Office Of Research On Women's Health Research Articles

Workshop summary: National Institutes of Health (NIH) 2022 scientific workshop on gender and health

In this manuscript, we summarize the goals, content, and impact of the Gender and Health: Impacts of Structural Sexism, Gender Norms, Relational Power Dynamics, and Gender Inequities workshop held by the National Institutes of Health (NIH) Office of Research on Women's Health (ORWH) in collaboration with 10 NIH Institutes, Centers, and Offices. Specifically, we outline the key points emerging from the workshop presentations, which are the focus of the collection of articles in this supplement. The overarching goals of the workshop were to convene NIH staff, the external scientific community, and the public to discuss methods, measurement, modifiable factors, interventions, and best practices in health research on gender as a social and cultural variable and to identify opportunities to advance research and foster collaborations on these key topics. Themes emerging from the workshop include the need for intersectional measures in research on gender and health, the role of multilevel interventions and analyses, and the importance of considering gender as a social and structural determinant of health. Careful, nuanced, and rigorous integration of gender in health research can contribute to knowledge about and interventions to change the social and structural forces that lead to disparate health outcomes and perpetuate inequities.

Putting science to work for women's health.

The Office of Research on Women's Health (ORWH)'s whole health paradigm expands the scope of women's health research, incorporating a life-course perspective that recognizes the profound influences of sex and gender on health. From childhood through adulthood, external and societal factors along with internal factors and biology shape women's health and influence access to quality healthcare. This comprehensive approach integrates data-driven sex- and gender-aware strategies to prevent, diagnose, and treat disease, focusing on the unique needs of women. Acknowledging the historical lack of timely research and data on women's health, an initiative led by First Lady Dr. Jill Biden and the White House Gender Policy Council, ushers in a new era of women's health research that offers unprecedented opportunities to enhance the health of women through biomedical and behavioral research. The initiative fosters interdisciplinary collaboration, supporting research on autoimmune diseases, menopause, oral health, and chronic pain conditions. ORWH serves as the focal point for National Institutes of Health (NIH) women's health research. With a commitment to advancing holistic outcomes, ORWH engages in partnerships, outreach, and educational initiatives to disseminate critical research findings and support women's health researchers. Here we describe the convergence of this initiative with the National Institute of Dental and Craniofacial Research's work to advance the understanding of sex as a biological variable for conditions such as Sjogren's disease and temporomandibular disorder. This transformative approach to women's health research propels the United States toward innovative solutions, ensuring that science works for the health and well-being of every woman.

Developing Researchers with Expertise in Sex as a Biological Variable through SCORE Career Enhancement Core Center Programs.

There is a critical need for interdisciplinary and translational scientists to apply sex as a biological variable (SABV) research to address knowledge gaps in the health of women. In 2018, the Office of Research on Women's Health (ORWH) partnered with several National Institute of Health (NIH) Institutes and Centers to expand the Specialized Centers of Research (SCOR) Excellence (SCORE) Programs (together referred to as SCOR/E) with an important feature-the Career Enhancement Core (CEC). The SCORE CEC mentors early career investigators to become the next generation of biomedical and behavioral researchers focused on SABV and women's health. In this article, we outline our approach at the Yale University SCORE to support early career trajectories through the provision of salary support, educational curricula, translational mentorship, pilot project funding, and professional development. Using the Yale-SCOR/E CEC Programs as instructional models, we highlight critical measures of academic success, namely grant funding and publications, among early career investigators. At Yale University, 12 pilot projects funded by the SCOR/E Programs resulted in 14 extramural grants, amounting to an $80 return on every $1 invested in "seed" funding. So far, our SCOR/E Programs have resulted in 129 publications, 83% of which were first-authored by trainees, and 100% of trainees continued research careers with an emphasis on SABV. Finally, we provide recommendations on how biomedical scientists can apply SABV in their studies of major medical conditions in an interdisciplinary and integrative way.

