Table 1 Study PICOS framework

P

Adults (≥ 18 years) diagnosed with PAD, critical limb ischemia, intermittent claudication, severe limb ischemia, or chronic limb-threatening ischemia

I

LE endovascular interventions for femoral/popliteal/tibial (percutaneous transluminal angioplasty (PTA), drug-eluting stent (DES), drug-coated balloon (DCB), and bare-metal stent (BMS)) in one treatment arm

C

LE endovascular interventions for femoral/popliteal/tibial (PTA, DES, DCB, and BMS)

O

i. Primary outcomes: Eligibility criteria of patients (inclusion and exclusion criteria); baseline demographic characteristics of patients enrolled and excluded (age, race/ethnicity, sex, etc.); and baseline clinical characteristics of patients enrolled and excluded (intermittent claudication, critical limb ischemia, Rutherford classification, diabetes, etc.)​

ii. Secondary outcomes: Reporting of outcomes by demographic characteristics (sex, race, etc.); enrollment/recruitment strategies (adaptive and targeted such as online, community, academic, etc.), participant facing-materials (availability of materials in other languages, including consent processes), diversification of trial investigators, trial protocols (inclusion of patient-centered processes), and patient reimbursement.​

S

Global (all countries)