Butz 1990 USA.
Methods | Cluster‐RCT Method of allocation sequence: unclear Allocation concealment: unclear Blinding: none Inclusion of participants in the analysis: unclear Length of follow‐up: 12 months Cluster‐adjustment method: not adjusted |
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Participants | Number: 24 family day‐care centres, with 108 children (58 intervention, 50 control) Inclusion criteria: not stated Exclusion criteria: unclear Age: 1 month to 7 years |
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Interventions | Intervention (see Table 5 for detailed description):
Control:
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Outcomes | Incidence of infectious disease symptoms (diarrhoea) | |
Notes | Location: Baltimore, Maryland, USA Duration: 12 months |
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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 | 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 | 28 children (114 children were enrolled from the FDCHs but actual number of children used in the analysis is 86). |
Selective reporting (reporting bias) | Unclear risk | Did not measure the relative contribution of each component of intervention, however "to reduce reporting bias, all day care providers were aware that the intervention program was being tested in certain homes". |
Other bias | Low risk | None observed. |