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Institute of Medicine (US) Committee on Women's Health Research. Women’s Health Research: Progress, Pitfalls, and Promise. Washington (DC): National Academies Press (US); 2010.
Women make up just over half the US population and should not be considered a special, minority population, but rather an equal gender whose health needs require equal research efforts as those for men. Historically, however, the health needs of women, apart from reproductive concerns, have lagged in medical research. In 1985, the Public Health Service Task Force on Women’s Health Issues concluded that “the historical lack of research focus on women’s health concerns has compromised the quality of health information available to women as well as the health care they receive.” Since the publication of that report, there has been a transformation in women’s health research—including changes in government support of research, in policies, in regulations, and in organization—that has resulted in the generation of new scientific knowledge about women’s health. Offices on women’s health have been established in a number of government agencies. 1 Government reports and reports from other organizations, including the Institute of Medicine (IOM), have highlighted the need for, and tracked the progress of, the inclusion of women in health research. A number of nongovernment organizations have also provided leadership in research in women’s health. And women as advocates, research subjects, researchers, clinicians, administrators, and US representatives and senators have played a major role in building a women’s health movement.
Given the research activities occurring in women’s health over the last 2 decades, in the Consolidated Appropriations Act of 2008 (Public Law 110-161) Congress provided the Department of Health and Human Services Office on Women’s Health (OWH) with funds for the IOM “to conduct a comprehensive review of the status of women’s health research, summarize what has been learned about how diseases specifically affect women, and report to the Congress on suggestions for the direction of future research.” In response, the OWH requested that the IOM conduct a study of women’s health research; the charge to the committee for the project is presented in Box S-1 .
Charge to the Committee. An Institute of Medicine committee will examine what the research on women’s health has revealed; how that research has been communicated to providers, women, the public and others; and identify gaps in those areas. The (more...)
In response to that request, the IOM convened a committee of 18 members who had a wide variety of expertise, including expertise in biomedical research, research translation, research communication, disabilities, epidemiology, healthcare services, behavioral and social determinants of health, health disparities, nutrition, public health, women’s health, clinical decision making, and such other medical specialties as cardiovascular disease (CVD), mental health, endocrinology, geriatrics, and immunology.
The committee met six times, including two open information-gathering sessions at which the members heard from stakeholders and researchers, and conducted extensive literature searches of publications from the last 15–20 years. The committee approached women’s health as a concept that has expanded beyond a narrow focus on the female reproductive system to encompass other conditions that create a significant burden in women’s lives. The committee focused on health conditions that are specific to women, are more common or more serious in women, have distinct causes or manifestations in women, have different outcomes or treatments in women, or have high morbidity or mortality in women. Numerous conditions could be included in such a list. The committee could not review all such conditions and, therefore, highlights a number of such conditions as examples that are specific to women; that have differences in prevalence, severity, preferred treatment, or understanding for women; or that the condition is prominent in women or there is a research need regarding women, whether or not there are sex-differences. Searches included research on factors that are determinants of health (biologic, psychologic, environmental, and sociocultural factors), especially factors that might affect women disproportionately or uniquely, and on the translation of research findings into practice and the communication of research findings to the public.
When considering health end points, the committee did not present a comprehensive review of findings of all research on all diseases, disorders, and conditions that are women’s health issues. The committee identified a number of conditions that have a large impact on women, reviewed the literature related to them, and categorized them as conditions in relation to which there has been major, some, or little improvement in women’s health.
The committee developed a series of questions to focus deliberations and ensure appropriate response to the charge. Those questions and the committee’s responses to them are presented below.
Determinants can range from a woman’s genetic makeup to her behaviors to the social, cultural, and environmental context in which genetic vulnerabilities and individual traits and behaviors are developed and expressed. Over the last 20 years, much has been learned about what the determinants of women’s health are.
The committee found that many behavioral determinants (such as smoking, eating habits, and lack of physical activity) are risk factors for most of the conditions under consideration. Those behavioral factors, in turn, are shaped by cultural, social, and societal contexts. Marked differences in the prevalence of and mortality from various conditions in women who experience social disadvantage due to race and ethnicity, lack of education, low income, and other factors have been documented. The differences stem from a variety of social determinants, including differential exposure to stressors and violence, which are more common in more disadvantaged communities. Such exposures are related to wide-ranging outcomes, including injury and trauma, depression, arthritis, asthma, heart disease, human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), and other sexually transmitted infections.
