Bias | Authors' judgement | Support for judgement |
---|---|---|
Random sequence generation (selection bias) | Low risk |
Quote: “The study statistician (JL) based in Pretoria, who had no knowledge of the study area, randomly generated the allocation sequence for each stratum. Then enrolled participants.” Comment: random sequence generation was adequately done |
Allocation concealment (selection bias) | Low risk |
Quote: “The study statistician (JL) based in Pretoria, who had no knowledge of the study area, randomly generated the allocation sequence” Comment: allocation was adequately concealed |
Similar baseline characteristics | Unclear risk | |
Similar baseline outcome measurement | Unclear risk | |
Blinding of participants and personnel (performance bias) | Low risk | Comment: personnel (field workers and interviewers) could not be blinded and were used for quality control of the measures. There was active recruiting the villages for participants in the study, again given the nature of the intervention blinding was not possible. |
Blinding of outcome assessment (detection bias) | Low risk |
Quote: “All blood tests were conducted blind to the treatment arm” Comment: outcome assessment was blind |
Incomplete outcome data (attrition bias) | Low risk |
Quote: “No clusters were lost to follow‐up.” “Loss to follow‐up was mainly because participants had moved and could not be located.” Comment: missing outcome data is balanced across groups |
Prevention of knowledge of allocated intervention | Unclear risk | |
Protection against contamination | Unclear risk | |
Selective reporting (reporting bias) | Unclear risk | Comment: insufficient information to permit judgement and no protocol was found. |
Other bias | Low risk | Comment: no evidence to suggest this |