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This study systematically reviewed RCTs focusing on CD outcomes to elucidate the breadth and depth of reported outcomes and measurement instruments. A systematic search was conducted on MEDLINE and Scopus for RCTs published from 1 January 2000 to 31 January 2023. Eligible studies included full\u2010text articles with at least 50 adult CD patients. Primary and secondary outcomes, along with their measurement instruments, were categorized according to the Outcome Measures in Rheumatology Filter 2.1 framework. From 88 included studies, 393 outcomes were analyzed. Clinical outcomes, such as clinical remission and response, were the most prevalent (50.6%); biomarkers (11.5%) and patient\u2010reported outcomes (10.2%) were also assessed. Other outcomes included disease behavior and complications (2%), endoscopy (10.4%), histology (0.5%), radiology (1.3%), healthcare utilization (3.8%), and therapy\u2010related safety (6.9%). Composite outcomes showed an increasing trend, reflecting a shift toward comprehensive evaluations. Coprimary endpoints, including clinical symptoms and mucosal inflammation, were reported in 21 of 88 studies. This review highlights the evolving landscape of outcome assessment in CD RCTs, emphasizing the increasing complexity of outcomes. The prominence of composite outcomes underscores efforts to capture the multidimensional nature of CD. These findings will inform the second stage of a two\u2010round e\u2010Delphi aimed at prioritizing key domains and outcomes for developing a multiple\u2010component outcome for RCTs in CD research.<\/jats:p>","DOI":"10.1002\/ueg2.12679","type":"journal-article","created":{"date-parts":[[2024,10,11]],"date-time":"2024-10-11T08:39:58Z","timestamp":1728635998000},"page":"1280-1291","source":"Crossref","is-referenced-by-count":8,"title":["Assessment of outcomes in Crohn's disease: A systematic review of randomized clinical trials to inform a multiple outcome framework"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4340-9581","authenticated-orcid":false,"given":"Paula Le\u00e3o","family":"Moreira","sequence":"first","affiliation":[{"name":"Department of Clinical Pharmacology Unidade Local de Sa\u00fade S\u00e3o Jo\u00e3o  Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Axel","family":"Dignass","sequence":"additional","affiliation":[{"name":"Department of Medicine I Agaplesion Markus Hospital Goethe University  Frankfurt\/Main Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7171-0139","authenticated-orcid":false,"given":"Maria Manuela","family":"Estevinho","sequence":"additional","affiliation":[{"name":"Department of Gastroenterology Unidade Local de Sa\u00fade Gaia Espinho  Vila Nova de Gaia Portugal"},{"name":"Department of Biomedicine Unit of Pharmacology and Therapeutics Faculty of Medicine University of Porto  Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francisco","family":"Portal","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Unidade Local de Sa\u00fade S\u00e3o Jo\u00e3o  Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jo\u00e3o","family":"Mendes","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacology Unidade Local de Sa\u00fade S\u00e3o Jo\u00e3o  Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mafalda","family":"Santiago","sequence":"additional","affiliation":[{"name":"GEDII\u2010Portuguese Inflammatory Bowel Disease Study Group  Porto Portugal"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"Reinisch","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine III Division Gastroenterology and Hepatology Medical University of Vienna  Vienna Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bruce E.","family":"Sands","sequence":"additional","affiliation":[{"name":"Henry D. 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