A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance, 2021, Skivington et al

Summary points

• Complex intervention research can take an efficacy, effectiveness, theory based, and/or systems perspective, the choice of which is based on what is known already and what further evidence would add most to knowledge
  
  
• Complex intervention research goes beyond asking whether an intervention works in the sense of achieving its intended outcome—to asking a broader range of questions (eg, identifying what other impact it has, assessing its value relative to the resources required to deliver it, theorising how it works, taking account of how it interacts with the context in which it is implemented, how it contributes to system change, and how the evidence can be used to support real world decision making)
  
  
• A trade-off exists between precise unbiased answers to narrow questions and more uncertain answers to broader, more complex questions; researchers should answer the questions that are most useful to decision makers rather than those that can be answered with greater certainty
  
  
• Complex intervention research can be considered in terms of phases, although these phases are not necessarily sequential: development or identification of an intervention, assessment of feasibility of the intervention and evaluation design, evaluation of the intervention, and impactful implementation
  
  
• At each phase, six core elements should be considered to answer the following questions:
  
  • How does the intervention interact with its context?
    
    
  • What is the underpinning programme theory?
    
    
  • How can diverse stakeholder perspectives be included in the research?
    
    
  • What are the key uncertainties?
    
    
  • How can the intervention be refined?
    
    
  • What are the comparative resource and outcome consequences of the intervention?
    
• The answers to these questions should be used to decide whether the research should proceed to the next phase, return to a previous phase, repeat a phase, or stop

https://www.bmj.com/content/374/bmj.n2061

 

This framework was part of a course I took in how to design complex interventions. I really enjoyed the focus on stakeholder (often patients) perspectives and having the researcher write down the assumptions and predicted effects clearly building a so-called program theory and logic model that could be shared together with the study protocol and/or when results are disseminated.