Publications Development of a Core Outcome Set for Clinical Trials in Inflammatory Bowel Disease: Study Protocol for a Systematic Review of the Literature and Identification of a Core Outcome Set Using a Delphi Survey Citation Ma C, Panaccione R, Fedorak RN, Parker CE, Khanna R, Levesque BG, Sandborn WJ, Feagan BG, Jairath V. Development of a core outcome set for clinical trials in inflammatory bowel disease: study protocol for a systematic review of the literature and identification of a core outcome set using a Delphi survey. BMJ Open. 2017 Jun 9;7(6):e016146. doi: 10.1136/bmjopen-2017-016146. PMID: 28601837; PMCID: PMC5726090. Abstract Introduction: Crohn’s disease (CD) and ulcerative colitis (UC), the main forms of inflammatory bowel disease (IBD), are chronic, progressive and disabling disorders of the gastrointestinal tract. Although data from randomised controlled trials (RCTs) provide the foundation of evidence that validates medical therapy for IBD, considerable heterogeneity exists in the measured outcomes used in these studies. Furthermore, in recent years, there has been a paradigm shift in IBD treatment targets, moving from symptom-based scoring to improvement or normalisation of objective measures of inflammation such as endoscopic appearance, inflammatory biomarkers and histological and radiographic end points. The abundance of new treatment options and evolving end points poses opportunities and challenges for all stakeholders involved in drug development. Accordingly, there exists a need to harmonise measures used in clinical trials through the development of a core outcome set (COS). Tags Consensus Methods, Core Outcome Set, Crohn's Disease, Delphi, Delphi Technique, Drug Therapy, IBD, Inflammatory Bowel Diseases, Outcome Assessment, Research Design, Systematic Review, Ulcerative Colitis Read More