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The Wiley Handbook of Healthcare Treatment Engagement: Theory, Research, and Clinical Practice
 1119129494, 9781119129493

Table of contents :
Cover
The Wiley Handbook of
Healthcare Treatment
Engagement:

Theory, Research, and Clinical Practice
© 2020
Contents
Foreword
Preface
Notes on Authors
Notes on Contributors
Acknowledgments
Introduction
Section I: Background
1 Treatment Engagement and Adherence.
A Review of the Literature
2 What Do Patients Want? Patient
Satisfaction and Treatment
Engagement
3 Values‐based Practice and Patient
Engagement.

Linking Science with People
4 Informed Consent and the Law.

From Patient Compliance to Patient
Engagement?
5 Assessing, Measuring, and
Monitoring Treatment
Engagement
Section II:
Understanding Treatment Engagement
6 Addressing the Challenges
of Neurocognitive Impairment (NCI) on Treatment Engagement
7 Self‐determination Theory and
Autonomy Support to Change
Healthcare Behavior
8 Attachment Theory,
the Therapeutic Alliance,
and Treatment Engagement
9 Clinical Case Formulation
of Suboptimal Engagement
10 The Contribution of Beliefs
to Treatment Engagement
Section III:
Practical Approaches to Enhance Engagement
11 Medication and Treatment Beliefs as Determinants of Treatment
Engagement
12 Cognitive Behavioral and eHealth
Approaches to Promote
Engagement in Treatment
13 Enhancing Treatment Engagement
Through Motivational
Interviewing
14 Positive Approaches to Promote
and Support Changes
in Health Behavior
15 Communication Skills to Engage
Patients in Treatment
16 Understanding Some
Psychodynamic Factors Involved
in Suboptimal Engagement
17 Enhancing Wellbeing and
Motivation for Staff Working
with Patients Who Have
Inconsistent or Challenging
Engagement in Services
Section IV:
Treatment Engagement in Specific Client Groups
18 Engaging Patients from Diverse Backgrounds in Healthcare
Treatment
19 Enhancing Treatment Adherence
in Young People with
Chronic Diseases
20 Enhancing Treatment Engagement
in Older Adults
21 Treatment Engagement and
People with Intellectual Disability
22 Promoting and Maintaining
Engagement in Substance
Abuse Treatment
23 Working with People with Mental
Health Difficulties to Improve
Adherence to Medication
24 Engaging Socially Excluded
Individuals and Communities
in Healthcare
25 Understanding and Overcoming
Barriers to Treatment Engagement
in Lower‐income Countries
Section V:
Designing and Delivering Services to Optimize Patient Engagement
26 Treatment Engagement. The Experience of Users of Health Services
27 Recovery from Ill Health
from an Occupational Perspective
28 Achieving Patient Engagement
Through Shared Decision‐making
29 Optimizing Service Delivery
to Enhance Treatment
Engagement
30 Patient Engagement in Treatment
in an Information Age
31 Governing by Risk, or Why
Interventions to Improve
Health Fail
Afterword,

Future Directions
Index

Citation preview

The Wiley Handbook of Healthcare Treatment Engagement

The Wiley Handbook of Healthcare Treatment Engagement Theory, Research, and Clinical Practice Edited by

Andrew Hadler Stephen Sutton and Lars Osterberg

This edition first published 2020 © 2020 John Wiley & Sons Ltd All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise, except as permitted by law. Advice on how to obtain permission to reuse material from this title is available at http://www.wiley.com/go/permissions. The right of Andrew Hadler, Stephen Sutton, and Lars Osterberg to be identified as the authors of this editorial material in this work has been asserted in accordance with law. Registered Offices John Wiley & Sons, Inc., 111 River Street, Hoboken, NJ 07030, USA John Wiley & Sons Ltd, The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK Editorial Office The Atrium, Southern Gate, Chichester, West Sussex, PO19 8SQ, UK For details of our global editorial offices, customer services, and more information about Wiley products visit us at www.wiley.com. Wiley also publishes its books in a variety of electronic formats and by print‐on‐demand. Some content that appears in standard print versions of this book may not be available in other formats. Limit of Liability/Disclaimer of Warranty While the publisher and authors have used their best efforts in preparing this work, they make no representations or warranties with respect to the accuracy or completeness of the contents of this work and specifically disclaim all warranties, including without limitation any implied warranties of merchantability or fitness for a particular purpose. No warranty may be created or extended by sales representatives, written sales materials or promotional statements for this work. The fact that an organization, website, or product is referred to in this work as a citation and/or potential source of further information does not mean that the publisher and authors endorse the information or services the organization, website, or product may provide or recommendations it may make. This work is sold with the understanding that the publisher is not engaged in rendering professional services. The advice and strategies contained herein may not be suitable for your situation. You should consult with a specialist where appropriate. Further, readers should be aware that websites listed in this work may have changed or disappeared between when this work was written and when it is read. Neither the publisher nor authors shall be liable for any loss of profit or any other commercial damages, including but not limited to special, incidental, consequential, or other damages. Library of Congress Cataloging‐in‐Publication Data Names: Hadler, Andrew, 1975– editor. | Sutton, Stephen, editor. | Osterberg, Lars, editor. Title: The Wiley handbook of healthcare treatment engagement : theory, research, and clinical practice / edited by Andrew Hadler, Stephen Sutton, and Lars Osterberg. Other titles: Handbook of healthcare treatment engagement Description: Hoboken, NJ : Wiley-Blackwell, 2020. | Includes bibliographical references and index. Identifiers: LCCN 2019042668 (print) | LCCN 2019042669 (ebook) | ISBN 9781119129493 (hardback) | ISBN 9781119129523 (adobe pdf) | ISBN 9781119129516 (epub) Subjects: MESH: Patient Participation | Professional-Patient Relations | Communication Classification: LCC R727.3 (print) | LCC R727.3 (ebook) | NLM W 85 | DDC 610.69/6–dc23 LC record available at https://lccn.loc.gov/2019042668 LC ebook record available at https://lccn.loc.gov/2019042669 Cover Design: Wiley Cover Image: © Mathilde Le Coutour Set in 10/12pt Galliard by SPi Global, Pondicherry, India

10 9 8 7 6 5 4 3 2 1

Contents

Foreword viii Preface x Notes on Authors xiii Notes on Contributors xiv Acknowledgments xxv Introduction 1 Section I Background

15

1 Treatment Engagement and Adherence: A Review of the Literature Christiana O. Oshotse, Hayden Barry Bosworth, and Leah L. Zullig

17

2 What Do Patients Want? Patient Satisfaction and Treatment Engagement Ann E. Webb and Robin E. Gearing

33

3 Values‐based Practice and Patient Engagement: Linking Science with People Bill (K.W.M.) Fulford

58

4 Informed Consent and the Law: From Patient Compliance to Patient Engagement? Richard Huxtable

75

5 Assessing, Measuring, and Monitoring Treatment Engagement Donald E. Morisky and Chia‐Hsin Emily Cheng Section II  Understanding Treatment Engagement 6 Addressing the Challenges of Neurocognitive Impairment (NCI) on Treatment Engagement Roman Shrestha, Pramila Karki, and Michael Copenhaver

92 109 111

7 Self‐determination Theory and Autonomy Support to Change Healthcare Behavior 141 Martin S. Hagger and Cleo Protogerou

vi

Contents

8 Attachment Theory, the Therapeutic Alliance, and  Treatment Engagement Katherine Berry and Adam Danquah 9 Clinical Case Formulation of Suboptimal Engagement Lawrence Jones and Sunita Guha

159 172

10 The Contribution of Beliefs to Treatment Engagement Vivian Auyeung, Lyndsay D. Hughes, and John A. Weinman

188

Section III  Practical Approaches to Enhance Engagement

203

11 Medication and Treatment Beliefs as Determinants of Treatment Engagement Rob Horne

205

12 Cognitive Behavioral and eHealth Approaches to Promote Engagement in Treatment 223 M. Bryant Howren, Anne I. Roche, and Alan J. Christensen 13 Enhancing Treatment Engagement Through Motivational Interviewing Stanley R. Steindl and Jason P. Connor

243

14 Positive Approaches to Promote and Support Changes in Health Behavior Emily G. Lattie and Anne Cohen

259

15 Communication Skills to Engage Patients in Treatment Mollie A. Ruben, Danielle Blanch‐Hartigan, and Judith A. Hall

274

16 Understanding Some Psychodynamic Factors Involved in Suboptimal Engagement 297 Geoffrey P. Taylor and Deborah L. Cabaniss 17 Enhancing Wellbeing and Motivation for Staff Working with Patients Who Have Inconsistent or Challenging Engagement in Services Alex Lord Section IV  Treatment Engagement in Specific Client Groups 18 Engaging Patients from Diverse Backgrounds in Healthcare Treatment Aswita Tan‐McGrory, Andrea O. Madu, Karey S. Kenst, and Joseph R. Betancourt 19 Enhancing Treatment Adherence in Young People with Chronic Diseases Michael A. Rapoff and Ali Calkins‐Smith 20 Enhancing Treatment Engagement in Older Adults Jo Anne Sirey and Patricia Marino

313 335 337

354 365

Contents

vii

21 Treatment Engagement and People with Intellectual Disability Roger J. Stancliffe, Seeta Durvasula, Nathan J. Wilson, and Peter Lewis

381

22 Promoting and Maintaining Engagement in Substance Abuse Treatment Nikolaj Kunøe

399

23 Working with People with Mental Health Difficulties to Improve Adherence to Medication Thomas R.E. Barnes and Peter M. Haddad

430

24 Engaging Socially Excluded Individuals and  Communities in Healthcare Jed Boardman and David Morris

455

25 Understanding and Overcoming Barriers to Treatment Engagement in Lower‐income Countries Andrew L. Ellner, Jessica L. Alpert, Chris Desmond, and Ashwin Vasan

477

Section V Designing and Delivering Services to Optimize Patient Engagement 503 26 Treatment Engagement: The Experience of Users of Health Services Dolly Sen

505

27 Recovery from Ill Health from an Occupational Perspective Wendy Bryant and Maggie Winchcombe

515

28 Achieving Patient Engagement Through Shared Decision‐making Paul Barr, Glyn Elwyn, and Isabelle Scholl

531

29 Optimizing Service Delivery to Enhance Treatment Engagement Sharon Lawn

551

30 Patient Engagement in Treatment in an Information Age Fiona Stevenson and Maureen Seguin

568

31 Governing by Risk, or Why Interventions to Improve Health Fail Paul Crawshaw

582

Afterword: Future Directions 597 Index602

Foreword

A chasm separates what we know from sound scientific research to be potentially ­beneficial for healthcare and what we achieve for people with health disorders. This is a very complicated problem, with many known and unknown contributors. Arguably, the most important general contributor is a lack of acceptance by people of the prescriptions of practitioners, especially for treatments that are to be self‐administered, such as medicines, exercise, and diet. We have a considerable knowledge now that can be applied, but we also need new thinking and new knowledge to bridge the chasm. The contributors to this book combine expertise and evidence to advance this mission, especially in relation to patient engagement in recommendations for their healthcare, and also for engaging practitioners in this process. People not following medical advice for self‐administered healthcare treatments has no doubt been happening since the beginning of human existence – and this shows no sign of abating. Initially, it is fair to say that this trait provides some protection against prescribed treatments that are worthless or cause more harm than good. There are many such prescriptions and treatments to this day, but current times are different in at least one important way. Clinicians now deal with many health conditions for which efficacious treatments have been validated, and this list grows daily. What was once justifiable self‐defense against quackery, and is still justifiable for many healthcare treatments, has now also become a major tragedy of our times. Simple algebra illustrates the problem. A 25% relative risk reduction in patient‐ important health outcomes is a moderately large effect for the efficacy of a new treatment compared with other treatments, or “usual care,” but typically no more than 50% of practitioners will prescribe new treatments within a generation of their validation and no more than 50% of people who could benefit will adhere to the intervention if prescribed. Thus, a net benefit is achieved of no more than (25% x 50% x 50% =) 6% at best. For example, for many people with atrial fibrillation oral anticoagulants can reduce the risk of stroke by over 50%, but surveys show that clinicians prescribe anticoagulants for only about 50% of eligible patients, and of patients for whom anticoagulants are prescribed only about 40% take them as intended, whittling a 50% relative benefit down to about 10%. About 5% of middle‐aged people have atrial fibrillation and 3% of these will suffer a stroke over a 15‐year period as a result of the atrial fibrillation. Anticoagulation, fully applied, would reduce the attributable stroke rate to 1.5% or less, but at current uptake rates only to 2.7%. Extrapolated worldwide, annually, this is the difference of over 86 000 strokes averted per year versus over 17 000 strokes averted per year.

Foreword

ix

Overcoming this problem is inherently complex, as it requires simultaneous solutions for both practitioner and patient actions to gain traction. For instance, increasing appropriate prescribing from 50% to 75%, without increasing patient adherence, would increase the benefit to only 15%, whereas increasing both prescribing and adherence to 75% would increase the net benefit to 28%. To make matters worse, increasing either practitioner or patient acceptance for unvalidated or discredited interventions would have adverse effects without benefits. At present, efficiently, consistently, and affordably resolving this problem is beyond our understanding and reach. The knowledge–practice gap exists for virtually all health interventions. The loss that it causes for return on investment in research is staggering and assuredly leads to more deaths and suffering than any natural disaster in human history. I first became familiar with “patient compliance” (as it was referred to at the time) when I was a graduate student working with Professor David Sackett at McMaster University in 1971. At that time, hypertension was one of the first chronic medical conditions for which efficacious treatments had been discovered and the problem of patient compliance had been documented as a barrier to blood pressure control through a growing number of observational studies. The more I looked into the topic, the more fascinated, mystified, and horrified I became. What was the point of doing healthcare research if so few practitioners and patients “bought in”? What validated remedies for the problem existed? What approaches were promising but inadequately tested? At the time “patient education” based on education theory and “cues and rewards” based on behavioral psychology were in fashion, but there were no randomized trials of any intervention showing effects on patient‐important outcomes. Today, thousands of studies later, including hundreds of trials, we have documented the lack of efficacy of many interventions (including most forms of patient education), and the efficacy of a few interventions, but none with a substantive effect on patient‐important outcomes or the simplicity that would allow widespread implementation (Nieuwlaat et al. 2014). Clearly, we need new thinking and insights into this pervasive problem! The editors, Andrew Hadler, Stephen Sutton, and Lars Osterberg, have assembled an impressive, transdisciplinary team of experts from around the world, working under the theme of a fresh perspective, “patient engagement.” The authors comprehensively review what we know, what we can apply now, what is promising, but needs further testing, or refining for practical application, and where the frontier is for creating new knowledge. All clinicians and as many scientists as possible are needed for traveling this last mile for getting healthcare knowledge into practice. R. Brian Haynes MD, PhD Professor Emeritus, McMaster University

Reference Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, Agoritsas T, Mistry N, Iorio A, Jack S, Sivaramalingam B, Iserman E, Mustafa RA, Jedraszewski D, Cotoi C, Haynes RB. Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews 2014, Issue 2. Art. No.: CD000011. DOI:https://doi. org/10.1002/14651858.CD000011.pub4

Preface

This volume is devoted to the topic of patient engagement in healthcare treatment. This is a realm which has been overlooked in the great majority of medical texts, and in clinical practice it is all too often taken for granted. Following the assumptions implicit in the “sick role,” the medical model, and what is widely understood as the “traditional medical interaction,” it is expected that a person who is unwell, or is concerned by their health, will rationally follow the advice and treatment recommendations as agreed with their professional health provider. In fact, the observed reality of human behavior in relation to treatment adherence and health behavior change commonly runs contrary to expectations, limiting the effectiveness of treatment in the majority of healthcare settings. Such conventional medical wisdom also typically overlooks how health and wellbeing varies across different groups and is shaped by social factors, such as poverty. This book is intended to support healthcare practitioners and service planners in the immensely varied field of healthcare practice, improving care by working with patients, helping them achieve the positive changes that they wish to make in order to improve their health and quality of life. The origins of this book began with a conference organized by one of the editors in 2010. Following that meeting, a discussion took place between the contributors, who realized that it appeared that a book did not exist which would bring together and explore the material and themes which had been discussed. During early development, it became clear to the editorial panel that the scope of such a volume would be considerable. In order to offer the reader a robust understanding applicable to the needs of a variety of patients accessing care, it would be necessary to describe methods which could enhance communication and patient engagement in treatment across different clinical specialties, and also provide an introduction to fields such as the ethical and legal aspects of the subject. Resources dedicated to service design and delivery would be required. Benefitting from the support of the commissioning editors at Wiley, the co‐editors collaborated to bring the vision closer to completion. After many hundreds of discussions, decisions, and dilemmas accompanying the contribution of the chapter authors, the current volume has become a reality. The editors are a psychiatrist with experience of practice in physical medicine, a physician with an interest in health behavior and medical education, and a professor of behavioral medicine with experience of researching health behavior and designing population health interventions. We share a passionate interest in the topic of patient

Preface

xi

engagement in treatment and have experience in putting into practice the methods described in this volume. We have repeatedly witnessed situations in which the behavior of healthcare service users has differed from the expectations of those delivering care and have observed the increased demand on health services that has arisen as a result of poorly managed chronic health conditions. Our intention has been to create the volume which practitioners would seek to use in order to enhance their current clinical practice, as well as informing the development of health‐care services. We have made no assumptions of prior expertise in the various topics on the part of the reader. We have thought of the reader as any healthcare practitioner, trainee, or student, from any discipline or field of practice in health care, who can expect to speak to patients or their caregivers regarding health, wellbeing, healthcare treatment or health behavior, as well as any person involved in delivering, planning or setting direction in health services or systems. The volume has been prepared with a worldwide audience in mind. The contents of the volume reflect that few healthcare practitioners will practice alone and are likely to work in multidisciplinary clinical teams within complex health systems, anticipating the support which may be required on an organizational level to support service delivery attuned to the theories, clinical methods, and service developments which are described. Likewise, recipients of care do not exist in isolation; the significant role of relationships with caregivers is acknowledged, as well as the influence of social factors upon access to care and health outcomes. Treatment itself is recognized in the context of potentially complex needs and co‐morbidities, often taking the form of a package of care to address these needs. We intend that the approach offered by this volume will leave the reader well placed to respond to all such eventualities. An exploration of the term patient engagement in healthcare treatment, chosen as the subject for this volume, is included in the introduction. In brief, we found widespread reference to the concept of patient engagement in treatment in various fields and considered the term better suited to promote consideration of the complex interplay of factors which may impact on health outcomes in individual clinical cases than suggested by terms such as “adherence” alone. We have sought to bring together in a single volume the considerable body of literature which provides eloquent, evidence‐based explanations of human behavior in relation to health and treatment as well as the beliefs, assumptions, emotional processes, social factors, and qualities of treatment itself which may underlie and determine this behavior. In spite of the immense significance of this field, this knowledge is not yet consistently in the hands of either those delivering care or those planning services. We have adopted an interdisciplinary approach to deliver a comprehensive resource, which will support the task of delivering the most effective clinical interventions, in a manner with which patients are more likely to meaningfully engage. In addition to providing a resource of factual knowledge, we have encouraged a critical and reflective stance in the reader, supporting those who seek to change the way they see and understand this field of practice. The material is presented in a user‐friendly format. The reader will find a logical progression of the topics through the overall structure of the volume, divided into five parts; a more detailed introduction to the structure of the book is offered in the introduction. Each chapter offers “key points,” an introduction, and conclusion, as well as, where appropriate, clinical vignettes to place the material in context. The

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Preface

chapter authors have been chosen by virtue of their expertise and have focused on principles and factors with relevance across a variety of settings, rather than on specific behaviors, treatments, or health conditions. A commentary is offered between chapters to draw connections and distinctions between the contents across the volume. There are compelling reasons to study this fascinating topic and for far greater attention to be devoted to it than is the case at the present time. Bringing into existence a new book has not been without its challenges; this first edition embodies our best efforts to present the volume that would represent this field and be of most use to the reader. We recognize that there will be continuing developments in this field during the life of this edition as well as other limitations, for example those arising from our perspective and experience of the topic as well as the experience of the authors. We recognize that it will be in healthcare practice that the volume will be put to the test and that, in this way, the volume will be improved for future editions; we will be pleased to hear from our readers of their experiences of bringing the material into the real world of practice.

Notes on Authors

Andrew Hadler is a Consultant Forensic Psychiatrist, working with people living with mental health problems who commonly have complex patterns of engagement in treatment. He is appointed as Honorary Lecturer at Brighton and Sussex Medical School, teaching on the topic of patient engagement in healthcare treatment, and has conducted research exploring the experiences of engagement in treatment amongst people living with mental health problems. He has received a national award for innovation from the NHS Institute for Innovation and Improvement, is a member of the Royal College of Psychiatrists and is an Editorial Board member of the journal, the BJPsych Bulletin. Prof Stephen Sutton BA MSc Phd CPsychol is Professor of Behavioural Science and Director of Research in the Institute of Public Health, University of Cambridge. He studied social psychology at the London School of Economics and computer science at City University. He received his PhD from the University of London in 1981 for research on the effects of fear appeals. Before moving to Cambridge, he held posts at the Institute of Psychiatry and University College London. His current research programme focuses on developing and evaluating interventions to change behaviours including smoking, physical activity, diet and medication adherence. He is Visiting Professor at the University of Bergen, Norway, and University College London. Lars Osterberg, MD, MPH Associate Professor of Medicine, Stanford School of Medicine is a recognized leader in medical education. His research has focused on communication skills, adherence to treatment and humanistic practice. He has been invited to present on medical education topics at national conferences and invited to teach bedside medicine or provide faculty development nationally and internationally on topics of medical education and adherence to treatment. In 2007 he started the Educators for CARE program, a learning community of Stanford Medical School that provides structured mentoring for all medical students in the Stanford School of Medicine, and he is co-director of the Stanford School of Medicine Teaching and Mentoring Academy.

Notes on Contributors

Jessica L. Alpert is a case writer and researcher at the Harvard Medical School Center for Primary Care, Boston, Massachusetts. Vivian Auyeung is Senior Lecturer in Medicines Use at the Institute of Pharmaceutical Science, King’s College London. Her research aims to integrate the disciplines of health psychology with pharmacy; specifically, tackling the problem of medicines non‐ adherence by designing and testing scalable and sustainable pharmacy‐led solutions based on psychological theories. Thomas R.E. Barnes is Emeritus Professor of Clinical Psychiatry at Imperial College, London, and joint head of the Prescribing Observatory for Mental Health at the Royal College of Psychiatrists. His research in schizophrenia and its treatment has generated over 300 publications. He is a co‐editor of The Maudsley Prescribing Guidelines in Psychiatry and has been a member of schizophrenia treatment guideline development groups for both the National Institute for Health and Care Excellence and the British Association for Psychopharmacology. Paul Barr is a member of Faculty at the Dartmouth Institute for Health Policy & Clinical Practice, Hanover, New Hampshire, where he leads the “Open Recordings” research group. He is a health‐services researcher, promoting greater transparency in healthcare and working at the intersections of technology, patient‐ and family‐ centered communication and shared decision‐making. He is the recipient of the Gordon and Betty Moore Patient and Family Engagement Award. Paul received his PhD (Public Health) and BSc (Psychology) from Queen’s University, Belfast, Ireland, and received an MSc in Public Health (Health Services Research stream) from the London School of Hygiene and Tropical Medicine, London UK. Katherine Berry is a senior lecturer and clinical psychologist who is based at the University of Manchester. Her main area of expertise is attachment theory and therapeutic relationships in people with a diagnosis of psychosis. She currently works on the Manchester Clinical Psychology Training Programme and as a clinical psychologist in mental health rehabilitation.

