Validation of the allergic rhinitis treatment satisfaction and preference scale.

Allergic rhinitis (AR) affects 7.8% of U.S. adults and 10-30% of the population worldwide. AR symptoms (rhinorrhea, congestion, sneezing, nasal/ocular pruritus, and postnasal drainage) significantly impact sleep and reduce cognitive and emotional functioning affecting work and school productivity. Although effective, intranasal corticoid (INS) steroid delivery systems are often associated with adverse sensory attributes, affecting patient adherence and reducing efficacy. Patient satisfaction with treatment characteristics predicts adherence levels that can better inform treatment decisions. This study was designed to evaluate psychometric evidence for the self-administered Allergic Rhinitis Treatment Satisfaction and Preference (ARTSP) scale as a patient-reported outcomes measure for use in clinical research. Analytic methods included qualitative analysis of patient focus groups and psychometric analysis of scale data collected from 185 AR subjects enrolled in a randomized, 2-week, crossover, comparative U.S. clinical trial. Qualitative analysis conceptually supported nine treatment satisfaction subscales. Reliability by Cronbach alpha met accepted standards. Evidence was found for construct validity using structural equation modeling, criterion validity from correlation patterns between treatment satisfaction and health-related quality of life scales, and discriminant validity analysis based on AR symptom-defined groups. Responsiveness was shown by significant change in treatment satisfaction subscales among AR symptom change groups. Scores on treatment preference items discriminated between the aqueous and aerosol INS formulations. The ARTSP scale is a conceptually sound, reliable, valid, and responsive measure of patient evaluations of alternative therapies, providing detailed information about treatment characteristics that are likely to influence adherence levels and subsequent AR clinical control.