Advances in Human Factors and Ergonomics in Healthcare and Medical Devices : Proceedings of the AHFE 2017 International Conferences on Human Factors and Ergonomics in Healthcare and Medical Devices, July 17-21, 2017, The Westin Bonaventure Hotel, Los Angeles, California, USA 978-3-319-60483-1, 331960483X, 978-3-319-60482-4

Table of contents :
Front Matter....Pages i-xv
Front Matter....Pages 1-1
Increasing Patient Safety Through Resilient Design: Using Human Factors Engineering and Environmental Support Mechanisms to Reduce Potentials of Hospital Acquired Infection....Pages 3-10
An Ergonomic Evaluation of Preoperative and Postoperative Workspaces in Ambulatory Surgery Centers....Pages 11-21
Characteristics of United States Military Personnel and Veterans Who Complete Mindfulness Training....Pages 22-32
Evidence of a Symptom Cluster: The Impact of Mindfulness Meditation on Self-Reported Stress, Fatigue, Pain and Sleep Among U.S. Military Service Members and Veterans....Pages 33-44
Evaluation of Effect on Cognition Response to Time Pressure by Using EEG....Pages 45-52
A Pilot Study Evaluating the Utility, Acceptability, and Feasibility of an Abbreviated Mindfulness Meditation Program Before and During Army Warfighting Training....Pages 53-63
Front Matter....Pages 65-65
Learning Effects of Perturbation to Postural Control in Diabetics with Neuropathy....Pages 67-72
Considering Ergonomics in the Accident and Emergency Department: Possible or Not....Pages 73-79
Superficial Electromyography, Motion Analysis and Triggered-Stereo Cameras Technologies Applied to Ultrasound System User Interface Evaluation....Pages 80-89
Case Study of Integrated Ergonomic Assessment of a Cart-Based High-End Ultrasound System....Pages 90-99
Development of a Support System for the Presumptive Diagnosis of Glaucoma Through the Processing of Biomedical Images of the Human Eye Fundus in Ecuador....Pages 100-109
A RGB-D Sensor Based Tool for Assessment and Rating of Movement Disorders....Pages 110-118
A Comprehensive Approach for Physical Rehabilitation Assessment in Multiple Sclerosis Patients Based on Gait Analysis....Pages 119-128
HomeAssist: An Assisted Living Platform for Aging in Place Based on an Interdisciplinary Approach....Pages 129-140
Healthcare Application for Foreigners Living in China....Pages 141-148
Train4OrthoMIS Online Course as a Manner of Improving Ergonomics in Orthopaedic Surgery....Pages 149-158
Quality Care and Patient Safety: Strategies to Disclose Medical Errors....Pages 159-167
Front Matter....Pages 169-169
Effect of Walking upon Fatigue Due to Monotonous Work....Pages 171-179
Modeling Self-determination in Emotional Labor: Stressful Patient Interactions, Emotion Regulation, and Burnout in Geriatric Nursing....Pages 180-192
Assessment of Postural Analysis in a Dialysis Clinic....Pages 193-204
Front Matter....Pages 169-169
Most Effective Exercise Load for Burning Body Fat with Aerobic Exercise in Young Japanese Women....Pages 205-215
Gender Difference and Optimal Carrying Load Limit for Industrial Workers....Pages 216-228
Influence of the Traditional Use of Chumbi in Lumbar Weakness in Women of Ecuadorian Highlands....Pages 229-238
Analysis of Risk for Repetitive Work Using Thermography Sensory....Pages 239-248
Front Matter....Pages 249-249
Taxonomy of Communications in the Operating Room....Pages 251-262
A Proactive Risk Assessment Framework to Enhance Patient Safety in Operating Rooms....Pages 263-274
Lessons Learned from the Implementation of a Specialized Health Care Network in the Municipality of Porto Alegre, Brazil....Pages 275-286
Effectiveness and User Satisfaction from a Usability Evaluation of a Veterans Benefits Letter....Pages 287-296
Research on the Development of the Maternity Dress Based on the Health and Safety....Pages 297-302
Movement Analysis and Ergonomic Garment Opening Design of Garment Block Patterns for Physically Disabled People with Scoliosis Using Fuzzy Logic....Pages 303-314
Modeling of Electronic and Mechanical Dimensioning of an Exoskeleton Bottom for Bipedal Gait....Pages 315-323
Adhesion Distribution Between a Hygiene Mask and a Female Dummy Face via Multiple Approaches....Pages 324-330
Qualitative, Quantitative or Mixed: Which Is the Most Preferred for Healthcare Studies....Pages 331-336
Service Based Healthcare Monitoring System for the Elderly - Physical Activity and Exercise....Pages 337-342
Reorganizing Neonatal Resuscitation Equipment Improves Performance Speed Under Simulation Conditions....Pages 343-351
Bridging the Gap Between Human Factors and Epidemiological Models: Recommendations for Future Research....Pages 352-363
Development of Stroke Diagnosis Algorithm Through Logistic Regression Analysis with National Health Insurance Database....Pages 364-366
Evaluation of Ergonomic Risk Factors and Presence of Musculoskeletal Symptoms in Medical Specialty in Echography....Pages 367-377
Relationship Between Ergonomic Workstations with Musculoskeletal Disorders and Job Stress Among Staff of Bank in Tehran City....Pages 378-387
Higher Functioning Teams Improve the Triage Process in Las Cruces, NM....Pages 388-394
Front Matter....Pages 395-395
Medical Tourism, Biomedical Wastes and Health Hazard....Pages 397-405
DesignX in the Emergency Department: Requirements of a Digital Antibiogram....Pages 406-414
Operational Efficiency Analysis of Public Hospital Systems of India: Application of Data Envelopment Analysis....Pages 415-424
Front Matter....Pages 425-425
Ergonomic Assessment and Analysis of Postural Load of Surgeons Performing Laparoscopic Surgeries in Cuenca, Ecuador....Pages 427-437
Further Development and Evaluation of a Universal Foot Switch for Diverse Medical Disciplines within the Framework of an Open Integration Concept for the Operation Theatre of the Future....Pages 438-449
Effects of Noises and Music on Nurses’ Mental Workload and Situation Awareness in the Operating Room....Pages 450-454
Preliminary Study of Ontological Process Analysis of Surgical Endoscopy....Pages 455-461
Operating Room Ergonomics: A Practical Approach for Reducing Operating Room Ergonomic Hazards....Pages 462-468
Incorrect Surgery and Invasive Procedures: Internet Videos Fail to Depict the Full Story....Pages 469-476
Front Matter....Pages 477-477
Teaching Proactive Risk Assessment to Clinicians and Administrators....Pages 479-487
Potential and Influence of Industrie 4.0 in Oral Implantology Products and Their Production for Patient, Dentist and Dental Laboratory....Pages 488-498
Development of Pneumatic Dual-Cell Stacking Implanter....Pages 499-507
Human Factors in Prosthesis of Total Knee Arthroplasty....Pages 508-518
Mathematical Modeling and Ergonomic Study of a Pencil Through Numerical Simulation for Support of the Graphological Presumptive Diagnosis....Pages 519-528
Precise Placement of Precordial Electrodes with +/−0.5 cm Accuracy for Recording ECG in Self-operable Diagnostic Devices....Pages 529-539
A Domotics Control Tool Based on MYO Devices and Neural Networks....Pages 540-548
Biomimetical Arm Prosthesis: A New Proposal....Pages 549-558
Design of an Intelligent System for Prediction and Simulation of Writing in Children with Spasticity....Pages 559-568
Privacy and Security of Cardiovascular Implantable Electronic Devices: Applying a Contextual Integrity Analysis....Pages 569-580
Method of Ergonomics Assessment of Technical Systems and Its Influence on Operators Heath on Basis of Hybrid Fuzzy Models....Pages 581-592
Front Matter....Pages 477-477
Hazard and Safety Analysis of the Integra™ UltraVS™ Neonate Valve....Pages 593-599
Investigation of Human Factors Engineering Methods Used in Medical Device Procurement Process....Pages 600-608
Usefulness of Skin Punch Tools for Corneal Biopsy....Pages 609-617
Medical Device Design for Improving Orthostatic Hypotension During Supine-to-Stand (STS)....Pages 618-630
Back Matter....Pages 631-633

Citation preview

Advances in Intelligent Systems and Computing 590

Vincent Duffy Nancy Lightner Editors

Advances in Human Factors and Ergonomics in Healthcare and Medical Devices Proceedings of the AHFE 2017 International Conferences on Human Factors and Ergonomics in Healthcare and Medical Devices, July 17–21, 2017, The Westin Bonaventure Hotel, Los Angeles, California, USA

Advances in Intelligent Systems and Computing Volume 590

Series editor Janusz Kacprzyk, Polish Academy of Sciences, Warsaw, Poland e-mail: [email protected]

About this Series The series “Advances in Intelligent Systems and Computing” contains publications on theory, applications, and design methods of Intelligent Systems and Intelligent Computing. Virtually all disciplines such as engineering, natural sciences, computer and information science, ICT, economics, business, e-commerce, environment, healthcare, life science are covered. The list of topics spans all the areas of modern intelligent systems and computing. The publications within “Advances in Intelligent Systems and Computing” are primarily textbooks and proceedings of important conferences, symposia and congresses. They cover significant recent developments in the field, both of a foundational and applicable character. An important characteristic feature of the series is the short publication time and world-wide distribution. This permits a rapid and broad dissemination of research results.

Advisory Board Chairman Nikhil R. Pal, Indian Statistical Institute, Kolkata, India e-mail: [email protected] Members Rafael Bello Perez, Universidad Central “Marta Abreu” de Las Villas, Santa Clara, Cuba e-mail: [email protected] Emilio S. Corchado, University of Salamanca, Salamanca, Spain e-mail: [email protected] Hani Hagras, University of Essex, Colchester, UK e-mail: [email protected] László T. Kóczy, Széchenyi István University, Győr, Hungary e-mail: [email protected] Vladik Kreinovich, University of Texas at El Paso, El Paso, USA e-mail: [email protected] Chin-Teng Lin, National Chiao Tung University, Hsinchu, Taiwan e-mail: [email protected] Jie Lu, University of Technology, Sydney, Australia e-mail: [email protected] Patricia Melin, Tijuana Institute of Technology, Tijuana, Mexico e-mail: [email protected] Nadia Nedjah, State University of Rio de Janeiro, Rio de Janeiro, Brazil e-mail: [email protected] Ngoc Thanh Nguyen, Wroclaw University of Technology, Wroclaw, Poland e-mail: [email protected] Jun Wang, The Chinese University of Hong Kong, Shatin, Hong Kong e-mail: [email protected]

More information about this series at http://www.springer.com/series/11156

Vincent Duffy Nancy Lightner •

Editors

Advances in Human Factors and Ergonomics in Healthcare and Medical Devices Proceedings of the AHFE 2017 International Conferences on Human Factors and Ergonomics in Healthcare and Medical Devices, July 17–21, 2017, The Westin Bonaventure Hotel, Los Angeles, California, USA

123

Editors Vincent Duffy School of Industrial Engineering Purdue University West Lafayette, IN USA

Nancy Lightner Center for Applied Systems Engineering Veterans Affairs Indianapolis, IN USA

ISSN 2194-5357 ISSN 2194-5365 (electronic) Advances in Intelligent Systems and Computing ISBN 978-3-319-60482-4 ISBN 978-3-319-60483-1 (eBook) DOI 10.1007/978-3-319-60483-1 Library of Congress Control Number: 2017943028 © Springer International Publishing AG 2018 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Printed on acid-free paper This Springer imprint is published by Springer Nature The registered company is Springer International Publishing AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland

Advances in Human Factors and Ergonomics 2017

AHFE 2017 Series Editors Tareq Z. Ahram, Florida, USA Waldemar Karwowski, Florida, USA

8th International Conference on Applied Human Factors and Ergonomics and the Affiliated Conferences Proceedings of the AHFE 2017 International Conferences on Human Factors and Ergonomics in Healthcare and Medical Devices, July 17–21, 2017, The Westin Bonaventure Hotel, Los Angeles, California, USA Advances in Affective and Pleasurable Design Advances in Neuroergonomics and Cognitive Engineering Advances in Design for Inclusion Advances in Ergonomics in Design Advances in Human Error, Reliability, Resilience, and Performance Advances in Human Factors and Ergonomics in Healthcare and Medical Devices Advances in Human Factors in Simulation and Modeling Advances in Human Factors and System Interactions Advances in Human Factors in Cybersecurity Advances in Human Factors, Business Management and Leadership Advances in Human Factors in Robots and Unmanned Systems Advances in Human Factors in Training, Education, and Learning Sciences Advances in Human Aspects of Transportation

WonJoon Chung and Cliff (Sungsoo) Shin Carryl Baldwin Giuseppe Di Bucchianico and Pete Kercher Francisco Rebelo and Marcelo Soares Ronald L. Boring Vincent G. Duffy and Nancy Lightner Daniel N. Cassenti Isabel L. Nunes Denise Nicholson Jussi Kantola, Tibor Barath and Salman Nazir Jessie Chen Terence Andre Neville A. Stanton (continued)

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Advances in Human Factors and Ergonomics 2017

(continued) Advances in Human Factors, Software, and Systems Engineering Advances in Human Factors in Energy: Oil, Gas, Nuclear and Electric Power Industries Advances in Human Factors, Sustainable Urban Planning and Infrastructure Advances in the Human Side of Service Engineering Advances in Physical Ergonomics and Human Factors Advances in Human Factors in Sports, Injury Prevention and Outdoor Recreation Advances in Safety Management and Human Factors Advances in Social & Occupational Ergonomics Advances in Ergonomics of Manufacturing: Managing the Enterprise of the Future Advances in Usability and User Experience Advances in Human Factors in Wearable Technologies and Game Design Advances in Communication of Design Advances in Cross-Cultural Decision Making

Tareq Z. Ahram and Waldemar Karwowski Paul Fechtelkotter and Michael Legatt Jerzy Charytonowicz Louis E. Freund and Wojciech Cellary Ravindra Goonetilleke and Waldemar Karwowski Tareq Z. Ahram Pedro Arezes Richard Goossens Stefan Trzcielinski Tareq Ahram and Christianne Falcão Tareq Ahram and Christianne Falcão Amic G. Ho Mark Hoffman

Preface

This book is concerned with human factors and ergonomics in health care and medical devices. The utility of this area of research is to aid the design of systems and devices for effective and safe healthcare delivery. New approaches are demonstrated for improving healthcare devices such as portable ultrasound systems. Research findings for improved work design, effective communications, and systems support are also included. Healthcare informatics for the public and usability for patient users are considered separately but build on results from usability studies for medical personnel. Quality and safety are emphasized, and medical error is considered for risk factors and information transfer in error reduction. Physical, cognitive, and organizational aspects are considered in a more integrated manner so as to facilitate a systems approach to implementation. New approaches to patient handling ergonomics, emergency and operating rooms, health care, medical device design, human factors and ergonomics measurement and model validation are included. Recent research on special populations, collaboration, and teams, as well as learning and training, allows practitioners to gain a great deal of knowledge overall from this book. Explicitly, this book is organized into seven sections that contain the following subject areas: I. II. III. IV. V. VI. VII.

Healthcare Environment Patient Care Tools Employee Health Human Factors in Healthcare Healthcare Systems Design Human Factors in Medical and Surgical Settings Human Factors in Medical Devices Design

Each of the chapters of this book was either reviewed by the members of Scientific Advisory and Editorial Board or germinated by them. Our sincere thanks and appreciation go to the Board members listed below for their contribution to the high scientific standard maintained in developing this book. vii

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Preface

Patricia Arnold, Germany Tommaso Bellandi, Italy Balmatee Bidassie, USA Sue Bogner, USA Fehti Calisir, Turkey Yoel Donchin, Israel Achim Elfering, Switzerland Mahmut Eksioglu, Turkey Enda Fallon, Ireland Mike Fray, UK Anand Gramopadhye, USA Sue Hignett, UK Erik Hollnagel, France Jay Kalra, Canada Sharon Kleefield, USA Basia Kutryba, Poland Bruce Byung Cheol Lee, USA Nicolas Marmaras, Greece Jennifer L. Martin, UK Rosângela Míriam Mendonca, Brazil Kathy Norris, USA Michiko Ohkura, Japan Calvin Or, Hong Kong Lenore Page, USA Stavros Prineas, Australia Paolo Trucco, Italy Xin Feng, USA This book would be of special value internationally to those researchers and practitioners involved in various aspects of healthcare delivery. July 2017

Vincent G. Duffy Nancy Lightner

Contents

Human Factors in the Healthcare Environment Increasing Patient Safety Through Resilient Design: Using Human Factors Engineering and Environmental Support Mechanisms to Reduce Potentials of Hospital Acquired Infection . . . . . . . . . . . . . . . . Lisa Sundahl Platt and Michael Greene

3

An Ergonomic Evaluation of Preoperative and Postoperative Workspaces in Ambulatory Surgery Centers . . . . . . . . . . . . . . . . . . . . . . Deborah Wingler, Anjali Joseph, and Rutali Joshi

11

Characteristics of United States Military Personnel and Veterans Who Complete Mindfulness Training . . . . . . . . . . . . . . . . . . . . . . . . . . . . Baoxia Liu and Valerie J. Rice

22

Evidence of a Symptom Cluster: The Impact of Mindfulness Meditation on Self-Reported Stress, Fatigue, Pain and Sleep Among U.S. Military Service Members and Veterans . . . . . . . . . . . . . . . Valerie J. Rice and Paul J. Schroeder

33

Evaluation of Effect on Cognition Response to Time Pressure by Using EEG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Shyh-Yueh Cheng

45

A Pilot Study Evaluating the Utility, Acceptability, and Feasibility of an Abbreviated Mindfulness Meditation Program Before and During Army Warfighting Training . . . . . . . . . . . . . . . . . . . . . . . . . . Valerie J. Rice, Gary L. Boykin, Cory R. Overby, Angela Jeter, and Jessica Villarreal

53

ix

x

Contents

Human Factors in Patient Care Tools Learning Effects of Perturbation to Postural Control in Diabetics with Neuropathy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Byungjoon B.J. Kim and Tracey Kim

67

Considering Ergonomics in the Accident and Emergency Department: Possible or Not . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Ahmad Rasdan Ismail, Shaik Farid Abdull Wahab, and Rohayu Othman

73

Superficial Electromyography, Motion Analysis and Triggered-Stereo Cameras Technologies Applied to Ultrasound System User Interface Evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Federica Vannetti, Tiziana Atzori, Laura Fabbri, Guido Pasquini, Leonardo Forzoni, and Claudio Macchi

80

Case Study of Integrated Ergonomic Assessment of a Cart-Based High-End Ultrasound System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Giuseppe Andreoni, Alfredo Goddi, Luca Aiani, Nicola Gaibazzi, Zhan Weiwei, Fabio Rezzonico, Nicola Guraschi, Marco Delpiano, Claudio Fertino, Deanna Garcia, Luis Rojas, and Leonardo Forzoni

90

Development of a Support System for the Presumptive Diagnosis of Glaucoma Through the Processing of Biomedical Images of the Human Eye Fundus in Ecuador . . . . . . . . . . . . . . . . . . . . . . . . . . . 100 Eduardo Pinos-Vélez, Susana Encalada, Edwin Gamboa, Vladimir Robles-Bykbaev, William Ipanque, and Carlos Luis Chacón A RGB-D Sensor Based Tool for Assessment and Rating of Movement Disorders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 Vitoantonio Bevilacqua, Gianpaolo Francesco Trotta, Claudio Loconsole, Antonio Brunetti, Nicholas Caporusso, Giuseppe Maria Bellantuono, Irio De Feudis, Donato Patruno, Domenico De Marco, Andrea Venneri, Maria Grazia Di Vietro, Giacomo Losavio, and Sabina Ilaria Tatò A Comprehensive Approach for Physical Rehabilitation Assessment in Multiple Sclerosis Patients Based on Gait Analysis . . . . . . . . . . . . . . . 119 Vitoantonio Bevilacqua, Gianpaolo Francesco Trotta, Antonio Brunetti, Nicholas Caporusso, Claudio Loconsole, Giacomo Donato Cascarano, Francesco Catino, Pantaleo Cozzoli, Giancarlo Delfine, Adriano Mastronardi, Andrea Di Candia, Giuseppina Lelli, and Pietro Fiore HomeAssist: An Assisted Living Platform for Aging in Place Based on an Interdisciplinary Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 129 Charles Consel, Lucile Dupuy, and Hélène Sauzéon Healthcare Application for Foreigners Living in China . . . . . . . . . . . . . . 141 Syed Attiqur Rehman, Zhe Chen, and Muhammad Haris

Contents

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Train4OrthoMIS Online Course as a Manner of Improving Ergonomics in Orthopaedic Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149 Joanna Bartnicka, Alicia Piedrabuena, Raquel Portilla, Juan Luis Moyano-Cuevas, José Blas Pagador, Francisco M. Sánchez-Margallo, Peter Augat, Dariusz Michalak, and Jarosław Tokarczyk Quality Care and Patient Safety: Strategies to Disclose Medical Errors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 159 Jawahar (Jay) Kalra and Ashish Kopargaonkar Human Factors and Employee Health Effect of Walking upon Fatigue Due to Monotonous Work . . . . . . . . . . . 171 Kousuke Aramaki and Hiroshi Hagiwara Modeling Self-determination in Emotional Labor: Stressful Patient Interactions, Emotion Regulation, and Burnout in Geriatric Nursing . . . . 180 Severin Hornung, Bettina Lampert, Matthias Weigl, and Jürgen Glaser Assessment of Postural Analysis in a Dialysis Clinic . . . . . . . . . . . . . . . . 193 Kira Andrea C. Chan, John A. Molina, and Denise Ann T. Tirthdas Most Effective Exercise Load for Burning Body Fat with Aerobic Exercise in Young Japanese Women . . . . . . . . . . . . . . . . . . 205 Tamaki Mitsuno, Miya Nagayasu, Yuko Shinohara, and Yui Ando Gender Difference and Optimal Carrying Load Limit for Industrial Workers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 216 Rohit Sharma, Kushal Kamboj, Purshottam Kumar, and Jyoti Bhardwaj Influence of the Traditional Use of Chumbi in Lumbar Weakness in Women of Ecuadorian Highlands . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229 Thalía San Antonio, Anita Larrea, Fernando Urrutia, María Naranjo, and María Latta Analysis of Risk for Repetitive Work Using Thermography Sensory . . . . . . 239 Alejandra García, Claudia Camargo, Jesús Olguín, and J. Andrés López Barreras Human Factors in Healthcare Taxonomy of Communications in the Operating Room . . . . . . . . . . . . . . 251 Carlos A. Velasquez, Rashid Mazhar, Amer Chaikhouni, Tian Zhou, and Juan P. Wachs A Proactive Risk Assessment Framework to Enhance Patient Safety in Operating Rooms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263 Maryam Tabibzadeh and Gelareh Jahangiri

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Contents

Lessons Learned from the Implementation of a Specialized Health Care Network in the Municipality of Porto Alegre, Brazil . . . . . . . . . . . 275 Anna Luiza Bueno Coutinho and Werner Leyh Effectiveness and User Satisfaction from a Usability Evaluation of a Veterans Benefits Letter . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 287 Nancy J. Lightner, Helen J.A. Fuller, Kyle D. Maddox, Nsikak E. Inyang, and Dennis Lofton Research on the Development of the Maternity Dress Based on the Health and Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297 Shang Yuting Movement Analysis and Ergonomic Garment Opening Design of Garment Block Patterns for Physically Disabled People with Scoliosis Using Fuzzy Logic . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 303 Yan Hong, Xianyi Zeng, Pascal Bruniaux, Antonela Curteza, and Yan Chen Modeling of Electronic and Mechanical Dimensioning of an Exoskeleton Bottom for Bipedal Gait. . . . . . . . . . . . . . . . . . . . . . . . 315 Serpa-Andrade Luis, Illescas Francisco, Cuzco William, and Pinos-Velez Eduardo Adhesion Distribution Between a Hygiene Mask and a Female Dummy Face via Multiple Approaches . . . . . . . . . . . . . . . . . . . . . . . . . . . 324 Mika Morishima and Tamaki Mitsuno Qualitative, Quantitative or Mixed: Which Is the Most Preferred for Healthcare Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 331 Shaik Farid Abdull Wahab, Ahmad Rasdan Ismail, and Rohayu Othman Service Based Healthcare Monitoring System for the Elderly - Physical Activity and Exercise . . . . . . . . . . . . . . . . . . . . 337 Se Jin Park, Murali Subramaniyam, Seunghee Hong, and Damee Kim Reorganizing Neonatal Resuscitation Equipment Improves Performance Speed Under Simulation Conditions . . . . . . . . . . . . . . . . . . 343 Brenda Law, Po-Yin Cheung, Megan O’Reilly, Caroline Fray, and Georg Schmölzer Bridging the Gap Between Human Factors and Epidemiological Models: Recommendations for Future Research . . . . . . . . . . . . . . . . . . . 352 Anna Paula Galvão Scheidegger and Amarnath Banerjee Development of Stroke Diagnosis Algorithm Through Logistic Regression Analysis with National Health Insurance Database . . . . . . . . 364 Seung Nam Min, Kyung-Sun Lee, Se Jin Park, Murali Subramaniyam, and Dong Joon Kim

Contents

xiii

Evaluation of Ergonomic Risk Factors and Presence of Musculoskeletal Symptoms in Medical Specialty in Echography . . . . . . . 367 Elena Ochoa-Chaidez, Elvia L. Gonzalez-Muñoz, Enrique Herrera-Lugo, and Jean-Paul Becker Relationship Between Ergonomic Workstations with Musculoskeletal Disorders and Job Stress Among Staff of Bank in Tehran City . . . . . . . 378 Tabatabaei Yahyaabadi Shahnaz, Khani Jazani Reza, Kavousi Amir, and Bahreini Maryam Higher Functioning Teams Improve the Triage Process in Las Cruces, NM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 388 Lori DeLeeuw, Nancy Hallbauer, Chris Baeza, Deborah E. Welsh, Gary Sculli, and Crystal Davis-Whited Healthcare Systems Design Medical Tourism, Biomedical Wastes and Health Hazard . . . . . . . . . . . . 397 Bela Das DesignX in the Emergency Department: Requirements of a Digital Antibiogram . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 406 Isaac Fehr, Lars Mueller, and Eliah Aronoff-Spencer Operational Efficiency Analysis of Public Hospital Systems of India: Application of Data Envelopment Analysis . . . . . . . . . . . . . . . . . . . . . . . . 415 Abhik Patra and Pradip Kumar Ray Human Factors in Medical and Surgical Settings Ergonomic Assessment and Analysis of Postural Load of Surgeons Performing Laparoscopic Surgeries in Cuenca, Ecuador . . . . . . . . . . . . . 427 Mónica Ordóñez-Ríos, Oswaldo Jara-Díaz, Juan C. Salamea, and Vladimir Robles-Bykbaev Further Development and Evaluation of a Universal Foot Switch for Diverse Medical Disciplines within the Framework of an Open Integration Concept for the Operation Theatre of the Future . . . . . . . . . 438 Anna Vitting, Armin Janß, Benjamin Strathen, Melanie Strake, and Klaus Radermacher Effects of Noises and Music on Nurses’ Mental Workload and Situation Awareness in the Operating Room . . . . . . . . . . . . . . . . . . . 450 Li-Ping Tseng and Yung-Ching Liu Preliminary Study of Ontological Process Analysis of Surgical Endoscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 455 Kazuhiko Shinohara

xiv

Contents

Operating Room Ergonomics: A Practical Approach for Reducing Operating Room Ergonomic Hazards . . . . . . . . . . . . . . . . . . . . . . . . . . . . 462 Yona Vaisbuc, Justin M. Moore, Robert K. Jackler, and John Vaughan Incorrect Surgery and Invasive Procedures: Internet Videos Fail to Depict the Full Story . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 469 Douglas E. Paull, Robert Kononowech, Sarah Simpson, David M. Sine, and Robin R. Hemphill Human Factors in Medical Devices Design Teaching Proactive Risk Assessment to Clinicians and Administrators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 479 Tandi Bagian and Helen J.A. Fuller Potential and Influence of Industrie 4.0 in Oral Implantology Products and Their Production for Patient, Dentist and Dental Laboratory . . . . . 488 Yübo Wang, Oliver Sandig, Christian Steinmetz, Christof Ellerbrock, and Reiner Anderl Development of Pneumatic Dual-Cell Stacking Implanter . . . . . . . . . . . . 499 Yih-Lin Cheng and Yi-Tung Lai Human Factors in Prosthesis of Total Knee Arthroplasty . . . . . . . . . . . . 508 Rene Pimentel, Cristiano Fontes, Salvador Àvila, Jocelma Rios, Adonias Magdiel, Cristiane Fragoso, Ivone Cerqueira, and Caroline Massolino Mathematical Modeling and Ergonomic Study of a Pencil Through Numerical Simulation for Support of the Graphological Presumptive Diagnosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . 519 Luis González-Delgado, Julio Verdugo-Cabrera, Luis Serpa-Andrade, Isaac Ojeda-Zamalloa, Vladimir Robles-Bykbaev, Fernando Pesántez-Avilés, Olena Naidiuk, and Ninfa González-Delgado Precise Placement of Precordial Electrodes with +/−0.5 cm Accuracy for Recording ECG in Self-operable Diagnostic Devices . . . . . . . . . . . . . 529 Kavita Shashank, Sakire Arslan Ay, Ankit Fulzele, R.C. Ram, Huan Hu, and Subhanshu Gupta A Domotics Control Tool Based on MYO Devices and Neural Networks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 540 Santiago Luna-Romero, Paul Delgado-Espinoza, Fredy Rivera-Calle, and Luis Serpa-Andrade Biomimetical Arm Prosthesis: A New Proposal . . . . . . . . . . . . . . . . . . . . 549 Daniel Proaño-Guevara, Javier Procel-Feijóo, Johnny Zhingre-Balcazar, and Luis Serpa-Andrade

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Design of an Intelligent System for Prediction and Simulation of Writing in Children with Spasticity . . . . . . . . . . . . . . . . . . . . . . . . . . . 559 Luis Serpa-Andrade, Luis González-Delgado, Ana Parra-Astudillo, Isaac Ojeda-Zamalloa, Vladimir Robles-Bykbaev, and Roman Bunay Privacy and Security of Cardiovascular Implantable Electronic Devices: Applying a Contextual Integrity Analysis . . . . . . . . . . . . . . . . . . 569 Beth Strickland Bloch and Masooda Bashir Method of Ergonomics Assessment of Technical Systems and Its Influence on Operators Heath on Basis of Hybrid Fuzzy Models . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 581 Riad Taha Al-Kasasbeh, Nikolay Korenevskiy, Mahdi Salman Alshamasin, and Ilyash Maksim Hazard and Safety Analysis of the Integra™ UltraVS™ Neonate Valve . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 593 Amber Torrez Investigation of Human Factors Engineering Methods Used in Medical Device Procurement Process . . . . . . . . . . . . . . . . . . . . . . . . . . 600 Kelly C.D. Lobato, Carlos H.P. Mello, Ana P.S.S. Almeida, and Rodrigo M.A. Almeida Usefulness of Skin Punch Tools for Corneal Biopsy . . . . . . . . . . . . . . . . . 609 Lore Veelaert, Iris Boons, Anton Carmen, Julie Engelen, Nick Janssens, Clara Devriendt, Nadia Zakaria, and Guido De Bruyne Medical Device Design for Improving Orthostatic Hypotension During Supine-to-Stand (STS) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 618 Fong-Gong Wu and XIn-An Chen Author Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 631

Human Factors in the Healthcare Environment

Increasing Patient Safety Through Resilient Design: Using Human Factors Engineering and Environmental Support Mechanisms to Reduce Potentials of Hospital Acquired Infection Lisa Sundahl Platt1 ✉ and Michael Greene2 (

)

1

2

UMNSystems LLC, Nashville, TN, USA [email protected] Release Papers, Sappi North America, Westbrook, ME, USA [email protected]

Abstract. The ability to effectively curtail the spread of dangerous disease causing bacteria within care delivery environments is a growing concern with evolving challenges. Current research on inert surfaces role in facilitating micro‐ bial spread is becoming more salient [4–7]. Furthermore, the recognition that infection prevention and pathogen transfer processes reliant on human behavior alone are unsatisfactory to effective mitigation [7, 8]. Using the context and prin‐ ciples of Human Factors and Ergonomics and Resilience Engineering to employ environmentally-based design parameters that improve inherent surface resist‐ ance to pathogens could be a key factor to controlling their spread [10, 13–18]. The objective of this article is to compile evidence of emergent alternative strat‐ egies in promoting high reliability healthcare delivery system design to better understand how infection prevention surface technology and Human Factorsbased moderation can be studied in concert with one another and ultimately leveraged to their greatest effect. Keywords: Human factors · Infection prevention · Environmental surface technology · Biomimetic resilience engineering

1

Introduction

Statistics indicate that there are approximately 722,000 annually reported incidences for nosocomial disease and Hospital Acquired Infections (HAI) in U.S. acute care hospitals alone. These cases result in approximately 75,000 hospital deaths per year [1]. Behavior based models to augment safe care delivery, such as hand hygiene campaigns, have proven only marginally effective in reducing harmful microorganism spread within healthcare settings due to challenges in staff adherence [2]. Current estimates of clinical staff hand hygiene compliance rates in acute care settings indicate that they have plateaued at about 50% despite widespread education and adoption efforts [3].

© Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_1

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Another key system interface to consider in infection control process effectiveness is that of the conditions present in the healthcare built environment. For instance, recent investigation has demonstrated that several major nosocomial contaminants can colo‐ nize on hospital surfaces at concentrations sufficient for transmission to human beings [4]. Furthermore, these microbes can survive for extended periods of time on surfaces for even small amounts to easily be transferred to the hands or clothing of healthcare workers facilitating human and environmental cross-contamination of dangerous and potentially life-threatening pathogens [5]. Complicating this condition is the growing evidence that disinfection regimens and environmental pathogen reduction strategies that include antimicrobials and biocides may not only produce agents harmful to the health of human occupants but could also increase hazardous HAI producing organisms’ antibiotic resistance due to prolonged exposure to these compounds [6]. Additionally, environmental cleaning practices that would support infection control in healthcare settings are also often sub-optimal. Even with the amplified observance to enhanced environment of care cleaning procedures, current investigations indicate that fewer than 80% of surfaces directly adjacent to patient care are being cleaned at baseline intervals even with enhanced hospital hygiene protocols in place [7]. The commonality of this scenario is compounded by the personnel challenges that often occur within hospital housekeeping departments as well as frequent incorrect use of environmental disinfec‐ tants [8]. Clearly there is an imminent need for more dependable, resilient, and “systems based models” for determining how pathogens spread within care environments. Consid‐ ering the frequency of HAI and growing microbial antibiotic resistance is imperative to research reliable methods for ensuring patient and staff safety. Furthermore, there is a need to better understand the efficacy of targeted nosocomial risk reduction strategies that are adaptive to human response and behavior. Integrating microbial colonization resistant surfaces that have innate properties to prevent the growth of bacteria on hospital surfaces without potentially toxic additives or the aid of human interaction has recently received some attention by healthcare surface researchers [9]. This presents a new and possibly worthwhile strategy for increasing environment of care resilience to dangerous pathogen propagation on surfaces within the built environment.

2

Background

The science of Human Factors and Ergonomics (HF/E) focuses on how people (micro‐ ergonomics) or organizations (macroergonomics) adapt and accomplish process related goals in varying circumstances and environments [10]. Although the discipline of HF/E has been applied in multiple high risk industries to produce high reliability outcomes since the mid-20th century [11], it is a relatively new construct within health‐ care for improving the performance and quality of care delivery. In 2005 the National Academy of Engineering and the Institute of Medicine recommended the implementa‐ tion of HF/E and other systems engineering approaches to improve the reliability and consistency of patient and staff safety in healthcare settings [12]. The topic of Infection Prevention and meaningful HAI risk reduction is an area of care delivery that is of late garnering significant attention. Recent research employing Human Factors Analysis

Increasing Patient Safety Through Resilient Design

5

indicates that the barriers that currently exist in infection control process adherence in healthcare settings are both myriad and mutable in nature [13]. Although, Environmental Services (EVS) and clinical staff vigilance of high reliability infection prevention proto‐ cols are imperative to pathogen spread prevention, on their own this may be inadequate to the dependable control of the spread of harmful bacteria within the healthcare envi‐ ronment [7]. Furthermore, studies on the formation of biofilm on healthcare surfaces indicate that the concentration of disinfectant required to kill “sessile” or anchored bacteria can be 10–1000 times higher than that required to kill free-floating (planktonic) bacteria [14]. These requirements for successful remediation of dangerous pathogens from healthcare surfaces present circumstances that make it both potentially harmful and difficult for human beings to successfully achieve these ends through typical envi‐ ronmental cleaning mechanisms [15]. Due to the multivariate, ecological and operational systems within care environments it may be reasonable to posit that a user-centered approach employing HF/E and prin‐ ciples of Resilience Engineering could be effective in reducing pathogen transference risk factors within care environments. The analysis of risk within environments of care needs to commence with a thorough understanding of actual endogenous and exogenous variable interaction [16]. More simply put, there needs to be a comprehensive assessment of how environmental and human factors, and their interaction with one another, might contribute to adverse outcomes. Using this as a framework for reducing the probability of microbial spread could augment feasibility of health system goals for enhancing the performance of both the healthcare environment and the individuals charged with effec‐ tively maintaining it. An HF/E approach to environmental Resilience Engineering recognizes that process inefficiency and errors will occur for a variety of reasons in complex and dynamic circumstances [17]. Gaps in infection control systems design, often appears to be in part exacerbated by underperforming strategies for supporting effective human and “envi‐ ronmental surface systems” integration. Rather than an over-reliance on human behavior to adhere to using processes that are not adaptive to variance within the contexts they operate, an HF/E approach to microbial risk reduction might use data related to exoge‐ nous interfaces, in this case healthcare surface to human transmission, to design resilient parameters within the interface itself [18]. This calls for a new approach to evaluating healthcare surface design standards and their ability to support the Health Safety and Welfare (HSW) requirements of human occupants.

3

Case Study Results and Healthcare Safety Implications

There is great potential for employing novel yet reliable environmentally based inter‐ ventions along with HF/E approaches that could effectively impact the spread of patho‐ gens in healthcare environments. These environment design interventions might over time consequentially offer care settings instrumental in reducing risks of HAI and noso‐ comial disease. One such innovation, uses micropatterning on casting and release paper that when applied to cast (coated fabrics, films, etc.) or laminate substrates has demon‐ strated disruption of the spread of bacteria on treated surfaces. This surface technology

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referred to as Neoterix™ ST, employs a bio-inspired microstructure on the surface known as Sharklet™ (Fig. 1). Manufacturers of cast or laminated substrates use Neoterix™ ST release paper to impart the microstructure on the surface of commercial products. This technology’s inception was the outcome of surface antifouling research by Dr. Anthony Brennan, a materials science and engineering professor at the University of Florida, and sponsored by the U.S. Office of Naval Research [19]. Dr. Brennan’s primary goal was to create an engineered topography that could prevent the settlement of microorganisms on the surface of naval sea going vessels [20]. Compelled by data relating to shark skin’s natural ability to remain relatively free from microbial growth, Brennan used a mathematical model to develop a raised pattern that would significantly limit the ability of environmental pathogens to colonize on surfaces to which it was applied [21]. The application of this innovative example of biomimetic engineering was later developed through collaboration with Sharklet™ Technologies, Inc. and Sappi North America into a reusable release paper that would allow the Sharklet™ pattern to be imparted onto different surfaces during the manufacturing process. This new tech‐ nology currently allows for the creation of certain resilient and coated finishes to emulate the microscopic patterning found on a shark’s skin through a sophisticated manufac‐ turing process. Essentially, this creates a scenario that allows for greater real-world applicability of this surface technology. This consequentially provides substrates whose surface topography has tested as resistant to microbial colonization (both attachment and growth).

Fig. 1. Sharklet micropattern (left) and magnified shark skin (right.)

The Sharklet™ micropattern has demonstrated a 90–95% efficacy level at keeping treated surfaces bacteria free in controlled surface application trials1. Current research in healthcare surface pathogen exchange indicates that there is an increased risk of surface to person and person to person transference of methicillin-resistant S. aureus (MRSA) in environments that have been previously occupied by infected patients [22]. When tested alongside antimicrobial and control surfaces in real world surface inocu‐ lation simulation trials the Sharklet™ micropattern demonstrated a 94% resistance to 1

Perfectus Biomed. Sharklet 002 Report ID: PB041-002-V1 Evaluation of Microorganisms Colonization on Plastic Surfaces. May 26. (2016).

Increasing Patient Safety Through Resilient Design

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surface colonization of methicillin-sensitive Staphylococcus aureus (MSSA) and a 97% resistance to surface colonization by MRSA [23]. Micropattern and untreated surfaces were analyzed in clinical simulation testing designed to observe human transmission of bacteria onto adjacent surfaces in patient treatment settings. This study demonstrated a 13-fold reduction in transfer to the defibrillator button, which had been treated with the Sharklet™ micropattern, or about a 1.1 log reduction in bacterial transfer when compared to a one left untreated by this technology. Log reduction values of vials and carts treated with the Sharklet™ micropattern in this simulation study also demonstrated 4.4 and 3.8-fold reduction in bacterial transfer respectively.2 A unique property of the micropattern is that it does not introduce anti-microbial agents to the product composition; instead the surface microstructure inherently provides microbial resistance. This is an important consideration when determining integration of environmental system parameters that can be resilient to the variability of pathogen spread and prevalence and actual human use and maintenance practices. However, in order to preserve micropattern surface integrity, further optimization of product properties attributes will need to be done to maintain resistance to wear and cleaning protocols.3 Field-based research will provide critical data to better understand variables that impact these factors. The emergent field of Resilience Engineering (RE) centers on designing system parameters that anticipate the inevitability of various, and potentially unknown, sources, of risk rather than strictly focusing on known factors that consequentially lead to adverse events [24]. RE is the integral capability of system functions to be adaptive to multiple scenarios and stresses that may disrupt planned outcomes [25]. When RE is viewed within in the context of ecological design, there is an emphasis on developing and implementing system features that can absorb disturbances before they change variables that have the potential to implicitly influence outcomes [26]. Resilient surface engi‐ neering, such as micropatterning, that naturally reduced pathogen transference through inherent colonization resistance, could have important implications. This anticipatory approach for improving microbial spread risk reduction through the introduction surface topography manipulation may offer critical contributions to promoting patient and staff safety in high-risk complex systems such as healthcare.

4

Discussion and Limitations

Understanding the nuances of the interactions between environmentally-based systems and the humans that interface with them is essential to improving the reliability of patient 2

3

Mettetal, M.R; Drinker, M.C; May, R.M; Parker, A.E; Sande, M.K; Stevenson, B.C; Mann E.E; Reddy, S.T. Surface Micropattern Resists Bacterial Contamination Transferred by Health‐ care Practitioners. Sharklet Technologies, Inc. Aurora, CO. In cooperation with the Center for Biofilm Engineering and Department of Mathematical Sciences; Montana State, Bozeman, MT; Work Education and Lifelong Learning Simulation Center of Colorado Hospital, Aurora, CO. Adapted from Sappi North America. Neoterix™ ST the Sharklet™ Story. Used with the permission of Sappi North America. (2017).

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and staff safety [27]. In Healthcare Architecture/Design, Engineering, Construction and Facility Operations HSW criteria has always been a key component in dictating the selection, installation, and maintenance of healthcare surfaces. However, until recently there has been a disconnect and lack of appreciation of the impact these surfaces have on pathogen transference to humans. Although the outcomes of the Sharklet™ surface micropatterning case study research and control trials are compelling they do not provide enough credible evidence on their own to demonstrate HAI risk reduction potential. It is not the intention of the authors to imply proven prevention between micropattern surface topography integration and reduced rates of dangerous pathogen spread and HAI. The objective of this article and the ongoing efforts of the Neoterix™ ST imple‐ mentation research team is to continue to compile credible evidence of an emergent alternative strategy in promoting high reliability healthcare delivery system design. The aim of this work is to better understand how environmental and human-based infection prevention strategies in care delivery can be studied in concert with one another and leveraged to their greatest effect. The need to expand in situ investigation of healthcare surface technologies ability to impact microbial spread is critical. The advent of antimicrobial resistant pathogens such as Carbapenem-resistant Enterobacteriaceae (CRE) makes the necessity to better understand the prevalence and persistence of antibiotic resistance dire [28]. Further‐ more, it is becoming clearer that reliance on behavior based infection prevention strat‐ egies cannot be depended upon to deliver optimal effects in infection risk reduction. Individuals at the center of process and place based care delivery systems are both influenced by and enact influences upon the systems with which they interact [16]. Few systems within the healthcare built environment are as pervasive as the surfaces and applied finishes that comprise them. Using resilient technologies like environmental surface micropattern to combat microbial spread and bioburden in concert with HF/E strategies could be a worthwhile endeavor. This may provide new and dependable ways to reduce dangerous pathogen transference and ultimately make patients and staff safer in care delivery environments.

5

Conclusion and Future Direction

The intent of this paper is to provide an overview of tested engineered and quality improvement solutions organized around user-centered strategies for decreasing micro‐ bial exchange in healthcare environments. The hope is that the ideas the authors have put forth in this article will elicit greater interest in the role that environmental support mechanisms, such as surface design, play in healthcare infection prevention. At present the research that investigates the role that surfaces play in pathogen transference is very limited. Expanding these analyses within Human Factors and Resilient Engineering frameworks would seem to offer great potential for extracting critical human to system interface themes. Over time this might offer unparalleled insight into how we can better design environments of care to serve as tools in HAI reduction strategies.

Increasing Patient Safety Through Resilient Design

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Acknowledgements. Lisa Sundahl Platt is the Founder/CEO of UMNSystems LLC, a paid consultant of Sappi North America. Mike Greene is currently an employee of Sappi North America, manufacturer of Neoterix™ ST release paper. The authors of this work contributed to the concept formulation and supportive literature review. Both contributed to the writing, revision, and read and approved the final manuscript.

References 1. Magill, S., Edwards, J., Bamberg, W., Beldavs, Z., Dumyati, G., Kainer, M., Fridkin, S.: Multistate point-prevalence survey of health care-associated infections. N. Engl. J. Med. 370(13), 1198–1208 (2014) 2. Shekelle, P.G., Wachter, R.M., Pronovost, P.J., Schoelles, K., McDonald, K.M., Dy, S.M., Shojania, K., Reston, J., Berger, Z., Johnsen, B., Larkin, J.W., Lucas, S., Martinez, K., Motala, A., Newberry, S.J., Noble, M., Pfoh, E., Ranji, S.R., Rennke, S., Schmidt, E., Shanman, R., Sullivan, N., Sun, F., Tipton, K., Treadwell, J.R., Tsou, A., Vaiana, M.E., Weaver, S.J., Wilson, R., Winters, B.D.: Making health care safer II: an updated critical analysis of the evidence for patient safety practices. Comparative Effectiveness Review No. 211. (Prepared by the Southern California-RAND Evidence-based Practice Center under Contract No. 290-2007-10062-I.) AHRQ Publication No. 13-E001-EF. Rockville, MD: Agency for Healthcare Research and Quality, March 2013 (2013). www.ahrq.gov/research/findings/ evidence-based-reports/ptsafetyuptp.html 3. Mcguckin, M., Govednik, J.: A review of electronic hand hygiene monitoring: considerations for hospital management in data collection, healthcare worker supervision, and patient perception. J. Healthc. Manag. 60(5), 348 (2015) 4. Dancer, S.: Controlling hospital-acquired infection: focus on the role of the environment and new technologies for decontamination. Clin. Microbiol. Rev. 27(4), 665–690 (2014) 5. Otter, J., Yezli, S., French, G.: The Role Played by Contaminated Surfaces in the Transmission of Nosocomial Pathogens. Infect. Control Hosp. Epidemiol. 32(07), 687–699 (2011) 6. Meyer, B., Cookson, B.: Does microbial resistance or adaptation to biocides create a hazard in infection prevention and control? J. Hosp. Infect. 76(3), 200–205 (2010) 7. Carling, P., Parry, M., Rupp, M., Po, J., Dick, B., Von Beheren, S.: Improving cleaning of the environment surrounding patients in 36 acute care hospitals. Infect. Control Hosp. Epidemiol. 29(11), 1035–1041 (2008) 8. Boyce, J.: Modern technologies for improving cleaning and disinfection of environmental surfaces in hospitals. Antimicrob. Resist. Infect. Control 5(1), 10 (2016) 9. Weber, D.J., Rutala, W.A.: Self-disinfecting surfaces: review of current methodologies and future prospects. AJIC. Am. J. Infect. Control 41(5), S31–S35 (2013). (Report) 10. Hendrick, H., Kleiner, B.M.: Macroergonomics: An Introduction to Work System Design. Human Factors and Ergonomics Society, Santa Monica (2001) 11. HFES History, Human Factors and Ergonomics Society. https://www.hfes.org/web/ AboutHFES/history.html. Accessed 26 Feb 2017 12. Reid, P.R., Compton, W.D., Grossman, J.H., Fanjiang, G.: Building a Better Delivery System. A New Engineering/Health Care Partnership. The National Academies Press, Washington, D.C (2005) 13. Yanke, E., Zellmer, C., Van Hoof, S., Moriarty, H., Carayon, P., Safdar, N.: Understanding the current state of infection prevention to prevent Clostridium difficile infection: a human factors and systems engineering approach. AJIC. Am. J. Infect. Control 43(3), 241–247 (2015)

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14. Simoes, M.: Antimicrobial strategies effective against infectious bacterial biofilms. Curr. Med. Chem. 18(14), 2129–2145 (2011) 15. Abreu, A., Tavares, R., Borges, A., Mergulhao, F., Simoes, M.: Current and emergent strategies for disinfection of hospital environments. J. Antimicrob. Chemother. 68(12), 2718– 2732 (2013) 16. Carayon, P., Wood, K.: Patient safety - the role of human factors and systems engineering. Stud. Health Technol. Inf. 153, 23–46 (2010) 17. Carayon, P., Wetterneck, T.B., Rivera-Rodriguez, A.J., Hundt, A.S., Hoonakker, P., Holden, R., Gurses, A.P.: Human factors systems approach to healthcare quality and patient safety. Appl. Ergon. 45(1), 14–25 (2014) 18. Village, J., Searcy, C., Salustri, F., Neumann, W.: Design-for-human factors (DfHF): a grounded theory for integrating human factors into production design processes. Ergonomics 58, 1–34 (2015) 19. Sharklet Technologies, Inc. Inspired by Nature the Discovery of Sharklet (2017). http:// sharklet.com/our-technology/sharklet-discovery/. Accessed 1 Mar 2017 20. Schumacher, J.F., Carman, M.L., Estes, T.G., Feinberg, A.W., Wilson, L.H., Callow, M.E., Callow, J., Finlay, J., Brennan, A.B.: Engineered antifouling microtopographies–effect of feature size, geometry, and roughness on settlement of zoospores of the green alga Ulva. Biofouling 23(1), 55–62 (2007) 21. Kirschner, C., Brennan, A.: Bio-inspired antifouling strategies. Annu. Rev. Mater. Res. 42, 211–229 (2012) 22. Huang, S., Datta, R., Platt, R.: Risk of acquiring antibiotic-resistant bacteria from prior room occupants. Arch. Intern. Med. 166(18), 1945–1951 (2006) 23. Mann, E., Manna, D., Mettetal, M., May, R., Dannemiller, E., Chung, K., Brennan, A., Reddy, S.: Surface micropattern limits bacterial contamination. Antimicrob. Resist. Infect. Control 3, 28 (2014) 24. Fairbanks, R.J., Wears, R.L., Woods, D.D., Hollnagel, E., Plsek, P.: Resilience and resilience engineering in health care. Health Care (Don Mills) 14(3), 253–260 (2012) 25. Azadeh, A., Zarrin, M.: An intelligent framework for productivity assessment and analysis of human resource from resilience engineering, motivational factors. HSE and ergonomics perspectives. Saf. Sci. 89, 55–71 (2016) 26. Hollnagel, E.: Resilience engineering and the built environment. Build. Res. Inf. 42, 1–8 (2013) 27. Waterson, P.: A critical review of the systems approach within patient safety research. Ergonomics 52(10), 1185–1195 (2009) 28. US Department of Health and Human Services: Antibiotic resistance threats in the United States, 2013. CDC, Atlanta (2013)

An Ergonomic Evaluation of Preoperative and Postoperative Workspaces in Ambulatory Surgery Centers Deborah Wingler ✉ , Anjali Joseph, and Rutali Joshi (

)

Center for Health Facilities Design and Testing, Clemson University, Lee Hall 2-105, Fernow Street, Clemson, SC 29634, USA {dwingle,anjalij,rjoshi}@clemson.edu

Abstract. Healthcare organizations are faced with the challenge of renovating existing infrastructure or building new facilities to enable the inclusion of computer workstations and address growing technological demands. The majority of existing ergonomic tools for evaluating computer workstations primarily focus on the interface between the care provider and the computer. This paper describes the development and application of an expanded ergonomic eval‐ uation framework that focuses on the work system versus the workstation. The tool was tested and refined through visits to five facilities where the ergonomic evaluation tool was used to assess five preoperative and seven postoperative rooms/bays in surgical suites with varying spatial configurations and types of workstations. The comparative evaluation showed that all workstations met most of the basic checklist requirements, but there were significant differences related to the location of the workstation and adjacencies to other zones in how effectively the workstations were integrated into the space. Keywords: Healthcare · Ergonomic · Workstation · Evaluation · Work system

1

Background

The number of ambulatory Surgery Centers (ASCs) has rapidly expanded over the last two decades from 1,000 in 1998 to over 5,400 in 2016 due to the dramatic increase in the number of surgical procedure being conducted in outpatient settings in the United States each year [1]. To improve the quality of care, an influx of $20 billion for the investment of infra‐ structure and systems to support the implementation of health information technology (HIT) was inserted in 2009 into the US healthcare system with the American Recovery and Reinvestment Act [2]. As a result, computers have been incorporated into the clinical workflow in a diverse range of healthcare settings. The inclusion of healthcare infor‐ mation technology (HIT) has transformed the ambulatory surgical environment by increasing the amount of computer work that is done by care team members while in the presence of patients and their care partners.

© Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_2

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Healthcare facilities are faced with the challenge of renovating existing facilities to enable the inclusion of computer workstations, incorporating solutions that may work within the constraints of their existing environments or building new facilities that are able to address growing technological demands. While some tools exist to provide guidance for comparing ergonomics of alternative computer workstation configurations, these tools primarily focus on the interface between the care provider and the computer [3–5]. Given the significant impacts of the computer workstation on the interactions between care provider and patient and care provider and family members in healthcare settings [6, 7], there is an urgent need for an expanded ergonomic evaluation framework that considers the ergonomics of the workstation within the broader work system within which it may be placed. This paper aims to fill the gap through the development and application of an expanded ergonomic evaluation framework that focuses on the work system versus the workstation. 1.1 Study Objectives The key objectives of this study include: 1. To develop an ergonomic evaluation framework and design tool that focuses on the work system versus the workstation in preoperative and postoperative work spaces in ambulatory surgery centers 2. To compare various applications of technology integration within preoperative and postoperative work systems in ASCs

2

Methods

This study included literature reviews and evaluation of existing tools to develop an expanded ergonomic evaluation framework and tool. The tool was tested and refined through visits to five facilities where the ergonomic evaluation tool was used to assess five preoperative and seven postoperative rooms/bays in surgical suites with varying spatial configurations and types of workstations. 2.1 Development of the Clemson Healthcare Work System Ergonomic Assessment Existing tools for evaluating workstations within a healthcare context were first identi‐ fied through the literature. Design criteria established in the literature for designing ergonomic medical equipment, healthcare environments and HIT were also reviewed. From this review, the Cornell Healthcare Computer Wall-Station Ergonomic Checklist [3] was chosen as the base for developing the Clemson Healthcare Work System Ergo‐ nomic Assessment. The Cornell Healthcare Computer Wall-Station Ergonomic check‐ list is comprised of 20 items that are formatted as a series of questions that require a “yes” or “no” response [3]. To modify the existing tool, items pertaining specifically to a wall mounted system or individual technology were first removed. Questions around visual and auditory connections between patient, provider and family were then added

An Ergonomic Evaluation of Preoperative and Postoperative

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to the checklist based upon design principles identified in a previous study conducted by the authors [8, 9]. The checklist was further expanded to include concepts identified in the literature as enhancing staff work performance through flooring attributes asso‐ ciated with comfort underfoot and slip resistance [10], the inclusion of horizontal work‐ space [8, 11], criteria regarding spatial connectivity to medication and central supplies [12], as well as views to the outdoors [13]. Furthermore, the checklist was modified to facilitate rating of multiple, usable configurations for the same workstation for select criteria. Sections were then added to the ergonomic assessment pertaining to workstation usability and the spatial context surrounding the workstation. The Clemson Healthcare Work System Ergonomic Assess‐ ment is organized into the following 5 key sections to support a holistic work system analysis, as shown in Table 1. Table 1. Components of The Clemson Healthcare Work System Ergonomic Assessment Components Context and task analysis

28 item checklist Photo protocol Documentation of insights and challenges

Physical assessment of space

Assessment criteria Questions regarding facility area, workstation type, task sequence and task identification and identification of usable configurations 16 general questions and 12 questions for each usable configuration A minimum of 8 photos of from varying perspectives within the space Additional notable aspects of the environment, such as the existence of excessive electrical cords Marking the location of 12 environmental features, a minimum of three standard measurements and information regarding the type of enclosure around the room/bay to scale on graph paper

2.2 Application of Ergonomic Assessment The ergonomic assessment was conducted, along with a task analysis, semi-structured interviews with nurses and a physical and photo assessment in five facilities with varying workstation configurations in their preoperative and postoperative workspaces to iden‐ tify the facilitators and barriers to each workstation design. For this study, three types of workstation designs were evaluated: a wall mounted workstation, workstation on wheels (WoW) and a boom mounted workstation. These workstations were selected for this study as they represent the most typical type of platforms for integrating technology into new and existing ambulatory surgical workspaces. The task analysis involved asking nurses to walk through and verbally describe the sequence of activities that they would typically perform in their workspace. Semi-struc‐ tured interviews were conducted with a preoperative or postoperative nurse following the task analysis in the workspace to identify facilitators and barriers related to

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workstation functionality/usability. This was followed by the evaluation of the work‐ space using the 28-item checklist, photo documentation and physical assessment of the space.

3

Analysis

Based upon the location of seven essential environmental features within each work‐ space, a zoning distribution plan, consisting of five key zones, was first developed for each workspace. Table 2 shows the zones and their definitions. Table 2. Zone distribution and definitions Zone Workstation Staff Movement Care Partner Support Supply

Definition Area that encompasses the workstation and vital monitors Area around patient bed where direct patient care activities occur Area where seating for the care partner is located Area that supports the movement of equipment and care team members Area where direct patient care supplies, sharps and hand sanitizer are located

The zoning distribution was first anchored by demarcating a 1½ ft. area around all sides of the patient bed for the staff movement zone, designating the space required to comfortably support direct patient care activities from a standing position, as identified during the task analysis and interviews with staff. Where a 1½ ft. area was not viable, the staff movement zone was occluded at the nearest enclosure, piece of equipment or furniture. The workstation zone was then demarcated in plan based on the greatest extent to which any of the usable configurations could extend into the workspace. The supply and care partner zones were then overlaid into the plan based on the maximum square footage required to accommodate manufacturer design specifications. The support zone was then inlaid into the remaining available space. Measurements regarding the minimum space requirements (3 ft.) from the side and foot of the bed to the adjacent enclosure as identified by the FGI guidelines [14] were then placed into each zoning distribution plan to determine the availability of adequate space between the patient bed and surrounding enclosure. The 12 preoperative and postoperative configurations were then visually compared to understand differences in spatial configuration and size of different zones, and the potential impacts of these configurations based on criteria developed from the interviews and evaluation. Table 3 shows the criteria associated with each zone for evaluating their effectiveness in supporting nursing work practices and the patient and care partner experience. The work systems were also compared in terms of how the workstation design and usable configurations afforded clear sightlines between the care provider and patient, care provider and care partner and patient and care partner. The strengths and limitations of different individual workstations are also compared and discussed.

An Ergonomic Evaluation of Preoperative and Postoperative

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Table 3. Zoning distribution and evaluation criteria Zone Workstation zone

Staff Movement zone Care Partner zone Support zone

Supply zone

4

Criteria for evaluation Easy access to supplies for direct patient care activities; visibility to both patient and care partner simultaneously from the most commonly used configuration; space optimization; ease of physical access to patient Ability to access patient from all sides; accessibility to direct patient care supplies Visibility to patient and staff simultaneously; not in the direct path of staff travel patterns Unobstructed space to accommodate the circulation of multiple care team members; unobstructed space to accommodate the flow of additional equipment Co-location of direct patient care supplies; accessibility of sharps to direct patient care activities; accessibility visibility of hand sanitizer to care team members

Findings

4.1 Overall Workstation Design Across all sites, each type of workstation accommodated standard anthropometric meas‐ urements for both standing and seated positions, independent component adjustments, ergonomic keyboard positions, easily cleanable surfaces, integrated horizontal work surfaces and multiple usable configurations. Additionally, all workstations provided inte‐ grated cord management other than the wall mounted workstations at Site 3 and Site 5. Each pre and postoperative workspace met the minimum spatial requirements of an overall clear floor area of 80 sq. ft. for a pre or postoperative bay and an overall clear floor area of 100 sq. ft. for pre or postoperative rooms as outlined by the FGI guidelines [14], with the exception of the postoperative bay at Site 2. Although all workstations afforded a seating position, three of the preoperative workspaces (Site 1, Site 2 and Site 4) and three of the postoperative workspaces (Site 1, Site 4 and Site 5) did not provide a seating option due to space constraints. While all workstations did provide a horizontal work surface, the workspaces in Site 2 that utilized WoWs for the workstation added bedside tables into the work system to provide additional horizontal surfaces for setting paper charts and signing consent forms. The addition of the bedside table added clutter to the already spatially constrained area at this site. While each workstation provided a viable ergonomic design solution for integrating technology into the workspace, differ‐ ences were found in terms of how the workstation was integrated within the work system. 4.2 Integration of Workstation into the Work System The type of workstation that was used, its location within the space and adjacencies between workstation and other zones impacted how well the workstation was integrated within the work system. The design of the workstation and the size of the bay impacted

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how well the different zones functioned in supporting different tasks. Figure 1 shows the relationship between zones for the pre and postoperative workspaces at the five sites.

Fig 1. Relationship between zones for pre & post op workspaces at the 5 sites

An Ergonomic Evaluation of Preoperative and Postoperative

17

Workstation Zone. Experientially, the varying workstation designs and their place‐ ment within the pre and postoperative workspaces resulted in varying effectiveness for supporting key perioperative tasks for care team members. While the boom mounted workstations in the preoperative room at site 1 provided co-location of workstation, direct patient care supplies and vital monitors, the boom protruded into the support and staff movement zones, leaving a significant amount of unusable space behind the boom. Additionally, the shared boom in the postoperative bay did not provide co-location of direct patient care supplies, creating decreased accessibility to those supplies. The WoWs at site 2 introduced constraints into the work system due to their size and placement. Limited space within the pre and postoperative bays required the WoWs to be placed outside the bays in the hallway, making it difficult to access vital monitors as well as direct patient care supplies from the workstation. This fragmentation extended into the support zone in the postoperative bay, leaving nominal room for additional care team members. Although the wall mounted workstations integrated into sites 3, 4 and 5 utilized the least amount of space within the work system, not all provided usable configurations that supported communication between care team member, patient and care partner simultaneously. However, due to the limited spatial requirements needed by the wallmounted workstations, the sites with integrated wall mounted workstations resulted in more continuous support zones with greater area to support the presence of additional care team members. Staff Movement Zone. While the size and location of the staff movement zone varied between the different types of workstations and room/bay configuration, two of the sites that utilized the wall mounted workstations (Site 3 and Site 4) afforded the placement of the bed to be central to the pre and postoperative rooms/bays. This centrality provided closer adjacencies to components in the work system such as the sharps container, direct patient care supplies and gloves that support direct patient care activities. The central location of the bed also supported greater access to multiple surgical site locations on either side of the patient. Limitations with the staff movement zone were identified in pre and postoperative bays at Site 2 and the postoperative bay at Site 5. Due to the integration of the WoWs into the work system, both sites were unable to achieve an adequate staff movement zone, restricting the ability of care team members to perform direct patient care activities without impeding on the care partner zone. The placement of the staff movement zone in the preoperative room at Site 1 with the integrated boom did not impede the care partner zone. However, access to the patient was primarily restricted to the right side of the patient, as access to the patient’s left side would place undue strain on the care team member due to lack of space. Care Partner Zone. Across all sites, the location of the care partner zone varied greatly. In addition to impeding staff movement around the patient bed at two of the sites, the location of the care partner zone was found to restrict care team members access to supplies in the preoperative bay at Site 1. In this bay, the care partner space is located directly under the hand sanitizer, requiring care team members to ask care partners to

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move each time they use the hand sanitizer. Although the placement of the care partner zone did not impede on the staff movement zone in the preoperative room at Site 4, it was found that the zone itself was spatially constrained for accommodating two adults. This is notable for this particular workspace, as this work system was designed to opera‐ tionally support parent participation during induction for both parents. Support Zone. The greatest restriction to the movement of additional equipment and care team members was found in the pre and postoperative workspaces at Site 2. This fragmentation of the support zone can be partially attributed to the spatial constraints of the bays in addition to the placement to other components in the work system. However, this same fragmentation can also be observed in the preoperative roommate Site 4. Interestingly, this is one of the preoperative workspaces with the greatest overall clear floor area at 141.03 sq. ft. This fragmentation can be attributed to the anesthesia work‐ station that permanently resides in the preoperative workspace at this site, restricting the movement of any additional equipment within the workspace. Interestingly, only pre and postoperative workspaces at Site 3 and the postoperative roommate Site 4 allow for the continuous flow of additional equipment and care team members around three sides of the staff movement zone. These work systems were identified as providing maximum support for direct patient care activities. Supply Zone. Fragmentation of the supply zone also created challenges in the flow of the work system. Due to the position of supplies on opposite sides of the bed in the postoperative bays at Site 2 and Site 5 and preoperative room at Site 4, care team members are required to go around the bed to retrieve supplies for performing direct patient care activities. While this fragmentation can be seen in the preoperative room at Site 3, the distance between supplies was reduced by being positioned at the foot of the patient bed instead of near the head of the patient bed. The greatest support for direct patient care activities was found in the preoperative rooms at Site 3 and Site 5 and the postoperative rooms at Site 3 and Site 4 where the supply zone was non-fragmented and adjacent to the workstation zone. Visibility. Maintaining visual connectivity between care team members, patient and care partner is vital for supporting the critical interactions that occur during the pre and postoperative phases of the ambulatory surgical process. Figure 2 shows care team member cone of vision to patient and care partner from the workstation. In the preop‐ erative workspaces at Site 1 and Site 2, as well as in the in the postoperative workspace at site 4, there was restricted visibility to the care partner from the workstations. Addi‐ tionally, restricted visibility from the workstation to the patient was observed in the postoperative room at Site 4 and the preoperative room at Site 5. Only Site 3 afforded visibility between the care team member, patient and care partner simultaneously for all usable configurations in both the preoperative and postoperative workspaces. However, Site 2 and Site 4 afforded non-restricted visibility to both the patient and care partner in the postoperative and preoperative workspaces, respectively.

An Ergonomic Evaluation of Preoperative and Postoperative

Fig 2. Care team member cone of vision to patient & care partner

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Discussion

The comparison of the 12 work systems highlighted the critical impacts of the work‐ station design (type, location) on task performance in the space. By applying the Clemson Healthcare Work System Ergonomic Assessment tool in the five ambulatory surgery facilities the team was also able to assess the effectiveness and usability of the tool. This comparative study also helped in the development of a visual analytic tech‐ nique (zoning diagrams) to support comparison among alternative configurations. The comparative evaluation showed that all workstations met most of the basic checklist requirements, but there were significant differences in how effectively the workstations were integrated into the space. These differences related to the size of the overall space, the location of the workstation, adjacencies to other zones and the extent to which the workstation zone intruded into and fragmented other zones within the work system. Thus, the study highlights the fact that it is not enough to evaluate the ergonomic and anthropometric properties of the workstation in isolation while making implemen‐ tation decisions. Rather, it is critical to consider key relationships between the work‐ station and other zones that staff members need to access physically and visually. Such an evaluation also allows the team to be aware of potential conflicts or tradeoffs that might need to be made. The analysis of the room via the zoning diagrams was not part of the original tool but was an analytic technique developed by the research team as a way of evaluating the impact of the workstation on other zones (defined through the tasks analysis) within the system. This spatial analysis was critical in understanding the relationship of the components within the workstation. As a result, the steps undertaken by the research team to conduct the visual analysis was incorporated into the tool to guide future users in moving from the evaluation to analysis. While the tool was not used in this study to design a new space, the elements in the checklist as well as the process developed to create the zoning diagrams may support a proactive approach to evaluating evolving design ideas. The assessment tool and zoning diagrams are useful both as a proactive design tool and also as part of an ergonomic evaluation of an existing workstation.

6

Limitations

This study evaluated three different types of workstations implemented in multiple different settings. As a result, we were not able to separate the impact of the workstation from the constraints of the different layouts (e.g. area, type of enclosure) in which they were implemented. The comparison could have been stronger if the three different types of workstations had been implemented into the same space. While this would be possible in an experimental environment, this study focused on understanding existing work systems within their contextual reality. A future next step might be to design a single bay with different workstation configurations and evaluate their relative performance through virtual reality or physical mock-up simulations.

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References 1. Ambulatory Surgery Center Association. http://www.ascassociation.org/advancingsurgical 2. Steinbrook, R.: Health care and the American recovery and reinvestment act. N. Engl. J. Med. 360(11), 1057–1060 (2009) 3. Cornell University Ergonomics Web. http://ergo.human.cornell.edu/ahWALLS.htm 4. Cornell University Ergonomics Web. http://ergo.human.cornell.edu/ahWOWs.htm 5. Janowitz, I.L., Gillen, M., Ryan, G., Rempel, D., Trupin, L., Swig, L., Mullen, K., Rugulies, R., Blanc, P.D.: Measuring the physical demands of work in hospital settings: design and implementation of an ergonomics assessment. Appl. Ergon. 37(5), 641–658 (2006) 6. Pearce, C., Dwan, K., Arnold, M., Phillips, C., Trumble, S.: Doctor, patient and computer— a framework for the new consultation. Int. J. Med. Inform. 78(1), 32–38 (2009) 7. Saleem, J.J., Flanagan, M.E., Russ, A.L., McMullen, C.K., Elli, L., Russell, S.A., Bennett, K.J., Matthias, M.S., Rehman, S.U., Schwartz, M.D., Frankel, R.M.: You and me and the computer makes three: variations in exam room use of the electronic health record. J. Am. Med. Inform. Assoc. 21, 147–151 (2014) 8. Joseph, A., Wingler, D., Zamani, Z.: Balancing the human touch with the need for integrating technology in ambulatory surgical environments: barriers and facilitators to nursing work and care team interactions. J. Inter. Des. 42(1), 39–65 (2017) 9. Cai, H., Zimring, C.: Out of sight, out of reach: correlating spatial metrics of nurse station typology with nurses’ communication and co-awareness in an intensive care unit. In: Proceedings of the 8th International Space Syntax Symposium, Santiago, Chile, vol. 36 (2012) 10. Cham, R., Redfern, M.S.: Effect of flooring on standing comfort and fatigue. Hum. Factors 43(3), 381–391 (2001) 11. Lawler, E.K., Hedge, A., Pavlovic-Veselinovic, S.: Cognitive ergonomics, socio-technical systems, and the impact of healthcare information technologies. Int. J. Ind. Ergon. 41(4), 336– 344 (2011) 12. Mahmood, A., Chaudhury, H., Valente, M.: Nurses’ perceptions of how physical environment affects medication errors in acute care settings. Appl. Nurs. Res. 24(4), 229–237 (2011) 13. Shepley, M.M., Gerbi, R.P., Watson, A.E., Imgrund, S., Sagha-Zadeh, R.: The impact of daylight and views on ICU patients and staff. HERD Health Environ. Res. Des. J., 5(2), 46– 60 (2012) 14. AIA F: Guidelines for Design and Construction of Health Care Facilities. American Institute of Architects, Washington DC (2014)

Characteristics of United States Military Personnel and Veterans Who Complete Mindfulness Training Baoxia Liu1 and Valerie J. Rice2(&) 1

2

DCS Corporation, Alexandria, VA, USA [email protected] Army Research Laboratory, Ft. Sam Houston, San Antonio, TX, USA [email protected]

Abstract. Research demonstrates mindfulness training (MT) benefits military personnel by reducing stress [1] and maintaining working memory [2]. However, learning mindfulness meditation takes time and dedication to cultivate contemplative skills and face one’s personal struggles. This study investigated the personal characteristics of research volunteers who completed MT, taught in-person (IP) or in a Virtual World (VW), compared with those who did not complete training. Volunteers (n = 160) completed a demographic questionnaire, the Mindful Awareness and Attention Scale, and the Posttraumatic Stress Disorder Checklist-Military version before beginning MT. For the IP group, a higher percentage of females completed training than males. For the VW group, those who finished training were slightly older, more mindful, and did not meet the criteria for a presumptive diagnosis of Posttraumatic Stress Disorder (PTSD). The results suggest that women, those with PTSD, and those who are less mindful may complete and receive greater benefit from MT offered in-person. Keywords: Dropout


Participation
PTSD
MAAS
MBSR
Meditation

1 Introduction Mindfulness meditation is a particular type of meditation based on Vipassana, i.e. Insight Meditation. Jon Kabat-Zinn [3] introduced mindfulness meditation to Western Medicine in the form of Mindfulness-based Stress Reduction (MBSR). During MBSR training, attendees participate in a series of gentle practices to help them focus and pay attention to the physical sensations of their own breathing and body (touch, hot and cold, internal comfort and discomfort, pressure, kinaesthetic, hearing, vision, etc.), and to their emotions, thoughts, and memories, without judgment. Attendees are guided through practices of focused attention while sitting and while moving. MBSR does not have to be conducted by a health care professional in a medical setting, but is best taught by an experienced instructor, and certification processes are in place for this purpose. Mindfulness training for military personnel has been shown to be protective for attentional lapses [4], to prevent increased stress, and maintain working memory capacity [5]. For combined groups of active duty military personnel and veterans, mindfulness training has been shown to reduce Posttraumatic Stress Disorder (PTSD) © Springer International Publishing AG (outside the USA) 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_3

Characteristics of United States Military Personnel and Veterans

23

symptoms, stress, pain level [1], and fatigue [6], while increasing vigor [6]. Mindfulness training also helped reduce anxiety and depression in veterans [7] and improved emotional and physical coping, personal functioning, and stress management [8]. As research with Institutional Review Board approval, the participants in the above mentioned mindfulness studies were volunteers who had the option to terminate their participation at any time. However, little is known about the characteristics of military and veteran participants who complete mindfulness training, compared to those who do not. Understanding this could help mindfulness trainers more effectively identify those likely to complete mindfulness meditation training (and gain greater benefit from the training), and the delivery system that best suits them, while engaging them in the process. Greeson and colleagues examined MBSR training and found 34% of the participants did not complete the post-training survey, and those who completed the post survey had less severe depressive symptoms than at baseline [9]. Online training provides another way for participants to receive mindfulness training, instead of attending in-person. On-line training may increase attendance since it is more flexible for the participants in terms of their physical location during training. In a study on online Mind-Body Skills training, Kemper and colleagues [10] found that 57% of the participants completed the post training survey and the non-completers had lower scores than the completers in perspective-taking, compassion and confidence in providing calm, compassionate care. Finally, researchers have conducted qualitative studies on barriers to participation and acceptability of mindfulness training (why someone discontinues or completes training), however they did not include demographic or survey-based personal characteristics (who ceases or continues training) [11]. No published studies were found that investigated completion rates for mindfulness meditation taught over a Virtual World, or of active duty U.S. military service members and veterans participating in mindfulness training conducted in-person and via a Virtual World. The purpose of this research was to examine the personal characteristics of the military and veteran research volunteers who completed mindfulness training conducted either in-person or through an online Virtual World, compared with those who did not complete the training.

2 Methods 2.1

Participants

Active duty U.S. military service members and veterans were recruited as research volunteers from Joint Base San Antonio, Fort Sam Houston and the surrounding vicinity. Inclusion criteria required volunteers be a U.S. military service member or veteran, understand written and spoken English, and not be experiencing an active psychosis. The study was approved by an Institutional Review Board. Of the total 160 volunteers who signed an informed consent form prior to participation, 78 were assigned to the in-person training group (IP), and 82 to the online Virtual World training group (VW). Volunteers were permitted to withdraw from the research study at their own discretion.

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2.2

B. Liu and V.J. Rice

Questionnaires

Prior to attending mindfulness training, volunteers answered questionnaires on their demographics, mindfulness, and PTSD symptoms. The questionnaires were presented and answered using a laptop and Microsoft Access software. Demographic Questionnaire. The demographic questionnaire included questions on age, race, gender, education level, marital status, military status, and time-in-service. Time-in-service refers to an individual’s total time on active duty, including any prior service time. Mindful Awareness and Attention Scale (MAAS). The MAAS is a self-report questionnaire that measures trait mindfulness indicated by enhanced attention to, and awareness of, present experiences over time [12, 13]. This questionnaire includes 15 items with statements such as, “I break or spill things because of carelessness, not paying attention, or thinking of something else”. Respondents rate how often they have experienced such instances on a 6-point Likert scale (1 = almost always, 2 = very frequently, 3 = somewhat frequently, 4 = somewhat infrequently, 5 = very infrequently, and 6 = almost never). A single average score is generated from the questionnaire. The questionnaire has been shown to be reliable and valid [12]. A test-retest reliability of 0.81 and internal consistency of 0.82 were reported [12], and the assessment has been positively correlated with other measures of mindfulness [14]. Posttraumatic Stress Disorder Checklist – Military Version (PCL-M). The PCL-M is a self-report checklist of PTSD symptoms for military personnel. The PTSD symptoms are based on diagnostic criteria in the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) [15]. The questionnaire addresses the severity of PTSD-related symptoms in response to “stressful military experiences” for 17 items [16, 17]. Three symptom clusters are addressed, including re-experiencing the event, avoiding stimuli related to the event, and hyperarousal. Hyperarousal refers to symptoms of amplified arousal, such as difficulty falling or staying asleep or hypervigilance. Symptoms are rated on a 5-point Likert scale from 1 (not at all) to 5 (extremely). The total score ranges from 17 to 85 and indicates the severity of a person’s PTSD related symptoms. The test-retest reliability of the questionnaire is over 0.96 [18] and the validity is between 0.77 and 0.90 [16]. Each item rated as “moderately” or “above” (responses 3 through 5 on individual items) is considered as a symptom. A presumptive diagnosis of PTSD can be made by following the DSM-IV diagnostic rule that requires a certain number of symptoms from each of the three clusters and using a cut-off score of 35 at the same time. A full diagnosis requires a personal interview with a trained health care provider.

2.3

Procedure

After signing the informed consent form, volunteers completed the pre-intervention questionnaires and participated in a 1-hr introductory session on mindfulness meditation and what to expect during training. All volunteers participated in mindfulness training based on Dr. Kabat-Zinn’s and the University of Massachusetts Center for

Characteristics of United States Military Personnel and Veterans

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Mindfulness MBSR program [3, 19]. Those in the IP group received traditional MBSR training, while those in the VW group received an abbreviated version of MBSR training. Classes for the IP group were conducted in-person, face-to-face with an experienced MBSR instructor in a group setting. The IP group met once a week for approximately 2 h for 8 consecutive weeks, and attended an all-day silent retreat between weeks 5 and 7. The VW group training was conducted by experienced MBSR instructors through a Virtual World called Second Life. The VW participants selected an avatar from secondlife.com and were trained to control their avatar in a Second Life viewer (i.e. Firestorm). Classes were held at pre-determined times and occurred in real time. The VW instruction included 1.5 h classes, once a week for 8 weeks with an additional 3.5 h extended class between weeks 6 and 7. The volunteers were able to take the online training from their home or another quiet place with internet access, at their preference. Volunteers could see their own avatar and the avatars of their instructor and classmates. They could speak through a wireless headset or type messages to classmates and the instructor during classes. Classes for both groups covered the same didactic material, topic areas, and mindfulness meditation practices. Both groups also completed the same homework assignments and practices.

2.4

Statistics

Descriptive analyses included frequencies, means and standard deviations (SD) of the outcome measures, and recorded first for all volunteers and then separately for each of the two groups (IP and VW). The volunteers who took the post-training assessments were considered to have completed the training, otherwise they were considered as not completing the training. T-tests and Chi-square tests were used to explore the differences in demographic information, and the MAAS and PCL-M questionnaire scores between the completers and non-completers within each group. Data analyses were conducted with the IBM SPSS Statistics for Windows (Version 22, Armonk, NY: IBM Corp, Released 2013) using a significance level of .05.

3 Results 3.1

Demographic Information and Questionnaire Results

Volunteers were predominantly veterans (71.9%) with ages ranging from 24 to 74 (Mean = 48.6, SD = 12.1). Participants’ time in service ranged from 1 to 34 years with a mean of 14.8 ± 8.8 years. Over half of the volunteers were males (55%), Caucasian (54.4%), and married (58.1%), and most had attained at least a college or professional degree (71.9%) (see Table 1).

26

B. Liu and V.J. Rice Table 1. Descriptive results of demographic informationa IP group N % Gender Male Female Race African american Native american Caucasian Hispanic Asian Other Marital status Married Divorced Widowed Single/separated Living with significant other Education GED High School Some college Associate degree Bachelor’s degree Master’s degree Doctoral degree Other professional degree Military status Active duty Veteran

VW group N %

Total N

%

44 34

56.4 43.6

44 38

53.7 46.3

88 72

55.0 45.0

17 1 39 19 2 0

21.8 1.3 50.0 24.4 2.6 0

19 1 48 12 1 1

23.2 1.2 58.5 14.6 1.2 1.2

36 2 87 31 3 1

22.5 1.3 54.4 19.4 1.9 0.6

43 16 1 15 3

55.1 20.5 1.3 19.2 3.8

50 15 1 14 2

61.0 18.3 1.2 17.0 2.4

93 31 2 29 5

58.1 19.4 1.3 18.1 3.1

3 4 14 11 20 18 4 4

3.8 5.1 17.9 14.1 25.6 23.1 5.1 5.1

0 6 18 7 23 21 2 5

0 7.3 22.0 8.5 28.0 25.6 2.4 6.1

3 10 32 18 43 39 6 9

1.9 6.3 20.0 11.3 26.9 24.4 3.8 5.6

17 21.8 28 34.1 45 28.1 61 78.2 54 65.9 115 71.9 Mean SD Mean SD Mean SD Age 50.53 12.35 46.84 11.59 48.64 12.07 Time in service 15.23 8.70 14.38 8.89 14.79 8.78 a The total percentage may not be exactly 100 due to rounding, total numbers not equal to 160 are due to missing values.

Just under a third of the participants (29.4%) met the presumptive diagnosis of PTSD based on their PCL-M scores. The total PCL-M score mean was 38.37 ± 18.23. The MAAS scores showed a mean mindfulness score of 3.57 ± 0.94, indicating medium mindfulness. The questionnaire results for all the participants and the two groups separately are shown in Table 2.

Characteristics of United States Military Personnel and Veterans

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Table 2. Number and percent of those with and without presumptive PTSD, means and standard deviations of MASS and PCL-M IP group N PTSD (based on PCL-M) PTSD 24 No PTSD 54 Mean MAAS scores 3.76 PCL-M scores 37.71

3.2

%

VW group N %

30.8 23 69.2 59 SD Mean 0.89 3.40 17.76 39.00

Total N

28.0 47 72.0 113 SD Mean 0.96 3.57 18.75 38.37

% 29.4 70.6 SD 0.94 18.23

Differences Between Volunteers Who Completed the Post-Training Survey and Those Who Did Not

The dropout rates for the IP and VW groups were 36% and 48% respectively (see Table 3), and not significantly different from one another (F(1, 160) = 2.23, p = .14). Table 3. Number of participants who completed or dropped out the training in each group Completed IP 50(64%) VW 43(52%) Total 93(58%)

Did not complete Total 28(36%) 78 39(48%) 82 67(42%) 160

Data from the volunteers in the IP and VW groups were analysed separately, and the characteristics of those who completed the study, versus those who did not complete the study, were identified. For IP group, only gender was found to be different between completers and non-completers. A higher percentage of women (76.5%) than men (54.5%) completed the training (F(1,75) = 4.007, p = .045) (see Table 4). Table 4. The number of participants by gender and by completion of the IP training Completed Did not complete Total Male 24(54.5%) 20(45.5%) 44 Female 26(76.5%) 8(23.5%) 34

For the online VW group, significant differences were found for age, MAAS score, and a presumptive diagnosis of PTSD between participants who completed and those who did not complete training (see Tables 5 and 6). Those who did not complete the training tended to be slightly younger, have lower pre-training MAAS scores, and have a presumptive diagnosis of PTSD.

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B. Liu and V.J. Rice Table 5. Statistics for age and MAAS total score in the VW group Age

Completed Did not complete MAAS total scores Completed Did not complete

N 43 39 43 39

Mean 50.30 43.03 3.6713 3.0940

SD T-test results 10.846 t(80) = 2.974, p = .004 11.303 .95290 t(80) = 2.823, p = .006 .89243

Table 6. Statistics for PTSD based on PCL-M in the VW group PTSD based on PCL-M Completed Did not complete Total No PTSD 35(59.3%) 24(40.7%) 59 With PTSD 8(34.8%) 15(65.2%) 23 F(1,82) = 3.996, p = .046.

