Methods | Cluster‐RCT Method to adjust for clustering: not adjusted (review authors adjusted using the ICC from Alderman 2006) Cluster unit: school Average cluster size: 33 ICCs: not reported Length of follow‐up: 2 years |
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Participants | All children living in endemic area Number analysed for primary outcome: 80 schools randomized containing 2659 children in class 3 Mean age: 104.5 months Inclusion criteria: children from class 3 and born in 1990 of 80/81 schools in the Red River delta of north Vietnam Exclusion criteria: none stated |
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Interventions | Multiple doses vs placebo
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Outcomes | Measured:
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Notes | Location: Vietnam Community category: 1 It is unclear what is meant by "randomization was adjusted so that there were equal numbers of schools in each district of the trial group". It is also appears as if the analysis has not taken into account the effects of cluster randomization. Source of funding not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "randomization was adjusted so that there were equal numbers of schools in each district of the trial group" (unclear what this means) |
Allocation concealment (selection bias) | Low risk | Central allocation. "...using a list provided by the Ministry of Education". |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Placebo was used, blinding not reported. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Insufficient reporting of attrition/exclusions. 80 schools containing 56,444 pupils randomized, and those from class 3 used in trial. Inclusion of all randomized participants (number evaluable/number randomized): unclear; 80 schools containing 56,444 pupils randomized, and those from class 3 used in trial. |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported. |
Other bias | Low risk | Although not adjusted for clustering, we used estimates to adjust in the review. Recruitment bias: low (schools) Baseline imbalance: low (characteristics similar) Loss of clusters: low (no loss reported) Incorrect analysis: not cluster adjusted (high risk) Comparability with RCTs randomizing individuals: unclear |