| Methods |
Open cluster‐RCT carried out between March and November 1996 (the southern hemisphere winter season) in 23 child care centres caring for a minimum of 50 children 10 hours a day, 5 days a week in Australia. The study assessed the effects of an Australian national handwashing programme compared to standard procedure. Randomisation was according to a random number table and cluster coefficients are reported |
| Participants |
Children (299 in the intervention arm and 259 in the control arm) aged 3 or younger attending the centres at least 3 days a week. Attrition was 51 children in the intervention arm and 72 children in the control arm due mainly to staff leaving the centres |
| Interventions |
Handwashing programme with training for staff and children. It is unclear whether any extra hand cleansing agents were used, as GloGerm (?) is mentioned when it was used in a preliminary study |
| Outcomes |
Laboratory: N/A
Effectiveness: ARI (runny nose, cough and blocked nose)
Follow up was via a parental phone interview every 2 weeks
Safety: N/A |
| Notes |
Risk of bias: low (cluster coefficients and analysis by unit of randomisation)
Notes: the authors conclude that although there was no overall decrease in respiratory illness (RR 0.95, 95% CI 0.89 to 1.01), in children up to 24 months the decrease was significant (RR 0.90, 95% CI 0.83 to 0.97). The authors speculated that this was because maximum benefits are likely from this age group because of their limited ability to wipe their nose and hands without a structured programme. Analyses by 3 compliance levels are also reported. A so‐so reported and well‐conducted trial |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Randomisation was according to a random number table |
| Allocation concealment (selection bias) |
Unclear risk |
Not reported |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Not possible to blind the intervention |
| Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Recruitment rate 88% (23 of 26 CCCs); loss to follow up not clear as no denominator given |
| Selective reporting (reporting bias) |
Low risk |
Centres comparable at baseline |
