Standardising the interpretation of liver biopsies in non-alcoholic fatty liver disease clinical trials.

ABSTRACT:

Background

There is substantial variation in how histologic definitions and scoring systems of non-alcoholic fatty liver disease (NAFLD) are operationalised.

Aim

To develop a consensus-based framework for standardising histologic assessment of liver biopsies in clinical trials of NAFLD.

Methods

An expert panel of 14 liver pathologists and three hepatologists was assembled. Using modified RAND/University of California Los Angeles appropriateness methodology, 130 items derived from literature review and expert opinion were rated by each panel member on a 1-9 scale. Disagreement was defined as ≥5 ratings in the lowest (1-3) and highest (7-9) categories. Items were classified as inappropriate (median 1-3.5 without disagreement), uncertain (median 3.5-6.5 or any median wit

SUBMITTER: Pai RK 

PROVIDER: S-EPMC6817398 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature