Evidence map›Paper›PMID 25956538›Full record

ArticleJournal of Crohn's & colitis2015

The Impact of Clinical Information on the Assessment of Endoscopic Activity: Characteristics of the Ulcerative Colitis Endoscopic Index Of Severity [UCEIS].

Simon P L Travis, Dan Schnell, Brian G Feagan, Maria T Abreu, Douglas G Altman, Stephen B Hanauer, Piotr Krzeski, Gary R Lichtenstein, Philippe R Marteau, Jean-Yves Mary and 7 more

Abstract readEvaluation Study
In one paragraph

Article in Journal of Crohn's & colitis, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed
–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

29 citing papers in PubMed.

  1. Article
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  6. Review
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  8. Observational
  9. Observational
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  14. Relationship between Mayo endoscopic score and histological scores in ulcerative colitis: A prospective study.JGH open : an open access journal of gastroenterology and hepatology · 2020
    Article
  15. Article
  16. The role of artificial intelligence in colon polyps detection.Gastroenterology and hepatology from bed to bench · 2020
    Review
  17. Article
  18. Article
  19. Article
  20. Article
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

17 authors.

Simon P L TravisTranslational Gastroenterology Unit, John Radcliffe Hospital, Oxford, UK simon.travis@ndm.ox.ac.uk.
Dan SchnellMiddletown, OH, USA.
Brian G FeaganRobarts Research Institute, University of Western Ontario, London, ON, Canada.
Maria T AbreuDivision of Gastroenterology, University of Miami Leonard M. Miller School of Medicine, Miami, FL, USA.
Douglas G AltmanCentre for Statistics in Medicine, University of Oxford, Oxford, UK.
Stephen B HanauerDigestive Disease Center, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Piotr KrzeskiMedpace, Warsaw, Poland.
Gary R LichtensteinDivision of Gastroenterology, Department of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Philippe R MarteauAP-HP, Hôpital Lariboisière Medicosurgical Department of Digestive Diseases and University Denis Diderot, Paris, France.
Jean-Yves MaryINSERM U717 Biostatistics and Clinical Epidemiology, Université Paris Diderot, Paris, France.
Walter ReinischDivision of Gastroenterology, Department of Medicine, McMaster University, Hamilton, ON, Canada.
Bruce E SandsDr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Patrick SchnellUniversity of Minnesota, Minneapolis, MN, USA.
Bruce R YacyshynDivision of Digestive Diseases, University of Cincinnati, Cincinnati, OH, USA.
Jean-Frédéric ColombelHôpital Claude Huriez, Centre Hospitalier Universitaire de Lille, Lille, France.
Christian A BernhardtBernhardt Regulatory Consulting, Cincinnati, OH, USA.
William J SandbornDivision of Gastroenterology, University of California San Diego, La Jolla, CA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

aimsTo determine whether clinical information influences endoscopic scoring by central readers using the Ulcerative Colitis Endoscopic Index of Severity [UCEIS; comprising 'vascular pattern', 'bleeding', 'erosions and ulcers'].

methodsForty central readers performed 28 evaluations, including 2 repeats, from a library of 44 video sigmoidoscopies stratified by Mayo Clinic Score. Following training, readers were randomised to scoring with ['unblinded', n = 20, including 4 control videos with misleading information] or without ['blinded', n 20] clinical information. A total of 21 virtual Central Reader Groups [CRGs], of three blinded readers, were created. Agreement criteria were pre-specified. Kappa [κ] statistics quantified intra- and inter-reader variability.

resultsMean UCEIS scores did not differ between blinded and unblinded readers for any of the 40 main videos. UCEIS standard deviations [SD] were similar [median blinded 0.94, unblinded 0.93; p = 0.97]. Correlation between UCEIS and visual analogue scale [VAS] assessment of overall severity was high [r blinded = 0.90, unblinded = 0.93; p = 0.02]. Scores for control videos were similar [UCEIS: p ≥ 0.55; VAS: p ≥ 0.07]. Intra- [κ 0.47-0.74] and inter-reader [κ 0.40-0.53] variability for items and full UCEIS was 'moderate'-to-'substantial', with no significant differences except for intra-reader variability for erosions and ulcers [κ blinded: 0.47 vs unblinded: 0.74; p 0.047]. The SD of CRGs was lower than for individual central readers [0.54 vs 0.95; p < 0.001]. Correlation between blinded UCEIS and patient-reported symptoms was high [stool frequency: 0.76; rectal bleeding: 0.82; both: 0.81].

conclusionsThe UCEIS is minimally affected by knowledge of clinical details, strongly correlates with patient-reported symptoms, and is a suitable instrument for trials. CRGs performed better than individuals.

Indexed as

Severity of Illness IndexSigmoidoscopyColitis, UlcerativeHumansObserver VariationSingle-Blind MethodVideo Recordingdisease activity indexEndoscopic scoreulcerative colitis

Identifiers

PMID25956538
PMCPMC4584567

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Registered trials

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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.