4 Discussion In our study 42% of volunteers did not complete mindfulness training and the final surveys. While no previous information could be found regarding the number of personnel and individual characteristics of individuals completing mindfulness training, dropout rates for discontinuation of adult psychotherapy and treatment of PTSD are reported at approximately 20% [20, 21]. However, the differences in the participants and training may explain the inconsistencies between those study results and ours. The volunteers in this study included any U.S. military service members or veterans who met the entrance criteria (their study participants were patients); our mindfulness training was not concentrated on any medical or psychological diagnosis, while their participants had a specific diagnosis; and our volunteers were not referred by a physician or health care professionals. Patients being seen for medical conditions can cease recommended treatments at any time, as can a research volunteer. However, it is likely that patients have more at stake and will continue medical treatment more so than research volunteers. For example, patients may feel they need to show their care providers they are complying with all forms of patient care. On the other hand, research volunteers may participate out of curiosity, for something interesting to do, or to support the Army’s research program, and their dedication to completion may be lower. In addition, approximately 72% of the research volunteers were veterans. During his dissertation on treatment of PTSD, Kurz [22] found that while active duty service members experience greater barriers to initial treatment, veterans have more barriers to continuation of treatment. Finally, some of our research volunteers were assigned elsewhere, deployed during training, or had increases in their mission responsibilities that precluded continued participation. The dropout rates of the IP (36%) and VW (48%) groups were not statistically different from one another, yet they show a larger cessation of participation by those participating in the virtual world. The IP group was conducted face-to-face, and personal characteristics did not seem to impact whether volunteers completed or terminated the training, except more women than men completed training. According to the National

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29

Center for Complementary and Integrative Health (NCCIH) and the National Center for Health Statistics (part of the Centers for Disease Control and Prevention), the use of Complementary and Alternative Medicine use among adults is greater among women than men [23]. Kemper and colleagues found female medical students were more interested in electives on the complementary medicine than males [24]. While our results with the IP group appear to support these findings, there was not a gender difference in the VW group. Another possible explanation may be that women prefer face-to-face communication, yet women have been found to use internet-based mediated communication more often than men [25]. Examining the types of communication and interactions that are preferred in-person versus virtual, both at work and for social connections may reveal that a blended approach is best for telehealth, work, and home use. For the online VW group, the participants who were slightly younger, with a presumptive diagnosis of PTSD, and those who were less mindful before training were more likely to drop out. These findings are counter-intuitive, as it would be expected that younger participants would be more interested in and proficient with on-line media. However, while age was significant, the mean ages of the “younger” and “older” volunteers were 43 and 50 years of age, respectively. Future research investigating the age difference is needed, as our research participants were generally of an older age. There are two reasons for this: (1) individuals of a higher rank are better able to control their own time schedules and arrange to participate in a research study and (2) many of the participating veterans were more senior. Our results showing that participants with a presumptive diagnosis of PTSD are less likely to complete VW mindfulness training supports findings by other researchers. First, many with PTSD do not complete their recommended treatment [26], and may only attend a single appointment [27]. Second, engaging with ones’ provider is important for individuals with PTSD to gain treatment benefits, as noted by Jaycox and Foa [28]. The concept of engagement was also emphasized by Greeson and colleagues, who found participants with more severe depressive symptoms tended to drop out MBSR training [9]. The authors recommended more attention from the instructor, additional contact with the instructor, and individual psychotherapy when the symptoms of depression were severe [9]. In our study, the IP group participated in approximately 23 h of training, while the VW group participated in approximately 15 ½ hrs. of training. Although the participants in the VW group were encouraged to contact their instructor and ask questions outside of class through an on-line group conversation thread, volunteers rarely availed themselves of this offering (less than three occasions). In addition, those attending in-person could ask to speak to the instructor before or after class. Volunteers who left the VW group before completion were less mindful prior to beginning training. Individuals who exhibited greater mindfulness before training revealed greater personal insight by virtue of their answers to questions on the MAAS, even before beginning training in insight meditation. Therefore, they may have experienced less challenge with the process of attending to their own thoughts and memories, along with recognizing and working with the resulting insights that arise during meditation. This paper does not address the reasons behind volunteer’s early cessation of participation. However, an investigation on soldiers who stopped or dropped out of mental

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health services indicated the most common reasons included perceptions of selfsufficiency, not enough time with the health care professional, work interference, concerns about stigma, confidentiality concerns, and the belief that care was ineffective [27]. Suggested future research might include investigating who completes training and why, including: reasons why attendees cease attending; the impact of required versus elective training; in-person versus other forms of online meditation training; other personal characteristics of those who do and do not complete training; and the cost/benefits of customized versus traditional MBSR or other mindfulness training Knowledge of who remains in particular type of training can help providers and attendees select programs and delivery systems that match their probability of success. This information can also assist providers in designing programs that meet the needs their constituents.

5 Limitations The participants who did not complete the post-training survey were counted as dropouts in this study, the duration of their participation was not considered as a factor. Other personal characteristics and conditions not investigated may contribute to the completion of mindfulness training. This study focused on U.S. active duty service members and veterans. Cautions should be taken in applying these results to other populations.

6 Conclusions The overall dropout rate for U.S. active duty and veterans participating in mindfulness meditation training was relatively high, perhaps due to less motivation given volunteers did not have a clinical diagnosis (and attendance was not necessarily recommended by a health care provider), a lack of monetary investment by volunteers, the difficulties associated with learning to meditate and ‘look inside oneself’, and work-related scheduling changes (including deployment). The results suggest that women, those with presumptive PTSD, and those who are less mindful prior to training may receive greater benefit from mindfulness training presented in-person as opposed to training offered online in a virtual world. Acknowledgements. This research was supported in part by the Army Study Program Management Office (ASPMO). Our appreciation is offered to our colleagues Gary L. Boykin Sr., Angela D. Jeter and Rebekah L. Tree. Special thanks to those who participated in this study. Our appreciation is extended to all U.S. service members and veterans. The views expressed in this article are those of the authors and do not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.

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References 1. Rice, V.J., Liu, B., Boykin, G.: Investigating group wellness training in-person and via telehealth in a 3D virtual world. Presented at the Military Health System Research Symposium, Orlando, FL (2016) 2. Jha, A.P., Stanley, E.A., Kiyonaga, A., Wong, L., Gelfand, L.: Examining the protective effects of mindfulness training on working memory capacity and affective experience. Emotion 10(1), 54–64 (2010) 3. Kabat-Zinn, J.: Full Catastrophe Living, Revised Edition: How to Cope with Stress, Pain and Illness Using Mindfulness Meditation. Bantam Books, Hachette, UK (2013) 4. Jha, A.P., Morris, A.B., Drainer-Best, J., Parker, S., Rostrup, N., Stanley, E.A.: Minds “at attention”: mindfulness training curbs attentional lapses in military cohorts. PLoS ONE 10 (2), 1–19 (2015) 5. Stanley, E.A., Jha, A.P.: Mind fitness: Improving operational effectiveness and building warrior resilience. Jt. Force Q. 55(4), 144–151 (2009) 6. Rice, V.J., Liu, B., Boykin, G.: Group-based mindfulness training via virtual world telehealth, as part of a panel Medical Simulation: Filling the Training Gap. In: Proceedings of the 7th International Conference on Applied Human Factors and Ergonomics, Lake Buena Vista, FL (2016) 7. Serpa, S.J., Taylor, S.L., Tillisch, K.: Mindfulness-based stress reduction (MBSR) reduces anxiety, depression, and suicidal ideation in veterans. Med. Care 52(12, S5), S19–S24 (2014) 8. Wisner, B.L., Krugh, M.E., Ausbrooks, A., Russell, A., Chavkin, N.F., Selber, K.: An exploratory study of the benefits of a mindfulness skills group for student veterans. Soc. Work Ment. Health 13(2), 128–144 (2015) 9. Greeson, J.M., Smoski, M.J., Suarez, E.C., Brantley, J.G., Ekblad, A.G., Lynch, T.R., Wolever, R.Q.: Decreased symptoms of depression after mindfulness-based stress reduction: potential moderating effects of religiosity, spirituality, trait mindfulness, sex, and age. J. Altern. Complement. Med. 21(3), 166–174 (2015) 10. Kemper, K.J., Lynn, J., Mahan, J.D.: What is the impact of online training in mind-body skills. J. Evid. Based Complement. Altern. Med. 20(4), 275–282 (2015) 11. Martinez, M.E., Kearney, D.J., Simpson, T., Felleman, B.I., Bernardi, N., Sayre, G.: Challenges to enrollment and participation in mindfulness-based stress reduction among veterans: a qualitative study. J. Altern. Complement. Med. 21(7), 409–421 (2015) 12. Brown, K.W., Ryan, R.M.: The benefits of being present: mindfulness and its role in psychological well-being. J. Pers. Soc. Psychol. 84(4), 822–848 (2003) 13. Brown, K.W.: Letter to Colleague on Mindful Attention Awareness Scale (2008). http:// www.kirkwarrenbrown.vcu.edu/wp-content/scales/MAAS%20trait%20research-ready%20+ %20intro.pdf 14. Baer, R.A., Smith, G.T., Hopkin, J., Krietemeyer, J., Toney, L.: Using self-report assessment methods to explore facets of mindfulness. Assessment 13, 27–45 (2006) 15. American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorder, 4th edn. American Psychiatric Association, Washington DC (1994) 16. Weathers, F.W., Litz, B.T., Herman, D.S., Huska, J.A., Keane, T.M.: The PTSD Checklist (PCL): reliability, validity, and diagnostic utility. In: Annual Convention of the International Society for Traumatic Stress Studies, San Antonio, TX (1993) 17. U.S. Department of Defense: 2014 Demographics: Profile of the Military Community. Office of the Deputy Assistant Secretary of Defense (Military Community and Family Policy). Military One Source (2014)

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18. Wilkins, K.C., Lang, A.J., Norman, S.B.: Synthesis of the psychometric properties of the PTSD checklist (PCL) military, civilian, and specific versions. Depress. Anxiety 28(7), 596– 606 (2011) 19. Stress Reduction Program in University of Massachusetts Center for Mindfulness: MBSR Standards of Practice: Background and Overview Mindfulness-Based Stress Reduction (2014). http://www.umassmed.edu/cfm/stress-reduction/mbsr-standards-of-practice/. Center for Mindfulness in Medicine, Health Care and Society 20. Swift, J.K., Greenberg, R.P.: Premature discontinuation in adult psychotherapy: a meta-analysis. J. Consult. Clin. Psychol. 80(4), 547–559 (2012) 21. Imel, Z.E., Laska, K., Jakupcak, M., Simpson, T.L.: Meta-analysis of dropout in treatments for posttraumatic stress disorder. J. Consult. Clin. Psychol. 81(3), 394–404 (2013) 22. Kurz, J.: Improving Utilization of and Adherence to Treatment for Post-Traumatic Stress Disorder Among US Service Members and Veterans. RAND Corporation, Santa Monica (2015) 23. Barnes, P.M., Bloom B., Nahin, R.L.: Complementary and Alternative Medicine Use Among Adults and Children: United States, 2007. National health statistics reports, 12 (2008) 24. Kemper, K.J., Larrimore, D., Dozier, J., Woods, C.: Electives in complementary medicine: are we preaching to the choir? Explore: J. Sci. Healing 1(6), 453–458 (2005) 25. Kimbrough, A.M., Guadagno, R.E., Muscanell, N.L., Dill, J.: Gender differences in mediated communication: women connect more than do men. Comput. Hum. Behav. 29(3), 896–900 (2013) 26. Burnam, M.A., Meredith, L.S., Tanielian, T., Jaycox, L.H.: Mental health care for Iraq and Afghanistan war veterans. Health Aff. 28(3), 771–782 (2009) 27. Hoge, C.W., Grossman, S.H., Auchterlonie, J.L., Riviere, L.A., Milliken, C.S., Wilk, J.E.: PTSD treatment for soldiers after combat deployment: low utilization of mental health care and reasons for dropout. Psychiatric Services 65(8), 997–1004 (2014) 28. Jaycox, L.H., Foa, E.B.: Obstacles in implementing exposure therapy for PTSD: case discussions and practical solutions. Clin. Psychol. Psychother. 3(3), 176–184 (1996)

Evidence of a Symptom Cluster: The Impact of Mindfulness Meditation on Self-Reported Stress, Fatigue, Pain and Sleep Among U.S. Military Service Members and Veterans Valerie J. Rice1(&) and Paul J. Schroeder2 1

U.S. Army Research Laboratory, Army Medical Department Field Element, Fort Sam Houston, San Antonio, TX, USA [email protected] 2 DCS Corp, Alexandria, VA, USA [email protected]

Abstract. Physical and behavioral symptoms of stress may occur in a consistent constellation of symptoms. The purpose of this study was to examine the impact of mindfulness meditation (MM) training on U.S. military service members and veterans’ self-reported stress, fatigue, pain, and sleep disturbances, and to investigate whether changes in the outcome measures were uniform or independent of one another. Participants attended 8-weeks of MM training and completed the following pre/post evaluations: Perceived Stress Scale, Patient Health Questionnaire, Pittsburgh Sleep Quality Index. Data were separately analyzed for those experiencing pain at any level and for those experiencing high pain. Scores on each measure were significantly correlated at both measurement occasions (p < .05) and did not differ significantly across training (p > .05), suggesting that MM-related effects on the relationship between the four measures were congruent. These results suggest a symptom cluster, independent of self-reported pain level. Keywords: Mindfulness Pain
Sleep


Meditation
Symptom cluster
Stress
Military


1 Introduction A symptom cluster is a consistent grouping of simultaneously occurring health symptoms that are related to one another, but independent of other symptoms [1]. Items in a symptom cluster may share covariance, a mutual etiology, or a common impact on patient outcomes [2, 3]. Historical methods for identifying symptom clusters include expert opinion, determining if change in one symptom is associated with a similar change in another (increase or decrease) [4], demonstration of shared variance [5], and showing that specific symptoms are correlated with one another [6]. Still other methods for detecting symptom clusters include factor analysis, which allows for the identification of underlying processes possibly accounting for the correlations between variables, mediation analysis [7], and cluster analysis [8] with a pre-set criteria for © Springer International Publishing AG (outside the USA) 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_4

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symptom correlations. Knowledge about symptom clusters allows clinicians to effectively manage integrated interventions for injuries, illnesses, or difficulties around which such clusters exist. Moreover, the presence of a symptom cluster may explain treatment outcomes. For example, the number and severity of symptoms within the cluster may impact outcomes, such as functional status or improvements over time, in a way that the original diagnosis did not. Research on symptoms with cancer patients have revealed that fatigue, insomnia, pain, and depression show evidence of symptom clustering [1, 7, 9], and symptom clusters have been examined for other illnesses and injuries including Post-Traumatic Stress Disorder [10, 11], HIV [12], and multiple sclerosis [13]. In addition, interventions have been evaluated as management tools for clusters of symptoms [14, 15]. Using a symptom cluster approach, Lengacher et al. [17] reported significant reductions in breast cancer survivors self-reported fatigue and disturbed sleep (both elements of a shared fatigue symptom cluster) relative to a control group following a 6-week Mindfulness-based Stress Reduction (MBSR) training program. The authors reported that, although pain and distress loaded on a different symptom cluster (cognitive/psychological cluster), no significant differences were found within that cluster following MBSR training. A study in our laboratory on Mindfulness Meditation (MM) offered an opportunity to examine symptom clusters surrounding pain. The demands associated with U.S. military service, such as exposure to battle, injuries and death, can be extremely challenging, resulting in symptoms similar to those in cancer-based symptom clustering, such as high levels of stress, sleep disorders, pain, and fatigue. Mindfulness meditation training [16] focuses on heightening awareness of participant’s physical, cognitive, and emotional states, as well as the circumstances and events they are experiencing in the present moment. MM/teaches participants to recognize their own state-of-being and their reactions to their internal and external environment, without judgement. With practice, participants learn to recognize their own response patterns and respond deliberately, instead of ‘mindlessly reacting’. Pre/post studies of mindfulness training have found reductions in stress [18–21], pain [19, 20, 22], and fatigue [18, 21], and improvements in sleep [18]. In the present study, we investigated a possible cluster of symptoms (stress, fatigue, pain, and sleep) in active duty military and veterans prior to and following MM instruction by examining the shared variance of bivariate correlations between specific symptoms. Should a cluster of symptoms exist, the relationship between the symptom measures should remain constant in the two assessments (pre- and post-training). On the other hand, if MM training promotes independent changes in self-reported states, then associations between the measures should differ significantly between pre- and post-testing sessions. We also investigated the presence of a clustering of symptoms by examining whether change in one symptom was associated with change in another symptom. If the symptom cluster perspective is correct, then changes in one symptom should be accompanied by concurrent shifts in the other symptoms. For example, if participants report lower perceived stress following MM training, they should likewise report lower fatigue, pain, and stress.

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2 Methods 2.1

Participants

U.S. military active duty service members and veterans (n = 101) were recruited as research volunteers from Joint Base San Antonio and the surrounding vicinity. Volunteers were recruited for a larger study focusing on the effectiveness of MM training offered in-person and over a virtual world. The study was approved by an Institutional Review Board and research volunteers read and completed an informed consent form prior to participation. Participants were not compensated for their participation.

2.2

Instruments

Demographic Survey: The demographic survey included questions about participants’ age, race/ethnicity, gender, education, marital status, military status, military branch, deployment (i.e. whether they had deployed), and time-in-service (the amount of time the respondent was in the military). Participants answered the questions using a computerized questionnaire created with Microsoft Access. Perceived Stress Scale (PSS): The PSS is a 10-item instrument that uses a five-point Likert response scale (0 = never, 1 = Almost Always, 2 = Sometimes, 3 = Fairly Often 4 = Very Often) to quantify respondents stress levels. It also gives potential insight into the factors contributing to the respondent’s experience of stress [23, 24]. Patient Health Care Questionnaire (PHQ15): The PHQ15 is a somatic symptom subscale derived from the full PHQ. It is a self-administered version of the PRIME-MD diagnostic instrument [25]. The PHQ15 includes 14 of the 15 most prevalent DSM-IV somatization disorder somatic symptoms [25] and is rated on a three point scale (0 = not bothered at all; 1 = bothered a little; 2 = bothered a lot). The questionnaire asks participants to rate the extent to which they have experienced somatic symptoms “during the past 4 weeks” [25]. For the current study, responses to item 14 (“Feeling tired or having low energy”) served as a measure of self-reported fatigue and the sum total of responses to items one – six (“stomach pain”, “back pain”, pain in your arms, legs or joints”, “menstrual cramps”, “headaches”, and “chest pain”) served as a measure of self-reported pain. Pittsburgh Sleep Quality Index (PSQI): The PSQI is a self-rated sleep questionnaire that assesses sleep quality and disturbances over a 1-month time interval [26]. The 10-item questionnaire generates one global score and seven component scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction [26].

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2.3

V.J. Rice and P.J. Schroeder

Procedure

After completing the informed consent form, volunteers were assigned to either a training group or a control group (control data are not presented in this paper). Pre- and post-training evaluations included the outcome measures listed above, along with other subjective and objective measures – to be reported in follow-on papers. Those receiving MM training completed training in one of two ways, either receiving traditional in-person Mindfulness-Based Stress Reduction training or an abbreviated version of the training offered over the Virtual World of Second Life. The training was identical in terms of topics for discussion, meditation practices and homework; but differed in length of time per class (In-person = *2 to 2½ h per class with a 7 h. silent retreat between classes 5 and 7, Virtual World = 1½ h per class with a 3 h. silent retreat between classes 5 and 7). Training classes were taught by experienced, trained MM instructors. For the purposes of this analysis, both training groups were consolidated into one group. A/wait-list control group (not included in the present analyses) received no MM training.

2.4

Statistics

Data analyses were conducted with the IBM SPSS Statistics for Windows (Version 21, Armonk, NY: IBM Corp, Released 2012). Descriptive statistics and frequency analyses were used to analyze the demographic data. Dependent-samples T-Test were used to examine mean differences in stress, fatigue, pain, and sleep disturbance scores. Pearson Product Moment correlations were used to examine the relationships between stress, fatigue, pain, and sleep disturbance scores. A p-value of 0.05 was used to determine significance. Significance testing of pre- and post-training correlation coefficients were conducted using COCOR (www. Comparingcorrelations.org) developed by Diedenhofen and Musch [27]. Briefly, significance testing for dependent correlations compares two correlation coefficients obtained from the same sample to establish if they are statistically similar or different from one another. The z-score values were obtained from COCOR’s output of a modification of Dunn and Clark’s z (1969) [28] using a back-transformed average z procedure. It should be noted that some volunteers self-reported pain fell below the median score for all participants (4.00) during initial (pre-training) assessments. In order to determine if MM training had a beneficial effect on the symptom cluster for those that self-reported higher levels of pain, a second, separate set of analyses were conducted on the pre/post-training stress, fatigue, pain, and sleep disturbance scores of a subset of people from the original sample that met or exceeded the median pain rating for all volunteers.

3 Results Data from six volunteers (8.9%) were omitted from the final analysis because their pain rating was zero (i.e., no self-reported pain). The final total number of volunteers was 94.

Evidence of a Symptom Cluster: The Impact of Mindfulness

3.1

Volunteer Demographics

Analysis of the demographics of the volunteers are shown in Table 1. Table 1. Frequency distribution of participant demographics. Age (years) Gender Male Female Race African American Native American Caucasian Hispanic Asian Other Education GED/High school Some college/AA Bachelor’s degree MA/Ph.D. Other Marital status Married Divorced Widowed Single/Separated Partnered with sig other Self-reported health rating (5 points max) Military service Active service members Veteran service members Time in service (years) Years since deployment Months deployed Deployed in harm’s way 0 1 time 2 times 3 times 4 times 5 + times

Mean/# % 50.96 – 49 45

52.1 47.9

19 2 54 16 2 1

20.2 2.1 57.4 17.0 2.1 1.1

7 28 24 31 4

7.4 29.8 25.5 33.0 4.3

58 15 1 17 3 3.37

67.1 16.0 1.1 18.1 3.2 –

24 70 15.72 13.82 9.29

25.5 74.5 – – –

22 27 6 7 3 3

32.4 39.7 8.8 10.3 4.4 4.4

37

38

3.2

V.J. Rice and P.J. Schroeder

Results with All Volunteers

Correlational analyses of volunteers pre-and post-MM training scores (Tables 2 and 3) showed significant positive relationships between the measures. Table 2. Pearson correlations among the measures (pre-MM Training). PSS Fatigue Pain PSS 1 .54** .47** Fatigue 1 .49** Pain 1 Sleep disturbance PSS = Perceived Stress Scale. **p < .01

Sleep disturbance .42** .44** .47** 1

Table 3. Pearson correlations among the measures (post-MM Training). PSS Fatigue Pain Sleep disturbance PSS 1 .54** .52** .44** Fatigue 1 .56** .49** Pain 1 .40** Sleep disturbance 1 PSS = Perceived Stress Scale. **p < .01, *p < .05

As shown in Table 4, statistically significant differences were found in volunteer’s pre- and post- MM training stress, fatigue, and sleep disturbance scores. Table 4. Means, standard deviations, n’s, and paired t-test results for the four measures between testing sessions. Pre-MM Post-MM training n Mean SD n Mean SD PSS 94 19.31 7.76 86 16.49 7.53 Fatigue 94 1.41 .68 86 1.15 .73 Pain 94 4.45 2.37 93 4.04 2.82 Sleep disturbance 93 1.71 .64 70 1.09 .79 PSS = Perceived Stress Scale. a Post- MM Training PSS scores were missing for eight volunteers.

t

df

sig.

4.200 3.531 1.651 5.850

85a 85 92 69

.0001 .001 .102 .0001

Evidence of a Symptom Cluster: The Impact of Mindfulness

39

Table 5 presents the z-score values obtained from COCOR’s output. Pre- and posttraining correlations between the stress, fatigue, pain, and sleep disturbance measures did not differ significantly, suggesting that changes in the relationship between the measures were uniform across conditions. Because the significance test requires the pre and post sample matches, only those individuals who completed the study were included in this analysis.

Table 5. Z-score values for the significance test for the dependent correlations. PSS Fatigue Pain 1 .000 −.6610 1 −.9504 1

PSS Fatigue Pain Sleep disturbance PSS = Perceived Stress Scale.

3.3

Sleep disturbance −.1837 −.4730 .6459 1

Results with Volunteers Who Self-Reported Pain Above the Median Level of All Participants

It should be noted that 37.23% (n = 35) of volunteers self-reported pain below the median score for all participants (4.00) during initial (pre-training) assessments. In order to determine if MM training had a beneficial effect on the symptom cluster for those who self-reported higher levels of pain, a separate set of analyses were conducted on the pre/post training stress, fatigue, pain, and sleep disturbance scores of a subset of people from the original sample that met or exceeded the median pain rating for all volunteers (n = 59, 62.77%). Table 6. Pearson correlations among the measures (pre-MM Training) for volunteers that reported pain greater than the median threshold. Measure PSS Fatigue PSS 1 .45** Fatigue 1 Pain Sleep disturbance PSS = Perceived Stress Scale. **p < .01, *p < .05

Pain .50** .40** 1

Sleep disturbance .30* .20 .36** 1

As with Tables 2, 3, 6, and 7 show significant positive correlations between the scores on the measures before and to a greater extent following MM training. As can be seen in Table 8, outcomes from the first set of analyses were replicated and extended, to the extent that there were significantly lower levels of self-reported perceived stress, fatigue, and sleep disturbances, as well as a nearly significant trend towards lower levels of self-reported pain following MM training. Mean post-training self-reported pain scores were .67 points lower than pre-training scores.

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Table 7. Pearson correlations among the measures (post- MM Training) for volunteers that reported pain greater than the median threshold. Measure PSS Fatigue PSS 1 .59** Fatigue 1 Pain Sleep disturbance PSS = Perceived Stress Scale. **p < .01, *p < .05

Pain .46** .48** 1

Sleep disturbance .43** .44** .38* 1

Table 8. Mean’s, standard deviations, and paired t-test results for the four measures between training sessions for volunteers that reported pain greater than the median threshold. Measure

Pre-MM training n Mean SD PSS 59 21.20 6.74 Fatigue 59 1.59 .56 Pain 59 5.83 1.82 Sleep disturbance 58 1.86 .61 PSS = Perceived Stress Scale.

Post-MM training n Mean SD 54 18.94 7.25 54 1.33 .70 58 5.16 2.69 41 1.22 .82

t

df

sig

2.462 2.574 2.002 4.068

53 53 57 40

.017 .013 .050 .000

Significance Testing of Pre- and Post- Mindfulness Training Correlation Coefficients. As with our previous analyses, pre- and post-training correlation coefficients were compared to determine if they differed significantly. No significant differences were observed, suggesting that training-related changes in the relationship between the measures were uniform (Table 9).

Table 9. Z-score values for the significance test for the dependent correlations for volunteers that reported pain greater than the median threshold. Measure PSS Fatigue PSS 1 −1.2566 Fatigue 1 Pain Sleep disturbance PSS = Perceived Stress Scale.

Pain .3269 −.6331 1

Sleep disturbance −.8602 −1.9569 −.1236 1

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41

4 Discussion In the present study we compared self-reported stress, fatigue, pain, and sleep disturbances among active and veteran U.S. Military service members that reported experiencing pain before and after completing an eight week MM training program. Preliminary analyses revealed significant differences in the volunteer’s self-reported state scores with higher pre- training scores relative to post-training scores, except for pain. However, subsequent analyses with individuals that reported higher levels of pain replicated and extended our initial analyses by showing a marginally significant trend toward lower pain following MM training. In addition, significant associations were found between pre- and post-training scores on the measures. Further testing showed that the pre-training correlations did not differ significantly from post-training correlations. Collectively, these findings appear to support the notion of a symptom cluster among service members that report experiencing pain. MM training prompted marked improvement in volunteers’ self-reported stress, fatigue, and sleep disturbances. This finding is consistent with previous research that has shown the beneficial effects of mindfulness meditation training in both military and non-military samples [16, 18, 19]. More recently Serpa et al. [29] reported that MBSR training promoted improvement in military veteran’s anxiety, depression, and suicidal idealization, but not experienced pain. Our results mirror those findings, to the extent that lower levels of self-reported pain were observed from pre- to post- testing, but statistical significance was not reached. Nevertheless, it should be noted that whereas the Serpa et al. [29] study included only veterans, the current sample included both active and veteran service members who self-reported experiencing pain (as measured by the PHQ scale). Prior research in both clinical and non-clinical samples supports the presence of a symptom cluster of fatigue, pain, sleep, and psychological states [1, 6, 30]. In the present study, we found pre- to post- changes after MM training in self-rated stress, fatigue, sleep, but not for pain among the entire volunteer population. For those experiencing higher levels of self-reported pain, reductions in stress, fatigue, sleep and pain (marginally at .05) were seen following mindfulness training. These findings demonstrate that a cluster exists between stress, fatigue and sleep, separate from pain; however when pain is high the symptom cluster appears to include pain. Stress, fatigue, sleep and pain influence one another. For example, high stress can be accompanied by constricted muscles, pain, and insomnia, and pain can produce fatigue. Sleep impairments predict both new episodes of pain, as well as exacerbations of pain [31], sleep disturbances are present in 67–88% of chronic pain disorders [32], and 50% of those with insomnia also reporting chronic pain [33]. However, the directionality (which comes first, stress, sleep, or pain?) and the mechanisms of association remain in question.

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5 Limitations One limitation of the current study is that it did not include direct measures of pain and fatigue. Instead, items from the Patient Health Questionnaire that queried about fatigue and pain were used. Future researchers are encouraged to use other measures of pain and fatigue. A second limitation is the study population, U.S. military service members and veterans who self-reported pain. Care should be taken in generalizing these results to other populations.

6 Conclusions This research demonstrated a symptom cluster between stress, fatigue, sleep and marginally – pain, independent of a specific clinical diagnosis. One advantage of MM training over other treatment approaches is that it enhances multiple facets of well-being (e.g., stress, fatigue, pain, and sleep), rather than individual complaints (e.g., stress-only). This is important when the source of a health issue is vague or difficult to isolate. Future studies could explore the application of MM training in treating chronic health conditions that involve symptom clusters. Acknowledgements. Special thanks to the U.S. military service members and veterans who participated in this study. This research was supported in part by the U.S. Army Study Program Management Office (ASPMO). Our appreciation is offered to our colleagues Mr. Gary Boykin, Dr. Baoxia Liu, Ms. Angela Jeter, Ms. Jessica Villarreal, and Mr. Jim Hewson. The views expressed in this article are those of the authors and do not reflect the official policy or position of the Department of the Army, Department of Defense, or the U.S. Government.

References 1. Kim, H.J., McGuire, D.B., Tulman, L., Barsevick, A.M.: Symptom clusters: concept analysis and clinical implications for cancer nursing. Cancer Nurs. 28, 283–284 (2005) 2. Dodd, M., Janson, S., Facione, N., Faucett, J., Froelicher, E.S., Humphreys, J., Lee, K., Miaskowski, C., Puntillo, K., Rankin, S., Taylor, D.: Advancing the science of symptom management. J. Adv. Nurs. 33, 668–676 (2001) 3. Miaskowski, C., Dodd, M., Lee, K.: Symptom clusters: the new frontier in symptom management research. J. Natl. Cancer Inst. Monogr. 32, 17–21 (2004) 4. Beck, S.L., Dudley, W.N., Barsevick, A.: Pain, sleep disturbance, and fatigue in patients with cancer: using a mediation model to test the symptom cluster. Oncol. Nurs. Forum 32, E48–E55 (2005) 5. Miaskowski, C., Cooper, B.A., Paul, S.M., Dodd, M., Lee, K., Aouizerat, B.E., West, C., Cho, M., Bank, A.: Subgroups of patients with cancer with different symptom experiences and quality-of-life outcomes: a cluster analysis. Oncol. Nurs. Forum 33, E79–E89 (2006) 6. Barsevick, A.M.: The elusive concept of the symptom cluster. Oncol. Nurs. Forum 34, 971– 980 (2007) 7. Barsevick, A.M., Dudley, W.N., Beck, S.L.: Cancer-related fatigue, depressive symptoms, and functional status: a mediation model. Nurs. Res. 55, 366–372 (2006)

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8. Parker, K.P., Kimble, L.P., Dunbar, S.B., Clark, P.C.: Symptom interactions as mechanisms underlying symptom pairs and clusters. J. Nurs. Scholarsh. 37, 209–215 (2005) 9. Chen, M.L., Lin, C.C.: Cancer symptom clusters: a validation study. J. Pain Symptom Manage 34, 590–599 (2007) 10. Lynch, J.H., Mulvaney, S.W., Kim, E.H., deLeeuw, J.B., Schroeder, M.J., Kane, S.F.: Effect of stellate ganglion block on specific symptom clusters for treatment of post-traumatic stress disorder. Mil. Med. 181, 1135–1141 (2016) 11. Tursich, M., Ros, T., Frewen, P.A., Kluetsch, R.C., Calhoun, V.D., Lanius, R.A.: Distinct intrinsic network connectivity patterns of post-traumatic stress disorder symptom clusters. Acta Psychiatr. Scand. 132, 29–38 (2015) 12. Moens, K., Siegert, R.J., Taylor, S., Namisango, E., Harding, R.: Symptom clusters in people living with HIV attending five palliative care facilities in two sub-Saharan African countries: a hierarchical cluster analysis. PLoS ONE 10, 1–12 (2015) 13. Shahrbanian, S., Duquette, P., Kuspinar, A., Mayo, N.E.: Contribution of symptom clusters to multiple sclerosis consequences. Qual. Life Res. 24, 617–629 (2015) 14. Charalambous, A., Giannakopoulou, M., Bozas, E., Marcou, Y., Kitsios, P., Pailousis, L.: Guided imagery and progressive muscle relation as a cluster of symptoms management intervention in patients receiving chemotherapy: a randomized control trial. PLoS ONE 11, 1–18 (2016) 15. Reich, R.R., Lengacher, C.A., Alinat, C.B., Kip, K.E., Paterson, C., Ramesar, S., Han, H.S., Ismail-Khan, R., Johnson-Mallard, V., Moscoso, M., Budhrani-Shani, P., Shivers, S., Cox, C.E., Goodman, M., Park, J.: Mindfulness-based stress reduction in post-treatment breast cancer patients: immediate and sustained effects across multiple symptom clusters. J. Pain Symptom Manage. 53, 85–95 (2017) 16. Kabat-Zinn, J., Massion, A.O., Kristeller, J., Peterson, L.G., Fletcher, K.E., Pbert, L., Lenderking, W.R., Santorelli, S.F.: Effectiveness of a meditation-based stress reduction program in the treatment of anxiety disorders. Am. J. Psychiatry 149, 936–943 (1992) 17. Lengacher, C.A., Reich, R.R., Post-White, J., Moscoso, M., Shelton, M.M., Barta, M., Le, N., Budhrani, P.: Mindfulness based stress reduction in post-treatment breast cancer patients: an examination of symptoms and symptom clusters. J. Behav. Med. 35, 86–94 (2012) 18. Carlson, L.E., Garland, S.N.: Impact of mindfulness-based stress reduction on sleep, mood, stress, and fatigue symptoms in cancer outpatients. Int. J. Behav. Med. 12, 278–285 (2005) 19. Carmody, J., Baer, R.A.: Relationships between mindfulness practice and levels of mindfulness, medical and psychological symptoms and well-being in a mindfulness-based stress reduction program. J. Behav. Med. 31, 23–33 (2008) 20. Rice, V.J., Liu, B., Boykin, G.: Group-based mindfulness training via virtual world telehealth: filling the training gap. In: 7th International Conference on Applied Human Factors and Ergonomics. Springer, Berlin (2016) 21. Rice, V.J., Liu, B., Boykin. G.: Investigating group wellness training in-person and via telehealth in a 3D virtual world. Presented at the Military Health System Research Symposium, Orlando, FL (2016) 22. Reiner, K., Granot, M., Soffer, E., Lipsitz, J.D.: A brief mindfulness meditation training increases pain threshold and accelerated modulation of response to tonic pain in an experimental study. Pain Med. 4, 628–635 (2016) 23. Cohen, S., Kamarck, T., Mermelstein, R.: A global measure of perceived stress. J. Health Soc. Behav. 24, 385–396 (1983) 24. Cohen, S., Williams, G.: Perceived stress in a probability sample of the United States. In: Spacapan, S., Oskamp, S. (eds.) The Social Psychology of Health: Claremont Symposium on Applied Social Psychology, pp. 31–67. Sage, Newbury Park, CA (1998)

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25. Kroenke, K., Spitzer, R.L., Williams, B.W.: The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom. Med. 64, 258–266 (2002) 26. Buysse, D.J., Reynolds III, C.F., Monk, T.H., Berman, S.R., Kupfer, D.J.: The pittsburgh sleep quality index: a new instrument for psychiatric practice and research. Psychiatry Res. 28, 193–213 (1989) 27. Diedenhofen, B., Musch, J.: COCOR: a comprehensive solution for the statistical comparison of correlations. PLoS ONE 10, e0131499 (2015) 28. Hittner, J.B., May, K., Silver, N.C.: A monte carlo evaluation of tests for comparing dependent correlations. J. Gen. Psychol. 130, 149–168 (2003) 29. Serpa, J.G., Taylor, S.L., Tillisch, K.: Mindfulness based stress reduction (MBSR) reduces anxiety, depression, and suicidal ideation in veterans. Med. Care 52, S19–S24 (2014) 30. Nicassion, P.M., Moxham, E.G., Schuman, C.E., Gevirtz, R.N.: The contribution of pain, reported sleep quality, and depressive symptoms to fatigue in fibromyalgia. Pain 100, 271–279 (2002) 31. Finan, P.H., Goodin, B.R., Smith, M.T.: The association of sleep and pain: an update and path forward. J. Pain 14, 1539–1552 (2013) 32. Morin, C.M., LeBlanc, M., Daley, M., Gregoire, J.P., Merette, C.: Epidemiology of insomnia: prevalence, self-help treatments, consultations, and determinants of help-seeking behaviors. Sleep Med. 7, 123–130 (2006) 33. Smith, M.T., Haythornthwaite, J.A.: How do sleep disturbance and chronic pain inter-relate? Insights from the longitudinal and cognitive-behavioral clinical trials literature. Sleep Med. Rev. 8, 119–132 (2004)

Evaluation of Effect on Cognition Response to Time Pressure by Using EEG Shyh-Yueh Cheng ✉ (

)

Department of Occupational Safety and Health, Chia-Nan University of Pharmacy and Science, Tainan 717, Taiwan, ROC [email protected]

Abstract. In our competition society, people have to compete with time. Either official business at workplace or private business at home, to face the stress is become a part of our lives. The purpose of this study is to explore the effect on cognition response on time pressure. By using EEG, two sessions of experimental tasks with different response times including 9 s (long term) and 5 s (short term) for responding mental arithmetic were used to serve as two time pressure condi‐ tions. Twenty college students aged from twenty to twenty-eight years old recruited for subjects participated the experiment testing. Before experiment the subjects must fill in NASA-TLX rating scale and undertook their electroence‐ phalography (EEG) measured. The EEG data including event related potential (ERP) and indices of EEG power spectrum reflected respectively the recognition depth and arousal level were used to evaluate the recognition response. Before mental arithmetic tasks, the participants were measured their EEGs and NASATLX rating scales. Two sessions of mental arithmetic tasks were performed in counterbalance and the EEGs were measured at the same time during the exper‐ imental test. After each session, the participants undertook the flanker tasks to measure their ERP and filled in NASA-TLX rating scales. The results showed the EEG power ratio index β/α were increased, that is, the arousal level arose during mental arithmetic tasks. But there was no significant difference between long term and short term sessions at EEG power indices. For P300 components of ERP, the latency for long term of mental arithmetic task was shorter than that for short term, and the amplitude for long term of mental arithmetic task was higher than that for short term. It manifested that the participants had better treatment for long term of mental arithmetic task. For NASA-TLX rating scales measurement, the participants felt more pressure for short term of mental arithmetic task than that for long term. The study found the participants revealed higher mental workload and deteriorated recognition response under higher time pressure. Keywords: Time pressure · Electroencephalography (EEG) · Event-Related Potential (ERP) · Cognitive response

© Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_5

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Introduction

In our competition society, what we concern is efficiency. Life step becomes faster gradually. Either official business at workplace or private business at home, to face the stress is become a part of our lives. Stress, especially mental stress may result in bother of anxiety and emotionality. Mental stress from workplace would cause physical and mental harm, even increase the probability of the accident. Lin and Hwang (1992) addressed workers’ physical and mental stresses usually arise from the task demands at workplace. As the performance of the worker could not consist with the request of the tasks, the workplace would bring stress to him. The stress employee encounter at work‐ place may essentially endanger his health, moreover, induce the human error causing an accident. The research reported there was 70%–90% system failure resulted from directly or indirectly human error due to the work stress (Lin and Hwang 1992). Thus it is important to develop a system to monitor mental stress to prevent potential accidents. Among current available functional neural imaging approaches, Electroen‐ cephalography (EEG) is non-invasive, portable method to evaluate the mental processing. The advantage of EEG is their high temporal resolution. The temporal reso‐ lution of EEG can be as high as milliseconds and with comparable inexpensive and portable modality. Electroencephalography (EEG) contains spontaneous brain activity and event related potential. Brain oscillations are the interaction of neuronal networks within the brain including various frequencies (Fisch 1991). Delta (δ) band is the frequency range up to 4 Hz and it happens in a deep sleep state. Theta (θ) band present the spectral power value of 4 to 8 Hz and alpha (α) band is the power spectrum of 8 to 13 Hz. Beta (β) is the frequency range from 13 to 20 Hz. Study showed that with the increasing workload, the θ activity increased in the frontal lobe and alpha activity decreased in the occipital lobe (Holm et al. 2009). The event-related potential (ERP) is a transient series of voltage oscillations in the brain recorded from scalp EEG following a discrete event. This ERP component has been found to reflect the further processing of relevant information (i.e. stimuli that require a response) (Lange et al. 1998; Okita et al. 1985; Wijers et al. 1989a, b). In the stimulus-locked ERP, the P300 was defined as the most positive peak in a window between 200 and 500 ms (Ullsperger et al. 1986, 1988). The P300 component is useful to identify the depth of cognitive information processing. It has been reported that the P300 amplitude elicited by mental task loading decreases with the increase in the perceptual/cognitive difficulty of the task (Donchin 1979; Isreal et al. 1980a, b; Kramer et al. 1983, 1985; Mangun and Hillyard 1987; Ullsperger et al. 1986, 1988). On the other hand, P300 showed decreased in amplitude and increased in latency. The aim of this study is to explore the effect on cognition response indifferent levels of time pressure by using EEG.

Evaluation of Effect on Cognition Response

2

47

Method

2.1 Subjects Twenty university students including 10 males and 10 females with age from 18 to 28 participated as volunteer subjects. They had normal hearing and normal or correctedto-normal vision. Each participant met all the inclusion criteria: no medical, psychiatric, or head injury, and not using any medications or drugs. An informed written consent form was obtained from all the participants after the procedure of the study was explained and the laboratory facilities were introduced to them. They were paid for their participation in the study. 2.2 Experimental Protocol The subjects were required to record the EEG before starting the experimental session. Following the EEG measured at rest condition for 5 min, the self-report assessments of task loading were obtained using the NASA-Task Load Index (TLX) rating scale (Hart and Staveland 1988). To acquire the ERP, the subject performed a modified Eriksen flanker task with word stimuli replaced by arrow stimuli (Eriksen and Eriksen 1974) for 5 min. After the measurement of the ERPs had been finished, the subject conducted an experiment task. There were three level of time pressure for the experiment tasks, with 9, 6, and 5 s to response the mental arithmetic as three levels of time pressure, as task 1, 2, and 3 individually. The level of time pressure showed randomly. In the experiment tasks, every subject was asked to mentally add two three-digit numbers for three sessions, each with 15 min, presenting on the black screen and type down answers. Similar EEG recordings were conducted immediately after the completion of each level of experiment task. 2.3 EEG Data Collection During the task performance, EEG was recorded using an electrode cap (Quick-Cap, Compumedics NeuroScan, El Paso, Tex) with Ag/AgCl electrodes placed at the same electrodes with the NIRS measuring used with an electronically linked mastoids refer‐ ence. Two Ag/AgCl electrodes 2 cm above and 2 cm below the left eye recorded vertical electrooculogram (EOG), and 2 electrodes 1 cm external to the outer canthus of each eye recorded horizontal EOG. A ground electrode was placed on the forehead. Electrode impedances were kept below 10 kΩ. The EEG and EOG were amplified by SYNAMPS amplifiers (Neuroscan, Inc.) and sampled at 500 Hz. The EEG epochs were then corrected by eye movement by using the Ocular Artifact Reduction (Semlitsch et al. 1986) command of SCAN 4.3 (Neuroscan, Inc.) and then underwent movement-artifact detection by using the Artifact Rejection command.

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2.4 Event-Related Potentials The latency of each ERP component was defined as the time between the onset of the arrow array from modified Eriksen flanker task and the time when the peak value appeared for stimulus-locked ERP. The amplitude and latency measures for P300 were derived from the stimulus-locked ERP recorded at F3, F4, O1, and O2 electrodes, respectively. It is noted that the EEG epochs of the trials with omitted responses or with reaction times longer or shorter than twice the value of the standard deviation for reaction time were not included in the stimulus-locked ERP.

3

Results

3.1 EEG Measurement The EEG basic indices θ and α at all recording sites (especially O2) presented to increase and decrease respectively, as depicted in Fig. 1(a) and (b), with the level of time pressure. The index β tended to increase from time pressure level 1 to level 2, while decrease from time pressure level 2 to level 3. It demonstrated that the subjects failed to relax and got more tired, appeared less concentrated as faced high level of time pressure. 3.2 ERP Analysis The P300 amplitude at all recording site tended to increase from time pressure level 1 to level 2, while presented significantly decreasing from time pressure level 2 to level 3 (especially at O1). The similar tendency was found in P300 amplitude. It revealed that the subjects undertook the tasks under time pressure would decrease the cognitive response. This phenomenon revealed a decreased depth of cognitive information processing and a decreased level of attention (Fig. 2).

Evaluation of Effect on Cognition Response

49

Theta band 0.5

basic index

0.45 0.4

O1 O2

0.35 0.3

*

0.25 task 1

task 2

task 3

(a)

*

Alpha band

0.48

basic index

0.46 0.44 0.42 0.4

O1 O2

0.38 0.36 0.34 0.32 0.3

task 1

task 2

task 3

(b) Beta band

*

0.2

basic index

0.18 0.16

O1

0.14

O2

0.12 0.1 task 1

task 2

task 3

(c) Fig. 1. Comparison of EEG basic indices of theta (a), alpha (b), and beta (c) in occipital lobe under different time pressure levels. (*: P < 0.05)

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P300 amplitude

uV

*

8.4 8.3 8.2 8.1 8 7.9 7.8 7.7 7.6 7.5 7.4 7.3

O1 O2

task 1

task 2

task 3

(a)

P300 latency

*

350 340 330 ms

320 310

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300

O2

290 280 270 task 1

task 2

task 3

(b) Fig. 2. Comparison of P300 amplitude (a) and latency (b) in occipital region under different time pressure level. (*: P < 0.05)

3.3 NASA Task Load Rating Scale NASA-Task Load Index (TLX) rating scales in the 3 mental arithmetic tasks showed no significant differences. It manifested that subjective assessment by using question‐ naire is not sensitive for mental pressure.

4

Discussion and Conclusion

This study showed that with the increase of time pressure, the activity of brain would decrease. It showed that with the increasing of time pressure, the control of blood vessel of brain would decrease. The results implied that the activities of brain were significantly

Evaluation of Effect on Cognition Response

51

decreased with the increasing time pressure. On the other hand, EEG recordings found that the subjects failed to relax and got more tired, appeared less concentrated as faced high level of time pressure. This indicated that if the time pressure is too high, the cortical activation would decrease. Both measurements demonstrated a good correlation in the results. The study results showed that EEG basic index of alpha band in task1 is higher than task3. It demonstrated that time pressure is increased with response speed of mental arithmetic. EEG basic index of theta band in task3 is higher than task1. It manifested that rapid response induces the stress of the subjects and tardy response make the subjects easy. EEG basic index of beta band, i.e. alert level, was increased with response speed of mental arithmetic. It explained that the subjects need to pay more attention to finish the mental arithmetic under time pressure, but as faced high level of time pressure their concentration would lower. The P300 amplitude at all recording site tended to increase from time pressure level 1 to level 2, while presented significantly decreasing from time pressure level 2 to level 3 (especially at O1). The result displayed that the ability of information process is decreased under time pressure. NASA-Task Load Index (TLX) rating scales in the 3 mental arithmetic tasks showed no significant differences. It mani‐ fested that subjective assessment by using questionnaire is not sensitive for mental pressure and appear the valuable application by using physiological measurement.

References Donchin, E.: Event-related brain potentials: a tool in the study of human information processing. In: Begleite, H. (ed.) Evoked Brain Potentials and Behavior. Plenum Press, New York (1979) Eriksen, A., Eriksen, C.W.: Effects of noise letters upon the identification of a target letter in a nonsearch task. Percept. Psychophys. 16, 143–149 (1974) Hart, S.G., Staveland, L.E.: Development of NASA-TLX (Task Load Index): results of experimental and theoretical research. In: Hancock, P.A., Meshkati, N. (eds.) Human Mental Workload. Elsevier, Amsterdam, pp. 39–183 (1988) Holm, A., et al.: Estimating brain load from the EEG. Sci. World J. 9, 639–651 (2009) Isreal, J.B., Chesney, G.L., Wickens, C.D., Donchin, E.: P300 and tracking difficulty: evidence for multiple resources in dual-task performance. Psychology 17, 259–273 (1980a) Isreal, J.B., Wickens, C.D., Chesney, G.L., Donchin, E.: The event-related brain potential as an index of display monitoring workload. Hum. Factors 22, 211–224 (1980b) Fisch, J.: Sphelmann’s EEG Primer, 2nd edn. Elsevier Science BV, Amsterdam (1991) Kramer, A.F., Wickens, C.D., Donchin, E.: An analysis of the processing demands of a complex perceptual-motor task. Hum. Factors 25, 597–622 (1983) Kramer, A.F., Wickens, C.D., Donchin, E.: Processing of stimulus properties: evidence for dualtask integrality. J. Exp. Psychol. Hum. Percept. Perform. 11, 393–408 (1985) Lange, J.J., Wijers, A.A., Mulder, L.J., Mulder, G.: Color selection and location selection in ERPs: differences, similarities and Fneural specificity. Biol. Psychol. 48(2), 153–182 (1998) Lin, Y.L., Hwang, S.L.: The application of the loglinear model to quantify human error. Reliab. Eng. Syst. Saf. 37(2), 157–165 (1992) Mangun, G.R., Hillyard, S.A.: The spatial allocation of visual attention as indexed by event-related brain potentials. Hum. Factors 29, 195–211 (1987) Okita, T., Wijers, A.A., Mulder, G., Mulder, L.J.M.: Memory search and visual spatial attention: an event-related brain potential analysis. Acta Psychol. 60, 263–292 (1985)

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Semlitsch, H.V., Anderer, P., Schuster, P., Presslich, O.: A solution for reliable and valid reduction of ocular artifacts, applied to the P300 ERP. Psychophysiology 23, 695–703 (1986) Ullsperger, P., Metz, A.-M., Gille, H.G.: The P300 component of the event-related brain potential and mental effort. Ergonomics 31, 1127–1137 (1988) Ullsperger, P., Neuman, U., Gille, H.-G., Pietschann, M.: P300 component of the ERP as an index of processing difficulty. In: Flix, F., Hagendor, H. (eds.) Human Memory and Cognitive Capabilities. North-Holland, Amsterdam (1986) Wijers, A.A., Lamain, W., Slopsema, S., Mulder, G., Mulder, L.J.M.: An electrophysiological investigation of the spatial distribution of attention to coloured stimuli in focussed and divided attention conditions. Biol. Psychol. 29, 213–245 (1989a) Wijers, A.A., Mulder, G., Okita, T., Mulder, L.J.M., Scheffers, M.K.: Attention to colour: an ERPanalysis of selection, controlled search, and motor activation. Psychophysiology 26(1), 89– 109 (1989b)

A Pilot Study Evaluating the Utility, Acceptability, and Feasibility of an Abbreviated Mindfulness Meditation Program Before and During Army Warfighting Training Valerie J. Rice1(&), Gary L. Boykin1, Cory R. Overby2, Angela Jeter2, and Jessica Villarreal2 1

Army Research Laboratory, Ft. Sam Houston, San Antonio, TX, USA {valerie.j.rice.civ,gary.l.boykin.civ}@mail.mil 2 DCS Corporation, Alexandria, VA, USA {cory.r.overby.ctr,angela.d.jeter.ctr, Jessica.L.Villarreal.ctr}@mail.mil

Abstract. Mindfulness meditation training (MMT) is effective in reducing stress and improving performance. However, it is unknown if young, active duty soldiers can, or will, use such training in their daily work. This pilot study investigated an abbreviated MMT format with U.S. soldiers (n = 19) to obtain feedback on its utility, acceptability, and feasibility immediately following MMT and with a subpopulation two months later at the conclusion of a 15-day Army Warfighting Field Training Exercise (FTX) (n = 8). Results showed decreases in self-reported stress, pain, and sleepiness, and increases in energy and work performance immediately post MMT. Volunteers participating in the FTX reported using meditation and/or mindfulness techniques during the FTX, and reported less stress and anxiety and higher work performance than a comparable group that did not receive MMT. These results support the supposition that young, active duty U.S. Soldiers will accept, use, and benefit from abbreviated mindfulness training. Keywords: Military


Mindfulness
Meditation
Stress
Anxiety
Work

1 Introduction Mindfulness is paying attention, on purpose, in the present moment, in a particular way, without judgement [1]. During mindfulness meditation training (MMT), such as Mindfulness-based Stress Reduction (MBSR), attendees learn to focus their attention on present moment sensations, such as touch, interoception (proprioception and somesthesia), hearing, vision, smell, taste, temperature, pressure, equilibrium, etc., as well as on their thoughts and emotions. They learn to notice and attend without judging the sensations, or the experience of sensing, as positive or negative. Through this meditative process, one becomes intimately aware of one’s perceptions and patterns of behavior, which is the first step in moving from ‘mindlessly reacting’ to thoughtful © Springer International Publishing AG (outside the USA) 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_6

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responding. Mindfulness meditation is gaining notice in Western science and society through both practice and research. Early research on the benefits of mindfulness training with U.S. military personnel has shown pre- to post-training improvements in maintenance of working memory during pre-deployment stress [2] and reduction in attentional lapses [3]. The provision of mindfulness training to U.S. military active duty and veterans has shown reductions in symptoms of Post-Traumatic Stress Disorder, stress, and pain [4, 5], as well as improvements in attention [4], sleep quality and vigor [5]. In addition, research within the civilian community shows mindfulness training has diminished anxiety, depression and stress [6], improved emotion regulation [7], reduced negative affect [7], strengthened the immune system [8], and decreased negative behaviors such as substance abuse [9]. Positive findings on the impact of mindfulness training are only militarily relevant if the program is feasible, acceptable, and of utility to the military population. For example, the duration of traditional MBSR training may not be feasible in a military setting. Traditional MBSR training is time consuming, and entails 2½ h sessions once a week for eight weeks, plus an all-day silent retreat between weeks six and seven (total in class hours = 27 h), with approximately 45 min of homework six days a week (*36 h). A shorter version of MBSR training in the civilian community occurs over five days of training in residence (in class hours = 38.5 h), covering the same material presented during the traditional eight week MBSR training class. However, even this may not be as short and easily integrated into military training, as might be preferred. Mindfulness training may not be fully acceptable to a military population, as the terminology, examples, and exercises presented during the training are designed for a civilian population. Mindfulness meditation may be considered out-of-the-realm of the action-oriented, disciplined, team-oriented, hierarchal nature of military culture [10]. While research has yielded positive feedback with active duty [2], oftentimes those who volunteer to participate are more mature in terms of age and military rank [11]. This is because those of higher rank have more influence over their schedules and can more readily choose to participate in a volunteer research program [11]. Yet, just over 66% of U.S. Army active duty soldiers are between the ages of 18 and 30 [12] and the average soldier’s rank is E-4 [10]; therefore, the published research data may not fully represent the U.S. Army population. While research on MMT with military personnel is presented above, no studies were found that investigated the utility of a shorter MMT program or the use of mindfulness techniques during military training exercises that mimic war-time scenarios and are intense, stressful, and action-packed. The purpose of this pilot study was to determine the feasibility, acceptability, and utility of an abbreviated MMT program, offered to U.S. soldiers of ranks E-1 to E-4, and to assess whether soldiers trained in mindfulness would incorporate mindfulness techniques into their schedules while participating in a military Field Training Exercise (FTX).

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2 Methods 2.1

Participants

Research volunteers (n = 19) were recruited from the 47th Brigade Support Battalion located at Fort Bliss, Texas, for this Institutional Review Board approved study. One volunteer withdrew from participating following the first session. Eight of the original 19 volunteers participated in the Army Warfighting Assessment-17 FTX. 2.2

Procedures

Volunteers signed an informed consent form and completed self-report questionnaires on their demographics, stress, anxiety, and work prior to MMT. Volunteers then participated in MMT for three hours per day for four days, based on Dr. Kabat-Zinn’s and the University of Massachusetts Center for Mindfulness MBSR program [1, 13]. Before and after each of the four sessions, volunteers completed ratings on perceived stress, pain, sleepiness, and energy level. At the conclusion of the MMT, volunteers again completed the self-report questionnaires on their stress, anxiety, and work; filled out surveys on mindfulness meditation, the MMT training course, and a user survey; and participated in a focus group (n = 15). Two months later, researchers returned and interviewed eight of the volunteers during the 13th day of the 15-day Army Warfighting Assessment Field Training Exercise. Volunteers completed the stress, anxiety, and work questionnaires for a third time; however, only six soldiers completed all portions of the surveys. As part of a separate assessment by the 47th Brigade Support Battalion, eight individuals participating in the FTX (who did not participate in MMT) completed the surveys on stress, anxiety, and work, and with their permission, this collective, descriptive data was viewed alongside data from this study. 2.3

Questionnaires

Demographic Questionnaire. Demographic questions included age, race, gender, level of education, marital status, branch-of-service, time-in-service, number of deployments, number of deployments in harms’ way, and a self-rating of overall health. Perceived Stress Scale (PSS). The PSS is a 10-item instrument that uses a five-point Likert response scale (0 = never, 1 = Almost Always, 2 = Sometimes, 3 = Fairly Often, 4 = Very Often) to quantify stress levels. The PSS identifies factors contributing to the participant’s experience of stress, and has been found to be reliable and valid [14, 15]. State-Trait Anxiety Inventory (STAI). The STAI measures trait and state anxiety [16], with 20 items for assessing trait anxiety and 20 for state anxiety. Only state anxiety was measured for this study. State anxiety items include: “I am tense; I am worried” and “I feel calm; I feel secure.” All items are rated on a 4-point scale (e.g., from “Almost Never” to “Almost Always”). Higher scores indicate greater anxiety. Internal consistency coefficients for the scale have ranged from .86 to .95; test-retest reliability coefficients have ranged from .65 to .75 over a 2-month interval [16]. Construct and concurrent validity of the scale have been demonstrated [17].

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Work Survey. The work survey was developed by our laboratory as a measure of work performance. It has 20 questions about participants’ work-related attention, communication, stress, creativity, productivity, and emotions, and uses a five-point Likert scale (1 = Strongly Disagree, 2 = Disagree, 3 = Neither Agree or Disagree, 4 = Agree, 5 = Strongly Agree) [18]. Scores are summed, with total scores ranging from 20 to 100. Higher scores show more positive self-ratings of one’s work performance. Daily Questionnaire. Participants completed this four item questionnaire before and after each of the four MMT training sessions. The first question uses the Stanford Sleepiness Scale [19]. The other three questions used 10-point, anchored scales ranging from “1 = no stress/no pain/no energy at all, to 10 = extremely stressed/highest pain/highest energy”. Mindfulness Meditation Feedback. This questionnaire allowed volunteers to give feedback about MMT in terms of techniques learned and ratings on whether the training influenced a variety of symptoms. Volunteers used the five-point Likert scale (1 = a lot worse, 2 = worse, 3 = neutral, 4 = improved, 5 = improved a lot) to evaluate the influence of MMT on anxiety, stress, coping, pain, mood stabilizing, anger, happiness, self-compassion, other-compassion, feelings of being calm, energy/fatigue, sleep, mindfulness, ability to concentrate, resilience, or overall health. Mindfulness Meditation Course Feedback. This questionnaire asks participants about their learning experience, plans to use what they learned in the future, and recommendations to make the training more acceptable or relevant to active duty service members. Seven questions use a 6-point scale (1 = Strongly Agree, 2 = Agree, 3 = Neither Agree or Disagree, 4 = Disagree, 5 = Strongly Disagree, 6 = N/A), while three other questions are open-ended. User Questionnaire. The User Questionnaire asks participants about their use of mindfulness techniques during the two months between the time they completed mindfulness meditation training and their participating in the FTX (e.g., Did you use mindfulness techniques? If so, which ones? If not, why not?). It also queries participants about their use of mindfulness techniques during the FTX (e.g., Have you used mindfulness techniques during the FTX? If so, which ones? If so, where and when did you use them? If not, why not?). Mindfulness Meditation Focus Group Guided Questions. This set of questions provides a guideline for the focus group leader to explore the feasibility (ease-of-use, ease-of-integration), acceptability (Is this training acceptable to you Do you believe it will be acceptable to other active duty military personnel? Why or why not? What changes do you recommend?), and utility (Did you use meditation techniques and if you did, were they helpful?). Responses were recorded using video and notes written by staff. 2.4

Statistics

Descriptive analyses included frequencies, means and standard deviations (SD) of the outcome measures. A paired t-test compared pre/post data for the PSS, STAI, and the work survey, with a p-value of .05. Statistical analyses were not performed on the FTX

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data due to the low number of volunteers. Qualitative analysis of focus group information included identifying trends and patterns from the verbalized data, noting context and tone as well as reiterations.

3 Results 3.1

Demographic Information and Questionnaire Results

Most volunteers were Specialists (E-4) (47.4%), followed by Privates (E1 and E2) (36.9%) and Private First Class (E3) (15.8%). Overall, participants were mostly male (78.9%), Caucasian (42.1%, African American = 26.3%, Hispanic = 31.6%), and single (55.6%, married = 36.8%, divorced = 5.3%). Age ranged from 19 to 37 years (M = 23.37, SD = 4.6). While high school degrees were most commonly reported (63.2%), close to one third reported having some college (31. 6%) and one individual had an associate degree (5.3%). The average years of military service was just under two years (21.13 months) and less than 11% had deployed, with one participant having deployed in harm’s way. Participants reported having average and good health (36.8%; 42.1% respectively).

3.2

Questionnaires: Perceived Stress, State-Trait Anxiety, Work

Results of the three administrations of the PSS can be seen in Table 1, showing a decrease in stress following MMT (t(1,14) = 2.56, p = 0.02), and a minimal increase during the FTX compared to post-MMT. Table 2 contains PSS scores at the end of the FTX for the subgroup of MMT volunteers, alongside a comparable group that did not complete MMT, showing higher stress (PSS scores) among those not attending MT. Normative data for the PSS shows the norm for adults less than age 25 to be 16.78 ± 6.86 and those from ages 25–34 to be 17.46 ± 7.31 [20]. Table 1. Volunteers perceived stress, state-trait anxiety, and work scores. *p < .05 pre to post MMT. Questionnaires Perceived stress State-trait anxiety Work

Pre-MMT Mean ± SD Post-MMT Mean ± SD FTX Mean ± SD 17.53 ± 7.08 12.06 ± 7.86* 12.83 ± 7.03 42.26 ± 11.00 35.00 ± 8.17* 36.00 ± 15.19 70.05 ± 16.66 67.17 ± 32.64 84.67 ± 12.53

STAI results for the three administrations are shown in Table 1, showing a decrease in state anxiety pre to post MMT (t(14) = 3.22, p = 0.01), with a minimal increase during the FTX. Table 2 contains State Anxiety scores at the end of the FTX for the subgroup of MMT volunteers, alongside a comparable group that did not complete MMT, showing greater anxiety (State Anxiety scores) among those not attending MMT.

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V.J. Rice et al. Table 2. Scores during FTX for those attending and not attending mindfulness training. Questionnaires Perceived stress State-trait anxiety Work performance

Attended MMT Mean ± SD Did not attend MMT Mean ± SD 12.83 ± 7.03 16.25 ± 5.15 36.00 ± 6.84 42.75 ± 15.19 84.67 ± 12.53 73.50 ± 10.65

Work ratings remained steady from pre to post MMT (t(14) = −2.67, p < 0.02), with scores improved during the FTX (Table 1). Higher overall work ratings are seen in Table 2 for the subgroup of MMT volunteers, alongside a comparable group that did not participate in MMT training. Table 3 shows the change scores per question on the work survey among the research volunteers. The change scores showing improvement by at least 10% from pre (baseline) to post, or pre (baseline) to FTX are in bold (Table 3).

3.3

Daily Questionnaires

Baseline scores from Day 1 prior to MMT were compared to the final training (Day 4) after MMT. Results are shown in the Table 4. Self-ratings of sleepiness and stress decreased over the four days, while energy increased (p < .05). Sleepiness, stress and pain decreased, and energy increased, from pre to post each class session, however these were not accessed for statistical relevance.

3.4

Mindfulness Meditation Feedback

The techniques volunteers listed as being especially helpful during the FTX were sitting and lying meditations, focusing on the breath. The mean rankings of their symptoms, amongvolunteers attending MMT training, are shown in Table 5 , column 2. The percentages of volunteers at the FTX who listed their symptoms as improved can be seen in column 3.

3.5

Mindfulness Meditation Course Feedback, User Questionnaire, and Focus Group

Course Feedback. All volunteers (100%) reported understanding the purpose of meditation, learning enough to meditate on their own, planning to use the information in their personal life, planning to use the meditation downloads or CDs to meditate, and volunteers stated they would recommend the class to others. Volunteers reported the information as helpful and planning to use the information to help with their military work life (83%). User Questionnaire and Focus Groups. The techniques volunteers listed as being especially helpful immediately following MMT were sitting meditation focusing on the breath, walking meditation, mindful movement, and quick means of stress reduction

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Table 3. Volunteer rankings of work responses pre, post, and at the end of the FTX, along Work My stress and tension levels were low throughout the days of the exercise I was happy at work My emotions were even (did not fly off the handle or become highly emotional) I was creative at work I felt competent at work My thinking was clear I was satisfied with my work I communicated effectively I took care of my personal health I felt empowered to take on challenges I identified growth and development opportunities I was able to focus and concentrate I was able to complete daily tasks efficiently I was productive at work I was engaged in my activities I felt like part of a team I was accepting of other’s attitudes and feelings I approached challenges calmly I was fully aware of safety concerns at work I was content with my work

Pre MMT 3.00

Post MMT 4.40

Pre/Post change 1.40

FTX 4.17

Pre/FTX change 1.17

3.21 3.22

4.27 4.07

1.06 0.84

4.33 4.00

1.12 0.78

3.17 3.63 3.26 3.41 3.72 3.74 3.42 3.74

4.00 4.33 3.93 4.07 4.33 4.33 3.93 4.20

0.83 0.70 0.67 0.65 0.61 0.60 0.51 0.46

4.17 3.33 3.33 4.67 4.67 4.83 4.17 3.83

1.00 –0.30 0.07 1.25 0.94 1.10 0.75 0.10

3.42 4.05

3.80 4.27

0.38 0.21

4.83 4.60

1.41 0.55

3.79 3.89 3.58 3.74

4.00 4.07 3.73 3.87

0.21 0.17 0.15 0.13

4.33 4.50 3.83 4.00

0.54 0.61 0.25 0.26

3.47 4.16

3.60 4.21

0.13 0.06

4.33 4.67

0.86 0.51

3.47

3.47

–0.01

4.83

1.36

using breath or energy techniques. Half of the soldiers reported using mindfulness techniques during the two months between training and the FTX. All soldiers reported using mindfulness during the FTX. The barriers to using mindfulness were cited as lack of time, forgetting techniques, and feeling self-conscious. Several participants stated their supervisors “joked about” or “made fun of” the mindfulness training, increasing their self-consciousness about using techniques that were more visible. Techniques described as helpful during the FTX were focusing on breathing, especially before falling asleep, and walking meditation, which could be done while walking to and from one’s assignments. Volunteers also reported using the quick methods for stress reduction using breathing or energy techniques. Volunteers described situational use of meditation when dealing with high stress or anger using walking meditation or focusing on sound. They described the primary usefulness (of mindfulness) in the field environment as calming and relaxing, helping them understand others’ motivations and actions, improving their communication with others, and helping them sleep.

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V.J. Rice et al. Table 4. Daily ratings taken before and after mindfulness training. Daily Reports Sleepiness Day 1 Day 2 Day 3 Day 4 t Sig.a Pre MMT 3.80 2.73 2.57 1.92 2.610 0.026 Post MMT 3.00 2.69 2.00 1.67 Stress Pre MMT 4.69 2.88 3.40 2.43 5.196 S > N > T. The algorithm has been carried out in the QtCreator software using OpenCV libraries for digital processing of images. In Fig. 1 shows the block diagram of the proposed.

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Fig. 1. The block diagram of proposed system

2.1

Pre-processing of the Biomedical Imaging

The most important part of the background image of the eye [14, 15] is the optic nerve which represents our region of interest (ROI). In the ROI the system performs a cut of 220  220 of the original image (Fig. 2), converting to grayscale and found-do the minimum and maximum values for the brightest part, is the disc and the optic cup.

Fig. 2. Cropped image in the region of interest [11]

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Extraction of Features of the Optic Nerve

The main thing for the detection of glaucoma is to observe clearly the regions of both the optical disc as of the optic cup [16], so it is used the image in the ROI in gray scale by reducing noise and the parties little significant using the Gaussian smoothing filter, also runs the operation morphological dilation. For the elimination of the blood vessels on the outside of the optical disc has been binarized image, in the same way a new operation morphological erosion, and later bilateral filter is used to observe in a more detailed way the contour of the optical disc as shown in Fig. 3.

Fig. 3. Features extracted from the optic nerve [11]

2.3

Display of the Disc and the Optic Cup

It is essential to obtain only the outline of the disc for this eliminates the blood vessels of the inner part of the contour performing an operation or between the binarized image - dilated and the image generated with the adaptive filter. There is still some noise and unwanted traits in the outer part of the outline of the contour disc, so again it is binarized and applies anti-aliasing filter Gaussian, finally erodes to obtain an outline fully merged. The contour of the cup is identified through the binarized and maximum value for the region with higher brilliance within the optic nerve (Fig. 4).

Fig. 4. Display of the disc and the optic cup [11]

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2.4

Relationship Cup-Disc

The relationship cup-Disc, (CDR) [12, 14, 17], is a technical proposal for the presumptive detection of glaucoma by measuring the excavation of the optic nerve in relation to the disc, which is appropriate to calculate the relationship between the contours of the disc and the cup using Eq. (1). Therefore it is estimated by means of a software which gives us a result where: RCD < 0.3 Do Not Have Glaucoma; 0.3 < RCD < 0.5 Glaucoma Suspect; COR > 0.5 Have Glaucoma. R¼

Ac Ad

ð1Þ

Where: • Ac represents the Cup Area. • Ad represents the Disc Area.

2.5

ISNT Rule

The ISNT rule [18–20], is another method used for the detection of Glaucoma. In this rule, the characteristics of the neuroretinal rim are removed, where it is essential to obtain the areas of the four regions (inferior, superior, nasal and temporal). In addition, it is important to detect the side of the eye to the side regions, for which are used the centers of mass and is the side on which are found those points. The area of each region is obtained by the count of the pixels in white as shown in Fig. 5. Then applies ISNT rule (I > S > N > T) to give a diagnosis.

Fig. 5. Visualization of the regions ISNT [11]

3 Experimental Results The first step is performed with this software is the identification of the disc and the Cup, to proceed with the relationship cup-disc. In Table 1, we observe the biomedical image of the fundus of the eye and adjacent to this is the processed image, where the disc is the outline of black color and the cup is the outline of white.

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Table 1. Automatic identification of the disc and the cup with the proposed algorithm [11]

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In Table 2, we can see a comparison between of the different diagnoses obtained by the clinic “Santa Lucía” and the proposed algorithm. Obtaining an average relative error of 4.5%, with a standard deviation of 0.062, which determines that the proposed algorithm has enough effectiveness. Table 2. Automatic identification of the disc and the cup with the proposed algorithm [11]. Relationship Cup-Disc Patients Diagnostic (Santa Lucía clinic)

Diagnostic (Proposed algorithm)

ISNT Rule Doctor of ophthalmology (Santa Lucía clinic)

Proposed algorithm

1 2 3 4 5

Yes Yes Yes Suspect Yes

Yes Yes Not Yes Yes

Yes Yes Yes Yes Yes

Yes Yes Yes Suspect Yes

System error with CDR 7,12% 8,15% 9,64% 2,95% 4,84%

In the Table 3, shows the statistical results with the rule ISNT of the proposed system with true positive (TP), true negative (TN), false positive (FP) and false negative (FN); getting the accuracy (ACC) (2) of 81.94%, specificity (SPEC) (3) of 59.1%, and sensitivity (4) (SNB) of 92%. ACC ¼

TP þ TN TP þ TN þ FP þ FN

ð2Þ

TN TN þ FP

ð3Þ

SPEC ¼ SNB ¼

TP TP þ FN

ð4Þ

Table 3. Statistical results of the proposed system [11] ISNT rule True False ACC SPEC SNB Positive 46 9 81,94% 59,1% 92% Negative 13 4

4 Discussion and Future Work The processes of early detection of glaucoma are often poorly accessible, the higher cost, by the number of tests that should be performed and, by the time it takes to give the results, that is why this work aims to be a tool to support the early presumptive diagnosis of glaucoma.

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To determine the amount of healthy nerve fibers is a more complex process to analyze and determine a percentage considered suitable for optimum viewing. Therefore, the collaboration of specialists in the Santa Lucia Clinic is fundamental for the development of this research, the validation of this proposal and its possible implementation, it is important to be able to count with an appropriate tool for the prevention of Glaucoma. Glaucoma is one of the main causes of visual impairment in the world, because it is a disease that has no symptoms at an early stage, therefore there are several techniques of eye measurements as: Campimetry, Tonometry, Pentacam, optical coherence tomography, among others. The disadvantage is the high cost in the carrying out of examinations, so that the proposed software could be used in all the clinics, being only necessary the images of the human eye fundus. The digital processing of images is primordial for identification of the optic nerve, so that the proposed system performs two methods for the detection of glaucoma, using the relationship cup-disc (RCD) and by means of the ISNT Rule; where, areas of the disc and the cup are necessary for the calculation of the RCD, which is an alternative method to determine if the patient is suspected of having glaucoma. The calculation of the RCD can be affected with images of the eye of people with a large optical nerve, therefore, it is essential to make the ISNT rule, by measuring the neuroretinal rim and noting that meets the condition of R + S > N + T, as with the four regions analyzed, there will be a greater accuracy and the specialist will be able to give a clear diagnosis. The graphical interface in this software, it will be of great benefit to the specialists, because, it shows responses and diagnostics with the two methods proposed in an automatic way. Appended to this the results can be saved in the PDF format files, which help you to compare with future results and make a follow-up to the disease. The relationship has been compared cup – disc of the Santa Lucia Clinic, with the proposed algorithm resulting in an error on average of 4.5%, which is satisfactory because the results are mostly reliable. For future project proposals related to this topic, it is recommended to carry out a study on the number of nerve fibers in the human eye to determine if you have any anomaly or is healthy. Acknowledgments. This research project would not have been possible without the support of the Research Group of Artificial Intelligence and Support Technology and of the Research Group in Biomedical Engineering of the Universidad Politecnica Salesiana of Cuenca. Special thanks also to Dr. Carlos Luis Chacón from Santa Lucía clinic in Quito, and the University of Piura – Perú, and its Engineering Doctorial Program, DICOP.

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References 1. Ecuador Vulnerable a la Ceguera. http://ns1.ecuadorinmediato.com/index.php?module= Noticias&func=news_user_view&id=3228&umt=ecuador_vulnerable_a_ceguera 2. Pinos, E., Ingavelez, P.: “Análisis de los diagnósticos de discapacidades en la provincia del Azuay y propuesta de desarrollo de tecnologías inclusivas”. INGENIUS, Número 6, (julio/diciembre), pp. 29–36. Revista de Ciencia y Tecnología de la Universidad Politécnica Salesiana del Ecuador (2011) 3. Robles Bykbaev, V., Pinos Vélez, E., Ingavelez Guerra, P.: An educational approach to generate new tools for education support of children with disabilities. In: 2011 International Conference on IEEE Xplore, e-Education, Entertainment and e-Management, pp. 80–83 (2011) 4. Lotankar, M., Noronha, K., Koti, J.: Detection of optic disc and cup from color retinal images for automated diagnosis of glaucoma. In: 2015 IEEE UP Section Conference on Electrical Computer and Electronics (UPCON), Allahabad, pp. 1–6 (2015) 5. Salam, A.A., Akram, M.U., Wazir, K., Anwar, S.M., Majid, M.: Autonomous Glaucoma detection from fundus image using cup to disc ratio and hybrid features. In: 2015 IEEE International Symposium on Signal Processing and Information Technology (ISSPIT), Abu Dhabi, pp. 370–374 (2015) 6. Aguilar, E., Reyes, S., Perez, F.: Glaucoma: La Enfermedad Silenciosa, Centro optometría internacional, Junior (2006) 7. Bright Focus Foundation National Glaucoma: Datos Esenciales. http://www.brightfocus.org/ sites/default/files/essentialfactsonglaucoma_spanish.pdf 8. Organización Mundial de la Salud; Ceguera y discapacidad visual. http://www.who.int/ mediacentre/factsheets/fs282/es/ 9. Dr. Eugenio Maul de la Puente “GLAUCOMA” Departamento De Oftalmología-Curso de Oftalmología (2011) 10. Quigley, H.A., Broman, A.T.: The number of people with Glaucoma worldwide in 2010 and 2020. Br. J. Ophthalmol. 90(3), 262–267 (2006) 11. Encalada Ojeda, M.S., Gamboa Vinueza, E.G.: Desarrollo de un sistema de soporte a la detección del glaucoma a través de procesamiento digital de imágenes biomédicas del fondo de ojo y uso de software libre, Universidad Politecnica Salesiana, Cuenca, Ecuador (2016) 12. Tombran-Tink, J., Barnstable, C.J., Shields, M.B.: Mechanisms of the Glaucoma, disease process and therapeutic modalities. Ophthalmology Research. Human Press. ISBN: 978-1-58829-956-7 (2008) 13. Martín, P.B.: Estudio de la Dinámica del humor acuoso mediante fluorofotometría en el glaucoma de ángulo abierto, Departamento de Oftalmología, Facultad de Medicina, Universidad Complutense de Madrid, Madrid (2001) 14. Antonio, F.: Glaucoma Imaging. Springer (2016). ISBN: 978-3-319-18958-1 15. National Eye Institute. Caption: Series of four photos demonstrating typical progression of vision loss due to glaucoma. http://www.visionaware.org/info/your-eye-condition/glaucoma/ patients-guide-to-living-with-glaucoma/125 16. Giraldo, J.C.R., Flectcher, J.J., McCollough, C.H.: Reducción del ruido en imágenes de tomografía computarizada usando un filtro bilateral anisotrópico-Noise reduction in computed tomography images using an anisotropic bilateral filter. Revista Ingeniería Biomédica 4(7), 62–68 (2011) 17. Martins Joao, C., Sousa Leonel, A.: Bioelectronic Vision, Retinal Models, Evaluation Metrics and System Design. Series on Bioengineering & Biomedical Engineering, vol. 3. World Scientific, ISBN-13 978-981-279-430-7 (2009)

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18. Dutta, M.K., Mourya, A.K., Singh, A., Parthasarathi, M., Burget, R., Riha, K.: Glaucoma detection by segmenting the super pixels from fundus colour retinal images. In: 2014 International Conference on Medical Imaging, m-Health and Emerging Communication Systems (MedCom), Greater Noida, pp. 86–90 (2014) 19. Lotankar, M., Noronha, K., Koti, J.: Detection of optic disc and cup from color retinal images for automated diagnosis of glaucoma. In: 2015 IEEE UP Section Conference on Electrical Computer and Electronics (UPCON), Allahabad, pp. 1–6 (2015) 20. Rocío, A., Sebastián, T.: Simulación y modelamiento del ojo humano como herramienta para la prevención del Glaucoma a través de la medición de la Presión Intraocular. Universidad Politécnica Salesiana (2015)

A RGB-D Sensor Based Tool for Assessment and Rating of Movement Disorders ( ) Vitoantonio Bevilacqua1 ✉ , Gianpaolo Francesco Trotta2, Claudio Loconsole1, 1 Antonio Brunetti , Nicholas Caporusso1, Giuseppe Maria Bellantuono1, Irio De Feudis1, Donato Patruno1, Domenico De Marco1, Andrea Venneri1, Maria Grazia Di Vietro3, Giacomo Losavio3, and Sabina Ilaria Tatò3

1

Department of Electrical and Information Engineering, Polytechnic University of Bari, Bari, Italy {vitoantonio.bevilacqua,claudio.loconsole, antonio.brunetti}@poliba.it, [email protected], [email protected], [email protected], [email protected] 2 Department of Mechanics, Mathematics and Management, Polytechnic University of Bari, Bari, Italy [email protected] 3 Medica Sud S.R.L., Viale della Resistenza n.82, Bari (BA), Italy [email protected]

Abstract. The assessment of tremor features of subjects affected by Parkinson’s disease supports physicians in defining customized rehabilitation treatment which, in turn, can lead to better clinical outcome. In the standard assessment protocol patient performed many exercises that are useful to physicians to rate disease. But the rating is subjective since is based on an observational evaluation. In this paper, we introduce a novel method for achieving objective assessment of movement conditions by directly measuring the magnitude of involuntary tremors with a set of sensors. We focused on one of the standard tasks of the Unified Parkinson’s Disease Rating Scale: finger-to-nose maneuver. During the task, data related to patient finger position are stored and then some tremor’s features are extracted. Finally, we employ a Support Vector Machine to measure the relevance of the extracted features in classify healthy subjects and patients. Keywords: Parkinson disease · Finger-to-Nose maneuver · Kinect sensor · Support vector machine · Classification

1

Introduction

Parkinson’s disease (PD) is a neurodegenerative condition. Unfortunately, no treatment is currently available. Nevertheless, many studies proved that different therapies may increase the quality of life of patients, reducing instability, gait disorders, and motor impairment, which are just some of the symptoms.

© Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_12

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The Unified Parkinson’s Disease Rating Scale (UPDRS) [1] is a tool that supports the assessment of the course of PD over time. In 2007, the Movement Disorder Society (MDS) published a revision of the UPDRS, known as the MDS-UPDRS that consists in four parts: Part I (non-motor experience in daily living), Part II (motor experience in daily living), Part III (motor examination), and Part IV (motor complications). In this paper, we specifically focus on improving part III. Usually, during motor examination, the patient realizes a set of different physical exercises. Simultaneously, physicians realize an observational assessment to identify and rate dyskinesia (chorea or dystonia). However, subjective evaluation affect the quality of results. Therefore, in this paper, we introduce a system for providing physicians with quantitative metrics, which would render the assessment of disease severity more objective. To this end, we designed a system, based on the use of a sensor embedded in a commercial device (i.e., Kinect®), which extracts the features of tremors during the finger-to-nose task inspired by the MDS-UDPRS scale.

2

Related Works

The aim of several recent studies is to objectify the measurement of disorders to over‐ come current limitations of assessment protocols and disease rating scales [2], in which qualitative evaluation affects accuracy. Other studies focus on adherence to motor rehabilitation, and they aim at motivating PD patients to adhere to the exercise routine in order to improve the outcome of the treatment [3] [4]. The assessment of the severity of movement disorders in PD is essential for the development of new treatments and for improving the quality of life of patients. Hence, the scientific community working on PD is fostering the idea that a new objective method should be developed to increase accuracy, render results reproducible, and lower the assessment cost. In this regard, wearable and infrastructure-based systems, such as, Myo® and Kinect®, are among the most used devices for experimenting novel proto‐ cols [5]. Moreover, serious games and, in particular, approaches based on Augmented Reality and on Virtual Reality (AR/VR), are gaining increasing interest in the community, because they relief patients from the stress of being examined; also, being engaged in interaction with VR prevents anxiety, frustration, and other side effects which might affect performance [6]. In this paper, we introduce and present the evaluation of a system which objec‐ tively measures patient’s performance in finger-to-nose sessions. Specific features are extracted to discriminate patients and healthy subjects using machine learning tech‐ niques. Particularly, we take into consideration amplitude and frequency of tremors. In addition to their subjective assessment, physician could use our proposed system (or the features considered by our analysis) for assessing disease severity with higher accuracy.

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Materials and Methods

3.1 Participants In this study, 17 subjects were recruited: 6 PD patients and 11 Control volunteers. Coherently with the MDS-UPDRS scale, in which responses of each hand are eval‐ uated separately, we realized independent acquisitions for each subject’s hand. In the former, where only right hand is observed, 1 female and 5 male patients aged 58–80 years (average 73.8, sd 8.08) and 2 females and 9 male volunteers aged 21–33 years (average 25.63, sd 3.66) were recruited. In the latter, where only left hand is observed, a patient hasn’t been considered because he didn’t show any phenomena observed on the hand. 3.2 Acquisition System Our objective is the implementation of a simple and intuitive system, which, regardless of its simplicity, can assess and classify movement disorders which are typical of PD. To this end, our system extracts significant parameters during the execution of exercises. We consider tremor’s amplitude and frequency, and we collect them with high accuracy (up to one millimeter) in very short time intervals. As a result, we expect our system to be more reliable than the human eye. Our system is based on the following hardware: • Kinect One® Acquisition and analysis software was developed using the following tools: • Unity3D® • MATLAB® Kinect® is equipped with an RGB camera, a double depth infrared sensor consisting of an infrared laser scanner and an infrared camera. The RGB camera has a resolution of 640 × 480 pixels while the infrared uses a 320 × 240 pixel matrix. Kinect® was attached to a telescopic bar along the vertical axis to enable users to change its orientation and position so that it can recognize movements. According to Microsoft, Kinect® can simultaneously track movements of up to 4 people, both standing and sitting. As Kinect® primarily a gaming console intended for entertainment purpose, it is ideal combining experimental acquisition with potential integration of VR [7]. The Kinect® sensor is placed at a height of 80 cm above patient’s head. So, from a raised position it can capture patient’s location and the hand involved in the experiment. In addition, Kinect® was preferred to normal RGB cameras because it captures 3dimensional information, using a depth sensor. Also, it has an infrared camera, which involves realizing calculations using a different wavelength than traditional RGB camera. Finally, it is a relatively low-cost technology, which makes the whole system extremely cheap. In this paper, we mainly focus on one specific exercise to evaluate and characterize the disease:

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• Kinetic tremor of the hands. Kinetic tremor of the hands is evaluated with the finger-to-nose test, which measures smooth, coordinated movement of the upper limbs by having each of the examinees touch the tip their nose with their index finger (Fig. 1). In one variation of the test, examiners hold their finger at about 1 m away from the patient, who is instructed to touch the examiner’s finger, and then, to reach their own nose. The finger-to-nose test is repeated 3 times and should be performed slowly enough not to hide any tremor that could occur with very fast movements of the arm. Then, the test is repeated with the other hand, so that they can be rated separately. The tremor can be detected throughout the movement or when the target (nose or finger) is reached [8]. The greatest detected amplitude is evaluated to identify the presence of conditions.

