Background: The Medical Research Council published the second edition of its framework in 2006 on developing and evaluating complex interventions. Since then, there have been considerable developments in the field of complex intervention research. The objective of this project was to update the framework in the light of these developments. The framework aims to help research teams prioritise research questions and design, and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. Methods: There were four stages to the update: (1) gap analysis to identify developments in the methods and practice since the previous framework was published; (2) an expert workshop of 36 participants to discuss the topics identified in the gap analysis; (3) an open consultation process to seek comments on a first draft of the new framework; and (4) findings from the previous stages were used to redraft the framework, and final expert review was obtained. The process was overseen by a Scientific Advisory Group representing the range of relevant National Institute for Health Research and Medical Research Council research investments. Results: Key changes to the previous framework include (1) an updated definition of complex interventions, highlighting the dynamic relationship between the intervention and its context; (2) an emphasis on the use of diverse research perspectives: Efficacy, effectiveness, theory-based and systems perspectives; (3) a focus on the usefulness of evidence as the basis for determining research perspective and questions; (4) an increased focus on interventions developed outside research teams, for example changes in policy or health services delivery; and (5) the identification of six ‘core elements’ that should guide all phases of complex intervention research: Consider context; develop, refine and test programme theory; engage stakeholders; identify key uncertainties; refine the intervention; and economic considerations. We divide the research process into four phases: Development, feasibility, evaluation and implementation. For each phase we provide a concise summary of recent developments, key points to address and signposts to further reading. We also present case studies to illustrate the points being made throughout. Limitations: The framework aims to help research teams prioritise research questions and design and conduct research with an appropriate choice of methods, rather than to provide detailed guidance on the use of specific methods. In many of the areas of innovation that we highlight, such as the use of systems approaches, there are still only a few practical examples. We refer to more specific and detailed guidance where available and note where promising approaches require further development. Conclusions: This new framework incorporates developments in complex intervention research published since the previous edition was written in 2006. As well as taking account of established practice and recent refinements, we draw attention to new approaches and place greater emphasis on economic considerations in complex intervention research. We have introduced a new emphasis on the importance of context and the value of understanding interventions as ‘events in systems’ that produce effects through interactions with features of the contexts in which they are implemented. The framework adopts a pluralist approach, encouraging researchers and research funders to adopt diverse research perspectives and to select research questions and methods pragmatically, with the aim of providing evidence that is useful to decision-makers.
Bibliographical noteFunding Information:
Declared competing interests of authors: Additional time on the study was funded by grants from the Medical Research Council (MRC) for Kathryn Skivington (MC_UU_12017/11, MC_UU_00022/3), Lynsay Matthews, Sharon Anne Simpson, Laurence Moore (MC_UU_12017/14, MC_UU_00022/1), and Peter Craig (MC_UU_12017/15, MC_UU_00022/2). Additional time on the study was also funded by grants from the Chief Scientist Office of the Scottish Government Health Directorates for Kathryn Skivington (SPHSU11), Lynsay Matthews, Sharon Anne Simpson and Laurence Moore (SPHSU14), and Peter Craig (SPHSU13 and SPHSU15). Kathryn Skivington and Sharon Anne Simpson were also supported by a MRC Strategic Award (MC_PC_13027). Sharon Anne Simpson was a member of the National Institute for Health Research (NIHR) Clinical Evaluation and Trials Programme Panel (November 2016 to November 2020) and the Chief Scientist Office Health Improvement, Protection and Services Committee (2018 to present) at the time of commissioning and during the project, and was a member of the NIHR Policy Research Programme during the latter parts of the project (November 2019 to present). Janis Baird is a member of the NIHR Public Health Research (PHR) Programme Funding Committee (May 2019 to present). She is also a core member (since 2016) and vice chairperson (since 2018) of the National Institute for Health and Care Excellence (NICE) Public Health Advisory Committee C. Jane M Blazeby is a former member of the NIHR Clinical Trials Unit Standing Advisory Committee (2015–19). Jane M Blazeby is funded in part by the NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol. David P French is a former member of the NIHR PHR programme research funding board (2015–19) and a former member of the MRC–NIHR Methodology Research Panel (2014–18). David P French is funded in part by the NIHR Manchester Biomedical Research Centre (IS-BRC-1215-20007) and NIHR Applied Research Collaboration – Greater Manchester (NIHR200174). Emma McIntosh is a member of the NIHR PHR funding board panel. Jo Rycroft-Malone is programme director and chairperson of the NIHR’s Health Services Delivery Research programme (2014 to present) and is a member of the NIHR Strategy Board (2014 to present). Mark Petticrew is funded in part as director of the NIHR’s Public Health Policy Research Unit, and has funding as part of the MRC-funded TRIPLE C project (grant reference MR/S014632/1) and the NIHR School for Public Health Research at London School of Hygiene & Tropical Medicine. Martin White was funded in part as director of NIHR’s PHR programme (July 2014 to June 2020), which contributed funding to the project via the NIHR/MRC Methodology Research Programme. He is a member of the MRC’s Population Health Sciences Strategic Committee (July 2014 to June 2020). Laurence Moore was a member of the MRC–NIHR Methodology Research Programme Panel (2015–19) and MRC Population Health Sciences Group (2015–20) at the time of commissioning and early stages of the project.
Each session was facilitated by a member of the project team and was supported by a colleague from the MRC/Chief Scientist Office Social and Public Health Sciences Unit, University of Glasgow. Colleagues assisted the facilitators by taking notes of key points during each discussion, clarifying main points with attendees and producing a written summary of each discussion after the workshop. SAG members were also present in each discussion. Round-table discussions were audio-recorded. Throughout the day, participants were asked to provide their thoughts on key points, case study examples and key references on Post-it® notes (3M, Saint Paul, MN, USA) on dedicated noticeboards.
The writing of the framework was led by the project team and was supported by co-authors in the writing group and the SAG. Feedback was received at various stages throughout the writing process from members of the MRC’s Population Health Sciences Group (PHSG) and the MRC–NIHR Methodology Research Programme (MRP) Advisory Group.
Funding: This project was jointly funded by the Medical Research Council (MRC) and the National Institute for Health Research (Department of Health and Social Care 73514).
This project was jointly funded by the Medical Research Council (MRC) and NIHR (Department of Health and Social Care 73514).
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