The high price of equity in pulse oximetry: A cost evaluation and need for interim solutions.

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.

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.

The High Price of Equity in Pulse Oximetry: A cost evaluation and need for interim solutions.

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.

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.

Registry Assessment of Peripheral Interventional Devices (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 prespecify death as a long-term end point. In response to the directive, the LEAN-Case Report Form 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 peripheral arterial disease intervention in the drug-eluting device era, with the goal to have future mortality signals more accurately examined.

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

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).

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 bariatric surgery are being developed to bridge the treatment gap.

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

Background: The requirement for medical device manufacturers to label their devices with a unique device identifier (UDI) was formalized by the 2013 US Food and Drug Administration Unique Device Identification System Rule. However, parallel regulatory requirement for US health systems to use UDIs, particularly the electronic documentation of UDIs during patient care is lacking. Despite the lack of regulation, some health systems have implemented and are using UDIs.

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

Objectives: To support development of a robust postmarket device evaluation system using real-world data (RWD) from electronic health records (EHRs) and other sources, employing unique device identifiers (UDIs) to link to device information.

Methods: To create consistent device-related EHR RWD across 3 institutions, we established a distributed data network and created UDI-enriched research databases (UDIRs) employing a common data model comprised of 24 tables and 472 fields. To test the system, patients receiving coronary stents between 2010 and 2019 were loaded into each institution's UDIR to support distributed queries without sharing identifiable patient information.

Roadmap to a more useful and usable electronic health record.

Background: A decade after the Health Information Technology for Economic and Clinical Health (HITECH) Act, electronic health records (EHRs) largely remain poorly designed and contribute to clinician burnout.

Objective: The purpose of this study was to understand clinicians' wants, needs, and perceived barriers imposed by the EHR; implement best practices in user-centered design; and create a clinician-centered EHR framework validated via a functional EHR prototype.

Methods: Usability evaluations were performed using a simulated patient with a complex clinical scenario.

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

Documentation and tracking of supplies, equipment and medical devices is central to operational, financial, and clinical aspects of safe, efficient, and effective patient care. The labeling of medical devices with a unique device identifier (UDI) creates the opportunity to tightly integrate device information across health information systems by using the UDI as the index "source of truth". Across 3 hospitals of the Duke University Health System, we executed a comprehensive implementation of UDI-based device and supply information management in our cardiac catheterization and electrophysiology laboratories.

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

Background: The US Food and Drug Administration's Unique Device Identification System Rule of 2013 mandated manufacturers to assign unique device identifiers (UDIs) to their medical devices. Most high-risk (Class III), moderate-risk (Class II) and implantable devices now have UDIs. To achieve the necessary next step for a comprehensive UDI-enabled system for patient safety, UDIs must be electronically documented during patient care, a process not routinely done.

ACGME Interventional Cardiology Milestones 2.0-an overview: Endorsed by the Accreditation Council for Graduate Medical Education.

This document provides an overview of the rationale, development, interpretation, and practical suggestions for implementation of the new Accreditation Council for Graduate Medical Education (ACGME) Interventional Cardiology (IC) Milestones 2.0. Previously, IC programs used the general ACGME Milestones for internal medicine.

Multispecialty Enterprise Imaging Workgroup Consensus on Interactive Multimedia Reporting Current State and Road to the Future: HIMSS-SIIM Collaborative White Paper.

Diagnostic and evidential static image, video clip, and sound multimedia are captured during routine clinical care in cardiology, dermatology, ophthalmology, pathology, physiatry, radiation oncology, radiology, endoscopic procedural specialties, and other medical disciplines. Providers typically describe the multimedia findings in contemporaneous electronic health record clinical notes or associate a textual interpretative report. Visual communication aids commonly used to connect, synthesize, and supplement multimedia and descriptive text outside medicine remain technically challenging to integrate into patient care.

Registry Assessment of Peripheral Interventional Devices objective performance goals for superficial femoral and popliteal artery peripheral vascular interventions.

Background: The Superficial Femoral Artery-Popliteal EvidencE Development Study Group developed contemporary objective performance goals (OPGs) for peripheral vascular interventions (PVI) for superficial femoral artery (SFA)-popliteal artery disease using the Registry Assessment of Peripheral Interventional Devices.

Methods: The Society for Vascular Surgery Vascular Quality Initiative PVI registry from January 2010 to October 2016 was used to develop OPGs based on SFA-popliteal procedures (n = 21,377) for intermittent claudication and critical limb ischemia (CLI). OPGs included 1-year rates for target lesion revascularization (TLR), major amputation, and 1 and 4-year survival rates.

SUPPORT-1 (Subjects Undergoing PCI and Perioperative Reperfusion Treatment): A Prospective, Randomized Trial of CMX-2043 in Patients Undergoing Elective Percutaneous Coronary Intervention.

Objective: The natural molecule α-lipoic acid has been shown to be partially cytoprotective through antioxidant and antiapoptotic mechanisms. To obtain an initial assessment of the safety and potential efficacy of a synthetic derivative, CMX-2043, in preventing ischemic complications of percutaneous coronary intervention (PCI) we conducted the Subjects Undergoing PCI and Perioperative Reperfusion Treatment (SUPPORT-1) trial, the first patient experience with this agent.

Methods And Results: SUPPORT-1 was a phase 2a, 6-center, international, placebo-controlled, randomized, double-blind trial.

Determining the Suitability of Registries for Embedding Clinical Trials in the United States: A Project of the Clinical Trials Transformation Initiative.

Background: Patient registries are organized systems that use observational methods to collect uniform data on specified outcomes in a population defined by a particular disease, condition, or exposure. Data collected in registries often coincide with data that could support clinical trials. Integrating clinical trials within registries to create registry-embedded clinical trials offers opportunities to reduce duplicative data collection, identify and recruit patients more efficiently, decrease time to database lock, accelerate time to regulatory decision-making, and reduce clinical trial costs.

Telehealth transformation: COVID-19 and the rise of virtual care.

The novel coronavirus disease-19 (COVID-19) pandemic has altered our economy, society, and healthcare system. While this crisis has presented the U.S.

Achieving Data Liquidity: Lessons Learned from Analysis of 38 Clinical Registries (The Duke-Pew Data Interoperability Project.

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.

Current landscape of hybrid revascularization: A report from the NCDR CathPCI Registry.

Background: Hybrid revascularization, combining percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG), may be used differently across hospitals. How outcomes compare with multivessel PCI is unknown.

Methods: We studied hybrid revascularization use in patients in the National Cardiovascular Data Registry from 2009 to 2017 who underwent PCI for multivessel coronary artery disease (CAD) at 711 hospitals, excluding patients with prior CABG, acute ST-elevation myocardial infarction, emergency/salvage CABG, or PCI without stent placement.