Fig. 1. Example of the exercise execution

For the experiment, we mainly used the infrared sensor of the Kinect®. In every experiment, it was possible extrapolate all features required for the classification by means of a reflector marker placed on a patient’s finger. Example of typical trajectory during the exercise for PD and Control are shown in Fig. 2.

Fig. 2. Example of trajectory difference between PD and ideal

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3.3 Features We extracted several significant features which are useful for evaluating tremor. Usually, medical specialists observe them without any support tool, i.e., they adopt a qualitative and subjective approach in their evaluation. All the features analysed by our system regard tremor, and they include: • average amplitude; • maximum amplitude; • frequency. During the finger-to-nose experiment, we acquire a cloud of points each representing the spatial position of the marker over three axes (X, Y, and Z), extracted from images captured at a frame rate of 30 FPS (frame per second). Subsequently, we utilize MATLAB to extract the features of interest from the cloud of points. Specifically, we applied linear regression to find the reference line for the specific test. Then, we evaluate the amplitude of tremor, which is calculated as the distance between the reference line and the trajectory of the index finger. This is calculated point by point in each frame. A typical fluctuation pattern of a PD patient is shown in Fig. 3.

Fig. 3. Fluctuation pattern of a PD patient

Specifically, we use Principal Components Analysis (PCA) to fit linear regression [9]. PCA minimizes perpendicular distances from the data to the fitted model. This is the linear case of Orthogonal Regression, or Total Least Squares. This method can be appropriately utilized when there is no natural distinction between the predictor and response variables, or to accommodate for errors in variable. This contrasts with the usual assumption on regression, that predictor variables are measured without any errors, whereas only the response variable can have an error component. Figures 4 and 5 show an example of a cloud of points extracted from subject’s movement and the respective fit line.

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Fig. 4. Cloud of points representing the trajectory of the index finger

Fig. 5. Reference line of the trajectory of the index finger

We consider frequency as a third feature. In particular, we use the average frequency of tremor in every second. We calculate the peaks of the amplitudes during the task by means of the reference line obtained using linear regression, as described previously. We consider each peak as starting point of a tremor. Consequently, we are able to calcu‐ late the number of tremors during the exercise and the medium frequency of tremors per second. During the experiment, we detected some errors in tracking the marker. They are due to light conditions, which can interfere with the infrared sensor of the Kinect® acquisition system. Also, they might be caused by reflective objects in the field of view of Kinect®. Interferences produce detection mistakes, as shown in Fig. 6. Therefore, we filter the selected data with a low-pass filter to remove peaks of amplitude over 20 cm. We choose this threshold because it is twice as much as the maximum severity of the MDS-UPDRS. Therefore, a fluctuation over this threshold is considered as an error of the acquisition system.

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Fig. 6. Example of acquisition: correct tracking (1st and 3rd image) VS tracking error (2nd image)

We designed a SVM classifier [10] to discriminate PD patients from control subjects. SVM is a binary classifier whose goal is to find the best linear decision surface that separates the training features space. SVMs have very good generalization capability because they can be extended in order to separate a space of non-linear input features. Figure 7 shows the performance of our classifier.

Fig. 7. (a) Confusion Matrix for right hand acquisition (b) Confusion Matrix for left hand acquisition

4

Results

We designed different types of SVM classifiers. However, cubic SVM achieved the best results. To avoid data overfitting, we used 5-fold cross-validation. As the dimension of the dataset is relatively small, we realized multiple tests to obtain more reliable results. The SVM approach on right hand yielded an average accuracy close to 82%; indeed, for left hand, it yielded an average accuracy close to 89.5%. This showing the existence of a good separation between the two classes for each case. The confusion matrix of the best SVM model is showed in Fig. 7(a) and (b), and the performance indexes are reported in Eqs. (1), (2), and (3):

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Accuracyright TP + TN = 0.88 TP + TN + FP + FN Sensitivityright TP = 0.66 TP + FN

Specificityright TN =1 TN + FP

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Accuracyleft TP + TN = 0.93 TP + TN + FP + FN

(1)

Sensitivityleft TP = 0.8 TP + FN

(2)

Specificityleft TN =1 TN + FP

(3)

However, due to the low number of instances in the dataset, we suggest to further investigate the reproducibility of our findings.

5

Conclusion

In this paper, we present a novel method to increase objectivity in assessing the severity of Parkinson’s disease. Our method is based on the performance in the execution of specific exercises realized by patients during medical examinations. We aim at supporting physicians with quantitative data about patients’ movements which, in turn, are an indicator of the severity of the disease. To this end, we extract a dataset consisting of three features involved in the finger-to-nose test, and we leverage SVM to classify healthy subjects and patients. The finding of our evaluation of the method showed an average accuracy of 82% for test on the right hand and an average accuracy of 89.5% for test on the left hand, proving the relevance of selected features. Nevertheless, future work will include detailed investigation of our results in additional studies involving a larger group of subjects. Furthermore, more accurate sensors (e.g., Kinect® v2) might mitigate issues caused by the conditions of the examination environment.

References 1. Berganzo, K., Tijero, B., González-Eizaguirre, A., Somme, J., Lezcano, E., Gabilondo, I., Fernandez, M., Zarranz, J.J., Gómez-Esteban, J.C.: Motor and non-motor symptoms of Parkinson’s disease and their impact on quality of life and on different clinical subgroups. Neurología. 31, 585–591 (2016) 2. Nakamura, T., Nishimura, N., Asahi, T., Oyama, G., Sato, M., Kajimoto, H.: Kinect-based automatic scoring system of TWSTRS-severity. Mov. Disord. 29, 1–483 (2014) 3. Palacios-Navarro, G., García-Magariño, I., Ramos-Lorente, P.: A kinect-based system for lower limb rehabilitation in Parkinson’s disease patients: a pilot study. J. Med. Syst. 39, 103 (2015). doi:10.1007/s10916-015-0289-0 4. Espay, A.J.: At-home training with closed-loop augmented-reality cueing device for improving gait in patients with Parkinson disease. J. Rehabil. Res. Dev. 47, 573–582 (2010) 5. Mario, A., Jorge, B., Daniel, M., Pedro, V.: 3D sensors, a new paradigm for assessing Parkinson’s disease. Mov. Disord. 30, 1–703 (2015)

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6. Bevilacqua, V., Brunetti, A., Trigiante, G., Trotta, G.F., Fiorentino, M., Manghisi, V., Uva, A.E.: Design and development of a forearm rehabilitation system based on an augmented reality. In: Italian Workshop on Artificial Life and Evolutionary Computation, vol. 587, 127– 136. Springer, Cham (2015) 7. Microsoft, cur. Kinect. (2010). https://developer.microsoft.com/en-us/windows/kinect/ develop 8. Goetz, C.G., Tilley, B.C., Shaftman, S.R., Stebbins, G.T., Fahn, S., Martinez-Martin, P., Poewe, W., Sampaio, C., Stern, M.B., Dodel, R., Dubois, B., Holloway, R., Jankovic, J., Kulisevsky, J., Lang, A.E., Lees, A., Leurgans, S., LeWitt, P.A., Nyenhuis, D., Olanow, C.W., Rascol, O., Schrag, A., Teresi, J.A., van Hilten, J.J., LaPelle, N.: Movement disorder societysponsored revision of the unified Parkinson’s disease rating scale (MDS-UPDRS): scale presentation and clinimetric testing results. Mov. Disord. 23, 2129–2170 (2008) 9. Petráš, I., Bednárová, D.: Total least squares approach to modeling: a matlab toolbox. Acta Montanistica Slovaca Ročník 15(2), 158 (2010) 10. Bevilacqua, V., Pannarale, P., Abbrescia, M., Cava, C., Paradiso, A., Tommasi, S.: Comparison of data-merging methods with SVM attribute selection and classification in breast cancer gene expression. BMC Bioinform. 13(7), S9 (2012)

A Comprehensive Approach for Physical Rehabilitation Assessment in Multiple Sclerosis Patients Based on Gait Analysis Vitoantonio Bevilacqua1(&), Gianpaolo Francesco Trotta2, Antonio Brunetti1, Nicholas Caporusso1, Claudio Loconsole1, Giacomo Donato Cascarano1, Francesco Catino1, Pantaleo Cozzoli1, Giancarlo Delfine1, Adriano Mastronardi1, Andrea Di Candia3, Giuseppina Lelli3, and Pietro Fiore3 1

Department of Electrical and Information Engineering, Polytechnic University of Bari, Bari, Italy {vitoantonio.bevilacqua,antonio.brunetti, nicholas.caporusso,claudio.loconsole}@poliba.it, [email protected], [email protected], [email protected] 2 Department of Mechanics, Mathematics and Management, Polytechnic University of Bari, Bari, Italy [email protected] 3 Department of Physical Medicine and Rehabilitation, University of Bari “Aldo Moro”, Bari, Italy [email protected], [email protected], [email protected]

Abstract. The assessment of gait features of subjects affected by Multiple Sclerosis supports physicians in defining customized rehabilitation treatment which, in turn, can lead to better clinical outcome. In the standard assessment protocol, an optoelectronic motion system, surface electromyography sensors, and a set of piezoelectric sensors on a force platform acquire large amount of data which is evaluated by physicians for defining treatment. In this paper, we introduce an automatic procedure based on Fuzzy-Granular Computing for evaluating gait metrics: three features extracted from each muscle involved in gait enable to summarize, quantify, and simplify the assessment protocol. Finally, we employ a Support Vector Machine to measure the relevance of the extracted features in classifying healthy subjects and patients using the simplified set of features. Keywords: Gait analysis
Multiple sclerosis
Support vector machine
Fuzzy granular computing
Dynamic time warping
Gait profile score
Classification

© Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_13

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1 Introduction Multiple sclerosis (MS) is a chronic autoimmune, inflammatory neurological disease of the central nervous system (CNS) which leads to damage of myelin and axons. MS shows a highly varied and unpredictable course; in most patients, the early stage of the disease is characterized by episodes of reversible neurological deficits which are often followed by progressive neurological deterioration over time [1]. There is no cure for MS and its management aims to both prevent relapses and reduce the progression of the disease. There are several symptoms of MS, including weakness, paresthesia, spasticity, cognitive dysfunction, fatigue, and walking impairments [2]. Focusing on gait disorders, reduced mobility heavily impairs the quality of life, and the associated accidents increase morbidity and mortality [3]. As gait varies over time, it is necessary to design systems which are able to measure and quantify temporal intra-patient variations by evaluating several parameters and by comparing them with a control group. In this work, we design an innovative system for the physical rehabilitation assessment of MS patients using a set of gait features able to analyze and monitor the follow-up phase of the disease. This goal is achieved by means of Gait Analysis, which allows to synchronously record 3-Dimensional spatial position of anatomical landmarks, ground reaction force exerted on platforms, and sEMG signal from sensors placed on the muscles of the lower limbs. After the data acquisition phase, temporal, spatial, kinetic, and kinematic gait parameters are computed to evaluate patients’ conditions and walking capability. Then, physicians examine large amount of data and evaluate the condition of the patient. In this work, we aim at optimizing standard gait analysis measurement protocols by introducing a novel type of index which summarizes, quantifies, and simplifies the assessment of the impairment. Furthermore, a more detailed and accurate analysis of human gait can be achieved by decomposing the walking-cycle in seven phases that are, loading response (LR), mid-stance (MST), terminal stance (TST), pre-swing (PSW), initial swing (ISW), mid-swing (MSW), and terminal swing (TSW). This categorization provides physicians with the opportunity of prescribing specific rehabilitation treatment for a defined group of muscles. As a result, each individual patient receives a personalized therapy.

2 Related Work In the literature, several studies focus on the evaluation of walking patterns and on the estimation of the differences between healthy subjects and patients. For instance, novel metrics include distance measurement based on Dynamic Time Warping (DTW) [4], Gait Profile Score (GPS) [5], and similarity measures based on Fuzzy-Granular Computing [6]. The latter specifically enables focused rehabilitation treatment on the most impaired phases of the gait cycle. As a result, they enable monitoring the intra-patient follow-up of the condition to validate the efficacy of the proposed rehabilitation therapy.

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Dynamic Time Warping

The problem of finding time correspondence between two different data sets is known in the majority of scientific research areas. One of the well-known techniques which can be used to cope with this issue is Dynamic Time Warping (DTW) [7]. DTW is an algorithm which aligns two sequences and provides an estimation of their distance. This algorithm is particularly useful to compare signals when the simple linear compression or expansion does not yield satisfactory results. It has been used in various applications, from movement recognition in humans [8] to bioinformatics [9]. DTW defines a cost function and uses nonlinear transformation to warp the two sequences to minimize the cost function. The optimal value of the cost function is the distance measure between the two sequences [4]. For this reasons, DTW is suitable for comparing human gait cycle sequences, because each of them includes the same gait phases having different duration. 2.2

Gait Profile Score

Gait Profile Score (GPS) is a measure of gait quality based on the Gait Deviation Index [10]; it quantifies the deviation in the gait pattern of the patient with respect to the normality range. A correlation between Gait Variable Score (GVS) and Expanded Disability Status Scale (EDSS) has been discovered and presented in several studies [11], showing the potential effectiveness of this metric. In a gate cycle, we consider nine variables vi: pelvis (i.e., tilt v1, rotation v2, and obliquity v3), hip (i.e., flex-extension v4, adduction-abduction v5, and rotation v6), knee flex-extension v7, ankle dorsal-plantar flexion v8, and foot progression v9. For each variable vi, a GVS is defined as the vi Root Mean Square (RMS) difference between the subjects and the control group. An example of GVS computation for knee flexion-extension is shown in Fig. 1. After the computation of the nine GVS, the GPS value can be evaluated using the following Eq. (1): rffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi 1 XN GPS ¼ GVS2i i¼1 N

2.3

ð1Þ

Fuzzy-Granular Computing

Fuzzy-Granular Computing differs from previously-defined techniques because it enables accurate analysis of each phase of the gait cycle. The application of a Fuzzy-Granular model produces an accurate representation and quantification of the information in the sEMG signal of each gait phase [6]. Usually, for slowly time-varying signals, the mean value is used for granule representation. Conversely, sEMG are irregular time-varying signals having typical peaks and valleys. Thus, we adopted a fuzzy-triangular membership function to characterize, quantify and represent each phase in a more accurate way. Further details on Fuzzy-Granular Computing and the proper application on the sEMG signal and on the gait phase is presented in Sect. 3.4.

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Fig. 1. Examples of GVS calculation for the flexion-extension of the knee. The higher the GVS value is, the larger will result the deviation from the physiological gait of the individual with higher EDSS.

3 Materials and Methods 3.1

Participants

In the study, 7 MS patients (2 male and 5 female, aged 19–45 years) were enrolled in the test group. The matched control group consists of 7 healthy volunteers (6 male and 1 female, aged 25–49 years) with no previous history of neurological disorders or any disease that could affect gait parameters. Table 1 summarizes information about subjects. Table 1. Age, weight, and height in MS and Control subjects (average and standard deviation). Age Weight (kg) Height (cm) BMI (kg/m2)

3.2

MS subjects 32.43 (± 9.22) 60.71 (± 10.86) 168.29 (± 7.89) 21.30 (± 2.11)

Control subjects 29.57 (± 8.68) 71.00 (± 16.36) 174.14 (± 4.74) 23.25 (± 4.29)

Acquisition System

In this section, we discuss the acquisition and analysis of data from gait. Our system enables synchronous recording of: (1) the 3-dimensional spatial position of anatomical landmarks according to the Davis protocol [12], (2) surface EMG signals of the main muscles of the lower limbs involved in gait, and (3) ground reaction data acquired by force platforms.

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The system was provided by BTS Bioengineering® (BTS, Milano, Italy) and located in the Gait Analysis Lab of the Department of Physical Medicine and Rehabilitation of the University of Bari “Aldo Moro”. The optoelectronic motion system is based on 8 infrared cameras recording at 100 FPS for the detection of movements of 20 reflective spherical markers. Surface electromyography (sEMG) signals are recorded with a set of 8 wireless sEMG sensors at a sampling rate of 1 kHz. Ground reaction forces are recorded with 2 piezoelectric force platforms at a sampling rate of 400 Hz. RGB videos of examinations are recorded from 3 different points of view using 3 IP cameras at a rate of 25 FPS. 3.3

Clinical Examination

In the first step of the exam, personal data are collected from each subject. Data include personal details (name, age, height, and weight) and anthropometric measurements of the lower limbs (hip width, hip height, total limb length, knee diameter, and ankle diameter). The second step consists in placing the 20 markers on the anatomical landmarks described in the Davis protocol [12]. Two additional markers are placed on each calcaneus for the first phase of the recording process. After skin preparation, 8 sEMG sensors are placed above the main muscles involved in gait, that is, Tibialis Anterior, Gastrocnemius Medialis, Rectus Femoris, and Semimembranosus. After the initial setup, a standing session of about 10 s is recorded to evaluate the resting state of the joints; this will be used during data pre-processing for the computation of angles offset. Then, the subject is required to realize a variable number of walking sessions at a self-selected walking speed. During each walking session, the subject walks along the platform without being aware of the position of force sensors. This is to avoid any external influence in the evaluation of the walking ability of the subject.

3.4

Fuzzy-Granular Computing

In this study, we used Fuzzy-Granular Computing (FGC) to find an optimal representation of the sEMG signal. To enhance reliability and specificity of the analysis, we subdivide the gait cycle into seven phases; also, we compute a granular representation for each of them. The computation of fuzzy granulation requires a preliminary step in which we pre-process the raw sEMG signals (Fig. 2.left). First, the full-wave rectification is evaluated to filter negative values out of the original time-series. Then, we filter the signal using a 2nd order low-pass Butterworth filter [13] with 10 dB cut-off frequency (Fig. 2.right). Individual differences in walking speed are avoided through min-max normalization of the original time-series data S0 according to Eq. (2): S¼

S0  minðS0 Þ maxðS0 Þ  minðS0 Þ

ð2Þ

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Fig. 2. Raw sEMG signal from the right gastrocnemius medialis (left). Filtered and normalized sEMG signal from the right gastrocnemius medialis (right).

After normalization, for each segment in the interval [a, b], the triangular fuzzy set membership function is established as: xa ; x 2 ½a; m ð3Þ la;m;b ðxÞ ¼ ma la;m;b ðxÞ ¼

bx ; x 2 ½m; b bm

ð4Þ

where a is the left bound, b is the right bound and m is the modal or core value. As reported in [14], we chose the median as the core value because it is a robust estimator because its value does not depend on any outliers (despite the mean value). In Eqs. (3) and (4), the core value splits the data into two subsets that are processed separately to yield the computations of the left and right portions of the membership function (i.e., increasing and decreasing portion). To obtain the optimal values for a, we search through all data points of the increasing portion [a, m] considering each of them as a potential value of the parameters of the membership function. A visual explanation is shown in Fig. 3. Equation 5 finds the optimal value of a which maximizes the performance index: N X la;m;b ðxk Þ QðaÞ ¼ ð5Þ ma k¼1 xk \m where N is the number of data points in the increasing portion. In the same way, the optimal value for b is evaluated maximizing the performance index: T X la;m;b ðxk Þ QðbÞ ¼ ð6Þ bm k¼1 xk [ m where T is the number of data points in the decreasing portion.

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Fig. 3. Computation of a as a parameter in the increasing portion

Using the granular matrix such as the one shown in Eq. (7) reporting the matrix related to the right gastrocnemius medialis, the final representation of the original time series is defined; columns and rows represent the gait phases and the fuzzy parameters, respectively. The granular matrix for each muscle is evaluated. 0 Ba G¼B @m b

P1 0; 5391 0; 6241 0; 9594

P2 0; 2742 0; 4865 0; 5429

P3 0; 0935 0; 4933 0; 5028

P4 P5 0; 1102 0; 0298 0; 1669 0; 2450 0; 6165 0; 7466

P6 0 0; 0808 0; 1173

1 P7 0; 2852 C C 0; 2899 A 0; 9765 ð7Þ

An example of granulated signal is shown in Fig. 4.

Fig. 4. Granulated representation of the sEMG signal from the right gastrocnemius medialis.

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We can define the fuzzy similarity between two granulated sEMG signals as: S ¼ G H ¼

minðgij ; hij Þ maxðgij ; hij Þ

ð8Þ

where G and H are the granular matrices of the two compared time-series, “*” is the fuzzy-correlation operator, “min” and “max” are the fuzzy-intersection and fuzzyunion, respectively. The values of the fuzzy similarity matrix S are spread in [0, 1], where 0 represents no similarity and 1 represents maximum similarity. In this study, we collected eight similarity matrices, one for each of the considered muscles, resulting in a large amount of data that entails a difficult interpretation. For this reason, in order to evaluate a separation between MS patients and healthy subjects, we decided to leverage the Fuzzy similarity approach and to use the granulated matrices as input for the classifier, as described in Sect. 5.

3.5

Classification Method

The Support Vector Machine (SVM) classifier [15] has been considered to realize a preliminary inspection of the processed data. SVM is a binary classifier whose goal is to find the best linear decision surface that separates the training features space. SVMs have high generalization capability because they can be extended to separate a space of non-linear input features. This classification method has been used in many different applications [16].

4 Results As previously discussed, to evaluate a separation between MS patients and healthy subjects, we used the fuzzy granulated matrices as input for a classifier, due to the huge number of features. Two machine learning approaches have been considered: Artificial Neural Network (ANN) and Support Vector Machine (SVM). The input dataset comprises 41 instances (21 control subjects and 20 MS patients) and the pattern consists of the 168 variables resulting from 3 features acquired from 8 muscles for each of the 7 phases (3  8  7). No other preprocessing operations were needed, because of the normalized-nature of the features values. The best results have been achieved using the SVM classifier with third order polynomial kernel. To avoid data overfitting, we used 5-fold cross-validation considering all 168 variables. As the dimension of the dataset is relatively small, we realized multiple tests to get more reliable results. The SVM approach yielded an average accuracy around 96%, showing the existence of a clear separation between the two input sets. The confusion matrix of the best SVM model is showed in Fig. 5, and the performance indexes are reported in Eqs. (9), (10) and (11):

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Fig. 5. Confusion Matrix of the best SVM model

TP þ TN ¼ 0:97 TP þ TN þ FP þ FN

ð9Þ

Sensitivity ¼

TP ¼ 0:95 TP þ FN

ð10Þ

Specificity ¼

TN ¼ 1:0 TN þ FP

ð11Þ

Accuracy ¼

However, the low number of instances in the input dataset suggests to further investigate these promising results.

5 Conclusion In this paper, we present a procedure that evaluates three features for each muscle involved in gait to summarize, quantify, and simplify the assessment of gait impairment in patients affected by Multiple Sclerosis. We aim at supporting physicians in identifying the rehabilitation treatment for a specific group of muscles, and in defining a personalized therapy for each patient. To this end, we extract a dataset consisting of the three features involved in gait, and we exploit SVM to separate healthy subjects and patients. Our method shows an average accuracy of 96%, proving the relevance of features. Nevertheless, future work will include a detailed investigation of our results in studies involving a larger group of subjects.

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References 1. Compston, A., Coles, A.: Multiple sclerosis. Lancet 372(9648), 1502–1517 (2008) 2. Shah, A.: Fatigue in multiple sclerosis. Phys. Med. Rehabil. Clin. N. Am. 20, 363–372 (2009) 3. Bevilacqua, V., Nuzzolese, N., Barone, D., Pantaleo, M., Suma, M., D’Ambruoso, D., Volpe, A., Loconsole, C., Stroppa, F.: Fall detection in indoor environment with kinect sensor. In: IEEE International Symposium on Innovations in Intelligent Systems and Applications (INISTA) Proceedings, pp. 319–324. IEEE (2014) 4. Gholami, F., Trojan, D.A., Kövecses, J., Haddad, W.M., Gholami, B.: Gait Assessment for Multiple Sclerosis. arXiv:1508.02405 (2015) 5. Pau, M., Coghe, G., Atzeni, C., Corona, F., Pilloni, G., Marros, G., Cocco, E., Galli, G.: Novel characterization of gait impairments in people with multiple sclerosis by means of the gait profile score. J. Neurol. Sci. 345, 159–163 (2014) 6. Bogale, M.A., Yu, H., Sarkodie-Gyan, T., Abdelgawad, A.: Characterization and quantification of gait deficits within gait phases using fuzzy-granular computing. J. Biomed. Sci. Eng. 5, 720–728 (2012) 7. Soens, P., Verhelst, W.: On split dynamic time warping for robust automatic dialogue replacement. Sig. Process. 92, 439–454 (2012) 8. Gavrila, D.M., Davis, L.S.: Towards 3-d model-based tracking and recognition of human movement: a multi-view approach. In: International Workshop on Automatic Face and Gesture Recognition, pp. 272–277 (1995) 9. Aach, J., Church, G.M.: Aligning gene expression time series with time warping algorithms. Bioinformatics 17(6), 495–508 (2001) 10. Schwartz, M.H., Rozumalski, A.: The gait deviation index: a new comprehensive index of gait pathology. Gait Posture 28(3), 351–357 (2008) 11. Beynon, S., McGinley, J.L., Dobson, F., Baker, R.: Correlations of the gait profile score and the movements analysis profile relative to clinical judgments. Gait Posture 32(1), 129–132 (2010) 12. Davis III, R.B., Õunpuu, S., Tyburski, D., Gage, J.: A gait analysis data collection and reduction technique. Hum. Mov. Sci. 10(5), 575–587 (1991) 13. Butterworth, S.: On the theory of filter amplifiers. Wirel. Eng. 7, 536–541 (1930) 14. Pedrycz, W., Gacek, A.: Temporal granulation and its application to signal analysis. Inf. Sci. Inf. Comput. Sci. 143, 47–71 (2002) 15. Cortes, C., Vapnik, V.: Support-vector networks. Mach. Learn. 20(3), 273–297 (1995) 16. Bevilacqua, V., Pannarale, P., Abbrescia, M., Cava, C., Paradiso, A., Tommasi, S.: Comparison of data-merging methods with SVM attribute selection and classification in breast cancer gene expression. BMC Bioinf. 13(7), S9 (2012)

HomeAssist: An Assisted Living Platform for Aging in Place Based on an Interdisciplinary Approach Charles Consel1,2 ✉ , Lucile Dupuy2, and Hélène Sauzéon2,3 (

1

)

Bordeaux Institute of Technology, 33400 Talence, France [email protected] 2 Inria, 33405 Talence, France {Dupuy,Helene.Sauzeon}@inria.fr 3 University of Bordeaux, 33405 Talence, France

Abstract. This paper presents HomeAssist: an assisted living platform aims to support aging in place. This platform was designed using a human-centered approach. It offers assistive services, addressing the main aspects of daily life: activities of daily living, home and user safety, and social participation. Home‐ Assist introduces key novel features: (1) it covers multiple aspects of daily life, addressing a variety of needs of older adults; (2) it provides customization mech‐ anisms, adapting assistance to the user’s abilities while preventing autonomy losses; (3) it relies on context awareness, delivering timely assistance; and, (4) it revolves around a unified user interface to achieve usability. All these features play a key role towards achieving high acceptance of HomeAssist and supporting autonomy effectively, as shown by our field study. Keywords: Human Factors · Aging in place · Pervasive computing · Field study

1

Introduction

To address the challenge of demographic aging, there is a growing interest for Assistive Technologies (AT) dedicated to aging in place. Today, ATs are regarded as one of the most promising ways to meet needs of older adults at home, particularly in the three domains sensitive to late senescence: everyday activities, including basic and instru‐ mental Activities of Daily Life (ADL) (e.g., reminding drug intake with a connected pillbox), safety at home (e.g., detecting falls with a wrist-worn fall detector), and social participation (e.g., relating to others with collaborative games) [1]. Unfortunately, the growing supply of ATs for aging in place does not translate into technology adoption by older adults [2, 3]. As a result, researchers in the field of Aging and Human Factors have investigated the factors affecting technology acceptance amongst the elderly popu‐ lation. According to the Senior Technology Acceptance Model [4], and previous related studies, three main factors are identified as barriers or assets of technology acceptance: (1) the characteristics of older persons (e.g., perceived needs, technological skills, medical conditions, etc.), (2) their environment (e.g., social support for using AT, living

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place, etc.), (3) the features of technology (e.g., hardware, interface accessibility, usability, etc.) [4, 5]. Despite considerable efforts for leveraging the knowledge on aging and human factors, several issues remain to be resolved [6]. A key issue is concerned with the silobased approach currently used in the development of both research and industrial ATs; that is, a single AT addresses a single task or need. This silo-based approach has many consequences. First, it gives rise to a challenge regarding the number of ATs that can be introduced, as the older adult requires more services to assist an increasing number of daily activities. Second, the heterogeneity of interfaces across technologies incurs an unrealistic cognitive load on older users for learning these technologies. Third, due to the intra- and inter-individual variability and evolution of needs, assistive technology support must be adaptable (i.e., providing a personalized set of services). In doing so, assistive technology support can account for spared abilities, thus avoiding the risks of functional losses elicited by the AT use. The fourth consequence, related to the silobased approach, is the lack of context awareness of assistive services. This situation results in services that deliver assistance irrespective of the actual person’s needs and context, potentially making assistance unsuited or even obstructive in daily life. The field of technology and aging has been pushed forward with the advent of Ambient-Assisted Living (AAL) where digital devices are spread everywhere to opti‐ mize and naturalize interactions between the individuals and their physical surrounding [7]. Basically, AAL consists of sensors (motion detectors, contact sensors, etc.) and actuators (connected door locks, smart plugs, notifications on mobile devices, etc.); it can be seen as a processing system with perception-action loop driven by software serv‐ ices supporting users to achieve specific goals, or to anticipate possible outcomes of their actions. AAL has the potential to integrate a range of technologies, products and services for promoting aging in place. Queiros et al. examined this promising approach by performing a systematic review of the AAL literature, analyzing a total of 1,048 studies [7]. They reported that only 10% of these studies were related to user issues (accessibility and usability, in particular), clearly revealing the technology-oriented approach of this new field of AT for older adults. Also, among the 13% of technologies with a practical purpose, only 0.04% (N = 6) has been tested in field trials. As already observed in a previous review [8], these field studies are reported as lacking empirical evidence of AAL efficacy, mostly due to the study designs with often small sample sizes, non-standardized measures (i.e., self-made measures), experimental home setting (rather than real homes), and an absence of a control group. The HomeAssist project aims to contribute to the field of AAL. It is designed to support aging in place with assistive services, addressing the main aspects of daily life: activities of daily living, home and user safety, and social participation. In doing so, HomeAssist introduces key novel features: (1) it covers multiple aspects of daily life, addressing a variety of needs of older adults; (2) it provides customization mechanisms, adapting assistance to the user’s abilities while preventing autonomy losses; (3) it relies on context awareness, delivering timely assistance; and, (4) it revolves around a unified user interface to achieve usability. These features play a key role to achieve high accept‐ ance of HomeAssist and supporting autonomy effectively, as shown by our field study.

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Outline. This paper is organized as follows. Section 2 presents the human-centered design of HomeAssist and its key components, namely, an open-ended catalog of assis‐ tive services, covering a range of user needs (Sect. 2.1), an infrastructure of devices and software services, supplying information to the assistive services (Sect. 2.2), an activity detection system, providing context awareness to assistive services (Sect. 2.3), and a notification system, accounting for older adults characteristics for user interactions (Sect. 2.4). Section 3 reports on the evaluation of HomeAssist. In particular, we assessed the sensitivity and reliability of the activity detection system (Sect. 3.1), the effectiveness and learnability of the notification system (Sect. 3.2), the user experience of HomeAssist (Sect. 3.3), and its efficacy (Sect. 3.4). Section 4 provides concluding remarks.

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Design of HomeAssist

HomeAssist was designed using a human-centered approach, driven by a needs analysis of target older adults and their caregivers, formal and informal. Additionally, a range of stakeholders in the aging domain were involved in the design process, including care‐ giving organization, municipalities, senior residences, and the French national retire‐ ment organization. Specifically, the design of HomeAssist included five key phases: needs analysis, requirements analysis, development of assistive applications, ergonomic evaluation, and benefits evaluation. 1. Needs analysis examined activities that are sensitive to age-related decline and essential for independent living. Additionally, capabilities of the target user popu‐ lation were gathered along such dimensions as cognitive functioning, sensorimotor abilities, and attitudes towards technology. 2. Requirements analysis identified goals related to independent living and assistive or compensation strategies to achieve them, inspired by the environmental support hypothesis, promoted by such researchers as Rogers and Morrow [9]. 3. Development of assistive applications addressed the needs analyzed earlier, while fulfilling the requirements. Assistive applications were developed in conformance to ergonomic standards specific to older adults. 4. Ergonomic evaluation of HomeAssist was performed to measure acceptability and user experience. 5. Benefits evaluation for the older user and their social environment was conducted using specific criteria: wellbeing of users and caregivers, as well as user autonomy. In this section, we first present the assistive services of HomeAssist. Second, we examine the infrastructure that is required to be deployed in a user’s home. Then, we focus on two important features of HomeAssist: an activity monitoring system for delivering context-aware assistance and its notification system for assisting the user. Both features are evaluated in Sect. 3.

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2.1 Assistive Services We conducted a needs analysis for aging in place, recruiting 525 older adults living in their home [10]. Additionally, we collected the needs for assistive technologies to support aging in place from 100 older participants and their caregivers [11]. We grouped the resulting needs into three domains of assistance: activities of daily living, user and home safety, and social participation. We selected a subset of needs and defined require‐ ments for each of them. This work led to the development of assistive applications. Let us present these applications according to the three domains of assistance. Activities of daily living are covered by applications that monitor tasks (meal prep‐ aration, self-care, dressing, etc.), report activity assessment to the user and/or caregiver, and remind appointments and other events. User and home safety are provided by applications that light a path to the bathroom at night, monitor the stove, and alert a caregiver in case of an unusual situation (e.g., no activity during the day). Social participation is addressed by a range of applications, including a simplified service of email, a service for video-conferencing, and services for leisure activities according to the user’s interests (gaming, news, reading, etc.). The HomeAssist applications reside in an extensible, online catalog, in the spirit of the ones for smartphones. In doing so, our platform offers a modular response to the needs of individual older adults and their caregivers in that they can select the specific applications that address the challenges of the user. Additionally, each application is configurable, allowing assistance to be further personalized. As a result, each participant has a unique setting of their assisted living platform. 2.2 Infrastructure Assistive applications rely on an infrastructure of devices and Web services deployed at the home of each user. Devices consist of sensors, monitoring user interactions with the environment, and actuators, allowing to perform actions. Sensors include contact sensors, motion detectors and smart plugs, which measure electricity consumption and can turn off/on a connected appliance. These devices are connected wirelessly to a gateway, which communicates with our server via the Internet. These devices are widely available, easy to configure, and low cost. Additionally, each home is equipped with two tablets. One tablet is stationary and is placed in a central location in the home. It is the main point of interaction between the assistive applications and the user; this so-called main tablet receives a notification when the user needs to be alerted by an assistive application regarding a particular situation. Otherwise, the main tablet turns into a digital frame, displaying photos (family, topics of interest), thus avoiding stigmatization. The second tablet is devoted to social participation and leisure. Besides devices, assistive applications leverage Web services such as a shared calendar, an email service, a weather service, etc.

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2.3 Activity Detection Aging in place critically relies on the functional status of an individual, as reflected by the way activities of daily living are performed. As a consequence, monitoring activities of daily living is essential to determine the autonomy of an older adult and the type and level of support that are needed to ensure their autonomy. To address this issue, we have developed and tested empirically a new approach, leveraging both the literature on the daily functioning of older adults, and sensor tech‐ nology [12]. Specifically, our approach uses results from geriatrics research showing that as older adults age their activities are increasingly organized according to a routine to optimize their daily functioning [13]. Consequently, the activities of an older adult can be verified with respect to their declared routines. Accurately detecting activities is an overarching feature of a platform for aging in place because it allows to deliver context-sensitive assistance to users. In particular, accurate activity detection prevents from notification fatigue, issued by assistive appli‐ cations monitoring user activities. Assistive applications remind the user of performing a task, only when it is missed. 2.4 Notification System We have designed and developed a notification system that exploits the preference of older adults for simple interactions and optimize their cognitive resources by using a multimodal coding of notifications (tones, shapes, colors, and text). All assistive appli‐ cations are required to interact with the user via either a critical or a non-critical notifi‐ cation, depending on the consequence of the situation. Each type of notification employs multimodal coding, as illustrated by Figs. 1 and 2, respectively displaying a critical and a non-critical notification.

Fig. 1. Critical notification

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Fig. 2. Non-critical notification

This approach makes it easier to discriminate between the notification types. Further‐ more, the user follows a dedicated procedure for each type of notification. Critical notifications (Fig. 1) use a loud volume and only disappear when the situation is resolved; it can contact a caregiver via a text message after a pre-defined period of time to seek for help. In contrast, non-critical notifications (Fig. 2) use a soft tone; they disappear after being displayed for a set period of time and get added to a list of unat‐ tended (non-critical) notifications. An example of such list is displayed in Fig. 3. This mechanism allows a user to disregard a notification if it occurred while they were performing another task. If the condition that raised a non-critical notification does not hold (e.g., the door of the fridge was closed), then this notification is suppressed from the list of unattended notifications.

Fig. 3. List of unattended notifications

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Evaluation of HomeAssist

We now present the evaluation of the HomeAssist platform along four dimensions: accuracy of the verification of activities, usability of our notification system, user expe‐ rience of our platform, and its efficacy. 3.1 Activity Verification Recall that our approach to verifying activities is driven by user knowledge, which guides the placement of sensors, tracking the execution of the declared routines. A routine formula gathers key parameters that determine whether an activity is performed. Parameters are derived from the user declarations; they may include an interval of time within which the user is scheduled to perform an activity and selected interactions with the environment are supposed to occur. For example, a user has breakfast between 7:00 am and 8:00 am, using a coffee machine and milk from the fridge among other interac‐ tions. Such parameters are used to calculate a score between 0 and 1. If the activity is not performed, the score is 0, 1 otherwise. We assessed our knowledge-based methodology to verify daily activities (meal preparation, bathing, and dressing) in the context of a field study, including four single participants, aged 83 years on average (SD = 7.89) [12]. It was shown that our approach was as sensitive and reliable as an ergonomist, according to Signal Detection Theory analysis for non-parametric data (Fig. 4). Sensitivity (A’) Response Bias (B’’D) Meal preparation 1.00 0.00 Bathing 0.94 1.00 Dressing 0.93 0.39 Scores obtained by HomeAssist with the ergonomist responses as ground truth (hit, correct rejection, false alarm and miss). A’ measures the sensitivity to correctly discriminate the presence or the absence of a stimulus. This measure is contained between 0 (extremely low sensitivity) and 1 (extremely high sensitivity). B’’D measures the response bias: from -1 (tendency to respond yes and produce false alarms) to 1 (tendency to respond no and miss stimuli).

Fig. 4. A′ and B″D scores for the three ADL (meal preparation, bathing and dressing)

As illustrated by Fig. 4, both meal preparation and getting dressed were accurately detected by HomeAssist, whereas bathing was well discriminated but sometimes missed. The accuracy of our system provides a solid basis on which to develop a range of assistive applications such as one that reminds daily activities to users. 3.2 Notification System We have evaluated the effectiveness and learnability of our notification system by submitting usage scenarios in our three domains of assistance to 15 older adults, aged 81 years (SD = 6.19) [14]. These participants lived alone and were installed HomeAssist in their home. They were evaluated every 1.5 months over a period of 6 months. Results,

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displayed in Fig. 5, show that participants achieved effectiveness from the start of the experiment and reached an expert level after 4.5 months, regardless of the type of notification (critical or non critical).

Effectiveness scores range from 0 to 3. Diamond for critical notifications / Square for non-critical ones. Fig. 5. Evolution of effectiveness

Time is measured in seconds. Diamond for critical notifications / Square for non-critical ones. Fig. 6. Evolution of learnability

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Regarding learnability, as shown in Fig. 6, we observe that at six weeks of technology use, participants take more time to respond to a critical notification, compared to a noncritical one. Nevertheless, at six months of use, participants perform equally well, regardless of the type of notification. 3.3 User Experience of HomeAssist We measured user experience of HomeAssist four times over a period of 6 months during which our platform were deployed at the home of 15 cognitively healthy older adults

User experience dimensions

User experience scores from -3 to 3. Four measures (at 1.5, 3, 4.5 and 6 months) represented by 4 shades of blue. Fig. 7. Evolution of user experience

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having moderate autonomy losses [14]. Five dimensions of user experience were used: ergonomic quality, hedonist quality, appealingness, safety perception, and social influ‐ ence. It leveraged Hassenzahl’s tool “attrakdiff.de” [15]. Results are displayed in Fig. 7 and show that HomeAssist is globally well experi‐ enced by users. In particular, ergonomic quality and safety perception are two dimen‐ sions that increase over time for most participants. Specifically, 93.30% of HomeAssist users considered the ergonomic quality of our platform between satisfactory and very satisfactory. Furthermore, they found the assistive services provided to them as useful, pleasant, appealing, non-stigmatizing (sometimes rewarding) and reinforcing safety. 3.4 Efficacy of HomeAssist We analyzed the efficacy of HomeAssist as a tool to support aging in place [16]. This analysis was conducted by comparing equipped participants with their control counter‐ parts using a self-determination scale [17]. All the participants were cognitively spared (MMSE > 23 [18]) but physically frail with functional losses from mild to moderate [19, 20]. As shown in Fig. 8, participants equipped with HomeAssist perceived a significant increase in their daily autonomy, self-regulation, and empowerment. These improve‐ ments are important because self-determination has been shown to be directly linked to

A. Autonomy; B. Self-regulation; C. Empowerment; D. Self-realization T0: pale blue, T6: dark blue Fig. 8. Evolution of self-determination dimensions (from Dupuy et al. [16]))

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well-being of older adults: the more an individual perceives themselves as being self determined, the better their health and well being (e.g., [21]).

4

Conclusion

We have presented our preliminary results showing that HomeAssist is positively expe‐ rienced by users, who demonstrated efficacy in using it. This gives insights on the ergo‐ nomic value of HomeAssist, such as its high usability and high acceptance. Furthermore, our field study revealed that users of our platform were more self-determined, resulting in improved autonomy and well-being. Indeed, the perceptions of behavioral autonomy, self-regulation, self-realization and psychological self-empowerment were increased in the equipped participants. Another aspect of the efficacy of HomeAssist concerns the caregiver-carereceiver dyad. More precisely, we assessed the caregiver burden for supporting the older adult in their everyday functioning. Results revealed that the caregiver burden has signifi‐ cantly increased for control participants over time, but remained unchanged in the equipped participants [22]. These results are promising and encouraging, suggesting that long-term adoption of HomeAssist is within reach and that it may contribute to prevent functional decline of older adults with mild to moderate loss of autonomy. In turn, these benefits should prevent the caregiver burden to increase. However, to be generalized, these results need to be strengthened. To do so, we recently launched a large-scale study of HomeAssist, gathering more than one hundred older adults. This research initiative gathers key stakeholders of the domain of aging, including municipalities, French national retirement organizations, companies, and a European agency. It should contribute to formulate health claims (prevention and compensation) regarding HomeAssist that could be guaranteed to users and prescribers.

References 1. Rashidi, P., Mihailidis, A.: A survey on ambient-assisted living tools for older adults. IEEE J. Biomed. Health Inform. 17(3), 579–590 (2013) 2. Czaja, S.J., Charness, N., Fisk, A.D., Hertzog, C., Nair, S.N., Rogers, W.A., Sharit, J.: Factors predicting the use of technology: Findings from the center for research and education on aging and technology enhancement (CREATE). Psychol. Aging 21(2), 333–352 (2006) 3. Chen, K., Chan, A.: A review of technology acceptance by older adults. Gerontechnology 10(1), 1–12 (2011) 4. Chen, K., Chan, A.H.S.: Gerontechnology acceptance by elderly Hong Kong Chinese: a senior technology acceptance model (STAM). Ergonomics 57(5), 635–652 (2014) 5. Peek, S.T.M., Wouters, E.J.M., van Hoof, J., Luijkx, K.G., Boeije, H.R., Vrijhoef, H.J.M.: Factors influencing acceptance of technology for aging in place: a systematic review. Int. J. Med. Inform. 83(4), 235–248 (2014) 6. Fisk, A.D., Rogers, W.A., Charness, N., Czaja, S.J., Sharit, J.: Designing for Older Adults: Principles and Creative Human Factors Approaches. CRC Press, Boca Raton (2012)

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7. Queirós, A., Silva, A., Alvarelhão, J., Rocha, N.P., Teixeira, A.: Usability, accessibility and ambient-assisted living: a systematic literature review. Univers. Access Inf. Soc. 14(1), 57– 66 (2015) 8. Reeder, B., Meyer, E., Lazar, A., Chaudhuri, S., Thompson, H.J., Demiris, G.: Framing the evidence for health smart homes and home-based consumer health technologies as a public health intervention for independent aging: a systematic review. Int. J. Med. Inform. 82(7), 565–579 (2013) 9. Morrow, D.G., Rogers, W.A.: Environmental support: an integrative framework. Hum. Factors J. Hum. Factors Ergon. Soc. 50(4), 589–613 (2008) 10. Aguilova, L., Sauzéon, H., Balland, E., Consel, C., N’Kaoua, B.: Grille AGGIR et aide à la spécification des besoins des personnes âgées en perte d’autonomie. Rev. Neurol. 170(3), 216–221 (2014) 11. Dupuy, L., Sauzéon, H., Consel, C.: Perceived needs for assistive technologies in older adults and their caregivers. In: ACM WomENcourage 2015 (2015) 12. Caroux, L., Consel, C., Dupuy, L., Sauzéon, H.: Verification of daily activities of older adults: a simple, non-intrusive, low-cost approach. In: ACM ASSETS 2014 (2014) 13. Bouisson, J.: Routinization preferences, anxiety, and depression in an elderly french sample. J. Aging Stud. 16(3), 295–302 (2002) 14. Consel, C., Dupuy, L., Sauzéon, H.: A unifying notification system to scale up assistive services. In: ACM ASSETS 2015 (2015) 15. Hassenzahl, M., Burmester, M., Koller, F.: AttrakDiff: Ein Fragebogen zur Messung wahrgenommener hedonischer und pragmatischer Qualität. In: Mensch and Computer, pp. 187–196. Vieweg + Teubner Verlag (2003) 16. Dupuy, L., Consel, C., Sauzéon, H.: Self determination-based design to achieve acceptance of assisted living technologies for older adults. Comput. Hum. Behav. 65, 508–521 (2016) 17. Wehmeyer, M.L.: Self-determination and individuals with severe disabilities: re-examining meanings and misinterpretations. Res. Pract. Persons Severe Disabil. 30(3), 113–120 (2005) 18. Folstein, M.F., Folstein, S.E., McHugh, P.R.: Mini-mental state: a practical method for grading the cognitive state of patients for the clinician. J. Psychiatr. Res. 12(3), 189–198 (1975) 19. Lawton, M., Brody, E.: Assessment of older people: self-maintaining and instrumental activities of daily living. Gerontologist 9, 179–186 (1969) 20. Fried, L.P., Tangen, C.M., Walston, J., Newman, A.B., Hirsch, C., Gottdiener, J., Seeman, T., Tracy, R., Kop, W.J., Burke, G., et al.: Frailty in older adults evidence for a phenotype. J. Gerontol. A Biol. Sci. Med. Sci. 56(3), M146–M157 (2001) 21. Ekelund, C., Eklund, K.: Longitudinal effects on self-determination in the RCT “Continuum of care for frail elderly people”. Qual. Ageing Older Adults 16(3), 165–176 (2015) 22. Dupuy, L., Froger, C., Consel, C., Sauzéon, H.: Evaluation of everyday functioning benefits from a long-term use of an assisted living platform for aging in place: a pilot field study amongst frail community-dwelling older adults and their caregivers (2017)

Healthcare Application for Foreigners Living in China Syed Attiqur Rehman, Zhe Chen ✉ , and Muhammad Haris (

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School of Economics and Management, Beihang University, Xueyuan Road no. 37, Beijing 100191, Haidian District, China [email protected]

Abstract. The language barrier brings communication difficulties between inter‐ national patients and healthcare providers in China, possibly resulting in serious health risk. This paper design a healthcare app which could increase convenience in getting healthcare service, reduce communication gap between patients and healthcare providers. An interview was conducted for international students and Chinese doctors. With the help of interview results, a healthcare app for foreigners living in China was developed. Keywords: Ergonomics and usability · m-Health · Language barrier

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Introduction

According to President of the Center for China and Globalization number of foreignborn nationals in China has increased drastically, about 50% from 2000–2013 and now they account for 0.5% of total population. Most of the foreigners living in China are unable to speak Chinese or only speak a few Chinese words. The living conditions of foreigners are severely affected by the language barrier. Being able to get appropriate healthcare service is a basic need of happy and healthy life for any individual. Language ability such as interpreting of oral communications and translating written materials play an important role in patient safety for foreigners [1]. In recent years many researchers have tried to use mobile phones as a tool for moni‐ toring various chronic health symptoms in patients [2]. The number of m-health appli‐ cations is increasing rapidly, and most developers are choosing Apple’s iOSdevices [3]. M-health brings cheap healthcare to users while preventing illness and helping patients manage and treat chronic diseases [4]. M-health apps can prove to be very useful in healthcare communication, especially by reducing communication gap between patients and Healthcare providers. The objective of this paper is to design an ergonomic healthcare app which could help foreigners describe their medical conditions with healthcare providers. Although target users for presented app model are foreigners living in China, who lack adequate proficiency of Chinese language, people who lack proficiency in official regional language can also adopt this model.

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Literature Review

2.1 Language Barrier in Healthcare Miscommunications in healthcare do not attract enough consideration previously, but the increased size in immigrant population means addressing this issue is necessary and important. A study has been conducted to show language barrier in healthcare and perform the quantitative and qualitative investigations [5]. Communication errors occur when either healthcare practitioner or patient use their second language. This study was conducted in English and Chinese Speaking Patients. The results of this Study suggest that understanding language barrier between patients and practitioners is very crucial for adequate treatment. Increased Psychological stress in patients even health risk can occur due to the language barrier. Lack of communication caused mistakes such as delay in treatment, wrong diagnosis, unnecessary repeated visits and escalation to emergency cases. Another study was done in Europe found language barriers lead to seriously risky situations in the hospital [6]. Foreigners living in China face similar situations in which they cannot explain their health problem effectively to doctors because of lack of Chinese language proficiency, even locating and navigating a good hospital can be difficult for some foreigners. The author of the paper “Language Barriers in Healthcare [7]” has sketched such situation and explained how hard it could be for people with limited Chinese proficiency to get proper medication in China. In fact, miscommunication can cause Healthcare practi‐ tioners to prescribe wrong medication and consequently result in fatal health risks. 2.2 Mobile Health in China Mobile health or m-health can be defined as the use of wireless technology to deliver health services and information on mobile communication devices such as mobile phones, PDAs, Smartphones, monitoring devices, e-book readers, and iPods [8]. Mobile health apps have the potential to bring health risk prevention and prove to promote a healthier lifestyle among the general population. The use of Mobile health apps has been to collect important clinical data and community health data. It also includes delivery of vital information to professionals, researchers, and patients. Data from sensor based mobile apps can be used to collect real-time monitoring of patients [9]. In China, m-Health is large growing market with the potential to change traditional market structure [10]. China’s m-Health market is rapidly growing with increase with the rate of 29% in 2014 [11]. The market size is expected to reach ¥12.5 billion (approx‐ imately US $1.90 billion) in 2017 [12]. Despite being such big market, it still lacks mobile application which addresses issues faced by foreigners, such as navigating to the good hospital and communicating their problems with doctors. 2.3 Usability and Ergonomics of Mobile Health Applications Human Factors and Ergonomics (HFE) need more considerations while designing Health Information Technology (HIT) [13]. Usability of the system is much more than

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the interface; it also includes compatibility of system behavior with users’ need [14]. Users are more inclined towards timesaving features in an app, and they identify them to be valuable if it’s simple and intuitive to use [15].

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Objectives

The main objective of the study survey was to develop an ergonomic design for mobile healthcare application for international students at Beihang University. The specific aims of the study include are. • To collect and analyze information on challenges and experiences of international students in accessing health services at the campus. • To explore established health and fitness app users’ experiences using a qualitative interview approach. Many apps are developed for a target audience of healthcare workers, including physicians, nurses, and assistants. These apps are more sophisticated, with medical terminology and functions, and not easily navigable by non-health professionals. This paper provides simple and intuitive features for ease of use by applying ergonomics design principles to design and develop a mobile phone app customized for international students at Beihang University in Beijing, China.

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Methodology

A survey of international students and Chinese doctors was conducted. The aim of this survey was to know whether students want a mobile health app, if so then what features would they expect from such app. The study also investigated the technological solutions to health issues and the current infrastructure for medical monitoring and communica‐ tion processes faced by international students in Beihang University. The survey involved a sample population of 100 international students of Beihang University and ten medical practitioners from the University health clinic. The survey and interviews were conducted coupled by administering a questioner to the respondents. Later data was collected and analyzed. The data from survey helped understand students’ percep‐ tion of mobile healthcare apps. 4.1 Survey In this survey questions were asked from health practitioners and international students in an interview. 100 international students and ten health practitioners were chosen as a sample population. Students are from various nationalities with no to basic Chinese language skills. Along with interview questions, we also asked for any suggestion they had to offer. First charts were created for Students and doctors both. This was to understand each individuals’ personality, understanding and use of technology and what will motivate them to use a certain mobile application. In Fig. 1, one of the doctors’ personality,

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technology usage and motivations to use mobile apps. Similarly, Fig. 2 shows person‐ ality and preferences of one of the student.

Age 55 Sex Female Professional Doctor Married LocaƟon Beijing Language Chinese

Fig. 1. Shows an example of the chart which contains personality, preferred channels, technology level, etc. for one of health practitioner in the sample population.

Age 20 Sex Male Professional Student Single LocaƟon Shanghai Language English Fig. 2. Shows an example of the chart which contains personality, preferred channels, technology level, etc. for one of a student in the sample population.

Survey Results. All hundred students admitted that they face communication problems with doctors because of language barriers. Even students who could speak basic Chinese had communication errors. Same results were true for health practitioners also, according to them even if foreigners speak some Chinese they cannot understand specific medical terms. From population size, 92 percent of foreigners and 94 percent health practitioners like the idea of healthcare app. All respondents expected the app to have a translation feature along easy navigation and simpler interface. Although users can use other translation apps available on the market that will require them to use multiple apps. The ergonomically suitable solution would be to include translation feature along with other features in the same app. 4.2 Design of Healthcare Application (BUAA+) The design of app provides instant access to hospital database and doctors. It also has an offline database of common conditions. The user can navigate through the app to

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narrow down to his/her condition and in a comment box add specific details about his/her medical condition. Finally, all of the users’ inputs is accumulated in text and translated into Chinese. Translated information can give doctor brief introduction to patients’ condition. Also, speech to text translation is added to the app so the user can just speak and provided information about the medical condition and it will be translated into Chinese text. Basic Architecture of BUAA+ app is shown in Fig. 3.

Fig. 3. Architecture of BUAA+ application

The user can sign up into the app so information can be stored in the system. This way user can input information once and access it multiple times. Another time-saving feature is that nearest hospitals can be searched instantly from signup screen. Tapping on “Nearest hospitals” button takes the user to another activity where hospitals are listed in order of their distance, shown in Fig. 4. For the convenience of the user, we also wanted to add “Make appointment” feature, but this could not be possible. Because in July 2016 Chinese government released legislation which bans mobile health apps to provide appointment services to patients [10]. Speech input button was added to the

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main screen as well. The function of this button would be to take user’s speech as input and translate into Chinese than display output as Chinese text. This would allow the user to just tap on the button and speak about their medical condition.

Fig. 4. Home/Main activity & Nearest Hospital search screen

5

Discussion

The aim of this research was to design an app which could make it easier for foreigners facing language barrier to get medical treatment. After the survey, we added features which respondents suggested. But this research has some shortcomings like. • Making an appointment and being able to explain the problem is key in this situation but what about the further questions the doctor might ask? An interpret would still be required in such situation. • There will inevitably be adoption issue for this app. Although health practitioners in our survey sample showed confidence in our design population size was not big enough to say for sure. • Usability of this design needs to be tested, and further research needs to be done to realize if these features would work or not. These questions can be motivation for future research.

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Conclusion

The language barrier between Healthcare providers and patients can cause serious Health risks. Usually, miscommunication due to language barrier occurs when Health‐ care providers or patients are can’t effectively speak the same language. This paper explores this problem and proposes a solution using m-health. Mobile healthcare appli‐ cations are being used on a regular basis by patients and doctors. M-health can be can also be used to reduce language barrier among patients and healthcare practitioners. We propose an ergonomically design application which a user can use to locate hospitals and this application can also translate patient’s speech to local language which can then be easily understood by the doctor. Although proposed solution is not enough to solve this problem it lays the foundation for further research which can improve this idea of using m-health to eliminate communication gap in healthcare. Acknowledgments. This study was funded by a National Natural Science Foundation China grant 73038101 and a Social Science Foundation Beijing grant 16YYC040.

References 1. Quan, K.: The high costs of language barriers in medical malpractice. National Health Law Program (2010) 2. Klasnja, P., Pratt, W.: Healthcare in the pocket: mapping the space of mobile-phone health interventions. J. Biomed. Inform. 45, 184–198 (2012) 3. Liu, C., Zhu, Q., Holroyd, K.A., Seng, E.K.: Status and trends of mobile-health applications for iOS devices: A developer’s perspective. J. Syst. Softw. 84, 2022–2033 (2011) 4. Durfee, T., Becherer, K., Chen, P.L., Yeh, S.H., Yang, Y., Kilburn, A.E., Lee, W.H., Elledge, S.J.: Mobile communications for medical care: a study of current and future healthcare and health promotion applications, and their use in China and elsewhere. Genes Dev. 7, 555 (2011) 5. Meuter, R.F.I., Gallois, C., Segalowitz, N.S., Ryder, A.G., Hocking, J.: Overcoming language barriers in healthcare: a protocol for investigating safe and effective communication when patients or clinicians use a second language. BMC Health Serv. Res. 15, 371 (2015) 6. van Rosse, F., de Bruijne, M., Suurmond, J., Essink-Bot, M.-L., Wagner, C.: Language barriers and patient safety risks in hospital care. A mixed methods study. Int. J. Nurs. Stud. 54, 45–53 (2016) 7. Saha, S., Fernandez, A.: Language barriers in healthcare. J. Gen. Intern. Med. 22, 281–282 (2007) 8. Garcia-Gomez, J.M., de la Torre-Diez, I., Vicente, J., Robles, M., Lopez-Coronado, M., Rodrigues, J.J.: Analysis of mobile health applications for a broad spectrum of consumers: a user experience approach. Health Inform. J. 20, 74–84 (2014) 9. Wu, J.H., Wang, S.C., Lin, L.M.: Mobile computing acceptance factors in the healthcare industry: a structural equation model. Int. J. Med. Inform. 76, 66–77 (2007) 10. Hsu, J., Liu, D., Yu, Y.M., Zhao, H.T., Chen, Z.R., Li, J., Chen, W.: The top Chinese mobile health apps: a systematic investigation. J. Med. Internet Res. 18, 1–10 (2016) 11. Market share of mobile health market in China. https://www.statista.com/statistics/328927/ mobile-health-market-scale-in-china/

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12. Xiaohui, Y., Han, H., Jiadong, D., Liurong, W., Cheng, L., Xueli, Z., Haihua, L., Ying, H., Ke, S., Na, L., West, D., Bleiberg, J.: mHealth in China and the United States: How Mobile Technology is Transforming Healthcare in the World’s Two Largest Economies (2014) 13. Aspden, P.: Institute of Medicine (U.S.). Committee on Data Standards for Patient Safety: Patient Safety: Achieving a New Standard for Care. National Academies Press, Washington DC (2004) 14. Beuscart-Zéphir, M., Borycki, E., Carayon, P., Jaspers, M.W., Pelayo, S.: Evolution of human factors research and studies of health information technologies: the role of patient safety. IMIA Yearb. Med. Inform. 8, 66–77 (2013) 15. Mendiola, M.F., Kalnicki, M., Lindenauer, S.: Valuable features in mobile health apps for patients and consumers: content analysis of apps and user ratings. JMIR mHealth uHealth 3, e40 (2015)

Train4OrthoMIS Online Course as a Manner of Improving Ergonomics in Orthopaedic Surgery ( ) Joanna Bartnicka1 ✉ , Alicia Piedrabuena2, Raquel Portilla2, 3 Juan Luis Moyano-Cuevas , José Blas Pagador3, Francisco M. Sánchez-Margallo3, Peter Augat4, Dariusz Michalak5, and Jarosław Tokarczyk5

1

Institute of Production Engineering, Silesian University of Technology, Gliwice, Poland [email protected] 2 Instituto de Biomecánica de Valencia, Valencia, Spain {alicia.piedrabuena,raquel.portilla}@ibv.upv.es 3 Jesús Usón Minimally Invasive Surgery Centre, Cáceres, Spain {jmoyano,jbpagador,msanchez}@ccmijesususon.com 4 Institute of Biomechanics, Trauma Center Murnau, Murnau am Staffelsee, Germany [email protected] 5 KOMAG Institute of Mining Technology, Gliwice, Poland {dmichalak,jtokarczyk}@komag.eu

Abstract. The paper presents the research outcomes on ergonomic needs among orthopaedic surgeons and the way of improving working conditions while performing orthopaedic surgeries. The international survey was conducted among orthopaedic surgeons in Europe, that revealed physical ailments of surgeons like neck pain, thoracic and lumbar pain, musculoskeletal stress, fatigue in the legs and feet as well as mental fatigue or headache. In turn to the most important deficiencies in ergonomics area are: awkward body postures, having to stand, the position and height of the operating table. Taking this into account it is proposed an open and international online training course for improving ergonomics features. The new approach of this course is demonstrated by basing on ICT functionalities and combination of specific course features like: possible short duration of training; contents focus on practice and based on knowledge visualization; mobile and open access to training or knowledge verification based on students’ preferences. Keywords: Ergonomics · Working conditions improvement · Orthopaedic procedures · Procedural knowledge · International E-learning course · Train4OrthoMIS

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Introduction

Orthopaedics is one of the essentially domains in surgery. This results from the raising orthopaedic disorders magnified specifically by civilization factors like sedentary life‐ style, extension of lifetime, growing automotive industry and associated to this auto‐ motive accidents etc. Together with the needs in orthopaedic field it is observed the © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_16

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development of methods and procedures in orthopaedic surgeries. One of the new and still improving approaches is minimal invasive surgery (MIS) or reducing the size of skin incisions. Such direction of surgical development is positive, especially for patients, because of better efficiency and effectiveness of surgery, better cosmetics effects or lower risk of infections, but it could cause certain problems for medical staff both for surgeons and scrub nurses. These problems concern ergonomic failures what can lead to fatigue or even musculoskeletal disorders of orthopaedic surgeons and scrub nurses [1–3]. Particularly, the preliminary international survey which was conducting within 2015 on 41 orthopaedic surgeon from Europe (including 1 individual from other countries than Europe) confirmed the necessity of improving ergonomics in operating room (OR) while performing orthopaedic surgeries. Simultaneously they indicate such physical problems while performing surgeries like: neck pain, thoracic and lumbar pain, stiff neck, fatigue and musculoskeletal stress, fatigue in the legs and feet and mental fatigue or headache, see Fig. 1.

Fig. 1. The most common health problems of orthopaedics.

Regarding aspects that could affect non-ergonomic posture during surgical practice they are mainly: patient positioning, static posture surgeon, regulatory ranges and char‐ acteristics of the table and type of surgery. In turn to the most important deficiencies in ergonomics area are: awkward body postures, having to stand, the position and height of the table inadequate surgery [4]. Taking into account the challenge that is improving ergonomics in orthopaedic surgeries there was formulated the work problem as follows: how to create and imple‐ ment unify ergonomics standards while performing orthopaedic surgical procedures to make them more comfortable and safe for surgeons? In order to answer this research question, the aim of the study was defined as developing the specification and content for creating the unified online training course on ergonomics directed to orthopaedic professionals regardless the country they live and work. The assumption of this online

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training course is to include ICT (information and communication technology) func‐ tionalities to make the training mobile and interactive. The name of this course is Train4OrthoMIS, the acronym of the international project “Online Vocational Training course on ergonomics for orthopaedic Minimally Invasive Surgery” that has been funded with support from the European Commission.

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Materials and Methods

2.1 Methodological Model The aim of the study forced the development of certain methodology which is composed of four stages. Their detailed description is shown in the Fig. 2. In particular, the main issues from the marked area covering second and third stages are the subject matter of this article.

Fig. 2. Detailed description of methodology.

Specifically, these stages should be prepared in such a way that they could be useful within the work on preparation of e-learning course with the use of ICT solutions.

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2.2 ICT Factors in Train4OrthoMIS Ergonomics Course The concept of Information and Communication Technologies is greatly wide and covers all informatics and communication products and services. In particular, these technologies include processing, gathering and information transmitting technology in electronic form [5]. Considering ICT functionalities and their potentially contribution for improving the effectiveness and utility of the Train4OrthoMIS course there were recognized the essen‐ tial factors determining assumptions for tasks within second and third stages in the methodology. They are following: • unified communications which means the possibility of integrating different forms of real-time with non-real-time communication services, e.g. instant messaging (chat), e-mail, SMS, • unlimited access to e-learning contents by stationary and mobile devices, • the high quality of information which is defined by such factors as: accuracy, time‐ liness, completeness, relevance and coherence [6] as well as readability, understand‐ ability, • variable forms of e-training materials which is associated to the size and form of the individual elements of learning objects making them reused and allowing them for combinations according to the contextual situation and the type and content of the training. In the literature, such elements are referred to as the Reusable Learning Objects (RLO) [7], E-learning Objects (ELO) or Shared Content Objects (SCO). The examples of RLOs can be video or audio, interactive games and quizzes in virtual working conditions, course modules, animations, graphics, websites, PDF files, documentation, and other elements that are designed to spread certain resources, e.g., in the form of a lesson based on the Internet [8]. Taking into account these factors there were formulated assumptions for the tasks of highlighted stages from the methodology, Table 1. According to the formulated assumptions the learning contents meets the require‐ ments for ICT functionalities mentioned before. Particularly all of recommended points indicated in the Table 1 will be implemented into e-Platform being simultaneously a Platform for exchanging knowledge or messages in different configurations: tutor – student, student – student and tutor – tutor, in real-time or non-real-time mode. In the same time the assumptions are formulated to meets the students’ preferences diagnosed within survey. They are specifically: possible short duration of the training; contents focus on practice and based on knowledge visualization; mobile and open access to the training; knowledge verification based on single choice tests and interactive quizzes.

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Table 1. Assumptions for ICT based definition of a Train4OrthoMIS course Task

Assumptions

2nd STAGE - definition of a VET training curriculum Definition of There is clearly defined three groups of learning outcomes: knowledge, skills, learning outcomes competences that will designate the boundaries for ELOs, their representation forms and self-evaluation methods The general training‘s structure definition consists of organizational and technical Definition of general training’s assumptions structure Organizational assumptions: The substantive course topics are ordered and linked together into greater objects according to diagnosed ergonomic needs and defined learning outcomes. Simultaneously they form ELOs creating modules and sessions. The number and size of ELOs is adjusted to total time for the course: 50 h Technical assumptions: ELOs are consisted of variable forms of knowledge representations. The selection of the ELOs’ form depends on the type of knowledge, where there are assumed two types of knowledge: procedural or declarative. The procedural knowledge is a knowledge answering to the question “how” while, the declarative knowledge means its possession in the specific area, the so-called knowledge “that” [9]. The main form for declarative knowledge is text, and for procedural knowledge are video or audio, interactive games and quizzes in virtual working conditions, course modules, animations, graphics etc All of formats of ELOs are readable for standard parameters of stationary and mobile devices Modules and Modules description consists of substantive assumption which is compatible with the sessions description defined learning outcomes. The basic ergonomics issues are gathered in one module and is directed to both hip and spine surgeons. More specific problem areas considering certain type of surgeries are described in differed ELOs and are addressed separately for certain group of surgeons (spine and hip) Definition of selfDefinition of self-evaluation methodology consists of organizational and technical evaluation assumptions methodology Organizational assumptions: self-evaluation work is present within each stage of the course. Self-evaluation test must be performed before starting the next module. There are two different types of self-evaluation tests: (a) free tests without impact on finishing course mark; (b) exam that have impact on finishing course mark Time restriction is obligatory only for the exam Technical assumptions: tests have variable forms for free tests and exam and are adjusted to most student preferences. All of formats of tests are readable for standard parameters of stationary and mobile devices 3rd STAGE - Development of the e-learning course based on the developed contents Development of Training contents are developed according to 2nd stage assumptions. Particularly session contents declarative knowledge is formulated according to literatures, facts, interviews etc. and own knowledge repositories; declarative knowledge is formulated according to video registrations of real surgical procedures and ergonomic analysis. Within whole contents there is used unequivocal vocabulary. All material contents have electronic forms Development of Self-evaluations module are developed according to 2nd stage assumptions. self-evaluations Particularly self-evaluation topics are compatible with defined learning outcomes. module Within test contents there are used unequivocal vocabulary compatible with session contents

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Results

Based the methodological structure and assumptions the implementation of ergonomics standards was performed obtaining as a result the accomplishment of all tasks described within second and third stages. First of all, the detailed description of Curriculum docu‐ mentation was prepared taking into account the recommended three groups of learning outcomes: knowledge, skills and competences. This document allows future students to recognize the ergonomics aspects get to know of which they should make them able to implement ergonomic rules in their orthopaedic practice. Figure 3 presents a fragment of the documentation on the background of the assumptions for ICT (see Table 1).

Fig. 3. A fragment of curriculum for Train4OrthoMIS course including the description of learning outcomes

The description of learning outcomes is reflected in the training structure. Consid‐ ering the theoretical and practical aspects of the training, the course is divided into four modules. Each module is divided into sessions which correspond to ELOs and have duration of about 2 to maximum 6 h. The Fig. 4 shows a general scheme summarizing the course structure with emphasis on the type of knowledge dominating (marked by bigger size of font in the scheme) with creation of certain ELOs. It should be highlighted that the great part of training contents is prepared based on procedural knowledge what corresponds to the surgeons’ expectations. Particularly the procedural knowledge reflects certain type of activities and resources needed to perform orthopaedic surgery of hip or spine taking into account ergonomic criteria. However, there were four phases of developing training materials: • First phase was video registration of real surgeries and/or surgeon’s body segment angles measurement,

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Fig. 4. General content and structure of Train4OrthoMIS course

• Second phase was ergonomic analysis based on video materials in such areas as: ergonomics body posture, ergonomics of surgical instruments, operating room layout, workflow and surgical team cooperation. The ergonomic tools assessment were mainly based on observational methods like OWAS, RULA, REBA, computer aided ergonomic assessment with se use of virtual environment 3DSSPP, Anthropos ErgoMAX and CAPTIV system. • Third phase was developing general (for MIS in orthopaedics) and specific (for certain type of surgical procedure) recommendations. • Four phase was notation of training materials with the use of visual representation like static and dynamic graphics. • For instant, in the Fig. 5 the training materials development is presented taking into account the registration, body segment angles identification and virtual working environment creation. All interactive ELOs are focused on the transfer of procedural knowledge what is the most important value to surgical practice. In the same time, such a way of knowledge representation is universal and intuitive for human perception making the e-training a practice tool for improving professional skills.

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Fig. 5. The procedure of training materials development

Another way of procedural knowledge representation in learning process is the graphical based surgical workflow analysis. The basis for developing workflow is video material of surgical course. There is presented an example of using workflow represen‐ tation in analysis ergonomics and effectiveness of surgical procedure. In the Fig. 6 there is presented two general sections in the graphical representation of workflow: 1. Specification of job elements, inter alia: procedure stages, tolls handling, operational activities, disruptions, deficiencies, 2. The processing of job elements showed by use of charts. All job elements are synchronized with video materials what allows for identification of problems in range of work organization and communication within surgical team as well as their causes and consequences. The characteristic elements describing surgical workflow and influencing ergo‐ nomics as well as effectiveness of procedure are: • Disruptions like: improper lighting of the operative field and the need for its correc‐ tions; viability of a pump suction and flushing, which consequently can lead to replace with a new one; • Passive action of surgeon operator results from such causes like: waiting for surgical instruments, waiting for materials etc. • Deficiencies like: lack of materials, devices etc.

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Fig. 6. Graphical representation of workflow while performing hip replacement

• Cases, where surgeon operator covers activities normally performed by an assistant, • Cases, where surgeon operator must correct activities performed by an assistant. The last part of e-learning course is knowledge verification of student. The ways for this process are based on electronic self-evaluation tools. The assumption was formu‐ lated that the test forms will be adjusted to the future students’ preferences. For this reason, the survey was conducted on 184 respondents. The most preferred way of knowledge verification is traditional method i.e. single choice. However, more sophis‐ ticated quizzes can be a supplementary way of self-knowledge evaluation, especially within daily work on e-Platform.

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Conclusions

Train4OrthoMIS course is the professional knowledge platform directed to orthopaedic surgeons the aim of which is to improve their practice in ergonomics area. The need of developing the course results from the occupational hazard in MIS surgery and simul‐ taneously a lack of ergonomics contents within standard high education system. This problem is common for surgeons population regardless the country they practice. Hence, the recognition of ergonomic problems while performing orthopaedic MIS on international level was the opportunity to complete formative e-learning content according to real surgeons’ needs and implement ergonomics standards in orthopaedic surgery. ICT tools are here the accurate solution allowing the wide audience of ortho‐ paedic practitioners an access to ergonomic knowledge. In the same time the currently results showed that certain ICT functionalities, like making declarative and practical

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knowledge available and explicit by interactive graphical representations or online transferring knowledge in line student – academic tutor, can be successfully used for improving practical skills of surgeons in ergonomic area and help them to make working condition more user friendly. Acknowledgments. This work has been done under the project “Online Vocational Training course on ergonomics for orthopaedic Minimally Invasive Surgery”. This project has been funded with support from the European Commission. This communication reflects the views only of the author, and the Commission cannot be held responsible for any use which may be made of the information contained therein.

References 1. Berguer, R.: Surgery and ergonomics. Arch. Surg. 134, 1011–1016 (1999) 2. Davis, W.T., Fletcher, S.A., Guillamondegui, O.D.: Musculoskeletal occupational injury among surgeons: effects for patients, providers, and institutions. J. Surg. Res. 189, 207–212 (2014) 3. Van Veelen, M., Nederlof, E., Goossens, R., Schot, C., Jakimowicz, J.: Ergonomic problems encountered by the medical team related to products used for minimally invasive surgery. Surg. Endosc. 17, 1077–1081 (2003) 4. Bartnicka, J., Piedrabuena, A., Portilla, R., Moyano-Cuevas, L., Pagador, J.B., Augat, P., Tokarczyk, J., Sánchez Margallo, F.M.: International E-learning for assuring ergonomic working conditions of orthopaedic surgeons: first research outcomes from Train4OrthoMIS. Int. J. Educ. Pedag. Sci. 3(1), 358–363 (2016). http://www.istshare.eu/ict-technologieinformacyjno-komunikacyjne.html 5. DeLone, W.H., McLean, E.R.: The DeLone and McLean model of information systems success: a ten-year update. J. Manag. Inf. Syst. 19, 9–30 (2003) 6. Valderrama, R.P., Ocan, L.B., Sheremetov, L.B.: Development of intelligent reusable learning objects for web-based education systems. Expert Syst. Appl. 28, 273–283 (2005) 7. Muzio, J.A., Heins, T., Mundell, R.: Experiences with reusable E-learning objects. From theory to practice. Internet High. Educ. 5, 21–34 (2002) 8. Ten Berge, T., van Hezewijk, R.: Procedural and declarative knowledge. An evolutionary perspective. Theory Psychol. 9, 605–624 (1999) 9. Ten Berge, T., van Hezewijk, R.: Procedural and declarative knowledge. An evolutionary perspective. Theor. Psychol. 9, 605–624 (1999)

Quality Care and Patient Safety: Strategies to Disclose Medical Errors Jawahar (Jay) Kalra1,2 ✉ and Ashish Kopargaonkar1 (

1

2

)

Department of Pathology and Laboratory Medicine, College of Medicine, University of Saskatchewan, Saskatoon, SK, Canada [email protected] Royal University Hospital, Saskatoon Health Region, 103 Hospital Drive, Saksatoon, SK S7N 0W8, Canada

Abstract. In any health care process, adverse events resulting from errors are inevitable. Failure to inform the patient of adverse events caused by a medical error compromises the autonomy of the patient. Disclosure of an adverse event is an important element in managing the consequences of a medical error. Physi‐ cians should seek to disclose medical errors to patients and their families on both ethical and pragmatic grounds. Effective communication between health care providers, patients and their families throughout the disclosure process is integral in sustaining and developing the physician patient relationship. Keywords: Adverse events · Medical error · Patient safety · Medical error disclosure

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Introduction

Recently there has been a groundswell of response from the public, the health care community, and government agencies to address the issue of medical errors. There are reports in the medical literature that indicate every patient subjected to medical inter‐ vention may not necessarily face a beneficial outcome [1–3]. The healthcare processes are constantly under the radar for causing harm to patients. Medical errors and adverse events (AE’s) are primarily responsible for this harm. The research in hospitalized populations has consistently revealed high rates of adverse events. These medical errors, which may occur at every level of the system, are diverse in nature and common. The Institute of Medicine (IOM) report, To Err Is Human: Building a Safer Health System, goes to the extent of terming medical errors a public health risk [4]. Adverse events have been widely classified as preventable and unpreventable, though some suggest that a preventable adverse event constitutes an error [5, 6] and a subset of adverse events can be judged preventable, though it has never been rigorously measured [7]. The rate of adverse events in hospital patients from studies worldwide varies from 3.7% in New York to 11% in United Kingdom (UK) and 16.6% in Australian hospitals [1–3]. In Canada, two studies give rates of AEs as 5% and 7.5% [8, 9] and “Health Care in Canada 2004” report states that about 5.2 million Canadians have experienced a preventable © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_17

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adverse event either in themselves or in a family member [10]. There are many reasons for errors occurring in today’s health care system. Though, in defense, it must be mentioned that health care in general is not comparable to any other high-risk sector, like aviation or the nuclear industry [11]. Reason (1990) noted that health care is deliv‐ ered in an environment with complex interactions among many variables, like the disease process, the medical staff and equipment, the infrastructure, organizational poli‐ cies and procedures [12]. Thus, even small errors can result in larger system conse‐ quences. Unlike many other industries, health care sectors do not enjoy the luxury of well-defined processes. The health care professionals function in a dynamic environment and some health care services, such as the emergency department (ED), where aggres‐ sive interventions are often necessary, suffer the most from these liabilities. In EDs, many key decisions aremade in split seconds, and are frequently based on little or no prior medical information. It is therefore not surprising that the rates of error are the highest in such challenging environments [13]. The questions unanswered include - How to prevent errors and what should we do when errors occur. The promotion of patient safety may require greater integration of concepts evolving from cognitive psychology, human and systems re-engineering, educational programs, professional development, bioethical viewpoints, and legislative actions. In this review, we give a brief critical overview of literature on medical error disclosure and various policies implemented by health care agencies in Canada and around the world.

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Medical Error: Severity and Statistics

The IOM report estimated that 44,000–98,000 deaths occur every year in the USA because of medical error [4]. Brennan et al. (1991) published the findings of their land‐ mark Harvard Medical Practice (HMP) Study. This was a population-based study on medical injuries due to interventions. In this study, the authors reviewed medical charts of over 30,000 patients admitted to New York hospitals in 1984 and estimated that 3.7% of admissions resulted in an injury that prolonged their hospital stay or resulted in disa‐ bility at the time of discharge. Estimates exist claiming that AEs occur in one third of hospital admissions. Moreover, 3.5 billion dollars per year are spent due to in hospital adverse drug events (ADE), which comprise roughly 26% of all preventable AEs according to one estimate [14] (Table 1). The Quality of Australian Health Care (QAHC) Study quoted a rate of 16.6% of admissions resulting in adverse events [2]. In terms of seriousness of injury, the HMP and QAHC studies differed widely. The HMP study reported approximately 14% of the injuries to be ultimately fatal and approximately 3% causing permanent disability, whereas the QAHC study estimated death in nearly 5% of injuries and permanent disa‐ bility in 14% of patients who suffered from iatrogenic injuries. The HMP study was followed up with a similar study from the states of Utah and Colorado [15]. The Utah and Colorado study employed a representative sample of around 15,000 non-psychiatric discharges and found adverse events in about 3% of hospitalizations in each state.

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Table 1. Rates of adverse outcomes in health care. Study Brennan et al. [14] Wilson et al. [2] Thomas et al. [15] Vincent et al. [3] Baker et al. [9]

Year Data source Rate of adverse outcomes 1991 30,121 records from New York 3.7% hospitals 1995 14,000 Admissions in New South 16.6% Wales and Australia 2000 15000 non psychiatric discharges 2.9% in Utah and Colorado 2001 1014 records from 2 London 10.8% hospitals 2004 3745 hospital charts from 25 7.5% Canadian hospitals

Vincent et al.(2001), using a similar methodology of retrospective record review of patient charts in British hospitals, reported that approximately 11% of patients in their study experienced an adverse event [3]. In New Zealand hospitals, an adverse event was recorded in at least 10.7% of the 1326 medical records [16]. Schioler et al. (2001) studied the incidence of adverse events in Denmark, and reported that 9% of all admissions were associated with adverse events. Though the adverse events recorded in the study caused a prolonged hospital stay, most resulted in minor and transient disabilities, while a few deaths or permanent disability were recorded [17]. In Canada, studies conducted by Baker et al. (2004) and Foster et al. (2004) detected that 7.5% and 12.7% of hospitalized patients were affected by an adverse event, respec‐ tively, and they deemed 2.8% and 4.8% of these adverse events to have been preventable, respectively. In Baker et al.’s study, the most common causes of medical error were delayed diagnoses of cancer and heart disease; drug overdoses; communication errors; and operative errors. According to Forster et al., the principle causes were erroneous delivery of medication; operative complications; and nosocomial infections [8, 9].

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System and Human Factor Influence on Errors

The complexity of the health care delivery system may be primarily responsible for escalated error rates. A large proportion of the blame lies not on individual fallacy, but system complexities. The second IOM report (2001), crossing the Quality Chasm: A New Health System for the 20th Century, suggests that better reporting of systemic errors will lead to better system design thus minimizing medical errors. The report further goes on to elaborate that reducing risk and ensuring safety require greater atten‐ tion to systems that help prevent and mitigate errors [18]. It is suggested that little can be achieved by way of patient safety unless safer systems are designed around human factors. Health care systems should be held accountable, rather than focusing solely on individual culpability. It is, therefore, suggested that health care errors be viewed from a systems perspective to help bring about effective changes in delivering safe health care [18].

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It has been suggested that physicians tend to overestimate their ability to function under conditions of stress, like fatigue and high anxiety [19]. This attitude of health care professionals, of assuming flawless performance even at times of extreme stress, may prove to be their undoing. Health care professionals are only human and are as suscep‐ tible to error as any others are, but there seems to be a prevailing consensus that perfec‐ tion is their forte and mistakes from them are unacceptable. Apart from the system factors, impaired human cognition leads to erroneous deci‐ sions. The study of medical error may have greater association with cognitive sciences rather than medical sciences. Cognitive skills are closely knit in medical decisionmaking. The technological advances in medicine and research have outpaced develop‐ ments in cognitive decision-making and have not been complementary. However, inno‐ vative training strategies in cognitive skills development through strategic management simulation techniques have been proposed [20]. Leape (1994) suggested that in clinical situations that do not follow a normal pattern, and require rule-based or knowledgebased solutions, humans are biased to search for a “pre-packaged solution” [5]. Use of modern information technology tools to improve quality and patient safety to aid in complex medical decision-making may be a feasible approach [21, 22].

4

Education and Professional Development

Developing a culture in which medical professionals are less tolerant of medical errors should be the norm in healthcare. Hughes (1971) noted that medical professionals are concerned with the actual process of medical care; results of the process are the only concern of the client. The need for an educational program at all levels of health care emerges from one necessity, and that is enhanced quality care and patient safety. Educa‐ tion in this field is essential for health care professionals to further hone their scientific skills and ultimately improve their professional practice. Education about these errors, and their preventability, could provide us with some of the basic interventional approaches that can reduce errors and improve quality [23]. We have previously suggested the implementation of quality care grand rounds as a forum for discussion and evaluation of medical errors in a guilt-free and secure envi‐ ronment aimed at achieving enhanced patient safety [24]. We have also suggested and implemented a ‘no fault’ model to encourage voluntary anonymous reporting [11], and an educational component targeting all levels of laboratory professionals including technologists and residents.

5

Error Reporting Systems

The reporting of adverse events and medical errors was one of the principal recommen‐ dations of the IOM report [4]. The IOM intended that such reporting of critical incidents would increase information sharing and enhance opportunities for learning from these mistakes. The success of reporting systems depends largely on removal of the disin‐ centives associated with reporting. Assurance of anonymity and confidentiality are the

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two most important incentives for health care professionals to report critical incidents. Non-punitive reporting is the foremost requirement in a successful reporting system. Certain other voluntary systems like the Joint Commission on Accreditation of Healthcare Organization (JCAHO) sentinel event reporting program, MedMARx program of the United States Pharmacopeia, National Nosocomial Infection Survey of the Centers of Disease Control and prevention of medication error reporting program of the Institute of Safe Medical Practices are already being practiced with success [6, 25]. In Canada, there currently exists a Canadian Patient Safety Institute (CPSI), who performs a coordinating and leadership role across the health care sector by promoting patient safety amongst various stakeholders such as health care partners, patients, their families and the general public [1]. Though research on error disclosure is limited, there is little evidence to suggest that the phenomenon of not disclosing errors to patients has changed over the years. Blendon et al. (2002) reported that only 30% of the patients having suffered an error acknowl‐ edged to having been informed about the error by their physician [26]. Not disclosing an error during the course of their patient care may amount to compromising their informed consent. Health care professionals should routinely disclose error to the patient and their family. Error disclosure should occur at the right time, when the patient is in a stable condition and in the right setting [27]. Sometimes, challenging situations arise if errors are trivial and may ultimately not cause any harm to the patient. In such instances, Hebert et al. suggested to carry out appropriate disclosure unless evidence exists that the patient may not want to be told about the error. A study conducted by Tamblyn et al. (2007) indicated that doctors who lack good communication skills are more likely to have complaints filed against them than those who communicate well with their patients [28].

