Psychometric validation of the experience with allergic rhinitis nasal spray questionnaire

Abstract

Bruce Crawford1, Richard H Stanford2, Audrey Y Wong3, Anand A Dalal2, Martha S Bayliss11Mapi Values, Boston, MA, USA; 2GlaxoSmithKline, Research Triangle Park, NC, USA; 3BioMedical Insights, San Francisco, CA, USABackground: Patient experience and preference are critical factors influencing compliance in patients with allergic rhinitis (AR) receiving intranasal corticosteroids. The Experience with Allergic Rhinitis Nasal Spray Questionnaire (EARNS-Q) was developed to measure subject experiences with and preferences for nasal sprays.Objective: To describe the psychometric validation of the EARNS-Q modules.Methods: An observational study was conducted with subjects aged 18–65 years with physician-diagnosed vasomotor, seasonal, and/or perennial allergic rhinitis who were using a prescription nasal spray. Subjects completed the experience module of the EARNS-Q and the Treatment Satisfaction Questionnaire with Medication (TSQM) at baseline and after 2 weeks. Further validation analyses were conducted in a 3-week, randomized, single-blind, crossover, multicenter clinical study in which subjects ≥18 years of age with documented seasonal AR received flunisolide and beclomethasone and completed the EARNS-Q experience module on days 1 and 8, the EARNS-Q preference module on day 22, and the TSQM on days 8 and 22.Results: The observational and clinical studies were completed by 121 and 89 subjects, respectively. Both modules demonstrated acceptable reliability (α = 0.72 experience module; α = 0.93 preference module global scores) and validity (intraclass correlation coefficient or ICC 0.64 to 0.82 test–retest validity). Correlations among the experience and preference modules were moderate (r = 0.39 to 0.79) and within internal consistency reliability estimates, indicating measurement of distinct constructs.Conclusion: The EARNS-Q is a patient-reported outcomes measure that enables reliable and valid measurement of subject experience with, and preference for, prescription intranasal corticosteroid sprays for allergic rhinitis.Keywords: EARNS-Q, allergic rhinitis, compliance, intranasal corticosteroid, patient preference, psychometric validation