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Development and validation of a hepatitis B‐specific health‐related quality‐of‐life instrument: CLDQ‐HBV
Author(s) -
Younossi Zobair M.,
Stepanova Maria,
Younossi Issah,
Racila Andrei
Publication year - 2021
Publication title -
journal of viral hepatitis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.329
H-Index - 100
eISSN - 1365-2893
pISSN - 1352-0504
DOI - 10.1111/jvh.13451
Subject(s) - medicine , hepatitis b virus , cronbach's alpha , hepatitis b , worry , cirrhosis , quality of life (healthcare) , clinical psychology , psychiatry , psychometrics , immunology , virus , anxiety , nursing
Abstract Hepatitis B virus (HBV) carries a large global burden. Efforts abound to decrease the burden, which necessitates reporting of patient‐reported outcomes (PROs). We aimed to develop and validate an HBV‐specific PRO instrument using the Chronic Liver Disease Questionnaire (CLDQ). Data were obtained from patients enrolled in our HBV registries who completed the CLDQ, Short Form‐36 (SF‐36) and FACIT‐F. The sample was split randomly 1:1 into training and testing groups. A standard PRO instrument validation pipeline was used to develop and validate the new CLDQ‐HBV instrument. HBV patients (n = 1,339) were 48 ± 13 years old, 60% male, 8% cirrhosis, with 53% receiving oral antivirals (OAV). After reduction of 10 redundant items, exploratory factor analysis for the remaining 19 items found 95% of variance was explained by five factors—emotional function, fatigue, systemic symptoms, worry and sleep. Good‐to‐excellent internal consistency was found: Cronbach's alphas 0.70‐0.90 and item‐to‐own‐domain correlations >0.50 for 18/19 items. Known‐group validity tests discriminated between HBV patients with and without cirrhosis, with FIB‐4 ≥ 3.25 vs <3.25, with and without history of depression or clinically overt fatigue (all p < 0.0001), and treatment (all p < 0.05, all but one <0.0001). After 48‐week follow‐up, HBV patients receiving OAV (N = 144) with ≥2.7 log 10/mL decline in HBV viral load experienced significant improvements in fatigue, worry and total CLDQ‐HBV scores ( p < 0.05). The newly developed CLDQ‐HBV is a short, disease‐specific PRO instrument for HBV patients which was developed and validated using large data set and an established methodology showing excellent psychometric characteristics.