A prospective assessment of the impact of decompensation of cirrhosis on patient-reported outcomes in metabolic dysfunction-associated steatotic liver disease.

Challenge

While decompensation is recognized as a critical clinical event in MASH cirrhosis, the specific incremental impact of decompensation on patient-reported quality of life—assessed with a disease-specific PROM—had not been quantified, leaving a gap in the clinical meaningfulness evidence for decompensation-based endpoints.

Solution

A cross-sectional analysis of NASH-CHECK data from TARGET-NASH patients with compensated vs. decompensated MASH cirrhosis was conducted, using regression models controlling for key covariates to isolate the effect of decompensation on PROM domain scores.

Impact

Demonstrating that decompensation significantly worsens patient-reported outcomes across all NASH-CHECK domains provides the clinical meaningfulness evidence needed to justify decompensation prevention as a patient-relevant endpoint in MASH trials, supporting regulatory strategies built around liver-related outcomes.