The majority of patients with peripheral artery disease (PAD) would like to be involved in the decision making process for their PAD treatments.¹ As patients with PAD often seek care because of lower-extremity symptoms, a variety of options are available to manage their symptoms. While all patients benefit from cardiovascular risk management, management of lower extremity symptoms depend on the overall goals of the patient.² Guideline-directed medical therapy, exercise therapy, and endovascular treatment are all options to manage PAD symptoms. Guidelines recommend exercise and medications as a first line of treatment, but quality of life and patient preferences are recognized as key factors to weigh in the decision-making process as well.²

As an example, an active 50-year-old with lower extremity claudication pain may slow the patient down and being back up on their feet to spend time with the grandkids may be a key consideration that would influence an aggressive invasive approach. On the other hand, a 79-year-old woman with atrial fibrillation, scleroderma, and high grade asymptomatic carotid artery stenosis who presents with mild symptoms of claudication may choose to manage her symptoms through exercise as the safer option. Understanding the procedural risks associated with ever evolving endovascular as well as surgical options, timeline of recovery for the different options and durability of therapies in a fast-paced clinical environment may be challenging for patients as they try to grapple with the impact of a diagnosis of a chronic condition.

Decision aids are precisely designed to navigate treatment decisions that may be ambiguous to patients. They provide facts about the condition, therapeutic options, and potential outcomes. In addition, they support patients in evaluating outcomes that matter most to them, and walk them through this process such that communication can be optimized and a choice can be made that matches patients' informed values.³

For PAD, few validated options for shared decision-making are available. Recently, we developed the showme-pad.org, a tool for patients with symptomatic PAD (excluding critical limb ischemia) along with patients and clinicians.⁴ Patients have different needs for information and want to be able to choose from different formats to get their information. For some, a brochure may be the right format; others prefer listening to patient stories or want a structured process the care team can walk them through. Show Me PAD was able to provide this variety of materials, and alpha and beta testing demonstrated that it was well received.⁴

Additional steps need to be taken before shared decision-making for PAD can become part of routine care. Developing and testing tools and keeping them updated with the latest evidence is a resource-intense process that requires a diverse representation of patient and provider stakeholders to review  literature through a stepwise and iterative development process,⁵ followed by several stages of validation. Following this extended validation process, efficacy testing comes next. While efficacy testing using a pre-and post-design is underway to measure its effect on decisional quality (increase in treatment satisfaction, reduction of decisional conflict and decision regret), no randomized controlled trial evidence is yet available to measure the benefit of decision aids in PAD. Much of this work has already been completed for other conditions, which can serve as roadmaps as to what can be accomplished for patients suffering from PAD. The Centers for Medicare & Medicaid Services are now requiring shared decision-making as a condition of coverage for lung cancer screening with low-dose computed tomography, for left atrial appendage closure for stroke prophylaxis in atrial fibrillation, and for primary prevention implantable cardioverter-defibrillators for patients with systolic heart failure.^6,7

Shared decision-making tools can have an impact on many outcomes of interest that have the potential to improve the quality of PAD care, and future randomized trials involving shared decision-making in PAD need to evaluate benefit in the following domains. Decision aids have the potential to increase knowledge and to enable patients to become more actively involved in the decision-making process.³ Implementing shared decision approaches may also reduce costs; one example: providing decision-aids to patients undergoing hip- and knee replacements assisted patients in choosing up to 38% fewer surgical procedures and realize significant savings over time.⁸ Costs for PAD treatments are ever increasing,⁹ and as we think about designing PAD care in ways that would fit a value-based care model, shared decision-making could be an important instrument to help deliver higher value care. Lastly, we also know that PAD affects many patients from underserved settings, and shared decision-making could aid in addressing some access to care barriers felt by underserved populations. Initial evidence demonstrates that the benefits (better knowledge, less decisional conflict, more engaged) of shared decision-making interventions are specifically felt among underserved populations who have low literacy, as compared with those who have higher literacy, education, and socio-economic status.¹⁰

