Randomised controlled trial of early surgery versus watchful waiting for glue ear: the effect on behavioural problems in pre-school children

This trial was designed to compare early surgery with watchful waiting for persistent bilateral otitis media with effusion (OME) in terms of hearing l oss and behavioural problems in pre-school children. A randomised controlle d trial compared the effects of early treatment with ventilation tubes vers us watchful waiting for 9 months. Results were analysed by intention-to-tre at. One hundred and eighty-two pre-school children (date of birth between 1 April 1991 and 31 December 1992), mean age of 2.9 years (SD 0.85) with at least a 3-month history of bilateral OME and hearing loss of greater than 2 5 dB were treated in Bristol Children's Hospital between November 1993 and January 1996. Bilateral ventilation tubes were inserted within 6 weeks of r andomisation or within 6 weeks of reassessment after 9 months of watchful w aiting, with a final assessment at 18 months. The main outcome measures wer e behavioural problems, measured by the Richman Behaviour Checklist, and he aring loss at 4000 Hz in the better hearing ear. Early surgical interventio n significantly reduced behavioural problems by 17% (95% CI, 2%-33%). This difference was largely mediated by concurrent hearing loss. After 18 months , there was no longer a significant difference (95% CI, - 19% to + 10%). Ho wever, the majority (85%) of the Watchful Waiting group had required surger y and 22% of all children still had behavioural problems.