caregivers frequently experienced a decrease in wellbeing due to the demanding nature of the job (Ott, Sanders, & Kelber, 2007). Dealing with cognitive, functional, and DOI: 10.4018/978-1-5225-7122-3.ch004

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

behavioral issues with the individual with AD was found to lead to higher levels of “depression, poor health habits, physiological dysregulation, psychiatric or medical morbity, and mortality than noncaregivers” (Vitaliano, Zhang, Young, Caswell, Scanlan, Echeverria, 2009). It was found that caregivers of individuals with AD were six times more likely to have an onset of dementia (Norton, Smith, Ostbye, et al., 2010). By the later stages of the disease, it was found that caregivers struggled to view the individual with AD as continuous with their previous identity due to vast changes in memory and behavior in their loved one (Chesla, Martinson, & Muwaswes, 1994). As a result, caregivers may struggle to stay emotionally connected to a relationship that has transformed so dramatically. Caregivers struggling to stay connected emotionally were found more likely to discontinue providing care (Hirschfeld, 1983). If not cared for within the family, individuals with AD received care provided in nursing homes or in mental health hospitals (Ernst & Hays, 1991). While the majority of homecare costs fall on caregivers, the costs of institutionalization are paid most often by the public through programs such as Medicare/ Medicaid (Mebane-Sims, 2009). With the number of individuals diagnosed with AD expected to grow rapidly, the annual rate of diagnosis expected to triple by 2047, providing additional supports for caregivers in the home is not only advantageous for the wellbeing of caregivers but also for the costs of society at large (Brookmayer et al., 1998). The present study investigated whether art therapy could be used to provide support to caregivers of spouses with AD. It was hypothesized that couple’s art therapy, in which caregivers and spouses with AD worked together to create art, would strengthen a couple’s relationship quality. An art therapy intervention was formulated by considering the current literature on the caregiving relationship and the use of art therapy with caregivers and individuals with AD.

THE CAREGIVING RELATIONSHIP Relationships with individuals with AD were found to fall within three categories: continuous, continuous but transformed, or radically discontinuous (Chesla, Martinson, & Muwaswes, 1994). In continuous relationships, individuals with AD were seen as representing the same identity throughout the disease. The relationship was perceived as unchanged, and patterns of behavior were seen as continuous with past behaviors. If relationships were continuous but transformed, the individual was perceived as transformed by the disease; however, the caregiver was still dedicated to maintaining their relationship. Those with a radically discontinuous relationship saw the individual as discontinuous from the person they once knew. Those in discontinuous relationships became emotionally detached and were most likely to discontinue providing care, or continued to provide care at a lower quality (Williamson & Schaffer, 2001). Although many caregivers come to view the individual with AD as separate from their previous identities, one study found it was possible with intervention to aid the caregiver in forming a new perspective (Quayhagan & Quayhagan, 1996). Exercises for the caregiver and spouse with AD were provided to increase positive interaction through a variety of games aimed at increasing memory. Caregivers in the study came to view their spouse as more congruent with their past identity after the exercises revealed their spouse’s dormant abilities, which resulted in greater relationship satisfaction. Relationships quality was further delineated by the level of mutuality in the caregiving relationship (Hirchfeld, 1983). Mutuality was defined as having “ability to find gratification in the relationship with the impaired person and meaning in the caregiving situation… and the caregiver’s ability to perceive 60

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

the impaired person as reciprocating by virtue of his/her existence” (p. 26). Higher levels of mutuality, or higher levels of meaning from perceived reciprocation by the spouse, were found to result in lower levels of caregiver strain (Archbold, Stewart, Greenlick, & Harvath, 1990). Lack of meaningful interaction with a spouse with AD, along with overall activity restriction, was found to be a primary complaint of spousal caregivers (Williamson & Schulz, 1993; Williamson, Shaffer, & Schulz, 1998). Limited positive interaction was found to negatively affect the spouse’s feeling about their relationship. In considering current literature, caregiver needs in terms of intervention included: a greater ability to view their spouse as continuous with their previous identity, a greater ability to perceive their spouse as reciprocating in the relationship, and increased positive interaction with their spouse.

ART THERAPY INTERVENTION Wadeson (1972) described aspects of couple’s art making which were said to be advantageous for improving a relationship. Important aspects included immediacy, genuineness, permanence, and shared pleasure. For individuals with AD, communication using traditional verbal and written language was found to be challenging. However, they maintained the ability to communicate nonverbally far longer than their ability to communicate through words (Ally, Gold, & Budson, 2009; Groves-Wright, NellsStrunjas, Burnett, and O’Neill, 2004, p. 110). Those with AD had the ability to express their visual preferences, and preferences for certain visual images were stable over time (Halpern, Ly, Elkin-Frankston, & O’Connor, 2008). Since individuals with AD were found to remember images longer than words, visual communication could provide a meaningful link to the inner world of a spouse and their identity before disease progression. Additionally, art-making was found to be beneficial emotionally and behaviorally for individuals with AD. An increase in sensory stimulation provided by art-making was found to calm individuals while at the same time increased “memory and cognitive ability, and increase verbalization” (Trudeau, 1999; Witucki & Twibell, 1997, p. 10). Creating artwork was found to be calming for the individual with AD by reminding the individual of past pleasant memories recorded in artwork (Stewart, 2004). Bloomgarden and Sezaki (2000) found that visual communication encouraged positive interaction by re-opening lines of communication between a caregiver and spouse previously challenged by disease progression. Visual communication in the study focused on interaction between a caregiver and spouse with AD through the creation of artwork. In the study, visual communication was established via the couple alternating making marks on a piece of paper and responding to each other’s visual marks. Art in the study was soothing for both individuals and allowed the couple an alternate form of communication. The visual communication intervention, called the “squiggle game,” was originally created by Donald Winnicott (1974). The squiggle game involved one individual making a mark, and the other individual responding to that mark. Couples either worked to make an image with their marks or simply responded visually without worrying about image creation (Eisdell, 2005). The directive was said by Winnicott (1974) to allow each individual to assert their own identity equally through creating a mark on paper to represent their identity. By responding to each other’s marks, a couple was said by Winnicott to come together to form a visual relationship. Art therapy intervention based on visual communication was presented in the current literature as increasing positive interactions from increased connection to past identity and reciprocation in the relationship. It was hypothesized that an art intervention based on visual communication could potentially 61

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

provide an increased relationship quality by increasing the number of positive interactions between caregiver and spouse. The presented study investigated the effectiveness of an art therapy intervention based on visual communication in improving the relationship of spousal caregivers and individuals with AD.

METHOD Two single case studies were conducted to examine the effectiveness of an art therapy intervention, based on visual communication, in increasing relationship quality in caregivers and spouses with AD.

Participants Participants for the study included two couples, each consisting of an individual in the mild to moderate stages of AD and their spousal caregiver. Participants were referred for participation by a local private organization that provides services for caregivers of individuals with AD. Participants were in their seventies and both couples were Caucasian. Case one was composed of a lesbian couple, while couple two was identified as heterosexual. The caregiver was female in both cases. Art therapy sessions took place in home-based settings.

Measures Caregivers were asked to complete the “Mutuality Scale of the Family Care Inventory” (Archbold et al., 1990) as a pretest and posttest. The pretest was used to measure the couple’s relationship quality before intervention. The test was found to be reliable, with Cronbach’ alphas at .90 to .95, when used with elderly caregiver populations. “Evidence for construct validity of the Mutuality Scale was supported by regression results” (Crist, Escandon, Stewart, & Archbold, 2008, p. 287). Caregivers were provided a booklet containing forms to complete daily throughout the study to record the number of positive interactions with their spouse, and were given the option to provide a written description of the positive interaction that stood out most in their memory from each day. Quantitative data for the study included scores from the Mutuality Inventory and recorded number of positive interactions. Qualitative data included case notes, artwork, and descriptions of positive interactions as recorded by the caregiver.

Procedure Couples participated in a total of five meetings, each occurring approximately one week apart. In the first meeting, caregivers were provided logs of positive interactions to complete and the pretest was conducted. After a baseline of caregiver reported positive interactions was established during the first week, couples participated in a total of three art therapy sessions. Both couples participated in three home-based art therapy sessions, each lasting approximately 30 minutes. All three art therapy sessions used directives that followed the “conversational model” of art therapy, focusing on visual interaction between the couple (Eisdell, 2005). In the first session, couples participated in a scribble chase directive which was based on Winnicott’s (1974) squibble game. In the scribble chase directive, couples were directed to take turns making scribbles using colored markers. The caregiver 62

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

was directed to make a scribble on the paper, and the spouse was asked to follow the caregiver’s marks. The couple was next directed to switch roles, with the spouse as the leader and caregiver as follower. The couple was then asked to work together to create an image from the scribbles. In the next session, the couple created salt dough together and took turns adding and mixing ingredients to create the dough. The couple was asked to take turns creating forms from the dough. In the third session, the couple was provided two sets of fine art postcards. The caregiver first held up each image from a stack of cards and the spouse was asked to choose which cards were preferred from the stack. The couple then alternated, with the individual with AD holding up cards from which the caregiver could choose. The couple then worked together to select images they both preferred from the chosen cards and to create a final collage as a couple. A week following the final art therapy intervention, the fifth meeting, the caregiver was asked to again complete the Mutuality Scale of the Family Care Inventory as a posttest and the data analyzed to form a conclusion.

RESULTS Two couples participated in a research study investigating the use of art therapy to increase the quality of the relationship between spousal caregivers and individuals with AD. Couple one was composed of a lesbian couple in their early seventies, while couple two was composed of a heterosexual couple in their late seventies. Caregivers were asked to complete a pretest and posttest and were asked to record the number and quality of positive interactions with their spouse daily. Additionally, qualitative data was gathered in the form of descriptions of positive interactions, along with researcher notes of interactions. Findings from the two cases were compared to inform a conclusion as to whether art therapy, based on a conversational model, would increase the quality of the relationship between caregiver and spouse with AD.

Case 1 Couple one was composed of a couple identifying as lesbian, with the caregiver being referred to as “M,” while the individual with AD being referred to as “L.” L was 74 years old, Caucasian, and was officially diagnosed with AD at 72 years of age. M was 71 years old. The couple participated in five meetings over a five week period, three of which included art therapy sessions.

Qualitative Data Qualitative data for couple one included case notes and artwork along with descriptions of positive interactions recorded by the caregiver.

Meeting 1 In the first meeting, the couple discussed jokingly how at times they became frustrated with one another. The caregiver noted that the couple’s activities had been limited by disease progression to those not requiring direct interaction such as watching television and taking walks. 63

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

Meeting 2 The second meeting began with L becoming frustrated with M for discussing L’s new dentures. However, once the couple began the scribble chase directive, the couple was able to interact positively. L first had difficulty asserting her opinion in the form of choosing a marker color and followed M tentatively in the scribble chase. But when it became L’s turn as the leader in the scribble chase, she excitedly took the lead and scribbled as quickly as possible. L’s speed was evident in the scribble chase, the drawing showing many twists and turns (Figure 1). L spelled the word “revenge” aloud as she drew, and M explained that L was seeking revenge by drawing quickly for having to follow M’s lead so often in daily life. By creating images from the scribble drawings, the couple took different drawing approaches. L’s drawings were composed of single lines, while M worked in filling or shading between the lines. Through the art directives, it appeared that L was able to reclaim a leadership role in the relationship, and M was happy to take a following position.

Meeting 3 In the third meeting, the couple worked together to make salt dough. As the couple kneaded the dough, M recounted how her mother used to make bread frequently and L discussed how they had a housekeeper help in making bread for her family. When it was L’s turn to form the dough, she forcefully pounded it over and over again in her hands. M recounted an earlier disagreement about L losing a purse that M believed held her checkbook inside. The couple began the session in disagreement. The tension from the event was evident as L pounded the clay, while M made images of stingrays, a phallus, and a volcano to express her frustration. Using the clay, the couple was able to express their frustrations in a nonthreatening way. The couple was also able to share memories of bread-making. By the end of the session, the couple was able to work together and compromised to make a rabbit, often symbolizing fertility, from the volcano form as a sign of coming together as a couple after a disagreement (Figure 2). Figure 1. Scribble chase drawing with L as leader

64

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

Figure 2. L and M’s collaborative rabbit using salt dough

Meeting 4 The fourth week similarly began with the couple in disagreement. L was persuaded to interact with her spouse through the promise of creating artwork. The couple created collages using fine art images. During the intervention, M became aware that it was easier for L to assert her dislikes more than her likes when choosing images for the collage. M chose Van Gogh images because she knew L liked Van Gogh, and L confirmed that she liked the images. The art process allowed M to visually express that pleasing L was important to her. L was able to verify M’s ability as caregiver and partner by choosing images she preferred. Additionally, L showing a preference for Van Gogh revealed to M that L had preferences that were unchanged by disease progression. By the end of the session, the couple worked together to create a collage with the couple’s preferences equally represented in the final collage.

Meeting 5 During the final meeting, M completed the final mutuality inventory as a posttest. M noted her favorite intervention was the scribble chase directive and fine art collage because they allowed L to take more of a leadership role, instead of her telling L what to do all the time. M noted she did not like the salt dough activity as much because it felt strange in her hands.

Descriptions of Positive Interactions The caregiver additionally provided descriptions of the positive interaction most prominent in her memory each day. Major themes of positive interactions from caregiver descriptions, summarized in

65

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

Table 1, included cooperation, participating in the community, appreciation for each other, and enjoying recreational activities. Days when the caregiver did not provide a written description of a positive interaction were denoted using the (--) symbol in Table 1. The most mentioned positive interactions were in the areas of community participation followed by interactions around recreation and appreciation. The least mentioned was cooperation, which was often mentioned with surprise in the first week. After the first art therapy intervention, M noted greater in paying more attention to L, resulting in more logs with themes of appreciation. Additionally by the final week, M no longer noted surprise when L was cooperative.

Quantitative Data Quantitative Data for couple one included pretest and posttest numerical scores, along with numerical reports of positive interactions completed daily by the caregiver during the study.

Pretest and Posttest The Mutuality Scale of the Family Care Inventory (Archbold et al., 1990) was used to measure changes in the caregiver’s perception about the quality of the relationship with the spouse with AD before and after intervention. Lower scores on the mutuality inventory reflected lower levels of relationship quality. The calculated score on the pre-test was 1.467. The final inventory was given and collected in the final meeting in week five with the couple. The posttest score was 2.067. The caregiver’s mean score over fifteen questions increased by 0.600. Over fifteen questions, no score decreased from the pretest to posttest.

Numerical Log of Positive Interactions During the five week study, caregiver M completed daily logs of positive interactions to record the number of positive interactions with her spouse. Numerical logs of positive interactions are presented graphically in Figure 3. The baseline (A) and intervention (B) period were divided within the graph by a dark black line on day nine. During the baseline period, the mean of positive interactions was 0.62. Table 1. Case I log of positive interactions categorized by theme   Week I

  Week II and III

  1. Cooperation   2. Recreation   3. --  4. --  5. Appreciation   6. --  7. Cooperation   8. ---

  9. Recreation   10. Appreciation   11. Community, Recreation   12. Recreation   13. Appreciation   14. Appreciation   15. Cooperation   16. Community   17. Community, Recreation   18. Community   19. Community   20. Recreation   21. --  22. Community

66

  Week IV

  23. Recreation   24. Appreciation   25. Community, Appreciation   26. Appreciation   27. --  28. Recreation   29. Community

  Week V

  30. Recreation   31. Appreciation   32. Community   33. Recreation   34. Community   35. Community   36. Community

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

Figure 3. Graph of daily positive interactions

During the intervention, the mean of positive interactions was 1.81. The mean values for the baseline and intervention periods are summarized in Table 2. Trend lines (Figure 4), comparing the baseline (A) and intervention periods (B), revealed a negative trend in the number of positive interactions throughout time. However, the negative slope of the trend line was greater during the baseline period. The slope during the baseline period was -0.0595, while the slope during the intervention period was -0.011. The greatest change from the baseline to intervention Table 2. Case I mean values of baseline and intervention periods Baseline (A)

Intervention 1

Intervention 2

Invervention 3

Total Intervention (B)

0.62

1.71

1.53

2.00

1.81

Figure 4. Trend lines of baseline and intervention periods

67

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

period was the level of positive interactions. While the baseline period began around the level of one positive interaction daily, the intervention period began around the level of two positive interactions. Through visual inspection and examination of the means across baseline and intervention periods, it is apparent that the number of positive interaction increased over the course of the study. By visualizing the trend line during the baseline period as extending through the intervention phase, it was found that 100 percent of intervention data points fell above the baseline trend. Therefore it can be said, using the split-middle method, that there was positive change in positive interactions during the intervention phase Significance was found using the relative frequency technique. Fifteen intervention period data points were found to fall above the typical range of the baseline (Figure 5). The positive change in the intervention period was found to be significant (p ≤ 0.05), using the Table of the Cumulative Binomial Probability Distribution (Behling & Merves, 1984).

Case 1 Summary During week one, the caregiver reported the least amount of positive interactions, and M noted surprise when L was cooperative. However, after the first intervention, there was a large increase in the number of positive interactions, and M voiced less surprise at cooperation by L. Each art therapy intervention actively ended disagreements occurring before sessions by neutralizing conflicts through visual expression. Overall, there was an increase in positive interactions. Interventions were found to be effective in increasing cooperation by allowing the individual with AD to take a greater leadership role, resulting in more equality during interactions.

Case 2 Couple two was composed of a caregiver and spouse with AD identifying as heterosexual. The caregiver was referred to as “N,” and the partner with AD was referred to as “B.” The individual with AD was age 79 and was officially diagnosed with AD at age 72. The spousal caregiver was age 76 at the time of the Figure 5. Relative Frequency from baseline to intervention period

68

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

study. The caregiver noted she was hard of hearing and that B had essential tremors. N explained that the essential tremors were caused by a nerve disorder causing shaking, especially in the hands. N noted that B had surgery to implant a stimulating device in the brain, which decreased his tremors dramatically.

Meeting 1 In the first meeting, N noted that interactions with her spouse had been limited by disease progression to less physically active activities such as sitting side by side and watching television, however still enjoyed each other’s company. During the meeting, N was a dominant presence in the relationship and carried the conversation.

Meeting 2 In the second meeting, the couple participated in a scribble chase directive. After creating scribbles, N said it looked like a winding mountain road and discussed how they used to visit their family in the mountains. The couple created another scribble, and B said he saw “cow titties.” N explained that B’s parents used to have a dairy farm. The art directive appeared to have stimulated reflection on memories. In following artwork, B continued on his motif of the “cow titty.” N became frustrated and began drawing smiley faces. When she became frustrated, she also would direct B in what to draw. Overall, the couple’s marks were separate and did not interact (Figure 6). Interaction occurred only with B mimicking N’s marks.

Meeting 3 During the third meeting, the couple worked together to make salt dough. N said she used to bake a lot making biscuits. N drew a flower and made grass using food coloring on her half of the dough. B used Figure 6. N and B collaborative drawing

69

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

the green gel and mimicked the grass on N’s dough to make a wreath-like design. He said it could be called the “green, green grass of home.” Both individuals were able to reminisce about the past in the directive. It was again evident that B had greater ease in following N’s lead in making art. The couple continued to make forms with the dough. N said she wanted it to be yellow, but said she knew that green would dominate, since it was B’s favorite color. As a result, B was able to have a moment of dominance with the color green showcased, which resulted in N accepting the colored expression. B formed the green dough into a coil shape and said it was a hot dog or a “cow titty.” N again became frustrated and added a smiley face (Figure 7).

Meeting 4 During the fourth meeting, the couple began the fine art card collage. N first held up the fine art cards for B without looking at the images and became frustrated when he slowly chose images he preferred. B indicated to her when they were upside down, and N began to look at the images. When asked which image he liked the best, he said the Mona Lisa because it reminded him of the Virgin Mary. N chose an image of a farmer and wife, representing herself and B, because they previously enjoyed gardening. When creating a collaborative collage, each individual placed their cards on their side of the paper. N’s chosen cards were pictured on the right side of the paper, with B’s on the left. N commented that she knew B would choose the ink painting of a tree and showed enjoyment when B chose a card she predicted he would like. N said they would get a frame for the image and put it between their recliners, showing an increased investment in the art.

Meeting 5 During the fifth meeting, B was experiencing health difficulties and was on the way to a doctor’s office; therefore, the meeting was postponed for five days. At the continuation of meeting five, N informed that B’s visit to the hospital had resulted in receiving a pacemaker. Figure 7. B and N’s finished collaborative salt dough creation

70

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

N said the least enjoyable directive was the first scribble chase, directive because it was not aesthetically pleasing. She said she enjoyed the final directive using fine art cards. The art card directive provided the most structure, allowing N more control of the final piece. B noted he enjoyed the art card directive, and pointed to the image of “Mona Lisa.” B similarly chose the Mona Lisa as his most preferred art card during the art directive, confirming that the artwork was able to provide a record of B’s preferences.

Positive Interaction Summary Positive interactions were characterized primarily as having company (Company), B enjoying recreational activities (Recreation), and B’s ability to remember (Memory). Table 3 summarizes themes of positive interactions from the study. N had difficulty recording the number of positive interactions daily, noting the couple does the “same ‘ole thing” every day. Therefore, the data from the logs was solely descriptive and did not include a quantitative element. Interactions involving memory were most frequently described negatively. Interactions involving recreation and company were more frequently characterized positively. During the first week, logs were negative in tone (-) and focused on B’s difficulty with memory. After the first intervention, logged interactions became positive and focused on activities and people that B enjoyed visiting. Additionally, N noted enjoying the researcher’s company and fun in making art. In the final week, B began to have health difficulties which affected his memory and increased negativity in logs of positive interactions.

Pretest and Posttest The caregiver was asked to complete The Mutuality Scale of the Family Care Inventory (Archbold et al., 1990) to measure changes in the caregiver’s perception about the quality of the relationship with the spouse with AD before and after intervention. Lower scores on the mutuality inventory reflected lower levels of mutuality and lower relationship quality. The calculated score on the pretest was 3.20. The final inventory was given and collected at the final meeting with the couple. The posttest score was 3.47. The caregiver’s mean score over fifteen questions increased by 0.27. No score decreased over fifteen questions from the pretest to posttest.

Case 2 Summary Art therapy increased positive interaction in the case two relationship. There was a slight increase in the pretest and posttest measuring the quality of the relationship. It was found that the caregiver viewed positive interactions as revolving around memory, recreation, and company. Table 3. Case II log of positive interactions categorized by theme Days 1-6 1. Memory (-) 2. Memory (-) 3. Recreation (-) 4. --5. --6. ---

Days 7-10 7. Recreation, Memory 8. Recreation, Memory 9. Company 10. Company

Days 11-15 11. Recreation, Company 12. Memory, Company 13. Memory (-) 14. Recreation 15. ---

Days 16-18 16. Company 17. Recreation, Memory (-) 18. Memory (-)

71

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

Art therapy sessions were characterized as providing recreation and company. The fine art card directive was viewed as most positive due to aesthetic evaluation, yet the directive also resulted in the least amount of “visual conversation.” The scribble chase was viewed as least preferred due to the abstract nature of the directive and evidence during the directive of B’s neurological difficulties.

COUPLE 1 AND 2 JOINT ANALYSIS Two single case studies were performed using art therapy based on a conversational model. A joint analysis was conducted to compare the results of the two studies.

Meetings The couples participated in three art therapy interventions based on a conversational model. Both couples found the directives beneficial in reflecting on past memories. It was found that both couples preferred art directives that allowed them to take their preferred relationship dynamics. Couple one preferred the scribble chase because it led to more equality in interactions. Couple two disliked the scribble chase because they preferred the caregiver to maintain the role of leader in the relationship. Couple one longed for greater equality between the two members after disease progression resulted in the caregiver taking more of a leadership role. Couple two similarly had the caregiver taking the leadership role, however, without the desire for change. Couple dynamics predicted which interactions were viewed as positive.

Pretest and Posttest Both couples showed an increase in scores on the mutuality inventory from pretest to posttest, showing increased relationship quality. However, significance from pre to posttest was not able to be calculated due to small sample size. Couple two began with a higher level of mutuality than couple one. Couple two may have started with greater mutuality due to their acceptance of their current interaction style with N as leader. However, from pretest to posttest, couple one had a greater increase of 0.60 compared to the increase of 0.26 in couple two.

Positive Interactions Quantitative results from case one revealed a significant increase in positive interactions from the baseline to intervention period for the first couple. Couple two lacked quantitative data recording positive interactions and therefore could not be used in comparison. Both couples primarily identified positive interactions as those including recreation and community. The caregiver from couple one described events as positive that involved cooperation and appreciation from her spouse, but frequently voiced surprise at her wife’s cooperation and appreciation in her descriptions. The caregiver from couple two saw interactions as positive in which her spouse’s memory was functioning. In the baseline period, the caregiver from the second couple voiced surprise when her spouse was able to remember.

72

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

Summary Couple one valued interventions increasing equality in interactions by allowing the individual with AD to take more leadership. Couple one viewed positive interactions as those increasing cooperation and appreciation, but noted to be lacking in these areas. Couple two saw positive interventions as those in which the caregiver could maintain a leadership position. Couple two viewed positive interactions as those in which the individual with AD was able to show the ability to remember but noted frustration when an ability to remember was lacking. Both couples recorded recreation and community involvement as their most frequently viewed positive interactions. Art-making based on visual communication was found to allow couple one to gain greater equality, leading to greater cooperation and appreciation. In couple two, art was found to aid in reflection of past memories and revealed a stability of preference for images over time in the individual with AD. In both couples, art was viewed as a recreational and social activity. As a result, art therapy increased positive interaction and therefore increased the quality of relationships between caregivers and spouses in both couples.

DISCUSSION Overall, the intervention was found to foster positive interactions in couples by providing valuable recreational and social activity for couples. As a result, art therapy based on the conversational model would be an effective tool to use with couples lacking in recreational and social interaction due to disease progression which may aid in decreasing caregiver burden. Additionally, art therapy intervention based on visual communication was found to increase equality in interactions. It was found that in case one, the couple fit a continuous pattern of interaction and therefore searched for their partner’s identity in making art. Case two most closely fit the category of continuous yet transformed. The caregiver cared for her spouse, yet saw him as totally transformed from his prior identity. For this reason, the caregiver in case two had a decreased desire to search out her husband’s identity in creating art because she was convinced the identity was lessening with disease progression. Any evidence of disease progression in the form of difficulty with memory was painful for the caregiver because it signaled she was further losing her husband’s prior identity to the disease. It was found that caregivers and spouses valuing a continuous relationship, which focused on equality in interactions, were more likely to view interactions based on the conversational model as positive. Although the caregiver in case one had at times begun to view the partner as transformed by disease progression, the intervention was able to reinforce her partner’s ability to interact equally. Those in continuous but transformed relationships valued interactions where separateness in interaction, or parallel play, could be maintained. The individual in case two, although in a similar stage of AD, had lower functioning due to essential tremors. For the caregiver, a greater equality in art-making revealed disease progression through repeated motifs and slow interaction by her spouse. For couples in transformed relationships due to disease progression, interventions allowing the couple to maintain their current interaction style would most likely allow for greater perceived positive interaction. However, those in transformed relationships with higher functioning in earlier stages of the disease may benefit more from visual communication and equality in interaction. For such couples, early intervention would be of importance. 73

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

Overall, findings from the current study were in line with findings by Bloomgarden and Sezaki (2000). Bloomgarden and Sezaki found that art therapy based on a conversational model was beneficial for caregiver and individuals with AD. Intervention based on visual communication provided a valuable social and recreation interaction and allowed couples to reflect on past memories, regardless of the couple’s relationship type.

CONCLUSION A study was conducted involving two single case studies to investigate the effectiveness of an art therapy intervention, based on the visual communication, in improving the quality of the relationship between spousal caregivers and individuals with AD. The quality of the relationship was measured by the number and quality of positive interactions of the couples throughout the study. Additionally, couples were given a pretest and posttest to further investigate changes in the quality of their relationships. It was found an art therapy intervention, based on visual communication, increased positive interactions in the two couples. Positive interactions were defined by caregivers as interactions involving recreation and socialization. It was also found that couple dynamics influenced which interventions were viewed as positive. Individuals in continuous relationships were found to value interventions that increased equality, while those in continuous but transformed relationship valued those which separateness could be maintained.

REFERENCES Ally, B., Gold, C., & Budson, A. (2009). The picture superiority effect in patients with Alzheimer’s disease and mild cognitive impairment. Neuropsychologia, 47(2), 595–598. doi:10.1016/j.neuropsychologia.2008.10.010 PMID:18992266 American Psychiatric Association. (2000). Diagnostic and statistical manual of mental disorders (4th ed., text rev.). Washington, DC: Author. Archbold, P. G., Stewart, B. J., Greenlick, M. R., & Harvath, T. (1990). Mutuality and preparedness as predictors of caregiver role strain. Research in Nursing & Health, 13, 375–384. doi:10.1002/ nur.4770130605 PMID:2270302 Behling, J. H., & Merves, E. S. (1984). The practice of clinical research: The single case method. London, UK: University Press of America, Inc. Bloomgarden, J., & Sezaki, S. (2000). Home-based art therapy for older adults. Art Therapy: Journal of the American Art Therapy Association, 17(4), 283–290. doi:10.1080/07421656.2000.10129756 Brookmayer, R., Gray, S., & Kawas, C. (1998). Projections of Alzheimer’s disease in the United States and the public health impact of delaying disease onset. American Journal of Public Health, 88, 1337–1342. doi:10.2105/AJPH.88.9.1337 PMID:9736873 Chesla, C., Martinson, I., & Muwaswes, M. (1994). Continuities and discontinuities in family members’ relationship with Alzheimer’s patients. Family Relations, 43, 3–9. doi:10.2307/585135

74

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

Crist, E. (2008). Stewart. Archbold. Eisdell, N. (2005). A conversational model of art therapy. Psychology and Psychotherapy: Theory. Research and Practice, 78(1), 1–19. Ernst, R. L., & Hays, J. W. (1994). The US economic and social costs of Alzheimer’s Disease revisited. American Journal of Public Health, 84(8), 1261–1264. doi:10.2105/AJPH.84.8.1261 PMID:8059882 Groves-Wright, K., Nells-Strunjas, J., Burnett, R., & O’Neill, M. (2004). A comparison of verbal and written language in Alzheimer’s disease. Journal of Communication Disorders, 37(2), 109–130. doi:10.1016/j.jcomdis.2003.08.004 PMID:15013729 Halpern, A., Ly, J., Elkin-Frankston, S., & O’Connor, M. (2008). “I know what I like”: Stability of aesthetic preference in Alzheimer’s patients. Brain and Cognition, 66, 65–72. doi:10.1016/j.bandc.2007.05.008 PMID:17606318 Hirschfeld, M. (1983). Homecare versus institutionalization: Family caregiving and senile brain disease. International Journal of Nursing Studies, 20(1), 23–32. doi:10.1016/0020-7489(83)90036-6 PMID:6552227 Mebane-Sims, I. (2009). 2009 Alzheimer’s disease facts and figures. Alzheimer’s and Dementia: The Journal of the American Alzheimer’s Association, 5(3), 234–270. Norton, M. C., Smith, K. R., Østbye, T., Tschanz, J. T., Corcoran, C., & Schwartz, S., … The Cache County Investigators. (2010). Greater risk of dementia when spouse has dementia? The cache county study. Journal of the American Geriatrics Society, 58(5), 895–900. doi:10.1111/j.1532-5415.2010.02806.x PMID:20722820 Ott, C. H., Sanders, S., & Kelber, S. T. (2007). Grief and personal growth experience of spouses and adult-child caregivers of individuals with Alzheimer’s disease and related dementias. The Gerontologist, 47(6), 798–809. doi:10.1093/geront/47.6.798 PMID:18192633 Quayhagen, M., & Quayhagen, M. (1996). Discovering life quality in coping with dementia. Western Journal of Nursing Research, 18(2), 120–135. doi:10.1177/019394599601800202 PMID:8638419 Reisberg, B., & Franssen, E. H. (1999). In M. J. de Leon (Ed.), Clinical stages of Alzheimer’s disease (pp. 11–20). New York, NY: Parthenon Publishing Group. Stewart, E. (2004). Art therapy and Neuroscience blend: Working with patients who have dementia. Art Therapy: Journal of the American Art Therapy Association, 21(3), 148–155. doi:10.1080/07421656.2 004.10129499 Trudeau, S. (1999). Bright eyes, a sensory stimulation intervention for patients with advanced dementia. Innovations in End-of-Life Care. Retrieved from http://www2.edc.org/lastacts/archives/archivesJune99/ featureinn1.asp Vitaliano, P., Zhang, J., Young, H., Caswell, L., Scanlan, J., & Echeverria, D. (2009). Depressed mood mediates decline in cognitive processing speed in caregivers. The Gerontologist, 49(1), 12–22. doi:10.1093/ geront/gnp004 PMID:19363000

75

 Visual Communication to Improve Relationship Quality in Spousal Caregivers

Wadeson, H. (1972). Conjoint marital art therapy techniques. Psychiatry, 35, 89–98. PMID:5061230 Williamson, G. M., & Schulz, R. (1993). Coping with specific stressors in Alzheimer’s disease caregiving. The Gerontologist, 33(6), 747–755. doi:10.1093/geront/33.6.747 PMID:8314101 Williamson, G. M., & Shaffer, D. (2001). Relationship quality and potentially harmful behaviors by spousal caregivers: How we were then, how we are now. Psychology and Aging, 16(2), 217–226. doi:10.1037/0882-7974.16.2.217 PMID:11405310 Williamson, G. M., Shaffer, D., & Schulz, R. (1998). Activity restriction and prior relationship history as contributors to mental health outcomes among middle-aged and older spousal caregivers. Health Psychology, 17(2), 152–162. doi:10.1037/0278-6133.17.2.152 PMID:9548706 Winnicott, D. W. (1974). Therapeutic consultations in child psychiatry. London, UK: Hogarth Institute of Psycho-Analysis. Witucki, J., & Twibell, R. S. (1997). The effect of sensory stimulation activities on the psychological well-being of patients with advanced Alzheimer’s disease. American Journal of Alzheimer’s Disease and Other Dementias, 12(1), 10–15. doi:10.1177/153331759701200103

This research was previously published in the International Journal of User-Driven Healthcare (IJUDH), 3(3); edited by Ashok Kumar Biswas, pages 96-111, copyright year 2013 by IGI Publishing (an imprint of IGI Global).

76

77

Chapter 5

Preventing Alzheimer’s Wandering:

The Potential of Involving Communities Sara Paiva Instituto Politécnico de Viana do Castelo, Portugal Rui Peleja Instituto Politécnico de Viana do Castelo, Portugal Jorge Cunha Instituto Politécnico de Viana do Castelo, Portugal Carlos Abreu Instituto Politécnico de Viana do Castelo, Portugal

ABSTRACT With increased life expectancy, the incidence of age-related cognitive impairments, faced by the elderly and older generations, is growing. Among the population with cognitive impairments, those that suffer from Alzheimer’s disease are the most common. The Alzheimer’s disease is a chronic degenerative brain disorder that is characterised by a failure of memory and, in some instances, by disorders in language, perception and planning. As a consequence of the progressive damages imposed by the illness, patients will increasingly seek and need assistance. This paper presents a tool to aid the development and managing of caregiving communities, comprising immediate family members, relatives, neighbours and healthcare professionals, to assist patients with Alzheimer’s disease. Such communities could have a strong impact on the quality of care provided to the patients. At the same time, it is hoped that involving communities will significantly improve the quality of life of Alzheimer’s patients and their families while reducing the costs related to the care provided.

DOI: 10.4018/978-1-5225-7122-3.ch005

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Preventing Alzheimer’s Wandering

INTRODUCTION Nowadays, concerns over the safety and well-being of the elderly are becoming overwhelming. Currently, in developed countries with a growing population of the elderly, the question of how to take good care of those who are aging has started to arise as the son-and-daughter generation for these love ones appears to lack the time needed to provide the needed assistance for their parents. In this context, and to reinforce this growing trend, Dara-Abrams (2008) refers to the field of Gerontechnology, developed in the late 1980s, as a field aiming to aid the elderly by combining gerontology with new technologies. As stated in Fozard (2005), many such technologies are emerging in several domains, including health and self-esteem, housing and daily living, mobility and transport, communication and governance, work and leisure. As the need to help the elderly increases, an awareness of how they can be helped become something needing our attention. Accordingly, Graafmans and Taipale (1998) defined the Gerontechnology’s Five Ways, which are essentially the five key approaches to assist the elderly in their daily lives, namely the way of prevention, enhancement, compensation, care, and research. For each of these Five Ways, Dara-Abrams defined some tasks and associated applications. For instance, for prevention, she defines tasks such as monitor, intervene or teach health habits. As for associated applications, she mentions falls prevention, nutrition or strengthening training. Here, our emphasis is on prevention of the adverse effects of the Alzheimer’s disease on those who tend to suffer from it, namely, on tracking of the elderly as well as the use of caregiving communities to generate a collaborative help. With the constantly growing elderly population in modern societies, it is not surprising that a large group of the elderly will have or be affected with some kind of dementia. Of all dementia diseases, the Alzheimer Disease (AD) is the most common (Alzheimer’s Association, 2012), which explains the focus of our study falling upon those elderly people plagued by this disease. The same association states that AD is caused by various diseases and conditions that result in damaged brain cells or connections between brain cells. They also point out ten key aspects that are symptoms and signs of AD: memory loss that disrupts daily life; challenges in planning or solving problems; difficulty completing familiar tasks at home, at work or at leisure; confusion with time or place; trouble understanding visual images and spatial relationships; new problems with words in speaking and/or writing; misplacing things and losing the ability to retrace steps; decreased or poor judgment; withdrawal from work or social activities; and finally, changes in mood and personality. Some of these aspects are particularly important because of the potential dangerous consequences they may have such as getting injured or even killed. As stated by Michael and McNamee (2006), dementia becomes a very serious issue when an Alzheimer´s patient (AP) starts to “wander”. Considering the prevalence (ie., existing cases) and incidence (ie., appearance of new cases) of AD, The consequences of the AD are becoming more significant. According to the Alzheimer’s Association (2012) 5.4 million Americans of all ages are estimated to have AD in 2012. Amongst the people aged 65 or older, one in eight will have AD. In fact, the incidence is increasing dramatically with age, starting with 53 new cases per 1,000 people aged 65 to 74 and going up to 231 new cases per 1,000 people over age 85. Showing the growing impact of this disease and the urge to ease its consequences is the fact that currently one American will develop AD every 68 seconds, and by the mid-century, the 68 seconds will be reduced to only 33 seconds. A detriment issue relating to AD has to do with the costs of the care provided. The Alzheimer Association, in its 2012 report (Alzheimer’s Association, 2012) states that over 15 million Americans provide unpaid care for a person with Alzheimer’s or other dementia and that care can be provided not 78

 Preventing Alzheimer’s Wandering

only primarily by family members, but also by other relatives and friends. Apparently, given the high costs of taking care of someone with Alzheimer´s, which many families simply cannot afford, unpaid cares are sometimes thought to be necessary. In contrast, examples of paid services include adult day centre services (around $70 per day), assisted living ($41,724 per year) or nursing home care ($79,110 to $87,235 per year). Thus, help and collaboration among all of the community people is therefore a precious contribution to both patients and caregivers. Why this contribution may be critical is the fact that around 15% of the caregivers live more than 1 and/or 2 hours from the person with AD. Therefore, having the extra help closer to the AP can free the caregiver of some worries. Involving the people with dementia in the community can aid them in maintaining their dignity and reduce the existent stigma (Hogg & Watt, 2012). Driven by this idea and the necessity of helping APs and their caregivers, with the involvement of communities, this paper presents a GPS tracking system specifically oriented for APs with a strong focus on the involvement of caregiving communities to act upon and to prevent wandering APs. In this way, the security of APs as well as the well-being of caregivers can also be safeguarded. Involving the community also has the advantage of avoiding the need to force the AP to stay home, leading to his isolation and accelerating the AD and the consequent need to institutionalize the AP. In fact, according to Hogg and Watt (2012), isolation is felt by 40% of people with dementia for two main reasons. One is keeping them at home without companionship from family and/or friends; the other is preventing them to take walks and permitting them to socialize with other people because of the risks associated. The rest of this paper is organized as follows: in the next section, we review the extant literature on generic and Alzheimer-specific tracking and monitoring systems as well as the community involvement in these kinds of systems. Section 3 highlights the involvement to be expected from the caregiving communities and the main benefits to be gained from such collaborative helps. Section 4 outlines our proposed GPS tracking system with the community involvement, starting with a general overview to be followed by an explanation of the main components of the GPS architecture., After this, we present the experiments performed to validate our proposal. Finally, we conclude with some observations and directions for future work.

BACKGROUND Over the years, several monitoring and GPS-tracking system to assist APs have emerged in several domains. One of these domains is home monitoring where the main purpose is to guarantee the safety of the elderly during the time they are alone at home (Jian, Kiong, & Heng, 2010; Abreu, Teixeira, & Fonseca, 2007; Gaddam, Mukhopadhyay, & Gupta, 2011; Yan, Huo, Xu, & Gidlund, 2010) (McCullagh, Carswell, & Augusto, 2009). Other proposals are specific to a given part of the house such as the bedroom (Schikhof & Mulder, 2008) or the bathroom (Chen, Kam, Zhang, Liu, & Shue, 2005). Other applications focus on monitoring the health condition of the elderly users such as in (Arcelus, Jones, Goubran, & Knoefel, 2007; Shamsi, Ahmed, & Redha, 2011; Wood et al., 2006; Wtorek et al., 2010). As previously discussed, one of the main challenging conditions of the AD is confusion with time or place (Alzheimer’s Association, 2012). This justifies the focus on monitoring people outside their houses as dangerous situations may arise if APs forget where they are or how much time has passed since they left home. Some have proposed aiding wandering APs using either GPS (Shoval et al., 2008) or RFID technology (Miura, Ito, Takatsuka, & Kunifuji, 2010; Makimoto et al., 2008). In 2000, Deborah Altus 79

 Preventing Alzheimer’s Wandering

and her colleagues presented an outdoor monitoring system that relies on a transmitter worn by the AP and a portable receiver used to search for the patient (Altus, Mathews, Xaverius, Engelman, & Nolan, 2000). They developed the Mobile Locater, which provides the caregivers with a tool to locate a lost person. A noted potential drawback of this solution was the high cost involved. Another outdoor system for achieving the same purpose is ComfortZone (Alzheimer´s Association, 2013) as presented by the Alzheimer Association. This system relies on a GPS device that sends location position to the ComfortZone Web application accessible to AP caregivers. The monitoring level can be configured differently such as to determine the type of alerts received. Other generic outdoor monitoring systems exist such as 3DTracking (3DTracking, 2013), GpsGate Server (GpsGate, 2013), GPS-Trace Orange (Orange, 2013) or OpenGTS (OpenGTS, 2013). Regarding the community involvement, and according to the Alzheimer´s Association, close relatives are the most common type of AP caregivers. The same association claims that around 50% of AP caregivers live in the same house as the patient; 50% take care of parents and between 6% to 17% take care of the spouse. Beyond these facts, some case studies are being developed worldwide to gather information and experience about how to help people who wander. Some examples are presented in Beattie, McCrow, Kearns, and Applegarth (2009) where the authors explained the background, methods, results and conclusions of each study. Relevant information of those studies shows that beyond the common involvement of local authorities in helping people with dementia, others include nurses, allied health care professionals and family carers of the patient. Another case is described in Lachenmayr, Goldman, and Brand (2000) where the creation of a community base for police officers to help AP return home safely is emphasized. The idea of extending community helps for people with AD beyond just local authorities includes the solicitation of volunteer caregivers. Volunteer caregivers are trusted people known to the family who may have some availability and are close to the AP as well. Therefore, these volunteers can provide a proximity accompaniment to the AP. Several other advantages can be described: assigning an increased number of available caregivers to a given APs will improve safety; effectively, the AP will have a wider range of places where s/he can walk around and still being watched. Such commitments will definitely increase the quality of life of primary caregivers who feel more confident about the well-being of the AP.

THE COMMUNITY’S INVOLVEMENT AND COLLABORATIVE HELP As aforementioned, AD is a neurodegenerative disorder characterized by a progressive loss of memory and eventually by disorders in language, perception, orientation, behaviour, and planning. The damages imposed by the AD on its patients will gradually affect their daily lives, and ultimately, position them to become fully dependent on a caregiver. This has a devastating impact on public health and on society as a whole. Considering the high level of cognitive disorders and functional dependence of the APs, and the growing incidence of the disease, it is evident that to minimise the economic burden of the AD, the entire community inclusive of family members, relatives, friends, neighbours, health care professionals as well as local authorities may have to collaborate in such a way as to organize themselves to improve the health and well-being of both APs and their caregivers. The involvement of family members on the AP’s health and well-being is of major importance. As noted, almost 80% of unpaid care delivered at home in the US is provided by family members. Due to the high level of AP’s dependence, many family caregivers experience high levels of emotional stress and, in 80

 Preventing Alzheimer’s Wandering

the some cases, depression. Furthermore, caregiving may also have a negative impact on employment, income and family finances. Caregiving of people with AD is very challenging and time consuming and often comes with potentially negative impact on the caregivers. In this sense, the involvement of broader community participation can be of great benefit towards the improvement of the AP’s health and wellbeing. Similarly, involving a community of volunteers are even more important if the AP lives alone or away from his family, thereby increasing also the quality of life of the AP caregivers. The caregiving tasks provided to the APs by their family members, relatives, friends or volunteers depend on the specific needs of these patients. These tasks can be related to different aspects of the daily living such as instrumental activities, personal activities or activities associated to patient safety. In regards to patient safety, this work advocates the use of a monitoring and tracking system that can be applied to create and manage communities of volunteers to avoid unsafe wandering and prevent losing the APs. The next section discusses the proposed GPS tracking system with the involvement of the volunteer community of caregivers.

PROPOSED GPS TRACKING SYSTEM WITH THE COMMUNITY INVOLVEMENT In this section, a tracking system designed especially for APs, with a focus on the involvement of a broader caregiving community and the use of online social networks, is presented. We will start by providing a general overview of the system, followed by a discussion of its architecture.

General Overview With the emergence of several technologies designed especially to help tracking APs, it makes sense to add to these systems the community involvement component. As aforementioned, many caregivers often live far away (one or two hours’ drive) from the APs; thus, enlisting the help of a wider caregiving community can often enhance the health and well-being of the APs. This will also free the immediate family members (i.e. the primary caregivers) from undue worries over the APs and further reduce costs to AP caregivers. As for the AP tracking technology, we advocate that the sole requirement for such a system to be the possession and use of a mobile device given the rapid proliferation of mobile equipment nowadays. The choice for this equipment should be based on its GPS functionality, its low cost and also on the possibility of developing an application that can easily provide the ability to configure the system’s usage. By carrying a mobile device, the AP has a way to be monitored as information on the tracking of the position can be acquired through GPS satellites and sent to a Web-based application. Caregivers, healthcare professionals or members of the caregiving community can then freely access the Web-based application or receive notifications on the whereabouts of the APs either past or present via email/cellular, anytime and anywhere. An interesting aspect regarding the acceptance of these solutions was reported in Wild, Boise, Lundell, and Foucek (2008) where results of interviews conducted with people aged 65+ and immediate family members showed that the resistance on using such a technology is more likely to come from the family members rather than the APs. Privacy has always been a concern as the patient’s whereabouts and their identities should only be disclosed to legally authorized people who care about them. Privacy is, in fact, one of the four aspects defined in the Ethical Framework presented in Michael and McNamee (2006), alongside accuracy, property and accessibility aspects. 81

 Preventing Alzheimer’s Wandering

When monitoring a new patient, several actions should be performed in the system: inserting the patient information, defining and assigning the caregivers, volunteers and healthcare professionals so that they can monitor the new patient, creating alerts and specifying safe points. There are two types of safe points: specific and generic. Specific safe points are locations where monitored APs are considered to be safe or they will be able to find some type of help. These points are specific to each monitored patient, for example, the workplace of a caregiver. A perimeter is associated with each safe point so the responsibility of respective caregiver and the frequency of relevant coordinates can be determined. This flexibility allows us to have safe areas with different monitoring levels. Generic safe points are those that can be applied to every monitored AP such as the Hospital or any other health facility. Regarding alerts, these represent the preventive component of the system. The functionality of alerts should be specifically oriented to the APs. Two measures are critical in the firing of any alerts: time and position. A position alert is used to monitor patients that should not go beyond a specific perimeter. Time alerts are used when a caregiver or healthcare professional wants to know if the monitored AP left a safe area beyond a specific time. The involvement of a broader community of caregivers is achieved with the possibility of associating friends, neighbours or any other person who shows availability to help a given AP. In other words, all AP caregivers are aware of those whom the APs trust primarily, and are able to view and share the whereabouts of the APs. With this type of collaboration, and depending on the whereabouts of the AP, there may be several different people watching over the APs at any given time, thereby assuring his overall well-being and safety. In the next subsection, more details on the architecture of our proposed system are presented.

ARCHITECTURE In this section, we will illustrate the architecture of our proposed system as depicted in Figure 1. The following key components are to be included: • • • • •

The actors, who are the aps, their caregivers (family and volunteers) and/or healthcare professionals; A web server where the Web Platform is hosted, namely the Back-Office and Front-Office; A web service invoked by the mobile application to send location data; A mobile application that sends information on tracked coordinates; A central database that keeps configurations and locations.

The Actors Two types of actors are critical to the adoption and subsequent success of the system: the APs and the caregivers (family and volunteers and/or healthcare professionals). Regarding the APs, the monitoring process should be transparent to the APs and should also require no active intervention from the APs. The caregivers or healthcare professionals are the ones who should configure the monitoring process. Each caregiver can monitor the APs in different ways. For instance, the healthcare professional may be interested in monitoring the patient based on time whereas the caregiver might prefer to monitor the patient based on his or her position. Additionally, they need to configure safe points, perimeters, responsible person and the frequency of monitoring. 82

 Preventing Alzheimer’s Wandering

Figure 1. Architecture of the GPS tracking solution with the community involvement showing the actors, web and data server, web service and mobile application

The Web Platform: Back-Office The Back-Office allows the system administrator, the caregivers or the healthcare professionals to configure a new AP to be monitored as well as how s/he will be monitored. All the previously mentioned users have access to the Back-Office, but with different privileges. Specifically, a generic model that allows flexible settings on the privileges of each caregiver with operations, permissions, groups and users is presented. Essentially, the model consists of defined groups who are assigned with certain permissions. Each user is placed in a given group depending on the privileges to be assigned. Beside the profile management functionalities described above, the Back-Office also provides the basic functionalities of creating and listing caregivers (users) as well as creating and listing monitored APs. As for the generic and specific safe points, their creation is made directly on a map. Alerts then act upon safe points either based on time or position. The information is to be sent through SMS, email or to a dedicated social network. Currently, the options provided are: 1) current location; 2) distance from home; 3) distance to specific safe points and 4) distance to general safe points. Two examples of messages are given below: CurrLocation: Atlantic Avenue / Home: 500m

83

 Preventing Alzheimer’s Wandering

CurrLocation: Saint Vincent Street / Home: 500m / Daughter’s Work: 3000m / Hospital: 1200m The first message shows only the current location and the distance from home whereas the second provides all the tracked information. Typically, a caregiver or healthcare professional would configure detailed information to be sent by email and shorter information through SMS so the costs are controlled.

The Web Platform: Front-Office The main purpose of the Front-Office is to allow caregivers or healthcare professionals to monitor the APs. The interface shows specific safe points associated to the monitored patient, general safe points as well as the location of the AP. Restrictions over time are provided so it becomes easier to analyse where the monitored patient has been.

The Web Service The web service has a simple functionality so it becomes possible to send the current coordinates to the server. The service is developed in PHP and basically receives two strings: one referring to the latitude and another to the longitude. The network traffic associated to the invocation of this service is the only cost; hence, the AP must have a mobile device plan that covers for data services.

Mobile Application The mobile application has a background service that sends GPS coordinates and local time to the Web Platform. In order to do that, update information needs to be captured by the mobile application at all times regarding if the current location belongs to a safe area. As well, information on the monitoring frequency of that area is often needed so the system can decide whether to send the coordinates to the server. For this reason, the mobile application needs to have current information regarding the safe points and their configuration. These operating principles are illustrated in the right side of Figure 2. On the left side of the same Figure, the architecture is presented. The most relevant components are the Communication Manager, the Configuration Manager and the GPS Driver. The Communication Manager is responsible for performing all type of communications either by using SMS, Wi-Fi, or GPRS. The Configuration Manager is responsible for processing the configuration file received from the server. Finally, the GPS driver is responsible for every work related to location identification.

EXPERIMENT AND EVALUATION Next, we present the most relevant experiments used to validate the proposed system. First, we conducted experiments related to tracking and monitoring of APs with the correspondent information sent to the central database and made available in the Web Platform. The second experiment had to do with sending position alerts when the monitored AP goes out of a safe perimeter and time alerts when the monitored AP stays out of a safe area longer than configured. Finally, the third experiment had to do with the involvement of community caregivers and how safe areas were configured to make use of volunteered helps. 84

 Preventing Alzheimer’s Wandering

Figure 2. Architecture and operating principles of the mobile application

Experiment 1: Tracking and Monitoring By carrying the mobile device with him, the patient´s position is monitored according to the configured frequency. Its position is sent to a central server where a Web Platform is hosted and can be accessed by all assigned caregivers. In that Web Platform, they can see information such as the general and specific points associated to the monitored patient and, more important, his past and current location. Figure 3 shows some of this information regarding one of the monitored APs participating in the experiments (from left to right): a view of the current location and some general and specific safe points; a zoomed-in view of the previous scenario, and finally, the last known locations of the monitored AP.

Experiment 2: Alerts As aforementioned, our system allows two types of alerts: position and time alerts. Figure 3. Web platform information showing the current and last known location of the patient and also some general and specific safe points

85

 Preventing Alzheimer’s Wandering

A position alert is used to monitor the AP to ensure that s/he should not be going beyond a specific perimeter. To test this functionality, the following experiment was performed (see Figure 4): a specific safe point was defined at the home of the monitored AP with a range of 150 meters and with “caregiver A” being the responsible and assigned person tracking the AP; another safe point which corresponds to the daughter´s home (“caregiver B” - daughter´s workplace) was defined 200 meters from the AP’s house (“orange spot”). In a first experimental walk, the monitored AP goes out the safe perimeter of his “orange spot,” which causes a position alert to be fired to “caregiver A”. Additionally, an alert can also be sent to a close generic safe area, such as a Hospital or Police Station. In a second walk, the monitored person leaves the safe perimeter of his home but enters another one (daughter´s workplace). In this case, as the caregiver responsible for monitoring the new area is different from the area the monitored person left, the new responsible (“caregiver B”) was notified by SMS as this was the way the system was configured. Another option would be not to send any notification as the monitored person remains in a safe area. As for time alerts, they are used when a caregiver or healthcare professional wants to know if the monitored patient left a safe area more than “x” minutes ago. For this purpose, a time of 10 minutes was defined as it corresponds to the safe and usual time the monitored person is out for a walk. The monitored AP left his “orange spot” (home) and after 15 minutes was still out of the safe perimeter - this resulted in a SMS being sent to “caregiver A”. We experimented with the same walk, but this time it was faster and occurred at the end of the time allowed when the monitored AP was either inside the safe perimeter or even already at home. In these two situations no alert was fired.

Experiment 3: Community Involvement Regarding the involvement of a broader community of caregivers, we believe that the main potential has to do with the participation of volunteers and associated organization(s). In our experiments, three retired and healthy neighbours, who were trusted by the patient’s family, were involved. Again, a safe point was defined in the AP´s home within a range of 150 meters. As this AP likes to go to the park which happens to be outside the safe perimeter of his home, two different neighbours who Figure 4. Scenarios used for test purposes of time and position alerts

86

 Preventing Alzheimer’s Wandering

volunteered to watch over him when he goes to the park were enlisted as community caregivers given that they also spend a lot of their own time at the same park. Another neighbour volunteered to watch him if he heads the opposite directions from his home. In the first scenario, the patient left home to go to the park. The two neighbours were notified by SMS and both went to find him so as to provide him a close accompaniment. In the second scenario, when the monitored person left home in the opposite direction of the park, the third volunteer was also notified to assist him in that area. These scenarios show how the wider community of caregivers, specifically, the volunteered neighbours, can be involved in helping the APs to prevent them from wandering. With their collaboration, APs can be under a bigger surveillance contributing to their safety and well-being to the relief of their primary caregivers.

CONCLUSION The Alzheimer’s disease is a degenerative brain disorder that is characterized by a failure of several cognitive functions, for example, loss of memory and perception, confusion, behaviour changes and disorientation. These failures result in cognitive and functional impairments that will strongly affect the patient’s ability to perform daily activities. In this paper, a collaborative tool to track Alzheimer patients preventing unsafe wandering was presented. Unlike the usual GPS-tracking system, caregiving communities support the proposed system. These communities, comprising family members, relatives, neighbours and health care professionals, play an important role to improve the quality of care provided to Alzheimer patients and significantly increase the quality of life of family caregivers. The system was tested and the performed experiences confirmed its utility and ability to provide effective care to Alzheimer patients. Moreover, the system proves to be very useful to create and to manage the caregiving communities as well as to reduce the costs related with the care provided by the families to Alzheimer’s patients. As for future work, the system will be tested with a larger set of patients involving larger communities of caregivers and official authorities. In such a scenario, the social and economic impact of the proposed system will be more evident.

REFERENCES Abreu, C., Teixeira, A., & Fonseca, J. (2007). Speech enabled interface to home automation for disabled or elderly people. In Proceedings of the International conference for Software Development for Enhancing Accessibility and Fighting Infoexclusion (DSAI 2007) (pp. 59–63). Altus, D. E., Mathews, R. M., Xaverius, P. K., Engelman, K. K., & Nolan, B. A. D. (2000). Evaluating an electronic monitoring system for people who wander. American Journal of Alzheimer’s Disease and Other Dementias, 15(2), 121–125. doi:10.1177/153331750001500201 Arcelus, A., Jones, M. H., Goubran, R., & Knoefel, F. (2007). Integration of smart home technologies in a health monitoring system for the elderly. In Proceedings of the 21st International Conference on Advanced Information Networking and Applications Workshops (AINAW’07) (Vol. 2, pp. 820–825). IEEE.

87

 Preventing Alzheimer’s Wandering

Association, A. (2012). 2012 Alzheimer’s disease facts and figures. Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association, 8(2), 131–168. doi:10.1016/j.jalz.2012.02.001 PMID:22404854 Association, Alzheimer’s. (2012). 2012 Alzheimer’s disease facts and figures. Alzheimer’s & Dementia. Retrieved from http://scholar.google.com/scholar?hl=en&btnG=Search&q=intitle:Alzheimer’s+Disea se+Facts+and+Figures#0 Association, Alzheimer’s. (2013). Comfort zone. Retrieved January 2, 2013, from www.alz.org/comfortzone Beattie, E., McCrow, J., Kearns, W., & Applegarth, S. (2009). Australian National Dementia Research Forum 2009 Abstracts. Alzheimer’s & Dementia, 5(5), 10. doi:10.1016/j.jalz.2009.07.005 PMID:19118804 Chen, J., Kam, A., Zhang, J., Liu, N., & Shue, L. (2005). Bathroom activity monitoring based on sound. Pervasive Computing, 3468, 65–76. Dara-Abrams, B. (2008). Toward a model for collaborative gerontechnology: Connecting Elders and their caregivers. In Proceedings of the Sixth International Conference on Creating, Connecting and Collaborating through. Computing, C5, 109–114. 3. DTracking. (2013). 3DTrack. Retrieved January 7, 2013, from http://3dtracking.com.pt/ Fozard, J. L. (2005). Gerontechnology: Optimizing relationships between aging people and changing technology. Contemporary issues in gerontology: Promoting positive aging (pp. 241–268). Sydney, Australia: I.C. Couls. Gaddam, A., Mukhopadhyay, S. C., & Gupta, G. S. (2011). Trial and experimentation of a smart home monitoring system for elderly. Instrumentation and Measurement Technology Conference (I2MTC), 2011 IEEE (pp. 1–6). GpsGate. (2013). GpsGate server. Retrieved January 20, 2013, from http://gpsgate.com/ Graafmans, J., & Taipale, V. (1998). Gerontechnology. A sustainable investment in the future. Studies in Health Technology and Informatics, 48, 3–6. PMID:10186534 Hogg, L., & Watt, A. (2012). Overcoming the stigma of dementia World Alzheimer Report 2012. Jian, Y., Kiong, T. K., & Heng, L. T. (2010). Development of an e-Guardian for the single elderly or the chronically-ill patients. In Proceedings of the International Conference on Communications and Mobile Computing. Lachenmayr, S., Goldman, K. D., & Brand, F. S. (2000). Safe return: A community-based initiative between police officers and the Alzheimer’s Association to increase the safety of people with Alzheimer’s Disease. Health Promotion (Oxford, England), 268–278. Retrieved from http://hpp.sagepub.com/content/1/3/268.short Makimoto, K., Eun Ah Lee, Kang, Y., Yamakawa, M., Ashida, N., & Kyung Rim Shin. (2008). Temporal patterns of movements in institutionalized elderly with dementia during 12 consecutive days of observation in Seoul, Korea. American Journal of Alzheimer’s Disease and Other Dementias, 23(2), 200–206. doi:10.1177/1533317507312625 PMID:18184949

88

 Preventing Alzheimer’s Wandering

McCullagh, P., Carswell, W., & Augusto, J. (2009). State of the art on night-time care of people with dementia. In Proceedings of the IET Conference on Assisted Living (p. 6). Michael, K., & McNamee, A. (2006). The emerging ethics of humancentric GPS tracking and monitoring (pp. 25–27). Mobile Business. Miura, M., Ito, S., Takatsuka, R., & Kunifuji, S. (2010). Aware group home enhanced by RFID technology. KnowledgeBased Intelligent Information and Engineering Systems (Vol. 5178/2008, pp. 847–854). Springer. OpenGTS. (2013). Open GPS tracking system. Retrieved January 20, 2013, from http://www.opengts.org/ Orange, G.-T. (2013). Gps-trace orange. Retrieved January 2, 2013, from http://gps-trace.com Schikhof, Y., & Mulder, I. (2008). Under watch and ward at night: Design and evaluation of a remote monitoring system for dementia care. In A. Holzinger, (Ed.), HCI and Usability for Education and Work, 5298, 475–486. Shamsi, H. A., Ahmed, S., & Redha, F. (2011). Monitoring device for elders in UAE. In Proceedings of the 2011 International Conference and Workshop on Current Trends in Information Technology (CTIT) (pp. 32–36). IEEE. Shoval, N., Auslander, G. K., Freytag, T., Landau, R., Oswald, F., Seidl, U., & ... (2008). The use of advanced tracking technologies for the analysis of mobility in Alzheimer’s disease and related cognitive diseases. BMC Geriatrics, 8, 7. doi:10.1186/1471-2318-8-7 PMID:18366748 Wild, K., Boise, L., Lundell, J., & Foucek, A. (2008). Unobtrusive in-home monitoring of cognitive and physical health: Reactions and perceptions of older adults. Journal of Applied Gerontology, 27(2), 181–200. doi:10.1177/0733464807311435 PMID:19165352 Wood, A., Virone, G., Doan, T., Cao, Q., Selavo, L., Wu, Y., et al. (2006). ALARM-NET: Wireless sensor networks for assisted-living and residential monitoring. Technical Report CS-2006-11, Department of Computer Science, University of Virginia. Wtorek, J., Bujnowski, A., Lewandowska, M., Ruminski, J., Polinski, A., & Kaczmarek, M. (2010). Evaluation of physiological and physical activity by means of a wireless multi-sensor. In Proceedings of the 2010 2nd International Conference on Information Technology (ICIT) (pp. 239–242). Yan, H., Huo, H., Xu, Y., & Gidlund, M. (2010). Wireless sensor network based E-health system? Implementation and experimental results. IEEE Transactions on Consumer Electronics, 56(4), 2288–2295. doi:10.1109/TCE.2010.5681102

This research was previously published in the International Journal of Healthcare Information Systems and Informatics (IJHISI), 8(4); edited by Joseph Tan, pages 32-43, copyright year 2013 by IGI Publishing (an imprint of IGI Global).

89

90

Chapter 6

Integrated eCare in Dementia: The Irish Experience in the INDEPENDENT Project Sarah Delaney Work Research Centre, Ireland

ABSTRACT This chapter describes the evaluation of the INDEPENDENT project as it was implemented in Ireland. The project in Ireland consisted of the collaboration of the Alzheimer Society of Ireland, a not-for-profit organization providing services for people with dementia and their family carers, and Tunstall Emergency Response (TER), a commercial telecare provider organization. A joint client database was developed that provided information on alerts and events generated by the telecare system to ASI staff. An evaluation was undertaken with family carers, staff, and key stakeholders in ASI and TER. The telecare packages were given a high satisfaction rating by family carers. The Web portal was seen as beneficial by staff, in that it provided close-to-real time access to information on telecare alerts and events that could enhance care planning. However, staff regarded the portal as difficult to navigate and use. Key informants in ASI and TER both viewed the Web portal as enhancing the reputation of their organization.

INTRODUCTION Telecare and Dementia Dementia has been defined as ‘…an acquired and persistent impairment of intellectual faculties, affecting several cognitive domains, that is sufficiently severe to impair competence in daily living, occupation or social interaction’ (Grabowski & Damasio, 1997). It is estimated that approximately 42,000 people in Ireland are likely to have dementia (Cahill, O’Shea & Pierce, 2012). There are an estimated 50,000 carers in Ireland looking after someone with one of six specified symptoms of dementia (O’Shea, 2000; O’Shea, 2007).

DOI: 10.4018/978-1-5225-7122-3.ch006

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Integrated eCare in Dementia

Current health and social policy in Ireland is to provide support so that people with dementia can live in their own homes for as long as possible (Jones, 2004) and many people with dementia want to live at home and manage daily tasks themselves. Family carers are essential in facilitating someone with dementia to stay in their own home. In this context, the aim of telecare is to support people with dementia and their family carers in living at home, safely and securely, for as long as possible. Telecare involves the installation of sensors in the home in order to monitor and detect risk situations with a view to facilitating the independence and safety of the person with dementia, as well as providing reassurance for the informal carer. The sensors are linked to a monitoring centre that alerts the relevant parties (for example, informal carers or emergency services) when a risk situation is detected, who then make the appropriate response (for example call to the house to check on the person). Sensors may include those that monitor environmental risks (such as fire or flooding) as well as for movement and activity detection (for example, leaving the house at inappropriate times, or relevant patterns of movement/activity within the home). In some cases, alerts may be sent directly to the carer via a pager or as an SMS to a mobile phone.

The INDEPENDENT Project in Ireland The INDEPENDENT project in Ireland consisted of the collaboration of the Alzheimer Society of Ireland (ASI), a not-for-profit organization providing services for people with dementia and their family carers, and Tunstall Emergency Response (TER), a commercial telecare provider organization. Before the INDEPENDENT project, communication between these two organizations was restricted to occasional provision by TER of paper reports on telecare events to ASI Service Managers and Care Co-ordinators. The INDEPENDENT project enabled close-to-real-time provision of client-related information on patterns of telecare events. Figure 1 summarizes the service delivery process in the INDEPENDENT Figure 1. Illustration of the localized pilot implementation in Dublin

91

 Integrated eCare in Dementia

project in Ireland. Clients of the ASI receive regular home support by a care assistant employed by the ASI on the basis of a personalized care plan overseen by an ASI Care Co-ordinator. They also received a core telecare package consisting of a base unit connected to the landline phone, a smoke detector, a carbon monoxide sensor, a property exit sensor, a flood detector, bath and sink magiplugs (a magiplug is a plug that opens when the water over it reaches a certain level) and a temperature extremes sensor. Additional devices could be added to this core package if necessary. The monitoring and management of responses to alerts triggered by the telecare system was provided by TER. The INDEPENDENT infrastructure enabled TER call centre staff to document all the information and actions associated with an incoming call in a joint client database. ASI Care Co-ordinators could access the joint database via a login to a dedicated server (referred to as a web portal in the rest of this chapter), providing patterns of alerts and events over time. This information was used to review and update personal care plans in response to changing client needs. The information was also used as a new source of evidence when advising family members about the proactive management of significant risky events (‘red flag’ events), such as the person with dementia leaving the home at inappropriate times.

EVALUATING THE INDEPENDENT PROJECT IN IRELAND: APPROACH AND METHODS Aims and Objectives of the Evaluation The evaluation of the INDEPENDENT project in Ireland had three aims. The first was to study the impact of a package of telecare in conjunction with the joint database to facilitate information sharing and communication between ASI and TER on people with dementia and their family carers. The second aim was to assess the impact of telecare and the web portal on the staff of both ASI and TER, and the third was to assess the impact of telecare and the web portal at organizational level in both ASI and TER. The specific objectives were: • • • •

To assess the satisfaction of family carers of people with dementia with the telecare package they received. To assess the satisfaction of staff in ASI and TER with the telecare and the web portal. To obtain information on patterns of usage of the telecare packages and the web portal. To explore the perspectives of key organizational stakeholders on the telecare packages and the web portal.

Evaluation Approach Evaluation of telecare, telehealth and integrated care inventions is best served by multi-perspective and multi-method approaches (Barlow et al, 2006; Finch et al, 2003; Fortin et al, 2004; Heathfield et al, 1998), and this approach was applied in the evaluation of the INDEPENDENT project in Ireland. The evaluation approach involved multi-stakeholder perspectives and data gathering, including end users, service provider staff, and organizational perspectives. Triangulation was used to cross-reference data from the different sources in order to maximize the reliability and robustness of the conclusions drawn from the evaluation. 92

 Integrated eCare in Dementia

Baseline assessment was conducted with people with dementia and their family carers. Follow-up was conducted at six months. It had been originally planned to conduct a second follow-up at 12 months, but due to high rates of attrition (due to entry into long term care or mortality) it was decided not to have a second follow-up point. Access to people with dementia and their family carers was negotiated through the ASI. People with dementia were included in the evaluation if they had a diagnosis of dementia, had a main identified family carer (residing within or outside the home of the person with dementia), if they were living in the home or in a supported independent living facility and if they were a client of ASI. People with dementia were excluded from the evaluation if they did not have a main identified family carer or if they were residing in an institutional care setting. The capacity of people with dementia to give informed consent to the research was assessed using a functional assessment of capacity according to the criteria set out by the UK Mental Capacity Code of Practice. Using this approach, three people were assessed as having capacity at baseline. Only one of these three people retained capacity at six months. For this reason, the analysis presented in this Chapter is based on family carer, staff and key organizational stakeholder feedback only. Family carers provided proxy assessment of the person they care for as well as their own assessment of satisfaction. Data collection took the form of one-to-one structured interviews. Thirty dyads (consisting of one person with dementia and one family carer) were evaluated as part of the INDEPENDENT project as implemented in Ireland. At six months follow-up, 12 dyads had dropped out due to mortality or entry into long term residential care. It should be noted that while the direct evaluation was conducted with 30 dyads at baseline and 18 dyads at six months, all clients of the ASI who received telecare during the project were part of the INDEPENDENT web portal service. The total number of clients who received telecare was 153. The satisfaction survey was conducted with 22 family carers. This included four cases in which the person with dementia had recently entered long-term care, and the satisfaction questionnaire was administered retrospectively. ASI and ERL staff and key informants were interviewed at one year. Data collection took the form of focus groups with staff, and one focus group interview and one one-to-one interview with key organizational stakeholders. Logged data were collected on telecare event and alert data, and usage of the portal.

RESULTS The Impact of the INDEPENDENT Project on People with Dementia and Family Carers Based on earlier experiences of ASI in day-to-day provision of home care, a reduction in levels of carer burden and improvement of quality of life were identified as the main impact dimensions to be considered when it came to decision-making on further mainstreaming of the INDEPENDENT service. Levels of carer burden were assessed by means of the Zarit Burden Interview (ZBI). This instrument was developed to measure subjective burden among caregivers and focuses on the affective response of the caregiver. Only a small variation of ZBI score values could be observed across the two measurement points (figure 2), suggesting that during this time span the effects on carer burden remained low. In terms of people with dementia, quality of life was assessed by means of a measure that was specifically developed 93

 Integrated eCare in Dementia

Figure 2. Assessment of carer burden according to the Zarit Burden Interview across two measurement points

for individuals with dementia, the Quality of Life-Alzheimer’s Disease scale (QOL-AD). This is a proxy assessment of the quality of life of a person with dementia for completion by the family carer. There was no major variation of the QOL-AD scores across the two measurement points (figure 3). No significant difference in the quality of life of people with dementia as assessed by the family carer was apparent. T0: n=29, T1: n=17 Interpretation of scores: 0-21 = little or no burden, 21-40 = mild to moderate burden, 41-60 = moderate to severe burden, 61-88 = severe burden. Note that score values and interpretation represent guidelines only, as discussed in: Herbert R., Bravo G. and Preville M. (2000). Canadian J Aging 19: 494-507 T0: n=29, T1: n=018 The family carers were also asked at the end of the pilot duration for their assessment of whether the INDEPENDENT service has any positive or negative impacts for them in relation to their quality of life and well-being. As can be seen from figure 4, nine in ten respondents (91%) reported positive benefits, and 73 per cent reported major benefits. At the same time, seven in ten respondents reported no negative impacts, while three in ten (29%) reported minor negative impacts. When asked about benefits for the

94

 Integrated eCare in Dementia

Figure 3. Assessment of quality of life of the cared for persons according to average QOL-AD scores across two measurement points

person cared for, fewer respondents felt that the person with dementia had experienced positive benefits (54%). However this was balanced by the fact that 91 per cent of carers did not report any negative impacts on the cared-for person. Carers provided more detail on the nature of the positive benefits they experienced. The most important benefits emerging from the feedback received were linked to a sense of security, reassurance and peace of mind. Another benefit identified was increased independence both for the person with dementia and the family carer. These impacts are illustrated by the following statements made by family carers: Security and knowing that help is available at the touch of a button should the need ever arise. When the person with dementia is on their own, carers reassured that telecare is there, especially if the person with dementia leaves the house. Person with dementia can live on her own and independently, the carer does not have to spend nights with the person with dementia. Hopefully my wife would benefit from my greater sense of security.

95

 Integrated eCare in Dementia

The family is able to keep the person with dementia at home for longer. She [the person with dementia] can stay in her own home. Some carers commented on the nature of the negative impacts they experienced. The main issues were to do with the utilization of the equipment in the home. The door exit sensor system didn’t suit, it kept firing unnecessarily. Decided to take it out. Sometimes the person with dementia hits the red button without me knowing – surprised when TER staff respond. The family carers were also asked whether the pilot service had any impacts on specific aspects of their caring role (figure 5). The majority reported positive impacts in relation to the sense of reassurance (86%) and on their worries about the safety of the person they were caring for (82%). Almost seven in ten (68%) respondents reported a positive impact on their levels of stress experienced due to their caring role, and slightly fewer respondents (64%) said that the INDEPENDENT service had a positive impact on their caring burden and related strain. Over half (59%) of respondents reported positive impacts on their ability to help the person cared for. Figure 4. Positive and negative impacts perceived by the family carers for themselves and for the person cared for

96

 Integrated eCare in Dementia

Figure 5. Impacts of telecare on specific aspects of caring

Some family carers made suggestions for improving the pilot service in relation to the technology used. These mainly concerned a desire to enable more flexibility when it comes to installing equipment in their own home environment, as illustrated by the following statements: If we had been able to adjust the door exit settings for more flexibility...via a key pad. I would like a sensor on the front gate rather than the front door. One thing that could be done is a CCTV on the front door to allow me to see who’s outside. n=22

97

 Integrated eCare in Dementia

The majority of family carers were satisfied with the ease of use and the reliability of the technology used, and with how the equipment fitted in to their daily routines (see figure 6). More than eight in ten (86%) carers reported that they had no problems in this area. There may however be some room for improvement regarding the general appearance of the home devices used. Slightly less than half (45%) of carers said that they liked the appearance of the technology. Overall, family carers were satisfied with the pilot service (see figure 7). Almost seven in ten respondents (68%) said that they were very satisfied and 27 per cent said that they were fairly satisfied. At the same time, no respondent expressed any dissatisfaction with the INDEPENDENT service. Similarly, more than eight in ten (86%) respondents considered the effort taken to participate in the INDEPENDENT project worth it. With these high satisfaction ratings, it is perhaps not surprising that 91 per cent of respondents said they would like to continue using the system beyond the immediate pilot duration. On the other hand, one in ten (9%) of family carers said that they would not like to further use the service after the end of the pilot duration, due to the fact that the person they cared for had recently entered long term care. When asked about their satisfaction with the way that the pilot project was implemented, more than nine in ten (95%) respondents said that they were happy with how they were informed about the project and could make an informed decision to take part. Similar levels of satisfaction were reported about the installation of home equipment and the levels of support available throughout the pilot duration. Figure 6. Assessment of ICT components used by family carers to access the pilot service according to service client satisfaction questionnaire

98

 Integrated eCare in Dementia

Figure 7. Satisfaction with the pilot service by family carers according to service client satisfaction questionnaire

Assessment of Staff in ASI and TER of the Impact of the INDEPENDENT Project on People With Dementia and Their Family Carers Impact on People With Dementia Staff in ASI and TER were asked to provide their assessment of the impacts the INDEPENDENT system and service had on people with dementia and their family carers. In general, ASI staff felt that people with dementia were not aware of the telecare package as they had either moderate or severe dementia. However, they did identify some benefits for people with dementia. These were enhanced independence, security and safety. There was a husband and wife, [the door exit sensor] really reassured the wife, because he used to open the door and he ended up over…by the river a few times. It meant that she’d be alerted if he was gone… she was very reassured to have it. One staff member gave an example of one person with dementia who developed a urinary tract infection. This was detected by the relevant ASI Service Manager who noticed a changed in the activity patterns of the person with dementia via the web portal.

99

 Integrated eCare in Dementia

We did have an instance with a lady where we picked up a UTI [urinary tract infection] by realizing she was getting up at night. We asked the family to check her sample and she did have an infection, so health-wise, nobody would have known that, because there was nobody in the house with her. The impact on the ability of people with dementia to live at home for longer was slightly more complex from the point of view of ASI staff members. In some cases, it was possible that someone with dementia could enter long-term care earlier, due to the INDEPENDENT system (the telecare package and the web portal), allowing ASI staff to pick up risky behaviors in the home (such as wandering) that had not been observed before. …two of the clients actually ended up in long-term care as a result of having the package at home because it highlighted how dangerous it was for them to live at home. On the other hand, telecare and the portal could work to maintain people with dementia at home for longer, either indirectly by supporting family carers, or directly by reducing risk in the home and allowing ASI staff members to identify patterns and trends and adjusting the care plan accordingly. We had one case where there was a lady and we were sending in a carer at half-eight but through the portal we were seeing that she was leaving the house at half seven, and…we spoke to the family and then the carers was going in at half seven to stop her from leaving the house so she was more settled. TER staff also felt that telecare supported people with dementia to stay in their own homes for longer. The TER staff highlighted the personal aspect of the system, and felt that this is as important as the technological aspect. They could pick up on distress on the part of the person with dementia and communicate this to carers. Even though it is technology-based, it is coming back to the personal calls so they can elaborate…the oneon-one getting back to the carer “look we do feel that she’s probably getting a little bit distressed now” TER staff also described some minor negative impacts of the telecare system on people with dementia, mostly centered on the red light on the base unit. This red light is on constantly when the base unit is live. People with dementia sometimes think this indicates an appliance that is on standby that needs to be unplugged before they go to bed at night. They can become frustrated and agitated if they are unable to turn off the light. [People with dementia] want to turn off this red light because that would mean that maybe everything was plugged out at night…sometimes it can lead to frustration. Impact on Family Carers Key benefits for family carers identified by ASI staff included reduced stress, better quality of sleep and reduced carer burden. These benefits were felt to be due to the telecare package itself more than the web portal as family carers were not interacting with the portal directly. The fact that the telecare service was available 24 hours a day was seen as providing reassurance for family carers.

100

 Integrated eCare in Dementia

I think it’s helped them in that knowing that there’s somebody else there, that they’re not alone. They can press a button or if it’s an emergency, somebody’s there, they call the ambulance for them if it’s needed, they talk to them, and it just gives that little bit of reassurance and they feel safer. TER staff felt that telecare supported family carers to leave the house to run errands, for example. It does allow them to run to the shop and if something happens in between, knowing that at least if an alarm is raised they’ll be notified about it. Finally, and importantly, the staff in TER said that they try to balance the needs of the person with dementia against those of the family carer. They try to balance the situation of the person with dementia against raising the alarm unnecessarily, and they pick up on changes in patterns of alerts and events over the course of a day (times when people with dementia are more prone to engage in ‘risky’ behaviors such as leaving the house), or over time as the disease progresses. You don’t want to raise the alarm unnecessarily, but if it does get to a certain point it is the ability to speak personally with the carer that is of huge benefit.

Logged Activity on Activations of Telecare Devices The data presented in the table below represent the total number of activations for each device in the telecare system across end users for the period January 1st 2012, to October 31st, 2013. The total number of activations was 1,661. The average number of activations per individual user was 24 (minimum = 0 activations, maximum = 121 activations). Two devices require the interaction of the user with the devices, these are the pendant alarm and the alert button (the red button on the base unit attached to the landline). 252 (15% of total activations) for the pendant and 371 (22% of total activations) occurred. Of the passive sensors (that do not require the user to interact with the sensor), the property exit sensor was activated most frequently (344 activations, 21% of all activations), followed by the temperature rise sensors (232 activations, 14% of all activations) and the bed/chair sensors (184 activations, 11% of all activations). The natural gas detector was activated least (7 activations, 5% of all activations.

Logged Activity on the Web Portal A total of 1,800 logins to the web portal were been made since it first went live in July, 2013. Nineteen changes to care plans were made as a result of the telecare information available from the portal. Table 1. Telecare activations by type of device or sensor for period January 1st, 2012 to October 31st, 2013 Device Number of activations

Pendant

252

Alert Button 371

Bogus Caller 31

Flood Detector 42

Temperature Increase 232

Smoke Detector 138

Property Exit Sensor 344

Bed/ Chair Sensor 184

Natural Gas 7

Carbon Monoxide Detector 15

Fall Detector 46

101

 Integrated eCare in Dementia

THE IMPACT OF THE INDEPENDENT PROJECT ON STAFF IN TER AND ASI Staff Assessment of Impact of the INDEPENDENT Project on Their Work There were mixed views on the part of ASI staff regarding how the INDEPENDENT system and service impacted on their own work. They felt that the telecare packages themselves gave them reassurance about the safety of their clients Even for me it was a reassurance that it was there. However, their views on how the web portal had impacted on their work were mixed. Some ASI staff felt that INDEPENDENT had had some positive effect on their work, due to the ability to look up information on alerts and events via the portal, as well as to plan care and to make the best of existing resources. It meant that when we had a case conference or if an issue came up that I could print out a report and I could say “look Mary has left the house four times today, if somebody could call to see her at 11 o’clock to see how she is’. So it was very useful for being able to talk to the family and show them this. Staff also reported gaining satisfaction from the sense that somebody with dementia was secure and safe with the telecare installed, as well as being able to provide some kind of service to families at a time when other services are under severe constraint. …one of the clients I didn’t even do any home care…it was just the package that they had…so I suppose I felt satisfied that I’d helped them in some way. However, all ASI staff felt that the portal was difficult to use and this impacted negatively on their workload. They viewed logging into the portal as an extra task within the same time resource as before. ASI staff are under pressure to deal with a large caseload, only some of whom have telecare. They have to prioritize the most urgent or difficult cases. I think because of everything else especially in home care and day care, it’s such a reactive environment that we work in, to actually factor in the telecare portal, you really wouldn’t think of doing it unless it’s highlighted to you. An extra job, really, within the time limits that we have, but you get on with it! It should be noted that it had been planned to integrate the web portal with another software platform used by the ASI, but this was not achieved by the ASI in the lifetime of the INDEPENDENT project. This lack of integration may have increased resistance from some ASI staff to using the portal and led to a perception that using it was an extra task on top of their other daily activities Another issue was the difficulty in navigating the portal. For example, it was difficult for ASI to search for individual clients, and some reported having to scroll through their entire client list to find one individual. Difficulty in producing reports was also identified as a problem. 102

 Integrated eCare in Dementia

ASI staff felt that the portal had had an impact on the planning of care for people with dementia. However, they felt that there were still some issues that made it difficult for them to use the portal with maximum efficacy. One major problem experienced by ASI staff was the lack of information provided by TER staff regarding events and alerts. ASI staff need to know the process of responding to an event, and the end result of an event so that when they follow up with a family they are properly informed. We need to be aware of did Mary just get up to go to the bathroom and not come back in time, or did she get up to go to the front door? They’re two very different alerts and we’re not getting that detail of information. TER staff did not report any significant impact on their work or their ability to do their normal key tasks in their job. They said that they were able to carry on dealing with calls as they come in. They follow guidelines on responding to calls that are set by family carers. For example, for some people with dementia, the family requests that the response be made to a member of the family rather than the client. However, this was not specific to the INDEPENDENT project.

Key Informant Assessment of the Impact of the INDEPENDENT Project on Staff Telecare Key informants in the ASI felt that in the main, the roll-out of the telecare packages had had a positive impact on the Service Managers and Care Co-ordinators in that telecare was something that could be offered to clients and families who were on waiting lists for services, and an enhancement of care. They were able to talk to clients about it being another service that we could provide, it was an enhancement. However, the ASI key informants felt that in the initial stages it was difficult for staff to get used to the telecare and to achieve uptake on the part of the families. Staff had reported feeling that they were trying to ‘sell’ telecare in the beginning. It was just at the initial stage, getting used to it, and trying to convince families…it was like a selling job. This process was reported as time-consuming for staff and added to their workload at first. However, as the project progressed, it was felt that staff incorporated telecare-related tasks such as assessments into their work. The TER General Manager felt that the roll-out of telecare had had an impact on staff, because the dementia-specific telecare packages were mainstreamed, and certain tasks shifted from sales staff to call centre staff. However, he felt that the staff adapted to this and implemented best practice. Prior to the portal everything was channeled through our sales staff in terms of recycles, assessments, installations, so that was a change. It was a learning curve for everybody but we’ve learned from it and we’ve implemented best practice.

103

 Integrated eCare in Dementia

The Web Portal ASI key informants said that using the web portal possibly took time away from other tasks that staff had to do, especially at first, when familiarizing themselves with the portal. Again, as time went on, the key informants felt that the time needed to interact with the portal had reduced. I’d say it probably took them away a little bit from other key tasks at the start, with the training and getting used to it. But when people have started to use the portal…it doesn’t take much time. ASI key informants saw the access to live information via the web portal as very beneficial for staff as it enhanced their communication with families, and enhanced the staff’s own awareness of what was going on inside the home. They could access live information, they weren’t waiting for monthly reports, which enhanced their communication with the families. The TER General Manager did not feel that the INDEPENDENT project has impacted significantly on the call centre staff. Their work had not changed during the project. However, there had been benefits for managers in TER, as they no longer had to generate reports on telecare for the ASI Care Co-ordinators. The benefit really is to our management structure, who don’t have to generate reports because it’s automated.

Staff Assessment of the Technology Used in the INDEPENDENT Project Telecare All staff interviewed in ASI and TER felt that the telecare packages were easy to use and reliable for people with dementia, and especially for family carers. There were some devices that sometimes caused minor issues for families such as the bed pressure sensor and the property exit sensor. These issues were mainly to do with timings and flexibility of these sensors, and their fit with the individual needs of the client. You can only set it for a certain time [the property exit sensor] and if someone goes in after that time it goes off and then [the family carer] has to explain him or herself and it’s a little bit rigid. Staff in TER said that sometimes the person with dementia interacts with the system, either by using the pendant, or by pressing the red button on the base unit. These interactions are not normally an indication that the person needs help, but that the person is interested in the red button. In some cases the person with dementia views the red light on the base unit as an indication that an appliance is not switched off and will attempt to turn it off before going to bed at night. Overall, however, the telecare packages were viewed as easy to use and reliable.

104

 Integrated eCare in Dementia

The Web Portal A number of difficulties were identified by ASI staff regarding ease of use of the portal. Some staff said they had problems logging in to the portal. The only problem is an ongoing problem with the login. The ASI staff also reported problems in searching for clients by name and/or house number, which led to frustration on their part. I had to try and find my client and I discovered after a while that I even had to put in the number of the house. It wasn’t even coming up for me and I was getting really frustrated. The lack of ability to search for client names meant that some staff had to scroll through client lists to find the person they were looking for. This was not so much a problem where there were only a few telecare packages in their caseload, but for others it was more time consuming. This led to some ASI staff using the web portal relatively infrequently. It wasn’t allowing me to go in. I kept having to get the login reset. Now I’m afraid to touch it. The TER staff member who worked with ASI Service Managers to train them in the use of the portal also felt that it was not easy to use. This person felt that the portal relied heavily on the layout of Tunstall’s PNC software and used terminology that was not familiar to ASI staff. ‘I think that it’s too obviously developed by a person that’s very familiar with the PNC database layout, and has built it around that rather than coming at it from the ASI staff’s point of view.’

DEGREE OF INTEGRATION BETWEEN ASI AND TER ACHIEVED DURING THE INDEPENDENT PROJECT Staff Assessment of Integration Staff in ASI and TER were asked to give their assessment of how the process of integration worked in the INDEPENDENT project. Specifically, they were asked how effective the sharing of information from the web portal via the database had been and now effective the process of deploying the telecare equipment via the web portal had been. Information sharing was an area of concern for ASI staff. They did not feel that sufficient information about the nature of telecare alerts and their outcomes was available on the portal. This was partly due to the different terminologies used in ASI and TER. An example was given of the use of the term ‘reassurance’. To TER staff, ‘reassurance’ means that the client reassures the TER call centre operator, however to ASI staff it means that TER had provided reassurance to the client. If a client from the Alzheimer Society presses the button, you check in and they say “OK I’m fine, we close that down, that’s what we call a reassurance call. They’re reassuring us that they are ok. But when

105

 Integrated eCare in Dementia

the ASI Co-ordinators see ‘reassurance’ they think that that’s the client ringing up because they want us to reassure them. (TER staff member) In general, ASI staff said that they needed more information about the process of the call (who responded, what actions were taken) and more detail about the final outcome of the call (how the event was resolved) in order to follow up effectively. They should be writing notes in, so that they say “Client alerted us, wasn’t feeling well, ambulance was called.” That’s what the telecare is supposed to be doing for me, so you can get all the information about what happened. (ASI staff member) ASI staff members would also have liked more information about the installation process, specifically the date that telecare was installed in a home, what devices were installed and how devices can be used or adapted. A bit more communication around what’s gone in [telecare equipment], where it’s gone in, like, did the family agree with my recommendations. A bit more communication would be good. The functionality of the web portal in which an alert is sent to an ASI staff member in the case of a dangerous event was tested in INDEPENDENT for cases of wandering where the property exit sensor was triggered. This was seen as useful by ASI staff as it highlighted potential risk for their clients who had telecare and drew staff attention to the web portal.

Key Informant Assessment of Integration ASI key informants were positive about the level of integration of services between ASI and TER. They said that TER staff were always available to talk to if needed. TER training was delivered effectively and at the sites of ASI staff, which avoided the necessity of staff travelling for training. He sat by them and did it, which was very good, it made it very real for them because it was live, they were at their desk, rather than bringing them somewhere. (ASI key informant) The knowledge and working relationships between ASI and TER were also reported as having improved during the project. TER was described as being good providers of information about telecare and other assistive technologies, and contributing to presentations about the INDEPENDENT project. One key informant also said that trust in TER as a service provider had increased as a result of the partnership between the two organizations. That partnership has increased the trust so we know they want to provide an evidence-based service. (ASI key informant) The TER General Manager felt that while there had been good interaction with management in ASI, this had not always filtered down to the ASI frontline staff, especially in the initial stages of the project.

106

 Integrated eCare in Dementia

I think initially, there was a little bit of resistance in that they felt they were selling something. However, he did feel that there had been ‘champions’ of telecare among frontline staff, which had assisted the roll-out of the project. Working relationships between ASI and TER staff had strengthened as a result of the project. There was some very good interaction with some of the more pro-active co-ordinators in the ASI.

SOCIO-ECONOMIC ASPECTS AND SUSTAINABILITY Key Informant Assessment of the Potential for Mainstreaming and Sustainability Key informants were asked to identify what would need to be put in place to encourage the mainstreaming of INDEPENDENT. Two key factors were identified – the drawing up of a Service Level Agreement between TER and ASI, and the identification of a funding stream for more telecare packages. Efforts are being made to identify potential grants and revenue streams. We need to get more packages, we need to have a funding stream for packages, and it’s how we go about that, we are looking at different ways of doing that at the moment. Another factor in ongoing sustainability identified was refresher training in use of the portal on an annual basis, as well as workshops to facilitate shared learning across ASI staff. Key informants in ASI were of the view that the INDEPENDENT system should be implemented in the long term. They felt that the benefits brought by the web portal were worth any difficulties encountered when implementing the project, and reiterated the benefit that the project had brought to the reputation of ASI. Our standing as an organization, it has enhanced our credibility and profile as well. The ERL General Manager viewed the web portal as a method of enhancing ERL’s position in the telecare market. The organization is in discussions with external stakeholders such as the Department of Health and the HSE who have both shown interest in the portal, due to its potential to enhance care planning.

CONCLUSION The INDEPENDENT project in Ireland aimed to provide ASI Service Managers and Care Co-ordinators with information from telecare packages installed in the homes of people with dementia via a joint client database (known as a web portal in the project) between ASI and TER. This was implemented in order to enhance the amount of information at the ASI staff’s disposal and ultimately to improve care planning and decision-making. In addition, packages of telecare were installed in the homes of people 107

 Integrated eCare in Dementia

with dementia. The evaluation examined both the experiences of family carers of the telecare packages installed, and the experiences of staff and key stakeholders in ASI and TER of the telecare packages and the web portal. The results of the evaluation of family carers show no impact of telecare on either the burden of family carers (as measured by the ZBI) or on the proxy assessment of quality of life of people cared for (as measured by the QOL-AD). This could be explained by the low sample size, or that the dimensions measured by these two instruments do not overlap with the perceived benefits of telecare as identified by end users. This may be borne out by the high satisfaction rating given by family carers in terms of the telecare packages installed in the homes of the persons cared for. The key benefits they identified centered on a sense of security, peace of mind and reassurance as well as increased independence both for the people with dementia and for family carers. Staff in ASI and TER also identified reassurance and increased independence as benefits for people with dementia and family carers. In terms of the web portal, although there was a substantial number of logins to the portal, there were problems reported by staff and key informants with the design, layout and communication of information. This is perhaps understandable as the portal was an innovation and was developed as part of the project, whereas the telecare packages were based on established technology that was mature at the time of implementation. Staff in ASI saw a benefit of the portal regarding enhanced access to information and as a support in care planning and review. However, they also found the portal difficult to navigate and use. They also had information requirements that were not entirely met by the portal. This appeared to be as a result of the fact that the two organizations (ASI and TER) had different protocols and norms regarding the type and extent of information that is required. While the portal represented one level of integration, it did not account for integration in terms of common and agreed protocols for communication and information sharing between the two organizations. However, the extent to which this level of integration can be achieved between two separate organizations, one operating in the private commercial sector and the other in the not-for-profit social care sector, is limited by wider organizational cultures and constraints. Nonetheless, they key stakeholders, while noting the difficulties experienced by staff, were positive about the web portal developed in the INDEPENDENT project. They were also positive about the degree of integration achieved between ASI and TER at corporate level and felt that the portal should be implemented beyond the project duration. In summary, the web portal did bring advantages in terms of the availability of information on telecare alerts and events for ASI staff, notwithstanding the difficulties experienced in navigating and using it. Key stakeholders in ASI and TER both viewed the web portal as enhancing the reputation of their organizations and felt that the benefits of the portal outweighed any difficulties encountered when implementing the project.

REFERENCES Barlow, J., Bayer, S., & Curry, R. (2006). Implementing complex innovations in fluid multi-stakeholder environments: Experiences of ‘telecare’. Technovation, 26, 396–406. doi:10.1016/j.technovation.2005.06.010 Cahill, S., O’Shea, E., & Pierce, M. (2012). Creating excellence in dementia care: A research review for Ireland’s National Dementia Strategy. Dublin, Ireland: Trinity College Dublin & National University of Ireland, Galway. 108

 Integrated eCare in Dementia

Finch, T., May, C., Mair, F., Mort, M., & Gask, L. (2003). Integrating service development with evaluation in telehealthcare: An ethnographic study. British Medical Journal, 327, 1205–1209. doi:10.1136/ bmj.327.7425.1205 PMID:14630758 Fortin, J.-P., Gagnon, M.-P., & Lamothe, L. (2004). Evaluation of health care information and communication technologies: A framework to support decision-making. Paper presented at the IADS International Conference: eSociety 2004. Avila, Spain. Grabowski, T. J., & Damasio, A. R. (1997). Definition, clinical features and neuroanatomical basis of dementia. In M. M. Esir, V. M.-Y. Lee, & J. Q. Trojanowski (Eds.), The neuropathology of dementia. Cambridge, UK: Cambridge University Press. Heathfield, H., Pitty, D., & Hanka, R. (1998). Evaluating information technology in health care: Barriers and challenges. British Medical Journal, 316, 1959–1961. doi:10.1136/bmj.316.7149.1959 PMID:9641938 Jones, K. (2004). Enabling technologies for people with dementia: Report of the assessment study in England. Deliverable 4.1.1. Retrieved December 19th 2011 from http://www.enableproject.org/download/ Enable%20-%20National%20Report%20-%20UK.pdf O’Shea, E. (2000). The cost of caring for people with dementia and related cognitive impairments. Galway, Ireland: NUI Galway. O’Shea, E. (2007). Implementing policy for dementia care in Ireland: The time for action is now. Galway, Ireland: NUI Galway.

KEY TERMS AND DEFINITIONS Attrition: The loss of participants during a research study. Capacity Assessment: The process of examining and assessing whether or not an individual has the ability to understand information conveyed to them, and to make a decision based on that information. Dementia: Dementia is a term which describes a number of conditions that cause damage to the brain cells. Alzheimer’s disease is the most common cause of dementia (www.alzheimer.ie/About-Dementia/ what-is-dementia.aspx). Dyad: A group of two people linked to each other in some way (for example by family relationship or marital relationship) and analyzed in relation to each other. Telecare: Telecare involves the installation of sensors in the home in order to monitor and detect risk situations with a view to facilitating the independence and safety of the end user. The sensors are linked to a monitoring centre that alerts the relevant parties (for example, informal carers or emergency services) when a risk situation is detected, who then make the appropriate response (for example call to the house to check on the person). Triangulation: The use of different methods and different sources of data within a research study in order to corroborate and complement the research findings.

109

 Integrated eCare in Dementia

Web Portal: A joint client database developed during the INDEPENDENT project in Ireland that links information on patterns of alerts and events generated by the telecare system for telecare users who are also clients of the Alzheimer Society of Ireland with Service Managers and Care Co-ordinators employed by the Alzheimer Society of Ireland.

This research was previously published in Achieving Effective Integrated E-Care Beyond the Silos edited by Ingo Meyer, Sonja Müller, and Lutz Kubitschke, pages 314-331, copyright year 2014 by Medical Information Science Reference (an imprint of IGI Global).

110

Section 2

Autoimmune Diseases

112

Chapter 7

Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner Kevin J. Peine The University of North Carolina at Chapel Hill, USA

Eric M. Bachelder The University of North Carolina at Chapel Hill, USA

Naihan Chen The University of North Carolina at Chapel Hill, USA

Kristy M. Ainslie The University of North Carolina at Chapel Hill, USA

ABSTRACT Autoimmune diseases are the result of an improper immune response towards a self-antigen. Predominantly, autoimmune diseases have been treated using therapies that suppress systemic immune responses, which can result in significant side-effects like increased risk of infection and cancer. Alternatively, induction of immune tolerance through antigen-specific therapies can inhibit disease-associated responses without systemic suppression. Previously, immune tolerance has been accomplished by soluble antigen delivery through oral, nasal or sublingual routes. However, these therapies have shown minimal success in clinical settings. In an attempt to increase the efficacy of these therapies, recent work has utilized microparticulate delivery vehicles for the induction of immune tolerance. Microparticles are capable of increasing the solubility and circulation of cargo. In addition, their ability to passively target macrophages and dendritic cells increases their capacity for modulating the immune response. Recent work has shown microparticles fabricated with disease-associated antigens have limited disease progression and severity in animal models of Multiple Sclerosis, Type 1 Diabetes and Rheumatoid Arthritis. Inhibition of disease progression has corresponded with an antigen-specific decrease in inflammatory responses. The emerging field of inducing tolerance through microparticle-based therapies can limit therapeutic side-effects and increase patient quality of life by providing for long-term suppression of autoimmune disorders without compromising systemic immune function. DOI: 10.4018/978-1-5225-7122-3.ch007

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

INTRODUCTION Autoimmune Diseases According to the National Institutes of Health (NIH), approximately 23.5 million Americans are living with at least one autoimmune disease. These diseases, which can occur in almost any tissue, are the result of an improper immune response towards self-antigens. In some cases, such as systemic lupus erythematosus (SLE), the immune response mounts a response that targets multiple healthy tissues, while others like Multiple Sclerosis (MS), Type-1 Diabetes (T1D) or Rheumatoid Arthritis (RA) are more organ or site specific. Current therapeutic strategies for autoimmune diseases provide amelioration of symptoms, most commonly through systemic immune suppression, but fail to treat the underlying causes of disease. Although autoimmune diseases manifest themselves very differently, a number of current therapeutics have similar strategies for immune suppression, including inhibition of T cells, B cells, and pro-inflammatory cytokines. This chapter will discuss a number of therapeutic approaches for common autoimmune diseases, as well as the emerging field of nano/microparticulate therapeutics for the treatment of autoimmune diseases.

Multiple Sclerosis MS is a chronic demyelinating disease of the central nervous system (CNS) and affects nearly 2.5 million people worldwide, at a yearly cost burden of up to $54,000 per patient (Adelman, Rane, & Villa, 2013). T cells targeting auto-antigens in the CNS is believed to be the initial step that drives pathogenesis of MS (Friese, Schattling, & Fugger, 2014). Although the exact mechanism is not clearly known yet, the focal areas of demyelination in the white matter (plaques) are seen as the first site of attack. Immune cells (such as T cells and macrophages) invade across the blood–brain barrier, which further promotes inflammatory responses in the brain parenchyma, leading to demyelination and axonal degeneration (Smith & McDonald, 1999). Current therapies for MS have been successful at decreasing disease symptoms through a wide variety of immunomodulatory, antibody, or small molecule therapies. Interferon beta (IFN-β) (Avonex, Betaseron, Extavia, or Rebif) and glatiramer acetate (GA) (Copaxone) are frontline immunomodulatory therapies for the treatment of MS. IFN-β is a protein that was the first therapy to be accepted for use against MS. This injectable has shown to be effective at decreasing relapse rates, as well as slowing progressive forms of MS. Despite the wide usage of IFN-β, its specific mechanism is yet to be fully understood, though it has been associated with the inhibition of leukocyte migration, decreased inflammatory cytokines, and inhibition of T cell survival and expansion (Dhib-Jalbut & Marks, 2010). It is likely that a combination of these immunomodulatory properties is what makes IFN-β effective for some MS patients. However, a clinical study on IFN-β showed a large number of patients stopped low-dose therapy due to poor efficacy, while the most common causes of stopping high-dose therapy were adverse events, like flu-like symptoms (Ruggieri et al., 2003). Due to these drawbacks, alternative therapies are necessary for a large number of patients. GA is seen as a viable alternative to IFN-β (Vallittu et al., 2005). GA is a daily sub-cutaneous injectable that is a random sequence of four synthetic polypeptides resembling myelin protein. It is thought to be effective against MS by dampening pro-inflammatory responses in the brain, outcompeting endogenous myelin for antigen presentation by antigen presenting cells (APCs), and suppressing responses towards other myelin-associated antigens (Ziemssen & Schrempf, 2007). Though the exact mechanism has yet to be elucidated, GA has been a 113

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

successful therapy for MS. Over a 5 year study, GA lowered disease progression and disability scores in approximately 70% of patients (Johnson et al., 2000). GA displays a relatively tolerable safety profile, although side-effects including chest tightness and injection site reactions are experienced by ~30% of patients, resulting in them discontinuing GA therapy (Johnson et al., 2000; Vallittu et al., 2005). Although immunomodulatory therapies for MS have shown some clinical success, IFN-β fails to provide longterm protection (Shirani et al., 2012) and a number of patients fail both IFN-β and GA therapy (Vallittu et al., 2005), necessitating the usage of other therapies. Besides IFN-β, IL-10 also plays an important role in the disease progression of MS. Both IFN-β and IL-10 are regulated by NFATc1 (nuclear factor of activated T-cells). It was observed that mice bearing NFATc1−/− B cells showed milder symptoms of EAE (experimental autoimmune encephalomyelitis, a mouse model for human multiple sclerosis) (Bhattacharyya et al., 2011). However, non-specific immune suppression may elicit unwanted side effects, and more research needs to be down using more clinically relevant models. Both antibody and small molecule therapies have been used in patients that fail frontline immunomodulatory therapeutic regimens. Current antibody and small molecule therapies can inhibit MS symptoms by blocking some of the key immunological processes that lead to disease development. In healthy individuals, the blood brain barrier blocks the migration of inflammatory immune cells into the CNS (Larochelle, Alvarez, & Prat, 2011). However, individuals with MS have a breakdown in this process, allowing leukocyte infiltration, which can induce or exacerbate an inflammatory environment within the CNS. Furthermore, infiltrating lymphocytes proliferating in response to disease-associated antigens further enhance inflammatory responses. Natalizumab (Tysabri), an intravenous monoclonal antibody therapy, is successful in decreasing MS symptoms by blockade of this leukocyte infiltration process. This is accomplished through binding of α4-integrin protein on leukocytes; inhibiting binding of α4-integrin to the endothelial protein, vascular cell adhesion molecule (VCAM)-1. The binding of α4-integrin and VCAM-1 is a necessary step for extravasation of leukocytes into inflamed tissues (D.T. Selewski, 2010), thus blockade decreases the number of extravasating inflammatory cells into the CNS. While this is advantageous for MS therapy, a decrease in leukocyte activity can lead to adverse events. Although Natalizumab was FDA-approved in 2004, it was withdrawn for a 2 year period because of an association to Progressive Multifocal Leukoencephalopathy (PML), a disease with mortality rates reaching 50%. PML is a disease occurring in patients with latent John Cunningham (JC) viral infections. In these patients, Natalizumab may contribute to enhanced viral replication by decreasing infiltration of T cells into the infected areas (Perkins et al., 2012). Furthermore, systemic immune suppression can affect the clearance of other pathogens or limit the ability to destroy cancerous cells. Although Natalizumab is effective against MS, its need for intravenous administration and potential adverse events indicate it should be used only after more desirable therapies have failed. Orally delivered small molecules like Fingolimod (GILENYA), Teriflunomide (Aubagio), and Dimethyl Fumarate (Tecfidera) are more desirable, partially because of their less invasive delivery routes. Fingolimod is a novel orally delivered small molecule that mimics sphingosine 1-phosphate. It is capable of binding to and down regulating sphingosine 1-phospate receptor1 (Chun & Hartung, 2010). The binding of this lymphocyte receptor to its ligand is a necessary step in the lymphoid egress pathway (Garris et al., 2013), thus its down regulation inhibits lymphocyte activity by inhibiting their ability to exit peripheral lymph nodes (Chun & Hartung, 2010). In addition to blocking lymphocytes from entering the CNS, limiting their proliferation has also shown to lessen MS symptoms. Teriflunomide, an orally delivered small molecule, significantly decreases T and B cell proliferation through inhibition of dihydro-orotate dehydrogenase, and subsequent inhibition of pyrimidine synthesis (Bar-Or, Pachner, 114

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Menguy-Vacheron, Kaplan, & Wiendl, 2014). Inhibition of dihydro-orotate dehydrogenase halts cell cycle progression in G1 phase (Ruckemann et al., 1998). Although effective at decreasing relapse rates in patients, early clinical data associates Fingolimod (Cohen & Chun, 2011) and Teriflunomide (J. Oh & O’Connor, 2014) with liver damage and an increased risk of infections. This increased risk of infection is likely due to the systemic immune suppression seen with broad-spectrum inhibition of T and B cell function. Both Fingolimod and Teriflunomide received FDA-approval within the previous 5 years, however, a more recently approved orally delivered small molecule is available. Dimethyl Fumarate (Tecfidera) was approved for use by the FDA in 2013. Little is known about the mechanism of action, but animal models have associated it with decreased T cell infiltration and an increase in anti-inflammatory cytokines (Linker & Gold, 2013). Recently, it has been suggested that Dimethyl Fumarate may function through inhibition of NF-κB leading to decreases in cytokines, as well as an inhibition of dendritic cell (DC) maturation (H. Peng et al., 2012). Although a clinical study showed Dimethyl Fumarate outperforms Teriflunomide and has similar efficacy to Fingolimod (Hutchinson et al., 2014), further research should be done on its long-term safety and efficacy profile (English & Aloi, 2015). Immunomodulatory, antibody, and small molecule therapies have all shown clinical success against MS. However, much of this success has occurred at the expense of systemic immune suppression. By limiting T and B cell function, as well as inhibiting inflammatory cytokines, therapies have left patients at risk of infections, cancers, and a number of other side-effects. Emerging therapies should be developed with the goal of decreasing disease-associated immune responses, while keeping the remainder of the immune system functioning. However, this problem is not unique to individuals with MS. Patients receiving treatment for RA and SLE face the same problems from therapy-associated immune suppression.

Rheumatoid Arthritis RA is a chronic, inflammatory disease resulting in severely debilitating damage to synovial spaces. It is a common autoimmune disorder that affects approximately 1% of the worldwide population (Gibofsky, 2012). The disease initiates by infiltration of fibroblasts and inflammatory cells into the synovial or joint spaces in the hands and feet. This results in an over expression of IL-1 and tumor necrosis factor alpha (TNF-α) (Cunnane, Hummel, Muller-Ladner, Gay, & Gay, 1998). Destructive enzymes, such as serine proteases, matrix metalloproteinases, and the cathepsins, which leads to cartilage and bone destruction. It has been estimated that the economic impact in the United States from RA patients reaches $128 Billion annually (Centers for Disease & Prevention, 2007). The goal of traditional RA therapy is to limit the progression of inflammation and subsequent joint damage, while decreasing joint pain. The most commonly used front-line therapies for RA are oral non-steroidal anti-inflammatory drugs (NSAIDs) (e.g., aspirin, celecoxib, ibuprofen, naproxen). NSAIDs are diverse molecules with classifications based on their chemical structures. These classifications include carboxylic acids (e.g., aspirin, ibuprofen, naproxen), enolic acids, non-acids, and cyclooxygenase (COX)-2 selective inhibitors (e.g., celecoxib) (Crofford, 2013). NSAIDs decrease inflammation through targeting the enzyme COX-2, which subsequently blocks the production of prostaglandins; compounds that are critical for pathogenic inflammatory responses in RA (Ricciotti & FitzGerald, 2011). Although NSAIDs are relatively inexpensive, easy to access, and are tolerated well for short-term use, they fail to halt overall disease progression (Quan, Thiele, Tian, & Wang, 2008). In addition, side-effects for chronic NSAID use include renal, hepatic and cardiovascular problems (Crofford, 2013). An alternative frontline therapy for RA is steroids like corticosteroids (e.g., prednisone, methylprednisolone). These small molecules can be administered orally or as an injectable. 115

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

These molecules have shown to slow the progression of RA primarily by binding corticosteroid receptors, activating an intracellular signaling response that results in decreased transcription of genes involved in inflammatory cytokine production (e.g., IL-1, IL-2, TNF-α) and T cell proliferation. Like NSAIDs, steroidal therapies fail to stop long-term disease progression and their sustained dosing can result in side-effects like osteoporosis or gastrointestinal problems (Buchman, 2001). However, short-term usage of NSAIDs and steroidal therapies display excellent efficacy and safety profiles. Due to this, it has been suggested these therapies be used until a more advanced therapeutic is prescribed and becomes effective (Quan et al., 2008). One of the more advanced classes of therapies is the disease modifying anti-rheumatic drugs (DMARDs). Although DMARDs have been shown to significantly decrease the progression of RA, they can take months to begin to be effective. For these periods, NSAIDs and steroids can provide a stopgap therapy until efficacy occurs. While a number of DMARDs exist, the fastest acting is methotrexate (MTX) (Trexall), which is an orally delivered or injectable small molecule. MTX provides direct antiinflammatory effects as well as decreasing inflammatory cytokines in a number of ways (Cutolo, Sulli, Pizzorni, Seriolo, & Straub, 2001). Like Teriflunomide therapy for MS, MTX is capable of decreasing pyrimidine production causing decreased proliferation of T cells. The inhibition of DNA synthesis by MTX has also been associated with an increase in purine metabolism, which subsequently results in increased levels of adenosine secretion from cells, which can limit inflammatory cytokine production (Cutolo et al., 2001). While MTX is effective in controlling RA and has been for decades, it is associated with serious adverse events, and clinical trials have reported patients on MTX are twice as likely to discontinue treatment versus controls (Lopez-Olivo et al., 2014). For these patients, other orally delivered small molecule DMARDs can be used. Leflunomide (Arava) and Sulfasalazine (Azulfidine) have long been used as therapies for RA. Interestingly, the active metabolite of Leflunomide is Teriflunomide, so inhibition of RA symptoms is through decreased T cell proliferation due to inhibition of dihydro-orotate dehydrogenase, and subsequent inhibition of pyrimidine synthesis (Fox et al., 1999). Sulfasalazine also suppresses symptoms in part by decreases in inflammatory cell proliferation. It is a prodrug that, when cleaved by gut bacteria, becomes the functional 5-aminosalicylic acid. This small molecule is capable of decreasing RA symptoms through interaction with a class of nuclear receptors that decrease proliferation, increase apoptosis (Desreumaux & Ghosh, 2006), and contributes to a decrease in inflammatory species (Couto et al., 2010). Decreasing inflammatory responses is an important part of protecting from joint destruction in RA. While these previous DMARDs primarily mediate pro-inflammatory cell inhibition, a newer option, Xeljanz, targets the Janus Kinase (JAK) signaling pathway, thus inhibiting cell signaling that can result in inflammatory cytokine production. While these therapies have worked for a number of patients with RA, a meta-analysis of studies evaluating the effects of DMARDs on RA patients shows a number of individuals withdraw therapy due to high toxicity or low efficacy (Maetzel et al., 2000). Biologics provide an alternative therapeutic option for patients who fail with DMARDs. Recently, biologics are emerging as a highly researched class of compounds for the treatment of RA. Although biologics are not a new concept, in the past few years a large number of them have gained FDA-approval. The most common biologics for RA treatment are antibody therapies. More specifically, antibodies targeting tumor necrosis factor alpha (TNF-α) (Cimzia, Exemptia, Humira, Remicade, or Simponi) have become exceedingly popular. Of these therapies, all but Remicade are deliverable by sub-cutaneous injection (Remicade by intravenous infusion). TNF-α is a desirable target because it plays a significant role in the pathogenesis of RA, contributing to increased recruitment and proliferation of inflammatory immune cells, as well as regulating pro-inflammatory cytokines and growth fac116

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

tors at sites of inflammation and damage (Feldmann & Maini, 2001). Although a blockade of TNF-α has shown to effectively reduce RA symptoms and progression, TNF-α plays key role in regulating the immune response, therefore its systemic non-specific suppression is capable of causing a number of side-effects. A meta-analysis of TNF-α inhibitors indicates an increased risk of malignancies after use (Bongartz et al., 2006). In fact, the FDA has instituted black box warnings for lymphoma and increased risks of infections while taking TNF blockers. Antibodies blocking TNF-α are not the only ones effective toward treating RA. IL-6 is a potent mediator of joint destruction (Md Yusof & Emery, 2013) and has been inhibited clinically by a monoclonal antibody that blocks IL-6 from binding to the IL-6 receptor (Actemra). Additionally, Rituxin is an intravenously delivered antibody against CD20, which mediates the depletion of B cells. In RA, autoantibodies are present in approximately 60% of patients (Bax, Huizinga, & Toes, 2014) so destruction of B cell populations likely eliminates a major contributor of pathogenesis. Although a large portion of biological therapies are antibody-based, protein-based therapies have been clinically effective for RA. One major protein-based therapeutic technology is Fc-fusion proteins. These are protein or peptide sequences fused to the Fc region of an immunoglobulin (Czajkowsky, Hu, Shao, & Pleass, 2012). Orencia is a fusion protein that functions to inhibit the progression of RA by halting T cell activation. It is formulated by fusing the Fc region of an antibody with cytotoxic T-lymphocyte associated protein 4 (CTLA4). This formulation can outcompete for binding of CD80/86 on APCs. Patients on Orencia see a normalization of inflammatory mediators, including TNF-α, out to a year from treatment (HerreroBeaumont, Martinez Calatrava, & Castaneda, 2012). Interestingly, the first anti-TNF agent for RA was the fusion-protein therapy Enbral. Human FC regions are fused to dimeric regions of the TNF-α receptor and administered subcutaneously. Enbral is capable of binding and neutralizing circulating TNF-α through the use of the TNF-α receptor proteins on the FC region (Haraoui & Bykerk, 2007). In addition to fusion-proteins, a protein biologic is available to block an important cytokine in RA pathogenesis. Increased levels of IL-1β in patients is correlated to joint symptoms from RA pathogenesis (Kay & Calabrese, 2004). Kineret is a recombinant version of the IL-1 receptor antagonist and functions by competing with IL-1 for receptor binding. By outcompeting for this binding site, Kineret is able to decrease the pathogenesis caused by IL-1 and its downstream interactions. Although inhibition of cytokines, T cell, and B cell responses has successfully suppressed RA pathogenesis in a number of clinical settings, these therapies can result in severe side-effects. Increased risk of serious infections, as well as an increase in malignancies has been seen, likely due to the wide-suppression of immune functions. Both MS and RA are autoimmune diseases that affect specific tissues however, the wide suppression caused by therapies are evident in the fact that much of this technology can apply to a disease that affects multiple tissues.

Systemic Lupus Erythematosus Unlike MS and RA, SLE is an autoimmune disease which mounts an immune response to a number of bodily tissues. SLE can damage an individual’s brain, skin, kidneys, or joints. Although SLE can affect most tissues and organs, its mechanism of pathogenesis predominantly involves pro-inflammatory cytokines, T cells, and B cells (Mohan & Putterman, 2015). Although the exact mechanism of SLE remains elusive, the disease pathogenesis is believed to involve complicated interactions among various genetic and environmental factors such as sex, ethnicity, and hormone profiles. Defective immune regulations that lead to the loss of immune tolerance toward self-antigens contributes significantly to the development of SLE (Mok & Lau, 2003). Many of the previously described therapies have shown clinical efficacy in 117

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

SLE patients. Like therapeutic options for RA; NSAIDs, steroidal therapies, and disease-modifying drugs are established options for limiting the severity of SLE symptoms. Prednisone and methylprednisolone are two of the most common frontline therapies for SLE patients. However, efficacy is tied to high-dose therapy and recently long-term reliance on corticosteroids by SLE patients has been associated with an increased risk of organ failure (Zonana-Nacach, Barr, Magder, & Petri, 2000). The possibility of organ failure, coupled with increased risks from immunosuppression as well as decreased bone density from these therapies, have resulted in a push for dose-sparing therapeutic regimens to be developed. One method for limiting the amount of corticosteroids administered to SLE patients is through cotherapy with another compound. Due to the ability of MTX to inhibit T cell proliferation and inflammatory cytokines, its co-delivery with steroidal therapies has been explored. However, conflicting results have been established including one study showing no overall reduction in steroid use was achieved (Kipen, Littlejohn, & Morand, 1997), while another indicates MTX co-therapy is able to reduce the number of patients on high dose steroids (Carneiro & Sato, 1999). Aside from co-therapy, the use of an alternative therapy is desirable. Due to its success as an oral small molecule DMARD for RA, Leflunomide has recently been studied as an alternative to steroid-based therapies for SLE. Leflunomide has shown to inhibit disease progression and been effective as a monotherapy, however, its association with its immunological, hepatic, and respiratory side-effects indicate further long-term studies should be performed (Wu, Xu, Huang, & Wu, 2013). Though MTX and Leflunomide are emerging alternatives to corticosteroids for the treatment of SLE, other therapies have long been used to suppress disease progression. A small molecule that has been used for severe SLE cases is Cyclophosphamide (Cytoxan). Cyclophosphamide is an alkylating agent that causes depletion of immunological cells through inhibition of proliferation, and has been shown to be highly effective at inhibiting organ failure in patients with severe SLE (Petri, 2004). However, cyclophosphamide has severe side-effects that limit its use, including up to 50% of women on cyclophosphamide suffering from ovarian failure (Amissah-Arthur & Gordon, 2010). Predominantly, SLE patients are women so side-effects disproportionally impacting women are problematic. Other small molecule options are available for those patients with less sever SLE. Although its efficacy in severe SLE is minimal (Abu-Shakra & Shoenfeld, 2001), Azathioprine (Imuran, Azasan) is effective at slowing the progression of patients with mild SLE. Azathioprine is a small molecule that becomes incorporated into replicating DNA and blocks purine synthesis, which is likely how it inhibits broad T cell proliferation (Maltzman & Koretzky, 2003). Recently, for patients with mild to severe SLE who have failed steroidal, Cyclophosphamide, or Azathioprine treatments, Mycophenolate (CellCept) has been explored. Mycophenolate inhibits T and B cell proliferation, primarily through preferential depletion of guanosine nucleotides in T and B cells, leading to decreases in proliferation (Allison, 2005). Clinical data shows Mycophenolate is a viable small molecule alternative for patients who have failed previous therapies for SLE (Karim et al., 2002). However, patients in childbearing years should be cautious as it has been associated with increased pregnancy complications including miscarriage (Pisoni & D’Cruz, 2008). Therapies for SLE have varying efficacies, which may depend on toxicity of therapy, organs afflicted, and severity of disease. Many therapies for SLE decrease disease severity through systemic immune suppression, which in-turn can result in a number of side-effects like cancers and infections. In fact, a number of therapies with efficacy in SLE have been used for other autoimmune diseases. The ability for these treatment regimens to suppress broad immune responses is only highlighted by their efficacy across multiple tissues. Emerging therapies should be developed that inhibit tissue or diseasespecific autoimmune responses while maintaining an adequate immune response towards other antigens.

118

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Type 1 Diabetes One autoimmune disease with a unique, although not immunomodulatory, disease-specific therapeutic regimen is T1D. T1D is a T cell mediated autoimmune disease resulting in the destruction of insulin producing pancreatic β-cells (Burn, 2010). Destruction of these insulin producing cells inhibits proper glucose storage and leads to fatal symptoms if left untreated. According to the National Institutes of Health, approximately 80 people are diagnosed in the United States daily, and the disease is reported to account for $14.9 billion in annual healthcare costs (Dall et al., 2009). The first line therapy for T1D is the administration of exogenous insulin to substitute lack of pancreatic production. Insulin administration in T1D patients is accomplished with a daily series of injections or through continuous low dose administration with a pump. Recent studies have suggested patients may respond better using an insulin pump than with sub-cutaneous injections (Atkinson, Eisenbarth, & Michels, 2014). Although insulin therapy has been critical in treatment of patients, multiple daily injections are less than ideal for patients. Unlike the other autoimmune diseases mentioned above, immunomodulatory therapies are for T1D are not clinically used. Recently, clinical studies evaluating monoclonal antibodies targeting CD3 on T cells showed initial efficacy, but ultimately failed clinical endpoints (Atkinson et al., 2014). Additionally, a CTLA-4 (Abatacept) fusion protein showed short-term efficacy in patients, though its long-term efficacy was sub-optimal (Orban et al., 2011). It is apparent that new therapies for T1D, and all other autoimmune diseases, should be developed. These therapies should not only decrease symptoms and protect from long-term disease progression, but also alter the course of disease without severe side-effects from systemic immunosuppression.

Immune Tolerance Although many of these therapies have increased patient quality of life, and limited autoimmune severity, systemic immune suppression is a significant side-effect. Inhibition of T cell, B cell, and cytokine function can increase the risks of severe infection, certain cancers, and other adverse events. Inhibiting these auto-reactive responses in a disease specific manner may provide a way to inhibit disease-associated responses while maintaining otherwise effective immune function. Eliminating auto-reactive immune responses would more closely resemble the protective effects of a healthy immune system. Healthy individuals are able to avoid autoimmunity in part through immune tolerance; a failure to mount an inflammatory response towards antigens. This tolerance is accomplished in part by processes known as central and peripheral tolerance. Central tolerance selects against auto-reactive T cells in the thymus, and B cells in the bone marrow (Hogquist, Baldwin, & Jameson, 2005), while peripheral tolerance describes the induction of immune tolerance in areas outside the thymus or bone marrow. During central and peripheral tolerance, T cells with reactivity towards self-antigens can be deleted, made anergic, or differentiated into alternative lineages like regulatory T cells (Pacholczyk & Kern, 2008), which actively inhibit effector cell reactivity towards self-antigens. Much of these tolerance mechanisms are mediated through APCs, like DCs. Predominantly, these cellular fates are decided through signaling from DCs that have been tolerized towards self-antigens. Tolerized DCs present self-antigen to T cells, but fail to deliver co-stimulatory signals required for activation and expansion (Xing & Hogquist, 2012). Without co-stimulatory signals, T cells become unreactive towards presented self-antigen. This mechanism naturally protects against responses towards apoptotic debris from healthy tissues (Hawiger et al., 2001), as well food antigens and commensal bacteria (Faria & Weiner, 2005). Much of the peripheral tolerance 119

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

induction that prevents inflammatory responses towards these antigens occurs at mucosal surfaces. By introducing self-antigens to mucosal surfaces, it may be possible to direct a tolerogenic immune response, which can alter disease-associated immune responses while leaving the remainder of the immune system functional. Previously, antigen-specific tolerance has been accomplished through the ex-vivo manipulation of cells, as well as by introduction of antigens to mucosal surfaces. The induction of antigen-specific immune tolerance at mucosal sites has occurred through oral (Faria & Weiner, 2005) (Alpan, Bachelder, Isil, Arnheiter, & Matzinger, 2004), nasal (Maassen et al., 2003), and sublingual (Fleischer et al., 2013) delivery routes. In addition to delivering antigens to mucosal sites, ex vivo manipulation of immune cells is possible. Manipulated cells are expanded ex vivo and administration of cells has shown great promise inhibiting autoimmune responses. Ex vivo tolerogenic immune cells have been developed through a number of protocols. T cells receiving tolerogenic cytokine combinations, like Transforming Growth Factor beta (TGF-β) and IL-2, have shown to inhibit graft versus host disease and lupus animal models (Zheng et al., 2004). Tolerogenic T cells can also be created in vitro by blockade of co-stimulatory signals from co-cultured DCs (Taylor, Friedman, Korngold, Noelle, & Blazar, 2002). Although expansion of T cells is promising, alteration of APCs allows administration of a cell subset that can convert a large number of cells in vivo. Prior work has shown educated DCs can in-turn, educate multiple naïve T cell populations (Alpan et al., 2004). Additionally, Yamano et al. showed administration of bone marrow DCs expanded ex vivo with Flt3 ligand were capable of trafficking to the thymus and inducing central tolerance through clonal deletion (Yamano et al., 2011). These cells also functioned in peripheral tolerance by inducing anergy in auto-reactive populations (Yamano et al., 2011). Additional methods use peripheral tolerance mechanisms as well; specifically tolerance towards apoptotic cell debris. Taking advantage of high rates of erythrocyte apoptosis, Kontos et al. formulated antigen constructs that bind erythrocytes in vivo after intravenous administration (Kontos, Kourtis, Dane, & Hubbell, 2013). As the erythrocytes become apoptotic, they present bound auto-antigens to induce tolerance. This theory has also been tested using cells altered ex vivo. Parenteral delivery of ethylcarbodiimide (ECDI) treated splenocytes (Wang et al., 2014) or leukocytes (McCarthy, Bryant, Galvin, Miller, & Luo, 2015) coupled with autoantigens has induced immune tolerance through apoptotic clearance mechanisms. While these studies have all shown tolerance in animal models, and a recent Phase I clinical trial indicated antigen-coupled peripheral blood mononuclear cells were well tolerated (Lutterotti et al., 2013), however, the majority of antigen-specific therapy for autoimmune disease has yet to become clinically useable. The lack of effectiveness of inducible mucosal tolerance may be occurring for a number of reasons. One possibility for this is that more than one antigen is involved in clinical autoimmunity, so identifying and selecting correct antigens may be a crucial step for tolerance induction (Krause, Blank, & Shoenfeld, 2000). Antigen dosing quantities also play a critical role in immune regulation. Prior evidence suggests that low levels of antigen provide protection through direct regulation, while high doses result in clonal anergy and deletion (Weiner, 2000). This is especially interesting in the gut mucosal environment where a large portion of antigens may be degraded or denatured prior to interaction with APCs (Weiner, 2000). When choosing an antigen, it is important to determine differences between proteins and peptides. Protein administration may mimic disease-state antigens more accurately, but peptide administration is less prone to antibody neutralization or degradation (Peakman & Dayan, 2001). In addition, these differences may impact dose scheduling which has been shown to play a significant role in tolerance induction (Saklayen, Pesce, Pollak, & Michael, 1984). Alternatively, ex vivo expansion of tolerogenic cells eliminates the potential problems with in vivo antigen delivery; however, expansion of these cells 120

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

can be difficult and generally comes with considerable costs. It is necessary to find new methods for the delivery of tolerogenic therapies that can reduce cost, protect therapeutics from degradation, target immunological cells, and efficiently induce tolerogenic profiles.

BACKGROUND OF DRUG DELIVERY VEHICLES Drug delivery using nano/microparticulate carriers could provide a solution to a number of problems with tolerance-inducing therapies. Nanoparticles are those particles under 100 nm in size, while those over 100 nm are characterized as microparticles. Particulate vehicles can increase systemic circulation times of molecules and have been shown to increase pharmacokinetics of compounds, especially within plasma (Moghimi, Hunter, & Andresen, 2012). This is important for the delivery of more hydrophobic therapeutics, which require frequent low-dose administration for effective plasma levels (Savjani, Gajjar, & Savjani, 2012). Furthermore, encapsulation of peptides and proteins can also provide protection against systemic clearance mechanisms (e.g., enzymatic degradation, acidic degradation, opsonization). This can mitigate the issues seen with protein denaturation at mucosal sites which would decrease the activity of immunotolerance. Increased circulation and enhanced protection for the encapsulated cargo can decrease the amount of drug/protein required for therapeutic levels to be met. By decreasing the dosing requirements, it is possible to limit toxicity and cost of potential therapeutic regimens. Particlebased delivery of therapies can decrease clearance of cargo and dosing requirements while increasing the chance tolerogenic compounds are delivered within an appropriate therapeutic window. Another advantage in using particulate vehicles to modulate the immune response is their ability to passively target, and be readily taken up by APCs. Nanoparticles have been shown to interact with APCs by independently trafficking to draining lymph nodes, while microparticles were shown to be phagocytized at local sites of delivery (Manolova et al., 2008). Prior work using polymeric microparticles suggests that 2-3 µm particles are an optimal size for being phagocytized by macrophages (Champion, Walker, & Mitragotri, 2008), whereas 0.5-2 µm particles were more often associated with DCs (Manolova et al., 2008). Although, nanoparticles can be associated with APC uptake, they have also been shown to be taken up through endocytosis by alternative cell types, such as epithelial cells (N. Oh & Park, 2014). Liposomes have also shown uptake by macrophages in a size-dependent fashion. Sub-micron sized liposomes showed increased macrophage uptake with increased size, although this effect was diminished with liposomes greater than 1 µm in size (Chono, Tanino, Seki, & Morimoto, 2007). Although size plays a role in the passive targeting and subsequent uptake of particles by APCs, it is not the only factor that may impact particulate fate in vivo. Previous studies have suggested particles formulated from more hydrophobic materials have a preferential uptake compared to those formulated with hydrophilic materials (Chen, Langer, & Edwards, 1997; Tabata & Ikada, 1988). Furthermore, particulate shape and orientation relative to the macrophage may also determine if vehicles are phagocytized by macrophages (Champion & Mitragotri, 2006). Uptake by APCs at local sites, and in the lymph nodes, provides a mechanism for efficient delivery of tolerogenic compounds to the sites and cells necessary for tolerance induction. While particulate-based carriers provide a number of advantages for tolerance delivery, there are many types and formulation methods which should be explored.

121

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Particulate drug delivery vehicles have been formulated using a number of materials including polymers, lipids, and inorganics. Inorganic particulate vehicles, like those formulated from iron oxide or gold, have long been studied for drug delivery. Iron oxide nanoparticles can be formulated through multiple methods that enable low-cost production of large quantities and have uniform morphology (Gupta & Gupta, 2005). Iron oxide nanoparticles have been extensively studied and the technology has current approved clinical uses for imaging (Feridex, Feraheme). Similarly, gold nanoparticles (Figure 1) have been used for in vivo imaging, as well as the diagnosis and treatment of disease (Dreaden, Austin, Mackey, & El-Sayed, 2012). Treatment of disease has been accomplished through chemically binding therapeutics to nanoparticle surfaces. Therapies and imaging using gold nanoparticles to treat head/neck cancer (AuroLase, Aurimmune) and solid tumors (Auritol) are currently in clinical trials (Dobrovolskaia & McNeil, 2007). Although much research has been done on these technologies, iron oxide and gold nanoparticles are not biodegradable and can remain in tissues. Due to this, polymeric particles for drug delivery are a very popular alternative. Polymeric particles (Figure 1) have long been used for drug delivery purposes. Some of the most common particle formulation methods are oil-in-water (O/W) or water-in-oil-in-water (W/O/W) emulsification by processes such as homogenization, probe sonication, nanoprecipitation, solvent displaceFigure 1. Examples of gold nanoparticle, polymeric microparticle, or a liposome for delivery of tolerogenic cargo. The right panel shows a gold nanoparticle cartoon depicting the cargo on the surface only with a transmission electron micrograph (TEM) of a gold nanoparticle used for tolerance by Yeste et al. (Yeste, Nadeau, Burns, Weiner, & Quintana, 2012). This TEM is re-printed with permissions from PNAS. The center panel depicts potential cargo locations using polymeric delivery vehicles with a scanning electron micrograph of microparticles formulated by homogenization. The right panel shows a liposome where cargo is incorporated into the core. This is accompanied by a TEM of liposomal delivery vehicles.

122

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

ment (Anton, Benoit, & Saulnier, 2008), or electrohydrodynamic spraying (Duong et al., 2013). These techniques provide a way to encapsulate both hydrophobic and hydrophilic cargo. Much of this work has been performed using polyesters, such as poly(lactic-co-glycolic acid) (PLGA), poly-L-lactic acid (PLA) and polycaprolactone (PCL). Polyesters are advantageous because they have FDA-approval for many uses (e.g. sutures and drug delivery), are biodegradable (degradation is on the order of months to years (Labet & Thielemans, 2009; Lu et al., 2000)), and have low toxicity. However, using high concentrations of polyesters, coupled with sustained degradation, can cause accumulation of byproducts. These byproducts are capable of lowering local pH (Lu et al., 2000), which could cause tissue damage or detrimentally alter acid-sensitive cargo (e.g. proteins). In addition to polyesters, polyanhydrides (e.g. sebacic acid, p-(carboxyphenoxy)propane, or p-(carboxyphenoxy)hexane) degrade, are biodegradable, and have been used clinically (e.g., Gliadel). However, polyanhydrides are hydrolytically unstable (Vilar, Tulla-Puche, & Albericio, 2012) and are non-degradable at low pH. Due to the low pH of intracellular phagolysosomes of APCs, Keselowsky et al. have suggested pH-sensitive polymers could provide a number of benefits for delivery of autoimmune therapies (Keselowsky, Xia, & Clare-Salzler, 2011). Unlike polyesters and polyanhydrides, a novel polymer capable of degrading at acidic pH conditions and not producing acidic byproducts is acetalated dextran (Ac-DEX). Ac-DEX is formed by replacing the hydroxyl groups on dextran, a polysaccharide of glucose, with acetal groups (Bachelder et al., 2008). Ac-DEX has a favorable tunable degradation profile and is biocompatible. Other polymer-based therapeutics have been FDA-approved for the treatment of MS (glatiramer acetate; Copaxone) and RA (certolizumab pegol; CIMZIA). Although these therapies are not nano/microparticles, they highlight the increasing interest and potential of polymers for the treatment of autoimmune diseases. Liposomes (Figure 1), which are composed of a phospholipid bilayer, are another particulate vehicle used for drug delivery. Primarily, manufacturing is done through batch processes using lipid-film hydration, solvent vaporization, or ethanol injection. Like polymeric particles, liposomes have the ability to encapsulate both hydrophobic and hydrophilic cargo. Hydrophobic compounds placed in the lipid phase, or hydrophilic compounds placed within the aqueous buffer, are readily encapsulated within the vesicles. Liposomes are biodegradable and have tolerable degradation products however, a number of issues do exist. Batch processes can increase costs and yield variable particle heterogeneity. To alleviate this, many methods utilize extrusion through membranes to make more homogenous populations (Laouini, Charcosset, Fessi, Holdich, & Vladisavljevic, 2013). Due to drug leaking and particle aggregation, liposomes can also have poor shelf lives (Nounou, El-Khordagui, & Khalafallah, 2005). Despite these drawbacks, a number of liposomal formulations encapsulating therapeutics for cancer (Doxil, Myocet), infectious diseases (AmBisome), and other formulations containing inactivated hepatitis A virus (Epaxal) and inactivated influenza hemaglutinine (Inflexal V) are being used in clinics (Chang & Yeh, 2012). The approval of these formulations highlights the long-term success and potential of this delivery method. Particulate formulation using inorganic, polymer, or lipid constituents provides a novel method for delivery of tolerizing therapies. These technologies provide protection for sensitive proteins and peptides, as well as increase the circulation time for cargo. In addition, particulate vehicles passively target DCs, which provides a unique mechanism for directing tolerogenic processes. Due to the many advantages seen with nano/microparticulate vehicles, researchers have begun to explore particulate delivery vehicles for the treatment of autoimmune disorders.

123

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

NANO/MICROPARTICLES FOR THE TREATMENT OF AUTOIMMUNITY Current Research in the Field The most widely used model to study nano/microparticle therapy for autoimmunity is experimental autoimmune encephalomyelitis (EAE). This is an animal model of MS, and can be induced through a number of mechanisms. EAE severity can be measured through assignment of a clinical score, where 0 is a healthy animal and 5 is suffering from full paralysis. Two commonly used methods of induction are immunization against Myelin Basic Protein (MBP) or Myelin Oligodendrocyte Glycoprotein (MOG). MBP is the second most prevalent protein within the CNS and is responsible for efficient signaling along axons (Boggs, 2006), while MOG is less abundant, but is thought to play a significant role in the immune response towards myelin (Reindl, Di Pauli, Rostasy, & Berger, 2013). Immunization of C57Bl/6 mice with either MBP or MOG creates a well characterized form of EAE that has chronic progressive pathogenesis (Miller & Karpus, 2007). The immune response seen in these animals is overwhelmingly antigen specific, therefore making it an excellent model to study antigen specific tolerance. Induction of EAE in Swiss Jim Lambert (SJL) mice, most commonly through immunization with Proteolipid Protein (PLP), results in a relapsing and remitting form of EAE (rr-EAE). PLP is the majority constituent of myelin and the pathogenesis of EAE in SJL mice immunized with PLP is T cell mediated and can influence auto-reactive responses towards multiple antigens (Miller & Karpus, 2007). The SJL rr-EAE model is more closely related to clinical MS manifestations. These mouse models provide well established antigen-specific disease models for which to examine tolerance inductions through the use of particulate carriers. As a particulate carrier to treat an EAE model, Yeste et al. first used gold nanoparticles to co-deliver MOG with 2-(1’H-indole-3’-carbonyl)-thiazole-4-carboxylic acid methyl ester (ITE), a small mucosal ligand shown to induce anti-inflammatory cytokines and expand FOXp3+ T cells (Figure 1) (Yeste et al., 2012). Gold nanoparticles (60nm) functionalized with surface bound ITE and MOG (MOG/ITE/NPs) were stabilized by a single layer of thiol-polyethylene glycol (thiol-PEG). Initial in vitro studies of MOG/ ITE/NPs showed they significantly reduced inflammatory cytokine production and increased FOXp3+ expression in MOG-specific T cells. When MOG/ITE/NPs were administered intra-peritoneally, at the time of disease immunization, they significantly inhibited disease onset. The mechanism, determined by in vitro studies, was supported by the disease model. Mice treated with MOG/ITE/NPs showed decreased levels of IFN-γ and IL-17, as well as increased FOXp3+ T cells. The role of CD4+ FoxP3+ Tregs was confirmed when mice were protected from EAE after receiving T cells isolated from MOG/ITE/NPs treated mice. Furthermore, these nanoparticles lowered the clinical score in SJL mice when administered after symptom onset. The gold nanoparticles used by Yeste et al. provide for a potential antigen-specific therapy that can decrease established symptoms and slow the progression of MS. Previous work has examined tolerance induction through intravenous delivery of ECDI treated splenocytes (Wang et al., 2014) and leukocytes (McCarthy et al., 2015) coupled with autoantigens. One major drawback to this method of therapy is the difficult and often expensive process of ex vivo modification of cells. Expanding on this clinically relevant research, Getts et al. investigated the ability of antigen-decorated polystyrene beads (PSB) to mimic the effects of ex vivo antigen conjugated cells (Getts et al., 2012). Here, 500 nm PSBs were carboxylated and coupled with PLP139-151 (PLP/PSBs).

124

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

When administered intravenously, PLP/PSBs protected SJL mice from EAE onset. Mice treated with PLP/PSBs showed a broad inactivation of myelin-specific CD4+ T cells, as well as decreased leukocyte infiltration into the CNS. Coinciding with Yeste et al., cells treated with PLP/PSBs showed decreased proliferation and production of inflammatory cytokines (IFN-γ and IL-17). However, treatment coupled with CD25-antibody treatment only partially blocked induction of tolerance, suggesting FOXp3+ cells may only play a limited role in this system. Other possible T cell mediate roles are the induction of T cell anergy or T cell deletion. Interestingly, disease inhibition and tolerance induction seemed to be mediated through the splenic marginal zone macrophage receptor with collagenous structure (MARCO). PLP/PSBs co-localized with this subset of macrophages, which are partially responsible for tolerance towards apoptotic proteins (McGaha, Chen, Ravishankar, van Rooijen, & Karlsson, 2011). This result indicates that nano/microparticle delivery has the potential to take the place of expensive and complicated ex vivo therapies. Although effective, using MOG/ITE/NPs and PLP/PSBs to treat EAE should be improved upon. Both gold nanoparticles and PSBs are biocompatible however; they are not biodegradable and could pose long-term toxicity issues. With this in mind, Hunter et al. used antigen-conjugated PLGA microparticles for both prophylactic and therapeutic treatment of rr-EAE (Hunter et al., 2014). Microparticles were 500 nm in size and coupled with PLP (PLGA-PLP/MPs) at higher efficiencies than commercially available PSBs. When PLGA-PLP/MPs were administered intravenously, they were capable of delaying disease onset and ameliorating symptoms of established EAE. Moreover, PLGA-PLP/MPs treated naïve SJL mice showed enhanced protection after adoptive transfer of auto-reactive T cells and particulate treated mice showed limited demyelination and reduced inflammatory immune cell infiltration into the CNS. Like the previous two studies, protection was at least partially mediated through a decrease in IFN-γ and IL-17. Studies looking at antigen-decorated microparticles administered intravenously show promising results. One drawback to this work is intravenous administration is less desirable compared with subcutaneous delivery, as subcutaneous can be patient administered and intravenous usually requires a medical professional. Unlike Yeste et al., the work done by Getts et al. and Hunter et al. did not use a small molecule known to inhibit APC signaling. Further work looking at subcutaneous delivery methods, and formulations using immunomodulatory drugs would provide more insight into the feasibility of this technology. This was accomplished in part by Maldonado et al. who formulated PLGA nanoparticles encapsulating rapamycin, a small molecule known to inhibit co-stimulatory signals, and PLP (Rapa/PLP/NPs) (Maldonado et al., 2015). Although the effective delivery route seems to be intravenously for these vehicles, treatment with Rapa/PLP/MPs were able to prophylactically limit clinical scores in rr-EAE mice and intravenous administration ameliorated clinical scores and decreased relapse rates in a therapeutic fashion. Cappellano et al. also formulated 200 nm PLGA microparticles encapsulating MOG and the anti-inflammatory cytokine IL-10 (IL-10/MOG/MPs) (Cappellano et al., 2014). Subcutaneous administered significantly inhibited EAE development in a prophylactic fashion while concomitantly decreasing histopathological lesions in the spinal cord. Like the previous work, these mice showed lower levels of pro-inflammatory cytokines which corresponded with protection from EAE. As was previously discussed, high concentrations of polyesters, coupled with long degradation rates can cause accumulation of acidic byproducts (Lu et al., 2000). Sensitive cargo can be adversely impacted by this environment, and long degradation rates could lead to less optimal delivery of encapsulates (Broaders,

125

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Cohen, Beaudette, Bachelder, & Frechet, 2009). Evidence of this may be seen in Bryant et al. who previously showed that donor apoptotic splenocytes could induce long-term donor-specific tolerance to islet allografts, but donor antigen-coupled PLGA microparticles (PLGA-dAg) were sub-optimal compared with splenocytes (Bryant et al., 2014). It is important to explore alternative delivery formulations that could alleviate these issues. One polymer that could enhance the field of tolerance therapies is Ac-DEX. Ac-DEX is a novel biocompatible and biodegradable polymer with pH neutral byproducts. This polymer is also highly tunable, providing enhanced controlled release of therapeutics. Peine et al. used Ac-DEX to encapsulated MOG and dexamethasone (DXM), another small molecule known to inhibit co-stimulatory signals (Peine et al., 2014). These microparticles (DXM/MOG/MPs) not only contained a tolerogenic compound with an antigen, but were also subcutaneously administered, 3 days after symptom onset, and significantly decreased the clinical score in the chronic progressive C57Bl/6 model. Here, EAE is induced through immunization with Complete Fruend’s Adjuvant and MOG peptide, resulting in a mouse model characterized by a high degree of inflammation and high clinical scores. These mice went from an average clinical score of 3.4 to a clinical score of 1.6 after 3 injections. Interestingly, DXM/MOG/MPs significantly decreased clinical scores compared with microparticles encapsulating MOG only, suggesting the role of an immunomodulator is important. Antigen recall assays showed significantly lower levels of IL-17 and GM-CSF in mice treated with DXM/MOG/MPs. Although cytokine data corresponded with other EAE studies, there was no indication that FOXp3+ T cells had an impact on treatment of mice with EAE. Although most of the current work using particulate vehicles has been performed on EAE models, other autoimmune models provide useful systems to explore the use of nano/microparticles. In RA, T cells and autoantibodies within the synovial space have been implicated in pathogenesis. A number of animal models exist to study RA, including the collagen-induced arthritis (CIA) model, which is induced by immunization towards collagen in a similar fashion as EAE. This model mimics clinical disease through breaking tolerance to endogenous collagen, as well as the development of autoantibodies (Asquith, Miller, McInnes, & Liew, 2009). Although this model is considered the gold-standard for modeling RA, immunization with methylated bovine serum albumin (mBSA) followed by an intra-articular mBSA challenge is also widely used. This model is useful because it allows for extensive studies of T cell mediated responses in the synovial fluid. Capini et al. studied induction of immune tolerance using liposomal vehicles for therapy on the mBSA mouse model (Capini et al., 2009). Here, liposomes encapsulating mBSA and a lipophilic NF-κB inhibitor (curcumin, quercetin, or Bay11-7082) were tested against mice challenged with mBSA-induced inflammatory arthritis. The egg phosphatidylcholine liposomes (400 nm) were prepared by lipid film hydration and delivered by subcutaneous injection. This therapy ameliorated symptoms and lowered disease scores, likely due to the induction of antigen-specific regulatory CD4+ T cells. Liposomes encapsulating antigen and curcumin lowered antigen-specific T cell proliferation, reduced levels of IL-2, TNF, and IFN-γ, and increased secretion of IL-10 in the draining lymph nodes. There was an expanded population of antigen-specific FoxP3+ CD4+ regulatory T cells in the draining lymph nodes in response to the treatment. Therefore, Capini suggested that liposomes, loaded with an antigen and a NF-κB inhibitor, could induce antigen-specific tolerance by inducing development and expansion of FoxP3+ CD4+ Tregs, as well as inhibiting inflammatory cytokines. Particulate platforms have been effective here, and for EAE however, work is also being done to evaluate this technology for rarer diseases.

126

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Another serious but rare, autoimmune disorder is Acquired Hemophilia A (AHA). Here, antibodies are formed against coagulation factor VIII (factor 8). Factor 8 is a necessary protein involved in clotting of blood. In patients with no history of blood disorders, auto-antibodies can form towards factor 8. In addition, hemophiliacs receiving replacement protein therapy may develop inhibitory antibodies towards their therapy (Zhang, Skupsky, & Scott, 2009). Maldonado et al. demonstrated the efficacy PLGA nanoparticles as a delivery platform to treat AHA (Maldonado et al., 2015). Here, inhibition of autoantibodies was accomplished through co-therapy with factor 8 and factor 8/rapamycin loaded PLGA nanoparticles. The AHA model is advantageous because the disease-specific antigen is more clearly defined. This work, and the work previously discussed using EAE and RA models, provides a number of methods to achieve antigen-specific disease suppression. Limiting disease severity in these models provides a framework for new technologies to treat autoimmune diseases. Although these animal models are well established and useful, they are inducible models and may not fully represent the complexity of spontaneous disease onset. The Non-Obese Diabetic (NOD) model, which provides for reliable spontaneous disease onset mediated mostly by T cell infiltration, is the most common model used to research T1D. T1D is a T cell mediated autoimmune disease destroying insulin producing pancreatic β-cells. Along with the NOD model, T1D is studied using viral-mediated, adoptive transfer, and transgenic models (Van Belle, Taylor, & von Herrath, 2009). NOD models are commonly used because of the spontaneous onset of disease, and the high number of antigens involved in pathogenesis. Importantly, this can mimic clinical T1D and require correct antigen choice for therapies. These antigens include common diabetic-associated proteins like insulin or glutamic decarboxylase (GAD), as well as auto-reactive CD8+ T cells recognizing mimetopes relevant to human disease (Khadra, Tsai, Santamaria, & Edelstein-Keshet, 2010). Among these mimetopes is NRP-V7, which Tsai et al. coupled with MHC (NRP-V7-Kd) and coated on ~100 nm superparamagnetic iron oxide nanoparticles (NRP/NPs) (Tsai et al., 2010). NRP/NPs administered intravenously slowed NOD progression and restored normoglycemia. Recently, NOD-scid mice (lacking T and B cells) have been shown to be able to be populated with human haematolymphoid transplant. This transplant allows the study of human immune responses in an animal model. Tsai et al. utilized humanized NOD mice, treating them with the relevant antigen-coated iron oxide nanoparticles (hIGRP265-273 and insulin B10-18 peptide). These nanoparticles were effective at restoring normoglycemia and increasing the number of regulatory CD8+ T cells. These cells displayed a memory-like phenotype. Tsai et al. also saw fewer numbers of CD11c+ dendritic cells, suggesting the particulate treatment could have altered APC populations. The work by Tsai et al. not only alters the immune profile and disease progression in a spontaneous model of autoimmunity, it also shows a particulate platform is capable of altering the immune response in humanized mice. Utilization of these mice provides enhanced evidence that these therapeutic platforms may be translated into clinically useable therapies. The use of nano/microparticulate therapy for autoimmune disorders is a new and emerging field. To date, researchers have successfully utilized particulate technologies to alter immune responses in an antigen-specific manner. Alteration of these responses has led to protection against disease in animal models of MS, RA, AHA and T1D. The previously discussed work suggests protective effects by many formulations and delivery routes, across multiple disease models (Table 1). Much of the evidence points to protection stemming from a combination of decreased inflammatory cytokines and expansion of regulatory and tolerized cell populations. Though, there is some disparity between mechanisms in this work. Although the preliminary work looks promising, more work needs be done to progress the field into clinical relevance. 127

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Table 1. Details of publications using particulate carriers for immune tolerance therapies for the treatment of autoimmune diseases. Particulate Formulation

Approximate Size (nm)

Tolerogenic Compound

Gold Conjugated

60

Myelin Oligodendrocyte Glycoprotein

ITE Sequence

Multiple Sclerosis

Yeste A. et al., 2012

Polystyrene Beads

500

Proteolipid Protein or Myelin Oligodendrocyte Glycoprotein

n/a

Multiple Sclerosis

Getts DR. et al., 2012

PLG Conjugated

400-500

Proteolipid Protein

n/a

Multiple Sclerosis

Hunter Z. et al., 2014

PLGA Bulk Encapsulated

500

Proteolipid Protein

Rapamycin

Multiple Sclerosis

Maldonado RA. et al., 2014

Ac-DEX Bulk Encapsulated

200

Myelin Oligodendrocyte Glycoprotein

Dexamethasone

Multiple Sclerosis

Peine KJ. et al., 2014

PLGA Bulk Encapsulated

200

Myelin Oligodendrocyte Glycoprotein

rIL-10

Multiple Sclerosis

Cappellano G. et al., 2014

PLGA Bulk Encapsulated

500

Factor VIII

Rapamycin

Acquired Hemophilia A

Maldonado RA. et al., 2014

Iron Oxide Absorbed

100

NRP-V7, hIGRP, or Insulin B10 Peptide

n/a

Type 1 Diabetes

Tsai S. et al., 2010

Liposome

400

Methylated Bovine Serum Albumin

Curcumin, Quercetin, or Bay 11-7082

Antigen-Induced Arthritis

Capini C. et al., 2009

PLG Conjugated

450

Donor Antigen

Rapamycin

Transplant

Bryant J. et al., 2014

Antigen

Disease

Reference

FUTURE CHALLENGES AND RECOMMENDATIONS The autoimmune disorders discussed above are the most prevalent, but the NIH estimates over 80 diseases are caused by the immune system responding to self-antigens. Inflammatory reactions towards healthy tissues can have devastating effects on patients and their quality of life. Current therapies aim to alleviate symptoms of autoimmunity through systemic immune suppression, but this can result in a number of adverse events for patients. Therapeutics for disease-specific suppression is one method that could limit the prevalence of these adverse events. Much work has been done to introduce tolerance therapy into the clinics, however many of these technologies have failed. While delivery of these therapies in particulate vehicles solves many problems seen with tolerance induction, a number of issues should still be addressed. Incorrect identification of primary disease causing antigens may account for a number of failures seen clinically with tolerance therapies (Krause et al., 2000). While particulate vehicles can increase solubility and deliverability of cargo, they will only function if the correct antigens are selected. Delivering MOG, MBP, or PLP has become a mainstay for research into antigen-specific tolerance for MS. On the other hand, alternative peptides have shown to ameliorate symptoms in animal models induced with multiple myelin antigens (Nicholson, Murtaza, Hafler, Sette, & Kuchroo, 1997). Suppression of an antigen-specific response by an alternative antigen is likely caused through bystander effect, where the anti-inflammatory effect of some cells will alter the phenotype of neighboring cells. Further work

128

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

should be done to identify key peptides for therapies that have cross-reactivity over multiple antigens. Additionally, autoimmune disorders like MS are localized in specific tissue subsets, while diseases like SLE can have systemic reactivity. Auto-reactivity in SLE has been associated with antigens from self-DNA and nucleosomes, as well as possible foreign pathogen implications. It is vital that research is done to identify crucial antigens for all autoimmune diseases. Enhancing the understanding of antigens involved with autoimmune diseases will lead to the development of better antigen-specific therapies. While identifying antigens to deliver is important, so too is determining ideal particulate vehicles. While gold and iron oxide nanoparticles showed efficacy in treating autoimmune models, their lack of biodegradability could cause long-term toxicity. Similarly, vehicles with biodegradable properties may degrade at inopportune times, missing optimal delivery windows for cargo. Further work should be done to identify which particulate vehicle has the potential to give tunable release of cargo, while maintaining a reasonable safety profile. Furthermore, previous work using particulate carriers for the treatment of autoimmunity has been performed with protein adsorbed or conjugated to the particle surface, as well as bulk encapsulated within the particle. More research should be done to determine whether or not surface presentation of proteins can alter therapeutic efficacy. Adsorbing proteins to the surface of particles, as well as the interaction of proteins with biological environments, can lead to denaturation while bulk encapsulation provides protection from this (Di Marco et al., 2010). Identifying how denaturation of proteins affects tolerance will provide necessary knowledge to determine which formulation may work. In fact, Peng et al. have suggested that oral tolerance may be abrogated after heat (H. J. Peng, Chang, Tsai, et al., 1998) or chemical (H. J. Peng, Chang, Lin, Han, & Chang, 1998) denaturation. Alternatively, surface bound proteins can increase circulation times and decrease aggregation of particulate carriers within the blood stream. Therefore, surface-bound proteins could benefit intravenous particle delivery (Di Marco et al., 2010). With changes to particulate carriers altering therapeutic efficacy, it is necessary to also examine the effect of particle size and route of delivery on the protective ability of particles. The prior work on tolerance induction using particulate carriers has been performed using a variety of particle sizes and delivery routes. Yeste et al. accomplished tolerance induction in EAE through injection of antigen-decorated 60 nm nanoparticles injected intraperitoneally, while Getts et al. accomplished this using 500 nm antigen-decorated polymer microparticles intravenously. A great deal of previous work indicates that size and delivery method of particulate vehicles has a significant effect on tissue distribution and clearance rates (Longmire, Choyke, & Kobayashi, 2008). When determining delivery methods, it is also important to take patient quality of life under consideration. Therapies developed with clinical restraints in mind will allow for expeditious translation to marketable therapeutics. While oral delivery is the ideal delivery method, subcutaneous administration is preferable over intravenous delivery. In addition to clinical preferences in delivery methods, the timing of delivery should also be taken under consideration. Although models like EAE have been vital for drug discovery, administration of these emerging therapeutics should be done with clinically relevant time points in mind. Vesterinen et al. have provided a meta-analysis of EAE papers and shown as low as 30% of studies treat after disease induction, and as little as 5% of studies administer therapeutics after two weeks post-induction (Vesterinen et al., 2010). Diagnosis of MS prior to symptom onset is not yet possible. Therefore, experiments looking into particulate therapies should be performed after onset of EAE. Additionally, much of the current work examines the protective effect of induced FOXp3+ T cells after particulate administration, however much of this work has examined expansions of these cells after prophylactic administration. Inflammation and

129

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

immune signaling are altered during disease states, so mechanisms of therapeutic protection should be performed in models already afflicted with symptoms. To date, researchers have not provided adequate mechanisms of protection, so it is imperative that further research is done to elucidate a mechanism of protection seen with particulate-based tolerance therapies.

CONCLUSION Autoimmune disorders are the result of a breakdown in immune tolerance towards self-tissues. Therapies suppressing the immune system have been clinically effective, but the development of therapeutics specifically targeting disease-causing cells provides a more ideal method of treatment. Recent work has utilized organic, inorganic, or lipid-based particles to deliver therapeutics allowing immune suppression in an antigen specific response. This research has shown promising results in well characterized animal models. While this work has shown promise, it is still and emerging field and requires further research. Future work optimizing particle formulation, delivery routes, and elucidating mechanisms will provide much needed data to move forward into clinical settings. A number of particulate-based therapeutics have been FDA-approved for use in recent years and with the proper research and investment, particulatebased therapeutics will soon emerge as a powerful tool to combat autoimmune diseases.

REFERENCES Abu-Shakra, M., & Shoenfeld, Y. (2001). Azathioprine therapy for patients with systemic lupus erythematosus. Lupus, 10(3), 152–153. doi:10.1191/096120301676669495 PMID:11315344 Adelman, G., Rane, S. G., & Villa, K. F. (2013). The cost burden of multiple sclerosis in the United States: A systematic review of the literature. Journal of Medical Economics, 16(5), 639–647. doi:10.3 111/13696998.2013.778268 PMID:23425293 Allison, A. C. (2005). Mechanisms of action of mycophenolate mofetil. Lupus, 14(Suppl 1), s2–s8. doi:10.1177/096120330501400102 PMID:15803924 Alpan, O., Bachelder, E., Isil, E., Arnheiter, H., & Matzinger, P. (2004). ‘Educated’ dendritic cells act as messengers from memory to naive T helper cells. Nature Immunology, 5(6), 615–622. doi:10.1038/ ni1077 PMID:15156140 Amissah-Arthur, M. B., & Gordon, C. (2010). Contemporary treatment of systemic lupus erythematosus: An update for clinicians. Ther Adv Chronic Dis, 1(4), 163–175. doi:10.1177/2040622310380100 PMID:23251736 Anton, N., Benoit, J. P., & Saulnier, P. (2008). Design and production of nanoparticles formulated from nano-emulsion templates-a review. Journal of Controlled Release, 128(3), 185–199. doi:10.1016/j. jconrel.2008.02.007 PMID:18374443 Asquith, D. L., Miller, A. M., McInnes, I. B., & Liew, F. Y. (2009). Animal models of rheumatoid arthritis. European Journal of Immunology, 39(8), 2040–2044. doi:10.1002/eji.200939578 PMID:19672892

130

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Atkinson, M. A., Eisenbarth, G. S., & Michels, A. W. (2014). Type 1 diabetes. Lancet, 383(9911), 69–82. doi:10.1016/S0140-6736(13)60591-7 PMID:23890997 Bachelder, E. M., Beaudette, T. T., Broaders, K. E., Paramonov, S. E., Dashe, J., & Frechet, J. M. (2008). Acid-degradable polyurethane particles for protein-based vaccines: Biological evaluation and in vitro analysis of particle degradation products. Molecular Pharmaceutics, 5(5), 876–884. doi:10.1021/ mp800068x PMID:18710254 Bar-Or, A., Pachner, A., Menguy-Vacheron, F., Kaplan, J., & Wiendl, H. (2014). Teriflunomide and its mechanism of action in multiple sclerosis. Drugs, 74(6), 659–674. doi:10.100740265-014-0212-x PMID:24740824 Bax, M., Huizinga, T. W., & Toes, R. E. (2014). The pathogenic potential of autoreactive antibodies in rheumatoid arthritis. Seminars in Immunopathology, 36(3), 313–325. doi:10.100700281-014-0429-5 PMID:24763532 Bhattacharyya, S., Deb, J., Patra, A. K., Thuy Pham, D. A., Chen, W., Vaeth, M., ... Serfling, E. (2011). NFATc1 affects mouse splenic B cell function by controlling the calcineurin--NFAT signaling network. The Journal of Experimental Medicine, 208(4), 823–839. doi:10.1084/jem.20100945 PMID:21464221 Boggs, J. M. (2006). Myelin basic protein: A multifunctional protein. Cellular and Molecular Life Sciences, 63(17), 1945–1961. doi:10.100700018-006-6094-7 PMID:16794783 Bongartz, T., Sutton, A. J., Sweeting, M. J., Buchan, I., Matteson, E. L., & Montori, V. (2006). Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: Systematic review and meta-analysis of rare harmful effects in randomized controlled trials. Journal of the American Medical Association, 295(19), 2275–2285. doi:10.1001/jama.295.19.2275 PMID:16705109 Broaders, K. E., Cohen, J. A., Beaudette, T. T., Bachelder, E. M., & Frechet, J. M. (2009). Acetalated dextran is a chemically and biologically tunable material for particulate immunotherapy. Proceedings of the National Academy of Sciences of the United States of America, 106(14), 5497–5502. doi:10.1073/ pnas.0901592106 PMID:19321415 Bryant, J., Hlavaty, K. A., Zhang, X., Yap, W. T., Zhang, L., Shea, L. D., & Luo, X. (2014). Nanoparticle delivery of donor antigens for transplant tolerance in allogeneic islet transplantation. Biomaterials, 35(31), 8887–8894. doi:10.1016/j.biomaterials.2014.06.044 PMID:25066477 Buchman, A. L. (2001). Side effects of corticosteroid therapy. Journal of Clinical Gastroenterology, 33(4), 289–294. doi:10.1097/00004836-200110000-00006 PMID:11588541 Burn, P. (2010). Type 1 diabetes. Nature Reviews. Drug Discovery, 9(3), 187–188. doi:10.1038/nrd3097 PMID:20190784 Capini, C., Jaturanpinyo, M., Chang, H. I., Mutalik, S., McNally, A., Street, S., ... Thomas, R. (2009). Antigen-specific suppression of inflammatory arthritis using liposomes. Journal of Immunology (Baltimore, MD.: 1950), 182(6), 3556–3565. doi:10.4049/jimmunol.0802972 PMID:19265134

131

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Cappellano, G., Woldetsadik, A. D., Orilieri, E., Shivakumar, Y., Rizzi, M., Carniato, F., ... Dianzani, U. (2014). Subcutaneous inverse vaccination with PLGA particles loaded with a MOG peptide and IL10 decreases the severity of experimental autoimmune encephalomyelitis. Vaccine, 32(43), 5681–5689. doi:10.1016/j.vaccine.2014.08.016 PMID:25149432 Carneiro, J. R., & Sato, E. I. (1999). Double blind, randomized, placebo controlled clinical trial of methotrexate in systemic lupus erythematosus. The Journal of Rheumatology, 26(6), 1275–1279. PMID:10381042 Centers for Disease Control & Prevention. (2007). National and state medical expenditures and lost earnings attributable to arthritis and other rheumatic conditions--United States, 2003. MMWR. Morbidity and Mortality Weekly Report, 56(1), 4–7. PMID:17218935 Champion, J. A., & Mitragotri, S. (2006). Role of target geometry in phagocytosis. Proceedings of the National Academy of Sciences of the United States of America, 103(13), 4930–4934. doi:10.1073/ pnas.0600997103 PMID:16549762 Champion, J. A., Walker, A., & Mitragotri, S. (2008). Role of particle size in phagocytosis of polymeric microspheres. Pharmaceutical Research, 25(8), 1815–1821. doi:10.100711095-008-9562-y PMID:18373181 Chang, H. I., & Yeh, M. K. (2012). Clinical development of liposome-based drugs: Formulation, characterization, and therapeutic efficacy. International Journal of Nanomedicine, 7, 49–60. doi:10.2147/ IJN.S26766 PMID:22275822 Chen, H., Langer, R., & Edwards, D. A. (1997). A Film Tension Theory of Phagocytosis. Journal of Colloid and Interface Science, 190(1), 118–133. doi:10.1006/jcis.1997.4865 PMID:9241149 Chono, S., Tanino, T., Seki, T., & Morimoto, K. (2007). Uptake characteristics of liposomes by rat alveolar macrophages: Influence of particle size and surface mannose modification. The Journal of Pharmacy and Pharmacology, 59(1), 75–80. doi:10.1211/jpp.59.1.0010 PMID:17227623 Chun, J., & Hartung, H. P. (2010). Mechanism of action of oral fingolimod (FTY720) in multiple sclerosis. Clinical Neuropharmacology, 33(2), 91–101. doi:10.1097/WNF.0b013e3181cbf825 PMID:20061941 Cohen, J. A., & Chun, J. (2011). Mechanisms of fingolimod’s efficacy and adverse effects in multiple sclerosis. Annals of Neurology, 69(5), 759–777. doi:10.1002/ana.22426 PMID:21520239 Couto, D., Ribeiro, D., Freitas, M., Gomes, A., Lima, J. L., & Fernandes, E. (2010). Scavenging of reactive oxygen and nitrogen species by the prodrug sulfasalazine and its metabolites 5-aminosalicylic acid and sulfapyridine. Redox Report, 15(6), 259–267. doi:10.1179/135100010X12826446921707 PMID:21208525 Crofford, L. J. (2013). Use of NSAIDs in treating patients with arthritis. Arthritis Research & Therapy, 15(Suppl 3), S2. doi:10.1186/ar4174 PMID:24267197 Cunnane, G., Hummel, K. M., Muller-Ladner, U., Gay, R. E., & Gay, S. (1998). Mechanism of joint destruction in rheumatoid arthritis. Archivum Immunologiae et Therapiae Experimentalis, 46(1), 1–7. PMID:9510939

132

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Cutolo, M., Sulli, A., Pizzorni, C., Seriolo, B., & Straub, R. H. (2001). Anti-inflammatory mechanisms of methotrexate in rheumatoid arthritis. Annals of the Rheumatic Diseases, 60(8), 729–735. doi:10.1136/ ard.60.8.729 PMID:11454634 Czajkowsky, D. M., Hu, J., Shao, Z., & Pleass, R. J. (2012). Fc-fusion proteins: New developments and future perspectives. EMBO Molecular Medicine, 4(10), 1015–1028. doi:10.1002/emmm.201201379 PMID:22837174 Dall, T. M., Mann, S. E., Zhang, Y., Quick, W. W., Seifert, R. F., Martin, J., ... Zhang, S. (2009). Distinguishing the economic costs associated with type 1 and type 2 diabetes. Population Health Management, 12(2), 103–110. doi:10.1089/pop.2009.12203 PMID:19361253 Desreumaux, P., & Ghosh, S. (2006). Review article: Mode of action and delivery of 5-aminosalicylic acid - new evidence. Alimentary Pharmacology & Therapeutics, 24(Suppl 1), 2–9. doi:10.1111/j.13652036.2006.03069.x PMID:16939423 Dhib-Jalbut, S., & Marks, S. (2010). Interferon-beta mechanisms of action in multiple sclerosis. Neurology, 74(Suppl 1), S17–S24. doi:10.1212/WNL.0b013e3181c97d99 PMID:20038758 Di Marco, M., Shamsuddin, S., Razak, K. A., Aziz, A. A., Devaux, C., Borghi, E., ... Sadun, C. (2010). Overview of the main methods used to combine proteins with nanosystems: Absorption, bioconjugation, and encapsulation. International Journal of Nanomedicine, 5, 37–49. PMID:20161986 Dobrovolskaia, M. A., & McNeil, S. E. (2007). Immunological properties of engineered nanomaterials. Nature Nanotechnology, 2(8), 469–478. doi:10.1038/nnano.2007.223 PMID:18654343 Dreaden, E. C., Austin, L. A., Mackey, M. A., & El-Sayed, M. A. (2012). Size matters: Gold nanoparticles in targeted cancer drug delivery. Ther Deliv, 3(4), 457–478. doi:10.4155/tde.12.21 PMID:22834077 Duong, A. D., Sharma, S., Peine, K. J., Gupta, G., Satoskar, A. R., Bachelder, E. M., ... Ainslie, K. M. (2013). Electrospray encapsulation of toll-like receptor agonist resiquimod in polymer microparticles for the treatment of visceral leishmaniasis. Molecular Pharmaceutics, 10(3), 1045–1055. doi:10.1021/ mp3005098 PMID:23320733 English, C., & Aloi, J. J. (2015). New FDA-Approved Disease-Modifying Therapies for Multiple Sclerosis. Clinical Therapeutics, 37(4), 691–715. doi:10.1016/j.clinthera.2015.03.001 PMID:25846320 Faria, A. M., & Weiner, H. L. (2005). Oral tolerance. Immunological Reviews, 206(1), 232–259. doi:10.1111/j.0105-2896.2005.00280.x PMID:16048553 Feldmann, M., & Maini, R. N. (2001). Anti-TNF alpha therapy of rheumatoid arthritis: What have we learned? Annual Review of Immunology, 19(1), 163–196. doi:10.1146/annurev.immunol.19.1.163 PMID:11244034 Fleischer, D. M., Burks, A. W., Vickery, B. P., Scurlock, A. M., Wood, R. A., Jones, S. M., . . . Consortium of Food Allergy. (2013). Sublingual immunotherapy for peanut allergy: a randomized, doubleblind, placebo-controlled multicenter trial. J Allergy Clin Immunol, 131(1), 119-127. doi: 10.1016/j. jaci.2012.11.011

133

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Fox, R. I., Herrmann, M. L., Frangou, C. G., Wahl, G. M., Morris, R. E., Strand, V., & Kirschbaum, B. J. (1999). Mechanism of action for leflunomide in rheumatoid arthritis. Clinical Immunology (Orlando, Fla.), 93(3), 198–208. doi:10.1006/clim.1999.4777 PMID:10600330 Friese, M. A., Schattling, B., & Fugger, L. (2014). Mechanisms of neurodegeneration and axonal dysfunction in multiple sclerosis. Nat Rev Neurol, 10(4), 225–238. doi:10.1038/nrneurol.2014.37 PMID:24638138 Garris, C. S., Wu, L., Acharya, S., Arac, A., Blaho, V. A., Huang, Y., ... Han, M. H. (2013). Defective sphingosine 1-phosphate receptor 1 (S1P1) phosphorylation exacerbates TH17-mediated autoimmune neuroinflammation. Nature Immunology, 14(11), 1166–1172. doi:10.1038/ni.2730 PMID:24076635 Getts, D. R., Martin, A. J., McCarthy, D. P., Terry, R. L., Hunter, Z. N., Yap, W. T., ... Miller, S. D. (2012). Microparticles bearing encephalitogenic peptides induce T-cell tolerance and ameliorate experimental autoimmune encephalomyelitis. Nature Biotechnology, 30(12), 1217–1224. doi:10.1038/ nbt.2434 PMID:23159881 Gibofsky, A. (2012). Overview of epidemiology, pathophysiology, and diagnosis of rheumatoid arthritis. The American Journal of Managed Care, 18(13Suppl), S295–S302. PMID:23327517 Gupta, A. K., & Gupta, M. (2005). Synthesis and surface engineering of iron oxide nanoparticles for biomedical applications. Biomaterials, 26(18), 3995–4021. doi:10.1016/j.biomaterials.2004.10.012 PMID:15626447 Haraoui, B., & Bykerk, V. (2007). Etanercept in the treatment of rheumatoid arthritis. Ther Clin Risk Manag, 3(1), 99–105. doi:10.2147/tcrm.2007.3.1.99 PMID:18360618 Hawiger, D., Inaba, K., Dorsett, Y., Guo, M., Mahnke, K., Rivera, M., ... Nussenzweig, M. C. (2001). Dendritic cells induce peripheral T cell unresponsiveness under steady state conditions in vivo. The Journal of Experimental Medicine, 194(6), 769–779. doi:10.1084/jem.194.6.769 PMID:11560993 Herrero-Beaumont, G., Martinez Calatrava, M. J., & Castaneda, S. (2012). Abatacept mechanism of action: Concordance with its clinical profile. Reumatol Clin, 8(2), 78–83. doi:10.1016/j.reuma.2011.08.002 PMID:22104048 Hogquist, K. A., Baldwin, T. A., & Jameson, S. C. (2005). Central tolerance: Learning self-control in the thymus. Nature Reviews. Immunology, 5(10), 772–782. doi:10.1038/nri1707 PMID:16200080 Hunter, Z., McCarthy, D. P., Yap, W. T., Harp, C. T., Getts, D. R., Shea, L. D., & Miller, S. D. (2014). A biodegradable nanoparticle platform for the induction of antigen-specific immune tolerance for treatment of autoimmune disease. ACS Nano, 8(3), 2148–2160. doi:10.1021/nn405033r PMID:24559284 Hutchinson, M., Fox, R. J., Havrdova, E., Kurukulasuriya, N. C., Sarda, S. P., Agarwal, S., ... Deniz, B. (2014). Efficacy and safety of BG-12 (dimethyl fumarate) and other disease-modifying therapies for the treatment of relapsing-remitting multiple sclerosis: A systematic review and mixed treatment comparison. Current Medical Research and Opinion, 30(4), 613–627. doi:10.1185/03007995.2013.86 3755 PMID:24195574

134

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Johnson, K. P., Brooks, B. R., Ford, C. C., Goodman, A., Guarnaccia, J., Lisak, R. P., ... Wolinsky, J. S. (2000). Sustained clinical benefits of glatiramer acetate in relapsing multiple sclerosis patients observed for 6 years. Copolymer 1 Multiple Sclerosis Study Group. Multiple Sclerosis, 6(4), 255–266. doi:10.1177/135245850000600407 PMID:10962546 Karim, M. Y., Alba, P., Cuadrado, M. J., Abbs, I. C., D’Cruz, D. P., Khamashta, M. A., & Hughes, G. R. (2002). Mycophenolate mofetil for systemic lupus erythematosus refractory to other immunosuppressive agents. Rheumatology (Oxford, England), 41(8), 876–882. doi:10.1093/rheumatology/41.8.876 PMID:12154204 Kay, J., & Calabrese, L. (2004). The role of interleukin-1 in the pathogenesis of rheumatoid arthritis. Rheumatology (Oxford, England), 43(Suppl 3), iii2–iii9. doi:10.1093/rheumatology/keh201 PMID:15150426 Keselowsky, B. G., Xia, C. Q., & Clare-Salzler, M. (2011). Multifunctional dendritic cell-targeting polymeric microparticles: Engineering new vaccines for type 1 diabetes. Human Vaccines, 7(1), 37–44. doi:10.4161/hv.7.1.12916 PMID:21157186 Khadra, A., Tsai, S., Santamaria, P., & Edelstein-Keshet, L. (2010). On how monospecific memorylike autoregulatory CD8+ T cells can blunt diabetogenic autoimmunity: A computational approach. Journal of Immunology (Baltimore, MD.: 1950), 185(10), 5962–5972. doi:10.4049/jimmunol.1001306 PMID:20962260 Kipen, Y., Littlejohn, G. O., & Morand, E. F. (1997). Methotrexate use in systemic lupus erythematosus. Lupus, 6(4), 385–389. doi:10.1177/096120339700600407 PMID:9175024 Kontos, S., Kourtis, I. C., Dane, K. Y., & Hubbell, J. A. (2013). Engineering antigens for in situ erythrocyte binding induces T-cell deletion. Proceedings of the National Academy of Sciences of the United States of America, 110(1), E60–E68. doi:10.1073/pnas.1216353110 PMID:23248266 Krause, I., Blank, M., & Shoenfeld, Y. (2000). Immunomodulation of experimental autoimmune diseases via oral tolerance. Critical Reviews in Immunology, 20(1), 1–16. PMID:10770268 Labet, M., & Thielemans, W. (2009). Synthesis of polycaprolactone: A review. Chemical Society Reviews, 38(12), 3484–3504. doi:10.1039/b820162p PMID:20449064 Laouini, A., Charcosset, C., Fessi, H., Holdich, R. G., & Vladisavljevic, G. T. (2013). Preparation of liposomes: A novel application of microengineered membranes--from laboratory scale to large scale. Colloids and Surfaces. B, Biointerfaces, 112, 272–278. doi:10.1016/j.colsurfb.2013.07.066 PMID:23999143 Larochelle, C., Alvarez, J. I., & Prat, A. (2011). How do immune cells overcome the blood-brain barrier in multiple sclerosis? FEBS Letters, 585(23), 3770–3780. doi:10.1016/j.febslet.2011.04.066 PMID:21550344 Linker, R. A., & Gold, R. (2013). Dimethyl fumarate for treatment of multiple sclerosis: Mechanism of action, effectiveness, and side effects. Current Neurology and Neuroscience Reports, 13(11), 394. doi:10.100711910-013-0394-8 PMID:24061646 Longmire, M., Choyke, P. L., & Kobayashi, H. (2008). Clearance properties of nano-sized particles and molecules as imaging agents: Considerations and caveats. Nanomedicine (London), 3(5), 703–717. doi:10.2217/17435889.3.5.703 PMID:18817471

135

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Lopez-Olivo, M. A., Siddhanamatha, H. R., Shea, B., Tugwell, P., Wells, G. A., & Suarez-Almazor, M. E. (2014). Methotrexate for treating rheumatoid arthritis. Cochrane Database of Systematic Reviews, 6, CD000957. doi:10.1002/14651858.CD000957.pub2 PMID:24916606 Lu, L., Peter, S. J., Lyman, M. D., Lai, H. L., Leite, S. M., Tamada, J. A., ... Mikos, A. G. (2000). In vitro and in vivo degradation of porous poly(DL-lactic-co-glycolic acid) foams. Biomaterials, 21(18), 1837–1845. doi:10.1016/S0142-9612(00)00047-8 PMID:10919687 Lutterotti, A., Yousef, S., Sputtek, A., Sturner, K. H., Stellmann, J. P., Breiden, P., ... Martin, R. (2013). Antigen-specific tolerance by autologous myelin peptide-coupled cells: A phase 1 trial in multiple sclerosis. Science Translational Medicine, 5(188), 188ra175. doi:10.1126citranslmed.3006168 PMID:23740901 Maassen, C. B., Laman, J. D., van Holten-Neelen, C., Hoogteijling, L., Groenewegen, L., Visser, L., ... Claassen, E. (2003). Reduced experimental autoimmune encephalomyelitis after intranasal and oral administration of recombinant lactobacilli expressing myelin antigens. Vaccine, 21(32), 4685–4693. doi:10.1016/S0264-410X(03)00522-X PMID:14585676 Maetzel, A., Wong, A., Strand, V., Tugwell, P., Wells, G., & Bombardier, C. (2000). Meta-analysis of treatment termination rates among rheumatoid arthritis patients receiving disease-modifying antirheumatic drugs. Rheumatology (Oxford, England), 39(9), 975–981. doi:10.1093/rheumatology/39.9.975 PMID:10986302 Maldonado, R. A., LaMothe, R. A., Ferrari, J. D., Zhang, A. H., Rossi, R. J., Kolte, P. N., ... Kishimoto, T. K. (2015). Polymeric synthetic nanoparticles for the induction of antigen-specific immunological tolerance. Proceedings of the National Academy of Sciences of the United States of America, 112(2), E156–E165. doi:10.1073/pnas.1408686111 PMID:25548186 Maltzman, J. S., & Koretzky, G. A. (2003). Azathioprine: Old drug, new actions. The Journal of Clinical Investigation, 111(8), 1122–1124. doi:10.1172/JCI200318384 PMID:12697731 Manolova, V., Flace, A., Bauer, M., Schwarz, K., Saudan, P., & Bachmann, M. F. (2008). Nanoparticles target distinct dendritic cell populations according to their size. European Journal of Immunology, 38(5), 1404–1413. doi:10.1002/eji.200737984 PMID:18389478 McCarthy, D. P., Bryant, J., Galvin, J. P., Miller, S. D., & Luo, X. (2015). Tempering allorecognition to induce transplant tolerance with chemically modified apoptotic donor cells. American Journal of Transplantation, 15(6), 1475–1483. doi:10.1111/ajt.13237 PMID:25807873 McGaha, T. L., Chen, Y., Ravishankar, B., van Rooijen, N., & Karlsson, M. C. (2011). Marginal zone macrophages suppress innate and adaptive immunity to apoptotic cells in the spleen. Blood, 117(20), 5403–5412. doi:10.1182/blood-2010-11-320028 PMID:21444914 Md Yusof, M. Y., & Emery, P. (2013). Targeting interleukin-6 in rheumatoid arthritis. Drugs, 73(4), 341–356. doi:10.100740265-013-0018-2 PMID:23456676 Miller, S. D., & Karpus, W. J. (2007). Experimental autoimmune encephalomyelitis in the mouse. Curr Protoc Immunol. doi:10.1002/0471142735.im1501s77

136

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Moghimi, S. M., Hunter, A. C., & Andresen, T. L. (2012). Factors controlling nanoparticle pharmacokinetics: An integrated analysis and perspective. Annual Review of Pharmacology and Toxicology, 52(1), 481–503. doi:10.1146/annurev-pharmtox-010611-134623 PMID:22035254 Mohan, C., & Putterman, C. (2015). Genetics and pathogenesis of systemic lupus erythematosus and lupus nephritis. Nature Reviews. Nephrology, 11(6), 329–341. doi:10.1038/nrneph.2015.33 PMID:25825084 Mok, C. C., & Lau, C. S. (2003). Pathogenesis of systemic lupus erythematosus. Journal of Clinical Pathology, 56(7), 481–490. doi:10.1136/jcp.56.7.481 PMID:12835292 Nicholson, L. B., Murtaza, A., Hafler, B. P., Sette, A., & Kuchroo, V. K. (1997). A T cell receptor antagonist peptide induces T cells that mediate bystander suppression and prevent autoimmune encephalomyelitis induced with multiple myelin antigens. Proceedings of the National Academy of Sciences of the United States of America, 94(17), 9279–9284. doi:10.1073/pnas.94.17.9279 PMID:9256473 Nounou, M. M., El-Khordagui, L. K., & Khalafallah, N. (2005). Release stability of 5-fluorouracil liposomal concentrates, gels and lyophilized powder. Acta Poloniae Pharmaceutica, 62(5), 381–391. PMID:16459487 Oh, J., & O’Connor, P. W. (2014). Teriflunomide in the treatment of multiple sclerosis: Current evidence and future prospects. Ther Adv Neurol Disord, 7(5), 239–252. doi:10.1177/1756285614546855 PMID:25342978 Oh, N., & Park, J. H. (2014). Endocytosis and exocytosis of nanoparticles in mammalian cells. International Journal of Nanomedicine, 9(Suppl 1), 51–63. doi:10.2147/IJN.S26592 PMID:24872703 Orban, T., Bundy, B., Becker, D. J., DiMeglio, L. A., Gitelman, S. E., Goland, R., ... Skyler, J. S. (2011). Co-stimulation modulation with abatacept in patients with recent-onset type 1 diabetes: A randomised, double-blind, placebo-controlled trial. Lancet, 378(9789), 412–419. doi:10.1016/S0140-6736(11)608866 PMID:21719096 Pacholczyk, R., & Kern, J. (2008). The T-cell receptor repertoire of regulatory T cells. Immunology, 125(4), 450–458. doi:10.1111/j.1365-2567.2008.02992.x PMID:19128356 Peakman, M., & Dayan, C. M. (2001). Antigen-specific immunotherapy for autoimmune disease: Fighting fire with fire? Immunology, 104(4), 361–366. doi:10.1046/j.1365-2567.2001.01335.x PMID:11899420 Peine, K. J., Guerau-de-Arellano, M., Lee, P., Kanthamneni, N., Severin, M., Probst, G. D., ... Ainslie, K. M. (2014). Treatment of experimental autoimmune encephalomyelitis by codelivery of disease associated Peptide and dexamethasone in acetalated dextran microparticles. Molecular Pharmaceutics, 11(3), 828–835. doi:10.1021/mp4005172 PMID:24433027 Peng, H., Guerau-de-Arellano, M., Mehta, V. B., Yang, Y., Huss, D. J., Papenfuss, T. L., ... Racke, M. K. (2012). Dimethyl fumarate inhibits dendritic cell maturation via nuclear factor kappaB (NF-kappaB) and extracellular signal-regulated kinase 1 and 2 (ERK1/2) and mitogen stress-activated kinase 1 (MSK1) signaling. The Journal of Biological Chemistry, 287(33), 28017–28026. doi:10.1074/jbc.M112.383380 PMID:22733812

137

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Peng, H. J., Chang, Z. N., Lin, S. Y., Han, S. H., & Chang, C. H. (1998). Chemical denaturation of ovalbumin abrogates the induction of oral tolerance of mouse reaginic antibody responses. Scandinavian Journal of Immunology, 47(5), 475–480. doi:10.1046/j.1365-3083.1998.00333.x PMID:9627132 Peng, H. J., Chang, Z. N., Tsai, L. C., Su, S. N., Shen, H. D., & Chang, C. H. (1998). Heat denaturation of egg-white proteins abrogates the induction of oral tolerance of specific Th2 immune responses in mice. Scandinavian Journal of Immunology, 48(5), 491–496. doi:10.1046/j.1365-3083.1998.00432.x PMID:9822257 Perkins, M. R., Ryschkewitsch, C., Liebner, J. C., Monaco, M. C., Himelfarb, D., Ireland, S., ... Douek, D. C. (2012). Changes in JC virus-specific T cell responses during natalizumab treatment and in natalizumab-associated progressive multifocal leukoencephalopathy. PLoS Pathogens, 8(11), e1003014. doi:10.1371/journal.ppat.1003014 PMID:23144619 Petri, M. (2004). Cyclophosphamide: New approaches for systemic lupus erythematosus. Lupus, 13(5), 366–371. doi:10.1191/0961203303lu1028oa PMID:15230294 Pisoni, C. N., & D’Cruz, D. P. (2008). The safety of mycophenolate mofetil in pregnancy. Expert Opinion on Drug Safety, 7(3), 219–222. doi:10.1517/14740338.7.3.219 PMID:18462179 Quan, L. D., Thiele, G. M., Tian, J., & Wang, D. (2008). The Development of Novel Therapies for Rheumatoid Arthritis. Expert Opin Ther Pat, 18(7), 723–738. doi:10.1517/13543776.18.7.723 PMID:19578469 Reindl, M., Di Pauli, F., Rostasy, K., & Berger, T. (2013). The spectrum of MOG autoantibody-associated demyelinating diseases. Nat Rev Neurol, 9(8), 455–461. doi:10.1038/nrneurol.2013.118 PMID:23797245 Ricciotti, E., & FitzGerald, G. A. (2011). Prostaglandins and inflammation. Arteriosclerosis, Thrombosis, and Vascular Biology, 31(5), 986–1000. doi:10.1161/ATVBAHA.110.207449 PMID:21508345 Ruckemann, K., Fairbanks, L. D., Carrey, E. A., Hawrylowicz, C. M., Richards, D. F., Kirschbaum, B., & Simmonds, H. A. (1998). Leflunomide inhibits pyrimidine de novo synthesis in mitogen-stimulated T-lymphocytes from healthy humans. The Journal of Biological Chemistry, 273(34), 21682–21691. doi:10.1074/jbc.273.34.21682 PMID:9705303 Ruggieri, R. M., Settipani, N., Viviano, L., Attanasio, M., Giglia, L., Almasio, P., ... Piccoli, F. (2003). Long-term interferon-beta treatment for multiple sclerosis. Neurological Sciences, 24(5), 361–364. doi:10.100710072-003-0190-3 PMID:14716534 Saklayen, M. G., Pesce, A. J., Pollak, V. E., & Michael, J. G. (1984). Kinetics of oral tolerance: Study of variables affecting tolerance induced by oral administration of antigen. International Archives of Allergy and Applied Immunology, 73(1), 5–9. doi:10.1159/000233428 PMID:6693181 Savjani, K. T., Gajjar, A. K., & Savjani, J. K. (2012). Drug solubility: Importance and enhancement techniques. ISRN Pharm, 195727. doi:10.5402/2012/195727 PMID:22830056 Selewski, Segal, Rajdev, & Mukherji. (2010). Natalizumab (Tysabri). American Journal of Neuroradiology.

138

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Shirani, A., Zhao, Y., Karim, M. E., Evans, C., Kingwell, E., van der Kop, M. L., ... Tremlett, H. (2012). Association between use of interferon beta and progression of disability in patients with relapsing-remitting multiple sclerosis. Journal of the American Medical Association, 308(3), 247–256. doi:10.1001/ jama.2012.7625 PMID:22797642 Smith, K. J., & McDonald, W. I. (1999). The pathophysiology of multiple sclerosis: The mechanisms underlying the production of symptoms and the natural history of the disease. Philosophical Transactions of the Royal Society of London. Series B, Biological Sciences, 354(1390), 1649–1673. doi:10.1098/ rstb.1999.0510 PMID:10603618 Tabata, Y., & Ikada, Y. (1988). Effect of the size and surface charge of polymer microspheres on their phagocytosis by macrophage. Biomaterials, 9(4), 356–362. doi:10.1016/0142-9612(88)90033-6 PMID:3214660 Taylor, P. A., Friedman, T. M., Korngold, R., Noelle, R. J., & Blazar, B. R. (2002). Tolerance induction of alloreactive T cells via ex vivo blockade of the CD40:CD40L costimulatory pathway results in the generation of a potent immune regulatory cell. Blood, 99(12), 4601–4609. doi:10.1182/blood. V99.12.4601 PMID:12036894 Tsai, S., Shameli, A., Yamanouchi, J., Clemente-Casares, X., Wang, J., Serra, P., ... Santamaria, P. (2010). Reversal of autoimmunity by boosting memory-like autoregulatory T cells. Immunity, 32(4), 568–580. doi:10.1016/j.immuni.2010.03.015 PMID:20381385 Vallittu, A. M., Peltoniemi, J., Elovaara, I., Kuusisto, H., Farkkila, M., Multanen, J., & Eralinna, J. P. (2005). The efficacy of glatiramer acetate in beta-interferon-intolerant MS patients. Acta Neurologica Scandinavica, 112(4), 234–237. doi:10.1111/j.1600-0404.2005.00464.x PMID:16146492 Van Belle, T. L., Taylor, P., & von Herrath, M. G. (2009). Mouse Models for Type 1 Diabetes. Drug Discovery Today. Disease Models, 6(2), 41–45. doi:10.1016/j.ddmod.2009.03.008 PMID:20407588 Vesterinen, H. M., Sena, E. S., ffrench-Constant, C., Williams, A., Chandran, S., & Macleod, M. R. (2010). Improving the translational hit of experimental treatments in multiple sclerosis. Multiple Sclerosis, 16(9), 1044–1055. doi:10.1177/1352458510379612 PMID:20685763 Vilar, G., Tulla-Puche, J., & Albericio, F. (2012). Polymers and drug delivery systems. Current Drug Delivery, 9(4), 367–394. doi:10.2174/156720112801323053 PMID:22640038 Wang, S., Zhang, X., Zhang, L., Bryant, J., Kheradmand, T., Hering, B. J., ... Luo, X. (2014). Preemptive Tolerogenic Delivery of Donor Antigens for Permanent Allogeneic Islet Graft Protection. Cell Transplantation. doi:10.3727/096368914X681027 PMID:24759564 Weiner, H. L. (2000). Oral tolerance, an active immunologic process mediated by multiple mechanisms. The Journal of Clinical Investigation, 106(8), 935–937. doi:10.1172/JCI11348 PMID:11032852 Wu, G. C., Xu, X. D., Huang, Q., & Wu, H. (2013). Leflunomide: Friend or foe for systemic lupus erythematosus? Rheumatology International, 33(2), 273–276. doi:10.100700296-012-2508-z PMID:22961090 Xing, Y., & Hogquist, K. A. (2012). T-cell tolerance: Central and peripheral. Cold Spring Harbor Perspectives in Biology, 4(6), a006957. doi:10.1101/cshperspect.a006957 PMID:22661634

139

 Drug Delivery Strategies for Tolerogenic Therapy for Autoimmune Diseases in an Antigen-Specific Manner

Yamano, T., Watanabe, S., Hasegawa, H., Suzuki, T., Abe, R., Tahara, H., ... Kishimoto, H. (2011). Ex vivo-expanded DCs induce donor-specific central and peripheral tolerance and prolong the acceptance of donor skin grafts. Blood, 117(9), 2640–2648. doi:10.1182/blood-2010-07-293860 PMID:21220748 Yeste, A., Nadeau, M., Burns, E. J., Weiner, H. L., & Quintana, F. J. (2012). Nanoparticle-mediated codelivery of myelin antigen and a tolerogenic small molecule suppresses experimental autoimmune encephalomyelitis. Proceedings of the National Academy of Sciences of the United States of America, 109(28), 11270–11275. doi:10.1073/pnas.1120611109 PMID:22745170 Zhang, A. H., Skupsky, J., & Scott, D. W. (2009). Factor VIII inhibitors: Risk factors and methods for prevention and immune modulation. Clinical Reviews in Allergy & Immunology, 37(2), 114–124. doi:10.100712016-009-8122-5 PMID:19199081 Zheng, S. G., Wang, J. H., Koss, M. N., Quismorio, F. Jr, Gray, J. D., & Horwitz, D. A. (2004). CD4+ and CD8+ regulatory T cells generated ex vivo with IL-2 and TGF-beta suppress a stimulatory graftversus-host disease with a lupus-like syndrome. Journal of Immunology (Baltimore, MD.: 1950), 172(3), 1531–1539. doi:10.4049/jimmunol.172.3.1531 PMID:14734731 Ziemssen, T., & Schrempf, W. (2007). Glatiramer acetate: Mechanisms of action in multiple sclerosis. International Review of Neurobiology, 79, 537–570. doi:10.1016/S0074-7742(07)79024-4 PMID:17531858 Zonana-Nacach, A., Barr, S. G., Magder, L. S., & Petri, M. (2000). Damage in systemic lupus erythematosus and its association with corticosteroids. Arthritis and Rheumatism, 43(8), 1801–1808. doi:10.1002/1529-0131(200008)43:83.0.CO;2-O PMID:10943870

This research was previously published in Recent Advances in Drug Delivery Technology edited by Raj K. Keservani, Anil K. Sharma, and Rajesh Kumar Kesharwani, pages 23-51, copyright year 2017 by Medical Information Science Reference (an imprint of IGI Global).

140

141

Chapter 8

HIV/AIDS Discrimination, Stigmatization, and Denial: A Study in Social Work Perspective Yatendra Pal Singh Lucknow University, India

ABSTRACT Everyday number of new cases of Human Immunodeficiency Virus (HIV) and Acquired Immuno-Deficiency Syndrome AIDS is coming out in the society. HIV positives face discrimination and stigmatization everywhere in the society because firstly it is ill defined and secondly there is no cure or treatment for. People living with HIV/AIDS continue to be rejected by friends and relatives; fired or forced to resign from their jobs and subjected to violent assault (Herrek, 1990). Social Work exists because it fulfills crucial social needs. Social work serves people and society where there is malfunctioning or inadequacy. Social Work Education includes several tools and techniques to prevent problems through diagnosing causes responsible for maladjustment in society for contributing global peace in the world. The present chapter throws light on- 1. The problems face by HIV Positives and AIDS Patients. 2. Role of Social Work Education for minimizing or removing stress of HIV Positives and AIDS Patients for contributing to Global Peace.

INTRODUCTION In the words of Deshmukh (1954), “India’s declared objective is the attainment of a welfare state that means that we shall steadily strive to work to bring about conditions of life that will assure every citizen freedom from want and a fair share of the necessities of life.” In our Indian constitution too Article 21, a Fundamental Right states that no person shall be deprived of his life or personal liberty except according to procedure established by law. Article 47 directs the government to improve public health stating: “The State shall regard the raising of the level of nutrition and the standard of living of its people and the improvement of public health as among its primary duties.” The social work concept is also based on the same principles that grew out of humanitarian and democratic ideals and its values are based on respect for the equality, worth and dignity of all people living in the society. Human Rights and Social Justice DOI: 10.4018/978-1-5225-7122-3.ch008

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 HIV/AIDS Discrimination, Stigmatization, and Denial

serve as the motivation, inspiration and justification for social work action. In solidarity with those who are disadvantaged, the social work profession strives to alleviate poverty and to liberate vulnerable and oppressed people, especially women and children, in order to promote social inclusion. Social Work Profession helps in addressing the barriers, inequalities and injustices that exist in society. Its mission is to help people to develop their full potential, enrich their lives in such a way that they can help themselves. Undoubtedly the social changes which social work has had to accommodate- changing demographic structures; increased poverty, exclusion and disadvantage and the inter-nationalization of social problems will continue in the future to impact on social work. On the same way professional social work witnessed numberless competing and potentially conflicting ideologies.

HIV/AIDS: An Inevitable Fact There is not a single nation remained free from the cruel clutches of Human Immunodeficiency Virus(HIV). In the present scenario, problems that remained unattended are increased surpassing the limits and time in the number of people living in poverty, a rising juvenile delinquency status, unaffordable for workers and poor people, a serious backlash against illegal immigration, laws to protect us against terrorism that often limit our social liberties and a potential shortfall in social security and Medicare funding for pandemic like Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS), Ebola, Swine flue, Tuberculosis and other occasional diseases. Tanzima Zohra Habib and Mohd. Siddiqui Rahman (2010) observes that illness is an inevitable fact of human life. Man cannot live in a vacuum. Therefore, like all other events of him, illness is influenced by socio-cultural as well as biological factors. Illness refers to biological, psychological or social conditions that are often understandable in a social or cultural context. Hence illness and death comes to all. Ironically, AIDS is a kind of chronic illness that not only ends with the termination of life but also has a long term impact on the day to day living of the patient and his family and that can make the person physically, psychologically and socially disabled. AIDS is a particularly deadly disease, an illness with a fatal end that destroy a person’s immunity against infection, thereby leaving the individual defenseless against a variety of afflictions like cancer, pneumonia, tuberculosis and a host of viruses. Currently there is no treatment for HIV/AIDS and it is clearly progressive and always remains fatal. The expectation of permanent loss of the loved one can make it extremely difficult for a family to maintain a balance perspective. HIV/AIDS is a behavior-based disease. However it is not spread only by the behavior of those engaging in high-risk activities. It is spread also by the discriminatory behavior of people and governments towards the victims.

Epidemiological Scenario of HIV/AIDS In India the first reported case of HIV infection diagnosed were among Commercial Sex Workers (CSW), Female Sex Worker (FSW) in Madras in May 1986. The Annual Report 2013-2014 of NACO, the Department of AIDS Control (DAC), Government of India, reviews that India has the third highest number of estimated people living with HIV in the world. According to the HIV Estimations 2012, the estimated number of people living with HIV/AIDS in India was 20.89 lakh, with an estimated adult (15-49 age group) HIV prevalence of 0.27% in 2011. India has demonstrated an overall reduction of 57% in the annual new HIV infections among adult population from 2.74 lakh in 2000 to 1.16 lakh in 2011, reflecting the impact of various interventions and scaled-up prevention strategies under the National AIDS Control Programme (NACP). Sexually transmitted infections (STI) are a serious adolescent health 142

 HIV/AIDS Discrimination, Stigmatization, and Denial

problem. Approximately one-fourth of all sexually active adolescents will contract a sexually transmitted infection (Centers for Disease Control and Prevention, 2002). Child prostitution may be caused by interplay of factors like economic, social, cultural, physical, physiological, emotional and psychological. All over the world the child’s vulnerability to commercial sexual exploitation lies in family circumstances. The majority of sexually exploited children are either from marginalized families in the cities and destitute families in the country or children already in the sex industry. Priya Banerjee and Courtney Mattle (2005) found that there are many classifications of HIV/AIDS epidemic in India. Typically, these classifications are determined by location or modality of transmission. In the same way Col. Zile Singh and Lt. Col. A Banerjee (2004) in their study found that the social issues associated with AIDS can be understood in two ways- firstly they may refer to the social determinants of the pandemic. Secondly they relate to the social impact of the pandemic. Ethical question present some of the most vexing problems associated with HIV infection. NACO Annual Report 2011-12 discloses that HIV infection is transmitted from High Risk Groups (HRGs) to General Population through Bridge Population who constitutes major proportion of the clients of sex workers, such as truckers and migrants. The key risk groups covered through Targeted Intervention (TI) Program include: 1. High Risk Groups (HRGs): ◦◦ Female Sex Workers (FSW). ◦◦ Men who have sex with men (MSM). ◦◦ Transgender (TG). ◦◦ Injecting Drug Users (IDU). 2. Bridge Population: ◦◦ Truckers. ◦◦ Migrants.

Severe Negativity Around HIV Positives After initial shock and panic reaction, vigorous efforts were made to meet the challenge posed by HIV Positives within a short period of a decade, global and national epidemiological data on the magnitude and type of problems associated with HIV infection obtained for analyzing to reach a conclusion. Efforts made are under way to evolve and implement logical data on the magnitude and type of problems associated with HIV infection (ICMR Bulletin 1991). Epidemiological data have shown that undetected asymptomatic individuals play a major role in transmission of infection. Therefore, health education to the ‘at risk’ groups as well as to the general population and the strengthening of infection control measures in health care delivery system are matter of utmost importance for controlling AIDS (ICMR Bulletin April 1990). Agra Group of Network for Positive People a local Non-Government Organization in Agra works in coordination with Uttar Pradesh State AIDS Control Society, Lucknow has registered 1670 HIV Positives taking Antiretroviral Therapy (ART) till March 2015. The Project Co-ordinator AGNP, is of opinion that there is great downfall in the number of HIV/AIDS patients registered in his NGO in the last years. He believes that it is because of awareness and education spreading by various means of instruments at various levels. For HIV/AIDS patients there are total 6 Integrated Counseling and Testing Centre 143

 HIV/AIDS Discrimination, Stigmatization, and Denial

(ICTC) and 2 Prevention of Parent to Child Transmission (PPTC) and only Antiretroviral Therapy Centre (ARTC) are working in Agra District. Discrimination, Stigmatization and Denial are the expected outcome of such values affecting life in families, communities, work places, schools and health care settings of HIV Positives and AIDS patients. UNAIDS also found that HIV/AIDS related discrimination, Stigmatization and Denial in India is in some respect gendered phenomena. Women are often blamed by their parents and in-laws for infecting their husbands, for not controlling their partners; urges to have sex with other women. Children of HIV positive parents, whether positive or negative are often denied the right to go to school or separated from other children Sally Howes and Glynis Clasherty in their book HIV/AIDS Readers Teacher’s Guide clearly viewed about discrimination that children who are positives face in the society. Children living with HIV and AIDS or with families affected by HIV and AIDS are often stigmatized or isolated from their community and denied access to health services and school. The stigma is often worse for a person living with AIDS than the symptoms of sickness itself. In the classroom children might gang up against a child who is either infected or has a person living with AIDS in their family. The teacher’s role is to increase understanding and compassion and so lessen discrimination. You need to inform yourself and your learners.

Key Messages About Discrimination • • • •

Ignorance is the basis of discrimination, so teach the facts about HIV and AIDS! It is important to teach the facts about transmission because many children discriminate against others because of their fear of being infected. Children and adults living with or affected by HIV and AIDS need care and compassion; they should not be discriminated against. HIV and AIDS is a disease like many other diseases. Just because someone has HIV or AIDS it does not mean they are a bad person or that they have done wrong. Bullying is out.

It is important that we begin to see HIV and AIDS as a disease like any other disease and not discriminate against people who are HIV-positive. We know that one of the most powerful forms of education about HIV and AIDS is openness. When people disclose their status to family and community it creates a climate of open discussion and this reduces stigma. Obviously there are all sorts of things to be kept in mind when a person discloses their status but we also know that disclosure to at least trusted family members reduces stress for people who are HIV-positive and it gives them the support they need to cope with the disease. You can normalise HIV and AIDS by talking openly about it in your classroom. In a study Jyoti Kakkar(2011) showed that even after three decades of its detection the HIV continues to bring more and more population groups in its ambit. Work place stigma and discrimination issues have also received the attention of researchers. Rao and others(2008) in a qualitative study with hundred employees have shown that both biological and social stigma is prevalent in workplaces in Beiging, Hongkong and Chicago. In all the three cities, employers expressed their reluctance to recruit people who were infected with HIV. This has been shown to be a hindrance in programme implementation in the case of these industries. An International Labour Organization(ILO) study on HIV/AIDS – related stigma and discrimination in India found that 32% of the HIV Positive respondents had faced discrimination within the health144

 HIV/AIDS Discrimination, Stigmatization, and Denial

care setting. Widespread discrimination against people living with HIV/AIDS was also identified in a UNAIDS study of healthcare settings in Bangalore and Mumbai(UNAID 2001). Reported forms of discrimination included: • • • • • • • • • • • • • • •

Refusal to provide treatment for HIV/AIDS- related illness; Refusal to admit for hospital care/treatment/refusal to operate or assist in clinical procedures; Restricted access to facilities like toilets and common eating and drinking utensils; physical isolation in the ward(e.g. separate arrangements for a bed outside the ward in a gallery or corridor); Cessation of ongoing treatment; Early discharge from hospital; Mandatory testing for HIV before surgery and during pregnancy; Restrictions on movement around the ward or room; Unnecessary use of protective gear (gowns, masks etc.) by health care staff; Refusal to lift or touch the dead body of an HIV-positive person; Use of plastic sheeting to wrap the dead body; Reluctance to provide transport for the body; as well as more covert forms of discrimination, including; Delays in treatment; Shunting patient between wards/doctors/hospitals; Keeping patient under observation without any treatment plan; Unnecessarily repeated HIV tests.

The most commonly cited reason for denial of care was the high risk associated with provision of treatment. Amongst healthcare professionals as a whole, doctors, and particularly senior doctors, were considered most likely to discriminate. Thus people living with HIV/AIDS continue to be burdened by poor care and inadequate services. The author had a different opinion he stressed that people have lost jobs, been thrown out of residences and schools and been denied services they desperately needed. Even their most of the family members misbehaved with them by commenting or criticizing and they do not want to talk to them. Physicians and other health care professionals have refused to serve people with HIV/AIDS. Even morticians have refused to prepare the bodies for burial.

SOCIAL WORK: STRATEGIC INTERVENTIONS There have long been debates about the relationship between the supportive, caring and enabling elements of social work and the need at times to exercise powers of removal or control for the protection of the individual, other family members or the public at large. There are three levels of intervention: •

Macro Level: It involves society or communities as a whole. It includes policy forming and advocacy on a national or international scale. NACO in most of the countries of the world perform its role at this level.

145

 HIV/AIDS Discrimination, Stigmatization, and Denial

•

•

Mezzo Level: It involves work with agencies, small organizations, and other small groups. This level of practice would include policy making within a social work agency or developing programs for a particular neighborhood. SACS in various states and UT work for obtaining the purpose of NACO in coordination with the health policies of Central and State Government. Micro Level: This type of social work level involves service to individuals and families. NonGovernment Organizations/Voluntary Organizations work in direction of NACO in coordination with the District, State and National level in general.

