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. 2015 Sep 8;2015(9):CD004265. doi: 10.1002/14651858.CD004265.pub3

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
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
Interventions Intervention (see Table 5 for detailed description):
  1. Large group training

  2. Curriculum for caregivers


Control:
  1. No intervention

Outcomes Diarrhoeal rates
Notes Location: Cumberland County, North Carolina, USA
Duration: October 1988 to May 1989
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