Quality and reporting of cluster randomised controlled trials evaluating occupational therapy interventions: A systematic review
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.