Heterogeneous Documentation and Poor Concordance of NASH Pathology May Limit its Clinical Utility in Real-World Practice

Liver biopsy-based NASH diagnosis is only as reliable as the quality and completeness of the pathology reports generated in routine practice, yet the degree of heterogeneity and incompleteness in real-world NASH pathology documentation had never been systematically audited at scale.

NASH-related pathology reports from 14 TARGET-NASH sites were audited for documentation completeness, and a subset of biopsy slides were centrally re-read, with concordance between local and central pathologists assessed using weighted kappa statistics across all key histological features.

Documenting that critical NASH histological features are routinely missing from real-world pathology reports—and that local-central concordance is only fair to moderate—establishes the evidence base for mandatory central reading and standardized reporting in NASH drug development, directly informing regulatory guidance expectations.

Histological data quality audit for NASH trial readiness and regulatory compliance, Pathology concordance evidence supporting central reading requirements in MASH programs, Real-world reporting gap analysis informing NASH endpoint validity standards