There are number of Professional Associations for social workers which train, guide and motivate the social worker for well-being of the society. The purpose of these associations is to provide ethical guidance and other forms of support for their members and social workers in general. Professional Social Work is basically focused on problem solving and change. These includes counseling, clinical social work, group work, social pedagogical work, and family treatment and therapy, as well as efforts to help people obtain services and resources in the community. Interventions also include agency administration, community organization and engaging in social and political action to impact social policy and economic development (Hare, 2004, pp 418-420) The standards go on to outline the multiple objectives of social work as follows: • • • • • •

To enhance human wellbeing and alleviate poverty, oppression and social injustice. To enhance the social functioning and interactions of individual families, groups, organizations and communities. To formulate and implement social policies, services and programs. To pursue policies, services and resources through advocacy and socio-political actions. To develop and use research, knowledge and skills that advance social work practice. To develop and apply practice in the context of diverse culture.

Social work profession promotes social change positively, problem solving in human relationships and the improvement and liberation of people to enhance well-being. Utilizing theories of human behavior and social system, social work intervenes at the points where people interact with their environments. Principles of human rights and social justice are fundamental to social work (IASSW 2001). Social Work is an interrelated system of values, norms, theory and practice. Social Work practice mainly sees society as a laboratory and social workers work with individuals helping them to help themselves. Social Work focuses lives and prevents dysfunction. Thus social workers are change agents in society and in the lives of the individuals, families and communities. The profession of Social Work covers many practice areas involving a continuum of client systems. They may be individuals, families, groups, organizations and communities or combinations of any of these systems. The profession is committed to the value of service and social justice. Social work upholds the dignity and worth of the individual and emphasizes the importance of human relationships, integrity and competence. These values differentiate social work from all other professions. Social work utilizes a variety of skills, techniques and activities consistent with its holistic focus on persons and their environments social work interventions range from primary person focused psycho-social processes to involvement in social policy, planning and development (Anupama Hazara April 2011). The professional social work has its premises within which it approaches six methods in combating with this pandemic within the society. These methods are: 146

 HIV/AIDS Discrimination, Stigmatization, and Denial

1. 2. 3. 4. 5. 6.

Social Case Work. Social Group Work. Community Organization. Social Action. Social Work Research. Social Welfare Administration.

The first two methods i.e. social case work and social group work are largely being used in providing assistance to meet the needs of the HIV/AIDS patients. These two methods consist of programs which have direct contact with the individuals/groups facing the problems. However remaining other methods are being used in order to establish, maintain and operate social agencies which provide ways to social case work and group work services to assist the HIV/AIDS patients.

1. Social Case Work A professionally trained social case worker is able to go deep into the pain and sufferings of an HIV Positives and AIDS patient. He enables the client to face up to the problem by using the method of social case work counseling and Psychotherapy in chronical cases. The number of clients requiring social case work counseling is too high and the number of problems varied and many. In India, where 90 percent of female infections occur within marriage, women who stand up to their husbands are often shunned by their families. According to the 2010 report of the Joint United Nations Program on HIV/ AIDS (UNAIDS, 2010) sexual intercourse is the primary mode of HIV transmission in India, accounting for about 90 per cent of infected women acquired the virus from their husbands or intimate partners. The unequal status of women in most societies also makes them vulnerable to HIV infection. Gender inequities preclude the women on insisting the male to wear a condom even when she suspects him of high risk behavior. Our former prime-minister Dr. Man Mohan Singh on the occasion of 2nd East Asia Gender Equality Ministerial Meeting delivered speech that principles of gender equality and women’s rights are enshrined in our Constitution. It not only grants equality to women, but also advocates positive discrimination in favor of women, wherever necessary. These are reinforced through passage of new laws from time to time. A social work professional sensitizes surrounding HIV/AIDS programmes, there is an accepted need to consciously and continuously build stakeholder support. This end, most projects supported advocacy and psycho-social mobilization activities, customizing them to various stakeholders. Apart from empowering women with information on the prevention of this pandemic, they should also be given adequate training to act as peers and educators to the risk groups. Women counselors, attending on target populations, school and college girl students, pre-marital youth, housewives, working and non-working women, women of low socio-economic status and media-watchers, should be encouraged and provided sufficient back-up. The social case worker following the case work principle client selfdetermination assists the person and their family through the transition to higher levels of support needs, whether through the transition to higher levels of support needs, whether through increased disability, ill-health in order to access opportunities for independence and participation. Senegal (April 2000) presents an example of social work education in schools. A new initiative, Focusing Resources on Effective School Health (FRESH), launched at the World Education Forum in Dakar, and sponsored by the United Nations Educational, Scientific and Cultural Organization (UNESCO), the United Nations Children’s Fund (UNICEF), the World Health Organization (WHO) and the World Bank, signals the commitment 147

 HIV/AIDS Discrimination, Stigmatization, and Denial

of these agencies to assist national governments to implement school-based health programmes in efficient, realistic and results-oriented ways. The FRESH framework is based on agreement among the four collaborating agencies. Their belief is that there is a core group of cost-effective activities which, when implemented together, provide a sound basis and point of departure for intensified and joint action to make schools more healthy for children, children more able to learn, and Education for All more likely to be achieved. The Education for All initiative was launched in Jomtien, Thailand, in March 1990. With respect to the growing HIV pandemic, the four pillars of the FRESH approach are: • • • •

Clear school health policies on HIV and AIDS discrimination. A healthy environment. Skills-based education for the prevention of HIV. School-based counselling and student clubs for HIV prevention.

Implementing HIV and AIDS education programmes is similar to the introduction of any innovation within the school. Teachers may feel threatened, tested, concerned and uncomfortable in this new role. Beyond mastering new teaching techniques, they must, both as teachers and as individuals, deal with and overcome their own social feelings of discomfort, as well as their biases and prejudices. For educators to be able to teach human sexuality and HIV awareness and prevention to adolescents comfortably and competently it is necessary they be well trained, otherwise they will be at a disadvantage in providing accurate and meaningful information. Subject knowledge, skills and confidence are the most important factors in delivering good health education programme. Interacting with women journalists, on International Women’s Day on March 8th 2015, The Union Minister of Women and Child Development, Smt. Maneka Sanjay Gandhi on the issue of sex related crimes against women, said that Union Ministry of Women and Child Development is preparing a film on ‘Good Touch and Bad Touch’ to be shown in the schools so that the girls can learn to identify the difference between the two. Supportive Denial means that the client will not keep an awareness of his/ her condition in the forefront of his/her thoughts at all times (Shernoff 1998). Denial itself is neither bad nor good. If the client’s denial is so pervasive and intense that it impairs the PLWHAs’ reality testing, then the social case worker needs to challenge this denial. He supports the HIV positives in exercising their human and civil rights, including rights to privacy, family life freedom from enforced constraints and intervening in complex partnership of family situations to resolve relationship problems, conflicts of interest and damaging interaction affecting physical and mental health. Communication is the key to generate awareness on prevention as well as motivate access to testing, treatment, care and support. Most of the outcomes sought through social case work intervention are common to work with adults of working age, orphans, adolescent, physically handicapped, mentally retarded, older people and HIV positives and AIDS patients. In providing services, the professional social case worker should protect the confidentiality of clients’ written, oral and electronic records and other sensitive information.

2. Social Group Work Human beings do not live alone hence need a reciprocal give and take relationship. This is very much required especially in the time of need and on the crisis its expectations reaches high. In the present scenario, the HIV infected individuals are much in need of group help. In an HIV support group, group

148

 HIV/AIDS Discrimination, Stigmatization, and Denial

work focuses on the HIV infected individual in the group. The group itself is a platform where the HIV Positives are able to freely express themselves and share their problems and help one another. In India, there are very few HIV support groups. It is easier to help an HIV infected person to change his attitude for the rest of his life in a group setting than to change it through social case work counseling. Indian experience has demonstrated that HIV/AIDS prevention can work, by delaying the onset of sexual activity, reducing risk behaviors through Behavior Change Communication (BCC) and promoting safer sex. Most importantly, it has shown in many researches that new infections can be prevented. Dr Krishna Chandra Choudhary(2012) in her study describes that Indian Council of Medical Research (ICMR 1992) found that knowledge and awareness about puberty, menstruation, physical changes in the body, reproduction, contraception, pregnancy, childbearing, Reproductive Tract Infections (RTIs), Sexually Transmitted Infections (STIs), Sexually Transmitted Disease (STD) and HIV was low among boys, girls, especially in younger adolescents. Many of the projects confronted social norms and broke down barriers. Projects like the Adolescent Peer Organized Network (APON), Mhila Samakhya and the Girls Child Shield Programme reported that the girls and young women, who had received training, were more ambitious and confidant (K C Choudhary 2012). Innovative programs could be designed, presented and reviewed regularly. For adolescents, co-curricular activities are given greater importance. There are three major types of services, that is nothing but various approaches of social group work which are mostly found in colleges and universities i.e. Sports and Game, National Cadet Corps (NCC) and National Services Scheme (NSS). Through these service schemes students develop their personality in group activity. Aditi Bishnoi (2011)in her article ‘Facing Up to HIV in Shangri-la’ presents a perfect picture of social group work in Bhutanese society. In her study she showed that programme targeting children has a range of fun activities, from sponsored quiz competitions in district schools to encouraging local school children, theatre groups and popular singers, to put up skits and shows spreading the word like What is HIV? What happens when HIV infects a person? When a person has AIDS? These are some questions that are asked and answered repeatedly to get the right information across to young minds. Such dialogue episodes and plays/drama (Nukkad Natak), folk lore focusing the critical condition of HIV/AIDS patients reviews time time. It does not only spread awareness among general people but in strengthen HIV/AIDS patients emotionally and psychologically as well. One of the most important roles of the social group worker will be as liaison between the People living with HIV/AIDS (PLWHA) and his or her family, between the People living with HIV/AIDS (PLWHA) and physician or other health care providers and between social service agencies. In working with a stigmatized disease like HIV/AIDS, the social group worker should always apply the basic social work values: respect the worth of each individual and non-judgmental attitude. Peer educators, properly trained, supported and supervised, are an excellent way to deliver life skill based education. The influence of religion can also be seen in social work practices. Religion is nothing but duty. Pamela Philipose (Dec. 2011) depicted that an innovative strategy that evolved from the process was to involve religious leader in the effort to raise awareness. Iqbal Ahamad, executive director, Padakhep Manabik Unnayan Kendra viewed, “The idea is to get religious institutions in a conservative country like Bangladesh to take ownership of the campaign to prevent the spread of HIV/AIDS and end the stigma that those living with it have to face. Reid E (1993) reveals that “We need to reach out to each other as one human being to another. There can be no them and us if this epidemic is to be overcome. We are engaged upon a voyage of sharing, the sharing of a sense of mystery, of a burden of sadness, of the pain of care, of the laughter of life. It will be a voyage through pain, through the dark side of the epidemic, with hope.”

149

 HIV/AIDS Discrimination, Stigmatization, and Denial

3. Community Organization According to Friedlander, “Community Organization is the process of planning and developing social services in order to meet the health and welfare needs of a community or larger unit.” The community organizer guides the formation of action groups in the community using the discontent generated among the people in the community. The professional social worker in form of community organizer is well aware of the religious beliefs, social taboos, cultural ethos, negative family attitudes and lack of appropriate communication tools available within the community which are the principal obstacles to educate people in rural settings about AIDS. A professional social worker is the best person to successfully implement result oriented awareness campaigns in a community. For community sensitization the National Association of Social Workers (NASW) and Association of Social Work Boards published a set of ten standards regarding technology and social work practice, which serves as a guide for the social work profession to incorporate technology into various missions (NASW 2005). Renu Rakesh (Nov. 2008) in her article ‘What a Positive Mother!’ presents a perfect picture of a woman as a professional social worker playing the role as a Community Organizer also. The lady is able to become the foster mother of 10 HIV Positive children. Her name is Sushila. She and her husband Bitu Ram are neither people living with HIV/AIDS nor childless couple. So why has Sushila waged a lonely battle against stigma and discrimination for the sake of children orphaned by HIV/AIDS, even welcoming them into her two-room house in Jaipur.? Perhaps the answer lies in her heart – particulary when the orphans call her, “Ma.” Another incident of marriage of HIV positive couples had been made possible with the direction of Late Mr. Mukesh Kumar (name is disclosed after consent), then President, AGNP, an NGO working for HIV/AIDS in Agra. He witnessed many marriages in Uttar Pradesh. When he did anything for HIV/AIDS, he felt happiness and peace within him. As a friend he (Mr. Mukesh Kumar who was positive) shared several stories of discrimination faced by HIV positives and his efforts made to solve out the problems. When author used the word HIV patient, he stopped by correcting the word that HIV positive are not patient; remember (as guiding me) in contrast of Swine flue, HIV is less dangerous. It (Swine flue) takes the life in few days but HIV not. In the field of social work as a community organizer and a social activist, his life for HIV positive cannot be forgotten. Similarly in the case of Mr. Ram Singh (name is disclosed after consent), an employee in Central Government, the author surprised to meet with him when he disclosed himself that he has not been taking ART since last 14 years. He disclosed that he was under the treatment of a registered RMP doctor and taking medicines regularly. He was very conscious towards his health and hygiene. On asking the reason for not taking ART, he grew aggressive on the behavior in which Doctor and other staff of the hospital treated him. Nowadays he is in crisis; a sudden downfall in his health worried author while met him last in February 2015 at his home. He was thoroughly covered with the clothes and his face became pale with black shaded nails. He was worried of his daughter’s marriage in April 2015. Now, as an active community organizer he earns for his family and stand before every problems. His family members love him. He himself made aware of his family members regarding HIV/AIDS. Author salutes both the persons for their doings and struggle in the life. After conversation with HIV positives and AIDS patients, the author experienced that there is great need for communication and awareness in the society especially in the rural areas where most of the population have no knowledge about the pandemic. Information, Education and Communication are used as a weapon to combat the disease. NACO India annual report 2013-14 discloses that Communication is the

150

 HIV/AIDS Discrimination, Stigmatization, and Denial

key to generating awareness on prevention as well as motivating access to testing, treatment, care and support. With the launch of NACP IV, the impetus is on standardising the lessons learned during the third phase. Communication in NACP IV is directed: 1. 2. 3. 4.

To increase knowledge among general population (especially youth and women) on safe sexual behaviour. To sustain behaviour change in at risk populations (high risk groups and bridge populations). To generate demand for care, support and treatment services. To strengthen the enabling environment by facilitating appropriate changes in societal norms that reinforce positive attitudes, beliefs and practices to reduce stigma and discrimination

Elsa Mathews (2015) found that Naz Foundation, a New Delhi NGO working on HIV/AIDS and Sexual Health utilized an old but innovative use of games and sports that seek to empower girls through sport. Around 3000 girls are taking part in this campaign. A member of Kalyani Subramanyan of the Naz Foundation says, “Despite our best efforts to control HIV we realized that its incidence was high among women. This was because women and girls are not able to assert themselves in their private sphere, say ‘No’ to early marriages or unprotected sex. They were not able to raise their voice to continue their education. So we decided to use sport as a means of empowerment. It’s common to see boys playing in fields and Maidans in India but not girls. Our motive was to change this”. Folk media is a powerful medium of communication to disseminate difficult social message in rural areas. Integration of messages with local culture helps rural people to relate and respond easily. NACO has been conducting “Zindagi Zindabad” campaign using folk troups for information, dissemination at village level.

4. Social Welfare Administration Social Welfare Administration has twin concepts of Social Welfare and Administration embedded in it. Thus it requires an understanding of welfare and its origins as well as administration as a tool for achieving welfare. Social Welfare Administration is a process by which we apply professional competence to achieve certain goals. It is called a process of transforming social policy into social action. It is the process of planning, organizing and directing the activities of a social service agency. In providing services to the HIV positives and AIDS patients the social agencies have to shoulder a very major responsibility. Social worker should assess the socio-economic status of the PLWHA, their ethnicity, geographic location and most importantly the availability of social support which include interpersonal support, institutional support and also the community sentiment regarding HIV/AIDS. Interpersonal support includes family, friends and others in the community. Institutional supports include available, accessible, and affordable resources or services in the community such as medical or other health care services, health insurances etc. social workers need to develop and create connections with the social services to get appropriate help for the PLWHA. Social workers could use their status and professional expertise to advocate with the service providers in order to arrange a comprehensive care for the PLWHA. In September 2000, building upon a decade of major United Nations conference and summits, world leaders came together at the Organization’s Headquarters in Newyork and adopted the United Nations Millennium Declaration, a commitment by nations to a new global partnership to reduce extreme poverty which also set out a series of time bound targets-with a deadline of 2015- that have become known as the Millennium Development Goals (MDGs). These eight goals are: 151

 HIV/AIDS Discrimination, Stigmatization, and Denial

• • • • • • • •

Eradicate extreme poverty. Achieve universal primary education. Promote gender equality and empower women. Reduce child mortality. Improve maternal health. Combat HIV and AIDS, malaria and other diseases. Ensure environmental sustainability. Develop a global partnership for development.

The eight MDGs form a blueprint agreed to by all the countries and all the world’s leading development institution (Rakesh Chopra 2012). For achieving MDGs, there is an urgent need of critical dialogue between policy maker and people implementing it, so that the problematic aspects of policy can be challenged and modified. Finally social welfare administration supervise it antecedent steps like planning, organizing and direction of services. It checks and evaluates the programme and gives feedback to the policy makers. The Government in coordination and collaboration with other agencies should organize awareness campaign time to time. In the same way the Uttar Pradesh Government sponsored a campaing on 1st March 2015, a day-long event was organised by Uttar Pradesh Satate AIDS Contro Society (UPSACS) at MIRT Business College, Lucknow. The event was graced by Mr. Alok Ranjan, Chief Secretary of Uttar Pradesh and Mr. Alok Kumar, Project Director, UPSACS. The event comprised of various activities including an HIV/AIDS Awareness Workshop, followed by a Voluntary Blood Donation camp, a Quiz Competition on HIV/AIDS and cultural performances by youth teams from Nehru Yuva Kendras. The significance of the programme was to spread awareness on healthy living and awareness on HIV prevention. A number of youth came forward to donate blood(NACO News 2015).

5. Social Work Research Social work research is a systematic, critical and careful investigation of a social problem with an effort to find relevant information around the issue. For the effective implementation of any HIV/AIDS related program initiative, the role of social work research is as important as any other scientific and medical research. A social worker is the most ideal person to assess these social issues, the type of people most affected or vulnerable and suggest the most appropriate action plan which is effective and acceptable to the community. There is a clear need to establish a research agenda for stigma related to HIV. Stigma is a social phenomenon so needs to be understood at both individual and social levels. This work can lay the basis for directed campaigns and interventions against the practice of discrimination (D Skinner, S M Fecane 2004). T Trengrove Jones (1996) opines that the stigma towards people with AIDS is related to the incidence of all other kinds of stigma. So campaigns need to address or make space for changes of attitudes and beliefs about stigma based on race, gender, sexual orientation, physical illness or disability and class, amongst others. This was supported by a call from Kofi Annan, UN Secretary General, at the World Conference against Racism, where he made a combined call to end racism and discrimination against people living with AIDS. Input from social research field is urgently needed for planning and evaluation of AIDS prevention programs. Social, behavioral and legal research will improve understanding of the dynamics of the pandemic and its impact. It will translate in to public health and societal action for fostering understanding of the intricate relationships between individual, public

152

 HIV/AIDS Discrimination, Stigmatization, and Denial

health and society. It will also help in resolving some of the complex social and ethical issues. Brian E. Perron and other (2010) suggested that social work researchers and practitioners should work in earnest to document both the successful and unsuccessful initiatives involving Information and Communication Technologies in the field. Case examples can provide the basis for understanding how Information and Communication Technology can be integrated to enhance various aspects of the process. Unfortunately, the current method of disseminating new information and practice is primarily through professional journals, where the general timeline of an article (the time it takes to have a manuscript submitted, reviewed, and subsequently published) will likely not be quick enough to keep up with the advances in technology. It behooved the field of social work to explore options to connect with other researchers and practitioners to share knowledge, particularly with social media. The role of research can be imagined by only that on the basis of social survey and scientific research The Government of India launched National AIDS Control Programme (NACP). NACP-I: In 1992, the Government of India launched of the first National AIDS Control Programme (NACP-I) as a comprehensive programme for prevention and control of HIV/AIDS in India. The programme, implemented during 1992-1999 to strengthen the management capacity, a National AIDS Control Board (NACB) was constituted and an autonomous National AIDS Control Organisation (NACO) set up for project implementation. NACP-II: In November 1999, the second National AIDS Control Programme (NACP-II 1999-2007) was launched. NACP-III: The third phase of National AIDS Control Programme (NACP- III), implemented during 2007-2012, was a scientifically wellevolved programme, grounded on a strong structure of policies, programmes, schemes, operational guidelines, rules and norms. NACP-IV: Consolidating the gains made till now, the fourth phase of National AIDS Control Programme (NACP-IV) under the Department of AIDS Control aims to accelerate the process of epidemic reversal and further strengthen the epidemic response in India through a cautious and well-defined integration process over the period 2012-2017. NACP-IV will focus on intensifying and consolidating prevention services with a focus on high risk groups and vulnerable population, increasing access, and promoting comprehensive care, support and treatment services. The objectives of NACP-IV are to reduce new infections and provide comprehensive care and support to all PLHIV and treatment services for all those who require it. The five cross-cutting themes that are being focused under NACP-IV are quality, innovation, integration, leveraging partnerships, and stigma and discrimination.

6. Social Action Social action is an organized effort to solve mass social problems. It always involves public pressure in one form or the other. It is a legally permitted activity to mobilize public opinion and public pressure to bring about socially acceptable changes or modification in social and economic institution. HIV transmitted mostly through behavior patterns that are intimate, the health authorities often find it difficult to make their services reach such high risk behavior groups. This gap can be bridged, if there are effective working relations between government and NGOs through their professionally trained workers. With the unchecked and the steady growth of HIV infection among people from every walk of life, counseling

153

 HIV/AIDS Discrimination, Stigmatization, and Denial

and guidance in HIV has become an essential aspect in dealing with the problems of AIDS. Papri Sri Raman (December 2011) in his article ‘How One Newspaper Thinks Positive’ presented an innovative approach of mass movement by social action in Chennai. On the Karur-Tiruchirapally lap, the trains are crammed every day with people coming to work in the big cities for Maragatham, 35 year old, a daily passenger on the train to Chennai, liked the eight page color newspaper, Positive +. She says that it is interesting because it is for the first time that she is able to read openly about HIV/AIDS in her own language. Positive + offers no competition to the 20 odd English and Tamil newspapers published from Chennai. In the very first issue, filmmaker and activist Ajit Hari, the Managing Editor of Positive + put it this way, “Everyone – simply everyone- who is infected has just one refrain, If only I knew.” Asma Naseer, the person behind the great idea, take the plunge? “Well” she says, “We had been thinking about doing it for several years, but never really put our minds to it. Now it has at last happened.” Anjali Singh (2011) in her article ‘Positive Theatre to Inspire Positive People’ gave importance the role of theatre for making aware in general people. The impact of such positive initiatives is important especially in a state like Uttar Pradesh. Because 80 per cent of the population live in rural areas and literacy levels are low. Information and communication technologies (ICTs) are broadly defined as technologies use to convey, manipulate and store data by electronic means. These means of ICTs play a vital role in not only making aware people in general but also presents new researches for Doctors in medical sciences surpassing the limit and time. At present when the internet produces Social networks that provide opportunities for professionals and employers to advertise and communicate. Social workers need to understand the capabilities of these networks and how they can be effectively understood, managed, and utilized. Our Prime Minister Mr. Narendra DamodarDas Modi also supports and utilizes the electronic means of resources.‘Mann ki Baat’ with the citizens of India on Radio once again proved the importance of ICTs in the country that mobilizes the people from grass root level. Dr. Ankuran Dutta and Dr. Anamika Ray (October 2013) in their article ‘Educational Television in India’ showed that television has become the most vibrant and effective mass communication tool globally. Dr. Ankuran Dutta and Dr. Anamika Ray (December 2013) again in their paper Educational Radio in India studied the impact of the role of radio in bringing about change in life through social action. Esther Kar (April 2013) described radio and its utilization for mass movement by saying that “Community Radio is by definition a broadcasting system established by the efforts of a specific or identified community, owned and operated by the community for the community’s welfare……in India community radio as a legally recognizable entity is a fairly recent phenomenon although using the national radio for social mobilization began as early as Independence. The emphasis on using radio broadcast technologies for rural development continued with independence and beyond. News letter of NACO under the Ministry of Health and Family Welfare, Government of India (2009) published a social campaign with the theme Service Delivery of STI Gets a Shot in the Arm. ‘International AIDS Candlelight Memorial draws Large Crowds in Nagaland and Haryana’ the Butterfly Nature Club of India (BNCI), a Panchkula based NGO, on behalf of the Global Health Council, held the Candlelight Memorial which is the world’s oldest and largest grassroots mobilization campaign for HIV/AIDS awareness and is led by community organizations in more than 100 countries together to honour the memories of those who have been claimed by AIDS. The theme for 2009 was “Together we are the solution”- a silent but powerful message to communities to become more compassionate and a6ccepting and to end stigma for times to come. United Nations Framework on HIV/AIDS and Human Rights provides international guidelines about HIV/AIDS and Human Rights. They provide a means for supporting both human rights and public health, 154

 HIV/AIDS Discrimination, Stigmatization, and Denial

emphasizing the synergy between these two areas. The framework set out key human rights principles which are relevant to HIV/AIDS and People Living with HIV/AIDS• • • • • • • • • • • • • • •

The right to the highest attainable standard of physical and mental health; The right to liberty and security of person; The right to freedom of movement; The right to seek and enjoy asylum; The right to privacy; The right to freedom of opinion and expression and the right to freely receive and impart information; The right to freedom of association; The right to work; The right to marry and to found a family; The right to equal access to education; The right to an adequate standard of living; The right to social security, assistance and welfare; The right to share in scientific advancement and its benefits; The right to participate in public and cultural life; The right to be free from torture and cruel, inhumane or degrading treatment or punishment.

Sexual health is a state of physical, emotional, mental and social wellbeing in relation to sexuality; it is not merely the absence of disease, dysfunction or infirmity sexual rights embrace Human Rights that are already recognized in National Laws International Human Rights, documents and other consensus statements. They include the right of all persons, free of coercion, discrimination and violence to the highest attainable standard of sexual health and to access to sexual and reproductive health care services (Surendran V. and Dr. Thasian.T. December 2011) The framework through mass social action urges all organizations and individuals working in the area of HIV/AIDS to adopt and promote the principles and human rights outlined in the framework. Hon’ble Union Health & Family Welfare Minister, Mr. J.P Nadda, inaugurated HIV/AIDS National Helpline. On World AIDS Day, December 1, 2014, National AIDS Control Organisation (NACO) launched the National Toll Free AIDS Helpline ‘1097’ number to answer queries related to HIV/AIDS from anywhere, anytime(NACO 2015).

Key Features of the Helpline 1. Call centre will be operational 24X7, & 365 days. 2. Well trained & experienced counsellors will respond to all calls. 3. Toll free 4-digit number ‘1097’ will be accessible from any landline/mobile phone of all major operators. 4. Anonymity & confidentiality will be maintained throughout the process. 5. Counsellors will answer calls in Hindi, Telugu, Kannada, Marathi, Tamil, Assamese, Bengali & English. As per call load it will be expanded. 6. On request, the information will be sent through SMS to the callers’ mobile numbers.

155

 HIV/AIDS Discrimination, Stigmatization, and Denial

CONCLUSION Since HIV cannot be transmitted through casual contact, normal learning activities within schools do not pose any threat of HIV infection. According to the American Academy of Paediatrics, there are no reported cases of HIV transmission occurring in the school setting, nor any epidemiological date, which justify the exclusion of children with HIV from school, or their isolation within school (Pediatrics 1999). It is a matter of grief that there is currently no statutory law affording protection to people living with HIV/AIDS against discrimination on the basis of their positive status in our country.

Key Messages About Normalisation and Disclosure • • • • • • •

People living with HIV/AIDS can live normal lives. Behave in polite manner with those with HIV/AIDS as friends, respect them as adults or children; they have the same feelings as you; as they are from our society. When HIV becomes AIDS, people likely get sick, in such circumstances not be as strong. In school, communicate with students about the advantages of voluntary counselling and testing, and diagnosis. Share the feeling of those infected and affected when a test comes back HIV positive. It is very difficult to talk on the matter of HIV and AIDS, but people talk about it, the more it will be accepted in the community and in society. When come to know about the HIV positive status of a person, behave normally and give him all the support that can.

Collaborative efforts of the Government and Non-Government Organization should be made; professional social workers, counsellor, pshychotherapist and other professional organization in coordination with NACO and SACS generate HIV awareness through seminars/conferences and workshops on the practices (both legal and programmatic) in different industries across the globe is important (Jyoti Kakkar, 2011). The Social Work Education plays a pivotal role in the lifes of HIV Positives and AIDS Patients thus contribute to Global Peace. Anupam Hazra (2011) rightly remarked, “Social Work is not just about doing good deeds and helping the under-privileged. Over a period of time, it has evolved into a profession. Correctly it is not a ‘conventional’ career. But with issues of disability, drug misuse, poverty, mental ill health, problems associated with aging etc. rising constantly, social work has become a vital need of our society today.” Kailash Satyarthi (2014) opines that the overall decline in morality and ethics in politics, business and social life is largely responsible for perpetual abuses and exploitation of children. We make big promises to improve the lives of children and shamelessly break them. We talk high but act low. Hypocrisy towards children is the biggest sin, for him. Studies in this field suggest an important association between social support, social inclusion and social cohesion on the one hand and positive health outcomes on the other side. It is the great challenge to ensure speedy and effective implementation of the intervention measures through cooperation and involvement of families and other care providers in the society. For upholding the standards and values of social work ethics, it is necessary that social workers are competent and literate in Information, Communication and Technologies. Professional Social workers can play their part by informing themselves about the impacts which HIV/AIDS is having on the individuals and community within which they are working and by developing appropriate strategies. Red Ribbon Express, for instance, was well equipped with all the tools and techniques of social work. 156

 HIV/AIDS Discrimination, Stigmatization, and Denial

The author worked as volunteer in RRE on 25 and 26 November 2012 at Agra Cantt. Railway Station, Uttar Pradesh India. All the instruments/ methods of social work were used in each of the compartment of RRE(train). The innovative approach were used to aware the people. The effective utilization of ICTs could be seen that helps in creating purposeful communication over there. It was a tremendous use of social work method under a roof. In every compartment there were trained volunteers/counsellors who entertained the visitors by providing solution/material to their querries. Overall it can be said that Red Ribbon Express is a specimen unit of Professional Social Work Practice. In combating with HIV/AIDS, the role of professional social workers become more genuine if they lobby for a coordinated response with other sectors such as health, education and business. To combat with HIV/AIDS is not a Child-Play, the Government, Non-Governmental Organization; People should come in the forefront to fight against this pandemic. There is much need of planning to come over it. Planning is defined as an array of services provided to families affected by HIV/AIDS who lack the financial resources to afford lawyers, psychiatrists, counselors, and other professionals needed to adequately plan for their children’s future. The goal of permanency planning is to assist parents in making legal arrangements for the future care of their children in the event of the parents’ incapacity or death. Permanency planning programs empower parents with the ability to effectively govern their families by providing the requisite resources for healthy child development. The principles of permanency planning are to maintain, wherever appropriate, continuity of family, to retain parental involvement, and to create stability during the transition from biological family to new caregiver. Therefore, the goal is to assist parents in legalizing custodial care for their children. The success of permanency planning depends upon its ability to address the complex needs of HIV [affected] families and the social challenges they encounter Federation of Protestant Welfare Agencies. (1999). The present picture is about a nightmare which is gradually turning into a reality and any discrepancy from our side may result in havoc. Hence, as a member of society called human beings whether we are HIV Positive or HIV Negative, have an essential duty to fight with this monster. This monster can be defeated only when our attack on this monster is from two sides, first through medical way and second through social work intervention.

REFERENCES Afsar, S.M. (2006). Work Place Blue. Combat Law, 5(2). American Psychological Association. (n.d.). Retrieved from: http://www.antrocom.net/upload/sub/ antrocom/060110/10-Antrocom.pdf Annual Report. (2011-12). Current Epidemiological Situation of HIV/AIDS. National AIDS Control Organization (NACO) Department of AIDS Control, Ministry of Health and Family Welfare, Government of India. Retrieved from: www.naco.gov.in Annual Report. (2013-14), Current Epidemiological Situation of HIV/AIDS. National AIDS Control Organization (NACO). India’s voice against AIDS. Department of AIDS Control, Ministry of Health and Family Welfare, Government of India. Retrieved from: www.naco.gov.in Banerjee, P., & Mattle, C. (2005). Knowledge, Perceptions and Attitudes of Youth in India regarding HIV/ AIDS: A Review of current literature’. International Electronic Journal of Health Education, 8, 48–56.

157

 HIV/AIDS Discrimination, Stigmatization, and Denial

Bharat, S., Aggleton, P. & Tyrer, P. (2001) India: HIV and AIDS-related Discrimination, Stigmatisation and Denial. UNAIDS. Bishnoi, A. (2011). Facing Up to HIV in Shangri-la. Social Welfare, 58(9). Centers for Disease Control and Prevention. (2002, September 27). Trends in sexual risk behaviors among high school students- United States, 1991-2001. Rockville, MD: U.S. Department of Health and Human Services. Chopra, R. (2012). Career With United Nations Organization (UNO). Employment News Weekly, 37(23). Choudhary, K. C. (2012). HIV/AIDS Prevention among Young People: A Psycho-Social Overview. Social Welfare, 59(9), 27–29. Deshmukh, D. (2012). Social Welfare in India. Social Welfare, 59(5). Dutta, A. & Ray, A. (2013). Educational Radio in India. Employment News Weekly, 38(36). Dutta, A. & Ray, A. (2013). Educational Television in India. Employment News Weekly, 38(27). Federation of Protestant Welfare Agencies. (1999). Permanency Planning in the Age of Advanced Treatment for HIV/AIDS. New York: Is the Crisis Over. Habib, Z. T., & Rahman, M. S. (2010). Psycho-scial Aspects of AIDS as a chronic Illness: Social Worker Role Perspective. Antrocom, 6(1), 80–89. Hazra, A. (2011). Current Prospects of Social Work in India. Employment News Weekly, 36(2). Herek, G. M. (1990). Illness, Stigma and AIDS. In P. T. Costa & G. R. Vanden Bos (Eds.), Psychological Aspects of serious illness: Chronic Conditions, fatal Diseases, and Clinical Care. ICMR Bulletin. (1990) Hospital Policies on care of HIV infected persons and prevention of accidental infection. Division of Publication and Information. ICMR, 20(4). ICMR Bulletin. (1991). HIV Infection- Current Status and Future Research Plans. Division of Publication and Information. ICMR, 21(12). International Association of Schools of Social Work. (2001). International Definition of Social Work. Retrieved from: http://www.iassw.soton.ac.uk/Generic/DefinitionOfSocialWork.asp?lang =en. Jones, T. T. (1996). AIDS thrives on racism. The Politics of AIDS. London: Bowerdean. Kakkar, J. (2011). Implications of HIV and AIDS amongst in organised sector workers in India. Contemporary Social Work, 3(1). Kar, E. (2013). Community Radio in India. Employment News Weekly, 39(1). Lager, P., Hamann, B., & Ashmore, M. (2008). Orientation for Social Work Practicum. Roles and Expectations in Social Work Practicum. IGNOU, MSW-005(2), 5. Launch of National Toll Free AIDS Helpline. (2015). Ministry of Health and Family Welfare. Government of India. Retrieved from: www.naco. gov.in

158

 HIV/AIDS Discrimination, Stigmatization, and Denial

Mathews, E. (2005). These Girls Are Game to Talk About Sexual Health. Social Welfare, 62(1). National Association of Social Workers. (2005). NASW and ASWB standards for technology and social work practice. Washington, DC: NASW Press. News, Service Delivery of STI Gets a shot in the Arm. (2009). A News Letter of the National AIDS Control Organisation. Ministry of Health and Family Welfare, Government of India. Retrieved from: www.naco.gov.in Nyirenda, J., & Schenker, I. (2002). HIV and AIDS Education in Schools. Positive Women Inc. Perron, B. E., Taylor, H. O., Glass, J. E., & Margerum-Leys, J. (2010). Information and Communication Technologies in Social Work. Advances in Social Work, 11(1). Retrieved from: http://journals.iupui.edu/ index.php/advancesinsocialwork/article/view/ Philipose, P. (2011). Imams Join the Fight against HIV/AIDS in Bangladesh. Social Welfare, 58(9). Rakesh, R. (2008). What a Positive Mother. Social Welfare, 55(8). Raman, P. S. (2011). How One Newspaper Thinks Positive. Social Welfare, 58(9). Rao, D., Angell, B., Lam, C., & Corrigan, P. (2008). Stigma in the workplace: Employer about people with HIV in Beijing, Hongkong and Chicago. Social Science & Medicine, 67(10). Reid, E. (1993). The HIV/AIDS pandemic is conceptually complex. It is both crisis and endemic condition, at once a specific issue and permeating-one. Sharing the Challenge of the HIV epidemic. HIV and United Nations Development Programme. Satyarthi, K. (2014).Towards A Child Friendly World. News Weekly, 39(34). Shernoff, M. (1998). Getting Started: Basic skills for effective social work with people with HIV and AIDS. In HIV and Social Work: A Practitioner’s Guide (pp. 27–49). New York: The Howarth Press. Singh, A. (2011). Positive Theatre to Inspire Positive People. Social Welfare, 58(9), 14. Singh, Z., & Banerjee, A. (2014). HIV/AIDS: Social and Ethical issues. MJAFI, 60(2). Retrieved from: http://medind.nic.in/maa/t04/i2/maat04i2p107.pdf Skinner, D., & Mfecane, S. (2004). Stigma, discrimination and the implications for people living with HIV/AIDS in South Africa. Journal of Social Aspects of HIV/AIDS, 1(3). Retrieved from: http://www. ncbi.nlm.nih.gov/pubmed/17601003\ Surendran, V., & Thasian, T. (2011). Human Rights Issues of People Living with HIV. Social Welfare, 58(9).

This research was previously published in Promoting Global Peace and Civic Engagement through Education edited by Kshama Pandey and Pratibha Upadhyay, pages 390-408, copyright year 2016 by Information Science Reference (an imprint of IGI Global).

159

Section 3

Blood Disorders

161

Chapter 9

An Artificial Intelligence Approach to Thrombophilia Risk João Vilhena Universidade de Évora, Portugal

Filomena Caldeira Hospital do Espírito Santo de Évora, Portugal

Henrique Vicente Universidade de Évora, Portugal

Rodrigo Gusmão Hospital do Espírito Santo de Évora, Portugal

M. Rosário Martins Universidade de Évora, Portugal

João Neves Drs. Nicolas & Asp, UAE

José Grañeda Hospital do Espírito Santo de Évora, Portugal

José Neves Universidade do Minho, Portugal

ABSTRACT Thrombophilia stands for a genetic or an acquired tendency to hypercoagulable states, frequently as venous thrombosis. Venous thromboembolism, represented mainly by deep venous thrombosis and pulmonary embolism, is often a chronic illness, associated with high morbidity and mortality. Therefore, it is crucial to identify the cause of the disease, the most appropriate treatment, the length of treatment or prevent a thrombotic recurrence. This work will focus on the development of a diagnosis decision support system in terms of a formal agenda built on a Logic Programming approach to knowledge representation and reasoning, complemented with a computational framework based on Artificial Neural Networks. The proposed model has been quite accurate in the assessment of thrombophilia predisposition (accuracy close to 95%). Furthermore, the model classified properly the patients that really presented the pathology, as well as classifying the disease absence (sensitivity and specificity higher than 95%).

DOI: 10.4018/978-1-5225-7122-3.ch009

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 An Artificial Intelligence Approach to Thrombophilia Risk

INTRODUCTION Thrombophilia is a genetic or acquired tendency to hypercoagulable states that increase the risk of arterial and often, venous thrombosis. Venous ThromboEmbolism (VTE) is represented by two main clinical events: Deep Venous Thrombosis (DVT) and Pulmonary Embolism (PE) which often constitute a unique clinical picture in which PE follows DVT (Previtaly, Bucciarelli, Passamonti, & Martinelli, 2011). VTE is a multifactorial disease, often asymptomatic and associated with high morbidity and mortality (East & Wakefield, 2010). The two most common factors for inherited (genetic) thrombophilias are the V Leiden mutation and the prothrombin G20210A gene mutation. Other mutations or polymorphisms associated with increased risk of thrombosis are methylenetetra-hydrofolate reductase 677C (Lim & Moll, 2015). People can have one abnormal gene (heterozygous state) or two abnormal genes (homozygous state). Less common genetic thrombophilia include deficiencies of the blood clotting proteins called protein C, protein S, and antithrombin (Lim & Moll, 2015; Previtaly et al., 2011). Secondary hypercoagulable states are a frequently acquired VTE in patients with underlying systemic diseases or clinical conditions, known to be associated with an increased risk of thrombosis (e.g., malignancy, pregnancy, and use of oral contraceptives, myeloproliferative disorders, hyperlipidemia, diabetes mellitus and abnormalities of blood vessels). The most common acquired thrombophilia is antiphospholipid antibody syndrome (Previtaly et al., 2011). The incidence of VTE is estimated at 56-160/100.000 people/year (East & Wakefield, 2010) and is strongly age-dependent, rising nearly 1% per year in old age (Rosendaal, 2005). Studies show that about 70% of patients presenting the first episode of VTE are over 60 years old, and the rate of recurrence is higher when the first episode of VTE occurs before 60 years old (Pernod et al., 2009). Moreover, a nonO blood group is associated with an increased risk of proximal deep vein thrombosis of the lower limbs with or without pulmonary embolism. The addition of inherited thrombophilia increases the thrombotic risk conferred by non-O group alone by almost 3-fold (Spiezia et al., 2013). Environmental or acquired VTE risk factors also include previous immobility, surgery, obesity, smoking habits and pregnancy or postpartum status (Anderson & Spencer, 2003; Enga et al., 2012; Goldhaber, 2010). Furthermore, the long distance travel is often associated with an up to 4-fold increased risk of VTE compared to nontravelers (Bartholomew, Schaffer, & McCormick, 2011) Follow-up of patients for prolonged periods after an initial DVT or PE has revealed that VTE often is a chronic illness requiring lifelong prevention strategies. Thus, it is crucial to identify the cause, the most appropriate treatment, how long the treatment should be or how to prevent a thrombotic recurrence (Sinescu, Hostiuc, & Bartos, 2011). In the case of patients with a high risk of clinical complications preventive actions should be taken. The screening for VTE is mandatory in three high-risk groups, namely women who are prescribed oral estrogen preparations, pregnancy morbidity and patients undergoing major orthopedic surgery (Wu et al., 2006). Thus, more studies are necessary to reach a correct identification of factors associated with these diseases in order to assess the individual risk of thrombosis, and promote more targeted prophylactic and therapeutic alternatives. On the one hand, in this study the complex pathophysiologic features of these hypercoagulable states (i.e., genetic, environmental and acquired risk factors) are discussed, being the problem tackled with Artificial Intelligence (AI) based methodologies and techniques for problem-solving (Chandrasekaran, 1983). Indeed, this work will focus on the development of an AI grounded Decision Support System aiming at the early diagnosis of thrombophilia, and also to signalizing of patients with hypercoagulable 162

 An Artificial Intelligence Approach to Thrombophilia Risk

states. On the other hand, this work reports the founding of a computational framework that is centred on a Logic Programming (LP) based approach to knowledge representation and reasoning (Neves, 1984; Neves, Machado, Analide, Abelha, & Brito, 2007), complemented with a computational framework based on Artificial Neural Networks (ANNs) (Cortez, Rocha, & Neves, 2004). One of its main features relies on the unvarying way the incomplete information is fingered, i.e., how it is treated, either quantitative or qualitative, as it will be shown below.

BACKGROUND Knowledge Representation and Reasoning Logic Programming (LP) has been used for knowledge representation and reasoning, representing a point of convergence in the disciplines of Logic, Mechanical Theorem Proving, and Computer Science. It may be given in terms of elements of Model Theory (Gelfon & Lifschitz, 1988; Kakas, Kowalski, & Toni, 1998; Pereira & Anh, 2009), or Proof Theory (Neves, 1984; Neves et al., 2007). In the present work, the Proof-Theoretical approach is followed as an extension to LP. Indeed, an Extended Logic Program is a finite set of clauses in the form: { ¬p ← not p,notexception  that stand  for predicate’sclous  ure ) p( p ← p1,, pn , not q1, , not qm ? (p1,, pn , not q1, , not qm ) (n,m ≥ 0) exception p 1

… exception p (0 ≤ j ≤ k ),being k and  integer number j

} ：：scoringvalue where “?” is a domain atom denoting falsity, the pi, qj, and p are classical ground literals, i.e., either positive atoms or atoms preceded by the classical negation sign ¬ (Neves, 1984). Indeed, ¬ stands for a strong declaration that speaks for itself, and not denotes negation-by- failure, or in other words, a flop in proving a given statement, once it was not declared explicitly. Under this formalism, every program

163

 An Artificial Intelligence Approach to Thrombophilia Risk

is associated with a set of abducibles (Kakas et al., 1998; Pereira & Anh, 2009), given here in the form of exceptions to the extensions of the predicates that make the program, i.e., clauses of the form: exception p exception p (0 ≤ j ≤ k ),being k and  integer number 1

j

that stand for information or knowledge that cannot be ruled out. On the other hand, clauses of the type: ? (p1,, pn , not q1, , not qm ) (n,m ≥ 0)

also named invariants or restrictions to comply with the universe of discourse, set the context under which it may be understood. The term scoringvalue stands for the relative weight of the extension of a specific predicate on the extensions of peers that make the inclusive or global program. Therefore, the Quality-of-Information (QoI) of a logic program will be given by a truth-value ranging between 0 and 1 (Lucas, 2004; Machado, Abelha, Novais, Neves, & Neves, 2008), i.e.: • •

QoIi = 1 when the extensions of the predicates that make the program are known (positive) or false (negative), and QoIi = 0 if such extensions are unknown; and For situations where the extensions of the predicates that make the program also include abducible sets, its terms (or clauses) present a QoIi ϵ ]0, 1[., i.e.:

QoI i = 1 Card

if the abducible set for predicatei is disjoint (where Card stands for set cardinality). A pictorial view of this process is given in Figure 1, as a pie chart. Card , If the abducible set is not disjoint, the cardinality K of the clause’s set is given by C 1Card +  + CCard under which the QoIs established in the form: Figure 1. QoI’s values for the abducible set for predicatei, when such a set is disjoint

164

 An Artificial Intelligence Approach to Thrombophilia Risk

QoI i

1≤i ≤Card



= 1 Card , ,  1 Card C1 C Card

Card where CCard is a card-combination subset, with Card elements. A pictorial view of this process is given in Figure 2, as a pie chart. However, a term’s QoI also depends on their attribute’s QoI. In order to evaluate this metric let us look at the Figure 3, where the segment with limits 0 and 1 stands for every attribute domain, i.e., all the attributes range in the interval [0, 1]. [A, B] denotes the scope where the unknown attributes values for a given predicate may occur, i.e., one may have:

QoI attributei  = 1 − A − B

where ||A–B|| stands for the modulus of the arithmetic difference between A and B. Therefore, one may have (Figure 4):

Figure 2. QoI’s values for the abducible set for predicatei, when such a set is not disjoint

Figure 3. Setting the QoIs of each attribute’s clause

165

 An Artificial Intelligence Approach to Thrombophilia Risk

Figure 4. QoI’s values for the abducible set for predicatei

When the abducible set is not disjoint

n

∑ (QoI

i

× pi ) / n denotes the QoI’s average of the attributes

i =1

of each clause (or term) that sets the extension of the predicate under analysis. n and pi stand for, respectively, for the attribute’s cardinality and the relative weight of attribute pi with respect to its peers  n   p = 1 .  ∑ i   i =1

Under this setting, a new metric has to be considered, which will be denoted as DoC, that stands for one’s confidence that the argument values or attributes of the terms that make the extension of a given predicate, having into consideration their domains, are in a given interval (Fernandes et al., 2015). The DoC is figured using DoC = 1 − ∆l 2 , where ∆l stands for the argument interval length, which was set to the interval [0, 1] (Figure 5). Thus, the universe of discourse is engendered according to the information presented in the extensions of such predicates, according to productions of the type: predicatei −

∪

1≤ j ≤m

((

) (

clause j QoI x , DoC x , , QoI x , DoC x 1

1

l

l

)) ：：QoI

j

：：DoC j

where ⋃, m and l stand, respectively, for set union, the cardinality of the extension of predicatei and number of attributes of each clause (Fernandes et al., 2015). The subscripts of QoIs and DoCs, x1,…, xl, stand for the attributes values ranges. As an example, let us consider the logic program given by:

166

 An Artificial Intelligence Approach to Thrombophilia Risk

Figure 5. Evaluation of the Degree of Confidence

{

((

) (

) (

¬f1  QoI x , DoC x ,QoI x , DoC x ,QoI x , DoC x 1

((

1

2

) (

2

3

) (

3

))

← not  QoI x , DoC x ,QoI x , DoC x ,QoI x , DoC x 1

1

((

2

2

3

3

))

)

)

f1 QoI 5, 7 , DoC 5, 7 ,(QoI ⊥ , DoC ⊥ ),(QoI 6.5 , DoC 6.5 ), ：：QoI ：：DoC       attribute ' s values

5,10 12, 36  0, 8        



attribute`s domains

exception f

1

((QoI , DoC ),(QoI 4

4

 30, 35  

)

)

, DoC 30, 35 ,(QoI ⊥ , DoC ⊥ ) :: QoI :: DoC 



… exception f

k

((QoI , DoC ),(QoI ⊥

⊥

10

(

, DoC 10 ), QoI 7, 8 , DoC 7,8 







)) :: QoI :: DoC

} :: 1 (once the universe of discourse is set in terms of the extension of only one predicate)

167

 An Artificial Intelligence Approach to Thrombophilia Risk

where ⊥ denotes a value of the type unknown and f1,1 … f1,k stand for the abducible or exception set for predicate f1.

Artificial Neural Networks ANNs are computational tools which attempt to simulate the architecture and internal operational features of the human brain and nervous system. The Multilayer Perceptron (MLP) is one of the most popular ANN architectures, where neurons are grouped in layers and only onward connections exist (Haykin, 2009). That provides a powerful base-learner, with advantages such as nonlinear mapping and noise tolerance, increasingly used in Data Mining due to its good behavior regarding predictive knowledge (Mitra, Pal, & Mitra, 2002). The interest in MLPs was stimulated by the introduction of the Backpropagation algorithm in 1986 (Rumelhart, Hinton, & Williams, 1986), and since then several fast gradient based variants have been proposed (e.g., RPROP) (Riedmiller, 1994). These training algorithms minimize an error function by tuning the modifiable parameters of a fixed architecture, which need to be set a priori. The MLP performance will be sensitive to this choice, i.e., a small network will provide limited learning capabilities, while a large one will induce generalization loss (i.e., overfitting). The correct design of the MLP topology is a complex and crucial task, commonly addressed by trial-and-error procedures (e.g., exploring a different number of hidden nodes), in a blind search strategy, which only goes through a small set of possible configurations. More elaborate methods have also been proposed, such as pruning (Thimm & Fiesler, 1995) and constructive (Kwok & Yeung, 1997) algorithms, although these perform hill-climbing and are thus prone to local minima (Cortez et al., 2004). On the other hand, the number of nodes in the input layer set the number of independent variables, while those in the output layer denote one and all the dependent ones (Haykin, 2009). In the most recent years, several decision support systems have been applied to various problems in the medical field. Indeed, in the diagnosis process, the physicians are faced with the significant amount of information ranging from details of clinical symptoms to various types of biochemical data and outputs of imaging devices. In order to streamline the diagnostic process and avoid misdiagnosis, several decision support systems have been developed based on AI methodologies, like ANNs. Esfandiari, Babavalian, Moghadam, & Tabar (2014) reviewed 291 papers, published between 1999 and 2013 that address the problem of extracting knowledge from medical databases. These authors considered six medical tasks (screening, diagnosis, treatment, prognosis, monitoring, and management), and four data mining goals (classification, regression, clustering and association). Data mining algorithms included Decision Trees, ANNs, and k-means Clustering Methods, among others. Amato et al. (2013) review and discuss the capabilities and limitations of ANNs in medical diagnosis that include several pathologies such as cardiovascular diseases, cancer, and diabetes. Martins et al. (2015) developed a decision support system using ANNs to evaluate the acute coronary syndrome predisposing with an overall accuracy higher than 95%. Neves et al. (2015) presented a computer-aided diagnostics system, based on ANNs, aiming an early detection of breast cancer. This risk assessment model includes genetic risk factors and hormonal factors. The sample comprised 217 patients (breast cancer was diagnosed in forty-one cases). The model classifies properly the patients that actually presented the pathology (sensitivity higher than 96.6%), as well as the absence of the illness (specificity close to 95%).

168

 An Artificial Intelligence Approach to Thrombophilia Risk

MATERIALS AND METHODS Source of Data Data used to develop a predictive model to assess the Thombophilia Predisposition Risk were taken from the health records of patients followed up in the Laboratory of Clinical Pathology of the Hospital do Espírito Santo de Évora (HESE), Portugal. The study protocol was approved by the Ethics Committee of HESE. Demographic data, clinical history, complementary diagnostic tests and the final diagnosis were obtained by accessing the HESE information system.

Participants This study included 349 patients, aged between 18 to 85 years old, with an average of 46 ± 16 years old. The gender distribution was 34.2% and 65.8% for male and female, respectively. In 141 patients, i.e., 40.4% of the cohort, it was observed thrombophilia, i.e., it is a state in which there is a predisposition of venous thrombosis, confirmed by the clinical history of the patient, which includes one or more thrombotic processes. The patients included in this subset aged between 22 to 85 years old (average of 50 ± 17 years old), and the gender distribution was 37.3% for male and 62.7% female.

Extract, Transform, and Load Process In order to develop a predictive model to assess the VTE predisposing it was necessary to gather data from several sources and carry out an Extract, Transform, and Load process to organize the information. The information was held in a star schema, which consists of a collection of tables that are logically related to each other (O’Neil, O’Neil, & Chen, 2009). To obtain a star schema, it was essential to follow a few steps. In the former one it was necessary to understand the problem in study and gather the parameters that have influence on the final outcome, i.e., we are going to consider some variables that may affect the thrombophilia predisposing, which may be grouped in six categories (i.e., Age/Heredity and Blood Group Predisposition (Sacher, 1999; Spiezia et al., 2013), Life Style Risk Factors (Bartholomew et al., 2011; Enga et al., 2012), Natural Anticoagulants (Lim & Moll, 2015; Previtaly et al., 2011), Thrombotic Risk Factors (Anderson & Spencer, 2003), Earlier Secondary Factors (Rosendaal, 2005; Goldhaber, 2010) and Mutations/Polymorphisms (Lim & Moll, 2015 Previtaly et al., 2011)). The second step was related to the dimensions that would be needed to define these parameters on the facts table. Finally, information from several sources was collected (Figure 6), transformed according to the dimension tables and loaded to the fact table. The star schema conceived for this study (Figure 7) takes into account the variables that characterize the thrombophilia predisposing (Facts Table) where Dim Tables show how data were classified. The Body Mass Index (BMI) contributes to a low, moderate, high or very high risk of VTE since it was lower than 25, between [25, 30[, between [30, 35[ or higher than 35, respectively (World Health Organization [WHO], 2015). Likewise, the Smoking Status contributes to a low, moderate, high or very high risk of thrombophilia since the patient was a never smoker, ex- smoker, moderate smoker or heavy smoker (> 20 pack-years) (Enga et al., 2012). The risk associated with the Air Travel range from low, moderate, high and very high for patients without previous story of thrombotic complications,

169

 An Artificial Intelligence Approach to Thrombophilia Risk

with previous thrombophilia in short flight duration (minus than 4 hours), multiple long-haul flights of at least 4 hours or long-haul flights of more than 8 to 10 hours respectively (Bartholomew et al., 2011). The model’s architecture for a single major healthcare facility is given in Figure 6. As it may be seen, the core of the system is built on a computational platform, here denoted as AIDA, which stands for an Agency for the Integration, Diffusion, and Archive of patient information. This kind of platform is located across all the key healthcare facilities, allowing for their interconnection.

Qualitative Data Pre-Processing Aiming at the quantification of the qualitative information and in order to make easy the understanding of the process, it was decided to put it in a graphical form. Taking as an example a set of 3 (three) issues regarding a particular subject (where the possible alternatives are none, low, moderate, high and very high), a unitary radius circle split into 3 (three) slices is itemized (Figure 8). The marks in the axis correspond to each of the possible choices. If the answer to issue 1 is high, the correspondent area is π × 0.752 3 , i.e., 0.19 π (Figure 8(a)). Assuming that in the issue 2 are chosen the alternatives high and very high, the correspondent area ranges in the interval π × 0.752 / 3, π × 12 / 3 , i.e., 0.19 π, 0.33π  (Fig



ure 8(b)). Finally, in issue 3 if no alternative is ticked, all the hypotheses should be considered and the area varies in the interval 0, π × 12 / 3 , i.e., 0,0.33π  (Figure 8(c)). The total area is the sum of the 



partial ones and is set in the interval 0.38 π, 0.85π  (Figure 8(d)). The normalized area is the ratio between the area of the figure and the area of the unitary radius circle. Thus, the quantitative value regarding the subject in analysis is set to the interval 0.38, 0.85 . Figure 6. The model’s architecture

170

 An Artificial Intelligence Approach to Thrombophilia Risk

Figure 7. An overview of the relational data model

Figure 8. A view of the qualitative evaluation process

171

 An Artificial Intelligence Approach to Thrombophilia Risk

It is now possible to build up a knowledge database given in terms of the extensions of the relations depicted in Figure 9, which stand for a situation where one has to manage information aiming to assess thrombophilia predisposition. Under this scenario some incomplete and/or unknown data is also available. For instance, in case 1, the methylenetetrahydrofolate reductase 677C/T mutation is unknown, which is depicted by the symbol ⊥, while the Age/Heredity Predisposing ranges in the interval [0.5, 5]. Applying the algorithm presented in (Fernandes et al., 2015) to the fields that make the knowledge base for thrombophilia predisposition assessment (Figure 9) and looking to the DoCs values obtained, it is possible to set the arguments of the predicate thrombophilia (thromb) referred to below, that also denotes the objective function with respect to the problem under analyze: thromb : Age / H eredity Predisposition , Blood Group Predisposition , N atural Anticoagulants Major ,Eaelier Secondary Factors ,M utations / Polymorphisms , Life Style Risk Factors ,T  hrombotic Risk Factors → {0, 1 }

where 0 (zero) and 1 (one) denote, respectively, the truth values false and true. The algorithm presented in (Fernandes et al., 2015) encompasses different phases. In the former one the clauses or terms that make the extension of the predicate under study are established. In the subsequent stage, the arguments of each clause are set at continuous intervals. In a third step, the boundaries of the attributes’ intervals are set in the interval [0, 1], according to a normalization process given by the expression (Y −Ymin ) (Ymax −Ymin ) , where the Ys stand for themselves. Finally, the DoC is evaluated as described above. Exemplifying the application of the algorithm presented in (Fernandes et al., 2015), to a term (case) that presents feature vector (Age/Heredity Predisposing = [0.5, 5], Blood Group Predisposing = [0.18, 0.3], Natural Anticoagulants Major = 1, Earlier Secondary Factors = [2, 3] Mutations/ /Polymorphisms = ⊥, Life Style Risk Factors = 0.19, Thrombotic Risk Factors = 1), one may have: Begin DoCs evaluation

{

((

) (

)

)

¬thromb   QoI A/H ,DoC A/H ,, QoI M /P ,DoC M /P , , (QoITR ,DoCTR )

((

) (

)

)

← not thromb   QoI A/H ,DoC A/H ,, QoI M /P ,DoC M /P , , (QoITR ,DoCTR )

((

)

)

thromb 10.5, 5 , DoC 0.5, 5 ,, (1⊥ , DoC ⊥ ), , (11,DoC 1 ) :: 1 :: DoC       attribute‘ s values

 0,10  0,5  0,1        attribute‘ s domains

172



 An Artificial Intelligence Approach to Thrombophilia Risk

Figure 9. A fragment of the knowledge base to assess thrombophilia predisposition risk. (a) (Sacher, 1999), (b) (Spiezia et al., 2013)

173

 An Artificial Intelligence Approach to Thrombophilia Risk

} :: 1

{

((

) (

)

)

¬thromb   QoI A/H ,DoC A/H ,, QoI M /P ,DoC M /P , , (QoITR ,DoCTR )

((

) (

)

)

← not thromb   QoI A/H ,DoC A/H ,, QoI M /P ,DoC M /P , , (QoITR ,DoCTR )

((

) (

))

) (

thromb  10.5,5 ,DoC 0.5,5 , , 10,1 ,DoC 0,1 , , 11,1 ,DoC 1,1 ７ 1 ７ DoC                attribute‘ s values ranges

 0,10  0,1  0,5        



attribute‘ s domains

}７ 1

{

((

) (

)

)

¬thromb   QoI A/H ,DoC A/H ,, QoI M /P ,DoC M /P , , (QoITR ,DoCTR )

((

) (

)

)

← not thromb   QoI A/H ,DoC A/H ,, QoI M /P ,DoC M /P , , (QoITR ,DoCTR )

((

) (

))

) (

thromb 10.1, 1 , DoC 0.1, 1 , , 10, 1 , DoC 0, 1 , , 10.1, 0.1 , DoC 0.1, 0.1 :: 1 :: DoC                 attrribute`s values ranges once normalized

 0,1  0,1  0,1         attribute‘ s domains once normalized 

} :: 1

{

((

) (

)

)

¬thromb   QoI A/H ,DoC A/H ,, QoI M /P ,DoC M /P , , (QoITR ,DoCTR )

((

) (

)

)

← not thromb   QoI A/H ,DoC A/H ,, QoI M /P ,DoC M /P , , (QoITR ,DoCTR )

174



 An Artificial Intelligence Approach to Thrombophilia Risk

(

)

thromb (1, 0.43), , (1, 0), , (1, 1) ::1::0.75  attribute`s quality −of −information and respective confidence values

 0.1, 0.1  0,1  0.1,1         



attribbute`s values ranges once normalized

} ::1

Model Validation and Performance Assessment On the one hand, in our model what serves as truth or the gold standard to assess the presence or absence of disease is the output of the ANN, in terms of the variables Thrombophilia_predisposition (taking values from the {0, 1}) and Confidence (that ranges in the interval [0,1]. On the other hand, to ensure statistical significance of the attained results, 30 (thirty) runs were applied in all tests. In each simulation, the available data is randomly divided into two mutually exclusive partitions, i.e., the training set, with about two-thirds of the available data and used to construct the models, and the test set, with the remaining cases being used after training, in order to validate the model. The performance assessment of model is carried out based on the coincidence matrix, i.e., a matrix of size L × L, where L denotes the number of possible outputs classes (two in the present case). This matrix is created by matching the predicted and target values. Based on coincidence matrix, it is possible to compute sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) of the classifier: sensitivity = TP (TP + FN ) specificity = TN (TN + FP ) PPV = TP (TP + FP ) NPV = TN (TN + FN )

where TP, FN, TN and FP stand, respectively, for True Positives, False Negatives, True Negatives and False Positives. The sensitivity and specificity are measures of the performance of a binary classifier. Sensitivity evaluates the proportion of true positives that are correctly identified as such, while specificity translates the proportion of true negatives that are correctly identified. Moreover, it is necessary to know the probability of the classifier that gives the correct response. Thus, both PPV and NPV are also calculated, while PPV stands for the proportion of cases with positive results which are correctly classified, NPV denotes the proportion of cases with negative results which are successfully labeled (Florkowski, 2008). In addition, the Receiver Operating Characteristic (ROC) curves were considered. A ROC curve displays the trade-off between sensitivity and specificity and may be used to visualize the performance

175

 An Artificial Intelligence Approach to Thrombophilia Risk

of a binary classifier, i.e., a model with two possible output classes in the present case. The Area Under the Curve (AUC) quantifies the overall ability of the test to discriminate between the output classes. The AUC can be interpreted as the probability that a randomly chosen positive case is rated or ranked as more likely to be positive than a randomly chosen negative case (Hajian-Tilaki, 2013). The maximum AUC, i.e., 1 (one) means that the test is perfect in the differentiation between the two possible output classes. That happens when the distribution of test results for the output classes does not overlap. The minimum AUC should be considered a chance level, i.e., AUC = 0.5, since AUC = 0 means that the test classifies all cases incorrectly.

RESULTS AND DISCUSSION Sample Characterization The inherited risk factors were observed in 141 patients with hypercoagulable states (i.e., 40.4% of the cohort). Gene mutations/polymorphisms and natural coagulation proteins were observed in 127 patients (90.1%) and 17 patients (12.1%), respectively. Results show that within natural coagulation (major), the protein S deficit was the predominant (7.8%). The most frequent mutations/polymorphisms were the heterozygous MTHFR 677C/T (45.5%) and PAI-I 5G/4G (52.1%). Furthermore, in 20.4% of populations, the MTHFR 677C/T and PAI-I 5G/4G mutations were observed simultaneously. Conversely, only seven patients presented three heterozygous mutations, namely MTHFR 677C/T, PAI-I 5G/4G and Prothrombin 20210.

Artificial Neural Network Based Approach to Computing The LP approach to data processing, previously presented, demonstrates how the information comes together to form a diagnosis. In this section, a data mining approach to deal with this information is considered. A hybrid computing approach to model the universe of discourse was set, based on ANNs, which are used to structure data and capture complex relationships between inputs and outputs (Vicente, Couto, Machado, Abelha, & Neves, 2012; Vicente et al., 2012; Vicente, Roseiro, Arteiro, Neves, & Caldeira, 2013). One of the main contributions of this work is related to the ability to deal with incomplete data/ information/knowledge. Besides to a classifier that enables the assessment of thrombophilia predisposition, the proposed approach also intends to obtain the DoC associated with this prediction. Thus, it is necessary to use a data mining algorithm that will enable to consider more than one output variable. The choice fell on ANNs due to their dynamics characteristics like adaptability, robustness and flexibility. ANNs simulate the structure of the human brain, being populated by multiple layers of neurons, with a valuable set of activation functions. As an example, let us consider the case given above, where one may have a situation in which the evaluation of VTE predisposition is needed. In Figure 10, it is shown how the normalized values of the interval boundaries and their DoC and QoI values work as inputs to the ANN. The output depicts the thrombotic risk, plus the confidence that one has on such a happening. The back propagation algorithm was used in the learning process of the ANN. As the output function, in the pre-processing layer, it was used the identity one. In the other layers was used the sigmoid function.

176

 An Artificial Intelligence Approach to Thrombophilia Risk

Figure 10. The Artificial Neural Network topology

Table 1 presents the coincidence matrix for ANN model (the values denote the average of the 30 experiments). A glance at Table 1 shows that the model accuracy was 96.6% for the training set (226 correctly classified in 234) and 94.8% for the test set (109 correctly classified in 115). Thus, the predictions made by the ANN model are satisfactory, attaining accuracies close to 95%. Based on coincidence matrix it is possible to compute Sensitivity, Specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) for the classifier. The corresponding Sensitivity, Specificity, PPV and NPV values are displayed in Table 2 for training and test sets. A perusal of Table 2 shows that the Sensitivity is similar for training and test sets, while the Specificity ranges from 94.2% to 97.1%. Moreover, PPV, in turns ranges from 91.7% to 95.8%, while NPV is similar for both sets. On the one hand, the proposed approach proved to be sufficiently sensitive to diagnose correctly patients with the hypercoagulable condition. On the contrary, it was highly specific, since false positives can have a negative impact on clinical decisions. The ROC curves for the training, and test sets are shown in Figure 11. The area under ROC curves is higher than 0.95 for both cases, denoting that the model exhibits a good performance in recognition of thrombophilia predisposing.

177

 An Artificial Intelligence Approach to Thrombophilia Risk

Table 1. The coincidence matrix for ANN model Predictive Training set

Target True (1)

Test set False (0)

True (1)

False (0)

True (1)

TP = 91

FN = 4

TP = 44

FN = 2

False (0)

FP = 4

TN = 135

FP = 4

TN = 65

Table 2. Sensitivity, specificity, Positive Predictive Value (PPV) and Negative Predictive Value (NPV) for the Artificial Neural Network model Sensitivity (%)

Specificity (%)

PPV (%)

NPV (%)

Training set

95.8

97.1

95.8

97.1

Test set

95.7

94.2

91.7

97.0

Figure 11. The ROC curves for training set (―) and for test set (− −)

CONCLUSION This work presents an intelligent decision support system to assess thrombophilia predisposition. It stands for a new approach to the problem of Thrombophilia Risk, which is centred on a formal framework based on LP for Knowledge Representation and Reasoning, is subject to formal proof, being complemented with an ANN approach to computing that caters for the handling of incomplete, unknown, or even self-

178

 An Artificial Intelligence Approach to Thrombophilia Risk

contradictory information. The extensions of the predicates that make the universe of discourse are given in terms of QoIs and DoCs that stand, respectively, for the arguments Quality-of-Information and one’s Degree-of-Confidence that the predicates argument values fit into a given interval considering their respective domains, being the data/information/knowledge under analyse either unknown, incomplete, or even self-contradictory (Neves et al., 2015; Neves, Silva, Neves, & Vicente, 2016). The presented approach presents a worthy performance in the diagnosis of thrombophilia, due to the sensitivity and specificity which exhibited values near 96%. These findings were corroborated by the area under ROC curves (> 0.95). This approach focuses on the processing of information acquired from molecular and biochemical parameters and clinical data in order to identify patients with hypercoagulable states, to prevent recurrent events, to monitor the treatment of patients with chronic illness and improve their Quality-of-Life. Indeed, the system has been well accepted by the physicians and, in the future; it is intended to fit it in mobile devices, increasing, therefore, its acceptability by the patients.

REFERENCES Amato, F., López, A., Peña-Méndez, E. M., Vaňhara, P., Hampl, A., & Havel, J. (2013). Artificial neural networks in medical diagnosis. Journal of Applied Biomedicine, 11(2), 47–58. doi:10.2478/v10136012-0031-x Anderson, F. A., & Spencer, F. A. (2003). Risk Factors for Venous Thromboembolism. Circulation, 107(90231), 9I-–16. doi:10.1161/01.CIR.0000078469.07362.E6 PMID:12814980 Bartholomew, J. R., Schaffer, F., & McCormick, G. F. (2011). Air travel and venous thromboembolism: Minimizing the risk. Cleveland Clinic Journal, 79(2), 111–120. doi:10.3949/ccjm.78a.10138 PMID:21285343 Chandrasekaran, B. (1983). On Evaluating Artificial Intelligence Systems for Medical Diagnosis. AI Magazine, 4, 34–48. Cortez, P., Rocha, M., & Neves, J. (2004). Evolving Time Series Forecasting ARMA Models. Journal of Heuristics, 10(4), 415–429. doi:10.1023/B:HEUR.0000034714.09838.1e East, A. T., & Wakefield, T. W. (2010). What is the optimal duration of treatment for DVT? An update on evidence-based medicine of treatment for DVT. Seminars in Vascular Surgery, 23(3), 182–191. doi:10.1053/j.semvascsurg.2010.05.006 PMID:20826296 Enga, K. F., Brækkan, S. K., Hansen-Krone, I. J., Le Cessie, S., Rosendaal, F. R., & Hansen, J. B. (2012). Cigarette smoking and the risk of venous thromboembolism: The Tromsø Study. Journal of Thrombosis and Haemostasis, 10(10), 2068–2074. doi:10.1111/j.1538-7836.2012.04880.x PMID:22882779 Esfandiari, N., Babavalian, M. R., Moghadam, A.-M., & Tabar, V. K. (2014). Knowledge discovery in medicine: Current issue and future trend. Expert Systems with Applications, 41(9), 4434–4463. doi:10.1016/j.eswa.2014.01.011 Fernandes, F., Vicente, H., Abelha, A., Machado, J., Novais, P., & Neves, J. (2015). Artificial Neural Networks in Diabetes Control. Proceedings of the 2015 Science and Information Conference - SAI 2015 (pp. 362–370). IEEE.

179

 An Artificial Intelligence Approach to Thrombophilia Risk

Florkowski, C. M. (2008). Sensitivity, Specificity, Receiver-Operating Characteristic (ROC) Curves and Likelihood Ratios: Communicating the Performance of Diagnostic Tests. The Clinical Biochemist. Reviews / Australian Association of Clinical Biochemists, 29(Suppl. 1), S83–S87. PMID:18852864 Gelfond, M., & Lifschitz, V. (1988). The stable model semantics for logic programming. In R. Kowalski, & K. Bowen (Eds.), Logic Programming – Proceedings of the Fifth International Conference and Symposium (pp. 1070-1080). Goldhaber, S. (2010). Risk factors for venous thromboembolism. Journal of the American College of Cardiology, 56(1), 1–7. doi:10.1016/j.jacc.2010.01.057 PMID:20620709 Hajian-Tilaki, K. (2013). Receiver Operating Characteristic (ROC) Curve Analysis for Medical Diagnostic Test Evaluation. Caspian Journal of Internal Medicine, 4, 627–635. PMID:24009950 Haykin, S. (2009). Neural Networks and Learning Machines (3rd ed.). New York: Prentice Hall. Kakas, A., Kowalski, R., & Toni, F. (1998). The role of abduction in logic programming. In D. Gabbay, C. Hogger, & I. Robinson (Eds.), Handbook of Logic in Artificial Intelligence and Logic Programming (Vol. 5, pp. 235–324). Oxford, United Kingdom: Oxford University Press. Kwok, T., & Yeung, D. (1997). Constructive algorithms for structure learning in feedforward neural networks for regression problems: A survey. IEEE Transactions on Neural Networks, 8(3), 630–645. doi:10.1109/72.572102 PMID:18255666 Lim, M. Y., & Moll, S. (2015). Thrombophilia. Vascular Medicine, 20(2), 193–196. doi:10.1177/1358863X15575769 PMID:25832606 Lucas, P. (2004). Quality checking of medical guidelines through logical abduction. In F. Coenen, A. Preece, & A. Mackintosh (Eds.), Research and Developments in Intelligent Systems XX (pp. 309–321). London, United Kingdom: Springer. doi:10.1007/978-0-85729-412-8_23 Machado, J., Abelha, A., Novais, P., Neves, J., & Neves, J. (2008). Quality of service in healthcare units. In C. Bertelle, & A. Ayesh, (Eds.), Proceedings of the ESM 2008 (pp. 291-298). Ghent, Belgium: Eurosis – ETI Publication. Martins, M. R., Mendes, T., Grañeda, J. M., Gusmão, R., Vicente, H., & Neves, J. (2015). Artificial Neural Networks in Acute Coronary Syndrome Screening. In F. Ortuño & I. Rojas (Eds.), Bioinformatics and Biomedical Engineering, LNCS (Vol. 9043, pp. 108–119). Cham, Switzerland: Springer International Publishing. doi:10.1007/978-3-319-16483-0_11 Mitra, S., Pal, S., & Mitra, P. (2002). Data mining in soft computing framework: A survey. IEEE Transactions on Neural Networks, 13(1), 3–14. doi:10.1109/72.977258 PMID:18244404 Neves, J. (1984). A logic interpreter to handle time and negation in logic databases. In R. L. Muller, & J. J. Pottmyer (Eds.), Proceedings of the Annual Conference of the ACM on the Fifth Generation Challenge (pp. 50-54). New York: Association for Computing Machinery.

180

 An Artificial Intelligence Approach to Thrombophilia Risk

Neves, J., Guimarães, T., Gomes, S., Vicente, H., Santos, M., Neves, J., ... Novais, P. (2015). Logic Programming and Artificial Neural Networks in Breast Cancer Detection. In I. Rojas, G. Joya, & A. Catala (Eds.), Advances in Computational Intelligence, LNCS (Vol. 9095, pp. 211–224). Cham, Switzerland: Springer International Publishing. doi:10.1007/978-3-319-19222-2_18 Neves, J., Machado, J., Analide, C., Abelha, A., & Brito, L. (2007, December 3-7). The halt condition in genetic programming. In J. Neves, M. F. Santos, & J. Machado (Eds.), Progress in Artificial Intelligence: 13th Portuguese Conference on Artificial Intelligence, EPIA 2007, Guimarães, Portugal, LNAI (Vol. 4874, pp. 160-169). Berlin, Germany: Springer. 10.1007/978-3-540-77002-2_14 Neves, J., Silva, E., Neves, J., & Vicente, H. (2016). Evaluation of Nosocomial Infection Risk Using a Hybrid Approach. In J. Machado & A. Abelha (Eds.), Applying Business Intelligence to Clinical and Healthcare Organizations (pp. 24–42). Hershey, PA, USA: IGI Global. doi:10.4018/978-1-4666-98826.ch002 O’Neil, P., O’Neil, B., & Chen, X. (2009). Star Schema Benchmark – Revision 3. Retrieved from http:// www.cs.umb.edu/~poneil/StarSchemaB.pdf Pereira, L. M., & Anh, H. T. (2009). Evolution prospection. In K. Nakamatsu (Ed.), New Advances in Intelligent Decision Technologies: Results of the First KES International Symposium IDT 2009 (Studies in Computational Intelligence) (Vol. 199, pp. 51-64). Berlin, Germany: Springer. 10.1007/978-3-64200909-9_6 Pernod, G., Biron-Andreani, C., Morange, P.-E., Boehlen, F., Constans, J., Couturaud, F., ... Wahl, D. (2009). Recommendations on testing for thrombophilia in venous thromboembolic disease: A French consensus guideline. Journal des Maladies Vasculaires, 34(3), 156–203. doi:10.1016/j.jmv.2009.02.005 PMID:19645086 Previtali, E., Bucciarelli, P., Passamonti, S. M., & Martinelli, I. (2011). Risk factors for venous and arterial thrombosis. Blood Transfusion, 9, 120–138. PMID:21084000 Riedmiller, M. (1994). Advanced supervised learning in multilayer perceptrons – From backpropagation to adaptive learning algorithms. Computer Standards & Interfaces, 16(3), 265–278. doi:10.1016/09205489(94)90017-5 Rosendaal, F. R. (2005). Venous Thrombosis: The Role of Genes, Environment, and Behavior. Hematology, 2005(1), 1–12. doi:10.1182/asheducation-2005.1.1 PMID:16304352 Rumelhart, D., Hinton, G., & Williams, R. (1986). Learning internal representation by error propagation. In D. Rumelhart & J. McClelland (Eds.), Parallel Distributed Processing: Explorations in the Microstructures of Cognition (Vol. 1, pp. 318–362). Cambridge: MIT Press. Sacher, A. R. (1999). Thrombophilia: A Genetic Predisposition to Thrombosis. Transactions of the American Clinical and Climatological Association, 110, 51–61. PMID:10344006 Sinescu, C., Hostiuc, M., & Bartos, D. (2011). Idiopathic venous thromboembolism and thrombophilia. Journal of Medicine and Life, 4, 57–62. PMID:21505575

181

 An Artificial Intelligence Approach to Thrombophilia Risk

Spiezia, L., Campello, E., Bom, M., Tison, T., Milan, M., Simioni, P., & Prandoni, P. (2013). ABO blood groups and the risk of venous thrombosis in patients with inherited thrombophilia. Blood Transfusion, 11, 250–253. PMID:23114529 Thimm, G., & Fiesler, E. (1995). Evaluating pruning methods. Proceedings of the International Symposium on Artificial Neural Networks (pp. 20-25). Vicente, H., Couto, C., Machado, J., Abelha, A., & Neves, J. (2012). Prediction of Water Quality Parameters in a Reservoir using Artificial Neural Networks. International Journal of Design & Nature and Ecodynamics, 7(3), 309–318. doi:10.2495/DNE-V7-N3-309-318 Vicente, H., Dias, S., Fernandes, A., Abelha, A., Machado, J., & Neves, J. (2012). Prediction of the Quality of Public Water Supply using Artificial Neural Networks. Journal of Water Supply: Research & Technology - Aqua, 61(7), 446–459. doi:10.2166/aqua.2012.014 Vicente, H., Roseiro, J., Arteiro, J., Neves, J., & Caldeira, A. T. (2013). Prediction of bioactive compound activity against wood contaminant fungi using artificial neural networks. Canadian Journal of Forest Research, 43(11), 985–992. doi:10.1139/cjfr-2013-0142 World Health Organization. (2015). Obesity and overweight. Fact Sheet Number 311. Retrieved from http://www.who.int/mediacentre/factsheets/fs311/en/ Wu, O., Robertson, L., Twaddle, S., Lowe, G. D., Clark, P., Greaves, M., ... Greer, I. (2006). Screening for thrombophilia in high-risk situations: systematic review and cost-effectiveness analysis. The Thrombosis: Risk and Economic Assessment of Thrombophilia Screening (TREATS) study. Health Technology Assessment, 10(11). doi:10.3310/hta10110 PMID:16595080

This research was previously published in the International Journal of Reliable and Quality E-Healthcare (IJRQEH), 6(2); edited by Anastasius Moumtzoglou, pages 49-69, copyright year 2017 by IGI Publishing (an imprint of IGI Global).

182

Section 4

Cardiovascular Disease

184

Chapter 10

Pharmacogenomics and Cardiovascular Disease Emily K. Dornblaser University of New England, USA Craig P. Worby University of New England, USA Daniel Alan Brazeau University of New England, USA

ABSTRACT Cardiovascular disease is one of the most prevalent disease states in the U.S. and contributes substantially to overall morbidity and mortality. The ability to effectively optimize the treatment of cardiovascular disease has a significant impact on overall disease prevention and treatment. This chapter discusses the relationship between genetic variations and their impact on medications used for the treatment of cardiovascular disorders. Key medications that are susceptible to genetic variation have been identified. The chapter describes the mechanisms by which genetic variation may contribute to altered medication concentrations or effects and briefly reviews the place in therapy for the cardiovascular medications. In addition, this chapter reviews current clinical literature to determine the overall impact these variations may have on clinical outcomes.

INTRODUCTION The prevalence of cardiovascular disease in the United States is extensive. The American Heart Association estimates that approximately 1 in 3 American adults have at least one cardiovascular condition. Many have multiple conditions. Eighty million Americans are estimated to have hypertension, while 15 million have some form of coronary heart disease. Cardiovascular disease (CVD) encompasses a wide-variety of conditions including hypertension, hyperlipidemia, coronary heart disease, atrial fibrillation and other arrhythmias, and congestive heart failure. CVD accounts for about 30% of all deaths in the United States and is the leading cause of death for both men and women (Mozafarian et al., 2016). DOI: 10.4018/978-1-5225-7122-3.ch010

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Pharmacogenomics and Cardiovascular Disease

Evidence-based therapies of various pharmacologic agents have been shown to reduce morbidity and mortality. Commonly used agents may include beta-blockers, statins, anti-platelets, and anti-coagulants (January et al., 2014; O’Gara et al., 2013; Yancy et al., 2013). The effects of these medications may be profoundly altered by genetic variation among patients in genes responsible for drug metabolism, drug transport or the targets of the drugs themselves. The clinical implications of these genetic variations will be discussed in this chapter.

BACKGROUND It has been a little over a 15 years since the publication of the initial draft of the human genome (Venter et al. 2001; Lander et al. 2001). Estimates for the final cost to sequence the “first” human genome range from $500 million to $1 billion. Since the completion of this first genome sequencing, technologies have undergone two revolutions first with massively parallel sequencing in the 2005 and recently with nanopore sensing technologies that hold out the hope of single molecule sequencing. As these next generation sequencing technologies become readily available, genome sequencing costs has decreased and sequence yields increased exponentially. In large part due to availability of high-throughput sequencing technologies it has become possible to begin to assess and catalogue human genetic variation. In an analysis of sequence data from protein coding regions (exomes) of 60,706 individuals Lek, et al. (2016) have identified over 3,000 genes which are likely loss of function variants; importantly 72% of these identified genes have no established disease phenotype at this time. The ultimate identification and delineating of these variants in human populations are critical to understanding the underlying genetic causes of human disease and drug response. This revolution in genomic technologies as well as the attendant advances in bioinformatics has led to the appeal for prevention and treatment strategies based upon the individual characteristics of the patient, now referred to as “Precision Medicine”. The recognition that much of the variability among patients in disease severity and treatment response may soon be anticipated (and prevented) with knowledge being acquired in the new fields of genomics, metagenomics (assessment of the patient’s microbial community), metabolomics (assessment of the small molecule metabolites in biological systems) and proteomics (assessment of the patient’s proteins including enzymes, transporters, receptors) drives the development of precision medicine. Importantly, one of the more successful areas in precision medicine is in pharmacogenetics or pharmacogenomics. The two terms have been used interchangeably and have the ultimate goal of identifying the many underlying genetic factors playing a role in the efficacy or toxicity of all drugs. Pharmacogenetics traditionally considers the action of a single gene in drug response. Pharmacogenomics is the broader term and includes any and all genes and their interactions that may play a role in drug response. Pharmacogenetics/genomics has experienced more success in terms of clinical relevance as compared to success of genomics to predict disease risk because often a single gene will play a large role in drug response and is thus a much more tractable problem (Altman 2011). For virtually all medications the role of patient variability in drug response either in efficacy, toxicity or adverse reactions is well known. One aspect of patient variability is the incidence of adverse drug reactions (ADR). For example, the Institute of Medicine has estimated that there are ~1.5 million pre-

185

 Pharmacogenomics and Cardiovascular Disease

ventable adverse drug reactions in the US each year costing over 3 billion dollars (Aspden et al 2007). This represents a considerable and potentially avoidable burden on the healthcare system. Cardiovascular medications are an all too common cause of ADRs, largely due to warfarin and oral anti-platelets (Budnitz et al 2011). Additionally studies have shown that only 50-75% patients respond beneficially to the first drug administered and this rate is even lower (4%-25%) for the top ten highest-grossing drugs in the US (Schork 2015). For medications to treat cardiac arrhythmias nearly 60% of the drugs first administered provide little or no benefit (Spear et al. 2001). While it is known that much of this variation in patient response is due to factors including age, diet, drug interactions, or non-compliance the concern here is the role of genetic variation in drug response. In the cardiovascular literature there has been much interest in the role of human genetic variation in drug metabolizing enzymes, drug transporters and drug targets (Myburgh etal 2012; Weeke and Roden 2013; Johnson and Cavallari 2013). Much of what is known in the pharmacogenetics of all drugs, including cardiovascular drugs is compiled, annotated and updated daily in the Pharmacogenomics and Pharmacogenetics Knowledge Base (PharmGKB, http://www.pharmgkb.org/). PharmGKB is an integrated database providing clinical, pharmacokinetic, pharmacodynamic, genotypic, and molecular function data for human genetic polymorphisms and drugs (Klein et al. 2001; Altman et al. 2003). The stated objective PharmGKB is to “aid researchers in understanding how genetic variation among individuals contributes to differences in reactions to drugs”. The data within PharmGKB includes: 1. 2. 3. 4. 5.

Annotation of genetic variants that play a role in gene-drug-disease relationships. Excellent summaries of important “pharmacogenes” – genes involved in drug response. FDA drug labels that include pharmacogenomic information. Drug metabolism and transport pathways with links to relevant genes. Clinical annotations summarizing the role of human genetic variation in altering clinical endpoints that aid in determining medical practice or policy. 6. Publish pharmacogenomic drug dosing guidelines through the Clinical Pharmacogenetics Implementation Consortium (CPIC). Most importantly for practitioners the Clinical Pharmacogenetics Implementation Consortium (CPIC) has developed guidelines to assist health care providers with available genetic test results as they apply to the prescribing of medication (Relling and Klein, 2011). The guidelines have been organized around either genes or medications and assigned a CPIC level (A-D) based on whether there are prescribing recommendations based on the evidence (Consortium). The PharmGKB level of evidence scale provides a graded approach to currently published literature with the highest level (1A) reflecting a medical society endorsed guideline (“Clinical Annotation Levels of Evidence”). Importantly, these guidelines are intended to help clinicians understand how to use test results rather than whether the tests should be conducted or not. Table 1 details all cardiovascular medications that have CPIC guidelines as well as the level of evidence associated with each and whether there are actionable dosing recommendations. Medications that are routinely used for cardiovascular disease that have significant levels of evidence or actionable dosing recommendations are reviewed in this chapter including antiplatelet medications, lipid lowering agents, anticoagulants and beta-blockers.

186

 Pharmacogenomics and Cardiovascular Disease

Table 1. Cardiovascular medications with annotated pharmacogenetic indications based upon the Clinical Pharmacogenetics Implementation Consortium (CPIC) and the Pharmcogenomics Knowledgebase (PharmGKB) Drugs

Indication

Genes

CPIC Level

PharmGKB Level of Evidence

1

Acenocoumarol

Anticoagulant

CYP4F2

B

2B

2

Aspirin

Antiplatelet

LTC4S

D

2B

3

Atorvastatin

Statin

COQ2

D

2B

4

Carvedilol

Beta Blocker

CYP2D6

C

3

Actionable PGx

5

Clopidogrel

Antiplatelet

CYP2C19

A

1A

Genetic testing recommended

CES1

C/D

2B

6

Digoxin

Anti-arrythmic

ABCB1

C/D

2A

7

Flecainide

Anti-arrythmic

CYP2D6

C

2A

8

HMG COA Reductase Inhibitors

Statin

HMGCR

D

2A

NAT1

D

NAT2

D

CYP2D6

C

9

Isosorbide Dinitrate

Vasodilator

10

Metoprolol

Beta Blocker

PGx on FDA Label

Informative PGx 3

Informative PGx

11

Phenprocoumon

Anticoagulant

CYP4F2

B

2A

12

Propafenone

Anti-arrythmic

CYP2D6

C

2A

Actionable PGx

13

Propranolol

Beta Blocker

CYP2D6

C

4

Informative PGx

14

Rosuvastatin

Statin

ABCG2

D

2B

15

Simvastatin

Statin

16

Warfarin

Anticoagulant

COQ2

D

2B

SLCO1B1

A

1A

CYP2C9

A

1A

Actionable PGx

VKORC1

A

1A

Actionable PGx

CYP4F2

B

1B

CALU

D

2B

GGCX

D

3

PHARMACOGENETICS OF CARDIOVASCULAR DRUGS The impact of pharmacogenetic variation typically manifests in either a change in the pharmacokinetic profile of a medication or the pharmacodynamic effect of a medication. Pharmacokinetics refers to the process by which a drug moves through the body, often described by absorption, distribution, metabolism, and elimination (ADME). A pharmacogenomic alteration to liver enzyme systems (ex. CYP) may result in an increase or a decrease in the metabolism of a medication thus causing the drug to be either cleared faster or slower by the body respectively. Pharmacodynamics refers to the effect a medication has on the body. Genetic variations in target receptor complexes or intracellular signaling pathways may increase or decrease the effect of the medication.

187

 Pharmacogenomics and Cardiovascular Disease

Antiplatelet Medications (Clopidogrel, Prasugrel, Ticagrelor, Asprin) •

•

•

•

188

Mechanism of Action: Clopidogrel, prasugrel, and ticagrelor are all inhibitors of platelet P2Y12 receptors. Clopidogrel and prasugrel inhibit irreversibly while ticagrelor inhibiton is reversible. In normal functioning platelets, ADP binds to P2Y12 receptors to reduce cyclic AMP. Cyclic AMP itself inhibits platelet activation; therefore, decreasing cAMP through the P2Y12 receptor promotes activation. Clopidogrel blocks the P2Y12 receptor, increasing cAMP, and ultimately inhibiting platelet activation. Only clopidogrel has been seen to be profoundly effected by genomic variations (Weitz, 2011). Place in Therapy: Clopidogrel is frequently used for secondary prevention of stroke, acute coronary syndrome, and prevention of stent thrombosis after percutaneous coronary intervention. Clopidogrel has demonstrated efficacy in reducing rates of stroke, myocardial infarction, and death (Weitz, 2011). Genetic Variations Present: Clopidogrel is a prodrug that requires transformation in the liver via CYP2C19 to its active form. Variants in the genes encoding CYP2C19 can affect metabolism. The presence of the CYP2C19*2 loss of function variant can cause marked reductions in platelet aggregation (Hulot et al., 2006). In addition to CYP2C19*2 there are other alleles (*2-*8) segregating in patient populations that also result in reduced function. There is even one allele CYP2C19*17 that results in increased enzyme activity and potentially increased platelet inhibition (Scott, et al 2013). Implications: In January 2009, in response to reports that clopidogrel effectiveness may be reduced in some patients, the FDA initiated an investigation into the genetic factors and other drugs that may influence its effectiveness (“Early Communication about an Ongoing Safety Review of clopidogrel bisulfate (marketed as Plavix)” January 26, 2009).(“Early Communication about an Ongoing Safety Review of clopidogrel bisulfate (marketed as Plavix)” January 26, 2009). In a follow-up communication that November, the FDA recommended against the co-administration of clopidogrel with omeprazole, a CYP2C19 inhibitor. In March 2010, the FDA issued a safety warning that poor metabolizers of clopidogrel may not receive the full benefit of the medication (“FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug” March 12, 2010). This recommendation was based on a pharmacokinetic study of 40 healthy subjects that demonstrated higher doses of clopidogrel in PMs would achieve greater anti-platelet response. However, the study was not intended to assess clinical outcomes; therefore definitive recommendations could not be made (“FDA Drug Safety Communication: Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug., ” March 12, 2010). Since the FDA warning, extensive research has been conducted on the implications of CYP2C19 polymorphisms on clinical outcomes and the need for genetic testing. Genotype testing prior to initiation of clopidogrel has proven to be controversial. Clinical Pharmacogenetics Implementation Consortium (CPIC) recommended in its 2013 guidelines that consideration be given to genetic testing if the results may alter treatment (Scott et al., 2013). The American Heart Association (AHA) recommends against routine genetic testing as no RCT to date has demonstrated improved outcomes (Levine et al., 2016).. A meta-analysis of 32 studies dating from 2008-2011 published in 2011 found no difference in clinical outcomes

 Pharmacogenomics and Cardiovascular Disease

with clopidogrel use between CYP2C19 genotypes. The increase in cardiovascular events effects seen in individual studies was attributed to significant small study bias in that larger studies trended toward no difference in clinical outcomes (Holmes, Perel, Shah, Hingorani, & Casas, 2011). Recently, Doll et al. published a genetic sub-study of the TRILOGY ACS trial evaluating the effects of CYP2C19 of clopidogrel or prasugrel in medically managed patients with acute coronary syndrome on a composite primary endpoint of cardiovascular death, myocardial infarction, or stroke. Patients were classified as either extensive metabolizers (EM) or reduced metabolizers (RM). While there was a trend to toward decreased events in EMs, no statistically significant difference was found between EMs and RMs for either medication. The authors concluded that genotype testing was not supported by their findings; however, the sub-study included very few patients with 2 non-functioning alleles (Doll et al., 2016). CYP2C19 may be more important in patients undergoing PCI (Wallentin et al., 2010; Mega et al., 2010). As a result of this, the AHA suggests use of prasugrel or ticagrelor over clopidogrel in patients indicated for dual-antiplatelet therapy who have undergone coronary stenting (Levine et al., 2016).

Lipid-Lowering Drugs (Atorvastatin, Rosuvastatin, Simvastatin, HGM Co-A Reductase Inhibitors) •

•

•

•

Mechanism of Action: The drug class commonly referred to as ‘statins’ are classified as HMGCoA Reductase inhibitors. These medications inhibit the formation of mevalonate, a precursor to LDL cholesterol, and result in lower in vivo synthesis of LDL. The body responds with an upregulation of LDL receptors increasing catabolism of circulating LDL and increasing the liver’s extraction of circulating LDL precursors. The net result is a lowering of circulating LDL cholesterol levels and is one of the primary reasons these medications are utilized for many primary and secondary disease prevention strategies (Malloy & Kane, 2015). Place in Therapy: The statin medications are primarily used for the treatment and prevention of atherosclerotic cardiovascular disease (acute coronary syndromes, history of myocardial infarction, stable or unstable angina, stroke, transient ischemic attack or peripheral artery disease) and the intensity of therapy should be determined based on the 10-year ASCVD risk score of the patient and their baseline LDL-C levels (Stone et al., 2014). Genetic Variations Present: In 2008, the SEARCH collaborative group published the results of a genome wide association study to identify any major single-nucleotide polymorphism (SNP) that may be associated with the common statin side effect of myopathy. The study revealed a nonsynonymous rs4149056 SNP on the SLC01B1 gene that was associated with statin metabolism (r2=0.97). It is postulated that alterations in this gene result in a lower uptake of the statin mediation into hepatocytes resulting in higher circulating blood concentrations of the medication. Each copy of the C allele present represented an odds ratio for myopathy of 4.5 (95% CI: 2.6-7.7) and of 16.9 (95% CI: 4.7-61.1) for CC alleles compared to TT homozygotes (Link et al., 2008). Similar results were found with a gene-dose effect in an additional genome wide study published within a year of the SEARCH trial (Voora et al., 2009). Implications: In response to the SEARCH trial results, the FDA updated the prescribing guidelines for simvastatin and no longer recommend initiating therapy at doses of 80 mg of simvastatin a day (“FDA Drug Safety Communication: New restrictions, contraindications, and dose limita-

189

 Pharmacogenomics and Cardiovascular Disease

tions for Zocor (simvastatin) to reduce risk of muscle injury,” 2011). The recently published ACC/ AHA guidelines on the treatment of cholesterol identify the impact of pharmacogenetic testing as an area of future clinical consideration (Stone et al., 2014). In 2014, the Clinical Pharmacogenetics Implementation Consortium published an update to their 2012 guideline on simvastatin-induced myopathy. The consortium strongly recommends prescribing a lower dose of simvastatin or an alternative statin in patients with intermediate or low function phenotypes (Ramsey et al., 2014). The translation of genetic testing to clinical prescribing patterns has been minimal, in part because the intensity of statin dosing is the focus of clinical prescribing guidelines and has been associated with better patient outcomes. Although empiric reductions in dosing due to genetic profiling may prevent adverse events patients may not realize the clinical benefits from a lower dose of the medication. Genetic testing may have a role in guiding the selection of the initial medication rather than the initial dose as a means of reducing harm yet ensuring the benefit of the medication is realized.

Anti-Coagulants (Warfarin) •

•

•

190

Warfarin Mechanism of Action: Warfarin is an anticoagulant medication that elicits response through inhibition of the vitamin K reduction pathway. The reduced form of vitamin K is responsible for carboxylation and activation of clotting factors. Thus the enzyme vitamin K epoxide reductase (VKOR) is responsible for the reduction of vitamin K; it’s inhibition by warfarin results in a depletion of active clotting factors resulting in systemic anticoagulation (Weitz, 2011). Place in Therapy: Warfarin therapy has traditionally been the basis for nearly all anticoagulation indications including treatment of venous thromboembolism and pulmonary embolism (VTE/ PE), stroke prevention in patients with Atrial Fibrillation (AFib), secondary stroke prevention and anticoagulation for valvular disease. However, novel oral anticoagulants (NOACs)- medications that do not require routine monitoring and have fewer drug interactions- are beginning to show superiority over warfarin therapy (Guyatt, Akl, Crowther, Gutterman, & Schuünemann, 2012). In 2012, the CHEST Anticoagulation guidelines recommended dabigatran over warfarin therapy for the secondary prevention of stroke in patients with AFib (You et al., 2012). In 2016, the CHEST guidelines for VTE/PE treatment were updated and now recommend any of the NOAC medications over warfarin therapy (Kearon et al., 2016). Genetic Variations Present: The CYP 2C9 enzyme is primarily responsible for the metabolism of warfarin in the liver. Two major CYP2C9 variants *2 and *3 have been identified as having a significant impact on the overall dosing requirements for warfarin therapy due to their impact on its metabolism. The CYP enzyme variability is responsible for a pharmacokinetic effect on drug levels and patients with either variant have been found to require larger doses of warfarin (Whirl-Carrillo et al., 2012).A genetic variation in the gene responsible for VKOR enzyme activity, the VKORC1 gene, results in a pharmacodynamic effect on the medication’s activity. (Thorn) The c.-1639G>A or c.1173C>T SNP’s present in the regulatory regions of VKORC1 contribute to the variability in warfarin dosing for patient populations. Presence of the c.1639A allele results in an increased sensitivity to the effects of warfarin and therefore requires lower doses of the medications. The genotypes c.1639AA, AG, GG (or 1173TT, CT, CC) correlate to high, medium and low sensitivity to the medication (Johnson & Callavari). Implications: As the evidence for better outcomes with novel oral anticoagulants builds, the use of warfarin therapy will likely to decrease over time. In the 2012 CHEST guidelines, the routine

 Pharmacogenomics and Cardiovascular Disease

use of pharmacogenetic testing for guiding the initiation of warfarin dosing was not recommended with a strong level of evidence, that is Grade 1B (Guyatt et al., 2012). Although there is potential benefit for using genomic testing to determine warfarin dosing, the movement away from clinical use of the medication is likely to limit further studies on dosing based on genomics. It would be likely that without further studies clinical guidelines such as CHEST will not reverse their position on its utility for routine use.

β-Blockers (Carvedilol, Metoprolol, Propanolol) •

•

•

•

Mechanism of Action: Beta-blockers function by binding to beta-adrenergic receptors to competitively reduce binding of catecholamines and beta-agonists (Robertson & Biaggioni, 2015). Most agents in the class such as metoprolol and carvedilol are pure antagonists; however, some like pindolol and acebutalol act as partial agonists (Robertson & Biaggioni, 2015; Westfall & Westfall, 2011). Beta-blockers decrease heart rate, blood pressure, and myocardial oxygen consumption. Place in Therapy: Beta-blockers are used to treat a variety of diseases such as hypertension, ischemic heart disease, and atrial fibrillation. Beta-blockers are also guideline-directed therapy to reduce morbidity and mortality from myocardial infarctions and heart failure (O’Gara et al., 2013; Yancy et al., 2013). Genetic Variations: Metoprolol is extensively metabolized hepatically through CYP2D6, thus variability in the CYP2D6 genotype can lead to dramatic differences in serum concentrations between patients. Poor metabolizers can exhibit serum concentrations three to ten times extensive metabolizers (Robertson & Biaggioni, 2015). CYP2D6 is responsible for up to 60% of the metabolism of oral metoprolol (Lennard et al., 1982). Implications: CYP2D6 polymorphisms have demonstrated increased concentrations of metoprolol in poor metabolizers (Ismail & Teh, 2006; Sharp et al., 2009). A study of 52 patients demonstrated that patients with 0 to 1 functional alleles had higher serum concentrations, 6.3 times (p = 0.016) and 3.2 times (p = 0.006) respectively, than patients with 2 fully functional alleles. The study did not find a difference in HR, SBP, or DBP between any group; however, too few patients were enrolled in the 0 functional allele group to draw conclusions (Sharp et al., 2009). The clinical implications of CYP2D6 variations on the effects of metoprolol may exist over a range of outcomes. One recent trial (2014), prospectively evaluated the effects of CYP2D6 polymorphisms in patients receiving oral metoprolol at doses titrated to 100 mg twice daily. 218 patients were classified as poor metabolizers (PM), intermediate metabolizers (IM), extensive metabolizers (EM), and ultra-rapid metabolizers (UM). There was no statistically significant difference seen in the mean daily dose of metoprolol, change in systolic and diastolic blood pressure in each group, or side effects. However, the investigators did find a greater reduction in heart rate in PMs and IMs (-16.6±6.9 and -18.6±5.1) compared to EMs and UMs (-11.4±6.6 and -11.2±8.2, p = 0.0001; Hamadeh et al., 2014). As metoprolol dose is titrated to clinical effect, there is no role for pharmacogenomics in determining the dose at this time. While carvedilol is also metabolized through CYP2D6, no pharmacodynamics differences on HR, BP, or adverse effects have been noted (Baudhuin et al., 2010; Sehrt, Meineke, Tzvetkov, Gultepe, & Brockmoller, 2011).

191

 Pharmacogenomics and Cardiovascular Disease

FUTURE RESEARCH DIRECTIONS AND CONCLUSION There is now substantial pharmacogenetic evidence that could be applied to help guide patient therapy. In one recent review of cardiovascular drugs and pharmacogenomics the authors looked at 289 studies involving cardiovascular drugs and genetics (Kitsios and Kent 2012). The authors identified 289 cardiovascular studies assessing the role of pharmacogenetics in patient response. These studies identified 220 unique genetic polymorphisms in genes involved in drug metabolism, transport and drug action. Of these 9% (19) were confirmed by the authors stringent criteria to have significant associations. However, none of the 19 gene/drug associations have yet to be recommended for use in clinical practice. The authors note that this lack of clinical impact is often due to the fact that genetic testing is never likely to be more accurate in predicting patient response that direct phenotypic measures (INR for examples in warfarin dosing). In a similar study Kaufman et al. reviewed 884 drug/genetic studies involving 51 cardiovascular medications and found evidence of associations strong enough to support clinical alerts for 92 polymorphisms affecting 23 medications (Kaufman et al. 2015). They note that the lack of randomized clinical trials (RCT) has hampered the incorporation of guidelines based upon genetic tests. Such RCTs while foundational to evidence-based medicine are difficult in pharmacogenetic assessments given the cost, time and limited scope of any one allele in patient populations. Lesko et al. suggests that requirement of RCTs to demonstrate clinical utility “represents an unrealistically high evidentiary standard” (Lesko, et al. 2010). Rather RCTs along with a combination of prospective clinical trials and observational studies are needed to hasten the translation of pharmacogenetic research to medical practice (Lesko, et al. 2010). It has been argued that the standard to employ pharmacogenetic information in making clinical decisions should not be superiority to current practice. Given the ever decreasing cost of genotyping and the generally low risk of modifying therapy based upon pharmacogenetics the use of this information should be an important component of any multi-faceted decision making process guiding therapy (Altman 2011).

REFERENCES Altman, R. B. (2011). Pharmacogenomics: Noninferiority Is Sufficient for Initial Implementation. Clinical Pharmacology and Therapeutics, 89(3), 248–350. doi:10.1038/clpt.2010.310 PMID:21326263 Aspden, P., Wolcott, J., Bootman, J. L., & Cronenwett, L. R. (Eds.). (2007). Committee on Identifying and Preventing Medication Errors. Board on Health Care Services; Institute of Medicine. Preventing Medication Errors. Washington, DC: National Academies Press. Baudhuin, L. M., Miller, W. L., Train, L., Bryant, S., Hartman, K. A., Phelps, M., ... Jaffe, A. S. (2010). Relation of ADRB1, CYP2D6, and UGT1A1 polymorphisms with dose of, and response to, carvedilol or metoprolol therapy in patients with chronic heart failure. The American Journal of Cardiology, 106(3), 402–408. doi:10.1016/j.amjcard.2010.03.041 PMID:20643254 Budnitz, D. S., Lovegrove, M. C., Shehab, N., & Richards, C. L. (2011). Emergency Hospitalizations for Adverse Drug Events in Older Americans. The New England Journal of Medicine, 365(21), 2002–2012. doi:10.1056/NEJMsa1103053 PMID:22111719 Clinical Annotation Levels of Evidence. (n.d.). Retrieved from https://www.pharmgkb.org/page/clinAnnLevels

192

 Pharmacogenomics and Cardiovascular Disease

Consortium, C. P. I. Prioritization of Genes/Drugs. (n.d.). Retrieved from https://cpicpgx.org/prioritization/cpicLevels Doll, J. A., Neely, M. L., Roe, M. T., Armstrong, P. W., White, H. D., Prabhakaran, D., ... Fox, K. A. (2016). Impact of CYP2C19 Metabolizer Status on Patients With ACS Treated With Prasugrel Versus Clopidogrel. Journal of the American College of Cardiology, 67(8), 936–947. doi:10.1016/j. jacc.2015.12.036 PMID:26916483 Early Communication about an Ongoing Safety Review of clopidogrel bisulfate (marketed as Plavix). (2009). Retrieved from http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/DrugSafetyInformationforHeathcareProfessionals/ucm079520.htm FDA Drug Safety Communication. Reduced effectiveness of Plavix (clopidogrel) in patients who are poor metabolizers of the drug. (2010). Retrieved from http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm203888.htm FDA Drug Safety Communication. New restrictions, contraindications, and dose limitations for Zocor (simvastatin) to reduce risk of muscle injury. (2011). Retrieved from http://www.fda.gov/Drugs/DrugSafety/ucm256581.htm Guyatt, G. H., Akl, E. A., Crowther, M., Gutterman, D. D., & Schuünemann, H. J. (2012). Executive summary: Antithrombotic therapy and prevention of thrombosis, 9th ed: american college of chest physicians evidence-based clinical practice guidelines. Chest, 141(2), 7S-47S. doi:10.1378/chest.1412S3 Hamadeh, I. S., Langaee, T. Y., Dwivedi, R., Garcia, S., Burkley, B. M., Skaar, T. C., ... Johnson, J. A. (2014). Impact of CYP2D6 polymorphisms on clinical efficacy and tolerability of metoprolol tartrate. Clinical Pharmacology and Therapeutics, 96(2), 175–181. doi:10.1038/clpt.2014.62 PMID:24637943 Holmes, M. V., Perel, P., Shah, T., Hingorani, A. D., & Casas, J. P. (2011). CYP2C19 genotype, clopidogrel metabolism, platelet function, and cardiovascular events: A systematic review and meta-analysis. Journal of the American Medical Association, 306(24), 2704–2714. doi:10.1001/jama.2011.1880 PMID:22203539 Hulot, J. S., Bura, A., Villard, E., Azizi, M., Remones, V., Goyenvalle, C., ... Gaussem, P. (2006). Cytochrome P450 2C19 loss-of-function polymorphism is a major determinant of clopidogrel responsiveness in healthy subjects. Blood, 108(7), 2244–2247. doi:10.1182/blood-2006-04-013052 PMID:16772608 Ismail, R., & Teh, L. K. (2006). The relevance of CYP2D6 genetic polymorphism on chronic metoprolol therapy in cardiovascular patients. Journal of Clinical Pharmacy and Therapeutics, 31(1), 99–109. doi:10.1111/j.1365-2710.2006.00699.x PMID:16476126 January, C. T., Wann, L. S., Alpert, J. S., Calkins, H., Cigarroa, J. E., Cleveland, J. C. Jr, ... Yancy, C. W. (2014). 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: A report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation, 130(23), e199–e267. doi:10.1161/CIR.0000000000000041 PMID:24682347 Johnson, J. A., & Cavallari, L. H. (2013). Pharmacogenetics and Cardiovascular Disease—Implications for Personalized Medicine. Pharmacological Reviews, 65(3), 987–1009. doi:10.1124/pr.112.007252 PMID:23686351

193

 Pharmacogenomics and Cardiovascular Disease

Kaufman, A. L., Spitz, J., Jacobs, M., Sorrentino, M., Yuen, S., Danahey, K., & ODonnell, P. H. (2015). Evidence for Clinical Implementation of Pharmacogenomics in Cardiac Drugs. Mayo Clinic Proceedings, 90(6), 716–729. doi:10.1016/j.mayocp.2015.03.016 PMID:26046407 Kearon, C., Akl, E. A., Ornelas, J., Blaivas, A., Jimenez, D., Bounameaux, H., ... Moores, L. (2016). Antithrombotic therapy for vte disease: Chest guideline and expert panel report. Chest, 149(2), 315–352. doi:10.1016/j.chest.2015.11.026 PMID:26867832 Kitsios, G. D., & Kent, D. M. (2012). Personalised medicine: Not just in our genes. BMJ (Clinical Research Ed.), 344, e2161. PMID:22491484 Klein, T. E., Chang, J. T., Cho, M. K., Easton, K. L., Fergerson, R., Hewett, M., ... Altman, R. B. (2001). Integrating Genotype and Phenotype Information: An Overview of the PharmGKB Project. The Pharmacogenomics Journal, 1(3), 167–170. doi:10.1038j.tpj.6500035 PMID:11908751 Lek, M., Karczewski, K. J., Minikel, E. V., Samocha, K. E., Banks, E., Fennell, T., ... MacArthur, D. G. (2016). Analysis of protein-coding genetic variation in 60,706 humans. Nature, 536(7616), 285–291. doi:10.1038/nature19057 PMID:27535533 Lennard, M. S., Silas, J. H., Freestone, S., Ramsay, L. E., Tucker, G. T., & Woods, H. F. (1982). Oxidation phenotypea major determinant of metoprolol metabolism and response. The New England Journal of Medicine, 307(25), 1558–1560. doi:10.1056/NEJM198212163072505 PMID:7144837 Lesko, L. J., Zineh, I., & Huang, S.-M. (2010). What Is Clinical Utility and Why Should We Care? Clinical Pharmacology and Therapeutics, 88(6), 729–733. doi:10.1038/clpt.2010.229 PMID:21081937 Levine, G. N., Bates, E. R., Bittl, J. A., Brindis, R. G., Fihn, S. D., Fleisher, L. A., ... Smith, S. C. Jr. (2016). 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Journal of the American College of Cardiology, 68(10), 1082–1115. doi:10.1016/j.jacc.2016.03.513 PMID:27036918 Link, E., Parish, S., Armitage, J., Bowman, L., Heath, S., Matsuda, F., ... Collins, R. (2008). SLCO1B1 variants and statin-induced myopathya genomewide study. The New England Journal of Medicine, 359(8), 789–799. doi:10.1056/NEJMoa0801936 PMID:18650507 Malloy, M., & Kane, J. (2015). Agents used in dyslipidemia. In B. Katzung & A. Trevor (Eds.), Basic & Clinical Pharmacology. New York, NY: McGraw-Hill. Mega, J. L., Close, S. L., Wiviott, S. D., Shen, L., Walker, J. R., Simon, T., ... Sabatine, M. S. (2010). Genetic variants in ABCB1 and CYP2C19 and cardiovascular outcomes after treatment with clopidogrel and prasugrel in the TRITON-TIMI 38 trial: A pharmacogenetic analysis. Lancet, 376(9749), 1312–1319. doi:10.1016/S0140-6736(10)61273-1 PMID:20801494 Mozaffarian, D., Benjamin, E. J., Go, A. S., Arnett, D. K., Blaha, M. J., Cushman, M., ... Turner, M. B. (2016). Heart Disease and Stroke Statistics-2016 Update: A Report From the American Heart Association. Circulation, 133(4), e38–e360. doi:10.1161/CIR.0000000000000350 PMID:26673558

194

 Pharmacogenomics and Cardiovascular Disease

Myburgh, R., Hochfeld, W. E., Dodgen, T. M., Ker, J., & Pepper, M. S. (2012). Cardiovascular pharmacogenetics. Pharmacology & Therapeutics, 133(3), 280–290. doi:10.1016/j.pharmthera.2011.11.002 PMID:22123178 OGara, P. T., Kushner, F. G., Ascheim, D. D., Casey, D. E. Jr, Chung, M. K., de Lemos, J. A., ... Zhao, D. X. (2013). 2013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines: developed in collaboration with the American College of Emergency Physicians and Society for Cardiovascular Angiography and Interventions. Catheterization and Cardiovascular Interventions, 82(1), E1–E27. doi:10.1002/ccd.24776 PMID:23299937 Ramsey, L. B., Johnson, S. G., Caudle, K. E., Haidar, C. E., Voora, D., Wilke, R. A., ... Niemi, M. (2014). The clinical pharmacogenetics implementation consortium guideline for SLCO1B1 and simvastatininduced myopathy: 2014 update. Clinical Pharmacology and Therapeutics, 96(4), 423–428. doi:10.1038/ clpt.2014.125 PMID:24918167 Relling, M. V., & Klein, T. E. (2011). CPIC: Clinical Pharmacogenetics Implementation Consortium of the Pharmacogenomics Research Network. Clinical Pharmacology and Therapeutics, 89(3), 464–467. doi:10.1038/clpt.2010.279 PMID:21270786 Robertson, D., & Biaggioni, I. (2015). Adrenoceptor Antagonist Drugs. In B. Katzung & A. Trevor (Eds.), Basic & Clinical Pharmacology. New York, NY: McGraw-Hill. Schork, N. J. (2015). Personalized medicine: Time for one-person trials. Nature, 520(7549), 609–611. doi:10.1038/520609a PMID:25925459 Scott, S. A., Sangkuhl, K., Stein, C. M., Hulot, J. S., Mega, J. L., Roden, D. M., ... Shuldiner, A. R. (2013). Clinical Pharmacogenetics Implementation Consortium guidelines for CYP2C19 genotype and clopidogrel therapy: 2013 update. Clinical Pharmacology and Therapeutics, 94(3), 317–323. doi:10.1038/ clpt.2013.105 PMID:23698643 Sehrt, D., Meineke, I., Tzvetkov, M., Gultepe, S., & Brockmoller, J. (2011). Carvedilol pharmacokinetics and pharmacodynamics in relation to CYP2D6 and ADRB pharmacogenetics. Pharmacogenomics, 12(6), 783–795. doi:10.2217/pgs.11.20 PMID:21599570 Sharp, C. F., Gardiner, S. J., Jensen, B. P., Roberts, R. L., Troughton, R. W., Lainchbury, J. G., & Begg, E. J. (2009). CYP2D6 genotype and its relationship with metoprolol dose, concentrations and effect in patients with systolic heart failure. The Pharmacogenomics Journal, 9(3), 175–184. doi:10.1038/ tpj.2009.9 PMID:19365402 Spear, B. B., Heath-Chiozzi, M., & Huff, J. (2001). Clinical application of pharmacogenetics. Trends in Molecular Medicine, 7(5), 201–204. doi:10.1016/S1471-4914(01)01986-4 PMID:11325631 Stone, N. J., Robinson, J. G., Lichtenstein, A. H., Bairey Merz, C. N., Blum, C. B., Eckel, R. H., ... Wilson, P. (2014). 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology, 63(2525 Pt B), 2889–2934. doi:10.1016/j.jacc.2013.11.002 PMID:24239923

195

 Pharmacogenomics and Cardiovascular Disease

Voora, D., Shah, S. H., Spasojevic, I., Ali, S., Reed, C. R., Salisbury, B. A., & Ginsburg, G. S. (2009). The SLCO1B1*5 genetic variant is associated with statin-induced side effects. Journal of the American College of Cardiology, 54(17), 1609–1616. doi:10.1016/j.jacc.2009.04.053 PMID:19833260 Wallentin, L., James, S., Storey, R. F., Armstrong, M., Barratt, B. J., Horrow, J., ... Becker, R. C. (2010). Effect of CYP2C19 and ABCB1 single nucleotide polymorphisms on outcomes of treatment with ticagrelor versus clopidogrel for acute coronary syndromes: A genetic substudy of the PLATO trial. Lancet, 376(9749), 1320–1328. doi:10.1016/S0140-6736(10)61274-3 PMID:20801498 Weeke, P., & Roden, D. M. (2013). Pharmacogenomics and Cardiovascular Disease. Current Cardiology Reports, 15(7), 376. doi:10.100711886-013-0376-0 PMID:23689943 Weitz, J. (2011). Blood Coagulation and Anticoagulant, Fibrinolytic, and Antiplatelet Drugs. In L. Brunton, B. Chabner, & B. Knollmann (Eds.), Goodman & Gilman’s: The Pharmacologic Basis of Therapeutics. New York, NY: McGraw-Hill. Westfall, T., & Westfall, D. (2011). Adrenergic Agonists and Antagonists. In L. Brunton, B. Chabner, & B. Knollmann (Eds.), Goodman & Gilman’s: The Pharmacologic Basis of Therapeutics. New York, NY: McGraw-Hill Whirl-Carrillo, M., McDonagh, E., Hbert, J., Gong, L., Snghkul, K., Thron, C., ... Klein, T. E. (2012). Pharmacogenomics Knowledge for Personalized Medicine. Clinical Pharmacology and Therapeutics, 92(4), 414–417. doi:10.1038/clpt.2012.96 PMID:22992668 Yancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Casey, D. E. Jr, Drazner, M. H., ... Wilkoff, B. L. (2013). 2013 ACCF/AHA guideline for the management of heart failure: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines. Journal of the American College of Cardiology, 62(16), e147–e239. doi:10.1016/j.jacc.2013.05.019 PMID:23747642 You, J. J., Singer, D. E., Howard, P. A., Lane, D. A., Eckman, M. H., Fang, M. C., & Lip, G. Y. H. (2012). Antithrombotic therapy for atrial fibrillation: Antithrombotic therapy and prevention of thrombosis, 9th ed: American college of chest physicians evidence-based clinical practice guidelines. Chest, 141(2), e531S-e575S. doi:10.1378/chest.11-2304

KEY TERMS AND DEFINITIONS CPIC Levels: A or B Prescribing action recommended, alternative therapies or dosing are highly likely to be effective and safe. C: No prescribing action recommended, alternatives are unclear, but testing is common. D: No prescribing action recommended, alternatives are unclear or evidence is weak; testing is rare or nonexistent. Genome: The genome of an organism encompasses all the genetic material in the cell. In humans this would include the 3 billion bases pairs contained in the chromosomes in the nucleus and the approximately 16,000 base pairs of the mitochondria. Genotype: The underlying genetic constitution of an individual usually in relation to a specific trait.

196

 Pharmacogenomics and Cardiovascular Disease

Mechanism of Action: The mechanism by which a medication alters physiology to elicit a response. Mechanisms of action are often described by the manner in which a drug binds to a target receptor (agonist/antagonist). It may be described by enzymatic activity or intracellular action. Pharmacodynamics: The effect of a drug on a body. The pharmacodynamics of a medication is dependent on the mechanism of action of the medication. Pharmacogenetics: The study of the role of genetic variation in determining individual drug response. Generally, pharmacogenetics has been limited to the effects of one or a few genes. Pharmacogenomics: The study of the genome-wide role of human variation in drug response. Pharmacogenomics is a broader term and includes pharmacogenetic effects. Pharmacogenomics also includes the application of genomic technologies in drug discovery, disposition and function. Pharmacokinetics: The process by which a drug is absorbed, distributed, metabolized and eliminated after it enters the body. Pharmacokinetics describes how a medication moves through the body and therefore impacts the overall concentration, location, and duration of a medication and its effects. PharmaGKB Level of Evidence: 1A/1B: High, CPIC guideline or known clinical implementation. 2A/2B: Moderate, variant-drug combination with moderate evidence of an association. 3: Low, Annotation for a variant-drug combination based on a single significant (not yet replicated) or annotation for a variant-drug combination evaluated in multiple studies but lacking clear evidence of an association. 4: Annotation based on a case report, non-significant study or in vitro, molecular or functional assay evidence only. Phenotype: The observable outcome of the interaction of an individual’s genes and environmental factors. Polymorphic: A gene or locus is polymorphic if there are differences among individuals in its DNA sequence or length. Generally, the specific difference must have a frequency of 5% in the population to be considered polymorphic.

This research was previously published in Emerging Applications, Perspectives, and Discoveries in Cardiovascular Research edited by Ashim Malhotra and Shivani Soni, pages 161-174, copyright year 2017 by Medical Information Science Reference (an imprint of IGI Global).

197

198

Chapter 11

Coronary Heart Disease Prognosis Using MachineLearning Techniques on Patients With Type 2 Diabetes Mellitus Angela Pimentel FCT-UNL, Portugal

Pedro Matos APDP-ERC, Portugal

Hugo Gamboa FCT-UNL, Portugal

Rogério T. Ribeiro APDP-ERC, Portugal

Isa Maria Almeida APDP-ERC, Portugal

João Raposo APDP-ERC, Portugal

ABSTRACT Heart diseases and stroke are the number one cause of death and disability among people with type 2 diabetes (T2D). Clinicians and health authorities for many years have expressed interest in identifying individuals at increased risk of coronary heart disease (CHD). Our main objective is to develop a prognostic workflow of CHD in T2D patients using a Holter dataset. This workflow development will be based on machine learning techniques by testing a variety of classifiers and subsequent selection of the best performing system. It will also assess the impact of feature selection and bootstrapping techniques over these systems. Among a variety of classifiers such as Naive Bayes (NB), Random Forest (RF), Support Vector Machine (SVM), Alternating Decision Tree (ADT), Random Tree (RT) and K-Nearest Neighbour (KNN), the best performing classifier is NB. We achieved an area under receiver operating characteristics curve (AUC) of 68,06% and 74,33% for a prognosis of 3 and 4 years, respectively.

DOI: 10.4018/978-1-5225-7122-3.ch011

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

1. INTRODUCTION About 387 million people worldwide have diabetes. In 2014 diabetes was the direct cause of 4.9 million deaths (WHO, 2015). The prevalence of diabetes is increasing in developed and developing countries and is predicted to achieve 7,7% worldwide by 2030 (Shaw, 2010). Within Europe, Portugal is reported as having the highest prevalence of diabetes. Over 1 million Portuguese have diabetes, with almost half of these still undiagnosed (Gardete‐Correia, 2010). Diabetes increases the risk of heart disease and stroke. In a multinational study, 50% of people with type 2 diabetes (T2D) die of cardiovascular disease (primarily heart disease and stroke) (Morrish, 2001). The cardiovascular events associated with T2D and the high incidence of other macrovascular complications, such as peripheral vessel disease and amputations, are a major burden of disease and a huge economic determinant. Clinicians and health authorities for many years have expressed interest in identifying individuals at increased risk of CHD. The underlying cause of CHD is a slow buildup of plaques after fatty deposits on the inner wall of the blood vessels that supply the heart muscle with blood (the coronary arteries). These fatty deposits gradually obstruct the arteries, sometimes clogging them and subsequently reduce the flow of blood to the heart. There is no single cause for CHD, but there are risk factors that increase the chance of developing it. A useful clinical diagnostic tool for following cardiac diseases evolution is with the electrocardiogram (ECG)-Holter records. Long term Holter monitoring is used for patients with heart conditions such as arrhythmias. Heart beats with unusual timing or unusual ECG morphology can be very helpful in early diagnosis of hearts with damaged electrophysiology. In clinical training and practice, prognosis typically receives less attention than diagnosis and disease treatment. Yet many clinical decisions are not fully useful unless the patient’s prognosis is considered (Gill, 2012) (Lan, 2012). The healthcare industry has generated large amounts of data, driven by record keeping, compliance and regulatory requirements, and patient care (Raghupathi, 2016). With the potential to improve the quality of healthcare delivery, while reducing costs, these massive quantities of data (known as ’big data’) supports a wide range of medical and healthcare functions, which includes clinical decision support, disease surveillance, and population health management. (Burghard, 2012). Machine learning enables the extraction of implicit, previous unknown and potentially useful information from data (Witten, 2011). With machine learning techniques, supervised or unsupervised methods are applied in order to extract and evaluate data patterns which can be used to take better decisions and to present the knowledge we extracted in a better way. This paper proposes a new prognostic approach of CHD for T2D patients based on a Holter dataset. This approach, based on machine learning methods, supports the applicability of using the Holter dataset, to efficiently predict T2D patients that are likely to develop CHD. We also highlight the importance of using feature selection algorithms for the construction of our predictive model. A drawback of this study is the low number of patients that evolve to CHD, therefore the use of boostrapping technique. The result is a prognostic tool that allows the identification of high-risk subjects in the diabetic population. The entire data set captures 8 years (2006-2014) of clinical visits, and a CHD prognosis can be made with intervals for time windows of 3 and 4 years, with AUC values of 68,06% and 74,33%, respectively using a Naïve Bayes classifier. We also show that our predictive model outperforms the Framingham study (D’Agostino, 2000) for this population. We present a solution with a higher number of features than the

199

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

Framingham, but with a higher precision on the prognostic of the CHD. We present a novel work that provides a risk indicator of CHD in T2D patients just by performing a Holter exam. Ultimately, our goal is to improve clinical decision making, and, ultimately patient clinical outcomes.

2. DATA AND METHODS 2.1. Dataset Monitoring the ECG during normal activity using Holter devices is a standard procedure for detection of cardiac arrhythmias, transient ischemic episodes and silent myocardial ischemia (Jovanov, 1999). ECG-Holters are portable, battery operated, devices for monitoring ECG signals (Levin, 1986). Ambulatory ECGHolter recordings were made with a 7-electrode recorder for 24 hours and with 10 mVolts resolution. This dataset contains 8 years (2006-2014) of clinical visits at the APDP – Diabetes Portugal. A total of 711 Holters were used for this analysis of T2D patients, with ages between 23 and 89 years. We only used patients that performed the Holter more than once since it will allow us to apply a temporal analysis as future work. Overall, 505 are male and 206 are female. The following coronary heart diseases were the only ones present in the dataset and were considered for analysis: coronary disease, ischemic cardiopathy, myocardial infarction and coronary insufficiency (decreased supply of blood to the myocardium resulting from constriction or obstruction of the coronary arteries, but not accompanied by necrosis of the myocardial cells). In order to provide a prognosis analysis, the year of diagnosis of the CHD is fundamental. However this information was not available on the Holter dataset, requiring an extensive inspection on each patient clinical file in order to obtain this parameter. Afterwards, the dataset was rearranged to provide a prognosis on different time windows. Prognostic windows between 0 to 4 years spaced by one year were selected in order to be comparable with the Framingham study. Two classes were defined: CHD that manifests in T2D patients during a defined time window and CHD that does not manifest in T2D patients. Also, any data that was obtained after the diagnosis was discarded, since it was irrelevant for the prognosis analysis. This reduced our dataset to 597 Holters. Table I shows the class distributions for the different time windows used. It is also important to mention that these patients performed the ECGHolter because they already had some symptoms that could indicate the presence of a cardiac disease. Authorization to access the data was obtained from the APDP internal Ethics Committee. Data collection was performed by the clinical staff. Confidentiality of individual data was ensured. Table 1. Class distributions for different time windows. Number of patients that evolve (evolution) and do not evolve (no evolution) to CHD condition. For each time window, there are a total of 597 holters.

200

Window (Years)

Evolution

No Evolution

0

15(2.51%)

582(97.49%)

1

31(5.19%)

566(94.81%)

2

42(7.04%)

555(92.96%)

3

49(8.21%)

548(91.79%)

4

52(8.71%)

545(91.29%)

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

2.2. Feature Extraction We proceeded to the feature extraction in order to provide an informative dataset to the classification. The Holter device provides time and frequency parameters that contribute for the prognosis of CHD. Some of the features are: heart rate; number of bradycardias, tachycardia, missed beats, pauses, bigeminy and trigeminy; square root of the mean squared difference (RMSSD) between adjacent RR intervals; standard deviation of RR intervals (SDNN); very low frequency (VLF); low frequency (LF) and high frequency (HF); We have divided the dataset preparation in three major steps as seen in Figure 1: 1) dataset confirmation; 2) redundant parameters cleaning and 3) addition of new features. In step 1, age was confirmed with the exam date and birth date performed; gender was confirmed with the patient ID; pacemaker was confirmed with features that provide pacemaker rhythm. In step 2, 40 features were not considered for having unique values for all patients which would be redundant for the classification analysis. In step 3 new features were included in the dataset. Medication was described in the dataset as a comment and sometimes with misspelling. Therefore we extended each medication name according to their active principle level as a new feature with binary values, where 1 means medication is being taken by the patient; we also created 4 groups of medications: statins, antiplatelet agents, beta-blockers and antiarrhythmics. Overall 145 features for medications were included and confirmed with the National Authority of Medicines and Health Products, IP (INFARMED) (INFARMED, 2015); bradycardia and tachycardia are classified if the heart rate is under 60 bpm and above 100 bpm respectively. Frequency values between those limits are not characterized for this analysis. Therefore we created 4 new features that groups the frequencies from 60 to 100 bpm with a step of 10 bpm. In the end, the data comprises information from 2006 to 2014 with the evolution feature as our target class as described in II-A. The training set will be represented by 70% of the original data, and the testing set with the remaining data (30%). There are 241 features for 579 Holters recordings. The programming language used for this processing was Python.

2.3. Classification After preprocessing the data we proceeded to the CHD diabetes prognosis by assessing different classifiers. Standard classifiers were used. These include: Naive Bayes (NB) (John, 1995), Alternating Decision Tree (ADT) (Freund, 1999), Random Forest (RF) (Breiman, 2001), Random Tree (RT), k-Nearest Neighbour (KNN) (Aha, 1991) and Support Vector Machine (SVM) with a polynomial kernel implementation and complexity parameter 1 (Platt, 1998). These classifiers were selected in order to assess different models: numerical (SVM), symbolic (ADT,RF,RT), instance-based (KNN) and probabilistic (NB). The predictive models were built using 5x10-fold cross-validation (CV) with random seeds (1,11,21,31,41) on the training data (Kohavi, 1995). The classifier’s parameters were optimized using a meta-classifier that performs CV given a list of possible parameters (Kohavi, 1997). Also, Figure 1. Feature extraction scheme for data preparation

201

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

knowing that the classes are unbalanced, we used another technique - Bootstrapping. This technique is applied in each CV train fold and produces random sub-samples of the dataset with replacement to bias the class distribution toward a uniform distribution. We also tested other techniques, such as Synthetic Minority Over-sampling Technique (SMOTE) (Chawla, 2011) that is responsible for over-sampling the minority class by creating synthetic examples. However, bootstrapping performed better. Final classification is based on a mid-point threshold (50%) on the probability output by the classifier. Due to the unbalanced dataset and according to (Grzymala-Busse, 2005), better sensitivity values can be achieved by changing this threshold. Therefore we also improved the sensitivity outcomes by changing this threshold to 45%. Given the high number of used features in this study (241), we proceeded to a feature selection (FS) analysis in order to verify if, in fact, some of the original features would be discarded as being irrelevant to the classification. The correlation-based feature selection (CfsSubsetEval) evaluator was used with a Best First search method from the Weka package. This algorithm evaluates the worth of a subset of attributes by considering the individual predictive ability of each feature along with the degree of redundancy between them. The Weka machine learning package was used to test the machine learning algorithms (Hall, 2009).

2.4. Comparison With Framingham In order to confirm that our risk assessment outcome provides practicable results, the outcomes were compared with the Framingham Heart Study - a risk assessment tool for CHD. The objective of the Framingham Heart Study was to identify the common factors or characteristics that contribute to cardiovascular disease (CVD) by following its development over a long period of time in a large group of participants who had not yet developed overt symptoms of CVD or suffered a heart attack or stroke (D’Agostino, 2000). There are different risk functions, however we used the CHD - second event function, which provides a risk prediction probability estimates for any time between 0 to 4 years. The predictive factors for man are: 1) age; 2) systolic blood pressure (SBP); 3) smoking status; 4) fasting lipid levels (total and HDL cholesterol); 5) physician diagnosis of diabetes at the current or a previous examination; 6) use of antihypertensive medication (yes/no). The predictive factors for women are the same as man with the addition of: 7) menopause (yes/no); 8) alcohol consumption (oz/week) and 9) triglycerides; other existing tools were found in the literature (HeartScore (Heartscore, 2015), QRISK (QRISK, 2015), ASSIGN (Assign score, 2015)), however, these are 10-year risk tools, for which we do not have enough longitudinal data for comparison. The disadvantage of using the Framingham tool is that it is based on a population from the United States, meaning that the risk functions are not adapted for the Portuguese population. As future work, we intend to update our risk assessment outcome to provide a prognosis of 10 years and then compare with the HeartScore tool, which is based in an European population and has been already approved by the Portuguese Directorate-General of Health (DGS). To summarize, in our workflow we tested different classifiers for different time windows on the original data (OD) and on the selection features (FS) from the dataset. Bootstrapping was applied in order to provide a more balanced training data. Regarding performance evaluation, several metrics were retrieved, such as the receiver operating characteristic (ROC) area (AUC), sensitivity and specificity (Fawcett, 2006). Afterwards, the best classifier was chosen based on the best metrics obtained and applied on the test data. Comparison with an existing CHD risk tool was made - the Framingham Heart Study risk tool. Our predictive model will then allow a prognostic of CHD in T2D patient’s when a new Holter is performed. 202

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

3. RESULTS AND DISCUSSION In this section we present and discuss the results of the predictive models on the training set (70% of initial dataset). Afterwards we show the performance evaluation of the best predictive model on the test set (remaining 30%) and compare our probability outputs with the Framingham study. Given that the classes are unbalanced (see Table 1), stratification was ensured when splitting the training and testing set.

3.1. Training Set The results are shown in Tables 2, 3 and 4, for the AUC, sensitivity and specificity, respectively, after applying 5 x 10-fold CV on the training set for different classifiers. The bold values represent percentages higher than 70%. We notice that the classifiers behave as random predictors of CHD for time windows of 0 and 1 year, since the AUC values are near 50%. Even though AUC values improve with increasing Table 2. AUC values obtained from the train set in percentage (stratified 5 x 10-fold CV). OD is original data; FS is after applying feature selection; RF is Random Forest. NB is Naive Bayes. SVM is Support Vector Machine. ADT is Alternating Decision Tree. RT is Random Tree and KNN is K-Nearest Neighbour. AUC (%) Window (Years)

Bootstrapping No

0 Yes No 1 Yes No 2 Yes No 3 Yes No 4 Yes

Data

RF

NB

SVM

ADT

RT

KNN

OD

57.02±6.55

47.97±0.28

50.0±0.0

68.71±1.71

50.5±12.23

55.81±3.5

FS

38.44±2.98

54.49±0.29

50.0±0.0

34.58±0.42

33.95±0.39

33.86±0.44

OD

66.89±7.87

77.25±0.99

49.64±0.11

50.91±8.03

53.82±7.67

61.02±4.05

FS

26.29±4.0

73.98±0.31

67.31±4.08

35.8±7.57

25.73±4.64

29.96±5.18

OD

55.2±2.37

56.56±0.43

50.0±0.0

53.48±2.94

50.0±3.08

62.01±1.6

FS

56.28±2.17

62.26±0.95

50.0±0.0

39.81±1.35

57.94±1.49

57.5±1.82

OD

60.31±4.14

64.45±1.73

54.43±1.36

67.21±6.11

54.58±2.15

62.87±4.71

FS

61.0±1.91

70.26±1.72

59.28±0.92

52.41±2.95

54.34±3.45

62.72±1.28

OD

50.45±4.2

60.4±0.67

50.0±0.0

48.92±5.63

51.32±2.7

60.05±2.35

FS

55.35±0.91

59.4±1.62

49.96±0.77

54.87±3.37

54.22±1.53

54.21±1.87

OD

62.7±4.02

68.35±1.44

56.28±1.87

69.96±4.12

53.73±5.21

62.69±4.24

FS

78.38±1.05

83.76±0.73

70.25±1.84

79.83±2.01

63.59±3.1

83.17±1.2

OD

57.27±2.31

67.09±1.58

50.16±0.59

80.29±1.41

51.67±3.34

68.73±1.78

FS

68.64±0.89

80.21±0.78

50.0±0.0

78.59±0.4

58.97±3.99

79.0±0.96

OD

67.28±3.19

71.27±1.57

63.36±3.44

77.92±2.37

53.59±2.28

69.99±6.59

FS

72.43±1.36

82.35±1.12

65.73±1.5

83.01±1.83

62.95±2.55

72.34±2.93

OD

58.62±3.25

66.53±1.33

50.87±0.95

77.38±2.48

57.25±4.59

65.61±3.1

FS

70.8±0.68

80.38±1.62

50.0±0.0

78.27±1.92

62.93±3.15

78.21±2.71

OD

69.45±2.91

74.36±1.53

61.19±2.68

75.11±2.53

58.16±3.99

66.44±3.1

FS

74.39±1.44

83.89±1.29

68.87±1.17

82.46±1.8

67.49±3.0

74.78±1.44

203

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

Table 3. Sensitivity values obtained from the train set in percentage (stratified 5 x 10-fold CV). OD is original data; FS is after applying feature selection; RF is Random Forest. NB is Naive Bayes. SVM is Support Vector Machine. DT is Alternating Decision Tree. RT is Random Tree and KNN is K-Nearest Neighbour. Sensitivity (%) Window (Years)

Bootstrapping No

0 Yes No 1 Yes No 2 Yes No 3 Yes No 4 Yes

Data

RF

NB

SVM

ADT

RT

KNN

OD

0.0±0.0

0.0±0.0

0.0±0.0

0.0±0.0

0.0±0.0

20.0±6.13

FS

0.0±0.0

0.0±0.0

0.0±0.0

0.0±0.0

0.0±0.0

0.0±0.0

OD

0.0±0.0

77.5±5.0

0.0±0.0

5.0±6.13

25.0±13.7

10.0±5.0

FS

12.5±7.91

65.0±5.0

45.0±6.13

7.5±6.13

7.5±10.0

20.0±6.13

OD

0.0±0.0

12.39±2.34

0.0±0.0

0.0±0.0

1.91±2.34

0.0±0.0

FS

0.0±0.0

0.0±0.0

0.0±0.0

0.0±0.0

0.0±0.0

0.0±0.0

OD

16.2±2.34

79.05±3.81

12.39±2.34

37.15±7.62

41.91±5.56

54.29±8.84

FS

68.58±2.34

45.72±2.34

29.53±1.91

18.1±5.56

58.1±7.0

33.34±0.0

OD

0.0±0.0

16.56±1.38

0.0±0.0

2.07±4.14

4.83±1.69

6.9±3.78

FS

2.07±1.69

0.0±0.0

0.69±1.38

0.0±0.0

2.07±1.69

0.0±0.0

OD

33.11±7.11

77.94±1.69

18.63±3.52

51.73±7.56

44.83±9.51

45.52±4.03

FS

46.21±6.4

80.0±2.59

46.21±3.52

86.21±2.19

41.38±6.17

88.28±2.76

OD

0.0±0.0

15.43±1.4

0.58±1.15

8.58±3.62

5.15±2.14

18.29±6.67

FS

5.15±2.14

16.0±1.4

0.0±0.0

3.43±2.14

7.43±2.29

0.58±1.15

OD

36.58±7.54

76.0±2.92

33.72±7.1

74.86±6.86

40.58±4.2

58.29±8.97

FS

59.43±3.34

72.58±1.4

49.15±4.2

85.15±7.96

59.43±3.34

66.29±4.2

OD

0.53±1.06

17.37±2.11

2.11±1.97

18.95±2.58

7.37±4.22

20.53±3.07

FS

4.22±3.16

10.53±1.67

0.0±0.0

12.11±4.28

10.53±2.36

0.0±0.0

OD

38.95±3.07

81.58±1.67

31.06±5.87

54.22±7.92

47.9±5.37

53.16±1.06

FS

64.22±2.69

79.48±3.07

54.74±1.06

72.11±4.28

64.22±3.57

75.79±6.95

time windows, we wanted to ensure that this improvement was not accidental. Therefore, for this test, we edit the evolution class by randomly selecting who will develop CHD. The AUC values for all classifiers were near 50,21±2,74%, meaning the classifiers lost their predictive ability. Hence we can validate this improvement. Also, according to (Cook, 2008), AUC values for models predicting 10 years risk of CHD are often in a range of 75 - 85%. Therefore we suggest that time windows higher than 3 years are preferred for the prognosis of CHD with this dataset. Regarding the remaining time windows, the low classification outcomes may be justified by the exclusive use of a holter dataset, that may not be sufficient to provide a prognostic in a short time. Therefore we believe that with the inclusion of more features, that are independent of the holter dataset (e.g x-ray, blood tests), we could improve this prognostic outcomes for these time windows. Sensitivity values from Table 3 are highly improved with bootstrapping for all classifiers, although specificity decreases - Table 4.

204

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

Table 4. Specificity values obtained from the train set in percentage (stratified 5 x 10-fold CV). OD is original data; FS is after applying feature selection; RF is Random Forest. NB is Naive Bayes. SVM is Support Vector Machine. DT is Alternating Decision Tree. RT is Random Tree and KNN is K-Nearest Neighbour. Specificity (%) Window (Years)

Bootstrapping No

0 Yes No 1 Yes No 2 Yes No 3 Yes

4

No Yes

Data

RF

NB

OD

100.0±0.0

98.4±0.12

FS

99.96±0.1

100.0±0.0

OD

97.18±0.4

60.83±0.25

FS

98.35±0.29

90.25±0.71

OD

99.9±0.21

FS

100.0±0.0

OD FS

SVM

ADT

RT

KNN

100.0±0.0

99.96±0.1

99.27±0.27

96.69±0.12

100.0±0.0

100.0±0.0

99.91±0.2

99.91±0.2

99.27±0.22

87.61±1.29

77.86±2.83

89.08±1.12

89.61±3.46

96.0±0.83

98.98±0.55

99.27±0.01

96.18±0.11

100.0±0.0

98.85±0.47

96.98±0.23

99.25±0.32

99.45±0.11

100.0±0.0

99.1±0.21

99.85±0.31

99.8±0.3

89.12±1.16

44.94±0.81

96.48±1.0

84.14±1.58

64.99±5.29

69.43±1.13

49.63±2.81

88.17±0.93

89.02±0.61

85.9±1.05

55.47±4.84

87.66±0.43

OD

99.85±0.13

95.63±0.37

100.0±0.0

97.74±0.6

96.56±0.93

94.92±0.77

FS

98.87±0.21

98.82±0.27

99.23±0.29

99.08±0.63

98.36±0.27

99.65±0.13

OD

85.04±1.12

51.01±1.95

93.94±1.03

77.13±2.49

65.66±3.46

80.67±1.51

FS

89.31±0.79

68.44±0.48

94.3±0.53

65.56±1.69

86.28±0.71

68.33±1.1

OD

99.69±0.11

95.57±0.44

99.74±0.29

98.07±0.86

95.15±0.87

93.69±0.45

FS

98.02±0.27

98.54±0.27

100.0±0.0

97.66±0.97

95.88±1.38

99.59±0.32

OD

82.88±1.34

54.1±2.14

93.01±1.37

67.58±1.6

65.38±4.57

80.53±1.59

FS

75.78±1.07

74.94±1.0

82.3±1.72

67.05±1.79

66.48±2.22

73.63±1.0

OD

99.85±0.22

95.0±0.8

99.64±0.27

95.95±1.08

93.85±0.66

93.27±0.72

FS

97.53±0.62

98.01±0.13

100.0±0.0

97.43±0.43

94.79±1.06

99.74±0.34

OD

82.27±1.15

53.43±0.73

91.32±0.69

84.48±1.66

66.95±4.61

79.27±1.2

FS

76.74±2.44

67.95±0.94

83.0±2.55

78.9±2.26

68.85±2.29

64.37±1.86

However, improvements on sensitivity values are preferred, since this metric represents the percentage of T2D patients correctly identified among all patients that will develop CHD. Overall NB presents better results. It is also visible that classification improves with FS for the NB classifier. The main features selected by the CfsSubsetEval evaluator with a BestFirst search are visible in Table 5 for different time windows, indicating that the isolated supraventricular ectopic beats events (SVPB) is the most important parameter for time windows of 3 and 4 years. Performance between each time window was made with a Friedman test (Demšar, 2008). Statistically significant differences occurred between the different time windows. Using pairs comparison, with significance values corrected for multiple testing, we found that windows 2 to 4 performed significantly better than the remaining ones. And, according to the mean test rank, the top performance window was for a 4-years prognosis. Statistical comparisons were also made between each data type with a Wilcoxonsigned rank test as suggested from (Demšar, 2008) for 3and 4 years’ time windows. We found that the

205

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

Table 5. Features selected from the CfsSubsetEval evaluator with a BestFirst search for the different time windows. SVPB is isolated supraventricular ectopic beats events. SVBG is number of bigeminy supraventricular events. VPB is isolated ventricular ectopic beats events. V run is the number of runs of ventricular ectopic beats events. V. Bigeminy is bigeminy ventricular events. V. Trigeminy is trigeminy ventricular events. Max H.R. is maximum heart rate (bpm). Night: HR is heart rate in bpm during the night. Night: VarIndex is the percentage of delta of RR, where deltaRR: RR(i) - R(i - 1). SVBG is the number of bigeminy supraventricular event. Selected Features 0

1

2

3

4

Clopidrogel

VPB

Age

SVPB

SVPB

VRun

clopidrogel

SVBg

Age

Age

Indapamida

Canef

V.Bigeminy

SVBg

SVBg

Actonel

Varimine

clopidrogel

Max. H.R.

V.Trigeminy

Zanitek

Varimine

Max H.R.

V.Trigeminy

Max. H.R

Aprovel

Aprovel

Adalat

clopidrogel

Clopidrogel

Actonel

Canef

Night: HR

Night: HR

Zanitek

Varimine

adalat

Night: VarIndex

indapamida

canef

24h QT Lead B Total QRS

diclofenac

varimine

Adalat

Zanitek

triatec

Canef

Actonel

diclofenac

Varimine

dancor

Triatec

zanitek

Diclofenac

actonel

Zanitek Dancor Actonel

use of the bootstrapping technique statistically significant improves the AUC values (p ≤ 0,042). In order to compare the performance of the different classifiers, we applied the Friedman test, suggested in (Demšar, 2008), using the IBM SPSS Statistics Editor. The results show that there are statistically significant differences between the classifiers for the AUC values. We analyzed the pairs comparison, with significance values corrected for multiple testing and found that the NB, ADT and KNN performed significantly better than SVM and RT (p ≤ 0,006). Moreover we verified that the top performing classifier, according to the mean test rank, was NB. We have chosen the NB for the construction of our predictive model due to its performing metrics outputs and statistical analysis. However, this classifier has other advantages: it is virtually non-parametric, and returns a numerical confidence on the result, which can be used by the clinician as a risk measure. We also wish to highlight that this Bayesian approach has already been used in this area (Lee, 2016) (Orphanou, 2016). For these reasons, we proceeded to the test set with the NB classifier.

206

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

3.2. Test Set After choosing the best classifier based on the training set, we proceeded to analyze its performance on the test set. The entire training set was used on the NB classifier to build our predictive model and then the test set was used and the AUC, sensitivity and specificity metrics were retrieved as seen in Table 6 These results will allow us to know what to expect with the NB prediction, when dealing with new and unknown patient’s information. Comparing the results with the training set, we find that most of the test metrics are below the confidence interval (mean ± standard deviation), although some are between or above. However, these are slight deviations that should not compromise our analysis. Another interesting fact, for the AUC outcomes, is that the best performing values occur after using bootstrapping and FS, which is in agreement with our training conclusions. These models can be very useful in clinical practice, especially when using the NB classifier, which can be robust enough to ignore serious deficiencies in its underlying naive probability model (Rish, 2001). Table 6. Results in percentage obtained from the test set using the NB classifier. OD is original data; FS is after applying feature selection; NB is Naive Bayes. NB Window (Years)

Bootstrapping No

0 Yes No 1 Yes No 2 Yes No 3 Yes No 4 Yes

Data

AUC

Sensitivity

Specificity

OD

50.09

28.58

93.03

FS

57.94

0.0

100.0

OD

65.41

42.86

70.35

FS

53.49

0.0

94.77

OD

47.11

20.0

89.35

FS

68.26

0.0

100.0

OD

62.99

80.0

51.48

FS

65.98

0.0

94.68

OD

54.55

23.08

88.56

FS

67.75

7.7

98.8

OD

69.79

84.62

48.2

FS

60.48

46.16

75.91

OD

55.29

21.43

87.88

FS

68.84

21.43

96.37

OD

68.66

71.43

53.34

FS

68.06

42.86

80.61

OD

56.41

28.58

89.7

FS

73.12

21.43

96.97

OD

65.55

78.58

46.07

FS

71.74

71.43

64.85

207

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

3.3. Comparison With Framingham The Framingham Heart Study for CHD is described in detail in (D’Agostino, 2000). We applied the Weibull model on the test set in order to obtain a probability estimate for a CHD risk. The features used for this model are described in II-D and were not used on our original dataset, with exception to age and hypertensive medication. These features were obtained from the patient’s clinical file according to their ID and exam date performed. Since some features were not performed on the same day of the Holter exam, we obtained the nearest exam without exceeding a 6 months interval between the Holter exam and the parameters exam. Afterwards we applied our predictive model on the test set and estimated the probability to have a CHD. Regarding features 3) smoking status, 7) menopause and 8) alcohol consumption, described on II-D, these were not available on the patient’s clinical file. Our solution was to obtain this information by contacting each patient that belongs to the test set. For those that we could not reach (37% of the test set) we classified them as missing values. We tested for time windows of 3 and 4 years, however, only a window of 4 years is shown - Figure 2. Comparing the probabilities for each test patient by using the Framingham tool and our predictive model, we found that our classification system identified correctly T2D that will manifest a CHD (red cluster identified in Figure 2) while the Framingham underestimated the results for this population. The probability values for the Framingham do not show any relation with our outcomes or any trend with patients that manifests CHD. Although we present a solution with a higher number of features (that is obtained from the Holter dataset) than the Framingham, our results present a higher precision on the Figure 2. Comparison between Framingham risk tool with our predictive model: Naive Bayes, for a prognosis of 4 years with bootstrapping and FS on the training set. Probability results in percentage. Red dots are T2D patients with a CHD and blue dots are T2D patients without CHD.

208

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

prognostic of the CHD. Moreover, Framingham studies in European population have already been tested and the main conclusion is that it should be used with caution and specific populations risk functions should be implemented (Menotti, 2000) (Empana, 2003).

4. CONCLUSION In this paper we propose a new approach for CHD prognostic prediction on T2D patients, given a Holter dataset. FS was applied given the high number of available features. Bootstrapping was used to provide a more balanced training data. We applied 5x10-fold CV on the training set for different classifiers and selected the classifier that presented the best metrics: AUC, sensitivity and specificity. Following, the test set was applied on the best model - the NB classifier. We achieved an AUC performance of 68,06%, 74,33% for a 3 and 4-years risk prognosis respectively using the data comprising the years from 2006 to 2014 to predict diabetic patients that will evolve to CHD. A drawback of this study is the low number of patients that will evolve to CHD; therefore we used the bootstrapping technique and threshold selector. Also, it is important to mention that supplementary exams can be performed (e.g. echocardiography, chest X-Ray, blood tests) in order to confirm that the patient is actually in risk of CHD. As future work we aim to include a temporal analysis, meaning we want to add new features to the classification that will represent their evolution over time, and could therefore improve our predictive model. This is a data enrichment which is used to investigate possible improvements on classification. We also want to test other machine learning packages such as Theano - it will allow to attain speeds rivalling hand-crafted C implementations for problems involving large amounts of data. We will also compare our predictive model with other existing tools for CHD as mentioned in II-D; however this will only be possible when we reach enough longitudinal data. We will classify new patients with our predictive model and monitor their evolution over the years to confirm our preliminary prognosis. Finally, we also believe that our prognostic methodology could later be adapted to any Holter software as an additional plugin in order to provide an automatic prognostic to the clinician. The following work describes an example of a software plugin inclusion (Pimentel, 2015).

ACKNOWLEDGMENT We thank APDP organization for providing the Holter dataset of T2D patients. Specifically, we would like to thank Frederico Palma and Magda Rosado for their technical support.

CONFLICTS OF INTEREST Pimentel, R. T. Ribeiro, I. Almeida, P. Matos, J. Raposo and H. Gamboa declare that they have no conflict of interest.

209

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

HUMAN STUDIES All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). Informed consent was obtained from all patients for being included in the study.

REFERENCES Aha, D. W., Kibler, D., & Albert, M. K. (1991). Instance-based learning algorithms. Machine Learning, 6(1), 37–66. doi:10.1007/BF00153759 Assign Score - Prioritising Prevention of Cardiovascular Disease. (n.d.). Retrieved March 2015 from http://assign-score.com/ Breiman, L. (2001). Random forests. Machine Learning, 45(1), 5–32. doi:10.1023/A:1010933404324 Burghard, C. (2012). Big Data and Analytics Key to Accountable Care Success. I. H. Insights. Chawla, N. V., Bowyer, K. W., Hall, L. O., & Kegelmeyer, W. P. (2011). SMOTE: Synthetic minority over-sampling technique. Journal of Artificial Intelligence Research, 16, 321–357. Cook, N. R. (2008). Statistical evaluation of prognostic versus diagnostic models: Beyond the ROC curve. Clinical Chemistry, 54(1), 17–23. doi:10.1373/clinchem.2007.096529 PMID:18024533 DAgostino, R. B., Russell, M. W., Huse, D. M., Ellison, R. C., Silbershatz, H., Wilson, P. W., & Hartz, S. C. (2000). Primary and subsequent coronary risk appraisal: New results from the Framingham study. American Heart Journal, 139(2), 272–281. doi:10.1016/S0002-8703(00)90236-9 PMID:10650300 Demšar, J. (2006). Statistical comparisons of classifiers over multiple data sets. Journal of Machine Learning Research, 7(Jan), 1–30. Empana, J. P., Ducimetiere, P., Arveiler, D., Ferrieres, J., Evans, A., Ruidavets, J. B., & ... . (2003). Are the Framingham and PROCAM coronary heart disease risk functions applicable to different European populations? European Heart Journal, 24(21), 1903–1911. doi:10.1016/j.ehj.2003.09.002 PMID:14585248 Fawcett, T. (2006). An introduction to ROC analysis. Pattern Recognition Letters, 27(8), 861–874. doi:10.1016/j.patrec.2005.10.010 Freund, Y., & Mason, L. (1999, June). The alternating decision tree learning algorithm. In ICML (Vol. 99, pp. 124-133). Academic Press. Gardete‐Correia, L., Boavida, J. M., Raposo, J. F., Mesquita, A. C., Fona, C., Carvalho, R., & Massano‐ Cardoso, S. (2010). First diabetes prevalence study in Portugal: PREVADIAB study. Diabetic Medicine, 27(8), 879–881. doi:10.1111/j.1464-5491.2010.03017.x PMID:20653744 Gill, T. M. (2012). The central role of prognosis in clinical decision making. Journal of the American Medical Association, 307(2), 199–200. doi:10.1001/jama.2011.1992 PMID:22235093

210

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

Grzymala-Busse, J. W., Stefanowski, J., & Wilk, S. (2005). A comparison of two approaches to data mining from imbalanced data. Journal of Intelligent Manufacturing, 16(6), 565–573. doi:10.100710845005-4362-2 Hall, M., Frank, E., Holmes, G., Pfahringer, B., Reutemann, P., & Witten, I. H. (2009). The WEKA data mining software: an update. ACM SIGKDD Explorations Newsletter, 11(1), 10-18. Heartscore. (n.d.). Retrieved March 2015 from http://www.heartscore.org/Pages/welcome.aspx INFARMED National Authority of Medicines and Health Products. (n.d.). Retrieved March 2015 from http://www.infarmed.pt/portal/page/portal/INFARMED John, G. H., & Langley, P. (1995, August). Estimating continuous distributions in Bayesian classifiers. In Proceedings of the Eleventh conference on Uncertainty in artificial intelligence (pp. 338-345). Morgan Kaufmann Publishers Inc. Jovanov, E., Gelabert, P., Adhami, R., Wheelock, B., & Adams, R. (1999, August). Real time Holter monitoring of biomedical signals. In DSP Technology and Education conference DSPS (Vol. 99, pp. 4-6). Academic Press. Kohavi, R. (1995, August). A study of cross-validation and bootstrap for accuracy estimation and model selection. In IJCAI (Vol. 14, No. 2, pp. 1137-1145). Academic Press. Kohavi, R., & John, G. H. (1997). Wrappers for feature subset selection. Artificial Intelligence, 97(1), 273–324. doi:10.1016/S0004-3702(97)00043-X Lan, G.-C., Lee, C.-H., Lee, Y.-Y., Tseng, V., Chin, C.-Y., Day, M.-L., ... Wu, J.-S. (2012 November) Disease risk prediction by mining personalized health trend patterns: A case study on diabetes. In 2012 Conference on Technologies and Applications of Artificial Intelligence (pp. 27-32). IEEE. 10.1109/ TAAI.2012.53 Lee, B. J., & Kim, J. Y. (2016). Identification of Type 2 Diabetes Risk Factors Using Phenotypes Consisting of Anthropometry and Triglycerides based on Machine Learning. IEEE Journal of Biomedical and Health Informatics, 20(1), 39-46. Levin, R. I., Cohen, D., Frisbie, W., Selwyn, A. P., Barry, J., Deanfield, J. E., ... Campbell, D. Q. (1986). Potential for real-time processing of the continuously monitored electrocardiogram in the detection, quantitation, and intervention of silent myocardial ischemia. Cardiology Clinics, 4(4), 735–745. PMID:3096569 Menotti, A., Puddu, P. E., & Lanti, M. (2000). Comparison of the Framingham risk function-based coronary chart with risk function from an Italian population study. European Heart Journal, 21(5), 365–370. doi:10.1053/euhj.1999.1864 PMID:10666350 Morrish, N. J., Wang, S. L., Stevens, L. K., Fuller, J. H., & Keen, H. (2001). Mortality and causes of death in the WHO Multinational Study of Vascular Disease in Diabetes. Diabetologia, 44(2), S14–S21. doi:10.1007/PL00002934 PMID:11587045 Orphanou, K., Stassopoulou, A., & Keravnou, E. (2016). DBN-Extended: A Dynamic Bayesian Network Model Extended With Temporal Abstractions for Coronary Heart Disease Prognosis. IEEE Journal of Biomedical and Health Informatics, 20(3), 944-952.

211

 Coronary Heart Disease Prognosis Using Machine-Learning Techniques

Pimentel, A., Gomes, R., Olstad, B. H., & Gamboa, H. (2015). A New Tool for the Automatic Detection of Muscular Voluntary Contractions in the Analysis of Electromyographic Signals. Interacting with Computers, 27(5), 492–499. doi:10.1093/iwc/iwv008 Platt, J. (1998). Sequential minimal optimization: A fast algorithm for training support vector machines. Academic Press. QRISK - Cardiovascular Disease Risk Calculator. (n.d.). Retrieved March 2015 from http://www.qrisk.org/ Raghupathi, W. (2016). Data Mining in Healthcare. Healthcare Informatics: Improving Efficiency Through Technology, Analytics, and Management, 353. Rish, I. (2001, August). An empirical study of the naive Bayes classifier. In IJCAI 2001 Workshop on Empirical Methods in Artificial Intelligence (Vol. 3, No. 22, pp. 41-46). IBM . Shaw, J. E., Sicree, R. A., & Zimmet, P. Z. (2010). Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Research and Clinical Practice, 87(1), 4–14. doi:10.1016/j.diabres.2009.10.007 PMID:19896746 WHO. (n.d.). Retrieved January 2015 from http://www.who.int/en/ Witten, I. H., Frank, E., & Hall, M. A. (2011). Data Mining: Practical Machine Learning Tools and Techniques. Elsevier.

This research was previously published in Ubiquitous Machine Learning and Its Applications edited by Pradeep Kumar and Arvind Tiwari, pages 89-112, copyright year 2017 by Information Science Reference (an imprint of IGI Global).

212

Coronary Heart Disease Prognosis Using Machine-Learning Techniques

APPENDIX A: FEATURE DESCRIPTIONS Tables 7 and 8 presents all features used for classification. Table 7 shows the features provided by the Holter, and Table 8 the created features for medication. Table 7. Feature descriptions without medication Feature

Description

Feature

PATIENT_ID

patient id

24h QT Lead C QTa (ms)

EXAM_DATE

exam date

24h QT Lead C QTe (ms)

Birth date

birth date

24h QT Lead C QTac (ms)

Age

Age

24h QT Lead C Slope (mV/s)

Gender

Gender

24h QT Lead C Total QRS

Pacemaker

pacemaker - yes or no

24h QT Lead C Nb. QRS

Number of day

nr of days that performed exam

24h QT Lead C Amplitude (V)

Number of Day Recorded

Description

24h QT Lead C QTec (ms)

Average

heart rate average in bpm

24h QT Lead C SD RR (ms)

Max. H.R (bpm)

max heart rate in bpm

24h QT Lead C Mean RR (ms)

Min. H.R (bpm)

min heart rate in bpm

24h QT Lead M Total QRS

Mean day H.R. (bpm)

mean heart rate during day in bpm

24h QT Lead M Nb. QRS

Mean Night H.R. (bpm)

mean heart rate during night in bpm

24h QT Lead M SD RR (ms)

Max. RR (ms)

max RR in ms

24h QT Lead M Mean RR (ms)

Min. RR (ms)

min RR in ms

LF/HF

ratio between low frequency high frequency for 24 hours

Total no.of QRS

total nr of QRS complexes

EV

ventricular extra-systole

BRADYCARDIA

nr of bradycardias

TV

ventricular tachycardia

PAUSE

nr of pauses

ESV

supraventricular extra-systole

MISSED BEATS

nr of missed beats

TSV

supraventricular tachycardia

VPB

nr of isolated ventricular ectopic beats events

NORMAL

V_COUPLET

nr of couplet ventricular ectopic beats events

ritmo_circadiano

circadian rhythm (normal or abolished)

V_RUN

nr of runs ventricular ectopic beats events

24h HR (bpm)

heart rate for 24 hours in bpm

V. Bigeminy

nr of bigeminy ventricular events

PNN50

percentage of the normal heartbeat intervals (NN) > than 50 ms

V.Trigeminy

nr of trigeminy ventricular events

24h PNN30 (perc)

percentage of the normal heartbeat intervals (NN) > than 30 ms

V_TACHYCARDIA

nr of tachycardias ventricular events

RMSSD

square root of the mean of the squares of the successive differences between adjacent NNs during 24h

continued on following page

213

Coronary Heart Disease Prognosis Using Machine-Learning Techniques

Table 7. Continued Feature

Description

Feature

Description

SVPB

nr of isolated supraventricular ectopic beats events

24h VarIndex (perc)

percentage of delta of RR. Delta RR: RR(i)-R(i-1) for 24 hours

SV_COUPLET

nr of couplet supraventricular ectopic beats events

24h ASDNN/5mn (ms)

average of all 5-min standard deviation of all NN intervals for 24h

SV_RUN

nr of runs supraventricular ectopic beats events

24h SDANN/5mn (ms)

standard deviation of the average NN intervals over 5 min interval for 24h

SVBg

nr supraventricular events bigeminy

SD/SDNN

ratio standard deviation with standard deviation of all NN intervals

SVTg

nr supraventricular events trigeminy

24h Total Power (ms)

total power of FFT between 0Hz and 2Hz in ms for 24h

SVT

nr supraventricular events tachycardia

24h VLF (ms)

very low frequency in ms for 24h

RR INSTABILITY

nr of supraventricular events for RR instability

LF

low frequency in ms

Acceleration

HF

high frequency in ms

Deceleration

Day: HR (bpm)

heart rate in bpm during day

EPISODES OF ST SEGMENT DEVIATION

Day: PNN50 (perc)

percentage of NN > than 50ms during day

Minimum pause duration (ms)

minmum value to count for a pause in ms

Day: PNN30 (perc)

percentage of NN > than 30ms during day

Supraventricular prematurity < (perc)

limit value to count a supraventricular prematurity in percentage

Day: RMSSD (ms)

square root of the mean of the squares of the successive differences between adjacent NNs during the day

Bradycardia < (bpm)

limit value to count a bradycardia in bpm

Day: VarIndex (perc)

percentage of delta of RR. Delta RR: RR(i)-R(i-1) during day

Ventricular tachycardia > (bpm)

limit value to count a ventricular tachycardia in bpm

Day: ASDNN/5mn (ms)

average of all 5-min standard deviation of all NN intervals during day

Day: SDANN/5mn (ms)

standard deviation of the average NN intervals over 5 min interval during day

Deceleration (perc) Spontaneous Rhythm avP

spontaneous rythm in percentage pacemaker rhythm in percentage

Day: SD (ms)

standard deviation during day

Day: Total Power (ms)

total power of FFT between 0Hz and 2Hz in ms during day

aP

Day: VLF (ms)

very low frequency in ms during day

vP

Day: LF (ms)

low frequency in ms during day

Fp

Day: HF (ms)

high frequency in ms during day

Define VLF

limit for very low frequency in Hz

Night: HR (bpm)

heart rate in bpm during night

Define LF

limit for low frequency in Hz

Night: PNN50 (perc)

percentage of NN > than 50ms during night

Define HF

limit for high frequency in Hz

Night: PNN30 (perc)

percentage of NN > than 30ms during night

Night: RMSSD (ms)

square root of the mean of the squares of the successive differences between adjacent NNs during the night

24h QT Lead A QTa (ms)

continued on following page 214

Coronary Heart Disease Prognosis Using Machine-Learning Techniques

Table 7. Continued Feature

Description

Feature

Description

24h QT Lead A QTe (ms)

Night: VarIndex (perc)

percentage of delta of RR. Delta RR: RR(i)-R(i-1) during night

24h QT Lead A QTac (ms)

Night: ASDNN/5mn (ms)

average of all 5-min standard deviation of all NN intervals during night

24h QT Lead A Slope (mV/s)

Night: SDANN/5mn (ms)

standard deviation of the average NN intervals over 5 min interval during night

24h QT Lead A Total QRS

Night: SD (ms)

standard deviation in ms

24h QT Lead A Nb. QRS

Night: Total Power (ms)

total power of FFT between 0Hz and 2Hz in ms during night

24h QT Lead A Amplitude (V)

Night: VLF (ms)

very low frequency in ms during night

24h QT Lead A QTec (ms)

Night: LF (ms)

low frequency in ms during night

24h QT Lead A SD RR (ms)

Night: HF (ms)

high frequency in ms during night

24h QT Lead A Mean RR (ms)

MedHyper

medication for hypertension - yes or no

24h QT Lead B QTa (ms)

Statins

medication that are in statins groups - yes or no

24h QT Lead B QTe (ms)

Antiagregant

medication that is antiplatelet agents - yes or no

24h QT Lead B QTac (ms)

Betablockers

medication that is betablockers - yes or no

24h QT Lead B Slope (mV/s)

Antiarrythmic

medication that is antiarrythmic -yes or no

24h QT Lead B Total QRS

freq6070

heart rate average between 60 and 70 -yes or no

24h QT Lead B Nb. QRS

freq7080

heart rate average between 70 and 80 - yes or no

24h QT Lead B Amplitude (V)

freq8090

heart rate average between 80 and 90 - yes or no

24h QT Lead B QTec (ms)

freq90100

heart rate average between 90 and 100 -yes or no

24h QT Lead B SD RR (ms)

Evolution

evolution to CHD - yes or no

24h QT Lead B Mean RR (ms)

215

Coronary Heart Disease Prognosis Using Machine-Learning Techniques

Table 8. Medication used according to their active principle level Livetan

Glucovance

Crestor

Magnesium

Diovan

Supralip

Trajenta

Aas

Cloretotrospio

Blopress

Niaspan

Semi-Daonil

Singulair

Atacand

Pariet

Actrapid

Cozaar

Elugel

Lantus

Loftyl

Rivotril

Pantoprazol

Cartia

Pentoxifilina

Indapamida

Amizal

Pritor

Silodyx

Sertralina

Dilamax

Dancor

Irbesartan

Salazopirina

Ramipril

Januvia

Captopril

Glucobay

Amoxicilina

Adalat

Thyrax

Lyrica

Furosemida

Valdoxan

Gradumet

Mixtard

Lortaan

Lercanidipina

Diazepam

Rasilez

Folicil

Pulmicort

Duagen

Lopresor

Diclofenac

Lescol

Zolnor

Lisinopril

Seroxat

Hyperium

Varfine

Cervoxan

Diamicron

Tromalyt

Euritox

Micardis

Proaxen

Tecnosal

Nexium

Nebivolol

Glucophage

Humalog

Simvastatina

Alprazolam

Xanax

Zolpidem

Aspegic

Aldactone

Praxilene

Norvasc

Conversyl

Pradaxa

Ever-Fit-Cardioantioxidante

Ticlopidina

Medipax

Zyloric

Isoptin

Lanoxin

Socian

Canef

Metformina

Zestoretic

Olsar

Preterax

Atenolol

Triatec

Adalgur

Vitalux

Maxilase

Concor

Inegy

Venex

Diltiazem

Bromazepam

Preslow

Fluoxetina

Monoket

Tricef

Daflon

Clopidogrel

Co-Diovan

Amlodipina

Icandra

Glimepirida

Doxi-Om

Carvedilol

Atorvastatina

Daonil

Morfex

Filotempo

Hytacand

Catalip

Triapin

Varimine

Beta-Histina

Cipralex

Indur

Ezetrol

Cyclo

Persantin

Venlafaxina

Viartril

Letter

Omeprazol

Inderal

Visacor

Amiodarona

Brufen

Lendormin

Salofalk

Pravastatina

Ranitidina

Olmetec

Zofenopril

Sintron

Zurim

Alfuzosina

Enalapril

Tecnolip

Vipocem

Nitroglicerina

Avandamet

Tansulosina

Sinemet

Gabapentina

Permixon

Actonel

Fosavance

Janumet

Ferro

Difrarel

Losartan

Combodart

Zanitek

Aprovel

Co-Aprovel

216

Coronary Heart Disease Prognosis Using Machine-Learning Techniques

APPENDIX B: CLASSIFIERS PARAMETERS OPTIMIZATION Table 9 shows the best parameters obtained after applying CV on each classifier for different values. We have provided this table in order to facilitate its reproducibility. Table 9. CV parameters optimization. RF presents the best number of trees after testing values from 10 to 1000. SVM presents the best complexity parameter after testing values from 0.1 to 10. ADT presents the best number of boosting iterations after testing values from 5 to 50. KNN presents the best number of nearest neighbours after testing values from 1 to 10. Window (Years) 0 1 2 3 4

Data

RF

SVM

ADT

KNN

OD

10

0.1

5

2

FS

10

0.1

5

1

OD

10

0.1

10

4

FS

10

2.3

25

1

OD

10

0.1

10

2

FS

230

1.2

5

9

OD

10

0.1

5

2

FS

890

0.1

5

4

OD

10

0.1

20

2

FS

10

0.1

10

7

217

218

Chapter 12

Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions in an Aging Population Enoch Chan University of New South Wales, Australia Sai Wang Seto Western Sydney University, Australia Tsoi Ming Au Yeung Hong Kong Community College, Hong Kong Gabriel Hoi Huen Chan Hong Kong Community College, Hong Kong

ABSTRACT Chronic conditions are important problems for an aging society. They impede on healthy aging and increases the cost of living due to increased medical cost. The most prevalent chronic conditions faced by the elderly population are hypertension, high cholesterol and diabetes mellitus. They increase the risk of developing atherosclerosis, a chronic condition which causes heart attack and stroke. This chapter provides a review on existing therapeutics for the treatment of cardiovascular disease, and briefly discusses their side effects. This chapter also provides a brief introduction to Traditional Chinese Medicine (TCM), and its development in ancient China. This will be followed by a discussion on the recent research on the use of Chinese herbal medicine (CHM) in the treatment of cardiovascular diseases, and the potentials and challenges of incorporating CHM in mainstream healthcare system.

DOI: 10.4018/978-1-5225-7122-3.ch012

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

INTRODUCTION Chronic conditions are the major obstacles to healthy aging. They impact on the quality of life and increase the cost of living. The top three most prevalent chronic conditions in the elderly population are hypertension, high cholesterol and diabetes mellitus (Census and Statistics Department Hong Kong SAR, 2014). These chronic conditions are the main contributing factors to atherosclerosis, which can manifest as ischemic heart disease and stroke, the two most common causes of death in the world (World Health Organization, 2014). Chinese Herbal Medicine (CHM) has been used for thousands of years in China. In recent years, there is greater recognition of CHM due to advances in pre-clinical and clinical research leading to mounting evidence of its efficacy. This chapter will first highlight the important public health problems faced by an aging and westernizing Chinese community – ischemic heart disease and stroke; and an outline of conventional therapeutics being used to manage ischemic heart disease and stroke. Then the pitfalls of existing therapeutics will be discussed, followed by a brief introduction to CHM and generic examples of the use of CHM in health maintenance; and a review on pre-clinical and clinical studies on using CHM or integrative Western and Chinese Medicine specifically in managing ischemic heart disease and stroke. The readers will gain an appreciation of how CHM being combined with modern Western medicine or on its own can be used to manage ischemic heart disease and stroke, and ultimately promoting healthy aging. It also hopes to encourage medical professionals and policymakers to consider how to better engage Chinese medicine practitioners when devising treatment regime for their patients where appropriate to bring about the best outcome for patients.

BACKGROUND There has been an increasing life expectancy in the populations of most developed countries in the last decade. From 2004 to 2014, life expectancy for both male and female increased by 2 years in most countries including Hong Kong (Food and Health Bureau, 2016). Moreover, in Hong Kong approximately 15% of the population are aged 65 years or older at the end of 2015 (Census and Statistics Department Hong Kong SAR, 2016). It is expected to double and reach approximately 30% in the next 20 years (Census and Statistics Department Hong Kong SAR, 2015), and by then the median age will shift to 50. The increase in life expectancy and the aging of population over the past decades have led to a substantial increase in age-related cardiac, arterial and microvascular diseases in developed countries. It is well documented that aging is closely associated with the progressive decline in normal physiological functions and has significant impact on the heart and vascular system. The incidence of ischemic heart disease and stroke increases exponentially with aging. According to the World Health Organization (WHO) (2014), ischemic heart disease and stroke were the top two leading causes of death in 2012, accounting for 7.4 million and 6.7 million of deaths, respectively. In Hong Kong, diseases of heart and cerebrovascular diseases were both listed among the top four causes of death in Hong Kong for elderly people aged 65 and over (Census and Statistics Department Hong Kong SAR, 2014).

219

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

In a recent study in Hong Kong, total direct medical cost for a patient newly diagnosed with stable ischemic heart disease is approximately HK$ 89,700 (US$ 11,500) in the first-year, where the cost can be significantly higher if the patients required surgical procedures for their conditions (Lee et al., 2013). These costs are currently not being covered under the Public healthcare in Hong Kong, and the patients are often required to pay out of pocket. The ongoing cost in managing chronic conditions is also likely to increase, due to an extended lifespan of individuals and inflation. In the coming years, the society will be facing an increase in the proportion of elderly people and the decrease in the number of working population. Moreover, the public healthcare sectors face shortage of doctors and the lack of hospital beds in public hospitals. Therefore, there is a pressing need to develop more effective medications to combat aging-related cardiovascular diseases, as well as effective ways to prevent cardiovascular complications once chronic conditions, such as diabetes and high cholesterol level, are detected. Traditional Chinese Medicine (TCM) has had a very long and rich history in the Chinese community, and is third oldest form of medicine the world has ever known. It originated and developed over thousands of years in ancient China. In the pre-historical time, Shennong, who was the deity of agriculture in Chinese mythology, was said to have used himself as test subject and tried various herbs and tested the medicinal effects. A major milestone in the developmental history of CHM occurred in the Ming dynasty, when Li Sizhen authored the Ben Cao Gang Mu (Compendium of Materia Medica). It provided detailed diagrams for each herb and until today it remains the most comprehensive herbal encyclopedia in the history of Chinese medicine. Throughout history, Chinese herbal medicine provided a solid foundation for the development of other forms of traditional medicines in Asia, including Kampo in Traditional Japanese Medicine and Traditional Korean Medicine. However, being isolated in east Asia throughout its developmental history, the development of TCM in other parts of the world was limited. To date, TCM is considered an alternative medicine in modern world due to the lack of scientific evidence to prove its effectiveness, and the fact that in TCM, physiology and pathophysiology are explained in ways that are radically different from modern medical science. In fact, physiology and pathophysiology are founded on the Chinese theories of Yin and Yang, Wu-Xing (Five Elements), Zang-Fu (Organs) and Qi (Energy). There has been a marked increase in the popularity of CHM in both Western and Asian countries over the past few decades (Hao et al., 2015; Karalliedde & Kappagoda, 2009). It is reported that over 65% of the Australian population have used complementary and alternative medicine, including CHM, to alleviate chronic or recurrent conditions (Team et al., 2011). In addition, herbal medicines have been approved as treatment for cardiovascular diseases in both Germany and Japan (Karalliedde & Kappagoda, 2009). There has also been a growing acceptance of CHM.

MANAGEMENT OF CHRONIC DISEASES IN AGING Chronic Diseases in Aging Population Advanced age is one of the major risk factors of cardiovascular and cerebrovascular diseases as demonstrated by numerous epidemiological studies (Fleg et al., 1995; Lakatta, 2003). As reported by WHO (2014), the number of deaths due to ischemic heart disease in the world for individuals aged 60 or above is approximately 4 times higher than that in individuals of other ages, while the number of deaths due to stroke for individuals aged 60 or above is approximately 5.5 times higher.

220

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Hypertension is a major risk factor for cardiovascular diseases (Špinar, 2012). The risk of stroke in elderly patients increases by more than double when systolic blood pressure is 160 mm Hg or higher, compared to those of less than 140 mm Hg (Cressman & Gifford, 1983). In fact, among hypertensive patients, stroke is a more common complication than heart attack (Kjeldsen, Julius, Hedner, & Hansson, 2001). High cholesterol and triglycerides levels are also major problems faced by elderly people (Census and Statistics Department Hong Kong SAR, 2014). In recent years, Western fast food with high fat content has become much more accessible by most individuals in urban Chinese cities because of accelerated globalization, busier lifestyle and longer working hours. A clinical study indicates that “Westernized” Chinese adults have higher LDL-cholesterol compared to their rural counterparts (Woo et al., 1999). In addition, the lack of exercise also correlates with higher LDL-cholesterol level (Gordon et al., 2008; Prabhakaran, Dowling, Branch, Swain, & Leutholtz, 1999). Increased cholesterol and triglycerides levels are important risk factors for cardiovascular disease (Yarnell et al., 2001). Diabetes mellitus is another major problems faced by elderly people (Census and Statistics Department Hong Kong SAR, 2014). It is a chronic condition in which the body cannot regulate glucose in the blood, resulting in high glucose levels. In 2015, approximately 9.3% of adults in Asia Pacific region, aged between 20-79, had diabetes. In the same year, 1.9 million people in this region died due to diabetes, and 65% of this group were aged above 60. It was estimated that 12% of global health expenditure was due to diabetes (International Diabetes Federation, 2015). It is expected that in 2040, the prevalence of diabetes in Asia Pacific region will increase to 11.9%. Diabetes increases the risk of ischemic heart disease and stroke by 2 to 4-folds (Beckman, Creager, & Libby, 2002). Underlying ischemic heart disease and stroke is a pathological condition called “atherosclerosis” – the buildup of fatty material in blood vessels (Kumar, Abbas, & Aster, 2013). Atherosclerosis can start in early adolescence without presenting any signs and symptoms (McGill et al., 2000). However, with advancing age, the symptoms may appear. The progression of atherosclerosis in blood vessels narrows the passage for blood flow. Atherosclerosis usually gives rise to no significant symptoms unless it becomes vulnerable and ruptures. The rupture of an atherosclerotic lesion leads to clotting of blood, and may result in the complete obstruction of blood flow. In the worse scenario, the obstruction may occur in the important blood vessels that supply blood to the heart or the brain, and this would cause a heart attack or a stroke (Kumar, et al., 2013). Moreover, the heart and blood vessel structure and function alter progressively as part of the normal aging process even without the presence of atherosclerosis or hypertension, the major contributing factors of cardiovascular dysfunction (Susic, & Frohlich, 2008). In the heart, a series of notable changes, such as decrease in the elasticity of the heart wall, thickening of the heart valves, impaired intracellular calcium handling and cardiac muscle cell apoptosis, are commonly observed, hence affecting the ability of the heart to pump blood efficiently (Shah et al., 2012; Stern, Behar, & Gottlieb, 2003). Similarly, blood vessels also undergo significant changes, including stiffening, wall thickening and endothelial dysfunction. Although these cardiovascular changes are deemed to be part of the normal aging process, when combined with other risk factors, such as type 2 diabetes, hypertension, dyslipidemia, obesity and smoking, which are commonly present in the aged population, can lead to cardiovascular diseases. Even though aging is an inevitable and intractable process, it is thought that aging can be slowed down by various interventions including dietary, nutraceutical and pharmacological agents that may delay or prevent a range of age-associated diseases.

221

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Conventional Management of Cardiovascular Diseases in Elderly While pharmacological therapy remains the most commonly used interventions for elderly patients with cardiovascular conditions, the use of cardiovascular medication is more challenging among older patients. Age-related changes in renal functions, hepatic blood flow, muscle mass and end-organ responsiveness can affect the efficacy of cardiovascular drugs. For example, older patients are more likely to develop orthostatic hypotension with the use of nitrates and α-adrenergic blockers due to reduced cardiovascular responses to catecholamine and the carotid sinus baroreceptor sensitivity (Fleg, 2008). Indeed, it is not uncommon that older patients present with multiple disease states concurrently. Moreover, polypharmacy, the use of four or more medications, is another major concern when prescribing cardiovascular medicine to older patients. Studies have shown more than 50% of older patients receive five or more prescription medicines for the treatment of hypertension, heart failure and diabetes (Fleg, Aronow, & Frishman, 2011; Jyrkkä, Vartiainen, Hartikainen, Sulkava, & Enlund, 2006). The higher number of medications used in older patients has considerably increased the possibility of both drug-drug interaction as well as drugdisease interaction, highlighting the importance of knowledge in age-related physiological changes and the need of a holistic approach in the use of cardiovascular drugs in elderly. The following section is an overview of drugs commonly used in elderly for cardiovascular diseases.

Blood Pressure-Lowering Drugs The angiotensin converting enzyme inhibitor (ACEI) blocks the generation of the powerful vasoconstrictor angiotensin II (Ang II) both systemically and locally, reducing blood pressure without reflex stimulation of heart rate. It is one of the most frequently administered drugs in elderly, given the fact that it can influences three diseases (coronary artery disease, hypertension and diabetes) simultaneously. A meta-analysis of 109 studies has shown that ACEI are more effective than other antihypertensive agents in reducing left ventricle (LV) mass (Dahlöf, Pennert, & Hansson, 1992). Numerous clinical studies have demonstrated that ACEI reduces risk of cardiovascular events to a similar extent as other antihypertensive agents (Lennart Hansson et al., 1999). Another study showed that ACEI is more effective than diuretics in reducing cardiovascular events in elderly (Wing et al., 2003). Although ACEI has been recommended as the standard therapy for most elderly patient with significant LV systolic dysfunction with or without chronic heart failure (CHF), it is important to be aware of the possible deterioration of renal function, palpitations and cardiac rhythm disorder and hypotension when initiation ACEI treatment in elderly patients (Pfeffer et al., 1992; Yusuf et al., 1992). Hyperkalemia can also occur in elderly patients with renal insufficiency. Therefore, treatment with ACEI should be started at low dose after correction and titrated gradually to avoid overdiuresis and hypotension. Angiotensin receptor I blocker (ARB) inhibits the effects of Ang II by blocking of the angiotensin receptor, thus exhibit very similar and comparable effects to ACEI in hypertension, diabetes, and CHF (Grossman, Messerli, & Neutel, 2000; Okereke & Messerli, 2001). It is noteworthy that ARB has fewer side-effects, more tolerable with minimal first-dose hypotension when comparing to ACEI (Elliott, 2000; Tadevosyan, MacLaughlin, & Karamyan, 2011). Hence, they have been considered as safer and a more superior option for elderly patient with type 2 diabetes mellitus, hypertension and CHF (Brenner et al., 2001; Lindholm et al., 2002).

222

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

β-blockers have been used to treat hypertension for decades and have been shown to be an effective anti-anginal agents in both young and elderly patients (Frishman, Chiu, Landzberg, & Weiss, 1998; Sica, 1999). In controlled clinical trials, β-blockers have been shown to reduce cardiovascular morbidity and mortality, particularly older hypertensive patients with myocardial infraction, angina pectoris, arrhythmias or hypertrophic cardiomyopathy (Chobanian et al., 2003; Sica, 1999; Teo, Yusuf, & Furberg, 1993). It is also worth to point out that despite some studies showing no or limited beneficial effects of β-blockers monotherapy in reducing the incidence of stroke, coronary events and total cardiovascular events, β-blockers could have a role in combination therapy (Dahlöf et al., 1991; L Hansson, 1990). When co-administrated with diuretics and ACEI, β-blockers significantly reduced mortality in older patients with CHF (Aronow, Ahn, & Kronzon, 1997, 2001; Flather et al., 2005). In some elderly patient, even a very small dose of β-blockers can induce disordered of atrioventricular conduction and severe bradycardia (Kubesova, Weber, Meluzinova, Bielakova, & Matejovsky, 2013). Moreover, the β-blockers should be used carefully in elderly CHF patient with chronic obstructive pulmonary disease (COPD) to avoid further deterioration of myocardium contractility and manifest heart failure. Finally, drug interaction should be considered when prescribing β-blockers to elderly patient (Frishman, et al., 1998). Diuretics have been the mainstay for blood pressure management in elderly. They are commonly used due to their low cost and are generally well-tolerated. Serum electrolytes must be closely monitored when treating elderly with diuretics to prevent hypokalemia and hypomagnesemia which can lead to ventricular arrhythmias and/or digitalis toxicity (Franse et al., 2000). Also, hyponatremia is occurring more frequently in older patients under diuretics therapy and has been associated with fatigue, cognitive impairment, gait, falls and even increased mortality in elderly patients (Hoorn & Zietse, 2011; Kengne, Andres, Sattar, Melot, & Decaux, 2008; Liamis, Filippatos, Liontos, & Elisaf, 2016). Age-related impairment in renal function may reduce the efficacy of conventional doses of diuretics in elder patients. In several randomized controlled trials (RCTs), diuretics have been shown to reduce cardiovascular events when combined with ACEI or β-blockers in elderly patients (Beckett et al., 2008; Chobanian, et al., 2003). In addition, recent meta-analysis has demonstrated that diuretic antihypertensive drugs are associated with reduction in dementia risk in elderly (Tully, Hanon, Cosh, & Tzourio, 2016).

Lipid-Lowering Drugs Dyslipidemia is a major risk factor for cardiovascular diseases in aging population. Total cholesterol and LDL levels are strongly correlated with fatal coronary heart disease across all age groups, including individuals aged over 65. The statins are the most popularly used lipid lowering drugs due to its effectiveness and good tolerance. Its effectiveness in lowering serum LDL as well as reduction in major coronary events and death has been demonstrated (Scandinavian Simvastatin Survival Study Group, 1994). Later study has shown that the effects in reducing both all-cause mortality in individual aged between 65-70 is two times greater than individuals younger than 65 (Miettinen et al., 1997). Similarly, a RCT study of 8,804 patients has demonstrated the reduction of LDL level by 34% in individual aged between 72-80 years, and the reduction of coronary heart disease death and nonfatal myocardial infraction (Shepherd, 2002). Many other studies have also reported similar results, highlighting the benefits of statins in reducing cardiovascular event in the elderly (Heart Protection Study Collaborative Group, 2002; Lewis et al., 1998). Although statins are generally considered well-tolerated and safe, side effects, including headache, insomnia, myalgia, rhabdomyolysis and dyspepsia, are more frequently observed in elderly patients. These side effects (Kevelaitiene & Slapikas, 2007) 223

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Anticoagulants Anticoagulants are commonly used to manage various cardiovascular conditions such as nonvalvular atrial fibrillation, venous thromboembolism, ischemic heart disease, stroke and mechanical heart valve. Given the fact that these conditions increase with advancing age, anticoagulants are one of the most frequently prescribed drugs used in the older population. For example, the prevalence of arterial fibrillation (AF) increased from less than 1% in individuals aged 50 and under to 10% in octogenarians. Stroke, caused by embolization of clots from atrium to the brain, is one of the major complications of AF in the older population. AF contributes to 23.5% of stroke in the patients over 80 years of age (Wolf, Abbott, & Kannel, 1991). Numerous clinical trials have demonstrated that anticoagulants prevent stroke in AF (Bajorek, Magin, Hilmer, & Krass, 2014; Ford et al., 2007; Olsson & Halperin, 2005). When administrating anticoagulant to elderly patients, it is important to be aware of drug-drug interactions that can increase the risk of bleeding, because older patients tends to receive multiple medications. In addition, the anticoagulant response to certain anticoagulation agents such as warfarin increases with age.

THE POTENTIAL OF USING CHINESE HERBAL MEDICINE FOR HEALTH MAINTENANCE IN THE ELDERLY In Hong Kong, from 2008 to 2012, there has been a 6-fold increase in the total number of chronic disease patients who reported using Chinese medicine regularly, both exclusively and together with Western medicine. To the public, CHM is considered to have milder pharmacological effects than Western medicine with fewer the side effects. For example, when facing communicable diseases such as flu or common cold, Western medicine is usually seen as the preferred first-line treatment. Also, CHM is sometimes considered as an “alternative” therapy when Western medicine fails (Lam, 2001). Interestingly, CHM has the advantages over some abstract complaints of mild symptoms that are not regarded as problematic by Western medicine practitioners. For example, elderly people may complain about “fungus-like substances” growing on the tongue or bitterness in the mouth. Apart from being poisoned or stimulated by certain kind of chemicals, such symptoms are hardly diagnosed by Western medicine practitioners. However, in TCM, these are very common “symptoms” indicating sub-optimal health, indicating “humidity” in the body and gastrointestinal tract upset. They can be treated by CHM formulae known as “dehumidifying tea” and “tea for relieving stagnancy”. These formulae can be prescribed based on the overall health status of the patients, highlighting the fact that TCM practitioners treat their patients in a holistic and personalized approach, in contrast to Western medicine which manages sickness and diseases symptomatically. Western medicine has been the standard for the treatment of infectious diseases. The discovery by Alexander Fleming has marked a milestone in the development of Western medicine, because antibiotics are selectively working on the disease-causing bacteria (Drago et al., 2016; Gruson et al., 2000). However, the use of antibiotics poses an evolutionary pressure to pathogens, and this can give rise to “super-pathogen” that are resistant to antibiotics (Davies & Davies, 2010). Elderly patients are the group of the main risk with methicillin-resistant Staphylococcus aureus (MRSA) infection (Y. Ge, 2014). On the other hand, mounting experimental evidence shows that Chinese herbal medicine can be effective in treating even infectious diseases. TCM is usually composed of very complicated components and antibiotic resistances is not easily developed towards numerous amounts of active ingredients. For anti-viral 224

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

activities, CHM may be a better candidate for therapy because traditional anti-viral drugs have notorious side effects. Compared to Western medicine, TCM has the advantages of rich resources, low price and less adverse effects (Huang, Su, Feng, Liu, & Song, 2014). Elderly people, especially the Chinese ethnic groups, prefer taking TCM (Kong & Hsieh, 2012). In addition, according to the WHO traditional medicine strategy, the cost to treat neck pain with physiotherapy or care provided by a general practitioner is more expensive and it is believed that many governments recognize the need to develop a cohesive and integrative approach, so that the TCM therapy can be provided in a safe, respectful, cost-efficient and effective manner (World Health Organization, 2014).

Research on the Use of Chinese Herbal Medicines in Cardiovascular Diseases As mentioned previously, most of the drugs used in western medicine have well defined composition, chemical structure, pharmacological properties and mechanisms of actions. Although Western medicines have been shown to reduce cardiovascular mortality effectively, a substantial proportion of elderly still remains at high risk of cardiovascular events. The situation may be due to the fact that the majority of western cardiovascular medicines focus only on the management of the ‘hard’ clinical outcomes rather than the improvement of the quality of life, that might be of a greater concern for the elderly patients. Furthermore, it has been a major issue among the elderly for not adhering to prescription drugs, i.e. poor drug compliance, due to the increased adverse effects arising from polypharmacy, or use of multiple drugs (MacLaughlin et al., 2005). In contrast, CHMs has been used for thousands of years in the management of diseases, maintenance of health and prolongation of life. Chinese medicine practitioners often adopt a holistic approach in treating patients, managing cardiovascular conditions through integrated care; nourishing and strengthening the body functions rather than focusing solely on relieving clinical symptoms. For example, hypertensive patients may receive CHM that “strengthens” heart, liver, spleen, lung or kidney according to TCM theory. Nonetheless, there are a large body of evidence suggesting that many CHMs and their active ingredients possess cardiovascular protective properties with minimal and few adverse reactions (Hong et al., 2009; Liu et al., 2014; Ravera et al., 2016). It comes no surprise that there has been a marked increase in the popularity of CHM in both the Western and Asian countries over the past few decades (Hao, et al., 2015; Karalliedde & Kappagoda, 2009). In Australia, over 65% of the population have used complementary and alternative medicine, including CHM, to alleviate chronic or recurrent conditions (Team, Canaway, & Manderson, 2011). In addition, herbal medicines have been approved to treat cardiovascular diseases in both Germany and Japan (Karalliedde & Kappagoda, 2009). There has also been an increasing trend of acceptance of CHM. Numerous basic and clinical studies have demonstrated the beneficial effects of CHMs on cardiovascular diseases. A recent population-based retrospective study in Taiwan showed there was a 33% decreased risk of stokes among 1,049 type 2 diabetic patients that used CHMs (Lee et al., 2016). In a multi-centre, randomized, double-blind, placebo-controlled trial involving 4,870 Chinese patients with a history of myocardial infractions, xuezhikang, a partially purified extract of red yeast rice significantly decreased cardiovascular and all-cause mortality by 30% and 33% respectively. Moreover, the same study also showed that long term treatment of xuezhikang significantly lowered serum levels of total and LDL cholesterol and prevented the occurrence of coronary events in patients with a history of myocardial infraction (Lu et al., 2008). Many CHMs and their active components, such as Coptis chinensis, Scutel225

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

laria baicalensis, Panax ginseng and Ganoderma lucidum, have been shown to have anti-arrhythmic property (Hao, et al., 2015). In particular, Scutellaria baicalensis has also been shown to protect against myocardial infarction in a rat model (Chan et al., 2011). In a randomized, double blind, placebo-controlled multi-centre trial, a 4-week treatment with shensongyangxin significantly increased the heart rate in patients with atrioventricular block. More importantly, only minimal side effects were observed (0.8%) in the treated group (Liu, et al., 2014). These results highlighted the usefulness of CHMs in normalizing heart rhythm in patients with bradycardia, given the fact that almost all current clinical available western anti-arrhythmic drugs have notable adverse effects (Brignote, Auricchio, & Baron-Esquivias, 2013). It is interesting to note that in a prospective cohort study involving 13,655 diabetic patients, the rate of coronary artery disease admission of diabetic patients received CHMs is not significantly different from those receiving western medicine (Fang et al, 2015), suggesting that CHMs could have similar therapeutic effects as western medicine. A pre-clinical study has demonstrated that Panax notoginseng saponin has more superior vascular protective effects than aspirin via the inhibition of platelet adhesion and apoptosis in both endothelial cells and platelets and downregulates the atherosclerosis-promoting genes (Wang et al., 2016; Chan et al., 2013). In addition, Lingzhi is also shown to decrease blood glucose level in animal model of type 2 diabetes (Seto et al., 2009). However, it is important to point out that, although there are mounting reports indicating the beneficial role of CHMs in cardiovascular managements, some reports have suggested otherwise. For example, Panahi et al. (2011) have failed to show any significant benefit of supplementation with H. persicum extract in patients with minimal coronary artery disease, despite several pharmacological studies have indicated that H. persicum could be important in the prevention of atherosclerosis and the promotion of cardiovascular health due to its anti-oxidative, anti-inflammatory and lipid-modifying properties (Firuzi et al., 2010; Hajhashemi, Sajjadi, & Heshmati, 2009; Panahi, Pishgoo, & Sahebkar, 2015). Moreover, many clinical trials on CHMs suffer from the shortcomings of small sample size, short follow-up period and diverse outcome results.

Incorporation of Chinese Herbal Medicine in the Modern Healthcare System A national survey in China in 2004 reported 71.2% and 18.7% of patients preferred integrative medicine, i.e. TCM combined with Western medicine, and TCM respectively (Chen & Lu, 2006). Integrative medicine has been shown to have effects in alleviating clinical symptoms and in improving the quality of life in cardiovascular patients (Chu, Wang, Yao, & Li, 2010; Zhang et al, 2009). In a clinical study involving 108 unstable angina patients, 4 weeks of combined therapy of Yiqi Yangyin Decoction (YQYYD) and conventional medicine showed more significant improvement in clinical symptoms and quality of life when compared to patient received conventional treatment only (He et al., 2010). Similarly, another study showed that combined therapy of CHM Xinyue Capsule plus Composite Salvia Tablet with conventional medical treatment could markedly improve myocardial perfusion in acute myocardial infarction patients after revascularization (Li et al., 2009). These clinical studies highlight a great potential in incorporating Chinese Herbal Medicine in the Modern Healthcare System. Historically, there is great abundance of written resources on TCM, and the training of Chinese medicine practitioners in Hong Kong was mostly carried out in a master-apprentice model. Since the early 20th centuries, TCM training become formalized and has been incorporated in the university education. Most TCM training in universities takes 6 years at the undergraduate entry, or 4 years at the graduate entry. Knowledges on TCM are usually delivered alongside with modern medical sciences, including 226

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

anatomy, physiology, pharmacology and pathology, and internal medicine, complemented with clinical internship. Chinese medicine practitioners go through rigorous training both in theory and practice, and are required to have a working understanding of modern medical sciences and medicine. In in Mainland China and Taiwan, there are universities offering integrated program of Bachelor of Chinese medicine, Bachelor of Medicine and Bachelor of Surgery, enabling graduates to be registered as both Chinese medicine practitioner and Western medical practitioner. In Hong Kong, Chinese medicine programs are offered by three public universities, namely the Chinese University of Hong Kong, the University of Hong Kong and the Hong Kong Baptist University. The curriculum at these institutions are designed as per the accreditation requirements of the Chinese Medicine Council of Hong Kong. The degree programs typically cover basic theories of Chinese medicine as well as specialist disciplines of Chinese medicine including diagnostics, Chinese materia medica, Chinese medicinal formulary; internal medicine, external medicine, gynecology, pediatrics, orthopedics and traumatology, acupuncture and moxibustion. These contents are delivered alongside conventional biomedical sciences, providing the graduates the knowledge and skill set to bridge the gap between TCM and Western Medicine. In Hong Kong, in order to become a registered Chinese Medicine Practitioner, one is required to sit for and pass the licensing examination conducted by the Chinese Medicine Practitioners Board of the Chinese Medicine Council of Hong Kong. According to section 61 of chapter 549 of Chinese Medicine Ordinance 2000 (Hong Kong), an eligible candidate is a person who “satisfies the Practitioners Board that at the time of the application he has satisfactorily completed such undergraduate degree course of training in Chinese medicine practice or its equivalent as is approved by the Practitioners Board”. This applies to candidates who completed undergraduate degree in Chinese Medicine in Hong Kong and other countries.

Potential Challenges of Chinese Herbal Medicine in Health Protection in Elderly Difficulties in Defining the Mechanism of Action The pharmacology of CHM is complicated and is difficult to be studied by conventional scientific methods. Moreover, the different complicated components in the Chinese herbal formula are difficult to be identified with. Some examples of herbs and their multi-functions are shown in Table 1. Table 1. Five commonly used herbs in Chinese medicine and their multi-functions English Name

Latin Name

Functions

Balloon flower root

Platycodon grandiflorus

Anti-bloating effects, relieve cough, reduce phlegm, relieve throat pain, anti-bleeding

Puffball Mushroom

Lasiosphaera calvatia

Anti-bleeding, smoothing burning throat

Sweet Wormwood herb

Artemisiae Annuae herba

Anti-malaria, breast cancer, antibacterial and antifungal activity

Capillary Wormwood Herb

Artemisiae Scopariae

Diuretic, excrete dampness and alleviate jaundice, clear heat and remove toxicity

Ginseng

Panax ginseng

Loss of appetite, weakness, vomiting, lack of “yang”, lower cholesterol

227

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

TCM usually are not prescribed in a single herb form but in the form of a formulation. This makes it extremely difficult to analyse the combination of all ingredients and the net pharmacological effect. Like Liu wei di huang wan and Shen qi wan, the basic composition is the same. With the addition of new ingredients and alteration of the percentage of individual components, the medicinal effects may not be the same. Liu wei di huang wan has multi-functions. In a clinical study, it was found that this formula may reduce the risk of diabetic ketoacidosis in patients with type 1 diabetes mellitus (Lien et al., 2016). On the other hand, Shen qi wan was reported to retard the progression of renal failure and alleviate flank pain or tenderness in urolithiasis patients (Lin et al, 2016).

Quality and Safety of Chinese Medicinal Herbs Though there are potential benefits of Chinese Herbal Medicine in health protection in elderly, people may not be aware of possible side effects of TCM (Hon et al., 2004). For example, an investigation has shown the samples of TCM being contaminated with microorganisms, pesticides and heavy metals (Melchart, Hager, Dai, & Weidenhammer, 2016), and may link to liver injury, and gastrointestinal upset. Moreover, although the Chinese government has implemented quality control systems such as the Good Agricultural Practice (GAP), Good Laboratory Practice (GLP), Good Manufacturing Practice (GMP) on the production of Chinese medicinal herbs, there are still rooms for improvement on the quality of TCM. (Xu & Yang, 2009). In Hong Kong, the Chinese Medicine Council of Hong Kong was set up in accordance with the Chinese Medicine Ordinance (Cap. 549F) to rigorously regulate the sales and manufacturing of propriety Chinese medicines, as well as potent or toxic CHMs (Schedule 1). The safety, efficacy, quality as well as the dispensation and labeling of CHMs are assessed before the products can be registered and be available to the practitioners and consumers.

Table 2. The ingredients of Liu wei di huang wan and Shen qi wan Liu wei di huang wan (Six-Ingredient Rehmannia Pill)

Shen qi wan (Kidney Qi Pill)

shou di huang (Rehmanniae Radix Praeparata) 160g

shou di huang (Rehmanniae Radix Praeparata) 160g

shan zhu yu (Corni Fructus) 80g

shan zhu yu (Corni Fructus) 80g

mu dan pi (Moutan Cortex) 60g

mu dan pi (Moutan Cortex) 60g

shan yao (Dioscoreae Rhizoma) 80g

shan yao (Dioscoreae Rhizoma) 80g

ze xie (Alismatis Rhizoma) 60g

ze xie (Alismatis Rhizoma) 60g

fu ling (Poria) 60g

fu ling (Poria) 120g rou gui (Cinnamon) 20g fu zi (Aconiti Radix Lateralis Praeparata) 20g niu xi (Achyranthis Bidentatae Radix) 40g che qian zi (Plantaginis Semen) 40g

228

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Herb-Drug Interactions Stemming from the fact that it is not easy to define the pharmacology of Chinese herbal medicine, it is even more difficult to specifically identify the herb-drug interactions, as in Western medicinal preparations. With the raising popularity of CHM and the advances in CHM research, there are more cases and studies to link the adverse events to the unwanted herb-drug interactions. For example, there are quite a few herbs known to affect the efficacy of warfarin. The first example is ginseng (Lee et al., 2008). Radix Puerariae lobatae (Gegen) has also been shown to offset the anticoagulant effects of warfarin via accelerating the clearance of warfarin from human body (Ge, Zhang, & Zuo, 2016). On the other hand, some herbs such as Ephedrae herba contains ephedrine, which itself is a stimulant and a chemical precursor for the production of methamphetamine (Liu et al, 1993). This herb is harmful to the cardiovascular disease patients in particular, as it can counteract the anti-hypertensives, increasing the blood pressure, and causing tachycardia and palpitation (Haller & Benowitz, 2000). Other known examples of herb-drug interaction include the effect of Artemisia capillaris Thunb on the metabolism of paracetamol, and excessive bleeding in co-administration of Ginkgo biloba and aspirin (Gardner et al, 2007). These adverse events highlight the practical and clinical importance of collaborative efforts between Western and Chinese medicine practitioners to design the medical treatment regime with the best outcomes for the patients. It is worth to note that various counties have their own systems for reporting of adverse reaction, such as the China Food and Drug Administration (CFDA) in China and the Health Sciences Authority Adverse Event Monitoring Unit in Singapore. In Hong Kong, adverse drug reactions are governed by the Drug and Poison Information Bureau, established in 1987 and run by the Division of Clinical Pharmacology of the Chinese University of Hong Kong at Prince of Wales Hospital, its teaching hospital. It gives advice to health care professionals on the diagnosis and treatment of all forms of poisoning and adverse reactions to medicines, and on drug usage in general. It is staffed by nurses, pharmacists, junior physicians, and is backed up by an on-call consultant physician with a specialist interest in clinical pharmacology and toxicology. The bureau has access to various international databases with a listing of over 500,000 drugs, chemical entities and other items. The scope of its experience ranges from modern medicines, traditional Chinese and other remedies, to seafood and pesticide poisoning. All these monitoring systems play an important role to ensure patient and public safety and to serve as the basics for further researches on drug-herb and herb-herb reactions.

