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. 2016 Nov 17;6(11):e013325. doi: 10.1136/bmjopen-2016-013325

Table 2.

Assessment of risk of bias of RCT included in systematic review

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.