Cluster Trials
The main CONSORT Statement provides recommendations for reporting parallel group randomized trials, in which individual participants are randomly assigned to health care interventions. Cluster trials, however, randomize interventions to groups of patients (e.g., families, medical practices) rather than to individual patients.
The main problem associated with their design, conduct, analysis, and interpretation, compared with individually randomized trials, is that two different units of measurement—the cluster and the patient—are used. Each needs to be reported carefully.
An extension to the CONSORT Statement for cluster randomized trials was developed in which recommendations for the reporting of these trials are presented. The paper discusses the methodology and gives an explanation of each suggested modification to the main CONSORT checklist.
Reference
Campbell MK, Elbourne DR, Altman DG. CONSORT statement: extension to cluster randomised trials. BMJ 2004; 328(7441):702-708. Full text PDF.
Campbell MJ, Elbourne D, Altman DG, for the CONSORT Group. CONSORT statement: extension to cluster randomized trials [Chinese]. Chin J Evid-Based Med 2006; 6(6):451-458.
Campbell
MK, Elbourne DR, Altman DG. The CONSORT statement for cluster
randomised trials [Spanish]. Med Clin (Barc) 2005; 125 Suppl 1:28-31.
PMID: 16464424
Visit the CONSORT database for additional literature on cluster trials.
Page last edited: 31 July 2007
