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. 2020 Aug 13;10(8):e036824.
doi: 10.1136/bmjopen-2020-036824.

Protocol for the development of a core outcome set for reporting outcomes of management of velopharyngeal dysfunction

Catherine de Blacam  1   2 , Adriane L Baylis  3   4 , Richard E Kirschner  3   4 , Susan M Smith  5 , Debbie Sell  6 , Kathleen C Y Sie  7 , Helen E Harris  8 , David J A Orr  9   10
Affiliations

Protocol for the development of a core outcome set for reporting outcomes of management of velopharyngeal dysfunction

Catherine de Blacam et al. BMJ Open. .

Abstract

Introduction: Velopharyngeal dysfunction (VPD) is present in up to 40% of patients following cleft palate repair. Children with VPD display hypernasal speech, nasal air emission and are at a high risk for developing articulation disorders. The overall result is decreased intelligibility and acceptability of speech, as well as significant functional and social impairments. Although there are several surgical approaches for the management of children with VPD, standard treatment protocols have not been well defined. There is a need for a core outcome set (COS) to reduce outcome reporting bias and heterogeneity across studies of VPD. The COS-VPD Initiative is an international effort to establish a COS for the reporting of studies of the management of VPD.

Methods and analysis: The study has been developed according to the Core Outcome Set-STAandards for Development standards for the design of a COS study and will be carried out according to the guidance of the Core Outcome Measures in Effectiveness Trials (COMET) initiative. A long list of clinical and patient-reported outcomes will be identified from a systematic review of the literature. A two-stage Delphi consensus process will be used to refine this list into a COS. An international panel of key stakeholders including patients, parents and multidisciplinary clinical and academic experts will be invited to participate in this process. Consensus criteria will be specified a priori and the steering group will ratify the final COS.

Ethics and dissemination: The study has ethical approval through Children's Health Ireland at Crumlin Research and Ethics Committee, Ref: GEN/683/18. The study is registered with the COMET Initiative (http://www.cometinitiative.org/studies/details/1146?result=true). The COS will be disseminated by publication in the peer-reviewed literature, presentation at international research meetings and distribution to patient-representative organisations. This will facilitate the application of the COS in future studies of the management of VPD.

Keywords: paediatric plastic & reconstructive surgery; plastic & reconstructive surgery; speech pathology.

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Conflict of interest statement

Competing interests: None declared.

References

    1. Kummer A. Resonance disorders and velopharyngeal dysfunction (VPD) : Kummer A, Cleft palate and craniofacial anomalies: effects on speech and resonance. 3rd edn NY, USA: Delamar, 2014: 182–224.
    1. Bhuskute A, Skirko JR, Roth C, et al. . Association of velopharyngeal insufficiency with quality of life and patient-reported outcomes after speech surgery. JAMA Facial Plast Surg 2017;19:406–12. 10.1001/jamafacial.2017.0639 - DOI - PMC - PubMed
    1. Sell D, Grunwell P, Mildinhall S, et al. . Cleft lip and palate care in the United Kingdom--the Clinical Standards Advisory Group (CSAG) study. Part 3: speech outcomes. Cleft Palate Craniofac J 2001;38:30–7. 10.1597/1545-1569(2001)038<0030:CLAPCI>2.0.CO;2 - DOI - PubMed
    1. Cable BB, Canady JW, Karnell MP, et al. . Pharyngeal flap surgery: long-term outcomes at the University of Iowa. Plast Reconstr Surg 2004;113:475–8. 10.1097/01.PRS.0000100806.45065.35 - DOI - PubMed
    1. Britton L, Albery L, Bowden M, et al. . A cross-sectional cohort study of speech in five-year-olds with cleft palate +/- lip to support development of national audit standards: benchmarking speech standards in the United Kingdom. Cleft Palate Craniofac J 2014;51:431–51. 10.1597/13-121 - DOI - PubMed

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