Validation of PBC-10 in Japanese patients with primary biliary cholangitis.

Background And Aim: Primary biliary cholangitis (PBC) is a chronic cholestatic liver disease that significantly impairs health-related quality of life (HRQOL). The PBC-10, a short-form HRQOL assessment tool, was developed for rapid screening in clinical settings. This study aimed to verify the reliability and validity of the Japanese version of the PBC-10 in Japanese patients with PBC.

Methods: We retrospectively analyzed HRQOL data from 496 Japanese outpatients with PBC, collected between 2015 and 2016. Reliability was assessed using Cronbach's alpha, item-total score correlations, and ceiling and floor effects. Validity was evaluated by examining correlations between PBC-10 scores and the total and subdomain scores of the Japanese version of the PBC-40, a validated PBC-specific HRQOL questionnaire.

Results: Cronbach's alpha for the PBC-10 was 0.872, demonstrating high internal consistency. Strong item-total score correlations were observed for all items. No ceiling effects were noted, but floor effects were present across all items. The PBC-10 total score showed a very strong positive correlation with the PBC-40 total score (ρ = 0.964, p < 0.001). Strong correlations were also found between most PBC-10 items and the PBC-40 subdomains, supporting validity.

Conclusion: The Japanese version of the PBC-10 is a reliable and valid tool for rapidly assessing HRQOL in Japanese PBC outpatients. It has potential utility for identifying patients who may benefit from emerging treatments targeting symptom relief.