Section 3.6.2: Framework for Evaluating Complex Interventions

[ Table of Contents ]

Sasha Shepperd

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

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.

Date modified:

2010-08-09