Patient-Reported Outcome Scale for Allergic Rhinitis (AR-PRO): Development and Validation in China

Background: Patient-reported outcomes (PROs) have become indispensable measures in allergic rhinitis (AR) clinical trials. However, there is currently no scale specifically designed for the Chinese population. This study aimed to develop and validate the patient-reported outcome scale for allergic rhinitis (AR-PRO) to provide a reliable tool for AR patients in China.

Methods: We analyzed the relevant literature and medical records, and conducted interviews and panel discussions to develop the conceptual framework and generate the item pool. We subjected the collected items to removal, mergence, or modification to form the initial scale through a qualitative review by experts and patients. Subsequently, we conducted two field surveys to select items for the final scale based on the classical test theory and item response theory (IRT). Finally, we conducted a formal survey to assess the measurement properties of the AR-PRO.

Results: The AR-PRO comprised 20 items across four domains, including physiology, psychology, environment, and satisfaction. The Cronbach's α coefficient and intraclass correlation coefficient (ICC) between two AR-PRO-based measurements were 0.910 and 0.950, respectively. The content validity, structural validity, criterion validity, and discriminant validity all met relevant standards. The item analysis results based on IRT were acceptable. Both the response rate and completion rate of the scale were 100%, and the average completion time was 380.4 ± 123.6 s.

Conclusion: The 20-item AR-PRO developed may be a reliable and scientific measure for AR clinical trials as it exhibited good reliability, validity, and feasibility.