Title: Oral STeroids for Resolution of otitis media with effusion (OME) In CHildren: the OSTRICH study
Funder: Division for Social Care and Health Research (Wales)

Abstract: Design: Individually randomised double blind placebo controlled trial.Setting: ENT outpatient clinics.Target population: Children aged 2-8 years who have symptoms of hearing loss attributable to OME for at least three months and have been assessed in an ENT outpatient clinic and been diagnosed with having bilateral OME and have a significant hearing loss confirmed by audiology.Health Technologies Being Assessed: Oral Prednisolone at a daily dose of 1mg/kg (max. 30mg) for 7 days. This is the most commonly used dose in previous studies of treatment for OME and is at the lower end of the standard dose for the treatment of other conditions with inflammatory components (such as asthma and auto-immune inflammatory disorders).Measurement of Cost and Outcomes: Children in both trial arms will be assessed at baseline at 5 weeks (4 weeks after completing treatment) 3 months 6 months and 12 months and through completion of a self-report diary each day for the first five weeks. The primary outcome measure will be proportion of children with acceptable hearing (defined as less than 20 dBHL averaged at 0.5 1 2 and 4 kHz in at least one ear in children aged 3-8 years and less than 25 dBA averaged at 0.5 1 2 and 4 KHz by soundfield VRA in children aged under 3 years) at 5 weeks. The following secondary outcomes will be assessed through a combination of the self-report diary and questionnaires completed at each of the follow-up assessments and validated through a search of primary and secondary care health records at 12 months: •Hearing using age-appropriate audiometry•Presence of effusion (assessed by otoscopy and tympanometry);•Functional health status and symptoms resolution assessed using the OM8-30 scale and daily symptom data•Health related quality of life using EQ5D among parents as a proxy•Grommet operations•Resource use including: Medicine costs and use staff time and other inputs associated with the intervention subsequent consultations operations days off work / school and use of hearing aid.Analysis plan: The primary comparative analyses will employ logistic regression to investigate differences in the proportion of children achieving acceptable hearing at 5 weeks between the two treatment arms adjusting for study site. Secondary outcomes will be analysed using logistic regression linear regression models and time series models as appropriate. For the economic evaluation differences in costs and outcomes between groups will be computed and used in conjunction with outcomes differences to generate cost-effectiveness ratios. A series of one-way sensitivity analyses will be undertaken to assess the impact of parameter variation and a probalistic sensitivity analysis undertaken to determine the extent to which the intervention can be regarded as representing value for money.Sample size: In order to demonstrate a difference between achieving satisfactory hearing at 5 weeks after randomisation in 20% of the control group and 35% of the intervention group with an alpha of 0.05 and 80% power we will need 302 participants. In order to allow for a 20 % loss to follow up at one year we will recruit 380.


Research activity codes: 6.1 PHARMACEUTICALS
Health categories: EAR