Patient-Reported Outcome Measures
in PAD (PROM-PAD) Working Group

Comment from the Co-Chairs

Peripheral artery disease (PAD) affects hundreds of millions of people around the world, causing disability, functional decline, limb loss and death. Yet we understand relatively little about how the disease or the treatments we offer affect patients in their everyday lives. It has become critical that we develop standardized approaches to capture direct patient-reported outcome measures (PROMs) in PAD so that we can better measure clinical effectiveness and value in vascular care, and design treatments that are truly impactful. Incorporation of these PROMs into clinical trials, registries, and everyday practice provides a way forward to patient-centered care for the vascular patient.

Vascular Cures, the only non-profit foundation focused exclusively on vascular disease, has taken up this important mantle by creating the PROM-PAD Working Group. The recent kickoff meeting of this group in the nation’s capital brought together a multi-disciplinary group of clinical experts, scientists, governmental and industry stakeholders — as well as several patients with PAD who provided direct and powerful input. We are excited to catalyze this important work. In the coming months the PROM-PAD working group will develop one or more consensus documents, as well as suggest key research initiatives, to advance this field. Our goal is not simply to provide recommendations to the PAD community, but to catalyze implementation of PROMs in a feasible, meaningful, and scientifically sound fashion to improve the lives of patients with PAD.

Manesh R. Patel, MD
Chief, Division of Cardiology and the Division of Clinical Pharmacology
Duke University Health System
Michael S. Conte, MD
Chief, Division of Vascular and
Endovascular Surgery
University of California San Francisco
Chief Medical Officer, Vascular Cures
Working Group Background

The program is an outgrowth of our 2018 Vascular Research Summit, at which 60+ leaders from over 30 organizations prioritized unmet needs to improve vascular outcomes. These included the need to define consistent patient-reported outcome measures in PAD clinical research and care. Patient-reported outcomes are health information obtained directly from patients themselves instead of from doctors or medical tests. 

The working group will be a transparent, non-competitive approach to developing consensus views and actionable strategies for advancing the use of patient-report outcome measures across all sectors.

Working Group Participants

 

Organizers:

Michael Conte, MD – Vascular Cures/UCSF
Manesh Patel, MD – Duke University
Jennifer Rymer, MD, MBA – Duke University

 

Patients:

Gertrude C. – Patient
Steve H. – Patient
Pam P. – Patient
Samuel P. – Patient

 

Medical Research & Care:

Victor Aboyans, MD, PhD – Dupuytrens University Hospital, Limoges, France
David G. Armstrong, PhD, DPM – Keck School of Medicine
Niteesh Kumar Choudhry, MD, PhD – Harvard
Matthew A. Corriere, MD, MS – University of Michigan
Patrick Geraghty, MD, FACS – Washington University
Phillip Goodney, MD, MS – Dartmouth
Naomi M. Hamburg, MD, MS – Boston University
William Hiatt, MD – University of Colorado
Scott Kinlay, PhD, MBBS – Harvard
Robert Lookstein, MD – Mount Sinai
Mary McDermott, MD – Northwestern
Matthew T. Menard, MD – Harvard
Mehdi Shishehbor, DO, PhD, MPH – University Hospitals
Kim G. Smolderen, PhD – University of Missouri Kansas City/Saint Luke’s Mid America Heart Institute
Bjoern Suckow, MD, MS – Dartmouth
Samir Kaushik Shah, M.D. – University of Florida
Diane Treat-Jacobson, PhD, RN – University of Minnesota

 

FDA/NIH:

Donna Buckley, MD – FDA, CDRH
Joseph Chin, MD – CMS
Ebony Dashiell-Aje, PhD – FDA, CDER
Zorina Galis, PhD – NHLBI
Misti Malone, PhD – FDA, CDRH
Norman Stockbridge, MD, PhD – FDA, CDER

 

Industry:

Jason Belzer – Abbott Vascular
James Hasegawa – Abbott Vascular
Julie Prillinger, PhD – Abbott Vascular
Jason Exter – Amgen
Stefanie Kespohl, PhD – Bayer
Lars Schwichtenberg, PhD – Bayer
Christine Prinzivalli – Boston Scientific
Cole Scattarelli – Boston Scientific
Aaron Lottes, PhD – Cook Medical
Pete Polverini – Cook Medical
Merrill Birdno, PhD – Gore
Ann Ensley, PhD – Gore
Daniel Dadourian, MD – Janssen
Peter Wildgoose, PhD – Janssen
Arslan Malik, MBBS, MBA – Medtronic
Anna Szafranski – Medtronic

Thank you to our generous sponsors: