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

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. Methods Multicentre randomised controlled trial (n = 187) with two treatmen t arms: ventilation tubes and watchful waiting. Children were detected by a uditory screening at the age of 9-12 months, and were subsequently diagnose d 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. A lthough an attempt has been made to identify possible subgroups that benefi t more, we were not able to find such subgroups, which might be a result of lack of power in this study. Conclusion-Ventilation tubes do not have a substantial incremental effect o n the quality of life of infants aged 1-2 years with uncomplicated persiste nt bilateral OME.