James E Tcheng’s research while affiliated with Duke University and other places

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Publications (412)


Pulse Oximetry equipment categories and examples
Example device images are included in S2 Fig.
The high price of equity in pulse oximetry: A cost evaluation and need for interim solutions
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September 2024

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1 Citation

Katelyn Dempsey

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Disparities in pulse oximetry accuracy, disproportionately affecting patients of color, have been associated with serious clinical outcomes. Although many have called for pulse oximetry hardware replacement, the cost associated with this replacement is not known. The objective of this study was to estimate the cost of replacing all current pulse oximetry hardware throughout a hospital system via a single-center survey in 2023 at an academic medical center (Duke University) with three hospitals. The main outcome was the cost of total hardware replacement as identified by current day prices for hardware. New and used prices for 3,542/4,136 (85.6%) across three hospitals for pulse oximetry devices were found. The average cost to replace current pulse oximetry hardware is 6,834.61perbed.Replacementandintegrationcostsareestimatedat6,834.61 per bed. Replacement and integration costs are estimated at 14.2–17.4 million for the entire medical system. Extrapolating these costs to 5,564 hospitals in the United States results in an estimated cost of $8.72 billion. “Simply replacing” current pulse oximetry hardware to address disparities may not be simple, cheap, or timely. Solutions for addressing pulse oximetry accuracy disparities leveraging current technology may be necessary, and might also be better. Trial Registration: Pro00113724, exempt.

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Velocity profile of fluid flow through a cylinder.⁵ Lower left panel: no-slip boundary condition. Middle left panel: partial slip. Upper left panel: perfect slip. True slip (upper right panel) indicates the slip layer at the boundary is of molecular dimension, and effective (or apparent) slip (lower right panel) indicates the local velocity varies over a finite, albeit small, mesoscopic distance. Fluid flow is in the z-direction, steady, laminar and incompressible. R = cylinder inside radius; uR = fluid velocity at cylinder inside surface (“slip velocity”); umax = maximum flow velocity.
Representative illustrations from the validated model of platelet slip at vascular stenosis and near PCI device surfaces.⁵ Platelets were modeled using 3.12 μm diameter polystyrene (non-adhesive) microspheres. The model test section was cylindrical, flow was continuous, and the view presented is longitudinal of the horizontal middle plane. The velocities of the microspheres were determined by laser-Doppler velocimetry (blue rings and discs: ○;●). These velocities were compared with COMSOL Multiphysics computer-simulations of plasma velocity profiles (black solid lines). The model had the capacity to insert a central solid cylinder to model a PCI guide wire (a “cylinder-within-a-cylinder”). The was 20–90% by cross sectional area. The Reynolds number of 300 is within the range of coronary flow.²⁵ All velocities were normalized to the mean velocity u0, calculated from direct volumetric measurement of bulk fluid flow. Computer simulations applied the no-slip boundary condition at each surface, noting wall shear stresses in the unobstructed coronary circulation promote minimal plasma slip.⁵⁶ The blue discs (●) highlight partial or effective slip (i.e.: non-zero velocity) of microspheres immediately adjacent to the surfaces of the stenoses and central cylinder surface. PCI = percutaneous coronary intervention.
Comparison of perfused whole blood platelet adhesion to collagen (% Area covered) at shear rates 1000 –10 000 sec⁻¹ with no inhibitors, VHH81 (14 μg/mL) or ARC1172 (1 μM) mixed with recalcified blood before perfusion.¹² Comparison between platelet coverage [adhesion] was analyzed with a two-way ANOVA with mixed effects and Tukey’s multiple comparison correction. p values after multiple comparison corrections are displayed for relevant groups. Data are means±standard deviation with n = number of fields analyzed per condition. Reproduced with permission.
Effect of shear rate on platelets at a PCI device surface (upper panel)⁵ and at a site of endothelial disruption (lower panel). Left-low shear; Right-high shear.
Translating proof-of-concept for platelet slip into improved antithrombotic therapeutic regimens

