Document Type

Article

Publication Date

9-1-2026

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This article is the author’s final published version in Hepatology Communications, Volume 10, Issue 9, 2026, Article number e1043.

The published version is available at https://doi.org/10.1097/HC9.0000000000001043. Copyright © 2026 The Author(s).

 

Abstract

BACKGROUND: Patient-reported outcome measures (PROMs) are increasingly incorporated into hepatology research, yet few have been rigorously evaluated, particularly among patients with decompensated cirrhosis. The Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) captures multidimensional liver disease-specific burden, while the disease-agnostic PROMIS-29 assesses physical and mental health broadly. We evaluated the performance of FACT-Hep and its relationship to PROMIS-29 among participants with cirrhosis or hepatocellular carcinoma (HCC) enrolled in a prospective multicenter clinical trial.

METHODS: Baseline data were analyzed from 935 participants enrolled in the PAL LIVER trial. This study enrolled patients with Child-Turcotte-Pugh (CTP) B/C cirrhosis and/or with HCC. Health-related quality of life (HRQoL) was assessed using FACT-Hep and PROMIS-29. Correlations and multivariable linear regression models examined associations between PROM scores and clinical characteristics.

RESULTS: Among 935 patients, the mean FACT-Hep total score was 116 (SD 28.16), with worse scores among women, young participants (age < 50 y), and Whites (all p< 0.05). Patients with CTP B/C cirrhosis (83%) had worse HRQoL than those with HCC alone (28%) (p< 0.0001). Younger age, higher MELD 3.0, smoking, and worse ECOG status were independently associated with total FACT-Hep score. FACT-Hep correlated with PROMIS preference scores (correlation coefficient=0.78). MELD 3.0 demonstrated a stronger association with total FACT-Hep score than with PROMIS measures.

CONCLUSIONS: HRQoL measures provide important information distinct from disease severity indices. HRQoL impairment in patients with advanced chronic liver disease is driven primarily by decompensation, particularly ascites and hepatic encephalopathy. FACT-Hep and PROMIS-29 correlate well. FACT-Hep is a valid measure and effectively captures the multidimensional liver disease-specific burden. PROMIS-29 measures broader aspects that may be influenced by many factors beyond liver disease.

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Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.

Additional Files
Model Summary.docx (70 kB)
Supplemental Figure 1-2.pdf (416 kB)
Supplementary Table.pdf (292 kB)

Language

English

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