Notes on Contributors

xv

Joseph R. Betancourt MD MPH is the founder and director of the Disparities Solutions Center, Senior Scientist at the Mongan Institute for Health Policy at Massachusetts General Hospital, and an Associate Professor of Medicine at Harvard Medical School. Dr. Betancourt has authored peer‐reviewed articles on topics including racial/ethnic disparities in health and healthcare; public health; cross‐cultural care and education; clinical decision‐making; ethics; workforce diversity; and the impact of language barriers on healthcare. Danielle Blanch‐Hartigan PhD MPH is Assistant Professor of Health Studies in the Department of Natural and Applied Sciences and Director of the Health Thought Leadership Network at Bentley University in Waltham, Massachusetts. Danielle holds a PhD in Psychology from Northeastern University, a Masters in Public Health from Harvard School of Public Health and completed postdoctoral training as a Cancer Prevention Fellow in the Behavioral Research Program and Office of Cancer Survivorship at the National Cancer Institute. Her interdisciplinary research in psychology and public health aims to understand patient perceptions and improve the patient‐care experience. Dr. Blanch‐Hartigan has published over 45 articles in peer‐ reviewed journals across psychology, health communication, and medicine. Jed Boardman is a psychiatrist and Senior Lecturer in Social Psychiatry at the Institute of Psychiatry, Psychology, and Neuroscience. He is Senior Policy Adviser at the Centre for Mental Health and lead for Social Inclusion at the Royal College of Psychiatrists where he advises on employment and welfare benefit matters. He chaired the Royal College of Psychiatrists Social Inclusion Scoping Group. Hayden Barry Bosworth is the Associate Director of the Center for Health Services Research in Primary Care at the Durham Veterans Affairs Healthcare System. He is also a Professor of Medicine, Psychiatry, Population Health Science, and Nursing at Duke University Medical Center. His research provides knowledge for improving patients’ treatment adherence and self‐management in chronic care. Dr. Bosworth has authored over 280 peer‐reviewed publications, over 70 of which address treatment adherence. Wendy Bryant, is Senior Lecturer and Subject Lead for Occupational Therapy at the University of Essex. Wendy has practiced as an occupational therapist since 1984 in a wide range of UK settings including social care. Her research has been focused on collaborating with service users and providers, using participatory and creative methods. Deborah L. Cabaniss MD is Professor of Clinical Psychiatry and Associate Director of Residency Training in the Columbia University Department of Psychiatry. In that role she teaches psychodynamic psychotherapy to residents and coordinates teaching and supervising of psychotherapy in the residency. She is the winner of numerous teaching awards and is a Training and Supervising Analyst at the Columbia University Center for Psychoanalytic Training and Research. Her books, Psychodynamic Psychotherapy: A Clinical Manual and Psychodynamic Formulation, are widely used and translated. Ali Calkins‐Smith received her PhD in Clinical Psychology with a Major Area of Study in Clinical Health Psychology from the University of Kansas in 2018. She

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Notes on Contributors

c­ompleted her Pre‐doctoral Clinical Internship and Post‐doctoral Fellowship at Children’s Mercy Hospital in Kansas City, Missouri. Her research and clinical interests are both broadly in the area of pediatric psychology with specific interests in adherence and pediatric chronic pain.  Her dissertation was titled, “Adherence Behaviors in Youth Following the Completion of an Intensive Pain Rehabilitation Program.” Dr. Calkins‐Smith became licensed in 2019 and started her first position as the sole psychologist in a well‐established primary care pediatric office in Kansas. Chia‐Hsin Emily Cheng is Lecturer of Psychology and Health Science at California State University, Fullerton. She has served as co‐principal investigator of a CDC funded interdisciplinary obesity research project and as evaluation analyst on several health promotion programs in minority communities. She is on the editorial board of the Californian Journal of Health Promotion and is a doctoral candidate at the University of California, Los Angeles. Alan J. Christensen PhD is Professor and Collegiate Fellow in the Department of Psychology and Professor in the Department of Internal Medicine at the University of Iowa. He currently serves as Editor‐in‐Chief of the Journal of Behavioral Medicine and is a Past President of the Society of Behavioral Medicine. He has studied issues involving patient treatment adherence and self‐management in chronic illness for over three decades. Anne Cohen is a current Masters Student in the Nutrition and Exercise Physiology program at Teachers College, Columbia University and has a BA in Behavioral Biology from Johns Hopkins University. She previously worked as a Research Assistant at the Center for Behavioral Intervention Technologies at Northwestern University. Jason P. Connor is a clinical psychologist, Director of the Centre for Youth Substance Abuse Research, and Professor of Clinical and Health Psychology at the University of Queensland. Michael Copenhaver is a Professor of Health Promotion in the Department of Allied Health Sciences and a principal investigator at the Institute for Collaboration on Health, Intervention, and Policy (InCHIP) at the University of Connecticut, and a licensed clinical psychologist in Connecticut. He conducts primarily NIH/NIDA‐ funded research aimed at developing and adapting evidence‐based behavioral HIV prevention interventions for optimal use in real world clinical settings (drug treatment, prison) where high‐risk drug users may be more efficiently reached. Dr. Copenhaver has been at the University of Connecticut since 2002. Paul Crawshaw is Professor of Sociology and Dean of the School of Social Sciences, Humanities and Law at Teesside University, UK. A medical sociologist by training, he has published extensively on health improvement interventions, behavioural change, and sociologies of risk in a range of international journals, including Social Science and Medicine and Critical Social Policy. A former editor of Critical Public Health, he continues to contribute substantially to debates on health, wellbeing, and social policy, with particular interest in complex interventions.

Notes on Contributors

xvii

Adam Danquah is a Lecturer in Clinical Psychology at the University of Manchester. He has particular interests in attachment theory and psychoanalysis. Clinically he works in secondary care adult mental health for Pennine Care NHS Foundation Trust. As well as being a Clinical Psychologist, Adam is a Psychodynamic Psychotherapist. Chris Desmond is the Director of the Centre for Liberation Studies in Durban, South Africa. Seeta Durvasula is a Senior Lecturer in the Faculty of Medicine and Health, University of Sydney. She is also the Clinical Director of two specialized multidisciplinary health clinics for people with intellectual disability and complex health conditions. Seeta has over 30 years of clinical experience in health assessment and healthcare in people with intellectual disability. Her research areas are in mortality, falls, frailty, and health outcomes in people with intellectual disability. Andrew L. Ellner is an Associate Physician and Assistant Professor of Medicine, Division of Global Health Equity, Brigham and Women’s Hospital, and director of the Program in Global Primary Care and Social Change, Harvard Medical School, Boston, Massachusetts. Glyn Elwyn is a clinician, researcher, and innovator. He is a tenured professor at the Dartmouth Institute for Health Policy and Clinical Practice, USA, and at the Scientific Institute for Quality of Healthcare, Radboud University Nijmegen Medical Centre, the Netherlands. He leads an international interdisciplinary team examining the implementation of shared decision‐making into clinical settings. He investigates the design and impact of Option Grids™ patient decision aids, evidence‐based tools that empower people to choose the care that suits them best. He has developed the Observer OPTION and collaboRATE, measures of shared decision‐making. He is the lead editor of Shared Decision‐Making: Evidence‐Based Patient Choice (3rd edn., 2016). He has authored 369 peer‐reviewed publications. Bill (K.W.M.)  Fulford  is a Fellow of St. Catherine’s College and Member of the Philosophy Faculty, University of Oxford, Emeritus Professor of Philosophy and Mental Health, University of Warwick Medical School, and Director of the Collaborating Centre for Values‐based Practice, St. Catherine’s College, Oxford (valuesbasedpractice.org). His Essential Values‐based Practice (2012), co‐authored with Ed Peile, is the launch volume for a new series from Cambridge University Press on values‐based medicine. Robin E. Gearing PhD LCSW is an Associate Professor and Director of the Center for Mental Health Research and Innovations in Treatment Engagement and Service at the University of Houston. Dr. Gearing’s research focuses on improving the mental health outcomes of adolescents and young adults with serious mental illnesses, and their families. His research is driven by an interest in informing and improving engagement and adherence to empirically supported psychosocial and medication treatment, and developing evidence‐based interventions. This interest is the result of more than 20 years of clinical work with adolescents and young adults, of having firsthand professional knowledge of the needs and gaps in the field, and of seeing uneven efforts to

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manage the devastating functional, emotional, and fiscal costs of serious mental health conditions. His research nationally and internationally concentrates on treatment engagement and adherence in relation to mental health treatment, cultural adaptation, service delivery, and service utilization. Sunita Guha received her Doctorate in Clinical Psychology from the Trent Course (Universities of Nottingham and Lincoln, UK) in 2013. Since qualifying, she has specialized in working with individuals with complex developmental and communication difficulties, developing skills and expertise through working in a variety of settings, including forensic, inpatient, crisis teams and in the community. She is particularly interested in how people and systems cooperate in the delivery of services. She regularly teaches on the Leicester and Trent clinical psychology doctorates on subjects linked to intellectual and developmental disabilities, adapted working and systemic family practice. Peter M. Haddad is an Honorary Professor of Psychiatry at the University of Manchester, UK, and a Senior Consultant Psychiatrist at Hamad Medical Corporation, Qatar. He previously worked as an NHS Consultant Psychiatrist in Manchester for 20 years. His research focusses on psychosis and affective disorders. He has authored over 170 publications and has been a member of treatment guidelines groups for both the National Institute for Health and Care Excellence and the British Association for Psychopharmacology. Martin S. Hagger PhD is John Curtin Distinguished Professor at Curtin University, Perth, Australia, and Finland Distinguished Professor, University of Jyväskylä, Jyväskylä, Finland. His research focuses on the development of integrated theories to predict, understand, and change health‐related behavior in multiple contexts and populations. His most recent publication is (with D.K.C. Chan, C. Protogerou, and N.L.D. Chatzisarantis) “Using meta‐analytic path analysis to test theoretical predictions in health behavior: An illustration based on meta‐analyses of the theory of planned behavior,” Preventive Medicine, 89, 154–161. Judith A. Hall received her PhD from Harvard in Social Psychology and was on the faculty at the Johns Hopkins University before moving to Northeastern University, where she is University Distinguished Professor. Dr. Hall has been Editor‐in‐Chief of Patient Education and Counseling and the Journal of Nonverbal Behavior, and has published over 200 articles, chapters, and books on interpersonal interaction and non‐verbal communication, including in the physician–patient context. Rob Horne is Professor of Behavioural Medicine at University College London. His research focuses on the role of psychological and behavioral factors in explaining variation in response to treatment. His current interests center on the development of interventions to support engagement with essential treatments and on optimizing the non‐specific effects (placebo and nocebo components) of medicines. He is a Founding Fellow of the Royal Pharmaceutical Society and Fellow of the Faculty of Pharmaceutical Medicine. M. Bryant Howren PhD MPH is the Co‐Director of the VA Office of Rural Health Resource Center located at the Iowa City VA Medical Center and an Assistant

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Professor of Psychology at the University of Iowa. Dr. Howren is broadly interested in treatment adherence and illness self‐management, is an Associate Editor for Journal of Behavioral Medicine, and has published articles in Health Psychology, Annals of Behavioral Medicine, and Journal of Consulting and Clinical Psychology. Lyndsay D. Hughes is a Lecturer in Health Psychology at the Institute of Psychiatry, Psychology and Neuroscience, King’s College London. Lyndsay has been researching the psychosocial factors related to medication adherence in a range of conditions for the past 10 years. She has a particular interest in supporting people in taking their medication through theory‐driven interventions and in advocating the patient perspective to healthcare professionals to promote shared decision‐making and treatment engagement. Richard Huxtable is Professor of Medical Ethics and Law, and Director of the Centre for Ethics in Medicine, University of Bristol, UK. He has published numerous books and articles on healthcare ethics and law, particularly on end‐of‐life decision‐making, surgical ethics, and clinical ethics. Richard is an editor of BMC Medical Ethics and a trustee of the UK Clinical Ethics Network and the National Council for Palliative Care. Twitter: @DrRHuxtable. Lawrence Jones started his career working in the community with hard to place ex‐offenders. He initially trained as a forensic psychologist and worked in the prison service, primarily with life sentence prisoners and people who had a personality disorder diagnosis. He then went on to train as a clinical psychologist and work in Rampton Hospital where he is currently a Consultant Clinical and Forensic Psychologist and Head of Psychology. He is an Honorary Associate (Clinical) Professor at Nottingham University and teaches on the forensic doctorate there. He also teaches on the Leicester and Sheffield clinical psychology doctorates. He has published on motivational intervention assessment with people who have offended, working with people who have personality disorder diagnoses, case formulation, working with people who have offended sexually, and trauma‐informed milieu in forensic settings. Pramila Karki is currently completing her master’s degree in health promotion at the University of Connecticut. Her research interests include HIV/AIDS and sexually transmitted diseases, healthcare disparities, and program evaluation. Her current research involves assessing how people who use drugs (PWUD) value specific attributes of Pre‐Exposure Prophylaxis (PrEP) programs. She also works as a research assistant on a NIDA‐funded project, Secondary HIV Prevention and Adherence Among HIV‐infected Drug Users, under the direction of Dr. Michael Copenhaver. Karey S. Kenst MPH is the Senior Program Manager at the Disparities Solutions Center. She has over 12 years of professional experience in the areas of international humanitarian response, LGBT health, and sexual violence prevention and response. She is dedicated to working with institutions and communities to advance health equity and believes in collaborative, interdisciplinary approaches that reach beyond clinical settings to address the social determinants of health.

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Nikolaj Kunøe PhD is a Clinical Psychologist specializing in addiction treatment. He is Clinical Research Adviser at the Lovisenberg Deaconal Hospital, Division of Mental Health, and Postdoctoral Fellow at the Norwegian Centre for Addiction Research (SERAF), at the University of Oslo, Norway. His key research areas include alcohol and opioid addiction, pharmacotherapies for addictive disorders, prison health, and relapse prevention. Emily G. Lattie is a Research Assistant Professor in the Department of Preventive Medicine at Northwestern University and a faculty member within Center for Behavioral Intervention Technologies. Dr. Lattie received her PhD in clinical health psychology from the University of Miami. Her current research focuses on the use of technology‐enabled services to promote health and wellbeing. Sharon Lawn is Director of Flinders Human Behaviour and Health Research Unit, Department of Psychiatry, Flinders University, Australia. She worked in several healthcare services prior to her current role and has led many research projects in mental health, consumer and career perspectives, health‐system change, workforce development, and chronic condition management. Sharon is a national advocate in the mental health field, winning several awards for her work in supporting health‐system change. Peter Lewis is Senior Lecturer and Director Academic Workforce, in the School of Nursing and Midwifery at Western Sydney University. He worked as a registered nurse specializing in paediatrics for more than 15 years. Peter occupied a number of clinical roles before pursuing an academic career. He combines school governance responsibilities with research interests in the development of care models for people with intellectual and developmental disability and nursing history. Alex Lord is a Forensic Psychologist at Broadmoor Hospital. He is on the editorial board of the Journal of Forensic Practice and previously worked in HM Prison Service and was Visiting Lecturer at Surrey University. His PhD was on leadership and organizational culture, while his MSc researched attitudes to change, job satisfaction, and security in the public sector. He has published on mentally disordered sexual offenders, secure recovery, Good Lives Model, cognitive schemas, offense denial, and impacts on staff working with personality disorder. Andrea O. Madu BA is the Senior Research Assistant at the Disparities Solutions Center. She received her Bachelor of Arts in Psychology from Harvard University in 2013. She is passionate about reducing healthcare disparities for vulnerable populations and has over five years of experience in the fields of healthcare and community‐ participatory research. Previously, she interned at the Harvard Center for AIDS Research to develop a national survey on HIV/AIDS stigma and behaviors within the black community. Patricia Marino PhD is an Associate Professor of Psychology in Psychiatry at Weill Cornell Medicine of Cornell University. Her research interests include the identification of psychological and psychosocial barriers to the dissemination of and engagement in evidence‐based mental health interventions among older adults. Dr. Marino

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is a member of the research team at the Weill Cornell Institute of Geriatric Psychiatry and coordinates several research studies in the area of late‐life mood disorders. Donald E. Morisky is currently a Research Professor at the UCLA Fielding School of Public Health where he has taught and mentored for the past 36 years. His research addresses the social and behavioral determinants of infectious and chronic diseases management and the role of provider/patient communication and family‐member involvement in improving adherence to medical recommendations. He graduated from the Johns Hopkins School of Hygiene and Public Health with a Doctorate of Science in Health Education and Health Behavior in 1981. In 2006, he was awarded the prestigious Elizabeth Fries Prize for substantial contribution to advancing the field of health education/health promotion through research, program development, and program delivery. A Distinguished Fellow of the American Academy of Health Behavior, the Society of Public Health Education, and 2013 recipient of the Distinguished Career Award, APHA, PHE&HP Section, Dr. Morisky is a frequent consultant with global health organizations, including the WHO, UNFPA, UNAIDS, USAID, and UNICEF. David Morris is Founding Director of the Trans‐disciplinary Centre for Citizenship and Community at the University of Central Lancashire, leading a wide‐ranging research portfolio of national and international research programs based on Connected Communities, a five‐year collaboration with the RSA. He has a background in social care, mental health in local and central government and was director of the cross‐ government National Social Inclusion Program. Christiana O. Oshotse is an undergraduate student at Duke University. She has experience working in rural North Carolina communities to assess and improve the self‐management practices of adults living with chronic diseases. After completing her undergraduate program in Public Policy Studies, Ms. Oshotse plans to obtain a Masters of Public Health and will pursue a career in medicine as a physician and researcher. Cleo Protogerou PhD CPsychol AFBPsS is an Adjunct Lecturer in the Psychology Department at the University of Cape Town, South Africa, and Research Fellow in the School of Psychology and Speech Pathology, Curtin University, Australia. Her research focuses on sexual risk‐taking behaviors among young people across settings and especially in sub‐Saharan African, intervention evaluation, and theory development. Her recent publications include, with B.T. Johnson (2014), “Factors underlying the success of behavioral HIV‐prevention interventions for adolescents: A meta‐review,” AIDS and Behavior, 18, 1847–1863. Michael A. Rapoff received his PhD in Developmental and Child Psychology in 1980 from the University of Kansas. Dr. Rapoff is currently Professor Emeritus in the Department of Pediatrics at the University of Kansas Medical Center. He also has an adjunct appointment in the psychology department at the University of Kansas and teaches an online course he developed on chronic pain across the lifespan. Dr. Rapoff retired on 31 December 2017 after 37 years and 10 months of service in the Department of Pediatrics at KU Medical Center. He is a licensed psychologist in

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Kansas. His research, which was funded by NIH and the Arthritis Foundation, over the past 37 years has focused on adherence to pediatric medical regimens and chronic pediatric pain. Dr. Rapoff has 72 peer‐reviewed publications in journals, three books, including the second edition of a single‐authored book published in 2010 on medical adherence (Adherence to Pediatric Medical Regimens, 2nd ed.), and 29 book chapters. In 2003, Dr. Rapoff received the Distinguished Scholar Award from the Association of Rheumatology Health Professionals, a division of the American College of Rheumatology. Also, in 2003, Dr. Rapoff was elected as a Fellow in the Society of Pediatric Psychology. He served as President of the Society of Pediatric Psychology (Division 54 of the American Psychological Association) in 2013. He was board certified in Clinical Child and Adolescent Psychology by the American Board of Professional Psychology in 2015. Dr. Rapoff taught and advised clinical psychology students in pediatric and health psychology and taught residents and medical students. He also saw patients three days per week in his Behavioral Pediatrics Clinic. ​ Anne I. Roche BS is a clinical health psychology doctoral student in the Department of Psychology at the University of Iowa. She works under the mentorship of Dr. Alan Christensen and her broad research interests include the exploration of psychological constructs as potential targets for health and behavior change interventions, particularly in chronic disease populations. Mollie A. Ruben received her PhD from Northeastern University in Psychology and completed a two‐year postdoctoral fellowship with the US Department of Veterans Affairs in the Center for Healthcare Organization and Implementation Research at the VA Hospital in Jamaica Plain, MA. She is currently Assistant Professor of Psychology at University of Maine where she conducts research and publishes on topics related to patient–provider interactions, non‐verbal communication,  physical pain, and sexual and gender minority health. Isabelle Scholl is head of the research group for “Patient‐Centered Care: Evaluation and Implementation” within the Department of Medical Psychology at the University Medical Center Hamburg‐Eppendorf. She is a health services researcher, particularly focusing on measuring and implementing shared decision‐making and patient‐ centered care. Isabelle received her doctorate from the University of Hamburg, has a  degree in psychology from the University of Freiburg, and is a licensed and ­practicing psychotherapist. Twitter: @IsabelleScholl. Maureen Seguin is a Research Associate in the eHealth Unit at University College London and at the Centre for Health and Social Change at the London School of Hygiene and Tropical Medicine. She is a mixed‐methods researcher interested in comparative health systems and the potential of digital technology to improve the wellbeing of marginalized populations. Dolly Sen is a writer, artist, film‐maker, mental health consultant and trainer, with lived experience of psychosis and PTSD. Her previous chapter contributions to mental health books include: Looking for Rose Garden (2016); Encounters with Suicide (2014); From Communism to Schizophrenia and Beyond (2012); and Mental Health Recovery Heroes Past and Present (2011). She also has written creatively on mental health.

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Roman Shrestha is a Post‐doctoral Fellow in the Department of Allied Health Sciences at the University of Connecticut. His research interests lie broadly in the areas of HIV prevention, with a particular focus on combination approaches to HIV prevention (i.e. integration of biomedical and behavioral interventions), neurocognitive impairment, substance abuse, and use of mHealth technology. He has been involved in a number of NIDA‐ and CDC‐funded research projects that deal with HIV risk‐reduction among priority populations within community‐based, clinical, and criminal justice settings. Jo Anne Sirey PhD is Professor of Psychology in Psychiatry at Weill Cornell Medicine of Cornell University. Her research interests include the development, implementation, and dissemination of community‐delivered psychosocial interventions to improve engagement in mental health treatment among older adults. Dr. Sirey has been funded by the National Institute of Mental Health to improve engagement in mental health services among depressed community‐dwelling elders and test the effectiveness of the Treatment Initiation Program to improve treatment adherence. Roger J. Stancliffe PhD FAAIDD FIASSIDD is Professor of Intellectual Disability at the University of Sydney’s Centre for Disability Research and Policy. His applied research focuses on making a difference in the everyday lives of people with intellectual and developmental disability, ranging from research on transition into work to studies on ageing. Professor Stancliffe edited the Journal of Intellectual & Developmental Disability from 2003 to 2008. He is the recipient of the 2011 AAIDD Research Award. His most recent book is Transition to Retirement: A Guide to Inclusive Practice (2013). Stanley R. Steindl is a clinical psychologist in private practice at Psychology Consultants Pty Ltd., Brisbane, Australia, as well as an Adjunct Associate Professor at the School of Psychology, the University of Queensland, Brisbane, Australia. He is an experienced clinician and trainer in motivational interviewing, and is a member of the Motivational Interviewing Network of Trainers. Fiona Stevenson is a Reader in Medical Sociology and Co‐director of an eHealth Unit at University College London. She is an experienced qualitative researcher committed to delivering high quality research, education, and teaching. Her research focuses in particular on communication between healthcare professionals and patients and encompasses a range of clinical areas. Aswita Tan‐McGrory MBA MSPH is Deputy Director at the Disparities Solutions Center. She oversees the Disparities Leadership Program, an executive‐level leadership program on how to address disparities, as well as the broad portfolio of projects including collaborations on monitoring and reporting disparities and diversity initiatives. Her interests are in providing equitable care to underserved populations and she has over 20 years of professional experience in the areas of disparities and public health. Geoffrey P. Taylor MD is an Assistant Professor of Clinical Psychiatry at the University of Pennsylvania, where he is an attending psychiatrist on the

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consultation‐liaison psychiatry service. He has presented on the use of psychotherapy in the ­medical hospital at the national consultation‐liaison psychiatry conference. Ashwin Vasan is an Assistant Professor of Population and Family Health and Medicine at the Columbia Mailman School of Public Health and is the Executive Director of the Health Access Equity Unit at the NYC Department of Health and Mental Hygiene. Ann E. Webb is an attorney, a licensed clinical social worker, and a PhD student at the University of Houston, where her research focuses on the intersection of social work and the law, with a particular interest in multidisciplinary practice involving social workers and lawyers, and immigration issues affecting children and families. She has served as faculty on collaborative projects involving social work and law students assisting detained women and children seeking asylum. Her scholarly agenda is informed by her experience as a lawyer and social work clinician, and by her role as an advocate for underserved populations. John A. Weinman is Professor of Psychology as applied to Medicines at the Institute of Pharmaceutical Sciences and the Institute of Psychiatry, Psychology, and Neuroscience in King’s College London. The main focus of his research has been on the ways in which patients’ beliefs about their illness and treatment affect their self‐ regulation and self‐management. He is particularly interested in understanding the reasons underlying non‐adherence to treatment and in developing effective interventions for improving medicines use. Nathan J. Wilson is Associate Professor in the School of Nursing and Midwifery at the Western Sydney University. He worked as a nurse specialist intellectual disability nurse for 20 years prior to embarking on an academic career. Nathan’s clinical expertise focused on people with intellectual disability who also had chronic and complex health problems. Nathan’s research interests are in applied research that enhances the health, wellbeing, and social participation of people with long‐term disabilities. Maggie Winchcombe OBE FRCOT is a Director at Years Ahead. Maggie qualified as an occupational therapist in 1973 and has worked as an independent living adviser alongside disabled people since 1983. After 20 years of experience at local and national levels she established a consultancy role. Her published work includes research studies, good practice guides, and papers. Leah L. Zullig is a Health Services Researcher, Assistant Professor in the Duke Department of Medicine, and Research Investigator at the Center for Health Services Research in Primary Care at the Durham Veterans Affairs Healthcare System. Her research is supported by a VA HSR&D Career Development Award, focused on improving chronic disease management and treatment adherence among cancer survivors. She has authored over 70 peer‐reviewed scientific publications.

