Barriers to a trial of atherosclerosis prevention in systemic lupus erythematosus.
OBJECTIVE
The effectiveness of aggressive management of traditional risk factors for accelerated atherosclerosis in systemic lupus erythematosus (SLE) has been advocated but not proven. We conducted a pilot, randomized, controlled trial of known prevention medications (pravastatin, ramipril, aspirin, and a combination B vitamin) plus individualized cardiovascular prevention education. We describe our experience in recruiting and retaining patients with SLE in this trial.


METHODS
Patients with SLE by American College of Rheumatology criteria who lived within 1 hour of the hospital and had visits within the past 3 years were screened. All eligible patients were contacted by the principal investigator who was not their physician. The reasons for nonparticipation were elicited in a nonjudgmental manner.


RESULTS
A total of 662 patients met the selection criteria for the study. Of these, 295 patients (45%) with contraindications to study medications were excluded. Ninety-seven (40%) of 244 eligible patients refused to participate. More than 40% of those phoned were unwilling to participate and, among those, 19% felt they were too sick, too well, or taking too many medications already. A total of 41 patients were enrolled in the trial, and 22 dropped out within 4 months.


CONCLUSIONS
SLE is a chronic disease, and the development and testing of interventions aimed at the prevention of long-term sequelae are of paramount importance. Prevention trials in SLE face serious challenges, including the recruitment and retention of participants. Our experience provides insights into the barriers to participation in randomized prevention trials in SLE.
Costenbader
Karen H
KH
Brigham and Women's Hospital, Boston, MA 02115, USA. Kcostenbader@partners.org
Karlson
Elizabeth W
EW
Gall
Victoria
V
de Pablo
Paola
P
Finckh
Axel
A
Lynch
Marsha
M
Bermas
Bonnie
B
Schur
Peter H
PH
Liang
Matthew H
MH
D000924:Anticholesteremic Agents / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001161:Arteriosclerosis / Q000209:etiology / Q000517:prevention & control*; D001241:Aspirin / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008180:Lupus Erythematosus, Systemic / Q000150:complications / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010352:Patient Dropouts; D018579:Patient Selection; D010865:Pilot Projects; D017035:Pravastatin / Q000627:therapeutic use; D017257:Ramipril / Q000627:therapeutic use; D016312:Treatment Refusal; D014803:Vitamin B Complex / Q000008:administration & dosage
D000924:Anticholesteremic Agents; D000959:Antihypertensive Agents; D014803:Vitamin B Complex; D017035:Pravastatin; D017257:Ramipril; D001241:Aspirin