ArticlesEarly surgery compared with watchful waiting for glue ear and effect on language development in preschool children: a randomised trial
Introduction
Persistent otitis media with effusion (OME), or glue ear, is the most common cause of hearing loss during childhood, and the most frequent cause for elective surgery in children. Persistent hearing loss of 25–30 dB hearing level for more than 3 months in both ears associated with symptoms has been suggested as an appropriate indication for surgery.1 In the short term, the hearing deficit due to effusion in the middle ear is correctable by insertion of a ventilation tube. In the longer term, hearing gain after ventilation-tube insertion is not maintained. OME most frequently occurs between the ages of 1 year and 4 years and coincides with a period of rapid language acquisition. OME has, therefore, been suggested to have short-term or long-term effects on speech acquisition in young children.2 Studies of the effects of OME on speech and language development have been flawed by design difficulties such as population selection,.3, 4 failure to confirm the duration and severity or laterality of the OME, use of retrospective design, and inadequate sample size.
Moreover, the range and depth of tests of speech and language development used in trials hinder comparisons.5 Therefore, although growing evidence supports the hypothesis that the temporary hearing loss which accompanies chronic OME may be associated with speech and language delay in many children,6 confirmation is yet to be reported.7, 8 We did a randomised controlled trial to compare the effects of early surgery with watchful waiting of persistent OME on language development.
Section snippets
Patients
At baseline, children were seen in community clinics and confirmed to have bilateral OME (bilateral type B or C2 tympanograms and hearing loss of 25–70 dB hearing level, n=186). 3 months later, children were referred to consultant-run otolaryngology clinics. At this appointment we recruited children into our study. Inclusion criteria were: date of birth between April 1, 1991 and Dec 31, 1992; confirmation of bilateral OME by otoscopy and tympanometry; assessment of hearing loss; and disruptions
Results
182 children entered the study. Between randomisation and 9-month follow-up, eight (4·4%) children in the watchful-waiting group withdrew at parental request and four (2·2%) were excluded because of severe learning difficulties related to late diagnosis of syndromic disorders. Of the 16 children assigned watchful waiting who had surgery early, six children were referred for surgery by the consultant otolaryngologist or the parents opted for private surgery, and ten were admitted, unknown to the
Discussion
We designed our trial to overcome many of the shortcomings of previous studies.12, 13 Persistence of the middle-ear disorder for at least 3 months before randomisation had been confirmed objectively with tympanometry. Our study was randomised and included a watchful-waiting group, 85% of whom were judged to require surgery by the end of monitoring. We found a slight effect of OME on verbal comprehension, and a moderate delay in expressive language at 9 months in the watchful-waiting group
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