Registry Assessment of Peripheral Interventional Devices (RAPID) ― Registry Assessment of Peripheral Interventional Devices Core Data Elements

Journal

J-STAGE

Authors W. Schuyler Jones, Mitchell W. Krucoff, Pablo Morales, Rebecca W. Wilgus, Anne H. Heath, Mary F. Williams, James E. Tcheng, J. Danica Marinac-Dabic, Misti L. Malone, Terrie L. Reed, Rie Fukaya, Robert Lookstein, Nobuhiro Handa, Herbert D. Aronow, Daniel J. Bertges, Michael R. Jaff, Thomas T. Tsai, Joshua A. Smale, Margo J. Zaugg, Robert J. Thatcher, Jack L. Cronenwett, Durham NC, Silver Spring Md, Tokyo Japan, New York NY, Providence RI, Burlington Vt, Newton Mass, Denver Colo, Tempe Ariz, Santa Clara Calif, Minneapolis Minn, Lebanon NH

Year Published 2018
Link to publication

Abstract

Background

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.