Butz 1990 USA.

Methods	Cluster RCT
Participants	Number: 114 children (aged 1 month to 7 years) attending 24 FDCHs Inclusion criteria: all children attending FDCHs Intervention group: 69% aged ≤ 36 months and 57% girls; control group: 62% aged ≤ 36 months and 42% girls.
Interventions	Intervention (12 FDCHs): instruction to daycare providers on modes of transmission of pathogens, instructions of handwashing, use of vinyl gloves and disposable nappy changing pads at each nappy change. Providers were instructed to dispose of gloves, disposable pads, and nappies in plastic bags and given supplies (gloves, nappy changing pads, hand rinse solution). Control (12 FDCHs): no education but received biweekly nurse visits for symptom data collection.
Outcomes	Diarrhoea longitudinal prevalence (diarrhoea symptom days/childcare days). Diarrhoea: occurrence of loose, unformed bowel movements at twice the normal frequency (infants: 1–2 stools per day; older children: 1 stool per day). Symptoms recorded daily Longitudinal prevalence of vomiting and runny nose Absence from daycare home (reasons for absenteeism not recorded)
Notes	Location: 24 FDCHs in urban Baltimore, USA Length of study: 12 months (4 January 1988 to 31 December 1988) Publication status: journal
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "FDCHs were randomly assigned to control or intervention group."
Allocation concealment (selection bias)	Unclear risk	No details
Blinding of participants and personnel (performance bias) All outcomes	High risk	Daycare providers were aware that the intervention programme was being tested in certain homes.
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Daycare providers recorded the symptoms." Comment: daycare providers not blinded.
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	10.6% of missing/absent days excluded in analysis, with no information on whether they were from intervention or control FDCHs.
Selective reporting (reporting bias)	Low risk	Reported main outcomes.
Other bias	Unclear risk	—
Similarity of baseline outcome measurements	Unclear risk	NA
Similarity of baseline characteristics	Unclear risk	NA
Adequate allocation of intervention concealment during the study	Unclear risk	NA
Adequate protection against contamination	Unclear risk	NA
Confounders adequately adjusted for in analysis/design	Unclear risk	NA
Recruitment bias	High risk	Staff were aware of which cluster were intervention and control.
Baseline imbalance	Low risk	No significant baseline imbalances.
Loss of clusters	Low risk	Only 2 clusters lost (1 control and 1 intervention) = 8.3%.
Incorrect analysis	High risk	Not adjusted for clustering in analyses.