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

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
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
Interventions Intervention (see Table 5 for detailed description):
  1. Large group training (in‐home instruction to day‐care providers)


Control:
  1. No intervention

Outcomes Incidence of infectious disease symptoms (diarrhoea)
Notes Location: Baltimore, Maryland, USA
Duration: 12 months
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.