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

CORE-IBD Collaborators; Christopher Ma¹, Jurij Hanzel², Remo Panaccione³, William J Sandborn⁴, Geert R D'Haens⁵, Vineet Ahuja⁶, Raja Atreya⁷, Charles N Bernstein⁸, Peter Bossuyt⁹, Brian Bressler¹⁰, Robert V Bryant¹¹, Benjamin Cohen¹², Jean-Frederic Colombel¹³, Silvio Danese¹⁴, Axel Dignass¹⁵, Marla C Dubinsky¹⁶, Phillip R Fleshner¹⁷, Richard B Gearry¹⁸, Stephen B Hanauer¹⁹, Ailsa Hart²⁰, Paulo Gustavo Kotze²¹, Torsten Kucharzik²², Peter L Lakatos²³, Rupert W Leong²⁴, Fernando Magro²⁵, Julian Panés²⁶, Laurent Peyrin-Biroulet²⁷, Zhihua Ran²⁸, Miguel Regueiro¹², Siddharth Singh²⁹, Antonino Spinelli³⁰, A Hillary Steinhart³¹, Simon P Travis³², C Janneke van der Woude³³, Bruce Yacyshyn³⁴, Takayuki Yamamoto³⁵, Matthieu Allez³⁶, Willem A Bemelman³⁷, Amy L Lightner³⁸, Edouard Louis³⁹, David T Rubin⁴⁰, Ellen J Scherl⁴¹, Corey A Siegel⁴², Mark S Silverberg⁴³, Severine Vermeire⁴⁴, Claire E Parker⁴⁵, Stefanie C McFarlane⁴⁵, Leonardo Guizzetti⁴⁵, Michelle I Smith⁴⁵, Niels Vande Casteele⁴, Brian G Feagan⁴⁶, Vipul Jairath⁴⁷

Affiliations

¹ 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.
² Alimentiv Inc, London, Ontario, Canada; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia; Department of Gastroenterology, University Medical Center Ljubljana, Ljubljana, Slovenia.
³ Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada.
⁴ Division of Gastroenterology, University of California San Diego, La Jolla, California.
⁵ Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
⁶ Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
⁷ Medical Department I, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
⁸ 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.
⁹ Imelda Gastrointestinal Clinical Research Center, Imelda General Hospital, Bonheiden, Belgium.
¹⁰ Department of Medicine, Division of Gastroenterology, St Paul's Hospital, University of British Columbia, British Columbia, Canada.
¹¹ 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.
¹² Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, Ohio.
¹³ Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
¹⁴ Department of Gastroenterology and Endoscopy, Vita-Salute San Raffaele University, Milan, Italy; Department of Gastroenterology and Endoscopy, San Raffaele Hospital, Milan, Italy.
¹⁵ Department of Medicine I, Agaplesion Markus Hospital, Goethe-University, Frankfurt am Main, Germany.
¹⁶ Department of Pediatrics, Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
¹⁷ Division of Colorectal Surgery, Cedars-Sinai Medical Center, Los Angeles, California.
¹⁸ Department of Medicine, University of Otago, Christchurch, New Zealand.
¹⁹ Department of Medicine (Gastroenterology and Hepatology), Northwestern University, Chicago, Illinois.
²⁰ Department of Gastroenterology, St Mark's Hospital and Academic Institute, Harrow, United Kingdom.
²¹ Inflammatory Bowel Disease Outpatient Clinics, Colorectal Surgery Unit, Pontificia Universidade Catolica do Paraná, Curitiba, Brazil.
²² Department of Gastroenterology, Lüneburg Hospital, University of Hamburg, Lüneburg, Germany.
²³ Division of Gastroenterology, McGill University, Montreal, Canada; 1st Department of Medicine, Semmelweis University, Budapest, Hungary.
²⁴ The University of Sydney, Sydney, New South Wales, Australia; Concord Repatriation General Hospital, Sydney, New South Wales, Australia.
²⁵ 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.
²⁶ Hospital Clinic Barcelona, August Pi i Sunyer Biomedical Research Institute, Biomedical Research Networking Center in Hepatic and Digestive Disease, Barcelona, Spain.
²⁷ Department of Gastroenterology, INSERM NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France.
²⁸ 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.
²⁹ Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla, California.
³⁰ Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Istituto di Ricovero e Cura a Carattere Scientifico, Humanitas Research Hospital, Rozzano, Milan, Italy.
³¹ Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, Ontario, Canada; Division of Gastroenterology and Hepatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
³² Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, United Kingdom.
³³ Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.
³⁴ Department of Internal Medicine, University of Cincinnati, Cincinnati, Ohio.
³⁵ Inflammatory Bowel Disease Center and Department of Surgery, Yokkaichi Hazu Medical Center, Yokkaichi, Japan.
³⁶ Department of Gastroenterology, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, INSERM U1160, Université de Paris, Paris, Île-de-France, France.
³⁷ Department of Surgery, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
³⁸ Department of Colorectal Surgery, Cleveland Clinic, Cleveland, Ohio.
³⁹ Hepato-Gastroenterology and Digestive Oncology Department, University and Centre Hospitalier Universitaire Liège, Liège, Belgium.
⁴⁰ University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, Illinois.
⁴¹ Jill Roberts Center for Inflammatory Bowel Disease, Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York, New York.
⁴² Inflammatory Bowel Disease Center, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
⁴³ Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, Ontario, Canada.
⁴⁴ Department of Gastroenterology and Hepatology, University Hospitals Leuven, Katholieke Universiteit Leuven, Leuven, Belgium.
⁴⁵ Alimentiv Inc, London, Ontario, Canada.
⁴⁶ 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.
⁴⁷ 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.

