Abstract
BackgroundOtitis media with effusion (OME) is an accumulation of fluid in the middle ear affecting about 80 % of children by the age of 4 years. While OME usually resolves spontaneously, it can affect speech, behaviour and development. Children with persistent hearing loss associated with OME are usually offered hearing aids or insertion of ventilation tubes through the tympanic membrane. Oral steroids may be a safe and effective treatment for OME, which could be delivered in primary care. Treatment with oral steroids has the potential to benefit large numbers of children and reduce the burden of care on them and on health services. However, previous trials have either been too small with too short a follow-up period, or of too poor quality to give a definite answer.The aim of the Oral Steroids for the Resolution of Otitis Media with Effusion in Children (OSTRICH) trial is to determine if a short course of oral steroids improves the hearing of children with OME in the short and longer term.Methods/designA total of 380 participants (children of 2 to 8 years of age) are recruited from Hospital Ear, Nose and Throat departments in Wales and England. A trained clinician seeks informed consent from parents of children with symptoms for at least 3 months that are attributable to OME and with confirmed bilateral hearing loss at study entry. Participants are randomised to a course of oral steroid or a matched placebo for 1 week. Outcomes include audiometry, tympanometry and otoscopy assessments; symptoms; adverse effects; functional health status; quality of life; resource use; and cost effectiveness. Participants are followed up at 5 weeks, and at 6 and 12 months after the day of randomisation. The primary outcome is audiometry-confirmed satisfactory hearing at 5 weeks.DiscussionAn important evidence gap exists regarding the clinical and cost effectiveness of short courses of oral steroid treatment for OME. Identifying an effective, safe, nonsurgical intervention for OME in children for use in primary care would be of great benefit to children, their families and the NHS.Trial registrationISRCTN: ISRCTN49798431 (Registered 7 December 2012)
Highlights
Otitis media with effusion (OME) is an accumulation of fluid in the middle ear affecting about 80 % of children by the age of 4 years
Identifying an effective, safe, nonsurgical intervention for OME in children for use in primary care would be of great benefit to children, their families and the National Health Service (NHS)
Audiometry confirming hearing loss of more than 20 decibel hearing level (dBHL) averaged within the frequencies of 0.5, 1, 2, and 4 KHz in both ears by pure tone audiometry (PTA) ear-specific insert, visual reinforcement audiometry (VRA) or ear specific play audiometry, or hearing loss of more than 25 dBHL averaged within the frequencies of 0.5, 1, 2, and 4 KHz by sound-field VRA or sound-field performance/play audiometry in the better hearing ear, on the day of recruitment or within the preceding 14 days
Summary
OSTRICH will be the first adequately powered trial to evaluate the clinical and cost-effectiveness of a short course of oral steroids for the resolution of OME in children in the short term and longer term. If shown to be effective, the use of oral steroids for OME could benefit children and provide the option of primary care treatment as opposed to costly secondary care. Costs for the NHS may be lowered if the number of grommet operations that are needed is reduced This will provide additional important information to healthcare providers and funders to aid them in making the most efficient use of their finite resources. If shown not to be clinically effective, that information will provide evidence to change practice where they are currently being used, and research efforts could focus on developing alternative pathways for improving the management of OME in children. The OSTRICH trial will address the important evidence gap regarding clinical and cost effectiveness of short courses of oral steroid treatment for OME. All authors listed provided critical review and final approval of the manuscript
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