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Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update.

  • Skivington, Kathryn1
  • Matthews, Lynsay1
  • Simpson, Sharon Anne1
  • Craig, Peter1
  • Baird, Janis2
  • Blazeby, Jane M3
  • Boyd, Kathleen Anne4
  • Craig, Neil5
  • French, David P6
  • McIntosh, Emma4
  • Petticrew, Mark7
  • Rycroft-Malone, Jo8
  • White, Martin9
  • Moore, Laurence1
  • 1 Medical Research Council/Chief Scientist Office Social and Public Health Sciences Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
  • 2 Medical Research Council Lifecourse Epidemiology Unit, University of Southampton, Southampton, UK.
  • 3 Medical Research Council ConDuCT-II Hub for Trials Methodology Research and Bristol Biomedical Research Centre, University of Bristol, Bristol, UK.
  • 4 Health Economics and Health Technology Assessment Unit, Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.
  • 5 Public Health Scotland, Glasgow, UK.
  • 6 Manchester Centre for Health Psychology, University of Manchester, Manchester, UK.
  • 7 London School of Hygiene and Tropical Medicine, London, UK.
  • 8 Faculty of Health and Medicine, Lancaster University, Lancaster, UK.
  • 9 Medical Research Council Epidemiology Unit, University of Cambridge, Cambridge, UK.
Published Article
Health technology assessment (Winchester, England)
Publication Date
Sep 01, 2021
DOI: 10.3310/hta25570
PMID: 34590577


Interventions are actions taken to make a change, for example heart surgery, an exercise programme or a smoking ban in public. Interventions are described as complex if they comprise several stages or parts or if the context in which they are delivered is complex. A framework on how to develop and evaluate complex interventions was last published by the Medical Research Council in 2006 (Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and Evaluating Complex Interventions. London: Medical Research Council; 2006). This document describes how the framework has been updated to include advances in research methods and thinking and presents the new framework document. The updating process had four stages: (1) review of the literature to identify areas requiring update; (2) workshop of experts to discuss topics to update; (3) open consultation on a draft of the framework; and (4) writing the framework. The updated framework divides the research process into four phases: development, feasibility, evaluation and implementation. Key updates include: the definition of a complex intervention was changed to include both the content of the intervention and the context in which it is conductedaddition of systems thinking methods: an approach that considers the broader system an intervention sits withinmore emphasis on interventions that are not developed by researchers (e.g. policy changes and health services delivery)emphasis on the usefulness of evidence as the key goal of complex intervention researchidentification of six elements to be addressed throughout the research process: context; theory refinement and testing; stakeholder involvement; identification of key uncertainties; intervention refinement; and economic considerations. The updated framework is intended to help those involved in funding and designing research to consider a range of approaches, questions and methods and to choose the most appropriate. It also aims to help researchers conduct and report research that is as useful as possible to users of research.

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