RAPID Think Tank

Final Agenda

Event Recordings

Part 1 (2 hr 25 min)

Part 2 (1 hr 17 min)

Part 3 (2 hr 59 min)

Hot Topics:

  • 1st Public Release of the Phase I RAPID Core Data Set for PAD Device Evaluation
  • Aligning RAPID with National Evaluation System for Health Technology (NEST), Sentinel, HSPC, and other ongoing initiatives
  • International alignment leveraging RAPID core data elements
  • RAPID implementation and clinical trial opportunities for Peripheral Devices
7:30-8:00 AM Registration and Refreshments
8:00–8:30 AM Welcome & Introductions
Danica Marinac-Dabic, FDA Update on National Evaluation System for Health Technologies (NEST)
William Maisel, FDA 

MDepiNet, PASSION, & RAPID in the Context of NEST
Mitchell Krucoff, DCRI

8:30-9:10 AM
Overview of RAPID
Jack Cronenwett, Society for Vascular Surgery (SVS)


RAPID Phase I Work Product Overviews:

§  Use cases, Flow Diagrams
James Tcheng, DCRI

§  GUDID Working Group Summary
Terrie Reed, FDA

§  Core Minimum Data Set
Schuyler Jones, DCRI

9:10-10:15 AM RAPID towards NEST: Lessons Learned, Common Themes and Potential

Terrie Reed, FDA

§  Use of General Patient Descriptors from Sentinel in RAPID
Richard Platt, Harvard Pilgrim 

§  Addressing issues impacting Adoption of UDI
Joseph Drozda, Mercy Health System 

§  Integrating RAPID Common Data Elements and modeling with the goals of HSPC
Stan Huff, Intermountain Healthcare 

Discussion: Lead Discussant
Greg Pappas, FDA

10:15-10:30 AM Break
10:30-11:45 AM RAPID Phase II:  Implementation core data elements    

§ Implementing RAPID Core Data Elements–NCDR PVI registry view
Thomas Tsai, American College of Cardiology (ACC)/National Cardiovascular Data Registry (NCDR)

§ Implementing RAPID Core Data Elements–VQI PVI registry view
Carrie Bosela, SVS VQI

§  MedStreaming EHR
Ahmed Saad, MedStreaming

§  PAD Characterization within a health system
Schuyler Jones, DCRI 

§  Multidisciplinary PVI Structured Reporting Standards
James Tcheng, DCRI

Discussion, Lead Discussants:
Donna Buckley, FDA
Pablo Morales, FDA

11:45-Noon       Break and Pick-up lunch boxes
12:00-1:00 PM Perspectives on Interactions & Implementation (Working Lunch
Leader: Mitchell Krucoff, DCRI


§  Centers for Medicare and Medicaid Services
Daniel Canos, Centers for Medicare and Medicaid Services (CMS)

Joseph Drozda, Mercy Health System

§  Health Systems Platform Consortium
Stan Huff, Intermountain Healthcare

§  The Pew Charitable Trust 
Anqi Lu, The Pew Charitable Trust 

§  FDA
Misti Malone, FDA

§  Sentinel
Richard Platt, Harvard Pilgrim

§  Industry
Melanie Raska, Boston Scientific  

Discussion, Lead Discussants 
Greg Pappas, FDA
Julia Skapik, ONC

1:00-2:45 PM Multi-Stakeholder Collaborative Approach to RAPID Phase III: Thinking Forward! 

Summary of RAPID Proposals
Robert Thatcher, 4C Medical Technologies

Lessons learned from SAFE-PCI
Britt Barham, DCRI

Lessons learned from VQI Dissection Study
Jack Cronenwett, SVS


Industry Partners
Brian Fortier, Aorta Medical
Aaron Lottes, Cook Medical
Dedra Markovich, Cook Medical
Melanie Raska, Boston Scientific
Justin Recknor, WL Gore
Josh Smale, Bard Peripheral Vascular 

Federal Partners
Misti Malone, FDA
Danica Marinac-Dabic, FDA
Jyme Schafer, CMS
Karen Ulisney, FDA

2:45-3:00 PM Break
3:00–3:45 PM International Opportunities and Methodological Considerations

IMDRF opportunities: Update on Registry Essential Principles (Slides coming soon)
Danica Marinac-Dabic, FDA

‘How will we do this?’ or ‘Now What?’ – Methodological Considerations moving forward
Sharon-Lise Normand, Harvard Medical School

Discussion, Lead Discussant
Art Sedrakyan, Weill Cornell Medical College

 3:45-4:00 PM NEST & Next steps
Pablo Morales, FDA
Jack Cronenwett, SVS
Robert Thatcher, 4C Medical Technologies
Danica Marinac-Dabic, FDA






MDEpiNet RAPID project seeks to improve quality, efficiency of peripheral interventional device evaluation

See also Endovascular Today

For immediate release August 24, 2016

The RAPID group included members from academia, industry, and the U.S. Food and Drug Administration.

