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

Abstract

Aims-To study the eVect of treatment with ventilation tubes on quality of life in children aged 1-2 years with persistent otitis media with eVusion (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. Conclusion-Ventilation tubes do not have a substantial incremental eVect on the quality of life of infants aged 1-2 years with uncomplicated persistent bilateral OME. (Arch Dis Child 2001;84:45-49) Keywords: otitis media with eVusion; ventilation tubes; randomised controlled trial; quality of life Otitis media with eVusion (OME), common in childhood, is usually associated with mild to moderate hearing loss. Over the past three decades, much research has been done into the eVects of OME on children's development. 1Several studies showed impaired developmental outcomes, but others failed to show such associations.

Health-related quality of life in children with otitis media

“…Furthermore, caregivers of children with persistent bilateral OME randomized to a watchful waiting approach reported slightly more problems regarding communication, motor functioning, problem behaviour, and sleeping as well as than parents of children randomized to insertion of ventilation tubes. Besides, the parent-child interaction scores in children with persistent OME were also slightly poorer than had been observed in children without disease [41].…”

“…The manual search and expert discussion yielded one extra article [28]. After applying the criteria for inclusion and exclusion, only 13 articles remained for inclusion [29,30,[35][36][37][38][39][40][41][42][43][44]. In addition, we included results regarding reliability and validity of the TAIQOL from our own work published in a thesis [45].…”

“…The setting of the studies varied, eight studies were part of a multi-centre trial [28,35,37,38,41,[43][44][45]. Most study-populations consisted of children with chronic or recurrent otitis media ( Table 2).…”

“…The definitions of chronic and recurrent OM regarding number of OM episodes and duration, however, varied considerably. Chronic OME was defined as middle ear effusion in one or both ears for 6 weeks [36] to 6 months [41], rAOM as three or more episodes in previous 6 months [36,38,43] or more than three [29,45] to five [42] episodes within last year. Age of the patients ranged from 0 to 13 years of age.…”

Effect of Pneumococcal Vaccination on Quality of Life in Children With Recurrent Acute Otitis Media: A Randomized, Controlled Trial

“…In particular, several studies have been published investigating the effect of tympanostomy tube placement on their FHS, with some showing a positive effect 5,45,48,49 and others not. 50 Trials on tympanostomy tube placement, however, are hampered by the inability to blind caregivers and children for treatment, which means that treatment effects may be at least in part biased by their expectations.…”