Table 1.

 Comparison of recommendations in extension to CONSORT for cluster randomised trials and variables abstracted for present study

CONSORT criterion	Criterion included in present study?	Description of variable abstracted for this review
1) Specify that allocation was based on clusters	Yes (reporting)	Clearly identified as cluster randomised trial in title or abstract
2) Rationale for using cluster design	Yes (reporting)	Justification provided for using clustered design
3) Eligibility criteria for participants and clusters	No	—
5) Interventions intended for individual level, cluster level, or both	No	—
5) Specific objectives for individual level, cluster level, or both	No	—
6) Report outcome measures for individual level, cluster level, or both	Yes (reporting)	Primary outcome identified clearly
7) How total sample size was determined including method of calculation, No of clusters, cluster size, coefficient of intracluster correlation	Yes (reporting)	Sample size calculation presented
	Yes (methodology)	Accounted for clustering in sample size
8) Method used to generate random allocation sequence	Yes (methodology)	Used stratification/matching/minimisation
9) Method used to implement random allocation sequence	No	—
10) Who generated allocation sequence and enrolled and assigned participants	Yes (reporting)	Identified who enrolled patients
11) Whether participants, those administering interventions, and those assessing outcomes were blinded to group assignment	Yes (reporting)	Reported on blinding of outcome assessors; reported on blinding of participants/administrators
12) Statistical methods used to compare groups for primary outcome(s) indicating how clustering was taken into account	Yes (reporting)	Reported methods of analysis
	Yes (methodology)	Accounted for clustering in analysis
13) Flow of clusters and individual participants through each stage	Yes (reporting)	Reported No of clusters randomised; reported No of individuals lost to follow-up; reported No of clusters lost to follow-up; reported No of clusters withdrew; reported size of clusters in each arm
14) Dates defining periods of recruitment and follow up	No	—
15) Baseline information for each group for individual and cluster levels	No	—
16) No of clusters and participants in each group included in each analysis and whether analysis was by intention to treat	Yes (reporting)	Similar to 13 above
	Yes (methodology)	Allocated minimum of four clusters per arm
17) For each outcome, summary of results for each group for individual or cluster level, and coefficient of intracluster correlation.	Yes (reporting)	Reported intracluster correlation
18) Address multiplicity by reporting any other analyses performed	No	—
19) All important adverse events or side effects in each intervention group	No	—
20) Interpretation of results (internal validity)	No	—
21) Generalisability (external validity)	No	—
22) Interpretation in context of current evidence	No	—