CORE-IBD: A Multidisciplinary International Consensus Initiative to Develop a Core Outcome Set for Randomized Controlled Trials in Inflammatory Bowel Disease.
Christopher Ma,Jurij Hanžel,Remo Panaccione,William J. Sandborn,Geert R. D'Haens,Vineet Ahuja,Raja Atreya,Charles N. Bernstein,Peter Bossuyt,Brian Bressler,Robert V Bryant,Benjamin L Cohen,Jean-Frederic Colombel,Silvio Danese,Axel Dignass,Marla Dubinsky,Phillip Fleshner,Richard B. Gearry,Stephen B. Hanauer,Ailsa Hart,Paulo Gustavo Kotze,Torsten Kucharzik,Peter L. Lakatos,Rupert W. Leong,Fernando Magro,Julián Panés,Laurent Peyrin-Biroulet,Zhihua Ran,Miguel Regueiro,Siddharth Singh,Antonino Spinelli,A. Hillary Steinhart,Simon Travis,C. Janneke van der Woude,Bruce R. Yacyshyn,Takayuki Yamamoto,Matthieu Allez,Willem A. Bemelman,Amy L. Lightner,Edouard Louis,David T. Rubin,Ellen Scherl,Corey A. Siegel,Mark S. Silverberg,Severine Vermeire,Claire E Parker,S. Mcfarlane,Leonardo Guizzetti,Michelle I. Smith,Niels Vande Casteele,Brian G. Feagan,Vipul Jairath +51 more
TL;DR: This multidisciplinary collaboration involving patients and clinical experts has produced the first COS that can be applied to RCTs of Crohn's disease and UC.
read more
About: This article is published in Gastroenterology. The article was published on 01 Jul 2022. and is currently open access. The article focuses on the topics: Medicine & Medicine.
read more
Chat with Paper
AI Agents for this Paper
Find similar papers on Google Scholar, PubMed and Arxiv
Write a critical review of this paper
Analyze citations of this paper to find unaddressed research gaps
Citations
Bowel Urgency in Ulcerative Colitis: Current Perspectives and Future Directions.
Marla Dubinsky,Alison Potts Bleakman,Remo Panaccione,Toshifumi Hibi,Stefan Schreiber,David T. Rubin,Axel Dignass,Isabel Redondo,TH Gibble,C. Kayhan,Simon Travis +10 more
TL;DR: In this paper , the authors discuss the pathophysiology and clinical importance of bowel urgency in ulcerative colitis and its impact on quality of life and psychosocial functioning.
19
Disease Clearance as a New Outcome in Ulcerative Colitis: a Systematic Review and Expert Consensus.
Ferdinando D'Amico,Fernando Magro,Britta Siegmund,Taku Kobayashi,Paulo Gustavo Kotze,Virginia Solitano,Bénédicte Caron,Sameer Al Awadhi,Ailsa Hart,Vipul Jairath,Axel Dignass,Laurent Peyrin-Biroulet,Silvio Danese +12 more
TL;DR: A systematic review found the role of disease clearance, defined as a composite outcome including simultaneous clinical, endoscopic, and histologic remission of disease in the management of patients with UC, to be a potential target in ulcerative colitis.
14
Modified Mayo score versus Mayo score for evaluation of treatment efficacy in patients with ulcerative colitis: data from the tofacitinib OCTAVE program
William J. Sandborn,Bruce E. Sands,Severine Vermeire,Yvette Leung,Xiang Guo,Irene Modesto,Chinyu Su,Wenjin Wang,Julián Panés +8 more
TL;DR: In this article , the authors compared treatment efficacy using endpoint definitions based on modified Mayo (mMayo) score, versus those based on Mayo score, using data from the tofacitinib OCTAVE program.
12
Current and emerging biomarkers for ulcerative colitis.
J. K. Nowak,Rahul Kalla,J. Satsangi +2 more
TL;DR: The use of established biomarkers is discussed, along with new evidence regarding autoantibodies, proteins, proteomic panels, transcriptomic signatures, deoxyribonucleic acid methylation patterns, and UC-specific glycomic and metabolic disturbances.
11
Development of a Core Outcome Set for Real-World Data in Inflammatory Bowel Disease: A European Crohn's and Colitis Organisation (ECCO) Position Paper.
