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. 2019 Sep 11;2019(9):CD000371. doi: 10.1002/14651858.CD000371.pub7

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
Burden: low
Trial carried out in 1995 and published in 2008.
Source of funding: Clinical Trial Service Unit (CTSU), University of Oxford, UK, and co‐funded by the International Clinical Epidemiology Network Inc., Philadelphia, USA. Albendazole was donated by SmithKline Beecham (now GlaxoSmithKline).
For the analysis of Awasthi 1995 (Cluster) we took weight from the publication by Awasthi in 2008; height data from INCLEN 1995 monograph (references contained in the main reference). Means of cluster means were used in analysis; details of correspondence from previous review suggest that trial was ongoing; data for 3‐year follow‐up are provided from R. Dickson's correspondence with the author for the Dickson 2000a Cochrane Review, but the loss to follow‐up is very high: only 24% analysed.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quasi‐randomized: Quote: "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 participants who were randomized within clusters (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