Cluster randomised trials: a study to help recommendations for better reporting in Cochrane reviews

Article type
Authors
Richardson M1, Donegan S1, Garner P1
1Cochrane Infectious Diseases Group, United Kingdom
Abstract
Background:
For some clinical indications, cluster-randomised controlled trials (C-RCTs) are commonly carried out and included in reviews. C-RCTs differ in design to individually randomised controlled trials, in that clusters of subjects (such as schools, communities, clinics) are randomly assigned to intervention and control groups. Ideally, reviews containing C-RCTs should report several specific details about the cluster trial itself, perform risk of bias assessments appropriate for C-RCTs, and ensure analyses are correctly adjusted for clustering. Failure to consider such issues may lead to serious error and misinterpretation.

Objective:
We aimed to examine whether Cochrane review authors addressed the inclusion of C-RCTs in their reviews appropriately.

Methods:
We included Cochrane reviews including C-RCTs, and excluded diagnostic test accuracy reviews and withdrawn reviews. We searched the Cochrane Database of Systematic Reviews for reviews published in the last two years and assessed eligibility using a form. We obtained the review and included C-RCT trial reports to verify that trials were correctly reported in the review. We devised a number of criteria based on published literature to assess the quality of the review regarding the inclusion of C-RCTs. We extracted data from each review and C-RCT trial report including whether an appropriate risk of bias assessment was performed, and whether there were analyses accounting for clustering.

Results:
We will present results regarding the general characteristics of the reviews and results from the quality assessment of the reviews regarding the inclusion of C-RCTs.

Conclusions:
We will highlight areas for improvement in the reporting of C-RCTs in future reviews, and make clear recommendations for review authors based on our findings.