RAPID - Phase III Patient Science Group

Leadership Team

Dr. Danny Bertges, Society for Vascular Surgery, Vascular Quality Initiative (Chair)

Renee Mitchell, Boston Scientific (Co-chair)

Dr. Jessica Simons, Society for Vascular Surgery, Vascular Quality Initiative (Co-chair)

Dr. Shelby Reed, Duke Clinical Research Institute (Co-chair)

Dr. Michelle Tarver, U.S. Food and Drug Administration (Co-chair)

Dr. Dan Stephens, Boston Scientific (Project Leader)

Work Product

The Patient Science Work Group will:

1) Develop and present content for a “Patient Science 101” interactive webinar to the RAPID community with a timeline of one to three months. 

2) Develop recommendations for peripheral arterial disease (PAD) for patient reported outcomes and incorporate into coordinated registry/research networks that meet the needs for clinical and regulatory usage within a timeline of three to six months. 

3) Complete a retrospective review of prior and existing industry sponsored device trials that have included patient reported outcomes (PROs) to analyze responsiveness of instruments such as the VQ-6 with a timeline for this of six to eighteen months. 

4) Plan a prospective study of PRO data elements within a clinical registry with a timeline of one to two years. 

5) Execute a patient preference study to examine the tradeoff between the predicted longer durability versus the potential for late mortality after treatment with a device with a timeline of one to two years. 

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