Validation of the Simple Cholestatic Complaints Score in Primary Sclerosing Cholangitis: A Single-Center Prospective Study

Background: Primary Sclerosing Cholangitis (PSC) is a rare, chronic, progressive cholestatic liver disease associated with symptoms that significantly impair daily functioning and quality of life, outcomes that are increasingly being evaluated in clinical trials. The Simple Cholestatic Complaints Score (SCCS) is a brief, four-item patient-reported questionnaire that assess pruritus, fatigue, right upper quadrant (RUQ) pain, and fever. It was developed specifically for patients with PSC and is currently undergoing international validation across multiple languages. Aim of the study: This study aimed to evaluate the reliability, performance and convergent validity of the SCCS in a cohort of Italian patients with PSC. Material and methods: The SCCS was prospectively administered to consecutive patients with PSC followed at Padua University Hospital between February 2025 and May 2026. Reliability was assessed through internal consistency (Cronbach's α and McDonald’s ω) and test-retest reliability in a subset of patients who completed the questionnaire twice, 48 hours apart. SCCS items were correlated with laboratory parameters and the Amsterdam-Oxford Model (AOM) score and were compared between patients with and without inflammatory bowel disease (IBD). Convergent validity was evaluated by comparison with established patient-reported outcome measures (PROMs), including the PBC-40 and a Visual Analogue Scale (VAS). Results: Ninety-four patients with PSC were enrolled (median age 45 years [IQR 32-58]; 62% male); of whom 69% had concomitant IBD. Most patients reported no pruritus (63%), fatigue (57%), or RUQ pain (66%); while fever was uncommon (4%). Internal consistency was borderline but improved after removal of the fever item (Cronbach’s α=0.61, McDonald’s ω=0.62). Test-retest reliability, assessed in 29 patients was 0.90 for the total score and exceeded 0.70 for all domains. Positive correlations with alkaline phosphatase (ALP) were observed for pruritus (ρ = 0.40, p < 0.001), fatigue (ρ = 0.21, p = 0.045). RUQ pain (ρ = 0.31, p = 0.003). RUQ pain also correlated with aspartate transaminase (AST) levels (ρ = 0.29; p = 0.005). Patients reporting fever had higher bilirubin levels, lower platelet counts, and higher AOM scores; these associations were not observed for the other SCCS items. SCCS items demonstrated convergent validity through correlations with their corresponding VAS score and PBC-40 domain. In addition, SCCS pruritus and fatigue score correlated with the PBC-40 cognitive domain. The SCCS total score did not differ between patients with-IBD and without-IBD. Conclusion: Pending internal confirmation of the ongoing international validation process, the SCCS appears to be a simple and feasible tool for symptom assessment in Italian patients with PSC. It showed meaningful associations with cholestatic biomarkers and good convergence with established PROMs. These findings support its potential role in both clinical practice and clinical trials as a valuable instrument for monitoring cholestatic symptoms in PSC.