Randomised controlled trial of the effect of ventilation tubes (grommets) on quality of life at age 1-2 years
M M Roversa, P F M Krabbeb, H Straatmanc, K Ingelsa, G-J van der Wiltb, G A Zielhuisc
a Department of
Otorhinolaryngology, University Medical Centre Nijmegen, PO Box 9101, 6500 HB Nijmegen, Netherlands, b Department of Medical Technology Assessment,
University Medical Centre Nijmegen, c Department of Epidemiology, University
Medical Centre Nijmegen
Correspondence to: Dr Rovers M.Rovers{at}mie.kun.nl
Accepted 29 August
2000
AIMS
To study the effect of
treatment with ventilation tubes on quality of life in children aged
1-2 years with persistent otitis media with effusion (OME), as
compared to watchful waiting.
METHODSMulticentre randomised
controlled trial (n = 187) with two treatment arms: ventilation tubes
and watchful waiting. Children were detected by auditory screening at
the age of 9-12 months, and were subsequently diagnosed as having
persistent (4-6 months) bilateral OME. Quality of life (TAIQOL and
Erickson scales) was measured at 0, 6, and 12 months follow up.
RESULTSThere was improvement in
quality of life, but the ventilation tube group did not improve
significantly more than the watchful waiting group. Although an attempt
has been made to identify possible subgroups that benefit more, we were
not able to find such subgroups, which might be a result of lack of
power in this study.
CONCLUSIONVentilation tubes do not
have a substantial incremental effect on the quality of life of infants
aged 1-2 years with uncomplicated persistent bilateral OME.
Keywords: otitis media with effusion; ventilation tubes; randomised controlled trial; quality of life
© 2001 by Archives of Disease in Childhood
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