Establishment of a Private Foundation-Academic Partnership to Promote Careers of Early-Stage Investigators Examining the Influence of Sex and Gender on Health and Health Care.

Biological sex and gender-based constructs contribute significantly to the diversity of disease outcomes and treatment responses across the life course. To promote research considering sex and gender, the National Institutes of Health (NIH) Office of Research on Women's Health (ORWH) launched the Specialized Centers of Research Excellence (SCORE) on sex differences program. The Career Enhancement Core (CEC) of the Johns Hopkins SCORE on Sex and Age Differences in Immunity to Influenza (SADII) partnered with the Foundation for Gender-Specific Medicine, which matched NIH funding to support seed grants. Over 3 years we awarded 12 (10 were women faculty) seed grants to early-stage investigators. One year after the award, the seed grant awardees highlighted their progress, including publications, grant applications, and abstracts. All awardees noted challenges with their progress related to the COVID-19 pandemic and supply chain delays and shared suggestions for improving the programming of the CEC. They also highlighted the multiple ways the awards had helped them gain pilot data toward larger grants, build collaborative relationships, and present at the annual SCORE symposium. We describe a model and evidence supporting a private-academic collaboration to support the careers of early-stage investigators conducting research related to sex and gender.

Public Priorities in Women's Health: Analysis of Request for Information Published to Inform "Advancing NIH Research on the Health of Women: A 2021 Conference".

Objectives: To assist with planning a congressionally requested conference on women's health research, the National Institutes of Health (NIH) Office of Research on Women's Health (ORWH) invited comments to characterize public concerns related to any or all of the specified public health issues: maternal morbidity and mortality (MMM); stagnant rates of cervical cancer survival; and the growing incidence of chronic debilitating conditions in women (CDCW). This analysis summarizes public priorities in women's health research. Materials and Methods: All comments received in response to a request for information were open coded and a master list of keywords was created, and comments were categorized. Comments addressing CDCW were categorized using a conceptual framework developed by the NIH. Results: Two hundred forty-seven comments were coded and analyzed. One hundred four comments (42%) addressed MMM; 182 comments (73%) discussed CDCW; and 27 comments (10%) addressed cervical cancer. Comments focused on CDCW most frequently addressed female-specific conditions (83%). The 10 most frequently identified keywords in order of frequency from the manual coding were as follows: (1) MMM, (2) racial disparities, (3) access to care, (4) provider training, (5) mental health, (6) Black or African American women, (7) screening, (8) quality of care, (9) time to diagnosis, and (10) social determinants of health. Conclusions: Comments demonstrate a broad range of concerns related to the health of women, including MMM, CDCW, and cervical cancer. A wide array of commenters included patients, advocacy groups, and academic and professional organizations originating from geographically diverse locations. These comments reflect a strong desire from the public to prioritize research on the health of women.

Longitudinal associations of insulin resistance with change in bone mineral density in midlife women.

BACKGROUNDThe effects of insulin resistance on bone mineral density (BMD) are unclear.METHODSIn Study of Women's Health Across the Nation (SWAN) participants, we used multivariable regression to test average insulin resistance (homeostatic model assessment of insulin resistance, HOMA-IR) and rate of change in insulin resistance as predictors of rate of change in lumbar spine (LS) and femoral neck (FN) BMD in 3 stages: premenopause (n = 861), menopause transition (MT) (n = 571), and postmenopause (n = 693). Models controlled for age, average BW, change in BW, cigarette use, race and ethnicity, and study site.RESULTSThe relation between HOMA-IR and BMD decline was biphasic. When average log2HOMA-IR was less than 1.5, greater HOMA-IR was associated with slower BMD decline; i.e., each doubling of average HOMA-IR in premenopause was associated with a 0.0032 (P = 0.01, LS) and 0.0041 (P = 0.004, FN) g/cm2 per year slower BMD loss. When greater than or equal to 1.5, average log2HOMA-IR was not associated with BMD change. In women in whom HOMA-IR decreased in premenopause, the association between the HOMA-IR change rate and BMD change rate was positive; i.e, slower HOMA-IR decline was associated with slower BMD loss. In women in whom insulin resistance increased in premenopause, the association was negative; i.e, faster HOMA-IR rise was associated with faster BMD decline. Associations of average HOMA-IR and HOMA-IR change rate with BMD change rate were similar in postmenopause, but weaker during the MT.CONCLUSIONWhen it decreases, insulin resistance is associated with BMD preservation; when it increases, insulin resistance is associated with BMD loss.FUNDINGThe SWAN has grant support from the NIH of the Department of Health and Human Services (DHHS) through the NIH National Institute on Aging (NIA), National Institute of Nursing Research (NINR), and Office of Research on Women's Health (ORWH) (grants U01NR004061, U01AG012505, U01AG012535, U01AG012531, U01AG012539, U01AG012546, U01AG012553, U01AG012554, U01AG012495, and U19AG063720).

