Suboptimal reliability of liver biopsy evaluation has implications for randomized clinical trials
Abstract
•Liver biopsy is a critical inclusion criteria and outcome measure in NASH studies. •Reader variability was tested in 678 biopsies from a NASH study of MSDC-0602K. •Kappas were poor for the diagnosis of NASH, its resolution and fibrosis improvement. •Almost half of the patients would have been excluded from entry by 1 of the readers. •Poor reliability allows improper entry, misclassification, and diminishes treatment effect. Background & Aims...
Paper Details
Title
Suboptimal reliability of liver biopsy evaluation has implications for randomized clinical trials
Published Date
Dec 1, 2020
Journal
Volume
73
Issue
6
Pages
1322 - 1332
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