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


Journal Article (Review)

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 and Results: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. 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.

Full Text

Duke Authors

Cited Authors

  • Jones, WS; Krucoff, MW; Morales, P; Wilgus, RW; Heath, AH; Williams, MF; Tcheng, JE; Marinac-Dabic, JD; Malone, ML; Reed, TL; Fukaya, R; Lookstein, R; Handa, N; Aronow, HD; Bertges, DJ; Jaff, MR; Tsai, TT; Smale, JA; Zaugg, MJ; Thatcher, RJ; Cronenwett, JL

Published Date

  • January 25, 2018

Published In

Volume / Issue

  • 82 / 2

Start / End Page

  • 316 - 322

PubMed ID

  • 29367497

Pubmed Central ID

  • 29367497

Electronic International Standard Serial Number (EISSN)

  • 1347-4820

Digital Object Identifier (DOI)

  • 10.1253/circj.CJ-17-1156


  • eng

Conference Location

  • Japan