Abstracts from the NIH Office of Research on Women's Health 2022 Annual BIRCWH Meeting:Building Interdisciplinary Research Careers in Women's Health November 2, 2022

Abstracts from the NIH Office of Research on Women's Health 2022 Annual BIRCWH Meeting:Building Interdisciplinary Research Careers in Women's Health November 2, 2022

Impact of Sex and Gender on Autoimmune Lung Disease: Opportunities for Future Research: NHLBI Working Group Report.

Pulmonary complications are a leading cause of morbidity and mortality in patients with autoimmune disease. Substantial evidence suggests that biological sex (i.e., regulated by genes, hormonal profiles) and gender (i.e., a social construct based on environmental, cultural and behavioral factors and choices that affect a person's self-identity) uniquely affect fundamental molecular and cellular processes related to autoimmune lung disease pathogenesis. In addition, both sex and gender can influence disease susceptibility, clinical manifestations and response to therapy in patients with autoimmune lung disease. However, female mammals are usually excluded from basic science research, and clinical studies in this area often fail to explore the impact of sex/gender on outcomes. Recognizing the inherent value in the study of sex and gender differences in autoimmune lung diseases, the National Heart, Lung, and Blood Institute (NHLBI) partnered with the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the Office of Research on Women's Health (ORWH) to organize a two-day virtual sex- and gender-related autoimmune lung diseases (SG-RAILD) workshop in June 2021. The goals of the workshop were to discuss the influences of sex and gender on autoimmune lung diseases with a focus on novel experimental methods. Specifically, Workshop participants from diverse areas suggested innovative strategies for enhancing scientific rigor and facilitating new discovery in this area. The present Workshop report summarizes opportunities for future sex- and gender-informed preclinical and clinical research. The report also provides suggestions for training future scientists to carry this research forward.

Genome-wide association study meta-analysis identifies three novel loci for circulating anti-Müllerian hormone levels in women.

Genome-wide association study meta-analysis identifies three novel loci for circulating anti-Müllerian hormone levels in women.

Research on Women's Health: Ready for the Future.

The National Institutes of Health (NIH) Office of Research on Women's Health (ORWH) was established in 1990. With the completion of the office's 30th anniversary year, we look back and recount some of the key events and overall zeitgeist that led to ORWH's formation, and how it became the focal point at the nation's primary biomedical research agency for coordinating research on science to improve the health of women. We discuss ORWH's mission and signature programs and the bold vision that drives the NIH-wide strategic, interdisciplinary, and collaborative approach to research on women's health and efforts to promote women in biomedical careers. Also discussed are several of the many scientific advances in research on the health of women, policy innovations and their effects, and career advancements made by women in medicine and related scientific fields. We also highlight key challenges for the health of women, the need to continue pushing for equity in biomedical research careers, and NIH's approach to addressing these problems to ensure progress for the next 30 years and beyond.

