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Hearing Disorders: HELP
Articles by Thomas Winfield
Based on 2 articles published since 2010
(Why 2 articles?)
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Between 2010 and 2020, Tom Winfield wrote the following 2 articles about Hearing Disorders.
 
+ Citations + Abstracts
1 Article Oral steroids for hearing loss associated with otitis media with effusion in children aged 2-8 years: the OSTRICH RCT. 2018

Francis, Nick A / Waldron, Cherry-Ann / Cannings-John, Rebecca / Thomas-Jones, Emma / Winfield, Thomas / Shepherd, Victoria / Harris, Debbie / Hood, Kerenza / Fitzsimmons, Deborah / Roberts, Amanda / Powell, Colin Ve / Gal, Micaela / Jones, Sarah / Butler, Christopher C. ·Division of Population Medicine, School of Medicine, Cardiff University, Cardiff, UK. · Centre for Trials Research, Cardiff University, Cardiff, UK. · College of Human and Health Sciences, Swansea University, Swansea, UK. · Cardiff & Vale University Health Board, Child Health Directorate, St David's Children Centre, Cardiff, UK. · Department of General Paediatrics, Children's Hospital for Wales, Cardiff, UK. · Involving People Network, Health and Care Research Wales, Cardiff, UK. · Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK. ·Health Technol Assess · Pubmed #30407151.

ABSTRACT: BACKGROUND: Children with hearing loss associated with otitis media with effusion (OME) are commonly managed through surgical intervention, hearing aids or watchful waiting. A safe, inexpensive, effective medical treatment would enhance treatment options. Small, poorly conducted trials have found a short-term benefit from oral steroids. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of a 7-day course of oral steroids in improving hearing at 5 weeks in children with persistent OME symptoms and current bilateral OME and hearing loss demonstrated by audiometry. DESIGN: Double-blind, individually randomised, placebo-controlled trial. SETTING: Ear, nose and throat outpatient or paediatric audiology and audiovestibular medicine clinics in Wales and England. PARTICIPANTS: Children aged 2-8 years, with symptoms of hearing loss attributable to OME for at least 3 months, a diagnosis of bilateral OME made on the day of recruitment and audiometry-confirmed hearing loss. INTERVENTIONS: A 7-day course of oral soluble prednisolone, as a single daily dose of 20 mg for children aged 2-5 years or 30 mg for 6- to 8-year-olds, or matched placebo. MAIN OUTCOME MEASURES: Acceptable hearing at 5 weeks from randomisation. Secondary outcomes comprised acceptable hearing at 6 and 12 months, tympanometry, otoscopic findings, health-care consultations related to OME and other resource use, proportion of children who had ventilation tube (grommet) surgery at 6 and 12 months, adverse effects, symptoms, functional health status, health-related quality of life, short- and longer-term cost-effectiveness. RESULTS: A total of 389 children were randomised. Satisfactory hearing at 5 weeks was achieved by 39.9% and 32.8% in the oral steroid and placebo groups, respectively (absolute difference of 7.1%, 95% confidence interval -2.8% to 16.8%; number needed to treat = 14). This difference was not statistically significant. The secondary outcomes were consistent with the picture of a small or no benefit, and we found no subgroups that achieved a meaningful benefit from oral steroids. The economic analysis showed that treatment with oral steroids was more expensive and accrued fewer quality-adjusted life-years than treatment as usual. However, the differences were small and not statistically significant, and the sensitivity analyses demonstrated large variation in the results. CONCLUSIONS: OME in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. Discussions about watchful waiting and other interventions will be enhanced by this evidence. The findings of this study suggest that any benefit from a short course of oral steroids for OME is likely to be small and of questionable clinical significance, and that the treatment is unlikely to be cost-effective and, therefore, their use cannot be recommended. FUTURE WORK: Studies exploring optimal approaches to sharing natural history data and enhancing shared decision-making are needed for this condition. TRIAL REGISTRATION: Current Controlled Trials ISRCTN49798431 and EudraCT 2012-005123-32. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in

2 Article Oral steroids for resolution of otitis media with effusion in children (OSTRICH): a double-blinded, placebo-controlled randomised trial. 2018

Francis, Nick A / Cannings-John, Rebecca / Waldron, Cherry-Ann / Thomas-Jones, Emma / Winfield, Tom / Shepherd, Victoria / Harris, Debbie / Hood, Kerenza / Fitzsimmons, Deborah / Roberts, Amanda / Powell, Colin / Gal, Micaela / Butler, Christopher C. ·Division of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, UK. Electronic address: francisna@cardiff.ac.uk. · Centre for Trials Research, College of Biomedical & Life Sciences, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, UK. · Swansea Centre for Health Economics, College of Human Health Sciences, Swansea University, Singleton Park, Swansea, UK. · Cardiff and Vale University Health Board, Child Health Directorate, St David's Children Centre, Cowbridge Road East, Cardiff, UK. · Department of General Paediatrics, Children's Hospital for Wales, Heath Park, Cardiff, UK. · Division of Population Medicine, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, UK. · Nuffield Department of Primary Care Health Sciences, University of Oxford, Radcliffe Observatory Quarter, Oxford, UK. ·Lancet · Pubmed #30152390.

ABSTRACT: BACKGROUND: Children with persistent hearing loss due to otitis media with effusion are commonly managed by surgical intervention. A safe, cheap, and effective medical treatment would enhance treatment options. Underpowered, poor-quality trials have found short-term benefit from oral steroids. We aimed to investigate whether a short course of oral steroids would achieve acceptable hearing in children with persistent otitis media with effusion and hearing loss. METHODS: In this individually randomised, parallel, double-blinded, placebo-controlled trial we recruited children aged 2-8 years with symptoms attributable to otitis media with effusion for at least 3 months and with confirmed bilateral hearing loss. Participants were recruited from 20 ear, nose, and throat (ENT), paediatric audiology, and audiovestibular medicine outpatient departments in England and Wales. Participants were randomly allocated (1:1) to sequentially numbered identical prednisolone (oral steroid) or placebo packs by use of computer-generated random permuted block sizes stratified by site and child's age. The primary outcome was audiometry-confirmed acceptable hearing at 5 weeks. All analyses were by intention to treat. This trial is registered with the ISRCTN Registry, number ISRCTN49798431. FINDINGS: Between March 20, 2014, and April 5, 2016, 1018 children were screened, of whom 389 were randomised. 200 were assigned to receive oral steroids and 189 to receive placebo. Hearing at 5 weeks was assessed in 183 children in the oral steroid group and in 180 in the placebo group. Acceptable hearing was observed in 73 (40%) children in the oral steroid group and in 59 (33%) in the placebo group (absolute difference 7% [95% CI -3 to 17], number needed to treat 14; adjusted odds ratio 1·36 [95% CI 0·88-2·11]; p=0·16). There was no evidence of any significant differences in adverse events or quality-of-life measures between the groups. INTERPRETATION: Otitis media with effusion in children with documented hearing loss and attributable symptoms for at least 3 months has a high rate of spontaneous resolution. A short course of oral prednisolone is not an effective treatment for most children aged 2-8 years with persistent otitis media with effusion, but is well tolerated. One in 14 children might achieve improved hearing but not quality of life. Discussions about watchful waiting and other interventions will be supported by this evidence. FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment programme.