Table 3Inclusion and exclusion criteria

Study CharacteristicInclusion CriteriaExclusion Criteria
PopulationAdult patients (≥18 years of age) with lower extremity PAD (e.g., ABI <0.9) who are asymptomatic or symptomatic (atypical leg symptoms, IC, or CLI)
  • Patients with PAD, but results are not reported separately for the subgroup with lower extremity PAD
  • All patients are <18 years of age, or some patients are <18 years of age, but results are not broken down by age
Interventions and comparators
  • KQ 1: Two or more antiplatelet agents (aspirin or clopidogrel)
    • Exercise training vs. medications (cilostazol, pentoxifylline)
    • Exercise training vs. endovascular intervention (percutaneous transluminal arterial angioplasty, atherectomy, stenting)
    • Exercise training vs. surgical revascularization (endarterectomy, bypass surgery)
    • Medications vs. endovascular intervention
    • Medications vs. surgical revascularization
    • Usual care vs. another treatment modality (exercise training, medications, endovascular intervention, or surgical revascularization)
    • Endovascular intervention (percutaneous transluminal arterial angioplasty, atherectomy, stenting) vs. surgical revascularization (endarterectomy, bypass surgery)
    • Usual care vs. endovascular intervention
    • Usual care vs. surgical revascularization
  • Interventions not listed in KQs 13 (e.g., studies of tobacco cessation, statins, and were excluded since treatment of cardiovascular risk factors is considered standard therapy across the treatment strategies assessed in this report)
  • KQ 1: No active comparator (but placebo-controlled trials and studies comparing one antiplatelet agent with another antiplatelet agent are included); also excluded:
    • Studies of ticlopidine (no longer prescribed due to hematologic side effects)
    • Studies comparing anticoagulants (warfarin, low molecular weight heparin) with antiplatelet agents to prevent postrevascularization thrombosis
  • KQ 2 and KQ 3: No active comparator (but studies comparing usual care or placebo with another treatment are included), or comparisons of two treatments of the same type (i.e., one type of exercise vs. another type of exercise; endovascular approach vs. another endovascular approach; surgical approach vs. another surgical approach)
OutcomesKQs 13:
  • Functional capacity (e.g., PWT, MWD or PFWD, COT, and initial or ACD)
  • Quality of life (e.g., Short-Form 36, EuroQOL-5D, Walking Impairment Questionnaire, Peripheral Artery Questionnaire)
  • Vessel patency (primary, primary assisted, or secondary)
  • Repeat revascularization
  • Amputation
  • Wound healing
  • Analog pain scale score
  • Cardiovascular events (e.g., all-cause mortality, MI, stroke, cardiovascular death)
No primary or secondary outcomes of interest are reported
Outcomes (safety)KQs 13: Intervention-related safety and adverse effects including adverse drug reactions, bleeding, contrast nephropathy, radiation, infection, exercise-related harms, and periprocedural complications causing acute limb ischemiaNone
TimingShort term (30 days), intermediate term (31 days to 1 year), and long term (>1 year)Treatment or followup of <30 days
SettingInpatient and outpatientNone
Study design
  • Randomized controlled trial, prospective or retrospective observational cohort study
  • Relevant systematic review or meta-analysis (used for background only)
  • Original data (or related methodology paper of an included article) for interventions listed in KQs 13
  • All sample sizes
Not a clinical study (e.g., editorial, non–systematic review, letter to the editor, case series)
  • English-language only
  • Peer-reviewed article
  • Published January 1, 1995, to present
Given the high volume of literature available in English-language publications (including the majority of known important studies), non-English articles were excluded

Abbreviations: ABI=ankle-brachial index; ACD=absolute claudication distance; COT=claudication onset time; KQ=Key Question; PAD=peripheral artery disease; PWT=peak walking time; PFWD=pain-free walking distance.

From: Methods

Cover of Treatment Strategies for Patients With Peripheral Artery Disease
Treatment Strategies for Patients With Peripheral Artery Disease [Internet].
Comparative Effectiveness Reviews, No. 118.
Jones WS, Schmit KM, Vemulapalli S, et al.

NCBI Bookshelf. A service of the National Library of Medicine, National Institutes of Health.