Abstract

The integration of realist evaluation principles within randomised controlled trials (‘realist RCTs’) enables evaluations of complex interventions to answer questions about what works, for whom and under what circumstances. This allows evaluators to better develop and refine mid-level programme theories. However, this is only one phase in the process of developing and evaluating complex interventions. We describe and exemplify how social scientists can integrate realist principles across all phases of the Medical Research Council framework. Intervention development, modelling, and feasibility and pilot studies need to theorise the contextual conditions necessary for intervention mechanisms to be activated. Where interventions are scaled up and translated into routine practice, realist principles also have much to offer in facilitating knowledge about longer-term sustainability, benefits and harms. Integrating a realist approach across all phases of complex intervention science is vital for considering the feasibility and likely effects of interventions for different localities and population subgroups.

Highlights

  • The original UK Medical Research Council (MRC) framework for evaluating complex interventions recommended sequential phases of development, feasibility testing and evaluation, culminating in the estimation of an effect size via a randomised controlled trial (RCT), prior to wider implementation (Campbell et al, 2000)

  • Effect sizes may tell us that an intervention helped more people than it harmed in the time and place it was delivered, but often tell policymakers and practitioners little regarding how findings might be applied in new settings or to other populations (Cartwright and Hardie, 2012)

  • The cumulative effect of these processes should be the generation of a strong theoretical and evidence base for public health intervention which provides greater confidence that outcomes observed during trials can be replicated in real-world settings, and which supports the ongoing cycle of developing and evaluation complex interventions

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Summary

Introduction

The original UK Medical Research Council (MRC) framework for evaluating complex interventions recommended sequential phases of development, feasibility testing and evaluation, culminating in the estimation of an effect size via a randomised controlled trial (RCT), prior to wider implementation (Campbell et al, 2000). New MRC guidance on integrating process evaluation within trials of complex interventions endorses the use of RCTs that integrate qualitative data collection and analysis focussed on the interactions between mechanisms, context and outcomes (Moore et al, 2014, 2015).

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