Methods | Cluster RCT Method to adjust for clustering: primary outcome of BMI was not adjusted for clustering Cluster unit: household Average cluster size: 4 ICCs: not reported Length of follow‐up: 21 months |
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Participants | All children living in endemic area Number analysed for primary outcome: 954 households containing 855 participants Age range/mean age: Children aged 19 years and less Inclusion criteria: all household in members except those < 2 years old or pregnant Exclusion criteria: none stated |
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Interventions | Single dose vs placebo
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Outcomes |
aBMI measured in children aged 19 years and less. Not included in review: Malaria‐like symptoms questionnaire, finger prick blood test for malaria, skin prick tests, symptoms of asthma and atopic dermatitis, stool sample for Tichuris and hookworms. |
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Notes | Location: Ende district of Flores Island, Indonesia Community category: 1 Source of funding: The Royal Netherlands Academy of Arts and Science (KNAW), European, Prof. Dr. P.C. Flu Foundation. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "Random Allocation software" used. |
Allocation concealment (selection bias) | Unclear risk | No details reported. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Participants and personnel blinded. "The treatment code was concealed from trial investigators and participants. The un‐blinding of treatment codes occurred after all laboratory results had been entered into the database." Not reported whether the assessors for height and weight were blinded. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Number of children randomized was not reported. |
Selective reporting (reporting bias) | Low risk | All stated outcomes reported. |
Other bias | Low risk | Recruitment bias: low (unlikely to change households) Baseline imbalance: low (no differences apparent) Loss of clusters: low (ITT analysis done; in the albendazole arm 61 people moved to a house that was assigned to placebo while in the placebo arm 62 people moved to a house that was assigned to albendazole) Incorrect analysis: cluster adjusted (low risk) Comparability with RCTs randomizing individuals: unclear |