RAPID’s Phase I results will be shared Sept. 14 at a meeting at FDA Headquarters in White Oak, Maryland.
A novel initiative launched by the Medical Device Epidemiology Network Public Private Partnership (MDEpiNet PPP) may provide much-needed clarity about how patients with peripheral artery disease (PAD) are best treated.

MDEpiNet PPP was formed in 2013 to find new approaches to health information infrastructure and analytic methodologies that could promote better clinical and regulatory science. The Duke Clinical Research Institute (DCRI) serves as the coordinating center for MDEPiNet PPP, which includes representatives from academia, patient groups, payers, industry, government, and professional societies. The DCRI’s Mitchell Krucoff, MD, serves as principal investigator of the Coordinating Center.

Mitchell Krucoff“The primary focus of MDEpiNet is to facilitate dialogue across stakeholders in disease-specific and device-specific working groups,” Krucoff said. “These groups facilitate identification of unmet needs and priorities for particular patient groups and devices, together with novel, pragmatic, approaches to developing solutions.”

One of MDEpiNet’s most active working groups is the Registry Assessment of Peripheral Interventional Devices (RAPID), which is focused on devices used to treat PAD. Patients with PAD, a disease in which atherosclerotic plaque builds up in the arteries supplying the legs, initially experience pain with walking, but more severe disease can lead to limb loss. The condition can be treated with a number of different methods, including combinations of medical therapy, invasive catheter-based procedures, and surgical bypass grafting. There are many kinds of interventional devices used, such as balloons, stents and atherectomy systems (to remove plaque), not all of which are approved by the U.S. Food and Drug Administration (FDA) for PAD treatment.

Without shared and uniformly defined data elements, it is difficult for researchers to compare the safety or effectiveness of one device to another.
Because the devices are produced by a variety of independent manufacturers, there are virtually no shared data that link patients to the devices with which they are treated.Similarly, there is no way to link specific patient outcomes to the devices. Without shared and uniformly defined data elements, it is difficult for researchers to compare the safety or effectiveness of one device to another.

“There is a real lack of knowledge,” said the DCRI’s James Tcheng, MD, chair of RAPID’s Informatics Working Group. “There is no uniform clinical description of the myriad ways in which patients can manifest PAD. There is no common lexicon among device manufacturers. And the fact that PAD treatment often involves three different kinds of physicians—interventional cardiologists, interventional radiologists, and vascular surgeons—makes things even more complicated.”

With co-chairs from academia, industry, and the FDA, the RAPID working group was tasked in Phase I of the project to develop a minimum core data set related to evaluation of the devices used to treat PAD patients. In Phase II of the RAPID program, the core data set will be implemented in several of the nation’s largest electronic health record and professional society registries in PAD. In Phase III this structured data content and access will be utilized in a prospective clinical trial.

 “This has been a very inclusive process,” said Robert Thatcher, co-chair of the RAPID project. “All of us from industry who focus on PAD solutions have been invited to participate in the design and development of RAPID. Most are involved and those who are not at this point are still invited to join. Our goal from the beginning is to advance the science behind the treatment of PAD while making sure all voices have been heard. By doing this we end up in the best possible place to effectively treat PAD over time.”

Identifying and defining a minimum set of core data elements to be publicly shared involved a blend of clinical and informatics expertise. Leading the effort to define these data elements was RAPID’s Clinical Work Group, chaired by the DCRI’s W. Schuyler Jones, MD. Working from a list of more than 4,000 existing data elements complied from pivotal device trials and national registries case report forms, the Working Group distilled and vetted a final list of around 100 unique PAD device data elements.

With the data elements identified and defined, the Informatics Work Group added the parameters and attributes needed by computer systems to make them interoperable and interchangeable between information technologies such as electronic health records (EHRs) and clinical data registries. This work will also facilitate the long-term follow-up of patients treated with these devices and lead to improvements in treatments of PAD across the lifecycle of interventional devices.

A third group, the Unique Device Identifier (UDI) group chaired by Terrie Reed, the senior advisor for UDI Adoption in the FDA’s Center for Devices and Radiological Health (CDRH).  This group develops methods to extract information from the FDA’s Global Unique Device Identification Database (GUDID) so that registries, EHRs, and others can leverage the FDA’s reference source of device information.

“The RAPID project has helped all participants to better see the value of working together to integrate UDI data from GUDID into device registries,” Reed said. “It is very rewarding to see the result of effective teamwork.”

