Bias | Authors' judgement | Support for judgement |
---|---|---|
Random sequence generation (selection bias) | Unclear risk |
Quote: “The process of randomisation was as follows. The communities were placed into three strata based on the distance of the clinic from a tarred road. There were 16 299 360 ways that the 30 communities could be allocated to the two arms ensuring balance across these strata. Randomisation was then restricted to ensure an equal number of schools in each arm; balance across districts; and an average sample size per community between 255 and 261 in each arm. The 8575 allocations satisfying these conditions were listed, and one was selected randomly at the randomisation meeting.”—Cogan 2008 Comment: insufficient information to permit judgement |
Allocation concealment (selection bias) | Low risk | Comment: intervention and comparison sites were different |
Similar baseline characteristics | Unclear risk | |
Similar baseline outcome measurement | Unclear risk | |
Blinding of participants and personnel (performance bias) | Low risk | Comment: participants could not be blinded due to the nature of the intervention |
Blinding of outcome assessment (detection bias) | Unclear risk | Comment: insufficient information to permit judgement |
Incomplete outcome data (attrition bias) | High risk | Comment: high amount of loss to follow up from both intervention and control groups |
Prevention of knowledge of allocated intervention | Unclear risk | |
Protection against contamination | Unclear risk | |
Selective reporting (reporting bias) | Unclear risk | Comment: pre‐specified outcomes in the 2008 paper by the same author, were reported; but no protocol was found. |
Other bias | Low risk | Comment: the study appears to be free from other bias |