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Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies: Volume 2: Workshop and Commissioned Papers (1994) / Chapter Skim
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6 Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (I)
Pages 35-40

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From page 35...
... Failure to conduct sufficient research on these conditions is a special case of exclusion of women from clinical studies and may result in significant gaps in knowledge and in health services for women. If we use as a standard the number of women potentially affected by a condition, then the most obvious infonnation needs pertain to the prevention and treatment of conditions associated with the female reproductive organs and with normal female aging (including menopause)
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From page 36...
... For example, there are numerous information deficits for prevention and treatment of heart disease in women, in part because women were excluded from a number of key trials (e.g., the Lipid Research Clinics Coronary Primary Prevention Trial, the Multiple Risk Factor Intervention Trial, and the Physicians' Health Study3. The efficacy of hormone replacement therapy in prevention of heart disease in women is one question requiring further research.5 TYPES OF CONSEQUENCES If there were overall negative health consequences to women as a result of infonnation deficits, we would expect to see them reflected in gender differences in morbidity and mortality; in gender differences in patterns of diagnosis and treatment for key conditions; in gender differences in survival or outcomes of treatments; or in providers' perceptions that their ability to provide optimal care to women patients is compromised.
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From page 37...
... Most noteworthy are studies of access among patients with kidney disease to dialysis and transplantation; of diagnosis of lung cancer by sputum cytology; and of diagnosis and treatment of heart disease.~5 Several studies find that women with heart disease may be diagnosed later than men (possibly because tests such as the treadmill exercise test are less effective in women) and that women are less likely than men to have invasive procedures such as coronary angiography, coronary angioplasty, or coronary artery bypass surgery, after relevant covariates such as age and severity are controlled.
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From page 38...
... recommends the same approach to management of hypertension in women and men, although it concludes that further study is warranted and identifies some gaps in knowledge (e.g., effects of hormone replacement therapy on blood pressure) .22 The recommendation for a similar management approach for women and men has been criticized in part because of missing information on the effects of antihypertensive agents on serum lipids in women.23 With regard to primary prevention of hypertension, however, JNC V does not address gender differences in risk factors (e.g., diet, physical activity, stress levels3 or in the efficacy of interventions.24 The report of the 1992 NIH Consensus Development Conference on Triglyceride, High-Density Lipoprotein, and Coronary Heart Disease acknowledges information gaps with regard to women and calls specifically for studies of the effects of estrogen and progesterone use on lipids and on risk of coronary heart disease in women.25 CONCLUSIONS Evidence has been provided that exclusion or underrepresentation of women in clinical studies results in some important information deficits, particularly for the leading causes of morbidity and mortality in women, and that these deficits may adversely affect women's health.
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From page 39...
... Martin, and Douglas Weaver, "Gender Differences in the Treatment and Outcome of Acute Myocardial Infarction," Arch Ives of Internal Medicine 152:972-976, 1992.
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From page 40...
... Johnson, et al., "Percutaneous Transluminal Coronary Angioplasty in New York State," JAMA 268:3092-3097, 1992; Eysmann, Susan B., "Reperfusion and Revascularization Strategies for Coronary Artery Disease in Women,"JAMA 268:1903-1907, 1992; Sheryl F Kelsey, Margaret James, Ann Lu Holubkov, et al., "Results of Percutaneous Transluminal Coronary Angioplasty in Women: 1985-1986 National Heart, Lung, and Blood Institute's Coronary Angioplasty Registry," Circulation 87:720-727,1993.
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Key Terms

  • clinical studies
  • blood pressure
  • gender differences
  • coronary artery
  • information deficits

  • coronary heart
  • artery bypass
  • coronary angioplasty
  • health research
  • national committee

  • primary prevention
  • joint national
  • health consequences
  • risk factors
  • ischemic heart

  • education program
  • women patients
  • bypass surgery
  • reproductive age
  • mortality rates

  • lung cancer
  • leading causes
  • replacement therapy
  • hormone replacement
  • pressure education

  • fifth report
  • percutaneous transluminal
  • transluminal coronary
  • key risk
  • information gaps


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