The underlying determinants of health and their relative power may differ by sex and gender, and tailored interventions might be more effective than generic treatments. As discussed in Chapter 2 , few studies have tested ways to modify behavioral determinants in women, and even less research has been conducted on the effects of social and community factors in specific groups of women.
The committee discussed the research of a number of conditions as examples of conditions that greatly affect women. It categorized those conditions as having major, some, or little progress (see Table S-1 ).
Conditions Discussed by Committee, Categorized by Extent of Progress.
The committee identified breast cancer, CVD, and cervical cancer as the conditions on which major progress has been made.
Mortality from breast cancer has decreased in the last 20 years. Consumer demand and involvement and increased funding have spurred breast-cancer research at the molecular, cellular, and animal levels as well as clinical trials and observational studies in women. That research has led to the development of more sensitive detection methods, biomarkers of risk and of more aggressive tumors, identification of risk factors, and treatment options that improve survival and posttreatment quality of life. The finding in the Women’s Health Initiative (WHI) of increased risk of breast cancer from hormone therapy led to changes in practice, and a substantial drop in the incidence of breast cancer has been attributed to those changes in practice. Progress has not been seen to the same extent in all groups of women, however; for example, black women have higher mortality from breast cancer than white women despite a lower incidence.
CVD is the leading cause of death of both women and men. As in men, age-adjusted mortality from coronary heart disease was reduced by half in women from 1980 to 2000. About half the decline is attributable to changes in behavioral factors, including a drop in smoking; the other half is attributable to new clinical treatments that emerged from research. Studies led to recognition of CVD in women and, subsequently, extension of diagnosis and treatments for CVD to women. Awareness of CVD among women has increased, in part because of educational campaigns. However, the history of years of the study of CVD only in men has delayed greater progress.
Reductions in the incidence of and mortality from cervical cancer began as early as the 1960s and continued over the last 20 years as diagnosis and screening have improved further. In addition, during the last few years a vaccine that is effective in preventing infection by human papillomavirus, the virus that causes most cervical cancer, was developed. The vaccine was developed and brought into clinical practice through research on the basic biology of the virus and its relationship to cervical cancer in human cells and animals and through epidemiologic studies of cervical cancer’s etiology. Although overall gains have been seen in mortality from cervical cancer, rates remain higher in black and Hispanic women than in white and Asian women.
The committee identified depression, HIV/AIDS, and osteoporosis as conditions on which some progress has been made as a result of women’s health research.
The incidence and consequences (such as effects on educational attainment) of depression are higher in women than in men. Advances have been made in the treatment of depression in the last 20 years, although their impact has not been maximized, because of inadequate translation particularly in relation to primary providers. There have been rapid and major advances in the treatment of HIV/AIDS in the last 20 years, mostly through research in men. The rapid development of treatments has benefited women despite the focus of the research on men; however, the predominance of male-focused studies has limited some of the benefits for women. For example, issues with the toxicity of HIV/AIDS treatments in women (for example, increased risk of anemia and acute pancreatitis as compared to men) are only now being identified through women-based research. Over the last 20 years there have been advances in the knowledge of the basic science underlying osteoporosis and in the diagnosis and treatment of osteoporosis. That includes the identification of genes whose expression affects the risk of osteoporosis. Recent trends show a decrease in the incidence of hip factures. Osteoporosis remains, however, a condition that greatly impacts the quality of life of a large number of women, particularly as they age.
The committee identified a number of conditions on which little progress has been made in reducing incidence or mortality, including unintended pregnancy 2 and autoimmune disease. The risk factors for unintended pregnancy are known, and effective contraceptives are available to prevent pregnancy. The fact that unintended pregnancies continue to occur at a high rate points to the need for research on the use of contraceptive regimens, the need for development of new contraceptives, including non-hormonal contraceptives, that are more acceptable to groups of women in which unintended pregnancies occur with greater frequency, and the need for social and community-level interventions to decrease unintended pregnancies. Autoimmune diseases constitute about 50 diseases, most of which are more common in women. As a group, they are the leading cause of morbidity in women, and they affect women’s quality of life greatly. Despite their prevalence and morbidity, little progress has been made toward a better understanding of those conditions, identifying risk factors, or developing a cure.
