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A Randomized Study of Cardiovascular Prevention Trials

Eric L. Ding, BA; Neil R. Powe, MD, MPH, MBA; JoAnn E. Manson, MD, DrPH; Noëlle S. Sherber, MD; Joel B. Braunstein, MD, MBA

Arch Intern Med. 2007;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 <20%) similarly in both sexes, and perceptions of distrust and myocardial infarction risk predicted WTP differently between sexes (P.01 for interactions), age, history of coronary artery disease, hypertension, and diabetes mellitus increased WTP in men but not in women (P.05 for sex interactions). Compared with no financial conflict, disclosure of investigator patent ownership increased WTP in women, while it decreased WTP in men (P = .02 for sex interaction). Monetary incentives were overall more effective on WTP in women (P = .03 for sex interaction).

Conclusions  In this multicenter study, women perceived greater risk of harm and myocardial infarction and showed lower WTP in cardiovascular prevention trials. Evidence underscores the importance of sex in influencing clinical trial enrollment.

Author Affiliations: Departments of Epidemiology (Mr Ding and Dr Manson) and Nutrition (Mr Ding), Harvard School of Public Health, and Division of Preventive Medicine (Mr Ding and Dr Manson), Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass; Welch Center for Prevention, Epidemiology, and Clinical Research (Dr Powe), Division of General Internal Medicine (Dr Powe), Department of Medicine (Drs Powe and Sherber), Johns Hopkins School of Medicine, and Department of Epidemiology, Johns Hopkins Bloomberg School of Public Health (Dr Powe), Baltimore, Md; Department of Medicine, Columbia University, College of Physicians and Surgeons, New York, NY (Dr Sherber); and Center for Outcomes Research and Evaluation, Yale School of Medicine, New Haven, Conn (Dr Braunstein).

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