DISCUSSION Over the last two decades, Chinese herbal medicine has been widely spread throughout the world. Its enormous therapeutic potentials have been accepted and well recognized, not only in the Asian population such as China, Taiwan, Hong Kong, Japan, Korea and Singapore, but in many non-Asian and Western counties, including Germany, Australia, Canada, United Kingdom and the United States. For example, a TCM hospital was opened in Germany in 1991 with TCM physicians from China to provide treatment according to traditional practice (Melchart et al., 1999). In Australia, the National Institute of Complementary Medicine at Western Sydney University was established by the Australian Federal and New South Wales State Governments in 2007, with a focus on Chinese medicine research and translation into practice. 229

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

In Hong Kong, despite the great influence from the British culture for over 100 years, the use of CHMs remains an important and integral part of the Hong Kong health care services and community culture in seeking medical therapies. Indeed, the government of Hong Kong has been keen to strengthen the status of Chinese medicine and integration of Chinese medicine and conventional medicine in Hong Kong and the setup of the Chinese Medicine Council of Hong Kong in September 1999. It is responsible for the implementation of regulatory measures for Chinese medicine and the registration of Chinese medicine practitioners in Hong Kong. Moreover, the vital role of Chinese medicine in Hong Kong was clearly highlighted in several recommendations in the Consultation Document on Healthcare Reform issued by the Hong Kong Food and Health Bureau in 2000. They include the incorporation of Chinese medicine into the public healthcare system, such as the provision of outpatient Chinese medicine service in the public sector in all the 18 districts, the introduction of Chinese medicine practice in selected public hospitals and to facilitate the development of the integration of western and Chinese medicines. The emerging role of Chinese and integrative medicine in Hong Kong is clearly reflected by the establishment of the Chinese Medicine Research and Service Centre at the Queen Elizabeth Hospital in 2006 to provide out-patient consultations where patients can choose to receive Chinese or combined treatment of Chinese and Western medicine. Moreover, two integrated Chinese and Western medicine centers were established on the same year at Kwong Wah Hospital and Tung Wah Hospital to provide Chinese medicine service to in-patients in some selected clinical conditions. The Chinese Medicine Development Committee set up in 2013 to give recommendations to the government concerning the direction and long-term strategy of the future development of Chinese medicine in Hong Kong. The Hong Kong government proposed, in the 2014 Policy Address, to develop a Chinese medicine hospital to provide Chinese medicine inpatient services. Despite the growing importance of Chinese medicine in Hong Kong, some of the major issues, such as the lack of robust Evidence-Based perspectives and safety issue, are hindering its acceptance and integration with conventional medicine. In 2000, a multidisciplinary team consisting of pharmacist, chemical pathologist, scientist and physician, was formed to provide advisory service on herbal safety to health professionals to address the safety issue CHMs. In addition, a recent report has suggested that Chinese medicine and inter-professional programs should be scaled up to all medical, nursing and allied health professional in Hong Kong in order to facilitate the interaction between Chinese Medicine Practitioners and conventional clinicians towards an inter-professional referral mechanisms (Brosnan, Chung, Zhang, & Adams, 2016). All in all, with the growing popularity, Evidence-Based researches and quality education of Chinese medicine in Hong Kong and around the world, CHMs will continue to extend their coverage for the treatment and management of chronic conditions (e.g. cardiovascular diseases) and impact the evolution of our healthcare system.

CONCLUSION This chapter has provided a review of the important public health challenges in the aging society, and highlighted that the medical cost on chronic conditions like ischemic heart disease and stroke is likely to increase in the future. A brief review on conventional medications for the management of cardiovascular diseases was provided and their side-effects were discussed. Recent research on CHM has proven its effectiveness in managing chronic diseases, particularly cardiovascular diseases. The increasing public interest in CHM, in the midst of the potential adverse events due to inappropriate co-consumption of 230

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

CHM with Western medicine, highlights the need for: (1) more research input, and (2) actual collaboration between Western and Chinese medicine practitioners to design the best medical treatment regime. The latter can be achieved right now, with more Chinese medicine practitioners being equipped with knowledge of Western medicine and modern medical sciences, and the administrative support from the Government.

REFERENCES Aronow, W. S., Ahn, C., & Kronzon, I. (1997). Effect of propranolol versus no propranolol on total mortality plus nonfatal myocardial infarction in older patients with prior myocardial infarction, congestive heart failure, and left ventricular ejection fraction≥ 40% treated with diuretics plus angiotensinconverting enzyme inhibitors. The American Journal of Cardiology, 80(2), 207–209. doi:10.1016/ S0002-9149(97)00320-2 PMID:9230162 Aronow, W. S., Ahn, C., & Kronzon, I. (2001). Effect of beta blockers alone, of angiotensin-converting enzyme inhibitors alone, and of beta blockers plus angiotensin-converting enzyme inhibitors on new coronary events and on congestive heart failure in older persons with healed myocardial infarcts and asymptomatic left ventricular systolic dysfunction. The American Journal of Cardiology, 88(11), 1298–1300. doi:10.1016/S0002-9149(01)02092-6 PMID:11728359 Bajorek, B., Magin, P., Hilmer, S., & Krass, I. (2014). A cluster-randomized controlled trial of a computerized antithrombotic risk assessment tool to optimize stroke prevention in general practice: A study protocol. BMC Health Services Research, 14(1), 55. doi:10.1186/1472-6963-14-55 PMID:24507462 Beckett, N. S., Peters, R., Fletcher, A. E., Staessen, J. A., Liu, L., Dumitrascu, D., ... Bulpitt, C. J. (2008). Treatment of hypertension in patients 80 years of age or older. The New England Journal of Medicine, 358(18), 1887–1898. doi:10.1056/NEJMoa0801369 PMID:18378519 Beckman, J. A., Creager, M. A., & Libby, P. (2002). Diabetes and atherosclerosis: Epidemiology, pathophysiology, and management. Journal of the American Medical Association, 287(19), 2570–2581. doi:10.1001/jama.287.19.2570 PMID:12020339 Brenner, B. M., Cooper, M. E., de Zeeuw, D., Keane, W. F., Mitch, W. E., Parving, H.-H., ... Shahinfar, S. (2001). Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. The New England Journal of Medicine, 345(12), 861–869. doi:10.1056/NEJMoa011161 PMID:11565518 Brignote, M., Auricchio, A., & Baron-Esquivias, G. (2013). ESC guidelines on cardiac pacing and cardiac resynchronization therapy. European Heart Journal, 34, 2281–2329. PMID:23801822 Brosnan, C., Chung, V. C., Zhang, A. L., & Adams, J. (2016). Regional Influences on Chinese Medicine Education: Comparing Australia and Hong Kong. Evidence-Based Complementary and Alternative Medicine. PMID:27379170 Census and Statistics Department Hong Kong SAR. (2014). Thematic Household Survey Report No. 58. Retrieved March 28, 2016, from http://www.statistics.gov.hk/pub/B11302582015XXXXB0100.pdf

231

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Census and Statistics Department Hong Kong SAR. (2015). Hong Kong Population Projections. Retrieved March 28, 2016, from http://www.censtatd.gov.hk/hkstat/sub/sp190.jsp?productCode=B1120015 Census and Statistics Department Hong Kong SAR. (2016). Table 002: Population by Age Group and Sex. Retrieved March 28, 2016, from http://www.censtatd.gov.hk/hkstat/sub/sp150.jsp?tableID=002& ID=0&productType=8 Chan, E., Liu, X. X., Guo, D. J., Kwan, Y. W., Leung, G. P., Lee, S. M., & Chan, S. W. (2011). Extract of Scutellaria baicalensis Georgi root exerts protection against myocardial ischemia-reperfusion injury in rats. The American Journal of Chinese Medicine, 39(04), 693–704. doi:10.1142/S0192415X11009135 PMID:21721150 Chan, G. H. H., Law, B. Y. K., Chu, J. M. T., Yue, K. K. M., Jiang, Z. H., Lau, C. W., ... Wong, R. N. S. (2013). Ginseng extracts restore high-glucose induced vascular dysfunctions by altering triglyceride metabolism and downregulation of atherosclerosis-related genes. Evidence-Based Complementary and Alternative Medicine, 2013, 1–13. doi:10.1155/2013/812096 PMID:24194784 Chen, K. J., & Lu, A. P. (2006). Situation of integrative medicine in China: Results from a National Survey in 2004. Chinese Journal of Integrative Medicine, 12(3), 161–165. doi:10.1007/BF02836514 PMID:17005073 Chinese Medicine Ordinance, Cap 549, Laws of Hong Kong (2000). Chobanian, A. V., Bakris, G. L., Black, H. R., Cushman, W. C., Green, L. A., Izzo, J. L., et al. (2003). Seventh report of the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure. Hypertension, 42(6), 1206-1252. Chu, F. Y., Wang, J., Yao, K. W., & Li, Z. Z. (2010). Effect of Xuefu Zhuyu Capsule on the symptoms and signs and health-related quality of life in the unstable angina patients with blood-stasis syndrome after percutaneous coronary intervention: A randomized controlled trial. Chinese Journal of Integrative Medicine, 16(5), 399–405. doi:10.100711655-010-9999-9 PMID:20535581 Cressman, M. D., & Gifford, R. W. Jr. (1983). Hypertension and stroke. Journal of the American College of Cardiology, 1(2), 521–527. doi:10.1016/S0735-1097(83)80083-7 PMID:6826961 Dahlöf, B., Hansson, L., Lindholm, L., Schersten, B., Ekbom, T., & Wester, P. (1991). Morbidity and mortality in the Swedish trial in old patients with hypertension (STOP-Hypertension). Lancet, 338(8778), 1281–1285. doi:10.1016/0140-6736(91)92589-T PMID:1682683 Dahlöf, B., Pennert, K., & Hansson, L. (1992). Reversal of left ventricular hypertrophy in hypertensive patients a metaanalysis of 109 treatment studies. American Journal of Hypertension, 5(2), 95–110. doi:10.1093/ajh/5.2.95 PMID:1532319 Davies, J., & Davies, D. (2010). Origins and evolution of antibiotic resistance. Microbiology and Molecular Biology Reviews, 74(3), 417–433. doi:10.1128/MMBR.00016-10 PMID:20805405 Drago, F., Ciccarese, G., Broccolo, F., Sartoris, G., Stura, P., Esposito, S., ... Parodi, A. (2016). A new enhanced antibiotic treatment for early and late syphilis. Journal of Global Antimicrobial Resistance, 5, 64–66. doi:10.1016/j.jgar.2015.12.006 PMID:27436469

232

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Elliott, W. J. (2000). Therapeutic trials comparing angiotensin converting enzyme inhibitors and angiotensin II receptor blockers. Current Hypertension Reports, 2(4), 402–411. doi:10.100711906-000-0045-8 PMID:10981176 Fang, H. S., Liu, C. C., Jia, C. H., Chen, Y. H., & Li, C. Y. (2015). Risk of Developing Coronary Artery Disease in Patients with Type 2 Diabetes Receiving Traditional Chinese Medicine Therapy. Journal of Alternative and Complementary Medicine (New York, N.Y.), 21(10), 604–609. doi:10.1089/acm.2014.0079 PMID:26247098 Firuzi, O., Javidnia, K., Gholami, M., Soltani, M., & Miri, R. (2010). Antioxidant activity and total phenolic content of 24 Lamiaceae species growing in Iran. Natural Product Communications, 5(2), 261-264. Flather, M. D., Shibata, M. C., Coats, A. J., Van Veldhuisen, D. J., Parkhomenko, A., & Borbola, J. (2005). Randomized trial to determine the effect of nebivolol on mortality and cardiovascular hospital admission in elderly patients with heart failure (SENIORS). European Heart Journal, 26(3), 215–225. doi:10.1093/eurheartj/ehi115 PMID:15642700 Fleg, J. L. (2008). Improving Exercise Tolerance in Chronic Heart Failure. Journal of the American College of Cardiology, 51(17), 1672–1674. doi:10.1016/j.jacc.2008.01.027 PMID:18436119 Fleg, J. L., Aronow, W. S., & Frishman, W. H. (2011). Cardiovascular drug therapy in the elderly: Benefits and challenges. Nature Reviews. Cardiology, 8(1), 13–28. doi:10.1038/nrcardio.2010.162 PMID:20978470 Fleg, J. L., O’connor, F., Gerstenblith, G., Becker, L., Clulow, J., Schulman, S., & ... . (1995). Impact of age on the cardiovascular response to dynamic upright exercise in healthy men and women. Journal of Applied Physiology, 78(3), 890–900. PMID:7775334 Food and Health Bureau. (2016). Life expectancy at birth. Retrieved March 28, 2016, from http://www. fhb.gov.hk/statistics/en/statistics/life_expectancy.htm Ford, G. A., Choy, A. M., Deedwania, P., Karalis, D. G., Lindholm, C.-J., Pluta, W., ... Olsson, S. B. (2007). Direct Thrombin Inhibition and Stroke Prevention in Elderly Patients With Atrial Fibrillation. Stroke, 38(11), 2965–2971. doi:10.1161/STROKEAHA.107.488007 PMID:17885258 Franse, L. V., Pahor, M., Di Bari, M., Somes, G. W., Cushman, W. C., & Applegate, W. B. (2000). Hypokalemia associated with diuretic use and cardiovascular events in the Systolic Hypertension in the Elderly Program. Hypertension, 35(5), 1025–1030. doi:10.1161/01.HYP.35.5.1025 PMID:10818057 Frishman, W. H., Chiu, R., Landzberg, B. R., & Weiss, M. (1998). Medical therapies for the prevention of restenosis after percutaneous coronary interventions. Current Problems in Cardiology, 23(10), 533–635. doi:10.1016/S0146-2806(98)80002-9 PMID:9805205 Gardner, C. D., Zehnder, J. L., Rigby, A. J., Nicholus, J. R., & Farquhar, J. W. (2007). Effect of Ginkgo biloba (EGb 761) and aspirin on platelet aggregation and platelet function analysis among older adults at risk of cardiovascular disease: A randomized clinical trial. Blood Coagulation & Fibrinolysis, 18(8), 787–793. doi:10.1097/MBC.0b013e3282f102b1 PMID:17982321

233

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Ge, B., Zhang, Z., & Zuo, Z. (2016). Radix Puerariae lobatae (Gegen) suppresses the anticoagulation effect of warfarin: A pharmacokinetic and pharmacodynamics study. Chinese Medicine, 11(1), 7. doi:10.118613020-016-0078-9 PMID:26925159 Ge, Y. (2014). Interpretation of ‘Expert consensus on methicillin-resistant Staphylococcus aureus infection prevention and control’. Chinese Clinical Oncology, 42, 11–12. Gordon, L. A., Morrison, E. Y., McGrowder, D. A., Young, R., Fraser, Y. T. P., Zamora, E. M., ... Irving, R. R. (2008). Effect of exercise therapy on lipid profile and oxidative stress indicators in patients with type 2 diabetes. BMC Complementary and Alternative Medicine, 8(1), 21. doi:10.1186/1472-6882-8-21 PMID:18477407 Grossman, E., Messerli, F. H., & Neutel, J. M. (2000). Angiotensin II receptor blockers: Equal or preferred substitutes for ACE inhibitors? Archives of Internal Medicine, 160(13), 1905–1911. doi:10.1001/ archinte.160.13.1905 PMID:10888965 Gruson, D., Hilbert, G., Vargas, F., Valentino, R., Bebear, C., Allery, A., ... Cardinaud, J. P. (2000). Rotation and restricted use of antibiotics in a medical intensive care unit: Impact on the incidence of ventilator-associated pneumonia caused by antibiotic-resistant gram-negative bacteria. American Journal of Respiratory and Critical Care Medicine, 162(3), 837–843. doi:10.1164/ajrccm.162.3.9905050 PMID:10988092 Hajhashemi, V., Sajjadi, S. E., & Heshmati, M. (2009). Anti-inflammatory and analgesic properties of Heracleum persicum essential oil and hydroalcoholic extract in animal models. Journal of Ethnopharmacology, 124(3), 475–480. doi:10.1016/j.jep.2009.05.012 PMID:19467316 Haller, C. A., & Benowitz, N. L. (2000). Adverse cardiovascular and central nervous system events associated with dietary supplements containing ephedra alkaloids. The New England Journal of Medicine, 343(25), 1833–1838. doi:10.1056/NEJM200012213432502 PMID:11117974 Hansson, L. (1990). How far should blood pressure be lowered? What is the importance of the J-curve phenomenon? Giornale Italiano di Cardiologia, 20(1), 1. PMID:2184071 Hansson, L., Lindholm, L. H., Niskanen, L., Lanke, J., Hedner, T., Niklason, A., ... Björck, J.-E. (1999). Effect of angiotensin-converting-enzyme inhibition compared with conventional therapy on cardiovascular morbidity and mortality in hypertension: The Captopril Prevention Project (CAPPP) randomised trial. Lancet, 353(9153), 611–616. doi:10.1016/S0140-6736(98)05012-0 PMID:10030325 Hao, P. P., Jiang, F., Chen, Y. G., Yang, J., Zhang, K., Zhang, M. X., ... Zhang, Y. (2015). Evidence for traditional Chinese medication to treat cardiovascular disease. Nature Reviews. Cardiology, 12(6), 374–374. doi:10.1038/nrcardio.2014.177-c2 PMID:25917155 He, Q. Y., Wang, J., Zhang, Y. L., Tang, Y. L., Chu, F. Y., & Xiong, X. J. (2010). Effect of Yiqi Yangyin Decoction on the quality of life of patients with unstable angina pectoris. Chinese Journal of Integrative Medicine, 16(1), 13–18. doi:10.100711655-010-0013-3 PMID:20131030 Heart Protection Study Collaborative Group. (2002). MRC/BHF Heart Protection Study of cholesterol lowering with simvastatin in 20 536 high-risk individuals: A randomised placebocontrolled trial. Lancet, 360(9326), 7–22. doi:10.1016/S0140-6736(02)09327-3 PMID:12114036

234

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Hon, E. K., Lee, K., Tse, H. M., Lam, L. N., Tam, K. C., Chu, K. M., ... Leung, T. F. (2004). A survey of attitudes to Traditional Chinese Medicine in Hong Kong pharmacy students. Complementary Therapies in Medicine, 12(1), 51–56. doi:10.1016/j.ctim.2003.12.002 PMID:15130573 Hong, S. J., Wan, J. B., Zhang, Y., Hu, G., Lin, H. C., Seto, S. W., ... Lee, S. M.-Y. (2009). Angiogenic effect of saponin extract from Panax notoginseng on HUVECs in vitro and zebrafish in vivo. Phytotherapy Research, 23(5), 677–686. doi:10.1002/ptr.2705 PMID:19107746 Hoorn, E. J., & Zietse, R. (2011). Hyponatremia and mortality: How innocent is the bystander? Clinical Journal of the American Society of Nephrology; CJASN, 6(5), 951–953. doi:10.2215/CJN.01210211 PMID:21493744 Huang, J., Su, D., Feng, Y., Liu, K., & Song, Y. (2014). Antiviral herbs-present and future. Infectious Disorders-Drug Targets (Formerly Current Drug Targets-Infectious Disorders), 14(1), 61-73. International Diabetes Federation. (2015). IDF Diabetes Atlas (7th ed.). Retrieved March 28, 2016, from http://www.diabetesatlas.org/ Jyrkkä, J., Vartiainen, L., Hartikainen, S., Sulkava, R., & Enlund, H. (2006). Increasing use of medicines in elderly persons: A five-year follow-up of the Kuopio 75+ Study. European Journal of Clinical Pharmacology, 62(2), 151–158. doi:10.100700228-005-0079-6 PMID:16408226 Karalliedde, L. D., & Kappagoda, C. T. (2009). The challenge of traditional Chinese medicines for allopathic practitioners. American Journal of Physiology. Heart and Circulatory Physiology, 297(6), H1967–H1969. doi:10.1152/ajpheart.00944.2009 PMID:19855052 Kengne, F. G., Andres, C., Sattar, L., Melot, C., & Decaux, G. (2008). Mild hyponatremia and risk of fracture in the ambulatory elderly. QJM, 101(7), 583–588. doi:10.1093/qjmed/hcn061 PMID:18477645 Kevelaitiene, S., & Slapikas, R. (2007). A new approach to the treatment of dyslipidemia. Medicina (Kaunas, Lithuania), 44(5), 407–413. PMID:18541958 Kjeldsen, S. E., Julius, S., Hedner, T., & Hansson, L. (2001). Stroke is more common than myocardial infarction in hypertension: Analysis based on 11 major randomized intervention trials. Blood Pressure, 10(4), 190–192. doi:10.1080/08037050152669684 PMID:11800055 Kong, H., & Hsieh, E. (2012). The social meanings of traditional Chinese medicine: Elderly Chinese immigrants health practice in the United States. Journal of Immigrant and Minority Health, 14(5), 841–849. doi:10.100710903-011-9558-2 PMID:22160808 Kubesova, H. M., Weber, P., Meluzinova, H., Bielakova, K., & Matejovsky, J. (2013). Benefits and pitfalls of cardiovascular medication in seniors. Wiener Klinische Wochenschrift, 125(15-16), 425–436. doi:10.100700508-013-0395-2 PMID:23846454 Kumar, V., Abbas, A. K., & Aster, J. C. (2013). Robbins basic pathology. Elsevier Health Sciences. Lakatta, E. G. (2003). Arterial and cardiac aging: Major shareholders in cardiovascular disease enterprises. Circulation, 107(3), 490–497. doi:10.1161/01.CIR.0000048894.99865.02 PMID:12551876

235

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Lam, T. P. (2001). Strengths and weaknesses of traditional Chinese medicine and Western medicine in the eyes of some Hong Kong Chinese. Journal of Epidemiology and Community Health, 55(10), 762–765. doi:10.1136/jech.55.10.762 PMID:11553662 Lee, A. L., Chen, B. C., Mou, C. H., Sun, M. F., & Yen, H. R. (2016). Association of traditional Chinese medicine therapy and the risk of vascular complications in patients with type II diabetes mellitus: A nationwide, retrospective, Taiwanese-registry, cohort study. Medicine, 95(3), e2536. doi:10.1097/ MD.0000000000002536 PMID:26817897 Lee, S. H., Ahn, Y. M., Ahn, S. Y., Doo, H. K., & Lee, B. C. (2008). Interaction between warfarin and Panax ginseng in ischemic stroke patients. Journal of Alternative and Complementary Medicine (New York, N.Y.), 14(6), 715–721. doi:10.1089/acm.2007.0799 PMID:18637764 Lee, V. W., Lam, Y. Y., Yuen, A. C., Cheung, S. Y., Yu, C.-M., & Yan, B. P. (2013). Direct medical cost of newly diagnosed stable coronary artery disease in Hong Kong. Heart Asia, 5(1), 1–6. doi:10.1136/ heartasia-2012-010168 PMID:27326062 Lewis, S. J., Moye, L. A., Sacks, F. M., Johnstone, D. E., Timmis, G., Mitchell, J., & ... . (1998). Effect of pravastatin on cardiovascular events in older patients with myocardial infarction and cholesterol levels in the average range: Results of the Cholesterol and Recurrent Events (CARE) trial. Annals of Internal Medicine, 129(9), 681–689. doi:10.7326/0003-4819-129-9-199811010-00002 PMID:9841599 Li, Y. Q., Jin, M., Qiu, S. L., Wang, P. L., Zhu, T. G., Wang, C. L., ... Shi, D. Z. (2009). Effect of Chinese drugs for supplementing Qi, nourishing yin and activating blood circulation on myocardial perfusion in patients with acute myocardial infarction after revascularization. Chinese Journal of Integrative Medicine, 15(1), 19–25. doi:10.100711655-009-0019-7 PMID:19271165 Liamis, G., Filippatos, T., Liontos, A., & Elisaf, M. (2016). Hyponatremia in patients with liver diseases: not just a cirrhosis-induced hemodynamic compromise. Hepatology International, 10(5), 762-772. Lien, A. S. Y., Jiang, Y. D., Mou, C. H., Sun, M. F., Gau, B. S., & Yen, H. R. (2016). Integrative traditional Chinese medicine therapy reduces the risk of diabetic ketoacidosis in patients with type 1 diabetes mellitus. Journal of Ethnopharmacology, 191, 324–330. doi:10.1016/j.jep.2016.06.051 PMID:27340102 Lin, P. H., Lin, S. K., Hsu, R. J., Cheng, K. C., & Liu, J. M. (2016). The Use and the Prescription Pattern of Traditional Chinese Medicine Among Urolithiasis Patients in Taiwan: A Population-Based Study. Journal of Alternative and Complementary Medicine (New York, N.Y.), 22(1), 88–95. doi:10.1089/ acm.2015.0116 PMID:26359806 Lindholm, L. H., Ibsen, H., Dahlöf, B., Devereux, R. B., Beevers, G., de Faire, U., ... Snapinn, S. (2002). Cardiovascular morbidity and mortality in patients with diabetes in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): A randomised trial against atenolol. Lancet, 359(9311), 1004–1010. doi:10.1016/S0140-6736(02)08090-X PMID:11937179 Liu, Y., Li, N., Jia, Z., Lu, F., & Pu, J. (2014). Chinese medicine shensongyangxin is effective for patients with bradycardia: Results of a randomized, double-blind, placebo-controlled multicenter trial. EvidenceBased Complementary and Alternative Medicine. PMID:24527049

236

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Liu, Y. M., Sheu, S. J., Chiou, S. H., Chang, H. C., & Chen, Y. P. (1993). A comparative study of commercial samples of Ephedrae Herba. Planta Medica, 59(04), 376–378. doi:10.1055-2006-959706 PMID:17235993 Lu, Z., Kou, W., Du, B., Wu, Y., Zhao, S., Brusco, O. A., ... Capuzzi, D. M. (2008). Effect of Xuezhikang, an extract from red yeast Chinese rice, on coronary events in a Chinese population with previous myocardial infarction. The American Journal of Cardiology, 101(12), 1689–1693. doi:10.1016/j.amjcard.2008.02.056 PMID:18549841 MacLaughlin, E. J., Raehl, C. L., Treadway, A. K., Sterling, T. L., Zoller, D. P., & Bond, C. A. (2005). Assessing medication adherence in the elderly. Drugs & Aging, 22(3), 231–255. doi:10.2165/00002512200522030-00005 PMID:15813656 McGill, H. C., McMahan, C. A., Herderick, E. E., Malcom, G. T., Tracy, R. E., Strong, J. P., & ... . (2000). Origin of atherosclerosis in childhood and adolescence. The American Journal of Clinical Nutrition, 72(5), 1307s–1315s. PMID:11063473 Melchart, D., Hager, S., Dai, J., & Weidenhammer, W. (2016). Quality control and complication screening programme of Chinese medicinal drugs at the first German hospital of traditional Chinese medicinea retrospective analysis. Forschende Komplementärmedizin/Research in Complementary Medicine, 23(Suppl. 2), 21-28. Melchart, D., Linde, K., Weidenhammer, W., Hager, S., Liao, J., Bauer, R., & Wagner, H. (1999). Use of traditional drugs in a hospital of Chinese medicine in Germany. Pharmacoepidemiology and Drug Safety, 8(2), 115–120. doi:10.1002/(SICI)1099-1557(199903/04)8:23.0.CO;2-I PMID:15073936 Miettinen, T. A., Pyörälä, K., Olsson, A. G., Musliner, T. A., Cook, T. J., Faergeman, O., ... Group, S. S. S. (1997). Cholesterol-lowering therapy in women and elderly patients with myocardial infarction or angina pectoris. Circulation, 96(12), 4211–4218. doi:10.1161/01.CIR.96.12.4211 PMID:9416884 Okereke, C. E., & Messerli, F. H. (2001). Efficacy and safety of angiotensin II receptor blockers in elderly patients with mild to moderate hypertension. The American Journal of Geriatric Cardiology, 10(1), 42–49. doi:10.1111/j.1076-7460.2001.90855.x PMID:11413935 Olsson, S. B., & Halperin, J. L. (2005). Prevention of stroke in patients with atrial fibrillation. Seminars in Vascular Medicine, 5(03), 285–292. doi:10.1055-2005-916168 PMID:16123916 Panahi, Y., Pishgoo, B., Beiraghdar, F., Araghi, Z. M., Sahebkar, A., & Abolhasani, E. (2011). Results of a randomized, open-label, clinical trial investigating the effects of supplementation with Heracleum persicum extract as an adjunctive therapy for dyslipidemia. TheScientificWorldJournal, 11, 592–601. doi:10.1100/tsw.2011.43 PMID:21403978 Panahi, Y., Pishgoo, B., & Sahebkar, A. (2015). Angiographic findings after supplementation with Heracleum persicum extract: Results of a randomized controlled trial. Heart Views: The Official Journal of the Gulf Heart Association, 16(3), 85. doi:10.4103/1995-705X.164462 PMID:27326348

237

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Pfeffer, M. A., Braunwald, E., Moyé, L. A., Basta, L., Brown, E. J. Jr, Cuddy, T. E., ... Hawkins, C. M. (1992). Effect of captopril on mortality and morbidity in patients with left ventricular dysfunction after myocardial infarction: Results of the Survival and Ventricular Enlargement Trial. The New England Journal of Medicine, 327(10), 669–677. doi:10.1056/NEJM199209033271001 PMID:1386652 Prabhakaran, B., Dowling, E. A., Branch, J. D., Swain, D. P., & Leutholtz, B. C. (1999). Effect of 14 weeks of resistance training on lipid profile and body fat percentage in premenopausal women. British Journal of Sports Medicine, 33(3), 190–195. doi:10.1136/bjsm.33.3.190 PMID:10378072 Ravera, A., Carubelli, V., Sciatti, E., Bonadei, I., Gorga, E., Cani, D., ... Lombardi, C. (2016). Nutrition and cardiovascular disease: Finding the perfect recipe for cardiovascular health. Nutrients, 8(6), 363. doi:10.3390/nu8060363 PMID:27314382 Scandinavian Simvastatin Survival Study Group. (1994). Randomised trial of cholesterol lowering in 4444 patients with coronary heart disease: The Scandinavian Simvastatin Survival Study (4S). Lancet, 344(8934), 1383–1389. PMID:7968073 Seto, S., Lam, T., Tam, H., Au, A., Chan, S., Wu, J., ... Kwan, Y. W. (2009). Novel hypoglycemic effects of Ganoderma lucidum water-extract in obese/diabetic (+ db/+ db) mice. Phytomedicine, 16(5), 426–436. doi:10.1016/j.phymed.2008.10.004 PMID:19109000 Shah, A. B., Morrissey, R. P., Baraghoush, A., Bharadwaj, P., Phan, A., Hamilton, M., & ... . (2012). Failing the failing heart: A review of palliative care in heart failure. Reviews in Cardiovascular Medicine, 14(1), 41–48. PMID:23651985 Shepherd, J. (2002). Resource management in prevention of coronary heart disease: Optimising prescription of lipid-lowering drugs. Lancet, 359(9325), 2271–2273. doi:10.1016/S0140-6736(02)09299-1 PMID:12103306 Sica, D. A. (1999). Old antihypertensive agents-diuretics and β-Blockers: Do we know how and in whom they lower blood pressure? Current Hypertension Reports, 1(4), 296–304. doi:10.100711906-999-00372 PMID:10981081 Špinar, J. (2012). Hypertension and ischemic heart disease. Cor et Vasa, 54(6), e433-e438. Stern, S., Behar, S., & Gottlieb, S. (2003). Aging and diseases of the heart. Circulation, 108(14), e99– e101. doi:10.1161/01.CIR.0000086898.96021.B9 PMID:14530186 Susic, D., & Frohlich, E. D. (2008). The aging hypertensive heart: A brief update. Nature Clinical Practice. Cardiovascular Medicine, 5(2), 104–110. doi:10.1038/ncpcardio1091 PMID:18223542 Tadevosyan, A., MacLaughlin, E. J., & Karamyan, V. T. (2011). Angiotensin II type 1 receptor antagonists in the treatment of hypertension in elderly patients: focus on patient outcomes. Patient Related Outcome Measures, 2, 27. Team, V., Canaway, R., & Manderson, L. (2011). Integration of complementary and alternative medicine information and advice in chronic disease management guidelines. Australian Journal of Primary Health, 17(2), 142–149. doi:10.1071/PY10013 PMID:21645469

238

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Teo, K. K., Yusuf, S., & Furberg, C. D. (1993). Effects of prophylactic antiarrhythmic drug therapy in acute myocardial infarction: An overview of results from randomized controlled trials. Journal of the American Medical Association, 270(13), 1589–1595. doi:10.1001/jama.1993.03510130095038 PMID:8371471 Tully, P. J., Hanon, O., Cosh, S., & Tzourio, C. (2016). Diuretic antihypertensive drugs and incident dementia risk: A systematic review, meta-analysis and meta-regression of prospective studies. Journal of Hypertension, 34(6), 1027–1035. doi:10.1097/HJH.0000000000000868 PMID:26886565 Wang, M. M., Xue, M., Xu, Y. G., Miao, Y., Kou, N., Yang, L., ... Shi, D. (2016). Panax notoginseng saponin is superior to aspirin in inhibiting platelet adhesion to injured endothelial cells through COX pathway in vitro. Thrombosis Research, 141, 146–152. doi:10.1016/j.thromres.2016.03.022 PMID:27043068 Wing, L. M., Reid, C. M., Ryan, P., Beilin, L. J., Brown, M. A., Jennings, G. L., ... West, M. J. (2003). A comparison of outcomes with angiotensin-converting–enzyme inhibitors and diuretics for hypertension in the elderly. The New England Journal of Medicine, 348(7), 583–592. doi:10.1056/NEJMoa021716 PMID:12584366 Wolf, P. A., Abbott, R. D., & Kannel, W. B. (1991). Atrial fibrillation as an independent risk factor for stroke: The Framingham Study. Stroke, 22(8), 983–988. doi:10.1161/01.STR.22.8.983 PMID:1866765 Woo, K. S., Chook, P., Raitakari, O. T., McQuillan, B., Feng, J. Z., & Celermajer, D. S. (1999). Westernization of Chinese adults and increased subclinical atherosclerosis. Arteriosclerosis, Thrombosis, and Vascular Biology, 19(10), 2487–2493. doi:10.1161/01.ATV.19.10.2487 PMID:10521379 World Health Organization. (2014). WHO traditional medicine strategy: 2014-2023. Retrieved July 14, 2016, from http://www.who.int/medicines/publications/traditional/trm_strategy14_23/en/ Yarnell, J., Patterson, C., Sweetnam, P., Thomas, H., Bainton, D., Elwood, P. C., ... Miller, N. E. (2001). Do total and high density lipoprotein cholesterol and triglycerides act independently in the prediction of ischemic heart disease? Arteriosclerosis, Thrombosis, and Vascular Biology, 21(8), 1340–1345. doi:10.1161/hq0801.093505 PMID:11498463 Yusuf, S., Pepine, C. J., Garces, C., Pouleur, H., Rousseau, M., Salem, D., ... Pitt, B. (1992). Effect of enalapril on myocardial infarction and unstable angina in patients with low ejection fractions. Lancet, 340(8829), 1173–1178. doi:10.1016/0140-6736(92)92889-N PMID:1359258 Zhang, Y. C., Chen, R. M., Lu, B. J., Zhao, M. H., & Rong, Y. Z. (2009). Influence of Shengmai Capsule on recovery of living capacity in patients after myocardial infarction. Chinese Journal of Integrative Medicine, 15(5), 333–336. doi:10.100711655-009-0333-3 PMID:19802535

KEY TERMS AND DEFINITIONS Angina Pectoris: Also known as “angina”, it is caused by insufficient blood flow to heart muscles, and often it presents as chest pain, feel of pressure or squeezing. Anticoagulants: They are medicines that help prevent or remove blood clots. Arrhythmia: It occurs when there are changes in the normal sequence of electrical impulses within the heart. This causes changes in the heart rhythm, either by beating too fast, too slowly or irregularly. 239

 Chinese Herbal Medicine in the Management of Atherosclerosis-Related Chronic Conditions

Atherosclerosis: The accumulation of fats, cholesterol and pro-inflammatory white blood cells within the artery wall, leading to a formation of plaques. It causes obstruction of blood flow and the hardening of blood vessels. Cardiomyopathy: It refers to the malfunctioning of heart muscle which causes insufficient supply of blood to the rest of the body. It presents as breathlessness, tiredness and swelling in legs and/or abdomen. Dyslipidemia: An abnormal level of blood lipids, and in developed countries, it often presents as elevated blood triglycerides and/or cholesterol. Hypertension: High blood pressure, usually defined as blood pressure above 140/90. Myocardial Infarction: A condition that underlies heart attack. It is caused by an obstruction of coronary artery which supplies blood to the heart muscle, which leads to death of a portion of the heart muscle. Nutraceuticals: Products derived from food sources that are recognized to provide health benefits in addition to the nutritional value.

This research was previously published in Sustainable Health and Long-Term Care Solutions for an Aging Population edited by Ben Fong, Artie Ng, and Peter Yuen, pages 320-342, copyright year 2018 by Medical Information Science Reference (an imprint of IGI Global).

240

Section 5

Caregivers and Education

242

Chapter 13

Respite Tourism for Family Caregivers Robert Holda Independent Respite Care Specialist, USA

ABSTRACT One of the most misunderstood and unappreciated segments of society in relation to medical tourism is the family caregiver; those caring for a loved one who sacrifice their own employment schedule, their personal time for relaxing and recreation, and often and importantly their own health. The purpose of this chapter is to raise awareness of the plight of family caregivers as an issue for medical tourism, the effects of stress and burnout, and the essential need for respite of body, mind, and spirit for these central assistants in the matter of healthcare for patients. Though healthcare and its subset, medical tourism, are frequently perceived as focused on a “patient”, they also encompass many other individuals and organizations. As addressed here, the focus is on the family member caring for a loved one. The intent is to link the concept of medical tourism as an avenue for relaxation and respite to enhance the wellness of this specific target market.

DOI: 10.4018/978-1-5225-7122-3.ch013

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Respite Tourism for Family Caregivers

INTRODUCTION1 One of the most misunderstood and unappreciated segments of healthcare is the family caregiver, those caring for a loved one who sacrifice their own employment schedule, their personal time for relaxing and recreation, and often and importantly their own health. This brings to mind the importance of each of us having our own “space” to recharge, hence the ideal opportunity of travel and tourism in relation to what the primary task is: the caring for medically and/or psychologically challenged family members. Also, only a caregiver can truly understand another caregiver. Often, they are misunderstood and underappreciated by those who have never provided assistance to a loved one. In turn, they are often overworked and frequently risk their own health in order to keep a family member out of an institution, to enable them to live at home. There are occasional advertisements or news segments about neglect and abuse in various care facilities, which is another reason the average family provider is determined that home is the best place, and where monitoring is not an issue as it would be had the person not been at home. Care-giving is thus a complicated and demanding role, and one not readily understood domestically, let alone in the context of international medical tourism (Casey, Crooks, Snyder, & Turner, 2013). In addition, it may be a surprise to many, but nursing home placement is not always based on the one receiving care, but rather on the existence or otherwise of a caregiver. It is worth noting and explaining in more detail the concept of Respite Tourism for Family Caregivers in order to reduce the chance of any misunderstanding of their role. Therefore, the first objective is to identify the conditions the caregiver encounters. Another objective is emphasizing the importance of respite care. Finally, the intent of the chapter is to identify tourism and travel as an ideal means to achieve this goal.

BACKGROUND As has been outlined elsewhere in this book, medical tourism is a rapidly growing field of medicine and of tourism that makes use of the differential prices of treatment in different countries as a primary motivation for travel, but this travel often is carried out within the wider context of personal health and wellness. Along with the range of services on the medical side, such as chronic conditions related to joints, life-threatening conditions related to vital organs, which if left untreated can soon prove fatal, and cosmetic surgery, there are interventions incorporating a range of wellness therapies involving massage, aroma, diet, and hot or cold water treatments which may have little medical effect at all, but which undoubtedly make some clients feel good, at least temporarily (Erfurt-Cooper & Cooper, 2009). Health and wellness may thus be seen as a framework or background to the practice of medical tourism. Here, the medical treatment itself may be packaged along with more conventional tourism attractions, such as hotels, scenic attractions, climate, regional cuisine, recreational activities, or local culture (Connell, 2013). Any such combination of course depends on the medical condition of the traveler; at one end are cases in which the raison d’être for the travel may be almost entirely medical. For example, heart transplant or hip replacement patients are unlikely to be able exercise very often during his or her treatment. At the other end, a tourist client in search of massage, yoga, aromatherapy, hot spring or mud bath beauty treatments might well value these kinds of amenities much more, and make more regular use of them. In other words, the clientele for medical tourism might range from the completely healthy on the one hand to the terminally ill on the other. This helps to explain the extraordinary number of

243

 Respite Tourism for Family Caregivers

products now available in the medical tourism sector, and the large number of countries that appear to be interested in jumping onto this bandwagon (Chapter 3, this volume). But there is another aspect to this framework for some medical tourists. And this is the situation where the medical patient travels with a support person(s), or care-giver. This is in turn part of the need for an expanding supply of adjunct facilities in a situation of insufficiently researched demand for such facilities. The care giver acts as an additional resource for the medical system, if that system chooses to use this resource. This situation impacts on the quality dimension of medical services, which has increasingly become the decisive competitive factor in the medical tourism market, as well as on the level of health and wellness of the patient themselves (Casey, Crooks, Snyder, & Turner, 2013). Casey, Crooks, Snyder, & Turner (2013), characterize the roles of the caregiver as knowledge broker, companion, and navigator. As knowledge brokers, caregivers facilitate the transfer of information between the medical tourist and formal health care providers as well as other staff members at medical tourism facilities. The companion role involves providing medical tourists with physical and emotional care. And, responsibilities associated with handling documents and coordinating often complex journeys are part of the navigation role. Caregivers provide essential care despite the fact that they are usually not formally trained and paid health professionals (Connor & Adams, 2003). These informal care providers, or caregivers, often provide ongoing essential care in the home, such as administering medications, managing wounds, and assisting with rehabilitation (Ussher, Wong & Perz, 2011), or in local hospitals and other types of residential care settings, where they perform tasks that augment services provided by on-site formal providers, or on the road. Examples of the tasks when on the road include monitoring symptoms and articulating patients’ preferences to foreign health care professionals (Sinding, 2004), and attending to patient healthcare needs as described in this chapter. These functions can lead to burnout, or at the very least resentment over the unrelieved situation of stress caregivers find themselves in, thus the concept of respite care for caregivers discussed in this chapter. The general background to respite care for caregivers may also partially be seen in the concept of the provision of holidays for socially excluded families. This is a concept that has been developed in Europe under the banner of social tourism (Corlyon & La Placa, 2005). Methods of delivery of social tourism have included State or employers’ subsidized holiday centers, state grants and voucher schemes. In France, people paying less than a fixed amount of income tax save out of their pre-tax income for vouchers (cheques vacances) which can be used towards the cost of rail, sea and air travel, as well as in over 135,000 leisure facilities. Any profit made from the scheme finances other programs, including bourse vacances - which helps disadvantaged families who have not previously been able to take a holiday. Further, in any given year more than a third of the UK (and Japanese) population still does not take a holiday at all. In 2002 over 20% of families headed by a couple and nearly 60% of single parents could not afford a one-week holiday for themselves and their children. More than 3.8 million children in the United Kingdom live in families where the parents cannot afford a holiday, and 2.6 million are in families where even day trips are beyond their means (UK Office for National Statistics, 2005) Not being able to take a holiday once a year is now recognized in government policy as an aspect of poverty. The UK Children Act (2004) also refers to leisure as a component of general child well-being. Thus, the evidence base is growing to show that encouraging family holidays for low-income groups may be a worthwhile exercise in terms of the benefits for individuals, families, communities, the environment and the economy (Corlyon & La Placa, 2005). These benefits include relaxation, stress-reduction, improvements in relationships, widening horizons, improvement in mental health and enhanced self-

244

 Respite Tourism for Family Caregivers

confidence. A similar model to the French cheques vacances scheme already exists in the UK in the form of childcare vouchers which are purchased through employers and are tax exempt up to £50 a week. Whether this can be replicated to provide a holiday savings scheme to meet the needs of caregivers would benefit from further exploration. From November 2005, a government-backed scheme which was piloted earlier that year has seen some UK travel agencies offering various reductions to families booking vacations during the school holidays - a time when their holiday costs have typically been more expensive than at other times of the year. There is evidence that some charities and voluntary organizations in the UK are driving forward the social tourism agenda by delivering services and/or lobbying the government to ensure that policy makers are aware of the growing need for social tourism. However, it is open to debate whether the voluntary sector should assume responsibility for the task or whether it should be the function of government, working alone or in conjunction with private sector companies. Although the not-for-profit sector already has some of the infrastructure to administer provision of holidays for families in need, more extensive government funding is probably required to widen this provision. Of course, this system does not strictly cover respite care, but the forms of social tourism and various international agreements, such as the UN Convention on the Rights of the Child and the Universal Declaration on Human Rights, offer indirect support for the view that holidays are a social right by including the right to rest and leisure, and this can easily be extended to the caregiver needs of the medical tourist, and the needs of the caregiver themselves, as much as they can to the broader concept of social tourism.

THE FACTS OF CAREGIVING Caregiver-Companions in Medical Tourism As we have seen, caregiving occurs in medical tourism when family members, friends, or supportive individuals accompany a patient seeking private medical treatment abroad (SFU, 2013). These individuals, often referred to as caregiver-companions, may provide support during planning stages, while abroad, and upon the return home. They are often in contact with the staff in medical tourism facilities who provide support, information and advice. Research suggests that caregiver-companions are typically well-received by industry employees, but that they can also present some challenges to facilities and staff (SFU, 2013; Casey, Crooks, Snyder, & Turner, 2013). Given the integral roles that caregivers can play in many situations (particularly while they are abroad with their patients), the practice of medical tourism and thus the industry that supports it seems highly dependent on their unpaid care work. As with the informal workers in many industries, these individuals are effectively overlooked shadow workers (Armstrong, Armstrong, & Coburn, 2001). They are usually unpaid, untrained, and largely unrecognized as care providers, within what is often reported as a highly lucrative industry (see Chapters 1 and 2, this volume). Casey, Crooks, Snyder, & Turner (2013) believe that adopting a critical perspective on caregivers is essential to effectively address the question ‘who ultimately benefits from medical tourism? This latter issue is a major one in the debate over the practices of medical tourism (Hall, 2011; Connell, 2013); and is central to the health equity debates that surround the medical tourism industry (see Chapter 6, this volume).

245

 Respite Tourism for Family Caregivers

What Challenges Can Caregiver-Companions Pose for Medical Tourism Facilities? Simon Fraser University’s Medical Tourism Research Group (Vancouver, British Columbia, Canada) has identified from interviews with international patient coordinators who interact with caregiver-companions, some of the risks and challenges of caregiver-companions’ participation in medical tourism (SFU, 2013): • • • •

Bringing a caregiver for support will increase the financial expenses for patients through flights, accommodation, and food costs. Caregivers often also require emotional and instructional support from staff, which may redirect time and resources away from the patient; Confusion over roles can arise when caregiver-companions assist with daily activities that are usually the responsibility of nurses, such as toileting and recovery exercises. The overlap in care can impede patient symptom monitoring and continuous record keeping; Care quality for the patient may be compromised due to the disregard of facility norms by caregiver-companions, such as visiting limits. Both over-involved caregiver-companions and passive or neglectful ones can limit the facility staff’s ability to provide the best care possible; It is common for caregiver-companions to experience stress from the uncertainty about the patient’s health outcomes and from lack of trust in the facility, system, and country in which the procedure takes place. The emotional strain and anxiety can have negative health impacts for the caregiver. They are also subject to the general risks of travel, such as exposure to unsafe drinking water, theft, and financial exploitation, as well as everyday risks.

What Are the Benefits? On the positive side support, advice, and education by medical tourism facility staff can reduce stress, excess burdens, and negative outcomes for caregiver-companions, and the patients themselves benefit very greatly from having the caregiver around. The following are sample questions with answers to help with the clarification of the positive nature of this sector of medical tourism:

How Large Is the Market, and How Is It to Be Understood? There’s no doubt that caregiving should be understood as a global market (see Indiana Continuity of Care Association, n.d.). It would be hard to imagine there is any country which does not have a subset of its population who are receiving some level of care from a family member or other caregiver. In short, the size of the market is unlimited (Global Wellness Institute and SRI International, 2013). Within this, the needs of the caregiver themselves, the major focus of this chapter, are also important. As mentioned in this chapter, public awareness to the need for family members caring for a loved one to have renewal time away from their stressful situation can be exposed via multiple media channels. Also, awareness through various associations, corporate sponsorship, and related professionals in health care and tourism would be most helpful. Interests would depend upon the country, culture, regional and local demographics of the population. There is no limit. Regarding the issue of affordability, this would also depend on those same factors. Tourism for family caregivers does not have to raise overwhelming concerns for the medi-

246

 Respite Tourism for Family Caregivers

cal tourist’s family budget. Even if people take a short “get-away” regionally by car or another form of economical transport, this still would provide time away. The caregiver and family can determine what they can afford.

Would Families Be Willing to “Abdicate” or Assign Care to Someone They Don’t Know or Trust to Enable the Caregiver to Obtain Respite From Their Tasks? This should not be a concern whatsoever. No one who is entrusting care of a loved one would ask someone they really don’t know or trust. The caregiver seeking respite first can involve another family member if one lives close by and they know would give the same loving care. Another option would be to involve a trusted neighbor. Often, neighbors can be as concerned and helpful as family members. If a care facility is necessary to help temporarily, it of course has to meet licensing and legal guidelines. Also, one can seek the assistance of those from faith communities to help while one is seeking respite. So the issue of assigning care to someone unknown or not trusted should not even enter the “picture”.

What Are the Potential Legal Liabilities? This issue, while perhaps a concern to some, should not be a distraction to the one seeking respite travel. The one providing most of the care to a loved one needs to clear his or her mind of a lot of the extra “clutter” in the temporary help of another with issues such as this and the previous one mentioned. All families for example should already have an attorney involved with some matter of their household (Wills, financial, family law, and so on). An assigned Power of Attorney can also focus on this situation should any concern arise. But the main focus for the person needing respite is to have relief from caregiving and all related issues! The last thing the person needs is to be worrying about “what if” issues.

What Is Unique to a Caregiver Association That a General Travel Agency Doesn’t Already Offer? This is an interesting thought for consideration. Yes, travel agencies do compete and offer quite a wide variety of packages; many through the year, and of course well in advance of holidays. The unique aspect about the concept of “Respite Tourism for Family Caregivers” is the specialized and targeted market. We do not see or hear of promotions from travel agencies specifically addressing travel as a means of renewal of body, mind, and spirit for the weary family caregiver. Neither do we hear of such promotions from airlines or cruise ship companies. How often have faculty and researchers discussed this specific aspect of the Hospitality Industry?

How Will Brand Awareness About Caregivers Be Communicated? Awareness and communication about caregiving can be raised via many channels: travel agencies and corporations associated with the tourism and hospitality industry; specific promotions; all forms of media (online, print, radio/television); discussions within and among associations and organizations; and human services divisions in government are some examples. Brand awareness can be communicated in unlimited ways; there basically needs to be an interest and effort put forth in promotion (see Chapter 6, this volume; Hall 2011; Connell 2013). In this regard, the Indiana Continuity of Care Association 247

 Respite Tourism for Family Caregivers

(USA) has provided a list of 23 facts regarding the millions of caregivers who help care for an ailing family member. A partial list gives one pause, and supports consideration of the implications of medical tourism caregiving on these dedicated servants and on society in general (Indiana Continuity of Care Association, n.d.): • • • • • • • •

One-quarter of the adult population worldwide helps to care for family members or friends; The average family caregiver in the USA provides 18 hours of care per week; 20% provide “constant” care” or 40 hours a week; The average age of the American caregiver is 46; the average age of the person being cared for is 77; The average out-of-pocket expenses for an American family caregiver are $171 per month. Total non-reimbursed monthly expenses for family caregivers is $1.5 billion; Caregivers who quit or drastically reduced their hours have the highest level of stress, and relatives with the most severe behavioral problems. Leaving the workplace causes an annual income loss of about $20,400 per employee; Family caregivers would account worldwide for an estimated $257 billion annually in services, IF they were paid; The average cost of nursing home care in the US is over $51,000 a year, yet funding is not available to help family members keep their loved one at home; This is a crisis of international proportions. In 2013 the US Congress allocated $125 million to develop new programs for family caregivers, and other countries such as Singapore have also discussed policy responses to this problem (Chua, 2005).

OTHER ISSUES AND PROBLEMS American businesses lose between $11 and $29 billion a year in productivity costs due to caregivingrelated work interruptions (Indiana Continuity of Care Association, n.d.). Caregivers often experience troublesome feelings such as: 1. Resentment about demands, real and imagined; 2. Felling exhausted from balancing caregiving with the competing demands of personally living every day; 3. Depression as life changes drastically; 4. Helplessness as the reality and enormity of managing caregiver responsibilities impacts your life; and 5. Anger is common among caregivers and comes from emotional stress of caring for another.

HEALTH ISSUES There is a powerful connection between the body and mind. Stress affects emotions, such as anger, grief, and overwhelming frustration (Indiana Continuity of Care Association, n.d.). This, in turn, can lead to actual physical symptoms for the caregiver: 248

 Respite Tourism for Family Caregivers

• • • • • • • • • •

High blood pressure; Stomach aches; Dizziness; Acid reflux; Blurred vision; Headaches; General muscle soreness; Sleeplessness; Exhaustion; and Depression.

In summary, the family caregiver support issue crosses all areas of society. It is not limited just to the aged and infirmed. For example, parents of autistic children are one group of people who are in need of respite from caring for their young ones with special needs. The Autism Society of Indiana recently received a generous gift for a pilot program to create a position for a Respite Coordinator, and also to provide respite services to five families within the state for one year. This is just one example of enhancing the quality of life for the patients and their families, and the growing response to this problem. Also, caregiver respite is not strange even to national celebrities: a couple of years ago, Head Coach Chuck Pagano of the Indianapolis Colts NFL Football Team was diagnosed and treated for cancer. There was an overwhelming support locally, regionally, and nationally via fans, the general public, and media, who all offered caregiving solutions. Thankfully, he as recovered, and in 2013 returned to the football field to lead the team.

SOLUTIONS AND RECOMMENDATIONS It is worth noting what joy even an afternoon away from caregiving stresses can bring. When an alternative provider is scheduled for 3 hours, it actually often becomes 5 hours. The normal caregiver usually always makes the most of having lunch, shopping and relaxing away from home; so much so that it is obvious they need more time away from their duties. Upon returning home, one would have thought the caregiver was gone a week just by observation of the smile and radiance on their face! Think of what reaction would have been had he or she actually traveled to a tourism destination for a week! Years ago, Medical Tourism was practically never heard of. Now, as society is at a much faster pace than during the 1960’s, more discussion, resources, and awareness about this industry are available through social media. The medical tourism aspect of respite caregiving is based on personal experience: 1. Reaching out is very important. For example, a recent announcement was released from the Autism Society of Indiana. This organization is the recipient of a generous gift to fund a pilot respite program that will provide respite services for Indiana families for one year who have a child with Autism. The A.S.I. Reports so many families trying to find a person to assist is one of the most needed supports for the well being of the family. Taking a break from non-stop caregiving is vital for maintaining one’s health and wellbeing (Autism Society of Indiana, 2014); 2. Seeking out sources of information on social media. There are numerous websites relating to medical tourism. The family caregiver should be encouraged to seek out such resources in order to advise 249

 Respite Tourism for Family Caregivers

their patients in addition to the advice given by the healthcare system. Their health and wellness is a legitimate aspect of medical tourism. A few examples of helpful sites on the web are: a. National Association of States United for Aging and Disabilities, http://www.nasuad.org (2014); b. The Tourism Observatory for Health, Wellness, and Spa http://www.thetourismobservatory. org (2013); c. Wellness Travel Journal, http://www.wellnesstraveljournal.com (2014). 3. Public awareness; media exposure on this subject is essential and can truly be of help to family caregivers. It was encouraging to note recent coverage on a national television network about the Elizabeth Dole Foundation, which specifically focuses on an important segment in society, the family caregivers of military personnel who have been injured in their service. They are unsung heroes who are also giving to their country; 4. New Legislation. There already has been new legislation introduced in the U.S. Congress focusing on family caregivers, and specifically, military family caregivers. This has taken place as a result of the exposure of the Elizabeth Dole Foundation mentioned above (The Elizabeth Dole Foundation, 2014); 5. Promotion of Destination. One of the best resources for promoting relaxing, stress-free, beautiful destinations for caregiver respite are tourism boards of various countries. One can then examine regional and local destinations. Various corporations involved with tourism and medical tourism (such as hotels, airlines, and cruise ships) can also advertise special programs and rates focusing on caregiver respite. One excellent example of a destination for renewal of body, mind, and spirit is the country of Belize, located in the western Caribbean of Central America (Figures 1, 2, and 3). There, a visitor will find a relaxing life style, in addition to beauty that is conducive for an atmosphere of serenity. The Cayes or islands offer great activities that one most likely would not have back home. There are, of course, a wide variety of destinations for respite that would fall within most people’s economic situation. As mentioned earlier, there are a variety of tourism boards and visitors centers at different geo-graphical levels. Perhaps family members or friends of caregivers may consider providing financial assistance as a gift to the caregiver.

FUTURE RESEARCH DIRECTIONS Respite Tourism for Family Caregivers, basically not a well-known concept, can and should be the focus of new research projects in a variety of disciplines as a part of medical tourism. Consideration of internships in secondary and higher education to experience the issues of caregiving would surely provide a deeper appreciation for the concept of “respite tourism”. By all means, the corporate world can become involved with this aspect of the workplace. Though technology has become more prevalent over the years, one cannot forget the most valuable resource to any organization is the people. HR, Personnel, and Employee Assistance Programs are urged to consider this concept. Employee workshops, interaction with other organizations and community involvement can all play an important role.

250

 Respite Tourism for Family Caregivers

Figure 1. Belize

Source: After Casado Internet Group (n.d.)

Figure 2. The needs of the caregiver are also important in medical tourism Source: The Author.

251

 Respite Tourism for Family Caregivers

Figure 3. The needs of the caregiver are also important in medical tourism (2)

Source: The Author

CONCLUSION The principal aim of this chapter was to focus on the needs of the family caregiver and their relation to medical tourism. For a fuller exposition of the caregiving concept and its value in medical tourism please see Casey, Crooks, Snyder, & Turner (2013). A background of the overall health and implications of stress on caring for a loved one was also introduced. This was to raise awareness on a specific segment of society which is becoming ever more prevalent. It is practical to conclude, therefore, that there is also a need for respite care for caregivers. Time away for health and wellness of the family caregiver is essential, and this should involve renewals of body, mind, and spirit. Therefore, it is recommended this be an emerging trend further studied by the Hospitality and Tourism industries (Hazel, 2005). Recommendations were provided above on future research so this issue can be addressed further. While scientific findings are important to providing conclusions and suggestions, the human element must not be forgotten in the process. Yes, respite tourism for family caregivers will surely give this group something to smile about. The concept of “Respite Tourism for Family Caregivers” is not intended to be perceived as a business venture addition to the discussion of the role of caregivers in medical tourism, or to necessitate a lot of detail and specifics, which would be distractions in the task of defining the industry of medical tourism. The sole intention here was to raise awareness of a mission or cause, which the Hospitality and Tourism Industry, and those performing research in academia, should consider (Tourism Observatory for Health, Wellness, & Spa, 2013). By reviewing the facts of the toll that caregiving for a loved one takes on another family member, we can see that this could and should be an important factor in the consideration of medical tourism. Discussion and research on this can be unlimited; it is an opportunity to open doors, and discover the yet “undiscovered” role of caregivers and their own needs in medical tourism (Casey et al. 2013). Again, this is NOT a proposal for a business or just another aspect of commercialization, but should be perceived as a mission or cause to which we can make a contribution, thus improving the lives of many unsung heroes. Finally, let me leave the reader with the heartfelt comments of one person who received care giver assistance, and who, in the USA at least is a well-known sports figure (Coach Pagano is Head Coach of the Indianapolis Colts NFL Football Team). He acknowledged their importance in the following words:

252

 Respite Tourism for Family Caregivers

I don’t know what I would have done without the great care given to me, not only by professionals, but also my family and friends. I know they are facing some challenging times that are not the easiest to push through. Tough days are inevitable, whether you are fighting a disease or any other battle. Know that it is in these extremely difficult times that their strength is revealed in greater ways than they will ever imagine. (Pagano, personal communication, 2014)

REFERENCES Armstrong, P., Armstrong, H., & Coburn, D. (2001). The Political Economy of Health and Care. In P. Armstrong, H. Armstrong, & D. Coburn (Eds.), Unhealthy Times: Political Economy Perspectives on Health and Care in Canada (vii-x). Toronto: Oxford University Press. Autism Society of Indiana. (2014). Caregivers of Autistic Persons - A Case Study. Retrieved from www. autismsocietyofindiana.org Casado Internet Group. (n. d.). Target Destination: Ambergris Caye, Belize. Retrieved from www. ambergriscaye.com Casey, V., Crooks, V. A., Snyder, J., & Turner, L. (2013). You’re dealing with an emotionally charged individual…: An industry perspective on challenges posed by medical tourists’ informal caregivercompanions. Globalization and Health, 9(1), 31. doi:10.1186/1744-8603-9-31 PMID:23889860 Chua, B. H. (2005). Welfare Developmentalism in Singapore and Malaysia. In H. Kwon (Ed.), Transforming the Developmental Welfare State in East Asia, (pp. 98–117). Basingstoke: Palgrave Macmillan/ UNRISD. Connell, J. (2013). Contemporary Medical Tourism: Conceptualization, Culture and Commodification. Tourism Management, 34, 1–13. doi:10.1016/j.tourman.2012.05.009 Connor, S., & Adams, J. (2003). Caregiving at the end of life. The Hastings Center Report, 32(2), S8– S12. PMID:12762185 Corlyon, J., & La Placa, V. (2005). Policy Research Bureau Briefing Paper. London: Family Holiday Association. Erfurt-Cooper, P., & Cooper, M. (2009). Health and Wellness Tourism: Spas and Hot Springs. Bristol, UK: Channel View Publications. Hall, C. M. (2011). Health and medical tourism: A kill or cure for global public health? Tourism Review, 66(1/2), 4–15. doi:10.1108/16605371111127198 Hazel, N. (2005). Holidays for children and families in need: An exploration of the research and policy context for social tourism in the UK. Children & Society, 19(3), 225–236. doi:10.1002/chi.838 Indiana Continuity of Care. (n. d.). Caregiver Statistics. Retrieved from www.in.coc.org

253

 Respite Tourism for Family Caregivers

Legislation.gov.uk. (2004). UK Children Act. Retrieved from www.legislation.gov.uk/id/ukpga/2004/31 National Association of States United for Aging and Disabilities. (2014). Policy Directions. Retrieved from www.nasuad.org SFU Medical Tourism Research Group. (2013). Industry Perspectives on Informal Caregiving in Medical Tourism. Vancouver, Canada: Simon Fraser University. Sinding, C. (2004). Informal care–two tiered care? The work of family members and friends in hospitals and cancer centers. Journal of Sociology and Social Welfare, 31, 69–86. The Elizabeth Dole Foundation. (2014). Caring for Military Families. Retrieved from www.elizabethdolefoundation.org The Global Wellness Tourism Economy. (2013Global Wellness Institute & SRI International. Stanford: SRI. Tourism Observatory for Health. Wellness & Spa. (2013). Global Spa and Wellness Tourism Monitor. Retrieved from www.thetourismobservatory.org UK Office for National Statistics. (2005). UK 2005. London: TSO. Ussher, J. M., Wong, W. K. T., & Perz, J. (2011). A qualitative analysis of changes in relationship dynamics and roles between people with cancer and their primary informal carer. Health, 15(6), 650–667. doi:10.1177/1363459310367440 PMID:21177721 Wellness Travel Journal. (2014). Wellness Tourism Worldwide. Retrieved from www.wellnesstraveljournal.com

KEY TERMS AND DEFINITIONS Autism: A condition, usually beginning in childhood, which causes problems in forming relationships and communicating with other people. Caregiver: A person who gives help and protection to someone, such as Children, the elderly, or someone who is ill. Emotions: A mental reaction accompanied by physiological and behavioral changes in the body. Respite: A period of time when one is able to stop doing something that is difficult. Respite Tourism: Traveling away from a difficult situation for the purpose of renewal of body, mind, and spirit. Stress: A factor that can cause body and/or mental tension and may be a factor in causing disease.

ENDNOTE

1

This chapter is dedicated to my parents, Nicholas & Rosella Holda.

This research was previously published in Current Issues and Emerging Trends in Medical Tourism edited by Malcolm Cooper, Kazem Vafadari, and Mayumi Hieda, pages 218-231, copyright year 2015 by Medical Information Science Reference (an imprint of IGI Global). 254

255

Chapter 14

Turning PAGES With Health Coaching and Family Involvement Jennifer Lynne Bird Florida Atlantic University, USA Eric T. Wanner Palm Beach Sports Medicine & Orthopaedic Center, USA

ABSTRACT This narrative provides a foundation for the PAGES family coaching program. PAGES is an acronym for practice patience, accept the present, gather information, encourage, and self-care. Each part of the acronym represents advice that family members of patients in hospitals can implement into their lives. When patients attend group physical therapy classes in a hospital after surgery, it helps to have family members present to offer support during the healing process. However, sometimes when coaching loved ones, family members can get emotionally involved and lose their objectivity. A health coach can provide the missing link of “teaching the teachers” by demonstrating effective coaching practices. The goal of the chapter is to introduce you as the reader to the PAGES program so you will simultaneously learn about a new initiative as well as reflect on ways to apply the information to your own life.

DESIGNING PAGES PAGES, the program described in this writing, happened because of a large foundation of writing. Rarely does any single piece of writing happen in isolation. Program development and new learning opportunities occur because of the outcomes of previous writing and research. Often different pieces of writing fit together like puzzle pieces to form a larger picture. Heard (1995) confirms, “the obstacles I face – lack of time, too many projects at once – as well as the obstacles all writers face – rejection, criticism, doubts and insecurities, unfinished poems and stories – are impossible to avoid and can be valuable teachers” (pp. 38-39). Writers consistently overcome obstacles to develop new ideas. Jennifer, a health coach, has completed extensive writing and research with Eric, a physical therapist and research consultant, which DOI: 10.4018/978-1-5225-7122-3.ch014

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Turning PAGES With Health Coaching and Family Involvement

provided a foundation upon which to scaffold this new idea. In this digital age of technology, it becomes important to remember that sometimes it is okay to put down the smart phone, turn off the television, and encourage families to have a conversation with each other. Family involvement becomes the heart and soul of PAGES. While physical therapists, health coaches, and other medical professionals can offer support to a hospital patient, when the patient goes home from the hospital, the relay baton of care gets passed to the family member caregiver. Health coaching focuses on vision and values to help people build bridges and make connections between where they are now and where they want to be. Health coaches work with people who are mostly healthy but want to make lifestyle changes such as getting more sleep or eating healthier. Health coaches also work with patients by helping them align their vision and values with the treatment plan prescribed to them by a medical practitioner such as a physical therapist. Like pages being turned in a book, health coaches encourage patients to write the next chapters in their health stories. Cameron (1998) believes, “we need to decide that we will, one, write no matter what and, two, share that writing no matter what” (p. 135). Health coaches frequently ask people questions to guide them to their goals, ask them to write their goals, and then share the goals to achieve ownership of the accomplishments. However, once a patient finishes a session with a health coach, it becomes his or her responsibility to take the necessary steps to achieve the goals. Family members who are willing to act as cheerleaders for their loved ones during the process serve as an additional source of support during the healing journey. This narrative provides a foundation for the PAGES family coaching program. While the program is designed for the families of hospital patients, you as the reader of this chapter may discover you can apply the information to your life in some way even if you do not have a loved one who is a hospital patient. PAGES is an acronym that serves as a reminder for families of hospital patients to reflect on what they need to do to help their loved ones who are hospital patients recover after surgery. The designers used expertise in health coaching, curriculum design, teaching, writing, and research in a physical therapy clinic to create the PAGES program with the hope it will make a difference in the lives of hospital patients and their families.

THE PAGES FAMILY COACHING PROGRAM Helping Patients Turn New Pages and Write New Chapters in Their Healing Journeys To help your loved one who is a patient: • •

256

Practice Patience: Healing is a journey. No one can wave a magic wand and provide an immediate cure. Celebrate progress, no matter how small. Accept the Present: Feelings of guilt, anger, and frustration are normal, but are not helpful when coaching. No matter what happened in the past, this is where you are now. Worrying about the future only causes additional stress. Try your best to remain in the present moment. Consider writing in a journal to sort through your feelings.

 Turning PAGES With Health Coaching and Family Involvement

•

• •

Gather Information: The medical professionals such as doctors, physical therapists, occupational therapists, nurses, and speech therapists are here to help you. Ask questions, and listen to their instructions. Consider bringing a notebook with you to write down information so you don’t have to remember it. Encourage: During the healing journey, patients need cheerleaders. You are a source of hope and light during this process and a little support can make a large difference. Self-Care: In order to take care of your loved one, take care of yourself too. You can better help someone else when your own needs, such as hunger and sleep, are met too.

Health Coaching and the Foundation for PAGES This idea for the PAGES program began once I (Jennifer) began working as a health coach at a hospital. So far during my time at the hospital I have been working with staff members who want to make health adjustments to their lives. My colleague Eric, a physical therapist, and I have also been working with staff members who have a physical health issue such as back pain, knee pain, or neck pain. Eric gives the patients specific exercises to complete or performs appropriate manual techniques after diagnosing their condition, while I talk with them to assess the importance of the treatment plan to them and their confidence in completing the treatment plan. This helps us see the patient’s barriers to the recovery process so we can help the person overcome those barriers. This process has made a positive difference in patients’ healing and has been very rewarding for us as practitioners. The hospital is opening a new building for inpatient rehabilitation. For the theory behind the best practices used in the building, as the research consultant for the project, Eric used the writing of orthopedic surgeon Marshall Steele. Steele (2009) suggests that health care providers “develop the tools and systems needed for effective and consistent patient education and expectation setting” (p. 99). One resource that research found would be helpful for patients at the hospital is the practice of family coaching, where family members of patients assist the physical therapists as the patients complete exercises. Jones, Brady, and Gaunt (2009) describe the role of family coaches as, “one of the coaches’ responsibilities is to come to post-op group therapy classes, where they act as assistant physical therapists. Coaches encourage their loved ones and are shown and taught the dos and don’ts by the physical therapist. Many times, coaches are equipped with digital counters to ensure completion of the activities. If no family member is available, hospital volunteers often take up the coaching role” (p. 102). Family members as coaches can serve as an additional source of encouragement for patients as they complete their physical therapy treatment plan. Throughout the family coaching process, health coaches can provide education and support for the families of patients. While family members will have the best intentions when serving as coaches for their loved ones, it is easy for the family to become emotionally involved because the outcome of the patient’s progress affects the entire family. Health coaches care about the patients and families but also keep an objective distance from the individual situations unfolding within each family. Health coaches can provide resources for family members to take care of themselves as they take care of their loved ones. Most importantly, health coaches work with physical therapists to “teach the teachers,” the family member who will take over the patient’s care once the patient returns home. The importance of this is once the patient goes back home there will be a continuity of care for the patient while he or she is awaiting home physical therapy and then out-patient physical therapy. This can lead to quicker recoveries for patients.

257

 Turning PAGES With Health Coaching and Family Involvement

Greater Healing Gains Through Family Involvement Evidence exists that family involvement leads to greater healing for patients. Ryan, Wade, Nice, Shenefelt, and Shepard (1996) discovered, “family involvement was found to be a significant aspect of a patient’s rehabilitation” (p. 159). Through a series of interviews with forty physical therapists, the researchers learned, “the shift from hospital to home care increases the effect on the family unit and significantly expands the role of the physical therapist in involving the family in the rehabilitation process. Such trends in healthcare require that physical therapists have effective, time-efficient strategies for involving family members in a way that ensures the highest potential for optimal recovery of the patient” (p. 160). However, some family members may have barriers in their family dynamics to work thorough while attempting to guide their loved one who is a physical therapy patient through an exercise treatment plan. Physical therapists can expertly inform family members of patients about the patient’s at home treatment plan. Nevertheless, due to demands by insurance companies and the health care system for clinicians to consistently demonstrate increased productivity, a physical therapist may not be able to have a lengthy conversation with a patient’s family about how the family is navigating the crisis of the patient’s surgery and how everyone can move forward together as a family unit. This is where health coaches can provide much needed assistance for both physical therapists and families. The authors of the family involvement research study observed, “the success with a family adapts to crisis depends on a variety of factors from financial resources to the family’s expectations and knowledge of the patient’s condition” (p. 160). Health coaches are trained in psychology but are not psychologists; if a family wants to have a lengthy session about past issues in the family dynamics the health coach will make a referral to a psychologist. The role of the health coach is to help the patient, and therefore also the family members, to focus on the present situation and offer strategies and resources for breaking down barriers and overcoming obstacles, that help maintain forward momentum. The researchers concluded that “the physical therapist’s knowledge of what the family is experiencing is crucial in guiding the family towards appropriate goal setting” (p. 175). The emerging field of health coaching did not exist when this research study was conducted, but health coaches, physical therapists, and families can all work together to ensure elite results for the patient.

DESIGNING A CURRICULUM OF FAMILY INVOLVEMENT Creating a new curriculum, whether it is at a school or a hospital, takes thought and effort. A teacher can’t just walk into a classroom, wave a copy of The Great Gatsby at students, and teach without a lesson plan or a curriculum to support that lesson plan. Similarly, it helps the families of patients to know the expectations before they serve as assistants to the physical therapists. As Marshall, Sears, and Schubert (2000) explain, “we believe that the essence of curriculum studies lies in the way each educator internalizes fundamental questions of what curriculum is and should be – and the attendant whys, whens, and whereas of its enactment” (p. 3). Anyone designing a new curriculum needs to ask the questions of why a lesson is being taught, when the lesson is going to be taught, and how it is going to be presented. When family members coach patients, the why is that as the primary caregivers, a family member will have to take over supervision of the patient’s home exercise plan once the patient leaves the hospital and help the patient remember to do the exercises. The when begins when the family member attends group physical therapy classes with the patient and learns instructions about the exercises from the physical

258

 Turning PAGES With Health Coaching and Family Involvement

therapist. And the how happens when family members offer encouragement and support to become an extra member on the team that helps motivate the patient to achieve success. To be successful, a curriculum also needs to incorporate goal setting. Beane (1997) explains, “curriculum integration centers the curriculum on life itself rather than on the mastery of fragmented information within the boundaries of subject areas. It works off a view of learning as the continuous integration of new knowledge and experience so as to deepen and broaden our understanding of ourselves and our world” (p. 18). Curriculum integration encourages democratic education and active learning, where participants have ownership of the curriculum instead of having someone else tell it to them. The goals of a curriculum often evolve from evidence based practice, such as action research. Action research occurs when a teacher develops a new idea and tries it in a classroom setting. Or as Connelly and Clandinin (1988) explain, “action research is, therefore, a deliberate way of creating new situations and of telling the story of who we are” (p. 153). If an idea is implemented and succeeds, it often becomes adapted into the curriculum. While action research has its foundation in the field of education, it can be modified for use in other fields. Part of health coaching involves encouraging people to set goals to take ownership of their healing. In this instance, the goal setting process becomes collaborative. A curriculum that provides the foundation of effective information that sets people up for success enhances the goal setting process. Clandinin and Connelly (2000) elaborate, “the teacher is part of the curriculum and therefore part of the establishment of the goals in the first place and part of the ensuing achievement” (p. 29). Just as teachers celebrate their students’ successes in a classroom, physical therapists celebrate their patients’ successes in a clinic. The creation of SMART (specific, measurable, action oriented, realistic, timed) goals in both settings means that learning becomes a collaborative team effort, with the successful outcome of one goal leading to the setting of a new goal. Connelly and Clandinin (1988) continue, “administering the curriculum meant the narrative living out of a personal philosophy of education” (p. 196). The best teachers combine the artistic and technical when teaching. They teach the required elements of the curriculum using methods that make the lessons come alive for students. The execution of an effective lesson resembles a beautiful figure skating or dance routine. Skaters and dancers must complete required technical elements, but also infuse their performance with artistic interpretation and passion. Physical therapists or physical therapy assistants who will teach the group therapy classes at the hospital spent time planning and designing a class that will be beneficial for patients as well as family members. Since the physical therapists enjoy creating exercise plans that will help patients, the new classes that will take place will enable patients to simultaneously learn while having fun. The physical therapists did come together utilizing the most recent evidence-based research and staying within every surgeon’s protocol to come up with the exercises for group classes. The group classes allow for a continuity of care for all patients which not only increases productivity but also allows for a more positive atmosphere. If a patient is having a hard time during the exercises he or she may get motivated by another patient coaching him or her on to success. It makes the patients feel like they are more of a team for recovery rather than having to do it on their own. Graves (2001) states, “the energy of the curriculum lies in the making, learning, and planning of what is ahead” (p. 49). If energy is put into the curriculum design and lesson plans, the energy will be reflected in the teacher as the lesson is taught and the students will subsequently benefit from it. Sometimes, however, the curriculum is not explicitly stated but implicitly implied. This is called the hidden curriculum. As Connelly and Clandinin (1988) define, “generally speaking, people think of the hidden curriculum as falling in the area of attitudes and values” (p. 154). In a classroom or physical therapy clinic, the hidden curriculum can encompass everything from the posters hanging on the walls to the smiles on the instructors’ faces. Patients also bring their own hid259

 Turning PAGES With Health Coaching and Family Involvement

den curriculum to their treatment sessions. A patient may not want to complete exercises as part of a treatment plan, but may want to achieve the goal of being pain free for a vacation. Health coaches can build bridges to link the information in the patient’s mind to illuminate the fact that doing the exercises will lead to a pain free vacation. Health coaches can also enlist the support of family members to offer additional encouragement during the healing journey. Every curriculum also needs a solid theoretical foundation to support the practice of teaching. The next sections highlight the dimensions of PAGES and why they are important for patients and family members. The primary audience for the explanation of the dimensions of PAGES is family members of hospital patients, but physical therapists, health coaches, other medical practitioners, and readers interested in learning something new can all benefit from the following information.

Practice Patience Healing is a journey. No one can wave a magic wand and provide an immediate cure. Celebrate progress, no matter how small. In children’s stories, a fairy godmother frequently shows up to save the day. There is a literary term for this too, called “Deus ex machina,” Latin for God from a machine, meaning unexpected rescue. It can be seen a lot in superhero stories too, when characters are rescued from a seemingly impossible situation. Real life doesn’t work that way, and people must do the work to reach their goals. Having a positive attitude can help make everything easier. Tindle (2013) believes that if one person has a positive attitude it can influence an entire community because, “when we learn to see the interconnectedness of things in this way, we understand how a positive attitude in one person can benefit countless others, because every person who is able to look up to mental and physical health gives herself maximal opportunity to develop her unique talents. Whenever even one of us can accomplish this feat, it not only stokes the enthusiasm of the entire group but also adds to our collective resources. To this end, cultivating a healthy outlook may perhaps be society’s ultimate return on investment” (p. 218). Therefore, if everyone involved in the patient’s healing journey, such as doctors, nurses, physical therapists, health coaches, and family members, promotes positivity the patient will know it is okay to take the time needed to heal. Promoting positivity can help patients not only emotionally, but also physically. Rankin (2013) discusses the connection between mind and body and asks, “so what happens to the body when the mind is in a dark place? Emotional suffering might start in the mind, but it is ultimately an embodied experience. You don’t just experience unhappiness in your mind. You feel it in your body, as suffering cascades through your body via the stress response” (p. 132-133). If a patient feels upset about the length of time it is taking to heal, it is possible that the emotional stress will manifest itself as additional physical symptoms. Studies show that a positive outlook leads to greater healing gains. Younger, Gandhi, Hubbard, and Mackey (2012) studied the positive or negative expectations patients had in physical therapy with the SETS (Stanford Expectations of Treatment Scale) and learned patients with a more positive expectancy did better than patients with negative expectancy (p. 767). Our own research led to the design of a new survey, The Wanner Bird Healing Survey for Pain Recovery (2013) and the conclusion that patients in a physical therapy clinic who used more positive language when responding to short writing prompts performed better on existing objective physical therapy measures. In order to have a positive attitude, patients need to feel they are in a safe environment. It takes time and patience to establish trust. Even though she writes about students in her classroom instead of patients in a physical therapy clinic, advice given by Johnson (1998) can apply to hospitals as well as schools 260

 Turning PAGES With Health Coaching and Family Involvement

because, as is true with anyone being taught, “they need time to see that we sincerely care about them, have something valuable to teach them, and will not embarrass them when they make mistakes. We need time to get to know their personalities and maturity levels, as well as their intellectual abilities and academic needs. It also takes time to create an environment in our classrooms that is comfortable and secure, so students can relax and concentrate on their lessons” (p. 101). Physical therapists collaborate with health coaches and family members to establish a supportive environment for the patient during group physical therapy classes.

Accept the Present Feelings of guilt, anger, and frustration are normal, but are not helpful when coaching. No matter what happened in the past, this is where you are now. Worrying about the future only causes additional stress. Try your best to remain in the present moment. Consider writing in a journal to sort through your feelings. When a loved one needs surgery and physical therapy, family members experience a myriad of emotions. They may feel anger at the circumstances that landed the patient in the hospital, or frustrated that the patient is not healing faster. They may feel guilty if their actions contributed to the patient’s condition or helpless because they can’t take away the pain. All of these feelings are normal, but do not help the patient. Therefore, it is important for family members to deal with their feelings by writing in a journal or talking to someone such as a supportive friend or professional counselor if additional help is needed. While writing in a journal can help patients heal, journals can also help family members sort through their feelings. Zimmermann (2002) explains, “there is now extensive research that shows writing – the simple act of putting down your deepest thoughts and feelings on paper – is one of the most powerful and effective means to ease and ultimately heal sorrow” (p. 18). Anyone visiting the English Department at a high school or college will most likely hear discussion of research studies illustrating how writing improves emotional health. Writing helps caregivers process their emotions so they can better help their family members who are patients. Caregivers can choose to keep their writing to themselves or share it with a health coach or other professional if they need to discuss their feelings. Health coaching meets people where they are in the present moment. Health coaches can help family members who are assistant coaches accept that they cannot change the past, so they must work with the patient in the present situation to set goals for the future. Health coaches can help a patient see the importance of a treatment plan and increase the patient’s confidence in completing the treatment plan by connecting the treatment plan to the patient’s vision and values. Pipher (2006) explains, “in both therapy and writing, we want to help people see the connections between their actions and consequences of those actions” (p. 97). It is also important for family members to realize they cannot force change on their loved one. In order for a person to make a change, he or she needs to reach the conclusion that change is necessary. Pipher continues, “people do not change unless they have a powerful emotional turning. This may be thorough epiphanies, insights, or deep connecting moments between the people in the room” (p. 100). While one person cannot make another change, showing acceptance and being a supportive presence can set the stage for powerful insights by the patient to occur. Another part of the health coaching process is accountability. Health coaches work with people to set goals and make connections, but they also ask the people they are coaching to be accountable for their actions. With family members, sometimes emotions get in the way when trying to hold a loved one accountable for his or her actions. As Brown (2010) explains, “it’s hard for us to understand that 261

 Turning PAGES With Health Coaching and Family Involvement

we can be compassionate and accepting while we hold people accountable for their behaviors” (p. 18). Sometimes when coaching a family member, emotions take over when the patient is not demonstrating accountability for complying with the treatment plan. Since health coaches have an objective distance from the patient that family members do not, health coaches can remind family coaches to continue to show compassion and acceptance during the patient’s healing journey. With family relationships, dynamics can get complicated. Beck (2008) elaborates, “you may be one of the lucky people whose loved ones and associates are all delighted and inspired when you set out to live your right life. More likely, though, you’ll encounter some level of resistance. After all, the most common reason we stray from our best lives is that we’re socialized to behave in ways that aren’t right for us. Our social groups, almost by definition, tend to disapprove when we drop those behaviors” (p. 191). Regardless of what has happened between family members in the past, it is important for family members to put any issues aside when coaching the patient. If the family member has felt disappointed in the patient’s behavior in the past, bringing those emotions into a group physical therapy class does not help the patient heal in the present moment. Change can be difficult for everyone, especially family members who did not ask for their lives to be disrupted by the patient’s surgery. However, as Nick tells Gatsby in The Great Gatsby by Fitzgerald (1925), “you can’t repeat the past” (p. 116). This quote from literature is powerful advice for families too. In addition to family members demonstrating acceptance for the patient’s current medical reality, the patient has to accept that even when the family is accepting and supportive, the patient still has to do the work to reach his or her healing goals. Beck (2001) states, ”people whose families were accepting and supportive have to face the fact that familial love can’t take them all the way to their right lives” (p. 70). Beck continues with the reminder, ”but you will still have to do the physical therapy to get your bones and muscles to work again. The same thing is true of psychological wounds” (p. 70). No matter how many people are cheering in the audience, the patient still needs to stand on the metaphorical stage of the physical therapy clinic and perform the exercises.

Gather Information The medical professionals such as doctors, physical therapists, occupational therapists, nurses, and speech therapists are here to help you. Ask questions, and listen to their instructions. Consider bringing a notebook with you to write down information so you don’t have to remember it. The more information a patient knows, the more empowered he or she feels while on the healing journey. Family members can help the patient by being another person to listen to the advice and instructions given by the medical professionals treating the patient. Medical professionals such as physical therapists want the patient to succeed and will provide helpful suggestions for how to complete the treatment intervention and make lifestyle adjustments during the healing process. By continuing to be a supportive presence, family members can make this gathering of information a team effort to ensure the comprehension of all information. Sometimes when patients are in pain they have a hard time remembering important information given to them by the therapist or information they want to share with the therapist. Family members can help make sure patients fully understand the important information once they get home or ask the important questions to the therapist. Knowing a patient’s initial thoughts about factors causing pain can assist clinicians in developing a treatment plan. Juhan (1998) explains, “this missing link of conscious, active engagement is of enormous importance when it comes to strategies of therapeutic intervention. 262

 Turning PAGES With Health Coaching and Family Involvement

Some of the habits I am unconsciously perpetuating are reinforcing – sometimes even creating – my current difficulties” (p. 350). Writing can illuminate such habits for both the patient and the clinician so ineffective old habits can be replaced by effective new ones. Family members can use journals to record information stated by the clinician so it is remembered, and patients can use journals to track their pain. By doing this, patients can provide an additional dimension of information for the clinician, and family members can make sure they have all information correctly written down for when the patient arrives home. Barrett (2013) writes about her own experiences with chronic pain and describes, “I started to track my experience with just pen and paper. I recorded when I felt best (and worst) and began making deliberate changes to my environment and behavior. One at a time, I assessed the factors in my life” (p. 37). Not all patients demonstrate the same initiative Barrett did in writing about pain, so writing prompts and surveys such as The Wanner-Bird Healing Survey for Pain Recovery assist patients in writing their thoughts. But asking a patient to write becomes only half the story. The other half involves a supportive clinician willing to read the writing. Rasminsky (2012) tells the story of Dr. Rita Charon, “the founding director of the Program in Narrative Medicine at Columbia University, where future MDs participate in writing workshops and examine texts by authors” (p. 88). Charon uses information about writing and literature typically found in an English teacher’s classroom to inform her practice because she “realized that the clues she needed weren’t confined to lab results and diagnostic scans. They were hidden in her patients’ habits, fears, beliefs, family circumstances, even their insurance battles” (p. 88). Writing can provide subjective qualitative information often missing in quantitative objective measures.

Encourage During the healing journey, patients need cheerleaders. You are a source of hope and light during this process and a little support can make a large difference. If patients know their loved ones will walk with them on their healing journey and be a source of comfort and support, they know they are not alone and part of a supportive community while they heal. If a patient is completing a set of exercises and looks across the room to see a health coach or family member offering words of encouragement, the patient will most likely experience increased motivation to comply with the treatment plan. By celebrating accomplishments and providing the reassurance that mistakes and setbacks are part of the healing journey, the best possible environment can be created for the patient. No one needs to be alone while on a healing journey. Graves (2001) believes, “emotional and intellectual isolation is terribly draining. We have to make the energy investment ourselves to improve the emotional climate around us. A strong collegial relationship is too important personally and professionally for us to wait for others to come to us. Rather, we have to initiate contact with others because of its energy-giving possibilities. The more we take risks and learn from each other, the greater the energygiving satisfaction. Ultimately, we see beyond our own limited collegial relationship to the possibilities of an energy-given vision we can fulfill together” (p. 68). Everyone can feel more energized about a treatment plan if all the clinicians and caregivers collaborate in a climate of care to help patients heal. Helldorfer and Moss (2007) discuss the importance of a climate of care because “while our focus at work is always on our patients, we are also part of a larger community of colleagues where we care for one another, and where each person has a role to play in creating the climate” (p. 163). A climate where patients feel encouraged to achieve their goals can make a positive difference in healing.

263

 Turning PAGES With Health Coaching and Family Involvement

Some communities, such as the schools children attend or the neighborhoods where families live, become permanent fixtures in people’s lives. Other communities, such as the hospital community where patients spend only a few days, are temporary. Nevertheless, a supportive community of any kind, even if it is for a short amount of time, can make a lasting impact. If a patient attends a group physical therapy class to learn exercises from the physical therapist, discuss goals with the health coach, and receive encouragement from a family member who is an assistant coach, it can make the patient feel accepted. Even talking with other patients who are experiencing similar health issues can create a sense of community and belonging. Brown (2012) explains that people need to feel unconditional belonging and elaborates, “what makes that such a challenge is that most of us struggle to feel a sense of belonging – to know that we are part of something, not despite our vulnerabilities, but because of them” (p. 233). When a patient is in a hospital room after surgery, it becomes easy to feel vulnerable. A strong community that makes the patient feel part of something greater than oneself can provide encouragement for the patient. It becomes essential for patients to feel part of a community as they heal because loneliness can lead to additional stress. Rankin (2013) discovered, “the reality is that loneliness causes stress, while loving community relaxes you. The effects of stress and relaxation don’t just affect the mind; they affect the body. When you lack supportive community and feel you must handle life alone, the daily overwhelm may trigger anxiety, which the brain perceives as a threat” (p. 86). Additional stress can influence the body’s ability to heal, so it becomes important to counteract the stress response with the relaxation found in an encouraging community. As part of her popular Lean In movement discussed in her book of the same title, Sandberg (2013) encourages people to create their own Lean In Circles to provide a network of colleagues for each other to share ideas, since ”communication works best when we combine appropriateness with authenticity, finding that sweet spot where opinions are not brutally honest but delicately honest” (p. 78). A Lean In Circle can easily be created in a hospital where patients can talk to each other and learn from each other. The patients’ families can also become part of the circle by offering encouragement to each other. If one family is having a difficult day, another family who has gone through a similar experience can be there to provide support as stories are shared. Baldwin (1998) discusses the value of calling a circle because “calling a circle doesn’t have to be a huge risk or lengthy experiment. We can start small, start with one evening” (p. 14). Patients sitting in a circle sharing their stories with a health coach during a group coaching session or families sitting in a circle leaning on each other and learning from each other can become a method to lean in and start a conversation. Through their encouragement of a patient going through treatment, family members become healers. Physical therapists, health coaches, and other clinicians are drawn to healing professions because of a desire to help others. Beck (2012) describes the healers as, “every now and again, though, I’ve met individuals who seem to embody the whole premise of the healer’s archetype. These people are walking generators of peace, hope, compassion, and restoration. The things they accomplish often seem miraculous, but they themselves are universally humble, insisting that their work is simple and pragmatic” (p. xxi). Family members who act as assistant coaches can join the team and also become a source of peace, hope, compassion, and restoration for the patient.

Self-Care In order to take care of your loved one, take care of yourself too. You can better help someone else when your own needs, such as hunger and sleep, are met too. 264

 Turning PAGES With Health Coaching and Family Involvement

Most people want to help others before they help themselves. However, taking care of someone else to the point where one’s own needs are neglected is not healthy. There is a reason that airlines give the speech about in the event of an emergency, put on your own mask before helping others with theirs. If the caregiver collapses from exhaustion, there is no one to help the patient. One way to practice self-care is to engage in mindful awareness. Tindle (2013) defines, “mindfulness is simply choosing to be aware of whatever you are thinking, feeling, and sensing right now” (p. 105). Being the caregiver for a loved one can cause stress and lead to burnout. Mindfulness means providing permission to not have to do anything for anyone for awhile and just be with one’s own thoughts and feelings in the present moment. Mindfulness means simply closing your eyes for a few minutes in meditation, or practicing a more formal meditation such as a Mindfulness Based Stress Reduction (MBSR) workshop or yoga class. Kabat-Zinn (2013), one of the leading experts in the field, shares the advice, “learning how to suspend all your doing and shift over to a being mode, how to make time for yourself, how to slow down and nurture calmness and self-acceptance in yourself, learning to observe what your mind is up to from moment to moment, how to watch your thoughts and how to let go of them without getting caught up and driven by them, how to make room for new ways of seeing old problems and for perceiving the interconnectedness of things – these are some of the lessons of mindfulness” (p. 6). Reading these words cannot take the place of a yoga class or MBSR class taught by an experienced instructor, so consider taking classes in your community if you want more formal mindfulness training than just closing your eyes to meditate. When experiencing stress from caregiving, relaxation time becomes essential for the caregiver to maintain his or her own health. Rankin (2013) suggests “other relaxing activities such as laughter, playing with pets, journaling, prayer, napping, yoga, getting a massage, reading, singing, playing a musical instrument, gardening, cooking, tai chi, going for a walk, taking a hot bath, and enjoying nature may also activate your parasympathetic nervous system and allow the body to return to a state of rest so it can go about the business of self-repair” (p. 153). Another resource can be writing in a journal. Baldwin (2006) describes how journals provide a record of our lives because “each journal’s contents are eclectic: reports of the day’s events, recorded feelings, dreams, dialogues, fantasies, sketches, recipes, quotes from current reading material, cartoons and clippings, photographs and four-leaf clovers – whatever writers want to leave recorded in their passage through time” (p. 5). Journals provide a resource to share any emotions experienced during an emotional day of caregiving. If you need additional resources for caregivers, visit websites such as Caregiver.com (2015) that have current articles, places to find support groups in your community, and other helpful information.

Teaching Lessons Typically teachers don’t set up their classrooms in a hospital but in a school, yet the same theory applies. Brady and Vega (2009) believe, “the best way to learn is to teach” (p. 128). However, as Brady and Vega observe, “most places lack a teaching and learning culture, because no one has organized it” (p. 128). The hospital will have the teaching and learning culture because it has organized group physical therapy classes for patients. Patients in the hospital will receive the same powerful learning moments as students in a classroom due to the effective educators who will teach them. Gruwell (2009) describes such learning moments as “those priceless moments when students’ faces lit up, their hands flew in the air, and I knew they ‘got it,’ validated all the sleepless nights and began to ease my self-doubt” (p. xix). All the effort becomes worth it when the teacher, whether it is a college 265

 Turning PAGES With Health Coaching and Family Involvement

writing professor demonstrating the craft of revision or a physical therapist demonstrating a series of exercises, makes a connection to the subject area in such a way that the students grasp the concept. The group physical therapy classes will be effective because they use modeling. As Johnson (2005) explains, “modeling is one of the most effective ways to teach new skills” (p. 169). When a patient sees the physical therapist or physical therapist assistant demonstrating exercises, the patient is more likely to remember the concept. Another effective educational component of the group physical therapy classes is using family members as assistant coaches. Johnson continues, “teachers tend to be nurturing souls. We like to help other people. But we also like to be in control, and many of us find it difficult to delegate any of our authority. Sharing your authority can provide huge dividends, however” (p. 95). Sharing authority with family members, especially since the family members will take over the supervision of the exercises when the patient returns home, makes everyone share the work and makes the patient’s healing journey a team effort. Granted, as every teacher who has ever stood in front of a group of students will share, teaching can be challenging. Graves (2001) believes, “yes, teaching is an emotional roller coaster because our business is the growth of human beings” (p. 149). But with modeling by an excellent physical therapist teacher, goal setting from a health coach, and support from family members, patients will experience powerful learning moments as they heal.

Healing Through Writing Writing has been mentioned several times in this narrative as a method for people to process their thoughts and feelings. As part of the family coaching program, health coaches can lead group coaching sessions and writing workshops for either patients or their family members. While a circle sharing session may look like group therapy, it is important to remember that group health coaching and writing workshops are not group therapy. Instead of focusing on past issues like group therapy, group coaching focuses on meeting the needs of people where they are in the present and finding strategies to help them move forward. Because I (Jen) am also a writing professor, as part of my health coaching I also use my writing training and credentials to help people. Other health coaches have different backgrounds that they may choose to incorporate into their coaching. Sometimes people experience stress when they find themselves struggling to focus on the myriad of thoughts occupying their minds. Goldberg (2000) reports, “we don’t own our thoughts, even if they are filled with all our own details. They come through us, like heartbeat and breath” (p. 30). And the more thoughts come through, the more overwhelmed a person can feel. Expressive writing helps control the chaos. Romano (2000) discusses the value of expressive writing and elaborates, “when we write expressively in a journal, we imprint ideas, information, and experience deeply within us. We live topics by re-creating them with words on paper, by pulling images and dialog from the flow of our lives” (p. 138). And expressive writing is often best completed when an individual has time to reflect. Pennebaker and Evans (2014) concur, “expressive writing can force you to deal with important emotional experiences that you may have been avoiding” (p. 27). No matter the age of a person, whether teenager or senior citizen, writing helps the author articulate emotional experiences so physical and emotional healing can begin. And no one has to read the writing or grade it. I (Jen), an English professor, sent my students on a writing field trip as part of class this semester. They had to pick a location of their choice and write about a topic of their choice. I never asked them to share their writing with me; their only assignment was to send me an email telling how the experience 266

 Turning PAGES With Health Coaching and Family Involvement

made them feel. This assignment was part of my normal classroom practices and not part of any research study, but a summary of student comments provides the insight that writing felt peaceful and therapeutic for the college students who participated in the activity. Murray (1996) believes, “writers must learn to have faith in the writing act; they are led by the writing to discover what they have to say and how it may be said” (p. 25). During their writing time, my students discovered what they needed to say. Pennebaker (1997) conducted a significant study discussing the health benefits of writing and concludes, “as we have found in many of our studies, you may feel sad or depressed immediately after writing. These negative feelings usually dissipate within an hour or so. In rare cases, they may last a day or two. The overwhelming majority of our volunteers, however, report feelings of relief, happiness, and contentment soon after the writing studies are concluded” (p. 42). Pennebaker and Chung (2010) highlight concrete physical health benefits of Pennebaker’s research and elaborate, “writing or talking about emotional experiences relative to writing about superficial control topics has been found to be associated with significant drops in physician visits from before to after writing among relatively healthy samples” (p. 16). Therefore, research demonstrates that writing can heal people not only emotionally but also physically. Evans (2010) reports, “wellness and writing are connected in ways yet to be fully researched and exploited, but the literature of several disciplines declares that for many people wellness and writing are connected in ways useful for emotional, physical, and spiritual health” (p. 3). In a previous research study, Eric, his former professor Dr. Claudia Jayne Brahler, and Jen discovered that physical therapy patients who used a strong positive writing voice demonstrated increased healing gains on existing objective physical therapy measures. We plan to continue our research to discover additional influences of writing on emotional, physical, and spiritual healing.

Dialogue Journals One method the patient, family, physical therapist, and other medical practitioners can use writing as healing is through dialogue journals. Unlike a private journal intended to be seen by only the individual writing in it, a dialogue journal is meant to be a written conversation between two or more people. It looks like an email conversation, only on notebook paper. The value of writing conversations is that it gives both authors time to reflect on ideas. When working on a book chapter, Jen and Eric like to send each other emails with writing ideas. This type of idea exchange resembles a dialogue journal, however some patients may not feel comfortable using technology or be concerned that for various reasons, the emails they send are not private or confidential. If it is not possible to exchange emails, patients and family members can write their questions in a notebook so they do not forget them. The physical therapist or other medical practitioner can use the questions and any other observations to modify the treatment plan if necessary. The patient could benefit from writing down their questions between treatment sessions so they don’t forget what they what to ask once the therapist arrives. Vacca, Vacca, and Mraz (2014) provide the definition, “as is the case with response and double-entry journals, students keep an ongoing record of learning as it happens in a notebook” (p. 299). Patients are therefore able to track their learning as it takes place so the physical therapist has a record of progress and family members have a record of insights to help them care for their loved one. As Romano (1987) writes, “readers peer into the writer’s very soul” (p. 41). Some people express themselves better in writing instead of speaking. Dialogue journals open the door for such conversations. Sometimes people don’t want to share their writing because it makes them feel vulnerable. NoppeBrandon (2004) asked her students if they liked to read and write and observed, “among those who raised 267

 Turning PAGES With Health Coaching and Family Involvement

their hands, few chose to read or write, they simply didn’t mind it. As a formerly voiceless person, who had channeled many of my own thoughts and feelings into private writing, I couldn’t totally understand this. It was only as I closed the gap between my private and public expressions that I began to fully appreciate the vulnerablility involved in revealing things, even to oneself” (p. 2). Reflecting on thoughts and feelings means being vulnerable. The script in a person‘s head may read: What if someone doesn’t like the real me? What if I don’t like the real me? But during the healing process, the patient needs to trust that a physical therapist is used to discussing sensitive medical information and a health coach can help the patient deal with any difficult family dynamics as well as work with the family to develop a supportive environment. Such support can lead everyone on the patient’s care team to exchange ideas in writing. Barbieri (1995) describes the writing process as, “words came onto the page that I had not intended; the whole point of what I had been trying to say became clear to me, and I knew what I needed to write next. Stunned, I thought I had discovered magic” (p. 16). When it leads to discovery, writing does seem like magic. Kearns (1997) counters, “good writing is not the result of a magic wand; it comes from hard work” (p. 16). But when that hard work falls into place it looks effortless, like magic. And teachers, whether they are in a school or physical therapy clinic, can help the magic happen. Cleary (1991) believes, “we need our writing curriculum to reattach students to their souls” (p. 167). In the next section, the PAGES family coaching program is reflected through the lens of writing, as lessons from the writing curriculum are applied to help physical therapy patients. Writing workshops and group coaching are not required for the PAGES program, but will add another dimension to it.

PRACTICING PATIENCE: TRUSTING FIRST IMPRESSIONS As wonderful as technology can be, it can also create stress. It is not uncommon to see a family out to dinner at a restaurant and everyone is looking at their phones instead of each other. Sometimes we need to remind ourselves to calm down and slow down, especially when there is a need to heal physically and emotionally. Both patients and family members can use writing to center themselves while demonstrating patience with the healing process. A journal can provide a private place to explore feelings about relationships, including the relationship with oneself. But in order to write honestly, the writer has to ignore the self-censor and write from the heart. Cameron (1998) explains, “acting our way into right thinking is putting pen to the page even when the censor is shrieking” (p. 35). This means writing whatever comes to mind and trusting first thoughts and impressions before censoring anything written out of worry of what anyone else might think. Goldberg (1986) answers the question, “why else are first thoughts so energizing? Because they have to do with freshness and inspiration” (p. 10). Frequently writers ignore first thoughts because they fear what others may think if the writing is read. But not all writing needs to be for an audience. Students in an English classroom become used to writing essays, turning them in for a grade from the teacher, and being evaluated. However, teachers also need to give students time to write in journals without requiring students to share the writing. Romano (2004) elaborates, “students need to pay attention to their deep feeling and thinking. They will waste less time if they put aside the tangential, focus on what needs to be written, and respect the words tearing through the brain. They need to respond to their emotions. They need to move on the images flashing in their minds” (p. 49). The same philosophy

268

 Turning PAGES With Health Coaching and Family Involvement

that applies to students completing journals in an English classroom also applies to patients completing journals in a hospital. For people to write what needs to be written, they need to trust that all writing does not have to be read, that there is a time to share but also a time to write for one’s eyes only. Therefore, the journal becomes an effective method for practicing patience because a notebook page doesn’t talk back or judge the author. Sharp (2000) provides the advice, “whatever it takes, don’t think, don’t second-guess, don’t edit. This exercise must come as directly as possible from your head to the page, traveling without censorship” (p. 18). Such advice reflects why numerous writing teachers believe first thoughts are the truest ones and the best method of capturing writing voice. Goldberg (2013) describes the moment of first thoughts as, “a flash, a moment appears when we fall through and what we are fighting, running from, struggling with becomes open, luminous – or, even better, not a problem, just what it is” (p. 23). And by not judging their words, writers can find the answers to life’s problems and practice patience while they arrive at the answers.

ACCEPTING THE PRESENT: FINDING VOICE THROUGH WRITING Just like everyone has a unique speaking voice, everyone has a unique writing voice. When a writer’s voice shines through in a composition, it is like the writer is in the room having a conversation with the speaker. Graves (1994) discusses voice in writing and elaborates, “the writing process has a driving force called voice. Technically, voice is not a process component or a step in the journey from choice-rehearsal to final revision. Rather, it underlies every part of the process.” (p. 81). Voice exists in the way a writer uses language. The tone of writing can capture mood even if the reader can’t see the writer’s facial expression. The way a writer writes a phrase can illustrate written expression and reflect a personality on paper. As Murray (1985) explains, “we respond to voice when we hear it. Voice gives the text individuality, energy, concern. Voice is, of course, closely allied to style or tone, but I prefer the term ‘voice’ for it seems more accurate and more helpful for the beginner” (p. 21). Just like people sometimes silence their speaking voices, they similarly silence their writing voices. But listening to one’s voice can lead to acceptance of the present moment. By not censoring ourselves, we illuminate what we truly need and want. We can start making plans for how to get to where we are in the present to where we want to be in the future. It can give patients and their family members hope that the present situation won’t always be the way it is now. Often writers ask themselves questions such as: What do I say? How do I say it? Heard (1995) encourages writers to speak and shares, “as I walk, I write. Words circle my head. I speak lines out loud to see how they’ll sound” (p. 32). Sometimes writing happens in the mind before a writer ever puts pen to paper or fingers to computer keyboard. This prewriting process, often called percolating to capture the image of an idea brewing just like coffee before it can be shared, is valuable. Nevertheless, an idea will forever remain in the writer’s mind unless he or she finds the voice to speak it. Lamott (1994) advises writers, “you need to trust yourself, especially on a first draft, where amid the anxiety and self-doubt, there should be a real sense of your imagination” (p. 112). That self-trust is how we as writers find our voices. Our writing voices always remain with us; we just need to find the courage to share them. Teachers who give students a classroom that symbolizes a safe space for sharing provide a platform for voices to be heard. Romano (2004) reminds students, “voice will come. Voice will come when you heed passion, push forward with language, are brave on the page, everything else be damned” (p. 51).

269

 Turning PAGES With Health Coaching and Family Involvement

Teachers can encourage students to share their voices by reminding them they have something to say. Gruwell (1999) writes about her students, “although I’m not an expert on the subject, I’ve always felt that all kids learned to rebel. Understanding this rebellious nature, I encouraged the Freedom Writers to use a pen as a means of revolution” (p. 276). Gruwell and her students published a book sharing their writing and provided inspiration to others who wanted to use writing as a catalyst for change in their lives.

GATHERING INFORMATION: TEACHERS SET THE TONE While anyone, regardless of age, always has the option of picking up a pen and a blank notebook, students need guidance from their teachers, whether that teacher is in the writing classroom sharing a new writing prompt or the physical therapy clinic sharing a new exercise. Romano (1987) explains, “the teacher is the first and most convincing example of the kind of behavior she wants in her class. She writes honestly, she shares what she’s written, she listens to the writing of her students and respects their voices and visions” (p. 43). An English teacher who is willing to share his or her own writing with students sets the tone for a comfortable class community where students feel encouraged to explore their own ideas through writing. Similarly, a physical therapist who is willing to model exercises for a patient sets the tone for a comfortable learning environment where patients feel encouraged to complete their exercises. Writing teachers who don’t write are like swimming teachers who never jump into the pool; why should teenagers take them seriously? So when teaching a writing workshop for students, patients, or family members, teachers need to view themselves as writers. As Atwell (1987) argues, “teachers do not require student writers to do anything they don’t do themselves as writers. They draw on their personal knowledge of writing when conferring with students” (p. 283). Kearns (1997) concurs, “students do not see teachers write enough. They see us talking, reading, viewing, reprimanding, ordering, conferencing, and sometimes listening. They need to see us writing” (p. 83). When teachers share writing with their students, it does not mean sharing personal information that will make everyone in the room uncomfortable. It means providing information and modeling a strategy so information is gathered and learning can occur. This opens the door for students to feel more confident sharing their own experiences in writing. As Gaughan (1997) explains, “sharing my struggles with writing helped create the atmosphere of trust students need to write honestly and subsequently boosted individual students’ confidence” (p. 7). Too often, students feel the pressure to be perfect in school. Cleary (1991) describes this perfectionism as “students became good-grade junkies, and as they began to work for teachers, they stopped writing for themselves” (p. 67). When teachers become willing to model their writing process, with all the revisions, edits, and drafts, students learn to see writing as a process and a journey with all the risks and rewards that come with it. Patients often feel the same way when attending physical therapy sessions. They want to impress the physical therapist with their hard work. They want the physical therapist to like them and see them as model students. But everyone is entitled to a bad day and setbacks happen. Modeling can reframe setbacks as part of the learning process, not a catastrophic event. Hubbard (1996) elaborates, “when teachers write and share how they write with their students, they are able to provide more than the overt activities that make up the skill of writing – they can share their own inner processes as well” (p. 47). Gathering information means trusting the process. It means empowering the patient to set goals for himself or herself, which means the goals will be more likely to be achieved when the patient takes ownership of them instead of completing a treatment plan just to make family members or the physical 270

 Turning PAGES With Health Coaching and Family Involvement

therapist happy. Connelly and Clandinin (1988) believe, “life’s narratives are the context for making meaning of school situations” (p. 27). We think of learning as taking place in schools, but learning also takes place in hospital classrooms as well as the classroom of life.

ENCOURAGEMENT: WRITING WITH PASSION Most people can relate to the feeling of being completely absorbed in an activity and getting into the zone where time fades away. Writing helps illuminate what the writer values. Illuminating values can lead to encouragement; health coaches consistently connect a patient’s goals to vision and values in order for people to see connections to the goals in their lives and feel excited about achieving them. Romano (2013) explains, “to capture stream of consciousness, the writer has to let go of control more than usual, trust the gush of language and associations even more” (p. 117). If people trust the gush of feeling and become willing to write about things that bring joy, they start on the path to feeling encouraged to find their passion in life. And discovering passion leads to purpose, especially if a patient’s family provides support and encouragement as a patient sets new goals and finds new passions. Since it takes time for a patient to heal after surgery, patients may need to put old passions on pause and discover new ones. A journal serves as a mirror reflecting goals accomplished, which encourages the patient to persevere while recovering. Pipher (2006) elaborates, “by diving into the experience of writing, you will learn what you truly think and who you really are” (p. 44). Sometimes people struggle to figure out who they are, especially if a surgery creates chaos in a once stable life. Writing can bring you back to yourself and remind you who you are. Romano (1995) describes seeing students find their passion and writes, “in my experience, passion in students has usually led to strong positions, critical thinking, further analysis, and stirring, often eloquent language” (p. 25). One way to find what will bring passion in the future is to remember what brought passion in the past. According to Goldberg (2007), “writing is your practice as you mow through your memories, the even chord among the highs and lows” (p. 70). Memories of past successes and remembering a time when happiness happened often sets the stage for future dreams. Intuitively, we all know what we want to do with the one life each of us has been given, but the challenging part becomes following our hearts no matter what others think. Lamott (1994) reminds us to recapture our true desires because “you get your intuition back when you make space for it, when you stop the chattering of the rational mind” (p. 112). Writing can help process feelings and goals; a phrase on paper can make the impossible seem possible if it is broken down into steps. Goldberg (1990) describes a strategy for articulating goals and feelings and advises, “a helpful technique: right in the middle of saying nothing, right in the middle of a sentence, put a dash and write, ‘What I really want to say is…’ and go on writing” (p. 73). We say what we need to say. We keep writing. We keep living. We welcome the encouragement from others as we set our goals and find the strength to encourage ourselves.

SELF-CARE: THE PERFECT PROCESS OF IMPERFECT WRITING When a writer needs to say something, the best advice is for writing to light the way. As Heard (1995) observes when struggling with a piece of writing, “I had changed the intent of the writing, just as people move a stream by redirecting its banks, hoping the water will obey. It never does. Neither did my writing” 271

 Turning PAGES With Health Coaching and Family Involvement

(p. 41). A writer should not feel confined to any specific form; writing can appear as a poem, recipe, song, essay, or other creative genre depending on the writer’s mood and topic. As Gaughan (2001) observes, “multiple genres act as multiple lenses” (p. 21). With writing, the journey becomes more important than the destination. Regardless of the genres we write, writing provides a moment for self-care and a reason to give a few moments to oneself. This is especially important for caregivers giving time to others. We are all the experts of our own lives, and no one can tell our story in the exact same way we can. Vinz (1996) discusses the value of narratives and explains, “when past and present were considered as dimensions of the whole experience, these teachers authored new stories that transgressed particular moments, beliefs, or actions” (p. 92). Each person authors his or her story, regardless if they are a student in a classroom at school, a student in a group physical therapy class, or a student in the classroom of life. An author may choose for a story to remain private or choose to share it. By sharing our stories with each other, we all become teachers and students of each other’s narratives of experience. Writing doesn’t have a right answer, like 2+2=4. We write to find the right answers. Romano (2008) believes, “but I am a teacher. I know that the path toward accomplishment can be a zigzag one, replete with setbacks, wrong turns, and backtracking. That’s why I value approximation so much: the flawed attempt, the good intentions gone awry, the achievement of approximately what you were after. For those who participate in good faith, learning is a matter of growth and development” (p. 206). We have faith in the fact writing helps us learn and grow. Writing reminds us to practice self-care.

WRITING THE NEXT CHAPTER IN THE HEALING JOURNEY For the reasons stated previously in the discussion of writing theory, the practice of writing can enhance a group coaching class. A group coaching class provides structure for people. Students in a classroom receive advice from teachers like Rief (1992) who instruct, “we take at least thirty minutes each Monday for silent writing. I begin my writing with the students during this time” (p. 30). A group class provides accountability and structure for hospital patients and their families. Patients at the hospital will attend a group therapy class where family members will also be able to participate. After attending a group physical therapy class or occupational therapy class, attending a group coaching class with writing activities can become another part of the patient’s schedule. Murray (1996) writes, “we forge communities when we share who we are, what we feel, what we think; and writing allows a sharing beyond the room, even beyond our lifetime” (p. 7). After participating in discussion as part of the community, patients will then be encouraged to write their goals for the next day. The written goals can be displayed in a location of the patient’s hospital room and later the patient’s home to provide a visual reminder of goals. Patients can also celebrate any successes and vent any frustrations through writing. As Johnson (2005) advises her students, “say whatever you want. Then rip up the paper into tiny shreds and throw it away” (p. 263). Patients can rip up writing if it helps them vent frustrations or save their writing as a powerful reminder of celebrating success. And know that regardless of what happened today, tomorrow is another day. Combined with the writing activities, a health coach conducts a group coaching session where patients and family members can celebrate successes and vent frustrations together. As Clark (2003) reminds teachers, “kids want to know you care for them. Before they are willing to invest effort in what you are saying, they want to know you are willing to make an investment in them” (p. 168). A group coaching class led by a health coach provides an environment where patients and their families know that they are cared for and supported. Group coaching enables people to walk through their healing journeys to272

 Turning PAGES With Health Coaching and Family Involvement

gether, empower patients, and provide families with the educational resources they need to assist physical therapists with exercises. Johnson (2011) thanks teachers “for believing in the life-changing power of education” (p. 3). Life-changing education can occur because the outstanding team at the hospital believes it is possible. PAGES was chosen as an acronym for this program because it symbolizes turning a new page in life. People turn pages of a book to get to the next chapter in the story, just as people can use the PAGES program to get to the next chapter of their own life stories. Unlike a book that has already been written, life represents a series of unwritten pages for the author to narrate and experience. Clandinin and Connelly (2000) describe the study of narratives, called narrative inquiry, as, “we characterized narrative inquiry as a kind of fluid inquiry, a kind of inquiry that challenges accepted inquiry and representation assumptions. It is a kind of inquiry that necessitates ongoing reflection, what we have called wakefulness” (p. 184). Wakefulness and reflection echo the mention of mindfulness earlier in this narrative, when healing can occur by practicing patience, accepting the present, gathering information, encouragement and self-care. We don’t know other people’s stories. We can, however, turn the PAGES to learn more.

REFERENCES Atwell, N. (1987). In the middle. Portsmouth, NH: Heinemann. Baldwin, C. (1998). Calling the circle. New York, NY: Bantam. Baldwin, C. (2006). One to one. Lanham, MD: Rowman and Littlefield. Barbieri, M. (1995). Sounds from the heart. Portsmouth, NH: Heinemann. Barrett, D. (2013). What is paintracking? Pain Pathways, 6(1), 36–41. Beane, J. A. (1997). Curriculum integration. New York, NY: Teachers College Press. Beck, M. (2001). Finding your own North Star. New York, NY: Three Rivers Press. Beck, M. (2008). Steering by starlight. New York, NY: Rodale. Beck, M. (2012). Finding your way in a wild new world. New York, NY: Free Press. Brady, L., & Vega, P. (2009). 5 keys to structural success. In M. K. Steele (Ed.), Orthopedics and spine (pp. 107-132). Danvers, MA: HCPro. Brown, B. (2010). The gifts of imperfection. Center City, MN: Hazelden. Brown, B. (2012). Daring greatly. New York, NY: Gotham Books. Cameron, J. (1998). The right to write. New York, NY: Tarcher/Putnam. Caregiver.com. Inc. (2015). Today’s caregiver. Caregiver.com. Retrieved from http://caregiver.com/ index.htm Clandinin, D. J., & Connelly, F. M. (2000). Narrative inquiry. San Francisco, CA: Jossey-Bass. Clark, R. (2003). The essential 55. New York, NY: Hyperion.

273

 Turning PAGES With Health Coaching and Family Involvement

Cleary, L. M. (1991). From the other side of the desk. Portsmouth, NH: Heinemann. Connelly, F. M., & Clandinin, D. J. (1988). Teachers as curriculum planners. New York, NY: Teachers College Press. Evans, J. (2010). Wellness and writing connections. Enumclaw, WA: Idyll Arbor. Fitzgerald, F. S. (1925). The great Gatsby. New York, NY: Scribner. Gaughan, J. (1997). Cultural reflections. Portsmouth, NH: Heinemann. Gaughan, J. (2001). Reinventing English. Portsmouth, NH: Heinemann. Goldberg, N. (1986). Writing down the bones. Boston, MA: Shambhala. Goldberg, N. (1990). Wild mind. New York, NY: Bantam. Goldberg, N. (2000). Thunder and lightning. New York, NY: Bantam. Goldberg, N. (2007). Old friend from far away. New York, NY: Free Press. Goldberg, N. (2013). The true secret of writing. New York, NY: Atria. Graves, D. H. (1994). A fresh look at writing. Portsmouth, NH: Heinemann. Graves, D. H. (2001). The energy to teach. Portsmouth, NH: Heinemann. Gruwell, E. (2009). Teaching hope. New York, NY: Broadway. Gruwell, E., & the The Freedom Writers. (1999). The Freedom Writers diary. New York, NY: Broadway. Heard, G. (1995). Writing toward home. Portsmouth, NH: Heinemann. Helldorfer, M., & Moss, T. (2007). Healing with heart. Orinda, CA: Moss Communications. Hubbard, R. S. (1996). A workshop of the possible. York, ME: Stenhouse. Johnson, L. (1998). Two parts textbook, one part love. New York, NY: Hyperion. Johnson, L. (2005). Teaching outside the box. San Francisco, CA: Jossey-Bass. Johnson, L. (2011). Teaching outside the box (2nd ed.). San Francisco, CA: Jossey-Bass. Jones, J., Brady, L., & Gaunt, R. (2009). The philosophy of patient-centric care. In M.K. Steele (Ed.), Orthopedics and spine (pp. 81-105). Danvers, MA: HCPro. Juhan, D. (1998). Job’s body (2nd ed.). Barrytown, NY: Station Hill. Kabat-Zinn, J. (2013). Full catastrophe living (2nd ed.). New York, NY: Bantam. Kearns, J. (1997). Where to begin: a guide to teaching secondary English. Portsmouth, NH: Heinemann. Lamott, A. (1994). Bird by bird. New York, NY: Anchor Books. Marshall, J. D., Sears, J. T., & Schubert, W. H. (2000). Turning points in curriculum. Upper Saddle River, NJ: Merrill/Prentice Hall.

274

 Turning PAGES With Health Coaching and Family Involvement

Murray, D. M. (1985). A writer teaches writing (2nd ed.). Boston, MA: Houghton Mifflin. Murray, D. M. (1996). Crafting a life. Portsmouth, NH: Heinemann. Noppe-Brandon, G. (2004). Find your voice. Portsmouth, NH: Heinemann. Pennebaker, J., & Chung, C. K. (2010). Expressive writing, emotional upheavals, and health. In J. Evans (Ed.), Wellness and writing connections (pp. 11–52). Enumclaw, WA: Idyll Arbor. Pennebaker, J. W. (1997). Opening up: the healing power of expressing emotions. New York, NY: The Guilford press. Pennebaker, J. W., & Evans, J. F. (2014). Expressive writing: words that heal. Enumclaw, WA: Idyll Arbor. Pipher, M. (2006). Writing to change the world. New York, NY: Riverhead. Rankin, L. (2013). Mind over medicine. Carlsbad, CA: Hay House. Rasminsky, A. (2012). The story doc. Oprah, 13(7), 88. Rief, L. (1992). Seeking diversity. Portsmouth, NH: Heinemann. Romano, T. (1987). Clearing the way. Portsmouth, NH: Heinemann. Romano, T. (1995). Writing with passion. Portsmouth, NH: Heinemann. Romano, T. (2000). Blending genre, altering style. Portsmouth, NH: Heinemann. Romano, T. (2004). Crafting authentic voice. Portsmouth, NH: Heinemann. Romano, T. (2008). Zigzag. Portsmouth, NH: Heinemann. Romano, T. (2013). Fearless writing. Portsmouth, NH: Heinemann. Ryan, N. P., Wade, J. C., Nice, A., Shenefelt, H., & Shepard, K. (1996). Physical therapists’ perceptions of family involvement in the rehabilitation process. Physiotherapy Research International, 1(3), 159–179. doi:10.1002/pri.56 PMID:9238732 Sandberg, S. (2013). Lean in. New York, NY: Alfred A. Knopf. Sharp, C. (2000). A writer’s workbook. New York, NY: St. Martin’s Press. Steele, M. K. (2009). Orthopedics and spine. Danvers, MA: HCPro. Tindle, H. (2013). UP: How positive outlook can transform our health and aging. New York, NY: Hudson Street Press. Vacca, R. T., Vacca, J. L., & Mraz, M. (2014). Content area reading (11th ed.). Boston, MA: Pearson. Vinz, R. (1996). Composing a teaching life. Portsmouth, NH: Heinemann. Wanner, E.T., & Bird, J.L. (2013). The Wanner Bird healing survey for pain recovery.

275

 Turning PAGES With Health Coaching and Family Involvement

Younger, J., Gandhi, V., Hubbard, E., & Mackey, S. (2012). Development of the Stanford expectations of treatment scale (SETS): A tool for measuring patient outcome expectancy in clinical trials. Clinical Trials, 9(6), 767–776. doi:10.1177/1740774512465064 PMID:23169874 Zimmermann, S. (2002). Writing to heal the soul. New York, NY: Three Rivers Press.

KEY TERMS AND DEFINITIONS Accept the Present: Feelings of guilt, anger, and frustration are normal, but are not helpful when coaching. No matter what happened in the past, this is where you are now. Worrying about the future only causes additional stress. Try your best to remain in the present moment. Consider writing in a journal to sort through your feelings. Encourage: During the healing journey, patients need cheerleaders. You are a source of hope and light during this process and a little support can make a large difference. Gather Information: The medical professionals such as doctors, physical therapists, occupational therapists, nurses, and speech therapists are here to help you. Ask questions, and listen to their instructions. Consider bringing a notebook with you to write down information so you don’t have to remember it. PAGES: An acronym for the terms described in this section. Practice Patience: Healing is a journey. No one can wave a magic wand and provide an immediate cure. Celebrate progress, no matter how small. Self-Care: In order to take care of your loved one, take care of yourself too. You can better help someone else when your own needs, such as hunger and sleep, are met too.

This research was previously published in the Handbook of Research on Advancing Health Education through Technology edited by Victor X. Wang, pages 213-233, copyright year 2016 by Medical Information Science Reference (an imprint of IGI Global).

276

277

Chapter 15

Knowledge Management for Health Care and Long-Term Care in the Technology-OrganizationEnvironment Context Man Fung Lo The Hong Kong Polytechnic University, Hong Kong Peggy Mei Lan Ng The Hong Kong Polytechnic University, Hong Kong

ABSTRACT The objective of this chapter is to propose a framework examining the impacts of technological, organizational and environmental factors on the innovation adoption of knowledge management (KM) in longterm care context. This chapter begins with the definition, rationale and importance of KM. Secondly, KM stories, KM in long-term care, prior frameworks in long-term care and knowledge barriers in health care settings will be reviewed. Furthermore, the KM for long-term care in Technology-OrganizationEnvironment (TOE) framework is discussed and proposed. The technology dimension includes security, complexity and costs. Besides, organizational dimension is composed of top management support, firm size, nursing leadership and the readiness. For environmental dimensions, this chapter will focus on competitive pressure and vendor support. As KM is proven to understand performance in long-term care organizations, the proposed framework provides insight to health care organization leaders on how to enhance the effectiveness of KM system.

INTRODUCTION Over the past ten years, more studies have shown that effective Knowledge Management (KM) improve the overall business performance (Choi et al., Fugate et al., 2009; Ho, 2008; 2008; Lee et al., 2012; Liao and Wu, 2009; Noruzy et al., 2013; Zack et al., 2009). Survival of any healthcare organizations heavily depends on KM, such as implementing evidence-based medicine in daily healthcare activities, retrieving DOI: 10.4018/978-1-5225-7122-3.ch015

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Knowledge Management for Health Care and Long-Term Care

evidence-based reports, and providing quality of care to patients by exchanging the knowledge among several partners of healthcare organizations. In fact, public health decision is evidence-based, which is mainly data-driven, and healthcare sector can be advantageous through the implementation of KM. KM in long-term care has focused exclusively on improving processes by incorporating KM practices. For example, employing digital dashboard can support touch-points in long-term care work flow by consolidating real-time information for users to view key performance indicators, making data much more useful for users. As mentioned by Pan & Jang (2008), Technology-Organization-Environment (TOE) framework was developed to study the adoption of technological innovations. This framework was widely adopted in many industries: information technology (Low, Chen, Wu, 2011), government (Pudjianto, Zo, Ciganek & Rho, 2011), auditing (Rosli, Yeow & Siew, 2012) and hospitality (Racherla & Hu, 2008). This chapter will overview KM, discuss the importance of KM in long-term care, KM stories and prior frameworks in long-term care, knowledge barriers and examine critical factors that enhance KM in long-term care using the TOE framework.

WHAT IS KNOWLEDGE MANAGEMENT? KM aims to make the right knowledge available to the right people at the right time so that the best possible strategies and outcomes can be delivered. The purpose of KM is to identify, create, transfer and apply knowledge to achieve better strategic objectives, resulting in enhancing organizational performance (Choi et al., 2008, López-Nicolás and Meroño-Cerdán, 2011). KM is concerned with innovation and sharing behaviors and improvement of capabilities through learning (Moustaghfir and Schiuma, 2013). In addition, KM assists in managing complexity and ambiguity through knowledge networks and connections, exploring smart processes and deploying appropriate tools and technologies (Bharati et al., 2015). There are several sub-strategies discussed in the literature within the domain of KM. Firstly, the concepts of exploitation and exploration are introduced by March (1991). Secondly, Hansen et al. (1999) compare and contrast two KM sub-strategies for a classic study in managing knowledge - codification and personalization. The former one is concerned about how knowledge is codified, stored and accessed through computerized databases; whereas the latter one refers to how knowledge is shared through direct contact among organizational members and/or with technology support (Hansen et al., 1999). Pourhamidi (2013) further contends that the characteristics of codification are similar to those defined in exploitation whilst those attributes in personalization are consistent with the concept of exploration. A broader perspective has been adopted by Choi and Lee (2003), who argue that there are system-oriented and human-oriented KM sub-strategies. The adoption of different KM strategies in recent literature is summarized in Table 1. Apart from the above-mentioned sub-strategies, there are several key models in KM domains. This section aims to provide an overview on these models. Firstly, Nonaka and Takeuchi (1995) have developed the knowledge spiral model which is composed of four quadrants: (1) socialization; (2) externalization; (3) combination; and (4) internalization (SECI). This model demonstrates how different forms of knowledge conversion occur. First, socialization refers to the tacit-to-tacit conversion. Moreover, combination takes place when pieces of explicit knowledge are synthesized or combined. Thirdly, tacit knowledge from one’s mind is converted to explicit form through externalization. When explicit knowledge is converted to tacit form, it is called internalization. Nonaka and Takeuchi (1995) have further pointed out that the sharing and conversion of knowledge is a continuous process and the knowledge spiral is developed. The 278

 Knowledge Management for Health Care and Long-Term Care

Table 1. KM in recent literature KM Strategy Author(s) and Year

Codification/ Personalization

Exploitation/ Exploration

Ju, Li, and Lee (2006) Ajith Kumar and Ganesh (2011)

System-Oriented/ Human-Oriented X

X

Durcikova, Fadel, Butler, and Galletta (2011)

X

López-Nicolás and Meroño-Cerdán (2011)

X

Martín-de Castro, López-Sáez, Delgado-Verde, Donate, and Guadamillas (2011)

X

Canzano and Grimaldi (2012)

X

Chai and Nebus (2012)

X

Jahn and Nielsen (2012)

X

Liu, Chai, and F. Nebus (2013)

X

Pourhamidi (2013)

X

X

Shahzad, Zia, Aslam, Syed, and Bajwa (2013)

X

Yousif Al-Hakim and Hassan (2013)

X

AL-Hakim and Hassan (2014)

X

Arvanitis and Woerter (2014)

X

Daraei and Vahidi (2014)

X

Shamah (2014)

X

Source: Lo and Ng (2015).

second key model is the European Foundation for Quality Management (EFQM) KM Model. According to Dalkir and Liebowitz (2011), this model illustrates how KM is used to achieve organizational goals. Enablers in EFQM model include leadership, people, policy and strategy, partnerships and resources, and processes. These crucial factors have significant impact on the key performance result in the EFQM KM model. Lastly, Girard (2005) has built the inukshuk KM Model for the Canadian government. This model is derived from SECI components. In addition, leadership, technology, culture, measurement and the types of knowledge (tacit and explicit) are incorporated.

WHY IS KNOWLEDGE MANAGEMENT SO IMPORTANT IN HEALTHCARE? Due to the generation of massive amounts of data, such as clinical trial data, electronic medical records, hospital records and administrative reports (Abidi, 2001), healthcare becomes a highly complex, evidence-based environment and a knowledge intensive industry (Ferlie et al., 2015). It is necessary to transform the “data rich” into a strategic decision-support system, so that the integration of knowledge and knowledge sharing can be better achieved among healthcare stakeholders. Bordoloi and Islam (2012, p.110) states that “healthcare delivery is a knowledge driven process and knowledge management provides an opportunity for improvement in process performance”. Effective KM helps to develop a culture of learning among healthcare stakeholders with the following benefits:

279

 Knowledge Management for Health Care and Long-Term Care

• • • • • •

Sharing information and methodology on healthcare initiatives; Providing more accurate and accessible information and knowledge resources; Increasing speed of response as a direct result of better knowledge access and application; Improving efficiency and quality of work; Developing capability and clinical competency of staff; Enhancing the collaboration with partners and relevant strategic stakeholders.

In addition, “knowledge translation” has been widely discussed in healthcare studies (Boström, 2012; Kitson, 2009; Scott et al., 2012; Straus et al., 2009). In a recent study by Straus et al. (2011, p.6), knowledge translation is defined as “the use of knowledge in practice and decision making”. Effective knowledge translation results in better decision making, and ultimately enhance productivity and improve health and quality of life (Straus et al., 2011). In the same vein, Metaxiotis (2011) points out that KM has the role to translate research results into policies and practices and finally lengthen survival and improve the quality of life. Other than knowledge translation, “knowledge transfer” and “knowledge exchange” are the emerging strategies which aim to facilitate the accessibility, applicability and production of evidence to healthcare settings by an interactive interchange of knowledge between research users and researcher producers (Motten et al., 2007; Pentland et al., 2011). With the increased demands on healthcare resources, generating knowledge by means of knowledge transfer and exchange may have significant impacts on the management of large healthcare organizations. Pentland et al. (2011) points out the key characteristics of knowledge transfer and knowledge exchange in healthcare settings (Table 2). Table 2. Key characteristics of knowledge transfer and knowledge exchange Relevance • Ensuring the relevance of research information or findings when sharing them with knowledge users Key characteristics of knowledge transfer – Sharing knowledge

Accessibility • Making research evidence information accessible to potential users • Tailoring the findings of research for specific audiences and ensuring its relevance Format and method • Clear and precise presentation is vital in improving probability of use • Knowledge sharing methods should be flexible enough to provide users with access to research evidence in various formats Collaborative research formulation • Collaboration and communication between researchers and health professionals during research formulation can generate new research knowledge

Key characteristics of knowledge exchange – Generating knowledge

Collaborative research production • Collaboration between those using research evidence and its producers in influencing clinical, planning and policy decisions • Establishing and maintaining quality relationships during collaborative research in knowledge exchange initiatives Collaborative dissemination • Collaboration during research makes action from knowledge more probable as it allows stakeholders the opportunity to inform implementation strategies by bringing local and context-specific knowledge to the process • Improving researchers’ understanding and appreciation of clinical environments

Source: Pentland et al. (2011).

280

 Knowledge Management for Health Care and Long-Term Care

With the proper design and implementation of knowledge transfer and exchange mechanisms in place, research knowledge can be communicated to clinical practitioners, thereby improving evidence-based practice and facilitating decision making by healthcare professionals in relevant large organizations and institutions. From these studies, it is observed that a close relationship exists among KM, knowledge translation, knowledge transfer and knowledge exchange, and quality healthcare. To sum up, KM plays an important role in achieving knowledge translation, knowledge transfer and knowledge exchange, which in turn achieves quality healthcare ultimately.

KNOWLEDGE MANAGEMENT SUCCESS STORIES IN HEALTHCARE This section aims to share three KM stories in the healthcare sector. To illustrate the importance of KM at different levels, stories from Hong Kong (regional level), England (country level) and World Health Organization (international level) were discussed. A comparison table with respect to the responsible KM unit, objectives and key contributions in these stories are presented.

Hong Kong: E-Knowledge Gateway at Hospital Authority Established in 1990, the Hospital Authority (HA) is a statutory body in Hong Kong which is responsible for the public hospitals and institutes management. By reviewing its vision, mission, values and strategic priorities, it can be ascertained that high quality medical services, staff learning and continuous improvement are advocated. Within the organization structure of the Hospital Authority, KM Unit was established under the Strategy and Planning Division of the HA Head Office. This establishment aims at “providing convenient, timely and easy access to expert-selected and best available information resources, and an environment conducive to research and knowledge sharing” (Hospital Authority, 2003, p.4). One of the key achievements is the “e-Knowledge Gateway”. According to KM Unit (2016), e-Knowledge Gateway is a KM tool designed for Hospital Authority professional staff. With Internet connection, healthcare professionals can access this KM platform to obtain “comprehensive and quality” medical knowledge. In 2000, KM unit started the e-Knowledge Gateway pilot project which aimed at facilitating the knowledge sharing among healthcare professionals. At that moment, e-Knowledge Gateway acted as a resource platform sharing medical information in four specialties (Hospital Authority, 2003). With the experience gained from pilot project, e-Knowledge Gateway was then migrated to the HA intranet in 2002, and finally moved to Internet in 2004. As a result, physicians, nurses and other healthcare staff can access the platform from anywhere and at any time. The number of specialties was increased from four to thirty-four. For instance, Chinese medicine and nursing specialty were incorporated into the eKnowledge Gateway in 2005 and 2007 respectively (Hospital Authority, 2005; Hospital Authority, 2007). With their slogan as stated in the website – “knowledge · anytime · anywhere”, healthcare professionals are now able to access a variety of resources, electronic healthcare journals, e-books, and databases, hence the knowledge sharing objective is undoubtedly achieved with overwhelming success.

England: Do Once and Share a National Health Service In England, National Health Service (NHS) is a publicly-funded healthcare system established in 1948. In order to reduce the medical errors occurrences and to improve the quality of patient care, National 281

 Knowledge Management for Health Care and Long-Term Care

Health Service has been actively launching different KM initiatives since 2003 (De Brún, 2007). Plaice & Kitch (2003) have reviewed that the practical drivers for KM development in National Health Service include patient-centered healthcare, evidence-based healthcare, workforce development, merger of trusts, information technology and clinical education. One of the projects was called “Do Once and Share”. In this project, different communities of practice were developed to facilitate healthcare professionals sharing their experience and practices in 50 clinical topics, like asthma and child health. As a result, commonly-agreed patient management approaches could be developed. According to NHS (2010), the “Do Once and Share” project has led to a win-win-win situation, namely: • • •

Patients can receive agreed and consistent treatment approaches; Healthcare professional are equipped with best medical knowledge at national standards; and National Health Service can save costs as inconsistencies are being reduced.

Apart from the “Do Once and Share” project, the National Health Service has also adopted the use of lesson cards Eurekas (a KM platform). When healthcare professionals learn a lesson, they externalize their experience in a form of document concisely and it will be shared via the platform. Other innovative KM initiatives include the use of Protocols and Care Pathways database and Map of Medicine. Recently, McCracken and Edwards (2015) conduct a qualitative study to examine key factors affecting the implementation of knowledge management systems at a National Health Service hospital. Seven factors are identified in this study and they are (1) business strategy; (2) fluid approach; (3) communication plan; (4) process mapping; (5) silo thinking and organizational structure; and (6) demand for knowledge. First, KM projects should be aligned with the organizational strategies which aim to solve business problems. Secondly, fluid approach refers to an adaptable and flexible way for KM systems implementation under the dynamic environment. Moreover, authors posit that both structured and unstructured communications should be incorporated in the communication plan. By winning their hearts and minds, healthcare professionals will be more eager to voice their opinions and barriers can be removed in an earlier stage. With the use of process map, clinical operations can be visualized. The effectiveness of KM projects can be enhanced by mapping appropriate initiatives with medical procedures. Furthermore, more knowledge can be shared across different units or specialties if silo thinking can be broken. Lastly, the study has developed the proposition that “KMS designed around patient care pathways are more effective than those organized by department” (McCracken and Edwards, 2015, p.9) – which emphasizes that understanding the knowledge needs is crucial to KM implementation.

World Health Organization The World Health Organization (WHO) has been established as a specialized group under the United Nations since 1948 and it focuses on global public health issues. Aligned with the strategic review in 2003, WHO sets up its Department of KM and Sharing with the aim of utilizing “technology to enable people to create, capture, store, retrieve, use and share knowledge” (World Health Organization. 2016a). WHO has identified that the “know-do” gap exists in healthcare sector. A “know-do” gap is the disconnection between “what is known” and “what is done in practice” (World Health Organization, 2005a). Working closely with the region offices in Zimbabwe, India, Egypt, USA, Denmark and Philippines and some external parties, the Department of KM and Sharing has implemented different KM initiatives which

282

 Knowledge Management for Health Care and Long-Term Care

aim at bridging this gap. The overview of the KM strategy can be illustrated with the slogan stated in their leaflet – “Innovation in sharing and applying knowledge for global health equity” (World Health Organization, 2005b). WHO’s global KM strategy attempts to: • • •

Strengthen country health systems through KM; Establishing KM in public health; and Enable WHO to become a better learning organization

In order to achieve the above-mentioned strategies, WHO puts the focus on five areas: (1) improving access to the world’s health information; (2) translating knowledge into policy and action; (3) sharing and reapplying experiential knowledge; (4) leveraging e-Health in countries; (5) fostering an enabling environment. Some countries have difficulties in accessing high-quality healthcare information while information overload exist in some regions. WHO has developed several measures to disseminate quality information and knowledge to healthcare professional located in different parts of the world. For instance, both print and electronic health-related multi-lingual journals and reports are available to be accessed through the network of libraries. Through the establishment of communities of practice, the best practice and lessons learned in public health are shared among healthcare professionals. Moreover, e-Health framework and its components are incorporated into existing health systems. In addition, the Department of KM and Sharing is also responsible to create and maintain the KM culture, to develop and deliver KM training workshops and to support the KM implementations in different regions and countries. Details of KM implementation are presented in Table 3. Although the sizes of the KM implementation and development in the Hospital Authority in Hong Kong, the National Health Service in England and the World Health Organization of United Nations differ substantially, KM still plays an important role in improving the healthcare service quality (Table 4). Table 3. KM implementation in World Health Organization Focus Area

Actions

Improving access to the world’s health information

• Support for WHO publications • WHO flagship publications • WHO network of libraries • WHO Web communications

Translating knowledge into policy and action

• Good practice and guidance on knowledge translation and scale-up • Building capability in KM methods in public health practice • Promote evidence for policy and decision making

Sharing and reapplying experiential knowledge

• Improve ability to share knowledge in public health • WHO and Global Health Histories • WHO Collaborating Centres

Leveraging e-Health in countries

• E-Health frameworks, guidelines and tools • E-Health services in countries • Country capacity building via ICT • Public-private partnerships in ICT

Fostering an enabling environment

• Foster a knowledge management culture • Develop and deliver KM training programmes • Support countries, technical programmes and partners

Source: World Health Organization (2016b).

283

 Knowledge Management for Health Care and Long-Term Care

Table 4. A comparison of KM success stories Criteria

Hospital Authority (Hong Kong)

National Health Service (England)

World Health Organization (United Nations)

Unit responsible for KM

KM Unit, Strategy and Planning Division, Head Office.

National Knowledge Service and The Knowledge & Intelligence team, NHS Improving Quality.

Department of Knowledge Management and Sharing.

Objective(s)

Provide convenient, timely and easy access to expert-selected and best available information resources, and an environment conducive to research and knowledge sharing.

Build knowledge sharing and learning capability, develop a repository storing success stories, form communities and adopt technology to share knowledge.

Improve the KM application through better information access, global collaborations, multilingual and quality publications and adoption of technologies.

Key contribution(s)

Developed a KM tool – e-Knowledge Gateway -which provides quality medical information to healthcare professionals.

Developed NHS Evidence (formerly called “National Electronic Library for Health”) and communities of practices … etc.

Fostered KM culture, delivered KM training, developed e-Health framework and related services, translated knowledge into policy/ action, published flagship products and provided network of libraries.

Source: Developed for this study.

KNOWLEDGE MANAGEMENT FOR LONG-TERM CARE KM can be used as a powerful tool to facilitate the generation, utilization, assimilation, dissemination and exchange of knowledge and information in healthcare (Röling and Engel, 1990; Jadad et al., 2000). The value of KM is also paramount in long-term care organizations and KM helps nursing homes improve their performance so as to deliver quality care (Guptill, 2005; Surve and Natarajan, 2015). To make KM more effective in long-term care, nursing home administrators first need to know what features and attributes of KM that fits their long-term care services (Anderson et al., 2003). An article written by Kandasamy Pasupathy, the president and CEO of InforSys, Inc. in 2006 addressed that KM systems assist long-term care users to turn miscellaneous information intro practical knowledge by “extracting information form databases and other electronic sources, filtering information according to user profiles, presenting information in concert with user preferences, condensing information, retrieving evidencebased reports, holding current information in a single point of reference, routing relevant information in a timely manner, alerting users to changers, and informing decision making” (Pasupathy, 2016, p.3). A survey conducted by a consulting firm in 2008 indicated that more than 58% of home care agencies surveyed in that report had electronic medical records (EMR) in place and the figure is higher than the 32.1% of home care agencies reported in the 2000 National Center for Health Statistics (NCHS) report (Resnick and Alwan, 2010). The growing figure shows the important use of KM in home health and hospice (HHH) care, viewing KM as an essential tool for improving healthcare quality. By implementing KM system, the staff members of nursing homes have quality information to respond to situations in a timely manner. Moreover, KM helps improve decisions and facilitates communication within long-term care organizations (Jadad et al., 2000). For instance, a KM system can provide nurses real-time information regarding patient orders and other pertinent clinical care information, making long-term care organizations more accountable. In addition, use of paper-based forms by physicians and other professionals can be reduced with an effective KM system as they can use KM to get timely access to patients’ information. Thus, physicians and other professionals are more encouraged to become involved in the care of nursing homes’ residents. “Almost all physicians and other professionals agreed

284

 Knowledge Management for Health Care and Long-Term Care

that correct and complete patient information improves healthcare” and long-term care delivery (Bordoloi and Islam, 2012, p.116). When the patient records and information can be accessed by physicians in a timely manner, patient care can be greatly improved so as to enhance quality of care. With KM systems in place, long-term care organizations are able to improve quality care on an ongoing basis.

PRIOR FRAMEWORKS IN LONG-TERM CARE A framework about KM capabilities for healthcare management systems is adopted in the study by Bose (2003). In healthcare organizations, sources of knowledge include: • • • • •

Documents: Admission, billing, medical research and drug references. Knowledge Warehouse: Patient record, medical procedures and hospital operations. Applications: Clinical decision support, quality assurance and knowledge mining. Best Practices: Procedures, disease diagnosis, pharmacy, emergency and nursing practices. Discussions: Cost reduction, fraud prevention, performance measurement and coordination of care.

With the KM capabilities in Table 5, existing knowledge can be transformed to new knowledge through knowledge learning loops. Bose (2003) classified KM capabilities into presentation, personalization, collaboration, process, publishing and distribution, integrated search, categorization and integration. Shared new knowledge enables healthcare organizations to lower the administrative costs and enhance the healthcare quality. Table 5. KM capabilities in healthcare organizations KM Capabilities

Main Function

Illustrative Items

Presentation

Designed for user interaction

• Enterprise knowledge portal • Visualization

Personalization

Customize content and services

• Collaborative filtering • Intelligent agents

Collaboration

Staff connect together via communities of practice, discuss and work together

• Groupware • Discussion forums

Process

Variety of processes in healthcare organizations

• Clinical process • Administrative and financial processes

Publishing and Distribution

A platform for capture and distribute knowledge assets

• Authoring • Webcasting and notification

Integrated search

Reduce information overload

• Search agents and spiders • Data-mining and filtering

Categorization

Allow users to access and create knowledge categories

• Ontology • Semantic definitions

Integration

Seamless navigation across all functions

• Knowledge repository • Learning and document management

Source: Bose (2003).

285

 Knowledge Management for Health Care and Long-Term Care

In Japan, Miyagawa et al. (2014) have developed a framework for professionals who are responsible for long-term care services management. The framework is composed of six key components (four agents and two databases). The first component is user agent, which includes care provider, care recipient and care recipient’s family. They can access information (e.g. aggregated case records) and submit requests to other agents. Secondly, the local information system access agent serves as the bridge between local information system and care community portal. Thirdly, the role of authentication/access control agent is to perform identity verification. After verification, sensitive information could be shared to care recipient. The last agent, namely priority control agent, is designed to determine / verify the priority of each update. Two databases include user database and care record index database. With this multi-agent framework, sensitive information can be shared / monitored with privacy and priority control.

KNOWLEDGE BARRIERS IN HEALTHCARE SETTINGS Knowledge stickiness has been shown to be one of the main barriers of knowledge transfer in previous studies (Sheng et al., 2013; Law, 2014). Knowledge stickiness is the major reason for knowledge transfer failure due to the inability or unwillingness to transfer knowledge, keeping knowledge from flowing (Sheng et al., 2013). Szulanski et al. (2016) have investigated the factors that make knowledge sticky and how sticky knowledge impacts on the process of knowledge transfer. Four major gaps in knowledge stickiness are identified when transferring knowledge or best practice in healthcare settings (Table 6). Apart from knowledge stickiness, an earlier study argues that both “knowledge source barriers” and “knowledge receiver barriers” hinder the flow of medical knowledge (Lin, Tan, & Chang, 2008). Healthcare professionals are busy and it may not be feasible for them to devote time in sharing or receiving knowledge. Other possible causes include the fear of losing ownership, not being adequately rewarded, lack of absorptive capacity and lack of retentive capacity (Lin, Wu, & Yen, 2012). Similarly, Khalifa (2013) has identified human barriers and financial barriers to KM implementation in health information systems and electronic medical records (EMR). Human barriers include lack of awareness Table 6. Knowledge stickiness in transferring best practice in healthcare settings Stages in Knowledge Transfer

Gaps

Remarks

Initiation stickiness

Difficulties in recognizing opportunities

Recognizing the opportunities for benchmarking best practice requires sufficient time and effort in delimiting and defining the best practice to be transferred.

Implementation stickiness

Technical and communication stickiness

Technical and communication gaps are developed during the phase when new knowledge is implemented. Thus, careful planning, establishing good relationship between the source and recipient of knowledge can minimize this gap.

Ramp-up stickiness

Casual ambiguity

Casual ambiguity means the basic ambiguity arising from the nature. This gap arises when precise reasons for success are not really understood during implementing the transferred knowledge. The bigger the casual ambiguity, the more likely the problems will be faced.

Integration stickiness

Obstacles when integrating new knowledge

When problems arise when implementing new knowledge or new practice, the new practice may be abandoned. Thus, success depends very much on the extent of removing obstacles and how to normalize new practice.

Source: Szulanski et al. (2016).

286

 Knowledge Management for Health Care and Long-Term Care

of the importance and benefits of using KM as well as the lack of experience of KM systems (Manson and Pauleen, 2003). To reduce the human barriers, it is suggested that training on KM tools should be developed and implemented comprehensively as a course or a subject in medical education programmes. Dixon et al. (2013) point out that financial barriers is one of the major categories of barriers in the way of successful implementation of KM, including high initial cost of KM implementation, and high operations and maintenance cost of KM systems. In order to overcome such financial barriers, Khalifa (2013) suggests the followings: • • • •

Allocating proper ongoing funding and adequate capital investments. Designing systems for the annual budgets of the healthcare organizations to accommodate the higher recurrent operation and maintenance costs. Proper planning of healthcare resources and logistics in the phases of KM implementation. Conducting feasibility studies regarding benefits vs costs of initiating / implementing KM.

To overcome knowledge barriers and foster knowledge transfer, healthcare organizations should focus and rely on factors regarding people, organization, technology and environment, i.e. the TechnologyOrganization-Environment (TOE) framework.

KNOWLEDGE MANAGEMENT FOR LONG-TERM CARE IN THE TOE FRAMEWORK KM focuses on achieving a balance across people, organization and technology which helps connecting people with organizations through the use of technology (Bhatt, 2001). The optimum KM theoretically relies on the TOE framework (Lin, 2014; Kim et al., 2014). The TOE framework is an organization-level theory that explains three different elements of a firms’ context influence adoption decision (Baker, 2012). TOE framework is a comprehensive tool for explaining the adoption of innovation, such as KM, in an organizational context (Ahmadi et al., 2015). Different contextual factors affecting KM effectiveness for long-term care can be closely examined in the TOE context.

Dimension of Technology Technology plays a crucial role in innovative KM adoption among healthcare professionals. The results in the study by Yun (2013) have revealed that at the hospital level, the capacity for IT-based innovation positively influences the usage of KM systems among nurses in Seoul, Korea. A number of technologies are implemented in hospitals and healthcare organizations. First, cloud applications are frequently adopted in the healthcare industry (Li, Zheng, Ren & Lou, 2013; Lian, Yen & Wang, 2014; Sultan, 2014). Lai, Tam & Chan (2012) have developed a model of knowledge cloud system (known as knowledge-as-a-service (KaaS) framework), which facilitates the information sharing and collaboration among professionals in Chinese medical service industry. Secondly, the adoption of radio frequency identification (RFID) is increasing significantly in healthcare sector (Chong & Chan, 2012; Lu, Lin, & Tzeng, 2013; Yao, Chu & Li, 2012). Yao et al. (2012) point out that the barriers of RFID implementation include technological limitations, costs (including hardware, software, training and maintenance) and privacy issue.

287

 Knowledge Management for Health Care and Long-Term Care

The Application of Technologies in Long-Term Care Organizations Blaschke et al. (2009) argue that both assistive technologies and information and communication technologies can help long-term care patients or the elderlies to improve their quality of life, and physical and mental health status. Assistive technologies, including behaviour monitoring tools, smart homes, and telehealth tools, could tackle the safety and health issues. Recently, an integrated tracking with 3G smartwatch was designed for elderly. Without connecting to mobile phone, elderly or dementia patients just simply press the one-touch SOS button and the alert, with identification of the location, will be transmitted to family members (McGlaun, 2016). Moreover, The Hong Kong Polytechnic University (PolyU) and its licensee Rehab-Robotics Company Limited have designed a robotic technology, namely “Hand of Hope”, to assist stroke patients in moving their paralyzed hands (PolyU, 2008). This device has been adopted by seven public hospitals and rehabilitation centres in Hong Kong. Moreover, it is now recognized by the European Commission, and has been exported to more than twenty countries (BIPAsia, 2016). According to Muoio (2015), one fifth of the population in Japan are elderlies, aged 65 or older. The current number of care-givers cannot meet the demand of elderly services. Therefore, several Japanese companies have designed “Carebots” to address this issue. “Carebots” are robots designed for the elderlies, long-term care patients, blind people and those in need. Based on the information provided by The International Organization for Standardization, robots can be classified into three groups: (1) person carrier robots; (2) physical assistant robots; and (3) mobile servant robots. ASIMO, a humanoid robot developed by Honda, is able to help the elderlies by feeding them food, by walking up and down steps with them in a house and by turning on and off the lights (Honda, 2004). Feedback from long-term care users and data collected from these devices can be analyzed for better clinical decision-making and better knowledge sharing. Apart from the assistive technologies, there are a variety tools supporting clinical KM. In a healthcare KM study, Dwivedi (2007) has highlighted that KM technologies (including Internets, intranets and extranets) support a variety KM processes (identification, creation, collection, storage and access). Sittig et al. (2010) have identified four tools to support clinical KM. The first one is the web-based clinical content repository. The browse-able and searchable repository provides a platform for healthcare professionals to maintain, share and review clinical knowledge. Secondly, a web-based collaborative content management system definitely facilitates the knowledge sharing among doctors, nurses, pharmacists and other healthcare professionals. Through asynchronous discussion, opinions from different stakeholders can be voiced and consensus can be reached faster. The third and fourth tools are the enterprise-wide clinical terminology controlling tool and users’ feedback tool respectively. Both positive and negative experience from patients can be shared among healthcare professionals and the top management. However, Sittig et al. (2010) point out that costs, user involvement (incentive issue), and regulatory reporting and compliance requirements are the barriers to effective clinical KM. More recently, Dixon et al. (2013) have conducted a pilot study to examine a cloud-based KM and clinical decision support system. Although the performance of this KM tool is satisfactory, several concerns (including governance, semantic interoperability and usability) have to be further explored and addressed. Particularly, security under the governance theme is considered as a critical issue. Both the healthcare and technology professionals should work closely in order to enhance the adoption of cloud-based KM systems. Factors influencing the innovative KM adoption are widely discussed. Technology integration, technology competence and security concern are the criteria adopted in the study by Lu et al. (2013). Lian et al. (2014) have measured technology in terms of security, complexity, compatibility and costs. In a 288

 Knowledge Management for Health Care and Long-Term Care

more recent study, relative advantage, compatibility, complexity and security are the variables used in technology dimension of the research framework (Ahmadi et al., 2015). Based on the discussion above, this chapter adopts three dimensions, namely: security, complexity, and costs for measuring the technological context in healthcare organizations.

Dimension of Organization Several studies have supported that top management support is considered to be highly important in the KM process in the healthcare organizations (Lu et al., 2013; Yun, 2013; Ahamdi et al., 2015). Top management support is a key factor in overcoming resistance to changes caused by new technology adoption and diffusion, and providing vision and commitment to create a positive effect in the successful KM process (Lu et al., 2013). As the value of KM investments has been considered as an important issue for top management, a balanced scorecard approach may be appropriate to measure KM performance in long-term care organizations (Wu and Kuo, 2012). A suitable balanced scorecard structure was established by Voelker et al. (2001) for the healthcare sector (Figure 1). In order to effectively link mission, stakeholders, financial, internal process, and learning and growth in long-term care organizations, the balanced scorecard structure becomes an integrated as well as crucial tool for measuring them. Innovation process and information capital can be evaluated within the perspectives of internal process and learning and growth in order to measure the overall effectiveness of KM. The performance measures of innovation process and information capital are presented in Table 7. Organizational size has been regarded as important in the literature. Large firms, i.e. large healthcare institutes, typically have more resources necessary for implementing KM with the adoption of innovative technology. Thus, the size of healthcare organizations (Baker, 2012) has contributed a significant influence on the success factor of the KM process. Large healthcare organizations have resources dedicated to internal knowledge management efforts in support of the KM process so as to provide the best possible Figure 1. The balanced scorecard structure for nonprofit organizations Source: Voelker et al. (2002).

289

 Knowledge Management for Health Care and Long-Term Care

Table 7. Balanced scorecard measures for KM Perspectives

Objectives

Measures

Internal process

Innovation process

• Identify more innovative opportunities for long-term care • Develop innovative medical service • Design innovative administrative service

Learning and growth

Information capital

• Improve quality of information • Improve capabilities of KM • Improve accessibility of various information

Source: Wu and Kuo (2012).

healthcare, achieving operational excellence while fostering innovation. Apart from the organizational size and in order to achieve better performance in long-term care, enhancing nursing leadership is a vital move. It is well recognized that nurses are essential in the improvement of the quality of care (Harvarth et al., 2008). Thus, enhancing nursing leadership in long-term care is absolutely necessary and is considered as “a must”. According to McBride et al. (2006), leadership in nursing ties with personality characteristics or traits, such as responsiveness, commitment, vision, courage, innovation, etc. Other than the importance of personality traits, it is also imperative for nurses or nursing leaders to develop necessary skills and knowledge to motivate long-term care organizations to implement changes. Nursing leadership enhancement programmes can be delivered so as to provide comprehensive training for nurses or nursing leaders in order to strengthen their leadership skills. The dimensions of skills that nursing leaders should acquire include interpersonal skills, clinical skills, organizational skills and management skills (Harvarth et al., 2008). Table 8 shows the core content for nursing leadership enhancement programmes that can be implemented, especially in long-term care service organizations. Healthcare professionals include medical doctors, nurses, caretakers, and other frontline staff. There are many prior studies discussing the critical role of nurse in long term care (Brazil, Brink, Kaasalainen, Kelly, & McAiney, 2012; Brühl, Luijendijk & Muller, 2007; Edwards, McClement, & Read, 2013); Hunter & Levett‐Jones, 2010; Joy, Carter, & Smith, 2000) This study would put the emphasis on nursing leadership. Leadership training programmes for nurses in long-term care are needed in order to improve the quality of care in long-term care organizations. If nursing leaders are fully equipped with a set of leadership skills, the demand on ability to effect changes at all levels within an organization could be maximized. Organizational readiness refers to the extent of readiness of healthcare sectors to get prepared for making business process changes. According to Weiner et al. (2008), the estimated success rates for businesses implementing changes range from 20% to 60% depending on the type of change. Hence, getting long-term care organizations prepared for change, e.g. adopting innovative KM technology, is significant. In fact, innovative cultures have been shown to link efficient organizational practice and high quality long-term care (Berta et al., 2005; Aylward et al., 2003). KM stimulates cultural change and innovative practices, while innovation cultures facilitate “the creation and implementation of new ideas and work methods” in long-term care (Nieboer & Strating, 2012, p.166). Scott et al. (2003) have also reported that organizational characteristics influence the innovation cultures in long-term care settings. Nieboer and Strating (2012) have conducted a study in Dutch long-term care service in order to investigate how organizational characteristics influence the innovative cultures in long-term care. Their findings have shown that formal external exchange of information, transformational leadership, commitment to qual-

290

 Knowledge Management for Health Care and Long-Term Care

Table 8. Contents for nursing leadership enhancement programmes Dimensions

Beaulieu (1997)

Hollinger-Smith and Ortigara (2004)

Wilson (2005)

Huber (2013)

X

X

Interpersonal Skills Communication

X

X

Motivation Conflict resolution Relationship building

X

X

X

X

X

Clinical Skills Use of best practices

X

Person-centered care

X Organizational Skills

Vision Team building

X X

Change Theory

X

X

X

X

X

X

Management Skills HR policy and procedures

X

Employee supervision & mentoring

X

Quality improvement

X

X

X X

X

Source: Developed for this study.

ity and exploratory innovative strategy were all significantly linked to innovative cultures. Therefore, in order to develop and strengthen innovative cultures for making organizations change, efforts should be made to align organizational characteristics with organizational goals that foster innovation. Al-Balushi et al. (2014) have determined that communication is the critical organizational readiness factor to healthcare organizations. The readiness factor assists organizational transformation by eliminating inhibitors or providing the required capabilities and knowledge in order to establish change for organizations, leading for success (Abdolvand et al., 2008; Shea et al., 2014). As several customer groups exist in long-term care setting, (such as patients, relatives of the patients, nursing home administrators, nurses, doctors, decision makers, etc., there is a need for each customer group to be communicated appropriately so as to prevent conflicts and reduce resistance to change. Thus, getting prepared for change or organizational shift, communication strategy is an essential contributor to the readiness factor (McKay et al., 2013).

Dimension of Environment Long-term care organizations are increasingly aware of the dynamic change of the competitive environment. The influence of the external environment in an organization’s decision to adopt an innovation is highlighted in the healthcare industry, especially in long-term care settings. Competitive pressure and vendor supports are regarded as the important external factors in previous studies (Baker, 2012; Bhattacharya et al., 2015; Lu et al., 2013). Competitive pressure refers to the extent to which an innovation is adopted in the firm’s industry (Bhattacharya et al., 2015). The implementation of KM systems is an

291

 Knowledge Management for Health Care and Long-Term Care

innovation adoption in the healthcare sector. If the healthcare organization perceives that the adoption of KM systems by other healthcare organizations is beneficial or successful, the healthcare organization faces high level of competitive pressure that triggers corresponding strategic move of similar innovation adoption (Ahmadi et al., 2015). According to Nieboer and Strating (2012), the extent of an organization’s competitive environment influences the organization’s innovative culture positively. In order to improve the development and implementation of innovations, a clear strategic vision should be set in response of changes in the environment. The role of vendor has been discussed for a long period of time. One of the pitfalls that KM professionals should avoid is the “challenging software with poor vendor support” (Sharp, 2003). Ngai and Chan (2005) put forward that the successful KM systems installation and maintenance depended on the matching quality of vendor support. The study further classifies the vendor supports into five main categories: (1) vendor reputation; (2) training; (3) implementation partner; (4) KM consulting services; and (5) support, maintenance, upgrade and integration. First, vendor reputation includes their expertise and experience in KM industry. For example, an experienced KM system vendor can provide quality support services and more confidence to their clients. Secondly, both KM training and product-specific user training should be available to the clients. Moreover, successful implementation highly depends on a reliable and experienced implementation partner. Fourthly, consulting service is essential to those organizations without any KM experience. Similar to other information systems, organizations may need to improve and upgrade their KM systems so as to meet the changing needs. Ongoing vendor support should be available to the clients. In the same vein, Buyukozkan and Feyzioglu (2008) have advised organizations to evaluate vendor reputation, stability and service support when choosing KM tools or solutions. As mentioned by Bhattacharya et al. (2015), vendors are more willing to invest in larger healthcare organizations so as to maintain an innovation of the long-term care organizations. Vendor support has been identified as a determinant of innovation adoption. Thus, long-term care organizations which experience greater vendor support are more likely to adopt innovative KM systems as part of the initiatives for changes and long-term improvements. By summarizing the factors affecting the adoption of KM, the conceptual framework for this study is proposed on the basis of the TOE framework which is shown in Figure 2.

CONCLUSION AND FUTURE RESEARCH DIRECTION KM in the long-term care service industry is progressing and the use of KM is promising to enhance the quality of care for patients by conducing evidence based practice with the best knowledge available. The delivery of healthcare service is knowledge-intensive and data-driven process, while KM and KM tools provide opportunities for improving the process performance in the long-term care industry. In addition, KM can be used to appraise performance in long-term care organizations and previous studies have noted that KM processes do have positive effect on organizational performance. The adoption of KM can impact the efficiency of healthcare delivery in terms of turning miscellaneous information into practical knowledge as a source of competitive advantage. Through literature analysis and cases, this chapter seeks to develop a suitable framework to understand the effectiveness of KM in long-term care organizations. To overcome knowledge barriers and foster knowledge transfer, healthcare organizations should rely on a number of crucial factors such as people,

292

 Knowledge Management for Health Care and Long-Term Care

Figure 2. A conceptual framework Source: Developed by authors.

organization, technology and environment. Moreover, to enhance the effectiveness of KM system, critical factors have been examined using the TOE framework. From prior studies, security, complexity, costs, top management support, firm size, leadership, organizational readiness, competitive pressure and vendor support have been proven as critical factors affecting the innovation adoption of KM systems in the context of technological, organizational and environmental dimensions. In the future, researchers are encouraged to design a questionnaire and to collect primary data from healthcare organizations which are specialized in long term care. In the questionnaire, each construct in technological context, organizational context and environmental context is measured with multi-items. Partial Least Squares can be adopted to examine the relationships within the model in this study. From the result, the management from healthcare organizations is expected to gain insights in formulating appropriate KM strategy for performance excellence.

REFERENCES Abdolvand, N., Albadvi, A., & Ferdowsi, Z. (2008). Assessing readiness for business process reengineering. Business Process Management Journal, 14(4), 497–511. doi:10.1108/14637150810888046

293

 Knowledge Management for Health Care and Long-Term Care

Abidi, S. S. R. (2001). Knowledge management in healthcare: Towards knowledge-driven decision-support services. International Journal of Medical Informatics, 63(1), 5–18. doi:10.1016/S1386-5056(01)001678 PMID:11518661 Ahmadi, H., Ibrahim, O., & Nilashi, M. (2015). Investigating a new framework for hospital information system adoption: A case on Malaysia. Journal of Soft Computing and Decision Support Systems, 2(2), 26–33. Al-Balushi, S., Sohal, A. S., Singh, P. J., Al Hajri, A., Al Farsi, Y. M., & Al Abri, R. (2014). Readiness factors for lean implementation in healthcare settings–a literature review. Journal of Health Organization and Management, 28(2), 135–153. doi:10.1108/JHOM-04-2013-0083 PMID:25065107 Anderson, R. A., Issel, L. M., & McDaniel, R. R. Jr. (2003). Nursing homes as complex adaptive systems: Relationship between management practice and resident outcomes. Nursing Research, 52(1), 12–21. doi:10.1097/00006199-200301000-00003 PMID:12552171 Aylward, S., Stolee, P., Keat, N., & Johncox, V. (2003). Effectiveness of continuing education in long-term care: A literature review. The Gerontologist, 43(2), 259–271. doi:10.1093/geront/43.2.259 PMID:12677083 Beaulieu, R., Shamian, J., Donner, G., & Pringle, D. (1997). Empowerment and commitment of nurses in long-term care. Nursing Economics, 15(1), 32–42. PMID:9087042 Berta, W., Teare, G. F., Gilbart, E., Ginsburg, L. S., Lemieux-Charles, L., Davis, D., & Rappolt, S. (2005). The contingencies of organizational learning in long-term care: Factors that affect innovation adoption. Health Care Management Review, 30(4), 282–292. doi:10.1097/00004010-200510000-00002 PMID:16292005 Bharati, P., Zhang, W., & Chaudhury, A. (2015). Better knowledge with social media? Exploring the roles of social capital and organizational knowledge management. Journal of Knowledge Management, 19(3), 456–475. doi:10.1108/JKM-11-2014-0467 Bhatt, G. D. (2001). Knowledge management in organizations: Examining the interaction between technologies, techniques, and people. Journal of Knowledge Management, 5(1), 68–75. doi:10.1108/13673270110384419 Bhattacharya, M., & Wamba, S. F. (2015). A Conceptual Framework of RFID Adoption in Retail Using TOE Framework. International Journal of Technology Diffusion, 6(1), 1–32. doi:10.4018/IJTD.2015010101 BIPAsia. (2016). Actively Promoting Intellectual Property Trading HK PolyU’s “Hand of Hope” gains international recognition. Retrieved 20 July 2016, from http://bipasiaforum.com/en/success_stories/ int_Actively_Promoting.html Blaschke, C. M., Freddolino, P. P., & Mullen, E. E. (2009). Ageing and technology: A review of the research literature. British Journal of Social Work, 39(4), 641–656. doi:10.1093/bjsw/bcp025 Bordoloi, P., & Islam, N. (2012). Knowledge management practices and health care delivery: A contingency framework. Electronic Journal of Knowledge Management, 10(2), 110–120.

294

 Knowledge Management for Health Care and Long-Term Care

Bose, R. (2003). Knowledge management-enabled health care management systems: Capabilities, infrastructure, and decision-support. Expert Systems with Applications, 24(1), 59–71. doi:10.1016/ S0957-4174(02)00083-0 Boström, A. M., Slaughter, S. E., Chojecki, D., & Estabrooks, C. A. (2012). What do we know about knowledge translation in the care of older adults? A scoping review. Journal of the American Medical Directors Association, 13(3), 210–219. doi:10.1016/j.jamda.2010.12.004 PMID:21450230 Brazil, K., Brink, P., Kaasalainen, S., Kelly, M. L., & McAiney, C. (2012). Knowledge and perceived competence among nurses caring for the dying in long-term care homes. International Journal of Palliative Nursing, 18(2), 77–83. doi:10.12968/ijpn.2012.18.2.77 PMID:22399045 Brühl, K. G., Luijendijk, H. J., & Muller, M. T. (2007). Nurses and nursing assistants recognition of depression in elderly who depend on long-term care. Journal of the American Medical Directors Association, 8(7), 441–445. doi:10.1016/j.jamda.2007.05.010 PMID:17845946 Buyukozkan, G., & Feyzioglu, O. (2008, July). A decision framework for the evaluation of the knowledge management tools. In PICMET’08-2008 Portland International Conference on Management of Engineering & Technology (pp. 1075-1084). IEEE. 10.1109/PICMET.2008.4599717 Choi, B., & Lee, H. (2003). An empirical investigation of KM styles and their effect on corporate performance. Information & Management, 40(5), 403–417. doi:10.1016/S0378-7206(02)00060-5 Choi, B., Poon, S. K., & Davis, J. G. (2008). Effects of knowledge management strategy on organizational performance: A complementarity theory-based approach. Omega, 36(2), 235–251. doi:10.1016/j. omega.2006.06.007 Chong, A. Y. L., & Chan, F. T. (2012). Structural equation modeling for multi-stage analysis on radio frequency identification (RFID) diffusion in the health care industry. Expert Systems with Applications, 39(10), 8645–8654. doi:10.1016/j.eswa.2012.01.201 Dalkir, K., & Liebowitz, J. (2011). Knowledge Management in Theory and Practice. Cambridge, MA: MIT Press. De Brún, C. (2007). Knowledge management and the national health service in England. In R. Bali & A. Dwivedi (Eds.), Healthcare Knowledge Management (pp. 179–188). New York, NY: Springer. doi:10.1007/978-0-387-49009-0_13 Dixon, B. E., Simonaitis, L., Goldberg, H. S., Paterno, M. D., Schaeffer, M., Hongsermeier, T., ... Middleton, B. (2013). A pilot study of distributed knowledge management and clinical decision support in the cloud. Artificial Intelligence in Medicine, 59(1), 45–53. doi:10.1016/j.artmed.2013.03.004 PMID:23545327 Dwivedi, A. N., Bali, R. K., & Naguib, R. N. (2007). Building new healthcare management paradigms: A case for healthcare knowledge management. In R. Bali & A. Dwivedi (Eds.), Healthcare Knowledge Management (pp. 3–10). New York, NY: Springer. doi:10.1007/978-0-387-49009-0_1 Edwards, M. P., McClement, S. E., & Read, L. R. (2013). Nurses responses to initial moral distress in longterm care. Journal of Bioethical Inquiry, 10(3), 325–336. doi:10.100711673-013-9463-6 PMID:23793936

295

 Knowledge Management for Health Care and Long-Term Care

Ferlie, E., Crilly, T., Jashapara, A., Trenholm, S., Peckham, A., & Currie, G. (2015). Knowledge mobilization in healthcare organizations: A view from the resource-based view of the firm. International Journal of Health Policy and Management, 4(3), 127–130. doi:10.15171/ijhpm.2015.35 PMID:25774369 Fugate, B. S., Stank, T. P., & Mentzer, J. T. (2009). Linking improved knowledge management to operational and organizational performance. Journal of Operations Management, 27(3), 247–264. doi:10.1016/j.jom.2008.09.003 Girard, J. P. (2005). The Inukshuk: A Canadian knowledge management model. KMPro Journal, 2(1), 9–19. Guptill, J. (2005). Knowledge management in health care. Journal of Health Care Finance, 31(3), 10–14. PMID:16080410 Hansen, M. T., Nohria, N., & Tierney, T. (1999). What’s your strategy for managing knowledge? In J. A. Woods & J. Cortada (Eds.), The Knowledge Management Yearbook 2000–2001 (pp. 55–69). Butterworth Heinemann. Harvath, T. A., Swafford, K., Smith, K., Miller, L. L., Volpin, M., Sexson, K., ... Young, H. A. (2008). Enhancing nursing leadership in long-term care: A review of the literature. Research in Gerontological Nursing, 1(3), 187–196. doi:10.3928/00220124-20091301-06 PMID:20077963 Ho, L. A. (2008). What affects organizational performance? The linking of learning and knowledge management. Industrial Management & Data Systems, 108(9), 1234–1254. doi:10.1108/02635570810914919 Hollinger-Smith, L., & Ortigara, A. (2004). Changing Culture: Creating a Long‐Term Impact for a Quality Long‐Term Care Workforce. Alzheimer’s Care Today, 5(1), 60–70. Honda. (2004). The Bronx Says “Hello” to ASIMO! Retrieved 20 July 2016, from http://asimo.honda. com/event-details.aspx?XML=Events/PostEvent_0026.xml Hospital Authority. (2003). HA and Clinical Research - Support, Output & Direction. Retrieved 20 July 2016, from http://www.ha.org.hk/ho/research_ethics/msdc_p181.pdf Hospital Authority. (2005). Highlights of Hospital Authority Annual Plan 2005/06. Retrieved 20 July 2016, from http://www.ha.org.hk/haho/ho/cad_bnc/126135e.pdf Hospital Authority. (2007). Chief Executive’s Progress Report on Strategic Priorities. Retrieved 20 July 2016, from http://www.ha.org.hk/haho/ho/cad_bnc/131443e.pdf Hunter, S., & Levett‐Jones, T. (2010). The practice of nurses working with older people in long term care: An Australian perspective. Journal of Clinical Nursing, 19(3‐4), 527–536. doi:10.1111/j.13652702.2009.02967.x PMID:20500289 Jadad, A. R., Haynes, R. B., Hunt, D., & Browman, G. P. (2000). The Internet and evidence-based decision-making: A needed synergy for efficient knowledge management in health care. Canadian Medical Association Journal, 162(3), 362–365. PMID:10693595

296

 Knowledge Management for Health Care and Long-Term Care

Joy, J. P., Carter, D. E., & Smith, L. (2000). The evolving educational needs of nurses caring for the older adult: A literature review. Journal of Advanced Nursing, 31(5), 1039–1045. doi:10.1046/j.13652648.2000.01392.x PMID:10840236 Khalifa, M. (2013). Barriers to health information systems and electronic medical records implementation. A field study of Saudi Arabian hospitals. Procedia Computer Science, 21, 335–342. doi:10.1016/j. procs.2013.09.044 Kim, T. H., Lee, J. N., Chun, J. U., & Benbasat, I. (2014). Understanding the effect of knowledge management strategies on knowledge management performance: A contingency perspective. Information & Management, 51(4), 398–416. doi:10.1016/j.im.2014.03.001 Kitson, A. L. (2009). The need for systems change: Reflections on knowledge translation and organizational change. Journal of Advanced Nursing, 65(1), 217–228. doi:10.1111/j.1365-2648.2008.04864.x PMID:19032518 Lai, I. K., Tam, S. K., & Chan, M. F. (2012). Knowledge cloud system for network collaboration: A case study in medical service industry in China. Expert Systems with Applications, 39(15), 12205–12212. doi:10.1016/j.eswa.2012.04.057 Law, K. K. (2014). The problem with knowledge ambiguity. European Management Journal, 32(3), 444–450. doi:10.1016/j.emj.2013.07.010 Lee, S., Gon Kim, B., & Kim, H. (2012). An integrated view of knowledge management for performance. Journal of Knowledge Management, 16(2), 183–203. doi:10.1108/13673271211218807 Li, M., Yu, S., Zheng, Y., Ren, K., & Lou, W. (2013). Scalable and secure sharing of personal health records in cloud computing using attribute-based encryption. IEEE Transactions on Parallel and Distributed Systems, 24(1), 131–143. doi:10.1109/TPDS.2012.97 Lian, J. W., Yen, D. C., & Wang, Y. T. (2014). An exploratory study to understand the critical factors affecting the decision to adopt cloud computing in Taiwan hospital. International Journal of Information Management, 34(1), 28–36. doi:10.1016/j.ijinfomgt.2013.09.004 Liao, S. H., & Wu, C. C. (2009). The relationship among knowledge management, organizational learning, and organizational performance. International Journal of Business and Management, 4(4), 64. doi:10.5539/ijbm.v4n4p64 Lin, C., Tan, B., & Chang, S. (2008). An exploratory model of knowledge flow barriers within healthcare organizations. Information & Management, 45(5), 331–339. doi:10.1016/j.im.2008.03.003 Lin, C., Wu, J. C., & Yen, D. C. (2012). Exploring barriers to knowledge flow at different knowledge management maturity stages. Information & Management, 49(1), 10–23. doi:10.1016/j.im.2011.11.001 Lin, H. F. (2014). A multi-stage analysis of antecedents and consequences of knowledge management evolution. Journal of Knowledge Management, 18(1), 52–74. doi:10.1108/JKM-07-2013-0278

297

 Knowledge Management for Health Care and Long-Term Care

Lo, M. F., & Ng, P. M. L. (2015). Role of codification and personalization in organizational learning, innovation and performance: A conceptual framework and research propositions. The 12th International Conference on Intellectual Capital, Knowledge Management & Organizational Learning, Bangkok, Thailand. López-Nicolás, C., & Meroño-Cerdán, Á. L. (2011). Strategic knowledge management, innovation and performance. International Journal of Information Management, 31(6), 502–509. doi:10.1016/j. ijinfomgt.2011.02.003 Low, C., Chen, Y., & Wu, M. (2011). Understanding the determinants of cloud computing adoption. Industrial Management & Data Systems, 111(7), 1006–1023. doi:10.1108/02635571111161262 Lu, M. T., Lin, S. W., & Tzeng, G. H. (2013). Improving RFID adoption in Taiwans healthcare industry based on a DEMATEL technique with a hybrid MCDM model. Decision Support Systems, 56, 259–269. doi:10.1016/j.dss.2013.06.006 March, J. G. (1991). Exploration and exploitation in organizational learning. Organization Science, 2(1), 71–87. doi:10.1287/orsc.2.1.71 Mason, D., & Pauleen, D. J. (2003). Perceptions of knowledge management: A qualitative analysis. Journal of Knowledge Management, 7(4), 38–48. doi:10.1108/13673270310492930 McBride, A. B., Fagin, C. M., Franklin, P. D., Huba, G. J., & Quach, L. (2006). Developing geriatric nursing leaders via an annual leadership conference. Nursing Outlook, 54(4), 226–230. doi:10.1016/j. outlook.2006.05.003 PMID:16890042 McCracken, S. S., & Edwards, J. S. (2015). Implementing a knowledge management system within an NHS hospital: a case study exploring the roll-out of an electronic patient record (EPR). Knowledge Management Research & Practice, 1-11 McKay, K., Kuntz, J. R., & Naswall, K. (2013). The effect of affective commitment, communication and participation on resistance to change: The role of change readiness. New Zealand Journal of Psychology, 42(2), 29–40. Metaxiotis, K. S. (2011). Healthcare Knowledge Management. In D. G. Schwartz (Ed.), Encyclopedia of Knowledge Management (pp. 204–210). London, UK: Idea Group Inc. Mitton, C., Adair, C. E., McKenzie, E., Patten, S. B., & Perry, B. W. (2007). Knowledge transfer and exchange: Review and synthesis of the literature. The Milbank Quarterly, 85(4), 729–768. doi:10.1111/ j.1468-0009.2007.00506.x PMID:18070335 Miyagawa, S., Yamasaki, S., Uchiyama, E., & Amoroso, D. L. (2014). Framework for information sharing with privacy and priority control in long-term care in Japan. International Journal of E-Health and Medical Communications, 5(1), 46–62. doi:10.4018/ijehmc.2014010103 Moustaghfir, K., & Schiuma, G. (2013). Knowledge, learning, and innovation: Research and perspectives. Journal of Knowledge Management, 17(4), 495–510. doi:10.1108/JKM-04-2013-0141

298

 Knowledge Management for Health Care and Long-Term Care

Muoio, D. (2015). Japan is running out of people to take care of the elderly, so it’s making robots instead. Retrieved 20 July 2016, from http://www.techinsider.io/japan-developing-carebots-for-elderlycare-2015-11 Ngai, E. W., & Chan, E. W. C. (2005). Evaluation of knowledge management tools using AHP. Expert Systems with Applications, 29(4), 889–899. doi:10.1016/j.eswa.2005.06.025 NHS. (2010). Do Once and Share Factsheet. Retrieved 20 July 2016, from http://webarchive.nationalarchives.gov.uk/20130502102046/http://www.connectingforhealth.nhs.uk/resources/systserv/do-once-and Nieboer, A. P., & Strating, M. M. (2012). Innovative culture in long-term care settings: The influence of organizational characteristics. Health Care Management Review, 37(2), 165–174. doi:10.1097/ HMR.0b013e318222416b PMID:21720249 Nonaka, I., & Takeuchi, H. (1995). The knowledge-creating company: How Japanese companies create the dynamics of innovation. Oxford University Press. Noruzy, A., Dalfard, V. M., Azhdari, B., Nazari-Shirkouhi, S., & Rezazadeh, A. (2013). Relations between transformational leadership, organizational learning, knowledge management, organizational innovation, and organizational performance: An empirical investigation of manufacturing firms. International Journal of Advanced Manufacturing Technology, 64(5-8), 1073–1085. doi:10.100700170-012-4038-y Pan, M. J., & Jang, W. Y. (2008). Determinants of the adoption of enterprise resource planning within the technology-organization-environment framework: Taiwan’s communications industry. Journal of Computer Information Systems, 48(3), 94–102. Pasupathy, K. (2016). Knowledge Management in Long-term Care: What You Need to Now. Accessed at: http://www.ltlmagazine.com/article/knowledge-management-long-term-care-what-you-need-know Pentland, D., Forsyth, K., Maciver, D., Walsh, M., Murray, R., Irvine, L., & Sikora, S. (2011). Key characteristics of knowledge transfer and exchange in healthcare: Integrative literature review. Journal of Advanced Nursing, 67(7), 1408–1425. doi:10.1111/j.1365-2648.2011.05631.x PMID:21466576 Plaice, C., & Kitch, P. (2003). Embedding knowledge management in the NHS south‐west: Pragmatic first steps for a practical concept. Health Information and Libraries Journal, 20(2), 75–85. doi:10.1046/ j.1471-1842.2003.00417.x PMID:12786906 Pourhamidi, M. (2013). Prioritisation of knowledge management strategies in the learning organisation: An integrated Shannons entropy-TOPSIS methodology. International Journal of Learning and Intellectual Capital, 10(3-4), 213–227. doi:10.1504/IJLIC.2013.057431 Pudjianto, B., Zo, H., Ciganek, A. P., & Rho, J. J. (2011). Determinants of e-government assimilation in Indonesia: An empirical investigation using a TOE framework. Asia Pacific Journal of Information Systems, 21(1), 49–80. Racherla, P., & Hu, C. (2008). eCRM system adoption by hospitality organizations: A technologyorganization-environment (TOE) framework. Journal of Hospitality & Leisure Marketing, 17(1-2), 30–58. doi:10.1080/10507050801978372

299

 Knowledge Management for Health Care and Long-Term Care

Resnick, H. E., & Alwan, M. (2010). Use of health information technology in home health and hospice agencies: United States, 2007. Journal of the American Medical Informatics Association, 17(4), 389–395. doi:10.1136/jamia.2010.005504 PMID:20595305 Röling, N. G., & Engel, P. G. (1990). Information technology from a knowledge system perspective: Concepts and issues. Knowledge, Technology & Policy, 3(3), 6–18. Rosli, K., Yeow, P. H., & Siew, E. G. (2012). Factors influencing audit technology acceptance by audit firms: A new I-TOE adoption framework. Journal of Accounting and Auditing, 2012, 1–11. Scott, S. D., Albrecht, L., OLeary, K., Ball, G. D., Hartling, L., Hofmeyer, A., & Thompson, D. (2012). Systematic review of knowledge translation strategies in the allied health professions. Implementation Science; IS, 7(1), 1–17. doi:10.1186/1748-5908-7-70 PMID:22831550 Scott, T., Mannion, R., Davies, H., & Marshall, M. (2003). The quantitative measurement of organizational culture in health care: A review of the available instruments. Health Services Research, 38(3), 923–945. doi:10.1111/1475-6773.00154 PMID:12822919 Sharp, D. (2003). Knowledge management today: Challenges and opportunities. Information Systems Management, 20(2), 32–37. doi:10.1201/1078/43204.20.2.20030301/41468.6 Shea, C. M., Jacobs, S. R., Esserman, D. A., Bruce, K., & Weiner, B. J. (2014). Organizational readiness for implementing change: A psychometric assessment of a new measure. Implementation Science; IS, 9(1), 1. doi:10.1186/1748-5908-9-7 PMID:24410955 Sheng, M. L., Chang, S. Y., Teo, T., & Lin, Y. F. (2013). Knowledge barriers, knowledge transfer, and innovation competitive advantage in healthcare settings. Management Decision, 51(3), 461–478. doi:10.1108/00251741311309607 Straus, S. E., Tetroe, J. M., & Graham, I. D. (2009). Defining knowledge translation. Canadian Medical Association Journal, 181(3-4), 165–168. doi:10.1503/cmaj.081229 PMID:19620273 Straus, S. E., Tetroe, J. M., & Graham, I. D. (2011). Knowledge translation is the use of knowledge in health care decision making. Journal of Clinical Epidemiology, 64(1), 6–10. doi:10.1016/j.jclinepi.2009.08.016 PMID:19926445 Sultan, N. (2014). Making use of cloud computing for healthcare provision: Opportunities and challenges. International Journal of Information Management, 34(2), 177–184. doi:10.1016/j.ijinfomgt.2013.12.011 Surve, M. B. A., & Natarajan, G. (2015). Knowledge Management Tools: Recognition for The Support To Healthcare Practitioners. International Journal of Advanced Information and Communication Technology, 1(12), 923–927. Szulanski, G., Ringov, D., & Jensen, R. J. (2016). Overcoming Stickiness: How the Timing of Knowledge Transfer Methods Affects Transfer Difficulty. Organization Science, 27(2), 304–322. doi:10.1287/ orsc.2016.1049

300

 Knowledge Management for Health Care and Long-Term Care

The Hong Kong Polytechnic University. (2008). Robotic hand responds to intention signals. Retrieved 20 July 2016, from https://www.polyu.edu.hk/ife/corp/upload/docs/8_publication/KT_Eng_2012/ pdf/06_4.pdf Tourangeau, A., Cranley, L., Spence Laschinger, H. K., & Pachis, J. (2010). Relationships among leadership practices, work environments, staff communication and outcomes in long‐term care. Journal of Nursing Management, 18(8), 1060–1072. doi:10.1111/j.1365-2834.2010.01125.x PMID:21073577 Unit, K. M. (2016). eKG Home Page. Retrieved 20 July 2016, from https://www.ekg.org.hk Voelker, K. E., Rakich, J. S., & French, G. R. (2001). The balanced scorecard in healthcare organizations: A performance measurement and strategic planning methodology. Hospital Topics, 79(3), 13–24. doi:10.1080/00185860109597908 PMID:11794940 Weiner, B., Amick, H., & Lee, S. Y. (2008). Conceptualization and measurement of organizational readiness for change: A review of the literature in health services research and other fields. Medical Care Research and Review, 65(4), 379–436. doi:10.1177/1077558708317802 PMID:18511812 Wilson, A. A. (2005). Impact of management development on nurse retention. Nursing Administration Quarterly, 29(2), 137–145. doi:10.1097/00006216-200504000-00008 PMID:15923977 World Health Organization. (2005a). World Health Organization Knowledge Management Strategy. Retrieved 20 July 2016, from http://www.who.int/kms/about/strategy/kms_strategy.pdf World Health Organization. (2005b). Knowledge Management in WHO: Bridging the Know–Do Gap. Retrieved 20 July 2016, from http://www.who.int/kms/en/kms_leaflet.pdf World Health Organization. (2016a). Knowledge management and health. Retrieved 20 July 2016, from http://www.who.int/kms/en/ World Health Organization. (2016b). WHO knowledge management strategy. Retrieved 20 July 2016, from http://www.who.int/kms/about/strategy/en/ Wu, L., & Kuo, Y. Z. (2012). A balanced scorecard approach in assessing IT value in healthcare sector: An empirical examination. Journal of Medical Systems, 36(6), 3583–3596. doi:10.100710916-0129834-2 PMID:22366918 Yao, W., Chu, C. H., & Li, Z. (2012). The adoption and implementation of RFID technologies in healthcare: A literature review. Journal of Medical Systems, 36(6), 3507–3525. doi:10.100710916-011-9789-8 PMID:22009254 Yun, E. K. (2013). Predictors of attitude and intention to use knowledge management system among Korean nurses. Nurse Education Today, 33(12), 1477–1481. doi:10.1016/j.nedt.2013.05.018 PMID:23806194 Zack, M., McKeen, J., & Singh, S. (2009). Knowledge management and organizational performance: An exploratory analysis. Journal of Knowledge Management, 13(6), 392–409. doi:10.1108/13673270910997088

301

 Knowledge Management for Health Care and Long-Term Care

KEY TERMS AND DEFINITIONS: Access Control: A procedure used to check if a user is permitted to enter a (computerized) system. Assistive Technology: Specialized hardware and software designed to improve the performance of individuals with disabilities. Best Practices: The best way to solve problems in organizations and be codified and stored in knowledge repositories. Clinical Decision: An outcome of a disease or injury process of diagnosis based on evidence, professional examination and judgement. Information Overload: When excessive amount of information are available, individuals may feel anxious as well as confused and have difficulty in absorbing them into proper workflow in managing related tasks. Knowledge Management System: An organization-wide information system that can capture, store, share and manage knowledge existed at individual, group and organizational levels. Knowledge Translation: A process to transform knowledge into practice or decision-making in workplace.

This research was previously published in Sustainable Health and Long-Term Care Solutions for an Aging Population edited by Ben Fong, Artie Ng, and Peter Yuen, pages 161-186, copyright year 2018 by Medical Information Science Reference (an imprint of IGI Global).

302

303

Chapter 16

Case Studies of Chronically Ill Children:

Implications for Education Professionals Thomas C. Gibbon Shippensburg University, USA

Kimberly Matthews Independent Researcher, USA

Christopher L. Schwilk Shippensburg University, USA

Katie Sweigart Shippensburg University, USA

Jenifer Cline Great Falls School District, USA

Emily Ferguson Independent Researcher, USA

David F. Bateman Shippensburg University, USA

ABSTRACT Medical advances have increased the number of children who have survived and are now living with chronic medical conditions (Irwin & Elam, 2011; Singer 2012). Diseases and conditions that as recently as a decade ago were considered fatal or completely debilitating are now increasingly treated as chronic conditions. Among these are several types of cancer, HIV/AIDS, respiratory illnesses, and severe epilepsy. Increasingly, students with severe chronic conditions are educated in public schools instead of home or hospital settings. The purpose of this chapter is to present case studies of real children and families that will allow educators and others a personal glimpse into the lives of children with chronic illness and their families. Suggestions for analyzing the case studies are provided that will help teachers, administrators, and teacher educators to examine the complex issues surrounding the educational needs of children with chronic illnesses.

DOI: 10.4018/978-1-5225-7122-3.ch016

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Case Studies of Chronically Ill Children

CASE STUDIES OF CHRONICALLY ILL CHILDREN: IMPLICATIONS FOR EDUCATION PROFESSIONALS The purpose of this chapter is to provide a brief historical overview of how children with chronic illnesses and their families have been served by educators, to track the development and application of legislation that pertains to chronically ill children, and to apply these ideas to four case studies of children with chronic illness. The treatment of children with chronic illnesses often mirrors that of children with other severe disabilities such as intellectual disabilities or autism. Early efforts at supporting these children generally took place in institutional settings where safety and medical treatment were the primary concerns. Additionally, families began to express interest in having their children educated in more inclusive settings. School districts, however, resisted these efforts to include students with disabilities and refused to accept them into public schools. As parents began to advocate and as legislation such as IDEA and later NCLB were enacted, children with chronic illness have been included more in the regular education setting. This chapter will describe the push and pull between those who believe that full inclusion is the best setting for students with chronic illness and those who believe that more restrictive settings are preferable. As the four case studies included here show, children with chronic illness and their families need to learn to adapt to serious medical conditions while attempting to live as normal a life as possible. Through no small measure of drive and resiliency, the children and their families show that it is possible to manage chronic illness, maintain a sense of humor, and pursue educational, social, and career goals. Readers of these case studies will be asked to apply information from the opening remarks in the chapter and their own experience through a series of questions. Medical advances have increased the number of children who have survived and are now living with chronic medical conditions (Irwin & Elam, 2011; Singer 2012). Diseases and conditions that as recently as a decade ago were considered fatal or completely debilitating are now increasingly treated as chronic conditions. Among these are several types of cancer, HIV/AIDS, respiratory illnesses, and severe epilepsy.

A Historical View of Legal Issues Pertaining to Students With Disabilities Since the 1960s, United States federal legislation has focused on educating children with disabilities. These laws were the direct result of parents advocating for their children, and in some cases, suing school districts and state departments of education to force schools to accept their children with disabilities into public schools. In 1972, the Pennsylvania Association for Retarded Children (now the Pennsylvania ARC) sued the Commonwealth of Pennsylvania for allowing its school districts to exclude students with moderate to severe cognitive delays from participation in school. Parents were told that the school had no ability to serve their children and went so far as to tell parents that school districts were not responsible to teach children who did not have the capacity to learn. After mere hours of testimony, the Commonwealth of PA conceded it had compulsory attendance laws, and the PARC Consent Decree was issued requiring schools to admit and serve students with intellectual disabilities. Following the PARC Consent Decree, parent groups across the United States pressured the federal government to mandate and fund special education as a basic right for all children with disabilities. In 1975, the Education of All Handicapped Children Act (EHA), also called Public Law 94-142, and later renamed the Individuals with Disabilities Education Act (IDEA), ensured that children and youth, ages birth through 21 with disabilities would have equal access to an education. Through this law, the

304

 Case Studies of Chronically Ill Children

federal government now offers grants to states to help support the direct services provided for children determined to be eligible under the law to receive a “free appropriate public education” (FAPE) in the general education environment. Although, a series of reauthorizations changed other provisions, the core principals remained the same. (Yell, 2015). In the United States, two federal laws that govern educational services, No Child Left Behind (NCLB) (2001), and The Individuals with Disabilities Education Act (IDEA) (2006) mandate children with disabilities be served in the least restrictive environment, but many schools are ill-prepared to manage severe chronic illnesses. IDEA requires students meet one of 13 different categories under which special education services can be provided. Other Health Impaired (OHI) is one of the categories; however, students in this category are more diverse than children in other categories such as those with learning disabilities or intellectual disabilities. In fact, the variety of medical conditions and the children’s individual experiences make them more unique. As a result, the eligibility for OHI is confusing even to special educators, and general educators are left wondering what the effect of childhood illness has on instruction, with the obvious exception that illness often causes frequent absences. Complicating the misunderstandings even further, many chronic diseases are “invisible” to the outsider. That is, the disease affects the individual, but other people may not be aware of the disease or understand how both the disease and the anticipation of recurring symptoms may affect the person’s ability to function. Further, some symptoms are episodic and the impact of the symptoms is misunderstood. For example, a student with asthma may from time to time have an attack that can be witnessed by school personnel and students, but few understand the impact of lower oxygen perfusion in the blood stream has on cognitive processing. Furthermore, when students “arrive” in a teacher’s classroom they arrive in the moment. Teachers generally have little knowledge of the child’s and the family’s experience. These experiences, however, are deeply ingrained in the child and influence nearly every aspect of life for the family. Those experiences include interactions on multiple levels and with multiple institutions, groups, and individuals including medical providers, social workers, early intervention providers, extended family members, and support groups comprised of other families dealing with the complexities of chronic illness. As education has advanced for students with chronic disabilities, regardless of where they were served in special education, the main responsibility for programming and teaching continued to fall on the special education teacher (Zigmond, Kloo, & Volonino, 2009). Nonetheless, placement options for students with chronic disabilities have changed. In the early days of special education, students were sometimes “mainstreamed” into general education classrooms. Under this model, the primary placement was the special education classroom and students “earned” the privilege of participating with their non-disabled peers by displaying appropriate behavior or demonstrating the ability to succeed academically without high levels of support. Later in the development of special education, mainstreaming gave way to the concept of inclusion. Under the inclusion model, instead of students with disabilities needing to earn their way into a general education classroom, students had the right to be placed in a general education classroom. Only when and if an evaluation determined that students required supports beyond those that could be delivered in the general education classroom, could children with disabilities be placed in more restrictive environments and then only to the extent that the placement was justified by the child’s IEP team (Friend & Bursuck, 2011). As it was, and still is practiced in some districts, inclusion means all students with disabilities, regardless of their disability condition or severity, be educated in the general education classroom (Mastropieri & Scruggs, 2010). Rather than having students go to a special location to receive support, any needed support would “come to them” in the general education classroom (Turnbull, Turnbull, Erwin, 305

 Case Studies of Chronically Ill Children

Soodak, & Shogren, 2010). For students with more severe disabilities, paraprofessional staff is often hired to provide more assistance (Mastropieri & Scruggs 2010). Perhaps the conceptual distinction made between mainstreaming, inclusion, and full inclusion is that those who support mainstreaming believe the student with a disability first belongs in special education and that mainstreaming occurs when the student is “ready” (Newberger, 1978). In direct contrast, proponents of full inclusion support a student with a disability (chronic or otherwise) should always begin in general education, with supports. Full inclusion advocates view the rights of students with disabilities to be fully integrated into regular education classes, even if it this placement is found to be socially, emotionally, and academically ineffective (Blackman, 1992). The federal regulations specifically state: §300.115 Continuum of alternative placements. (a) Each public agency must ensure that a continuum of alternative placements is available to meet the needs of children with disabilities for special education and related services. (b) The continuum required in paragraph (a) of this section must: include the alternative placements listed in the definition of special education under §300.38 (instruction in regular classes, special classes, special schools, home instruction, and instruction in hospitals and institutions); and make provision for supplementary services (such as resource room or itinerant instruction) to be provided in conjunction with regular class placement. (Authority: 20 U.S.C. 1412(a)(5)) So how do we place students with chronic disabilities now? The presumption is students with disabilities and other exceptionalities be educated in general education classrooms alongside their typically-learning peers, and provided with the necessary supports and services to meet their needs (Gargiulo & Metcalf, 2010). Students with disabilities are to participate fully, both academically and socially (Sailor, 2002). In addition, the general education teacher is expected to differentiate the methods used in the provision of services so all students will benefit from instruction. Only if every available method is tried in the general education classroom, and the needs of a student are still not met, should the student be pulled out for additional services (Voltz, Brazil, & Ford, 2001). This ‘pullout’ is when a student receives instruction in a setting away from the majority of their peers and is to be considered temporary. In other words, the special education teacher must strive to enable the student to go back into the general education classroom as soon as he or she is sufficiently academically prepared to render the general education classroom the most appropriate learning environment for that student. The most appropriate learning environment is the least restrictive where the student is able to receive educational benefit from the curriculum provided. There has been considerable debate surrounding the issue of where and how to educate students with disabilities. The disagreements have focused primarily on the extent to which students with disabilities should be educated in general education versus special education classes. There have been numerous articles, books, and conference proceedings highlighting the advantages and disadvantages

306

 Case Studies of Chronically Ill Children

of each (Kauffman & Hallahan, 1995; Lipsky & Gartner, 1997; Lloyd, Singh, & Repp, 1991; Stainback & Stainback, 1996). Proponents of full inclusion argue pulling out students from general education classrooms is ineffective; students are stigmatized, and the services are fragmented (Kennedy & Horn, 2004). Proponents of maintaining the continuum of services have discussed the lack of preparation of general education teachers, the potential of class resources, and that instruction is not individualized (Kauffman & Hallahan, 1995). Furthermore, the 1997 reauthorization of IDEA, reinforced by the No Child Left Behind Act (NCLB) in 2001 and then underscored in the 2004 reauthorization of IDEA, mandated students with disabilities fully participate in both state and school-wide assessment programs to increase accountability (Zigmond, Kloo, & Volonino, 2009). This is the ultimate goal of promoting grade level academic achievement on par with their non-disabled peers. Despite the mandate’s good intentions toward increasing accountability and raising expectations for students with disabilities, the added burden on general and special educators set the educational community in a tail spin toward trying to incorporate effective methods to differentiate instruction in the general education classroom while raising scores (Sindelar, McCray, Kiely, & Kamman, 2008).

The Benefits of Special Education Classrooms Both general and special education teachers, as well as parents, support maintaining special education classrooms on a continuum (Kaufman, Bantz, & McCullough, 2002) for some of the following reasons: 1. As implied with LRE legislation and supported by judicial decisions, general education classes are not individualized, and this setting often denies the uniqueness of the needs of certain students with disabilities. 2. Special education classrooms are often more structured than general education classrooms, and therefore students with disabilities have a greater chance for success and improved academic learning time. In addition, special education classes often highlight differentiated instructional approaches, varied curricular adaptations, more strategy instruction, and more cumulative review and practice (Fuchs & Fuchs, 1994). 3. Not all special education services can be provided in the general education classroom; and if they are, they may be stigmatizing, as noted by Mastroprieri and Scruggs (2010). It is important to remember that while IDEA can mandate the least restrictive environment, it cannot mandate acceptance (Smith, 2000). 4. General education teachers and staff are often not trained in how to work with and/or teach students with disabilities. Therefore, teachers often report they are not prepared (Sindelar, McCray, Kiely, & Kamman, 2008). Furthermore, many teachers report insufficient time to plan, design accommodations, or consult and collaborate with special education teachers (Scruggs and Mastroprieri, 1996). 5. If students with disabilities do not receive appropriate supports, they typically fall further behind their peers and may end up in special education after academic and social/emotional gaps have widened and are not as easily remediated (Scruggs & Mastropieri, 1996; Gerber, 1995).

307

 Case Studies of Chronically Ill Children

The Benefits of Participation in General Education Classrooms Although there is much support for maintaining special education classrooms as part of the continuum of services, there are also a number of drawbacks associated with removing student with disabilities from general education classrooms, including the following: 1. The general education classroom is where same age peers are educated; therefore, social, emotional, and academic equality are promoted for all students. 2. When appropriate support is provided, ALL students can benefit from inclusion. With so many diverse learners in today’s general education class, a general education teacher armed with better teaching tools will reach more non-disabled students as well (Sailor, 2002). 3. There are serious stigmas associated with the removal of students from the general education classroom, including possible ridicule (Stainback & Stainback, 1996). Others have discussed the stigma of not receiving adequate services in a pullout program (i.e., Morse, 1995). 4. When students leave the general education classroom to receive support, they often lose valuable instructional time. For example, if the student is “pulled out” for reading instruction during general education science content, this could be detrimental to their science knowledge. Although the ideal is for students who are receiving supplemental support to only be removed from the classes that they are unlikely to benefit from, this is often not actualized due to scheduling conflicts. 5. Piuma (1989) concluded the cost of providing an education in a segregated special education setting was doubled that of an integrated setting, though that should clearly not be a controlling factor. A similar study by Affleck, Madge, Adams, and Lowenbraun (1988) demonstrated that the integrated classroom for students with special needs was more cost-effective than the resource program, even though achievement in reading, math and language remained basically the same in the two service delivery models.

Homebound Instruction vs. Instruction Conducted in the Home Many public school districts confuse the differences between Homebound Instruction and Instruction in the Home. Homebound Instruction describes the instruction a school district or local educational agency may provide when a student has been excused from compulsory attendance due to temporary mental or physical illness or other urgent reasons. Homebound Instruction applies to all students – general education students, as well as students who receive special education services. The purpose of Homebound Instruction is to keep the student on track academically while the student is temporarily out of school. Homebound Instruction is school-supplied, one-to-one tutoring for a limited time. Homebound Instruction is not to be considered a special education placement. The important part of Homebound Instruction is it is for both general and special education students. Instruction Conducted in the Home is part of the definition of special education located in the federal regulations (34 CFR §300.39(a)(i)), and is recognized as a placement option on the continuum of alternative placements for students with disabilities (34 CFR §300.115). The use of Instruction Conducted in the Home is restricted to students whose needs require full-time special education services and programs outside of the school setting for the entire day. Ordinarily, these are students who, because of a severe medical condition or mobility impairment, are unable to leave home to attend school. Instruction

308

 Case Studies of Chronically Ill Children

Conducted in the Home is a placement determined only by the decision of an individualized education program (IEP) team.

Educational and Legal Impacts on Lives of Real People Understanding the issues related to the educational placement of students with disabilities is very important; however, one must always realize we are talking about individuals who are often leading very different lives than others, and therefore we need to remember the impact of our decisions on them. We offer four case studies to be read these as stories. The case studies are presented as accurately as oral and written histories permit. No attempt has been made to complicate the cases beyond their own inherent complexities, so that readers will not be left wondering, “is this real?”

Scope of the Case Studies The case studies include issues that are typical for parents and their children who live with chronic conditions. Teachers, researchers, students, and others examine these case studies from legal, familial system, or personal development perspectives. The legal implications relate to NCLB, IDEA, Section 504 of the Rehabilitation Act of 1973, and the Americans with Disabilities Act (ADA). There are many instances contained here that in retrospect highlight how the rights of children with chronic illness have not well protected. Each of the individuals discussed here could have filed litigation against their respective institutions. From a family systems perspective, considerations include family characteristics, interactions, and life cycle (Turnbull et al., 2006). Family systems theory looks at the family as a whole and considers such questions as: • • • •

Beside the child with a disability, what other pressing needs does the family have? What is the family structure? How emotionally healthy is the family? What general stage is the family?

All of these questions can be considered in the context of supporting the child or young adult with chronic illness. To consider the cases from an individual perspective, remember the normal processes of child and adolescent development. Children with chronic conditions generally do not have the same opportunities to develop as typically developing children. For example, consider social development. Typically developing children have social interactions with neighborhood children and school friends. Children with serious chronic illnesses are likely to be much more socially isolated; many of the primary social interactions these children have are with medical, educational, or other professionals. Teachers and their students may wish to address any number of these issues mentioned here. There are other perspectives from which to view these cases:

Britton’s Case •

Extended and repeated hospitalizations and medical personnel interactions.

309

 Case Studies of Chronically Ill Children

• • • • • •

Infant development. Late diagnosis of deafness. Effects on parents and siblings. Individual and family stress. Social isolation. Appropriate identification of primary disability.

Katie’s Case • • • • • • • •

Adult onset of disability. Social isolation. Loss of independence. Emotional implications of chronic illness. Interactions with the medical community. Developing informal support systems. College personnel interactions. Section 504 and ADA.

Kim’s Case • • • • • •

Extended and repeated hospitalization. Anxiety about prognosis. Teacher and administrator skepticism. Social isolation. Transition between schools. Self-advocacy.

Issues for Parents/Families • • • • • • • • • •

310

Stress from seeing child in pain. Feelings of vulnerability. Concerns of parents outliving the child and providing for long term support. Meeting the needs of siblings and spouse. Explaining health problems to others. Stress leading to relationship problems/divorce. Siblings concerns. Caregiver burnout. Medical and educational bureaucracy. Financial pressures.

 Case Studies of Chronically Ill Children

Issues for Students • • • •

Repeated hospitalizations. Stamina. Developing and maintaining friendships. Developing self-esteem and self-efficacy as a competent child, friend, learner.

School Issues • • • • •

Primary Diagnosis – OHI. Instruction in the Home vs. Homebound Instruction. Private consultants to provide homebound instruction. Teacher and administrator training Importance of transitions.

BRITTON: A COMPLEX CASE Britton was born in April 1987 in a small city hospital in the mid-Atlantic area of the United States. Britton was carried to full-term in an uneventful pregnancy. Her mother did not smoke, drink, or use caffeine or prescription or non-prescription medications. In fact, the first sign that something was wrong was that Britton was unable to keep milk down after being breast-fed. She would regurgitate all of the milk soon after feeding. Doctors performed x-rays and an upper GI exam and found that Britton did not have a fully developed stomach. The condition was known as microgastria. Fewer than 60 children have been diagnosed with this condition, and the outcome for nearly all was not good. Britton was fortunate in that she was transferred to a nationally recognized teaching hospital where doctors were able to construct an artificial stomach called a double lumen Roux-en-Y jejunal reservoir also known as a Hunt-Lawrence pouch. With the Hunt-Lawrence pouch, she was able to retain enough liquid to provide for her basic nutritional needs. She was fed through a naso-gastric (NG) tube. An additional outcome of the x-ray studies was that only one lung was visible. It became obvious that in addition to the absence of a real stomach, she also had only one lung on the left side. Further, her spleen was missing (aslpenia), and her heart was located predominantly on the right side of her chest (dextrocardia). The microgastria caused Britton to regurgitate and she often aspirated on her vomit causing damage to her trachea and introducing pneumonia-causing fluid to enter her lung. At two months of age, doctors conducted a bronchoscopy to evaluate the lung’s condition. As they advanced the scope into her trachea, they perforated her trachea with the probe, and as written in the doctor’s notes from that date, the doctors “visualized the heart.” In other words, they had punctured her trachea so severely that they could see her heart. At this point, the doctors left the operating room to talk to the parents. They asked the parents whether they should attempt to fix the trachea or allow her to pass away since her chances of living were so low. This was just one in a series of times when the doctors thought she would pass away before the end of the day. After this event, she was placed in the Pulmonary Intensive Care Unit (PICU) where she stayed for a week. They were told several times during the week that they should call in the family because Brit-

311

 Case Studies of Chronically Ill Children

ton would not survive. When she was stabilized, Britton returned to the Neonatal Intensive Care Unit (NICU). She was kept heavily sedated so she would not resist the ventilator. When Britton was six months old, a specialist was brought in from Colorado to dilate (i.e., place a stent) her airway. This improved her breathing and she began to show signs of increasing strength. Nonetheless, Britton stayed in the hospital for the first eleven months of her life fighting pneumonias and infections. Nearly eleven months after she was born, doctors decannulated (i.e., took the breathing tube out) and she began to breathe on her own for the first time since the trachea was torn. After eleven months, the doctors prepared Britton to be taken home. Few believed she would be able to stay there for long.

