{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,10]],"date-time":"2025-11-10T04:30:55Z","timestamp":1762749055628,"version":"build-2065373602"},"reference-count":0,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2025,11,8]],"date-time":"2025-11-08T00:00:00Z","timestamp":1762560000000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/pages\/standard-publication-reuse-rights"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>Randomized controlled trials (RCTs) provide high-quality evidence but often lack generalizability to real-world populations. Although real-world evidence (RWE) studies help to bridge this gap but retrospective design and heterogeneous outcome measures still limit their standardization in Crohn\u2019s disease (CD). Building on the recent ECCO Position Paper, this study aimed to identify the most relevant outcomes for real-world CD studies.<\/jats:p>\n                  <jats:p>An international panel of inflammatory bowel disease (IBD) specialists participated in a structured two-round Delphi e-survey using the RAND\/UCLA Appropriateness Method. Experts rated outcomes across eight domains, including disease activity, patient-reported outcomes, and treatment safety. Agreement was assessed using the Disagreement Index (DI), where DI\u2009&amp;gt;\u20091 indicated disagreement, and DI\u2009\u2264\u20091 indicated agreement or no disagreement. Weighted scoring prioritized key outcomes.<\/jats:p>\n                  <jats:p>A total of 51\/85 experts (60%) completed Round 1 and 48\/51 (94%) Round 2. No disagreement was observed (Disagreement Index &amp;lt;1) in both rounds. The highest-ranked outcomes were Abscess or Fistula (10.6%), Endoscopic Remission (10.3%), Corticosteroid-Free Clinical Remission (8.9%), Disease Progression (6.7%), and Colorectal Cancer (5.9%). The top 10 outcomes accounted for 61.5% of the weighted score. For combinations, the top four outcomes: Corticosteroid-Free Clinical Remission (16.2%), Endoscopic Remission (15.6%), Disease Progression (14.1%), and Health-Related Quality of Life (11.9%), represented 57.8% of selections. When considering the top five and top six outcomes, the cumulative proportions were 55.4% and 57.6%, respectively.<\/jats:p>\n                  <jats:p>This expert-driven Delphi study provides a standardized framework for selecting outcomes in CD RWE studies, improving consistency, and comparability across future research in this field.<\/jats:p>","DOI":"10.1093\/ecco-jcc\/jjaf178","type":"journal-article","created":{"date-parts":[[2025,11,6]],"date-time":"2025-11-06T13:12:55Z","timestamp":1762434775000},"source":"Crossref","is-referenced-by-count":0,"title":["Establishing a Multiple Outcome Set for Crohn\u2019s Disease in Real-World Evidence Studies: Results from a Delphi e-Survey"],"prefix":"10.1093","author":[{"given":"Paula Le\u00e3o","family":"Moreira","sequence":"first","affiliation":[{"name":"Unidade Local de Sa\u00fade Department of Clinical Pharmacology, , S\u00e3o Jo\u00e3o,","place":["Portugal"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Axel","family":"Dignass","sequence":"additional","affiliation":[{"name":"Goethe University Department of Medicine I, Agaplesion Markus Hospital, , Frankfurt\/Main,","place":["Germany"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Manuela","family":"Estevinho","sequence":"additional","affiliation":[{"name":"Unidade Local de Sa\u00fade Gaia Espinho Department of Gastroenterology, , Vila Nova de Gaia,","place":["Portugal"]},{"name":"University of Porto Department of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine, , Porto,","place":["Portugal"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mafalda","family":"Santiago","sequence":"additional","affiliation":[{"name":"Portuguese Inflammatory Bowel Disease Study Group (GEDII)"},{"name":"Faculty of Medicine of the University of Porto (FMUP) CINTESIS@RISE, , Porto,","place":["Portugal"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Walter","family":"Reinisch","sequence":"additional","affiliation":[{"name":"Medical University of Vienna Department of Internal Medicine III, Division Gastroenterology and Hepatology, , Vienna,","place":["Austria"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruce E","family":"Sands","sequence":"additional","affiliation":[{"name":"Icahn School of Medicine at Mount Sinai Henry D. Janowitz Division of Gastroenterology, , New York, New York"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Geert","family":"D\u2019Haens","sequence":"additional","affiliation":[{"name":"Amsterdam University Medical Centers Amsterdam Gastroenterology Endocrinology and Metabolism, , Amsterdam,","place":["Netherlands"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerassimos J","family":"Mantzaris","sequence":"additional","affiliation":[{"name":"\u2018White Cross\u2019 and \u2018Hygeia\u2019 Hospitals Department of Gastroenterology, , Athens,","place":["Greece"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvio","family":"Danese","sequence":"additional","affiliation":[{"name":"IRCCS Ospedale San Raffaele Gastroenterology and Endoscopy, , Milan, Italy, and , Milan,","place":["Italy"]},{"name":"Vita-Salute, San Raffaele University Gastroenterology and Endoscopy, , Milan, Italy, and , Milan,","place":["Italy"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Laurent","family":"Peyrin-Biroulet","sequence":"additional","affiliation":[{"name":"Universit\u00e9 de Lorraine Department of Gastroenterology, CHRU Nancy, INSERM NGERE, , F-54500, Vand\u0153uvre-l\u00e8s-Nancy, France, Division of Gastroenterology and Hepatology, , Montreal, Quebec,","place":["Canada"]},{"name":"McGill University Health Centre Department of Gastroenterology, CHRU Nancy, INSERM NGERE, , F-54500, Vand\u0153uvre-l\u00e8s-Nancy, France, Division of Gastroenterology and Hepatology, , Montreal, Quebec,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iris","family":"Dotan","sequence":"additional","affiliation":[{"name":"Tel Aviv University Division of Gastroenterology, Rabin Medical Center, Petah Tikva, Israel, and the Faculty of Medical and Health Sciences, , Tel Aviv,","place":["Israel"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Vipul","family":"Jairath","sequence":"additional","affiliation":[{"name":"McMaster University Department of Medicine, , Hamilton, Ontario,","place":["Canada"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fernando","family":"Magro","sequence":"additional","affiliation":[{"name":"University of Porto Department of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine, , Porto,","place":["Portugal"]},{"name":"Portuguese Inflammatory Bowel Disease Study Group (GEDII)"},{"name":"Faculty of Medicine of the University of Porto (FMUP) CINTESIS@RISE, , Porto,","place":["Portugal"]},{"name":"Unidade Local de Sa\u00fade de S\u00e3o Jo\u00e3o Department of Gastroenterology, , Porto,","place":["Portugal"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"International Organization for the Study of Inflammatory Bowel Diseases (IOIBD)","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Axel","family":"Dignass","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Walter","family":"Reinisch","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruce E","family":"Sands","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Geert","family":"D\u2019Haens","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gerassimos 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