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Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN).

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Date
2022-01
Authors
Long, Cynthia
Tcheng, James E
Marinac-Dabic, Danica
Iorga, Andrea
Krucoff, Mitchell
Fisher, Deborah
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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 article
Subject
device approval
device evaluation
device surveillance
patient outcome assessment
real world evidence
Permalink
https://hdl.handle.net/10161/26249
Published Version (Please cite this version)
10.1136/bmjsit-2021-000118
Publication 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.
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Scholars@Duke

Krucoff

Mitchell Wolfe Krucoff

Professor of Medicine
Tcheng

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
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