Arriving Home At home, Britton required around-the-clock nursing care to meet her breathing and nutritional needs. While remaining mostly at home, Britton had to go back and forth countless times to Philadelphia for emergency trips because of pneumonia. She was in and out of the hospital. She usually stayed in the hospital a minimum of two weeks at a time.

Feeding Issues Because of the microgastria, Britton had difficulty eating, and thus, was fed primarily through her nasalgastric tube. Nutrition was provided through high-calorie nutritional supplements (e.g., Pediasure, Mighty Shakes). Britton attended the feeding program at age three that was based on the principles of applied behavior analysis (ABA). Feeding did not go well. She aspirated into her lung frequently causing more pneumonia. Throughout her life, there have been numerous attempts to increase Britton’s tolerance of typical foods, but those attempts have met with very limited success.

Lung Disease At 14 months old, Britton went for a follow up appointment and her parents were informed at that point that an Auditory Brainstem Response test had been performed. At the appointment, an audiologist in a matter-of-fact manner told the parents that Britton was profoundly deaf. This was the family’s first knowledge of anything about deafness. They began a long struggle to learn about deafness and to decide on a communication method to use that would ultimately determine Britton’s educational experience. Specifically, her parents had to choose whether to teach Britton to communicate using sign language or to teach her speech-reading. They initially chose the oral/aural approach of speech-reading, but soon switched to learning sign language and teaching Britton the signs they learned. They began receiving services from an itinerant teacher of the deaf/hard of hearing and a speech language therapist who knew sign language. Britton’s ability to communicate quickly grew and surpassed her parents’ knowledge of and skill in sign language. Britton’s parents’ limited ability to communicate with Britton has caused difficulty throughout Britton’s life. In spite of her mother becoming fairly proficient in sign language, they often relied on deaf friends and proficient signers to explain complicated topics including health and safety and adolescent development.

312

 Case Studies of Chronically Ill Children

Education Britton’s progression through school was typical for a student with a hearing loss, but was interrupted by many illnesses and absences. At the age of three, Britton entered a public preschool for students with disabilities. The teacher did not know sign language, but Britton continued to receive itinerant services from a teacher of the deaf and hard of hearing. At age five, she entered a deaf and hard of hearing class operated by an educational consortium in the county. The class included Britton and four other students with hearing losses. The teacher used a sign system called Signed Exact English (SEE). SEE is not a language, but rather is a representation of English on the hands. Even though Britton’s educational placement was set, she was frequently absent for weeks at a time. During these absences, the school provided a teacher for homebound instruction, but there were often weeks where Britton received no instruction at all. To implement homebound instruction, the school had to wait seven to ten days to find a teacher to provide homebound instruction. That was complicated because teachers with skill in sign language were difficult to find. When the family moved to another city in Pennsylvania, the new school district recognized that deafness was not the primary impediment to Britton making educational progress. The primary disability was in fact her chronic illnesses. The district designated her primary disability in the category of “Other Health Impaired.” Using this category the district designated two alternating placements depending on Britton’s health condition at any point in time. When doctors determined that Britton was too ill or when her immune system was compromised, her placement as indicated in her IEP was “Instruction in the Home.” When her health was improved to the point where she could attend school, her placement was a deaf and hard of hearing support classroom. This innovative solution provided up to 20 hours of instruction in the home that was provided by a certified teacher of the deaf who came to wherever Britton was – home or hospital. Ultimately, Britton thrived academically with the instruction in the home, and that became her primary placement until she graduated from high school.

Family Issues Britton’s illness caused severe stress on the family. Britton’s father lost a high-paying job because of frequent absences to care for Britton. Because of this, the family experienced severe financial strain that created many disagreements and put strain on her parents’ marriage. When Britton’s mother became pregnant again, the nine months before their second daughter’s birth was filled with anxiety and fear. Britton’s sister was born without any birth anomalies, but Britton’s illnesses often required her sister to be cared for by relatives. Today, her sister loves Britton very much, but recognizes that she was affected by her parents’ need to attend to Britton more than her.

The Story in 2015 Britton was a child who was not expected to live. Today, she is married and has given birth to two beautiful boys. Her health issues continue to be a problem and she now is fed through her jejunostomy tube. She supplements her jejunostomy feedings with other liquid nutritional supplements. The only thing she really enjoys is cappuccino from a local convenience store. Her taste buds never developed fully, so her brain does not recognize taste in the same way that others do.

313

 Case Studies of Chronically Ill Children

Britton is not able to live independently. She is still small and at 27 years old only weighs 74 pounds. She has severe scoliosis, requires breathing treatments every four hours, and must be vigilant about not exposing herself to illnesses especially during cold and flu season. As a result, she stays home most of the time in the winter. Britton lives with her husband, children, and her mother and relies on her husband and mother for much of her and her boys’ care.

Questions for Reflection 1. What are the primary issues in this case? 2. Consider the typical developmental milestones that infants through 11 months go through. In what ways might an extended hospital stay during these particular months affect Britton and her family? 3. Similarly, in what ways do you think the diagnosis of deafness at age 14 months affected Britton? 4. For what reasons might Britton’s parents’ sign language skill have developed more slowly than Britton’s? What effects might this have had on Britton’s development? 5. Why was it so important for Britton to be reclassified as a student who could receive support under Other Health Impaired as described in IDEA? 6. Describe the ways that Britton’s condition affected the family. How would you describe her current support system?

KATIE’S STORY: BRAIN TUMOR AND EPILEPSY In August of 2007, when Katie was beginning her sophomore year in college, she was diagnosed with a brain tumor after having two tonic-clonic seizures. She took the semester off to have surgery to remove the tumor. After a biopsy, doctors found the tumor was benign and would likely not reoccur. Katie recovered well and was back at college the following semester. However, in the summer after her surgery, she started having “déjà vu” feelings. When mentioning these to her neurosurgeon during a check-up, he referred her to a neurologist. This was the start of what they diagnosed as simple-partial seizures. Over the next five years, specialists tried multiple medications to try to control the seizures. Doctors prescribed medications, but the medications did not help, had bad side effects, or made Katie’s seizures worse. There were “honeymoon periods” with a few new medications but those did not last long. Medications never completely controlled the seizures. In 2013, the seizures increased in frequency, duration, and intensity. She saw many specialists, but finally Johns Hopkins Hospital had the answers she was looking for. They recommended epilepsy removal surgery – a relatively new procedure in which the part of the temporal lobe of the brain is resected or cut away to remove a portion of the brain implicated in epileptic seizures. She stayed at Hopkins from November 14-November 23 to have these procedures. Katie is seizure-free today but still deals with the emotional, physical, social, and academic barriers epilepsy has given her. Socially, Katie felt left out of many activities. During college, she was sometimes too tired to join social events. She had difficulty completing her homework assignments and studying. The length of time it took her to finish her work often affected her social life too. She had to cancel many plans with friends due to fatigue and weakness. Katie was not driving during the six months after her last seizure, so she had to rely on friends for transportation. Not being able to drive was a challenge because she was required to go to field placements that were over 20 minutes away. Katie was afraid to go out in public

314

 Case Studies of Chronically Ill Children

because she feared having a seizure in front of others and/or getting physically sick from the seizure in front of others. She also could not move out on her own because of her inability to fully care for herself and not being able to drive. Katie had little independence during this time. She could not date and she found that even her family and friends had difficulty understanding her social isolation and emotional distress. Although she appeared healthy to others, her cognitive, emotional, and physical rehabilitation was very challenging. Emotionally, Katie experienced many barriers. With the initial surgery in 2007, her family did not have enough time to process what was happening before she had the surgery. It was overwhelming for Katie and for her family. Katie and her family received support from Katie’s friends in college, those in the community, and in their church, but she endured mild depression when back in college while trying to deal with classes and a social life. From 2008-2013, Katie saw many specialists for second, third, and fourth opinions. No one could answer questions about why she was losing weight, why the seizures were still occurring and becoming more intense, and why she was not feeling rested. Katie and her family were frustrated and frightened. Again, in the fall of 2013, with the surgery at Hopkins, Katie felt overwhelmed being able to process what was happening this time. She experienced another round of depression. She was not able to be the independent woman she wanted. She relied on her family and friends, she was isolated from her co-workers when working from home, and she was not able to drive.

Educational Impacts The surgeries and the tumor had a significant impact on Katie’s education. The tumor was located in the right temporal lobe near her hippocampus and amygdala. This affected her short-term memory. She had to work hard to remember names, directions, assignment requirements, information for assessments, and even to think of correct words when speaking – a language processing disorder known as mysnomia. Having taken off one semester and then coming back with a full class schedule, Katie did not have much time to adjust back into “real life.” Her lack of stamina and fatigue meant she had to go to bed early so she could get enough sleep. She had many long nights with insomnia. She often was not able to focus in class. She wished she could have extensions on bigger projects and her field experience hours for her education degree, but nobody from the college offered any academic help. She was never informed by her doctors or by university officials that she was eligible to receive support and accommodations from the disability services office at the university. The college never mentioned an accommodation plan known as a Section 504 plan and Katie’s family did not have the knowledge to ask those questions. Even faculty in the education program never mentioned the availability of accommodations to Katie. Studying for the PRAXIS teacher qualifying exam was one of the hardest events in her college career. Katie did graduate - summa cum laude - a semester later than expected with a B.S. in elementary education and a minor in music. She is now a fifth-grade teacher for a cyber charter school in Pennsylvania and has begun her master’s program in special education. Even today, she still has trouble concentrating, remembering information from time to time, and producing the correct words.

Questions for Reflection 1. What are the primary issues in this case?

315

 Case Studies of Chronically Ill Children

2. How does Katie’s adult diagnosis compare with Britton’s infant diagnosis of disability? What are the implications of the time frame for each? 3. Both the ADA and Section 504 state that reasonable accommodations must be made available to college students with disabilities and that no otherwise qualified individual can be discriminated against. How do you see these laws applying to Katie’s situation? What could she have expected the school to do? 4. What developmental issues are taking place in late adolescence? How can these be applied to what was going on in Katie’s life at this time? 5. How can institutions support the students with chronic illness who have related emotional issues and depression?

KIM’S STORY: ASTHMA, ALLERGIES, AND GASTRO-INTESTINAL ILLNESSES Kim was born in November 1976 in a city hospital in the mid-Atlantic region of the United States. She is the youngest of three children, with a family history of asthma, eczema, and cystic fibrosis. There have been many members of Kim’s family on her maternal grandfather’s side who have died of lung related issues - all before the age of thirty. Her mother did not smoke, drink, use caffeine, or use prescription or nonprescription drugs before or during her pregnancy. Kim was born four weeks premature at 5 pounds, 7 ounces. After delivery, Kim was diagnosed as having a high level of bilirubin, also known as jaundice, low body fat, and atopic dermatitis, also known as eczema. She was treated in the hospital for one week before being discharged to her home environment. Prior to the age of two, Kim was diagnosed with acute asthma and the prescribed inhaler medications to keep the disease under control. Kim hit all of the normal child development milestones, and attended pre-school at the age of four, making her ready to enter Kindergarten at the age of six. When Kim entered Kindergarten, the only medication she needed was her asthma inhaler. The school staff, especially the school nurse, knew that she had an asthma, but Kim was still required to obtain special permission to carry the inhaler, because it is a medication. During that first year of school, Kim became ill with asthma and eczema “flare ups.” One day during this year Kim learned about other triggers for her asthma when she ate a peanut butter filled donut. An acute asthma attack occurred, and her lips began to swell to three times their original size. She was taken to the hospital where it was determined she had a peanut allergy. She was then referred to an allergist, who performed allergy testing, and it was found that Kim had several environmental allergies, and allergies to peanuts and other nut products. From the age of six to the age of nine, Kim had several hospitalizations for asthma exacerbations, and missed many days of school. When Kim missed school, she was given schoolwork that was missed. Teachers required her to make up the work that was missed in the same amount of days that she was out of school. This worked for some time, but as her health began to decline, she began to need more time to complete her assignments due to longer absences. Her parents, doctors, and school all agreed that she would need homebound instruction as her grades were beginning to suffer. At the age of eight, Kim’s asthma became more severe, and therefore the medication Theophylline was introduced. This medication works as a bronchodilator by relaxing the muscles in the lungs and chest. Theophylline levels were monitored through blood levels to check for toxicity and to assess for correct dosing. If Kim’s blood levels were too low, then the medication was increased to keep her lung muscles

316

 Case Studies of Chronically Ill Children

relaxed. At one time, Kim had a seizure that was induced by high levels of Theophylline in the blood. The seizure was so severe, that she had to be induced into a coma for the seizing to cease. The prognosis at the time was unknown, especially since she had seized for a long period of time. Kim woke up from the coma with all her cognitive abilities intact. The doctors found that Kim’s body was not metabolizing the medication. The lack of metabolization resulted in dangerously high and toxic levels of theophylline. Doctors prescribed a nebulizer-breathing machine for her to use at home and during the school day. This was done because the rescue inhaler, which Kim needed special permission to carry in school because it was a medication, did not always work, and by the time her parents would get to her at school the asthma attack was at a crisis level, and she would have to be rushed to the emergency department of the hospital. Also, Kim had to have special permission to carry her inhaler with her in school because it was a medication. Unfortunately, the same bureaucratic red tape occurred when it came to the nebulizer. The school administers were resistant to having the nebulizer at school. They cited various types of liabilities such as, being responsible for the device, and having full access to the nurse’s office. In the end, the administrators allowed the nebulizer in the school so Kim could stay in school longer and avert severe attacks that would send her to the hospital. At the age of nine, Kim had a severe allergic reaction to an unknown food source while at a friend’s birthday party sleepover. After having an uneventful day, she woke up in her sleeping bag stuck to the material like it was glued to her body. Her parents were called to come to get her because she was ill. They then peeled her out of the bag, and took home where she was given a tar-bath, which was prescribed previously for her eczema issues. She was then taken to the hospital and admitted for 2½ months and treated like a burn patient after all of her skin fell off from the neck down due to the reaction. She was also placed on an elimination diet. With this diet she was not able to eat food for two weeks to give her body a rest, and only allowed to drink a nutrient-enriched beverage. They then introduced one food item at a time back into her diet, beginning with rice, which was eaten 3 times a day for 3-4 days, and then chicken, following the same protocol. During this time, Kim’s tutor would come to the hospital to complete assignments. This worked out well, as the school and the hospital were located in the same area. This made it easy for her teacher to have more flexibility with her schedule. Unfortunately, although there was a homebound instructor who saw Kim in the hospital setting, her attendance record and grades were still suffering due to lack of understanding by school personnel about the issues Kim was experiencing. Teachers and school personnel would often state to Kim that they too had asthma and/or eczema and were never in the hospital. Her parents often had to go to school and plead their case along with documentation from several doctors. During this particular admission, the building principal went to the hospital to visit Kim, and spent about 15-20 minutes speaking with her about what she was experiencing, and how she was coping. The principal met Kim’s mother on her way out of the room. The principal was in tears. The principal was in disbelief that asthma and eczema could be that bad, and apologized profusely for not coming sooner and she told Kim’s mother that they would be in touch. After that, the school showed more understanding and provided more flexibility with regard to assignments. At the age of 10, Kim was sent to Thomas Jefferson Hospital for rehabilitation for three months in the Asthma and Lung Disease Program. There, she was on lung-rest, and she was not allowed to leave the facility even to go home for visits. She attended the school program in the hospital, where there was a classroom and one teacher for all of the patients. The teacher communicated with her school in regards to the type of concepts and skills being learned, and she tried to keep her on the same track as

317

 Case Studies of Chronically Ill Children

her peers. During her three-month stay, she also learned that she had juvenile rheumatoid arthritis due to continuous steroid use that the doctors had prescribed to keep her lungs clear. When Kim entered middle school, the issues regarding her academic accommodations and modifications seemed to worsen. The school was in a building that had been converted from an old factory that has several floors and large amounts of dust. The building was under continuous reconstruction and the reconstruction created large amounts of dust. Due to Kim’s asthma and arthritic condition, it was very difficult for her to attend school. The decision was made for her to not attend school due to the construction. She missed 120 school days out of 180 in one year, but the school provided in-home tutors to try to keep her caught up in her studies. She also was excused from field trips because no one wanted to be responsible for an ill child, and her parents did not want to take the chance of her becoming ill so far away. During this time, Kim’s family and her doctors learned that Kim’s food allergies had become worse. They found that she could not eat beef and potatoes together. Eating them alone was fine, but eating them in combination with broccoli would send her to the hospital for an anaphylactic episode. When Kim entered high school, it brought about new complexities of navigating the school system. None of the records having information regarding her health status followed her to the school that was next door. High school brought new issues, as they were now dealing with class credits that would eventually accumulate towards a high school diploma. What seemed to be working in middle school did not work in high school. Two of the classes that gave Kim major problems in the beginning were physical education and biology. Every year students would have to run a mile and be timed. During her freshman year in the fall, Kim was instructed to run the mile, and she let the teacher know she could not run the mile, and that her environmental allergies were bothering her, making it even more difficult. The teacher insisted, and so Kim decided to walk the mile instead of run. Walking took the entire class period and she was left outside to complete the task. Her time was placed on the wall with the rest of her peers, and she was, of course, in last place. When the same task had to be completed the following year, she was presented with the same instruction, even after presenting again, why she could not run the mile. This time, she decided to listen to her teacher and run the mile. After completing the first quarter of the mile, she began to have an asthma attack so severe that an ambulance had to be called. Needless to say, she never had to run the mile again and was graded on the rest of her activities when appropriate. Biology class was enjoyable class for Kim until she had to complete labs associated with the material. How to make-up labs when Kim was absent due to illness was a recurring problem. The other problem was the dissection of animals. It was not so much the act of dissecting, but the chemicals involved in preserving the animals for the assignment. Kim was allergic to formaldehyde, which was the agent used to preserve the animals. The teachers never knew how to grade Kim, as this was a large part of her overall grade. Grading accommodations were a difficult concept for the staff, as they were not sure how to appropriately give grades for the credit of the class. It was decided that she would be graded on the work she completed, and the labs would only be included if they were something she was able to successfully complete without compromising her health. By Kim’s junior year, her health began to decline greatly, and she along with her family were told by doctors that she may not live past the age of 18. Her lung condition had been resistant to every medication on the market at that time, and the doctors were not sure what else could be done. At that time, Kim became very depressed, and would often discharge herself from the hospital when she was able to do so, stating she would not be compliant since it would not do any good.

318

 Case Studies of Chronically Ill Children

Kim did complete her schoolwork. At the beginning of her senior year, she had to have a fundoplication, which is an operation in which the stomach is moved up around the esophagus, and then placed there permanently. This was done because her sphincter muscle between her stomach and esophagus not working. She had complications from this surgery, resulting in the actual scar being re-opened and left open to heal. Due to all of these occurrences, Kim was not able to attend all of her tutoring sessions. She was informed by the end of the first marking period that she may not graduate from high school. One of the major turning points for Kim was her attitude she experienced on her 18th birthday. That day she woke up and decided that the doctors’ poor prognosis for her life was wrong, and so instead of preparing to die, she decided to begin to live. By the beginning of the third marking period, Kim caught up on all of her assignments, classes, and tests, and was on track to graduate with her classmates. In June 1995, Kim graduated from high school - proudly. Although it was an end to a very long chapter in her life, it was also the beginning of a series of learning experiences and growth. Kim attended college, and while that too provided difficulties, it also paved a way to learn self-advocacy that would be used throughout her life. After earning a Bachelor’s Degree, she then went on to earn a Master’s Degree in Education. Kim now works as a teacher in a children’s hospital where she teaches chronically ill children in the same hospital she “grew up” in as a child herself. Kim states, ” through all of the trials and tribulations she and her family experienced in requiring an education during her life, it was not done in vain. She said, “I am now able to be the teacher, advocate, facilitator, consultant, cheerleader, and friend to those experiencing life in a similar manner. I am to some the hope of what can be, but most of all to myself, I am the product of love, determination, and a will that never gives up.”

Questions for Reflection 1. What are the primary issues related to this case study? 2. What system can you suggest that would help with the transition from middle to high school? 3. What proof do families need to provide to school districts in order to be considered eligible for OHI services? What recourse do families have if school personnel do not believe the extent of the impairment? What can parents say to teachers who say things like: “I have asthma too and you don’t see me missing work so much.” 4. How much detail to administrators and teachers need to know about chronic medical conditions? 5. For Kim and others for whom doctors predicted premature death, what affects do you imagine that had on their psychological make up? How do you think it affected the parents?

EMILY’S CASE: FROM TEACHER TO THE MOTHER OF A CHILD WITH AUTISM Ten years ago, I was a third grade teacher preparing for IEP meetings. Today, I am a parent on the other side of the table. Getting to know and understand the needs of my “IEP students” required extra time and thought, but this effort always paid off during the IEP meetings. As a teacher, I understood that data, checking off lists, contacting families, etc. was very important, but I also believed that nothing replaced relationships. During each IEP meeting, I wanted the family to know that my top priority was to help their child achieve realistic, but yet, challenging goals. I also wanted them to clearly see that I cared about their child.

319

 Case Studies of Chronically Ill Children

My heart was never skipping with happiness over the thought of having to attend an IEP meeting. I never knew what I was going to get. Many questions would flood my mind: “Do I have the data and student work samples that I need? Will the guardian come to the meeting? Will the meeting be a flood of emotion or will it be stoic? Will my words be graceful or will they stumble in front of the audience of families, administration, and coworkers?” I had a high level of anxiety before each meeting, but the meetings always, and I mean always, ended well. The middle would sometimes get messy and at times, heated, but it would come together. You see from the first week of school on, I took notes about each of my students. I knew each one. I knew favorite colors and television shows. I knew when they skinned a knee or when a pet died. I would always look over this notecard before going to an IEP meeting and would be ready to share what I loved about their kid. Now, don’t get me wrong, I made sure I was 100 percent professional, but I also understood that being professional included being personal. I cared about my students and worked hard, and families appreciated this. Little did I know, but within 10 short years, I would be attending these meetings as a parent. My oldest child, Sammy, is eight years old. He has severe autism and is intellectually disabled. I see him as my child who loves giving me kisses, riding his bike on the Rails-to-Trails path, hiking at Cub Scout camp, splashing in the ocean, and giggling as I play with him in the yard. This kid is my world. He has my heart. Since my son was two, I have worked with therapists and teachers to help him achieve numerous goals. I have this pounding drive to help him. Helping my child has been a beautifully uplifting, but yet, heart wrenchingly crushing experience for me as a mother. I want nothing more than for Sammy to have the best life possible. I want him to develop more independence and achieve amazing, life changing goals. The IEP is a complicated, necessary mess for me as a parent. First of all, to get through the IEP process, I must push my emotions aside and see the facts. His teacher speaks with me about what skills need to be at the top of the priority list. We talk about the growth we have seen, as well as, the areas he is struggling with in the classroom and at home. I know that Sammy has specific, achievable goals. I appreciate the open communication I have with his teacher, and I like being included as a member of the IEP team before we even have the meeting. I read the IEP before the meeting and feel confident that all will go well. A couple of years ago, I decided that I wanted to come to the IEP meeting with snacks and drinks for everyone to enjoy while we read and discuss the needs of my child. This is my way of thanking his educational team. I experience anxiety before, during, and after IEP meetings. Questions flood my mind once again: “Is Sammy achieving goals? Is he connecting with staff and enjoying his educational experience? Is he being pushed to do his very best? Do I fully agree with the goals? Is this IEP a good fit for him?” Then, the more personal questions come: “Am I doing enough to help Sammy? Did he master a skill because we practiced it over and over again at home? Is he not making progress in this area because I didn’t put time and effort into helping him with this skill? Will I be able to continue to manage his extremely aggressive behaviors safely? Will he ever be able to use the iPad to communicate his thoughts and feelings? What must I do to remain a motivated and engaged member of his educational team day after day, year after year?” Nothing will ever prepare me for the emotions I feel while I read data or comb through his educational and behavioral health reports/tests. I have trained my eyes to see my child as simply a boy, not as an

320

 Case Studies of Chronically Ill Children

autistic boy. When I read the reports, I clearly see Sammy has severe autism and is a world apart from typical children his age. Seeing this in print opens up concerns and doubts I don’t want to face or feel. Honesty is necessary for growth to occur. His educational team must assess and make needed changes. It is all good, painful, but good. So, what would I say to the teacher I was 10 years ago? Keep doing what you are doing. Be professionally personal. Love and care about each student. Don’t be afraid to give, even when you don’t see results. Some skills take a long time to master, and right when you are about to give up hope, the child will run break through the wall you were trying to get him or her to climb. Failure isn’t always failure and a grand accomplishment is the sum of many little victories. Keep working. Keep learning. Keep connecting. This is what effective and meaningful teaching is about.

Questions for Reflection 1. 2. 3. 4. 5.

What are the primary issues related to this case study? What can you suggest that would help with the transition from a professional to that of a parent? What can we do to support parents more in as they work to navigate the education system? How much detail to administrators and teachers need to know about the characteristics of a disability? Sammy’s needs are potentially long term and very involved? How do you think this will affect the parents?

CONNECTING THE CASE THEMES While each of the cases presented here outline specific details that may pertain only to the individual described, there are several common themes that the cases share. These themes suggest interventions by teachers and administrators in order to improve student outcomes. One theme is social isolation. Children with chronic illness are much more likely to be socially isolated both within and outside the school system. The connection between social isolation, mental illness and behavior, and poor academic performance is well recognized in special education. School personnel need to be aware of this connection in particular for students with chronic illness; the IEP should reflect goals to counter social isolation. Another overlapping theme between the cases is family stress. Families cope with the ongoing demands of caring for their child with chronic illness, raising their other children, maintaining a marriage, and earning a living. Families deal with stress differently; some families have stronger cohesion and are therefore more likely to handle stress well. School personnel should recognize the signs of family stress and be prepared to recommend community support systems. Another important common theme between these cases is the need for communication between the various parts and levels of the educational system. As students move between instruction in and out of schools or between the general education classroom and the special education classroom, a structured system for tracking student progress and instruction is needed. As students move between grade levels and, perhaps more importantly, as they leave the public education system particular attention to transition is needed. Records need to follow or precede placements. Student and families need to be aware of their needs and advocate for themselves. Families need instruction and support to develop self-advocacy skills. A final connection between the cases is the definition of chronic. The needs of the children and families are ongoing. For most educational personnel our interaction with students and families is brief; we

321

 Case Studies of Chronically Ill Children

work with a student for a year or several years. Chronic illness is a long-term concern. School personnel need to remember that families have important information to share about their children. Families also need understanding and ideas about how to set up formal and informal supports.

SUMMARY Due to medical developments and educational practice, many more students with chronic medical conditions need increased educational interventions. The medical developments in lifesaving and life extending practice mean that children who a few years ago would likely not have survived long after birth now have a much-improved prognosis. Even though the children survive the initial crisis of diagnosis or birth trauma, there may be serious lingering medical issues. As the medical profession increased its proficiency in lifesaving practice the move toward inclusion developed in education. The inclusion movement is a culmination of parent and educator desires coupled with legal backing that extends to the 1970s that advocates including students with disabilities in the least restrictive environment. Parents of children with chronic conditions are, of course, protected by the same legislation and influenced by the same desire as children who have other types of disabilities. The difference and the challenge for families and educators is that children with chronic conditions can have fluid, acute, and episodic needs. These needs are educational, emotional, and medical. All these issues need to be addressed in increasingly complex IEPs, and all of which require a level of professional commitment that goes beyond what has traditionally been expected or required of educators.

REFERENCES Affleck, J. Q., Madge, S., Adams, A., & Lowenbraun, S. (1988). Integrated classroom versus resource model: Academic viability and effectiveness. Exceptional Children, 54(4), 339–348. PMID:3342820 Blackman, H. P. (1992). Surmounting the disability of isolation. School Administrator, 49(2), 28–29. Friend, M., & Bursuck, W. D. (2011). Including students with special needs: A practical guide for classroom teachers. Upper Saddle River, NJ: Merrill. Fuchs, D., & Fuchs, L. S. (1994). Inclusive school movement and the radicalization of special education reform. Exceptional Children, 60(4), 294–309. Garguilo, R. M., & Metcalf, D. (2010). Teaching in today’s inclusive classroom: A universal design for learning approach. Belmont, CA: Wadsworth. Gerber, M. M. (1995). Inclusion at the high-water mark? Some thoughts on Zigmond and Baker’s case studies of inclusive educational programs. The Journal of Special Education, 29(2), 181–191. doi:10.1177/002246699502900208 Individuals With Disabilities Education Improvement Act of 2004, 20 U.S.C. §§ 1400 et seq. (1997). Irwin, M., & Elam, M. (2011). Are we leaving children with chronic illness behind? Physical Disabilities: Education & Related Services, 30(2), 67–80.

322

 Case Studies of Chronically Ill Children

Irwin, M., & Elam, M. (2011). Are we leaving children with chronic illness behind? Physical Disabilities: Education & Related Services, 30(2), 67–80. Kauffman, J. M., Bantz, J., & McCullough, J. (2002). Separate and better: A special public school class for students with emotional and behavioral disorders. Exceptionality, 10(3), 149–170. doi:10.1207/ S15327035EX1003_1 Kauffman, J. M., & Hallahan, D. P. (Eds.). (1995). The illusion of full inclusion: A comprehensive critique of a current special education bandwagon. Austin, TX: Pro-Ed. Kennedy, C., & Horn, E. (Eds.). (2004). Including students with severe disabilities. Boston: Allyn and Bacon. Lipsky, D. K., & Gartner, A. (1991). Restructuring for quality. In J. W. Lloyd, A. C. Repp, & N. N. Singh (Eds.), The Regular Education Initiative: Alternative perspectives on concepts, issues, and models (pp. 43–56). Sycamore, IL: Sycamore. Lloyd, J. W., Singh, N. N., & Repp, A. C. (Eds.). (1991). The regular education initiative: Alternative perspectives on concepts, issues, and models. Sycamore, IL: Sycamore Publishing Company. Mastropieri, M. A., & Scruggs, T. E. (2010). The inclusive classroom: Strategies for effective differentiated instruction. Upper Saddle River, NJ: Merrill. Morse, W. C. (1995). Comments from a biased viewpoint. In J. M. Kauffman & D. P. Hallahan (Eds.), The illusion of full inclusion: A comprehensive critique of a current special education bandwagon (pp. 105–120). Austin, TX: Pro-Ed. Newberger, D. (1978). Situational socialization: An affective interaction component of the mainstreaming reintegration construct. The Journal of Special Education, 12(2), 1–8. doi:10.1177/002246697801200204 No Child Left Behind Act. 34 CFR Part 200 (2001). Piuma, M. F. (1989). Benefits and Costs of Integrating Students With Severe Disabilities Into Regular Public School Programs: A Study Summary of Money Well Spent. San Francisco: San Francisco State University. Sailor, W. (Ed.). (2002). Whole-school success and inclusive education: Building partnerships for learning, achievement, and accountability. New York: Teachers College Press. Sindelar, P. T., McCray, E. D., Kiely, M. T., & Kamman, M. (2008). The impact of No Child Left Behind on special education teacher supply and the preparation of the workforce. In T. E. Scruggs & M. A. Mastropieri (Eds.), Personnel preparation: Advances in learning and behavioral disabilities (Vol. 21, pp. 89–123). Bingley, UK: Emerald. doi:10.1016/S0735-004X(08)00004-9 Smith, M. G. (2000). Secondary teachers’ perceptions toward inclusion of students with severe disabilities. NASSP Bulletin, 84(613), 54–60. doi:10.1177/019263650008461309 Stainback, W., & Stainback, S. (Eds.). (1996). Controversial issues confronting special education: Divergent perspectives (2nd ed.). Boston: Allyn & Bacon.

323

 Case Studies of Chronically Ill Children

Stout, K. S. (2001). Special education inclusion. Wisconsin Education Association Council. Retrieved from http://www.weac.org/resource/june96/speced.htm The Individuals with Disabilities Education Improvement Act, 34 C.F.R. § 300 et seq. (2006). Turnbull, A., Turnbull, R., Erwin, E., Soodak, L., & Shogren, K. (2010). Families, Professionals, and Exceptionality. Upper Saddle River, NJ: Pearson. Voltz, D., Brazil, N., & Ford, A. (2001). What matters most in inclusive education: A practical guide for moving forward. Intervention in School and Clinic, 37(1), 23–30. doi:10.1177/105345120103700105 Yell, M. L. (2015). The law and special education. Upper Saddle River, NJ: Pearson. Zigmond, N., Kloo, A., & Volonino, V. (2009). What, Where, and How? Special Education in the Climate of Full Inclusion. Exceptionality, 17(4), 189–204. doi:10.1080/09362830903231986

This research was previously published in Challenges Surrounding the Education of Children with Chronic Diseases edited by Maria Gordon, pages 263-296, copyright year 2016 by Information Science Reference (an imprint of IGI Global).

324

Case Studies of Chronically Ill Children

APPENDIX: RESOURCES Allergies National Institute of Allergy and Infectious Diseases Part of the National Institutes of Health, NIAID is a clearinghouse for scientists conducting research on the diagnosis, treatment, and prevention of immunologic and allergic diseases.

Calgary Allergy Network A network devoted to providing practical information and resources to anyone dealing with asthma and allergies, particularly potentially life-threatening allergies.

American Academy of Allergy, Asthma and Immunology This site features a physician search referral engine, a media hub and a patient resource center.

The Allergy Report Sponsored by the American Academy of Allergy, and Immunology, this online publication bills itself as a manual for primary care health professionals.

Alzheimer’s Disease Alzheimer’s Disease Education and Referral Center Sponsored by the National Institutes of Health, the site lists NIH Alzheimer’s centers and provides links to fact sheets and federal resources. It also features a bibliographic database and a calendar of events related to Alzheimer’s.

The Alzheimer’s Association Comprised of a network of chapters, the Alzheimer’s Association is one of the largest voluntary organizations studying the disease and providing support to caregivers.

Alzheimer Europe This site, which provides resources on dementia, has been translated into eleven languages.

325

Case Studies of Chronically Ill Children

Arthritis The Arthritis Foundation This foundation connects users with events, treatments, research, advocacy and goods related to arthritis. A zip code search provides information on the nearest Foundation chapter.

Arthritis National Research Foundation A private foundation that funds researchers seeking to discover new knowledge for the prevention, treatment and cure of arthritis.

National Institute of Arthritis and Musculoskeletal and Skin Diseases Sponsored by the National Institutes of Health, this page offers news, events and fact sheets, plus information on patient enrollment in clinical trials.

Asthma Allies Against Asthma Sponsored by the Robert Wood Johnson Foundation, Allies Against Asthma is developing a resource bank on its site to provide easy access to experts, training materials and community resources. Site visitors can view video clips from AAA coalition members.

Asthma and Allergy Foundation of America (AAFA)* Founded in 1953, AAFA has a national network of 13 chapters and more than 120 educational support groups to provide community-based programs. Users can submit questions to the site’s “Ask the Allergist” feature, and books and materials can be ordered.

Allergy & Asthma Network Mothers of Asthmatics* A non-profit organization that uses advocacy, education, community outreach and research to work towards their goal of eliminating suffering and death caused by allergies and asthma.

American Academy of Allergy, Asthma and Immunology This site features a physician search referral engine, a media hub and a patient resource center.

326

Case Studies of Chronically Ill Children

Bipolar Disorder Bipolar Disorders Portal A community site that features book reviews, links to articles, resources and other Web sites about bipolar disorder.

Cerebral Palsy United Cerebral Palsy* A national organization with 114 affiliates in 41 states, UCP is one of the largest health charities in the United States serving more than 30,000 children and adults with disabilities and their families.

Chronic Bronchitis Chronic Bronchitis A site by the American Lung Association that features a section called “Living with lung disease.”

Chronic Bronchitis: Primary Care Management An article from the American Academy of Family Physicians.

Chronic Obstructive Pulmonary Disease The Chest Foundation of the American College of Chest Physicians* Established in 1996, this group creates educational programs, supports research and raises awareness regarding chest diseases and prevention.

MedLine Plus A portal-style page of information disease from the National Library of Medicine regarding chronic obstructive pulmonary. The site is sponsored by the National Institutes of Health.

Cirrhosis The USC Liver Transplant Program and Center for Liver Disease Sponsored by the University of Southern California, the site includes a patient’s guide to liver transplant surgery.

327

Case Studies of Chronically Ill Children

The PBC Foundation Support, research and information about Primary Biliary Cirrhosis.

The PBCers Organization Supported by the American Liver Foundation, this site has a variety of links to information and resources related to liver disease.

Depression National Depressive and Manic-Depressive Association Founded in 1986 and consisting of 275 chapters, NDMDA provides support and information for persons with depressive and manic-depressive illness, and their families.

Depression-Screeing.org Sponsored by the National Mental Health Association, this site has a confidential online test to indicate a user’s level of depression.

MedlinePlus -- Depression A portal-style page devoted to information about depression from the National Library of Medicine.

Developmental Disabilities Administration on Developmental Disabilities From the U.S. Department of Health and Human Services, the site features a clickable U.S. map, locating disability resources by state

Protection and Advocacy Home of the nationwide network of congressionally mandated, legally-based disability rights agencies.

Diabetes American Diabetes Association* News, recipes, tip of the day and resources to help users find local help.

328

Case Studies of Chronically Ill Children

Do Your Level Best From the NIH-sponsored National Institute of Diabetes and Digestive and Kidney Diseases, this page contains tips on how to take care of diabetes and how to prevent some of the serious problems that the disease can cause.

Emphysema American Lung Association -- Emphysema Topics include symptoms, treatment and prevention.

National Emphysema Foundation Founded in 1971, NEF strives to improve the quality of life of those with emphysema, asthma, and related diseases.

National Emphysema Treatment Trial From the National Institutes of Health, a page detailing the first multi-center clinical trial designed to determine the role, safety, and effectiveness of bilateral lung volume reduction surgery (LVRS) in the treatment of emphysema.

Endometriosis Endometriosis.org This site contains information about the video “Endometriosis: The Inside Story.”

The Endometriosis Association A non-profit, self-help group founded to disseminate information to women and girls with endometriosis.

Epilepsy Epilepsy Foundation Founded in 1968, this foundation has over 60 affiliate groups.

329

Case Studies of Chronically Ill Children

Glaucoma The Glaucoma Foundation This site includes a calendar of glaucoma-related events plus many other resources and features.

Glaucoma Research Foundation A voluntary health agency dedicated to protecting the sight and independence of people with glaucoma.

National Eye Institute A glaucoma site sponsored by the National Institutes of Health.

Hearing Impairment What Hearing Impairment Is A site sponsored by the Nemours Foundation, a nonprofit organization devoted to children’s health.

Deafness Research Foundation This group has launched a five-year public outreach and education program to ensure that Americans, especially children, will benefit from research breakthroughs and enjoy a lifetime of hearing.

Deafness and Family Communication Center A group that provides clinical services for deaf or hard-of-hearing children and adolescents, seeking to promote their mental health and well-being.

National Institute on Deafness and Other Communication Disorders A site sponsored by the National Institutes of Health.

Heart Disease American Heart Association National Center This AHA site includes risk assessment for heart attack and stroke, resources for advocates and scientists, and a “Heart and Stroke A-Z” guide.

330

Case Studies of Chronically Ill Children

Heart to Heart Volunteers A volunteer support program for heart patients and caregivers with an online newsletter.

National Heart, Lung and Blood Institute A site sponsored by the Department of Health and Human Services.

Hepatitis C Chronic Hepatitis C: Current Disease Management From the National Institutes of Health, this site offers resources for those suffering from hepatitis C.

Centers For Disease Control Sponsored by the National Center for Infectious Diseases, this site has information on hepatitis C and other diseases.

High Blood Pressure High Blood Pressure Sponsored by the American Heart Association, this site includes a chart to measure acceptable blood pressure levels.

High Blood Pressure -- AHA Another high blood pressure page from the AHA.

MEDLINEplus -- High Blood Pressure Sponsored by the American Library of Medicine.

Human Immunodeficiency Virus (HIV) HIV/AIDS Resource Center From the Journal of the American Medical Association, this site contains treatment reports, a library, and a “Best of the Net” section.

331

Case Studies of Chronically Ill Children

Project Inform An organization dedicated to providing reliable information about AIDS and its treatment since 1985.

AIDS Treatment Data Network This site includes a directory of clinical trials.

HIVinSite A site containing up-to-date information on treatment and clinical trials from the University of San Francisco.

Kidney Disease National Institute of Diabetes and Digestive and Kidney Diseases A site sponsored by the National Institutes of Health.

National Kidney Foundation Information on kidney disease for patients and doctors.

American Association of Kidney Patients For 30 years, this group has striven to help patients and their families cope with the emotional, physical and social impact of kidney failure.

Lou Gehrig’s Disease (Amyotrophic Lateral Sclerosis) Doctor’s Guide -- ALS Medical news and alerts, plus links to discussion and news groups.

ALS Assocation This site features a physician’s list to put patients in touch with specialists.

ALS Survivors Guide Guide offers resources and information for patients and caregivers.

332

Case Studies of Chronically Ill Children

Lupus Lupus Foundation of America This site includes a listing of chapters around the United States, plus links to online communities and news groups.

Systemic Lupus Erythematosus A site sponsored by the National Institutes of Health.

Living With Lupus Features support groups, diets and nutrition, and personal stories.

Lyme Disease Lyme Disease Foundation Winner of an award from the National Institutes of Health for increasing public awareness of Lyme Disease.

Lyme Disease Network A non-profit foundation focused on the prevention and treatment of Lyme disease. Includes links to support groups and a bulletin board for online discussion.

American Lyme Disease Association An association dedicated to the prevention, diagnosis, treatment and control of Lyme disease and other tick-borne infections.

Migraine Migraine Information Center A site from the Journal of the American Medical Association.

Migraine Awareness Group From the National Migraine Association, a site to support Migraine sufferers, their families, and coworkers.

333

Case Studies of Chronically Ill Children

Multiple Sclerosis MS MOMS A support group for women and mothers with MS.

National Multiple Sclerosis Society* An organization dedicated to providing accurate and timely information to people with MS, their families, and caregivers.

MS Support Forum A moderated all-day support group provided by MedSupport FSF International.

The Multiple Sclerosis Association of America An international non-profit charitable organization serving those with MS and their families.

Orthopedic Impairments Strategies for Teaching Students with Motor/Orthopedic Impairments Osteoporosis Osteoporosis Online This site features a calculator to test whether you are getting enough calcium.

Foundation for Osteoporosis Research and Education A non-profit resource center dedicated to preventing osteoporosis through research and education of the public and medical community. Includes educational videos.

Paralysis of the Extremities Christopher Reeve Paralysis Foundation A joint venture of the Christopher Reeve Foundation and the American Paralysis Foundation.

334

Case Studies of Chronically Ill Children

Parkinson’s Disease Parkinson’s Disease Foundation This site features news, “ask the expert”, and an email newsletter.

Awakenings An Internet forum for Parkinson’s patients and caregivers.

Parkinson’s Disease Caregiver Information A site from the National Parkinson Foundation.

Psoriasis National Psoriasis Foundation A charitable membership organization comprised of people who have psoriasis and psoriatic arthritis, their family members, friends, physicians, nurses, researchers and corporations.

Questions and Answers about Psoriasis A site from the National Institutes of Health.

Schizophrenia Schizophrenia.com An information and support center for schizophrenia.

National Alliance for Research on Schizophrenia and Depression Formed in 1986, the group calls itself “the largest non-government, donor-supported organization that distributes funds for brain disorder research.”

Schizophrenia A backgrounder from the National Institute of Mental Health.

Schizophrenia -- Your Complete Well-Connected Guide A guide produced by experts at Harvard Medical School and Massachusetts General Hospital.

335

Case Studies of Chronically Ill Children

Sinusitis Sinusitis Fact Sheet A site from the National Institute of Allergy and Infectious Diseases. MEDLINEplus -- Sinusitis

Stroke National Stroke Association A group dedicated to education, services and community-based activities in prevention, treatment, rehabilitation and recovery from strokes.

American Stroke Association Sponsored by the American Heart Association, this group provides resources for doctors, patients and their caregivers.

National Institute of Neurological Disorders and Stroke Sponsored by the National Institutes of Health, this site features news and resources, plus links to studies that are seeking patients.

Thyroid Condition American Thyroid Association Founded in 1923, ATA is a professional society of experts focused on research and treatment of thyroid pathophysiology.

Thyroid-Info A site for thyroid patients and advocates featuring a variety of news and information links.

FocusOnThyroid.com A commercial health and information site from MedicineNet.com.

336

Section 6

Diabetes

338

Chapter 17

Analyzing Online Social Support Within the Type 1 Diabetes Community Kristin G. Maki University at Buffalo (SUNY), USA Aisha K. O’Mally University at Buffalo (SUNY), USA

ABSTRACT Social support has been linked with many health outcomes, ranging from heart disease to depression. Although its importance has been recognized, less is known about how individuals with chronic illnesses may use social media to provide and seek social support. This chapter’s focus is on the way in which people with Type 1 diabetes (T1D) use social media to provide and solicit social support. A mixedmethods approach is utilized. First, posts from two social media platforms were qualitatively content analyzed. Second, the data were quantitatively analyzed to provide a finer-grained understanding of the messages. The results show informational support as the most prevalent on both sites, although there are some differences in content and use. This chapter’s implications highlight the importance of social media as a conduit for social support among caregivers and individuals affected by T1D.

INTRODUCTION Social support has been studied and defined in a number of ways. In general, social support is reflected as receiving help, comfort, or information from other people (Wallston, Alagna, DeVellis, & DeVellis, 1983). Previous research has established a link between social support and health outcomes for patients with chronic illnesses (e.g., Gallant, 2003). Sources of social support typically include family members, friends, and members of one’s community. As can be expected, individuals may receive different types of social support from each source (e.g., Wallston et al., 1983). In turn, the relative importance of each source may vary across one’s lifespan (e.g., Heinze, Kruger, Reischl, Cupal, & Zimmerman, 2015). For instance, in a community-based survey of adults living in Michigan, researchers found better emotional DOI: 10.4018/978-1-5225-7122-3.ch017

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Analyzing Online Social Support Within the Type 1 Diabetes Community

health among young adults who received social support from their family members. In contrast, support from one’s community and friends was related to better emotional health for older adults (Heinze et al., 2015). In addition to age-based differences in social support’s impact, individuals with a chronic illness may reap the most benefit from disease-specific support (e.g., Aalto, Uutela, & Aro, 1997). For instance, participants who reported diabetes-specific psychosocial factors also reported better well-being in perceived health and mental health (Aalto et al., 1997). Likewise, another study examining the effects of perceived and utilized social support on diabetes control found that both were significantly related to patient outcomes. Specifically, participants who perceived and used their social support sources showed good control of their diabetes (Fukunishi, Horikawa, Yamazaki, Shirasaka, Kanno, & Akimoto, 1998). One explanation could be that patients with a chronic illness desire a community in which to discuss their illness, provide clinical information, and receive support for their treatment (Greene, Choudhry, Kibuk, & Shrank, 2010). Further, in a review of six controlled diabetes intervention studies, researchers found that receiving the right amount of social support from varied sources is important for diabetes patients (van Dam, van der Horst, Knoops, Ryck, Crebolder, & van den Borne, 2005). The present research builds on these findings and applies it within an online setting. Specifically, this chapter discusses findings from a content analysis of two social media platforms centered on providing support and information for people with Type 1 diabetes (T1D) as well as their family members and caregivers. The messages included in the present study illustrate both action-facilitating and nurturing support, both of which are important from a communication standpoint (du Pré, 2005). This chapter’s aims are three-fold: 1) provide an overview of the relevant literature and theoretical framework; 2) introduce the studies’ methodology and results; and 3) discuss the contributions and future implications of this research.

BACKGROUND Social Support Over time, many dimensions of social support have been identified and discussed (e.g., House, 1981; House & Kahn, 1985). Using a communication scholar’s lens, however, social support is built on two pillars: action-facilitating support and nurturing support (du Pré, 2005). To summarize, action-facilitating support consists of instrumental and informational support. Instrumental support refers to tangible or material support to help with specific situations or merely as an act of affirmation (Taylor, Klein, Gruenewald, Gurung, & Fernandes-Taylor, 2003). Informational support can also involve a range of interactions-varying from suggesting a new restaurant for a friend to try to making referrals for helping agencies, such as job placement firms--to other individuals as they adjust to major transitory periods of life (Chen & Choi, 2011). In contrast, nurturing support involves emotional support such as acceptance, caring, and encouragement. A sense of belonging is also incorporated with nurturing support (du Pré, 2005). In a review of family communication behavior’s effect on patients with chronic illnesses, Rosland, Heisler, and Piette (2012) found varied outcomes. For instance, attentive reactions, emphasizing selfreliance and achievement, and cohesiveness among the family were related with more positive health outcomes. In contrast, critical, controlling, distracting, and overprotective actions from family members were related to negative outcomes among the patients (Rosland et al., 2012). Similarly, parental interac339

 Analyzing Online Social Support Within the Type 1 Diabetes Community

tions and friends’ influence were associated with treatment adherence among adolescent T1D patients (Kyngäs, Hentinen, & Barlow, 1998). Specifically, treatment adherence was better for those who perceived their parents’ interactions as accepting or if their friends either altered behavior to fit with diabetic treatment or diabetic treatment did not interfere with the time they spent together. In contrast, among the individuals who felt their friends had a good deal of influence, and who felt like incorporating T1D treatment did not fit with their friends’ lifestyle, adherence was poorer (Kyngäs et al., 1998). Likewise, in examining spousal influence on diabetes management among patients with Type 2 diabetes, one study found spousal undermining as a factor in poor treatment adherence (Henry, Rook, Stephens, & Franks, 2013). Specifically, undermining included temptations to eat non-allowed food, indicating disregard for the spouse’s diabetic diet, and indicating lack of care whether the spouse followed his or her specified diet. Although this type of undermining was rare, occurring in only about one-third of the respondents, it was associated with higher blood glucose levels compared with those whose spouses did not undermine dietary restrictions (Henry et al., 2013). Despite these disparate findings, social support is typically associated with positive health outcomes for patients with diabetes. For instance, in a secondary analysis of a randomized trial of a guided diabetes peer support intervention, researchers found improved hemoglobin A1c (HbA1c) levels—indicating better glycemic control for approximately three months—among patients who engaged in a greater number of peer calls. The impact was most significant for patients who had lower levels of support otherwise, or lower literacy levels (Piette, Resnicow, Choi, & Heisler, 2013).

Social Media and Health Communication A recently published review of 348 peer-reviewed research articles examining technology in health communication showed social support as one of this interaction type’s top uses (Hu, 2015). Although some disadvantages of online support groups were seen—such as short-term group membership—the findings suggest an overall positive effect (Hu, 2015). Likewise, in examining the ways that individuals use health video blogs (vlogs) as a form of social support, Huh and colleagues (2014) found users engaging in this form of communication for several reasons. Specifically, in their content analysis of 72 vlogs posted on YouTube--as well as 1,274 comments posted on the vlogs--the researchers categorized users’ purposes into four categories: 1) journaling for self-reflection, documentation, or updates; 2) helping others through education, encouragement, and inspiration; 3) responding to others; and 4) entertainment. The analysis included vlogs from individuals with cancer, HIV, and diabetes. For those with diabetes, the purpose was mostly action-facilitating support as evidenced by sharing tangible tips and strategies relating to blood glucose management (Huh, Liu, Neogi, Inkpen, & Pratt, 2014). This aligns with prior research on cancer patients’ uses of online social support groups. Specifically, in a review of 10 research studies’ results, information seeking and giving were prominent activities within many of the groups (Klemm, Bunnell, Cullen, Soneji, Gibbons & Holecek, 2003). Similarly, an examination of online communication between healthcare providers (HCPs) and Native American diabetes patients suggests that patients are more likely to log in to a Web portal when their HCPs send personal messages. Going a step further, the messages that are positively related to online activity among patients include informational support, emotional support, and tangible technical help (Robinson, Turner, Levine, & Tian, 2011). Finally, in examining computer-mediated social support (CMSS) among Korean diabetes patients, Oh and Lee (2012) found that higher levels of online community activity were positively related to perceived CMSS levels. Specifically, the index including duration of online com340

 Analyzing Online Social Support Within the Type 1 Diabetes Community

munity membership, time spent in the community, frequency of visiting the online community, and the number of members contacted by patients within the community (Oh & Lee, 2012). Further, there has been an increase in online groups and pages that are specific to patients and caregivers who are dealing with a disease or chronic illness (e.g., Klemm & Wheeler, 2005; Sarasohn-Kahn, 2008; Shapiro, 2009). As suggested by Roblin (2011), Web 2.0 and related technology offer the ability to form social networks to offer support that aligns with needs outlined by the chronic care model. Specifically, the technology offered through Web 2.0 allows patients the opportunity to interact with others through sharing information, collaborating, and actively participating in communicative interactions. Moreover, the flexibility offered by Web 2.0 and similar technology interfaces may make it easier for patients with a chronic illness to receive support for their self-care (Roblin, 2011). Importantly, social support that is offered online empowers patients and caregivers to seek and receive information and other types of support they desire (e.g., Klemm & Wheeler, 2005). One reason may be due to the ease with which participants in an online support group can exchange information about their experiences. For instance, Klemm and Wheeler (2005) note that talking about a particular problem or setback can often be met with a flood of responses from others who provided advice or comfort based on similar occurrences. In a diabetes-specific examination of online social support, Greene and colleagues (2011) content analyzed 690 comments from wall posts and discussion topics from 15 Facebook groups with the largest following. The sample included 15 of the newest posts from the groups. It also included 15 discussion topics from the top 10 groups. The findings from Greene and colleagues’ (2011) qualitative study suggest that friends, family members, and diabetes patients use Facebook to share and receive emotional support and disease-specific information. Specifically, about one-third of the posts were coded as an attempt at providing emotional support. A lower proportion of posts (13%) were responding to requests for clinical information (Greene et al., 2011). This chapter builds upon the previously detailed findings to further understanding of how patients with T1D use social media to provide and receive social support.

SOCIAL SUPPORT ENACTED THROUGH SOCIAL MEDIA Online Social Support Relating to Chronic Illness As previously discussed, individuals who are affected by a disease or chronic illness may benefit from online social support (e.g., Klemm & Wheeler, 2005). Although the links between social support and health have been well-established (e.g., Reblin & Uchino, 2008; Strine, Chapman, Balluz, & Mokdad, 2008; Uchino, Cacioppo, & Kiecolt-Glaser, 1996), less is known about how social support is given and received in online settings. Recently published results from a content analysis of posts on Twitter (i.e., “tweets”) with the hashtag “#Stupidcancer,” suggest that emotional and informational support is enacted within online communities (Myrick, Holton, Himelboim & Love, 2016). However, similar to prior research focusing on online cancer-related social support (e.g., Klemm et al., 2003), Myrick and colleagues’ (2016) findings showed a majority of tweets fell into the information sharing category. Further, the study’s findings showed that negative emotional expressions in the tweets were associated with few shares whereas positive emotions were linked with message sharing (Myrick et al., 2016). This finding supports prior research that connects positive emotional content with message sharing (e.g., Berger & Milkman, 2012). Despite the information gained by Myrick et al.’s (2016) findings along with other 341

 Analyzing Online Social Support Within the Type 1 Diabetes Community

scholars’ work, a void remains regarding the ways in which caregivers and T1D patients utilize social media for social support. Another issue relating to online social support is the formation of communities. For instance, an analysis of online communities formed by breast and prostate cancer patients suggests that individuals formed relationships unlike those typically seen in a one-to-many communication setting (Himelboim & Han, 2014). More specifically, in their social networks analysis of Twitter communities surrounding breast and prostate cancer patients, Himelboim and Han (2014) found dense clusters of users who had followed a central information source. Interestingly, although there are many accounts on Twitter that focus on health and news, these organizations did not influence the dense hubs (Himelboim & Han, 2014). Instead, the cluster of users who remained constant over time included individuals’ and small websites’ sources more frequently than sporadic users. Conversely, the sporadic users who mentioned breast or prostate cancer in passing relayed information from larger institutions such as the American Cancer Society (Himelboim & Han, 2014). The study also found differences based on the type of cancer. Specifically, the core community on Twitter for prostate cancer was smaller than the breast cancer community. Gender may partly explain this finding, but additional research is needed to further parse out differences in social media use based on health conditions (Himelboim & Han, 2014).

Social Media Platform Differences Prior research has suggested personality differences may influence preferences for social media platforms. Specifically, those who possess traits such as extraversion and openness to experience may be more likely to use Facebook or other social network sites (e.g., Correa, Hinsley & De Zúñiga, 2010; Hughes, Rowe, Batey & Lee, 2012). Moreover, individual traits may influence individuals’ uses of these sites. For instance, one study’s findings showed that individuals who scored higher on extraversion belonged to significantly more Facebook groups than others in the study (Ross, Orr, Sisic, Arseneault, Simmering & Orr, 2009). Similarly, Hughes and colleagues (2012) found personality differences predicted preferences for Twitter and Facebook use among individuals. Specifically, this study’s findings suggest that individuals who scored higher in neuroticism were more likely to use Facebook as a channel for social contact. In contrast, informational use of Twitter was related to higher levels of need for cognition. One reason for this may be due to the utilitarianism afforded by Twitter’s breadth of information without the requirement of socializing (Hughes et al., 2012). Based on the varied individual-level traits associated with social platform use as well as the sites’ affordances, the present study aims to add to the literature on platform-based differences. Specifically, this chapter’s discussion centers on differences seen in social support exchanges on two popular social networking sites: Facebook and Twitter.

SOLUTIONS AND RECOMMENDATIONS In order to redress the void discussed previously, this chapter presents results from a comparative content analysis of messages from two social media platforms: 1) Twitter posts with the hashtag “T1D,” and 2) posts from one of the largest public Facebook pages that focuses on T1D support and information. Based on the previously discussed literature, the present study posed four research questions. 342

 Analyzing Online Social Support Within the Type 1 Diabetes Community

RQ1: What kinds of social support do people affected by T1D seek and receive through social media platforms? RQ2: Which type of social support do people affected by T1D engage in most frequently on social media platforms? RQ3: What type of messages engage users on social media platforms focusing on T1D? RQ4: Is there a difference in the uses of Facebook and Twitter among individuals affected by T1D?

Method First, a sample of posts (N = 502) posts from a public support and information page for people who are affected with T1D on Facebook were retrieved with R’s (version 3.2.5) “facebook” library. The Facebook page has a large group of followers, with more than 24,000 followers when the posts were retrieved. Because the range of users is smaller and the content more focused (e.g., Hughes et al, 2012), a sample of 500 was deemed sufficient. Second, a sample of tweets (N = 1,000) with the “#T1D” hashtag were retrieved with R (version 3.2.5) and its “twitteR” library. The hashtag was chosen due to its specificity in differentiating T1D and T2D communities. Based on the research focus of this study, the decision to use a specific hashtag allowed the sample to center upon T1D rather than diabetes in general. The decision to retrieve 1,000 tweets was made due to the potential wide span of users (both individuals and organizations) that may utilize this hashtag as well as the known potential of spam (e.g., Yardi, Romero & Schoenebeck, 2009), as well as posts that may not be able to be analyzed due to language barriers (e.g., Ciot, Sonderegger, & Ruths, 2013) or expired content (e.g., Chang, Pimentel & Svistunov, 2011). Both samples were retrieved within 24 hours of one another and include posts from November and December 2016 in order to minimize possible time effects. This method allows a comparison to be made between T1D-related social support that was enacted on two popular social media platforms.

Procedure To determine the specific message topics that were included in the Facebook posts, two coders began analyzing with the scheme developed by Robinson, Turner, Levine, and Tian (2011). The original use of this coding scheme was with analyzing patient-health care provider interaction on a Web-based diabetes monitoring system (Robinson et al., 2011). In its initial use, researchers developed the coding scheme to examine the types of communication and social support messages that were enacted in these Web-based exchanges between diabetes patients and their health care providers (Robinson et al., 2011). This coding scheme was selected due to its prior use and overlap with the current study. In the present study, the two coders independently examined all responses for specific message nuances that were not captured with the scheme introduced by Robinson et al. (2011) and inductively coded for salient message topics. Next, independent lists of topics were discussed and compared to produce a final list of eight categories with thematic sub-categories. The final codebook captured the message topics as well as the essence of the participants’ posts on Facebook. Throughout the process, the coders independently analyzed responses, then met after every 100 posts to discuss coding discrepancies and continue refining the codebook’s rules until 100% agreement was reached. The same process was

343

 Analyzing Online Social Support Within the Type 1 Diabetes Community

undertaken with the sample of data that were collected from Twitter. During this process, two additional coding categories emerged. Thus, a total of 10 message coding categories were implemented with the present study. The categories are described below and include: (1) information, (2) emotion, (3) tangible, (4) request for information, (5) technical, (6) fun/humor, (7) call to action, (8) miscellaneous, (9) spam, and (10) snake oil.

Information The first message category was information. The posts represented within this category provided information of several types about T1D. Specifically, four subcategories emerged from the data: (1) diabetes medication and/or tool-related (e.g., insulin pricing, new diabetic products); (2) diabetes-related holiday/ celebration (e.g., November is National Diabetes Month); (3) facts about T1D; and (4) T1D social facts (i.e., information about the T1D community, information about individuals’ T1D diagnosis, or posts that centered on experiences that are common for individuals who are affected by T1D).

Emotional The second category was emotion, which represented posts that provided or requested some level of emotional support related to managing T1D. These posts could be written from the perspective of the person with T1D, caregiver, family members, or friends. In sum, six subcategories emerged from the data: (1) provision, (2) direct solicitation, (3) implicit solicitation, (4) description of support, (5) esteem, and (6) inspirational. In the first subcategory, posts that offered emotional support to other individuals were coded as provision. Second, direct solicitation was seen with individuals who overtly asked for emotional support. Third, implicit solicitation was seen in messages in which an individual described a traumatic or trying situation related to diabetes. This type of post was often met with sympathetic replies or other offerings of social support, thus implicit solicitation emerged. Fourth, messages that described support the individuals had received relating to T1D were included with this category. It is important to note that these posts could either be made by the person who has T1D or their caregiver(s), friend(s), or family members. Fifth, esteem messages centered on an individual with T1D or their caregiver(s), friend(s), and/or family member(s) describing how well they do handling T1D. This may be conceptually similar to patting oneself on the back. The sixth and final emotional subcategory, inspirational, included messages that were coded as having the intent of eliciting hope and encouragement for other people who are dealing with T1D.

Tangible The third category of messages was described as being tangible. Much like tangible social support, these posts offer or provide physical help towards managing T1D. These messages were most frequently related to emergency situations (e.g. offering medication or diabetic tools to aid individuals with T1D in the face of a natural disaster, such as hurricanes or flooding). No subcategories emerged from the data within this category.

344

 Analyzing Online Social Support Within the Type 1 Diabetes Community

Request Information The fourth category was requesting information. This type of message specifically asked others for contact or medical information related to their T1D experience (e.g., symptoms, side effects, or opinions on diabetic tools).

Technical This category was represented by posts that requested help with maneuvering through the Facebook page. An additional function of technical messages was to remind users of the rules and protocol for posting on the page. None of the messages in the Twitter data included content that fit this category.

Fun/Humor The sixth category was fun/humor. This category is represented by posts that utilize humor and encouraged light heartedness towards handling T1D and the daily frustrations living with a chronic illness.

Call to Action The seventh category was call to action. This is represented by posts that make a request for others to perform a task related to T1D (e.g. wearing blue for T1D, or changing a profile picture to represent T1D). Additional topics that were included within call to action were posts that asked the audience to follow-up with some other action, such as contacting political representatives about the financial burden of T1D.

Miscellaneous The final category was miscellaneous which represented all posts that did not fit any category. Messages that did not relate to T1D were also included in this category. The same eight categories were used to analyze the messages included with the sample of “#T1D” tweets. However, two new categories emerged that were necessary to capture the nature of the data. These types of messages did not exist in the initial coding scheme that was honed with Facebook posts; the additional categories included with the Twitter data are described as “spam” and “snake oil.”

Spam This category is represented by the posts that resemble “junk mail.” Specifically, the information in the posts coded as spam tended to lead to sites that did not directly relate to T1D. Moreover, many of the messages that were coded as spam had the intention of selling items, such as books and other products that were posted on eBay and other online marketplaces.

345

 Analyzing Online Social Support Within the Type 1 Diabetes Community

Snake Oil This category is represented by posts in which the author makes claims about curing T1D through alternative methods, such as diet and exercise. Although these methods may help with T2D, they do not have similar effects on individuals diagnosed with T1D (e.g., Global Diabetes Community, 2016). Prior to the analysis, control variables were created for the messages’ content types. This was completed by creating dummy codes for the message characteristics. Specifically, four dummy variables were created in the Facebook dataset: (1) photo, (2) status, (3) video, and (4) link, with “event” serving as the comparison. There were two control variables that were included in the Twitter dataset: (1) if the post was made in reply to another user’s screenname, and (2) if the post was a “retweet,” which indicates that the user who posted the message was not its originator.

RESULTS Research Question 1 First, summary statistics for all categories were conducted (see Table 1) to address RQ1, which asks what kinds of social support people who are affected by T1D seek and receive through social media platforms. The present study’s findings show that most of the Facebook posts provided some level of information (72.5%) and social facts (58.4%). Emotion (29.7%) was also present within almost one-third of the Facebook posts. Additional categories outside of social support that were identified included request for information (30.7%) and call to action (15.5%). Similarly, the tweets were most prominently focused on information (35.1%). Social facts (21.1%) and emotion (21.1%) were also represented equally within the sample. Spam posts were prevalent (42.4%) within the sample and excluded from further analyses. Posts that were not in English (n = 160), coded as snake oil (n = 30), or unavailable (n = 46) were also excluded from the analysis. Thus, the final sample size for the Twitter data was reduced (final n = 342). A summary of the Twitter data is included in Table 2.

Research Question 2 In order to address RQ2, which asks if the types of social support seen in social media posts for people with T1D differ in frequency, a series of chi-square tests of independence were performed. In the first, the frequencies of the two most prevalent, distinct categories (i.e., not a main category and one of its subcategories) of “information” and “emotion” were compared within the Facebook data. The relation between these variables was significant (χ2(1) = 10.72, p = .001, N = 502). Messages were more likely to be informational than emotional in content within the Facebook data. Similarly, a chi-square test of independence was conducted with the Twitter data. Again, the two most prevalent, distinct categories within the dataset, “information” and “emotion,” were included in the analysis. The relation between these variables is significant (χ2(1) = 4.48, p = .03, N = 342). Much like Facebook, messages on Twitter were more likely to contain informational rather than emotional content.

346

-.03

-.15**

18. Tang.

19. AskInfo

St. Dev.

12.78

6.71

-.14**

.04

-.02

-.07

-.08

.08

-.03

.17**

-.10*

.09*

.00

.47

.32

.21**

.32**

-.45**

-.05

.06

.09*

-.05

.03

.18**

.02

-.14**

.12**

.20**

-.15**

-.15**

-.74**

-.14**

-.24**

1

3

.31

.11

-.06

-.08

.08

-.05

.01

.05

-.03

.03

-.01

.06

-.04

-.04

-.03

-.07

-.09*

-.37**

-.07

1

4

Note: * p < .05, ** p < .01, *** p < .001

38.19

174.15

Mean

.02

-.03

17. Inspire

.02

.03

16. Esteem

21. Action

-.02

15 Desc.

20. Fun

-.05

-.08

13 Provide

14 Solicit

-.08

12 Emotion

-.07

.14**

-.19**

10 T1Dinfo

11 Soc-Info

9 Month

.05

-.07

.09*

.13**

8 Med. Info

-.06

-.13**

.01

-.18**

6 Is Link

-.03

.18**

.03

1

2

7 Info

-.01

-.04

4 Is Status

5 Is Video

.22**

3 Is Photo

1

.44**

2 Comment

1 Shares

1

.18

.04

.15**

-.06

-.13**

-.03

.08

-.01

.26**

-.04

-.02

.01

.06

.12**

.10*

.00

.05

-.21**

1

5

.45

.73

-.22**

-.23**

.43**

.09

-.089*

-.12**

-.03

-.03

-.17**

-.07

.13**

-.13**

-.22**

.19**

.17**

1

6

Table 1. Correlation table for Facebook data

.30

.10

.09*

-.34**

.07

-.09*

-.03

-.13**

.05

.18**

.11*

.15**

.59**

.18**

.15**

.21**

1

7

.27

.08

-.02

-.10*

-.18**

.09

-.06

-.09

-.03

-.16**

-.01

-.18**

-.21**

-.06

-.08

1

8

.29

.09

.22**

-.06

-.18**

.01

-.01

-.04

-.02

-.09*

.15**

.00

-.08

.14**

1

9

.49

.58

.00

-.07

-.21**

-.05

-.02

-.05

.07

-.12**

-.05

-.12**

-.18**

1

10

.46

.30

.03

-.09

.26**

-.09*

.00

-.06

.07

.29**

.10*

.24**

1

11

.28

.09

.14**

-.11*

-.22**

-.01

.26**

.28**

.12**

.71**

.44**

1

12

.34

.13

.42**

-.09*

-.19**

.05

.10*

.04

-.02

.21**

1

13

.25

.06

.11*

-.07

-.10*

-.01

-.09*

-.04

-.04

1

14

.08

.01

-.03

-.02

-.05

-.01

-.02

-.02

1

15

.24

.06

-.09

-.04

-.15**

-.04

.14**

1

16

.18

.03

.04

-.01

-.13**

-.03

1

17

.15

.02

.09

-.04

-.07

1

18

.46

.31

-.26**

-.19**

1

19

.27

.08

-.10*

1

20

.36

.16

1

21

 Analyzing Online Social Support Within the Type 1 Diabetes Community

347

348

.05

10. Emotion

.17**

3.46

-.05

.08

-.02

1.53

5.07

17. Ask-Info

18. Fun

19. Action

Mean

Std. Dev.

.13

.02

-.04

-.04

-.03

-.01

.09

.10

-.02

.04

-.01

.12*

.01

-.07

-.02

-.08

-.15**

-.12*

1

3

Note: * p < .05, ** p < .01, *** p < .001

5.34

.25**

-.07

-.05

-.08

.08

-.02

16. Tangible

-.09

-.07

-.06

-.03

-.16**

-.28**

.20**

.00

.03

-.11

.52**

-.08

1

2

15. Inspire

.08

.08

-.02

-.04

8. T1D Facts

9. SocialInfo

13. Describe

.00

14. Esteem

-.07

6. Med. Info

7. Month

-.02

-.02

4. IsRetweet

5. Info

-.03

-.26**

3. IsReply

11. Provide

.00

2. Retweets

12. Solicit

1

.19**

1. Favorites

1

.50

.43

.09

.16**

-.04

-.07

-.11*

-.07

-.11

-.01

.01

-.14*

-.16**

.31**

.02

.07

.07

1

4

Table 2. Correlation table for Twitter data

.24

.94

-.06

-.06

-.11*

-.14**

-.27**

-.08

.03

.08

-.14**

-.11*

.32**

.13*

.03

.16**

1

5

.44

.27

-.17**

-.18**

.01

-.05

-.09

-.08

-.07

-.18**

-.05

-.24**

-.14*

-.22**

-.01

1

6

.11

.01

.07

-.03

-.03

-.01

-.02

-.02

-.01

-.03

-.01

-.05

-.14*

.08

1

7

.41

.21

.23**

-.15**

.01

-.04

-.10

-.10

-.06

-.15**

-.04

-.23**

-.31**

1

8

.49

.61

-.20**

.17**

.10

-.10

-.03

.09

.10

.23**

-.02

.23**

1

9

.37

.17

-.13*

-.13*

-.07

-.03

.44**

.43**

.27**

.66**

.17**

1.

10

.08

.01

-.02

-.02

-.02

-.01

-.02

.19**

-.01

-.02

1

11

.27

.08

-.08

-.09

-.07

-.02

-.06

.00

-.04

1

12

.12

.01

-.04

-.04

-.03

-.01

-.02

-.02

1

13

.18

.04

-.06

-.06

.03

-.02

-.04

1

14

.19

.04

-.06

-.06

-.05

-.02

1

15

.08

.01

-.02

-.02

-.02

1

16

.22

.05

-.07

-.07

1

17

.27

.08

-.08

1

18

.27

.08

1

19

 Analyzing Online Social Support Within the Type 1 Diabetes Community

 Analyzing Online Social Support Within the Type 1 Diabetes Community

Research Question 3 To address RQ3, which asks about the types of messages that users engage with on social media surrounding T1D, a series of independent sample t-tests was conducted. Specifically, in the first, Facebook reactions (i.e., comments on the post, shares of the post, and emoji reactions that include: love, haha, wow, sad, and angry) were compared with information. There were only significant differences for two of these reactions: love (emoji), and haha (emoji). For the first, there were more “love” emoji reactions to posts that were coded as informational (M = 3.01, SD = 11.07), t(500) = 2.67, p = .008. Second, the response of a “haha” emoji was also higher on posts that were coded as informational (M = 0.16, SD = 1.82), t(500) = 3.51, p = .001. To summarize, these results suggest that informational posts receive more reactions that involve the emoji responses of love and haha. Specifically, the present study’s results indicate that when Facebook posts include informational-based content, members respond by showing a positive response. Next, an independent sample t-test was conducted to compare Facebook reactions relating to emotion. There were significant differences in shares and the following emoji reactions: haha and sad. First, the posts that contained emotional content had a higher average number of shares than other posts (M = 18.07, SD = 70.87), t(488.44) = 2.34, p = .02. Second, posts with emotional content had a higher level of the “haha” emoji responses (M = 0.10, SD = 0.68), t(360.49) = 3.53, p < .001 than other posts. Finally, messages that included emotional content had a lower average of the “sad” emoji responses (M = 8.46, SD = 28.28), t(160.09) = -2.67, p = .008 than other messages. These results suggest that emotional posts receive reactions that involve higher levels of sharing and “haha” emoji responses. Surprisingly, in contrast, emotional posts receive a lower level of “sad” emoji responses. Due to the relatively low level of both types of solicitation (i.e., direct and indirect), a new variable was created by combining the solicitation and implicit categories to capture all requests for emotional support. Next, an independent sample t-test was conducted to compare reactions for the independent variable “Asking” in the Facebook data. There were significant differences in comments and shares. First, the average number of comments was higher in posts that requested emotional support (M = 11.47, SD = 19.21), compared to other posts t(108.64) = -2.90, p = .005. Likewise, there were more shares in the posts requesting emotional support (M = 11.00, SD = 57.01), t(478.12) = 3.03, p = .003 than other posts. These results suggest that individuals who ask for emotional support may receive responses through comments and shares. Specifically, the present study’s results indicate that individuals seeking emotional support likely receive some level of this support through these reactions on Facebook. To address RQ3 within the Twitter data, an independent sample t-test was conducted to compare the retweet count in both the information and emotion variables. There was no significant difference in the information category. However, there was a significant difference in the emotion category. Specifically, messages that contained emotional content had higher retweet counts (M = 1.60, SD = 2.29) than other messages (t(214.92) = 4.94, p < .001). Indeed, the results suggest that emotion has an effect on whether a message is retweeted. In other words, as suggested by prior research (e.g., Berger & Milkman, 2012), emotional content is related with sharing messages. Finally, in order to address both the third and fourth research questions, four hierarchical regression models were tested. Specifically, to more fully examine which type of messages engage individuals on Twitter and Facebook, two hierarchical linear regression models were conducted for each platform. User engagement was operationalized as steps users take to further interact with one another and/or the message. There were two ways in which engagement was measured for each context, for a total of four 349

 Analyzing Online Social Support Within the Type 1 Diabetes Community

engagement measures: (1) Facebook posts’ “shares” counts; (2) Facebook posts’ comments counts; (3) Twitter messages’ “retweet” counts; and (4) Twitter messages’ “favorite” counts. Message engagement on Facebook was also examined with hierarchical linear regression. The first model, with shares as the dependent variable, is statistically significant (F = 3.54(18, 483), p < .001) and explains 12% of the variance (R2 = 0.12). Messages coded as providing informational support are significantly related to retweets (β = 63.25, p < .05) after controlling for message type. Likewise, the model with comments as the dependent variable was also statistically significant (F = 3.74(18, 483), p < .001) and explains 13% of the variance (R2 = 0.13). Information about medication and treatment is significantly related to the number of comments on Facebook posts (β = 7.14, p < .001), as is solicitation of emotional support (β = 6.30, p < .05). Interestingly, posts that provide emotional support (β = -5.85, p < .05) and that serve as a call to action (β = -4.13, p < .05) are negatively related to the number of comments. The hierarchical linear regression model that examined the relationship between the message content and Twitter “retweets” was statistically significant (F = 10.76(18,323), p < .001) and explained more than 30% of the variance (R2 = 0.34). Interestingly, of the coded content, only social information (β = -2.03, p < .001), fun (β = 4.39, p < .001), and call to action (β = 2.17, p < .05) are statistically significantly associated with retweets after controlling for the message type (Table 3). To examine the final engagement context, a hierarchical linear regression was conducted with favorite counts as the dependent variable. This model was also statistically significant (F = 2.16(18,323), p < .001), but explained less variance (R2 = 0.11). Within this model, the messages that were coded as “fun” are statistically significant (β = 2.42, p < .05). As shown in Table 3, the other messages types are not statistically significant.

Research Question 4 The standardized regression coefficients from the Facebook (Table 3) and Twitter (Table 4) posts were examined to address RQ4, which asked if there is a difference in platform usage. This decision was made because the standardized coefficients are in standard deviation units, making them comparable across datasets (e.g., Glass & Hopkins, 1996). On Facebook, the largest significant relationship is seen between with comments on posts containing treatment and medication information (Standardized Beta = 0.17, p < .001). However, among tweets, the largest significant relationship is seen between posts coded as fun and retweets (Standardized Beta = 0.22, p < .001). Thus, it appears as though individuals may use these platforms for different purposes. Specifically, based on the present study’s results, Facebook may be used for providing more specialized content. In contrast, Twitter may be used to share information that is less specific to the T1D community. These findings are supported by prior research examining the utilities of these platforms (e.g., Correa et al., 2010).

FUTURE RESEARCH DIRECTIONS There are a number of contributions stemming from this chapter. As evidenced earlier, much work has been done in understanding the role of friends, family, and community members in providing social support for individuals (e.g., Gallant, 2003; Heinze et al., 2015). This is important as prior research has suggested that disease-specific support may be important for patient health outcomes (e.g., Aalto et al., 1997). Moreover, as indicated by the findings presented above, there are discrepancies between the types of support enacted by T1D patients in an online setting. Further, as can be expected, the uses of social 350

 Analyzing Online Social Support Within the Type 1 Diabetes Community

Table 3. Regression coefficients for Facebook data Shares Counts β

SE

Std. Beta

Block 1 Constant

.00

170.56

Is Photo

92.39

171.08

Is Status

32.72

172.16

Is Video

.53

Is Link

Comments Counts R2

F

0.05

6.33(4,497)

β

SE

Std. Beta

.00

12.59

.25

7.32

12.63

.27

.06

13.30

12.71

.32

174.99

.00

4.68

12.91

.07

8.91

170.88

.03

5.19

12.61

.20

Information

63.25*

28.93

.16*

-2.86

2.11

-.10

Med. Info

32.69

32.82

.06

7.14***

2.39

.17***

Month

31.82

31.51

.05

-.05

2.29

.00

Block 2

0.12

3.54(18,483)

T1D Facts

23.33

31.35

.04

-.78

2.28

-.02

Social Info

-75.60

25.04

-.21

1.72

1.82

.07

Emotional

14.61

35.21

.04

1.10

2.56

.04

Provision

-61.23

34.56

-.10

-5.85*

2.51

-.13*

Solicitation

-19.43

34.26

-.05

6.30*

2.49

.20*

Description

-4.02

106.27

.00

-4.39

7.73

-.03

Esteem

16.12

37.53

.02

3.30

2.73

.06

Inspirational

-41.59

48.80

-.04

-4.38

3.55

-.06

Info-Requests

3.85

22.31

.01

.98

1.62

.04

Fun

-5.74

32.95

-.01

-.17

2.40

.00

Call to Action

1.46

24.52

.00

-4.13*

1.78

-.12

R2

F

0.04

4.90(4,497)

0.13

3.74(18,483)

Note: * p < .05, ** p < .01, *** p < .001

media platforms differs. Specifically, Facebook posts may be more analogous to a group discussion, whereas Twitter posts are more typical of a town-crier that has thrown out messages for the masses. Understanding the instances in which social media may be the most helpful could help form interventions or information that could be shared with patients suffering a chronic illness. Moving forward, communication scholars may also examine the uses of other specialized social media sites or apps in relation to T1D management. Although some work has suggested that individuals use Snapchat to share trivial information with their close ties (e.g., Bayer, Ellison, Schoenebeck & Falk, 2016), this type of light-hearted interaction may still prove beneficial for individuals dealing with a taxing condition such as T1D. Moreover, social support may also play a role in individuals’ risk for developing chronic conditions. For instance, in a review of the 2010 Danish Health and Morbidity Survey, Hempler, Ekholm, and Willaing (2013) found that people with T2D were more likely to live without a partner, see their family less than once per month, and feel less certain of being able to count on help from other people if they were ill compared to the general population. Implications from this study include the need to build additional types of social networks for patients with T2D (Hempler et al., 2013).

351

 Analyzing Online Social Support Within the Type 1 Diabetes Community

Table 4. Regression coefficients for Twitter data Retweet Counts β

SE

Constant

1.09***

.33

Is Reply

-.75

1.90

5.56***

Std. Beta

β

SE

2.72***

.36

-.02

-1.05

2.03

-.03

.50

.52***

-2.72***

.54

-.27***

-2.27

1.22

-.10

-0.16

1.38

-.01

.65

.65

.05

-0.01

.74

.00

-1.92

2.21

-.04

0.30

2.51

.01

Block 1

Is Retweet

Med. Info Diabetes Month

R

.27

Block 2 Information

Favorite Counts 2

.34

F

Std. Beta

62.46(2,339)

10.76(18,323)

T1D Facts

.55

.74

.04

1.05

.84

.09

Social Info

-2.03***

.62

-.19***

0.44

.70

.04

Emotional

1.11

3.88

.08

2.24

4.40

.17

Provision

-3.10

3.87

-.04

-3.33

4.39

-.05

Soliciting

-.46

3.82

-.02

-2.61

4.34

-.14

Description

-.58

4.32

-.01

-4.08

4.90

-.10

Esteem

-1.64

3.60

-.06

0.28

4.09

.01

Inspire

-2.10

4.08

-.08

-0.61

4.64

-.02

Tangible

-3.03

3.14

-.04

-1.79

3.57

-.03

Request Info

-.65

1.13

-.03

-1.54

1.28

-.07

4.39***

.99

.22***

2.42*

1.13

.13*

2.17*

.95

.11*

0.06

1.08

.00

Fun Call to Action

R2

F

.07

12.72(2,339)

.11

2.16(18,323)

Note: * p < .05, ** p < .01, *** p < .001

Building upon these findings, future research may explore ways in which patients with other chronic illnesses, such as T1D, benefit from social support that is enacted through social media and other computer-mediated sources. In other words, future research may benefit from examining ways in which other online communities may help mitigate negative effects of less desirable social support in personal networks. Importantly, the present chapter’s contributions may help in guiding recommendations regarding platforms on which individuals may have the best chance of finding support to suit their needs. For instance, if individuals are looking for informational social support, both Facebook and Twitter may serve the purpose well. However, going a step further, the information messages on Facebook were more specifically focused on T1D. In other words, although both Facebook and Twitter messages provided informational support, the data suggest a stronger T1D community presence on Facebook. One reason for this finding is likely due to the centralized nature of the posts. Specifically, the data collected from Facebook originated from a public page that focuses on information and support for people affected by T1D. In contrast, the data collected from Twitter contained the “T1D” hashtag, which marked the message as being part of the T1D conversation. However, this tag does not ensure a central location for all messages. Moreover, using a tag on Twitter does not come with the same level of monitoring as is seen on

352

 Analyzing Online Social Support Within the Type 1 Diabetes Community

a Facebook page. The effect of this is illustrated with the data. Specifically, within the Facebook posts, the technical category of codes captured a message from a page administrator who wanted to remind the users of the guidelines for posting on the page. Conversely, the data collected from Twitter contained a high proportion of spam messages that did not contribute to the T1D conversation. Along with the inclusion of spam, a portion of the messages posted on Twitter contained critical or judgmental material that would have been flagged by an administrator. Thus, based on these findings, individuals who are seeking consistent, constructive informational support for dealing with a chronic illness such as T1D may be best served by an online community—such as what may be found within a structured Facebook page or group. If information is desired, Twitter may be useful although users may want to be mindful of its sourcing. Despite a number of peer-reviewed, scientific articles being represented through tweets’ links, there were also a number of articles and resources that lacked the same scientific rigor and credibility. Thus, caution should be utilized regarding information that is shared through social media platforms such as Twitter. Moving forward, additional research is needed to address differences in perceived and received social support. In other words, the importance of understanding whether individuals with T1D perceive having social support available through social media is needed. One reason why the present study saw more informational posts than emotionally supportive posts could have been due to the nature of the setting. Specifically, perhaps individuals use other platforms or messaging applications—such as Instagram or Snapchat—to give and receive emotional support with close ties whereas the public Facebook page and hashtag on Twitter may be a way of receiving more diabetes-specific support from looser ties. However, as seen in prior research, the perception of having access to the desired type of social support is important for health outcomes (e.g., Gallant, 2003). Thus, further work is needed to understand whether individuals who are affected by T1D feel as though they are able to receive the types of social support they need through social media platforms. This is an area in which scholars and practitioners’ work could converge to provide resources necessary for handling a chronic illness such as T1D. Additionally, the literature would benefit from further examinations of specific types of posts and the types of support they elicit. Specifically, within the present study, photo-based posts were significantly correlated with sharing (r = 0.22, p < .01), but not with commenting. Prior work suggests that photo-based posts on social media may be related to users’ needs within a social network (e.g., Oeldorf-Hirsch & Sundar, 2016).

CONCLUSION To summarize, this chapter adds to the literature by examining the way in which individuals affected by T1D give and receive social support on social media platforms. Its findings suggest that informational support is prevalent on both Facebook and Twitter. However, the uses of these platforms appear to differ. Specifically, on Facebook, there is a significant relationship between the number of comments and messages that contain information about treatment and medication information. Conversely, on Twitter, a significant relationship is seen between retweets and content that contains “fun” content. Thus, the two-sample study allows a comparison to be made between types of support enacted on Facebook as well as Twitter. Despite this contribution, there are some limitations that must be addressed. First, the content was analyzed by two trained coders. Despite the coders’ expertise with the topic of social support, human error is always a possibility. In order to address this limitation, the researchers decided to have coders 353

 Analyzing Online Social Support Within the Type 1 Diabetes Community

discuss discrepancies in order to meet 100% agreement on all posts. Second, the amount of spam and other messages that were excluded from the Twitter data reduced the sample size. Although a large sample of tweets was drawn for this study in anticipation of this issue, this still presented a challenge. In further analyzing the data, it was found that nearly all of the spam messages originated from one user that appears to auto-generate tweets very frequently throughout the day, with many messages being repeated throughout the cycle. Third, the analysis included posts from one public Facebook page and one hashtag that is used widely on Twitter. Although both of these data sources are popular on their respective platforms, the researchers cannot guarantee that they are representative of the population of T1D Facebook pages and tweets. Thus, future research should include multiple sources of data from each platform. Despite these limitations, there are a number of positive contributions stemming from the present research. Specifically, the inclusion of a mixed methods approach allowed a thorough analysis of the data to be undertaken. In other words, this chapter discusses the findings of a study in which the content of messages was qualitatively analyzed. This allowed a deeper understanding of the types of social support messages that are seen on social media platforms. Moreover, the quantitative analysis allows the results to be placed within a larger discussion. That is, this study’s findings suggest that informational support is more prevalent than other types of support (or message content) on both Facebook and Twitter. This is important for scholars and practitioners as they develop future interventions and campaigns to reach individuals who are affected by T1D. In addition, the chapter’s discussion of the types of content that receives user engagement suggests that information—both of the practical type (on Facebook) and for providing a lighthearted reprieve from T1D (on Twitter) is related to comments and sharing, respectively. Thus, on a conceptual level, both of these actions demonstrate individuals’ interest in the topic. In other words, information and lighthearted content may be particularly valued by individuals with T1D on these platforms. Finally, on a theoretical level, the present study contributes to our knowledge of social support as it is enacted within online settings. Specifically, perhaps rather than focusing on informational support in its official format, scholars will refine its conceptualization to include informal anecdotes and personal narratives. This overlap between information exchange and emotional solicitation may become a beneficial aspect of online social support for individuals who are dealing with a chronic illness. In other words, the specificity and shared experience of this type of community—as seen with the present study’s “social information” messages—may provide both helpful information as well as a sense of belonging. Thus, an overlap between information and emotion may be facilitated through social media.

REFERENCES Aalto, A. M., Uutela, A., & Aro, A. R. (1997). Health related quality of life among insulin-dependent diabetics: Disease-related and psychosocial correlates. Patient Education and Counseling, 30(3), 215–225. doi:10.1016/S0738-3991(96)00963-9 PMID:9104378 Bayer, J. B., Ellison, N. B., Schoenebeck, S. Y., & Falk, E. B. (2016). Sharing the small moments: Ephermeral social interaction on Snapchat. Information Communication and Society, 19(17), 956–977. do i:10.1080/1369118X.2015.1084349 Berger, J., & Milkman, K. L. (2012). What makes online content viral? JMR, Journal of Marketing Research, 49(2), 192–205. doi:10.1509/jmr.10.0353

354

 Analyzing Online Social Support Within the Type 1 Diabetes Community

Chang, R., Pimentel, S., & Svistunov, A. (2011). Sentiment analysis of occupy wall street tweets. In CS 229. Machine Learning Final Projects. Chen, W., & Choi, A. S. K. (2011). Internet and social support among Chinese migrants in Singapore. New Media & Society, 13(7), 1067–1084. doi:10.1177/1461444810396311 Ciot, M., Sonderegger, M., & Ruths, D. (2013, October). Gender inference of Twitter users in nonEnglish contexts. EMNLP. Correa, T., Hinsley, A. W., & De Zúñiga, H. G. (2010). Who interacts on the Web?: The intersection of users’ personality and social media use. Computers in Human Behavior, 26(2), 247–253. doi:10.1016/j. chb.2009.09.003 du Pré, A. (2005). Communicating about health: Current issues and perspectives (2nd ed.). New York: Oxford University Press. Fukunishi, I., Horikawa, N., Yamazaki, T., Shirasaka, K., Kanno, K., & Akimoto, M. (1998). Perception and utilization of social support in diabetic control. Diabetes Research and Clinical Practice, 41(3), 207–211. doi:10.1016/S0168-8227(98)00083-7 PMID:9829351 Gallant, M. P. (2003). The influence of social support on chronic illness self-management: A review and directions for research. Health Education & Behavior, 30(2), 170–195. doi:10.1177/1090198102251030 PMID:12693522 Glass, G. V., & Hopkins, K. D. (1996). Statistical Methods in Education and Psychology (3rd ed.). Needham Heights, MA: Pearson. Global Diabetes Community. (2016). Guide to HbA1c. Retrieved March 15, 2016, from http://www. diabetes.co.uk/what-is-hba1c.html Greene, J. A., Choudhry, N. K., Kilabuk, E., & Shrank, W. H. (2010). Online social networking by patients with diabetes: A qualitative evaluation of communication with Facebook. Journal of General Internal Medicine, 26(3), 287–292. doi:10.100711606-010-1526-3 PMID:20945113 Heinze, J. E., Kruger, D. J., Reischl, T. M., Cupal, S., & Zimmerman, M. A. (2015). Relationships among disease, social support, and perceived health: A lifespan approach. American Journal of Community Psychology, 56(3-4), 268–279. doi:10.100710464-015-9758-3 PMID:26462808 Hempler, N. F., Ekholm, O., & Willaing, I. (2013). Differences in social relations between persons with type 2 diabetes and the general population. Scandinavian Journal of Public Health, 41(4), 340–343. PMID:23554389 Henry, S. L., Rook, K. S., Stephens, M. A., & Franks, M. M. (2013). Spousal undermining of older diabetic patients’ disease management. Journal of Health Psychology, 18(12), 1550–1561. doi:10.1177/1359105312465913 PMID:23325381 Himelboim, I., & Han, J. Y. (2014). Cancer talk on Twitter: Community structure and information sources in breast and prostate cancer social networks. Journal of Health Communication, 19(2), 210–225. doi: 10.1080/10810730.2013.811321 PMID:24111482

355

 Analyzing Online Social Support Within the Type 1 Diabetes Community

House, J. S. (1981). Work Stress and Social Support. Addison-Wesley Publishing Co. House, J. S., & Kahn, R. L. (1985). Measures and concepts of social support. In S. Cohen & L. Syme (Eds.), Social Support and Health (pp. 83–108). Orlando, FL: Academic Press. Hu, Y. (2015). Health communication research in the digital age: A systematic review. Journal of Communication in Healthcare, 8(4), 260–288. doi:10.1080/17538068.2015.1107308 Hughes, D. J., Rowe, M., Batey, M., & Lee, A. (2012). A tale of two sites: Twitter vs. Facebook and the personality predictors of social media usage. Computers in Human Behavior, 28(2), 561–569. doi:10.1016/j.chb.2011.11.001 Huh, J., Liu, L. S., Neogi, T., Inkpen, K., & Pratt, W. (2014). Health vlogs as social support for chronic illness management. ACM Transactions on Computer-Human Interaction, 21(4), 1–31. doi:10.1145/2630067 PMID:26146474 Klemm, P., Bunnell, D., Cullen, M., Soneji, R., Gibbons, P., & Holecek, A. (2003). Online cancer support groups: A review of the research literature. CIN: Computers, Informatics. Nursing, 21(3), 136–142. PMID:12792194 Klemm, P., & Wheeler, E. (2005). Cancer caregivers online: Hope, emotional roller coaster, and physical/ emotional/psychological responses. CIN: Computers, Informatics. Nursing, 23(1), 38–45. PMID:15622203 Kyngäs, H., Hentinen, M., & Barlow, J. H. (1998). Adolescents’ perceptions of physicians, nurses, parents and friends: Help or hindrance in compliance with diabetes self‐care? Journal of Advanced Nursing, 27(4), 760–769. doi:10.1046/j.1365-2648.1998.00608.x PMID:9578206 Myrick, J. G., Holton, A. E., Himelboim, I., & Love, B. (2016). # Stupidcancer: Exploring a typology of social support and the role of emotional expression in a social media community. Health Communication, 31(5), 596–605. doi:10.1080/10410236.2014.981664 PMID:26453480 Oeldorf-Hirsch, A., & Sundar, S. S. (2016). Social and technological motivations for online photo sharing. Journal of Broadcasting & Electronic Media, 60(4), 624–642. doi:10.1080/08838151.2016.1234478 Oh, H. J., & Lee, B. (2012). The effect of computer-mediated social support in online communities on patient empowerment and doctor–patient communication. Health Communication, 27(1), 30–41. doi:1 0.1080/10410236.2011.567449 PMID:21797714 Piette, J. D., Resnicow, K., Choi, H., & Heisler, M. (2013). A diabetes peer support intervention that improved glycemic control: Mediators and moderators of intervention effectiveness. Chronic Illness, 9(4), 258–267. doi:10.1177/1742395313476522 PMID:23585636 Reblin, M., & Uchino, B. N. (2008). Social and emotional support and its implication for health. Current Opinion in Psychiatry, 21(2), 201–205. doi:10.1097/YCO.0b013e3282f3ad89 PMID:18332671 Robinson, J. D., Turner, J. W., Levine, B., & Tian, Y. (2011). Expanding the walls of the health care encounter: Support and outcomes for patients online. Health Communication, 26(2), 125–134. doi:10. 1080/10410236.2010.541990 PMID:21294020

356

 Analyzing Online Social Support Within the Type 1 Diabetes Community

Roblin, D. W. (2011). The potential of cellular technology to mediate social networks for support of chronic disease self-management. Journal of Health Communication, 16(sup1), 59-76. Rosland, A. M., Heisler, M., & Piette, J. D. (2012). The impact of family behaviors and communication patterns on chronic illness outcomes: A systematic review. Journal of Behavioral Medicine, 35(2), 221–239. doi:10.100710865-011-9354-4 PMID:21691845 Ross, C., Orr, E. S., Sisic, M., Arseneault, J. M., Simmering, M. G., & Orr, R. R. (2009). Personality and motivations associated with Facebook use. Computers in Human Behavior, 25(2), 578–586. doi:10.1016/j.chb.2008.12.024 Sarasohn-Kahn, J. (2008). The wisdom of patients: Healthcare meets online social media ihealth reports. Accessed December 16, 2016 from http://www.chcf.org/topics/chronicdisease/index.cfm?itemID=133631 Shapiro, J. (2009). Patients turn to online community for help healing. National Public Radio. Strine, T. W., Chapman, D. P., Balluz, L., & Mokdad, A. H. (2008). Health-related quality of life and health behaviors by social and emotional support. Social Psychiatry and Psychiatric Epidemiology, 43(2), 151–159. doi:10.100700127-007-0277-x PMID:17962895 Taylor, S. E., Klein, L. C., Gruenewald, T. L., Gurung, R. A. R., & Fernandes-Taylor, S. (2003). Affiliation, social support, and biobehavioral responses to stress. In J. Suls & K. A. Wallston (Eds.), Social Psychological Foundations of Health and Illness (pp. 314–331). doi:10.1002/9780470753552.ch12 Uchino, B. N., Cacioppo, J. T., & Kiecolt-Glaser, J. K. (1996). The relationship between social support and physiological processes: A review with emphasis on underlying mechanisms and implications for health. Psychological Bulletin, 119(3), 488–531. doi:10.1037/0033-2909.119.3.488 PMID:8668748 van Dam, H. A., van der Horst, F. G., Knoops, L., Ryckman, R. M., Crebolder, H. F., & van den Borne, B. H. (2005). Social support in diabetes: A systematic review of controlled intervention studies. Patient Education and Counseling, 59(1), 1–12. doi:10.1016/j.pec.2004.11.001 PMID:16198213 Wallston, B. S., Alagna, S. W., DeVellis, B. M., & DeVellis, R. F. (1983). Social support and physical health. Health Psychology, 2(4), 367–391. doi:10.1037/0278-6133.2.4.367 Yardi, S., Romero, D., Schoenebeck, G., & Boyd, D. (2009). Detecting spam in a twitter network. First Monday, 15(1). doi:10.5210/fm.v15i1.2793

KEY TERMS AND DEFINITIONS Caregivers: Individuals who provide care for another person, especially those who are chronically ill. Chronic Illness: An illness or disease that continually affects an individual; this must be dealt with all the time, rather than an acute illness that will resolve over time. Emoji Reactions: This image-based reaction allows user on Facebook to select an icon to reflect their reaction to a message. Options include reactions such as: love, haha, wow, sad, and angry. Emotional Support: A form of social support that centers on emotional factors such as acceptance and helping the recipient feel as though he or she is not alone.

357

 Analyzing Online Social Support Within the Type 1 Diabetes Community

Facebook: A social media platform that allows individuals to follow organizations’ pages, join groups focused on similarities, and connect with friends, who are either known in person or solely online. Informational Support: A form of social support that focuses on providing information relating to a specific topic. Retweet: A message that did not originate from the person who posted it on Twitter (i.e., this is a form of sharing a message). Social Support: An individual receiving help of some sort—such as caring, information, or tangible resources—from others, whether it is perceived or actually enacted. Tweet: A short message (containing 140 characters or fewer) posted by a Twitter user that contains content such as text, photos, or a link to another source. Twitter: A social media platform that allows individuals to send short messages (i.e., “tweets”) that contain 140 characters or fewer. Type 1 Diabetes (T1D): A chronic autoimmune illness that affects individuals’ metabolic functioning.

This research was previously published in Global Perspectives on Health Communication in the Age of Social Media edited by Seif Sekalala and Brandon C. Niezgoda, pages 59-84, copyright year 2018 by Medical Information Science Reference (an imprint of IGI Global).

358

359

Chapter 18

Diabetes Mellitus and Aging Jyoti Mishra Pandey Government Medical College Chandigarh, India Preeti Mishra SMI Medical College and Hospital, India

ABSTRACT Aging mirrors all the changes that occur over the period of life. It comes with various changes both positive and negative. Among all medical illnesses, Diabetes Mellitus is one of the most common and serious medical condition that has affected not only the aging population but also the young children and adults as well. Diabetes and its complications can contribute to aging process in a number of ways and the complications can speed up the aging process as well. For people with type 2 diabetes managing their emotional health can be as important as keeping their blood sugar under control. Patients with diabetes mellitus need psychological support throughout their life span from the time of diagnosis. However, provision of psychosocial support is generally inadequate due to its challenging nature of needs and demands on the healthcare systems. The present chapter will cover different aspects of diabetes mellitus and its impact on human life and also how with healthy coping mechanism one can prevent the distressing effect of diabetes on aging and vice versa.

INTRODUCTION Health is a crown that the healthy wears, but only the sick can see it (Imam Shafiee) Diabetes is a major health concern in both developing and developed countries. A person with diabetes under goes significant emotional and psychological turmoil like distress, anxiety and depression. This illness which is chronic in nature requires a constant effort for healthy life management. Among all medical illnesses, Diabetes Mellitus is one of the most common and serious medical condition that has affected not only the aging population but also the young children and adults as well. For people with diabetes managing their emotional health can be as important as keeping their blood sugar under control. Patients with diabetes mellitus need psychological support throughout their life span beginning from the time of diagnosis. The psychological make-up of the patients with diabetes mellitus plays a DOI: 10.4018/978-1-5225-7122-3.ch018

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Diabetes Mellitus and Aging

central role in self-management behaviors. Without patient’s adherence to the effective therapies, there would be persistent sub-optimal control of the disease, increased diabetes-related complications, causing deterioration in quality of life, resulting in increased healthcare utilization and burden on healthcare systems. So, preventing the disastrous effect of diabetes especially in elderly becomes important as they are more prone to various bio-psychosocial changes and its consequences. India had more than 91.6 million elderly in 2010 with an annual addition of 2.5 million elderly between 2005 and 2010. The number of elderly in India is projected to reach 158.7 million in 2025 (United Nations Department of Economic and Social Affairs, 2008), and is expected, by 2050, to surpass the population of children below 14 years (Raju, 2006). Genetic loading, unhealthy life styles and obesity remain significant contributors towards developing diabetes. The disease burden is huge as exemplified by the World Health Organization report of 2016 which states that diabetes caused 1.5 million deaths in 1 year. Higher-than-optimal blood glucose caused an additional 2.2 million deaths, by increasing the risks of cardiovascular and other diseases. Forty-three percent of these 3.7 million deaths occur before the age of 70 years. The percentage of deaths attributable to high blood glucose or diabetes that occurs prior to age 70 is higher in low- and middle-income countries than in high-income countries (WHO, 2016). The global prevalence of type 2 diabetes mellitus is rapidly growing as a consequence of life-style changes, urbanization and population aging (Chen et al., 2011). The American Diabetes Association (ADA, 2014) has classified diabetes into four categories: Type 1 diabetes mellitus, caused by autoimmune destruction of the pancreatic beta cells; type 2 diabetes mellitus, itself a highly diverse group of disorders involving insulin resistance combined with relative insulin deficiency; gestational diabetes mellitus; and other specific types, another heterogeneous group which includes, among others, forms of diabetes resulting from the inheritance of a mutation in a single gene (monogenic diabetes). The majority of people with diabetes are affected by type 2 diabetes. It is a chronic illness that occurs either when the pancreas does not produce enough insulin or when the body cannot efficiently use the insulin it produces. Children normally suffer from type 1 diabetes whereas adult and elderly often suffers from type 2 diabetes. The ground of type 1 diabetes is unknown and is currently not preventable. The symptomatology of type 1 DM includes excessive urination, thirst, constant hunger, weight loss, fatigability and vision changes. The sign and symptoms of type 2 diabetes may be similar to those of type 1 diabetes, but are often less manifested or even absent. Therefore, the disease may go undiagnosed for several years, until complications have already takes place. Diabetes mellitus is among those hazardous factors that affects the aging person. Since aging itself brings various physical and psychological changes in the person, diabetes mellitus becomes an additional factor to their overall physical and psychological changes. Aging as a whole causes changes throughout the entire body; basal metabolic rate, the amount of energy required declines with age. As they age and more the time passes, their body slowly becomes less adaptive at using glucose from the bloodstream, their visual acuity declines and so as the hearing ability. Other cognitive abilities and higher executive functioning, such as spatial ability, complex problem solving, and working memory, reasoning, planning all tend to decline to some extent with age. Diabetes and aging are often associated with various psychological and emotional states. This is a condition where people know that there is no looking- back followed by various emotional symptoms like; • • • 360

Difficulty in accepting the diagnosis Don’t want to discuss Decrease self-care

 Diabetes Mellitus and Aging

• • • • • • • •

Sleep disturbances Weight loss Difficulty in concentration Fatigability Thought of diabetes is overpowering Losing interest in pleasurable activities Withdrawal from near and dear ones Suicidal ideation and self-destructive behavior

AGING AND DIABETES There are multiple factors that contribute to aging. Aging in-turn itself contributes to various illnesses and to its complications. Diabetes’ input to the aging process occurs in a number of ways; cardiovascular disease can age nearly any tissue in the body by diminishing its blood supply, eye disease related to diabetes, including retinopathy, macular edema, and cataracts, can worsen already fading eyesight, diabetes related nerve disease can complicate the arthritis that comes with age, sometimes allowing greater joint erosion in the foot, and kidney disease can speed the decline in kidney function often seen with age. Hypoglycemia (low blood glucose) is one of the important concerns in elderly with diabetes. This population is prone to low blood glucose level because of the multiple drugs intake which may cause hypoglycemia, impaired glucose counter regulation, greater risk for an age-related decline in liver and kidney function, poor appetites and infrequent meals, all these factors may predispose to the elderly diabetics in developing hypoglycemia. It is one of those conditions that also speed up the aging process. On the other side, aging can make diabetes more difficult to control. One factor for this could be that insulin resistance increases and glucose tolerance decreases with age. With age, a person finds it difficult to focus attention and also faces difficulty in sustaining attention. As a result, they face difficulty in paying attention to the management required in diabetes, for example; meal planning, blood glucose monitoring, carbohydrate counting and intake of insulin and its correct doses. However, in today’s scenario because of the better health approaches and services people with diabetes now have more opportunity to live longer than ever before.

CONSEQUENCES OF DIABETES ON AGING Negligence in diabetes can have lethal consequences. Acute complications are a significant contributor to death, costs and poor quality of life. Significantly low blood glucose can occur in all types of diabetes and may result in seizures or loss of consciousness. There are various consequences of diabetes that affects aging;

Medical/Physical Consequences Diabetes, a medical condition, affects various part of the body. It can damage the heart, blood vessels, eyes, kidneys and nerves. It can also increase the risk of heart attack, stroke, kidney failure, limb amputation, vision loss and nerve damage. Diabetes is one of the leading causes of kidney failure. Over361

 Diabetes Mellitus and Aging

weight, obesity and physical inactivity are estimated to cause a large percentage of the global diabetes burden (Global Burden of Disease (GBD), 2013). Studies have found an association between diabetes and cognitive decline on repeated neuropsychological tests in elderly (Gregg et al., 2000; Fontbonne et al., 2001). Additionally, diabetes doubles the overall risk of dementia. The specific association with Alzheimer’s disease may be weaker and the association with stroke mediated dementia considerably stronger (Gregg et al., 2000; Fontbonne et al., 2001; Ott et al., 1996 & Luchsinger et al., 2001). It is also seen that diabetic women became physically disabled at approximately twice the rate of non-diabetic women and have an increased risk of falls and hip fractures (Schwartz et al., 2001; Gregg et al., 2002). The medical consequences in elderly with diabetes doubles because of the influence of behavioral factors like physical inactivity, inadequate sleep and poor life style. Uncontrolled diabetes can lead to poor health status and has been associated with disability, various other conditions like micro and macrovascular complications, and can also result in premature death as well (Krag et al., 2016). The management of this elderly population will be difficult because of the several other diseases and necessitation of numerous medications, however, prevention of secondary cardiovascular disease, weight loss and screening for depressive disorder and its treatment may help prevent disability that occurs in elderly with diabetes.

Psychological Consequences Physical and medical condition of diabetes affects the mental health of the individual. Co-occurring psychiatric disorders in patients with diabetes are associated with impaired quality of life (Goldney et al., 2004), increased cost of care (Hutter et al., 2010), poor treatment adherence (Gonzalez et al., 2007), poor glycemia control (evidenced by elevated HbA1c levels) (Lustman, 2000), increased emergency room visits due to diabetic ketoacidosis, (Bryden, 2003), higher frequency of hospitalization, and higher rate of absenteeism (Das-Munshi et al., 2007).Co-morbidity of diabetes and depression correspond to a major clinical challenge as the outcomes of each condition are worsened by the presence of the other (Holt &Katon, 2012).Prevalence rates for elevated depressive symptoms range from 12–27% across studies of people with type 1 and type 2 diabetes, while rates of depressive disorders, as assessed by psychiatric interview protocols, range from 8–15% in adults with type 1 and type 2 diabetes (Anderson & Freedland, 2001; Pouweret al., 2013). Rates of diabetes-related distress have been shown to be higher (54%) than rates of psychiatrically diagnosed depression (Weissberg-Benchell & Antisdel-Lomaglio, 2011). As the elderly with diabetes and other co-morbid chronic conditions increases, outcomes such as cognitive and physical disability will become a greater distress because of their effect on their quality of life, loss of independence and demands on families or caregivers. Psychological wellbeing and health are closely related and become more essential with older people because the chance for the occurrence of chronic illness increases with advancing age. Similarly, psychological state is affected by many factors other than health such as environmental conditions, social and family relationships, social roles and activities, these factors also change with age. Psychological wellbeing may even be a protective factor in health, reducing the risk of chronic physical illness and promoting longevity. It has also been argued that psychological wellbeing should be addressed in measures of health appraisal, and be considered in health care resource allocation (Dolan & White, 2007)

362

 Diabetes Mellitus and Aging

Social Consequences There is a complex relationship between Type 2 diabetes and social determinants of health. Social factors are often related with the unequal development of chronic conditions and challenges encountered when managing medical conditions, particularly in Type 2 diabetes (Bryant et al. 2010).The major social factors affecting diabetes mellitus include; socioeconomic status (Krishnam et al., 2009), health education (Cooper et al., 2003; Brown et al., 1996), religion (Naeem, 2003), ethnicity (Bastid& Pagan, 2002), family (Grunnet, 2008), age (Kumar et al., 2008), education, locality or location (Azuamah et al., 2013). Earlier the main focus of diabetes management remained the behavioral and biologic such as diet and physical activity but now it is equally important to tackle the influence of physical and social environments, such as; poor income, unemployment or employment insecurity, low educational attainment and poor living conditions, on health outcomes. The main factor that contributes to Type II diabetes in lower status is nutrition, education and physical inactivity. The socially and economically disadvantaged are also at elevated risk for diabetes (Jacobs & Johnson 2001). It is seen that unemployment affects the physical health of the individual. It is reported that among adults aged 45 to 64 years, for example, 49% of diabetics are unemployed, compared with only 28% of non-diabetics (Krishnam et al., 2009). Religion, itself, has also a significant role to play in various physical health conditions. It has seen that more religious people had lower pressure, less hypertension, more compliance to treatment and follow-up and minimal utilization of healthcare (Naeem, 2003). Social stigma is also associated with diabetes like losing jobs, not being employed or promoted, or experiences difficulty with insurances. The qualitative studies showed that they experience unjustified unequal treatment and exclusion due to their diabetes also in other contexts of their lives (Gredig & Bartelsen-Raemy, 2016), Other experiences include travel restrictions, broken friendships and restrictions against becoming an adoptive parent (Browne et al. 2013). High quality care is crucial but faces many institutional and financial barriers, particularly for individuals in long-term care (Huskamp et al., 2011). Growing number of recognition to the social determinants of health and their contribution to health disparities accepted the need to consider the social determinants of diabetes and health along with other individual factors.

Economic Consequences Diabetes has a significant contribution in economic burden. Medical costs in diabetes comprise expenses for preventing and treating diabetes and its related complications. In a recent systematic review, it has been estimated that the direct annual cost of diabetes to the world is more than US$ 827 billion (NCD Risk Factor Collaboration, 2009; Seuring & Archangelidi, 2015). Federation (IDF) estimates that total global health-care spending on diabetes more than tripled over the period 2003 to 2013 – the result of increases in the number of people with diabetes and increases in per capita diabetes spending (International Diabetes Federation, 2013).Cost of care for non-mental health conditions among patients with co-occurring psychiatric disorders and endocrinal disorders is twofold or even higher (depending on the treatment setting) than the population without co-occurring psychiatric disorders (Centorrino et al.,

363

 Diabetes Mellitus and Aging

2009). The average medical expenses for patients with diabetes are nearly twice as high as those for patients who do not have diabetes (National diabetes statistics, 2011). These increased financial pressures put burden not only to the care takers but also have a significant impact upon the elderly. The finances involved in managing elderly with aging are not only related to medications but also to the additional support or care they require.

FACTORS AFFECTING DIABETES AND AGING There are various factors that contribute to diabetes. These are;

Personality Personality of the individual remains an essential factor to study while dealing with any medical and psychiatric illnesses. Personality factors emerge as potential vulnerability factor for adverse health outcomes. Individuals with type-2 diabetes had higher levels of depressive and anxiety symptoms. Individuals with type-2 diabetes experience more psychological distress and have different personality traits compared to individuals without type-2 diabetes (Van Dooren, 2016). A study has shown that Type D personality refers to the combination of negative affectivity, a tendency to experience negative emotions and social inhibition, a tendency to inhibit self-expression (Denoll et al., 2005). Few studies have explored the potential behavioral and biological mechanisms that may link Type D with adverse health outcomes in individuals with type 2 diabetes (Nefs et al., 2012; Conti, et al., 2016). Study showed that type D personality was more prevalent in type 2 diabetes, while personality traits like extraversion, agreeableness, consciousness and emotional stability were slightly less prevalent (Van Dooren et al., 2016). The relationship between personality traits and diabetes were mediated by body mass index (BMI), alcohol intake, physical inactivity and dietary habits or life style. Medication and other treatments improve symptoms of most common chronic diseases to some extent, but a considerable percentage of individuals with chronic diseases do not follow their prescribed treatments (Osterberg & Blaschke, 2005), which weakens the effectiveness of available medical care. Some people even after available treatment care are sloppy in its use but some are able to adjust to the illness over a period of time, which means diabetes is not always associated with psychiatric and psychological problems. Many studies have shown that people tend to regain their earlier levels of well-being after negative life events (Clark et al. 2008; Powdthavee, 2009; Davydov et al., 2010), although this is not always the case (Headey, 2010). Previous studies have reported declining levels of extraversion, conscientiousness and openness to experience with age (Lucas & Donnellan, 2011; Wortman et al. 2012). On the other hand, emotional stability and related traits have been shown to increase (Wortman et al., 2012) or remain stable (Lucas & Donnellan, 2011) in adulthood at least up to the age of 70 years, after which levels of negative affectivity may increase again (Baird et al., 2010; Jokela et al., 2013). This could be because of difficulty in coping with the emotional, behavioral and cognitive challenges. Therefore, understanding personality and its relation to disease onset and management is of supreme importance in planning successful intervention strategies in person with diabetes. Personality traits also help a clinician to understand whether the person will be successful in managing diabetes and its aging related consequences or not because as we age our personality forms a rigid habit and changing these

364

 Diabetes Mellitus and Aging

habits in old age is another complicated task as they are already facing additional problems because of aging. However, knowing about personality and its consequences can help a person to prevent perilous complication because of diabetes.

Comorbid Conditions Diabetes is often accompanied with a range of other illnesses and conditions, which further have a significant impact on its management. Dementia, Cognitive decline (Velayudhan et al., 2010), reduced muscle strength and quality (Volpato et al., 2012), disability (Volpato et al., 2003; Gregg et al., 2000), falls and fall-related morbidity (Schwartz et al. 2002; Strotmeyer et al., 2005), urinary incontinence (Brown et al., 2006), these conditions are very frequent in older diabetic people, especially in the weak ones. When present they exert a negative effect on the mental health, quality of life and mortality. It is a known risk factor for tuberculosis (Jeon & Murray, 2008) and is associated with poorer tuberculosis outcomes, while tuberculosis is associated with worsening glycemic control (Riza et al., 2014).Diabetes Mellitus is one of the leading causes of kidney failure, non-traumatic lower-limb amputations, and new cases of blindness among adults and is the seventh leading cause of death in the United States, killing more than 1.4 million people worldwide in 2011 (WHO, 2013).Ageing-related conditions such as decline in cognitive abilities and physical disability or decline in physical strength have emerged as frequent co-morbid conditions with diabetes. Depression is two to three times more common in people with diabetes than in those without depression (Roy & Lloyd, 2012). Nefs et al. (2012) showed that 66% of individuals with type 2 diabetes who had a high depression score, still had a high score two to three years later. Furthermore, multiple studies have linked depression to a variety of adverse health outcomes among individuals with type 2 diabetes, like a reduced quality of life (Schram et al., 2009), less optimal self-care behaviors and higher HbA1c levels (Pouwe et al., 2013), a higher risk of micro- and macrovascular complications (De Groot et al., 2001), higher mortality rates (Van Dooren et al., 2013) and increased health care costs (Hutter et al., 2010). Similar to depression, anxiety disorders typically have a chronic and recurrent life course, elevated anxiety symptoms and disorders in type 2 diabetes have been associated with reduced quality of life (Chyun et al., 2006), poor glycemic control (Lloyd et al., 2000; Balhara&Sagar, 2011) and diabetes complications (Collins et al., 2009). The increasing longevity of HIV/AIDS patients is accompanied by a rising incidence and prevalence of insulin resistance and type 2 diabetes, some of which may be related to antiretroviral treatment (Oni et al. 2015; Reid et al., 2012). Co-morbidity of psychiatric disorder with diabetes shares a bidirectional association. Both the disorder can be present independently or can be co-morbid. Various biological and psychological conditions contribute to the emergence of psychiatric disorders.

Life Style Poor life style such as; poor nutrition, overweight, increased rates of poor health behaviors such as smoking and alcohol consumption, stress, and limited access to health care, particularly in middle age when many individuals are at highest risk for developing diabetes (Buddy, 2006; Klein, 2011). Most lifestyle factors are related to depression as well and have adverse health outcomes in diabetes. Adults with Diabetes are generally seen as a high-risk group partially because they experience many stressful

365

 Diabetes Mellitus and Aging

changes in their lives, such as searching for a job, adjustment and establishing relationships (Peters & Laffel, 2011; Arnett, 2000). Such demands could interfere and even distract from focused diabetes management and a particular life style. Preventing complications and minimizing the risk of early mortality require modifications of lifestyle behaviors (Mondesir et al., 2015; Lipscombe et al., 2016). This treatment involves adherence to medication, improved diet, active lifestyle, self-monitoring blood glucose level, and good communication with health-care professionals.

DIABETICS AND MENTAL HEALTH Diabetes is a life-long chronic medical condition that requires regular self-management. This situation affects the emotional and psychological well-being of the individual. Whole life pattern changes when a person comes to know about his illness; alteration in the pattern of eating habits, self-care, how much insulin is required, when and what kind of exercise to be done, how to interpret a glucose reading and so on. The “psychological burden hypothesis” states that the burden of knowing that one has diabetes, the management of having a chronic illness, or having complications to cope with, contribute to higher levels of depression (Talbot &Nouwen, 2000). A meta-analysis showed that the occurrence of depression was particularly increased in known type 2 diabetes, but not in persons with screen-detected type 2 diabetes (who were unaware about the diabetes) (Nouwen et al., 2011). Self-management in diabetes is known to be burden to the elderly person, as it requires constant effort to adapt every day activities like diet, exercise and rest, to medication use and glucose levels (Sullivan et al., 2005). Insulin therapy may be associated with increased psychological distress (Delahanty et al., 2007) because it becomes difficult to accept that they have to shift from oral medication to insulin. This can also cause functional limitations like reduced mobility, visual impairments, fatigue, pain and also poor quality of life (Rubin et al., 1999). Managing diabetes in everyday of life is not an easy task, it makes a person more frustrated and depressed. When we talk about mental health, families and relationships have a significant role to play. However, having Type II diabetes changes life and affects the relationships as well. Diabetes management requires a lot of focus and attention which further becomes a responsibility for a spouse or a partner. A recent study of people whose partner had type II diabetes found that those who tried to exert control over their partner’s dietary habit felt particularly stressed and burdened (Cornelis et al., 2013). The emotional strain of dealing will diabetes can cause stress and anxiety as well as communication difficulties that can lead to sexual dysfunction in relationship (Azuamah et al., 2012). People with diabetes seek mental health professional’s help because of the difficulty to deal with the diabetes changes and the way it hampers the mental health. Staying with the treatment plan and taking care of themselves becomes important for some people but for other people it becomes an obstacle in living a life, the way they want to, which results in depression, anxiety, frustration and helplessness.

GENDER PERSPECTIVE Type 2 diabetes mellitus is a chronic disease affecting 9.7 million women and 10.9 million men among middle age and older adults in United States (Correa-de-Araujo et al., 2006; Mondesir et al., 2015). Middle aged diabetics are more than half and incidence rises with increasing ages in both genders, reach-

366

 Diabetes Mellitus and Aging

ing highest rates in the very old women. However, globally more males are diagnosed with diabetes. Social factors, like low educational level, occupation and income largely contribute to unhealthy lifestyle behavior and thus are related to higher risk of diabetic mellitus particularly in women (Lee et al., 2013; Kautzky-Willer et al., 2012). The psychological component like unpaid housework and responsibilities in the family may contribute to feelings of conflicting demands and sustained stress levels in females, even in highly educated groups of employees (Lundberg, 2005; Berntsson et al., 2006). Discrimination, biasness, roles and responsibilities may further increase the environmental psychosocial stress and stress responses especially in women. There is a significant difference in the way both genders experiences and manages diabetes, particularly in their beliefs, attitudes, fears and concerns about the disease. Women more often than men, view diabetes as negatively affecting their lives. At diagnosis, more women reported fearing loss of health, diabetes-related morbidity, and early mortality compared to men. Women report significantly more depressive symptoms, which can lower their participation in diabetes education and medication compliance (Park et al., 2004). Men are more concerned that diabetes will limit their lifestyles but also believes that it is controllable. Men report being more concerned about how diabetes affects their role, whereas women worry more about how self-care will hinder their familial responsibilities, and they also tend to sacrifice their dietary regimen for their family’s food preferences (Mathew et al., 2012). So, the biggest hurdle to the diabetes management among women might include lack of self-confidence, aging related other complications and inadequate family and social support.

MANAGEMENT OF DIABETES IN AGING A person diagnosed with diabetic mellitus can live a healthy and well-balanced life if proper and healthy life style has been followed. In comparison to type 1 diabetes, type 2 diabetes is largely preventable. There are some pharmacological and non-pharmacological approaches for the management of diabetes in aging;

Pharmacological Approach Type 1 diabetes cannot be prevented with current knowledge. Effective therapeutic techniques are available to prevent or to cope with type 2 diabetes. Evidence suggests that both aging and environmental factors contribute to the high prevalence of diabetes in the elderly. Clinical management of diabetes in elderly presents challenges because of the multifaceted geriatric scenario. It significantly lowers the chances of “successful” aging. So, optimizing medicine approach is essential in the care of an older person with diabetes. In line with the Quality Use of Medicines Framework, three key steps should be considered in drug prescription: 1) to identify the best treatment (considering non-pharmacological measures whenever possible); 2) to select medicines cleverly (considering the possibility of serious adverse effects or drug-to-drug interactions); and 3) to use medicines based on the strongest clinical evidences (Hilmer et al., 2007). Likewise, three subgroups of older patients should be considered: 1) those who are relatively healthy; 2) those with complex medical histories in whom self-care may be difficult, and 3) those with a significant comorbidities and functional impairment (Blaum et al., 2010; Laiteerapong et al., 2012). Thus, clinicians caring for older diabetic patients have to solve a therapeutic dilemma: balancing the patient’s needs while taking into consideration health profile and glycemic goals and avoiding adverse effects.

367

 Diabetes Mellitus and Aging

Non-Pharmacological Approach Aging mirrors all the changes that occur over the course of life. We grow and reach to maturity. To the young, aging is exciting but middle age also is the time when people begin to notice a fair amount of physical decline. Even the physically fit cannot escape from these changes. These process of aging goes through various physical and mental changes and also accompany various medical and mental health complications. Diabetes is so prevalent that aging and developing diabetes is almost synonymous in current scenario. So, when we talk about the non-pharmacological management of diabetes the primary input to this is healthy life style for everyone similar to primary prevention, regardless of any age or any medical condition like diabetes, such as, exercising regularly, healthy eating habit, avoiding smoking, and controlling blood pressure and lipids can prevent various complications in patients with diabetes. Another form of managing diabetes in elderly is psychotherapy in which various therapeutic approaches like CBT, relaxation exercises, mindfulness meditations, stress and tension reduction techniques can improve the mental health of the person aging with diabetes. Family therapy can play a vital role in reducing the care giver burden, helping them to understand the diabetic condition associated with aging. Solutions focused and behavioral management can be helpful in handling the present condition or problem where the issues of financial burden can be managed. Healthy coping and positive attribution can be incorporated in the management plan. Personality is dynamic in nature and not a static component. So, working on unhealthy personality traits and habits can improve the diabetic condition in elderly. Studies have shown that group-based diabetes self-management education (DSME) in people with type 2 diabetes results in improvements in clinical, lifestyle and psychosocial outcomes (Steinsbekk et al., 2012). So, psychotherapeutic management for diabetes and associated conditions can prevent various catastrophic consequences of diabetes mellitus in elderly.

SOLUTIONS AND RECOMMENDATIONS There are number of ways to offset some of the venomous effects of diabetes and aging, further can add healthy days in the older years. Before following the below mentioned recommendations it is important to understand that elderly with diabetes is not the only condition that affects the physical and mental health because there are many associated old age changes and diabetes is only one additional factor to the fixed changes that occurs in aging. These recommendations are; • • •

368

It is Important to have a regular monitoring of blood glucose levels of elderly, especially for those who are prone to additional complications of diabetes. Maintain a standard body weight because obesity contributes significantly to not only diabetes, but also to various other medical conditions like heart disease, stroke, and osteoarthritis. Be physically and mentally active because that can counter many effects of aging. Physical activities like regular exercises such as running, walking, bicycling, and swimming, is known to help maintaining blood glucose levels in people with diabetes. Similarly, staying mentally active is important too. It incorporates staying connected with your surroundings, maintaining good interpersonal relationships, and an effort to learn new things. The physical exercises of the elderly should be under consulting physician’s supervision.

 Diabetes Mellitus and Aging

•

• • • • •

• • • • •

It is recommended by WHO (2010) that adults aged 18–64 years should do at least 150 minutes of moderate-intensity aerobic physical activity (for example brisk walking, jogging, gardening) spread throughout the week, or at least 75 minutes of vigorous-intensity aerobic physical activity throughout the week, or an equivalent combination of moderate- and vigorous-intensity activity. For older adults the same amount of physical activity is recommended, but should also include balance and muscle strengthening activity tailored to their ability and circumstances (WHO, 2010). Maintain or practice healthy eating style because what you eat will determine how you age. Elderly with diabetes should maintain a proper meal plan in order to maintain appropriate weight, improve the blood glucose level and control the blood lipid levels. Practicing meditation and yoga helps improve the mental and physical health of all ages. Adding this habit to aging population can prevent various additional hurdles to healthy aging. Have a sound sleep because inadequate sleep can directly affect the physical health because sleep deprivation can lead to insulin resistance, which can make diabetes more difficult to control and may even raise the risk of heart disease. Keep a check on medicines and the prescribed doses and related side effects. This will require a regular check up to the consulting doctor because this can prevent any major catastrophe. This includes regular medical checkups, eye examinations, kidney tests, foot exams, dentist office visits, and vaccinations etc. Stick to a particular doctor because he will be aware of your disease progress report. Changing the doctors affects the routine management that an elderly diabetic requires. Stop unhealthy practices like smoking and drinking because smoking ages the tissues of the body and drinking may cause various cardiovascular disease, bone loss and psychiatric conditions such as depression, sleep problems and anxiety. Cognitive Behavior Therapy (CBT) can be an effective mode of management for treating comorbid depression and other psychiatric and psychological conditions in diabetic patients. Mindfulness-based stress reduction techniques can also be an effective mode of management in elderly. Provide a supportive environment (family and social) to the aging population with diabetes which can play an essential role to have a healthy aging with diabetes. All that they required is affection, care and respect.

CONCLUSION Aging is unavoidable and so are some diseases or medical conditions. However, a person can have some control over how well he/she can age. Access to adequate health care plays an even stronger role in controlling diabetes, preventing the development of complications to aging. By doing few things a person can stop or decrease the devastating effects associated with age and diabetes and can live an energetic life. There is no single policy or intervention that can ensure or prevent the effect of diabetic mellitus. It requires a holistic approach. Social, psychological and economical determinants of health and diabetes need to be considered when focusing on improving diabetes outcomes. You’re going to carry this illness for the rest of your life. So you can either wallow in the weight of that, or you can fight for your only life and make it a good story. …LyssTrayers

369

 Diabetes Mellitus and Aging

REFERENCES American Diabetes Association. (2014). Diagnosis and classification of diabetes mellitus. Diabetes Care, 37(1), 81-90. Anderson, R. J., Freedland, K. E., Clouse, R. E., & Lustman, P. J. (2001). The prevalence of comorbid depression in adults with diabetes: A meta-analysis. Diabetes Care, 24(6), 1069–1078. doi:10.2337/ diacare.24.6.1069 PMID:11375373 Arnett, J. J. (2000). Emerging adulthood: A theory of development from the late teens through the twenties. The American Psychologist, 55(5), 469–480. doi:10.1037/0003-066X.55.5.469 PMID:10842426 Azuamah, Y. C., Imaseun, A. F., Onoseta, O. H., & Onuoha, P. C. (2013). A review of sociological factors associated with diabetes mellitus. The International Journal of Social Sciences (Islamabad), 11(1), 131–137. Baird, B. M., Lucas, R. E., & Donnellan, M. B. (2010). Life satisfaction across the lifespan: Findings from two nationally representative panel studies. Social Indicators Research, 99(2), 183–203. doi:10.100711205-010-9584-9 PMID:21113322 Balhara, Y. P., & Sagar, R. (2011). Correlates of anxiety and depression among patients with type 2 diabetes mellitus. Indian Journal of Endocrinology and Metabolism, 15(5 Suppl. 1), S50–S54. doi:10.4103/22308210.83057 PMID:21847456 Bastid, E., & Pagan, J. A. (2002). Impact of Diabetes on adult employment and earning of Mexican American finding from a community based study. Health Economics, 11(5), 403–413. doi:10.1002/ hec.676 PMID:12112490 Berntsson, L., Lundberg, U., & Krantz, G. (2006). Gender differences in work-home interplay and symptom perception among Swedish white-collar employees. Journal of Epidemiology and Community Health, 60(12), 1070–1076. doi:10.1136/jech.2005.042192 PMID:17108304 Blaum, C., Cigolle, C. T., Boyd, C., Wolff, J. L., Tian, Z., Langa, K. M., & Weir, D. R. (2010). Clinical complexity in middle-aged and older adults with diabetes: The Health and Retirement Study. Medical Care, 48(4), 327–334. doi:10.1097/MLR.0b013e3181ca4035 PMID:20355264 Brown, J. S., Vittinghoff, E., Lin, F., Nyberg, L. M., Kusek, J. W., & Kanaya, A. M. (2006). Prevalence and risk factors for urinary incontinence in women with type 2 diabetes and impaired fasting glucose: Findings from the National Health and Nutrition Examination Survey (NHANES) 2001-2002. Diabetes Care, 29(6), 1307–1312. doi:10.2337/dc05-2463 PMID:16732013 Brown, S. A., Upchurch, S., Anding, R., Winter, M., & Ramirez, G. (1996). Promoting weight loss in Type II diabetes. Diabetes Care, 19(3), 613–624. doi:10.2337/diacare.19.6.613 PMID:8725861 Browne, J. L., Ventura, A., Mosely, K., & Speight, J. (2013). I call it the blame and the shame disease: A qualitative study about perceptions of social stigma surrounding type 2 diabetes. BMJ Open, 3(11), 1–10. doi:10.1136/bmjopen-2013-003384 PMID:24247325

370

 Diabetes Mellitus and Aging

Bryant, T., Daiski, I., & Lines, E. (2010). Type 2 diabetes: poverty, priorities and policy: the social determinants of the incidence and management of Type 2 diabetes [monograph on the Internet] Toronto, Ontario, Canada: York University School of Health Policy and Management; Retrieved March 16, 2017 from www.hpclearinghouse.ca/pdf/Diabetes%20Fact%20Sheet%202010%20-%20March%2016%20-%20 final%20.pdf Bryden, K. S., Dunger, D. B., Mayou, R. A., Peveler, R. C., & Neil, H. A. (2003). Poor prognosis of young adults with type 1 diabetes: A longitudinal study. Diabetes Care, 26(4), 1052–1057. doi:10.2337/ diacare.26.4.1052 PMID:12663572 Buddy, T. (2006). Drinking alcohol and diabetes. Retrieved from http://alcoholism.about.com Centorrino, F., Mark, T. L., Talamo, A., Oh, K., & Chang, J. (2009). Health and economic burden of metabolic comorbidity among individuals with bipolar disorder. Journal of Clinical Psychopharmacology, 29(6), 595–600. doi:10.1097/JCP.0b013e3181bef8a6 PMID:19910727 Chen, L., Magliano, D. J., & Zimmet, P. Z. (2011). The worldwide epidemiology of type 2 diabetes mellitus--present and future perspectives. Nature Reviews. Endocrinology, 8(4), 228–236. doi:10.1038/ nrendo.2011.183 PMID:22064493 Chyun, D. A., Melkus, G. D., Katten, D. M., Price, W. J., Davey, J. A., & Grey, N. (2006). The association of psychological factors, physical activity, neuropathy, and quality of life in type 2 diabetes. Biological Research for Nursing, 7(4), 279–288. doi:10.1177/1099800405285748 PMID:16581898 Clark, A. E., Diener, E., Georgellis, Y., & Lucas, R. E. (2008). Lags and leads in life satisfaction: A test of the baseline hypothesis. Economic Journal (London), 118(529), F222–F243. doi:10.1111/j.14680297.2008.02150.x Collins, M. M., Corcoran, P., & Perry, I. J. (2009). Anxiety and depression symptoms in patients with diabetes. Diabetic Medicine, 26(2), 153–161. doi:10.1111/j.1464-5491.2008.02648.x PMID:19236618 Conti, C., Carrozzino, D., Patierno, C., Vitacolonna, E., & Fulcheri, M. (2016). The Clinical Link between Type D Personality and Diabetes. Frontiers in Psychiatry, 7, 113. doi:10.3389/fpsyt.2016.00113 PMID:27445869 Cooper, H. C., Booth, K., & Gill, G. (2003). Patients’ perspectives on diabetes health care education. Health Education Research, 18(2), 191–206. doi:10.1093/her/18.2.191 PMID:12729178 Cornelis, M. C., Glymour, M., Kawachi, I., & Chivue, S. (2013). Marital status and risk of type 2 diabetes in the health professionals. American Heart Foundation. Retrieved from http://www.ahajournals.org Correa-de-Araujo, R., McDermott, K., & Moy, E. (2006). Gender differences across racial and ethnic groups in the quality of care for diabetes. Women’s Health Issues, 16(2), 56–65. doi:10.1016/j. whi.2005.08.003 PMID:16638522 Das-Munshi, J., Stewart, R., Ismail, K., Bebbington, P. E., Jenkins, R., & Prince, M. J. (2007). Diabetes, common mental disorders, and disability: Findings from the UK National Psychiatric Morbidity Survey. Psychosomatic Medicine, 69(6), 543–550. doi:10.1097/PSY.0b013e3180cc3062 PMID:17636148

371

 Diabetes Mellitus and Aging

Davydov, D. M., Stewart, R., Ritchie, K., & Chaudieu, I. (2010). Resilience and mental health. Clinical Psychology Review, 30(5), 479–495. doi:10.1016/j.cpr.2010.03.003 PMID:20395025 Delahanty, L. M., Grant, R. W., Wittenberg, E., Bosch, J. L., Wexler, D. J., Cagliero, E., & Meigs, J. B. (2007). Association of diabetes-related emotional distress with diabetes treatment in primary care patients with Type 2 diabetes. Diabetic Medicine, 24(1), 48–54. doi:10.1111/j.1464-5491.2007.02028.x PMID:17227324 Denollet, J. (2005). DS14: Standard assessment of negative affectivity, social inhibition, and Type D personality. Psychosomatic Medicine, 67(1), 89–97. doi:10.1097/01.psy.0000149256.81953.49 PMID:15673629 Dolan, P., & White, M. P. (2007). How can measures of subjective well-being be used to inform public policy? Perspectives on Psychological Science, 2(1), 71–84. doi:10.1111/j.1745-6916.2007.00030.x PMID:26151920 Fontbonne, A., Berr, C., Ducimetiere, P., & Alperovitch, A. (2001). Changes in cognitive abilities over a 4-year period are unfavorably affected in elderly diabetic subjects: Results of the epidemiology of vascular aging study. Diabetes Care, 24(2), 366–370. doi:10.2337/diacare.24.2.366 PMID:11213894 Global Burden of Disease (GBD). (2013). Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 79 behavioral, environmental and occupational, and metabolic risks or clusters of risks in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet, 386, 2287–323. Goldney, R. D., Phillips, P. J., Fisher, L. J., & Wilson, D. H. (2004). Diabetes, depression, and quality of life: A population study. Diabetes Care, 27(5), 1066–1070. doi:10.2337/diacare.27.5.1066 PMID:15111522 Gonzalez, J. S., Safren, S. A., Cagliero, E., Wexler, D. J., Delahanty, L., Wittenberg, E., ... Grant, R. W. (2007). Depression, self-care, and medication adherence in type 2 diabetes: Relationships across the full range of symptom severity. Diabetes Care, 30(9), 2222–2227. doi:10.2337/dc07-0158 PMID:17536067 Gredig, D., & Bartelsen-Raemy, A. (2016). Diabetes-related stigma affects the quality of life of people living with diabetes mellitus in Switzerland: implications for healthcare providers. Journal of Health & Social Care in the Community. doi.10.1111/hsc.12376 Gregg, E. W., Beckles, G. L., Williamson, D. F., Leveille, S. G., Langlois, J. A., Engelgau, M. M., & Narayan, K. M. (2000). Diabetes and physical disability among older U.S. adults. Diabetes Care, 23(9), 1272–1277. doi:10.2337/diacare.23.9.1272 PMID:10977018 Gregg, E. W., Mangione, C. M., Cauley, J. A., Thompson, T. J., Schwartz, A. V., Ensrud, K. E., & Nevitt, M. C. (2002). Diabetes and incidence of functional disability in older women. Diabetes Care, 25(1), 61–67. doi:10.2337/diacare.25.1.61 PMID:11772902 Gregg, E. W., & Narayan, K. M. V. (2000). Type 2 diabetes and cognitive function: Are cognitive impairment and dementia complications of type 2 diabetes? Clinics in Geriatric Medicine, 8, 57–72. Grunnet, J. (2008). Heredity and Diabetes. Annals of Internal Medicine, 6(10), 1272–1274. Headey, B. (2010). The set point theory of well-being has serious flaws: On the eve of a scientific revolution? Social Indicators Research, 97(1), 7–21. doi:10.100711205-009-9559-x 372

 Diabetes Mellitus and Aging

Hilmer, S. N., McLachlan, A. J., & Le Couteur, D. G. (2007). Clinical pharmacology in the geriatric patient. Fundamental & Clinical Pharmacology, 21(3), 217–230. doi:10.1111/j.1472-8206.2007.00473.x PMID:17521291 Holt, R. I., & Katon, W. J. (2012). Dialogue on Diabetes and Depression: Dealing with the double burden of co-morbidity. Journal of Affective Disorders, 142, S1–S3. doi:10.1016/S0165-0327(12)00632-5 PMID:23062852 In Holt, R. I. G., de Groot, M., & Huang, E. S. (2007). Appropriate application of evidence to the care of elderly patients with diabetes. Current Diabetes Reviews, 3(4), 260–263. doi:10.2174/1573399810703040260 PMID:18220684 Huskamp, H. A., Kaufmann, C., & Stevenson, D. G. (2011). The intersection of long-term care and end-of-life care. Medical Care Research and Review, 69(1), 3–44. doi:10.1177/1077558711418518 PMID:21903662 Hutter, N., Schnurr, A., & Baumeister, H. (2010). Healthcare costs in patients with diabetes mellitus and comorbid mental disorders--a systematic review. Diabetologia, 53(12), 2470–2479. doi:10.100700125010-1873-y PMID:20700575 International Diabetes Federation (IDF). (2013). Diabetes (6th ed.). Brussels: Atlas. Jacobs, P., & Johnson, J. A. (2001). Productivity Losses Associated with Diabetes in the US. Diabetes Care, 24(3), 257–261. PMID:11213875 Jeon, C. Y., & Murray, M. B. (2008). Diabetes mellitus increases the risk of active tuberculosis: A systematic review of 13 observational studies. PLoS Medicine, 5(7), e152. doi:10.1371/journal.pmed.0050152 PMID:18630984 Jokela, M., Batty, G. D., & Kivimäki, M. (2013). Ageing and the prevalence and treatment of mental health problems. Psychological Medicine, 43(10), 2037–2045. doi:10.1017/S0033291712003042 PMID:23324208 Kautzky-Willer, A., Dorner, T., Jensby, A., & Rieder, A. (2012). Women show a closer association between educational level and hypertension or diabetes mellitus than males: A secondary analysis from the Austrian HIS. BMC Public Health, 12(1), 392. doi:10.1186/1471-2458-12-392 PMID:22646095 Klein, J. (2011). How lifestyle habits affect diabetes. Retrieved from http://www.Life.guiam.com Krag, M. O., Hasselbalch, L., Siersma, V., Nielsen, A. B., Reventlow, S., Malterud, K., & de Fine Olivarius, N. (2016). The impact of gender on the long-term morbidity and mortality of patients with type 2 diabetes receiving structured personal care: A 13 year follow-up study. Diabetologia, 59(2), 275–285. doi:10.100700125-015-3804-4 PMID:26607637 Krishnam, S., Cozier, Y., Rosenberg, L., & Palmer, J. (2009). Socioeconomic status and incidence of type 2 diabetes: Results from the black women’s health study. American Journal of Epidemiology, 171(5), 564–570. doi:10.1093/aje/kwp443 PMID:20133518 Kumar, V., Fausto, N., & Abbas, A. (2008). Pathologic Basis of Disease (7th ed., pp. 1189–1206). Saunders Company.

373

 Diabetes Mellitus and Aging

Laiteerapong, N., Iveniuk, J., John, P. M., Laumann, E. O., & Huang, E. S. (2012). Classification of older adults who have diabetes by comorbid conditions, United States, 2005-2006. Preventing Chronic Disease, 9, 3–8. PMID:22595321 Lee, D. S., Kim, Y. J., & Han, H. R. (2013). Sex differences in the association between socio-economic status and type 2 diabetes: Data from the 2005 Korean National Health and Nutritional Examination Survey (KNHANES). Public Health, 127(6), 554–560. doi:10.1016/j.puhe.2013.02.001 PMID:23706862 Lipscombe, C., Smith, K. J., Gariepy, G., & Schmitz, N. (2016). Gender differences in the association between lifestyle behaviors and diabetes distress in a community sample of adults with type 2 diabetes. Journal of Diabetes, 8(2), 269–278. doi:10.1111/1753-0407.12298 PMID:25850582 Lloyd, C. E., Dyer, P. H., & Barnett, A. H. (2000). Prevalence of symptoms of depression and anxiety in a diabetes clinic population. Diabetic Medicine, 17(3), 198–202. doi:10.1046/j.1464-5491.2000.00260.x PMID:10784223 Lucas, R. E., & Donnellan, M. B. (2011). Personality development across the life span: Longitudinal analyses with a national sample from Germany. Journal of Personality and Social Psychology, 101(4), 847–861. doi:10.1037/a0024298 PMID:21707197 Luchsinger, J. A., Tang, M., Stern, Y., Shea, S., & Mayeux, R. (2001). Diabetes mellitus and risk of Alzheimer’s disease and dementia with stroke in a multiethnic cohort. American Journal of Epidemiology, 154(7), 635–641. doi:10.1093/aje/154.7.635 PMID:11581097 Lundberg, U. (2005). Stress hormones in health and illness: The roles of work and gender. Psychoneuroendocrinology, 30(10), 1017–1021. doi:10.1016/j.psyneuen.2005.03.014 PMID:15963652 Lustman, P. J., Anderson, R. J., Freedland, K. E., de Groot, M., Carney, R. M., & Clouse, R. E. (2000). Depression and poor glycemic control: A meta-analytic review of the literature. Diabetes Care, 23(7), 934–942. doi:10.2337/diacare.23.7.934 PMID:10895843 Mathew, R., Gucciardi, E., De Melo, M., & Barata, P. (2012). Self-management experiences among men and women with type 2 diabetes mellitus: A qualitative analysis. BMC Family Practice, 13(1), 122. doi:10.1186/1471-2296-13-122 PMID:23249410 Mondesir, F. L., White, K., Liese, A. D., & McLain, A. C. (2015). Gender, illness-related diabetes social support, and glycemic control among middle-aged and older adults. The Journals of Gerontology. Series B, Psychological Sciences and Social Sciences, 71(6), 1081–1088. doi:10.1093/geronb/gbv061 PMID:26307487 Naeem, A. G. (2003). The role of culture and religion in the management of diabetes: A study of Kashiri men in Leeds. The Journal of the Royal Society for the Promotion of Health, 123(2), 110–116. doi:10.1177/146642400312300216 PMID:12852196 National Diabetes Statistics. (2011). Department of Health and Human Services. National Institutes of Health. Hill, J., Nielsen, M., & Fox, M. H. (2013). Understanding the Social Factors That Contribute to Diabetes: A Means to Informing Health Care and Social Policies for the Chronically Ill. The Permanente Journal, 17(2), 67–72. doi:10.7812/TPP/12-099 374

 Diabetes Mellitus and Aging

NCD Risk Factor Collaboration (NCD-RisC). (2016). Worldwide trends in diabetes since 1980: a pooled analysis of 751 population-based studies with 4*4 million participants. Lancet. doi:.10.1016/S01406736(16)00618-8 Nefs, G., Pouwer, F., Denollet, J., & Pop, V. (2012). The course of depressive symptoms in primary care patients with type 2 diabetes: Results from the Diabetes, Depression, Type D Personality Zuidoost-Brabant (DiaDDZoB) Study. Diabetologia, 55(3), 608–616. doi:10.100700125-011-2411-2 PMID:22198261 Nefs, G., Pouwer, F., Pop, V., & Denollet, J. (2012). Type D (distressed) personality in primary care patients with type 2 diabetes: Validation and clinical correlates of the DS14 assessment. Journal of Psychosomatic Research, 72(4), 251–257. doi:10.1016/j.jpsychores.2012.01.006 PMID:22405217 Nouwen, A., Nefs, G., Caramlau, I., Connock, M., Winkley, K., Lloyd, C. E., ... Pouwer, F. (2011). Prevalence of depression in individuals with impaired glucose metabolism or undiagnosed diabetes: A systematic review and meta-analysis of the European Depression in Diabetes (EDID) Research Consortium. Diabetes Care, 34(3), 752–762. doi:10.2337/dc10-1414 PMID:21357362 Oni, T., Youngblood, E., Boulle, A., McGrath, N., Wilkinson, R. J., & Levit, N. S. (2015). Patterns of HIV, TB, and noncommunicable disease multi-morbidity in peri-urban South Africa – a cross sectional study. BMC Infectious Diseases, 15(1), 20. doi:10.118612879-015-0750-1 PMID:25595711 Osterberg, L., & Blaschke, T. (2005). Adherence to medication. The New England Journal of Medicine, 353(5), 487–497. doi:10.1056/NEJMra050100 PMID:16079372 Ott, A., Stolk, R. P., Hofman, A., van Harskamp, F., Grobbee, D. E., & Breteler, M. M. (1996). Association of diabetes mellitus and dementia: The Rotterdam Study. Diabetologia, 39(11), 1392–1397. doi:10.1007001250050588 PMID:8933010 Park, H., Hong, Y., Lee, H., Ha, E., & Sung, Y. (2004). Individuals with type 2 diabetes and depressive symptoms exhibited lower adherence with self-care. Journal of Clinical Epidemiology, 57(9), 978–984. doi:10.1016/j.jclinepi.2004.01.015 PMID:15504641 Peters, A., & Laffel, L. (2011). Diabetes care for emerging adults: Recommendations for transition from pediatric to adult diabetes care systems. Diabetes Care, 34(11), 2477–2485. doi:10.2337/dc11-1723 PMID:22025785 Pouwer, F., Nefs, G., & Nouwen, A. (2013). Adverse effects of depression on glycemic control and health outcomes in people with diabetes: A review. Endocrinology and Metabolism Clinics of North America, 42(3), 529–544. doi:10.1016/j.ecl.2013.05.002 PMID:24011885 Powdthavee, N. (2009). What happens to people before and after disability? Focusing effects, lead effects, and adaptation in different areas of life. Social Science & Medicine, 69(12), 1834–1844. doi:10.1016/j. socscimed.2009.09.023 PMID:19833424 Raju, S. (2006). Ageing in India in the 21st Century: A Research Agenda. Mumbai: The Harmony Initiative. Reid, M. J. A., Tsima, B. M., & Kirk, B. (2012). HIV and diabetes in Africa. African Journal of Diabetes Medicine, 20(2), 28–32.

375

 Diabetes Mellitus and Aging

Riza, A. L., Pearson, F., Ugarte-Gil, C., Alisjahbana, B., van de Vijver, S., Panduru, N. M., ... van Crevel, R. (2014). Clinical management of concurrent diabetes and tuberculosis and the implications for patient services. The Lancet. Diabetes & Endocrinology, 2(9), 740–753. doi:10.1016/S2213-8587(14)70110-X PMID:25194887 Roy, T., & Lloyd, C. E. (2012). Epidemiology of depression and diabetes: a systematic review. Journal of Affective Disorders, 142(Suppl.), S8-21. Rubin, R. R., & Peyrot, M. (1999). Quality of life and diabetes. Diabetes/Metabolism Research and Reviews, 15(3), 205–218. doi:10.1002/(SICI)1520-7560(199905/06)15:33.0.CO;2-O PMID:10441043 Schram, M. T., Baan, C. A., & Pouwer, F. (2009). Depression and quality of life in patients with diabetes: A systematic review from the European depression in diabetes (EDID) research consortium. Current Diabetes Reviews, 5(2), 112–119. doi:10.2174/157339909788166828 PMID:19442096 Schwartz, A. V., Hillier, T. A., Sellmeyer, D. E., Resnick, H. E., Gregg, E., Ensrud, K. E., ... Cummings, S. R. (2002). Older women with diabetes have a higher risk of falls: A prospective study. Diabetes Care, 25(10), 1749–1754. doi:10.2337/diacare.25.10.1749 PMID:12351472 Schwartz, A. V., Sellmeyer, D. E., Ensrud, K. E., Cauley, J. A., Tabor, H. K., Schreiner, P. J., ... Cummings, S. R. (2001). Older women with diabetes have an increased risk of fracture: A prospective study. The Journal of Clinical Endocrinology and Metabolism, 86(1), 32–38. doi:10.1210/jcem.86.1.7139 PMID:11231974 Seuring, T., Archangelidi, O., & Suhrcke, M. (2015). The economic costs of type 2 diabetes: A global systematic review. PharmacoEconomics, 33(8), 811–831. doi:10.100740273-015-0268-9 PMID:25787932 Steinsbekk, A., Rygg, L., Lisulo, M., Rise, M. B., & Fretheim, A. (2012). Group based diabetes selfmanagement education compared to routine treatment for people with type 2 diabetes mellitus. A systematic review with meta-analysis. BMC Health Services Research, 12(1), 213. doi:10.1186/14726963-12-213 PMID:22824531 Strotmeye, E. S., Cauley, J. A., Schwartz, A. V., Nevitt, M. C., Resnick, H. E., Bauer, D. C., ... Newman, A. B. (2005). Nontraumatic fracture risk with diabetes mellitus and impaired fasting glucose in older white and black adults: The health, aging, and body composition study. Achieves International Medicine, 165(14), 1612–1617. doi:10.1001/archinte.165.14.1612 PMID:16043679 Sullivan, P. W., Morrato, E. H., Ghushchyan, V., Wyatt, H. R., & Hill, J. O. (2005). Obesity, inactivity, and the prevalence of diabetes and diabetes-related cardiovascular comorbidities in the U.S., 2000–2002. Diabetes Care, 28(7), 1599–1603. doi:10.2337/diacare.28.7.1599 PMID:15983307 Talbot, F., & Nouwen, A. (2000). A review of the relationship between depression and diabetes in adults: Is there a link? Diabetes Care, 23(10), 1556–1562. doi:10.2337/diacare.23.10.1556 PMID:11023152 United Nations Department of Economic and Social Affairs, Population Division. (2008). World Population Prospects (2008 Revision). Retrieved from http://esa.un.org/unpp/index.asp?panel=2

376

 Diabetes Mellitus and Aging

Van Dooren, F. E., Nefs, G., Schram, M. T., Verhey, F. R., Denollet, J., & Pouwer, F. (2013). Depression and risk of mortality in people with diabetes mellitus: A systematic review and meta-analysis. PLoS One, 8(3), e57058. doi:10.1371/journal.pone.0057058 PMID:23472075 Van Dooren, F. E. P., Denollet, J., Verhey, F. R. J., Stehouwer, C. D. A., Sep, S. J. S., Henry, R. M., ... Schram, M. T. (2016). Psychological and personality factors in type 2 diabetes mellitus, presenting the rationale and exploratory results from The Maastricht Study, a population-based cohort study. BMC Psychiatry, 16(1), 17. doi:10.118612888-016-0722-z PMID:26817600 Velayudhan, L., Poppe, M., Archer, N., Proitsi, P., Brown, R. G., & Lovestone, S. (2010). Risk of developing dementia in people with diabetes and mild cognitive impairment. The British Journal of Psychiatry, 196(1), 36–40. doi:10.1192/bjp.bp.109.067942 PMID:20044657 Volpato, S., Bianchi, L., Lauretani, F., Lauretani, F., Bandinelli, S., Guralnik, J. M., ... Ferrucci, L. (2012). Role of muscle mass and muscle quality in the association between diabetes and gait speed. Diabetes Care, 35(8), 1672–1679. doi:10.2337/dc11-2202 PMID:22596176 Volpato, S., Ferrucci, L., Blaum, C., Ostir, G., Cappola, A., Fried, L. P., ... Guralnik, J. M. (2003). Progression of lower-extremity disability in older women with diabetes: The Women’s Health and Aging Study. Diabetes Care, 26(1), 70–75. doi:10.2337/diacare.26.1.70 PMID:12502660 Weissberg-Benchell, J., & Antisdel-Lomaglio, J. (2011). Diabetes-specific emotional distress among adolescents: Feasibility, reliability, and validity of the problem areas in diabetes-teen version. Pediatric Diabetes, 12(4 Pt 1), 341–344. doi:10.1111/j.1399-5448.2010.00720.x PMID:21443583 World Health Organization (WHO). (2010). Global recommendations on physical activity for health. Geneva. World Health Organization (WHO). (2016). Global report on diabetes. Geneva. Wortman, J., Lucas, R. E., & Donnellan, M. B. (2012). Stability and change in the Big Five personality domains: Evidence from a longitudinal study of Australians. Psychology and Aging, 27(4), 867–874. doi:10.1037/a0029322 PMID:22775362

KEY TERMS AND DEFINITIONS Aging: A process of becoming older. Coping: The process of contending with life difficulties. Diabetes: A group of metabolic diseases. Life Style: The way in which a person lives. Medical Illness: Unhealthy condition of the body. Physical: Relating to things perceived through the senses and concrete in nature. Positive Psychology: An applied approach to optimal functioning. This research was previously published in the Handbook of Research on Geriatric Health, Treatment, and Care edited by Barre Vijaya Prasad and Shamsi Akbar, pages 269-287, copyright year 2018 by Medical Information Science Reference (an imprint of IGI Global). 377

378

Chapter 19

Health Guidance Provision Infrastructure for Personalized Diabetes Management: The HealthDiab Solution

Kostas Giokas AiM Research Team, Biomedical Engineering Laboratory, National Technical University of Athens, Greece Dimitra Iliopoulou AiM Research Team, Biomedical Engineering Laboratory, National Technical University of Athens, Greece Georgia Koutsouri AiM Research Team, Biomedical Engineering Laboratory, National Technical University of Athens, Greece Dimitris Koutsouris National Technical University of Athens, Greece

ABSTRACT Over the last 30 years, diabetes mellitus has changed from being seen as a relatively mild ailment associated with ageing and the elderly (‘just a touch of sugar’) to one of the major contemporary causes of premature mortality and morbidity in most countries. HealthDiab aims at proposing the development of an innovative personal health management system overcoming the current limitations patients and their physicians find at managing the disease. The central element for such system will be patient’s own daily health records, as base for the provision of personalised and real-time guidance in the treatment of diabetes. The proposed solution could easily be adopted as a commercial product by a company willing to bring an innovative and effective Personal Health Management technology platform into market. Such a platform could help reduce the risks for the patient by getting new comorbidities associated to their disease while helping decrease the billionaire public costs linked with health assistance in our European welfare states DOI: 10.4018/978-1-5225-7122-3.ch019

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Health Guidance Provision Infrastructure for Personalized Diabetes Management

INTRODUCTION Diabetes mellitus (or Diabetes) is a chronic disease which cannot be cured except in very specific situations. Its management concentrates on keeping blood sugar levels as close to normal (“euglycemia”) as possible, without causing hypoglycemia. This can usually be accomplished with diet, exercise, and use of appropriate medications (insulin in the case of type 1 diabetes, oral medications, as well as possibly insulin, in type 2 diabetes). Patient education, understanding, and participation is vital, since the complications of diabetes are far less common and less severe in people who have well-managed blood sugar levels (Stahl & Johansson, 2008). The goal of treatment is an HbA1C (“What is the hba1c,” 2014) level of 6.5%, but should not be lower than that, and may be set higher. Attention is also paid to other health problems or parameters that may accelerate the deleterious effects of diabetes. These include smoking, elevated cholesterol levels, obesity, high blood pressure, and lack of regular exercise (Research2Guidance, 2013). And although it is well proven that control of blood pressure and blood glucose and cholesterol levels can dramatically reduce diabetes complications (“WHO | Country and regional data on diabetes,” 2011; “WHO | Diabetes,” 2015; Wild, Roglic, Green, Sicree, & King, 2004), (TucsonMedicalCenter, 2015), which can be devastating (blindness, amputations, even death), the fact is that studies show that one of the main causes of associated-complications in diabetes is non-adherence to control and medication (Shamsi, Khodaifar, Arzaghi, Sarvghadi, & Ghazi, 2014). Alarmingly, it is estimated that less than 2% of adults with diabetes perform the full level of care (Beckles et al., 1998), which includes at least self-monitoring of blood glucose and dietary restrictions as well as medication use as recommended by their specialists (“Technology Assessment of the U.S. Assistive Technology Industry. Markets & Future Demand,” 2009). It is estimated that from 40% to 50% of blindness, kidney, and foot amputations cases could be prevented just by properly adhering to the glucose level controls. In addition, the proper control of blood pressure and diet could reduce cardiovascular complications (heart disease, strokes) by approximately 33% each (Sheang, Hua, & Jiuan, 2010). However taking good care of diabetes implies a big part should come from the diabetic patient him/ her-self. In their day-to-day a diabetic must calculate how much insulin he/she will take before each meal (and in relation to the previous ones during the day), test glucose at least six times a day, receive multiple injections and record their levels for continuous self-management and future appraisal with the physician. Up to the present day, diabetics have traditionally self-managed their disease through their own in-situ calculations, general guidelines and basic trial & error. There exists now the context for swifting this situation and related trends, mitigating the patients in their management of the disease, reducing impact of diabetes and its consequences and helping the health professionals in supporting patients, thanks to: • • •

New scientific advances in the understanding of diabetes, that are given as a result mathematical models to short-term predictions on glucose evolution (Georga, 2011); New understanding of complementary influence of several physiological parameters (blood glucose and pressure levels, physical activity, nutrition and, also, individual’s psychological condition), and emerging technologies for monitoring them; The continuous presence and innovations provided by of a variety of ICTs in our lives (great enablers for the implementation of systems involving mobility, ubiquity, reusability, communication, security and data gathering). 379

 Health Guidance Provision Infrastructure for Personalized Diabetes Management

These three elements put together are called to pave the way towards making possible the provision of effective tools to overcome the traditional limitations and obstacles that diabetics have to deal with their disease, as well as the prevention of its associated devastating complications. Our proposed solution is focused here, aiming at proposing the development of an innovative personal health management system overcoming the current limitations patients and their physicians find at managing the disease.

PERSONAL HEALTH MANAGEMENT AND MOBILE HEALTH There is an identifiable market opportunity within the Personal Health Management (PHM) market, specifically within the mHealth submarket addressed to diabetics. There exists a lack of tools for the provision of personalized guidance for a disease such as diabetes, which is really demanding from the patient in terms of self-management and treatment adherence (Nathan et al., 2005). Therefore this proposed solution represents a real capacitor for a relevant organisation to penetrate and gain a relevant position in the European and Global PHM market, increasing its presence in international markets and negotiation and cooperation opportunities with other players. Our proposed solution will impact in the market for Personal Health Management (PHM), which targets individualized treatment and care based on personal variation, which is experiencing a great growth. The PHM market is expected to create opportunities and challenges for traditional healthcare and emerging market participants. Only accounting for the US the market for personalized medicine is already $232 billion, and it is projected to grow 11% annually (PricewaterhouseCoopers, 2009). It is projected, also that it will grow to as much as $452 billion by 2015: The core diagnostic and therapeutic segment of the market - comprised primarily of pharmaceutical, medical device and diagnostics companies - is estimated at $24 billion and is expected to grow by 10%annually, reaching $42 billion by 2015. The personalized medical care portion of the market - including telemedicine, health information technology and disease management services offered by traditional health and technology companies - is estimated at $4 billion to $12 billion and could grow tenfold to over $100 billion by 2015 if telemedicine takes off. There exists a great market opportunity for high-tech products for personal assistance and care giving, and a growing demand of products and services aimed at consumers’ heightened awareness of their own health risks. HealthDiab will also impact in the mHealth market. The majority of today’s mHealth smartphone applications fall into the category of general health tracking and fitness tools. Generally these apps have a low to medium sophistication level in terms of range of functionality, usage of sensors, integration of medical services and linkage to existing medical databases. The main target group of those applications are health conscious people who want to track their health (for example: calorie consumption, weight, blood pressure, BMI (“Body Mass Index,” 2015) and exercise progress). Chronically ill people have not yet been the focus of today’s app developers. This will likely change with the entrance of traditional health industry players into the mHealth app market. With the potential for sophisticated monitoring, compliance, time-management and a host of other applications to improve healthcare delivery to chronically ill patients, mHealth is expected to bring significant advances in the management of chronic diseases.

380

 Health Guidance Provision Infrastructure for Personalized Diabetes Management

Figure 1 illustrates market potential for mobile applications, specific for chronic diseases and the size of the overall addressable market for patients with chronic diseases today. It is important to remark that amongst chronic diseases diabetes is ranked highest in terms of business potential for mHealth applications. There is supporting evidence that diabetes applications will become the most extended and usual assistive technologies among chronic diseases, and will definitely penetrate in the mHealth market within the next few years: • •

•

Target Group Size: According to OECD and WHO (“Dexcom,” 2015) there are 220 million patients growing by more than 5% every year. This means that diabetic patients represent one of the biggest groups amongst people with a chronic condition. Huge Costs Saving Potential: The direct costs per diabetic patient in Western countries like Germany, not including the cost of long-term care (nursing insurance), are between 4,000 and 5,000 € per year (CoDiM study) (NAIMIT Project, 2014). The indirect costs, which include loss of productivity and early retirement, amounted to more than 5,000 € per patient per year. One can envision lots of business cases built around reducing these costs, for example limiting the number of patients visiting physicians, better patient outcome because of more accurate doses of insulin, improved therapy decisions, better compliancy to a therapy plan and so on. A Small Inconsistency of Diabetes Patients and Smartphone Users by Age: The average age of a smartphone user is around 35-45 years. Whereas diabetes patients tend to be around 10 years older on average. The amount of overlap in comparison to a market such as health and fitness groups will have considerably less diabetic patients owning and using mobile apps.

Figure 1. Therapy fields that offer the Best Market Potential for mHealth solutions (WHO, 2014)

381

 Health Guidance Provision Infrastructure for Personalized Diabetes Management

• • •

Geographical Match: Diabetes is a disease that has started to spread into developing countries but the majority of diabetes patients are living in industrialized countries. Those countries, also show the highest penetration of smartphones. Excellent Use Case Potential: Diabetes applications provide the flexibility to manage patients diabetes any-time and any-where. They can help to keep track of blood glucose level, carb intake and insulin dose etc. First Proof of Concept: There are a few apps already available which provide the kind of user experience, backend integration with health care databases and access to expert and personalized guidance which are needed to deliver the promised benefits.

Finally, a secondary market for HealthDiab is assistive technologies (AT). We believe HealthDiab will impact positively in the market of AT, which is suffering different needs, what is seen as opportunities by the proposers. Global sales by companies producing AT products and services totaled more than 350 million Euros in year 2000 (“Body Mass Index,” 2015). Although sales worldwide are showing average annual growth rates equal to 10% approximately, evolution in sales rates vary importantly among different geographic areas, despite of the fact that demand is increasing steadily in all of them. Within this context, North America (USA, Mexico and Canada) shows the higher sales growth rates, followed by markets such as Asia & Pacific Rim, Africa and Central/South America; while Europe faces 4% sales loss rates in certain time periods. Furthermore, the number of European AT companies, mainly SMEs, has been decreasing for the last 20 years. European companies within all sectors of the AT Industry are facing heavy competition from US products, which are overtaking part of their market share and are pushing some of these companies to critical entrepreneurial positions. There exist other factors making difficult for the industry as a whole to prosper, even within positive market forces such as (DiAdvisor, 2014): • • • • • •

An increasing offer of new Adaptive Technologies based on ICT, which translates into stronger international competition; the prevalence of SMEs, focused on niche products; other problems such as hiring and retaining trained workforce; difficulties in attracting venture capital and other forms of investment; fragmentation between providers and consumers; and the disconnect between the AT Industry and certain technology needs not yet fulfilled.

ATs have been developed to meet an enormous range of needs, and there are currently a wide variety of assistive products. Just to give an example, a database called EASTIN (Eastin, 2014), the European Assistive Technology Information Network, includes information on over 50,000 assistive technology products available on the European market and over 5,000 manufacturers / suppliers. From this enormous variety, on the one hand, growth sectors are primarily products based on ICT such as computer accessories, telecommunications equipment, special software and products for controlling and signaling. On the other hand, some of the larger product categories in the market are wheelchairs, hearing aids, prostheses and orthoses, beds, walking aids, hoists and aids for incontinence and ostomy.

382

 Health Guidance Provision Infrastructure for Personalized Diabetes Management

European SMEs involved in the production and distribution of ICT Assistive Technologies for diabetics need to provide products capable of differentiating from foreign competitors through the development of superior technologies which are increasingly demanded by their markets.

STATE OF THE ART: INNOVATION OF THE PLATFORM State of the Art in Personalised Guidance on Diabetes and mHealth Diabetes Applications One of the most remarkable initiatives within this field is the EU funded project DIADVISOR (“Body Mass Index,” 2015), which started in 2008 and ended in 2012. It was aimed at developing a prediction based tool which used past and easily available information for therapy otimisation of type I and developed type II diabetes. However, DIADVISOR was focused on the use of additional sensors to provide really accurate blood glucose evolution scenario to the patient, and through web-based / online systems, allowing continuous monitoring and feedback by sensing of multiple variables. HealthDiab uses a different approach, focusing on the usefulness, personalized assistance and its readiness, researching on existing data-driven short-term prediction models, mostly used only at laboratory level, adapting them to provide patient with personalized guidance through its own smartphone any-time any-where. At this regard, Mobile apps for personal health management in diabetes are rapidly growing. Most of the currently available applications are aimed at providing the user with digital tracking on its blood measurements or insulin intake. This keeps similarities with some of the proposed capabilities of HealthDiab, especially in basic tracking features. Some of the most popular mhealth apps within this category are OnTrackDiabetes (“OnTrack Diabetes,” 2014), Dbees (“dbees.com – diabetes under control,” 2015), Dlife, SiDiary (“Biosensics,” 2015), Glucool (“Glucool,” 2015) or Glucose Buddy (“TFO,” 2015). However, it is important to remark that none of these popular and available apps has yet introduced any AI component nor personalized guidance capability. This makes HealthDiab highly differentiate from direct target competence products currently available in the mobile market. Nevertheless, there already exists a product in the market that has been the first in providing short-term prediction of glucose evolution to its patient through their mobile phone, this is WellDoC Diabetes APP (TucsonMedicalCenter, 2015). The current version of its application is based on the patient sending SMSs with its blood glucose, carbohydrates and insulin doses to WellDoc server and then receiving personalized responses from either a computer program or provider. HealthDiab’s approach differentiates from it in the avoidance of any sort of data connection in order to provide assistance, as well as the personalized guidance and diabetes complications predictor based on the entered data and the own smartphone’s accelerometer data. Technology already allows undertaking a proposed platform like HealthDiab. The main reason why there is almost none commercially available PHM system for diabetics with these features in our Mobile phones is that Large Multinational Companies from Meds and health sector have not moved that fast until now. However within the next 5 years, a major growth in this market is expected, which will be significantly pushed from LEs, trying to impose their proprietary ecosystems and major penetration in other market segments and chronic diseases. The current State of-the-Art does not allow diabetics avoiding the self-managing of their disease yet. However, HealthDiab goes a step forward from the current technical limitations and commercial products, creating a comprehensive tool that will highly simplify its management and that will pave the way toward its future complete automatization.

383

 Health Guidance Provision Infrastructure for Personalized Diabetes Management

Innovative Use of Short-Term Prediction Models Within an mHealth App Insulin-Dependent Diabetes Mellitus (IDDM) is a chronic disease characterized by the inability of the pancreas to produce sufficient amounts of insulin. Daily compensation of the deficiency requires 4–6 insulin injections to be taken daily, the aim of this insulin therapy being to maintain normoglycemia – i.e., a blood glucose level between 4 and 7 mmol/l. To determine the quantity and timing of these injections, various different approaches are used. Currently, mostly qualitative and semi-quantitative models and reasoning are used to design such a therapy. Glucose metabolism models are prerequisite to successfully maintain glucose levels inside normal levels. The models used to predict glucose trend are grouped into two main groups: • •

Data-Driven Models: Are less complex and model equations estimate the parameters on individual basis, based on experimental results. Conceptual Models: Conceptual models take into consideration multiple parameters including physiology and metabolic processes. Organs and tissues are treated as separate compartments and for each of them a different equation describes the metabolic and kinetic processes. Recently developed models are constructed by smaller sub-models that represent each separate organ or tissue and interact with each other.

These models are usually used to simulate an artificial pancreas calculating infusion rates of subcutaneous insulin infusion pumps and combine the output of models expressing the subcutaneous and interstitial insulin kinetics (Nucci & Cobelli, 2000). Other sub-models include meal ingredients absorption (Arleth, Andreassen, Orsini-Federici, Timi, & Benedetti, 2000) from the gastrointestinal tract and exercise models to represent the effect of physical activity on glucose concentration. Recently data driven glucose prediction models have been proposed in the literature, because of the simpler structure; their ability to process in real-time significant amount of data; and the flexibility to be personalized. The majority of the proposed methods are based on Auto-Regressive Moving Average (ARMA) models (Cescon & Johansson, 2014) and recently on Artificial Neural Networks (ANN) (Pappada, Cameron, & Rosman, 2008). Other studies proposed a hybrid model, simulating glucose to the blood after meals, combining an Artificial Neural Network (simulating glucose kinetics) and a real time learning algorithm (Daskalaki, Prountzou, Diem, & Mougiakakou, 2012). The majority of the above mentioned models are for Type 1 diabetic patients, while they have never studied and evaluated systematically. These models have proved its reliability at laboratory level, with an accuracy in their predictions of 9,5mg/dl (15minutes), 16mg/dl (30m) and 25mg/dl (60m). In HealthDiab we will undertake the research on how to implement these models for their practical application to patients through their mobile phones

METHODOLOGY: PROPOSED SOLUTION Based on patient’s own daily monitoring records, HealthDiab will provide him/her with real-time, personalized guidance to keep glucose within its optimal range, alerting when parameter thresholds are above/below limits, and giving advice on the prevention of disease complications. A description of the proposed solution and its components is provided as follows:

384

 Health Guidance Provision Infrastructure for Personalized Diabetes Management

Figure 2. Diary of insulin intake, ingested carbohydrates and blood glucose samples

1. Data Acquisition Module: This module will allow both manual and automatic data input by two means: a. Manually Entered Data: Comprehending the basic regular parameters any diabetic must self-manage and control in a diary in a daily basis: i. Blood Glucose Level ii. Nutrition iii. Insulin / Medication iv. Other parameters: HealthDiab will allow entering also other health parameters, such as blood pressure, weight or MBI. However, despite the fact that they can add more accuracy to the prediction; they will not be considered as essential. Despite they would improve the accuracy of the predictions, these sort of other parameters will be considered as ‘not essential’ in order to make the collection of user input as easy, simple and motivating as possible, avoiding rising new barriers to it. b. Automated Data Acquisition: 1) of patient’s blood glucose levels through its CGM and 2) of user physical activity, seamlessly and directly acquired by monitoring user’s smartphone accelerometer. HealthDiab introduces the use of advanced patter recognition algorithms for the transformation of this data into information about patient’s physical activity, being able to extract, at least: i. Number of steps, pace, their amplitude and altitude. ii. Physical activity duration. iii. Intensity, calculating calories the approximate calories burnt.

385

 Health Guidance Provision Infrastructure for Personalized Diabetes Management

2. Models and Records Tracking: Applying novel object modelling and simulation techniques the data received from the acquisition module is processed according to two main prediction models: a. Short-Term Glucose Evolution Model (STGEM): HealthDiab uses the data from the acquisition module to provide personalized advise on optimal insulin range and intake with a prediction horizon up to 60 minutes, and with an accuracy range in average from 10 ( 0.7 mg/dL 144166 X (Scr/0.7)-1.209 X (0.993)Age

399

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

If any CAM slows the progression of CKD over one-year, as measured by a decline in eGFR of less than 3 ml/min/1.73m2/year, this CAM would be regarded as effective. This parameter also could assess worsening kidney function from using CAM. If any CAM decreases the rate of eGFR of at least 5 ml/ min/1.73m2/year, it would harm the kidneys. Therefore, patients with kidney diseases should avoid using that CAM. A limitation of this method is that there are no definite cutoff points for either slow or fast progression of CKD in patients with different causes of CKD. The second method is to calculate the percent change in eGFR over 12 months as follows: Percent change in eGFR at 12 months = [(eGFR12mo – eGFRbaseline)/ eGFRbaseline] x 100% In 2014, the National Kidney Foundation proposed this method for calculating a surrogate marker for detecting earlier kidney failure, compared to measuring serum creatinine levels (Levey et al., 2014). This marker is suitable for a study conducted over a short period of time, or has a population with different causes of kidney diseases, or if it is assessing different interventions for slowing the progression of CKD. The cutoff points of 30% and 40% are recommended due to their association with the progression of CKD (Heerspink et al., 2014). Proteinuria is a further outcome to be considered. It is mainly caused by diabetic kidney disease or glomerular diseases. Diminished proteinuria can slow the progression of CKD. Recently, standard guidelines for CKD management recommend three standard methods to measure proteinuria; the urine dipstick test, the urine protein-to-creatinine ratio (PCR), and the urine albumin-to-creatinine ratio (ACR) (National Kidney Foundation, 2002; The National Collaborating Centre for Chronic Conditions, 2008; The Nephrology Society of Thailand, 2009). Table 2 shows cutoff points of proteinuria and albuminuria. Proteinuria is defined as at least 2+ urine dipstick protein measurements for diabetic patients or at least 1+ of urine dipstick protein measurement for non-diabetic patients (National Kidney Foundation, 2002; The Nephrology Society of Thailand, 2009). Many studies measure 24-hour urinary protein excretion rate (PER) to identify proteinuria and 24-hour urinary albumin excretion rate (AER) to identify albuminuria. These methods are the gold standards for the quantitative assessment of proteinuria (National Kidney Foundation, 2002). However, 24-hour urine collection may cause errors if patients miss or improperly collect some samples. Thus leading to underestimated amounts of protein. Albuminuria is defined as an AER of equal to or more than 300 mg/ 24 hour (KDIGO, 2012b). If any CAM can diminish proteinuria in patients with diabetes or glomerular diseases, it could slow the progression of diseases. In 2012, KDIGO proposed a new classification of CKD based on eGFR (stage 1-5 or G1-G5, see Table 3) and albuminuria (A1-A3) related to risk of cardiovascular mortality (Figure 1) (KDIGO, 2012a). A1,A2 and A3 is ACR < 30, 30-300, and > 300 mg/g, respectively. Table 2. The cutoff points of quantitative assessment of proteinuria Urine Protein Measurement

Cutoff Point of Proteinuria or Albuminuria

Urine protein-to-creatinine ratio, PCR

> 500 mg/g

Urine albumin-to-creatinine ratio, ACR

> 300 mg/g

Urine dipstick test

> 1+

24-hour urinary protein excretion rate, PER

> 500 mg/ 24 hour

24-hour urinary albumin excretion rate, AER

> 300 mg/ 24 hour

400

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Table 3. The classification of chronic kidney disease based on GFR Stage

Prognosis of CKD

GFR (ml/min/1.73m2)

1 (G1)

Normal or high

> 90

2 (G2)

Mild decrease

60-89

3a (G3a)

Mild to moderate decrease

45-59

3b (G3b)

Moderate to severe decrease

30-44

4 (G4)

Severe decrease

15-29

5 (G5)

Kidney failure

< 15

Figure 1. Cardiovascular mortality risk: a relationship between GFR and albuminuria

This figure shows a relationship between albuminuria and glomerular filtration rates (GFR). A higher amount of albuminuria with lower GFR (thus, more advanced stage of CKD), the greater the risk of cardiovascular mortality. Abbreviations: ACR = Urine Albumin-to-Creatinine Ratio, GFR = Glomerular Filtration Rate. Color; Green: low risk; Yellow: moderately increased risk; Orange: high risk; Red: very high risk. Some Chinese herbal medicines have been used as an adjunctive therapy to conventional medicine for kidney transplantation. Their target is to prevent acute renal allograft rejection and chronic renal allograft injury. An increase in serum creatinine and proteinuria are clinical manifestations of acute rejection and chronic allograft injury when other causes of graft dysfunction have been excluded. For kidney transplant recipients, the KDIGO Clinical Practice Guideline (2009) recommended biopsy to diagnose acute rejection and chronic allograft injury (Miller et al., 2007). The Banff classification is a standard international classification for the assessment of renal allograft biopsies and has been used in identifying these problems since the 1990s. The Banff 07 classification is the latest version (Bhowmik et al., 2010). Evaluating the efficacy of CAM for kidney transplantation should follow the Banff standard guidelines.

401

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Dissolution of urolithiasis is another expected outcome from using several herbal medicines. As known, urinalysis is a basic test to monitor the outcome of treatment of urolithiasis. Microscopic urinalysis can detect crystals in urine and measure the size of the stones. Calcium oxalate crystals are the most common stones in kidneys. The efficacy of an herbal medicine for this disease can be judged by measuring the size of the stones. If the medicine is effective it would reduce the size of the stones or give stone relief.

Humanistic Outcomes Chronic kidney disease and dialysis therapy affect patients’ quality of life (QoL). Such conditions cause symptoms related to poor QoL such as fatigue, stress, anxiety, depression, insomnia, lack of mobility, and sexual dysfunction. Additionally, patients with urolithiasis suffer from pain, which is another condition related to decreased QoL (Penniston et al., 2013). These symptoms influence, most often negatively, physical, psychological and social functioning, which are related to the patients’ QoL. Patients receiving dialysis therapy are not required to evaluate their kidney function as their kidneys have reached end-stage renal disease. The outcomes of their treatment are ones that alleviate the symptoms of CKD complications and improve QoL. Although some CAM may not directly cause physiological changes, they may alleviate such symptoms or improve the QoL. For example, herbal medicine, acupuncture, massage, and mind-body therapies have yielded positive evidence in the treatment of kidney diseases and associated complications. It is important to keep in mind that not only CAM influences QoL, other factors, such as standard conventional therapies, social relationships and financial concerns, are also associated with this outcome. The World Health Organization (WHO) offers a broad definition of QoL which includes physical, mental and social well-being of an individual (The WHOQoL Group, 1995). Health-related quality of life (HRQoL) is the most common humanistic outcome to quality of life. Unruh and Hess (2007) proposed a more specific HRQoL for patients with CKD that consists of the following four domains: 1. 2. 3. 4.

Physical function, e.g., physical activity, fatigue, etc. Psychological status, e.g., stress, anxiety, depression, cognitive function, etc. Social status, e.g., family relationships, relationship stability, etc. Global QoL, e.g., perceived health, daily functioning, happiness, etc.

Therefore, measurement of HRQoL in patients with kidney diseases should include these domains. In addition, Verhoef et al. (2006) proposed six domains to assess health-related outcomes from using CAM: physical, psychological, social, spiritual and holistic outcomes, quality of life, and individualised outcomes. The In-CAM database has gathered questionnaires to measure outcomes (IN-CAM, 2014). These tools have been designed for patient-centred, subjective outcome measurement. Choosing an appropriate questionnaire to measure an outcome of CAM should regard whether the questionnaire is well tested, acceptable and relevant to patients, and sensitive to change. There are two main types of QoL questionnaires: generic or disease-specific. The generic questionnaires measure HRQoL, developed from the WHO definition in a wide range of patient populations such as patients with kidney diseases, asthma or cardiovascular diseases. The disease-specific questionnaires evaluate HRQoL in a specific disease condition, such as CKD. An ideal HRQoL questionnaire should be simple, short and easy to comprehend, as it is difficult for many patients to complete a long questionnaire.

402

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Commonly Used HRQoL Questionnaires in Patients With Kidney Diseases 1. Generic Questionnaires: Table 4 shows the most common generic questionnaires, the domains they measure, the populations with kidney diseases assessed, and the availability of the questionnaires in other languages. The domains they measure are associated with the concept of QoL measurement as described above. a. The Short Form 36 Health Survey (SF-36): Is the most common generic questionnaire to measure HRQoL and has been translated and validated in more than 35 countries. This questionnaire is frequently used for patients with CKD receiving dialysis or urolithiasis (Bensalah et al., 2008; Butt et al., 2008; Merkus et al., 1997). It is also commonly used in evaluating the QoL in CAM users (Verhoef et al., 2006). b. The EuroQoL Five-Dimensional Questionnaire (EQ-5D): Is easily completed by respondents, can be used for evaluating economic outcomes, and is available in 170 different languages (Yang et al., 2015). This questionnaire is widely used in dialysis or kidney transplant patients (Sakthong et al., 2012; Wyld et al., 2012).

Table 4. Most common generic questionnaires about quality of life Questionnaire Abbreviation, Number of Items (References)

Measurement of QoL Domains

Kidney Patient Populations

Languages

SF-36, 36 items (Ware et al., 1992)

Physical functioning, role physical, bodily pain, general health perceptions, vitality, social functioning, role emotional, and mental health

    CKD, dialysis, kidney transplantation, urolithiasis

    English, Arabic, Chinese, Danish, Dutch, Finnish, French, German, Hebrew, Italian, Japanese, Norwegian, Russian, Spanish, Swedish, Turkish, Vietnamese, Welsh, etc.

EQ-5D, 5 items (Rabin et al., 2001)

Mobility, self-care, usual activities, pain/discomfort, and anxiety/depression

    Dialysis, kidney transplantation

    English, Danish, Dutch, Finnish French, German, Japanese, Spanish, Thai, etc.

WHOQoL-BREF, 26 items (Skevington et al., 2004)

Physical health, psychological status, social relationships and environment

    Haemodialysis, kidney transplantation

     English, Chinese, Dutch, French, German, Hebrew, Japanese, Persian, Russian, Thai, etc.

NHP, 45 items (Wiklund, 1990)

6 domains of health and 7 domains of daily living

    Haemodialysis, kidney transplantation

     English, Danish, Dutch, French, German, Greek, Russian, Spanish, Swedish, Turkish

SIP, 136 items (Bergner et al., 1981)

Sleep and rest, emotional behaviour, body care and movement, home management, mobility, social interaction, ambulation, alertness behaviour, communication, work, eating, and recreation & pastimes

    Dialysis, kidney transplantation

     English, Arabic, Chinese, Danish, Dutch, Finnish, French, German, Italian, Norwegian, Portuguese, Romanian, Russian, Spanish, Swedish, Tamil, Thai

The Dartmouth COOP Charts, 7 items (Kempen et al., 1997)

Physical fitness, feelings, daily activities, social activities, change in health status, current overall health perceptions, and bodily pain

    Dialysis

    English, Dutch, Finnish, French, German, Hebrew, Japanese, Moroccan, Spanish, Turkish

403

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

c. The World Health Organization Quality of Life Brief (WHOQoL-BREF): Is a 26-item short version of the WHOQoL and is available in 19 different languages. It has been used in patients receiving haemodialysis or kidney transplants (Sathvik et al., 2008). d. The Nottingham Health Profile (NHP): Coons et al. (2000) evaluated this questionnaire and found that the NHP is simple and evaluates QoL in general, rather than from a health professionals’ perspective. Part one of the NHP consists of six health domains (38 items): physical mobility, pain, sleep, energy, social isolation, and emotion. Part two is comprised of seven domains of daily life: paid employment, home duties, social life, personal relationships, sex life, hobbies and interests, and holidays. This questionnaire has been translated into 24 languages. The NHP has been used in assessing the QoL in Filipinos receiving haemodialysis and Turkish kidney transplant patients (Chuku et al., 2010; Ogutmen et al., 2006). e. The Sickness Impact Profile (SIP): Is used for evaluating sickness in relation to behaviour dysfunction. This tool is to assess and discriminate the likelihood of physical functioning between patients receiving dialysis or kidney transplantations (Hart et al., 1987). The SIP consists of 136 items and therefore creates a respondent burden, whilst the SIP 68 is a short version. The SIP 136 takes 30 minutes to complete and the SIP 68 takes 15-20 minutes (Busija et al., 2011). f. The Dartmouth Cooperative Functional Assessment (COOP) Charts: Are appropriate for practitioners to assess patients’ QoL on a daily basis. This instrument is simple and suitable for people who have difficulty reading (Kempen et al., 1997). This tool can be used with dialysis and transplant patients. All of these questionnaires are likely to be completed within 15 minutes, except the SIP. 2. Disease-Specific Questionnaires: There are several standardised questionnaires to evaluate HRQoL in patients with kidney diseases (Table 5). The questionnaires are appropriate for end-stage renal disease (ESRD), kidney transplantation, or urolithiasis. a. Questionnaires for ESRD: The four questionnaires to assess the HRQoL in patients receiving dialysis are (1) the Kidney Disease Quality of Life 36 questionnaire (KDQOL-36); (2) the Kidney Disease Quality of Life Short Form (KDQOL-SF); (3) the CHOICE Health Experience Questionnaire (CHEQ), and (4) the Kidney Disease Questionnaire (KDQ). The KDQOL-36 and the KDQOL-SF questionnaires have been designed for ESRD. The KDQOL-36 has been translated into 24 different languages. These tools are commonly used in patients with CKD or who are receiving dialysis. The KDQOL-36 has been developed from the SF-36, but has added disease-specific items relating to the impact of disease-specific dietary restrictions and their attitudes towards the illness. The KDQOL-36 may create respondent burden due to it taking 30 minutes to complete, whilst the KDQOL-SF takes approximately 16 minutes to complete (Rettig et al., 1997). The KDQOL-SF questionnaire covers the domains of physical and mental health, and the six kidney disease issues of cognitive function, symptoms, and the effect of the kidney disease, sexual function, sleep, and patient satisfaction (Moreiras-Plaza et al., 2011). The KDQOL-SF has also been tested for validity and reliability, and used with kidney transplant recipients (Barotfi et al., 2006). The CHOICE Health Experience Questionnaire (CHEQ) has been designed for ESRD and complements the SF-36. It has an additional eight generic domains and five ESRD-specific domains over and above the SF-36. The eight additional domains are: cognitive and sexual functioning, sleep, work, recreation, travel, finances, and general quality of life. The five 404

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Table 5. Most common disease-specific questionnaires for measuring quality of life in patients with kidney diseases Questionnaire Abbreviation, Number of Items (References)

Dimensions

Patient Population

Languages

KDQOL-36, 36 items (Hays et al., 1994)

Physical and mental health, burden of kidney disease, symptoms, effects of kidney disease

    Dialysis

    English, Arabic, Chinese, French, German, Spanish, etc.

KDQOL-SF, 79 items (Hays et al., 1997)

Symptoms, burden of kidney disease, effects of kidney disease, work status, cognitive function, quality of social interaction, sexual function, sleep, social support, dialysis staff encouragement, patient satisfaction

    Dialysis

    English, Arabic, Hungarian, Polish, Turkish, Moroccan, Spanish

CHEQ, 83 items (Wu et al., 2001)

8 generic domains in the SF-36 combined with 8 additional generic domains and 5 ESRD-specific domains

    Dialysis

    English, Thai

KDQ, 26 items (Laupacis et al., 1992)

Physical symptoms, fatigue, depression, relationships, frustration

    Haemodialysis

    English

KTQ, 25 items (Laupacis et al., 1993)

Physical symptoms, fatigue, uncertainty/fear, appearance, and emotional status

    Kidney transplantation

    English, Persian, Spanish

ESRD-SCL, 43 items (Franke et al., 1999)

Limitations in the physical and cognitive capacity, cardiac and renal dysfunction, side effects of corticosteroids, increased hair growth, transplant-associated psychological disorders

    Kidney transplantation

    English, German, Norwegian, Spanish, Turkish

WSQ 28 item (Penniston et al., 2013)

Energy and fatigue, sleep, work and family, nutrition and pharmacological therapies, physical symptoms, concerns related to intimacy and travel, general emotional wellbeing

    Urolithiasis

    English

ESRD-specific domains are: diet, freedom, body image, dialysis access (catheters and/or vascular), and symptoms (Wu et al., 2001). The Kidney Disease Questionnaire (KDQ) has been constructed for patients receiving haemodialysis (Laupacis et al., 1992). Unlike other specific questionnaires, the KDQ only takes 10-15 minutes to complete (Edgell et al., 1996). However, this questionnaire does not evaluate a respondent’s overall health status. b. The two HRQoL questionnaires for kidney transplant recipients are the Kidney Transplant Questionnaire (KTQ) (Chisholm-Burns et al., 2011), and the End-Stage Renal Disease Symptom Checklist-Transplantation Module (ESRD-SCL) that is focused on transplantation-specific symptoms, psychological distress, and the side effects of immunosuppressive therapy (Franke et al., 1999). c. The Wisconsin Stone QoL instrument (WSQ) was developed for patients with urolithiasis in 2013 (Penniston et al., 2013). However, this questionnaire is still in the process of being tested for its test-retest reliability, concurrent validity, and construct validity (Raja et al., 2014). Three classic administration modes for such questionnaires are self-administered, face-to-face or over the telephone. Each method has its own advantages and disadvantages. Some advantages of selfadministered surveys are that they are less expensive, more convenient, and provides more privacy

405

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

than the interviews. Their disadvantages are poor response rates, and poor completion rates. Interviews provide a higher response rate than postal questionnaires and are suitable for non-readers. However, this method of data gathering is expensive in both time and money. There is also the possibility that an interviewer may bias the findings, i.e. the Hawthorne Effect. However, Unruh, et al. (2003) suggests that an interview-administered questionnaire is suitable for dialysis patients. Their study shows that patients who completed a HRQoL by themselves, had inaccurate HRQoL as dialysis patients frequently have vision problems and limited arm ranges during dialysis. Regarding the time-period to measure the HRQoL, this outcome can be assessed at one point, before and after interventions, or over a period of time, such as 1-2 years. Advantages of the generic questionnaires, particularly the SF-36, are that they are able to assess the HRQoL in patients with various diseases, including kidney diseases. The findings from such tools can be compared with general populations or other patient groups. These questionnaires also take a shorter time to complete compared with the specific questionnaires, except the KDQ. However, they are sometimes unable to discriminate the HRQoL between patients who are receiving an intervention, and a placebo group; especially if the intervention improves some specific symptoms in patients with ESRD or kidney transplant recipients (Edgell et al., 1996). The disease-specific questionnaires are more responsive to detecting the treatment effects in the HRQoL related to a specific disease state. The authors of this chapter suggest that clinicians and researchers could use both generic and specific questionnaires to complement each other; the generic questionnaires can assess the HRQoL related to daily life, which is lacking in specific questionnaires. Therefore, researchers should choose the questionnaire and the method of administration that is most appropriate for their measurement objectives and their population. All of the questionnaires need permission from copyright holders before using them. Some may charge a license fee depending on whether it’s for commercial or non-commercial usage, such as the SF-36, the NHP, the SIP136, the Dartmouth COOP Charts, or the KDQOL-36. Several HRQoL tools provide a score of QoL, e.g. SF-36, KDQOL-36, etc., and it is a challenge to interpret the HRQoL scores to determine meaningful clinical practice and how to link HRQoL scores to a clinically relevant effect size. Recently, two methods have been proposed to identify a cutoff point of clinical significance in chronic diseases: anchor-based methods, and distribution-based methods (Revicki et al., 2008). Anchor-based methods estimate the minimal clinically important difference (MCID). The variety of MCID depends on the type of disease, the HRQoL questionnaire used, and the populations. The literature suggests that MCID for each disease is estimated by findings from clinical trials or systematic reviews. This existing evidence provides a target significant difference in HRQoL scores between treatment and control groups in patients with same disease. This difference should be associated with clinical significance. More details of the methods of estimating MCID are explained in a review of recommended methods for determining responsiveness (Revicki et al., 2008), and a paper (Hedayat et al., 2015). Unfortunately there is a lack of existing evidence to estimate MCID in patients with kidney diseases. Revicki, et al. (2008) suggests the use of a second method to determine clinically relevant effect sizes in HRQoL, i.e., distribution-based. This is the determination of clinically relevant effect sizes based on a distribution database of HRQoL scores in each disease. For instance, half a standard deviation of the mean HRQoL score in the population can be a cutoff point of clinical significance (Revicki et al., 2008). One major limitation of this method is that the determination of this cutoff point is mainly based on statistics and, as a result, may not relate to clinically relevant effect sizes. In addition, many factors may influence the HRQoL rather than the intervention, e.g. economic status, access to

406

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

the basic needs of life, the national health system, availability of social support, etc. Lack of access to a health system is likely to cause a worsening in an individual’s HRQoL, whilst having good social support seems to improve this outcome (Kang et al., 2015; Zyoud et al., 2016). Therefore, the interpretation of the HRQoL should include not only estimating a cutoff point of clinically relevant effect sizes in each kidney disease, but also other potential confounding factors related to the HRQoL scores.

Measure of Patients’ Symptoms and Patient Satisfaction Many generic and disease-specific questionnaires evaluate patients’ symptoms or physical functioning; for example, SF-36, KDQoL, CHEQ, KDQ, and KTQ. These outcomes are subjective, so the data may be less accurate than objective, clinical outcomes. Validated instruments provide a more accurate measurement. The questionnaires often use a 4 or 5 point Likert scale, whilst others use Yes/No responses, visual analogue scales or 10-point scales to assess outcomes. 3. Questionnaires to Evaluate Patients’ Symptoms in Kidney Diseases: Assessing symptoms in critically ill patients with ESRD can be adopted from symptom-specific questionnaires for patients with cancer, such as the Memorial Symptom Assessment Scale (short form), and the McGill Quality of Life questionnaire, due to such diseases having similar heath status, e.g. life-threatening (Murtagh et al., 2007). This section will focus on seven symptom-specific questionnaires validated for use in patients with CKD, receiving dialysis, or kidney transplants. Most of the questionnaires have been designed to assess the severity of symptoms in dialysis patients. Seven relevant symptom-specific questionnaires are: (1) the Palliative Care Outcome Scale-Symptoms modified for renal patients (POS-S renal), (2) the Human Activity Profile (HAP), (3) the Modified Edmonton Symptom Assessment System (ESAS), (4) the Dialysis Symptom Index (DSI), (5) the 100 Category Check List, (6) the Short-Version Check List, and (7) the Physical Symptom Distress Scale (PSDS) (Table 6). The ideal questionnaire to estimate patients’ symptoms should target symptoms that have happened within the last 7 days in order to reduce recall bias, as well as being able to measure multiple symptoms (Flythe et al., 2015). a. The Palliative Care Outcome Scale-Symptoms modified for renal patients (POS-S renal): Evaluates 17 symptoms in patients with advanced CKD or end-stage renal disease (Murphy et al., 2009). Recently, the Integrated POS-Renal (IPOS-Renal) has been developed through the integration of the IPOS and POS-S Renal instruments in order to provide a short questionnaire to assess symptoms in ESRD patients (11 questions). This questionnaire is designed for clinicians but still needs to be fully validated (Palliative care Outcome Scale, 2012). b. The Human Activity Profile (HAP): Has been validated in haemodialysis patients to measure physical activity and functioning (Johansen et al., 2001). This questionnaire is also used for patients with CKD and with kidney transplant recipients (Johansen et al., 2001; RobinsonCohen et al., 2013). A total of 94 specific activities in the HAP relate to the energy expenditure required to perform a task such as getting in and out of chairs or bed, taking a bath, walking 30 yards, or climbing 6 steps. There are three options for response: (1) still doing this activity, (2) have stopped doing this activity, and (3) never did this activity.

407

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Table 6. Symptoms-specific questionnaires for CKD, ESRD, and kidney transplantation Questionnaire Abbreviation, Number of Items (References)

Dimension

Patient Population

Recall

Language

POS-S renal, 17 items (Murphy et al., 2009)

Physical symptoms, including itchy and restless legs

  Advanced CKD, ESRD

    3 days

    English, Portuguese

HAP, 94 items (Johansen et al., 2001)

Energy expenditure required to perform the task

  Haemodialysis, CKD, kidney transplantation

    7 days

    English, German

ESAS, 10 items (Davison et al., 2006)

Physical and psychological symptom distress

  Dialysis

    Present

    English

DSI, 30 items (Weisbord et al., 2004)

Physical and emotional symptoms

  Haemodialysis

    7 days

    English

100 Category Check List, 100 items (Tsutsui et al., 2014)

Body functions and structures, activities and participation, environmental factors

  Haemodialysis

    Unknown

    Japanese

Short-Version Check List, 31 items (Tsutsui et al., 2014)

Body functions and structures, activities and participation, environmental factors

  Haemodialysis

    Unknown

    Japanese

PSDS 16 item (Chiou, 1998)

Fluid and electrolyte imbalance and disturbance in neuromuscular function

  Haemodialysis

    7 days

    English, Chinese

c. The Modified Edmonton Symptom Assessment System (ESAS): Has been validated in both haemodialysis, and peritoneal dialysis patients. This tool assesses 10 symptoms using a visual analogue scale (0-10): pain, tiredness, well-being, drowsiness, shortness of breath, anxiety, depression, appetite, nausea, and itch (Davison et al., 2006). It is simple and suitable for clinical use. d. The Dialysis Symptom Index (DSI): Has been tested for validity and reliability in patients undergoing haemodialysis, and measures a total of 30 symptoms (Weisbord et al., 2004). Examples of symptoms in the questionnaire are constipation, appetite, muscle cramps, swelling in legs, breathlessness, numbness, tiredness, pain, itch, worry, insomnia, mood, and libido. e. The 100 Category Check List: Has been tested for validity and reliability in Japan (Tsutsui et al., 2014). Due to a high number of items (100), the Short Version Check List consisting of 31 categories has been developed for clinical use (Tsutsui et al., 2014). Regarding items in the short version, components are body function, and structure, activities and participation, and environmental. However, these questionnaires need to be translated and validated for other languages in other populations. f. The Physical Symptom Distress Scale (PSDS): Has been developed to evaluate patients’ symptoms of distress in haemodialysis (Chiou, 1998). This 16-item questionnaire is comprised of two domains: (1) fluid and electrolyte imbalance (e.g. numbness, impaired visual ability, swelling in feet, itching, fatigue, etc.), and (2) disturbance in neuromuscular function (e.g. dizziness, headache, muscle cramps, difficulty sleeping, shortness of breath, etc.).

408

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Moreover, questionnaires have been designed to measure a specific symptom, e.g., anaemia or side effects of immunosuppressants, in patients with dialysis or kidney transplants, which are not included in the prior questionnaires. The National Kidney Dialysis and Kidney Transplantation Study Symptom Checklist (NKDKTS) has been validated to assess symptoms of anaemia in dialysis patients (Spiegel et al., 2009). Meanwhile, the Transplant Symptom Occurrence and Distress Scale evaluates symptoms of the side effects of immunosuppressants in kidney transplant recipients (Dobbels et al., 2008). However, these tools do not seem to be suitable for evaluating the severity of multiple symptoms.

Measurement of Symptom Outcomes From Using CAM The questionnaires measuring the improvement of symptoms in patients with kidney diseases may be applied to evaluating CAM. However, a limitation of these questionnaires is a lack of validity in CAM research, so the questionnaires should be used with caution. Choosing a questionnaire to assess symptoms in CAM users depends on the target symptoms related to the CAM, and the population. When practitioners and researchers aim to measure a specific symptom, such as depression, they should use an available valid symptom-focused questionnaire. The Beck Depression Inventory and the Brief Pain Inventory are frequently used in evaluating depression and pain in dialysis patients (Murtagh et al., 2007). There is a validated generic questionnaire to assess the degree of any symptoms related to CAM use, i.e. the ‘Measure Yourself Medical Outcome Profile’ (MYMOP). It is used in measuring any symptom change, particularly in acute symptoms, over the period of time, and allows an individual to choose the most problematic symptom (Paterson, 1996). This questionnaire can measure an effect of a wide variety of CAMs as it is not designed to measure a specific symptom. It is simple and appropriate for CAM practitioners to use during a consultation. This tool covers the measurement of symptoms, activities, and wellbeing. The MYMOP 2 has been developed, based on limitations of the original MYMOP and added medication history for a chosen symptom (Paterson et al., 2000). The effects of several CAMs have been assessed by the MYMOP, such as acupuncture, massage therapy, and chiropractic (Hull et al., 2006; Polus et al., 2011; Wakefield, 2014). This questionnaire has also been translated from English into Chinese and validated in the Chinese population (Chung et al., 2010). Therefore, the MYMOP is recommended to assess alleviated symptoms from using CAM, although it needs to be tested for validity and reliability when used in patients with kidney diseases. A limitation of this tool is that it collects subjective data, so practitioners should interpret the findings with caution.

Questionnaires to Evaluate Patient Satisfaction There is a lack of validated questionnaires to assess patient satisfaction in CKD patients and kidney transplant recipients. Few questionnaires assessing satisfaction in dialysis patients have been developed (Gu et al., 2015; Kirchgessner et al., 2006; RAND Health, 2015; Rubin et al., 1997; Wasserfallen et al., 2006). They measure patient satisfaction from dialysis therapy and care, e.g. doctor and nurse services, physical environment at a dialysis clinic, etc. Health care providers use the questionnaires to improve their services. These tools therefore, need to be modified in order to assess specific CAMs, and need to be validated. However, some researchers may use their own questionnaires to evaluate patient satisfaction in CAM research (Barbadoro et al., 2011). Using standardised questionnaires to assess symptoms and patient satisfaction in CAM research provides more valid information rather than just reports of practitioner or patients’ experience.

409

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

ADVERSE EFFECTS OF CAM Potential renal side effects of herbal medicines and dietary supplements (HDS) are acute kidney injuries (AKI), electrolyte imbalance, or kidney stones. AKI is a factor caused by the progression of CKD, followed by end-stage renal disease, and death. Pre-existing CKD is, on the other hand, a potential risk to developing AKI. There are many case reports on these adverse events related to herbal medicine worldwide (Luyckx, 2012). However, some CAM modalities are more complex and employ more than one CAM, such as using herbal medicine together with acupuncture, so it is difficult to identify which element caused any adverse effect. In addition, adulterants in unregistered herbal products may cause AKI, e.g. steroids and non-steroidal anti-inflammatory drugs, etc. Patients with CKD or kidney transplant recipients, who use herbal medicines and/or dietary supplements often do so together with conventional medicine. As a result, HDS may interact with conventional medicines, and either decrease or increase the effect of them. Consequently, patients may experience ineffectiveness or toxicity from the conventional medicine. This issue will be discussed in Chapter 8. Not only can the health products cause such adverse events, but also their indirect effect may lead to worsening illnesses; for instance, through poor conventional medication adherence, and delaying diagnosis or treatment amongst CAM users.

Acute Kidney Injuries, Electrolyte Imbalance, and Kidney Stones The current universally accepted definition of AKI as proposed by the Acute Kidney Injury Network (AKIN) in 2007 (Table 7) (Lopes et al., 2013). With this definition, two serum creatinine evaluations within 48 hours of symptom onset are necessary for the diagnosis of AKI; dialysis should be considered for any patient with AKI stage 3 (failure stage).