Looking at the set of conditions on which little progress has been made—including unintended pregnancy; autoimmune disease; alcohol-addiction and drug-addiction disorders; lung, ovarian, endometrial, and colorectal cancer; non-malignant gynecologic disorders; and Alzheimer’s disease—the committee tried to identify characteristics or explanations for the lack of progress. The committee could not determine specifically why progress was seen for some conditions and not others, but it considered a number of potential reasons, including degree of attention and subsequent research funding from government agencies, consumer advocacy groups, and Congress; availability of interested researchers trained in a given field; adequacy of understanding of the underlying pathophysiology of a condition; availability of sensitive and specific diagnostic tests and screening programs to identify persons who are at risk for or who have a condition; morbidity, rather than mortality, as the outcome of a disease; and barriers associated with political or social concerns.
Many of the conditions that the committee reviewed are more common or have poorer outcomes in women who are socially disadvantaged than in women who are not. They include the three diseases on which there has been major progress—breast cancer, CVD, and cervical cancer. The fact that subgroups of women are not benefiting from the progress that has been made could indicate that the most relevant groups, the groups that have the greatest burden of disease, are not being adequately studied and research results are not being translated into practice and policies.
The women’s health research reviewed includes basic research (studies in animals and at the molecular and cellular levels), epidemiologic or clinical research (research conducted or observed in human subjects), and studies of health systems. All those study types have contributed to progress in women’s health, and all yielded important findings on the conditions on which there has been major progress—breast cancer, CVD, and cervical cancer.
The committee identified a number of issues specific to the studies reviewed or to women’s health. Large observational studies—such as the observational arm of the WHI, the Nurses’ Health Study, and the Study of Women’s Health Across the Nation (SWAN)—were coordinated among multiple research centers to accrue large and diverse samples and were especially useful for generating hypotheses for further testing. The postmenopausal hormone therapy and the calcium and vitamin D components of the WHI were randomized clinical trials that were based on the findings from such observational research. In addition, the observational studies led to animal and in vitro studies aimed at elucidating the pathophysiology of conditions and identifying potential treatments.
Different study types have different limits, and results from diverse study designs can combine to provide extremely useful information that is directly relevant to the health of women and some have led to clear improvements in women’s health. The committee recognizes that there are drawbacks to different study types. For example, observational studies and clinical trials can be expensive, can have subject attrition, can be of long duration, and, in the case of observational studies, can have difficulty in finding appropriate comparison populations and in controlling for potential confounders. Large human studies, such as the WHI, are further hindered by complex study designs and associated pitfalls. Despite those drawbacks, the committee concluded that information from large, complex observational and clinical studies could not be obtained with other study designs and are integral to progress in women’s health. New study designs that yield similar levels of certainty would be valuable. Smaller studies, in contrast, provide different information and can often be better controlled, potentially faster (depending on the end points studied), and less expensive. Internal validity (for example, the ability to establish causal relationships) is generally stronger in such studies, but this may be at the cost of external validity (that is, generalizability). Smaller studies are important to provide information on which to base large studies and to test specific hypotheses.
Although women are now routinely included in clinical research, the initial design often is not optimal for obtaining data on women, including problems in the inclusion criteria and selection of end points that do not apply to women. Sample size and the ability to recruit adequate numbers of women in studies to allow appropriate analyses can be challenging. Sex- and gender-specific analyses must be published and used for drug development or clinical guidelines. Even when sex-specific analyses are conducted by researchers, the analyses are not always included in publications, because of page limitations or journal restrictions.
Studies often use incidence and 5-year survival rates as end points; fewer studies look at morbidity or quality of life after treatment and survival. Given that women tend to report worse overall health than do men and tend to emphasize quality of life when considering their health, the lack of assessment of quality of life in studies of women’s health is problematic.
It can take 15–20 years for research findings to be incorporated into practice. Barriers to translation of findings on women’s health include barriers that impede translation of science to practice more generally, such as the iterative nature of research in which inconsistent or contradictory results often are published before a clear picture emerges; social and cultural opposition to some new treatments or approaches; entrenched financial or other interests that favor the status quo or a specific approach; and lack of reimbursement for new treatments or practices. Patients themselves faced with a multitude of research findings and complex decisions can have difficulty in weighing new options for their health.
Other barriers, however, differentially affect the translation of research into better care for women. They are derived from the fragmentation of care that results when women see multiple providers for different health concerns, failure of performance measures to include many conditions that are specific to women, and failure to analyze sex-based differences in care, which undermines the use of incentives to implement research findings in women’s health care.
