| Methods |
Double‐blind, placebo‐controlled, cluster‐randomised trial that took place in 3 schools in California during March to April 1999. The study assessed the incremental value of using an alcohol hand rub together with water and soap handwashing. Both arms had been given an educational programme starting 2 weeks prior to the beginning of the trial. Randomisation was by classroom and the placebo hand rub was indistinguishable from the active ingredient. Details of randomisation are not given |
| Participants |
Of the 72 classes originally recruited, lack of compliance (use of supplementary product at least 3 times a day), reduced the classes to 32 (16 in both arms) with 769 participants aged 5 to 12 |
| Interventions |
Pump‐activated antiseptic hand rub with benzalkonium chloride (SAB) (Woodward Laboratories) or inert placebo that "virtually" looked the same in batches of 4 colour‐coded bottles containing both. School staff, parents and participants were blinded |
| Outcomes |
Laboratory: testing of virucidal and bactericidal activity of the active compound
Effectiveness: ARI (cough, sneezing, sinus trouble, bronchitis, fever, red eye, headache, mononucleosis, acute exacerbations of asthma)
Gastrointestinal and other illnesses (data not extracted)
Follow up and observation was carried out by classroom staff and illnesses were described by parents
Safety: 7 students dropped out because of mild sensitivity to the rub |
| Notes |
Risk of bias: high (no description of randomisation; partial reporting of outcomes, numerators and denominators)
Notes: the authors conclude that addition of the rub led to a 30% to 38% decrease of illness and absenteeism (RR for illness absence incidence 0.69, RR for absence duration 0.71). Very high attrition, unclear randomisation procedure, educational programme and use of placebo hand rub make generalisability of the results debatable. No confidence intervals reported |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
"randomised trial", but sequence generation not described |
| Allocation concealment (selection bias) |
Unclear risk |
Not described |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
Double‐blind, placebo‐controlled, cluster‐randomised trial. Randomisation was by classroom and the placebo hand rub was indistinguishable from the active ingredient |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Partial reporting of outcomes, numerators and denominators |
| Selective reporting (reporting bias) |
High risk |
Poor reporting |