Evaluation of Nephropathy Related to Herbal and Dietary Supplements To assess HDS that may induce AKI, any herbal medicines or dietary supplements resulting in AKI would be identified as nephrotoxic agents, if there are no other causes related to AKI, such as dehydration or conventional medicines, i.e. non-steroidal anti-inflammatory drugs (NSAIDs) (Table 8) (Choudhury et al., 2006; Lameire et al., 2013). The World Health Organisation’s Uppsala Monitoring Center causality assessment is a validated general questionnaire to evaluate adverse effects of medication. Due to a lack of tools assessing causality of herbal medicine related to nephropathy, the WHO causality assessment is frequently used (Table 9) (Tangkiatkumjai et al., 2015; The Uppsala Monitoring Centre, 2015). Table 7. The classification of severity of acute kidney injury Stage

Serum Creatinine (SCR)

Urine Output

1 (Risk stage)

1.5 times baseline OR increase in Scr > 0.3 mg/dl

< 0.5 ml/kg/h for 6 hours

2 (Injury stage)

2.0 times baseline

< 0.5 ml/kg/h for > 12 hours

3 (Failure stage)

410

3.0 times baseline OR

< 0.3 ml/kg/h for 24 hours OR

Increase in Scr > 4.0 mg/dl

Anuria for 12 hours

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Table 8. Common causes of acute kidney injuries Causes Bleeding, dehydration

Region Worldwide

Sepsis, shock Nephrotoxic medicines ACEIs/ ARBs Aminoglycosides Amphotericin B Cyclosporine, tacrolimus Indinavir NSAIDs COX-2 inhibitors Radiocontrast media Diarrhoea

Tropical countries

Snake bite Tropical infectious diseases Traditional medicines ACEIs = Angiotensin-converting enzyme inhibitors ARBs = Angiotensin II receptor antagonists NSAIDs = Non-steroidal anti-inflammatory drugs COX-2 inhibitors = Cyclooxygenase-2 inhibitors

Table 9. Causality assessment of suspected adverse effects Category

Assessment Criteria

Certain

• Event or laboratory test abnormality, with plausible time relationship to suspected products intake • Cannot be explained by disease or other drugs • Response to withdrawal plausible (pharmacologically, pathologically) • Event definitive pharmacologically or phenomenologically (i.e. an objective and specific medical disorder or a recognised pharmacological phenomenon) • Rechallenge satisfactory, if necessary

Probable /likely

• Event or laboratory test abnormality, with reasonable time relationship to suspected products intake • Unlikely to be attributed to disease or other drugs • Response to withdrawal clinically reasonable • Rechallenge not required

Possible

• Event or laboratory test abnormality, with reasonable time relationship to suspected products intake • Could also be explained by disease or other drugs • Information on suspected product withdrawal may be lacking or unclear

Unlikely

• Event or laboratory test abnormality, with a time to suspected products that makes a relationship improbable (but not impossible) • Disease or other drugs provide plausible explanations

For instance, if an herbal medicine which may be associated with AKI is assessed by these criteria and falls into the category of ‘certain’, this means that it is definitely associated with AKI. The World Health Organization’s Uppsala Monitoring Center causality assessment can also be used to evaluate any adverse effects, such as electrolyte imbalance and kidney stones, as it is designed based on a general concept of 411

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

evaluating adverse effects. Its limitations are that it does not use quantitative causality assessment, so assessors need to judge the likelihood of the adverse effect being related to the herbal medicine themselves. The modified Naranjo algorithm has been proposed as a way to evaluate causal relationships of adverse events with HDS (Table 10) (Ide et al., 2015). The main problem with the Naranjo algorithm is that there is a lack of evidence to confirm that HDS is related to adverse events. The modified Naranjo algorithm responded to this by requiring information from the label or package insert of the HDS. Ide et al. also used dose-dependence on the severity of an adverse event. There is a rating scale for the total: (1) highly probable is defined as the total score > 9; (2) 5-8 are defined as probable; (3) scores of 3-4 are defined as highly possible; (4) 1-2 score(s) are defined as possible; and (5) < 0 is defined as unlikely. The modified algorithm is therefore practical. The limitation of this tool is that some HDS may cause AKI associated with hypersensitivity, so question no. 6 (Table 10) is not applicable. The pathogenesis of AKI is due to the involvement of various cellular responses including leukocyte infiltration and humoral responses with proinflammatory cytokines, which induces apoptotic activities, abnormalities in immune modulators, and growth factors in the repair response (Devarajan, 2006; Kellum et al., 2011; Sanoff et al., 2011). The knowledge of the pathogenetic mechanism has founded a basis of current therapeutic interventions. There are three main rationales for AKI therapies. First, increasing oxygen delivery to the injured renal tissues by improving renal blood flow or decreasing oxygen demand in the repairing of renal tubular tissues. Second, reducing inflammatory processes via the inhibition or elimination of proinflamatory cytokines, free radical oxygen species, apoptotic activities, expressions of adhesion molecules, or leukocyte function. Third, promoting tissue repair by enhancing renal tubular regeneration via growth factors or mesenchymal stem cell therapy. However, most clinical trials have failed to establish any significant specific treatments (Conger, 1995; Jo et al., 2007; Ronco et al., 2003) as many have focused on eliminating inflammatory responses alone, believing that inflammation is maladaptive. To definitively identify pathophysiological effects of AKI, a kidney biopsy is required which is suited for research rather than routine practice as it is costly and needs specialists to operate and interpret the results. Several case reports of AKI being caused by health products have not had a kidney biopsy, so there is lack of evidence on this issue. Table 10. The modified Naranjo algorithm adapted from Ide et al. (2015) Question

Yes

No

Do Not Know

1. Is there any notification about the adverse event on the label or package insert of the HDS?

+1

0

0

2. Did the adverse event appear after the suspected HDS intake?

+2

-1

0

3. Did the adverse event improve when the suspected HDS was discontinued?

+2

0

0

4. Did the adverse event reappear when the HDS was retaken?

+3

-1

0

5. Are there any alternative causes (other than the suspected HDS) that could on their own have caused the event?

-1

+2

0

6. Was the event more severe when the dose was increased or less severe when the dose was decreased?

+1

0

0

7. Did the consumer have a similar event to the same or a similar HDS in any previous exposure?

+1

0

0

8. Was the adverse event confirmed by any objective evidence?

+2

0

0

412

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Assessment of Herbal and Dietary Supplements Associated With Electrolyte Imbalance and Kidney Stones Several herbal medicines or dietary supplements can cause electrolyte imbalance, and urolithiasis. Excessive intake of vitamin C or star fruits, increase urinary oxalate excretion thereby increasing the risk of obstructive nephropathy from calcium oxalate crystals, which are identified by urinalysis (Abeysekera et al., 2015; Ferraro et al., 2015). Nonetheless, ultrasonography or computed tomography (CT) is sometimes required to diagnose obstruction from urolithiasis. In the advanced CKD patient (stage 3 CKD ; eGFR < 60 ml/min/1.73m2), taking these herbal medicines or dietary supplements can cause a faster decline in GFR (called AKI on CKD) and can eventually progress to end stage renal disease (stage 5 CKD) (Palevsky et al., 2013). Electrolyte imbalances, particularly hyperkalemia (serum potassium > 5.5 mmoL/L) (Hollander-Rodriquez et al., 2006), and hyperphosphatemia (serum phosphate > 4.5 mg/ dL) (Moretti et al., 2008) have been associated with herbal medicine usage. Individuals with advanced CKD, especially stage 5, are already susceptible to hyperkalemia and hyperphosphatemia and therefore the accumulative use of HDS may potentially lead to life-threatening conditions such as arrhythmias, cardiac arrest or coronary artery disease. Due to limited evidence from clinical studies, animal studies are a further information source relating to the issue of safety. In general, herbal medicines should be tested for organ-targeted toxicity, including kidneys, in animal models. Therefore, it is suggested that practitioners and consumers should avoid usage without clear evidence of benefits. In summary, health care providers should regularly monitor serum creatinine, levels of potassium and phosphate, and urinalysis in patients with renal insufficiency in order to prevent nephropathy from using herbal medicines or dietary supplements. Due to a lack of evidence on renal adverse effects of these products, practitioners who discover products related to such effects should report them in order to build up such evidence.

Indirect Risks From CAM Use Many studies of patients with CKD and hypertension report that CAM users are less likely to adhere to their conventional medications than non-users (Gohar et al., 2008; Krousel-Wood et al., 2010; Tangkiatkumjai et al., 2013). Medication non-adherence causes uncontrolled blood pressure in the population and may result in worsening kidney function. Reasons for CAM users having poor medication adherence may involve having negative attitudes towards conventional medicine, such as concern about their potential adverse effects. Health practitioners should acknowledge this issue, identify CAM users who may have poor conventional medication adherence, and tackle the problem. There are many methods to detect this problem such as self-report, medication records at the pharmacy, pill counts, electronic monitoring systems, or monitoring of serum drug levels. The Morisky Scale is widely used in evaluating medication adherence in CAM users and routine practice due to the instrument being simple, convenient, and short. This questionnaire has been translated into more than 10 languages, including Arabic, Chinese, French, German, Korean, Norwegian, Persian, Spanish, Thai, and Turkish. A limitation of this self-report tool is the likelihood of overestimates of medication adherence because of recall, and social desirability bias. The 8-item Morisky Medication Adherence Scale® (MMAS-8-Item®) is the latest version of this validated questionnaire and has been used in patients with CKD. Permission for using it is required, and a license fee depends on the purpose of use.

413

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Another indirect risk from using CAM is that it may delay patients from being diagnosed and treated (Wardle et al., 2014). This is because patients may consult CAM practitioners about non-specific symptoms, i.e. anorexia, fatigue, swelling, weight loss and diarrhoea, which may be indicative of serious diseases, such as chronic kidney disease or cancer. Therefore, CAM practitioners should be aware of this problem and refer patients to a doctor when they have symptoms that could indicate serious illnesses. Additionally, some CAM users refuse to disclose their use to their doctor because of concerns about disapproval from their doctor. As a result, interactions between CAM and conventional medicines may not be recognised by health care providers, and patients may suffer from adverse effects or ineffectiveness of conventional medicines.

FUTURE RESEARCH DIRECTIONS A high number of the validated questionnaires measure the humanistic outcomes of conventional medicine, and some of these questionnaires have been employed by CAM researchers or practitioners. Meanwhile, there is the lack of questionnaires which assess nephropathy due to using herbal medicines. The World Health Organisation’s Uppsala Monitoring Center causality assessment is a general questionnaire to evaluate adverse effects from conventional medicines and is widely used. However, it needs a skillful assessor to evaluate adverse effects from using herbal medicines due to the questionnaire not including a quantitative causality assessment. To use this tool effectively requires knowledge about evaluating AKI, time to onset of AKI related to HDS, and other risk factors of AKI. The Naranjo algorithm is also a quantitative causality assessment model and is commonly used. Neither of these causality assessment instruments are disease-specific nor validated in patients who suffer from nephrotoxicity related to herbal medicines. Further research therefore needs to develop and validate a disease-specific tool to assess causality of nephropathy related to herbal medicine. The MYMOP has been widely used in measuring the improvement of any symptoms due to CAM, but it has not been tested in patients with kidney diseases. Therefore, the validity and reliability of this questionnaire in this population is required. There is also a lack of validated questionnaires to assess patient satisfaction with their lives related to CAM in these populations.

CONCLUSION This chapter proposes methods for evaluating the benefits and risks of using CAM in CKD, dialysis therapy, kidney transplantation or urolithiasis. The target outcomes of CAM in these diseases are slowing the progression of CKD, alleviating symptoms in patients receiving dialysis, and a decrease in renal allograft rejection. Serum creatinine and eGFR are the markers employed to assess kidney function and AKI from both CAM or conventional medicine. These parameters are appropriate for a short-term follow-up, such as 6-12 months. Meanwhile, ESRD could be a long-term outcome of an intervention but requires 3-5 years. There are several validated questionnaires to evaluate symptoms, particularly in patients receiving dialysis. The Human Activity Profile measures the energy expenditure required to perform tasks and has been used with CKD, haemodialysis, and kidney transplant patients. This questionnaire may be used in evaluating the improvement of symptoms due to CAM. The MYMOP is widely used in evaluating alleviation of symptoms due to using CAM. The clinical outcomes of kidney

414

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

transplantation and urolithiasis require a nephrologist to evaluate and interpret findings from renal biopsies, urinalysis or CT scans. Some CAMs may improve a person’s the health-related quality of life (HRQoL) rather than physiological changes, so validated questionnaires should be used in measuring this outcome. The SF-36 is frequently used in evaluating the HRQoL in CKD, dialysis therapy, kidney transplantation, urolithiasis, and CAM research. CAM could cause both direct, and indirect, risks to health in patients with kidney diseases. Regarding the direct risks caused by active ingredients or adulterants in health products, AKI, electrolyte imbalance, or urolithiasis are the most common nephrotoxicity resulting from using HDS. Due to the lack of a disease-specific tool to evaluate nephropathy due to these products, the World Health Organisation’s Uppsala Monitoring Center causality assessment, and the modified Naranjo algorithm have been proposed for evaluating causal relationships of nephropathy related to CAM and HDS, respectively. The potential indirect risks to the health of CAM users are poor adherence to conventional medicine, and a delay in diagnosis or treatment of a kidney disease. The next chapter will explain how to search, appraise, and make a clinical decisions based on robust evidence.

REFERENCES Abeysekera, R. A., Wijetunge, S., Nanayakkara, N., Wazil, A. W., Ratnatunga, N. V., Jayalath, T., & Medagama, A. (2015). Star fruit toxicity: a cause of both acute kidney injury and chronic kidney disease: a report of two cases. BMC Research Notes, 8(1), 796. doi:10.118613104-015-1640-8 PMID:26680759 Badal, S. S., & Danesh, F. R. (2015). Diabetic nephropathy: Emerging biomarkers for risk assessment. Diabetes, 64(9), 3063–3065. doi:10.2337/db15-0738 PMID:26294427 Barbadoro, P., Chiatti, C., D’Errico, M. M., Minelli, A., Pennacchietti, L., Ponzio, E., & Prospero, E. (2011). Complementary and alternative medicine (CAM) among adults in Italy: Use and related satisfaction. European Journal of Internal Medicine, 3, e325–e332. Barotfi, S., Molnar, M. Z., Almasi, C., Kovacs, A. Z., Remport, A., Szeifert, L., ... Mucsi, I. (2006). Validation of the kidney disease quality of life-short form questionnaire in kidney transplant patients. Journal of Psychosomatic Research, 60(5), 495–504. doi:10.1016/j.jpsychores.2005.09.009 PMID:16650590 Bellomo, R., Ronco, C., Kellum, J. A., Mehta, R. L., & Palevsky, P. & Acute Dialysis Quality Initiative Workshop (2004). Acute renal failure - definition, outcome measures, animal models, fluid therapy and information technology needs: The Second International Consensus Conference of the Acute Dialysis Quality Initiative (ADQI) Group. Crit Care, 8(4), R204-212. Bensalah, K., Tuncel, A., Gupta, A., Raman, J. D., Pearle, M. S., & Lotan, Y. (2008). Determinants of quality of life for patients with kidney stones. The Journal of Urology, 179(6), 2238–2243. doi:10.1016/j. juro.2008.01.116 PMID:18423704 Bergner, M., Bobbitt, R. A., Carter, W. B., & Gilson, B. S. (1981). The sickness impact profile: Development and final revision of a health status measure. Medical Care, 19(8), 787–805. doi:10.1097/00005650198108000-00001 PMID:7278416

415

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Bhowmik, D. M., Dinda, A. K., Mahanta, P., & Agarwal, S. K. (2010). The evolution of the Banff classification schema for diagnosing renal allograft rejection and its implications for clinicians. Indian J Nephrol, 20(1), 2–8. doi:10.4103/0971-4065.62086 PMID:20535263 Busija, L., Pausenberger, E., Haines, T. P., Haymes, S., Buchbinder, R., & Osborne, R. H. (2011). Adult measures of general health and health-related quality of life. Arthritis Care & Research (Hoboken), 63(S11), S383–S412. doi:10.1002/acr.20541 PMID:22588759 Butt, Z., Yount, S. E., Caicedo, J. C., Abecassis, M. M., & Cella, D. (2008). Quality of life assessment in renal transplant: Review and future directions. Clinical Transplantation, 22(3), 292–303. doi:10.1111/ j.1399-0012.2007.00784.x PMID:18482050 Chiou, C. P. (1998). Development and psychometric assessment of the Physical Symptom Distress Scale. Journal of Pain and Symptom Management, 16(2), 87–95. doi:10.1016/S0885-3924(98)00036-0 PMID:9737099 Chisholm-Burns, M. A., Erickson, S. R., Spivey, C. A., Gruessner, R. W. G., & Kaplan, B. (2011). Concurrent validity of kidney transplant questionnaire in US renal transplant recipients. Patient Prefer Adherence, 5, 517–522. doi:10.2147/PPA.S24261 PMID:22114465 Choudhury, D., & Ahmed, Z. (2006). Drug-associated renal dysfunction and injury. Nature Clinical Practice. Nephrology, 2(2), 80–91. doi:10.1038/ncpneph0076 PMID:16932399 Chuku, C. L., Valdez, J. R., & Ajonuma, L. C. (2010). Is Nottingham Health Profile a reliable tool to measure quality of life of Filipinos with chronic kidney diseases undergoing hemodialysis. East African Journal of Public Health, 7(4), 286–288. PMID:22066322 Chung, V. C. H., Wong, V. C. W., Lau, C. H., Hui, H., Lam, T. H., Zhong, L. X., ... Griffiths, S. M. (2010). Using Chinese version of MYMOP in Chinese medicine evaluation: Validity, responsiveness and minimally important change. Health and Quality of Life Outcomes, 8(111). PMID:20920284 Cirillo, M. (2010). Evaluation of Glomerular Filtration Rate and of Albuminuria/Proteinuria. Journal of Nephrology, 23(2), 125–132. PMID:20213606 Conger, J. D. (1995). Interventions in clinical acute renal failure: What are the data? American Journal of Kidney Diseases, 26(4), 565–576. doi:10.1016/0272-6386(95)90590-1 PMID:7573008 Coons, S. J., Rao, S., Keininger, D. L., & Hays, R. D. (2000). A comparative review of generic qualityof-life instruments. PharmacoEconomics, 17(1), 13–35. doi:10.2165/00019053-200017010-00002 PMID:10747763 Cravedi, P., Ruggenenti, P., & Remuzzi, G. (2012). Proteinuria should be used as a surrogate in CKD. Nature Reviews. Nephrology, 8(5), 301–306. doi:10.1038/nrneph.2012.42 PMID:22391456 DAgati, V. D. (2008). The spectrum of focal segmental glomerulosclerosis: New insights. Current Opinion in Nephrology and Hypertension, 17(3), 271–281. doi:10.1097/MNH.0b013e3282f94a96 PMID:18408478 Davison, S. N., Jhangri, G. S., & Johnson, J. A. (2006). Cross-sectional validity of a modified Edmonton symptom assessment system in dialysis patients: A simple assessment of symptom burden. Kidney International, 69(9), 1621–1625. doi:10.1038j.ki.5000184 PMID:16672923

416

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Devarajan, P. (2006). Update on mechanisms of ischemic acute kidney injury. Journal of the American Society of Nephrology, 17(6), 1503–1520. doi:10.1681/ASN.2006010017 PMID:16707563 Dobbels, F., Moons, P., Abraham, I., Larsen, C. P., Dupont, L., & De Geest, S. (2008). Measuring symptom experience of side effects of immunosuppresive drugs: The Modified Transplant Symptom Occurrence and Distress Scale. Transplant International, 21(8), 764–773. doi:10.1111/j.1432-2277.2008.00674.x PMID:18435683 Earley, A., Miskulin, D., Lamb, E. J., Levey, A. S., & Uhlig, K. (2012). Estimating equations for glomerular filtration rate in the era of creatinine standardization: A systematic review. Annals of Internal Medicine, 156(11), 785–795. doi:10.7326/0003-4819-156-11-201203200-00391 PMID:22312131 Edgell, E. T., Coons, S. J., Carter, W. B., Kallich, J. D., Mapes, D. L., Damush, T. M., & Hays, R. D. (1996). A review of health-related quality of life measures used in end-stage renal disease. Clinical Therapeutics, 18(5), 887–938. doi:10.1016/S0149-2918(96)80049-X PMID:8930432 Edwards, I. R., & Aronson, J. K. (2000). Adverse drug reactions: Definitions, diagnosis, and management. Lancet, 356(9237), 1255–1259. doi:10.1016/S0140-6736(00)02799-9 PMID:11072960 Ferraro, P. M., Curhan, G. C., Gambaro, G., & Taylor, E. N. (2015). Total, dietary, and supplemental vitamin C intake and risk of incident kidney stones. American Journal of Kidney Diseases, 67(3), 400–407. doi:10.1053/j.ajkd.2015.09.005 PMID:26463139 Flythe, J. E., Powell, J. D., Poulton, C. J., Westreich, K. D., Handler, L., Reeve, B. B., & Carey, T. S. (2015). Patient-reported outcome instruments for physical symptoms among patients receiving maintenance dialysis: A systematic review. American Journal of Kidney Diseases, 66(6), 1033–1046. doi:10.1053/j. ajkd.2015.05.020 PMID:26210069 Franke, G. H., Reimer, J., Kohnle, M., Luetkes, P., Maehner, N., & Heemann, U. (1999). Quality of life in end-stage renal disease patients after successful kidney transplantation: Development of the ESRD Symptom Checklist - Transplantation Module. Nephron, 83(1), 31–39. doi:10.1159/000045470 PMID:10461033 Gohar, F., Greenfield, S. M., Beevers, D. G., Lip, G. Y. H., & Jolly, K. (2008). Self-care and adherence to medication: A survey in the hypertension outpatient clinic. BMC Complementary and Alternative Medicine, 8(8), 4–12. doi:10.1186/1472-6882-8-4 PMID:18261219 Gu, X., & Itoh, K. (2015). Factors behind dialysis patient satisfaction: Exploring their effects on overall satisfaction. Therapeutic Apheresis and Dialysis, 19(2), 162–170. doi:10.1111/1744-9987.12246 PMID:25363874 Hart, L. G., & Evans, R. W. (1987). The functional status of ESRD patients as measured by the sickness impact profile. Journal of Chronic Diseases, 40(Suppl 1), 117S–136S. doi:10.1016/S0021-9681(87)800413 PMID:3298302 Hays, R. D., Kallich, J., Mapes, D. L., Coons, S. J., Amin, N., Carter, W. B., & Kamberg, C. J. (1997). Kidney Disease Quality of Life Short Form (KDQOL-SFTM) version 1.3: A manual for use and scoring. Santa Monica, CA: Rand.

417

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Hays, R. D., Kallich, J. D., Mapes, D. L., Coons, S. J., & Carter, W. B. (1994). Development of the kidney disease quality of life (KDQOL) instrument. Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation, 3(5), 329–338. doi:10.1007/BF00451725 PMID:7841967 Hedayat, A. S., Wang, J., & Xu, T. (2015). Minimum clinically important difference in medical studies. Biometrics, 71(1), 33–41. doi:10.1111/biom.12251 PMID:25327276 Heerspink, H. J. L., Tighiouart, H., Sang, Y., Ballew, S., Mondal, H., Matsushita, K., & ... . (2014). GFR decline and subsequent risk of established kidney outcomes: A meta-analysis of 37 randomized controlled trials. American Journal of Kidney Diseases, 64(6), 860–866. doi:10.1053/j.ajkd.2014.08.018 PMID:25441439 Hollander-Rodriquez, J. C., & Calvert, J. F. J. (2006). Hyperkalemia. American Family Physician, 73(2), 283–290. PMID:16445274 Hull, S. K., Page, C. P., Skinner, B. D., Linville, J. C., & Coeytaux, R. R. (2006). Exploring outcomes associated with acupuncture. Journal of Alternative and Complementary Medicine (New York, N.Y.), 12(3), 247–254. doi:10.1089/acm.2006.12.247 PMID:16646723 Ide, K., Yamada, H., Kitagawa, M., Kawasaki, Y., Buno, Y., Matsushita, K., ... Umegaki, K. (2015). Methods for estimating causal relationships of adverse events with dietary supplements. BMJ Open, 5(11), e009038. doi:10.1136/bmjopen-2015-009038 PMID:26608636 IN-CAM. (2014). Framework of health outcome domains. Retrieved from www.incamresearch.ca/ content/browse-domain Jo, S. K., Rosner, M. H., & Okusa, M. D. (2007). Pharmacologic treatment of acute kidney injury: Why drugs havent worked and what is on the horizon. Clinical Journal of the American Society of Nephrology; CJASN, 2(2), 356–365. doi:10.2215/CJN.03280906 PMID:17699435 Johansen, K. L., Painter, P., Kent-Braun, J. A., Ng, A. V., Carey, S., Da Silva, M., & Chertow, G. M. (2001). Validation of questionnaires to estimate physical activity and functioning in end-stage renal disease. Kidney International, 59(3), 1121–1127. doi:10.1046/j.1523-1755.2001.0590031121.x PMID:11231369 Kang, G. W., Lee, I. H., Ahn, K. S., Lee, J., Ji, Y., & Woo, J. (2015). Clinical and psychosocial factors predicting helth-related quality of life in hemodialysis patients. Hemodialysis International. International Symposium on Home Hemodialysis, 19(3), 439–446. doi:10.1111/hdi.12271 PMID:25643587 Kellum, J. A., Unruh, M. L., & Murugan, R. (2011). Acute kidney injury. BMJ Clin Evid, 28, 2011. PMID:21443811 Kempen, G. I. J. M., van Sonderen, E., & Sanderman, R. (1997). Measuring health status with the Dartmouth COOP charts in low-functioning elderly. Do the illustrations affect the outcomes? Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation, 6(4), 323–328. doi:10.1023/A:1018427225299 PMID:9248314

418

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Kidney Disease; Improving Global Outcome (KDIGO) CKD Work Group. (2012a). KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney International. Supplement, 3(1), 34. Kidney Disease; Improving Global Outcome (KDIGO) CKD Work Group. (2012b). KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease. Kidney International. Supplement, 3(1), 1–150. Kirchgessner, J., Perera-Chang, M., Klinkner, G., Soley, I., Marcelli, D., Arkossy, O., ... Kimmel, P. L. (2006). Satisfaction with care in peritoneal dialysis patients. Kidney International, 70(7), 1325–1331. doi:10.1038j.ki.5001755 PMID:16900092 Krousel-Wood, M. A., Muntner, P., Joyce, C. J., Islam, T., Stanley, E., Holt, E. W., ... Webber, L. S. (2010). Adverse effects of complementary and alternative medicine on antihypertensive medication adherence: Findings from the cohort study of medication adherence among older adults. Journal of the American Geriatrics Society, 58(1), 54–61. doi:10.1111/j.1532-5415.2009.02639.x PMID:20122040 Lamb, E. J., Stevens, P. E., & Deeks, J. J. (2015). What is the best glomerular filtration marker to identify people with chronic kidney disease most likely to have poor outcomes? BMJ (Clinical Research Ed.), 350(g7667). PMID:25583704 Lameire, N. H., Bagga, A., Cruz, D., De Maeseneer, J., Endre, Z., Kellum, J. A., ... Vanholder, R. (2013). Acute kidney injury: An increasing global concern. Lancet, 382(13), 170–179. doi:10.1016/S01406736(13)60647-9 PMID:23727171 Laupacis, A., Muirhead, N., Keown, P., & Wong, C. (1992). A disease-specific questionnaire for assessing quality of life in patients on hemodialysis. Nephron, 60(3), 302–306. doi:10.1159/000186769 PMID:1565182 Laupacis, A., Pus, N., Muirhead, N., Wong, C., Ferguson, B., & Keown, P. (1993). Disease-specific questionnaire for patients with a renal transplant. Nephron, 64(2), 226–231. doi:10.1159/000187318 PMID:8321355 Levey, A. S., Inker, L. A., Matsushita, K., Greene, T., Willis, K., Lewis, E., ... Coresh, J. (2014). GFR decline as an end point for clinical trials in CKD: A scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration. American Journal of Kidney Diseases, 64(6), 821–835. doi:10.1053/j.ajkd.2014.07.030 PMID:25441437 Lin, M. Y., Chiu, Y. W., Chang, J. S., Lin, H. L., Lee, C. T. C., Chiu, G. F., & ... . (2015). Association of prescribed Chinese herbal medicine use with risk of end-stage renal disease in patients with chronic kidney disease. Kidney International, 5. PMID:26244923 Lopes, J. A., & Jorge, S. (2013). The RIFLE and AKIN classifications for acute kidney injury: A critical and comprehensive review. Clin Kidney J, 6(1), 8–14. doi:10.1093/ckjfs160 PMID:27818745 Luyckx, V. A. (2012). Nephrotoxicity of alternative medicine practice. Advances in Chronic Kidney Disease, 19(3), 129–141. doi:10.1053/j.ackd.2012.04.005 PMID:22578672

419

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Merkus, M. P., Jager, K. J., Dekker, F. W., Boeschoten, E. W., Stevens, P., & Krediet, R. T. (1997). Quality of life in patients on chronic dialysis: Self-assessment 3 months after the start of treatment. American Journal of Kidney Diseases, 29(4), 584–592. doi:10.1016/S0272-6386(97)90342-5 PMID:9100049 Miller, N. L., & Lingeman, J. E. (2007). Management of kidney stones. BMJ (Clinical Research Ed.), 334(7591), 468–472. doi:10.1136/bmj.39113.480185.80 PMID:17332586 Moreiras-Plaza, M., Blanco-Garcia, R., Cossio-Aranibar, C. R., & Rodriguez-Goyanes, G. (2011). Assessment of health-related quality of life: The cinderella of peritoneal dialysis. International Journal of Nephrology, 2011, 528685. doi:10.4061/2011/528685 PMID:21808736 Moretti, E., & Funk, D. (2008). Endocrine and electrolyte disorders. In M. Newman, L. Fleisher, & M. Fink (Eds.), Perioperative Medicine: Managing for outcome (pp. 627–648). Philadelphia: Saunders. Murphy, E. L., Murtagh, F. E., Carey, I., & Sheerin, N. S. (2009). Understanding symptoms in patients with advanced chronic kidney disease managed without dialysis: Use of a short patient-completed assessment tool. Nephron. Clinical Practice, 111(1), c74–c80. doi:10.1159/000183177 PMID:19088482 Murtagh, F. E. M., Addington-Hall, J., & Higginson, I. J. (2007). The prevalence of symptoms in end-stage renal disease: A systematic review. American Journal of Kidney Diseases, 14(1), 82–99. PMID:17200048 Naranjo, C. A., Busto, U., Sellers, E. M., Sandor, P., Ruiz, I., Roberts, E. A., ... Greenblatt, D. (1981). A method for estimating the probability of adverse drug reactions. Clinical Pharmacology and Therapeutics, 30(2), 239–245. doi:10.1038/clpt.1981.154 PMID:7249508 National Kidney Foundation. (2002). Evaluation of laboratory measurements for clinical assessment of kidney disease. American Journal of Kidney Diseases, 39(2suppl 1), S76–S110. doi:10.1053/ ajkd.2002.30944 Ogutmen, B., Yildirim, A., Sever, M. S., Bozfakioglu, S., Ataman, R., Erek, E., ... Emel, A. (2006). Health-related quality of life after kidney transplantation in comparison intermittent hemodialysis, peritoneal dialysis, and normal controls. Transplantation Proceedings, 38(2), 419–421. doi:10.1016/j. transproceed.2006.01.016 PMID:16549136 Palevsky, P. M., Liu, K. D., Brophy, P. D., Chawla, L. S., Parikh, C. R., Thakar, C. V., ... Weisbord, S. D. (2013). KDOQI US commentary on the 2012 KDIGO clinical practice guideline for acute kidney injury. American Journal of Kidney Diseases, 61(5), 649–672. doi:10.1053/j.ajkd.2013.02.349 PMID:23499048 Palliative Care Outcome Scale. (2012). IPOS-Renal. Retrieved from http://pos-pal.org/maix/ipos-renalin-english.php Paterson, C. (1996). Measuring outcomes in primary care: A patient generated measure, MYMOP, compared with the SF-36 health survey. BMJ (Clinical Research Ed.), 312(7037), 1016–1020. doi:10.1136/ bmj.312.7037.1016 PMID:8616351 Paterson, C., & Britten, N. (2000). In oursuit of patient-centered outcomes: A qualitative evaluation of the Meausre Yourself Medical Outcome Profile. Journal of Health Services Research & Policy, 5(1), 27–36. doi:10.1177/135581960000500108 PMID:10787584

420

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Penniston, K. L., & Nakada, S. Y. (2013). Development of an instrument to assess the health related quality of life of kidney stone formers. The Journal of Urology, 189(3), 921–930. doi:10.1016/j.juro.2012.08.247 PMID:23017521 Polus, B. I., Kimpton, A. J., & Walsh, M. J. (2011). Use of the measure your medical outcome profile (MYMOP2) and W-BQ12 (Well-Being) outcomes measures to evaluate chiropractic treatment: An observational study. Chiropr Man Therap, 19(1), 7. doi:10.1186/2045-709X-19-7 PMID:21418608 Rabin, R., & de Charro, F. (2001). EQ-5D: A measure of health status from the EuroQol Group. Annals of Medicine, 33(5), 337–343. doi:10.3109/07853890109002087 PMID:11491192 Raja, A., ONeill, C., Joshi, H. B., & Salek, S. (2014). Re: development of an instrument to assess the health related quality of life of kidney stone formers: K.L. Penniston and S.Y. Nakada J Urol 2013;189:921930. The Journal of Urology, 192(1), 280–281. doi:10.1016/j.juro.2014.01.112 PMID:24742763 RAND Health. (2015). Dialysis patient satisfaction survey (DPSS). Retrieved from www.rand.org/ health/surveys_tools/dpss.html Refolo, P., Minacori, R., Mele, V., Sacchini, D., & Spagnolo, A. G. (2012). Patient-reorted outcomes (PROs): The significance of using humanistic measures in clinical trial and clinical practice. European Review for Medical and Pharmacological Sciences, 16(10), 1319–1323. PMID:23104647 Rettig, R. A., Sadler, J. H., Meyer, K. B., Wasson, J. H., Parkerson, G. R. Jr, Kantz, B., ... Patrick, D. L. (1997). Assessing health and quality of life outcomes in dialysis: A report on an institute of medicine workshop. American Journal of Kidney Diseases, 30(1), 140–155. doi:10.1016/S0272-6386(97)90578-3 PMID:9214415 Revicki, D., Hays, R. D., Cella, D., & Sloan, J. (2008). Recommended methods for determining responsiveness and minimally important differences for patient-reported outcomes. Journal of Clinical Epidemiology, 61(2), 102–109. doi:10.1016/j.jclinepi.2007.03.012 PMID:18177782 Robinson-Cohen, C., Littman, A. J., Duncan, G. E., Roshanravan, B., Ikizler, T. A., Himmelfarb, J., & Kestenbaum, B. R. (2013). Assessment of physical activity in chronic kidney disease. Journal of Renal Nutrition, 23(2), 123–131. doi:10.1053/j.jrn.2012.04.008 PMID:22739659 Ronco, C., & Bellomo, R. (2003). Prevention of acute renal failure in the critically ill. Nephron. Clinical Practice, 93(1), c13–c20. doi:10.1159/000066646 PMID:12411754 Rubin, H. R., Jenckes, M., Fink, N. E., Meyer, K., Wu, A. W., Bass, E. B., ... Powe, N. R. (1997). Patients view of dialysis care: Development of a taxonomy and rating of importance of different aspects of care. American Journal of Kidney Diseases, 30(6), 793–801. doi:10.1016/S0272-6386(97)90084-6 PMID:9398123 Sakthong, P., & Kasemsup, V. (2012). Health utility measured with EQ-5D in Thai patients undergoing peritoneal dialysis. Value in Health, 15(1Suppl), S79–S84. doi:10.1016/j.jval.2011.11.005 PMID:22265072 Sanoff, S., & Okusa, M. (2011). Possible prevention and therapy of postischemic acute tubular necrosis. Retrieved from www.uptodate.com/contents/possible-prevention-and-therapy-of-postischemic-ischemicacute-tubular-necrosis

421

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Sathvik, B. S., Parthasarathi, G., Narahari, M. G., & Gurudev, K. C. (2008). An assessment of the quality of life in hemodialysis patients using the WHOQoL-BREF questionnaire. Indian J Nephrol, 18(4), 141–149. doi:10.4103/0971-4065.45288 PMID:20142925 Schena, F. P. (2000). Epidemiology of end-stage renal disease: International comparison of renal replacement therapy. Kidney International, 57(Suppl 74), S39–S45. doi:10.1046/j.1523-1755.2000.07407.x Skevington, S. M., Lotfy, M., & OConnell, K. A. (2004). The World Health Organizations WHOQOLBREF quality of life assessment: Psychometric properties and results of the internationl field trial. A report from the WHOQOL group. Quality of Life Research: An International Journal of Quality of Life Aspects of Treatment, Care and Rehabilitation, 13(2), 299–310. doi:10.1023/B:QURE.0000018486.91360.00 PMID:15085902 Spiegel, D. M., Evans, R. W., Gitlin, M., & Mayne, T. J. (2009). Psychometric evaluation of the National Kidney Dialysis and Kidney Transplantation Study symptom checklist: Reliability and validity. Nephrology, Dialysis, Transplantation, 24(2), 619–625. doi:10.1093/ndt/gfn523 PMID:18799605 Tangkiatkumjai, M., Boardman, H., Praditpornsilpa, K., & Walker, D.-M. (2013). Prevalence of herbal and dietary supplement usage in Thai outpatients with chronic kidney disease: A cross-sectional survey. BMC Complementary and Alternative Medicine, 13(1), 153. doi:10.1186/1472-6882-13-153 PMID:23815983 Tangkiatkumjai, M., Boardman, H., Praditpornsilpa, K., & Walker, D.-M. (2015). Association of herbal and dietary supplements with progression and complications of chronic kidney disease: A prospective cohort study. Nephrology (Carlton, Vic.), 20(10), 679–687. doi:10.1111/nep.12531 PMID:26040915 Teo, B. W., Xu, H., Wang, D., Li, J., Sinha, A. K., Shuter, B., ... Lee, E. J. C. (2011). GFR estimating equations in a multiethnic Asian population. American Journal of Kidney Diseases, 58(1), 56–63. doi:10.1053/j.ajkd.2011.02.393 PMID:21601325 The National Collaborating Centre for Chronic Conditions (Great Britain). (2008). Chronic kidney disease: national clinical guideline for early identification and management in adults in primary and secondary care (1st ed.). London: Royal College of Physicians. The Nephrology Society of Thailand. (2009). Clinical practice guidelines for pre-dialysis patients in 2009 (1st ed.). Bangkok: The Nephrology Society of Thailand. The Uppsala Monitoring Centre. (2015). The use of the WHO-UMC system for standardised case causality assessment. Retrieved from http://who-umc.org/Graphics/24734.pdf The WHOQoL Group. (1995). The World Health Organization Quality of Life assessment (WHOQoL): Position paper from the World Health Organization. Social Science & Medicine, 41(10), 1403–1409. doi:10.1016/0277-9536(95)00112-K PMID:8560308 Travers, K., Martin, A., Khankhel, Z., Boye, K. S., & Lee, L. J. (2013). Burden and management of chronic kidney disease in Japan: Systematic review of the literature. Int J Nephrol Renovasc Dis, 6, 1–13. doi:10.2147/IJNRD.S30894 PMID:23319870

422

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Tsai, S. Y., Tseng, H. F., Tan, H. F., Chien, Y. S., & Chang, C. C. (2009). End-stage renal disease in Taiwan: A case-control study. Journal of Epidemiology, 19(4), 169–176. doi:10.2188/jea.JE20080099 PMID:19542686 Tsutsui, H., Ohkubo, T., Tsuruta, Y., Kato, S., Yasuda, Y., & Oshida, Y. (2014). Development and validation of a short-version checklist for patients undergoing hemodialysis based on the International Classification of Functioning, Disability and Health. Clinical and Experimental Nephrology, 28. PMID:25543186 Tsutsui, H., Ojima, T., Tsuruta, Y., Kato, S., Yasuda, Y., & Oshida, Y. (2014). Validity of a checklist for hemodialysis patients based on the International Classification of Functioning, Disability and Health. Therapeutic Apheresis and Dialysis, 18(5), 473–480. doi:10.1111/1744-9987.12163 PMID:25195794 Unruh, M., Yan, G., Radeva, M., Hays, R. D., Benz, R., Athienites, N. V., & ... . (2003). Bias in assessment of health-related quality of life in a hemodialysis population: A comparison of self-administered and interview-administered surveys in the HEMO study. Journal of the American Society of Nephrology, 14(8), 2132–2141. doi:10.1097/01.ASN.0000076076.88336.B1 PMID:12874468 Verhoef, M. J., Vanderheyden, L. C., Dryden, T., Mallory, D., & Ware, M. A. (2006). Evaluating complementary and alternative medicine interventions: In search of appropriate patient-centered outcome measures. BMC Complementary and Alternative Medicine, 6(1), 38. doi:10.1186/1472-6882-6-38 PMID:17118197 Wakefield, M. L. (2014). Case report: The effects of massage therapy on a woman with thoracic outlet syndrome. Int J Ther Massage Bodywork, 7(4), 7–14. PMID:25452819 Wardle, J. J. L., & Adams, J. (2014). Indirect and non-health risks associated with complementary and alternative medicine use: An integrative review. European Journal of Internal Medicine, 6(4), 409–422. Ware, J. E., & Sherbourne, C. D. (1992). The MOS 36-item short-form helth survey (SF-36). I. Conceptual framework and item selection. Medical Care, 30(6), 473–483. doi:10.1097/00005650-19920600000002 PMID:1593914 Wasserfallen, J. B., Moinat, M., Halabi, G., Saudan, P., Perneger, T., Feldman, H. I., ... Wauters, J. P. (2006). Satisfaction of patients on chronic haemodialysis and peritoneal dialysis. Swiss Medical Weekly, 136(13-14), 210–217. PMID:16633970 Weisbord, S. D., Fried, L. F., Arnold, R. M., Rotondi, A. J., Fine, M. J., Levenson, D. J., & Switzer, G. E. (2004). Development of a symptom assessment instrument for chronic hemodialysis patients: The Dialysis Symptom Index. Journal of Pain and Symptom Management, 27(3), 226–240. doi:10.1016/j. jpainsymman.2003.07.004 PMID:15010101 Wiklund, I. (1990). The Nottingham Health Profile - a measure of health-related quality of life. Scandinavian Journal of Primary Health Care. Supplement, 1, 15–18. PMID:2100359 Wu, A. W., Fink, N. E., Cagney, K. A., Bass, E. B., Rubin, H. R., Meyer, K. B., ... Powe, N. R. (2001). Developing a health-related quality of life measure for end-stage renal disease: The CHOICE Health Experience Questionnaire. American Journal of Kidney Diseases, 37(1), 11–21. PMID:11136162

423

 Approach to Evaluating Effects of CAM Use in Kidney Diseases

Wyld, M., Morton, R. L., Hayen, A., Howard, K., & Webster, A. C. (2012). A systematic review and meta-analysis of utility-based quality of life in chronic kidney disease. PLoS Medicine, 9(9), e1001307. doi:10.1371/journal.pmed.1001307 PMID:22984353 Yang, F., Lau, T., Lee, E., Vathsala, A., Chia, K. S., & Luo, N. (2015). Comparison of the preferencebased EQ-5D-5L and SF-6D in patients with end-stage renal disease (ESRD). The European Journal of Health Economics, 16(9), 1019–1026. doi:10.100710198-014-0664-7 PMID:25519850 Zyoud, S. H., Daraghmeh, D. N., Mezyed, D. O., Khdeir, R. L., Sawafta, M. N., Ayaseh, N. A., ... AlJabi, S. W. (2016). Factors affecting quality of life in patients on haemodialysis: A cross-sectional study from Palestine. BMC Nephrology, 17(1), 44. doi:10.118612882-016-0257-z PMID:27117687

KEY TERMS AND DEFINITIONS Acute Kidney Injury: A decline in kidney function within less than 3 months. Clinical Outcome: A positive outcome of intervention which alters the physiological status and is measured by a laboratory test or physical examination. Electrolyte Imbalance: An abnormality of a serum level of electrolytes which may be increased or decreased from their normal value. Estimated Glomerular Filtration Rate: A standard parameter of the measurement of kidney function. Health-Related Quality of Life: A perception of an individual in terms of their physical, mental and social well-being which is influenced by their health status. Humanistic Outcome: A positive outcome of intervention which alters the quality of life, symptoms, and the patient’s satisfaction with health care. Indirect Risk: An unwanted harm which does not directly result from an exposure. Progression of Chronic Kidney Disease: A constant decline in kidney function among people with chronic kidney disease. Proteinuria: A parameter which is measured by amounts of protein in urine and indicates the progression of kidney diseases. Renal Adverse Effect: An unwanted effect of renal problems which may be associated with either conventional or alternative medicine.

This research was previously published in Complementary and Alternative Medicine and Kidney Health edited by Mayuree Tangkiatkumjai, Annalisa Casarin, Li-Chia Chen, and Dawn-Marie Walker, pages 60-99, copyright year 2018 by Medical Information Science Reference (an imprint of IGI Global).

424

425

Chapter 21

Coping and Transition in Young People With Chronic Kidney Disease (CKD) – Maintaining Best Practice: Paediatric Nephrology Shahid Muhammad The Renal Patient Support Group (RPSG), UK

ABSTRACT Most young people coping with Chronic Kidney Disease (CKD) know that over time this disease can affect their physical health, lifestyle and psychological wellbeing. Transition services and experiences differ; some young people also have better coping strategies than others. This article explores 1) whether there is a need for a transition reorganization to maintain best practice for young people with CKD and 2) what would make more effective coping and transition research for the future. Three coordinated meetings took place inviting young people to contribute their insights on transition and coping questions. 1) Twelve (12) young people from the Renal Patient Support Group (RPSG) online invited (mean age = 15 years), 2) Nine (9) young people attended a Medicines for Children Research Network (MCRN) Young Person’s Advisory Group (YPAG) at the Birmingham Children’s Hospital, UK (mean age = 14 years) and 3) Nine (9) from the MCRN YPAG meeting at Great Ormond Street Hospital, London UK (mean age = 15 years). Young people’s contribution can be summarized: 1) The ‘rounded experiences’ before, during and after transition of young people with CKD are still required, 2) It is important to see if there is an association between positive coping and smoother transition, 3) Need to appreciate care needs to be better integrated for young people ahead of their transition to achieve best practice and 4) Supporting young people with CKD to build aptitudes is important so they become independent and cope with their health. An overall transition guideline and reorganization that factors in coping strategies should be prompted in future research for teams supporting the care for young people to maintain best practice.

DOI: 10.4018/978-1-5225-7122-3.ch021

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

INTRODUCTION An estimated total of 861 young people under 18 years with CKD were receiving treatment at paediatric nephrology centres in the UK in 2012. At the census date, 80.2% had a functioning kidney transplant, 10.6% were receiving Renal Replacement Therapies (RRTs) such as Haemodialysis (HD) and 9.2% were receiving Peritoneal Dialysis (PD). Patients aged 16–18 years may receive their medical care either in a paediatric or in an adult nephrology centre. As data was incomplete for the 16 to 18 year old adolescent patients, they have been excluded from the majority of subsequent analyses (particularly when describing incidence and prevalence rates). There were 679 young people under 16 years of age receiving RRT in the UK in 2012. No young people received a transplant and the majority of patients were being treated with PD (57.1%). This contrasts with older patients in the 12 to 15.99 year age group where 85% had a functioning graft and similar proportions were on HD and PD. Subsequent analysis of RRT modality by gender and ethnicity showed no difference. However, as absolute sub-group numbers are small, caution is needed in conducting any comparative analyses. There were 117 patients under 18 years of age who commenced RRT at paediatric renal centres in 2012. Analyses are restricted to the 108 patients who were under 16 years of age.

AIM This article seeks to identify 1) is there is a need for a transition reorganization to maintain best practice for young people in CKD and 2) what would make more effective coping and transition research for the future.

CHRONIC KIDNEY DISEASE (CKD) Chronic Kidney Disease (CKD) is a long-term condition and has been described as the gradual, and usually permanent, loss of kidney function over time (Fogo 2007). Literature has explored different concepts of coping (Muhammad et al. 2012a) and a review has summarized how young people cope with CKD (Muhammad et al. 2012b). Positive coping may also be important potentially allowing a smoother transition. More recent research has informed that coping in young people needs to be better understood (In press, Muhammad et al. 2015). There is also evidence to suggest that rates of acute rejection are higher when young people transition from paediatric renal care to adult renal services (Harden et al. 2012). By implementing an integrated transition clinic, coupled with improving healthcare experiences, can improve young people’s adherence to regular medication as judged by reduced transplant failure rates (Harden et al. 2012). The ability to treat young people with chronic disease, coupled with the inability to offer an absolute cure, causes ongoing complications in young people with CKD (Fowler and Baas 2006; Eiser and Jenney 2007; Eiser et al. 1999). There are good examples of toolkits and frameworks allowing commissioners and providers to evaluate quality criteria or generic standards for health services for young people with a range of health conditions (including the Department of Health, Quality Criteria for Young People

426

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

Friendly Health Services, 2011).There are also evaluation instruments that specifically explore the care of young people with kidney disease (as listed in Eiser & Morse 2001). The British Association for Paediatric Nephrology (BAPN) has also developed a series of questionnaires to evaluate the experiences of young people and their families in the care of young people on HD, PD and with kidney transplants (BAPN 2011). Although patient reported experience measures (PREMS) can provide a helpful indication of patients’ and their carers’ perspectives on their care, by their nature these reflect the process rather than the outcome. Young people with CKD can be challenged with attaining prime development. Young people also require time to cope with this illness or accompanying medical complication (Boekaerts and Roder 1999). The lasting prognosis rate amongst young people needing RRT is 79% in the first decade and 66% in the second decade (McDonald & Craig 2004). Despite progress in prognosis, survival ratios in young people needing treatment stay significantly higher and in spite of enhanced practices in the current period, young people with CKD and family members are still under substantial tension (Reynolds et al. 1986).

WHAT DOES IT MEAN TO COPE WITH CKD? Retrospective research provides detail on coping under different circumstances (Lazarus and Folkman 1984; Lazarus 1985; Lazarus 1993a; Lazarus 1993b). Living with chronic disease can be viewed as stressful, making the individual vulnerable to a number of issues relating to their health in the long-term including situations that pose serious challenges to adaptation (Baum 2010; Ridder and Schreurs 1996; Moos and Schaeffer, 1984; Zautra, 1996). Chronically ill patients have to cope with these stressful situations and, depending on the results of their coping efforts; they may be able to maintain adequate levels of physical, social and emotional functioning. Inspired by the stress-coping model of Lazarus (Folkman 2008; Folkman 2010; Folkman and Moskowitz 2004) much research has been done on coping and adjustment of patients with chronic conditions (for a review see Ridder and Schreurs, 1996; Maes et al.1996). Although research has provided valuable insights into the ways patients cope with their chronic illness and the effects of coping on chronic illness adjustment, it is difficult to determine the precise value of such a wealth of information for different chronic conditions. It is important to gain better insight into the type of stressors experienced by patients suffering from different chronic diseases as information on the nature of disease-related stressors may contribute to a better understanding of patients’ coping strategies. Coping research informs that young people who adopt positive coping strategies is effective in young CKD patients (Lindqvist 1998a; Lindqvist 1998b; Lindqvist, 2004; In press, Muhammad et al. 2015; Kaltsouda et al. 2011; Harwood et al. 2009). Some of the coping strategies used by young people include confrontational coping and supportive and self-reliance approaches. Young people involved in their own health care increasingly encompasses the acquisition of self-care skills, health information and self-monitoring of their illness (Giarelli et al. 2008). There has been qualitative research describing Health-Related Quality of Life (HRQOL) and experiences of young people with CKD (Reinfjell 2006; Baum 2010; Goldstein et al. 2008; Goldstein et al. 2009; Marciano et al. 2011; Nicholas et al. 2011; Park et al. 2012) Poor coping has a profound impact on young lives. Young people have described a range of challenges and experiences including not feeling ‘normal’, frequent absence from school, relying

427

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

on family, friends, and healthcare providers in times of adversity (Nicholas et al. 2011). Many young people with CKD (post-transplant) are subject to feelings of helplessness, a perceived lack of control, and a negative health outlook, resulting in a reduced prognosis (Fowler and Baas 2006). Coping can be assessed and evaluated.

ISSUES AND CONCERNS WITH CURRENT PRACTICES The sum of young people with CKD is now increasing and more young people are being treated between 13 specialist hospitals in England, of which 10 provide renal transplantation services (compared with over 37,000 adults) (Department of Health 2006a). It has been reported that the incidence of RRT in young people is 7 - 8 PMP below the age of 16 years (Lewis et al. 2010). Frequencies can fluctuate around 55 and 62 PMP (van der Heijden et al. 2004). Forty years ago, young people with CKD died. Now, morbidity has improved by the availability of multiple treatment modalities. In the majority, young people are treated with kidney replacement therapies, which remain the foremost effective methods of treatment (McDonald and Craig 2004). Paediatric renal teams endeavour to identify a suitable donor for transplantation as swiftly as possible, because patient survival depends upon the availability of kidneys (McDonald & Craig 2004; Watson 1996). Care for young people in CKD stages (1 to 3) and (4 to 5) has been described in literature (Murphy et al. 2008a; Murphy et al. 2008b). The rate of graft loss in young people is has been a problem for young people (Watson 2000) and this is associated with poor transition into adult services (Harden et al. 2012). Effective transition must be seen as an integral and routine component of the medical care provided to young people with kidney disease (Harden et al. 2012). Research has highlighted various perspectives on transition (Ajarmeh et al. 2012; Blum et al. 1993; Blum 1995; Bowes et al. 1995; Chaturvedi et al. 2009; Freed and Hudson 2006; Kennedy et al. 2007; McDonagh and Kelly 2007; Myers 2002; Rosen et al. 2003; Scal 2002; Scal and Ireland 2005; Watson 2005; Watson et al. 2011; Webb et al. 2010) including age-appropriate clinics for young people, the availability of a service directory with information on lifestyle, helpful contacts and links to additional information can support the most important elements of transition (Harden et al. 2012). The issue is that there is still no overall CKD transition guideline to support the process for young people coping with CKD.

CKD AND TRANSITION SERVICES Despite young people’s health being a higher priority on health policy agendas, implementation of youthfriendly services including transitional care has been frustratingly slow (McDonagh 2013). Although there have been great advances in paediatric nephrology and the wider renal specialty, young people still have challenges during the transition process and thereafter (Myers 2002). All youth, whatever their physical, cognitive, and/ or social circumstances, are confronted with difficulties that test their ability to cope and this can specifically impede on the emotional well-being on a young person living with CKD. In renal care, young people who transfer from paediatric to adult services or present directly to adult services often struggle with adjustment issues and problems with denial and concordance. There have also been several tools to support the transition process, such as the Transition Checklist by (Whitehouse and Paone 1998). Transition can begin at any time during paediatric renal care but generally should 428

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

technically begin by the start of academic year 9 and can continue until the young adult is in their twenties. Transfer is an event that should occur at a time agreed by the adolescent and their parents, as well as by the paediatric and adult renal staff, during the transition process. The timing of transfer will be influenced by individual Trust Policies but generally should not take place before the end of academic year 11 (The BAPN 2009). The present transition remit is as follows: 1) young people in academic year 9 or above with a functioning renal transplant, 2) young people in academic year 9 or above with CKD and anticipated to require renal replacement therapy (RRT) within one year, 3) young adults less than 20 years of age presenting to an adult renal unit with end stage renal failure, or with chronic kidney disease and anticipated to require RRT within one year (The BAPN 2009).

WHAT DOES THE RENAL REGISTRY SAY ABOUT YOUNG PEOPLE WITH CKD? Renal registry data indicates there were 1,656 young people under 16 years of age who had received renal replacement (RRT) in the UK over the 15-year period between (1998 to 2012). Analysis of CKD demographics for young people less than 16 years of age over this period included 547 patients reported to the paediatric registry between (1998 to 2002), 536 between (2003 and 2007), 573 between (2008 and 2012). Comparing the current 5-year period with the two previous 5-year periods, there has been an overall increase in the number of people treated on a form of RRT, particularly in people aged less than two years. The percentage of young people receiving RRT with major reported co-morbidities over the last 15 years includes Syndromic diagnoses (8.6%), congenital abnormalities (8.0%) and developmental delay (7.9%). These were the most common reported comorbidities in (2008 to 2012), with little change in the percentage of young people receiving RRT with a reported co-morbidity over the last 15 years. Over the last 15 years, pre-emptive transplantation was seen to occur in 32.5% of young people under 16 years of age. The rate of pre-emptive transplantation has increased over the past 15 years (26.2% in 1998–2002 to 36.3% in 2008 to 2012). There were significantly lower rates of pre-emptive transplantation in girls and ethnic minorities and further detailed studies investigating these would be important. Unfortunately, (2013 to 2015) data does not exist in the present (Renal Registry, 2013).

PATIENT REPORTED OUTCOME MEASURES (PROMS) CKD and the need for RRT in young people can lead to severe impairment of physical development and psychosocial integration; many complications continue into adult life and compromise their chances of leading a successful work and social life (Renkema et al. 2011). Increasingly, young patients themselves can help professionals to better understand the care they require, and this can lead to improved patient reported outcome measures (or PROMS), (British Association for Paediatric Nephrology - BAPN 2011). Even more assistance is required for young people with CKD because they: 1) live with the actual or threatened loss or impairment of body functioning such as weight loss, weakness, lack of energy and impaired cognition, 2) can be difficult to understand as early kidney disease may present few symptoms, 3) tend to have different clinical backgrounds to those of adult sufferers of kidney disease and respond differently to the various treatments, 4) have a unique need for play and/or education during their illness and its treatment, 5) may have a lifetime of kidney disease and treatment ahead, making them vulnerable 429

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

to long-term complications such as restricted growth, which can affect long-term physical and psychosocial development (Silkensen 2000), and 6) have to make a potentially difficult transition to adulthood and adult services (Department of Health 2006b).

THE READY STEADY GO TRANSITION SURVEY AND THE NATIONAL INSTITUTE FOR HEALTH RESEARCH (NIHR) The Ready Steady Go Transition Survey (University Hospital, Southampton UK 2014) is a novel transition programme for patients with Long-Term Conditions (LTCs), initially introduced at Southampton University NHS Hospitals Trust. Some paediatric renal centres are now implementing the Ready Steady Go Transition Survey to gain a better understanding of transition experiences; in June 2015, there will be a workshop at the University of Brighton allowing professionals the opportunity to gain a more understanding of how the survey works, to see what further practices are required and establish if this survey can/ should be applied more widely. The National Institute for Health Research (NIHR) is also seeking to develop an over-arching transition guideline that caters for all paediatric specialities, however in a paediatric renal population, longitudinal data factoring in coping strategies collectively with transition context is still necessary because these young people will cope with this ‘clinical syndrome’ over a lifetime; there are various parameters of CKD that need to be considered as part of the intricate care provided for this young population.

PUBLIC AND PATIENT INVOLVEMENT (PPI) By encouraging partnerships and inviting patient and public involvement (PPI) with “expertise”, who can effectively and efficiently add to this important discussion, there is now ever more need for patients and professionals to work in partnership (Prainsack, 2014) in developing prospective research proposals dialogue with and social services, to prompt tighter integrated care (Hartzler and Pratt 2011; Huh and Ackerman 2012a). Such partnerships would not only enable an individual patient to better understand their health and treatment, thus realising the model of the ‘Expert Patient’, but would also bring about a deeper understanding of, research and engagement. INVOLVE have set out a document highlighting strategies for diversity and inclusion in public involvement (INVOLVE 2012). Any prospective proposal should be PPI-driven to ensure research is all inclusive (Hartzler and Pratt 2011; Huh and Ackerman 2012a; Huh et al. 2012b; Huh et al. 2012c Huh et al. 2013a; Huh et al. 2013b).

METHODS Three meetings took place where young people with ranging chronic illnesses were invited to contribute their insights on semi-structured transition and coping questions to help inform future CKD research. Twelve (12) young people (6 male; 6 female) from the Renal Patient Support Group (RPSG) online were invited on 13th December 2013 (mean age = 15 years). The RPSG online group was provided transition and coping questions and these were discussed through a moderated private chat session via the RPSG and overseen by an RPSG administrator. 2) Nine (9) young people (4 male; 5 female) attended a Medicines 430

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

for Children Research Network (MCRN) Young Person’s Advisory Group (YPAG) at the Birmingham Children’s Hospital, UK (mean age = 14 years) on 17th February 2014 and 3) nine (9) young people (4 male; 5 female) also attended a MCRN YPAG meeting at Great Ormond Street Hospital, London UK (mean age = 15 years) on 22nd February 2014. The two MCRN groups were provided transition and coping questions and these were discussed to gain some further context on what would make coping and transition more effective. To ascertain insights from young people on transition questions, these were originally developed having reviewed You’re Welcome Criteria and Transition Service work by the (Department of Health 2011) and the Shared-Decision Making work by (Walsh et al. 2012). To ascertain further insights into the coping strategies of young people via these group meetings to help inform future research, the lead author discussed the same coping interview questions as outlined by (anticipated publication, In press, Muhammad et al. 2015). Table 1 highlights the transition research questions that were distributed through the RPSG online group and MCRN YPAG meetings. Table 2 summarizes the coping research questions that were distributed through the RPSG online group and the MCRN YPAG meetings.

RESULTS Renal Patient Support Group (RPSG) Online Group Meeting: 21st December 2013 Table 3 and 4 provide feedback points from the RPSG online group based on the questions discussed. Table 1. Transition: Semi-structured questions Before Transferring to Adult Services • Were you given enough information about what would happen? • Do you think you have been provided enough time)? • Are there any methods you would prefer to receive information by (e.g., written, online or phone calls)? • Did you have a say on the timing? • Did you get to meet the people who would be caring for you? • Was there anything that could have been better in preparing you for transferring in the lead-up to it? During the Transfer Process • Did you have a planned programme? • Did you have a key worker or a named individual to help plan your transfer? • Did you have an opportunity to meet with others who are going through transition? • Would you have liked to know more about what was happening? • Was it important for you to have someone to speak to who is the same gender as you? After Transition and On-Going Care • How do you feel about the care you received now that you have transferred to adult care? • Do you think that the transfer was smooth? • Are you confident about looking after your own condition? • Did paediatric and adult healthcare providers communicate well with each other? • Would you know what to do or who to speak to if there was a medical emergency? • Do you have confidence and trust in the new provider? • Was there anything that could be done to prepare you better?

431

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

Table 2. Coping: Semi-structured research questions General • Tell us/ me your name/s? • What are your favourite pastimes? Living and Coping • Could you tell me what might trigger you to get stressed or feel under pressure? • Think back to a time when you were in school and found it difficult; what did you do to cope? • Could you give me an example of tough situation you’ve had? • What do you do when the situation is at its worst? Family and Friends • When you can’t cope; who do you talk too? • Think back to a time when you needed help; did you have to cope all by yourself or did you seek support? If so, who from? Coping Ways and Planning • I tend to go to the gym quite a bit to help me deal with stress or coping and it makes me feel stronger, what do you do? • I often laugh quite a lot to help me cope; what helps you cope with difficult situations? • When you had to cope; did you manage well or badly? • What have you tried before? • When I can’t cope, I get a little frustrated. How do you feel when you can’t cope? • Thinking back to when a situation where it became overwhelming – how do you handle it? • Think back to an experience you had; how did you stop things from getting worse? Coping and Relief • How do you think you could be better prepared to cope with tough situations? • What helps you relax? • What activities do you like to get involved in? • What do you like about coming to this hospital?

Table 3. Transition: Feedback points • Transition questions are really quite good, but a little lengthy, perhaps a future investigator could shorten or more time should be dedicated to questions related to transition and not so much how information is received? • All participants felt that whilst future research to retrieve data transition is important, any investigator who has a personal insight of paediatric renal care would be advantageous. • Relating to transition-based questions, it will be important to ‘stick’ to these set questions which will provide most ‘relevant’ insight relating to transition more so than how information is received/ how information is interpreted. Again, any investigator should look to highlight questions using prompts for discussion to help retrieve ‘rich’ context. • Any future researcher looking to explore transition-based research information should aim to collect context relating to these questions at several time points over a set duration. • Any future research relating to transition work should look to involve more than one NHS site and a researcher should follow up transition process to gain their experiences before, during and after. • A future research should perhaps think about having interviews timed. • A future investigator looking to explore transition should also try and involve up to 100 young people to also try and complete a valid transition questionnaire/ survey (with a choice of completing on either paper or online). • Any transition questionnaire/ survey should be possible to complete in 10-15 minutes.

Medicine Clinical Research Network (MCRN) Young Persons Advisory Group (YPAG), Birmingham: 17th February 2014 Table 5 and 6 provide feedback points from the MCRN YPAG meeting in Birmingham based on the questions discussed.

432

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

Table 4. Coping: Feedback points • The coping-based questions are simple and easy to understand, which is really good. It would also be good if an investigator could look to elaborate on all points to form more in-depth discussions with young people in CKD • Again, discussions could quite easily go over a specified duration, so a future the investigator should perhaps have the interviews timed. • Future research should look to potentially have 0, 6, 12, and 18 months as the dedicated time points to conduct interviews, hopefully allowing robust insights on coping with CKD. • A future investigator looking to explore coping should try and involve up to 100 young people to also try and complete a valid coping questionnaire/ survey (with a choice of completing on either paper or online). • Any coping questionnaire/ survey should be possible to complete in 10-15 minutes.

Table 5. Transition: Feedback points Before Transferring to Adult Services • Suggestion to remove the first bullet point question • Suggestion to re-word bullet point three (3) being informed – do you think you could be informed in a different/ better way (should be: do you think you have been provided enough time)? • Colourful symbols under written, online, and phone options (if questions are to be handed out) • There should be question relating to, do you think there should be a separate clinic for adolescents in an adult environment During the Transfer Process • Suggestion to remove the first bullet point question • To remove one of the two bullet points in this particular section, because they read similar. The one that you select to keep, shorten the question • The question relating to having someone to talk to should be made clearer and again this should be shortened. • There should be a question relating to do what gender professional would you prefer to talk to you about during transition process. After Transition and On-Going Care • All important questions, but need to be shortened • Bullet point (2) should have looking back removed • Bullet point (3) should have sentence removed up until ‘Are you’ Note: The young people informed that any Transition interview questions should be restricted to 20 minutes and this would be best.

Table 6. Coping: Feedback points General • Suggestion made here was to remove the General questions Living and Coping • Living and coping theme should have examples young people can relate to making it easier for them to help provide answers for the researcher, for example school is important, work as well. (Living and Coping theme should replace with Reflecting Back) Family and Friends • This theme should be renamed to communication instead of family and friends – questions are basic and very good, but make points more personal Coping Ways and Planning • This theme should be divided in two - suggest Coping Ways and Planning Coping and Relief • This theme presently reads Coping and Relief (relief is not a sensible word to use). This should be re-worded to Response/ Reaction Note: The young people informed that any Coping interview questions should be restricted to 15 minutes and this would be best in case of any surveys that might also need to be completed.

433

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

Medicine Clinical Research Network (MCRN) Young Persons Advisory Group (YPAG), Great Ormond Street Hospital (GOSH), London: 22nd February 2014 Table 7 and 8 provide feedback points from the MCRN YPAG meeting at GOSH, London based on the questions discussed. Table 7. Transition: Feedback points Before Transferring to Adult Services • Suggestion to remove the first bullet point question • To re-word bullet point three (3) being informed – do you think you could be informed in a different/ better way (should be: do you think you have been provided enough time)? • Do not elaborate on being involved to much because it implies that they are not already in ‘control’ of their care • Some of the questions under this section have been phrased as though young people have been through the transition, so many needs to re-phrased, perhaps in a past tense and providing personal examples. This may help patient researcher get more definite insights and examples • Some of the questions here relate more to after transitioning so, questions need to be under the ‘right’ theme During the Transfer Process • The first bullet point should be restrained to just: Do you feel you were transferred at the tight time? There should not be too late or too soon. Again, it would help if the research used his own experiences – make it more personal • Questions are perhaps too lengthy and just need to be shortened relating more personal experiences – this will be helpful After Transition and On-Going Care • All important questions, but need to be shortened • Bullet point (2) should have looking back removed and should also be an open ended question providing more examples. • Take out question: Is your parent or carer still involved in your care because after they have transitioned, most young people would/ should be driving their own care • Here there should be a question relating to: Was there anything that could be done to prepare you better? This may help the researcher analyse any research from an evaluation perspective Note: Future research relating to transition interview questions should be restricted to 20 minutes and this would be sensible best of the possibility of participants having to complete a potential survey to complement interview-based questions.

Table 8. Coping: Feedback points General • This theme should perhaps be discarded or the questions under it should be amended to something that participants might find more inviting. Living and Coping • Questions under existing Living and coping theme – researcher needs to relate more personal experiences. Again, examples where young people can relate to making it easier for them to help provide answers, for example school is important, work as well. Family and Friends • This theme should be renamed to Support instead of family and friends – questions are basic and very good, but again must make points more personal Coping Ways and Planning • Questions under this theme are really good, but more emphasis to be made on where young people can go for help Coping and Relief • This theme needs to be every day related – this would hopefully make any analysis stronger and more appropriate Note: Future research relating to any coping interview questions should be restricted to 15 minutes and this would be best because of the possibility of participants having to complete a potential survey to complement interview-based questions

434

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

DISCUSSION The insights gathered from the meetings here informed that transition and coping questions needed to be more relevant to Young People with CKD, allowing ‘more personal’ insights. The young people inform that the following points should be considered by future researchers: 1) The ‘rounded experiences’ before, during and after transition of young people with CKD are still required, 2) It is important to see if there is an association between positive coping and smoother transition, 3) Need to appreciate care needs to be better integrated for young people ahead of their transition to achieve best practice and 4) Supporting young people with CKD to build aptitudes is important so they become independent and cope with their health. Integrating transition clinics, coupled with more ‘buddy (or mentoring) systems’, this can help improve young people’s adherence to routine medication as judged by reduced transplant failure rates (Harden et al. 2012). There are different needs and problems in younger vs. adult renal patients (Sawyer et al. 2012). Young people need more support to relieve their health-related complaints, some of which can be extensive in order to cope with negative emotions related to their disease (Darbyshire et al. 2006; Nicholas et al. 2011; Laudanski et al. 2013). Future research should develop such questions that allow information about an association between positive coping and smoother transition to be inferred from the answers. This will also assist future evaluation of services provided to Young People with CKD. A guideline which is addressing specific needs and concerns of YP with CKD should be prompted.

IMPLICATIONS FOR PRACTICE An overall CKD transition guideline to support the process for young people coping with CKD to complement clinical practice is thus needed more so than ever for young people coping with CKD. The Care Quality Commission (CQC, 2014) document can make helpful background reading to further inform a research proposal. An acute transfer from paediatric renal care to adult services is extremely unsettling for young people with CKD, and the need for established transitional services is now being progressively acknowledged, (In press, Nuffield Council of Bioethics, 2015). Future research should also look to involve the Transition Taskforce (Transition Taskforce 2015). There is an on-going need to support and work in partnership in the care of young people with CKD. Young people from all the meetings that took place informed surveys tend to be quite lengthy, however in addition to answering questions, young people informed that any future research should provide an opportunity for participants a choice of self-completing a survey by pen to paper method or online (e.g. Survey Monkey webpage). Participants should also be invited to consent informing of their choice of method for completing a validated measure. If a participant is younger than 18 years of age, then parent/ guardian and young person should be requested to consent/ assent. A guideline should be developed further in collaboration between several paediatric and adult nephrology centres and pilot tested in a small follow-up study.

435

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

CONCLUSION Overall, these meetings were very informative and helped ascertain initial feedback of how the interview questions could be better structured, made ’more personal’ and allowing to ‘provide most ‘relevant’ insight’. The meetings also helped provide context of what would make more effective coping and transition research for the future. It is clear that one-size-fits-all approach does not work for successful coping and transition, and the services provided should meet specific needs and concerns of YP with CKD. Pointing out that it is important to involve young people in developing and reviewing research proposals. (In press, Nuffield Council of Bioethics 2015) inform it is important to involve young people in developing and reviewing research proposals having produced a new Children and Clinical Research guideline to support researchers who seek to identify routes for inclusion of young people in research to ensure services are safe and effective, but also appropriate and acceptable. There is a need for reorganization in transition services to maintain best practice and enhanced care provision for this population (Swallow et al. 2008; Swallow et al. 2012; Swallow et al. 2014). It is important to collect longitudinal coping research data and transition experiences at several dedicated time points in order to ascertain robust conclusions and to help inform future practices. A guideline and reorganization that factors in coping strategies should be prompted in future research for teams supporting the care for young people to maintain best practice.

REFERENCES Ajarmeh, S., Er, L., Brin, G., Djurdjev, O., & Dionne, J. M. (2012). The effect of a multidisciplinary care clinic on the outcomes in pediatric chronic kidney disease. Pediatric Nephrology (Berlin, Germany), 27(10), 1921–1927. doi:10.100700467-012-2209-6 PMID:22669320 Baum, M. (2010). Overview of chronic kidney disease in children. Current Opinion in Pediatrics, 22(2), 158–160. doi:10.1097/MOP.0b013e32833695cb PMID:20299869 Blum, R. W. (1995). Transition to adult health care: Setting the stage. The Journal of Adolescent Health, 17(1), 3–5. doi:10.1016/1054-139X(95)00073-2 PMID:7578159 Blum, R. W., Garell, D., Hodgman, C. H., Jorissen, T. W., Okinow, N. A., Orr, D. P., & Slap, G. B. (1993). Transition from child-centered to adult health-care systems for adolescents with chronic conditions. A position paper of the Society for Adolescent Medicine. J. Adolesc. Health, 14(7), 570–576. doi:10.1016/1054-139X(93)90143-D PMID:8312295 Bowes, G., Sinnema, G., Suris, J. C., & Buhlmann, U. (1995). Transition health services for youth with disabilities: A global perspective. The Journal of Adolescent Health, 17(1), 23–31. doi:10.1016/1054139X(95)00076-5 PMID:7578158 British Association for Paediatric Nephrology. (2011). Improving the Standard of Care in Children with Kidney Disease through Paediatric Nephrology Networks. Retrieved from http://www.rcpch.ac.uk/system/ files/protected/page/Bringing%20Networks%20to%20Life%20for%20web_0.pdf

436

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

British Association of Paediatric Nephrology and Renal Association. (2009). Helping Adolescents and Young Adults with End-Stage Renal Disease. Retrieved from http://www.bapn.org/assets/clinical_standards/BAPN%20RA%20transition%20document.pdf Care Quality Commission (CQC). (2014, June). From the Pond into Sea: Children’s Transition to Adult Health Services. Retrieved from https://www.cqc.org.uk/sites/default/files/CQC_Transition%20Report.pdf Chaturvedi, S., Jones, C. L., Walker, R. G., & Sawyer, S. M. (2009). The transition of kidney transplant recipients: A work in progress. Pediatric Nephrology (Berlin, Germany), 24(5), 1055–1060. doi:10.100700467-009-1124-y PMID:19238453 Darbyshire, P., Oster, C., & Henning, P. (2006). Children’s and young people’s experiences of chronic renal disease: A review of the literature, methodological commentary and an alternative proposal. Journal of Clinical Nursing, 15(6), 751–760. doi:10.1111/j.1365-2702.2006.01510.x PMID:16684171 De Ridder, D., & Schreurs, K. (1996). Coping, social support and chronic disease: A research agenda. Psychology Health and Medicine, 1(1), 71–82. doi:10.1080/13548509608400007 Department of Health. (2006b). Transition: getting it right for young people - Improving the transition of young people with long term conditions from children’s to adult health services. Retrieved from https://www.bspar.org.uk/DocStore/FileLibrary/PDFs/Transition-%20getting%20it%20right%20for%20 young%20people%20-%2023rd%20March%202006.pdf Eiser, C., Cotter, I., Oades, P., Seamark, D., & Smith, R. (1999). Health-related quality-of-life measures for children. International Journal of Cancer. Supplement, 83(S12), 87–90. doi:10.1002/(SICI)10970215(1999)83:12+3.0.CO;2-O PMID:10679877 Eiser, C., & Jenney, M. (2007). Measuring quality of life. Archives of Disease in Childhood, 92(4), 348–350. doi:10.1136/adc.2005.086405 PMID:17376942 Eiser, C., & Morse, R. (2001). A review of measures of quality of life for children with chronic illness. Archives of Disease in Childhood, 84(3), 205–211. doi:10.1136/adc.84.3.205 PMID:11207164 Fogo, A. B. (2007). Mechanisms of progression of chronic kidney disease. Pediatric Nephrology (Berlin, Germany), 22(12), 2011–2022. doi:10.100700467-007-0524-0 PMID:17647026 Folkman, S. (2008). The case for positive emotions in the stress process. Anxiety, Stress, and Coping, 21(1), 3–14. doi:10.1080/10615800701740457 PMID:18027121 Folkman, S. (2010). Stress, coping, and hope. Psycho-Oncology, 19(9), 901–908. doi:10.1002/pon.1836 PMID:20799373 Folkman, S., & Moskowitz, J. T. (2004). Coping: Pitfalls and promise. Annual Review of Psychology, 55(1), 745–774. doi:10.1146/annurev.psych.55.090902.141456 PMID:14744233 Fowler, C., & Baas, L. S. (2006). Illness representations in patients with chronic kidney disease on maintenance hemodialysis. Nephrology Nursing Journal, 33(2), 173–174. PMID:16613412

437

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

Freed, G. L., & Hudson, E. J. (2006). Transitioning children with chronic diseases to adult care: Current knowledge, practices, and directions. The Journal of Pediatrics, 148(6), 824–827. doi:10.1016/j. jpeds.2006.02.010 PMID:16769396 Giarelli, E., Bernhardt, B. A., Mack, R., & Pyeritz, R. E. (2008). Adolescents’ transition to self-management of a chronic genetic disorder. Qualitative Health Research, 18(4), 441–457. doi:10.1177/1049732308314853 PMID:18354044 Goldstein, S. L., Graham, N., Warady, B. A., Seikaly, M., McDonald, R., Burwinkle, T. M., ... Varni, J. W. (2008). Measuring health-related quality of life in children with ESRD: Performance of the generic and ESRD-specific instrument of the Pediatric Quality of Life Inventory (PedsQL). American Journal of Kidney Diseases, 51(2), 285–297. doi:10.1053/j.ajkd.2007.09.021 PMID:18215706 Goldstein, S. L., Rosburg, N. M., Warady, B. A., Seikaly, M., McDonald, R., Limbers, C., & Varni, J. W. (2009). Pediatric end stage renal disease health-related quality of life differs by modality: A PedsQL ESRD analysis. Pediatric Nephrology (Berlin, Germany), 24(8), 1553–1560. doi:10.100700467-0091174-1 PMID:19421787 Harden, P. N., Walsh, G., Bandler, N., Bradley, S., Lonsdale, D., Taylor, J., & Marks, S. D. (2012). Bridging the gap: An integrated paediatric to adult clinical service for young adults with kidney failure. BMJ (Clinical Research Ed.), 344, e3718. PMID:22661725 Hartzler, A., & Pratt, W. (2011). Managing the personal side of health: How patient expertise differs from the expertise of clinicians. Journal of Medical Internet Research, 13(3), e62. doi:10.2196/jmir.1728 PMID:21846635 Harwood, L., Wilson, B., Locking-Cusolito, H., Sontrop, J., & Spittal, J. (2009). Stressors and coping in individuals with chronic kidney disease. Nephrology Nursing Journal, 36(3), 265–276, 301. PMID:19588694 Huh, J., & Ackerman, M. S. (2012a). Collaborative Help in Chronic Disease Management: Supporting Individualized Problems. Proceedings of CSCW 2012 (pp. 853–862). PMID:25360442 Huh, J., Hartzler, A., Munson, S., Anderson, N., Edwards, K., Gore, J.L., McDonald, D., O’Leary, J., Parker, A., Streat, D., Yetisgen-Yildiz, M., Pratt, W., & Ackerman, M.S. (2012b). Brainstorming Design for Health: Helping Patients Utilize Patient-Generated Information on the Web. Proceedings of the conference on computer-supported cooperative work CSCW 2012 (pp. 11-12). Huh, J., McDonald, D. W., Hartzler, A., & Pratt, W. (2013a). Patient moderator interaction in online health communities. AMIA Annual Symposium Proceedings 2013 (pp. 627–636). PMID:24551364 Huh, J., Patel, R., & Pratt, W. (2012c). Tackling Dilemmas in Supporting “The Whole Person” in Online Patient Communities. Proc. SIGCHI. Conf. Hum. Factor Comput. Syst. 2012 (pp. 923-926). Huh, J., Yetisgen-Yildiz, M., & Pratt, W. (2013b). Text classification for assisting moderators in online health communities. Journal of Biomedical Informatics, 46(6), 998–1005. doi:10.1016/j.jbi.2013.08.011 PMID:24025513

438

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

INVOLVE. (2012). Strategies for Diversity and Inclusion in Public Involvement: Supplement to the briefing notes for researchers. Retrieved from http://www.invo.org.uk/wp-content/uploads/2014/10/ INVOLVE_Inclusion_Supplement_links-updated-July-2014-WEB.pdf INVOLVE. (2015). Retrieved from http://www.invo.org.uk/ Kaltsouda A, Skapinakis P, Damigos D, Ikonomou M, Kalaitzidis R, Mavreas V, Siamopoulos K.C. (2011). Defensive coping and health-related quality of life in chronic kidney disease: a cross-sectional study. BMC Nephrology, 12(1), 28. Kennedy, A., Sloman, F., Douglass, J. A., & Sawyer, S. M. (2007). Young people with chronic illness: The approach to transition. Internal Medicine Journal, 37(8), 555–560. doi:10.1111/j.1445-5994.2007.01440.x PMID:17640188 Lauda. (2013). Age-related differences in the quality of life in end-stage renal disease in patients enrolled in hemodialysis or continuous peritoneal dialysis. Medical Science Monitor, 19, 378–385. doi:10.12659/ MSM.883916 PMID:23685340 Lazarus, R. S. (1985). The psychology of stress and coping. Issues in Mental Health Nursing, 7(1-4), 399–418. doi:10.3109/01612848509009463 PMID:3854019 Lazarus, R. S. (1993a). Coping theory and research: Past, present, and future. Psychosomatic Medicine, 55(3), 234–247. doi:10.1097/00006842-199305000-00002 PMID:8346332 Lazarus, R. S. (1993b). From psychological stress to the emotions: A history of changing outlooks. Annual Review of Psychology, 44(1), 1–22. doi:10.1146/annurev.ps.44.020193.000245 PMID:8434890 Lazarus, R. S., & Folkman, S. (1984). Stress, Appraisal and Coping. New York: Springer. Lewis, M. A., Shaw, J., Sinha, M. D., Adalat, S., Hussain, F., & Castledine, C. van Schalkwyk D., & Inward, C. (2010). UK Renal Registry 12th Annual Report: Chapter 14: Demography of the UK paediatric renal replacement therapy population in 2008. Nephron Clinical Practice, 115(Suppl. 1), c279-c288. Lindqvist, R., Carlsson, M., & Sjoden, P. O. (1998a). Coping strategies and quality of life among patients on hemodialysis and continuous ambulatory peritoneal dialysis. Scandinavian Journal of Caring Sciences, 12(4), 223–230. doi:10.1111/j.1471-6712.1998.tb00501.x PMID:10067648 Lindqvist, R., Carlsson, M., & Sjoden, P. O. (2004). Coping strategies of people with kidney transplants. Journal of Advanced Nursing, 45(1), 47–52. doi:10.1046/j.1365-2648.2003.02859.x PMID:14675300 Lindqvist, R., & Sjoden, P. O. (1998b). Coping strategies and quality of life among patients on continuous ambulatory peritoneal dialysis (CAPD). Journal of Advanced Nursing, 27(2), 312–319. doi:10.1046/j.13652648.1998.00523.x PMID:9515641 Maes, S., Leventhal, H., & de Ridder, D. T. D. (1996). Coping with chronic diseases. In M. Zeidner & N. Endler (Eds.), Handbook of Coping: Theory, Research and Applications (pp. 221–251). New York: Wiley.

439

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

Marciano, R. C., Bouissou Soares, C. M., Diniz, J. S. S., Lima, E. M., Silva, J. M. P., Canhestro, M. R., ... Oliveira, E. A. (2011). Behavioral disorders and low quality of life in children and adolescents with chronic kidney disease. Pediatric Nephrology (Berlin, Germany), 26(2), 281–290. doi:10.100700467010-1683-y PMID:21110044 McDonagh, J. E. (2007). Transition of care from paediatric to adult rheumatology. Archives of Disease in Childhood, 92(9), 802–807. doi:10.1136/adc.2006.103796 PMID:17715444 McDonagh, J. E. (2013). Has the gap been bridged yet? Young people in paediatric and adult rheumatology. Rheumatology (Oxford, England), 52(8), 1349–1351. doi:10.1093/rheumatology/kes407 PMID:23353646 McDonald, S. P., & Craig, J. C. (2004). Long-term survival of children with end-stage renal disease. The New England Journal of Medicine, 350(26), 2654–2662. doi:10.1056/NEJMoa031643 PMID:15215481 Moos, R. H., & Schaeffer, J. A. (1984). The crisis of physical illness. An overview and conceptual approach. In R.M. Moss (Ed.), Coping With Physical Illness (Vol. 2, pp. 3–39). New York: Plenum Press. doi:10.1007/978-1-4684-4772-9_1 Muhammad, S., Banks, P., & Martin, C. (2012a). Coping: is this the foundation of wellbeing? A narrative review. British Journal of Mental Health Nursing, 1(4). Muhammad, S., Milford, D. V., Carson, A., Young, H., & Martin, C. R. (2015). COPING IN YOUNG PEOPLE WITH CHRONIC KIDNEY DISEASE (CKD). Journal of Renal Care, n/a. doi:10.1111/ jorc.12131 PMID:26041710 Muhammad, S., Noble, H., Banks, P., Carson, A., & Martin, R. C. (2012b). How Young People Cope with Chronic Kidney Disease: Literature Review. Journal of Renal Care, 38(4), 182–190. doi:10.1111/j.17556686.2012.00324.x PMID:23176577 Murphy, F., Jenkins, K., Chamney, M., McCann, M., & Sedgewick, J. (2008a). CE: Continuing Education article. Patient management in CKD stages 1 TO 3. Journal of Renal Care, 34(3), 127–135. doi:10.1111/j.1755-6686.2008.00029.x PMID:18786079 Murphy, F., Jenkins, K., McCann, M., & Sedgewick, J. (2008b). CE: Continuing Education article. Patient management in chronic kidney disease stages 4 to 5. Journal of Renal Care, 34(4), 191–198. doi:10.1111/j.1755-6686.2008.00042.x PMID:19090897 Myers, P. S. (2002). Transitioning an adolescent dialysis patient to adult health care. Nephrology Nursing Journal, 29(4), 375–376. PMID:12224372 Nicholas, D. B., Picone, G., & Selkirk, E. K. (2011). The lived experiences of children and adolescents with end-stage renal disease. Qualitative Health Research, 21(2), 162–173. doi:10.1177/1049732310382789 PMID:20833832 Nuffield Council on Bioethics Report. (2015). Children and Clinical Research, Ethical Issues (available at http://nuffieldbioethics.org/wp-content/uploads/Children-and-clinical-research-full-report.pdf) (In press)

440

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

Park, K. S., Hwang, Y. J., Cho, M. H., Ko, C. W., Ha, I. S., Kang, H. G., ... Cho, H. Y. (2012). Quality of life in children with end-stage renal disease based on a PedsQL ESRD module. Pediatric Nephrology (Berlin, Germany), 27(12), 2293–2300. doi:10.100700467-012-2262-1 PMID:22832667 Prainsack, B. (2014). The powers of participatory medicine. PLoS Biology, 12(4), e1001837. doi:10.1371/ journal.pbio.1001837 PMID:24736935 Renal Registry. (2012). Demography of the UK Paediatric Renal Replacement Therapy Population in 2012. Retrieved from http://www.renalreg.com/Report-Area/Report%202013/07-Chap-07.pdf Reinfjell, T., Diseth, T. H., Veenstra, M., & Vikan, A. (2006). Measuring health-related quality of life in young adolescents: Reliability and validity in the Norwegian version of the Pediatric Quality of Life Inventory 4.0 (PedsQL) generic core scales. Health and Quality of Life Outcomes, 4(1), 61. doi:10.1186/1477-7525-4-61 PMID:16972987 Renkema, K. Y., Winyard, P. J., Skovorodkin, I. N., Levtchenko, E., Hindryckx, A., Jeanpierre, C., ... Bongers, E. M. (2011). Novel perspectives for investigating congenital anomalies of the kidney and urinary tract (CAKUT). Nephrology, Dialysis, Transplantation, 26(12), 3843–3851. doi:10.1093/ndt/ gfr655 PMID:22121240 Department of Health. (2011). You’re Welcome - Quality criteria for young people friendly health services. London. Retrieved from https://www.gov.uk/government/uploads/system/uploads/attachment_data/ file/216350/dh_127632.pdf Reynolds, J. M., Garralda, M. E., Jameson, R. A., & Postlethwaite, R. J. (1986). Living with chronic renal failure. Child: Care, Health and Development, 12(6), 401–407. doi:10.1111/j.1365-2214.1986. tb00517.x PMID:3815752 Roder, I., & Boekaerts, M. (1999). Stress, coping, and adjustment in children with a chronic disease: A review of the literature. Disability and Rehabilitation, 21(7), 311–337. doi:10.1080/096382899297576 PMID:10471163 Rosen, D. S., Blum, R. W., Britto, M., Sawyer, S. M., & Siegel, D. M. (2003). Transition to adult health care for adolescents and young adults with chronic conditions: Position paper of the Society for Adolescent Medicine. The Journal of Adolescent Health, 33(4), 309–311. doi:10.1016/S1054-139X(03)00208-8 PMID:14519573 Sawyer, S. M., Afifi, R. A., Bearinger, L. H., Blakemore, S. J., Dick, B., Ezeh, A. C., & Patton, G. C. (2012). Adolescence: A foundation for future health. Lancet, 379(9826), 1630–1640. doi:10.1016/ S0140-6736(12)60072-5 PMID:22538178 Scal, P. (2002). Transition for youth with chronic conditions: Primary care physicians’ approaches. Pediatrics, 110(6 Pt 2), 1315–1321. PMID:12456951 Scal, P., & Ireland, M. (2005). Addressing transition to adult health care for adolescents with special health care needs. Pediatrics, 115(6), 1607–1612. doi:10.1542/peds.2004-0458 PMID:15930223

441

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

Silkensen, J. R. (2000). Long-term complications in renal transplantation. Journal of the American Society of Nephrology, 11(3), 582–588. PMID:10703683 Swallow, V., Forrester, T., & Macfadyen, A. (2012). Teenagers’ and parents’ views on a short-break service for children with life-limiting conditions: A qualitative study. Palliative Medicine, 26(3), 257–267. doi:10.1177/0269216311401947 PMID:21474621 Swallow, V., Lambert, H., Clarke, C., Campbell, S., & Jacoby, A. (2008). Childhood chronic-kidneydisease: A longitudinal-qualitative study of families learning to share management early in the trajectory. Patient Education and Counseling, 73(2), 354–362. doi:10.1016/j.pec.2008.07.052 PMID:18799284 Swallow VM, Hall AG, Carolan I, Santacroce S, Webb NJ, Smith T, Hanif N. (2014). Designing a webapplication to support home-based care of childhood CKD stages 3-5: qualitative study of family and professional preferences. BMC Nephrology, 2014(15), 34. TransitionTaskforce. (2015). Retrieved from http://www.togetherforshortlives.org.uk/professionals/ projects/the_transition_taskforce The National Service Framework for Renal Services. (2006a). Working for Children and Young People Department of Health. Retrieved from http://webarchive.nationalarchives.gov.uk/20130107105354/ http://www.dh.gov.uk/prod_consum_dh/groups/dh_digitalassets/@dh/@en/documents/digitalasset/ dh_4136542.pdf University Hospital, Southampton. (2014). Ready Steady Go Transition Survey. Retrieved from www. uhs.nhs.uk/readysteadygo Van der Heijden, B. J., van Dijk, P. C., Verrier-Jones, K., Jager, K. J., & Briggs, J. D. (2004). Renal replacement therapy in children: Data from 12 registries in Europe. Pediatric Nephrology (Berlin, Germany), 19(2), 213–221. doi:10.100700467-003-1376-x PMID:14685843 Walsh, J., Moore, C., Swain, D., & Sizmur, S. (2012). Shared-Decision Making, Picker Institute, Europe. Retrieved from http://www.pickereurope.org/wp-content/uploads/2014/10/Shared-Decision-Making...NHS-East-Midlands.pdf Watson, A. R. (1996). Chronic renal failure in childhood. British Journal of Hospital Medicine, 55(6), 329–331. PMID:8696626 Watson, A. R. (2000). Non-compliance and transfer from paediatric to adult transplant unit. Pediatric Nephrology (Berlin, Germany), 14(6), 469–472. doi:10.1007004670050794 PMID:10872185 Watson, A. R. (2005). Problems and pitfalls of transition from paediatric to adult renal care. Pediatric Nephrology (Berlin, Germany), 20(2), 113–117. doi:10.100700467-004-1763-y PMID:15627164 Watson, A. R., Harden, P., Ferris, M., Kerr, P. G., Mahan, J., & Ramzy, M. F. (2011). Transition from pediatric to adult renal services: A consensus statement by the International Society of Nephrology (ISN) and the International Pediatric Nephrology Association (IPNA). Pediatric Nephrology (Berlin, Germany), 26(10), 1753–1757. doi:10.100700467-011-1981-z PMID:21842231

442

 Coping and Transition in Young People With Chronic Kidney Disease (CKD)

Webb, N., Harden, P., Lewis, C., Tizzard, S., Walsh, G., Wray, J., & Watson, A. (2010). Building consensus on transition of transplant patients from paediatric to adult healthcare. Archives of Disease in Childhood, 95(8), 606–611. doi:10.1136/adc.2009.176255 PMID:20515964 Whitehouse, S., & Paone, M. (1998). Patients in transition: Bridging the health care gap from youth to adulthood. Contemporary Pediatrics, 13, 15–16. Zautra, A. J. (1996). Investigations of the ongoing stressful situations among those with chronic illness. American Journal of Community Psychology, 24(6), 697–717. doi:10.1007/BF02511031 PMID:9194327

This research was previously published in the International Journal of User-Driven Healthcare (IJUDH), 5(1); edited by Ashok Kumar Biswas, pages 30-46, copyright year 2015 by IGI Publishing (an imprint of IGI Global).

443

Section 8

Mental Illness

445

Chapter 22

Global Burden of Mental Disorders:

Quality of Care and Unmet Needs for Treatment of Chronic Mental Illness Meghamala S. Tavaragi DIMHANS, India Sushma C. DIMHANS, India

ABSTRACT Mental disorders are an important cause of long-term disability and dependency. It accounts for over 15% of the disease burden in developed countries, which is more than the disease burden caused by all cancers. Mental illness is a leading cause of suffering, economic loss and social problems. The burden of mental disorders is likely to have been underestimated because of inadequate appreciation of the connectedness between mental illness and other health conditions. Mental disorders increase risk for communicable and non-communicable diseases, and contribute to unintentional and intentional injury, and comorbidity complicates help-seeking, diagnosis, and treatment, and influences prognosis. Consequently, health professionals have trivialized the issue of mental illness. It is essential that researchers and public health professionals work together to resolve the enormous public health crisis presented by mental disorders. In short, we must “mainstream” mental health.

INTRODUCTION The WHO proposition that there can be “no health without mental health” has also been endorsed by the Pan American Health Organization, the EU Council of Ministers, the World Federation of Mental Health, and the UK Royal College of Psychiatrists. Mental disorders are an important cause of long-term disability and dependency. Mental health is more than the mere lack of mental disorders. The positive dimension of mental health is stressed in WHO’s definition of health as contained in its constitution: DOI: 10.4018/978-1-5225-7122-3.ch022

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Global Burden of Mental Disorders

“Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity.” Concepts of mental health include subjective well-being, perceived self-efficacy, autonomy, competence, intergenerational dependence and recognition of the ability to realize one’s intellectual and emotional potential. It has also been defined as a state of well-being whereby individuals recognize their abilities, are able to cope with the normal stresses of life, work productively and fruitfully, and make a contribution to their communities. Mental health is about enhancing competencies of individuals and communities and enabling them to achieve their self-determined goals. Mental health should be a concern for all of us, rather than only for those who suffer from a mental disorder (World Health Organization [WHO], 2003).

DEFINING CHRONIC MENTAL ILLNESS 1. Who Is Chronically Ill? Individuals who, through no fault of their own or their families, suffer from one of several diseases affecting the brain, the most complex of human organs. The causes remain unknown, but are probably multiple. There is no cure, but we do have effective treatment. In addition to having a brain disease, people with chronic mental illness (serious mental illness) are (by definition) significantly functionally impaired by the illness for an indefinite period of time (diagnosis, disability, duration). At least 1% of the population are chronic mentally ill. The problems of victims and their families are compounded by stigma, one of the cruellest and most prevalent forms of bigotry that exists. •

•

446

Symptoms of Chronic Mental Illness: Acute, “positive” symptoms (at least one of these usually present, at least during an exacerbation of illness): ◦◦ Distorted perceptions; loss of contact with reality; ▪▪ Delusions. ▪▪ Hallucinations. ◦◦ Disordered, disorganized and confused thinking. ◦◦ Unstable and inappropriate emotions. ◦◦ Bizarre behavior; impaired judgment. Residual (“negative”) or deficit symptoms (several of these usually present most of the time): ◦◦ Vulnerability to certain kinds of stress. ◦◦ Extreme dependency (sometimes combined with hostility). ◦◦ Difficulty with interpersonal relationships. ◦◦ Deficient coping skills. ◦◦ Poor transfer of learning; fear of new situations. ◦◦ Restricted emotional response and lack of enjoyment. ◦◦ Reduced speech and impaired abstract thinking. ◦◦ Reduced ability to pay attention; slowness. ◦◦ Apathy; lack of motivation; phobic avoidance of situations. ◦◦ Sensitivity to over- (and under-) stimulation (Goldman, 1998).

 Global Burden of Mental Disorders

•

•

“Normal” Reactions to Chronic Illness: These reactions are common in anyone who realizes they have a serious, chronic (incurable) illness, and may progress through stages (like the mourning process). Some of these characteristics are often present and can be mis-diagnosed as positive or negative symptoms. ◦◦ General stress response (“fight, flight, fright”). ◦◦ Grief; denial and impatience (lack of acceptance). ◦◦ Anger and striking out. ◦◦ Guilt and self-blame. ◦◦ Depression; hopeless, helpless feelings; demoralization. ◦◦ Regression to earlier levels of functioning. ◦◦ Preoccupation with “self” (apparent disinterest in others). ◦◦ Interruption of normal development (immaturity). Social Breakdown Syndrome: This includes loss of normal role functioning and varying degrees of extrusion (or exclusion) from normal family/community functioning. Characteristics are similar to the negative symptoms of chronic mental illness and also resemble institutionalization syndrome. Social breakdown syndrome can be a side effect of any treatment that removes the client/patient from his/her usual social environment (or excuses him from usual role expectations) (e.g., prolonged hospitalization or too much “overprotection” on the part of clinical staff and/or family members) (Goldman, 1998).

2. Chronically Mentally Ill Law and Legal Definition Chronically mentally ill is a term used to describe a major mental disorder based on a diagnosis by a licensed medical health professional which shows that such a person has serious problems in the areas of work, family and also has frequent variations in his/her thinking or mood. The following is an example of a federal statute defining chronically mentally ill. “Chronically mentally ill means a condition of schizophrenia or major affective disorder or post-traumatic stress disorder (PTSD), based on a diagnosis from a licensed mental health professional, with at least one documented hospitalization for this condition sometime in the last 2 years or with documentation of a formal assessment on a standardized scale of any serious symptomology or serious impairment in the areas of work, family relations, thinking, or mood.”

3. Chronic Mental Illness Is Difficult to Define Before deinstitutionalization, the criterion for chronicity was current or prior hospitalization (Bachrach, 1988). Present definitions emphasize three criteria: duration, diagnosis, and disability (Bachrach, 1988). • •

First, chronic illness is distinguished by its gradual onset, indefinite duration, threat of relapse, and lack of return to prodromal functioning. Acute illness, in contrast, has an abrupt onset and finite duration (Anderson, cited in Wintersteen,1986). The second criterion is diagnosis, which is made on the basis of psychiatric symptoms, such as depressed mood, hallucinations, or delusions. A diagnosis of schizophrenia implies chronicity, almost by definition, because of its generally poor prognosis.

447

 Global Burden of Mental Disorders

•

The third criterion is disability. In addition to the severe psychiatric symptoms suffered in CMI, secondary disabilities are also present that lead to considerable financial, social, vocational, and personal impairment (Gregory, Andrew, Ryan, & Stephanie, 1993).

Because CMI is characterized by chronic deficits in personal and social functioning, many people with CMI are unable to perform the basic activities of daily living. Many are unemployed, are dependent on welfare services for survival, and lack adequate health care. In addition, the chronically mentally ill must also deal with stigma and discrimination. These factors combine to make them “one of the most needy and disadvantaged groups of society” (Shadish, Lurigio, & Lewis, 1989).

4. “Chronically Mentally Ill Adult” or “Adult Who Is Chronically Mentally Ill” This means an adult who has a mental disorder and meets at least one of the following criteria: 1. Has undergone two or more episodes of hospital care for a mental disorder within the preceding two years; or 2. Has experienced a continuous psychiatric hospitalization or residential treatment exceeding six months’ duration within the preceding year; 3. Has been unable to engage in any substantial gainful activity by reason of any mental disorder which has lasted for a continuous period of not less than twelve months. “Substantial gainful activity” shall be defined by the department by rule consistent with Public Law 92-603, as amended (Washington state legislature Definitions, Effective until, 2016).

GLOBAL BURDEN OF MENTAL DISORDERS Mental disorders make a substantial independent contribution to the burden of disease worldwide (WHO, 1992 - 94). WHO’s 2005 estimates of the global burden of disease provide evidence on the relative effect of health problems worldwide (Murray, & Lopez, 1996,&Mathers & Loncar 2006).Noncommunicable diseases are rapidly becoming the dominant causes of ill health in all developing regions except sub-Saharan Africa (Mathers,& Loncar, 2006).The Global Burden of Disease report has revealed the scale of the contribution of mental disorders, by use of an integrated measure of disease burden, the disability-adjusted life-year, which is the sum of years lived with disability and years of life lost (Mathers, & Loncar, 2006).The report showed that neuropsychiatric conditions account for up to a quarter of all disability-adjusted life-years, and up to a third of those attributed to non-communicable diseases, although the size of this contribution varies between countries according to income level (Mathers, & Loncar, 2006).The neuropsychiatric conditions that contribute the most disability-adjusted life-years are mental disorders, especially unipolar and bipolar affective disorders, substance-use and alcohol-use disorders, schizophrenia, and dementia. Neurological disorders (such as migraine, epilepsy, Parkinson’s disease, and multiple sclerosis) make a smaller but still significant contribution. Of the non-communicable diseases, neuropsychiatric conditions contribute the most to overall burden (Mathers & Loncar, 2006) more than either cardiovascular disease or cancer. Mental disorders are an important cause of long-term disability and dependency. WHO’s 2005 report attributed 31.7% of all years lived-with-disability to neuropsychiatric conditions: the five major contribu448

 Global Burden of Mental Disorders

tors to this total were unipolar depression (11.8%), alcohol-use disorder (3.3%), schizophrenia (2.8%), bipolar depression (2.4%), and dementia (1.6%) (Mathers & Loncar, 2006). However, the interaction between mental disorder and disability is more complex and extensive than the WHO report suggests. Only 40 000 deaths were attributed to mental disorders (mainly unipolar and bipolar depression, schizophrenia, and post-traumatic stress disorder) and 182 000 to use of drugs and alcohol (Mathers & Loncar, 2006).These numbers are almost certainly underestimated, since the report attributes death by suicide to intentional injury(Mathers & Loncar, 2006).Every year, about 800 000 people commit suicide, 86% of whom are in low-income and middle-income countries, and more than half of whom are aged between 15 and 44 years. Even these figures might be under-estimated, since official statistics in low-income and middle-income countries are not reliable. For example, studies in south India that used surveillance with validated verbal autopsy showed that rates of suicide were ten times greater than the official national estimates (Aaron, Joseph, & Abraham, 2004; Prasad, Abraham, & Minz, 2006), that suicide was the leading cause of death in 10–19 year olds; and that suicides accounted for a quarter of all deaths in boys and up to three-quarters of all deaths in young women (Aaron, Joseph, & Abraham, 2004).A systematic review of psychological autopsy case-control studies identified mental disorders (depression, schizophrenia and other psychoses, and alcohol-use and substance-use disorders) as important proximal risk factors for suicide, with a median prevalence of mental disorder of 91% in suicide completers, and a population-attributable fraction of 47–74% (Cavanagh, Carson, Sharpe, & Lawrie, 2003).Findings from psychological autopsy studies in India and China were similar (Vijayakumar & Rajkumar, 1999; Phillips et al., 2002).Therefore, prevention, identification, and appropriate management of mental health problems is an important element of suicide prevention. The burden of mental disorders is likely to have been underestimated because of inadequate appreciation of the connectedness between mental illness and other health conditions. Because these interactions are protean, there can be no health without mental health. Mental disorders increase risk for communicable and non-communicable diseases, and contribute to unintentional and intentional injury. Conversely, many health conditions increase the risk for mental disorder, and comorbidity complicates help-seeking, diagnosis, and treatment, and influences prognosis. Health services are not provided equitably to people with mental disorders, and the quality of care for both mental and physical health conditions for these people could be improved. As many as 450 million people worldwide are estimated to be suffering at any given time from some kind of mental or brain disorder, including behavioural and substance abuse disorders. In the World Health Report 2001 that we devote to mental health, we bring updated figures which show that four of the ten leading causes of disability worldwide are neuropsychiatric disorders, accounting for 30.8% of total disability and 12.3% of the total burden of disease. This latter figure is expected to rise to 15% by the year 2020 (Ministerial Round Tables, 2001). The 1990 WHO report indicated that 5 of the 10 leading causes of disability were psychiatric conditions. Psychiatric and neurologic conditions account for 28% of all years lived with disability, but only 1.4% of all deaths and 1.1% of years of life lost. Thus, psychiatric disorders, while traditionally not regarded as a major epidemiological problem, are shown by consideration of disability years to have a huge impact on populations. Today, about 450 million people suffer from a mental or behavioural disorder. According to WHO’s Global Burden of Disease 2001, 33% of the years lived with disability (YLD) are due to neuropsychiatric disorders, a further 2.1% to intentional injuries. Unipolar depressive disorders alone lead to 12.15% of years lived with disability, and rank as the third leading contributor to the global burden of diseases. Four of the six leading causes of years lived with disability are due to neuropsychiatric disorders (depression, alcohol-use disorders, schizophrenia and bipolar disorder). Neuropsychiatric conditions account 449

 Global Burden of Mental Disorders

for 13% of disability adjusted life years (DALYs), intentional injuries form 3.3% and HIV/AIDS for another 6%. These latter two have a behavioural component linked to mental health. Moreover, behind these oft-repeated figures lies enormous human suffering. • • • • •

More than 150 million persons suffer from depression at any point in time; Nearly 1 million commit suicide every year; About 25 million suffer from schizophrenia; 38 million suffer from epilepsy; and More than 90 million suffer from an alcohol- or drug-use disorder.

The number of individuals with disorders is likely to increase further in view of the ageing of the population, worsening social problems and civil unrest. This growing burden amounts to a huge cost in terms of human misery, disability and economic loss (WHO, 2003) • • • •

As many as 450 million people suffer from a mental or behavioural disorder. Nearly 1 million people commit suicide every year. Four of the six leading causes of years lived with disability are due to neuropsychiatric disorders (depression, alcohol-use disorders, schizophrenia and bipolar disorder). One in four families has at least one member with a mental disorder. Family members are often the primary caregivers of people with mental disorders. The extent of the burden of mental disorders on family members is difficult to assess and quantify, and is consequently often ignored. However, it does have a significant impact on the family’s quality of life.In addition to the health and social costs, those suffering from mental illnesses are also victims of human rights violations, stigma and discrimination, both inside and outside psychiatric institutions (WHO, 2003). Mental illness is a leading cause of suffering, economic loss and social problems. It accounts for over 15% of the disease burden in developed countries, which is more than the disease burden caused by all cancers (Prince et al., 2007). In the EU at least 83 million people (27%) suffer from mental health problems (16.7 million in the UK) (Wittchen & Jacobi, 2005). The most common mental health problem is depression which is experienced by 8–12% of the adult population (Ustun, Ayuso– Mateos, Chatterji, Mathers, & Murray, 2004). In addition, about 10% (nearly 850,000) of children and young people aged between 5–16 years have mental health problems (Green, McGinnity, Meltzer, Ford, & Goodman, 2005).

BURDEN OF SPECIFIC MENTAL ILLNESS Depression •

450

According to the World Health Organization, unipolar depression was the third most important cause of disease burden worldwide in 2004. Unipolar depression was in “eighth place in lowincome countries, but at first place in middle- and high-income countries” (WHO, 2008).

 Global Burden of Mental Disorders

• • •

In a nationally representative face-to-face household survey, 6.7% of U.S. adults experienced a major depressive episode in the past 12 months (Kessler, Chiu, Demler, Merikangas, & Walters, 2005). Significantly greater percentages of lifetime major depression have been reported among women (11.7%) than men (5.6%) (Ford, & Erlinger, 2004). Examining ethnic differences reveals lifetime percentages of depression of 6.52% among whites and 4.57% among blacks and 5.17% among Hispanics (Oquendo, Lizardi, Greenwald, Weismann, & Mann, 2004).

Anxiety • • • • •

Anxiety disorders, which include panic disorder, generalized anxiety disorder, post-traumatic stress disorder, phobias, and separation anxiety disorder, are the most common class of mental disorders present in the general population (Kessler et al., 2009). The estimated lifetime prevalence of any anxiety disorder is over 15%, while the 12-month prevalence is more than 10% (Kessler et al., 2009). Prevalence estimates of anxiety disorders are generally higher in developed countries than in developing countries (Kessler, Aguilar-Gaxiola., & Philip, 2009). Most anxiety disorders are more prevalent in women than in men (McLean, Asnaani, Litz, & Hofmann, 2011). One study estimated the annual cost of anxiety disorders in the United States to be approximately $42.3 billion in the 1990s, a majority of which was due to non-psychiatric medical treatment costs. This estimate focused on short-term effects and did not include the effect of outcomes such as the increased risk of other disorders (Greenberg et al., 1999).

Bipolar Disorder •

•

• •

The National Comorbidity Study reported a lifetime prevalence of nearly 4% for bipolar disorder. Bipolar disorder is more common in women than men, with a ratio of approximately 3:2. The median age of onset for bipolar disorder is 25 years, with men having an earlier age of onset than women (Andreasen & Black, 2006). In an insured population, 7.5% of all claimants with behavioral health care coverage filed a claim, of which 3.0% had bipolar disorder (Peele, Xu, &Kupfer, 2003). Persons with bipolar disorder incurred $568 in annual out-of-pocket expenses—more than double the expenses incurred by all claimants. Annual insurance payments were greater for medical services for persons with bipolar disorder than for patients with other behavioral healthcare diagnoses (Peele, Xu, &Kupfer, 2003). The inpatient hospitalization rate of bipolar patients (39.1%) was greater than the 4.5% characterizing all other patients with behavioral health care diagnoses. Bipolar disorder has been deemed the most expensive behavioral health care diagnosis (Peele, Xu, & Kupfer, 2003), costing more than twice as much as depression per affected individual (Laxman, Lovibond, & Hassan, 2008). Total costs largely arise from indirect costs and are attributable to lost productivity, in turn arising from absenteeism and presenteeism (Laxman & Hassan, 2008).

451

 Global Burden of Mental Disorders

•

For every dollar allocated to outpatient care for persons with bipolar disorder, $1.80 is spent on inpatient care, suggesting early intervention and improved prevention management could decrease the financial impact of this illness (Peele & Kupfer, 2003).

Schizophrenia •

• •

•

Worldwide prevalence estimates range between 0.5% and 1%. Age of first episode is typically younger among men (about 21 years of age) than women (27 years). Of persons with schizophrenia, by age 30, 9 out of 10 men, but only 2 out of 10 women, will manifest the illness (Andreasen & Black, 2006). Persons with schizophrenia pose a high risk for suicide. Approximately one-third will attempt suicide and, eventually, about 1 out of 10 will take their own lives (Andreasen & Black, 2006). A Canadian study found that the direct health care and non-health care costs of schizophrenia were estimated to be 2.02 billion Canadian dollars in 2004. This, combined with a high unemployment rate due to schizophrenia and an added productivity and morbidity and mortality loss of 4.83 billion Canadian dollars, yielded a total cost estimate of 6.85 billion in U.S. and Canadian dollars (Goeree, Farahati, Pyne, & Tarride, 2005). The economic burden of schizophrenia is particularly great during the first year following the index episode, relative to the third year onwards. This finding suggests the need for improved monitoring of persons with schizophrenia upon initial diagnosis (Nicholl, Akhras, Diels, & Schadrack, 2010).

ECONOMIC BURDEN MENTAL ILLNESS The economic burden of mental illness is a world-wide problem. Mental health problems comprise 5 of the 10 leading causes of disability and 10.5% of global burden of disease (Murray, & Lopez, 1996, & 1999). Mental illness imposes a huge burden on individuals, families and society (Centre for Mental Health, 2010). The cost of illness incurred by individuals, employers and governments is enormous and includes: • • • •

Direct healthcare costs (services and materials used in prevention, diagnosis and treatment); Indirect healthcare costs (other resources); Indirect costs (value of the output lost because of inability to work due to illness); Intangible costs (can be valued as quality-adjusted life years; QALY) (Andlin-Sobocki, Jonsson, Wittchen, & Olesen, 2005).

In England alone, mental illness costs over £105.2 billion a year, through the costs of medical or social care, production output losses, and a monetary valuation of the intangible human cost of disability, suffering and distress (Centre for Mental Health, 2010.). In Scotland, the total cost of mental illness is £8.6 billion, which is equivalent to about 9% of its GDP; in Northern Ireland the cost is £2.8 billion, and in Wales £7.2 billion a year. The overall prevalence of mental illness is similar in England and Scotland, but estimates are about 25% higher in Wales and Northern Ireland (Northern Ireland Association for

452

 Global Burden of Mental Disorders

Mental Health & Sainsbury Centre for Mental Health. 2007; Singleton, Bumpstead, O’Brien, Lee, & Meltzer, 2001; Scottish Association for Mental Health & Sainsbury Centre for Mental Health, 2007).

GLOBAL BURDEN ASSESMENT SCALES The GBD uses several metrics to determine health loss: • • •

Years of Life Lost due to premature mortality (YLLs), Years Lived with Disability (YLDs), and Disability-Adjusted Life-Years (DALYs).

Years of life lost (YLL) are calculated by multiplying the number of deaths in each age group by a reference life expectancy at that age – so a disease that kills many young people will generate a greater YLL than a disease that kills older people. Years lived with disability (YLD) are calculated by multiplying the prevalence of a consequence of an illness by its disability weight. Disability weights are based largely on surveys of the general population – to determine how much disability is accounted for by blindness, for example, compared with being unable to walk. Disability adjusted life years (DALY) are the sum of the above two numbers – representing the entire amount of healthy life years lost due to premature death and impaired function caused by an illness (Horowitz, 2013; Christopher & Murray, 2013).

Results of Mental Illnesses Years of Life Lost (YLL): Self-harm, overwhelmingly related to mental health issues, has remained the number 8 cause of years of life lost in the UK from 1990 to 2010 in all age groups, and the number 2 cause in the 20-54-year-old group. The years of life lost due to drug use disorders have increased by 577% for all age groups, and 812% for those 20-54, who have also experienced a 230% increase in alcohol use disorders. •

•

Years lived with disability (YLD): Mental illnesses were the second greatest contributor to years lived with disability in 2010, with six out of the top twenty causes of years lived with disability being mental health disorders – major depression (third largest cause overall), anxiety, drug use, alcohol use, schizophrenia and bipolar disorder. Disability Adjusted Life Years (DALYs): The report showed that almost every mental health disorder increased its burden of disease.Mental and behavioural disorders accounted for 1.65 million disability adjusted life years in 1990, increasing to 1.94 million in 2010 (an increase of 17%). As a point of comparison the number one cause of DALYs is cardiovascular disease which in the same period decreased by 39%. There are few good news stories in the mental health section – almost every mental health disorder increased its burden of disease: ◦◦ Alcohol use disorders increased the number of disability adjusted life years by 56.1%, ◦◦ Unipolar depression increased by 9%, ◦◦ Eating disorders increased by 53.9%, ◦◦ Opioid drug use increased by 56.3% and ◦◦ Schizophrenia increased by 14% (Horowitz, 2013; Christopher & Murray, 2013). 453

 Global Burden of Mental Disorders

DISABILITY ASSESMENT SCALE WHO Composite International Diagnostic Interview [CIDI] (Kessler & Ustun, 2004). The CIDI is a stateof-the-art fully structured research diagnostic interview designed to be used by trained lay interviewers who do not have any clinical experience. CIDI includes a disorder specific measure of role impairment that is administered in exactly the same fashion for each mental disorder assessed in the surveys and for each of the physical disorders assessed for comparison purposes in the surveys. This measure is known as the Sheehan Disability Scales (SDS). The SDS is a widely used self-report measure of condition-specific role impairment that consists of four questions, each asking the respondent to rate on a 0–10 scale the extent to which a particular disorder “interfered with” activities in one of four role domains during the month in the past year when the disorder was most severe. The four domains include: 1. “Your home management, like cleaning, shopping, and taking care of the (house/apartment)” (home); 2. “Your ability to work” (work); 3. “Your social life”, social); and 4. “Your ability to form and maintain close relationships with other people” (close relationships). The 0–10 response options were presented in a visual analogue format with labels for the response options None (0), Mild (1–3), Moderate (4–6), Severe (7–9), and Very Severe (10) (Kessler, AguilarGaxiola, Ustun, & Philip, 2009)

DISABILITY IN INDIA According to Census 2001there are 2.19 crore people with disabilities in India, who constitute 2.13% of the total population. Of these, 9,40,643 are in Karnataka state, with 92,631 being mentally disabled. 75% of all persons with disabilities live in rural areas, 49% are literates and only 34% are employed Chaudhury, Dekaand Chetia (2006) were found more people with schizophrenia in the rural areas and with dementia in the urban areas, with mood and anxiety disorders approximately evenly distributed. They also found that 64% of patients with schizophrenia, around 30% with mood disorders, 16.7% of anxiety disorders, had a disability of more than 40% on the IDEAS scale. Singh and Nizamie (2004) found that only 6% of the guardians of mentally retarded were aware of the persons with disabilities (PWD) Act. They also reported poor awareness and underutilization of disability benefits. Hence, in practice, disability benefits are still elusive for persons with mental disorders.99.4% of the disabled in rural areas had not availed any benefits other than disability pension, which was statistically very highly significant (χ2 =151.73; P 25% of children with ADHD also has an anxiety disorder, and 25% meet the criteria for a mood disorder. In this chapter were covered two important chronic mental illnesses in children- Schizophrenia and Bipolar Mood Disorder. This chapter discusses the clinical features, course, outcome and treatment strategies. Special issues in children are also discussed in terms of diagnosis and treatment.

Early Onset of Schizophrenia Schizophrenia is a chronic, disabling severe mental illness. The incidence of schizophrenia during childhood is rare. The peak age of onset is in early adult life. Most of the cases of childhood schizophrenia diagnosed earlier were actually cases of autism. Currently the same diagnostic criteria are applied for children and adults although as described below there are significant differences between the two.

Classification of Early Onset Schizophrenia In terms of age of onset, • •

Early onset Schizophrenia- onset prior to age 18 years, Very early onset schizophrenia- onset prior to age 13.

557

 Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment

Epidemiology There are very few studies about the population prevalence of childhood schizophrenia. There are numerous reasons for this. The challenges in diagnosis make this a difficult disorder to study. Gillberg, Wahlstrom, Forsman, Hellgren, and Gillberg (1986) found that in the age group of 13-18 years, out of all psychosis 41% had schizophrenia. Prevalence of all psychoses at age 13 years was 0.9 in 10,000. The figure increases during adolescence.

Etiology and Risk Factors Pregnancy and birth complications have been found to be a risk factor for schizophrenia. However it is not clear whether they are a consequence of or cause of abnormal neurodevelopment leading to schizophrenia. Cannabis use has also been proposed to be a risk factor for schizophrenia. However a causal relationship has not been established and a common genetic susceptibility has been proposed. Expressed emotions like critical comments, hostility and over involvement have been found to be associated with relapse of schizophrenia. The role of childhood abuse and neglect in schizophrenia etiology has been found to be inconclusive. Schizophrenia is also heritable many genetic factors have been implicated in the etiology of schizophrenia, however, a direct causal association has not been established.

Diagnostic Criteria and Clinical Features ICD-10 1. Thought echo, thought insertion or withdrawal, and thought broadcasting; 2. Delusions of control, influence, or passivity, clearly referred to body or limb movements or specific thoughts, actions, or sensations; delusional perception; 3. Hallucinatory voices giving a running commentary on the patient’s behaviour, or discussing the patient among themselves, or other types of hallucinatory voices coming from some part of the body; 4. Persistent delusions of other kinds that are culturally inappropriate and completely impossible, such as religious or political identity, or superhuman powers and abilities (e.g. being able to control the weather, or being in communication with aliens from another world); 5. Persistent hallucinations in any modality, when accompanied either by fleeting or half-formed delusions without clear affective content, or by persistent over-valued ideas, or when occurring every day for weeks or months on end; 6. Breaks or interpolations in the train of thought, resulting in incoherence or irrelevant speech, or neologisms; 7. Catatonic behaviour, such as excitement, posturing, or waxy flexibility, negativism, mutism, and stupor; 8. “Negative” symptoms such as marked apathy, paucity of speech, and blunting or incongruity of emotional responses, usually resulting in social withdrawal and lowering of social performance; it must be clear that these are not due to depression or to neuroleptic medication; 9. A significant and consistent change in the overall quality of some aspects of personal behaviour, manifest as loss of interest, aimlessness, idleness, a self-absorbed attitude, and social withdrawal.

558

 Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment

The normal requirement for a diagnosis of schizophrenia is that a minimum of one very clear symptom (and usually two or more if less clear-cut) belonging to any one of the groups listed as (1) to (4) above, or symptoms from at least two of the groups referred to as (5) to (8), should have been clearly present for most of the time during a period of 1 month or more. Schizophrenia is characterized mainly by positive and negative symptoms. Positive symptoms consist of delusions, hallucinations, thought alienation and passivity phenomena. Negative symptoms include poverty of speech, a motivation, anhedonia, restricted affect and attention deficits. Persons may also have cognitive symptoms, symptoms of disorganization and disturbances of affect. In children it may be difficult to elicit and establish the core features of schizophrenia. The onset may be characterized by social withdrawal, decline in school performance, odd behaviours. These symptoms may occur around a year before the onset of clear schizophrenic symptoms. Many children may experience prodromal symptoms which consist of nonspecific symptoms such as bizarre perceptual experiences, odd ideas, eccentric interests and odd behaviours. This may be confused with Schizotypal personality. Though the diagnostic criteria as per ICD-10 and DSM 5 are similar for children and adults, child and adolescent onset schizophrenia is characterized by hallucinations in different modalities, less systematized and fragmented delusions and more negative symptoms as compared to adults.

Rating Scales The Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL) (Kaufman et al., 1997) is a reliable and valid tool to diagnose schizophrenia in children. This tool is used in diagnosis, monitoring of symptoms and also for research purposes. Other than this specific tool in children, other tools like Brief Psychiatric Rating Scale (Overall & Gorham, 1962) and Positive and Negative Symptom Scale (Kay, Flszbein., & Opfer, 1987) are also used.

Course, Outcome, and Prognosis Child and adolescent onset schizophrenia typically runs a chronic course. The short term outcome is worse as compared to first episode psychoses in adults. Only a minority of cases make full recovery after the first episode. The child usually has an unremitting chronic course and there are long term functional impairments in adulthood. The prognostic factors include premorbid cognitive and social functioning. Premorbid cognitive and social impairment predict a poorer prognosis. Extended duration of untreated psychosis, prolonged first episode and presence of negative symptoms also predict a poor outcome.

Treatment The treatment strategies are similar to adult schizophrenia. Antipsychotics are the mainstay of treatment. An important point to consider is that the antipsychotic drugs should be started at lowest possible dose and should be optimized gradually. Treatment should be multimodal including pharmacotherapy, illness education, family intervention and taking care of educational and social needs. There has been ongoing work on early detection and intervention in schizophrenia. Studies have aimed at identifying “ultra-high risk” group for this purpose. Pharmacological intervention in this group has been found to delay the onset of psychosis but not necessarily reduce the incidence of schizophrenia. (McGorry et al., 2002). A meta-analysis done in 2013 (Stafford, 2013) did not find the pharmacological intervention

559

 Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment

using risperidone and olanzapine to be more effective than a psychosocial intervention in preventing the transition to psychosis in the ultra-high risk group. National Institute of Health and Care Excellence [NICE] clinical guideline (NICE, 2013) do not recommend the use of antipsychotics in young people to manage attenuated psychosis symptoms or prevent the transition to psychosis.

Pharmacological Approaches Studies of antipsychotics in children are limited and most of the literature consists of extrapolation of findings from the adult population. Antipsychotic drugs are broadly classified into two groups- Typical and Atypical antipsychotics. The typical antipsychotics include Haloperidol, Trifluoperazine, Chlorpromazine, and the atypical agents include Risperidone, Olanzapine, Clozapine, Quetiapine and Aripiprazole. Aripiprazole, olanzapine, quetiapine, risperidone, and paliperidone have been FDA approved for treatment of pediatric schizophrenia (ages 13-17 yrs). Haloperidol has been found to be effective in children. In head to head trials, atypical antipsychotics have been found to have similar efficacy as typical antipsychotics (Sikich, Hamer, Bashford, Sheitman., & Lieberman, 2004) but better safety profile in terms of extra pyramidal symptoms. However, atypical antipsychotics have some metabolic side effects which requires regular monitoring. The principle is to start with the lowest possible dose of the agent as children are sensitive to the side effects of these medications. Most of the guidelines recommend starting with a low dose of atypical antipsychotic in first episode patients. Children have been found to have more treatment resistance as compared to adults. Clozapine is useful in such cases. However, cloazpine requires regular monitoring of serious adverse effects like neutropenia.

Psychosocial Approaches Psychoeducation and family interventions form an integral part of management of schizophrenia. Explaining about the illness to family, identifying and reducing the burden of family and handling expressed emotions are important components of management. The role of Cognitive- Behaviour Therapy in adults is established for treatment resistant positive symptoms but studies about its efficacy in children are lacking. Cognitive remediation may also be a useful approach in managing cognitive dysfunction.

DIAGNOSIS AND TREATMENT OF SCHIZOPHRENIA The presentation of schizophrenia in children is an atypical presentation with respect to the age of onset. In the beginning, any self-absorbed child would be diagnosed as Schizophrenia. But with progress in the science, newer disorders came to be identified such as Autistic Spectrum Disorder. Many developmental conditions were identified. Many children who were diagnosed with schizophrenia in the 1970s would now be diagnosed with Autism. To diagnose schizophrenia in children, emphasis was put on hallucinations. The criteria given by ICD-10 and DSM-5 are same for children and adults but it is difficult to apply the same criteria directly to diagnose schizophrenia in children. However, the presentation, course and prognosis of Schizophrenia in this age group tend to be different from the adult population. There is a need to follow the course of schizophrenia in children for a longer duration. Intervention strategies and treatment have also borrowed the broader concepts from studies done in adult population. The studies done in the pediatric age group have mainly focused on establishing the

560

 Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment

safety of medications. Recently, efficacy studies have also been done. The psychosocial interventions have not been studied systematically in this age group.

BIPOLAR DISORDER Pediatric bipolar disorder (PBD) has been a diagnostic challenge for the clinicians. The overlap with many disorders, comorbidities and variable course are important aspects of this disorder in this age group. There are two main phenotypes of pediatric bipolar disorder. The “narrow” phenotype is defined by recurrent episodes of major depression and mania, with manic symptoms including elated/expansive mood and grandiosity. The “broad” phenotype of PBD is characterized by chronic, severe mood dysregulation and hyperarousal. Although the mood states in the broad phenotype may evidence episodic variations, they are unlikely to be of the intensity or duration necessary to meet criteria for bipolar disorder (type I or II), and are categorises as Bipolar Disorder Not Otherwise Specified.

Epidemiology In a meta-analysis done by Van Meter, Moreira, and Youngstrom (2011) in participants upto 21 years of age, the overall rate of bipolar disorder was 1.8%. The studies have found marked variations in data because of the methodological differences e.g. whether ICD-10 or DSM criterions are used. The majority of youth with BD experience a depressive episode as the first mood episode, and the mean age of onset of this first episode was 11.75 years (Lewinsohn, Klein., & Seeley, 1995). The prevalence increases nearly twofold from the 13–14-years to the 17–18-years age group (Merikangas, He., & Burstein, 2010).

Comorbidity Comorbidity is high with pediatric BD, particularly with ADHD, anxiety disorders, conduct disorder and ODD, and substance use disorders. It is important to recognize these comorbidities as they influence the course and outcome of pediatric BD. The overlap of the symptoms between pediatric BD and these disorders also needs to be recognized.

Diagnostic Criteria and Clinical Features As per ICD-10, “This disorder is characterized by repeated (i.e. at least two) episodes in which the patient’s mood and activity levels are significantly disturbed, this disturbance consisting on some occasions of an elevation of mood and increased energy and activity (mania or hypomania), and on others of a lowering of mood and decreased energy and activity (depression). Characteristically, recovery is usually complete between episodes, and the incidence in the two sexes is more nearly equal than in other mood disorders. As patients who suffer only from repeated episodes of mania are comparatively rare, and resemble (in their family history, premorbid personality, age of onset, and long-term prognosis) those who also have at least occasional episodes of depression, such patients are classified as bipolar.” As per DSM 5 (American Psychiatric Association, [APA] 2013), for Bipolar Disorder(BD) Type I, person has had at least one manic episode plus any number of hypomanic or depressive episodes. In BD

561

 Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment

Type II, person has had at least one major depressive episode plus any number of hypomanic episodes, but no manic episode. Mania/hypomania is defined as a distinct period of “abnormally and persistently elevated, expansive or irritable mood” and increased energy or activity for 1 week/4 or more days, lasting most of the day and changes in three or more of the following: 1. 2. 3. 4. 5. 6. 7.

Self-esteem/grandiosity, Need for sleep (decreased), Talkativeness, Racing thoughts, Distractibility, Goal-directedness, Involvement in risky activities.

In a manic episode, individual is noted to have marked impairment in functioning, psychotic features, or the need to be hospitalized to ensure safety. For a hypomanic episode, the disturbance in mood and change in functioning is uncharacteristic and observable by others, but the episode is not severe enough to case marked impairment in functioning or to necessitate hospitalization. An episode of mania or hypomania must not be attributable to the physiological effects of a substance or to a medical condition.

Major Depressive Episode Five (or more) of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at least one of the symptoms 1. Depressed mood most of the day, nearly every day. In children and adolescents, can be irritable mood. 2. Markedly diminished interest or pleasure in all, or almost all, activities most of the day, nearly every day. 3. Significant weight loss when not dieting or weight gain (e.g., a change of more than 5% of body weight in a month), or decrease or increase in appetite nearly every day. In children, consider failure to make expected weight gain. 4. Insomnia or hypersomnia nearly every day. 5. Psychomotor agitation or retardation nearly every day. 6. Fatigue or loss of energy nearly every day. 7. Feelings of worthlessness or excessive or inappropriate guilt nearly every day. 8. Diminished ability to think or concentrate, or indecisiveness, nearly every day. 9. Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideation without a specific plan, or a suicide attempt or a specific plan for committing suicide. The symptoms cause clinically significant distress or impairment in social, occupational, or other important areas of functioning and the episode is not attributable to the physiological effects of a substance or another medical condition.

562

 Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment

Diagnostic Challenges Pediatric bipolar disorder is a difficult condition to diagnose. Children do not present with the typical manic symptoms as seen in adults during a manic episode. Children present with irritability. It is difficult for a child to express euphoria. In children rapid shifts of mood are common further causing difficulty in diagnosing. There is also significant overlap in symptom profile with some major childhood disorders. Attention Deficit Hyperactivity Disorder is difficult to distinguish from a manic episode. Episodic nature and elation may help in diagnosing as Bipolar disorder. Conduct disorder and Oppositional defiant disorder may also resemble manic presentation. Substance use in adolescents also poses challenge towards diagnosis of Bipolar disorder. Chronic irritability needs to be differentiated from Bipolar disorder. The debate about whether chronic irritability is a developmental form of BD has given rise to the introduction of Disruptive Mood Dysregulation Disorder (DMDD) in DSM-5, intended in part to decrease inaccurate diagnoses of BD. •

Rating Scales: K-SADS-PL can be used for affective disorders in children. In addition, for manic episode, Child Mania Rating Scale (Pavuluri, Henry, Devineni, Carbray., & Birmaher, 2006), and the parent version of Young Mania Rating Scale (P-YMRS) (Gracious, Youngstorm., & Findling, 2002) can be used. These scales have items specific to this age group.

Course and Outcome The COBY study (Birmaher et al., 2009) is a landmark study that has provided great insights into the course of bipolar disorder in youth. Early onset of bipolar disorder predicts a more chronic and fluctuating course. There are more chances of mixed and cycling episodes. Early onset bipolar disorder is also associated with higher comorbidity and suicidality. The episodes tend to be longer. Rapid mood changes and subsyndromal episodes are common in this population.

Treatment The treatment of bipolar disorder is divided into three phases- Acute, Continuation and Maintenance. The acute phase is concerned with the control of the acute symptoms that the child presents with. Continuation phase consists of continuing the medicines with which the child responded in the acute phase with monitoring of side effects. Maintenance phase aims at long term prophylaxis to prevent relapse.

Pharmacological Treatment Pharmacological treatment studies in pediatric bipolar disorder have mainly focused on the manic episode and minimally on the depressive episode. There are no FDA-approved medications for the treatment of bipolar depression in children and adolescents. Atypical antipsychotics (risperidone, quetiapine, ziprasidone, and olanzapine) and lithium (ages 12–17years) have been approved for mania or mixed episodes in youth (DeFilippis & Wagner, 2013). Recently Asenapine has also obtained approval for use in Pediatric Bipolar disorder. No agent is approved for children less than 10 years’ age. It has been seen that children are often prescribed a combination of many drugs by clinicians in a bid to get response.

563

 Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment

However, combination treatment does not offer any additional benefit and only adds to the side effects. For a manic episode, starting an atypical antipsychotic is a good option (Hauser & Correll, 2013). Lithium and Valproate are also useful options. Some evidence exists for Carbamazepine. The metabolic side effects of atypical antipsychotics are an important source of concern and need to be monitored regularly. For a bipolar depressive episode, not many trials are available. Studies support use of Lithium, Aripoprazole (Findling, Nyilas., & Forbes, 2009; Correll, & Nyilas, 2013) and Quetiapine (Delbello, Schwiers., & Rosenberg, 2002). An important aspect of management is use of Selective Serotonin Reuptake Inhibitors (SSRIs). SSRIs are frequently prescribed in depressive episodes, but their efficacy in bipolar depression in this age group has not been established. In fact, they may lead to treatment emergent affective switch to a hypomanic/manic episode.

Psychosocial Intervention Psychosocial treatments are useful adjunct to pharmacological treatment in pediatric bipolar disorder. According to American Academy of Child and Adolescent Psychiatry Practice Parameter for the treatment of PBD (McClellan, Kowatch., & Findling, 2007), “a comprehensive multimodal treatment approach combining psychopharmacology with adjunctive psychosocial therapies is almost always indicated for early-onset BD”. Psychoeducational approaches, Family Focused Therapy (FFT), Inter personal and Social Rhythm Therapy (IPSRT) and Cognitive Behavior Therapy (CBT) are useful approaches in Pediatric Bipolar Disorder. These therapies were mainly developed for adult bipolar disorder but modules have been developed for Pediatric Bipolar Disorder as well and have been subjected to randomized controlled trials.

DIAGNOSIS AND TREATMENT OF PEDIATRIC BIPOLAR DISORDER The diagnosis and intervention strategies in Pediatric Bipolar disorder have been borrowed heavily from the adult counterparts. Over the years, important differences in the presentation, course and outcome of pediatric bipolar disorders have been identified. The nature of presentation, comorbidities and the chronic course make this a difficult disorder to manage. Studies are focusing on evaluating the long term course of this disorder. More and more studies are also focussing on the management strategies of this disorder. The pharmacological and non-pharmacological intervention strategies need more systematic evaluation in this group especially less than 10 years’ age.

CONCLUSION As researchers support the early intervention affirm, the at risk mental state represents an intermediate state, which begins to be followed up by specialists, and, therefore, no longer summarizes the health state, but does not necessarily implies the development of the disorder, and it is not equivalent to the diagnosis of the disease. If the interventions constructed in the context of the services of early detection, in a first moment, represented the refinement of clinical instruments, especially for patients living the first episode, for risk cases, it is not known what to offer exactly; thus, an intervention that can change

564

 Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment

the alleged vulnerability of child adolescents remains undefined. In the clinical dimension, the discussion on the early intervention directed to the first break, with special attention to the period of untreated psychosis, may represent the construction of care instruments and strategies useful in the assistance to the psychopathology of child and adolescent population. At the same time, the formalization of the diagnostic category of bipolar disorder and psychosis points more to an intention of applying the risk thinking to the psychiatric field, and of carrying out preventive actions whose efficacy and safety are not known. The questioning about the boundaries between normality and pathology is not only beneficial, but also essential to the construction of care practices that are more sensitive to psychic suffering.

REFERENCES American Psychiatric Association. (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Washington, DC: Author. Birmaher, B., Axelson, D., Goldstein, B., Strober, M., Gill, M. K., Hunt, J., ... Keller, M. (2009). FourYear Longitudinal Course of Children and Adolescents with Bipolar Spectrum Disorder: The Course and Outcome of Bipolar Youth (COBY) Study. The American Journal of Psychiatry, 166(7), 795–804. doi:10.1176/appi.ajp.2009.08101569 PMID:19448190 DeFilippis, M. S., & Wagner, K. D. (2013). Bipolar depression in children and adolescents. CNS Spectrums, 18(04), 209–213. doi:10.1017/S1092852913000217 PMID:23570693 DelBello, M. P., Schwiers, M. L., Rosenberg, H. L., & Strakowski, S. M. (2002). A double-blind, randomized, placebo-controlled study of quetiapine as adjunctive treatment for adolescent mania. Journal of the American Academy of Child and Adolescent Psychiatry, 41(10), 1216–1223. doi:10.1097/00004583200210000-00011 PMID:12364843 Findling, R. L., Correll, C. U., Nyilas, M., Forbes, R. A., McQuade, R. D., Jin, N., ... Carlson, G. A. (2013). Aripiprazole for the treatment of pediatric bipolar I disorder: A 30-week, randomized, placebo controlled study. Bipolar Disorders, 15(2), 138–149. doi:10.1111/bdi.12042 PMID:23437959 Findling, R. L., Nyilas, M., Forbes, R. A., McQuade, R. D., Jin, N., Iwamoto, T., ... Chang, K. (2009). Acute treatment of pediatric bipolar I disorder, manic or mixed episode, with aripiprazole: A randomized, double-blind, placebo-controlled study. The Journal of Clinical Psychiatry, 70(10), 1441–1451. doi:10.4088/JCP.09m05164yel PMID:19906348 Gillberg, C., Wahlstrom, J., Forsman, A., Hellgren, L., & Gillberg, J. C. (1986). Teenage psychoses: Epidemiology, classification and reduced optimality in the pre-, peri- and neonatal periods. Journal of Child Psychology and Psychiatry, and Allied Disciplines, 27(1), 87–98. doi:10.1111/j.1469-7610.1986. tb00624.x PMID:3949910 Gracious, B. L., Youngstorm, E. A., & Findling, R. L. (2002). Discriminative validity of a parent version of the Young Mania rating Scale. Journal of the American Academy of Child and Adolescent Psychiatry, 41(11), 1350–1359. doi:10.1097/00004583-200211000-00017 PMID:12410078

565

 Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment

Hauser, M., & Correll, C. U. (2013). The significance of at-risk or prodromal symptoms for bipolar I disorder in children and adolescents. Canadian Journal of Psychiatry, 58, 22–31. PMID:23327753 Kaufman, J., Birmaher, B., Brent, D., Rao, U. M. A., Flynn, C., Moreci, P., & Ryan, N. (1997). Schedule for affective disorders and schizophrenia for school-age children-present and lifetime version (K-SADSPL): Initial reliability and validity data. Journal of the American Academy of Child and Adolescent Psychiatry, 36(7), 980–988. doi:10.1097/00004583-199707000-00021 PMID:9204677 Kay, S. R., Flszbein, A., & Opfer, L. A. (1987). The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophrenia Bulletin, 13(2), 261–276. doi:10.1093chbul/13.2.261 PMID:3616518 Lewinsohn, P. M., Klein, D. N., & Seeley, J. R. (1995). Bipolar disorders in a community sample of older adolescents: Prevalence, phenomenology, comorbidity, and course. Journal of the American Academy of Child and Adolescent Psychiatry, 34(4), 454–463. doi:10.1097/00004583-199504000-00012 PMID:7751259 McClellan, J., Kowatch, R., & Findling, R. L. (2007). Practice parameter for the assessment and treatment of children and adolescents with bipolar disorder. Journal of the American Academy of Child and Adolescent Psychiatry, 46(1), 107–125. doi:10.1097/01.chi.0000242240.69678.c4 PMID:17195735 McGorry, P. D., Yung, A. R., Phillips, L. J., Yuen, H. P., Francey, S., Cosgrave, E. M., ... Jackson, H. (2002). Randomized controlled trial of interventions designed to reduce the risk of progression to firstepisode psychosis in a clinical sample with subthreshold symptoms. Archives of General Psychiatry, 59(10), 921–928. doi:10.1001/archpsyc.59.10.921 PMID:12365879 Merikangas, K. R., He, J. P., Burstein, M., Swanson, S. A., Avenevoli, S., Cui, L., ... Swendsen, J. (2010). Lifetime prevalence of mental disorders in U.S. adolescents: Results from the National Comorbidity Survey Replication – Adolescent Supplement (NCS-A). Journal of the American Academy of Child and Adolescent Psychiatry, 49(10), 980–989. doi:10.1016/j.jaac.2010.05.017 PMID:20855043 National Institute of Health and Care Excellence. (2013). Psychosis and schizophrenia in children and young people. Retrieved 09 January, 2106, from https://www.nice.org.uk/guidance/indevelopment/gidcgwave0797 Overall, J. E., & Gorham, D. R. (1962). The brief psychiatric rating scale. Psychological Reports, 10(3), 799–812. doi:10.2466/pr0.1962.10.3.799 Pavuluri, M. N., Henry, D. B., Devineni, B., Carbray, J. A., & Birmaher, B. (2006). Child mania rating scale: Development, reliability, and validity. Journal of the American Academy of Child and Adolescent Psychiatry, 45(5), 550–560. doi:10.1097/01.chi.0000205700.40700.50 PMID:16601399 Sikich, L., Hamer, R. M., Bashford, R. A., Sheitman, B. B., & Lieberman, J. A. (2004). A pilot study of risperidone, olanzapine, and haloperidol in psychotic youth: A double-blind, randomized, 8-week trial. Neuropsychopharmacology, 29(1), 133–145. doi:10.1038j.npp.1300327 PMID:14583740 Stafford, M. R., Jackson, H., Mayo-Wilson, E., Morrison, A. P., & Kendall, T. (2013). Early interventions to prevent psychosis: Systematicreviewandmeta-analysis. British Medical Journal, 346(jan18 1), f185. doi:10.1136/bmj.f185 PMID:23335473

566

 Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment

Van Meter, A. R., Moreira, A. L., & Youngstrom, E. A. (2011). Meta-analysis of epidemiologic studies of pediatric bipolar disorder. The Journal of Clinical Psychiatry, 72(9), 1250–1256. doi:10.4088/ JCP.10m06290 PMID:21672501 World Health Organization. (1992). The ICD-10 classification of mental and behavioural disorders: clinical descriptions and diagnostic guidelines. Geneva: World Health Organization.

KEY TERMS AND DEFINITIONS Childhood Schizophrenia: A type of schizophrenia, present in children. Children’s symptoms start before the age of 13 and characterized by hallucinations, delusions, disordered thoughts and negative symptoms. The onset is often insidious with cognitive deterioration. Depression: A state of low mood and aversion to activity that can affect a person’s thoughts, behavior, feelings and sense of well-being. People with depressed mood can feel sad, anxious, empty, hopeless, helpless, worthless, guilty, irritable, ashamed or restless. They may lose interest in activities that were once pleasurable, experience loss of appetite or overeating, have problems concentrating, remembering details or making decisions, and may contemplate, attempt or commit suicide. Insomnia, excessive sleeping, fatigue, aches, pains, digestive problems or reduced energy may also be present. Early Onset Schizophrenia: A type of schizophrenia, present in children. Children’s symptoms start before the age of 13 and characterized by hallucinations, delusions, disordered thoughts and negative symptoms. The onset is often insidious with cognitive deterioration. Mania: The mood of an abnormally elevated arousal energy level, or “a state of heightened overall activation with enhanced affective expression together with lability of affect. Although mania is often conceived as a “mirror image” to depression, the heightened mood can be either euphoric or irritable; indeed, as the mania worsens, irritability often becomes more pronounced and may eventuate in violence. Pediatric Bipolar Disorder: Bipolar disorder starts during childhood or the early teen years is called pediatric bipolar disorder. The onset in characterized with mixed-dysphoric, labile and rapid changing presentation; the symptoms are more or less commons.

This research was previously published in Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment edited by Barre Vijaya Prasad, pages 258-269, copyright year 2017 by Medical Information Science Reference (an imprint of IGI Global).

567

568

Chapter 28

Chronic Mental Illness in Prisons: Global Scenario

Meghamala S. Tavaragi Dharwad Institute of Mental Health and Neurosciences, India

ABSTRACT It has been known that psychiatric disorders are highly prevalent among prisoners. Many people with identifiable psychiatric illness do conflict with the law, often by no fault of their own but because of symptoms of their psychiatric illness and end up in jails. Poor communication between the prison, court, and hospital systems hinders the assessment and management of the mentally disordered offender, and medical intervention can actually delay release from custody. In conclusion Prisons are detrimental to mental-health, and the standards of psychiatric care are significantly lower than those for the general public. Certain remedial measures are to be implemented for a better future of prison and community because ultimately these prisoners will be released from prison and become a part of community. Beginning of reforms is the immediate need as a long journey ahead.

INTRODUCTION Mental Health and Prison Mental disorders occur at high rates in all countries of the world. An estimated 450 million people worldwide suffer from mental or behavioural disorders (World Health Report, 2001). These disorders are especially prevalent in prison populations (Brinded, 2001; Brugha, 2005; Holley, Arboleda, & Love, 1995).The disproportionately high rate of mental disorders in prisons is related to several factors: the widespread misconception that all people with mental disorders are a danger to the public; the general intolerance of many societies to difficult or disturbing behavior, the failure to promote treatment, care and rehabilitation, and above all, the lack of, or poor access to, mental health services in many countries. Many of these disorders may be present before admission to prison, and may be further exacerbated by DOI: 10.4018/978-1-5225-7122-3.ch028

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Chronic Mental Illness in Prisons

the stress of imprisonment. However, mental disorders may also develop during imprisonment itself as a consequence of prevailing conditions and also possibly due to torture or other human rights violations. Prisons are bad for mental health. There are factors in many prisons that have negative effects on mental health, including: overcrowding, various forms of violence, enforced solitude or conversely, lack of privacy, lack of meaningful activity, isolation from social networks, insecurity about future prospects (work, relationships etc), and inadequate health services, especially mental health services, in prisons. The increased risk of suicide in prisons (often related to depression) is, unfortunately, one common manifestation of the cumulative effects of these factors. Prisons are sometimes used as dumping grounds for people with mental disorders. In some countries, people with severe mental disorders are inappropriately locked up in prisons simply because of the lack of mental health services. People with substance abuse disorders or people who, at least in part due to a mental disorder, have committed minor offences are often sent to prison rather than treated for their disorder. These disorders therefore continue to go unnoticed, undiagnosed and untreated. It has been known that psychiatric disorders are highly prevalent among prisoners (Coid, 1984). Many people with identifiable psychiatric illness do conflict with the law, often by no fault of their own but because of symptoms of their psychiatric illness and end up in jails. Such symptoms include impaired judgment, lack of impulse control, suspiciousness, disinhibition, paranoia, inability to trust others, delusions and hallucinations. It is quite likely that act of incarceration may well exacerbate underlying psychiatric conditions. The effect of such incarceration may well be so severe as to precipitate mental abnormality in vulnerable individuals (Coid, 1984). Different levels of stress during incarceration give rise to different incidence of psychiatric morbidity among remand prisoners (Anderson et al., 2000).

PRISONS AND PRISONER STATISTICS IN WORLD More than 10.1 million people are held in penal institutions throughout the world, mostly as pre-trial detainees/remand prisoners or as sentenced prisoners. Almost half of these are in the United States (2.29m), Russia (0.81m) or China (1.65m sentenced prisoners). In addition, more than 650,000 are in ‘detention centres’ in China; if these are included the overall Chinese total is over 2.3 million and the world total more than 10.75 million. The United States has the highest prison population rate in the world, 743 per 100,000 of the national population, followed by Rwanda (c. 595), Russia (568), Georgia (547), U.S. Virgin Is. (539), Seychelles (507), St Kitts & Nevis (495), British Virgin Is. (468), Belize (439), Dominica (431), Bermuda (428), Grenada (423) and Curacao (422). However, more than half the countries and territories (54%) have rates below 150 per 100,000. The world population at mid-2010 was estimated at 6.9 billion (United Nations); if set against the world prison population of 10.1 million this would produce a world prison population rate of 146 per 100,000 (156 per 100,000 if set against a world prison population of 10.75 million). Prison population rates vary considerably between different regions of the world, and between different parts of the same continent, for example: 1. In Africa the median rate for western African countries is 47.5 whereas for southern African countries it is 219.

569

 Chronic Mental Illness in Prisons

2. In the Americas the median rate for South American countries is 175 whereas for Caribbean countries it is 357.5. 3. In Asia the median rate for south central Asian countries (mainly the Indian sub-continent) is 42 whereas for eastern Asian countries it is 155.5. 4. In Europe the median rate for western European countries is 96 whereas for the countries spanning Europe and Asia (e.g. Russia & Turkey) it is 228. 5. In Oceania (including Australia and New Zealand) the median rate is 135. Prison populations are growing in all five continents. Updated information on countries included in previous editions of the World Prison Population List shows that prison populations have risen in 78% of countries (in 71% of countries in Africa, 82% in the Americas, 80% in Asia, 74% in Europe and 80% in Oceania (Walmsley, 2005). There are over 10 million prisoners worldwide (Fazel & Seewald, 2012), a population that has been growing by about 1 million per decade. In 2008, the USA had the largest number of people imprisoned at 2.3 million and the highest rate per head of population (at 756 per 100 000 people compared with a median of 145 per 100 000 worldwide), and China, Russia, Brazil and India had more than a quarter of a million prisoners each ((Fazel & Seewald, 2012), It has been widely reported that prisoners have elevated rates of psychiatric disorders compared with the general population, including for psychosis, depression, personality disorder and substance misuse, which are risk factors for elevated suicide rates (Baillargeon, Penn, Thomas, Temple, & Murray, 2009; Fazel, Cartwright, Norman-Nott, & Hawton, 2008) premature mortality on release from prison (Kariminia et al., 2007) and increased reoffending rates (Fazel, & Yu, 2011; Baillargeon, Binswanger., & Murray, 2009).

PRISONS AND PRISONER STATISTICS IN INDIA During the ancient times, ‘Prisons’ were considered as a ‘House of Captives’ where the prisoners were held for deterrent and retributory punishment. Determined and sustained efforts of the thinkers and human right activists in this field led to progressive transformation of the concept of ‘deterrence and retribution’ into ‘reformation and rehabilitation’. Therefore, under the modern correctional philosophy prisons are now considered as correctional institutions where the prisoners are sent after punishment for their reformation and rehabilitation. Prisons have now been considered as a ‘community’, reflecting the multifaceted socio-cultural, socio-economic and socio-political scenario of the society as a whole. Prisoners of all sections of society are confined in prisons and conscious efforts are being made to provide such conditions to the prisoners in prisons as are conducive to their physical as well as mental treatment and care, and to maintain their human dignity, as also visualized by Indian father of the Nation, Mahatma Gandhi. Mahatma Gandhi had visualized crime and prisons in therapeutic context and observed that ‘Crime is the outcome of a disease mind and jail must have an environment of hospital for their treatment and care’. This principle has become a State Policy in India and efforts have all along been made to protect all basic rights of prisoners to maintain their human dignity during the period of their incarceration. In India, prison is State subject. Thus, States have the primary role, responsibility and authority w. r. t. prison laws, rules and regulations.

570

 Chronic Mental Illness in Prisons

Prison Statistics of India: 2012 Total number of jails in the country are 1,394, Central jails-127, District jails-340, Sub jails-806, Women jails-20, Open jails-46, Borstal schools-21, Special jails-31 and Other jails-3. Total capacity of jails in the country is 3,43,169. Central jails-1,46,648 (42.7%), District jails-1,26,110 (36.7%), Sub jails-48,474 (14.1%). Women jails-4,817 (1.4%), Open jails-4,028 (1.2%), Borstal schools-2,438 (0.7%), Special jails-10,331 (3.0%) and other jails-323 (0.1%). Total number of jail inmates as on 31.12.2013 is 3,85,135; Male-3,68,184 (95.6%), Female-16,951 (4.4%). Occupancy rate in 2010-115.1%, 2011112.1%, 2012-112.2%. 1. Convicts are 1,27,789 (33.2% of total inmates), Male-1,22,776 (96.1% of total convicts), Female-5,013 (3.9% of total convicts). 2. Under trials are 2,54,857 (66.2% of total inmates), Male-2,43,055 (95.4% of total under trials), Female-11,802 (4.6% of total under trials). 3. Detenues are 1,922 (0.5% of total inmates), Male-1,832 (95.3% of total detenues), Female-90 (4.7% of total detenues) others-567 (0.1% of total inmates). The highest number of 80,311 inmates (77,148 male and 3,163 female) were reported from Uttarϖ Pradesh (20.9%) followed by Madhya Pradesh 33,959 (32,778 male and 1,181 female), Bihar 28,550 (27,622 male and 928 female), Maharashtra 24,509 (23,171 male and 1,338 female) and Punjab 23,219 (21,944 male and 1,275 female) at the end of the year 2012. Chhattisgarh reported the highest overcrowding in prisons (252.6%) followed by Delhi (193.8%). A total of 344 women convicts with their 382 children and 1,226 women under trials with their 1,397 children were lodged in various prisons in the country at the end of 2012. A total of 4,470 inmates having mental illness out of 3,38,135 inmates, accounting for 1.2% of total inmates, were lodged in various jails during 2012. Prison population is number of prisoners kept in prison at any given point of time. The prison population keeps changing because of addition of new prisoners and release of the old ones (Prison Statistics India, 2012).

STATISTICS OF INCIDENCE AND PREVALENCE OF MENTAL ILLNESS IN PRISONS ACROSS THE WORLD Country Wise 1. According to a new report from the Treatment Advocacy Center (TAC), a nonprofit advocacy organization, the United States has fully returned to the 18th-century model of incarcerating the mentally ill in correctional institutions rather than treating them in health care facilities like any other sick people. In 2012, there were roughly 356,268 inmates with severe mental illnesses in prisons and jails, while only 35,000 people with the same diseases were in state psychiatric hospitals (Mencimer, 2014). 2. The failure to treat the mentally ill properly in hospitals is directly related to recent violent crimes. In case of Virginia, where the largest mental institution is the largest state prison and the state’s jails hold three times more people with serious mental illnesses than the state hospitals do. The

571

 Chronic Mental Illness in Prisons

3.

4.

5.

6.

problem is so bad that in 2011, a Virginia Beach sheriff offered to transfer part of his jail budget to the mental-health system to try to get some of the sick people out of his institution and into proper care (Brownell, 2014). The United States has the highest rate of adult incarceration among the developed countries, with 2.2 million currently in jails and prisons. Those with mental disorders have been increasingly incarcerated during the past three decades, probably as a result of the deinstitutionalization of the state mental health system. Correctional institutions have become the de facto state hospitals, and there are more seriously and persistently mentally ill in prisons than in all state hospitals in the United States. A study by Doris and Lauren (2006) the U.S. Department of Justice found that more than half of all prison and jail inmates have a mental health problem compared with 11 percent of the general population, yet only one in three prison inmates and one in six jail inmates receive any form of mental health treatment (Tanay, 2007). According to the Bureau of Justice Statistics, 56 percent of state prisoners and 45 percent of federal prisoners have symptoms or a recent history of mental health problems (Doris & Lauren, 2006). Prisoners have high rates of mental illness-including such serious disorders as schizophrenia, bipolar disorder, and major depression-that are two to four times higher than members of the general public. The numbers are staggering: over the past 15 years, the number of mentally ill people in prison in California has almost doubled (California Department of Corrections and Rehabilitation report [CDCRR], 2014). Today, 45 percent of state prison inmates have been treated for severe mental illness within the past year. The Los Angeles County Jail is “the largest mental health provider in the county,” according to the former official in charge of the facility (Los Angeles Times, 2010). As usual, what started in California spread throughout the country.In 1971 there were 20,000 people in California prisons; by 2010 the population had increased to 162,000 people, of which 45 percent are estimated to be mentally ill (CDCRR, 2014). South Africa has a rapidly growing prison population and has the most prisoners amongst all African countries. It also has the world’s seventh highest number of prisoners, outranking countries with up to nearly five times its population. In the continent of Africa, South Africa has the highest ratio of prisoners to total population; 348 prisoners for every 100, 000 people. International studies have consistently shown a high prevalence of mental disorders among prisoners.

Butler et al. (1997) in New South Wales, Australia screened both sentenced and reception prisoners and found that 43% of those prisoners screened had at least one of the following mental diagnoses: psychosis, anxiety or affective disorders in the past 12 months. Study in Canada comparing the prevalence of mental disorders in prisoners and the community found a very high rate of Axis 1 disorders among prisoners. Prisoners had a 91.7% lifetime prevalence of psychiatric disorders while 76.7% showed symptoms in the past six months. This study also found a high rate of comorbidity with substance use disorders (Naidoo & Mkize, 2012). Prison population in Durban, South Africa, one of the largest prisons in the Southern hemisphere.193 prisoners were interviewed using the Mini Neuro-psychiatric Interview, a screening questionnaire and a demographic questionnaire. The study demonstrated that 55.4% of prisoners had an Axis 1 disorder. The commonest disorder being substance and alcohol use disorders (42.0%). 23.3% of prisoners were diagnosed with current psychotic, bipolar, depressive and anxiety disorders. 46.1% were diagnosed with antisocial personality disorder (Naidoo & Mkize, 2012). 572

 Chronic Mental Illness in Prisons

PERCENTAGE PREVALENCE OF VARIOUS PSYCHIATRIC ILLNESSES IN PRISONS: INTERNATIONAL PERSEPECTIVE Indian Scenario Somsundram (1997) studied 53 criminal patients admitted to the Government Mental Hospital. It was found that 40 of them suffered from schizophrenia, 10 from affective disorders (3 mania and 7 depression), 1 epilepsy and 2 temporary insanity. The criminal patients who were inpatients in the Government Mental Hospital Madras during 1972 were taken into consideration by Somsundram (1974). Only guilty but insane (19) out of total 79 inpatients were studied and he found that 18 were schizophrenic. Jha (1968) studied case records of criminal patients admitted in Ranchi Mansik Arogyashala and found 338 schizophrenic patients out of 1011 criminal patients admitted there during the years 1925 to 1963 giving an incidence of 33%. Singh and Verma (1976) in an Indian Prison study, studied 50 consecutive subjects convicted of murder or attempt to murder and imprisoned at Central Jail Amritsar from January 1970 onwards. Fifteen (30%) of the subjects were found to have no evidence of psychiatric illness. The most common diagnosis was anxiety neurosis in 4 (8%) and depressive reaction in 8 (16%) cases. Psychopathic personality disorder was found in 8 (16%) cases, schizophrenia in 2 (4%), sexual deviation in 2 (4%), alcohol addiction in 6 (12%) and opium dependence in 5 (10%). Mohan and Dhar (2001) assessed 120 under trials as per ICD-10 and 9% were diagnosed having different psychiatric disorder. Twenty-eight percent suffered from schizophrenic psychosis, 13% from MDP, 14% from anxiety state and depression, 9% from malingering and 7% from seizure disorder in the assessed number of under trials. Pre-existing psychiatric illness before committing major crime was detected in 35% of under trials referred. Distribution of total sample according to total period of stay among prisoners with and without psychiatric illness (N=500). Among prisoners without psychiatric illness, 39.90% stayed for 3–6 years, 22.83% stayed for 1–3 years, 16.54% stayed for 6–9 years, 12.86% stayed for less than 1 year, 4.72% stayed for 9–12 years and 3.15% stayed for >12 years see the Table 1, (Sandeep, Paramjit, & Aseem, 2011). A study commissioned by the National Commission for Women in the Central Prison, Bangalore (Murthy et al., 1998), found higher rates of symptoms of common mental disorder among under trials compared

Table 1. Distribution of total sample according to total period of stay among prisoners with and without psychiatric illness (N=500) age Duration of Stay (in Years)

Prisoners with Psychiatric Illness

Prisoners without Psychiatric Illness

No

%

No

%

12

4

3.36

12

3.15

119

100.0

381

100.0

573

 Chronic Mental Illness in Prisons

to convict prisoners. Common symptoms were unhappiness (73% versus 43%), worrying (65% versus 29%), poor sleep and appetite (65% of under trials). In the recent Prison Mental Health Study (Math et al., 2011), of 197 women who were interviewed for psychiatric morbidity, 2.5% had dysthymia (minor depression), 4.6% had specific phobia, 1.5% social phobia and one person had a panic disorder. Among the entire prison population evaluated for this study (5024), lifetime and current rates of dysthymia were 2.9% and 2.5% respectively. Prevalence of major depressive disorders was relatively higher. Similarly in another study done by Suresh, Pratima, Rajani, Naveen, and Madhusudhan (2011) Prevalence of common mental disorders among prisoners in Central Prison, Bangalore, was shown in Table 2.

World Scenario 1. Steadman, Fabisiak, Dvoskin, and Holohean (1987) studied a random sample of 3332 inmates representing 9.4% of New York’s general prison population as well as 352 of the 360 inmates in the prison’s mental health units. They found that 8% of the sample had severe psychiatric functional disabilities that clearly warranted some type of mental health intervention, and another 16% had significant mental disabilities that required periodic services (specific diagnoses were not given). Agbahowe, Fabisiak, Dvoskin and Holohean (1998) conducted a study to find prevalence of psychiatric morbidity among convicted inmates at a medium security prison in Nigeria. They assessed 100 inmates and found schizophrenia in 2, major depression in 2, recurrent mild depression in 21, generalized anxiety disorder in 8 and somatization disorder in 1. Maden, Swinton and Gunn (1992) did retrospective, self-report survey of pre-arrest drug use in a representative sample of 1751 men serving a prison sentence. Reported drugs used were cannabis (34%), opiates (9%), amphetamines (9%) and cocaine (5%), including 1% ‘Crack’ users. Pre-arrest injecting was reported by 11% of inmates. Drug dependence was reported by 11%, including 7% dependent on opiates, 2% on amphetamines and 1% on cocaine. Mason, Birmingham and Grubin (1997) concluded that of 548 newly remanded prisoners studied, 57% men were using illicit drugs and 33% met DSM-IV drug misuse or dependence criteria. Thirty two percent met misuse or dependence criteria for alcohol. Table 2. Prevalence of common mental disorders among prisoners in Central Prison, Bangalore Disorder

Lifetime Diagnosis %

Current Diagnosis %

Panid disorder

1.0

0.9

Agoraphobia

0.3

0.2

Social Phobia

1.8

0.6

Obsessive compulsive disorder

-

0.1

Post traumatic stress disorder

-

0.3

Generalised anxiety disorder

-

0.3

Hypochondriasis

-

0.1

Body dysmorphic disorder

-

0.8

Somatisation

2.1

1.7

Pain disorder

-

5.4

(Suresh, Pratima, Rajani, Naveen & Madhusudhan, 2011)

574

 Chronic Mental Illness in Prisons

2. Prisoners have a higher incidence of mental health problems, in particular, neurotic disorders, compared to the general population (Marshall & Orr, 1999). In male prisoners, the prevalence of any neurotic disorder in the week before the study was, 59% in remand and 40% in sentenced prisoners. In female prisoners, 76% and 63% of remanded and sentenced prisoners respectively had a neurotic disorder. Estimates of mental health morbidity in UK local prisons, HMP Littlehey and HMP Whitemoor, show a high prevalence of personality and neurotic disorders of 64% and 40% respectively. This translates to a heavy burden of illness, with about 723 inmates with personality disorders and 452 with neurotic disorders in the two prisons. The prevalence rates for self-harm and suicide (7%) were also high (Joint Strategic Needs Assessment, 2008). The Office of National Statistics survey was carried out in 131 of the 133 English and Welsh prisons. Of 51,834 remanded and sentenced males, 5% were interviewed as the initial sample. 6,500 of that sample group had personality disorders, 55% had neurotic disorders, 60% showed hazardous drinking in the year prior to incarceration and 10% had psychiatric disorders. 62% of sentenced women and up to 81% of those on remand reported sleep problems. 54% of women prisoners reported symptoms of depression. Women prisoners were about twice as likely as men to suffer from post-traumatic stress than male prisoners (Singleton et al, 1998). Eating disorders presented in over 6% of women in the sample who were diagnosed with anorexia. Rates for bulimia were higher, at 14% for the whole sample (15% for remand and 14% for sentenced prisoners). 59% of remand and 40% of sentenced male prisoners in England and Wales had a neurotic disorder, the corresponding figures for women were 76% and 63%. Sixty percent of the women who took part in the study had mental disorders; 35% had diagnoses of personality disorder; none had psychotic disorders (such as schizophrenia for example); 35% had current neurotic disorders (such as depression, anxiety disorders and phobias), nearly all of whom were depressed; 13% had been drinking alcohol at hazardous levels in the year prior to imprisonment, and 36% had been abusing or were dependent on drugs in the year prior to imprisonment. None of the participants reported using alcohol or drugs in prison (Suresh, Pratima, Rajani, Naveen & Madhusudhan, 2011). 3. The overall prevalence of 3.7% of male and female prisoners with a psychotic illness, and 11.4% with major depression have not materially changed since a 2002 review based on 56 publications of mental illness (Fazel, & Danesh, 2002). 4. There were five publications since 2001 that reported rates of comorbidity in prisoners (Assadi et al., 2006; Bermu´ dez, Romero Mendoza, Rodrı´guez Ruiz, Durand-Smith & Saldı´var Herna´ ndez., 2007; Butler & Allnutt., 2003; Duffy, Linehan & Kennedy, 2006, & Piselli, Elisei, Murgia, Quartesan & Abram, 2009).These rates ranged from 20.4 to 43.5% in those with any mental disorder who had comorbid substance misuse, from 13.6 to 95.0% in prisoners with psychotic illnesses with comorbid substance misuse, and 9.2 to 82.5% in individuals with mood disorders and major depression with concurrent substance misuse. 5. A systematic review of 62 surveys of the incarcerated population from 12 Western countries showed that, among the men, 3.7 percent had psychotic illness, 10 percent major depression, and 65 percent a personality disorder, including 47 percent with antisocial personality disorder. Among the women, 4 percent had psychosis, 12 percent major depression, and 42 percent a personality

575

 Chronic Mental Illness in Prisons

disorder. In addition, a significant number suffered from anxiety disorders, including post-traumatic stress disorder (PTSD), organic disorders, short- and long-term sequelae of traumatic brain injury (TBI), suicidal behaviors, distress associated with all forms of abuse, attention deficit hyperactivity disorder (ADHD), and other developmental disorders, including mental retardation and Asperger’s syndrome. Approximately 70 percent had primary or comorbid substance abuse disorders (Tanay, 2007). 6. The suicide rate in prisons is almost 15 times higher than in the general population: in 2002 the rate was 143 per 100,000 compared to 9 per 100,000 in the general population. (The National Service Framework For Mental Health: Five Years On, Department of Health, 2004; Samaritans Information Resource Pack (Mental health foundation-Mental Health Statistics: Prisons).

CAUSES AND EXCERBATION OF PSYCHIATRIC ILLNESS IN PRISON 1. Prisons have high percentage of mentally ill prisoners (Fazel & Danesh, 2002; Assadi et al., 2006; Birmingham, Mason, & Grubin, 1996; Baillargeon, Binswanger, Penn, Williams, & Murray, 2009; James & Glaze, 2006). Firstly, mentally ill persons are more frequently than others involved in crime due to symptoms like impaired judgment, lack of impulse control, suspiciousness, loss of inhibitions, paranoid ideas, inability to trust others, delusions, and hallucinations and most of them are less smart, so easily caught by police. Secondly, prisoner’s living conditions in prison make them more susceptible to psychiatric disorders. Because conditions in prison are not conducive to good mental health, prisoners with mental illness are at risk of experiencing deterioration in their mental state. In 2004, Anderson (Andersen, 2004) pointed in a review that psychiatric morbidity including, schizophrenia is higher and perhaps increasing in prison populations compared with general populations and also with dependence syndromes being the most frequent disorders. He further added that early phase of imprisonment is a vulnerable period with a moderately high incidence of adjustment disorders and twice the incidence in solitary confinement compared with non solitary confinement. Finally, he concluded that there is a growing population of mentally ill prisoners being insufficiently detected and treated. 2. The level of confinement and isolation experienced by some prisoners is detrimental to mental health and people with a pre-existing psychiatric disorder deteriorate, and others who are vulnerable can become psychiatric patients. Long stay of prisoners in prison may be a contributing factor in high number of psychiatric prisoners and vice versa psychiatric persons more involved in unlawful activities and further easily caught by police. Cause for poor mental health of prisoner is overcrowding, very few recreational and intellectual activities and sometimes unnecessary prolongation of under trial period due to lengthy judicial system of hearings (Vinod Kumar & Usha Daria, 2013). 3. Without the necessary care, mentally ill prisoners suffer painful symptoms and their conditions can deteriorate. They are afflicted with delusions and hallucinations, debilitating fears, or extreme mood swings. They huddle silently in their cells, mumble incoherently, or yell incessantly. They refuse to obey orders or lash out without apparent provocation. They beat their heads against cell walls, smear themselves with feces, self-mutilate, and commit suicide. Doing time in prison is hard for

576

 Chronic Mental Illness in Prisons

everyone. Prisoners struggle to maintain their self-respect and emotional equilibrium in facilities that are typically tense, overcrowded, fraught with the potential for violence, cut off from families and communities, and devoid of opportunities for meaningful education, work, or other productive activities. But life in prison is particularly difficult for prisoners with mental illnesses that impair their thinking, emotional responses, and ability to cope. They are more likely to be exploited and victimized by other prisoners. They are less likely to be able to adhere to the countless formal and informal rules of a strictly regimented life and often have higher rates of rule-breaking than other prisoners (Mental Illness, Human Rights, and US Prisons, 2009) 4. Supermaximum Security Prisons and Isolation: When mentally ill prisoners break the rules, officials punish them as they would any other prisoner, even when their conduct reflects the impact of mental illness (Fellner, 2006). If lesser sanctions do not curb the behavior, officials “segregate” the prisoners from the general prison population, placing them in supermaximum security (“supermax”) prisons or in segregation units within regular prisons. Once isolated, continued misconductoften connected to mental illness-can keep them there indefinitely. A disproportionate number of the prisoners in segregation are mentally ill (Lovell, 2008; Maureen, O’Keefe, & Marissa, 2007). Prison officials across the country have increasingly embraced long-term segregation to manage and/or to discipline prisoners who are perceived to be dangerous, but also those who are seen as difficult or disturbing. Supermax prisons such as Tamms Correctional Center in Illinois or segregation units in other prisons constitute the modern day variant of solitary confinement. Prisoners are confined 23 to 24 hours a day in small cells that frequently have solid steel doors. They live with extensive surveillance and security controls, the absence of ordinary social interaction, abnormal environmental stimulus, a few hours a week of “recreation” alone in caged enclosures, and little, if any, educational, vocational, or other purposeful activities. They are handcuffed and frequently shackled every time they leave their cells. Prolonged confinement under such conditions can be psychologically harmful to any prisoner, with the nature and severity of the impact depending on the individual, the duration, and the specific conditions (for example, access to natural light, radio, or books). It can provoke anxiety, depression, anger, cognitive disturbances, perceptual distortions, obsessive thoughts, paranoia, and psychosis (Jeffrey & Dvoskin, 2006). But the risk of harm is particularly grave for prisoners who already have serious mental illnesses. The stress, lack of meaningful social contact, and unstructured days can exacerbate symptoms of illness or provoke a reoccurrence. Suicides occur proportionately more often in segregation units than elsewhere in prison. All too frequently, mentally ill prisoners decompensate in isolation, requiring crisis care or psychiatric hospitalization. Many simply will not get better as long as they are isolated. According to one federal judge, putting mentally ill prisoners in isolated confinement “is the mental equivalent of putting an asthmatic in a place with little air. 5. A comprehensive review of national and international research clearly demonstrates that inmate suicide arises from a complex array of inter-related and self-reinforcing risk factors. These risk factors include mental illness, substance abuse, prior serious suicide attempts, chronic stresses of incarceration (i.e., family separation, solitary confinement, intimidation, and victimization), acute psychosocial stressors (i.e., parole setback, death of a loved one, rape), and staff errors or oversights (Daniel, 2006).

577

 Chronic Mental Illness in Prisons

TREATMENT AND INTERVENTION STRATEGIES 1. A synthesis of the available literature on the management of common mental disorders in prison populations suggests the following approaches in order to address these disorders effectively: a. Assessment for common mental disorders at the point of entry into prison and during imprisonment, particularly during crisis points. b. Admission procedures in individual receiving prisons can be good, but if information from the community or sending prisons is poor or non-existent then the health care professional has to rely on information given by the prisoner. This could be scant or misleading due to the stigma attached to mental health issues. c. Reception is a vital stage for prisoners as they pass into the care and control of the prison Service who take on responsibility for their safety and welfare. The importance of receiving accurate and detailed information about each prisoner, from the courts, other/ prisons, probation, and health services cannot be over-stated. d. Good practice in reception includes: i. Screening everyone carefully ii. Excellent communication between different groups in the prison iii. Continuous availability of mental health specialist care. e. One of the central concerns about the initial screening is the extent to which it relies on selfreported problems. 2. A second concern is the level of training required accurately to assess mental health problems. 3. A third concern is an imbalance between assessment and treatment (Kimmett & Dora, 2009). 4. Induction into prisoners needs to be phased and counselled regarding the life style, rules, regulations and rights of the prisoners. 5. Violence inside prison needs to be kept under check. 6. Prisoner education and information about common mental disorders. 7. Training peers and prison staff to provide support in individual and group settings. 8. Counselling through trained volunteers. 9. Non pharmacological measures to handle sleep problems, psychological symptoms of pain. 10. Adequate recreational activities. 11. Training in problem solving. 12. Counselling. 13. Family Therapy: Family contact can reduce the feelings of isolation and stress caused by imprisonment. Prisons can more effectively meet the needs of prisoners for emotional support, and respond to families in a more consistent way, by: a. Further development of family contact development officers ensuring that families are kept well-informed. b. Involving them in key processes such as sentence planning and suicide prevention. 3. Conferring responsibility for family relations to a specific, accountable person, to coordinate the work with families c. Initiating a family relations working group, with a remit that parallels the work of race relations management teams (Kimmett & Dora, 2009). 14. Cognitive Behavior Therapy.

578

 Chronic Mental Illness in Prisons

15. Professional help using psychotherapeutic methods to validate the distressing experiences, reframing of symptoms, support and counselling. 16. Relaxation techniques such as meditation, yoga, prayers, etc. 17. Stress management programmes (Suresh et al., 2011). Simple measures, including having policies and guidelines for the transfer of severely mentally ill people to psychiatric hospitals, training of prison staff and discharge planning, may improve these rates (Torrey, Kennard, Eslinger, Lamb, & Pavle, 2010).

SHORT COMINGS OF TREATMENT AND INTERVENTON STRATGIES Privatization Because of ever-increasing health care costs, staff expense, lack of qualified health care professionals to work in prisons, lack of visionary correctional leadership (with exceptions), and ever-increasing litigation, more and more states have privatized the mental health and medical services. Contractors range from small private vendors for mental health services with various agreements for staffing and services to large private correctional health care companies providing both medical and mental health care. There are no studies to indicate which model is best suited to deliver adequate, reasonable, and costeffective mental health and psychiatric services in correctional systems: services directly provided by the state; large private vendors providing both medical and mental health services; separate small or large specialist mental health vendors; public medical institutions exclusively; or medical school-private vendor partnership. Appelbaum, Manning and Noonan (2002) have delineated the advantages of the university-state-corporation partnership in Massachusetts. In this model, the state correctional program receives enhanced quality of services, recruitment of high-quality professionals and expansion of training programs, while the medical school expands its revenue source while providing much needed public service as well as opportunities to engage in correctional research (Appelbaum & Noonan, 2002). The profit motive may trump quality and compromise ethics standards and practice. Profit-oriented service providers tend to keep certain key staff positions unfilled or partially filled and encourage less expensive treatment approaches and medications, potentially jeopardizing patient care. Although the experience of private vendors indicates that they are more successful in recruiting professionals, including psychiatrists and psychologists, the correctional system still lags behind other provider systems in attracting qualified personnel. Departments of corrections should develop operational and performance criteria and benchmarks for evaluating vendor compliance. Conducting regular objective and impartial audits with well-designed and valid audit tools would hold the vendors accountable and at the same time help them to take timely corrective action. Once the contract is awarded to a service provider, such entities are become full partners with the state. Communication between the state and the service providers is essential. Key elements of success include establishing credibility and trust. This element should be mutual, in that both entities respect what is agreed on and do not deviate from the established contractual expectations and compliance indicators.

579

 Chronic Mental Illness in Prisons

The Open Formulary vs. Restricted Formulary Controversy Pharmaceutical costs are a significant component of the overall mental health care costs in corrections, and they generally increase about 15 to 20 percent annually. As a result, prescription drugs often become the target of aggressive cost-cutting by private health care providers. A commonly used tactic to control cost is to establish a restricted formulary of older generation psychotropics and generic agents that are less expensive and then insist that the psychiatrist preferentially prescribe medications from this restricted formulary instead of the newer, generally more expensive medications that are often included in the non-formulary list. Control and cost-containment measures are mediated via a concurrent non-formulary review process that is time consuming both for the psychiatrist provider and the psychiatrist reviewer. The reviewer who is employed by the service provider organization is placed in a situation in which he or she must manage the psychopharmacologic practice consistent with accepted standards while trying to control costs to make a profit, sometimes at the expense of quality care. Newer medications improve the quality of life of offenders. More importantly, they help to reduce overall health care costs by reducing long-term hospitalization, emergency admissions to psychiatric units, and indirect costs associated with transportation of offenders to DMH facilities. According to the “Massachusetts Biotechnology Council White Paper Executive Summary” (MBC, 2004) on drug costs: Given that prescription drug costs (10%) are a fraction of health care spending in the U.S. (compared with hospital and physician care: 32 v. 22% respectively), targeting pharmaceuticals to restrain health care cost is questionable as a significant saving mechanism and may in fact cost the health care system dollars if it involves restricting access (MBC, 2004). The irony that cost-saving measures can in fact increase the cost of care may be true of the correctional system as well. Instituting practice parameters and guidelines for prescription practice, stringent peer review, and proper quality-assurance activities, including monitoring long- and short-term side effects should be the preferred method of cost stabilization and control.

Suicide Prevention in Prisons Suicide is the third leading cause of death in U.S. state and federal prisons, exceeded only by natural causes and AIDS. Comprehensive suicide-prevention programs in prisons are of increasing importance to mental health professionals, correctional administrators, health care providers, legislators, attorneys, and others as they seek to rehabilitate offenders and avoid the multimillion-dollar lawsuits that often arise from inmate suicides. A comprehensive review of national and international research clearly demonstrates that inmate suicide arises from a complex array of inter-related and self-reinforcing risk factors (Daniel, 2006).These risk factors include mental illness, substance abuse, prior serious suicide attempts, chronic stresses of incarceration (i.e., family separation, solitary confinement, intimidation, and victimization), acute psychosocial stressors (i.e., parole setback, death of a loved one, rape), and staff errors or oversights. Responsibility for suicide prevention in corrections has traditionally been placed squarely on mental health staff. Experience has shown that their efforts may be doomed to failure in the absence of adequate support and involvement of administrators and custodial staff. These correctional employees have joint responsibility for ensuring the health and safety of prison inmates, and they are increasingly held liable, individually and collectively, when they fail in this duty. Best practice in suicide prevention, outlined in

580

 Chronic Mental Illness in Prisons

the World Health Organization’s updated resource guide (Konrad, Daigle, & Daniel, 2007), calls for a state-of-the-art collaborative effort of administrators, medical and mental health clinicians, and custodial staff to identify at-risk inmates and intervene appropriately.

Pharmacological Treatment for Substance Abuse Inmates being released from prison are particularly vulnerable to serious relapse from the effects of drugs and alcohol within the first month of release (Binswanger, Stern, & Deo, 2007). While in prison, most inmates receive minimal medical treatment for substance abuse, except for detoxification. Longterm relapse prevention is limited to self-help groups, like Alcoholics Anonymous, and therapeutic communities. The overt acute symptoms of withdrawal dissipate within a few days of incarceration. Upon release, substance-abusing offenders return to a cue-rich environment of past drug use that can trigger a powerful rekindling of the addiction. This familiar environment results in the manifestation of physical symptoms similar to acute withdrawal, known as conditioned abstinence, first observed by Abraham Wikler (1973). Conditioned abstinence can occur even before release, when patients recall past drug use, and has been shown in laboratory studies in which exposure of former drug users to drug paraphernalia triggered intense cravings akin to acute drug withdrawal, even though patients had not used drugs for months. Offenders with an established history of drug or alcohol abuse should be treated with anti-craving and relapse-prevention medications two to four weeks before release, and the medication regimen should be continued 30 to 60 days after release. Although there are no medications that treat cocaine, methamphetamine, and marijuana abuse, medications such as naltrexone (Cornish, Metzger, & Woody, 1997) and acamprosate are effective for opioids and alcohol. Naltrexone tablets and the recently approved monthly injection may be well-suited to the correctional setting, unlike methadone. Naltrexone is likely to generate less controversy and problems because it has virtually no potential for abuse or diversion. The availability of newer pharmacotherapy agents to treat addictions ranging from smoking to alcoholism should be aggressively utilized to reduce the unacceptable rate of recidivism.

RECOMMENDATIONS What Can Be Done? The detection, prevention and proper treatment of mental disorders, together with the promotion of good mental health, should be both a part of the public health goals within prison, and central to good prison management. Even in countries with limited resources, steps can be taken that will improve the mental health of prisoners and prison staff, and these steps can be adapted to the cultural, social, political and economic context within that country. •

Divert People with Mental Disorders towards the Mental Health System: Prisons are the wrong place for many people in need of mental health treatment, since the criminal justice system emphasizes deterrence and punishment rather than treatment and care. Legislation can be introduced which allows for the transfer of prisoners to general hospital psychiatric facilities at all stages of the criminal proceedings (arrest, prosecution, trial, imprisonment). For people with 581

 Chronic Mental Illness in Prisons

•

• •

•

•

•

•

582

mental disorders who have been charged with committing minor offences, the introduction of mechanisms to divert them towards mental health services before they reach prison will help to ensure that they receive the treatment they need and also contribute to reducing the prison population. The imprisonment of people with mental disorders due to lack of public mental health service alternatives should be strictly prohibited by law. Provide Prisoners with Access to Appropriate Mental Health Treatment and Care: Access to assessment, treatment, and (when necessary) referral of people with mental disorders, including substance abuse, should be an integral part of general health services available to all prisoners. The health services provided to prisoners should, as a minimum, be of an equivalent level to those in the community. This may be achieved by providing mental health training to prison health workers, establishing regular visits of a community mental health team to prisons, or enabling prisoners to access health services outside the prison setting. Those requiring more specialist care for example, can be referred to specialist mental health providers where inpatient assessment and treatment can be provided. Primary health care providers in prisons should be provided with basic training in the recognition and basic management of common mental health disorders. Provide Access to Acute Mental Health Care in Psychiatric Wards of General Hospitals: When prisoners require acute care they should be temporarily transferred to psychiatric wards of general hospitals with appropriate security levels. Ensure the Availability of Psychosocial Support and Rationally Prescribed Psychotropic Medication: Prisoners, through appropriately trained health care providers - should have the same access to psychotropic medication and psychosocial support for the treatment of mental disorders as people in the general community. Provide Training to Staff: Training on mental health issues should be provided to all people involved in prisons including prison administrators, prison guards and health workers. Training should enhance staff understanding of mental disorders, raise awareness on human rights, challenge stigmatizing attitudes and encourage mental health promotion for both staff and prisoners. An important element of training for all levels of prison staff should be the recognition and prevention of suicides. In addition, prison health workers need to have more specialized skills in identifying and managing mental disorders. Provide Information/Education to Prisoners and Their Families on Mental Health Issues: Prisoners and their families should receive information and education on the nature of mental disorders, with a view to reducing stigma and discrimination, preventing mental disorders and promoting mental health. Information can help prisoners and their families better understand their emotional responses to imprisonment and provide practical strategies on how to minimize the negative effects on their mental health and inform them as to when and how to seek help for a mental disorder. Promote High Standards in Prison Management: The mental health of all prisoners, including those with mental disorders, will be enhanced by appropriate prison management that promotes and protects human rights. Attention to areas such as sanitation, food, meaningful occupation, and physical activity, prevention of discrimination and violence, and promotion of social networks are essential. Ensure that the Needs of Prisoners Are Included in National Mental Health Policies and Plans: National mental health policies and/or plans should encompass the mental health needs of the prison population. Where, policies and plans fail to do so it may be necessary to advocate

 Chronic Mental Illness in Prisons

•

•

•

for their inclusion. Whenever a mental health policy or plan is being developed, prisons (staff and prisoners) should be included as stakeholders in the development process. Promote the Adoption of Mental Health Legislation That Protects Human Rights: All prisoners, including those with mental disorders, have the right to be treated humanely and with respect for their inherent dignity as human beings. Furthermore, conditions of confinement in prisons must conform to international human rights standards. Mental health legislation can be a powerful tool to protect the rights of people with a mental disorder, including prisoners, yet in many countries mental health laws are outdated and fail to address the mental health needs of the prison population (WHO Resource Book on Mental Health, Human Rights and Legislation; WHO, 2005 & WHR, 2001).The development of legal provisions that address these needs can help to promote the rights of prisoners, including the right to quality treatment and care, to refuse treatment, to appeal decisions of involuntary treatment, to confidentiality, to protection from discrimination and violence, and to protection from torture and other cruel, inhuman and degrading treatment (including abusive use of seclusion, restraints and medication, and non-consensual scientific or medical experimentation), among others. Legislation should provide prisoners with mental disorders with procedural protections within the criminal justice system equivalent to those granted other prisoners. The protections, through legislation, of other basic rights of prisoners, such as acceptable living conditions, adequate food and access to the open air, meaningful activity, and contact with the family are also important and can further contribute to the promotion of good mental health. Independent inspection mechanism such as mental health visiting boards can also be established through legislation, to inspect prisons as well as other mental health facilities in order to monitor conditions for people with mental disorders. Encourage Inter-Sectoral Collaboration: Many problems and issues can be solved by bringing relevant Ministries and others together to discuss the needs of prisoners with mental health disorders. Different stakeholders should meet to discuss mental health in prisons and to plan an inter-sectoral response (WHO Resource Book on Mental Health, Human Rights and Legislation). Social Reintegration: Often understood as the support given to offenders during their reentry into society following imprisonment. A broader definition, however, encompasses a number of interventions undertaken following an arrest to divert offenders away from the criminal justice system to an alternative measure, including a restorative justice process or suitable treatment. It includes imposing community-based sanctions rather than imprisonment in an attempt to facilitate the social reintegration of offenders within the community, rather than subjecting them to the marginalizing and harmful effects of imprisonment. For those who are sentenced to imprisonment, it includes correctional programs in prison, and aftercare interventions (World Drug Report, 2006). In recent years, the post-release, community-based component of these interventions has been variously referred to as “aftercare”, “transitional care”, “reentry” or “reentry support”, reintegration, or resettlement. Some post-release interventions may begin while the offender is still incarcerated with the intent of facilitating post-release adjustment.

Programs to Support and Assist for Mentally Ill Offenders Offenders afflicted by mental illness encounter particular problems upon release into the community. These offenders may experience extreme social isolation and, as well, are often at risk for a co-occurring substance abuse disorder. As well, these offenders may encounter particularly difficulties in finding 583

 Chronic Mental Illness in Prisons

suitable accommodation and securing employment. And, it is likely that most of these offenders will require further medical and therapeutic services and assistance with money management. These factors, in combination with noncompliance of treatment orders, may make these individuals a risk not only to themselves, but to others as well (Hartwell & Orr, 1999). The unique challenges faced by mentally ill offenders upon release require the development of a community-based treatment model of continuing care to address the risks, needs, and vulnerabilities of this offender group. Community-based treatment models of continuing care may reduce the risk to the public, for the individual offenders and reduce future correctional system involvement for these individuals, in addition to providing a diversion program from the traditional justice system (Griffiths, 2004; Hartwell & Orr, 2004). Research has identified continuity of care as an essential component of effective mental health treatment for mentally ill persons who are involved in the criminal justice system. This includes multidisciplinary case management for psychiatric treatment and social services, e.g. housing, food, help with disability benefits, and vocational training. Forensic mental health professionals have identified the core components of any intervention designed to assist mentally ill offenders to successfully re-enter the community, these include; 1. A focus on stabilizing the offender’s illness; 2. Enhancing their independent functioning; 3. Maintaining their internal and external controls so as to minimize the likelihood they will act violently and commit new offences; 4. Establishing a liaison between treatment staff and the justice system; 5. Providing structure in the offender’s daily life; 6. Using authority comfortably; 7. Managing the offender’s violence and impulses; 8. Integrating treatment and case management; 9. Obtaining therapeutic living arrangements; and, 10. Working with the offender’s family to determine if they are a reliable source of social support (Griffiths, Dandurand, & Murdoch, 2007).

CONCLUSION The psychiatric morbidity among prison inmates is substantially higher than in the general population. Most inmates have a number of defined problem areas, with substance use, depression and anxiety disorders most prevalent. The high rate of common psychiatric disorders argues for the use of improved psychiatric screening instruments, improved assessment and treatment capacities in the prison and an increased number of psychiatric inpatient facilities to care for the inmates who are too unwell to be treated in the prison. The burden of psychiatric illness in this vulnerable and marginalized population poses a serious challenge. For remedial measures to be taken identification of magnitude of problem, preventable causes and treatment with proper compliance and follow-up is needed. Mental disorders are highly stigmatized conditions that many people want to keep private because of their embarrassment or fear of discrimination. Certain remedial measures are to be implemented for a better future of prison and community because ultimately these prisoners will be released from prison and become a part of community. Beginning of reforms is the immediate need as a long journey ahead. 584

 Chronic Mental Illness in Prisons

REFERENCES Agbahowe, S. A., Ohaeri, J. U., Ogunlesi, A. O., & Osahon, R. (1998). Prevalence of psychiatric morbidity among convicted inmates in a Nigerian prison community. East African Medical Journal, 75(1), 19–26. PMID:9604530 Andersen, H. S. (2004). Mental health in prison populations. A review – With special emphasis on a study of Danish prisoners on remand. Acta Psychiatrica Scandinavica, 424(s424), 5–59. doi:10.1111/j.16000447.2004.00436_2.x PMID:15447785 Anderson, H. S., Sestoft, D., Lillebaek, T., Gabrielsen, G., Hemmingsen, R., & Kramp, P. (2000). A longitudinal study of prisoners on remand: Psychiatric prevalence, incidence and psychopathology in solitary vs non-solitary confinement. Acta Psychiatrica Scandinavica, 102(1), 19–25. doi:10.1034/j.16000447.2000.102001019.x PMID:10892605 Appelbaum, K. L., Manning, T. D., & Noonan, J. D. (2002). A university-state-corporation partnership for providing correctional mental health services. Psychiatric Services (Washington, D.C.), 53(2), 185–189. doi:10.1176/appi.ps.53.2.185 PMID:11821549 Assadi, S. M., Noroozian, M., Pakravannejad, M., Yahyazadeh, O., Aghayan, S., Shariat, S. V., & Fazel, S. (2006). Psychiatric morbidity among sentenced prisoners: Prevalence study in Iran. The British Journal of Psychiatry, 188(2), 159–164. doi:10.1192/bjp.188.2.159 PMID:16449704 Baillargeon, J., Binswanger, I. A., Penn, J. V., Williams, B. A., & Murray, O. J. (2009). Psychiatric disorders and repeat incarcerations: The revolving prison door. The American Journal of Psychiatry, 166(1), 103–109. doi:10.1176/appi.ajp.2008.08030416 PMID:19047321 Baillargeon, J., Penn, J. V., Thomas, C. R., Temple, J. R., Baillargeon, G., & Murray, O. J. (2009). Psychiatric disorders and suicide in the nation’s largest state prison system. The Journal of the American Academy of Psychiatry and the Law, 166(1), 103–109. doi:10.1176/appi.ajp.2008.08030416 PMID:19535556 Bermu´dez, C.E., Romero Mendoza, M.P., Rodrı´guez Ruiz, E.M., Durand-Smith, A.L., & Saldı´var Herna´ndez, G.J. (2007). Female depression and substance dependence in the Mexico City penitentiary system. Academic Press. Binswanger, I. A., Stern, M. F., & Deo, R. A. (2007). Release from prison: A high risk of death for former inmates. Cross Ref Medline, 356, 157–165. PMID:17215533 Birmingham, L., Mason, D., & Grubin, D. (1996). Prevalence of mental disorder in remand prisoners: Consecutive case study. British Medical Journal, 313(7071), 1521-4. Brinded, P. M., Simpson, A. I. F., Laidlaw, T. M., Fairley, N., & Malcolm, F. (2001). Prevalence of psychiatric disorders in New Zealand prisons: A national study. The Australian and New Zealand Journal of Psychiatry, 35(2), 166–173. doi:10.1046/j.1440-1614.2001.00885.x PMID:11284897 Brownell, B. (2014). Crime and Justice, Health Care, Human Rights, Prisons, op Stories, There Are 10 Times More Mentally Ill People Behind Bars Than in State Hospitals. Academic Press.

585

 Chronic Mental Illness in Prisons

Brugha, T., Singleton, N., Meltzer, H., Bebbington, P., Farrell, M., Jenkins, R., ... Lewis, G. (2005). Psychosis in the community and in prisons: A report from the British National Survey of psychiatric morbidity. The American Journal of Psychiatry, 162(4), 774–780. doi:10.1176/appi.ajp.162.4.774 PMID:15800152 Butler, T., & Allnutt, S. (2003). Mental Illness among New South Wales Prisoners. NSW Correction Health Service. Butler, T. K., Males, J. J., Robinson, L. P., Wechsler, A. W., Sutton, G. L., Cheng, J., ... McClellan, K. (1997). Six-year review of Acanthamoeba keratitis in New South Wales, Australia: 1997-2002. Clinical & Experimental Ophthalmology, 33(1), 41–46. doi:10.1111/j.1442-9071.2004.00911.x PMID:15670077 California Department of Corrections and Rehabilitation Report. (2014). Unless otherwise noted, all data in this report were provided by the For purposes of this report, “mental illness” is defined as a condition that qualifies for placement in the prison’s Mental Health Delivery System within the last year. Academic Press. Coid, J. (1984). How many psychiatric patients in prison? The British Journal of Psychiatry, 145(1), 78–86. doi:10.1192/bjp.145.1.78 PMID:6743949 Cornish, J. W., Metzger, D., Woody, G. E., Wilson, D., McLellan, A. T., Vandergrift, B., & O’Brien, C. P. (1997). Naltrexone pharmacotherapy for opioid dependent federal probationers. Journal of Substance Abuse Treatment, 14(6), 529–534. doi:10.1016/S0740-5472(97)00020-2 PMID:9437624 Daniel, A. E. (2006). Preventing suicide in prison: A collaborative responsibility of administrative, custodial, and clinical staff. The Journal of the American Academy of Psychiatry and the Law, 34(2), 165–175. PMID:16844795 Doris, J. J., & Lauren, E. G. (2006). Mental Health Problems of Prison and Jail Inmates. Bureau of Justice Statistics. Duffy, D., Linehan, S., & Kennedy, H.G. (2006). Psychiatric morbidity in the male sentenced Irish prisons population. Academic Press. Fazel, S., Cartwright, J., Norman-Nott, A., & Hawton, K. (2008). Suicide in prisoners: A systematic review of risk factors. The Journal of Clinical Psychiatry, 69(11), 1721–1731. doi:10.4088/JCP.v69n1107 PMID:19026254 Fazel, S., & Danesh, J. (2002). Serious mental disorder in 23 000 prisoners: a systematic review of 62 surveys. Severe mental illness in 33 588 prisoners worldwide: systematic review and meta regression analysis. Lancet, 359(9306), 545–550. doi:10.1016/S0140-6736(02)07740-1 PMID:11867106 Fazel, S., & Seewald, K. (2012). Severe mental illness in 33,588 prisoners worldwide: Systematic review and meta-regression analysis. The British Journal of Psychiatry, 200(5), 364–373. doi:10.1192/ bjp.bp.111.096370 PMID:22550330 Fazel, S., & Yu, R. (2011). Psychotic disorders and repeat offending: Systematic review and meta-analysis. Schizophrenia Bulletin, 37(4), 800–810. doi:10.1093chbulbp135 PMID:19959703 Fellner, J. (2006). A Corrections Quandary. Harvard Civil Rights-Civil Liberties Law, 29, 773–789.

586

 Chronic Mental Illness in Prisons

Griffiths, C. T., Dandurand, Y. V., & Murdoch, D. (2007). The Social Reintegration of Offenders and Crime Prevention- The International Centre for Criminal Law Reform and Criminal Justice Policy. ICCLR. Hartwell, S. W., & Orr, K. (1999, September). The massachusetts forensic transition program for mentally ill offenders reentering the community. Psychiatric Services (Washington, D.C.), 50(9), 1220–1222. doi:10.1176/ps.50.9.1220 PMID:10478911 Holley, H. L., Arboleda, F. J., & Love, E. (1995). Lifetime prevalence of prior suicide attempts in a remanded population and relationship to current mental illness. International Journal of Offender Therapy and Comparative Criminology, 10(2), 239–256. James, D.J., & Glaze, L.E. (2006). Mental health problems of prison and jails inmates. U.S. Dept. of Justice: Office of Justice Programs. Jeffrey, M., & Dvoskin, J. (2006). An overview of correctional psychiatry. The Psychiatric Clinics of North America, 29, 773–789. PMID:16904511 Jha, B. K. (1968). A study of the nature of criminal offences of mental patients. Indian Journal of Psychiatry, 10(1), 166–176. Kariminia, A., Law, M., Butler, T., Corben, S. P., Levy, M. H., Kaldor, J. M., & Grant, L. (2007). Factors associated with mortality in a cohort of Australian prisoners. European Journal of Epidemiology, 22(7), 417–428. doi:10.100710654-007-9134-1 PMID:17668280 Kimmett, E., & Dora, R. (2009). An independent review of unmet mental health need in prison. Prison Reform Trust. Konrad, N., Daigle, M. S., & Daniel, A. E. (2007). Preventing suicide in jails and prisons. Geneva: World Health Organization. Kumar, V., & Daria, U. (2013). Psychiatric morbidity in prisoners. Indian Journal of Psychiatry, 55(4), 366–370. doi:10.4103/0019-5545.120562 PMID:24459308 Los Angeles Times. (2010). Sheriff says proposed mental health cuts would burden L.A. jails. Los Angeles Times. Lovell, D. (2008). Patterns of disturbed behavior in a supermax prison. Criminal Justice and Behavior, 35(8), 985–1004. doi:10.1177/0093854808318584 Maden, A., Swinton, M., & Gunn, J. (1992). A survey of pre-arrest drug use in sentenced prisoners. British Journal of the Addictions, 87, 27-33. Mason, D., Birmingham, L., & Grubin, D. (1997). Substance use in remand prisoners: A consecutive case study. British Medical Journal, 315(7099), 8–21. doi:10.1136/bmj.315.7099.18 PMID:9233320 Massachusetts Biotechnology Council. (2004). White paper executive summary on prescription drug cost, access and affordability. Cambridge, MA: Author. Maureen, L. (2007). Offenders with mental illness in the correctional system. Journal of Offender Rehabilitation, 45(1-2), 81–104. doi:10.1300/J076v45n01_08

587

 Chronic Mental Illness in Prisons

Mencimer, S. (2014). Crime and Justice, Health Care, Human Rights, Prisons, Top Stories. There Are 10 Times More Mentally Ill People Behind Bars Than in State Hospitals. Academic Press. Mental Illness, Human Right, and US Prisons. (2009). Human Rights Watch Statement for the Record to the Senate Judiciary Committee Subcommittee on Human Rights and the Law. Author. Mohan, C., & Dhar, V. (2001). Study of psychiatric status of Central Jail under trials at psychiatric hospitals, Government Medical College, Jammu. Indian Journal of Psychiatry, 43, 59. Naidoo, S., & Mkize, D.L. (2012). Prevalence of mental disorders in a prison population in Durban, South Africa. African Journal of Psychiatry, 15(1). Piselli, M., Elisei, S., Murgia, N., Quartesan, R., & Abram, K. M. (2009). Co-occurring psychiatric and substance use disorders among male detainees in Italy. International Journal of Law and Psychiatry, 29, 370–385. PMID:19237198 Prison Statistics India. (2012). Prison Statistics India is the eighteenth in the series of annual publication. The National Crime Records Bureau, Ministry of Home Affairs. Report, W. H. (2001). Mental Health: New Understanding, New Hope. Geneva: World Health Organization. Sandeep, K. G., Paramjit, S., Parshotam, D. G., Samta, G., & Aseem, G. (2011). Psychiatric morbidity in prisoners. Indian Journal of Psychiatry, 53(3), 253–257. doi:10.4103/0019-5545.86819 PMID:22135446 Singh, G., & Verma, H. C. (1976). Murder in Punjab: A psychosocial study. Indian Journal of Psychiatry, 18, 243–251. Singleton, N., Meltzer, H., & Gatward, R. (1998). Psychiatric Morbidity among Prisoners in England and Wales. London: Stationery Office. Somsundram, O. (1974). Crimes of persons with schizophrenia. Indian Journal of Psychiatry, 16(2), 121–130. Somsundram, O. (1997). Crimes of persons with affective disorders. Indian Journal of Psychiatry, 39, 13–17. PMID:21584037 Steadman, H. J., Fabisiak, S., Dvoskin, J., & Holohean, E. J. (1987). Jr A survey of mental disability among state prison inmates. Hospital & Community Psychiatry, 38(10), 1086–1090. PMID:3666699 Suresh, B. M., Pratima, M., Rajani, P., Naveen, K. C., & Madhusudhan, S. (2011). Minds Imprisoned: Mental Health Care in Prisons. Publication, National Institute of Mental Health Neuro Sciences. Bangalore: Common Mental Disorders in Prisons. Tanay, E. (2007). Virginia Tech mass murder: A forensic psychiatrist’s perspective. The Journal of the American Academy of Psychiatry and the Law, 35, 152–153. PMID:17592159 Torrey, E., Kennard, A., Eslinger, D., Lamb, R., & Pavle, J. (2010). More Mentally Ill Persons are in Jails and Prisons than Hospitals: A Survey of the States. Treatment Advocacy Center. Walmsley, R. (2005). The World Female Imprisonment. The International Centre for Prison Studies (ICPS).

588

 Chronic Mental Illness in Prisons

Walmsley, R. (2009). World Prison Population List (8th ed.). King’s College London International Centre for Prison Studies. WHO. (2005). Resource Book on Mental Health, Human Rights and Legislation. World Health Organization. Wikler, A. (1973). Dynamics of drug dependence: Implications of a conditioning theory for research and treatment. Archives of General Psychiatry, 28(5), 611–616. doi:10.1001/archpsyc.1973.01750350005001 PMID:4700675 World Drug Report. (2006). Retrieved 9 February, 2016, from https://www.unodc.org/unodc/en/dataand-analysis/WDR-2006.html

KEY TERMS AND DEFINITIONS Incarceration: Putting in prison or another enclosure. Mental Health: Emotional, psychological and social well-being. Mental Illness: Refers to wide range of mental health conditions –disorders that affect mood, thinking and behaviour. Prison: Place were prisoners reside called a prison, jail or detention center. Prisoners: All persons detained, incarcerated or imprisoned in a facility on the basis of, or allegation of, a criminal offence in prisons.

This research was previously published in Chronic Mental Illness and the Changing Scope of Intervention Strategies, Diagnosis, and Treatment edited by Barre Vijaya Prasad, pages 203-224, copyright year 2017 by Medical Information Science Reference (an imprint of IGI Global).

589

Section 9

Nerve Disorders and Pain Management

591

Chapter 29

Medical Management of Trigeminal Neuralgia Niushen Zhang Stanford University, USA

ABSTRACT The first-line treatment of trigeminal neuralgia can be very effective, but side effects are often difficult for patients to tolerate. This chapter is a guide to the broad selection of medical therapies currently available for the treatment of trigeminal neuralgia which includes oral therapies and other non-surgical methods of treatment such as IV medications, nasal sprays, topical ointments, and injections. The discussion of each treatment includes discussion of its evidence in current literature, its proposed mechanism of action, its dosing and appropriate setting for clinical use, and its side effect profile.

INTRODUCTION The aim of all trigeminal neuralgia therapies is to modulate the hyperexcitable state of the trigeminal afferents to relieve pain. The first-line treatment of trigeminal neuralgia is oral medication. These medications can be very effective for the treatment of trigeminal neuralgia, but their side effects are often difficult for patients to tolerate. If a patient fails first and second line oral therapies, and if the patient is not a surgical candidate, then the wide array of next-line oral medications and combination therapy should be considered. In addition, there has been exploration into other non-surgical and non-invasive methods of treatment such as IV medications, nasal sprays, topical ointments, and injections. This chapter is a guide to the broad selection of medical therapies currently available for the treatment of trigeminal neuralgia. For each treatment, this chapter will cover multiple aspects including 1) discussion of its evidence in current literature; 2) its proposed mechanism of action; 3) its dosing and appropriate setting for clinical use; and 4) its side effect profile.

DOI: 10.4018/978-1-5225-7122-3.ch029

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Medical Management of Trigeminal Neuralgia

PART 1: FIRST-LINE THERAPY Treatment of trigeminal neuralgia should begin with either carbamazepine or with oxcarbazepine, as agreed upon by the American Academy of Neurology and the European Federation of Neurological Societies (Cruccu & Truini, 2013). When a patient does not respond to either carbamazepine or oxcarbazepine, or if the patient cannot take these medications because of contraindications or intolerable side effects, then the patient is defined as having refractory trigeminal neuralgia (Cruccu, 2013).

Carbamazepine Carbamazepine has level A evidence and is the first line therapy for initial and long-term treatment of trigeminal neuralgia (Gronseth et al., 2008; Chesire, 2015). Patients who respond to the medication will often experience pain relief within a few days of starting carbamazepine. However, this medication should be used cautiously, especially in the elderly, because of its many side effects. Carbamazepine’s mechanism for pain relief is unknown. It is an iminostilbene whose structure resembles tricyclic antidepressants and phenytoin. One hypothesis is that it decreases conductance in sodium channels, which results in stabilization of hyper excitable membranes and inhibits ectopic discharges (Tremont-Lukats, Megeff, & Backonja, 2000). The medication usually reaches peak concentration in 2-6 hours. After 2-4 weeks of starting carbamazepine, the half-life decreases from about 30 hours to 13-17 hours because of auto-induction. The drug is excreted by the liver. As an anticonvulsant, the therapeutic drug level is 4-12 mcg/dl. In the context of treating trigeminal neuralgia, there is poor correlation between pain relief and drug concentration (Green & Selman, 1991). Carbamazepine is the best studied medical treatment for trigeminal neuralgia. There are four, high quality (Class I or II), placebo-controlled studies demonstrating that carbamazepine can, not only reduce the frequency and intensity of painful episodes, but is equally efficacious for spontaneous and triggerevoked attacks (Gronseth et al., 2008). The dose range for carbamazepine in these studies was 300mg to 2,400mg daily. The treatment response in these trials were very strong, with 58-100% of patients on carbamazepine experiencing complete or near complete pain control, compared to 0-40% of patients on placebo experiencing complete or near complete pain control (Jorns & Zakrzewska, 2007). However, there has only been one study that evaluated the long-term efficacy of carbamazepine over a 16-year period. In this study of 146 patients, there was an initial reported success in 60% of patients. But by 5-16 years, only 22% of participants were still experiencing benefit from carbamazepine. About 44% of patients required additional or alternative treatment (Taylor, Brauer, & Espir, 1981). Observational studies have shown that there is a decrease in efficacy over time, but this may be related more to increased severity of the disease rather than development of tolerance (Zakrzewska & Patsalos, 2002). Carbamazepine should not be used in patients with a history of bone marrow depression or hypersensitivity to tricyclic compounds such as amitriptyline and nortriptyline (Ferrell & McLeod, 2008). Also, before starting carbamazepine, it is imperative to evaluate the patient’s risk for potentially developing carbamazepine-induced Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). Though the occurrence is rare, SJS and TEN are two forms of the same life-threatening skin disease that can cause rash, skin peeling, and sores on the mucous membranes. The HLA-B*1502 allele is highly associated with carbamazepine-induced SJS and TEN. The association has been found mostly in the Han Chinese. The association has not been found in Caucasian patients. The HLA-B*1502 allele frequency is 10.2% in Han Chinese living in Asia and 5% in Asians living in North America (Ferrell & McLeod, 592

 Medical Management of Trigeminal Neuralgia

2008). There is a 0.25% (1 in 400) incidence of carbamazepine-induced SJS and TEN in Taiwan. Though the positive predictive value of the test is low, the FDA recommends genotyping all Asian patients for the allele. It is most likely prudent to avoid carbamazepine when patients have tested positive given the availability of other effective medications (Ferrell & McLeod, 2008). Carbamazepine is usually prescribed as extended-release capsules or tablets. It is available as 200mg tablets, 100mg chewable tablets, and suspension of 100mg/5mL. The usual starting dose is 200mg daily or divided into two doses. For elderly patients and for patients who are particularly sensitive to medication side effects, carbamazepine can be started at 100mg daily. Some patients may experience pain relief with doses as small as 100mg twice to three times a day. Otherwise, the daily dose can be increased by 100mg every 3-4 days until adequate pain relief is achieved, or until the patient experiences any intolerable side effects. The typical maintenance dose range is from 200mg to 1200mg per day, divided into two to four doses (Obermann, 2010). For some patients, frequent dosing can be helpful for breakthrough pain that occurs between doses (Tomson & Ekbom, 1981). Initial efficacy is approximately 80% (Obermann, 2010). As mentioned above, over time, larger doses are typically required to maintain pain control. Carbapamezapine is typically recommended as daily preventive therapy, but based on clinical experience, some patients are able to successfully use carbamazepine as rescue therapy and only take it as needed. There are also patients who take a consistent daily dose but will take additional dose (such as 200mg) on an as needed basis. Approximately 6-10% of patients cannot tolerate carbamazepine (Taylor et al., 1981). Many of the side effects are dose dependent. Dizziness, lightheadedness, drowsiness, ataxia, diplopia, nystagmus, nausea and vomiting are some of the common side effects. Less common side effects include hypertension, paresthesia, blurred vision, hyponatremia, and increase in transaminases. Rare, but potentially serious side effects include allergic rash, myelosuppression, hepatotoxicity, lymphadenopathy, systemic lupus erythematosus, Stevens-Johnson syndrome, and aplastic anemia (Jorns & Zakrzewska, 2007). Within several weeks after starting the medication, labs for serum sodium, complete blood count, and liver function test should be performed. Carbamazepine also has multiple pharmacologic interactions. It is a CYP450 inducer and may increase clearance and lead to sub-therapeutic levels of many drugs including warfarin, anti-epileptic drugs and mood stabilizers (lamotrigine, phenytoin, valproic acid), benzodiazepines, and birth control pills.

