Carabin 1997 CAN.
| Methods | Cluster‐RCT Allocation sequence: day‐care centres were stratified by incidence of respiratory infections and block randomized by geographical areas Allocation concealment: unclear Blinding: none Inclusion of participants in the analysis: unclear Length of follow‐up: 6 months Cluster‐adjustment method: adjusted |
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| Participants | Number: 52 day‐care centres, with 1729 children Inclusion criteria: presence of at least 1 sandbox and 1 play area; at least 12 available toddler places Exclusion criteria: not stated Age: 18 months to 3 years |
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| Interventions | Intervention (see Table 5 for detailed description):
Control:
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| Outcomes | Diarrhoea rates | |
| Notes | Location: Quebec, Canada Duration: September 1996 to November 1997 |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated‐ block randomized. |
| 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 | 43 children lost to follow‐up (5 day care centres excluded from the analysis). |
| Selective reporting (reporting bias) | Low risk | None observed. |
| Other bias | Low risk | None observed. |