6

Medical Errors: How, What and When to Disclose

The individual who should disclose the information to the patient is the one most appro‐ priate to handle the discussion as identified by the concurrence of the medical team that has worked with the patient. As a rule, however, disclosure errors as promptly as possible, while taking into account the patient’s medical and emotional condition. Disclosure is a process; the discloser must avoid speculating as to how the error occurred and simply state what the facts at the time. It is also important to follow up the disclosure with a second conversation with the patient, preferably conducted by the same individual that performed the original disclosure. Inform the patient of all available results of the adverse event investigation, as well as the progress of any new medical treatment. Give an opportunity to the patient and family to discuss the issue with other relevant health care professionals, who can offer additional information as well as a second opinion on the matter. Moreover, all previously unanswered queries – due to a lack of contextual knowledge on the discloser’s part needs to be responded to as well [29]. In 2001 the US Joint Commission on Accreditation of Healthcare Organizations (JCAHO) announced an “unanticipated outcome” policy that demands disclosure of a critical event by the provider or the institution [25]. In general, the Joint Commission

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recommends that the doctor should conduct the disclosure, though on occasion some other member of the team will be more suitable. New Zealand has adopted a no-fault compensation policy that entitles patients to payments from the Accident Compensation Corporation if they are injured due to unintended medical errors or any other adverse consequence that results from their medical treatment [30]. Medical professionals pay insurance premiums to fund these payments [31]. In 2002, a committee of the Australian Council for Safety and Quality in Health Care offered an approach to achieving open and honest communication with patients after an adverse event, addressing the interests of consumers, healthcare professionals, managers and organizations. The unique aspect of the Australian standard is the integration of disclosure with a risk management anal‐ ysis and investigation of the critical event. The National Health Service (NHS) in United Kingdom (UK) in 2003 declared a ‘duty of candour’, whereby doctors and managers must inform a patient of an act of negligence or omission that causes harm [32]. This scheme offers the patient a package in the form of remedial care, apologies and monetary compensation without the need for litigation. The affected patients, if they accept the compensation package, waive their right to litigate [32]. The Royal College of Physicians and Surgeons of Canada in 2002 called for health‐ care systems to promote disclosure on safety issues to all partners including patients (NSCOS, 2002), but no uniform Canadian guidelines on the subject are yet in place. Reviewing nationwide practices on adverse event disclosure, we found that just a few licensing bodies had ratified policies for disclosure and discussion of negative outcomes during patient care. The College of Physicians and Surgeons of Saskatchewan requires the physician to disclose any adverse events and errors to the patient or his or her repre‐ sentative as soon as possible [33]. The College of Physicians and Surgeons of Manitoba requires the physician to avoid all speculations and state plain facts as known at the time [34]. In 2003, after lengthy deliberation, the College of Physicians and Surgeons of Ontario approved a policy that made disclosure of harm to patients a standard of practice [35], even in circumstances when such disclosure may result in a complaint or a malpractice insurance claim. A special aspect of the Ontario College policy is the guide‐ line for medical trainees (i.e. students or residents), who are advised to report an adverse event either to their supervisor or to the ‘most responsible physician’. The policy also specifies that the patient is free to refuse discussion of the event. The College of Physi‐ cian and Surgeons of Newfoundland and Labrador enacted a disclosure policy in 2006, emphasizing that a disclosure is not an admission of fault or liability. The College in Nova Scotia developed a disclosure policy two years later, and initiated a quality assur‐ ance program to compliment the policy [36]. In Canada, there is nothing in the nature of the US Joint Commission initiative, making disclosure of adverse events a require‐ ment for hospital accreditation. The absence of laws, federal or provincial, mandating adequate disclosure of an adverse event to the patient is a key area of concern.

7

Conclusions: Disclosure a Standard Practice in Healthcare

Full information of the medical error, should not be the only premise for disclosure, nor should it only be used to serve the purpose of patient safety. These ideas and the intention

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of using medical errors disclosure as a means to reduce costs, can displace the importance of medical error disclosure as an important tool to improve the quality of healthcare [37]. Development of well-defined patient safety initiatives based on a solid evidence base and systematically designed interventions will be more likely to give the best results in improving the quality of health care. A change in the patient safety culture is required to perceive errors as an outcome of the system rather than the fault of an individual. A patient safety incident requires the attention to focused on the needs of the patient both physical and emotional. The medical profession needs to debate regarding culture of medicine as a barrier for disclosure rather than the environment of malpractice and litigation after disclosure of medical errors [38]. Hence it is important for healthcare institutions to commit their resources to support the patient, physician and other hospital staff involved in the error [39]. To Quote the Australian Commission on Safety and Quality in Healthcare “health service organizations should create an environment in which all staff are: encouraged and able to recognize and report adverse events; prepared through training and education to participate in open disclosure; supported through the open disclosure process” [40]. Efforts need to be directed for assessment of the effec‐ tiveness of interventions used for reduction in medical errors and enhancing patient outcomes. Only then, will there be increase in accountability towards the disclosure and prevention of medical errors in the future and trigger a change in the provision of healthcare. Although disclosure guidelines exist, yet Canada does not have a nationwide uniform medical error disclosure policy. The provinces in Canada have initiated initia‐ tives towards medical error disclosure; these initiatives remain confined to the provinces due to the absence of a nationwide policy and raises the question on implementation and accountability. A “Non-Fault” model may seem to be a solution to increase error reporting without the fear of litigation; however, a well-defined policy needs to be initi‐ ated to avoid lack of accountability and digressing from issues of providing quality care. Various factors including ethical, effective communication between the patient and the physician, team based approach to raise the bar in the delivery of care and overall quality improvement in the process of care [41, 42]. Improving the process of healthcare is not a mandate for physicians alone; it is a collective effort of the healthcare institutions, policy makers and patients to contribute in making the process of medical error disclo‐ sure, comfortable, transparent, and a learning opportunity for everyone involved to deliver quality healthcare.

References 1. Brennan, T.A.: The institute of medicine report on medical errors—could it do harm? Mass Med. Soc. 342, 1123–1125 (2000) 2. Wilson, R., Runciman, W.B., Gibberd, R.W., Harrison, B.T., Hamilton, J.D.: Quality in Australian health care study. Med. J. Aust. 164(12), 754 (1996) 3. Vincent, C., Neale, G., Woloshynowych, M.: Adverse events in British hospitals: preliminary retrospective record review. BMJ 322(7285), 517–519 (2001) 4. Kohn, L., Corrigan, J., Donaldson, M.: To err is human: building a safer health system. Natl. Acad. Sci. Inst. Med. 6 (2002) 5. Leape, L.L.: Error in medicine. JAMA 272(23), 1851–1857 (1994)

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6. Leape, L.L.: Reporting of adverse events. N. Engl. J. Med. 347(20), 1633 (2002) 7. Hayward, R.A., Hofer, T.P.: Estimating hospital deaths due to medical errors: preventability is in the eye of the reviewer. JAMA 286(4), 415–420 (2001) 8. Forster, A.J., Asmis, T.R., Clark, H.D., et al.: Ottawa Hospital Patient Safety Study: incidence and timing of adverse events in patients admitted to a Canadian teaching hospital. Can. Med. Assoc. J. 170(8), 1235–1240 (2004) 9. Baker, G.R., Norton, P.G., Flintoft, V., et al.: The Canadian Adverse Events Study: the incidence of adverse events among hospital patients in Canada. Can. Med. Assoc. J. 170(11), 1678–1686 (2004) 10. Gagnon, L.: Patient safety: medical error affects nearly 25% of Canadians. CMAJ Can. Med. Assoc. J. 171(2), 123 (2004) 11. Kalra, J., Collard, D.: Medical error: a need for an educational program (2002) 12. Reason, J.: Human Error. Cambridge University Press, Cambridge (1990) 13. Pham, J.C., Aswani, M.S., Rosen, M., et al.: Reducing medical errors and adverse events. Annu. Rev. Med. 63, 447–463 (2012) 14. Brennan, T.A., Leape, L.L., Laird, N.M., et al.: Incidence of adverse events and negligence in hospitalized patients: results of the Harvard Medical Practice Study I. N. Engl. J. Med. 324(6), 370–376 (1991) 15. Thomas, E.J., Studdert, D.M., Burstin, H.R., et al.: Incidence and types of adverse events and negligent care in Utah and Colorado. Med. Care 38(3), 261–271 (2000) 16. Davis, P., Lay-Yee, R., Schug, S., et al.: Adverse events regional feasibility study: indicative findings (2001) 17. Schiøler, T., Lipczak, H., Pedersen, B.L., et al.: Incidence of adverse events in hospitals. A retrospective study of medical records. Ugeskr. Laeger 163(39), 5370–5378 (2001) 18. Richardson, W.C., Berwick, D.M., Bisgard, J., Bristow, L., Buck, C., Cassel, C.: Crossing the Quality Chasm: A New Health System for the 21st Century. Institute of Medicine, National Academy Press, Washington, DC (2001) 19. Helmreich, R.L.: On error management: lessons from aviation. BMJ Br. Med. J. 320(7237), 781 (2000) 20. Satish, U., Streufert, S.: Value of a cognitive simulation in medicine: towards optimizing decision making performance of healthcare personnel. Qual. Saf. Health Care 11(2), 163–167 (2002) 21. Kushniruk, A.W.: Analysis of complex decision-making processes in health care: cognitive approaches to health informatics. J. Biomed. Inform. 34(5), 365–376 (2001) 22. Bates, D.W., Gawande, A.A.: Improving safety with information technology. N. Engl. J. Med. 348(25), 2526–2534 (2003) 23. Hughes, E.C.: The Sociological Eye: Selected Papers. Transaction Publishers, New Brunswick (1971) 24. Kalra, J., Saxena, A., Mulla, A., Neufeld, H., Qureshi, M., Sander, R.: Medical error and patient safety: a model for error reduction in pathology and laboratory medicine. Clin. Invest. Med. 26, 732–733 (2003) 25. Saufl, N.M.: JCAHO’s patient safety standards. J. PeriAnesth. Nurs. 17(4), 265–269 (2002) 26. Blendon, R.J., DesRoches, C.M., Brodie, M., et al.: Views of practicing physicians and the public on medical errors. N. Engl. J. Med. 347(24), 1933–1940 (2002) 27. Hébert, P.C., Levin, A.V., Robertson, G.: Bioethics for clinicians: 23. Disclosure of medical error. Can. Med. Assoc. J. 164(4), 509–513 (2001) 28. Tamblyn, R., Abrahamowicz, M., Dauphinee, D., et al.: Physician scores on a national clinical skills examination as predictors of complaints to medical regulatory authorities. JAMA 298(9), 993–1001 (2007)

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29. Donaldson, M.S., Corrigan, J.M., Kohn, L.T.: To Err is Human: Building a Safer Health System, vol 6. National Academies Press (2000) 30. Paterick, Z.R., Paterick, B.B., Waterhouse, B.E., Paterick, T.E.: The challenges to transparency in reporting medical errors. J. Patient Saf. 5(4), 205–209 (2009) 31. Davis, P., Lay-Yee, R., Fitzjohn, J., Hider, P., Briant, R., Schug, S.: Compensation for medical injury in New Zealand: does “no-fault” increase the level of claims making and reduce social and clinical selectivity? J. Health Polit. Policy Law 27(5), 833–854 (2002) 32. Dyer, C.: NHS staff should inform patients of negligent acts. BMJ Br. Med. J. 327(7405), 7 (2003) 33. Kalra, J., Kalra, N., Baniak, N.: Medical error, disclosure and patient safety: a global view of quality care. Clin. Biochem. 46(13–14), 1161–1169 (2013) 34. Kalra, J., Massey, K.L., Mulla, A.: Disclosure of medical error: policies and practice. J. R. Soc. Med. 98(7), 307–309 (2005) 35. Borsellino, M.: Disclosure of harm to be standard of practice. Med. Post 39(11) (2003) 36. Gaulton, C.: Nova scotia public reporting-serious patient safety events? Advancing patient safety and quality? (2014) 37. Liang, B.A.: A system of medical error disclosure. Qual. Saf. Health Care 11(1), 64–68 (2002) 38. Gallagher, T.H., Waterman, A.D., Garbutt, J.M., et al.: US and Canadian physicians’ attitudes and experiences regarding disclosing errors to patients. Arch. Intern. Med. 166(15), 1605– 1611 (2006) 39. Waterman, A.D., Garbutt, J., Hazel, E., et al.: The emotional impact of medical errors on practicing physicians in the United States and Canada. Joint Comm. J. Qual. Patient Saf. 33(8), 467–476 (2007) 40. Guillod, O.: Medical error disclosure and patient safety: legal aspects. J. Public Health Res. 2(3), e31 (2013) 41. Kalra, J.: Medical error disclosure: a point of view. Pathol. Lab. Med. Open J. 1(1), e1–e3 (2016) 42. Wallis, K.: New Zealand’s 2005 ‘no-fault’ compensation reforms and medical professional accountability for harm (2013)

Human Factors and Employee Health

Effect of Walking upon Fatigue Due to Monotonous Work Kousuke Aramaki1(&) and Hiroshi Hagiwara2 1

2

Graduate School of Information Science and Engineering, Ritsumeikan University, Noji Higashi, Kusatsu, Shiga, Japan [email protected] College of Information Science and Engineering, Ritsumeikan University, Noji Higashi, Kusatsu, Shiga, Japan [email protected]

Abstract. The concept that exercise can alleviate physical fatigue is called active rest. However, whether active rest can alleviate mental fatigue remains unknown. Therefore, the aim of this study was to determine the effects of exercise on relaxation. The results show that both before and after performing a tracking task, increases were seen in “Sleepiness”, “Difficulty maintaining attention and concentration”, and “Lack of motivation” on the Roken Arousal Scale (RAS), and in the high-frequency (HF) component of heart rate variability, whereas decreases were seen in “Activation” on the RAS and in the alpha attenuation coefficient (AAC). These findings suggest that the tracking task caused fatigue in the participants. Differences were identified between before and after walking and sitting. Walking decreased “Sleepiness”, “Difficulty maintaining attention and concentration”, and “Lack of motivation”, and increased “Activation” on the RAS. By contrast, sitting did not change any of these factors. Walking increased, whereas sitting decreased the AAC, and high-speed walking led to greater increases than low-speed walking. The HF component decreased for all tasks. We therefore concluded that walking counteracts fatigue caused by monotonous work more effectively than sitting. Keywords: Electrocardiography Monotonous work




Electroencephalography




Walking




1 Introduction With the progress of informatization and globalization, modern society has become a 24-hour society, which has placed a greater burden on employees through more working hours and an increased quantity of information processing. According to a “Comprehensive Survey of Living Conditions”, it is clear that over 60% of people feel uneasiness, discomfort, and stress [1]. The increase in stress owing to the longer working hours and disrupted life rhythms associated with a 24-hour society is a major factor in decreased concentration and work efficiency. In such situations, it is important to quickly and effectively alleviate stress and improve work efficiency by improving the quality of rest. The concept that exercise can improve physical fatigue is referred to as active rest. However, whether active rest can improve mental fatigue remains unknown. © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_18

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Therefore, the aim of this study was to determine the effects of exercise on relaxation. Physiological changes were evaluated by electroencephalography (EEG) and electrocardiogram (ECG) measurements.

2 Experimental Methods 2.1

Participants and Experimental Instruments

Twelve healthy, non-medicated college students (9 men, 3 women; 20–22 years old) participated in the present study. All students provided written informed consent prior to participation, and refrained from excessive eating and drinking the night before the experiment and from prolonged or strenuous exercise on the morning of the experiment. An EEG recorder (EEG-1100; Nihon Koden, Tokyo, Japan) was used for EEG and ECG measurements. The mounting position of the EEG recorder is shown in Fig. 1.

A1

Fp1

z

Fp2

F7

F3

Fz

F4

F8

T3

C3

Cz

C4

T4

T5

P3

Pz

P4

T6

O1

A2

O2

Fig. 1. Schematic showing the mounting position of the electroencephalography (EEG) recorder. The placement of the scalp markers is shown on the left. The markers were placed according to the international 10–20 system. Recordings were obtained from electrodes C3, C4, O1, O2, A1, and A2. The mounting position of the electrocardiogram (ECG) is shown on the right. ECGs were taken using the 3-point lead system.

All statistical analyses were performed using the SPSS statistical software package (version 20; IBM SPSS Statistics, Tokyo, Japan) and MATLAB software (MathWorks Inc., Natick, MA, USA). Skin cream was applied to the skin of the participants before attaching the electrodes in order to reduce impedance.

2.2

Experimental Procedure

The experimental protocol is shown in Fig. 2. The experimental protocol was performed using alpha attenuation test (AAT) specific activity (eyes closed [30 s], eyes open [30 s]  3) for 3 min, followed by a 30-min monotonous task, a second 3-min

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Fig. 2. Schematic of the experimental design. The exercise comprised three different conditions (rest, low-speed walking, and high-speed walking).

AAT, a 10-min relaxation exercise, and a final 3-min AAT. One cycle lasted 49 min. The Roken Arousal Scale (RAS) was used to assess the participants before and after measurements and between exercises and mental loads. One cycle of the experiment was conducted daily. Finally, the EEG and ECG findings from all participants were evaluated.

2.3

Monotonous Task (UniMove)

Tracking tasks, called “UniMove”, in which a moving target constantly traces a path in the form of the number 8 on a monitor, were used for the monotonous tasks. Participants tracked the target using a mouse with their dominant hand. This task was designed to cause fatigue. We used tracking errors and tracking error variance to evaluate performance on the tracking task. We calculated tracking errors following Formula 1, where X and Y are the position coordinates of the target, and x and y are the position coordinates of the cursor. Position coordinate data were acquired at a sampling rate of 12 Hz. EðtÞ ¼

2.4

qffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffiffi ðX  xÞ2  ðY  yÞ2

ð1Þ

Exercise (Walking)

For the exercise task, we used low- and high-speed walking. For comparison, we also took measurements while participants were sitting in a chair. Walking speed was assessed using the Rating of Perceived Exertion (RPE) method. The feeling of a physical load differs among individuals, so we used the RPE to define the load criteria. Low-speed walking was defined as “really easy” and high-speed walking as “somewhat hard”. The participants’ walking speeds are shown in Table 1.

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K. Aramaki and H. Hagiwara Table 1. Participants’ walking speeds

Subject number No. 1 No. 2 No. 3 No. 4 No. 5 No. 6

Low-speed (km/h) 1.60 2.00 1.50 2.00 1.50 1.00

High-speed (km/h) 4.50 5.50 5.00 5.60 4.50 4.00

Subject number No. 7 No. 8 No. 9 No. 10 No. 11 No. 12

Low-speed (km/h) 2.50 1.00 1.50 2.20 1.50 2.00

High-speed (km/h) 5.00 4.00 4.50 5.80 4.70 5.00

3 Analytical Methods 3.1

Roken Arousal Scale (RAS)

The RAS is a psychological evaluation method for quantifying the degree of fatigue and alertness. The RAS provides a quantitative index of the following six states: “Sleepiness”, “Activation”, “Relaxation”, “Strain (tension)”, “Difficulty maintaining attention and concentration”, and “Lack of motivation”. The six states are scored based on answers to two similar questions about each state. The mean score of the two similar questions is defined as the state value [2].

3.2

Alpha Attenuation Coefficient (AAC)

We calculated the AAC from the AAT. When a participant is quiet and has their eyes closed, but are in an alert state, alpha waves appear in EEGs recorded from the parietal and occipital regions. The amount of alpha waves decrease when the eyes are open and when the participant is sleepy. Moreover, if the participant is in a state of activation and concentration, large differences between the times when the eyes are open and when they are closed are apparent. By contrast, if the participant is sleepy, only small differences between the times when the eyes are open and when they are closed are apparent. The power spectrum for the alpha waves was 8–13 Hz, as calculated based on fast Fourier transform after noise suppression from the EEG recordings with high-pass (0.1 Hz), low-pass (120 Hz), and band-stop (57–63 Hz) filters. The ratio of average alpha-wave power with the eyes closed (30 s  3) to average power with the eyes open (30 s  3) was defined as the AAC, which was used as a quantitative index for evaluating the degree of alertness. The AAC was analyzed using EEG signals obtained from O1–A2. A high AAC indicates a high degree of awakening, whereas a low AAC indicates a low degree of awakening [3, 4]. AAC ¼

Average power eyes closed Averrage power eyes opened

ð2Þ

Effect of Walking upon Fatigue Due to Monotonous Work

3.3

175

High-Frequency (HF) and Low-Frequency (LF) Components

We calculated the HF and LF from the ECG. HF and LF components were defined as those with center frequencies of 0.15–0.4 Hz and 0.04-0.15 Hz, respectively. HF provides an index of the degree of parasympathetic system activity, while the LF/HF ratio provides an index of the degree of sympathetic system activity. Heart rate variability was calculated based on R-R interval variation and comparisons of changes in HF and the LF/HF ratio before and after the tasks.

4 Results 4.1

RAS

Figure 3 shows the average RAS values. When comparing values for the six states before and after the monotonous task, increases were seen in “Sleepiness”, “Difficulty maintaining attention and concentration”, and “Lack of motivation”, whereas decreases were seen in “Activation”. Regarding before and after exercise, values for “Sleepiness”, “Difficulty maintaining attention and concentration”, and “Lack of motivation” were lower after walking than after sitting in a chair. In addition, “Relaxation” was decreased after high-speed walking, and “Activation” was more increased after walking than after sitting.

4.2

AAC

The mean AAC values are shown in Fig. 4. Decreases were seen in AAC values for all conditions when comparing before and after the monotonous task. No changes were seen in AAC values while sitting in a chair when comparing before and after exercise; however, increases were seen after walking. In particular, AAC values were more increased after high- than after low-speed walking.

4.3

HF, LF/HF, and HF/(LF + HF)

The mean HF,LF/HF, and HF/(LF + HF) values are shown in Fig. 5. Increases were seen in HF values for all conditions when comparing before and after the monotonous task. In addition, LF/HF values increased for all conditions, and HF/(LF + HF) values decreased after sitting in a chair and high-speed walking. Decreases were seen in HF values after sitting in a chair, whereas increases were seen after high-speed walking when comparing before and after exercise. Decreases were seen in LF/HF values after sitting in a chair and low-speed walking, but no changes were seen after high-speed walking. Increases were seen in HF/(LF + HF) values after low-speed walking, but no changes were seen after sitting in a chair or high-speed walking.

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Fig. 3. Results on the Roken Arousal Scale (RAS). (A) Mean values while sitting in a chair. (B) Mean changes after low-speed walking. (C) Mean changes after high-speed walking. † Indicates a marginal difference (p < 0.10). * Indicates a significant difference (p < 0.05). ** Indicates a strong significant difference (p < 0.01).

Effect of Walking upon Fatigue Due to Monotonous Work

Before

After the Monotonous work †

177

After the Active rest †

*

1 0.8 0.6 0.4

0.2 0 -0.2 -0.4 -0.6 Sitting in a chair

Low-speed walk

High-speed walk

Fig. 4. AAC values measured using EEG. The results were normalized for each participant. † Indicates a marginal difference (p < 0.10). * Indicates a significant difference (p < 0.05). ** Indicates a strong significant difference (p < 0.01).

5 Discussion In this study, we used body sensory vibration stimuli (UniMove) for monotonous work. As a result, increases on the RAS were seen in “Sleepiness”, “Difficulty maintaining attention and concentration”, and “Lack of motivation”, whereas decreases were seen in “Activation”. AAC values decreased and LF/HF values increased for all conditions. These findings suggest that the 30-min monotonous task caused stress in the participants. Differences were identified between walking and sitting when comparing before and after exercise. Decreases were seen in “Sleepiness”, “Difficulty maintaining attention and concentration”, and “Lack of motivation” on the RAS after walking. By contrast, no changes were seen in any of these states after sitting in a chair. Walking increased, whereas sitting decreased, AAC values. These findings suggest that walking counteracts the fatigue caused by monotonous work more effectively than sitting. In addition, when comparing before and after exercise, differences were identified between low- and high-speed walking. Increases were seen in “Activation” on the RAS after both low- and high-speed walking; the difference after high-speed walking was significant (p < 0.01). Decreases were seen in “Difficulty maintaining attention and concentration” after both low- and high-speed walking; the changes after high-speed walking were significant (p < 0.05). No changes were seen in HF values after low-speed walking, but increases were observed after high-speed walking; however, these changes were not statistically significant. Decreases were seen in the LF/HF ration after low-speed walking, but no changes were seen after high-speed walking. Significant increases were seen in HF/(LF + HF) after low-speed walking(p < 0.10), but no changes were observed after high-speed walking. These results suggest that low-speed walking is an effective relaxation method because it increases parasympathetic activity. These findings also suggest that high-speed walking is an effective

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A Before

After the Unimove

After the Active rest

†

0.6 0.4 0.2 0 -0.2 -0.4 -0.6 Sitting in a chair Low-speed walk High-speed walk

B Before

After the Unimove

After the Active rest **

†

2 1.5 1 0.5 0 -0.5 -1 -1.5 -2 Sitting in a chair

Low-speed walk

High-speed walk

C Before

After the Unimove †

After the Active rest †

†

1 0.8 0.6 0.4 0.2 0 Sitting in a chair Low-speed walk High-speed walk Fig. 5. LF and HF values measured by EEG. The results were normalized for each participant. (A) HF value. (B) LF/HF value. (C) HF/(LF + HF) value. † Indicates a marginal difference (p < 0.10). * Indicates a significant difference (p < 0.05). ** Indicates a significant difference (p < 0.01).

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method for clearing your consciousness because it increases alpha waves and sympathetic activity. Therefore, the fatigue caused by monotonous work can be counteracted by choosing an appropriate walking speed. Acknowledgements. This study was supported by the Ministry of Education, Culture, Sports, Science and Technology (MEXT)-Supported Program for the Strategic Research Foundation at Private Universities, 2013–2017.

References 1. Ministry of Health, Labour and Welfare, Comprehensive Survey of Living Conditions (2012) 2. Takahashi, M., Kitazima, H., Honjoh, Y.: Analysis of the relationship between sleepiness and relaxation using a newly developed mental work strain checklist. J. Sci. Labour 72(3), 89–100 (1996) 3. Hagiwara, H., Araki, K., Michimori, A., Saito, M.: A study on the quantitative evaluation method of human alertness and its application. Psychiatria et Neurologia Japonica 99(1), 23– 34 (1997) 4. Inamoto, T., Kanakura, T., Hagiwara, H.: Relationship between changes of alpha wave components and arousal level. Jpn. J. Ergon. Soc. 45, 478–479 (2009) 5. Watling, C.N., Smith, S.S., Horswill, M.S.: The effectiveness of nap and active rest breaks for reducing driver sleepiness. Soc. Psychophysiological Res. 51, 1131–1138 (2014)

Modeling Self-determination in Emotional Labor: Stressful Patient Interactions, Emotion Regulation, and Burnout in Geriatric Nursing Severin Hornung1,2(&), Bettina Lampert1, Matthias Weigl2, and Jürgen Glaser1 1

2

Institute of Psychology, University of Innsbruck, Innrain 52, 6020 Innsbruck, Austria {Severin.Hornung,Bettina.Lampert, Juergen.Glaser}@uibk.ac.at Institute for Occupational Medicine, University of Munich, Ziemssenstr. 1, Munich, Germany [email protected]

Abstract. Integrating theorizing on emotional labor performed by human service workers with assumptions of self-determination theory, this study tests a model of stressful patient interactions, psychological regulation of negative emotions, and symptoms of job burnout in healthcare professionals. Survey data of N = 1848 geriatric nurses in 111 nursing homes for the elderly in Germany were analyzed using latent-variable structural equation modeling. The specified phase model of interaction work and emotional regulation was well supported by the data. Emotion regulation mediated between stressful patient interactions and three dimensions of job burnout, namely emotional exhaustion, depersonalization, and reduced accomplishment. Differential correlational patterns confirmed faking in bad faith and deviant display as psychologically maladaptive, whereas faking in good faith and deep acting were found to be more functional. As hypothesized, factors connected to psychological need fulfillment according to self-determination theory positively influenced interactions, emotion regulation, and coping processes. Keywords: Emotional labor
Emotion regulation
Interaction work Self-determination
Patient aggression
Burnout
Geriatric nursing




1 Introduction The profession of geriatric nursing in Germany and elsewhere suffers from a problematic public image, tied to frequent news reports regarding deficiencies in the delivery of care [1–3]. At the same time, demographic change and increasing life expectancy lead to continuously increasing demand for geriatric nursing among a growing part of the population. These developments illustrate the need for a more systematic study of work processes in this field of health care [1]. Geriatric nursing is a prototypical kind of human service work, where the quality of service largely depends on interaction processes between service providers and care recipients [3, 4]. In the © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_19

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present study, we draw on concepts of emotional labor, burnout, and work-related psychological needs to develop a phase model of interaction work in geriatric nursing, which integrates stressful patient interactions, different modes of emotion regulation, and the etiology of work-related strain [5–7]. Based on self-determination theory [8], interaction control, interaction competence and, social support by supervisors and colleagues are examined as contextual factors. These are suggested to positively influence the trajectories of stressful patient interaction, emotion regulation, and burnout in human service work.

1.1

Emotional Labor and Self-regulation

Emotion regulation refers to the psychological processes through which individuals influence the experience as well the expression or display of emotions in interactions with others [9]. Interest in emotion regulation started with the pioneering research by Hochschild [10], who coined the term emotional labor to analyze, how employees control their emotional expression to fulfill their work role in accordance with organizational and professional display rules (e.g., treating clients or patients with positive regard, empathy, and compassion). Emotional labor applies the multi-dimensional concept of emotion regulation to work-related interactions [9, 11, 12]. Efforts of emotion regulation can be directed either at reducing discrepancies between expressed and required or between experienced and expressed emotions [13, 14]. The former is termed surface acting (influencing emotional display), while the latter involves deep acting (influencing experienced emotions) or may manifest in deviant behavior (violating display rules). Surface acting has been further differentiated into two distinct modes termed “faking in good faith” and “faking in bad faith” [4, 13]. Good faith acting is based on an internalized sense of professional responsibility and identification with one’s occupational role. Acting in bad faith is predominately externally motivated by concerns about negative repercussion, such as sanctions by the employing organization [1, 4]. Further, research has shown that fundamental differences exist regarding the psychological processes of regulating positive and negative emotions, as one requires displaying sentiments that are not genuinely felt (e.g., sympathy or joy), whereas the other emphasizes suppressing feelings, such as anger, dislike, and disgust [9, 13, 15]. The present study focuses on the regulation of negative emotions, distinguishing between the four modes of faking in good faith, faking in bad faith, deep acting and emotional deviance, main characteristics of which are summarized in Table 1.

1.2

Emotion Regulation and Job Burnout

As emotion regulation is psychologically effortful, previous research has focused on negative effects of emotional labor on worker health and job-related attitudes [12–14]. For instance, well established are relationships between emotional dissonance and job dissatisfaction, depression, and burnout. Especially burnout, defined as a syndrome of feeling emotionally drained and exhausted, cynical and depersonalized treatment of

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Regulatory focus Emotional display Reducing discrepancies between expressed and acceptable emotions Emotional dissonance Reducing discrepancies between experienced and expressed emotions

Weakly internalized Regulation modes Faking in bad faith Not showing felt negative emotions towards patients out of concern about professional repercussions Deviant display Venting negative emotions towards patients in violation of emotional display rules

Strongly internalized Regulation modes Faking in good faith Not showing felt negative emotions towards patients out of concern for one’s professional responsibility Deep acting Making conscious efforts not to experience negative emotions towards patients

care recipients, and reduced personal efficacy and sense of accomplishment, is a prototypical outcome of stressful interaction work and maladaptive emotion regulation processes [6, 16, 17]. However, cumulative research suggests that emotional labor does not necessarily need to have negative psychological consequences. Whereas surface acting, i.e., regulating emotional expression according to display rules, is often associated with psychological strain and impaired health, deep acting, i.e., conscious efforts to influence experienced emotions, has been shown to relate positively to well-being and job performance [7, 11]. Further, studies differentiating between the two modes of surface acting mentioned above, have found that the detrimental impact on worker health is mostly attributable to faking in bad faith, whereas faking in good faith can even stimulate positive psychological developments of resilience and growth [13–15]. Lastly, deviant emotional display indicates failed emotional regulation, which may trigger negative internal (e.g., guilt) and external consequences (e.g., reprimand), suggesting that emotional deviance may be associated with emotional depletion and burnout.

1.3

Psychological Need Fulfillment and Internalization

Modes of emotion regulation reflect different levels of psychological internalization of emotional display rules [7, 11]. While surface acting in good faith and deep acting are more autonomously regulated, acting in bad faith and deviant emotional display reflect externally controlled, respectively failed regulation. Based on self-determination theory, resources to support functional patient interactions and emotion regulation can be conceptualized as factors contributing to psychological internalization of role requirements via the fulfillment of work-related needs for autonomy, competence, and relatedness [8, 18]. In this study, factors relating to these three domains of psychological needs were represented by interaction control, interaction competence, and social support by supervisors and coworkers [1, 16]. Assumptions regarding the positive functions of these factors in different phases of the emotional labor process were integrated into the developed model, which will be outlined next.

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2 Hypotheses Drawing on previous conceptual and empirical work [7, 11], we developed a model of emotional labor that takes into account three distinct domains or phases of interaction work and its psychological consequences [1, 4, 16]. The three distinguished phases refer to (a) stressful patient interactions, (b) psychological processes of emotion regulation, and (c) strain responses in the form of emotional depletion and burnout. In the following, hypotheses underlying each of the three sections of the model will be recapitulated. A summary of all specified hypotheses is provided in Table 2. Table 2. Summary of model hypotheses. Phase I Hypothesis 1 Hypothesis 2 Hypothesis 3 Phase II Hypothesis 4 Hypothesis 5 Hypothesis 6 Hypothesis 7 Hypothesis 8 Phase III Hypothesis 9 Hypothesis 10 Hypothesis 11

Stressful patient interactions Patient aggression relates positively to negative emotions (H1) Interaction control and interaction competence relate negatively to patient aggression (H2a, H2b) and negative emotions (H2c, H2d) Quantitative and qualitative work overload relate positively to patient aggression (H3a, H3b) and negative emotions (H3c, H3d) Regulation of negative emotions Negative emotions relate positively to faking in good faith (H4a), faking in bad faith (H4b), deep acting (H4c), and deviant display (H4d) Display rule clarity relates positively to faking in good faith (H5a), faking in bad faith (H5b), and deep acting (H5c) and negatively to deviant display (H5d) Interaction control and interaction competence relate positively to faking in good faith (H6a, H6b) and deep acting (H6c, H6d) and negatively to faking in bad faith (H6e, H6f) and deviant display (H6g, H6h) Quantitative and qualitative work overload relate negatively to faking in good faith (H7a, H7b) and deep acting (H7c, H7d) and positively to faking in bad faith (H7e, H7f) and deviant display (H7g, H7h). Supervisor support and coworker support relate positively to faking in good faith (H8a, H8b) and deep acting (H8c, H8d) and negatively tofaking in bad faith (H8e, H8f) and deviant display (H8g, H8h) Emotional depletion and burnout Faking in good faith and deep acting relate negatively to emotional exhaustion (H9a, H9b), depersonalization (H9c, H9d), and reduced accomplishment (H9e, H9f) Faking in bad faith and deviant display relate positively to emotional exhaustion (H10a, H10b), depersonalization (H10c, H10d), and reduced accomplishment (H10e, H10f) Supervisor support and coworker support relate negatively to emotional exhaustion (H11a, H11b), depersonalization (H11c, H11d), and reduced accomplishment (H11e, H11f)

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Phase I: Stressful Patient Interactions

The first part of the developed model reflects emotionally stressful patient interactions, operationalized in terms of verbally and physically aggressive behavior of patients, triggering negative emotions in the affected caregivers (Hypothesis 1). The role of individual agency and behavioral alternatives was taken into account by including perceived interaction control and subjective interaction competence as factors that may reduce or help to prevent patient aggression and subsequent negative affective responses by the working individuals. (Hypothesis 2). Further, both the occurrence of patient aggression and negative emotions directed towards patients were assumed to be at least partly a function of overtaxing interaction conditions, manifesting in indicators of quantitative and qualitative work overload (Hypothesis 3).

2.2

Phase II: Regulation of Negative Emotions

The second part of the model focuses on processes of emotion regulation. At the center of this section is the taxonomy of emotion regulation modes introduced above. It was assumed that experienced negative emotions towards patients would trigger emotion regulation in the form of faking in good faith, faking in bad faith, deep acting, and deviant display (Hypothesis 4). Clarity of emotional display rules was assumed to be a central antecedent of emotional regulation, relating positively to faking in good faith, faking in bad faith, and deep acting, but negatively to deviant display (Hypothesis 5). As outlined above, acting in good faith and deep acting can be described as more strongly internalized and autonomously regulated modes, whereas acting in bad faith and deviant emotional display reflect externally controlled respectively failed regulation. Based on self-determination theory, psychological internalization and integration of role requirements is driven by the fulfillment of work-related needs for autonomy, competence, and relatedness. Accordingly, perceived interaction control and subjective interaction competence were expected to relate positively to functional regulation strategies of faking in good faith and deep acting and negatively to dysfunctional modes of faking in bad faith and deviant display (Hypothesis 6). Constraining autonomy and self-efficacy, opposite effects on emotion regulation were expected from quantitative and qualitative workload (Hypothesis 7). Further, social support by supervisors and coworkers was included as a potential factor in the internalization of functional, respectively the prevention of dysfunctional emotion regulation (Hypothesis 8), based on the fulfillment of psychological needs for relatedness.

2.3

Phase III: Emotional Depletion and Burnout

The third set of hypotheses refers to the consequences of functional and dysfunctional emotion regulation on psychological strain, operationalized in terms of job burnout as emotional exhaustion, depersonalization, and reduced accomplishment. Accordingly, it was assumed that the more functional modes of faking in good faith and deep acting relate negatively to emotional exhaustion, depersonalization, and reduced accomplishment (Hypothesis 9), whereas the rather maladaptive modes of faking in bad faith

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and deviant display would show the opposite pattern, relating positively to all three burnout dimensions (Hypothesis 10). Finally, the classic conjecture that psychological strain can partly be buffered or offset by supportive social workplace relationships, was represented by specifying negative direct effects of both supervisor and coworker support on burnout dimensions (Hypothesis 11).

3 Sample Data were gathered in a research project on working conditions and psychosocial worker health in geriatric nursing in Germany [1]. Initially, all 1,290 nursing homes located in the German Federal State of Bavaria were contacted. Out of those, 143 expressed their interest to participate in the study, however, 33 withdrew their agreement during the process, mostly citing organizational reasons (e.g., ongoing restructuring, management changes, understaffing). Eventually, 111 nursing homes participated, employing altogether 4957 geriatric nursing staff. Out of those, 1848 returned usable surveys, a 37.3% response rate. 86.4% of respondents were female; mean age was 40.3 years and average tenure 10.2 years. The majority of 62.5% had a professional degree in nursing; 38% worked part-time. Comparative analyses established that the sample was representative for geriatric nursing in Germany.

4 Measures Study constructs were measured with multi-item self-report survey instruments. In some instances, scales were developed and used in previous research by the authors [1, 4]. In other cases, established scales or abbreviated versions thereof were used [17]. Psychometric tests included internal consistencies (Cronbach’s alpha) as well as exploratory and confirmatory factor analyses (see below). A list of study constructs, measurement metrics, and descriptive statistics is provided in Table 3.

4.1

Patient Aggression

Patient aggression was measured with selected items from the Violence and Aggression in Health Care Questionnaire [5]. The stem of the measure reads: “In my work in this nursing home, it happens that patients…”; included were three items on verbally abusive behavior by patients (“swear at me”, “yell at me”, “insult me”) and three on experienced physical violence (“hit me”, “scratch me”, “kick me”). Respondents rated the frequency of such stressful incidents on a 6-point scale (1 = never; 2 = very seldom/every few years; 3 = seldom/every few month; 4 = sometimes/every few weeks; 5 = often/every few days; 6 = very often/on a daily basis).

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S. Hornung et al. Table 3. Study constructs, measurement, and descriptive statistics. Construct Patient aggression (verbal) Patient aggression (physical) Negative emotions Faking in good faith Faking in bad faith Deep acting Deviant display Display rule clarity Interaction control Interaction competence Quantitative workload Qualitative workload Supervisor support Coworker support Emotional exhaustion Depersonalization Reduced accomplishment

4.2

Label PAGv PAGp NEG FGF FBF DAC DEV DRC ICN ICM QNW QLW SUS COS EEX DEP RAC

Items 3 3 4 4 4 4 4 2 3 3 3 3 3 3 3 3 3

Alpha .85 .86 .74 .88 .94 .93 .88 .82 .85 .81 .86 .94 .93 .89 .88 .70 .75

Range 1–6 1–6 1–6 1–5 1–5 1–5 1–5 1–5 1–5 1–5 1–5 1–5 1–5 1–5 1–6 1–6 1–6

Mean 3.05 2.47 2.46 3.87 2.10 3.68 1.62 3.27 4.15 3.91 3.21 2.93 3.34 3.75 3.27 1.59 2.09

SD 1.22 1.08 0.88 0.97 1.04 1.10 0.65 1.10 0.68 0.59 1.00 1.03 1.12 0.86 1.34 0.79 0.71

Negative Emotions

Respondents were asked to rate the frequency with which they felt negative emotions towards patients (“How often do you feel the following emotions towards patients in your work?”) on a 6-point scale (1 = never; 2 = very seldom/every few months; 3 = seldom/every few weeks; 4 = sometimes/every few days; 5 = often/every day; 6 = very often/several times a day). The scale was based on four items, representing the following negative emotions: (a) aversion, (b) disgust, (c) anger, and (d) fear.

4.3

Emotion Regulation Modes

Drawing on previously developed measures [1, 4], four modes of regulating negative emotions were included: (a) faking in good faith (“I do not show felt [emotion] towards patients, because I take my professional responsibility seriously”); (b) faking in bad faith (“I do not show felt [emotion] towards patients, because I would expect professional problems otherwise”); (c) deep acting (“I make honest efforts not to feel [emotion] towards patients”); and (d) deviant display (“I display [emotion] towards patients, even though I know I am not supposed to”). Scales comprised four items each, referring to the same negative emotions as above (aversion, disgust, anger, fear). Response format was a 5-point Likert-scale (1 = not at all, 2 = rather not, 3 = somewhat, 4 = to a great extent, 5 = to a very great extent).

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Display Rule Clarity

The extent to which clarity existed regarding appropriate display of emotions towards patients was measured with two items [4], one referring to the organization, the other to the occupational level (“In this organization/the geriatric nursing profession there are clear expectations as to which situations warrant what type of emotional display toward patients”). Items were answered on the 5-point Likert-scale as reported above.

4.5

Interaction Control and Competence

A 3-item scale of interaction control assessed the extent to which nurses felt they possessed the agency to decide for themselves if, when, and how to respond to the emotions of their patients (e.g., “I can determine for myself how I respond to patients’ emotions”). Self-efficacy beliefs regarding interaction work were measured with another three items, referring to perceived competencies in recognizing, understanding, and positively influencing the emotions of patients (e.g., “I am particularly good at understanding the emotions of patients”). Both scales used the above 5-point format.

4.6

Quantitative and Qualitative Overload

Quantitative and qualitative work overload were measured with two 3-item scales from an established work analysis instrument for healthcare settings, employing the above 5-point scale [1, 16]. Items on quantitative overload operationalized an overtaxing amount of job duties, workload exceeding the time available for its accomplishment, and conflicts between quantity and quality goals (e.g., “The workload is often so high that the quality of work suffers”). Qualitative overload was assessed with another 3 items, referring to overtaxing work demands due to difficult patient attributes, such as dementia, deteriorating mental health, and psychological disorders (e.g., “This work is often stressful due to patients with deteriorating mental health”).

4.7

Supervisor and Coworker Support

Based on an established measure [19, 20], respondents rated the extent to which supervisors and coworkers provided emotional (“listening understandingly”), informational (“giving helpful advice”), and instrumental (“helping me to get the job done”) support, using a 5-point Likert-scale (1 = not at all; 5 = to a very great extent). Both scales contained three items, worded similarly for supervisors and coworkers.

4.8

Job Burnout

Job Burnout was assessed with an abridged German version of the Maslach Burnout Inventory [16, 17]. The three established dimensions of burnout – emotional exhaustion, depersonalization, and reduced accomplishment– were measured with 3 items each, rated on a 6-point frequency scale (1 = never; 6 = very often). Items tapping

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personal accomplishment were recoded, such that for all three dimensions, higher values indicate more severe symptoms of job burnout.

5 Analyses Following a two-step approach to the analysis of covariance structures, measurement models were established through Confirmatory Factor Analysis (CFA) and subsequently integrated into a latent-variable Structural Equation Model (SEM). Analyses were conducted with the software AMOS 23.0 [21]. Model fit was evaluated based on established fit indices and cut-offs [22, 23]. Significance of the chi-square statistic (v2) was not considered sufficient for model rejection, yet lower values are desirable. Incremental Fit Index (IFI), Comparative Fit Index (CFI), and Tucker Lewis Index (TLI) should be at least .90. The Root Mean Square Error of Approximation (RMSEA) should ideally remain below .05 while values of up to .08 are considered acceptable. Hoelter’s Critical N (CN) is the theoretical sample size for which the chi-square discrepancy would be non-significant and should be at least 200.

6 Results Measurement models were tested in several steps. Goodness-of-fit indices are displayed in Table 4. First a 2-factor model of verbal and physical patient aggression was established (CFA 1). Second, a 5-factor model confirmed the distinctness of experienced negative emotions and regulation modes (CFA 2). Third, a 3-factor model of burnout was tested (CFA 3). Finally, a 7-factor model indicated a suitable factor structure of the remaining constructs. Based on these results, the structural model was specified [21]. Patient aggression was modeled as a latent variable based on two manifest indicator (scale) parcels for verbal and physical aggression. Negative emotions, emotion regulation modes, and burnout were included as eight item-level latent variables. To reduce model complexity, the seven independent constructs were modeled as intercorrelated manifest variables [23]. Directed structural paths were added, reflecting hypotheses 1–11. While model fit was acceptable (SEM 1), it could be improved substantially by adding two non-hypothesized paths from interaction competence on reduced accomplishment and from quantitative workload on emotional exhaustion (SEM 2). Parameter estimates for this final model are provided in Table 5. Table 4. Goodness-of-fit indices. v

2

df

CFA 1 47.43 8 CFA 2 870.30 160 CFA 3 141.24 24 CFA 4 702.81 149 SEM 1 3090.21 592 SEM 2 2494.92 590

v2/df 5.93 5.44 5.89 4.72 5.22 4.23

IFI .99 .97 .98 .98 .92 .94

TLI .98 .96 .96 .97 .91 .93

CFI .99 .97 .98 .98 .92 .94

CN 604 405 477 470 389 480

RMSEA .052 [.038–.066] .049 [.046–.052] .051 [.043–.060] .045 [.042–.048] .048 [.046–.049] .042 [.040–.044]

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Table 5. Standardized path coefficients in the final structural model. PAG

PAG NEG – .41** (H1) – –

FGF –

−.01 (H4a) DRC – – .11** (H5a) ICN .01 −.04 .02 (H2a) (H2c) (H6a) ICM −.02 −.11** .12** (H2b) (H2d) (H6b) QNW .24** .10** .06 (H3a) (H3c) (H7a) QLW .19** .21** .00 (H3b) (H3d) (H7b) SUS – – −.01 (H8a) COS – – .03 (H8b) FGF – – – NEG

FBF –

DAC DEV – –

EEX –

DEP –

RAC –

.24** (H4b) .09** (H5b) −.14** (H6e) −.02 (H6f) .08** (H7e) −.08** (H7f) −.10** (H8e) .04 (H8f) –

.01 (H4c) .11** (H5c) .02 (H6c) −.02 (H6d) .07* (H7c) −.03 (H7d) .02 (H8c) .02 (H8d) –

.30** (H4d) .01 (H5d) −.08** (H6g) −.20** (H6h) .04 (H7g) .06* (H7h) −.04 (H8g) −.00 (H8h) –

–

–

–

–

–

–

–

–

–

–

–

−.46** (extra) –

–

–

–

–

–

–

DAC –

–

–

–

–

–

–

–

–

–

–

–

FBF

DEV

.42** – (extra) – – −.12** (H11a) −.10** (H11b) .05* (H9a) .11** (H10a) −.01 (H9b) .09** (H10b)

−.09** (H11c) −.11** (H11d) −.12** (H9c) .21** (H10c) .02 (H9d) .41** (H10d)

– −.17** (H11e) −.10** (H11f) −.05 (H9e) .06* (H10e) −.01 (H9f) .15** (H10f)

Note. N = 1848;**p < .01, *p < .05.

6.1

Phase I: Stressful Patient Interactions

Hypothesis 1 was supported, as the frequency of exposure to patient aggression correlated positively with experienced negative emotions towards patients (H1). Hypothesis 2 received only weak support; out of the four hypothesized negative effects of interaction control and interaction competence on patient aggression and experienced negative emotions toward patients, only a negative relationship between interaction competence and negative emotions was confirmed (H2d). In contrast, Hypothesis 3 was fully supported, as both quantitative and qualitative work overload explained significant variance in both patient aggression and negative emotions, thus confirming the important role of workload in the occurrence of stressful patient interactions.

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Phase II: Regulation of Negative Emotions

Hypothesis 4 was partially supported, as negative emotions towards patients related positively to faking in bad faith and deviant display, but not to faking in good faith or deep acting. A large degree of support was obtained for Hypothesis 5, confirming emotional display rule clarity as an important factor in stimulating emotion regulation of faking in good faith, faking in bad faith, and deep acting, while showing no association with deviant display. With regard to Hypothesis 6, results were mixed, yet, overall, supported the relevance of interaction control and competence for functional emotion regulation. Specifically, interaction control related negatively to faking in bad faith and deviant display, whereas interaction competence showed a positive association with faking in good faith and a negative effect on deviant display. Also, only partially corresponding to expectations was the role of work overload, postulated in Hypothesis 7. Whereas quantitative overload related positively to faking in bad faith and deep acting, qualitative workload related negatively to faking in bad faith and positively to deviant emotional display. Limited support was obtained for Hypothesis 8. With the exception of a negative association between supervisor support and faking in bad faith, no indication was found that social support exerts an important role in influencing how geriatric nurses regulate negative emotions towards patients.

6.3

Phase III: Emotional Depletion and Burnout

Hypothesis 9 specified negative relationships between functional emotion regulation strategies and burnout dimensions. However, empirical support for such a health-supportive function was largely absent. While faking in good faith related positively to emotional exhaustion and negatively to depersonalization, deep acting was unrelated to all three burnout components. In contrast, a very clear pattern was found with regard to the negative or health-impairing effects of dysfunctional emotion regulation approaches. Confirming Hypothesis 10, faking in bad faith and deviant display each related positively to all three dimensions of job burnout. Finally, Hypothesis 11 was also fully supported; both supervisor and coworker support related negatively to emotional exhaustion, depersonalization, and reduced accomplishment, thus demonstrating the key role of social resources in the burnout process.

7 Discussion A phase model of the emotional labor process was tested, integrating stressful patient interactions, different modes of emotion regulation, and burnout [1, 16]. Emotionally stressful work interactions were operationalized through the frequency of exposure to verbal and physical patient aggression and experienced negative emotions towards patients, specifically, aversion, disgust, anger, and fear [4]. Emotion regulation strategies were shown to mediate between negative emotions towards patients and the three dimensions of job burnout. Faking in bad faith and deviant display were associated with emotional exhaustion, depersonalization, and reduced accomplishment. In contrast, faking in good faith showed a weaker relationship with exhaustion and related

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negatively to depersonalization. No significant relationship between deep acting and burnout were found. Overall, results therefore confirmed faking in bad faith and deviant display as maladaptive, whereas faking in good faith and deep acting appear to be more functional strategies to cope with emotionally distressing patient interactions [7, 11]. With the exception of deviant emotional display, clarity of emotional display rules strengthened emotion regulation attempts. Results regarding the role of workload were not fully conclusive, but suggest that quantitative overload poses a more severe threat to successful emotional labor than qualitative patient demands [1]. Contextual factors connected to work-related psychological needs for the experience of autonomy, competence, and relatedness positively influenced interpersonal interactions, emotion regulation processes, and mental health of the nursing professionals [8, 18]. Interaction control seems to inoculate workers against dysfunctional emotion regulation in the form of faking in bad faith and deviant display. Feeling well prepared and competent to deal with patients’ emotions appeared to prevent displays of negative emotions. Whereas supportive supervision contributed to preventing dysfunctional emotional regulation through faking in bad faith, the predominant role of social support appeared to be a buffering or compensating effect on symptoms of mental health impairment [19]. In sum, favorable conditions for experience of autonomy, competence, and relatedness in the care process tended to, in varying degrees, prevent breakdowns in patient interactions, facilitate functional emotional regulation, and contribute to employee resilience. These differential finding scan be used to design and implement interventions to improve the socio-technical design of healthcare organizations by creating working conditions and training programs that support functional patient interactions and adaptive emotional regulation, thus promoting quality of care and mental health of human service providers. Due to the context of this study, results have particular relevance and applicability to geriatric nursing [3]. Focusing on the work-related experience, regulation modes, and consequences of negative emotions, our study illuminates the “dark side” of emotional labor, but neglects triggers, displays, and effects of positive emotions [15]. A methodological limitation is reliance on cross-sectional single-source data, such that results entirely reflect the subjective experience of the working individuals and inferences on temporal trajectories are tentative at best. Assets are the defined representative sample and methodologically robust empirical testing of an integrative theory-based model. Providing a well-developed psychological framework, self-determination theory was shown useful to enrich and extend research on the emotional labor process, generating relevant implications for work and organizational design in healthcare settings.

References 1. Glaser, J., Lampert, B., Weigl, M.: Interaction, work load, health, and work design in nursing for the elderly. In: Richter, P. (ed.) Psychosocial Resources in Human Service Work, pp. 13–26. Hampp, München (2007) 2. Elovainio, M., Sinervo, T.: Psychosocial stressors at work, psychological stress and musculosceletal symptoms in the care for the elderly. Work Stress 11, 351–361 (1997)

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3. Castle, N.G., Engberg, J.: Staff turnover and quality of care in nursing homes. Med. Care 43, 616–626 (2005) 4. Büssing, A., Glaser, J.: Interaction work: concept, measurement, and results from nursing. In: de Jonge, J., Vlerick, P., Büssing, A., Schaufeli, W.B. (eds.) Organizational Psychology and Health Care at the Start of a New Millennium, pp. 175–196. Hampp, München (2001) 5. Büssing, A., Höge, T.: Aggression and violence against home care workers. J. Occup. Health Psychol. 9, 206–219 (2004) 6. Ben-Zur, H., Yagil, D.: The relationship between empowerment, aggressive behaviours of customers, coping, and burnout. Eur. J. Work Organ. Psychol. 14, 81–99 (2005) 7. Hülsheger, U.R., Schewe, A.F.: On the costs and benefits of emotional labor: a meta-analysis of three decades of research. J. Occup. Health Psychol. 16, 361–389 (2011) 8. Gagné, M., Deci, E.L.: Self-determination theory and work motivation. J. Organ. Behav. 26, 331–362 (2005) 9. Gross, J.J.: The emerging field of emotion regulation: an integrative review. Rev. Gen. Psychol. 2, 271–299 (1998) 10. Hochschild, A.R.: The Managed Heart: Commercialization of Human Feeling. University of California Press, Berkeley (1983) 11. Grandey, A.A., Diefendorff, J.M., Rupp, D.E.: Emotional Labor in the 21st Century: Diverse Perspectives on Emotion Regulation at Work. Routledge, New York (2013) 12. Grandey, A.A.: Emotion regulation in the workplace: a new way to conceptualize emotional labor. J. Occup. Health Psychol. 5, 95–110 (2000) 13. Rafaeli, A., Sutton, R.I.: Expression of emotion as part of the work role. Acad. Manage. Rev. 12, 23–37 (1987) 14. Morris, J.A., Feldman, D.C.: The dimensions, antecedents, and consequences of emotional labor. Acad. Manage. Rev. 21, 986–1010 (1996) 15. Glomb, T.M., Tews, M.J.: Emotional labor: a conceptualization and scale development. J. Voc. Behav. 64, 1–23 (2004) 16. Büssing, A., Glaser, J.: The four-stage process model of core factors of burnout: the role of work stressors and work-related resources. Work Stress 14, 329–346 (2000) 17. Maslach, C., Jackson, S.E., Leiter, M.P.: Maslach Burnout Inventory Manual, 3rd edn. Consulting Psychologists Press, Palo Alto, CA (1996) 18. Ryan, R.M., Deci, E.L.: Self-determination theory and the facilitation of intrinsic motivation, social development, and well-being. Am. Psychol. 55, 68–78 (2000) 19. Dormann, C., Zapf, D.: Social support, social stressors at work, and depressive symptoms: testing for main and moderating effects with structural equations in a three-wave longitudinal study. J. Appl. Psychol. 84, 874–884 (1999) 20. Frese, M.: Social support as a moderator of the relationship between work stressors and psychological dysfunctioning: a longitudinal study with objective measures. J. Occup. Health Psychol. 4, 179–192 (1999) 21. Byrne, B.M.: Structural Equation Modeling with Amos: Basic Concepts, Applications, and Programming. Erlbaum, Mahwah (2001) 22. Brown, T.A.: Confirmatory Factor Analysis for Applied Research. Guilford Press, New York (2006) 23. Kline, R.B.: Principles and Practice of Structural Equation Modeling, 3rd edn. Guilford, New York (2011)

Assessment of Postural Analysis in a Dialysis Clinic Kira Andrea C. Chan(&), John A. Molina, and Denise Ann T. Tirthdas Melchor Hall, University of the Philippines Diliman, Quezon City, Philippines [email protected], [email protected], [email protected]

Abstract. Nursing is one of the most hazardous occupations. The study aims to investigate the discomfort perceived by the nurses in a dialysis clinic, assess the clinic workspace and its effect on the nurse’s posture, and establish the factors associated to the perceived discomfort. The Standardized Nordic Questionnaire, Rapid Entire Body Assessment, Spearman Correlation, and related literature were used to determine the physical risk factors present. It was found that 73.33% of the nurses at the clinic experience pain in their lower back and all 5 nurses on the observed shift were at the medium risk level. Recommendations include increasing workstation table height by 10–15 cm to provide adequate knee space for the nurses, and increasing the height of the patient’s chair armrest by at least 10 cm, and the height of the patient’s chair from 53 cm to at least 65–72 cm. Keywords: Human factors


Healthcare
Work environment

1 Background of the Study and Rationale Nurses are the patient’s primary healthcare provider. They perform a variety of tasks such as “assess[ing] patient health problems and needs, develop[ing] and implement [ing] nursing care plans, and maintain[ing] medical records” [1]. Renal nurses specialize in providing renal care at hospitals, dialysis clinics, and other medical institutions. At present, there are 23, 232 members of the Renal Nurses Association of the Philippines [2]. Philhealth has also accredited 209 kidney dialysis clinics nationwide [3]. Our study aims to investigate the discomfort perceived by renal nurses in a dialysis clinic, assess the clinic workspace and its effect on the nurse’s posture, and establish the factors associated to the perceived discomfort. No studies have linked the effect of the physical elements of the clinical environment to the nurse’s posture in the Philippine setting, despite 1/3 of Filipino nurses reported work-related injuries and 1/3 of nurses have also missed 2 or more days of work due to these injuries. Furthermore, 78% had experienced back pain due to work [4].

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2 Problem Statement Nursing is a high-risk occupation, which is partially caused by the clinic work environment. Right now, there are a lack of studies and data with regards to the workspace and the frequency of work-related body pain.

3 Review of Related Literature 3.1

Clinical Environment

Effect of the Clinic Workspace on Nurses’ Posture. The categories of physical risk factors listed by Sherehiy et al. [5] are physical load, work posture, work task and activities, ergonomics of the ward, and physical condition of the work environment. Most studies however, have focused on “education and training in back care, body mechanics, and lifting techniques.” Nelson also focused on patient handling in her study [6]. However, Nelson states that “the clinical setting needs to be evaluated for safety as well, as the environment may be contributing to risk.” The workspace factors recommended for evaluation were space constraints, floor surface, lighting, height of work surfaces, adequacy of storage areas, temperature, ventilation, humidity, and selection and design of furniture. The factors to be included in the study are height of work surfaces, adequacy of storage areas, and selection and design of furniture since the study centers on the physical elements present in the clinic. The article ‘Risk Factors for Musculoskeletal Disorders in the Nursing Profession’ also indicated that “…clinical area [is an] important risk factor for MSD.” The selected studies, however, focused on the varying risks between hospital and home care environments, rather than different specializations [5]. Studies have shown that designing the workspace in laboratories and hospital settings have proven to be effective in decreasing musculoskeletal pain on nurses [5]. No studies were centered on the dialysis clinic environment. The following research shows the ergonomic standards for our chosen workspace factors in other medical environments. Ideal Height of Work Surfaces. The best height for work surfaces is between the pelvic area and the shoulders of the nurse. Frequent bending and twisting will result into back pain and other pressure-related injuries. The operating bed should be adjustable so that the nurse and doctor will be operating comfortably, with the height being elbow level ideally. Bed-making, injections, feeding, and patient transfer all put stress on the back of the nurse. Adjustable beds remedy this problem. A lot of load is being put on the back the back of a nurse when pushing a patient on a wheelchair. To minimize the stress being placed on the back, the wheelchair should be adjustable so that the nurse is not bending while pushing the patient. Also, a motorized wheelchair will reduce the stress on the back significantly. Documents and tools that are frequently accessed should be placed at elbow level. Computer monitors should be placed at eye level, while the keyboard and mouse should be placed at elbow to prevent excess strain in the wrists and back.

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Adequacy of Storage Areas. Storage should be sufficient to store documents, equipment, clothes and should be located systematically throughout the workspace. There should be a storage room for rarely used equipment and tools. In some clinics, most equipment is left at the sides of the corridor, which pose as a danger to people travelling across the corridor. Frequently accessed documents should be stored within reach of the workstation of the nurse, and should be easily accessible by everyone. Light objects and documents can be stored in high shelves, while heavy objects and equipment should be stored near the elbow height level. Documents and tools that are frequently accessed should be placed at elbow level. Computer monitors should be placed at eye level, while the keyboard and mouse should be placed at elbow to prevent excess strain in the wrists and back. Ideal Furniture Design. Chairs should be easily adjustable and reclined so that the ideal posture can be performed regardless of the height and body type of the nurse sitting. The lower portion of the legs should vertical while the thighs should be horizontal. The seat width should be between 17–20 inches, and the front edge of the seat should be round and padded. Also, the seat should be able to swivel easily. The backrest should be between 12 and 19 inches wide and offer solid back support, while maintaining adjustability. The seat material should be comfortable, but not too soft. Armrests should not impede the user and is optional. Patient beds should be easily adjustable as well. Most of the back stress experienced by nurses is caused by transferring the patient from the bed, making the bed, and repositioning the patient. The height should be adjustable so that the nurse will bend minimally. Wrist pads can be added to the workstation if the user is continuously typing and is experiencing strain in the wrists. There should also be enough knee room in order to accommodate changes in the sitting position of the user. Footrests also help the user to keep their foot flat when in a different sitting position. Desk lamps should also be present to provide ample light [7, 8]. 3.2

Tools to Be Used in the Study

Standardized Nordic Questionnaire. The Standardized Nordic Questionnaire is a multiple-choice questionnaire used to assess bodily pains, specifically musculoskeletal disorder pains, in the back, neck, shoulders and other locomotive organs. It was developed for the fields of ergonomics and occupational health care service. In 1987, it had already been used in 100+ different projects in Denmark, Finland, Norway, and Sweden. It was also used by Yasobant and Rajkumar to localize the pain risk in the different body regions for nurses in India [9]. Reliability studies have also been conducted on the Standardized Nordic Questionnaire. Kuorinka also reported that a reliability study of the Standardized Nordic Questionnaire (lower back) was conducted on nurses. The study administered the Standardized Nordic Questionnaire (lower back) twice with a 15-day period between testing. Dissimilar answers ranged only from 0–4%. Another study by Descatha et al. also concluded that the Nordic Questionnaires were valid for the upper-limb work related musculoskeletal disorders [10].

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Spearman Correlation. Correlations are used to quantify the presumed relationships of two variables and the strength of that relationship. It is also used to study the characteristics of this relationship. A correlation coefficient focuses on how two variables vary in relationship to each other. The Spearman coefficient measures the rank order of the data points. It also measures the strength and direction of association between two ranked variables. It assumes that the two variables are either ordinal, interval or ratio. The Spearman coefficient focuses more on the monotonic relationship while the Pearson correlation focuses on the linear relationship between the two variables. Methods of Postural Assessment. The Rapid Entire Body Assessment (REBA) is an ergonomic assessment tool that evaluates the ergonomic risk of a particular task or job to the both the to the both upper and lower parts of the musculoskeletal system. (Li and Buckle 1999). REBA was developed and designed particularly to assess the working postures, and the musculoskeletal risks associated with certain task in the healthcare sector, and other service industries. This postural analysis tool uses a scoring system for muscle activity (Hignett and McAtamney 2000). It takes into account several factors such as required or selected body posture, exerted force, type of movement, repetitiveness of the movement, and coupling. In a study conducted by Motamedzade et al. on ergonomic risk assessment in an engine company, REBA and Quick Exposure Check were utilized to identify risky jobs, and determining the potential risk for incidence of work-related musculoskeletal disorders [11, 12].

4 Methodology The study aims to examine the height, adequacy, and design of the workspace, storage areas, and other furniture present in the dialysis clinic. The pain risk as a result of the nurse’s interaction with these environmental factors in the dialysis clinic will then be quantified. 1. An initial assessment of the workspace was conducted based on prior research on the ideal workspace. The group photographed the clinic interiors, and took the measurements of all tables, chairs, equipment etc. present in the clinic. The clinic measurements were compared against the ideal ergonomic standards. The group focused on the following factors: height of work surfaces, adequacy of storage areas, and selection and design of furniture. 2. 15 nurses were interviewed to gather input on the nurse’s perception on how their work routine and workspace affect their physical health. The Standardized Nordic Questionnaire was used as a basis for the interview, since it is widely used and reliable. Other information was also gathered about the nurse’s work history, age, height, and lifestyle factors. 3. The following information and methods was gathered from all nurses working in a particular 8-h shift: anthropometric measurements, photos of the nurses for work sampling and Rapid Entire Body Assessment (REBA), taken twice every hour.

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The REBA was used over other body assessment methods since it is easy to use, inexpensive, and considers the important factors needed for the study. 4. The Spearman Correlation was computed to determine if other factors could have an effect on the nurse’s body pain. The Spearman Correlation was used since the variables are not normally distributed.

5 Results and Discussion All 15 nurses in the dialysis clinic were interviewed. There are no gaps greater than 20% for the gender and length of employment demographics. A majority of the nurses (53.33%) are aged between 26–30. While the height of the nurses slightly skews towards the shorter side since 53.33% of the nurses are below 5”3, there is no 3” height range that dominates the others. Body Pain Frequency. All nurses were then interviewed using the Standardized Nordic Questionnaire as a basis for the interview. Other lifestyle factors and opinions were also asked during the interview. It was found that 80% of the nurses experienced body pain at least once a week, and 46.67% of nurses experience body pain after every shift (Tables 1 and 2).

Table 1. Body pain frequency of nurses Frequency # of nurses Every shift 7 3–4  a week 1 1–2  a week 4 1–2  a month 2 1–2  a year 0 Never 1 Total 15

Table 2. Frequency of pain in specific body areas in nurses Body part Neck Shoulder Upper back Lower back Middle back Wrist Finger pad Knee Calf Feet

Every day 3–4 A week 1-A week 1–2 A month 1–2 A year Total 2 0 1 2 1 6 1 0 0 2 0 3 2 1 1 1 0 5 4 2 4 1 0 11 1 0 0 0 0 1 0 0 0 0 1 1 0 0 0 1 0 1 0 0 1 0 0 1 2 0 0 0 0 2 0 0 0 1 0 1

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Overall, the lower back is the most discomforting body area for the nurses, with 73.33% of nurses experiencing pain in their lower back. Among the nurses who experience lower back pain, 90.09% of the nurses would feel it at least once a week. The upper body was found to be the most significant body region; the top 4 areas (lower back, neck, upper back, shoulder) for body pain in nurses are all located in the upper body. Correlation. To determine whether other factors could have affected the body pain felt by the nurses, the Spearman Rank Correlation coefficient was used. The spearman coefficient between the height of the nurses and the frequency of pain that they experienced per week is 0.921 while the spearman coefficient between the stay of the nurses in months and the frequency of pain per week is 0.519. This shows that there is a high correlation of the height of nurses and the frequency of pain that they experience, and that there is a significant correlation between how long the nurses have been working and the frequency of pain. Based on this, the clinic work area was observed while the nurses were at work to see the factors that would affect the nurses with the pain that they were experiencing. Sample Shift Data. An assessment of each work area was conducted over an 8-h shift period. Five nurses were on shift. Their anthropometric measurements were measured by the group (Table 3).

Table 3. Anthropometric measurement of nurses on shift C Shoulders to elbow 21.5 Elbow to wrist 23 Wrist to middle finger 16 Foot to shoulders 121 Foot to elbow 95 Foot to wrist 74 Foot to hips 87 Foot to knee 45 Height 148.5

D 25 26 20 142 113 89 101 51 170

L 27 22.6 18 128 100 77 91 46 160

A 28 24 20 143 112 88 98 52 175

M 23 23 18 132 103 81 93 49 160

The anthropometric measurements of each nurse on shift are presented in the table above. C is the shortest female nurse in the clinic, D is the tallest female nurse. L and M are of average height for female nurses. A is the sole male nurse in the shift and his height is average among the males. Clinic Work Areas. Selected work areas in the dialysis clinic were assessed to check compliance against researched ergonomic standard workplace guidelines. Work sampling was also conducted to evaluate the nurse’s work postures using REBA. The work areas selected were the Staff Pantry, Records, Nurse Workstation, Service Hallway, and Treatment Area. These areas were selected since the nurses frequented these areas during their daily routine, based on the work sampling. The results of the

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work sampling can be seen below. Across all areas, the nurses spend around 75% of their shift in various standing positions (Table 4). Table 4. Work sampling results Area Pantry Nurse’s workstation Patient area Medical records General hallway Total

# of postures taken Average time spent in area (%) 7 8.31 24 28.60 48 57.13 3 3.53 2 2.43 84 100.00

REBA Results. The average REBA score for each nurse falls in the medium risk level, which is an indicator of necessary change in the workspace (Fig. 1).

Fig. 1. REBA score table

D had the highest maximum REBA score, which will be seen later in the paper. M had the lowest maximum REBA score. A and C had the highest average REBA score, and all have the same minimum REBA score of 3. It’s important to note that A is 175 cm tall, D is 170 cm tall, M is 160 cm tall, and C is 148.5 cm tall (Table 5). Table 5. REBA scores per nurse for the full 8 h shift (rounded to two decimal places) C D Average 5.24 4.94 Maximum 9 10 Minimum 3 3

L 4.94 7 3

A 5.24 8 3

M 4.19 6 3

Another indicator for necessary change is the average REBA score per work area, which also falls in the medium risk level. An analysis for each work area is presented below. Each analysis includes the area’s REBA score, the posture that attained the maximum REBA score, and further discussion of some of the physical elements in the workspace (Table 6). Table 6. REBA scores per work area (rounded to the two decimal places) # of occurrences Ave Min Max

H 2 5 3 7

MR NW 3 20 7 4.71 6 3 9 8

P TA 7 46 4.43 4.96 3 3 6 10

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Staff Pantry. The staff pantry is where the nurses eat during their lunch break. They spend approximately 8.31% of their work shift in the pantry. The average REBA score for the pantry falls in the medium risk level range, implying that change is necessary and should be implemented. The max REBA score is obtained by A, and he was fixing his backpack, as shown below. He is slouching and his neck is severely bent forward (Fig. 2).

Fig. 2. C accessing documents

The hard chair was found to be compact and stackable, however it is a bit too low not padded, and does not provide adequate back support (Table 7).

Table 7. REBA scores in the pantry area (rounded to 2 decimal places) Number of occurrences 7 Average 4.43 Minimum 3 Maximum 6

Records. The medical records room is where the patient’s medical history is stored. The nurses spend approximately 3.53% of their time in the medical records room. It was observed that frequently accessed items are located at the lower shelf, and nurses are often bending to retrieve documents (Fig. 3).

Fig. 3. C accessing documents

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This is reflected in the average REBA score. While it falls in the medium risk level, it was highest among all the work areas. The max REBA score is 9, and it was C who obtained that score. Her posture is shown in the picture below. Although she is the smallest nurse in the clinic, she is bending severely, twisting her neck, and both of her arms are in awkward positions. It’s important to note however that there were only 3 occurrences in the medical records, meaning that more occurrences should be recorded before drawing further conclusions (Table 8). Table 8. REBA scores in the medical records area Number of occurrences 3 Average 7 Minimum 6 Maximum 9

Nurse Workstation. The nurse workstation is located in the center of the treatment room. The nurses spend 28.60% of their shift in the nurse’s workstation. Activities done in the nurse workstation are charting (45.83%), talking to other nurses (33.33%), and other miscellaneous activities such as opening drawers, answering the phone, and computer work (20.83%) (Fig. 4).

Fig. 4. A charting

The average REBA score for the Nurse Workstation falls in the medium risk level, implying that change is necessary and should be implemented. The max REBA score is 8, and it was A who obtained that score. He is the tallest of the 5 nurses examined and he was standing while charting, causing him to bend almost perpendicular to the ground. The desk was found to be too short and did not provide adequate legroom. The full height of the desk is 70 cm. The height from the floor to the underside of the desk is 53 cm. The foot to knee length of the nurses range from 46–52 cm, which leaves at most 7-cm knee space and 1 cm at the least. It was observed that the nurse’s knees Table 9. REBA Scores in the nurse workstation area (rounded to 2 decimal places) Number of occurrences 24 Average 4.71 Minimum 3 Maximum 8

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would hit the desk frequently. Though chairs are provided in the nurse’s workstation, the chairs are not adjustable, and occasionally the nurse may only need to stay at the workstation for a few minutes, making sitting unnecessary (Table 9). Service Hallway. The service hallway connects the treatment room to the other rooms in the clinic such as the waste room, storage room, and reprocessing room. The nurses leave used dialyzers in the service hallway for cleaning in the reprocessing room. Only 2.43% of the shift is spent in the service hallway. The average REBA score for the hallway is 5, which falls in the medium risk level, meaning that change should be implemented. However, there were only 2 occurrences in the hallway. More occurrences should be recorded before drawing a conclusion (Fig. 5).

Fig. 5. L putting away dialyzer for cleaning.

Treatment Area. The treatment area is where the patients receive their dialysis treatment. The nurses spend the majority of their shift here (57.13%). In the treatment area, nurses often set up or interact with the dialysis machine 33.33% of the time. Other activities include cannulation and decannulation (16.67%), monitoring and talking to the patient (14.58%), charting (12.5%) and other miscellaneous activities such as assisting the patient to the chair, weighing the patient, and checking the patient’s blood pressure (22.92%) (Table 10).

Table 10. REBA scores in the hallway area Number of occurrences 2 Average 5 Minimum 3 Maximum 7

The average REBA score for the area falls in the medium risk level range, which implies change is necessary and should be implemented. The highest REBA score in the shift also occurred here, and it was D who obtained that score. Her posture is seen below. Her back is almost perpendicular to the ground and her knees are bent.

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During the preliminary interview, the nurses critiqued the height of the patient chair stating that it was “too low” and many cited it as the cause of their back pain. It was found that the patient chair was replaced in October, and the nurses noticed their upper body pain worsening after the change. Both the old chair and the new chair were measured and it was found that the height from the ground to the armchair of the new patient chair was 10 cm lower than the old patient chair (Fig. 6).

Fig. 6. D fixing trashcan.

Most of the facility improvement suggestions from the nurses were also centered around the treatment area. Difficulty to reach one area of the clinic from another due to the large treatment space, small space between patient chairs, and inaccessibility of some items were other causes of concern (Table 11). Table 11. REBA scores in the treatment area (rounded to 2 decimal places) Number of occurrences 48 Average 4.96 Minimum 3 Maximum 10

6 Conclusion Based on the data and findings gathered, it can be concluded the furniture in the workspaces of the nurses is a factor in the pain that they experience. This includes having low desk space, low patient chairs, and having the patient chairs too close to one another.

7 Recommendations The high priority areas for improvement in the dialysis clinic are the nurse workstation and the treatment area, due to the number of ergonomic improvements that can be made and the long periods of time that nurses stay in these areas. Recommendations for the

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nurse workstation include increasing table height by 10–15 cm to provide adequate knee space for the nurses. For the treatment area, recommendations include increasing the height of the patient armrest and the chair in general by at least 10 cm. It is recommended however that the dialysis chairs be height adjustable. The layout of the dialysis station should also be changed so that each patient has at least 6 square meters of space, enabling the nurses to position themselves properly when assisting the patient.

8 Areas for Further Studies For future studies, other lifestyle and experience factors may be more strongly accounted for in assessing posture. Some examples of other factors include years of total experience in the medical field, frequency and type of exercise, and genetics. The study may also be applied to several dialysis clinics instead of only one. Furthermore, the effect of the workspace on body pain in nurses can be done for other nursing specializations.

References 1. Santa Monica College. (n.d.): How Do I Know If I Want to Become a Nurse? Accessed 25 Oct 2016, from Santa Monica College 2. Renal Nurses Association of the Philippines. (n.d.): Home. Accessed 10 Nov 2016 3. Philhealth.: List of philhealth accredited dialysis clinic as of 30 Jun 2016, Accessed 10 Nov 2016, from Philhealth, 30 Jun 2016 4. de Castro, A., Cabrera, S.L., Gee, G.C., Fujishiro, K., Tagalog, E.: Occupational health and safety issues among nurses in the philippines. AAOHN J. 57, 149–157 (2009) 5. Sherehiy, B., Karwowski, W., Marek, T.: Risk factors for musculoskeletal disorders in the nursing profession (2006) 6. Nelson, A.: Patient Handling in Health Care. CRC Press, 46-1–46-14 (2006) 7. Burns, K., Burrows, J.C., Nirenberg, L. (n.d.).: Hospital emergency room: ergonomic evaluations. http://ergo.human.cornell.edu/AHProjects/Hospital_Ergonomics/emergencyroom. pdf. Accessed 10 Nov 2016 8. ERGONOMIC WORKSTATION GUIDELINES (n.d.).: https://www.ncsu.edu/ehs/www99/ right/handsMan/office/ergonomic.html. Accessed 10 Nov 2016 9. Yasobant, S., Rajkumar, P.: Work-related musculoskeletal disorders among health care professionals: a cross-sectional assessment of risk factors in a tertiary hospital (2014) 10. Descatha, A., Roquelaure, Y., Chastang, J.-F., Evanoff, B., Melchoir, M., Mariot, C., Leclerc, A.: Validity of Nordic-style questionnaires in the surveillance of upper-limb work-related musculoskeletal disorders. Scand. J. Work Environ. Health 33, 58–65 (2010) 11. Hignett, S., Lynn, M.: Rapid entire body assessment. Appl. Ergon. 31, 201–205 (2000) 12. Motamedzade, M., Ashuri, M.R., Golmohammadi, R., Mahjub, H.: Comparison of ergonomic risk assessment outputs from rapid entire body assessment and quick exposure check in an engine oil company. J. Res. Health Sci. 11, 26–32 (2011)

Most Effective Exercise Load for Burning Body Fat with Aerobic Exercise in Young Japanese Women Tamaki Mitsuno(&), Miya Nagayasu, Yuko Shinohara, and Yui Ando Faculty of Education, Shinshu University, 6-ro, Nishinagano Nagano, Japan {mitsuno,8e1622k,9e1616j,10e16602d}@shinshu-u.ac.jp

Abstract. Physical exercise is important for limiting fat mass and preventing obesity. Aerobic exercise after breakfast is effective in helping to maintain lipid consumption. Study subjects were 18 young Japanese women who did not exercise regularly. They then engaged in 30 min of aerobic exercise with loads that were equivalent to 25%, 40%, 55%, 70%, and 25% of the maximum heart rate in sequential 6-minute intervals. Respiratory metabolism and heart rate were measured with a bicycle ergometer. The amount of energy, lipid, and carbohydrate consumed were calculated from respiratory quotients. Energy/carbohydrate consumptions and relative heart rates increased significantly compared with the resting control, which increased linearly as exercise load increased. However, lipid consumption was not different across exercise loads. Our findings show that aerobic exercise at a level to increase relative heart rate by 25% to 70% is effective in reducing body fat in women who do not exercise regularly. Keywords: Body fat
Lipid consumption
Energy consumption Carbohydrate consumption
Respiratory metabolism
Aerobic exercise Japanese young adult female
Oxygen intake
Heart rate





1 Introduction The main cause of illness-related death since World War II in Japan has changed to the geriatric diseases such as cancer, heart disease, and cerebrovascular disease from infectious diseases such as tuberculosis or pneumonia. The onset and progression of geriatric diseases have been considered to be attributed to aging; however, it has become clear that lifestyle is greatly related [1]. In addition, because the symptoms of these geriatric diseases have increased in children because of lifestyle factors [2], the name of geriatric diseases was changed to lifestyle-related disease in 1996 by the Ministry of Health, Labour and Welfare. One of the causes of lifestyle-related disease includes obesity, and it is said that approximately 90% of obesity is simple obesity. Obesity [3, 4] is considered a contributing factor to geriatric diseases such as diabetes [5], high blood pressure [6], dyslipidemia [7], myocardial infarction [8, 9], and cerebral infarction [10]. To prevent obesity and live a healthy life, we should be mindful of our eating habits and participate in regular exercise. In addition, it is necessary to keep body fat (BF) at an appropriate level. Excessive caloric intake [11] and lack of exercise © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_21

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contribute to reduced fitness and possibly long-term illness. Further, vigorous exercise is a considerably demanding task for a person unaccustomed to such activity. According to Mersy et al., aerobic exercise benefits health [12], which affects lipoprotein metabolism in sedentary healthy young women [13]. Thus, we used aerobic exercise in this study measured with an ergometer as a simple way to assess the work performed during exercise. This study aimed to identify easily achievable conditions that enhance BF metabolism during aerobic exercise by assigning moderate exercise in combination with normal eating habits [14–16].

2 Method 2.1

Subjects and Experimental Schedule

The study subjects were 18 healthy Japanese females in their twenties who did not normally participate in regular exercise. The physical characteristics and intensity of exercise loads of study subjects are displayed in Table 1. Subjects were non-smokers, with no history of systemic disease, and were not engaged in physical training or dietary programs. Respiratory metabolism was measured in the follicular phases of subjects’ menstrual cycles [17] in winter [18, 19]. Figure 1 illustrates the experimental schedule. Subjects awoke at 06:00 after 7 h of sleep and consumed a prescribed diet shown in Table 2 (breakfast typical for youth) until 07:00. They then entered a climate-controlled room (environmental temperature, 24.5 ± 0.3 °C; relative humidity, 50.3 ± 2.5%; lumination, 827 ± 27 lx; air current, 8.0 ± 0.1 cm/s) at 08:00. Subjects were seated at rest for 1 h while wearing a short-sleeved 100% cotton t-shirt and 100% polyester running pants. Their respiratory metabolism levels were measured by a Vmax-229 (Sensormedics, CA, USA) [20] using the breath-by-breath method for 40 min starting at 9:00. BF percentage, muscle, and basal metabolic rate (BMR) were measured using an electric bioelectrical

Table 1. Physical characteristics of the subjects Items

Age

Height Weight BMI

(Year) (m) Average 21.4 SD 1.2

1.59 0.07

(kg) 52.7 7.3

Topbust Waist girth (kg/m2) girth (cm) (cm)

Hip girth (cm)

Step1 Step2 Step3 Step4

20.8 2.4

93.6 4.5

27.5 7.3

86.4 3.9

70.1 5.0

Fig. 1. Schedule of experiment

Instnsty of Exercise (W)

39.2 12.5

56.7 8.2

69.4 8.0

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Table 2. Prescribed diet Food Weight Energy (Unit) (g) (Kcal) Bread 67.0 176.9 Strawberry jam 10.0 19.7 Butter 5.0 37.3 Instant coffee (Decaf) 5.0 14.4 Milk 50.0 33.5 Total 137.0 281.7

Water (%) 25.5 5.1 0.8 0.2 43.7 75.2

Protein (g) 6.2 0.1 0.0 0.7 1.7 8.7

Lipid (g) 2.9 0.0 4.1 0.0 1.9 8.9

Carbohydrate (g) 31.3 4.8 0.0 2.8 2.4 41.4

Ash (g) 1.1 0.0 0.1 0.4 0.4 2.0

impedance analysis [21] scale (BC-520, TANITA, Tokyo, Japan). Body weight was measured with a balance (IPS-150 K, Shimazu, Kyoto, Japan). Metabolism of BF was assessed by measuring respiratory metabolism before, during, and after aerobic exercise; the device used measured the amount of inhaled oxygen (L/min) and exhaled carbon dioxide (L/min) for every lungful of air. The energy consumption per one liter of oxygen (EC, kcal/O2l) was calculated from obtaining the respiratory quotient (RQ) [22, 23] using a Zunts-Schumberg-Lusk table [24], which shows analysis of the oxidation of mixtures of carbohydrate and fat. EC was calculated using the following equation: EC ¼ 1:22RQ þ 3:83 ðthe unit: kcal/O2 lÞ

ð1Þ

This was used to determine the EC ratio supplied from carbohydrate versus lipid metabolism. For example, the carbohydrate ratio Z for EC is determined from this equation: Z ¼ 317:14RQ  221:81

ð2Þ

while the lipid ratio X is calculated as: X ¼ 100  Z:

ð3Þ

Therefore, the amount of energy consumed (kcal/O2l) during respiration was divided into the relative ECs (kcal/min) supplied by carbohydrates (CC) or lipids (LC) using oxygen intake (L/min). Afterward, the carbohydrates and lipids metabolized during respiration were calculated using the relationship of 4.1 kcal per gram of carbohydrate and 9.3 kcal per gram of lipid.

2.2

Exercise Program

The exercise load of the exercise bike (Aerobic Exercise Ergometer, STB-1400, NIHONKHODEN, Tokyo, Japan) is shown in Fig. 2. Subjects engaged in 30 min of aerobic exercise with loads that were equivalent to 25%, 40%, 55%, 70%, and 25% of the maximum heart rate using the Karvonen equation [16, 25] in sequential 6-minute

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intervals (the second 25% interval served as a cool-down period). Respiratory metabolism and heart rate were measured during exercise and 5 min before and after as a control. EC, LC, and CC were calculated from RQs.