Acknowledgments

This book began life in 2010, in the shape of a proposal for a volume with more ­limited scope, and the editorial committee for that book, including Simon Draycott and David Reiss, were instrumental in the creation of the current handbook. The contribution of Amrit Sachar was invaluable. Alex Lord and Jean Ledger have remained consistent friends of the project, from conception until completion, with contributions including valued guidance and proofreading drafts of the introduction and afterword. Without the encouragement of Mary McMurran and Darren Reed at Wiley this book may not have developed into its current form. Our editors at Wiley, and Monica Rogers in particular, have maintained their encouragement, faith, and patience in this project over a prolonged period and for this we are immensely grateful. We must recognize the support of our librarians, who are always at risk of remaining among the unsung heroes of healthcare. These have included Pauline Bishop, Amy Dunn, and Helen Ewell, who have gone above the call of duty by assisting in the numerous literature searches which have informed our approach, as well as providing some of the volumes we have consulted. The lively correspondence we have enjoyed with many of the chapter authors has remained among the most rewarding aspects of our immersion in the topic; we are pleased that this continues past the completion of the chapters and look forward to future collaborations. Not only have we been welcomed into a greater understanding of their work, but have been inspired by the continued commitment made by the authors through major life events and unexpected challenges in the world of clinical practice. We have followed our authors through their own experiences of ill‐health and medical treatment including emergency surgery and chemotherapy, as well as for conditions as varied as pneumonia, fracture and, happily, a new birth. We thank our friends, who have provided sustenance through their good humor and warmth as we have worked toward completion, as well as those who have offered valued comments and opinions. We have greatly enjoyed working with Mathilde Le Coutour, who has brought a creative flair by means of her art work for the volume. Finally, we must acknowledge the love and support of our families and partners, whose faith and encouragement we have been able to depend on during the years we have been wedded to this project.

Introduction Key Points • The literature refers to individuals who have sought help to improve their health, but struggle to initiate and maintain commitment to health behavior change. • The literature on the topic of adherence to treatment with medication demonstrates low rates of adherence. • In order to understand the behavior of patients who seek to engage in healthcare treatment, it may be necessary to look beyond the rational assumptions implicit in the “medical model.” • The global burden of disease is increasingly shifting toward chronic health conditions and co‐morbidities, for which management commonly requires changes in health behavior such as lifestyle modification. • The concept of patient engagement in healthcare treatment reflects a broader definition of health behavior and healthcare treatment than adherence to medications alone, supporting more holistic approaches to healthcare delivery. • Interventions to enhance patient engagement in treatment may include innovations in the manner in which healthcare services are delivered and types of treatment offered, as well as measures to address structural barriers preventing patients accessing those treatments. Since the dawn of the practice of medicine, healthcare providers have struggled to engage patients in treatment. In fact, Hippocrates recognized that patients might appear to deceive their physicians when asked about their medication‐taking, as described in The Decorum: Keep watch also on the faults of the patients, which often makes them lie about the ­taking of things prescribed. (Jones 1923)

Reading the above comment through the lens of the major themes of this volume suggests that here Hippocrates is failing to appreciate his patient’s role as an autonomous The Wiley Handbook of Healthcare Treatment Engagement: Theory, Research, and Clinical Practice, First Edition. Edited by Andrew Hadler, Stephen Sutton, and Lars Osterberg. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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Introduction

actor in the process of treatment and, instead of seeking to understand their behavior, maintains an expectation that the patient will act according to the advice offered by the physician.

Introduction: What Is This Book About? This book is being published at an exciting time. Life expectancy is rising, the causes of mortality and morbidity are increasingly understood, and a range of highly effective treatments are available to an increasing proportion of the global population. However, health systems across the globe face rising costs and ill health predominantly due to chronic health conditions which often include in their etiology a significant contribution from lifestyle factors (OECD 2017). However, simply because a treatment which has the potential to save a person’s life is readily available, it cannot be assumed that such treatment will be implemented effectively. As described by Oshotse et  al. in Chapter  1 of this volume, approximately half of patients with chronic diseases fail to adhere to prescribed medications and thus do not gain benefit from treatment. Contrary to the expectations of the majority of practitioners, non‐adherence to prescribed treatment may even be regarded as the norm rather than the exception. It has been postulated that, because the results could be applied so broadly, effective ways to help people follow medical treatments could have far larger effects on health than any treatment itself (Haynes et al. 2002; Sabaté 2003). This volume seeks to inform the reader of the extent, causes, and impact of suboptimal engagement in healthcare treatment, to explore issues such as the legal and ethical implications of practice in this field, and to describe a range of interventions applicable to the care of individual patients as well as the configuration of healthcare services and the health of populations, which may promote patient engagement in healthcare treatment. A holistic stance is adopted throughout regarding wellbeing and healthcare treatment, respecting as healthcare treatments a variety of approaches that go beyond pharmacological and surgical interventions. Other approaches increasingly constitute contemporary healthcare treatment, including lifestyle modification and social prescribing, the practice of referral to non‐clinical services in order to improve health (Pescheny et al. 2018). The literature on the topic of medication adherence finds that no single approach is likely to prove successful in improving treatment outcomes by improving treatment adherence (National Institute for Health and Care Excellence [NICE] 2009; Nieuwlaat et  al. 2014) and that interventions tailored to the needs of individual patients will be required (Sabaté 2003). To address these needs, an interdisciplinary approach is adopted throughout the volume, drawing together theories from a range of clinical and academic specialties, all of which stand to enhance our understanding of the factors governing the motivations and behavior of patients, clinicians, and organizations. Eloquent explanations are offered of behaviors which run counter to expectations underlying the “medical model” and evidence‐based practice, such as that users of healthcare services will follow the rational expectations of healthcare providers. This is an evolving and exciting field. The concept of patient engagement in treatment fits with and complements contemporary developments and approaches which seek to increase patient choice and

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autonomy, such as patient‐centered care and shared decision‐making. It supports a more refined understanding of the specific needs of individual patients in their unique social context and acknowledges the responsibility of professionals to consider their own personal contribution to the clinical interaction. Patient engagement in healthcare treatment represents an advance in understanding, beyond more prescriptive notions such as treatment compliance, adherence, concordance, and treatment readiness; this is a broader and more inclusive concept, reflecting the complexity of treatment for many conditions as well as the characteristics of the patient, the treatment plan, and the circumstances in which care is delivered. Patient engagement in treatment is therefore the frame of reference throughout this volume, with the exception of references to sources which originally used alternative terms such as those above. It is intended that the current volume will serve to support practitioners and service planners who seek to improve the outcomes of existing treatments and models of service delivery across a range of healthcare settings, as well as increasing patient autonomy and satisfaction in treatment. In a time of budgetary constraints, the approaches presented will appeal to those who seek to improve the efficiency of health services. This chapter introduces the topic of patient engagement in healthcare treatment, setting out to signpost the reader to later chapters and pose the core issues which underlie this volume.

To which patients does this book refer? The person who may be imagined as the typical subject of much of this volume may have booked an appointment and attended a consultation with a healthcare practitioner, received advice which would support them in improving their health, and may have received a prescription for medication. In this volume the reasons will be explored as to why such a person might fail to improve their health, not because the proposed treatment lacked efficacy, but because the person’s behaviors continued unchanged, as if the consultation had never occurred. In addition, a variety of scenarios are explored, whereby structural barriers exist and prevent people from accessing and engaging in treatment. Such scenarios are very common indeed and may take many forms, determined by the vast range of health behaviors and the infinite variation in human characteristics, lifestyles, and real‐life healthcare situations. Specific chapters refer to patient groups and populations for whom specific considerations should be borne in mind, such as children, people from diverse backgrounds, or those subject to social exclusion.

To which health conditions and treatments does this book apply? Regarding the adoption and implementation of treatment recommendations as a form of behavior change, this volume applies as much to changes in health‐related behaviors such as dietary change or participation in psychological therapy as to medication taking. The inclusive definition of patient engagement in healthcare treatment described below is intended to encompass all aspects of a treatment plan, considering the variety of components which this may include. For example, as well as focusing on the medical treatment of hypertension, the concept of patient engagement in treatment may also apply to an overall treatment plan addressing an individual’s cardiovascular

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risk factors. Such an approach encompasses the increasing recognition, described in Chapter 31, that health behaviors are often manifested in “clusters” within populations and that there are strong associations between the occurrence of health‐related behaviors within individuals. Rather than focusing on individual treatments, health conditions, or treatment settings, the authors have generally presented approaches with widespread relevance which may be tailored to the needs of the individual patient or practitioner; this approach to the structure of the volume is described in more detail below. The approaches described in this volume apply as much to the treatment of acute as to chronic conditions. In the context of the global epidemiological transition from infectious to non‐communicable disease (see Chapters including 1, 7, 25, 31), medical conditions occur increasingly in the context of complex co‐morbid conditions, with associated increases in the complexity of the treatment plan, reducing the likelihood of effective adherence to and engagement in that plan. Bearing in mind the complex patterns of co‐morbidity which may commonly arise, the editors have sought to create a volume equally relevant to physical and mental health conditions and treatments, addressing factors which may detract from engagement in treatment such as co‐morbid substance abuse. Treatment may include advice which may have been understood by the person, yet they subsequently find it beyond their ability to achieve meaningful change in their behavior. In spite of their limited success in achieving change, they may nevertheless continue to attend further consultations, potentially hearing the same advice repeated by the same professional. Unseen costs may thus be incurred by both service providers and health service users. Hidden costs, inefficiencies, and sources of dissatisfaction include repeated attendance for consultation regarding partially treated illness as well as inpatient admissions for acute exacerbations of chronic conditions arising due to non‐adherence to medication or a lack of success in achieving lifestyle modification (Osterberg and Blaschke 2005). Findings in this field include the global stockpile of medications stored at home after medication prescriptions have been dispensed, collected and, although not taken as intended, continue to accumulate in growing collections (Trueman et al. 2010). Innovation in health treatments and technologies are arising at a fast pace through the prodigious efforts of a vast community of researchers, practitioners, and planners. However, such developments may prove to be limited in their potential depending upon the behavior of the recipients of treatment. Fortunately, parallel developments in approaches to conceptualize and address the realm of health behavior, communication, and means of supporting behavior change are also proceeding at a rapid pace across a range of disciplines.

Who is the target audience for this book? As mentioned in the preface, the editors have considered the audience of this volume to include any healthcare professional, student, or trainee, from any discipline or field of practice in healthcare, as well as service planners, policymakers, and third sector workers. The reader may be any person who can expect to speak to patients or their caregivers regarding health, wellbeing, healthcare treatment, or health behavior, as well as any person involved in delivering, commissioning, planning, or setting direction in health services or systems.

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Just as a sizeable proportion of research in healthcare is devoted to the development of new treatments and technologies, the reader may have invested greatly in technical aspects of their training and may have developed a wealth of clinical experience. However, it is possible that their training may not have anticipated the reality of human behavior in relation to health (see Chapter 15) and may have instead rested upon cause‐and‐effect assumptions implicit in the tradition of biomedical science, for example that treatments and health advice offered will be accepted, embraced, and enacted by patients. Whilst the reader will recognize elements such as verbal and non‐verbal communication as crucial components of healthcare, they may have had little opportunity to reflect on structured approaches to improve their interactions with patients. Equally, the reader may be familiar with terms such as patient‐centered care, shared decision‐ making and motivational interviewing, without having had the opportunity to consider how to integrate such approaches into their clinical practice, potentially transforming routine clinical interactions through attention to the therapeutic relationship as a potent agent of change. The reader may well work in a clinical team and practice in a complex system of healthcare service delivery. Challenges in this field may surpass the ability of individual practitioners to address, and the current volume includes resources which may be shared with colleagues in order to develop services to help promote patients’ engagement in treatment.

The Concept of Patient Engagement in Healthcare Treatment Throughout this volume, the topic of patient behavior in relation to healthcare treatment is typically regarded as a complex process, which may consist of various inter‐ related elements. Furthermore, it is accepted that the etiology and treatment of many health conditions may be understood differently by patients and the practitioners who recommend treatment (see Chapters 10, 11, 28): such gaps in understanding may go a considerable way toward explaining behaviors which constitute engagement in healthcare treatment, as may factors attributable to the treatment and the treatment setting which present barriers to engagement in treatment. In order to provide a foundation from which health behavior may more meaningfully be addressed in this context, the editors considered it necessary to go beyond “treatment adherence” as the central frame of reference for this volume. As described by Oshotse et al. in the first chapter in this volume, the term treatment adherence is the result of an evolution of terms which implies a less paternalistic approach than was implied by terms previously used, such as compliance. Whilst various definitions of treatment adherence exist, the most widely recognized appears to be that of Haynes: the extent to which patients follow the instructions they are given for prescribed ­treatments. (Haynes et al. 2008)

Here, we prefer the term patient engagement in healthcare treatment, as we find the term to more readily encompass an open‐minded approach, encouraging reflection on the characteristics of the person accessing treatment and their perspective on their condition, as well as external factors which may impact upon participation in treatment.

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Box I.1  The Factors Identified by the Editors, to Inform the Definition of Patient Engagement in Healthcare Treatment Adopted in This Volume • The definition should support an open‐minded approach when conceptualizing patient behavior, assuming the recipient of care as an independent actor. • In contrast with the existing definitions of treatment adherence, greater consideration is warranted regarding the processes at play for each individual patient, influencing their interaction with treatment. • The definition should support practice in the management of chronic health conditions, when health behaviors other than medication‐taking may be highly significant, as may behaviors constituting self‐management of the condition. • The definition should recognize health behavior as dynamic and support consideration of factors that are liable to change, as well as encouraging observation of change over time. • The definition should both respect the influence of factors outside of the clinical interaction such as the social circumstances of the person seeking treatment and acknowledge that changes may be required in the system delivering care if patient engagement in treatment is to be optimized.

Whilst we found that the term patient engagement is widely used in fields such as psychological therapy (Tetley et al. 2011), mental health (Fortney and Owen 2014; Priebe et al. 2005), and substance abuse treatment (Carroll et al. 2006), and has been applied to other scenarios such as self‐management of chronic health conditions (Reidy et al. 2016), and in service design (Coulter 2011), we were not able to identify a definition applicable to routine clinical practice and therefore formulated a definition for the purpose of this volume. The broader definition adopted below does not preclude definitions of the term “patient engagement” as applied to fields such as those above (Center for Advancing Health 2010; Coulter 2011), but rather, such concepts may be subsumed within the more inclusive definition. Our definition of patient engagement in healthcare treatment, is therefore as follows: Treatment engagement is a dynamic concept requiring consideration of the patient’s preferences, attitudes, decisions, and behavior regarding their treatment, alongside the characteristics of the treatment, the treatment setting, and the relationship between the patient and the professionals delivering their care.

The definition spans the broad range of topics included in this volume, encompassing treatment scenarios when the attitudes of the person receiving care may be a prominent factor influencing the treatment outcome, as well as situations when healthcare is delivered in settings where material resources are scarce, services may be hard to access, and any behavioral element may be the least significant determinant of participation in treatment (see Chapters 18, 24, 25, 31). It is anticipated that the concept of patient engagement in healthcare treatment adopted in this volume will support consideration of the characteristics of the person seeking treatment, alongside theories which seek to explain health behavior, and approaches to promote behavior change.

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How Have We Approached This Topic? The structure of the book This volume is divided into five parts, outlined below. As well as the core topics covered, each chapter includes “Key Points” as a guide to the material, as well as clinical vignettes where appropriate. Through the overall structure of the volume, it will be clear to the reader whether the material is particularly relevant to the clinical style of the practitioner or at a specific stage in treatment such as assessment, formulation, treatment planning, monitoring, or long‐term maintenance. The authors of each chapter have been chosen on the basis of their expertise, as can be seen in the author biographies; the authors and editors have collaborated to offer a commentary where appropriate, creating links between the chapters to improve the experience of the reader. A core principle of the volume, supported by the literature on this topic, is that a one‐size‐fits‐all approach to promoting patient engagement is unlikely to be effective (Nieuwlaat et al. 2014), and therefore the volume presents a range of approaches which may be applied to different settings, allowing the healthcare provider to tailor their approach and adapt to the needs of the patient before them. For example, the reader may be a specialist nurse in a diabetes clinic, who is struggling to support a patient whose treatment for diabetes is complicated by erratic behavior and substance misuse, and may therefore prioritize chapters on the topics of attachment theory, psychodynamic factors, case formulation, substance abuse, and motivational interviewing. Toward the goal of promoting a critical and open‐minded approach to the field of patient engagement in healthcare treatment, the reader may explore the potential impact of their values as a practitioner (see Chapter  3) or patients’ perceptions of attributes such as the gender of their healthcare provider (see Chapter 15). In addition, the reader will benefit from being aware of structural barriers to accessing healthcare by people from ethnic minority backgrounds (see Chapter  18) or who are otherwise subject to social exclusion (see Chapters 24, 31). The volume includes

Box I.2  The Five‐Part Structure of This Volume • Section 1: Background – in which topics forming the foundation of the subject of patient engagement in treatment are described. • Section 2: Understanding patient engagement in healthcare treatment – presenting theoretical models explaining patient engagement in treatment. • Section 3: Practical approaches to enhance patient engagement in healthcare treatment – describing therapeutic approaches to enhance patient engagement in treatment. • Section  4: Treatment engagement in specific client groups  –  clarifying the needs of specific patient populations. • Section 5: Designing and delivering services to optimize patient engagement – considers organizational change to promote patient engagement in treatment as well as “larger scale” approaches such as developing healthcare services to encourage patients to engage in treatment.

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some potentially surprising exceptions, for example of healthcare service users who prefer a paternalistic approach by practitioners above opportunities to engage in shared decision‐making (see Chapter 15).

What Have We Have Sought to Achieve? We hope that the reader, sufficiently curious to sample this volume, when faced with a patient who is indicating suboptimal engagement in treatment, is not likely to blame the patient for their behavior and accept the poor outcomes which may subsequently arise. The current volume not only seeks to offer factual information but to encourage the reader to adopt a critical and reflective stance, seeing this field of practice in a new light with a changed understanding of the behavior of patients and healthcare professionals. We regard this volume as one development in the ongoing evolution in the manner in which patient behavior in relation to health conditions is understood and care is delivered. Having reviewed earlier books describing the core topics of this volume, it is heartening to note the progress which has been made in the 40 years since the first books were published in this field (Haynes et al. 1979).

Box I.3  Developments in This Field in the Past Forty Years • Robust meta‐analyses and treatment guidelines on the topic of treatment adherence (see Chapter 1) (NICE 2009). • Development of validated methodologies to monitor treatment adherence including psychometrics to explore patients’ understanding of health conditions and treatment (see Chapters 5, 11). • An increasing understanding of the social determinants of health (see Chapters 1, 18, 24, 31) (Marmot et al. 2012). • Health policy enshrining the role of patients as autonomous actors (see Chapter 31) (Department of Health 2010). • Broader concepts of healthcare treatment, for example in relation to social prescribing (see Chapter 24). • Increased accessibility of health‐related information via internet platforms (see Chapter 30). • Service user movements, activism, and advocacy, including using social networking and internet based fora (see Chapters 12, 26, 30) (Wallcraft 2010). • Advocacy for increased consultation with health service users in healthcare service design (see Chapters 29, 31) (Center for Advancing Health 2010; Coulter 2011; Ocloo and Matthews 2016). • Widespread acceptance of measures of wellbeing going beyond the definition of health as “an absence of illness” (see Chapter 14) (Marks and Shah 2005). • Greater consideration of wider measures of success of treatment than technical outcome, including Patient‐Reported Outcome measures and measures of patient perception, satisfaction, and experience (see Chapters 2, 29).

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• Paradigms of care such as patient‐centered care (see Chapter 15). • Innovations in approaches to communication including shared decision ‐ making and motivational interviewing (see Chapters 15, 28, 13). • Increasing adoption of service models to promote patient self‐management of chronic conditions (see Chapter 29). • Greater understanding of encounters between healthcare providers and service users within the social sciences (see Chapters 30, 31) (Mechanic 1995). • Widespread availability of smartphone technology and wearable monitoring devices to support health behavior change (see Chapters 12, 29). • Increasing understanding of decision‐making, for example in fields such as decision theory and behavioral economics, including the role of emotions in decision‐making (see Chapters 11, 29).

We can observe that a traditional understanding persists of interactions between those receiving healthcare and those who deliver it, based on assumptions that the person in need of care will follow advice when it is offered by professionals. As described in chapters including 10 and 11, such assumptions have tended, for example, to overlook the beliefs and representations used by patients to guide decisions regarding their health as well as the significant role of emotional processes in decision‐making and behavior. Whereas at first glance, when considering the impact of suboptimal treatment adherence, the behavior of patients may seem paradoxical, it is highly unlikely that patients are actively seeking to remain unhealthy. In the implicitly rationalist tradition of evidence‐based medicine, it is argued that current models of service delivery are founded upon paradigms which relate to patients as “rational” actors, potentially failing to take account the social and psychological factors which guide their behavior. At the level of the individual consultation, significant questions may go unanswered, because they have not been asked and, instead, assumptions have been unknowingly made and taken for granted. Otherwise, complex behaviors may be accounted for imperfectly by means of superficial explanations. It therefore appears safe to assume that this realm is often not adequately understood, and the current volume sets out to offer the reader a robust understanding of such seemingly counter‐intuitive scenarios. Relevant observations include that, as described in chapters including 7 and 13 of this volume, people generally do not take readily to initiating and maintaining changes in behavior and the processes underlying change in health behavior may not differ widely from those in other behavioral domains (Thaler and Sunstein 2008). Returning to the topic of healthcare, if the person who has received advice regarding treatment does not believe that it will benefit them (see Chapter 10), is unable to understand or remember the advice offered due to cognitive impairment (see Chapter 6), or is simply prioritizing other commitments or realms of life above their health needs (see Chapter 25), then it is less likely that they will engage in treatment. In this volume, the reader will find material that may be well recognized by practitioners and academics in certain fields but not yet widely put into practice or, at least, not yet widely incorporated into the assumptions underlying the delivery of

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healthcare. Within this realm lies the wealth of understanding derived from the disciplines such as health psychology. The current volume does not set out to be a textbook of health psychology and respects the range of excellent texts available on this topic. However, it is recognized that the field of health psychology offers some compelling explanations and theories of behavior which could be better integrated into routine care delivered by a wide range of healthcare professionals, who stand to benefit from understanding and applying a touch of health psychology to their practice. In spite of the relevance of the discipline of health psychology to clinical practice, it is recognized that this is one of many topics which may not until recently have been included in the traditional training curricula of many professional disciplines (Ayers and De Visser 2018). Respecting the immense variability in the needs and characteristics of patients, we have presented a variety of theoretical models to support the understanding of health behavior, providing a menu of reading that may be chosen by the reader to respond to the needs of the patient or population before them. Resting on the understanding of health behavior presented in the earlier chapters of the book, a number of practical clinical approaches are described to support communication on healthcare topics and promote patients’ motivation toward achieving the changes in health behavior which they seek. Building further on the foundation established in earlier chapters, strategies for healthcare delivery are described in which the recipient of care is respected as an independent actor, such as shared and supported decision‐making and patient‐centered care (see Chapters 15, 28, 29). Recognizing that the best efforts of individual practitioners alone may not be sufficient, an overall theme of the volume is that change may be required at different levels in a health system or organization delivering care in order to increase patient engagement in treatment (see Chapters 29, 31).

