Schwartz 1980.
Methods | Randomised, placebo‐controlled trial (patients who failed to respond at 1 week crossed over to alternative treatment) | |
Participants | 41 children aged 1.2 to 10 years seen by 2 paediatricians in separate private clinics Effusions present for at least 3 weeks despite previous antibiotics and/or decongestants Diagnosis: 1B, 2C 48% bilateral |
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Interventions | Antibiotic (sulfisoxazole) plus prednisone 1 mg/kg/day tapering over 7 days (n = 24) versus antibiotic plus placebo (n = 17) | |
Outcomes | Tympanometry and pneumo‐otoscopy clearing of effusions Follow up at 1 week after entry (data for the period after participants cross‐over have not been included) Not clear whether 'cleared' refers to clearing in all affected ears |
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Notes | Not clear why numbers in treatment groups unbalanced. Small sample size therefore likely due to chance, but the number of participants enrolled and randomised not stated. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method of sequence generation not state |
Allocation concealment (selection bias) | Low risk | Quote: "Pulverized prednisone tables or lactose powder packed in unmarked gelatin capsules and placed in identical coded vials by a registered pharmacist"; patients are assumed to have been enrolled in the clinic |
Blinding (performance bias and detection bias) All outcomes | Low risk | Unclear if outcome assessors were blind, but study reported as double‐blind |
Incomplete outcome data (attrition bias) < 1 month | Unclear risk | 41 participants included in study, but not clear if only 41 were randomised |
Incomplete outcome data (attrition bias) 1 to 6 months | Unclear risk | — |
Selective reporting (reporting bias) | Unclear risk | Poor reporting |
Other bias | Unclear risk | Baseline characteristics not reported |