2.3

Lipid and Carbohydrate Metabolism

A typical example of the relationship between oxygen intake (OI) and carbon dioxide output using the breath-by-breath method is shown in Fig. 3, with dots representing the number of breaths. No points were detected that exceeded the anaerobic threshold (AT), confirming that these exercises were aerobic. According to Rennie et al., heavy exercise and long-term exercise resulted in the consumption of body protein in men [26]. The RQs in the present study were regarded as “non-protein RQs,” as the exercise was carried out at light loads and the 30-minute exercise duration was relatively short. Further, the subjects did not eat a lot of protein [27] (see Table 2). CCs and LCs were then calculated according to the fix rule [28, 29] and compared with each exercise load.

Fig. 2. Exercise load of exercise bike for 30 min

2.4

Fig. 3. Relationship between oxygen uptake and carbon dioxide emission

Perspiration and Insensitive Perspiration Amount

Body weights while wearing clothes were measured by a balance before and after exercise, and the increased weight of the clothes post-exercise was attributed to perspiration. The weight of the sweat was deducted from the loss of body weight over the exercise period to determine the amount of insensitive perspiration.

2.5

Statistics

ECs, CCs, LCs, and relative heart rates (RHR) measured before exercise at rest were compared with those from each exercise stage using a paired t-test in consideration of individual differences. Significant findings between each exercise stage were confirmed

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in EC, CC, and RHR from stages 1–4 after analysis by one-way ANOVA and examining significant differences using Tukey’s method. The correlation coefficients between EC and LC in each stage and the following relative factors were calculated: weight, sweat, insensitive water loss, BF, muscle, BMR, CC, LC, OI, and RHR were calculated. From the respiration metabolism determined by the breath-by-breath method, the averages of EC, CC, LC, and RHR were calculated every 10 s. The data collected in this way were analyzed by path analysis using LC as a dependent variable and OI, RHR, and CC as independent variables (IBM SPSS Ver. 22, Armonk, NY, USA).

3 Results 3.1

Effects on Energy Metabolism

A typical example of EC, CC, LC and RHR every 10 s is shown in Fig. 4. The variation of the CC and RHR resembled the variation of the EC (which changed by exercise stage), but was different from the variation of the LC. Therefore, these data were distributed and compared across each exercise stage.

Fig. 4. A typical example of energy, carbohydrate, and lipid consumption

EC, CC, LC, and RHR values for each stage compared with resting measurements are shown in Fig. 5. EC, CC, and RHR for each exercise stage and after exercise were significantly increased compared with each measurement before exercise (paired t-test). EC, CC, and RHR significantly increased during aerobic exercise in comparison with resting state. The significant findings between each exercise stage are shown in

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Fig. 5. EC, CC, LC, and RHR for each stage compared with resting measurements (*: P < 0.05, **: P < 0.01, ***: P < 0.001)

Table 3. Significant differences between each stage as shown in Fig. 5. Stage Energy Carbohydrate Lipid 1–2 0.000 *** 0.000 *** 1.000 N.S. 1–3 0.000 *** 0.000 *** 1.000 N.S. 1–4 0.000 *** 0.000 *** 1.000 N.S. 2–3 0.000 *** 0.001 ** 1.000 N.S. 2–4 0.000 *** 0.000 *** 1.000 N.S. 3–4 0.001 ** 0.005 ** 1.000 N.S. (*: P < 0.05, **: P < 0.01, ***: P < 0.001)

RHR 0.000 0.000 0.000 0.000 0.000 0.000

*** *** *** *** *** ***

Table 3. EC, CC, and RHR increased significantly and linearly with exercise intensity. Conversely, for LC, no significant differences were found. Table 4 displays the correlation coefficients between EC and LC in each stage and selected relative factors: weight, sweat, insensitive water loss, BF, muscle, BMR, CC, LC, OI, and RHR. There were significant positive correlations between EC and weight, sweat (except E1: EC in stage 1), insensitive water loss, BF, muscle, BM, CC, LC, and OI. Conversely, there was no significant correlation between LC and other factors except BF and OI in stage 1. This result showed that increased LC was not obtained even if the intensity of exercise was increased. That is, it was not necessary to increase the exercise load to burn BF with aerobic exercise.

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Table 4. Correlation coefficients between EC and LC in each stage and selected relative factors.

( *: P

Betätigen der OK-Funktion

Wahrnehmen, dass Cancel zum Verlassen des „Selection Mode“ führt

[ ]>>

Verstehen der CancelFunktion am Joystick

[ ]>>

Betätigen der Cancel-Funktion

[ ]>>

Bestätigte Funktion wird auf Bedienelement angezeigt

[ ]>>

Cancel

[ ]>> [ ]>>

Vorige Belegung wird auf der GUI angezeigt

Ende Selection Mode Anfang Working Mode wahrnehmen

Single Button (digital)

[]

[ ]>>

Verstehen, dass Working Mode aktiv ist

[ ]>>

Abrutschen aufgrund zu hoher Lage des Joysticks

Fußschalter auf Dauer schwerer gestalten

Icons und Schriftzug auf Bedienelement wahrnehmen

[ ]>>

Icons und Schriftzug verstehen

Single Blue (digital)

[]

Falls visuell: Farben und Anordnung des Bedienelementes verstehen

[ ]>>

Pedalposition wahrnehmen

[ ]>>

[ ]>> Falls haptisch: Position und Form des Bedienelementes verstehen

Betätigen des jeweiligen Bedienelement

Beim Betätigen des Buttons besteht die Gefahr, andere Bedienelemente zu berühren

Trennwand minimal erhöhen

Akustische Feedback an den Bedienelementen

Haptisches Feedback an den Bedienelementen

Visuelles Feedback durch grüne Umrandung auf der GUI

Hebel am Joystick verkürzen

Wegrutschen des Fußschalters wegen seitlicher Bewegung

Gumminoppen unter Fußschalter anbringen

Fig. 8. Overview of the mAIXuse Analysis

The areas of the GUI have not changed extremely, but it is mentionable that the presets are no longer to be found at the right sight of the big foot switch area, but instead on the bottom as the single selection are of the previous model 2.0. As mentioned before, Table 1 shows the identified functions and their possible assignments to the control

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elements on the universal foot switch 3.0. In general, the target was to maintain the functions in the original arrangements, in case a foot switch for a single device exists such as a shaver for orthopedic procedures, a milling device for ENT procedures and a HF-device and its corresponding foot switch. 3.3 Pre-evaluation Using the mAIXuse Method Figure 8 shows an overview of the complete pre-evaluation risk analysis which has been conducted to identify risks before the actual evaluation with surgeons would be performed. This computer assisted work-sequence, time line and risk analysis is based on using a tablet based CURE process recording tool and human error risk analysis method (CURE – Center for Usability and Risk Engineering (Aachen, Germany)). The CURE human risk analysis is based on the mAIXuse method developed at the Chair for Medical Engineering at the RWTH Aachen University. It refers to formal, normative models with the purpose of predicting user-, interaction- and system-behavior. Using specific task categories and setting up temporal relations between the specific tasks, any process can be modelled and human errors can systematically be identified [12]. Those errors implicated the urgency of changing minor hardware and software related aspects of the GUI and the universal foot switch such as changing the color of the mode button or giving a visual feedback on the GUI when confirming an assignment. Other changes of the last model seen from the hardware-technical side were to color the area around the joystick to emphasize its double function in this foot switch model. Furthermore, on the software side, some actions of confirmation, denial or toggling on the GUI came out to be crucial and thus have been changed in the new model after this analysis.

4

Evaluation

As a last step of the development process of the universal footswitch and the corre‐ sponding GUI concept, the final evaluation has been conducted within an interactioncentered usability analysis where the usability criteria effectiveness, learnability and user satisfaction have been analyzed. During a Wizard-of-Oz experiment, the thinking Aloud technique has been used on 9 surgeons from orthopedics, neurosurgery and ENT. The test setting can be seen in Fig. 9. To identify the type of errors and to quantify them for further analyses, the subjects’ feet-device interactions were recorded by a camera. The test design included 4 working tasks, which were (1) adjustment of the foot switch in “preset mode”, (2) assigning the joystick with various functions in the “single selection mode” (two times after each other) and (3) releasing functions in a predefined order. After having performed the practical tasks, the users needed to fill out a ques‐ tionnaire which contained SUS usability analysis questions [13] and other relating ques‐ tions which could give a better insight into the users’ opinion. The effectiveness of the system has been measured by the ratio of correctly fulfilled tasks to use errors. The learnability has been identified by the effectiveness of repeated tasks with a different focus meaning that the transferability could lead to a better learn effect. Regarding the effectiveness errors in the fulfilment of the tasks “release the single

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Laptop Investigator

Working Table Investigator

Camera

Universal Footswitch

OR table

S

Screen (48“ Philips)

I = Investigator S = Subject

Fig. 9. Test setting

selection mode”, and “cancel or confirm the actual function assignment” occurred in the first task cycle (of four cycles). A very high learnability of 100% could be examined in the last (fourth) cycle, in which the tasks have been fulfilled to 100%. Regarding learn‐ ability 83.25% of the subjects stated that the usage of the universal foot switch is easy to learn. An average of 77,2% of users rated the usability of the universal foot switch between good and excellent on the SUS scale (a value above 68% in the SUS scale constitutes good usability). The intuitiveness of the graphical user interface has been approved with 91.75% and the controllability of the system has been rated with 83.25%. In addition, on average 83.25% of the subjects confirmed that the work tasks could be carried out to their satis‐ faction. The user satisfaction is i.a. confirmed by the question, whether the users like to work with the system. Here, 86% of the subjects stated a high user satisfaction.

5

Conclusion and Outlook

The novel concept of a universal foot switch presented in this paper has been developed for the use in the ENT, orthopedic and neurosurgery OR. Due to the varying require‐ ments in these three disciplines, it has been challenging to include all specifications for different contexts of use. Especially the high number of different devices and functions and the altering use concepts of the devices led to special developmental detours, such as the cover for risk-critical functions. As a result of the development process, a generally well evaluated universal food switch and GUI were the outcome of the work presented of this paper. Nevertheless, due to the high number of different devices and functions, it is to mention that the complexity might need to be reduced in further studies by developing a foot switch for each discipline based on a modular kit of control elements and a basic foot switch. The universal foot switch has been measured regarding effectiveness, learnability and user satisfaction. Especially since the evaluation has been conducted in a Wizard of Oz-testing, some gaps between the current and the ideal GUI have been identified. Additionally, some obvious hardware changes such as changing the distance of arrange‐ ments and others are the outcome as handling suggestions for the future to improve the universal foot switch. In this context, especially the interaction with the joystick has shown major weaknesses regarding its height and its way of moving. Another negative

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outcome regarding the joystick was that the force to release the joystick has been insuf‐ ficient, which resulted in the surgeons’ uncertainty regarding the haptic feedback after certain actions. Regarding the assignments of the joystick, it needs to be rethought that the confirmation and cancel function should be changed to make the use of the joystick more intuitive. To summarize, the concept of a universal foot switch and the GUI design brings some major challenges with it and makes the assumption possible, that future studies should focus on the reduction of complexity using discipline-related foot switches. Thus, modular tendencies concerning the development of the foot switch could be focused on in the future.

References 1. Blaar, M., Janß, A., Dell’Anna, J., Höllig, A., Radermacher, K., Clusmann, H.: Bottlenecks and needs in human-human and human-machine interaction - a view from and into the neurosurgical OR. J. Biomed. Eng. 61(2), 135–146 (2015). Dössel, O. (ed.) 2. Afkari, H., Eivazim, S., Bednarik, R., Mäkelä, S.: The potentials for hands-free interaction in micro-neurosurgery. In: Proceedings of the 8th Nordic Conference on Human-Computer Interaction: Fun, Fast, Foundational, pp. 401–410 (2014) 3. Koneczny, S., Matern, U.: Instruments for the evaluation of ergonomics in surgery. Minimally invasive therapy & allied technologies 13(3), 167–177 (2004). MITAT: official journal of the Society for Minimally Invasive Therapy 4. Van Veelen, M.A., Snijders, C.J., Van Leeuwen, E., Goossens, R.H.M., Kazemier, G.: Improvement of foot pedals used during surgery based on new ergonomic guidelines. Surg. Endosc. 17(7), 1086–1091 (2003) 5. Kasparick, M., Schlichting, S., Golatowski, F., Timmermann, F.: Medical DPWS: New IEEE 11073 standard for safe and interoperable medical device communication. In: 2015 IEEE Conference on Standards for Communications and Networking (CSCN) (CSCN 2015), Tokyo, Japan, pp. 223–228 (2015) 6. Niederlag, W.: Der digitale Operationssaal. De Gruyter (Health academy), Berlin (2014) 7. Stryker GmbH & Co. KG: Foot-operated control console for wirelessly controlling medical devices. Patent registered on 27.06.2003. Registration number: US 10/607,810. Publication number: US20080140158 A1 (2003) 8. Steute Schaltgeräte GmbH & Co. KG: Multifunktions-Fußschalter. Patent registered by steute Schaltgeräte GmbH & Co. KG on 15.10.2008. Registration number: DE202008013551U1. Publication number: DE202008013551U1 (2008) 9. Dell’Anna, J., Janß, A., Clusmann, H., Radermacher, K.: A configurable foot switch unit for the open networked neurosurgical or – development. Eval. Future Perspect. i-com 15(3), 227– 247 (2016) 10. Theissing, J.: HNO -Operationslehre. 4. Georg Thieme Verlag KG, Stuttgart (2006) 11. Ewerbeck, V., Wentzensen, A., Grützner, P.A., Holz, F.: Standardverfahren in der Operativen Orthopädie und Unfallchirurgie. Georg Thieme Verlag KG, Stuttgart (2014) 12. Janß, A., Plogmann, S., Radermacher, K.: Human centered risk management for medical devices - new methods and tools. J. Biomed. Eng. Biomed. Tech. 61(2), 165–181 (2016) 13. Brooke, J.: SUS: a “quick and dirty” usability scale. In: Usability Evaluation in Industry. Taylor and Francis, London (1986)

Effects of Noises and Music on Nurses’ Mental Workload and Situation Awareness in the Operating Room Li-Ping Tseng1 and Yung-Ching Liu2(&) 1 Department of Management Center, St. Martin De Porres Hospital, Chiayi, Taiwan [email protected] 2 Department of Industrial Engineering and Management, National Yunlin University of Science and Technology, 123 University Road Section 3, Douliu, Yunlin 640, Taiwan [email protected]

Abstract. Noise exposure is a common operating room (OR) phenomenon. Music is often regarded as a useful tool to relieve stress and energize lagging attention levels. Surgical teams, therefore, often listen to music when they conduct operations. However, these noises may impact surgical outcomes and patient safety. Focusing on nurses, this study aims to determine the association of sound volumes, state anxiety, mental workload and situation awareness when nurses assist in the operating room. A total of 40 circulating nurses and 40 anesthesia nurses participated in the study. The experiment was designed by 4 between subjects (without music, songs with Chinese lyrics, FM pop music broadcasting and Mozart’s music) and 2 within subjects (55–60 dB and 75– 80 dB), and adopted a subjective rating technique to investigate the participants’ state anxiety, mental workload and situation awareness during the surgical process. The results showed that the participants maintained a high level of situation awareness. The degrees of mental workload revealed statistically significant differences when specific tasks, especially surgical time-out, needed to be carried out. Sound volume was reported as a major factor that caused great state anxiety among circulating nurses. By listening to Mozart music, the participants significantly decreased their mental workload, increased situation awareness and relieved stress to achieve positive reaction. In addition, mental workload was positively correlated to state anxiety among circulating nurses. Finally, some implications and further suggestions are provided. Music volume should be controlled since it significantly affects mental workload and state anxiety. Noises produced from medical equipment and instruments need to be decreased; maintaining sound volume less than 60 dB is recommended. Moreover, developing a low volume music environment during an operation will be beneficial to both occupational health and patient care outcomes. Keywords: Machinery noises in the operating room
Music in the operating room
Nurses’ mental workload
Nurses’ situation awareness
Nurses’ state anxiety

© Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_46

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1 Background and Research Purpose Surgical teams are often exposed to machinery noises from medical equipment and instruments in the operating room; hence they often rely on music to soothe the irritating noises during the surgical process. However, it is feasible that both noise exposure and the use of music may influence surgical outcomes and therefore deteriorate patient safety. In the operating room, nurses are trained to assist surgeons and care for patients during both routine and difficult surgical procedures. In order to constantly keep their situation awareness, nurses have been reported to bear heavy workload during the surgical process [1]. Due to nurses’ major assisting and caring characteristics, this study aims to determine the association of sound volumes, state anxiety, mental workload and situation awareness when nurses are involved in the surgical procedures.

2 Methods A total of 40 circulating nurses and 40 anesthesia nurses in 40 surgeries participated in the study. All participants were asked to answered SAGAT and SWAT Questionnaire on four essential particular periods–counting, surgical time-out, operation on 60 min, and wound closure–in which nurses performed specific tasks for operation. STAI-S was distributed to the participants to complete within 60 min after operation. Detailed descriptions about each research instrument are shown in Table 1. The experiment was designed by 4 between subjects (without music, songs with Chinese lyrics, FM pop music broadcasting and Mozart’s music) and 2 within subjects (55–60 dB and 75–80 dB), and adopted a subjective rating technique to investigate the participants’ state anxiety, mental workload and situation awareness during the surgical process. Data analyses included two-way repeated-measure ANOVA, one-way ANOVA and Pearson correlation analysis by SPSS 18.0. Table 2 illustrates the factors investigated in the current study.

3 Results The results showed that the participants maintained a high level of situational awareness. The degrees of mental workload revealed statistically significant differences when specific tasks, especially surgical time-out, needed to be carried out. Table 3 summarizes the results of two-way repeated-measure ANOVA of mental workload on four particular periods. Sound volume was reported as a major factor that caused great state anxiety among circulating nurses. Table 4 summarizes the results of one-way ANOVA of all dependent variables (SA, SWAT and STAI-S) for type of surgery, auditory condition and sound level. During the period of playing Mozart’s music, the participants significantly decreased their mental workload, increased situation awareness and relieved stress to achieve positive reaction. In addition, mental workload was positively correlated to state anxiety among circulating nurses. Table 5 shows the correlation analysis of situation awareness, mental workload and State-Trait Anxiety among circulating nurses.

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Instrument Sound level meter

Type 1353L sound level meter

Purpose The sound level meter was used to measure sound levels during operation

(TECPEL, Taiwan)

HP computer and loudspeaker

The HP computer and loudspeaker were used to play songs with Chinese lyrics, FM pop music broadcasting and Mozart’s music

SAGAT

Questionnaire of situation awareness global assessment technique

SWAT questionnaire

Questionnaire of subjective workload assessment technique

STAI-State

State-trait anxiety inventory

SAGAT is a tool for assessing the participants’ situation awareness, including Level 1 (perception of data), Level 2 (comprehension of meaning) and Level 3 (projection of the near future) components SWAT, including 3 indicators: time load, mental effort load, and psychological stress load, was used to investigate the participants’ mental workload STAI is a tool for measuring trait and state anxiety [2]. In this study, the STAI-S was used to evaluate caregiver distress

Music player

Table 2. Summary of factors in the experimental design (4  2). Factors/Participants Circulating nurses Anesthesia nurses Between subjects Without music Songs with Chinese lyrics FM pop music broadcasting Mozart’s music Within subjects 55–60 dB 75–80 dB

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Table 3. Two-way repeated-measure ANOVA of mental workload on four particular periods Subject Variable 4 particular periods (A) 4 particular periods (A)  Type of surgery (B) 4 particular periods (A)  Auditory condition (C) 4 particular periods (A)  Sound level (D) * p < .05, ** p < .01.

Circulating nurses SS df MS 19.09 3 6.36 10.90 6 1.82

F 5.00* 1.42

Anesthesia nurses SS df MS 26.89 3 8.96 5.34 6 .89

23.25

9

2.58

2.03

9.62

9

1.07

1.44

4.00

3

1.33

1.05

2.44

3

.82

1.10

F 12.06** 1.20

Table 4. One-way ANOVA of all dependent variables (SA, SWAT and STAI-S) for type of surgery, auditory condition and sound level Variable Type of surgery

Subject SA SS

CN NA Auditory CN condition NA Sound level CN NA

.16 2.76 1.86 8.61 3.92 2.26

df MS 2 2 3 3 1 1

F

SWAT SS df MS

7.82 24 66.00 2 1.38 .54 83.38 2 .63 2.14 121.40 3 2.87 1.62 209.50 3 3.92 .12 635.20 1 2.26 .90 494.39 1

F

STAI-State SS df MS

33.00 1.29 12.99 2 41.70 1.82 79.13 2 40.46 1.63 246.25 3 69.83 3.48* 180.83 3 635.20 63.45** 188.61 1 494.39 42.93** 37.44 1

6.50 39.57 82.08 60.28 188.61 37.44

F .19 1.80 2.90* 3.05* 6.65* 1.67

CN: Circulating nurses. NA: Anesthesia nurses. * p < .05, ** p < .01.

Table 5. Correlation analysis of situation awareness, mental workload and state-trait anxiety among circulating nurses Variable

SA Pearson P SA 1 SWAT −.05 .74 STAI-State −.16 .33 ** p < .01.

SWAT Pearson P −.05 .74 1 .65** .00

STAI-State Pearson P −.16 .33 .65** .00 1

4 Conclusion and Recommendations The results of the study have provided important consideration for future constructing medical standard operating procedures (SOP) in the operating room. Since sound volume affected mental workload and state anxiety, the music volume should be controlled. Considering the fact that machinery noises are needed to maintain adequate alarm functions, the noise produced from medical equipment and instruments can’t be

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avoided. But there is a strong need to lower the volume. Controlling sound volume less than 60 dB is recommended, especially after surgical time out. Moreover, Mozart effect is notably applied to reduce mental workload and state anxiety. Developing a low volume music environment during an operation will be beneficial to both occupational health and patient care outcomes. Acknowledgements. The authors expressed their gratitude to the Ministry of Science and Technology for their financial support (under the contract no. 105-2221-E-224-025).

References 1. Carayon, P., Gurses, A.: Nursing workload and patient safety—a human factors engineering perspective. In: Hughes, R.G. (ed.) Patient Safety and Quality: An Evidence-Based Handbook for Nurses. Agency for Healthcare Research and Quality (US), Rockville (2008) 2. Spielberger, C.D., Gorsuch, R.L., Lushene, R., Vagg, P.R., Jacobs, G.A.: Manual for the State-Trait Anxiety Inventory. Consulting Psychologists Press, Palo Alto (1983)

Preliminary Study of Ontological Process Analysis of Surgical Endoscopy Kazuhiko Shinohara ✉ (

)

School of Health Sciences, Tokyo University of Technology, Tokyo 1448535, Japan [email protected]

Abstract. Ontological investigation has been applied to the health care field in several areas, such as disease terminology, medical service, and clinical guide‐ lines. However, few reports have adopted an ontological approach to surgical procedures. This study applies ontological analysis to the procedure of surgical endoscopy. Physician actions during gastrointestinal endoscopy were decom‐ posed and classified from upper-level to sub-class concepts by an ontological approach. Each upper-level concept was then subdivided into further sub-class concepts. In this way, the procedures for gastrointestinal endoscopy were success‐ fully classified within ontological concepts. Ontological analysis and description of surgical procedure can be applied in many areas, including medical education, training, ergonomic evaluation, workflow management, and development of endoscopic robotics and simulators. However, difficulties remain in mapping concurrencies and in repetitive processing. Also, the ontological analysis of some complicated and troublesome procedures should be improved. The need for computer software that provides simple and easy analysis of surgical procedures was made clear in this study. Keywords: Ontology · Surgical endoscopy · Workflow analysis

1

Introduction

Artificial intelligence has received increased attention recently in various domains, and application of artificial intelligence to clinical medicine has received particular interest. For artificial intelligence to be applied to human activities, ontological analysis is neces‐ sary. However, few reports have adopted an ontological approach to surgical procedures. This study suggests a method of ontological analysis for surgical endoscopy and inves‐ tigates the feasibility of and problems with applying an ontological approach to clinical surgery.

2

Material and Methods

Physician actions during trans-nasal gastrointestinal endoscopy were decomposed and classified from upper-level concepts into sub-class actions with reference to the concept of an ontological approach. The endoscopic procedure was decomposed into the © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_47

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following items as upper-level concepts of “What to achieve”: “Insertion,” “Observa‐ tion,” “Recording,” “Biopsy,” “Resection,” “Hemostasis,” “Specimen retrieval,” and “Withdrawal of the endoscope.” The procedure was also decomposed into the following items as upper-level concepts of “How to achieve”: “Push,” “Pull,” “Tilt,” “Bend,” “Inflate,” “Deflate,” and a few others. Each upper-level concept was then subdivided into further sub-class concepts. The flows of the procedure are described in reference to ontological analysis technique (Figs. 1 and 2).

Fig. 1. Endoscopic view of trans-nasal insertion of gastrointestinal endoscope

Fig. 2. Endoscopic view of the stomach

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Results

Flows of the procedure are described as follows. Physician actions from insertion to withdrawal of the endoscopy are shown in Figs. 3 and 4.

Fig. 3. Work flow of gastrointestinal endoscopy 1

Flows of “biopsy” and “endoscopic polypectomy” are shown in Figs. 5 and 6. The procedures for trans-nasal gastrointestinal endoscopy were successfully classified and described by applying ontological analysis. However, difficulties remain in describing concurrencies and repetitive processing as well as mutual interaction among physician, nurse, and medical devices.

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Fig. 4. Workflow of gastrointestinal endoscopy 2

Fig. 5. Work flow of “Biopsy”

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Fig. 6. Work flow of “Endoscopic polypectomy”

4

Discussion

Application of artificial intelligence to clinical medicine has been attempted many times, starting in the 1960s. Automated analysis of laboratory data and medical imaging has been achieved in several domains of medicine. In recent years, artificial intelligence has attracted renewed interest in various industries, and applications of artificial intelligence to medicine are being widely discussed again. Against this background, ontological investigations of medical domains are proposed. A semantic approach is expected to provide logical and effective uses for huge amounts of clinical data [1]. An ontological approach to medical domains has been reported in the field of disease terminology, automated analysis of medical diagnosis (including gene and blood exami‐ nations), medical service, and clinical guidelines. Several ontologies (e.g., OGEM, POID [2, 3]) have been proposed for medical information systems, focusing on onto‐ logical definitions of disease. In the field of clinical guidelines, several ontological research studies have been conducted and computer-interpretable ontological guidelines based on existing clinical guidelines have been developed [4]. Nishimura et al. [5] reported ontological activity models for application to nursing guidelines for integrated use by the CHARM model created by OntoGear, a commercial software package by MetaMoji Co. Despite these advances, ontological analysis has not previously been applied to the activities of surgical endoscopy [6]. The ontological analysis of surgical endoscopy presented here is an early study. Despite the preliminary nature of this study, the procedures of trans-nasal

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gastrointestinal endoscopy for diagnosis and treatment were successfully classified and described, and the feasibility of taking an ontological approach to endoscopic surgery was demonstrated. Ontological analysis and description of surgical procedures could be applied in many areas, including medical training and evaluation, ergonomic analysis and management of surgical workflow, and basic research and development of endoscopic robotics and simulators. However, difficulties remain in mapping concurrencies and repetitive processing. The concepts of ontology and the supporting technology are ultimately logical, which is essential for application of artificial intelligence to the automation of the medical system. However, process of ontological analysis of some complicated matters has proved troublesome, particularly the application to intuitive human activities such as surgery and clinical therapies. In the field of clinical activities, surgery in partic‐ ular, the same kinds of difficulties with workflow analysis exist as in the application of other conventional method such as “motion analysis” in the field of industrial engi‐ neering and Failure Mode and Effect Analysis. These workflow analysis methods were originally developed for industry, and so if they are to see practical use in clinical activ‐ ities at hospitals and medical schools, certain simplifications will be necessary. Also, for the successful application of an ontological approach to clinical fields such as surgery, ergonomic and technological problems of ontological engineering itself should be resolved through further analysis of the workflow, considering the medical devices and surgical staff involved. Computer software that provides simple and easy analysis of surgical procedures is also necessary.

5

Conclusion

This study applies ontological analysis to the procedure of surgical endoscopy. Proce‐ dures of trans-nasal gastrointestinal endoscopy were successfully classified and described by reference to the ontological concepts. Ontological analysis and description of surgical procedure can be applied in many areas; however, some difficulties remain with complicated and troublesome procedures, and handle of these should be improved. The need for an ergonomic approach to ontological engineering and development of computer software that provides simple and easy analysis of surgical procedures was also revealed in this study.

References 1. Kozaki, K., et al.: Browsing causal chains in a disease ontology. In: Poster & Demo Notes of 11th International Semantic Web Conference, Boston, USA (2012) 2. Scheuermann, R., et al.: Toward on ontological treatment of disease and diagnosis. In: Proceedings of the 2009 AMIA Sumit on Translational Bioinfomatics, San Francisco, pp. 116– 120 (2009) 3. Osborne, J., et al.: Annotating the human genome with disease ontology. BMC Genom. 10(1), 56 (2009) 4. Kumar, A., et al.: An Ontological Framework for the Implementation of Clinical Guidelines in Healthcare Organization. Ontologies in Medicine. IOS Press, Amsterdam (2004)

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5. Nishimura, N., et al.: CHARM as activity model to share knowledge and transmit procedural knowledge and its application to nursing guiderlines integration. J. Adv. Comput. Intell. Intell. Inform. 17(2), 208–220 (2013) 6. Shinohara, K.: Ergonomic considerations on the implementation of small-caliber trans-nasal gastroduodenoscopy. In: Advances in Human Factors and Ergonomics in Healthcare, pp. 730– 735. CRC Press (2011)

Operating Room Ergonomics: A Practical Approach for Reducing Operating Room Ergonomic Hazards Yona Vaisbuc1, Justin M. Moore1, Robert K. Jackler1, and John Vaughan2 ✉ (

1

)

Stanford University School of Medicine, Stanford, CA, USA {yona,jmmoore,jackler}@stanford.edu 2 Stanford Health Care, Stanford, CA, USA [email protected]

Abstract. The role of ergonomics related to computer workstations and computer use is almost universally understood. Ergonomics in a setting such as an operating room where the well-being of the surgeon and other operating room (OR) staff can influence patient outcomes is rarely considered. This study utilized operating room personnel during ENT and Neurosurgery surgeries to identify ergonomic hazards and to organize the OR in ways that reduce the risk of muscu‐ loskeletal injury using ergonomic principles. We have chosen to develop the checklist using ENT surgeons as this group completes procedures in a wide variety of positions including standing or seated next to the robot, standing or seated at the microscope and endoscopic proceduralists. This makes the checklist tool adaptable to a wider variety of specialties. Ergonomics in the operating room is clearly essential considering the high rates of reported musculoskeletal pain among surgeons attributed to the operating room environment [1, 2]. Keywords: Ergonomics · Surgery · Health system · Procedures · Checklist

1

Introduction

The role of ergonomics as it relates to computer workstations and computer use is almost universally understood. Ergonomics related to procedures conducted in the healthcare setting, such as an operating room (OR), where evidence suggests it impacts the well‐ being of the surgeon, the OR staff and the patient, is rarely considered. This is despite the fact that such an impact has been recognized for over a century. It is also well docu‐ mented that the pain and fatigue that afflicts individuals performing health related procedures may affect not only the proceduralist’s health, but also can impact health institutions and patients. Several studies have reported that between 60–90% of surgeons report pain and discomfort from poor ergonomic positioning in the operating room. Of further concern is the fact that up to 40% of proceduralists report that pain and discomfort would influence their ability to perform or assist with surgical procedures in the future. Currently, two thirds of surgeons have no or only a slight awareness of the ergonomic factors contributing to their symptoms [1, 2]. Checklists have become standard practice in many institutions as a way to routinely reduce procedural complications [3]. However, this approach to reducing the pain and © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_48

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disability of work related procedures on health care workers has rarely been explored. In fact, to the authors' knowledge, there are no standards or implementation programs currently aimed at this health burden. We hypothesize that the development and imple‐ mentation of such a tool could reduce disability and improve productivity and satisfac‐ tion among operating room staff around the globe. This study will utilize Hospital settings to identify ergonomic hazards and to organize the working spaces (operating rooms and floors) in ways that reduce the risk of muscu‐ loskeletal (back, neck, upper extremity, etc.) injury using ergonomic principles. We have chosen to develop the checklist using ENT surgeons for reasons previously described. Using this cohort will make the checklist tool adaptable to a wider variety of specialties. Major goals: To improve the working habits of health care workers in order to reduce injuries, improve productivity and prevent future adverse health consequences in health professionals undertaking procedures (such as physicians, surgeons, Scrub tech, Nurses, Anesthesiologists, Transporters, etc.). Aim One: We will achieve this aim by validating a comprehensive ergonomic checklist developed by the authors designed to identify ergonomic hazards related to medical procedures in interventional suites and on the wards.

2

Materials and Methods

Literature search strategy utilized recommended guidelines for systematic review and meta-analyses. Electronic searches were performed using Ovid Medline, PubMed, Google Scholar, and Cochrane Database of Systematic Reviews (CDSR), from their dates of inception to March 2017. To achieve the maximum sensitivity of the search strategy, we combined the terms: “ergonomics”, “surgeon”, “postural”, “operating room” as either key words or MeSH terms. The reference lists of all retrieved articles were reviewed and assessed using the inclusion and exclusion criteria for further iden‐ tification of potentially relevant studies. Experts in ergonomics were consulted as to whether they knew of any unpublished data. Eligible studies for the present systematic review included those specifically looking at the ergonomic effects of surgeon position in the OR and possible interventions [3]. When institutions published duplicate studies with accumulating numbers of patients or increased lengths of follow-up, only the most complete reports were included for quan‐ titative assessment at each time interval. All publications were limited to those involving human subjects and in the English and Hebrew language. Abstracts, case reports, conference presentations, editorials, reviews and expert opinions were excluded. In addition to our literature review the authors used field observations within the OR to identify additional ergonomic factors for incorporation into the checklist.

3

Results

Components of the checklist include pre-procedure, intra-procedure and post procedure items, both general and role specific. Pre-procedural checklist components include assessing and evaluating different surgical postures (standing, sitting at/next to a

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microscope, robotic surgery, endoscopic surgery, bedside procedures), room arrange‐ ment, patient positioning, heath care worker position in respect to different anatomical sites. Intraprocedural components will include regular breaks and exercises. Post proce‐ dure checklist includes patient transfer components as well as after hours specifically tailored exercise recommendations. Pre-operative. The patient is wheeled into the OR by the porter team. The scrub tech‐ nician is already gowned and laying out the instruments prior to the patient’s arrival in the OR. The patient is then transferred from his ward bed across to the operating table utilizing the porter, anesthetic team and surgical resident. The patient is intubated by the anesthetic team, requiring the assistance of the video scope. Once intubated the patient is manipulated on the bed by surgical team. The surgical team then scrubs for the case, the primary surgeon is seated in front of the operative site and the microscope is prepared for use during the case.

4

Pre-operative Analysis

The Room. Operating table positioned inappropriately (too high or too low, not aligned with other equipment in the room). The position of the table in the room is important to enable both surgical team and the anesthetist access to the patient without having to reach. The operating table must also be positioned to align with the anesthetic equipment, scrub trolley, neuro-monitoring equipment, equipment towers (diathermy, suction. Drill). Microscope and TV monitors not in line with surgeon’s body causing contortions. TV monitors/Microscope must be positioned with consideration given to the location of the patient, the operative site, and where the surgeon is to stand or sit to ensure the monitor is in the line of sight of the surgeon. Operative site must be located appropriately on the table. Example: Abdomen should be in the center of the table while lateralized operative site (e.g. for ear) should be positioned closer to the operating surgeon. Anesthetic Tower and equipment can now be optimally positioned to allow adequate access to lines and tubes, minimizing awkward positions required to access this equipment. Scrub Technician. Bending over while preparing instruments and surgical attire for surgery- Frequent bending over instrument in the same position for many hours due to inappropriate height of scrub table. Organizing the Table. Discussion with the surgeon prior to beginning procedue to see which instruments will be utilized can reduce continuous reaching. Height of scrub table often not appropriate- Inappropriate scrub table height forces technician to bend and/or reach unnecessarily. (NOTE: Height adjustable scrub tables are available.) Anesthetic Team. Positioning the bed at the right height for the anesthetic team. Using video assisted intubation, the screen must be in line with the aesthetic line of sight to prevent prolonged bending.

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Surgeon. Chair not (or poorly) adjusted. Chair should be adjusted so the knees are at or near 90 degrees, feet should be flat on the floor, 90 degrees between the axis of the lumbar spine and hip. Microscope Adjustment. Microscope can now be adjusted so that the eye pieces are at the level of the eyes when the neck is in neutral posture (i.e., not flexed or extended). Next adjust the working distance of the microscope. Operating Table. Adjust the height and roll or tilt of the table to elbow level. If surgeon standing position the height should be at the elbow level; if seated, the knees should be accommodated beneath the table. (Note: Adjust the table to the primary surgeon.) Arm Rests. Once the table and surgeon are in position, the chair arms can now be adjusted so elbows are now supported in the position. (NOTE: Staff sitting at computer tables (or other tables) must be able to get their legs comfortably under the table. When using stools with manual screw-type height adjustment, the seat height may prevent this. Over time, gravity slowly lowers the seat, so these screw stools must be adjusted in both the preoperative and intraoperative phase. When possible, replace these stools with pneumatically adjustable ones.) Intraoperative. The case continues for approximately 5 h, during which time the surgeons work from the superficial structures to the deep structures. The drill is used extensively. During the dissection phase the surgeons utilize 5 different instruments for 80% of the procedure. The scrub nurse is continually giving different instruments to the surgical team. The circulating nurse, neuro-monitoring and anesthesiologist remain seat for major portion of the case.

5

Intra-operative Analysis

Every 30 to 45 min consider the following: • Surgeons are frequently in contorted position for long periods of time due to incorrect table, chair, and arm rest heights. Adjust these as appropriate. • Scrub technicians should reassess where key instruments are at regular intervals to minimize reaching over the table. Consider a step stool if the height of the bed is changed. • At regular intervals, the entire scrub team should take “mini breaks” and complete the appropriate exercises (these can be done while sterile). These breaks consist of 1.5–2.0 min interval with a set of targeted exercises which focus on the neck, back, shoulders and hands and lower extremities [4]. Post Operative. The final stitch is placed, the patient is extubated. The patient is trans‐ ferred from the operating table onto the bed. The patient is then wheeled to the recovery room.

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Post Operative Analysis

6.1 Equipment After surgery, the patient is transferred from the operating table to a bed or gurney for transport to the recovery room. Ensure that both table and bed are at the appropriate heights. The bed or gurney should be positioned slightly lower that the operating table, to utilize gravity during the transfer. Transfer aides such as HandyTube, Z-slider, etc., may be utilized. The surgical team should do some post operative exercises, particularly stretching, to help muscles recover from long periods of static exertion. This may be done imme‐ diately after surgery at the hospital or later at home [4] (Table 1). Table 1. OR ergonomic checklist Checklist Item Pre-Operative Room setup

Example

Operating table

Position in room allowing access for surgical, anesthetic and scrub teams Balanced and in a position that allows full maneuverability Position so that proceduralists to visualize monitor without rotating the head Specific case related requests Should be positioned so operative site is close to surgeon Positioned to allow adequate access to lines and tubes

Microscope Monitor

Completed (Y/N)

Equipment Patient Anesthetic Tower Personnel Scrub Technician Instrument position, height of scrub table, mat on floor, microscope cover sheet Anesthetic Team Bed height positioned to optimize intubation Surgeon Adjust chair back rest, arm rest and height, microscope, and operating table Intra-Operative Completed every 45 min Surgeon Chair, Table, foot pedal, arm rests and operating table, drill and scope grip Scrub Technician Reassess which instrument are going to be on frequent rotation and position them appropriately The operative All members should have mini breaks every 45 min team Post-Operative Equipment Adjust table and trolley to maximize gravity use for transfer Surgical staff Short Exercise session

Operating Room Ergonomics

7

467

Discussion

Several previous studies have demonstrated the need of ergonomic consideration in reducing OR hazards [5]. Some have also shown that there are two general impediments to implementing OR ergonomics programs. The first is a general lack of knowledge among surgeons regarding ergonomi c principles. The other is the absence of a system‐ atic approach to adjusting the room. Implementing a successful ergonomic program for the operating rooms first requires a survey of the existing situation. This paper describes a comprehensive survey checklist developed by the authors designed to identify OR ergonomic hazards. The initial focus in on areas where modification to the physical set up; i.e., OR equipment including the operating table, the surgeon’s chair, viewing monitors, location of personnel, vitals monitoring equipment, etc. We further looked at whether the employee’s (surgeon, nurse, anesthetist) stature was accommodated by the arrangement. Our study identified many instances of ergonomic mismanagement. Most of the OR personnel were not even aware of the ergonomic risk factors they were encountering. Importantly our literature review and field observation identified several reoccurring problems, such as operating table height adjustment, and our checklist provides a means of identifying and mitigating these problems. The checklist was designed to remind the surgical team to regularly assess and utilize adjustable equipment through a clear sequence of steps With one operating room table, it is rarely possible to adjust it to accommodate all members of the surgical team. During our observation of surgical procedures, we saw teams ranging in height from barely five feet (5’) to six feet five inches (6’5”). In most instances the table height should be adjusted for the lead surgeon. It also became clear that it was much easier to accommodate more of the team if the surgery was performed from a seated position. Another aspect of OR ergonomic implementation that wasn’t covered in detail but should be considered as part of a full ergonomic intervention program is personal protective equipment (PPE) such as eye and hearing protection. Other aspects of personal safety, like avoiding sharps injuries by utilizing a safety zone to pass needles and scalpels rather than passing them directly between scrub technicians and surgeons. An upcoming study will seek to validate our checklist through staff surveys and propose further enhancements to help ensure compliance with ergonomic recommen‐ dations.

8

Conclusion

By utilizing easily understood ergonomic procedures and raising ergonomic awareness, together with a constructive implementation program, both safety and efficiency of the surgical team and the OR suite are enhanced. That said, improvements in both proce‐ dures and equipment are needed. One such equipment improvement that is ready for testing is a digital microscope. The current ocular microscopes must be near the patient for greater clarity due to the focal length. For the surgeon, this frequently means being

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in an awkward position leaning forward from the waist, arms outstretched, with head and neck in a backward flexed position to look through the binoculars. The digital microscope does away with the binoculars and instead has the surgeon performing the procedure while watching a 3D screen without the need to stretch the neck or upper extremities due to limits incurred by focal length.

References 1. Davis, W.T., Fletcher, S.A., Guillamondegui, O.D.: Musculoskeletal occupational injury among surgeons: effects for patients, providers, and institutions. J. Surg. Res. 189(2), 207–212 (2014) 2. Park, A., Lee, G., Seagull, F.J., Meenaghan, N., Dexter, D.: Patients benefit while surgeons suffer: an impending epidemic. J. Am. Coll. Surg. 210(3), 306–313 (2010) 3. Haynes, A.B., Weiser, T.G., Berry, W.R., Lipsitz, S.R., Breizat, A.H.S., Dellinger, E.P., Herbosa, T., Joseph, S., Kibatala, P.L., Lapitan, M.C.M., Merry, A.F.: A surgical safety checklist to reduce morbidity and mortality in a global population. N. Engl. J. Med. 360(5), 491–499 (2009) 4. Hallbeck, M.S., Lowndes, B.R., Bingener, J., Abdelrahman, A.M., Yu, D., Bartley, A., Park, A.E.: The impact of intraoperative microbreaks with exercises on surgeons: a multi-center cohort study. Appl. Ergon. 60, 334–341 (2017) 5. Baumgart, A., Neuhauser, D.: Frank and Lillian Gilbreth: scientific management in the operating room. Qual. Saf. Health Care 18(5), 413–415 (2009)

Incorrect Surgery and Invasive Procedures: Internet Videos Fail to Depict the Full Story Douglas E. Paull1,2,3, Robert Kononowech1, Sarah Simpson1(&), David M. Sine1, and Robin R. Hemphill1 1

Veterans Administration National Center for Patient Safety, Ann Arbor, MI, USA {Douglas.Paull,Robert.Kononowech,Sarah.Simpson2, David.Sine,Robin.Hemphill}@va.gov 2 Georgetown University School of Medicine, Washington, D.C., USA 3 Department of Surgery, University of Michigan, Ann Arbor, MI, USA

Abstract. A systematic review of incorrect surgery and invasive procedure root cause analyses from the Veterans Health Administration’s safety reporting system revealed three important and recurring attributes: (1) these events often occur outside an operating room; (2) frequently involve a wrong implant; (3) or wrong surgical site level. Fifty-two “time-out” videos on the internet over the years 2010–2015 were reviewed to determine if these key characteristics were demonstrated or discussed. Of the reviewed videos only one (1.9%) incorporated all of the aforementioned attributes while twenty-one (40.4%) failed to address any of the critical components. Internet time-out videos fail to portray the important characteristics of incorrect surgery or invasive procedure, a finding which is unlikely to help further reduce such adverse events. In the future, patient safety educators will need to adjust their screenplays, expand their curricula, or entertain new learner formats to highlight the context and cause of today’s incorrect procedures. Keywords: Patient safety
Time-out
Universal protocol
Wrong-site surgery

1 Introduction Incorrect surgery and invasive procedures include procedures that occur on the wrong patient, wrong side, wrong site (e.g., wrong finger on correct hand), at the wrong level (e.g., wrong spine level), use the wrong implant, or represent a wrong procedure on the correct patient. Although rare, with a reported incidence as low as 1 in 112,994 cases, such incorrect invasive procedures have potentially disastrous consequences for patients, staff, and healthcare organizations [1]. Patients suffer preventable harm, staff may be censured and emotionally traumatized, and healthcare organizations, in addition to the financial exposure, experience a loss of reputation and an erosion of the public’s trust. In an effort to prevent incorrect invasive procedures, The Joint Commission, in July of 2004, mandated the Universal Protocol for teams to follow prior to performing an invasive procedure [1, 2]. The Universal Protocol includes the pre-procedure verification © Springer International Publishing AG (outside the USA) 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_49

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of patient identification and the procedure to be performed; confirmation of proper informed consent; marking of the procedure site; and performance of a time-out [1, 2]. A comprehensive strategy for implementation of high quality time-outs prior to invasive procedures throughout an entire healthcare organization includes education, training, and practice [1, 3, 4]. Many healthcare organizations have posted videos of time-outs on the internet. Video offers unique educational properties for teaching patient safety including capturing “the rich context surrounding care activities, such as tools, equipment, and team interactions” and provides an easy vehicle for meeting the known need for recurrent training identified in the literature [5, 6]. Well-crafted scenarios can show both good and bad examples to help learners see clear distinctions of desired behaviors. However, time-out videos on the internet often fail to address the three recurring attributes of incorrect surgery and invasive procedures identified from the 313 consecutive cases reviewed from 2001–2009 in the VA National Center for Patient Safety (NCPS) Root Cause Analysis (RCA) database: (1) incorrect invasive procedures outside the operating room; (2) wrong implants; and (3) wrong level procedures [7, 8]. In order to prove/disprove our hypothesis, we reviewed 52 time-out videos posted on the internet between 2010–2015.

2 Methods The VA National Center of Patient Safety (NCPS) has extensive experience with the reporting, investigation, and sharing lessons learned regarding incorrect surgery and invasive procedures as well as in the development of policy, procedures, and training to prevent such adverse events. Over the years 2001–2009 the root causes of 313 such adverse events have been extensively studied and published [7, 8]. Three important characteristics of incorrect surgery and invasive procedures include: their occurrence outside the operating room in many instances; wrong implants; and wrong level procedures. We conducted a keyword search of YouTube using the search terms “time out,” “universal protocol,” “time out universal protocol,” and “hospital time out.” A preliminary review excluded unrelated videos. Relevant videos were further restricted to those uploaded between the years 2010 and 2015. Based on these criteria, 52 videos were identified and reviewed in full. These videos were evaluated using a rubric to identify if the aforementioned three attributes of incorrect surgery and invasive procedures were demonstrated or discussed. Any mention of these elements was considered “present” for the purposes of this study.

3 Results The three important attributes of time-outs contributing to incorrect surgery and invasive procedures searched for on videos are shown in Table 1, and their presence or absence demonstrated in Fig. 1. Table 2 (supplemental material) shows all of the films reviewed. Additionally, when evaluating each video for the three critical features of the

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Table 1. Important attributes of time-outs and incorrect surgery and invasive procedures Characteristic (1) Incorrect invasive procedures outside the operating room (2) Wrong implants

(3) Wrong level procedures

Teaching Point 49.1% (104/212) incorrect surgery or invasive procedures occur outside of the operating room Wrong implants comprise 16% (16/101) of incorrect surgery or invasive procedure adverse events. Ophthalmology accounts for 13 of 16 (81%) of these adverse events. Highest rates of incorrect surgery and invasive procedures in neurosurgery, primarily wrong level cases, with incidence of 1.56 per 10,000 cases compared to all specialty rate of 0.4 per 10,000 cases

References [7]

[8]

[8]

60

Number of Videos

50 40

[29] [44]

30

[47]

No Yes

20 [23]

10

[8]

[5]

0 Wrong Implant

Outside OR

Wrong Level

Fig. 1. Observations from 52 time-out videos (2010–2015). To be considered a “yes” the film could merely mention the characteristic (e.g. the word “implant” on a checklist)

time-out process, twenty-one videos (40.4%) included zero, twenty-seven videos (51.9%) covered one, three videos (5.8%) addressed two, and only one video (1.9%) demonstrated all three features.

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4 Discussion Incorrect surgery and invasive procedures are a vexing source of serious preventable adverse events in healthcare with negative consequences for patients, providers, and organizations. The universal protocol including the time-out is a critical countermeasure in the prevention of incorrect surgery and invasive procedures [1]. Education of staff is a key implementation step and certainly time-out video demonstrations have largely played a positive role. Videos have been an excellent medium for demonstrating time-outs and providing recurrent training to the sizable number of caregivers involved with surgery and invasive procedures. We hypothesized that videos posted on the internet currently would fail to cover critical features of an incorrect surgery or invasive procedure; namely, (1) incorrect invasive procedures outside the operating room; (2) wrong implants; and (3) wrong level procedures. These characteristics have surfaced repeatedly in our root cause analysis (RCA) data file and the accompanying lessons learned process in which such organizational learning is fed back to the front line caregivers [9]. In order to prevent recurrent incorrect surgery or invasive procedures, these topics require highlighting and discussion. Incorrect procedures outside the operating room and wrong level procedures were particularly not well-covered. Among the time-out videos reviewed, only one (1.9%) included all three characteristics. Patient safety educators are left with a number of alternatives to ensure that all providers understand the current status of incorrect surgery and invasive procedures. Choices include incorporating basic videos into a larger curriculum or developing more comprehensive videos that address out of operating room and wrong level procedures. The VA and other healthcare organizations have covered all of these elements in training videos [10, 11]. Other options which have proven successful in either improving time-out self-confidence and/or observed performance include high-fidelity simulation and virtual patient simulation [12, 13]. The latter medium is capable of reaching large numbers of providers in a short period of time and can be easily adopted for recurrent training needs much like videos but offer additional educational benefits such as interactivity and feedback [10].

5 Conclusion Despite the advantages of video in teaching patient safety behaviors, this study shows that most on-line time-out videos fail to demonstrate or acknowledge some of the most important aspects of time-outs and the prevention of incorrect surgery and invasive procedures. Patient safety educators can improve these findings by surrounding a basic video with a larger curriculum; creating more comprehensive videos that purposely cover important facets; or by turning to other learning formats such as virtual patient simulation. Acknowledgements. This material is based upon work supported by the Department of Veterans Affairs, the Veterans Health Administration, and the National Center for Patient Safety. The contents of this article are those of the authors and do not necessarily represent the views of

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the Department of Veterans Affairs or the United States Government. Work supported by Grant # DM150022 from the U.S. Army Medical Research and Material Command (USAMRMC), Fort Detrick, MD.

Appendix: Supplemental Material Table 2. Time-out videos reviewed. Organization Lincoln Hospital

Date 2/19/2010

MPMC FBC

3/18/2010

National Patient Safety Agency

5/25/2010

Martin Memorial Hospital

11/23/2010

Dr. Saaty

1/10/2011

South Carolina Hospital Association

2/8/2011

Martin Memorial Hospital

3/1/2011

Martin Memorial Hospital

3/1/2011

Martin Memorial Hospital

3/1/2011

Harvard School of Public Health

3/18/2011

Medical University of South Carolina

5/4/2011

Medical University of South Carolina

5/4/2011

Passavant Area Hospital

6/14/2011

SA Health Australia

6/21/2011

SSM Health - St. Louis

6/24/2011

All Saints Hospital - Racine, Wisconsin

8/31/2011

Palmetto Health

9/1/2011

Link https://www.youtube.com/watch? v=LHbxF3P-DwY https://www.youtube.com/watch? v=kDsuEsWtQXI https://www.youtube.com/watch? v=U6p5LEG04Mu https://www.youtube.com/watch? v=HfB9yA2FdXM https://www.youtube.com/watch? v=gRvD2-10ztY https://www.youtube.com/watch? v=5_7hxJTiua4 https://www.youtube.com/watch? v=7IpFhu7VjdY https://www.youtube.com/watch? v=fQWQPQAsCeQ https://www.youtube.com/watch? v=sSlcXlSx_OA https://www.youtube.com/watch? v=wgqIkhkXYMQ https://www.youtube.com/watch? v=U327eltY5jc https://www.youtube.com/watch? v=lEzwBvByIiE https://www.youtube.com/watch? v=fFJGNob7Kss https://www.youtube.com/watch? v=mUaUoYpc6HI https://www.youtube.com/watch? v=VeE3qiSrGhk https://www.youtube.com/watch? v=BPPCzo4k5QY https://www.youtube.com/watch? v=d6U5pQu6b_c (continued)

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Organization Palmetto Health

Date 9/1/2011

UCSF Department of Neurological Surgery Dartmouth Hitchcock

5/1/2012

University of Louisville Hospital

6/13/2012

UNC Health Care

6/14/2012

Lawrence & Memorial Hospital

7/18/2012

Yekatit 12 Hospital Medical College – Addis Ababa, Ethiopia NYC Health & Hospitals

9/12/2012

Children’s Medical Center – Dallas, TX

11/9/2012

Children’s Medical Center – Dallas, TX

11/9/2012

Connecticut’s Children’s Medical Center Vassar Brothers Medical Center

2/11/2013

Baptist Health System

4/8/2013

Park Nicollet Methodist Hospital

5/13/2013

UCSF

7/12/2013

ACT Government Health

10/22/2013

Hamad Medical Corporation

11/18/2013

Stanford Hospital and Clinics

12/12/2013

Stanford University

2/17/2014

Health Quality & Safety Commission New Zealand Health Quality & Safety Commission New Zealand

2/26/2014

5/23/2012

10/1/2012

2/21/2013

2/26/2014

Link https://www.youtube.com/watch? v=BBQhUucuJsA https://www.youtube.com/watch? v=IYly_CfpkxE https://www.youtube.com/watch? v=IHWQPVY54pA https://www.youtube.com/watch? v=b1J2RiMWVYM https://www.youtube.com/watch? v=HVBQCEC9wT4 https://www.youtube.com/watch? v=QLUA1dj2Pto https://www.youtube.com/watch? v=pFG9ihbPT-A https://www.youtube.com/watch? v=T60gjV6z95c https://www.youtube.com/watch? v=RTJFL8gCayM https://www.youtube.com/watch? v=vS4s9n9jIUY https://www.youtube.com/watch? v=TEZLCwmDUCY https://www.youtube.com/watch? v=9-TmEx4W9MA https://www.youtube.com/watch? v=gtOtUC7XtBc https://www.youtube.com/watch? v=Nbmlp-8xaVc https://www.youtube.com/watch? v=o_HiVoGNY78 https://www.youtube.com/watch? v=BaMjRhoZ7kw https://www.youtube.com/watch? v=mDBG2Bxi0Kg https://www.youtube.com/watch? v=mCFLjxzW5_o https://www.youtube.com/watch? v=2Hg8-WM6tao https://www.youtube.com/watch? v=UoYOdmDX4rA https://www.youtube.com/watch? v=Ywjy3UWhcgM (continued)

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Table 2. (continued) Organization United Memorial Medical Center

Date 3/6/2014

United Memorial Medical Center

3/6/2014

St. Jude Medical Center

5/8/2014

Worcestershire Acute Hospitals NHS Trust National Institute for Health Research (NIHR) Imperial PSTRC Tucson Medical Center

7/16/2014 8/14/2014

Truman Medical Centers

11/7/2014

The Mount Sinai Hospital

1/14/2015

St. Vincent Healthcare

1/26/2015

Dr. Milind Naik, MD

9/11/2015

Elliot Health System

10/3/2015

Elliot Health System

10/3/2015

Elliot Health System

10/3/2015

Henry Ford Allegiance Health

11/2/2015

10/21/2014

Link https://www.youtube.com/watch? v=4X6aNWGqCyE https://www.youtube.com/watch? v=-gO2cV38vZo https://www.youtube.com/watch? v=VQahsC6PW7Q https://www.youtube.com/watch? v=BhWwgXnE7Cc https://www.youtube.com/watch? v=fgBXqPC0OsQ https://www.youtube.com/watch? v=Z6sJuxnJSIs https://www.youtube.com/watch? v=EqmjIYqs-zw https://www.youtube.com/watch? v=8Z4aIbl2gGI https://www.youtube.com/watch? v=GAmgori_hOU https://www.youtube.com/watch? v=uWLPeiWnA-s https://www.youtube.com/watch? v=gTvOUt4cSnU https://www.youtube.com/watch? v=qntNTIgUpBA https://www.youtube.com/watch? v=5aSCa6DYZ0M https://www.youtube.com/watch? v=zVMhLf16eiQ

References 1. Dillon, K.A.: Time out: an analysis. AORN 88, 437–442 (2008) 2. Norton, E.: Implementing the universal protocol hospital-wide. AORN J. 85(6), 1187–1197 (2007) 3. Gottumukkala, R., Street, M., Fitzpatrick, M., Tatineny, P., Duncan, J.R.: Improving team performance during pre-procedure time-out in pediatric interventional radiology. Jt. Comm. J. Qual. Patient Saf. 38, 387–394 (2012) 4. Kelly, J.J., Farley, H., O’Cain, C., Broida, R.I., Klauer, K., Fuller, D.C., Meisl, H., Phelan, M.P., Thallner, E., Pines, J.M.: A survey of the use of time-out protocols in emergency medicine. Jt. Comm. J. Qual. Patient Saf. 37, 285–288 (2011) 5. Xiao, Y., Mackenzie, C.F., Seagull, F.J.: Video to improve patient safety: clinical and educational uses. Agency for Healthcare Research and Quality Patient Safety Network (2015). https://psnet.ahrq.gov/perspectives/perspective/177

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6. Sculli, G., Paull, D.E.: Building a High-Reliability Organization: A Toolkit for Success, pp. 167–175. HCPro, Brentwood (2015) 7. Neily, J., Mills, P.D., Eldridge, N., Dunn, E.J., Samples, C., Turner, J.R., Revere, A., DePalma, R.G., Bagian, J.P.: Incorrect surgical procedures within and outside of the operating room. Arch. Surg. 144, 1028–1034 (2009) 8. Neily, J., Mills, P.D., Eldridge, N., Carney, B.T., Pfeffer, D., Turner, J.R., Revere, A., DePalma, R.R., Bagian, J.P.: Incorrect surgical procedures within and outside of the operating room: a follow-up report. Arch. Surg. 146(11), 1235–1239 (2011) 9. Neily, J., Mills, P.D., Paull, D.E., Mazzia, L.M., Turner, J.R., Hemphill, R.R., Gunnar, W.: Sharing lessons learned to prevent incorrect surgery. Am. Surg. 11, 1276–1280 (2012) 10. Veterans Administration: Ensuring Correct Surgery and Invasive Procedures Video (2016). http://bcove.me/gbbbvf5e 11. St. Jude Medical Center: Procedure time-out training (2014). https://www.youtube.com/ watch?v=VQahsC6PW7Q 12. Paull, D.E., Okuda, Y., Nudell, T., Mazzia, L.M., DeLeeuw, L., Mitchell, C., Lee, C.Z., Gunnar, W.: Preventing wrong-side invasive procedures outside the operating room: a thoracentesis simulation case scenario. Simul. Healthc. 8, 52–60 (2013) 13. Paull, D.E., Williams, L., Sine, D.: High-fidelity versus virtual patient simulation for teaching time-outs prior to invasive procedures: a controlled trial. Patient Saf. Qual. Healthc. 13, 28–37 (2016)

Human Factors in Medical Devices Design

Teaching Proactive Risk Assessment to Clinicians and Administrators Tandi Bagian and Helen J.A. Fuller(&) National Center for Patient Safety, Ann Arbor, MI, USA {Tandi.Bagian,Helen.Fuller}@va.gov

Abstract. The Department of Veterans Affairs (VA) National Center for Patient Safety (NCPS) is charged with developing and implementing the Veterans Health Administration’s (VHA) patient safety programs. This includes teaching human factors and risk assessment methods such as Healthcare Failure Mode and Effect Analysis (HFMEA™) to clinicians and administrators at over 150 facilities. The method for teaching proactive risk assessment described here uses a non-clinical example that encourages participant engagement and permits hands-on demonstration. In the present study, 32 clinicians, administrators, and other VHA staff completed the steps to conduct a proactive risk assessment on the topic of making s’mores over a campfire. An important finding was that the task analysis and review of all relevant risks and preventions was far more robust when the results from individual participants were aggregated. This suggests the value of a collaborative approach to conducting risk assessment within a health care system. Keywords: Patient safety
Human factors Healthcare Failure Mode and Effects Analysis




Proactive risk assessment




1 Introduction The Department of Veterans Affairs (VA) National Center for Patient Safety (NCPS) was founded in 1999 to develop and implement the Veterans Health Administration’s (VHA) patient safety programs. Among other activities, NCPS promotes the use of systems thinking and human factors engineering to address patient safety concerns. The importance of systems thinking in health care became more widely recognized following the publication of the Institute of Medicine (IOM) report To Err is Human: Building a Safer Health System, which called attention to the magnitude of the number and cost of these errors as well as addressing common misconceptions about how they occur [1]. Some methods of addressing patient safety concerns were adapted from traditional engineering tools such as Root Cause Analysis (RCA) and Failure Mode and Effect Analysis (FMEA). Healthcare Failure Mode and Effect Analysis (HFMEA™), derived from FMEA, is a five-step hybrid prospective risk analysis system that uses an interdisciplinary team to proactively evaluate a health care process [2]. The present work focuses on the third step of HFMEA™, process flow diagramming, in which the team members describe the process they are considering, including all subprocesses. © Springer International Publishing AG (outside the USA) 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_50

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Humans rely on their ability to perceive, evaluate, and act to be successful as part of a system [3]. As health care systems become increasingly complex, it is important for colleagues to share the risks that they personally know of or have experienced, so others can be aware and act to avoid failure. For NCPS, failure occurs when the care we provide causes harm to the patient. NCPS teaches human factors and risk assessment methods to clinicians and administrators at over 150 VA Medical Centers (VAMCs). NCPS representatives have experimented with different techniques for presenting engineering tools in ways that facilitate learning among participants without engineering backgrounds [4]. The method for teaching proactive risk assessment described here uses a non-clinical example that encourages participant engagement and reinforces to learners the value of HFMEA™ to identify opportunities for system improvements that may assist in avoiding adverse outcomes.

2 Methods NCPS conducts an introductory patient safety course periodically for new VHA patient safety staff. During one of these training sessions, 32 participants completed a proactive risk assessment activity similar to HFMEA™. Most participants had a clinical background, and most were currently working in an administrative role covering patient safety at a VAMC. Participants were told they would be completing a proactive risk assessment on making s’mores, a classic camping treat made by toasting marshmallows over a fire and then sandwiching them, along with a bar of chocolate, between two graham crackers (Fig. 1).

Fig. 1. The components of a s’more (left) and the assembled final product (right).

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Under direction from a moderator, participants completed the form shown in Fig. 2. The main task categories were specified: get fire ready, get equipment ready, make s’more, and clean up. For each category, participants were instructed to add as many steps or subtasks as they could think of.

Fig. 2. Participants completed this task analysis page. Tasks were provided, as shown, and participants filled in corresponding subtasks.

Participants also were asked to identify the subtask they were most worried about and to list causes of that worry. Participants listed causes, identified the cause that they thought was most likely or most serious, and then listed what actions they believed would eliminate or minimize that cause. The result is a list of worries, or potential failure modes, to be considered for each step of the procedure as well as a list of potential actions that could be taken to minimize risk of those failure modes. To analyze the results, the authors reviewed each participant’s paper and entered all subtasks in a spreadsheet. The authors then grouped subtasks that seemed substantially similar and calculated the total number of participants who had identified each subtask. Finally, the authors calculated the total subtasks under each task for each participant.

3 Results No participant successfully identified all the critical subtasks. Participants were more likely to identify the more readily available steps that, if skipped, would result in failure to complete the goal. For example, nearly all participants listed “light fire” and some form of assembling the graham cracker, chocolate, and marshmallow into a sandwich as subtasks. Subtasks and the number of participants who identified each are shown in Table 1.

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Table 1. Subtasks that participants identified for each of the following tasks are shown. The number after each subtask is the number of participants who listed some form of this subtask. Task 1: Get fire ready

Task 2: Get equipment ready

Task 3: Make s’more Task 4: Clean up

Plan (1)

Make list of ingredients (1)

Pull hair back (1)

Check open fire permits (1)

Go to grocery store (1)

Light fire (2)

Have safety equipment ready (water, shovel) (10)

Get shopping cart (1)

Set ingredients and equipment on table (1) Set plate out (1)

Obtain fire pit, find safe location Check out from store (1) for fire pit (away from low-hanging limbs, trees, brush) (17) Find stones (2) Take supplies to campsite (1) Place rocks or bricks in a circle, Set up pile with material (1) build barrier in dirt area, assemble fire ring, dig small pit (4) Clear fire pit of debris, clear/wet Get utensil for marshmallows area around pit, keep away from (long sticks, roasting sticks, hanger, rotating skewer, etc.) trees (4) (27) Get (dry) fuel (charcoal, wood, Clean forks (1) sticks) (28) Cut the fire wood (1)

Select sharp knife (1)

Collect dry grass, get kindling, brush, paper, leaves (19)

De-branch stick or untwist hanger, carve ends of stick to points, sharpen stick (4)

Crumple paper (2)

Lay roasting stick aside (1)

Stack/arrange wood, kindling, paper, build fire (17) Keep logs and matches dry (1)

Give sticks to adults (1)

Get ignition source (matches, lighter, flint) (21)

Tear off aluminum foil in 8″ strips (1) Pour water in bowl for wiping hands during process (1)

Get/open graham crackers (5)

Break graham crackers, get two squares (6) Place graham cracker half on plate/napkin (3) Open chocolate container and remove one, get chocolate (3) Unwrap (paper and foil) from chocolate bars (2)

Break chocolate bar in half (4) Discuss with kids how to avoid Place chocolate on poking in eyes (1) cracker (15) Make sure matches or lighter Wrap work (1) chocolate + cracker in foil and take to where fire is (1)

Have water available for cleanup and fire (2) Burn marshmallow sticks, throw hangers away (4) Clean utensils, clean stick (using fire, water, napkin) (8) Watch fire burn (1)

Extinguish fire (with water) or sit and enjoy until out (29) Mix ashes and embers with dirt and stir in water, use shovel to mix until no smoke is seen (being careful not to burn yourself) (7) Feel embers and wood to make sure they are cool to the touch (1) Add more water to ashes/embers (3) Scan area for possible sparks/embers, make sure fire is completely out before leaving the area (2) Clean fire pit, bury fire site (2)

Pack supplies, clean up equipment and paper products, gather supplies onto tray, clean up all materials (7) Wrap up leftovers and put away (15) Hang plastic bags in trees away from animals (1) Throw trash, plate, napkins away, recycle foil (20)

(continued)

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Table 1. (continued) Task 1: Get fire ready

Task 2: Get equipment ready

Get lighter fluid, flame starter, fire starter (8)

Gather ingredients, locate equipment (2)

Get gas tank (1)

Pour lighter fluid (3)

Light/strike match (3)

Light/start fire (25)

Blow on flame (2)

Poke fire (1)

Guard fire from wind (1)

Task 3: Make s’more Task 4: Clean up

Put chocolate + cracker on table (1) Get (Jumbo/big) marshmallows Hand each (27) participant a hanger and have them straighten it (1) Get graham crackers (27) Open bag of marshmallows and remove two, take marshmallow out of bag (3) Get chocolate (bars, Hershey) Put marshmallow on (27) stick/prong/skewer (20) Trash can/bag (4) One eye on kids, one eye on marshmallow (1) Fire wood (2) Find out if people need help roasting (1) Rock (1) (Safely) grill/toast/heat marshmallows (30) Kindling (moss, small sticks, Rotate stick to ensure dry leaves) (2) even toasting (1)

Watch fire (1)

Have matches, flint, and/or lighter (3)

Tend fire, add wood, build up fire (9) Wait for fire to burn down (2)

Strike match (1) Light fire (3)

Put chairs around fire (2)

Fan fire (1)

Lick fingers (1)

Wash hands (10)

Clean mouths/face (5)

Turn water to hose off (1)

Put chairs away (5)

Store matches/lighter in safe place (2) Store lighter fluid safely (1)

Put sharp objects (marshmallow forks) away (2) Pick up trash on ground, clean up area (3)

Marshmallow bubbles or catches fire, put marshmallow out (2) Burn (some) Put trash bag in receptacle, marshmallows (2) take all trash with you (3) Remove Take supplies inside (1) marshmallow from heat, remove before burning, stop if charring or on fire (4) Heat chocolate (1)

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Task 1: Get fire ready

Task 2: Get equipment ready

Announce fire is ready (1)

Tend fire (add more kindling or Safely/carefully wood as needed) (1) remove marshmallow (8)

Discuss fire safety (3)

Tray (1)

Sit and enjoy fire (1)

Get stick for marshmallows (2)

Get marshmallows (1)

Task 3: Make s’more Task 4: Clean up

Be careful not to touch hanger when removing marshmallow (1) Get (paper) plates (12) Put (cooked) marshmallow on top of chocolate, between graham crackers (20) Get wet naps/napkins (12) Check kids for burn injuries and eyes intact (1) Get aluminum foil (1) Allow marshmallow to cool enough to not burn tongue, be careful if hot (3) Get chairs for around fire pit Distribute s’mores (5) (1) Get table or flat surface (2) Squeeze together until gooey goodness oozes out/smash together (2) Get fire extinguisher (3) Eat and enjoy (15) Get garden spade (1) Repeat as desired (2) Get water, make sure you have Throw plate in fire enough water for cleanup and (1) putting fire out (3) Make sure you have a pan for cleanup (1) Sanitizer for hands (1) Have utensils ready if needed (1) Get citronella candles (2) Get oven mitts, just in case (1) Open packages and get ingredients out (2) Prepare food: arrange chocolate and graham crackers for individual portions, layer chocolate bars on graham crackers, break graham cracker and chocolate and assemble on plate, place crackers on plate and break chocolate into 100 squares (4) Put marshmallow on stick (1) Have people to enjoy with (1)

Go to bed after your sugar crash (1)

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Participants were less likely to identify peripheral tasks that might cause problems but would not directly interfere with the completion of the main goal (“make s’more”). For example, only a few participants identified fire safety concerns such as clearing brush from around the fire pit and supervising children around the fire. Similarly, participants were much more likely to identify the equipment directly involved in achieving the goal than equipment needed to prevent adverse outcomes. For example, 27 participants identified “marshmallow,” “chocolate,” and “graham crackers” as necessary equipment, but only six listed “fire extinguisher” or “water.” Some participants provided a long list of detailed subtasks while others gave only a few subtasks for each task. The mean, standard deviation, minimum, and maximum number of subtasks are given in Table 2. Table 2. Number of subtasks for each of the four main tasks. Metric Mean (SD) Minimum Maximum

Task 1: Get fire ready 6.3 (2.0)

Task 2: Get equipment ready 6.2 (2.2)

Task 3: Make s’more 5.8 (3.0)

Task 4: Clean up 4.3 (1.8)

3 10

2 11

1 12

2 9

4 Discussion An important finding was that the task analysis and review of all relevant risks and preventions were much more robust when the results from individual participants were aggregated. This suggests the value of a collaborative approach to conducting proactive risk assessments within a health care system. Collaboration may come both from having a multidisciplinary team and from sharing findings between facilities to learn from those with different institutional experiences. There were notable differences in the level of detail that different participants provided. Some simply listed the main components of a s’more (graham crackers, chocolate, marshmallows) for the “get equipment ready” task. In contrast, others included steps such as “remove chocolate bar from bag,” “remove wrapper,” and “break bar into squares.” Failing to include necessary subtasks limits the scope and thoroughness of the analysis, because hazards associated with those subtasks may not be identified. For example, failing to completely remove the foil covering the chocolate may result in someone ingesting inedible material. Only eight participants explicitly described removing the toasted marshmallow from the stick, though many wrote of putting the marshmallow between the graham crackers. This is a potentially dangerous step that many did not even consider. If the stick used to toast the marshmallow is metal, there is a risk of burn during this step. Some participants appeared to have different expectations than others during this analysis. For example, some assumed that a structure for the fire existed and listed “locate fire pit” as a subtask. Others assumed they needed to construct a place for the fire and had multiple subtasks, including “locate safe place for fire pit,” “clear brush

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away from fire area,” and “stack rocks in a circle.” This illustrates the impact of different and possibly false assumption and the need to clearly state any assumptions while performing a task analysis. Participants sometimes used different words and phrases to express the same ideas. For example, to describe the process of stacking the firewood into an arrangement that would burn properly, some wrote, “stack firewood,” and others gave more detailed descriptions like, “arrange wood and kindling for maximum burn.” Two participants wrote, “build fire,” which could be considered a term of art for strategically arranging firewood. During a task analysis, it is important to write out subtasks using plain language and to avoid assuming expertise on the part of those who will use the task analysis. Participants displayed many different ideas about what equipment to use to roast marshmallows, including hangers, sticks, and long forks. There were corresponding differences in what was needed for preparation (unbend hanger; whittle stick to a point; nothing) and what was needed during clean up (dispose of hangers; burn sticks in remains of fire; burn remnants of marshmallow off fork, soak in water, and wipe clean). One interesting observation from this data set was that one participant listed “tend fire” as a subtask in “get equipment ready.” This implies the participant was thinking of the fire as a piece of equipment for the next step, “make s’mores.” Different interpretations of what is considered equipment may result in differences in the task analysis. There were also significant differences with the amount of detail that participants provided when specifying equipment needs. This was most noticeable with the ingredients for the s’mores. Most participants (27/32) listed the basic ingredients: marshmallows, chocolate and graham crackers. Only a few specified important details such as using jumbo marshmallows (16 grams each) rather than regular marshmallows (7.5 grams each) or a bar of chocolate rather than chocolate chips. Participants displayed a large amount of variability in the order of subtasks. This could be partially an artifact of the training session, because participants were brainstorming in real time and did not have the ability to make revisions. Future studies might look at the impact of allowing participants to develop more formal task analyses to see if this variability remains. While the process of making s’mores is not directly relevant to safe patient care, selecting this widely known process provided the ability for all participants to discuss and understand the limitations of proactive risk assessment. The lessons learned from the group included insight into how varied their individual experiences are. The assumptions regarding the task, environment, and humans performing the process may be vastly different for each participant. Just as some of the participants expected to create a fire pit while others envisioned a campsite that already included a fire pit, the individuals on a team slated to perform a procedure in a given environment need to understand that not all items in a task analysis necessarily relate to their situation. Aggregating the larger set of issues each individual person could envision, based on their experiences, allowed a robust discussion, which could naturally lead to generation of a checklist of issues. The HFMEA™ process would then allow the team to formalize these as failure modes and mitigating actions to consider prior to actually performing the task.

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Training activities such as this proactive risk assessment may help participants develop a “preoccupation with failure,” which is a characteristic of high reliability organization [5, 6]. In addition, it demonstrates for learners the value of techniques such as HFMEA™, making it more likely that they will engage as active participants on such activities at their own facilities.

References 1. Donaldson, M.S., Corrigan, J.M., Kohn, L.T. (eds.): To Err is Human: Building a Safer Health System, vol. 6. National Academies Press, Washington (2000) 2. DeRosier, J., Stalhandske, E., Bagian, J.P., Nudell, T.: Using health care failure mode and effect analysis™: the VA National Center for Patient Safety’s prospective risk analysis system. Joint Comm. J. Qual. Improv. 28(5), 248–267 (2002) 3. Wickens, C.D., Kessel, C.: The processing resource demands of failure detection in dynamic systems (No. EPL-79-1/AFOSR-79-1). Illinois Univ at Urbana Engineering-Psychology Research Lab (1979) 4. Miller, K., Bagian, T., Williams, L.: Human factoring healthcare: making human factors more accessible. In: Proceedings of the International Symposium on Human Factors and Ergonomics in Health Care, Sage India, New Delhi, India, vol. 3, no. 1, pp. 191–195. SAGE Publications (2014) 5. Weick, K.E., Sutcliffe, K.M.: Managing the Unexpected: Resilient Performance in an Age of Uncertainty, vol. 8. Wiley, Hoboken (2011) 6. Sculli, G.L., Paull, D.E.: Building a High-Reliability Organization: A Toolkit for Success. HCPro, Marblehead (2015)

Potential and Influence of Industrie 4.0 in Oral Implantology Products and Their Production for Patient, Dentist and Dental Laboratory Yübo Wang1 ✉ , Oliver Sandig2, Christian Steinmetz1, Christof Ellerbrock2, and Reiner Anderl1 (

1

)

Technische Universität Darmstadt, Otto-Berndt-Str. 2, 64287 Darmstadt, Germany {y.wang,steinmetz,anderl}@dik.tu-darmstadt.de 2 C3System GmbH, Elisabethenstr. 20–22, 64283 Darmstadt, Germany {o.sandig,c.ellerbrock}@c3system-gmbh.de

Abstract. The purpose of this paper is to identify on the one hand the influence of Industrie 4.0 to the horizontal value creation in the process chain patient-dentist and the process chain dentist-dental laboratory. On the other hand, the effect of Industrie 4.0 to the vertical value creation in the manufacturing process chain of implants, abutments and crowns in a dental laboratory are explained. In addition, the potential of the Industrie 4.0 in CAx-pre-processing and post-processing of each process chain is presented. Furthermore, the Human-Machine-Interaction in the modeling of oral implantology products and their individual medical service functional upgrade to a Smart Health Product is discussed [1]. Based on these results, new business models between the correlation patient, dentist and dental laboratory are generated. Keywords: Industrie 4.0 · Dental technology · Oral implantology

1

Introduction

Industrie 4.0 has a successful introduction with Smart Product, Smart Production or Smart Health to many industries. It provides new impulses for the development and application of cyber-physical systems on the way to the Internet of Things, Services and Data. Through networking and communicating systems, a new level of organization and management of the value chain can be achieved. New business models will be generated. Dental technology looks back on a long tradition of handmade products, namely dentures, because the products have to be adapted for different patients, each equipped with individual geometries and functional requirements, hence the dental products must be individual. In general, development and manufacture of individual products requires new concepts and approaches because traditional shop-floor production is not suitable for the creation of individual products. In the last years, Industrie 4.0, the term for the fourth industrial revolution, provides new impulses for the development and application in many industries, such as Smart Products, Smart Production or Smart Health. To iden‐ tify the benefits and innovative technologies, which can be enabled by fourth industrial © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_51

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revolution, the method “Industrie 4.0 Toolbox” provides a comfortable way of analyzing current production and creating visions [2].

2

State of the Art of Dental Products and Production

The collaborative research project COMMANDD (computer-aided design and manu‐ facture of dental products) deals with the digital process chain of dental technology and focuses on hybrid manufacturing technologies, process chain validation and dental data management (Fig. 1). A special feature of the digital dental process chain proposed in COMMANDD is the customer-specific mass production. COMMANDD supports the vision of an integrated development of dental products and integrated workflow plan‐ ning. For the first time a continuous workflow could be provided between dentist, dental laboratory and milling center. As further results, media breaks are avoided and sources of errors are decreased [3].

Fig. 1. Federative dental data management [3]

The fundamentals of integrated workflow planning are the federative dental data management (FDDM) systems as virtual integration platforms. Each stakeholder (dental office, dental laboratory, milling center) has to manage the digital dental workflow by using a domain-specific FDDM system. Depending on workflow specific collaboration

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constellations, data can be transferred between the FDDM systems over the internet. The proposed concept provides a contribution to fulfill the paradigm of a patient indi‐ vidual production aiming at a price of mass production by enhancing process relia‐ bility [3]. The research project EVIPRODENT (experienceable virtuality for the dental product development) deals with the development of digital dental technology for the design of complex dentures in a direct, all-digital process chain by means of the approach of making the product development experienceable. Existing methods for virtual devel‐ opment of dental prostheses are based on an indirect human-machine interaction. Along this indirect process chain increased media breaks evolve. The denture design is char‐ acterized by higher risk of error and a low individualization. Therefore, natural sensa‐ tions, such as the 3-dimensional vision, as well as the benefits of sensorimotor movement patterns based on the craftsmanship are both used to improve virtual product develop‐ ment (Fig. 2). Additionally, both costs and product development times can be reduced at improved quality [4].

Fig. 2. Virtual development of dental prostheses [5]

There are many different methods for the reconstruction and data acquisition of complex 3D models. While mostly mechanical technologies have been used in the past, optical technologies are being increasingly used. These have the advantage of fast and non-contact 3D data acquisition. Optical scan technologies can generally be distin‐ guished into active and passive methods. While active methods selectively apply energy in the form of light to the object and detect and analyze the reflected or transmitted energy, passive methods only use the existing radiation of the object for 3D reconstruc‐ tion. For the 3D reconstruction in the dental field, mostly active scan technologies are used because they are more robust, efficient and accurate [6].

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Industrial 3D dental scanners can be divided into two categories: intra- and extraoral dental scanners. While intraoral scanners are used by dentists in dental offices (Chair‐ side), extraoral scanners are used by dental technicians in dental labs (Labside). Intraoral scanners (Fig. 3) digitize parts of the oral cavity directly in patient’s mouth without having to create an impression. However, some intraoral scanners require powdering or other treatment of the desired scan area. All intraoral scanners use optical measurement technologies. Extraoral scanners, on the other hand, digitize a physical impression of the oral cavity situation produced by the dentist [7].

Fig. 3. Intraoral 3D scanning systems with different scan technologies [8].

A benchmark using the standards DIN EN ISO 12836:2013-01 or ISO 12836:2012 can be used to compare the technologies and scanners. Alternatively, the scanner capa‐ bility detection component specially developed for anatomical structures at TU Darm‐ stadt can be used [7]. The accuracy of dental scanners differs extremely between scanning technologies as well as from study to study and manufacturer specifications. Manufacturer specifications for accuracies commonly range from about 5 μm to 20 μm for extra-oral [9, 10], and from about 11 μm to 30 μm for intraoral [9] scanners. In vitro studies (controlled envi‐ ronment outside of a living organism) on the other hand measured accuracies from about 29 μm to 46 μm for extra-oral [10], and from about 15 μm to 82 μm respectively 40 μm to 50 μm for intraoral [8, 11] scanners. The reason for the difference in the accuracy is mainly in the movement of the camera in the operator’s hand during simulation of the process of intraoral digitization [12]. In order to analyze current Industrie 4.0 capability to existing products and produc‐ tion environments, as well as the identification of future trends for improving products and production, the Toolbox Industrie 4.0 uses two tables, see Figs. 4 and 6. For each row, the current state of products as well as production is analyzed and marked in the table by drawing a circle in the estimated column. The interconnection between the rows is a measure for the capability for Industrie 4.0. The states on the right side of the mark in each row indicates potentials for future trends. These abstract descriptions of the future trends must be adapted to the meaning of the analyzed product and production.

3

Application of Industrie 4.0 Toolboxes

Methodically the Industrie 4.0 Toolbox Product, Industrie 4.0 Toolbox Production and Industrie 4.0 Toolbox Engineering is used to reflect the present condition of an oral

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implantological product and its manufacturing. The Toolboxes are structured in appli‐ cation level vertically and development stage horizontally. Application levels establish Industrie 4.0 themes. Every application level is broken down in five technological and sequential stages. The highest level represents the vision Industrie 4.0. Based on the present condition, reflection profiles ideas of process optimization and new business models are generated. The toolboxes display the application level vertically and development stage hori‐ zontally. Industrie 4.0 themes are shown in the application level and every application level is broken down in five technological and sequential stages, where the highest level represents the vision Industrie 4.0. The goal is to achieve an Industrie 4.0 competence overview on current dental product development and production environment. The Toolboxes support generating a competence profile by classifying the development state of every application level for dental product development and production environment. In Figs. 4 and 6, the full lined profile represents the current dental Industrie 4.0 competence of dental product devel‐ opment and production environment. After the accomplishment of the analysis, the potential for optimization in terms of dental Industrie 4.0 is presented in dotted lined profile [2, 13]. 3.1 Analysis for Dental Products The first application level represents the integration of sensors and actuators, where the development stage starts with the product having no use of sensors and actuators and the Industrie 4.0 vision is that the product responds independently based on gained data. Current dental products like crown, bridges, abutments or implants have no integration of sensors and actuators. The integration of chemical, pressure, communication or thermic sensors build a fundament for the functional use of the dental product. The second application level represents the communication and connectivity, where the development stage starts with the product having no interfaces and the Industrie 4.0 vision is that the product having access to the internet. Current dental products like crown, bridges, abutments or implants have no communication and connectivity. The integrated sensors, described in the first application level, provides data that can be transmitted by communication and connectivity devices. The third application level represents the functionalities for data storage and exchange of information, where the development stage starts with the product having no functionalities and the Industrie 4.0 vision is that the data and information exchange as integral part of the product. Current dental products like crown, bridges, abutments or implants have no functionalities for data storage and exchange of information. The integration of rewritable data storage enables restricted information exchange. An advised person like the dentist can retrieve collected information in the patient-dentist process chain. The fourth application level represents the monitoring, where the development stage starts with no monitoring by the product and the Industrie 4.0 vision is the independently adopted control measures of the product. Current dental products like crown, bridges,

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abutments or implants have no monitoring features. Prognosis of its own functional conditions can be established by the integration of monitoring capabilities.

Fig. 4. Full lined/dotted: current/advanced dental Industrie 4.0 competence of the product [2]

The fifth application level represents the product-related IT services, where the development stage starts with no services and the Industrie 4.0 vision is that the complete integration into an infrastructure of IT services. Current dental products like crown, bridges, abutments or implants have no product-related IT services. Services execution

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directly via the dental product supports resilient and trustful health condition in the patient-dentist process chain. The sixth application level represents the business models around the product, where the development stage starts with gaining profits from selling standardized products and the Industrie 4.0 vision is the sale of product functions. New business models by selling the product function extend the traditional patient-dentist relationship in sales and consulting and adaption of the product to meet the customer specifications. The dental product Industrie 4.0 vision is to sell health, beauty or reliability in the patient-dentist environment [2].

