A core outcome set for patient-reported dysphagia for use in head and neck cancer clinical trials: An international multistakeholder Delphi study.
Head Neck
; 46(4): 831-848, 2024 04.
Article
em En
| MEDLINE
| ID: mdl-38204219
ABSTRACT
BACKGROUND:
Measuring dysphagia-related patient-reported outcomes (PROs) in Head and Neck Cancer (HNC) patients is challenging due to dysphagia's multidimensional impact, causing inconsistency in outcome reporting. To address this issue, this study derived a consensus-based core outcome set (COS) for patient-reported dysphagia in HNC clinical trials where swallowing is a primary or secondary endpoint.METHODS:
A sample of HNC clinicians, researchers, patients, and caregivers participated in a 2-Round Delphi technique. A Delphi survey, containing a comprehensive list of dysphagia-related PROs, was developed. In Round 1, participants rated item importance on a 5-point scale. Items rated ≥4 by >70% advanced to Round 2, where a consensus meeting addressed items with varied opinions, and the Delphi survey with remaining items was completed. Items rated ≥4 by >70% formed the final COS.RESULTS:
Forty-five participants from nine countries were recruited. After Round 1, 40 items were excluded and 64 advanced to Round 2. After Round 2, a 7-outcome COS was established, comprising the domains of dysphagia symptoms, health status and quality of life.CONCLUSION:
This study achieved consensus among HNC stakeholders on essential dysphagia PROs for HNC clinical trials. It is advisable to include these 7-core concepts in clinical trials involving people with HNC to facilitate treatment comparisons and data synthesis.Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Transtornos de Deglutição
/
Neoplasias de Cabeça e Pescoço
Limite:
Humans
Idioma:
En
Revista:
Head Neck
Assunto da revista:
NEOPLASIAS
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Canadá