Addressing the Public Health Crisis of Maternal Mortality: A National Research Agenda.

This Viewpoint discusses the National Institutes of Health initiative that focuses on research that reduces preventable maternal mortality, decreases severe maternal morbidity, and promotes health equity.

The roles of sex and gender in women's eye health disparities in the United States.

BACKGROUND: In the United States, women are at a higher risk of developing vision impairment or a serious eye disease (such as age-related macular degeneration, thyroid eye disease, or chronic dry eye disease) than men. Disparities in eye diseases due to biology widen even further when considering factors such as social determinants of health; gaps in research data, literature, and policy; insufficient provider and patient education; and limitations in screening and treatment options. Sex and gender disparities in eye health are clinically under-addressed and burdensome on both patient quality of life and the health care and economic systems, resulting in a pressing population health issue that negatively impacts women. DESIGN: The Society for Women's Health Research convened a working group of expert clinicians, researchers, and patient advocates to review the current state of science regarding sex and gender disparities in women's eye health, identify knowledge gaps and unmet needs, and explore better means to advance research, improve patient care, and raise awareness of key issues. DISCUSSION: The SWHR Women's Eye Health Working Group identified priority areas in research, clinical care, and education to reduce disparities and improve patient care in women's eye health. The working group recommends using a systems approach that incorporates a comprehensive research framework with a sex and gender lens to guide future work and that increases health care provider and public education, as well as engagement by expanding partnerships among ophthalmologic providers, researchers, and non-vision stakeholders.

The Integration of Sex and Gender Considerations Into Biomedical Research: Lessons From International Funding Agencies.

To improve the outcomes of research and medicine, government-based international research funding agencies have implemented various types of policies and mechanisms with respect to sex as a biological variable and gender as a sociocultural factor. After the 1990s, the US National Institutes of Health (NIH), the Canadian Institutes of Health Research (CIHR), and the European Commission (EC) began requesting that applicants address sex and gender considerations in grant proposals, and offering resources to help the scientific community integrate sex and gender into biomedical research. Although it is too early to analyze data on the success of all of the policies and mechanisms implemented, here we review the use both of carrots (incentives) and sticks (requirements) developed to motivate researchers and the entire scientific research enterprise to consider sex and gender influences on health and in science. The NIH focused on sex as a biological variable (SABV) aligned with an initiative to enhance reproducibility through rigor and transparency; CIHR instituted a sex- and gender-based analysis (SGBA) policy; and the EC required the integration of the "gender dimension," which incorporates sex, gender, and intersectional analysis into research and innovation. Other global efforts are briefly summarized. Although we are still learning what works, we share lessons learned to improve the integration of sex and gender considerations into research. In conjunction with refining and expanding the policies of funding agencies and mechanisms, private funders/philanthropic groups, editors of peer-reviewed journals, academic institutions, professional organizations, ethics boards, health care systems, and industry also need to make concerted efforts to integrate sex and gender into research, and we all must bridge across silos to promote systemwide solutions throughout the biomedical enterprise. For example, policies that encourage researchers to disaggregate data by sex and gender, the development of tools to better measure gender effects, or policies similar to SABV and/or SGBA adopted by private funders would accelerate progress. Uptake, accountability for, and a critical appraisal of sex and gender throughout the biomedical enterprise will be crucial to achieving the goal of relevant, reproducible, replicable, and responsible science that will lead to better evidence-based, personalized care for all, but especially for women.

Pregnant in the United States in the COVID-19 pandemic: A collision of crises we cannot ignore.

NO abstract intended, Introduction is listed here The COVID-19 pandemic and call for social justice is occurring when the United States, unlike its peer countries, has already experienced a steady 20-year rise in maternal morbidity and mortality with pregnant women today facing a 50 percent higher risk of mortality than their mothers. 1 Most vulnerable are women of color, black and American Indian/Alaska Native women, who have experienced longstanding disparities in access to and quality of healthcare and may begin pregnancy with hypertension, diabetes, and obesity, complications known to be more common in women enduring segregation. 2-4 Initially, the race-related health disparities and resultant disproportionately higher rates of COVID-19 cases and mortality in indigenous communities and black, latinx, or other communities of color were mistakenly considered innate racial differences. More recently, these higher rates have been attributed to underlying social, structural, and environmental determinants of health including resource inequities, inadequate housing, and occupational and environmental hazards that result in greater exposure to and less protection from COVID-19. 5,6 Augmented by the added physiologic stress of pregnancy, these comorbidities and disparities compound the risk of pregnancy-associated cardiomyopathy, thromboembolism, and hemorrhage, often resulting in lasting physical and mental health consequences.

A review of the atomoRapid HIV self-testing device: an acceptable and easy alternative to facilitate HIV testing.