Fig. 5. Full lined/dotted: current/advanced dental Industrie 4.0 competence of the product [2]

3.2 Analysis for Dental Production Environment The first application level represents data processing in the production, where the devel‐ opment stage starts with no processing of data and the Industrie 4.0 vision is that the automatic process planning and control. Current dental laboratories use technologies for storing and documentation of patient-dentist data. Every dental application is processed sequentially according to the incoming order. Order optimizations are processed only manually by dental technicians. Automatic process planning and control increases the efficiency and effectiveness of individualized order-related dental product manufac‐ turing. The second application level represents the machine-to-machine-communication, where the development stage starts with no communication and the Industrie 4.0 vision is web services. Current dental laboratories use dental milling machines with industrial ethernet interfaces only for remote maintenance or centralized production control. Using web service technologies for machine-to-machine-communication enables data exchange between every process step member in the dental CAx-process chain and cross enterprise order production exchange. The third application level represents the company-wide networking with the production, where the development stage starts with no networking of production with other business units and the Industrie 4.0 vision is inter-divisional, fully networked IT

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solutions. Current dental laboratory using uniform data formats and rules for data exchange in the dental CAx-process chain. Transparency and increased efficiency and effectiveness is established by interdivisional, fully networked IT solutions.

Fig. 6. Full lined/dotted: current/advanced dental Industrie 4.0 competence of the production [2]

The fourth application level represents the information and communication tech‐ nology infrastructure in production, where the development stage starts with information exchange via mail and telecommunication and the Industrie 4.0 vision is that suppliers

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and customers are fully integrated into the process design. Current dental laboratories use information exchange via email and telecommunication. Automated information exchange like order tracking, purposed in Federative Dental Data Management, supports the integrated development of dental products and integrated workflow planning including a continuously workflow. The fifth application level represent the man-machine interfaces, where the devel‐ opment stage starts with no information exchange between user and machine and the Industrie 4.0 vision is augmented and assisted reality. Current dental laboratories use local user interfaces for human-machine interactions. Augmented and assisted reality enhances the development of digital dental technology for the design of complex dentures in a direct, all-digital process chain by means of the approach of making the product development experienceable. The sixth application level represents the efficiency with small batches, where the development stage starts with rigid production systems and a small proportion of iden‐ tical parts and the Industrie 4.0 vision is component-driven, modular production in valueadding networks [4]. Current dental laboratories consist of rigid production systems and a small proportion of identical parts. In the dental environment, the identical parts are classified as identical processes with batch size one. New business models are estab‐ lished in the dental value-adding network by component-driven, flexible production of modular products within the company [2].

4

Identified Future Work and Summary

The analysis in Sects. 3.1 and 3.2 presents the potential of Industrie 4.0 for dental prod‐ ucts and dental production environments by using current technologies (Figs. 5 and 7). The vision of Industrie 4.0 in every application level could be achieved by basic research and application-oriented implementation. For all application levels of Industrie 4.0 for dental products, the research topics of micro-sizing the sensors and actuators, increasing the efficiency the energy source, effectiveness in data analytics, and standards for data

Fig. 7. Full lined/dotted: current/advanced Dental Industrie 4.0 competence of the production [2]

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and information exchange have to be focused. For all application levels of Industrie 4.0 for dental production environment, the research topics of holistic data management, individualized additive manufacturing, IT security [14], increased precision and accu‐ racy of scanning technology, and functionality mockup of the diversity between Enter‐ prise-Resource-Planning, Product-Data-Management and Manufacturing Execution System. In summary, the challenges of Industrie 4.0 in oral implantology products and their production for patient, dentist and dental laboratory are introduced and analyzed. There‐ fore, the Toolbox Industrie 4.0 Product and the Toolbox Industrie 4.0 Production are consulted for analyzing the current dental product development and production envi‐ ronment. Afterwards, the potential for optimization in terms of dental Industrie 4.0 is presented.

References 1. Kagermann, H., Wahlster, W., Helbig, J.: Recommendations for implementing the strategic initiative INDUSTRIE 4.0. Securing the future of German manufacturing industry, April 2013 2. Anderl, R., Picard, A., Wang, Y., Fleischer, J., Dosch, S., Klee, B., Bauer, J.: Guideline Industrie 4.0 - Guiding principles for the implementation of Industrie 4.0 in small and medium sized businesses, VDMA Forum Industrie 4.0, Frankfurt (2015) 3. Heister, R., Anderl, R.: Concept for an integrated workflow planning of dental products based on federative data management. In: 34th Computers and Information in Engineering Conference, vol. 1A (2014) 4. Steinmetz, C., Christ, A., Heister, R., Grimm, M., Anderl, R., Sandig, O., Ellerbrock, C.: Mediated reality in dental technology. In: 21st European Concurrent Engineering Conference, ECEC 2015, 11th Future Business Technology Conference, FUBUTEC 2015 and 19th Euromedia Conference, EUROMEDIA 2015. EUROSIS-ETI, Lisbon, Portugal, pp. 89–95 (2015) 5. Hosan, J.M.: Photographer on the order of the HA Hessen Agentur GmbH und Tochtergesellschaften. Results from the project “EVIPRODENT”, Recording date: 21 December 2016 6. Gühring, J.: 3D-Erfassung und Objektrekonstruktion mittels Streifenprojektion. Doktorarbeit, Universität Stuttgart, Stuttgart (2002) 7. Heister, R., Christ, A., Arndt, A., Anderl, R.: Method to verify 3D scanners for the prosthetic dentistry. In: 13th CIRP Conference on Computer Aided Tolerancing, CIRP-CAT (2014) 8. van der Meer, W.J., Andriessen, F.S., Wismeijer, D., Ren, Y.: Application of intra-oral dental scanners in the digital workflow of implantology. PLoS ONE 7(8), e43312 (2012). doi: 10.1371/journal.pone.0043312. Epub 22 August 2012 9. Sandig, O.: Entwicklung und Evaluierung von 3-D-Scantechnologie im Dentalbereich. Master Thesis, TU Darmstadt (2014) 10. González de Villaumbrosia, P., et al.: In vitro comparison of the accuracy (trueness and precision) of six extraoral dental scanners with different scanning technologies. J. Prosthet. Dent. 116(4), 543–550.e1 (2016) 11. Ender, A., Mehl, A.: Full arch scans: conventional versus digital impressions-an in vitro study. Int J Comput Dent 14, 11–21 (2011)

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12. Trifkovic, B., Budak, I., Todorovic, A., Vukelic, D., Lazic, V., Puskar, T.: Comparative analysis on measuring performances of dental intraoral and extraoral optical 3D digitization systems. Measurement 47, 45–53 (2014). http://dx.doi.org/10.1016/j.measurement. 2013.08.051.9. ISSN 0263-2241 13. Wang, Y, Wang, G, Anderl, R.: Generic procedure model to introduce Industrie 4.0 in small and medium-sized enterprises. In: Lecture Notes in Engineering and Computer Science: Proceedings of the World Congress on Engineering and Computer Science 2016, 19–21 October 2016, San Francisco, USA, pp. 971–976 (2016). ISBN: 978-988-14048-2-4 14. Wang, Y., Fahkry, R., Rohr, S., Anderl, R.: Combined secure process and data model for ITSecurity in Industrie 4.0. In: Lecture Notes in 25th International Multi Conference of Engineers and Computer Scientists 2017, 15–17 March 2017, Hong Kong, China. ISBN: 978-988-14047-3-2. (Accepted for publication)

Development of Pneumatic Dual-Cell Stacking Implanter Yih-Lin Cheng ✉ and Yi-Tung Lai (

)

National Taiwan University of Science and Technology, Taipei, Taiwan [email protected]

Abstract. Recent studies have found that implanting mixtures of dermal papilla cells and epidermal cells could promote hair follicle regeneration. This approach will provide better opportunity than hair transplantation to treat alopecia. However, there is no suitable implanter to fulfill these functions, yet more consid‐ erations in human factors for the operators. Therefore, this research planned to develop a pneumatic duel-cell implanter that can stack the cells, control the implanting volume, and reduce the burden of doctors’ hand during operation. In order to reduce the weight of the implanter, separated modules were designed, including cell loading control module, handheld injection module, and pneumatic source. The cell loading control module contains two syringes for different cells and a volume control system equipped with liner step motor, delivering the required volume of cells into handheld module. Silicone tubes were used to connect these two modules. Two types of cells can be directed into the handheld injection module and stacked. The handheld injection module mimicked the size and the weight of a ball pen and adjust the mass center for comfortable holding. Near the injection tip, an angle stand was attached to adjust the injection angle for less loading to the hand. The top side of the handheld module was connected to the pneumatic source by flexible pipe. The pneumatic source was triggered by foot stepping to reduce the works by fingers and pushed the cells into scalp. The prototype of the implanter performed simulated implantation test by injecting silicone oil and blue ink into a transparent silicone block. The results showed that the implanter can successfully implant and stack two fluids in the same area. Moreover, suitable air pressure for injection was found and injected volumes were tested. As a result, the handheld injection module only weighs 12 g and no extra loads are needed by hand, which is suitable for implantation operation. Keywords: Implanter · Hair follicle regeneration · Pneumatic

1

Introduction

With the increasing numbers of alopecia, the treatment of has become an important issue. The popular treatment approaches include finasteride, minoxidil, wearing a wig, and hair transplantation. The effects of finasteride and minoxidil are varied by people, and the continuous therapy is required. Since hair transplantation takes the hairs from the patients themselves and no additional hair follicles are generated, it is limited by the amount of healthy hairs left. Due to the development of regenerative medicine these

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years, hair follicle regeneration techniques [1, 2] may provide an alternative to treat alopecia. Recently studies have found that implanting mixtures of dermal papilla (DP) cells and keratinocytes could promote hair follicle neogenesis [3], and more studies are in progress by stacking these two types of cells in order while implanting. There are many hair transplantation tools available [4–6] to handle similar implantation environ‐ ment to the application in this research, but the size and properties of follicular units are different from DP cells and keratinocytes. Other gene guns [7] or implanters [8–11] are not applicable to our duel-cell stacking purpose, either. Moreover, the implantation involves repeating movements to cover the target scalp area; hence, the human factor issues regarding long-period operation and repeating actions should be considered to reduce operators’ discomforts. In this research, a pneumatic duel-cell stacking implanter is developed to provide targeted functions and also incorporate human factors in the design.

2

Design Concept

The implanter needs to achieve the basic function of implant two type of cells in the same location. The injection approach of single needle with stacking cells first in one tube was considered. Compared to duel-needle setup, this method will create smaller wounds on the scalp. Since the implantation for a patient usually takes hundreds or thousands of times in one operation, doctors need to repeat same loading and injection action for a long period of time. Heavy device and repeating pressing by fingers will induce hand injury. Therefore, in this design, human factors became a very important consideration, which cannot be ignored. To reduce the burden of doctor’s hand during operation, the implanter was divided into three separated modules—cell loading control module, handheld injection module, and pneumatic source. Separation of the cell loading control from the main handheld portion will keep the handheld tool light. Silicone tubes are utilized to deliver the cells to the handheld module. The injection was triggered pneumatically by foot stepping, which can reduce the use of fingers. The air inlet is placed at the top end of the handheld module to provide appropriate air pressure to push

Silicone tubes

Syringes

Air inlet

Pneumatic source Cell inlets

Stepping motor

cell loading handheld control module injection module

Fig. 1. The design concept of the implanter.

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the cells out. The design concept of the implanter is shown in Fig. 1. Through this approach, doctors can conduct the operations easily and comfortably.

3

Detailed Design of Implanter Modules

3.1 Cell Loading Control Module The cell loading control module is a separate device from the main handheld module in order to reduce its total weight and to precisely control the cells volume loaded into the injection module. The stepping motor was selected since it can achieve linear positioning without additional components, hence less errors would be introduced. The syringes that contain cells are connected to a moving plate at the same time, and the motor pushes the moving plate forward to certain pre-determined distance for each loading. The cells are loaded into the handheld module through the silicone connecting tubes. The syringes are held by the changeable syringe fixtures (Fig. 2) to fit the need of loading various amount of cells, and the fixtures are mounted to a base platform. The major structural components of the cell loading control module are shown in Fig. 3.

Fig. 2. Syringe fixtures for different size of syringes

(a) Motor fixture

(b) moving plate

(c) syringe holder base platform

(d) changeable syringe fixture

Fig. 3. The major structural components of the cell loading control module (CAD and prototype)

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3.2 Handheld Injection Module The handheld injection module allows cells to stack inside the inner tube and mimics the shape of a ball pen. The ball-pen-like handheld main body contains two holes for cell inlets connecting to the inner tube space. A needle (21G) is attached to the needle holder, which can adjust the length of needle outside the holder and is connected to the main body to control the depth of injection. The tip end of the needle holder needs to avoid blocking the view during the injection. Since the cells should not mix before injection, a short spacing that contains air is introduced when the cells are loaded into the handheld module. This can be achieved by suitable distance between the two cell inlets (Fig. 4). Moreover, there is an angle stand attached near the tip to adjust the injection angle for less loading to the hand. The components of the handheld module are listed in Fig. 5. There are three parameters needed to be decided in the design, including the distance between the cell inlets at the inner tube, needle length outside the needle holder, and angle provided by the angle stand.

Cell #2 Spacing Cell #1

Fig. 4. The spacing between the two cells and distance between the cell inlets.

(a) handheld main body

(c) angle stand

(b) needle holder

(d) connector at cell inlet

(e) needle

Fig. 5. The components of the handheld module.

In order to find the suitable distance between the inlets, 3D printed prototypes with distances from 1 mm to 9 mm were fabricated and tested. Two dyed solutions (red and blue) that mimic the viscosity of cell solutions were used for testing. The results are summarized in Table 1. After 9 mm, the two colors can completely separate without any

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mixing, so 9 mm is considered the least distance required. On the other hand, larger distance indicates more air in between, but too much air may occupy the space for cells in the injection location, resulting in additional problem of cells stacking. Hence, 9 mm is chosen in our design. Table 1. Distance between the inlets and the results of loading mimicked dyed solutions Spacing (mm) 1–5 Mixed? Yes

6 Mostly

7 Partial

8 Mostly not

9 No

The needle length outside the needle holder is determined by needle’s tip length and the injection depth. The opening of the needle’s tip is an inclined region. During the injection, this region should be immersed in the skin. The measured tip length of 21G needle containing the inclined region was 3.64 mm. In general, the depth of epidermis layer is about 2 mm and the cells are intended to implant in this layer, so the injection depth should be less than 2 mm. That is, 3.64*sinθ should be less than 2. The angle, θ, need to be less than 33.3°. If 30° is chosen, the needle length outside the needle holder can be set as 3.8 mm, resulting in the injection depth to be 1.9 mm. Setting the injection depth close to 2 mm will allow more space for cells to stay inside the epidermis without being squeezed out. Angle stand with 20°, 25°, and 30° were compared. 3D printed samples were adapted to evaluate the comfort of holding the handheld module. The feedback shows that larger angle is better. If we compared to the angles (45°–60°) while we are writing, 30° is still less. However, we have another limitation from the injection depth and the needle size chosen. 30° is considered to be the most suitable option for the design. 3.3 Pneumatic Source and Settings The pneumatic source utilized in this study is a ZGPCO1000 micro-injector (ZGene Biotech Inc., Taiwan) (Fig. 6). The micor-injector can output steady air with the pressure setting from 1 to 90 psi and injection duration from 0.01 to 99.99 s. The initial test were conducted within the tube with a segment of cell-mimicked fluid. When the pressure is greater than 4.3 psi, the air would intrude into the fluid and separate it into several sections. Thus, the pressure should not go higher than 4.3 psi. Further tests were performed on the implanter prototype. When the pressure is higher than 3.1 psi, the cellmimicked solution would be pushed back. Once the upper limit of the pressure is under‐ stood, corresponding pressure and injection duration for different injection amounts should be determined. For animal test which requires 50 μL of cells, the suitable setting is 1 psi and 0.3 s. For less volume, for example 5 μL for human body test, 0.2 psi and 0.2 s are enough.

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Fig. 6. Pneumatic source—ZGPCO1000 micro-injector

4

Prototype and Simulated Test

The assembles prototypes for the cell loading control module and handheld injection module are shown in Fig. 7. The structure components in the cell loading control module and the angle stand in the handheld injection module were 3D printed. Other parts of handheld devices, including the main body and needle holder were made out of nontoxic acrylate. The handheld injection module is similar to a pen and can be hold easily (Fig. 8). The total weight of the handheld module, including main body, needle holder, needle, angle stand, and 20 mm long silicone tubes, is only 12.08 g, which is similar to a ball pen (11.58 g). During the holding, the weight center of the device falls around 2– 3 cm lower than the location between the thumb and index finger, which can distribute the loading effectively and reduce the burdens.

(a) cell loading control module

(b) handheld injection module

Fig. 7. The assemble prototypes of different modules.

Fig. 8. Demonstration of holding the handheld injection module (left) and during injection (right) supported by the attached angle stand.

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The operation flow of the implanter is summarized in Fig. 9. After pressing the button to load the cells into the handheld module, the needle pierces the scalp at the planned location with assistance and support from the angle stand. Step on the paddle to trigger pneumatic source, and stacking cells are pushed by air to implant into the skin. The needle is then released, ready for the next cycle. Taking the volume of 50 μL as an example, it takes 0.8 s for cells loading and 0.3 s for injection. The cycle time for each implantation is only 1.1 s.

Load cells

Select implantation location

Pierce Needle in

Step on the paddle to trigger injection

Release Needle

Fig. 9. The operation flow of the implanter

Some simulated tests were conducted. Dyed red and blue solutions with similar viscosity to cells were utilized to test the loading volume pushed out by the cell loading module. Ten measurements for each color and for different volumes (50, 20, 10 μL) using blue solution were averaged and the standard deviations were calculated. The results are summarized in Table 2. The averages were all close to but less than our target volume. The standard deviations were similar, not varied by the push-out amount. For further comparison, the outlet diameter of the syringe was changed from 3 mm to 1 mm, and the loading test of the 50 μL was repeated. The standard deviation was reduced when the smaller outlet diameter was adopted. This may be due to the effect of fewer left-over drops near the smaller outlet. The simulated cell stacking test was to confirm implanta‐ tion results after injection. A transparent silicone block was utilized for clear observa‐ tion. Considering two dyed water-based solutions will diffuse rapidly and mix together, incompatible silicone oil and blue solution were used. Silicone oil with less density was the first section to be injected, while blue solution was the top layer. The successful stacking result is shown in Fig. 10. Table 2. Simulated cell loading tests for different volumes. Outlet diameter Target loading volume (μL) Average (μL) Error (%) Standard deviation

3 mm 50 (red) 49.56 0.88 1.19

50 (blue) 49.85 0.30 1.39

20 19.94 0.30 1.23

10 9.87 1.30 1.19

1 mm 50 49.85 0.30 0.68

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Upper layer: blue solution Lower layer: silicone oil Fig. 10. Simulated cell stacking result

5

Conclusion

In this research, a pneumatic duel-cell stacking implanter was developed. The design was not only to fulfill the function needs, but also considered the human factors for the doctors. In order to reduce the burden of the hand during operation, the implanter was divided into separated modules, so that the handheld module is light and easy to hold like using a ball pen. The pneumatic trigger is controlled by foot stepping, avoiding the repeated finger motion thorough the long period of operating time. The simulated tests were conducted to verify the performance of the implanter, and necessary parameters were determined. As a result, the implanter can successfully inject the duel solutions into the same location with the stacking effect, and the operation process satisfied the human factor considerations. The handheld module only weighs 12 g and no extra loads required by hand during the implantation. The implanter is also applicable to other similar applications when two types of cells/solutions are needed.

References 1. Stenn, K.S., Cotsarelis, G.: Bioengineering the hair follicle: fringe benefits of stem cell technology. Curr. Opin. Biotechnol. 16, 493–497 (2005) 2. Young, T.-H., Lee, C.-Y., Chiu, H.-C., Hsu, C.-J., Lin, S.-J.: Self-assembly of Dermal Papilla Cells into Inductive Spheroidal Microtissues on Poly(ethylene-co-vinyl alcohol) membranes for hair follicle regeneration. Biomaterials 29, 3521–3530 (2008) 3. Yen, C.-M., Chan, C.-C., Lin, S.-J.: High-throughput reconstitution of EpithelialMesenchymal interaction in Folliculoid Microtissues by biomaterial-facilitated self-assembly of dissociated heterotypic adult cells. Biomaterials 31, 4341–4352 (2010) 4. Choi, Y.C.: Single-hair transplantation by Choi’s procedure. Int. J. Cosmet. Surg. Aesthetic Dermatol. 2(3), 187–194 (2000) 5. Boudjema, P., Boolauck, S.J.: Automated hair transplant system: the Boudjema technique. In: Stough, D.B., Haber, R. (eds.) Hair Replacement: Surgical and Medical, pp. 370–374. Mosby, St. Louis (1996) 6. Lee, S.J., Lee, H.J., Hwang, S.J., Kim, D.W., Jun, J.B., Chung, S.L., Kim, J.C.: Evaluation of survival rate after follicular unit transplantation using the KNU implanter. Dermatol. Surg. 27(8), 716–720 (2001) 7. O’Brien, J.A., Lummis, S.C.: Diolistics: incorporating fluorescent dyes into biological samples using a gene gun. Trends Biotechnol. 25(11), 530–534 (2007) 8. Injex. http://www.injexuk.com

Development of Pneumatic Dual-Cell Stacking Implanter 9. Zeranol Ralgro. http://www.ralgro.com 10. Gilson, Inc. http://www.gilson.com 11. MAFT-GUN®. http://www.maft-gun.com

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Human Factors in Prosthesis of Total Knee Arthroplasty ( ) Rene Pimentel1 ✉ , Cristiano Fontes1, Salvador Àvila1, Jocelma Rios2, 1 Adonias Magdiel , Cristiane Fragoso2, Ivone Cerqueira1, and Caroline Massolino1

1 Industrial Engineering Program, Federal University of Bahia, Salvador, Bahia, Brazil {pimentel,cfontes,avilasalv,adoniasmagdiel,ivonec}@ufba.br, [email protected] 2 Federal Institute Bahia, Lauro de Freitas, Bahia, Brazil [email protected], [email protected]

Abstract. This article presents an analysis of proposal on the useful life of pros‐ theses Total Knee Arthroplasty (TKA), from five interdependent dimensions that affect this phenomenon, namely, engineering, human factors, biomaterials, health and monitoring technology. The hypothesis is that the useful life of the prosthesis, which reveals its potential failure, is strictly and directly related to the occurrence of all dimensions simultaneously. The mental representation of health and disease, which interferes with human behavior on health and disease, underlying the importance of human factors in this analysis. Keywords: Human factors · Total Knee Arthroplasty · Prostheses

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Introduction

The Total Knee Arthroplasty (TKA) is one of the most innovative surgical interventions in orthopedics. It is commonly held in people with advanced osteoarthritis knee and also for other diseases such as rheumatoid arthritis, psoriatic and post-traumatic [1]. With aging world population, it is expected a significant increase in the occurrence of osteo‐ arthritis of the knee and hip, and consequently an increase in the number of surgical interventions, such as the TKA. Brazil has been presenting typical social change in developing countries, such as aging of the population [2] and obesity growth [3]. It is estimated that in 2060 the percentage of people over 50 years reach almost 50% of the population, which represents a significant change in the structure of Brazilian society [2]. These factors are directly linked to the genesis of osteoarthritis, which predicts that the demand for joint replacements grow exponentially in the coming years [4]. These surgeries are aimed at reducing the pain and disability, improve functional status and thus restore the quality of life of people who have in TKA the last chance to preserve the health [5]. However, because of TKA prostheses have limited lifetime, the patient needs to undergo revision surgery a few years after the first, which is configured as a stress vector for the user, compromising the desired quality of life. This article presents an analysis of proposal on the useful life of prostheses for TKA, from five interdependent

© Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_53

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dimensions that affect this phenomenon, namely, biomaterials, engineering, health, human factors, and monitoring technology. The hypothesis is that the useful life of the prosthesis, which reveals its potential failure, is strictly and directly related to the simultaneous occurrence of all dimensions. In other words, the useful life is considered here a dependent variable, that can be explained by a mathematical function whose independent variables are grouped in these five dimensions. In practice, caring for lifetime of the prosthesis must be present from the stage of research and development, in its design and specifications, in its production, in its implementation, the recovery of the patient, the behavior of maintenance and monitoring of conditions the prostheses within the human body. The relevance of these reflection proposed based on the possibility of helping to clarify issues about occurrence and predictability of failures in TKA prostheses. Moreover, it is important highlight the significant increase in the amount of TKA procedures. Concurrently, the growth is observed at the failure occurrence frequency, which can lead to the need for early corrective surgery (review). The undesired result of a review may be a new wear on the organic system tissues, especially the bone, making the recovery of the patient and lowering the success rate of revision procedures. This aspect becomes even more critical considering that more and more young people are undergoing surgical procedures of TKA, due to increased exposure to risk factors as motorcycle driving, practice of high impact sports, obesity and physical inactivity. In the proposed function, the engineering dimension considers aspects related to the manufacturing process, ergonomics, anthropometry and usability research and level of technological development, quality control, storage and distribution, patents, in addition the specifications of the prosthesis fixation procedures in the organic system. The biomaterials dimension comprises metallic implants, ceramics, polymers and compo‐ sites, with their mechanical characteristics, electrical, thermal, magnetic, optical, and chemical degradation. The dimension health includes health diagnostic, surgical and physical therapy procedures, physical therapy equipment, infection control, pre and post surgery, all permeated by procedural technology, own informational and instrumental. The dimension monitoring technology considers recent innovations in monitoring the organic system union with the prosthesis through Micro Electro Mechanical Systems (MEMS) embedded. The dimension human factor represents the ‘level of conscious‐ ness’ user about its limitations and possibilities pre- and post-implantation. It is asso‐ ciated with social behavior involving health and disease, which go far beyond the phys‐ iological aspect and are difficult to define and measure. They cover a wide range of experiences and events, and its interpretation may be on the social context and norms. As such, individuals, groups, institutions and society can have very different interpre‐ tations of what is disease and what means be in good health.

2

Engineering Dimension

Although the knee is classified biomechanically as a hinge joint, its kinematics are more complex, involving motion in variable axes and in three separate planes. Moreover, the stability of the joint is highly dependent on the ligaments and other soft tissues around

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it (joint capsule, menisci, pes anserinus, iliotibial band, popliteus tendon). The perform‐ ance of a satisfactory TKA requires a comprehensive knowledge of both anatomy and biomechanics, correct and accurate surgical technique and the use of the appropriate implants. The implant design should promote normal knee function and minimize the risk of implication. The quality of the implant is intrinsically linked to its durability, which means that there are stages through which it must pass while maintaining the same standard of performance and effectiveness, and stay safe until the end of its useful life. A safe implant can be defined as “one that is designed and manufactured so that their use does not compromise the clinical condition and safety of patients, operators and others when used under the conditions and intended purposes” [6, 7]. The revisions mentioned above, in a way, compromise the clinical condition and safety of patients. Being unwanted, you can see clearly an effort to research and development of process engineering and health involved with TKA prostheses, to avoid them. Currently, there are numerous types of prostheses from different manufacturers. The choice of the type of prosthesis to be used in surgical procedures is influenced by some factors. Among them are the socioeconomic and epidemiological conditions of the patient, the surgeon’s familiarity with a specific procedure and the quality of instruments and implants, and the availability of certain brands over others, mainly for logistical issues. Anthropometric aspect is a factor that give a lot of uncertainty in the prosthesis design and the surgical procedure because a significant portion of patients undergoing TKA in Brazil and other countries, differs above the acceptable between the dimensions of the knees and implants studied, which may compromise clinical outcome and durability of the surgery. The amount of implants is small compared to anatomical variability, whichmay be considered because of incompatibilities. Loures and colleagues [4] devel‐ oped a study between 2012 and 2013, which found that the average rate of femoral ratio is 111%. The authors compare their study with several others made in different countries, and found that the problem does not have to do with ethnicity or gender. They concluded that adjustments need to be made in the manufacture of prostheses so that they can respond more adequately to growing demand. The implant manufacturing stages varies greatly depending on the nature of the biomaterials, but can be basically: machining, turning, polishing, electropolishing and passivation (the latter two in metals), cleaning,individual marking, packaging, labeling, sterilization, pressing and sintering (the latter two in ceramics). In the prosthesis manufacturing process it is vital to have a strict quality control and technical specifications in the selection of biomaterials used. The lack of this care often leads to failure by corrosion and subsequent breakage of the implant or local reactions by metal oxidation and production of aseptic inflammatory reaction [8]. In addition to using biocompatible materials, there should be very tightly as the implant design, implementation and specific instrument for the prosthesis [8]. Due the growing demand for TKA prostheses, there is need to reflect on the best type of prosthesis to be used, considering the cost/effectiveness of the surgical procedure [7]. In Brazil, still predominate, due the low cost, manufacturing and steel prosthetic implants, phase already fully overcome by metal alloys, and more recently by ceramics and composites.

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511

Dimension Biomaterial

Studies and procedures for total or partial replacement of the elements of the knee have been made since the nineteenth century, with great advances in TKA in middle of last century, the development of new biomaterials used in joint interposition [9]. The bioma‐ terial available for manufacture of implants are organized into classes, namely, poly‐ mers, metals and metal alloys, ceramics and composites. Synthetic polymers are readily adaptable materials to exercise a wide range of func‐ tional properties and it is possible manipulate, as the shape and size of the devices, as well as some their mechanical properties [10]. They have good elasticity, easy manu‐ facturing and low density. However, they have low mechanical strength and degrade over time [11]. Despite the appropriate functional properties, these materials generally do not exhibit favorable chemical groups to cell interaction and may also release toxic by-products into the bloodstream during degradation, which might trigger inflammatory reactions in the patient throughout its use. The cobalt and chromium alloys for applica‐ tions as biomaterials are associated primarily to orthopedic prostheses for knee, shoulder and hip [12]. Ceramic biomaterials are composed of metallic elements and non-metallic [13]. They can be classified according to their interaction with the host tissue as bioi‐ nertes, bioactive and bioresorbable. They have the advantage of being inert, with good corrosion resistance, good biocompatibility and high compressive strength. However, its manufacture is complex, has low elasticity, high ductility and low density [11]. In general, ceramics are less dense than most metals and alloys. Moreover, they have the advantage of dimensional stability and wear resistance to compression and stability in acidic environments. Their low density and ease of forming are important properties when the application involves the manufacture of prosthetic and orthotic [12]. The composites have great potential for use as biomaterials and are in constant development, since it enables adjust the mechanical and biological performance, for several specific situations. Thus biomaterials chosen for manufacturing a prosthesis must take into account characteristics of resistance, biocompatibility and biostability. Although there is no material with all three characteristics in absolute terms, the improvement for search is essential, as will result improved durability of the implant in the patient [14]. It is believed that the knee prosthesis made Zirconium based alloy has higher durability than the cobalt-chromium alloy prostheses [10, 12]. Despite the advances made in recent decades [15], there are still limitations on the prostheses used in the implants. Considering the increase in population longevity, it is crucial to able prolong the durability of prostheses, through effective monitoring, technological improvements, including the choice of more resistant biomaterials and behavioral recommendations for individual users [15].

4

Health Dimension

TKA requires review every 15–20 years, so if ideal conditions occur simultaneously. This can be a big problem for younger users who are at risk of going through many revisions throughout life, with every surgical procedure more bone loss, making the

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fixation of the prosthesis. Thus, the useful life of the graft mechanism becomes a critical aspect for the user quality of life. The medicine innovations are already underway, such as minimally invasive surgery vs. traditional surgery, severe surgery technology with digital monitoring, biomaterials last generation used in components, fastening with cement vs. cementless, fixed vs. mobile platforms, design for large mobility and align‐ ment techniques of the components. Even with this development, the causes of review, especially early, occur, 29% of them at the expense of poor positioning of the implants. In recent years, surgeons, engineers and computer technicians have joined together to develop new computerized helper methods to improve the placement of TKA compo‐ nents. In this context, Computer Assisted Surgery (CAS) aims to improve the quality and accuracy of TKA through information provided to the surgeon during surgery [16]. The principle common to all computer systems is possible, from solidly fixed to the bone captors, recognition of bone surfaces palpated patient for an instrument calibrated. The system also recognizes the joint space using a fixed sensor to the instrument. The position of all fixed or mobile sensors is identified by infrared electromagnetic or optical camera system [16]. Computed tomography help reconstruction in three dimensions (3D), because it defines the major landmarks during surgery that define the axes and the height of the bone cuts. The correspondence between the anatomical points palpated in the bone itself and the points programmed preoperative examination is obtained from computer program. This program merges the images and displays on the handset screen, making the 3D representation of the anatomical parts and the precise position of surgical instru‐ ments calibrated. This way, the navigation in real time is possible, knowing the position of the instruments, the position and size of the implants in relation to the articular surface, as well as control the orientation of the bone cuts without intra or extra-medullary guide.

5

Monitoring Technology Dimension

With regard to monitoring methods, the practice developed by health professionals focuses on clinical, supplemented by radiological imaging and, ultimately, with the revision surgery. The most used means for obtaining data about the prosthesis and the surrounding regions are technologies that often require a long time of doctors and patients, and high resources, and sometimes do not have as accurate information compared to what could be obtained with implanted devices [17]. The less invasive methods, which are monitoring the distance are still a promise. In the radiology’s field, medical procedures for investigation of the clinical presentation, and for monitoring purposes [18], they are made by examinations using proper techni‐ ques for patients and effective in the context of reducing the effects generated from exposures radiation. Among the most used techniques include: X-ray, CT and MRI [19– 21]. Thus, besides the diagnosis, when defining the need for TKA surgery, imaging tests now have another role, which is to monitor the health status of the patient, monitoring the recovery of tissues undergoing surgery, adaptation of the prosthesis and the neces‐ sary adjustments generated from the natural aging of the bones connected to the pros‐ thesis in addition the appearance of infections [21].

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To reduce the incidence of revision surgeries, thus prolonging the useful life of the prosthesis has been studied and applied methods of monitoring “less invasive” such as the use of Micro Electro Mechanical Systems (MEMS) [17], comprising electronic elements, mechanical, sensors and actuators and biosensors, devices in which substances are introduced as proteins, enzymes, antibodies, DNA, among others, in order to perform specific measurements. Such devices allow significant advances in monitoring pros‐ theses, implants and postoperative conditions in order to better serve the user [23]. Specifically in the health area, the applications of MEMS have diversified significantly, because both can be used for sensing as to act [24]. They can be allocated in six different categories: pressure sensors, inertial sensors, microfluidic fluid, clinical analysis, optical and radio frequency (RF) [25]. The use of these devices brings many features not previously found, resulting in reduced costs, fewer visits to the doctor and greater independence of the patient in rela‐ tion to health professionals, enabling homecare services more affordable by allowing realtime monitoring [26], in addition to providing more security when monitoring patients receiving prolonged treatment [27]. Sasikala, Joseph Daniel and Bharathi devel‐ oped with a bio-MEMS strain sensor, which allows observation distance bone healing process in fracture repair surgery [28]. This sensor can anticipate adverse situations in the healing process, preventing the occurrence of surgical repair, which you can not do using only the X-ray as monitoring method. Ortho-Tag developed a MEMS technology that allows access to implant information, without the need to perform invasive proce‐ dures through a reader Radio-Frequency Identification (RFID) specific. The information obtained from this MEMS are related to the surgical procedure, such as the name of the surgeon, hospital, prosthesis manufacturer, date of procedure, etc. Besides these static information, this device promises to dynamic data readings related to infectious agents. For this, we have integrated biosensors that transmit data through Transcutaneous Near Field Communication (TNFC) [29]. The choice of the appropriate method based on specific information and are within the limits of applications of each, and you can also merge techniques to increase diagnostic accuracy and tracking.

6

Human Factors Dimension

6.1 Study of Mental Representation in Health and Illness Pew social and behavioral scientists would disagree that the understanding of people about the events is a primary determinant of its responses to those events [30]. The notion that individuals respond to the world as they see, not necessarily how it is achieved the witness status utility simple idea that individual mental representations of events somehow matter. These mental representations of health threats of patients, determine how respond to these threats [31]. Considering the problem of patient adherence to treatment regimens, the study by Leventhal and colleagues [31] demonstrated that patients employ implicit theories of disease (disease schemes) to achieve an under‐ standing of the threats to health and regulate their health behavior. In this sense, they say that the role played by psychological, social and cultural factors on human health, and health-related behaviors, deserves special attention by the basic questions of

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identifying potential on how the individual thinks about health and disease, leading into account concepts of anthropology, biomedicine, psychology and sociology [30]. And these issues have been subject of medical anthropology, concerned about the meanings assigned culturally and transmitted, we benefited from the development of alternative explanatory structures, used to explain symptoms and diseases in other cultural groups [30]. For Western psychologists, awareness of cross cultural variation in collective repre‐ sentations of illness and disease raises the possibility that: (1) individual health and sickness vary within a culture; (2) such variations may help explain variation in health - and behaviors related to the disease. In the field of medical sociology, Mechanic also helped stimulate interest in fundamental questions of representation of the disease [32]. The insightful analysis of Parsons on the character of American institutional medicine helped raise awareness of the goals sometimes incompatible health professionals and their clients [33]. The description of doctor-patient meetings by Hayes-Bautista as “negotiations”, tries to further characterize the differences in the way mental represen‐ tations of lay may conflict with the health professional [34]. Although individuals involved in the Western biomedical tradition to share some of the assumptions of their health care providers, it is now clear that the laity can interpret threats to health and treatment, very differently from those who have the responsibility to diagnose applying threats updated techniques. Although anthropology and medical sociology provide a number of ideas on issues of representation, both methodologies as levels of analysis employed in these disciplines prevent a large extent, we can not answer questions about the structure of individual representations of lay diseases. Observing closely the parallels between health beliefs and more general concepts of cognitive psychology, the disease schemes idea also provided a context for the integration of a growing literature on the determinants of symptomatic experience and behavior of symptoms [35, 36]. The representation of the disease processes, especially the ways people value their own health status, also experienced increasing scrutiny. Jemmott and colleagues exam‐ ined the ways in which individuals react to information about their own health status [37]. In line with the proposition that the information processing strategies in cognition of the disease are simply special cases of more general strategies, these researchers found that heuristics simple can explain the seriousness with which people regard the news that have a disease. In addition, they found that the threat of implications of the disease depend on quite surprising ways on the perceptions of the population prevalence of those diseases [38]. Disease cognition studies are numerous enough to merit a special mention in the review field of health psychology [39, 40]. This should indicate the extent to which the emphasis on mental representational, became an influential force in the social and behavioral sciences, who care about health. 6.2 Models Common Sense of Disease At the scope of health psychology, one of the research areas developed in recent decades was the common sense of the models on the [41] disease. These models have been of

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great importance because of the implications on behaviors related to health and adap‐ tation, or recovery from an illness. Are representations which have an idiosyncratic character and orient the individual reactions symptoms, the diagnoses, or other infor‐ mation related to the disease. Individuals act as scientists “lay” in the construction and upgrading of their illness representations, in order to restore the balance of your health. The importance of psychological factors in health management has been growing in recent decades, particularly with regard to issues related to how individuals think about health and disease. Leventhal and colleagues pioneered this approach argue that indi‐ viduals construct mental models, or implicit models of the disease, about how a disease can affect bodily functions, and the individual’s daily life, if and how it can heal, and how to restore the health status [42–45]. Figueiras [41] further states that these models determine the answers to the symp‐ toms, the treatment adherence and health professional recommendations; and developed from exposure to a set of social and cultural character of sources, such as the dissemi‐ nation of news in the media, personal experiences with the disease, indirect experiences with family and friends, reports of information published in books, movies, documen‐ taries, or information taken from the internet. The individual is active in the construction of their representations, and information is integrated in accordance with pre-existing mental schemes, thus producing a common-sense model of the disease. Various studies using different samples and methodologies confirmed that the models of common sense on diseases have a similar structure or in ill patients or in healthy subjects [46, 47] and have important implications for adherence to therapeutic regimens [48–50].

7

Conclusions

The human factors essentially interfere at the longevity of the prosthesis, in that the different representations of health and disease are responsible for miscommunication between physicians and patients and therefore with researchers and manufacturers because entire improvement prosthesis depends, in large part, the feedback of the results of those who use them at work or in life. These failures can lead to inappropriate behavior of patients, considering the recommendations of manufacturers and medical, bringing therefore damage to the useful life of the prosthesis, and therefore to the user health. Therefore, the theme quality of implants should receive special attention when it comes to durability and safety throughout their life cycle. In Brazil, the research of biomaterials and innovative projects has been constant in the academic community, but in industrial practice, most manufactured prosthetics are products reproductions enshrined in the international market, with expired patents, so technologically outdated, with small improvements developed in parents. The care in the choice of raw materials, the size requirements and accurate drawings and accurate implementation techniques, demon‐ strate that the theme “quality prosthetics” is multidisciplinary. Manufacturing involves bioengineering and storage is inextricably linked to strict health standards, requiring professional engineering, health and administration; the insertion of the prosthesis requires human resources in the medicine areas, biomechanics, physical therapists and nursing. The post-implant monitoring requires patient compliance, which must notify

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the orthopedic surgeon any reactions, fever, swelling of lower limbs and difficulty of articulation. In other hand, the guidance on the limitations that the prosthesis will result in your daily habits is the medical professional liability, which must be aware the complex consequences of sickness and mental health of their patients.

References 1. Kiorpelidis, P.I., et al.: Long term outcome of primary Total Knee Arthroplasty: the effect of body weight and level if activity. In: Karachalios, T. (ed.) Total Knee Arthroplasty: Long Terms Outcomes, pp. 55–68. Springer, London (2015) 2. Instituto Brasileiro de Geografia e Estatística - IBGE: Brazil Population Projection by sex and age: 2000–2060 (2016). http://www.ibge.gov.br/home/estatistica/populacao/projecao_da_ populacao/2013 3. Associação Brasileira para o Estudo da Obesidade e da Síndrome Metabólica - ABESO. Map of Obesity. http://www.abeso.org.br/atitude-saudavel/mapa-obesidade 4. Loures, F.B., et al.: Anthropometric knee and its correlation with the size of three implants available arthroplasty. J. Orthop. 51(3) (2016) 5. Hamel, M.B., Toth, M., Legedza, A., Rosen, M.P.: Joint replacement surgery in elderly patients with severe osteoarthritis of the hip or knee. Arch. Intern. Med. 168, 1430–1440 (2008) 6. Agência Nacional de Vigilância Sanitária - Anvisa: Resolução RDC n. 56, de 6 de abril de 2001 (2001) 7. Conselho Federal de Medicina - CFM: Resolução CFM n. 1.956, de 25 de outubro de 2010. Diário Oficial da República Federativa do Brasil, Poder Executivo, Brasília (2010) 8. Belloti, J.C.: Cenário atual do uso de próteses ortopédicas: discussão sobre próteses nacionais versus importadas. Diagn. Trat. 14(1), 9–11 (2009) 9. D’Elia, C., et al.: Tratamento das infecções pós Artroplastia Total de Joelho: resultados com 2 anos de seguimento. Acta Ortop. Bras. 15(3), 158–162 (2007) 10. Ratner, B.D., et al. (eds.): Biomaterials Science: An Introduction to Materials in Medicine. Academic Press, Oxford (2013) 11. Mendes Filho, A.A.: Síntese e caracterização de hidroxiapatita e compósitos a partir de matéria-prima reciclada. Tese (Doutorado em Engenharia de Materiais)–Universidade Federal de Ouro Preto, Ouro Preto (2006) 12. Pires, A.L.R., Bierhalz, A.C.K., Moraes, Â.M.: Biomateriais: tipos, aplicações e mercado. Quím. Nova 38(7), 957 (2015) 13. Rodrigues, L.B.: Aplicações de biomateriais em ortopedia. Estudos Tecnol. Eng. 9(2), 63–76 (2013) 14. Simioni, S.: Manual da qualidade de implante em artroplastia de quadril. Editora Universitária Champagnat, Curitiba (2012) 15. Karachalios, T.: Total Knee Arthroplasty: Long Terms Outcomes. Springer, London (2015) 16. Soares, L.F.: Artroplastia Total de Joelho Assistida por Computador. Dissertação (Mestrado em Medicina)–Programa de Pós-Graduação em Ciências Aplicadas à Cirurgia e à Oftalmologia, Universidade Federal de Minas Gerais, Belo Horizonte (2010) 17. Wang, W., Soper, S.A.: Bio-MEMS Technologies and Applications. RCR Press, Florida (2007) 18. Loures, F.B., et al.: Avaliação rotacional do fêmur distal e sua importância na Artroplastia Total de Joelho: análise por ressonância magnética. Radiol. Bras. 48(5), 282–286 (2015)

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19. Bushong, S.: Ciência radiológica para tecnólogos: física, biologia e proteção. Elsevier, Rio de Janeiro (2010) 20. Fuchs, R., Fuchs, T.: Revisão de artroplastia de joelho. Instituto Fuchs - Cirurgia do joelho e quadril (2015) 21. Landim, A., et al.: Equipamentos e tecnologias para a saúde: oportunidades para uma inserção competitiva da indústria brasileira. BNDES Setorial 37, 173–226 (2013) 22. de Carvalho Junior, L.H., Temponi, E.F., Badet, R.: Infecção em Artroplastia Total de Toelho: diagnóstico e tratamento. Rev. Bras. Ortop. 48(5), 389 (2013) 23. Zhang, X., Huangxian, J., Wang, J.: Electrochemical Sensors, Biosensors and Their Biomedical Applications. Elsevier, New York (2008) 24. Faccin, E.L.: Modelagem matemática da dinâmica de MEMS baseados em deformação elástica utilizando modelos polinomiais contínuos. Dissertação (Mestrado em Modelagem Matemática)–Programa de Pós-Graduação em Modelagem Matemática, Universidade Regional do Noroeste do Estado do Rio Grande do Sul, Panambi (2014) 25. Fraga, M.A., et al.: Carbeto de silício como material base para sensores MEMS de uso aeroespacial: uma visão geral. Matéria (Rio J.) 19(3) (2014) 26. de Morais, B.M.: InteliCare: infraestrutura de telessaúde para apoio a serviços de atenção domiciliar baseada em redes de sensores sem fio e sistemas embarcados. Dissertação (Mestrado em Informática)–Programa de Pós-graduação em Informática, Universidade Federal da Paraíba, João Pessoa (2012) 27. Stankivic, J.A.: Wireless sensor networks for in-Home healthcare: potential and challenges. In: 2nd High Confidence Medical Device Software and Systems Workshop, Philadelphia (2005) 28. Sasikala, S., Joseph Daniel, R., Bharathi, N.: Simulation of RF-MEMS bio implantable sensor for orthopedic application. In: 14th International Conference on Innovations in Engineering and Technology, Tamil Nadu, India, vol. 3(3), pp. 631–635 (2014) 29. Ortho-Tag. http://www.ortho-tag.com/index.html 30. Skelton, J.A., Croyle, R.T., Skelton, J.A., Strohmetz, D.B.: Priming symptom reports with health-related cognitive activity. Pers. Soc. Psychol. Bull. 16, 449–464 (1990) 31. Leventhal, H., Meyer, D., Nerenz, D.: The common sense representation of illness danger. In: Rachman, S. (ed.) Contributions to Medical Psychology, pp. 7–30. Pergamon Press, New York (1980) 32. Mechanic, D.: Medical Sociology, 2nd edn. Free Press, New York (1978) 33. Parsons, T.: The Social System. Free Press, New York (1953) 34. Hayes-Bautista, D.E.: Modifying the treatment: compliance, patient control, and medical care. Soc. Sci. Med. 10, 233–238 (1976) 35. Pennebaker, J.W.: The Psychology of Physical Symptoms. Springer-Verlag, New York (1982) 36. Pennebaker, J.W., Skelton, J.A.: Selective monitoring of bodily sensations. J. Pers. Soc. Psychol. 41, 213–223 (1981) 37. Jemmott, J.B., Ditto, P.H., Croyle, R.T.: Judging health status: effects of perceived prevalence and personal relevance. J. Pers. Soc. Psychol. 50, 899–905 (1986) 38. Jemmott, J.B., Croyle, R.T., Ditto, P.H.: Commonsense epidemiology: self-based judgments from laypersons and physicians. Health Psychol. 7, 55–73 (1988) 39. Rodin, J., Salovey, P.: Health psychology. Annu. Rev. Psychol. 40, 533–579 (1989) 40. Taylor, S.E.: Health psychology: the science and the field. Am. Psychol. 45(1), 40–50 (1990) 41. Figueiras, M.J.: A relevância dos modelos de senso comum da doença para adesão terapêutica. Rev. Factores de Risco 11, 38 (2008)

518

R. Pimentel et al.

42. Leventhal, H., Diefenbach, M.: The active side of illness cognition. In: Skelton, J.A., Croyle, R.T. (eds.) Mental Representation in Health and Illness, pp. 247–272. Springer Verlag, New York (1991) 43. Leventhal, H., Diefenbach, M., Leventhal, E.A.: Illness cognition: using common sense to understand treatment adherence and affect cognition interactions. Cogn. Ther. Res. 16(2), 143–163 (1992) 44. Leventhal, H., et al.: Illness representations: theoretical foundations. In: Petrie, K.J., Weinman, J. (eds.) Perceptions of Health and Illness: Current Research and Applications, pp. 195–220. Harwood Academic, Amsterdam (1997) 45. Leventhal, H., Brissete, I., Leventhal, E.: The common-sense model of self regulation of health and illness. In: Cameron, L., Leventhal, H. (eds.) The Self-Regulation of Health and Behaviour, pp. 42–65. Routledge, London (2003) 46. Figueiras, M.J.: A relevância dos modelos de senso-comum da doença para a adesão terapêutica. Rev. Factores de Risco 11, 38–41 (2008) 47. Lau, R.R., Bernard, T.M., Hartman, K.A.: Further explorations of commonsense representations of common illnesses. Health Psychol. 8(2), 195–220 (1989) 48. Weinman, J., et al.: Causal Attributions for myocardial infarction in patients and spouses and their effects on behaviour change. Br. J. Health Psychol. 5, 263–273 (2000) 49. Horne, R.: Treatment perceptions and self-regulation. In: Cameron, L., Leventhal, H. (eds.) The Self-Regulation of Health and Behaviour, pp. 138–153. Routledge, London (2003) 50. Ross, S., Walker, A., MacLeod, M.J.: Patient compliance in hypertension: role of illness perceptions and treatment beliefs. J. Hum. Hypertens. 18(9), 607–613 (2004)

Mathematical Modeling and Ergonomic Study of a Pencil Through Numerical Simulation for Support of the Graphological Presumptive Diagnosis Luis González-Delgado1,2, Julio Verdugo-Cabrera1,2, Luis Serpa-Andrade1(&), Isaac Ojeda-Zamalloa1, Vladimir Robles-Bykbaev1, Fernando Pesántez-Avilés1, Olena Naidiuk2, and Ninfa González-Delgado2 1

2

GI-IATA, Cátedra UNESCO Tecnologías de apoyo para la Inclusión Educativa, Universidad Politécnica Salesiana, Cuenca, Ecuador {lgonzalez,jverdugo,lserpa,vrobles, fpesantez}@ups.edu.ec, [email protected] Maestría en Métodos matemáticos y simulación numérica en ingeniería, Universidad Politécnica Salesiana, Cuenca, Ecuador [email protected], [email protected]

Abstract. According to the World Health Organization, ergonomics is the science aiming to obtain maximum performance by reducing risks of human and technological errors, as well as potential hazards to the worker, while trying to reduce fatigue. Under this context, the present work is intended to develop an ergonomic pencil device capable of capturing graphological features that will help analyze psychological factors and to identify personality traits in individuals in the business or mental health environments. To validate the work with respect to the ergonomic perspective, 3 main aspects were studied: 1. Mathematical modeling for the analysis of deformations and tensions in the structure of a pencil, 2. Statistical validations to define sensor location sections where fingers will be placed, 3. Simulation of the geometry to verify results of established parameters. The results obtained from simulations will serve to define personality traits, and the statistical validations indicated whether the finger position average distance is adequate. Keywords: Mathematical-Modeling


Ergonomics
Simulation

1 Introduction In Ecuador there are children and adolescents who are forced to work from early childhood, while others live in situations of violence at home, school, etc. There are also instances where abandoned and orphaned children are subjected to different types of physical and psychological abuse within and outside the family nucleus or the developmental environment. These types of situations expose these children and adolescents to different traumas that prevent them from maturing adequately, since © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_54

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psychological abuse can produce various problems such as insecurity, low self-esteem, and anxiety among others [1]. In Ecuador in 2013 according to the Azulado Foundation, 51% of children between the ages of 6 and 11 years old reported that they had been victims of abuse [2]. On the other hand, the National Council for Children and Adolescents (CNNA) notes that 49% of children are mistreated by their parents, while 80% of child abuse deaths are not reported, or are reported as death certificates [2]. In studies conducted in adults, it was indicated that 80% of individuals who had been mistreated in childhood could be diagnosed with at least one psychological disorder [2]. Therefore, the need nowadays to take advantage of the rapid development of technology in order to include ICTs in various educational processes or rehabilitation of children and adolescents who have been victims of mistreat, where ICTs would develop into support tools for psychologists and therapists in charge of diagnoses and intervention processes. In the present day, the lack of technological tools to perform activities related to the psychological field, can be clearly noticed in areas such as neurology, psychiatry, geriatrics, pediatrics, oncology, cardiology, and also preoperative intervention, where the role of the psychologist as support professional to the patient is of major importance [3]. Depending on the psychologist’s area of performance he or she uses different tools to carry out various tasks, such as measuring intellectual capabilities, personality characteristics, preparing a person for a particular situation, etc. However, most of the tools that are used are tests, where some are based on questions that the patient must answer using a writing tool such as a conventional pen or pencil, which can provide graphological information. In this way, it is feasible to better analyze certain personality characteristics [3, 4]. Analysis and numerical simulation are determining factors before the elaboration of an instrument for writing analysis. Therefore, the lack of these studies can generate tools whose ultimate goal is altered by providing erroneous support to the mental health professionals who use it. The format of this paper is organized as follows, in the Sect. 2 was revised projects related to the graphological diagnosis and studies that incorporate mathematical processes for the making of the devices, in Sect. 3 establishes the methodology of study for mathematical modeling, in Sect. 4 the statistical validations and geometrical simulations to verify the results of the established parameters, finally the corresponding results are presented.

2 Related Work: Graphology, Ergonomics and Mathematical Model Around of 1678 Gottfried Wilhelm Leibniz wrote, “Writing almost always expresses in one way or another our talent, unless it is the work of a calligrapher,” which means that the spelling or characteristic features of a writing are susceptible to personality traits, Literature refers to eight graphical genres, which regardless of the application to which graphology is subjected, must always analyze these eight general aspects of the text:

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size, pressure, inclination, cohesion (degree of union or separation of letters), speed, form, direction and order [5]. In various investigations that have been reviewed in literature, the graphology of individuals is studied through systems that do not incorporate information technologies or technological tools, which can present a detriment by not taking advantage of the processes of analysis by means of computation. To perform the graphology, analysis tests are applied, where the specialist analyzes the writing features belonging to an individual according to the established parameters [6, 7]. It is worth mentioning that in the previous studies, parameters of the instrument used to take the graphological samples have not been considered. There are also works and studies that incorporate computer technologies that will be discussed below. Pop and Giurgiulescu indicate that a main component for a teacher to learn about the characteristics of his or her students may be software that with image recognition indicates their characteristics [8]. Other studies present the use of automata, neural networks and computer vision to define an individual’s gender according to the graphological features and image recognition of the signature [9, 10]. Studies on graphology analysis based on prototypes indicates that it is feasible to create devices to collect signals from pressure sensors and then analyze them by computers using fuzzy logic or similar techniques, to subsequently analyze the before mentioned signals and generate an analysis thereof [11]. Aubin has developed a research where he carried out the analysis of the “graphic signature” of each person and with these analysis characteristics such as trajectories, pressures, accelerations, angles, and forces controlled by weights, which is an experimental model to infer traits of writing forces of an individual [12]. These features serve to represent variations over time and use image recognition to determine writing characteristics. Under this context is the existence of devices that digitally analyze the aforementioned characteristics by presenting a signature or a signal [13, 14]. In the aforementioned works, a study of the graphological features is made without first considering an analysis of the instrument with which the graphological samples will be taken, which can be an important element for the subsequent analysis. There are different outcomes, for instance if written with a cylindrical shape pencil than if written with a triangular shaped pencil, or if it is written with a pencil of a certain diameter or weight.

3 Methodology The technological innovation in sensors is intended to complement the graphological process with an analysis of tensions and deformations produced by the forces acting on the pencil at the time of the writing process. Nowadays, sensors located in specific places are used to measure applied forces, which once communicated to a computer and allow analyzing signals during the process of writing. This study intends to extend the analysis of forces, the deformations and tensions that occurs throughout the pencil, as well as, the validation of positions to sensors placement. The stresses and deformations diagram will allow the generation of

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graphological patterns corresponding to a person with more accurate diagnosis established by a psychologist.

3.1

Study of Mathematical Modeling

For the analysis of the tensions and deformations in the pencil, the method of mathematical modeling by Finite Elements will be used, this is considering the structure or body under study by dividing discrete elements called finite elements, to which corresponding loads are applied (forces or pressures) and the conditions of bonding between them, then a system of equations is generated that are solved numerically by computational programs to obtain the state of efforts and point deformations along the whole structure or body analyzed which is also known as Nodal solutions [15, 16]. The fundamental basis of the method is the representation of the body by an ensemble of subdivisions called elements, which are interconnected through nodes that are used for various processes such as optimization for the nodal solution of various structures [16, 17]. The pencil as in the Fig. 1, being the subject of study can be considered as a beam-like element supported at its ends and subjected to bending, therefore the elementary theory of statically determined beams, of constant section subjected to concentrated loads and axial loads, can be applied.

Fig. 1. Sketch of pencil rendering applied loads

The case study presented in this proposal, aimed at finding out the stresses and deformations in flat surfaces considering the following hypotheses: 1. The dimension along z-direction is much smaller compared to the other dimensions in x y y. 2. The dimension in the direction of the thickness is uniform and symmetrical along the plane. 3. It is considered as a plate if the thickness is less than one tenth of the smaller of the dimensions in the plane. 4. The material is assumed to be linear elastic homogeneous and isotropic. The following is a study of the finite element of triangular type in two dimensions since according to the literature this is the appropriate element for the geometry of the object being studied, and for the case of structures of flat type and that will be used for the development of the calculations in the solid that proposes to analyze it, through the computer program ANSYS.

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Study of the Linear Triangular Element as an Application Model to the Object

The equations to be used for the stresses in a plate girder are the following: the equation of axial deformation: 2x ¼ y

d2v dx2

ð1Þ

equation of effort or tension: rx ¼ E 2x ¼ Ey

d2v dx2

ð2Þ

elastic equation: ð3Þ

v ¼ vðxÞ

The linear triangular element is a two-dimensional finite element determined by local and global coordinates. It is characterized by linear functions. This element can be utilized to determine the flat stress or problems of flat deformation in materials subjected to loads within an elastic process. The linear triangular element has modulus of elasticity, the Poisson ratio, and the thickness. Each linear triangle has three nodes with two degrees of freedom in each node as shown in Fig. 2. In this case, the stiffness matrix of the element is given by: ½k ¼ tA½BT ½D½B

ð4Þ

Where A is, the area of the element y is given by: ½2A ¼ xi ðyj  ym Þ þ xj ðym  yi Þ þ xm ðyi  yj Þ

ð5Þ

Fig. 2. Linear triangular element.

and the matrix [B] or shape matrix is given by: 2 b 1 4 i 0 ½B ¼ 2A c i

0 ci bi

bj 0 cj

0 cj bj

bm 0 cm

3 0 cm 5 bm

ð6Þ

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where bi ; bj ; bm ; cj ; y cm are calculated as: bi ¼ yj  ym , bj ¼ ym  yi ; bm ¼ yi  yj , ci ¼ xm  xj , cj ¼ xi  xm , cm ¼ xj  xi : For the case of flat stresses the matrix [D] is given by 2 1 E 4 v ½D ¼ 1  v2 0

v 1 0

3 0 0 5

ð7Þ

1v 2

and for cases of flat stresses, the matrix takes the following form 2 1v E 4 v ½D ¼ ð1 þ vÞð1  2vÞ 0

v 1v 0

3 0 0 5

ð8Þ

12v 2

It is clear that the linear triangular element has six degrees of freedom, two in each node, therefore, for a structure with n nodes, the global stiffness matrix K would be of size (2n  2n) since we have two degrees of freedom at each node, later the following equation is applied: ½KfU g ¼ fFg

ð9Þ

Where U is the global nodal shift vector and F is the global nodal force vector. In this step the boundary conditions are applied manually to the vectors U and F. Then the matrix equation [K] {U} = {F} is solved by dividing and eliminating by the Gaussian method. Finally, once the unknown displacements and reactions are found, the stress vector for each element is obtained as follows: By being frg ¼ ½Df2g and as frg ¼ fBgfug, the stress stays determined by the following expression: frg ¼ ½DfBgfug

ð10Þ

Where r is the voltage vector in the element (of size 3  1) and u is the element displacement vector (6  1). The vector r is written for each element as: frg ¼ ½rx ry sxy T

ð11Þ

4 Statistical Validations to Define Sensor Location Sections The study of forces and restrictions present in the pencil is carried out with a sample corpus of 20 people taking the data of pressure and position of the forces to define the respective simulations and placement of the sensors for the following triangular geometry (Fig. 3).

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Fig. 3. Linear triangular element

To validate the distances average of each finger that holds the pen, it is necessary to validate if the average or median measurement is correct, being that the position of the sensors will be subsequently defined, using this measurement will calculate the values of central tendency with the purpose of validating the data as a result of the product that the coefficient of variation and coefficient of asymmetry yield, to the smaller variation coefficient then greater homogeneity and according to the coefficient of symmetry it is established that it is useful to calculate the median and not the average of data. With a population of 20 persons the following result is established (as shown in Table 1): Table 1. Statistical data regarding the measurements of the fingers and the tip of the pencil. Measurements Average Median Mode Stand. deviation Coeff. variation Type of population Coeff. asymmetry

Thumb 32.1 32 32 1.8 6 Homogeneous −0.4

Index 30.9 31 32 7.4 24 Homogeneous −1

Medium 31.6 32 32 9.9 31 Heterogeneous −0.8

Cancel 31.5 31.5 x 13.2 42 Heterogeneous 0

According to the previous table, the coefficient of variation indicates that the data are somewhat homogeneous, tending to be totally heterogeneous, whereas the coefficient of asymmetry validates the process since its range is between +3 and −3, concluding that it is more convenient to expose the results through medians, which gives an outcome of variation between distances as indicated in the following graph (as shown in Fig. 4).

Fig. 4. Distance between each finger at the end of the pencil

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With the above displayed results, the simulation is performed according to the data of the medians that were validated using the asymmetry coefficient, in such a way that the new geometry is established by the Inventor software and then imported to ANSYS WOKBEANCH software to proceed with the simulation as indicated in the following graphs (as shown in Fig. 5):

Fig. 5. Geometry and sensor placement section

5 Results For the finger force measurement case, i.e. when the pencil was pressed, the pressure sensors were used, which gave average results between 1N and 1.5N for each sensor, this data will be introduced in the simulation using the ANSYS WORKBEANCH software to perform an adaptive and refined mesh with 17267 nodes and 8781 elements as follows (as shown in Fig. 6):

Fig. 6. Geometry with refined mesh

Restrictions are applied and corresponding areas defined by the position of each finger according to the statistical validations previously studied, obtaining the following graph (as shown in Fig. 7).

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Fig. 7. (a) Areas of the finger positions. (b) Geometry with deformation results

When applying the solution of forces, stresses and deformations the following results are obtained (as shown in Tables 2 and 3): Table 2. Deformation data analysis Minimum Maximum 0m −1,7105e−006 m 3,0744e−005 m 2,6809e−005 m Table 3. Stress data analysis Minimum Maximum −4,0793e+005 Pa 2,3933e−024 J 7,2035e+005 Pa 1,0684e−007 J

While the minimum required deformation energy is 1 [J] and the maximum is 2.39 [J].

6 Conclusions and Future Works In the present study, researchers established that the maximum deformation, maximum stress, and distances from the tip are maintained by 4 factors which allow relating personality characteristics of individual, the same for the psychology, which represents important parameters of analysis to determine traits specific to the personality. By introducing statistical analyzes and mathematical models, ergonomic parameters and conditions that improve psychological diagnostic processes based on information that a device can provide are validated more accurately. The characteristics studied in this work serve future needs to generate patterns of both deformations and tensions of an individual that serve to generate diagnoses preset automatically. Acknowledgments. This work was part of the research project “SINSAE v4 Sistemas Inteligentes de Soporte a la Educación Especial” which is part of the Research Group on Artificial Intelligence (GI-IATA) of the Universidad Politécnica Salesiana, Cuenca-Ecuador.

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References 1. Mendoza, D.: Consecuencias del maltrato psicológico en niñas de tres a seis años, Ecuador (2011) 2. Déleg Aucapiña, M.C., Cusco Quito, M.E., Saeteros Saeteros, F.I.: Causas y consecuencias de la violencia intrafamiliar en niños de segundo a séptimo de año de básica, unidad educativa comunitaria rumiñahui, Ecuador (2014) 3. Belloch, C.: Recursos tecnológicos para la evaluación psicoeducativa, España (2009) 4. Xandro, M.: Grafologia elemental, Barcelona (1994) 5. Zhiminaicela, Z., Damián, S.: La grafología criminalística, Ecuador (2014) 6. Colado, M.: Estudio de la ansiedad en pacientes con cáncer de laringe mediante test grafológico, España (2002) 7. Ruiz Villa, S.A., Olano Castellón, L.Y.: La grafología como herramienta en la selección de personal, México (2013) 8. Pop, M.M., Giurgiulescu, M.: The developing of emotional-formative competence of the future teachers, important factor in ensuring the future quality of education, Romania (2015) 9. Akbari, Y., Nouri, K., Sadri, J., Djeddi, C., Siddiq, I.: Wavelet-based gender detection on off-line handwritten documents using probabilistic finite state automata (2016) 10. Djamal, E.C., Darmawati, R., Ramdlan, S.N.: Application Image Processing to Predict Personality Based on Structure of Handwriting and Signature, Indonesia (2013) 11. Andrés, I.S., Tapia, C.A.: Tablero táctil para soporte de apoyo a la educación especial y en el diagnostico psicológico de niños con factores de riesgo, Ecuador (2016) 12. Aubin, V.I.: Búsqueda de parámetros identificatorios en trazos manuscritos, Argentina (2012) 13. Fundez-Zanuy, M.: Biometric applications related to human beings: There is life beyond Security, Zcech Republic (2012) 14. Vásquez, J.L., Travieso, C.M.: Off Line Writer Identification Based on Graph metric Parameters, Spain (2013) 15. Romero, J.L., López, E.M., Ortega, M.A., Río, O.: Revista Internacional de Métodos Numéricos para Cálculo y Diseño en Ingeniería, España (2016) 16. Kattan, P.I.: Matlab guide to finite elements, New York (2008) 17. Pang, W., Xie, X., Fan, P., Liu, J.: An adaptive collocation method and mesh refinement for solving non-smooth trajectory optimization problems. In: International Conference on Intelligent Human-Machine Systems and Cybernetics (2016)

Precise Placement of Precordial Electrodes with +/−0.5 cm Accuracy for Recording ECG in Self-operable Diagnostic Devices Kavita Shashank1, Sakire Arslan Ay2, Ankit Fulzele1,3, R.C. Ram1, Huan Hu2, and Subhanshu Gupta2(&) 1 Pandit JNM Medical College, Raipur 492009, India [email protected], [email protected], [email protected] 2 Washington State University, Pullman, WA 99163, USA {arsalanay,hhu,sgupta}@eecs.wsu.edu 3 Kalinga University, Raipur, India

Abstract. Acute and chronic syndromes account for *50% of the estimated 500,000 cardiovascular deaths annually in the United States and similarly in densely populated countries as India. More than 100 years after its invention, surface electrocardiogram introduced by William Einthoven is still the most common fundamental technique and the gold standard for diagnosis, prognosis, screening and evaluating heart disease for many clinical conditions. Progress in wearable diagnostic devices have made possible low-cost, convenient and 24  7 point-of-care healthcare; however, their use is still limited to clinical diagnostic measurements. The main gap is the electrode placement at the correct intended location to realize high sensitivity with accurate waveform reconstruction. To achieve a precision of less than 1cm placement accuracy in precordial electrodes placement and to obtain consistent intra- and inter-observer results for avoiding wrong diagnosis, an interactive image-processing software has been developed in this work. We aim to provide a self-operable solution for placing non-contact wearable sensors without any medical assistance and generate repeatable and reproducible interpretations to get the best results. Keywords: Remote diagnostic healthcare
24  7 point-of-care
Precordial electrocardiogram (ECG) lead placement
Human-computer interaction
Kinect sensor
RGB-D image

1 Introduction Increase in stress factors like heavy physical exertion and severe emotional stress in the past few decades have been identified as the primary trigger mechanism causing cardiovascular diseases with acute and coronary syndromes [1, 2]. These deaths cost the economy a staggering *18% of the GDP. The 12-lead surface electrocardiogram (hereby called as ECG) [3] involves measuring differential scalar quantities at the limbs and at well-defined positions over the human chest typically performed by a trained nurse/doctor. © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_55

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Conventional ECG measurement techniques shown in Fig. 1 involves a series of steps that disincentives a patient towards getting the right medical diagnosis at the right time. These steps include: scheduling appointments, time to transport, registration, patient preparation and measurement by a trained nurse/doctor which all add to the cost of basic healthcare and further, leading to underusing the ECG. For example, over one third of patients evaluated for angina pectoris in outpatient settings do not have an ECG Fig. 1. Conventional 12-lead ECG monitoring recorded [4]. Only one fourth of patients through in-person visits and patient preparation with ST-segment elevation myocardial using wet-gel electrode sensing. infarction transported to emergency rooms, have a prehospital ECG, with resulting delays in re-vascularization procedures [5]. In addition, errors in interpreting ECGs are common and may be increasing in frequency. Studies [6] have reported that correct lead positions with an error less than 1 cm was achieved by trained technicians only for 50% of the studied men and 20% of the studied women. The with worst-case placement errors were as high as 6 cm. It has been shown that displacements of the precordial electrodes located nearby the signal source have a greater influence on the ECG signal than shifts of the distal limb electrodes [7]. Although computerized diagnostic algorithms have become more accurate and have served as important adjuncts to the clinical interpretation of ECGs, measurements and diagnoses are not currently sufficiently accurate to be relied on in critical clinical environments without expert review. A number of websites feature ECGs for self-assessment and clinical instruction. ECG Wave-Maven [8] provides free access to more than 400 case studies of ECGs, with answers and multimedia adjuncts. A final issue is with the application of wet-electrodes requiring set-up assistance which consumes precious time of the trained clinician or resource (>10 min) not including the time to transport/register the patient. For patients, use of the wet-gel electrodes can cause skin irritation and rashes over prolonged use which discourages patients to seek ECG measurements periodically, and causes additional complications for infants and the elderly (Fig. 2). Non-contact/dry sensors eliminate these drawbacks with recent works [9] demonstrating high fidelity waveform reconstruction after post-processing. Existing systems however lack the knowledge of self-automating the measurement process which involves placement of the precordial electrodes at the right location by a trained nurse/doctor. It has been shown that the displacements of the precordial electrodes located nearby the signal source have a greater influence on the ECG signal than shifts of the distal limb electrodes [10, 11]. Precordial electrodes need time to shift to apply bandages, drains, and to undertake an echocardiographic study [12]. However, displacement of the ECG electrodes from determined ‘standard’ positions can arise also

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from mistakes of medical staff [10, 13, 14] as well as by patients at home who participate in ECG monitoring programs. A common mistake is placing V1 and V2 electrodes too high, in second or third intercostal space [15], which could result in superior misplacement of remaining precordial electrodes. Electrodes V5 and V6 are also placed frequently in the fifth intercostal space and not in the recommended parallel position to electrode V4 [16], which is usually not precisely positioned according to visual estimation of midclavicular line [17]. On the other hand, since differences in inter-individual human anatomies, the exact Fig. 2. (a). Proposed system implementation with the heart position in the thorax is input, processing and GUI layers combining optical and electrical sensed signals, (b) body metric point extrapolation never precisely known [18]. captured by Kinect (blue dots), and precordial lead place- Both factors, dependent and independent on medical staff, ment marks (red). can cause the change of the distance between the electrodes and source of the signal in the heart as well as the solid angle at which outline of ventricular mass is seen from the body surface [11]. Without correct signaling, correct diagnosis cannot be done. In this context, we aim to provide a self-operable solution for placing non-contact wearable sensors [1] without any medical assistance and generate repeatable and reproducible interpretations for achieving the best results. To achieve precision in precordial electrodes placement with accuracy error of less than 1 cm and to obtain consistent intra- and inter-observer results to avoid wrong diagnosis, an interactive image-processing software has been developed in this work. This software designates where non-contact sensors are to be placed on the body to get the best results in the vital signs monitoring process. The software will provide a captured view of the patient’s real image and will highlight where the sensors need to be placed on the patients’ body for best reading accuracy. It will automatically identify the misplaced sensors and guide the patient with interactive video to move the sensors to the precise locations. The developed system will thus require no ‘prepping’ or a dedicated medical resource and will be able to generate diagnostic quality measurement that is reproducible and repeatable eliminating human dependent errors.

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Section 2 describes the proposed methods and algorithmic framework to achieve precise real-time three-dimensional image capture with background rejection. A statistical method is proposed to validate the automatic precordial lead placement with the placements guided by trained nurse/doctors. Section 3 lists the results from the above analysis performed on healthy test subjects. Section 4 concludes this paper with the discussion and future work.

2 Methods 2.1

Image Detection with Background Rejection

The novel device proposes an autonomous self-assisted vital sign monitoring system which guides users to place the ECG sensors at precise locations on their torso for accurate ECG monitoring. The developed software system captures patients’ skeletal points from Microsoft Kinect V2 and calculates the estimated sensor locations on the patients’ body with respect to various skeletal points. We explored various alternative algorithms each utilizing a different set of skeletal points for sensor location calculation: The first algorithm is based on the two shoulder joints and the neck joint; the second uses the torso area and the shoulder joints; and the third algorithm is based on the intersection points of two diagonal lines: one from right shoulder joint to left hip joint and another from left shoulder joint to right hip joint. Our software implements a graphical user interface displaying the continuous RGB images of the patient with estimated sensor locations marked on the patient’s torso (highlighted with red squares). The software detects where the sensors are placed through image processing and ensure they are placed correctly at the marked locations. If adjustments are necessary (i.e., a sensor is dislocated) the user is notified. Each ECG sensor has a reflective marker attached to it, therefore the sensors appear as bright points in the RGB image. The image processing algorithm detects these bright points and guides the patient in real-time to move the ECG sensor placed on his/her body.

2.2

System Implementation

Figure 2(a) shows the proposed image processing system. The system stores skeletal point data of various people, along with sensor point data provided by a doctor, and chooses the closest physical match to a new user of the system when they stand in front of the Kinect. The algorithm that chooses the best match to a new subject uses the property of similar triangles rectangles, comparing the user’s biometrics to the stored data set. Each side of the triangle was given its own score relative to how closely it matches the user, then weighted based on how important that side of the triangle is. The reference data with the lowest score is the best fit for the current user. The algorithm for sensor placement is to stretch a reference image using the distance between the shoulders, and the distance between the shoulder points and the intersection point of two lines drawn from each shoulder to the opposite hip (Fig. 2(b)). The algorithm for sensor tracking is described below:

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1. LEDs are attached to the sensors to create an intense light. 2. EMGU [19] turns the RGB image from the Kinect into a grayscale image, and filters everything by its white value. The brightest objects are the only ones remaining. 3. For each circle of light in the EMGU feed, the center of the circle is found. This is the center of the placed sensor. 4. If the center of the placed sensor is within the boxes for where the sensors should be placed, the boxes change to green, indicating that the sensor is in the correct location. 5. Algorithm validation. To check the sensor prediction accuracy, we removed members of the project from the data pool. We then compared the predicted placement with the images we used as a reference as described further in Sect. 3. Level of agreement between the results was very pleasing with an average error of less than 1 cm, which is acceptable within the standard specifications (Fig. 3).

3 Results 3.1

Reference Database Generation

In this section, we compare the measurement accuracy from the proposed imaging technique through Kinect sensors to an established one, and found both methods having sufficient degree of agreement. According to many studies give the product-moment correlation coefficient (r) between the results of the two measurement methods as an indicator of agreement. Two measurements were made with one with automatic device and other with measured with experts to compare the accuracy of the proposed method. The correctness of the proposed algorithms relies highly on the accuracy of the skeletal point coordinates captured from the Kinect. In general, Kinect provides precise measurements for skeletal points. However, depending on the patient’s position with respect to the Kinect’s location (i.e., the height of the Kinect from the floor, the distance and angle of the patient to the Kinect), the error rate may increase. Our software analyzes the accuracy of the measurements and guides the user to adjust his/her posture until the skeletal shoulder points are aligned well with reference image. Reference points gets overlaid on the real image when co-ordinates aligned properly. Benchmark analysis for the accuracy of the proposed algorithms on healthy human subjects was performed. The reference images (database) are first generated by placing the sensors in precise locations on the captured image by three experts comprising of a physiologist, a physician and a cardiologist. Average of these three readings are considered as the golden reference shown in Fig. 4 from where the relative distance of the location of marks identified by the Kinect sensor is calculated in terms of angle measured

Fig. 3. Overlay of Kinect points on the sensor nodes. The red squares show the predicted locations from the Kinect sensor.

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from ‘X’ and ‘Y’ axis. Note that the accuracy of the proposed algorithm is assessed by relative measure from bony land marks only as there is no direct pinned measurement available. A total of 35 healthy subjects (8 female, 27 male) of different age, height and weight are considered. Written consent of subjects was taken with each subject undergoing the measurement Fig. 4. Algorithm validation by comparing Kinect more than 10 times at different results against observations by three experts compris- times to assess intra- and intering a team of physiologist, cardiologist and physician. observer accuracies. It was found that interoperable accuracy is of high significance with p-value < .0001, the calculated measurement error is not more than ±0.5 cm. Table 1 shows the measured coordinates for the six precordial electrodes on the torso. The measurements are taken in pixels with 1 cm = 37.7 pixels. Standardized positions for V1–V6 were identified by palpation and inspection, three sets of marks obtained in different colors by two experts compared against that made with Kinect sensor. The six male subjects were selected and examined sequentially as discussed Table 1. Precordial lead electrode position shown on torso for 6 subjects. The numbers shown are in pixels. (1 cm = 37.7 pixels) Subj #1 #2 #3 #1 #2 #3 #1 #2 #3 #1 #2 #3 #1 #2 #3 #1 #2 #3

XV1 15 22 20 10 20 20 25 30 22 22 21 20 10 15 28 11 10 12

XV2 22 6 5 35 30 30 20 35 20 15 20 12 30 30 29 22 24 20

XV3 40 35 29 52 60 52 35 45 46 32 50 45 50 50 55 40 40 40

XV4 60 60 48 78 100 100 60 55 75 55 68 70 75 82 77 60 64 60

XV5 90 86 81 108 130 132 90 98 110 82 102 104 102 110 110 90 92 90

YV1 50 55 65 45 40 45 35 45 45 54 50 48 50 57 65 35 40 42

YV2 50 55 65 60 45 45 35 45 35 54 50 52 50 52 56 35 45 40

YV3 70 65 85 79 62 60 55 50 50 73 120 103 80 86 85 45 55 55

YV4 85 85 95 78 90 90 65 85 85 92 98 50 75 75 78 63 80 75

YV5 85 85 96 78 100 75 65 95 85 92 100 75 75 90 92 60 80 82

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below with the measurement done in real time. Figure 4 and 5 shows the statistical analysis of the observed readings. Initially, two experts place reflective adhesive tape on the subject chest (white/pink colors). The same subject is then made to stand on a custom-made pedestal in front of the Kinect sensor and the electrodes are placed in positions highlighted with red circles (Fig. 4). The coordinate of the center of each circle is Fig. 5. Scatterplot showing residual error for V2 stored for further reference along with precordial-lead position estimation by the pro- their shoulder width and torso height posed algorithm, and the two experts after (identified through Kinect). The width, repeated observations. The Kinect measurement W, is calculated in pixels by the length of (#1 on x-axis) is within the 95% confidence level. the horizontal red line from the center of right shoulder joint to the center of left shoulder joint. The height, H, is measured using vertical red line passing through bony prominence of vertebral column in real-time 2D image of end user. These red marks were automatically adjusted by the designed algorithm for different body shapes using the scaling algorithm described in Sect. 2. Finally, another expert places a different color tape to cross-correlate with the previous three measurements. Three sets of markings with different colors for the six precordial electrodes (V1–V6) are thus obtained for each subject using the above procedure.

3.2

Accuracy of Thoracic Image Computation

Fig. 6. Mean variation of the coordinates of the six precordial electrodes. Reference 1 on the x-axis are marks measured through Kinect sensor whereas references 2 and 3 are measured by the two experts respectively for 27 subjects.

The reference database generated in the above step is then used to analyze the readings for 27 normal adult subjects from different age groups and body dimensions. Statistical significance of inter- and intra-electrode placement errors with multiple readings was estimated to observe repeatability of our software. A normal probabilityprobability plot of regression standardized residual was done which shows the measured samples following a normal distribution. Regression coefficients for the precordial frontal leads V1, V4 and V5 are 0.07, 0.187 and 0.187 pixels respectively with the correlation coefficients as 0.423, 0.673 and 0.673 pixels respectively indicating good strength in

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relationship reproducibility and high significance statistically. Table 1 shows the X- and Y-coordinates for 6 subjects for V1–V6 leads measured at different intervals. IBM SPSS Statistics 20 toolbox is used for data analysis. Line of equality is drawn and find out the high agreement between two methods (CI = 95%) as shown in Fig. 5. Figure 6 shows the mean variation in the placement of the electrodes for the above subjects with Kinect against of the observations by the experts. It can be stated that Kinect is able to accurately predict and repeat the measurements. The standardized correlation coefficient is further calculated. On x-axis, we consider the distance from mid-sternal line to center of marks on V1–V6 leads and on y-axis, the distance from midpoint of the line joining the two shoulder joints to center of marks from V1 to V6 is used. Standardized correlation coefficients for the x-coordinate of the V1–V6 marks are 0.676, 0.654, 0.627, 0.649, 0.549 and 0.645 respectively and is found to be higher in comparison to the y-coordinates for V1–V6. This is shown in Fig. 7. Standardized correlation coefficient for y-coordinates of V1–V6 marks are 0.387, 0.177, 0.416, 0.624, 0.633 and 0.662. Of these V1–V3 are definitely less significant than x-coordinate values. Both data sets signify

Fig. 7. (a)(b)(c)(d). Standardized correlation coefficients for x- and y-coordinate of V1, V4 and V6 for 35 subjects. The circles are observed values, whereas the center thick line is linear extrapolation and the thin line is a logarithmic limit.

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good association of width and height of torso and we can infer that it is more closely related to width of torso rather than height of torso. Statistical significance of inter- and intra-electrode placement errors with multiple readings was estimated to observe repeatability of our software.

4 Discussion and Future Works An image processing software system has been demonstrated using Microsoft Kinect RGB-D sensor which enables self-assisted sensor placement for 12-lead ECG. The proposed method achieves reliable and precise placement. The ease of use, lower installation costs, and higher positional accuracy makes this system suitable to be adopted in diagnostic settings in hospitals and medical clinics significantly reducing patient costs and also improving quality of diagnostic 12-lead ECG assessment. With database expansion and further research this can be acceptable as a standard procedure which can be used in other automatic bio-imaging devices. Future work will comprise of a custom-built system with LEDs on the ECG sensors along with ECG input support built into the into the program to enable sensor tagging as required. Recent advances in biomedical engineering and technology, clinical therapeutics, and basic science suggest that important new clinically relevant information may be derived from the ECG. Methods to estimate direct cardiac potentials from surface recordings will permit a more direct understanding of the abnormal physiology underlying electrocardiographic patterns, and extract “hidden information” in the ECG using advanced mathematical techniques expanding its clinical usefulness. Full application of the capabilities of computerized systems will permit the development of more accurate diagnostic criteria based on population subsets and clinical covariates. Continued research correlating electrocardiographic patterns with genomic and biomarker patterns will promote greater understanding of the variations in electrocardiographic patterns which are seen in common disorders. Also, the development of new treatments will likely expand the role of the ECG as urgent revascularization and cardiac resynchronization have done in the recent past. The historic richness of the surface ECG as a source of basic physiologic and clinical information continues to support the expectation of future unanticipated areas for exploration and discovery. Cardiac potentials are most commonly displayed as the classic scalar ECG. Scalar recordings depict the potentials recorded from each lead as a function of time. For standard electrocardiography, amplitudes are displayed on a scale of 1–10 mm on the vertical axis and time as 400 ms/cm on the horizontal scale. Leads are generally displayed in three groups, the three-standard limb leads followed by the three-augmented limb leads followed by the six precordial leads V1 to V6. With collaboration of experts from different streams, the proposed bio-imaging interactive device can optimize well-being and overall system performance as well as minimizing intra- and inter-operable human errors. Besides it is easy to adopt and provides resiliency to health-care system making it economical, and accessible to every person of the society.

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Acknowledgments. This research was funded by WSU Office of Research and by Chhattisgarh Government Department of Science and Technology, India.