The Obstacles We Have Sought to Overcome in This Volume Criticisms have been acknowledged throughout this volume of healthcare systems in which the perspective of users of services may be under‐appreciated. When coupled with a perceived imbalance of power or influence between service users and providers, such dynamics may be criticized as paternalistic (Coulter 2002). Nevertheless, it is unlikely that the majority of health professionals set out to adopt a paternalistic approach when delivering care and, as such, we are confident that the material presented in this volume will be embraced, rather than arouse suspicion or the sense of authority being undermined. In general, the so‐called “traditional interaction” would be one in which a benevolent practitioner, holding the knowledge relating to the health condition, its treatment, and the system in which care is delivered, offers advice to an individual with a health condition who seeks treatment (see Chapters 4, 15) (Foucault 1973). Whilst this may not, so far, seem immediately controversial, problems may arise when promoting behavior change, when the practitioner may not have received any specific training on this topic and may not fully appreciate that the recipient of care is an independent actor. For example, the practitioner may remain unaware of the strongly held beliefs which continue to motivate their patient’s behavior and of the potent negative emotions which may be aroused by their ongoing, albeit well‐meaning,

Introduction

11

advice (see Chapters 14, 15). With the aim of minimizing such scenarios, the value of the material in this volume may be at times as much about unlearning “old habits” as about learning new skills.

Operational considerations before implementing this material We recognize the challenges which may be faced by some readers in translating some of the material in this volume into practice. We have sought to present descriptions of a variety of theories and clinical methods in their original context, enabling the reader to consult with colleagues and use their local structures for clinical governance and supervision, in order to conclude which approaches may be applied to support clinical practice. The reader should bear in mind the potential limitation that theories and approaches which may appear to have “face value” may not prove successful when applied in settings other than those in which there exists a proven evidence base. Considering the diverse range of material described within this volume, an exploration of the evidence base applicable to such a broad range of topics is beyond the scope of this chapter and the reader is rather directed toward the original resources. With this in mind we advise a thoughtful and considered approach, using the advice of the relevant professional community in responding to the infinite variety of scenarios arising in routine clinical care.

A Note of Caution: Is All Treatment Worth Engaging In? It is hoped that the reader of this volume will be left more thoughtful as to the effects of advice and opinions offered to promote health and wellbeing, no matter how well meaning they may be. As described in Chapters 3 and 4 of this volume, patients must be respected as retaining the right to refuse treatment in all but exceptional situations. It must be emphasized that the volume is presented on the premise that, when referring to the treatment in which the reader may seek to engage patients, best practice guidelines are followed and every effort is taken to ensure that the most effective treatment is offered. Just as this volume refers to the topic of patient adherence to treatment, it is widely recognized that practitioners may be poorly adherent to treatment guidelines (see Chapter 29) (Cochrane et al. 2007; Reach 2015). This volume includes reference to healthcare delivery in an information age, where users of healthcare services will commonly access online resources to research their condition and treatment options and therefore will often be aware of best‐practice guidelines. In relation to practice where logistical, infrastructure, or resource constraints may impact on the quality of care available, as addressed in Chapter 25, there remains an absolute understanding that the approaches described within the volume will only be applied to engage patients in treatment which is effective and in their interests.

Conclusion It is clear that changes in health behavior are not easy to achieve. Nevertheless, in spite of the phenomenal growth in effective means of prevention, diagnosis, and treatment of illness, such methods will require patients to attend for appointments, follow

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Introduction

advice, or take prescribed treatments in order for them to gain any benefits. Founded upon the inclusive concept of patient engagement in healthcare treatment, this volume adopts an interdisciplinary stance to describe a variety of theories, strategies, and approaches to communication and service delivery to inform the practice and training of healthcare practitioners, enabling them to deliver healthcare services in which patients are more likely to engage. It is hoped that the approaches introduced here and described in the following chapters will yield additional value in delivering treatment regimens that patients agree to, believe in, and will be maintained over time. This chapter has introduced the reader to the core topics included in the current volume. Engaging patients in healthcare treatment can be a formidable challenge and at times the pace of change may be slow, particularly in the treatment of chronic conditions. Just as practitioners may require an awareness of the emotional processes at play for their patients, an awareness of one’s own values and emotional responses may prove to be of central importance. In practice, such problems may be too great for one person to successfully address alone. The current volume seeks to leave the reader feeling well placed to collaborate with patients and their caregivers, as well as colleagues in their healthcare organization, in order to work fluently toward promoting patient engagement, maximizing the benefits to be achieved from the most appropriate treatment. A note regarding terminology: It is recognized that the term “patient” is considered controversial by many, with connotations of passivity and an implied imbalance of authority with providers of healthcare. Alternative terms such as “service user” and “consumer” as well as more descriptive terms were considered for use in this chapter and the volume as a whole. As well as the linguistic limitations of such terms potentially appearing ambiguous in meaning and becoming cumbersome, the term “patient” has been used as it is anticipated that, in the context of the overall themes of this volume, it is clear that the recipient of care is respected as an autonomous actor whose opinions and preferences will be valued.

References Ayers, S. and De Visser, R. (2018). Psychology for Medicine and Healthcare, 2e. London: Sage. Carroll, K.M., Ball, S.A., Nich, C. et al. (2006). Motivational interviewing to improve treatment engagement and outcome in individuals seeking treatment for substance abuse: a multisite effectiveness study. Drug and Alcohol Dependence 81 (3): 301–312. https://doi.org/ 10.1016/J.DRUGALCDEP.2005.08.002. Center for Advancing Health. (2010). A new definition of patient engagement: what is engagement and why is it important ? Center for Advancing Health. doi:https://doi.org/10.1016/ j.pec.2010.02.002 Cochrane, L.J., Olson, C.A., Murray, S. et  al. (2007). Gaps between knowing and doing: understanding and assessing the barriers to optimal health care. Journal of Continuing Education in the Health Professions 27 (2): 94–102. https://doi.org/10.1002/chp.106. Coulter, A. (2002). The Autonomous Patient: Ending Paternalism in Medical Care, 1e. London: The Nuffield Trust. Coulter, A. (2011). Engaging Patients in Healthcare Treatment, 1e. Maidenhead: Open University Press.

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Department of Health. (2010). Equity and excellence: Liberating the NHS. Retrieved from https://assets.publishing.service.gov.uk/government/uploads/system/uploads/ attachment_data/file/213823/dh_117794.pdf Fortney, J.C. and Owen, R.R. (2014). Increasing treatment engagement for persons with serious mental illness using personal health records. The American Journal of Psychiatry 171 (3): 259–261. https://doi.org/10.1176/appi.ajp.2013.13121701. Foucault, M. (1973). The Birth of the Clinic: An Archaeology of Medical Perception, 1e. London: Tavistock. Haynes, R., McDonald, H., Garg, A., and Montague, P. (2002). Interventions for helping patients to follow prescriptions for medications. Cochrane Database of Systematic Reviews 2 https://doi.org/10.1002/14651858.CD000011. Haynes, R.B., Taylor, D.W., and Sackett, D.L. (1979). Compliance in Health Care, 1e. Baltimore: John Hopkins University Press. Haynes, R., Yao, X., Degani, A. et al. (2008). Interventions for enhancing medication adherence. Cochrane Database of Systematic Reviews https://doi.org/10.1002/14651858. CD000011.pub2. Jones, S. (1923). Hippocrates: English Translation. Cambridge, MA: Harvard University Press. Marks, N. and Shah, H. (2005). A well‐being manifesto for a flourishing society. In: The Science of Well‐Being, 1e (eds. F.A. Huppert, B. Nick and K. Barry), 503–532. Oxford: Oxford University Press https://doi.org/10.1093/acprof:oso/9780198567523.001.0001. Marmot, M., Allen, J., Bell, R. et al. (2012). WHO European review of social determinants of health and the health divide. The Lancet https://doi.org/10.1016/S0140‐ 6736(12)61228‐8. Mechanic, D. (1995). Sociological dimensions of illness behaviour. Social Science & Medicine 41 (9): 1207–1216. NICE. (2009). Medicines adherence: involving patients in decisions about prescribed medicines and supporting adherence. Retrieved from https://www.nice.org.uk/Guidance/ CG76 Nieuwlaat, R., Wilczynski, N., Navarro, T. et  al. (2014). Cochrane database of systematic reviews interventions for enhancing medication adherence (review). Cochrane Database of Systematic Reviews 11 https://doi.org/10.1002/14651858.CD000011.pub4. Ocloo, J. and Matthews, R. (2016). From tokenism to empowerment: progressing patient and public involvement in healthcare improvement. BMJ Quality & Safety 25 (8): 626–632. https://doi.org/10.1136/bmjqs‐2015‐004839. OECD Indicators. (n.d.). Health at a glance 2017. doi:https://doi.org/10.1787/health_ glance‐2017‐en Osterberg, L. and Blaschke, T. (2005). Adherence to medication. New England Journal of Medicine 353 (5): 487–497. https://doi.org/10.1056/NEJMra050100. Pescheny, J., Randhawa, G., and Pappas, Y. (2018). Patient uptake and adherence to social prescribing: a qualitative study. BJGP Open https://doi.org/10.3399/bjgpopen 18X101598. Priebe, S., Watts, J., Chase, M., and Matanov, A. (2005). Processes of disengagement and engagement in assertive outreach patients: qualitative study. The British Journal of Psychiatry: The Journal of Mental Science 187: 438–443. https://doi.org/10.1192/ bjp.187.5.438. Reach, G. (2015). Clinical Inertia, 1e. Cham: Springer International Publishing https://doi. org/10.1007/978‐3‐319‐09882‐1. Reidy, C., Kennedy, A., Pope, C. et al. (2016). Commissioning of self‐management support for people with long‐term conditions: an exploration of commissioning aspirations and processes. BMJ Open https://doi.org/10.1136/bmjopen‐2015‐010853. Sabaté, E. (2003). Adherence to long‐term therapies: evidence for action. Geneva: World Health Organization. doi: 10.2174/1389557511313020009.

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Tetley, A., Jinks, M., Huband, N., and Howells, K. (2011). A systematic review of measures of therapeutic engagement in psychosocial and psychological treatment. Journal of Clinical Psychology 67 (9): 927–941. https://doi.org/10.1002/jclp.20811. Thaler, R.H. and Sunstein, C.R. (2008). Nudge: Improving Decisions About Health, Wealth and Happiness, 1e. New Haven: Yale University Press. Trueman, P., Lowson, K., Blighe, A., Meszaros, A., Wright, D., Glanville, J., … Jani, Y. (2010). Evaluation of the scale, causes and costs of waste medicines final report. Retrieved from http://discovery.ucl.ac.uk/1350234/1/Evaluation_of_NHS_Medicines_Waste__web_ publication_version.pdf Wallcraft, J. (2010). The service user as a person in health care – service users organising for self empowerment. International Journal of Integrated Care 10 (5) https://doi.org/10.5334/ ijic.501.

Section I

Background

1

Treatment Engagement and Adherence A Review of the Literature Christiana O. Oshotse, Hayden Barry Bosworth, and Leah L. Zullig

Key Points • Medication adherence is a complex series of behaviors and encompasses three phases – initiation, implementation, and discontinuation. • Engaging patients and improving their treatment adherence requires consideration of factors across multiple levels (e.g. patient, provider, healthcare system) and phases of adherence. • Successful interventions to engage patients and improve adherence must be  tailored to deliver information that is relevant to a patient’s specific ­barriers, at the appropriate time, and in a manner that meets a patient’s unique health needs.

Introduction: Defining Treatment Adherence Adherence is a critical component of treatment effectiveness. For a treatment to improve quality of life, symptoms, and control disease it is important that treatments are followed as prescribed. As transitions from infectious diseases to chronic, non‐ communicable diseases occur, adherence has become a particularly salient issue. Management of chronic conditions may require long‐term adherence to therapies. Previously, treatment compliance, cooperation, and persistence were used to describe treatment adherence. More recent definitions of treatment adherence recognize the benefits of patient‐centered care with partnership between patients, their healthcare providers, and families and caregivers. Engaging patients, their families, and caregivers in the adherence process is key.

The Wiley Handbook of Healthcare Treatment Engagement: Theory, Research, and Clinical Practice, First Edition. Edited by Andrew Hadler, Stephen Sutton, and Lars Osterberg. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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Adherence is not simply one stage, but instead is a series of interrelated behaviors. In the context of adherence to medications, these behaviors have been defined in three quantifiable phases: initiation, implementation, and discontinuation (Vrijens et al. 2012). In this taxonomy, initiation is when a patient takes the first dose of a prescribed medication. Discontinuation is when a patient stops taking the prescribed medication, either according to a healthcare provider’s instructions, on their own, or for other reason. Implementation is the extent to which a patient’s actual medication‐ taking behaviors, or dosing, parallels what was prescribed from initiation to discontinuation (Vrijens et  al. 2012). While this taxonomy was designed to apply to medications, it can be used as a framework with which to view adherence to other types of treatments as well. The barriers and reasons for non‐adherence may vary across these phases (e.g. initiation, implementation, discontinuation). Different strategies may be needed to engage patients at each phase. Additionally, there may be different challenges in quantifying adherence across these phases. For example, it may be difficult to identify patients that never initiate a new medication that was prescribed by their provider (e.g. fill a prescription and begin taking it). In this chapter, we describe the magnitude of treatment non‐adherence, describe factors influencing treatment adherence, and summarize key adherence findings by phase of adherence.

Magnitude of the Treatment Adherence Problem Approximately half of patients with chronic diseases fail to adhere to prescribed medications in the United States, and these adherence rates are consistent across the globe (Sabaté 2003). More than one in five new prescriptions remain unfilled (e.g. initiation phase), and adherence to treatment therapy is lowest among patients who suffer from chronic illnesses (e.g. implementation phase) (Sabaté 2003). While overall adherence rates are approximately 50%, individual adherence varies by disease type, patient demographic characteristics, and other clinical characteristics (Briesacher et  al. 2008). Because of the complexity and duration of treatment, adherence is often lower among patients with multiple chronic conditions (Briesacher et al. 2008; Brown and Bussell 2011). For example, more than 60% of patients with cardiovascular disease are not adherent with their medications; suboptimal adherence is often more common among patients of disadvantaged socioeconomic backgrounds (e.g. uninsured or inadequately insured, low annual income, low health literacy, minorities). This worldwide problem of treatment non‐adherence presents enormous challenges to patients with chronic conditions, their providers and caregivers, and the healthcare system that is supporting them. Suboptimal adherence is associated with many negative outcomes – increased hospitalizations, lower quality of life, higher mortality, and increased potentially avoidable healthcare costs (Long et al. 2016; Sokol et al. 2005). Suboptimal adherence is also associated with substantial societal costs. Medication non‐adherence is a $300 billion problem in the US alone (Sokol et al. 2005). Each year, non‐adherent behaviors to treatment therapy are implicated in at least 125 000 American deaths (Osterberg and Blaschke 2005). Poor adherence is associated with increased

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­healthcare use; it contributes to a 17% increase in emergency room visits and a 10% rise in hospital stays in patients suffering from diabetes, asthma, and gastric acid disorders (Goldman et al. 2004).

Factors Influencing Treatment Adherence Factors influencing adherence are multifactorial and multilevel (e.g. patient, provider, healthcare system). The World Health Organization has categorized these factors into five domains  –  social and economic, healthcare system, therapy‐related, patient‐ related, and condition‐related (Sabaté 2003). Because patients’ needs span across these domains, factors influencing adherence should be considered holistically and longitudinal changes should be recognized. Effective solutions to improve treatment adherence must involve intervention across multiple factors and multiple levels (Zullig et al. 2013a). We will discuss each of these domains in the following sections.

Social and economic factors Social and economic factors that influence adherence encompass poor socioeconomic status (e.g. annual income and poverty), health literacy, educational attainment, social support, distance from healthcare, transportation accessibility, medication cost, and racial, ethnic, and cultural background, among other factors (Sabaté 2003). We will not describe the literature for each of these factors at length. Instead, we will provide a general overview and highlight a few more newly recognized factors (e.g. health literacy and chaotic lifestyle). Socioeconomic status  While economic and structural factors may impact a patient’s healthcare access, when evaluating the body of adherence literature, there is not a strong association between socioeconomic status and medication adherence (Alsabbagh et al. 2014; Falagas et al. 2008; Huang et al. 2013; Ungar et al. 2011). In fact, while low socioeconomic status may place patients at increased risk for suboptimal adherence, such patients are not guaranteed to experience adherence problems. When given access to medication adherence improvement and chronic disease management programs, patients from disadvantaged socioeconomic backgrounds may in fact have higher resilience and appreciation for medication adherence interventions than other groups (Bosworth et al. 2011; Jackson et al. 2012). Employment and education  Studies have identified that a patient’s occupation, educational background, and income may impact access to healthcare and healthcare quality, including treatment adherence (Falagas et al. 2008; Huang et al. 2013; Ungar et al. 2011). Because many working‐aged adults in the United States are insured through employer‐sponsored health plans, employment status is intertwined with access to care, prescription drug coverage, and cost of therapy (which is described below) (Long et al. 2016). Patients with low educational attainment may be unable to secure employment with good health insurance options and/or may have difficulty interpreting prescription medication labels and, therefore, are at greater risk for treatment adherence problems (Dal‐Fabbro 2005).

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Health literacy  Although educational attainment, literacy, and health literacy are separate constructs, they may all influence adherence. Health literacy is the ability to read and process health information and to make appropriate health decisions. Low health literacy is pervasive; up to 48% of English‐speaking patients have low health literacy (Andrus and Roth 2002). Low health literacy is associated with poor overall health status, underuse and misuse of preventative services, and increased hospitalizations and healthcare costs (Andrus and Roth 2002). In the context of medication adherence, there is a weak, but significant, association between low health literacy and suboptimal medication adherence (Loke et al. 2012; Zhang et al. 2014). Patients who are already disadvantaged (e.g. racial and ethnic minorities, those with low educational attainment and/or low‐income, and non‐native English speakers) may be most at risk for health literacy problems (Andrus and Roth 2002). Simple graphical instructions, such as pictorial calendars, may be one strategy to overcome low health literacy and boost treatment adherence (Zullig et al. 2014). Social support  Social support can be emotional, tangible (i.e. financial support or caretaking), or informational. When patients have adequate support that is well‐matched with their specific needs, they may be better equipped to overcome barriers to non‐adherence (e.g. providing transportation, spouse reminding patient to take their medications). Strong social ties are associated with increased survival for patients with chronic diseases, perhaps because they are better able to cope with stressors that may interrupt the adherence process (Criswell et al. 2010; Ozbay et al. 2007; Scheurer et al. 2012; Simoni et al. 2006; Strom and Egede 2012; Wu et al. 2013). A systematic literature review identified that 28% of included studies (14 out of 50 studies) examined the relationship between emotional support and medication adherence; of these 14 studies, 42% (6 out of 14) were identified as having a significant relationship between emotional support and medication adherence (Scheurer et  al. 2012). Most of the included studies showed a significant correlation between the provision of tangible means of support and medication adherence (Molloy et al. 2008; Scheurer et al. 2012). Tangible social support was effective in addressing systemic barriers such as inability to afford medication and difficulty reaching healthcare sites. Examples of tangible social support include paying for medications, providing transportation, and providing physical assistance when necessary (Ford et al. 1998; Heaney and Israel 2008; Strom and Egede 2012; van Dam et al. 2005). Prescription medication cost  Especially for patients who are under‐ or un‐insured, the cost of prescription medications can be an adherence barrier. Express Scripts (at the time of this writing is the largest pharmacy benefits management organization in the US) reports that the average price for the most commonly used brand‐name drugs in the US more than doubled (up 127%) between 2008 and 2014 (Miller 2016). Increased drug spending resulted from higher prices for specialty and biotech therapies and from the use of medications for a wider range of conditions and over longer periods of time (Eaddy et al. 2012). The cost of prescription drugs continues to rise because of lack of price controls, long waits to establish patents on drugs, limited competition among drug makers, developmental and production costs, and fewer generic medications on the market (Johnson 2015). Several research studies have demonstrated that patients are sensitive to even small adjustments in co‐payment costs and that reducing or eliminating out‐of‐pocket costs for prescription medications is associated with improvements in medication adherence

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(Choudhry et al. 2008, 2011; Dusetzina et al. 2014; Ito et al. 2015). In a survey of over 14 000 Medicare beneficiaries, patients who chose not to fill at least one prescription reported reasons such as “thought it would cost too much” (55.5%), “medicine not covered by insurance” (20.2%), and they “didn’t think medicine was necessary for the condition” (18.0%) (Kennedy et al. 2008). The use of oral anticancer drugs serves as an example of cost‐related medication non‐adherence. Innovative biologic treatments come with high price tags that may limit accessibility. Oral anticancer medications can average as much as $7000 per month (Dusetzina 2016). Prescription medication costs have a significant impact on treatment adherence. Among patients with cancer who were receiving cancer care at a tertiary center, 27% of patients reported at least one form of medication non‐adherence: skipping medications to extend prescriptions, taking less medication to extend prescriptions, or failing to fill a prescription because of the cost (Bestvina et al. 2014). There have been several studies focusing on increasing prescription medication coverage and reducing patients’ out‐of‐pocket costs to improve medication adherence. While providing full coverage seems to improve medication adherence, this improvement does not necessarily equate to improvements in clinical outcomes (Choudhry et al. 2011; Njie et al. 2015), but may be associated with improvements in quality of life and reduced hospitalizations (Ito et al. 2015). A systematic review addressed the impact of 18 interventional studies designed to reduce patients’ out‐of‐pocket costs for medications to manage hypertension and hyperlipidemia. Adherence improved by a median of 3% and the proportion of patients achieving an adherence rate of 80% or more increased by 5.1% (Njie et  al. 2015). While the effect sizes are small, when applied at the population level, even small improvements in medication adherence can have a meaningful impact on a population scale. Racial, ethnic, gender, and  cultural background  Patient characteristics, such as race and gender, may interact with other factors to influence a patient’s medication‐taking behaviors. For patients of minority racial and ethnic groups, perceived discrimination and trust or mistrust of healthcare providers and the healthcare system may moderate intervention effects and impact medication adherence behaviors (Dal‐Fabbro 2005; Erwin and Peters 1999). Similarly, several studies have identified associations between gender and adherence, but the directionality of the association is uncertain. Some studies suggest that women are more adherent than men (Balbay et al. 2005; Choi‐Kwon et al. 2005; Deeks et al. 2009; Fodor et al. 2005; Lertmaharit et al. 2005; Manteuffel et  al. 2014), whereas other studies have suggested men are more adherent (Goldstein et al. 2016; Lauffenburger et al. 2014; Pearson 2013). Because men and women may have different healthcare‐seeking behaviors and may interact with the healthcare system differently, gender may also play a role in treatment‐effect heterogeneity. It is important to note that these characteristics do not occur in a vacuum but instead interact to influence a patient’s experience of adherence to medications.

