Alderman 2006 (Cluster)

Methods	Cluster‐RCT Method to adjust for clustering: Not adjusted Cluster unit: parish Average cluster size: 560 ICCs: not reported but calculated from adjusted and unadjusted figures to be 0.01. Length of follow‐up: 3 years
Participants	All children living in endemic area Number analysed for primary outcome: 48 parishes randomized containing 27,995 children Age range: 1 to 7 years Inclusion criteria: children aged 1 to 7 in 50 parishes in Uganda selected by the government on the basis that around 60% of children aged 5 to 10 years in these parishes were infected with intestinal nematodes Exclusion criteria: sick children
Interventions	Multiple dose vs no treatment Albendazole: 400 mg tablet (Zentel, GSK) every 6 months, although in the event a year elapsed between the first and second treatment round; given in conjunction with a child health package including vaccinations, vitamin A, and health promotion; Child health package including vaccinations, vitamin A, and health promotion.
Outcomes	Mean change in weight post‐treatment.
Notes	Location: Uganda Community category: 2 Weight gain data taking into account the effects of cluster randomization provided by the author. Source of funding: the nutrition and early child development project, government of Uganda, the Institute of Public Health and the research committee of the World Bank.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Coin toss "The randomization was done by a member of the research team (HA) by assigning numbers to all of the parishes and converting these to base two and then determining which of the parishes were to be in the treatment by coin flips".
Allocation concealment (selection bias)	Unclear risk	No details reported.
Blinding (performance bias and detection bias) All outcomes	High risk	None. "It was not possible for us to carry out a double blind trial because of the scale of the programme and because we aimed to assess the effectiveness of giving albendazole […] during standard child health days without any trial specific inputs".
Incomplete outcome data (attrition bias) All outcomes	High risk	75% (27,995/37,165) of randomized participants were evaluated.
Selective reporting (reporting bias)	Low risk	All stated outcomes reported.
Other bias	Low risk	Recruitment bias: low risk Baseline imbalance: characteristics similar (low risk) Loss of clusters: nil (low risk) Incorrect analysis: primary outcome in paper not adjusted for clustering (personal communication Harold Alderman), but Cochrane Review adjusts this (low risk) Comparability with RCTs randomizing individuals: unclear