title: Using vascular quality initiative as a platform for organizing multicenter, prospective, randomized clinical trials: OVERPAR trial.
abstract: BACKGROUND
  We describe the organization of a prospective, randomized, multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair (OPAR) and endovascular popliteal artery aneurysm repair (EPAR) of asymptomatic popliteal artery aneurysms (PAAs) as an example for how to use the Vascular Quality Initiative (VQI) framework. Given that many centers participate in the VQI, this model can be used to perform multicenters' prospective trials on very modest budget.
  
  
  METHODS
  VQI prospectively collects data on many vascular procedures. These data include many important perioperative, intraoperative, and postoperative details regarding both patients and their procedures. We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question. Data will be collected using modified VQI forms within the existing VQI data reporting structure. We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts. Patients from participating VQI centers will be randomized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years. Our primary hypothesis is that major adverse limb event-free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions, improved quality of life, and decreased length of stay. The budget for this trial is fixed at $10,000/year for the course of the study, and the trial is judged to be feasible because of the functionality of the VQI platform.
  
  
  CONCLUSIONS
  Using the existing VQI infrastructure, Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget. The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates.
authors.affiliation: Division of Vascular and Endovascular Surgery, Boston University School of Medicine, Boston, MA. Electronic address: Mohammad.eslami@bmc.org.
authors.forename: Mohammad H
authors.initials: MH
authors.lastname: Eslami
authors.affiliation: Department of Biostatistics, Boston University School of Public Health, Boston, MA.
authors.forename: Gheorghe
authors.initials: G
authors.lastname: Doros
authors.affiliation: Division of Vascular and Endovascular Surgery, Dartmouth School of Medicine, Lebanon, NH.
authors.forename: Philip P
authors.initials: PP
authors.lastname: Goodney
authors.affiliation: Division of Vascular and Endovascular Surgery, Maine Medical Center, Portland, ME.
authors.forename: Jens
authors.initials: J
authors.lastname: Elderup-Jorgenson
authors.affiliation: Division of Vascular and Endovascular Surgery, Dartmouth School of Medicine, Lebanon, NH.
authors.forename: Jack L
authors.initials: JL
authors.lastname: Cronenwett
authors.affiliation: Division of Vascular and Endovascular Surgery, Boston University School of Medicine, Boston, MA.
authors.forename: Marina
authors.initials: M
authors.lastname: Malikova
authors.affiliation: Division of Vascular and Endovascular Surgery, Boston University School of Medicine, Boston, MA.
authors.forename: Alik
authors.initials: A
authors.lastname: Farber
mesh_terms: D000671:Amputation, Surgical; D000783:Aneurysm / Q000175:diagnosis / Q000191:economics / Q000601:surgery*; D058070:Asymptomatic Diseases; D019917:Blood Vessel Prosthesis Implantation / Q000009:adverse effects / Q000191:economics / Q000592:standards*; D002017:Budgets; D019091:Critical Pathways / Q000592:standards; D018572:Disease-Free Survival; D057510:Endovascular Procedures / Q000009:adverse effects / Q000191:economics / Q000592:standards*; D019317:Evidence-Based Medicine / Q000191:economics / Q000592:standards*; D006801:Humans; D007902:Length of Stay; D023821:Limb Salvage; D011150:Popliteal Artery / Q000601:surgery*; D011446:Prospective Studies; D019984:Quality Indicators, Health Care / Q000191:economics / Q000592:standards*; D011788:Quality of Life; D012107:Research Design / Q000592:standards*; D012109:Research Support as Topic; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States