Hepatology communications · 2026
Measuring quality of life in advanced chronic liver disease with FACT-Hep: Findings from the PAL LIVER trial.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Verma Manisha, John Binu V, Rockey Don, Barritt Sid, Navarro Victor, Shaw Linda K, Kosinski Andrzej, Tapper Elliot B, Desai Archita P
Аннотация
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.
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.