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A mother brings her 2 year old daughter to your clinic. She is concerned about her speech which she feels is poor for her age. Her daughter has failed two consecutive audiograms. On otoscopy she has signs of bilateral otitis media with effusion (OME) which you have confirmed on a previous occasion two months ago. Should you refer for insertion of grommets?
Structured clinical question
In preschool children with OME (glue ear) [patient] does the insertion of ventilation tubes (grommets) [intervention] as opposed to watchful waiting [comparison] have an effect on language development …
Table 3 Grommets in OME
Citation Study group Study type (level of evidence) Outcome Key results Comments
Rach et al (1991) n=52 Age: 2 year olds Children from a larger cohort were screened for OME with tympanograms Randomised to treatment Randomised controlled trial (level 2b) Improvement in language scores at 6 months Improvement in scores in the treatment group, but large overlapping CI Follow up 100%; small numbers in trial and follow up time not sufficient Balanced randomisation Testers not blinded Maw et al (1999) n=182 Age: 2–3 year olds Confirmed to have OME and hearing loss with tympanograms; only those with problems in speech, learning, or behaviour were included Randomised to treatment Randomised controlled trial (level 2b) Improvement in language scores at 9 and 18 months Improvement in treated group at 9 months Mean difference between groups was not significant 0.31 (-0.03 to 0.66) 95% CI At 18 months smaller differences which were not significant Follow up 83% Large drop out in trial makes results difficult to interpret; by 18 months 85% of watchful waiting group had grommets inserted Data analysed by intention to treat Rovers et al (2000) n=187 Age: 16–24 months From a larger cohort that were screened for hearing loss and OME Randomised to treatment Randomised controlled trial (level 2b) Improvement of language scores at 6 and 12 months No difference between treatment and watchful waiting groups Follow up 79% Balanced allocation for groups but groups were different for confounding factors; not clear if testers were blinded
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