000			05889 am a22003613u 4500
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100	1	0	_aSkivington, Kathryn _eauthor _91940
700	1	0	_aMatthews, Lynsay _eauthor _91941
700	1	0	_aSimpson, Sharon Anne _eauthor _91942
700	1	0	_aCraig, Peter _eauthor _91943
700	1	0	_aBaird, Janis _eauthor _91944
700	1	0	_aBlazeby, Jane M _eauthor _91945
700	1	0	_aBoyd, Kathleen Anne _eauthor _91946
700	1	0	_aCraig, Neil _eauthor _91947
700	1	0	_aFrench, David P _eauthor _91948
700	1	0	_aMcIntosh, Emma _eauthor _91949
700	1	0	_aPetticrew, Mark _eauthor _91950
700	1	0	_aRycroft-Malone, Jo _eauthor _91951
700	1	0	_aWhite, Martin _eauthor _91952
700	1	0	_aMoore, Laurence _eauthor _91953
245	0	0	_aFramework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update
260			_c2021-09-01.
500			_a/pmc/articles/PMC7614019/
500			_a/pubmed/34590577
520			_aBACKGROUND: 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. FUTURE WORK: We call for further work to develop relevant methods and provide examples in practice. The use of this framework should be monitored and the move should be made to a more fluid resource in the future, for example a web-based format that can be frequently updated to incorporate new material and links to emerging resources. 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).
540			_a
540			_ahttps://creativecommons.org/licenses/by/4.0/This is an Open Access publication distributed under the terms of the Creative Commons Attribution CC BY 4.0 licence, which permits unrestricted use, distribution, reproduction and adaption in any medium and for any purpose provided that it is properly attributed. See: https://creativecommons.org/licenses/by/4.0/. For attribution the title, original author(s), the publication source - NIHR Journals Library, and the DOI of the publication must be cited.
546			_aen
690			_aArticle
655	7		_aText _2local
786	0		_nHealth Technol Assess
856	4	1	_uhttp://dx.doi.org/10.3310/hta25570 _zConnect to this object online.
999			_c856 _d856