Table 3

Grommets in OME

CitationStudy groupStudy type (level of evidence)OutcomeKey resultsComments
Rach et al (1991)n=52 Age: 2 year olds Children from a larger cohort were screened for OME with tympanograms Randomised to treatmentRandomised controlled trial (level 2b)Improvement in language scores at 6 monthsImprovement in scores in the treatment group, but large overlapping CIFollow 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 treatmentRandomised controlled trial (level 2b)Improvement in language scores at 9 and 18 monthsImprovement 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 significantFollow 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 treatmentRandomised controlled trial (level 2b)Improvement of language scores at 6 and 12 monthsNo difference between treatment and watchful waiting groupsFollow up 79% Balanced allocation for groups but groups were different for confounding factors; not clear if testers were blinded