Measuring quality of life in advanced chronic liver disease with FACT-Hep: Findings from the PAL LIVER trial.

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.