Healthcare system factors At a healthcare system level, reimbursement and health insurance coverage, medication distribution systems, knowledge, training and capacity of healthcare providers, and system capacity all influence treatment adherence (Sabaté 2003). While patient– provider communication is an important factor in the treatment adherence equation

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(Beach et  al. 2015; Zullig et  al. 2015), the largest body of literature regarding healthcare system factors and adherence addresses reimbursement and insurance coverage. Healthcare policies and prescription medication insurance impact treatment access and cost. In the US, there are multiple avenues for offsetting out‐of‐pocket medication costs. Patients can receive assistance purchasing their prescription medications through medication subsidies, prescription caps, insurance benefits (e.g. co‐ insurance and cost sharing plans) and supplemental prescription drug coverage plans (Aziz et  al. 2016). Value‐based insurance designs, which were created to reduce access barriers to healthcare services while also de‐incentivizing inefficient healthcare practices through high cost sharing, are increasingly common (Fendrick et  al. 2010). Patients lacking insurance are more likely to not take medication as prescribed and are more than two times as likely to use alternative therapies; Medicare beneficiaries are more likely to buy prescription drugs from another country (Cohen et al. 2013). In response to the mounting prescription drug costs, public and private insurers have become selective in certain drugs and the extent of coverage they offer for prescription drugs. In 2012, 16 states imposed limits on the number of drugs Medicaid recipients could receive, with states such as Arkansas, California, Kansas, Louisiana, North Carolina, and Texas opting to restrict the list of drugs they covered (Galewitz 2012). These policy changes have potential to impact patients’ initiation and persistence with medication regimens.

Therapy‐related factors Therapy‐related factors include the complexity and duration of the regimen, previous treatment failures, changes in the regimen, side effects, among other factors (Sabaté 2003). Concurrent treatment for multiple conditions increases treatment complexity, which in turn may make paying for and correctly implementing medications particularly challenging. An example of treatment complexity is polypharmacy (e.g. prescribed three or more daily medications); 30–40% of elderly patients take five or more medications (Furberg et  al. 2010). Routine medication review among patients using multiple medications could reduce inappropriate or duplicative prescribing, thus reducing patients’ medication‐taking burden, and improving adherence (Tarn et al. 2009). Interventions have successfully reduced inappropriate prescribing and polypharmacy among the elderly using a variety of strategies (e.g. medication review), but these interventions have not clearly impacted measured outcomes (e.g. hospital admissions) (Christensen and Lundh 2013; Cooper et al. 2015). Another strategy to reduce the burden of polypharmacy is medication packaging systems, such as blister packs. Systematic reviews confirm that blister packaging, reminder packaging, and calendar packaging improve medication adherence (Conn et al. 2015; Mahtani et al. 2011; Zedler et al. 2011). Compared to other intervention strategies to improve adherence (e.g. increasing coverage to reduce patients’ out‐of‐ pocket costs), medication packaging may be a relatively low cost solution to address many common adherence barriers. Packaging strategies may be particularly helpful in the context of polypharmacy where remembering complex medication regimen instructions may be challenging.

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Patient‐related factors Patient‐related factors include knowledge, attitude, beliefs, perceptions, expectations, and resources (Sabaté 2003). Many patient‐related factors are centered around a patients’ belief system about their health and healthcare. Health beliefs  The Health Belief Model (HBM) is one framework in which to consider these patient‐related factors. The HBM posits that a person’s health behaviors are determined by their understanding of the perceived threat and benefits of diseases and treatments (Bosworth and Voils 2012; Dal‐Fabbro 2005; Erwin and Peters 1999; Gatti et al. 2009). Culture, religion, ethnicity, and other spheres of relation influence individuals’ health beliefs and practices. An individual’s understanding of the seriousness and risks associated with the disease or treatment and the benefits and barriers to treatment impacts adherence (Bosworth and Voils 2012). The HBM additionally includes cues to action, motivating factors, and self‐efficacy as concepts that influence an individual’s health belief system. Health beliefs have been associated with adherence behaviors in several clinical conditions including transplantation and management of dyslipidemia (Al Hamid et al. 2014; Buckley et al. 2016; Kung et al. 2012; Shiyanbola et al. 2013; Zullig et al. 2016). Adhering with treatment recommendations is largely based on a patient’s perceptions of the benefits of the treatment. Patients who view the potential benefit of treatment as outweighing their perceived negative consequences are more likely to adhere (Hayden 2014). High self‐efficacy, a patient’s belief in themselves to follow through with an action, is also associated with better adherence (Bosworth and Voils 2012; Chlebowy and Garvin 2006; Hayden 2014). Successful strategies to shape and change patients’ health beliefs and promote treatment adherence include health coaching (Wolever et al. 2010), shared decision‐ making, and motivational interviewing. Healthy adherer effect  Related to health beliefs is a concept coined the “health adherer effect,” also known as “compliance bias.” A meta‐analysis reported an association between adherence to a placebo and improvements in mortality (Simpson et al. 2006). The authors suggested that adherence to medications may be a proxy measure for general healthy behaviors. In other words, people who are adherent may exhibit different health beliefs which impact their lifestyle behaviors. These health beliefs may be different among adherent and non‐adherent patients. In fact, adherence to placebo has been associated with improved clinical outcomes and mortality in several studies (Avins et al. 2010; Curtis et al. 2011; Simpson et al. 2006). Traditionally, most studies have not considered the potential for a health adherer effect in their study design or interpretation of results. This may be an avenue for future research. Chaotic lifestyle  A non‐traditional patient‐related factor influencing adherence is a chaotic lifestyle. Having a chaotic lifestyle, including the lack of flexibility to schedule medical appointments, may be an important barrier to obtaining regular medical care and has been associated with suboptimal medication adherence among post‐myocardial infarction patients and those with HIV/AIDS (Wong et al. 2007; Zullig et al. 2013b). Life chaos may be a modifiable determinant of medication adherence and represents opportunity for further research that seeks to address the structural and individual stressors that negatively impact patients’ ability to adhere.

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Condition‐related factors Condition‐related factors include burdens placed on patients that are specific to their disease(s) or condition(s). According to the WHO, these factors include severity of symptoms, level of disability, rate of disease progression and severity, as well as the availability of effective treatments (Sabaté 2003). Comorbidities (e.g. depression, diabetes, HIV/AIDS, drug and alcohol abuse) may be condition‐ related factors that are likely to modify treatment adherence behaviors (Sabaté 2003).

Medication Adherence in the Context of Three Adherence Phases The factors influencing treatment adherence have been well documented, and there are many evidence‐based interventions to improve adherence (Gellad et  al. 2011; Nieuwlaat et al. 2014; Sabaté 2003). Traditionally, adherence has often been viewed as a single behavior or event. Among the adherence research community, there is an increasing recognition of the need to frame and describe adherence interventions within the framework of the phases of medication adherence (e.g. initiation, implementation, discontinuation) (Helmy et al. 2017; Vrijens et al. 2012). In the following sections, we describe methods for measuring adherence, studies to improve adherence, and approaches to engage patients and their caregivers in healthy adherence behaviors in accordance with the three adherence phases.

Measuring medication adherence There are many direct and indirect methods of measuring adherence which include subjective and self‐report assessments, pill counts, electronic monitoring (e.g. smart pill bottles and caps, and ingestible pill sensors), log books and diaries, and pharmacy‐based and claims measures, among others (Clifford et al. 2014). While there is no gold standard for measurement, a combination of direct and indirect methods is often best (De Geest et al. 2014). Additionally, interventions that seek to improve adherence must take a multilevel approach, integrating strategies at the patient, provider, and other levels (De Geest et al. 2014). Thus, decisions about approaches for measuring adherence should consider the context, intended purpose, available resources for measurement, and phase(s) of adherence that are of interest (Zullig et al. 2017). Some measures may be better suited for measuring adherence at different phases than others. For example, pharmacy and claims measures may be very informative for evaluating persistence with a medication regimen over time, but may be unable to detect medications that are never initiated (e.g. first prescription is never filled).

Existing interventions by adherence phase As measurement strategies vary by adherence phase, so too do many barriers and  intervention strategies to overcome them. We describe a purposive sample of

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interventions by phase (e.g. initiation, implementation, discontinuation) that have successfully improved adherence (Vrijens et al. 2012). Initiation phase  Researchers at an integrated healthcare system conducted a randomized controlled trial to improve non‐initiation of bisphosphonate therapy for osteoporosis (Cizmic et al. 2015). Adults with a new bisphosphonate order that was not filled within 14–20 days were randomized to either a control group (e.g. no o ­ utreach) or an intervention group. The intervention group received an interactive voice response phone call. If patients did not initiate therapy within one week, a follow‐up letter was mailed. Approximately 31% of patients in the control group and 49% of patients in the intervention group initiated bisphosphonate medication within 25 days of study randomization. When adjusted for demographic and clinical characteristics, the odds ratio for initiation in the intervention versus control group was 2.3 (95% CI 1.34–3.94) (Cizmic et al. 2015). This suggests that an interactive voice response and follow‐up letter system may be helpful to improve initiation of new therapies such as bisphosphonates. It is worth noting that, relative to available interventional literature in the implementation phase, less is known about strategies to improve initiation. A partial explanation for this is that identifying non‐initiators can be challenging. Studies of initiation are often limited to integrated healthcare systems and/or countries that have integrated, single‐payer systems (Cizmic et al. 2015; Halvorsen et al. 2016). Implementation phase  The bulk of interventions to improve adherence have focused on the implementation phase, the extent to which a patient’s actual dosing corresponds to the prescribed dosing regimen, from initiation until the last dose is taken (Vrijens et  al. 2012). While a variety of intervention strategies have been used to improve adherence (Nieuwlaat et al. 2014), we will describe two randomized controlled trials – a full coverage, cost‐reducing trial (Choudhry et al. 2011) and a multifaceted, pharmacist‐led intervention (Ho et al. 2014). Choudhry and colleagues enrolled patients recently discharged from the hospital post‐myocardial infarction clinic and randomly assigned their insurance plan sponsors  to full prescription coverage or usual prescription coverage for statins, beta‐ blockers, angiotensin‐converting‐enzyme inhibitors, or angiotensin‐receptor blockers (Choudhry et al. 2011). The primary outcome was a major vascular event or revascularization, and medication adherence was a secondary outcome. While there was no improvement in the primary outcome, medication adherence (e.g. mean medication possession ratio calculated from pharmacy data) was improved for all drug classes (e.g. ACE inhibitors or angiotensin‐receptor blockers, beta‐blockers, and statins). Across all three medication classes, the odds of full adherence to the study medications significantly increased by 31–41% (p 1y

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Figure 3.2  Range of responses from a surgical care seminar.

a life‐limiting disease and are being asked to decide between two treatments. Both  treatments are approved by the National Institute for Health and Care Excellence (NICE) on the basis of best research evidence (NICE approves healthcare ­interventions for use in the UK’s National Health Service). Both treatments offer benefits. But both also come with snags. So, what would your minimum period be to choose Treatment A over the 50 : 50 Treatment B? The easy way to answer this question is to slip into generalities: “what minimum period would people in general choose?” But to get the point of the exercise try to avoid such generalities and answer the question for yourself at your present age and in your present circumstances: “what minimum period would I choose?” Write your personal answer down in the space provided and then add your reasons. Like Exercise 1 the Forced Choice exercise provokes a wide range of responses. This is because both exercises tap into the diversity of our values. A typical distribution of responses is shown in Figure 3.2. This is from a seminar in values‐based ­surgical care. Responses in this seminar ranged from very short to very long periods with some opting for the 50 : 50 Treatment B no matter what. If you did the exercise see where your chosen period would come in this range. You may be surprised at how differently other people respond. But in feedback most groups quickly get the point. They quickly see for themselves that their range of answers reflects the diversity of their values, of what matters or is important to them: people with young families for example often opt for a minimum of 20 years or so because they “want to see their children safely grown up”; others choose much shorter periods where they have a key project (e.g. a PhD) to finish. Exercise 2 thus reinforces the message of Exercise 1 about the diversity of individual values. But it takes the message further by linking it up directly with the evidence base of clinical decision‐making. Everyone trying Exercise 2 is presented with the same evidence base but they choose differently because they have different values bases. And just how this or that person will respond is difficult to second‐guess: even people who know each other really well are often surprised about each others’ choices. Being surprised in this way was a light‐bulb moment for two surgical trainees, Zoe and Tom, in the first of a series of seminars in values‐based surgical care.

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Zoe and tom’s story Zoe and Tom had been through medical school together and were planning to get married. Both were ex‐prize‐winning Oxford medical students. They had read up on values‐based practice and had played a leading role in organizing the seminar. But they had never tried the forced choice exercise for real. Sitting side‐by‐side in the seminar they were thus much surprised to find that they came up with very different answers. Zoe’s minimum was 25 years; but Tom’s was only 18 months! Zoe described her experience in a subsequent publication (Handa et al. 2016): The forced‐choice exercise was a “light bulb moment” for me. I was sitting next to my partner of 6 years who is also a trainee surgeon and from a similar background to mine. We often discuss difficult clinical decisions at home and I feel that we share similar ­outlooks and ambitions. However, his “value for X” (18 months) compared to mine (25 years) completely astounded me. If I could misjudge the values of the man I share my life with so profoundly, just how wrong might I be in assuming that I know what is important to my patients? He went on to explain his answer, which I fully understand and agree with. But I realized that unless we ask we will never know what matters to each other.

Zoe’s account of her experience goes to the heart of why values‐based practice is important for patient engagement. The Forced Choice exercise brought home to Zoe that as a doctor she could not second‐guess what was important to her patients. She had to find out. Only by finding out, by actually asking her patients, could she understand, and hence engage with, what was important to them. Otherwise she risked misunderstanding and disengagement. The rest of Part II provides an overview of values‐based practice and how its elements severally and together link science with people as the basis of patient engagement. How all this works out in practice is described in Part III.

An outline of values‐based practice The process of values‐based practice is shown diagrammatically in Figure 3.3 and its elements are summarized in Figure 3.4. As these indicate the premise of values‐based practice is mutual respect for differences of values. Its process has 10 elements covering clinical skills, relationships, links with evidence‐based practice, and a particular take on partnership in decision‐making. Its outputs are balanced decisions made within frameworks of shared values.

Premise of mutual respect for differences of values Ten key process elements • 4 clinical skills • 2 aspects of clinical relationships • 3 principles linking VBP and EBP • Partnership based on dissensus

Together these support Balanced decisions

made within frameworks of shared values

Figure 3.3  Diagram of values‐based practice.

Values‐based Practice and Patient Engagement Values-based practice PREMISE Mutual respect

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Brief definition Mutual respect for differences of values

TEN PROCESS ELEMENTS Four clinical skills: 1) Awareness 2) Knowledge 3) Reasoning

Awareness of values and of differences of values Knowledge retrieval and its limitations Used to explore the values in play rather than to close down on ‘right answers’ Especially for eliciting values and of conflict resolution 4) Communication Two aspects of clinical relationships: Care centered on the actual rather than assumed 5) Person-values-centered values of the patient care MDT role extended to include values as well as 6) The extended MDT knowledge and skills Three principles linking VBP and EBP: All decisions are based on the two feet of values and 7) Two feet principle evidence We notice values when they cause difficulties (like the 8) Squeaky wheel principle squeaky wheel) but (like the wheel that doesn’t squeak) they are always there and operative Advances in medical science drive the need for VBP 9) Science-driven principle (as well as EBP) because they open up choices and with choices go values Partnership in decision-making Partnership in decision-making based on the values of 10) Partnership based on those concerned remain in play to be balanced dissensus sometimes one way and sometimes in other ways according to the circumstances of a given case OUTPUTS Frameworks of shared values Balanced decisions within frameworks of shared values

Values shared by those concerned in a given decision making context (e.g. a GP Practice) and within which balanced decisions can be made on individual cases Decisions made by balancing the relevant shared values according to the circumstances presented by the case in question

Figure 3.4  Summary of the elements of values‐based practice.

Values‐based practice and patient engagement are clinically coextensive. The premise of values‐based practice in mutual respect for differences of values is a premise equally for patient engagement. Without mutual respect the engagement between Mrs. Jones and Mr. Patel described above would not have got off the ground. The outputs of values‐based practice and of patient engagement are similarly aligned in that both depend on shared decision‐making. Again, the decision to go for conservative treatment in the story of Mrs. Jones’s knee was a shared decision between her and Mr. Patel. And it is shared decision‐making as the basis equally of values‐based ­practice and of patient engagement that is delivered by the skills and other process elements of values‐based practice.

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The rest of this section gives further details of the process elements of values‐based practice. As you read through these you may find it helpful to refer back to the ­diagram of values‐based practice and accompanying summary in Figures 3.3 and 3.4. Additional examples of the links between these process elements and patient ­engagement are given in Part III and in Section 3.5 at the end of the chapter.

Values‐based clinical skills The importance of the clinical skills of values‐based practice for patient engagement is illustrated by the story of Mrs. Jones’s knee. Raised awareness of values was (as in all values‐based practice) the starting point. Mr. Patel in Mrs. Jones’s story showed awareness of values in good measure. But Mr. Patel also showed excellent communication skills: his listening skills were fully in play in the way he picked up on Mrs. Jones’s throw‐away (but crucial) comment about gardening as she was getting ready to leave. Reasoning about values (using for example case‐based reasoning), although not involved in Mrs. Jones’s story, may be helpful in supporting raised awareness of ­values. Reasoning skills are used in values‐based practice not to close down on “the right answer” but rather to widen values horizons. Knowledge of values – whether from experience or research – may also be helpful: it is often helpful to know for example what kind of values may be in play in a given situation. Knowledge of this kind comes with a “health warning” however that is illustrated by Mrs. Jones’s story. Mr. Patel and others involved in her assessment knew from experience that most people with arthritic knees want to get rid of the pain. As a consequence they had assumed that Mrs. Jones was like most people in her situation. But she was not. So the “health warning” about knowledge in values‐based practice is that when it comes to values everyone is a potential “n of 1” (Fulford et al. 2012, Chapter 6).

Values‐based clinical relationships Patient engagement, as was noted at the start of this chapter, means engaging with patients’ values. But patients’ values (our values), as Exercises 1 and 2 both indicated, are individually diverse. So we need the skills and other resources of values‐based practice to support patient engagement just in that patient engagement means engaging with the diverse values of our patients as unique individuals. But this is precisely what person‐values‐centered practice, as the first of the two clinical relationships important for values‐based practice, is all about. So understood, therefore, patient‐ values‐centered practice is equivalent in all but name to patient engagement. The extended multidisciplinary team, as the second of the two clinical relationships of values‐based practice, is important as a key delivery mechanism for person‐values‐ centered practice and by extension for patient engagement. Multidisciplinary teams are the norm nowadays in most areas of healthcare. This is because multidisciplinary teams bring a range of knowledge and skills to clinical care. Values‐based practice extends the role of the multidisciplinary team to include values. The importance of this extended role for engaging with patients’ values is illustrated by the following account from a radiologist, Jill (not her real name), of how her role had become extended in a breast surgery clinic (Handa et al. 2016).

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As a radiographer I can offer a listening ear in a relatively informal setting. The patients I see often find it easier to talk about what matters to them in the more  relaxed setting of the practical procedures of imaging rather than being “interviewed” in an outpatient clinic. However, I do worry about “saying the wrong thing” when patients ask my opinion, so I tend to reflect their questions back to them.

Jill’s experience as a radiographer is typical of many team members. The authority of “the doctor,” important as it may be in other respects, is intimidating for many patients. This is one of the factors noted at the start of this chapter that may lead to  patient disengagement. The communication challenges are compounded in ­situations like breast surgery clinics where a patient may be struggling to take in a life‐limiting diagnosis. In such circumstances as Jill describes the opportunities offered by other team members may be crucial for a patient to talk about what really matters to them. Jill’s final comment, however, also shows how medical authority may stand in the way of other team members performing their values‐extended role effectively. As a radiographer Jill was worried about what to do with what her patients told her. This is one reason why wherever possible training in values‐based practice is organized inter‐professionally (Handa et al. 2016). The training aims to give all team members an understanding of this further aspect of their role and the confidence to work with it effectively.

Values‐based and evidence‐based practice The close relationship between values‐based and evidence‐based practice has already been emphasized. You will have recognized this for yourself if you tried the Forced Choice Exercise 2 at the start of this part. The three principles constituting elements 7–9 of values‐based practice (see Figure 3.4) draw out and emphasize three specific aspects of the relationship. Thus the “two feet” principle reminds us that all clinical decision‐making stands of the 2 feet of evidence and values. This is important where the relevant values may be for one reason or another (relatively) hidden. The values involved in decisions about diagnosis for example (in the broad sense of how a problem is understood) may be vitally important in relation to long‐term and complex conditions (for an example of this, see Fulford et al. 2015b). The “two feet” principle thus reminds us clinically to “think evidence, think values too!” The “squeaky wheel” principle, conversely, reminds us that it is no less important to “think values, think evidence too!” The “squeaky wheel” is a reference to the saying “it’s the squeaky wheel that gets the grease.” In other words we notice values when (like the squeaky wheel) they are causing trouble. But the other wheels (the evidence wheels in this extended metaphor) are no less important for keeping the vehicle on the road. The “squeaky wheel” is at work for example in ethical dilemmas. A dilemma is an ethical dilemma just in that the ethical values in question are at issue. Thus with the ethical values holding our attention (with the ethical values “­squeaking”) it is understandable that the evidence tends to get neglected. But the result is that

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clinical decisions end up being driven by ideological positions rather than by the ­balanced evidence‐plus‐values approach of values‐based practice. The third principle, the “science‐driven” principle, brings the first two principles together in the context of high‐tech medicine. Given the power of medical science and technology to improve clinical care it is perhaps natural to assume that “more science means less values.” Science, so this assumption acknowledges, may generate ethical dilemmas (as in genetic medicine). But with enough science, with a clear enough evidence‐base, so this assumption continues, the need to bring values into clinical decision‐making will disappear. To the contrary replies the “science‐driven” principle! “More science actually means more values!” Why? Because the impact of advances in science and technology on clinical care is to open up new choices for patients and with choices goes the diversity of individual people’s values. Again, Mrs. Jones’s knee makes the point. It was not for lack of evidence that Mrs. Jones ended up choosing differently from most people with arthritic knees. To the contrary it was precisely because Mr. Patel was able to offer Mrs. Jones clear evidence‐based alternatives that her particular values (putting gardening before pain relief) were able to come into play. Just as science drives the need for evidence‐based practice, therefore, so too, the “science‐driven” principle insists, does science drive the need for values‐based practice.

