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

Paula R Williamson¹  Kevin O’Brien²  Mohammad Owaise Sharif²  Stephanie Tierney⁴  Peter Callery⁴  Iain A Bruce³  Nicola L Harman² 

[1] Department of Biostatistics, University of Liverpool, Shelley’s Cottage, Brownlow Street, Liverpool L69 3GS, UK;The Healing Foundation Cleft and Craniofacial Clinical Research Centre supported by VTCT, School of Dentistry, University of Manchester, L5.CT.364 (Research Floor), St Mary’s Hospital Oxford Road, Manchester M13 9WL, UK;Central Manchester University Hospitals NHS Foundation Trust, Oxford Road, Manchester M13 9WL, UK;School of Nursing, Midwifery & Social Work, University of Manchester, Jean McFarlane Building, Oxford Road, Manchester M13 9PL, UK

关键词: Otitis media with effusion;    Cleft palate;    Consensus methods;    Delphi;    Core outcome set;   

Others  :  1094577
DOI  :  10.1186/1745-6215-14-70

 received in 2012-12-13, accepted in 2013-02-22,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Harman et al.; licensee BioMed Central Ltd.

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