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 unblinding 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.
| Original language | English |
|---|---|
| Pages (from-to) | 14-24 |
| Number of pages | 11 |
| Journal | Occupation, Participation and Health |
| Volume | 36 |
| Issue number | 1 |
| DOIs | |
| Publication status | Published - 23 Dec 2015 |
Bibliographical note
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).Keywords
- cluster randomized controlled trials
- methods
- occupational therapy
- research design
- systematic review