Sandora 2005.

Study characteristics
Methods	Single‐blind, cluster‐RCT carried around the Boston area, USA, in the period of November 2002 to April 2003. The trial tested the effects of using a hand sanitiser and a programme of instruction on the transmissions of GI infections (data not extracted) and ARIs in families. Units of randomisation were childcare centres and were carried out on enrolment by an investigator using random block size generated by computer. Assignment was single‐blind (i.e. investigator blinded to the status of the centre). Cluster correlation was 0.01.
Participants	292 families with 1 or more children aged 6 months to 5 years who were in child care for 10 or more hours a week 155 children in 14 centres were allocated to the intervention arm and 137 children in 12 centres to the control arm. The mean age was 3 to 2.7 years. Attrition was respectively 15 (3 lost to follow‐up and 12 who discontinued the intervention) and 19 (8 lost to follow‐up and 11 who discontinued the intervention). ITT analysis was carried out.
Interventions	Alcohol‐based hand sanitiser with biweekly hand hygiene educational materials over 5 months versus biweekly educational material on healthy diet. See Table 4 for details.
Outcomes	Effectiveness: ARI (2 of the following symptoms for 1 day or 1 of the following symptoms for 2 days: runny nose, cough, sneezing, stuffy or blocked nose, fever, sore throat). An illness episode had to be separated by 2 symptom‐free days from a previous episode. A secondary illness was when it followed a similar illness in another family member by 2 to 7 days. Follow‐up was by means of biweekly phone calls to caregivers. Safety: dry skin (71 reports), stinging (11 reports), bad smell (7 reports), dislike (2 reports), allergic reaction (2 reports), slippery feel (1 report), and irritation (20 reports).
Notes	Risk of bias: low Note: the authors conclude that although the rate of GI illnesses was significantly lower in the intervention group, the IRR was not significantly different for ARIs (0.97, 95% CI 0.72 to 1.30). Compliance and droplet route spread may account for this apparent lack of effect. A well‐reported trial. Study funds and hand sanitiser were provided by GOJO Industries, Inc (Akron, OH).  No conflict of interest declared.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Random assignments were generated by computer using a permuted‐blocks design with random block sizes."
Allocation concealment (selection bias)	Low risk	Low riskUnclear riskHigh risk
Blinding of participants and personnel (performance bias) All outcomes	High risk	Quote: "Teachers in the intervention classrooms were responsible for encouraging the use of the disinfecting wipes and hand sanitizer according to the study protocol ... Given that no placebo was provided and sanitizer use was recorded, neither families nor data collectors could be blinded as to the group assignment of the family."
Blinding of outcome assessment (detection bias) All outcomes	High risk	Quote: "Given that no placebo was provided and sanitizer use was recorded, neither families nor data collectors could be blinded as to the group assignment of the family."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Attrition was 15 in intervention arm (3 lost to follow‐up and 12 who discontinued the intervention) and 19 in the control arm (8 lost to follow‐up and 11 who discontinued the intervention). ITT analysis was carried out.
Selective reporting (reporting bias)	Unclear risk	Well‐reported