Values‐based partnership in decision‐making The final element of values‐based practice is a particular take on shared decision‐­ making called “dissensus.” As an element of the process of values‐based practice dissensus is crucial to its outputs in balanced decisions within frameworks of shared values. As such it will be worth considering in a little more detail before turning to implementation in Part III. Dissensus is best understood by contrast with consensus. Consensus is achieved by one or other party giving up their position. Evidence‐based practice is underpinned by consensus where for example meta‐analyses are used to sift complex and conflicting evidence to deliver a consensual position. Values‐based practice by contrast is underpinned by dissensus. As already described the skills and other elements of ­values‐based practice support balanced decision‐making within frameworks of shared values according to the particular circumstances presented by a given case. For the case in question therefore one value inevitably loses out in the balancing process to another. But instead of the “losing” value dropping out, the framework of values as a whole remains in play to be balanced sometimes in the same way and sometimes in different ways in subsequent cases. A clear if rather extreme example of how balanced dissensual decision‐making of this kind works in practice is provided by involuntary psychiatric treatment. Such treatment in being involuntary necessarily involves conflicts of values. Not much scope for patient engagement then you may think. And indeed a wide‐ranging public consultation carried out in the run‐up to the launch of the UK’s recently revised legislative framework for involuntary psychiatric treatment (the 2007 Mental Health Act, see Department of Health 2007) proved to be highly contentious (Fulford et al. 2015a). The consultation however also revealed a number of shared values. These shared values, therefore, understood through the lens of values‐based practice, thus formed a framework that could be used to support balanced decision‐making under

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the Act. They were accordingly incorporated in the Act’s accompanying Code of Practice as a set of “Guiding Principles.” The Guiding Principles in turn formed the basis for values‐based training materials produced by the Department of Health to support implementation (see next paragraph for a link to the training materials). Figure  3.5, which is derived from these training materials, shows the Guiding Principles diagrammatically as a “round table” of shared values. The point of a round table is that no one has precedence. In applying the Guiding Principles therefore they have to be balanced one against another according to the circumstances presented by the case in question. But the principles are individually complex and jointly conflicting: the Respect Principle for example is complex in the sense that it means different things to different people; it is also inherently in conflict with for example the Purpose Principle since the purpose of the Act (involuntary treatment) necessarily involves failing to respect (in this area at least) the patient’s values. This is where values‐based practice comes into play. The process of balancing the Guiding Principles in a given case requires the skills and other elements of values‐based practice. The process over a series of cases is dissensual in that the Guiding Principles as a framework of shared values remain fully in play to be balanced sometimes one way and sometimes in other ways according the circumstances presented by each case. (The workbook is available as a full text download from the website of the Collaborating Centre for Values‐based Practice at: http://valuesbasedpractice.org/more‐about‐vbp/full‐text‐downloads and scroll down to “Foundation Module for the Workbook to support Implementation of the Mental Health Act 2007.”)

t Respec le Princip

Le Alte ast R rna estr ic tive Prin tive cip le

Purpose Principle

Values-based Practice

s ce ur le so cip Re rin P

n tio ipa le c i t p i r Pa rinc P

Figure 3.5  The guiding principles as a framework of shared values.

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Part III – Implementing Values‐based Patient Engagement Patient engagement, Part I of this chapter suggested, is about engaging with the values of individual patients. Part II gave examples of how the skills and other elements of values‐based practice support patient engagement so understood. But how does values‐based patient engagement work out in everyday practice? This final Part III of the chapter looks at how you can apply values‐based practice to support patient engagement in the context of your own clinical work. This is what the exercise in Box 3.3 is about.

Exercise 3: Tweak my practice As with the earlier exercises in the chapter the challenge is to “make it personal.” Implementing change in healthcare all too often means “someone has to do something!” This exercise asks you to think in first‐personal terms about “what can I do?” Notice also that the task is to come up with just a tweak. Again, it is easy to slip into grand schemes that although worthy aspirations are unlikely ever to be realized: they may for example place unrealistic burdens on over‐stretched resources of money or time, or require “buy in” from others who may or may not be supportive. So the idea of the exercise is to come up with a small but do‐able change  –  a tweak – something, however small, that being within your control and/or the control of your immediate colleagues will be effective in shifting your practice toward a more values‐based approach to patient engagement. This is very much an area where “learning by doing” is really effective. So try this for yourself before reading on. Your ideas may anyway be much better than the examples that follow! In thinking about your own tweaks you may find it helpful to refer back to the diagram and summary of values‐based practice given in Figures 3.3 and 3.4 above. Don’t forget that raised awareness (skills element 1) is the foundation. But try running through the other elements as well, thinking how you might adapt them as tweaks in the context of your own practice. Review what resources/supports you can call on; but also the likely barriers. Take your time to think through all this. If you are working in a group try discussing your ideas together with colleagues and/or patients. There is a space in Box 3.3 for you to write down your ideas.

Box 3.3  Exercise 3: A Tweak to My Practice In this exercise the aim is to identify ways in which you can bring values‐based practice into your own work. 1. Think about your own practice and the cases you see routinely every day. 2. Write down one small change you could make to improve your own values‐ based practice: this should be a small change (a “tweak”), i.e. something you can do for real. Please write your tweak here:

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A Tweak in Surgical Outpatients  Exercise 3 brings out a number of points about the realities of values‐based practice in everyday clinical care. Some of these are set out below. For now the key point is that, as the name of Exercise 3 suggests, a small shift, a tweak, in the direction of values‐basing your practice can often make a big difference to patient engagement. As noted above small do‐able tweaks of this kind are in fact often more effective than grand plans. In the following account a vascular surgeon describes a tweak made as a result of training in values‐based practice (Handa et al. 2016). The setting is a busy vascular surgical outpatient clinic.

For me the crunch comes clinically when a patient asks “what would you do doctor?” Sometimes we have the luxury of unambiguous evidence‐based advice. I find most clinical decision‐making is in gray areas where discussion often comes down to the patient not unreasonably asking: So what would you do doctor? And I wouldn’t want to duck that. It’s not helpful to patients to push the decision back to them. As surgeons, after all, we have considerable experience of how different options work out in practice: this can help a patient who is trying to make difficult choices in the context of facing potentially life‐limiting diagnoses. But it’s also not helpful to push our own decisions willy‐nilly. This is what patient feedback from the workshops suggests we have been too inclined to do. It is what I now realize I have been in effect doing. What these workshops have brought home to me is that my answer to “what would you do?” has reflected my own values not those of the patient. So we may think we are being patient‐centered but we end up being clinician‐centered. Of course, it’s not easy. But instead of just replying with this or that option (however obvious it seems to me) I now start by finding out more about what matters to this patient. Then I’m better able to look at what “I” would do in terms of what matters from their point of view rather than from mine. So now when asked “what would you do doctor?” my answer starts with “well, that depends on what is important to you?” The dialog then develops from there.

“I don’t have time for all this”  As an exemplar of values‐based tweaking this account dispels a number of myths about values‐based practice. One such myth is “I don’t have time for all this.” This “tweak” certainly takes a few extra minutes to talk through what matters to his patients. But this adds relatively little to the overall time he and his team spend with a given patient and it pays off in time saved later. Mr. Patel’s extra few minutes with Mrs. Jones (above) was similarly an excellent investment set against the time (his time and the time of the surgical team and others involved) in pressing ahead with a misdirected operation – not to mention the further time involved for everyone in dealing with a disengaged and indeed dissatisfied Mrs. Jones, who would likely have been on the war path at the end of it all. “I do it already!”  Another myth about values‐based practice is that “I do it already!” There is a basis of truth in this myth in that values‐based practice is in a sense nothing more than just good practice. Again, the story of Mrs. Jones’s knee makes the point. The “tweak” described in vascular surgical practice was a direct outcome of training

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in values‐based practice (particularly of doing the Forced Choice exercise). Mr. Patel, by contrast, in dealing with Mrs. Jones had (at the time) never heard of values‐based practice, still less had any training in it. Yet his alertness to what really mattered to Mrs. Jones and the shared decision‐making that flowed from this were pure values‐ based practice. Good practice of this values‐based kind is also consistent with the law and guidance noted below. So, yes, values‐based practice is nothing more than just good practice. But it is also nothing less. For good practice, if patients’ experiences are any guide, is very far from the norm. This came out clearly in a seminar in values‐based practice and breast surgery. The seminar included both surgical teams and representatives of a local patient group called BRA (Breast Reconstruction Alliance).

In the course of the seminar an experienced breast surgeon, Miss Davies (not her real name), gave what amounted to an off‐the‐cuff master class in values‐based practice describing how she worked with her patients facing breast surgery. Her point was precisely that “we do it already.” But patients from the BRA group were quick to counter that while Miss. Davies’s practice was indeed exemplary it was also exceptional. Most breast surgeons behaved in a very different and far less person‐ centered way.

Building on good practice  So values‐based practice is not about inventing some new form of good practice. It is about building on and extending existing good practice. The UK’s medical regulator, the GMC (General Medical Council) has for many years advocated what amounts to values‐based shared decision‐making (General Medical Council 2008). A recent UK Supreme Court judgment makes the GMC’s line on good practice the basis of consent to treatment (Montgomery v Lanarkshire Health Board 2015): the Montgomery judgment as it is called, although a ruling of the UK Supreme Court, draws on a range of precedents from international law reflecting similar shifts in ethical, legal, and clinical thinking in other parts of the world toward shared decision‐making as the basis of consent. (Richard Huxtable describes the judgment in more detail in Chapter 4 of this book.) In a similar vein, NICE, the body responsible for producing evidence‐based guidelines for the UK’s National Health Service, requires that those using its guidelines should take into account patients’ individual “needs, preferences and values” (see for example https://www.nice.org.uk/guidance/cg181). Two tests of “do‐ability”  Yet such practice, as already noted, remains the exception rather than the rule. This is why training in values‐based practice is needed: not to establish but to build on established good practice. If you found the final “tweak” exercise difficult you are not alone. In values‐based training this is always the part that participants find most difficult. Opening our minds to the diversity of values (as in Exercise 1) is relatively easy. Understanding how deeply this diversity influences the outcomes of evidence‐based clinical decision‐making (as in Exercise 2) comes as a surprise, though on reflection it makes sense. But taking the further step of translating principle into practice, as the “tweak” Exercise 3 requires, always proves considerably more challenging.

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• • • • •

Listen to the patient and what they actually want Ensure they understand why they are there Answer patient’s questions Try to change things for the better Ask the patient if they have had imaging before and then follow-up on this question in the way you explain/approach the examination • Need to consider time v quality • Ask the patient about the best time of day for their examination/appointment • Is there an alternative treatment?

Figure 3.6  Tweaks from a seminar in values‐based radiography.

Figure 3.6 gives a sample of “tweaks” from a seminar for radiographers that, like the surgical seminars noted above, focused on raising awareness of values. These are clearly patient‐focused but at the same time most pass the two key tests of “do‐ability” required of an effective “tweak.” Most of the changes in Figure 3.6 (e.g. agreeing a mutually convenient time for an appointment) flow naturally out of and extend participants’ everyday practice. Most of the changes can be made largely without “permission” (e.g. finding out if their patient has had the examination before). So these really are just “tweaks.” They are small but at the same time well focused shifts toward values‐based radiography. Looking through them you can believe that participants in the workshop really would make the changes they suggest and that engagement with their patients would correspondingly be enhanced. Before turning to the conclusions to this chapter you may like to go back for a moment to your own tweak from Exercise 3 and ask yourself if it passes these two key tests of do‐ability: (i) the test of everyday practice (is your suggestion a tweak to your everyday routine practice?); (ii) the test of self‐sufficiency (can you implement your suggested tweak under your own steam and from your existing resources?)

Conclusions Using clinical vignettes and brief self‐test exercises this chapter has introduced and explored the contributions to patient engagement of a new approach to working with values in healthcare called values‐based practice. Part I looked at diversity of values and the challenge this presents for patient engagement. Part II introduced the skills and other elements of values‐based practice and explored some of the ways in which these support patient engagement. Part III applied the findings from Parts I and II to everyday practice by asking the reader to come up with a small but do‐able change – a tweak – that they could make in their own practice toward patient engagement based on values. The further reading given below sets out additional sources and resources for implementing values‐based clinical care. Values‐based patient engagement of the kind described in this chapter is about mutual engagement between clinician and patient. There are other models of patient engagement: a compliance model, often implicit, for example, when wasted prescriptions are being discussed; or a consumerist model in which engagement means simply giving the patient what they want (like a customer “the patient is always right!”). The story of Mrs. Jones’s knee in Part I illustrates the clinical importance of mutual engagement. Patient engagement in Mrs. Jones’s case was not a matter of her s­ urgeon,

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Mr. Patel, securing her compliance. Nor was it a case of Mr. Patel acceding to Mrs.  Jones’s wishes. It was a matter rather of a decision that was shared between them. Mr. Patel understood the risks and benefits of the evidence‐based options ­available. Mrs. Jones understood what those same risks and benefits meant from the perspective of her own values (of what was important to her). Mr. Patel thus engaged with Mrs. Jones’s values in deciding which option to recommend. But Mrs. Jones in turn engaged with what Mr. Patel had to offer by way of expert advice. The result of their mutual engagement was that Mrs. Jones said “yes” and meant it. This is what values‐based patient engagement is all about. It is about linking the science of medicine with the values of individual patients in a shared approach to clinical decision‐making.

Further Reading in Values‐based Practice The Collaborating Centre for Values‐based Practice at St. Catherine’s College in Oxford gives a wide variety of resources to support further development of values‐ based practice in your own area of clinical care (see valuesbasedpractice.org). The website includes in the section “More about VBP” a detailed Reading Guide and exemplar documents that can be downloaded in PDF form. For a series of clinical cases illustrating the role of values‐based practice in various areas of clinical care (breast surgery, diabetes management, etc.) please see: Fulford et al. (2012).

References Department of Health (2007). Mental Health Act 2007. London: Department of Health. Fulford, K.W.M., Dewey, S., and King, M. (2015a). Values‐based involuntary seclusion and treatment: value pluralism and the UK’s Mental Health Act 2007. In: The Oxford Handbook of Psychiatric Ethics (eds. J.Z. Sadler, W. van Staden and K.W.M. Fulford), 839–860. Oxford: Oxford University Press. Fulford, K.W.M., Duhig, L., Hankin, J. et  al. (2015b). Values‐based assessment in mental health: the 3 keys to a shared approach between service users and service providers. In: The Oxford Handbook of Psychiatric Ethics (eds. J.Z. Sadler, W. van Staden and K.W.M. Fulford), 1069–1090. Oxford: Oxford University Press. Fulford, K.W.M., Peile, E., and Carroll, H. (2012). Essential Values‐Based Practice: Clinical Stories Linking Science with People. Cambridge: Cambridge University Press. General Medical Council (2008). Consent: Patients and Doctors Making Decisions Together. London: General Medical Council. Handa, I.A., Fulford‐Smith, L., Barber, Z.E., et al. (2016). The importance of seeing things from someone else’s point of view. BMJ Careers on‐line journal: http://careers.bmj.com/ careers/advice/The_importance_of_seeing_things_from_someone_elses_point_of_view. Montgomery v Lanarkshire Health Board (judgment delivered March 11, 2015): https:// www.supremecourt.uk/cases/uksc‐2013‐0136.html. National Institute for Mental Health in England (NIMHE) and the Care Services Improvement Partnership (2008). 3 Keys to a Shared Approach in Mental Health Assessment. London: Department of Health. Von Wright, G.H. (1963). The Varieties of Goodness. London: Routledge & Kegan Paul.

4

Informed Consent and the Law From Patient Compliance to Patient Engagement? Richard Huxtable

Key Points • English law long supported a paternalistic approach to consent, in which “doctor knows best.” • Following a landmark 2015 ruling, English law now promotes a more patient‐ centered approach to (informed) consent, according to which doctors must consider the information needs of the reasonable patient and the particular patient. • The current approach to (informed) consent in English law appears capable of supporting the goal of patient engagement. • Time will tell how English law will develop in this area, although the patient‐ centered approach seems likely to endure.

Introduction English law has increasingly afforded room to patient choice. The need to respect patient autonomy (self‐rule or self‐determination) is emphasized throughout healthcare law in this jurisdiction: statutes are littered with references to the requirement for patient consent in relation to specific procedures1; patients who have capacity are entitled to refuse unwanted treatments, even if such treatment might be life‐sustaining2; and patients who lack capacity can choose to set down their wishes in advance,3 appoint a healthcare proxy,4 and – even in the absence of these – have their wishes and values  E.g. Human Tissue Act 2004.  E.g. Re B (Adult: Refusal of Medical Treatment) [2002] 2 All ER 449. 3  Mental Capacity Act 2005, ss. 24–26. 4  Mental Capacity Act 2005, ss. 9–14. 1 2

The Wiley Handbook of Healthcare Treatment Engagement: Theory, Research, and Clinical Practice, First Edition. Edited by Andrew Hadler, Stephen Sutton, and Lars Osterberg. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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inform any decision as to where their “best interests” lie.5 Failure to heed patients’ wishes might be considered an affront to their rights,6 and can result in censure by the criminal or civil courts, and perhaps professional discipline or loss of employment. Despite such efforts to promote and protect patient autonomy, there has long been an area of English law in which patient autonomy has been curiously underserved: the law of (informed) consent. The Center for Advancing Health has observed that: Engagement is not synonymous with compliance. Compliance means an individual obeys a directive from a health care provider. Engagement signifies that a person is involved in a process through which he harmonizes robust information and professional advice with his own needs, preferences and abilities in order to prevent, manage and cure disease.7

On this account, patient engagement requires a particular type of informed consent process, one in which the patient receives the information and advice necessary for him to decide, on the basis of his wishes and values.8 As we will see, following the 2015 ruling in the case of Montgomery,9 English law now appears to have reached a point in which the ideal of respect for patient autonomy and goal of patient engagement are better realized. It has, however, taken some time to get here. As such, in this chapter, we will trace the development of English law in relation to informed consent, before reflecting on how the law in this area might help or hinder patient engagement. In the next section, the sources and branches of English law are briefly introduced, in order to orientate the reader. The third section then outlines the law pertaining to informed consent as it long stood. Dominated by the decision in Sidaway,10 the law previously placed its emphasis on the professional and essentially promoted medical paternalism. As we see in the fourth section, the position gradually began to change in the 1990s, before patient autonomy then came clearly to the fore in Montgomery. In the fifth section, we reflect on these developments in the light of patient engagement. Montgomery is a recent ruling and it is likely that more will follow, in order to clarify some of the elements therein. However, the central thread – with its emphasis on patient autonomy – seems likely to endure for the time being. Whilst once the law of consent seemed to favor patient compliance, it nowadays appears that the law in this area is capable of supporting patient engagement.

An Introduction to Healthcare Law Medical law, or, more inclusively, healthcare law has been seen “as essentially concerned with the relationship between healthcare professionals (particularly doctors and to a lesser extent hospitals or other institutions) and patients.”11 Here, we focus on  Mental Capacity Act 2005, s. 4. See e.g. M v N [2015] EWCOP 76 (Fam).  E.g. Human Rights Act 1998, article 8 (right to respect for private and family life). 7  Center for Advancing Health. (2010). A New Definition of Patient Engagement: What Is Engagement and Why Is It Important? Retrieved 11 August 2016, from http://www.cfah.org/pdfs/CFAH_ Engagement_Behavior_Framework_current.pdf. 8  Save for when commenting on specific cases, I will refer to the claimant (patient) as male, the defendant (doctor) as female. 9  Montgomery v Lanarkshire Health Board [2015] UKSC 11. 10  Sidaway v Board of Governors of the Bethlem Royal Hospital and the Maudsley Hospital and Others [1985] 1 AC 871. 11  Kennedy, I. and Grubb, A. (2000). Medical Law: Text with Materials, 2e. London: Butterworths, 3. 5 6

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healthcare law in England and Wales (often referred to as English law); Scotland and Northern Ireland have their own legal systems.12 As a distinct branch of law, healthcare law (in this and other jurisdictions) really began to develop in the 1960s and 1970s.13 Of course, healthcare law did not appear from nowhere, fully formed, and its debts to the bigger branches of law from which it grew can sometimes be glimpsed. Two of the biggest branches of law are public law and private law. Public law essentially concerns an individual’s relationship with the State. A major branch of public law is the criminal law, through which the State forbids certain behavior, on pain of punishment. Private law, meanwhile, essentially governs relationships between individuals. It comprises such branches as contract law, in which two or more parties enter into a binding agreement on their own terms, family law, which governs such matters as marriage and the welfare of children, and tort law. Tort law can be difficult to define but might be seen as concerned with the protection of people’s interests: torts include defamation (my interest in my good character), trespass to land (my interest in maintaining the integrity of my territory), and, of more relevance to healthcare, trespass to the person (my interest in maintaining my bodily integrity) and negligence (my interest in being treated carefully or responsibly). Whether this or that behavior is contrary to this or that law depends not on the nature of the behavior: sometimes a single act (or omission) can be contrary to more than one law, as in the case of non‐consensual touching, which might be a criminal or a civil (non‐criminal) wrong.14 Each of these branches has its own legal terminology, procedures, and consequences. In both branches, the person alleged to have violated the particular law is known as the defendant. However, to extend our example, if the defendant is alleged to have committed a crime, such as assault, then the case will be prosecuted, and – if he is convicted – this will result in the punishment of the defendant (perhaps by imprisonment). Alternatively (or even additionally), if the defendant is alleged to have committed a civil wrong, such as the tort of trespass to the person, then the person complaining of the wrong – the claimant15 – will sue the defendant and, if successful, the defendant will be ordered to pay damages (i.e. provide financial compensation). The rules that make up all of these different branches of law can essentially be found in four types of sources. Legislation is the first source of law. Primary legislation comprises Acts of Parliament (known as statutes or simply Acts), which begin life as Bills, until they are passed by Parliament and gain legal force, on a specified date. There are numerous such Acts relevant to healthcare practice, whose titles indicate the nature of the rules within: for example, the Human Fertilisation and Embryology Act 1990, the Human Tissue Act 2004, and the Mental Capacity Act 2005. Secondary legislation – in the form of regulations or statutory instruments – can then provide rules that supplement related primary legislation. Of course, Acts (or even applicable provisions within relevant Acts) might be lacking for some situations, and there may also be occasions when an Act requires interpretation. The courts are there to undertake such interpretation and, on occasion, to 12  Welsh law is also increasingly developing in its own direction, including in relation to healthcare e.g. in adopting an “opt‐out” approach to organ donation: The Human Transplantation (Wales) Act 2013. 13  See e.g. In re Quinlan (1976) NJ 355 A 2d 647; Grubb, A. (1998). Glanville Williams: a personal appreciation. Medical Law Review 6 (2): 133–137. 14  The tort of trespass is discussed further below, in relation to information disclosure. 15  Known, in older cases, as the plaintiff.

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plug any gaps.16 The second source of law is, accordingly, the court rulings (or judgments) that make up the common law. As a common law system, English law observes a system of precedent. The doctrine of stare decisis (“to stand by the decision”) operates, which requires judges, when adjudicating on the case before them, to treat like cases alike and to look to previous court decisions, particularly those from superior courts. There are many courts in operation but, for healthcare law, the most pertinent, in ascending order of importance, are the High Court and Court of Protection, in each of which a single judge tends to sit, from whom appeals can be made to the Court of Appeal, where there tends to be a panel of three judges, from whom appeals can be made to the Supreme Court (formerly the House of Lords), wherein the panel comprises five or more of the most senior Law Lords and Ladies.17 The higher the level of the court, the more influential – indeed, binding – the ruling. Subsequent judges are required to heed any authoritative ratio decidendi (the reason for deciding the case, i.e. a statement of law applied to particular facts) and – depending on the authority of the court from which it was issued – may also need to heed any obiter dicta (that said in passing). The third source of law is European Union law. At the time of writing, the UK is a member state of the European Union, and is therefore bound, in various ways, by the rules it issues through its various organs. Although particularly concerned with trade between member states, European Union law has nonetheless had a bearing on healthcare practice: the Data Protection Act 1998, for example, originated in a European directive. This third source of law should not be confused with the fourth, which is the law arising from the European Convention of Human Rights.18 Not only has the UK ratified this Convention, it has also passed the Human Rights Act 1998, which essentially makes these rights directly enforceable in English courts. The Act, which applies to “public authorities,” has direct relevance to healthcare practice,19 and indeed some of the earliest cases brought under the Act concerned patients.20 It is an enduring question whether the law (including healthcare law) is ethically defensible. It is also not uncommon to hear people query why – or when – they have an obligation to obey the law. Of course, prudence alone gives a good reason for obedience, given the potential ramifications of disobedience. Yet, whether for ethical or prudential reasons, healthcare professionals need to heed more than the law – they need to observe the guidance issued by such august bodies as the Department of Health, Royal Colleges, General Medical Council (GMC), and the like. The precise status and force of such guidance varies. Failure to comply with guidance issued by one’s professional body, such as the GMC, could result in disciplinary action, which might end in the doctor being removed from the medical register. Such guidance might be considered “quasi‐legal” in nature. Sometimes, however, such quasi‐law can 16  The judges would insist they do not make law but (as healthcare law attests) they can be creative on occasion e.g. Re A (Children) (Conjoined Twins: Medical Treatment) [2000] 4 All ER 961; Re JS (Disposal of Body) [2016] EWHC 2859 (Fam). 17  If European law (outlined below) is relevant to the case at hand, appeals can also be made to the European courts. 18  See Wicks, E. (2007). Human Rights and Healthcare. Oxford: Hart Publishing. 19  Samanta, A. and Samanta, J. (2005). The Human Rights Act 1998: why should it matter for medical practice? Journal of the Royal Society of Medicine 98 (9): 404–410. 20  NHS Trust A v M; NHS Trust B v H [2001] 2 WLR 942; R (H) v MHRT North and East London Region [2001] EWCA Civ 415.

