Table 2.

Integration of PROMs into PAD treatment effectiveness studies.

Study	Population screened	Treatment arms	Functional outcome tools	PROMs tools	Follow-up period	Changes
Murphy (2015)10 (CLEVER study)	111 patients with aortoiliac PAD, multicenter	Optimal medical care alone; both SET and medical care; or both revascularization and medical care	Treadmill-based walking, ABI	SF-12, WIQ, PAQ	18 months	Combination arms had greater improvements in disease-specific PROMs; SET cohort had greater improvements in PAQ scores compared to revascularization cohort
Gray (2015)28 (STROLL study)	250 subjects with de novo or restenotic lesions of superficial femoral artery, multicenter	One or more SMART® bare-metal stents	Rutherford/Becker classification, resting or exercise ABI, angiographic studies	PAQ, WIQ, EQ-5D, SF-12	3 years	PAQ summary scores showed significant health status gains at 1 month, with more than 85% of the gain maintained during a 3-year period
Mustapha (2019)43 (LIBERTY 360° study)	1200 patients with claudication and CLI, multicenter	Treatment with an FDA-approved peripheral endovascular device intervention	Rutherford classification, angiography imaging, duplex ultrasonography	VascuQoL, EQ-5D	12 months, up to 5 years	VascuQoL scores improved significantly from baseline to 30 days and persisted at 12 months across all domains in all groups, paralleling estimates of freedom from major amputation and maintenance of artery patency
Devine (2016)12	323 adults with moderate to severe claudication, multicenter	Medical management (including physician-recommended exercise therapy, smoking cessation, and/or medications) or surgical/endovascular revascularization	ABI	3 domains of modified WIQ (distance, speed, stair-climbing); WIQ pain domain, VascuQoL, EQ-5D, CSI	12 months	At 12 months, both the medical and revascularization groups had improved WIQ, VascuQoL, and EQ-5D scores, and fewer symptoms as measured by CSI, but the revascularization group had greater improvement as compared to medical management alone
McDermott (2018)30 (HONOR study)	200 patients with PAD, multicenter	Usual care or a home-based exercise program with a wearable activity monitor and telephone coaching	6-minute walk distance	Subscales of WIQ, SF-36, and PROMIS	9 months	Exercise intervention was associated with a worse PROMIS pain interference score and a smaller degree of improvement in walking distance

ABI, ankle–brachial index; CLI, critical limb ischemia; CSI, Claudication Symptom Instrument; EQ-5D, EuroQoL-5 Dimensions; EuroQoL, European Quality of Life; FDA, Food and Drug Administration; PAD, peripheral artery disease; PAQ, Peripheral Artery Questionnaire; PROMIS, Patient-Reported Outcomes Measurement Information System; PROMs, patient-reported outcome measures; SET, supervised exercise therapy; SF-12, Short Form-12; SF-36, Short Form-36; VascuQoL, Vascular Quality of Life Questionnaire; WIQ, Walking Impairment Questionnaire.