Patient Determinants for Histologic Diagnosis of NAFLD in the Real World: A TARGET‐NASH Study.

Challenge

The drivers of liver biopsy utilization in real-world NAFLD care were poorly understood, with no large-scale data on which patient characteristics—demographic, clinical, or geographic—predicted histological diagnosis versus reliance on clinical criteria alone.

Solution

The TARGET-NASH cohort was analyzed to identify patient-level determinants of biopsy receipt across academic and community sites, characterizing the gap between biopsy-confirmed and clinically diagnosed NAFLD patients in usual practice.

Impact

Understanding who receives biopsies in real-world care informs trial site selection, enrichment strategies, and the design of biopsy-sparing endpoints, helping sponsors build more generalizable and feasible NAFLD development programs.