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ABSTRACT: Background
Cholestatic pruritus is common in primary biliary cholangitis (PBC), often leading to sleep disturbances and substantially impairing health-related quality of life (HRQoL). Fatigue, also frequent in PBC, can be exacerbated by sleep interference due to nighttime pruritus. Quantitative numerical rating scales (NRS) are appropriate for assessing unidimensional patient-reported outcome (PRO) concepts and are easily interpreted. The PBC-40 is a disease-specific, patient-derived 40-item tool that assesses HRQoL in patients with PBC. To assess pruritus severity in clinical trials, rigorous validation of PROs in the target patient population is required. This study aimed to validate the NRS items for worst itch (WI-NRS), pruritus-related sleep interference (Sleep Interference NR
SUBMITTER: Gelhorn H
PROVIDER: S-EPMC12315290 | biostudies-literature | 2025 Jul
REPOSITORIES: biostudies-literature