Women's Health Research Progress, Pitfalls, and Promise (2010) / Chapter Skim
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4 Methodologic Issues in Women's Health Research
4 Methodologic Issues in Women's Health Research
Pages 221-240
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From page 221... ...
The Women's Health Initiative (WHI) is then discussed as an ex ample of what has been learned about methods of women's health research from the studies already conducted.
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From page 222... ...
. The random ized clinical trial in the WHI identified a risk of heart disease to be associated with combination estrogen hormone therapy, which was previously thought to be cardioprotective, and it confirmed the risk of breast cancer, venous thromboem bolism, and stroke.
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From page 223... ...
. For example, the first randomized clinical trial of estrogen therapy, the Coronary Drug Project, was done in men.
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Of the women who were eligible to participate in the largest cohort study of HIV-infected women in the United States (the Women's Interagency HIV Study) , about half would have been ineligible, on the basis of exclusion criteria, to participate in 20 of the AIDS Clinical Trials Group stud ies, which are among the largest HIV clinical-trial groups in the United States (Gandhi et al., 2005)
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. A review of the literature by the Agency for Healthcare Research and Quality indicated that studies of coronary heart disease rarely included women in adequate numbers for analysis of the data by sex (Grady et al., 2003)
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From page 226... ...
For example, the original Physicians Health Study was a randomized controlled trial in men that found that daily aspirin led to a significant reduction in myocardial infarc tion but not in cardiovascular death (Hennekens and Buring, 1989; Hennekens and Eberlein, 1985)
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From page 227... ...
. If a clinical trial looking at a cardiovascular-disease treatment assesses fatal and nonfatal myocardial infarction as its outcome but does not assess such events as unstable angina that are more common in women, it will underestimate the prevalence of cardiovascular disease in women and be biased against finding a treatment effect in women.
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ANALYSIS Including adequate numbers of women in clinical trials is necessary but not sufficient to ensure that results are applicable to women. Despite improved inclu sion of women in trials funded by NIH and reviewed by FDA, there has been a lag in the routine analysis and reporting of data by sex (GAO, 2000, 2001)
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From page 229... ...
; data from individual studies and pooled data from observational studies, such as the NHS, found a significantly lower risk of coronary heart disease in postmenopausal women who were on estrogen alone (Barrett-Connor and Grady, 1998; Grady et al., 1992; Grodstein et al., 1996, 2000; Stampfer and Colditz, 1991) ; and data from a randomized controlled trial (the Postmenopausal Estrogen/Progestin Interventions [PEPI]
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From page 230... ...
study, which examined lipid concentrations, angiographic end points, and cardiovascular events -- did not show that estrogen plus progestin prevented further heart attacks or death from coronary heart disease in postmenopausal women who had heart disease and, in the case of HERS, actually resulted in a higher rate of coronary heart disease soon after initiation of treatment (Grady et al., 2000; Herrington et al., 2000; Hulley et al., 1998)
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From page 231... ...
Etiology and risk factors can be investigated with well-designed and well-executed observational studies that measure and adjust for known confounders, ensure appropriate ascertainment of end points (especially coronary heart disease, whose ascertainment is more challenging) , and use appropriate statistical techniques to analyze data.
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From page 232... ...
For example, the results of observational studies that reported on the effect of hormone therapy on lipids were interpreted as proxy evidence of their effect on coronary–heart-disease end points, but this was not confirmed or supported in randomized controlled trials that examined these end points. Single-sex studies like the WHI can provide valuable information and fill in research gaps -- especially in, for example, coronary heart disease -- in clinical trials where women have been underrepresented.
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Sex and gender differences in the manifestation of disease should be con sidered in the design of research to incorporate the spectrum of outcomes that are relevant to women. Government and other funding agencies should ensure adequate participation of women and reporting of sex stratified analyses in health research.
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2004. Effects of conjugated equine estrogen in postmenopausal women with hysterectomy: The women's health initiative random ized controlled trial.
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1998. Effect of postmenopausal hormone therapy on lipoprotein(a)
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2008. Observational studies analyzed like randomized experiments: An application to postmenopausal hormone therapy and coronary heart disease.
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1998. Ran domized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women.
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1991. Estrogen replacement therapy and coronary heart disease: A quantitative assessment of the epidemiologic evidence.
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2008. Observational data and clinical trials: Narrowing the gap?
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