Awasthi 1995 (Cluster)

Methods	Cluster‐quasi‐RCT Method to adjust for clustering: cluster used as unit of analysis Cluster unit: urban slum Average cluster size: 74 ICCs: not reported. Length of follow‐up: 2 years
Participants	All children living in endemic area Number analysed for primary outcome: 50 slums randomized containing 3712 children Age range: 1 to 4 years Inclusion criteria: children aged 1 to 4 from 50 urban slums in Lucknow selected on the basis of geographic convenience Exclusion criteria: none stated
Interventions	Multiple doses vs placebo Albendazole plus placebo: 400 mg albendazole plus 2 mL vitamin A every 6 months; Placebo: 2 mL vitamin A every 6 months.
Outcomes	Mean change in weight post‐treatment Mean change in height post‐treatment
Notes	Location: Lucknow, India Community category: 3 Trial carried out in 1995 and published in 2008. Source of funding: Clinical Trial Service Unit (CTSU), University of Oxford, United Kingdom, and co‐funded by the International Clinical Epidemiology Network Inc., Philadelphia, United States of America. Albendazole was donated by SmithKline Beecham (now GlaxoSmithKline).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Quasi‐randomized: "Random allocation was done by SA, listing the anganwadi centers of each slum area serially in alphabetical order, numbering them from 1 to 50, and then generating a single random number by computer that allocated either all odd or all even numbers to a specific intervention type"
Allocation concealment (selection bias)	High risk	Not concealed.
Blinding (performance bias and detection bias) All outcomes	High risk	Cluster‐RCT with health staff and participants knowing which group they were allocated to.
Incomplete outcome data (attrition bias) All outcomes	Low risk	1852/1968 children in the treatment group completed all follow‐up visits; 1860/1967 children in the usual care group completed all follow‐up visits. Inclusion of all randomized participants (number evaluable/number randomized): 94% (3712/3935).
Selective reporting (reporting bias)	Low risk	All stated outcomes reported.
Other bias	Low risk	Recruitment bias: unclear (Not known if children shift clinics in the light of the intervention) Baseline imbalance: unclear Loss of clusters: low (none reported) Incorrect analysis: cluster adjusted (low risk) Comparability with RCTs randomizing individuals: unclear