Project Summary

Background: Chronic limb-threatening ischemia (CLTI), an advanced form of peripheral artery disease (PAD), is marked by decreased quality of life, high morbidity and mortality, and high costs to the healthcare system. CLTI patient engagement in research is lacking because the population is extremely heterogeneous, comorbid, and often limited by mobility, education, and finances. CLTI studies are limited and have struggled to answer questions that are meaningful to patients, to enroll patients, and to implement findings. There are also marked shortcomings in patient-reported outcome measures in CLTI research.

Proposed Solution to the Problem: There is a significant opportunity to create solutions that more closely align with CLTI patient needs by advancing patient-centered outcomes research/comparative clinical effectiveness research (PCOR/CER) that meaningfully engages patients as partners from research design to active trial participation and solution adoption. This working group will be the first of its kind to set patient-centered research priorities and enable the sustainable engagement of CLTI patients in PCOR/CER so that new findings and solutions can ultimately be more aligned with patient needs and preferences to improve patient outcomes.

Objectives: The multi-disciplinary, multi-stakeholder group of leaders and patients in vascular healthcare will sustainably enable knowledge generation around the comprehensive patient experience, patient preferences and priorities, barriers to patient engagement, and the current state of PCOR/CER in CLTI. Ultimately, activities will create the capacity to facilitate sustained, meaningful engagement of CLTI patients in PCOR/CER, and advance PCOR/CER in CLTI both within Vascular Cures and the vascular research and patient community. 

Activities: Key project activities will include: stakeholder focus groups, meetings, surveys, a landscape and gap analysis to evaluate and understand the comprehensive CLTI patient experience by disease stage; creation of a strategic roadmap and sustainability plan for implementation, development of consensus statements and/or manuscripts, toolkit development, trainings, and capacity-building activities for patient advisors and researchers; and dissemination of findings to end users summarizing applicable learnings that can inform and enable future patient engagement efforts needed to improve CLTI patient outcomes.

Projected Outcomes and Outputs: The project will ultimately generate both collective knowledge and tangible resources to facilitate patient engagement in PCOR/CER. Activities will enable an understanding of the comprehensive CLTI patient experience by stage (impact of pain, wound burden, and mobility on QOL), the current status of PCOR/CER and patient involvement in PCOR/CER, key barriers to patient engagement, and methods to overcome those barriers. Tangible outputs will include a prioritized list of patient-centric, high-impact research topics, a white paper summarizing learnings, and a publicly accessible toolkit of resources for stakeholders to facilitate meaningful patient engagement. This project will also create a core set of implementation partners and patient advocates who have undergone engagement training and are immediately ready to launch engagement activities. Vascular Cures will sustain and expand upon capacity built through this project program, subsequently leveraging learnings and capabilities to facilitate engagement of other vascular patient profiles in all types of research and national initiatives. 

Patient and Stakeholder Engagement Plan: Patient partners, representative of the broader CLTI patient population, will be meaningfully engaged as priority stakeholders in the project’s design, management, and execution. They will be identified through Vascular Cures’ Patients as Partners Program and its advocacy partner, The Way to My Heart.  Vascular Cures will leverage its existing network of stakeholders (from prior working groups and the advisory board) to identify those who are most likely to either meaningfully inform successful engagement strategies or facilitate CLTI patient engagement in PCOR/CER (end users).

Project Collaborators: The work will be led by a core group of advisors selected for their commitment to improving CLTI outcomes, prior collaborations, and experience in patient-centered outcomes research and patient engagement. Other collaborators (working group members) will include representatives from leading national organizations in patient care and research (vascular surgery, cardiology, podiatry, diabetology, vascular medicine), regulatory and policy, reimbursement, health systems, professional societies, patient advocacy, and patients themselves. 

Project Information

Megan Patterson, MS
Vascular Cures

Key Dates

24 months


Project Status
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: March 4, 2022