{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T23:22:18Z","timestamp":1787008938884,"version":"build-2736575974"},"reference-count":21,"publisher":"Oxford University Press (OUP)","issue":"7","license":[{"start":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T00:00:00Z","timestamp":1661990400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100005205","name":"Janssen Research & Development","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100005205","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2023,7,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>To demonstrate treatment efficacy in Crohn\u2019s 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\u2019s Disease (SES-CD), is not typically recorded by clinicians in practice or outside of clinical trials. The novel Simplified Endoscopic Mucosal Assessment for Crohn\u2019s 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>Pre- and post-treatment ileocolonoscopy videos of pediatric (n\u2005=\u200536) and adult (n\u2005=\u200574) 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>The SEMA-CD strongly correlated with SES-CD (Spearman \u03c1 = 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 &amp;lt;1.0% of the time.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The SEMA-CD is reliable, reproducible, sensitive to change, and easy to use in both pediatric and adult patients with CD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/ibd\/izac183","type":"journal-article","created":{"date-parts":[[2022,9,1]],"date-time":"2022-09-01T14:33:37Z","timestamp":1662042817000},"page":"1089-1097","source":"Crossref","is-referenced-by-count":14,"title":["Validating the Simplified Endoscopic Mucosal Assessment for Crohn\u2019s Disease: A Novel Method for Assessing Disease Activity"],"prefix":"10.1093","volume":"29","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4857-6098","authenticated-orcid":false,"given":"Jeremy","family":"Adler","sequence":"first","affiliation":[{"name":"C.S. Mott Children\u2019s Hospital, Michigan Medicine, University of Michigan * , Ann Arbor, MI , USA"},{"name":"Susan B. Meister Child Health Evaluation and Research Center, Michigan Medicine, University of Michigan , Ann Arbor, MI , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard B","family":"Colletti","sequence":"additional","affiliation":[{"name":"University of Vermont Children\u2019s Hospital , Burlington, VT , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lenore","family":"Noonan","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC , Spring House, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tyler M","family":"Berzin","sequence":"additional","affiliation":[{"name":"Beth Israel Deaconess Medical Center, Division of Gastroenterology, Harvard Medical School , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Adam S","family":"Cheifetz","sequence":"additional","affiliation":[{"name":"Beth Israel Deaconess Medical Center, Division of Gastroenterology, Harvard Medical School , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurie S","family":"Conklin","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC , Spring House, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timothy C","family":"Hoops","sequence":"additional","affiliation":[{"name":"Immunology Global Medical Affairs, Janssen Pharmaceutical Companies (a subsidiary of Johnson & Johnson) ** , Horsham, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher S","family":"Huang","sequence":"additional","affiliation":[{"name":"Boston Medical Center, Section of Gastroenterology, Boston University School of Medicine , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Blair","family":"Lewis","sequence":"additional","affiliation":[{"name":"Division of Gastroenterology, Mount Sinai Health System , New York, NY , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniel S","family":"Mishkin","sequence":"additional","affiliation":[{"name":"Atrius Health, Division of Gastroenterology , Boston, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kim","family":"Hung Lo","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC , Spring House, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yongling","family":"Xiao","sequence":"additional","affiliation":[{"name":"Cytel, Inc. , Waltham, MA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sheri","family":"Volger","sequence":"additional","affiliation":[{"name":"Janssen Research & Development, LLC , Spring House, PA , USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,9,1]]},"reference":[{"key":"2023070506312027100_CIT0001","author":"United States Food and Drug Administration"},{"key":"2023070506312027100_CIT0002","author":"European Medicines Agency"},{"issue":"6","key":"2023070506312027100_CIT0003","doi-asserted-by":"crossref","first-page":"2013","DOI":"10.1053\/j.gastro.2020.07.064","article-title":"IOIBD Defining Endpoints and Biomarkers in Inflammatory Bowel Disease Writing Group. 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