PSYCHOMETRIC VALIDATION OF THE DYSPHAGIA SYMPTOM QUESTIONNAIRE IN EOSINOPHILIC ESOPHAGITIS PATIENTS TREATED WITH ORAL BUDESONIDE SUSPENSION
Author(s)
Hudgens S1, Evans C2, Philips E3, Hill M3
1Clinical Outcomes Solutions, Tucson, AZ, USA, 2Endpoint Outcomes, Boston, MA, USA, 3Meritage Pharma Inc., San Diego, CA, USA
OBJECTIVES: Eosinophilic Esophagitis (EoE) is an inflammatory disorder that can have an impact on quality of life in individuals. The psychometric properties of the Dysphagia Symptom Questionnaire (DSQ) were assessed in a Phase 2, randomized, double-blind, placebo controlled study of oral budesonide suspension with an open-label extension program. METHODS: The evaluation focused on three items of the DSQ. Psychometric data were analyzed against the FDA guidance and included item level analysis as well as score validation including floor/ceiling, item discrimination, construct validity (concurrent validity and known group’s method), test-retest reliability, responsiveness, and calculation of minimally important differences (MID). RESULTS: Patients were 69% male, 62% age ≥18, 95% white. Test-retest reliability was strong (r=0.82). Floor/ceiling levels were below the criteria (≤9%) for all items (range 6.5-8.6%). There was strong item discrimination with 98.1% of patients indicating dysphagia in the quartile of DSQ scores. Physician’s global ratings of severity and EoE symptom scores were consistent with monotonically increasing DSQ scores. Anchor-based MIDs were 6.5 “a little better” and 13.5 “better” respectively. CONCLUSIONS: The DSQ is a reliable and valid measure able to clinically discriminate patients along the continuum of dysphagia severity.
Conference/Value in Health Info
2015-05, ISPOR 2015, Philadelphia, PA, USA
Value in Health, Vol. 18, No. 3 (May 2015)
Code
PGI28
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Gastrointestinal Disorders