Development and Application of the Chinese (Mainland) Version of Chronic Liver Disease Questionnaire to Assess the Health-Related Quality of Life (HRQoL) in Patients with Chronic Hepatitis B

OBJECTIVE: To develop the Chinese (Mainland) version of Chronic Liver Disease Questionnaire (CLDQ) and use it to assess the health-related quality of life (HRQoL) of chronic hepatitis B (CHB) patients in China and identify the determinants of HRQoL. METHODS: The Chinese (Mainland) CLDQ was developed by expert consultation, focus group interviews with patients, and pilot study. The final version of questionnaire was adopted to assess the HRQoL of chronic hepatitis B outpatients enrolled from two largest infectious hospitals in Beijing. Cronbach’ s alpha was used to measure the internal consistency reliability. The construct validity was measured by factor analysis. T-test, one-way analysis of variance (ANOVA), and multi-variable linear regression were used to analyze the data. RESULTS: Cronbach’s alpha of the overall CLDQ is 0.935, ranging from 0.628 to o.881 among six subscales. Six factors were identified via factor analysis, including a new factor sleeping(SL). A total of 519 patients with CHB were included in the investigation with the final version of questionnaire, 405 of them were only with CHB, 53 with compensated cirrhosis, and 61 with decompensated cirrhosis. The CHB group scored the highest in the overall score of CLDQ (p<0.05). The score of worry (WO) domain was significantly lower in the compensated group than the CHB group (p<0.05). Decompensated cirrhosis patients scored lower than the CHB group in all CLDQ domains and the overall score (p<0.05). Stages of illness, gender, regular visits to specialized hospitals, and work status in last year were determinants of HRQoL. CONCLUSION: The psychometric properties of the Chinese(Mainland) CLDQ is acceptable. The HRQoL of CHB patients deteriorated with disease progression. Advanced stages of CHB, female, long time absence from work after illness, and no job or retirement were determinants of poor HRQoL. Regular visits to specialized hospitals was a positive determinant of HRQoL.