CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease
Uloženo v:
| Název: | CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease |
|---|---|
| Autoři: | Ma, Christopher, Hanzel, Jurij, Panaccione, Remo, Sandborn, William, d'Haens, Geert, Ahuja, Vineet, Atreya, Raja, Bernstein, Charles, Bossuyt, Peter, Bressler, Brian, Bryant, Robert, Cohen, Benjamin, Colombel, Jean-Frederic, Danese, Silvio, Dignass, Axel, Dubinsky, Marla, Fleshner, Phillip, Gearry, Richard, Hanauer, Stephen, Hart, Ailsa, Kotze, Paulo Gustavo, Kucharzik, Torsten, Lakatos, Peter, Leong, Rupert, Magro, Fernando, Panés, Julian, Peyrin‐biroulet, Laurent, Ran, Zhihua, Regueiro, Miguel, Singh, Siddharth, Spinelli, Antonino, Steinhart, A Hillary, Travis, Simon, van der Woude, C Janneke, Yacyshyn, Bruce, Yamamoto, Takayuki, Allez, Matthieu, Bemelman, Willem, Lightner, Amy, Louis, Edouard, Rubin, David, Scherl, Ellen, Siegel, Corey, Silverberg, Mark, Vermeire, Severine, Parker, Claire, Mcfarlane, Stefanie, Guizzetti, Leonardo, Smith, Michelle, Vande Casteele, Niels, Feagan, Brian, Jairath, Vipul, D’haens, Geert, Steinhart, A. Hillary, van der Woude, C. Janneke |
| Přispěvatelé: | Collaborators, CORE-IBD, CIHR - Canadian Institutes of Health Research, GROSJEAN, Benjamin |
| Zdroj: | Gastroenterology. 163:950-964 |
| Informace o vydavateli: | Elsevier BV, 2022. |
| Rok vydání: | 2022 |
| Témata: | Crohn's disease, CORE-IBD Collaborators, Consensus, MULTICENTER, Crohn's Disease, Outcomes, Crohn Disease/diagnosis, outcomes, Sciences de la santé humaine, Colitis, Ulcerative/diagnosis, 03 medical and health sciences, 0302 clinical medicine, Crohn Disease, Outcome Assessment, Health Care, MANAGEMENT, Ulcerative Colitis, Humans, Human health sciences, ulcerative colitis, Randomized Controlled Trials as Topic, Science & Technology, Hepatology, Gastroenterology & Hepatology, 3210 Nutrition and dietetics, C-Reactive Protein/metabolism, endpoint, Gastroenterology, 3202 Clinical sciences, 1103 Clinical Sciences, Gastroentérologie & hépatologie, Inflammatory Bowel Diseases, End Point, 3. Good health, [SDV] Life Sciences [q-bio], Inflammatory Bowel Diseases/therapy, C-Reactive Protein, ULCERATIVE-COLITIS, Crohn Disease/drug therapy, Chronic Disease, Quality of Life, 1114 Paediatrics and Reproductive Medicine, Colitis, Ulcerative, Colitis, Ulcerative/drug therapy, 1109 Neurosciences, Gastroenterology & hepatology, Life Sciences & Biomedicine, Leukocyte L1 Antigen Complex, Biomarkers |
| Popis: | 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.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.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.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. |
| Druh dokumentu: | Article |
| Jazyk: | English |
| ISSN: | 0016-5085 |
| DOI: | 10.1053/j.gastro.2022.06.068 |
| Přístupová URL adresa: | https://pubmed.ncbi.nlm.nih.gov/35788348 https://pure.amsterdamumc.nl/en/publications/6fd8b9e1-8f20-46f1-948d-22037e475832 https://doi.org/10.1053/j.gastro.2022.06.068 https://lirias.kuleuven.be/handle/20.500.12942/699652 https://doi.org/10.1053/j.gastro.2022.06.068 https://hdl.handle.net/2268/300572 https://doi.org/10.1053/j.gastro.2022.06.068 https://hal.univ-lorraine.fr/hal-04165953v1 https://doi.org/10.1053/j.gastro.2022.06.068 |
| Rights: | Elsevier TDM CC BY NC ND |
| Přístupové číslo: | edsair.doi.dedup.....d1621d7255b59bd435bc53e039201424 |
| Databáze: | OpenAIRE |
Full Text Finder 
Nájsť tento článok vo Web of Science | Abstrakt: | 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.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.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.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. |
|---|---|
| ISSN: | 00165085 |
| DOI: | 10.1053/j.gastro.2022.06.068 |