CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease.
[en] [en] 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.
Disciplines :
Gastroenterology & hepatology
Author, co-author :
CORE-IBD Collaborators
Ma, Christopher ; Division of Gastroenterology and Hepatology, Departments of Medicine and Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada, Alimentiv Inc, London, Ontario, Canada. Electronic address: christopher.ma@ucalgary.ca
Hanzel, Jurij; Alimentiv Inc, London, Ontario, Canada, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia, Department of Gastroenterology, University Medical Center Ljubljana, Ljubljana, Slovenia
Panaccione, Remo; Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada
Sandborn, William J; Division of Gastroenterology, University of California San Diego, La Jolla, California
D'Haens, Geert R; Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands
Ahuja, Vineet; Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India
Atreya, Raja; Medical Department I, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany
Bernstein, Charles N; Department of Internal Medicine, Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Manitoba, Canada, University of Manitoba Inflammatory Bowel Disease Clinical and Research Centre, Winnipeg, Manitoba, Canada
Bossuyt, Peter; Imelda Gastrointestinal Clinical Research Center, Imelda General Hospital, Bonheiden, Belgium
Bressler, Brian; Department of Medicine, Division of Gastroenterology, St Paul's Hospital, University of British Columbia, British Columbia, Canada
Bryant, Robert V; Inflammatory Bowel Disease Service, Department of Gastroenterology and Hepatology, The Queen Elizabeth Hospital, Adelaide, South Australia, Australia, School of Medicine, Faculty of Health Sciences University of Adelaide, Adelaide, South Australia, Australia
Cohen, Benjamin; Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, Ohio
Colombel, Jean-Frederic; Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York
Danese, Silvio; Department of Gastroenterology and Endoscopy, Vita-Salute San Raffaele University, Milan, Italy, Department of Gastroenterology and Endoscopy, San Raffaele Hospital, Milan, Italy
Dignass, Axel; Department of Medicine I, Agaplesion Markus Hospital, Goethe-University, Frankfurt am Main, Germany
Dubinsky, Marla C; Department of Pediatrics, Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York
Fleshner, Phillip R; Division of Colorectal Surgery, Cedars-Sinai Medical Center, Los Angeles, California
Gearry, Richard B; Department of Medicine, University of Otago, Christchurch, New Zealand
Hanauer, Stephen B; Department of Medicine (Gastroenterology and Hepatology), Northwestern University, Chicago, Illinois
Hart, Ailsa; Department of Gastroenterology, St Mark's Hospital and Academic Institute, Harrow, United Kingdom
Kotze, Paulo Gustavo; Inflammatory Bowel Disease Outpatient Clinics, Colorectal Surgery Unit, Pontificia Universidade Catolica do Paraná, Curitiba, Brazil
Kucharzik, Torsten; Department of Gastroenterology, Lüneburg Hospital, University of Hamburg, Lüneburg, Germany
Lakatos, Peter L; Division of Gastroenterology, McGill University, Montreal, Canada, 1st Department of Medicine, Semmelweis University, Budapest, Hungary
Leong, Rupert W; The University of Sydney, Sydney, New South Wales, Australia, Concord Repatriation General Hospital, Sydney, New South Wales, Australia
Magro, Fernando; Department of Biomedicine, Unit of Pharmacology and Therapeutics, Faculty of Medicine, University of Porto, Porto, Portugal, Department of Clinical Pharmacology, São João University Hospital Center, Porto, Portugal, Faculty of Medicine, University of Porto, Portugal, Center for Health Technology and Services Research, Porto, Portugal
Panés, Julian; Hospital Clinic Barcelona, August Pi i Sunyer Biomedical Research Institute, Biomedical Research Networking Center in Hepatic and Digestive Disease, Barcelona, Spain
Peyrin-Biroulet, Laurent; Department of Gastroenterology, INSERM NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France
Ran, Zhihua; Division of Gastroenterology and Hepatology, Key Laboratory of Gastroenterology and Hepatology, Ministry of Health, Shanghai Inflammatory Bowel Disease Research Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai Institute of Digestive Disease, Shanghai, China
Regueiro, Miguel; Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, Ohio
Singh, Siddharth; Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla, California
Spinelli, Antonino; Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy, Istituto di Ricovero e Cura a Carattere Scientifico, Humanitas Research Hospital, Rozzano, Milan, Italy
Steinhart, A Hillary; Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, Ontario, Canada, Division of Gastroenterology and Hepatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada
Travis, Simon P; Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, United Kingdom
van der Woude, C Janneke; Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands
Yacyshyn, Bruce; Department of Internal Medicine, University of Cincinnati, Cincinnati, Ohio
Yamamoto, Takayuki; Inflammatory Bowel Disease Center and Department of Surgery, Yokkaichi Hazu Medical Center, Yokkaichi, Japan
Allez, Matthieu; Department of Gastroenterology, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, INSERM U1160, Université de Paris, Paris, Île-de-France, France
Bemelman, Willem A; Department of Surgery, Amsterdam University Medical Centers, Amsterdam, The Netherlands
Lightner, Amy L; Department of Colorectal Surgery, Cleveland Clinic, Cleveland, Ohio
Louis, Edouard ; Centre Hospitalier Universitaire de Liège - CHU > > Service de gastroentérologie, hépatologie, onco. digestive
Rubin, David T; University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, Illinois
Scherl, Ellen J; Jill Roberts Center for Inflammatory Bowel Disease, Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York, New York
Siegel, Corey A; Inflammatory Bowel Disease Center, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire
Silverberg, Mark S; Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, Ontario, Canada
Vermeire, Severine; Department of Gastroenterology and Hepatology, University Hospitals Leuven, Katholieke Universiteit Leuven, Leuven, Belgium
Vande Casteele, Niels; Division of Gastroenterology, University of California San Diego, La Jolla, California
Feagan, Brian G; Alimentiv Inc, London, Ontario, Canada, Department of Medicine, Division of Gastroenterology, Western University, London, Ontario, Canada, Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada
Jairath, Vipul; Alimentiv Inc, London, Ontario, Canada, Department of Medicine, Division of Gastroenterology, Western University, London, Ontario, Canada, Department of Epidemiology and Biostatistics, Western University, London, Ontario, Canada. Electronic address: vjairath@uwo.ca
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