Introduction:HIV testing is the gateway to both HIV prevention and treatment, and increased HIV testing and linkage to services is vital for an effective HIV response. HIV testing has progressed significantly from a lengthy laboratory process conducted by specialist medical staff to rapid point of care testing performed by trained lay staff. Despite HIV testing services being widely available, testing rates remain suboptimal among young people and men. Alternative delivery strategies that complement conventional testing services are needed to reach these priority groups. Areas covered:This article reviewed the AtomoRapid HIV self-testing (HIVST) device as an innovative alternative to conventional testing. Expert commentary:HIVST complements traditional HIV testing options and can be used to overcome major barriers to testing by catering for testing outside of conventional settings and by allowing individuals to test themselves privately, and at their own discretion and frequency. We conclude that the high sensitivity, specificity, acceptability, usability, and fidelity of this device makes it an appropriate option for the enhancement of HIV testing strategies for harder to reach populations, such as young people and men.

Working Together to Address Women's Health in Research and Drug Development: Summary of the 2017 Women's Health Congress Preconference Symposium.

Historically, women have been underrepresented in clinical research, requiring physicians to extrapolate medical recommendations for women from clinical research done in cohorts consisting predominantly of male participants. While government-funded clinical research has achieved gender parity in phase-3 clinical trials across many biomedical disciplines, improvements are still needed in several facets of women's health research, such as the inclusion of women in early-phase clinical trials, the inclusion of pregnant women and women with physical and intellectual disabilities, the consideration of sex as a biological variable in preclinical research, and the analysis and reporting of sex and gender differences across the full biomedical research continuum. The National Institutes of Health (NIH) Office of Research on Women's Health and the Office of Women's Health of the U.S. Food and Drug Administration (FDA) cosponsored a preconference symposium at the 25th Annual Women's Health Congress, held in Arlington, VA in April, 2017, to highlight gains made and remaining needs regarding the representation of women in clinical research, to introduce innovative procedures and technologies, and to outline revised policy for future studies. Six speakers presented information on a range of subjects related to the representation of women in clinical research and federal initiatives to advance precision medicine. Topics included the following: the return on investment from the NIH-funded Women's Health Initiative; progress in including women in clinical trials for FDA-approved drugs and products; the importance of clinical trials in pregnant women; FDA initiatives to report drug safety during pregnancy; the NIH-funded All of Us Research Program; and efforts to enhance FDA transparency and communications, including the introduction of Drug Trials Snapshots. This article summarizes the major points of the presentations and the discussions that followed.

Reversing the Trends toward Shorter Lives and Poorer Health for U.S. Women: A Call for Innovative Interdisciplinary Research.

The United States (U.S.) is a leader and innovator in biomedicine, yet trails behind for many key health indicators, especially for women. This paper highlights key evidence indicating that not only is the state of women's health in the U.S. lagging, but it is at risk for falling off the curve. Women's health care remains fragmented; research in the field can be disconnected and difficult to integrate across disciplines-silos prevail. Structural obstacles contribute to this lack of cohesion, and innovative, interdisciplinary research approaches which integrate the multidimensional aspects of sex and gender, and race and ethnicity, with a life course perspective are sorely needed. Such synergistic, scientific strategies have the potential to reverse the trend towards shorter life expectancy and poorer health for women in the U.S. The National Institute for Health (NIH) seeks to raise the bar for the health of all women by tackling these issues through enhancing the relevance of biomedical research to the health of women and driving the sustained advancement of women in biomedical careers.

A Report of the 24th Annual Congress on Women's Health-Workshop on Transforming Women's Health: From Research to Practice.

Sex and gender are critical contributors to overall health and disease, and considering both in research informs the development of prevention strategies and treatment interventions for both men and women. The National Institutes of Health (NIH) Office of Research on Women's Health sponsored a preconference workshop on this topic at the 24th Annual Women's Health Congress, which was held in Crystal City, VA, in April 2016. The workshop featured presentations by NIH intramural and extramural scientists who presented data on a variety of topics including polycystic kidney disease, vaccine protection, depression, drug addiction, and cardiovascular disease. In this publication, we discuss the major points of each presentation and demonstrate the importance of considering sex and gender in biomedical research.

Women's Careers in Biomedical Sciences: Implications for the Economy, Scientific Discovery, and Women's Health.

While women have been well represented in medical school and biomedical doctoral degree programs, they do not comprise half of academic medicine faculty positions. Furthermore, there is a significant paucity of women in academic medicine leadership positions, as evidenced by the fact that only 16% of dean positions at United States Medical schools are filled by women. In this commentary, the authors review the state of women in academic medicine and argue that increased representation of women in the academic workforce will lead to economic gains, increased scientific discovery, and improvements to women's health.

A Report of the Women's Health Congress Workshop on The Health of Women of Color: A Critical Intersection at the Corner of Sex/Gender and Race/Ethnicity.

Women of color face unique health challenges that differ significantly from those of other women and men of color. To bring these issues to light, the National Institutes of Health (NIH) Office of Research on Women's Health sponsored a preconference workshop at the 23rd Annual Women's Health Congress, which was held in Washington, DC, in April 2015. The workshop featured presentations by NIH intramural and extramural scientists who provided insight on the disparities of a wide range of conditions, including cancer, cardiovascular disease, the risk of HIV infection, and disability in an aging population. In this study, we highlight the major points of each presentation and the ensuing discussion.

