General and Disease-Specific Factors Associated with Health Related Quality of Life Among Patients With Peripheral Artery Disease to Inform Treatment Selection in the Era of Patient-Reported Outcomes

Abstract

<h3>Introduction and Objective</h3> Patient-reported outcomes (PRO) have been championed for assessment of peripheral artery disease (PAD) severity and treatment outcomes. Limited evidence exists regarding factors associated with PRO that may affect their sensitivity to change with PAD interventions. We performed a prospective, cross-sectional study to evaluate how patient-level factors are associated with a validated PAD-specific health related quality of life (QOL) instrument, the VascuQol-6. <h3>Methods</h3> Patients were recruited from a diagnostic vascular unit based on referral for ankle brachial index (ABI) testing. All participants were assessed for PAD symptoms using the San Diego Claudication Questionnaire and tested for neuropathy using the Michigan Neuropathy Screening Instrument (MNSI). PAD-specific QOL was assessed using the VascuQol-6. Clinical data was collected from the medical record and patient-self report. Factors associated with QOL were evaluated using ANOVA, confidence intervals, and linear models. <h3>Results</h3> 70 patients were recruited and participated. Mean age was 67.8±11.7 years (Figure 1Figure 1Plot of age versus VascuQOI-6 summary score (P=0.011).Figure 1); 41% of participants were women and 87.1% were white, and 29% were current smokers. Comorbid conditions included diabetes (23.2%) and peripheral neuropathy (44.3%). Mean ABI was 0.77±0.29 and mean TBI was 0.48±0.23. PAD symptoms were classified as claudication in 48.6%, CLTI in 31.4%, and asymptomatic in 20%. Among symptomatic patients, 21 had multi-level symptoms, 13 had calf symptoms only, 4 had buttock symptoms only, and 3 had thigh symptoms (Figure 2Figure 2Distribution of Vascuqol-6 summary scores by anatomic symptom distribution (P=0.025).Figure 2). Symptoms were bilateral in 55 patients (78.6%). Patients with multi-level disease had lower QOL scores (13.8±4.0; 90% CI 12.3-15.3) versus those with no symptoms (17.6±4.8; 90% CI 16.1-19.2), calf symptoms (17.8±3.1; 90% CI 16.2-19.3) (P=0.024). In multivariable models QOL was associated with minimum ABI (P=0.020), symptom anatomic level (P=0.002) and age (P=0.001); a trend was also observed for symptom category (P=0.121). No associations between QOL and smoking status, diabetes, neuropathy, or bilateral versus unilateral symptoms were observed. <h3>Conclusions</h3> PAD-specific QOL assessments are associated with factors related and unrelated to PAD. Higher QOL scores among older participants was unanticipated and may impart ceiling effects that limit potential for improvement through PAD interventions in this subgroup, while patients with multi-level symptoms may have greater potential gains from PAD treatment. Future work following this cohort will explore changes in QOL over time and associations with treatment interventions, adverse events, and patient-level factors.