Psychometric evaluation of the Dysphagia Symptom Questionnaire for adults and adolescents with eosinophilic esophagitis.

Background: Eosinophilic esophagitis (EoE) is a chronic, inflammatory disease of the esophagus leading to symptoms of esophageal dysfunction; dysphagia is the most common symptom experienced by adults and adolescents.
Objective: We sought to perform a psychometric evaluation of the Dysphagia Symptom Questionnaire (DSQ), a patient-reported outcome measure for patients with EoE.
Methods: Using baseline and week 24 data from the randomized, interventional, multinational phase 3 R668-EE-1774 trial (NCT03633617), the measurement properties of the DSQ-including reliability, construct and known-groups validity, responsiveness, and interpretation of change-were evaluated.
Results: The analysis population comprised 239 patients with EoE (age [mean ± SD], 28.1 ± 13.14 years; 63.6% male; 90.4% White). Intraclass correlation coefficients of 0.92 and 0.97 exceeded the acceptable reliability threshold (≥0.70). Construct validity correlations with EoE symptom and impact measures were moderate at baseline (| r | = 0.44-0.55) and week 24 (| r | = 0.55-0.69), and the DSQ biweekly total score discriminated among groups defined by disease severity. Analyses exploring interpretation of change from baseline on the DSQ biweekly total score indicated thresholds for within-patient improvement ranging from 9 to 23 points; a within-patient improvement from baseline of 13 points or greater could be considered clinically meaningful.
Conclusions: This analysis confirmed that the DSQ has acceptable distributional properties, test-retest reliability, construct validity, and ability to detect change. Therefore, the DSQ is a valid and reliable measure to assess the patient-reported symptom of dysphagia among adult and adolescent patients with EoE in the context of a clinical trial setting.
Competing Interests: Regeneron Pharmaceuticals, Inc, and Sanofi Global provided the financial support for the study. RTI Health Solutions, an independent nonprofit research organization, received funding under a research contract with Regeneron Pharmaceuticals, Inc, and Sanofi Global to conduct this study and provide publication support in the form of manuscript writing, styling, and submission. Disclosure of potential conflict of interest: E. S. Dellon has received research funding from Adare/Ellodi, 10.13039/100030947Allakos, Arena/Pfizer, AstraZeneca, 10.13039/100004330GlaxoSmithKline, Meritage, Miraca, Nutricia, Celgene/Receptos/BMS, Regeneron, Revolo, and Shire/Takeda; is a consultant for Abbott, AbbVie, Adare/Ellodi, Aimmune, Akesobio, Alfasigma, ALK, Allakos, Amgen, Aqilion, Arena/Pfizer, Aslan, AstraZeneca, Avir, Biorasi, Calypso, Celgene/Receptos/BMS, Celldex, Eli Lilly, EsoCap, 10.13039/501100024061Eupraxia, 10.13039/501100003122Ferring, 10.13039/100004330GlaxoSmithKline, Gossamer Bio, Holoclara, Invea, Knightpoint, Landos, LucidDx, Morphic, Nexstone Immunology, 10.13039/100031219Nutricia, 10.13039/100016751Parexel/Calyx, Phathom, 10.13039/100009857Regeneron, Revolo, Robarts/Alimentiv, Salix, 10.13039/100004339Sanofi, 10.13039/100007343Shire/Takeda, Target RWE, and Upstream Bio; and has received educational grants from Allakos, Holoclara, and Invea. K. A. Peterson is a consultant or advisor for AGA, Alladapt, AstraZeneca, Allakos, Bristol Meyers Squibb, Ellodi, Invea, Lucid, Nexstone, Peerview, Regeneron, Takeda, and WebMD; has received research fees from AstraZeneca, Allakos, Adare, Regeneron-Sanofi, Revolo, repSpeaker, AGA, Regeneron, Peerview, Takeda, and WebMD; has received unrestricted grant support from Allakos and Chobani; and has equity in Nexeos Bio. D. Whalley and S. Qin are employees of RTI Health Solutions. S. T. Tilton is an employee of Sanofi Global and may hold stocks and/or shares in the company. E. McCann, S. Kamat, and X. Sun are employees of Regeneron Pharmaceuticals, Inc, and may hold shares and/or stock options in the company.
(© 2024 The Authors.)