Awasthi 2001 (Cluster)

Methods	Cluster‐RCT Method to adjust for clustering: cluster used as unit of analysis. Cluster unit: urban slums Average cluster size: 13.5 ICCs: not reported. Length of follow‐up: 1.5 years
Participants	All children living in endemic area Number analysed for primary outcome: 124 slums randomized containing 1672 children Age range/ mean age: 0.8 years Inclusion criteria: clusters selected if they had functional community workers in slum areas of Lucknow; within each cluster, children recruited if aged between 0.5 and 1 year, on basis of survey register held by each worker of their particular area Exclusion criteria: none stated
Interventions	Multiple doses vs placebo Albendazole plus placebo: albendazole suspension (concentration not stated) (Zentel, SZB) every 6 months and 100,000 units of vitamin A every 6 months Placebo: 100,000 units of vitamin A every 6 months
Outcomes	Mean weight post‐treatment Mean change in weight post‐treatment Mean height post‐treatment Mean change in height post‐treatment (not used due to question over quoted standard error) Not included in review: stool smear for Ascaris prevalence on a subsample of the group; death rates
Notes	Location: Lucknow, India Community category: 3 Means of cluster means used in analysis. The results (weight gain) in the abstract differ from the text. Source of funding: International Clinical Epidemiological Network (INCLEN) Inc, USA and Clinical Trials Unit (CTSU), Oxford, UK.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Cluster‐randomized trial, no further details.
Allocation concealment (selection bias)	Unclear risk	No details reported.
Blinding (performance bias and detection bias) All outcomes	Unclear risk	No details reported.
Incomplete outcome data (attrition bias) All outcomes	Low risk	Intention‐to‐treat (ITT) analysis; 13.9% lost to follow‐up in albendazole group and 16.2% in the placebo group. Inclusion of all randomized participants (number evaluable/number randomized): 83% (1672/2010).
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: characteristics similar (low risk) Loss of clusters: no loss reported (low risk) Incorrect analysis: cluster adjusted (low risk) Comparability with RCTs randomizing individuals: low