The reports, issued by the Agency for Healthcare Research and Quality (AHRQ), revealed that in the last 20 years, the diagnosis and treatment of CHD has often excluded or underrepresented both women and minorities, and as a result, the tests and therapies used to treat women with CHD are based on studies conducted predominately in middle-aged men.
"Coronary heart disease is the number-one killer of women, claiming the lives of 250,000 women each year. Yet as a result of the disparity in research, when a woman goes to the doctor for preventive, diagnostic, or therapeutic management of coronary heart disease, her physician must make recommendations on inadequate evidence-based data," said Nanette K. Wenger, M.D., professor of medicine in the division of cardiology at Emory University Medical School.
"These reports are a wake-up call to the medical research community that a revised methodology for clinical research is needed. Studies must be conducted to investigate everyone's unique health needs, including women and minorities. But the only way this can be done is to first include those who have been excluded, and then report results for women and men separately. Even in studies where women have been included, sex-specific data reporting is requisite," said Wenger, vice chair of the Society for Women's Health Research board of directors.
The reports, Results of Systematic Review of Research on Diagnosis and Treatment of Coronary Heart Disease in Women and Diagnosis and Treatment of Coronary Heart Disease in Women: Systematic Reviews of Evidence on Selected Topics, concluded that even though funding agencies appear to have succeeded in ensuring that some women and minorities are included in randomized trials, data about these populations often are not made clear in the published findings. In addition to requiring participation of women and minorities in research, funding and regulatory agencies should request that outcome data by gender, race and ethnicity be published or made easily available.
"These reports showed that even when women were included in studies, researchers did not bother to separate and compare the results for women and men. As a result, physicians still don't have the information they need to take care of their women patients," said Sherry A. Marts, PhD, scientific director of the Society for Women's Health Research.
A May 2000 General Accounting Office (GAO) report supports the findings of the AHRQ reports, stating that although women are now participating in clinical trials in numbers proportionate to their numbers in the general population, data collected in this research are not routinely being analyzed by sex. Without such analysis, clinically relevant information about potentially lifesaving treatments could be lost.
"These reports are testament to the fact that women's health has historically been misunderstood as a result of inadequate research. While the research data may be correct in terms of diagnosis and treatment of diseases for men, there are differences for women and these have not been noted, so doctors are often still treating the two sexes the same," said Phyllis Greenberger, M.S.W., president and CEO of the Society for Women's Health Research.
Last month, the Society for Women's Health Research issued a report that encourages the application of sex analysis early in the clinical research process to more accurately gauge sex-based differences. Published by Medscape, the report, Understanding the Biology of Sex and Gender Differences: Using Subgroup Analysis and Statistical Design to Detect Sex Differences in Clinical Trials, explains how statistical design and subgroup analysis can ensure that drug trials are able to detect any sex differences in response to an investigational drug or device. Visit Medscape to access the report: .http://www.medscape.com/viewarticle/455924.
Details of the AHRQ reports are available online: http://www.ahrq.gov/clinic/epcsums/chdwomsum.htm. (Results of Systematic Review of Research on Diagnosis and Treatment of Coronary Heart Disease in Women) and http://www.ahrq.gov/clinic/epcsums/chdwtopsum.htm. (Diagnosis and Treatment of Coronary Heart Disease in Women: Systematic Reviews of Evidence on Selected Topics.)
The Society for Women's Health Research is the nation's only not-for-profit organization whose sole mission is to improve the health of women through research. Founded in 1990, the Society brought to national attention the need for the appropriate inclusion of women in major medical research studies and the resulting need for more information about conditions affecting women. The Society advocates increased funding for research on women's health, encourages the study of sex differences that may affect the prevention, diagnosis and treatment of disease, and promotes the inclusion of women in medical research studies. Visit the Society's Web site at http://www.womens-health.org for more information.