Recruiting participants with peripheral arterial disease for clinical trials: experience from the Study to Improve Leg Circulation (SILC)

J Vasc Surg. 2009 Mar;49(3):653-659.e4. doi: 10.1016/j.jvs.2008.10.030. Epub 2009 Jan 9.

Abstract

Objective: To describe the success of diverse recruitment methods in a randomized controlled clinical trial of exercise in persons with peripheral arterial disease (PAD).

Methods: An analysis of recruitment sources conducted for the 746 men and women completing a baseline visit for the study to improve leg circulation (SILC), a randomized controlled trial of exercise for patients with PAD. For each recruitment source, we determined the number of randomized participants, the rate of randomization among those completing a baseline visit, and cost per randomized participant.

Results: Of the 746 individuals who completed a baseline visit, 156 were eligible and randomized. The most frequent sources of randomized participants were newspaper advertising (n = 67), mailed recruitment letters to patients with PAD identified at the study medical center (n = 25), and radio advertising (n = 18). Costs per randomized participant were $2750 for television advertising, $2167 for Life Line Screening, $2369 for newspaper advertising, $3931 for mailed postcards to older community dwelling men and women, and $5691 for radio advertising. Among those completing a baseline visit, randomization rates ranged from 10% for those identified from radio advertising to 32% for those identified from the Chicago Veterans Administration and 33% for those identified from posted flyers.

Conclusion: Most participants in a randomized controlled trial of exercise were recruited from newspaper advertising and mailed recruitment letters to patients with known PAD. The highest randomization rates after a baseline visit occurred among participants identified from posted flyers and mailed recruitment letters to PAD patients.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Advertising* / economics
  • Aged
  • Aged, 80 and over
  • Chicago
  • Community Health Services
  • Correspondence as Topic
  • Cost-Benefit Analysis
  • Exercise Therapy*
  • Female
  • Humans
  • Lower Extremity / blood supply*
  • Male
  • Mass Media* / economics
  • Middle Aged
  • Multicenter Studies as Topic / economics
  • Multicenter Studies as Topic / methods*
  • Newspapers as Topic
  • Patient Selection*
  • Peripheral Vascular Diseases / physiopathology
  • Peripheral Vascular Diseases / therapy*
  • Radio
  • Randomized Controlled Trials as Topic / economics
  • Randomized Controlled Trials as Topic / methods*
  • Regional Blood Flow
  • Resistance Training
  • Treatment Outcome
  • United States
  • United States Department of Veterans Affairs
  • Walking