Abstract: 【Abstract】Objective To assess the reliability and validity of the Chinese version of chronic urticaria quality of life questionnaire （CU-Q2oL）. Methods The original English version of CU-Q2oL was translated into Chinese after forward-backward translation and cultural adaption, and items of the Chinese version of CU-Q2oL were determined. From January to December 2019, 195 chronic spontaneous urticaria patients with or without chronic inducible urticaria were enrolled from Department of Dermatology and Venereology, Peking University First Hospital, and followed up every 2 weeks. A total of 2 follow-ups were carried out, and a questionnaire survey was conducted by using the Chinese version of CU-Q2oL, dermatology life quality index （DLQI） and urticaria activity score over 7 days （UAS7） during each follow-up. After each follow-up, the treatment protocol for each patient was adjusted by clinicians based on the patient′s condition. The number of questionnaire factors was extracted by exploratory factor analysis, convergent validity was estimated by analyzing correlations of CU-Q2oL with DLQI and UAS, and the internal consistency reliability of CU-Q2oL was evaluated by calculating Cronbach′s α coefficient; the sensitivity of CU-Q2oL was assessed by analyzing correlations of changes in UAS7 scores with changes in CU-Q2oL scores. Results Four factors were extracted from the Chinese version of CU-Q2oL, namely "symptoms", "daily functional activities", "sleep problems" and "restrictions" factors. There were 23 items in total, and the cumulative variance contribution rate was 74.011%. The Cronbach′s α coefficient of all items in CU-Q2oL was 0.961, and the Cronbach′s α coefficient of the 4 factors ranged from 0.804 to 0.933, suggesting excellent internal consistency. The total score of CU-Q2oL was moderately correlated with DLQI and UAS7 scores, with correlation coefficients of 0.437 and 0.560, respectively （both P < 0.01）. A total of 71 patients completed the second follow-up. The change in the total score of CU-Q2oL was moderately correlated with that in the UAS7 score, with a correlation coefficient of 0.392 （P < 0.01）. Conclusion The Chinese version of CU-Q2oL has excellent internal consistency, good reliability and validity, and can be used to evaluate the quality of life of patients with chronic spontaneous urticaria in China.

Key words: Urticaria, Quality of life, Sickness impact profile, Chronic spontaneous urticaria, Reliability, Validity