Liver Biopsy in the Real World—Reporting, Expert Concordance and Correlation with a Pragmatic Clinical Diagnosis.

Challenge

Liver biopsy is the reference standard for NASH diagnosis, but the accuracy and completeness of pathology reporting in real-world clinical practice—and the concordance between site and central pathologists—had not been quantified, raising questions about the reliability of histological data from community and academic sites alike.

Solution

The TARGET-NASH cohort was used to audit 153 real-world pathology reports from 14 sites and compare local pathologist reads against a central expert pathologist using weighted kappa statistics, providing the first large-scale real-world concordance analysis of NASH histology.

Impact

Documenting poor to moderate concordance for key NASH histological features across real-world sites establishes the evidence base for standardizing pathology reporting in NASH clinical trials, directly informing data quality requirements for regulatory submissions.