Scale evaluation
sleep disturbance, itch
The NASH-CHECK scales confirmed through CFA were evaluated to assess scale-level properties, including reliability, construct validity, and responsiveness.For multi-item scales, internal consistency reliability was assessed by Cronbach’s coefficient alpha, with an optimal range considered to be 0.70 to 0.90 [Test–retest reliability was assessed using NASH-CHECK scale scores at baseline and week 2 for two stable groups defined as (1) patients who had no change from baseline to week 2 on PGIS and (2) patients in the placebo treatment arm who had no change from baseline to week 2 on PGIS. Intraclass correlation coefficients (ICCs) were calculated using 2-way mixed-effects analysis of variance with absolute agreement for single measures [Construct validity was evaluated via convergent and divergent correlations between NASH-CHECK scale scores and scores on the supporting measures. Pearson correlations were computed between NASH-CHECK scales and VAS for itch, VAS for sleep disturbance, CLDQ scales, EQ VAS, and clinical assessments; polyserial correlations were computed between NASH-CHECK scales and PGIS. The strength of the correlations was interpreted based on Cohen’s [Responsiveness was evaluated by comparing differences (using ANOVA) in the mean change from baseline in NASH-CHECK scale scores at week 12 and week 48 between patients categorized as improved, no change, or worsened on PGIS. Responsiveness was further evaluated through correlations between changes in NASH-CHECK scale scores and changes on supporting measures.