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

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...

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Autores principales: Long, Cynthia, Tcheng, James E, Marinac-Dabic, Danica, Iorga, Andrea, Krucoff, Mitchell, Fisher, Deborah
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9660582/
https://www.ncbi.nlm.nih.gov/pubmed/36393892
http://dx.doi.org/10.1136/bmjsit-2021-000118
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author Long, Cynthia
Tcheng, James E
Marinac-Dabic, Danica
Iorga, Andrea
Krucoff, Mitchell
Fisher, Deborah
author_facet Long, Cynthia
Tcheng, James E
Marinac-Dabic, Danica
Iorga, Andrea
Krucoff, Mitchell
Fisher, Deborah
author_sort Long, Cynthia
collection PubMed
description 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.
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spelling pubmed-96605822022-11-15 Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN) Long, Cynthia Tcheng, James E Marinac-Dabic, Danica Iorga, Andrea Krucoff, Mitchell Fisher, Deborah BMJ Surg Interv Health Technol Analysis 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. BMJ Publishing Group 2022-11-11 /pmc/articles/PMC9660582/ /pubmed/36393892 http://dx.doi.org/10.1136/bmjsit-2021-000118 Text en © Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Analysis
Long, Cynthia
Tcheng, James E
Marinac-Dabic, Danica
Iorga, Andrea
Krucoff, Mitchell
Fisher, Deborah
Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN)
title Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN)
title_full Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN)
title_fullStr Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN)
title_full_unstemmed Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN)
title_short Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN)
title_sort developing minimum core data structure for the obesity devices coordinated registry network (crn)
topic Analysis
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9660582/
https://www.ncbi.nlm.nih.gov/pubmed/36393892
http://dx.doi.org/10.1136/bmjsit-2021-000118
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