Browsing by Author "Tcheng, James E"

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Open Access
Achieving Data Liquidity: Lessons Learned from Analysis of 38 Clinical Registries (The Duke-Pew Data Interoperability Project.
(AMIA ... Annual Symposium proceedings. AMIA Symposium, 2019-01) Tcheng, James E; Drozda, Joseph P; Gabriel, Davera; Heath, Anne; Wilgus, Rebecca W; Williams, Mary; Windle, Thomas A; Windle, John R
BACKGROUND:To assess the current state of clinical data interoperability, we evaluated the use of data standards across 38 large professional society registries. METHODS:The analysis included 4 primary components: 1) environmental scan, 2) abstraction and cross-tabulation of clinical concepts and corresponding data elements from registry case report forms, dictionaries, and / or data models, 3) cross-tabulation of same across national common data models, and 4) specifying data element metadata to achieve native data interoperability. RESULTS:The registry analysis identified approximately 50 core clinical concepts. None were captured using the same data representation across all registries, and there was little implementation of data standards. To improve technical implementation, we specified 13 key metadata for each concept to be used to achieve data consistency. CONCLUSION:The registry community has not benefitted from and does not contribute to interoperability efforts. A common, authoritative process to specify and implement common data elements is greatly needed.
Open Access
Developing minimum core data structure for the obesity devices Coordinated Registry Network (CRN).
(BMJ surgery, interventions, & health technologies, 2022-01) Long, Cynthia; Tcheng, James E; Marinac-Dabic, Danica; Iorga, Andrea; Krucoff, Mitchell; Fisher, Deborah
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.
Open Access
Relationship Between Cancer and Cardiovascular Outcomes Following Percutaneous Coronary Intervention.
(J Am Heart Assoc, 2015-07-06) Hess, Connie N; Roe, Matthew T; Clare, Robert M; Chiswell, Karen; Kelly, Joseph; Tcheng, James E; Hagstrom, Emil; James, Stefan K; Khouri, Michel G; Hirsch, Bradford R; Kong, David F; Abernethy, Amy P; Krucoff, Mitchell W
BACKGROUND: Cardiovascular disease and cancer increasingly coexist, yet relationships between cancer and long-term cardiovascular outcomes post-percutaneous coronary intervention (PCI) are not well studied. METHODS AND RESULTS: We examined stented PCI patients at Duke (1996-2010) using linked data from the Duke Information Systems for Cardiovascular Care and the Duke Tumor Registry (a cancer treatment registry). Our primary outcome was cardiovascular mortality. Secondary outcomes included composite cardiovascular mortality, myocardial infarction, or repeat revascularization and all-cause mortality. We used adjusted cause-specific hazard models to examine outcomes among cancer patients (cancer treatment pre-PCI) versus controls (no cancer treatment pre-PCI). Cardiovascular mortality was explored in a cancer subgroup with recent (within 1 year pre-PCI) cancer and in post-PCI cancer patients using post-PCI cancer as a time-dependent variable. Among 15 008 patients, 3.3% (n=496) were cancer patients. Observed rates of 14-year cardiovascular mortality (31.4% versus 27.7%, P=0.31) and composite cardiovascular death, myocardial infarction, or revascularization (51.1% versus 55.8%, P=0.37) were similar for cancer versus control groups; all-cause mortality rates were higher (79.7% versus 49.3%, P<0.01). Adjusted risk of cardiovascular mortality was similar for cancer patients versus controls (hazard ratio 0.95; 95% CI 0.76 to 1.20) and for patients with versus without recent cancer (hazard ratio 1.46; 95% CI 0.92 to 2.33). Post-PCI cancer, present in 4.3% (n=647) of patients, was associated with cardiovascular mortality (adjusted hazard ratio 1.51; 95% CI 1.11 to 2.03). CONCLUSIONS: Cancer history was present in a minority of PCI patients but was not associated with worse long-term cardiovascular outcomes. Further investigation into PCI outcomes in this population is warranted.