Jurij Hanžel,Patrick M.M. Bossuyt,Valérie Pittet,Mark A Samaan,Monika Tripathi,Wladyslawa Czuber-Dochan,Johan Burisch,S Leone,R Saldaña,Filip Baert,Uri Kopylov,Susanna Jäghult,Michel Adamina,Naila Arebi,Krisztina Gecse +14 more
TL;DR: A core outcome set for real- world studies in IBD has been developed based on international multidisciplinary consensus and its adoption will facilitate synthesis in the generation of real-world evidence.
10
References
GRADE guidelines: 2. Framing the question and deciding on important outcomes
Gordon H. Guyatt,Andrew D Oxman,Regina Kunz,David C. Atkins,Jan Brozek,Gunn Elisabeth Vist,Philip Alderson,Paul Glasziou,Yngve Falck-Ytter,Holger J. Schünemann +9 more
TL;DR: In considering the importance of a surrogate outcome, authors should rate the importanceof the patient-important outcome for which the surrogate is a substitute and subsequently rate down the quality of evidence for indirectness of outcome.
1.6K
STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD
Dan Turner,Amanda Ricciuto,Ayanna Lewis,Ferdinando D'Amico,Jasbir Dhaliwal,Anne M. Griffiths,Dominik Bettenworth,William J. Sandborn,Bruce E. Sands,Walter Reinisch,Jürgen Schölmerich,Willem A. Bemelman,Silvio Danese,Jean Yves Mary,David T. Rubin,Jean-Frederic Colombel,Laurent Peyrin-Biroulet,Iris Dotan,Maria T. Abreu,Axel Dignass +19 more
TL;DR: In a recent survey of 89 members of the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD), a systematic review of the literature and iterative surveys of 89 IOIBD members, recommendations were drafted and modified in 2 surveys and 2 voting rounds as mentioned in this paper.
1.6K
The COMET Handbook: Version 1.0
Paula R Williamson,Douglas G. Altman test,Heather Bagley,Karen L. Barnes,Jane M Blazeby,Sara T Brookes,Mike Clarke,Mike Clarke,Elizabeth Gargon,Sarah L. Gorst,Nicola Harman,Jamie J Kirkham,Angus G K McNair,Cecilia A.C. Prinsen,Jochen Schmitt,Caroline B. Terwee,Bridget Young +16 more
TL;DR: A four-step process to develop a core outcome set is recommended, an agreed standardised collection of outcomes which should be measured and reported, as a minimum, in all trials for a specific clinical area.
Developing core outcome sets for clinical trials: issues to consider.
Paula R Williamson,Douglas G. Altman test,Jane M Blazeby,Mike Clarke,Declan Devane,Elizabeth Gargon,Peter Tugwell +6 more
TL;DR: The need for general guidance on the development of core outcome sets, which should be measured and reported, as a minimum, in all trials for a specific clinical area, is identified.
1.5K
ECCO-ESGAR Guideline for Diagnostic Assessment in IBD Part 1: Initial diagnosis, monitoring of known IBD, detection of complications
Christian Maaser,Andreas Sturm,Stephan R. Vavricka,Torsten Kucharzik,Gionata Fiorino,Vito Annese,Emma Calabrese,Daniel C. Baumgart,Dominik Bettenworth,Paula Borralho Nunes,Johan Burisch,Fabiana Castiglione,Rami Eliakim,Pierre Ellul,Yago Gonzalez-Lama,Hannah Gordon,Steve Halligan,Konstantinos Katsanos,Uri Kopylov,Paulo Gustavo Kotze,Eduards Krustins,Andrea Laghi,Jimmy K. Limdi,Florian Rieder,Jordi Rimola,Stuart A. Taylor,Damian Tolan,Patrick F. van Rheenen,Bram Verstockt,Jaap Stoker +29 more
TL;DR: Christian Maaser, a Andreas Sturm,b Stephan R. Vavricka,c Torsten Kucharzik,d Gionata Fiorino,e Vito Annese,f Emma Calabrese,f Daniel C. Baumgart,h Dominik Bettenworth,i Paula Borralho Nunes,j, Johan Burisch,k, Fabiana Castiglione,l Rami Eliakim,m Pierre Ellul,n Yago Gonz
1.3K