Evidence map›Paper›PMID 36049024›Full record

ArticleInflammatory bowel diseases2023

Validating the Simplified Endoscopic Mucosal Assessment for Crohn's Disease: A Novel Method for Assessing Disease Activity.

Jeremy Adler, Richard B Colletti, Lenore Noonan, Tyler M Berzin, Adam S Cheifetz, Laurie S Conklin, Timothy C Hoops, Christopher S Huang, Blair Lewis, Daniel S Mishkin and 3 more

Open access · hybridAbstract read
In one paragraph

Article in Inflammatory bowel diseases, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.2field-weighted citation impact, top 11% of its field
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

5 citing papers in PubMed, 12 citations in OpenAlex.

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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

13 authors at 8 institutions in 1 country.

Jeremy Adler*C.S. Mott Children's Hospital, Michigan Medicine, University of Michigan, Ann Arbor, MI, USA.ORCID 0000-0002-4857-6098
Richard B CollettiUniversity of Vermont Children's Hospital, Burlington, VT, USA.
Lenore NoonanJanssen Research & Development, LLC, Spring House, PA, USA.
Tyler M BerzinBeth Israel Deaconess Medical Center, Division of Gastroenterology, Harvard Medical School, Boston, MA, USA.
Adam S CheifetzBeth Israel Deaconess Medical Center, Division of Gastroenterology, Harvard Medical School, Boston, MA, USA.
Laurie S ConklinJanssen Research & Development, LLC, Spring House, PA, USA.
Timothy C Hoops**Immunology Global Medical Affairs, Janssen Pharmaceutical Companies (a subsidiary of Johnson & Johnson), Horsham, PA, USA.
Christopher S HuangBoston Medical Center, Section of Gastroenterology, Boston University School of Medicine, Boston, MA, USA.
Blair LewisDivision of Gastroenterology, Mount Sinai Health System, New York, NY, USA.
Daniel S MishkinAtrius Health, Division of Gastroenterology, Boston, MA, USA.
Kim Hung LoJanssen Research & Development, LLC, Spring House, PA, USA.
Yongling XiaoCytel, Inc., Waltham, MA, USA.
Sheri VolgerJanssen Research & Development, LLC, Spring House, PA, USA.
Janssen (United States) · USBeth Israel Deaconess Medical Center · USBoston University · USCytel (United States) · USJohnson & Johnson (United States) · USMount Sinai Health System · USUniversity of Michigan · USUniversity of Vermont Children’s Hospital · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundTo demonstrate treatment efficacy in Crohn's disease (CD), regulatory authorities require that trials include an endoscopic remission/response end point; however, standardized endoscopic assessment of disease activity, such as the Simple Endoscopic Score for Crohn's Disease (SES-CD), is not typically recorded by clinicians in practice or outside of clinical trials. The novel Simplified Endoscopic Mucosal Assessment for Crohn's Disease (SEMA-CD) was developed to be easy to use in routine clinical practice and as a trial end point. We conducted a study to assess and validate the reliability and feasibility of SEMA-CD as a measure of endoscopic disease activity.

methodsPre- and post-treatment ileocolonoscopy videos of pediatric (n = 36) and adult (n = 74) CD patients from 2 ustekinumab clinical trials were each scored with SEMA-CD by 2 to 3 professional central readers, blinded to clinical history and other video scorings; the correlation between SEMA-CD and SES-CD previously completed during the trials was assessed. Sensitivity to change, inter- and intrarater reliability, and comparative ease of scoring were also assessed.

resultsThe SEMA-CD strongly correlated with SES-CD (Spearman ρ = 0.89; 95% confidence interval, 0.86-0.92). Pre- to post-treatment changes in SEMA-CD vs in SES-CD were strongly correlated, and the correlation remained strong between the scores when compared by study population (pediatric, adult), disease severity, and video quality. Intra- and inter-rater reliability were good, and SEMA-CD was rated easier than SES-CD to score 63.0% of the time, although slightly more difficult than SES-CD to score <1.0% of the time.

conclusionsThe SEMA-CD is reliable, reproducible, sensitive to change, and easy to use in both pediatric and adult patients with CD.

Indexed as

Crohn DiseaseAdultChildEndoscopy, GastrointestinalHumansMucous MembraneReproducibility of ResultsSeverity of Illness IndexCrohn’s diseaseendoscopic disease activitySEMA-CDSES-CDvalidation

Identifiers

PMID36049024
PMCPMC10320367
OpenAlexW4294190928

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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.