Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN)
| dc.contributor.author | Long, Cynthia | |
| dc.contributor.author | Tcheng, James E | |
| dc.contributor.author | Marinac-Dabic, Danica | |
| dc.contributor.author | Iorga, Andrea | |
| dc.contributor.author | Krucoff, Mitchell | |
| dc.contributor.author | Fisher, Deborah | |
| dc.date.accessioned | 2022-12-09T20:00:14Z | |
| dc.date.available | 2022-12-09T20:00:14Z | |
| dc.date.issued | 2022-11-14 | |
| dc.description.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. | en_US |
| dc.description.sponsorship | Partially supported by The Assistant Secretary for Planning and Evaluation (ASPE) and Patient-Centered Outcomes Research Trust Fund (PCORTF) of the U.S. Department of Health and Human Services under Interagency Agreement #750119PE060048, through the U.S. Food and Drug Administration (FDA) Grant 5U01FD005478. | en_US |
| dc.description.uri | https://sit.bmj.com/content/4/Suppl_1/e000118 | en_US |
| dc.format.extent | 5 pages | en_US |
| dc.genre | journal articles | en_US |
| dc.identifier | doi:10.13016/m2agyi-kx4x | |
| dc.identifier.citation | Long C, Tcheng JE, Marinac-Dabic D, et al. Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN). BMJ Surg Interv Health Technologies 2022;4:e000118. doi:10.1136/ bmjsit-2021-000118 | en_US |
| dc.identifier.uri | http://dx.doi.org/10.1136/bmjsit-2021-000118 | |
| dc.identifier.uri | http://hdl.handle.net/11603/26429 | |
| dc.language.iso | en_US | en_US |
| dc.publisher | BMJ | en_US |
| dc.relation.isAvailableAt | The University of Maryland, Baltimore County (UMBC) | |
| dc.relation.ispartof | UMBC Center for Accelerated Real Time Analysis | |
| dc.relation.ispartof | UMBC Faculty Collection | |
| dc.rights | This work was written as part of one of the author's official duties as an Employee of the United States Government and is therefore a work of the United States Government. In accordance with 17 U.S.C. 105, no copyright protection is available for such works under U.S. Law. | en_US |
| dc.rights | Public Domain Mark 1.0 | * |
| dc.rights.uri | http://creativecommons.org/publicdomain/mark/1.0/ | * |
| dc.title | Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN) | en_US |
| dc.type | Text | en_US |
| dcterms.creator | https://orcid.org/0000-0001-7809-9184 | en_US |