Developing and applying common data elements to enhance clinical and translational research, healthcare access and outcomes in inflammatory bowel disease

NIH RePORTER · NIH · U24 · $491,500 · view on reporter.nih.gov ↗

Abstract

ABSTRACT The inflammatory bowel diseases (IBD) are comprised equally of two major subtypes, Crohn's disease and ulcerative colitis, with a peak age of onset between 15-30 years of age. As for many immune-mediated inflammatory diseases (IMID), IBD incidence is rising world-wide, especially among diverse populations. Although IBD prevalence in LatinX and Black populations in North America is lower, compared to European ancestry populations, outcomes are often worse, for myriad reasons, including diagnostic delays and reduced access to care and disease-modifying treatments. The NIDDK IBD Genetics Consortium (IBDGC) was established in 2002, with the major goal of developing a thorough understanding of the genetic structure of IBD to elucidate the pathophysiology of IBD for improved patient outcomes. The NIDDK IBDGC is comprised of 7 Genetics Research Centers (GRCs) sited at major IBD centers in the United States and Canada, and a Data Coordinating Center (DCC). Biospecimens, immortalized cell lines and phenotypic and genomic datasets from the IBDGC are available via the NIDDK Central Repository and dbGaP. The IBDGC also acts as a coordinating center for the International IBD Genetics Consortium. The major priority of the IBDGC during the current funding period (2022-2027) is to enhance recruitment of LatinX and Black IBD cohorts, for both social justice and scientific reasons. The NIDDK IBDGC has developed protocols and workflows to enhance diverse patient recruitment throughout North America (including direct to patient), reaching beyond highly resourced IBD-specialized centers. Common data elements (CDEs) for IBD do not currently exist. Therefore, in this supplement request, the IBDGC DCC, in collaboration with the University of Miami GRC and with other IBDGC investigators, is proposing development of IBD-related CDEs for submission to the NIH CDE Repository, NIH endorsement and dissemination. CDE development will leverage extant forms developed by the NIDDK IBDGC. Form-based, research-focused CDEs will be integrated with major model-based research and clinical care, such as HL7/FHIR, PheCodes, LOINC and OMOP structures, with harmonization and validation between two major health systems, the University of Miami and the Icahn School of Medicine at Mount Sinai, New York. CDEs and form-based models directed toward patient - primary care provider - general gastroenterologist - IBD specialist referral efficiencies will be developed. CDEs will provide the building blocks by which AI-assisted forms and models can be developed for patients, primary care providers, general gastroenterologists and IBD subspecialty centers. Development of CDEs for IBD will enhance clinical and translational research in IBD, facilitate recruitment among diverse populations, enhance opportunities for collaboration and allow extant IBD resources to be more fully leveraged, such as the lymphoblastoid cell lines, other biospecimens and matched genetic and phenotypic data deposited...

Key facts

NIH application ID
11159202
Project number
3U24DK062429-25S1
Recipient
ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
Principal Investigator
JUDY H. CHO
Activity code
U24
Funding institute
NIH
Fiscal year
2024
Award amount
$491,500
Award type
3
Project period
2024-07-01 → 2025-06-30