Platelets are central to thrombosis. Research at the intersection of biological and physical sciences provides proof-of-concept for shear rate-dependent platelet slip at vascular stenosis and near device surfaces. Platelet slip extends the observed biological “slip-bonds” to the boundary of functional gliding without contact. As a result, there is diminished engagement of the coagulation cascade by platelets at these surfaces. Comprehending platelet slip would more precisely direct antithrombotic regimens for different shear environments, including for percutaneous coronary intervention (PCI). In this brief report we promote translation of the proof-of-concept for platelet slip into improved antithrombotic regimens by: (1) reviewing new supporting basic biological science and clinical research for platelet slip; (2) hypothesizing the principal variables that affect platelet slip; (3) applying the consequent construct model in support of-and in some cases to challenge-relevant contemporary guidelines and their foundations (including for urgent, higher-risk PCI); and (4) suggesting future research pathways (both basic and clinical). Should future research demonstrate, explain and control platelet slip, then a paradigm shift for choosing and recommending antithrombotic regimens based on predicted shear rate should follow. Improved clinical outcomes with decreased complications accompanying this paradigm shift for higher-risk PCI would also result in substantive cost savings.



National estimates in fleet replacement cost, using different hospital types for estimates, using 75% used/new price estimates This table reflects the extrapolated cost of replacing pulse oximetry equipment for all 5,564 hospitals in the 2015 CDC hospital data chart. This model explores a range of costs for replacing pulse oximetry per bed from a quaternary academic medical center (hospital A) through community hospitals (B, C). This does not include integration costs.for use under a CC0 license.
The High Price of Equity in Pulse Oximetry: A cost evaluation and need for interim solutions

September 2023

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42 Reads

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3 Citations

Importance: Disparities in pulse oximetry accuracy, disproportionately affecting patients of color, have been associated with serious clinical outcomes. Although many have called for pulse oximetry hardware replacement, the cost associated with this replacement is not known. Objective: To estimate the cost of replacing all pulse oximetry hardware throughout a hospital system. Design: Single-center survey, 2023 Setting: Single center. Participants: One academic medical center with three hospitals. Main Outcomes and Measures: Cost of fleet replacement as identified by current day prices for hardware. Results: New and used prices for 5,079/5,678 (89.5%) across three hospitals for pulse oximetry devices were found. The average equipment cost to replace pulse oximetry hardware is 15,704.12perbed.Replacementandintegrationcostsareestimatedat15,704.12 per bed. Replacement and integration costs are estimated at 28.5-31.8 million for the entire medical system. Extrapolating these costs to 5,564 hospitals in the United States results in an estimated cost of $14.1 billion. Conclusions and Relevance: “Simply replacing” pulse oximetry hardware to address disparities may be neither simple, cheap, or timely. Solutions for addressing pulse oximetry accuracy disparities leveraging current technology may be necessary.


Consensus Minimum Core Data Elements Adapted to Peripheral Vascular Intervention in the Drug-Eluting Era: Consensus Report from the Registry Assessment of Peripheral Interventional Devices (RAPID) Pathways “Lean” Working Group

July 2023

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15 Reads

Journal of Vascular Surgery

RAPID initiated the Pathways Program to provide a transparent, collaborative forum in which to pursue insights into multiple unresolved questions on benefit-risk of Paclitaxel Coated Devices, including understanding the basis of the mortality signal, without a demonstrable potential biological mechanism, and whether the late mortality signal could be artifact intrinsic to multiple independent prospective randomized data sources that did not pre-specify death as a long-term endpoint. In response to the directive, the LEAN-Case Report Form (LEAN-CRF) Working Group focused on enhancements to the RAPID Phase I Minimum Core Data set through the addition of key clinical modifiers that would be more strongly linked to longer-term mortality outcomes after PAD intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined.


Patient Registries for Clinical Research

June 2023

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23 Reads

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1 Citation

Patient registries are fundamental to biomedical research. Registries provide consistent, curated data about defined populations and can be used to support the study of the determinants and manifestations of disease and provide a picture of the natural history, outcomes of treatment, and experiences of individuals with a given condition or exposure. It is anticipated that electronic health record (EHR) systems will evolve to capture detailed clinical and patient-reported data that supports observational, and ultimately interventional, research. Emerging data representation and exchange standards can enable the interoperability required for automated transmission of clinical data into patient registries. This chapter describes informatics principles and approaches relevant to the design and implementation of patient registries, with emphasis on the ingestion of clinical data and the role of patient registries in research and learning health activities.KeywordsPatient registriesRegistriesClinical researchSecondary data useObservational research methodsObservational research studiesData standardsInteroperabilityData curationOutcomes measurementLearning health systems



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

November 2022

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15 Reads

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5 Citations

BMJ Surgery Interventions & Health Technologies

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.


