Roberts 2000.
Study characteristics | ||
Methods | Open cluster‐RCT carried out between March and November 1996 (the Southern Hemisphere winter season) in 23 childcare 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 hand‐washing 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 | Hand‐washing 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. See Table 4 for details. | |
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)
Note: 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 statistically 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 due to 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. This work was supported by a grant from the Commonwealth Department of Family Services and Health, Research and Development Scheme. Conflict of interest: none to report. |
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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 of participants and personnel (performance bias) All outcomes | High risk | It was not possible to blind the intervention. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The observer was not informed of the content of the training sessions or the intervention status of the centres." |
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 were comparable at baseline. |