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Quality and Reporting of Cluster Randomised Controlled Trials Evaluating Occupational Therapy Interventions: A Systematic Review

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Journal Article

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Sage

Abstract

Background: Growing use of the cluster randomised control trials (RCTs) in healthcare research requires careful attention to study designs, with implications for the development of an evidence-base for practice. Objective: To investigate the characteristics, quality and reporting of cluster-RCTs evaluating occupational therapy interventions to inform future research design. Methods: An extensive search of cluster-RCTs evaluating occupational therapy was conducted in several databases. Results: Fourteen studies met our inclusion criteria; four were protocols. Eleven (79%) justified the use of a cluster-RCT and accounted for clustering in the sample size and analysis. All full studies reported the number of clusters randomised and five reported ICCs (50%): protocols had higher compliance. Risk of bias was most evident in blinding of participants. Statistician involvement was associated with improved trial quality and reporting. Conclusions: Quality of cluster-RCTs of occupational therapy interventions is comparable to those from other areas of health research and needs improvement.

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OTJR: Occupational Therapy Journal of Research. 2015;36(1):14-24. doi:10.1177/1539449215618625

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This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 3.0 License (http://www.creativecommons.org/licenses/by-nc/3.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page(https://us.sagepub.com/en-us/nam/open-access-at-sage).