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Core Outcome Set for Reporting Outcomes of Interventions for Velopharyngeal Dysfunction: Final Results of the COS-VPD

Catherine de Blacam^1,2, Adriane L Baylis^3,4, Richard E Kirschner^3,4

¹575349Department of Plastic Surgery, 11595Children's Health Ireland at Crumlin, Dublin, Ireland.

The Cleft Palate-Craniofacial Journal : Official Publication of the American Cleft Palate-Craniofacial Association

|August 16, 2021

Abstract

Objective:

To date, the recording of outcomes of interventions for velopharyngeal dysfunction (VPD) has not been standardized. This makes a comparison of results between studies challenging. The aim of this study was to develop a core outcome set (COS) for reporting outcomes in studies examining the management of VPD.

Design:

A two-round Delphi consensus process was used to develop the COS.

Patients, Participants:

The expert Delphi panel comprised patients and caregivers of patients with VPD, surgeons and speech and language therapists specializing in cleft palate, and researchers with expertise in VPD.

Interventions:

A long list of outcomes was derived from the published literature. In each round of a Delphi survey, participants were asked to score outcomes using the Grading of Recommendations, Assessment, Development, and Evaluations scale of 1 to 9, with 1 to 3 labeled "not important," 4 to 6 labeled "important but not critical," and 7 to 9 labeled "critical."

Main Outcome Measure:

Consensus criteria were specified a priori. Outcomes with a rating of 75% or more of the panel rating 7 to 9 and 25% or fewer rating 1 to 3 were included in the COS.

Results:

A total of 31 core outcomes were identified from the Delphi process. This list was condensed to combine topic areas to produce a final COS of 10 outcomes, including both processes of care and patient-reported outcomes that should be considered for reporting in future studies of VPD.

Conclusions:

Implementation of the COS-VPD will facilitate consistency of outcomes data collection and comparison of results across studies.

Keywords:

COS-VPD core outcome set outcomes patient-reported outcomes velopharyngeal dysfunction

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