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MOMENT – Management of Otitis Media with Effusion in Cleft Palate : protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey

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Harman, Nicola L., Bruce, Iain A., Callery, Peter, Tierney, Stephanie, Sharif, Mohammad Owaise, O’Brien, Kevin and Williamson, Paula R. (2013) MOMENT – Management of Otitis Media with Effusion in Cleft Palate : protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. Trials, 14 (1). 70. doi:10.1186/1745-6215-14-70

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Official URL: http://dx.doi.org/10.1186/1745-6215-14-70

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Abstract

Background:
Cleft palate (CP) has an incidence of approximately 1 in 700. Children with CP are also susceptible to otitis media with effusion (OME), with approximately 90% experiencing nontrivial OME. There are several approaches to the management of OME in children with CP. The Management of Otitis Media with Effusion in Children with Cleft Palate (MOMENT) study is a feasibility study that includes the development of a core outcome set for use in future trials of the management of OME in children with CP.

Methods/Design:
The MOMENT study will include a systematic review of the literature to identify a list of outcomes that have previously been reported. This list of outcomes will be used in a Delphi study with cleft clinicians. The Delphi study is anticipated to include three rounds. The first round will ask clinicians to score the outcome list and to add any outcomes they think are relevant. The second round involves presentation of scores according to stakeholder group and the opportunity for participants to rescore outcomes. To ensure that the opinion of parents and children are sought, qualitative interviews will be completed with a purposive sample in parallel. In the final round of the Delphi process, participants will be shown the distribution of scores, for each outcome, for all stakeholder groups separately as well as a summary of the results concerning outcomes from the qualitative interviews with parents. A final consensus meeting will be held with all stakeholders, including parents and children, to review outcomes.

Discussion:
A core outcome set represents the minimum that should be measured in a clinical trial for a particular condition. The MOMENT study will aim to identify a core outcome set that can be used in future trials of the management of OME, improving the consistency of research in this clinical area.

Item Type: Journal Article
Subjects: R Medicine > RD Surgery
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School > Health Sciences > Warwick Research in Nursing > Royal College of Nursing Research Institute (RCN) (- July 2017)
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Cleft palate., Otitis media with effusion., Otitis media with effusion in children ., Otitis media in children.
Journal or Publication Title: Trials
Publisher: BioMed Central Ltd.
ISSN: 1745-6215
Official Date: 12 March 2013
Dates:
DateEvent
12 March 2013Published
22 February 2013Accepted
Volume: 14
Number: 1
Article Number: 70
DOI: 10.1186/1745-6215-14-70
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
Funder: National Institute for Health Research (Great Britain). Technology Assessment Programme (NIHR TAP)
Grant number: 09/167/02
Adapted As: Received: 13 December 2012Accepted: 22 February 2013Published: 12 March 2013

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