References 1. Chi, Y.M., Cauwenberghs, G.: Wireless non-contact EEG/ECG electrodes for body sensor networks. In: IEEE International Conference on Body Sensor Networks (BSN), pp. 297–301 (2010) 2. Goldstein, S., Medendorp, S.V., Landis, J.R., et al.: Analysis of cardiac symptoms preceding cardiac arrest. Am. J. Cardiol. 58(13), 1195–1198 (1986) 3. Israel, S.A., Irvine, J.M., Cheng, A., et al.: ECG to identify individuals. Pattern Recogn. 38, 133–142 (2005) 4. Pokharel, Y., Spertus, J.A.:Assessing and improving the quality of care in cardiovascular medicine. In: Fuster, V., Harrington, R.A., Narula, J., Eapen, Z.J. (eds.) Hurst's The Heart, 14th edn. McGraw-HillHurst, New York 5. Li, J., Reaven, N.L., Funk, S.E., et al.: Frequency of electrocardiographic recordings in patients presenting with angina pectoris (from the Investigation of National Coronary Disease Identification). Am. J. Cardiol. 103(312), 312–315 (2009) 6. Diercks, D.B., Kontos, M.C., Chan, A.Y., et al.: Utilization and impact of pre-hospital electrocardiograms for patients with acute ST-segment elevation myocardial infarction. J. Am. Coll. Cardiol. 53(2), 161–166 (2009) 7. Kerwin, A.J., McLean, R., Tegelaar, H.: A method for the accurate placement of chest electrodes in the taking of serial electrocardiographic tracings. Can. Med. Assoc. J. 82, 258–261 (1960) 8. ECG Maven: http://ecg.bidmc.harvard.edu 9. Searle, A., Kirkup, L.: A direct comparison of wet, dry and insulating bioelectric recording electrodes. Physiol. Meas. 21, 271–283 (2000) 10. Ganeshan, R., Ludlam, C., Francis, D., et al.: Accuracy in ECG lead placement among technicians, nurses, general physicians and cardiologists. Int. J. Clin. Pract. 62(1), 65–70 (2008) 11. Oosterom, A.V., Hoekema, R., Uijen, G.J.: Geometrical factors affecting the interindividual variability of the ECG and the VCG. J. Electrocardiol. 33, 219–227 (2000) 12. Nelwan, S.P., Kors, J.A., Meij, S.H., et al.: Reconstruction of the 12-lead electrocardiogram from reduced lead sets. J. Electrocardiol. 37, 11–18 (2004) 13. Rudiger, A., Hellermann, J.P., Mukherjee, R., et al.: Electrocardiographic artifacts due to electrode misplacement and their frequency in different clinical settings. Am. J. Emerg. Med. 25(2), 174–178 (2007) 14. McCann, K., Holdgate, A., Mohammad, R., Waddington, A.: Accuracy of ECG electrode placement by emergency department clinicians. Emerg. Med. Australas. 19(5), 442–448 (2007) 15. Chan, P.G., Logue, M., Kligfield, P.: Effect of right bundle branch block on electrocardiographic amplitudes, including combined voltage criteria used for the detection of left ventricular hypertrophy. Ann. Noninvasive Electrocardiol. 11(3), 230–236 (2006) 16. Ang, D.S.C., Lang, C.C.: The prognostic value of the ECG in hypertension: where are we now? J. Hum. Hypertens. 22, 460–467 (2008)

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17. Okin, P.M., Devereux, R.B., Nieminen, M.S., et al.: Electrocardiographic strain pattern and prediction of new onset congestive heart failure in hypertensive patients: the Losartan intervention for endpoint reduction in hypertension (LIFE) study. Circulation 113, 67–73 (2006) 18. Hurst, J.W.: Switched precordial leads. Circulation 101(24), 2870–2871 (2000) 19. EMGU Software: http://www.emgu.com/wiki/index.php/Code_Reference

A Domotics Control Tool Based on MYO Devices and Neural Networks Santiago Luna-Romero, Paul Delgado-Espinoza, Fredy Rivera-Calle, ( ) and Luis Serpa-Andrade ✉ Universidad Politécnica Salesiana, Cuenca, Ecuador {slunar,pdelgadoe,frivera}@est.ups.edu.ec, [email protected]

Abstract. The automation of spaces has become a recurrent theme in current affairs due to the need to improve comfort, quality of life and facilitate work for the human being. Thus, this article proposes an intelligent system that allows controlling devices wirelessly in a domestic environment in a simple and safe way. Our system is based on the recognition of different gestures that user makes with his arm, using the bracelet MYO of the company Thalmic Labs. The bracelet consists of 8 electrodes, an accelerometer and a gyroscope. The implementation of the system is done through a wireless data collection classification module. The communication system is made up with ZigBee modules, which control the electrical and electronic devices in the home. In order to perform the recognizing and classification of electromyography (EMG) signals, an artificial neural network model based on supervised learning has used. This work specifies the procedure that we have followed to extract the characteristics of received signals, the training phase of learning system, and an explanation of used algorithms. Keywords: Domotics · MYO devices · Artificial neural networks · Wireless communication · EMG signals

1

Introduction

Home automation is a technology that in recent years has emerged in a significant way improving the quality of life of residential users in activities such as opening doors, windows, turning on/off the lights or also in the management of energy resources within the home. For example, nowadays is possible automatically controlling the gas and water consumption with the aim of reducing the environmental impact. Therefore, it is important mentioning that a smart home integrates a set of automa‐ tisms based on some technological pillars such: as energy management, electronics devices, computers, and robotics. All this with the aim improving the user’s comfort, saving energy, enhancing the security, and providing entertainment in the most effective way, and with a minimal or no intervention by the user side. In the following work is presented a wireless home automation system that allows the user to activate lights and open blinds inside a house using electroshography signals

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with a commercial device which has been adapted for said purpose, the advantages with respect to other systems Are presented in the multiple varieties of gestures that can be performed, so we can command several actuators that perform other activities in the home apart from those detailed in this paper. Another advantage of this system is the use of low-cost electronic elements. In [4] it is revealed that one of the greatest challenges of home automation when presenting the proposed applications due to the high cost of the components involved, this demonstrates the need to opt for devices that are econom‐ ically accessible. The document is divided into four sections, Sect. 1 provides information about the EMG signals, the characteristics and uses they may have, information is also presented on MYO bracelet, electrical characteristics and types of signals are presented in This section, in Sect. 2 we present the algorithm implemented for the recognition of the gestures, in Sect. 3 we give the evidence and the results obtained, Sect. 4 describes the conclusions and the future work.

2

State of the Art

They are biomedical signals that carry the information of the muscular activity of the human being, these signals carry information to and from the muscles towards the central nervous system. Therefore, because the objective of this project is to control a home automation system through different Movements performed with the upper extremities of the human being, it was found that the mioelectric signals are the ones that best characterize the selected movements, because after a treatment of signals in time and frequency, it is possible to extract essential characteristics that Allow the system to recognize these movements [1]. Myo is an electromyography (EMG) device that has the shape of a bracelet and is worn on the user’s arm, has 8 sensors (EMG) plus an accelerometer and a gyroscope. Myo Armband uses an ARM Cortex M4 processor that is in charge of performing the processing of these signals and for communication and it sent data this device does it through a Bluetooth interface version 4.0 [2, 3]. The set of these signals allows to determine which muscles are active and can link this information with activation patterns, the device has 5 factory preset gestures, however, to obtain a greater amount of gestures and therefore to perform more actions is Necessary the implementation of a recognition system which is presented in our work.

3

Extraction of Characteristics

This is the stage in which we want to find the most important information that allows a correct generalization and specialization when classifying movements, as well as rejecting noise as irrelevant data, thus producing a set of characteristics that reduces dimensionality of the pattern recognition problem. These extracted features should contain sufficient information. Considering the works [4–7] based on temporal and frequency analysis and spectral statistics, the characteristics to represent the myoelectric patterns were as follows:

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3.1 Features in the Domain of Time – Absolute Average Value – wavelength 3.2 Characteristics in the Domain of Spectrum (Wavelet) – – – –

4

Half spectrum. Unique values. Spectrum variance. Energy.

Artificial Neuronal Networks for Classification of Data

Neural networks arose in the mid-1980s and are based on a computational system inspired by the learning characteristics and structure of the biological neural network. Their basis is the artificial neuron, they possess characteristics of generalization and ability to learn from experience, without the need of a mathematical model, which makes them appropriate for EMG signals. A neural network consists of the following elements: Levels or layers of neurons, synaptic weights and activation functions [8, 9]. Artificial Neural Networks (RNA) (Fig. 1) perform with high precision the tasks of classification of patterns. The synaptic weights are updated dynamically by the learning algorithm in the training phase. In this work, we used the Neural Networks Feed Forward model with the levenberg marquardt algorithm, since this model has seen good results in tasks of recognition and classification of EMG signals in work [10–12].

Fig. 1. Neural network model.

ZigBee is a standard that defines a set of low-power, low-cost, low-range wireless transmission networks operating in the 868 MHz, 915 MHz and 2.4 GHz frequency bands. The ZigBee tree-based routing protocol enables reliable routing to Any

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destination address using a distributed routing scheme, each device can manage its address space [12, 14]. ZigBee-based networks contain three types of nodes, a coordinator, a router, and a final device. The coordinating elements within the network are responsible for config‐ uring network parameters and address assignments. Routers are responsible for extending network coverage and for creating additional routes. The final devices are usually powered by a battery and oversee performing some intended action, they are the last element of the network [12] (Fig. 2).

Fig. 2. ZigBee network (tree topology)

Per [12] home automation is one of the most commonly used ZigBee applications since it is easy to install the devices and the modification of the same between applica‐ tions can be detailed: service instrument reading, lighting control systems, Automatic irrigation systems, Tizona temperature control etc. For all this, this communication protocol is used in the development of the proposed system.

5

Descriptor Collection Methodologies

The proposed system consists of four stages: the collection of data corresponding to the electromyography signals, angular movement and linear movement of the test subjects, the extraction of characteristics of these signals, the creation of the neural network and the training of the same using Matlab and the real-time tests performed in C++ with the interaction of the modules arduino-xbee by serial communication. In this system, three types of signs were used to control the home automation envi‐ ronment, one that simulates turning on and off lights, another simulating the opening and closing of blinds, and another simulating the total blocking of a house. For this it was necessary that 10 chosen people arbitrarily make all the signs 5 times for a correct learning and a correct generalization of the network. For data collection, the “myo-sdk-win-0.9.0” library was used by Thalmic Labs to communicate the bracelet with a pc, and the algorithm was done in c++. The algorithm takes 60 samples of each electrode of the bracelet, as well as of each Cartesian axis of both the linear and the angular acceleration. These 60 samples corre‐ spond approximately to 3.5 s. In Fig. 3 we can see the flow diagram of this algorithm.

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Fig. 3. Flow chart in the data collection.

With the data obtained, and in order to reduce the problem’s dimentity, a summation of the values of the signals of all the electrodes was made to form a signal that depends on the values of 8 electrodes. The same was done for the angular and linear accelerometer signals. In this way, it was possible to obtain 3 new signals with a size of 60 samples, to each one of these new signals extracted the characteristics mentioned in the previous section, the block diagram of this process can be observed in Fig. 4.

Fig. 4. Block diagram in the extraction of characteristics.

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In this way, all buffers of 60 samples of all signals coming from the cuff would be converted into a total of 18 signals from one sample. With all the information collected, we proceeded to create the neural network in Matlab, using the nntraintool toolbox, with the following specifications: • 3 layers, one input, one output and one in the hidden layer, with activation functions for the hidden layer and output “tansig” • 18 neurons in the input layer, 8 neurons in the hidden layer, and 3 neurons in the output layer. • Algorithm of levenberg marquardt training. For the selection of neurons in the hidden layer we proceeded to perform several entrenamientos with different numbers of neurons, then observe the error curves of the training, and based on the concepts of generalization it was concluded that the neural network achieves its objectives with 8 neurons in the middle layer. The network archi‐ tecture can be visualized in Fig. 5.

Fig. 5. Architecture of the neural network used.

For its real-time operation, a sliding window was used to fill the data buffers, then perform the same process as in the previous section to pro-assign to the recognition and classification through the neural network. This algorithm is implemented in c++ with synaptic weights of the neural network imported from matlab, and for communication with the xbee modules, the serial port was used. The operating diagram of this system is observed in Fig. 6.

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Fig. 6. Real-time operation diagram

At the test stage, thirty attempts were made for each gesture among all test subjects, and the number of hits that were taken in total to check the efficiency of the system was checked. In Table 1 we can observe this process. Table 1. Success table of tests performed Gestures Gesture 1 Gesture 2 Gesture 3 Gesture 4 Gesture 5 Gesture 6

6

Number of hits 25 24 26 25 24 26

Percentage of hits 83.33% 80.00% 86.66% 83.33% 80.00% 86.66%

Conclusions and Future Works

With all the tests performed, it can be concluded that the system proposed in this paper reaches an efficiency of approximately 83.33% for the recognition and classification of electromyographic signals. In this work, we worked with a single signal that depends on all the electrodes of the arm, in the future we would test how this system works without joining all electromyography signals, but working with them all together.

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It is possible to observe that we are working with all the electrodes of the bracelet, for the next investigation it is proposed to analyze the energy of the electro-myiograph‐ ical signals in order to know if it is possible to create a bracelet with less electrodes and in turn of lower cost. The work in c++ being a low-level language was noticed the speed of response to mathematical computation, this should be maintained for future work or in turn make a comparison of speed with another language of high level. As future work is intended to create an application for the cell phone where the user is able to record new gestures and send orders wirelessly to the central device of the house, in addition to that configure the system so that it is possible to connect multiple bracelets so that all Users can access the system at the same time, the challenge to create an efficient system so that it can be used in any home.

References 1. Bustinza, M.S., Ccopa, L.P., Maldonado, D.A., Perca, E.C.: Adquisición, parametrización y clasificación de patrones de señales mioeléctricas para el control de movimiento de un exoesqueleto que asiste la bipedestación. IEEE (2016) 2. Silva, E.C., Clua, E.W., Montenegro, A.A.: Sensor data fusion for full arm tracking using Myo Armband and leap motion. In: 14th Brazilian Symposium on Computer Games and Digital Entertainment (SBGames), pp. 12–134 (2015) 3. Ploengpit, Y., Phienthrakul, T.: Rock-paper-scissors with Myo Armband pose detection. In: International Computer Science and Engineering Conference (ICSEC), pp. 1–5 (2016) 4. Villarejo, J.: Detección de la intención de movimiento durante la marcha a partir de señales electromiográficas (2011) 5. Betancourt, G., Suárez, E.G., Franco, J.F.: Reconocimiento de patrones de movimiento a partir de señales electromiográficas (2004) 6. Park, S.-H., Lee, S.-P.: EMG pattern recognition based on artificial intelligence techniques. IEEE Trans. Rehabil. Eng. 6, 400–405 (1998) 7. Mendoza, L.E., Peña, J., Muñoz-Bedoya, L.A., Velandia-Villamizar, H.J.: Procesamiento de señales provenientes del habla subvocal usando Wavelet Packet y Redes Neuronales. TecnoLógicas 655–667 (2013) 8. Chipana, M.A.: Clasificacion texturas mediante redes neuronales. Revista de Informacion, Tecnologia y Sociedad, p. 62 (2009) 9. Romo, H.A., Realpe, J.C., Jojoa, P.E.: Análisis de señales EMG superficiales y su aplicación en control de prótesis de mano. Avances en Sistemas e informatica, p. 4 (2007) 10. Frutos, D.T., Morales, N.R., Rodriguez, J.G., Zahira, J.F., Perez, L.R.: Clasificación de señales electromiograf\́ias mediante la configuración de una Red Neurona Artificial. CULCyT (2016) 11. Hargrove, L.J., Englehart, K., Hudgins, B.: A comparison of surface and intramuscular myoelectric signal classification. IEEE Trans. Biomed. Eng. 54, 847–853 (2007) 12. Englehart, K., Hudgins, B., Parker, P.A., Stevenson, M.: Classification of the myoelectric signal using time-frequency based representations. Med. Eng. Phys. 21, 431–438 (1999) 13. Leite, E., Várela, L., Pires, V.F., Cardoso, F.D., Pires, A.J., Martins, J.F.: A ZigBee wireless domotic system with Bluetooth interface. In: IECON 2014—40th Annual Conference of the IEEE Industrial Electronics Society, pp. 2506–2511 (2014) 14. Alliance, Z.: ZigBee Specification. http://www.zigbee.org/Standards/ZigBeeSmartEnergy/ Specification.aspx

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15. Wei, L., Zhang, S., Chen, L., Song, J., Wang, X., Yin, L., He, M.: Wireless temperature monitoring system based on FBG and Zigbee. In: 2016 15th International Conference on Optical Communications and Networks (ICOCN), pp. 1–3 (2016) 16. Rodríguez-Gracia, D., Piedra-Fernández, J.A., Iribarne, L.: Adaptive Domotic System in Green Buildings. In: 2015 IIAI 4th International Congress on Advanced Applied Informatics, pp. 593–598 (2015) 17. Nieto, J.O.: Prototipo de Sistema Domótico Habilitado Para Interacción Cerebro-Máquina (2013) 18. Lozada, M.A., la Rosa R.F.D.: Simulation platform for domotic systems. In: 2014 IEEE Colombian Conference on Communications and Computing (COLCOM), pp. 1–6 (2014) 19. Contreras, J.C., Campoverde, R.S., Hidalgo, J.C., Tapia, P.E.: Mobile applications using TCP/ IP-GSM protocols applied to domotic. In: 2015 XVI Workshop on Information Processing and Control (RPIC), pp. 1–4 (2015) 20. Choudhury, N., Matam, R., Deka, V.: Priority based ZigBee routing protocol for LR-WPAN. In: 2016 IEEE Students #8217, Technology Symposium (TechSym), pp. 19–201 (2016)

Biomimetical Arm Prosthesis: A New Proposal Daniel Proaño-Guevara, Javier Procel-Feijóo, Johnny Zhingre-Balcazar, ( ) and Luis Serpa-Andrade ✉ Grupo de Investigación en Ingeniería Biomédica GIIB-UPS, Universidad Politécnica Salesiana sede Cuenca, Cuenca, Ecuador {Dproanog,cprocelf,jzhingreb}@est.ups.edu.ec, [email protected]

Abstract. In Ecuador, as in the world the most commonly used prostheses are only aesthetic, and the problem with the people that uses them is that they don’t feel fully comfortable and independent with their activities, so in looking for solving this problem, researchers have designed different active prostheses but as the technology advances, these equipment gets more complex, heavy and expen‐ sive, so the people who need them doesn’t feel acceptance. The goal of this and the further investigations is development of a new design that can properly inte‐ grate the top technologies in a skeletal design which makes natural movements and will improve the quality of life of the people who uses it. This paper analyses the different designs on the available prosthesis and extract from them the best characteristics of the upper limb prostheses design. Keywords: Bionics · Powered prosthesis · Biomechanics · Transhumeral prosthesis

1

Introduction

The CONADIS (Consejo Nacional para la Igualdad de Discapacidades) of Ecuador registers that physical disabilities cover about 47% of total disabilities. Annually it is reported that there are about 117,889 people who have suffered trauma, where is a tendency in which young adults, generally male live this situation, being a pattern that is reflected worldwide [1]. Trans-humeral prosthesis offer help to people with amputations to redevelop daily activities (ADLs), improving their quality of life even allowing their reintegration into work [1, 2]. Emulating the level of functionality of the human hand has proved to be extremely complicated, from a mechanical perspective it is very difficult to integrate a large number of degrees of freedom and their corresponding actuators within a dimensioned structure for a purpose [3]. Roboticists have always sought inspiration in nature and have been intrigued by the most skillful and dexterous element of the human body: the hand [4]. The hand is considered one of the final actuators of greater complexity in the human body, and this gives its importance given the amount of degrees of freedom and conse‐ quent movements that can perform [3]. Following this information, the possibility of © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_57

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recovering the entire member would give the patient a multipurpose tool, which is not limited to the hand, but to a whole system that would not only allow the patient to perform specific activities but also to live his life with normality and possibly reinserted into a job. Developing prostheses should be compared to devices available on the market, unfortunately its architecture is not open source in terms of sensing, actuators and embedded systems, which considerably limits the ease of comparison and freedom of development on these systems [2]. Active prosthesis have been developed mainly on mechanical systems that provide functional movements, and few degrees of freedom, which are limited solely to reproducing movement, using systems such as planetary gears, or much more complex systems that are governed by a motor directly on the articulation since they are mechanically based on previously developed systems [2, 5, 6]. The devel‐ opment of an anthropomorphic and anatomically correct system based on musculoske‐ letal systems has proven to be a very complicated challenge, but once it is completed, it completely changes the range of movements and favors a greater acceptance of the patients that will use it, since, as they resemble a human hand, they feel more comfort‐ able with it and their movements are much more natural and those designs that can be used in other areas of biomechanics [3, 7]. Although the development of prosthesis has been concentrated mainly in hands, the development in transradial or transhumeral prosthesis is considerably smaller, so there is no extensive bibliography demonstrating the develop‐ ment of biomimetic systems that support these areas in the development of common active prosthesis. Estimates and comparisons with various systems are used to determine the speed and range of mobility of a joint [6, 8]. The state-of-the-art for robotic hands always strive to increase design simplicity without compromising efficiency in terms of grasping skills and positions that can take the hand and that same trend should have the other segments of the upper extremity, offering variety of efficient movements [4]. Over time, different forms have been developed to simulate the limbs, and move‐ ments that they perform, among them are the prosthesis activated by the body, which are anchors arranged in the patient’s stump that allow him to operate systems of grasping or flexion elbow extension, these systems are friendly to the environment, relatively inexpensive and offer some proprioception and feedback to the user about the force he is exerting [2, 5]. Since 1940 the engineers have focused on simulating the movements of a human arm using myoelectric prosthesis which unlike body-activated prostheses, do not require complex wiring and can operate at higher ranges of motion, allowing them to access a greater work area [2, 5, 9]. Developing a prosthesis based on an anthropomorphic skeletal system that simulates as many movements as necessary by a subject of productive age so that extra space is available for the placement of sensory elements (exteroception), so that it has more natural movements and in this way the patient can feel more identified with the device and can decrease the percentage of rejection to active upper limb prosthesis [3, 10]. A very important objective in the development of the prosthesis is that it should be as light as possible, cosmetically pleasing, comfortable for daily use and providing sufficient functions for ADLs [2, 6].

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Development (Design)

2.1 Anthropomorphism Currently the study of robots based on musculoskeletal systems is performed to explore the advantages of these systems have based on the biological design of the same and have evolved to achieve the ideal design to perform the functions expected of them [7]. So, it helps a lot in the consideration of the design and functions that the anthropomorphic prosthetic will perform. Hand. The main idea is to use the human hand as a reference of design in terms of functionality of movements and morphology, since in this way a completely bio-inspired and functional design can be realized. For a correct anthropometric design you must have a constant feedback from a physician who supervises the forms and methods used to develop the movements [4]. Wrist. The wrist has three degrees of freedom: pronation - supination, flexion - exten‐ sion and radial – ulnar deviation [2]. 2.2 Forms of Design Carried Out Ikemoto developed a robotic arm consisting of 7 DOFs driven by pneumatic muscles that seek to simulate the nature of human humerus and humerus movements, movements that are generally not considered for prosthesis development, and a radio junction was designed in the forearm formed by two bones, radius-ulna and the wrist that consists of an ellipsoidal coupling to achieve the natural movements [7]. The RIC arm has 5 DOF, 2 in the hand, 2 in the wrist and 1 in the elbow in addition that it is modular, which means that it can be used by people with transhumeral or transradial lesions and can also connect a prosthetic hand that the patient wants because it has a universal connection socket [6] system similar to the one made by Resnik that developed 3 prosthesis configurations: Radial Coupling (RC) for transradial amputations, Humeral Coupling (HC) for trans‐ humeral amputations and Shoulder Coupling (SC) for people with transhumeral ampu‐ tations with minimal or no residual limb [9]. 3D printed prostheses have been developed, which have 4 DOFs, that are controlled with surface electromyography (EMGs) and use servomotors for their movement [10]. It makes it very low cost, but the main problem with this type of prosthesis is that they are not strong enough to perform properly all the movements of daily activities. The forms of elbow movement proposed by Bennet [2] use planetary gears and a proportional differential system to reach different degrees of freedom. Foglia proposes that the study must be focused in the optimization of actuators to achieve all the necessary postures and thus develop a system of transmission by tendons being that the DEKA arm only offers flexion and extension with a system that looks for to minimize the dimensions and the weight of the actuators to achieve a better acceptance [11] it is corroborated by Kim showing that of the 7 DOFs that have the human arm, only 6 DOFs

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are necessary to perform the basic movements for wrist positioning and palm orientation [12]. Regarding the design of the wrist, it is important to take into consideration the degrees of freedom that it can perform, since in the development of daily activities these have a greater impact than the degrees of freedom present in the hand [2]. Some forms of handheld design studied occupy 5 independent actuators, wire guiding to control the fingers, and there are also results show that the 10 most important movements of the hand for different grip positions can be executed by three actuators and a differential system can be incorporated to develop more movements [4, 13]. Konnaris [3] proposes a hand of 24 degrees of freedom and pulley systems that were implemented in each joint of the fingers to avoid that the tendons move away of the central axis, minimizing the losses by movement, uses 7 motors to control 20 of the 34 degrees of freedom supporting with its 5 fingers a maximum of 2.3 kg. Tendon-based hands have the advantage of locating actuators away from the hand with relatively more torque but the relationships at finger joints are really complex and require a specific kinematic study for their functioning, so they use link systems, unions by blocks and springs that transmit movement to achieve the same effects as the tendons [14]. A recent clinical study showed that a hand with 22 DOF with a wrist of 1 DOF is functionally equivalent to a hand of 1 DOF and a wrist of 2 DOF when performing daily activities [6]. As for the movement of the fingers, Kontoudis [4] recommends using elastomeric materials to perform the digital extension while for flexion cables are used, attached to actuators suitable for this movement. To develop improvements in prosthesis functionality, researchers need to develop a prosthesis hardware structure to build and test virtual control, which can be very bene‐ ficial in early stages of development but this can’t replace physical tests [2]. As for the acquisition of signals, one of the main problems in myoelectric prosthesis is in the location and repositioning of electrodes and is something that could be solved by analyzing common distributions and configurations of electrodes and rethinking it to be more comfortable for the patient [15]. In practice, what most limits the use of EMG is the change of electrodes, variations of force, involuntary activation of muscles [16]. For an adequate control it is necessary to recognize the muscles that perform the different movements and to study the myographic signals and from here determine the mechanics and ranges of movement of an arm to achieve a more natural movement [17, 18]. 2.3 Design Features The simultaneous action of multiple degrees of freedom of the fingers of the human hand is fundamental and shows its importance from evolutionarily relevant behaviors such as the clamp action, to actions performed day by day. Since there are no clear guidelines for the anthropomorphic design of a robotic hand and especially the thumb, the current state-of-the-art does not contemplate the full versatility of thumb movement [3]. The hand design features found after reviewing previous designs are (1) the entire structure has a weight less than 500 g so the actuators do not see compromised its efficiency and

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there are no overexertion (2) Make a highly functional design that minimize the actuators needed to perform the movements and (3) focus on a mechanical design that allows to meet the points previously described [4]. Sekine proposes the use not only of motors and metal parts for the construction of the prosthesis but also the integration of different materials and systems in order to make the design of the prosthesis more suitable for daily use [19]. In fact, current prostheses should be designed to provide sufficient torque, velocity, and range of motion to develop the person’s daily activities (ADLs) [2] thus giving the patient independence of activities in his daily life. In order to determine the amount of degrees of freedom required, first, one must acquire information about a healthy arm and study the movements, in many cases systems such as the “CyberGlobe” are used, which show different variations of potential depending on the movement and this in conjunction with the myoelectric information offers a model and adequate data of the behavior of the arm [20]. The majority of developed prostheses manage the wrist rotation (pronation and supination) in a passive way, which forces the user of the prosthesis to place them in the position they think fit best to perform a job [2] [3]. The torque exerted by the elbow of the device must supply the exerted by the average of healthy subjects that is 5.8 Nm in flexion [2]. It should be noted that pronation/supination does not occur in carpal bones but in the forearm when the radius covers the ulna when overlapping. For a healthy wrist, the range of motion is 76°/85°, 75°/75° and 20°/45° for pronation/supination, flexion/extension, and radial-ulnar deviation [21]. At the development of the prosthesis, it is necessary to analyze the load applied to a degree of freedom and to see how much this affects its range of mobility and agility [2], to achieve a better result external rotor motors have proved to have a significantly better torque than the internal rotor motors [6]. For an information feedback on the behavior of the prosthesis, an adequate control of position and follow-up in the rehabilitation of the patient when it is being used, the use of IMU (inertial magnetic units) in different parts of the prosthesis is recommended [9, 22]. Complete control of artificial hands in an intuitive way remains an irresolute problem in the context of robotic teleoperation and prosthesis [3].

3

New Proposed Design

Despite the technological advances, it is estimated that between 50% and 60% of people with amputations do not use any type of prosthesis and this is due to the fact that current devices reach their skill increasing weight, size and complexity. Which results in the loss of robustness [13, 23, 24] also leads to the device falling into the uncanny valley which is the feeling of strangeness and non-belonging that a user feels when seeing the device, which effect could be reduced or eliminated with a suitable design of the pros‐ thesis [25]. The use of artificial hands with the same dexterity as a human hand is a challenge since the intentions of movement of the users do not always freely control the most

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advanced prostheses [16] or they must make uncomfortable movements to activate more movements due the limited availability of biometric signal sources [26]. There are no existing devices that offer pronation-supination movements in the market, but perform a twisting movement, without taking into consideration that the main function of a transhumeral prosthesis is to position or reposition the orientation of the hand to facilitate the grip or release of various objects, in several axes within a working environment instead of leaving a free and unnatural movement of wrist twist [2]. Since there are no clear guidelines for the anthropomorphic design of a robotic hand and especially the thumb, the state-of-the-art does not contemplate the full versatility of thumb movement. The replication of the natural kinematics of the thumb in artificial hands has only been performed by Konnaris [3]. The main forms of signal acquisition and device control are through electromyog‐ raphy and often used in conjunction with controls at the user’s feet to perform very specific functions [9]. There are a large number of research prototypes in academia and very few commer‐ cial ones, this is due to the acceptance of the patients towards the devices, however it is necessary to create a comparison between the different prostheses and evaluate their anthropomorphism and thus to be sure of the acceptance of the device [27]. Konnaris established an interdisciplinary precedent in the field of biorobotics, quan‐ tifying the dexterity and anthropomorphism of its design with respect to human, pros‐ thetic and robotic hands [3]. The proposal is to design a prosthesis that copies the skeletal anatomy of the human arm as shown in Fig. 1. Where will be analyzed the different Degrees of Freedom that the person need to develop ADLs with fluency and dexterity, also considering the design goals analyzed before such as low weight and easy control, contributing to a robust design to be presented to a patient and a further clinical introduction.

Fig. 1. Comparison between the new proposed design and the traditional design of the prostheses, showing advantages and improvements in the design. The imaged presented in “Traditional Design” belongs to Lenzi [6].

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One of the most important design goals is to select the number and localization of active DOF in the design of a prosthetic arm is critical to find the perfect balance between dexterity and weight, thus improving the clinical benefit [6]. Recent research has debated whether enhancing prosthetic wrist serves better amputees than a highly skilled hand [21]. The main characteristics of the new proposed prosthesis design are that it should have an anatomic design, and based in anthropometric measures of the patient as shown in Fig. 2. The prosthesis should adapt to the needs of the patient offering only the degrees of freedom he need to develop the ADLs controlling it with biometric signals that could be obtained from the remaining muscles or a mix of them with the brachial plexus, in further studies we could obtain the signals from EEG.

Fig. 2. The following diagram shows the integral parts that conform the new prosthesis proposal, where is highlighted the anatomic mimetic importance and the patient comfort.

4

Conclusions and Future Works

All amputation is a great challenge, but when they are above the elbow they become even more complicated, since it requires not only replacing the functional part of the elbow but also the hand. So, the transhumeral prosthesis proves to be a great design challenge, but at the same time it will be possible to make the person perform practically natural movements. A very important part of the design is the hand because it is not only a prehensile organ, but also is responsible for performing many activities such as writing, catching an object, identifying things and doing many daily activities, so that their study is an

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important part of the research. Achieving the delicacy of holding a pencil or holding an egg or tightening an object tightly is one of the biggest challenges that can be achieved. To achieve a better acceptation of the patients of the arm prostheses the design looks for an ergonomic, light, and easy to control design that serves the user for all the daily activities with the strength required to perform them, but also the prostheses should be an integral part of the person, and should be recognized as a part of them, and the way to achieve it is to make them the most similar to the human anatomy, not only cosmet‐ ically but in a functional way. Basing in a musculoskeletal design of the arm, the half of the designing work is done, because the nature has improved the arm design to be useful in all the activi‐ ties that requires repositioning the ubication and rotation of the hand so it can be used as a tool. Also, the whole mechanical distribution of forces is changed protecting the actuators from suffering direct impacts, and with this design the actuators over a DOF could be more than one, maybe a small group could control the fine motor and when strength is required other actuators, stronger but slower could act to develop the activity with property. This kind of design will free a lot of space specially on the hand where sensors could be installed so the patient could ‘recover’ their senses with the prostheses and have exterior information that could prevent injuries to the patient and also the equipment, this, applied with a correct automatic control could help the patients to develop almost every daily activity with normality, and this will represent an acceptation of the equip‐ ment, an improvement in the quality of life of the user and a possible job reinsertion which offers independence of the patient. This paper should work as a basis for the future design of upper limb prostheses including mechanics, signal acquisition and processing for an adequate and easy control of the equipment. Acknowledgements. This research was supported by the Biomedical Engineering Investigation Group (GIIB for its acronym in Spanish) and the teachers of Electronic Engineering of the Salesian Polytechnic University who provided insight and expertise that greatly assisted the research, although they may not agree with all the interpretations of this paper. We thank Belen Carrera, medicine student, for assistance with the anatomic knowledge of the human body which lead us to the development of this new proposal. We would also like to show our gratitude to Leonardo Bueno for sharing his pearls of wisdom with us during the course of this research, and we thank to all our classmates for their ideas that helped us developing this paper in a proper way. We are also immensely grateful to Walter Orozco, PhD. And Ítalo Mogrovejo for their comments on an earlier version of the manuscript, although any errors are our own and should not tarnish the reputations of these esteemed persons. This document, together with its application, gives us the opportunity to help other people to go ahead, overcome their physical limitations and regain their confidence in themselves. Engineering gives us the opportunity to learn many things and to engineer others, so engineering students or engineers have the obligation to look for solutions and help our society to get ahead.

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References 1. Conadis: Información Estadística de Personas con Discapacidad. http://www.consejodi scapacidades.gob.ec/estadistica/index.html 2. Bennett, D.A., Mitchell, J.E., Truex, D., Goldfarb, M.: Design of a myoelectric transhumeral prosthesis. IEEE/ASME Trans. Mechatron. 21, 1868–1879 (2016) 3. Konnaris, C., Gavriel, C., Thomik, A.A.C., Aldo Faisal, A.: EthoHand: a dexterous robotic hand with ball-joint thumb enables complex in-hand object manipulation. In: Proc. IEEE RAS EMBS International Conference on Biomedical Robotics and Biomechatronics 2016, pp. 1154–1159, July 2016 4. Kontoudis, G.P., Liarokapis, M.V., Zisimatos, A.G., Mavrogiannis, C.I., Kyriakopoulos, K.J.: Open-source, anthropomorphic, underactuated robot hands with a selectively lockable differential mechanism: Towards affordable prostheses. In: IEEE International Conference on Intelligent Robots and Systems 2015, pp. 5857–5862, December 2015 5. Bennett, D.A., Mitchell, J., Goldfarb, M.: Design and characterization of a powered elbow prosthesis. In: Proceedings of the Annual International Conference IEEE Engineering in Medicine and Biology Society, EMBS 2015, pp. 2458–2461, November 2015 6. Lenzi, T., Lipsey, J., Sensinger, J.: The RIC arm - a small, anthropomorphic transhumeral prosthesis. IEEE/ASME Trans. Mechatron. 4435, 1 (2016) 7. Ikemoto, S., Kannou, F., Hosoda, K.: Humanlike shoulder complex for musculoskeletal robot arms. In: IEEE International Conference on Intelligent Robots and Systems, pp. 4892–4897 (2012) 8. Jacobsen, S.C., Knutti, D.F., Johnson, R.T., Sears, H.H.: Development of the Utah Artificial Arm. In: IEEE Transactions on Biomedical Engineering, BME-29, pp. 249–269 (1982) 9. Resnik, L., Klinger, S.L., Etter, K.: The DEKA Arm: its features, functionality, and evolution during the Veterans Affairs Study to optimize the DEKA Arm. Prosthet. Orthot. Int. 38, 492– 504 (2014) 10. Sittiwanchai, T., Nakayama, I., Inoue, S., Kobayashi, J.: Transhumeral prosthesis prototype with 3D printing and sEMG-based elbow joint control method. In: International Conference on Advanced Intelligent Mechatronics and Systems, ICAMechS, pp. 227–231 (2014) 11. Foglia, M., Valori, M.: A high performance wire device for an elbow prosthesis. In: Proceedings of the IEEE RAS EMBS International Conference on Biomedical Robotics and Biomechatronics, pp. 494–499 (2012) 12. Kim, H., Miller, L.M., Byl, N., Abrams, G.M., Rosen, J.: Redundancy resolution of the human arm and an upper limb exoskeleton. IEEE Trans. Biomed. Eng. 59, 1770–1779 (2012) 13. Montagnani, F., Controzzi, M., Cipriani, C.: Is it finger or wrist dexterity that is missing in current hand prostheses? IEEE Trans. Neural Syst. Rehabil. Eng. 23, 600–609 (2015) 14. Omarkulov, N., Telegenov, K., Zeinullin, M., Begalinova, A., Shintemirov, A.: Design and analysis of an underactuated anthropomorphic finger for upper limb prosthetics. In: Proceedings of the Annual International Conference of the IEEE Engineering in Medicine and Biology Society, EMBS 2015, pp. 2474–2477, November 2015 15. Young, A.J., Hargrove, L.J., Kuiken, T.A.: Improving myoelectric pattern recognition robustness to electrode shift by changing interelectrode distance and electrode configuration. IEEE Trans. Biomed. Eng. 59, 645–652 (2012) 16. Yang, D., Yang, W., Huang, Q., Liu, H.: Classification of multiple finger motions during dynamic upper limb movements. IEEE J. Biomed. Heal. Informatics 21, 134–141 (2015) 17. Gao, Y., Bai, J., Wang, S., Zhao, J.: An elbow-biomechanical modeling based on sEMG. In: Proceedings of the World Congress on Intelligent Control and Automation 2015, pp. 5238– 5243, March 2015

558

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18. Lamperti, C., Zanchettin, A.M., Rocco, P.: A redundancy resolution method for an anthropomorphic dual-arm manipulator based on a musculoskeletal criterion. In: IEEE International Conference on Intelligent Robots and Systems 2015, pp. 1846–1851, December 2015 19. Sekine, M., Sugimori, K., Tarvainen, T.V.J., Yu, W.: Actuator for Shoulder Prostheses, pp. 1391–1396 (2012) 20. Sun, B., Xiong, C., Chen, W., Zhang, Q., Mao, L., Zhang, Q.: A novel design method of anthropomorphic prosthetic hands for reproducing human hand grasping. In: Conference proceedings: Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 2014, pp. 6215–6221 (2014) 21. Bajaj, N.M., Spiers, A.J., Dollar, A.M.: State of the art in prosthetic wrists: commercial and research devices. In: IEEE International Conference on Rehabilitation Robotics 2015, pp. 331–338, September 2015 22. Meng, D., Shoepe, T., Vejarano, G.: Accuracy improvement on the measurement of human joint angles. IEEE J. Biomed. Heal. Informatics. 2194, 1 (2015) 23. Lenzi, T., Lipsey, J., Sensinger, J.W.: Design of a small, anthropomorphic transhumeral prosthetic arm. IEEE Trans. Mechatronics 10(11), 2660–2671 (2016) 24. Smit, G., Plettenburg, D.H., Van Der Helm, F.C.T.: The lightweight Delft Cylinder hand: First multi-articulating hand that meets the basic user requirements. IEEE Trans. Neural Syst. Rehabil. Eng. 23, 431–440 (2015) 25. Mori, M., MacDorman, K.F., Kageki, N.: The uncanny valley. IEEE Robot. Autom. Mag. 19, 98–100 (2012) 26. Chen, W., Xiong, C., Yue, S.: Mechanical implementation of kinematic synergy for continual grasping generation of anthropomorphic hand. IEEE/ASME Trans. Mechatron. 20, 1249– 1263 (2014) 27. Kakoty, N.M., Hazarika, S.M.: A biomimetic similarity index for prosthetic hands. In: Proceedings of the 2013 IEEE Symposium on Computational Intelligence in Rehabilitation and Assistive Technologies, CIRAT 2013–2013 IEEE Symposium Series on Computational Intelligence, SSCI 2013, pp. 32–39 (2013)

Design of an Intelligent System for Prediction and Simulation of Writing in Children with Spasticity Luis Serpa-Andrade1,2(&), Luis González-Delgado1, Ana Parra-Astudillo1, Isaac Ojeda-Zamalloa1, Vladimir Robles-Bykbaev1, and Roman Bunay3 1 GI-IATA, Cátedra UNESCO Tecnologías de Apoyo para la Inclusión Educativa, Universidad Politécnica Salesiana, Cuenca, Ecuador {lserpa,lgonzalez,vrobles}@ups.edu.ec, {aparraa,iojeda}@est.ups.edu.ec 2 Maestría en Métodos Matemáticos y Simulación Numérica en Ingeniería, Universidad Politécnica Salesiana, Cuenca, Ecuador 3 Facultad de Psicología, Universidad Estatal de Cuenca, Cuenca, Ecuador [email protected]

Abstract. Spasticity is considered a wide spectrum disease that affects all age groups. However, the spasticity in children can have diverse causes, and commonly is present in those patients that have been diagnosed with Infantile Cerebral Palsy. Approximately two thirds of children with ICP present spasticity. On the other hand, traditional writing is a process related with children’s cognitive development, and allows creating new neural connections between hands, elbows and shoulders. For those reasons, in this paper we present a proposal that aims predicting writing in children with spasticity, with the objective of supporting the traditional writing learning process. Keywords: Intelligent prediction


Spasticity
Graphology descriptors

1 Introduction According to the Association of Neurological Surgeons (AANS)3, spasticity affects about 12 million people worldwide. In Ecuador, per the national information system of the “National Secretariat of Planning and Development”4, there are about 34,314 people with physical and motor disabilities. It is therefore important to mention that a high percentage of these people have limited quality of life in various aspects. In the educational field, people with physical and motor disabilities present serious difficulties to develop learning activities, where one of the most complex is the learning of writing. For this reason, it is fundamental to look for alternatives to support the area of language therapy, so that these people can communicate and develop various skills, such as writing, to improve other skills related to cognition. Writing in children is fundamental because it improves reading and in general their learning, it also contributes to the development of children’s communication with their environment and their development [1]. © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_58

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The proposal of an intelligent prediction and simulation system for writing in children with spasticity will be evaluated in the field research and laboratory tests aspect, constituting a new proposal based on the management of graphological descriptors for support in Language therapy. It is intended with this proposal to support language therapists in the graphological interpretation of children’s writing and thereby encourage learning. In the same way, it is also sought, support at home therapies as reinforcement performed by parents of children with motor spasticity. Spasticity refers to the abnormal increase in muscle tone characterized by speed-dependent hyperexcitability of spinal stretching reflexes, a symptom associated with upper motor neuron disorders manifested as tense or rigid muscles, interferes with activities of daily living and often causes pain and insomnia. It can also complicate daily hygiene, mobility, personal expectations, interpersonal relationships and has negative consequences for quality of life [2, 3]. The condition can be assessed by clinical scales, such as the Modified Ashworth Scale (MAS) or the Tardieu scale [4, 5]. Its natural evolution is towards chronicity, accompanied by static phenomena due to alterations in the properties of soft tissues (elasticity, plasticity and viscosity). When these properties are altered, fibrosis of the muscle and adjacent structures is established, the contracture becomes fixed, there are retractions and osteoarticular deformities and pain [6]. It is necessary to give the option of improving the quality of life so that multidisciplinary therapy plans are generated, the spastic patient being the center of the system is working with neuropediatricians, neurosurgeons, psychologists, physical and occupational rehabilitation teams. However, it is important to indicate that the main factor is always the accompaniment of the family or caregivers (Fig. 1).

Fig. 1. Multidisciplinary treatment for spasticity [6].

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The methodology of descriptor analysis is studied in several areas and constitutes an important support tool to develop several tasks. In the case of study of this work, this methodology will be applied around language therapy, specifically in analysis of graphological traits for the support in the prediction and simulation of writing. With this, it is sought to improve writing in children with motor spasticity through a computational tool. To optimize the result, the descriptors must go through a process of normalization, quantification and statistical analysis to be able to model this information and propose it as a mathematical equation.

2 Related Work Spasticity is the hardening or involuntary contraction of muscles that commonly occurs in people with spinal cord injuries. Spasticity is characterized by involuntary movements due to injuries to the central nervous system, is considered as a motor disorder due to increased speed and inability to stretch reflex creating imbalance and increasing spasms. Approximately 65% to 78% of the spinal cord injured population has spasticity, which is more common in cervical (neck) lesions than in thoracic (chest) and lower back [7]. On the other hand, a high percentage (80%) of children with Cerebral Palsy also present spasticity [8]. The severity of spasticity and symptoms vary from person to person and may include [9]: Sudden and involuntary flexion (stretching) of a limb or jerks in the larger muscle groups such as the trunk (chest, back and abdomen), the bladder, or the rectum. Hyperactive reflexes (supra active) such as muscle spasms when someone touches them lightly. Muscles stiff or stiff at rest, making it difficult to relax or stretch muscles. Muscle tension during activity, making it difficult to control movement. In writing, due to the lack of motor activity, a change of speed and shape of strokes, size compensation and in general in the mechanical characteristics, in the linguistic aspects with respect to the order and the structure of the elements inside of a sentence to define a message [10]. All spasticity needs treatment; however, the efficiency of therapies is usually temporary [11]. There are various rehabilitation techniques for spasticity, such as: Water therapy in which patients experience a deep relaxation of mind and body, freedom in water [12]. With acupuncture to improve the motor function of the affected limb as well as passive resistance to stretching, substantial statistical improvement is achieved by studying the Ashworth scale and the Barthes index [13]. Application of pharmacology, botulinic toxin Botulinic type A for the reduction of spasticity [14–16]. In rehabilitation, a multidisciplinary group intervenes towards a common goal, for which a plan of therapy and follow-up is proposed in each one of the areas, whether physical, oral or written, analyzing for this neural connectivity, action and Perception of movement [17, 18].

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3 Descriptor Collection Methodologies The Data mining can be used to treat descriptors characteristic of pathologies such as machine learning and decision trees [19]. There are works related to the prediction of human behavior through writing such as that presented by Champa [20], in which neural networks are used as a tool to process the data obtained from the writing analysis by [21] develops a similar work, obtaining 94% of the paper’s baseline inclination, the spherical pressure and the thickness of the strokes. Accuracy with the psychological profile using vector support machines as a processing tool. On the other hand, Iwayaa presents a work for writing recognition based on “PDA technology and some cell with character recognition” presenting a hybrid proposal that characterizes writing with 91.4% use neural networks and thus are able to generate an image prediction of writing and writing strokes [22, 23]. In language therapy, multimedia tools are commonly used, however, it is not possible to obtain descriptors from them. Therefore, the goal of these tools is to involve all academic staff and the parents of the patient. There is also language therapy based on pictograms or phrases associated with characteristic drawings easy to identify to generate a phrase, more used as a transmitter of needs [24]. A therapeutic robotic modality is developed by Meneses, this allows to obtain information on the position velocity and force of the movement to evaluate the evolution of the movement of the patient [25]. On the other hand, authors such as Flores generate therapies, but from input stimuli where tools are obtained that can start from the study of electromyography signals for their processing and computational understanding, an interface is used as an interface Computer or Tablet, pattern recognition, choice of pictograms, facial recognition [26]. There are many more digital tools that are not very useful to promote the autonomy of the person, learning other therapies such as therapies that only last a short time in the case of wave treatment, this method lasts only two months in the reduction of spasticity, a treatment called rESWT (shock waves) [27, 28]. As shown in Fig. 2, a method is proposed to support language therapists to achieve the goals proposed in the teaching of writing in children with motor spasticity, using the method of analysis, exploration and deduction around the following items: • Analysis of graphological descriptor recognition techniques. • Exploration of language therapy methodologies for the prediction of writing in children with spasticity. • Construction of a corpus of real cases obtaining descriptors for speech therapy. • Implementation of a computer application to measure the level of effectiveness of the methodology proposed for therapy.

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Fig. 2. Proposed intelligent system

4 Mathematical Proposed Approach In general, the spasticity affects the fine motor skills of children with Infantile Cerebral Palsy (ICP) and related disorders. Therefore, we propose an approach that relies on a mathematical model and a machine learning process (Fig. 3).

Fig. 3. General architecture of proposed approach.

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In our proposal, the object of study is the pen dynamics (during the different writing stages). This study is done under orthogonal transformation model and fixed-point and reference-point transformations which will be used as parameters in relation to data provided by a gyroscope installed on the pen. Below we define the boundary conditions for the model: • The vectorial analysis is intrinsic, that is, the operations that were applied to the vectors do not depend on the chosen reference system. • Operations and properties are invariant of the system, that is to say, they are invariant to rotations and translations. Firstly, we have defined an initial system O = (x, y, z). Given the tuple (i, j, k) as shown in Fig. 4, the model uses matrix rotation to establish the reference of a rotated system O′ = (x, y, z) and thereby obtain the angles according to hand movement as follows: 2

3 2 i0 a1 i 4 j0 5 ¼ 4 b1 i c1 i k0

3 a2 j a3 k b2 j b3 k 5 c2 j c3 k

ð1Þ

Where a1, a2, a3 are the directional cosines of the versor i′ with respect to the third, i, j, k. The coefficients a1, b1, c1 are the directing cosines of the versor i with respect to the tuple i′, j, k′ as indicated below: 2 3 2 0 i a1 i 4 j 5 ¼ 4 a2 i 0 a3 i 0 k

b1 j0 b2 j0 b3 j0

3 c1 k 0 c2 k 0 5 c3 k 0

ð2Þ

The directing cosines are established as i0 ¼ cosð;Þi þ sinð;Þj y j0 ¼  sinð;Þi þ cosð;Þj and serve to define a rotation, since they relate the angle to a versor determining new angles or instant angles.

Fig. 4. Initial system O in which is defined the tuple (i, j, k).

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The previous system is validated using a mixed product which must give one and is: 2

i0x 0 0 0 0 0 4 ði j k Þ ¼ ði x j Þ  k ¼ j0x kx0

i0y j0y ky0

3 i0z j0z 5 ¼ 1 kx0

ð3Þ

To find the positions corresponding to the pencil we have used the system that as described above (as an alternative method to the calculation of integral double from acceleration). Therefore, it is possible to obtain the velocity and the position of the pencil using a vector formed by the previously obtained verses (as coefficients) and x, y, z as unknown variables: OP ¼ x0 i0 þ y0 j0 þ z0 k0

ð4Þ

Then, by replacing the value of i′, j′, k′, we obtain: OP ¼ xða1 i0 þ a2 j0 þ a3 z0 Þ þ yðb1 i0 þ b2 j0 þ b3 k0 Þ þ zðc1 i0 þ c2 j0 þ c3 k 0 Þ

ð5Þ

Then, if we reorder the previous equation we obtain: OP ¼ ðxa1 þ yb1 þ zc1 Þi0 þ ðxa2 þ yb2 þ zc2 Þ j0 þ ðxa3 þ yb3 þ zc3 Þk 0

ð6Þ

So that the above vector is in the form of OP ¼ x0 i0 þ y0 j0 þ z0 k0 and it follows that: a1 x x0 y0 ¼ b 1 x c1 x z0

a2 y b2 y c2 y

a3 z b3 z c3 z

ð7Þ

And similarly, we have proceeded in the same way to find the previous or original positions according to the current or last ones indicated in the writing system as follows: x a1 x 0 y ¼ a2 x 0 z a3 x 0

b1 y0 b2 y0 b3 y0

c1 z 0 c2 z 0 c3 z 0

ð8Þ

Now if OP ¼ a ¼ axi þ ay j þ az k, replacing the coefficients that are the components of the vector, we get: a0x ¼/1 ax þ /2 ay þ /3 az

ð9Þ

a0y ¼ b1 ax þ b2 ay þ b3 az

ð10Þ

a0z ¼ c1 ax þ c2 ay þ c3 az

ð11Þ

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Or: ax ¼/1 ax0 þ /2 ay0 þ /3 az0

ð12Þ

ay ¼ b1 ax0 þ b2 ay0 þ b3 az0

ð13Þ

az ¼ c 1 ax 0 þ c 2 ay 0 þ c 3 az 0

ð14Þ

In this way, the vector (pen) is defined by its components and when it is rotated, these components are related by the previous expressions.

5 Conclusion The study center is the support for therapists to achieve the educational inclusion of people with motor disabilities and who have spasticity, for which we have as inputs in the proposal, the therapies that are executed by the specialists, contributing with variables for the recognition of Graphical characters, character addresses, character shapes, plotting speed and system training to get a model that represents this script. As future work, it is proposed to link all variables obtained and present an equation as a mathematical model to represent the form of writing and not treat regular writing in a format that is not accessible by the spasticity of patients. Acknowledgments. This work was part of the research project “SINSAE v4 Sistemas Inteligentes de Soporte a la Educación Especial” which is part of the research group on artificial intelligence and GI-IATA assistance technologies of the Salesian Polytechnic University Cuenca-Ecuador.

References 1. Kim, Y., Puranik, C., Otaiba, S.: Developmental trajectories of writing skills in first grade: examining the effects of SES and language and/or speech impairments. Elem. Sch. J., 593–613 (2015) 2. Rozina, H., Peden-McAlpine, C., et al.: Spasticity over time during acute rehabilitation: a study of patient and clinician scores. Appl. Nurs. Res., 16–23 (2016) 3. Dokyng, L., Jongmin, S., Jung, W., Tae-Beom, A.: Spasticity secondary to isolated involvement of the pyramidal tract. J. Neurol. Sci., 130–131 (2016) 4. Campenhout, A., Bar-On, L., et al.: Can we unmask features of spasticity during gait in children with cerebral palsy by increasing their walking velocity. Gait Posture 39, 953–957 (2014) 5. Rodriguez Mutuberria, L., Serravaldex, Y., et al.: La espasticidad como secuela de la enfermedad cerebrovascular. Resita Cubana Med. 43, 2–3 (2004) 6. Vivancos-Matekkabi, F., Pascual-Pascual, S., Nardi-Vilardaga, J.: Guía del tratamiento inytegral de la espasticidad. Rev. Neurol., 365–375 (2007)

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7. Reyes, M., Chiodo, A., et al.: La espasticidad y las lesiones de la médula espinal. Model Syst. Knowl. Transl. Cent., 1–5 (2011) 8. Monica, M., Lillo, S.S.: Impacto de las nuevas terapias en el manjo de la hipertonía en el niño con parálisis cerebral. Reista Médica Clínica Las Condes 2(25), 315–329 (2014) 9. Tapias, G., García-Romero, M., et al.: Análisis de minimización de costes del tratameinto de la espasticidad en niños con parálisis cerebral con toxina botulínica tipo A: un estudio observacional, longitudinal retrospectivo. Farmacia Hospitalaria, 412–426 (2016) 10. Rodriguez, J., Baquero, S., et al.: Escritura en enfermedad de parkinson (EP): revisión sistemática de literatura. Acta Colomb. Psicología, 17–26 (2011) 11. Garcia Diez, D.: Fisioterapia de la espasticidad: técnicas y métodos. Fisioterapia, 25–35 (2004) 12. Hidalgo Vaca, K.: Beneficios del watsu unido al tratameinto convencional de rehabilitación que reciben los niños y niñas de 2 a 6 años con PC en el centro de rehabilitación “San Miguel” de la provincia de Cotopaxi. Repositorio Universidad Técnica de Ambato, Ambato (2006) 13. Rodriguez-Mansilla, J., Espejo-Antúnez, L., Bustamante-Lopez, A.: Eficienca de la acupuntura en la espasticidad del paciente que ha padecido un ictus. Atencion Primaria, 226–234 (2016) 14. Kuhlen, M., Hoell, J., et al. Effective treatment of spasticity using dronavinol in pediatric palliative care. Eur. J. Pediatr. Neurol., 1–6 (2016) 15. Santamato, A., Micello, M., Ranieri, M.: Employment of higher doses of botulinum toxim tipe A to reduce spasticiy after stroke. J. Neurol. Sci. 350, 1–6 (2015) 16. Esquenazi, A., Albanese, A., et al.: Evidence-based review and assessment of botulinum neurotoxin for the treatment of adult spasticity in the upper motor neuron syndrome. Toxicon 67, 115–128 (2013) 17. Stevenson, V., Playford, D.: Neurological rehabilitation and the management of spasticity. Neurol. Rehabil., 530–536 (2016) 18. Vanegas, H., Perez, C., et al.: Terapia de movimiento inducido por restricción del lado sano: adaptaciones desde fisioterapia a la terapia del lenguaje en usuarios con afasia. Rev. Signos Fónicos, 1–6 (2016) 19. David, J., Balakrishnan, K.: Machine learning approach for prediction of learning disabilities in school age children. Comput. Appl. 9, 10 (2010) 20. Champa, H., AnadaKumar, K.R.: Artificial neural network for human behavior prediction through handwriting analysis. Int. J. Comput. Appl. (2010) 21. Prasad, S., Singh, V.K., Sapre, A.: Handwriting analysis based on segmentation method for prediction of human personality using support vector machine. Int. J. Comput. Appl. 8(12), 25–29 (2010) 22. Iwayama, V., Akiyama, V.: Online handwriting recognition technology and its applications. Fujitsu Sci. Technol., 170–178 (2004) 23. Nishide, S., Okuno, H., Ogata, T., Tani, J.: Handwriting prediction based character recognition using recurrent neural network. In: 2011 IEEE International Conference on Systems, Man, and Cybernetics (2011) 24. Quizhpi, A.: Diseño de una aplicacion multimedia para niños con patálisi cerebral que sufren transtornos del habla y del lenguaje. Reposistorio Universidad del Azual, Cuenca (2016) 25. Meneses Castaño, C., Peñaloza Peñaranda, Y., et al.: Aplicación de la terapia robótica para el tratamiento de la mano espástica del adulto con hemiplejía. Rev. Mex. Med. Fis. Rehabilitación, 80–85 (2015)

568

L. Serpa-Andrade et al.

26. Flores Celis, D.: Software interactivo controlado por un sistema electromiográfico para mejorar la comunicación en pacientes con patálisis cerebral infantil en el hogar clínica San Juan de Dios. Universidad Catóica santo torivio de morgrovejo, Chiclayo (2015) 27. Salinas, P., Prado, F.: Dilemas éticos en niños con enfermedades neuromusculares y dependencias tecnológicas, Archios de pediatría del Uruguay (2016) 28. Vidal, X., Tur, M.: Tratamiento de fisioterapia para la espasticidad en PC. In: ASPACE (2010)

Privacy and Security of Cardiovascular Implantable Electronic Devices: Applying a Contextual Integrity Analysis Beth Strickland Bloch ✉ and Masooda Bashir (

)

School of Information Sciences, University of Illinois, Urbana-Champaign, 501 E. Daniel Street, Champaign, IL 61820, USA {mestric2,mnb}@illinois.edu

Abstract. Technological advancements in the treatment of heart patients with cardiac implantable electronic devices (CIEDs) and remote monitoring systems (RMSs) are fundamentally changing the way physicians and patients relate to electronically shared personal health information. This paper applies a contextual integrity analysis using a nine-step decision heuristic to determine if and how new information flows present potential privacy risks. This analysis finds that the wireless transfer of patient health information from CIED to RMS poses safety and privacy threats to patients and violates contextual integrity. Suggestions for changes to HIPAA regulations and medical device design protocols are presented. Keywords: Information transfer · Privacy risks · Implantable technology · Medical device security · Contextual integrity · HIPAA · Values and ethics

1

Introduction

The use of cardiac implantable electronic devices (CIEDs) has revolutionized the healthcare treatment of cardiac patients since their first introduction in the 1960s [1–3]. The most commonly used of these devices are pacemakers and cardioverter defibrillators in the treatment of bradycardia and cardiac arrhythmias [4]. These devices are implanted inside the patient’s chest cavity near the collarbone, and whereas pacemakers send shocks to the heart as needed to assist with slow heart beats, cardioverter defibrillators are connected to a lead wire which is inserted directly into the heart [5]. Annually, over 1.6 million patients in the U.S. and Europe receive a CIED [6], and medical staff perform 5.5 million in-clinic follow-up appointments with individual who already use CIEDs. The current global cardiology implantables market generates approximately $6.6 billion (USD) every year [7]. Patients who use a CIED have the option of using a remote monitoring system (RMS) to receive in-home treatment. These systems use a variety of open and closed networks to send patient health information (PHI) from implanted device to remotely located physician’s office. The use of RMSs in tandem with CIEDs provide benefits for both patients and health care providers. For example, if a patient was experiencing heart © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_59

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failure, the RMS could send a signal to their physician’s office which would result in emergency assistance being dispatched or in the sending of treatment instructions to the CIED [4, 5]. In a recent study on the effectiveness of CIED treatment when using a RMS, it was found that the 1-year and 5-year survival rates for patients each improved by 50% when compared to patients who only received in-office follow-up care [6]. Healthcare providers also benefits from the use of RMSs when they are used as an alternative for in-clinic follow-ups with patients. For example, CIED patients are required to have follow-up appointments with their physicians every 3–6 months; however, when using a RMS, in-clinic follow-ups are needed only every 12 months. This results in increased convenience for the patient as well as in cost savings of over 40% for health care providers [6]. One key difference between CIED patients who use a RMS and those who do not is how their personal health information (PHI) is managed during the care process. Unlike CIED patients who receive treatment in-person, patients using RMSs must electronically send physicians their PHI through an internet-enabled communication system. Very few studies have yet to consider the potential privacy and security threats of wirelessly transmitting PHI over open networks between CIEDs and external devices. Fewer still examine this phenomenon using a contextual integrity analysis to determine how tech‐ nological mediators in the transfer of information might risk the privacy of patients. In this study, we use a contextual integrity framework to identify the four main contextual elements associated with the wireless transmission of PHI with using CIEDs and RMSs: the context, the actors, the information attributes, and the information transmission principles. We then apply a nine-step decision heuristic to evaluate how new information practices between cardiac patients and physicians present potential privacy risks within a healthcare context.

2

Background

2.1 Information Transfer from CIED to RMS Many contemporary medical devices, not just CIEDs, depend on internet connectivity and wireless communication networks in the transfer PHI from patient to physician. RMSs use a combination of computing components to relay information from CIED to a physician accessible internet-based registry system [4, 8]. Devices are equipped with a small transmitter which relay health information over a wireless a signal to some form of external reader. Some CIED patients have implanted biosensors which read infor‐ mation off the cardiac devices and then wirelessly transmit this information to an external wearable. Other patients must manually wave a wand reader over the implant so infor‐ mation can be transferred [9]. Information held in the wand is then wirelessly transmitted to either a computer inside the patient’s home or to a patient’s smartphone. Patient information is then made available to the treating physician via an online registry system. Most CIEDs are scheduled to automatically transfer two types of information to the RMS: technical information about the integrity of the device, and health information about the patient [4, 10]. The technical information provides reports on the functionality of the device, such as problems with the lead wire, or if cardiac events aren’t being

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recorded properly, and/or the status of the battery. The health information reports on the patient’s current cardiac status, responsiveness to device treatment, and other physio‐ logical markers like weight, blood pressure, and fluid levels [10]. Information that is transferred from the CIED to an external device, such as a computer or smartphone, is not encrypted when wirelessly transmitted [9]. Healthcare providers are at the end of the wireless information transfer process and receive PHI through the registry system. Medical staff are also able to access these systems to retrieve patient data as needed. Depending on the type of CIED used by the patient, providers may also use this system to send treatment protocols back to the device. 2.2 Personal Health Information and HIPAA The way in which patient information is now shared with and managed by healthcare providers is significantly different from traditional methods. Healthcare service models have historically been based on a one-on-one conceptualization of the patient-physician relationship where patient information is stored and managed using a paper-based system. This model of service is reflected in the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Included under Title II of HIPAA is the Privacy Rule which gives patients the right to control how their PHI is shared by healthcare providers known as covered entities. There are three classes of covered entities according to HIPAA rule: 1. Health plans; 2. Health care clearinghouses; and 3. Health care providers who transmit any health information for which the Health and Human Services department have adopted standards [11]. Covered entities can be legally penal‐ ized under HIPAA if they are found to have mishandled patient information and compromised patient confidentiality [12, 13]. The technological advancements which have made remote treatment possible also present new information privacy challenges. The ever-increasing connectivity of implantable medical devices to networked communication systems also present security concerns which may impact patient safety [14]. HIPAA addresses the protection of electronic health information under the Security Rule which serves as a complement to the larger Privacy Rule [15]. The Security Rule specifically targets the roles and respon‐ sibilities of covered entities and identifies three types of security safeguards which need to be maintained: administrative, physical, and technical [15, 16]. Administrative safe‐ guards refer to the policies and procedures entities need to establish and follow to adhere to the regulation. Physical safeguards refer to physical protections entities should provide over patient electronic health information. For example, responsible parties should properly dispose of computer hardware in a manner which ensures electronic health information won’t be intercepted. Lastly, and of notable importance in the case of the wireless transfer of PHI, is that of technical safeguards. These regulations specif‐ ically mention the protections entities need to provide regarding the control of and access to information systems which manage patient PHI over open networks [15, 17].

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2.3 Security Concerns and Technical Challenges The computing capabilities of medical devices to wirelessly transfer PHI present new security and privacy risks. There are two classes of security vulnerabilities which face the use of implantable medical devices; typically thought of as active attacks and passive attacks [20]. First, are control vulnerabilities where unauthorized entities attempt to gain control of device operations and could potentially disable its therapeutic services [9]. Second, are privacy vulnerabilities where patient data is intercepted or accessed by an unauthorized entity [9]. Patients who use CIEDs are especially susceptible to these vulnerabilities given their lack of control over the functionality of these devices [18]. Manufacturers of implantable medical devices face multiple design challenges in the attempt to balance technical constraints with safety concerns. Some of the most pressing technical challenges for implant device development is reducing their size, improving the battery life, and issues of biomaterial compatibility [4, 7, 19]. These challenges are increasingly weighed against the expectations that these devices be internet-enabled for remote treatment management which requires a connection to the external ICT infra‐ structure [2]. Manufacturers of CIEDs are also responsible for the design of the corre‐ sponding RMS. These systems include the design of web applications, multiplatform sensors, custom algorithms, device programming information, and patient and physician alerts about device functionality issues and emergency health events [4]. Although there are calls for increased legislation for the protection of users of implantable medical devices [20], manufacturers are required to adhere to various safety and effectiveness guidelines when seeking governmental approval to market their devices [7, 9]. 2.4 Focus of This Analysis Research about the safety and security of remote treatment systems have existed for some time, however, very few studies have considered the specific privacy challenges encountered when using a wireless method to share PHI. Although research has focused on issues related to internet security and the keeping of stored electronic health infor‐ mation safe, both of which are important within the context of CIED and RMS use, little analysis has focused specifically on privacy and the wireless information transfer process. Studies which have examined the specific security and privacy issues related to this phenomenon tend to focus on technical issues and not on the related social context [2, 21]. Consideration of the social context enables a comprehensive view of the related privacy concerns. In this study, we use a contextual integrity framework to examine how the wireless transfer of PHI challenges traditional privacy expectations and presents potential privacy threats within the context of healthcare.

3

Method

3.1 Privacy and Contextual Integrity Privacy can be a vague and difficult concept to define. For many privacy scholars, privacy is about the process of controlling the flow of personal information [22], and

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about the right of the individual to determine when, how, and to what extent information about them is communication to others [23]. The definition of “what is privacy” is further complicated when the use of technological intermediaries alters the way information has traditionally flowed within a specific context [18, 24]. In a recent position paper about privacy challenges within electronic health information systems, privacy scholar Helen Nissenbaum and her colleagues argue for a privacy position for health information systems founded on contextual integrity [25]. They argue that a contextual integrity view of privacy goes beyond the position that privacy is just about control over one’s infor‐ mation, it’s about determining what is socially acceptable within a specific context based on the related information norms. The guiding information norms of a situation can be determined through the iden‐ tification of four elements as outlined by the contextual integrity framework (Table 1). Table 1. Elements in the contextual integrity framework [26, 27] Element Context Actor

Attribute Transmission principles

Definition The condition of application; the circumstances where a subject agrees with an act Three Placeholders: 1. Senders of information 2. Receivers of information 3. Information Subject What is the information about? Types or nature of the information The specific conditions and/or restrictions which regulate the flow of information from entity-to-entity

Nissenbaum describes a context is a structured social setting characterized by canon‐ ical activities, roles, relationships, power structure, norm/rules, and internal values (i.e. goals, end purposes, so on). Key to understanding privacy from within a contextual integrity framework is the identification of how appropriate flows of personal informa‐ tion are determined by the context [22, 27]. Nissenbaum refers to these as “context-relate information norms” which serve to establish a normative framework in which to evaluate the appropriate and inappropriate transmission of and communication about personal information from one party to another. Information norms are then determined by looking at three key components within the context: the actors involved in the flow of personal information, the attributes of the type of information involved, and the transmission principles which guide the flow of information [22, 27]. The actors include senders of information, receivers of informa‐ tion, and the information subject. Senders may be comprised of single or multiple indi‐ viduals, or of collectives like groups or organizations. Receivers of information may also be comprised of the same categories of actors. Information subjects are comprised of only individuals and may also be the same as the information sender. The attributes of the information refer to the type of information being shared as it relates to the context. Information attributes tell you if the information is public or private, personal or nonpersonal, medical, financial, and so on. Transmission principles dictate the constraints placed on the flow of information and may vary greatly depending on the context. These

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principles guide how information is distributed and disseminated from party-to-party and provide one of the most distinctive aspects of understanding privacy expectations through a contextual integrity analysis [22]. 3.2 Assessing Privacy Risks Nissenbaum suggests the use of a nine-step decision heuristic to determine if a new information flow violates privacy expectations within a certain context (Table 2). This heuristic enables the identification of the four elements important to the contextual integrity framework, and it provides evaluative criteria for the assessment of potential privacy violations which exist within an identified context. Table 2. Contextual integrity decision heuristic [26, 27] Step 1 2 3 4 5 6

7 8

9

Decision heuristic procedure Describe the new practice in terms of information flows Identify the prevailing context; establish context at a familiar level of generality (e.g. “health care”) Identify the actors: information senders, information receivers, information subject Identify the transmission principles Locate the applicable entrenched information norms and identify significant points of departure Prima facie assessment: how a system or practice defies entrenched norms. A breach of informational norms yields a prima facie judgment that contextual integrity has been violated because presumption favors the entrenched practice Evaluation I: Consider the moral and political factors affected by the practice in question (e.g. what might be the harm, the threat to autonomy, to freedom, and so on) Evaluation II: Ask how the system or practices directly impinge on values, goals and ends of the context (e.g. what do harms/threats and/or autonomy and freedom mean in the context) Determine based on these findings if contextual integrity recommends in favor of or against the systems or practices under study

The application of this decision heuristic will allow us to determine if a contextual integrity analysis recommends in favor of or against the practice of the wireless trans‐ mission of information from a CIED and a RMS.

4

Findings

4.1 Step One: New Information Flows Traditionally, PHI is transferred between patient and physician using a paper-based system. A patient visits a physician in-person and then information is collected and written down by the physician and/or the medical staff working in the physician’s office. This information is then kept in a paper file that is managed directly by the physician and his/her staff.

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Information flows differently when using CIEDs enabled with the ability to commu‐ nicate PHI through and with a RMS. Device information and PHI is recorded and stored either on the CIED itself and/or on a related biosensor. This information is then wire‐ lessly transmitted to some type of external device. Patients who have a CIED and use a RMS relay information about their device and their PHI to an internet-enabled registry system [8] which is a proprietary database accessible to physicians and their related staff. There are also two ways information gets transferred to the external device: a patientassisted RMS where the patient actively transfers their PHI, or in a non-patient assisted RMS where information is sent automatically. About 80% of CIED patients who use a RMS use the type which do not require assistance to transmit information [4]. 4.2 Step Two: The Context The new information flows found in the transmission of PHI when using CIEDs and RMSs is located within the larger social context of healthcare. Nissenbaum argues that healthcare is a normative system where the information norms, also known as privacy expectations, are shaped by the social expectation of patient-physician confidentiality [27]. The expectation of confidentiality is one that has been integrated into the overall ethical principles of the healthcare profession. HIPAA also regulates the expectation of confidentiality as enacted by the United States Congress [1, 2]. Under Title II of the act is the Privacy Rule which gives patients the right to control how their health information is shared and used. The Privacy Rule also holds “covered entities”, including healthcare providers, legally accountable for maintaining the confidentiality of patient information [12, 13]. The Security Rule under HIPAA also outlines the role and responsibilities of covered entities in the protection of electronic health information. Confidentiality expectations are addressed explicitly in the three types of security safeguards which need to maintained by covered entities: administrative, physical, and technical. 4.3 Step Three: The Actors There are three sets of actors involved in any context when using a contextual integrity framework: the information subject, the information senders, and the information receivers. The information subject within the context of CIED and RMS use are the actual CIED patients themselves. The information which is transferred from CIED to the RMS is about the patient’s physical health information [4, 8–10]. Transferred infor‐ mation also reports on technical elements related to the device; which depending on what happens with that information, such as it gets intercepted and/or gets modified and alters patient treatment, that information impacts the subject. The use of contextual integrity suggests that there may be multiple senders of infor‐ mation from within the context of CIED and RMS use. The most obvious information senders are patients who are using a CIED. They are involved in the process of when information is sent from device to RMS. However, there are two issues to consider from a contextual integrity viewpoint. First, patients may or may not be fully aware of all the

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PHI that is being sent from the CIED to the RMS [5]. Second, they may also not be aware of when the information is being sent to the RMS if they are using a system that automatically transfers information [18]. This break down of possibly not knowing what information is sent and now knowing when the information is sent raises an important question: who does know the what and when of the transferred information? It’s possible that there is a second information sender involved in the wireless transfer of information from CIED to RMS. The manufacturers of CIEDs and RMSs may have more control over and knowledge about the information which is shared during the wireless transmission process. Those who manufacturer CIEDs, like Boston Scientific Corporation, St. Jude Medical, Medtronic, and Biotronik, are also responsible for the creation the RMS which is used by CIED patients [6, 7]. The use of these technological devices and systems during the information transfer process presents a new actor from a contextual integrity perspective. The final actor to identify within this context is that of the information receivers. Physicians are one of the primary receivers of the PHI which gets sent from the CIED to the RMS. They now receive this information through an internet-enabled database located in a physical location away from the patient. Medical staff also have access to this information. However, additional individuals, for example those who aid in the technical management of transferred and stored PHI, may also have access to this PHI. 4.4 Step Four: Transmission Principles Transmission principles are determined based on the attributes of the information being shared and the conditions of and context in which information is shared. The attributes of the information shared between CIED and RMS is personal (about the information subject), and medical (about the subject’s health condition(s)). It’s being shared within a healthcare context to provide PHI between patient and physician. The transmission principles which place constraints on this information flow is informed by the healthcare context. The most important transmission principle within healthcare is confidentiality. The appropriate flow of information within the CIED and RMS context is from patient to physician, and the principle of confidentiality stipulates that physicians are prohibited from sharing a patient’s PHI with others. The likely transmission principle when sharing PHI from CIED to RMS over a wireless signal is that of confidentiality. 4.5 Step Five: Points of Departure The traditional way of sharing PHI between CIED patient and treating physician is altered when using a RMS. The introduction of internet-enabled devices fundamentally challenges entrenched information norms. Physicians in traditional healthcare settings had to manage paper-based health records to order to protect patient privacy. However, now that information travels electronically, their ability to guarantee patient privacy at each step of the sharing process is challenged. The most significant point of departure within the new information flow is how PHI gets from CIED to RMS. This information is transferred over wireless signals to either external devices or directly to a RMS. This information is also sent over unencrypted

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signals due to technical impediments. The information being sent from CIED to RMS/ external readers is transferred within a healthcare context; therefore, the expected trans‐ mission principle during this transfer process is still confidentiality. However, this prin‐ ciple cannot be followed if PHI isn’t protected during the transfer process. 4.6 Step Six: Prima Facie Assessment The new information flow of how PHI is transferred from CIEDs to RMSs defies the entrenched information norm of privacy within this context. Since the transmission principle of confidentiality cannot be followed during the wireless transmission process, then the expectation of patient privacy is threatened. This new information flow suggests that contextual integrity has been violated since presumption favors the entrenched practice of guaranteeing patient confidentiality. 4.7 Step Seven and Eight: Evaluation I and II CIED patients are an especially vulnerable group given their lack of control over the functionality of these devices [18]. Although the potential for either passive attacks or active attacks to occur during the wireless information transfer process is low, the consequences of such attacks could be life-threatening. There is also the question of what is considered informed consent within this context. Research suggests that patients who use remote medicine technologies often do not understand how PHI is shared or managed [5, 18]. They also do not appear to relate privacy issues with informed consent [28]. Part of this disconnect has comes from a lack of education about the process from their treating physician [6, 10]. Other studies have found a lack of engagement on behalf of the patient to understand the process [5]. These findings suggest that patients need to be better educated about both the benefits and burdens of using RMS systems to give proper consent to sharing their PHI [2]. Physicians are also in a complicated position when it comes to the use of RMS to treat cardiac patients. There are, however, many benefits to using RMS with CIED patients. Use of these systems provide faster response times for intervening in the case of emergency cardiac distress [4]. However, as RMS use aligns with the ethical goals of physicians to improve the quality of life for their patients, the technical limitations impact their ability to guarantee patient privacy. The lack of technical privacy protec‐ tions on the wireless transfer of PHI presents a potential challenge in adequately meeting treatment goals and upholding privacy expectations. 4.8 Step Nine: Final Assessment The findings of this study suggest that contextual integrity may be at risk when wirelessly transferring PHI from CIED to a RMS and/or external device. Given that this wireless transfer of information is not encrypted, it presents the potential for privacy violations unlike those found in traditional healthcare settings. This procedure compromises the transmission principle of confidentially since it cannot be guaranteed throughout the entirely of the information flow process.

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Conclusion

The findings of the analysis suggest that a two-pronged approach would insure greater contextual integrity within the context of CIED and RMS use. First, HIPAA Privacy Rules should be updated to account more adequately for all actors involved in the sharing of PHI within the context of healthcare. As of now, HIPAA identifies three classes of “covered entities”: health plans, health care clearinghouse, and health care providers [11]. Medical devices are now connected to larger information and communication systems and play a role in the health care process. Therefore, device manufacturers, as the creators of these devices, now play a role in shaping how infor‐ mation is managed during the health care process. Physicians and medical staff and no longer the only actors responsible for how the confidentiality of PHI is managed. This suggests that device manufacturers may need to be included under a class of covered entity per HIPAA regulations. This would alter their accountability under the Security Rule which identifies the types of security safeguards covered entities should maintain. This includes technical safeguards which mention the expected protections regarding the control of and access to information networks which manage patient information over open networks [17]. Regulations should implement guidelines that can be used by manufacturers and will define the minimum requirements needed to guarantee the security of patient privacy [29]. Second, device manufacturers should be encouraged to incorporate technical security measures which protect patient PHI during the design phase [20]. Although the use of encrypted wireless signals would eliminate many of the privacy concerns presented in this analysis, the battery life of the CIED needed to support this measure is far higher than is reasonable for routine use [9]. There is also no fast and safe way to re-charge implanted medical devices [8]. Therefore, the use of encryption to protect the wireless transfer of PHI is not yet feasible for use with devices which require surgical implantation [2]. This technical limitation could possibly be overcome through other means if patient privacy is considered earlier during the design phase.

References 1. Blake, H.J., Schwemmer, M.K., Sade, R.M.: The patient-surgeon relationship in the cyber era: communication and information. Thorac. Surg. Clin. 22(4), 531–538 (2012) 2. Kaplan, B., Litewka, S.: Ethical challenges of telemedicine and telehealth. Camb. Q. Healthc. Ethics 17(4), 401–416 (2008) 3. Thoma, H.: Some aspects of medical ethics from the perspective of bioengineering. Theor. Med. Bioeth. 7(3), 305–317 (2008) 4. Pron, G., Ieraci, L., Kaulback, K.: Internet-based device-assisted remote monitoring of cardiac implantable electronic devices: an evidence-based analysis. Ont. Health Technol. Assess. Ser. 12(1), 1–86 (2012) 5. Ottenberg, A.L., Mueller, P.S., Topazian, R.J., Kaufman, S., Swetz, K.M.: It’s Not Broke, So Let’s Not Try to Fix It: why patients decline a cardiovascular implantable electronic device. Pacing Clin. Electrophysiol. 37(10), 1306–1314 (2014)

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6. Ottenberg, A.L., Swetz, K.M., Mueller, L.A., Gerhardson, S., Mueller, P.S.: We as human beings get farther and farther apart: the experiences of patients with remote monitoring systems. Heart Lung 42(5), 1–15 (2013) 7. Barnes, M.: Implantables: market challenged by safety concerns and restricted innovation. Med. Des. Technol. 17(9), 32–34 (2013) 8. Bauer, K.A.: Wired patients: implantable microchips and biosensors in patient care. Camb. Q. Healthc. Ethics 16, 281–290 (2007) 9. Burleson, W., Clark, S.S., Ransford, B., Fu, K.: Design challenges for secure implantable medical devices. In: Proceedings of the 49th Design Automation Conference (DAC 2012), pp. 12–17 (2012) 10. Versteeg, H., Pedersen, S.S., Mastenbroek, M.H., Redekop, W.K., Schwab, J.O., Mabo, P., Meine, M.: Patient perspective on remote monitoring of cardiovascular implantable electronic devices: rationale and design of the REMOTE-CIED study. Neth. Heart J. 22(10), 423–428 (2014) 11. National Institutes of Health, HIPAA Privacy Rule and Research. https:// privacyruleandresearch.nih.gov/pr_06.asp#6a 12. Centers for Disease Control and Prevention, HIPAA Privacy Rule and Public Health. http:// www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm 13. Terry, K.: Patient privacy. The new threats. Phys. Pract. 19(3), 1–12 (2009) 14. Katzis, K., Jones, R.W., Despotou, G.: The challenges of balancing safety and security in implantable medical devices. Stud. Health Technol. Inform. 226, 25–28 (2016) 15. Hash, J., Bowen, P., Johnson, A., Smith, C.D., Steinberg, D.I.: An introductory resource guide for implementing the health insurance portability and accountability act (HIPAA) security rule. National Institute of Standards and Technology (2005) 16. Wafa, T.: How the lack of prescriptive technical granularity in HIPAA has compromised patient privacy. North. Ill. Univ. Law Rev. 30(3), 531–552 (2010) 17. U.S. Department of Health and Human Services, Health Information Privacy, The Security Rule. https://www.hhs.gov/hipaa/for-professionals/security/index.html?language=es 18. Diamond, C., Goldstein, M., Lansky, D., Verhulst, S.: An architecture for privacy in a networked health information environment. Camb. Q. Healthc. Ethics 17(4), 429–440 (2008) 19. Kiourti, A., Psathas, K.A., Nikita, K.S.: Implantable and ingestible medical devices with wireless telemetry functionalities: a review of current status and challenges. Bioelectromagnetics 35(1), 1–15 (2014) 20. Camara, C., Peris-Lopez, P., Tapiador, J.E.: Security and privacy issues in implantable medical devices: a comprehensive survey. J. Biomed. Inform. 55, 272–289 (2015) 21. Kling, R.: What is social informatics and why does it matter? Inf. Soc. 23(4), 205–220 (2007) 22. Barth, A., Datta, A., Mitchell, J.C., Nissenbaum, H.: Privacy and contextual integrity: framework and applications. In: IEEE Symposium on Security and Privacy (S&P 2006), pp. 183–198 (2006) 23. Shilton, K., Burke, J., Estrin, D., Govindan, R., Hansen, M., Kang, J., Mun, M.: Designing the personal data stream: enabling participatory privacy in mobile personal sensing. In: The 37th Research Conference on Communication, Information and Internet Policy (TPRC 2009), pp. 1–17 (2009) 24. Shih, F., Zhang, M.: Towards supporting contextual privacy in body sensor networks for health monitoring service. In: W3C Workshop on Privacy and Data Usage Control, pp. 1–5 (2010) 25. Datta, A., Dave, N., Mitchell, J.C., Nissenbaum, H., Sharma, D.: Privacy challenges in patientcentric health information systems. HealthSec, 1–2 (2010)

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26. Huang, H.-Y., Bashir, M.: Direct‐to‐consumer genetic testing: contextual privacy predicament. In: Proceedings of the Association for Information Science and Technology (ASIST 2015), pp. 1–10 (2015) 27. Nissenbaum, H.: Privacy in Context: Technology, Policy, and the Integrity of Social Life. Stanford University Press, Palo Alto (2010) 28. Segura Anaya, L.H., Alsadoon, A., Costadopoulos, N., Prasad, P.W.: Ethical implications of user perceptions of wearable devices. Sci. Eng. Ethics 1–28 (2017) 29. Allaert, F.A., Mazen, N.J., Legrand, L., Quantin, C.: The tidal waves of connected health devices with healthcare applications: consequences on privacy and care management in European healthcare systems. BMC Med. Inf. Decis. Mak. 17(1), 1–10 (2017)

Method of Ergonomics Assessment of Technical Systems and Its Influence on Operators Heath on Basis of Hybrid Fuzzy Models Riad Taha Al-Kasasbeh1(&), Nikolay Korenevskiy2, Mahdi Salman Alshamasin1, and Ilyash Maksim3 1

2

Faculty of Engineering Technology, Al-Balqa Applied University, Amman 11937 P.O. Box 541324 Jordan [email protected], [email protected] Southwest State University, 305040 St. 50 Let Oktyabrya, 94, Kursk, Russia [email protected], [email protected] 3 Saint Petersburg State University, Saint Petersburg, Russia [email protected]

Abstract. The paper discusses the problems of determining the ergonomics level of technical systems based on fuzzy mathematical models. The role of the ergonomics in development and occurrence of occupational diseases using sets of hybrid fuzzy decision was studied. Checking decision rules on representative test samples showed that the resulting system of fuzzy inference rules can solve the problem of predicting the appearance of cochlear jade with confidence above 0.87 early diagnosis of the disease which allows recommending the use of the results obtained in clinical practice. Keywords: Ergonomics level
Technical systems hybrid decision rules
Prediction
Early diagnostics


Fuzzy logic
Sets of
Occupational diseases

1 Introduction Numerous scientists research in different countries of the world point that quality of biotechnical systems work of various types and appointments depends on ergonomics of the technical subsystems contacting to the person. The indicators characterizing ergonomics of technical systems have essential impact on the person’s functional state and health [1–3]. Considering ergonomics as the complex applied branch of science which is engaged in studying of the person in production environment and design of mechanisms, products and workplaces the most convenient for a worker that means interdisciplinary science should at creation of mathematical models describing influence of technical subsystems on a person, to use methods and means of the system analysis. The indicators of ergonomics characterizing convenience and comfort of the person, contacting to technical systems, consist of a number of hygienic, anthropometrical, physiological (psychophysical) and psychological characteristics. © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_60

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In turn, each of these characteristics (subgroups) is described by a set of diverse indicators. The ergonomic assessment of TS can be brought both on its separate components and on all system with use of tool, settlement and expert methods. Traditionally an assessment of ergonomic indicators is given by comparison of defined values to the set or basic values. For basic values are often taken the values given in the state and industry standards, in sanitary standards and the rules, received in the best conventional products, etc. As the complex generalizing level indicator of an ergonomic product is often used coefficient of working conditions of KWC which is defined by work of coefficients of change of labor productivity DPi - at change i- of ergonomic characteristic of a product. Often expert assessment of ergonomics of TS is carried out, using traditional system of mark estimates, and also a method of the alternative principle, defining compliance or discrepancy of the chosen indicator to the accepted norms. In the last option, the general assessment of level of ergonomics is defined by the relation of ergonomic properties number conforming to the chosen requirements to total number of the studied ergonomic properties. The analysis of the listed and other methods of an assessment of the TS ergonomic properties and the indicators used for this purpose shows that they don’t answer, with sufficient degree of accuracy, a question of interrelation of level of ergonomics with a functional state and a health state of operators, changing from their interaction with the relevant technical systems. It is connected first of all with complexity of receiving exact analytical models of an assessment of a condition of the person contacting to dynamically changing outside world including TS. On the other hand in a number of works [4–17] it was shown that in bad formalization conditions, at insufficient amount of information and at indistinctly defined classes enough good results will manage to be reached when using methodology of soft calculations, including the theory of fuzzy logic of decision-making and the theory of confidence adapted on the solution of classification tasks taking into account the analyzed structures of data [4, 5, 7, 8, 13, 16–18].