“RAPID is a unique example of non-competitive collaboration by multiple medical specialties and device manufacturers that is critical for our patients,” Jack Cronenwett, MD, of the Society for Vascular Surgery/Vascular Quality Initiative. “It will lead to much more efficient vascular device evaluation using multiple sources of real world data, consistent with the FDA vision.”

CDRH Director Jeff Shuren, MD, JD, added, “This is an important step toward establishing the National Evaluation System for Health Technology.”

RAPID Working Group Meeting

Meeting Recordings


Meeting Objectives

  • Share RAPID overview with new stakeholders
  • Finalize RAPID Phase I
    • Face-to-face meetings of clinical, informatics and GUDID work groups to finalize Phase I work of prior conference calls
    • Work group reports and group discussion of any lingering issues
    • Identify strategy for reporting deliverables and finishing Phase I
  • Develop pathway to execute RAPID Phase II
    • Learning from others
    • Potential benefit for payers
    • Workable deadline and milestones
  • Discuss potential mechanisms and/or clinical studies where RAPID Phase III may be implemented
    • Manufacturers interests
    • International collaborations
    • US regulations and potential execution



07:30-8:00 AM           Registration and Refreshments

08:00-8:50 AM           Welcome

RAPID:  Within the context of a National Medical Device Surveillance System

Mitch Krucoff, Duke University

RAPID: Current state, and Plan for the day

Pablo Morales, FDA

Jack Cronenwett, Dartmouth-Hitchcock

Robert Thatcher, Cardiovascular Systems

09:00 -11:00 AM        Working Group break-outs: Finalize RAPID Phase I deliverables

 Clinical Work Group                                                                                                                      

Schuyler Jones, Duke University

  • Review work group, timeline, work performed, and key contributions
  • Finalize Phase I list of 100 data elements
    • Complete remaining data element and permissible value definitions
    • Complete remaining mapping of RAPID data elements to registries/trials’ CRFs
  • Plan & establish timeline for reporting deliverables
  • Summarize lessons learned and key points for report out to large group
  • Roadmap / assignments of work required to reach goals of Phase II and III

Informatics Work Group

James Tcheng, Duke University

  • Review working group goals, timeline, and key contributions
  • Finalize the minimum meta-data for the RAPID common clinical terminology set
  • High level review the work product of the clinical WG (informatics conformance perspective)
  • Plan the formulation / composition of the work product that will be most useful to (non-informatics) stakeholders
  • Plan the work (including resourcing) to accomplish an informatics instantiation of the RAPID common clinical term set
  • Discuss the “supplemental” UDI content gap from a principles / framework perspective (with the GUDID WG)
  • Plan & establish timeline for reporting deliverables

GUDID Work Group

Terrie Reed, FDA

  • Review working group goals, timeline, and key contributions
  • Review GUDID Summary and work on generalizing learnings from peripheral vascular registry experience to other device registries
  • Plan & establish timeline for reporting deliverables
  • Roadmap / assignments of work required to reach goals of Phase II and III

11:00 -11:15 AM        Break & Box lunch set-up


11:15-12:45 PM          Integration of Work Groups

Moderator: Jack Cronenwett, Dartmouth-Hitchcock

Working lunch, reports from each work group & discussion of topics that need joint review as we move into Phase II planning

Break-out Session Reports

  • Clinical WG             Schuyler Jones, Duke University
  • Informatics WG     James Tcheng, Duke University
  • GUDID Work Group            Terrie Reed, FDA


Barry Daniels,GMDN – Use of GMDN or other device categories

Julia Skapik, ONC – Integration with national data standards

12:45-1:00 PM            Break


1:00-2:30PM               RAPID Phase II, Core Data Set Extraction
Pablo Morales, FDA

Operationalizing data extraction from multiple sources using the core PVI dataset

Joe Drozda, Mercy Health System

  • Partnering with payers for data extraction /BMC2 experience

Hitinder Gurm, University of Michigan

Sophia Autrey, Center for Medicare and Medicaid Services

Bret Shillingstad, Epic

  • Open discussion

2:30 – 2:45 PM           Break

2:45-3:45 PM              RAPID Phase III

Moderators: Robert Thatcher, Cardiovascular Systems, Jack Cronenwett, Dartmouth-Hitchcock

Utilizing the RAPID core data set for research, quality improvement and safety surveillance

Perspectives from the medical device industry

Perspectives from international partners

Sara Takahashi, Pharmaceuticals and Medical Devices Agency (PMDA), Japan

3:45-4:00 PM              MDEpiNet Perspective, Next Steps

Danica Marinac-Dabic, FDA

Pablo Morales, FDA

Jack Cronenwett, Dartmouth-Hitchcock

Robert Thatcher, Cardiovascular Systems