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

Zhang, Peng, Ren, Jiaming, Chen, Tao ORCID: https://orcid.org/0000-0002-5489-6450, Wang, Jiajia, Li, Jiansheng and Xie, Yang (2025) 'Patient‐Reported Outcome Scale for Allergic Rhinitis (AR‐PRO): Development and Validation in China'. International Forum of Allergy & Rhinology. (In Press)

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Abstract

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.

Item Type:	Article
Subjects:	WV Otolaryngology > WV 100 General works WV Otolaryngology > Nose and Paranasal Sinuses > WV 300 General works
Faculty: Department:	Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):	https://doi.org/10.1002/alr.23521
SWORD Depositor:	JISC Pubrouter
Depositing User:	JISC Pubrouter
Date Deposited:	06 Feb 2025 14:22
Last Modified:	06 Feb 2025 14:22
URI:	https://archive.lstmed.ac.uk/id/eprint/25996

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