Abstract 334: Listening to a Diversity of Patient Voices To Design a High-Quality Peripheral Arterial Disease Registry Focusing on Patient-Centered Outcomes
Authors: Smolderen Kim , Decker Carole , Garavalia Brian , Scott Kathryn M , Chhatriwalla Emily G , Nugent Karen , Daniel William C , Rivas-Gotz Carlos , Mena Carlos , Spatz Erica , Stilp Erik , Spertus John A 
Published: July 2021

Background:
While peripheral arterial disease (PAD) greatly impacts patients’ health status (symptoms, function and quality of life) and risk for cardiovascular events, no prospective studies have examined the impact of treatments in routine clinical practice on these outcomes. To create a future, multi-center PAD registry focused on health status outcomes over time, we prospectively engaged PAD patients in a qualitative study to explore the optimal study design.

Methods:
In the PORTRAIT Phase I study, a multidisciplinary team (nurse, anthropologist, psychologist) conducted 6 focus groups in 2 US sites (May-Dec 2012). Groups were organized by their demographic characteristics: females, males, elderly mixed females/males, African-American females, African-American males, and Hispanic mixed females/males involving 22 PAD patients. Sessions were recorded, transcribed and coded using descriptive content analysis until thematic saturation occurred. Input was solicited on the patients’ experience with PAD (diagnosis, treatment, life-style impact), preferred outcomes, topics to measure, and study organization.

Results:
Participants’ ages ranged from 51-86 and included 12 females, 8 African Americans, and 3 Hispanics. Patients had undergone percutaneous (n=7), surgical (n=2), both (n=3) or neither (n=10) types of revascularization. Three main themes emerged: 1)
PAD symptom unawareness
in both patients and doctors caused significant delays in receiving both a diagnosis and treatment (e.g. a 56yo female:
“He said you basically have no blood flow in either leg. If you would have waited another week, you would have lost both of your legs.”).
2) Patients reported
substantial impact of PAD
on daily functioning and prioritized symptom relief, improved walking and quality of life as key outcomes (e.g. a 52yo male said:
“And then the improvement in quality of life¼ There was just no question about whether to do it [surgery]¼”).
And 3)
Inadequate patient-physician communication and information deficiency
about treatment options and outcomes were frequently reported (e.g. an 85yo female said:
“No, there was never any idea of what I should do or why I shouldn’t do it. Just if you want some stents, we’ll put them in.”).
With regards to optimal study design, facilitators of study participation included encouragement by their doctor to participate, and phone follow-up, while barriers included the cost of transportation and time taken off by family member (e.g. an 82yo female stated:
“My daughter does not work on Fridays, but doctors don’t want to give appointments on Fridays.”).

Conclusion:
Insights from a diverse sampling of PAD patients can guide registry development by defining what outcomes PAD patients value most, how best to develop the screening and research design, and how to be maximally inclusive of a wide variety of PAD patients.