Statement Highlights:

  • A new American Heart Association scientific statement provides an updated roadmap for incorporating patient-reported symptoms and quality of life assessments into routine care for people with peripheral artery disease (PAD or clogged leg arteries).
  • Patient-reported outcomes measures (PROMs) are systematic and validated ways of asking individuals with PAD to assess their symptoms and to share how their functioning (physical, social and emotional) and their quality of life are affected.
  • PROMs have been used as important endpoints for clinical trials evaluating PAD treatments.
  • According to the new statement, PROMs may also be used to evaluate the quality of programs providing ongoing care for people with PAD.

Embargoed until 4 a.m. CT / 5 a.m. ET Thursday, October 13, 2022

DALLAS, October 13, 2022 — For the approximately 8.5 million people in the U.S. living with peripheral artery disease (PAD – pronounced P-A-D), which is narrowed or clogged arteries in the legs, treatment decisions and criteria for success should be led by their symptoms and self-reported quality of life, according to a new American Heart Association scientific statement published today in the Association’s flagship, peer-reviewed journal Circulation. An American Heart Association scientific statement is an expert analysis of current research and may inform future treatment guidelines.

The statement, “Advancing peripheral artery disease quality of care and outcomes through patient-reported health status assessment,” highlights how managing PAD based on a person’s experience of symptoms can lead to more patient-centered care and outcomes, with a focus on high-value care, compared to relying on clinical measures like the speed of blood flow to the legs or artery diameter.

“The person living with peripheral artery disease is the authority on the impact it has on their daily life. Our treatment must be grounded in their lived experiences and go beyond the clinical measures of how well blood flows through the arteries,” said Vice Chair and lead author of the statement writing group Kim G. Smolderen, Ph.D., a clinical psychologist and an associate professor of medicine and psychiatry and co-director of the Vascular Medicine Outcomes Research (VAMOS) lab at Yale University in New Haven, Connecticut. “We have spent years developing and validating standardized instruments to capture people’s experiences in a reliable and sensitive way. We are now at a point where we can start integrating this information into real-world care, through pilot programs that can develop quality benchmarks for different phenotypes of patients with PAD and the types of treatments they undergo, as seen from their perspective.”

 Painful Legs and Other Patient Experiences

While the majority of people living with peripheral artery disease are older than age 40, PAD does occur in younger individuals as well. People with PAD have blockages in the arteries supplying blood to their legs and feet, often creating pain, cramping or weakness when they walk that makes it necessary to stop and rest temporarily until the pain subsides. Some people experience no symptoms; however, many patients might remain pain-free only because they limit their activities. Studies show that their health status and functioning is also impacted. People with severely limited blood flow to the legs (called critical limb ischemia) may experience pain even when resting, fail to heal when they sustain a wound or develop gangrene that may lead to amputation. PAD is also a risk factor for heart attack or stroke.

“All of these manifestations have a tremendous impact on people’s daily functioning and quality of life, with more impact as the severity of the disease increases. Outcomes are also affected by other health conditions common among people with PAD, such as Type 2 diabetes, coronary artery disease, kidney dysfunction or mental health conditions like depression or stress-related disorders,” said Smolderen.

Patient-led Treatment

When the health care team has an increased awareness and recognition of the burden of disease on quality of life, coordination of care for risk factors and patient concerns are at the forefront. The statement advocates for improving and individualizing the care of people with clogged leg arteries by gathering feedback from their experience throughout treatment.

Patient-reported outcomes measures (PROMs) are systematic and validated ways of asking patients directly to assess how their disease impacts their symptoms, their functioning (physical, social and emotional) and their quality of life. Feedback through PROMs can more reliably and objectively assess quality of care for people with PAD.

Key benefits of using PROMs include:

  • improving understanding of the patient’s lived experience with PAD;
  • improving patient’s self-management of symptoms and medical needs;
  • standardizing quality performance benchmarks for practices that care for people with PAD; and
  • providing relevant feedback to determine treatment changes or needs.

Engaging patients as the expert on their own experiences calls greater attention to quality-of-life concerns or cardiovascular risk factors, which may help clinicians think beyond a particular intervention. This perspective may lead to conversations that shift treatment or connect patients with other resources such as behavioral health services, wound care or smoking cessation. Patient-centered care may also enhance self-management and shared decision-making between patients and clinicians.

All of these benefits are possible as long as the patient-reported outcomes measures are assessed using tools that the patient understands regardless of literacy level, language barriers and cultural norms. It’s also important that PROMs are conducted by experts who have the qualifications and understanding to administer the tools, interpret the findings and connect patients with additional resources. The statement includes examples of PROMs to measure leg pain and functioning (including walking impairment), PAD-specific health status, general health status and depressive symptoms.

Performance Measures to Improve Quality of Care

PROMs may also become an integral part of assessing whether programs are providing quality care for people with PAD. Spurred by the Centers for Medicare and Medicaid Services and the National Quality Forum, PROMs are increasingly being integrated into definitions of what it means to deliver patient-centered ,high-quality clinical care, and PROMs scores may directly impact reimbursement. To evaluate programs, PROMs are translated into Patient-Reported Outcomes Performance Measures (PRO-PMs).

The use of PRO-PMs has the potential to:

  • provide measurable goals for programs to enhance their quality of care;
  • encourage the development of training and expertise for health systems to administer, interpret and ethically use PRO-PMs to improve patient care;
  • reduce disparities in care and promote health equity; and
  • aid in the creation of national standards for quality care.

“This roadmap highlights a paradigm shift that places the patient experience front and center, which is a departure from the status quo. It is provocative to now place the lived experience with the disease at the forefront, engaging people with PAD to provide information that holds health systems and practitioners accountable as to whether high-quality care was delivered, in addition to assessing the safe and effective delivery of current evidence-based treatments,” said Smolderen.

This scientific statement was prepared by the volunteer writing group on behalf of the American Heart Association’s Council on Peripheral Vascular Disease and the Council on Lifestyle and Cardiometabolic Health. The writing group includes a patient advocate and experts in clinical psychology, outcomes research, nursing, cardiology, vascular surgery and vascular medicine. It was important to ensure this statement embodied the interdisciplinary nature of PAD care and the dedication to innovating the vascular space, across vascular specialties. This meant including experts with experience both on the research end with PROs and the clinical experience with PAD, as well as with pioneers in the space of patient reported outcomes for cardiovascular populations and with direct input from patient advocates.

American Heart Association scientific statements promote greater awareness about cardiovascular diseases and stroke issues and help facilitate informed health care decisions. Scientific statements outline what is currently known about a topic and what areas need additional research. While scientific statements inform the development of guidelines, they do not make treatment recommendations. American Heart Association guidelines provide the Association’s official clinical practice recommendations.

Co-authors are Chair Carole Decker, Ph.D., R.N.; Olamide Alabi, M.D.; Tracie C. Collins, M.D., M.P.H., M.S.; Bernard P. Dennis, B.A.; Philip P. Goodney, M.D.; Carlos Mena-Hurtado, M.D.; and John A. Spertus, M.D., M.P.H. Authors’ disclosures are listed in the manuscript.

The Association receives funding primarily from individuals. Foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific Association programs and events. The Association has strict policies to prevent these relationships from influencing the science content. Revenues from pharmaceutical and biotech companies, device manufacturers and health insurance providers, and the Association’s overall financial information are available here.

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