Development and evaluation of complex interventions

Abstract

Interventions are measures taken to make a change, such as heart surgery, an exercise program, or a ban on smoking in public. Interventions are called complex if they consist of several phases or parts, or if the context in which they are implemented is complex.

The UK Medical Research Council last published a framework for how to develop and evaluate complex interventions in 2006. This document describes how the framework has been updated to take account of developments in research methods and thinking and describes the new framework document.

The key updates include:

1. The definition of a complex intervention has changed: in addition to the content of the intervention, it includes the circumstances and context in which it is delivered.
2. The addition of systems science methods: an approach that takes into account the broader system of the intervention.
3. A greater emphasis on interventions developed by non-researchers (e.g. policy changes and health service delivery).
4. Emphasis on the utility of evidence as a key aim of complex intervention research.
5. Identify six elements that research should address: context; refining and testing program theory; stakeholder engagement; identifying key uncertainties; refining the intervention; and economic considerations.

The updated framework is intended to help those involved in research funding and design to consider a wide range of approaches, questions, and methods and select the most appropriate one. It also aims to help researchers to conduct and report research in the most useful way for research users.