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J Vasc Surg. 2018 Feb;67(2):637-644.e30. doi: 10.1016/j.jvs.2017.07.141.

Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements.

Author information

1
Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC. Electronic address: schuyler.jones@duke.edu.
2
Department of Medicine and Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC.
3
U.S. Food and Drug Administration, Silver Spring, Md.
4
Pharmaceuticals and Medical Devices Agency of Japan, Tokyo, Japan.
5
Mount Sinai Medical Center, New York, NY.
6
Lifespan Cardiovascular Institute, Alpert Medical School of Brown University, Providence, RI.
7
Division of Vascular Surgery, University of Vermont Medical Center, Burlington, Vt.
8
Newton-Wellesley Hospital and Harvard Medical School, Newton, Mass.
9
Institute for Healthcare Research, Kaiser Permanente Colorado, Denver, Colo.
10
Bard Peripheral Vascular, Inc, Tempe, Ariz.
11
Abbott Vascular, Inc, Santa Clara, Calif.
12
Chief Executive Officer, 4C Medical Technologies, Minneapolis, Minn.
13
Section of Vascular Surgery and The Dartmouth Institute, Dartmouth-Hitchcock Medical Center, Lebanon, NH.

Erratum in

Abstract

OBJECTIVE:

The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible.

METHODS:

Under the auspices of the U.S. Food and Drug Administration's Medical Device Epidemiology Network initiative-and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards-the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI.

RESULTS:

The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI.

CONCLUSIONS:

Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.

Comment in

PMID:
29389426
DOI:
10.1016/j.jvs.2017.07.141
[Indexed for MEDLINE]

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