Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN).
Abstract
Obesity continues to be a major public health issue, with more than two-thirds of
adults in the USA categorized as overweight or obese. Bariatric surgery is effective
and yields durable weight loss; however, few qualified candidates choose to undergo
surgical treatment. Less-invasive alternatives to bariatric surgery are being developed
to bridge the treatment gap. Recognizing the burden of conducting pivotal clinical
trials and traditional post-approval studies for medical devices, the Food and Drug
Administration (FDA) Center for Devices and Radiological Health has encouraged the
development of real-world data content and quality that is sufficient to provide evidence
for Total Product Life Cycle medical device evaluation. A key first step is to establish
a minimum core data structure that provides a common lexicon for endoscopic obesity
devices and its corresponding interoperable data elements. Such a structure would
facilitate data capture across existing workflow with a 'coordinated registry network'
capability. On July 29, 2016, a workshop entitled, 'GI Coordinated Registry Network:
A Case for Obesity Devices' was held at the FDA White Oak Campus by the Medical Device
Epidemiology Network public-private partnership and FDA to initiate the work of developing
a common lexicon and core data elements in the metabolic device space, which marked
the inauguration of the Gastrointestinal Coordinated Registry Network project. Several
work groups were subsequently formed to address clinical issues, data quality issues,
registry participation, and data sharing.
Type
Journal articleSubject
device approvaldevice evaluation
device surveillance
patient outcome assessment
real world evidence
Permalink
https://hdl.handle.net/10161/26249Published Version (Please cite this version)
10.1136/bmjsit-2021-000118Publication Info
Long, Cynthia; Tcheng, James E; Marinac-Dabic, Danica; Iorga, Andrea; Krucoff, Mitchell;
& Fisher, Deborah (2022). Developing minimum core data structure for the obesity devices Coordinated Registry
Network (CRN). BMJ surgery, interventions, & health technologies, 4(Suppl 1). pp. e000118. 10.1136/bmjsit-2021-000118. Retrieved from https://hdl.handle.net/10161/26249.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
Collections
More Info
Show full item recordScholars@Duke
Mitchell Wolfe Krucoff
Professor of Medicine
James Enlou Tcheng
Professor of Medicine
In addition to my clinical responsibilities as an interventional cardiologist, my
research interests include the study of antithrombotic therapies in cardiovascular
disease, clinical informatics, artificial intelligence, and information technology
systems. I have conducted and participated in numerous clinical trials, including
the EPIC, PROLOG, EPILOG, EPISTENT, IMPACT, IMPACT II, TOTAL, PRIDE, ESPRIT, MEND-1,
ELECT, and SUPPORT Trials. My areas of expertise are an
Alphabetical list of authors with Scholars@Duke profiles.

Articles written by Duke faculty are made available through the campus open access policy. For more information see: Duke Open Access Policy
Rights for Collection: Scholarly Articles
Works are deposited here by their authors, and represent their research and opinions, not that of Duke University. Some materials and descriptions may include offensive content. More info