2 Research Methods We will consider the problem of an assessment of ergonomics of technical systems in two options. As a problem of receiving the continuous scale characterizing the ergonomics level and as a problem of classification (referring to the TS and (or) her subsystems to one of the set ergonomics conditions). We will consider a problem of the health assessment of a person contacting to the HARDWARE as a problem of classification (referring to one of classes of diseases which can be provoked by the contact with the TS (prognosis) and to a class of diseases which are already present at the person and one of the factors promoting this disease was a contact of the person with the TS. In all these options both the level (class) of ergonomics, and the predicted (defined) disease are determined by the set of the measured signs which in turn are not always accurately defined presented in full structure. Besides the concept of the ergonomics level (class), the prognosis and the diagnosis (especially early) are not usually

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accurately determined that doesn’t allow to get the rigid analytical models of their description. Taking this into account, by the analogy with the theory of the fuzzy decision-making logic, as a Basic Element of the corresponding decision-making models we will enter the characteristic functions of accessory to the concepts of ergonomics level (class) and to the classes of predicted and (or) diagnosed diseases. We will determine the level of the system’s ergonomics as a whole through family of private levels of ergonomics by which the Basic Elements are the functions of ergonomics level Us ðxi Þ of the S subsystem of basic xi variables defined by hygienic, anthopometrical, physiological indicators and psychological characteristics with an area of definitions on an interval [0, 1]. At a choice of a form and parameters of the functions of ergonomics level it is necessary to be guided by those purposes for the sake of which the assessment of ergonomics level is made as they can differ a little from each other. For example, priorities can be given to: convenience and comfort of the user, minimization of harm to health on bodies, systems and an organism as a whole; ensured) the maximum reliability of BTS functioning; at the same time to several purposes. As reference points for the choice of the maximum Us ðxi Þ meanings can serve: state and industry standards; sanitary standards and rules; indicators reached in the best technical samples at world and (or) regional levels; maximum level of safety; minimum negative influence on a state of health, etc. One more reference point at a choice of the maximum Us ðxi Þ meanings is the way of their aggregation in final assessment model of ergonomics level of UE for which the condition has to be satisfied UE ¼ Fag ½Us ðxi Þ  1;

ð1Þ

where Fag - functionality of aggregation. Zero values US ðxi Þ are selected for the values (intervals) of xi not arranging the user. The form and the Us ðxi Þ parameters can be got out and be specified during carrying out psychophysical, medicobiological, reliability and other experiments defined by the essence of solving tasks which largely define the selection of functional aggregation. For example, if insufficient ergonomics level of at least one of private components has to be considered as critical on the relation to the whole system (subsystem) of s, the general level of ergonomics is defined by the expression: UEs ¼ mini ½Us ðxi Þ;

ð2Þ

If at an expert level the decision that each private indicator of ergonomics level, forming an appropriate level of all subsystem (system) is made, increases the size of UES, then the accumulative interaction formula can be used: UEs ði þ 1Þ ¼ UEs ðiÞ þ UEs ðxi þ 1 Þ½1  UEs ðiÞ; where UEs ð1Þ ¼ Us ðx1 Þ:

ð3Þ

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In option when private indicators of ergonomics level bring defined (set by experts in the form of weight coefficients ai) contribution to the general indicator of UEs, can be used aggregating expression: PI UEs ¼

j¼1

ai  Us ðxi Þ ; I

ð4Þ

where 0  ai  1; I - quantity of signs participating in calculation UEs. In general, the symptoms xi can be obtained: by direct measurements on the test TC; measurements carried out on a specially created simulator, by measuring the mental and physical sensations; with known or specially created questionnaires etc. A particular interest is a group of indicators that characterize complex human reactions to its interaction with the TS. For example, such indicators should include the level of emotional stress, mental and physical fatigue, etc. When passing to the classification levels of ergonomics the index UEs is selected as the basic variable for membership functions to the selected class ergonomics, such as classes of non-ergonomic products (ln(UE)); satisfactory level (ls(UE)); good level (lg(UE)); advanced level (la(UE)) [1, 2]. Figure 1 shows graphs options of fuzzy classification of level ergonomics.

µ Н (UE )

µУ (UE )

µ X (UE )

1,0

0,1

0,2

0,3 0,4

0,5 0,6 0,7

µ П (UE )

UE 0,8

0,9 1,0

Fig. 1. Option of fuzzy classification of level ergonomics.

Solving the problem of assessing the impact of the level of ergonomics on human health it should be taken into account that significant risk factors for human rights are also the environmental conditions and individual risk factors connected with the characteristics of an organism of a particular person and his lifestyle. In such feature space problems of health assessment, in particular the problems of forecasting and early diagnosis of diseases and the evaluation of the functional state of a person, as a classification problem, are characterized by incomplete and fuzzy representation of data with ill-defined boundaries intersecting classes, which makes it is necessary to use of fuzzy logic decision-making [4, 7–9, 11, 12, 15, 17–19]. One of the main problems of practical application of this mathematical apparatus is a difficulty to choose the shapes and parameters of elements of fuzzy decision rules and methods of their aggregation in the system of fuzzy decision rules. Most of these

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problems can be solved by the use of hybrid collectives fuzzy decision rules, the training of which is carried out by using data of exploratory analysis [6–9]. The practice of solving problems of prediction and medical diagnostics has shown that in the conditions of poor formalization with insufficient statistics and the choice of the type of decision rules, united in their groups, it’s quite necessary to use a serial sequential analysis of Wald dialog recognition systems and fuzzy logic decision-making in its applications to solve classification problems [7–13]. In turn, the development of the theory of fuzzy logic decision-making has led to the realization that different structures of medical data (that is minimizing the classification errors) fit better for different types of fuzzy decision rules (Minimax surgery [4, 7, 9, 12, 13, 15], the membership function with the basic variable in distance to the separating surfaces and reference structures [10, 11], modifications iterative rules of E. Shortlifa [6, 7, 13, 20], etc.). It was shown by the work of the Department of Biomedical Engineering Southwestern State University (BMI SWSU, Russia) that the choice of the elements of fuzzy decision rules and methods/their aggregation with the further joining into fuzzy groups is necessary to carry out, based on the methodology of exploratory analysis [7, 9]. To solve the problems of the synthesis of fuzzy decision rules at the Department of BMI SWSU it was developed a special software package of exploratory analysis with the recommendations of the selection, types of membership functions and methods of their aggregation, depending on the data structure, is characteristic for these or those types of health problems [6, 7, 9, 11]. It was found that for different groups of informative features involved in solving the selected task the most appropriate (in the sense of minimum classification error and professional understanding of the experts) are different types of fuzzy decision rules. Besides, in the space of informative features for its various hot spot may also be necessary to the use different classification rules. This fact has allowed to make a conclusion about the necessity of developing mechanisms for the synthesis of different types of decision rules and with the further combining them into groups of hybrid solvers. One of the methodological approaches to such synthesis is proposed in this work as the following sequence of actions. 1. If at the expert level, and in the course of exploratory analysis it is shown the possibility of the formation of the feature space or subspace, where each of the signs of xi will be represented the system k of gradation xik and it is possible to make a statistical calculation of relative frequencies to the emergence of second k-th gradatsi i-th feature in alternative classes xl and xr  Pðxik =xl Þ, Pðxik =xr Þ we study the feasibility of using sequential procedure of Wald counting the diagnostic factor according to the formula [7, 9, 21]: DF ¼

Xn i¼1

101g

Pðxik =xl Þ ; Pðxik =xr Þ

ð5Þ

Where xl and xr alternative diagnostic classes (ranges); xik - meaning k-th graduation informative feature xi, (i = 1,…, n), n - uniformity of feature space; P P(xik/xl) - a detail displays the k-th gradation of the i-th feature in class xl; P(xik/xr) - in the class xr.

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When passing to the Valdovsky fuzzy classifier the confidence in the classification xl - UGVl is determined by the membership function to xl with a base variable which is defined on a scale of DF [21]. UGVl ¼ ll

ð6Þ

The advantages of this procedure are the simplicity of the calculations, the absence of specific requirements for the statistical distribution of the studied dimensions and the possibilities of diagnosis with pre-established levels of reliability, even in the absence of some of the measurements. The limits of the application of this method are the requirement for the amount of the training sample and its representativeness, the area existence of uncertainty solutions that for values of a and b approaching unity (high quality classification) can be very wide and the independence of attributes involved in the diagnosis. Nevertheless, even with very pronounced dependence symptoms, the number of errors in serial diagnostic procedure is usually not higher than the settlement. 2. If in the course of analysis of intelligence which actively uses various methods of multivariate data in two-dimensional spaces is seen the quality of classification in these spaces, it is necessary to stop using the dialogue design of two-dimensional classification space [16]. In accordance with this method, a two-dimensional mapping of the space F = Y1 * Y2 is defined as the Cartesian product of two functions as: ð7Þ where u1 and u2 –the functions of display multi-dimensional objects in two-dimensional space F; A and B - the vectors of adjustable parameters; X = {x1,…, xn}–the vectors of objects of the multidimensional space of informative features. On the base of learning objects in the space F in semi-automatic mode, with the involvement of domain boundaries are formed of alternative classes are formed xl and xr out of the minimum number of classification errors in the form of equation: Gl ¼ Fl ðY1; Y2Þ. In the transition to the fuzzy classification in two-dimensional space, the exact output of the method of designing two-dimensional classification of dialogue spaces is transformed into fuzzy decision on the definition of membership functions ll(xi) to the class of xl with the main variable defined as the distance Dl from the display of the object till two-dimensional boundaries of class xl, described by equation glance Gl ¼ Fl ðY1 ; Y2 Þ. We define the confidence of xl taken from a dialog design of two-dimensional classification space: UGDl ¼ lxl ðDl Þ;

ð8Þ

Using modifications of the classical fuzzy logic decision-making L. Zadeh focused on solving the problems of classification, the auxiliary functions are used lxl(xi) and (or) lxl(Yj) to the studied classes conditions xl basic variables defined factors of

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informative features xi and (or) complex parameters Yj, calculated informative indices Yj ¼ fj ðx1 ; x2 ; . . .Þ, where fj is a functional dependence connecting all or part of the informative features with Yj [6, 7, 12, 13]. The most popular formula, aggregating in the use of membership functions are expressions as:    UGNl ¼ minj lx Yj ;

UGNl ¼

min i;j

UGNl ¼ max i ½lx ðxi Þ;

   UGNl ¼ max j lx Yj ;

UGNl ¼

max i;j

UGNl ¼ max q

UGNl ¼ max q

UGNl ¼ mini ½lx ðxi Þ;

min i ½lx ðxi Þ;

min j



  lx Yj ;

UGNl ¼ max q

   lxl ðxi Þ; lx Yj

ð9Þ

   ð10Þ lxl ðxi Þ; lx Yj

min i;j



  lxl ðxi Þ; lx Yj ð11Þ

where q - a number of hyper-volumes covering the class xl. Expressions like (9) should be used if the subspace or feature space all of them are like that no one of them requires the rejection from xl. These rules from the geometrical point of view can be considered as the classification of hitting to the object studied in a fuzzy hyper parallelepiped limited to non-zero values of all using functions. (10) it is necessary to use the expression, if the existence of any features enough to evaluate hypotheses xl. If in the feature space is the subgroups satisfying (9) and (10), it is recommended to use the rules like (11). Geometrically, this rule is an approximation of geometrical images corresponding to the studied classes of states by sets of fuzzy hyper-parallelepipeds with numbers q in the class xl. 4. If in the course of analysis, it is clear that between the studied classes of states can be dividing hyper plane as Zl = Fl(Al, xl), it is necessary to use the rules like: UGGl ¼ lxl ½Dl ðZl Þ;

ð12Þ

where Fl –a detection separating the dividing surface (linear, piecewise linear and, square, etc.); Dl (Zl) - a function of distance from the studied objects to the dividing surface Zl [2]. 5. If a group or all of the informative features x, or complex indicators Y, are like that each of them increases the confidence in the hypothesis (diagnosis W1), so private and (or) total confidence in UGSl and xl recommended determined by the formulas [4, 6–9, 13]. UGSl ðp þ 1Þ ¼ UGSl ð pÞ þ lx ðxi Þ½1  UGSl ð pÞ UGSl ðp þ 1Þ ¼ UGSl ð pÞ þ lx Yj ½1  UGSl ð pÞ UGSl ðp þ 1Þ ¼ UGSl ð pÞ þ USl ðp þ 1Þ½1  UGSl ð pÞ

ð13Þ

where p - the number of iterations per UGSl; USl(p + 1) - a private confidence in xl on the subspace with index p + 1 multi-dimensional feature space. 6. If the electrical characteristics of biologically active points (BAP) are used as the informative features, for example, their electrical resistance are so with the biophysics of these points and the specific output of information on them in the functions

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[4, 6, 12, 18, 19, 22–24] it is recommended to use a hybrid decision rule consisting of the exact status and rules of fuzzy decision-making as:  if Yjl 8½DZGl dRj  dRnop j ; else     UGBl ðj þ 1Þ ¼ UGBl ð jÞ þ lxl dRj þ 1 ½1  UGBl ð jÞ then ðUGBl ¼ OÞ;

ð14Þ

where Yjl- a list of informative points on disease; xl, 8 - community quantifier; [DZG]la list of diagnostically significant moments the analysis of which lets to output the set of pathology out of many information; dRj –a relative deviation of the resistance to the BAP with number j of the nominal exchange rate; dRnop j - threshold value dRj, deter  mined during the synthesis of decision rules; lxe dRj þ 1 - function belonging to the class xl of the main a base variable dRj þ 1 ; UGBl - confidence in the diagnosis of xl, UGBl ð1Þ ¼ lxl ðdR1 Þ. In relation to feature space of fuzzy rules is distributed depending on the particular object [8, 10]. Alternatively, when each of the rules develops their groups of features, for example, surveys are aggregated according to the rule (13), the data from traditional laboratory studies by the rule got in the processing by the rule (12), the results of the analysis of the energy characteristics of biologically active points –by the rule (14), etc. In another version of all the informative features are processed by each of the rules included in the team. Mixed option is possible when different decision rules use mixed probably crossed, groups of information signs. Such groups may be created by different principle: by receiving information; by measuring process; by the information content; by the characteristics of data structures, etc. The options of final aggregation decision rules may be different, too. In a cautious strategy when a decision has to be taken into account with the necessary viewpoint of all members of the group, considering the possible doubt in the direction of alternative (class xl) it is good to use a type of aggregator: UGl ¼ min ðUGVl ; UGDl ; UGNl ; UGGl ; UGSl ; UGBl Þ;

ð15Þ

If the problem “is not let pass” the objects of the class, or if the degree of confidence to each of the decision rules is about the same it is necessary to check the applicability of (the quality of) the essential rule as: UGl ¼ max ðUGVl ; UGDl ; UGNl ; UGGl ; UGSl ; UGBl Þ;

ð16Þ

If the use of each of the rules adds a confidence in accepting decisions concerning xl hypothesis, it is good to use the iterative procedures for collecting, for example, by E. Shortlifu: UGl ðs þ 1Þ ¼ UGl ðsÞ þ UGFl ðs þ 1Þ  ½1  UGl ðsÞ;

ð17Þ

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where s –a number of iterations in the calculation of confidence UGl in xl classification; UGFl ¼ ðUGVl ; UGDl ; UGNl ; UGGl ; UGSl ; UGBl Þ; UGð1Þ ¼ UGFð1Þ

ð18Þ

In practice, there are tasks with the complex structure of datas when in the final decision rule it is necessary to combine the options of aggregation by the rules (15), (16), (17).

3 Practical Example As an example, let’s examine the problem of estimating the level of ergonomics such vehicles as the tractor. As the primary characteristics used for estimating the level of ergonomic cabin at the expert level were selected: the temperature in the cabin (x1); the noise level in the cabin (x2); the average load on the arm (x3); the average load on the legs (x4), the body vibration (x5), the vibration on the hands (x6), the vibration on the legs (x7), the angle of inclination of the seat (x8), height (x9), distance to the main controls (x10); the level of mental and emotional stress connected with the workplace (x11) and the level of chronic physical fatigue (x12) [1, 2]. For the construction of private functions on the basis of ergonomic conditions x1 − x10 two approaches were chosen: the method of psychophysical scaling and the construction of specialized test questionnaires. The results of L. Kamozina were used to select the analytic expressions and graphing private level functions ergonomics. In this work there are the psychophysical scale sensations of a driver depending on the physical parameters of the effects. For example, for a characteristic x1 - the temperature in the cabin is obtained psychophysical scale as:   ST ¼ 8; 93  104  T b ; ;

ð19Þ

T - physical temperature; ST - thermal sensations of the probationer; b - the exponent depending on the individual subject’s psychophysics, lying in the range of 1.96… 3.67. Studies have shown that most of the subjects tested as the most comfortable temperature call interval 22… 24° C [2]. U (t ) = U (х1 ) 1,0

0,5

10

12

14

16

18

20

22 24 26 28 30 32

34 36

38

40

42 44

Fig. 2. Schedule of the level of ergonomics in terms of temperature

t град

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Considering the Delphi method, according to a survey of the expert group of 7 people, was built a private function in terms of the level of ergonomics average temperature in the cabin (see Fig. 2).

4 Conclusion 1. The method of indistinct models’ synthesis for the description and the evaluation of the ergonomic level of technical systems based on aggregation of such diverse indicators as direct measurement results of ergonomic parameters; physical modeling, psychophysical scaling and test poll allows to estimate the ergonomic level of both separate elements and knots, as well as of technical systems in general and to consider their influence on the health of operators working in biotechnical systems. 2. The synthesized system of indistinct output rules allows to solve problems of forecasting the cochlear neuritis emergence with confidence higher than 0.9 in early diagnosis of this disease - with confidence not worse than 0.87 that allows to recommend the use of the received results in medical practice. In [25–31] several mathematical models for the interaction of the internal and biological active points of meridian structures have been proposed. The analysis of these models allows the specification of a list of occupational diseases for which reflex diagnostics and reflex therapy methods are most effective and also allows increasing the effectiveness of these procedures. It is shown that good results for the prediction and early diagnosis of diseases from the reaction energy of biologically active points (acupuncture points) are obtained using fuzzy logic decision making. Acknowledgements. We gratefully acknowledge funding from the German Research Council (DFG) and additional support from Al-Balqa’ Applied University in Jordan, South West State University in Russia, University of Applied Sciences (HTWG) in Konstanz, Germany and the Higher Council for Science and Technology of Jordan.

References 1. Korenevskiy, N.A., Gadalov, V.N., Korovin, E.N., Serebrovskiy, V.I.: Assessment of ergonomics of biotechnical systems using shortliffe fuzzy models. Biomed. Eng. 47(4), 173–176 (2013) 2. Korenevsky, N.A., Korostelev, A.N., Serebrovsky, V.V., Sapitonova, T.N.: The estimation of farm vehicles ergonomics and its use in assessment of the condition of agrarian-industrial complex employees. Bull. Kursk State Agric. Acad. 1, 122–127 (2012) 3. Al-Kasasbeh, R., Korenevskiy, N., Ionescou, F., Alshamasin, M., Kuzmin, A.: Synthesis of fuzzy logic for prediction and medical diagnostics by energy characteristics of acupuncture points. J. Acupunct. Meridian Stud. 4(3), 175–182 (2011) 4. Al-Kasasbeh, R.T., Korenevskiy, N.A., Ionescu, F., Kuzmin A.A.: Synthesis of combined fuzzy decision rules based on the exploration analysis data. In: Proceedings of the 4th IAFA International Conference on Interdisciplinary Approaches in Fractal Analysis, Bucharest, pp. 71–78 (2009). ISSN 2066-4451

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5. Buchanan, B.G., Shortliffe, E.H.: Rule-Based Expert Systems: The MYCIN Experiments of the Stanford Heuristic Programming Project. Addison-Wesley Publishing Company, Reading (1984). ISBN 0-201-10172-6 6. Korenevsky, N.A., Krupchatnikov, R.A., Al-Kasasbekh, R.T.: Theoretical fundamentals of biophysics of acupuncture with applications in medicine, psychology and ecology on the basis of indistinct network models. Stary Oskol: TNT (2013). ISBN 978-5-94178-398-4 7. Korenevsky, N.A., Bashir, A.S., Gorbatenko, S.A.: Synthesis of hybrid indistinct rules for forecasting, estimation and management of health in ecologically adverse regions. News of Southwest state university, series: management, computer facilities, informatics. Med. Instrum. Mak. 4, 69–73 (2013) 8. Korenevsky, N.A.: Method of heterogeneous indistinct rules synthesis for the analysis and management of a biotechnical systems’ condition. News of Southwest state university, series: management, computer facilities, informatics. Med. Instrum. Mak. 2, 99–103 (2013) 9. Korenevsky, N.A., Rutskoi, R.V., Dolzhenkov, S.D.: Method of forecasting and diagnostics of health on the basis of collectives of indistinct decisive rules. Syst. Anal. Manag. Biomed. Syst. 12(4), 905–909 (2013) 10. Korenevsky, N.A., Filist, S.A., Ustinov, A.G., Ryabkova, E.B.: Geometrical approach to indistinct decisive rules synthesis for solving the problems of forecasting and medical diagnostics. Biomed. Radio Electron. 4, 20–26 (2012) 11. Korenevskiy, N.A., Degtyarev, S.V., Seregin, S.P., Novikov, A.V.: Use of an interactive method for classification in problems of medical diagnosis. Biomed. Eng. 47(4), 169–172 (2013) 12. Korenevskiy, N.A., Gorbatenko, S.A., Krupchatnikov, R.A., Lukashov, M.I.: Design of network-based fuzzy knowledge bases for medical decision-making support systems. Biomed. Eng. 43(4), 187–190 (2009) 13. Korenevskiy, N.A., Krupchatnikov, R.A., Gorbatenko, S.A.: Generation of fuzzy network models taught on basic of data structure for medical expert systems. Biomed. Eng. J. 42(2), 67–72 (2008) 14. Pal, N.R., Eluri, V.K., Mandal, G.K.: Fuzzy logic approaches to structure preserving dimensionality redaction. IEEE Trans. Fuzzy Syst. 10(3), 277–286 (2002) 15. Shapovalov, V.V.: Indistinct method of decisive rules creation in systems of screening diagnostics. Biomed. Radio Electron. 1, 64–66 (2013) 16. Ustinov, A., Boitsov, A., Korenevskaya, S., Khripina, E.: Intelligent medical systems with groups of fuzzy decision rules. In: 10th Russian-German Conference on Biomedical Engineering, pp. 90–92. Saint Petersburg State Electrotechnical University, Saint Petersburg (2014) 17. Zadeh, L.A.: Advances in Fuzzy Mathematics and Engineering: Fuzzy Sets and Fuzzy Information-Granulation Theory. Beijing Normal University Press, Beijing (2005). ISBN 7-303-05324-7 18. Korenevskiy, N.A., Al-Kasasbeh, R.T., Ionecou, F., Alshamasin, M., Kuymin, A.: Prediction and prenosological diagnostics of heart diseases based on energy characteristics of acupuncture points and fuzzy logic. Comput. Methods Biomech. Biomed. Eng. 15(7), 681–689 (2012) 19. Al Kasasbeh, R.T., Korenevskiy, N.A., Ionescu, F., Alshamasin, M.: Prediction and prenosological diagnostics of gastrointestinal tract diseases based on energy characteristics of acupuncture points and fuzzy logic. In: International Conference on Bioinformatics and Biomedical Technology, Sanya, pp. 307–312 (2011) 20. Shortliffe, E.H.: Computer-Based Medical Consultations. MYSIN, New York (1976) 21. Gubler, E.V., Genkin, A.A.: Application of nonparametric methods of statistics in medicobiological researches. Medicine, Leningrad (1973)

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R.T. Al-Kasasbeh et al.

22. Korenevskiy, N.A., Al-Kasasbeh R.T., Ionescu, F., Alshamasin, M., Al-Kasasbeh, E., Smith, A.P.: Fuzzy determination of the human’s level of psycho-emotional. In: Mega-Conference on Biomedical Engineering, Proceedings of the 4th International Conference of the Development of Biomedical Engineering, Ho Chi Minh City, Vietnam, pp. 354–357 (2012) 23. Korenevskiy, N.A., Al-Kasasbeh, R.T., Ionescu, F., Alshamasin, M., Alkasasbeh, E., Smith, A.P: Fuzzy determination of the human’s level of psycho-emotional. In: IFMBE Proceedings, pp. 213–216 (2013) 24. Korenevskiy, N.A., Al-Kasasbeh, R.T., Alshamasin, M., Ionescou, F., Smith, A.: Prediction of gastric ulcers based on the change in electrical resistance of acupuncture points using fuzzy logic decision-making. Comput. Methods Biomech. Biomed. Eng. 16(3), 302–313 (2013) 25. Al-Kasasbeh, R., Korenevskiy, N., Alshamasin, M., Klionskiy, D., Ionescou, F.: Numerical software algorithms for monitoring control processes and correcting health by synthesis of hybrid fuzzy rules of decision-making on the basis of changes in energetic characteristics of biologically active points. Int. J. Model. Identif. Control 25(2), 119–137 (2016) 26. Al-Kasasbeh, R., Korenevskiy, N., Alshamasin, M., Klionskiy, D.: Bioengineering system for prediction and early prenosological diagnostics of stomach diseases based on energy characteristics of bioactive points with fuzzy logic. J. Biosens. Bioelectron. (2015). doi:10. 4172/2155-6210.1000182 27. Korenevskiy, N., Alshamasin, M., Al-Kasasbeh, R., Krupchatnikov, R.A., Ionescou, F.: Prediction and prenosological diagnosis of stomach diseases based on energy characteristics of acupuncture points and fuzzy logic. Int. J. Model. Identif. Control 23(1), 55–67 (2015) 28. Al-Kasasbeh, R., Zaubi, M.A.A., Korenevskiy, N., Al-Shawawreh, F., Alshamasin, M., Ionescu, F.: A biotech measurement software system using controlled features for determining the level of psycho-emotional tension on man-machine system operators by bio-active points based on fuzzy logic measures. Int. J. Model. Identif. Control 22(4), 375–395 (2014) 29. Al-Kasasbeh, R., Korenevskiy, N., Ionescou, F., Alshamasin, M., Smith, A.P., Alwadie, A., Aljbour, S.: Application of fuzzy analysis with the energy condition of bioactive points to the prediction and diagnosis of gastrointestinal tract diseases. Int. J. Biomed. Eng. Technol. 11 (2), 1752–6426 (2013). ISSN online: 1752-6426, ISSN print: 1752-6418 30. Al-Kasasbeh, R., Korenevskiy, N., Ionescou, F., Alshamasin, M., Smith, A.P., Alwadie, A.: Biotechnical measurement and software system for the prediction and diagnosis of osteochondrosis of the lumbar region based on acupuncture points with the use of fuzzy logic rules. Biomed. Eng. Biomedizinische Technik 58(1), 51–65 (2013). doi:10.1515/bmt-20120081. ISSN 1862-278X 31. Al-Kasasbeh, R.: Biotechnical measurement and software system controlled features for determining the level of psycho-emotional tension on man–machine systems by fuzzy measures. Adv. Eng. Softw. 45, 137–143 (2012). ISSN: 0965-9978

Hazard and Safety Analysis of the Integra™ UltraVS™ Neonate Valve Amber Torrez(&) Colorado State University-Pueblo, 2200 Bonforte Blvd, Pueblo, CO 81001, USA [email protected]

Abstract. The purpose of the research was to perform a hazard and safety analysis on an Integra™ UltraVS™ Neonate Valve. This product is a key component used in a ventriculoperitoneal shunt to aid in the treatment of pediatric patients diagnosed with hydrocephalus. The main objective is to investigate the root cause of both valve and shunt failures and propose potential improvements that may reduce the risk of failure in order to decrease a number of surgeries for pediatrics with this diagnosis. A preliminary hazard analysis, failure mode and effects analysis, and fault tree analysis were used to detect any potential risks and hazards that may cause device failure. Keywords: Hazard and safety analysis


Ventriculoperitoneal shunt

1 Introduction Hydrocephalus is a lifelong condition with which one in every 500 children is born [1] and is considered to be one of the most frequently seen health issues in the pediatric neurosurgical practice [2]. An imbalance in the circulation of cerebrospinal fluid (CSF), a clear fluid that surrounds the brain and spinal cord [1], generates an excessive accumulation of fluid, causing the ventricles of the brain to widen. The buildup of fluid creates harmful pressure on the brain leading to severe brain damage, issues in physical and mental development, or, if left untreated, death [3]. The condition can either be congenital, by genetics or developmental disorders; or acquired due to bleeding in the brain, stroke, infections, or tumors [4]. Irregularity in the cycle process is typically due to the ventricles being blocked, impeding the flow of CSF out of the brain. The disruption is believed to be a symptom of another underlying issue in the nervous system; however, the causes of hydrocephalus are still somewhat unclear [1]. Detection of hydrocephalus can happen during pregnancy or after birth. Symptoms include enlargement of the head, severe headaches, downward deviation of the eyes, vomiting, irritability, seizures, or failure to reach developmental milestones. This is a treatable condition if detected in time. Typical treatment is the implantation of a ventriculoperitoneal (VP) to aid in regulating the flow of CSF, relieving the brain of harmful pressure caused by widened ventricles [1]. The shunting system redirects the flow of CSF from the brain to another area of the body, usually the abdomen in pediatric or neonatal patients, were it can then be reabsorbed by the body.

© Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_61

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VP shunts consist of three main components: a short inflow catheter, a long outflow catheter, and a valve [5]. The inflow catheter is placed in either the front, side, or back of the head, running from the brain to the valve. The valve is placed under the skin, behind the ear and regulates the flow CSF out of the brain. Valves can either be programmable, which can be adjusted without surgical procedure to increase or decrease the flow rate, or nonprogrammable, which is set at a fixed flow rate during surgery [6]. The outflow catheter runs under the skin transporting the fluid from the valve to another area of the body to be reabsorbed. It is estimated that the ratio of shunt revisions to primary shunt placements is 3:1 in pediatric patients [7], bringing the need for the patient to undergo multiple neurological operations. A hazard and safety analysis was performed on a VP shunt for pediatric and neonatal patients that have been diagnosed with hydrocephalus to determine any risks, along with potential corrective actions, with shunt implantation. Time was spent examining a specific model of the valve component of the shunt, the Integra™ UltraVS™ Neonate Valve, more closely identify the root causes of valve malfunction or failure.

1.1

Integra Product Background

The Integra™ UltraVS™ Neonate Valve is the smallest valve developed by Integra Life. Made of silicon, the valve is only 13 mm long and 3.8 mm wide, making this particular device ideal for neonatal and pediatric patients. The device possess a cylindrical shape providing a lower profile to reduce the risk of skin erosion [8]. A Rickham-style reservoir, a channel through which fluids can be removed from or add to, is also incorporated to allow for injecting and CSF sampling if need be [8]. Figure 1 below shows an image of the Integra™ UltraVS™ Neonate Valve.

Fig. 1. Image of the Integra™ UltraVS™ Neonate valve [4]

Integra neonate valves are designed with a miter valve, which naturally opens at a slower rate in response to hydrostatic pressure allowing for a more direct flow path [8]. The fixed pressure, nonprogrammable Integra neonate valve is offered in two size, each available in three pressure ranges: high, medium, and low. Figure 2 provides a graph of pressure (in millimeters of water) versus the flow rate (in milliliters an hour).

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Fig. 2. Graph of pressure versus flow rate of high, medium, and low rage valves [4]

2 Methodology A preliminary hazard analysis (PHA) was used to gain an understanding of general complications that are associated with the placement of a VP shunt in a pediatric patient. This technique is a broad, semi-quantitative study used to identify potential hazards and risks that may occur and lead to severe injury or death [9]. The events are evaluated and ranked on a severity scale of one to four, one being minor and four being catastrophic. From here, potential action plans are created to correct or prevent the hazard from happening. Following the PHA, a failure modes and effects analysis (FMEA) was performed in order to analyze potential reliability problems early in the development cycle and enhance reliability through design of the VP shunt. Its purpose is to identify all potential failure modes, determine their effect on the operation of the shunt, and identify actions to reduce the amount of failures [10]. A fault tree analysis (FTA) was conducted specific to the Integra™ UltraVS™ Neonate Valve. This approach is a top-down, deductive analysis used for defining an undesired event by breaking it down into its immediate and basic causes [11]. The FTA identified all possible scenarios that may result in the patient having to undergo corrective or shunt replacement surgery. The purpose of the analysis was to identify the root cause of a pediatric patient having to undergo multiple procedures caused by factors associated to the valve.

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3 Results Preliminary Hazard Analysis. All six hazards identified were categorized as a hazard category level four. A level four hazard is considered a catastrophic event; meaning that, if not treated immediately or properly, the hazard can lead to patient death or coma. Three of the twelve causes are related to the surgical procedures, two are due to valve performance, and the remaining seven are of natural causes. Figure 3 shows the final results of the PHA.

PRELIMINARY HAZARD ANALYSIS IDENTIFICATION: Medical Device SUBSYSTEM: VP Shunt HAZARD

CAUSE Introduction of pathogens during surgery (i.e. intraoperatively breached gloves)

Infection

Premature or low birth weight

EFFECT

Nausea/Vomiting, fever, loss of appetite, sleepiness, irritability

HAZARD CATEGORY

CORRECTIVE OR PREVENTIVE MEASURES Ensure surgeons wear proper PPE and that all medical instruments have been properly sterilized

4 Frequent neurological assessments and monitoring

Child's own bacterial organisms Post operative shunt leak Child growth Wear on the shunt Components become disengaged

Perastaltic action

Distal catheter is drawn into the abdominal cavity, ventricle catheter is withdrawn from/drawn into the brain, CSF is not being removed from the brain and syptoms of hydrocephalus return, subdural hematoma

4

Schedule regular check-ups to ensure all shunt components are in good, working condition, manufacture a shunting system that has the capability to grow to a certain point Ensure regular bowel movements, increase fiber intake

Constipation

Increased intracranial pressure

Over drainage of CSF

Inaccurate valve

Ventricle(s) collapse

4

Manufacture a programmable valve that can be adjusted without requiring surgery

Under drainage of CSF

Inaccurate valve

Symptoms of hydrocephalus return

4

Manufacture a programmable valve that can be adjusted without requiring surgery

Blockage of distal catheter

Debris introduced during surgery

Impedes flow of CSF through shunt, symptoms of hydrocephlus return

4

Schedule regular check-ups to ensure all shunt components are in good, working condition, ensure proper placement of compnents during surgery

Blockage of ventricle catheter

Improper placement

Impedes flow of CSF through shunt, symptoms of hydrocephlus return

4

Schedule regular check-ups to ensure all shunt components are in good, working condition, ensure proper placement of compnents during surgery

Fig. 3. Preliminary hazard analysis of a ventriculoperitoneal shunt

Failure Modes and Effects Analysis. Figure 4 show the FMEA that was performed on each of the three key components of the shunting system: distal catheter, ventricle catheter and the valve. Each component has the potential to fail, causing the system to malfunction and cause harm to the patient. The analysis shows that each of the catheters impacts the performance of the valve.

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FAILURE MODE AND EFFECTS ANALYSIS Process/System: Ventriculoperitoneal Shunt COMPONENT

Distal Catheter

Ventricle catheter

FUNCTION

Runs from valve to abdomen to drain CSF from the brain

TYPE OF POTENTIAL FAILURE

POTENTIAL EFFECT ON COMPONENT

RELATED COMPONENTS

Blockage

Cannot drain an adecquate amount of CSF to the abdomen

Valve malfunctions

Ensure all surgical debris is removed

Disconnection from valve

Drawn into abdominal cavity

Vavle will not be able to dispense CSF into the abdomen

Schedule check-ups as child grows to ensure all components are in good, working condition

Catheter is cut or torn

Catheter leaks and will not be able to adecquately drain CSF

Valve malfunctions

Blockage

Cannot drain an adecquate amount of CSF to the valve

Valve malfunctions

Ensure catheter has been properly placed

Valve will not be able to transfer CSF to distal catheter

Schedule check-ups as child grows to ensure all components are in good, working condistion

Runs from the brain to the Disconnection from valve valve to drain CSF from the brain

Catheter is cut or torn

Withdrawn from lateral ventricle Lost in lateral ventricle

Catheter leaks and will not be able to adecquately drain CSF

CORRECTIVE ACTION

Do not use instruments to attach catheters Properly inspect tubing if instruments have been used

Avoid use of instruments to attach catheters Valve malfunctions

Properly inspect tubing if instruments have been used Ensure proper lubrication of valve during surgery

Valve adheres to itself

Vavle

Does not properly regulate flow

Impede flow between catheters

Ensure adecquate flow of CSF Pre-lubricate valve during manufacturing process

Regulates flow of CSF from ventricle catheter to distal catheter

Ensure adecuate flow

Valve is not accurate

Does not properly regulate flow

Catheters over drain/ under drain CSF fluid

Schedule regular checkups to ensure components are working properly Design the device to be programmable

Fig. 4. Failure modes and effects analysis of the three components of a ventriculoperitoneal shunt

Fault Tree Analysis. A total of 16 root causes were identified in the FTA shown in Fig. 5, which lead to the outcome of pediatric patients having to endure another neurological operation. Of the 16 causes, six were due to surgical procedures, six were natural causes, and four were associated with malfunction of the valve itself. Some major valve failures include an inaccurate valve and improper lubrication of the valve causing the valve to stick to itself. Both examples of valve malfunction can cause the symptoms of hydrocephalus to return.

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Fig. 5. Fault tree analysis of the Integra™ UltraVS™ Neonate valve

4 Conclusions Improvements to the Integra™ UltraVS™ Neonate Valve have already been made, such as the creation of the cylindrical design to reduce skin erosion and the Rickham-style reservoir for CSF sampling [8]. However, based on the findings of the hazard and safety analysis, there is more to be done to further eliminate hazards, decrease the risk of valve failure, which may cause the return of increased intracranial pressure [12], and reduce the amount of neurological surgeries for pediatric patients diagnosed with hydrocephalus. To reduce the risk of the valve adhering to itself, the device could be pre-lubricated during the manufacturing process prior to being packaged. Lubricating the valve directly before implantation could also reduce the risk of any blockages due to the valve sticking to itself. Offering the device in a programmable model would allow for the adjustment of the pressure settings without having to perform an invasive procedure. This feature would aide in lessening the amount of corrective and replacement shunt surgeries should the valve need a pressure adjustment due to over or under drainage of CSF. 3 to 12% of pediatric patients develop an infection after a VP shunt is implanted, with the greatest risk being within the first three months [13]. Most origins of infection are of natural causes and can be prevented by closely monitoring the patient, especially

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during to first few months after surgery. However, in some instances, infection can be brought about by the introduction of blood borne pathogens. To prevent this, proper personal protective equipment (PPE) should always be worn and all instruments should be fully sterilized. Reinforcing sterile surgical techniques and having regular checkups with patients will aide in reducing infections in the shunt, brain, or abdomen.

References 1. About Hydrocephalus: Pediatric hydrocephalus foundation. http://www.hydrocephaluskids. org/wordpress/?page_id=2. Accessed 02 Dec 2016 2. Pediatric Hydrocephalus: http://www.columbianeurosurgery.org/conditions/pediatric-hydro cephalus/. Accessed 01 Dec 2016 3. Hydrocephalus: MedlinePlus. https://medlineplus.gov/hydrocephalus.html. Accessed 30 Oct 2016 4. Hydrocephalus. http://kidshealth.org/en/parents/hydrocephalus.html. Accessed 20 Oct 2016 5. Shunt Systems. http://www.hydroassoc.org/shunt-systems/. Accessed 06 Dec 2016 6. Health, B.: Brain shunt. http://www.beaumont.edu/neuroscience/neurological-treatmentsservices/brain-shunt/. Accessed 1 Feb 2017 7. McGirt, M.J., Zaas, A., Fuchs, H.E., George, T.M., Kaye, K., Sexton, D.J.: Risk factors for pediatric ventriculoperitoneal shunt infection and predictors of infectious pathogens, 01 April 2003. https://academic.oup.com/cid/article/36/7/858/318528/Risk-Factors-forPediatric-Ventriculoperitoneal. Accessed 3 Jan 2017 8. Integra LifeSciences|Medical Device Company - Medical Technologies. http://www. integralife.com/index.aspx?redir=detailproduct&Product=116&ProductName=Integra%99% 20UltraVS%99%20Valve&ProductLineName=Hydrocephalus% 20Management&ProductLineID=5&PA=neurosurgeon. Accessed 30 Oct 2016 9. Rausand, M.: Preliminary hazard analysis. https://pdfs.semanticscholar.org/97ea/bafa7742 9110191e74d8e47012885ebd00a6.pdf. Accessed 12 Nov 2016 10. Failure Mode Effects Analysis (FMEA). http://asq.org/learn-about-quality/process-analysistools/overview/fmea.html. Accessed 06 Dec 2016 11. Pilot, S.: What is a fault tree analysis? http://asq.org/quality-progress/2002/03/problemsolving/what-is-a-fault-tree-analysis.html. Accessed 3 Jan 2017 12. Nationwide Children’s Hospital. VP Shunt: Care at Home 13. Care and management of the child with shunted hydrocephalus. http://www.medscape.com/ viewarticle/541771_4. Accessed 10 Mar 2017

Investigation of Human Factors Engineering Methods Used in Medical Device Procurement Process Kelly C.D. Lobato ✉ , Carlos H.P. Mello, Ana P.S.S. Almeida, and Rodrigo M.A. Almeida (

)

Universidade Federal de Itajubá, Itajubá, Brazil {klobato,carlos.mello,apssalmeida,rodrigomax}@unifei.edu.br

Abstract. Human Factors Engineering has been used as tool to healthcare insti‐ tutions to do not purchase inefficient, unsafe and poor usability equipment. However, the lack of an impartial source of information leads healthcare organ‐ izations to search ways to assess the vendors’ options. This paper aims to contribute helping healthcare institutions in their procurement process providing ways to get an unbiased source of assessment. For this, the scientific literature was reviewed in order to explore the main human factors engineering methods that have been used. Furthermore, we also intend to identify the challenges in applying these methods. The combination of Human Factors Engineering methods and a multidisciplinary approach were important finds to be highlighted. Using more than one tool provides fuller usability evaluation than using only one method. And, representative decision-making teams ensure that all relevant areas of the organization will be considered during selection. Keywords: Human factors engineering · Medical equipment · Procurement process

1

Introduction

The increasingly usage of advanced technologies in healthcare devices raises the need to reduce equipment errors and use errors [1]. Therefore healthcare institutions need an unbiased source to compare equipment’s performance and help to assess and select a proper, and safe of use, device [1, 2]. Human Factors Engineering (HFE) takes into account human features and limitations to design products, tasks, environments, etc., in order to reach proper usability in their development [3]. When used in procurement process of medical devices, HFE helps healthcare institutions to purchase a safety, effective and efficient equipment [4]. HFE can be applied in different stages of the acquisition process as: requirements specification [4, 5], solution development and acceptance test [6, 7] and vendors bid assessment [1, 3, 8–12]. Introducing a new device in a system that is already in operation requires attention to integration problems that may occur during the implementation [13]. So, it is desirable to

© Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_62

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introduce HFE specialists in procurement process to assist the usability assessment of new devices in order to minimize impacts on final user routine and costs on user training. Literature shows little about the role that HFE plays in purchase decision making [1] even though this approach minimize errors and increases patients safety [4]. Therefore, the scientific literature was reviewed in order to explore the main HFE methods used to assess medical device in procurement processes. The following research questions will guide this paper: 1. Which are the main HFE methods used in medical device purchase? 2. Which difficulties are reported in usage of these methods?

2

Methodology and Data Collection

The systematic review presented on this paper was driven by the PRISMA Statement, from which the four-phase flow diagram [14] is shown in Fig. 1. The purpose of this paper is a qualitative analysis so the last step of the methodology will not be developed.

Fig. 1. Information flow through different phases of a systematic review. Adaptation: [14]

The search was performed on Scopus database on 09/20/2016. The search terms were (“procurement” OR “acquisition”) AND (“human* factor*” OR “usability”) AND (“device* OR “equipment”). These terms were looked up in the following fields: article title, abstract and keywords. The research was limited to articles in English idiom and without date limitation. With these criteria, we found 148 articles that were analyzed as shown in the following sections. It was supported by “Vosviewer” software.

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Results Analysis

3.1 Bibliometric Analysis Initially we verified if there was any duplicated article, and none of it was found. The second step was to remove articles without authors information, resulting in n = 144 articles. With the time distribution it can be noticed that the publication on this subject is increasing (peak in 2013 with 16 publications), representing the interest of researchers and the relevance of the theme (Fig. 2.a). It presents a multidisciplinary feature, as shown Fig. 2.b, and it most of research is healthcare field.

Fig. 2. (a) Publication per year; (b) Publication per field

Authors’ network (Fig. 3.a) shows the main authors found in the research. The size represents the citation quantity. This analysis takes account only authors with at least two papers and one citation. Emphasizing the multidisciplinary feature of the theme, in the network is possible to see that main authors are from different research fields as: aviation (Lintern et al. [15] and Begault and Pittman [16]), healthcare (Garmer et al. [6]) and services (Lazar and Briggs [17]), for example. United States has the major contri‐ bution on the number of citations, followed by Canada and Netherlands (Fig. 3.b).

Fig. 3. (a) Authors network; (b) Countries network

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In order to improve the keywords analysis, we considered “usability”, “human factor*” and “human factor* engineering” as synonyms. As result, Fig. 4 shows relation between HFE and medical field. We can see from the figure that “procurement” is only connected to two human factors technique: “usability test” and “heuristic analysis”.

Fig. 4. Keywords network

Lastly, we classified the articles applied in healthcare field (n = 60) by the purpose of using HFE (Fig. 5). As the main objective of this paper is to verify the application of HFE in medical device procurement process, it will be considered to the systematic review the articles classified as “Comparison” (n = 15), which present comparisons between two or more medical devices. The next section focuses on these. 3.2 Systematic Review Following the phases of Fig. 1, above are presented the 8 eligible articles to systematic review. The causes of 7 of them have been eliminated are presented in Appendix. Keselman et al. [1] mapped a hospital decision making process to acquire infusion pumps by using retrospective interviews and documents analysis. The human factor analysis was made by questionnaires answered by users of the equipment assessed. In order to evaluate the usability level considered by the questionnaires Keselman et al. [1]

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Fig. 5. Articles classification

checked if the 14 heuristics developed by Zhang et al. [18] was taking into consideration in the questions. They discovered that not all of it was considered. Besides that, in their work the authors highlighted the importance of a multidisciplinary team to lead the procurement process. They noticed the clear difference between health professionals standpoint (focus on patient safety) and managers perspective (focus on costs and tech‐ nical safety, as reliability and accuracy). Gandillon [10] analyzed infusion pumps by the number of use error over years of use. Besides that, the authors studied reliability issues, costs and maintenance time to choose the best infusion pump. Gandillon [10] emphasized that measures of usability and reliability could reduce maintenance costs and should be considered in decisions on medical equipment procurement. The author [10] drew the attention to fact that field information about user errors and reliability can improve the relationship between clin‐ ical engineers and medical equipment manufacturers in order to advance medical device design and patient safety. Namshirin, Ibey and Lamsdale [9] participated in the procurement process of smart infusion pumps to a hospital. The committee had representatives from nursing, phar‐ macy, anesthesiology, purchasing, quality and patient safety, biomedical engineering, and human factors. To guarantee a patient-centered selection, were used criteria that covered clinical and financial factors, each one with a specific weigh. Initially, they applied technical evaluation and heuristic analysis with the purpose to reduce the list to up to 4 vendors. The second phase consisted in a deeper evaluation with cognitive walkthroughs, real-time clinical evaluations and usability tests. The authors [9] empha‐ sized that a collaborative approach with a variety of disciplines was fundamental to the success of the procurement process. Ginsburg [4] presented some techniques of human factors used to select infusion pumps. Four criteria were used in the first phase: heuristic analysis, human factors standards established by regulatory bodies, usability rating form and task analysis, and requirement requests in the RFP. The second phase was usability test in different clinical areas. Saleem et al. [5] used rapid ethnographic, gathering information by observation and interviews with end users of Clinical Information Systems (CIS) and Anesthesia Record Keeping (ARK) to gather information about barriers and facilitators factors of different

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vendors of CIS and ARK. Poor usability was one of the barriers found by the authors and main issues were: system customization, data organization, ease of use and effi‐ ciency. So, Saleem et al. [5] recommended that HFE become part of whole procurement process (requirements specification, formative usability assessment, system implemen‐ tation and summative usability assessment) in order to mitigate or even eliminate some barriers identified. Garmer, Ylvén and Karlsson [6] studied the best approach to discover user require‐ ments and use errors for new medical equipment. The case study was developed in two hospitals and the purpose was to buy ventilators used at ICU. Two techniques were analyzed: focus group and usability tests. The authors [6] verified some difference between the techniques: not all aspects found by focal group were noticed by usability test, however the latter identified more detailed requirements; focus groups can gather positive and negative aspect about the equipment, whereas usability test only negative ones. Garmer, Ylvén and Karlsson [6] highlighted that is important that all aspects of the equipment (negatives and positives) are specified as device requirements. The authors [6] also emphasized that final users should participate since early in purchase processes. Hairston et al. [12] used task analysis to assess three wireless electroencephalog‐ raphy (EEG) system over a traditional EEG system. Harrison et al. [11] assessed two infusion pump software. Therefore, the authors observed users interacting with the equipment.

4

Discussion

Regarding research methodology, case study is the most used method by the analyzed articles (Fig. 6.a). Infusion pump was the research object in 5(33%) papers (Fig. 6.b). This can be explained due its importance in the hospital environment, since it is present at different clinical areas (wards, emergency rooms, ICUs, operation room, etc.), while being commonly used as life support. There were found no technique that was consistently more used over the others. Heuristic analysis and usability test were already expected to appear among the methods since they had appeared related to procurement process as shown in Fig. 4. The standard ISO/TR 16982:2014 [19] strongly recommends the use of observations and documents analysis in the acquisition processes. Others methods that were found on the systematic review (Fig. 6.c) are also mentioned by the standard as an adequate technique to assess usability: performance measurement, critical incidents analysis, questionnaires, inter‐ views, collaborative assessment, and specialist assessment. In some cases, the combi‐ nation of methods are used, ensuring a wide evaluation. The studies also report some difficulties in the use of HFE in procurement processes: low purchase committee integration and low representative of final users on decision making [1]; difficulty in acquiring data [10]; few participants [6]; usability tests results, in comparison with others methods, can reveal that users preferences do not always reflect their performance [4]; lacking of standardizing and a multidisciplinary approach to the procurement process [9].

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Fig. 6. Systematic review overview

Therefore, taking account difficulties that can be faced during HFE implementation in a procurement process, the right method to be used should considered all available resources (time, financial, EFH specialists, final users, etc.). The combination of methods can help the responsible for the procurement process to gather more information and perform a better assessment [6].

5

Conclusions

Healthcare institutions are constantly seeking for solutions that are more compatible with the inherent complexity of their tasks. These solutions must help to reduce cognitive load and be easy to use by the staff. Using HFE in the procurement processes can assist healthcare institutions to assess new equipment and proposals in order to prevent future use errors and ensure patient safety, since the equipment purchase. The effective HFE implementation requires a multidisciplinary approach, and the professionals involved with purchase process should be committed to reach usability requirements. However, part of the authors shown that sometimes equipment assessment focuses more on reliability than patient safety. Therefore, there is the importance to have a team with a representative of different institutional areas. This must include one or more final users, once they are the ones that will be using the equipment in a daily basis and may provide a deep knowledge of the risks associated with its usage. On the other hand, it is necessary to adequate the HFE method to available resources. Literature review shown lack of guidelines to procurement of medical devices that make explicit usability requirements to a good product, that way helping the decision making process [2, 9].

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Lastly, agreeing with Hoffman and Cook [13] and Gandillon [10] it is expected that the use of Human Factors Engineering in procurement processes put pressure on medical device manufacturers in order to ensure products development concerning usability requirements, this way regarding patient safety. Acknowledgements. The authors would like to acknowledge financial support of Capes, CNPq, Fapemig and Brazilian Health Ministry.

Appendix: Roll of Eliminated Articles in Systematic Review

Author Bjørn B.; Garde K.; Pedersen B.L.

Title

Infusion pumps and patient safety [Infusionspumperogpatientsik kerhed] Gosbee J.W. Conclusion: You need human factors engineering expertise to see design hazards that are hiding in “plain sight!” Sauro J. Quantifying usability Ivlev I.; Kneppo P.; Bartak M. Multicriteria decision analysis: a multifaceted approach to medical equipment management Burke-Smith A.; Collier J.; A comparison of non-invasive Jones I. imaging modalities: Infrared thermography, spectrophotometric intracutaneous analysis and laser Doppler imaging for the assessment of adult burns Selecting models for a Shaffer R.E.; Janssen L.L. respiratory protection program: What can we learn from the scientific literature? Wang J.; Ding D.; Teodorski Use of assistive technology for E.E.; Mahajan H.P.; cognition among people with Cooper R.A. traumatic brain injury: A survey study

Year

Status

2007

Eliminated: Other Idiom

2004

Eliminated: Editorial

2006 2014

Eliminated: Editorial Eliminated: Literature Review

2015

Eliminated: Technical Comparison

2015

Eliminated: Literature Review

2016

Eliminated: no access

References 1. Keselman, A., Patel, V.L., Johnson, T.R., Zhang, J.: Institutional decision-making to select patient care devices: identifying venues to promote patient safety. J. Biomed. Inform. 36(1– 2), 31–44 (2003) 2. Shaffer, R.E., Janssen, L.L.: Selecting models for a respiratory protection program: what can we learn from the scientific literature? Am. J. Infect. Control 43(2), 127–132 (2015)

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3. ABNT: ABNT NBR IEC 62366:2016 - Produtos para a Saúde - Aplicação da engenharia de usabilidade a produtos para a saúde, p. 124. Associação Brasileira de Normas Técnicas, Rio de Janeiro, Brasil (2016) 4. Ginsburg, G.: Human factors engineering: a tool for medical device evaluation in hospital procurement decision-making. J. Biomed. Inform. 38(3), 213–219 (2005) 5. Saleem, J.J., et al.: Understanding barriers and facilitators to the use of clinical information systems for intensive care units and Anesthesia record keeping: a rapid ethnography. Int. J. Med. Inform. 84(7), 500–511 (2015) 6. Garmer, K., Ylvén, J., Karlsson, I.C.M.: User participation in requirements elicitation comparing focus group interviews and usability tests for eliciting usability requirements for medical equipment: a case study. Int. J. Ind. Ergon. 33(2), 85–98 (2004) 7. Holshouser, E.L.: Human factors engineering teste and evaluation technology. Proc. Hum. Factors Ergon. Soc. Annu. Meet. 18(3), 343–349 (1974) 8. Tainsh, M.A.: Human factors contributions to the acceptance of computer-supported systems. Ergonomics 38(3), 546–557 (1995) 9. Namshirin, P., Ibey, A., Lamsdale, A.: Applying a multidisciplinary approach to the selection, evaluation, and acquisition of smart infusion pumps. J. Med. Biol. Eng. 31(2), 93–98 (2011) 10. Gandillon, R.: Infusion pump reliability and usability. J. Clin. Eng. 38(1), 27–31 (2013) 11. Harrison, M.D., Campos, J.C., Masci, P.: Reusing models and properties in the analysis of similar interactive devices. Innov. Syst. Softw. Eng. 11, 95–111 (2013) 12. Hairston, W.D., et al.: Usability of four commercially-oriented EEG systems. J. Neural Eng. 11(4), 1–14 (2014) 13. Hoffman, J., Cook, C.A.: Designing for usability with COTS: how useful is a style guide? Proc. Hum. Factors Ergon. Soc. 2, 1295–1299 (1998) 14. Moher, D., Liberati, A., Tetzlaff, J., Altman, D.G., P. Grp: Preferred reporting items for systematic reviews and meta-analyses: the PRISMA Statement. Ann. Intern. Med. 151(4), 264–269 (2009) 15. Lintern, G., Roscoe, S.N., Sivier, J.E.: Display principles, control dynamics, and environmental factors in pilot training and transfer. Hum. Factors J. Hum. Factors Ergon. Soc. 32(3), 299–317 (1990) 16. Begault, D.R., Pittman, M.T.: Three-dimensional audio versus head-down traffic alert and collision avoidance system displays. Int. J. Aviat. Psychol. 6(1), 79–93 (1996) 17. Lazar, J., Briggs, I.: Improving services for patrons with print disabilities at public libraries: moving forward to become more inclusive. Adv. Librariansh. 40, 11–32 (2015) 18. Zhang, J., Patel, V.L., Johnson, T.R., Chung, P., Turley, J.P.: Evaluating and predicting patient safety for medical devices with integral information technology. Adv. Patient Saf. 2, 323–336 (2005) 19. ABNT: ABNT ISO/TR 16982:2014 Ergonomia da interação humano-sistema — Métodos de usabilidade que apoiam o projeto centrado no usuário. p. 49. Associação Brasileira de Normas Técnicas, Rio de Janeiro, Brasil (2014)

Usefulness of Skin Punch Tools for Corneal Biopsy Lore Veelaert1 ✉ , Iris Boons1, Anton Carmen1, Julie Engelen1, Nick Janssens1, Clara Devriendt1, Nadia Zakaria2, and Guido De Bruyne1 (

1

)

Department of Product Development, Faculty of Design Sciences, University of Antwerp, Ambtmanstraat 1, 2000 Antwerp, Belgium {Lore.Veelaert,Nadia.Zakaria,Guido.Debruyne}@uantwerpen.be 2 Department of Ophthalmology, Faculty of Medicine and Health Sciences, Visual Optics and Visual Rehabilitation, University of Antwerp, Universiteitsplein 1, Antwerp, Belgium {Iris.Boons,Anton.Carmen,Julie.Engelen,Nick.Janssens, Clara.Devriendt}@student.uantwerpen.be Abstract. Keratitis is a common eye disease where a biopsy is required to deter‐ mine the underlying cause of the inflammation of the cornea. Currently, no stand‐ ardized tool is available for this purpose and corneal scrapings are performed with a scalpel or wide needle, frequently with inconclusive results as too little material is removed for fear of penetration. Consequently, biopsies are rarely performed and a broad-spectrum antibiotic is prescribed, which may result in untoward sequelae. This study investigated the usefulness of a skin punch tool to obtain corneal biopsies as compared to a regular scalpel. The punch tool was more accu‐ rate to reach the objective biopsy radius of 2 mm. Additionally, biopsy duration was about half (88.4 s) when using the punch tool as compared to the use of the scalpel (162.4 s). This research shows a verification method that can be used to evaluate corneal biopsy tools. Keywords: Corneal biopsy · Keratitis · Skin punch tools

1

Introduction

Keratitis, or an inflammation of the cornea (the dome-shaped membrane that covers the iris and the pupil), is a common eye disease in which a biopsy of the cornea is required to determine its underlying cause which can range from infectious causes (including viral, bacterial, fungal, and parasitic), mechanical (contact lens wear), non-infectious (Vitamin A deficiency) [1]. In Western countries between 0.046% and 0.192% of the population is annually diagnosed with keratitis, leading to an estimation of 233 680 to 975 360 corneal biopsies for the European Union [2]. A corneal biopsy is a common procedure in the ophthalmology. Such a biopsy may have several purposes, but is typically used for diagnostic purposes. The main problem in taking a biopsy of the cornea lies in the determination of the actual thickness of the biopsy, and thus the danger to cause even additional damage to the cornea and the eye. The inability to obtain a definitive diagnosis may be related to the depth of the keratitis housing in different layers within the eye where one biopsy contains the whole range of © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_63

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possible keratitis. In fact, seven large groups of keratitis can be distinguished [3]: Superficial punctate keratitis, Ulcerative Keratitis, Viral keratitis, Bacterial keratitis, Fungal keratitis, Amoebic keratitis and Parasitic keratitis. Literature research shows that each of these categories differ from one another on the basis of location, kind and cause, and are defined on certain depths of the cornea. Currently, no standardized tool is available for taking such a biopsy and corneal scrapings are performed with a scalpel or wide bore needle, very often with inconclusive results as too little material is removed for fear of penetration, causing to miss pathogen such as amoebic cysts, fungal hyphae, etc. [4, 5]. Consequently, biopsies are not performed as often and a broad spectrum antibiotic is prescribed, assuming bacterial keratitis [6]. The delay in providing optimal treatment can result in untoward sequelae such as corneal scarring and opacification requiring corneal transplantation. 1.1 Current Treatment Procedure Usually, the treatment is described as follows: when a patient suffers from an infected eye, this can be recognized by the presence of a dendritic ulcer, redness and a charac‐ teristically reduced sensitivity of the cornea leading to loss of its transparency or serious discretion of the vision of the patient. The patient visits the ophthalmologist who usually assumes that the cause is bacterial and thus, prescribes broad-spectrum antibiotics [6]. However, in 36.63% of the patient cases, the cause is not bacterial (but more likely fungal, viral, amoebic or parasitic) preventing the antibiotics to work, and causing more infection to the eye (advanced keratitis) [7]. Subsequently, the next step is to take a surgical biopsy at the hospital, which will then be examined in a laboratory. On the basis of these results, a specific treatment is prescribed, such as anti-viral or anti-parasitic (Acanthamoeba) means. The etiology of most keratitis cases has been obscured by the response of the active elements on the broad-spectrum antibiotics. A corneal scrape is a verified and secure method to confirm a certain microbial cause of an infiltrative keratitis, and to the determine the suscepti‐ bility of specific microbes to anti-microbial agents such as antibiotics [8]. If a proper culture or sample is taken before anti-microbial therapy, a large part of the cases of bacterial or fungal keratitis will have a positive culture, i.e. these test results are decisive. However, problems arise when keratitis is resistant to local therapy, or if there is a progression despite microbiological negative scrapes [9]. These complications are often followed by a variable and inefficient antibiotic therapy resulting in hospitalization. If the treatment of antibiotics is given priority, this often leads to negative results since the concentration of drugs near the infection is not sufficient enough to kill the organisms [10]. In these cases, a corneal biopsy is a necessary tool in the evaluation of the pathogens [11–13]. In the absence of adequate and safe methods for obtaining cornea biopsies, severe keratitis is often followed by penetrating keratoplasty.

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1.2 Current Instruments for Corneal Biopsy No standardized tool is currently available for taking a corneal biopsy, but five poten‐ tially useful biopsy tool can be found: a biopsy punch, a Kimura spatula, a wide needle, a depth knife, eyeprim and a Mictro trephine. A biopsy punch enables surgeons to control the depth and surface area during a biopsy. However, since no horizontal cut is made, no biopsy can be taken of the cornea. This final cut may be performed by a standard scalpel, despite the fact that this tool cannot guarantee the biopsy depth. When using a Kimura spatula or standard scalpel (to retrieve ‘corneal scrapes’), the doctor scrapes the infected are of the eye. This method has little risk of eye damage since the doctor does not cut deeply into the eye. Hence, the disadvantage is that this method has only a small change (approximately 30%) at a sufficiently high-quality biopsy [14]. In case the biopsy does not contain enough cells, it cannot be used in order to make an accurate diagnosis. To take a biopsy with a wide needle, the doctor scrapes the needle over the cornea. Again, a scraping action instead of a cutting action is performed. Since the depth and surface area are not controlled, the disadvantage of this technique is similar to a scalpel, i.e. penetrations of the eye can occur. A depth knife has not been developed specifically for cornea biopsies, and despite the fact that it ensures the depth of the cut (not the surface area), it is too expensive in relation to the few advantages it bring to a minor operation. The eyeprim (Conjunctival impression device) is used to sample superficial epithelial cells of the conjunctiva through pressing a membrane against it, instead of making a cut. This cell biopsy (as opposed to a tissue biopsy) aims to control the morphology of the superficial cells and gives no information about the deeper tissue pathology or micro‐ biology. For example, amoebic cysts, which are usually present in the deeper layers of the cornea, cannot be detected with the eyeprim. Finally, the Micro threpine has been developed in order to take biopsies from damaged corneas. It consists of a cylindrical knife that is driven by a motor. In a study in 1994 [15], 81 biopsies were performed with this tool, resulting in 50 samples and a perforation rate of 1.23%. An overview of existing instruments and their characteristics can be found in Table 1. Within this research, we focus on the use of a standard scalpel and biopsy tool as they are cheap and widely available. Table 1. Comparison of existing instruments for corneal biopsies.

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Research Objective

This study aims to investigate the usefulness of a skin punch tool to obtain corneal biopsies as compared to the use of a scalpel. Which is the accuracy and efficiency of a skin punch tool and scalpel to perform a corneal biopsy?

3

Methods

3.1 Participants Ten untrained test persons aged 20 to 23 (who have only used a scalpel once or twice) were recruited to participate in this research experiment. 3.2 Materials In order to setup this experiment, the following materials were needed: – Preparation: lab coats, safety glasses, rubber gloves; – Test setup: 30 pig cadaver eyes mounted in a holder (to simulate a dilated eye), a regular scalpel, a regular skin punch tool (i.e. a cylindrical knife with a diameter of 2 mm); – Evaluation: petri dishes, two needles for positioning, glass slides, two microscopes, two digital calipers, chronometer, digital camera, Excel. Since it was not feasible to perform the tests on human eyes, pig eyes were used. However, the cornea of a pig eye is thicker than a human’s eye, hence an intended thickness of 2 mm will be used to accomplish the test. In addition, greater test accuracy could be achieved by measuring a 2-mm depth instead of a 0.4 mm depth. The cadaver eyes are up to 72 h old in order to avoid degeneration, and allow to carry out approxi‐ mately ten experiments per eye. To discover which tool is most acceptable and accurate for use, two types of biopsy tools will be tested in this experiment: a regular scalpel and a regular skin punch tool, see Fig. 1.

Fig. 1. Instruments used during the test: regular scalpel (top) and skin punch tool (bottom).

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3.3 Procedure Each participant performed the experiment separately and was required to wear a lab coat, safety glasses and rubber gloves, and if necessary to tie long hairs together with a hair tie, when entering the test room. Each subject was given a personal tray containing one pig eye, a regular scalpel (1), and a biopsy punch tool (2), see Fig. 2 for the test setup.

Fig. 2. Schematic overview of the test setup with scalpel, punch tool, pig eye and petri dishes.

Next, ten test persons were asked to cut three biopsies as accurate as possible with a depth and diameter of 2 mm with each of the two biopsy tools, resulting in six biopsies per participant and thus sixty biopsies in total. The biopsy tools were used in a random‐ ized order through a Latin square design in order to eliminate the learning effect. Each time a biopsy had been taken from the eye, the subject was asked to place the biopsy in a petri dish, as shown in Fig. 3.

Fig. 3. Pictures taken during the experiment of the corneal biopsies.

At the end, the accuracy of the biopsy was quantified by measuring the diameter (shape) and depth of the biopsy using a microscope and digital caliper, see results in Fig. 4. The efficiency of the biopsy was quantified by monitoring the time to perform a

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biopsy with a chronometer. All steps were documented by a digital camera during the test and the results were collected in an Excel file, containing four parameters: the time required to accomplish each test, the shape, the diameter, and the depth of each biopsy.

Fig. 4. Microscopic images of several biopsies taken during the test.

In addition, each participant received a small survey before and after the experiment to examine their existing skills on the one hand, and their findings about both tools on the other hand. During the processing of the results, the mean and average deviation for each tool were calculated in order to conclude which one of the two was most reliable for the depth and the diameter.

4

Results

None of the scalpel biopsies had the intended round shape, in contrast to the punch tool biopsies with only one unsuccessful shape. Then, the mean diameter, depth and time were calculated for each tool, and in order to measure the variability within a set of data, the average deviation was added, showing the average of the absolute deviations from the center for the distribution, see Table 2 for the results and Fig. 5 for a graph. Table 2. Mean diameter, depth and time of the test results (rounded up to 0.1 accuracy). Diameter (mm)

Mean AD

Depth (mm)

Mean AD

Time (s)

Mean AD

Scalpel 2.3 0.9 1.3 0.6 162.4 101.0

Punch tool 2.0 0.2 1.7 0.2 88.4 29.7

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Fig. 5. Average diameter, depth and time of scalpel and punch tool, complemented with the average deviation.

The use of the scalpel resulted in an average diameter of 2.3 mm (AD 0.9 mm). For the punch tool, average diameter was 2.0 mm (AD 0.2 mm). Average punch depth was 1.3 mm (AD 0.6 mm) for the scalpel and 1.7 mm (AD 0.2 mm) for the punch tool. Average duration of a biopsy was 162.4 s (AD 101.0 s) for the scalpel and 88.4 s (AD 29.7 s) for the punch tool. Consequently, the punch tool was a such more accurate to reach the objective biopsy radios of 2 mm. Additionally, the duration of a biopsy was almost the double when using the scalpel as compared to using a punch tool.

5

Discussion

This research paper introduced a method for verifying the accuracy and efficiency of corneal biopsy tools, such that eye doctors can be given an objective evaluation criteria to assess the biopsy sample. Additionally, the method may allow deriving design param‐ eters such that new corneal biopsy tool can be developed and evaluated. Results show a preference for the punch tool in order to achieve an accurate and fast biopsy. However, we must note that more failures occurred with the scalpel than with the punch tool, leading to more missing values in the test results of the former. This may have affected the greater average deviation for diameter, depth and time when using the scalpel. In addition, it must be remarked that even with the use of the punch tool, an additional step was needed with the normal scalpel to make a horizontal cut and retrieve the biopsy from the eye. Finally, with regard to the learning curve, the first test of both tools had a remarkable longer duration than the second and third tests. Moreover, the newness of the eye and the newness of the scalpel itself gave better test results.

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Conclusions

Keratitis, or an inflammation of the cornea, is a common eye disease in which a biopsy of the cornea is required to determine its underlying cause (infectious, mechanical or non-infectious). The main problem in taking such a corneal biopsy lies in the determi‐ nation of the actual thickness of the biopsy, and thus the danger to cause even additional damage to the cornea and the eye. Currently, no standardized tool is available for taking such a biopsy and corneal scrapings are performed with a scalpel or wide bore needle, very often with inconclusive results as too little material is removed for fear of pene‐ tration. This research study aimed to investigate and compare the usefulness of two instru‐ ments that are currently being used to take a corneal biopsy: a standard scalpel and a biopsy punch. In the experiment, pig eyes were used (2 mm depth required) by ten test persons who each made three cuts per instrument. Comparing the depth and diameter means, the punch tool was more accurate to reach the objective biopsy radios of 2 mm. Additionally, the duration of a biopsy was almost the double when using the scalpel (162.4 s) as compared to using a punch tool (88.4 s). To conclude, this research shows a verification method that can be used to evaluate new corneal biopsy tools in future research. Insights of this research can be used to redesign new corneal biopsy tools. Acknowledgments. This paper is the result of a collaborative research between the Department of Ophthalmology (UZA), Centre for Cell Therapy and Regenerative Medicine (Ophthalmology/ Vaxinfectio – UA/UZA) and the Department of Product Development (UA) together with the industrial partner D.O.R.C. Special thanks go to Benedicte Verbraeken, who initiated this research. Additionally, we want to acknowledge Alexis Jacoby, Ingrid Moons and Ni Dhubhgaill Sorcha for their input and feedback and all students contributing to this publication within the course of Applied Research Methods at Product Development, University of Antwerp.

References 1. Gorski, M., Genis, A., Yushvayev, S., Awwad, A., Lazzaro, D.R.: Seasonal variation in the presentation of infectious keratitis. Eye Contact Lens Sci. Clin. Pract. 42(5), 295–297 (2016) 2. Singh, D., Verma, A.: Fungal keratitis: background, pathophysiology, epidemiology. MedScape (2015). http://emedicine.staging.medscape.com/article/1194167-overview. Accessed 08 Mar 2017 3. Verbraeken, B.: Metolice. University of Antwerp, Antwerp (2015) 4. Lee, P., Green, W.R.: Corneal biopsy. Indications, techniques, and a report of a series of 87 cases. Ophthalmology 97(6), 718–721 (1990) 5. Kim, J.-H., Yum, J.-H., Lee, D., Oh, S.-H.: Novel technique of corneal biopsy by using a femtosecond laser in infectious ulcers. Cornea 27(3), 363–365 (2008) 6. Townsend, N., Dunbar, M.T.: The right approach. the diagnosis and the treatment rules for infectious cornea ulcers. Optom. Manag. 49, 22, 25, 42 (2014) 7. Ibrahim, Y., Boase, D., Cree, I.: Incidence of infectious corneal ulcers, Portsmouth study. UK. J. Clin. Exp. Ophthalmol. 6(7), (2012)

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8. Daschner, F.: Leitsätze der Antibiotikatherapie. In: Antibiotika am Krankenbett, pp. 15–18. Springer, Berlin (1996) 9. Wenzel, M., Schrage, N.F.: Diagnostik bei Hornhauterkrankungen. In: Kampik, A., Grehn, F. (eds.) Das äußere Auge. Bücherei des Augenarztes Nr. 137, pp. 37–50 (1996) 10. Callegan, M.C., O’Callaghan, R.J., Hill, J.M.: Pharmacokinetic considerations in the treatment of bacterial keratitis. Clin. Pharmacokinet. 27(2), 129–149 (1994) 11. Friedlaender, M.H.: Corneal biopsy. Int. Ophthalmol. Clin. 28(2), 101–102 (1988) 12. Newton, C., Moore, M.B., Kaufman, H.E.: Corneal biopsy in chronic keratitis. Arch. Ophthalmol. (Chicago, Ill. 1960) 105(4), 577–578 (1987) 13. Whitehouse, G., Reid, K., Hudson, B., Lennox, V.A., Lawless, M.A.: Corneal biopsy in microbial keratitis. Aust. N. Z. J. Ophthalmol. 19(3), 193–196 (1991) 14. Sharma, S., Kunimoto, D.Y., Gopinathan, U., Athmanathan, S., Garg, P., Rao, G.N.: Evaluation of corneal scraping smear examination methods in the diagnosis of bacterial and fungal keratitis: a survey of eight years of laboratory experience. Cornea 21(7), 643–647 (2002) 15. Schrage, N.F., Lorenz, U., von Fischern, T., Reim, M.: The microtrephine. A new diagnostic tool for obtaining corneal biopsies. Arch. Ophthalmol. 105, 577–578 (1994)

Medical Device Design for Improving Orthostatic Hypotension During Supine-to-Stand (STS) Fong-Gong Wu(&) and XIn-An Chen Department of Industrial Design, National Cheng Kung University, Tainan, Taiwan [email protected], [email protected]

Abstract. When healthy people promptly rise from supine to stand (STS), their contraction of leg muscle squeezes blood from the lower limbs to the chest, increasing venous return and contributing to a compensatory increase in blood pressure in order to compensate for gravitational effect. This research aims to design a new device of NMES whose sequence of electric stimulation is bottom-up alternation to simulate natural exercise of SMP. This research illustrates that the innovative Neuromuscular Electrical Stimulation is more efficient at increasing BP and faster activates skeletal muscle pump than the existing one. Furthermore, according to the outcome of Likert scale, the new device is more suitable for scenario of subjects carrying out Supine-to-Stand. It provides subjects with more comfort and convenience. Keywords: Sleep quality


Deep sleep
Mattress design
Pressure paralysis

1 Introduction Among the universal senior population, the causes substantially related with risks of falling contain a history of prior falls, weakness, unsteady gait, confusion and psychoactive medications [1]. The senior population especially has difficulty transferring, and the low capacity for move into and out of a chair or bed is usual in those aged 65 and over, influencing over 6% of community-dwelling senior individuals, and over 60% of nursing home residents [2]. Transferring is regarded as a basic activity of daily life that is a standard part of geriatric assessment. However, as the elderly conduct tasks of diverse postural changes, namely supine-to-stand (STS) and sit-to-stand, the processes are likely to cause orthostatic hypotension. When healthy people promptly rises from STS, their contraction of leg muscles squeezes blood from the lower limbs to the chest, increasing venous return and contributing to a compensatory increase in blood pressure (BP) in order to compensate for gravitational effect [3, 4]. The normal 24-h BP profile was observed especially with low BP in the morning, making patients more vulnerable to syncopal episodes in the morning [5]. OH has been associated with falls, fractures, transient ischemic attacks, syncope, and myocardial infarction [6]. Above all, syncope of OH is a considerably risky symptom which decreases the quality of life of patients [7]. Shibao, Grijalva, Raj, © Springer International Publishing AG 2018 V. Duffy and N. Lightner (eds.), Advances in Human Factors and Ergonomics in Healthcare and Medical Devices, Advances in Intelligent Systems and Computing 590, DOI 10.1007/978-3-319-60483-1_64

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Biaggioni, and Griffin conclude that the most commonly suffered condition in OH patients is syncope [8]. When OH results in dizziness or syncope, it may account for up to 21% of the patients delivered to an emergency room with these symptoms [9, 10]. The syncope due to orthostatic hypotension most commonly occurs in the morning, after meals, sudden postural changes from supine or sit to stand, exertion, and taking some medicine leading to hypotension. Besides, prolonged standing especially in crowded or hot places and presence of autonomic neuropathy or Parkinsonism are also factors in syncope of OH. Particularly, Sarasin et al. show that 31% patients with OH most often feel an episode of syncope coming on during significant orthostatic changes [11]. Therefore, improvement of syncope resulting from OH would result in a positive effect on the living conditions of elder people, helping them live independently. In recent years, contemporary physical medicine is applied in a period of treatment including treatment, prevention, and rehabilitation. At present, the range of therapeutic indications has expanded to include vascular diseases, venous problems, and diseases of lymphatic vessels, focused mainly upon collateral circulation, as well as increasing the efficiency of peripheral vessels [12]. Among methods for treatments, these therapeutic indications, increasing the blood circulation of the lower limbs and BP are included. In addition, presently, there are few device improvements in OH that fit in with the situation of STS. Therefore, this research anticipates finding the approach to the modification of OH in physical medicine, and applying this new method to design an innovative device in accordance with the scenario of STS. The specific objectives of this study are: (1) To develop a new non-pharmacological approach discovered from physiotherapies to improve OH and evaluate the effect of the new method on the improvement of OH. (2) To design a new product by applying the above-mentioned approach and evaluate the effect the product on the improvement of OH, sleeping comfort and other subjective feelings.

2 Methods The experiment was divided into two parts. In the first stage, this study used focus groups and expert interviews to develop a new approach to better OH. Furthermore, the new non-pharmacological intervention was evaluated for its effect on the improvement of OH. In the second stage, according to the result of the first evaluation, this research conducted co-design for development of the new product, and then the final experiment is assessed for the effect on the treatment of OH and subjective feelings.

2.1

Experiment Process

To generate the idea of mattress design, morphological analysis was adopted in this study. The use of morphological analysis could help designer to visualize idea quickly and clearly, and each idea could be combined into more idea [16]. For the mattress idea generation, there would be two axis in the morphological chart, and the X axis was the factors that impact deep sleep, and the Y axis was design features. In the center part of morphological chart, several solutions would be generated based on the two axis.

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For each design feature, one or more idea would be chosen, and the mattress would be the combination of the design features. Development of New Concept of Treatment of OH. At first, this study conducted a focus group for the development of new non-pharmacological concepts. Afterwards, feasibility of these concepts was evaluated by experts. Next, on the basis of these results, this study carried out experiment of evaluation which investigated effects of the new non-pharmacological method on the improvement of OH. Finally, according to the results from the previous experiment, this research analyzed the results and corrected the concept. Development of New Product with the Application of the Above Mentioned Method. In order to develop the product using the previous concept, this research conducted co-design to profit from widespread suggestions. This activity is aimed to overcome the difficulties in the previous experiment of evaluation and make the new product in accordance with scenario of STS; later, create a new product for the treatment of OH. Finally, this study proceeded with the experiment of assessing the new product.

2.2

Study 1-Development of Concept

The aim of this study is to investigate the new non-pharmacological concepts. Through the naturalistic observation, interview, literature review, focus group and expert interviews, the new concept was generated by the end of this stage. Naturalistic observation is often conducted on a small scale and used to generate new ideas because it allows the researcher to study the entire situation. The researcher observes the spontaneous behavior of participants in natural surroundings and records what they see. In this study, observations were conducted to find out the problems the elderly may encounter when they stand up from the chair, in daily life situations. After literature review and interviews with experts on OH and gerontology, this research carried out a focus group study. In the beginning of the focus group, the host introduced the topic of experiment and guided the participants to share the experience or impression of STS. Next, the host explained the cause of OH and lead participants to ideation. Finally, through interaction among the participants, information and solutions are obtained quickly. After integrating the information from the focus group, the main solution is to make the SMP of legs of supine patients simulate normal walking conditions, which is repeated contraction in bottom-up order. Because the calf muscle pump of the lower extremity comprises the largest peripheral muscle pump in the body and its function is considered essential for maintaining healthy venous flow [13, 14], there are a lot of researches about the application of NMES whose self-adhering electrodes are set on the calf muscle. Prevention of venous stasis often utilizes NMES whose neuro stimulation electrodes were placed over the soleus motor points on the subject’s calf (Fig. 1) [15, 16]. Both of their results are efficient to increase venous flow by activating SMP with NMES. Most of the existing settings of self-adhering electrodes of NMES concurrently provide electrical discharge for subjects; however, the physiological motion of SMP in calf

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facilitates a sequence of un-folding and folding of venous valves. The venous valves don’t simultaneously operate; contrarily, their actions are in bottom-up order. Therefore, this research innovates a new device of NMES whose sequence of electric stimulation is bottom-up alternation to simulate natural exercise of SMP. In addition to put the self-adhering electrodes on soleus motorpoints of calf, this device additionally put them on the above of ankle (Fig. 3.5) because stimulating muscle above the ankle with electric shock brings about obviously repeated plantar flexions like walking behavior which promotes venous return [17]. As a result, this research compares simultaneous and alter-native electric stimulations.

Fig. 1. Soleus motorpoints and innovative method

According to the preliminary investigation, considering the feasibility and information obtained from literature review, this study adopts NMES to improve OH. This study supposed that the alternative electric discharge of self-adhering electrodes of NMES in bottom-up order can improve the syncope of OH and is more efficient than simultaneous electric discharge. The innovative wearable NMES device is reformed from beurer - EM 41 - Digital electronic muscle stimulation unit. Notably, its wires are combined with relays and Arduino which makes the device alternately discharge electricity. An experimental study with 5 participants (1 male) was conducted. It lasted about 2 h per person. The average age was 72.6 years (standard deviation (SD) = 6.56) with an age range of 68–82 years. All participants were retired elders and had prior experience with the syncope of OH. Subjects are free from the experience of cardiovascular operation, installation of pacemaker, and wounds in the legs. The experiment system and environment are shown on Fig. 3.7. The hardware consists of a bed, a digital blood pressure monitor (Microlife BP 3MS1-4KT), a PowerLab combining with a finger pulse sensor and a Wii Balance Board (WBB), a personal computer (PC) and a camera. The software utilized is Lab Chart v7.3.7 which is cooperated with PowerLab, and acquires and analyzes data. The finger pulse sensor and sphygmomanometer detect the participant’s heart rate (HR) and blood pressure (BP) respectively during the experiment. A participant stands up from the bed on the WBB, while the PowerLab acquires the trajectory of the center of pressure (COP).

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The camera is used to record the whole experiment. The HR, BP, COP data, and video are used to evaluate the relationships between stability and effect of the device. There are three cases of experiment that every participant takes part in, namely case (a), case (b) and case (c). (1) Without device: Subjects are without NMES device. It is a control group. (2) With simultaneous electrical discharge: They wear NMES equipment with simultaneous electric discharge and self-adhering electrodes with a traditional arrangement for improving venous stasis (Fig. 2). (3) With alternate electrical discharge: They outfit with a NMES device which alternatively discharge electricity in bottom-up order and a new arrangement to paste self-adhering electrodes on legs (Fig. 2).

Fig. 2. Processes of case (a), (b) and (c)

The entire experiment is an hour and a half. Every experiment proceeds for 19 min and is recorded by a video camera. Between each case, the subject has 15 min to rest. At the beginning, the subject lies down on the bed for fifteen minutes. At the 11th minute, PowerLab starts to measure the HR of the subject. At the 15th minute, the subject is asked to stand up from the bed directly, so measurement of COP is operated at the 14th minute. Subject wakes up at the 11th minute. Between the 11th and the 18th minute, BP monitor gauges the BP of the subject once each minute. A total of eight measurements of BP were taken. For the subject in the cases (b) and (c) with wearable device, the NMES devices is turned on at the 12th minute and off at the 15th minute. They showed similar pulse duration of 300 ls and a pulse frequency of 35 Hz. For evaluation purposes the following dependent measures were collected: (1) Objective data resulting from the test scenario: BP, HRV, and COP (2) Subjective data resulting from the feedback: Likert scale.

2.3

Summary

COP. There are no statistically significant differences in the RM ANOVA result of COP. However, a paired-samples t-test was conducted to compare trajectory of COP after STS in case (a) and (c). There are statistically significant differences, at the 0.05 significance level, in case (a) without device to case (c) with designed device for

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trajectory of COP after STS, t (4) = −2.72, p = 0.03. Its p value is