ArticleOrphanet journal of rare diseases2025
Psychometric validation of the Worst Itch Numerical Rating Scale (WI-NRS) and other patient-reported outcome measures for assessing severity and impact of pruritus in patients with primary biliary cholangitis.
Article in Orphanet journal of rare diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02966834 (A Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis), which is not on this map. Cited by 6 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Multi-dose, Placebo-controlled Study to Evaluate the Efficacy, Safety and Tolerability of GSK2330672 Administration for the Treatment of Pruritus in Patients With Primary Biliary Cholangitis (GLIMMER: GSK2330672 triaL of IBAT Inhibition With Multidose Measurement for Evaluation of Response)
Who cites it
6 citing papers in PubMed.
- Pruritus Is Frequent and Persistent and Impacts Quality of Life Among Patients With Primary Sclerosing Cholangitis.Alimentary pharmacology & therapeutics · 2026Article
- Unravelling the Itch: Cross-Sectional Analysis of Pruritus Patterns in the PicnicHealth Primary Biliary Cholangitis Registry.Liver international : official journal of the International Association for the Study of the Liver · 2026Article
- Meaningful Improvement Thresholds for Pruritus and Sleep Disturbance in PBC Using the Worst Itch and Sleep Interference Numerical Rating Scales.Advances in therapy · 2026Article
- Primary Biliary Cholangitis in the Middle East: A Review of Current Challenges and Treatment Approaches.Cureus · 2026Review
- An Explainable AI Framework for Continuous Monitoring, Risk Stratification, and Clinical Decision Support in Primary Biliary Cholangitis: Protocol for a Multiphase Development and Validation Study.JMIR research protocols · 2026Article
- Consensus statements of the Hellenic Autoimmune Liver Diseases Study Group on the diagnosis and current management of primary biliary cholangitis.Annals of gastroenterologyArticle
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Authors and funding
10 authors.
Funding
Abstract
backgroundCholestatic 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 NRS), and fatigue (Fatigue NRS), plus the PBC-40 (modified with a 7-day recall), among patients with PBC and pruritus. METHODOLOGY: Data were analyzed from the Phase 2b GLIMMER trial (NCT02966834) of linerixibat and a separate observational study in patients with PBC and pruritus. Pruritus severity was assessed using the 0-10 WI-NRS. Psychometric properties of the WI-NRS, Sleep Interference NRS, Fatigue NRS, and PBC-40 (7-day recall) were evaluated. Additional PRO data were used to support validation analyses. Multiple psychometric methods were used to validate the NRS items and PBC-40 (7-day recall).
resultsData for 288 patients (n=147 GLIMMER; n=141 observational study) with PBC experiencing pruritus were included. The internal consistency of PBC-40 (7-day recall) was acceptable to excellent and confirmatory factor analysis confirmed its domain structure. All PBC-40 domains showed acceptable test-retest reliability (intraclass correlation coefficients [ICCs]: 0.72-0.90). The WI-NRS showed acceptable test-retest reliability (ICCs: 0.73-0.81 [GLIMMER]; ICC: 0.78 [observational study]). Test-retest reliability was also acceptable for the Sleep Interference (ICC: 0.85 [GLIMMER]; ICC: 0.77 [observational study]) and Fatigue (ICC: 0.88 [GLIMMER]; ICC: 0.78 [observational study]) NRS items. Convergent, discriminant, and known-groups validity were confirmed for all three NRS items and the PBC-40. Additionally, the NRS and PBC-40 Itch domain demonstrated responsiveness by reflecting change in other PROs over time.
conclusionsThe data support the psychometric reliability, validity, and responsiveness of WI-NRS, pruritus-related Sleep Interference NRS, and Fatigue NRS, and PBC-40 (7-day recall) in patients with PBC experiencing pruritus.
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