{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T23:37:02Z","timestamp":1791589022601,"version":"4.3.4"},"reference-count":82,"publisher":"National Institute for Health and Care Research","issue":"60","license":[{"start":{"date-parts":[[2014,9,1]],"date-time":"2014-09-01T00:00:00Z","timestamp":1409529600000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000276","name":"National Institute for Health Research","doi-asserted-by":"publisher","award":["09\/166\/01"],"award-info":[{"award-number":["09\/166\/01"]}],"id":[{"id":"10.13039\/501100000276","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:sec id=\"abs1-1\"><jats:title>Background<\/jats:title><jats:p>There is clinical uncertainty of the benefits and costs of different treatment options for children with Down syndrome who have glue ear. This study was designed to assess the extent of this lack of knowledge and determine if pursuing further information would be practical, beneficial and cost-effective.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-2\"><jats:title>Objectives<\/jats:title><jats:p>To assess the level and practical effect of current uncertainty around treatment options for children with Down syndrome and glue ear. To assess the feasibility of studying the options for management of glue ear in children with Down syndrome via a randomised controlled trial (RCT) or multicentre prospective cohort study by evaluating the willingness of (1) parents to agree to randomisation for their children and (2) clinicians to recruit participants to a definitive study. To undertake value of information analyses to demonstrate the potential economic benefit from undertaking further research.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-3\"><jats:title>Design<\/jats:title><jats:p>A feasibility study exploring the views of parents of children with Down syndrome and professionals who have responsibility for the health and education of children with Down syndrome, on the participation in, and value of, future research into interventions for glue ear. Data were collected from parents via self-completed questionnaires, face-to-face interviews and focus groups and from professionals via online questionnaires and a Delphi review exercise. Development of economic models to represent clinical pathways of care and a RCT informed a value of information (VOI) analysis.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-4\"><jats:title>Setting<\/jats:title><jats:p>UK (professionals); East Midlands region of the UK (parents).<\/jats:p><\/jats:sec><jats:sec id=\"abs1-5\"><jats:title>Participants<\/jats:title><jats:p>Parents of children aged 1\u201311 years with Down syndrome (<jats:italic>n<\/jats:italic>\u2009=\u2009156). Professionals including audiologists, ear, nose and throat surgeons, audiological physicians, speech and language therapists, and teachers of the deaf (<jats:italic>n<\/jats:italic>\u2009=\u2009128).<\/jats:p><\/jats:sec><jats:sec id=\"abs1-6\"><jats:title>Main outcome measures<\/jats:title><jats:p>Quantitative and qualitative data on parental views and experiences of glue ear and its effects; interventions and treatment received; taking part in research and factors that would encourage or discourage participation; and the importance of various outcome domains to them and for their children. For professionals: information on caseloads; approaches to clinical management; opinions on frequency and significance of the consequences of glue ear for this population; importance of different outcome measures; opinions of interventions and their role in future research; views on health research; facilitators and barriers to recruitment, and participation in research involving RCTs.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-7\"><jats:title>Results<\/jats:title><jats:p>The complexity of the experience and individual characteristics of children with Down syndrome poses challenges for the design of any future research but these challenges were not considered by professionals to raise sufficient barriers to prevent it being undertaken. Parents were generally supportive of the need for, and value of, research but identified practical and emotional issues that would need addressing. Glue ear was considered to impact more on speech, language and communication than on hearing. Outcome measures for future research would need to evaluate these elements but measures should be designed specifically for the population. Parents and professionals identified randomisation as a significant barrier to participation. The VOI analyses identified lack of data as problematic but concluded that a future trial involving surgical intervention would be feasible at costs of &lt;\u2009\u00a3650,000.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-8\"><jats:title>Conclusions<\/jats:title><jats:p>Future research into the benefits of interventions for glue ear in children with Down syndrome would be feasible and could be cost-effective but should be carefully designed to facilitate and maximise participation from parents and professionals responsible for recruitment.<\/jats:p><\/jats:sec><jats:sec id=\"abs1-9\"><jats:title>Funding<\/jats:title><jats:p>The National Institute for Health Research Health Technology Assessment programme.<\/jats:p><\/jats:sec>","DOI":"10.3310\/hta18600","type":"journal-article","created":{"date-parts":[[2014,10,2]],"date-time":"2014-10-02T07:33:16Z","timestamp":1412235196000},"page":"1-148","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":14,"title":["Assessment of the feasibility and clinical value of further research to evaluate the management options for children with Down syndrome and otitis media with effusion: a feasibility study"],"prefix":"10.3310","volume":"18","author":[{"given":"Heather","family":"Fortnum","sequence":"first","affiliation":[{"name":"National Institute for Health Research, Nottingham Hearing Biomedical Research Unit, Nottingham, UK"},{"name":"School of Medicine, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul","family":"Leighton","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Murray D","family":"Smith","sequence":"additional","affiliation":[{"name":"School of Pharmacy, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"Brown","sequence":"additional","affiliation":[{"name":"National Institute for Health Research, Nottingham Hearing Biomedical Research Unit, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Jones","sequence":"additional","affiliation":[{"name":"School of Medicine, University of Nottingham, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claire","family":"Benton","sequence":"additional","affiliation":[{"name":"Nottingham University Hospitals NHS Trust, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth","family":"Marder","sequence":"additional","affiliation":[{"name":"Nottingham University Hospitals NHS Trust, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew","family":"Marshall","sequence":"additional","affiliation":[{"name":"Nottingham University Hospitals NHS Trust, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kate","family":"Sutton","sequence":"additional","affiliation":[{"name":"Nottinghamshire Healthcare, County Health Partnerships, Nottingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"6221","published-online":{"date-parts":[[2014,9]]},"reference":[{"key":"key20141001092241919_ref1-bib1","doi-asserted-by":"crossref","first-page":"S44","DOI":"10.5694\/j.1326-5377.2009.tb02926.x","article-title":"Otitis media: viruses, bacteria, biofilms and 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