Figure 2 Vascular Implant Surveillance and Interventional Outcomes Network coordinated registry network. The center hexagon depicts the role of the MDEpiNet Coordinating Centre, and outer hexagons represent various data partners and data sources. CDRN, Clinical Data Research Network; DUA, data use agreement; MOU, memorandum of understanding; OPC, Objective Performance Criteria; OPG, Objective Perfomance Goals; PCORI, Patient-Centered Outcomes Research Institute; SPARCS, Statewide Planning and Research Cooperative System; VQI, Vascular Quality Initiative. by copyright.
Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks

November 2022

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70 Reads

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13 Citations

BMJ Surgery Interventions & Health Technologies

Objectives Generating and using real-world evidence (RWE) is a pragmatic solution for evaluating health technologies. RWE is recognized by regulators, health technology assessors, clinicians, and manufacturers as a valid source of information to support their decision-making. Well-designed registries can provide RWE and become more powerful when linked with electronic health records and administrative databases in coordinated registry networks (CRNs). Our objective was to create a framework of maturity of CRNs and registries, so guiding their development and the prioritization of funding. Design, setting, and participants We invited 52 stakeholders from diverse backgrounds including patient advocacy groups, academic, clinical, industry and regulatory experts to participate on a Delphi survey. Of those invited, 42 participated in the survey to provide feedback on the maturity framework for CRNs and registries. An expert panel reviewed the responses to refine the framework until the target consensus of 80% was reached. Two rounds of the Delphi were distributed via Qualtrics online platform from July to August 2020 and from October to November 2020. Main outcome measures Consensus on the maturity framework for CRNs and registries consisted of seven domains (unique device identification, efficient data collection, data quality, product life cycle approach, governance and sustainability, quality improvement, and patient-reported outcomes), each presented with five levels of maturity. Results Of 52 invited experts, 41 (79.9%) responded to round 1; all 41 responded to round 2; and consensus was reached for most domains. The expert panel resolved the disagreements and final consensus estimates ranged from 80.5% to 92.7% for seven domains. Conclusions We have developed a robust framework to assess the maturity of any CRN (or registry) to provide reliable RWE. This framework will promote harmonization of approaches to RWE generation across different disciplines and health systems. The domains and their levels may evolve over time as new solutions become available.


Citations (71)


... Всё это привело к более низкой, чем ожидалось, статистике надёжности между оценщиками и процентным рейтингам согласия для нескольких неструктурированных элементов данных. При дальнейших исследованиях стало ясно, что дальнейшее применение стандартной методологии абстракции становится нецелесообразным [9]. ...

Reference:

Particular qualities of evaluation of electronic card data in modern healthcare
Assessing Real-World Data From Electronic Health Records for Health Technology Assessment: The SUITABILITY Checklist: A Good Practices Report of an ISPOR Task Force
  • Citing Article
  • June 2024

Value in Health

... Artificial intelligence (AI), as a recent advance in medicine, has an important role in supporting decision-making by clinicians. AI is now increasingly applied for disease risk 194 estimation, imaging and diagnostic modalities, precision medicine, and drug production. AI was introduced into surgery through image processing and navigation techniques and feature detection and computerized intervention for preoperative planning and intraoperative assistance. ...

Artificial Intelligence, Computational Simulations, and Extended Reality in Cardiovascular Interventions

JACC Cardiovascular Interventions

... Registry networks themselves are shown variable with respect towards data quality as well as patient engagement [22][23][24]. Additionally, there is a great amount of discussion surrounding the development of frameworks to assess the maturity of registry networks to provide RWE and highlight the need for the FDA to mandate evidence review combining RWE with traditional randomized clinical trials [9,11,25,26]. Despite these challenges, the interest in how to utilize the massive amount of post market evaluation data to better provide safe and effective medical devices is still great. ...

Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks

BMJ Surgery Interventions & Health Technologies

... Authorship should be a consideration for data generators when sharing is mandated. [17][18][19]23 This does not mean automatic authorship but a system that facilitates and requires communication between data generators and data users. This system should distinguish between expert (longitudinal study, novel or complex lab assay) and RWD data generation. ...

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

BMJ Surgery Interventions & Health Technologies

... The new clinical research supporting platelet slip is twofold: First, a retrospective study of antiplatelet therapy only, without anticoagulation, for urgent, higher-risk PCI; 15 and second, a randomized trial comparing antiplatelet therapies without anticoagulation for the treatment of acute ischemic stroke (AIS). 16 The PCI study 15 consisted of 481 consecutive patients receiving an antithrombotic regimen of antiplatelet therapy only (oral aspirin, P2Y 12 inhibitor; intravenous GPIIb-IIIa inhibitor), without anticoagulation. ...

Antiplatelet therapy only, without anticoagulation, for percutaneous coronary intervention: A translational application of platelet slip

Journal of Translational Science

... Law label medical devices with a unique device identifier (UDI) (Unique Device Identification 2013) as a necessary step to support better device tracking, as well as to support hospital supply chain operations, patient safety, and research, particularly for implantable devices (McClellan, Gardina, Daniel, et al. 2014;The Pew Charitable Trusts 2015;N. A. Wilson et al. 2022). The UDI consists of a two-part numeric code consisting of the device identifier (DI) and production identifier (PI), and since 2013, similar UDI frameworks have been announced by the European Union and 10 other countries. Although the FDA established a timeline for all devices to be compliant with its rule by 2022, barriers to implemen ...

Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers

... Several hospital systems have reported success in tracking implants in areas such as cardiac catheterization laboratories where sterile, UDI-labeled implants tend to be barcode-scannable at the point-of-care (POC) (Drozda, Dudley, Helmering, et al. 2015;Drozda, Graham, Muhlestein, et al. 2022;Krupka, Graham, Wilson, et al. 2021). Perhaps the most significant barrier to universal UDI tracking, however, is the impracticability of labeling extremely small devices, such as small and mini fragment implants used in orthopedics. ...

Multi-institutional distributed data networks for real-world evidence about medical devices: building unique device identifiers into longitudinal data (BUILD)

JAMIA Open

... The distinction between implants being placed in a patient versus being wasted or lost would also have to be incorporated into information systems as well. Building those interfaces should not be a major challenge, however, and in fact it could improve patient safety and inventory management by providing a validation/verification step (Tcheng et al. 2021;Reed et al. 2017). ...

The Medical Device Unique Device Identifier as the Single Source of Truth in Healthcare Enterprises – Roadmap for Implementation of the Clinically Integrated Supply Chain

... (nhsrcindia; Gagliardi et al. 2018;pci.nic.in;Jang et al. 2017;Hughes 2008;Wilson et al. 2021). Five reports that post marketing surveillance plays a vital role in reporting of adverse events of medical devices (Jang et al. 2017;Wilson et al. 2021;Maisel 2004;Badnjević et al. 2022;Gupta et al. 2017) Also, it has been observed seven organization factors are reported which affect the reporting of adverse events of medical devices (Amoore and Ingram 2003;Vicente and Kern 2005;Saifuddin et al. 2022;Polisena et al. 2015;Hoda et al. 2020;Kalaiselvan et al. 2020;Blake 2013). ...

Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care

... La reflexión plantea un reto importante a la hora de poner en práctica un enfoque educativo basado en las competencias, ya que exige alcanzar un delicado equilibrio entre la introspección subjetiva y los resultados mensurables en los que hace hincapié la educación basada en las competencias (45) . No obstante, reconocer la importancia de ahondar en nuestras motivaciones y prejuicios es crucial para obtener un conocimiento más profundo de uno mismo. ...

ACGME Interventional Cardiology Milestones 2.0–an overview: Endorsed by the Accreditation Council for Graduate Medical Education
  • Citing Article
  • October 2021

Catheterization and Cardiovascular Interventions