Abstract
OSTRICH is a randomised controlled trial for otitis media with effusion (OME) in children, to determine the clinical and cost effectiveness of a short course of oral steroids. The aim is to describe and evaluate factors that have contributed to lower than expected recruitment rates.
Highlights
Introduction and aimsOSTRICH is a randomised controlled trial for otitis media with effusion (OME) in children, to determine the clinical and cost effectiveness of a short course of oral steroids
Challenges faced to recruitment include the fluctuating and seasonal nature of OME, bringing together of two separate clinical services (Audiology and ENT), limited capacity for additional appointments for follow ups, and the efficiency of children’s hospitals in terms of grommet surgery waiting times
Improvement in recruitment is due to opening more sites, continuous liaison with site staff and research nurses, and facilitating recruitment as much as possible by revisiting inclusion criteria and extending the time window for audiology confirmed hearing loss
Summary
Introduction and aimsOSTRICH is a randomised controlled trial for otitis media with effusion (OME) in children, to determine the clinical and cost effectiveness of a short course of oral steroids. Recruitment to oral steroids for the resolution of otitis media with effusion in children (OSTRICH) study: challenges of a randomised controlled trial in secondary care sites across Wales and England Cherry-Ann Waldron1*, Emma Thomas-Jones1, Debbie Harris1, Vicky Shepherd1, Rebecca Cannings-John1, Kerry Hood1, Nick Francis2, Chris Butler2,3
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