CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease

Ma C, Hanzel J, Panaccione R, Sandborn WJ, D'Haens GR, Ahuja V, Atreya R, Bernstein CN, Bossuyt P, Bressler B, Bryant RV, Cohen B, Colombel JF, Danese S, Dignass A, Dubinsky MC, Fleshner PR, Gearry RB, Hanauer SB, Hart A, Kotze PG, Kucharzik T, Lakatos PL, Leong RW, Magro F, Panés J, Peyrin-Biroulet L, Ran Z, Regueiro M, Singh S, Spinelli A, Steinhart AH, Travis SP, van der Woude CJ, Yacyshyn B, Yamamoto T, Allez M, Bemelman WA, Lightner AL, Louis E, Rubin DT, Scherl EJ, Siegel CA, Silverberg MS, Vermeire S, Parker CE, McFarlane SC, Guizzetti L, Smith MI, Vande Casteele N, Feagan BG, Jairath V (2022)

Publication Type: Journal article

Publication year: 2022

Journal

DOI: 10.1053/j.gastro.2022.06.068

Abstract

Background & Aims: End points to determine the efficacy and safety of medical therapies for Crohn's disease (CD) and ulcerative colitis (UC) are evolving. Given the heterogeneity in current outcome measures, harmonizing end points in a core outcome set for randomized controlled trials is a priority for drug development in inflammatory bowel disease. Methods: Candidate outcome domains and outcome measures were generated from systematic literature reviews and patient engagement surveys and interviews. An iterative Delphi process was conducted to establish consensus: panelists anonymously voted on items using a 9-point Likert scale, and feedback was incorporated between rounds to refine statements. Consensus meetings were held to ratify the outcome domains and core outcome measures. Stakeholders were recruited internationally, and included gastroenterologists, colorectal surgeons, methodologists, and clinical trialists. Results: A total of 235 patients and 53 experts participated. Patient-reported outcomes, quality of life, endoscopy, biomarkers, and safety were considered core domains; histopathology was an additional domain for UC. In CD, there was consensus to use the 2-item patient-reported outcome (ie, abdominal pain and stool frequency), Crohn's Disease Activity Index, Simple Endoscopic Score for Crohn's Disease, C-reactive protein, fecal calprotectin, and co-primary end points of symptomatic remission and endoscopic response. In UC, there was consensus to use the 9-point Mayo Clinic Score, fecal urgency, Robarts Histopathology Index or Geboes Score, fecal calprotectin, and a composite primary end point including both symptomatic and endoscopic remission. Safety outcomes should be reported using the Medical Dictionary for Regulatory Activities. Conclusions: This multidisciplinary collaboration involving patients and clinical experts has produced the first core outcome set that can be applied to randomized controlled trials of CD and UC.

Authors with CRIS profile

Involved external institutions

Universidade do Porto Portugal (PT) University of Calgary Canada (CA) Alimentiv United Kingdom (GB) University of California, San Diego United States (USA) (US) Amsterdam University Medical Centers (Amsterdam UMC) / Amsterdam Universitair Medische Centra Netherlands (NL) All India Institute of Medical Sciences India (IN) University of Manitoba Canada (CA) Imelda vzw Belgium (BE) University of British Columbia Canada (CA) The Queen Elizabeth Hospital Australia (AU) Cleveland Clinic United States (USA) (US) Icahn School of Medicine at Mount Sinai United States (USA) (US) Università Vita-Salute San Raffaele (UniSR) Italy (IT) Goethe-Universität Frankfurt am Main Germany (DE) Cedars-Sinai Medical Center United States (USA) (US) University of Otago New Zealand (NZ) Northwestern University United States (USA) (US) St. Mark's Hospital United Kingdom (GB) Pontifícia Universidade Católica do Paraná (PUCPR) / Pontifical Catholic University of Paraná Brazil (BR) Universität Hamburg (UHH) Germany (DE) McGill University Canada (CA) University of Sydney (USYD) Australia (AU) Hospital Clínic de Barcelona Spain (ES) Centre Hospitalier Universitaire de Nancy / CHU Hôpitaux de Brabois France (FR) Shanghai Jiao Tong University / 上海交通大学 China (CN) Humanitas University Italy (IT) Mount Sinai Hospital (MSH) Canada (CA) John Radcliffe Hospital United Kingdom (GB) Erasmus University Medical Center (MC) Netherlands (NL) University of Cincinnati United States (USA) (US) Yokkaichi Social Insurance Hospital / 四日市羽津医療センター Japan (JP) Université Sorbonne Paris Cité France (FR) Centre Hospitalier Universitaire de Liège (CHU Liège) Belgium (BE) University of Chicago United States (USA) (US) Weill Cornell Medicine United States (USA) (US) Dartmouth-Hitchcock Medical Center (DHMC) United States (USA) (US) University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven Belgium (BE)

How to cite

APA:

Ma, C., Hanzel, J., Panaccione, R., Sandborn, W.J., D'Haens, G.R., Ahuja, V.,... Jairath, V. (2022). CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease. Gastroenterology. https://doi.org/10.1053/j.gastro.2022.06.068

MLA:

Ma, Christopher, et al. "CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease." Gastroenterology (2022).

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