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


CONCLUSIONS
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.
McDermott
Mary M
MM
Northwestern University Feinberg School of Medicine, Chicago, Ill. 60611, USA. mdm608@northwestern.edu
Domanchuk
Kathryn
K
Dyer
Alan
A
Ades
Philip
P
Kibbe
Melina
M
Criqui
Michael H
MH
D000329:Advertising / Q000191:economics; D000368:Aged; D000369:Aged, 80 and over; D002641:Chicago; D003153:Community Health Services; D015709:Correspondence as Topic; D003362:Cost-Benefit Analysis; D005081:Exercise Therapy; D005260:Female; D006801:Humans; D035002:Lower Extremity / Q000098:blood supply*; D008297:Male; D008402:Mass Media / Q000191:economics; D008875:Middle Aged; D015337:Multicenter Studies as Topic / Q000191:economics / Q000379:methods*; D009524:Newspapers as Topic; D018579:Patient Selection; D016491:Peripheral Vascular Diseases / Q000503:physiopathology / Q000628:therapy*; D011845:Radio; D016032:Randomized Controlled Trials as Topic / Q000191:economics / Q000379:methods*; D012039:Regional Blood Flow; D055070:Resistance Training; D016896:Treatment Outcome; D014481:United States; D014493:United States Department of Veterans Affairs; D016138:Walking