2nd Edition
Complex Interventions in Health An Overview of Research Methods
Foreword A Brief History of The Development of the 2021 Updated Mrc Framework Guidance Document
Laurence Moore
1. An Introduction to Researching Complex Interventions in Health
David Richards
2. The Theory and Practice of Patient and Public Involvement for Complex Interventions
Beccy Summers, Sharon Cooper and Kristen Liabo
3. The Experience of Patient and Public Involvement for Complex Interventions
Louise Ting and Adele Webb
Section I
Introduction To Section I Developing or Identifying Complex Interventions
Gabriele Meyer and Sascha Köpke
4. How to Develop Complex Interventions
Alicia O’caithan
5. Reviewing and Synthesising Quantitative Data on Complex Interventions
Ralph Möhler And Julian Hirt
6. Reviewing and Synthesising Qualitative Data on Complex Interventions and Integrating in Mixed Methods Syntheses
Katy Sutcliffe And Jane Noyes
7. Understanding the Contextual Situation for The New Complex Intervention
Lisa Pfadenhauer, Ani Movsisyan and Eva Rehfuess
8. Identifying Uncertainties and Questions When Developing Complex Interventions
Nienke Bleijenberg and Janneke De Man-Van Ginkel
9. The Use of Programme Theory in Intervention Development
Knud Ryom, Anna Mygind and Helle Terkildsen Maindal
10. Complex Interventions: A Behaviour Change Perspective
Molly Byrne, Marta Marques, and Angela Fidler Pfammatter
11. Modelling Process and Outcomes in Complex Interventions
Mieke Deschodt and Walter Sermeus
Section II
Introduction To Section II Investigating the Feasibility of Complex Interventions
David Richards and Jo Woodford
12. Feasibility and Pilot Studies for Complex Interventions: An Introduction
Lora Giangregorio And Gillian Lancaster and Lahana Thabane
13. Addressing Uncertainties Related to Interventions Using Qualitative and Quantitative Methods
Nancy Feely and Sylvie Cossette
14. Using Feasibility Studies to Address Methodological and Procedural Uncertainties Prior To Clinical Trials
Ella Thiblin And Jo Woodford
15. How to Calculate the Sample Size Required for Definitive Randomised Controlled Trials
Obioha Ukoumunne, Saskia Eddy and Fiona C Warren
16. Identification and Quantification of Progression Criteria in the Design, Conduct and Reporting of Feasibility Studies
Katie Mellor And Sally Hopewell
17. Feasibility in Practice; Undertaking A Feasibility Study to Answer Procedural, Methodological and Clinical Questions Prior To a Full Scale Trial
Holly Sugg
18. Evaluability Assessments
Nai Rui Chng
Section III
Introduction To Section III Evaluating Complex Interventions
Yvonne Wengström and Ingalill Rahm Hallberg
19. Evaluating Efficacy and Effectiveness in The Context of Complex Interventions: Clinical Trial Designs, Benefits, And Shortcomings
Siobhan Creanor
20. Process Evaluation of Complex Interventions: Evolving Perspectives
Elizabeth McGill and Graham Moore
21. Economic Evaluations of Complex Interventions
Alexander J Thompson and Katherine Payne
22. Additional Resources for Evaluating Complex Interventions
Ingalill Rahm Hallberg
23. Evaluating Population-Level Health Interventions
Graham Moore
24. Theory-Based Evaluation of Complex Health Interventions
Brad Astbury
25. Simulation Modelling to Evaluate Complex Interventions
Daniel Kopasker and Srinivasa Vittal Katikireddi
Section IV
Introduction To Section IV Implementing Complex Interventions
Carole Estabrooks And Lars Wallin
26. The Implementation Phase: Using Implementation Science Theories, Models and Frameworks
Per Nilsen
27. Using Programme Theory and Process Evaluation to Co-Create a Local Plan to Manage Intervention Fidelity and Adaptations
Henna Hasson and Ulrica Von Thiele Schwarz
28. Effectiveness-Implementation Hybrid Studies to Speed the Translation of Complex Health Interventions into Practice
Nathaniel J. Williams, Justin D. Smith, Sara J. Landes, and Geoffrey M. Curran
29. Designing Complex Health Innovations for Dissemination and Diffusion
Hubert W. Miller III and James W. Dearing
30. An Organisational Learning and Unlearning Perspective on Implementing Complex Interventions
Lauren MacEachern And Whitney Berta
31. Network Interventions in Dissemination and Implementation Research
Reza Yousefi-Nooraie
32. Integrated Knowledge Translation and Complex Interventions: Using Research Partnership to Respond to Context and Enhance Implementation Chris Mccutcheon, Anita Kothari, Ian Graham
33. Challenges Facing Implementation Science Researchers
Michel Wensing
34. Concluding Thoughts; Integrating the Guidance into Your Research Programme
Ingalill Rahm Hallberg
Biography
Executive Editors
David A. Richards, Executive Editor
David is Professor at the Western Norway University of Applied Sciences; Emeritus Professor at the University of Exeter, United Kingdom (UK); and Emeritus Senior Investigator for the UK National Institute for Health and Social Care Research. A nurse and psychological therapist by professional background, he has also been President of the European Academy of Nursing Science and was inaugural Head of Nursing at the University of Exeter. David has been at the forefront of national and international efforts to improve access to treatment for those suffering from high-prevalence mental health problems, such as depression and anxiety. As a senior research leader, he challenges the health and social care research community to reduce waste in their work by refocussing their research activity towards clinically relevant programmes, however complex, driven by the uncertainties of health service practice and the real concerns of the public, patients, and clinicians. To this end he was Joint Editor with Ingalill of the first edition of this textbook, intended as it was to equip researchers in the design, planning, and implementation of programmatic, mixed-methods, and complex interventions research. This second edition represents his ambition to ensure these constituencies have comprehensive access in this new volume to the most recent developments in complex interventions research methods.
