The importance of integration of stakeholder views in core outcome set development: Otitis Media with Effusion in children with cleft palate

Parfect, Victoria H.; Hall, Per N.; Bennett, Alex M.D.; Kirkham, Jamie J.; Bruce, Iain A.; Harman, Nicola L.; Williamson, Paula R.; Harman, Nicola; Bruce, Iain; Kirkham, Jamie; Tierney, Stephanie; Callery, Peter; O'Brien, Kevin; Bennett, Alex; Chorbachi, Raouf; Hall, Per; Harding-Bell, Anne; Parfect, Victoria; Rumsey, Nichola; Sell, Debbie; Sharma, Ravi; Williamson, Paula

Abstract

© 2015 Harman et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Background: Approximately 75% of children with cleft palate (CP) have Otitis Media with Effusion (OME) histories. Evidence for the effective management of OME in these children is lacking. The inconsistency in outcome measurement in previous studies has led to a call for the development of a Core Outcome Set (COS). Despite the increase in the number of published COS, involvement of patients in the COS development process, and methods to integrate the views of patients and health professionals, to date have been limited. Methods and Findings: A list of outcomes measured in previous research was identified through reviewing the literature. Opinion on the importance of each of these outcomes was then sought from key stakeholders: Ear, Nose and Throat (ENT) surgeons, audiologists, cleft surgeons, speech and language therapists, specialist cleft nurses, psychologists, parents and children. The opinion of health professionals was sought in a three round Delphi survey where participants were asked to score each outcome using a bespoke online system. Parents and children were also asked to score outcomes in a survey and provided an in-depth insight into having OME through semi-structured interviews. The results of the Delphi survey, interviews and parent/patient survey were brought together in a final consensus meeting with representation from all stakeholders. A final set of eleven outcomes reached the definition of "consensus in" to form the recommended COS: hearing; chronic otitis media (COM); OME; receptive language skills; speech development; psycho social development; acute otitis media (AOM); cholesteatoma; side effects of treatment; listening skills; otalgia. Conclusions: We have produced a recommendation about the outcomes that should be measured, as a minimum, in studies of the management of OME in children with CP. The development process included input from key stakeholders and used novel methodology to integrate the opinion of healthcare professionals, parents and children.

• Journal Article Type: Article
• Publication Date: Jun 26, 2015
• Deposit Date: Aug 12, 2015
• Publicly Available Date: Feb 18, 2016
• Journal: PLoS ONE
• Electronic ISSN: 1932-6203
• Publisher: Public Library of Science
• Peer Reviewed: Peer Reviewed
• Volume: 10
• Issue: 6
• DOI: https://doi.org/10.1371/journal.pone.0129514
• Keywords: otitis media, cleft palate, children, visible difference
• Public URL: https://uwe-repository.worktribe.com/output/832454
• Publisher URL: http://dx.doi.org/10.1371/journal.pone.0129514
• Contract Date: Feb 18, 2016