RAPID - Phase III Patient Science Group
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)
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.