Ingalill Rahm Hallberg, Executive Editor
Ingalill is Professor Emeritus of Health Care Science at Lund University, Sweden, and has been the Pro-Dean of the Medical Faculty, Assistant Vice-Chancellor, and Pro-Vice Chancellor of Lund University. She is a registered nurse by profession, and after she obtained her PhD, her research has been on ageing, care, and services for older people and people living with severe diseases, an area in which she has been at the forefront nationally and internationally. Early in her career, she got a large grant to build up a national institute for interdisciplinary research in which researching interventions in health care was an important component. Her frequent involvement in reviewing research proposals, research at universities, and research by national and international groups inspired her to initiate a debate on how research was too often scattered, lacking long-term coherent programmes, and dominated by descriptive studies, with no ability to have an impact on health care. As the previous President of the European Academy of Nursing Science, together with Professor Richards, she was a driving force in changing the unwelcome preponderance of small-scale, descriptive projects among European PhD students.
Editors
Carole A. Estabrooks, Editor
Carole is a Professor at the University of Alberta and holds a Tier 1 Canada Research Chair in Knowledge Translation. She is Scientific Director of the pan-Canadian Translating Research in Elder Care (TREC) research program. TREC is focused on improving resident quality of life and quality of care, and staff quality of work life using implementation and improvement science methods in long-term care (nursing) homes. She is a graduate of the University of New Brunswick (undergraduate), the University of Alberta (graduate degrees), and did her postdoctoral fellowship at the Clinical Institute for Evaluative Sciences and University of Toronto. During her postgraduate and postdoctoral work, she was supported by fellowships from the Alberta Foundation for Medical research, the Medical Research Council of Canada, and the Canadian Institutes of Health Research fellowships. She is a member of the Order of Canada (Canada’s highest civilian honour) and an elected Fellow in the Royal Society of Canada, the Canadian Academy of Health Sciences, the American Academy of Nurses, and the Canadian Academy of Nurses.
Sascha Köpke, Editor
Sascha is Professor of Clinical Nursing Science and head of the Institute of Nursing Science at the University of Cologne Medical Faculty. He is a nurse by training and has worked clinically in intensive care in Germany and the UK. His research interests cover quality of care in long-term and acute care settings and the development, evaluation, and long-term implementation of complex interventions to improve care in different settings. Also, he has performed research on nurse-led decision support and evidence-based patient information in people with chronic diseases and has a focus on evidence synthesis. He is currently Vice President of the German Society of Nursing Science, fellow of the European Academy of Nursing Science, and Cochrane senior editor.
Gabriele Meyer, Editor
Gabriele is Professor of Health and Nursing Science at Martin Luther University Halle-Wittenberg, Halle (Saale), Germany. She has been Director of the Institute for Health, Midwifery and Nursing Science since 2013. Gabriele is a nurse by profession and has spent more than a decade working in hospitals and community nursing. Her research is on old-aged, care-dependent people and, therein, the development and evaluation of complex interventions aimed to reduce physical restraints and inappropriate psychotropic medication, to increase social participation, and to improve dementia care. Like Ingalill and David, she was President of the European Academy of Nursing Science for six years and, beforehand, Vice President and Board Member. Gabriele held positions in national policy advisory bodies for many years, for example, the National Advisory Board for the Assessment of the Development of the German Health Care System or the German Ethics Council. She is Editor-in-Chief of The Journal of Evidence and Quality in Health Care and, since last year, board member of the German Society of Nursing Science.
Lars Wallin, Editor
Lars is a Senior Professor in Nursing focused on implementation research at the University of Dalarna. He defended his PhD in 2003 on a thesis on the development and implementation of national guidelines in neonatal nursing, at that time, one of the first to do research on implementation processes in Swedish healthcare. He did his postdoctoral studies at the University of Alberta in Canada and then worked at Karolinska Institute, Sweden, in various research positions. He was appointed as Professor in 2012, which was combined with acting as research director in the Dalarna region in Sweden. Among other projects, he has participated in leading cluster randomised studies in various national and international contexts, where facilitation and reminder systems as implementation strategies have been evaluated. In recent years, his research has focused on learning more about the implementation of person-centred care.
