Evidence map›Paper›PMID 32699100›Full record

ReviewGut2021

Endoscopy and central reading in inflammatory bowel disease clinical trials: achievements, challenges and future developments.

Klaus Gottlieb, Marco Daperno, Keith Usiskin, Bruce E Sands, Harris Ahmad, Colin W Howden, William Karnes, Young S Oh, Irene Modesto, Colleen Marano and 2 more

Abstract readReview
In one paragraph

Review in Gut, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing 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

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

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. Article
  6. Artificial intelligence in the management of inflammatory bowel disease: What's next?World journal of gastrointestinal pharmacology and therapeutics · 2026
    Review
  7. Article
  8. Review
  9. Article
  10. Review
  11. Review
  12. Article
  13. Review
  14. Video recording in GI endoscopy.VideoGIE : an official video journal of the American Society for Gastrointestinal Endoscopy · 2025
    Article
  15. Review
  16. Review
  17. Review
  18. Review
  19. Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

12 authors.

Klaus GottliebImmunology, Eli Lilly and Company, Indianapolis, Indiana, USA klaus.gottlieb@lilly.com.ORCID 0000-0002-3747-2541
Marco DapernoA.O. Ordine Mauriziano di Torino, Torino, Italy.
Keith UsiskinImmunology, Celgene Corp, Summit, New Jersey, USA.
Bruce E SandsDr Henry D Janowitz Division of Gastroenterology, Mount Sinai School of Medicine, New York, New York, USA.
Harris AhmadImmunoscience, Bristol-Myers Squibb Co, New York, New York, USA.ORCID 0000-0002-0890-2071
Colin W HowdenGastroenterology, Univ Tennessee, Memphis, Tennessee, USA.
William KarnesGastroenterology, UC Irvine, Irvine, California, USA.
Young S OhImmunology, Genentech Inc, South San Francisco, California, USA.
Irene ModestoInflammation & Immunology, Pfizer Inc, New York, New York, USA.
Colleen MaranoJanssen Research & Development, Spring House, Pennsylvania, USA.
Ryan William StidhamInternal Medicine, University of Michigan, Ann Arbor, Michigan, USA.ORCID 0000-0001-9638-2186
Walter ReinischDepartment of Medicine IV, Medical University Vienna, Vienna, Austria.ORCID 0000-0002-2088-091X

Funding

Automated Measurement of Bowel Damage Using Enterography Imaging to Predict Clinical Outcomes in Crohn’s Disease.R01DK124779 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI STIDHAM, RYAN WILLIAM · 2020 to 2023
$2.1M
NIDDK NIH HHS R01 DK124779
6 · The paper itself

Abstract

Central reading, that is, independent, off-site, blinded review or reading of imaging endpoints, has been identified as a crucial component in the conduct and analysis of inflammatory bowel disease clinical trials. Central reading is the final step in a workflow that has many parts, all of which can be improved. Furthermore, the best reading algorithm and the most intensive central reader training cannot make up for deficiencies in the acquisition stage (clinical trial endoscopy) or improve on the limitations of the underlying score (outcome instrument). In this review, academic and industry experts review scoring systems, and propose a theoretical framework for central reading that predicts when improvements in statistical power, affecting trial size and chances of success, can be expected: Multireader models can be conceptualised as statistical or non-statistical (social). Important organisational and operational factors, such as training and retraining of readers, optimal bowel preparation for colonoscopy, video quality, optimal or at least acceptable read duration times and other quality control matters, are addressed as well. The theory and practice of central reading and the conduct of endoscopy in clinical trials are interdisciplinary topics that should be of interest to many, regulators, clinical trial experts, gastroenterology societies and those in the academic community who endeavour to develop new scoring systems using traditional and machine learning approaches.

Indexed as

ColonoscopyAlgorithmsClinical Trials as TopicEndpoint DeterminationForecastingHumansInflammatory Bowel DiseasesObserver VariationCLINICAL TRIALSENDOSCOPYINFLAMMATORY BOWEL DISEASE

Identifiers

PMID32699100
PMCPMC7815632

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.