The study included 389 children aged 2-8 years with bilateral otitis media with effusion for ≥3 months and audiometry confirmed hearing loss in both ears, recruited from outpatient departments in England and Wales.
The study had 80% power to detect a change in the proportion of children with resolved hearing loss at 5 weeks after randomisation from 20% in the placebo group to 35% in the oral steroid group, and a 15% absolute increase in the rate of resolution at 5 weeks was considered to represent a clinically meaningful benefit (that could result in a meaningful reduction in insertion of ventilation tubes). The authors note that more children than they anticipated recovered spontaneously (33% versus 20% anticipated), raising the possibility that the study may not have been sufficiently powered to detect a difference (albeit smaller than anticipated) in the primary outcome. However there were no observed differences in functional health status or quality-of-life measures, and they say it is unlikely that the difference in hearing outcomes would have translated into meaningful advantages on these measures, even with a larger sample size.