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

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dc.contributor.authorDe Silva, Mary J
dc.contributor.authorBreuer, Erica
dc.contributor.authorLee, Lucy
dc.contributor.authorAsher, Laura
dc.contributor.authorChowdhary, Neerja
dc.contributor.authorLund, Crick
dc.contributor.authorPatel, Vikram
dc.date.accessioned2015-07-30T04:01:54Z
dc.date.available2015-07-30T04:01:54Z
dc.date.issued2014-07-05
dc.date.updated2015-01-15T17:58:54Z
dc.description.abstractAbstract 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
dc.identifier.apacitationDe Silva, M. J., Breuer, E., Lee, L., Asher, L., Chowdhary, N., Lund, C., & Patel, V. (2014). Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions. <i>Trials</i>, http://hdl.handle.net/11427/13616en_ZA
dc.identifier.chicagocitationDe Silva, Mary J, Erica Breuer, Lucy Lee, Laura Asher, Neerja Chowdhary, Crick Lund, and Vikram Patel "Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions." <i>Trials</i> (2014) http://hdl.handle.net/11427/13616en_ZA
dc.identifier.citationDe Silva, M. J., Breuer, E., Lee, L., Asher, L., Chowdhary, N., Lund, C., & Patel, V. (2014). Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions. Trials, 15(1), 267.
dc.identifier.ris TY - Journal Article AU - De Silva, Mary J AU - Breuer, Erica AU - Lee, Lucy AU - Asher, Laura AU - Chowdhary, Neerja AU - Lund, Crick AU - Patel, Vikram AB - Abstract 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 DA - 2014-07-05 DB - OpenUCT DO - 10.1186/1745-6215-15-267 DP - University of Cape Town J1 - Trials LK - https://open.uct.ac.za PB - University of Cape Town PY - 2014 T1 - Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions TI - Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions UR - http://hdl.handle.net/11427/13616 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/13616
dc.identifier.urihttp://dx.doi.org/10.1186/1745-6215-15-267
dc.identifier.vancouvercitationDe Silva MJ, Breuer E, Lee L, Asher L, Chowdhary N, Lund C, et al. Theory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions. Trials. 2014; http://hdl.handle.net/11427/13616.en_ZA
dc.language.rfc3066en
dc.publisher.departmentDepartment of Psychiatry and Mental Healthen_ZA
dc.publisher.facultyFaculty of Health Sciencesen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.rightsThis is an Open Access article distributed under the terms of the Creative Commons Attribution License*
dc.rights.holderDe Silva et al.; licensee BioMed Central Ltd.
dc.rights.urihttp://creativecommons.org/licenses/by/2.0*
dc.sourceTrialsen_ZA
dc.source.urihttp://www.trialsjournal.com
dc.subject.otherComplex interventionsen_ZA
dc.subject.otherTheory of Changeen_ZA
dc.subject.otherMRC framework for complex interventionsen_ZA
dc.titleTheory of Change: a theory-driven approach to enhance the Medical Research Council's framework for complex interventions
dc.typeJournal Articleen_ZA
uct.type.filetype
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceArticleen_ZA
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