An Assessment Of The Nih Women S Health Initiative

The National Institutes of Health Women's Health Initiative (WHI) is the largest research study ever funded by NIH ($625 million over 14 years) and is designed to test strategies to prevent cardiovascular disease, breast cancer, and osteoporotic fracturesâ€"leading causes of death, disability, and decreased quality of life for older women. Although the WHI has already begun, serious questions remain about its design, cost, and the likelihood that it can answer the questions it asks. This book evaluates whether the effort can be justified scientifically.

Even though slightly over half of the U.S. population is female, medical research historically has neglected the health needs of women. However, over the past two decades, there have been major changes in government support of women's health research-in policies, regulations, and the organization of research efforts. To assess the impact of these changes, Congress directed the Department of Health and Human Services (HHS) to ask the IOM to examine what has been learned from that research and how well it has been put into practice as well as communicated to both providers and women. Women's Health Research finds that women's health research has contributed to significant progress over the past 20 years in lessening the burden of disease and reducing deaths from some conditions, while other conditions have seen only moderate change or even little or no change. Gaps remain, both in research areas and in the application of results to benefit women in general and across multiple population groups. Given the many and significant roles women play in our society, maintaining support for women's health research and enhancing its impact are not only in the interest of women, they are in the interest of us all.

In 1950 men and women in the United States had a combined life expectancy of 68.9 years, the 12th highest life expectancy at birth in the world. Today, life expectancy is up to 79.2 years, yet the country is now 28th on the list, behind the United Kingdom, Korea, Canada, and France, among others. The United States does have higher rates of infant mortality and violent deaths than in other developed countries, but these factors do not fully account for the country's relatively poor ranking in life expectancy. International Differences in Mortality at Older Ages: Dimensions and Sources examines patterns in international differences in life expectancy above age 50 and assesses the evidence and arguments that have been advanced to explain the poor position of the United States relative to other countries. The papers in this deeply researched volume identify gaps in measurement, data, theory, and research design and pinpoint areas for future high-priority research in this area. In addition to examining the differences in mortality around the world, the papers in International Differences in Mortality at Older Ages look at health factors and life-style choices commonly believed to contribute to the observed international differences in life expectancy. They also identify strategic opportunities for health-related interventions. This book offers a wide variety of disciplinary and scholarly perspectives to the study of mortality, and it offers in-depth analyses that can serve health professionals, policy makers, statisticians, and researchers.

In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues. Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies. Leading experts present general principles for the ethical conduct of research on womenâ€"principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research. Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research. The book addresses present-day challenges to equity in four areas: Scientificâ€"Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics. Social and Ethicalâ€"The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants. Legalâ€"Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases. Riskâ€"The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed. This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

Healthcare decision makers in search of reliable information that compares health interventions increasingly turn to systematic reviews for the best summary of the evidence. Systematic reviews identify, select, assess, and synthesize the findings of similar but separate studies, and can help clarify what is known and not known about the potential benefits and harms of drugs, devices, and other healthcare services. Systematic reviews can be helpful for clinicians who want to integrate research findings into their daily practices, for patients to make well-informed choices about their own care, for professional medical societies and other organizations that develop clinical practice guidelines. Too often systematic reviews are of uncertain or poor quality. There are no universally accepted standards for developing systematic reviews leading to variability in how conflicts of interest and biases are handled, how evidence is appraised, and the overall scientific rigor of the process. In Finding What Works in Health Care the Institute of Medicine (IOM) recommends 21 standards for developing high-quality systematic reviews of comparative effectiveness research. The standards address the entire systematic review process from the initial steps of formulating the topic and building the review team to producing a detailed final report that synthesizes what the evidence shows and where knowledge gaps remain. Finding What Works in Health Care also proposes a framework for improving the quality of the science underpinning systematic reviews. This book will serve as a vital resource for both sponsors and producers of systematic reviews of comparative effectiveness research.

The U.S. Food and Drug Administration (FDA) has approved dozens of hormone therapy products for men and women, including estrogen, progesterone, testosterone, and related compounds. These products have been reviewed for safety and efficacy and are indicated for treatment of symptoms resulting from hormonal changes associated with menopause or other endocrine-based disorders. In recent decades, an increasing number of health care providers and patients have turned to custom-formulated, or compounded, drug preparations as an alternative to FDA-approved drug products for hormone-related health concerns. These compounded hormone preparations are often marketed as "bioidentical" or "natural" and are commonly referred to as compounded bioidentical hormone therapy (cBHT). In light of the fast-growing popularity of cBHT preparations, the clinical utility of these compounded preparations is a substantial public health concern for various stakeholders, including medical practitioners, patients, health advocacy organizations, and federal and state public health agencies. This report examines the clinical utility and uses of cBHT drug preparations and reviews the available evidence that would support marketing claims of the safety and effectiveness of cBHT preparations. It also assesses whether the available evidence suggests that these preparations have clinical utility and safety profiles warranting their clinical use and identifies patient populations that might benefit from cBHT preparations in lieu of FDA-approved BHT.

Even though slightly over half of the U.S. population is female, medical research historically has neglected the health needs of women. However, over the past two decades, there have been major changes in government support of women's health research-in policies, regulations, and the organization of research efforts. To assess the impact of these changes, Congress directed the Department of Health and Human Services (HHS) to ask the IOM to examine what has been learned from that research and how well it has been put into practice as well as communicated to both providers and women. Women's Health Research finds that women's health research has contributed to significant progress over the past 20 years in lessening the burden of disease and reducing deaths from some conditions, while other conditions have seen only moderate change or even little or no change. Gaps remain, both in research areas and in the application of results to benefit women in general and across multiple population groups. Given the many and significant roles women play in our society, maintaining support for women's health research and enhancing its impact are not only in the interest of women, they are in the interest of us all.