Oxcarbazepine Oxcarbazepine is a keto-derivative of carbamazepine that has simpler pharmacokinetics. The weaker induction of hepatic enzymes is thought to lead to a better side effect profile compared to carbamazepine. It is predominantly excreted by the kidneys. Patients who are allergic to carbamazepine may also be allergic to oxcarbazepine. Genotyping before primary oxcarbazepine treatment has neither been recommended nor studied. However, Oxcarbazepine is not recommended for patients who are HLA-B*1502 positive because there are reports of cross-reactivity for skin reactions in patients who were already intolerant to carbamazepine (Ferrell & McLeod, 2008). Although carbamazepine has stronger evidence for efficacy, oxcarbazepine has a better safety profile (Beydoun, 2000). There is one double-blind, crossover trial (Liebel, Menger, & Langohr, 2001). and three multi-center, double-blind, randomized trials comparing efficacy and tolerability of oxcarbazepine (900-2100mg/day) vs. carbamazepine (400-1200mg/day) in patients with trigeminal neuralgia (Beydoun, Schmidt, & D’Souza, 2002). These trials showed a comparable analgesic effect between the two 593

 Medical Management of Trigeminal Neuralgia

treatments which has led to the conclusion that oxcarbazepine can be used as an effective alternative to carbamazepine for the treatment of trigeminal neuralgia. Oxcarbazepine was found to have significantly fewer adverse effects than carbamazepine, especially fewer incidences of dizziness, ataxia, and fatigue (Jorns & Zakrzewska, 2007). Oxcarbazepine is available as 150mg, 300mg, and 600mg film-coated tablets. It is also available as a 60mg/mL oral suspension. Starting dose is usually 150mg twice daily. But similar to carbamazepine, it is prudent and reasonable to start at 150mg daily for elderly patients and patients known to be sensitive to medication side effects. If 150mg once a day is tolerated, then increase as tolerated by 150mg every three to four days. The typical maintenance dose is 300-600mg twice a day. Effective dose range is 1200-2400mg each day. In one study, onset of the effect was observed within 24 hours (Zakrzewska & Patsalos, 1989). Common side effects include nausea, vomiting, dizziness, fatigue, tremors. Higher doses (>28-35mg/kg/day) can lead to mild hyponatremia. Similar to carbamazepine, within several weeks after starting oxcarbazepine, labs for serum sodium, complete blood count, and liver function test should be performed.

PART 2: SECOND-LINE THERAPY Existing evidence has shown that patients who are resistant to a therapeutic dose of carbamazepine or oxcarbazepine will most likely not benefit from another orally administered medication. But many patients simply cannot reach the therapeutic dosage because of intolerance to adverse effects. Second-line therapies are typically add-on therapies but can be used on their own if carbamazepine and oxcarbazepine are contraindicated or cause intolerable side effects, even at low doses.

Baclofen Baclofen is most commonly used to relieve muscle spasticity. The analgesic effect of the drug has been found to be independent from the impairment of motor activity (Levy & Proudfit, 1977). Baclofen is a GABAB receptor agonist and acts by decreasing excitatory neurotransmission, and therefore, may facilitate segmental inhibition of the trigeminal complex (Green & Selman, 1991). Some data, from in vitro studies, show that baclofen exhibits antagonistic properties against substance P (Saito, Konishi, & Otsuka, 1975). Baclofen reaches peak blood levels in about 2 hours and has a half-life of about 3.5 hours. Within 24 hours after a single dose, more than 85% is excreted unchanged by the kidney (Terrence & Fromm, 1981). There are several trials from the 1980’s that examine the efficacy of baclofen but these were small studies with poor methodology. In some of the trials, baclofen was used as monotherapy, and in others, baclofen was an add-on therapy (Parekh, Shah, Kotdawalla, & Gandhi, 1989). In a double-blind study, baclofen was effective in 70% of patients at doses of 10-60mg per day (Fromm, Terrence, & Chattha, 1984). Over one to five years of follow-up of 60 patients, the efficacy was only maintained in 30% of patients and 17% experienced recurrence of pain within 3-6 months, and 22% became refractory after 1-18 months. A second study by the same group compared carbamazepine alone, baclofen and carbamazepine, and baclofen only. They found the combination therapy appeared to give the best results (Fromm & Terrence, 1987).

594

 Medical Management of Trigeminal Neuralgia

Baclofen is most often used in combination with carbamazepine or oxcarbazepine. The starting dose is 5mg twice to three times a day. The dose can be increased by 5-10mg each week. The usual dose taken for maximum pain relief is between 50-60mg per day, divided into three doses. Drowsiness, dizziness, confusion and lethargy, abdominal symptoms. It is important to note that in patients taking baclofen on a long-term basis (many months or more), abrupt discontinuation of baclofen can cause withdrawal seizures and hallucinations. In the cases reported, patients were on 80mg daily or greater. After many months of use, it is strongly advised that baclofen should be gradually tapered by 5-10mg each week. If withdrawal symptoms occur, then the dosage should be raised to prior levels and then resume gradual taper once patient is stable (Terrence & Fromm, 1981).

Lamotrigine Lamotrigine is best known for its antiepileptic and mood stabilizing properties. Lamotrigine can also be a useful medication to treat trigeminal neuralgia. It is often used as adjunctive therapy to carbamazepine and oxcarbazepine or as monotherapy. Lamotrigine is thought to stabilize neural membranes and inhibits the release of excitatory neurotransmitters by acting on voltage-sensitive sodium channels (Obermann, 2010). The data for Lamotrigine as add-on therapy has shown mixed results. In a double-blind placebo controlled trial of lamotrigine in combination with other medications (such as gabapentin) for neuropathic pain, Lamotrigine did not show any superiority over placebo in any of the endpoints (Silver, Blum, Grainger, Hammer, & Quessy, 2007). In a small, double-blind, placebo-controlled trial, lamotrigine 400mg daily, as an add-on therapy, was beneficial and more effective than placebo in fourteen patients with trigeminal neuralgia who were refractory to carbamazepine (Zakrzewska, Chaudhry, Nurmikko, Patton, & Mullens, 1997). As for using lamotrigine as monotherapy, there have been previous studies (Canavero & Bonicalzi, 1997), as well as, several more recent studies that have shown promising results. In a crossover trial of lamotrigine vs. carbamazepine, patients were titrated to lamotrigine 400mg and carbamazepine 1,200mg (Shaikh, Yaacob, & Abd Rahman, 2011). Out of a total of twenty-one patients, 62% attained pain relief from lamotrigine and over 90% attained pain relief from carbamazepine. But a greater proportion of patients obtained a complete and greater degree of pain relief with lamotrigine than with carbamazepine. In an open-label study, eleven out of fifteen patients with trigeminal neuralgia experienced pain relief with 400mg of lamotrigine (Lunardi et al., 1997). In another open label study, lamotrigine was compared with carbamazepine in the efficacy of relieving trigeminal neuralgia pain in eighteen multiple sclerosis (Leandri et al., 2000). These patients were experiencing little or no relief from carbamazepine and could not tolerate the additional CNS side effects from carbamazepine, in addition to their baseline neurological impairments. The patients were tapered off of carbamazepine and were started on a gradual lamotrigine titration. Seventeen out of eighteen patients had complete or nearly complete pain relief on lamotrigine at doses between 75-400mg per day. Patients were much less drowsy on lamotrigine. Lamotrigine is available as 25mg, 100mg, 150mg, and 200mg tablets. Chewable dispersible tablets and orally disintegrating tables are also available. Because of potential risk for Stevens Johnson Syndrome, a slow titration is recommended. The slower the titration, the less likely that these side effects will occur (Ketter et al., 2005; Obermann, 2010). The recommended starting dose is 25mg daily for one week, then it can be increase by 25mg daily every week until reaching the therapeutic dose range of 200

595

 Medical Management of Trigeminal Neuralgia

to 400mg daily. Understandably, some patients find it difficult to undergo a cautious and long titration. This medication is not recommended if symptoms are rapidly progressive and quick pain control is needed. However, based on clinical experience, lamotrigine can be a very effective adjunctive therapy or monotherapy for elderly patients who cannot tolerate the sedation and ataxia caused by carbamazepine and oxcarbazepine. Common side effects include dizziness, constipation, nausea, and drowsiness. Lamotrigine can cause serious rashes requiring hospitalization. The incidence of these rashes, which can include StevensJohnson syndrome is 0.3% (3 in 1,000) in adults who take it for epilepsy. About 7-10% of patients can develop benign skin rash during the first 1-2 months of treatment that often resolves with continued therapy (Wiffen & Rees, 2007). However, it is not possible to predict if a rash will further develop and become life threatening. Therefore, the medication should be discontinued at the first sign of rash that is drug related.

PART 3: NEXT LINE THERAPY Based on AAN Practice Parameters, there is insufficient evidence to support or refute the efficacy of any of the following therapies for controlling pain in patients with trigeminal neuralgia (Gronseth et al., 2008). However, these are therapies that can often serve as useful adjunctive therapies to help patients gain better pain control. Section one discusses the oral therapies available and section two highlights non-oral therapies that include IV medication, nasal spray, topical ointment, and injections.

Section 1: Oral Therapies Gabapentin Gabapentin is a GABA receptor agonist and inhibits release of excitatory neurotransmitters. This medication has many advantages, including faster titration, minimal drug interactions, and usually well-tolerated. Gabapentin has been proven to be effective for neuropathic pain (Serpell, 2002). In a retrospective review of ninety-two patients who took gabapentin for trigeminal neuralgia, forty-three patients reported reduction in facial pain occurring generally within one to three weeks, depending on the rate of dose titration (Chesire, 2002). The effective range of daily dosing was 100-2400mg, divided three times a day (mean dose was 930mg daily). The degree of benefit was complete in 16 patients, nearly complete in 9 patients, moderate in 12 patients, and partial in 6 patients. The medication was well tolerated and no serious side effects were reported. Gabapentin has also been found to be effective, with sustained relief, in multiple sclerosis patients with trigeminal neuralgia (Khan, 1998). From clinical experience, if a patient is already on combination therapy (such as carbamazepine and lamotrigine), but still does not have adequate pain control, then gabapentin can be considered as an additional therapy to layer on. Typical starting dose is 300mg daily for a week. Then it can be increased by 300mg daily each week. Doses are typically divided into three times a day. A typical maintenance dose is 900-2700mg daily. Gabapentin usually does not interact with other medications and has a favorable side effect profile. Potential side effects include dizziness, sleepiness, diarrhea, confusion, and nausea.

596

 Medical Management of Trigeminal Neuralgia

Pregabalin Pregabalin modulates voltage-gated calcium channels and reduces release of excitatory neurotransmitters and has analgesic, anxiolytic, and anticonvulsant properties. Specifically, it is an alpha2-delta (a subunit of voltage-gated calcium channels) binding drug, resembling gabapentin (Obermann et al., 2008). Pregabalin maintains the biological activity of gabapentin but provides improved pharmacokinetics. It is completely absorbed, not metabolized, not bound to plasma proteins, and eliminated unchanged through the kidneys (Obermann et al., 2008). One advantage of pregabalin is that its pharmacokinetic profile allows rapid dose escalation if needed. Placebo-controlled studies have shown that pregabalin has efficacy for pain relief in treatment of diabetic neuropathy and postherpetic neuralgia by improving affective symptoms, sleep, and quality of life (Obermann et al., 2008). In terms of evidence in treatment of trigeminal neuralgia, a prospective, open-label study, with 53 patients and one-year follow-up, showed that pregabalin 150-600mg daily was effective in reducing pain by over 50% in 74% of patients. There was minor reduction of efficacy over the one-year observational period (Obermann et al., 2008). In a multi-center, observational, prospective 12-week study with 64 patients, there was alleviation of pain in 25% of patients and at least 50% reduction of pain intensity in 49% of patients who took pregabalin 150-600mg daily (mean final dose of 196±105mg/day) (Perez, Navarro, Saldana, Martinez, & Rejas, 2009). Treatment with pregabalin also reduced pain-related comorbid symptoms (anxiety/depression symptoms and difficulty with sleep) and improved disability and quality of life (Perez, Saldana, Navarro, Martinez, & Rejas, 2009). This study suggests that pregabalin can be used in monotherapy or in combination therapy to effectively treat trigeminal neuralgia. And given that patients with trigeminal neuralgia may frequently develop anxiety, depression, and difficulty with sleep, pregabalin can potentially also treat these comorbid conditions in the short-term. Pregabalin is available in 25mg, 50mg, 75mg, 100mg, 200mg, 225mg, and 300mg capsules. Dosing can be twice daily which provides more convenience for the patient and could lead to higher compliance. However, based on clinical experience, most patients usually need three times a day dosing. Initial dosing starts with 50-75mg daily and can be titrated up by 50-75mg daily each week. A typical maintenance dose is 150mg two to three days daily. The most common side effects of pregabalin are dizziness, somnolence, peripheral edema, dry mouth, weight gain.

Duloxetine Duloxetine is a serotonin-noradrenaline reuptake inhibitor that has FDA approval for the management of major depressive disorders, fibromyalgia, and diabetic peripheral neuropathic pain (Lunn, Hughes, & Wiffen, 2014). The mechanism of duloxetine for trigeminal neuralgia is thought to be related to modulation of norepinephrine and serotonin and antagonist of NMDA (N-methyl-D-aspartate) receptors. There has been a proposal that duloxetine exerts desynchronizing effects through its NMDA antagonism and thereby modulating the hyperexcitable state of the trigeminal afferents (Bymaster, Lee, Knadler, Detke, & Lyengar, 2005). An open-label study form 2011 examined the efficacy of duloxetine monotherapy in trigeminal neuralgia and showed promising results (Anand, Khikav, Prasad, & Shewtengna, 2011). Fifteen patients with trigeminal neuralgia were administered duloxetine 40mg daily. Statistically significant pain relief was

597

 Medical Management of Trigeminal Neuralgia

reported in 9 out of 15 patients. The pain relief was reported as early as in one week and was maintained for 16 weeks. The drug was well tolerated and side effects were mild and reversible. Duloxetine may also be helpful in the setting of trigeminal neuralgia and depression. A case report from 2014, a patient who was refractory to carbamazepine and surgery was started on duloxetine 30mg daily for management of depression and was then titrated to 60mg daily (Hsu, Chang, Peng, & Liang, 2014). The patient reported remarkable relief of her pain within the first week. Her depressed mood gradually improved in the following 3 weeks. At the 4-year follow-up, her depression and trigeminal neuralgia were well managed on duloxetine 60mg daily and carbamazepine 600mg daily. Duloxetine is available in 20mg, 30mg, 40mg, and 60mg capsules. Starting dose is typically 20mg twice a day. Within one to two weeks, the dose is usually increased to 30mg twice a day. Maximum dose is 120mg daily. There is lack of evidence for higher dosing. Based on clinical experience, duloxetine is primarily used as an adjuvant in treatment-resistant trigeminal neuralgia. Common side effects include nausea, dry mouth, constipation, diarrhea, fatigue, drowsiness, loss of appetite, agitation, and dizziness. If a patient needs to discontinue duloxetine, then a slow taper is strongly recommended. With an abrupt discontinuation, patients can experience potentially unpleasant withdrawal symptoms such as nightmares, mood swings (irritability and anger), anxiety, insomnia, nausea and vomiting.

Topiramate Topiramate was first identified as an antiepileptic medication. It acts at different neural transmission levels such as sodium channels and can enhance GABA levels. It has a wide range of uses including treatment of migraine and depression. Topiramate can also be used for trigeminal neuralgia, however, its efficacy remains controversial. A meta-analysis of six randomized controlled trials, with poor methodological quality, that included 354 patients with trigeminal neuralgia, showed that topiramate was more effective than carbamazepine after a treatment duration of two months (Wang, Bai, 2011). However, there was no difference in effectiveness rate after one month of treatment, remission rate after two months of treatment, or in adverse events when comparing topiramate with carbamazepine. All initial dosing was 25mg twice a day and then gradually increased. Maximum dose range was 200-600mg daily. Duration of trials ranged from one to two months. In practice, topiramate is usually started at 25mg daily and then increased by 25mg daily each week. In the treatment of migraine, doses beyond 100mg daily do not show greater benefit but do cause more side effects. There is no data that supports a specific upper limit to dosing of topiramate for the treatment of trigeminal neuralgia. Some case series found that topiramate 100-400mg daily can be effective (Domingues, Kuster, & Aquino, 2007). Dose titration should be based on pain control and side effects that the patient experiences. Common side effects include, paresthesia, word-finding difficulty, confusion, fatigue, loss of appetite, weight loss. More serious adverse effects include development of kidney stones.

Phenytoin Phenytoin, similar to carbamazepine, blocks the sodium channels of excitatory membranes and therefore blocks action potentials. It depresses excitatory transmission at the synaptic level (Green & Selman, 1991). Braham and Saiz first recommended the use of phenytoin for the treatment of trigeminal neuralgia in 1960 (Braham & Saiz, 1960). The existing studies of phenytoin in the treatment of trigeminal neuralgia continue to be limited to those studies that were done in the1960’s which showed that 54-70% 598

 Medical Management of Trigeminal Neuralgia

of patients experienced partial or complete pain relief (Blom, 1962; Blom, 1963; Braham & Saiz, 1960). In terms of dosing, the existing studies used 300-600mg daily or 400-800mg daily. In clinical practice, oral phenytoin is rarely used for long-term treatment of trigeminal neuralgia because the evidence is poor and because of its side effect profile. Common side effects included nausea, vertigo, nystagmus tremor, and ataxia. More worrisome, long-term side effects include liver dysfunction, osteoporosis, and gingival hyperplasia. In “Non-oral Therapies” section, there will be further discussion regarding IV fosphenytoin for the treatment of trigeminal neuralgia.

Levetiracetam The exact mechanism of action of levetiracetam is unknown. Its pharmacokinetics are linear and predictable and reaches peak plasma concentration within 1.5 hours, which is very useful when a rapid response is needed. Unlike carbamazepine and other antiepileptic medications, it does not affect the hepatic cytochrome P450 system. In an open-label prospective study, ten patients with trigeminal neuralgia were started on levetiracetam 1,000mg twice a day and titrated up by 500mg daily (Jorns, Johnston, & Zakrzewska, 2009). Maximum dose range was 3,000-5,000mg daily, which is higher than the recommended dose for epilepsy patients (3,000mg daily). Such a high dose was targeted because patients failed to respond to lower doses. After ten weeks, four patients, on higher doses of 4,000mg/day, had less pain compared with baseline (50-90% improvement). But four other patients actually felt worse after treatment. The final results showed that levetiracetam, at high doses, was only partially effective for trigeminal neuralgia pain relief, but it was very well tolerated. Another study with twenty-three patients showed that there was a 62% reduction of daily attacks when levetiracetam was used as an add-on therapy (Mitsikostas et al. 2010). The advantages of levetiracetam is that it does not interact with other medications and it is usually well tolerated. Common side effects include irritability, aggressive behavior, and change in personality.

Other Oral Therapies There are other oral therapies that have been tried in the treatment of trigeminal neuralgia (Zhang, Yang, & Zhou 2013; Yang, Zhou, He, Chen, & Zakrzewska, 2011). However, the evidence is poor, or there are no dedicated studies to trigeminal neuralgia, such as sodium valproate and tricyclic antidepressants, respectively (Derry, Wiffen, Aldrington, & Moore, 2015; Peiris, Perera, Devendra, & Lionel, 1980). Pimozide, tizanidine, and clonazepam are certainly oral options to consider if a patient has refractory trigeminal neuralgia but they all have significant limitations. Pimozide is an anti-psychotic that blocks dopamine receptors. It is primarily used in the treatment of Tourette syndrome. In a randomized trial of 48 patients with trigeminal neuralgia, pimozide (2-12mg daily) was reported to be more effective than carbamazepine but more people experienced adverse effects with pimozide than with carbamazepine (Lechin et al., 1989). Adverse effects included hand tremors, memory impairment, and involuntary movements. Clinically, pimozide is rarely used for the treatment of trigeminal neuralgia because of potentially long-term, extrapyramidal symptoms such as akasthesia, tremor, and slow or shuffling gait. Tizanidine, an antispasmodic, is a centrally acting alpha-adrenergic agonist that may also have antinociceptive properties. It has proven efficacy in a double-blind crossover study in patients with refractory trigeminal neuralgia, in which eight out of ten patients had fewer painful paroxysms while taking tizanidine 2mg three times a day for 3 days and then 4mg three times a day for 4 days (Fromm, 599

 Medical Management of Trigeminal Neuralgia

Aumentado, & Terrence, 1993). All patients that were followed-up after 1-3 months experienced recurrence of pain. However, another study found that tizanidine (up to 18mg/day) vs. carbamazepine (up to 900mg/day) had no significant effect on the number of people with relief of pain after treatment for 3 weeks (Vilming, Lyberg, & Latase, 1986). Overall, tizanidine has mixed results and limited efficacy for treating trigeminal neuralgia. Common side effects are dizziness, drowsiness, fatigue, and dry mouth. Clonazepam is a benzodiazepine that facilitates and enhances GABA transmission in the brain. In a preliminary trial of 19 patients, 68.4% showed excellent or good improvement with no serious side effects (Chandra, 1976). In an open-label study, twenty-five patients with trigeminal neuralgia were treated with 1mg twice to three times a day, titrated up to 6-8mg total each day, over a period of ten days (Court & Kase, 1976). The medication was continued for six to nine weeks if it was effective after the initial tenday trial. Reported clinical effectiveness was 65%, with 40% of patients achieving complete pain control and 23.3% were much improve. However, side effects of somnolence, confusion, and unsteadiness of gait was present in greater than 80% of the patients. In patients older than 60 years old, the unsteadiness was so severe they had to stay in bed. In clinical practice, clonazepam is not a preferred treatment for daily and long-term use because of withdrawal symptoms and risk of developing dependency and addiction.

Section 2: Non-Oral Therapies IV Fosphenytoin Intravenous fosphenytoin is a rapid onset, short-term treatment in select patients with acute, severe episodes of rigeminal neuralgia crisis. Compared to phenytoin, fosphenytoin has the advantage of better tolerability and ease of administration with faster infusion rates and lower risk for hypotension and hemodynamic instability. In a case series of three patients presenting with trigeminal neuralgia crisis who were refractory to oral medications, intravenous fosphenytoin was urgently used for treatment (Cheshire, 2001). Fosphenytoin was diluted to 5-10mg phenytoin sodium equivalents (PE)/mL in 5% dextrose with 0.45% NaCl and injected through an intravenous catheter. Hemodynamic parameters were monitored by electrocardiogram and sphygomomanometer during the infusions. Mean dose of 14mg/kg. In all cases, complete relief of pain was achieved for two days. The reported side effects included mild tinnitus, transient paresthesias, hypotension, and dizziness and ataxia that resolved the following day. As the author of the study points out, this therapy can be considered for cases of acute and sustained exacerbations of chronic recurrent trigeminal neuralgia that is refractory to other medications or serve as a short-term option for patient awaiting surgical intervention. Achieving urgent control of pain can provide a window of time when other medication and therapeutic options can be optimized.

Topical Capsaicin Capsaicin is a secondary metabolite produced by chili peppers. By enhancing release and inhibiting reuptake of substance P, it selectively stimulates and then blocks nociceptive function of C-fiber afferents. Repeated application of capsaicin has been used to treat localized pain syndromes Data for the treatment of trigeminal neuralgia with capsaicin is mixed and poor. In an open-label study, twelve patients with trigeminal neuralgia applied 1g of cream, containing 0.05% capsaicin, to the cutaneous area corresponding to the affected distribution of the trigeminal branch (excluding the eyelid or periocular regions), three times a day for several days (Fusco & Allessandri, 600

 Medical Management of Trigeminal Neuralgia

1992). Treatment was stopped when the patient no longer experienced burning sensation with application of the capsaicin. Six patients had complete relief of pain, four patients had partial relief of pain, and two patients had no relief of pain. Of the ten patients who were responsive to capsaicin, four had relapses of pain in 95-149 days. There were no relapses following the second therapy for the rest of the year. In a case series of 24 patients with chronic oral pain (five had a diagnosis of trigeminal neuralgia), capsaicin cream (0.025%) was applied to the site of discomfort four times a day for four weeks (Epstein & Marcoe, 1994). There was complete remission of neuropathic pain in 31.6% of patients. Trigeminal neuralgia with intraoral trigger was less responsive, only one out of five trigeminal neuralgia patients reported improvement. Common side effects include burning at the time of application. Patients should not apply capsaicin on the eyelid or in the periocular regions. Contact with the conjunctiva or other ocular tissues can cause intense irritation or even permanent damage in these structures.

Intranasal Lidocaine Just posterior to the middle turbinate, the second division of the trigeminal nerve passes through the sphenopalatine ganglion. The anatomic location of the SPG allows access for administration of topical anesthetic. For transient analgesia of second-division trigeminal neuralgia, intranasal lidocaine can be used. Nose spray is a preferred method of administration because of ease of administration by the patient. In a randomized controlled study of twenty-five patients with second-division trigeminal neuralgia, patients received two sprays (0.2mL) of either lidocaine 8% or saline placebo in the affected nostril using a metered-dose spray (Kanai, Suzuki, Kobayashi, & Hoka, 2006). Intranasal lidocaine 8% spray resulted in a significant decrease of VAS score whereas placebo spray did not. Pain was described as moderate or better by twenty-three patients of the lidocaine spray group and by one patient of the placebo group. The effect of treatment lasted for an average of 4.3 hours (range was 0.5-24 hours). Over half of the patients reported stinging or burning sensation in the nasal mucosa, but there were no other reported serious adverse effects. In terms of limitations of this treatment, it is restricted to patients with pain in the second trigeminal division and the benefits are very short-lasting.

Sumatriptan In the setting of trigeminal neuralgia, sumatriptan (a serotonin 5-HT 1B/1D receptor agonist) can potentially inhibit neurogenic inflammation and vasodilation near the irritated trigeminal root. In a randomized controlled trial, 24 patients with classical TN, refractory to previous treatment, received either 3mg of subcutaneous sumatriptan or saline (Kanai, Saito, & Hoka, 2006). After seven days, patients crossed over to receive the alternative treatment. Fifteen minutes after injection of sumatriptan, the baseline pain score decreased significantly; whereas the pain score did not decrease for the placebo group. The number of patients who benefited from sumatriptan was 20 whereas only one patient reported improvement after placebo. The mean duration of pain relief was 7.9 hours. In a second trial by the same group, 15 patients were first treated with subcutaneous injection of sumatriptan 3mg and then with one-week oral administration of sumatriptan (50mg twice daily) (Kanai, Suzuki, Osawa, & Hoka, 2006). At the end of oral treatment, pain scores were significantly decreased and this beneficial reduction persisted for another week after treatment discontinuation. Adverse effects associated with oral sumatriptan were fatigue, nausea, chest discomfort. Patients with known coronary artery disease or uncontrolled hypertension should not use sumatriptan. In clinical prac601

 Medical Management of Trigeminal Neuralgia

tice, sumatriptan is rarely is used for the treatment of trigeminal neuralgia because there is concern for cardiovascular side effects from daily use of sumatriptan. But the above studies do seem to suggest that sumatriptan could be potentially be considered for use as a short-term preventive of trigeminal neuralgia.

Nerve Blocks A potential adjunctive treatment is the combination of an antiepileptic drug with an analgesic block for trigeminal neuralgia trigger points. Local anesthetics at low doses block anomalous membrane excitability and potentially lead to improved control of the instability of membrane potential. Nerve block of trigger points with ropivacaine has been used to improve the therapeutic effect of gabapentin in the treatment of trigeminal neuralgia. In a four-week long, randomized trial of thirty-six patients, once a week nerve block with ropivacaine together with oral gabapentin resulted in a greater reduction of pain scores than gabapentin alone or ropivacaine alone at seven and twenty-eight days after treatment, an effect that was still present six and twelve months later (Lemos, Flores, Oliveira, & Almeida, 2008). Also, the patients on combination therapy were able to stay on lower daily doses of gabapentin (mean dose of 300mg daily) than the patients on gabapentin alone (mean dose of 525mg daily). For the analgesic block, a 27-gauge needle was used for administering subcutaneously 2mL of a 2mg/mL ropivacaine solution in each trigger point that was pointed out by the patient. These points varied for each patient and could be located in the V1, V2, or V3 distribution. Some patients received injections in more than one distribution of the face. Nerve blocks are usually very safe and have minimal side effects.

Acupuncture The use of acupuncture for treatment of chronic pain is becoming more common and accepted in developed countries. In traditional Chinese medicine, pain is a sign of blockage of the flow of qi (energy, air, or essence). Physiological studies show that acupuncture stimulation can induce changes in the nervous system, particularly in pain inhibitory pathways (Zhao, Stillman, & Rozen, 2005). A review of twelve studies (n=920), with an acupuncture arm and carbamazepine as the control treatment, found four trials in which acupuncture was superior to carbamazepine, whereas the remaining eight trials showed no difference between the treatment and control groups (Zhao et al., 2005). All of the studies were low-quality, hence, meta-analysis was not performed. A systemic review from 2010 suggests that acupuncture is of similar efficacy as carbamazepine but with fewer adverse effects in treatment of trigeminal neuralgia; however, the evidence is weak because of low methodological quality of the reviewed studies (Liu, Li, Xu, Chung, & Zhang, 2010). Based on clinical experience, acupuncture can be a helpful adjunctive therapy, especially if patients also have other chronic pain syndromes, insomnia, or anxiety. If patients are open to this therapy and would like to try it as an adjunctive therapy, then the recommended frequency is one to two sessions each week for a total of eight to ten sessions. Side effects are usually minimal but can include syncope, bleeding and hematoma.

Botulinum Toxin A Botulinum toxin A (BTX-A) is a neurotoxin derived from Clostridium botulinum (Morra et al., 2016). BTX-A inhibits the release of acetylcholine at the neuromuscular junction, leading to muscle paralysis. 602

 Medical Management of Trigeminal Neuralgia

But in the treatment of chronic migraine, the implicated mechanism of BTX-A is inhibition of central and peripheral sensitization, which is a result of blocking of the TRPV1 receptor of unmyelinated C fiber terminals and inhibiting the release of peripheral pain molecules such as substance P, CGRP, and glutamate (Aoki, 2005). In the last fifteen years, there has been a number of studies on BTX-A for the treatment of trigeminal neuralgia (Guardinani, Sadoughi, Blitzer, & Sirois, 2013). A study from 2002 reported successful relief of twitching and pain in a patient with hemifacial spasm associated with trigeminal neuralgia (Micheli, Scorticati, & Raina, 2002). However, the treatment mechanism of BTX-A in trigeminal neuralgia remains unclear. Some studies suggest that BTX-A acts locally or on the trigeminal ganglia (Cui, Khanijou, Rubino, & Aoki, 2004; Xiao et al., 2013). Whereas other studies report a central antinociceptive effect of BTX-A in a rat model of trigeminal neuralgia (Matak, Bach-Rojecky, Fillipovic, & Lackovic, 2011). A 2016 study showed that peripherally applied BTX-A exerts antinociceptive function via reducing central sensitization and inhibiting high expression of nociceptors (Wu et al., 2016). In a 2016 systematic review and meta-analysis, four randomized controlled trials (n=178) were selected for analysis of safety and efficacy of botulinum toxin type A (BTX-A) for trigeminal neuralgia (Morra et al., 2016). According to the authors, “The evidence from this systematic review suggests that botulinum toxin type A has a clinically significant benefit in treatment of trigeminal neuralgia when compared to placebo in terms of proportion of responders, the mean paroxysms frequency per day, and the VAS score at the end of follow up. These overall outcomes consistently favored BTX-A compared with placebo across studies.” One of the studies was a randomized, double-blind, placebo-controlled trial (Wu et al, 2012). Though these results are promising, a careful comparison of the four studies reveals the wide variation of protocols for dosage, site of injections, number of injections, and frequency of injections. For instance, the dosage range amongst the studies was 25 to 100 units and some studies administered the injections subcutaneously, whereas others administered the injections intradermally. Two studies used trigger zones as injection sites (Shehata, El-Tamawy, Shalaby, & Ramzy, 2013; Wu et al, 2016). As for site selection, one study used dermatome and/or mucosa (Zhang et al., 2014). Another study used “various sites, 1cm apart from one another” (Zuniga, Piedimonte, Diaz, & Micheli, 2013). The two major reported adverse events were facial asymmetry and edema or hematoma at the site of injection. Both of these adverse effects were generally tolerated and transient. Edema and hematoma resolved within 5-6 days and facial asymmetry recovered within 5-7 weeks. Overall, the data supporting the use of BTX-A for treatment of trigeminal neuralgia is still limited. Existing studies suggest that BTX-A may be a safe and effective treatment for trigeminal neuralgia. Ongoing study is needed for the mechanism of action of BTX-A in trigeminal neuralgia. Larger randomized controlled trials are needed. And there needs to be a standard protocol for dosage, administration, and duration of treatment.

CONCLUSION In recent years, there has been an expanding selection of non-surgical treatment options for trigeminal neuralgia. However, carbamazepine remains the first-line treatment. Patients who cannot tolerate the side effects of carbamazepine are usually switched to oxcarbazepine, which is usually just as effective. Unfortunately, there is limited evidence for management of patients who fail first line therapy. As second-line treatment, lamotrigine and baclofen are often added on to first-line therapy for increased benefit and to minimize the dosage of carbamazepine or oxcarbazepine. But there are certainly cases 603

 Medical Management of Trigeminal Neuralgia

when lamotrigine and baclofen can be used as monotherapy. For patients who are refractory to both first and second-line treatments (and are not surgical candidates), it is necessary to try next-line therapies that include, not only oral medications, but also nasal spray, topical ointment, intravenous medication, and injections. Finding the optimal combination of therapies is heavily dependent on side effect profile and patient tolerance. Some of these next-line therapies can have potentially advantageous effects on comorbid conditions such as anxiety, depression, insomnia, muscle tension, and migraine.

REFERENCES Anand, K., Khikav, V., & Prasad, A., & Shewtengna. (2011). Efficacy, safety, and tolerability of duloxetine in idiopathic trigeminal neuralgia. Journal of the Indian Medical Association, 109(4), 264–266. PMID:22187799 Aoki, K. (2005). Review of a proposed mechanism for the antinocicpetive action of botulinum toxin type A. Neurtoxicology, 26(5), 785–793. doi:10.1016/j.neuro.2005.01.017 PMID:16002144 Beydoun, A. (2000). Safety and efficacy of oxcarbazepine: Results of randomized, double-blind trials. Pharmacotherapy, 20(8), 152–158. doi:10.1592/phco.20.12.152S.35254 PMID:10937814 Beydoun, A., Schmidt, D., & D’Souza, J. (2002). Oxcarbazepine versus carbamazepine in trigeminal neuralgia: a meta-analysis of three double blind comparative trials. Neurology, 58(suppl 3). Blom, S. (1962). Trigeminal neuralgia: Its treatment with a new anticonvulsant drug. Lancet, 1(7234), 839–840. doi:10.1016/S0140-6736(62)91847-0 PMID:13870089 Blom, S. (1963). Tic Douloureux Treated With New Anticonvulsant. Archives of Neurology, 9(3), 285–290. doi:10.1001/archneur.1963.00460090091009 PMID:14049402 Braham, J., & Saiz, A. (1960). Phenytoin in the treatment of trigeminal and other neuralgias. Lancet, 2(7156), 892–893. doi:10.1016/S0140-6736(60)91959-0 Bymaster, F. P., Lee, T. C., Knadler, M. P., Detke, M. K., & Lyengar, S. (2005). The dual transporter inhibitor duloxetine: A review of its preclinical pharmacology, pharmacokinetic profile, and clinical results in depression. Current Pharmocology Design, 11(12), 1475–1493. doi:10.2174/1381612053764805 PMID:15892657 Canavero, S., & Bonicalzi, V. (1997). Lamotrigine control of trigeminal neuralgia: An expanded study. Journal of Neurology, 244(8), 527–532. doi:10.1007004150050137 PMID:9309561 Chandra, B. (1976). The use of clonazepam in the treatment of trigeminal neuralgia. Proceedings of the Australian Association of Neurologists, 13, 119-22. Cheshire, W. Jr. (2001). Fosphenytoin: An intravenous option for the management of acute trigeminal neuralgia crisis. Journal of Pain and Symptom Management, 21(6), 506–510. doi:10.1016/S08853924(01)00269-X PMID:11397609 Cheshire, W. (2015). Cranial Neuralgias. Confinia Neurologica, 21(4), 1072–1085. PMID:26252592

604

 Medical Management of Trigeminal Neuralgia

Chesire, W. (2002). Defining the role for gabapentin in the treatment of trigeminal neuralgia: A retrospective study. The Journal of Pain, 3(2), 137–142. doi:10.1054/jpai.2002.122944 PMID:14622800 Court, J. E., & Kase, C. S. (1976). Treatment of tic douloureux with a new anticonvulsant (clonazepam). Journal of Neurology, Neurosurgery, and Psychiatry, 39(3), 297–299. doi:10.1136/jnnp.39.3.297 PMID:932745 Cruccu, G., & Truini, A. (2013). Refractory trigeminal neuralgia. Non-surgical treatment options. CNS Drugs, 27(2), 91–96. doi:10.100740263-012-0023-0 PMID:23225488 Cui, M., Khanijou, S., Rubino, J., & Aoki, K. R. (2004). Subcutaneous administration of botulinum toxin type A reduces formalin-induced pain. Pain, 107(1-2), 125–133. doi:10.1016/j.pain.2003.10.008 PMID:14715398 Derry, S., Wiffen, PJ., Aldrington, D., & Moore, R.A. (2015). Nortriptyline for neuropathic pain in adults. Cochrane Database Systematic Reviews, 8(1). Domingues, R., Kuster, G., & Aquino, C. (2007). Treatment of trigeminal neuralgia with low doses of topiramate. Arquivos de Neuro-Psiquiatria, 65(3b), 792–794. doi:10.1590/S0004-282X2007000500011 PMID:17952282 Epstein, J. B., & Marcoe, J. H. (1994). Topical application of capsaicin for treatment of oral neuropathic pain and trigeminal neuralgia. Oral Surgery, Oral Medicine, and Oral Pathology, 77(2), 135–140. doi:10.1016/0030-4220(94)90275-5 PMID:8139830 Ferrell, P., & McLeod, H. (2008). Carbamazepine, HLA-B*1502 and risk of Stevens-Johnson syndrome and toxic epidermal necrolysis: US FDA recommendations. Pharmacogenomics, 9(10), 1543–1546. doi:10.2217/14622416.9.10.1543 PMID:18855540 Fromm, G., Aumentado, D., & Terrence, C. (1993). A clinical and experimental investigation of the effects of tizanidine in trigeminal neuralgia. Pain, 53(3), 265–271. doi:10.1016/0304-3959(93)90222-B PMID:8351156 Fromm, G., & Terrence, C. (1987). Comparison of L-baclofen and racemic baclofen in trigeminal neuralgia. Neurology, 37(11), 1725–1728. doi:10.1212/WNL.37.11.1725 PMID:3313099 Fromm, G., Terrence, C., & Chattha, A. (1984). Baclofen in the treatment of trigeminal neuralgia: Double-blind study and longer-term follow-up. Annals of Neurology, 15(3), 240–244. doi:10.1002/ ana.410150306 PMID:6372646 Fusco, B., & Alessandri, M. (1992). Analgesic Effect of Capsaicin in idiopathic trigeminal neuralgia. Anesthesia and Analgesia, 74(3), 375–377. doi:10.1213/00000539-199203000-00011 PMID:1539818 Green, M., & Selman, J. (1991). Review Article: The Medical Management of Trigeminal Neuralgia. Headache, 31(9), 588–592. doi:10.1111/j.1526-4610.1991.hed3109588.x PMID:1774173 Gronseth, G., Crucu, G., Alksne, J., Argoff, C., Brainin, M., Burchiel, K., ... Zakrzewska, J. (2008). Practice Parameter: The diagnostic evaluation and treatment of trigeminal neuralgia (an evidence-based review). Neurology, 71(15), 1183–1190. doi:10.1212/01.wnl.0000326598.83183.04 PMID:18716236

605

 Medical Management of Trigeminal Neuralgia

Guardinani, E., Sadoughi, B., Blitzer, A., & Sirois, D. (2013). A new treatment paradigm for trigeminal neuralgia using botulinum toxin type A. The Laryngoscope, 124(2), 413–417. doi:10.1002/lary.24286 PMID:23818108 Hsu, C., Chang, C., Peng, C., & Liang, C. (2014). Rapid Management of trigeminal neuralgia and comorbid major depressive disorder with duloxetine. The Annals of Pharmacotherapy, 48(8), 1090–1092. doi:10.1177/1060028014532789 PMID:24788987 Jorns, T., Johnston, A., & Zakrzewska, J. (2009). Pilot study to evaluate the efficacy and tolerability of levetiracetam in treatment of patients with trigeminal neuralgia. European Journal of Neurology, 16(6), 740–744. doi:10.1111/j.1468-1331.2009.02585.x PMID:19475723 Jorns, T., & Zakrzewska, J. (2007). Evidence-based approach to the medical management of trigeminal neuralgia. British Journal of Neurosurgery, 21(3), 253–261. doi:10.1080/02688690701219175 PMID:17612914 Kanai, A., Saito, M., & Hoka, S. (2006). Subcutaneous sumatriptan for refractory trigeminal neuralgia. Headache, 46(4), 577–582. doi:10.1111/j.1526-4610.2006.00405.x PMID:16643550 Kanai, A., Suzuki, A., Kobayashi, M., & Hoka, S. (2006). Intranasal lidocaine 8% spray for seconddivision trigeminal neuralgia. British Journal of Anaesthesia, 97(4), 559–563. doi:10.1093/bja/ael180 PMID:16882684 Kanai, A., Suzuki, A., Osawa, S., & Hoka, S. (2006). Sumatriptan alleviates pain in patients with trigeminal neuralgia. The Clinical Journal of Pain, 22(8), 677–680. doi:10.1097/01.ajp.0000210917.18536.0d PMID:16988562 Ketter, T., Wang, P., Chandler, R., Alarcon, A., Becker, O., Nowakowska, C., ... Schumacher, M. (2005). Dermatology precautions and slower titration yield low incidence of lamotrigine treatment-emergent rash. The Journal of Clinical Psychiatry, 66(05), 642–645. doi:10.4088/JCP.v66n0516 PMID:15889953 Khan, O. (1998). Gabapentin relieves trigeminal neuralgia in multiple sclerosis patients. Neurology, 51(2), 611–614. doi:10.1212/WNL.51.2.611 PMID:9710050 Leandri, M., Lunardi, G., Inglese, M., Messmer-Uccelli, M., Mancardi, G. L., Gottlieb, A., & Solaro, C. (2000). Lamotrigine in trigeminal neuralgia secondary to multiple sclerosis. Journal of Neurology, 247(7), 556–558. doi:10.1007004150070157 PMID:10993501 Lechin, F., van der Dijs, B., Lechin, M., Amat, J., Lechin, A., Cabrera, A., ... Jimenez, V. (1989). Pimozide therapy for trigeminal neuralgia. Archives of Neurology, 46(9), 960–963. doi:10.1001/archneur.1989.00520450030015 PMID:2673161 Lemos, L., Flores, S., Oliveira, P., & Almeida, A. (2008). Gabapentin supplemented with ropivacaine block of trigger points improves pain control and quality of life in trigeminal neuralgia patients when compared with gabapentin alone. The Clinical Journal of Pain, 24(1), 64–75. doi:10.1097/AJP.0b013e318158011a PMID:18180639 Levy, R., & Proudfit, H. (1977). The analgesic action of baclofen (beta-(4-chlorophenyl)-gamma-aminobutyric acid). The Journal of Pharmacology and Experimental Therapeutics, 202, 437–445. PMID:886473

606

 Medical Management of Trigeminal Neuralgia

Liebel, J. T., Menger, N., & Langohr, H. (2001). Oxcarbazepine in der Behandlung der Trigeminusneuralgie. Nervenheilkunde: Zeitschrift für Interdisziplinaere Fortbildung, 20, 461–465. Liu, H., Li, H., Xu, M., Chung, K., & Zhang, S. (2010). A systematic review on acupuncture for trigeminal neuralgia. The Journal of Alternative Therapies, 16(6), 30–35. PMID:21280460 Lunardi, G., Leandri, M., Albano, C., Cultrera, S., Fracassi, M., Rubino, V., & Favale, E. (1997). Clinical effectiveness of lamotrigine and plasma levels in essential and symptomatic trigeminal neuralgia. Neurology, 48(6), 1714–1717. doi:10.1212/WNL.48.6.1714 PMID:9191794 Lunn, M., Hughes, R., & Wiffen, P. (2014). Duloxetine for treating pain neuropathy, chronic pain or fibromyalgia. Cochrane Database of Systematic Reviews, 3(1). PMID:24385423 Matak, I., Bach-Rojecky, L., Fillipovic, B., & Lackovic, Z. (2011). Behavioral and immunohistochemical evidence for central antinocicpetive activity of botulinum toxin A. Neuroscience, 186, 201–207. doi:10.1016/j.neuroscience.2011.04.026 PMID:21539899 Micheli, F., Scorticati, M. C., & Raina, G. (2002). Beneficial effects of botulinum toxin type a for patients with painful tic convulsive. Clinical Neuropharmacology, 25(5), 260–262. doi:10.1097/00002826200209000-00006 PMID:12410057 Mitsikostas, D. D., Pantes, G. V., Avramidis, T. G., Karageorgiou, K. E., Gartzonis, S. D., & Stathis, P. G. (2010). An observational trial to investigate the efficacy and tolerability of levetiracetam in trigeminal neuralgia. Headache, 50(8), 1371–1377. doi:10.1111/j.1526-4610.2010.01743.x PMID:21044281 Morra, M., Elgebaly, A., Elmaraezy, A., Khalil, A., Altibi, A., Vu, T., ... Hirayama, K. (2016). Therapeutic efficacy and safety of Botulinum Toxin A Therapy in Trigeminal Neuralgia: A systematic review and metaanalysis of randomized controlled trials. The Journal of Headache and Pain, 17(1), 63. doi:10.118610194-016-0651-8 PMID:27377706 Obermann, M. (2010). Treatment options in trigeminal neuralgia. Therapeutic Advances in Neurological Disorders, 3(2), 107–115. doi:10.1177/1756285609359317 PMID:21179603 Obermann, M., Yoon, M., Sensen, K., Maschke, M., Diener, H., & Katsarava, Z. (2008). Efficacy of pregabalin in the treatment of trigeminal neuralgia. Cephalalgia, 28, 174–181. PMID:18039340 Parekh, S., Shah, K., Kotdawalla, H., & Gandhi, I. (1989). Baclofen in carbamazepine resistant trigeminal neuralgia- a double blind clinical trial. Cephalalgia, 9(10_suppl), 392–393. doi:10.1177/0333102 489009S10208 Peiris, J. B., Perera, G. L. S., Devendra, S. V., & Lionel, N. D. W. (1980). Sodium valproate in trigeminal neuralgia. The Medical Journal of Australia, 2, 278. PMID:6776393 Perez, C., Navarro, A., Saldana, M. T., Martinez, S., & Rejas, J. (2009). Patient-reported outcomes in subjects with painful trigeminal neuralgia receiving pregabalin: Evidence from medical practice in primary care settings. Cephalalgia, 29(7), 781–790. doi:10.1111/j.1468-2982.2008.01792.x PMID:19522052 Perez, C., Saldana, M. T., Navarro, A., Martinez, S., & Rejas, J. (2009). Trigeminal neuralgia treated with pregabalin in family medicine settings: Its effect on pain alleviation and cost reduction. Journal of Clinical Pharmacology, 49(5), 582–590. doi:10.1177/0091270009333017 PMID:19299534

607

 Medical Management of Trigeminal Neuralgia

Saito, K., Konishi, S., & Otsuka, M. (1975). Antagonism between Lioresal and substance P in rat spinal cord. Brain Research, 97(1), 177–180. doi:10.1016/0006-8993(75)90928-2 PMID:1175037 Serpell, M. G. (2002). Neuropathic pain study group. Gabapentin in neuropathic pain syndromes: A randomized, double-blind, placebo-controlled trial. Pain, 99, 557–566. doi:10.1016/S0304-3959(02)00255-5 PMID:12406532 Shaikh, S., Yaacob, H. B., & Abd Rahman, R. B. (2011). Lamotrigine for trigeminal neuralgia: Efficacy and safety in comparison with carbamazepine. Journal of the Chinese Medical Association, 74(6), 243–249. doi:10.1016/j.jcma.2011.04.002 PMID:21621166 Shehata, H., El-Tamawy, M., Shalaby, N., & Ramzy, G. (2013). Botulinum toxin type A: Could it be an effective treatment option in intractable trigeminal neuralgia? The Journal of Headache and Pain, 14(1), 92. doi:10.1186/1129-2377-14-92 PMID:24251833 Silver, M., Blum, D., Grainger, J., Hammer, A., & Quessy, S. (2007). Double-blind, placebo-controlled trial of lamotrigine in combination with other medications for neuropathic pain. Journal of Pain and Symptom Management, 34(4), 446–454. doi:10.1016/j.jpainsymman.2006.12.015 PMID:17662571 Taylor, J., Brauer, S., & Espir, M. (1981). Long-term treatment of trigeminal neuralgia. Postgraduate Medical Journal, 57(663), 16–28. doi:10.1136/pgmj.57.663.16 PMID:7279817 Terrence, C., & Fromm, G. (1981). Complications of Baclofen Withdrawal. Journal of the American Medical Association, 38(9), 588–589. PMID:6791618 Tomson, T., & Ekbom, K. (1981). Trigeminal neuralgia: Time course of pain in relation to carbamazepine dosing. Cephalalgia, 1(2), 91–98. doi:10.1111/j.1468-2982.1981.tb00015.x PMID:7346177 Tremont-Lukats, I., Megeff, C., & Backonja, M. M. (2000). Anticonvulsants for neuropathic pain syndromes: Mechanisms of action and place in therapy. Drugs, 60(5), 1029–1052. doi:10.2165/00003495200060050-00005 PMID:11129121 Vilming, S., Lyberg, T., & Latase, X. (1986). Tizanidine in the management of trigeminal neuralgia. Cephalalgia, 6(3), 181–182. doi:10.1046/j.1468-2982.1986.0603181.x PMID:3533272 Wang, Q. P., & Bai, M. (2011). Topiramate versus carbamazepine for the treatment of classical trigeminal neuralgia: A meta-analysis. CNS Drugs, 25(10), 847–857. doi:10.2165/11595590-000000000-00000 PMID:21936587 Wiffen, P., & Rees, J. (2007). Lamotrigine for acute and chronic pain. Cochrane Database of Systematic Reviews, 2, CD006044. PMID:17443611 Wu, C., Lian, Y., Zheng, Y., Zhang, H., Chen, Y., Xie, N., & Wang, L. F. (2012). Botulinum toxin type A for the treatment of trigeminal neuralgia results from a randomized, double-blind, placebo-controlled trial. Cephalalgia, 32(6), 443–450. doi:10.1177/0333102412441721 PMID:22492424 Wu, C., Xie, N., Lian, Y., Xu, H., Chen, C., Zheng, Y., ... Zhang, H. (2016). Central antinociceptive activity of peripherally applied botulinum toxin type A in lab rat model of trigeminal neuralgia. SpringerPlus, 5(1), 431. doi:10.118640064-016-2071-2 PMID:27104119

608

 Medical Management of Trigeminal Neuralgia

Xiao, L., Cheng, J., Zuang, Y., Qu, W., Muir, J., Liang, H., & Zhang, D. (2013). Botulinum toxin type A reduces hyperalgesia and TRPV1 expression in rats with neuropathic pain. Pain Medicine, 14(2), 276–286. doi:10.1111/pme.12017 PMID:23301515 Yang, M., Zhou, M., He, L., Chen, N., & Zakrzewska, J. (2011). Non-antiepileptic drugs for trigeminal neuralgia. Cochrane Database of Systematic Reviews, 1, CD004029. PMID:21249658 Zakrzewska, J., & Patsalos, P. (1989). Oxcarbazepine: A new drug in the management of intractable trigeminal neuralgia. Journal of Neurology, Neurosurgery, and Psychiatry, 52(4), 472–476. doi:10.1136/ jnnp.52.4.472 PMID:2738589 Zakrzewska, J., & Patsalos, P. (2002). Long-term cohort study comparing medical (oxcarbazepine) and surgical management of intractable trigeminal neuralgia. Pain, 95(3), 259–266. doi:10.1016/S03043959(01)00406-7 PMID:11839425 Zakrzewska, J. M., Chaudhry, Z., Nurmikko, T. J., Patton, D. W., & Mullens, E. L. (1997). Lamotrigine in refractory trigeminal neuralgia: Results from a double-blind placebo controlled crossover trial. Pain, 73(2), 223–230. doi:10.1016/S0304-3959(97)00104-8 PMID:9415509 Zhang, H., Lian, Y., Ma, Y., Chen, Y., He, C., Xie, N., & Wu, C. (2014). Two doses of botulinum toxin type A for the treatment of trigeminal neuralgia: Observation of therapeutic effect from a randomized, double-blind, double-blind, placebo controlled trial. The Journal of Headache and Pain, 15(1), 65. doi:10.1186/1129-2377-15-65 PMID:25263254 Zhang, J., Yang, M., Zhou, M., He, L., Chen, N., & Zakrzewska, J. M. (2013). Non-antiepileptic drugs for trigeminal neuralgia. Cochrane Database of Systematic Reviews. doi:10.1002/14651858.CD004029. pub4 PMID:24297506 Zhao, C., Stillman, M., & Rozen, T. (2005). Traditional and evidence-based acupuncture in headache management: Theory, mechanism, and practice. Headache, 45(6), 716–730. doi:10.1111/j.15264610.2005.05139.x PMID:15953304 Zuniga, C., Piedimonte, F., Diaz, S., & Micheli, F. (2013). Acute Treatment of Trigeminal Neuralgia with Onabotulinum Toxin A. Clinical Neuropharmacology, 36(5), 146–150. doi:10.1097/ WNF.0b013e31829cb60e PMID:24045604

This research was previously published in Effective Techniques for Managing Trigeminal Neuralgia edited by Steven Chang and Allen Ho, pages 45-69, copyright year 2018 by Medical Information Science Reference (an imprint of IGI Global).

609

610

Chapter 30

V2 Rhizotomy Lucas W. Campos Summit Pain Alliance, USA Nicholas Telischak Stanford University, USA Huy M. Do Stanford University, USA Xiang Qian Stanford University, USA

ABSTRACT Trigeminal neuralgia is a facial pain syndrome characterized by excruciating, paroxysmal, electric shock-like pain attacks in the sensory distribution of the trigeminal nerve. Medical management remains the first line of treatment. When this fails, surgical management needs to be considered. Percutaneous interventional procedures such as glycerol rhizotomy, radiofrequency (RF) thermocoagulation, and balloon compression of the trigeminal ganglion and its branches are some of the most commonly used procedures as they avoid exposure to general anesthesia, provide successful short-term results, and are available to people with significant co-morbidities. Of these, RF is the most often used. The V2 and V3 branches of the trigeminal nerve are most commonly affected, and are thus the most frequent targets for RF interventions. These procedures may be performed using conventional fluoroscopic, ultrasound, or CT-guided imaging, including combined flat-panel CT and fluoroscopy. This chapter summarizes these common ablation techniques targeting the V2 branch of the trigeminal nerve.

INTRODUCTION Trigeminal neuralgia (TN) is a severe, neuropathic pain condition affecting the distribution of the trigeminal nerve. The pain is often characterized as electric and sharp as if the face is being stabbed. Pain is often accompanied by a unilateral grimace, which led to the synonym “tic douloureux.”(Burchiel & Slavin, 2000). Attacks are most common in the second and third trigeminal divisions, on the right side of the face (Harness & Chase, 1990) . The attacks usually recur with the same intensity and distribution. DOI: 10.4018/978-1-5225-7122-3.ch030

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 V2 Rhizotomy

A brief refractory period of relief typically follows that lasts seconds to hours. This pain can be triggered by stimulating a specific facial area (e.g by light touch or tooth brushing) or can occur spontaneously (Rasmussen, 1991) . The etiology of TN is not fully understood. Dysfunction of the myelin sheath has been the focus of much investigation (Dubner, Sharav, Gracely, & Price, 1987). Clinical examination, imaging studies, and laboratory tests are usually unremarkable in classic TN (Rasmussen, 1990a). When the signs and symptoms of TN are secondary to another disease process it is called ‘‘symptomatic TN’’. The basic pathophysiology of TN remains largely unknown.(Bowsher, 1997; Canavero, Bonicalzi, & Pagni, 1995; Rasmussen, 1990b). Many TN patients suffer pain attacks for months or years before the condition is appropriately diagnosed. Over time, these severe pain attacks have a devastating impact on patients’ lives (Rasmussen, 1991). Timely and accurate diagnosis of TN speeds treatment with medication and surgical interventions which can help to limit this negative impact (Tartaro, Stroffolini, & Lepore, 1979). Aretaeus of Cappadocia is credited with the first clinical description of TN. At the end of the first century, he discovered heterocrania, which he described as spasm causing “distortion of the countenance” (Cappadocia.), 1856; Mosberg, 1960). In 1677, the noted American physician and philosopher, John Locke, identified the major clinical features of TN in his work Countess of Northumberland (Mosberg, 1960). It was the first time a physician found that this pain was not caused by dental pathology. In 1773, John Fothergill, an English physician, clearly established the disorder as a discrete syndrome (Eboli, Stone, Aydin, & Slavin, 2009; Pearce, 2003). In 1912, Sir William Osler, one of the four founding professors of Johns Hopkins Hospital, gave the most complete medical description of trigeminal neuralgia for his colleagues, giving new understanding of the disease’s pathophysiology (Casey & Jannetta, 2010). Dr. Osler found that specific trigger zones anywhere within the trigeminal distribution, could initiate these severe attacks and tics in the face (Dubner et al., 1987). He found this to be the reason patients avoided touching, washing, and shaving their faces. He also identified intraoral trigger zones, which were stimulated by chewing. This was important because most other facial pains were treated with massage or by applying heat and cold (Türp & Gobetti, 1996). The overall incidence rate is estimated at approximately three to five cases per year per 100,000 persons. Patients are more likely to be female and older than 50-60 when the first attacks begin (Massager et al., 2007). The age and sex distribution are interesting as most other common chronic headache and facial pain disorders occur at an earlier age (Fraioli, Lisciani, & Fraioli, 2014; Maarbjerg, Di Stefano, Bendtsen, & Cruccu, 2017). The paroxysmal pain usually worsens over time. While there are familial examples, TN does not appear to be increased in any particular ethnic group, geographic region, or climate (Duff, Spinner, Lindor, Dodick, & Atkinson, 1999; Smyth, Greenough, & Stommel, 2003; Maarbjerg et al., 2017).

PATHOPHYSIOLOGY Compression of the trigeminal nerve root by benign tumors and vascular anomalies can produce symptoms, which are indistinguishable from classic TN. This implies that injury to the nerve root is an important factor in the evolution of the disease (Devor, Amir, & Rappaport, 2002). Early research showed that surgical decompression of the nerve root from vascular anomalies often effectively alleviated the symptoms (Barker, Jannetta, Bissonette, Larkins, & Jho, 1996; Haines, Jannetta, & Zorub, 1980). Damage to the sensory neurons of the trigeminal nerve ganglion causes cascade of changes in the brainstem and 611

 V2 Rhizotomy

likely contributes to the signs and symptoms of TN (Rasminsky, 1978). Following trauma, regenerating peripheral nerve fibers become more depolarized and physiologically excitable. Spontaneous action potentials can originate from multiple sites. In this state, a single action potential may evoke sustained neural depolarizations (Anderson, Vakoula, & Veinote, 2003). Surgical biopsy specimens from TN patients with vascular compression present on imaging demonstrated evidence of inflammation, demyelination, and close apposition of axons (Deseure & Hans, 2015). Based on these morphologic and physiologic changes, an ‘‘ignition hypothesis’’ was formed to explain the principal signs and symptoms in TN. In this model, trigeminal injury induces hyper-excitability of the primary sensory neurons such that any individual neuron depolarization would activate the entire trigeminal system on that laterality. This sudden synchronous discharge according to this hypothesis would be the cause of the sudden lightening jolt of pain during a TN pain attack.

CLINICAL DIAGNOSIS The diagnosis of trigeminal neuralgia is made from the clinical history alone. No medical imaging or blood marker is available to confirm the diagnosis. Although the hallmark clinical findings of TN have been known for centuries, White and Sweet made a significant contribution by articulating precise and succinct diagnostic criteria for TN (White & Sweet, 1969). Their criteria rapidly gained popular acceptance with clinicians and scientists, and the ‘‘Sweet criteria’’ are still commonly used worldwide. The criteria emphasize 5 major clinical findings: 1. 2. 3. 4. 5.

The pain is paroxysmal. The pain may be provoked by light touch to the face (trigger zones). The pain is confined to the trigeminal distribution. The pain is unilateral. The clinical sensory examination is normal.

The International Classification of Headache Disorders II establishes classical trigeminal neuralgia as a discrete clinical diagnosis under the general classification of ‘‘cranial neuralgias and central causes of facial pain’’ (Flor et al., 2016; Olesen & Steiner, 2004). Criteria for classical TN by this classification are: 1. Paroxysmal attacks of pain lasting from a fraction of a second to 2 minutes, affecting one or more divisions of the trigeminal nerve and fulfilling criteria B and C: 2. Pain has at least one of the following characteristics: a. Intense, sharp, superficial or stabbing. b. Precipitated from trigger areas or by trigger factors. 3. Attacks are stereotyped in the individual patient. 4. There is no clinically evident neurological deficit. 5. Not attributed to another disorder. A TN ‘‘trigger zone’’ is an area of facial skin or oral mucosa where low-intensity mechanical stimulation (light touch, air puff, hair-bending) can elicit an attack (Rasmussen, 1991) . TN trigger zones are

612

 V2 Rhizotomy

typically only a few millimeters in size and are found in the perioral region (Crue, Shelden, Pudenz, & Freshwater, 1956). Though trigger zones are not always present in TN, the presence of a trigger zone is pathognomonic. The clinical examination of any patient with TN symptoms should include a comprehensive head and neck examination. The large majority of TN patients will have a normal sensory examination. More detailed quantitative sensory testing may demonstrate mild tactile sensory deficits in some patients (Maarbjerg et al., 2017). A map of any trigger zones should be drawn in the patient’s chart as these areas may change over time. Multiple sclerosis (MS) is another common cause of symptomatic TN, possibly due to demyelination plaques in the trigeminal root (Nurmikko, 2009). MS should be considered in any person with TN symptoms, particularly in younger patients or patients with bilateral TN. TN symptoms can be the first opportunity for the patient to be diagnosed with MS. The neurologic history supporting an MS diagnosis include unexplained episodes of monocular blindness, diplopia, vertigo, ataxia, paraparesis, or lateralized weakness.

DIFFERENTIAL DIAGNOSIS Glossopharyngeal Neuralgia Glossopharyngeal neuralgia (GN) is an uncommon craniofacial pain syndrome characterized by severe, transient, stabbing, or burning pain in the ear, base of the tongue, or tonsillar fossa (Revuelta-Gutiérrez, Morales-Martínez, Mejías-Soto, Martínez-Anda, & Ortega-Porcayo, 2016). The pain can spread to other areas of the face, including the external auditory canal or superficial cervical tissue (Blumenfeld & Nikolskaya, 2013). The pain occurs in the distribution of the glossopharyngeal nerve, as well as the auricular and pharyngeal branches of the vagus nerve. This disease can be mistaken for trigeminal neuralgia if a mandibular nerve distribution exists. GN pain is frequently triggered by chewing, swallowing, talking, yawning, or coughing. The attacks are typically paroxysmal, lightning pains, but some patients have more constant aching, burning, or pressure sensations. GN may be associated with severe bradycardia, hypotension, or transient asystole (Burfield, Ahmad, & Adams, 2016). The diagnosis can be confirmed with pain relief from topical anesthesia or glossopharyngeal block at the jugular foramen (Burfield et al., 2016) or at the styloid process (Telischak et al., 2017). As with trigeminal neuralgia, MRI and evoked potential testing are strongly recommended to rule out secondary causes.

Herpetic and Post-Herpetic Neuralgia of the Trigeminal Nerve Herpetic involvement of the trigeminal nerve is more common in older patients and in immunosuppressed patients. These populations are at higher risk to develop post-herpetic neuralgia (PHN) (O’Neill, Nurmikko, & Sommer, 2017). PHN pain is steady and sustained. The pain often spontaneously regresses within 2 or 3 weeks, but may persist for several months (Maarbjerg et al., 2017). When the pain occurs in persons more than 70 years of age, it may last a year or more. PHN pain is unilateral and is described as both burning and gnawing. It may be accompanied by a paroxysmal sharp, radiating pain caused by light mechanical stimuli (Lovell, 2015). It may occur in any part of the distribution of the trigeminal nerve, 613

 V2 Rhizotomy

but the forehead is most common. PHN hyperalgesia and paresthesia usually begins after the erythema and typical herpetiform lesions erupt (Nair, Gharote, Singh, & Jain-Choudhary, 2014). Patients may have weakness of the masseter and pterygoid muscles on the ipsilateral side (Nair et al., 2014).

Atypical Facial Pain Atypical facial pain (AFP) or facial pain of unknown cause is characterized by continuous, poorly localized deep burning or aching pain. AFP pain may be unilateral or bilateral and may not follow the distribution of specific peripheral nerves. The pain is often in the nasolabial fold or side of the chin and may spread to the upper or lower jaw or a wider area of the face of neck (Zakrzewska, 2016). Sensory changes, such as allodynia, dysesthesia, and paresthesia are usually present (Türp & Gobetti, 1996) . AFP usually affects middle-aged women. Some patients have a history of trauma or a dental or surgical procedure before the onset of pain (Weiss, Ehrhardt, & Tolba, 2017). Unlike TN, AFP is usually continuous with no periods of remission. Additionally, there are no autonomic symptoms associated with AFP.

MEDICAL MANAGEMENT Burchiel separated the diagnosis of TN into type 1 and type 2. Type 1 (classic TN) is characterized by unilateral, lancinating, attacks (Eller, Raslan, & Burchiel, 2005). The neurologic examination is normal, and there is a temporary or prolonged response to Carbamazepine. Type 2 (atypical TN) is similar to type 1, but has more constant, aching facial pain between the bouts of paroxysmal pain (Burchiel & Slavin, 2000). Type 2 trigeminal neuralgia may have some facial sensory loss and poor response to medications. It is possible that type 2 trigeminal neuralgia represents an advanced stage of type 1. Both type 1 and type 2 cases are believed to be caused by arterial or venous compression of the trigeminal nerve in the area of transition from central to peripheral myelin (Obersteiner-Redlich zone) near the root entry zone of the nerve to the brainstem (Samadian, Bakhtevari, Nosari, Babadi, & Razaei, 2015). Initial management of TN is medical. Surgical therapy is considered if medical treatment fails or secondary causes are found during the initial workup of the patient (Larsen, Piepgras, Chyatte, & Rizzolo, 2011). A neurosurgical consultation early in the medical management allow the patient to become educated about treatment options and give them time to contemplate potential interventional treatments should medical therapy prove inadequate or ineffective (Salama et al., 2009). Medical treatment is based on the capacity of the medications to decrease nerve hyperexcitability, either peripherally or centrally. The clinical trials in TN treatment did not provide a full understanding of each medication’s impact on this disease (Zakrzewska & Patsalos, 2002). Generally, medical treatment begins with an antiepileptic medication with known antineuralgic properties. Initial doses are low and titrated up gradually until the patient’s pain is satisfactorily reduced or the maximum tolerated dose is reached. Carbamazepine, 100 to 200 mg two or three times daily, is the gold standard treatment and usually provides relief in more than 60-70% of patients. There are multiple medication options available, but a response to carbamazepine is almost diagnostic (Sidebottom & Maxwell, 1995). If the Carbamazepine is not tolerated, other medications such as Baclofen, Sodium Valproate, Gabapentin, Lamotrigine, Oxcarbazepine, Topiramate, Felbamate, Zonisamide, Vigabatrin, Pregabalin, or Clonazepam may be effective (William P. Cheshire Jr, 2007; W. P. Cheshire, 1995; Fromm, Terrence, & 614

 V2 Rhizotomy

Chattha, 1984; Solaro, Messmer Uccelli, Uccelli, Leandri, & Mancardi, 2000; Solaro, Uccelli, Brichetto, Gaspperini, & Mancardi, 2001; Zakrzewska, 2010). Formal studies of these alternative agents have not been performed (Cheshire Jr, 2007; Zakrzewska, 2010). Trigeminal nerve blocks with local anesthetic and steroid can be extremely effective in the management of the acute pain of trigeminal neuralgia while the patient waits for pharmacologic interventions to become effective (Ro & Chang, 2005). If the patient has been without an attack for several months, slow medication tapering should begin (Larsen et al., 2011). Patients with trigeminal neuralgia often taper the medication themselves, only to have the pain start again (Larsen et al., 2011). Often a combination of antiepileptic medications is needed to relieve pain completely. Surgical options may be considered after multiple medication failures, intolerable of side effects, or pain escalation.

PATIENT SELECTION AND EVALUATION Surgical treatment of trigeminal neuralgia usually starts percutaneously and is best indicated for Burchiel type 1 TN (Eller et al., 2005). TN is a progressive disease, and classic TN can transform to Burchiel type 2 TN, characterized by more constant pain and sensory impairment. Although some reports have suggested that trials of at least 2 anticonvulsants should be performed before surgical intervention, this no evidence or guideline regarding a minimum duration of medical therapy before moving to an interventional strategy (Gronseth et al., 2008). Many patients experience initial relief with medication, but later develop breakthrough pain. Some studies show that more than 50% of patients with TN eventually undergo invention or surgery (Dalessio, 1982). Several factors should be taken into consideration when making the choice of which surgical procedure to undertake. Operations such as microvascular decompression (MVD) directly address the underlying disorder. This procedure requires general anesthesia and a retrosigmoid craniotomy, which can have a prolonged recovery period and so has historically been reserved for the younger, healthy patients. The percutaneous interventions are directed at other areas along the course of the trigeminal pathway, such as the trigeminal tracts in the brainstem, the nerve root, the Gasserian Ganglion, or the peripheral trigeminal nerve distributions (V1 to V3) (Pollock, 2012). Percutaneous procedures directed at the Gasserian Ganglion or trigeminal nerve root include Gamma Knife Radiosurgery (GKRS) of the cisternal portion of the trigeminal nerve. Other percutaneous techniques include glycerol Gasserian rhizotomy, radiofrequency (RF) rhizotomy, and balloon compression of the Gasserian Ganglion (Wang, Bender, & Bettegowda, 2016). The percutaneous procedures produce chemical, thermal, radiation or physical disruption of trigeminal nerve transmission. Percutaneous procedures are indicated in elderly patients or those with multiple medical comorbidities such that MVD presents a greater risk. Age alone is not an absolute contraindication for craniotomy, MVD has been shown to be well tolerated in patients older than 75 years (Cheng, Lim, Chang, & Barbaro, 2014). RF is not appropriate for patients who cannot tolerate an awake procedure or are unable to cooperate with the necessary localization stimulation (Wang et al., 2016). There is a greater risk of the trigeminal depressor response and hypotension and bradycardia when percutaneous balloon compression (PBC) is used. Thus, PBC is contraindicated in patients with cardiovascular disease (Skirving & Dan, 2001). RF provides more precise lesioning than glycerol rhizotomy (GR) or PBC. Interestingly, many surgeons advocate the use of PBC for isolated first-division pain due to its supposed superior fiber-selective nature (Giovanni Broggi, 2013) . 615

 V2 Rhizotomy

Atypical facial pain (AFP) has been associated with poorer outcomes in terms of symptom recurrence across several percutaneous and medication treatment modalities (J. M. Zakrzewska, Jassim, & Bulman, 1999). Patients with MS also represent a unique subgroup, because they can suffer from a combination of inflammatory and mechanical demyelination (Cheng, Sanchez-Mejia, Limbo, Ward, & Barbaro, 2005; Pollock, 2012).

HISTORY OF PERCUTANEOUS TREATMENTS The first attempted percutaneous treatment of TN occurred in 1910, when Harris injected the trigeminal ganglion with alcohol (Harris, 1912). Two years after Harris described his approach, Rethi treated patients with electrocoagulation of the trigeminal nerve and ganglion. The procedure was associated with a high complication rates as a result of unintended injury to the trigeminal nerve and surrounding structures due to limitations in electrode design and temperature control (Wang et al., 2016). In 1914, Hartel described a method for accessing the foramen ovale which is the basis for percutaneous procedures still in use today (Skirving & Dan, 2001) (Wang et al., 2016) . In 1974, Sweet and Wepsic, described RF of the trigeminal rootlets (Sweet & Wepsic, 1974). Their method used short-acting anesthetics to allow for more precise lesion creation using more precise electrical stimulation and temperature monitoring. Over the next few decades, Nugent further refined the RF technique by using a fine cordotomy-type electrode. Tew and Taha introduced curved thermistor-tipped electrodes, which achieved high rates of pain relief with fewer complications (Nugent, 1997; Nugent & Berry, 1974) . Glycerol rhizotomy (GR) use dates back to the late 19th century, when physicians injected various agents such as chloroform and osmic acid, next to nerve trunks (Cole, Liu, & Apfelbaum, 2005). Although reports indicated that this method was effective in producing pain relief, the effect was transient and often accompanied by significant weakness, sensory loss, and dysesthesias (Cole et al., 2005). GR therapy was refined in 1981 by Hakanson when his team was exploring the use of stereotactic radiotherapy for TN treatment (Lunsford & Bennett, 1984). Glycerol is a trivalent alcohol naturally present in human tissue. Hakanson used the Glycerol as a vehicle to suspend tantalum dust. This solution was then injected into the trigeminal cistern (Dulhunty & Gage, 1973). Hakanson later found that injection of Glycerol alone caused pain relief (Håkanson, 1981). The exact mechanism of action of glycerol is incompletely understood. Studies have suggested its hypertonicity causes a rapid rate of change in intracellular osmolarity, resulting in axonal demyelination and fragmentation (Pal, Dinda, Roy, & Banerji, 1989). GR is widely used for patients with Burchiel type 1, type 2, or multiple sclerosis related trigeminal neuralgia (Kim J. Burchiel, 2003; Håkanson, 1981). Clinical investigations demonstrate that approximately 90% of patients have complete or immediate pain relief following glycerol injection, and 77% have good or excellent pain control after a 10-year follow-up (Jho & Lunsford, 1997). Facial sensory loss may occur following glycerol rhizotomy: 32% to 48% are mild, 13% are moderate, and 6% are dense (Blomstedt & Bergenheim, 2002). Percutaneous balloon compression (PBC) was discovered in the 1950s when investigator found that scar tissue compressing the trigeminal nerve root was another cause of TN (Taarnhøj, 1952). In 1952, Taarnhøj described his surgical methodology for decompressing the dorsal trigeminal root. Later, Shelden and Pudenz reported their surgical method for decompression of the second and third nerve divisions (Shelden, Pudenz, Freshwater, & Crue, 1955). In working to decompress the trigeminal ganglion, they found that the effectiveness of their technique derived from the resultant injury to the posterior trigemi616

 V2 Rhizotomy

nal root posterior to the ganglion (Shelden et al., 1955). It was not until 1983, when Mullan and Lichtor described compression of the trigeminal ganglion with a percutaneously inserted Fogarty balloon catheter, that PBC became a viable treatment option (Lichtor & Mullan, 1990). Studies in rabbits revealed that compression seems to preferentially affect the medium and large myelinated pain fibers, sparing small fibers, allowing for recovery of motor and sensory function, and preservation of the corneal reflex (Lobato, Rivas, Sarabia, & Lamas, 1990). Currently, PBC is mainly indicated for patients with Burchiel type 1 or 2 and multiple sclerosis related TN. Pain relief following PBC is usually immediate, but can be delayed by a week after the procedure (Peters & Nurmikko, 2002). Numbness in the V2 and V3 distribution occurs in approximately 80% of patients, but is typically mild and often improves with time (Lichtor & Mullan, 1990). Most patients have some degree of pterygoid weakness, which is also mild and resolves after weeks to months. In rare cases, the unilateral symptomatic jaw weakness is permanent (Skirving & Dan, 2001). The possibility of permanent jaw weakness makes this procedure contraindicated for patients with preexisting contralateral jaw weakness (Lichtor & Mullan, 1990). Theoretically, this complication can also be a problem when this procedure is performed bilaterally, as with MS patients. Pain relief is immediate in 92% to 100% of patients, and recurrence rates are reported as 19% to 32% over 5 to 20 years (Blomstedt & Bergenheim, 2002). Radiofrequency ablation treatment (RFA) is thought to selectively injure the unmyelinated or poorly myelinated nociceptive nerves, but spare the heavily myelinated fibers associated with touch, proprioception, and motor function. The procedure consists of low-current stimulation to determine the proper position of the electrode over the pathologic trigeminal nerve fibers. This is followed by the creation of a permanent lesion by rapidly vibrating the tissue, which generates enough heat to slowly destroy the selected nerve fibers (Nugent, 1997). Mild paresthesia in the distribution of the facial pain is the goal of RF treatment of trigeminal neuralgia. Significant dysesthesia or sensory loss has been reported in 6% to 28% of treated patients, with loss of the corneal reflex in 3% to 8%, depending on the technique employed (Taha & Tew, 1996). Trigeminal nerve motor weakness has been reported in up to 14% of patients, but is most often mild and transient (Kanpolat, Savas, Bekar, & Berk, 2001). Investigators have reported that 88% to 99% of patients obtain immediate pain relief following RF, with 20% to 27% recurrence rates over a 9- to 14-year follow-up (Taha & Tew, 1996). Patients with a more dense sensory loss from the RF lesion tend to have a lower rate of recurrence, but may develop worsening pain due to anesthesia dolorosa. One clinical report found that 81% of patients obtained excellent pain relief with a second RF treatment (Cheng et al., 2014).

CONVENTIONAL V2 RF RHIZOTOMY The assumed highly effective nature of RFA treatment is thought to be related to the differential in thermocoagulation of the trigeminal rootlets. Lower temperatures seem to selectively inhibit nociceptive action potentials and spare the nerves that transmit tactile sensation (Son, Kim, Kim, Yang, & Lee, 2011). However, histologic animal studies have indicated that the induced thermal injury affects all sizes of nerve fibers, regardless of their myelination status (Smith, McWhorter, & Challa, 1981). Thus, reducing the overall sensory input to the trigeminal root may be the ultimate mechanism. The classic approach to RF therapy of the maxillary or mandibular branches of the TN involves placement of the needle through foramen ovale. RF through the foramen ovale can be a difficult and time617

 V2 Rhizotomy

consuming procedure for both the physician and the patient due to the need for very precise placement of the needle (Wu, Meng, Xu, Liu, & Wang, 2004). Failure to position the needle properly can lead to treatment failure or serious complications such as nonspecific lesion, intracranial hemorrhage, and infection (Kanpolat et al., 2001). An alternative approach focuses passing through foramen rotundum where V2 nerve branch exits the cranium, and subsequently crosses the pterygopalatine fossa, and enters the orbit through the inferior orbital fissure (Xu, Zhang, Chen, Wu, & Zhou, 2006). Approaching through the foramen rotundum, rather than the foramen ovale, has the potential to simplify targeted treatment of the maxillary branch of the trigeminal nerve in TN patients. Recent improvements in RF techniques have increased the accuracy of the procedure through the use of intraoperative computed tomography (CT) neuronavigation and frameless stereotactic cannulation of the foramen ovale, with good success (Gusmão, Oliveira, Tazinaffo, & Honey, 2003; Lin et al., 2011). Some investigators reported no difference in surgical outcome or pain relief between CT-guidance with 3D reconstruction and fluoroscopy-guided groups (Yang, Lin, Lee, Weng, & Liao, 2010). However, CTguidance significantly decreased the median time for needle placement (14 vs 40 min) and intraoperative patient discomfort. Another group proposed a CT-guided technique through the foramen rotundum and found that, compared to an approach through foramen ovale, thermocoagulation through foramen rotundum showed similar results for pain relief immediately and at a 1-year follow-up (Huang et al., 2014). This approach resulted in shorter procedural time and lower incidence of adverse effects such as masseter weakness and loss of corneal reflex. The RF procedure requires patient cooperation to localize facial stimuli. Avoidance of electrode placement beyond 10 mm of the profile of the clivus, where the trochlear and abducens nerve lie is imperative (Gusmão et al., 2003). Once the needle is in place, the patient can be awakened, and sensory and motor responses tested. Detailed mapping to then occurs to guide lesion placement and minimize sensory and motor side effects (Huang et al., 2014). Lesions are typically made at a maximum 55-60c to 80-90C for 30 - 120 seconds (Xu et al., 2006). The patient can be discharged home on the same day if stable, or observed overnight. Traditional radiofrequency lesioning of the Gasserian ganglion is thought to destroy the pain fibers at temperatures > 65°C. Pulsed radiofrequency is a nondestructive treatment that delivers short bursts of radiofrequency current from the tip of the electrode at 42°C with long pauses between to allow heat to dissipate in the target tissue. Pulsed RF is thought to cause microscopic damage to axonal microfilaments and microtubules with greater changes occurring in C fibers than in Alpha fibers, minimizing the occurrence of sensory or motor deficit in the surrounding tissues . An electron microscopic analysis comparing the effects of pulsed radiofrequency versus continuous radiofrequency on rabbit dorsal root ganglion found that pulsed radiofrequency was substantially less destructive . However, a recent randomized controlled trial comparing conventional radiofrequency with pulsed radiofrequency found that pulsed radiofrequency was not effective in reducing pain in patients with trigeminal neuralgia .

FLUOROSCOPICALLY GUIDED V2 TREATMENT During the procedure, the patient is placed in the supine position with the cervical spine in the neutral position. The coronoid notch is identified by palpating the area just anterior and slightly inferior to the acoustic auditory meatus (Lin et al., 2011). The patient holds their mouth in a neutral position. After the skin is prepared with antiseptic solution and local anesthetic, a 22-gauge, 2-inch styletted needle is 618

 V2 Rhizotomy

inserted just below the zygomatic arch directly in the middle of the coronoid notch (Bennett & Giovannitti, 1998). The needle is advanced under the fluoroscopic guidance until the lateral pterygoid plate is encountered. Selective blockade of the maxillary nerve is achieved by redirection anteriorly and slightly superiorly until the needle slips past the anterior margin of the lateral pterygoid plate (Singh, Srivastava, & Dang, 2001). A paresthesia in the distribution of the maxillary nerve is usually elicited about 1 cm deeper than the point at which the lateral pterygoid plate was encountered. After negative aspiration, 3 to 5 mL of local anesthetic and steroid solution is injected in incremental doses. The patient is observed carefully for signs of local anesthetic toxicity. Ablation can then be completed with radiofrequency needles or cryoprobes (Burton M. Onofrio, 1975).

ULTRASOUND GUIDED APPROACH FOR V2 ABLATION Although x-ray based guidance is still considered the “gold standard” in diagnostics and interventional procedures for head and neck blocks, the use of ultrasonography allows the visualization of soft tissues and surrounding vasculature within the pterygopalatine fossa with real-time needle placement. Ultrasound guidance via the coronoid notch allows identification of the maxilla, lateral pterygoid plate, lateral pterygoid muscle, and the maxillary artery. The ultrasound-guided technique starts with coronoid notch identification. Once identified, a high-frequency, linear ultrasound probe is placed transversely over the coronoid notch (Nader, Kendall, et al., 2013; Nader, Bendok, Prine, & Kendall, 2015; Sola et al., 2012). The coronoid notch provides an acoustic window into the pterygopalatine fossa and allows easy identification of the maxillary nerve. The temporomandibular joint can be identified by locating the ballshaped mandibular condyle and the mandibular neck (Nader, Schittek, & Kendall, 2013). Under real-time ultrasound guidance, a 22-gauge, 2-inch needle is inserted just below the zygomatic arch directly through the coronoid notch using an out-of-plane approach. The needle is advanced until contact with the lateral pterygoid plate. The needle is redirected toward the pupil of the eye until it slips past the anterosuperior margin of the lateral pterygoid plate and into the pterygopalatine fissure. After negative aspiration, 4 to 5 mL of local anesthetic, with or without 40 to 80 mg of depo-steroid are injected incrementally (Nader et al., 2015). The patient will then be observed carefully for signs of local anesthetic toxicity. Proximity to the sphenopalatine ganglion may cause partial blockade of this structure. This is followed by either a continuous or pulsed RF protocol.

CT GUIDED V2 RF ABLATION The patient is positioned supine and the head is taped gently to prevent accidental head movement. A positioning grid is placed over the cheek of the painful side. Oblique coronal scanning is conducted with the scanning frame parallel to the plane connecting external acoustic pore to ipsilateral maxillary third molar bone. The resulting CT image frame simultaneously captures the foramen rotundum (FR) and its external and internal openings. The intrinsic ruler of the CT scanner is used to measure the distance from the needle entry point to the external opening of FR or foramen ovale (FO) as well as to determine the needle entry angle. The skin and subcutaneous tissues are anesthetized and a 10 cm 22 gauge radiofrequency needle is inserted and advanced along the predetermined path based on the angle and depth previously measured. Intermittent CT guidance is used until reaching the external opening of 619

 V2 Rhizotomy

the FR or FO. After confirming the absence of blood, cerebral spinal fluid, or paresthesia, a sensory test is performed by stimulating the probe at 100 Hz with pulse width at 500 μS and amplitude at 0.2–0.5 mA until paresthesia concordant to the patient’s usual pain is achieved. A motor test is also performed to make certain that the probe was not near any other adjacent nerves. 0.5 mL of 1% lidocaine is injected 2 minutes prior to ablation and either a continuous or pulsed RF protocol is activated. With this approach, when compared with the classic approach through the FO, it appears to be able to not only provide similar pain relief up to at 1 year follow-up visit, but also with fewer adverse effects, except for facial hematoma and facial numbness, which are no worse than the classic approach. CT guidance also lowers procedure duration time and is better tolerated by the patients.

SIDE EFFECTS AND COMPLICATIONS Because of the highly vascular nature of the pterygopalatine fossa, significant facial hematoma may occur after trigeminal nerve block via the coronoid approach (Singh et al., 2001). This vascularity means use of small, incremental doses of local anesthetic is needed to avoid local anesthetic toxicity. Post-procedure dysesthesia, including anesthesia dolorosa, may occur in a small number of patients who undergo any neurodestructive procedure (Blomstedt & Bergenheim, 2002). These post-procedure symptoms are thought to be due to incomplete destruction of the neural structures. Sloughing of skin in the area of anesthesia also may occur. In addition to disturbances of sensation, blockade or destruction of the branches of the trigeminal nerve may result in abnormal motor function, including weakness of the muscles of mastication and secondary facial asymmetry due to muscle weakness or loss of proprioception. (Kanpolat et al., 2001; Skirving & Dan, 2001) . The patient should be warned that all of these complications may occur. Trigeminal depressor response can also be inadvertently evoked intraoperatively causing bradycardia and possible asystole. Pre- or intra-operative atropine (0.4mg) can be given to prevent such a complication (Wu et al., 2004).

PATIENT OUTCOMES Pain relief with RF is generally high with most studies reporting greater than 95% or complete pain resolution (G. Broggi, Franzini, Lasio, Giorgi, & Servello, 1990; Tronnier, Rasche, Hamer, Kienle, & Kunze, 2001). Rates of pain control and the duration of pain relief consistently correlate with the degree of sensory loss. A prospective study of 154 patients, found that a high degree of sensory loss predicted a low rates of pain recurrence but the highest rate of dysesthesia (Taha & Tew, 1996). In contrast, patients with mild sensory loss had the highest pain recurrence rates and the lowest rates of dysesthesia (Kanpolat et al., 2001). Most cases of masseter weakness and diplopia resolve by 6 to 12 months (Giovanni Broggi, 2013). In a series of 1600 patients, rates of anesthesia dolorosa ranged from 0% to 12% (Kanpolat et al., 2001). Another study demonstrated rates of corneal anesthesia from 1% to 20.3% (Giovanni Broggi, 2013) Rates of masseter weakness with RF ranged from 3% to 29%. Few studies have examined predictors of outcomes after RF treatment. Recently, Kosugi found that outcomes were significantly better for patients with isolated V3 vs V2 or multidivisional pain (Kosugi et al., 2015). Taha used a curved, rather than straight, electrode and created more selective lesions which decreased rates of sensory complications (Tew & Taha, 1995). 620

 V2 Rhizotomy

FUTURE DIRECTIONS The majority of studies of percutaneous rhizotomy are retrospective, and highly variable in their patient populations, treatment technique, and reported outcomes. Studies include varying numbers of patients with atypical pain, MS, and bilateral TN. Most series also include varying percentages of patients who have had multiple ablative treatments. Although the general technique for each procedure is similar, each type of percutaneous rhizotomy has operator-dependent technical variations that limit comparisons: 1. GR: The method for cisternography varies as does the volume of glycerin injected 2. PBC: The level of pressure and duration compression 3. RF: Type of electrode, delivery of energy, and location of lesioning. A lack of standardization in pain relief outcomes and definition of complications also limits comparisons of techniques. An additional complicating factor is whether patients require medications postoperatively to achieve complete pain control. Efforts at standardization have been made, including the Barrow Neurological Institute Pain Scale, which grades outcomes on a scale from I to V. Finally, there is high variability in the duration of follow-up. Although Kaplan-Meier analyses are able to in part control of such variability, the variability in outcomes reporting for TN makes defining the exact time of pain recurrence difficult. All of these factors hamper the use of single-modality studies in comparisons of outcomes across treatment modalities. In addition to incorporating new technical advances, future studies must overcome this patient heterogeneity, procedural variation, and nonstandard outcomes, which limit interpretation and thus advancement of these approaches.

CONCLUSION Diagnosing TN may require in multiple consultations, and may be preceded by misguided treatments and unnecessary procedures. Once TN has been diagnosed, many therapeutic options become available. The initial treatment is medical management. With many newer pharmacological agents become available, possibilities exist for either monotherapy or polypharmacy. Surgical interventions are available for patients who are intolerant of medication therapy or whose pain is extreme and unremitting. Secondary causes must be explored in all patients because, if such causes are discovered, surgical interventions may supersede medical options. Each of the medications and each of the surgical procedures is associated with side effects and potential risks. These pitfalls must be weighed based on each individual’s medical conditions, lifestyle, age, personal preference, and past therapies. Further reviews of the literature are helping guide the clinical treatment with evidence-based recommendations. The patient must be well-informed about both medical and surgical options as soon as the diagnosis is made. As part of the initial evaluation, the patient should be required to consult with both surgical and medical practitioners. This approach allows for a planned therapeutic attack, with all parties seeking timely and effective pain relief for the patient. Many elements of percutaneous rhizotomy have remained true to the techniques described by their pioneers. All 3 percutaneous procedures (GN, RF, and PBC) rely on Hartel’s landmarks to gain access to the foramen ovale. Much effort has been devoted to improving visualization and navigation to the

621

 V2 Rhizotomy

foramen ovale (Peris-Celda, Graziano, Russo, Mericle, & Ulm, 2013). Although fluoroscopy has been the imaging modality of choice, newer studies have demonstrated the potential usefulness of computed tomography (CT), flat panel CT, ultrasonography and neuronavigation systems, especially for patients with anatomic variants (Aydoseli et al., 2015; Huo et al., 2014). With refinement of electrodes to allow for small lesions, complication rates for RF are still relatively high compared with PBC and GR. The size of the lesion not only depends on the size of the electrode tip and the electrode diameter, as well as the duration of thermocoagulation and the temperature achieved in the tissue (Karol & Karol, 2009). Pulsed RF has been used successfully to treat spinal pain and use in patients with TN has been promising. Erdine and colleagues used pulsed radiofrequency current to treat 5 patients. 60% experienced durable pain relief and no neurologic complications were observed (Erdine et al., 2007). Percutaneous rhizotomy, in all its forms, offers pain relief for TN that is immediate with varying durability and a generally favorable side effect profile. However, treatment selection remains an inexact science in the absence of high quality outcomes data.

REFERENCES Anderson, L. C., Vakoula, A., & Veinote, R. (2003). Inflammatory hypersensitivity in a rat model of trigeminal neuropathic pain. Archives of Oral Biology, 48(2), 161–169. doi:10.1016/S0003-9969(02)00203-0 PMID:12642236 Aydoseli, A., Akcakaya, M. O., Aras, Y., Sabanci, P. A., Unal, T. C., Sencer, A., ... Izgi, N. (2015). Neuronavigation-assisted percutaneous balloon compression for the treatment of trigeminal neuralgia: The technique and short-term clinical results. British Journal of Neurosurgery, 29(4), 552–558. doi:10 .3109/02688697.2015.1019418 PMID:25807330 Barker, F. G. II, Jannetta, P. J., Bissonette, D. J., Larkins, M. V., & Jho, H. D. (1996). The long-term outcome of microvascular decompression for trigeminal neuralgia. The New England Journal of Medicine, 334(17), 1077–1083. doi:10.1056/NEJM199604253341701 PMID:8598865 Bennett, C. R., & Giovannitti, J. A. Jr. (1998). Neural blockade of oral and circumoral structures. In Neural Blockade in Clinical Anesthesia and Management of Pain (3rd ed.; p. 528). Philadelphia: Lippincott Williams & Wilkins. Blomstedt, P. C., & Bergenheim, A. T. (2002). Technical difficulties and perioperative complications of retrogasserian glycerol rhizotomy for trigeminal neuralgia. Stereotactic and Functional Neurosurgery, 79(3-4), 168–181. doi:10.1159/000070830 PMID:12890975 Blumenfeld, A., & Nikolskaya, G. (2013). Glossopharyngeal neuralgia. Current Pain and Headache Reports, 17(7), 343. doi:10.100711916-013-0343-x PMID:23709235 Bogduk, N. (2006). Pulsed radiofrequency. Pain Medicine, 7(5), 396–407. doi:10.1111/j.15264637.2006.00210.x PMID:17014598 Bowsher, D. (1997). Trigeminal neuralgia: An anatomically oriented review. Clinical Anatomy (New York, N.Y.), 10(6), 409–415. doi:10.1002/(SICI)1098-2353(1997)10:63.0.CO;2-J PMID:9358972

622

 V2 Rhizotomy

Broggi, G. (2013). Percutaneous retrogasserian balloon compression for trigeminal neuralgia. World Neurosurgery, 79(2), 269–270. doi:10.1016/j.wneu.2012.05.015 PMID:22634455 Broggi, G., Franzini, A., Lasio, G., Giorgi, C., & Servello, D. (1990). Long-term results of percutaneous retrogasserian thermorhizotomy for “essential” trigeminal neuralgia: Considerations in 1000 consecutive patients. Neurosurgery, 26(5), 783–786, discussion 786–787. doi:10.1227/00006123-199005000-00008 PMID:2352596 Burchiel, K. J. (2003). A new classification for facial pain. Neurosurgery, 53(5), 1164–1166, discussion 1166–1167. doi:10.1227/01.NEU.0000088806.11659.D8 PMID:14580284 Burchiel, K. J., & Slavin, K. V. (2000). On the natural history of trigeminal neuralgia. Neurosurgery, 46(1), 152–154, discussion 154–155. doi:10.1093/neurosurgery/46.1.152 PMID:10626945 Burfield, L., Ahmad, F., & Adams, J. (2016). Glossopharyngeal neuralgia associated with cardiac syncope. BMJ Case Reports, 2016. doi:10.1136/bcr-2015-214104 PMID:27102416 Canavero, S., Bonicalzi, V., & Pagni, C. A. (1995). The riddle of trigeminal neuralgia. Pain, 60(2), 229–231. doi:10.1016/0304-3959(94)00196-L PMID:7784109 Cappadocia, A. (1856). The extant works of Aretaeus: the Cappadocian. Sydenham Society. Casey, K. F., & Jannetta, P. J. (2010). History of Trigeminal Neuralgia. Trigeminal Neuralgia, 3. Oxford University Press. Cheng, J. S., Lim, D. A., Chang, E. F., & Barbaro, N. M. (2014). A review of percutaneous treatments for trigeminal neuralgia. Neurosurgery, 10(Suppl 1), 25–33, discussion 33. PMID:24509496 Cheng, J. S., Sanchez-Mejia, R. O., Limbo, M., Ward, M. M., & Barbaro, N. M. (2005). Management of medically refractory trigeminal neuralgia in patients with multiple sclerosis. Neurosurgical Focus, 18(5), e13. doi:10.3171/foc.2005.18.5.14 PMID:16419978 Cheshire, W. P. (1995). Felbamate relieved trigeminal neuralgia. The Clinical Journal of Pain, 11(2), 139–142. doi:10.1097/00002508-199506000-00009 PMID:7549170 Cheshire, W. P. Jr. (2007). Trigeminal neuralgia. Current Pain and Headache Reports, 11(1), 69–74. doi:10.100711916-007-0025-7 PMID:17214925 Cole, C. D., Liu, J. K., & Apfelbaum, R. I. (2005). Historical perspectives on the diagnosis and treatment of trigeminal neuralgia. Neurosurgical Focus, 18(5), E4. doi:10.3171/foc.2005.18.5.5 PMID:15913280 Crue, B. L., Shelden, C. H., Pudenz, R. H., & Freshwater, D. B. (1956). Observations on the pain and trigger mechanism in trigeminal neuralgia. Neurology, 6(3), 196–207. doi:10.1212/WNL.6.3.196 PMID:13297120 Dalessio, D. J. (1982). Trigeminal neuralgia. A practical approach to treatment. Drugs, 24(3), 248–255. doi:10.2165/00003495-198224030-00005 PMID:7128480

623

 V2 Rhizotomy

Deseure, K., & Hans, G. H. (2015). Chronic Constriction Injury of the Rat’s Infraorbital Nerve (IoN-CCI) to Study Trigeminal Neuropathic Pain. Journal of Visualized Experiments, (103). doi:10.3791/53167 PMID:26437303 Devor, M., Amir, R., & Rappaport, Z. H. (2002). Pathophysiology of trigeminal neuralgia: The ignition hypothesis. The Clinical Journal of Pain, 18(1), 4–13. doi:10.1097/00002508-200201000-00002 PMID:11803297 Dubner, R., Sharav, Y., Gracely, R. H., & Price, D. D. (1987). Idiopathic trigeminal neuralgia: Sensory features and pain mechanisms. Pain, 31(1), 23–33. doi:10.1016/0304-3959(87)90003-0 PMID:3696741 Duff, J. M., Spinner, R. J., Lindor, N. M., Dodick, D. W., & Atkinson, J. L. (1999). Familial trigeminal neuralgia and contralateral hemifacial spasm. Neurology, 53(1), 216–218. doi:10.1212/WNL.53.1.216 PMID:10408564 Dulhunty, A. F., Gage, P. W., & Barry, P. H. (1973). Differential effects of glycerol treatment on membrane capacity and excitation-contraction coupling in toad sartorius fibres. The Journal of Physiology, 234(2), 373–408. doi:10.1113/jphysiol.1973.sp010350 PMID:4203309 Eboli, P., Stone, J. L., Aydin, S., & Slavin, K. V. (2009). Historical characterization of trigeminal neuralgia. Neurosurgery, 64(6), 1183–1186. doi:10.1227/01.NEU.0000339412.44397.76 PMID:19487899 Eller, J. L., Raslan, A. M., & Burchiel, K. J. (2005). Trigeminal neuralgia: Definition and classification. Neurosurgical Focus, 18(5), E3. doi:10.3171/foc.2005.18.5.4 PMID:15913279 Erdine, S., Bilir, A., Cosman, E. R., & Cosman, E. R., Jr. (2009). Ultrastructural changes in axons following exposure to pulsed radiofrequency fields. Pain Practice: The Official Journal of World Institute of Pain, 9(6), 407–417. Erdine, S., Ozyalcin, N. S., Cimen, A., Celik, M., Talu, G. K., & Disci, R. (2007). Comparison of pulsed radiofrequency with conventional radiofrequency in the treatment of idiopathic trigeminal neuralgia. European Journal of Pain (London, England), 11(3), 309–313. doi:10.1016/j.ejpain.2006.04.001 PMID:16762570 Erdine, S., Yucel, A., Cimen, A., Aydin, S., Sav, A., & Bilir, A. (2005). Effects of pulsed versus conventional radiofrequency current on rabbit dorsal root ganglion morphology. European Journal of Pain (London, England), 9(3), 251–256. doi:10.1016/j.ejpain.2004.07.002 PMID:15862474 Flor, H., Rasche, D., Islamian, A. P., Rolko, C., Yilmaz, P., Ruppolt, M., & ... . (2016). Subtle Sensory Abnormalities Detected by Quantitative Sensory Testing in Patients with Trigeminal Neuralgia. Pain Physician, 19(7), 507–518. PMID:27676667 Fraioli, M. F., Lisciani, D., & Fraioli, C. (2014). Trigeminal neuralgia. Journal of Neurosurgery, 120(1), 288–289. doi:10.3171/2012.12.JNS101876 PMID:24180575 Fromm, G. H., Terrence, C. F., & Chattha, A. S. (1984). Baclofen in the treatment of trigeminal neuralgia: Double-blind study and long-term follow-up. Annals of Neurology, 15(3), 240–244. doi:10.1002/ ana.410150306 PMID:6372646

624

 V2 Rhizotomy

Gronseth, G., Cruccu, G., Alksne, J., Argoff, C., Brainin, M., Burchiel, K., ... Zakrzewska, J. M. (2008). Practice parameter: the diagnostic evaluation and treatment of trigeminal neuralgia (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology and the European Federation of Neurological Societies. Neurology, 71(15), 1183–1190. doi:10.1212/01. wnl.0000326598.83183.04 PMID:18716236 Gusmão, S., Oliveira, M., Tazinaffo, U., & Honey, C. R. (2003). Percutaneous trigeminal nerve radiofrequency rhizotomy guided by computerized tomography fluoroscopy. Technical note. Journal of Neurosurgery, 99(4), 785–786. doi:10.3171/jns.2003.99.4.0785 PMID:14567619 Haines, S. J., Jannetta, P. J., & Zorub, D. S. (1980). Microvascular relations of the trigeminal nerve. An anatomical study with clinical correlation. Journal of Neurosurgery, 52(3), 381–386. doi:10.3171/ jns.1980.52.3.0381 PMID:7359193 Håkanson, S. (1981). Trigeminal neuralgia treated by the injection of glycerol into the trigeminal cistern. Neurosurgery, 9(6), 638–646. doi:10.1227/00006123-198112000-00005 PMID:7322329 Harness, D. M., & Chase, P. F. (1990). Lateralization of chronic facial pain: Fact or fiction. Cranio, 8(4), 339–341. doi:10.1080/08869634.1990.11678335 PMID:2098197 Harris, W. (1912). Alcohol injection of the Gasserian ganglion for trigeminal neuralgia. Lancet, 179(4613), 218–221. doi:10.1016/S0140-6736(01)65362-5 PMID:19975621 Huang, B., Yao, M., Feng, Z., Guo, J., Zereshki, A., Leong, M., & Qian, X. (2014). CT-guided percutaneous infrazygomatic radiofrequency neurolysis through foramen rotundum to treat V2 trigeminal neuralgia. Pain Medicine, 15(8), 1418–1428. doi:10.1111/pme.12440 PMID:24716880 Huo, X., Sun, X., Zhang, Z., Guo, W., Guan, N., & Luo, J. (2014). Dyna-CT-assisted percutaneous microballoon compression for trigeminal neuralgia. Journal of Neurointerventional Surgery, 6(7), 521–526. doi:10.1136/neurintsurg-2013-010676 PMID:23904451 Jho, H. D., & Lunsford, L. D. (1997). Percutaneous retrogasserian glycerol rhizotomy. Current technique and results. Neurosurgery Clinics of North America, 8(1), 63–74. PMID:9018706 Kanpolat, Y., Savas, A., Bekar, A., & Berk, C. (2001). Percutaneous controlled radiofrequency trigeminal rhizotomy for the treatment of idiopathic trigeminal neuralgia: 25-year experience with 1,600 patients. Neurosurgery, 48(3), 524–532, discussion 532–534. doi:10.1097/00006123-200103000-00013 PMID:11270542 Karol, E. A., & Karol, M. N. (2009). A multiarray electrode mapping method for percutaneous thermocoagulation as treatment of trigeminal neuralgia. Technical note on a series of 178 consecutive procedures. Surgical Neurology, 71(1), 11–17, discussion 17–18. doi:10.1016/j.surneu.2007.09.021 PMID:18328544 Kosugi, S., Shiotani, M., Otsuka, Y., Suzuki, T., Katori, N., Hashiguchi, S., & Morisaki, H. (2015). Long-term outcomes of percutaneous radiofrequency thermocoagulation of gasserian ganglion for 2nd- and multiple-division trigeminal neuralgia. Pain Practice: The Official Journal of World Institute of Pain, 15(3), 223–228.

625

 V2 Rhizotomy

Larsen, A., Piepgras, D., Chyatte, D., & Rizzolo, D. (2011). Trigeminal neuralgia: Diagnosis and medical and surgical management. JAAPA: Official Journal of the American Academy of Physician Assistants, 24(7), 20–25. doi:10.1097/01720610-201107000-00005 PMID:21748954 Lichtor, T., & Mullan, J. F. (1990). A 10-year follow-up review of percutaneous microcompression of the trigeminal ganglion. Journal of Neurosurgery, 72(1), 49–54. doi:10.3171/jns.1990.72.1.0049 PMID:2294184 Lin, M. H.-C., Lee, M.-H., Wang, T.-C., Cheng, Y.-K., Su, C.-H., Chang, C.-M., & Yang, J.-T. (2011). Foramen ovale cannulation guided by intra-operative computed tomography with integrated neuronavigation for the treatment of trigeminal neuralgia. Acta Neurochirurgica, 153(8), 1593–1599. doi:10.100700701011-1009-2 PMID:21503836 Lobato, R. D., Rivas, J. J., Sarabia, R., & Lamas, E. (1990). Percutaneous microcompression of the gasserian ganglion for trigeminal neuralgia. Journal of Neurosurgery, 72(4), 546–553. doi:10.3171/ jns.1990.72.4.0546 PMID:2319312 Lovell, B. (2015). Trigeminal herpes zoster: Early recognition and treatment are crucial. BMJ Case Reports, 2015(mar20 1), bcr2014208673. doi:10.1136/bcr-2014-208673 PMID:25795749 Lunsford, L. D., & Bennett, M. H. (1984). Percutaneous retrogasserian glycerol rhizotomy for tic douloureux: Part 1. Technique and results in 112 patients. Neurosurgery, 14(4), 424–430. doi:10.1227/00006123198404000-00006 PMID:6728144 Maarbjerg, S., Di Stefano, G., Bendtsen, L., & Cruccu, G. (2017). Trigeminal neuralgia - diagnosis and treatment. Cephalalgia: An International Journal of Headache. Massager, N., Murata, N., Tamura, M., Devriendt, D., Levivier, M., & Régis, J. (2007). Influence of nerve radiation dose in the incidence of trigeminal dysfunction after trigeminal neuralgia radiosurgery. Neurosurgery, 60(4), 681–687, discussion 687–688. doi:10.1227/01.NEU.0000255393.77538.75 PMID:17415205 Mosberg, W. H., Jr. (1960). Trigeminal Neuralgia: Its History and Treatment. The Journal of Nervous and Mental Disease. Retrieved from http://journals.lww.com/jonmd/Citation/1960/07000/Trigeminal_Neuralgia__Its_History_and_Treatment.14.aspx Nader, A., Bendok, B. R., Prine, J. J., & Kendall, M. C. (2015). Ultrasound-Guided Pulsed Radiofrequency Application via the Pterygopalatine Fossa: A Practical Approach to Treat Refractory Trigeminal Neuralgia. Pain Physician, 18(3), E411–E415. PMID:26000688 Nader, A., Kendall, M. C., De Oliveria, G. S., Chen, J. Q., Vanderby, B., Rosenow, J. M., & Bendok, B. R. (2013). Ultrasound-guided trigeminal nerve block via the pterygopalatine fossa: An effective treatment for trigeminal neuralgia and atypical facial pain. Pain Physician, 16(5), E537–E545. PMID:24077204 Nader, A., Schittek, H., & Kendall, M. C. (2013). Lateral pterygoid muscle and maxillary artery are key anatomical landmarks for ultrasound-guided trigeminal nerve block. Anesthesiology, 118(4), 957. doi:10.1097/ALN.0b013e31826d3dfc PMID:23059449

626

 V2 Rhizotomy

Nair, P., Gharote, H., Singh, P., & Jain-Choudhary, P. (2014). Herpes zoster on the face in the elderly. BMJ Case Reports, 2014(1). doi:10.1136/bcr-2013-200101 PMID:25331144 Nugent, G. R. (1997). Radiofrequency treatment of trigeminal neuralgia using a cordotomy-type electrode. A method. Neurosurgery Clinics of North America, 8(1), 41–52. PMID:9018704 Nugent, G. R., & Berry, B. (1974). Trigeminal neuralgia treated by differential percutaneous radiofrequency coagulation of the Gasserian ganglion. Journal of Neurosurgery, 40(4), 517–523. doi:10.3171/ jns.1974.40.4.0517 PMID:4592266 Nurmikko, T. J. (2009). Pathophysiology of MS-related trigeminal neuralgia. Pain, 143(3), 165–166. doi:10.1016/j.pain.2009.03.019 PMID:19375226 O’Neill, F., Nurmikko, T., & Sommer, C. (2017). Other facial neuralgias. Cephalalgia: An International Journal of Headache. Olesen, J., & Steiner, T. J. (2004). The International classification of headache disorders, 2nd edn (ICDHII). Journal of Neurology, Neurosurgery, and Psychiatry, 75(6), 808–811. Retrieved from jnnp.bmj.com Onofrio, B. M. (1975). Radiofrequency percutaneous Gasserian ganglion lesions. Journal of Neurosurgery, 42(2), 132–139. doi:10.3171/jns.1975.42.2.0132 PMID:1113146 Pal, H. K., Dinda, A. K., Roy, S., & Banerji, A. K. (1989). Acute effect of anhydrous glycerol on peripheral nerve: An experimental study. British Journal of Neurosurgery, 3(4), 463–469. doi:10.3109/02688698909002832 PMID:2803594 Pearce, J. M. S. (2003). Trigeminal neuralgia (Fothergill’s disease) in the 17th and 18th centuries. Journal of Neurology, Neurosurgery, and Psychiatry, 74(12), 1688. doi:10.1136/jnnp.74.12.1688 PMID:14638891 Peris-Celda, M., Graziano, F., Russo, V., Mericle, R. A., & Ulm, A. J. (2013). Foramen ovale puncture, lesioning accuracy, and avoiding complications: Microsurgical anatomy study with clinical implications. Journal of Neurosurgery, 119(5), 1176–1193. doi:10.3171/2013.1.JNS12743 PMID:23600929 Peters, G., & Nurmikko, T. J. (2002). Peripheral and gasserian ganglion-level procedures for the treatment of trigeminal neuralgia. The Clinical Journal of Pain, 18(1), 28–34. doi:10.1097/00002508-20020100000005 PMID:11803300 Pollock, B. E. (2012). Surgical management of medically refractory trigeminal neuralgia. Current Neurology and Neuroscience Reports, 12(2), 125–131. doi:10.100711910-011-0242-7 PMID:22183181 Rasminsky, M. (1978). Ectopic generation of impulses and cross-talk in spinal nerve roots of “dystrophic” mice. Annals of Neurology, 3(4), 351–357. doi:10.1002/ana.410030413 PMID:208454 Rasmussen, P. (1990a). Facial pain. II. A prospective survey of 1052 patients with a view of: Character of the attacks, onset, course, and character of pain. Acta Neurochirurgica, 107(3-4), 121–128. doi:10.1007/ BF01405790 PMID:2077848 Rasmussen, P. (1990b). Facial pain. I. A prospective survey of 1052 patients with a view of: Definition, delimitation, classification, general data, genetic factors, and previous diseases. Acta Neurochirurgica, 107(3-4), 112–120. doi:10.1007/BF01405789 PMID:2077847

627

 V2 Rhizotomy

Rasmussen, P. (1991). Facial pain. IV. A prospective study of 1052 patients with a view of: Precipitating factors, associated symptoms, objective psychiatric and neurological symptoms. Acta Neurochirurgica, 108(3-4), 100–109. doi:10.1007/BF01418516 PMID:2031469 Revuelta-Gutiérrez, R., Morales-Martínez, A. H., Mejías-Soto, C., Martínez-Anda, J. J., & Ortega-Porcayo, L. A. (2016). Microvascular decompression for glossopharyngeal neuralgia through a microasterional approach: A case series. Surgical Neurology International, 7(1), 51. doi:10.4103/2152-7806.181824 PMID:27213105 Ro, L.-S., & Chang, K.-H. (2005). Neuropathic pain: Mechanisms and treatments. Chang Gung Medical Journal, 28(9), 597–605. PMID:16323550 Salama, H., Ben-Khayal, H., Mohamed, M. A. S., El-Mitwalli, A., Zaher, A. A., Ezzeldin, A., & ... . (2009). Outcome of medical and surgical management in intractable idiopathic trigeminal neuralgia. Annals of Indian Academy of Neurology, 12(3), 173–178. doi:10.4103/0972-2327.56317 PMID:20174498 Samadian, M., Bakhtevari, M. H., Nosari, M. A., Babadi, A. J., & Razaei, O. (2015). Trigeminal Neuralgia Caused by Venous Angioma: A Case Report and Review of the Literature. World Neurosurgery, 84(3), 860–864. doi:10.1016/j.wneu.2015.04.063 PMID:25968963 Shelden, C. H., Pudenz, R. H., Freshwater, D. B., & Crue, B. L. (1955). Compression rather than decompression for trigeminal neuralgia. Journal of Neurosurgery, 12(2), 123–126. doi:10.3171/ jns.1955.12.2.0123 PMID:14368343 Sidebottom, A., & Maxwell, S. (1995). The medical and surgical management of trigeminal neuralgia. Journal of Clinical Pharmacy and Therapeutics, 20(1), 31–35. doi:10.1111/j.1365-2710.1995.tb00622.x PMID:7775611 Singh, B., Srivastava, S. K., & Dang, R. (2001). Anatomic considerations in relation to the maxillary nerve block. Regional Anesthesia and Pain Medicine, 26(6), 507–511. doi:10.1097/00115550-20011100000004 PMID:11707787 Skirving, D. J., & Dan, N. G. (2001). A 20-year review of percutaneous balloon compression of the trigeminal ganglion. Journal of Neurosurgery, 94(6), 913–917. doi:10.3171/jns.2001.94.6.0913 PMID:11409519 Smith, H. P., McWhorter, J. M., & Challa, V. R. (1981). Radiofrequency neurolysis in a clinical model. Neuropathological correlation. Journal of Neurosurgery, 55(2), 246–253. doi:10.3171/jns.1981.55.2.0246 PMID:7252548 Smyth, P., Greenough, G., & Stommel, E. (2003). Familial trigeminal neuralgia: Case reports and review of the literature. Headache, 43(8), 910–915. doi:10.1046/j.1526-4610.2003.03172.x PMID:12940815 Sola, C., Raux, O., Savath, L., Macq, C., Capdevila, X., & Dadure, C. (2012). Ultrasound guidance characteristics and efficiency of suprazygomatic maxillary nerve blocks in infants: A descriptive prospective study. Paediatric Anaesthesia, 22(9), 841–846. doi:10.1111/j.1460-9592.2012.03861.x PMID:22587691 Solaro, C., Messmer Uccelli, M., Uccelli, A., Leandri, M., & Mancardi, G. L. (2000). Low-dose gabapentin combined with either lamotrigine or carbamazepine can be useful therapies for trigeminal neuralgia in multiple sclerosis. European Neurology, 44(1), 45–48. doi:10.1159/000008192 PMID:10894995

628

 V2 Rhizotomy

Solaro, C., Uccelli, M. M., Brichetto, G., Gaspperini, C., & Mancardi, G. (2001). Topiramate relieves idiopathic and symptomatic trigeminal neuralgia. Journal of Pain and Symptom Management, 21(5), 367–368. doi:10.1016/S0885-3924(01)00275-5 PMID:11398791 Son, B.-C., Kim, H.-S., Kim, I.-S., Yang, S.-H., & Lee, S.-W. (2011). Percutaneous radiofrequency thermocoagulation under fluoroscopic image-guidance for idiopathic trigeminal neuralgia. Journal of Korean Neurosurgical Society, 50(5), 446–452. doi:10.3340/jkns.2011.50.5.446 PMID:22259692 Sweet, W. H., & Wepsic, J. G. (1974). Controlled thermocoagulation of trigeminal ganglion and rootlets for differential destruction of pain fibers: Part 1: Trigeminal neuralgia. Journal of Neurosurgery, 40(2), 143–156. doi:10.3171/jns.1974.40.2.0143 PMID:4587949 Taarnhøj, P. (1952). Decompression of the trigeminal root and the posterior part of the ganglion as treatment in trigeminal neuralgia; preliminary communication. Journal of Neurosurgery, 9(3), 288–290. doi:10.3171/jns.1952.9.3.0288 PMID:14939059 Taha, J. M., & Tew, J. M. Jr. (1996). Comparison of surgical treatments for trigeminal neuralgia: Reevaluation of radiofrequency rhizotomy. Neurosurgery, 38(5), 865–871. doi:10.1097/00006123-19960500000001 PMID:8727810 Tartaro, S., Stroffolini, F., & Lepore, M. (1979). The importance of etiology for the successful treatment of secondary trigeminal neuralgia. Reviews of some clinical cases. Journal of Medicine, 10(1-2), 121–128. PMID:290724 Tew, J. M., Jr., & Taha, J. M. (1995). Percutaneous rhizotomy in the treatment of intractable facial pain (trigeminal, glossopharyngeal, and vagal nerves). In Operative Neurosurgical Techniques (3rd ed.). Philadelphia: WB Saunders. Tronnier, V. M., Rasche, D., Hamer, J., Kienle, A. L., & Kunze, S. (2001). Treatment of idiopathic trigeminal neuralgia: Comparison of long-term outcome after radiofrequency rhizotomy and microvascular decompression. Neurosurgery, 48(6), 1261–1267, discussion 1267–1268. PMID:11383728 Türp, J. C., & Gobetti, J. P. (1996). Trigeminal neuralgia versus atypical facial pain. A review of the literature and case report. Oral Surgery, Oral Medicine, Oral Pathology, Oral Radiology, and Endodontics, 81(4), 424–432. doi:10.1016/S1079-2104(96)80018-7 PMID:8705588 Wang, J. Y., Bender, M. T., & Bettegowda, C. (2016). Percutaneous Procedures for the Treatment of Trigeminal Neuralgia. Neurosurgery Clinics of North America, 27(3), 277–295. doi:10.1016/j. nec.2016.02.005 PMID:27324995 Weiss, A. L., Ehrhardt, K. P., & Tolba, R. (2017). Atypical Facial Pain: A Comprehensive, Evidence-Based Review. Current Pain and Headache Reports, 21(2), 8. doi:10.100711916-017-0609-9 PMID:28251523 White, J. C., & Sweet, W. H. (1969). Pain and the neurosurgeon: A forty-year experience. Charles C. Thomas. Wu, C.-Y., Meng, F.-G., Xu, S.-J., Liu, Y.-G., & Wang, H.-W. (2004). Selective percutaneous radiofrequency thermocoagulation in the treatment of trigeminal neuralgia: Report on 1860 cases. Chinese Medical Journal, 117(3), 467–470. doi:10.1142/S0192415X04002120 PMID:15043796

629

 V2 Rhizotomy

Xu, S.-J., Zhang, W.-H., Chen, T., Wu, C.-Y., & Zhou, M. (2006). Neuronavigator-guided percutaneous radiofrequency thermocoagulation in the treatment of intractable trigeminal neuralgia. Chinese Medical Journal, 119(18), 1528–1535. PMID:16996006 Yang, J.-T., Lin, M., Lee, M.-H., Weng, H.-H., & Liao, H.-H. (2010). Percutaneous trigeminal nerve radiofrequency rhizotomy guided by computerized tomography with three-dimensional image reconstruction. Chang Gung Medical Journal, 33(6), 679–683. PMID:21199613 Zakrzewska, J. M. (2010). Medical management of trigeminal neuropathic pains. Expert Opinion on Pharmacotherapy, 11(8), 1239–1254. doi:10.1517/14656561003767449 PMID:20426709 Zakrzewska, J. M. (2016). Chronic/Persistent Idiopathic Facial Pain. Neurosurgery Clinics of North America, 27(3), 345–351. doi:10.1016/j.nec.2016.02.012 PMID:27325001 Zakrzewska, J. M., Jassim, S., & Bulman, J. S. (1999). A prospective, longitudinal study on patients with trigeminal neuralgia who underwent radiofrequency thermocoagulation of the Gasserian ganglion. Pain, 79(1), 51–58. doi:10.1016/S0304-3959(98)00145-6 PMID:9928776 Zakrzewska, J. M., & Patsalos, P. N. (2002). Long-term cohort study comparing medical (oxcarbazepine) and surgical management of intractable trigeminal neuralgia. Pain, 95(3), 259–266. doi:10.1016/ S0304-3959(01)00406-7 PMID:11839425

This research was previously published in Effective Techniques for Managing Trigeminal Neuralgia edited by Steven Chang and Allen Ho, pages 216-242, copyright year 2018 by Medical Information Science Reference (an imprint of IGI Global).

630

631

Chapter 31

Effecting Superior Pain Management Strategies by Combining Technology With Tradition CK Foo Honorary Health Informatics, Australia

ABSTRACT Today we are witnessing a significant rise in chronic diseases and chronic pain. Modern medicine appears not to be sufficient to relieve symptoms and reduce or eliminate discomfort. The following proffers the need to look at alternate strategies. In particular, it suggests that a solution might lie if we combine modern technology with ancient wisdom and traditional approaches. This chapter serves to highlight strategies for prudent pain management. “Pain is not just from physical disorders but also from combinations of physiological, pathological, emotional, psychological, cognitive, environmental, and social factors. The keys to successful pain control are the mechanisms that initiate and maintain pain.” “Now, the public and health professionals expect to control pain by using preventive and active strategies, including drugs and physical and psychosocial interventions.” (Holdcroft & Power, 2003).

INTRODUCTION Pain is a very good servant but a bad master. – Author unknown Everybody knows what pain is but no one really knows how to switch it off especially when it becomes persistent and annoying. Pain is not just from physical disorders but also from combinations of physiological, pathological, emotional, psychological, cognitive, environmental, and social factors. The keys to successful pain control are the mechanisms that initiate and maintain pain. Now, the public and health professionals expect to DOI: 10.4018/978-1-5225-7122-3.ch031

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Effecting Superior Pain Management Strategies by Combining Technology With Tradition

control pain by using preventive and active strategies, including drugs and physical and psychosocial interventions. (Holdcroft & Power, 2003). Have we lost sight of the real pathophysiology that underlies the phenomenon of pain? Are we concentrating on the end point rather than the cause of the malady? Drugs and physical therapies don’t have all the answers to pain management. Is there another way? Maybe we should take a broader look at why the pain started in the first place and then we can work out the solution to the health challenge!

BACKGROUND Pain arises when a living tissue is injured and the tissue responds with “inflammation”. Inflammation involves a cascade of events involving cells, enzymes, cytokines and chemokines and other substances, which will initiate other secondary responses by other cells and blood vessels. Inflammation is the beginning of the process of repair and healing. Ancient civilisations used different modalities to manage pain. They used physical therapies, medicinal foods and herbs where appropriate. Over the past century the pain and its management have changed dramatically. In this article I propose to discuss the reasons for the change in pain experience and will explore the practical aspects of pain management using the best from the “East & West”. While the scientists are dwelling deeply into the complex issues of pain and inflammation, patients in pain need help and advice now. Drugs alone cannot relieve all the pains and sufferings, surgical and psychological treatment may help some but for most, a holistic approach may help to reduce or relieve the pain and suffering.

The Role of Food for Health and Wellbeing We Are What We Eat If we supply our body with inappropriate or inferior quality materials, the tissues and structures so made will be of inferior quality. Deficiency diseases like scurvy and rickets have been known to cause deformed tissues and cause pain with different characters. By correcting the deficiencies these maladies can be cured. In our modern society it seems like more people are experiencing and suffering in pain. Is it because the newer generations are made of ‘weaker’ materials or is it that the pain threshold is reduced or the background inflammation in the body system has heightened? The fact that we have not been able to quantify and identify the missing ingredients in chronic pain, it should not deter us from searching for an answer by going “back to basics”. Our body is created to function efficiently and effectively when it is provided with all the nutrients it needs.

Modern Medical Model of Pain Management In modern medicine pain is treated with analgesics and non-steroidal anti- inflammatory drugs. If the pain persists, then stronger narcotics and anti-inflammatory corticosteroids are used. Other drugs like anti-depression and anti-epilepsy drugs are often used in pain clinics to help modulate the pain experience. Unfortunately, all these medications have unwanted side effects. There is a growing awareness in

632

 Effecting Superior Pain Management Strategies by Combining Technology With Tradition

the community that drug therapy is not the only way. People are looking for more natural alternatives, less harmful treatment modalities with more self-help involvement. They want to participate actively in the healing process. People are turning more and more to Alternative and Natural Therapies like physical therapies, (which include Physiotherapy, Osteopathy, Chiropractic) with stretching, mobilisation, manipulations, heat/cold packs and acupuncture/acupuncture related techniques, along with diet and nutritional supplements, to help manage their painful conditions.

Traditional Medical Model of Pain Management In Traditional Chinese Medicine (TCM), diseases develop when the flow of Qi (Energy, Prana, Life Force) is blocked or interrupted. The basis of TCM treatment is to re-establish the flow of Qi. The TCM Practitioners use needle acupuncture and or herbal remedies to alter or re-establish the flow of Qi to reestablish homeoestasis in the body (Chen, 1981; X. Cheng, 1987). The Qi or Life Force is also derived from the air we breathe, the water and food we drink and eat. Proper breathing and nutrition form part of the total management in TCM to help bring the body back into balance. It is well known that the food we eat determines how we feel. There are certain foods that will initiate or aggravate the painful situation. Food sensitivities and intolerance can trigger inflammatory response and cause pain (Author’s Clinical Observation & Treatment Protocol (unpublished), 2000).

Alternative Therapies Given the often poor results from modern medicine alone, many patients and their practitioners are now exploring how to combine modern medical approaches, strategies afforded to us today by technology with alternate strategies.

Acupuncture, LLLT, and TENS Since 1974, acupuncture is an accepted treatment method in pain clinics around the world. There is only one slight draw back with acupuncture. Not many people, given a choice would like to have needles stuck into them. So scientists went into intensive research for a non-invasive acupuncture-point stimulation methods. In the east, traditional health practitioners used manual massage, Shiatsu, AnMo and Tui Na to stimulate the tissues and acupoints. Scientists discovered two modalities that can stimulate acupoints through the skin without inflicting pain by using Low Level LASER Therapy (LLLT) (Baxter & Waylonis, 1995; Noe, 1990; Wong & Fung, 1991) and Transcutaneous Electrical Nerve Stimulation (TENS). Both these techniques are well accepted by the patients, as needles are not used. There is evidence that these methods of acupoint stimulation may give some of the benefits of needle acupuncture treatment. Though TENS was introduced more than 30 years ago as an alternative therapy to pharmacological treatments for chronic pain and in spite of its widespread use, the effectiveness of TENS is still rather controversial. A meta-analysis was carried out by the scientists in 2001 and the results were published in the Cochrane Database Systemic Reviews which showed that there was no evidence to support the use of TENS in the treatment of chronic low back pain while the results for chronic pain was inconclusive. Convention TENS stimulation has its limitation because of habituation from repetitive monotonous stimulation over the same points (Godfrey, 1988). However, the Canadian research scientists were able to

633

 Effecting Superior Pain Management Strategies by Combining Technology With Tradition

overcome this habituation by using a novel machine called Codetron ® which uses 6 negative electrodes and one positive electrode. At any one time a pair of electrodes is stimulated. The sequence of stimulation is randomised so that the brain will not filter out the stimulation and will accept each individual stimulation as a novel one. Controlled studies were done comparing Codetron with Sham Codetron therapy (Fargas-Babjak, Rooney, & Gerecz, 1989) and Codetron with Electroacupuncture (R. Cheng & Pomeranz, 1986). The findings were very favourable towards Codetron Therapy.

Diet, Nutrition, and Pain Management Over the recent years many reports were published stating that certain types of food would cause or aggravate arthritic or rheumatic pain. Childers et al in their article “An Apparent Relation of Nightshades (Solanaceae) to Arthritis” (Childers & Margoles, 1993) suggested that Solanaceae can cause pain in at least two known ways. Firstly, the alkaloids in these food can act alone or with other cholinesterase inhibitors (caffeine or food impurities containing systemic cholinesterase inhibiting pesticides), can cause muscle spasm, aches and pain, tenderness, inflammation and stiffness of body movements. Secondly because Solanaceae can develop the very active metabolite of vitamin D3 (1a25 dihydroxycholecalciferol) which can cause calcinosis of soft tissues, ligaments, and tendons, mineralization in walls of major arteries and veins, and osteopetrosis and related pathology in livestock. Over a period of time these cause progressions to lameness and extended uselessness, with eventual death of livestock (Childers & Margoles, 1993). It was reported that 28% of arthritis sufferers had a “marked positive response” and another 44% had a “positive response’ when they eliminated nightshades from their diet over a period of a few months (Childers & Margoles, 1993). In my clinical practice, a high percentage of rheumatic and arthritic patients improved just by avoiding the nightshade plants in their diet. The response can be as quick as a few weeks (Author’s Clinical Observation & Treatment Protocol (unpublished), 2000). Though rheumatoid arthritis (RA) is listed as an ‘auto-immune disease’, it may be linked to food allergies and sensitivities (Zeller, 1949). In some RA patients the pain is made worse when they eat foods to which they are allergic or sensitive to, and vice versa when these foods are avoided the patients feel better (Author’s Clinical Observation & Treatment Protocol, 2000; Beri, Malaviya, Shandilya, & Singh, 1988; Darlington et al., 1991; Panush, 1988; Taylor, 1983). It is estimated that one-third of people with RA patients can control the disease completely through allergy elimination (Darlington et al., 1991).

Inflammation and Foods Inflammation, with the accompanying features of redness, swelling, warmth and pain, is the basic way living tissues react to injury, irritation or infection. This is a form of nonspecific immune response. The foods we eat have a powerful bearing on our health and specifically, inflammation. Some foods we eat are pro-inflammatory while others are anti- inflammatory. With the advent of fast food industries our normal balanced inflammatory index diet has shifted towards 30 times more pro-inflammatory when compared with our forefathers’ diet. As a consequence, nowadays it is not surprising to note more people are suffering from different rheumatic type pain. One of the contributing factors could be the type of foods we eat and how we prepare out foods. To win the war against inflammation we have to turn the tide and go back to eating what Mother Nature wants us to eat – Fresh Living Natural Foods!

634

 Effecting Superior Pain Management Strategies by Combining Technology With Tradition

Fats, Oils, and Anti-Inflammatory Foods Extremely low-fat diets have been reported to help people with RA (Lucas & Power, 1981) and very low fat, pure vegetarian diets have also proved helpful (Nenonen, Helve, & Hanninen, 1992; Skoldstam, 1986). While polyunsaturated fats like n-3 fatty acids and n-6 fatty acids of Evening Primrose oil are helpful, oily fatty greasy fried foods are known to be pro-inflammatory and can aggravate inflammation and intensify pain. Vegetable oils heated to high temperature can turn into pro-inflammatory oil. There are many foods that are known to be pro-inflammatory in nature and wherever possible they should be avoided by people who suffer from aches and pains. Some of the common foods are milk products, wheat and wheat products, red meat, eggs, preservatives, additives and colorings, sugars and caffeine drinks (Author’s Clinical Observation & Treatment Protocol, 2000; Kjeldsen-Kragh et al., 1991; Warmbrand, 1971). In a laboratory experiment, Tall & Raja demonstrated that rats fed with soy protein diet had significantly less inflammation in their paws following an injection of Freud’s adjuvant as well as having a higher tolerance to heat compare with those rats fed with casein-fed animals (Tall & Raja, 2002). These results are consistent with previous research showing consumption of a soy-containing diet suppressed the development of pain following nerve injury (Shir, Raja, Weissman, Campbell, & Seltzer, 2001). Preliminary evidence suggests that consumption of olive oil, rich in oleic acid, may decrease the risk of developing RA (Linos et al., 1999). One trial in which people with RA received either fish oil or olive oil, found those olive oil capsules providing 6.8 g of oleic acid per day for 24 weeks produced modest clinical improvement and beneficial changes in immune function. However, as there was no placebo group in that trial, the possibility of a placebo effect cannot be ruled out (Kremer et al., 1990). Our forefathers used to eat food containing higher proportion of n-3 fatty acids. It was suggested that the ratio of n-3 fatty acids: n-6 fatty acids, was in the region of 1:1. Nowadays with intensive farming and chemical fertilisation the ratio of n-3 fatty acids: n-6 fatty acids is closer to 1:30. Possibly because of the skewed ratio more people are suffering more aches and pains in our society. To help correct this imbalance, it will be prudent for us to eat more n-3 fatty acids, which are found in deep-sea fish and flaxseed oil. Omega 3 fatty acid is used by the cells to keep cellular and nuclear membranes soft and pliable for the cells to function properly. Omega 3 fatty acid is also converted into Prostaglandin E(3) (PGE 3) which is a potent anti-inflammatory eicosanoids. Omega-6 fatty acid, which is found in vegetable oil, is converted to either Prostaglandin E (1) (PGE1) or Prostaglandin E (2) (PGE2). PGE1 is a strong anti-inflammatory eicosanoid while PGE (2) is pro-inflammatory eicosanoids. Through proper diet and supplement with flaxseed oil, and fish oil it is possible to improve the n-3:n-6 fatty acids ratio and increase anti-inflammatory eicosanoids in the body (Author’s Clinical Observation & Treatment Protocol (unpublished), 2000; James, Gibson, & Cleland, 2000). When we eat fatty red meat, egg yolks and organ meat we are consuming Arachidonic acids. This particular polyunsaturaed fat may be the most dangerous fat known when consumed in excess and is known as an Omega 6 fat. Arachidonic acid is converted to Prostoglandin E2 by an enzyme Cycloxygenase-2 (COX-2). A safe way to reduce production of Prostoglandin E2 is to follow a low Arachidonic acid diet and to take nutrient supplements like resveratrol, green tea extract, silymarin and quercetin.

635

 Effecting Superior Pain Management Strategies by Combining Technology With Tradition

Arthritis pain is cause by destruction of the joint cartilage. Leukotriene B4 destroys joint cartilage. The enzyme that converts arachidonic acid to leukotriene B4 in the body is called 5-LOX (5-lipoxygenase) (Martel‐Pelletier et al., 2004; Sampson, 2009). Again to inhibit 5-LOX and the production of leukotriene B4 is to follow a low-arachidonic-acid diet and to take supplement with like curcumin, boswellia, fish oil and krill oil (Chambers, 2011). Krill oil helps to reduce infiltration of inflammatory cells into the joint and joint-lining tissues, which reduces the pain, swelling, and loss of function in arthritis. Ageing often results in accelerated loss of protective joint cartilage. Nutrients that help rebuild cartilage include glucosamine, chondroitin, and MSM (methylsulfonylmethane). These nutrients are unlikely to achieve complete results if chronic inflammatory factors continue attacking joint cartilage.

Free Radicals and Antioxidants Many painful conditions like arthritis, fibrositis and fibromyalgia are due oxidative disorder due to free radical attacks. Increased free radical levels may be responsible for the development of many painful inflammatory conditions such as Rheumatoid Arthritis, Fibromyalgia, Osteoarthritis and different rheumatic painful conditions (Bagis et al., 2005; Packer, Hiramatsu, & Yoshikawa, 1999). There is a wide range of Antioxidants found naturally in the foods we eat and the herbs and spices we use for cooking. The most well-known ones are Vitamin C and Vitamin E Complex. They play a major role in supporting the other antioxidants activity in the body. Free radical attack causes damage to the cell structure through disrupting the stable cellular membranes. Inherently a free radical is an unstable molecule with one or two missing electrons. Free radical will try and snatch an electron from another stable molecule and by so doing it will cause a chain reaction of free radical attacks on the tissues, leading to damage to the tissue structure. The body tissues have an endogenous antioxidant system and will try and repair the free radical tissue damage. When DNA is damaged by the free radicals and it cannot be repaired, the disrupted genetic coding will duplicate without any central control. This is how cancer cells develop and multiple. Supplements with vitamins, minerals, phytonutrients such as carotenoids, flavonoids and cruciferous which contain potent anti-oxidants have proven to be very effective in quenching the free radical attacks. When we eat a wide variety of fresh colourful fruits and vegetables we are providing our body with a basket of antioxidant that will help neutralise the free radical activities and protect the cells from further damage (Packer et al., 1999). Over the recent years, scientists have been looking at different phytonutrients in foods and plants that we consume in our diet. One such product is Pygnogenol (Procyanidins and Catechin) extracted from the French Maritime Pine Bark. It is a very potent antioxidant and is also a strong anti-inflammatory agent, which will helps relieve many painful conditions. Anthocyanins, procyanidins and quercetins are also found in the grape skins and grape seeds. Another antioxidant that has proven to have both antioxidant and anti-inflammatory properties has given great relief to people with different pain conditions is Xanthones. Xanthones are flavonoids and are found in some fruits and bark of trees but the highest concentration is found in the pericarb of the Mangosteen fruit. There are 200 known Xanthones and 44 of them are found in the pericarb of the mangosteen fruit. Through personal communication by Dr. Vaughn T Johnson, DO who told me of his open study on patients who had elevated C-Reactive Protein CRP), an inflammatory marker. After putting them on the whole Mangosteen fruit puree for one month, 29 out of 30 of the patients’ CRPs returned to normal. This 636

 Effecting Superior Pain Management Strategies by Combining Technology With Tradition

suggests that the phytonutrients in the Mangosteen fruit puree containing Xanthones have a potent antiinflammatory property. Many diseases are caused by inflammation and if there are substances in nature that will help reduce inflammation, people should consider taking these food-source phytonutrients to help reduce inflammation in order to prevent the development of medical diseases (Bagis et al., 2005). Traditional health practitioners also use herbs and spices to treat painful conditions to reduce inflammation. Herbs like bupleurum, ginseng, licorice, ginger, cat’s claw, guggul, curcumin, bromelain have potent anti-inflammatory action and hence have helped patients with painful conditions (Benito et al., 1998).

FUTURE RESEARCH DIRECTIONS It is heartening to note that the patients and health practitioners are looking at alternative ways to help to manage their illnesses including pain. Combining technology and tradition for pain management is moving in the right direction. Present modern treatment methods have leveled off. Using stronger drugs to control pain is not the way to go. Taking a closer look at what is causing the seemingly increased number of people suffering from ‘aches and pains’ may help us to find a less invasive and maybe more effective solution to the painful problem. Inflammation holds the key to the painful problem. If we can reduce the background inflammation by changing our lifestyle, our diet and nutrition to a more inflammatory neutral living, pain will be similarly reduced to a soft background tingle! More and more people and growing number of health practitioners are looking at alternative ways to help relieve pain. Using the scientific knowledge and the modern technology and integrate with some ‘old fashion’ remedies from Mother Nature, will see us winning the war against pain. It would be most beneficial for future research to focus on how to develop an evidence base of how effective it is in pain management to combine traditional approaches with modern technology.

CONCLUSION We live in an exciting but challenging time. The evolution of technology is outstripping the slow Darwinian’s process of evolution. Things are moving too fast, the background noise is too loud, the light and the colour are too dazzlingly bright. The poor body is trying to cope with the massive changes. The body, so to speak, is not ready for the 21st century! As a consequence of these massive changes, a new group of medical diseases have evolved. Pain, an unpleasant sensation, has grown ‘louder and stronger’ in the modern society. People are relying on stronger drugs, more intensive physical therapy and latest technology to combat pain. Technology driven solutions alone are not necessarily the optimal answer but a combination of both old and new from the ‘East and West’ may affect superior pain management strategies. Holistic medicine is the wave of the present and the future. It is good medicine to “first do no harm” and to encourages the patients to be actively involved in the healing process using healing foods and herbs provided by the benevolent hands of Mother Nature. This integrative approach will ultimately lead to better practice of medicine and a superior quality of outcome.

637

 Effecting Superior Pain Management Strategies by Combining Technology With Tradition

REFERENCES Author’s Clinical Observation & Treatment Protocol (unpublished). (2000). Bagis, S., Tamer, L., Sahin, G., Bilgin, R., Guler, H., Ercan, B., & Erdogan, C. (2005). Free radicals and antioxidants in primary fibromyalgia: An oxidative stress disorder? Rheumatology International, 25(3), 188–190. doi:10.100700296-003-0427-8 PMID:14689230 Baxter, C. D., & Waylonis, G. W. (1995). Therapeutic Lasers: Theory and Practice. American Journal of Physical Medicine & Rehabilitation, 74(4), 327. doi:10.1097/00002060-199507000-00013 Benito, P. B., Martinez, M. A., Sen, A. S., Gómez, A. S., Matellano, L. F., Contreras, S. S., & Lanza, A. D. (1998). In vivo and in vitro anti-inflammatory activity of saikosaponins. Life Sciences, 63(13), 1147–1156. doi:10.1016/S0024-3205(98)00376-2 PMID:9763210 Beri, D., Malaviya, A., Shandilya, R., & Singh, R. (1988). Effect of dietary restrictions on disease activity in rheumatoid arthritis. Annals of the Rheumatic Diseases, 47(1), 69–72. doi:10.1136/ard.47.1.69 PMID:3278696 Chambers, T. (2011). Why So Many Arthritis Sufferers Fail to Find Relief. Life Extension Magazine. Chen, C. (1981). Acupuncture: a comprehensive text, Shanghai college of traditional medicine. Shanghai: Eastland Press. Cheng, R., & Pomeranz, B. (1986). Electrotherapy of chronic musculoskeletal pain: Comparison of electroacupuncture and acupuncture-like transcutaneous electrical nerve stimulation. The Clinical Journal of Pain, 2(3), 143–150. doi:10.1097/00002508-198602030-00001 Cheng, X. (1987). Chinese acupuncture and moxibustion. Beijing: Foreign Languages Press. . Childers, N., & Margoles, M. (1993). An apparent relation of nightshades (Solanaceae) to arthritis. Journal of Neurological and Orthopaedic Medicine and Surgery, 14, 227–227. Darlington, L., Ramsey, N., Helliwell, P., Rewilak, A., Maberly, D. J., & Anthony, H. (1991). Diets for rheumatoid arthritis. Lancet, 338(8776), 1209–1210. doi:10.1016/0140-6736(91)92074-C PMID:1682618 Fargas-Babjak, A., Rooney, P., & Gerecz, E. (1989). Randomized trial of Codetron for pain control in osteoarthritis of the hip/knee. The Clinical Journal of Pain, 5(2), 137–142. doi:10.1097/00002508198906000-00002 PMID:2520394 Godfrey, C. (1988). Antihabituation: a new modality for chronic pain relief. Paper presented at the Work presented at the International Congress of Rehabilitation Medicine, Toronto, Canada. Holdcroft, A., & Power, I. (2003). Management of pain. British Medical Journal, 326(7390), 635–639. doi:10.1136/bmj.326.7390.635 PMID:12649239 James, M. J., Gibson, R. A., & Cleland, L. G. (2000). Dietary polyunsaturated fatty acids and inflammatory mediator production. The American Journal of Clinical Nutrition, 71(1), 343s–348s. PMID:10617994

638

 Effecting Superior Pain Management Strategies by Combining Technology With Tradition

Kjeldsen-Kragh, J., Borchgrevink, C., Laerum, E., Haugen, M., Eek, M., Forre, O., ... Hovi, K. (1991). Controlled trial of fasting and one-year vegetarian diet in rheumatoid arthritis. Lancet, 338(8772), 899–902. doi:10.1016/0140-6736(91)91770-U PMID:1681264 Kremer, J. M., Lawrence, D. A., Jubiz, W., Digiacomo, R., Rynes, R., Bartholomew, L. E., & Sherman, M. (1990). Dietary fish oil and olive oil supplementation in patients with Rheumatoid Arthritis clinical and immunologic effects. Arthritis and Rheumatism, 33(6), 810–820. doi:10.1002/art.1780330607 PMID:2363736 Linos, A., Kaklamani, V. G., Kaklamani, E., Koumantaki, Y., Giziaki, E., Papazoglou, S., & Mantzoros, C. S. (1999). Dietary factors in relation to rheumatoid arthritis: A role for olive oil and cooked vegetables? The American Journal of Clinical Nutrition, 70(6), 1077–1082. PMID:10584053 Lucas, C. P., & Power, L. (1981). Dietary-fat aggravates active rheumatoid-arthritis. Paper presented at the Clinical research. Martel‐Pelletier, J., Mineau, F., Fahmi, H., Laufer, S., Reboul, P., Boileau, C., ... Pelletier, J. P. (2004). Regulation of the expression of 5‐lipoxygenase–activating protein/5‐lipoxygenase and the synthesis of leukotriene B4 in osteoarthritic chondrocytes: Role of transforming growth factor β and eicosanoids. Arthritis and Rheumatism, 50(12), 3925–3933. doi:10.1002/art.20632 PMID:15593193 Nenonen, M., Helve, T., & Hanninen, O. (1992). Effects of uncooked vegan food” living food” on rheumatoid arthritis, a three-month controlled and randomised study. The American Journal of Clinical Nutrition, 56, 762. Noe, J. M. (1990). Low Level Laser Therapy: A Practical Introduction. Plastic and Reconstructive Surgery, 85(5), 824. doi:10.1097/00006534-199005000-00040 Packer, L., Hiramatsu, M., & Yoshikawa, T. (1999). Antioxidant food supplements in human health. Academic Press. Panush, R. (1988). Possible role of food sensitivity in arthritis. Annals of Allergy, 61(6 Pt 2), 31–35. PMID:3061320 Sampson, A. P. (2009). FLAP inhibitors for the treatment of inflammatory diseases. Current opinion in investigational drugs, 10(11), 1163-1172. Shir, Y., Raja, S. N., Weissman, C. S., Campbell, J. N., & Seltzer, Z. e. (2001). Consumption of soy diet before nerve injury preempts the development of neuropathic pain in rats. The Journal of the American Society of Anesthesiologists, 95(5), 1238–1244. PMID:11684996 Skoldstam, L. (1986). Fasting and vegan diet in rheumatoid arthritis. Scandinavian Journal of Rheumatology, 15(2), 219–221. doi:10.3109/03009748609102091 PMID:3749829 Tall, J., & Raja, S. (2002). Inflammatory pain induced by complete Freund’s adjuvant in rats is suppressed by dietary soy. The Journal of Pain, 3(Suppl. 1), 45. PMID:14622853 Taylor, M. (1983). Food allergy as an etiological factor in arthropathies: A survey. J. Internat. Acad. Prev. Med., 8, 28–38.

639

 Effecting Superior Pain Management Strategies by Combining Technology With Tradition

Warmbrand, M. (1971). How Thousands of My Arthritis Patients Regained Their Health. Arco Publishing Company. Wong, T. W., & Fung, K. P. (1991). Acupuncture: From needle to laser. Family Practice, 8(2), 168–170. doi:10.1093/fampra/8.2.168 PMID:1874364 Zeller, M. (1949). Rheumatoid arthritis; food allergy as a factor. Annals of Allergy, 7(2), 200. PMID:18114844

KEY TERMS AND DEFINITIONS Anti-Oxidants: Chemical substances that donate an electron to the free radical and convert it to a harmless molecule. Auto-Immune Disease: Normally the immune system protects us from disease and infection but if our immune system turns around and mistakenly attacks ‘ourselves’ an autoimmune disease ensues. Autoimmune diseases can affect many parts of the body like the connective tissues, nerves, muscles, endocrine system and digestive system. Codetron: Has been classified as Acupuncture-Like TENS. The effect of this machine is equal to or better than electroacupuncture therapy. Eicosanoid: Lipid mediator of inflammation derived from the 20-carbon atom Arachidonic Acid (20 in Greek is “eicosa”) or a similar fatty acid. The eicosanoids include the prostaglandins, prostacyclin, thromboxane, and leukotrienes. Free Radical: An atom or molecule, which has an “unpaired electron” in the outer ring. An “unpaired electron” will also always mean that there is an odd number since “pairing” of electrons goes by 2s. Free radicals are highly reactive molecules and cause damage to nearby cells causing a cascade of chain reaction of free radical damage to other cells and tissues. Inflammation: A basic way in which the body reacts to infection, irritation or other injury, the key feature being redness, warmth, swelling and pain. LLLT: Or Low Level Laser Therapy (also known as Low Power Laser Therapy) is the application of red and near infra-red light over injuries or lesions to improve wound / soft tissue healing and give relief for both acute and chronic pain non healing wounds, post-op pain and acupoint stimulation. First developed in 1967, it is now commonly referred to as LLLT. The red and near infrared light (600nm1000nm) commonly used in LLLT can be produced by laser or high intensity LED. The intensity of LLLT lasers and LED’s is not high like a surgical laser. There is no heating effect. Nightshade Plants: Solanaceae (Nightshade Family) has been highly cultivated over the years - it includes potatoes, tomatoes, eggplant, sweet peppers, chili peppers (but not black pepper), tobacco and petunias. Some plants have great medicinal value, some are quite poisonous. The calyx and corolla are 5-lobed, and usually there are 5 stamens. The fruit is partitioned into 2 or 4 seed-producing divisions, and may be dry or a fleshy berry. Pygnogenol: The patented trade name for a water extract of the bark of the French maritime pine (Pinus pinaster ssp. atlantica). Pygnogenol contains oligomeric proanthocyanidins (OPCs) as well as several other Bioflavanoids: catechin, epicatechin, Phenolic fruit acids and taxifolin. Procyanidins are oligomeric catechins are also found in red wine, grapes, cocoa, cranberries, and apples. Pygnogenol helps the integrity of the blood vessels, skin, mental function as well as being a potent antioxidant. 640

 Effecting Superior Pain Management Strategies by Combining Technology With Tradition

Qi: (Pronounced as ‘chee’). Qi is proposed to regulate a person’s spiritual, emotional, mental, and physical balance and to be influenced by the opposing forces of Yin (negative energy) and Yang (positive energy). Disease is proposed to result from the flow of Qi being disrupted and Yin and Yang becoming imbalance. TENS: Transcutaneous Electrical Nerve Stimulation. produces neuro-modulation through the following pathways: (1) Presynaptic inhibition in the dorsal horn of the spinal cord (2) Endogenous pain control (via endorphins, Enkaphalins, and Dynorphins) (3) Direct inhibition of an abnormally excited nerve. (4) Restoration of afferent input. The results of laboratory studies suggest that electrical stimulation delivered by a TENS unit reduces pain through nociceptive inhibition at the Presynaptic level in the dorsal horn, thus limiting its central transmission. The electrical stimuli on the skin preferentially activate low- threshold myelinated nerve fibers. The afferent input from these fibers inhibits propagation of nociception carried in the small unmyelinated C fibers by blocking transmission along these fibers to the target or T cells located in the Substantia Gelatinosa (laminae 2 and 3) of the dorsal horn. Xanthones: Close cousins to the polyphenols family and have strong antioxidant effects on the nervous system. They are found in several botanical tonics including St. John’s wort, gentian root nectar and mangosteen. Current research on Xanthones suggests they are beneficial in helping with many conditions including allergies, infections (microbial, fungus, viral), cholesterol levels, inflammation, skin disorders, gastro-intestinal disorders, and fatigue. Xanthones have also been found to support and enhance the body’s immune system and exhibit strong antioxidant activity, which is beneficial for neutralizing free radicals in the body.

This research was previously published in the Handbook of Research on Healthcare Administration and Management edited by Nilmini Wickramasinghe, pages 407-417, copyright year 2017 by Medical Information Science Reference (an imprint of IGI Global).

641

642

Chapter 32

Manage My Pain:

A Patient-Driven Mobile Platform to Prevent and Manage Chronic Postsurgical Pain Aliza Weinrib Toronto General Hospital, University Health Network, Canada Muhammad Abid Azam York University, Canada & Toronto General Hospital, University Health Network, Canada Vered Valeria Latman York University, Canada Tahir Janmohamed ManagingLife, Canada Hance Clarke Toronto General Hospital, University Health Network, Canada Joel Katz York University, Canada & Toronto General Hospital, University Health Network, Canada

ABSTRACT This chapter describes the Manage My Pain digital pain management platform and its integration into the Transitional Pain Service at Toronto General Hospital. A collaboration between ManagingLife, the developer of Manage My Pain, and the Transitional Pain Service led to the creation of a patient-provider virtual community with the aim of managing complex pain after surgery so as to prevent the transition from acute post-surgical pain to chronic post-surgical pain. User engagement, motivation, and satisfaction are discussed with respect to the needs of (1) people living with pain and (2) health care providers. Challenges in implementation are described, along with new features developed for the digital platform as a result of the partnership between ManagingLife and the Transitional Pain Service.

DOI: 10.4018/978-1-5225-7122-3.ch032

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Manage My Pain

INTRODUCTION Cindy was diagnosed with severe fibromyalgia in 1996 after a shoulder injury -- in addition, she was suffering from pain due to severe whiplash, spinal stenosis, arthritis, bone spurs, degenerative disc disease, and multiple sclerosis. An orthopedic surgeon informed her she would require surgery on her back and neck; however, she was unable to afford health insurance, and surgery was not an option. The prospect of living with severe pain for the rest of her life, and not being able to work to support herself financially, left her feeling depressed and made it difficult to hope for recovery and a life without pain (ManagingLife, 2012). In 2011, a doctor suggested that Cindy keep a “health journal” to track her symptoms and manage her painful conditions. The health journal was useful but time-consuming and paperwork-heavy. She looked for a smartphone application that would be more effective and convenient and discovered the app, Manage My Pain. The app enabled her to track important information to manage her pain on a daily basis such as symptoms, pain triggers, and treatments for her pain – all with little hassle and in just a few minutes. Tracking and visualizing her pain through the app helped her learn more about her chronic pain. Moreover, she was able to share her data with her doctors. Manage My Pain helped Cindy create a patient-provider virtual community, which ultimately enhanced her ability to effectively manage her chronic pain (ManagingLife, 2012). Cindy’s struggle with chronic pain resembles that of hundreds of millions of chronic pain sufferers around the world. Unable to afford or access pain management services, many people are left to suffer alone, desperate, and impaired. The implementation of a virtual community within the pain management domain presents the dual opportunities of reducing barriers to chronic pain management for people living in pain, and optimizing the delivery of effective treatment by pain clinicians. This chapter chronicles the integration of the award-winning digital pain management platform, Manage My Pain, into an innovative hospital-based pain service to create a patient-provider virtual community with the aim of preventing and managing chronic pain after surgery.

BACKGROUND The Burden of Chronic Pain The silent epidemic (Wall & Jones, 1991) of pain is a source of tremendous personal suffering, disability, and healthcare expense. Globally, 20% of the population lives with chronic pain, with one-third reporting that their pain is severe (Breivik, Eisenberg, & O’Brien, 2013; Goldberg & McGee, 2011; Schopflocher, Taenzer, & Jovey, 2011). Chronic pain is generally defined as pain that persists beyond three to six months (Katz, Pagé, Fashler, Rosenbloom, & Asmundson, 2014; Treede et al., 2015), exceeding the expected timeframe for tissues to heal after injury, surgery, or illness (e.g., cancer). When pain becomes chronic, it can become a primary disorder in its own right: due to changes in pain processing in the central nervous system, pain itself is now the problem, rather than signaling the presence of other underlying physical or medical conditions (Siddall & Cousins, 2004; Tracey & Bushnell, 2009). Once pain becomes chronic, its course is expected to be long-term and possibly even life-long. Treatments are focused on pain reduction and self-management, rather than cure. 643

 Manage My Pain

The burden of chronic pain is best illustrated by a recent study of more than 24,000 communitydwelling individuals comparing those with chronic pain to those with other chronic diseases (Hogan, Taddio, Katz, Shah, & Krahn, 2016a). The decrement in quality of life associated with chronic pain was lower than for most other chronic diseases including heart disease, diabetes, and chronic obstructive pulmonary disease (Hogan et al., 2016a). Moreover, chronic pain is associated with high rates of mood (Arnow et al., 2006) and anxiety disorders (Katz, Pagé, Fashler, Rosenbloom, & Asmundson, 2014). The financial costs of chronic pain are a substantial burden to individuals as well as to the health care system. In the US, direct and indirect costs associated with medical care and lost work productivity are estimated at between $560 - $635 billion annually, exceeding costs associated with heart disease, cancer, and diabetes (“The National Academies Press”, 2011). In Canada, the annual, incremental direct healthcare cost to manage chronic pain was reported to be $1,742 per patient or a total of ~$11.5 billion each year, and this does not include the indirect costs associated with lost productivity (Hogan, Taddio, Katz, Shah, & Krahn, 2016b). The gold standard treatment for chronic pain is comprehensive care (Gatchel & Okifuji, 2006; Scascighini, Toma, & Sprott, 2008) involving multidisciplinary pain specialists, most often pain physicians, pain psychologists, and physiotherapists. Unfortunately, comprehensive pain treatment clinics are scarce and overburdened with high caseloads and long wait times (Fashler et al., 2016). With 1 in 5 Canadian adults living with pain (Schopflocher et al., 2011), the ratio of chronic pain patients to Canadian pain treatment facilities is estimated at 52,000:1 (Fashler et al., 2016). These data illustrate that access to appropriate, specialized pain treatment facilities is unacceptably low; as a consequence, many individuals are struggling to manage their chronic pain and communicate about their pain to non-specialist physicians.

Manage My Pain: A Mobile Platform for Chronic Pain Sufferers Manage My Pain (MMP), developed by ManagingLife, is a digital platform that allows people living with pain to quickly and easily track their pain on a daily basis using a natively designed and responsive app on their Android smartphones, or a responsively-designed web-app through their mobile or desktop browser. Data is instantly summarized in graphs that show trends and trajectories. This summarized data can be shared with health care providers in person or remotely, creating a virtual community between the individual living with pain and their health care provider. A key design principle of this digital platform is, first and foremost, to meet the needs of people living with pain, so that they find the app intuitive and beneficial. Since MMP was launched in 2012, over 24,000 people have created an account and recorded their pain. In total, over 544,000 pain episodes have been documented by users (Figure 1). Until 2016, MMP was downloaded solely by individuals who were self-motivated to track their pain, and digital pain diaries were shared with providers at the user’s initiative. In 2016, ManagingLife began a partnership with an innovative pain service, the Transitional Pain Service (TPS) at Toronto General Hospital, and this marked a new stage in the application of MMP. As part of this partnership, each patient treated by the pain service would be asked to use the digital platform to record their pain on an ongoing basis, and to communicate their pain and other ratings to their specialized pain team. The goal of this ongoing project is to improve the quality of care provided as well as patient outcomes. As the partnership between ManagingLife and this clinical service evolved, new features, which will be described later, were added to MMP in consultation with the multidisciplinary pain team. The virtual community formed as a result of this partnership between Managing Life and the Transitional Pain Service, using the MMP application, is a community that links the individual patient to 644

 Manage My Pain

Figure 1. The Manage My Pain digital platform for patients and health professionals. ©ManagingLife, 2017

their pain care team, which includes patient coordinators, acute-care nurses, physicians specializing in persistent pain, pain psychologists, and physiotherapists targeting recovery after surgery. Preece (2000) defines a virtual community as one that is composed of individuals satisfying their needs (as our patients are doing post-surgery) or performing their special roles (as our pain team health providers are doing). These individuals must have a reason to form a community – in our case, enhancing post-surgical pain management and patient support after hospital discharge, to allow for open communication regardless of distance, continuity of care, and pro-active and preventative management. In a virtual community, there must be policies to govern interaction (e.g., patients are asked to complete their electronic pain diary once per day). Finally, a computer system is needed which supports social interaction within the community, in this case the MMP application, available as a mobile e-health application or a web-based platform that can be accessed from any web-enabled device. This virtual community has both ‘virtual’ and ‘physical’ aspects (El Morr & Kawash, 2007), as patients and providers encounter each other both in the virtual space provided by the digital platform and in the physical space of the pain clinic, at visits that occur bi-weekly or monthly during the six months after surgery. In terms of degree of cooperation (El Morr, 2010), within this virtual community patients provide information and are aware of the engagement of their health providers in the virtual community. Responses to key information come in the form of phone calls between clinic visits in response to actionable health changes, as well as medication changes and so on at clinical visits based on patient self-report using the digital platform. Unlike many virtual communities that are either patient centered (in which patients largely communicate with one another, perhaps guided by a health professional) or professional centered (in which health professionals communicate with one another to build a knowledge network; El Morr, 2010), this virtual community links the patient and his or her specialist pain team, so that continuity of care after surgery can be enhanced, and key information can be shared instantly and with minimal effort among all health care providers in the multidisciplinary pain clinic. This VC has advantages that are consistent with those of health VCs at large: continuity of care, empowering patients and supporting self-managed care, and managing knowledge (in terms of patient’s pain information over time, for example; El Morr, 2010).

645

 Manage My Pain

A Clinical Partner: The Transitional Pain Service at Toronto General Hospital The TPS (Katz et al., 2015) was founded in 2014 within one of the largest surgical centers in Canada, Toronto General Hospital. The mission of TPS is to offer timely and effective intervention to patients who are at risk of developing chronic pain after undergoing necessary, life-saving procedures, including surgeries for cancer (e.g. thoracic, breast, gastrointestinal, head and neck), cardiac disease (e.g. coronary artery bypass graft, heart valve repair), or organ transplants (e.g. kidney, lung, liver, heart, pancreas). While acute pain after surgery is to be expected, between 10-50% of patients who undergo major surgery go on to develop chronic post-surgical pain – that is, post-surgical pain that continues for more than six months after surgery and possibly for years (CPSP; Katz & Seltzer, 2009; Kehlet, Jensen, & Woolf, 2006). The surgeries that pose the greatest risks for CPSP are usually associated with nerve damage leading to neuropathic pain (Katz & Seltzer, 2009). The one-year incidence of moderate-to-severe postsurgical pain has been estimated at 5 – 10%. The Transitional Pain Service aims to identify patients at high risk for chronic post-surgical pain, intervene before pain becomes chronic, and support these patients from the earliest days after surgery with state-of-the-art multidisciplinary pain care involving multimodal, opioid sparing medication prescribed by pain physicians and managed with the support of advanced practice nurses, behavioral interventions by pain psychologists, and physiotherapy and acupuncture provided by the physiotherapists specializing in post-surgical care. Prior to the development of this first-of-its-kind service, multidisciplinary, specialized pain management was not available to post-surgical patients. In fact, multidisciplinary pain care was only available once post-surgical pain had persisted for more than 6 months after surgery. Even then, the patient would need to be properly diagnosed with a chronic pain condition, and referred to a pain management clinic, with an average wait time of 18 months to be seen (Canadian Pain Coalition, 2014). Thus, a patient who developed persistent post-surgical pain could wait more than two years before seeing a pain specialist to optimize their pain treatments, at which point it is likely that pain would be entrenched, opioid medication dose may have escalated, and the patient could be suffering from disability, as well as mental health problems such as depression and anxiety.

The Partnership Between ManagingLife and the Transitional Pain Service The mission of the Transitional Pain Service is to provide state-of-the-art pain management for complex post-surgical pain from the earliest days after surgery. In order to bring this mission to full fruition, MMP serves an important function in facilitating communication between the patient and the health care team in the early, critical months after surgery. This collaborative project is being implemented to test the feasibility and acceptability of this virtual community to patients recovering from major surgery, with the hope that the mobilization of the virtual community will lead to improved long-term pain outcomes for patients. In addition to this being a clinical implementation project, the TPS has initiated several research projects, with the goal of assessing patient satisfaction and outcomes as a result of incorporating this virtual community into the clinical service. The goals of the partnership between ManagingLife and TPS are to (a) improve patient care and (b) develop and refine the virtual community with feedback from health care providers and patients. In working toward these goals, the digital platform itself has undergone a process of growth and change. The physicians, nurses, psychologists, physiotherapists, and patient coordinators of the pain service have 646

 Manage My Pain

participated, with the MMP development team, in a series of focus groups and consultations designed to optimize MMP. As part of this process, fruitful cross-pollination has occurred between the clinical service and the MMP development team, leading to the introduction of new features for this virtual community, which will be described below. In addition, the implementation of this virtual community within a large health care institution has presented challenges that will be discussed. Finally, an overview of future directions in the development of the virtual community will be provided.

USER CENTERED DESIGN: MEETING THE NEEDS OF PATIENTS AND HEALTH CARE PROVIDERS User centered design aims to create products that have a high degree of usability, defined as the “extent to which a product can be used by specified users to achieve specified goals with effectiveness, efficiency and satisfaction in a specified context of use” (“The International Organization of Standardization,” 1998). A usable product should be useful, efficient, effective, satisfying, learnable, and accessible (Rubin & Chisnell, 2008). This section will take a closer look at how the virtual community of MMP meets the needs of two key user groups, people with pain and health care providers, first by examining the patient user, and then by looking closely at the clinician user.

The User Living With Chronic Pain Apps designed for health care institutions risk low user engagement due to misalignment of patient needs with the apps’ functionality and user experience (Accenture, 2013). MMP was designed with the needs of the person in pain as a priority, and was first developed and launched as a mobile app for people living with chronic pain after intensive testing for functionality and user experience. It is essential that MMP meet the needs of the patient user, so that the user is engaged, motivated, and satisfied when recording their pain ratings. To meet the needs of the average person living with pain, it is important to understand who they are, what motivates them, and what they are looking for in a virtual community of this nature.

User Characteristics In Canada, the typical person with chronic pain is likely female, suffering from arthritis or low back pain, and with an average pain duration of 10 years (Moulin, Clark, Speechley, & Morley-Forster, 2002; Schopflocher et al., 2011). The average MMP user has similar characteristics: she is female, between 35 and 50 years of age, and reports one (or more) of five conditions: fibromyalgia, back pain, headaches (including migraines), arthritis, or neck pain. Users live around the world, as MMP has been translated into French, Spanish, German, Simplified Chinese, Korean, and Russian. The person with pain can enter pain records in one language (e.g., French), and their health professional can access the information shared in another language (e.g., German) – this has proved very useful in Switzerland (Ruppen, personal communication, 2012), for example, which has three official languages. A recent cluster analysis investigated and elucidated key characteristics of users of MMP (Rahman et al, 2017). This data mining analysis employed the k-means clustering algorithm and was based on a sample of more than 24,000 users (comprising more than 544,000 data points). Five clusters of users were found, with each cluster representing a different level of user engagement. The authors found that 647

 Manage My Pain

although MMP has more female users than male users overall, once males register to use the app, they are more likely to use the app over a longer period of time and with greater frequency than female users. This gender difference is consistent with gender differences reported in the utilization of mobile health technology (Zhang et al, 2013; Guo et al, 2015). Furthermore, the investigators found that highly engaged MMP users (1) were older than less engaged users, (2) had more diagnosed pain conditions, (3) were taking a higher number of pain medications, including (4) more opioid-based pain medication. While the cluster analysis was based on MMP users in the community, patients using MMP as part of care provided by the Transitional Pain Service have their own distinct profile. The average patient seen by the TPS is older, at 52 years of age on average. The gender balance of the TPS patients is 52.7% male and 47.3% female patients. These are complex patients with 65% having more than 3 major medical morbidities. Many patients report indicators of neuropathic pain, including burning, tingling, “electricshock”-like pain, and sensitivity to touch from bedsheets or clothing, due to damage to nerves sustained during surgery (Cousins, Power, & Smith, 2000). In order to facilitate ease of use, especially for users who may not be highly “tech savvy”, MMP was designed with the naïve user in mind and relies on visual cues, simple language, and customizable user-centric features to promote quick learnability and a frustration-free user experience. The app has been improved repeatedly based in part on user feedback. User feedback has been forthcoming through reviews on the Google Play store, as well as through direct messages to the developers through the “contact us” option within the app. The developers review all feedback and provide comments in response to users in order to ensure that users know that their feedback is valued and acted upon in improving the virtual community. User feedback has been utilized to improve the app’s flow and function whenever possible in the next update, and the application has undergone more than 60 iterations (based on the number of updates published on Google Play). The goal of each update is to improve the adoption rate and allow for a smooth, uncomplicated user experience. In addition, a brief, 5-question survey of 100 users who had used the app for at least 12 weeks was undertaken in March 2015 by ManagingLife to solicit feedback from MMP users. Users were asked to rate the utility of the app on a 5-point Likert scale in terms of meeting user needs, such as better characterizing their pain - in addition, users were invited to provide open ended feedback. As a result of ongoing feedback and consultation with users, user satisfaction is excellent, with the “pro” version of the mobile app earning 309 (59%) five star user ratings. Furthermore, MMP was designed to meet accessibility limitations that are present among many persons with chronic pain. Individuals with mobility issues can manage their records from the comfort of home, and can interact with the platform as much or as little as needed, depending on their pain level, mood, schedule, and other relevant factors.

User Motivations According to a user survey, people with pain reported four main reasons for using MMP. To Better Understand Their Pain People with pain often find their pain difficult to understand and predict. When pain is unpredictable, it is more aversive (Chapman, 2009), and therefore one of the key benefits that MMP users report is that the app helps them to better understand their own pain. The central feature of MMP is the “pain record” that enables users to efficiently and regularly enter details about their pain episodes, without

648

 Manage My Pain

overburdening them. Users are asked to complete only one item, a rating of pain intensity using a slider on a visual analogue scale (Figure 2). They have the option of completing seven more items regarding their present pain (see Figure 2) that together take less than one minute to complete. In addition, users are prompted daily to record their pain intensity and daily functioning. Over time, users can see the big picture – pain intensity over time, pain triggers presented by frequency, and daily functioning – as this information is presented visually using graphs and charts (Figure 3). To Provide Information to the Health Care Provider Since the causes of chronic pain have historically been poorly understood, patients with chronic pain report feeling dismissed, disbelieved and rejected by healthcare professionals (Newton, Southall, Raphael, Ashford, & LeMarchand, 2013). They may be concerned with insensitivity and negative judgment from health care professionals some of whom claim that the pain is all “in their head” (Dewar, White, Posade, & Dillon, 2003; Katz, Rosenbloom, & Fashler, 2015). MMP provides a safe space for users to record their pain and related symptoms without fearing stigma and judgment. The patient’s private pain is made visible and more concrete by summary charts and graphs, leading to improved communication about pain with their health care provider. One user stated: “Not only can I track my pain, but I can keep track

Figure 2. Manage My Pain page for adding a new pain record. ©ManagingLife, 2017

Figure 3. Manage My Pain pain severity tracking chart. ©ManagingLife, 2017

649

 Manage My Pain

of what triggers it, what makes it better, and even input my history. I recently had my initial appointment with a new doctor and all I had to do was pull out this magic app and my entire (complicated) history was readily available and sped the entire process along” (ManagingLife, 2016). To Have a Space Where They Can Discuss and Share Their Struggles For many people living with pain, pain interferes with daily life, including social activities with family and friends. Many chronic pain patients report feeling socially isolated and stigmatized (Dewar, Gregg, White, & Lander, 2009). When socially isolated, people with a variety of medical problems turn to virtual communities for support (Marco Leimeister, Schweizer, Leimeister, & Krcmar, 2008). One MMP user reflected on his use of the mobile app, and articulated the way in which it reduced his sense of isolation: “The psychological impact of being asked [by the app] how my day was at 8 pm every evening is ironically very comforting. It feels like I have a friend out there who wants to know how I am doing” (ManagingLife, 2016). To Support Insurance and Disability Claims Many people with chronic pain find themselves disabled by pain and without their previous means of employment and financial support. Therefore, one of their key benefits of using MMP is documentation of their pain to support claims for disability benefits. One user called MMP “my insurance sword!” and explained: “I can’t always remember everything since my accident. This program gives me the tool to schedule alarms to remind me to enter my pain and meds. Great reports to show doctor and insurance company the severity of my pain on a daily basis. Insurance companies can’t see your pain, but they can see a report. Your pain is real. This program allows you to be your own advocate” (ManagingLife, 2016).

The Clinician User People with pain may wish to share their pain records with a variety of health care practitioners or other stakeholders, including insurance companies. This section will focus on the clinicians who manage pain, describe their needs as users, and outline how the virtual community meets their needs.

Health Care Providers in Pain Management Effective pain management is best accomplished with a multidisciplinary team; therefore, a variety of health care professionals participate in this virtual community. These health care providers may include: • • • •

650

Generalist physicians in primary care, known as general practitioners, family doctors, or primary care physicians. Pain-specialist physicians – such as anesthesiologists, physiatrists, and psychiatrists – who have advanced training in pain medicine and often work out of specialized pain clinics or rehabilitation facilities. Nurses who treat pain patients in community clinics and hospitals, including advanced practice nurses who may manage medications. Practitioners focused on coping with pain and psychosocial functioning, including psychologists and social workers.

 Manage My Pain

• •

Other health care providers focused on physical functioning, such as physiotherapists, occupational therapists, kinesiologists, and exercise physiologists. Complementary and alternative medicine practitioners such as registered massage therapists, chiropractors, and yoga instructors.

The introduction of a virtual community into the TPS required an evaluation of the health care providers’ needs. To accomplish this, the developers conducted focus groups to assess the needs of the clinician stakeholders, including pain physicians, nurses, psychologists, physiotherapists and patient coordinators. They found that the various health care professionals have similar basic needs in terms of functionality from the virtual community (the needs of the patient coordinators will be discussed in more detail below). For example, pain physicians assess trends in pain intensity and daily activities to evaluate the impact of pain medications. The psychology team also tracks pain intensity and functioning, but uses these metrics differently: they look to pain intensity to assess in part how the patient is perceiving and evaluating their pain, and they look to functioning to track the impact of behavioral interventions aimed at helping the patient do more meaningful and important activities each day. The physiotherapist uses these same metrics with an eye to the impact of acupuncture and daily exercise on pain intensity and functioning. Some information is uniquely useful to certain health care practitioners. For example, advanced practice nurses and physicians are specifically focused on medication side effects, which patients can track on their phones using the mobile app. However, by and large, the information communicated from patients to clinicians within the virtual community is not segmented according to the profession of the clinician, and all clinicians are able to make use of the same interface.

Shared Needs Among Clinician Users The common ground among health care providers extends to their needs in using the platform. This section will review key needs of the clinician users and how they are addressed within the virtual community. Accurate Clinical Information Pain clinicians of all professions need accurate information regarding the patients’ pain. Traditionally, this information has been collected using paper-and-pencil questionnaires in clinic. For example, the average post-surgical pain patient comes to TPS once per month for pain assessment and medication consultation. At the monthly visit, the patient is asked to recall their pain over the past month and record their average pain using a standardized and validated questionnaire, e.g., Brief Pain Inventory (Cleeland & Ryan, 1994). This method is simple, low cost, and well-established; however, there are limitations to the accuracy of patient recall. The memory of pain is influenced by many factors (Redelmeier, Katz, & Kahneman, 2003). In one study (Ariely, 1998) patients were exposed to painful heat and pressure in the lab. If the pain ended on a high note, they remembered more pain than if the pain ended on a low note, even if they experienced the same amount of pain on average. In other words, the intensity of their most recent pain influenced their pain memory (Ariely, 1998). In another study (Eich, Reeves, Jaeger, & Graff-Radford, 1985), patients were asked how much pain they experienced over the previous week. Some of these patients were asked immediately after physiotherapy, which gave them pain relief, whereas others did not receive physiotherapy. The patients who had just competed physiotherapy remembered less pain over the previous week than

651

 Manage My Pain

the patients who did not have physiotherapy, even though their daily electronic pain diaries said that was not the case. In other words, their current pain relief influenced their pain memory (Eich et al., 1985). It is more accurate to have patients measure their pain in real time between clinic visits. Implementation of this approach is challenging, however, because daily paper-and-pencil diaries generate a lot of data on paper that is then time-consuming to analyze. One key advantage of MMP for the clinician user is that pain ratings can be collected in real-time in the patient’s own daily living environment (known as ecological momentary assessment), yielding pain data that is more accurate and precise. Furthermore, it has been shown that patients using digital pain diaries prefer them to paper-and-pencil diaries, with higher rates of patient satisfaction and compliance (Jamison et al., 2001). Analysis of Patient Trajectories The ability to assess the trajectory of a patient’s pain and functioning in an instant is invaluable for clinicians. Paper-and-pencil assessments collected at clinic visits provide valuable information; however, before meaningful analysis of trends in patient pain and functioning can be understood, the data must be entered into a digital database, total scores for questionnaires must be generated and interpreted, and trends over time must be analyzed (e.g., What is the patient’s functioning score today? Is it in the clinical range? Is it an improvement over their score last month?). This requires additional human resources, which are difficult to spare, given the pace and staffing of medical clinics. A key benefit of MMP is that digital data is readily analyzed. No additional labor is required for data entry, analysis or for graphing a patient’s pain intensity since the last appointment. Pain trajectories are at the doctor’s fingertips and clinicians can assess the impact of previous interventions (e.g., if a new drug was prescribed at the last visit, did pain intensity decrease?), identify at risk-patients (e.g., a patient whose pain is not decreasing adequately and as expected in the weeks after surgery), and – for clinicians involved in clinical research - export and utilize data for research purposes as appropriate. Time Efficiency Clinicians treat many patients in one day. Each patient requires high quality, personalized care in a timeefficient manner. Therefore, it is critical that the data collected through the digital platform be delivered to the clinician in a way that does not add to clinician burden, but rather supports the clinician in making efficient and effective decisions regarding the next steps in the overall pain management plan. The need of clinicians for time-efficient information delivery is met in this virtual community with one-screen (or one-page) summary reports that highlight the most clinically relevant variables using visual representation of data (e.g., color coded graphs) that can be read and understood in 30 seconds (Figure 4). In order to determine what information was most critical and actionable for clinicians from a variety of disciplines, a series of focus groups was conducted with participants from the pain service staff in the Department of Anesthesia and Pain Management and the Pain Research Unit at Toronto General Hospital. A total of approximately 20 health care providers and pain research scientists from a variety of disciplines (i.e., medicine, nursing, psychology, physiotherapy and patient coordinators) provided qualitative feedback on the contents of the one-page report. The health care providers and pain experts highlighted the most useful and important information, what information was missing and should be added, and gave qualitative feedback on the visual presentation of information. After each focus group, a new iteration of the report was created, which was once again available for comment at the next focus group. Three focus groups were conducted in total.

652

 Manage My Pain

Figure 4. Manage My Pain clinician report summary page. ©ManagingLife, 2017

653

 Manage My Pain

Remote Communication Most pain clinicians use paper-and-pencil assessments that can only be completed when the patient is in the same physical environment as the clinician. Between visits, there is generally little-to-no communication, unless a patient calls the clinic requesting urgent care. In contrast, within the virtual community, pain information can flow freely from patients to physicians at any time, including between visits. This is highly advantageous during the critical period after surgery, once patients are discharged from hospital. Patients who are seen by the TPS after surgery come from all over the province of Ontario. Returning to the hospital for follow up after surgery is particularly onerous when one has to travel far distances. Therefore, the value of this remote communication is even greater, as patients can keep their pain team apprised of their pain intensity and function at a distance, and make the most of appointments, which require great effort to attend.

CHALLENGES IN IMPLEMENTATION Integrating an externally-developed mobile health app into a clinical service based in a large healthcare institution comes with a multitude of challenges. In order to facilitate this integration, a close collaboration was needed to refine the features of the digital platform to support the creation of a virtual community that would meet the needs of clinical team members. As part of the implementation process, a series of consultations led to the development of new features for the digital platform, including (1) an assessment of patients’ daily functioning, (2) a secure web-based monitoring portal for the clinical team with features added specifically for patient coordinators tracking large numbers of patients, and (3) improved summaries of patient tracking and progress for clinicians. This section will describe these innovations in greater detail, followed by a discussion of our approaches to health data security, ownership, and safeguards for clinician’s data access and sharing. Finally, strategies for measuring the impact of deploying MMP on clinical outcomes will be described.

A Close Collaboration Leads to New Features for the Virtual Community Measuring Functioning With a Daily Reflection Prior to the collaboration between ManagingLife and TPS, the digital platform did an excellent job of measuring pain and related factors, but did not assess functioning. Functioning refers to the ability of people living with pain to perform daily self-care activities (e.g., bathe or shower, shop for groceries, prepare meals), participate in social activities (e.g., have coffee with a friend, attend community festivals), and perform occupational tasks (e.g., get to work, complete a project, participate in weekly volunteer work), as well as other activities that they find rewarding (e.g., play with grandchildren, learn Sudoku) (Turk et al., 2003). When assessing treatment progress in individuals with persistent pain, the measurement of functioning is critically important (Dworkin et al., 2008). Focusing solely on pain intensity as the main outcome of treatment can lead to reduced pain at the expense of escalating doses of opioid pain medication (Ballantyne & Sullivan, 2015). While pain intensity may be reduced, due to the serious side effects of opioid medication, the ability to participate in meaningful life activities may not improve, leading to little change

654

 Manage My Pain

in overall quality of life. Thus, without tracking both pain and functioning, the impact of treatment is difficult to determine. Importantly, in patients living with chronic pain, the intensity of pain does not map on to the severity of tissue damage. Once pain has become chronic, the intensity of chronic pain is more strongly associated with emotional and psychosocial factors, such as the perceived meaning of the pain (Ballantyne & Sullivan, 2015). Furthermore, when these psychosocial factors are targeted by behavioral interventions – a standard component of multidisciplinary pain care – then functioning can improve, even when pain intensity does not change (Vowles, Fink, & Cohen, 2014). For all these reasons, functioning is a very important outcome to measure. The TPS clinical team requested that functioning be measured via the digital platform. However, existing paper-and-pencil questionnaires that assess functioning didn’t mesh with the format of the mobile app and its design principles. For example, the World Health Organization Disability Assessment Schedule (World Health Organization, 2000) would take too long to complete daily on a mobile application. In order to minimize patient burden when assessing functioning, two key design principles were implemented: (1) completion of the measure within 60 seconds, (2) use of sliders and checkboxes for ease of use. The MMP team ran a focus group with each discipline represented on the clinical team (e.g., physicians, nurses, psychologists, and physiotherapists) to discuss what facets of functioning they wanted to assess. A study of validated measures of functioning was also undertaken. Finally, four two-hour workshops were conducted. Each workshop started with a mock-up of the new assessment of functioning, followed by reflection and discussion. At the end of this process, the functioning measure had been designed and was ready to be turned over to the developers to code and launch. The MMP development team and the multidisciplinary TPS clinical and research staff arrived at one question, which users are prompted to complete as a “Daily Reflection” at 8 pm daily: “What did you do that mattered to you today?” Below the question is a slider that users move to rate their day from 0 (i.e., “I did nothing that mattered to me today”) to 10 (i.e., “I did everything that mattered to me today”) (Figure 5). This formatting mimics the 0 to 10 rating of pain intensity that is familiar to MMP users. Below the slider, a series of checkboxes allow the user to quickly identify the specific meaningful activities they engaged in that day, such as spending time with people they care about or doing an activity that they enjoyed (Figure 5). Users can personalize their list of meaningful activities to reflect the activities that are most important to them (for one patient it could be gardening, whereas for another it might be volunteering). This feature is sensitive to improvements over the course of treatment. For example, one patient at Toronto General Hospital said that her life had changed as a result of the treatment that she received. Prior to treatment, she was so distressed due to her pain that she had suicidal thoughts. During the course of treatment, the patient’s engagement in meaningful daily activities increased by ~10% and she reported an increase of ~40% in terms of spending time with friends and family, getting support online or through texting, and exercising. This kind of engagement in personally meaningful activities is a key component of the behavioral treatment for pain. Acceptance and Commitment Therapy (Hayes, Strosahl, & Wilson, 2011), which is an empirically supported treatment for individuals living with chronic pain (“APA division 12”, 2013), emphasizes engagement in personally meaningful activities as a cornerstone of treatment (Polk, Schoendorff, Webster, & Olaz, 2016). Based on this model of behavioural treatment, which is used in the TPS clinic (Azam et al, 2017; Weinrib et al, 2017), the TPS team wanted to capture more than the activities of daily living (bathing, dressing, walking, etc.). The team wanted to capture activities that were based on personal values – a type of meaningful activity that is so important for quality of life, yet often not captured by existing measures of functioning. For example, one patient-user reported that 655

 Manage My Pain

Figure 5. Manage My Pain data entry page for daily reflections. ©ManagingLife, 2017

she very much wanted to sing, but hadn’t been able to do so due to her pain. After treatment, she was singing again, which was deeply meaningful to her and constituted a substantial improvement to her quality of life and functioning, but it is not an activity that would be captured by a standard functioning measure. In contrast, using the Daily Reflection feature, she could track her singing by including it as a personally meaningful activity. The new feature of the Daily Reflection was explained to users in a blog post by Dr. Aliza Weinrib, clinical psychologist at TPS. The blog explained: Sometimes, we can’t eliminate pain entirely. I know many of you are all too familiar with this very difficult situation! This is like when I am making soup and I add too much salt. The salt is in there and I can’t get it out! The only thing that I can do is add more of the other ingredients – more veggies, more beans, more broth. And then the soup tastes much better. In a similar way, even when you can’t get rid of the pain, you can add small, manageable, and meaningful activities to your day. Bit by bit, this can change the flavor of your life (Weinrib, 2016). It has yet to be shown, as the authors believe, that tracking meaningful activities using the Daily Reflections is, in itself, a helpful intervention for pain. It is well established that tracking behavior has an impact on behavior: “Just the process of tracking itself—often referred to as self-monitoring—can

656

 Manage My Pain

provide many benefits, including increased frequency of desired behaviors and decreased frequency of undesired behaviors, better understanding and awareness of one’s behavior and health patterns, and opportunistic engagement in desired behaviors” (Klasnja & Pratt, 2012, p. 186). When people with pain engage in personally meaningful and positive activities, they subsequently report less pain intensity (Hausmann, Parks, Youk, & Kwoh, 2014). In future, the TPS team will assess whether this feature is simply a method of tracking behavior, or has therapeutic impact itself by increasing engagement in meaningful activities and, consequently, improving quality of life.

Improved Summary Reports Since its inception, patients have been empowered by the MMP application to provide summary reports on their pain to their health care team. Once MMP was introduced to the clinical team at TPS, their feedback was incorporated to make the summary reports as user-friendly as possible for health care professionals from a variety of disciplines. Through a series of iterations and feedback sessions, the report was edited down to a single screen or page of highly visual information. One of the key pieces of feedback from the clinical team was that the absolute value of the patient’s pain intensity rating (e.g., 5/10) was not typically as important for the evaluation of the efficacy of clinical interventions as the change in the pain intensity rating (e.g., pain intensity has decreased one point on the 0-10 scale). For example, if a physician wanted to know if the patient had less pain since gabapentin was added to the medication regimen at the previous visit one month prior, he needed to see the change in pain values (e.g., pain intensity has gone down two points since the last clinic visit one month ago, in comparison to no change over the previous month). This did not involve any change in how information was collected from patients, but rather required a change in how pain information was analyzed and summarized for clinicians, making it much more useful in treatment planning.

Clinical Monitoring Portal In addition to the reports (discussed above) that can be generated at the time of the clinic visit for each patient, a substantial advantage of electronic data collection is that it can be viewed remotely and that patients can be monitored as a group. While the physicians, nurses, psychologists and physiotherapists are engaged in one-on-one patient care, the patient coordinators keep an eye on the needs of the patients as a whole – particularly tracking who may need urgent care. Monitoring patients through the web-based MMP clinician portal is therefore an extension of the role of the patient coordinators. Typically, tasks of the patient coordinators in a pain clinic include: (1) taking patient phone calls, (2) triaging concerns about pain and medication with the help of medical staff, (3) scheduling patients’ regular appointments and urgent care, (4) coordinating prescription renewals, (5) checking-in patients for medical appointments in the outpatient clinic, and (6) administering standardized paper-and-pencil questionnaires for program evaluation. Patient care coordinators are essential members of the team, particularly as they often are the first line of contact for patients expressing concerns about their pain and medications. The patient care coordinators from TPS met with the MMP team regarding the clinical monitoring portal. Under the supervision of a responsible physician, the portal allows them to track the post-surgical progress of the patients on the TPS active patient list, viewing pain trajectories in the critical weeks and months after surgery, and taking note of patients whose pain is not resolving and/or who are reporting concerning symptoms, such significant medication side effects. The patient coordinators requested an 657

 Manage My Pain

additional feature. They wanted to have the ability to create a list of patients to follow up as they reviewed patient progress, so that they would have a quick and efficient way to flag patients who require further pro-active follow up or intervention. They also requested the ability to easily search for patients by their hospital number. Both of these features were quickly implemented by the development team to allow for greater functionality and ease of use in monitoring the progress of the patients as a group.

Safeguarding Private Data: Our Approach to Health Data Access and Security One of the biggest hurdles in the implementation of the MMP platform at Toronto General Hospital was safe stewardship of patient health information. Both organizations take security and privacy very seriously and a lengthy consultation process was initiated with many stakeholders, including research ethics, the legal teams for the hospital and the digital platform, the hospital privacy office, the clinical and research staff of TPS, and the development team for MMP (notably, the hospital information technology department was not involved, as the possibility of integrating MMP data into the electronic medical record was not under consideration). Based on this consultation process, multiple safeguards were put in place to ensure patient data remains protected. These safeguards were formally documented in a legal contract between the two parties after approval by the Research Ethics Board (REB) at University Hospital Network (UHN), which oversees research activity at Toronto General Hospital. A written set of privacy procedures was put in place at UHN, and a UHN privacy officer was designated to be responsible for developing and implementing required policies and procedures. Key protections on electronic protected health information (EPHI) implemented as part of this project are reviewed below.

Data Security ManagingLife has implemented safeguards to ensure the security and privacy of patient data, which include but are not limited to: • • • • •

Transmission of data through a Secure Socket Layer and user authentication using a token-based system and encrypted credentials; Encryption of all data in transit and at rest; Regular cadence of security and compliance audits against all servers; Backing up all data daily off-site through an encrypted channel; Storage of all data in electronic format on Amazon Web Services (AWS) secure servers, protected by a firewall and multiple layers of operational and physical security to ensure the integrity and safety of data.

Sharing Patient Data With the Care Team The care team needed to connect a particular MMP user ID to a specific hospital ID number so that the TPS team would know which MMP user was which specific patient. After a patient undergoes surgery and is recovering in hospital, they are approached by a member of the TPS research team and asked if they would consent to participate in a study of the effectiveness of adding MMP to clinical care. If the patient is interested and gives consent, research staff then generate a unique random ID which they then give to the patient. The patient then goes online to register to use the virtual community and is asked to 658

 Manage My Pain

provide consent for MMP to share their data with TPS. At that point, their user ID is cross-referenced with the TPS patient list, so that the clinical service is aware that one of their patients has engaged with the mobile or web-based application and is voluntarily sharing data.

Authenticating the Clinical User It was important to define standard operating procedures to ensure that patient data was accessed only by authenticated clinical team members. Clinical users must create their own user name and password using their official UHN email address. A research coordinator must then confirm that this particular health professional is covered by the REB approval for TPS before assigning access, ensuring that only approved staff can access data collected via the virtual community. This ensures access to electronic protected health information is restricted only to employees who require access as part of their job function.

Access to Patient Data After TPS Treatment Has Ended Above and beyond its role in the collaboration with TPS, MMP as a mobile application can be downloaded by anyone, and the patient-user owns their data and controls data sharing. Ordinarily, this would mean that when a TPS patient who is using the platform is discharged from the TPS, his TPS care team would no longer have access to his data. However, given that one goal of this project is for the TPS team to evaluate the impact of deploying a virtual community, an arrangement was made that allowed for patient-user data to be retained and used by the institution for the duration of the study. The patient-user also has continued access to his or her data, and can continue to use the application as he or she wishes. In these ways, TPS and MMP have addressed concerns regarding the safeguarding of patients’ electronic private health information. Addressing these concerns to the satisfaction of all the key stakeholders was one of the major hurdles to overcome in order to implement this project. Figure 6 captures the end result of how the MMP app is used within TPS.

Measuring the Clinical Impact of Implementing a Virtual Community One of the challenges of implementation is measuring the impact of adding this virtual community to the standard clinical protocol. TPS researchers aim to evaluate whether engagement with MMP during post-surgical recovery improves patient outcomes. The hypothesis is that patients using MMP to share data with their pain management team after surgery will report less pain as well as less pain-related interference with daily activities at 6 months post-surgery when compared to a control group of patients who have not used the virtual community to communicate with their post-surgical pain specialists at TPS. In order to evaluate this outcome, TPS researchers will analyze matched cohorts of patients who participated in the virtual community versus those who did not. At the end of this project, researchers will also evaluate whether the virtual community improved patient and clinician satisfaction with care.

FURTHER INNOVATION AND FUTURE DIRECTIONS The partnership between ManagingLife and the Transitional Pain Service at Toronto General Hospital has led to multiple innovations in the collection and communication of health information for pain pa659

 Manage My Pain

Figure 6. Use of Manage My Pain within the Transitional Pain Service. ©ManagingLife, 2017

tients. Further innovations under development include (1) a pioneering system of “clinician alerts” that pro-actively signal clinically relevant trends to the patient’s care team and (2) the implementation of a peer-to-peer community in the future, in which patients living with pain will be able to connect, share, and support each other.

In Development: Clinician Alerts When patient pain data is gathered electronically and shared remotely, there are new possibilities in terms of how data are utilized to guide medical care. Based on patient self-reported pain data, a cutting-edge system of clinician alerts has been designed that will proactively capture and flag clinically significant trends and alert the care team. For example, the TPS team is concerned about indicators of neuropathic pain – such as “electric-shock” like pain, tingling, numbness, and burning sensations (Jensen et al., 2011) – because patients who report neuropathic pain indicators acutely after surgery are at higher risk for persistent pain one year later (Hayes, Browne, Lantry, & Burstal, 2002). Therefore, when patients record notable signs of neuropathic pain, an alert will be sent to the care team to flag this patient for follow up. Multimodal interventions can then be offered, including first line medications for neuropathic pain (e.g., gabapentin) and psychological interventions (e.g., mindfulness and relaxation) to calm the nervous system. The goal here is to use the digital platform to facilitate early multidisciplinary intervention and effective preventative health care in order to avert pain, suffering and increased health care costs

660

 Manage My Pain

in the future. The cost savings from preventing even one case of persistent chronic pain after surgery are substantial, as Cousins, Power, & Smith (2000) explained: “The savings that would accrue from the early detection and treatment in the postoperative period of a 30 year old patient who would otherwise progress to develop a persistent chronic pain syndrome and become a permanent burden on the health care system might initially amount to as much as $100,000 and to $.05 to $1 million during the rest of that individual’s life” (p. 6).

Future Directions: Peer-to-Peer Support Community Currently, the MMP virtual community supports communication between people living with pain and health providers. In future, the MMP development team envisions adding a peer-to-peer community that will facilitate support among people living with pain. People living with persistent pain greatly appreciate the opportunity to connect with others like themselves: “It is very difficult for anyone to understand the depth of … pain and the effect it has on your life and your loved ones until they have been there” (Rodham, McCabe, & Blake, 2009, p. 625). In addition, many people living with pain report that they have become more isolated as they are less mobile and participate in fewer social activities (Rodham et al., 2009). An internet-based support network may be a more accessible way to receive support from peers. Furthermore, there is some initial evidence that internet-based peer support forums may lead to improved clinical outcomes, such as reduced pain intensity and increased activity engagement (Bender, Radhakrishnan, Diorio, Englesakis, & Jadad, 2011). Some have gone so far as to say that the very intimate, often anonymous, self-disclosures that occurs in these types of virtual communities “offer a form of peer support that cannot be achieved face to face, and hence may represent a new form of treatment rather than a new method of delivery” (Bender et al., 2011, p. 1748). By adding a peer-support network to the MMP application, the goal is to expand the virtual community to facilitate the benefits associated with peer support.

CONCLUSION Individuals living with pain have been independently adopting and using the MMP digital platform to understand their pain and improve communication with their health care providers, demonstrating their self-started engagement with this virtual community. Now, with the collaboration between ManagingLife and the TPS at Toronto General Hospital, the virtual community is extending beyond individuals in pain to encompass the community of patients and providers who participate in this clinical service. The implementation of this virtual community as part of clinical care in the TPS has presented multiple challenges in implementation, as well as opportunities for growth and development. Even in the present age of digital supremacy, integrating a virtual community with digital data sharing into clinical care in a major hospital is a challenging and groundbreaking task. This endeavor showcases the leading-edge of eHealth advancement, and highlights the emerging role of virtual communities in the healthcare system.

661

 Manage My Pain

DISCLOSURE Dr. Aliza Weinrib, Ph.D., C.Psych, has served as the clinical psychology lead for the Transitional Pain Service since its inception in 2014. Dr. Weinrib received compensation for the development of original content for Manage My Pain through funding obtained from the Industrial Research Assistance Program (IRAP) of the National Research Council of Canada (NRC). Tahir Janmohamed is the founder and CEO of ManagingLife, Inc. Joel Katz and Hance Clarke are unpaid members of the ManagingLife Advisory Board, providing guidance on the product and the company’s research initiatives.

ACKNOWLEDGMENT The work described in this chapter was supported by the National Research Council of Canada (NRC) Industrial Research Assistance Program (IRAP) Small Project Grant (Project #868245) and Business Innovation Access Program (BIAP; Project #845829), as well as an Ontario Centres of Excellence award (Project #23905). Joel Katz is supported by a Canadian Institutes of Health Research Canada Research Chair in Health Psychology held at York University. Hance Clarke is supported by a Merit Award from the Department of Anesthesia, University of Toronto. Muhammad Abid Azam is supported by a Canadian Institutes of Health Research Canada Graduate Scholarship.

REFERENCES Accenture. (2013). Losing patience: Why healthcare providers need to up their mobile game. Retrieved from https://www.accenture.com/t20160629T221243__w__/us-en/_acnmedia/PDF-24/AccentureLosing-Patience.pdf#zoom=50 Acceptance and Commitment Therapy EST Status for Chronic or Persistent Pain: Strong Research Support. Society of Clinical Psychology (Division 12). (2013). Retrieved June 1, 2015, from http://www. div12.org/psychological-treatments/disorders/chronic-or- persistent-pain/acceptance-and-commitmenttherapy-for-chronic-pain/ Ariely, D. (1998). Combining experiences over time: The effects of duration, intensity changes and online measurements on retrospective pain evaluations. Journal of Behavioral Decision Making, 11(1), 19–45. doi:10.1002/(SICI)1099-0771(199803)11:13.0.CO;2-B Arnow, B. A., Hunkeler, E. M., Blasey, C. M., Lee, J., Constantino, M. J., Fireman, B., ... Hayward, C. (2006). Comorbid depression, chronic pain, and disability in primary care. Psychosomatic Medicine, 68(2), 262–268. doi:10.1097/01.psy.0000204851.15499.fc PMID:16554392 Azam, M. A., Weinrib, A. Z., Montbriand, J., Burns, L. C., McMillan, K., Clarke, H., & Katz, J. (2017). Acceptance and Commitment Therapy to manage pain and opioid use after major surgery: Preliminary outcomes from the Toronto General Hospital Transitional Pain Service. Canadian Journal of Pain, 1(1), 37–49. http://www.tandfonline.com/doi/full/10.1080/24740527.2017.1325317

662

 Manage My Pain

Ballantyne, J. C., & Sullivan, M. D. (2015). Intensity of chronic pain — The wrong metric? The New England Journal of Medicine, 373(22), 2098–2099. doi:10.1056/NEJMp1507136 PMID:26605926 Bender, J. L., Radhakrishnan, A., Diorio, C., Englesakis, M., & Jadad, A. R. (2011). Can pain be managed through the Internet? A systematic review of randomized controlled trials. Pain, 152(8), 1740–1750. doi:10.1016/j.pain.2011.02.012 PMID:21565446 Breivik, H., Eisenberg, E., & OBrien, T. (2013). The individual and societal burden of chronic pain in Europe: The case for strategic prioritisation and action to improve knowledge and availability of appropriate care. BMC Public Health, 13(1), 1229. doi:10.1186/1471-2458-13-1229 PMID:24365383 Chapman, R. R. (2009). Predictability of painful stimulation modulates subjective and physiological responses. The Journal of Pain, 11(3), 239–246. doi:10.1016/j.jpain.2009.07.009 PMID:19853519 Cleeland, C. S., & Ryan, K. M. (1994). Pain assessment: Global use of the Brief Pain Inventory. Annals of the Academy of Medicine, Singapore, 23(2), 129–138. PMID:8080219 Coalition, C. P. (2014). The painful truth: The truth of pain management in Canada. Retrieved from http://www.canadianpaincoalition.ca/media/painful_truth_report.pdf Cousins, M. J., Power, I., & Smith, G. (2000). 1996 Labat lecture: Pain—a persistent problem. Regional Anesthesia and Pain Medicine, 25(1), 6–21. PMID:10660235 Dewar, A., White, M., Posade, S. T., & Dillon, W. (2003). Using nominal group technique to assess chronic pain, patients perceived challenges and needs in a community health region. Health Expectations, 6(1), 44–52. doi:10.1046/j.1369-6513.2003.00208.x PMID:12603627 Dewar, A. L., Gregg, K., White, M. I., & Lander, J. (2009). Navigating the health care system: Perceptions of patients with chronic pain. Chronic Diseases in Canada, 29(4), 162–168. PMID:19804680 Dworkin, R. H., Turk, D. C., Wyrwich, K. W., Beaton, D., Cleeland, C. S., Farrar, J. T., ... Ader, D. N. (2008). Interpreting the clinical importance of treatment outcomes in chronic pain clinical trials: IMMPACT recommendations. The Journal of Pain, 9(2), 105–121. doi:10.1016/j.jpain.2007.09.005 PMID:18055266 Eich, E., Reeves, J. L., Jaeger, B., & Graff-Radford, S. B. (1985). Memory for pain: Relation between past and present pain intensity. Pain, 23(4), 375–380. doi:10.1016/0304-3959(85)90007-7 PMID:4088698 El Morr, C. (2010). Health Care Virtual Communities: Challenges and Opportunities. In C.-C. Maria Manuela, J. T. Antonio, & S. Ricardo (Eds.), Handbook of Research on Developments in E-Health and Telemedicine: Technological and Social Perspectives (pp. 278–298). Hershey, PA: IGI Global. doi:10.4018/978-1-61520-670-4.ch013 El Morr, C., & Kawash, J. (2007). Mobile virtual communities research: A synthesis of current trends and a look at future perspectives. International Journal for Web Based Communities, 3(4), 386–403. doi:10.1504/IJWBC.2007.015865 Fashler, S. R., Cooper, L. K., Oosenbrug, E. D., Burns, L. C., Razavi, S., Goldberg, L., & Katz, J. (2016). Systematic review of multidisciplinary chronic pain treatment facilities. Pain Research & Management, 2016, 1–19. doi:10.1155/2016/5960987 PMID:27445618

663

 Manage My Pain

Gatchel, R. J., & Okifuji, A. (2006). Evidence-based scientific data documenting the treatment and cost-effectiveness of comprehensive pain programs for chronic nonmalignant pain. The Journal of Pain, 7(11), 779–793. doi:10.1016/j.jpain.2006.08.005 PMID:17074616 Goldberg, D. S., & McGee, S. J. (2011). Pain as a global public health priority. BMC Public Health, 11(1), 770. doi:10.1186/1471-2458-11-770 PMID:21978149 Guo, X., Han, X., Zhang, X., Dang, Y., & Chen, C. (2015). Investigating m-health acceptance from a protection motivation theory perspective: Gender and age differences. Telemedicine Journal and e-Health, 21(8), 661–669. doi:10.1089/tmj.2014.0166 PMID:25919800 Hausmann, L. R. M., Parks, A., Youk, A. O., & Kwoh, C. K. (2014). Reduction of bodily pain in response to an online positive activities intervention. The Journal of Pain, 15(5), 560–567. doi:10.1016/j. jpain.2014.02.004 PMID:24568751 Hayes, C., Browne, S., Lantry, G., & Burstal, R. (2002). Neuropathic pain in the acute pain service: A prospective survey. Acute Pain, 4(2), 45–48. doi:10.1016/S1366-0071(02)00026-8 Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (2011). Acceptance and Commitment Therapy: The process and practice of mindful change. Guilford Press. New York, NY: Guilford Press. Retrieved from https:// contextualscience.org/ACT_Randomized_Controlled_Trials Hogan, M.-E., Taddio, A., Katz, J., Shah, V., & Krahn, M. (2016a). Health utilities in people with chronic pain using a population-level survey and linked healthcare administrative data. Pain. doi:10.1097/j. pain.0000000000000776 Hogan, M.-E., Taddio, A., Katz, J., Shah, V., & Krahn, M. (2016b). Incremental healthcare costs for chronic pain in Ontario, Canada – a population-based matched cohort study of adolescents and adults using administrative data. Pain, 157, 1. doi:10.1097/j.pain.0000000000000561 PMID:26447708 Jamison, R. N., Raymond, S. A., Levine, J. G., Slawsby, E. A., Nedeljkovic, S. S., & Katz, N. P. (2001). Electronic diaries for monitoring chronic pain: 1-year validation study. Pain, 91(3), 277–285. doi:10.1016/ S0304-3959(00)00450-4 PMID:11275385 Jensen, T. S., Baron, R., Haanpää, M., Kalso, E., Loeser, J. D., Rice, A. S. C., & Treede, R.-D. (2011). A new definition of neuropathic pain. Pain, 152(10), 2204–2205. doi:10.1016/j.pain.2011.06.017 PMID:21764514 Katz, J., Pagé, M. G., Fashler, S., Rosenbloom, B. N., & Asmundson, G. J. G. (2014). Chronic pain and the anxiety disorders: Epidemiology, mechanisms and models of comorbidity, and treatment. In Mental Health and Pain (pp. 119–155). Springer. doi:10.1007/978-2-8178-0414-9_8 Katz, J., Rosenbloom, B. N., & Fashler, S. (2015). Chronic pain, psychopathology, and DSM-5 somatic symptom disorder. Canadian Journal of Psychiatry, 60(4), 160–167. doi:10.1177/070674371506000402 PMID:26174215 Katz, J., & Seltzer, Z. (2009). Transition from acute to chronic postsurgical pain: Risk factors and protective factors. Expert Review of Neurotherapeutics, 9(5), 723–744. doi:10.1586/ern.09.20 PMID:19402781

664

 Manage My Pain

Katz, J., Weinrib, A., Fashler, S. R., Katznelzon, R., Shah, B. R., Ladak, S. S., … Clarke, H. (2015). The Toronto General Hospital Transitional Pain Service: Development and implementation of a multidisciplinary program to prevent chronic postsurgical pain. Journal of Pain Research, 8, 695–702. doi:10.2147/JPR.S91924 Kehlet, H., Jensen, T. S., & Woolf, C. J. (2006). Persistent postsurgical pain: Risk factors and prevention. Lancet, 367(9522), 1618–1625. doi:10.1016/S0140-6736(06)68700-X PMID:16698416 Klasnja, P., & Pratt, W. (2012). Healthcare in the pocket: Mapping the space of mobile-phone health interventions. Journal of Biomedical Informatics, 45(1), 184–198. doi:10.1016/j.jbi.2011.08.017 PMID:21925288 ManagingLife. (2012). Cindy’s coming to terms with chronic pain. Retrieved from https://www.managinglife.com/cindy ManagingLife. (2016). Manage My Pain (Version 2.63) [Mobile Application Software]. Retrieved from https://play.google.com/store/apps/details?id=com.lcs.mmp.full&hl=en#details-reviews Marco Leimeister, J., Schweizer, K., Leimeister, S., & Krcmar, H. (2008). Do virtual communities matter for the social support of patients? Antecedents and effects of virtual relationships in online communities. Information Technology & People, 21(4), 350–374. doi:10.1108/09593840810919671 Moulin, D. E., Clark, A. J., Speechley, M., & Morley-Forster, P. K. (2002). Chronic pain in Canadaprevalence, treatment, impact and the role of opioid analgesia. Pain Research & Management, 7(4), 179–184. doi:10.1155/2002/323085 PMID:12518174 Newton, B. J., Southall, J. L., Raphael, J. H., Ashford, R. L., & LeMarchand, K. (2013). A narrative review of the impact of disbelief in chronic pain. Pain Management Nursing, 14(3), 161–171. doi:10.1016/j. pmn.2010.09.001 PMID:23972867 Organization, W. H. (2000). World Health Organization disabilty assessment schedule: WHODAS II. Phase 2 field trials. Health Services Research. Polk, K., Schoendorff, B., Webster, M., & Olaz, F. (2016). The Essential Guide to the ACT Matrix: A Step-by-Step Approach to Using the ACT Matrix Model in Clinical Practice. Oakland, CA: New Harbinger Publications, Inc. Preece, J. (2000). Online communities: Designing usability supporting sociability. New York: John Wiley & Sons Ltd. Rahman, Q. A., Pirbaglou, M., Janmohamed, T., Ritvo, P., Heffernan, D., Clarke, H., & Katz, J. (2017). Data mining to determine patterns of user engagement with Manage My Pain, an mHealth App for Chronic Pain. Manuscript submitted. Redelmeier, D. A., Katz, J., & Kahneman, D. (2003). Memories of colonoscopy: A randomized trial. Pain, 104(1), 187–194. doi:10.1016/S0304-3959(03)00003-4 PMID:12855328 Rodham, K., McCabe, C., & Blake, D. (2009). Seeking support: An interpretative phenomenological analysis of an Internet message board for people with Complex Regional Pain Syndrome. Psychology & Health, 24(6), 619–634. doi:10.1080/08870440802563245 PMID:20205016

665

 Manage My Pain

Rubin, J., & Chisnell, D. (2008). Handbook of usability testing: how to plan, design and conduct effective tests. Hoboken, NJ: John Wiley & Sons. Scascighini, L., Toma, V., & Sprott, H. (2008). Multidisciplinary treatment for chronic pain: A systematic review of interventions and outcomes. 10.1093/rheumatology/ken021 Schopflocher, D., Taenzer, P., & Jovey, R. (2011). The prevalence of chronic pain in Canada. Pain Research & Management: The Journal of the Canadian Pain Society = Journal de La Société Canadienne Pour Le Traitement de La Douleur, 16(6), 445–50. Retrieved from http://www.pubmedcentral.nih.gov/ articlerender.fcgi?artid=3298051&tool=pmcentrez&rendertype=abstract Siddall, P. J., & Cousins, M. (2004). Persistent pain as a disease entity: Implications for clinical management. 10.1213/01.ANE.0000133383.17666.3A The National Academies Press. (2011). Relieving Pain in America: A Blueprint for Transforming Prevention, Care, Education, and Research. Washington, DC: The National Academies Press. Tracey, I., & Bushnell, M. C. (2009). How neuroimaging studies have challenged us to rethink: Is chronic pain a disease? The Journal of Pain, 10(11), 1113–1120. doi:10.1016/j.jpain.2009.09.001 PMID:19878862 Treede, R., Rief, W., Barke, A., Aziz, Q., Bennett, M. I., Benoliel, R., … Wang, S. (2015). A classification of chronic pain for ICD-11. Academic Press. Turk, D. C., Dworkin, R. H., Allen, R. R., Bellamy, N., Brandenburg, N., Carr, D. B., ... Galer, B. S. (2003). Core outcome domains for chronic pain clinical trials: IMMPACT recommendations. Pain, 106(3), 337–345. doi:10.1016/j.pain.2003.08.001 PMID:14659516 Usability of consumer products and products for public use - Part 2: Summative test method. (1998). Retrieved from https://www.iso.org/obp/ui/#iso:std:iso:ts:20282:-2:ed-2:v1:en Vowles, K. E., Fink, B. C., & Cohen, L. L. (2014). Acceptance and Commitment Therapy for chronic pain: A diary study of treatment process in relation to reliable change in disability. Journal of Contextual Behavioral Science, 3(2), 74–80. doi:10.1016/j.jcbs.2014.04.003 PMID:27818931 Wall, P. D., & Jones, M. (1991). Defeating pain: The war against a silent epidemic. New York: Plenum Press. Weinrib, A. (2016). Manage My Pain. Retrieved from https://www.managinglife.com/faq?id=9 Weinrib, A. Z., Azam, M. A., Birnie, K., Burns, L. C., Clarke, H., & Katz, J. (2017). (in press). The psychology of persisting post-surgical pain: New frontiers in risk factor identification, prevention, and management. British Journal of Pain. Zhang, X., Guo, X., Lai, K. H., Guo, F., & Li, C. (2014). Understanding gender differences in m-health adoption: A modified theory of reasoned action model. Telemedicine Journal and e-Health, 20(1), 39–46. doi:10.1089/tmj.2013.0092 PMID:24161004

666

 Manage My Pain

KEY TERMS AND DEFINITIONS Acute Pain: A type of pain that typically lasts for a short duration (i.e. less than 3 months). Chronic Pain: A type of pain that lasts for 3 or more months, outlasting the usual healing process. This pain can reoccur intermittently, get progressively worse, and can cause significant psychological and emotional suffering as well as disability. Chronic Postsurgical Pain: Chronic pain resulting from a surgical procedure that lasts beyond the expected postsurgical healing period (2 – 3 months), and excludes other sources of pain and pre-existing pain. Manage My Pain (MMP): A digital platform consisting of a mobile and web application used by sufferers of chronic pain to record, track, and analyze their pain information with the goal of helping them and their healthcare team better understand their symptoms and conditions. ManagingLife: A software company that has developed the Manage My Pain digital platform. Neuropathic Pain: Pain that is caused by damage or a disease in the somatosensory nervous system. Pain: An unpleasant sensory or emotional experience associated with actual or potential tissue damage. Toronto General Hospital (TGH): The Toronto General Hospital is part of the University Health Network as a major teaching hospital in downtown Toronto, and among the largest surgical centers in Canada. Transitional Pain Service (TPS): A multidisciplinary clinical service developed within the Toronto General Hospital (Toronto, Canada) with the mission of preventing and managing chronic postsurgical pain and supporting opioid tapering. The TPS consists of anesthesiologists, pain physicians, nursepractitioners, a psychologist, and a physiotherapist who are able to see patients before and after major surgeries. University Health Network (UHN): The University Health Network is a healthcare and research organization in Toronto, Ontario, Canada. It is one of the largest such research organizations in Canada and North America.

