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