Sex, Region, and Outcomes After Revascularization
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The importance of both sex and gender in biological research was highlighted by a report in 2000 from the Institute of Medicine, “Exploring the Biological Contributions to Human Health: Does Sex Matter?”1 This landmark report not only clarified the use of the terms sex (“…a classification, generally as male or female, according to the reproductive organs and functions that derive from the chromosomal complement.”) and gender (“…a person’s self-representation as male or female, or how that person is responded to by social institutions on the basis of the individual’s gender presentation.”) but also addressed the important role that both sex and gender play in health and the development of disease, healthcare delivery, and response to treatment. Furthermore, there were strong recommendations for an increased emphasis on design of studies, so they can be analyzed by sex with adequate power and for a requirement to present the results of studies according to sex in the medical literature. Despite this Institute of Medicine report and the 1993 National Institutes of Health Revitalization Act2,3 that mandated representation of women and men in clinical trials in proportion to the sex-related prevalence of the disease under study, several reports have shown that enrollment of women continues to lag behind their representation among patients with or at risk for cardiovascular disease.4–6 At the same time, increased reporting of the results of clinical trials according to sex leaves the medical community faced with the challenge of interpreting the results of these underpowered subgroup analyses and how to apply them in practice.
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