Complex and sometimes inconsistent or contradictory results present challenges to the communication of research findings, including those relevant to women. Often, the implications of a given finding are complex, so it is difficult to give a clear, concise message. The emergence of the Internet and the World Wide Web has increased the amount of and access to health-related information for the general public, but it has also added to the confusion about the findings and to concerns about the validity of the available information. Communication is complicated by competing forces, for example, when health messages compete with the marketing forces of industries.
Relatively few studies have been published on a number of conditions important to women, including ovarian and endometrial cancer, pre-eclampsia (a major cause of maternal morbidity and mortality), and conditions that affect elderly women, including frailty. There is little information on many autoimmune diseases, such as lupus. Research on prevention of and treatment for Alzheimer’s disease, obesity, and diabetes has rarely examined sex differences. Despite the prevalence of co-occurring conditions and the need to evaluate risk–benefit tradeoffs across multiple outcomes, such issues are rarely incorporated into studies of specific conditions. More information on how the physical and social environment affect health is needed, including an understanding of how they may result in health disparities in disadvantaged groups. In some cases, particularly reproductive health, strong data supporting the safety and efficacy of treatments may be insufficient to fuel their use if there is social or political opposition on nonmedical grounds. Advances in women’s health may require attention to such obstacles in addition to those inherent in the research.
Substantial progress has been made since the expansion of investment in women’s health research. Research findings have changed the practice of medicine and public-health recommendations in several prominent contexts, including changes in standards of care for women. There have also been decreases in mortality in women from breast cancer, heart disease, and cervical cancer. In other contexts, however, there has been less progress, including research on other conditions that affect women and identification of ways to reduce disparities among subpopulations of women.
Several barriers to further progress in improving the health status of women were identified. For example, there has been inadequate attention to the social and environmental factors that, along with biologic risk factors, influence health. There also has been inadequate enforcement of requirements that representative numbers of women be included in clinical trials and that women’s results be reported. A lack of taking account of sex and gender differences in the design and analysis of studies, and a lack of reporting on sex and gender differences, has hindered identification of potentially important sex differences and slowed progress in women’s health research and its translation to clinical practice. The committee recommends that all published scientific reports that receive federal funding and all medical product evaluations by the Food and Drug Administration present efficacy and safety data separately for men and women.
Poor communication of the results of women’s health research has in many cases led to substantial confusion and may affect the care of women adversely. Research findings will have a greater impact if they are coupled with a well thought-out plan for communication and dissemination. Development of a plan for communication and dissemination should be a standard component of federally sponsored women’s health research and the clinical recommendations that are made on the basis of that research.
The committee’s specific findings and recommendations follow.
Investment in women’s health research has afforded substantial progress and led to improvements in women’s health with respect to such important conditions as some cancers and heart disease. Greater progress in women’s health has occurred in conditions characterized by multipronged research involving molecular, animal, and cellular data; in observational studies to identify effects in the overall population; and in clinical trials or intervention studies from which evidence-based conclusions on treatment effectiveness can be drawn.
Recommendation 1
US government agencies and other relevant organizations should sustain and strengthen their focus on women’s health, including the spectrum of research that includes genetic, behavioral, and social determinants of health and how they change during one’s life. In addition to conducting women-only research as appropriate, a goal should be to integrate women’s health research into all health research—that is, to mainstream women’s health research—in such a way that differences between men and women and differences between subgroups of men and women are routinely assessed in all health research. Relevant US government agencies include the Department of Health and Human Services and its institutes and agencies—especially the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Agency for Healthcare Research and Quality, and the Substance Abuse and Mental Health Services Administration—and such others as the Department of Veterans Affairs, the Department of Defense, and the Environmental Protection Agency.
Women who experience social disadvantage as a result of race or ethnicity, low income, or low educational level suffer disproportionate disease burdens, adverse health outcomes, and barriers to care but have not been well represented in studies of behavior and health.
Recommendation 2
The National Institutes of Health, the Agency for Healthcare Research and Quality, and the Centers for Disease Control and Prevention should develop targeted initiatives to increase research on the populations of women that have the highest risks and burdens of disease.
The incidence, prevalence, morbidity, or mortality associated with a number of conditions—for example, unintended pregnancy, maternal mortality and morbidity, nonmalignant gynecologic disorders, alcohol- and drug-addiction disorders, autoimmune diseases, and lung, ovarian, and endometrial cancer—have not improved. Most of those conditions substantially affect the quality of life of those who experience them. The major focus of health research has been on reducing mortality; a singular focus on mortality, however, can divert attention from other health outcomes despite the high value that women place on quality of life.