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become law, as, for example, when guidance from the GMC on confidentiality was cited with approval by a judge, who saw it as capturing the law.21 We will see another example of such alignment later.22 Generally, however, the guidance issued by bodies such as the GMC expresses professional, rather than legal, norms.

Before Montgomery: Professional Paternalism? The most famous expression of professional norms remains the Hippocratic corpus, which contains the following lament: Although the art of healing is the most noble of all the arts, yet, because of the ignorance both of its professors and of their rash critics, it has at this time fallen into the least repute of them all. The chief cause for this seems to me to be that it is the only science for which states have laid down no penalties for malpractice. Ill‐repute is the only punishment and this does little harm to the quacks who are compounded of nothing else.23

Today’s doctors might issue the opposite lament, as there are a plethora of penalties they must strive to avoid. Recent decades have seen an increase in the legal rules and professional guidelines within which doctors must navigate  –  not to mention the requirements of ethical review, evidence‐based medicine, and clinical governance. As we have begun to see, a single infraction can sometimes attract more than one form of censure, and the penalties for malpractice can vary greatly, from the rejection of a manuscript, to a finding of serious professional misconduct, a loss of employment, an order to pay financial compensation, all the way up to incarceration. Healthcare law has grown considerably since its first steps in the 1960s and 1970s. Viewed in its most flattering light, the law might appear to be the patient’s champion, given the range of penalties nowadays pointed at the medical profession. Doctors, of course, might take a dim view, fearing that the lawyers are correspondingly out to get them. To adopt a well‐worn legal phrase, the better view seems to lie somewhere between these two, as we will see in this analysis of the English law pertaining to informed consent to treatment. We will consider, in the next section, how far the law in this area has lately moved in the direction of protecting patients. Current legal developments nevertheless need to be placed in historical context – and recent legal history suggests that the law has been loath to surrender its ideal of the Hippocratic doctor. Aside from lamenting a lack of law, the Hippocratic corpus offered guidance for doctors, such as: Do everything in a calm and orderly manner, concealing most things from the patient while treating him. Give what encouragement is required cheerfully and calmly, diverting his attention from his own circumstances; on one occasion rebuke him harshly and  W v Egdell [1990] 2 WLR 471.  See the discussion of Montgomery in Section 5, below. Such alignment may be unsurprising, as law will inform the formulation of professional guidance: see e.g. General Medical Council. (2010). Treatment and Care Towards the End of Life: Good Practice in Decision Making. London: General Medical Council, 6. 23  Hippocrates. (1983). Hippocratic Writings (ed. Lloyd, G.E.R.; trans. Chadwick, J. and Mann, W.N.) New York: Penguin Books, 170. 21 22

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Here lies the Hippocratic doctor, seeking first to do no harm (primum non nocere), and second to work to the patient’s benefit. A concept like informed consent has no truck with this professional, in view of the distress – and accordingly harm – that disclosure might cause to the patient.25 In short, the Hippocratic doctor is a paternalistic doctor.26 English law has taken a long time to shake off this image (and, as we will see, may not entirely have done so).27 Certainly, the law has long had regard for the patient’s right to decide important matters for herself. English judges are wont to quote Cardozo J, a leading US judge, in a 1914 ruling: Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits an assault for which he is liable in damages.28

This remains the case in English law: failure to obtain “real” consent will render the doctor susceptible to a civil suit, for the tort of trespass to the person, and perhaps also to criminal prosecution, for crimes like assault or battery. Yet, such actions against healthcare professionals remain rare, particularly in the context of disclosure.29 This is unsurprising because the information threshold has been set low, as Bristow J explained in a ruling from 1980: once the patient is informed in broad terms of the nature of the procedure which is intended, and gives her consent, that consent is real, and the cause of action on which to base a claim for failure to go into the risks and implications is negligence, not trespass.30

As Harrington puts it, trespass – with its shades of criminal battery – “is seen as an inappropriately stigmatic label for doctors seeking in good faith to act in their patients’ interests.”31 The (civil) tort of negligence has therefore long been the battleground in the doctor–patient disclosure wars. Negligence has three essential components, each of which the claimant must prove, if she is to succeed and be awarded damages. Firstly, the claimant must prove that the defendant doctor owed her a duty, which, secondly, the doctor breached, by failing to provide care of a sufficient standard, which, thirdly, caused the patient to come to harm.  Longrigg, J. (1998). Greek Medicine: From the Heroic to the Hellenistic Age: A Source Book. New York: Routledge, 104. 25  Harrington, J.A. (1996). Privileging the medical norm: liberalism, self‐determination and refusal of treatment. Legal Studies 16 : 348–349, 367. 26  On paternalism, see: Childress, J.F. (2007). Paternalism in health care and health policy. In: Principles of Health Care Ethics, 2e (eds. R. Ashcroft et al.), (223–230). Chichester: Wiley. 27  See further section 5, below. 28  Schloendorff v Society of New York Hospital 105 N.E. 92 (N.Y. 1914), per Cardozo J. 29  A trespass suit might be brought if there is force, fraud, or undue influence e.g. Freeman v Home Office [1984] 1 All ER 1036. 30  Chatterton v Gerson [1981] 1 All ER 257. 31  Harrington, op. cit. n. 25, 352. 24

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Although it has its intricacies, the existence of a duty of care is often easiest to establish, at least in doctor–patient interactions: once the doctor has assumed responsibility for the patient, then he owes her a duty of care. As one old ruling has it, If a person holds himself out as possessing special skill and knowledge, by and on behalf of a patient, he owes a duty to the patient to use due caution in undertaking the treatment.32

What it means to exercise “due caution” pertains to the second element, the standard of care (or breach of duty). Here, the long‐established test was that articulated in Bolam, in 1957: The test is the standard of the ordinary skilled man exercising and professing to have that special skill … doctor is not guilty of negligence if he has acted in accordance with a practice accepted as proper by a responsible body of medical men skilled in that particular art.33

Presuming the patient has cleared these two hurdles, he then has to establish that the doctor’s breach of duty caused him harm. Causation has three elements: factual causation; legal causation; and remoteness of damage. At its simplest,34 factual causation amounts to “but for” causation: but for the doctor’s failure to provide care of a sufficient standard, the patient would not have been harmed.35 Legal causation looks to such matters as intervening causes, such that the law might hold that an intervening act has “broken” the chain of causation, so the defendant cannot be held liable.36 Finally, the harm complained of must not be “remote,” it must be reasonably foreseeable: in the words of one judge, “it must be shown that the injury suffered by the patient is within the risk from which it was the doctor’s duty to protect him.”37 It remains the case that the claimant‐patient must prove all three of these elements – duty, breach, and causation – if he is to succeed in his claim. However, the rules relating to each, and particularly the latter two, have evolved considerably, not least in the area of information disclosure. We will remain in legal history for now, and focused specifically on the second question as it pertains to disclosure: has the doctor failed to provide care of a sufficient standard, by failing to furnish the patient with sufficient information? Back in 1980, the British Medical Association (BMA) Handbook of Medical Ethics instructed that “The onus is always on the doctor carrying out the procedure to see that an adequate explanation is given.”38 It said little more than this,39 and the legally minded will be struck by the crucial word here: “adequate.” Shortly after (but unrelated to) this publication, the House of Lords had cause to consider what amounts to  R v Bateman (1925) 94 LJKB 791, 794.  Bolam v Friern Hospital Management Committee [1957] 1 WLR 582. 34  For further details, see Herring, J. (2016). Medical Law and Ethics, 6e. Oxford: Oxford University Press, 119ff. 35  For an example where factual causation was not established, see Barnett v Chelsea [1968] 1 All ER 1068. 36  For a controversial attempt to mount such an argument, see Emeh v Kensington and Chelsea Area Health Authority [1984] 3 All ER 1044. 37  Brown v Lewisham and North Southwark Health Authority [1999] Lloyd’s Rep Med 110 per Beldam LJ, 118. 38  British Medical Association. (1980). Handbook of Medical Ethics. London: British Medical Association, 13. 39  Contrast the 66 pages of guidance in General Medical Council. (2008). Consent: Patients and Doctors Making Decisions Together. London: General Medical Council. 32 33

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“adequate” information. Notably, the court’s decision was considered far from adequate by many commentators – and at least one of the judges therein.40 In Sidaway, the patient had undergone surgery to relieve pressure on her nerve roots.41 Although the responsible doctor had died by the time of the trial, the trial judge inferred that the doctor had warned the patient of a 2% risk to her nerve roots, but not of a 1–2% risk of damage to her spinal column. Mrs. Sidaway claimed that she would not have consented to undergo the procedure had she known of the latter risk. This risk had sadly materialized, leaving her seriously disabled. The House of Lords unanimously rejected her claim that the failure to warn had been negligent. Despite such agreement, the five Law Lords reached their common destination by different routes, thereby making the ratio of Sidaway rather difficult to discern. The judges all sought to answer a seemingly straightforward question: what information should the doctor volunteer to the patient? At one pole was Lord Diplock, whose answer was straightforward: “The Bolam test should be applied.”42 In other words, the doctor should disclose that which a responsible body of doctors in her position would disclose. At the opposite pole was Lord Scarman, who thought that disclosure should be directed toward that which “a reasonably prudent patient [would] think significant if in the situation of this patient.”43 He continued: The test of materiality is whether in the circumstances of the particular case the court is satisfied that a reasonable person in the patient’s position would be likely to attach significance to this risk.44

However, at that time at least, Lord Scarman was an outlier, because the remaining judges played variations on the Bolam theme. Lord Bridge (with whom Lord Keith agreed) stated that Bolam should apply, unless there was “a substantial risk of grave adverse consequences,”45 which should be disclosed by any “reasonably prudent medical man.”46 Lord Templeman also identified an exception, “that a doctor ought to draw the attention of a patient to a danger which may be special in kind or magnitude or special to the patient.”47 Exceptions may have been crafted and Lord Scarman may have dissented, but the majority of judges in Sidaway evidently favored a standard of disclosure that looked to prudent doctors, rather than prudent patients. To the dismay of commentators, this approach became more firmly entrenched over the following decade.48 In Gold, in 1987, the Court of Appeal confronted a failed sterilization, which had resulted in the patient giving birth to her fourth child.49 The patient alleged that her doctor had  E.g. Brazier, M. (1987). Patient autonomy and consent to treatment: the role of the law? Legal Studies 7 (3): 169–193; Teff, H. (1985). Consent to medical procedures: paternalism, self‐determination or therapeutic alliance? Law Quarterly Review 101: 432–453. 41  Sidaway v Board of Governors of the Bethlem Royal Hospital [1985] AC 871. 42  Sidaway, op. cit. n. 41, 895. 43  Sidaway, op. cit. n. 41, 888. 44  Sidaway, op. cit. n. 41, 889. 45  Sidaway, op. cit. n. 41, 900. 46  Sidaway, op. cit. n. 41, 900. 47  Sidaway, op. cit. n. 41, 903. 48  E.g. McLean, S.A.M. (1989). A Patient’s Right to Know: Information Disclosure, the Doctor and the Law. Aldershot: Dartmount Publishing Company. 49  Gold v Haringey Health Authority [1987] 2 All ER 888. 40

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failed to inform her of the risk of failure or of alternatives to sterilization (such as a vasectomy for her husband). The trial judge found for the patient and awarded her £19 000 in damages, on the basis that Sidaway was a distinguishable case, since that involved a therapeutic procedure, whereas the present procedure had been non‐therapeutic. The Court of Appeal disagreed: Sidaway applied, specifically the decision of Lord Diplock. Since a responsible body of doctors also would not have disclosed the risk and alternatives, the patient’s claim failed. Matters were to get worse for patients. The question of questions had arisen in Sidaway and Lords Diplock and Bridge had opined that, if the patient asked questions of their doctor, “the doctor would tell him whatever it was the patient wanted to know.”50 However, such (obiter) nuances were to be lost when the issue directly arose in court. In 1993, Blyth involved a patient, who happened to be a nurse, who asked about the side effects of the medication prescribed.51 Apparently few doctors would be expected to know the side effects, but this patient’s doctor did know – and yet did not disclose. At trial, the judge ruled that the patient was entitled to an answer; she was awarded £3500 in damages. The Court of Appeal took a different view. The case actually foundered on its facts, since the appellate court found that the question had not in fact been asked. The judges’ comments nevertheless reveal the reach of Bolam by this point. Kerr LJ opined that, following Sidaway, Bolam governed disclosure in situations where there was no inquiry from the patient. Maybe more remarkably, he added that, if the patient did make general inquiries, then Bolam still governed. He was more equivocal about those situations where the patient posed specific questions: here, it was perhaps the case that Bolam governed. Neill LJ, however, had no such reservations: even if specific questions were asked, the doctor was to be guided by Bolam. If only in the judges’ minds, the Hippocratic doctor – the paternalistic doctor – remained alive and well in the early 1990s.

After Montgomery: From Professional Paternalism to Patient Autonomy? In the late 1990s, the judicial tide began to turn, shifting power away from the prudent doctor and toward the prudent patient. The ultimate power nevertheless lay with the judges, as they signaled in 1997, in the landmark ruling in Bolitho.52 This negligence action did not concern informed consent directly, but it did reshape the legal landscape on which such actions are built. Here, the House of Lords sought to ­dispel any idea that careless doctors could evade liability simply by pointing to their – perhaps equally careless – peers. As Lord Browne‐Wilkinson put it, In the vast majority of cases the fact that distinguished experts in the field are of a particular opinion will demonstrate the reasonableness of that opinion. In particular, where there are questions of assessment of the relative risks and benefits of adopting a particular medical practice, a reasonable view necessarily presupposes that the relative risks and benefits have  Sidaway, op. cit. n. 41, per Lord Diplock, 895.  Blyth v Bloomsbury Health Authority [1993] 4 Med LR 151. 52  Bolitho v City and Hackney Health Authority [1998] AC 232. 50 51

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Speaking extra‐judicially around this time, Lord Woolf summarized the development: The over‐deferential approach is captured by the phrase: “Doctor knows best.” The contemporary approach is a more critical approach. It could be said to be that doctor knows best if he acts reasonably and logically and gets his facts right.54

This was not a new idea for the law,55 but its articulation in the Lords suggested times were changing. Commentators came to doubt whether the development had the impact that had been anticipated,56 but there were other changes afoot, which would further nudge the law in the direction of protecting patients’ rights. The Human Rights Act 1998, which brought the European Convention on Human Rights directly into English law, came into force in 2000. There were various rights that appeared capable of bolstering patients’ entitlements to disclosure, not the least was article 8, the right to respect for private and family life, which the European Court of Human Rights has associated with respect for autonomy.57 The seeds of autonomy began to take root in the law of negligence around this time. In 1998, the Court of Appeal had cause to revisit not only the threshold for disclosure, but also the vexed question of questions, in its decision in Pearce.58 The claimant, whose pregnancy was overdue, sought either an induced labor or cesarean section. The doctor warned her that inducing labor was risky in her circumstances, and that recovery from a cesarean section would be slower. The patient accepted these observations and opted for a natural birth. Unfortunately, her child was stillborn, a risk (of 0.1–0.2%) of which the patient had not been warned. The trial judge found for the doctor, as did the Court of Appeal, in view of the distress of the patient, the low risk, and the evidence which indicated that the patient would have opted for a natural birth even if warned of the risk of stillbirth. However, Woolf LJ, here in his judicial capacity, observed: if there is a significant risk which would affect the judgment of a reasonable patient, then in the normal course it is the responsibility of a doctor to inform the patient of that significant risk, if the information is needed so that the patient can determine for him or herself as to what course he or she should adopt.59

He suggested that a risk in the region of 10% would be one of which a patient should be warned.60 He also noted that “it is clear that if a patient asks a doctor about the risk, then the doctor is required to give an honest answer.”61  Bolitho, op. cit. n. 52, 243.  The Right Honourable the Lord Woolf. (2001). Are the courts excessively deferential to the medical profession? Medical Law Review 9 (1): 1–16, 1. 55  Hucks v Cole (1968) 112 Sol J 483. 56  Brazier, M., and Miola, J. (2000). Bye‐bye Bolam: a medical litigation revolution? Medical Law Review 8: 85–114. 57  No. 2346/02 Pretty v UK (2002) 35 EHRR 1, [61]. 58  Pearce v United Bristol Healthcare NHS Trust [1999] ECC 167. 59  Pearce, op. cit. n. 58, 174. 60  Pearce, op. cit. n. 58, 174. 61  Pearce, op. cit. n. 58, 169. 53 54

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These comments indicated that English judges were beginning to strike in the direction of their colleagues in Canada,62 Australia,63 and some of the United States,64 who favored a reasonable patient standard. Of course, by virtue of the rules of precedent, the Court of Appeal could not overturn the decision of the Lords in Sidaway. However, the Lords would soon have the opportunity to revisit the issues, in the 2005 case of Chester.65 Chester did not focus on the doctor’s standard of care but instead on the rules governing causation, as they relate to disclosure. Miss Chester saw Mr. Afshar, a neurosurgeon, regarding lower back pain. The doctor recommended surgery but (the trial judge found) did not inform the patient adequately of the risks, including a 1–2% risk of cauda equina syndrome (lower spinal cord nerve root disturbance). This risk materialized. The trial judge ruled that, although the doctor had performed the surgery to the appropriate standard, the lack of disclosure meant that he had breached his duty. Furthermore, the judge held that causation was also established: all the patient had to prove was that, had she been adequately advised, she would not have undergone the operation when she did. The Court of Appeal endorsed the trial judge’s findings of fact and agreed with his conclusions as to the law. The doctor appealed but the House of Lords ultimately also found for the claimant, albeit by a majority of three to two. The majority of the Law Lords reasoned that Miss Chester had been denied an opportunity, not of not having the surgery, but of having the surgery on another day, under different circumstances. Although he recognized he might be promoting “a narrow and modest departure from traditional causation principles,”66 Lord Steyn tried to cast this in terms of the usual “but for” test: but for the surgeon’s negligent failure to warn the claimant of the small risk of serious injury the actual injury would not have occurred when it did and the chance of it occurring on a subsequent occasion was very small.67

Commentators vary in their assessments, but it is difficult not to see the majority’s decision as subverting the “but for” test.68 Neither Lord Bingham nor Lord Hoffmann were impressed. According to Lord Bingham, Miss Chester has not established that but for the failure to warn she would not have undergone surgery. She has shown that but for the failure to warn she would not have consented to surgery on Monday 21 November 1994. But the timing of the operation is irrelevant to the injury she suffered, for which she claims to be compensated. That injury would have been as liable to occur whenever the surgery was performed and whoever performed it.69

 Reibl v Hughes [1980] 2 SCR 880.  Rogers v Whitaker (1992) 175 CLR 479. 64  Pape, T. (1997). Legal and ethical considerations of informed consent. AORN Journal 65: 1122–1127. 65  Chester v Afshar [2005] 1 AC 134. 66  Chester, op. cit. n. 65, [24]. 67  Chester, op. cit. n. 65, [19]. 68  E.g. Clark, T. and Nolan, D. (2014). A critique of Chester v Afshar. Oxford Journal of Legal Studies 34: 659–692. 69  Chester, op. cit. n. 65, [8]. 62 63

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Lord Hoffmann felt similarly: The purpose of a duty to warn someone against the risk involved in what he proposes to do, or allow to be done to him, is to give him the opportunity to avoid or reduce that risk. If he would have been unable or unwilling to take that opportunity and the risk eventuates, the failure to warn has not caused the damage. It would have happened anyway.70

Yet, these judges were in the minority, and the majority were evidently minded to do what they could to vindicate – in the words of Lord Steyn – the patient’s “right of autonomy and dignity.”71 Although it only reached a trial judge, rather than the appellate courts, the decision in Birch indicated that, by 2008, the judges were beginning to run with the theme of patient empowerment.72 The patient had suffered a stroke after undergoing a cerebral catheter angiogram. The doctor was found negligent for not having discussed with the patient different imaging methods (such as an MRI scan, as opposed to an angiogram) and their comparative risks and benefits. But despite this and the other apparent pro‐patient developments from Pearce onwards, Sidaway still lurked in the background of informed consent. Certainly the Lords had visited the territory since then, but Chester had concerned when a doctor’s (non‐)disclosure might cause harm, not what a doctor should be disclosing. On the latter issue, Sidaway still remained the most authoritative judicial pronouncement. Three decades on from Sidaway, the senior judges seized their opportunity to revisit the duty to disclose, in the 2015 ruling in Montgomery.73 By this point the House of Lords was no more, having reconvened as the Supreme Court. Professional guidance had also moved on considerably from the time of Sidaway. By now, the GMC instructed doctors that they “should” work in partnership with their patients,74 and – note the imperative – “must give patients the information they want or need,”75 and “must answer patients’ questions honestly and, as far as practical, answer as fully as they wish.”76 The decision in Montgomery then ensured that these imperatives made the leap from quasi‐legal professional norms to legal principles. Mrs. Montgomery’s claim before the Supreme Court related to her ante‐natal care.77 She complained that she should have been informed about the risk of shoulder dystocia, which was present should she deliver vaginally, and of the alternative means of delivery by cesarean section. Since the patient suffered from diabetes and was of low stature, her risk of shoulder dystocia materializing was 9–10%. Having not been so informed and therefore unaware of the respective benefits and risks of the two options, the patient proceeded to deliver naturally. Unfortunately, the risk of shoulder dystocia materialized, which resulted in her son being born severely disabled. The patient claimed that, had she been informed, she would have opted for a cesarean section.  Chester, op. cit. n. 65, [28].  Chester, op. cit. n. 65, [24]. 72  Birch v University College Hospitals NHS Trust [2008] EWHC 2237. 73  Montgomery, op. cit. n. 9. 74  General Medical Council, op. cit. n. 39, [3]. 75  General Medical Council, op. cit. n. 39, [9]. 76  General Medical Council, op. cit. n. 39, [12]. 77  An additional claim was also pursued in the lower courts (and note that the case originated in Scotland, although the ruling has effect in English law). 70 71

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The Supreme Court unanimously found for the patient, and she and her son were awarded £5.25 million in damages.78 The risk of shoulder dystocia should have been explained to Mrs. Montgomery, as should the option of a cesarean section. Lords Kerr and Reid (jointly delivering the court’s decision79) articulated the essence of the ruling as follows: An adult person of sound mind is entitled to decide which, if any, of the available forms of treatment to undergo, and her consent must be obtained before treatment interfering with her bodily integrity is undertaken. The doctor is therefore under a duty to take reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments.80

Their Lordships then spelled out what constituted a “material risk”: The test of materiality is whether, in the circumstances of the particular case, a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.81

Risk is not to be determined by reference to percentages, as a range of factors will determine its materiality, specifically the particular facts of the case and any characteristics of the individual patient.82 Furthermore, disclosure must be clear and comprehensible to the individual patient: the doctor should strive to avoid, at one extreme, merely obtaining a signature on a consent form, or, at the other, overloading the patient with potentially incomprehensible technical information.83 The court did, however, recognize three exceptions to the duty to disclose risks. Firstly, the doctor may refrain from disclosing, where the patient has made it clear that she would prefer not to discuss the matter.84 Secondly, the doctor may refrain from disclosing “in circumstances of necessity, as for example where the patient requires treatment urgently but is unconscious or otherwise unable to make a decision.”85 Finally, and perhaps most significantly, the doctor may refrain from a disclosure “as to a risk if he reasonably considers that its disclosure would be seriously detrimental to the patient’s health.”86 However, their Lordships emphasized that this “therapeutic exception” is to be a limited exception, which does not enable the doctor to prevent the patient from making an informed choice where she is liable to make a choice that the doctor considers to be contrary to her best interests.87   BBC News. (2015). Nadine Montgomery wins £5 m from NHS Lanarkshire over brain damage to her son. 11 Mar. 2015. Retrieved 30 November 2016, from http://www.bbc.com/news/uk‐scotland‐ glasgowwest‐31831591. 79   Lady Hale’s judgment further commented on consent and childbirth. 80   Montgomery, op. cit. n. 9, [87]. 81   Montgomery, op. cit. n. 9, [87]. 82   Montgomery, op. cit. n. 9, [89]. 83   Montgomery, op. cit. n. 9, [90]. 84   Montgomery, op. cit. n. 9, [85]. 85   Montgomery, op. cit.  n. 9,  [88]. The judges did not elaborate on this, as the matter was not directly before them. 86   Montgomery, op. cit. n. 9, [88]. 87  Montgomery, op. cit. n. 9, [91]. 78

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Leaving aside these caveats, the judges appear to have come a long way. In legal terms, the message now seems to be that it might no longer be the doctor, but rather the patient, who knows best.