Pregnancy and SARS-CoV-2: an opportunity to systematically study the complexity of maternal health

Pregnancy and SARS-CoV-2: an opportunity to systematically study the complexity of maternal health

The association of COVID-19 infection in pregnancy with preterm birth: A retrospective cohort study in California

Introduction: Our understanding of the association between coronavirus disease 19 (COVID-19) and preterm or early term birth among racially and ethnically diverse populations and people with chronic medical conditions is limited.Methods: We determined the association between COVID-19 and preterm (PTB) birth among live births documented by California Vital Statistics birth certificates between July 2020 and January 2021 (n=240,147). We used best obstetric estimate of gestational age to classify births as very preterm (VPTB, <32 weeks), PTB (< 37 weeks), early term (37 and 38 weeks), and term (39-44 weeks), as each confer independent risks to infant health and development. Separately, we calculated the joint effects of COVID-19 diagnosis, hypertension, diabetes, and obesity on PTB and VPTB.Findings: COVID-19 diagnoses on birth certificates increased for all racial/ethnic groups between July 2020 and January 2021 and were highest for American Indian/Alaska Native (12.9%), Native Hawaiian/Pacific Islander (11.4%), and Latinx (10.3%) birthing people. COVID-19 diagnosis was associated with an increased risk of VPTB (aRR 1.6, 95% CI [1.4, 1.9]), PTB (aRR 1.4, 95% CI [1.3, 1.4]), and early term birth (aRR 1.1, 95% CI [1.1, 1.2]). There was no effect modification of the overall association by race/ethnicity or insurance status. COVID-19 diagnosis was associated with elevated risk of PTB in people with hypertension, diabetes, and/or obesity.Interpretation: In a large population-based study, COVID-19 diagnosis increased the risk of VPTB, PTB, and early term birth, particularly among people with medical comorbidities. Considering increased circulation of COVID-19 variants, preventative measures, including vaccination, should be prioritized for birthing persons.Funding: UCSF-Kaiser Department of Research Building Interdisciplinary Research Careers in Women's Health Program (BIRCWH) National Institute of Child Health and Human Development (NICHD) and the Office of Research on Women's Health (ORWH) [K12 HD052163] and the California Preterm Birth Initiative, funded by Marc and Lynn Benioff.

Maternal Morbidity and Mortality.

Maternal Morbidity and Mortality.

Developing the Process and Tracking the Implementation and Evaluation of the National Institutes of Health Strategic Plan for Women's Health Research.

BackgroundThe National Institutes of Health (NIH) released Advancing Science for the Health of Women: The Trans-NIH Strategic Plan for Women’s Health Research, 2019–2023 (Strategic Plan) in February 2019. The NIH Office of Research on Women’s Health (ORWH) engaged staff members from across NIH to develop recommendations on the implementation and evaluation of the Strategic Plan. Objective: This paper describes the process used to develop recommendations for tools and approaches that NIH Institutes, Centers, and Offices (ICOs) could apply when implementing and evaluating the Strategic Plan. Methods: A Trans-NIH Strategic Plan Implementation and Evaluation Guidance Development Team conducted meetings and individual interviews with 69 NIH staff members knowledgeable about research on the health of women and sex and gender differences and met with 11 Advisory Committee on Research on Women’s Health Strategic Plan Evaluation Working Group members. The purpose of these stakeholder meetings and interviews was to obtain recommendations for implementing the Strategic Plan and identify measures for evaluating implementation success. A thematic analysis was performed to synthesize and map the recommendations to the Strategic Plan goals and objectives. Results: The process resulted in the Guide for Implementing and Evaluating the 2019–2023 Trans-NIH Strategic Plan for Women’s Health Research Across NIH Institutes, Centers, and Offices (the Guide), which includes both a conceptual and logic model for implementation and evaluation. Conclusions: The Guide offers methods, tools, and suggestions that ICO planning and evaluation staff, as well as national and international entities, can choose from when determining how to implement the Strategic Plan through ICO activities, programs, and research initiatives and how to evaluate their efforts in the context of their unique mission.

