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Therapeutics
Ventilation tubes did not improve quality of life in persistent otitis media with effusion

https://doi.org/10.1136/ebm.6.4.121

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    (2001) Arch Dis Child 84, 45. Rovers MM, Krabbe PF, Straatman H, et al.. Randomised controlled trial of the effect of ventilation tubes (grommets) on quality of life at age 1-2 years.. Jan;. :. –9..
    OpenUrlAbstract/FREE Full Text

    
 
 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 …

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    Footnotes

    • Source of funding: Dutch Investigative Medicine Fund of the National Health Insurance Board.

    • For correspondence: Dr M M Rovers, Department of Otorhinolaryngology, University Medical Centre Nijmegen, PO Box 9101, 6500 HB Nijmegen, the Netherlands. m.rovers{at}mie.kun.nl.

    • ↵* See glossary.

    • ↵† Information provided by author.