Performance and Validation of Chronic Liver Disease Questionnaire-Hepatitis C Version (CLDQ-HCV) in Clinical Trials of Patients with Chronic Hepatitis C

摘要

Background: The hepatitis C virus (HCV) infection has tremendous clinical, health-related quality-of-life (HRQOL), and economic burden on patients and the society. To assess the comprehensive impact of HCV infection, systematic tracking of HRQOL in patients with HCV infection is important. Objective: The aim of this study was to systematically validate an HCV-specific HRQOL instrument, the Chronic Liver Disease Questionnaire-Hepatitis C Version (CLDQ-HCV), in patients with chronic HCV infection. Methods: The CLDQ-HCV has 29 items in four domains, each scored on a Likert scale of 1-to 7. We used a large cohort of patients with HCV infection enrolled in clinical trials (N = 4142) to test internal consistency, validity, and responsiveness, and we used another cohort of untreated patients with HCV infection (N = 36) to assess test-retest reliability. Results: The CLDQ-HCV performed well in all the psychometric assessments. In particular, the Cronbach alphas ranged from 0.84 to 0.94 for the four domains. The item-to-own-dimension correlations exceeded 0.6 for 27 of the 29 items. Of the clinical and demographic parameters, the presence of cirrhosis and history of psychiatric conditions were discriminated best by the CLDQ-HCV (all P < 0.0001). The domains' correlations with similar domains of the 36-item short form health survey exceeded 0.8. The responsiveness to significant clinical outcomes such as developing treatment-induced anemia and clearance of HCV infection was notable (up to -0.70 for anemia and up to +0.85 for achieving sustained virologic response; all P < 0.0001). Test-retest reliability showed intraclass correlations of 0.84 to 0.93 between multiple administrations. Conclusions: The CLDQ-HCV is a fully validated, simple-to-administer HCVspecific instrument for patients with HCV infection that could be considered in studies of HCV-infected patients.