| Methods |
Pair‐matched cluster‐randomised, controlled trial conducted in the period 19 October 1988 to 23 May 1989 in 24 childcare centres in North Carolina, USA.
The trial tested the effects of a handwashing and environment sterilising programme on diarrhoea (data not extracted) and ARIs. Child daycare centres had to care for 30 children or less, at least 5 of whom had to be in nappies and intending to stay open for at least another 2 years. Randomisation is not described, nor are cluster coefficients reported |
| Participants |
389 children aged 3 years or less in daycare for at least 20 hours a week. There were some withdrawals but the attrition on participants is not stated, only that in the end data for 31 intervention classrooms and 36 control classrooms were available. There were 291 children aged up to 24 months and 80 over 24 months that took part. The text is very confusing as 371 seem to be the total of the number of families that took part. No denominator breakdown by arm is reported and numerators are only reported as new episodes per child‐year |
| Interventions |
Structured handwashing and environment (including surfaces, sinks, toilets and toys) disinfecting programme with waterless disinfectant scrub |
| Outcomes |
Laboratory: N/A
Effectiveness: ARI (coughing, runny nose, wheezing, sore throat or earache)
Safety: N/A |
| Notes |
Risk of bias: high (poor reporting of randomisation; outcomes; numerators and denominators)
Notes: the authors conclude that the fully adjusted RR for prevention of ARIs was 0.94 (‐2.43 to 0.66). A poorly reported study |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"Pair‐matched cluster‐randomised, controlled trial', but sequence generation not reported |
| Allocation concealment (selection bias) |
Unclear risk |
Centres were matched in pairs and then randomly allocated to either intervention or control programmes. Allocation concealment not reported. |
| Blinding (performance bias and detection bias)
All outcomes |
High risk |
Not possible (intervention was training session) |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
18 families were dropped, denominator not clear |
| Selective reporting (reporting bias) |
High risk |
Denominators not clearly reported |