This research was previously published in Novel Applications of Virtual Communities in Healthcare Settings edited by Christo El Morr, pages 93-126, copyright year 2018 by Medical Information Science Reference (an imprint of IGI Global).

667

Section 10

Remote Monitoring, Mobile Health, and Medical Imaging

669

Chapter 33

Chronic Condition Management Using Remote Monitoring and Telehomecare Maximillian E. Stachura Georgia Regents University, USA Ellen B. Bolch THA Group, USA Katherine F. Piette THA Group, USA Joseph F. Ebberwein THA Group, USA

ABSTRACT Individuals afflicted with multiple chronic conditions should be managed in real life settings and real time, while simultaneously reducing use of costly acute care services. New models of care delivery will enable patient participation in life-long care management programs and activities that target “wellness” while minimizing, delaying, or preventing clinical deterioration that requires hospitalization and/or visits to emergency care facilities. Successful care models will likely require new organizational and financial approaches that re-purpose health professional roles, responsibilities, and relationships. Remote monitoring and telehomecare technologies that employ advanced data management and analytic algorithms as well as dashboard displays of clinician- and services-relevant health information will support clinician decision-making at the point and time of care. Optimally, health professional financial incentives will be re-structured to support and sustain outcomes-driven long term chronic care that rewards efficiency and effectiveness. We present a work-in-progress model, RightHealthTM, including pilot project outcomes.

DOI: 10.4018/978-1-5225-7122-3.ch033

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Chronic Condition Management Using Remote Monitoring and Telehomecare

INTRODUCTION Timely access to healthcare in both urban and rural settings is a worldwide challenge because no nation committed to the health of its population can afford to replicate in every community all the resources required for each community’s healthcare needs. Tele-networking of patients, providers, and relevant health information may be the only way to make healthcare services and outcomes-driven decisionmaking available, responsive, and convenient for consumers, practical for providers, and economically viable for healthcare systems. By definition, chronic conditions (CC) last a year or more, and limit activities of daily living and/or require on-going medical attention (Hwang, 2001). They include physical medical conditions, mental and cognitive disorders, developmental disabilities, and addiction disorders. The prevalence and burden of fifteen selected CC was summarized by the Centers for Medicare and Medicaid Services (CMS, 2013). Selected conditions (percentage of Medicare beneficiaries) included: Hypertension (58%), High Cholesterol (45%), Ischemic Heart Disease (31%), Arthritis (29%), Diabetes Mellitus (28%), Heart Failure (16%), Chronic Kidney Disease (15%), Depression (14%), Chronic Obstructive Pulmonary Disease (12%), Alzheimer’s Disease (11%), Atrial Fibrillation (8%), Cancer (8%), Osteoporosis (7%), Asthma (5%), and Stroke (4%). All are more prevalent in individuals 65 years of age or older, except depression and asthma. Multiple chronic conditions (MCC): •

Increase with age:

85(83%) •

Increase hospitalizations in a year:

0-1CC/MCC (4%/63% hospitalized; 3 hospitalizations): •

Increase use of post-acute care (at least one visit):

0-1(1%) 2-3(7%) 4-5(19%) >6(49%) •

Increase home health visits:

0-1(1%) 2-3(5%) 4-5(9%) >6(36%) •

Increase physician office visits (0/>13):

0-1(34%/4%) 2-3(7%/15%) 4-5(7%/30%) >6(8%/46%) •

Increase emergency department visits (0/>13):

0-1(86%/6(30%/27%)

670

 Chronic Condition Management Using Remote Monitoring and Telehomecare

•

Increase admissions with a re-admission within 30 days in people >65 years old:

0-1(7%) 2-3(7%) 4-5(13%) >6(24%) •

Increased per capita Medicare 2010 spending:

0-1($2,025) 2-3($5,698) 4-5($12,174) >6($32,658) Effective real time management of many CC, such as Diabetes Mellitus (DM), Hypertension (HTN), Congestive Heart Failure (CHF), and Chronic Obstructive Pulmonary Disease (COPD), requires patient self-management and behavior modification, occurs away from healthcare facilities, and depends on the regular collection of condition status data in real-life settings (remote monitoring). Measurements such as capillary blood glucose, blood pressure, respiratory peak flow rate, weight and others allow clinicians to recommend, and patients to own, behavior modifications and self-administration of prescribed medications. Electronic data capture and their Internet-enabled timely review by clinicians (remote monitoring) can enable interventional or preventative management adjustments between office visits (telehomecare). As universal Internet access approaches reality, these facts are changing the healthcare system and re-defining the roles of its players - patients, clinicians, health educators, hospitals and clinics, public health, health insurance agencies, and health care-related companies (Stachura, 2007; Singh, 2011; Mistry, 2012). It is, therefore, essential to overcome barriers to universal broadband access (Kaplan, 2003) and remove obstacles to reimbursement for multi-tiered, on-going, remote when possible, physician-led, but team-delivered, services. The resulting enhanced access to information and services should contribute importantly to strategic frameworks for the care of patients with MCC and encourage outcomes-driven, cost-effective, efficient, individual and community health while lowering the cost of healthcare systems that provide it. Nowhere are these considerations more important than in elderly populations, characterized by patients with MCC. Aging in place is, after all, the desire of most older Americans (Farber, 2011). Patients are turning from the role of passive recipients of provider instructions and interventions to more self-responsible, active and knowledgeable participants in the monitoring, decision-making, and management activities relevant both to their medical conditions and to life-style modifications that will improve and maintain health. Clinicians who were previously the custodians of health information are increasingly becoming patient and family advisers concerning the use, relevance, and individually specific applicability of generally available health information. The resulting combination of information access and clinician advice can support and empower patients for decision-making and action.

BACKGROUND Consumers are becoming active participants in all aspects of their health, including decision-making, screening, monitoring, and the behavioral change aspects of health maintenance, healthcare, CC management, and disease prevention. They live in an Internet- and wireless-linked world where they and their dependents expect access when and where they themselves perceive the need for access (Simmons, 2007). As with other commodities and services, patients seek access that maximizes their own convenience

671

 Chronic Condition Management Using Remote Monitoring and Telehomecare

rather than the convenience of the provider (Simmons, 2007) Consequently, they tend to report dissatisfaction with inefficiencies and personal inconveniences encountered in the current healthcare system: wait time for appointments, the inconvenience of physician office hours and office wait time (Higgs, 2001) and limited access to after-hours care - currently available only in emergency departments (EDs) and urgent care clinics (Afilalo, 2004) - for problems that cause patients concern but are not classified by providers as medical emergencies. Providers and businesses have begun to explore ways to provide off-hour routine and low-level urgent care (Serbaroli, 2007). Consequently, telehomecare is an increasingly recognized and valuable tool with the potential for enhancing CC care management quality while delivering new savings for both patients and providers. Patients can experience fewer office and ED visits, fewer and reduced duration of hospitalizations, reduced travel time and expense, and increased services access. Clinicians can deliver cost-effective and efficient case management, make more informed decisions, and experience enhanced patient participation and compliance (Smit, 2011). There are, however, technology, infrastructure, insurance, and reimbursement issues that must be addressed if improved care quality and cost savings are to be realized. The interrelated components of these issues will require collaborative evaluation and management by patients, payers, government, care providers, hospitals, technology companies, and employers.

Home Healthcare Eligibility for covered home health service requires that the patient be homebound. Reviewing reports concerning outcome measures and satisfaction in these individuals, Landers summarized that home health recipients had re-hospitalization rates comparable to patients residing in care facilities (Landers, 2013), were more likely to improve (Centers for Medicare & Medicaid Services. Report to Congress, 2012b), and rated the quality of home health services received as high as did patients surveyed about the quality of hospital care (Medicare Hospital Compare, 2012; Medicare Home Health Compare, 2012). In 2012, the Medicare home health benefit enabled more than 3 million patients to receive services from home health agency nurses and therapists, at a cost of more than $18 billion (Center for Medicare & Medicaid Services, 2012b). It is anticipated that more than 70 million additional Americans will become eligible for these services by 2030 (Landers, 2013).

Home Telehealth and Remote Monitoring Home Telehealth’s objective is to increase patient access to health services, improve disease management including self-care management, and drive earlier and proactive interventions for positive outcomes. Clinical need, management objectives, and available resources define required technology. Communication can be simultaneous and/or asynchronous and include video, messaging, Interactive Voice Response (IVR), and store-and-forward remote monitoring modalities such as video-conferencing, non-video reminder and surveillance questioning, and/or one or more sensors (e.g. electrocardiogram, pulse oximetry, vital signs, stethoscope, weight, glucose, and movement/position detectors). These technologies provide information about patient clinical status and support “…post-discharge care, home health, chronic care management, schools, skilled nursing facilities, sub-acute care and senior living facilities…” by providing “…education, monitoring, patient self-directed care and the ability for individuals to have more effective access to health care....” They also can be clinician enablers that “…facilitate quicker assessment and proactive intervention…to improve quality of life” (ATA, 2012). Historically, free “call-a-nurse” 672

 Chronic Condition Management Using Remote Monitoring and Telehomecare

programs have used the telephone to answer patient questions and direct them to healthcare services. Recently, the U.S. Department of Defense initiated a mobile system (mCare) to provide medication and appointment reminders and/or confirm basic patient functionality for its Warriors in Transition (TATRC, 2011). The Veterans Administration uses similar telehealth services “to target care…and improve access to care” (VA, 2011a) and provide in-home geriatric and extended care (VA, 2011b). Sophisticated telehomecare and remote monitoring activities that include data collection and monitoring of physiological parameters must be available in a mobile environment (home, work, school, and traveling) and be independent of patient and clinician location. These monitoring data will have value in many scenarios: for patient-clinician discussions at any time, for connection to an alert system that warns both patient and provider of deteriorating clinical status, and/or for immediate linkage to databases, decision-support systems, and algorithms for physician-directed mobile patient self-management.

Benefits of Home Telehealth Monitoring and Care The incorporation of home telehealth monitoring can be advantageous for informed, motivated and involved patients and families who are actively partnering with their caregivers (Greenhalgh, 2009), as well as for providers, communities, and/or the healthcare system when core parameters (access, support, education, health outcomes, quality of care, social isolation, and/or quality of life) are evaluated in the context of cost, cost-effectiveness, health services utilization, acceptability, and/or satisfaction (Ruggiero, 1999; McIntosh, 2001). •

•

• •

• •

Home telemonitoring equipment facilitates early detection of course changes, in turn enabling timely intervention by patients, families and health professionals, and the ability to monitor the success of that intervention These actions can prevent ED visits and/or hospitalizations, increasing patient and family satisfaction and security. Telemonitoring can both increase patient-home health nurse contact and decrease agency cost of providing service. Daily telephonic check-in allows data monitoring, medication compliance surveillance and question resolution while reducing agency cost because nurses visit the home only when necessary. Telemonitoring can provide family support for confidence in the role of lay caregiver, even to the point of delaying patient institutionalization. Telemonitoring can facilitate continuity of care during transitions, such as hospital-to-home, by translating in-hospital management practices into effective in-home practices. MCC patients may be taking 10 or more medications whose management is increasingly difficult in the elderly (Tinetti, 2004). Telemonitoring can improve the care of patients with severe physical or mental disabilities that make moving them for routine medical follow-up appointments difficult, costly, and even traumatic. Proper repetition of trained practices in the home can be monitored using equipment that incorporates video - post-operative rehabilitation and physical therapy success, as well as prevention, and prevention/care of decubitus ulcers, require repetition of activities or exercises.

Telehealth monitoring technologies, when employed by appropriately skilled clinicians, have the potential to improve clinical management of CC and even enhance usual care by increasing the frequency and timeliness of patient-clinician contact, without the need for increased travel. The aging population 673

 Chronic Condition Management Using Remote Monitoring and Telehomecare

provides an important example of the growing demand for efficiently delivered home health services that can be met by creative telehomecare - in 1999, 20,000 certified providers serviced approximately 8 million individuals (National Association for Home Care, 2000). However, many hospital “frequent flyers” with MCC are not homebound and are therefore ineligible for traditional home healthcare. Also, telehealth is not currently reimbursed by traditional health care payers - a fact that in itself discourages its adoption. These factors threaten the ability of traditional home health agency approaches to meet patient needs and therefore force exploration of new options (Dansky, 2001; Stachura, 2007; Singh, 2011). Adoption of home telehealth monitoring has been slow and realizable benefits underachieved. A 2009 analysis reported that almost 20% of hospitalized Medicare beneficiaries were re-hospitalized within 30 days (Jencks, 2009), prompting many hospitals to seek evidenced-based strategies to reduce readmission rates. A later report (Bradley, 2013) examined the effectiveness of ten recommended practices for heart failure patients (H2H, 2013) in a national sample of hospitals that adopted them. Among the recommendations were: (a) Have pharmacy technicians compile patients’ medication history, (b) Arrange follow-up appointments for patients before discharge, and (c) Alert patients’ primary care physicians within 48 hours of discharge. While compliance with criterion (b) rose significantly from 52.4% to 61.1%, the report cited “no significant change” regarding (c) post-discharge collaboration with the patient’s physician. (In 2010, 36.6% of hospitals had a process in place to satisfy criterion (c), that figure was only 38% in 2012). Criterion (a) compliance had changed only from 77.4% to 78%.

MULTIPLE CHRONIC CONDITIONS AND CARE TRANSITIONS Multiple chronic conditions (MCC) afflict 25% of the US population and 50% of those age 65 and older. Congestive heart failure (CHF) afflicts almost 5 million Americans, contributes to 300,000 annual deaths, and is the leading cause of hospitalization (NIH Heart & Lung Institute, 2012). Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death in the U.S.; it will cost an estimated $833 billion over the next 20 years due to an estimated 723,000 annual hospitalizations and 1.5 million annual ED visits (American Thoracic Society, 2012). Combined, CHF and COPD account for a large part of U.S. costs of care and profoundly impact patient quality of life.

Issues and Problems Whether single or multiple, we prefer the term “chronic conditions” over “chronic diseases.” Many patients seeking medical attention for a “disease” are seeking a “cure” – a medical intervention, a provider action that will rid them of the affliction and restore “health” or “well-being.” Simultaneously, individuals who are disease-free are encouraged to “maintain health.” The dictionary defines “disease” as “a disordered or abnormal state of an organism…: illness, sickness,” whereas the definition of “condition” includes the text “state of health.” Thus, a “disease” can be viewed by patients as a disorder or illness that can be “cured” through medical intervention, while a disorder termed a “condition” must be “managed” day-to-day if “health” and “well-being” are to be maintained. Care of a “disease” often requires use of hospitals and other sophisticated medical facilities, where the afflicted patient surrenders responsibility for “care” to trained professionals who “deliver” it. Managing a chronic “condition,” on the other hand, allows afflicted individuals to continue activities of life, but requires them to learn and apply self-management techniques and life-style modifications recommended by health professionals 674

 Chronic Condition Management Using Remote Monitoring and Telehomecare

who “coach” them based upon data monitored in real life settings. In a “condition,” use of hospitals or EDs represents a set-back, but is also an opportunity to restore equilibrium and re-evaluate management recommendations and life-style adjustments. Successful management of single CC or MCC requires active participation by afflicted individuals who are informed, engaged and self-responsible, and supported by families. Successful management is facilitated by patient-centered professional teams whose primary activities occur away from medical facilities. The CCs themselves are not, and should not be, the patient’s primary focus in life, but rather circumstances to be managed to interfere minimally with life. Support for afflicted individuals must, therefore, be accessible where and when needed. Accomplishing MCC management goals can be facilitated using telehealth technologies and remote monitoring. Self-Responsibility: Individuals afflicted with CC must take ownership of issues that will be present for life, have significant consequences if not managed, and are less effectively managed without active participation by health professionals. Responsibility for self-management of medication compliance, life-style modification, and accurate data measurement and reporting must be habitual, with few “vacations.” A less participatory individual, for example the elderly, is not necessarily “irresponsible” or “non-compliant,” but possibly one who requires a stronger support system. Data Gathering: Data and information for CC management resides in several locations - patient monitors, hospitals and EDs, physician offices, and home health agencies. Crucial for use of these data by patient and health professional decision-makers is that all current, relevant information be available to patient and provider at the point and time of care. Unfortunately, there is no simple way to gather and exchange this information. No existing methodology can extract necessary data from each source for use at the point/time of care because the several necessary information components are often in proprietary repositories that cannot communicate. Support Systems: Medical support systems can include gaps, such as time between hospital discharge date and first patient post-hospital provider appointment. Patients using emergency facilities for troublesome but non-emergent issues are frequently admitted to hospitals because busy EDs are ill-suited to deal efficiently with the complexities of patients with MCC. Patient care transitions between hospital, ED, physician office and home healthcare must be re-evaluated to eliminate gaps as must relationships and responsibilities of health professionals. Re-purposing professionals may be necessary to deliver tiered support based on patient need, and by the least costly appropriately trained provider. Insurance and Provider Reimbursement: Home health agencies currently are compensated by bundled 60 day payments, adjusted for patient severity, but excluding several critical expenses such as telemonitoring costs. Patients who are not “homebound” are ineligible despite the fact that home health services could achieve better outcomes at lower cost (Landers, 2013). Similar contradictions exist for non-terminal or terminal patients who would benefit from palliative services available in Hospice programs, but who are not ready to accept abandoning treatment as required for Hospice admission. Support for long-term, coordinated, tiered-to-need ambulatory care in a manner that rewards outcomes-based, effective, and efficient care may require that patient health insurance and provider reimbursement structures be reevaluated and re-calibrated. Current Medicare fee-for-service reimbursement systems create disincentives for intensive, longitudinal patient care coordination and traditional healthcare payers do not reimburse for telehealth. It is estimated that by improving management of post-acute episodes and coupling it with home health, Medicare could save $3-10 billion annually (Dobson, 2012). Further, the impact of MCC in the same patient represents more than a sum of parts: as the number of chronic conditions afflicting an individual increases, the risks of mortality, poor functional status, unnecessary hospitalizations, and 675

 Chronic Condition Management Using Remote Monitoring and Telehomecare

adverse drug interactions escalate. Care coordination and reduction of errors as well as difficulties related to care transitions can be ameliorated by using technology to make hospital, physician office, and home health data available to providers when and where providers are at the point of care.

Exploring Solutions: RightHealth™ THA Group’s on-going model care delivery project, entitled RightHealth™, incorporates remote monitoring and teleheath technologies, and is based on principles and practices required to address long term management of patients with MCC. RightHealth™’s MCC concepts are rooted Wagner’s Chronic Care Model that incorporates community, health system, self-management support, delivery system design, decision support and clinical information systems, and emphasizes activation of patients for self-management (Wagner, 1998), Coleman’s Care Transitions Model (personal health records; education about signs of chronic conditions’ exacerbation; scheduled follow up physician appointments; and medication reconciliation (Coleman, 2004), and Deming’s Total Quality Movement, where service value is defined by consumers and optimized when services or goods providers maximize quality while simultaneously minimizing the cost of access. RightHealth™ goals include: a) Improved patient outcomes that maximize patient functionality, b) Reduced costs through reduced hospital and ED use, c) Reduced delivery cost through technologyfacilitated services efficiency, and d) Improved patient/family/caregiver satisfaction. Designed as a freemarket consortium of key partners and strategic affiliates, RightHealth™ model components include traditional home health services by re-purposed home health professionals, information technology (IT) systems for chronic care management using telehealth monitoring and practices, and lead community physicians who currently are poorly connected and supported for issues of long term health care and health care transitions. Patient-centered, physician-led teams assign patient care and services delivery to less costly and scarce, appropriately trained and supervised professionals. Intrinsic to maximizing value is having the right person doing the right thing, the right way, in the right place, at the right time, the first time. RightHealth™ delivers patient-centered MCC management (right thing) by physician-led, integrated care teams (right people) empowered by health information technology (right way) at home (right place). Patients and their families are at the center of the RightHealth™ model. The patient, the patient’s physician(s) and associated team members work collaboratively to establish care plans coordinated across multiple care settings and/or care providers, creating environments characterized by boundarylessness. Interventional care aims to keep patients in the right place, their homes, through remote care that may include interactive telephony, telemonitoring, IVR, and video visits. A 24/7 Call and Triage Center ensures that care is delivered when warranted, using evidence-based practices coupled to activated patients empowered to self-manage their MCCs. In today’s Medicare paradigm, patients with MCC cycle through multiple care settings (i.e., homes, hospitals, post-acute inpatient facilities, out-patient facilities, home health and hospice) under the care of multiple physicians (primary care and specialist). Each provider is compensated on a fee-for-service basis. Medicare, however, does not reimburse for: (a) coordination of care across providers; (b) telehealth remote vital sign monitoring, in-home virtual video visits, and health coaching; (c) CC management; or (d) continuous care. Presently, in-home skilled healthcare is delivered by home health and hospice agencies. Medicare regulations stipulate that home health patients must be homebound, need skilled intermittent care and be capable of showing improvement toward established care goals. Eligible patients, as ordered by a 676

 Chronic Condition Management Using Remote Monitoring and Telehomecare

physician, receive services in 60 day episodes. Many potential patient beneficiaries of the RightHealth™ model fall outside these criteria because they are: (a) not necessarily homebound, (b) may not require skilled services; or (c) are in the final stages of their disease and unable to maintain clinical health status, but could benefit from an enhanced quality of life enabled by available services. RightHealth™ could offer these individuals required long-term, intensive management and coordination despite not meeting current Medicare criteria by providing continuous CC management by informed, activated, and self-responsible patients receiving appropriately tiered support from informed multi-level health professionals and health coaches who are seamlessly coordinated throughout care transitions. Initial patient tier assignment need not be static over time and tier movement need not be unidirectional progression from lower to higher care levels. In a successful model, patients will be expected to remain stable for prolonged periods of time, and, even if only temporarily, move to a lower tier. Whatever the tier, the goal is to reduce avoidable ED visits and hospitalizations.

RightHealth™ Evolution The RightHealth™ model’s early evolution occurred during a series of chronic care management pilot projects conducted in collaboration with local hospitals, payers and large physician groups. In 2006, South Carolina Blue Cross/Blue Shield partnered with THA Group (THA) and eight other South Carolina telemonitoring providers in a successful attempt to reduce the number of ED visits and hospitalizations for CHF beneficiaries. In 2007-2008, THA undertook a self-directed and self-funded study to demonstrate that CCs could be successfully managed by: (a) empowering individuals to own and self-manage their CCs; (b) forming a three-way partnership among physicians, patients and telehealth providers; and (c) using remote personal monitoring technology to practice telehealth. Patient eligibility criteria included at least one hospitalization in the previous six months and a diagnosis of CHF, COPD, DM, and/or HTN. Patients were not homebound and therefore ineligible for home health benefits. During the study’s first six months, patients received: (a) remote telemonitoring; (b) intensive in-home, individualized, CC-specific education; and (c) regularly scheduled telephonic visits for additional education about their CCs and self-management. If vital sign monitoring and/or patient signs and symptoms indicated a CC exacerbation, THA personnel intervened using physician pre-approved evidence-based protocols, and by conferring with the patient’s physician as indicated. The re-hospitalization rate for this group of patients was 7% at 6 months, and 23% at 12 months, in marked contrast to a similar study that did not include remote monitoring or telehealth and reported a Medicare re-hospitalization rate of 34% at 90 days and 50% at 12 months (Jenks, 2009). THA’s next pilot initiative, aimed to reduce 30 day re-hospitalization of CHF patients, began in late 2009 in partnership with Beaufort Memorial Hospital (BMH) (Beaufort SC). During model operation, re-hospitalization rates stabilized at about 10% and during several months no patient in the program was re-hospitalized within 30 days (Table 1). Collaboration between BMH and THA on CHF patients is ongoing and has resulted in BMH’s receipt of American Heart Association Performance Achievement Awards. In collaboration with Memorial University Medical Center (MUMC, Savannah GA), THA initiated two model-based pilot projects in late 2011. In the first Recidivist Study 2011 project, challenged by overuse of their ED, MUMC asked THA to work with 3 of its so-called “worst offenders.” Each patient suffered from MCC, including CHF, asthma, DM, HTN, obesity, and/or depression, and all exhibited major psychosocial challenges. The number and costs of ED visits and hospitalizations were identified and compared during three 90 day episodes: (a) pre-project; (b) project; and (c) post-project. During 677

 Chronic Condition Management Using Remote Monitoring and Telehomecare

Table 1. Reduced 30 day re-hospitalization rates at Beaufort Memorial Hospital 30 Day Re-hospitalization Quarter/Year

4Q’09

1Q’10

2Q’10

3Q’10

4Q’10

1Q’11

2Q’11

3Q’11

4Q’11

Total

Qtr. Admits

17

16

13

9

11

15

12

4

4

101

ReHosp.Admits

3

0

3

0

1

2

1

0

0

10

ReHosp %

17.6

0.0

23.1

0.0

9.1

13.3

8.3

0.0

0.0

9.9

Cum. Admits

17

33

46

55

66

81

93

98

101

101

Cum.Rehsp.Adm

3

3

6

6

7

9

10

10

10

10

Cum.ReHosp%

17.6

9.1

13.0

10.9

10.6

11.1

10.8

10.3

9.9

100

the 90 day “project” episode, THA successfully reduced ED usage and hospitalization when compared with either the pre- or post-project episodes. In the 90 days post-discharge from the program, patients’ use of both emergent and acute care again increased (Table 2). The second 2011 project targeted ten CHF Medicare beneficiaries who received care, including care transition and CHF-related protocols, following hospitalization at MUMC. Table 3 compares costs of ED use and re-hospitalization care for three 90 day episodes: (a) preceding admission to the project; (b) during project enrollment; and (c) following discharge from the project. Current THA/ RightHealth™ explorations include (a) evaluating the value of adding interactive video to standard remote monitoring suites in CHF and COPD, (b) developing with industry provider- and patient-specific dashboards that display current patient status data for patient/provider use at the point/ time of contact, for patient(self) and/or provider status surveillance monitoring, and (c) partnering with various value-centric organizations - Accountable Care Organizations, Patient Centered Medical Homes, Community Hospitals - to integrate acute care across hospital, office and residence settings. Table 2. THA group reduced frequent-user ED cost at Memorial University Medical Center 270 Day ED Recidivist Study (average costs) 90 Day Phase

Patients/Phase

Average Cost

Average Cost (excludes 1 patient)

Pre-CCMM

3

$37,156.65

$33,778.20

During CCMM

3

$5,865.96

$6,678.09

Post-CCMM

2

$35,389.00

Not available

Table 3. THA group reduced cost of ED use and re-hospitalization in CHF Medicare Beneficiaries 270 Day CHF Study (Average of all costs for all patients) 90 Day Phase

Patients / Phase (excludes 1 Outlier)

Patients / Phase

Average per Patient Cost

Ave per Pt Cost (excludes 1 outlier)

Pre-Project

10

9

$36,510.75

$35,203.41

During Project

10

9

$18,470.81

$9,919.67

Post-Project

3

3

$26,135.13

(Data pending)

678

 Chronic Condition Management Using Remote Monitoring and Telehomecare

FUTURE RESEARCH DIRECTIONS The original goal of “telemedicine” was to connect patients to clinical expertise not available in more rural communities. The potential for telehomecare and remote monitoring was recognized early, but its practical application required advances in telecommunication and remote sensor technologies. Many recognized that tele-activities for CC monitoring and management would dwarf tele-consultative activities, based upon (a) reduced total cost of equipment and maintenance, (b) growth of participating healthcare professions, (c) growth of informatics systems required to collect and stratify transmitted clinical data, and (d) increased personnel to interpret data and communicate with providers or intervene directly using physician-pre-approved protocols. The shared hypothesis is that increased long-term patient monitoring and management intensity will create (a) improved patient health with (b) resultant reduction of acute and chronic complications which translate directly into (c) decreased utilization of ED and hospital resources, as well as (d) decreased long term disease complications (Hersh, 2002; Aoki, 2003; Herbert, 2006). Sensor technologies: Interest in the tools of remote monitoring is growing rapidly. Any catalog of innovations will quickly be obsolete. In general, however, remote sensors fall into two broad categories: (a) consumer-targeted monitoring for wellness, and (b) medically-oriented monitors targeting illnessor condition-specific physiologic parameters. The former are more generally applicable to individual self-assessment of wellness – heart rate, calories burned during exercise, distance travelled, restlessness during sleep, weight gain/loss. The latter are more sophisticated, clinical condition-targeted, collectors of data that confirm clinical stability and response to therapy, warn of deterioration requiring intervention, and facilitate provider decision-making concerning management plan modification needs. The original clinical technologies measured patient vital signs – blood pressure, heart rate, weight – and basic physiologic measurements – capillary blood glucose, peak expiratory flow rate. Disease prevalence has driven development of specific solutions for specific needs – sleep apnea monitors, continuous electrocardiography, microbiochemistry tests, risk of pressure ulcer, urine output in mobile para-/ quadriplegics, and, for the homebound when visual inspection is informative, incorporating video capability. Enhanced monitors include disease-specific branching logic for more refined analytics and use continuous biometric monitoring for predictive analysis. More sophisticated remote biometric monitors incorporate interactive management assessment software and establish residence occupant patterns (passage through doors and lighting or appliance use) to recognize deviation from usual behavior patterns and falls. Communications Infrastructure: The core communication requirement for effective real time remote monitoring is inexpensive mobile access to the Internet using universally available broadband. This remains a challenge in many rural and most remote areas where progress is hampered by the cost of extending service to consumers whose numbers decrease with increasing remoteness. Interoperability and Integration: While remote monitoring generates enormous quantities of raw clinical data, what patients and clinician decision-makers need is relevant synthesized and actionable information. This information must be capable of incorporation into, and extraction from, electronic medical records (EMR) now required for hospitals and physicians. Current proprietary EMRs often make it difficult or impossible to share clinical data in a timely manner. Reimbursement: Reimbursement for remote monitoring and the evaluation of remote monitoring data does not currently exist for physicians or for the home health personnel who are uniquely positioned to recognize, act upon, and coordinate the management of real time patient problems using changes in remote monitoring data. New healthcare reimbursement models will be required to realize the full benefit of remote monitoring. 679

 Chronic Condition Management Using Remote Monitoring and Telehomecare

Thus, in addition to the development of new technologies, the critical issue for future research will be the business case for remote monitoring. Considering the various elements of the existing healthcare system (patient, provider, infrastructure, payor, community, state, nation), the sector benefiting clinically and financially from remote monitoring and tele-healthcare services is frequently not the sector responsible for the financial burden of providing and maintaining the infrastructure required to make those services available. Further, the sector responsible for the financial burden of providing the short term monitoring and management services aimed at reducing long term complications may not be, or may not perceive itself to be, the sector that benefits financially from the prevention of long term complications of chronic disease. These questions are critical to how we will pay for telehomecare and remote monitoring. Telehomecare and remote monitoring, as well as access to health-related information on the Internet will evolve the business of healthcare in the direction of the consumer, and that evolution will require re-examination of the business and reimburesment model of healthcare and its services. “The expectation is that once patients more directly pay for their health expenses, they are more likely to be cost and health conscious and demand better service” (Simmons, 2007).

CONCLUSION The core paradigm associated with telehomecare and remote monitoring is that CC management is consumer-centric. Providers remain the source of CC care plans but delivery is by the patient and will require an added and time consuming provider function – that of real-time advisor. Real-time or bundled data uploaded to databases to which both patient and provider have access will require review, interpretation, and may require action. Because patients will want to minimize the effect of their CCs on productivity, they will want to minimize any disruption the condition might cause. Patients will use monitoring data to make CC management decisions on-the-go. Real time questions will arise. Patients and families will want answers sooner rather than later, and at times and locations convenient for them. In other words, they will want a new and more flexible level of access to their providers (Simmons, 2007). Providers will want systems that monitor in-coming data automatically, recording and filing normal results but bringing out-of-target-range data to their attention – even automatically providing cautionary messages to patients. The data may signal need for intervention - preventative change in management, follow-up call of further inquiry, or need for in-person appointments. The real time patient benefits are clear, as are the healthcare system savings that will result from reducing the development of complications and use of expensive acute care resources by CC patients, even though delivering remote monitoring services and follow-up will have their own costs. In-home telemonitoring can enable more sophisticated delivery of home care services, detect and alert about patient status deterioration early in problem development, and minimize the need for complicated and cumbersome patient transportation to hospital/office appointments. Because they can now be reliably monitored at home, home-bound patients may actually be able to receive better care. When the homecare program is carefully designed and implemented, release from the hospital will not endanger patient health or increase re-hospitalization, will reduce patient exposure to hospital-acquired infections, and will minimize risks associated with return to the hospital/office for routine clinical examinations (Ruggiero, 1999; McIntosh, 2001; Morlion, 2002). In summary,

680

 Chronic Condition Management Using Remote Monitoring and Telehomecare

• • • • •

Remote monitoring and telehealth technologies are essential components of effective CC management. Data from remote monitoring risk will overwhelm clinicians and contribute to inefficiency unless processed to present only relevant information. Current and information from wherever CCs are managed – home, clinical office, ED, hospital – should be available to clinician providers at the point/time of care. Patient-centered, physician-led care teams should be structured to deliver care and ensure smooth care transitions using the least costly appropriately skilled team member. Proper team function may require re-purposing of roles, responsibilities, and relationships. Cost-effective long-term delivery of outcomes-driven CC and MCC care at the point/time of care (including end-of-life care) by appropriately compensated health professionals and care delivery entities will require that citizens, health professionals, health professional organizations, hospitals and hospital systems, insurers, government, employers, health-related industries and ethicists collaborate to re-evaluate and adjust the system of care to make it effective, fair, and sustainable.

REFERENCES H2H (H2H Quality Improvement Initiative). Retrieved October 18, 2013, from http://www.h2hquality.org/. Afilalo, J., Marinovich, A., Afilalo, M., Colacone, A., Leger, R., Unger, B., & Giguere, C. (2004). Nonurgent emergency department patient characteristics and barriers to primary care. Academic Emergency Medicine, 11(12), 1302–1310. doi:10.1111/j.1553-2712.2004.tb01918.x PMID:15576521 American Telemedicine Association, & the Home Health and Remote Monitoring Special Interest Group. Retrieved January 15, 2014, from http://www.americantelemed.org/get-involved/ata-member-groups/ special-interest-groups/home-telehealth-remote-monitoring American Thoracic Society. Retrieved January 27, 2014, from http://www.thoracic.org/. Aoki, N., Dunn, K., Johnson-Throop, K. A., & Turley, J. P. (2003). Outcomes and methods in telemedicine evaluation. Tmed J and E Health, 9(4), 393–401. PMID:14980098 Bradley, E. H., Sipsma, H., Horwitz, L. I., Curry, L., & Krumholz, H. M. Contemporary Data about Hospital Strategies to Reduce Unplanned Readmissions – What has Changed? Retrieved November 4, 2013, from http://archinte.jamanetwork.com/article.aspx?articleid=1754989. Center for Medicare & Medicaid Services. (2012a). Chronic Conditions Among Medicare Beneficiaries, Chartbook: 2012 Edition. Center for Medicare & Medicaid Services. (2012b) Report to Congress: Post Acute Care Payment Reform Demonstration. Retrieved November 7, 2013, from http://www.cms.gov/Reports/Downloads/ Flood_PACPRD-RTC_CMS_Report_Jan_2012.pdf. Center for Medicare & Medicaid Services. (2013). Home health prospective payment system rate update for CY2014. Washington, DC: Center for Medicare & Medicaid Services.

681

 Chronic Condition Management Using Remote Monitoring and Telehomecare

Coleman, E. A., Min, S., Chomiak, A., & Kramer, A. M. (2004). Post-hospital care transitions: patterns, complications, and risk identification. Health Services Research, 39, 1449–1465. doi:10.1111/j.14756773.2004.00298.x PMID:15333117 Dansky, K. H., Palmer, L., Shea, D., & Bowles, K. H. (2001). Cost analysis of telehomecare. Telemedicine Journal and e-Health, 7(3), 225–232. doi:10.1089/153056201316970920 PMID:11564358 Department of Health and Human Services Office of Inspector General. (2012). Inappropriate and Questionable Billing by Medicare Home Health Agencies. Retrieved November 7, 2013, from https:// oig.hhs.gov/oei/reports/oei-04-11-00240.pdf. Dobson, A., DaVanzo, J., El-Gamil, A., Heath, S., & Shimer, M. Berger, G., Pick, A., Manolov, N., & Freeman, J.M. (2012). Clinically Appropriate and Cost Effective Placement (CACEPP): Improving Health Care Quality and Efficiency. Alliance for Home Health Quality and Innovation, Washington, DC. Farber, N., & Shinkle, D. (2011). Aging in Place: A State Survey of Livability Policies and Practices. Washington, DC: AARP Public Policy Institute. Greenhalgh, T. (2009). Chronic illness: beyond the expert patient. BMJ (Clinical Research Ed.), 338, 629–631. doi:10.1136/bmj.b49 PMID:19223339 Heart, N. I. H., & the Lung and Blood Institute. Retrieved January 27 2012, from http://www.nhlbi.nih. gov/. Herbert, M. A., Korabek, B., & Scott, R. E. (2006). Moving research into practice: A Decision Framework for Integrating Home Telehealth into Chronic Illness Care. International Journal of Medical Informatics, 75, 786–794. doi:10.1016/j.ijmedinf.2006.05.041 PMID:16872892 Hersh, W., Helfand, M., Wallace, J., Kraemer, D., Patterson, P., Shapiro, S., & Greenlick, M. (2002). A systematic review of the efficacy of telemedicine for making diagnostic and management decisions. Journal of Telemedicine and Telecare, 8, 107–209. doi:10.1258/135763302320272167 PMID:11972946 Higgs, Z. R., Bayne, T., & Murphy, D. (2001). Healthcare access: A consumer perspective. Public Health Nursing (Boston, Mass.), 18(1), 3–12. doi:10.1046/j.1525-1446.2001.00003.x PMID:11251867 Hwang, W., Weller, W., Ireys, H., & Anderson, G. Out-of-pocket medical spending for care of chronic conditions. Health Affairs, 20, 267–278. doi:10.1377/hlthaff.20.6.267 PMID:11816667 Jencks, S. F., Williams, M. V., & Coleman, E. A. (2009). Rehospitalizations among patients in the Medicare fee-for-service program. The New England Journal of Medicine, 360(14), 1418–1428. doi:10.1056/ NEJMsa0803563 PMID:19339721 Kaplan, D. (2003). Broadband: A Vital Communications Link for People with Disabilities. Retrieved January 15, 2014, from http://www.wid.org/publications/broadband-a-vital-communications-link-forpeople-with-disabilities Landers, S. (2013). The Future of the Medicare Home Health Program. Journal of the American Medical Association, 310(14), 1443–1444. doi:10.1001/jama.2013.278062 PMID:24137758

682

 Chronic Condition Management Using Remote Monitoring and Telehomecare

McIntosh, A., & Thie, J. (2001). The development of a new model for community telemedicine services. Journal of Telemedicine and Telecare, 7(Suppl. 1), 69–72. doi:10.1258/1357633011936796 PMID:11576499 Medicare Home Health Compare. (2013). Retrieved November 7, 2013, from http://www.medicare.gov/ homeheathcompare/.2012. Medicare Hospital Compare. (2012). Retrieved November 7, 2013, from http://www.hospitalcompare. hhs.gov/.2012. Mistry, H. (2012). Systematic review of studies of the cost-effectiveness of telemedicine and telecare. Changes in the economic evidence over twenty years. Journal of Telemedicine and Telecare, 18(1), 1–6. doi:10.1258/jtt.2011.110505 PMID:22101609 Morlion, B., Knoop, C., Paiva, M., & Estenne, M. (2002). Internet-based home monitoring of pulmonary function after lung transplantation. American Journal of Respiratory and Critical Care Medicine, 165, 694–697. doi:10.1164/ajrccm.165.5.2107059 PMID:11874816 NAHC (National Association for Home Care). (2000). Basic statistics about home care. Retrieved June 6, 2013, from http://www.nahc.org/Consumer/hcstats.html. Ruggiero, C., Sacile, R., & Giacomini, M. (1999). Home telecare. Journal of Telemedicine and Telecare, 5, 11–17. doi:10.1258/1357633991932333 PMID:10505364 Serbaroli, F. J. (2007). Legal guidelines for operators of “walk-in” clinics. New York Law Journal, 237(61). Simmons, S. C., Kragel, P. J., & Jones, G. L. (2007). Perspectives on Consumer Telehealth. In Proceedings of the 3rd IASTED International Conference on Telehealth, Montreal (pp. 72-76). Quebec, Canada. Singh, R., Matthiassen, L., Stachura, M. E., & Astapova, E. V. (2011). Dynamic Capabilities in Home Health: IT-Enabled Transformation of Post-Acute Care. Journal of the Association for Information Systems, 12(Special Issue), 163–188. Smit, F., Lokkerbol, J., Riper, H., Majo, M. C., Boon, B., & Blankers, C. (2011). Modeling the costeffectiveness of health care systems for alcohol use disorders: How implementation of eHealth interventions improves cost-effectivness. Journal of Medical Internet Research, 13(3), e56. doi:10.2196/ jmir.1694 PMID:21840836 Stachura, M. E., & Khasanshina, E. V. (2007). Telehomecare and Remote Monitoring: An Outcomes Overview. White Paper available from The Advanced Medical Technology Association. Washington DC or from the authors. TATRC (Telemedicine and Advanced Technology Research Center). Retrieved October 21, 2013, from http://www.tatrc.org/locs_south_events.html. Tinetti, M. E., Bogardus, S. T., & Agostini, J. V. (2004). Potential pitfalls of disease-specific guidelines for patients with multiple conditions. The New England Journal of Medicine, 351(27), 2870–2874. doi:10.1056/NEJMsb042458 PMID:15625341

683

 Chronic Condition Management Using Remote Monitoring and Telehomecare

Veterans Administration. (2011a). Retrieved November 5, 2013, from http://www.va.gov/geriatrics/ Guide/LongTermCare/Telehealth_Care.asp. Veterans Administration. (2011b). Retrieved November 5, 2013, from http://www.telehealth.va.gov/ccht/. Wagner, E. (1998). Chronic disease management: What will it take to improve care for chronic illness? Effective Clinical Practice, 1, 2–4. PMID:10345255

ADDITIONAL READING Agha, Z., Dunn, K., Fukui, T., Beck, J. R., Schull, W. J., & Li, H. K. (2002). Cost-effectiveness of telemedicine for the delivery of outpatient pulmonary care to a rural population. Telemedicine Journal and e-Health, 8(3), 281–291. doi:10.1089/15305620260353171 PMID:12419022 Bolch, E. B., Stachura, M. E., Astapova, E. V., & Rosengart, C. L. (2010). Redesigning the Home Care Management Model: Return on Investment. Fifteenth Annual International Meeting and Exposition of the American Telemedicine Association, San Antonio, TX. Cleland, J. G., Louis, A. A., Rigby, A. S., Janssens, U., & Balk, A. H. (2005). Noninvasive Home Telemonitoring for Patients with Heart Failure at High Risk of Recurrent Admission and Death. Journal of the American College of Cardiology, 45(10), 1654–1664. doi:10.1016/j.jacc.2005.01.050 PMID:15893183 Cox, R., Wichman, G., Gilson, P., Bannister, T., Walker, M., & Zollinger, B. (2004). Monitoring chronic disease in the home: clinical and financial observations. Telemedicine Journal and e-Health, 10(1), S-32. Craft, A. (2004). Out of hours care. Archives of Disease in Childhood, 89(2), 112–113. doi:10.1136/ adc.2003.040642 PMID:14736617 Gilmer, T. P., O’Connor, P. J., Manning, W. J., & Rush, W. A. (1997). The cost to health plans of poor glycemic control. Diabetes Care, 20, 1847–1855. doi:10.2337/diacare.20.12.1847 PMID:9405905 Goldberg, L. R., Piette, J. D., Walsh, M. N., Frank, T. A., Jaski, B. E., Smith, A. L., & ... (2003). Randomized trial of a daily electronic home monitoring system in patients with advanced heart failure; the Weight Monitoring in Heart Failure (WHARF) trial. American Heart Journal, 146, 705–712. doi:10.1016/ S0002-8703(03)00393-4 PMID:14564327 Jennett, P. A., Hall, L. A., Hailey, D., Ohinmaa, A., Anderson, C., Thomas, R., & ... (2003). The socioeconomic impact of telehealth: A systematic review. Journal of Telemedicine and Telecare, 9(6), 311–320. doi:10.1258/135763303771005207 PMID:14680514 Kinsella, A., Telehealth Opportunities for Home Care Patients. (2003). Home Healthcare Nurse, 21(10),661-665. doi:10.1097/00004045-200310000-00004 PMID:14557704 Magid, D. J., & Green, B. B. (2013). Home Blood Pressure Monitoring: Take it to the Bank. Journal of the American Medical Association, 310(1), 40–41. doi:10.1001/jama.2013.6550 PMID:23821085

684

 Chronic Condition Management Using Remote Monitoring and Telehomecare

Maiolo, C., Mahamed, E. I., Fiorani, C. M., & DeLorenzo, A. (2003). Home telemonitoring for patients with severe respiratory illness: the Italian experience. Journal of Telemedicine and Telecare, 9, 67–71. doi:10.1258/135763303321327902 PMID:12699574 Paré, G., Jaana, M., & Sicotte, C. (2007). Systematic Review of Home Telemonitoring for Chronic Diseases: The Evidence Base. Journal of the American Medical Informatics Association, 1, 269–277. doi:10.1197/jamia.M2270 PMID:17329725 U.S. Department of Health & Human Services (2010). Multiple Chronic Conditions: A Strategic Framework. Optimum Health and Quality of Life for Individuals with Multiple Chronic Conditions. December 2010,1-16. Warshaw, G. (2006). Introduction: advances and challenges in the care of older people with chronic illness. Generation, 30(3), 5–10. Whitten, P. S., Mair, F. S., Haycox, A., May, C. R., Williams, T. L., & Hellmich, S. (2002). Systematic review of cost effectiveness studies of telemedicine interventions. BMJ (Clinical Research Ed.), 234, 1434–1437. doi:10.1136/bmj.324.7351.1434 PMID:12065269 Wolff, J. L., Starfield, B., & Anderson, G. (2002). Prevalence, Expenditures, and Complications of Multiple Chronic Conditions in the Elderly. Archives of Internal Medicine, 162(20), 2269–2276. doi:10.1001/ archinte.162.20.2269 PMID:12418941 Wolosin, R. J. (2005). The voice of the patient: A national representative study of satisfaction with family physicians. Quality Management in Health Care, 14(3), 155–164. doi:10.1097/00019514-20050700000004 PMID:16027593

KEY TERMS AND DEFINITIONS Chronic Condition/Disease: A chronic condition/disease lasts one year or more, limits activities of daily living, and/or requires on-going medical attention. It can be controlled, but not cured. While chronic diseases/conditions are often preventable, and most can be effectively managed, they are among the health care system’s most costly health problems. Covered Home Health Services: Home health services prescribed by a physician who helps the home health care agency set up a care plan for patients who require part-time skilled nursing care or physical, speech, or occupational therapy. Care must be provided by a Medicare-approved agency to patients confined to home because of injury, illness, or other medical condition, in order to maintain the condition slow its deterioration. Electronic Medical Record: An EMR is a digital version of a paper medical chart in a medical office, a hospital, or a medical enterprise that contains the medical and treatment history of the patients managed in that setting. It allows patient care information and data to be stored, tracked, and retrieved over time. Information Technology: Anything related to computing technology, such as networking, hardware, software, the Internet, or the people that work with these technologies. In healthcare, it is the supporting infrastructure, software, and methodologies by which information is gathered, processed and analyzed in order to create new information for clinical decision support.

685

 Chronic Condition Management Using Remote Monitoring and Telehomecare

Multiple Chronic Conditions: MCC is defined by the National Quality Forum’s Draft Report on Multiple chronic conditions Measurement Framework as “…two or more concurrent chronic conditions that collectively have an adverse effect on health status, function, or quality of life and that require complex healthcare management, decision-making, or coordination.” MCC afflict about 25% of the US population and about 50% of those 65 years of age and older. Remote Monitoring: Uses technology to enable real time evaluation of patient clinical status by patients themselves and their clinical providers, outside conventional clinical settings (home, work, school, travel). Ideally, it uses wireless technologies to function in mobile environments. It enables patient selfmanagement and timely clinician interventional and/or preventative management. Telehealth: The delivery of health-related services and information using telecommunications technologies. Telehealth includes education, medication management, health and wellness promotion, and health management, especially in chronic diseases where home monitoring of physiologic parameters can detect changes in patient status in order to facilitate timely correctional and/or preventative interventions. Telehomecare: The home delivery of healthcare services to patients using telecommunications technologies that capture patient clinical status measurements to enable and facilitate timely education, information dissemination, social, emotional and self-care support, as well care management by a healthcare professional at an external site or unscheduled home visits based on need. Messaging, voice, and/or video technologies may be employed. Telemedicine: The use of telecommunication technology to move data in order to facilitate healthand healthcare-related education, care, diagnosis, mentoring, management and research over distance. As defined by the American Telemedicine Association: “…the use of medical information exchanged from one site to another via electronic communications to improve a patient’s clinical health status. Telemedicine includes a growing variety of applications and services using two-way video, email, smart phones, wireless tools and other forms of telecommunications technology.”

This research was previously published in the Encyclopedia of Information Science and Technology, Third Edition edited by Mehdi Khosrow-Pour, D.B.A., pages 3318-3331, copyright year 2015 by Information Science Reference (an imprint of IGI Global).

686

687

Chapter 34

Towards a Telehomecare in Algeria: Case of Diabetes Measurement and Remote Monitoring Karim Zarour University Constantine 2, Algeria

ABSTRACT Most developing countries are generally characterized by some problems such as limited resources and professional isolation in the health area. Information and Communication Technology (ICT) is supposed to give solutions through the use of e-Healthcare technologies. Information and communication technologies are valuable tools used to establish and maintain connections within and between healthcare providers, and between healthcare providers and Patients. Telehomecare evolves constantly. It can aid disabled persons, increase patient compliance, enhance caregivers’ effectiveness, and connect socially isolated individuals to their care providers. Various research works have investigated different aspects of ICT in the context of telehomecare in some developed and developing countries. This paper describes an architectural framework for the development of telehomecare in Algeria for diabetes measurement and remote monitoring.

INTRODUCTION Information and Communication Technologies (ICT) are important in facilitating communication and sharing information among stakeholders for telemedicine and especially for TeleHomeCare (THC). Telemedicine in homecare, or telehomecare, uses modern technologies to enable the communication and the transfer of information between the health care provider at the clinical site and the patient at his/ her home. In THC, the patients conduct their interactions with their health care providers in their own homes. Telehomecare is an emerging field that will benefit homecare providers and their patients. It does not replace in home care visits, but is used primarily to augment current services. Most countries DOI: 10.4018/978-1-5225-7122-3.ch034

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Towards a Telehomecare in Algeria

are now facing an urgent requirement to provide appropriate retired home environment solutions for patients and allow them to stay at their own homes. Partial solutions for specific case studies of THC system are described in (Nourizadeh, 2001). According to (Koch, 2006) most developed countries are facing important overall problems regarding healthcare services, such as: (i) increased demand of healthcare due to an increased number of elderly and changed life styles leading to an increase in chronic diseases (ii) demand for increased accessibility of care outside hospitals, moving health services into the patient’s own homes (iii) need for increased efficiency, individualization and equity of quality-oriented healthcare with limited financial resources (iv) difficulties of recruiting and retaining personnel in the healthcare services in general and in home and elderly care in particular. At the same time, there are several problems in homecare service in Algeria, such as: (i) current solutions based on manual note taking are slow (ii) obstacle to real-time data access (iii) medical staff is not up to date on the state of the patient (that curbs the ability of clinical diagnostics and monitoring) (iv) slow and laborious process of homecare (v) time consuming (vi) traditional data storage mode is not conducive to the sharing of resources. Therefore, there cannot be information sharing among all the stakeholders. In Algeria, health-care in most remote rural areas is provided by simple clinics staffed by nurses, perhaps with an assistant. There is a serious shortage of medical specialists such as doctors and nurses in such areas. Patients cannot see a doctor or visit a hospital whenever necessary. Besides the infrastructure for health research in Algeria resides generally in the public sector. Telehomecare in Algeria is still facing many challenges especially in rural areas such as (Zarour, 2015): • • • • •

Unavailability of the required ICT infrastructure for THC (e.g. internet connection) High cost of THC solutions. Lack of patients’ awareness and acceptance of receiving healthcare services via THC networks and applications. Lack of uniform standards for data-sharing: Unified format and content of data storage are the basis for communication between systems. Information classification and data standards are not strictly uniform. Security, safety and privacy of data exchange.

In this paper, we propose a global architecture for THC, adapted to the concrete needs of the homecare in Algeria with a case study of diabetic persons. This architecture allows the sharing, the fast and supple exchange of information, and opens new perspectives of THC in Algeria. Besides helping in saving costs, encouraging the treatment of patients at their homes may also reduce loneliness and the stress they suffer during a hospital stay. An important point is to overcome the problem of the unavailability or lack of health personnel. The remainder of this paper is organized as follows. Background and related work is detailed in Section 2, followed by the architecture of the proposed system in Section 3. Public cloud supporting THC is detailed in section 4 and communication and tools in section 5. The prototype implementation is described in section 6 and discussion and evaluation in section 7. Finally, a conclusion with a view to the future is given in Section 8.

688

 Towards a Telehomecare in Algeria

BACKGROUND AND RELATED WORK Telehomecare Telehomecare uses ICT to deliver patient care to the home. It is an emerging field that will benefit home care providers and their patients. It does not replace in home care visits, but is used primarily to augment current services. Examples of THC are: monitoring a patient’s wound care progress, monitoring a newly diagnosed Diabetic patient’s blood sugars, monitoring a chronic heart failure patient for fluid overload with recording of daily weights. The goal is to inspire individuals to manage their own health at home. According to the literature, several definitions are attributed to the THC. In the work of (Stachura, 2007), THC is the use of technology to deliver patient care in the home or place of residence, providing patient-provider contact without either having to travel. In our context, we take consideration this definition. According to (Tambo, 2010), THC is a specialisation of telemedicine where the patient with or without support from family or local care do herself manage in monitoring and treatment under electronic observation from qualified clinical staff. Telehomecare is a subfield within telehealth. It involves the delivery of healthcare services to patients at home through the use of telecommunications technologies, which enable the interaction of voice, video, and health-related data explain (Bowles & Baugh, 2007). The author of (Demiris, 2004) uses the concept of home based eHealth to include both THC and smart homes. Generally, users who can benefit from THC are (Chan, 2009): • • • • • •

People living alone who are unable to seek help in emergencies (unconsciousness, falls, strokes, myocardial infarction, etc.) Elderly or disabled people who suffer from cognitive (e.g. Alzheimer) and/or physical (visual, hearing, mobility, etc.) impairment People who need help in daily life to perform personal care activities (e.g. toileting) and instrumental activities (cooking healthy meals, dealing with medication, and doing laundry) People living in rural and remote communities or in urban communities with inadequate health service provision People who suffer from chronic disease, and who need continuous monitoring (e.g. diabetes) People involved in telehealth care undertaking health care at a distance or telemedicine, with physicians practising ‘virtual visits’

Hospital Hospitals need information technology to help them ensure that medical information is accurate and to improve communications among doctors, nurses and patients. Hospital Information Systems are characterized by their ability to record and transmit information and medical knowledge. The objectives of this information are various; in particular they include patient care, quality assessment, research, epidemiology, planning, management and training. Electronic Medical Record (EMR) is the main hospital database to store all in- and out-patient’s medical records. The nature of the information exchanged is wide; they depend on the actor and their field of activity and the action taken. We classify it into three categories:

689

 Towards a Telehomecare in Algeria

• • •

Medical: related medical information. Organizational: activities of all actors Common: hierarchical roles and functions among all actors.

Hospitals can be characterized by their functions, their types of processed information and their types of services. Hospital provides many health care services. Among these services we find homecare. In Algeria, few hospitals provide this service. Indeed, this service is only based on either the psychological treatment or on the control patient with chronic disease. This control is done by the patient himself at home. It is the case for diabetic persons. The patient records all actions taken manually on paper and delivers them to the doctor or nurse when a consultation in hospital is required. However, we recall that homecare is beginning to be known thanks to sensitization of the health professional and the patient himself who he is the center of this service. Advanced technologies such as informatics and remote controls have enhanced the services of the hospital and distance has become meaningless. It is the case for hospitals in Algeria which THC and remote monitoring are necessary.

Mobile Health Care The development of smartphones is useful for mobile-Health system, which allows mobile medical professionals to attend to patients remotely. Indeed, the Development of mobile applications is particularly draw great interest to the healthcare community such as home healthcare or health monitoring for patients. In this context, we mention some works. The author of (Koufi, 2013) presents a prototype PHR-based system that aims at supporting chronic disease management at any point of care or decision making through familiar environments such as Google’s Android. In particular, it assists healthcare professionals in assessing an individual’s condition and in forming the appropriate treatment plan for him/ her while it provides individuals with step-to-step guidance to their treatment plans. In order to increase usability of the system proposed in this work, Android applications have been developed to manage accurate and relevant personal data as well as the relevant treatment plans in a timely manner in a private and secure environment. The proposed system in (Smith & Sankaranarayanan, 2012) allows the appointment with a particular doctor in the hospital after verifying his license to avoid approaching fake doctors. Finally, the system also alerts the hospital authorities for poor rating/popularity enabling improvement. The authors have developed a smart agent based system towards searching of hospitals in a particular location. The system uses Android, JADE-LEAP and the Google API to provide solution. An Android mobile-based system for collection and targeted distribution of the latest alerts and realtime environmental factors to the Malaysian population is proposed by (Chung, 2014). This mobile system is designed to facilitate and encourage research into environmental health quality issues by providing a comprehensive tracking and monitoring tool correlated to social media networks. This system is embedded with Google Maps and Geocoding services to visualize the location and environmental health reports from the aggregated social media news feeds; the output is also shared across the social media networks. The mobile devices are being promoted as a technology that can play a vital role in health domain. Although, sometimes, their use may not produce the expected results. In this context, according to the experience of (Braa & Nielsen, 2013) in mobile health projects, that in practice realizing of such projects tends to be difficult owing to a number of socio-technical challenges.

690

 Towards a Telehomecare in Algeria

Agent in E-Healthcare The agent technology is used to enhance the patient’s needs which include availability, speedy response time, and efficiency. Agent for e-Healthcare creates connectivity on an anytime-anywhere-any-devicebasis to provide the specific service from the doctor required by the patients (Subalakshmi, 2011). Moreover, Fox identified other benefits of agents applied to healthcare (Fox, 203): (a) agent technology offers advanced platforms for building expert systems to assist individual clinicians in their work and (b) distributed agent systems have the potential to improve the operation of healthcare organizations, where failures of communication and coordination are important sources of error. The work of (Bergenti, & Poggi, 2009) describes the main reasons why multiagent systems are considered one of the most interesting technologies for the development of healthcare applications and services. First, it provides some guidelines intended to help identifying the kinds of healthcare applications that can truly take advantage of the features of multi-agent systems. Then, it presents some of the most important international projects that used multiagent systems in the healthcare domain. Isern in their work (Isern, 2010)) determined the fields of application of agents in healthcare. They identified several categories or subdomains of applications summarized as follow: medical data management, decision support systems, planning and resource allocation, composite systems and remote care (i.e. approaches aimed to remotely monitor the status of patients allowing pervasive care).

RELATED WORK In Algeria There is a few or lack of telehomecare projects in Algeria. The problem is accentuated by a lack of infrastructure and health personnel. Supported by the WHO (World Health Organization) a tele-learning project was finalized by the ANS (Blood National Agency) in collaboration with the ANDS (National Agency for Healthcare Documentation). It is intended for distance education in the fields of immuno-hematology and serology for testing of blood for isolated areas of Country. This first experience was launched on March 2002 (SanteDZ, 2002). According to experts of CDTA (Development Center of Advanced Technologies), the telemedicine project dates from 2007. Several experiments have been conducted since November 2007 (Hocini et al., 2008). A prototype of the project Telemedicine Network Algeria (DZ-RT), connecting the University Hospital Centre (CHU) Lamine Debaghine Bab El Oued (Algiers) and public hospital establishments (EPH) wilaya of Bechar Laghouat and was launched in 2010. This project is part of the partnership agreement between the Ministry of Health, Population and Hospital Reform and the Post Office and Information technology and communication. It is managed by the National Agency of technology parks (ANPT) and the National Agency for Healthcare Documentation (ANDS). According to (SanteDZ, 2002), the platform-Health- Algeria is set up in order to host the project of: Tele-assistance in care (diagnostic assistance, assistance in the interpretation of medical investigations, assistance in therapeutic) aimed accessibility to quality care for all patients, particularly those living in isolated areas to overcome the lack of specialists. Tele-education in the context of medical and paramedical initial training and continuing education of health personnel and other stakeholders in public health

691

 Towards a Telehomecare in Algeria

As part of the twinning between the University Hospital of Bab-El-Oued and the Assistance Public Hospitals of Marseille, the National Agency for Healthcare Documentation (ANDS) was selected to manage the actions of the first operation of tele-assistance and tele-education in radiology between the two institutions in February 2012. The EMISPHER project (Euro-Mediteranean Internet-Satellite Platform for Health, Medical Education and Research) is launched in partnership between the European Union EUMEDIS (EUro-MEDiterranean Information Society), and the National Agency for Healthcare Documentation (ANDS). This project includes tele-consultation, tele-education, medical training and tele-assistance. According to the General Direction of Scientific Research and Technological Development (DGRSDT) a telemedicine system will be implemented in all national hospitals. This project should address the health problem in Algeria marked by a lack of competence and difficulty in the mobility of specialists. This platform will enable improved access to care graduates throughout the country and especially the sharing of information between health professionals to ensure continuity of care (CDER, 2014).

In Some Countries In recent years, many countries have tried to apply information and communication technologies to the healthcare system and especially to THC. In the study of (Nakajima, 2001), the status of telehomecare in developing countries in Africa and other regions differs from that in other areas. The problem is accentuated by a lack of infrastructure and health personnel. In the work of (Huang, 2011), an information platform for tele-healthcare services was implemented. The platform deployed a service-oriented architecture, which consisted of HL7 standard messages and web service components. The prototyping system was pretested and evaluated in a homecare department of hospital and a community management center for chronic disease monitoring. In Canada, the effectiveness of home tele-healthcare for diabetes is studied and proposed a decision framework to address complex issues of adopting home telehealth technology into practice (Marilynne, 2006). In general, it has been concluded that home telehealth systems produce accurate and reliable data and capable of improving patient management (Guy, 2006). The aim of (Lindberg, 2013) was to review existing studies describing the use of ICT in home care for communication between patients, family members, and healthcare professionals. The authors of (Barreda et al., 2013) present a Web-based application that calculates the risk of suffering from type 2 diabetes (Diab_Alert). The use of the tool does not replace a diagnosis by a physician, but it holds the promise of enhancing users’ awareness of the disease. The tool has been designed to be easily translated into multiple languages and to work on multiple platforms, with a standard version for computers and a simpler version for mobile devices. The work of Tollinsky (Tollinsky, 2012) described the recent incorporation of “telehomecare” services for older adults living with chronic disease in Northern Ontario communities. Kort and Hoof (Kort & Hoof, 2012) distinguished three categories of THC technologies: (i) remote telecare, (ii) activity monitoring, and (iii) a category comprising telemedicine and e-health solutions and services. There are numerous barriers to the implementation of Dutch THC technologies projects.

TELEHOMECARE ARCHITECTURE The principle of our system is to collect measured data, including weight, blood sugar level, body temperature, and blood pressure results from various physiological measuring instruments using Bluetooth

692

 Towards a Telehomecare in Algeria

wireless technology to transmit and save these data via the Internet to a remote database stored in cloud. The proposed architecture supports THC (see Figure 1). This architecture is based on agents, cloud and ontology. Each actor (doctor, nurse, etc.) of hospital is assisted by a software agent named User Agent (UA). The behavior of the agent is more organizational in the sense that it knows how to take into account the other members of homecare organization and to update its organizational knowledge. This architecture aims to facilitate the interoperability, the accessibility to information, and it supplies to homecare actors the same functionalities as if they belong all to a single structure (the same place). Indeed, the main aims of our architecture to summarize in three points: (1) reducing delays in the management of patient (2) improve the efficiency of the THC team (3) and therefore, improve the service provided to patients and their satisfaction. A Virtual Private network (VPN) is established between all Information systems of the hospital, patient home and the data centre using wireless network links between them. This is achieved by sourcing the services from an Internet Service Provider (ISP). The measured data are transmitted via wireless connection; the information can be received via smart devices and uploaded in XML format through Internet. After, the system receives, processes and saves the data to the corresponding database location. To this aim we use primarily the BluetoothTM standard which is available on almost every mobile phone as well as on a large and ever growing number of medical devices such as glucometers, blood pressure monitors, etc.

Why a Software Agent? Telehomecare is situated in a mobile environment and emerging a distributed knowledge. Its quality relies on competences, qualifications, and the cooperation of the health actors. Generally, these actors do not work together. So, it is necessary to assure a permanent interaction between them. In this perspective, the multi-agent paradigm proposes interesting concepts for THC development, such as control autonomy Figure 1. The proposed architecture

693

 Towards a Telehomecare in Algeria

and the communication. Agents are capable of interacting between them to interpret and accomplish their tasks. In fact, agents form a cooperative and intelligent system. Also, the communication mechanisms recommended by the agent approach provide elegant and satisfactory solutions. In this work, the idea is to build an agent-based architecture, which supports the flexibility in THC.

Why an Ontology? In the field of health, not enough ontologies are relating to the domain of homecare. Besides, those that concern this domain do not answer all our requirements. The taking care at home of a patient implicates a cooperation of several actors. These actors share an important number of medical information. The diversity of actors implicated in the management of care in situation of THC and their specialties (doctors, nurses, etc.) can result in semantic conflicts during the interpretation of transmitted medical information. The problem is that there is not an established consensus on definition of the different terms used. These terms risk having multiple interpretations. This type of semantic ambiguity can result in a bad understanding. For it, ontology is seen as a candidate solution.

User Agent (UA) It is an intelligent agent. It assists and helps an actor (doctor, nurse, etc.) that participates in the taking care of patients. Every user agent in the system can communicate with another one without passing by an intermediary.

Local Data Each database is designed to satisfy local needs and not necessarily to interact with other local databases. Indeed, the actors of THC and patients are very attached to their personal notes for their own use. But it is essential to share this information with other stakeholders.

Hospital Authorities They act on behalf of the hospital. These authorities have a number of powers: recommendation, decision, regulation and sanction. They also ensure some form of control over different medical staff.

PUBLIC CLOUD SUPPORTING THC Cloud computing presents an opportunity for healthcare providers to improve patient care, protect their privacy and mitigate the risks associated with implementing expensive technology as healthcare providers pay only for the services they use, without having to incur upfront infrastructure costs (Kalai, 2014). Currently, most Algerian hospitals do not have the sufficient technological capabilities to build a private cloud. Indeed, the choice is oriented towards the public cloud. Therefore, it is important to ensure that the provider has been in the business of providing cloud related services to healthcare related organizations, this is to ensure HIPAA (Health Insurance Portability and Accountability Act) compliances.

694

 Towards a Telehomecare in Algeria

With public cloud, stakeholders can collaborate in real time and share information without the need to invest in expensive infrastructure. The proposed solution delivered as cloud service provides a centralized platform for stakeholders of THC to access Electronic Medical Records (EMR), prescriptions and reports from anywhere in Algeria. Having a central storage area for patient information will reduce the risks of misdiagnosis and prescription of the wrong medication. It will also eliminate probability of conflicting treatments involving multiple healthcare professionals.

Control Agent It is a reactive agent. This agent must manage all associated databases in the data center to make their manipulation uniform. Also, the control agent manages data security and protection of privacy of patients and actors (confidentiality). Thus, it uses authentication and encryption mechanisms. It controls all the formulated queries to databases (radiology data, laboratory data, etc.). The solution of the control agent allows full control of UA, the voluntary or involuntary access to shared medical records which may contain sensitive data. The authentication system allows actors to prove easily their identities and get access to shared databases without threatening the security of system. Control agent has the advantage of supporting the independence.

Cloud Based EMR and Ontology At this level, this is to ensure the entire life cycle of stored medical data of patients. Each database is not only a trace of information, but also a tool for communication, information and coordination between the different structures of the hospital to taking care of patients. The medical actors will be able to access the THC’s databases via Internet with any mobile device. The patient will access his medical records using credentials from these devices. Each actor has his own credential key automatically generated and delivered by the hospital authorities to access data. So, databases are composed of: • • •

Homecare ontology. Medical knowledge. Relating to disease and medicine. Electronic medical record. The medical record is an essential tool to share information for cooperation.

Electronic Medical Record Hosted in public cloud, EMR consists of an important amount of information. The EMR is stored and capable to be consulted even from distance. The sharing of medical information is vital in medicine concerning at the same time: diagnosis, prognosis, analysis and care continuance. It is a progress factor for better medical care, faster and adapted, and so, systematically transmits information to other participants. To improve information traffic and functioning of our approach, the medical record is primordial, it helps to: (i) Minimize medical errors, (ii) Accelerate knowledge diffusion and (iii) Help decision making. Electronic medical record is brought to evolve and to be updated more frequently. It allows a permanent communication between actors in an interprofessional context in order to cooperate, and to inquire mutually their conclusions’ result and actions. Every actor has to find any indication and any information

695

 Towards a Telehomecare in Algeria

which is useful for understanding situations: to keep information traceability, to orchestrate, to organize interventions, to share and to exchange information to assure the coherence interventions, the continuance and the care quality. Cloud based EMR guarantees the interoperability among UA in the sense of coordination to collect, enrich and exchange structured medical data. Furthermore, a virtual collaborative working space reserved for all user actors allows them to work while being geographically distant and by keeping a permanent assistance around the patient. Each of Patients, doctors and nurses use their mobile handset for accessing the medical record stored in public cloud database. Each of the actors will have different level of access to the EMR. This is part of the security measures to prevent any leakage of important record. Therefore, the actor needs to be authenticated before being able to view the available record. The various functionalities of actors are shown in Table 1.

Homecare Ontology Towards Semantic Interoperability It is essential to favor the semantic interoperability for a common and homogeneous understanding of data. The specificity of semantic interoperability defines a common language allowing actors to interpret in a homogeneous way the nature and the values of data transmitted without ambiguities (since a message can be interpreted in several ways) to reason, and to reuse them without error or loss of information. Our contribution also concerns the representation of these data and these knowledge (at the semantic and syntactic level) to allow their sharing, their reusability and especially to reason in order to take a decision. Indeed, the semantic conflicts result from different interpretation of information shared between various actors of homecare. These last years, ontology became a subject of appreciated search in different communities, for a better exploitation of information and the semantic sharing between the medical information systems which became a challenge. It is a separate domain of the search in engineering of the knowledge and their reusability. Ontology is very promising and participates to surmount the semantic interoperability problem indispensable to communication and exchange data particularly in medicine. We intend at present to use a simple ontology with concepts simplified to enrich our work, putting in evidence the structures of common information. This turns out indispensable to assure common semantics between human agents of homecare, i.e. the formal information. Although this ontology is directed for the communication between persons, but its integration within a computer system to assure Table 1. Some actions of actors on EMR Actors Cloud-based EMR

Doctor

Nurse

Search patient medical record

X

X

Add patient diagnosis result

X

X

Make prescription

X

View Prescription

X

X

Patient

X

View patient personal details

X

X

X

View patient medical history

X

X

X

696

 Towards a Telehomecare in Algeria

the interoperability between agents software is also possible. An example of logical axioms used in ontology is the following: (…….) //--- The following axioms allow to define the domain, the co-domain and the relations characteristics. ---// ∃HasForDocument.T⊆Patient T⊆∀HasForDocument.Document HasForDocument≡isDocumentOf T⊆≤1isDocumentOf ∃contain.T⊆PrescriptionMedicinal T⊆∀contient.ElementPrescription contain≡Part T⊆≤1Part (……..) //--- The following axioms allow to define the domain and the co-domain of an attribute example which is name. The same is realized on all the attributes of every concept. ---// ∃name.T⊆Person T⊆∀name.string ∃ age.T⊆Person T⊆∀age.int (…….)

Action Plans Our ontology is also seen as a library of action plans. Indeed, it contains (i) a set of plans directed by the global purpose (taking care of patients) and sub-purposes (care of the sick, therapy, etc.) useful for the processes of planning and coordination. These two concepts are the subject of our forthcoming article. (ii) A set of information necessary for actors to realize their tasks. Every plan is characterized by the actions to be executed and the resources to be used. Example: nurse send an activity report to the doctor explaining the actions performed in order to determine the patient’s status. The task is to give the patient’s daily status (Ex. diabetic). The plan is (set of actions to be performed): 1. 2. 3. 4.

Measure the weight Check blood pressure Check body temperature Check blood sugar level

Furthermore, to better understand the implementation of the plan, and as XML will be used for the description and interpretation of the content of the messages exchanged between the different user agents. XML perfectly illustrates the structure of the plan to execute.

697

 Towards a Telehomecare in Algeria

COMMUNICATION AND TOOLS XML Based Message In eHealth is mandatory to use a standardized communication. The development of Telehomecare is also based on standards. They have a significant contribution to interoperability in the THC. Among our contribution’s objectives, are to encourage and push the evolution of normalized standards, to support the reusability and the interoperability in the field of distributed medical information. The need to transmit data in a structured form allowing automatic processing has resulted in the development of standard messages. Therefore, it is relatively easy to interconnect systems. Making them interoperable requires an agreement on the structure of exchanged data. But it is not always easy to interconnect systems. For this purpose, the international standardization in the field of health plays a vital role to ensure some interoperability in medical information exchange. It should also be noted the predominant place occupied by the XML standard. XML is the standard of data description. This standard promotes the convergence of all standards and norms above (Umer, 2009). In our proposition, all exchanges of messages and information are based on XML.

Agent Communication Protocol The success of our approach also depends on an effective communication throughout its progress. To analyze data, identify information, maintain knowledge, communicate syntheses, recommendations and decisions-making of agents that are different in their functions and activities, require an unfailing communication. So, it is necessary to assure a permanent communication. Several mechanisms of communication are possible: message exchange, methods invocation and the use of the “blackboard” mechanism. Consequently, standardized inter-agent communication languages should be supplied. In our approach, we use the ACL to formulate messages and the XML to describe the contents of messages. The use of ACL-XML in inter-agent communication permits to achieve a first level of interoperability by surpassing the problem of heterogeneous exchanges among the different actors in the hospital. The success of the information diffusion among actors resides certainly in the communication protocols standardization. The following example illustrates the use of a message in ACL FIPA containing a report structured in XML: (inform :sender User agent1 (Nurse) :receiver User agent2 (Doctor) :language XML :content (

Anonymous Anonymous Male …

< clinical exam> 65

698

 Towards a Telehomecare in Algeria

< blood sugar > 1,35 < blood pressure > 135-95 < body temperature > 37

) )

Sensors These devices replace the necessity of manual data gathering. The sensors collect different vital signs. The types of vital signs may include blood pressure, pulse rate, body temperature, etc. There are several practical advantages in using these devices, such as: • • •

It provides always-on, real-time data collecting; It eliminates manual collecting work and possibility of typing errors; and It facilitated the deployment process, as wireless networking means no need for cabling or another physical setup.

Mobile Tools In the last few years, mobile technologies in particular emerged and become very important. Some countries reached an effective penetration of 100% such as Finland. In 2012, there are 35 million users of mobile phones in Algeria that represent 95% of the population (Lezzar, 2013). All current phones can access wireless data networks whenever the phone has a signal, through GPRS, 3G, 4G connections or even through Wi-Fi (wireless fidelity), that enables data exchange via the Internet. Telehealth systems in the form of online and mobile tools are already opening up the possibilities for reduced hospitalization and an increased homecare (Venter, 2012). Indeed, ICT tools can be used to access a wide variety of technological solutions for communication, including text messaging, gathering and monitoring data, diagnosis and treatment at distances, and retrieving electronic health records (Koch & Hägglund, 2009). Actors of the THC are different in terms of forming, competence or task to be carried out. This variability is translated by a perception mechanism of knowledge and various access modes to information. Then, it is necessary to take into account this variety, to offer to the actors the adapted and efficient interaction modes, a better diffusion, and a data acquisition to interoperate. Mobile tools such as smart phone constitute a real condition for the THC success. Their uses on behalf of all the participating actors appear to be: the power to share information, knowledge and taking decisions through cooperation.

The Android Applications The Android applications are responsible for providing doctors, nurses and patients with access to the relevant Cloud-based EMR. In particular, two Android applications have been developed, one for the doctors- nurses and one for the patients with different interfaces.

699

 Towards a Telehomecare in Algeria

Doctor-Nurse Application This application enables doctor or nurse to monitor patients’ health remotely by observing parameters measured by patients themselves and, if needed, to form the appropriate treatment plan for them. To this end, doctor- nurse application interfaces with cloud-based EMR and Homecare ontology. The access to EMR data and ontology can be performed only by authorized users. The main user interface of doctor- nurse application prompts the user to enter his user name and password in order to validate the user’s credentials. Thus, authorized users may view or update certain portions of an EMR according to the privileges they possess.

Patient Application Patient application enables patients to be guided through their treatment plans. Moreover, patients can update their health information either manually with non-clinical information or automatically with vital sign measurements (e.g. blood glucose and pressure, weight etc) via Bluetooth.

DISCUSSION AND EVALUATION The proposed architecture allows the remote monitoring of diabetics at home and sharing of information between partners in a distributed environment in a hospital in the context of developing countries such as Algeria. Telehomecare makes it easier to exchange medical information and restrict time and location constraints. Telehomecare of diabetics at home offers important benefits, mainly in terms of a significant reduction in the number of emergency room visits and hospitalizations. The most important is to involve patients as partners in their therapeutic plan. On the economic plan, patient and government can save money compared to traditional homecare. The proposed architecture can be widely used for telemedicine. Moreover, this architecture can be used for solving problems in which there is an interaction of various professionals of health. During this work, we are confronted with several difficulties in knowledge extraction of homecare domain seen the lack of traces of the different actors in a real organization, on one hand. On the other hand, the Algerian medical sector widely did not adopt homecare. Consequently, the health professionals supposed experts of domain lacked a clear conception of such care organization. To situate our work in the domain of telemedicine and particularly in telehomecare, the Table 2 compares our system with other systems proposed in Algeria, and Table 3 gives the some differences between traditional homecare and telehomecare in the context of diabetics. Homecare particularly affects the elderly and telehomecare can widely concern various types of age. Key benefits of using this architecture: • • • • •

700

Real-time Services (e.g. to support remote medical consultations) Health actors and in particular doctors can easily access test results previously made, and information about patients. Avoid unnecessary interactions between health actors. Efficiency side, health actors spend much less time and effort to search information, which allows to organize activities and to avoid delays in care. Patients undergo fewer redundant tests.

 Towards a Telehomecare in Algeria

Table 2. Comparison of works Project (SanteDZ, 2002) Concerned domain

WHO-ANDS

EMISPHER

HealthAlgeria

(Hocini et al., 2008)

(CDER, 2014)

Our work

DZ-RT

DGRSDT

ABAH

Tele-expertise

X

Tele-consultation Tele-learning

X X

Tele-assistance

X

X

X

X

X X

Tele-education

X

Tele-homecare

X

Table 3. Traditional homecare and Telehomecare Traditional homecare

Telehomecare

Uninterrupted monitoring

high

very high

Avoided complications

high

high

Reduced medical consultations

high

very high

Useless displacement

low

high

Avoided hospitalisation

high

very high

Avoided desocialization

high

high

Degree of data availability

low

high

Specially reduction in: • •

Home visits (lack of doctor and nurse) Hospital stays (limited number of beds and hospitals) Disadvantages:

•

High cost of equipment

SOME IMPLEMENTATION ASPECTS Even though the current status of the project is in the research phase, and in order to study the feasibility of the proposed architecture, we implemented a first prototype using standards. We used XML technology to represent the information exchanged among agents via the standard communication language ACL-FIPA (the possibility of using standards like HL7 v3 message, CDA, DICOM, etc. encoded in XML (Orgun & Vu, 2006)). Indeed, the system can interact with other applications in hospital for ex-

701

 Towards a Telehomecare in Algeria

ample through the XML exported files. The platform which gets closer most our criteria is JADE (Java Agent Development Framework) along with Lightweight Extensible Authentication Protocol (LEAP) (Jade, 2007) Android 4 and MySQL. JADE is a platform of agents’ creation that takes into account FIPA specifications for the Multi-Agent Systems (MAS) interoperability. Creating a JADE agent is as simple as defining a class extending the core.Agent class and implementing the setup() method. The setup() method is intended to include agent initializations The UserAgent which is on the user’s Smartphone is independent on the other agents in the system and therefore if any agent was to stop working then this would not affect the system, which is an explicit feature of the system. The following Java code represents the implementation of the UserAgent class. These classes are extensions of the basic Agent class defined in JADE. public class UserAgent extends Agent { class percevoir extends SimpleBehaviour {       public percevoir(Agent a)       {       super(a);       }       public void action() {       … ACLMessage msg = blockingReceive(); if (msg!= null){ switch(msg.getPerformative()) {                 // Processing…            …

To understand the feasibility of our work a case study is necessary. The goal is to take charge a diabetic person. We are motivated by the national study of multiple indications conducted by the Ministry of Health, Population and Hospital Reform, in collaboration with the National Statistics Office and representations of Nations, that the pathology of diabetes in the second, behind high blood pressure. According to these data, the number of people with diabetes is increasing almost. Algeria has nearly 3 million diabetics. Every doctor, nurse or patient starts the application and authenticates before any activity. Regarding the person with diabetes the measures taken are detected by the appropriate tools and transmitted via Bluetooth to the mobile phone. This last sends information to the hospital database. However, measures can be taken and entered manually for some reason or another. The patient can consult his measurements, medical records and update personal information (see Figure 2 and Figure 3). However, each actor can record their own personal notes everyone in his local database. The doctor can see the list of his patients, selects a patient and consults the daily state of the patient via the measurements taken and their medical history (see Figure 4 and Figure 5). He can make decisions as prescription, diagnostic, etc. However, if the doctor wants to make a home visit, he can localize the place of his patient (see Figure 6). The nurse consults the patient records and monitors their status. She can consult the list of her patients, selects a patient and consults the daily state of her patient via the measurements taken. In the case of a home visit, she can locate the place of his patient (see Figure 6).

702

 Towards a Telehomecare in Algeria

Figure 2. Patient measurements manual input screenshot

Figure 4. List of patients

Figure 3. Patient measurements screenshot

Figure 5. Doctor interface

703

 Towards a Telehomecare in Algeria

Figure 6. Patient localisation screenshot

We give in Figure 7 a partial view of the binary relations diagram of the homecare ontology, and in Figure 8 homecare ontology illustrated in Protégé (Protégé, 2007). In Table 4 we define some assertions. Indeed, an ontology is vital for the telehomecare (i.e. badly interpreted information can put in danger the life of the patient). Figure 7. A partial view of the binary relations diagram

704

 Towards a Telehomecare in Algeria

Table 4. Assertions of concepts and relations Concept Doctor

Description Hatem: Doctor

Relation Monitor-Patient

Description (Hatem, Kamel): Monitor-Patient

Nurse

Sarah: Nurse

Monitor-Patient

(Sarah, kamel): Monitor-Patient

Patient

Kamel: Patient

Attained of

(Kamel, Diabetes)

Chronic illness

Diabetes: Chronic illness

Use

(Treatment07, Insulin): Use

Figure 8. Homecare ontology illustrated in Protégé

CONCLUSION In this paper, we have presented an information system architecture supporting telehomecare for diabetes measurement and remote monitoring in Algeria. This architecture is based on agents, ontology and cloud. This architecture allows interoperability and easy data access. Also, it facilitates flexible interaction between health professionals, and between health professionals and patient through the Internet. Software agents help to ensure the availability of data in healthcare and can be used to support processes, for example, information retrieval. Every agent assists an autonomous actor. These actors are geographically scattered belonging to diverse information’s systems of hospital. In the current state, we are inclined to the evolution and the experiment of system to determine the difficulties and possibly, to envisage several improvements or possible extensions. We intend to implement a dedicated security system, with the aim of guaranteeing the respect for the medical secret, the data security and functionalities accessible to stakeholders, to assure the coherence in terms of the data confidentiality and the deontology. In terms of future work, it is desirable to deploy our architecture in a realistic environment to further evaluate and improve our study.

705

 Towards a Telehomecare in Algeria

REFERENCES Barreda-Pérez, M., de la Torre, I., López-Coronado, M., Rodrigues, J. J., & García de la Iglesia, T. (2013). Development and evaluation of a Web-based tool to estimate type 2 diabetes risk: Diab_Alert. Telemedicine Journal and e-Health, 19(2), 81–87. doi:10.1089/tmj.2012.0110 PMID:23336735 Bergenti, F., & Poggi, A. (2009). Multi-Agent Systems for e-Health: Recent Projects and Initiatives. Retrieved from http://cmt.math.unipr.it/woa09/ papers/Bergenti2.pdf Bowles, K., & Baugh, A. (2007). Applying research evidence to optimize telehomecare. The Journal of Cardiovascular Nursing, 22(1), 5–15. doi:10.1097/00005082-200701000-00002 PMID:17224692 Braa, K., & Nielsen, T. (2013, 19-22 May). Leveraging the Potentials of Mobiles in Developing Country Health Initiatives: From ICT4D to Information Infrastructures 4D. Proceedings of the 12th International Conference on Social Implications of Computers in Developing Countries, Ocho Rios, Jamaica (pp.132-143). CDER. (2014). Towards the generalization of tele-medicine in hospitals. Retrieved from http://portail. cder.dz/spip.php?article3898 Chung, L. T., Theng, L. B., & Seldon, H. L. (2014). An Android Mobile-Based Environmental Health Information Source for Malaysian Context. In M. Househ, E. Borycki, & A. Kushniruk (Eds.), Social Media and Mobile Technologies for Healthcare (pp. 173–200). Hershey, PA: IGI Global. doi:10.4018/9781-4666-6150-9.ch011 Demiris, G. (2004). Home based e-health applications. In G. Demiris (Ed.), E-Health: Current Status and Future Trends, Studies in Health Technology and Informatics, 106 (pp. 15–24). Amsterdam, Berlin, Oxford, Tokyo, Washington DC: IOS Press. Fox, J., Beveridge, M., & Glasspool, D. (2003). Understanding intelligent agents: Analysis and synthesis. AI Communications, 16(3), 139–152. Guy, P., Mirou, J., & Claude, S. (2007). Systematic Review of Home Telemonitoring for Chronic Diseases: The Evidence Base. Journal of the American Medical Informatics Association, 3(14), 269–277. PMID:17329725 Hocini, H., Oudjoudi, I., Ahmane, H., Abbassene, A., Boumaraf, M., & Sekkai, L. (2008, March 14-19). La telemedecine pour le desanclavement des zones sahraoui en Algerie. Paper presented at the Congrès Méditerranéen des Télécommunications (CMT), Tangier, Morocco. Huang, E.-W., Rung, R.-S., Chiou, S.-F., Liu, F.-Y., & Liou, D.-M. (2011). Design and Development of a Tele-Healthcare Information System Based on Web Services and HL7 Standards. In H.R. Arabnia and Q.-N. Tran (Eds.), Software Tools and Algorithms for Biological Systems, Advances in Experimental Medicine and Biology (pp. 599-606). Springer. 10.1007/978-1-4419-7046-6_61 Isern, D., Sánchez, D., & Moreno, A. (2010). Agents applied in health care: A review. International Journal of Medical Informatics, 79(3), 145–166. doi:10.1016/j.ijmedinf.2010.01.003 PMID:20129820 Jade. (2007). Java Agent DEvelopment Framework. Retrieved from http://sharon.cselt.it/projects/jade/

706

 Towards a Telehomecare in Algeria

Kalai, A. R., Dominic, P. D. D., & Ramayah, T. (2014). A Structural Equation Modeling Approach for the Adoption of Cloud Computing to Enhance the Malaysian Healthcare Sector. Journal of Medical Systems, 8(38), 1–8. Koch, S. (2006). Home telehealth: Current state and future trends. International Journal of Medical Informatics, 8(75), 565–576. doi:10.1016/j.ijmedinf.2005.09.002 PMID:16298545 Koch, S., & Hägglund, M. (2009). Health informatics and the delivery of care to older People. Maturitas, 3(63), 195–199. doi:10.1016/j.maturitas.2009.03.023 PMID:19487092 Kort, H. S. M., & Hoof, J. (2012). Telehomecare in the Netherlands: Barriers to implementation. International Journal of Ambient Computing and Intelligence, 2(4), 64–73. doi:10.4018/jaci.2012040105 Koufi, V., Malamateniou, F., & Vassilacopoulos, G. (2013). An Android-Enabled PHR-based System for the Provision of Homecare Services. International Journal of Measurement Technologies and Instrumentation Engineering, 3(2), 1–18. doi:10.4018/ijmtie.2013040101 Lezzar, F., Zidani, A., & Chorfi, A. (2013). Enabling coordination within medical settings: Case of a maternity ward. Applied Medical Informatics, 2(32), 39–46. Lindberg, B., Nilsson, C., Zotterman, D., Söderberg, S., & Skär, L. (2013). Using Information and Communication Technology in Home Care for Communication between Patients, Family Members, and Healthcare Professionals: A Systematic Review. International Journal of Telemedicine and Applications, 2013, 1–31. doi:10.1155/2013/461829 PMID:23690763 Marilynne, A., Korabek, B., & Scott, R. (2006). Moving Research into Practice: A Decision Framework for Integrating Home Telehealth into Chronic Illness Care. International Journal of Medical Informatics, 75(12), 786–794. doi:10.1016/j.ijmedinf.2006.05.041 PMID:16872892 Nakajima, I., Zhao, Y., & Juzoji, H. (2001). IP-ECG for Telehomecare. Retrieved from www.itu.int/ AFRICA2001/forum/speeches/nakajima_pap.doc Nourizadeh, S. (2011). Un système de télésanté contextuel avec support de qualité de service pour le maintien à domicile [PhD thesis]. Institut National Polytechnique Lorraine, France. Orgun, B., & Vu, J. (2006). HL7 ontology and mobile agents for interoperability in heterogeneous medical information systems. Computers in Biology and Medicine, 36(7-8), 817–836. doi:10.1016/j. compbiomed.2005.04.010 PMID:16139263 Protégé. (2007). Protégé tool Stanford University. Retrieved from http://protege.stanford.edu/ SanteD. Z. (2002). Programme action. Retrieved from http://www.sante.dz/intranet/programme-action.htm Smith, J., & Sankaranarayanan, S. (2012). Smart Agent-Based Hospital Search, Appointment, and Medical Diagnosis. International Journal of E-Health and Medical Communications, 3(4), 64–10. doi:10.4018/ jehmc.2012100105 Stachura, M. E., & Khasanshina, E. V. (2007). Telehomecare and Remote Monitoring: An Outcomes Overview. Retrieved from http://www.viterion.com/web_docs/TelehomecarereportDiabetesandCHRMetaAnalyses.pdf

707

 Towards a Telehomecare in Algeria

Subalakshmi, R. J., Das, A., & Iyengar, N. C. S. N. (2011, October 2-4). A small e-health care information system with agent technology. Proceedings of the International Conference on Computational Intelligence and Communication Networks (CICN), Gwalior, India (pp. 68-72). Tambo, T., Petersen, N. H., Pedersen, E. B., & Bejder, K. (2010). Coherent national IT infrastructure for telehomecare - a case of hypertension measurement, treatment and monitoring. Engineering and Technology, 47, 758–765. Tollinsky, M. (2012). Telehomecare programs rolling out across the north. Northern Ontario Medical Journal. Retrieved from http://www.nomj.ca/2012/12/01/telehomecare-programs-rolling-out-acrossthe-north.html Umer, S., Afzal, M., Hussain, M., Ahmad, H. F., & Latif, K. (2009, May 01). Design and implementation of an automation tool for HL7 RIM-to-rational database mapping. Paper presented at the 10th International HL7 Interoperability Conference (IHIC), Kyoto, Japan. Venter, A., Burns, R., Hefford, M., & Ehrenberg, N. (2012). Results of a telehealth-enabled chronic care management service to support people with long-term conditions at home. Journal of Telemedicine and Telecare, 18(3), 172–175. doi:10.1258/jtt.2012.SFT112 PMID:22362838 Zarour, K. (2015). Agent and Mobile Tools for Telehomecare in Developing Countries: An Architecture Approach. International Journal of Interactive Mobile Technologies, 9(2), 31–36.

This research was previously published in the International Journal of E-Health and Medical Communications (IJEHMC), 8(4); edited by Joel J.P.C. Rodrigues, pages 61-80, copyright year 2017 by IGI Publishing (an imprint of IGI Global).

708

709

Chapter 35

Virtual Carer: A First Prototype

Aldo Franco Dragoni Università Politecnica delle Marche, Italy

ABSTRACT In view of the rapidly progressive increase in the average population age, “Ambient Assisted Living” (AAL) defines the actions and policies needed to promote the improvement of living conditions within domestic spaces to foster autonomy, safety, and social inclusion for the elderly or disabled. The idea is to design an innovative and comprehensive information system for AAL, an ICT-based “Virtual Caregiver,” which is informed, intelligent and friendly, and which constantly monitors the health warning, informing and advising the elderly while controlling the environment and then asking for help when needed. The system will have the ability to establish interactive communication with the person but also extend it automatically outside the house in times of need. Virtual Caregiver will be able to enable the software protocols that activate the emergency phone calls to the family, medics or even first aid in emergencies.

INTRODUCTION Aging well is one of the most important challenges of the west world. Ambient Assisted Living (AAL) is an initiative from the European Union to address that problem by reducing barriers, through ICT innovation, with the goal to lower social security costs and allow the elderly/disabled to live comfortably in their (nursing) homes (AAL 2009). The main objectives declared by the European AAL are: • • • • • •

Extend the period in which people can live in their preferred environment by increasing their autonomy, self-sufficiency and mobility. Help maintain health and functional capacity of older people. Promoting lifestyles and better health for people at risk. Increase safety, prevent social exclusion and maintain relational network of people. Supporting the players, families and organizations of care. Improving the efficiency and productivity of resources in an aging society.

DOI: 10.4018/978-1-5225-7122-3.ch035

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Virtual Carer

The themes of “good aging” and AAL activities are the focus of numerous research programs and of the new European perspective of Horizon 2020. But AAL is not just technology: it requires in all its phases, from conception to implementation and use, collaboration and effective communication between researchers, planners, industry, users, administrators, social workers and health care, in a completely new operating paradigm, challenging and stimulating. The purpose of this article is to shed light on the key technologies involved in the design of an ICTbased innovative and comprehensive AAL-oriented information system. The hazard of being subjected to restrictions on their autonomy and independence grows rapidly over the age of sixty, and the home environment is one of the scenarios where severe limits of autonomy occur, along with independence related diseases and disabilities.

BACKGROUND Most of the AAL projects provide ICT platforms to create and maintain an easy-to-use web-based social network for the elderly in order to stimulate their social relations. Timely information are transferred to the network on the activities and subjective state of the elderly person (e.g. presence, state of wellness, etc.) allowing for a much better-tailored and timely response, attention and care so as to improve and maintain the well-being and independence of the elderly living in their own homes and reduce healthcare costs. The AAL projects address chronic conditions such as mild cognitive impairment, and develop and test solutions to alleviate and/or prevent them. In such a way, caregivers, friends and family members have greater access to information about the person, and those at a distance are enabled to keep in touch and share activities with their elderly family member or friend, and to know their current condition. Despite these advances, we believe that it is necessary to find and test new services exploiting the potential of ICT to implement socially advanced and reliable services, “smart” technology-based communication and information processing that must be adapted to the needs of the elders (Weber 2005) (Weiser 1996) so that they derive real benefits in terms of autonomy and security. To illustrate what we are thinking about (at the Laboratory for Artificial Intelligence and Real Time Systems of the “Università Politecnica delle Marche,” in Italy) I need to tell a personal story. Some time ago, when my father (widow) was still alive, I experienced some difficulties which are very common in the west world, where sons live far from their old parents. My problem was that when I called my father, who lived a hundred miles from my home, he often did not answer the phone. And this happened more than once in succession so that I was forced to take the car for a long trip anxious to go and see what had happened to my father. Systematically the causes of the fact that he did not answer the phone was that, during the first phone call my father was in the garden, while the second was in the bathroom and while the third was sleeping! Paradoxically, my problems disappeared when his worse! In fact, when his health worsened, my father was forced to hire a nanny. The caretaker of my father answered the phone in his place, and kept me well informed about the health and mood of my father. She also called me when he needed something from me. Unfortunately, in the future, the socioeconomic equilibrium of the western world will probably make it difficult for the next generations of elderly to hire personal caretakers. After this consideration, I immediately realized that almost all the informative tasks performed by the nanny could also be provided by a well designed and skilled software system! Of course it would have been a complex system that

710

 Virtual Carer

integrates various artificial intelligence technologies, from the speech synthesis and recognition, to the learning and planning of communicative acts. I tried to sketch down what were the services provided by the nanny. She: • • • • • •

Noted daily biomedical signs Remembered my father to take medication Listened to his needs Answered the phone, giving news of my father Phoned me when my father needed Kept company with my father and made him feel happy, even telling jokes.

Effectively, almost all these tasks could be provided by an intelligent software system and I started to think about what minimal integration of current technologies would be necessary to build our “Virtual Caregiver,” that became our approach to address the objectives of the AAL initiative. This paper describes our efforts devising an infrastructure in order to make the “Virtual Caregiver” vision reality.

THE “VIRTUAL CAREGIVER” Structure It will focus on the system’s ability to monitor and then acquire, interpret, and store the vital signs of a person. We are currently using two wearable devices: the BioHarness-Zephyr and the STMicroelectronics BodyGateway, both able to detect the main biomedical data (expecially the ECG) and send them to the Virtual Caregiver through IEEE 802.15.1 - Bluetooth. They cover most of the biomedical parameters essential for use in the project to ensure an older person’s safety and service through continuous health monitoring. However, data need to be interpreted. So it is important to map collections of data into “living scenarios” that will be given as input to the Virtual Caregiver in order to let it adopt some specific protocols of action and communication. We believe that the Virtual Caregiver should act continuously in normal living conditions, and should be considered as a clerk or a friend, and not be associated only with pains or emergencies. However, the most important scenarios to be recognized will be those referring to specific emergency situations relating to the health and security of the assisted person in her home environment. To accomplish the task of going from pure data to descriptive scenarios we must provide our Virtual Caregiver with its own intelligence; an “Interpretative System,” i.e. an inference engine that applies to the Knowledge Base (KB) consisting of all the external signals “facts” that come both from the wearable and the environment sensors (detecting temperature, open/closure of windows and door etc.) placed in various rooms. To Interpretative System is basically implemented in Prolog, and exploits the potential of deductive and abductive paradigms. In particular we adopt an hybrid structure composed of the Java language and the language TuProlog, this latter written entirely in Java. At this stage it has proved extremely useful to build an application using different programming paradigms simultaneously. The recognized scenario is inputted to a “Talking Head” which, for now, is a prototype based on “Lucia” which was made in January 2005 by the Institute for Cognitive Sciences and Technologies (ISTC) of the

711

 Virtual Carer

National (Italian) Research Council at Padua. “Lucia” communicates with the older person by using a system of automatic synthesis bimodal audio-visual and is able to activate other specific protocols, such as Voice-XML. This allows it to establish an interactive communication, as simply as possible with the assisted person and with her familiar and caregiver “entourage” to provide accurate information on her health status, or to request help in case of need. Our Virtual Caregiver integrates also a chatbot (A.L.I.C.E.). It is an interface dialoguers, able to interact with the elderly in an intelligent conversation through text in natural language. The purpose of the use of a chatbot is to make it easy and immediate to exchange relevant information belonging to a specific domain. For example, information about the home environment, health information or assistance, and other details useful to the assisted person. The domain in question will be represented by appropriate files written using the meta language A.I.M.L. (Artificial Intelligence Markup Language) that represent the knowledge base used by the chatbot. Finally it’s important to integrate all components into a single logical architecture by creating points of communication between the components. We build a software platform for simulation (simulated environment – ambient house – without the use of real sensors) to test the system’s features and potential, considering all the components involved, as in (Costa 2009). Given the high flexibility of a simulation component of this type, it can represent a number of interesting scenarios that reproduce many heterogeneous situations. In this test phase it will be of great help to use the data made available by the online database PHYSIONET.ORG. This, collects data and physiological measures in a gigantic database. This is the Harvard-MIT Division of Health Sciences and Technology at its disposal this archive known as MIT - BIH Database.

DATA ACQUISITION AND INTERPRETATION The wearable sensors (BioHarness – BodyGateway) are the main data acquisition devices of the Virtual Caregiver (see Figure 1). They should continuously monitor the health status and the proper functioning of the heart through an ECG, a respiratory rate, a temperature and an accelerometer. In particular, Figure 1. Communication of BioHarness with the virtual caregiver

712

 Virtual Carer

the BioHarness – Zephyr addresses those needs since it can detect the following vital signs: Heart Rate (BPM), Electrocardiogram (ECG), respiratory rate (RPM), Width of Breathing (mV), body posture (degrees from the horizontal axis), skin temperature (° C), acceleration of body movements (Watson 2008a). Biomedical data must be acquired, read, interpreted and analyzed. The values sent from the sensors belong to the category of “Stream Data Packet” that is, packets sent in streaming with a period of 1008 ms (Watson 2008b). To enable communication with the device we need a standard method, as well as an economical and safe one. The current solution was the IEEE-802.15.1 Bluetooth (Gratton 2003). The communication between our system and sensor-BioHarness Zephyr is half-duplex. To implement all the functionality of receiving data from the system Carer we used the Java programming language “Java - Standard Edition SE 1.6 - JDK. In order to serve the Bluetooth protocol, Java needs to have the right tools. These are called JSR-82 and BLUECOVE. The specification defines the standard JSR-82 Java Bluetooth technology and “packages” allowing the establishment and operation of Bluetooth (like L2CAP and RFCOMM) for communicating with our sensor. BLUECOVE (stack open source) is rather an implementation of J2SE JSR-82 that gives a Java client the possibility to interface with the software BLUESOLAIR Bluetooth. The latter has the main functionality of the device and can connect via Bluetooth USB Wi-Fi (Bluetooth adapter - CNET) to a computer. The application developed in Java must be able to interface with Bluetooth devices for research use (Operation of Device Discovery) (in our case the sensor) and the service it offers (Operation Service Discovery). The specification defines two Java packages: the package javax.microedition.io allows the establishment and operation of Bluetooth (like L2CAP and RFCOMM) for communication between devices. The package also offers javax.bluetooth available application functionality and Bluetooth profiles Generic Access Profile Service Discovery Application Profile. Each package is sent and received by a sensor system of specific areas. Each received package has to be recognised by the value of the fields msgid, STX and ETX. The latter uniquely identifies each type of data packet (General Packet Data) so as to recognize them, store them in the database and send them to the PROLOG inference engine. To store the biomedical parameters and the information from the environment we choose to use a MySQL Server 5.5, a Relational Database Management System (RDBMS). All the client side of the Data Base will then be handled by Java through the MySQL - Connector-J is a JDBC driver that belongs to.

INTERPRETATION SYSTEM The inference engine is the heart of the Virtual Caregiver. It is the engine that allows to operate in an “intelligent” and efficient way. It analyzes, processes and interprets data from the biomedical and environmental sensors, and tries to recognize the current scenario in which act correctly through the Talking Head. In particular, the inferential system must be able to recognize abnormal situations in the point of view of the elderly (e.g. falls, illness, forgetfulness in taking medication) or within the home environment (a window or door left open). All of this is subject to a condition of extreme importance or configurability of the system. We inserted a priori the most important needs of the person (both the physical and psychological needs), and we created appropriate rules of inference, to be fired when needed. See Figure 2 for functional blocks of the Virtual Caregiver. The interpretation system is based of well known AI techniques (particularly “abduction”), and should not be regarded as a substitute of a doctor. We do not want to replace the physician in making a diagnosis,

713

 Virtual Carer

Figure 2. Functional blocks of the virtual caregiver

but rather to assess from a range of collated biomedical data, the risk of generation of an abnormal situation. To do this the system of interpretation must rely on a knowledge base built from medical knowledge and based on a customized profile of the patient. Given a set of facts, the expert systems, thanks to its set of “production rules,” can infer new facts (Waterman 1986). For example, suppose that a person has a problem of tachycardia; we can provide expert system based on the following facts: 1. Heart rate is higher than normal (data from the sensor BioHarness). 2. The person is not doing any physical activity (data coming from Environment Sensor). 3. The respiratory rate is higher than normal (data from the sensor BioHarness). The expert system takes the facts and chooses a rule so formed: IF ((hr > 120) AND (NOT (physical activity) AND (respiratory rate> 20)) THEN (tachycardia).

Here’s an example of production rule (in Prolog) to identify another scenario of “fever”: fever:temperature (X), heartRate (X), restingActivity (X). heartRate (X):X > = 100.

714

 Virtual Carer

temperature(X):X > 38. restingActivity:acceleration (X), currentActivity (sleeping). acceleration (X):X < 0.3. notRestingActivities (X):acceleration (X), currentActivity(gymnastics).

Java is an imperative language and hence is particularly suitable to express calculations, work with objects, sequences of commands, manage strings, although is not very suitable for “symbolic elaboration.” We use Java to implement most of the features that are required for our system (virtual interactive communication, Bluetooth Manager, GUI interaction with the user, etc. ..) The symbolic elaboration is rather the ground of choice for the logical-deductive paradigm we’ve seen so far referring to Prolog. In this context we need an engine usable Prolog from Java better, which is itself a Java component, maybe available as a “jar” archive that allows easy integration and efficient interaction between the two worlds (Java and Prolog). We need a solution to allow simple and natural parameter passing in both directions: consider the flow of data from the sensor vital signs. So we require a tool that is sufficiently lightweight and easy to use. More specifically, in the context of creating a system of interpretation, we think that Java collects, parses, and classifies all practical values from the BioHarness and the Environment sensors, and passes them to the Prolog interpreter. Prolog engine then maps values within their scenarios (Symbolic Processing) using its rules-deductive logic and then returns the information about the Java based on a given scenario. Java translates this information, and allows alarm activating opportunities for all protocols operating various graphical user interfaces or protocol Voice-XML to give advice, suggestions or alarm quickly in case of need. To implement the hybrid presented, we used TuProlog, component embedded within Java applications. TuProlog is a Prolog interpreter written entirely in Java and developed at Alma Mater Studiorum - University of Bologna and implemented by the research group based in Cesena.

COMMUNICATION WITH THE ASSISTED PERSON AND HER “ENTOURAGE” Communication between the assisted people and the Virtual Caregiver is one of the most important aspects to consider. The interface will enable direct communication, which is friendly and easy to understand (Norman 2005). The interaction between person and our system should have the objective of supplying information on everything related to the environment and the health of the person (Norman 1986). The alarms that identify unusual or dangerous situations must be translated into verbal instructions to advise or reassure. A visual and aural communication is the best solution for the purpose of the work presented in this article. Human-Computer Interaction (HCI) gave us many implementations of interfaces. We adopted “Lucia,” which is a prototype created the Institute for Cognitive Sciences and

715

 Virtual Carer

Technologies (ISTC) of the National Research Center (CNR) of Padua. This monitor anthropomorphic can faithfully reproduce the human speech using a co-articulation model, designed to make lip Lucia’s more fluid and natural (see Figure 3). Lucia is able to express emotions like anger, disgust, surprise, joy, sadness and fear, and thanks to the ELITE optoelectronic system can capture the movement of facial muscles and play in the Talking Face to make it more expressive (Magno 2007). It is clear that a monitor of this anthropomorphic type falls on a full draft Virtual Caregiver, making it an integral part. Undoubtedly the eyes and face of an assistant who remains in control and can readily assist an elderly person are needed; communication resources are important for the quantity, the subtlety and effectiveness of information and guidance that can be transmitted. They are for the recipient, therefore, an invaluable aid to understand cognitive processes and memory. Lucia, is able to provide the transposition of a text written by a synthetic voice (Cosi 2002). This system adopt the “Festival” speech synthesizer (from written text, expressive and emotional) and a visible articulatory movements specific for the Italian language (a computer graphics program for the efficiency of facial surface texture). Festival is based on the technique of concatenation of speech units. This module then sends the processed data to its sound wave generation. This waveform uses the synthesis MBROLA. In the case of Lucia, MBROLA based PCM 16bit/16 KHz is used (Cosi 2008). Out Virtual Caregiver adopt another communication media in parallel: natural language communication through a chatbot interface dialogue. The chatbot simulates a human and interacts with the user through a chat (in text). The chatbot writes, communicates with this system and answers the person’s questions, or can open useful web pages. We adopted A.L.I.C.E. (Artificial Linguistic Internet Computer Entity) as one of the best chatbot open-source currently available (see Figure 4). ALICE is based on language AIML (Artificial Intelligence Markup Language), which was created in 1995 by Dr. Richard S. Wallance. The chatbot stores a knowledge base written in AIML. The calculation engine may develop a response in natural language, yielding the data structure used from AIML, including an output of natural language text, due to a request by the user in natural language and always without any form of linguistic mediation. AIML language allows the definition of non-unique “Patterns” that match the generated template automatically, by drawing from the knowledge base. Figure 3. Talking head “Lucia”

716

 Virtual Carer

Figure 4. Chatbot “ALICE”

Finally, we provided our Virtual Caregiver with the ability to extend communication outside the home. The solution is Voice-XML (see Figure 5). VoiceXML stands for Voice eXtensible Markup Language, and allows a communication (telephone or web communication) to be established outside of the house of the elderly (eg with the home of his family or with the web browser of the doctor), and is able to give Figure 5. Voice-XML

717

 Virtual Carer

useful information on the health of the elderly. This platform uses the full potential of systems of speech synthesis and speech recognition to build a new generation of systems able to access services via phone for now only accessible only via web. A typical application would be as depicted in the picture: in this case, the family of an elderly called the voice server via the telephone (VoiceXML 2005). The Voice Browser interprets the Voice-XML application code developed in response to questions posed to him (the latter with logical scheme that provides questions and answers concerning the health status of the family). When the voice system provides answers containing precise figures, the voice server sends an “http request” that invokes a script or a specific Java class contained in a Web Server part of the system inside the house of elderly person. The Web server then processes the query which will be responsible for information contained in the data. The database contains all information relating to biomedical signs and to home environment. After this operation, information and data contained in the script or Java application (Voice Application) returns control to the calling voice and the family can continue to interact with the application itself by asking more questions.

CONCLUSION This paper describes the Virtual Caregiver project currently developing at the laboratory for Artificial Intelligence and Real Time Systems of the “Università Politecnica delle Marche.” It documents the technologies needed to build this innovative ICT-based Ambient Assisted Living Tool. The Virtual caregiver goal is that of ensuring maximum autonomy to an elderly or disabled person forced to live alone at home. This was the guiding objective during the design phase. It was designed primarily for medical safety, which is ensured by acquiring the biomedical parameters of the person and therefore constantly monitoring her state of health. The implemented system uses two special wearable sensors (BioHarness-Zephyr and BodyGateway-STM) of biomedical parameters; they can detect alarm situations (fainting, falling to the ground, fever, tachycardia). To recognize all possible scenarios we needed to give to our Virtual Caregiver its own intelligence. Much time was devoted to the design of an expert system, or a system of interpretation, which can make inferences on the information content of a Knowledge Base (KB) consisting of all the signals coming from external sensors. When a particular scenario is recognized, the system delegates the Talking Head (Talking emoticons) to interact visually and vocally with the person so as to advise, warn, order or even calm. Furthermore, the Virtual Caregiver is able to establish communication with the family or with the human caregiver in cases of need. VoiceXML allows to carry on simple conversation with the assisted person or with her “entourage” by exploiting the full potential of speech synthesis and recognition even via telephone (mobile or fixed). Finally, taking into account possible work in the future, we considered the OSGi framework (OSGI 2012). It is a model of comprehensive and dynamic programming components that could be a software solution allowing the standardization throughout the Java implementation code, in order to improve and speed-up the interaction with heterogeneous devices (sensors of all types, multimedia equipment, etc..). The Virtual Caregiver makes the use of devices inside the house as transparent as possible, and then ensures the paradigm of communication with the user more natural and faster.

718

 Virtual Carer

REFERENCES AAL. (2009). Ambient assisted living - Joint programme (AAL JP) - 2008-2013. Ambient Assisted Living. Retrieved from http://www.aal-europe.eu/ Cosi, M. (2002). Modalità e Multisensorialità nella creazione di una “Faccia Parlante” in Italiano. 2002 Cdrom Proceedings of VIII Meeting of AIIA - AIIA 2002, Siena, Italy, September 10-13 Cosi, P., Caldognetto Magno, E. (2008). Festival E Lucia: TTS (Text-to-speech) e IVA (Intelligent Virtual Agent) al servizio della didattica dei disabili. Proceedings of 3rd Convegno Internazionale “Progresso e Innovazioni Tecnologiche nella riabilitazione dell’età evolutiva” Napoli, 22 Giugno 2007. Costa, R., Novais, P., Costa, A., & Neves, J. (2009). Memory support in ambient assisted living. IFIP Advances in Information and Communication Technology, 307, 745–752. doi:10.1007/978-3-642-045684_75 Gratton, D. (2003). Bluetooth profiles, the definitive guide (1st ed.). Prentice Hall. Magno, C. E., Cosi, P., & Cavicchio, P. (2007). Interfacce multimodali per l’E-Learning. In C. Delogu (Ed.), Tecnologie per il weblearning: realtà e scenari (pp. 173–183). Firenze, Italy: Florence University Press. Norman, D. A. (1986). User centered system design. Hillsdale, NJ: Lawrence Erlbaum Associates. Norman, D. A. (2005). Emotional design. Milano, Italy: Apogeo. OSGI. (2012). OSGi Alliance. Retrieved from http://www.osgi.org Voice, X. M. L. (2005). VoiceXML tutorial. Retrieved from http://www.vxml.org/ Waterman, D. A. (1986). A guide to expert systems. Reading, MA: Addison Wesley. Watson, E. (2008a, January 15). BioHarness Bluetooth API guide. Zephyr - Technology ITD. Watson, E. (2008b, 2 March). General comms link specification. Zephyr - Technology ITD. Weber, W., Rabaey, J. M., & Aarts, E. (2005). Ambient intelligence. Berlin, Germany: Springer. doi:10.1007/b138670 Weiser, M. (1996). Some computer science issues in ubiquitous computing. Communications of the ACM, 36(7).

This research was previously published in Telehealth Networks for Hospital Services edited by Vincenzo Gulla, Angelo Rossi Mori, Francesco Gabbrielli, and Pietro Lanzafame, pages 290-299, copyright year 2013 by Medical Information Science Reference (an imprint of IGI Global).

719

720

Chapter 36

Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT: Deep Learning AI to the Rescue of Home-Based Healthcare David Mendes DECSIS, Portugal Manuel Lopes Universidade de Évora, Portugal Artur Romão DECSIS, Portugal Irene Pimenta Rodrigues Universidade de Évora, Portugal

ABSTRACT The authors present a proposal to develop intelligent assisted living environments for home based healthcare. These environments unite the chronical patient clinical history sematic representation with the ability of monitoring the living conditions and events recurring to a fully managed Semantic Web of Things (SWoT). Several levels of acquired knowledge and the case based reasoning that is possible by knowledge representation of the health-disease history and acquisition of the scientific evidence will deliver, through various voice based natural interfaces, the adequate support systems for disease auto management but prominently by activating the less differentiated caregiver for any specific need. With these capabilities at hand, home based healthcare providing becomes a viable possibility reducing the institutionalization needs. The resulting integrated healthcare framework will provide significant savings while improving the generality of health and satisfaction indicators.

DOI: 10.4018/978-1-5225-7122-3.ch036

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

INTRODUCTION The societal and epidemiological conditions in developed countries have progressed in such a way that the current Public Health Systems are not adequate any longer. There is an urgent need for systems to attend the chronic conditions instead of the acute events that the health systems were designed for in the middle of the XX century. In order to develop the requirements of these next generation public healthcare systems, formal ways of evaluation and scoring have to be set up that need to take advantage of some of the emerging technological breakthroughs at hand. Among these we aimed our work at joining the capabilities of having computable extended health/disease process knowledge enriched by IoT enabled ambient assisted living to acquire large numbers of health related events at population scale. Two sections in this paper are related to the different aspects of this question. First the Clinical Knowledge representation for reasoning and acquisition based in NLP (Natural Language Processing) and second the several questions that need to be addressed when applying the IoT and SWoT (Semantic Web of Things) in the healthcare process and the public system. Regarding the Clinical KR, we found that the problem known as “Knowledge Acquisition Bottleneck” (Wong, Liu, & Bennamoun, 2012) is currently the major obstacle for the development of adequate representations of medical knowledge computable representations, namely ontologies in the specific domain and in particular in the healthcare sub domain. Trying to devise a valid solution to that problem in order to enable clinical automatic reasoning either in a local, distributed or Semantic Web fashion, different sub problems had to be addressed and solutions found are proposed and summarized in “Our Solution” section. The particular solution illustrated here is the extension of the usual DRS (Discourse Representation Structure) that usually handles single texts and our proposal that we named CIDERS (Clinical Integrated Discourse Enhanced Representation Structure) which has the extended capability of representing the whole discourse of a patient’s clinical history. First of all, we introduce the scientific question of overcoming the KAB problem and explain why it is so hard to overcome. Next the solution proposed is detailed in its various problems, and pragmatic approaches taken for the problem’s different facets. The fourth section briefly explains the rationale behind CIDERS and why it may be a natural extension of the application of ACE tools in our work. In the fifth section, we present the results obtained so far and explain the promising applicability to different clinical realities with expectable similar results. We develop then the second issue addressed in this paper that is the utilization of the IoT related technologies in Ambient Assisted Living, with all the underlying issues and possible problems that have to be circumvented and propose ways of pragmatically handle them when needed and possible. We introduce the notions of emerging Intelligent Homes (vs. Smart Homes), and finally in the last section some conclusions are drawn and summarized from the various sections of the present paper.

NOMENCLATURE AAL: Ambient Assisted Living ACE: Attempto Controlled English AI: Artificial Intelligence 721

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

BAN: Body Area Network CAT: Computer Aided Translation CIDERS: Clinical Integrated Discourse Extended Representation Structure CNL: Controlled Natural Language CORE: Clinical Observations Recording and Encoding CPR: Computer Based Patient Record Ontology CQA: Clinical Question Answering DO: Disease Ontology DR: Discourse Reasoning DRS: Discourse Representation Structure EHR: Electronic Health Record FOL: First Order Logic GS: Gold Standard ICF: International Classification of Functionality IE: Information Extraction IoT: Internet of Things KAB: Knowledge Acquisition Bottleneck KR: Knowledge Representation LAN: Local Area Network MEMS: Micro-Electro Mechanical Systems NLP: Natural Language Processing OGCP: Ontology for General Clinical Practice OGMS: Ontology for General Medical Science OWL2: Web Ontology Language Version 2 SNOMED-CT: Systematized Nomenclature of Medicine - Clinical Terms SOAP: Subjective, Objective, Assessment, Plan TM: Translation Memories WAN: Wide Area Network WBAN: Wireless Body Area Network WHO: World Health Organization WS: Web Services WSD: Word Sense Disambiguation

HEALTH-DISEASE PROCESS KNOWLEDGE REPRESENTATION The Problem of Clinical Knowledge Acquisition In the KR community of the AI science domain, recent developments are sprouting that lead to the establishment of expressive ontologies based in OWL2 as the foundation for distributed reasoning in complex domains in the Semantic Web (D. Mendes, Rodrigues, & Baeta, 2013). This approach has revealed a serious problem when trying to represent highly specialized and complex domains of science, namely the medical domain that is the “Knowledge Acquisition Bottleneck” (Wong et al., 2012). The ontology creation and development has traditionally been in charge of multidisciplinary domain experts

722

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

that have to master both their particular scientific field and the ontology engineering novel techniques. These experts are very few and they are normally engaged in defining the ontological terminological structures of their domain ontologies, the TBox, and cannot be worried with the ABox to enrich the ontologies into KBs that can be automatically reasoned upon.

The Possible Solutions The diverse solutions that appeared in the literature involve some form of automated acquisition trying to relieve the Domain Experts from the heavy burden. This is not obvious how to accomplish. We evaluated literature from the early (Studer, Fensel, Decker, & Benjamins, 1999) to the current methodological review (Zouaq & Nkambou, 2010) that focuses particularly on automatic methods for ontology learning from texts as they summarize the state of the art in natural language processing techniques, statistical and machine learning techniques for ontology extraction. The current methodologies are focused on the paradigm of domain modeling. They shift the workload for the domain experts, from the direct acquisition to the modeling, but fail to realize that a feasible solution lies in a two-step approach like ours. In our case we have a machine learning phase to tutor the model from some source reports, and then use the Gold Standard, partially enriched ontology, to trigger the automatic ontology learning from the full set of texts that represent the reasoning domain (D. Mendes et al., 2013).

Our Solution To be able to use the reasoning techniques and methodologies that represent the state-of-the-art in the Artificial Intelligence domain we made a thorough inventory of biomedical ontologies currently available in OWL2 format. It was found that no solution for complete Clinical Practice representation is available with enough expressiveness in its foundation for exact clinical reasoning, and we introduced the OGCP presented in the next section (D. J. M. Mendes, Rodrigues, Baeta, & Solano-Rodriguez, 2015). Formal ontologies make the semantics of terms and relations explicit such that automated reasoning can be used to verify the consistency of knowledge. To express the richness of medical knowledge without any loss of intending meaning, a broad set of ontological relations, only expressible in OWL2 using role-chains, for instance, have to be part of our TBox and it will have a SHOIN DL. While this level of representational capability is compulsory for clinical reasoning there is also an important constraint relating to the usability of our ontology that is the need to have a near real-time classification complexity because it has to be very responsive in the interactive sessions that the doctors will use when using natural language questioning. We have to use pragmatic solutions to these real constraints and OGCP is formed of a dual capability because the ABox only possesses EL++ DL expressiveness. We use the ELK (Kazakov, Krötzsch, & Simančík, 2013) consequence based reasoner that has polynomial time response to classify on-the-fly the CNL assertions introduced interactively by the users. Our pragmatic approach rests on the evidence that to overcome the KAB the tools available to the public, in general, have to be supportive in nature like: • • •

Being based on natural language interaction, Responsive in order to be accepted by the clinical community as a working tool, and Scientifically extremely accurate and self-evident because not even the slightest chance of error is acceptable in the medical domain and especially in healthcare.

723

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

Moreover, we accept as evidence that natural language is the Lingua Franca for communication among physicians, and we have to gather information in computable form from text that they traditionally use to pass their information. Thus, we can conform the scope of our work in: 1. Develop an Ontology suitable to model the healthcare processes accurately. 2. Develop a process for automatic acquisition of the ontology ABox from text. 3. Use this framework as support for natural language CQA to be used as an AI professional aid.

OGCP Ontology Taking into account the considerations introduced in (Meystre, Savova, Kipper-Schuler, & Hurdle, 2008; Spasic, Ananiadou, McNaught, & Kumar, 2005) and more recently illuminated by the developments in technology and tooling as referred in (I. Yoo et al., 2012) we directed our efforts to finding the adequate ontology that does not fall short in particular issues of different medical specialties. To accomplish a successful work the resulting ontologies have to attain the sort of user-friendliness, reliability, costeffectiveness, and breadth of coverage that is necessary to ensure extensive usage as introduced by (B Smith & Brochhausen, 2010). Considering that the amount of Clinical data digitally preserved in natural language texts is colossal and ever increasing, numerous problems have to be solved as reviewed by (Liu, Hogan, & Crowley, 2011; Meystre et al., 2008). Most of the clinical data is in text form coming either from typing entry, transcription from dictation or speech recognition applications. Accurate coding is necessary for comparability, auditability and last but not least important, accountability. We intend to figure out a “picture of Healthcare provisioning” through clear identification of the meaning of the available data and not only by the capability of cataloging and codifying that huge amount of data. Ultimately none of the currently existing proposed ontology structures is appropriate for clinical practice knowledge representation and we introduce OGCP. The ontology alignment in our OGCP is not an issue as it results of the hard labor of the OBO Foundry (Courtot, Mungall, Brinkman, & Ruttenberg, 2011) that has established inter-operable biomedical ontologies since the advent of the Gene Ontology that dates back to 2001. All their work has been supported by the Ontological Realism philosophical principles since 2007 (Barry Smith et al., 2007). We adopt the SNOMED-CT CORE subset as terminological source due to its full coverage, acceptance and applicability to our specific case. We explored thoroughly the CPR ontology (Ogbuji, 2011) and found it to be an adequate framework for full breadth coverage of the clinical practice but was lacking, however, the ontological relations needed to enforce any model of disease. CPR can be seen as an extensible framework to be heavily structured further by any suitable modeling upper ontologies like those that the OBO Foundry mandates. With the CPR as a healthcare provisioning representation support we still had to enforce any existing model for medical science, and we had the OGMS complemented with the DO to do so as a general practice model. We have developed a full workflow to extract the “clinical process automatically” from SOAP reports. IE typically requires some “pre-processing” such as spell checking, document structure analysis, sentence splitting, tokenization, WSD, part-of-speech tagging, and some form of parsing namely for identification of strings representing quantities or abbreviations, as in laboratory results, for instance. The telegraphic form that is common to clinicians also poses some constraints to the usual NLP techniques used in other fields. We used this to our advantage tutoring a controlled translation to enforce GS TM that enables the subsequent automatic acquisition from the widely available text notes thus surpassing the KAB problem.

724

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

Figure 1. Ontological structure of OGCP

SOAP Reports The SOAP note was first conceived by Dr. Lawrence Weed, MD in the 1970s, under the acronym Problem Oriented Medical Record (POMR). At the time, there was not an objective method of documentation, which led to physicians making unscientific decisions about patient treatment. SOAP notes gave physicians rigor, structure, and a way for practices to communicate with each other. In the early 1970s, the adopters of SOAP notes were able to retrieve all patient records for a given medical problem. Before Electronic Medical Record (EMR) software, providers had trouble accessing needed charts. Before standardized SOAP notes, providers communicated with each other in unstructured formats, leaving patient care up to a great chance. A SOAP note is a documentation method employed by healthcare providers to create patient’s chart. There are four parts of a SOAP note: Subjective, Objective, Assessment, and Plan: •

•

Subjective: Describes the patient’s current condition in narrative form. This section usually includes the patient’s chief complaint, or reason they came to the physician. It is normally the place for the symptoms brought in by the patient and includes: ◦◦ Onset (when and mechanism of injury if applicable), ◦◦ Chronology (better or worse since onset, episodic, variable, constant, etc.), ◦◦ Quality (sharp, dull, etc.), ◦◦ Severity (usually a pain rating), ◦◦ Modifying factors (what aggravates/reduces the complaint activities, postures, drugs, etc.), ◦◦ Additional symptoms (un/related or significant symptoms of the chief complaint), and ◦◦ Treatment (has the patient seen another provider for this symptom?). Objective: Documents objective, repeatable, and traceable facts about the patient’s status. Associated with signs including: ◦◦ Vital signs,

725

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

• •

◦◦ Findings from physical examinations, such as posture, bruising, and abnormalities, ◦◦ Results from laboratory, and ◦◦ Measurements, such as age and weight of the patient. Assessment: The Physicians medical diagnoses for the medical visit on the given date of a written note. Plan: This describes what the health care provider will do to treat the patient, ordering labs, referrals, procedures performed, medications prescribed, etc.

This clinically oriented structuring is well known and widely accepted in the healthcare community, and text sources based on it are generally available. Many EHR systems provide a software module to create them. It represented an opportunity for our work developing a methodology to enrich our ontology from such an important source.

Tutoring Process The first step in developing the automatic acquisition is a preparation process where the system is taught using some similar SOAP texts on how to properly identify and classify all the different segments. This preliminary phase needs to be done for every clinical reality that is to be subjected afterward of KB creation, for a specific doctor, a given service, a period or anything intended. For this preliminary step to be accomplished, we took inspiration for the supervised training in the development of a GS clinical annotated corpus presented in (Roberts et al., 2009). In fact, the set of the resulting TM obtained can be seen as a GS for the accurate clinical term identification. The process can be pictured like this: The learning process is based on the refinement of the Translation Memory(ies) (TM) applied to that specific acquisition. It can be seen as a “manual translation tutoring” although the focal point is not really the translation from different “natural languages” to English but, in fact, from the original controlled technical jargon to “specialized English”. After the tutoring incremental process, the found acronyms, named entities, and clinical terms are ready to be adequately tagged in the process presented ahead in the next section for the correct Ontology Driven (OD) annotation. Figure 2. Supervised translation memory(ies) (TM) training

726

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

The Automatic ABox Population Task After using a relatively small, although representative, set of training SOAP reports the automatic process for the elicitation of the clinical reality represented by assertion facts into a fully enriched KB is possible and very effective. This high quality level is perceived by the users when interactively interrogating and enhancing the ontology but also by the preliminarily indicative, very good indices of recall, precision and F-Measure that are currently undergoing the process of comparative testing. The novel scientific advance that enables these promising results is the dual DL expressiveness of our OGCP based KB. The ABox of the KB is EL++ which is very effective computationally both in the acquisition and the classification processes. Before entering the explanation of the pipeline proposed for automatic acquisition from texts the used tools and methodologies have to be presented. Both the Attempto Controlled English (ACE) set of CNL tools and Protégé views accessible through the ACE view plugin and the bag of Apache ecosystem of tools for NLP are used in this work. ACE is a precisely defined subset of English that can automatically and unambiguously be translated into FOL. Thus, it is both human and machine understandable. Teaching the construction and interpretation rules takes about two days (N. E. Fuchs & Schneider, 2006). ACE appears perfectly natural, but it is, in fact, a formal language. ACE texts are computer-processable and can be unambiguously translated into DRS. DRS derived from ACE texts have been translated into various other languages, for instance into FOL and for stable model semantics. The Attempto project (Kaljurand & Fuchs, 2007) developed a bidirectional translation of ACE into and from OWL2. This tool can be used whether locally, via the Protégé plugin, via a WS or through a Web Interface. We have been using it extensively through its various incarnations in our ontology modeling efforts. In concrete terms we used the ACE Plugin to derive all the inferable consequence rules for the TBox of our OGCP ontology in order for the posterior usability of the consequence driven reasoner ELK that operates over the less expressive acquired EL++ ABox. We take advantage of the semi-structure of the SOAP reports to perform the population of the leafnodes of the KB with ontologically rich nodes. Clinical concept acquisition encompasses, in our view, the application of the notion of non-taxonomic roles extraction, which is ontological relations, from the sources. This theme has been extensively discussed in literature. Without non-taxonomic roles, ontology generation boils down to generating taxonomies that miss a lot of crucial semantic information compared to ontologies (Petrova et al., 2015), so we retrieve the ontological relations using this novel mechanism. DR is built by the ACE Parser according to all the learned cases, the ABox, and using the OGCP KB available to build “on-the-fly” the Clinical Integrated Discourse Extended Representation Structure (CIDERS).

Interactive Extended DRS Aware Enrichment Through CQA All the possible consequences inferable from our base OGCP ontology, without any assertions included yet, are already incorporated because we used the mainstream Pellet or Hermit reasoners to develop all the consequence rules. This was a necessity for the ELK reasoner to have all the rules already “at hand” in order to expand only those EL facts collected in the ABox without compromising the scientific foundation of clinical reasoning. When using the, more than enough, SNOMED-CT CORE subset of clinical terms, full classification of the KB is done is some seconds and all the consequences were previously expanded so that the ELK reasoner only classifies the ABox when interactively the clinician poses CNL

727

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

Figure 3. Knowledge base (KB) enrichment through interrogation

questions. The answers are then provided in acceptable negligible time delays in commodity laptops. We wrap-up here some achieved controlled results. Q: What is the patient’s personal history? A: Hypertension for 15 years; Diabetes Mellitus type 2 for ten years; Cholecystectomy 2 years ago; Diabetic father; Obese BMI 26,5; Abdominal perimeter 106 cm. This is a direct expression of the entailment of having several PH entries. The OWL verbalizer just tries to present the best possible, with higher usage evaluation in the trained expression in the time framing of the represented events in the OWL-Time properties related to that patient. Q: What is the suggested diagnosis? A: Laboratory routines: lipid profile; HgA1c; Rx thorax; ECG in rest; Echocardiogram; Effort test (Effort proof or Cardiac scintigraphy); Suggested diagnosis triggers the mark words Suggested and diagnosis. With Suggested, ELK rules are automatically generated that try to satisfy the set of inferences that are consistent with the KB for every patient that has the same, or non-contradictory set of conditions modeled by CVDO on top of OGMS. Diagnoses suggested then are all those already part of the historical practice (ABox Clinical Integrated Discourse Extended Representation Structure (CIDERS)) or enforced by the underlying ontological framework. The verbalizer then proceeds as in the previous example. Q: What is the immediately recommended therapy assuming that AHT and Diabetes are not controlled? A: Rich fiber and vegetable diet; polifraccionate and hiposaline; IECA or ARA II; Calcium Antagonist; Metformine; Estatine; Here we have the most challenging inferencing situation. The sole generation of hypothesis based on the set of assertional EL++ facts is not enough to sustain the question any longer. Rules generated in this situation explore the additional VNN ¬controlled(Diabetes) and ¬controlled (AHT) to trigger

728

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

further rules in order to generate all the consequences consistent with the new negated hypotheses (that have to be syntactically pre-processed). These are, of course, highly controlled results that are only possible, so far, under the interactive set of Protégé and the set of plugins detailed above.

CIDERS The ACE web service that we use to automatically generate the DRS is fed with the extended scope conformed by the “OWLification” of the subsequent texts acquired, so far. All the acquired texts represent the known clinical history. The DRS forming abilities of the Web Service explained in (N. E. E. Fuchs, Kaljurand, & Kuhn, 2008) are thus enhanced to consider all the texts for word sense and discourse disambiguation, ellipsis and anaphora resolution, The domain of discourse gets narrower as more and more texts are fed to the ontology ABox, and this renders the DRS more accurate as the ontology is enriched with more detailed clinical historical facts. CIDERS can then be considered as an OWL clinical history that can be verbalized. This verbalization and OWL formalization functions as a discourse controller for Question/Answering enrichment and Clinical Decision Support System processes.

IoT TO THE RESCUE FOR INTELLIGENT LIFE EVENT ACQUISITION Using the IoT in the Healthcare Process The Internet of Things (IoT) is finding its most promising field of application in the development of AAL tools (Atzori, Iera, & Morabito, 2010). It is becoming gradually evident that the assistance needs for older adults have to rely upon automatization technologies to assist traditional human caregivers. These emerging widespread technologies available in “Smart Homes” can in fact enable less differentiated caregivers to provide assisted help. Hetero caregivers (formal and informal), if supported by technology can deliver better assistance if duly directed by evidence based AI tooling. This capability is especially evident in the vulgar case of multi-morbidity which is the most common situation amongst aging adults. The interactions of diverse drugs, therapies and other caregiving details that arise when co-morbidities are present, can be handled in an integrated form if a computer based Intelligent Healthcare Supervisor is monitoring and acting in the living environment. This assisted living environment comprises a multitier area network consisting of Body Area Network (BAN), the LAN and ultimately the WAN. In our case we suggest the usage of a highly secure hybrid cloud for the Docker/Container based virtualization to provide the needed distributed persistence where the reasoning is to be based upon. The reasoning capabilities, tightly related to the scope of the clinical knowledge (automatically) reflected upon, range from very severe alarms that trigger rules in the BAN like a heart failure, for instance, to evidence based reasoning available in a supercomputing framework that can reason over the overall clinical history and living conditions acquired that trigger highly sophisticated caregiving suggestions.

729

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

Event Acquisition in Assisted Living Environments As seen in the previous section, our proposed systems possess the capability of reasoning about the health/disease process of a person due to the CIDERS representation acquired. This clinical history can be reasoned upon and continuously enhanced through the monitoring of the daily events and activities. To implement a controlled living environment, the usual approach is to augment a home with various types of sensors and actuators. These Smart Homes gather knowledge in order to provide comfort for the residents but can be used as well to assess the cognitive and physical health of those residents. Both the living conditions and the bodily signs and symptoms need to be controlled.

Sensor Enabling the Person and the Environment Sensors are tending to be non-intrusive wearable and mobile. Most prominent emerging technologies range from MEMS to epidermal electronics that enable new health related sensors. Non-invasive sensors in form of patches, small holter-type and body worn devices as well as smart garments monitor health signals. Blood glucose and pressure as well as cardiac activity can be measured using wearables that use infrared, optical and oscillometric sensing. Table 1 summarizes typical wearable and mobile sensors (Memon, Wagner, Pedersen, Beevi, & Hansen, 2014): WBANs enable wireless communication around a human body. Several technologies have been proposed to achieve energy efficient communication including (Ylisaukko-oja, Vildjiounatie, & Mantyjarvi, 2004) or (H.-J. Yoo & Bae, 2013). More recently, using the body tissue as transmission medium is being proposed. From the foundational thesis by Wegmüller (Wegmüller, 2007) to the more recent works like (Bae, Cho, Song, Lee, & Yoo, 2012; Vallejo, Recas, del Valle, & Ayala, 2013). Table 1. Wearable and mobile sensors Sensor

Measurement

Data Rate

Accelerometer

Acceleration

High

Gyroscope

Orientation

High

Glucometer

Blood Glucose

High

Pressure

Blood Pressure

Low

CO2

Respiration

Very Low

ECG (Electrocardiography)

Cardiac Activity

High

EEG (Electroencephalography)

Brain Activity

High

EMG (Electromyography)

Muscle Activity

Very High

EOG (Electrooculography)

Eye Movement

Very High

Pulse Oximeter

Blood Oxygen Saturation

Low

GSR (Galvanic Skin Response)

Perspiration

Very Low

Thermal

Body Temperature

Very Low

Civet Fluximeter

Urine Flow

Very Low

730

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

The amount and quality of continuous monitoring data is getting to paramount levels to what is duly considered Big Data and has to be handled as such. The huge data gathering can be pictured as an upward flow from the BAN to the WAN according to the architecture suggested in the beginning of this section. Caregiving rules activation represent the opposite flow of data/information/knowledge in a downward direction.

Healthcare Process Activation Ruling For the upward flow of knowledge, a minimal set of information is collected to generate axioms in the Functionality Ontology (OF) developed to model the WHO International Classification of Functionality (ICF) (WHO, 2001). This information set on the inabilities to accomplish everyday living chores generates, when verified in relation with the healthcare process knowledge, the latest scientific evidence and the actual case based living conditions, the advising for the least differentiated caregiver. As an example we usually use the simple reminder of an automatic phone call to the informal caregiver that some medication has to be taken at a certain hour. Also a record of the therapeutic adherence is maintained in the extended healthcare process in an effort to strengthen this adherence in the aged population.

From Smart Homes to Intelligent Homes Apart from providing the connected reality to the physical world of the old person, the Smart Home is now able to provide counseling and support for the healthcare activities that have to be part of the daily lives of the elder. This is made through natural interfaces that expand the Smart Phone personalities into a truly health assistant. Different issues and obstacles to ICT adherence for elder people are addressed in literature from preliminary works (Loader, Hardey, & Keeble, 2008), going through important developments (Cocosila & Archer, 2010; Haux, Howe, Marschollek, Plischke, & Wolf, 2008) and policy conforming documents in the European reality (European Union, 2010) redounding in more recent overviews Figure 4. Knowledge flow in intelligent assisted living

731

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

of the problem (Erden, Velipasalar, Alkar, & Cetin, 2016; Heart & Kalderon, 2013; Kozar-Westman, Troutman-Jordan, & Nies, 2013; Li, Lu, & McDonald-Maier, 2015; Memon et al., 2014; Mowafey & Gardner, 2013; Rashidi & Mihailidis, 2013). In our work developments we take in consideration the myriad of issues when developing natural interfaces directed to the diverse caregivers ranging from the auto-care to specialized professional teams. The domiciliation of care renders huge savings as has been already demonstrated (Fillmore, DuBard, Ritter, & Jackson, 2014) while, simultaneously, improves the perceived quality of care and raises globally the health indicators. This is all made possible by Healthcare Intelligent Homes that can contribute to resolve the chronically ill society that we live in.

CONCLUSION We presented our proposal for an extended Discourse Representation Structure that is part of a knowledge representation infrastructure directed to QA interactive clinical decision support systems. These systems are enabling the usage of highly optimized distributed consequence based reasoners that were referred in the literature only in 2011. With these very recent developments it is possible to validate a controlled size knowledge base that is created by automatically populating a proposed ontology that relies on extensive, and very solid, foundations like SNOMED-CT and FMA among other OBO Foundry ontologies. We demonstrate a solid approach to overcoming the “Knowledge acquisition Bottleneck” by using an automated acquisition of very tractable KB directly from clinical text reports based on the wellknown SOAP methodology. Dividing the KB between an expressive foundation (SHOIN) that relies on the coordination of OBO foundry ontologies and a less expressive but highly effective in computational characteristics (EL++) ABox we render a knowledge infrastructure with very interesting properties for CP representation and reasoning. We introduce natural language clinical reasoning aids that are based on such breakthrough techniques. We also show how to maintain the size of the OGCP ontology very limited in order to be able to apply these innovative AI advances and techniques in commodity hardware. Logical inferencing and clinical facts entailment that are possible through this novel capability is an interesting contribution to the application of AI to healthcare. We these tools at hand we delve into the field of Intelligent Ambient Assisted Living fueled by the IoT and raise the veil in our proposal for homes that can contribute significantly to a new wave of caregiving facilities that provide better quality of life for our elder population.

ACKNOWLEDGMENT Acknowledgments are to be issued to DECSIS and Universidade de Évora that funded this project works.

732

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

REFERENCES Atzori, L., Iera, A., & Morabito, G. (2010). The Internet of Things: A survey. Computer Networks, 54(15), 2787–2805. doi:10.1016/j.comnet.2010.05.010 Bae, J., Cho, H., Song, K., Lee, H., & Yoo, H. J. (2012). The signal transmission mechanism on the surface of human body for body channel communication. IEEE Transactions on Microwave Theory and Techniques, 60(3), 582–593. doi:10.1109/TMTT.2011.2178857 Cocosila, M., & Archer, N. (2010). Adoption of mobile ICT for health promotion: An empirical investigation. Electronic Markets, 20(3-4), 241–250. doi:10.100712525-010-0042-y Courtot, M., Mungall, C., Brinkman, R. R., & Ruttenberg, A. (2011). Building the OBO foundry - One policy at a time. In CEUR Workshop Proceedings (Vol. 833, pp. 377–380). Erden, F., Velipasalar, S., Alkar, A. Z., & Cetin, A. E. (2016). Sensors in Assisted Living. Retrieved May 30, 2016, from https://www.researchgate.net/profile/Fatih_Erden2/publication/297659778_Sensors_in_Assisted_Living_A_survey_of_signal_and_image_processing_methods/links/56e18f9508ae40dc0abf5111. pdf European Union. (2010). ICT & Ageing-European study on users, markets and technologies. European Commission. Retrieved from http://scholar.google.com/scholar?hl=en&btnG=Search&q=intitle:ICT +&+Ageing+European+Study+on+Users+,+Markets+and+Technologies+Final+Report#0\nhttp:// scholar.google.com/scholar?hl=en&btnG=Search&q=intitle:ICT+&+Ageing-European+Study+on+ Users,+Markets+and+T Fillmore, H., DuBard, C. A., Ritter, G. A., & Jackson, C. T. (2014). Health care savings with the patientcentered medical home: Community Care of North Carolina’s experience. Population Health Management, 17(3), 141–148. doi:10.1089/pop.2013.0055 PMID:24053757 Fuchs, N. E., & Schneider, G. (2006). Attempto Controlled English Meets the Challenges of Knowledge Representation, Reasoning, Interoperability and User Interfaces. American Association for Artificial Intelligence. Fuchs, N. E. E., Kaljurand, K., & Kuhn, T. (2008). Discourse representation structures for ace 6.0. Department of Informatics, University of Zurich. Retrieved from http://citeseerx.ist.psu.edu/viewdoc/ download?doi=10.1.1.148.6989&rep=rep1&type=pdf Haux, R., Howe, J., Marschollek, M., Plischke, M., & Wolf, K. (2008). Health-enabling technologies for pervasive health care: On services and ICT architecture paradigms. Informatics for Health & Social Care, 33(2), 77–89. doi:10.1080/17538150802127140 PMID:18604752 Heart, T., & Kalderon, E. (2013). Older adults: Are they ready to adopt health-related ICT? International Journal of Medical Informatics, 82(11), e209–e231. doi:10.1016/j.ijmedinf.2011.03.002 PMID:21481631 Kaljurand, K., & Fuchs, N. E. (2007). Verbalizing OWL in Attempto Controlled English (Vol. 258). OWLED.

733

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

Kazakov, Y., Krötzsch, M. R., & Simančík, F. (2013). The Incredible ELK. Journal of Automated Reasoning, 53(1), 1–61. doi:10.100710817-013-9296-3 Kozar-Westman, M., Troutman-Jordan, M., & Nies, M. A. (2013). Successful aging among assisted living community older adults. Journal of Nursing Scholarship, 45(3), 238–46. http://doi.org/10.1111/jnu.12027 Li, R., Lu, B., & McDonald-Maier, K. D. (2015). Cognitive assisted living ambient system: A survey. Digital Communications and Networks, 1(4), 229–252. doi:10.1016/j.dcan.2015.10.003 Liu, K., Hogan, W. R., & Crowley, R. S. (2011). Natural Language Processing methods and systems for biomedical ontology learning. Journal of Biomedical Informatics, 44(1), 163–179. doi:10.1016/j. jbi.2010.07.006 PMID:20647054 Loader, B. D., Hardey, M., & Keeble, L. (2008). Health informatics for older people: A review of ICT facilitated integrated care for older people. International Journal of Social Welfare, 17(1), 46–53. doi:10.1111/j.1468-2397.2007.00489.x Memon, M., Wagner, S., Pedersen, C., Beevi, F., & Hansen, F. (2014). Ambient Assisted Living Healthcare Frameworks, Platforms, Standards, and Quality Attributes. Sensors (Basel, Switzerland), 14(3), 4312–4341. doi:10.3390140304312 PMID:24599192 Mendes, D., Rodrigues, I. P., & Baeta, C. F. (2013). Enrichment/Population of customized CPR (Computerbased Patient Record) ontology from free-text reports for CSI (Computer Semantic Interoperability). International Journal of E-Health and Medical Communications. Retrieved from http://www.ejhi.net/ ojs/index.php/ejhi/article/view/194 Mendes, D. J. M., Rodrigues, I. P., Baeta, C. F., & Solano-Rodriguez, C. (2015). Extended Clinical Discourse Representation Structure for Controlled Natural Language Clinical Decision Support Systems. International Journal of Reliable and Quality E-Healthcare, 4(2), 1–11. doi:10.4018/IJRQEH.2015040101 Meystre, S. M., Savova, G. K., Kipper-Schuler, K. C., & Hurdle, J. F. (2008). Extracting information from textual documents in the electronic health record: A review of recent research. Yearbook of Medical Informatics, 128–144. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/18660887 PMID:18660887 Mowafey, S., & Gardner, S. (2013). Towards ambient intelligence in assisted living: The creation of an Intelligent Home Care. Science and Information Conference. Retrieved from http://ieeexplore.ieee.org/ xpls/abs_all.jsp?arnumber=6661717 Ogbuji, C. (2011). A Framework Ontology for Computer-Based Patient Record Systems. In Proceedings of the ICBO: International Conference on Biomedical Ontology (pp. 217–223). Petrova, A., Ma, Y., Tsatsaronis, G., Kissa, M., Distel, F., Baader, F., & Schroeder, M. (2015). Formalizing biomedical concepts from textual definitions. Journal of Biomedical Semantics, 6(1), 22. doi:10.118613326-015-0015-3 PMID:25949785 Rashidi, P., & Mihailidis, A. (2013). A Survey on Ambient-Assisted Living Tools for Older Adults. IEEE Journal of Biomedical and Health Informatics, 17(3), 579–590. doi:10.1109/JBHI.2012.2234129 PMID:24592460

734

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

Roberts, A., Gaizauskas, R., Hepple, M., Demetriou, G., Guo, Y., Roberts, I., & Setzer, A. (2009). Building a semantically annotated corpus of clinical texts. Journal of Biomedical Informatics, 42(5), 950–966. doi:10.1016/j.jbi.2008.12.013 PMID:19535011 Smith, B., Ashburner, M., Rosse, C., Bard, J., Bug, W., Ceusters, W., ... Lewis, S. (2007). The OBO Foundry: Coordinated evolution of ontologies to support biomedical data integration. Nature Biotechnology, 25(11), 1251–1255. doi:10.1038/nbt1346 PMID:17989687 Smith, B., & Brochhausen, M. (2010). Putting Biomedical Ontologies to Work. Methods of Information in Medicine, 49(2), 135–140. doi:10.3414/ME9302 PMID:20135080 Spasic, I., Ananiadou, S., McNaught, J., & Kumar, A. (2005). Text mining and ontologies in biomedicine: Making sense of raw text. Briefings in Bioinformatics, 6(3), 239–251. doi:10.1093/bib/6.3.239 PMID:16212772 Studer, R., Fensel, D., Decker, S., & Benjamins, V. R. (1999). Knowledge engineering: Survey and future directions. Lecture Notes in Computer Science, 1570, 1–23. http://doi.org/ doi:10.1007/10703016_1 Vallejo, M., Recas, J., del Valle, P. G., & Ayala, J. (2013). Accurate human tissue characterization for energy-efficient wireless on-body communications. Sensors (Basel, Switzerland), 13(6), 7546–7569. doi:10.3390130607546 PMID:23752565 Wegmüller, M. S. (2007). Intra-Body Communication for Biomedical Sensor Networks. ETH, (17323). http://doi.org/10.3929/ethz-a-005479240 WHO. (2001). The International Classification of Functioning. Disability and Health. World Health Organization, 18, 237. doi:10.1097/01.pep.0000245823.21888.71 Wong, W., Liu, W., & Bennamoun, M. (2012). Ontology learning from text: A look back and into the future. ACM Comput. Surv., 44(4), 20:1–20:36. http://doi.org/10.1145/2333112.2333115 Ylisaukko-oja, A., Vildjiounatie, E., & Mantyjarvi, J. (2004). Five-Point Acceleration Sensing Wireless Body Area Network - Design and Practical Experiences. Eighth International Symposium on Wearable Computers. 10.1109/ISWC.2004.22 Yoo, H.-J., & Bae, J. (2013). Low energy wireless body area network systems. In Wireless Symposium (IWS), 2013 IEEE International (pp. 1–2). http://doi.org/10.1109/IEEE-IWS.2013.6616846 Yoo, I., Alafaireet, P., Marinov, M., Pena-Hernandez, K., Gopidi, R., Chang, J. F., & Hua, L. (2012). Data Mining in Healthcare and Biomedicine: A Survey of the Literature. Journal of Medical Systems, 1–18. PMID:21537851 Zouaq, A., & Nkambou, R. (2010). A Survey of Domain Ontology Engineering: Methods and Tools. Advances in Intelligent Tutoring Systems, 103–119. http://doi.org/10.1007/978-3-642-14363-2_6

735

 Healthcare Computer Reasoning Addressing Chronically Ill Societies Using IoT

KEY TERMS AND DEFINITIONS CIDERS: A knowledge representation of the health-disease process that is acquired from text based sources of the clinical history. Clinical Question Answering: The utilization of progressively more complex clinical questions posing by the users to assist in the deep learning question answering by the computer systems. Deep Learning: Using an ontology framework for computer systems to be able of reasoning with the exact semantic meaning of the general available knowledge. Health-Disease Process: The lifetime span of the health process that is subjected to care by the self, informal caregivers or formal health and emergency professionals. Least Differentiated Caregiver: When applying the scalable model of caregiving based on the International Classification of Functionality emerges the possibility of pinpointing the exact caregiver for any given health event or need that can deliver the adequate response with the lower cost associated. Wireless Body Area Network: The utilization of virtually noninvasive sensors to collect and monitor numerous health related signals and deliver them through a gateway to higher levels of knowledge aware reasoning systems.

This research was previously published in Design, Development, and Integration of Reliable Electronic Healthcare Platforms edited by Anastasius Moumtzoglou, pages 32-48, copyright year 2017 by Medical Information Science Reference (an imprint of IGI Global).

736

737

Chapter 37

Commercial Home Assistance Services Milica Milutinovic K.U.Leuven, Belgium Koen Decroix Katholieke Hogeschool Sint – Lieven, Belgium Vincent Naessens Katholieke Hogeschool Sint – Lieven, Belgium Bart De Decker K.U.Leuven, Belgium

ABSTRACT In this chapter, the authors describe the software architecture of a commercially run home assistance system that allows patients or elderly people to stay longer at home. Since such systems often have to handle sensitive medical information, the protection of the privacy is a major concern. In addition, legislation often restricts access to health information to qualified persons (i.e. medical personnel), who are not always available in a commercial setting. The home assistance system can offer several services, ranging from scheduling necessary tasks and following up their execution, to monitoring the patient’s health status and responding promptly to requests for help or in case of emergency situations, and all this without the need to maintain personal medical data or identifying information about patients and caregivers in the home assistance centre.

INTRODUCTION The average life expectancy in the Western world has risen well above 80 years. Also, the limited birth rate has resulted in a greying population and caused the population pyramid to flip upside down or at least to become more cube-like. The progress of medicine has made many diseases and disorders curable or at least less life threatening. However, the downside of this evolution is that the government’s social security budget needs to expand year after year and may grow faster than the country’s economic DOI: 10.4018/978-1-5225-7122-3.ch037

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Commercial Home Assistance Services

growth. One way to cut costs is to have elderly people stay at their homes much longer instead of moving them to nursing homes and dismiss patients sooner from hospitals. However, these elderly people or patients often need extra care or have to be monitored from time to time or continuously. Luckily, technology can fulfil these needs. For more than a decade, elderly people can get help to stay longer at home. In the morning, a nurse, often employed by a nursing organization or self-employed, visits the old person, helps him to get out of bed and to get dressed, administers medication and checks his health status. Later, a cleaning woman may arrive to keep the house tidy and clean. At noon, someone from a catering service may bring an appropriate lunch. In the afternoon, family members, neighbours or volunteers may pay him a short visit and do some necessary shopping. In the evening, a nurse may help the old person get prepared for the night. Weekly, the general practitioner (GP) visits the old person, examines him and assesses whether it remains sensible to keep him at home. Sometimes, an orderly working for a specialized patient transport company collects the patient and brings him to the hospital for additional tests or a specialized treatment. Some weak old persons even get a special fall detector that calls an emergency number as soon as a fall is detected. This works fine as long as someone of the family or a close friend organizes the network of caregivers and schedules the different tasks. It remains difficult to quickly respond to last minute changes (e.g. someone cannot get there in time). Moreover, more and more elderly people do not have relatives who can take on this duty. Also, some people need more supervision and/or monitoring than the previous setting is capable of offering. There are many initiatives for designing and building such advanced home assistance centres. Often, hospitals are involved since they have skilled employees who are qualified to handle medical data and to make the correct assessments. However, hospitals are not the best players to run these home assistance centres. They often lack the technicians who are necessary to install and maintain the necessary equipment in the home environment. Moreover, these assistance centres should also offer support for non-medical services such as catering, cleaning, shopping, etc. These services are already provided by specialized organizations or companies. Hence, it is very likely that in the near future commercial businesses will start to operate home assistance centres. There is one important impediment for a commercial deployment, however. Many countries have legislations that limit the access to medical data to qualified personnel (e.g. doctors, paramedics, etc.). That means that if the home assistance centres (HACs) have to process medical data, they also need to employ medical personnel. Also, home assistance systems are by definition distributed systems (part of the system is deployed at the patient’s home and part at the centre) with many access points, which makes it much harder to restrict access to sensitive (medical or health) data. Therefore, the system should preferably be designed in such a way that HACs never see or process such data. Protecting the privacy of the elderly person or patient is of utmost importance. Even when the patient’s medical data is properly protected, information about the patient’s health could be indirectly inferred if one knows which specialist is treating the patient (e.g. when the doctor in attendance is an oncologist, one can easily deduce that the patient suffers from cancer). Therefore, not only the medical data needs to be protected, but also the patient’s network should remain hidden as much as possible. We have seen in the past many cases of accidental or deliberate leakage of privacy sensitive information; often because of the loss or theft of storage media or laptops. Hence, the system should avoid to store as much as possible identifying information about patients, doctors, etc. In the sequel of this chapter, we will no longer distinguish between patient and elderly person, and denote both by the term patient. 738

 Commercial Home Assistance Services

BACKGROUND Many research initiatives were bootstrapped during the last decades in the domain of remote health monitoring. Most research activities only cover part of the problem and results are typically applied in a three tier architecture which consists of a set of sensors, a base station and a health centre. At the sensor side, wireless sensor network protocols are embedded in health sensors. Many practical case studies aim at guaranteeing a minimal level of reliability and performance. For instance, Corchado (2010) proposed a remote system for health care that consists of heterogeneous wireless sensors. The system uses an optimized IDL to enable communication between low resource platforms. Jovanov et al. (2001) suggested to use a wireless PAN of intelligent sensors as a medical, monitoring system architecture. The network is organized hierarchically and individual sensors monitor specific physiological signals (such as EEG, ECG, GSR, etc.). Sarela et al. (2003) described a monitoring system for the elderly that provides alarm functionality. It consists of a wrist device detecting user induced alarms. Other research focuses on the development of gateways between sensors (or sensor networks) and service providers. For instance, MobiCare, proposed by Chakravorty (2006), implements a body sensor network manager (BSNM) on a mobile client. Its major task consists of aggregating data from sensors and forwarding them to a health centre or another predefined service provider. Korhonen et al. (2003) described a home server that offers services as OSGi bundles. This approach centralizes data processing and service provisioning in the home server. A similar architecture has been proposed for patient rehabilitation and video monitoring by Jovanov et al. (2005), emergency situations by Wood et al. (2008), etc. Those solutions often lack flexibility and reliability. It is difficult to ensure a service level if the base station crashes or if a service provider is not available. TeleCARE, proposed by Camarinha-matos (2002), is a more flexible agent-based approach for building virtual communities around elderly people. Agents migrate to the sensors and base station to offer services. The authors claim that security and privacy are important concerns but these are not really tackled in the approach. In other architectures, many tasks are performed at the care centre. For instance, in “A proposal for a home-based health monitoring system for the elderly or disabled” by Kim et al. (2006), coordination, data analysis and service provisioning are performed in a central monitoring station. Hence, the user has no substantial control on the services that are deployed and on the information that is released to the care centre. Therefore, very high trust is required in those care centres. Riedl et al. (2008) proposed an architecture for secure central storage of electronic health records (EHRs). The data are pseudonymized. Many research initiatives focus on privacy friendly storage of data. This chapter mainly focuses on enabling services based on technical means installed in the home environment of elderly people. However, anonymous storage technologies like those suggested by De Capitani di Vimercati et al. (2008) or Demuynck et al. (2005) can be added to our platform. Other research directions that are complementary to our contribution are interoperability initiatives. Kim, et al. (2010) demonstrated the possibility of interoperability between two standards, namely HL7 and IEEE 1451. HL7 is a messaging standard for exchanging medical information. IEEE 1451 deals with various aspects of sensors, the format of data sheets and how to connect and disconnect the sensors from a system. These standards can be used to exchange information between entities in our architecture. Multiple European initiatives also focus on remote e-health provisioning. epSOS (2008-2011) is European project for patient summary and electronic prescription that interconnect national solutions. It develops an e-health framework and ICT infrastructure that enables secure access to patient’s health data. In contrast to this project, our approach is more oriented towards health and care services. Mobi739

 Commercial Home Assistance Services

Health (2002-2004) developed an architecture for patient monitoring. The framework consists of a body area network with sensors that collects data from a patient. Data is sent along with video and audio via a cellular network (2.5G and 3G technology) to a healthcare centre. This raises major privacy concerns.

THE DESIGN OF A COMMERCIAL HOME ASSISTANCE SERVICE We will first briefly describe the system, including the functional requirements. Then, the security and privacy requirements are listed and the attacker’s model is presented. Next, the (anonymized) patient’s networks are described and the global architecture is depicted, followed by an overview of the protocols used by the system to protect the patients’ privacy. This section ends with an evaluation of the design.

Functional Description of the System The home assistance centre (HAC) offers different services which patients can subscribe to. All the services require that a base station is installed at the patient’s home (cfr Figure 1). It controls and manages the sensors (including the door system), assesses alert and emergency situations, gives advice, notifies caregivers (through the HAC), performs access control to medical data and enables communication Figure 1. The global architecture

740

 Commercial Home Assistance Services

between caregivers and the patient. The HAC will continuously monitor the correct working of the base station, and―in case of failure―send a technician within a contractually agreed time span. •

•

One service concerns the scheduling and following up of tasks that need to be performed by the caregivers of the patient’s network. Examples are cleaning the house, catering, nursing tasks in the morning/evening, help with administering medicines, shopping, visits or scheduled phone calls, etc. Scheduled phone calls are sometimes indispensable to help people suffering from a beginning dementia because they often become unaware of time. Phone calls at fixed times may remind them that it is time for breakfast, lunch, medication, etc. At any time, a patient can request new tasks to be performed or modify earlier ones. For every task, minimal skills may be required (e.g. medicines may only be injected by a paramedic or a doctor), a time frame within which the task should be performed may be defined, and a set of preferred or unwelcome caregivers may be suggested. Also, some caregivers should be able to schedule the tasks themselves because they are sent by organizations (e.g. nurses for nursing tasks) or because the caregiver is a professional that needs to attend several patients. The HAC will fairly assign the tasks to the different caregivers, taking their skills, availability and willingness to perform these tasks into account. Last minute changes (e.g. the caregiver cannot keep an appointment because she has been delayed by a traffic jam) must be considered and promptly a substitute should be appointed. The system also makes sure that the caregivers receive the proper means to enter the patient’s house (e.g. through timeconstrained access tokens that open the door without the need for a door key). As explained in the introduction, this service is often performed by the patient’s close relatives. However, since the number of single persons is growing, chances are that no family members are available to coordinate this service. Surveillance is another service patients can subscribe to. Different kinds of sensors and control units may be connected to the base station: ◦◦ Via a control stick with buttons, a patient can report an emergency, request help/advice or nullify an alarm; the stick can further be equipped with speaker and microphone to allow for a conversation between the patient and caregiver; ◦◦ A fall detector can discover a sudden fall; ◦◦ A heartbeat sensor may measure the heartbeat rate and detect arrhythmia; ◦◦ A pulse oximetry sensor can measure the oxygenation of the blood, etc.

The base station will collect the measurements and store them in the local database. Also, assessment tasks can process these measurements: compute averages, compare them with set thresholds, investigate their evolution, and possibly raise alerts. Note that some sensors may have processing capabilities and can perform assessment tasks themselves. Therefore, the base station must be capable to interface with both types: complex sensors, which need to be configured properly, and simple sensors, for which data collection and processing/assessment tasks need to be installed and executed on the base station. The patient treatment policy, which is usually composed by the patient’s GP or a specialist who is attending the patient, determines how these alerts will be handled: •

In some cases (‘mild alert’), the patient can be given advice (e.g. “take a seat and rest for a while” or “take a particular drug”, …); this advice can be accompanied by a movie, displayed on the base station or on a television set, in case of complex actions;

741

 Commercial Home Assistance Services

•

A caregiver should be informed about the patient’s current status (e.g. the GP gets a message each time the heartbeat rate exceeds a threshold; if that happens too often, the GP may pay the patient a visit); A caregiver should be notified that she needs to contact or attend the patient as soon as possible; The patient’s health status is critical and an emergency procedure should be started (e.g. an ambulance should be sent as soon as possible).

• •

Except for the mild alert, a dispatch centre, which is a part of the HAC, is informed and will take the appropriate measures (e.g. it selects the appropriate caregiver, sends her a text message and awaits a positive or negative response). In case of a negative or missing reply, another caregiver will be selected. If the HAC employs medical staff, a member of that staff could interact directly with the patient and assess the seriousness of the alert situation before a caregiver is notified. Note, however, that this kind of service could also be offered by a hospital or another medical institution. •

Privacy-protected social networks are yet another service offered by the HAC. These networks are meant to organize self-help groups. Self-help groups allow for exchanging information that may improve the patient’s comfort and living standard (e.g. hints about ‘how to do certain tasks’ or references to (new) drugs, treatments or specialists). Also, they may reduce the solitude of patients who do not see many visitors, by offering a listening ear of someone who is in the same situation. The major difference with existing social networks (e.g. Facebook, MySpace, etc.) is that only patients suffering from a particular illness and medical staff specialized in that area will be allowed to join that network. Also, members will only be known to each other by a pseudonym. Hence, the members’ privacy is protected and infiltrators (such as reporters, paparazzi or even greedy heirs) are kept out of the network. A final service is audit trails. The system guarantees that all important events and actions are securely logged and that these logs allow for a detailed, correct and proven reconstruction in case of a dispute.

•

•

The HAC also offers services to caregivers: •

• • •

742

Caregivers can maintain their (pseudonymous) profile on the system that lists their qualifications, willingness to perform certain tasks and their availability. These profiles are used to schedule the patient’s tasks. They can also notify the HAC when an assigned task cannot be accomplished (e.g. due to unforeseen circumstances); if necessary, the HAC will reschedule the task and find a replacement. Caregivers have remote access to the patient’s health information if they are authorized. Hence, they are able to accurately assess the patient’s health status without the need for a visit. Caregivers will be promptly notified when an emergency situation occurs. Hence, there is no need for regular phone calls (“Just to check whether everything is all right …”), and both the patient and the caregiver are guaranteed of timely notifications (i.e. no valuable time is lost). Caregivers who need to visit the patient will receive a time-constraint access token with which the door can be opened. Hence, unauthorized access to the patient’s home is prevented, while door keys do no longer need to be duplicated and distributed among the patient’s caregivers. This is important for caregivers who attend several patients and usually have to carry a ‘bag’ of keys.

 Commercial Home Assistance Services

•

Also, in case of last minute changes, a secure delegation procedure for these access tokens suffices to allow a substitute nurse to enter the house. Commercial companies (offering cleaning, catering, shopping, etc. services) and medical organizations (such as hospitals, rehabilitation centres, nursing organizations, etc.) may publish their services on the HAC system. By registering in the system, they can smoothly (and anonymously) be added to the patient’s network. These companies or institutions can either invoice the patient directly for used services or invoice the HAC which will subsequently charge the patient’s account.

Functional Requirements Based on the description in the previous section, we can deduce the following requirements: 1. The system should support scheduling of tasks: a. The system should be able to assign recurrent or one-time tasks to the members of the patient’s network and make up a schedule; b. The system should allow caregivers to maintain a profile which contains the caregivers’ qualifications, willingness to perform certain duties and availabilities; c. In addition, some members (e.g. organizations or professional caregivers) should be able to schedule the assigned tasks themselves; d. The system should be able to respond timely to last-minute changes (e.g. a caregiver that cannot keep an appointment and find a substitute or - in the worst case -notify the patient or a close relative or neighbour. 2. The system should support permanent monitoring of the patient: a. The patient needs a remote control unit to report emergency situations, to request for help or to nullify an alert; b. The system should be able to interface with all kinds of sensors (fall detector, heartbeat sensor, motion sensors, etc.); some sensors may be sophisticated and able to detect anomalies (e.g. exceeding a thresholds) and raise an alarm; others may merely measure body parameters and send these measurements at regular times to the system (in this case, the system should process the data and detect anomalies); c. The system should allow to start/stop/modify any number of assessment and/or processing tasks; these tasks could be run locally (at the patient’s home) or remotely (e.g. computation intensive tasks could be executed on the computers of a hospital); d. The system should be able to raise alerts and report emergencies and timely act accordingly: e.g. instructing the patient in applying first self-help, notifying the appropriate caregivers and/ or calling an ambulance, etc. 3. The system should provide sufficient communication means for interactions with the patient: a. A microphone and speaker should be available (possibly incorporated in the control unit) so that verbal communication is possible; it is often the first means to assess the gravity of an emergency situation or to calm down a patient in distress; b. The system should be able to show instructive movies (e.g. how to administer a medicine or how to use a device to measure a body parameter. For some measurements, patients may have to perform certain actions: e.g. pricking in one’s finger and having a drop of blood analysed by a blood glucose meter;

743

 Commercial Home Assistance Services

c. A chat function may be helpful in giving the patient clear and serial orders; d. A Webcam and a video call functionality may reduce the need for daily visits; they can help patients with beginning dementia who often suffer with their awareness of time, by synchronizing during important moments of a day (breakfast, lunch, dinner, etc.); they may help to detect early on emotional or psychic problems and, certainly, are a good means to avoid patients growing lonely; e. Video cameras installed in different rooms of the patient’s house allows for assessing what happened when the patient does no longer respond to stimuli from the system; f. All the above communication means should be easy to handle and should have a uniform, intuitive and simple interface. 4. The system should provide support for anonymous self-help groups. These groups resemble the social networks that are provided by popular network sites. However, they are only open to patients with a particular pathology and possibly medical staff specialized in that domain. The purpose of these groups is to exchange useful information among their members, to render assistance in nonacute matters, and to have a listening ear available during lonely or difficult moments. 5. The system should provide flexible access control to the patient’s home. Since many different caregivers need access to the patient’s home, an access mechanism based on physical keys is not desirable. Not only many copies of the same key are necessary, but they also give the bearer the possibility to enter the house at any time (i.e. they give the bearer too many privileges). Moreover, some services (such as nursing, catering, cleaning) are offered by organizations that may not always send the same caregiver to the patient; hence, physical keys must be passed on from one caregiver to the other, which is not always possible in case of a last minute change in the schedule. a. Therefore, virtual keys (or access tokens) are preferable. They allow for very fine-grained access control (e.g. the token issued to the catering service may only be used on weekdays between 11:30 and 13:00); b. For scheduled tasks or emergency situations, the system should be able to generate the necessary access tokens and deliver them securely to the appropriate caregiver or organization; c. The door access mechanism should provide for a flexible but controlled delegation mechanism in order to be able to deal with last minute changes.

Security and Privacy Requirements Health information and personal medical data are very privacy sensitive. Therefore, three requirements should be fulfilled: 1. Non-medical personnel should never get access to personal medical data; this requirement is necessary, since legislation in many countries imposes this rule; hence, strict access control must be provided; 2. The patient’s networks should be anonymized; this requirement is also important, since the knowledge of some of the caregivers of a patient’s network sometimes allows one to deduce the illness the patient suffers from. It will not be possible to hide everything, though. In general, one cannot hide that someone has health problems or needs permanent care, since passers-by may notice and recognize caregivers who enter or leave the patient’s house. However, the amount of deduced information should be limited. If someone gets hold of the database of the patients’ networks, because

744

 Commercial Home Assistance Services

of a deliberate leak by a disgruntled employee or a break-in into the system, he should not be able to learn privacy-sensitive information; 3. All logging information about what actions have been performed should be treated as extremely confidential. Except for a trusted (external) party in case of disputes, these logs should not be accessible to anyone. If such logs are necessary to check the proper working of the system, then they should be anonymized beforehand. In the next section, we describe against what threats the system should be immune.

Attacker’s Model There are three kinds of attackers that must be dealt with: •

The first kind of attacker is an entity external to the system (i.e. different from patients, caregivers and employees of the home assistance centre). Typically, it could be a journalist who wants to bring a scoop about the medical condition of a celebrity or it might be a speculator who wants to perpetrate insider trading based on knowledge about the health condition of the CEO of a company quoted on the stock exchange. Also, criminal organizations might want to blackmail individuals or companies they work for, threatening to disclose unfavourable medical prognoses.

Clearly, the system should not make it easier for these nosy people to get the information they desire. On the contrary! Even if these people collude with employees of the centre, they should not be able to acquire more information than what they could find when prying in their victims’ lives. •

Another kind of attacker is a caregiver who belongs to one or more patient’s networks. Here, we must distinguish between medical professionals and other people (cleaning lady, caterer, volunteer, relative, neighbour, etc.). The first category usually has access to the medical data of their patient(s). However, they are bound by a duty of professional confidentiality. Moreover, the system should only allow access to medical staff that belongs to the patient’s network. Hence, a nosy doctor who does not treat the patient, should not be able to see any data concerning the patient’s health.

The second category should never get access to the patient’s medical data. It is well known that because of the prospect of an important inheritance, some family members may want to know the life expectancy of the patient. If they need to be informed, they will so through the patient herself or through her GP or specialist in attendance. •

The last kind of attackers that should be considered consists of employees of the home assistance centre. Clearly, since they have to install the system at the patient’s house and keep it running, they already have some background information that others do not have: e.g. they know which sensors are being used by which patient. However, the system should not provide them with more information than what they learned at the patient’s house.

745

 Commercial Home Assistance Services

Medical data―if kept at the home assistance centre―should not be readable to employees. Strict access control does not suffice, since the system administrator might temporarily change the policies. Unreadable means ‘encrypted’ with a key that is unknown to the employees. Also information about the patient networks should be anonymized (see Figure 2). The silhouettes represent unlinkable pseudonyms; patients’ pseudonyms are in the centre of their star-like patient network and are coloured in black, caregivers’ pseudonyms are coloured in grey. In the figure, some companies and individual caregivers belong to several networks, but are represented in these networks by different pseudonyms. Hence, indiscretions about one network will not reveal anything about other networks. Also, disclosing the complete network database should not reveal more than a set of randomly chosen numbers associated with general attributes, such as roles and rights (see further). Figure 2. Anonymous patient networks. The silhouettes represent unlinkable pseudonyms. The larger (black) silhouettes represent the patients; the smaller (grey) ones represent caregivers or their organizations/companies.

746

 Commercial Home Assistance Services

Note that it is difficult to exclude that employees learn some information about the networks by observing or monitoring the system (e.g. the mobile phone number of the patient’s GP), since at some point, plaintext phone numbers need to be provided to dialing devices. Actually, phone numbers are not necessary when caregivers remain online all the time. However, this assumption is not realistic for now. However, the design of the system should make it extremely difficult to link these phone numbers to pseudonyms of the networks. To summarize, employees are allowed to be curious and may randomly or on purpose browse the system’s databases. However, they should not be able to modify the data (especially the logs), or to tamper with the software so that programmed checks are eliminated or that identifying data (such as phone numbers, email addresses or IP-numbers), which may be temporarily kept in volatile memory is continuously recorded. Also, the content of the text messages sent to mobile devices may leak privacysensitive information about the patient’s health. However, the system should allow for “encoding” such information into―for outsiders―meaningless messages. Unless the offender has complete control over the system and can follow the data flows inside the system, which we consider as highly unlikely, linking contact information or message content to a particular patient, should be very hard to do.

The Global Architecture In this section, we first define the notion of the patient’s network and then give an overview of the major components.

The Patient’s Network First, we describe how the networks are represented inside the system. Because of the privacy requirements, networks need to be anonymized. Note that such a network consists of the patient (at the centre) and all her caregivers. Anonymized self-help groups, which consist of patients with a similar pathology, are outside the scope of this text. The patient’s network consists of the patient (P) herself and one or more (health) caregivers (CG). Note that a caregiver can also be an organization employing caregivers. All members of a network first need to be registered with an administration centre (AC). The patient’s network is created by the patient herself. She can invite other caregivers to join her network. The four-step protocol is described later. Figure 2 shows the representation of these patient networks inside the dispatch centre (DC; see further). Each member is represented by his unique pseudonym (the silhouette), a certificate with the caregiver’s public key and role in the patient’s network and a vault (the vault represents encrypted data) with the caregiver’s identity and contact addresses (e.g. mobile phone number, email address, IP-address, etc.). The caregiver’s and the patient’s pseudonyms are also included in the vault to link the information to that pseudonym and to control to whom the information may be disclosed (cfr. further). The dotted lines around some pseudonyms show that these pseudonyms belong to the same organization or caregiver; however, the database does not contain these relationships and, hence, these pseudonyms remain unlinkable. The patient’s base station maintains a copy of this network; however, there is no need for vaults; all information can be kept in clear text.

747

 Commercial Home Assistance Services

The Major Components The major components of the system are shown in Figure 1. The home assistance service centre (HAC) consists of: • •

• • • •

Administration Centre (AC): Where both patients and caregivers have to register prior to forming or joining a patient’s network; typically, the registration centre will perform all the administrative tasks, such as invoicing, receiving payments, etc; Dispatch Centre (DC): Which is responsible for maintaining the anonymized patient’s networks and self-help groups, assigning and/or scheduling tasks in each network, monitoring the proper working of the base stations, notifying caregivers in case of alert or emergency situations and following up their responses, providing authorized caregivers with access codes for the door system, exercising (coarse-grained) access control to the resources controlled by the base stations, and collecting and archiving evidence of actions taken by the DC; One Base Station Per Patient: Installed at the patient’s home; it interfaces with a control unit, controls several sensors, runs assessment tasks, manages the communication subsystems and generates access tokens for the door system; One Patient Smart Card (SCPT) Per Patient: Storing identity information and master keys necessary to keep the base station running; One Mobile Device Per Caregiver: This is a smartphone that can run a Web browser, but it can also be a mobile phone able to send and receive text messages; Two Trusted Platform Modules (TPMs): One to be used by the DC, the other by the AC; these TPMs are tamper-free devices that convert encrypted data into data encrypted with another key (e.g. the identity of a caregiver), or decrypt (part of) the encrypted plain text (e.g. an email address) under certain conditions. They contain their private key which cannot be extracted from the device.

Relevant Protocols In this section, we describe the protocols for the registration of patients and caregivers (both individuals and organizations), the creation and the extension of the patients’ networks.

Notation and Assumptions The protocols are described graphically. The detailed formulas can be found in the technical report by Milutinovic et al. (2011). The table in Figure 3 explains the meaning of the graphical elements in the figures. In some protocols, we assume that public key pairs and corresponding certificates have been generated prior to running these protocols. In the work of Milutinovic et al. (2011), these assumptions are listed explicitly.

748

 Commercial Home Assistance Services

Figure 3. Overview of graphical elements

Registration With the Administration Centre All parties using this system first need to register with the administration centre. Depending on their role in the system, different procedures are followed: •

Since a patient subscribes to (a subset of) the services of the home assistance centre (cfr. Section ‘Functional Requirements’), she will have to sign a contract with the service provider (possibly with her e-ID card) (cfr. Figure 4.a). A Service Level Agreement (SLA), listing the subscribed services and the conditions, will be agreed upon. The AC will personalize a new patient smart card (SCPT). The patient’s identity, address information and SLA are stored on the card, which will also generate a new pseudonym (NYMPT) and two new key pairs (SKiPT, PKiPT), (i=e (encryption) or s (signing)), one pair for encryption/decryption and the other for signing/signature verification. All cards also share a common authentication key pair (SKCO, PKCO) (cfr. also Vossaert et al. (2010) for the rationale behind this privacy friendly patient card). The AC will issue certificates for the public keys PKiPT and PKCO and subsequently store them on the card. In addition, certificates for the public keys of TPMDC and TPMAC are stored on the card. The card is essential to authenticate the base station towards the DC and the caregivers, and is also used to sign or decrypt information.

749

 Commercial Home Assistance Services

Figure 4. Registration of a patient and an organization

Hence, the base station can only be operational as long as the SCPT remains inserted in the base station’s card reader. To increase the security level, the card can request a PIN code upon first usage; however, this is omitted in this text. The AC’s database records the patient’s pseudonym, certificates, SLA and the encrypted identity and address information. The data is encrypted with the public key of TPMAC; hence, only TPMAC will be able to decrypt that information.

750

 Commercial Home Assistance Services

Later, a base station will be installed in the patient’s home and it will be connected with all the necessary sensors and communication equipment (speakers, cameras, etc.) described in the SLA. •

•

Organizations like hospitals or companies offering paid services (such as cleaning, catering, nursing, etc.) usually require a patient registration or a contract before they are willing to join a patient’s network. Therefore, they will register with the AC (cfr. Figure 4.b), providing the AC with identity and contact information, a list of offered services, and a public key (PKO) certified by an external trusted authority. If AC accepts the registration, it will issue an anonymous credential to that organization (CredO), which includes all the previously exchanged information (including a secret number, randomly chosen by the organization but unknown to AC). The AC’s database will list the organization and all related information. Note that these registrations are not anonymized. Patients can browse this database and look for services they want to use. Most caregivers such as self-employed doctors (GPs) or nurses, relatives, neighbours, volunteers usually register when they are invited to join a patient’s network unless they have been registered previously for another patient (cfr. Figure 4.c). After mutual authentication, the caregiver (CG) provides AC with her identity and address information (e.g. via her e-ID card) and a signed list of her qualifications. Also, for medical personnel, appropriate proofs must be provided (e.g. through a certificate of their professional association or union). Additionally, contact information (phone number(s), email addresses, etc.) is required to allow for sending task schedules or alert messages in case of an emergency. To each contact address, the AC will send an authentication code, which needs to be returned by the caregiver within a limited time. This way, these contact addresses can be authenticated as ‘belonging to the caregiver’.

In the next step, the caregiver generates a new pseudonym (NYMCG) and a randomly chosen number (RANDCG), which is sent under a sealed envelope (i.e. a commitment) to AC. In return, the caregiver receives an anonymous credential (CredCG) which contains her pseudonym, identity, address and contact information, qualifications and the committed random value. Again, AC does not know this value; still, it is embedded in the credential. AC will keep a record of the caregiver’s pseudonym and a vault which contains all the identifying information. Note that this kind of caregiver is anonymized in database.

Requirements for the Patient’s Network When the base station has been installed in the patient’s home, she can create her own patient’s network and invite caregivers (or organizations) to join her network. Depending on the type of caregiver (organization/company versus an individual), a different protocol is followed. Before the protocols are described, we will first focus on the specific requirements for these networks in order to protect the patient’s privacy. 1. The patient’s network should be as anonymous as possible. It should not be possible to identify the patient or one of the caregivers of the network. This implies that both patients and caregivers will be denoted by randomly looking pseudonyms. 2. The network is used for several purposes:

751

 Commercial Home Assistance Services

a. To exercise course-grained access control. The caregiver’s role in the network will determine whether or not a particular operation is authorized or not. E.g. the patient’s GP will be allowed to access the patient’s medical history, but the cleaning organization will obviously not get access to that data; b. To determine which caregiver to notify in case of an emergency; c. To fairly assign tasks that need to be done for the patient. This implies that for the second and third purpose, contact information should be available (e.g. a cell phone number, an email address, etc.). Since contact information can often be assigned to a particular individual, it must not be kept in clear text. Only when contact information is required, it will be deciphered by a trusted and tamper-free device. 3. It should be easy to extend the network with a new caregiver or to remove one from the network. Extensions or removals must be done without revealing the identity of the caregivers involved. Hence, during network operations, the home assistance centre should never learn possibly privacysensitive information (e.g. the caregivers’ specialty). 4. It must not be possible to join a patient’s network without the patient’s consent. It should not be possible to ‘trick’ a patient into allowing a disguised paparazzo into her network. Hence, a patient should be able to discover the true identity of a ‘caregiver’ before giving her consent. 5. If information about a patient’s network is disclosed to the public, it should not affect other networks. Hence, knowing the true identity of one of the caregivers in a network should not make it possible to spot that same caregiver in another network. 6. Finally, to counter denial-of-service or harassment attacks, caregivers will only be able to join a patient’s network, if they can prove that they have been invited by the patient. This requirement avoids that patients may have to dismiss many unjust requests.

Creation of the Patient’s Anonymized Network The patient anonymously authenticates with her patient’s smart card (SCPT) towards the dispatch centre (DC), and DC authenticates towards the card. They both set up an end-to-end secure (SSL) channel, over which the patient’s pseudonym, her certificate and a vault containing her pseudonym, identity and address information (encrypted with the TPMDC’s public key) is sent (cfr. Figure 5). Note that for increased privacy, the patient card can easily generate a new pseudonym which is not linkable to the pseudonym used with the administration centre; however, in this chapter, we will ignore this issue. The card will also generate a new pseudonym when the patient wants to join a self-help group, because ‘social’ networks need to remain strictly separated from ‘patient’ networks. Since DC trusts the patient’s card, the contents of the vault is assumed to be correct. In the database, a new network is created, consisting of one node that lists the patient’s pseudonym, her certificate (binding her pseudonym to her public encryption key PKePT) and the vault with her identity and address information.

752

 Commercial Home Assistance Services

Figure 5. Creation of the patient’s anonymized network

Extending the Patient’s Network Extending the patient’s network happens in four steps: 1. First, the patient invites a caregiver (possibly an organization) to join her network, 2. Later, the caregiver will (anonymously) sign an acceptance/rejection response, 3. Next, the patient receives the caregiver’s response and confirms or rejects the caregiver’s entry into her network. 4. Finally, the caregiver receives a confirmation. If the caregiver is an organization or a company that offers paid services, the patient will frequently need a prior registration and/or contract with that organization/company. For instance, often a contract between the patient and a catering service is made stipulating the kind of meals that need to be served. This is outside the scope of the system and of this text. We assume that this registration or contract

753

 Commercial Home Assistance Services

signing has been completed. Since these organizations/companies will have to agree to cooperate with the home assistance service, we also assume that they already have registered with the administration centre (see section ‘Registration with the administration centre’). As an alternative, it is also possible that these organizations work as subcontractors of the home assistance centre. In this case, the dispatch centre (DC) will have to join the patient’s network in a particular role (e.g. as a caterer or cleaning service). Whenever a task is assigned to that role, the DC will delegate the task to one of its subcontractors. For privacy reasons, subcontracting should be restricted to non-medical tasks; although even then, some indirect medical information may be disclosed to the DC (e.g. dietary constraints such as salt- or gluten-free meals). Therefore, a scheme where organizations directly join the patient’s network seems more privacy-friendly. In a preliminary step, the patient can (anonymously) search the AC’s database for the certificates of the organizations/companies she would like to add to her network. Also, she can pseudonymously request invitation codes from the dispatch centre (DC). The purpose of these codes is to prevent that caregivers request to join a patient’s network without prior invitation of the patient. DC stores for a limited amount of time a fingerprint (a secure hash) of every valid invitation code in the patient’s node (see Figure 5.b). The rest of the protocol differs, depending on whether the caregiver is an organization or not.

An Organization or Company Joins the Patient’s Network The patient has got the caregiver’s certificate and will encrypt her identity, pseudonym, address and additional information (such as social security number or contract number), together with an unused and still valid (previously requested) invitation code. The vault is then sent to the caregiver. Typically, this would be an email that also contains the URL of a JoinMyNetwork-Webservice. The applet loads the caregiver’s private key, opens the vault (i.e. decrypts the ciphertext), loads the caregiver’s anonymous credential (see Figure 6.a), and executes the second step of the protocol (we show only the case where the caregiver accepts to join the network; the opposite response is straightforward). In the second step, the applet establishes a new pseudonym NYMO-PT (which is computed based on the patient’s pseudonym and the random number included in the organization’s anonymous credential) with DC. Next, the applet generates a new key pair (SKO-PT, PKO-PT) to be used for encrypting/decrypting information for that organization. Note that the caregiver is allowed to reuse the same key pair for different patients; however, in that case, it will be possible to link the caregiver’s nodes in the different networks. This should be avoided when the organization is a very specialized medical institution, since this could leak information about the patient’s health condition. The applet then verifiably encrypts the new pseudonym, the patient’s pseudonym, the caregiver’s identity and contact information with the public key of TPMDC. The patient’s pseudonym, vault, fresh public key, delivered services and invitation code are then signed with the organization’s anonymous credential, thereby proving that the pseudonym (NYMO-PT) was correctly computed, that the offered services are listed in the credential and that the data enclosed in the vault are also the correct values. DC will verify the signature (including all the proofs) and the validity of the invitation code; the code is thereafter invalidated. The public key (PKO-PT) is certified in a new certificate and stored in the caregiver’s node in the patient’s network (see Figure 6.b). In the third step, the complete transcript (i.e. all the exchanged messages) and the patient’s certificate are given to the trusted platform module, TPMDC, which will―if all checks verify correctly (cfr. Section ‘Evaluation’)―decrypt the vault and encrypt the transcript, the caregiver’s pseudonym, identity and contact information with the patient’s public key (PKePT). This vault is sent to the patient and forwarded 754

 Commercial Home Assistance Services

Figure 6. Extending the patient’s network with an organization: part 1

to the patient’s card for decryption. The information is shown to the patient who can confirm (or refuse) the admission of caregiver to the patient’s network. If the admission is allowed, the patient assigns a role to the caregiver, and confirms this to DC (via a signature) (see Figure 7c). In the final step, DC will add the caregiver with its role, certificate and vault (containing identity and contact information) to the patient’s network. Also, the TPMDC prepares an encrypted confirmation that includes the pseudonyms, role and patient information (the latter is extracted from the patient’s vault which was constructed when the network was created) (see Figure 7d). This way, the organization can verify whether the invitation contained the correct information, and if not, request to leave the patient’s network.

Private Caregiver This case differs only in some minor details with the previous case. The major differences are: •

The patient does not possess the caregiver’s public key; hence, the vault will be encrypted with the applet’s public key. This key is embedded in the applet through whitebox cryptography (i.e. cryp-

755

 Commercial Home Assistance Services

Figure 7. Extending the patient’s network with an organization: part 2

•

tography in which the secret key is secretly embedded in the code) and changes very frequently. To protect the patient’s privacy, the vault will only contain the patient’s pseudonym. We assume that the caregiver will receive the request via an email that identifies the patient towards the caregiver. (Note that in the final step, the patient’s true identity is revealed towards to caregiver). It is possible that the caregiver will first have to register with AC (the applet will do so if the caregiver does not possess a valid anonymous credential).

The Trusted Platform Modules Figure 8 partly illustrates the functioning of TPMDC: it re-encrypts encrypted information with another key, but only under strict conditions (the TPM will repeat most of the verifications done by the DC and additionally verify that the information belongs to the same patient pseudonym.

756

 Commercial Home Assistance Services

Figure 8. The TPM at the dispatch centre

Beside this function, TPMDC (and also TPMAC) will sometimes decrypt information and return (part of) the plain text. This happens when a caregiver needs to be notified via a text message or via email. In that case, the base station will send a signed request (“Please call one of the following pseudonyms: PN1, PN2, PN3, …”). The TPM receives this request, together with the patient’s certificate and the caregiver’s vault (with contact information). If the request is recent and the caregiver’s pseudonym belongs to the requested set of caregivers, then TPMDC will decrypt the vault and return the required contact information, e.g. the mobile phone number (see Figure 8). Note that all actions of the TPM are securely logged for later auditing. Similarly, TPMAC will decrypt the patient’s address information when invoices need to be sent.

Evaluation In this section, we will review the security and privacy requirements together with the specific requirement for patient’s networks and show that all the requirements are fulfilled.

Security Requirements 1. Non-medical personnel should never get access to personal medical data. This requirement is fulfilled, since neither DC nor AC store any medical data. All health related information is kept locally on the base station. Moreover, caregivers can only access this information when they are a member of the patient’s network and have the required role assigned. The DC can perform coursegrained access control solely based on the caregiver’s role. The base station can further fine-tune this access control based on the identity of the requesting caregiver. 2. The patient’s networks should be anonymized. This is discussed in the privacy requirements 1 until 6. 3. All logging information about what actions have been performed should be treated as extremely confidential. Indeed, the DC will sometimes send text messages or emails to caregivers. Hence,

757

 Commercial Home Assistance Services

phone numbers or address information used during these actions need to be kept confidential. This can easily be fulfilled by encrypting all logging information with the public key of an external trusted third party. Privacy Requirements 1. The patient’s networks should be as anonymous as possible. This is fulfilled, since both patients and caregivers are represented by unlinkable pseudonyms. Also, little extra information is available: only a public encryption key (and possibly a role) is maintained in the nodes. Additional information is kept encrypted with the public key of the TPMDC. The TPMs will only re-key or decrypt (part of) the ciphertext when all the verifications succeed. This prevents that an intruder can use the TPM as an oracle. 2. Contact information should not be kept in clear text. This is fulfilled. Both at the AC and DC is contact information encrypted with the public key of the TPMDC (resp. TPMAC). The contact information is only disclosed when appropriate evidence is provided that it is necessary. Also, the TPMs securely log all their actions for later auditing. 3. The protocols for creating and extending the patient’s network never reveal identifying information to the DC. Both patient and caregiver involved only exchange identifying information which is encrypted with the other party’s public key. The TPMDC is used to assist in securely and trustworthily construct this cypher text. 4. It must not be possible to join a patient’s network without the patient’s consent. This is fulfilled by the four-step protocol. First, a caregiver proves that she is invited by showing a valid invitation code to the DC. Secondly, in the third step, the patient is shown the caregiver’s true identity (and other information), and hence, can accept or refuse the caregiver’s admission to her network. Moreover, both patients and caregivers first have to register with the AC which verifies their identities. Also, the patient’s smart card constructs the patient’s vault and will do so correctly. Furthermore, caregivers are issued an anonymous credential which includes their true identities; when the caregiver generates a signature with that credential, she proves that the vault contains the correct values. Hence, it is impossible to deceive either the DC or the patient. 5. Disclosing information about a patient’s network should not affect other networks. This is easily fulfilled, since pseudonyms are unlinkable and caregivers join different networks under different pseudonyms. 6. Denial-of-Service or harassment attacks should be prevented. This is fulfilled since a caregiver can only request to join a patient’s network when she can show a valid invitation code. To summarize, the HAC fulfils all the privacy and security requirements.

FUTURE RESEARCH DIRECTIONS The system will be extended with anonymous self-help groups with very strict admission procedures. The protocols will be similar to those used in the creation/extension of patient networks.

758

 Commercial Home Assistance Services

CONCLUSION In this chapter, we have described an open but also privacy-friendly home assistance centre, that can be run by a commercial company without the need to employ medical staff. The system is capable of scheduling (recurrent) tasks, continuously monitoring the patients, notifying caregivers, and calling an ambulance in case of an emergency. The system is open because it can interface with all kinds of wearable sensors and communication means and can interact with caregivers and organizations or companies that provide services to patients. The system has been designed in such a way that the home assistance centre never sees medical data. Moreover, it maintains patients’ networks that are completely anonymized. Nevertheless, these networks allow for strict access control and accountability/liability of all the stakeholders. The design of the system realizes a true separation of concerns: assessment and treatment of patients are delegated to the base station in the patient’s home or to caregivers/organizations outside the system.

ACKNOWLEDGMENT This research is partially funded by the Interuniversity Attraction Poles Programme Belgian State, Belgian Science Policy (BCRYPT), the Research Fund K.U.Leuven and the IWT-SBO project (DiCoMas) “Distributed Collaboration using Multi-Agent System Architectures.”

REFERENCES Camarinha-Matos, L. M., & Afsarmanesh, H. (2002). Design of a virtual community infrastructure for elderly care. In L. M. Camarinha-Matos (Ed.), IFIP TC5/WG5.5 Third Working Conference on Infrastructures for Virtual Enterprises (PRO-VE’02): Collaborative Business Ecosystems and Virtual Enterprises, (pp. 439-450). Dordrecht, The Netherlands: Kluwer Academic Publishers. Chakravorty, R. (2006). A programmable service architecture for mobile medical care. In Proceedings of the 4th Annual IEEE International Conference on Pervasive Computing and Communications Workshops (PERCOMW ‘06), (pp. 532-536). Washington, DC: IEEE Computer Society. Corchado, J. M., Bajo, J., Tapia, D. I., & Abraham, A. (2010). Using heterogeneous wireless sensor networks in a telemonitoring system for healthcare. IEEE Transactions on Information Technology in Biomedicine, 14(2), 234–240. doi:10.1109/TITB.2009.2034369 PMID:19858034 De Capitani di Vimercati, S., Foresti, S., Jajodia, S., Paraboschi, S., Pelosi, G., & Samarati, P. (2008). Preserving confidentiality of security policies in data outsourcing. In Proceedings of the 7th ACM Workshop on Privacy in the Electronic Society (WPES ‘08), (pp. 75-84). New York: ACM. Demuynck, L., & De Decker, B. (2005). Privacy-preserving electronic health records. In J. Dittmann, S. Katzenbeisser, & A. Uhl (Eds.), Proceedings of the 9th IFIP TC-6/TC-11 International Conference on Communications and Multimedia Security (CMS 2005), (LNCS), (Vol. 3677, pp. 150-159). Berlin: Springer.

759

 Commercial Home Assistance Services

epSOS. (2011). epSOS - European patients - Smart open services. Retrieved from http://www.epsos.eu/ European MobiHealth Project. (2004). Retrieved from http://www.mobihealth.org Jovanov, E., Raskovic, D., Price, J., Chapman, J., Moore, A., & Krishnamurthy, A. (2001). Patient monitoring using personal area networks of wireless intelligent sensors. Biomedical Sciences Instrumentation, 37, 373–378. PMID:11347420 Kim, H., Jarochowski, B., & Ryu, D. (2006). A proposal for a home-based health monitoring system for the elderly or disabled. In K. Miesenberger, J. Klaus, W. Zagler, & A. Karshmer (Eds.), Computers Helping People with Special Needs, Proceedings of 10th International Conference, ICCHP 2006, (LNCS), (Vol. 4061, pp. 473-479). Berlin: Springer. Kim, W., Lim, S., Ahn, J., Nah, J., & Kim, N. (2010). Integration of IEEE 1451 and HL7 exchanging information for patients’ sensor data. Journal of Medical Systems, 34(6), 1033–1041. doi:10.100710916009-9322-5 PMID:20703604 Korhonen, I., Parkka, J., & Van Gils, M. (2003). Health monitoring in the home of the future. In Proceedings of Engineering in Medicine and Biology Magazine (pp. 66–73). IEEE. doi:10.1109/MEMB.2003.1213628 Milutinovic, M., Decroix, K., Naessens, V., & De Decker, B. (2011). Commercially-run home assistance centres (Technical Report CW612). Department of Computer Science, K.U. Leuven. Riedl, B., Grascher, V., & Neubauer, T. (2008). A secure e-health architecture based on the appliance of pseudonymization. Journal of Software, 3(2), 23–32. doi:10.4304/jsw.3.2.23-32 Sarela, A., Korhonen, I., Lotjonen, J., Sola, M., & Myllymaki, M. (2003). IST vivago reg, an intelligent social and remote wellness monitoring system for the elderly. In Proceedings of 4th International IEEE EMBS Special Topic Conference on Information Technology Applications in Biomedicine, (pp. 362–365). IEEE. Vossaert, J., Lapon, J., Verhaeghe, P., De Decker, B., & Naessens, V. (2010). A smart card based solution for user-centric identity management. In Proceedings of the 6th International Summer School Organised jointly by the EU FP7 Project PrimeLife and the IFIP Working Groups 9.2, 9.6/11.7 11.4, 11.6, Privacy and Identity Management for Life. IFIP. Wood, A., Stankovic, J., Virone, G., Selavo, L., Zhimin, H., Qiuhua, C., & Stoleru, R. (2008). Contextaware wireless sensor networks for assisted living and residential monitoring. IEEE Network, 22(4), 26–33. doi:10.1109/MNET.2008.4579768

ADDITIONAL READING Bajo, J., Fraile, J. A., Pérez-Lancho, B., & Corchado, J. (2010). The THOMAS architecture in home care scenarios: A case study. Expert Systems with Applications, 37(5), 3986–3999. doi:10.1016/j. eswa.2009.11.017

760

 Commercial Home Assistance Services

Bergmann, J., Bott, O. J., Pretschner, D. P., & Hau, R. (2007). An e-consent-based shared EHR system architecture for integrated healthcare networks. International Journal of Medical Informatics, 76(2-3), 130–136. doi:10.1016/j.ijmedinf.2006.07.013 PMID:16971171 Boulos, M., Rocha, A., Martins, A., Vicente, M., Bolz, A., Feld, R., & ... (2007). CAALYX: A new generation of location-based services in healthcare. International Journal of Health Geographics, 6(1), 9. doi:10.1186/1476-072X-6-9 PMID:17352802 Deng, M., De Cock, D., & Preneel, B. (2009). An interoperable cross-context architecture to manage distributed personal e-Health information. In M. M. Cunha, R. Simoes, & A. Tavares (Eds.), Handbook of Research on Developments in e- Health and Telemedicine: Technological and Social Perspectives (pp. 576–602). Hershey, PA: IGI Global. doi:10.4018/978-1-61520-670-4.ch027 Durresi, A., Merkoci, A., Durresi, M., & Barolli, L. (2007). Integrated biomedical system for ubiquitous health monitoring. In T. Enokido, L. Barolli, & M. Takizawa (Eds.), Proceedings of the 1st Network-Based Information Systems, (LNCS), (Vol. 4658, pp. 397-405). Berlin: Springer. ERA. 2007). eHealth ERA - A European Union coordination action. Retrieved from http://www.ehealthera.org Fan, L., Buchanan, W., Thummler, C., Lo, O., Khedim, A., Uthmani, O., et al. (2011). DACAR platform for eHealth services cloud. In Proceedings of the IEEE 4th International Conference on Cloud Computing, (pp. 219-226). IEEE. Field, M. J., & Grigsby, J. (2002). Telemedicine and remote patient monitoring. Journal of the American Medical Association, 288(4), 423–425. doi:10.1001/jama.288.4.423 PMID:12132953 Gatzoulis, L., & Iakovidis, I. (2007). Wearable and portable eHealth systems. IEEE Engineering in Medicine and Biology Magazine, 26(5), 51–56. doi:10.1109/EMB.2007.901787 PMID:17941323 Johnston, B., Weeler, L., Deuser, J., & Sousa, K. H. (2000). Outcomes of the Kaiser permanente telehome health research project. Archives of Family Medicine, 9(1), 40–45. doi:10.1001/archfami.9.1.40 PMID:10664641 Joint NEMA/COCIR/JIRA Security and Privacy Committee (SPC). (2004). Break-glass—An approach to granting emergency access to healthcare systems (white paper). Retrieved from http://www.medicalimaging.org/wp-content/uploads/2011/02/Break-Glass_-_Emergency_Access_to_Healthcare_Systems.pdf Jovanov, E., Milenkovic, A., Otto, C., & de Groen, P. (2005). A wireless body area network of intelligent motion sensors for computer assisted physical rehabilitation. Journal of Neuroengineering and Rehabilitation, 2(1), 6. doi:10.1186/1743-0003-2-6 PMID:15740621 Jurik, A. D., & Weaver, A. C. (2008). Remote medical monitoring. IEEE Computer, 41(4), 96–99. doi:10.1109/MC.2008.133 Kara, A. (2001). Protecting privacy in remote-patient monitoring. Computer, 34(5), 24–27. doi:10.1109/2.920607 Lee, M., & Gatton, T. M. (2010). Wireless health data exchange for home healthcare monitoring systems. Sensors (Basel, Switzerland), 4, 3243–3260. doi:10.3390100403243 PMID:22319296

761

 Commercial Home Assistance Services

Lo, B., Wang, J., & Yang, G. (2005). From imaging networks to behavior profiling: Ubiquitous sensing for managed homecare of the elderly. In Proceedings of the 3rd International Conference on Pervasive Computing. IEEE. Lymberis, A. (2003). Smart wearables for remote health monitoring, from prevention to rehabilitation: Current R&D, future challenges. In Proceedings of the 4th International IEEE EMBS Special Topic Conference on Information Technology Applications in Biomedicine, (pp. 272 – 275). IEEE. Otto, C., Milenkoviç, A., Sanders, C., & Jovanov, E. (2005). Rinton press system architecture of a wireless body area sensor network for ubiquitous health monitoring. Journal of Mobile Multimedia. Otto, C., Milenkovic, A., Sanders, C., & Jovanov, E. (2006). System architecture of a wireless body area sensor network for ubiquitous health monitoring. Journal of Mobile Multimedia, 1(4), 307–326. Rodríguez-Molinero, A., Catalá, A., Díaz, M., Rodríguez, J., Fernández de la Puente, E., Tabuenca, A., et al. the CAALYX Consortium. (2008). CAALYX: Evidence-based selection of health sensors for elderly telemonitoring. In Proceedings of the 6th Conference of the International Society for Gerontechnology. IEEE. Sun, J., Fang, Y., & Zhu, X. (2010). Privacy and emergency response in e-healthcare leveraging wireless body sensor networks. IEEE Wireless Communications, 17(1), 66–73. doi:10.1109/MWC.2010.5416352 Tabar, A., Keshavarz, A., & Aghajan, H. (2006). Smart home care network using sensor fusion and distributed vision-based reasoning. In Proceedings of the 4th ACM International Workshop on Video Surveillance and Sensor Networks (VSSN’06), (pp. 145 – 154). New York, NY: ACM. Tia, G., Pesto, C., Selavo, L., Chen, Y., Jeong, G. K., Jong, H. L., et al. (2008). Wireless medical sensor networks in emergency response: Implementation and pilot results. In Proceedings of 2008 IEEE Conference on Technologies for Homeland Security, (pp. 187-192). IEEE. Varshney, U. (2007). Pervasive healthcare and wireless health monitoring. Mobile Networks and Applications, 12, 113–127. doi:10.100711036-007-0017-1

KEY TERMS AND DEFINITIONS Anonymous Credential: A type of electronic credentials that allows a user to authenticate herself in a privacy-preserving manner. It is possible to prove properties of attributes contained in the anonymous credential without revealing them. Authentication Code: Code used to authenticate a communication means. The administration centre sends such a code to every communication device specified by the caregiver. This code should be copied in the interactive registration form. Caregiver: Any individual or organization responsible for providing care to the patient. Certificate: An (electronic) document consisting of a set of attributes and usually signed by a trusted authority. The signature testifies the validity of the link between the listed attributes.

