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Framework for Evaluating Complex Interventions

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Sasha Shepperd

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Overview of the chapter structure:

This chapter is divided into the following sections:

  • A framework for evaluating complex interventions
  • Knowledge translation, complex interventions and the iterative loop
  • Future research

Key Learning Points

  • The active ingredient(s) of complex interventions can be difficult to identify
  • Stakeholders can inform trialists on which element(s) of a complex intervention are essential to reproduce
  • Other types of evidence can improve the relevance of trials for policy makers
  • The MRC Framework for the Development and Evaluation of Randomised Controlled Trials for Complex Interventions to Improve Health1 provides a mechanism for formally integrating other types of evidence and may support the transfer of evidence based interventions
  • External validity can be strengthened through the involvement of key health care decision makers

A Framework for Evaluating Complex Interventions

The MRC Framework provides an iterative step wise approach to determine the state of knowledge about a complex intervention

MRC Framework for Evaluating Complex Interventions

  • Step 1 Defining the intervention

    • Identify the existing evidence and any theoretical basis for the intervention in order to describe the components of the intervention
  • Step 2 An exploratory phase

    • Assess the acceptability and feasibility of delivering the intervention, and the comparison intervention
    • Pilot the study design
  • Step 3 An explanatory phase

    • The final trial design is implemented in a relevant setting with appropriate eligibility criteria
  • Step 4 A pragmatic phase

    • Implementation and fidelity are examined
    • Key to KT
MRC Framework for Evaluating Complex Interventions
Campbell, M. et al. BMJ 2000;321:694-696
MRC Framework for Evaluating Complex Interventions
Campbell, M. et al. BMJ 2000;321:694-696

Knowledge Translation, Complex Interventions and the Iterative Loop

  • Involve decision makers in shaping the research question and defining the intervention
  • Systematically identify and integrate additional forms of evidence relevant to decision makers
  • Measure outcome and process variables relevant to KT
  • Measure degree the intervention has been sustained outside a research setting
  • Be aware of a changing political context

Areas for Future Research

  • Generate empirical evidence to assess the benefits of involving stakeholders, in the design phase of research, on subsequent implementation
  • Research describing the iterative process, how key decision makers are identified and contribute to decision making

1Campbell M, Fitzpatrick R, Haines A, Kinmouth A-L, Sandercock P, Spiegelhalter D. A framework for development and evaluation of RCTs for complex interventions to improve health. BMJ 2000;321:694-6.