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.

Maturity framework and select approaches for developing Coordinated Registry Networks (CRNs): Medical Device Epidemiology Network (MDEpiNet) supplement

“…Using a majority voting method, core data elements were identified with relevant device characteristics, clinical information, and outcomes important for safety and effectiveness evaluations. 13 …”

“…The next six papers in this supplement summarise the collaborative work of MDEpiNet in the past several years that helped select CRNs to develop data capacity and infrastructure. [11][12][13][14][15][16] CRNs were tailored to the clinical context as well as the available resources to provide an efficient platform for device performance evaluation. The stakeholder alignment provided registry leaders early insights into the potential challenges Open access and paths for the successful development of CRN.…”

“…Using a majority voting method, core data elements were identified with relevant device characteristics, clinical information, and outcomes important for safety and effectiveness evaluations. 13 Women's health technologies (WHT) CRN, launched in 2017, has successfully developed the capacity in evaluating surgical devices used in women's reproductive health. The CRN has established core data elements in pelvic organ prolapse (POP), uterine fibroids (UF), and long-acting and permanent contraception with the help of collaborations with national registries like The American Urogynecologic Society Community for Quality Improvement Using Real-world Evidence (ACQUIRE) and Comparing Options for Management: Patient-centred Results of UF (COMPARE-UF).…”

“…The next six papers in this supplement summarise the collaborative work of MDEpiNet in the past several years that helped select CRNs to develop data capacity and infrastructure 11–16. CRNs were tailored to the clinical context as well as the available resources to provide an efficient platform for device performance evaluation.…”

“…The data sources for establishing core data elements included existing literature, case report forms, and instruments from the American College of Surgeons Metabolic and Bariatric Surgery Accreditation and Quality Improvement registry. Using a majority voting method, core data elements were identified with relevant device characteristics, clinical information, and outcomes important for safety and effectiveness evaluations 13…”