Complex Interventions in Health An Overview of Research Methods

Extensively updated in light of the UK Medical Research Council's (MRC) latest guidance on complex intervention research methods in health and social care, this important book provides the most comprehensive resource available to understand and apply the range of methodologies available to researchers and practitioners today.

After an introductory chapter detailing the history of, and future challenges for, complex interventions research, and two chapters on patient and public involvement, the book is split into four discrete but interconnected parts:

• Section I explores the development phase of complex interventions, covering theory building, adaptation of existing interventions, stakeholder involvement, and context consideration--setting the foundation for successful research programs.
• Section II examines feasibility testing of complex interventions, addressing uncertainties in intervention design, methodology, and procedures before determining whether to stop, amend, or proceed to full evaluation.
• Section III presents evaluation methodologies for complex interventions, covering trial designs, process evaluation, economic assessment, data registries, population approaches, theory-based methods, and simulation modelling.
• Section IV addresses implementation science methodologies for translating complex interventions into practice, addressing theories, adaptation, hybrid designs, diffusion, and collaborative approaches.

The concluding chapter asks readers to reflect on the importance of initiating collaborative, programmatic research groups.

With a renewed focus on the context of complex interventions, including concise summaries of the latest thinking, this is essential reading for any researcher or practitioner in health and social care.

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 an 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 the 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, the assistant vice-chancellor and pro-vice chancellor of Lund University. She is a registered nurse by profession and after obtaining her PhD her research has been on ageing, care and services for older people and 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 programs 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 to change the unwelcome preponderance of small-scale, descriptive projects among European PhD students.

Editors

Carole Estabrook, 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 a 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 the 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 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, e.g. 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 post-doctoral studies at the University of Alberta in Canada and then worked at Karolinska Institute, Sweden in various research positions. He was appointed as a 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 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, that 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.