| Methods |
RCT |
| Participants |
Children at risk of AOM
Age range: 3 months to 3 years of age |
| Interventions |
Amoxicillin/clavulanic acid or placebo |
| Outcomes |
Otitis |
| Notes |
Children at risk of AOM |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
The trial was described as randomised but information about the randomisation process was insufficient to permit judgement of adequacy or inadequacy |
| Allocation concealment (selection bias) |
Unclear risk |
The trial was described as randomised but the method used to conceal the allocation was not described |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
The trial was described as double‐blind, but the method of blinding was not described |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
The trial was described as double‐blind, but the method of blinding was not described |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Missing outcome data are balanced in numbers across the groups |
| Selective reporting (reporting bias) |
Unclear risk |
There is insufficient information to permit judgement of adequacy or inadequacy |
| Other bias |
Unclear risk |
A pharmaceutical company prepared the placebo syrup used in the trial |
