Developmental outcomes in early compared with delayed surgery for glue ear up to age 7 years: a randomised controlled trial.

OBJECTIVES

To investigate whether early versus delayed surgery for children severely affected by otitis media with effusion (OME) results in improved performance on developmental tests up to age 7 years.

DESIGN

Follow-up of a randomised controlled trial.

SETTING

University of Bristol.

PARTICIPANTS

One hundred and eighty-two children (mean age 35 months) with persistent OME, hearing loss and speech, language or behaviour problems who were originally eligible and randomised to either early surgery or delayed surgery after a period of watchful waiting were followed-up as part of the Avon Longitudinal Study of Parents and Children (ALSPAC) at age 4 1/2 and 7-8 years.

MAIN OUTCOME MEASURES

Measures included behaviour, language, educational attainment tests, hearing, reading, cognition and coordination.

RESULTS

Of the original randomised trial, 88 of 92 of the early surgery and 74 of 90 of the watchful waiting group were still participating in ALSPAC. Analysis was by intention to treat. At age 4 1/2 years there were significant differences in teacher assessment of language (adj OR 3.45, 95% CI: 1.42-8.39) and writing (adj OR 3.74, 95% CI: 1.51-9.27), in favour of early surgery. At age 7-8 years, there was a significant difference on teacher report of emotional problems (adj OR 4.11, 95% CI: 1.15-14.64) in favour of early surgery. There were no other significant differences.

CONCLUSIONS

Early surgery for the child severely affected by OME may be associated with subtle benefits at age 4 1/2 years. This may continue to 7-8 years but the small study size makes it difficult to distinguish these effects from chance. A larger study is recommended.