TESTING THE PERFORMANCE OF THE NEWLY DEVELOPED VERSION OF THE EQ-5D WITH 5 LEVELS OF SEVERITY: APPLICATION ON A COHORT OF PATIENTS WITH CHRONIC HEPATIC DISEASES

Scalone L(1), Ciampichini R(2), Fagiuoli S(3), Gardini I(4), Del Prete A(3), Gaeta L(3), Fusco F(2), Mantovani LG(5)

(1)University of Milano—Bicocca, Monza, Monza e Brianza, Italy; (2)Charta Foundation, Milan, Italy; (3)Ospedali Riuniti Bergamo, Bergamo, Italy; (4)EPAC—Hepatic Patient Association, Vimercate, Milan, Italy; (5)Federico II University of Naples, Naples, Italy

OBJECTIVES: To assess the performance of the EQ-5D-5L in a naturalistic context targeted to patients with hepatic diseases. Preliminary investigations suggest that the new version of EQ-5D, with five levels (5L) of severity per domain, is promising to assess individuals’ QoL more appropriately than the standard version with three levels. However, further research is encouraged to investigate the EQ-5D-5L properties in different subpopulations and contexts.

METHODS: This study was conducted within a project aimed to estimate costs and QoL related to hepatic diseases. The participants self-completed a questionnaire including the 5L descriptive system, the 3L standard descriptive system, and the VAS. The following properties were tested: feasibility (amount of missing answers); amount of inconsistent and consistent responses between 3L and 5L versions; convergent validity with the 3L version and VAS (Spearman’s rank correlation coeffi cient); discriminatory power (informativity).

RESULTS: Data from 426 patients were analyzed: 69% male, 19 to 84 (median = 57) years old. They were affected with: chronic hepatitis C (25.4%), chronic hepatitis B (22.5%), chronic hepatitis B and C (1.2%), cirrhosis (20.9%), liver transplantation (19.0%), hepatic carcinoma (4.5%), nonalcoholic steatohepatitis (1.9%), and other less frequent hepatic diseases. With the standard version (3L), patients reported some or severe problems with mobility (24.2%), self-care (10.4%), usual activities (29.0%), pain/ discomfort (35.5%), and anxiety/depression (37.4%). Median VAS was 70 (15–100). Missing answers were more frequent with the 3L version (6.6% vs. 4.0% of patients). In total, 97.5% of responses were consistent. Convergent validity of 5L-VAS (from 0.35 to −0.57) was similar to the one of 3L-VAS (from −0.41 to −0.56). 3L-5L correlation coeffi cient ranged from 0.83 to 0.91. Informativity was similar between the two versions.

CONCLUSIONS: The EQ-5D-5L version holds promise as a validextension of the standard 3L version for the assessment of QoL of individuals with hepatic diseases.