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Fortnum H, Leighton P, Smith MD, et al. 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. Southampton (UK): NIHR Journals Library; 2014 Sep. (Health Technology Assessment, No. 18.60.)

Cover of 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

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.

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Children with Down syndrome are more likely than children without Down syndrome to suffer from glue ear, which is a build-up of non-infected sticky fluid in their ear on the far side of the ear drum. This leads to hearing difficulties, which can lead to problems with language and communication. There is not much evidence to help hearing specialists to decide the best way to treat this condition in children with Down syndrome. Grommets (small tubes put in the ear drum to drain the fluid) are often very difficult to insert in children with Down syndrome because they have small ears. An alternative treatment is hearing aids (HAs) but the children often will not wear them. It would be helpful to do research to find what the best treatment is.

The best research would be a trial of different treatments, with children randomly assigned to each, to see which is better. It is not clear whether or not parents and health-care professionals would agree to the child being given a treatment by chance and so this study aimed to ask parents and professionals for their views on future research, and also looked at whether or not the new information from such a trial would be cost-effective.

Parents and professionals had concerns about giving treatment by chance and thought that a study simply following the children after their routine treatment would be best. If research is to be carried out to address these issues it should examine insertion of grommets and giving HAs to children but should not include a ‘no treatment’ option. Any study should cost < £650,000.

Copyright © Queen’s Printer and Controller of HMSO 2014. This work was produced by Fortnum et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK262572

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