| Methods |
RCT |
| Participants |
Children at risk of AOM
Age range: 1 to 4 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) |
Low risk |
Allocation sequence was described as randomised and generated by a computer |
| Allocation concealment (selection bias) |
Low risk |
Participants and investigators enrolling participants could not foresee assignment because of sequentially numbered drug containers of identical appearance |
| 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 |
Reasons for missing outcome data are unclear but do not seem to be related to clinical motives |
| Selective reporting (reporting bias) |
Unclear risk |
The report gives insufficient information to permit judgement of adequacy or inadequacy |
| Other bias |
Low risk |
The trial appears to be free of other sources of bias |