PMID: 35788348
DOI: 10.1053/j.gastro.2022.06.068

Free article

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

CORE-IBD Collaborators et al. Gastroenterology. 2022 Oct.

Free article

. 2022 Oct;163(4):950-964.

doi: 10.1053/j.gastro.2022.06.068. Epub 2022 Jul 3.

Authors

Affiliations

¹ 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.
² Alimentiv Inc, London, Ontario, Canada; Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia; Department of Gastroenterology, University Medical Center Ljubljana, Ljubljana, Slovenia.
³ Inflammatory Bowel Disease Unit, Division of Gastroenterology and Hepatology, University of Calgary, Calgary, Alberta, Canada.
⁴ Division of Gastroenterology, University of California San Diego, La Jolla, California.
⁵ Department of Gastroenterology and Hepatology, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
⁶ Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India.
⁷ Medical Department I, University Hospital Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Germany.
⁸ 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.
⁹ Imelda Gastrointestinal Clinical Research Center, Imelda General Hospital, Bonheiden, Belgium.
¹⁰ Department of Medicine, Division of Gastroenterology, St Paul's Hospital, University of British Columbia, British Columbia, Canada.
¹¹ 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.
¹² Department of Gastroenterology, Hepatology, and Nutrition, Cleveland Clinic, Cleveland, Ohio.
¹³ Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
¹⁴ Department of Gastroenterology and Endoscopy, Vita-Salute San Raffaele University, Milan, Italy; Department of Gastroenterology and Endoscopy, San Raffaele Hospital, Milan, Italy.
¹⁵ Department of Medicine I, Agaplesion Markus Hospital, Goethe-University, Frankfurt am Main, Germany.
¹⁶ Department of Pediatrics, Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York.
¹⁷ Division of Colorectal Surgery, Cedars-Sinai Medical Center, Los Angeles, California.
¹⁸ Department of Medicine, University of Otago, Christchurch, New Zealand.
¹⁹ Department of Medicine (Gastroenterology and Hepatology), Northwestern University, Chicago, Illinois.
²⁰ Department of Gastroenterology, St Mark's Hospital and Academic Institute, Harrow, United Kingdom.
²¹ Inflammatory Bowel Disease Outpatient Clinics, Colorectal Surgery Unit, Pontificia Universidade Catolica do Paraná, Curitiba, Brazil.
²² Department of Gastroenterology, Lüneburg Hospital, University of Hamburg, Lüneburg, Germany.
²³ Division of Gastroenterology, McGill University, Montreal, Canada; 1st Department of Medicine, Semmelweis University, Budapest, Hungary.
²⁴ The University of Sydney, Sydney, New South Wales, Australia; Concord Repatriation General Hospital, Sydney, New South Wales, Australia.
²⁵ 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.
²⁶ Hospital Clinic Barcelona, August Pi i Sunyer Biomedical Research Institute, Biomedical Research Networking Center in Hepatic and Digestive Disease, Barcelona, Spain.
²⁷ Department of Gastroenterology, INSERM NGERE U1256, University Hospital of Nancy, University of Lorraine, Vandoeuvre-lès-Nancy, France.
²⁸ 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.
²⁹ Division of Gastroenterology, Department of Medicine, University of California, San Diego, La Jolla, California.
³⁰ Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Istituto di Ricovero e Cura a Carattere Scientifico, Humanitas Research Hospital, Rozzano, Milan, Italy.
³¹ Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, Ontario, Canada; Division of Gastroenterology and Hepatology, Department of Medicine, University of Toronto, Toronto, Ontario, Canada.
³² Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford, United Kingdom.
³³ Department of Gastroenterology and Hepatology, Erasmus Medical Center, Rotterdam, The Netherlands.
³⁴ Department of Internal Medicine, University of Cincinnati, Cincinnati, Ohio.
³⁵ Inflammatory Bowel Disease Center and Department of Surgery, Yokkaichi Hazu Medical Center, Yokkaichi, Japan.
³⁶ Department of Gastroenterology, Hôpital Saint-Louis, Assistance Publique-Hôpitaux de Paris, INSERM U1160, Université de Paris, Paris, Île-de-France, France.
³⁷ Department of Surgery, Amsterdam University Medical Centers, Amsterdam, The Netherlands.
³⁸ Department of Colorectal Surgery, Cleveland Clinic, Cleveland, Ohio.
³⁹ Hepato-Gastroenterology and Digestive Oncology Department, University and Centre Hospitalier Universitaire Liège, Liège, Belgium.
⁴⁰ University of Chicago Medicine, Inflammatory Bowel Disease Center, Chicago, Illinois.
⁴¹ Jill Roberts Center for Inflammatory Bowel Disease, Division of Gastroenterology and Hepatology, Weill Cornell Medicine, New York, New York.
⁴² Inflammatory Bowel Disease Center, Section of Gastroenterology and Hepatology, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire.
⁴³ Mount Sinai Hospital Inflammatory Bowel Disease Centre, Toronto, Ontario, Canada.
⁴⁴ Department of Gastroenterology and Hepatology, University Hospitals Leuven, Katholieke Universiteit Leuven, Leuven, Belgium.
⁴⁵ Alimentiv Inc, London, Ontario, Canada.
⁴⁶ 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.
⁴⁷ 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.

PMID: 35788348
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.

Keywords: Crohn’s Disease; End Point; Outcomes; Ulcerative Colitis.

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

Affiliations

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

Authors

Affiliations

Abstract

Publication types

MeSH terms

Substances

Grants and funding

LinkOut - more resources

Full Text Sources

Medical

Research Materials