Randomised controlled trial of the effect of ventilation tubes (grommets) on quality of life at age 1-2 years.
OBJECTIVE
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.


METHODS
Multicentre 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.


RESULTS
There 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.


CONCLUSIONS
Ventilation tubes do not have a substantial incremental effect on the quality of life of infants aged 1-2 years with uncomplicated persistent bilateral OME.
Rovers
M M
MM
Department of Otorhinolaryngology, University Medical Centre Nijmegen, PO Box 9101, 6500 HB Nijmegen, Netherlands.
Krabbe
P F
PF
Straatman
H
H
Ingels
K
K
van der Wilt GJ
Zielhuis
G A
GA
D002675:Child, Preschool; D005500:Follow-Up Studies; D006305:Health Status Indicators; D006801:Humans; D007223:Infant; D008876:Middle Ear Ventilation; D015999:Multivariate Analysis; D010034:Otitis Media with Effusion / Q000534:rehabilitation / Q000601:surgery*; D011788:Quality of Life; D016896:Treatment Outcome