The My PAD study for patient-reported outcomes for peripheral vascular intervention in the Vascular Quality Initiative.

Abstract

To conduct a multicenter pilot program, My Peripheral Arterial Disease (My PAD), for the collection of patient-reported outcomes (PROs) from patients undergoing peripheral vascular intervention (PVI) within the Vascular Quality Initiative. Ten centers within the Society for Vascular Surgery Vascular Quality Initiative PVI Registry collected health-related quality-of-life (HR-QoL) surveys using a modified version of the Vascu-QoL-6 (VQ-6) and the EuroQoL-5D-5L (EQ-5D-5L) at three time periods: preoperative, early follow-up (1-3 months), and late follow-up (9-15 months) from April 1, 2021 to June 30, 2024. A variety of workflows including automated emails to patients were used. Survey completion rates and HR-QoL score changes were analyzed using paired Wilcoxon tests. Among 5845 eligible PVI procedures, 440 (7.5%) had a completed preoperative PRO. Of the patients who filled out a preoperative surveys, 247 (56.1%) had an early survey, and 104 (23.6%) completed all three time points. Successful collection of surveys varied across centers (preoperative 0.2%-29%, early follow-up 27%-89% of preoperative, and late follow-up 5%-60% of preoperative). Mean EQ-5D-5L scores significantly improved from preoperative to early follow-up (-2.7, P < .01) and preoperative to late follow-up (-2.9, P < .01) in the subset of 104 patients. VQ-6 scores increased from preoperative to early follow-up (+5.4, P < .01) and preoperative to late follow-up (+4.9, P < .01). Meaningful improvements in VQ-6 scores were observed for patients with claudication (N = 104) and chronic limb-threatening ischemia (N = 143) at early follow-up. No overall drop-off was observed at late follow-up (mean EQ-5D-5L + 0.5, P = .12 and VQ-6 - 0.6, P = .22). The My PAD pilot study demonstrates that the collection of PROs in the form of HR-QoL surveys is possible but challenging. Successful collection of PROs requires substantial resources and hands-on effort by motivated and dedicated vascular practices. PRO collection provided clinically meaningful insight with an improvement in HR-QoL scores after endovascular revascularization. Future efforts should focus on supporting multimodal implementation, including data collection directly from patient, integrated data collection within electronic medical records, and aligning financial incentives in an effort to make patient-centered outcomes a routine part of PAD quality assessment.