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Appears in Collections:Faculty of Health Sciences and Sport Journal Articles
Peer Review Status: Refereed
Title: Process evaluations for cluster randomised trials of complex interventions: a proposed framework for design and reporting
Author(s): Grant, Aileen
Treweek, Shaun
Dreischulte, Tobias
Foy, Robbie
Guthrie, Bruce
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Keywords: Process evaluation
Complex intervention
Cluster-randomised controlled trial
Issue Date: 12-Jan-2013
Citation: Grant A, Treweek S, Dreischulte T, Foy R & Guthrie B (2013) Process evaluations for cluster randomised trials of complex interventions: a proposed framework for design and reporting, Trials, 14, Art. No.: 15.
Abstract: Background  Process evaluations are recommended to open the ‘black box’ of complex interventions evaluated in trials, but there is limited guidance to help researchers design process evaluations. Much current literature on process evaluations of complex interventions focuses on qualitative methods, with less attention paid to quantitative methods. This discrepancy led us to develop our own framework for designing process evaluations of cluster-randomised controlled trials.  Methods  We reviewed recent theoretical and methodological literature and selected published process evaluations; these publications identified a need for structure to help design process evaluations. We drew upon this literature to develop a framework through iterative exchanges, and tested this against published evaluations.  Results  The developed framework presents a range of candidate approaches to understanding trial delivery, intervention implementation and the responses of targeted participants. We believe this framework will be useful to others designing process evaluations of complex intervention trials. We also propose key information that process evaluations could report to facilitate their identification and enhance their usefulness.  Conclusion  There is no single best way to design and carry out a process evaluation. Researchers will be faced with choices about what questions to focus on and which methods to use. The most appropriate design depends on the purpose of the process evaluation; the framework aims to help researchers make explicit their choices of research questions and methods.
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Rights: © Grant et al.; licensee BioMed Central Ltd. 2013 This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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