ArticleJournal of the American Medical Informatics Association : JAMIA2021
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.
Article in Journal of the American Medical Informatics Association : JAMIA, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed.
- 2024 HRS perspective on advancing workflows for CIED remote monitoring.Heart rhythm O2 · 2024Article
- Real-world data to support post-market safety and performance of embolization coils: evidence generation from a medical device manufacturer and data institute partnership.BMC medical informatics and decision making · 2024Article
- Limitations of NHIC claim code-based surveillance and the necessity of UDI implementation in Korea.Scientific reports · 2024Article
- Validation and clinical discovery demonstration of breast cancer data from a real-world data extraction platform.JAMIA open · 2024Article
- Predictive utility of the impedance drop on AF recurrence using digital intraprocedural data linked to electronic health record data.Heart rhythm O2 · 2024Article
- Using real-world data from health systems to evaluate the safety and effectiveness of a catheter to treat ischemic ventricular tachycardia.Journal of interventional cardiac electrophysiology : an international journal of arrhythmias and pacing · 2023Article
- Article
- Review of approvals and recalls of US specific medical devices in general and plastic surgery.Surgery in practice and science · 2023Article
- Exploring unique device identifier implementation and use for real-world evidence: a mixed-methods study with NESTcc health system network collaborators.BMJ surgery, interventions, & health technologies · 2023Article
- Safety and Effectiveness of a Catheter With Contact Force and 6-Hole Irrigation for Ablation of Persistent Atrial Fibrillation in Routine Clinical Practice.JAMA network open · 2022Article
- Synergies between centralized and federated approaches to data quality: a report from the national COVID cohort collaborative.Journal of the American Medical Informatics Association : JAMIA · 2022Article
- Advancing Patient Safety Surrounding Medical Devices: Barriers, Strategies, and Next Steps in Health System Implementation of Unique Device Identifiers.Medical devices (Auckland, N.Z.) · 2022Article
- 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.BMJ surgery, interventions, & health technologies · 2021Article
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
objectiveThe study sought to conduct an informatics analysis on the National Evaluation System for Health Technology Coordinating Center test case of cardiac ablation catheters and to demonstrate the role of informatics approaches in the feasibility assessment of capturing real-world data using unique device identifiers (UDIs) that are fit for purpose for label extensions for 2 cardiac ablation catheters from the electronic health records and other health information technology systems in a multicenter evaluation. MATERIALS AND
methodsWe focused on data capture and transformation and data quality maturity model specified in the National Evaluation System for Health Technology Coordinating Center data quality framework. The informatics analysis included 4 elements: the use of UDIs for identifying device exposure data, the use of standardized codes for defining computable phenotypes, the use of natural language processing for capturing unstructured data elements from clinical data systems, and the use of common data models for standardizing data collection and analyses.
resultsWe found that, with the UDI implementation at 3 health systems, the target device exposure data could be effectively identified, particularly for brand-specific devices. Computable phenotypes for study outcomes could be defined using codes; however, ablation registries, natural language processing tools, and chart reviews were required for validating data quality of the phenotypes. The common data model implementation status varied across sites. The maturity level of the key informatics technologies was highly aligned with the data quality maturity model.
conclusionsWe demonstrated that the informatics approaches can be feasibly used to capture safety and effectiveness outcomes in real-world data for use in medical device studies supporting label extensions.
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