CONSORT checklist items reported in N (%) articles | RCTs (N=95) | cRCTs (N=40) | Total (N=135) |
All items | 12 (13%) | 1 (3%) | 13 (10%) |
Sequence generation method (8a) | 54 (59%) | 16 (42%) | 70 (54%) |
Sequence generation type | 46 (53%) | 9 (28%) | 55 (41%) |
Type of randomisation (8b) | 46 (53%) | 13 (34%) | 59 (47%) |
Details of stratification or matching (extension 8b) | na | 15 (45%) | 15 (14%) |
Allocation concealment | 27 (32%) | 8 (20%) | 35 (26%) |
Mechanisms to conceal sequence until allocation (9) | 27 (32%) | 10 (26%) | 37 (30%) |
Concealment at cluster or individual level (extension 9) | na | 12 (34%) | 12 (11%) |
Implementation of randomisation | 21 (26%) | 2 (3%) | 23 (17%) |
Who generated sequence, who enrolled, who assigned (10) | 21 (26%) | na | 21 (18%) |
Who generated sequence, who enrolled clusters, who assigned (10a) | na | 6 (15%) | 6 (5%) |
How were individual participants included in clusters (10b) | na | 17 (43%) | 17 (13%) |
Who gave consent and when (10c) | na | 19 (44%) | 19 (14%) |
CONSORT, Consolidated Standards of Reporting Trials; cRCTs, cluster randomised controlled trial; na, not applicable; RCTs, randomised controlled trial.