Stability of the NASH-CHECK patient-reported outcome measure over time in patients with metabolic dysfunction-associated steatotic liver disease and stable clinical status.

Challenge

Patient-reported outcomes are increasingly required for MASH drug approvals, but the regulatory requirement for PROM stability—demonstrating that scores do not change in clinically stable patients—had not been established for the NASH-CHECK instrument, limiting its acceptability as a trial endpoint.

Solution

A longitudinal analysis of TARGET-NASH patients who completed NASH-CHECK at two timepoints with stable MASLD disease severity was conducted to test whether PROM scores remained statistically unchanged across disease subgroups over a mean follow-up of approximately 10 months.

Impact

Demonstrating NASH-CHECK stability in clinically stable patients satisfies a core psychometric validation requirement for regulatory acceptance of disease-specific PROMs as MASH trial endpoints, advancing the instrument toward use in label-supporting clinical trials.