The Association of COVID-19 Infection in Pregnancy With Preterm Birth: A Retrospective Cohort Study in California

Background: Our understanding of the association of coronavirus disease 19 (COVID-19) and preterm or early term birth among racially and ethnically diverse populations and those with chronic medical conditions is limited. Methods: We examined the relationship between COVID-19 and preterm (PTB) birth among live births documented by California Vital Statistics birth certificates between July 2020 and January 2021 (n=240,147). We used best obstetric estimate of gestational age to classify births as very preterm (VPTB, Findings: COVID-19 diagnoses on birth certificates increased for all racial/ethnic groups between July 2020 and January 2021, and was highest for American Indian/Alaska Native (12.9%), Native Hawaiian/Pacific Islander (11.4%), and Latinx (10.3%) birthing people. COVID-19 diagnosis was associated with an increased risk of VPTB (aRR 1.6, 95% CI [1.4, 1.9]), PTB (aRR 1.4, 95% CI [1.3, 1.4]), and early term birth (aRR 1.1, 95% CI [1.1, 1.2]). There was no effect modification of the overall association by race/ethnicity or insurance status. COVID-19 diagnosis was associated with elevated risk of PTB in people with comorbidities. Interpretation: In a large population-based study, COVID-19 diagnosis increased the risk of VPTB, PTB, and early term birth, particularly among those with medical comorbidities. Prevention measures, including vaccination, should be prioritized for birthing persons. Funding Information: UCSF-Kaiser Department of Research Building Interdisciplinary Research Careers in Women’s Health Program (BIRCWH) National Institute of Child Health and Human Development (NICHD) and the Office of Research on Women’s Health (ORWH) [K12 HD052163] and the California Preterm Birth Initiative, funded by Marc and Lynn Benioff.Declaration of Interests: The authors have no conflicts of interest to disclose.Ethics Approval Statement: The Committee for the Protection of Human Subjects (CPHS) within the Health and Human Services Agency of the State of California approved study protocols.

Addressing Health Challenges of Women Across the Life Course: Summary of the Women's Health 2018 Preconference Symposium.

Although the United States is often ahead in both research and health care fields, it lags behind peer countries in many population health indicators. To address these complex health problems that often reflect the intersection of many socioeconomic and health issues, it is essential that scientists work collaboratively across distinct disciplines. Women's health is but one area which can benefit from such an approach given the multifaceted and complex issues underlying the different aspects of women's health research. The National Institutes of Health (NIH) Office of Research on Women's Health (ORWH) and the Office of Women's Health of the U.S. Food and Drug Administration (FDA) cosponsored a preconference symposium at the Women's Health 2018 Conference, held in May in Arlington, VA, to highlight interdisciplinary approaches to research, how researchers can work collaboratively, and how to apply multifaceted approaches to complex real-world problems. Three speakers presented information on a range of subjects related to the health of women across the life course, including the distinction between multidisciplinary, interdisciplinary, and transdisciplinary approaches; the science behind Team Science and how its findings apply to working collaboratively; and gender inequalities in the opioid epidemic. This article summarizes the major points of the presentations and the subsequent discussions.

Abstracts from the NIH Office of Research on Women's Health 2018 Annual BIRCWH Meeting – Building Interdisciplinary Research Careers in Women's Health November 28, 2018

Abstracts from the NIH Office of Research on Women's Health 2018 Annual BIRCWH Meeting – Building Interdisciplinary Research Careers in Women's Health November 28, 2018

Abstract P312: Stress Related to Family Member(s) With Legal/Police Problems and BodyMass Index in the Study of Women’s Health Across the Nation (SWAN)

