Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions

Trials, Jul 2014

Background The Medical Research Councils’ framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. Methods We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. Results Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. Conclusions Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology. Trial registration Clinical trials.gov: NCT02160249

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Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions

Trials Mary J De Silva 2 Erica Breuer 1 Lucy Lee 2 Laura Asher 2 Neerja Chowdhary 0 Crick Lund 1 Vikram Patel 0 2 0 Sangath , Alto-Porvorim, Bardez, Goa 403521 , India 1 Department of Psychiatry and Mental Health, Alan J Flisher Centre for Public Mental Health, University of Cape Town , 46 Sawkins Road, Rondebosch, 7700 Cape Town , South Africa 2 Centre for Global Mental Health, London School of Hygiene and Tropical Medicine , Keppel Street, London WC1E 7HT , UK - Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions De Silva et al. Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions Background: The Medical Research Councils framework for complex interventions has been criticized for not including theory-driven approaches to evaluation. Although the framework does include broad guidance on the use of theory, it contains little practical guidance for implementers and there have been calls to develop a more comprehensive approach. A prospective, theory-driven process of intervention design and evaluation is required to develop complex healthcare interventions which are more likely to be effective, sustainable and scalable. Methods: We propose a theory-driven approach to the design and evaluation of complex interventions by adapting and integrating a programmatic design and evaluation tool, Theory of Change (ToC), into the MRC framework for complex interventions. We provide a guide to what ToC is, how to construct one, and how to integrate its use into research projects seeking to design, implement and evaluate complex interventions using the MRC framework. We test this approach by using ToC within two randomized controlled trials and one non-randomized evaluation of complex interventions. Results: Our application of ToC in three research projects has shown that ToC can strengthen key stages of the MRC framework. It can aid the development of interventions by providing a framework for enhanced stakeholder engagement and by explicitly designing an intervention that is embedded in the local context. For the feasibility and piloting stage, ToC enables the systematic identification of knowledge gaps to generate research questions that strengthen intervention design. ToC may improve the evaluation of interventions by providing a comprehensive set of indicators to evaluate all stages of the causal pathway through which an intervention achieves impact, combining evaluations of intervention effectiveness with detailed process evaluations into one theoretical framework. Conclusions: Incorporating a ToC approach into the MRC framework holds promise for improving the design and evaluation of complex interventions, thereby increasing the likelihood that the intervention will be ultimately effective, sustainable and scalable. We urge researchers developing and evaluating complex interventions to consider using this approach, to evaluate its usefulness and to build an evidence base to further refine the methodology. Trial registration: Clinical trials.gov: NCT02160249 * Correspondence: 1Centre for Global Mental Health, London School of Hygiene and Tropical Medicine, Keppel Street, London WC1E 7HT, UK Full list of author information is available at the end of the article Background The updated Medical Research Council (MRC) framework for complex interventions [1] is a set of guidelines for designing and evaluating complex interventions which has been widely influential in the field [2]. The framework emphasizes four phases of intervention development, feasibility and piloting, evaluation, and implementation which take place as an iterative rather than a linear process. However, the MRC framework has been criticized for not including theory-driven approaches to evaluation [3]. Although the framework does reference theory-driven approaches, it does not explicitly recommend any, or provide guidance on how to incorporate them into the design and evaluation of complex interventions [1]. The evaluation of complex interventions has also been criticized for not providing a clear explanation of the mechanisms of change through which the intervention leads to real-world impact, and for not examining how the intervention interacts with context [4]. These omissions reflect the paucity of practical examples of the use of theory-driven approaches that have been shown to work, resulting in calls for researchers to provide such examples so that the MRC framework can reflect current best practice [2,3,5]. In order to develop complex interventions which are more likely to be effective, sustainable and scalable, evaluators need to understand not just whether, but how and why an intervention has a particular effect, and which parts of a complex intervention have the greatest impact on outcomes. For this, a prospective, theorydriven process of intervention design and evaluation is required. In this ar (...truncated)


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Mary J De Silva, Erica Breuer, Lucy Lee, Laura Asher, Neerja Chowdhary, Crick Lund, Vikram Patel. Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions, Trials, 2014, pp. 267, 15, DOI: 10.1186/1745-6215-15-267