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Patient-Reported Outcome Scale for Allergic Rhinitis (AR-PRO): Development and Validation in China
Peng Zhang1,2, Jiaming Ren1,2, Tao Chen3,4
1Department of Respiratory Diseases, The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, China.
International Forum of Allergy & Rhinology
|January 6, 2025
Summary
A new patient-reported outcome scale for allergic rhinitis (AR-PRO) was developed for Chinese patients. This 20-item scale demonstrates strong reliability and validity for use in clinical trials.
Area of Science:
- Allergy and Immunology
- Clinical Trial Methodology
- Psychometrics
Background:
- Patient-reported outcomes (PROs) are crucial in allergic rhinitis (AR) research.
- No existing PRO scale is tailored for the Chinese population.
Purpose of the Study:
- To develop and validate the Allergic Rhinitis Patient-Reported Outcome (AR-PRO) scale.
- To provide a reliable tool for AR patients in China.
Main Methods:
- Literature review, interviews, and expert/patient feedback for item generation.
- Classical test theory and item response theory (IRT) for item selection.
- Formal survey to assess measurement properties.
Main Results:
- The 20-item AR-PRO covers physiology, psychology, environment, and satisfaction.
- High reliability (Cronbach's α = 0.910, ICC = 0.950) and validity confirmed.
- Excellent feasibility with 100% response/completion rates.
Conclusions:
- The AR-PRO is a reliable, scientific, and feasible measure for AR clinical trials in China.
- The scale demonstrates good psychometric properties.
