Evidence map›Paper›PMID 40318123›Full record

ArticleLiver international : official journal of the International Association for the Study of the Liver2025

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

Domenico Alvaro, Vincenza Calvaruso, Marco Carbone, Nora Cazzagon, Annarosa Floreani, Pietro Invernizzi, Marco Marzioni, Patrizio Pasqualetti, Grazia Pennisi, Pierluigi Toniutto and 2 more

Erratum issuedAbstract readConsensus Statement
In one paragraph

Article in Liver international : official journal of the International Association for the Study of the Liver, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Review
  2. Article
  3. Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Domenico AlvaroSapienza University of Rome, Rome, Italy.
Vincenza CalvarusoDepartment of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), Section of Gastroenterology and Hepatology, University of Palermo, Palermo, Italy.ORCID 0000-0002-0287-1059
Marco CarboneDepartment of Medicine and Surgery, Gastroenterology, University of Milano-Bicocca, Milan, Italy.ORCID 0000-0003-1445-0443
Nora CazzagonDepartment of Surgery, Oncology and Gastroenterology, University of Padua, Padua, Italy.ORCID 0000-0002-6937-8664
Annarosa FloreaniUniversity of Padua, Padua, Italy.
Pietro InvernizziDivision of Gastroenterology, Centre for Autoimmune Liver Diseases, European Reference Network on Hepatological Diseases (ERN RARE-LIVER), IRCCS Fondazione San Gerardo Dei Tintori, Monza, Italy.ORCID 0000-0003-3262-1998
Marco MarzioniClinic of Gastroenterology, AOU Ospedali Riuniti, Polytechnic University of Marche, Ancona, Italy.
Patrizio PasqualettiDepartment of Public Health and Infectious Diseases, Section of Health Statistics and Biometry, Faculty of Pharmacy and Medicine, Sapienza University of Rome, Rome, Italy.ORCID 0000-0001-5560-1979
Grazia PennisiDepartment of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), Section of Gastroenterology and Hepatology, University of Palermo, Palermo, Italy.
Pierluigi ToniuttoHepatology and Liver Transplant Unit, University of Udine, Udine, Italy.ORCID 0000-0002-2566-3041
Umberto Vespasiani-GentilucciUnità di Epatologia, Università Campus Biomedico di Roma, Rome, Italy.ORCID 0000-0002-1138-1967
Antonio CraxìDepartment of Health Promotion, Mother and Child Care, Internal Medicine and Medical Specialties (PROMISE), Section of Gastroenterology and Hepatology, University of Palermo, Palermo, Italy.

Funding

Advanz Pharma Italia Srl
6 · The paper itself

Abstract

BACKGROUND &

aimsPrimary 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.

methodsUsing 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.

resultsStrong 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.

conclusionsThis 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.

Indexed as

Liver Cirrhosis, BiliaryQuality Indicators, Health CareDelphi TechniqueElasticity Imaging TechniquesHumansPatient Reported Outcome MeasuresUrsodeoxycholic AcidUrsodeoxycholic AcidDelphi consensus methodologynon‐invasive diagnostic toolsobeticholic acid (OCA)primary biliary cholangitis (PBC)quality measures in PBC management

Identifiers

PMID40318123
PMCPMC12047059

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.