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Factors Affecting Rheumatoid Arthritis Patients' Decisions to Participate in Clinical Trials
SUSAN J. LEE, LESLIE LENERT, STUART WEISMAN, and ARTHUR KAVANAUGH
ABSTRACT. Methods. A total of 191 patients with RA were asked to participate in this survey. The questionnaire collected information on demographics, RA disease-related factors, and the importance of several factors that might influence patients' willingness to participate in clinical trials. Patients were then asked if they would consider participating in a hypothetical study. Results. Participants were 88% female with a mean age of 40.5 years. The ethnic composition was 57% Hispanic, 25% Caucasian, 12% Asian, and 6% African American, with 71% having a family income < $20,000/year. Factors that patients considered important for participation in a clinical study included: the opportunity to help others, the possibility of improved health, early access to new therapy, the availability of free treatments, unknown side effects of the study drug, and the need to stop current therapy. There were strong correlations between the rank order importance weights between Hispanics and Caucasians, suggesting fundamental similarities in preferences. The most important factor was the opportunity to help others. In general, the more important factors were associated with preferences for trial participation. Conclusion. This questionnaire identified factors that may affect RA patients' willingness to participate in a study. Patient participation in trials is driven by diverse factors that include altruism and the opportunity for healthcare and improved health. Consideration of these factors may facilitate the inclusion of more diverse patient populations into trials and enhance the applicability of trial results. (J Rheumatol 2005;32:2317-25) Key Indexing Terms:
RHEUMATOID ARTHRITIS
From the Division of Rheumatology, Allergy, Immunology, University of California, San Diego (UCSD), San Diego, California, USA. S.J. Lee, MD, Assistant Clinical Professor, Division of Rheumatology; L. Lenert, MD, MS, Professor of Medicine, Department of Medicine; A. Kavanaugh, MD, Professor of Medicine, Division of Rheumatology, University of California, San Diego; S. Weisman, MD, Rheumatologist, Boulder, Colorado. Address reprint requests to Dr. A. Kavanaugh, 9320 Campus Point Drive, Suite 225, La Jolla, CA 92037-0943. E-mail: akavanaugh@ucsd.edu Accepted for publication June 27, 2005. |