Risk of Obstructive Sleep Apnea: Sex Matters
Research on sex-specific aspects of cardiovascular disease and its prevention has been hampered on many fronts. In the past, women were excluded from clinical research studies as a result of efforts to protect them from risk. In 1985, the US Public Health Service Task Force on Women's Health Issues concluded that this exclusion of women from clinical trials had led to a lack of sufficient knowledge about women's biology and that this had compromised the health of women.1 The National Institutes of Health (NIH) changed its policy on the inclusion of women of childbearing age in clinical research in 1986.2 In 1990, a General Accounting Office (GAO) report examined change in the inclusion of women in NIH-sponsored research and found that the NIH guidelines were not being followed as the number of women included had not appreciably improved.3 The report also noted that even in those studies that included women, sex-specific analysis was rarely undertaken or reported. The GAO report led to the establishment of the NIH Office on Research on Women's Health to ensure that women are included in NIH-funded clinical studies unless a clear justification existed for their exclusion. Guidelines established stated that the NIH would ensure that trials were designed and performed in such a manner that sex-specific results could be validly analyzed and that progress reports be required.4 The passage of the NIH Revitalization Act in 1993 turned these guidelines into law.5 In addition to requiring the inclusion of women and minorities in clinical trials, the Act stipulated that cost could not be used as an excuse for excluding these groups and that outreach efforts be put in place for recruitment.
- Received August 24, 2015.
- Accepted August 26, 2015.