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. 2023 May 25;23(1):129.
doi: 10.1186/s12874-023-01944-2.

Development of the global inflammatory bowel disease visualization of epidemiology studies in the 21st century (GIVES-21)

Collaborators, Affiliations

Development of the global inflammatory bowel disease visualization of epidemiology studies in the 21st century (GIVES-21)

Joyce W Y Mak et al. BMC Med Res Methodol. .

Abstract

Background: There is a rapid increase in the incidence of inflammatory bowel diseases (IBD) in newly industrialized countries, yet epidemiological data is incomplete. We herein report the methodology adopted to study the incidence of IBD in newly industrialized countries and to evaluate the effect of environmental factors including diet on IBD development.

Methods: Global IBD Visualization of Epidemiology Studies in the 21st Century (GIVES-21) is a population-based cohort of newly diagnosed persons with Crohn's disease and ulcerative colitis in Asia, Africa, and Latin America to be followed prospectively for 12 months. New cases were ascertained from multiple sources and were entered into a secured online system. Cases were confirmed using standard diagnostic criteria. In addition, endoscopy, pathology and pharmacy records from each local site were searched to ensure completeness of case capture. Validated environmental and dietary questionnaires were used to determine exposure in incident cases prior to diagnosis.

Results: Through November 2022, 106 hospitals from 24 regions (16 Asia; 6 Latin America; 2 Africa) have joined the GIVES-21 Consortium. To date, over 290 incident cases have been reported. All patients have demographic data, clinical disease characteristics, and disease course data including healthcare utilization, medication history and environmental and dietary exposures data collected. We have established a comprehensive platform and infrastructure required to examine disease incidence, risk factors and disease course of IBD in the real-world setting.

Conclusions: The GIVES-21 consortium offers a unique opportunity to investigate the epidemiology of IBD and explores new clinical research questions on the association between environmental and dietary factors and IBD development in newly industrialized countries.

Keywords: Diet; Environmental; Incidence; Prevalence.

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Conflict of interest statement

Dr. Ng has received honoraria for speaking or consultancy for Janssen, Abbvie, Takeda, Ferring, Tilotts, Menarini, Pfizer. She has received research support from Olympus, Ferring, Janssen and Abbvie.

Dr. Kaplan has received honoraria for speaking or consultancy from AbbVie, Janssen, Pfizer,

91 Amgen, and Takeda. He has received research support from Ferring, Janssen, AbbVie, Glaxo Smith Kline, Merck, and Shire. He has been a consultant for Gilead. He shares ownership of a patent: TREATMENT OF INFLAMMATORY DISORDERS, AUTOIMMUNE DISEASE, AND PBC. UTI Limited Partnership, assignee. Patent WO2019046959A1. PCT/CA2018/051098. 7 Sept. 2018.

Dr. Bernstein is supported by the Bingham Chair in Gastroenterology. Dr. Bernstein has served on advisory Boards for AbbVie Canada, Amgen Canada, Bristol Myers Squibb Canada, Roche Canada, JAMP Pharmaceuticals Canada, Janssen Canada, Sandoz Canada, Takeda Canada, and Pfizer Canada; Consultant for Mylan Pharmaceuticals and Takeda; Educational grants from Abbvie Canada, Bristol Myers Squibb Canada \, Pfizer Canada, Takeda Canada, and Janssen Canada. Speaker’s panel for Abbvie Canada, Janssen Canada, Pfizer Canada, and Takeda Canada. Received research funding from Abbvie Canada and, Amgen Canada, Sandoz Canada, Takeda Canada, Pfizer Canada.

Dr. Kotze has received speaking and consultancy honorarium from Pfizer, Janssen, Takeda, Abbvie and Novartis. He also received scientific grants from Takeda and Pfizer

Dr. Gearry has received honoraria, consultancy, or research grants from AbbVie, Janssen, Celltrion, Takeda, Ferring and Zespri.

Dr. Yamamoto-Furusho has consulted or served on advisory boards for: AbbVie, Bristol Myers Squibb, Boehringer Ingelheim, Ferring pharmaceutical, Janssen, Pfizer and Takeda; Teaching, lecturing, or speaking: Abbvie, Carnot, Celltrion, Schering-Plough, Falk foundation, Ferring, Janssen, MSD, Pfizer, Takeda, UCB, Grants/Research Support: Shire, Bristol Myers, Celgene, Takeda.

Dr. Shu Chen Wei has consulted or served on advisory boards for: AbbVie, Celltrion, Ferring.

Pharmaceuticals Inc., Gilead, Janssen, Pfizer, Takeda, and Tanabe and receives lecture fees from AbbVie, Bristol Myers Squibb, Celltrion, Excelsior Biopharma Inc., Ferring Pharmaceuticals Inc., Janssen, Takeda, Tanabe.

Dr. Paulo G. Kotze has received speaking and consultancy honorarium from Pfizer, Janssen, Takeda, AbbVie, and Novartis, and also has received scientific grants from Takeda and Pfizer.

Dr. Maria T. Abreu has consulted or served on advisory boards or as a consultant for AbbVie Inc, Arena Pharmaceuticals, Bristol Myers Squibb, Celsius, Eli Lilly Pharmaceuticals, Gilead, Helmsley Charitable Trust, Janssen, Microba, Pfizer, Prometheus Biosciences, UCB Biopharma, WebMD Global LLC and has served as a speaker for Alimentiv, Janssen, Prime CME, and Takeda Pharmaceuticals.

Dr. David Rubin has received grant support from Takeda, and has served as a consultant for Abbvie, Altrubio, Aslan Pharmaceuticals, Athos Therapeutics, Bellatrix Pharmaceuticals, Boehringer Ingelheim, Ltd., Bristol-Myers Squibb, Celgene Chronicles, Corp/Syneos, ClostraBio, Connect BioPharma, Eco R1, Genentech/Roche, Gilead Sciences, Iterative Health, Janssen Pharmaceuticals, Kaleido Biosciences, Lilly, Pfizer, Prometheus Biosciences, Reistone, Seres Therapeutics, Takeda, Target RWE, and Trellus Health.

Dr. Iris Dotan has received grant support from BMS and Altman Research and has served as a consultant/advisor/speaker to Abbvie, Abbott, Athos, Arena, BMS/Celgene, Celltrion, Cambridge Healthcare, Eli-Lilly, Falk Pharma, Food Industries Organization, Gilead, Galapagos, Genentech/Roche, Iterative Scopes, Integra Holdings, Janssen, Neopharm, Pfizer, Rafa Laboratories, Sublimity, Sangamo, Takeda, Wilbio, Dr. Panu Wetwittayakhlang M.D. has been a speaker and/or advisory board member: Takeda, Pfizer, Janssen, Ferring, A. Menerini, and MSD.

No conflict of interests for other authors.

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