Discussion: From Patient Compliance to Patient Engagement? The legal approach to disclosure that dominated in the early 1990s was evidently antithetical to patient engagement. Blanton, a volunteer patient adviser in the US writing in 2015, could easily have been writing about the consultation as depicted in English law at the time of Sidaway: Imagine waiting in a clinic exam room for your provider. The provider enters the room with the health care team. They greet you and pass a printout amongst themselves. Your provider turns and examines you. He quickly turns to the team and discusses his findings in a language that is foreign to you. The team discusses you and a care plan “for” you, and then they exit the room.88

In terms of disclosure, the patient was to sit passively in the consultation room, being provided with information that her doctor – looking to his colleagues – felt it proper to impart. If she had the temerity to raise general inquiries or, more audaciously, specific questions, then these would be answered, but apparently only if a responsible body of doctors would disclose such information in such a situation. Presumably, if his peers felt it should be so, a doctor could have sat mute as his no‐ doubt bewildered patient made her enquiries. Rather than patient engagement, this sounds more like patient compliance, along the lines earlier noted by the Center for Advancing Health.89 This legal position, championed by the majority of judges in Sidaway, appears to have been swept away with Montgomery. Montgomery effectively reverses the majority’s reasoning in Sidaway and in so doing broadly instates the position Lord Scarman had promoted at that time: whereas disclosure was previously to be led by the professional unless there were risks or “special” considerations that had to be disclosed, now disclosure is to be led by the patient unless there are risks or special considerations that should disincline the professional to disclosure. As such, the ruling appears to swing the pendulum from the professional and toward the patient. A similar swing had already occurred in other jurisdictions, such as Australia,90 and has since occurred elsewhere, notably in a recent ruling from the highest court in Singapore.91 But patient engagement does not strictly seek or require this swing: as Blanton notes, the approach is designed to include “patients and their families in authentic partnerships from the patient’s room to the boardroom.”92 So does the approach in Montgomery support patient engagement in such a sense?

88  Blanton, K. (2015). The patient engagement prescription. North Carolina Medical Journal 76 (3): 157– 160 (emphasis in original). 89  Center for Advancing Health, op. cit. n. 7. 90  Rogers, op. cit. n. 63. 91  Hii Chii Kok v Ooi Peng Jing London Lucien & NCCs [2017] SGCA 38. 92  Blanton, op. cit. n. 88, 157.

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Certainly, many appear to take from the ruling the idea that patients now know best. Legal commentators have dubbed this “one of the most eagerly awaited and arguably long overdue judgments of recent times,”93 and have welcomed its adoption of “a patient‐centered test for disclosing risk and obtaining consent in medical treatment.”94 The ruling notably strives not only to accommodate the (objective) reasonable patient, who had been envisaged by Lords Scarman and Woolf, but also the (subjective) particular patient. This latter emphasis on the subjectivity of the particular patient might raise alarm among some professionals, who could feel that they are now required to second‐guess a patient’s preferences or otherwise to expend considerable efforts getting to know that patient’s preferences (within undoubtedly time‐ constrained consultations).95 But in terms of patient engagement, this emphasis does at least require the professional to communicate with the patient they have before them, rather than some abstract notion of a patient. Yet, it is arguable that the ruling does not wholly signal that the patient knows best. There are various indications that the doctor can also provide their input and draw on their expertise in the consultation. This is most obvious in the exceptions noted in Montgomery: doctors will be required to judge, for example, when disclosure might expose the patient to significant harm and they may, in exceptional situations, decline to disclose on this therapeutic basis. And there are other aspects of the ruling which signal that the skills and judgments of doctors are to be accommodated. Note, first, that this ruling essentially brings the law into line with guidance already issued by the General Medical Council – guidance which was formulated by and for the medical profession.96 Second, there are various references to the need for the doctor to take “reasonable care,” which would appear to require him to draw on his medical expertise and (as before) look to his peers. How else is the doctor to ensure that he has taken “reasonable care” to inform a patient, has identified and discussed “reasonable alternatives” to the proposed treatment, is “reasonably aware” of a particular patient’s inclinations or (to return to the aforementioned exception) “reasonably” considers that disclosure would be harmful to the patient? Presumably, in order to meet these obligations, the doctor must look to that which other responsible doctors would do. For example, the doctor might draw on expert guidance designed to help inform the reasonable patient, such as research that indicates the “core information” which should be imparted to patients undergoing particular procedures.97 Then, having considered the objective patient, the doctor might draw on specialist consultation skills developed and adopted by their peers, in order to engage the subjective patient, i.e. the actual patient before him.98 93  Heywood, R. (2015). R.I.P. Sidaway: patient oriented disclosure: a standard worth waiting for? Medical Law Review 23 (3): 455–466. 94  Farrell, A.M. and Brazier, M. (2016). Not so new directions in the law of consent? Examining Montgomery v Lanarkshire Health Board. Journal of Medical Ethics 42: 85–88. 95  The court acknowledged, but dismissed, this concern: Montgomery, op. cit. n. 9, [92]. 96  Albeit, of course, with relevant external input via the consultations usually undertaken on such guidance. Query, however, whether such professional guidance manages, in practice, to influence doctors’ behaviour: cf. Baiardini, I., Braido, F., Bonini, M. et al. (2009). Why do doctors and patients not follow guidelines? Current Opinion in Allergy & Clinical Immunology 9 (3): 228–233. 97  E.g. Blazeby, J.M. et al. (2015). Core information set for oesophageal cancer surgery. British Journal of Surgery 102 (8): 936–943. 98  E.g. Fong Ha, J. and Longnecker, N. (2010). Doctor–patient communication: a review. Ochsner Journal 10 (3): 38–43.

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There may, therefore, be a case for saying that the ruling does promote a partnership and, perhaps, strikes in the direction of shared decision‐making. Notice that the court explicitly refers to the need to engage in discussion: It is … necessary to impose legal obligations, so that even those doctors who have less skill or inclination for communication, or who are more hurried, are obliged to pause and engage in the discussion which the law requires.99

Whilst “engage” occurs only in this passage, the term “discuss” recurs throughout the ruling. Discussion, of course, implies a two‐way process. The doctor must know what to impart to the reasonable patient and be equipped to engage the particular patient, who in turn will be sufficiently involved and informed to decide whether or not he wishes to undergo the procedure in question (or, indeed, some alternative). Maybe, then, the ruling indicates that professional plus patient know best. There is, however, a fourth reading available: judges know best. Montgomery might be read as a continuation of the theme first played in Bolitho: as Farrell and Brazier put it, the ruling “emphasised that the courts bear responsibility for determining the nature and extent of patients’ rights, not the medical profession.”100 And there are numerous loose threads left hanging in this ruling, for future courts to pull at or snip away as they judge best. What is to count as a “reasonable alternative”?101 Might the ruling open the floodgates to numerous claims from patients?102 If so, might the English judges follow their Australian brethren and sistren in drawing stricter lines around causation, in order to limit such claims?103 When might the therapeutic exception properly apply?104 When can a patient delegate a decision if he prefers not to know?105 And where is the line to be drawn between a matter that is “determined by medical learning or experience” (which is apparently objective) and an “exercise of medical judgement” (which is apparently subjective)?106 Some future litigation is therefore to be expected, in order to clarify elements of the decision in Montgomery. Nevertheless, in its primary emphasis on the need to focus on the patient, and in apparently also affording some room to professional judgment, the ruling does appear to encourage patient engagement in the consent process.

Conclusion The English law governing informed consent to medical treatment has changed significantly. The 1985 decision in Sidaway from the (then) highest court, the House of Lords, largely led the way, until the 2015 decision in Montgomery from the (now)  Montgomery, op. cit. n. 9, [93].  Farrell and Brazier, op. cit. n. 94. 101  Heywood, op. cit. n. 93. 102  Query what sorts of claims might come. For discussion of an interesting recent case, see: Sokol, D. (2016). Who will operate on you? British Medical Journal 355: i5447, doi: https://doi.org/10.1136/ bmj.i5447. 103  Farrell and Brazier, op. cit. n. 94. 104  Farrell and Brazier, op. cit. n. 94. 105  Farrell and Brazier, op. cit. n. 94. 106  Montgomery, J. and Montgomery, E. (2016). Montgomery on informed consent: an inexpert decision? Journal of Medical Ethics 42: 89–94. 99

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highest court, the Supreme Court. Taking a cue from Hippocrates, the majority of judges in Sidaway had placed their emphasis on the professional and encouraged a paternalistic approach, which seemed to favor patient compliance, rather than patient engagement. Montgomery effectively reversed the approach and appears to emphasize the role of the patient and their autonomous wishes. However, the judges’ repeated references to the need for discussion might signal that neither patient nor professional know best, but rather that the two  –  working in partnership  –  might together know best. Read in this way, the ruling seems to promote the idea of patient engagement. That said, there are also indications in the ruling that ultimately it is judges who know best. Time will tell how the law in this area will develop. It nevertheless seems unlikely that the courts will be minded to unpick the central threads of Montgomery. As such, in relation to consent, English law currently seems amenable to Blanton’s plea “that patient engagement must be a part of all health care‐related prescriptions.”107

Acknowledgments Thanks to Louise Austin for her helpful comments on the previous draft of this chapter.

 Blanton, op cit. n. 88, 159.

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Assessing, Measuring, and Monitoring Treatment Engagement Donald E. Morisky and Chia‐Hsin Emily Cheng

Key Points • Early and accurate identification of behavioral and cognitive indicators of adherence helps coordinate patient treatment plans. • Objective methods of measuring adherence mostly rely on pharmacy data, pill counts, prescription refills, electronic monitoring devices, and biomarker tests. • Subjective measures of adherence include patient interviews, scales and ­questionnaires, and adherence journals that rely on patients, family members, or caretakers. • Employing both objective and subjective measures of adherence yields the most accurate information about the degree and reasons for non‐adherence.

Introduction Adherence to treatment regimens is the cornerstone of effective management of long‐term infections and chronic health conditions. It is generally defined as the congruence between patients’ activities and their prescribed healthcare recommendations (Iuga and McGuire 2014; WHO 2003). According to the criterion defined by Gordis (1976), adherence is “the point below which the desired preventive or desired ­therapeutic result is unlikely to be achieved” (p. 52). And in prescribing medication, adherence usually refers to the extent to which patients take the medication as ­prescribed. These broad conceptual definitions assume that there is a known threshold of desired effect and are vague in what constitutes non‐adherence for a given treatment regimen.

The Wiley Handbook of Healthcare Treatment Engagement: Theory, Research, and Clinical Practice, First Edition. Edited by Andrew Hadler, Stephen Sutton, and Lars Osterberg. © 2020 John Wiley & Sons Ltd. Published 2020 by John Wiley & Sons Ltd.

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As a major behavioral determinant, patients who are non‐adherent to medications have lower effectiveness of drug therapy and poorer clinical outcomes such as number of hospitalizations, number of days in hospital, as well as higher mortality rates when compared to patients with high adherence rates (Kim and Evangelista 2010; Nieuwlaat et al. 2014; Simpson et al. 2006). Moreover, the cost of managing the aftermath of low adherence was estimated to be more than 100 billion US dollars annually as of 2008 (Viswanathan et al. 2012), a figure that has continued to increase with up to 30% of overall healthcare cost attributed to non‐adherence (Iuga and McGuire 2014), making improving patient adherence a public health priority. Patient self‐management entails a multitude of behaviors, including correct consumption of medications, following prescribed treatment regimens, and making appropriate lifestyle changes such as diet and physical activity (Meichenbaum and Turk 1987). For example, end‐stage renal disease patients typically require hemodialysis treatments three times a week for three to four hours each session (Chilcot et al. 2010). In addition, patients are often prescribed multiple medications which can range from a low of 6 to a median of 19 to a high of more than 25 tablets a day to manage blood pressure, anemia, metabolic diseases, and other chronic conditions (Burnier et al. 2014). Adding to the complex regimen are often restrictions of certain foods and reduced intake of salt and fluids. Hence, adherence presents a challenge for both patients and clinical staff members (Kim and Evangelista 2010). In this chapter, we review the evidence for various methods of assessing treatment adherence and engagement in a field where patient self‐reports and practitioners’ impressions are viewed as highly unreliable. We focus on medication‐taking behavior as drug therapy is ubiquitous across most chronic and acute health conditions in traditional Western medicine.

Why Is Measuring Adherence Important? Many chronic disease patients have a heavy daily pill burden. The large number of daily medications a patient must take is a major determinant of long‐term adherence to treatment regimens (Chiu et  al. 2009). In order to facilitate patient treatment engagement, accurate and timely assessment of medication‐taking behavior is crucial. Thus, early and accurate identification of behavioral and cognitive indicators of adherence will help providers and researchers better tailor and streamline the coordination of treatment plans, increase patient awareness and promote patient self‐management, and thus improve clinical outcomes and patient quality of life. Complicating the plethora of treatment regimens in the many chronic conditions that patients have is the variability in the rate of non‐adherence and how this non‐ adherence is measured (Hecking et al. 2004; Naderi et al. 2012). For example, data from pharmacy refills show adherence of 30–80% among heart disease patients (Naderi et  al. 2012) and 0–80% among dialysis patients (Molnar et  al. 2016). Moreover, patients with chronic conditions typically have lower adherence rates than do patients with acute conditions. A major challenge in interpreting and comparing findings across studies is the lack of standardized measurement of adherence and varying operational definitions of adherence both within and across health conditions ­ (Lam and Fresco 2015).

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How Is Medication Adherence Measured? In order to quantify medication adherence, several methods of measuring adherence have been developed for use in both clinical and research settings. These include ­objective methods that mostly rely on pharmacy data and clinical outcomes such as pill counts, prescription refills, electronic monitoring devices, and biomarker tests. In addition, subjective methods, including patient interviews, scales, and questionnaires, and adherence journals that rely on data provided by patients, their family, or their caretakers, are also widely used. We describe some of the commonly used methods that attempt to measure adherence and highlight their strengths and weaknesses.

Direct methods Biochemical analysis of a drug or its metabolite concentrations is considered the most objective and direct method of assessing adherence. This is done by quantifying the amount of medication or its metabolite in the saliva, blood, or urine. Drug detection from patient’s urine is relatively convenient and popular because most drugs or their metabolites are excreted into urine (Blackwell 1976). Sometimes a detectable biomarker is added to a drug formulation that can be measured in the blood. Objective methods with biochemical indicators may be considered more accurate; however, these methods can lack specificity and/or sensitivity as they can give false positive results or no result depending on the variability of absorption, distribution, metabolism, and excretion of the drug (Gordis 1979; Lam and Fresco 2015; Lee et al. 2007; Osterberg and Blaschke 2005). Another factor that hinders direct quantification is drug–food and drug–drug interactions, causing inaccuracy of the biomarker measurement and further complicating the definition of non‐adherence (Lam and Fresco 2015). Moreover, biochemical tests may not be suitable for patients who are on multidrug treatments or psychiatric medications. There is also the potential bias of improved adherence around the time of clinic visits, improving to an average of 88% before a visit and 86% after the visit, but declining to about 67% one month later (Modi et al. 2012). This phenomenon, known as “white coat adherence,” results in patients giving the impression of improved medication adherence near the time of appointments when drug testing takes place (Modi et al. 2012). Direct measures such as biomarkers are intrusive and expensive and should not be considered a “gold standard” for measuring adherence, and they typically do not provide any information on the cause or pattern of non‐adherence (Lam and Fresco 2015). Other objective measures with an indirect approach to assess adherence are pill counts and secondary analysis of electronic prescriptions or pharmacy insurance claims databases using calculations such as the medication possession ratio (MPR). Both measures are relatively easy and straightforward to collect, however, a major problem with both is typically an overestimation of adherence, as described below.

Indirect methods Refill measures  In this method a comparison between data obtained from a pharmacy system (primary data) and data obtained from a refill pattern (secondary data) is done (Stirratt et al. 2015). A continuous variable measure uses the MPR to assess

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“from first to last prescription record.” Dichotomous variable is the form of assessment in which the patient is categorized into two ranks: one in which the patient is compliant (adherent) or non‐compliant (non‐adherent). The classification is based on the observation of the interval between refills considering the time of adherence and non‐adherence. The refill method is at best a proxy measure of a patient’s persistence to the medication regimen as it does not provide any data on whether or not the patient is taking the proper doses at the assigned times (Stirratt et al. 2015). Pill counts  Pill counts involve enumeration of remaining pills in the prescription bottles to check how many pills have been used and how many are left. The main flaw in this method is the assumption that missing pills have actually been consumed by the patient; for example, patients may throw pills out before coming to their appointment (Lehmann et al. 2014; Rudd et al. 1988). This method also relies on the accurate reporting of the dates and quantity (Lee et al. 2007). Underestimation of adherence is a possible shortcoming of using pill counts since this method involves counting the remaining pills in the bottle and noting whether the patient had refilled the medication before taking all the pills completely (Stirratt et  al. 2015). Despite these limitations, a comparison study of both clinical trials and clinical practice showed that pill count was a more superior method than 24‐hour recall or refill history when analyzing adherence to medication for cardiovascular diseases (Lee et al. 2007). Electronic devices  Another innovation in research on adherence is the use of ­electronic packaging devices known as Electronic Medication Packaging (EMP) or Medication Events Monitoring System (MEMS). The device is planted in the packaging of medicine and whenever the patient takes out doses it logs the time and date. This measurement is based on the assumption that the patient is taking out and ­consuming the prescribed amount of dose (Liu et al. 2015). The electronic devices can be used for recording of medication time and date, direct monitoring of adherence through the internet, and they can also be used as an intervention method to remind the patient of the next dose. These devices are easy to use by the patient and provider because of their digital displays (Checchi et  al. 2014). Some psychiatric and schizophrenic patients have shown signs of anxiety due to the thought that they are being watched by the electronic package (Farmer 1999). These devices are useful for measurement of partial adherence, but due to high production and maintenance costs they are not widely adopted. However, advances in digital technology and lower costs may contribute to their increased use in the near future. Adherence apps  With advancements in cellular technology and emergence of smartphones, medication adherence apps have been developed to provide patients and providers with an easy alternative to keep track and monitor real‐time medication‐taking behavior (Dayer et al. 2013). With smartphone usage increasing globally each year, inexpensive adherence apps can help contribute to increased adherence rates (Meeker 2014). A study of 160 apps shows the potential of increasing medication adherence and using them as a systematic intervention for chronic patients (Dayer et al. 2013). However, few studies have tested the efficacy of the apps and further research is needed to assess the reliability and validity of the apps in improving adherence and predicting clinical outcomes.

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Self‐reporting methods The most common adherence methods in clinical practice for adherence assessment are based on patient self‐report, including clinical interviews, questionnaires, and adherence journals. Self‐reports are popular because of their ease of use and low cost. However, these approaches also have issues with overestimation of adherence and recall bias, and depend considerably on the expertise and efficiency of the interviewer and the content of questionnaires (Stirratt et al. 2015). For example, if a patient is forgetful about their medication regimen, he or she may not recall if they have unintentionally skipped a dose, making this method impractical for patients who have memory problems (Claxton et al. 2001).

Interviews Interviews are generally conducted by trained clinicians asking the patient questions about their medication regimen, including self‐perception of adherence and knowledge about the drug (Farmer 1999). Motivational interviews that combine the assessment and intervention in one session are common among psychiatric patients. In this approach a patient with low adherence is briefed about the consequences of non‐adherence and is encouraged to take their medication on prescribed time and amount. Despite its popularity, usability, and inexpensiveness, its limitation is lower reliability and concordance between patient responses and actual behavior (Lam and Fresco 2015). Blackwell (1976) reported that 36–50% patients lie or overestimate adherence when validated with counter testing by refill‐assessment method, pill count, or urine testing. Adherence journals  Adherence journals are diaries kept by patients to log medication events like timing, dose, and date. Patients usually keep the diary with them during a specific time, and then the diary is submitted to the relevant person for evaluation. Again, as journaling is self‐reported, this method is subject to recall bias, with patients either unintentionally or intentionally overestimating adherence. Comparative studies between self‐reporting through adherence journals and MEMS indicate an overestimation of 30% by self‐reporting method (Straka et  al. 1997). Underestimation of adherence can also result if a patient takes the medicine but fails to log it in the diary. Other problems with adherence journals include the inability to return the diary or patients refusing to return them.

Questionnaires and scales Evaluation of adherence, compliance, and persistence to medication‐taking behavior is mostly done through questionnaires and scales. These assessments are relatively inexpensive, easy to administer, reliable, and validated (Culig and Leppée 2014). Following are some of the more popular scales and questionnaires for adherence measurement. Brief medication questionnaire (BMQ)  The BMQ assesses both medication‐taking behavior and barriers to adherence (Svarstad et  al. 1999). It comprises three ­sections: (i) regimen screen assesses how patients took their medications in the past week  (five  items); (ii) belief screen evaluates drug efficacy (two items); and (iii) recall  screen  taps into remembering difficulties (two items). This method allows

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self‐administration, analyzes multi‐drug prescriptions, and requires minimal practitioner training. The disadvantage of this questionnaire is the time‐consuming review of patient’s medical regimen before evaluation. The Hill‐Bone compliance scale  The Hill‐Bone is primarily designed for anti‐hypertensive medications and thus limited in its generalizability. Studies have shown that this scale is more accurate and popular for the measurement of hypertensive black patients (Lavsa et al. 2011). This questionnaire is also divided into sections that assess sodium intake, medication‐taking behavior, and potential for keeping an appointment. The scale has shown moderate concurrent and construct validity. The medication adherence rating scale (MARS)  The MARS is a 10‐item scale that assesses medication‐taking behavior barriers and beliefs. It is based on the Drug Attitude inventory (DAI). The DAI is widely used in psychiatric studies but has low reliability and accuracy, so MARS addresses those deficiencies by incorporating questions from Morisky, Green, and Levine’s Medication Adherence Questionnaire (MAQ). The MARS has moderate reliability and validity but a lower internal consistency of 0.60 alpha (Thompson et al. 2000). Adherence to refills and medications scale (ARMS)  The 12‐item ARMS was originally developed for coronary heart disease patients (Kripalani et  al. 2009). It has adequate reliability and validity when validated with the Morisky Medication ­ Adherence Scales (MMAS‐8), and it has also proved useful for patients with low literacy. The ARMS correlates with both refill adherence and Morisky adherence scales. Low ARMS values show high adherence and patients with low ARMS values have a better treatment efficacy (Culig and Leppée 2014). Medication adherence questionnaire (MAQ)  This adherence measure was developed by a team of researchers at the Johns Hopkins University Medical Institution in the early 1970s. Several articles addressing the adherence measure were published on the two‐year results (Green et al. 1979; Levine et al. 1979, 1987; Morisky et al. 1980, 1983). This study cohort was followed for an additional three years to assess the long‐term results of medication‐taking behavior, morbidity, and mortality (Morisky et al. 1983, 1986). The five‐year analysis identified a continuing positive effect on ­appointment keeping, weight control, and blood pressure control. All‐cause life table mortality rate was 57.3% less for the experimental group compared to the control group (12.9/100 vs 30.2/100, p