Kotch 1989 USA.
| Methods | Cluster‐RCT Allocation sequence: unclear Allocation concealment unclear Blinding: participants and assessors blinded Inclusion of participants in the analysis: unclear Length of follow‐up: 7 months Cluster‐adjustment method: adjusted |
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| Participants | Number: 24 day‐care centres, with 389 classrooms Inclusion criteria: children < 3 years; present in the day care at least 20 hour per week; absence of chronic illness or medication that would predispose to infection; youngest of potentially eligible children in the same family; consenting English‐speaking parents with access a telephone; intending to remain in day‐care centre throughout trial Exclusion criteria: not stated Age: < 3 years |
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| Interventions | Intervention (see Table 5 for detailed description):
Control:
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| Outcomes | Diarrhoeal rates | |
| Notes | Location: Cumberland County, North Carolina, USA Duration: October 1988 to May 1989 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described. |
| Allocation concealment (selection bias) | Unclear risk | Not described. |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | " specifically, parental illness reports were blind to the intervention status of their children's DCCs, potential confounders were controlled for and effect modifiers were examined". |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors were blinded. |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 18 children dropped, 1 day care centre withdrew from the trial. |
| Selective reporting (reporting bias) | Unclear risk | Unclear. |
| Other bias | Unclear risk | Unclear |