Table 2.
Cochrane risk of bias tool domains* | Review authors’ judgement | Support for review authors’ judgement |
---|---|---|
Sequence generation | Unclear | Authors reported that leaders were stratified based on gender, geographical location and type of group, and block randomised by a statistician. They did not provide information on how the randomisation sequence was generated. |
Allocation concealment | Unclear | No information provided on allocation concealment method. |
Blinding of participants, personnel and outcome assessors | High | Blinding of participants and personnel was not possible due to nature of the intervention. Outcomes were self-reported by participants, who were not blinded. |
Incomplete outcome data | Unclear | Approximately 20% missing data in both trial arms and not included in final analyses. |
Selective outcome reporting | Low | Authors reported small, non-significant effect sizes for included outcomes. In addition, although not a prespecified outcome of the systematic review, they reported emotional distress, which was higher (non-significant) in the high-resource arm. |
Other bias | Low | None |
*See online supplementary file 3 for domain descriptions. Domains are scored as ‘high’, ‘low’ or ‘uncertain’ risk of bias. Risk of bias ratings were based only on published information.
RCT, randomised controlled trial.