Sex Differences in Perceived Risks, Distrust, and Willingness to Participate in Clinical Trials
Ding, Eric L.
Powe, Neil R.
Manson, JoAnn E.
Sherber, Noëlle S.
Braunstein, Joel B.
Archives of Internal Medicine 2007 May 14; 167(9): 905-912
Background: Multiple sex differences exist in cardiovascular disease burden and treatment efficacies; adequate participation of both sexes is crucial to clinical research. Methods: A multicenter, double-blind, randomized study evaluated sex and trial scenarios on willingness to participate (WTP) in cardiovascular prevention trials and examined sex differences in perceived risks and distrust. Hypothetical trial scenarios randomized multifactorial vignettes of adverse effects, trial durations, sponsors, financial incentives, and conflicts of interest. Results: With 783 participants across 13 clinical centers, women showed lower distrust of medical researchers, perceived greater risk of myocardial infarction, and perceived greater risk of harm from trial participation than men. Men had 15% greater WTP than women (33.1% vs 28.7%; relative risk [RR], 1.15; 95% confidence interval [CI], 1.02-1.31); adjusting for explanatory mediators, we found that sex differences in perceived risks and benefits explained the sex gap in WTP. Although greater perceived probability of harm (RR, 0.41; 95% CI, 0.23-0.72), health benefit (RR, 2.99; 95% CI, 1.63-5.46), and quality of care (RR, 1.71; 95% CI, 1.12-2.61) strongly predicted WTP (for perceived probabilities 80% vs
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