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An International Consensus to Standardize Integration of Histopathology in Ulcerative Colitis Clinical Trials
- Source :
- Gastroenterology, Paediatrics Publications
- Publication Year :
- 2020
-
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 reviewed and discussed before a second round of voting. Results Histologic measurements collected using a uniform biopsy strategy are important for assessing disease activity and determining therapeutic efficacy in UC clinical trials. Multiple biopsy strategies were deemed acceptable, including segmental biopsies collected according to the endoscopic appearance. Biopsies should be scored for architectural change, lamina propria chronic inflammation, basal plasmacytosis, lamina propria and epithelial neutrophils, epithelial damage, and erosions/ulcerations. The Geboes score, Robarts Histopathology Index, and Nancy Index were considered appropriate for assessing histologic activity; use of the modified Riley score and Harpaz Index were uncertain. Histologic activity at baseline should be required for enrollment, recognizing this carries operational implications. Achievement of histologic improvement or remission was considered an appropriate and realistic therapeutic target. Current histologic indices require validation for pediatric populations. Conclusions These recommendations provide a framework for standardized implementation of histopathology in UC trials. Additional work is required to address operational considerations and areas of uncertainty.
- Subjects :
- 0301 basic medicine
medicine.medical_specialty
Histology
Consensus
Nancy Index
Biopsy
Inflammatory bowel disease
Article
03 medical and health sciences
0302 clinical medicine
Internal medicine
medicine
Humans
Architectural change
Lamina propria
Clinical Trials as Topic
Pathology, Clinical
Hepatology
medicine.diagnostic_test
business.industry
Inflammatory Bowel Disease
Plasmacytosis
Remission Induction
Gastroenterology
Reference Standards
medicine.disease
Ulcerative colitis
Geboes Score
Clinical trial
030104 developmental biology
medicine.anatomical_structure
Robarts Histopathology Index
030211 gastroenterology & hepatology
Histopathology
Colitis, Ulcerative
business
Subjects
Details
- ISSN :
- 15280012
- Volume :
- 160
- Issue :
- 7
- Database :
- OpenAIRE
- Journal :
- Gastroenterology
- Accession number :
- edsair.doi.dedup.....23b414ce9ffc2273916e4c68a03e5274