| Methods |
Single‐blind, cluster‐randomised controlled trial carried around the Boston area, USA, in the period 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. There were 155 children in 14 centres allocated to the intervention arm and 137 children in 12 centres allocated 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 bi‐weekly hand hygiene educational materials over 5 months versus bi‐weekly educational material on healthy diet |
| 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 bi‐weekly phone calls to care givers
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
Notes: the authors conclude that although the rate of GI illnesses was significantly lower in the intervention group, the incidence rate ratio ‐ 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 |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Random assignments were generated by computer using a permuted‐blocks design with random block sizes." |
| Allocation concealment (selection bias) |
Low risk |
"Assignments were concealed in opaque envelopes, and centers were assigned to control or intervention groups by a study investigator as they were enrolled." |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Blinding not possible |
| 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 |
