Hoberman 1997.
| Methods | Multicentre, randomised, non‐placebo‐controlled trial conducted at 4 university‐affiliated hospitals and 20 private practices in the US and Canada between January and July 1994 AOM was defined as either presence of purulent otorrhoea for less than 24 hours or evidence of middle ear effusion in addition to at least 1 indicator of acute middle ear inflammation Investigators were blinded to treatment assignments and participants, parents and guardians were asked not to discuss medications or duration of treatment with investigators |
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| Participants | 575 children aged 2 months to 12 years were included (287 and 288 in the 2 and 3 times daily groups, respectively) | |
| Interventions | 10 days of amoxicillin/clavulanate 40/10 mg/kg/day 2 times daily versus 45/6.4 mg/kg/day 3 times daily | |
| Outcomes | Primary outcome 1. Clinical cure rate at the end of therapy (days 7 to 15) ‐ Clinical cure (completely/improved symptoms and signs of AOM at days 12 to 14 Secondary outcomes 1. Clinical cure rate during therapy (days 2 to 3), in terms of resolution of otalgia and resolution of fever: not accounted 2. Clinical cure rate at post‐treatment (1 to 3 months): clinical cure at days 31 to 38 3. AOM complications after completion of therapy: recurrent AOM 4. Adverse reactions to medication ‐ Adverse events: diaper rash: vomiting, diarrhoea Other outcome ‐ Compliance rate |
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| Notes | Supported by SmithKline Beecham Pharmaceuticals | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "assigned randomly" Comment: method of randomisation was not mentioned |
| Allocation concealment (selection bias) | Unclear risk | Quote: "Investigators were blinded to treatment assignments" Comment: no information on the allocation concealment |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "..parents and guardians were asked not to discuss medications or duration of treatment with investigators" Comment: probably done |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | All important outcomes were accounted for |
| Other bias | Low risk | Quote: "Comparable demographic data and compliance rate" |