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. 2025 Jun;45(6):e70118.
doi: 10.1111/liv.70118.

Quality Measures to Enhance the Management and Treatment of Primary Biliary Cholangitis: A Delphi Consensus Study

Domenico Alvaro  1 , Vincenza Calvaruso  2 , Marco Carbone  3 , Nora Cazzagon  4 , Annarosa Floreani  5   6 , Pietro Invernizzi  7   8 , Marco Marzioni  9 , Patrizio Pasqualetti  10 , Grazia Pennisi  2 , Pierluigi Toniutto  11 , Umberto Vespasiani-Gentilucci  12   13 , Antonio Craxì  2
Affiliations

Quality Measures to Enhance the Management and Treatment of Primary Biliary Cholangitis: A Delphi Consensus Study

Domenico Alvaro et al. Liver Int. 2025 Jun.

Abstract

Background & aims: Primary Biliary Cholangitis (PBC) is a chronic autoimmune liver disease characterised by bile duct destruction, leading to cholestasis and fibrosis. Despite therapeutic advancements, gaps remain in diagnostic standardisation, treatment response evaluation, and patient-centred care. This study aimed to develop consensus-driven quality measures to optimise PBC management.

Methods: Using the Delphi methodology, 92 clinicians participated in two rounds of surveys addressing diagnostic protocols, therapeutic strategies, follow-up standards, and patient-reported outcomes (PROs). Appropriateness ratings were analysed using the RAND/UCLA method to achieve consensus on key quality measures.

Results: Strong consensus was reached on the appropriateness of non-invasive diagnostic tools such as Vibration-Controlled Transient Elastography (VCTE) and abdominal ultrasound for staging and monitoring fibrosis in chronic cholestasis. Different treatment options were evaluated in patients with inadequate response to UDCA, including compensated cirrhosis (Child-Pugh A), with early initiation deemed appropriate in cases of UDCA intolerance or partial response. Genetic studies and liver biopsy showed variability in consensus, particularly for patients without biochemical cholestasis, reflecting areas needing further research.

Conclusions: This study establishes actionable quality measures for PBC care, offering specific recommendations on diagnostic protocols, therapeutic benchmarks, and follow-up standards. These measures go beyond guidelines by addressing gaps in patient stratification, follow-up protocols, and strategies. Future research should address cost-effectiveness, access to non-invasive tools, and implementation challenges such as clinician training and resource availability.

Keywords: Delphi consensus methodology; non‐invasive diagnostic tools; obeticholic acid (OCA); primary biliary cholangitis (PBC); quality measures in PBC management.

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Conflict of interest statement

D.A.: Research Grant from Advanz Pharma. M.C.: advisor or speaker bureau member for Ipsen, Advanz, Intercept, Cymabay, Gilead, Mayoly, Echosens, Falk, Mirum, Kowa, Zydus. P.I.: Expert board member for Gilead, Ipsen, Zydus, Advanz, Barinthus, Calliditas, GSK. M.M.: Advisor for Advanz, Ipsen, Glaxo, Gilead. G.P.: speaker and/or advisor for Echosens, Novonordisk. V.C., A.C., N.C., A.F., P.P., P.T., U.V.G.: declare no conflicts of interest.

Figures

FIGURE 1
FIGURE 1
Delphi study flow chart.
FIGURE 2
FIGURE 2
Round 1—identification and diagnosis—questions 1–6.
FIGURE 3
FIGURE 3
Round 1—identification and diagnosis—questions 7–12.
FIGURE 4
FIGURE 4
Round 1—identification and diagnosis—questions 13–18.
FIGURE 5
FIGURE 5
Round 1—treatment and follow‐up—questions 1–7.
FIGURE 6
FIGURE 6
Round 1—treatment and follow‐up—questions 8–14.
FIGURE 7
FIGURE 7
Round 2—identification and diagnosis—questions 1–3/treatment and follow‐up—questions 1–2.
See this image and copyright information in PMC

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