title: Effectiveness of a Medical vs Revascularization Intervention for Intermittent Leg Claudication Based on Patient-Reported Outcomes.
abstract: Intermittent claudication (IC) is the most common presentation of infrainguinal peripheral artery disease. Both medical and revascularization interventions for IC aim to increase walking comfort and distance, but there is inconclusive evidence of the comparative benefit of revascularization given the possible risk of limb loss.
  
  
  
  To compare the effectiveness of a medical (walking program, smoking cessation counseling, and medications) vs revascularization (endovascular or surgical) intervention for IC in the community, focusing on outcomes of greatest importance to patients.
  
  
  
  Longitudinal (12-month follow-up) prospective observational cohort study conducted between July 3, 2011, and November 5, 2014, at 15 clinics associated with 11 hospitals in Washington State. Participants were 21 years or older with newly diagnosed or established IC.
  
  
  
  Medical or revascularization interventions.
  
  
  
  Primary end points were 12-month change scores on the distance, speed, and stair-climb domains of the Walking Impairment Questionnaire (score range, 0-100). Secondary outcomes were change scores on the Walking Impairment Questionnaire pain domain (score range, 0-100), Vascular Quality of Life Questionnaire (VascuQol) (score range, 1-7), European Quality of Life-5 Dimension Questionnaire (EQ-5D) (score range, 0-1), and Claudication Symptom Instrument (CSI) (score range, 0-4).
  
  
  
  A total of 323 adults were enrolled, with 282 (87.3%) in the medical cohort. At baseline, the mean duration of disease was longer for participants in the medical cohort, while those in the revascularization cohort reported more severe disease. Other characteristics were well balanced. At 12 months, change scores in the medical cohort reached significance for the following 3 outcomes: speed (5.9; 95% CI, 0.5-11.3; P = .03), VascuQol (0.28; 95% CI, 0.08-0.49; P = .008), and EQ-5D (0.038; 95% CI, 0.011-0.066; P = .006). In the revascularization cohort, there were significant improvements in the following 7 outcomes: distance (19.5; 95% CI, 7.9-31.0; P = .001), speed (12.1; 95% CI, 1.4-22.8; P = .03), stair climb (11.4; 95% CI, 1.3-21.5; P = .03), pain (20.7; 95% CI, 11.0-30.4; P < .001), VascuQol (1.10; 95% CI, 0.80-1.41; P < .001), EQ-5D (0.113; 95% CI, 0.067-0.159; P < .001), and CSI (-0.63; 95% CI, -0.96 to -0.31; P < .001). Relative improvements (percentage changes) at 12 months in the revascularization cohort over the medical cohort were observed as follows: distance (39.1%), speed (15.6%), stair climb (9.7%), pain (116.9%), VascuQol (41%), EQ-5D (18%), and CSI (13.5%).
  
  
  
  Among patients with IC, those in the revascularization cohort had significantly improved function (Walking Impairment Questionnaire), better health-related quality of life (VascuQol and EQ-5D), and fewer symptoms (CSI) at 12 months compared with those in the medical cohort, providing important information to inform treatment strategies in the community.
authors.affiliation: Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle2Surgical Outcomes Research Center, University of Washington, Seattle3Department of Health Services, University of Washington, Seattle4Department of Biomedical Informatics, University of Washington, Seattle5Centers for Comparative and Health Systems Effectiveness (CHASE) (CHASE Alliance), University of Washington, Seattle.
authors.forename: Emily B
authors.initials: EB
authors.lastname: Devine
authors.affiliation: Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle2Surgical Outcomes Research Center, University of Washington, Seattle5Centers for Comparative and Health Systems Effectiveness (CHASE) (CHASE Alliance), University of Washington, Seattle.
authors.forename: Rafael
authors.initials: R
authors.lastname: Alfonso-Cristancho
authors.affiliation: Department of Biostatistics, University of Washington, Seattle7School of Public Health, Oregon Health & Science University, Portland.
authors.forename: N David
authors.initials: ND
authors.lastname: Yanez
authors.affiliation: Department of Health Services, University of Washington, Seattle5Centers for Comparative and Health Systems Effectiveness (CHASE) (CHASE Alliance), University of Washington, Seattle8Seattle Quality of Life Group, University of Washington, Seattle.
authors.forename: Todd C
authors.initials: TC
authors.lastname: Edwards
authors.affiliation: Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle3Department of Health Services, University of Washington, Seattle5Centers for Comparative and Health Systems Effectiveness (CHASE) (CHASE Alliance), University of Washington, Seattle8Seattle Quality of Life Group, University of Washington, Seattle.
authors.forename: Donald L
authors.initials: DL
authors.lastname: Patrick
authors.affiliation: Surgical Outcomes Research Center, University of Washington, Seattle.
authors.forename: Cheryl A L
authors.initials: CA
authors.lastname: Armstrong
authors.affiliation: Surgical Outcomes Research Center, University of Washington, Seattle5Centers for Comparative and Health Systems Effectiveness (CHASE) (CHASE Alliance), University of Washington, Seattle.
authors.forename: Allison
authors.initials: A
authors.lastname: Devlin
authors.affiliation: Surgical Outcomes Research Center, University of Washington, Seattle.
authors.forename: Rebecca G
authors.initials: RG
authors.lastname: Symons
authors.affiliation: Department of Surgery, University of Washington, Seattle.
authors.forename: Mark H
authors.initials: MH
authors.lastname: Meissner
authors.affiliation: Providence Everett Medical Center, Everett, Washington.
authors.forename: Ellen L T
authors.initials: EL
authors.lastname: Derrick
authors.affiliation: Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle2Surgical Outcomes Research Center, University of Washington, Seattle5Centers for Comparative and Health Systems Effectiveness (CHASE) (CHASE Alliance), University of Washington, Seattle.
authors.forename: Danielle C
authors.initials: DC
authors.lastname: Lavallee
authors.affiliation: Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle3Department of Health Services, University of Washington, Seattle5Centers for Comparative and Health Systems Effectiveness (CHASE) (CHASE Alliance), University of Washington, Seattle.
authors.forename: Larry G
authors.initials: LG
authors.lastname: Kessler
authors.affiliation: Pharmaceutical Outcomes Research and Policy Program, University of Washington, Seattle2Surgical Outcomes Research Center, University of Washington, Seattle3Department of Health Services, University of Washington, Seattle5Centers for Comparative and Health Systems Effectiveness (CHASE) (CHASE Alliance), University of Washington, Seattle.
authors.forename: David R
authors.initials: DR
authors.lastname: Flum
mesh_terms: D000368:Aged; D055109:Ankle Brachial Index; D005260:Female; D006801:Humans; D007383:Intermittent Claudication / Q000453:epidemiology / Q000601:surgery / Q000628:therapy*; D007866:Leg / Q000098:blood supply*; D008297:Male; D008875:Middle Aged; D000071066:Patient Reported Outcome Measures; D015995:Prevalence; D011446:Prospective Studies; D011788:Quality of Life; D012307:Risk Factors; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures