Article Text
Therapeutics
Ventilation tubes did not improve quality of life in persistent otitis media with effusion
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QUESTION: In young children with persistent otitis media with effusion (OME), is treatment with ventilation tubes more effective than a period of watchful waiting for improving quality of life?
Design
Randomised {allocation concealed*}†, unblinded,* controlled trial with 12 months of follow up.
Setting
13 hospitals in the Netherlands.
Patients
206 children who had persistent OME confirmed by tympanometry and otoscopy. 19 children (9.2%) withdrew from the trial immediately after randomisation, leaving 187 children (mean age 19 mo) in the study sample. 176 children (85%) completed follow up.
Intervention
Patients were allocated to ventilation tubes (n=93) or watchful waiting (n=94).
Main outcome measures
Quality of life was measured using the TNO-AZL Infant …