Yvonne Wengström, Editor
Yvonne is an oncology nurse and has worked in cancer care since 1989. She holds a PhD in oncology and is Professor of Nursing at the Karolinska Institute (KI), Sweden. She holds a joint position between the university and the hospital and is Professor at the Karolinska Comprehensive Cancer Centre at the Karolinska University Hospital. She leads a research team at the Department of Nursing at the Department of Neurobiology, Care Sciences and Society, KI. The MRC frameworks have guided her research program including a series of innovative intervention studies to bridge the research and practice gap, including intervention studies to support and optimise health during treatment for cancer, studies that include self-reported measures as well as biomarkers to support identification of predictors for patients suffering from severe symptoms and side effects during treatment. She is an advocate for transferring research outcomes into practice and a member of several international committees and has been the President of the European Oncology Nursing Society. She is one of the founding members of the global network for collaboration International Learning Collaborative (www.ilccare.org), which focuses on fundamentals of care by integrating clinical practice, research, and education to promote excellence in fundamental care and developing research evidence through systematic investigation of fundamentals of care in healthcare systems globally.
Joanne Woodford, Editor
Joanne is Associate Professor of Caring Sciences and Assistant Research Group Leader for the research group CIRCLE – Complex Intervention Research in Health and Care, at Uppsala University, Sweden. Her main research concerns improving access to psychological interventions for people living with common mental health problems, with a specific focus on people living with chronic physical health conditions and their informal caregivers. She is an expert in applying research methods informed by the MRC complex interventions framework, with a focus on intervention development and feasibility studies. She also has a special interest in embedding public participation, involvement, and engagement throughout the research lifecycle to increase the relevance, acceptability, and usefulness of planned research.
“This new edition will be welcomed by health services and public health researchers as a valuable companion to the most recent version of the MRC/NIHR guidance on developing and evaluating complex interventions. It provides extended guidance on the entire process from intervention development through to implementation, covering all the standard methods but also newer ones such as evaluability assessment, microsimulation modelling and hybrid designs. An indispensable resource for both research and teaching.”
— Peter Craig, Professor of Public Health Evaluation, University of Glasgow, UK“Complex interventions lie at the intersection of science, practice, and human experience. As a nurse, educator, and immigrant who has long advocated for equity in health, I see in this book an indispensable resource for addressing the complexity of care in diverse contexts. By uniting rigorous methodology with a deep awareness of social realities, the authors offer a roadmap for developing, evaluating, and implementing interventions that not only advance scientific knowledge but also respond meaningfully to the needs of populations."
— Azita Emami, Dean and Linda Koch Lorimer Professor of Nursing, Yale School of Nursing, USA“This book is an important guide for anyone aiming to work with complex interventions. It offers clear insights into designing, implementing and evaluating composite programs. Complex interventions illustrate the need for several levels of perspectives when performing interventions in humans, i.e., societal, organisational and individual. This updated edition therefore fills a gap of knowledge, greatly anticipated. New perspectives have been added, such as the usability of longitudinal big data in addition to or as part of interventions. This methodology oriented edition will be of great use for the scientific community and inspire anyone committed to improving health outcomes.”
— Maria Eriksdotter, Professor in Geriatric Medicine Karolinska Institutet, Sweden, and President Advisor for Cooperation with the Health Care System"The demographic and social challenges facing health and social care require complex responses from services, tailored to the needs of particular populations. If we are to respond effectively, we need sophisticated approaches to the development, evaluation and implementation of complex interventions. This book, written by key experts in the field, provides an invaluable roadmap for researchers, practitioners and policy makers."
— Stuart Logan, Professor of Paediatric Epidemiology, University of Exeter, UK and Director - NIHR PenARC, UK"Complex interventions require a diverse and flexible set of research approaches. This updated edition of Complex Interventions in Health: An Overview of Research Methods delivers a clear and comprehensive guide, thoughtfully organised around the key phases of the MRC Framework. It is an invaluable resource for students, experienced researchers, and practitioners alike, offering both foundational knowledge and practical insights into designing, assessing feasibility, evaluating and implementing complex interventions."
— Kerstin Svensson, Professor, Social Worker and Vice-Chair for the Swedish Research Council for Health Working Life and Welfare, Sweden"This is an outstanding and timely contribution to the field of health and social care research. Extensively updated in line with the UK Medical Research Council’s most recent guidance, this textbook provides a rigorous and practical roadmap for understanding, designing, evaluating, and implementing complex interventions. The authors outline the full research cycle from conceptual development and feasibility testing to evaluation and implementation, while maintaining a strong emphasis on theory, engagement of interested parties, and real-world context. This book aims to make the messiness of complex interventions accessible and feasible. As such, it is useful for learners, clinicians, and researchers as it provides a comprehensive foundation and a reference for collaborative and impactful research endeavours."
— Sharon Straus, Professor, Department of Medicine, Temerty Faculty of Medicine, University of Toronto and Director, Knowledge Translation Program
