Core Outcome Set for Reporting Outcomes of Interventions for Velopharyngeal Dysfunction: Final Results of the COS-VPD Initiative
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
The aim of this study was to develop a core outcome set (COS) for reporting outcomes in studies examining the management of VPD
Contributors
C. de Blacam, A. L. Baylis, R. E. Kirschner, S. Smith, D. Sell, K. C. Y. Sie, H. E. Harris and D. J. A. Orr
Disease Category: Child health, Ear, nose, & throat
Disease Name: Velopharyngeal speech disorder
Age Range: 1 - 69
Sex: Either
Nature of Intervention: Any
- Clinical experts
- Consumers (caregivers)
- Consumers (patients)
- Methodologists
- Researchers
- COS for clinical trials or clinical research
- Delphi process
- Semi structured discussion
- Systematic review
Outcomes recorded in papers included in a systematic review of the literature on the topic will be identified and recorded by the steering group. The steering group will group the outcomes identified into themed areas of outcomes for presentation in the Delphi survey. A Delphi process will be carried out amongst international clinical cleft teams and their patients/ parents. The steering group will use a purposive sampling process to identify a Delphi panel of international experts with broad stakeholder representation. We aim to have 30 participants complete the full Delphi process and this will likely involve inviting higher numbers of participants until a representative panel is identified. Responses to each round of the survey will be recorded by the study coordinator (CdeB), ensuring that an adequate number of participants have completed all three rounds. The Delphi survey will be presented online and participants will be asked to score each of the outcomes listed using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) scale of 1 to 9. Consensus criteria will be specified a priori and applied to two rounds of the Delphi process.The Core Outcome Set-STAndards for Reporting (COS- STAR) Equator Network guidelines will be used for the reporting of this core outcome set.