762

 Commercial Home Assistance Services

Commitment: A commitment scheme allows one party to commit to a value, without disclosing it to a second party. It would be able to reveal the value at some later point, but without the possibility of changing it undetected by the second party. Hash Function: A one-way function that transforms a variable-length bit-string into a fixed-length bit-string. Invitation Code: Code used to prove being invited to join the patient’s network. Public Key Cryptography: Asymmetric cryptography using a pair of keys of which one is made public (the public key) and the other is kept confidential (the private key). It is impossible to derive the private key from the public key. The public key is used to encrypt information, while the corresponding private key is necessary to decrypt the ciphertext. Some schemes allow for signing information (with the private key), and verifying the signature (with the corresponding public key). Symmetric Key Cryptography: Cryptography which uses the same key to encrypt data and to decrypt the ciphertext. Symmetric key cryptography is several orders of magnitude more efficient than public key cryptography. Trusted Platform Module: (TPM): It is a tamper free device that often contains secret keys and/ or private keys which cannot be extracted. It runs a verified operating system that provides a limited number of secure services. Verifiable Encryption: An encryption scheme that allows a party to prove certain properties about an encrypted value without disclosing it.

This research was previously published in the Handbook of Research on ICTs and Management Systems for Improving Efficiency in Healthcare and Social Care edited by Maria Manuela Cruz-Cunha, Isabel Maria Miranda, and Patricia Gonçalves, pages 156-179, copyright year 2013 by Medical Information Science Reference (an imprint of IGI Global).

763

764

Chapter 38

STRIPA:

The Potential Usefulness of a Medical App Floor Aarnoutse Utrecht University, The Netherlands Cassandra Renes Utrecht University, The Netherlands Ronald Batenburg Utrecht University, The Netherlands Marco Spruit Utrecht University, The Netherlands

ABSTRACT Polypharmic patients are patients who chronically use five or more medicines. The number of polypharmacy patients continues to increase even though it is a risk factor for morbidity and mortality. A medication review is an important measure to mitigate medication risks. It is known to effectively reduce the number of drug related problems per (polypharmic) patient. STRIP is a Dutch method to perform a structured medication review. Based on this method, the STRIPA(ssistent) tool is developed. However, whether or not this app is considered useful by the healthcare professional is not known yet. In order to assess this, a systematic literature study is conducted. In addition, an effectiveness study design is described. The results show that there is indeed a need for medication reviews and Dutch healthcare professionals are likely to adopt new technologies, an effectiveness study based on a randomized controlled trial is necessary to assess the effectiveness of STRIPA.

INTRODUCTION In the Netherlands around 10% of the pharmacy visitors are polypharmic patients, which mean they chronically use five or more medicines (KNMP, 2013). Research showed that the number of polypharmacy patients continues to increase and that it is a known risk factor for morbidity and mortality (Hajjar, Cafiero & Hanlon, 2007). In the Netherlands alone, polypharmacy costs society between 103 and 229 DOI: 10.4018/978-1-5225-7122-3.ch038

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 STRIPA

million euros (Zorginstituut Nederland, 2013). Polypharmacy can possibly lead to dangerous combinations of drugs, which can be harmful for the patients. Not only can certain drug-drug interactions be harmful, they can also neutralize the active substances in one another. The chronic use of multiple drugs increases patients’ risks to experience adverse effects, under-prescription, overtreatment, and decreased drug adherence (Meulendijk et al., 2013). Besides that, using multiple drugs also leads to an increased chance of hospitalization (Meulendijk, 2012). Therefore it is of importance that general practitioners (GPs) scan for drug-drug interactions. This can be formally done via a periodic medication review, by which GPs together with pharmacists have to review their polypharmic patients’ medicine use. In the Netherlands there were two methods for medication reviews: the Prescribing Optimization Method (POM) and ‘Gebruik-Indicatie-Veiligheid-Effectiviteit’ (GIVE). There was a need for a unified method and that is why based on the POM method, STRIP (Systematic Tool to Reduce Inappropriate Prescribing) was developed (TPO, 2012). STRIP is a step-by-step method that aims at assisting GPs and pharmacists with determining the optimal medication for polypharmic patients (Meulendijks, 2013) and can be used in software for healthcare professionals. The rise of mobile technology brought exponential growth of software use by healthcare professionals (O’Hagan, 2012). STRIPA, short for STRIP-Assistant, is a STRIP-based app for GPs and pharmacists to use when making a medication review for polypharmic patients. For these medication reviews STRIPA offers several functionalities: • • • • • • •

An overview of the suffered conditions, diseases and medication for each patient. Linking the prescribed medication to the associated diseases. Advice when to start new medication. Advice when to stop current medication. Linking side effects to the associated medication. Showing drug-drug interactions. Advice about medication dosage.

These functionalities will be further elaborated on in the STRIPA section. In 2009 almost a third of all pharmacists did not do a single medication review (Inspectie voor de Gezondheidszorg, 2009). It is hypothesized that this is the case because it takes a lot of time for the pharmacists as well as for the GPs. STRIPA can help these healthcare professionals with making faster and more structured medication reviews. However, it is unknown if GPs and pharmacists see the potential benefits and are willing to adopt STRIPA as a support tool. Therefore the main research question for this paper is: RQ 1: What is the potential usefulness of STRIPA for conducting medication reviews? This research question will be answered based on several subquestions. First of all (i) ‘why is medication reviewing important?’. Answering this question will lead to a better understanding of the field. The second sub question (ii) is ‘what can STRIPA offer?’. Answering this questions will lead to a better understanding of the app. Sub question three (iii) is ‘are there any apps similar to STRIPA?’. This will deepen the understanding about STRIPA and help positioning it within the market. The fourth sub question (iv) is ‘how can an effectiveness study for STRIPA be designed?. By designing an effectiveness study, a foundation for future research is built.

765

 STRIPA

The remainder of this paper is structured as follows; in the next section a systematic literature review will be conducted in order to give a state-of-the-art overview of the current situation regarding medication reviews, drug-drug interactions, polypharmic patients and the usage of e-health by healthcare professionals. This will give an answer to the first sub question. In the third section STRIPA will be introduced, in order to give an in-depth understanding of the app and therefore answer sub question number two. In the subsequent section STRIPA will be compared to existing apps, which answers sub question three. Thereafter an effectiveness study design will be presented. This will answer sub question five. The article concludes with a discussion, conclusion and future research.

1. SYSTEMATIC LITERATURE REVIEW A systematic literature study (SLR) is carried out in order to identify and select research relevant for STRIPA. This section will start with the explanation of the process of the SLR. After that the result of the SLR in the form of related literature is presented.

1.1 SLR Procedure The SLR used in this study is based on the study of Liberati et al. (2009) and is therefore divided in four successive phases; identification, screening, eligibility, included. Figure 1 in Appendix 1 gives an overview of the phases along with the yielded results per phase. •

Identification: Two databases, Google Scholar and PubMed, are searched for relevant articles. PubMed comprises a large number of citations for biomedical literature from MEDLINE, life science journals and online books and thus is purely focussed on medical literature. Google scholar indexes articles across an array of publishing formats and disciplines and includes most peerreviewed online journals of Europe and America. In addition to that Scholar also includes many scholarly publishers, books and other non-peer reviewed journals. By not limiting the search to only the more on-subject database, PubMed, a far larger number of articles can be searched through for the SLR.

Two reviewers independently scanned the electronic records to identify potential articles. In Appendix 2, Table 1, the used search keys and their underlying relationship can be found. These search keys are selected based on their relevance to the subject. Supporting healthcare professionals with making ‘medication review(s)’ is the main functionality of STRIPA. These reviews are focussed on patients who chronically take more than five medicines, called ‘polypharmacy’. STRIPA makes these medication reviews based on the STRIP method, whereby ‘drug interaction’ (how do drugs interact with each other), ‘medicine criteria’ (when to start and stop medication and dosage information), and ‘medicine disease connection’ (which medicines should be used for what disease) are of importance. For each search key subject, there are five layers of identified search keys. In the first layer the ‘general’ search keys for that subject are identified. The second and third layer combine the subjects with the words ‘app’ and ‘e-health’ which is respectively short for application and electronic health. Since STRIPA is ought to be an app to help general practitioners and pharmacists conduct medication reviews, and therefore falls in the category of e-health, these search keys are included. The last two

766

 STRIPA

layers combine the subjects with the words ‘general practitioner information system’ and ‘clinical decision support software’. STRIPA is a clinical decision support software which can be integrated with the general practitioner information system. By also including these four extra layers literature based on similar projects can be found. For each search key the two databases were scanned. These search keys yielded a total of 3.005.135 results divided over PubMed (112.847) and Google Scholar (2.892.288). •

•

•

Screening: Of the roughly 3 million results, 4.759 records are screened. This is done by reading the titles and when deemed maybe relevant for this research, also the abstract. Per relevant keyword the first 100 results were searched trough for PubMed as well as Google Scholar. However, some keywords did not yield 100 results and other keywords were deemed not relevant enough. This was the case when after 40-60 results none of the screened titles were slightly interesting for this research, at which case the search stopped. Therefore divided over the 34 search key and two databases, 4.759 records are screened. Based on this title and abstract screening, 105 articles were deemed interesting for this research. 38 of which originated from PubMed and 67 of Google Scholar. Consequently, 4.654 screened articles were deemed not interesting enough and are dismissed. Eligibility: In order to access the eligibility of the remaining 105 articles, the full texts of these articles are sought. Of 34 articles no full text could be found and were thus excluded from further analysis. The full texts of the remaining 71 articles were further analysed on their added value to the literature review. The articles are divided into four different categories; (1) duplicates, (2) not applicable and (3) not relevant and (4) include in review. Duplicates are articles which came up in Google Scholar as well as PubMed and were in both cases included in the results. In total, there were eight duplicate articles. Seven articles were deemed not applicable. These articles were often solely based on countries apart from the Netherlands, and could not be generalized due to their research approach or because they were based on a device not used for STRIPA, for example PDAs. The last category in which articles are excluded are the articles which are deemed not relevant. An article is deemed not relevant when it is too specifically aimed at a disease, technique, target group etcetera. Also articles which were too general or did not fit in after all were deemed not relevant. In total 29 articles belong to this group. Included: A total of 27 articles were left to include in the literature review. When analyzing these articles some general concepts can be distinguished compliant with the search keys. In Appendix 2, Table 2, the references to the included literature as well as the concepts they entail, can be found. E-health is identified in most of the articles. A broad view of e-health is used, in which also apps, clinical decision support software and general practitioners information systems are reckoned in this term. The only search key missing in the concept table, is medication disease connection, because none of the selected articles are found based on this search key. In the next section, related literature, the result of the analysis of the included articles can be found.

1.2 Related Literature There are a lot of papers reporting about side-effects of different drugs. Scanlin (2013) stated: “The more powerful a drug is, the more likely it is to have harmful side effects. The Institute of Medicine (IOM) of the National Academies estimates (...) that there are between 44.000 and 98.000 hospital deaths annually

767

 STRIPA

attributed to medical errors, more than 7.000 of which are due to medication errors.” Based on this it can be stated that reviewing medication is important, the question remains whether or not it is also effective. Multiple studies have been conducted to measure the effectiveness of these medication reviews (Seidling et al., 2011; Krska et al., 2001; Vinks, Egberts, de Lange & de Koning, 2009; Bindoff, Tenni, Peterson, Kang & Jackson, 2007). In a randomized control trial in the United Kingdom 332 records of patients aged 75 years and above or those who uses multiple medicines were reviewed. The results showed that all patients had at least two drug related problems (Krska et al., 2001). A study about the effectiveness of medication reviews in the Netherlands between GPs and pharmacists, showed a positive influence in reducing potential drug related problems for elderly. The results showed a significant reduction in the mean number of drug related problems per patient. The mean number of drugs per patient did not significantly reduce after the medication review (Vinks, Egbert, de Lange & de Koning, 2009). Another effectiveness study about medication reviews in Australia showed that not only significantly less drug related problems per patients were found, but also that a decision support system (DSS) for medication review found significantly more potential drug related problems than healthcare professionals without a DSS (Bindoff, Tenni, Peterson, Kang & Jackson, 2007). A medication review is an important measure to mitigate medication risks, but not all patients can be reviewed. A research in Sweden looked at the potential drug-drug interactions and concluded that there was a strong correlation between drug related problems and the use of multiple drugs. The pronounced increase in polypharmacy over time implies a growing reason for prescribers and pharmacists to be aware of drug-drug interactions (Åstrand, Åstrand, Antonov & Petersson, 2007). A conclusion can be drawn that medication reviews can substantially improve patient safety and that information systems positively support the medication review process by reducing drug error rates (Kaushal, Shojania & Bates, 2003; Bates & Gawande, 2003; Miller, Gardner, Johnson & Hripcsak, 2005; Drenthvan Maanen, van Marum, Knol, van der Linden & Jansen, 2009; McInnes, Saltman & Kidd, 2006). The main driver behind implementing a computerized physician order entry for Dutch physicians is patient safety (Aarts & Koppel, 2009). Ko et al., (2007) stated “both prescribers and pharmacists indicated that the CPOE [Computerized Prescriber Order Entry] system had a neutral to positive impact on their jobs”. Even though these information systems are useful, they are not always adopted by the users. A research about the implementation of DSS or CPOE systems in seven western countries showed that the United States and the Netherlands have the highest use rates. Healthcare professionals in the United States, the United Kingdom, Switzerland, and the Netherlands are most likely to have integrated decision support systems (Aarts & Koppel, 2009). An American survey held under 1.745 pharmacists concluded that DSSs often fail to protect patients from harmful drug-drug interactions. The potential risk of drug-drug interaction depends on a number of drug and patient specific factors. DSSs should pay attention to these factors (Horn et al., 2013; Smithburger, Buckley, Bejian, Burenheide, Kane-Gill, 2011). In addition, “the effectiveness of computerized clinical decision support systems (CDSSs) depends on the quality of the knowledge they refer to” (Mille, Degoulet & Jaulent, 2007), it is important to include the knowledge of healthcare professionals in the system. One major problem with the adoption of DSSs is that users ignore the alerts and advises the system produces. A lot of research has been done to study how many alerts and advises are ignored and more importantly why they are being ignored (Ko et al., 2007; Kmetik, Chung, Sims & Found, 2007; Ahearn & Kerr, 2003). Through a questionnaire the reasons for overriding drug alerts by GPs in the UK are examined. 236 GPs participated in this study. 22% of the GPs admitted they frequently to very frequently 768

 STRIPA

override drug alerts. The main reason for overriding drug alerts was that the drug alert was not relevant. 90% of the GPs stated that it should be harder to ignore drug alerts (Magnus, Rodgers & Avery, 2002). When tiering the alerts into categories based on severity, alerts were not as quickly ignored. In an American research, 71.350 alerts were investigated. A correlation was found between tiering the alerts and overriding the alerts. From the 31.876 tiered alerts, 100% of the most severe alerts were accepted against 34% of the total 39.474 non tiered alerts. Also moderate severe alerts had a higher acceptance rate with tiered alerts (29%) against non tiered alerts (10%) (Paterno et al., 2009). In Australia the opinion of 191 GPs and 138 Pharmacists about alerts were analysed. The vast majority of the respondents wanted to be able to differentiate the alerts by severity. The research states that it should also be harder for physicians to override alerts for severe interactions and that it should be mandatory to provide a reason when they do override an alert (Yu, Sweidan, Williamson & Fraser, 2011). Another aspect that should be taken into consideration with these kinds of systems is that “Doctors may not be aware of all the drugs their older patients are taking. Frank and colleagues reported that in a study in Canada 37 per cent of patients were taking drugs without their doctors’ knowledge, and 6 per cent of patients were not taking medications that were on their doctors’ lists” (Duerden, Avery & Payne, 2013). STRIPA does not include these aspects in their assessment, while these aspects do influence the interaction with other drugs.

1.3 Lessons Learned There are several lessons learned from the analysis depicted in the previous section. First of all, medical errors due to medication errors are not uncommon and polypharmacy is increasing in frequency. The dangers accompanying polypharmacy can be reduced due to medication reviews, since these reviews improve patients’ safety substantially. This is proven to be true in multiple countries including the Netherlands. DDSs supporting these medication reviews can significantly increase the chance of identifying potentially harmful drug-drug interactions. These DDSs have a chance to do well in the Netherlands, since a study about the implementation of DSS or CPOE systems in seven western countries showed that the United States and the Netherlands have the highest use rates. However traditional DSSs (not aimed at medication reviews) often fail to protect patients from harmful drug-drug interactions, therefore future (versions of) DSSs should take the number of drugs, their interactions and specific patient factors into account. In addition, the effectiveness of a DSS also depends on the quality of knowledge they refer to. However one major problem with the use of DDS’s by healthcare professionals is that they often ignore the alerts and advises the system produces. This can be overcome by tearing the alerts into categories based on severity, this leads to less ignored alerts and advices. Besides that, health care professionals are not yet aware of all the drugs patients are taking. This is because some drug can be bought without a prescription and patients are not sharing this with their doctors or because patients are without informing their doctors stop taking their prescribed medicine.

2. STRIPA STRIPA is an online software service to support GPs when prescribing medication and to support GPs and pharmacists when reviewing the medication of their polypharmic patients. STRIPA is based on the STRIP method for medication review. The STRIPA tool can be used as an integrated software program

769

 STRIPA

which interacts with the information system of the GPs and the pharmacies. The medication reviews performed by the GPs and pharmacists are used to improve the generated advises when performing another medication review. Next to this integrated software, an app version is also available.

2.1 STRIPA Drivers Polypharmacy is associated with several medical problems, like under-prescription, overtreatment, increasing risk of adverse effects, and decreased drug adherence. These medical problems are also described as drug related problems. When performing medication reviews, drug related problems can be identified. Previous research shows that out of 1.489 medication reviews, an average 3.1 drug related problems were found per patient. In this research pharmacies did not include all problems they identified, therefore the actual amount of drug related problems per patient is even higher (Service Apotheek, 2012). KNMP (2013) investigated 507 medication reviews in the Netherlands and found an average of 3.6 drug related problems per patient. Identifying these problems and adjusting the medication leads to less medication usage and less hospital admissions. Booz (2012) stated that when 10-12% of the medicine usage can be stopped and 15-17% of the unplanned hospital admissions can be prevented when executing a medication review, the Netherlands can save up to €150-200 million. To support medication review a decision support system, STRIPA is designed. Meulendijk (2012) stated that after implementation of STRIPA in the Netherlands, mortality can be expected to decrease by 3 to 19 persons on a yearly basis, morbidity by 4 to 28 persons, and the financial cost by 10 to 45 million euros per year. To encourage GPs and pharmacists to perform medication reviews, in the Netherlands healthcare providers financially reward the GPs and pharmacists whenever they perform a medication review (Inspectie voor de Gezondheidszorg, 2009). They can send an invoice to the healthcare providers for each medication review they performed. Through a step-by-step method GPs are forced to critically review the medication use of their polypharmic patients. All the patient information is included in the STRIPA system.

2.2 STRIPA Functionalities All screenshots mentioned in this section about STRIPA can be found in Appendix A, this includes an overall screenshot of STRIPA which is screenshot 1. In this case the dossier of Mrs. Kwarten is shown. Mrs. Kwarten is 93 years old and suffers from several conditions. These conditions are visualized at the top of the screen. She suffers from flatulence, nausea and an impaired kidney function. Next to the conditions, the lab results for several functions, like heart rate and blood pressure, are stated. These results help the GP with diagnosing the patient. The GP has previously diagnosed several diseases with Mrs. Kwarten. These diseases are shown at the left side of the system. The GP can enter more diseases if deemed necessary. For some of these diseases the GP has prescribed medication. The medicines are listed at the right side. Besides an overview of the conditions, diseases and medication, STRIPA has several other functionalities. First, the STRIPA makes it possible to link the prescribed medication to the diseases. In screenshot 2, all the medicines are linked to the diseases. This process highlights redundant medication. STRIPA holds data about the lab results and conditions of the patients, with this information STIRPA gives advice about when a patient should start with a new medicine. Because Mrs. Kwarten suffers from atrial fibrillation, a new medicine should be prescribed. STRIPA suggests several medications which addresses the condition and do not interfere with other prescribed medication. The GP can choose whether to add

770

 STRIPA

the new medicine to the prescription or to ignore the condition. When the GP adds the medication, the medicine is automatically linked to the disease in the disease overview, this is shown in screenshot 3. In addition, STRIPA advises when a patient can stop using a certain medicine. In screenshot 4 STRIPA advises to stop using acetylsalicylic acid because the patient has no history of coronary, cerebral or peripheral vascular symptoms. Again, the GP can choose to accept or deny the given advice. The subscribed medication has several side effects. The GP can connect these side effects to the associated medication. Screenshot 5 shows the GP drag the side effect nausea to the medicine euthyrox tablet. Furthermore, STRIPA shows drug-drug interaction warnings. When prescribing multiple medicines to a patient, the consequences of using these medicines together are not always clear. Whenever a drug has an unwanted effect, a warning is given, shown in screenshot 6. In the example of Mrs. Kwarten four drug-drug interactions are identified. STRIPA advices another medication which has the same effect but has different constituents. The GP can choose whether to ignore the interaction warning and prescribe the drug he wanted, or listen to the advice of the STRIPA. Based on values like weight and age, medications have a certain dosage. After checking for drug-drug interactions, STRIPA checks for under- and overdosage. In the case of Mrs. Kwarten only two tablets of calci chew d3 are allowed while two and a half tablets are prescribed (Screenshot 7). After these steps, the medication is optimized. STRIPA shows an overview, visualized in screenshot 8. On the left side all the medications are connected to the diseases and any potential side effects are listed with their associated medication. On the bottom the bin is located, which shows all the deleted or changed medication during the process. In this overview the GP can check if everything is correct and if necessary reverse the made changes or make new changes.

2.3 STRIPA Status The STRIPA system is currently being tested through a clinical experiment and a one-year longitudinal study. The results of these tests will become available in 2015. Next to the STRIPA system, an app is being developed. This app currently is in the development phase. O’Hagan (2012) stated “there is tremendous potential for customized care through mobile devices”. Therefore transforming the STRIPA system into an app can be an added value. The app will work on both Android and iOS and is developed for tablets (10 inch or bigger). The app is not designed for smartphone use. Because the app contains a lot of information, fitting it on a screen of 10 inch or smaller would indicate leaving out important information. All the information addressed in STRIPA is of equal importance therefore no information can be left out.

2.4 Preliminary Results Looking at the lessons learned in section 2.3 and the information about STRIPA, some tentative conclusions can be formulated. Since there is an increasing amount of people with polypharmacy, and medication errors are not uncommon, there is a market for tools, software, procedures etc. which helps prevent these medication errors. Especially medication reviews are proven to reduce the amount of drug related errors. Therefore it can be stated that there is a use for an app that focuses on medication reviews, like STRIPA. DDS and CPOE systems have the highest use rates in the Netherlands, this positively influences the chances STRIPA is adopted by Dutch healthcare professionals. It is suggested that DDSs should take the number of drugs, their interactions and specific patients factors into account in order to protect the patient better from harmful drug-drug interactions. STRIPA considers both the drug and

771

 STRIPA

patient specific factors, and therefore addresses this issue. In addition, the effectiveness of a DSS also depends on the quality of knowledge they refer to. The generated advises by STRIPA are based on the medication reviews performed by the healthcare professionals themselves, this insures the quality of the advices are continuously improved and of a high standard. A problem with DDS’s is that advises and alerts are often ignored by the healthcare professionals. This can be overcome by tearing the alerts into categories based on severity, which is proven lead to less ignored advices and alerts. STRIPA does not differentiate its alerts and advices by severity, it should be a good alternation in future releases.

3. RELATED APPS There are two other apps for general practitioners and pharmacies to support the medication review process similar to STRIPA: Epocrates and MicroMedex Drug Information (O’Hagan, 2009), both apps focus on healthcare professionals. There are multiple other applications available but these applications only focus on one aspect of medication reviews. Epocrates has a free version, which provides information on drugs, interactions and a pill ID function. According to the Epocrates website “nearly 1 in 2 U.S. physicians rely on Epocrates routinely to help inform their decisions in the moments of care, making it the #1 medical app available to U.S. physicians” (Epocrates, 2014). Epocrates also has a premium version with features like suggesting alternative drugs, insight in lab results and disease information. Epocrates is available for Android and iOS. For Android alone, Epocrates has been downloaded over a million times with an average rating of 4.3 out of 5 (n = 19.356) (Google Play, 2014a). For iOS the average rating is 3 out of 5 stars (n = 46.934) (iTunes, 2014a). MicroMedex Drug Information is a subscription based app and costs $2.99 a year. It provides an extensive index of medications, which includes information about dosage, drug-drug interactions and a tool for pill identification (Micromedex, 2014). MicroMedex Drug Information has been downloaded over 5000 times for Android, with an average rating of 4.2 (n = 56) (Google Play, 2014b). For iOS the average rating is around 2 stars (n = 176) (iTunes, 2014b). In Appendix 2, Table 3, the apps are compared according to functionality and rating. This table shows the uniqueness of STRIPA. STRIPA is the only app with information about the condition of the patient, start and stop criteria of the all medication and a functionality which links the medication to the diseases. Only pill identification, information about other healthcare professionals and general drug information is not included in STRIPA. However, these functionalities are not of importance when conducting a medication review.

4. EFFECTIVENESS STUDY DESIGN An effectiveness study should be carried out in order to test whether or not STRIPA is deemed effective for GPs and pharmacists. This effectiveness study should focus on the perceived effectiveness of STRIPA. In order to test this, the development of STRIPA should be finished first. There are several study designs possible for researching effectiveness (Baxter & Jack, 2008). Based on research of Stolberg, Norman and Trop (2004) and the University of Ottawa (uOttawa, n.d.) the randomized controlled trial (RCT) is chosen to test the effectiveness of STRIPA. In RCT a predefined group of subjects is randomly allocated to two or more groups. One group is assigned as a control group,

772

 STRIPA

while the other groups are assigned to an intervention. After the experiment, outcomes of both groups are measured and compared to each other. An advantage of RCT above other study designs, is that it is considered to be the most reliable form of scientific evidence (Akobeng, 2005), since it reduces bias (uOttawa, n.d.). This is the case because the subjects are randomly allocated to one of the two groups, which ensures homogeneity between the groups. Therefore, when comparing the groups to each other after the experiment, the difference between those groups must be caused by the experiment. There are also some disadvantages to RCTs. For example, the external validity can be not sufficient enough. This is for instance the case when only comparing groups in a specific country, then it may not be generalizable to another country with different norms, believes et cetera. In the STRIPA experiment however, this is not a threat. Since STRIPA is intended to use within specific boundaries (in the Netherlands, by GPs and pharmacists) these boundaries can serve as an input for the experiment. Another disadvantage of RCTs is the narrowness of the studied question. RCTs usually only inspect one variable or very few variables, rarely looking at the full picture (Singh, Kumar & Sarkar, 2011). When conducting an experiment about STRIPA the subjects are GPs and pharmacists. It is estimated that in the Netherlands there are 9.115 GPs and 2.644 pharmacists (Nederlandse patiënten consumenten federatie, 2014). In order to have a representative sample for an effectiveness study, 396 GPs and 336 pharmacists should participate in the experiment. This is calculated based on the standard sample size formulae, with a confidence interval of 5 and a confidence level of 95%. The participating GPs and pharmacists should both be randomly divided in two equal sized groups. Both groups should be presented with the two cases discussed in the end-user survey section, since those cases are representative for the problems that can arise when conducting a medication review for polypharmic patients. The control group should perform the STRIP method with pen and paper and the intervention group by means of STRIPA. When comparing the results of the two groups there are several measurements that should be taken into account. The time to complete the two cases is of importance, since it is claimed that STRIPA reduces the time to complete a medication review. In addition, also the medication and dosage changes should be measured. In this way it can be measured if one of the groups makes significantly more errors than the other. An error is deemed as such, whenever a healthcare professional does not change a medication or medication dosage when it forms a threat to the patient or when a healthcare professional changes the medication or medication dosage into a (still) harmful combination. In addition, also not optimal changes in medication should be deemed as errors. Whether one of the groups makes significantly more errors than the others can be calculated with any statistical significance test. The costs for such an experiment can be high, when paying all subjects their normal hourly wage in addition to the costs of the researchers themselves and the distribution of STRIPA to the intervention group. In order to suppress the costs, the healthcare professionals should be asked to participate voluntarily. Since only 4.05% of the GPs and 12.7% of the pharmacists in the Netherlands are needed to conduct this experiment, it should be possible to at least move a part of the healthcare professionals to participate voluntarily. This voluntary group will do so based on intrinsic drivers, like ‘the feeling to give something back’ and ‘the feeling of accomplishment’ (Noels, 2001), or the possibility to get to try STRIPA free-of-charge. When the intended amount of subjects is not reached, the healthcare professionals should be promised a financial compensation, in order to move them to participate.

773

 STRIPA

5. DISCUSSION In this research, there are some threats to the validity of the results. First of all, the SLR could be extended by including more specific search keys. However, the most crucial parts are already included in this version. Besides a more thorough SLR, from the 39 analyzed respondents, there were only four pharmacists. To give more accurate conclusions about the adoption of STRIPA, the overall sample size needs to be bigger and especially more pharmacists should be included. STRIPA is an extensive tool to support medication reviews. It gives alerts whenever a drug related problem is present. In STRIPA healthcare professionals can easily ignore these alerts. Previous research has shown that tiering these alerts into categories according to severity help healthcare professionals to make the right decisions. Alerts from the most severe category are rarely ignored. STRIPA should add these tiered alerts. Furthermore, STRIPA does not include information about the reliability of a patient. How frequent a patient takes their medication has great consequences on the overall treatment. Taking the patient reliability into account could be an added value for STRIPA since alternative treatments may be more effective. In the experiment and end-user survey mentioned in this research two cases were used to test the potential usefulness of STRIPA. To measure the effectiveness, a RCT should be performed. The RCT clearly shows the effectiveness of STRIPA but it remains an experiment in a controlled environment. All the participants use the same cases to perform a medication review and the differences between the control group and the intervention group are measured. The narrowness of the studied question within a RCT does not examine the ‘complete picture’. Therefore this type of experiment does not include how healthcare professionals use STRIPA in their daily life for real patients. This includes that in practice GPs and pharmacists will regularly work together whenever they perform a medication review. In the experiments mentioned before the differences between usage of GPs and pharmacists is measured but how these groups collaborate is not known.

6. CONCLUSION Based on the research described in this paper, the main research question of this paper ‘what is the potential usefulness of STRIPA for conducting medication reviews?’ can be answered. There are between 44.000 and 98.000 hospital deaths annually attributed to medical errors, of which more than 7.000 are due to medication errors. These medication errors cost a lot of money and certain errors can be avoided. A medication review is one way of reducing the amount of medication errors. Multiple studies have proven the effectiveness of medication reviews. To support GPs and pharmacists when performing medication reviews for polypharmic patients STRIPA offers a step by step-by-step method. STRIPA has several functionalities, including an overview of the patient with the condition and medication; linking the medication to the associated diseases; advice when to start and stop with a certain medication; linking side effects to the associated medications; drug-drug interactions; and advice about medication dosage. There are some similar apps to STRIPA, but none of these apps has all the functionalities combined in one app like STRIPA does. Furthermore, research showed that after implementation of STRIPA in the Netherlands, mortality can be expected to decrease by 3 to 19 people on a yearly basis, morbidity by 4 to 28 people, and the financial costs by 10 to 45 million euros a year.

774

 STRIPA

An effectiveness study should be carried out in order to test whether or not STRIPA is deemed effective for GPs and pharmacists.

7. FUTURE RESEARCH Because the effectiveness study and the performed experiment mentioned in this research both include two predefined cases, an observational study would be a good addition. In the observation study the healthcare professionals use the system when conducting medication reviews on real patients. The RCT and observational study together give a complete picture how effective STRIPA is. This observation study includes studying the collaboration of GPs and pharmacists. To test if the functionalities of tiered alerts and taking the patient reliability into account is an added value for STRIPA, additional research should be performed. No research is available whether these two extra functionalities increase the value of STRIPA. This future research should examine how GPs and pharmacists handle the alerts when they are tiered into different categories according to severity. Moreover, not all patients take their medication according the prescription. This affects the overall treatment and should be included in the medication review. Missing in this research is the preference of healthcare professions for a mobile app. At the moment STRIPA is only available for a PC. In the future STRIPA will be available for tablets, both Android and iOS. However it can be the case that healthcare professionals do not see the need to use STRIPA on tablets, this need exists should be researched. In this research, as well as previous research about STRIPA, only GPs and pharmacists are included. STRIPA could be beneficial for a broader audience. STRIPA is mainly focused on elderly patients, therefore STRIPA could be useful for other healthcare professionals like homecare nurses and even for informal care providers and patients themselves. Certain STRIPA functionalities, like the drug-drug interaction feature, can support these other user types. For example, functionalities like start and stop criteria for medication are not applicable for all types of users. A study should be conducted in order to understand the needs of the different user types. This need can be translated into different user profiles with different STRIPA functionalities. A reason for healthcare professionals to use STRIPA may also rely on a CE certification, which can cost a lot of money and time. Before determining the most appropriate level of CE certification, research should be conducted to examine the extent to which the attitude towards STRIPA changes positively with a CE certification level. This should also include a cost benefit analysis. STRIPA is tentatively scheduled for public release on the Dutch market in 2015.

REFERENCES Baxter, P., & Jack, S. (2008). Qualitative case study methodology: Study design and implementation for novice researchers. Qualitative Report, 13(4), 544–559.

775

 STRIPA

Booz & Company. (2012). The potential for pharmaceutical quality services. Available from: http://www. knmp.nl/downloads/nieuws/nieuws-2012/booz-co-the-potential-for-pharmaceutical-quality-services. pdf/view Epocrates. (2014). Epocrates overview. Available from: http://www.epocrates.com/products Google Play. (2014a). Epocrates. Available from: https://play.google.com/store/apps/details?id=com. epocrates&hl=en Google Play. (2014b). Micromedex Drug Interactions. Available from: https://play.google.com/store/ apps/details?id=com.thomson.druginteractions&hl=en Inspectie voor de Gezondheidszorg. (2009). Het resultaat telt. Available from: http://www.farmaactueel. nl/beleidsstukken/IGZ2009.pdf iTunes. (2014a). Epocrates. Available from: https://itunes.apple.com/en/app/epocrates/id281935788?mt=8 iTunes. (2014b). Micromedex Drug Interactions. Available from: https://itunes.apple.com/us/app/ micromedex-drug-interactions/id391763035?mt=8 KNMP. (2013). Medicatiebeoordeling. Available from http://www.knmp.nl/downloads/organisatieregelgeving/organisatie-regelgeving-normen-en-richtlijnen/richtlijnmedicatiebeoordeling.pdf Krska, J., Cromarty, J. A., Arris, F., Jamieson, D., Hansford, D., Duffus, P. R., ... Seymour, D. G. (2001). Pharmacist‐led medication review in patients over 65: A randomized, controlled trial in primary care. Age and Ageing, 30(3), 205–211. doi:10.1093/ageing/30.3.205 PMID:11443021 Liberati, A., Altman, D. G., Tetzlaff, J., Mulrow, C., Gøtzsche, P. C., Ioannidis, J. P., ... Moher, D. (2009). The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: Explanation and elaboration. Annals of Internal Medicine, 151(4), W-65. doi:10.7326/0003-4819-151-4-200908180-00136 PMID:19622512 Meulendijk, M. (2014). STRIPA. Unpublished Raw Data. Nederlandse patiënten consumenten federatie. (2014). Zorgkaart Nederland. Available from: http:// www.zorgkaartnederland.nl/apotheker Nederlandse Service Apotheek Beheer B.V. (2012). Analyse Medicatiebeoordeling t.b.v. de KNMP Richtlijn Medicatiebeoordeling. Available from: www.serviceapotheek.nl Noels, K.A. (2001). New orientations in language learning motivation: Towards a model of intrinsic, extrinsic, and integrative orientations and motivation. Motivation and Second Language Acquisition, 23, 43-68. Stolberg, H. O., Norman, G., & Trop, I. (2004). Fundamentals of Clinical Research for Radiologists. AJR, 183, 1539–1544. doi:10.2214/ajr.183.6.01831539 PMID:15547188 TPO. (2012). Nieuwe multidisciplinaire richtlijn polyfarmacie ouderen. Tijdschrift voor praktijkondersteuning. Available from http://www.tijdschriftpraktijkondersteuning.nl/archief/volledig/id689-nieuwemultidisciplinaire-richtlijn-polyfarmacie-ouderen.html

776

STRIPA

uOttawa. (n.d.). Study Designs. Available from http://www.med.uottawa.ca/sim/data/Study_Designs_e.htm Zorginstituut Nederland. (2013). Fact sheet polyfarmacie. Available from: https://www.zorginstituutnederland.nl/binaries/content/documents/zinl-www/kwaliteit/meerjarenagenda/agenda-2013/agenda-2013/ agenda-2013/zinl%3Aparagraph%5B7%5D/zinl%3Adocuments%5B4%5D/1306-fact-sheet-polyfarmacie/ Fact+sheet+polyfarmacie.pdf

This research was previously published in Advancing Pharmaceutical Processes and Tools for Improved Health Outcomes edited by Tagelsir Mohamed Gasmelseid, pages 114-135, copyright year 2016 by Medical Information Science Reference (an imprint of IGI Global).

777

STRIPA

APPENDIX 1: FIGURES

Figure 1. Systematic literature review process

778

STRIPA

Figure 2. Screenshot 1: STRIPA

Figure 3. Screenshot 2: drug-medication combination

779

STRIPA

Figure 4. Screenshot 3: start criteria medication

Figure 5. Screenshot 4: stop criteria medication

Figure 6. Screenshot 5: connection effect to medication

780

STRIPA

Figure 7. Screenshot 6: drug-drug interaction alert

Figure 8. Screenshot 7: dosage medication alert

781

STRIPA

Figure 9. Screenshot 8: overview

APPENDIX 2: TABLES Table 1. Search keys Drug Interaction

General

Polypharmacy

Drug interaction

Polypharmacy

Drug interactions

Polypharmacy elderly

Drug drug interaction

Polypharmacy APK

Drug drug interactions

Medicine multiplicity

Drug interaction study

Polypharmaxy optimization method

Medicine Criteria

Medicine Decease Connection

Medication Review

Medicine criteria

Medicine disease connection

Medication review

POM App

Drug interaction app

Polypharmacy app

Medicine criteria app

Medicine disease connection app

Medication review app

E-health

Drug interaction e-health

polypharmacy e-health

Medicine criteria e-health

Medicine disease connection e-health.

Medication review e-health

General practitioners information systems

General Practitioners information system drug interaction

General practitioners information system polypharmacy

General practitioners information system medicine criteria

General practitioners information system medicine disease connection

general practitioners information system medication review

Clinical decision support software

Clinical decision support software Drug interaction

Clinical decision support software Polypharmacy

Clinical decision support software medicine criteria

Clinical decision support software medicine decease connection

Clinical decision support software medication review

782

STRIPA

Table 2. Concept table Reference

Drug-Drug Interaction

E-Health

Health Care Specialists

Magnus, D., Rodgers, S. and Avery, A. J. (2002). GPs’ views on computerized drug interaction alerts: questionnaire survey. Journal of clinical pharmacy and therapeutics, 27 (5), 377-382.

X

X

X

Kmetik, K.S., Chung, J., Sims, S. and Found, N.R. (2007). Reasons provided by prescribers when overriding drug-drug interaction alerts. Am J Manag Care, 13, 573-580.

X

X

X

Paterno, M.D., Maviglia, S.M., Gorman, P.N., Seger, D.L., Yoshida, E., Seger, A.C., ... and Gandhi, T. K. (2009). Tiering drug–drug interaction alerts by severity increases compliance rates. Journal of the American Medical Informatics Association, 16(1), 40-46.

X

X

O’Hagan, E. (2012). Getting started with medical apps: Apps you should know about. Journal of Hospital Librarianship, 12(2), 162-170.

Medication Review

X

Yu, K. H., Sweidan, M., Williamson, M. and Fraser, A. (2011). Drug interaction alerts in softwarewhat do general practitioners and pharmacists want?. The Medical journal of Australia, 195(11-12), 676-680.

X

Åstrand, E., Åstrand, B., Antonov, K. and Petersson, G. (2007). Potential drug interactions during a three-decade study period: a cross-sectional study of a prescription register. European journal of clinical pharmacology, 63(9), 851-859.

X

X

X

McInnes, D.K., Saltman, D.C. and Kidd, M.R. (2006). General practitioners’ use of computers for prescribing and electronic health records: results from a national survey. Medical Journal of Australia, 185(2), 88.

X

Bates, D.W. and Gawande, A.A. (2003). Improving safety with information technology. New England journal of medicine, 348(25), 2526-2534.

X

Miller, R.A., Gardner, R.M., Johnson, K.B. and Hripcsak, G. (2005). Clinical Decision Support and Electronic Prescribing Systems A Time for Responsible Thought and Action. Journal of the American Medical Informatics Association,12(4), 403-409.

X

Aarts, J. and Koppel, R. (2009). Implementation of computerized physician order entry in seven countries. Health Affairs, 28(2), 404-414.

X

Ko, Y., Abarca, J., Malone, D.C., Dare, D.C., Geraets, D., Houranieh, A., ... and Wilhardt, M. (2007). Practitioners’ views on computerized drug–drug interaction alerts in the VA system. Journal of the American Medical Informatics Association, 14(1), 56-64.

Polypharmacy

X

X

X

X

Krska, J., Cromarty, J.A., Arris, F., Jamieson, D., Hansford, D., Duffus, P.R., ... and Seymour, D.G. (2001). Pharmacist‐led medication review in patients over 65: a randomized, controlled trial in primary care. Age and Ageing, 30(3), 205-211.

X

X

X

Vinks, T.H., Egberts, T.C., de Lange, T.M. and de Koning, F.H. (2009). Pharmacist-based medication review reduces potential drug-related problems in the elderly. Drugs & aging, 26(2), 123-133.

X

X

X

Hajjar, E.R., Cafiero, A.C. and Hanlon, J.T. (2007). Polypharmacy in elderly patients. The American journal of geriatric pharmacotherapy, 5(4), 345-351. Scanlin, A. (2013). Reducing the Risks of Medication Errors. BioSupply Trends Quaterly, 26-29.

X X

Meulendijk, M. (2012). Development of a decision-support system in the primary care sector. In CAiSE (Doctoral Consortium).

X

X

X

X

Meulendijk, M., Spruit, M., Drenth-van Maanen, C., Numans, M., Brinkkemper, S. and Jansen, P. (2013). General practitioners’ attitudes towards decision-supported prescribing: An analysis of the Dutch primary care sector. Health informatics journal, 19(4), 247-263.

X

X

X

X

X

X

Horn, J.R., Gumpper, K.F., Hardy, J.C., McDonnell, P.J., Phansalkar, S. and Reilly, C. (2013). Clinical decision support for drug-drug interactions: Improvement needed. American journal of health-system pharmacy: AJHP: official journal of the American Society of Health-System Pharmacists, 70(10), 905-909.

X

Mille, F., Degoulet, P. and Jaulent, M.C. (2007). Modeling and acquisition of drug-drug interaction knowledge. In Medinfo 2007: Proceedings of the 12th World Congress on Health (Medical) Informatics; Building Sustainable Health Systems (p. 900). IOS Press.

X

Ahearn, M.D. and Kerr, S.J. (2003). General practitioners’ perceptions of the pharmaceutical decision-support tools in their prescribing software. The Medical Journal of Australia, 179(1), 34-37.

X

Smithburger, P.L., Buckley, M.S., Bejian, S., Burenheide, K. and Kane-Gill, S.L. (2011). A critical evaluation of clinical decision support for the detection of drug-drug interactions. Expert opinion on drug safety, 10(6), 871-882.

X

X

X

continued on following page

783

STRIPA

Table 2. Continued Drug-Drug Interaction

Reference

E-Health

Seidling, H.M., Phansalkar, S., Seger, D.L., Paterno, M.D., Shaykevich, S., Haefeli, W.E. and Bates, D.W. (2011). Factors influencing alert acceptance: a novel approach for predicting the success of clinical decision support. Journal of the American Medical Informatics Association, 18(4), 479-484.

X

Drenth-van Maanen, A.C., van Marum, R.J., Knol, W., van der Linden, C.M. and Jansen, P.A. (2009). Prescribing optimization method for improving prescribing in elderly patients receiving polypharmacy. Drugs & aging, 26(8), 687-701.

X

Duerden, M., Avery, T. and Payne, R. (2013). Polypharmacy and medicines optimisation.

X

Health Care Specialists

Polypharmacy

X

X

X

X

Albrecht, U.V. (2012). Transparency of health-apps for trust and decision making. Journal of medical Internet research, 15(12), e277-e277.

X

Kaushal, R., Shojania, K.G. and Bates, D.W. (2003). Effects of computerized physician order entry and clinical decision support systems on medication safety: a systematic review. Archives of internal medicine, 163(12), 1409-1416.

X

Bindoff, I.K., Tenni, P.C., Peterson, G.M., Kang, B.H. and Jackson, S.L. (2007). Development of an intelligent decision support system for medication review. Journal of clinical pharmacy and therapeutics, 32(1), 81-88.

X

X

X

X

Meulendijks, E. A. (2013). Requirements Engineering for Medical Consumer Applications.

X

Medication Review

X

X X

X

Table 3. App comparison Features Overview conditions patient

STRIPA

Epocrates

a

Overview diseases patient

a

a*

Overview lab results patient

a

a*

Overview medication patient

a

a

Linking medication to the diseases

a

Advice start new medicine

a

Advice stop current medicine

a

Drug-drug interactions

a

Advice about medication dosage

a

Information about other health care professionals

a

a

a

Costs

Unknown

Rating

Unknown

784

a a

a

General drug information

a

a*

Pill identification based on its imprint and physical characteristics

* This is a premium only feature.

MicroMedex Drug Information

a

Free version or a premium version for $159.99 a year

$2.99 a year

Android: 4.3 (n = 19.356)

Android: 4.2 (n = 56)

Apple: 3 (n = 46.934)

Apple: 2 (n = 176)

785

Chapter 39

Performance of ServiceOriented Architecture (SOA): Medical Image Systems for Chronic Diseases Deepika Dubey Uttarakhand Technical University, India Deepanshu Dubey IIFM Bhopal, India Uday Pratap Singh Madhav Institute of Technology and Science, India

ABSTRACT A service-oriented architecture is combination of services having different platforms for implementation. These services are combined, used by, and communicate with each other. The communication is done by massage or data passing. Communication is done by interacting with each other based on different platforms. Chronic diseases are long-term illness that require observation with heavy treatments by the doctors and special attention by family members. Chronic diseases are Alzheimer’s disease, Addiction, Autoimmune diseases, Blindness, Rheumatoid arthritis, Chronic renal failure, Chronic Kidney Disease, Deafness and hearing impairment, Hypertension, Mental illness, Thyroid disease, Blood Pressure abnormalities.

INTRODUCTION A service-oriented architecture explain by Krafzig et al. (2005) is a service oriented application of the integration of multiple platforms. It is the newly introduced term for cross-application integration. This architecture promises to solve the big business services using its integration method of multiple platform designed in similar set of standards. This becomes possible through the inter communications between DOI: 10.4018/978-1-5225-7122-3.ch039

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Performance of Service-Oriented Architecture (SOA)

the different platforms without any intervention of humans. These can communicate by massage or data passing. Any application which is able to communicate with the other applications can be a part of this architecture.

What Is an SOA? 1. SOA is collection of independent type of services which is work perfectly when they all are combine systematically and used for different applications like business processes etc. Knorr and Rist. (2005) showed in their previous work that SOA is the combination of different services at different- different platform provide convenience to the users. 2. A Service Oriented Architecture deals with different way of services within an enterprise: a. The granularity and types of services. b. How services are constructed. c. How the services communicate with each other at different level. d. How the services are work together (i.e. orchestrated). e. How services contribute to IT and Business Strategy. It is based on the idea that it makes critical processes much simpler and easy to use within a single interface. In this research service oriented architecture is used to identify level (stage) of chronic disease by using 3D medical images. In this type of diseases long treatment is required having database either in hospital or collected by family members which are based on different type of medical reports. The work of Coffey et al. (2010) by using this database and using SOA we can easily diagnose disease and going for best treatment. For example, you visit on a webpage of a bank which is the homepage. Now you want to access your account by logging in using your username and password.

Integration of Service Oriented Architecture Knorr and Rist. (2005) showed in their previous work that an architectural based on services and technology based on integrating existing applications, these integration of services uses new Web services based on service platforms to a bus, not point-to-point.

Advantages of SOA Integration Approach 1. SOA Integrate a single time, and connect many nodes: a. Every time each system is integrated once for service bus, in compare of many time the same connection connected number of the times. b. Cost is very less, homogenous access. 2. Modified higher level business: a. Integrate small level operations from business services that adjust with the goals of services oriented architecture and strategy, compare to the old systems. b. Time to time SOA construct high-level, high-value business agendas from the business services in response to new initiatives, comparative pressures, and controlled changes. 3. Flexibility: a. Many services can be easily constructed on different platforms from the existing applications.

786

 Performance of Service-Oriented Architecture (SOA)

4.

5. 6. 7. 8. 9.

b. New processes can be constructed. c. Business Processes change time to time easily. d. Operational Systems are difficult, costly and slow to change. e. Operational systems are change or replaced by the new one. Incremental Approach for SOA: a. Start initially from small scale. b. Add new type of services like integration services, business services and processes over time, as part of specific projects, for response to particular business needs. c. Flexibility and capabilities increase for new type of launching services with each new service. Integration services provide interface to existing application. Interface granularity influenced by existing applications. Synchronous Invocation is common. ACID Transactions may be required. Unprotected directly to business services: a. Enveloped by business services or other services. b. Not exposed internal structure, data models and networking topology. c. Enhance, Elaborate, modify or combine previous functionality.

The Authentication process author De Pauw et al. (2005) explain supposes want to needs to connect to the bank server to know about the costumer’s details. Now there is need to make a transaction within your bank or you wish to make IMPS, RTGS or any other service want to access. With the help of online portal of your bank account, for the security reasons bank will send an OTP (one-time password) to your mobile number registered with your bank account. For performing this operation, the server needs to connect with the service provider for SMS service. Gaoyun Chen et al. (2010) All this process requires a large integration of different applications able to communicate with each other and it is fully automated. This is what SOA promises. SOA is the solution to making two software’s communicate with each other. In one side human as a user and on different side software is present to solve the query of the user. This type of implementation is used in any way. In SOA different types of web services are used for further processing. SOA is work on loosely coupled system having different CPU and storage memories but they are connected with each other to solve a particular task. SOA used in java, .net, as well as windows SOA type architecture.

Service-Oriented Architecture (SOA) History Service Oriented Architecture (SOA) is not a new approach. It is used till 1980 but not to be familiar by the maximum number of users it was used by selected numbers of experts. Author Krafzig et al. (2005), Knorr & Rist. (2005) and Halle (2010). 1. Many Successful SOA applications have been developed in the previously: SOA is having so many applications in every practical fields. And the different practical applications are invented previously not new development by the developer. 2. CORBA (Wells Fargo, Credit Suisse): The Common Object Request Broker Architecture (CORBA) is a standard which is based on the Object Management Group (OMG) W. De Pauw et al. (2005) designed for the communication purpose. CORBA merge collaboration between the systems on

787

 Performance of Service-Oriented Architecture (SOA)

Figure 1. Four P-model of service-oriented architecture (SOA)

http://saiaminfosoft.com/service-oriented-architecture-soa.html

different operating systems, programming languages, and computing hardware units. CORBA uses an object-oriented model (OOM) that uses CORBA which not have to be object-oriented. CORBA is an example of the distributed system. 3. Many, many more attempts at SOA failed: In Service Oriented Architecture more numbers of the attempts are failed due to service provided by the service providers. 4. But, can learn from what failed, and what succeeded: In Service Oriented Architecture everything is transparent with the help of Service Oriented Architecture learn many thing where the success is and where is the failure. Everything is clear to understand. Some IT developers think SOA is the concept related to “loosely coupled system” in theory but they don’t know how to use or to apply it in practical applications. Author Kevin Jackson (2008) explain about Service Oriented Architecture make change easier basically in software, hardware and network changes is difficult. Service Oriented Architecture is easy to assemble, easily reconfigure. Service Oriented Architecture service your business performance checking credit, checking inventory, checking shipping status etc. Service Oriented Architecture assemble any way you want (user friendly as well as flexible), save time and money, do something new, it also help to business grow and make changes easier.

788

 Performance of Service-Oriented Architecture (SOA)

Introduction to Enterprise Systems “Enterprise systems system is a set of integrated software modules and a common centralized database that data access or shared by many different business servers and functional areas with the help of the enterprise.” Enterprise systems are an Enterprise Resource Planning (ERP) system, used in many large organizations. Enterprise systems are always worked on large-scale; there are many difficult requirements in a crucial enterprise system: Availability The system is supposed to be always ready at any working point in time. Sometimes, there sudden increase in user demands to use that Enterprise system. Author Lublinsky (2007) and Cândido et al. (2010) if the system don’t capable to handle the load, result in a system down and can affect the company’s business and their also affect their marketing performance. Availability of enterprise system is difficult because the system help to be support 24x7 services and 365 days in a year. The last few years’ significant technology trends have been developed, such as Service Oriented Architecture (SOA) that provide an architecture for different services, author Cândido et al. (2011) & Papazoglou et al. (2007) Enterprise Application Integration (EAI) responsible for integration, Business-to-Business (B2B) deal with process with in businesses, and web services specify applications on web. These methods try to improve the results and escalating the value of integrated business processes. In case of Enterprise Service Bus (ESB) is the best way to get better performance. The ESB is a latest mechanism that provides integration this can be use in loosely coupled, and highly distributed integration network.

User Interface User interfaces related author explain De Pauw et al. (2005) and Balderrama (2010) about web Services refers to the way in which information may be displayed. Sometimes it also suggest from where the information is obtained for use. User interface specifications described on below mentioned sites. You can also neglect among the specifications by using of each page. Pressman and Lowe (2009) • • • • •

User Interface Markup Language (UIML). Web Services Experience Language (WSXL). Web Services for Interactive Applications (WSIA). Web Services for Remote Port lets (WSRP). Web Services User Interface (WSUI).

The key benefit of an Enterprise Service Bus is that it permits to diverse applications to talk with each other as a transit system for transferring data between different applications within enterprise or on web, Mule, is an example of lightweight runtime engine of any Platform. This is based on Java technology and act as an enterprise service bus (ESB). Author Eyermann et al. (2005) & Jones and Hamlen, (2011) it also provide integration platform that allow developers to connect different applications together speedily and simply. It also enables them to share data and easy integration of available systems, in spite of the different technologies that the applications use, like HTTP, JMS, and JDBC etc. The Enterprise Service Bus can be arranging anywhere; it can integrate and arrange events in real time or in batch fashion, and

789

 Performance of Service-Oriented Architecture (SOA)

has worldwide connection facility. Appropriate ESB selection is critical decision, when anyone wants to select ESB follow the following checklist:1. 2. 3. 4.

Number of application/services is 3 or more. Required to add more applications or services in the future? Required to use 2 or more communication protocol. Required routing capabilities for message.

An ESB is a platform that provide integration, it involve some standards in their process it combines messages, data transformation, different web services and provide route to connect and manage the communication of large numbers of different applications that are available across the enterprises.

SOA Used as Healthcare In growth of developing of modern technology and its functions which is used for different field The quick rise of technology in the field of healthcare which is developed and manage by healthcare organizations to provide appropriateness to the users of that not only need to work together within the organization, but are also accessed from outside the network also. Author Santiago et al. (2013) in this technology working is done with the help of integration on the users of the system, they are able to access many different systems to complete one task. The use of service oriented architecture (SOA) can improve the delivery of important information and do the sharing of data between the community of treatment cost, security, and risk of deployment. Healthcare organizations now a daycare challenged to manage an increasing portfolio of systems. Nguyenet et al. (2005) the price of acquiring, integrating, and preserving these systems are expanding too, while the trade of system users is expanding too. Organizations must locate to increasing clinical demands as well as support reward cycle and administration business behavior functions. In addition, demands are rising for interoperability with other organizations to regionally support care delivery. Service oriented architecture provides system design and management principles that support again use and sharing of system resources across the healthcare organization. SOA does not need the re-engineering of present systems. Author Georgas et al. (2005) With SOA, present processing can be combined with new capabilities to construct the services that are used as a part of solutions. Using differentiated services that are mapped with business processes, SOA become strong and understandability while decreases the need to synchronize data between autonomous systems. Services may be made available, no matter of their saved location, to create solutions that reach away from the desktop, the department, and the healthcare companies. A healthcare organization that are depends upon autonomous system from the whole system to support different department related to health care related to doctors, medicine and other health related issue and care handing over needs already has a solution that shares data with their patient and reuses system resources which is developed or maintained by healthcare organization. Hardion (2013) and Lacy (2014) More typical is an organization that depends upon one or more enterprise systems, supports departmentspecific needs with additional systems, has facilities that use their own doctors, own consultants system, and operates using a complex network of data interfaces. The organization that has a large database of systems more consciously sees the benefits of SOA. An SOA environment dynamite system directs to be operating around the organization, providing contiguous for sharing system capabilities that are

790

 Performance of Service-Oriented Architecture (SOA)

currently self-governing system. For example, SOA can help meet unfulfilled processing requirements without purchasing additional systems and can provide opportunities to normalize to develop and data administrations.

SOA Can Be Implemented in Healthcare A service-oriented architecture is having a huge range of applications because it allows and promises almost everything we can imagine having through network. Let us talk about its applications in healthcare and healthcare management system. Now a days as the population is increasing as a boom, we cannot imagine the hospital and the healthcare services like it used to be in 1950’s where the hospitals were totally mechanized, you had to make a line for getting registered in the entry register in the main hospital register and then after a long wait u got that opportunity to meet the doctor. After that u were supposed to repeat the whole process for your blood test getting done. Balderrama et al. (2010) You have to wait for many days and then you have to again come to the same place to collect your reports. After a huge investment of time, efforts and energy this process gets completed. Now a day’s market is moving in the next century and this century is known for IT revolution. We are now focusing on the artificial intelligence and developing our IT in such a way that it can change the way of doing work in every sense. We are now not willing to go to the hospital manually and waiting for our turn to come after many minutes and sometimes hours. Now we need to have an IT based smart system which can allow us to access all the functions and features of a medical institution through our figure tips. This can only be possible through the Service oriented architecture application in medical and health care. It can integrate almost everything (in terms of applications and services of different types) to make this possible. The diagram below shows what can be done using SOA in healthcare. Figure 2 shows the whole process of a hospital available under your fingertips. You can Register yourself with the Hospital through the online portal provided by the hospital and can make your account and you will have a username and password exclusive allotted for you. This account will increases for Figure 2. SOA can be implemented in healthcare

791

 Performance of Service-Oriented Architecture (SOA)

Figure 3. SOA can be help in Healthcare for doctor’s appointment

the further more communication to the hospital services as an authenticated and recognized costumer. This login account will also store all user important previous histories related to medical aid which are helpful for doctors as well as patients having a great feature, patient don’t need to carry the heavy and large files with them to show about treatment case history to the consulting doctors. Author Pizzi (2007) explain this will connect you to the database of the hospital every time you try to log in your account on hospital portal. It will also helpful to authentication of the patient whole time when doctor or patient try to log in medical account related to treatments securely of your personal data. Inside the account it can offer you many options of communication like real-time live chat through which you can enquire whatever you want and chat with the hospital person sitting other side. Patients can also book an appointment with their concerning doctor through the option present inside account without any trouble of gathering and no commission by the agents take by the agent of the hospitals. The work of author Lacy and Norfolk (2014) help us to understand healthcare in IT sector. In Figure 3, you can see the options provided by the hospitals to choose and book your doctor according to your priority and need. Scholl and Klischewski, (2007). SOA can promise the integration and implementation of every application you need to have. Every single gateway/window connects you to the next level in the hierarchy and provides you the services by many servers automatically. If you are a person from remote area and you or any of your family member is suffering from a disease which requires a continuous observation by your doctor. Your doctor is sitting in Delhi and it is not possible for you to go every now and then to his place. In this case SOA allows you to tele conference or video conference with your doctor. Lacy and Norfolk (2014), Eberhardt and Pamuk (2010) discuss in this research he is sitting in his place and you are at your home but with the help of SOA you can communicate with each other and can also share the video of the patient for the observation and improvement purposes. You can pay the fees of the doctor after the completion of the session using the payment gateway provided as the next step by the hospital authorities. SOA connects you to the bank gateway for the payment of fees in the doctor’s or in the hospital’s account. You can also order the medicines as prescribed from anywhere it are available online by choosing any payment option. This all can be done by the Service oriented architecture and it can make a significant difference for a person who is seriously I’ll or someone who is living in remote location.

Chronic Disease Chronic diseases are the disease from which a patient is suffering from those diseases from a long time. Required long treatment with cure and care

792

 Performance of Service-Oriented Architecture (SOA)

Alzheimer’s Disease Alzheimer’s disease is the most common cause of dementia. The word dementia describes a set of symptoms that can include memory loss and difficulties with thinking, problem-solving or language. These symptoms occur when the brain is damaged by certain diseases, including Alzheimer’s disease. Alzheimer’s disease, named based of the doctor name who first described it called Aloes Alzheimer, who fined that Alzheimer is a physical disease that mainly affects the brain. There are more than 530,000 people in the UK with Alzheimer’s disease. When a patient is fall off this disease, proteins develop in the brain to form structures which is called ‘plaques’ and ‘tangles’. Author Vaquero et al. (2009) This will causes the loss of connections between nerve cells to the brain, and in future cause of the dying of nerve cells and injuries of brain tissue. Persons with Alzheimer’s also have a shortage of some important chemicals in their brain. These chemical agents help to transfer the signals all around the brain. When there is a shortage of them, the signals are not transmitted as effectively. Alzheimer’s is a progressive disease. This means that gradually, over time, more parts of the brain are damaged. The symptoms of Alzheimer’s disease are normally slightly to start with, but they get horrible according to increase of the time. There are most of the common symptoms of Alzheimer’s disease, but it does not mean that every patient having same symptoms because don’t forget to remember that everyone is unique having different body mechanisms on this earth. Two patients effected with Alzheimer’s disease are unfortunately to experience the condition comparison in exactly the common way. For many people suffering from Alzheimer’s, the initial starting symptoms are memory lost. Specially, patients always have facing difficulty to recalling recent events and learning new information. These symptoms faced by the patient because in the starting stage damage in Alzheimer’s is usually to a part of the brain called the hippocampus, which play important central role in regular daily memory. Memory loss reasons are Figure 4. Alzheimer disease brain with healthy brain

http://www.healthylifebase.com/wp-content/uploads/2015/08/4-Steps-To-Prevent-Alzheimer%e2%80%99s-Disease.jpg

793

 Performance of Service-Oriented Architecture (SOA)

Alzheimer’s disease increasingly interferes with daily life as the stages progresses. Prevention Research Centers. Atlanta (GA) (2013) The person may: • • • • •

Lose accessories related to him/her daily life (e.g. keys, glasses) inside the house. Facing a lot of problem to find the correct words during conversation period or forget name of their near and dear ones. Blur images are formed in their memory about recent conversations or events. Get lost their memory related in a familiar journey. Forget appointments or anniversaries.

Addiction Addiction is a condition that results when a person continuously habitual to that substance (e.g., alcohol, cocaine, nicotine) or repeatedly in an activity without skip (e.g., gambling, sex, shopping) that can be enjoyable but the continued use of which becomes compulsive and interferes with ordinary life responsibilities, such as work, relationships, or health. It affects your social as well as professional life. Users may not be aware that their behavior is out of control and causing problems for themselves and others. The word addiction is used in different ways. One describes physical addiction. This is a biological state of your mind in which the body modifies to the presence of a drug so that drug no longer has the same effect, otherwise known as a resistance. Hartley (2010) Another form of physical addiction is the phenomenon of overreaction by the brain to drugs (or to cues associated with the drugs). An alcoholic person visited regularly into a bar, for instance, will need an extra support to have a drinking alcohol because of these addictions. Figure 5. Addiction disease explain circle http://www.amer-i-can.org/program/program.html

794

 Performance of Service-Oriented Architecture (SOA)

Addiction is a disease which is actually diseases cum habit which is adopted by their own choice of the patient at the starting and after some time it take a form of diseases which is not controlled neither by the patient nor by the doctor it is just a behavior issues, according to doctors; addictions categories like addiction to drugs, drink alcohol daily at large quantities, sex done in uncontrolled way, or eating disorders either take more or less food as required body need. “It’s a brain problem whose behaviors unambiguous in all these other areas. Addiction means not only patient suffer with this disease but the whole family suffer with this disease due to because of that family member.

Autoimmune Disease An autoimmune disease develops when human immune system, which defends your body against disease, decides by your healthy cells are foreign. As a result, your immune system attacks healthy cells. Based on the type of stage and body mechanism of the different humans which suffers with this disease, an autoimmune disease affects one or many different types of body tissue. It can also cause abnormal organ growth and changes in organ function. There are as many autoimmune diseases. Author Hartley (2010) explain mostly the patients are of common symptoms, which is complicated condition face by the doctors difficult to diagnose. Always it is not possible to have same symptoms or having different symptoms. Recently, treatment for autoimmune diseases focuses on relieving symptoms doing a lot of love and care during these diseases because there is no perfect therapy accepts a lot of care. Immune system of the humans produces antibodies (proteins that remember and damage the specific substances present in human body) Geert et al. (2007) against harmful intrudes in human body. These invaders include: viruses, bacteria, parasites, fungi.

Figure 6. An Autoimmune disease develops in human system http://www.cytherapharm.com/about.html

795

 Performance of Service-Oriented Architecture (SOA)

Because there are different types of autoimmune disease, the symptoms vary according to the human mechanism of the body. Autoimmune diseases affect different parts of the human body. Mostly organs and tissue affected in this diseases like: joints of bones, whole body muscles, skin of the body, red blood cells all over human body, blood vessels inside body etc. Autoimmune diseases are chronic disease with no perfect cure. Precautions are the best way to cure it. These are as follows: 1. 2. 3. 4. 5. 6. 7.

Eat a balanced and healthy diet. Exercise regularly. Get lots of rest. Take vitamin supplements. Decrease stress. Limit sun exposure. Avoid any known triggers.

Blindness Blindness is the disease in which human not capable to identify anything with the help of eyes i.e. eyes are not working. Blindness is the incapability to see anything, even light or any object in this world. If a patient is partially blind, have limited vision by the eyes. Blindness also called Visual impairment, also known as vision impairment or vision loss, is a decreased ability to see to a degree that causes problems. Author Hartley (2010) explain basically most common causes of blindness is visual connection globally like dissatisfied refractive, cataracts, and glaucoma Refractive errors include near sighted, far sighted, and astigmatism.

Figure 7. Anatomy of eyes

https://eyemakeart.wordpress.com/2009/06/20/human-eye-anatomy-description/

796

 Performance of Service-Oriented Architecture (SOA)

Rheumatoid Arthritis Rheumatoid arthritis (RA) is a chronic Disease which is autoimmune disorder that primarily affects joints. Bone joints affected by this Disease. It results in warm, swollen, and painful joints specially hands knees and leg joints. Rheumatoid arthritis (RA) affects only the 1% of adults in the whole world with if take an example of 100,000 people so only 1000 peoples are affected by this disease developing the condition and having different symptoms. Other diseases which belong to the same family of Rheumatoid arthritis (RA) present similarly having systemic, and fibromyalgia among others. D.S. Linthicum, (2010). Rheumatoid arthritis (RA) is a systemic, chronic self-protection autoimmune that primarily impacts the effect of joints.

Chronic Kidney Disease Chronic kidney disease (CKD), is also known as chronic disease, because patient I suffer with this diseases a long time having result continuously kidney loss function as the time increases (months or years). Healthy people 2020. Washington (DC): (2010) Kidney disease is identified by the doctors after blood for keratinize, or by urine test which is a breakdown product of muscle metabolism. 1. Blood pressure is increased because of kidney damage having risk of developing hypertension and increases the percentage of heart. 2. Urea ascites, leading to azotemia and ultimately uremia urea is removing in echini sweat at high concentrations and crystallizes on skin. 3. Potassium accumulates in the blood from lack of insulin. Figure 8. Comparison of normal joints with Rheumatoid arthritis

http://www.darwindietitians.com.au/food-is-the-real-trigger-of-rheumatoid-arthritis/

797

 Performance of Service-Oriented Architecture (SOA)

Figure 9. Chronic kidney disease with healthy kidney https://jeffreysterlingmd.com/tag/renal-failure/

4. 5. 6. 7.

Erythropoietin synthesis is decreased causing anemia. Fluid volume overload symptoms may range from mild edema. Hyper phosphatemia, due to reduced phosphate excretion. Hypocalcaemia, due to 1,25 die-hydro vitamin D3 deficiency.

Hypertension Hypertension is defined as blood pressure measures higher than 140 over 90 mmHg. Diagnose of hypertension find out when one or both (upper and lower) readings mentioned above are high (blood pressure reading): the blood pressure at which the heart pumps blood all around the human body. Healthy people 2020. Washington (DC): (2010) Today’s modern and busy lifestyle factors are responsible for a growing burden of hypertension: a) physical inactivity, b) salt-rich diets with processed and fatty foods, and c) alcohol and tobacco use. Busy lifestyle of humans calculated how to treat high blood pressure, Geelan (2008) including salt restriction causes high blood pressure containing sodium and other dietary (having related to milk) changes, intake of quantity of alcohol, and stress reduction due to over work load. Figure 10. -blood pressure a) Blood pressure measuring chart b) Chart follow to avoid hyper tension http://optimalwellnesslabs.com/what-you-really-need-to-know-about-high-blood-pressure http://www.klaruslightusa.net/2016/09/

798

 Performance of Service-Oriented Architecture (SOA)

Mental Illness Mental illness is also called mental disorder as it’s sometimes, affects the behaviors and the psychological patterns of an individual humans. Vaquero et al. (2009) The causes of mental disorders are always unclear. Mostly major categories of mental illness are as following: • • • • • • • • • • • •

Anxiety Disorders. Bipolar and Related Disorder. Disruptive, Impulse-Control, and Conduct Disorders. Dissociative Disorders. Feeding and Eating Disorders. Neuro cognitive Disorders. Neuro developmental Disorders. Personality Disorders. Sleep-Wake Disorders. Somatic Symptoms and Related Disorders. Substance-Related and Addictive Disorders. Trauma and Stressor-Related Disorders.

Mental disorders are basically defined by a combination of a person behaves, feels, become aware or conscious of, or thinks. This may be related with particular regions or functions of the brain, which comes in social contact.

Thyroid Disease A thyroid disease is a medical condition connected with the function of the thyroid. Different categories in which doctors categories thyroid diseases which are Hashimoto’s thyroiditis, hyperthyroidism and hypothyroidism. Author Hartley (2010) these diseases have a large range of symptoms and affect all ages.

CONCLUSION A service-oriented architecture is combination of services having different platforms for implementation. These services are combined, used by communicate with each other. The communication is done by massage or data passing. Communication is done by interacting with each other based on different platforms. Chronic diseases are the long time illness required quit observation with heavy treatments by the doctors and special attention by family members. So, by using SOA patient consult with the doctors with fast treatment. In case of chronic diseases doctors aware to patient conditions so they solve problem through this service every time no need to visit doctor’s clinic or hospital.

799

 Performance of Service-Oriented Architecture (SOA)

REFERENCES Balderrama, J. R., Montagnat, J., & Lingrand, D. (2010). jGASW: A Service-oriented framework supporting HTC and non-functional concerns. In Web Services (ICWS), 2010 IEEE International Conference, (pp. 691-694). Cândido, G., Colombo, A. W., Barata, J., & Jammes, F. (2011). Service–oriented infrastructure to support the deployment of evolvable production systems. Industrial Informatics. IEEE Transactions on, 7(4), 759–767. Chen, G., Lu, J., Huang, J., & Wu, Z. (2010). SaaS - The Mobile Agent based Service for Cloud Computing in Internet Environment. Sixth International Conference on Natural Computation, ICNC 2010, IEEE Yantai, Shandong, China, (pp. 2935-2939). 10.1109/ICNC.2010.5582438 Coffey, J., White, L., Wilde, N., & Simmons, S. (2010) Locating Software Features in a SOA Composite Application. Eighth IEEE European Conference on Web Services, ECOWS’10, (pp. 99-106). 10.1109/ ECOWS.2010.28 De Pauw, Lei, Pring, Villard, Arnold, & Morar. (2005). Web Services Navigator: Visualizing the execution of Web Services. IBM Systems Journal, 44(4), 821-845. Eberhardt, M.S, Pamuk. (2010). E.R. The importance of place of residence: Examining health in rural and nonrural areas. American Journal of Public Health, 168–176. Eyermann, F., Racz, P., Stiller, B., Schaefer, C., & Walter, T. (2005) Service-oriented accounting configuration management based on diameter. In Local Computer networks, 2005. 30th Anniversary. The IEEE Conference,(pp. 621-623). Geelan, J. (2008). Twenty one experts define cloud computing. Virtualization, Electronic Magazine. Geert, Vanderhulst, Kris, Luyten, Karin & Coninx. (2007). Middleware for Ubiquitous service-oriented spaces on the web. AINAW, (vol. 2, pp. 1001-1006). Halle, S., Bultan, T., Hughes, G., Alkhalaf, M., & Villemaire, R. (2010). Runtime Verification of Web Service Interface Contracts. Computers & Society, 43(3), 59–66. doi:10.1109/MC.2010.76 Hardion, V., Spruce, D. P., Lindberg, M., Otero, A. M., Lidon-Simon, J.,Jamroz, J. J. (2013) Press on, A Configuration Management of the control system. THPPC013. Hartley, D. (2010). rural health disparities, population health, and rural culture. American Journal of Public Health, 167–178. PMID:15451729 Jackson. (2008). Cloud Computing Related Technologies and their Use in the Public Sector to Support Net-centric Operation. Academic Press. Jones, M., & Hamlen, K. W. (2011). A service-oriented approach to mobile code security. Procedia Computer Science. Knorr & Rist. (2005). 10 steps to SOA in Info World. Computer Society of India San Mateo.

800

 Performance of Service-Oriented Architecture (SOA)

Krafzig, D., Banke, K., & Slama, D. (2005). Enterprise SOA Service-oriented architecture best practice. Indianapolis, IN: Prentice Hall Professional Technical Reference. Lacy, S., & Norfolk, D. (2014). Configuration Management: Expert guidance for IT service managers and practitioners (Revised edition). BCS. Linthicum, D. S. (2010). Cloud Computing and SOA Convergence in Your Enterprise. Addison-Wesley. Lublinsky, B. (2007). Defining SOA as an architecture style. IBM Developer Works. Nguyen, T. N., Munson, E. V., Boyland, J., & Thao, C. (2005) an Infrastructure for Development of Multi-level, Object-Oriented Configuration Management Services. In Proceedings of the 27th International Conference on Software Engineering, (pp. 215-224). Papazoglou, M. P., Traverso, P., Dustdar, S., & Leymann, F. (2007). Service-Oriented Computing state of the art and research challenge. IEEE Computer, 40(11), 38–45. doi:10.1109/MC.2007.400 Pizzi, S. V. (2007) A routing architecture for the airborne network. In Military Communications Conference, (pp. 1-7). 10.1109/MILCOM.2007.4455108 Pressman, R. S., & Lowe, D. B. (2009). Web engineering: a practitioner’s approach. McGraw-Hill Higher Education. Santiago, I., Vara, J. M., Verde, J., de Castro, V., & Marcos, E. (2013). Supporting Service VersioningMDE to the Rescue. In ENASE, (pp. 212-217). Scholl & Klischewski. (2007). E-Government Integration and Interoperability: Framing the Research Agenda. International Journal of Public Administration, 30(8-9), 889–920. doi:10.1080/01900690701402668 Vaquero, L. M., Merino, L. R., & Caceres, J. (2009). A break in the clouds: Towards a cloud definition. Computer Communication Review, 39(1).

This research was previously published in Exploring Enterprise Service Bus in the Service-Oriented Architecture Paradigm edited by Robin Singh Bhadoria, Narendra Chaudhari, Geetam Singh Tomar, and Shailendra Singh, pages 327-343, copyright year 2017 by Business Science Reference (an imprint of IGI Global).

801

Section 11

Spending and Economics

803

Chapter 40

The Economics of Long-Term Care:

Key Concepts and Major Financing and Delivery Models Peter P. Yuen The Hong Kong Polytechnic University, Hong Kong

ABSTRACT This chapter presents key concepts of economics relevant to the financing and delivery of long term care services. It first examines the magnitude of population aging in developed economies, and the associated implications for long term care. Key economic concepts relating to the demand, supply and financing of long term care services are then discussed. Policies, practices and major models of financing of long term care are further explored followed by a presentation of the conceptual framework for reform. It concludes that in view of the magnitude of the problem, incremental changes in the existing systems are unlikely to be adequate. A clear understanding of the economic concepts to underpin major transformation of existing systems and policies that do not align with populations trends is urgently needed.

INTRODUCTION Economics is “the study of how men and society end up choosing…to employ scarce productive resources that could have alternative uses to produce various commodities and distribute them for consumption…. It analyses the costs and benefits of improving patterns of resource allocation” (Samuelson 1976). The economics of long term care, therefore, refers to the use of economic concepts, theories and tools to analyze how resources are allocated in the financing and delivery of different types of long term care services, as well as how they should be reallocated to achieve more desirable outcomes. Long term care (often also referred to as social care or aged care) consists of a mix of services to assist an impaired person to function in activities of daily living (ADL), include bathing, transferring, toileting, and dressing, as well as incidental activities to daily living (IADLs), which include cooking, DOI: 10.4018/978-1-5225-7122-3.ch040

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 The Economics of Long-Term Care

housekeeping, moving around, and managing personal finances (Spector & Fleishman 2001). It does not include the medical care that the impaired person requires. Long term care covers both community services and residential services. Community services include services delivered to the home of the individual (such as home-helpers’ services, visiting nursing services), and services provided at day care centres. Residential services include a range of residential facilities depending on the severity of disability (such as self-care homes, care and attention homes, nursing homes and infirmaries) (Yuen 2014). The care is generally provided over a long period of time, and often until death. While the unit cost of care is relatively low compare to acute care, the total cost of care can be very high in view of the high number of persons requiring care and the fact that it is necessary to provide care over a long period of time. This chapter first examines the magnitude of population aging in developed economies, and the associated implications for long term care. Concepts and issues relating to the demand, supply and financing of long term care services are then discussed. Policies, practices and major models of financing as well as a conceptual framework for reform are presented towards the end.

BACKGROUND As a result of longer life-expectancies, the elderly population is rising at a speed, which is unprecedented in the history of mankind. It is a global phenomenon affecting every country and region, with industrialized economies experiencing the highest ageing growth rate at the present time. The share of the population aged 80 years and over is expected to more than double in coming decades across the OECD, growing from 4% in 2010 to close to 10% by 2050 (Colombo & Mercier, 2011). This ageing process is widespread and enduring, because of the ubiquitous and sustaining nature of the trend of longer life expectancies and lower fertility rate of developed economies. The world is not likely to return to the kind of age structure that the previous generations experienced (United Nations Population Division, 2001). Associated with ageing is the increasing need for long term care for a significant percentage of the elderly population. Long term care expenditure has been on the increase for most countries, and is expected to increase at a much greater rate in the coming decades. In the USA, it was estimated that 25% of its population age 65 and above requires some form of long term care (Feldstein). In the United Kingdom it was found that while, on average, people could expect to live to age 77, 15 of these years would be spent with some form of disability (WHO, 2015). In Australia, it was found that three quarters of the elderly persons who died used some form of long term care during the twelve months before death, and around half of them used long term care services more than four years before death (Australian Institute of Health and Welfare 2015). In Hong Kong, it has been projected long term care spending will increase from 1.4 percent of GDP (in 2011) to 3 percent of GDP by 2036, with an average growth rate of 3.1% (Chung et al, 2009). A very significant form of disability relating to aging is dementia. In 2015, dementia affected more than 47 million people worldwide. By 2030, it is estimated that more than 75 million people will be living with dementia, and the number is expected to triple by 2050. In one Australian study, it was estimated that around 10% of the expected increase in health-care costs during the next 20 years would come from demand for care for this condition alone (Vos, Goss, Begg & Mann, 2007; WHO, 2015) While the notion that longer life expectancy inevitably translates into higher health care expenditure is challenged by some – some studies indicate that expenditures for the 65-74 age group for hospital care

804

 The Economics of Long-Term Care

as well as for outpatient visits actually fell (Oliver, Foot & Humphries 2014, Kingsley 2015, Rolden, van Bodegom & Westendorp 2014) -- few would dispute that long term care expenditures will increase as the population ages. A clear understanding of the economics of long term care is therefore essential in formulating appropriate strategies to tackle this serious problem.

KEY CONCEPTS RELATING TO THE ECONOMICS OF LONG TERM CARE The following sections examine a number of commonly used economic concepts and apply them to the long term care sector. Concepts relating to demand and supply are first examined. Financing and payment systems are then explored, follow by analyses of major financing models and the conceptual model for financing reform.

Demand for Long Term Care The term “demand” is often used liberally in everyday life which may or may not mean the same as the economic term. Three related concepts --“Needs”, “Wants”, and “Demand” -- for services are elaborated below within the context of both institutional and community-based long term care.

Needs “Needs” are professionally defined, generally refer to the quantity of a particular service which health care professionals believe ought to be consumed. For long term care, there are generally accepted measurements to determine the degree of impairment a person suffers in carrying out ADL and IADL in determining the need for a particular type of service. There are assessment tools to measure the patient’s functional performance, sensory performance, mental health, continence, communication, behavioural symptoms, mood symptoms, pain symptoms, pressure ulcers etc. (Lou et al, 2011). Commonly used measurements include: • •

• • •

Barthel Index (BI): Measures the level of independence in daily activities, including personal hygiene, bathing, feeding, toileting, mobility, bowel control, and bladder control (Mahoney & Barthel, 1965; Collin et al, 1988); Instrumental Activities of Daily Living Index (IADL): Assesses the level of dependency of an elderly person on more complex daily living activities, including the ability to prepare meals, take medication, communicate with others, do laundry, perform housekeeping tasks, do grocery shopping, handle finances etc (Lawton & Brody, 1969; Tong & Man, 2002); Time Up-and-Go Test (TUG) and Elderly Mobility Scale (EMS): Measures basic mobility, which is a commonly used predictor of functional dependence (Cheung, Au, Lam and Jones, 2008, Yu; Chan & Tsim, 2007); Norton Scale: Assesses risk for pressure sore development (Norton et al, 1979); Berg Balance Scale (BBS) and Morse Fall Scale (MFS): Measures balance impairment and can be used to predict the risk of fall (Berg et al 1992, Morse et al 1986);

805

 The Economics of Long-Term Care

• •

Mini-Mental State Examination (MMSE): Assesses cognitive impairment, covering time/ place orientation, attention, short-term memory, language etc and is often used to assess dementia (Folstein et al, 1975); Geriatric Depression Scale (GDS): Screens elderly persons for depressive symptoms (Yesavage et al, 1983).

These types of assessment are often carried out to determine the type of services needed and/or the eligibility to receive benefits either in kind or in cash. It is important that public financial support should be targeted where the need is the highest. The basket of subsidized services should strategically address users’ needs and cost-effectiveness considerations. Benefits should be tied to the need-level. Patients with cognitive impairment, for example, should be given high priority because of the intensity of care required.

Want “Want” refers to the quantity of service which the patient and/or his family would like to consume at zero price. “Wants” tend to vary from one population to another because of cultural or other reasons. What may be deemed to be “needed” by professionals may or may not be wanted by consumers. On the other hand, what may be deemed as unnecessary by professionals could be “wanted” by the consumer. For example, based on an objective assessment of the patient’s condition, health care professionals may decide that the patient should be best cared for at home or on at a day care centre, but family members might still “want” the patient to continue to stay in a hospital. This is quite common, as hospital care is often heavily subsidised by government or paid for by insurance, whereas caring for the patient at home or at a day care centre is not, or the government subsidy is not as generous (Chee & Phua, 2016). Apart from the payment issue, some family members do not “want” to assume the responsibility to care for the patient at home, even though the patient’s disability could be mild and “need” not go to a residential facility. “Need” is often assessed by asking consumers whether or not they want the service (often without indicating to them the price or the full cost of the service) through questionnaire survey. Politicians sometimes survey residents in their constituency and asked them if they would like government to open a particular type of care facility in their neighbourhood. Signature campaigns for a particular type of service by pressure groups are also manifestations of “want”.

Demand “Demand” is an economic term – the quantity that consumers are willing to consume at a given price. It is related to but not synonymous with “need’ or “want”. It is dependent on price (own price and price of substitutes), as well as the income and taste of the consumer.

Price The impact of price on demand is affected to a large extent by its elasticity. A service that is highly price elastic implies that a small change in either its own price or the price of its substitute will result in a big change in the quantity demanded. On the contrary, a service that is price inelastic means that changes in its own price or the price of its substitute will have little impact on the demand. Less skilled

806

 The Economics of Long-Term Care

long term care services (for example, bathing, toileting etc) for the less dependent elderly are generally more price elastic than more skilled care required for the more dependent elderly. Coverage by long term care insurance will reduce the price at the point of consumption for users and hence will impact significantly on demand. The price of substitutes also affects demand. Different co-payment rates for different types of long term care service can drive demand from one type of care to another. For example, day care and home care are substitutes for residential care for many elderlies. In an attempt to encourage greater use of day care and home care services, many countries are now requiring higher copayment for residential care and at the same time providing free non-residential care services. In Hong Kong, because a high percentage of residential care are heavily subsidized by government and community based services are not, the percentage of elder persons in residential facilities is much higher than those receiving community based care as well as those in neighouring countries like Japan and Singapore (Chiu et.al 2009). The demand for voluntary long term care insurance also tends to be highly price elastic. Take-up rate is generally much higher if there are government subsidies or tax incentives to defray part of the premium expenses.

Income Given a same price level, demand can also vary as a result of the income of the user. Similar to the case of price, the impact of income on the demand for a particular type of long term care service is dependent on the elasticity of the demand. Long term care services are generally income elastic. High income families are generally more likely to purchase services that enhance comfort for the patient and convenience for family members, whereas lower income families often will have to forgo them, and rely more on free care provided by family members.

Taste Factors other than price and income that affect demand are collectively known as “taste”. This generally refers to cultural norms and lifestyle preferences. In some cultures, for example, sending your frail elderly parents to a residential old age home is a norm, while in some cultures it would be considered unfilial to do so. The propensity of a population to purchase insurance is another example that will affect the demand for long term care insurance. Risk-avoidance culture tend to have a higher percentage of population buying voluntary insurance than population in a risk-taking culture (Yuen 1992)

SUPPLY OF LONG TERM CARE Long term care services can be roughly divided into non-residential services and residential services. Non-residential services include services delivered to the patient’s home (home-based care), care provided at day care centers (day care), and integrated programmes (Lou, Kwan & Chan, 2011). As for residential services, there are different types of facilities depending on the severity of the disability, and can be grouped under the following major categories (in order of the impairment levels of the resident): hostels and homes for the elderly; care and attention homes; nursing homes; infirmaries; and hospices (Chung et al, 2009). Non-residential services generally cost less than residential services, and are gener-

807

 The Economics of Long-Term Care

ally considered better for the patient. For non-residential services to be more effective, some countries have formal programmes to integrate them with primary health care services, targeting people at low risk of death, enabling patients to stay at home and yet receive all the necessary care and treatment in the community (Atun, 2004; Chappell et.al, 2004; Stuck et.al, 2002; WHO, 2015; Lou, Kwan & Chan, 2011; Chin & Phua, 2016). Delivery entities for long term care services include government units, quasi-nongovernment organizations (QUANGOs), not-for-profit non-governmental organizations (NGOs), private for-profit organizations and informal carers. Direct provision by government units are less common these days, and provision by NGOs seems to be the general trend. Provision by private for-profit operators is common is some countries – in Japan, over 40 percent of home care is provided by private for-profit providers (Chin & Phua, 2016). Informal carers, mostly family members, with or without the assistance of domestic helpers, are always very important providers of care in most countries. Similar to demand, supply is affected by price and price elasticity. Inelastic supply means that a big increase rise in price results only in a small increase in the quantity supplied. An inelastic supply is therefore highly undesirable. An understanding of factors affecting supply elasticity is important. Major factors affecting supply elasticity for long term care services include: manpower, land, capital, and local legal requirements.

Manpower The workforce for long term care comprises of a wide spectrum of individuals, ranging from unpaid, untrained informal carers (often family members) to the highly trained, highly paid formal professional carers. Manpower shortage is a common problem hindering the supply of adequate places in long term care facilities.

Formal Carers For formal carers, the existing service care model for most countries tends to be highly “acute care-centric”, in terms of the training as well as job opportunities of the formal care providers (Woo, 2007). Training programmes for doctors, nurses and allied health professions all tend to put emphasis on acute inpatient care, resulting in silos of highly specialized professions all wanting to work in the acute care sector. The compartmentalized arrangement for health care vs long term care in many countries often lead to inability of long term care agencies to recruit adequate number of nursing and allied health staff to their facilities, as well as to frequent loss of qualified staff to acute care facilities because of the lack of promotion prospect in these agencies for these professional staff. The lack of medical staff in long term care facilities have also resulted in frequent visits to high cost hospitals’ accident and emergency departments and hospital admissions of residents from long term care institutions. The strict division of labour among the different types of health care professionals and their inpatient focused training further aggravate the elderly care manpower problem (Yuen, 2014). There is an urgent need to move away from the current “acute care-centric” and “institutionalization focused” system (Woo, 2007) to a patient oriented, community based, holistic and multitasking approach (Atun, 2004; Chu & Chi, 2006; Coulson et al., 2000) in basic training as well as in-service development of knowledge and skills for service providers. A training project for home care staff in London has found

808

 The Economics of Long-Term Care

that a bottom-up approach, focusing not purely on clinical knowledge, but more on interactions between staff, patients and families, quality of life and emotion of the clients and their families issues is more appropriate (Cooper et al, 2009; King, 2012).

Informal Carers While everyone agrees that enabling elderly to “age in place” in their homes with support of their family members is most desirable, the fact is that in most developed countries, because of low fertility rates and other social factors, the number of younger family members able and willing to care for their elderly parents continue to shrink. Informer carers often faces a great deal of stress and do not receive much support from their government (Kua, 1997; Metha, 2005). Many countries have resorted to the employment of foreign domestic helpers to provide care for the elderly in their homes (Yeo & Huang, 2009).

Land In urban areas, high land price is often a major barrier for the supply of long term care facilities, especially for commercial operators. Some governments grant land at reduced or nil premium to nonprofit NGOs delivering long term care services. Apart from hindering the supply of places, high cost of space can also affect quality of care, particularly residential care. High land price also results in many families having to live in very crammed space, which also renders caring for their elderly members at home difficult.

Capital The lack of startup capital is a common problem for NGOs. In Japan, for example, shortly after the implementation of long term care insurance, there were not enough long term care facilities even though funding was available for families to purchase the care (Ichien, 2000). To mitigate this problem, the Singaporean government has schemes (Community Silver Trust and Eldercare Fund) which provides grants to NGOs wanting to provide long term care services in the community (Ministry of Health, 2000, 2012). In many other countries, it is not uncommon to find that there are more than one government bodies to oversee both health care and long-term care. In Hong Kong, for example, the funding of health care services comes from the Food and Health Bureau and the funding for long-term care services comes from the Labour and Welfare Bureau. It is difficult to divert resources from the relatively well funded acute health care sector to the less well funded long-term care sector to tackle some obvious problems such as the early discharge of elderly patients, who stay at acute hospitals inappropriately (Yuen, 2014).

Local Legal Requirements Laws and regulations governing long term care facilities and manpower can affect the supply elasticity for long term care. Stringent requirements on the operators and facilities can deter or hinder the supply of services. Stringent requirements on training programmes for health care professions can also have an adverse effect.

809

 The Economics of Long-Term Care

LONG TERM CARE FINANCING A country/region’s long term care financing can be broadly described by the following equation: T + CI + VI + OPP + FF = P*Q where T stands for taxes. It includes general taxation, special taxes and levies. CI stands for compulsory long term care insurance. VI stands for voluntary long term care insurance. OPP stands for out of pocket payment by users, mainly from personal savings. It includes current and fixed assets of the patient. FF stands future fund of the government. It included all kinds of investment tools set up by government to secure stable returns for the future to mitigate the impact of population ageing. P stands for price of service. Q stands for quantity of service. Components on the left hand side of the equation are sources of fund to finance long term care. Components on the left hand side of the equation represent how the funds are being used. Long term care financing reform involves changing the weighting of different components in the equation. Elaborations on each of the components are provided below.

Tax This includes all forms of government general revenue, such as income tax, sales tax, special taxes, and different types of levies. Tax is generally a very important source of financing for long term care services, even for countries with mandatory long term care insurance. In some countries, tax revenues are used to build facilities and to subvent services from NGOs. In countries with compulsory long term care insurance, tax revenues are often used to subsidise the insurance so as to keep the premium low, as well as to pay for the premium of the unemployed and those in low income. The reliance on taxation to pay for long term care services is highly problematic for most countries with an ageing population, as revenue from direct taxation normally declines with a shrinking working population. Some form of tax broadening might be necessary by levying special taxes on either individuals or businesses to help pay for the ever increasing long term care expenses.

Compulsory Long Term Care Insurance This is either a part of the mandatory social insurance, or a standalone government programme, requiring all working adults or only those reaching a certain age (such as 40 years old in Japan) to participate. A certain percentage of a person’s income is deducted to go into a central insurance fund. In the event of disability, long term care expenses will be covered in part or in full by the insurance after assessment. Similar to tax, revenue from premium diminishes with an aging population, requiring a constant increase in premium rate for the working population, creating problems of intergeneration equity.

810

 The Economics of Long-Term Care

A variant of compulsory long term care insurance is savings-insurance arrangement, in which working adults are required to contribute a percentage of income to a long term care savings account. Upon reaching a certain age, 65 for example, the balance, in part or in full, will be used as a lump payment for long term care insurance for the individual (The Harvard Team, 1999). This arrangement migrates the problem of intergeneration equity, as each elderly person carries with him/her accumulated savings as contribution to the insurance premium.

Voluntary Long a Term Care Insurance Voluntary private long term care insurance is generally available in most countries. In the event of disability, benefits will be paid out in the form of either a lump sum or reimbursement for services up to a certain amount after assessment. Premium can also be paid annually or in form of a lump sum, depending on the plan. However, for various reasons, the market for voluntary private long term care insurance is small in most countries. In OECD countries, long term care expenditure paid by private insurance is less than two percent of total long term care expenditure (OECD, 2011a), and in the USA, where private insurance is so common, it is still less than four percent (Brown & Finkelstein, 2007).

Out of Pocket Payment/Co-Payment This refers to users fees, charged to patients either on a partial or full cost recovery basis. Patients’/ families’ income and savings, included current and fixed assets, are the sources for such payment. Most systems require some cost-sharing on long term care benefits. Almost no long term care system is entirely free. In USA, out-of-pocket payment accounts for one-third of total long term care expenditure, which is very significant (Brown & Finkelstein, 2007). The rate of copayment can be linked to income as well as to needs. In France, for example, a long term care cash benefit pays up to €1,235 per month for a high-need/low-income user, but only €27 per month for the highest- income users, while in Sweden there is a cap for cost-sharing on home-help services of €180 per month. Paying higher benefits to low-income dependents as in France and other countries ensures access to care for those who need it without excessive public expenditures (Colombo and J Mercier 2011). Paying for long term care using fixed asset of the patient is becoming more common. There are a number of possible mechanisms to help users with low and moderate incomes but have accumulated assets to turn some of these assets (for example, a house) into cash to pay for such expenses. An example from Ireland is the Irish Nursing Home Loans under which a resident can defer to the time of his or her death their nursing home contribution set on the basis of the value of their non-financial assets, such as their home (Colombo & Mercier, 2011).

Futures Fund This is a form of pre-funding or a collective savings account (Savings Working Group Final Report to the Minister of Finance, 2011) whereby government set aside some funds to pay for future obligations. Some futures funds are general in nature, and are intended to increase government’s future revenue in general to offset government’s unfunded superannuation liability in the future. Some are even used to fund infrastructural projects, in hopes that these projects will contribute to more government revenue in

811

 The Economics of Long-Term Care

the future, enabling government to spend more on social welfare services then (Tsang, 2014). They can also be earmarked for specific purposes, for example for health and long term care. These earmarked funds can provide more reliable funding to the intended services, as these services do not need to compete with other forms of public service. The competition from all forms of public service is expected to be acute as the population ages.

Prices and Quantity Price times quantity of long term care services represent the total expenditure on long term care. Given the total amount is determined by the factors in the left hand side of the equation, high price charged by providers would limit the quantity of services to be available, resulting in long waiting list for the needed services. The price charged is determined largely by the wage level of different types of care workers, and the cost for the use of the space for the facilities. Skilled health care professionals, such as doctors, nurses, physiotherapists, occupational therapists, are generally well paid and will be reflected in the price charged for the care. A well planned mix of health care professionals leading teams of lesstrained carers can reduce costs. In expensive cities, if private facilities are required to pay market price for the use of space, and the charges for their service would bound to be prohibitively high. NGOs for long term care are often provided space at nil or greatly reduced rental by government in order to keep their price level low.

PAYING SYSTEMS FOR LONG TERM CARE Paying systems for long term care providers vary. It includes block grants, per diem rates, fee-for-service, case mix payments, and pay for outcome (Jacobs & Rapoport, 2014). Liang (1991) advocates a system that gives financial power to the elderly to safeguard their independence and a system that could promote supply-side innovations and diversity of services.

Block Grants This is the most traditional payment system, whereby government or some funding body provides a block grant to a government unit or to an NGO in the form of subvention for the delivery of long term care services. This is common for tax-based systems. Some form of contractual agreement is made between the funder and the provider. This type of funding does not encourage the provider to be consumer oriented, as money does not follow patients under this system. There is a need to monitor quality closely. There is also little financial incentives for the provider under this type of funding to be efficient.

Fee-for-Service This is less common for long term care providers, but can be found for certain selected services provided by some commercial providers as well as by NGOs providing services on a self-financing basis. Supply side moral hazards exist under this mode of payment – there is a tendency for providers to provide more than what is necessary. Providers paid by such system are generally more eager to please consumers than those funded by the block grant system.

812

 The Economics of Long-Term Care

Per Diem Payment Providers are paid based on the average daily or sessional cost for providing care. It can be based on a flat per diem rate or facility specific per diem rates (e.g. one rate for skilled nursing care and a different rate for intermediate care). This is common for insurance based systems. The advantage of this payment is that institutions have incentives to minimize costs, while the disadvantages include providers cherry picking healthier patients and the tendency for them to compromise on quality.

Case Mix Payment Under this payment systems, patients are charged based on groups associated with the patients’ ADL scores and the associated services required such as the degree of cognition impairment, rehabilitation requirements etc. (Schlenker, 1986). If condition of the patient changes, the payment rate will change accordingly. A commonly used case mix payment system is the Resource Utilisation Groups (RUG) (Fries & Conney, 1985), which has subsequently been updated as RUG II (Micheletti & Shlala, 1986) and RUG III (Fries et al, 1994). The advantage of this type of payment system is that the payment to providers reflects closely accurate cost for the services without the incentives to deliver unnecessary services. The disadvantage is that the system provides no incentives to help improve the condition of the patient, as payment will decrease when the patient dependency is reduced.

Pay for Outcome This payment system attempts to address the perverse incentives described above. Institution will receive a higher payment if the outcome is achieved – i.e. when the patient’s dependency improves. As the implementation is more complicated and requires close monitoring of the patient’s condition and the quality of care provided, adoption of such payment system is still uncommon.

MAJOR FINANCING MODELS The section examines existing models of long term care financing of various countries and the associated advantages and disadvantages of each model. There are different ways to categories major models of long term care financing systems. OECD has grouped different countries’ long term care systems into three main clusters: (1) universal coverage within a single programme; (2) means-tested safety-net schemes; and (3) mixed systems (OECD, 2011b). This chapter categories long term care systems according to their main source of financing. Accordingly, long term care financing systems are classified as either: (a) mainly tax-based; (b) mainly insurance based; or (3) a combination of both.

Tax-Based Systems For tax-based systems (e.g. UK, Nordic countries, Australia, New Zealand, Hong Kong), LTC services are heavily subsidized by different levels of government from general taxation without the creation of a separate long term care fund. Copayment for services is common. Services can be provided directly

813

 The Economics of Long-Term Care

by government units or through NGOs. Long waiting time for services is quite common. Some countries also provide cash payment or vouchers for selected services in lieu of direct service provision. Universal coverage is common, although some countries limit the benefits to the elderly age group and/ or persons below certain income (means-tested). For example, Nordic countries -- Denmark, Finland, Norway and Sweden -- generally provide universal coverage, while the UK requires mean-testing for personal care, but not for services for the severely disabled. Hong Kong’s publicly funded LTC services are nonmeans-tested, but waiting time to access them could be long, and many families have no choice but to purchase services in the self-financing sector. The advantage of such non-earmarked approach to funding is the simplicity and the relatively low administration costs required. The major disadvantage of such system is the lack of reliable funding, as there will always be fierce competition for funding from general taxation, especially for countries with a rapidly ageing population, in which tax revenue is likely to shrink because of the shrinking working population. Underfunding is quite common under such mode of financing (OECD 2011b, Chu & Chi 2006, Social Welfare Department 2013, South China Morning Post 2014, Yuen 2014).

Insurance-Based Systems Long term care services under such systems could be funded by a standalone compulsory, universal coverage for the elderly, long term care insurance scheme (e.g. Germany), or a compulsory scheme with universal access as part of the social insurance or mandatory health insurance scheme (e.g. Belgium, Netherlands), or a mean-tested scheme as part of the health insurance scheme (Medicaid in USA) (OECD 2011b). There are also voluntary private long term care insurance plans, but no countries adopt them as the dominant funding source for long term care services. They tend to be supplementary plans. Even for the USA, where private health insurance is the dominant form of financing for health care, only 4 percent of total long termcare costs are paid for by private insurance (Brown and Finkelstein 2008). The comprehensiveness of coverage (i.e. the basket of services covered) and the level of copayment vary quite significantly among different types of schemes as well as within the same type. Standalone programmes tend to be more comprehensive in terms of coverage and lower in terms of copayment, as they create a sense of entitlement for the enrollees. The disadvantage of the separation of health care and long term care funding is the possible creation of barriers to continuity of care as well as tendencies to shift costs from one sector to another.

Mixed Systems While most countries tend to have a mix of funding sources for the financing of LTC services, countries with “mixed systems” refer to those with tax and LTC Insurance both playing a very significant role in terms of the share of financing. For example, in Japan, tax and mandatory long term care insurance each constitute around 45 percent of the total long term care payments. In Korea, the share is 37 percent from tax and 52 Percent from mandatory long term care insurance (OECD, 2011; Ichien, 2000; Kwon, 2009). In Singapore, all citizens over the age of 40, are automatically enrolled, with opt-out option, on Eldershield, a long term care insurance scheme. The Singaporean Government also uses tax revenue to subsidized middle to low income households (covering two-thirds of all households) to offset part of the copayment expenses for long term care services (Chee & Phua, 2016). In addition, Eldercare Fund

814

 The Economics of Long-Term Care

and Community Silver Trust Fund are funds set up by the Singaporean Government using tax money to provide grants to NGOs. In short, mixed systems permit long term care insurance premium level to remain low, as tax revenues are used to subsidize the long term care insurance schemes. Tax revenue can also be used to provide direct subsidies to patients for systems with high copayment. Finally, tax revenue is also used to provide capital grants to NGOs to facilitate supply.

CONCEPTUAL FRAMEWORK IN REFORMING LONG TERM CARE SYSTEMS The above sections indicate that arrangements for the financing and delivery of long term care services vary greatly from country to country. Economists are interested in finding a resource allocation pattern which is optimum. Who should provide the service? Who should pay for the service? What pattern of financing and care is cheaper to operate? What pattern produces better quality? What pattern is more equitable? What pattern promotes greater efficiency? The above questions suggest that there are two dimensions involved: financing and provision. Each of the dimension of a long term care service can be described by a public/private mix continuum as shown in Box 1. The entire long term care system is combination of the different types of services – (1) residential care, (2) day care and (3) home care -- each with its own pattern of public/private financing and delivery. The position on the continuum could be different for three different of types of long term care services. For example, for the financing dimension, residential care are heavily subsidized publicly in some countries, while most community based services have to be paid for privately. In other countries, government subsidizes community based services in an attempt to incentives community based care, and require higher co-payment on the part of the patient for residential services. As for the provision dimension, variations also exit as to whether the service is provided by government, NGOs, or private for profit organizations. While the continuum is a theoretical one, the type of system that exists in most countries tend to lie somewhere in between the two extremes. Incorporating the financing and delivery dimensions, long term care systems can best be described by the following Figure for a given type of service. Square 1 represents a system that is predominantly private in both financing and delivery: e.g. a patient paying for a services out of pocket or through private insurance in a private nursing home; Square 2 represents a system that is paid for publicly but delivered by private providers: e.g. a public voucher system in which a patient can choose a private provider and pay for the service using a government voucher; Box 1. ­ --------------------------------------------------------------------------------------------------100% Private 100% Public

815

 The Economics of Long-Term Care

Figure 1. ­

Square 3 represents a system that is predominantly public in both financing and delivery: e.g. a patient paying very little for services in a publicly owned and financed institution; Square 4 represents a user pay system in which government provides most of the care, but the patient is required to pay for the full cost or a significant percentage of the actual cost. Reforming the long term care system would involve examining the impact and desirability of moving from one position to another in the graph – e.g. should government provide more or less subsidies to a particular type of long term care; should more or less private organizations be involved in the provision. In general, greater public financing promotes greater equity, while more private financing and delivery can lead to a faster supply of services. Directions of reform should be based on the characteristics of the system as well as the values of its residents.

CONCLUSION Building an equitable long term care system that delivers high quality care and is sustainable is the goal of most government. However, in view of the speed of population aging and the magnitude of the problem, status quo or even incremental changes to the existing systems are not likely to be adequate to achieve that goal. A more revolutionary response to population ageing is needed to transform systems and policies that are fundamentally misaligned with population trends. Achieving such alignment will require a clear understanding of the above-mentioned economics associated with older age and a focused conceptualization of what needs to be done to cope with this serious situation which is best suited to the historical and cultural context of the country/region. Presently, the workforce in most countries is too acute-centric, resources are directed disproportionately to inpatient care, high out-of-pocket expenditure for the consumer is common (the majority of whom do not have regular income), the financing system seldom empowers the elderly to purchase the kind of service that he/she desires, and most of these systems do not appear to be sustainable in light of the rapidly shrinking working population.

816

 The Economics of Long-Term Care

The transformation of the financing and delivery systems of such magnitude is not likely to be able to evolve naturally on their own. Government stewardship is crucial and necessary. More evidence based inquiries into the forces of supply and demand, and into the incentive systems associated with financing and payment are required to underpin policy reform initiatives that are urgently needed.

REFERENCES Atun, R. (2004). What are the advantages and disadvantages of restructuring a health care system to be more focused on primary care services? Copenhagen: WHO Regional Office for Europe. Retrieved from http://www.euro.who.int/document/e82997.pdf Australian Institute of Health and Welfare. (2015). Use of aged care services before death. Data linkage series no. 19. Cat. no. CSI 21. Canberra: AIHW. Berg, K., Wood-Dauphinee, S., Williams, J. I., & Makki, B. E. (1992). Measuring balance in the elderly: Validation of an instrument. Canadian Journal of Public Health, 83, S7–S11. PMID:1468055 Brown, J., & Finkelstein, A. (2007). Why is the market for long-term care insurance so small? Journal of Public Economics, 91(10), 1967–1991. doi:10.1016/j.jpubeco.2007.02.010 Brown, J., & Finkelstein, A. (2008). The interaction of public and private insurance: Medicaid and longterm care insurance market. The American Economic Review, 98(3), 1083–1102. doi:10.1257/aer.98.3.1083 Chappell, N. L., Dlitt, B. H., Hollander, M. J., Miller, J. A., & McWilliam, C. (2004). Comparative Costs of Home Care and Residential Care. The Gerontologist, 44(3), 389–400. doi:10.1093/geront/44.3.389 PMID:15197293 Cheung, K. K. W., Au, K., Lam, W. W. S., & Jones, A. Y. M. (2008). Effects of a structured exercise programme on functional balance in visually impaired elderly living in a residential setting. Hong Kong Physiotherapy Journal, 26(1), 45–28. doi:10.1016/S1013-7025(09)70007-7 Chin, C. W. W., & Phua, K. (2016). Long Term Care Policy: Singapores Experience. Journal of Aging & Social Policy, 28(2), 113–129. doi:10.1080/08959420.2016.1145534 PMID:26808468 Chin, C. W. W., & Phua, K. H. (2016). Long-term care policy: Sinagapores Experience. Journal of Aging & Social Policy, 28(2), 113–129. doi:10.1080/08959420.2016.1145534 PMID:26808468 Chu, L. W., & Chi, I. (2006). Long-Term Care and Hospital Care for the Elderly. In G. M. Leung & J. Bacon-shone (Eds.), Hong Kong’s Health System (pp. 223–252). Hong Kong: Hong Kong University Press. Chui, W. E., Chan, K., Chong, M. A., Ko, S. L., ... Ng, Y. S. (2009). Elderly Commission’s Study on Residential Care Services for the Elderly: Final Report. The University of Hong Kong. Chung, R. Y., Tin, K. Y. K., Cowling, B. J., Chan, K. P., Chan, W. M., Lo, S. V., & Leung, G. M. (2009). Long-term care cost drivers and expenditure projection to 2036 in Hong Kong. BMC Health Services Research, 9(1), 172. doi:10.1186/1472-6963-9-172 PMID:19775476

817

 The Economics of Long-Term Care

Collin, C., Wade, D. T., Davies, S., & Horne, V. (1988). The Barthel ADL Index: A Reliability Study. International Disability Studies, 10(2), 61–63. doi:10.3109/09638288809164103 PMID:3403500 Colombo F. and J Mercier (2011). Balancing fair protection and financial sustainability in long-term care. Eurohealth, 17(2–3), 3-6. Coulson, I., Minichiello, V., Kao, R. S., Lin, F., & Wan, C. C. (2000). Developing collaborative gerontology programs offshore: A case study. Educational Gerontology, 26, 387–400. doi:10.1080/036012700407866 Feldstein, P. J. (1993). Health Care Economics. Albany, NY: Delmar Publishers. Folstein, M. F., Fostein, S. E., & McHugh, P. R. (1975). Mini-mental state: A practical method for grading the cognitive state of patients for the clinician. Journal of Psychiatric Research, 12(3), 189–198. doi:10.1016/0022-3956(75)90026-6 PMID:1202204 Fries, B. E., & Cooney, L. M. (1985). Validation and use of resource utilization groups as a case-mix measure for long-term care. Medical Care, 23(2), 123–132. doi:10.1097/00005650-198502000-00003 PMID:3919223 Fries, B. E., Schneider, D. P., Foley, W. J., Gavazzi, M., Burke, R., & Cornelius, E. (1994). Redefining a case mix measure for nursing homes: Resouce utilization groups (RUG-III). Medical Care, 32(7), 668–685. doi:10.1097/00005650-199407000-00002 PMID:8028403 Harvard Team. (1999). Improving Hong Kong Health Care System: Why and for Whom? Hong Kong: HKSAR Government Printer. Ichien, M. (2000). Introduction of Long-term Care Insurance in Japan. International Review of Public Administration, 5(2), 23–36. doi:10.1080/12294659.2000.10804953 Kingsley, D. E. (2015). Aging and health care costs: Narrative versus reality. Poverty & Public Policy, 7(1), 3–21. doi:10.1002/pop4.89 Kua, E. H., & Tan, S. L. (1997). Stress of caregivers of dementia patients in the Sinagore Chinese family. International Journal of Geriatric Psychiatry, 12(4), 466–469. doi:10.1002/(SICI)10991166(199704)12:43.0.CO;2-U PMID:9178051 Kwon, S. (2009). Introduction of Long-Term Care Insurance in Korea. Paper presented at the Asian Social Protection in Comparative Perspective Conference, Singapore. Lawton, M., & Brody, E. (1969). Assessment of older people: Self-maintaining and instrumental activities of daily living. The Gerontologist, 9(3 Part 1), 179–186. doi:10.1093/geront/9.3_Part_1.179 PMID:5349366 Liang, W. (1991). Empowering The Elderly: Direct Consumer Funding of Care Services. Choice in Welfare Series No. 6. London: IEA Health & Welfare Unit. Lou, Kwan, & Chan. (2011). A Study on the Effectiveness of Community Care Services in Hong Kong. The University of Hong Kong. Mahoney, F. I., & Barthel, D. W. (1965). Functional evaluation: The barthel index. Maryland State Medical Journal, 14, 61–65. PMID:14258950

818

 The Economics of Long-Term Care

Metha, K. K. (2005). A critical review of Singapore’s policies aimed at supporting families caring for older members. Journal of Aging & Social Policy, 18, 43–57. PMID:17135094 Micheletti, J., & Shlala, T. J. (1986). RUGsII: Implications for management and quality in long-term care. Quality Review Bulletin, 12(7), 236–242. doi:10.1016/S0097-5990(16)30049-5 PMID:3092161 Ministry of Health. (2000). Eldercare Fund. Ministry of Health. Retrieved from: https://www.moh.gov.sg/ content/moh_web/home/pressRoom/pressRoomItemRelease/2000/establishment_of_eldercare_fund.html Ministry of Health. (2012). Community Silver Trust. Ministry of Health. Retrieved from: https://www. moh.gov.sg/content/moh_web/home/pressRoom/Parliamentary_QA/2012/community_silvertrust.html Morse, J. M., Morse, B. M., & Tylko, S. (1986). Development of a scale to identify the fall-prone patient. Canadian Journal on Aging, 8, 66–77. Norton, D., McLaren, R., & Exton-smith, A. N. (1979). An investigation of Geriatric problems in hospital (3rd ed.). London: Churchill Livingstone. OECD. (2001a). Private long term care insurance: A niche or a “Big Tent”? OECD. OECD. (2011b). Public Long-term Care Financing Arrangements in OECD Countries in Help Wanted. Providing and Paying for Long Term Care. OECD. Oliver, D., Foot, C., & Humphries, R. (2014). Making our health and care systems fit for an ageing population. London: The King’s Fund. Rolden, H. J. A., van Bodegom, D., & Westendorp, R. G. J. (2014). RGJ. Variation in the costs of dying and the role of different health services, socio-demographic characteristics, and preceding health care expenses. Social Science & Medicine, 120, 110–117. doi:10.1016/j.socscimed.2014.09.020 PMID:25238558 Samuelson, P. A. (1976). Economics. Tokyo: McGraw Hill. Savings Working Group Final Report to the Minister of Finance. (2011). Saving New Zealand: Reducing Vulnerabilities and Barriers to Growth and Prosperity. Retrieved from http://purl.oclc.org/nzt/r-1348 Schlenker, R. E. (1986). Case mix reimbursement for nursing homes. Journal of Health Politics, Policy and Law, 11(3), 445–461. doi:10.1215/03616878-11-3-445 PMID:3098827 Social Welfare Department. (2013). Legislative Council Paper CB(2)673/12-13(01) Long-term Care Policy for the Elderly and Persons with Disabilities. Paper presented to the Joint Subcommittee on Long Term Care Policy. South China Morning Post. (2014). Hong Kong faces challenge ensuring the elderly feel right at home. Retrieved from http://www.scmp.com/news/hong-kong/article/1433787/hong-kong-faces-challengeensuring-elderly-feel-right-home Spector, W. D., & Fleishman, J. A. (2001). The Characteristics of Long-Term Care Users. U.S. Department of Health and Human Services, Agency for Healthcare Research and Quality Research Report. Stuck, A.E., Egger, M., Hammer, A., Minder, C.E., & Beck, J.C. (2002). Home visits to prevent nursing home admission and functional decline in elderly people: systematic review and meta-regression analysis. JAMA, 287(8), 1022–8. 819

 The Economics of Long-Term Care

Tong, A. Y., & Man, D. W. (2002). The validation of the Hong Kong Chinese version of Lawton instrumental activities of daily living scale for institutionalized elderly persons. The Occupational Therapy Journal of Research, 22, 132–142. Tsang, J. C. (2014). The 2014-15 Budget. Speech by the Financial Secretary, the Hon John C Tsang moving the Second Reading of the Appropriation Bill 2014, 26 February 2014, Hong Kong. United Nations Population Division. (2001). New York: World Population Ageing. Vos, T., Goss, J., Begg, S., & Mann, N. (2007). Projection of health care expenditure by disease: a case study from Australia. New York: United Nations. WHO. (2015). World Report on Aging and Health. Retrieved from: http://www.who.int/ageing/events/ world-report-2015-launch/en/ Woo, J. (2007). Development of elderly care services in Hong Kong: Challenges and creative solutions. Clinical Medicine, 6(6), 548–550. doi:10.7861/clinmedicine.7-6-548 PMID:18193700 Yeo, B., & Huang, S. (2009). Foreign domestic workers and home-based care for elders in Singapore. Journal of Aging & Social Policy, 22(1), 69–88. doi:10.1080/08959420903385635 PMID:20390713 Yesavage, J. A., Brink, T. L., Rose, T. L., Lum, O., Huang, V., Adey, M., & Leirer, V. O. (1983). Development and validation of a geriatric depression screening scale: A preliminary report. Journal of Psychiatric Research, 17(1), 37–49. doi:10.1016/0022-3956(82)90033-4 PMID:7183759 Yuen, P. P. (1992). The Privatization of Hospital Services: An Empirical Study of the Determinants of the Public/Private Mix. Hong Kong Public Administration, 1(1), 24-64. Yuen, P. P. (2014). Financing Health Care and Long-term Care in a Rapidly Ageing Context: Assessing Hong Kong’s Readiness. Public Policy and Administration, 17(1), 56–64.

This research was previously published in Sustainable Health and Long-Term Care Solutions for an Aging Population edited by Ben Fong, Artie Ng, and Peter Yuen, pages 1-18, copyright year 2018 by Medical Information Science Reference (an imprint of IGI Global).

820

821

Chapter 41

Long-Term Care Spending Relevant to U.S. Medicaid Expansion:

Medicaid Long-Term Care Spending Mary Schmeida Kent State University, USA Ramona Sue McNeal University of Northern Iowa, USA

ABSTRACT The U.S. population is living longer, placing a demand on long-term care services. In the U.S., Medicaid is the primary player in funding costly long-term care for the aged poor. As a major health reform law, the 2010 Patient Protection and Affordable Care Act, Public Law 111-148, gives financial incentive for states to expand Medicaid, transitioning long-term care services from facilities toward community care. Facing other funding obligations and recent recessions, not all states expanded their Medicaid long-term care program using the financial incentives. Some states continue to spend more dollars on traditional nursing facility care despite legislation. This chapter explores why some states spend more revenue on nursing facility long-term care despite enhanced federal funding to reform, while others are spending more on home and community-based services. Regression analysis and 50 state-level data is used.

INTRODUCTION Longevity has increased in high-income countries (World Health Organization, 2014). In the U.S., those 65 years and older are living longer, placing a demand on long-term care services. Nearly 82.3 million seniors are expected in the U.S. by 2040, over twice that in 2000 (U.S. Dept. of Health and Human Services, 2014, p. 3). “With the percentage of our population who are elderly or disabled increasing faster than that of the younger groups, the need for long-term care is expected to increase” (Centers for Medicare DOI: 10.4018/978-1-5225-7122-3.ch041

Copyright © 2019, IGI Global. Copying or distributing in print or electronic forms without written permission of IGI Global is prohibited.

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

and Medicaid Services [CMS], November 16, 2015, p. 31). Medicaid long-term care service(s) are an option for those American seniors facing poverty, yet, need substantive care (Schmeida & McNeal, 2015). The history of Medicaid funding for community-based long-term healthcare is over 30 years. In 2010, U.S. legislation in support of Medicaid expanded to fit the needs of many poor population groups, including the fast growing aged poor with long-term care needs. Reforming healthcare, the 2010 Patient Protection and Affordable Care Act (ACA) offers financial incentive for states to increase their Medicaid enrollment including long-term care (Public Law 111–148, 2010). It builds upon the Deficit Reduction Act of 2005 (Public Law 109-171, 2005) to “rebalance state Medicaid long-term care spending” from nursing facility care to home and community-based services, allowing the recipient to remain in a beneficial community setting, less costly to government (Mathematica, 2014, p. 2; Public Law 111-148, 2005; Schmeida & McNeal, 2015). The idea of home and community-based long-term care is growing, made “doable” as financial support improves, political ideological values promote, and caregivers make it a realization (Schmeida & McNeal, 2015). In Fiscal Year 2015, Medicaid enrollment increased by 13.8% (on average) across the 50 states, and total Medicaid spending increased 13.9% on average (Kaiser Family Foundation [KFF], October 2015, p. 1). How states in the U.S. attempt to meet their many financial obligations while addressing a demand for long-term care is becoming a delicate balancing act. There are many issues state leaders consider when providing long-term care including how to best maximize Medicaid dollars. This chapter explores why some states continue to spend more revenue on traditional nursing facility care despite federal incentives to reform, while other states are spending more on home and community-based services. Specifically, what factors (state economic [supply and demand], political, and need/ demand) explain the differences in Medicaid long-term care spending across the 50 states? This chapter answers this question using multivariate regression analysis and 50 state-level data.

POLICY BACKGROUND A timeline of the 1935 Social Security Act (SSA) and its amendments reveals how U.S. social policies have evolved into the modern day reform effort. Federal benefits for the aged did not become law until the Roosevelt Administration signing of the 1935 Social Security Act (Public Law 74-271, 1935). This Act (SSA) offered federal old age grants, helping states with provisions for “aged persons, blind persons, dependent and crippled children, maternal and child welfare, public health, and the administration of their unemployment compensation laws” and other purposes. It created the “Old-Age Reserve” account, now known as Social Security under its Title II. This was a venue for today’s private nursing home industry by prohibiting social security payout to recipients residing in substandard public poor homes (P.L. 74271, p. 620-622; KFF, August 2015, p. 1). Since inception, the SSA of 1935 has grown in scope. Once a worker’s “retirement program” is now a family security program (CQ, 2015); nursing homes now receive the medical payments for care not beneficiaries; and Medicare and Medicaid programs were added in 1965 (Public Law 89-97). Unlike Medicare that covers medical care for the aged, Medicaid is the U.S. social insurance program for the poor. As a redistributive program, it manipulates the allocation of property rights, wealth, and other value among social classes (Ripley & Franklin, 1980). Medicaid is a federal-state means tested insurance program (CMS, 2014), with the federal government giving states financial assistance (cost sharing) as an incentive to subsidize care and service its residents (Public Law 111-148, 2005). As an open-ended matching program, states must provide services for mandatory

822

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

“categorically needy” populations, such as the aged, blind, and disabled to receive any federal matching funds (CMS, November 16, 2015, p. 24). The Social Security Amendments of 1965 biased Medicaid toward institutional nursing home care (Public Law 89-97, 1965; KFF, December 2015), but this has changed. In 1981, a SSA amendment (Section 1915c) allows states to offer home and community-based services (HCBS) as an alternative to traditional nursing home care (KFF, August 2015), with the state of Oregon first to use HCBS waivers (Kane, 2012). In 1999, the Supreme Court in Olmstead v. L.C. ruled it a violation of the Americans with Disability Act of 1990 (requiring the disabled be provided with appropriate accommodations in housing, employment and public service) not to open up HCBS to the disabled (Public Law 101-336; Kane, 2012). With time more changes are made to policies for the aged. Under the George W. Bush Administration, the Deficit Reduction Act of 2005 gave states federal monies to further expand HCBS (Public Law 109-171, 2005). To date, states have the option to offer HCBS to residents, while the traditional nursing home from the original 1965 Act remains as a mandatory back-up. In 2010, the Patient Protection and Affordable Care Act (ACA), considered key reform, gave states even more Medicaid long-term care options (Public Law 111–148, 2010; KFF, August 2015). Provisions include expanding eligibility; improving nursing home transparency; more expansion of HCBS long-term care; de-institutionalizing the disabled; and funding aging and disability centers (Public Law 111–148, 2010; National Conference of State Legislatures, 2011; KFF, December 2015, p. 6). Most of ACA’s long-term care provisions have money inducement. In ACA’s Balancing Incentive Payments Program, for example, “states may receive additional Medicaid matching funds when they meet certain requirements for expanding the percentage of long-term care spending for home- and community-based services” (National Conference of State Legislatures, November, 2011, p. 1). Politically, response to ACA’s Medicaid expansion has varied across federal and state leadership. In January 2016, the U.S. Congress passed legislation to phase it out, but was vetoed by former President Barack Obama. Change may yet occur since recent U.S. elections have brought in a new presidential administration (Donald Trump) differing in party and ideology. Although Medicaid is redistributive, change may occur since the characteristics of ACA are regulatory. Regulatory policy brings conflict within the policy community, and usually transferred to a higher level (Ripley and Franklin, 1980) for resolution. Medicaid long-term care stakeholders include recipients, industry, and government. The U.S. Department of Health and Human Services and its Centers for Medicare and Medicaid Services are major players in program implementation (CMS, 2015). Interest groups, e.g. the Americans with disabilities have played a role in moving long-term care dollars from traditional nursing homes to home and community-based settings, expanding HCBS waivers for the aged (Kane, 2012).

MEDICAID LONG-TERM CARE FINANCING As a federal-state matching program with shared responsibility, the federal government guarantees one dollar for every state dollar spent on Medicaid, with enhanced matching rates for particular services (KFF, May, 2015). The state’s share of Medicaid spending largely depends on tax revenue. Personal income, corporate income, and largely property taxes are big sources, with local sales tax the second largest in the “total” local tax revenue (Rockefeller Institute of Government, March, 2016). However, not all states are alike. Alaska e.g. differs in having neither personal income tax nor sales tax, mostly funding its state budget from oil taxes and royalties (KFF, October 15, 2015a).

823

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

State Fiscal Stress The state share of the federal-state matching formula has been challenged by recession budget deficits (2001 and 2007) and other state obligations external to Medicaid (Pew, December 10, 2015; United States Government Accountability Office [GAO], 2011). With greater enrollment and lesser state funds, funding was a stretch for most, and state policy action was taken to stimulate state revenue. California e.g. implemented “a number” of policies to decrease spending and increase revenue when budget shortfall was multi-billion (KFF, October 15, 2015b). Also, the U.S. Congress enacted the American Recovery and Reinvestment Act of 2009 giving states “general fiscal relief,” temporarily increasing the federal share of the matching rate or Federal Medical Assistance Percentage (Public Law 111-5, 2009; GAO, 2011, p. 1). To prevent deficit cut-backs on government programs, the GAO (a Congressional arm) recommended a prototype formula for temporary increases in the FMAP providing an automatic, timely, and targeted state assistance, using the U.S. labor market as trigger for the increases (GAO, July, 2015). State recession recovery has not been uniform. The 2015 total end-of-year budget balance (in dollars and a share of expenditures) “was lower than at the pre-recession peak” across states (Pew, January 5, 2016, p. 1), with a few still facing a budget deficit. Alaska for example, has faced a deficit since 2013 (KFF, October 15, 2015a), while others---Arizona, California, Minnesota, and Virginia have a budget surplus (Pew, January 27, 2016). Many states are cautious to commit spending their recession recovery on pricey projects, such as Medicaid, as “recent volatility and losses in the stock market foreshadow less income tax revenue. And the trend in sales tax receipts is weakening, as consumers turn to untaxed Internet sales and cautious buying habits” (Pew, January 27, 2016, p. 2). States have forecasted a slow tax revenue growth for 2016 and 2017 (Rockefeller Institute of Government, March 2016, p.18). The GAO projects Medicaid spending to increase about 60% by fiscal year 2023 (GAO, July, 2015).

Long-Term Care Expenditure Government healthcare spending is largely driven by ACA’s expansion of Medicaid (CMS, November 16, 2015, p. 6). In fiscal year 2015, 29 states expanded and “spending growth in expansion states far exceeded growth in non-expansion states” (p. 1). Hikes in provider costs, health services including drug costs explained the total spending increases, on average 13.9% (KFF, October, 2015, p. 1). Fully funded by the federal government, ACA temporarily raised physician reimbursement for particular Medicaid fees and primary care services, included are internists and family physicians (Urban Institute, 2014, p. 1). This was done as an inducement to physicians to cover projected Medicaid enrollee increases. Some provider rate increases (Alaska), however, were done prior to ACA (Kaiser Family Foundation, October 15, 2015a). Long-term care expenditures are led by nursing home facilities or “institutions.” The CMS (2014) reports, 2013 long-term care expenditures led all Medicaid costs with nursing facility expenditures at $38.3 billion, managed care at $10.7 billion, home and community-based waivers at $5 billion, and inpatient hospital at $3.4 billion (pp. 45-46). As a percent of total Medicaid long-term care spending, between 2002 (32%) and 2013 (46%) there was a 14% increase, largely from community-based services such as home health, and states waiving the Title XIX federal nursing home requirement so as to use community-based services (KFF, December, 2015, p. 5, 8). Noted, home and-community-based-service recipients spend less on long-term care than those institutionalized (MACPAC, June, 2014).

824

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

While politicians often emphasize the financial savings on moving away from the traditional nursing facility toward home and community-based services, other actors frame the debate differently. Citizens of the 1970s demanded an alternative to nursing facilities that were poor in quality, while the disabled in the 1990s argued discrimination and segregation for limiting them to a facility setting. Today, states have choices in how they distribute Medicaid spending on long-term care (Public Law 111–148, 2010). While many states are following the federal lead allocating more money on home and community-based services, other states continue to spend monies primarily on nursing facilities.

State Revenue Opportunity Expanding Medicaid long-term care services can be a money opportunity for states, not necessarily a cost burden. Under ACA (Public Law 111–148), Medicaid expansion can generate state revenue. States are responding to Medicaid’s matching cost obligation with alternative sources of financing. According to the GAO, there has been an increase in state use of healthcare provider tax (such as nursing homes) and local governments to supplement state general funds in covering costs. In state fiscal year 2012, 26% or over $46 billion of “total nonfederal share of Medicaid payments” was generated from health provider taxes ($18.8 billion) and local government funds ($18.1 billion); and can result in an increase of federal matching funds (December, 2015, p. 8, 10). State Medicaid spending can have a “multiplier effect” on state economy, bringing payment to health providers and indirectly effecting businesses and industries (KFF, May, 2015, p. 9), such as the medical goods industry. In effect, Medicaid can be a source of federal revenue to states (KFF, May, 2015) adopting expansion, but also a growing expenditure as the guaranteed 100% federal matching for adopting states levels off at 90% by 2020, leaving adopters responsible for the 10%. As an inducement to expand long-term care, ACA gives several enhanced funding options for long-term care home and community-based services. States can choose among the options to increase their funding (KFF, December, 2015, p. 6).

POLICY IMPLEMENTATION: THE COMMUNICATIONS MODEL In exploring variation to state compliance with the Obama Administration’s health reform policy (ACA), this study turns to the Goggin, Bowman, Lester, and O’Toole (1990) Communications Model designed to frame intergovernmental policy, such as the U.S. Medicaid program. The goal of this model is to depict implementation over time and determine why there is variation in how states implement federal laws. Goggin et al. (1990) argue that communication is center in policy implementation. Policy content and message, in addition to the level of communication federal agencies have with state and local agencies, is likely to affect the success or failure of implementation. If state and local policy implementers regard the message and content as credible, implementation of the law is more likely to mirror its original intent. The dependent variable under this framework is the extent to which the state has carried out federal policy. Depending on the state, implementation may be categorized as delay, defiance, compliance, or strategic delay (1990). The main independent variables under the Communication Model are federallevel and state-level inducements and constraints. The federal government can compel the states to act through inducements such as offering states financial incentive to expand Medicaid enrollment and long-term care services, constraints such as mandating nursing facility care upon all states, sanctions or a combination of both. In the case of long-term care, the federal government is compelling states to

825

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

“rebalance state Medicaid long-term care spending” from nursing home institutional care to home and community-based services (Mathematica, 2014). The Obama Administration relied on inducements to promote state compliance to expand Medicaid in the form of an enhanced federal funding matching rate for new enrollees of select populations. Specifically, a 100% guaranteed federal match rate inducement for states adopting expansion from 2014-2016, leveling off at 90% by 2020 (leaving adopting states responsible for 10%), but no enhanced funding for non-expansion states (KFF, May, 2015). State-level inducements and constraints often take the form of pressure from state and local groups. Depending on how the policy impacts stakeholders at the state and local level, they may either help or hinder its implementation. The intervening variables are state organizational and ecological capacities, or resources which allow state officials to ignore messages from other political actors. State organizational capacity refers to items such as a state’s administrative personnel and financial commitment to a program. State ecological capacity refers to factors such as public opinion and the economic well-being of the state (Goggin et al, 1990). Other have applied the Communication Model but across different policy domains, such as environmental, telecommunication, and education policy areas. Using Goggin et al (1990), Cline (2003) analyzed the State Environmental Protection Agency Superfund program for environmental cleanup from 1987 to 1994 at the state-level using a pooled cross-sectional time-series analysis with an event-count model. This study found organizational capacity, and state-local level inducements and constraints can influence EPA Superfund program implementation. Using the Communication Model, McNeal (2012) explored state response to federal funding initiatives for improving high-speed broadband infrastructure and local government ownership of broadband facilities. Using multivariate regression analysis and 50 state data, McNeal found state-local inducements and constraints (good government interest group strength) and ecological capacity (Republican Party control of state government) mattered in implementation. Dotterweich-Bryan and McNeal (2004) studied state response to the No Child Left Behind Act of 2002. Using the Communication Model, 50 state data, and multivariate methods they found the greatest impact was state political ecological capacity (including state minority diversity, legislative professionalism and professional networks). Contrary to other studies, state-local inducements and constraints (education interest groups) did not have a significant impact on implementing the Act. Applying the Communication Model, we explore why some states continue to spend more revenue on traditional nursing facility care despite federal financial incentives to reform, whereas other states are expanding their home and community-based services. We explore this question using empirical analysis.

EMPIRICAL MODEL: DATA AND MEASUREMENT Data This chapter uses secondary data analysis to explore why some states spend more revenue on nursing facility long-term care despite enhanced federal funding to reform, while others are spending more on home and community-based services. The dataset for this study was compiled using a number of sources including state and government websites as well as nonprofit organizations, among other groups. Among these sources are the U.S. Census Bureau, the U.S. Bureau of Commerce, the Kaiser Family Foundation and the Pew Charitable Trust. Most of the study variables are common to implementation research, while a few are unique to this policy area.

826

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

Determinants of Spending on Long-Term Healthcare The exploration of why certain states favor nursing facilities over home and community-based services begins with an examination of state factors that influence the amount of money each state dedicates to each alternative healthcare delivery strategy. The literature on policy adoption suggests there are factors that explain the differences in state spending. Early research found socio-economic factors including state wealth are important to policy adoption (Gray, 1973; Hwang & Gray, 1991), while other studies point to politics (Mooney & Lee, 1995). In addition, the literature shows that greater demand or need for a policy increases the chance for adoption (Meier, 1994; Mooney & Lee; 1995). Although each of these factors matter in policy adoption, their relative importance depends on the policy area being examined. Medicaid, like other forms of public assistance, is a redistributive policy. Since these policies provide benefits to one group at the expense of another, they are known for policy conflict. It is expected that political factors will play a central role in state funding of long-term healthcare options (Lowi, 1964). Dependent variables were created for monies allocated to Medicaid dollars distributed to nursing facilities and home healthcare. Each dependent variable was calculated by dividing the FY 2014 spending for each category (Kaiser Family Foundation, 2015a) by the 2014 gross state product (U.S. Department of Commerce, 2015) to get the percentage of the state’s gross state product spent on each program. The selection of independent or control variables was based on policy adoption literature. This framework argues that policy adoption is contingent on politics, state resources, and demand or need within the state. When exploring the impact of politics on policy adoption, there are number of political actors to consider including local officials and agencies. Each of these actors may either work to encourage or discourage the adoption of a particular legislation depending on how they perceive the impact. A number of factors can influence policymaker action(s) including both institutional ideology (elected official ideology) and citizen ideology. Support for increased public assistance funding is more associated with a liberal ideology. It is expected that states where state legislatures and citizens are more liberal, more funding would be allocated to Medicaid programs in the state. In order to control for citizen ideology and institutional ideology two indices were added each ranging from 0 to 100 with higher scores indicating greater liberalism (Fording, 2012). These indices are updated versions of those first proposed by Berry et al (1998). The measure for institutional ideology is constructed using a weighted average of ideological scores for the governor, and the 2 major parties in both houses of the state legislature. Citizen ideology is constructed by averaging ideological scores for incumbents and challengers (or hypothetical challenger) for each state congressional district (Berry et al, 1998, pp. 331-332). Governors can have a significant impact on funding for state programs through institutional powers including their control over the state budget, veto powers and appointment powers. The strength of these institutional powers is measured on a five-point scale where 1 indicates weak and 5 indicates strong (Donovan, Mooney & Smith, 2013). State agencies represent a final set of political actors who have influence over whether a policy is adopted (Goggin et al, 1990). It may be easier to adopt policy if a state has greater control over the resources of the implementing agency. As an indicator of control over state agencies, an index measuring state legislative oversight of the bureaucracy was included. It was constructed using a fourpoint scale where 1 indicates that the state legislature has no oversight power of the bureaucracy and 4 indicates that the legislature can impose costs and / or suspend rules (Gerber, Maestas & Dometruis, 2005). Several measures of state resources were added including urbanization, recession recovery and Medicaid expansion. Urbanization is measured by the percent of the population living in urban areas (United States Census Bureau, 2012a). Recession recovery is an indicator of the extent to which a state 827

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

has “bounced back” from the Great Recession and is operationally defined as the percent difference in state tax revenues between the 3rd quarter of 2009 and the fourth quarter of 2014 (Pew Charitable Trusts, December 10, 2015). Markell (1993) expands the definition of resources to include a strong record of policy implementation of an issue area. As an indicator of whether a state has a record of implementation, a dummy variable was added for whether or not the state adopted to expand Medicaid, coded 1 for yes and 0 for no (Pew Charitable Trusts, July 1, 2014). Finally, Mooney & Lee (1995) argue that public demand or the need for a policy/ program is an important factor in predicting policy adoption. The first measure of need is the change in Medicaid fees, measured as cumulative percent change in Medicaid primary care physician fees 2008-2012 (Kaiser Family Foundation, 2013). It is expected that in states where these fees have risen, the percentage of the gross state product (GSP) earmarked for healthcare programs will be higher. State obligations to non-healthcare policies represent a competing demand for healthcare dollars. It is expected that states with higher obligations, measured (in dollars) as the combined level of unfunded retirement costs and unfunded retiree healthcare costs (Pew Charitable Trusts, May 17, 2016) will have fewer resources to allocate to the Medicaid program. Medicaid enrollment rate for the aged / disabled (Pew Charitable Trusts, July 1, 2014) and the percent increase in citizens age 65+ from 2003 to 2013 (United States Census Bureau, 2014) are demand indicators of the numbers or citizens who need long-term care services as well as a future demand.

Impact of Medicaid Expansion on Home Health Services In Table 2, the Communication Model will act as a blueprint for examining if Medicaid expansion under the Americans with Disability Act of 1990 (ADA) has been instrumental in reallocating more of the Medicaid dollars from nursing facilities to home and community-based services. The dependent variable is the percentage of Medicaid spending on long-term care distributed to home health and personal care for the year 2014 (Kaiser Family Foundation, 2015a). The main independent variables under the Communication Model are federal-level and state-level inducements and constraints. The federal government can compel the states to act through inducements, constraints or a combination of both. Most recently, provisions under the 2010 Patient Protection and Affordable Care Act (ACA) encourage more long-term spending to be allocated toward home and community-based services, emphasized by inducements. In addition to the federal government’s impact on Medicaid long-term care, other stakeholders ranging from the nursing home industry to Americans living with disabilities have played a significant role in shaping state long-term care policy. To control for the possible influence of state-level interests groups, a measure for the overall impact of interest group on the state political system was included. This four-point scale indicates the overall impact that interest groups have in a state political system as related to other groups. A score of 5 indicates that interest groups are dominating in the political system as compared to other groups, and a score of 1 indicates that they are complementary / subordinate (Nownes, Thomas & Hrebenar, 2008). State government officials may choose to ignore “messages” from stakeholders both in and outside of government, based on resources. The ability to ignore these messages is referred to as state capacity (Goggin et al, 1990). There are two forms of state resources: ecological capacity and organizational capacity. Ecological capacity concerns the “contextual environment in which state government operates” (Goggin et al, 1990, p. 911). Similarly, organizational capacity refers to the resources available to the state agency that oversees the policy implementation (Goggin et al, 1990, p. 911). There are three categories of ecological capacity: economical, political, and situational. Economical capacity concerns

828

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

Table 1. State Medicaid spending on long-term care (2014) Variables

Nursing Facilities β (se)

Home Health and Personal Care p>|t|

β (se)

p>|t|

State Political Constraints Governor’s institutional power

-.33(.24)

.185

.50(.26)

.065

Institutional ideology (liberal)

-.01(.01)

.568

.02(.01)

.035

Ideology of citizens (liberal)

-.00(.02)

.956

-.04(.02)

.041

Legislative oversight of bureaucracy

.20(.17)

.238

.17(.18)

.360

State Resources Recession recovery

-.02(.01)

.083

-.02(.01)

.170

Medicaid expansion

.81(.58)

.170

.53(.62)

.399

Urban population (%)

-.04(.02)

.081

-.02(.02)

.375

State Needs/Demands 1.78(1.84)

.340

4.43(1.99)

.031

1.72E-08(1.42E-08)

.235

1.77E-08(1.53E-08)

.254

Medicaid enrollment rate

.11(.05)

.041

.10(.05)

.083

Percent increase population 65+

-.06(.02)

.013

.03(.02)

.181

5.06(2.64)

.063

-.23(2.85)

.935

Adjusted R2

.4546

.0002

.3729

F(11, 38)

4.65

3.65

50

50

Change in Medicaid physician fees State obligations

Constant

N

.0014

Note: Multivariate regression estimates with standard errors in parentheses. Reported probabilities are based on two-tailed tests. Statistically significant coefficients at .10 or less in bold.

the availability of monetary resources. Several measures of state resources were added including recession recovery and education attainment. Educational attainment is measured as the percent of the state population over the age of 25 with a bachelor’s degree or higher (U.S. Census Bureau, 2012b). Measures for governor’s institutional power, citizen ideology and ideology of elected officials (institutional ideology) were added to control for the political capacity. In addition, a measure of female legislators was added since they are more interested in certain policy areas including education, health and welfare as compared to their male counterparts (Bratton & Haynie, 1999). The presence of women legislators is measured using the percent women in a state legislature for each year (Center for American Women and Politics, 2014). The final area of ecological capacity is state situational capacity which refers to citizen demand or need. The percent increase in citizens age 65+ from 2003 to 2013 was used as an indicator of need. Two measures were included for organizational capacity (agency resource); legislative control over the resources of the implementing agency, and state-funded Medicaid expenditures as a percent of state’s own source revenue for the year 2012 (Pew Charitable Trusts, July 1, 2014).

829

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

FINDINGS AND DISCUSSION Determinants of Spending on Long-Term Healthcare In Table 1, the dependent variables are coded so that higher scores are associated with greater allocation of Medicaid funds to long-term healthcare. Since the dependent variables are continuous, multivariate regression analysis is used. The findings in Table 1 suggest that circumstances that lead to Medicaid funds being used for nursing facilities (nursing homes) are quite different from that of home and community-based services (home health and personal care). Specifically, the findings suggest that spending decisions on community-based care is similar to most redistributive type policies in that political factors play the biggest role. On the other hand, political factors do not play a role in state spending decisions for nursing facilities, instead a limited number of state resources and indicators of public need help to predict funding for nursing facilities. The only variables found to be statistically significant in the model for nursing facility funding (Table 1) were state urbanization, state recession recovery, state Medicaid enrollment rate for the aged / disabled, and the percent increase in residents age 65+ from 2003 to 2013. The finding that no political factors were significant for the regression model on nursing facility Medicaid funding is not the only result that was unexpected. While the policy adoption literature argues that greater state wealth is associated with policy action, the findings suggest that poorer states were more likely to provide greater Medicaid funding to their nursing facilities. Urbanism is an indicator of state wealth (Walker, 1969), but the model indicated that rural states were more likely to provide greater funding for costly nursing facilities. One explanation is that rural states have both fewer care providers and established community care industries to provide home health services, due to geography issues (Schmeida, 2005). Although recession recovery was added as an indicator of state wealth, the finding that it is negatively associated with nursing facility spending suggests it is acting as a measure of need. States who have “bounced back” from the Great Recession are allocating fewer Medicaid dollars to nursing facilities. It is likely that recovered economy states have fewer people in need of public assistance, including Medicaid. As predicted, as more seniors / disabled citizens are Medicaid enrolled, greater spending is made by the state to nursing facilities. However, it is counterintuitive that as the percent of people age 65+ increases that less Medicaid money is allocated. One possible explanation is that there is a “tipping point” where once public spending to costly nursing facilities reaches a certain percentage of the state budget, public officials look into less costly policy alternatives, such as home and community based long-term care services. Unlike funding to nursing facilities, state political factors were found to play an important role in Medicaid funding of community home health and personal care services, see Table 1. The political factors relevant to funding include governor’s institutional power, citizen ideology and institutional ideology. At first glance, it seems puzzling that states with conservative citizens and liberal legislators would allocate more long-term Medicaid dollars to community-based care. A possible explanation is framing. Groups who want a particular policy to be adopted or rejected may try to influence how it is depicted or framed in order to get a preferred outcome. There are a number of groups involved in the battle over how to best address the growing demand for long-term care, ranging from the nursing home industry to persons with disabilities. Their strong arguments (cost containment and civil right to choose the care setting) are encouraging the transition into community-based care. These arguments appeal to individuals on both the left and right. The finding that states with more powerful governors are associated with more spending toward community-based care emphasizes their role in the budget making process. Unlike 830

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

spending on nursing home facilities, state resources were not found to play a role in community-based care spending. In addition, only two need / demand factors were found to be statistically significant. As found with the public spending on nursing facilities regression model, as more seniors / disabled citizens are Medicaid enrolled there is greater state spending on community home health and personal care. Finally, the fee change for primary physicians was found to be positively associated with greater spending on community-based care. This suggests that costly physician service plays an important part in long-term care spending decisions made by states. As physician costs increases, states are shifting public funding to less expensive long-term care alternatives.

Impact of the Medicaid Expansion on Home Health and Personal Care Services In Table 2, the dependent variable is coded so that higher scores are associated with a greater percent of Medicaid long-term care funding being allocated to community home health and personal care services. Since the dependent variables are continuous, multivariate regression analysis is used. The findings suggest that for this policy area, the state-level interest groups and ecological capacity are dominating “communication” with regard to long-term care policy discussion. Expanding Medicaid long-term care services was not found to be a statistically significant predictor of whether states spend more of their overall long-term care Medicaid dollars on community-based care or traditional nursing facilities. This occurs despite several enhanced funding options provided by ACA for home and community-based services (HCBS). There are several possible explanations for this finding. First, as Goggin et al. (1990) argue, states may elect to ignore the messages from other political actors and choose to enact their own policy preferences. In the long-term care issue area, the states may be listening to other powerful actors, such as the nursing home industry. At the state-level, the nursing home industry has become an increasingly powerful lobbying force. In 1985, hospitals / nursing homes were ranked 17th among the 20 most influential interests at the state-level; by 2007 this industry rose to 5th in the rankings (Nownes, Thomas & Hrebenar, 2008, p. 117). As a second explanation, this study used a fairly rudimentary measure for the Goggin et al. (1990) concept of state-level inducements and constraints. A dummy variable was used to indicate whether the state had expanded Medicaid. Whereas, a measure of the amount of enhanced funding received under the Americans with Disability Act of 1990 for long-term care HCBS may have shown a relationship between Medicaid expansion and spending on community-based care. Although the federal government was found not related to how Medicaid spending was allocated, state-level actors were related. In states where interests groups are more powerful, states spent a greater percent of their long-term care Medicaid dollars on community-based care. This is not surprising, given the history of interest group advocacy related to this policy. Although states may decide to ignore messages from other political actors, their ability to do so is based on state resources (state capacity). Four measures were included to control for the state political environment. Consistent with findings in Table 1, liberal state legislatures and powerful governors were found to be associated with a greater percent of long-term funding being allocated to community home health and personal care. Unexpected was the finding that citizen ideology was not related to spending allocations, and the percent of women in the state legislature was negatively related. Possibly, states with more women in their state legislature tend to be ones where the legislature is less powerful (Squire, 1992). In these states, the executive branch will have greater control over policy. Two measures were included for state wealth with mixed results. States with higher education attainment among their citizens were found more likely to allocate more monies to community home health and personal services, whereas

831

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

Table 2. Percent of Medicaid long-term care spending distributed to home health and personal care (2014) Percent of Spending on Home Health and Personal Care

Variables

β (se)

p>|t|

Federal-Level Inducements and Constraints Medicaid expansion

-1.97(6.11)

.749

State-Level Inducements and Constraints 5.48(2.95)

.071

Institutional ideology (liberal)

.31(.09)

.002

Ideology of citizens (liberal)

-.07(.23)

.754

Percent women in the state legislature

-1.19(.56)

.042

Governor’s institutional power

6.47(2.26)

.007

1.68(.88)

.063

.17(.11)

.119

.98(.23)

.000

State legislative oversight of bureaucracy

-2.86(1.71)

.102

State funded Medicaid expenditures

1.13(1.12)

.320

-139.40(71.71)

.059

Overall interest group impact Ecological Capacity Political

Economical Percent with a high school degree Recession recovery Situational Percent increase population 65+ Organizational Capacity

Constant Adjusted R F(11, 38) N

2

.4087 4.08

.0006

50

Note: Multivariate regression estimates with standard errors in parentheses. Reported probabilities are based on two-tailed tests. Statistically significant coefficients at .10 or less in bold.

there was no relationship between spending and recession recovery. These findings are consistent with Table 1 that shows funding decisions on community care is characteristic of redistributive policy where political factors take a lead over other factors. The percent increase in citizens age 65+ from 2003 to 2013 was included as an indicator of need (situational capacity) and found to be positively associated with the percent of Medicaid dollars allocated to long-term care home health and personal services. This is supported by findings in Table 1 suggesting there is a “tipping point” where once public spending to nursing homes becomes untenable, state public officials explore alternative less costly policy solutions. Finally, unlike ecological capacity, none of the measures of organizational resources were found related to long-term care spending decisions. Our findings are similar to other intergovernmental social policy research. Goggin (1999) studied the State Children’s Health Insurance Program (Public Law 105-33, 1997) for poor children and pregnant women. Much like ACA Medicaid expansion, it also has federal financial incentives for states to expand coverage (P.L. 105-33; NSCL, 2017). He found the state political environment to play the biggest role in

832

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

whether states chose to implement the program, which is consistent with our study on state expansion of Medicaid coverage for long-term healthcare. One possible explanation for the similarity is the political realities of the U.S. Even though government health insurance exists, healthcare insurance has been mostly treated as a private good in the U.S. with employer-based insurance being the dominant. Today, there is a significant division between the Democratic and Republican Parties on the proper role of the government in ensuring access to healthcare.

Monte Carlo Simulations To further explore the impact of factors suggested by the Communication Model on how states are distributing Medicaid spending on long-term care, the predicted percentage (probability estimates) of Medicaid long-term care spending allocated to home health and personal care from Table 2 are presented in Tables 3 and 4. While the findings in Table 2 show a number of state-level variables played a significant role in how states distributed their long-term care spending, we chose interest group strength, institutional ideology and the increase in population 65+ years for further study. Variables selected were limited to those found as statistically significant. Non-selected were those under the categories of federal-level inducements and constraints or organizational capacity since they were not significant. Interest group strength was included because it was the only variable in the model for state-level inducement and constraints, in addition to being statistically significant. Whereas, there were a number of variables under the category of ecological capacity found to be significant with state spending on community home health and personal care. We selected institutional ideology and increase in population 65+ years for further analysis because they had the lowest p-value. To illustrate the impact of these variables, the coefficients reported in Table 2 were converted to predicted percentage (probability estimates) of state Medicaid long-term care spending allocated to home health and personal care using the Clarify; one of many examples of Monte Carlo simulation approaches (King, Tomz, & Wittenberg, 2000). Monte Carlo simulation describes computer algorithms that draw a large numbers of random samples from probability distributes and uses these samples to help generate estimates (King, Tomz, & Wittenberg, 2000, p. 349). Table 3 explores the impact of interest group strength and the institutional ideology on predicted percentage of Medicaid long-term care spending (on community home health and personal care). Table 4 considers the impact of interest group strength and increase in population 65+ years on the predicted percentage of the Medicaid long-term care community spending. Table 3. The impact of interest group strength and institutional ideology on the predicted percentage of Medicaid long-term care spending on community home health and personal care (2014) Interest Group Strength/ Institutional Ideology

Complementary/ Subordinate

Complementary

Dominant/ Complementary

Dominant

High (liberal)

40.4% (7.06)

46.0% (5.58)

51.6% (5.43)

57.2% (6.71)

Mean

30.9% (6.59)

36.5% (4.82)

42.1% (4.49)

47.7% (5.85)

Low(conservative)

29.8% (6.61)

35.4% (24.84)

41.0% (4.49)

46.6% (5.83)

10.6%

10.6%

10.6%

10.6%

Difference (high-low)

833

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

Table 4. Impact of interest group strength and increase in population 65+ on the predicted percentage of Medicaid long-term care spending on community home health and personal care (2014) Interest Group Strength/Increase in Percent of Population Over Age 65 High

Complementary/ Subordinate

Complementary

Dominant/ Complementary

Dominant

43.0% (7.21)

48.6% (5.43)

54.2% (4.91)

59.8% (5.98)

Mean

30.9% (6.59)

36.5% (4.82)

42.1% (4.49)

47.7% (5.85)

Low

18.9% (7.16)

24.5% (5.78)

30.1% (5.71)

35.7% (7.00)

24.1%

24.1%

24.1%

24.1%

Difference (high-low)

Note: Standard errors are in parentheses. To simulate different levels of increase in population 65+, the population increase was set at one standard deviation below the mean, mean, and one standard deviation above the mean. Value for percent women in the state legislature, percent of the population over 25 with a high school degree, institutional ideology, citizen ideology, recession recovery and state funded Medicaid expenditures were set at their mean. Values for governor’s power, Medicaid expansion and legislative oversight were set at their median. Estimations were produced using Clarify: Software for Interpreting and Presenting Statistical Results, by Michael Tomz, Jason Wittenberg, and Gary King (2000).

IMPACT OF INTEREST GROUP STRENGTH AND THE INSTITUTIONAL IDEOLOGY Table 3 presents the predicted percentages (probability estimates) of Medicaid long-term care spending allocated to community home health and personal care with varying levels of state-level interest group strength and institutional ideology. Institutional ideology was set at one standard deviation above the mean, the mean, and one standard deviation below the mean while interest group strength was set at its four categories ranging from complementary/subordinate to dominant. The remaining control variables were set at their mean if they are continuous variables and categorical variables were set at their median. The probability estimates show in states where the legislature is more liberal and interest groups strength relative to other actors (including political parties) is stronger, state allocation of Medicaid long-term care spending to community home health and personal care is more likely to be higher. The percentage of funds allocated to home health and personal care increases by roughly 17% when comparing states where interest groups are dominant to those where interest groups are complementary/ subordinate. Similarly, in states where the legislature is more liberal (set at one standard deviation above the mean on the ideological scale), the percent of funds dedicated to home health and personal care increases by approximately 10.6% when compared to more conservative state legislatures (set at one standard deviation below the mean on the ideological scale). Taken together, these findings show the important role political actors play in determining how Medicaid dollars will be spent. Note: Standard errors are in parentheses. To simulate different levels of institutional ideology, ideology was set at one standard deviation below the mean, mean, and one standard deviation above the mean. Value for percent women in the state legislature, percent of the population over 25 with a high school degree, percent increase in population 65+, citizen ideology, recession recovery and state funded Medicaid expenditures were set at their mean. Values for governor’s power, Medicaid expansion and legislative oversight were set at their median. Estimations were produced using Clarify: Software for Interpreting and Presenting Statistical Results, by Michael Tomz, Jason Wittenberg, and Gary King (2000).

834

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

IMPACT OF INTEREST GROUP STRENGTH AND THE INCREASE IN POPULATION AGE 65+ Table 4 presents the predicted percentages of Medicaid long term care spending allocated to community home health and personal care with varying levels of interest group strength and percent increase in population age 65+ (from 2003 to 2013). Increase in population 65+ was set at one standard deviation above the mean, the mean, and one standard deviation below the mean while interest group strength was set at its four categories ranging from complementary/ subordinate to dominant. The remaining control variables were set at their mean if they are continuous variables and categorical variables were set at their median. The probability estimates show in states where the population is aging and interest groups strength relative to other actors (including political parties) is stronger, state allocation of Medicaid long-term spending to community home health and personal care is more likely to be higher. As with Table 3, the percent of funds allocated to home health and personal care increased by roughly 17% when comparing states where interest groups are dominant to those where interest groups are complementary/ subordinate. Similarly, in states where the percentage increase of citizens 65+ is high (set at one standard deviation above the mean on the ideological scale), the percent of funds dedicated to home health and personal care increases by approximately 24% when the percent increase of citizens 65+ is low (set at one standard deviation below the mean on the ideological scale). Similar to Table 3, these findings show the important role political actors (interest groups) play in the allocation of long-term care Medicaid funds.

SOLUTIONS AND RECOMMENDATIONS In 1965, Congress passes Medicaid at the urging of President Lyndon B. Johnson. Although this joint federal-state public assistance program helped bring needed healthcare to the aged poor, children and those living with disabilities, one provision soon came under fire. Both state officials and citizens raised concern about the lack of long-term care alternatives. By the 1970’s, state officials found the payments to nursing facilities (nursing homes) continued to inflate their contributions to the Medicaid program. In addition, a series of scandals on the poor quality of care in nursing facilities had citizens demanding alternatives for long-term care. In 1981, the federal government began permitting states to use long-term care Medicaid funds for home and community-based services (HCBS) as an alternative to facilities. Overtime, many states have begun allocating more of their long-term care Medicaid funds to HCBS. How do we further increase the use of the nursing facility alternative across the states? One solution is for the federal government to give states greater financial incentive to move aged enrollees from costly nursing facilities back into the community for long-term care services. This recommendation is not supported by the findings of this study that shows federal incentives are unrelated to how Medicaid long-term care monies are allocated at the state-level. This might be a function of how federal incentives were measured in this study. Another answer is the continued interest group advocacy. A number of interests ranging from persons living with disabilities to average citizens concerned about nursing home quality have been instrumental in changing long-term Medicaid funding. Also, similar to other redistributive policies, this research found political actors to play a leading role in policy implementation. A final suggestion is to build public education. Often, long-term healthcare decisions are made by family abruptly following a medical event of a member, not in a position to carefully evaluate alternative long-term care options. Government agencies representing the aged are in a visible position to prepare the public for future long-term care needs of family, educating the public on care options. 835

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

FUTURE RESEARCH DIRECTIONS What explains the difference in how states have responded to the federal government’s encouragement to expand home and community-based services? Does the 2010 Patient Protection and Affordable Care Act (ACA) play an important role in this difference? This research represents an initial attempt at exploring these questions. The findings suggest that this policy area has responded like a classic redistributive policy in that political factors, more so than other factors, have determined how states allocate long-term care Medicaid healthcare dollars. This further suggests that federal inducements under ACA are not what is motivating state action in this policy area. It should be understood that these findings are preliminary. This chapter used a fairly blunt instrument to measure federal inducements to states. It was coded 1 if a state had expanded Medicaid long-term care services under the ACA and 0 otherwise. This measure of federal inducement did not indicate how much additional monies a state received following the decision to expand Medicaid HCBS. In addition, there are other federal grants that encourage the expansion of HCBS, such as Real Choice System Change grants. This study focused on the impact of ACA on the states, but future research may consider the impact of other federal programs encouraging alternative options to traditional nursing home facilities. Furthermore, the Communication Model (Goggin et al., 1990) is designed to depict state-level policy implementation over time. This study only explores the impact of the ACA on long-term care options for the year 2014. Future research can improve upon this initial study by using a time-series approach. Finally, recent U.S. elections have brought in a new presidential administration (Donald Trump), where discussions are underway to make changes to ACA and Medicaid. The extent to which these changes will affect HCBS will require an evaluation.

CONCLUSION Citizens are living longer, and meeting the care demands of an aging population is a fiscal challenge. This research explores one policy solution used in the United States to meet the demands of the aged: home and community-based services. Initially, Medicaid as the U.S. healthcare system for the poor limited public long-term care funding to nursing facilities. Within a few years of the 1965 Medicaid policy adoption, demands for an alternative to nursing facilities developed coming from citizen and public officials alike. Since 1981, the federal government has permitted states to use Medicaid long-term care dollars for both costly nursing facilities and alternative settings such as home and community-based services. Since community based care is often less costly and preferred by citizens, it would be expected that Medicaid funding for nursing facilities would soon dwindle. This has not happened; in some states communitybased care is replacing the facilities, while in other states the nursing home facilities still receive the lion share of Medicaid long-term care dollars. Since Medicaid is a form of public assistance considered a redistributive policy, it was expected that the answer would be dominated by political factors (Lowi, 1964). The findings supported this prediction to an extent; greater funding of community-based care in the states was primarily explained by political factors and increased fiscal demands on the state. On the other hand, state resources and demand factors best explained which states continued to heavily fund nursing facilities. In addition, the findings did not suggest that federal grants such as those available through the Americans with Disability Act of 1990 impacted state decision on this policy question. The finding that political factors were important to the expansion of expenditures for home and community-based services and not nursing home facilities suggests that the facilities have become the default option. It is

836

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

the option adopted by the states unless political actors force a change. Intrastate interest group advocacy efforts rather than federal level monetary inducements matter more in expanding home and community based long-term care services. This study relied on the Communication Model to frame the exploration of why some states continue to spend more revenue on traditional nursing facility care while other states are spending more on HCBS. Over the years a number of studies have used this model as a guide for exploring intergovernmental policies. While Goggin et. al. (1990) had hoped that use of their Communication Model would ultimately lead to a generalizable theory of implementation, it hasn’t happened. Instead, individual studies have resulted in findings that point to variables distinctive to each policy area (Winters, 2006). The same is true for this study; the findings from this study are unique to the area of government sponsored healthcare insurance. That does not lessen the usability of the Communication Model. Even though its subsequent use has not resulted in a generalizable theory of implementation, it is a useful heuristic for exploring intergovernmental policy.

REFERENCES Berry, W., Ringquist, E., Fording, R., & Hanson, R. (1998). Measuring citizen and government ideology in the American states, 19601993. American Journal of Political Science, 42(1), 327–348. doi:10.2307/2991759 Bratton, K., & Haynie, K. (1999). Agenda setting and legislative success in state legislatures: The effects of gender and race. The Journal of Politics, 61(3), 658–679. doi:10.2307/2647822 Center for American Women and Politics. (2014). Women in state legislatures. Retrieved July 15, 2014, from http://www.cawp.rutgers.edu Centers for Medicare & Medicaid Services, Office of the Actuary. (2014). Report to congress. 2014 actuarial report on the financial outlook for Medicaid. Retrieved July 5, 2016, from http://www.medicaid.gov/medicaid-chip-program-information/by-topics/financing-and-reimbursement/downloads/ medicaid-actuarial-report-2014.pdf Centers for Medicare and Medicaid Services. (2015). Brief summaries of Medicare & Medicaid Title XVIII and Title XIX of the Social Security Act. Retrieved July 5, 2016, from http://www.cms.gov/ResearchStatistics-Data-and-Systems/Statistics-Trends-and-Reports/MedicareProgramRatesStats/Downloads/ MedicareMedicaidSummaries2015.pdf Cline, K. (2003). Influences on intergovernmental implementation: The states and the superfund. State Politics & Policy Quarterly, 3(1), 66–83. Donovan, T., Mooney, C., & Smith, D. (2013). State and local politics: Institutions and Reforms (3rd ed.). Stamford, CT: Cengage Learning. Dotterweich-Bryan, L., & McNeal, R. (2004). No child left behind: the report card—why are some states successfully implementing new law and others not? Paper at the meeting of the Fourth Annual State Politics and Policy Conference, Cuyahoga Falls, OH.

837

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

Fording, R. (2012). State ideology data. Retrieved June 15, 2014, from http://rcfording.wordpress.com/ state-ideology-data/ Gerber, B., Maestas, C., & Dometrius, N. (2005). State legislative influence over agency rulemaking: The utility of ex ante review. State Politics & Policy Quarterly, 5(1), 24–46. doi:10.1177/153244000500500102 Goggin, M. (1999). The use of administration discretion in implementing the State Childrens Health Insurance Program. Publius, 29(2), 35–51. doi:10.1093/oxfordjournals.pubjof.a030025 Goggin, M., Bowman, A., Lester, J., & O’Toole, L. (1990). Implementation theory and practice: toward a third generation. New York, N.Y.: Harper Collins Publishers. Gray, V. (1973). Innovations in the states: A diffusion study. The American Political Science Review, 67(4), 1174–1185. doi:10.2307/1956539 Hwang, S., & Gray, V. (1991). External limits and internal determinants of state public policy. The Western Political Quarterly, 44(2), 277–299. doi:10.2307/448779 Kaiser Family Foundation. (2013). Cumulative percentage change in Medicaid fees, by type of service timeframe: 2008-2012. Retrieved June 10, 2016, from http://kff.org/medicaid/state-indicator/changein-medicaid-fees/ Kaiser Family Foundation. (2013). Cumulative percentage change in Medicaid fees, by type of service timeframe: 2008-2012. Retrieved June 10, 2016, from http://kff.org/medicaid/state-indicator/changein-medicaid-fees/ Kaiser Family Foundation. (2015a). Distribution of Medicaid spending on long-term care. Retrieved June 10, 2016, from http://kff.org/medicaid/state-indicator/spending-on-long-term-care/ Kaiser Family Foundation. (2015b). State action on Medicaid expansion as of April 2015. Retrieved June 10, 2016, from http://kff.org/health-reform/state-indicator/state-activity-around-expanding-medicaidunder-the-affordable-care-act/ Kaiser Family Foundation. (2015c). Medicaid financing: how does it work and what are the implications? Retrieved June 10, 2016, from http://kff.org/medicaid/issue-brief/medicaid-financing-how-doesit-work-and-what-are-the-implications/ Kaiser Family Foundation. (2015d). Long-term care in the United States: a timeline. Retrieved June 10, 2016, from http:// kff.org/medicaid/timeline/long-term-care-in-the-united-states-a-timeline/ Kaiser Family Foundation. (2015e). Medicaid enrollment & spending growth: FY 2015 & 2016. Retrieved June 10, 2016, from http:// kff.org/medicaid/issue-brief/medicaid-enrollment-spending-growthfy-2015-2016/ Kaiser Family Foundation. (2015f). Putting Medicaid in the larger budget context: an in-depth look at three states in FY 2015 and 2016, Alaska. Retrieved June 10, 2016, from http://kff.org/report-section/ putting-medicaid-in-the-larger-budget-context-an-in-depth-look-at-three-states-in-fy-2015-and-2016alaska/

838

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

Kaiser Family Foundation. (2015g). Putting Medicaid in the larger budget context: an in-depth look at three states in FY 2015 and 2016, California. Retrieved June 10, 2016, from http://kff.org/report-section/ putting-medicaid-in-the-larger-budget-context-an-in-depth-look-at-three-states-in-fy-2015-and-2016california/ Kaiser Family Foundation. (2015h). Medicaid and long-term services and supports: a primer. Retrieved June 10, 2016, from http:// kff.org/medicaid/report/medicaid-and-long-term-services-and-supports-aprimer/ Kane, R. A. (2012). Thirty years of home- and community-based services: Getting closer and closer to home. Generations (San Francisco, Calif.), 36(1), 6–13. King, G., Tomz, M., & Wittenberg, J. (2000). Making the most of statistical analysis: Improving interpretation and presentation. American Journal of Political Science, 44(2), 347–361. doi:10.2307/2669316 Lowi, T. (1964). American business, public policy, case studies, and political theory. World Politics, 16(4), 667–715. doi:10.2307/2009452 Lowi, T. (1979). The end of liberalism: the second republic of the United States. New York: W.W. Norton & Company, Inc. Markell, D. (1993). The federal superfund program: Proposals for strengthening the federal/state relationship. William and Mary Journal of Environmental Law, 18, 1–82. Mathematica Policy Research. (2014). The changing medical and long-term care expenditures of people who transition from institutional care to home- and community-based services. Retrieved July 5, 2016, from https://www.mathematica-mpr.com/our-publications-and-findings/publications/the-changingmedical-and-long-term-care-expenditures-of-people-who-transition McNeal, R. (2012). State response to Obama’s broadband access policy: a study in policy implementation. In V. Weerakkody & C. Reddick (Eds.), Public sector transformation through e-government: experiences from Europe and North America. Routledge. Medicaid and CHIP Payment and Access Commission (MACPAC). (2014). Report to Congress on Medicaid and CHIP. Retrieved July 14, 2016, from http://www.macpac.gov/reports Meier, K. (1994). The politics of sin: drugs, alcohol and public policy. New York: Sharpe. Mooney, C., & Lee, M. (1995). Legislating morality in the American states: The case of pre-Roe abortion regulation reform. American Journal of Political Science, 39(3), 599–627. doi:10.2307/2111646 National Conference of State Legislatures. (2011). Long-term care provisions in health reform. Retrieved June 10, 2016, from http://www.ncsl.org/research/health/long-term-care-provisions-in-health-reform.aspx National Conference of State Legislatures. (2017). Children’s health insurance program overview. Retrieved February 15, 2017, from http://www.ncsl.org/research/health/childrens-insurance-programoverview.aspx

839

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

Nownes, A., Thomas, C., & Hrebenar, R. (2008). Interest groups in the states. In V. Grey & R. Hanson (Eds.), Politics in the American states: A comparative analysis (9th ed.; pp. 98–126). Washington, DC: CQ Press. Olmstead v. L.C. (98-537) 527 U.S. 581 (1999) Pew Charitable Trusts. (2014). State health care spending on Medicaid: a 50-state study of trends and drivers of cost. Retrieved June 12, 2016, from http://www.pewtrusts.org/en/Multimedia/Data-Visualizations/2014/Medicaid-Spending-Growth Pew Charitable Trusts. (2015). For first time, tax revenue has recovered in majority of states. Retrieved June 12, 2016, from http:// www.pewtrusts.org/en/research-and-analysis/analysis/2015/12/10/for-firsttime-tax-revenue-has-recovered-in-majority-of-states Pew Charitable Trusts. (2016a). Reserves remain short of pre-recession levels in most states. Retrieved June 12, 2016, from http://www.pewtrusts.org/en/research-and-analysis/analysis/2016/01/05/reservesremain-short-of-pre-recession-levels-in-most-states Pew Charitable Trusts. (2016b). Is Medicaid expansion near a tipping point? Retrieved June 12, 2016, from http://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2016/01/26/is-medicaid-expansion-near-a-tipping-point Pew Charitable Trusts. (2016c). Revenue is up in most states; but weak forecasts prompt caution. Retrieved June 12, 2016, from http://www.pewtrusts.org/en/research-and-analysis/blogs/stateline/2016/01/27/ revenue-is-up-in-most-states-but-weak-forecasts-prompt-caution Pew Charitable Trusts. (2016d). Fiscal 50. Retrieved June 12, 2016, from http:// www.pewtrusts.org/en/ multimedia/data-visualizations/2014/fiscal-50 Public Law 101-336. (1990). Americans with Disability Act of 1990. Public Law 105-33. (1997). The Children’s Health Insurance Program. Public Law 109-171. (2005). Deficit Reduction Act of 2005. Public Law 111–148. (2010). Patient Protection and Affordable Care Act. Public Law 111-5. (2009). American Recovery and Reinvestment Act of 2009. Public Law 74-271. (1935). Social Security Act of 1935. Public Law 89-97. (1965). Social Security Amendments of 1965. Ripley, R., & Franklin, G. (1980). Congress, the bureaucracy, and public policy. Homewood, IL: The Dorsey Press. Rockefeller Institute of Government. (2016). State revenue report no. 102. softening third-quarter growth in state taxes, weak forecasts for fiscal 2016 and 2017. Retrieved July 1, 2016, from http://www.rockinst.org Schmeida, M. (2005). Telehealth innovation in the American states. Ann Arbor, MI: ProQuest.

840

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

Schmeida, M., & McNeal, R. (2015). Online health information: home caregiver population driving cyberspace searches in the United States. In M. Khosrow-Pour (Ed.), Public affairs and administration: concepts, methodologies, tools, and applications (pp. 1664–1683). Hershey, PA: Information Science Reference. doi:10.4018/978-1-4666-8358-7.ch085 Squire, P. (1992). Legislative professionalism and membership diversity in state legislatures. Legislative Studies Quarterly, 17(1), 69–79. doi:10.2307/440081 United States Census Bureau. (2012a). 2010 Census urban and rural classification and urban area criteria. Retrieved November 7, 2013, from http://www.census.gov/geo/reference/ua/urban-rural-2010.html United States Census Bureau. (2012b). 2012 statistical abstract. Retrieved December 9, 2013, from http://www.census.gov/compendia/statab/ United States Census Bureau. (2014). Statistical abstracts in the United States. Washington, DC: U.S. Government Printing Office. United States Department of Commerce, Bureau of Economic Analysis. (2015). GSP missions of current 2014 dollars. Retrieved June 1, 2016, from http://www.bea.gov United States Department of Health and Human Services, Administration of Aging. (2014). A profile of older Americans: 2014. Retrieved June 12, 2016, from http://www.aoa.acl.gov/aging_statistics/profile/2014/docs/2014-profile.pdf United States Government Accountability Office. (2011). Medicaid improving responsiveness of federal assistance to states during economic downturns. Report GAO-11-395. Retrieved June 12, 2016, from http:// www.gao.gov/assets/320/317275.pdf United States Government Accountability Office. (2015a). Medicaid key issues facing the program. report to congressional addressees. Report GAO-15-677. Retrieved June 12, 2016, from http:// www. gao.gov/assets/680/671761.pdf United States Government Accountability Office. (2015b). Medicaid managed care trends in federal spending and state oversight of costs and enrollment. Report GAO-16-77. Retrieved June 12, 2016, from http://gao.gov/assets/680/674307.pdf Urban Institute. (2014). Reversing the Medicaid fee bump: how much could Medicaid physician fees for primary care fall in 2015? Retrieved July 5, 2016, from http://www.urban.org/sites/default/files/alfresco/ publication-pdfs/2000025-Reversing-the-Medicaid-Fee-Bump.pdf Walker, J. (1969). The diffusion of innovation among the American states. The American Political Science Review, 63(3), 880–899. doi:10.2307/1954434 Winters, S. (2006). Implementation. In B. Peters & J. Pierre (Eds.), The SAGE handbook of public policy (pp. 151–166). London: Sage. doi:10.4135/9781848608054.n9 World Health Organization. (2014). “Ageing well” must be a global priority. Retrieved July 5, 2016, from http://www.who.int/mediacentre/news/releases/2014/lancet-ageing-series/en/

841

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

ADDITIONAL READING Degenholtz, H. B., Park, M., Kang, Y., & Nadash, P. (2016). Variations among Medicare beneficiaries living in different settings. Research on Aging, 38(5), 602–616. doi:10.1177/0164027515598557 PMID:26269562 Doty, P., Liu, K., & Wiener, J. (1985). Special report: An overview of long-term care. Health Care Financing Review, 6(3). PMID:10311163 Duckett, M., & Guy, M. (2000). Home and community-based services waivers. Health Care Financing Review, 22(1), 123–125. PMID:25372343 Kaiser Family Foundation. (2012). The cost and coverage implications of the ACA Medicaid expansion: national and state-by-state analysis. Retrieved June 10, 2016, from http://kaiserfamilyfoundation.files. wordpress.com/2013/01/8384.pdf Kaiser Family Foundation. (November 25, 2013). The role of Medicaid in state economies: a look at the research. Retrieved June 10, 2016, from http://kff.org/medicaid/issue-brief/the-role-of-medicaid-instate-economies-and-the-aca/ Kaiser Family Foundation. (October 15, 2015). The Affordable Care Act drove record annual increases in enrollment and total Medicaid spending nationally in FY 2015, as newly eligible adults gained coverage in expansion states. Retrieved June 10, 2016, from http://kff.org/medicaid/press-release/the-affordablecare-act-drove-record-annual-increases-in-enrollment-and-total-medicaid-spending-nationally-in-fy2015-as-newly-eligible-adults-gained-coverage-in-expansion-states/ Kaiser Family Foundation. (October 15, 2015). Putting Medicaid in the larger budget context: an indepth look at three states in FY 2015 and 2016, Tennessee. Retrieved June 10, 2016, from http://kff. org/report-section/putting-medicaid-in-the-larger-budget-context-an-in-depth-look-at-three-states-infy-2015-and-2016-tennessee/ Kaiser Family Foundation. (2016). State health facts, federal medical assistance percentage (FMAP) for Medicaid and multiplier. Retrieved June 10, 2016, from http://kff.org/medicaid/state-indicator/federalmatching-rate-and-multiplier/ Kaiser Family Foundation. (January, 2016). Americans’ views on the U.S. role in global health. Retrieved June 10, 2016, from http://kff.org/global-health-policy/poll-finding/americans-views-on-the-u-s-rolein-global-health/ Kane, R. L. (2015). A new long-term care manifesto. The Gerontologist, 55(2), 296–301. doi:10.1093/ geront/gnv010 PMID:26035606 Kane, R. L., & Kane, R. A. (2015). The long view of long-term care: Our personal take on progress, pitfalls, and possibilities. Journal of the American Geriatrics Society, 63(11), 2400–2406. doi:10.1111/ jgs.13659 PMID:26515277 Kennedy, M. (2013). Community-based health plans take the (complex) path to integrated care. Generations (San Francisco, Calif.), 37(2), 30–32.

842

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

Mahoney, K. J., Sciegaj, M., & Mahoney, E. K. (2014). The future of participant direction in aging services. Generations (San Francisco, Calif.), 38(2), 85–93. Miller, E. A., & Rudder, C. (2013). Engaging consumers in Medicaid nursing home reimbursement policy: Lessons from New York and Minnesota. The Gerontologist, 53(4), 627–640. doi:10.1093/geront/ gns141 PMID:23125075 Miller, S. C., Cohen, N., Lima, J. C., & Mor, V. (2014). Medicaid capital reimbursement policy and environmental artifacts of nursing home culture change. The Gerontologist, 54(Supplement 1), S76–S86. doi:10.1093/geront/gnt141 PMID:24443609 National Association of Medicaid Directors. (November, 2015). State Medicaid operations survey: fourth annual survey of Medicaid directors. Retrieved July 5, 2016, from http://www.statecoverage.org/files/ NAMD_Medicaid_Survey_Report_2015.pdf National Health Policy Forum. (October 17, 2013). The commission on long-term care: background behind the mission. Retrieved July 5, 2016, from http://www.nhpf.org Organisation for Economic Co-operation and Development (OECD). (2009). The long-term care workforce: overview and strategies to adapt supply to a growing demand. Paris: OCED. Retrieved July 5, 2016, from http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?doclanguage=en&cot e=delsa/elsa/wp2/hea (2009)1 Pew Charitable Trusts. (July 29, 2015). State spending on Medicaid. Retrieved June 12, 2016, from http://www.pewtrusts.org/en/research-and-analysis/analysis/2015/07/29/state-spending-on-medicaid Pew Charitable Trusts. (December, 2015). Why states save using evidence to inform how large rainy day funds should grow. Retrieved June 12, 2016, from http://www.pewtrusts.org/~/media/assets/2015/12/ whystatessavereport.pdf / Pew Charitable Trusts. (February, 2016). Insights from fiscal 50’s key measures of state fiscal health. Retrieved June 12, 2016, from http://www.pewtrusts.org/en/research-and-analysis/analysis/2015/11/11/ insights-from-fiscal-50s-key-measures-of-state-fiscal-health Pew Charitable Trusts. (May 17, 2016). Long-term obligations vary as a share of state resources. Retrieved June 12, 2016, from http://www.pewtrusts.org/en/research-and-analysis/analysis/2016/05/17/ long-term-obligations-vary-as-a-share-of-state-resources Popejoy, L. L. (2015). Comparing aging in place to home health care: Impact of nurse care coordination on utilization and costs. Nursing Economics, 33(6), 306–313. PMID:26845818 Public Law 110-246. (2008). The Older Americans Act. Public Law 89-73. (1965). Older Americans Act. Reinhard, S. C. (2013). What do older adults want from integrated care? Generations (San Francisco, Calif.), 37(2), 68–71.

843

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

Rockefeller Institute of Government. (November, 2015). State revenue report no. 101. another strong tax quarter for the states, but less promising forecasts for fiscal 2016. Retrieved July 1, 2016, from http:// www.rockinst.org Rockefeller Institute of Government. (April, 2016). Will April income tax returns surprise states? Retrieved July 1, 2016, from http://www.rockinst.org Salganicoff, A. (2015). Women and Medicare: An unfinished agenda. Generations (San Francisco, Calif.), 39(2), 43–50. Stevens, A. B., Hochhalter, A. K., Basu, R., Smith, E. R., Thorud, J. L., Jo, C., & McGhee, R. (2015). A model program of community-based supports for older adults at risk of nursing facility placement. Journal of the American Geriatrics Society, 63(12), 2601–2609. doi:10.1111/jgs.13831 PMID:26663134 United States Census Bureau. (May, 2010). The next four decades, the older population in the United States: 2010 to 2050. Retrieved June 12, 2016 from http://www.census.gov/prod/2010pubs/p25-1138.pdf United States Department of Commerce. Census Bureau. (November, 2011). The older population: 2010. Retrieved June 12, 2016, from http://www.census.gov/prod/cen2010/briefs/c2010br-09.pdf United States Department of Health and Human Services. (2014). 2014 actuarial report on the financial outlook for Medicaid. Retrieved June 12, 2016, from http://www.medicaid.gov/medicaid-chip-programinformation/by-topics/financing-and-reimbursement/downloads/medicaid-actuarial-report-2014.pdf United States Government Accountability Office. (July 29, 2014). MEDICAID: completed and preliminary work indicate that transparency around state financing methods and payments to providers is still needed for oversight. Report GAO-14-817T. Retrieved June 12, 2016, from http://www.gao.gov/ assets/670/665069.pdf Vestal, C. (2012). Medicaid: a year of excruciating decisions. Retrieved May 16, 2016, from http://www. stateline.org/live/prntable/story?contentId=624072 Williams, A., Straker, J. K., & Applebaum, R. (2016). The nursing home five star rating: How does it compare to resident and family views of care? The Gerontologist, 56(2), 234–242. doi:10.1093/geront/ gnu043 PMID:24847846 Wysocki, A., Kane, R. L., Dowd, B., Golberstein, E., Lum, T., & Shippee, T. (2014). Hospitalization of elderly Medicaid long-term care users who transition from nursing homes. Journal of the American Geriatrics Society, 62(1), 71–78. doi:10.1111/jgs.12614 PMID:24383662

844

 Long-Term Care Spending Relevant to U.S. Medicaid Expansion

KEY TERMS AND DEFINITIONS Assisted Living Industry: Community-based centers for persons requiring assistance with activities of daily living and/or personal care. Expansion State: State choosing to expand their Medicaid program services in response to the 2010 Patient Protection and Affordable Care Act (ACA). Family Home Caregiver: An individual who provides nursing care and/ or companionship, assistance for another person, such as parent, spouse, child with a disability or chronically ill. Federal Fiscal Year: October 1 of previous year through September 30th. Home Health and Personal Care: Services provided by Medicaid, including standard home health services, personal care, home and community-based care for the functionally disabled elderly, and services provided under home and community-based services waivers. Medicaid: The second largest U.S. public health insurance program for the impoverished of all age groups, the blind, disabled, and medically needy considered impoverished. Medicaid Enrollees: Persons enrolled in the Medicaid program in a fiscal year. Medicare: The largest U.S. public health insurance program for persons under 65 years of age with a disability, age 65 or older, and all age groups with End-Stage Renal Disease. State Fiscal Year: July 1st of previous year through June 30th for the majority of the 50 states.

This research was previously published in Sustainable Health and Long-Term Care Solutions for an Aging Population edited by Ben Fong, Artie Ng, and Peter Yuen, pages 46-70, copyright year 2018 by Medical Information Science Reference (an imprint of IGI Global).

845

xx

Index

A Accept the Present 255, 261, 276 Access Control 286, 302, 740, 746, 759 Activities of Daily Living (ADLs) 2, 12 Acute Kidney Injury 397-398, 410, 424 Acute Pain 615, 646, 667 Agent 117-118, 286, 318, 560, 563, 636, 690-691, 693-695, 698, 702, 705, 792 Aging 1, 12, 17, 38, 78, 94, 156, 218-221, 223, 230, 359361, 364-365, 367-369, 377, 509-514, 516-517, 519, 521-522, 527, 530-531, 534, 536, 671, 673, 709-710, 729, 803-804, 810, 816, 823, 835-836 AIDS 49, 141-145, 147-157, 303-304, 331-332, 365, 382, 450, 541, 580, 732 Alzheimer’s Disease (AD) 1, 12-14, 16, 18, 41, 59, 77-78, 87, 109, 325, 362, 670, 785, 793-794 Americans with Disabilities Act 309 Angina Pectoris 223, 239 Anonymous Credential 751, 754, 762 Anti-coagulants 169, 172, 185-186, 224, 239 Anti-Oxidants 636, 640 Anti-platelets 185-186 Antiretroviral Therapy 143-144 Anxiety 264, 269, 313, 320, 359, 364-366, 402, 451, 454, 457, 469, 487-488, 490-492, 514-516, 518519, 522, 527-528, 530, 536-537, 557, 561, 572573, 575, 577, 584, 597-598, 602, 604, 644, 646 Apathy 3, 12, 509, 537 Arrhythmia 239 Art Therapy 59-63, 66, 68, 71-74 Assisted Living Industry 845 Assistive Technology 15-16, 39, 46, 51, 302, 379, 382 Atherosclerosis 218-219, 221, 226, 240 Attrition 93, 109 Atypical Facial Pain 614, 616 Augmented Reality (AR) 21, 41 Authentication Code 762  

Autism 249, 254, 304, 319-321, 557, 560 Auto-Immune Disease 634, 640

B baclofen 594-595, 603-604, 614 Balloon Compression 610, 615-616 Belize 250-251, 569 Best Practices 103, 257, 283, 286, 302, 425-426, 435-436, 580 Beta-blockers 185-186, 201 Bipolar Disorder and Substance Use 507 botulinum toxin A 602 Burden 5-7, 16, 18-19, 32, 49, 73, 80, 93-94, 96, 100, 108, 113, 149, 186, 199, 307, 345, 360, 362-364, 366, 368, 445, 448-450, 452-453, 462, 467, 470-471, 477-478, 487, 515, 518, 529, 537, 540, 560, 584, 643-644, 652, 655, 661, 670, 680, 723, 798, 825 Burnout 242, 244, 265

C Capacity Assessment 109 carbamazepine 564, 592-596, 598-600, 602-603, 614 Cardiomyopathy 223, 240 Cardiovascular Disease 184, 186, 199, 202, 218, 221, 229, 361-362, 448, 470, 534, 536, 615 Caregiver Burden 5, 7, 73 Caregivers 2-5, 7, 14, 18-22, 27, 29-31, 35, 37, 39, 5963, 65-66, 68-69, 71-74, 79-87, 93, 157, 242-252, 254, 256, 258, 261, 263, 265, 272, 325, 331-332, 334-336, 338-339, 341-342, 344, 357, 362, 515, 521, 542, 673, 676, 687, 709-718, 720, 729, 731732, 736-738, 741-742, 746-748, 751, 753-755, 757, 759, 762, 822, 845 Caregiving 60, 77-79, 81, 87, 245-250, 252, 265, 729, 731-732, 736

Volume I, pp. X1-424; Volume II, pp. 425-845

Index

Certificate 747, 752, 754-755, 757, 762 Childhood Schizophrenia 557-558, 567 Chinese Medicine 218-220, 224-231, 281, 602, 633 Chronic Condition 218, 221, 669, 685 Chronic Diseases 220, 224, 230, 305, 364, 366, 379381, 383-384, 406, 426-427, 514, 534, 631, 644, 674, 680, 685-686, 688, 690, 692, 785-786, 792, 796-797, 799 Chronic Illness 142, 161-162, 179, 303-305, 309, 321322, 339, 341, 345, 351, 353-354, 357, 360, 362, 366, 427, 455, 516, 530, 539 Chronic kidney disease 397-399, 402, 414, 424-426, 429, 670, 785, 797-798 Chronic Pain 263, 530, 540, 602, 631-633, 640, 643644, 646-650, 655, 661, 667 Chronicity (of an Illness) 447, 467 Classification 168, 201-202, 204-205, 208-209, 213, 398, 400-401, 473, 510, 529, 534, 557, 612, 723, 727, 731, 736 Clinical Decision 199-200, 288, 302, 685, 729, 732, 767-768 clinical decision support 199, 288, 685, 729, 732, 767-768 clinical decision-making 288 Clinical History 169, 612, 720-721, 729-730, 736 Clinical Outcome 424 Clinical Pharmacogenetics Implementation Consortium 186 Clinical Question Answering 736 Codetron 634, 640 Cognition 2-3, 7, 12, 342, 429, 469, 471, 512-513, 813 Cognitive Behaviour Therapy 468, 485 commercial 7, 15, 49, 90-91, 108, 142-143, 336, 378, 383, 406, 737-738, 740, 759, 809, 812 Commitment 147, 151, 289-290, 322, 477, 655, 751, 763, 826 Communications Model 825 Comorbidity 445, 449, 489-490, 507, 515, 528-530, 533-537, 539-540, 544, 554-555, 561, 563, 572 Comorbidity in Mental Illness 507 compensatory strategies 7 Computer Reasoning 720 Connection 43, 45-47, 51, 53, 61, 248, 260, 266, 281, 321, 383, 673, 693, 766, 780, 790, 796 Coping 6, 38-39, 317, 359, 364, 368, 377, 425-428, 430-431, 435-436, 475-478, 494 Coronary Heart Disease 184, 198, 223, 531, 539 Covered Home Health Services 685 CPIC Levels 196 CT-guided 610, 618

D Database 84, 90, 92, 105, 107, 110, 172, 186, 282, 286, 325, 382, 390, 402, 406, 633, 652, 689, 693-696, 702, 712-713, 718, 741, 746-747, 750-752, 754, 786, 789-790, 792 Decision Support Systems 161-162, 168, 178, 288, 691, 729, 732, 768, 770 Deep Learning 720, 736 Degree of Confidence 167 Dementia 1-4, 6, 12, 14, 17-20, 36, 41-47, 49, 51-53, 60, 78-80, 90-96, 99-104, 108-109, 223, 288, 325, 362, 365, 448-449, 454, 514-516, 518-519, 522, 527-530, 536-537, 543-544, 793, 804 Depression 4-5, 44, 47, 60, 81, 315, 328, 335, 338, 359, 362, 365-366, 402, 409, 449-450, 455, 462, 469-470, 476, 485, 487-492, 514-515, 518519, 521-522, 527-531, 536-537, 539-540, 561, 563-564, 567, 569-570, 573-575, 577, 584, 592, 597-598, 604, 646, 670, 677 Diabetes 112-113, 119, 162, 168, 198-202, 218-222, 226, 228, 328-329, 332, 338-341, 343-344, 346, 358-369, 377-381, 383-384, 391-392, 400, 514, 530, 532-534, 536, 539-541, 644, 670-671, 687, 692, 702, 705, 728 Dialysis 397, 399, 402, 406, 409-410, 414-415, 426 Disability 6, 15, 44, 52, 114, 147, 152, 156, 198, 305306, 313, 315, 328, 362, 365, 445-450, 452-453, 455, 462, 467-471, 478, 480, 510, 515-516, 519, 528, 539-540, 542-543, 556, 584, 597, 643, 646, 650, 655, 667, 804, 806-807, 810-811, 823, 828, 831, 836, 845 Discrimination 15, 141, 144-145, 147, 150, 152, 155156, 367, 448, 456, 458, 584, 825 Dutch healthcare professionals 764, 771 Dyad 109 Dyslipidemia 221, 223, 240

E Early Onset Schizophrenia 557, 567 Economic Loss 445, 450, 467 Eicosanoid 635, 640 Elderly 15, 20, 38, 44, 62, 77-79, 218-225, 227-228, 254, 288, 360-362, 364, 366-368, 378, 510, 515-522, 528-531, 533, 536-537, 542-544, 554, 592-594, 596, 615, 671, 675, 688, 700, 709-710, 712-713, 716-718, 737-739, 768, 775, 804, 807-809, 811812, 814, 816, 821, 845 Electrolyte Imbalance 397, 410-411, 413, 415, 424

xxi

Index

Electronic Medical Record 658, 685, 689, 695, 725 Emoji Reactions 349, 357 Emotional Support 339-341, 344, 349-350, 353, 357, 522 Emotions 3, 12, 16, 28, 248, 254, 261-262, 265, 268, 320, 341, 364, 435, 472, 474, 477, 485, 516, 557-558, 560, 716 Empowerment 43, 45-47, 49, 52, 151, 455 Encourage 45, 47, 107, 219, 255-257, 263, 270-271, 276, 461, 481, 579, 671, 690, 698, 770, 807, 812, 827-828, 836 Estimated Glomerular Filtration Rate 397, 424 Expansion State 845 Expenditures 392, 457-458, 804-805, 811, 824, 829, 834, 836 Expressed Emotions 474, 477, 485, 558, 560 Extended Family 5, 37, 42, 305

HIV 141-145, 147-157, 303-304, 331, 340, 365, 450, 487 Holter 198-202, 204, 208-209, 213 home assistance 737-738, 740, 746, 748, 754, 759 Home Health and Personal Care 828, 830-831, 833835, 845 Human-Computer Interaction (HCI) 14-15, 42, 715 Humanistic Outcome 402, 424 Hypercholesterolemia 534 Hypertension 184, 218-219, 221-223, 240, 363, 413, 531, 534, 539-540, 593, 601, 670-671, 785, 798

I

Gather Information 80, 255, 262, 276, 724 Genome 185, 196 Genotype 196 Geriatric Population 528, 554 Glycerol 610, 615-616 GPS Tracking 79, 81, 83 Group Therapy 257, 259, 266, 272, 468, 477, 485

Immunology 325-326 Incarceration 569-570, 580-581, 589 Independence 1-3, 7, 12, 37, 43, 45, 49, 51, 91, 95, 99, 108-109, 147, 154, 315, 320, 330, 346, 362, 509, 533-534, 544, 695, 710, 812 Indirect Risk 414, 424 Individual Therapy 485 Inflammation 115, 117, 126, 129, 412, 601, 612, 632, 634-635, 637, 640-641 Informal Carers 43-44, 47, 91, 109, 808-809 Information and Communication Technologies (ICTs) 15, 20, 98, 153-154, 288, 382-383, 687, 689, 692, 699, 709-710, 731, 739 Information Technology 278, 282, 380, 658, 676, 685, 689, 691 Informational Support 338-341, 350, 352-354, 358 injection 114, 116, 123, 126, 129, 581, 601, 603, 616, 635 innovation adoption 277, 292-293 Instruction in the Home 308, 313 Intangible Treasures (i-Treasures) 42 Interest Groups 823, 826, 828, 831, 834-835 Internet of Things (IoT) 720-721, 729, 732 Intervention Strategies 364, 468, 474-475, 481, 485, 556, 560, 564, 578 Invitation Code 754, 763

H

K

Hash Function 763 Health Reform Policy 825 Health-Disease Process 722, 736 Health-Related Quality of Life 398, 402, 415, 424, 427, 539 Healthy Aging 218-219, 519 Herbal Medicine 218-220, 224, 226-229, 397-399, 402, 410-414

Kidney Disease 332, 361, 397-400, 402, 407, 414-415, 424-429, 670, 785, 797-798 Kidney transplantation 397-399, 401, 409, 414-415 Knowledge Management System 302 Knowledge Representation 161, 163, 178, 720-722, 724, 732, 736 Knowledge Representation and Reasoning 161, 163, 178 Knowledge Translation 280-281, 302

F Facebook 341-343, 345-346, 349-351, 353-354, 357-358 Family Carers 44, 49, 51, 80, 90-101, 103-104, 108 Family Home Caregiver 845 Family Intervention 478, 485, 559 Feature Selection 198-199, 202 Federal Fiscal Year 845 financing and delivery systems 817 Formal Carers 44, 47, 808 Free Radical 412, 636, 640

G

xxii

Index

L

N

lamotrigine 593, 595-596, 604, 614 Least Differentiated Caregiver 731, 736 Life Style 169, 172, 250, 362, 364-368, 377 Lipid Lowering Agents 186 Liposomes 121, 123, 126 Logic Programming 161, 163

Nanoparticles 121-122, 124-125, 127, 129 Natural User Interface (NUI) 20, 42 Neuropathic Pain 595-597, 601, 610, 646, 648, 660, 667 Nightshade Plants 634, 640 Nursing Home 51, 79, 243, 284, 291, 515, 811, 815, 822-824, 826, 828, 830-831, 835-836 Nutraceuticals 240

M Machine Learning 198-199, 202, 209, 723 ManagingLife 642-646, 648-650, 653-654, 656, 658662, 667 Mania 490, 561-563, 567, 573 Mechanism of Action 115, 197, 227, 591, 599, 603, 616 Medicaid 60, 670, 672, 814, 822-836, 845 Medicaid Enrollees 845 Medical Comorbidity 534, 555 Medical Illness 377, 515, 528, 536 Medical Image 785 Medicare 60, 142, 521, 529, 542, 670, 672, 674-678, 821-823, 845 Medication Adherence 410, 413, 480, 488 Medication review 764-766, 768-770, 772-775 Medications 1-2, 4, 7, 184-186, 188, 192, 201, 220, 222, 224, 230, 244, 311, 314, 316, 362, 364, 379, 413, 481, 489, 499, 514, 533, 536, 541-543, 545, 560-561, 563, 579-581, 591-593, 595-596, 599600, 604, 614-615, 621, 632, 648, 651, 657, 660, 671, 769-772, 774 Mental Health 60, 148, 244, 288, 328, 330, 335, 339, 362, 365-366, 368, 445-447, 449-450, 453, 455-458, 462, 467, 470, 472, 474-475, 478, 481, 485-487, 494, 509, 514-515, 518-519, 521-522, 530, 537, 556, 568-569, 574, 579-581, 584, 589, 646, 805 Mental Illness 321, 445-447, 449-450, 452, 458, 462, 468-469, 474, 476, 480, 486-489, 493, 499, 507, 509, 514, 522, 537, 556-557, 568, 571, 580, 583, 589, 785, 799 Microparticles 112, 121-126, 129 Mild Cognitive Impairment (MCI) 2, 12, 42 modern medical model 632 Multiple Chronic Conditions 529, 531, 540, 669-670, 674, 686 Multiple Sclerosis 112-114, 334, 448, 595-596, 613, 616-617, 643 Myocardial Infarction 200, 226, 240

O Old Age Home (OAH) 515, 519, 527, 807 Ontology 390, 693-697, 700, 704-705, 722-724, 726727, 729, 731-732, 736 OTP (one-time password) 787 Outcome 12, 106, 144, 169, 197, 202, 219, 226, 257, 259, 302, 311, 398-400, 402, 406-407, 409, 414-415, 424, 427, 429, 470, 473-475, 477, 488, 491, 556-557, 559, 561, 563-564, 570, 618, 637, 654-655, 659, 672, 812-813, 830 oxcarbazepine 592-596, 603, 614

P Pain 115, 147, 149, 225, 228, 239, 257, 260-263, 366, 402, 409, 476, 530-531, 540, 591-603, 610-618, 620-622, 632-637, 640-643, 645-657, 659-662, 667, 805 pain management 540, 631-634, 637, 642-643, 645646, 650, 652, 659 Pathophysiological Pathways 533, 535, 555 Patient Involvement 430 patient monitoring 679, 740 Patient Protection and Affordable Care Act 821-823, 828, 836, 845 Pediatric Bipolar Disorder 561, 563-564, 567 Pharmacodynamics 187, 197 Pharmacogenetics 185-187, 192, 197 Pharmacogenomics 184-186, 192, 197 Pharmacokinetics 121, 187, 197, 536, 593, 597, 599 PharmaGKB Level of Evidence 197 Phenotype 127-128, 185, 197, 561 Polymers 122-123 Polymorphic 197 Polypharmacy 222, 225, 621, 764-766, 768-771 Positive Psychology 377 Practice Patience 255, 260, 269, 276 Prevention of Parent to Child Transmission 144

xxiii

Index

Prison 456, 480, 568-572, 574-577, 579-581, 584, 589 Prisoners 568-575, 577, 581, 584, 589 privacy 51, 81, 148, 286-287, 405, 569, 658, 694-695, 737-740, 744, 747, 751-752, 754, 757-758 Prognostic Tool 199 Progression of Chronic Kidney Disease 424 Proteinuria 397, 399-401, 424 Psychiatric Comorbidity 536, 555 Public Cloud 688, 694-696 Public Key Cryptography 763 Pygnogenol 636, 640

Q Qi 220, 228, 602, 633, 641 quality healthcare 281 Quality of life 2, 5, 14-16, 30, 39, 43-47, 49, 51, 53, 77, 80-81, 87, 93-95, 108, 112, 119, 128-129, 219, 225-226, 249, 280, 288, 329, 360-362, 365-366, 397-398, 402, 415, 424, 427, 471, 475, 485, 519, 522, 528-529, 531, 536, 539-540, 580, 597, 644, 655-657, 672-674, 677, 686, 732, 809 Questionnaire 93, 98-99, 293, 402, 406, 409-410, 413414, 531, 572, 651, 768, 806

R Radiofrequency Ablation 617 Red Ribbon Express 156-157 Rehabilitation 16, 38, 244, 257-258, 288, 309, 315, 317, 336, 454-455, 458-459, 467-468, 470, 474, 478, 480, 499, 519, 522, 543, 568, 570, 739, 813 Remote Monitoring 669, 671-673, 675-680, 686-687, 690, 700, 705 Renal Adverse Effect 424 Respite 242-245, 247, 249-250, 252, 254 Respite Tourism 242-243, 247, 250, 252, 254 Retweet 346, 349-350, 358 Rheumatoid Arthritis 112-113, 115, 318, 634, 636, 785, 797 role of food 632

S safety 6-7, 45, 49, 51, 78-82, 87, 91, 96, 99, 102, 109, 114-116, 129, 228-230, 288, 304, 312, 329, 397, 413, 561-562, 565, 580, 593, 603, 709, 711, 718, 768-769 Schizophrenia 335, 447-449, 452, 454-456, 462, 468477, 479-481, 485-486, 488-491, 507, 556-560, 567, 573, 575 xxiv

Schizophrenia and Substance Use 507 Section 504 309, 315 Self-Care 255, 264-265, 271-273, 276, 341, 365-367, 427, 654, 672, 686, 804 Self-Efficacy 4, 7, 13, 446 Serious Games 14, 42 Service Oriented Architecture (SOA) 787, 789-790 Sexually Transmitted Disease 149 Sexually Transmitted Infection 143 side effects 114, 218, 223-226, 228, 314, 345, 409-410, 481, 533, 543, 560, 563-564, 580, 591-603, 615, 618, 620-621, 632, 651, 654, 657, 767, 771, 774 Social Support 47, 151, 156, 338-344, 346, 350-354, 357-358, 367, 407, 494 State Fiscal Year 825, 845 Stigmatization and Denial 144 Stress 5, 7, 34, 45, 47, 51, 80, 96, 100, 141, 144, 242, 244, 246, 248, 252, 254, 260-261, 264-266, 268, 276, 313, 321, 365-368, 402, 447, 449, 459, 467, 472, 474, 477-478, 481, 514, 569, 575, 577, 688, 798, 809, 824 Substance Use Disorder (SUD) 469, 488-489, 499, 507-508, 527, 537 Substance Use Disorder in Mentally Ill in India 508 Supply and demand 817, 822 surgery 69, 162, 227, 243, 255-256, 258, 261-262, 264, 271, 314-315, 319, 327, 329, 598, 615, 642-643, 645-646, 648, 652, 654, 657-661 Symmetric Key Cryptography 763

T Technology 7, 14-17, 20, 36, 39, 45-47, 49, 51, 53, 79, 81, 97-98, 104, 108, 117, 122, 125-126, 150, 153, 250, 256, 267-268, 277-279, 282, 287-290, 293, 302, 340-341, 378-380, 382-383, 392, 521, 631, 633, 637, 648, 658, 672, 676-677, 685-687, 689-694, 701, 710, 712-713, 724, 729, 738, 740, 765, 786, 789-790 Telecare 46, 51, 90-93, 95, 97, 99-110, 692, 739 Telehealth 92, 288, 672-677, 686, 689, 692, 699 Telehomecare 669, 671-674, 679-680, 686-689, 691693, 698, 700, 704-705 Telemedicine 51, 380, 679, 686-687, 689, 691-692, 700 Thrombophilia 161-162, 169-170, 172-173, 175-179 TOE framework 278, 287, 292-293 Toronto General Hospital (TGH) 642, 644, 646, 652, 655, 658-659, 661, 667 Tourism Observatory for Health 252 traditional Chinese medicine 218, 220, 602, 633 traditional medicine 225

Index

Transition 39, 147, 157, 321, 425-426, 428-431, 435436, 510, 522, 560, 614, 642, 673, 678, 830 Transitional Pain Service (TPS) 642, 644, 646, 648, 659-660, 662, 667 Triangulation 92, 109 Trusted Platform Module 754, 763 Tweet 358 Twitter 341-346, 349-354, 358 Type 1 Diabetes (T1D) 112, 119, 228, 338-339, 358, 360, 367, 379, 391-392

U Ultrasound-guided 619 University Health Network (UHN) 667 Urolithiasis 228, 397-398, 402, 413-415

Verifiable Encryption 763 Visual Communication 59, 61-62, 73-74

W Web Portal 90, 92-93, 99-102, 104-108, 110, 340 Wireless Body Area Network 736

X Xanthones 636-637, 641

Y Young People 425-431, 435-436, 453, 455, 516, 518, 560

V V2 branch 610 Venous Thromboembolism 161-162, 224

xxv