Brooker 1992.
Methods | Randomised controlled trial (ears) | |
Participants | Unilateral or bilateral OME diagnosed by otoscopy, audiometry and tympanometry 40 children Aged 3 to 10 referred to ENT |
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Interventions | Carnival balloon 3 times a day or no treatment for 3 weeks Both groups had equal care except for the intervention |
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Outcomes | Pure‐tone audiometry
Tympanometry
(Both at 3 weeks) Parents reported "good compliance" |
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Notes | Ears Children unable to use the carnival blower excluded prior to randomisation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation by selection of envelopes (e‐mail confirmation from author 13 November 2012) |
Allocation concealment (selection bias) | Unclear risk | Sealed envelopes |
Comparability of groups at pre‐test | Unclear risk | Not stated |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition; 100% follow‐up |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |