Cargando…

Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators

OBJECTIVES: To examine the current state of unique device identifier (UDI) implementation, including barriers and facilitators, among eight health systems participating in a research network committed to real-world evidence (RWE) generation for medical devices. DESIGN: Mixed methods, including a str...

Descripción completa

Detalles Bibliográficos
Autores principales:	Dhruva, Sanket S., Ridgeway, Jennifer L, Ross, Joseph S., Drozda,, Joseph P., Wilson, Natalia A
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2023
Materias:	Original Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9872505/ https://www.ncbi.nlm.nih.gov/pubmed/36704544 http://dx.doi.org/10.1136/bmjsit-2022-000167

Ejemplares similares

Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers
por: Wilson, Natalia A, et al.
Publicado: (2022)

Advancing Patient Safety Surrounding Medical Devices: A Health System Roadmap to Implement Unique Device Identification at the Point of Care
por: Wilson, Natalia A, et al.
Publicado: (2021)

Integrating real-world data to assess cardiac ablation device outcomes in a multicenter study using the OMOP common data model for regulatory decisions: implementation and evaluation
por: Yu, Yue, et al.
Publicado: (2023)

Multi-institutional distributed data networks for real-world evidence about medical devices: building unique device identifiers into longitudinal data (BUILD)
por: Drozda, Joseph P, et al.
Publicado: (2022)

Feasibility of Using Real-World Data to Replicate Clinical Trial Evidence
por: Bartlett, Victoria L., et al.
Publicado: (2019)

Feasibility of capturing real-world data from health information technology systems at multiple centers to assess cardiac ablation device outcomes: A fit-for-purpose informatics analysis report
por: Jiang, Guoqian, et al.
Publicado: (2021)

Use of Mechanical Cardiopulmonary Resuscitation Devices for Out-of-Hospital Cardiac Arrest, 2010-2016
por: Kahn, Peter A., et al.
Publicado: (2019)

Characterization of US Food and Drug Administration Class I Recalls from 2018 to 2022 for Moderate- and High-Risk Medical Devices: A Cross-Sectional Study
por: Mooghali, Maryam, et al.
Publicado: (2023)

Advancing the Real-World Evidence for Medical Devices through Coordinated Registry Networks
por: Sedrakyan, Art, et al.
Publicado: (2022)

Medical device risk (re)classification: lessons from the FDA’s 515 Program Initiative
por: Mooghali, Maryam, et al.
Publicado: (2023)

Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018
por: Rathi, Vinay K, et al.
Publicado: (2023)

Feasibility of using real-world data in the evaluation of cardiac ablation catheters: a test-case of the National Evaluation System for Health Technology Coordinating Center
por: Dhruva, Sanket S, et al.
Publicado: (2021)

Feasibility of Using Real-world Data to Emulate Postapproval Confirmatory Clinical Trials of Therapeutic Agents Granted US Food and Drug Administration Accelerated Approval
por: Wallach, Joshua D., et al.
Publicado: (2021)

How real-world evidence can really deliver: a case study of data source development and use
por: Drozda, Joseph, et al.
Publicado: (2020)

Medical Device Regulation: Time to Improve Performance
por: Dhruva, Sanket S., et al.
Publicado: (2012)

Evidence supporting FDA approval and CMS national coverage determinations for novel medical products, 2005 through 2016: A cross-sectional study
por: Roginiel, Aliya C., et al.
Publicado: (2018)

Coverage of Novel Therapeutic Agents by Medicare Prescription Drug Plans Following FDA Approval
por: Shaw, Daniel L., et al.
Publicado: (2018)

Physical activity, patient-reported symptoms, and clinical events: Insights into postprocedural recovery from personal digital devices
por: Bartlett, Victoria L., et al.
Publicado: (2021)

Emulating the GRADE trial using real world data: retrospective comparative effectiveness study
por: Deng, Yihong, et al.
Publicado: (2022)

Real-world Cardiovascular Outcomes Associated With Degarelix vs Leuprolide for Prostate Cancer Treatment
por: Wallach, Joshua D., et al.
Publicado: (2021)

Trends in Within-Class Changes in US Average Wholesale Prices for Brand-Name Medications for Common Conditions From 2015 to 2020
por: Liu, Patrick, et al.
Publicado: (2021)

Aggregating multiple real-world data sources using a patient-centered health-data-sharing platform
por: Dhruva, Sanket S., et al.
Publicado: (2020)

Real-World Implementation of Video Outpatient Consultations at Macro, Meso, and Micro Levels: Mixed-Method Study
por: Greenhalgh, Trisha, et al.
Publicado: (2018)

Postmarketing commitments for novel drugs and biologics approved by the US Food and Drug Administration: a cross-sectional analysis
por: Wallach, Joshua D., et al.
Publicado: (2019)

Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
por: Skydel, Joshua J., et al.
Publicado: (2019)

Real-World LEAP Implementation
por: Koplin, Jennifer J., et al.
Publicado: (2022)

Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice
por: Dhruva, Sanket S., et al.
Publicado: (2022)

Accurate estimation of cardiovascular risk in a non-diabetic adult: detecting and correcting the error in the reported Framingham Risk Score for the Systolic Blood Pressure Intervention Trial population
por: Warner, Frederick, et al.
Publicado: (2018)

Organic Dissemination and Real-World Implementation of Patient Decision Aids for Left Ventricular Assist Device
por: Thompson, Jocelyn S., et al.
Publicado: (2018)

GLASS(Y) Half-Full: Moving Towards Greater Pragmatism in Outcome Ascertainment for Clinical Trials
por: Dhruva, Sanket S.
Publicado: (2021)

The Medical Device Unique Device Identifier as the Single Source of Truth in Healthcare Enterprises – Roadmap for Implementation of the Clinically Integrated Supply Chain
por: Tcheng, James E, et al.
Publicado: (2021)

Stepping into the real world: a mixed-methods evaluation of the implementation of electronic patient reported outcomes in routine lung cancer care
por: Girgis, Afaf, et al.
Publicado: (2022)

4505 Implementation of Real-World Data and Real-World Evidence in Clinical Studies
por: Pham, Jessica, et al.
Publicado: (2020)

Challenges in Procalcitonin Implementation in the Real-World
por: Nguyen, Cynthia T, et al.
Publicado: (2018)

Trends in Spending and Claims for P2Y12 Inhibitors by Medicare and Medicaid From 2015 to 2020
por: Essa, Mohammed, et al.
Publicado: (2023)

Prostaglandin Coverage and Costs to Medicare and Medicare Beneficiaries, 2009-2017
por: Bartlett, Victoria L., et al.
Publicado: (2020)

Collaborative care in real-world settings: barriers and opportunities for sustainability
por: Sanchez, Katherine
Publicado: (2017)

In the Real-World, Kids Use Medications and Devices
por: Lasky, Tamar
Publicado: (2017)

Selective reporting in trials of high risk cardiovascular devices: cross sectional comparison between premarket approval summaries and published reports
por: Chang, Lee, et al.
Publicado: (2015)

Problem management : an implementation guide for the real world
por: Hall, Michael G
Publicado: (2014)

Cannot write session to /tmp/vufind_sessions/sess_vsvpn3vagq0pmqp3n7u3768ord