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

Authors :
Cynthia Long
James E Tcheng
Danica Marinac-Dabic
Andrea Iorga
Mitchell Krucoff
Deborah Fisher
Source :
BMJ Surgery, Interventions, & Health Technologies. 4:e000118
Publication Year :
2022
Publisher :
BMJ, 2022.

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.

Subjects

Subjects :
Biomedical Engineering
Surgery

Details

ISSN :
26314940
Volume :
4
Database :
OpenAIRE
Journal :
BMJ Surgery, Interventions, & Health Technologies
Accession number :
edsair.doi.dedup.....3ef6824e7c8396094a590b2bc1cf26a2
Full Text :
https://doi.org/10.1136/bmjsit-2021-000118