Racial and ethnic health disparities in reproductive medicine: an evidence-based overview.

Racial and ethnic health disparities in reproductive medicine exist across the life span and are costly and burdensome to our healthcare system. Reduction and ultimate elimination of health disparities is a priority of the National Institutes of Health who requires reporting of race and ethnicity for all clinical research it supports. Given the increasing rates of admixture in our population, the definition and subsequent genetic significance of self-reported race and ethnicity used in health disparity research is not straightforward. Some groups have advocated using self-reported ancestry or carefully selected single-nucleotide polymorphisms, also known as ancestry informative markers, to sort individuals into populations. Despite the limitations in our current definitions of race and ethnicity in research, there are several clear examples of health inequalities in reproductive medicine extending from puberty and infertility to obstetric outcomes. We acknowledge that socioeconomic status, education, insurance status, and overall access to care likely contribute to the differences, but these factors do not fully explain the disparities. Epigenetics may provide the biologic link between these environmental factors and the transgenerational disparities that are observed. We propose an integrated view of health disparities across the life span and generations focusing on the metabolic aspects of fetal programming and the effects of environmental exposures. Interventions aimed at improving nutrition and minimizing adverse environmental exposures may act synergistically to reverse the effects of these epigenetic marks and improve the outcome of our future generations.

Enrolling pregnant women: issues in clinical research.

BACKGROUND: Despite the fact that many pregnant women are affected by a range of serious health conditions and take medications for these conditions, there is widespread reticence to include them in clinical intervention research. Hence, their clinical care is typically not informed by evidence derived from pregnant populations. METHOD: In October 2010, the National Institutes of Health Office of Research on Women's Health convened a workshop to address ethical, regulatory, and scientific issues raised by the enrollment of pregnant women in clinical research. This report summarizes three areas that emerged from that meeting as important next steps to be taken to promote ethically responsible and scientifically sound research during pregnancy. FINDINGS: The three areas are: 1) Reclassify pregnant women from their current status in regulations as a "vulnerable" population to a scientifically "complex" population and change the presumption of exclusion to one of inclusion; 2) examine the institutional review boards' (IRB) gatekeeper role in interpreting regulations governing pregnancy research and identify steps to facilitate IRB approval of ethically informed pregnancy research; and 3) develop a pregnancy-focused research agenda that addresses pressing clinical needs, identifies opportunities to gather information from existing resources and studies, and encourages important new research areas. CONCLUSION: Research is needed to address the therapeutic needs of pregnant women and to study pregnancy as it may shed light on a pregnant woman's later health and the health of her child.

Monitoring the implementation of the national institutes of Health Strategic Plan for Women's Health and Sex/gender Differences research: Strategies and Successes.

Building upon the legacy of the previous two National Institutes of Health (NIH) women's health research agenda-setting reports,(1) (,) (2) the Office of Research on Women's Health (ORWH) released the third NIH scientific agenda for women's health and sex differences research in September 2010, entitled Moving Into The Future With New Dimensions and Strategies: A Vision for 2020 For Women's Health Research.(3) Within NIH, ORWH is part of the Division of Program Coordination, Planning, and Strategic Initiatives, residing in the Office of the Director; ORWH is charged with coordinating women's health research in collaboration with the 27 Institutes and Centers (ICs) that make up NIH, each of which has a distinct mission and identity. Of note, the 2010 research agenda, or strategic plan, is the women's health research agenda for NIH overall, cutting across the missions of all the ICs. As such, it serves as a map to guide new efforts as well as continue collaborations within NIH in order to fulfill the NIH mission to seek fundamental knowledge about the nature and behavior of living systems and to apply that knowledge to enhance health, lengthen life, and reduce illness and disability. Through the framework of the strategic plan, in partnership with the NIH ICs, the Office of the Director, and the Advisory Committees (Figure 1), ORWH leads efforts to meet this mission as it relates to women's health.

Surveillance of disparities in vision and eye health in the United States: an expert panel's opinions.

PURPOSE: To define surveillance approaches and metrics to capture the burden of vision health disparities and to identify properties of a surveillance system to guide public health interventions. DESIGN: Expert panel. METHODS: Analysis of relevant literature and deliberations of expert panel. RESULTS: The panel identified that the purpose of vision surveillance was to link data to public health interventions. Panel members noted the importance of assessing vision through self-reported and performance-based measures. Defined populations should be included in a surveillance system to assess disparities in utilization of eye care and vision loss. The panel suggested that ophthalmic/vision measures should be sustained in national surveys and suggested that a vision surveillance system should be forged among federal agencies. CONCLUSIONS: Employing the 6 outlined strategies would improve vision surveillance and help reach the vision-related objectives of Healthy People 2020.