HepaDisk - A new quality of life questionnaire for HCV patients.

ABSTRACT

BACKGROUND: Since most patients with hepatitis C virus (HCV) infection now receive treatment irrespective of liver disease severity, special attention to patient quality of life (QoL), including psycho-social aspects, is required. No QoL questionnaire is specific for patients with HCV. AIMS: To develop and validate a short Italian questionnaire (HepaDisk) assessing the QoL of patients affected by HCV with intuitive graphic results that is understandable by patients and physicians. METHODS: A questionnaire, drafted by a steering committee, underwent a Delphi survey. A multicenter, observational study was conducted to validate the developed HepaDisk versus other tools (CLDQ-I, SF-36, WPAIHCV), and to evaluate its correlation with disease severity in Italian patients with HCV. RESULTS: The 10-item questionnaire was validated in 214 patients. HepaDisk showed a high correlation with CLDQ overall score and WPAIHCV activity impairment (Spearman's rank correlation 0.651 and 0.595, respectively) and a lower correlation with SF-36. Strong internal consistency (Cronbach coefficient 0.912), good test-retest reliability (Pearson's correlation coefficient 0.789; 95% CI, 0.714-0.865), and responsiveness to changes among improved patients were demonstrated. CONCLUSION: HepaDisk is a reliable and user-friendly tool that can monitor disease impact on patient QoL over time, providing a visual representation easily understandable by both patients and physicians.