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
ContributorsC. 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: Ear, nose, & throat
Disease Name: Velopharyngeal Dysfunction
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
Firstly, a systematic review was carried out. Based on workshop discussions at the Craniofacial Society of Great Britain & Ireland annual meeting (Birmingham UK 2018) and the Second International Symposium on VPD (Columbus, OH, USA 2018), further outcomes were added to the initial list. A Delphi process was carried out amongst international cleft teams and their patients/caregivers to achieve consensus on the outcomes to be included in the COS. 31 outcomes were generated from the delphi. The steering group considered 31 core outcomes to be quite large and potentially impractical as a COS, It was therefore
decided, in a deviation from the study protocol, to group similar or overlapping outcomes together and to report the final COS-VPD as a smaller number of outcome domains (10).