title: Oral steroids for the resolution of otitis media with effusion (OME) in children (OSTRICH): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  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. 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
  A 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.
  
  
  CONCLUSIONS
  An 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.
  
  
  BACKGROUND
  
  ISRCTN49798431 (Registered 7 December 2012).
authors.affiliation: South East Wales Trials Unit, Centre for Trials Research, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XW, UK. waldronc@cardiff.ac.uk.
authors.forename: Cherry-Ann
authors.initials: CA
authors.lastname: Waldron
authors.affiliation: South East Wales Trials Unit, Centre for Trials Research, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XW, UK. Thomas-JonesE@cardiff.ac.uk.
authors.forename: Emma
authors.initials: E
authors.lastname: Thomas-Jones
authors.affiliation: South East Wales Trials Unit, Centre for Trials Research, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XW, UK. CanningsRL@cardiff.ac.uk.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Cannings-John
authors.affiliation: Centre for Trials Research, College of Biomedical & Life Sciences, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. Hoodk1@cf.ac.uk.
authors.forename: Kerenza
authors.initials: K
authors.lastname: Hood
authors.affiliation: Department of General Paediatrics, Children's Hospital for Wales, Heath Park, Cardiff, CF14 4XW, UK. PowellC7@cardiff.ac.uk.
authors.forename: Colin
authors.initials: C
authors.lastname: Powell
authors.affiliation: Cardiff and Vale University Health Board, Child Health Directorate, St David's Children Centre, Cowbridge Road East, Cardiff, CF11 9XB, UK. Amanda.Roberts3@wales.nhs.uk.
authors.forename: Amanda
authors.initials: A
authors.lastname: Roberts
authors.affiliation: Ear, Nose and Throat/Head and Neck Department, University Hospital of Wales, Heath Park, Cardiff, CF14 4XN, UK. Alun.Tomkinson@wales.nhs.uk.
authors.forename: Alun
authors.initials: A
authors.lastname: Tomkinson
authors.affiliation: College of Human Health Sciences, Swansea University, Singleton Park, Swansea, SA2 8PP, UK. D.Fitzsimmons@swansea.ac.uk.
authors.forename: Deborah
authors.initials: D
authors.lastname: Fitzsimmons
authors.affiliation: Division of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. GalM@cardiff.ac.uk.
authors.forename: Micaela
authors.initials: M
authors.lastname: Gal
authors.affiliation: South East Wales Trials Unit, Centre for Trials Research, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XW, UK. HarrisD15@cardiff.ac.uk.
authors.forename: Debbie
authors.initials: D
authors.lastname: Harris
authors.affiliation: South East Wales Trials Unit, Centre for Trials Research, Cardiff University, 7th Floor, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4XW, UK. ShepherdVL1@cardiff.ac.uk.
authors.forename: Victoria
authors.initials: V
authors.lastname: Shepherd
authors.affiliation: The Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK. christopher.butler@phc.ox.ac.uk.
authors.forename: Christopher C
authors.initials: CC
authors.lastname: Butler
authors.affiliation: Division of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK. FrancisNA@cardiff.ac.uk.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Francis
mesh_terms: D000284:Administration, Oral; D000367:Age Factors; D002648:Child; D002675:Child, Preschool; D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005260:Female; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D006309:Hearing / Q000187:drug effects*; D006312:Hearing Loss, Bilateral / Q000188:drug therapy* / Q000191:economics / Q000209:etiology / Q000503:physiopathology; D006320:Hearing Tests; D006801:Humans; D008297:Male; D010034:Otitis Media with Effusion / Q000150:complications / Q000188:drug therapy* / Q000191:economics / Q000503:physiopathology; D011239:Prednisolone / Q000008:administration & dosage* / Q000009:adverse effects / Q000191:economics; D011788:Quality of Life; D020127:Recovery of Function; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D006113:United Kingdom
chemical_list: D005938:Glucocorticoids; D011239:Prednisolone