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

Kotch 2003 USA.

Methods Cluster‐RCT
Allocation sequence: unclear
Allocation concealment: not stated
Blinding: open
Inclusion of participants in the analysis: unclear
Length of follow‐up: 7 months (November 2002 to May 2003)
Cluster‐adjustment method: unclear
Participants Number: 46 child‐care centres (23 intervention, 23 control) with 388 infants and toddlers
Inclusion criteria:
  1. Child expected to remain in the child‐care centre for the duration of trial and should be <36 months of age at the end of data collection and that at least one family member contact could participate in a telephone survey in English


Exclusion criteria: not stated
Age: Infants and toddlers < 36 months
Interventions Intervention (see Table 5 for detailed description):
  1. Larger training Staff of centres were trained using the Keep it clean training module


Control:
  1. No intervention but received the same equipment at the completion of the trial

Outcomes
  1. Diarrhoeal rates


Not used in this review:
  • Days child absent from child care centre per 100 child days

  • Percentage of days child ill per 100 child days

  • Percentage of days care giver absent from work as a result of illness.

Notes Location: North Carolina, America
Duration: September 2002 to May 2003
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Applied different statistical tests for different nature of variables: "No control variables are included in these descriptive comparisons".
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 "Attrition form the intervention and control groups during the course of the trial was comparable".
Selective reporting (reporting bias) Low risk None observed.
Other bias High risk "Two significant differences between the 2 trial groups were noted. The total number of children and the number of boys were larger in the intervention classrooms. These differences may have reduced the overall effect of the intervention, because number of children per classroom is a risk factor, and boys tend to stay in diapers longer. In addition, control centres were working hard to get their perceived reward (the free equipment that they were promised at the end of the trial). These 3 factors should have reduced the difference in outcomes between the intervention and control groups, suggesting that the significant differences in illnesses and absences that were found favouring the intervention group are all the more impressive".