Besides supporting underserved populations in their ability to obtain high quality PAD care and decision-making, other needs for the space of shared decision making in PAD include further evidence building to develop robust outcomes prediction models associated with evolving therapeutic options using clinical outcomes that matter to the patient. As PAD can have different presentation forms, different outcomes models are needed for different treatment choices. For example, patients with critical limb ischemia (CLI) face different choices as it relates to their treatment (e.g., long-term wound management vs. amputation) as opposed to patients with claudication, and little is still known about how different treatment trajectories result in different health status outcomes for patients with CLI. Lastly, a culture shift towards shared decision-making needs to take place and be shared by the multidisciplinary PAD team and their health system, which requires building relational competencies and risk communication competencies, which is still an area of significant growth for current PAD care.^11,12

References

1. Provance JB, Spertus JA, Decker C, Jones PG, Smolderen KG. Assessing patient preferences for shared decision-making in peripheral artery disease. Circ Cardiovasc Qual Outcomes 2019;12:e005730.
2. Gerhard-Herman MD, Gornik HL, Barrett C, et al. 2016 AHA/ACC guideline on the management of patients with lower extremity peripheral artery disease: a report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol 2017;69:1465-1508.
3. Stacey D, Légaré F, Col NE, et al. Decision aids for people facing health treatment or screening decisions. Cochrane Database Syst Rev 2014:Jan 28:[Epub ahead of print].
4. Smolderen KG, Pacheco C, Provance J, et al. Treatment decisions for patients with peripheral artery disease and symptoms of claudication: development process and alpha testing of the SHOW-ME PAD decision aid. Vasc Med 2021:26:273-80.
5. Elwyn G, O'Connor AM, Bennett C, et al. Assessing the quality of decision support technologies using the International Patient Decision Aid Standards instrument (IPDASi). PloS One 2009;4:e4705.
6. Knoepke CE, Allen LA, Kramer DB, Matlock DD. Medicare andates for shared decision-making in cardiovascular device placement. Circ Cardiovasc Qual Outcomes 2019;12:e004899.
7. Goodwin JS, Nishi S, Zhou J, Kuo YF. Use of the shared decision-making visit for lung cancer screening among Medicare enrollees. JAMA Intern Med 2019;179:716-18.
8. Oshima Lee E, Emanuel EJ. Shared decision-making to improve care and reduce costs. N Engl J Med 2013;368:6-8.
9. Kohn CG, Alberts MJ, Peacock WF, Bunz TJ, Coleman CI. Cost and inpatient burden of peripheral artery disease: findings from the National Inpatient Sample. Atherosclerosis 2019;286:142-6.
10. Durand MA, Carpenter L, Dolan H, et al. Do interventions designed to support shared decisionmaking reduce health inequalities? A systematic review and meta-analysis. PloS One 2014;9:e94670.
11. Légaré F, Moumjid-Ferdjaoui N, Drolet R, et al. Core competencies for shared decision-making training programs: insights from an international, interdisciplinary working group. J Contin Educ Health Prof 2013;33:267-73.
12. de Mik SML, Stubenrouch FE, Balm R, Ubbink DT. Systematic review of shared decision-making in surgery. Br J Surg 2018;105:1721-30.

Clinical Topics: Arrhythmias and Clinical EP, Cardiovascular Care Team, Heart Failure and Cardiomyopathies, Noninvasive Imaging, Prevention, Atherosclerotic Disease (CAD/PAD), Implantable Devices, SCD/Ventricular Arrhythmias, Atrial Fibrillation/Supraventricular Arrhythmias, Acute Heart Failure, Chronic Heart Failure, Exercise, Vascular Medicine

Keywords: Middle Aged, Quality of Life, Patient Preference, Peripheral Arterial Disease, Early Detection of Cancer, Atrial Fibrillation, Defibrillators, Implantable, Vulnerable Populations, Heart Failure, Systolic, Carotid Stenosis, Atrial Appendage, Cardiovascular Diseases, Decision Making, Shared, Economic Status, Medicaid, Personal Satisfaction, Lung Neoplasms, Medicare, Risk Factors, Exercise Therapy, Pain, Decision Making, Primary Prevention, Decision Support Techniques, Heart Disease Risk Factors, Health Services Accessibility, Ischemia, Tomography, Stroke

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