An International Consensus to Standardize Integration of Histopathology in Ulcerative Colitis Clinical Trials.

ABSTRACT:

Background & aims

Histopathology is an emerging treatment target in ulcerative colitis (UC) clinical trials. Our aim was to provide guidance on standardizing biopsy collection protocols, identifying optimal evaluative indices, and defining thresholds for histologic response and remission after treatment.

Methods

An international, interdisciplinary expert panel of 19 gastroenterologists and gastrointestinal pathologists was assembled. A modified RAND/University of California, Los Angeles appropriateness methodology was used to address relevant issues. A total of 138 statements were derived from a systematic review of the literature and expert opinion. Each statement was anonymously rated as appropriate, uncertain, or inappropriate using a 9-point scale. Survey results were re

SUBMITTER: Ma C 

PROVIDER: S-EPMC8851891 | biostudies-literature | 2021 Jun

REPOSITORIES: biostudies-literature