Evidence map›Paper›PMID 33610533›Full record

ArticleGastroenterology2021

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

Christopher Ma, Rocio Sedano, Ahmed Almradi, Niels Vande Casteele, Claire E Parker, Leonardo Guizzetti, David F Schaeffer, Robert H Riddell, Reetesh K Pai, Robert Battat and 15 more

Abstract readConsensus Statement
PubMed Full text at PMC Publisher
In one paragraph

Article in Gastroenterology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 55 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
55citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

55 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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  7. Article
  8. Article
  9. Article
  10. Article
  11. Article
  12. Review
  13. Novel outcomes in inflammatory bowel disease.Journal of Crohn's & colitis · 2025
    Review
  14. Article
  15. How Artificial Intelligence Will Transform Clinical Care, Research, and Trials for Inflammatory Bowel Disease.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2025
    Review
  16. Article
  17. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

Christopher MaDivision of Gastroenterology and Hepatology, Departments of Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada; Alimentiv Inc (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada. Electronic address: christopher.ma@ucalgary.ca.
Rocio SedanoDepartment of Medicine, Division of Gastroenterology, Western University, London, Ontario, Canada.
Ahmed AlmradiDepartment of Medicine, Division of Gastroenterology, Western University, London, Ontario, Canada.
Niels Vande CasteeleAlimentiv Inc (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada; Division of Gastroenterology, University of California San Diego, La Jolla, California.
Claire E ParkerAlimentiv Inc (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada.
Leonardo GuizzettiAlimentiv Inc (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada.
David F SchaefferDepartment of Pathology and Laboratory Medicine, The University of British Columbia, Vancouver, British Columbia, Canada.
Robert H RiddellDepartment of Laboratory Medicine and Pathobiology, Mount Sinai Hospital, Lunenfeld-Tanenbaum Research Institute, University of Toronto, Toronto, Ontario, Canada.
Reetesh K PaiDivision of Anatomic Pathology, Department of Pathology, University of Pittsburgh, Pittsburgh, Pennsylvania.
Robert BattatJill Roberts Center for IBD, Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York, New York.
Bruce E SandsDepartment of Medicine, The Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai Hospital, New York, New York.
Christophe RostyFaculty of Medicine, The University of Queensland, Brisbane, Queensland, Australia; Envoi Pathology, Brisbane, Queensland, Australia.
Marla C DubinskyDepartment of Pediatrics, Division of Pediatric Gastroenterology, Icahn School of Medicine at Mount Sinai Hospital, New York, New York.
Florian RiederDepartment of Gastroenterology, Hepatology and Nutrition, Digestive Diseases and Surgery Institute, Cleveland Clinic Foundation, Cleveland, Ohio; Department of Inflammation and Immunity, Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, Ohio.
Noam HarpazDepartment of Medicine, The Dr Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai Hospital, New York, New York; Department of Pathology, Molecular and Cell-Based Medicine and Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
Maria T AbreuCrohn's and Colitis Center, Division of Gastroenterology, Department of Medicine, University of Miami Leonard Miller School of Medicine, Miami, Florida.
Robert V BryantInflammatory Bowel Disease Service, Department of Gastroenterology, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia; Faculty of Health Sciences, School of Medicine, University of Adelaide, Adelaide, South Australia, Australia.
Gregory Y LauwersD.H. Lee Moffitt Cancer Center and Research Institute, University of South Florida, Tampa, Florida.
Richard KirschDepartment of Laboratory Medicine and Pathobiology, Mount Sinai Hospital, Lunenfeld-Tanenbaum Research Institute, University of Toronto, Toronto, Ontario, Canada.
Mark A ValasekDepartment of Pathology, University of California San Diego, La Jolla, California.
Eileen CrowleyDivision of Pediatric Gastroenterology, Western University, Children's Hospital, London Health Sciences Centre, London, Ontario, Canada.
William J SandbornAlimentiv Inc (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada; Division of Gastroenterology, University of California San Diego, La Jolla, California.
Brian G FeaganAlimentiv Inc (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada; Department of Medicine, Division of Gastroenterology, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.
Rish K PaiDepartment of Laboratory Medicine and Pathology, Mayo Clinic, Scottsdale, Arizona.
Vipul JairathAlimentiv Inc (formerly Robarts Clinical Trials, Inc), London, Ontario, Canada; Department of Medicine, Division of Gastroenterology, Western University, London, Ontario, Canada; Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada.

Funding

Creeping fat and Crohn's disease associated stricturesR01DK123233 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI RIEDER, FLORIAN · 2020 to 2024
$1.9M
Microbiota in Intestinal FibrosisK08DK110415 · NIDDK · CLEVELAND CLINIC LERNER COM-CWRU · PI RIEDER, FLORIAN · 2016 to 2020
$767k
NIDDK NIH HHS K08 DK110415NIDDK NIH HHS R01 DK123233
6 · The paper itself

Abstract

BACKGROUND &

aimsHistopathology 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.

methodsAn 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.

resultsHistologic 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.

conclusionsThese recommendations provide a framework for standardized implementation of histopathology in UC trials. Additional work is required to address operational considerations and areas of uncertainty.

Indexed as

Colitis, UlcerativeBiopsyClinical Trials as TopicGastroenterologyHumansPathology, ClinicalReference StandardsRemission InductionGeboes ScoreHistologyInflammatory Bowel DiseaseNancy IndexRobarts Histopathology Index

Identifiers

PMID33610533
PMCPMC8851891

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.