Portal de investigação
CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease
Data de publicação:
Data Ahead of Print:
Autores da FMUP
Participantes de fora da FMUP
- 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
- Panés, J
- Peyrin-Biroulet, L
- Ran, ZH
- 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
- CORE-IBD Collaborators
Unidades de investigação
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.
Dados da publicação
- ISSN/ISSNe:
- 1528-0012, 0016-5085
- Tipo:
- Article
- Páginas:
- 950-964
- Link para outro recurso:
- www.scopus.com
Gastroenterology W.B. Saunders Ltd
Citações Recebidas na Web of Science: 22
Citações Recebidas na Scopus: 46
Documentos
- Não há documentos
Filiações
Keywords
- End Point; Crohn's Disease; Ulcerative Colitis; Outcomes
Financiamento
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Citar a publicação
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 L,Ran ZH,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 N,Feagan BG,Jairath V,CORE C. CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease. Gastroenterology. 2022. 163. (4):p. 950-964. IF:29,400. (1).
