Working Groups

Bringing Together Decision-Makers for Collective Change

The Foundation to Advance Vascular Cures hosts our biennial Innovation & Research Summits to prioritize pressing needs in vascular research and care, and to identify collaborative solutions. The best ideas (and most-needed solutions) are turned into internal programs, special initiatives, and collaborative working groups.

CLTI Patient Engagement
(2021-2023)

Promoting and facilitating the inclusion of Chronic Limb-Threatening Ischemia (CLTI) patients in patient-centered clinical comparative effectiveness research.

This project was funded through a Patient-Centered Outcomes Research Institute (PCORI) Eugene Washington PCORI Engagement Award (EA #21136-VC). The views presented in this project are solely the responsibility of the Foundation to Advance Vascular Cures and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute® (PCORI®), its Board of Governors or Methodology Committee.

The project page for this Working Group can be accessed here: https://www.pcori.org/research-results/2021/working-group-enable-chronic-limb-threatening-ischemia-clti-patient-engagement-pcorcer

  • Chronic limb-threatening ischemia (CLTI) is an advanced form of peripheral artery disease (PAD) that can lead to amputation. People living with CLTI have a wealth of lived experiences to share that are distinct from the researchers who design and conduct trials to improve outcomes. Unfortunately, there is a lack of patient participation in research study design and execution. This means researchers struggle to find diverse and representative trial participants, and that study results do not always answer questions that are important to CLTI patients.

    To help address this problem, the Foundation to Advance Vascular Cures is convening a Working Group to promote and facilitate CLTI patient engagement in research. This initiative will build capacity to engage CLTI patients in research as advisors and participants, so that study results align with the needs of patients. It will also prioritize the kinds of research that are most important to patients.

    Ultimately, this work will create new knowledge and treatments that more closely align with CLTI patient needs and improve health outcomes.

    Working Group participants are dedicated to building a future in which academic researchers, industry partners, and people with CLTI can effectively collaborate to design and implement patient-centered trials with a high likelihood of success.  Members include representatives from patient care and research (vascular surgery, cardiology, podiatry, diabetology, vascular medicine), regulatory and policy, reimbursement, health systems, professional societies, patient advocacy, and patients themselves. This mix of stakeholders represents key institutions such as UCSF and Duke, as well as diverse parts of the country.

  • The Foundation to Advance Vascular Cures (VC) launched a Chronic Limb-Threatening Ischemia (CTLI) working group made up of patients, caregivers, researchers and providers in 2021. Its main goal was to build capacity of CLTI patients and caregivers to engage in patient-centered clinical Comparative Effectiveness Research (CER). CLTI is a severe form of peripheral artery disease (PAD). PAD is the chronic stage of atherosclerosis (plaque build-up) in the arteries of the legs. 2-5% of PAD patients develop CLTI, and it can lead to amputation of toes, feet, or legs if left untreated. Patient engagement in patient-centered CER has been shown to improve outcomes and alignment of that research with patient preferences. Yet, it has been almost non-existent in this disease space.

    The outputs for the project include a detailed landscape and gap analysis, a multi-stakeholder-informed list of top CLTI patient-centered CER priorities, a formal evaluation of engagement strategies for CLTI patients and toolkits to support engagement of patients and caregivers in patient-centered CER. Methods for collecting information and feedback included surveys, interviews, and working group meetings.

    The landscape analysis found a lack of patient-centered CER on CLTI patient engagement, quality of life, research, and interests/barriers, as well as a need to develop patient-centric tools to increase engagement. The multi-stakeholder list of research priorities focused on prevention and early diagnosis of CLTI, including factors such as diet, exercise, and family history; many of these lend themselves to high-impact patient-centered CER studies. The evaluation of engagement strategies found that no one strategy was sufficient to engage a diverse patient group, but generally speaking surveying had mixed results. While surveying is one of the quicker, lower-touch, cost-effective tools, it was most successful when paired with high levels of personal contact through phone or in-person. Meetings and interviews yielded richer, more nuanced data. Research engagement toolkits for patient partners and researchers were designed as mechanisms for building capacity that would support sustainability and growth of patient engagement in patient-centered CER.

    CLTI research has needed an increase of patient engagement for decades, as evidenced by the landscape/gap analysis. This project identified several key findings which will help to make future patient-centered CER in CLTI more accessible, engaging, beneficial, and effective for all stakeholders. For instance, key findings around recruitment and retention of patient partners will lead to higher and more meaningful engagement, improving the rigor of patient-centered CER and leading to more dynamic and useful outcomes that directly affect CLTI care. By taking steps early on in the research and development stages to include patient partners, all deliverables and outcomes are improved and the impact on stakeholders is increased.

    Note: This abstract was funded through a Patient-Centered Outcomes Research Institute (PCORI) Eugene Washington PCORI Engagement Award (EA #21136-VC). The statements presented in this abstract are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute® (PCORI®), its Board of Governors or Methodology Committee.

Patient-Reported Outcome Measures in PAD
(2018-2021)

Advancing patient-centered outcome measures in Peripheral Artery Disease.

  • 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.

    To help improve the use of PROMS in PAD, Vascular Cures created the PROM-PAD Working Group. The 2019 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 proud to have catalyzed this important work.

    In 2022 the PROM-PAD working group published two papers that will advance this field. The goal of the effort was 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.

    For a summary of the papers, click here.

  • A Systematic Review of Patient Reported Outcome Measures (PROMs) for Patients with Chronic Limb Threatening Ischemia  – Journal of Vascular Surgery, May 2022

    Patient-Reported Outcome Measures in Symptomatic, Non-Limb Threatening Peripheral Artery Disease: A State-of-the-Art Review – Circulation: Cardiovascular Interventions, January 2022

  • Organizers:

    · Michael Conte, MD – Vascular Cures/UCSF

    · Manesh Patel, MD – Duke University

    · Jennifer Rymer, MD, MBA – Duke University

    Patients:

    · Gertrude – Patient Advocate

    · Steve – Patient Advocate

    · Pamela – Patient Advocate/Caregiver

    · Samuel – Patient Advocate

    Medical Research & Care:

    · Victor Aboyans, MD, PhD – Dupuytren University Hospital, Limoges, France

    · David G. Armstrong, PhD, DPM – USC Keck School of Medicine

    · Matthew A. Corriere, MD, MS – University of Michigan

    · Patrick Geraghty, MD, FACS – Washington University

    · Phillip Goodney, MD, MS – Dartmouth College

    · Naomi M. Hamburg, MD, MS – Boston University

    · William Hiatt, MD – University of Colorado

    · Scott Kinlay, PhD, MBBS – Harvard University

    · Robert Lookstein, MD – Mount Sinai

    · Mary McDermott, MD – Northwestern University

    · Matthew T. Menard, MD – Harvard University

    · Kim G. Smolderen, PhD – Yale University

    · Bjoern Suckow, MD, MS – Dartmouth College

    · Samir Kaushik Shah, MD – 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