Representation of Women in Randomized Clinical Trials of Cardiovascular Disease Prevention
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Cardiovascular disease (CVD) is the leading cause of mortality in women. Differences in pathophysiology, diagnosis, and treatment of women with cardiovascular disease compared with men have become a major focus during the past decades. Guideline of CVD prevention in women drew heavily on the results of randomized clinical trials (RCT). However, data from RCT in women was limited, leading to concerns of women been underrepresented in clinical trials from which guidelines were generated. During the past several years, researchers, physicians, and regulators have made substantial efforts to improve understanding of the sex difference in CVD and to recognize the importance of heart disease in women. The purpose of this review is to evaluate contemporary sex differences in CVD disease management, current representation of women in RCT, and examine factors that may improve women’s representation and quality of care in CVD prevention in women.
KeywordsCardiovascular disease Women Randomized clinical trial
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Conflict of Interest
Chiara Melloni declares no conflicts of interest. Lan Shen declares no conflicts of interest.
Human and Animal Rights and Informed Consent
This article does not contain any studies with human or animal subjects performed by the author.
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- 2.Elixhauser A JH. Hospitalizations for women with circulatory disease, 2003.Hcup statistical brief no .5 .Rockville, md: Agency for healthcare research and quality; 2006. 2006;2014Google Scholar
- 3.Us department of health and human services, administration on aging. A profile of older americans: 2011. 2011;2014.Google Scholar
- 6.Blomkalns AL, Chen AY, Hochman JS, Peterson ED, Trynosky K, Diercks DB, et al. Gender disparities in the diagnosis and treatment of non-st-segment elevation acute coronary syndromes: Large-scale observations from the crusade (can rapid risk stratification of unstable angina patients suppress adverse outcomes with early implementation of the american college of cardiology/american heart association guidelines) national quality improvement initiative. J Am Coll Cardiol. 2005;45:832–7.PubMedCrossRefGoogle Scholar
- 9.Health TSfWsHRUSFaDAOoWs. Dialogues on diversifying clinical trials: Successful strategies for engaging women and minorities in clinical trials. 2011.Google Scholar
- 16.Phillips SP. Including gender in public health research. Public Health Rep. 2011;3:16–21.Google Scholar
- 17.Office USGA. Women's health: Fda needs to ensure more study of gender differences in prescription drug testing. (gao/ hrd-93-17). 1992.Google Scholar
- 21.Wizemann TM, Pardue M. Exploring the biological contributions to human health: Does sex matter? Washington, D.C.: National Academy Press; 2001.Google Scholar
- 25.National insitutes of health revitalization act of 1993. Pub. L. No.103-43, 107 stat 122. 1993Google Scholar
- 26.Administration USFaD. Guidance for industry: Collecti of race and ethnicity data in clinical trials. 2005;2014.Google Scholar
- 33.Feinberg J, Saag M, Squires K, Currier J, Ryan R, Coate B, et al. Health-related quality of life in the gender, race, and clinical experience trial. AIDS Res Treat. 2011;349165:28.Google Scholar
- 34.•Falcon R, Bridge DA, Currier J, Squires K, Hagins D, Schaible D, et al. Recruitment and retention of diverse populations in antiretroviral clinical trials: Practical applications from the gender, race and clinical experience study. J Womens Health. 2011;20:1043–50. This study showed the an example of community driven approach of clinical trial.CrossRefGoogle Scholar
- 38.Bushnell C, McCullough LD, Awad IA, Chireau MV, Fedder WN, Furie KL, et al. Guidelines for the prevention of stroke in women: A statement for healthcare professionals from the american heart association/american stroke association. Stroke. 2014;6:6.Google Scholar