Luby 2003a PAK.
| Methods | Cluster‐RCT Allocation sequence: computer‐generated Allocation concealment: serially numbered Blinding: none Inclusion of participants in the analysis: unclear Length of follow‐up: 12 months Cluster‐adjustment method: adjusted |
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| Participants | Number: 36 neighbourhoods (25 intervention, 11 control), with 4691 children (3163 intervention, 1528 control) Inclusion criteria: household located in the trial area; have at least 2 children < 5 years; intention to reside in the house for the duration of trial Exclusion criteria: not stated Age: < 15 years |
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| Interventions | Intervention (see Table 5 for detailed description):
Control:
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| Outcomes | Diarrhoeal rates | |
| Notes | Location: low‐income squatter settlements, Karachi, Pakistan Duration: April 2002 to April 2003 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Adequate. |
| Allocation concealment (selection bias) | Low risk | Adequate. |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not described. |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described. |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 139 children from the intervention arm and 85 from the control arm out of the 4691 children originally enrolled were lost to follow‐up. |
| Selective reporting (reporting bias) | Low risk | None observed. |
| Other bias | Low risk | None observed. |