title: Early surgery compared with watchful waiting for glue ear and effect on language development in preschool children: a randomised trial.
abstract: BACKGROUND
  Otitis media with effusion (OME) is the most common cause of hearing loss in children and is generally treated by elective surgery. We compared in children with persistent OME the effect on speech and language development of immediate surgery (ventilation-tube insertion) and watchful waiting before surgery.
  
  
  METHODS
  We did a randomised controlled trial with masked outcome assessment in Bristol Children's Hospital, Bristol, UK. We included 186 children born between April 1, 1991, and Dec 31, 1992, who had confirmed bilateral OME and bilateral hearing impairment of 25-70 dB of at least 3 months' duration. Children were randomly assigned surgery within 6 weeks (n=92), or 9 months of watchful waiting (n=90), after which bilateral tube insertion was done if required. We assessed hearing loss, expressive language, and verbal comprehension at 9 months and 18 months.
  
  
  RESULTS
  At 9 months, standardised scores for expressive language and verbal comprehension differed between groups with marginal significance after adjustment for baseline differences (p=0.04 and p=0.028, respectively). At 9 months, verbal comprehension and expressive language skills in the watchful-waiting group were 3.24 months behind those in the early-surgery group. The watchful-waiting group was delayed on these two measures compared with their age-expected levels. 18 months after randomisation, 85% of children in the watchful-waiting group had received surgery and groups did not differ significantly.
  
  
  CONCLUSIONS
  There is some benefit from ventilation-tube insertion for expressive language and verbal comprehension but the timing of surgery is not critical.
authors.affiliation: Department of Otolaryngology, St Michaels Hospital, University of Bristol, UK.
authors.forename: R
authors.initials: R
authors.lastname: Maw
authors.forename: J
authors.initials: J
authors.lastname: Wilks
authors.forename: I
authors.initials: I
authors.lastname: Harvey
authors.forename: T J
authors.initials: TJ
authors.lastname: Peters
authors.forename: J
authors.initials: J
authors.lastname: Golding
mesh_terms: D000158:Acoustic Impedance Tests; D001301:Audiometry, Pure-Tone; D002663:Child Language; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D006311:Hearing Disorders / Q000209:etiology; D006801:Humans; D007223:Infant; D007804:Language Development; D008297:Male; D008876:Middle Ear Ventilation; D010034:Otitis Media with Effusion / Q000601:surgery* / Q000628:therapy; D013060:Speech / Q000502:physiology; D013067:Speech Perception / Q000502:physiology; D013997:Time Factors; D016896:Treatment Outcome; D014705:Verbal Behavior / Q000502:physiology