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

## TL;DR

This study creates quality measures for managing Primary Biliary Cholangitis through a Delphi consensus, aiming to improve diagnosis, treatment, and patient care.

## Contribution

The study introduces consensus-driven quality measures to address gaps in PBC management, particularly in diagnostic and follow-up standards.

## Key findings

- Non-invasive tools like VCTE and abdominal ultrasound received strong consensus for staging and monitoring fibrosis.
- Early treatment initiation is appropriate for patients with UDCA intolerance or partial response.
- Genetic studies and liver biopsy showed variability in consensus, highlighting areas needing further research.

## Abstract

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.

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.

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.

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.