Recommendation 3
Research should include the promotion of wellness and quality of life in women. Research on conditions that have high morbidity and affect quality of life should be increased. Research should include the development of better measures or metrics to compare effects of health conditions, interventions, and treatments on quality of life. The end points examined in studies should include quality-of-life outcomes (for example, functional status or functionality, mobility, and pain) in addition to mortality.
Social factors and health-related behaviors and their interactions with genetic and cellular factors contribute to the onset and progression of multiple diseases; they act as pathways that are common to multiple outcomes. Considerable progress has been made in understanding the behavioral determinants of women’s health, but less is known about how to change them and about the broader determinants of women’s health that involve social, community, and societal factors.
Recommendation 4
Cross-institute initiatives in the National Institutes of Health—such as those in the Division of Program Coordination, Planning, and Strategic Initiatives—should support research on common determinants and risk factors that underlie multiple diseases and on interventions on those determinants that will decrease the occurrence or progression of diseases in women. The National Institutes of Health’s Office of Research on Women’s Health should increase collaborations with the Office of Behavioral and Social Sciences Research to design and oversee such research initiatives.
Limitations in the design, analysis, and scientific reporting of health research have slowed progress in women’s health. Inadequate enforcement of recruitment of women and of reporting data by sex has fostered suboptimal analysis and reporting of data on women from clinical trials and other research. That failure has limited possibilities for identifying potentially important sex or gender differences. New methods and approaches are needed to maximize advances in promoting women’s health.
Recommendation 5
The translation of research findings into practice can be delayed or precluded by various barriers—the complexity of science and research and challenges in communicating understandable and actionable messages, social or political opposition to advances for nonmedical reasons, fragmentation of health-care delivery, health-care policies and reimbursement, consumer confusion and apprehension, and so on. Many of those barriers are seen in connection with translation of research in general, but some have aspects that are peculiar to women, and few studies have been conducted to examine how to increase the speed or extent of the translation of findings related specifically to women’s health into clinical practice. Methods of translation that have been used and that warrant evaluation for translating research findings in women include clinical-practice guidelines, mandatory standards, reimbursement practices, laws (including public-health laws), health-professions school curricula, and continuing education.
Recommendation 6
Research should be conducted on how to translate research findings on women’s health into clinical practice and public-health policies rapidly. Research findings should be incorporated at the practitioner level and at the overall public-health systems level through, for example, the use of education programs targeted to practitioners and the development of guidelines. As programs and guidelines are developed and implemented, they should be evaluated to ensure effectiveness.
The public is confused by conflicting findings and opposing recommendations that emerge from health research, including women’s health research. Conflicting results and work to resolve disagreements are part of the scientific process, but that iterative aspect of scientific discovery is not clearly conveyed to, or understood by, the public. The resulting uncertainty and distrust of research may affect women’s care adversely. Relevant knowledge from studies of communication often is not used by researchers, funders, providers, and public-health professionals to target health messages and information to women.
Recommendation 7
The Department of Health and Human Services should appoint a task force to develop evidence-based strategies to communicate and market health messages that are based on research results to women. In addition to content experts in relevant departments and agencies, the task force should include mass-media and targeted-messaging and marketing experts. The strategies should be designed to communicate to the diverse audience of women; to increase awareness of women’s health issues and treatments, including preventive and intervention strategies; and to decrease confusion regarding complex and sometimes conflicting findings. The goals of the task force should be to facilitate and improve the communication of research findings by researchers to women. Strategies for the task force to consider or explore might include
During the preparation of this report the Patient Protection and Affordable Care Act of 2010 (Public Law 111-148) was passed, which formally codifies the Offices of Women’s Health within the Department of Health and Human Services (HHS). The act also formally establishes an Office of Women’s Health in the directors’ office of the Agency for Healthcare Research and Quality, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Health Resources and Services Administration, the Substance Abuse and Mental Health Services Administration; an HHS Coordinating Committee on Women’s Health; and the National Women’s Health Information Center.
The committee considered whether to discuss unintended pregnancy as a health outcome or a determinant of health. It decided to discuss it as an outcome, along with maternal mortality and morbidity, and also to discuss the determinants that increase the rate of unintended pregnancies in Chapter 2 .
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