Barriers to a trial of atherosclerosis prevention in systemic lupus erythematosus
Article first published online: 5 OCT 2005
Copyright © 2005 by the American College of Rheumatology
Arthritis Care & Research
Volume 53, Issue 5, pages 718–723, 15 October 2005
How to Cite
Costenbader, K. H., Karlson, E. W., Gall, V., Pablo, P. d., Finckh, A., Lynch, M., Bermas, B., Schur, P. H. and Liang, M. H. (2005), Barriers to a trial of atherosclerosis prevention in systemic lupus erythematosus. Arthritis & Rheumatism, 53: 718–723. doi: 10.1002/art.21441
- Issue published online: 5 OCT 2005
- Article first published online: 5 OCT 2005
- Manuscript Accepted: 30 APR 2005
- Manuscript Received: 3 DEC 2004
- NIH. Grant Number: AR47782
- Lupus Clinical Trials Consortium
- Kirkland Scholar Award
- Kirkland Fellowship
- Arthritis Foundation/American College of Rheumatology Physician Scientist Development Award
- Systemic lupus erythematosus;
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.
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.
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.
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.