Introduction: Millions of Americans encounter the legal system each year, although persons of low socioeconomic status and racial/ethnic minorities are disproportionately impacted. The health implications of having legal or police problems have been well-documented, especially among incarcerated populations. Missing from the literature, however, is an insight into the health of those closest to the individuals facing legal and/or police problems—their family. Hypothesis: Using data from the Study of Women’s Health Across the Nation (SWAN), we examined the hypothesis that stress related to family member(s) with legal/police problems (FLPP) is associated with higher body mass index (BMI, kg/m 2 ) across 12 years and examined whether this association varied by education or race. Methods: Participants were 1,550 white, 935 Black, 281 Japanese, and 250 Chinese middle-aged women. Data from baseline through year 13 were analyzed using generalized estimating equations with a year fixed effect. Models were adjusted for site, year, age, race/ethnicity, education, menopausal status, smoking, alcohol use, physical activity, caloric intake, and depressive symptoms. Results: Of the 3,016 women included at baseline, 16.1% of women reported any FLPP, although lower educated women reported more FLPP (20.4%) than higher educated (12.3%) women, and slightly more FLPP than middle educated women (18.9%). Similarly, Black women reported more FLPP (23.8%) than white (14.3%), Japanese (8.5%), and Chinese (7.6%) women. EducationxFLPP interaction was observed such that among lower, but not middle or higher educated women, FLPP that were reported to be very upsetting were on average associated with higher BMI in age, year, race/ethnicity, menopausal status, and site-adjusted models (beta=0.35, p=0.03), although this association became marginal in fully-adjusted models (beta=0.31, p=0.09). Although race/ethnicityxFLPP interaction was not observed, in race-stratified models, very upsetting FLPP were on average marginally associated with increased levels of BMI among Black women only, in both minimally (beta=0.21, p=0.06) and fully-adjusted (beta=0.21, p=0.08) models. Conclusions: Our findings based on 12 years of data suggest that lower educated women and Black women who report having a family member with legal or police problems and who find this very upsetting on average have higher BMI. SWAN has grant support from the National Institutes of Health (NIH), DHHS, through the National Institute on Aging (NIA), the National Institute of Nursing Research (NINR) and the NIH Office of Research on Women’s Health (ORWH) (Grants U01NR004061; U01AG012505, U01AG012535, U01AG012531, U01AG012539, U01AG012546, U01AG012553, U01AG012554, U01AG012495). The content of this abstract is solely the responsibility of the authors and does not necessarily represent the official views of the NIA, NINR, ORWH or the NIH.

As precision medicine becomes more important, is it finally time for increased emphasis on gender medicine?

Gender medicine is the topic of this issue of The Biochemist. In 2014, Francis Collins, Director of the National Institutes of Health (NIH), and Janine Clayton, Director of the Office of Research on Women's Health (ORWH) at NIH, announced that NIH would begin requiring all preclinical grant proposals to address sex as a biological variable1. The ORWH was set up in 1990 with the specific mandate to promote the inclusion of women and minority individuals in all clinical trials going forward2. Similar guidelines are imposed by the European Commission and the Canadian Institutes of Health Research.

Programmatic Efforts at the National Institutes of Health to Promote and Support the Careers of Women in Biomedical Science.

Although women have reached parity at the training level in the biological sciences and medicine, they are still significantly underrepresented in the professoriate and in mid- and senior-level life science positions. Considerable effort has been devoted by individuals and organizations across science sectors to understanding this disparity and to developing interventions in support of women’s career development. The National Institutes of Health (NIH) formed the Office of Research on Women’s Health (ORWH) in 1990 with the goals of supporting initiatives to improve women’s health and providing opportunities and support for the recruitment, retention, reentry, and sustained advancement of women in biomedical careers. Here, the authors review several accomplishments and flagship activities initiated by the NIH and ORWH in support of women’s career development during this time. These include programming to support researchers returning to the workforce after a period away (Research Supplements to Promote Reentry into Biomedical and Behavioral Research Careers), career development awards made through the Building Interdisciplinary Research Careers in Women’s Health program, and trans-NIH involvement and activities stemming from the NIH Working Group on Women in Biomedical Careers. These innovative programs have contributed to advancement of women by supporting the professional and personal needs of women in science. The authors discuss the unique opportunities that accompany NIH partnerships with the scientific community, and conclude with a summary of the impact of these programs on women in science.