Engaging patients and their caregivers in research to improve evidence-based, patient-centered and equitable care for chronic limb-threatening ischemia and advanced peripheral artery disease

Abstract

Chronic limb-threatening ischemia (CLTI) is the end stage of advanced peripheral artery disease (PAD), a condition that is estimated to affect more than 200 million individuals globally. CLTI poses significant risks to many patients, particularly those from underserved populations (e.g., racial/ethnic minorities, low-income individuals, and rural populations) who experience significant disparities in care and outcomes, including higher rates of amputation, reduced quality of life, and lower survival rates. In 2021, the non-profit Foundation to Advance Vascular Cures, with support from the Patient Centered Outcomes Research Institute (PCORI), created a working group made up of patients, caregivers, researchers, industry experts, and non-profit advocates to develop a roadmap to increase patient engagement in CLTI research. Following a literature review, the working group used surveys, interviews, collaborative discussions, and focus groups to gain information from multiple stakeholder groups over a two-year period. This project built capacity on education and learning with the key observations presented. Our observations include: (1) early engagement of patients and caregivers in the research process improves the study design and enables more meaningful research; (2) frequent interpersonal contact paired with targeted, minimally burdensome education in research and disease increases meaningful engagement of patients with CLTI and their caregivers; (3) building trust between patients, caregivers, and researchers is essential to the success of these initiatives; (4) qualitative research complements quantitative results because it can lead to a nuanced understanding of patient experiences, goals, and perspectives; and (5) patients and caregivers are more likely to engage when research-related information is easy to access and has low burden in terms of time and resources. These observations underscore the need for stakeholder input to research design as well as the plans of funders and investigators in this field. Stakeholders noted the particular need for outreach to traditionally underrepresented and underserved populations, with whom more research is needed to meaningfully address health disparities.

Keywords: Chronic limb-threatening ischemia (CLTI); Health disparities; Patient engagement; Peripheral artery disease (PAD); Stakeholder collaboration.

Figure 1.0:

CLTI Working Group Research Schematic

Figure 2.0:

CLTI Working Group Methods

Figure 3.0:

Key Research Engagement Obstacles Identified by Patients and Caregivers 1. Absence of personal connection: without meaningful participation in the study design and/or execution, patients and caregivers expressed an unwillingness to commit effort and time to research engagement. 2. Mistrust: trust in the research team, sponsor, and in the ethics, inclusivity and equity attributes of the study appeared correlated with interest in research engagement. 3. Lack of education: Across the board, the need for greater education about PAD/CLTI, disease patterns and treatment options was emphasized. 4. Logistical burden: flexibility and accommodation of time, economic, transportation and technical barriers are highly valued by patients and caregivers. 5. Absence of motivation: a repeated concern was lack of understanding about the purpose of the research study and how it holds meaning for patients, caregivers, or others like them.