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The article focuses on the establishment of the Office of Autoimmune Disease Research (OADR) to advance autoimmune disease research. Topics include the prevalence and impact of autoimmune diseases; challenges in studying environmental exposures and their link to autoimmune conditions; and the strategic initiatives and funding priorities of the OADR to enhance research and address gaps in the field.

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

The article focuses on the significance of interactive scientific and public partnership in the attainment of the vision for 2020 research agenda on women's health of National Institutes of Health's (NIH's) Office of Research on Women's Health (ORWH). It states that the ORWH releases a revised research agenda on women's health that offers an outlook for scientific exploration that aims to increase advances in women's health and sex differences research. It mentions that one of the tasks of ORWH is to interact with the scientific and medical communities, organizations and other parts of government that concern in women's health. It says that ORWH conducts several meetings wherein participants contribute their ideas and suggestions for the research agenda.

This Viewpoint summarizes provisions of the National Institutes of Health's Inclusion Across the Lifespan policy scheduled for implementation in 2019 for clinical trials, which will require written plans to recruit younger and older participants as a part of grant applications and documentation of participant age in trial progress reports. [ABSTRACT FROM AUTHOR]

An introduction to the journal is presented wherein the editor discusses various reports published within the issue which include topics covered during a research symposium held in late 2013 including "Vision for the Future" which highlights gaps in research on screening and counseling for intimate partner violence (IPV) identified during the meeting.

The health of women remains understudied. In response to a request from Congress, the Office of Research on Women's Health of the National Institutes of Health (NIH) evaluated research on the health of women currently underway related to 1) rising rates of maternal morbidity and mortality, 2) rising rates of chronic debilitating conditions in women, and 3) stagnant cervical cancer survival rates. Input on the three priority areas was obtained from experts in women's health, members of the public, and federal stakeholders. The NIH research portfolios on these three topics were reviewed. On October 20, 2021, a conference on advancing NIH research on women's health was held to present, discuss, and delineate gaps and opportunities in the current portfolio. Across the life course, significant gaps in evidence regarding conditions, disorders, and diseases that occur in women were illustrated. Fundamental basic and translational knowledge gaps in many female-specific conditions and diseases with sex-specific presentations, symptoms, or responses to treatments have hampered the generation of robust scientific data needed to provide high-quality, evidence-based care to women. Key opportunities identified to improve the health of women include enhanced implementation of existing best practices and interventions to reduce disparities. Undertaking intentional clinical research on the health of women will produce significant returns on investment and has the potential to greatly improve human health. [ABSTRACT FROM AUTHOR]

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 performancebased 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. [ABSTRACT FROM AUTHOR]

The human brain undergoes rapid development during the first years of life. Beginning in utero, a wide array of biological, social, and environmental factors can have lasting impacts on brain structure and function. To understand how prenatal and early life experiences alter neurodevelopmental trajectories and shape health outcomes, several NIH Institutes, Centers, and Offices collaborated to support and launch the HEALthy Brain and Child Development (HBCD) Study. The HBCD Study is a multi-site prospective longitudinal cohort study, that will examine human brain, cognitive, behavioral, social, and emotional development beginning prenatally and planned through early childhood. Influenced by the success of the ongoing Adolescent Brain Cognitive Development SM Study (ABCD Study®) and in partnership with the NIH Helping to End Addiction Long-term® Initiative, or NIH HEAL Initiative®, the HBCD Study aims to establish a diverse cohort of over 7000 pregnant participants to understand how early life experiences, including prenatal exposure to addictive substances and adverse social environments as well as their interactions with an individual's genes, can affect neurodevelopmental trajectories and outcomes. Knowledge gained from the HBCD Study will help identify targets for early interventions and inform policies that promote resilience and mitigate the neurodevelopmental effects of adverse childhood experiences and environments., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests. Julia L. Zehr reports a relationship with Jazz Pharmaceuticals Inc that includes: equity or stocks. Co-author’s spouse is employed by Jazz Pharmaceuticals, Inc - JLZ If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper, (Copyright © 2024. Published by Elsevier Ltd.)

The National Institute of Health (NIH) policy, Consideration of Sex as a Biological Variable (SABV) in NIH-funded Research (2015), focuses on the expectation that researchers account for the influence of SABV in vertebrate animal and human studies and provide a strong justification for single-sex investigations. When SABV is considered in the research design, data analyses, and reporting, the rigor and reproducibility of the research are elevated and inform best practices and precision health for all people. Additional recommendations include the appropriate use of terminology, integration into curricula, intersection with social determinants of health, and application of sex and gender equity guidelines when disseminating research. This paper is a "call to action" for nurse researchers to lean into and apply this policy's principles and our recommendations, from the bench to the bedside, to advance the equity and health of all people., Competing Interests: Declaration of Competing Interest The authors declare no conflicts of interest., (Published by Elsevier Inc.)

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., (Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.)

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., (© 2024 The Authors. Journal of Dental Education published by Wiley Periodicals LLC on behalf of American Dental Education Association.)

Rising rates of chronic conditions were cited as one of the key public health concerns in the Fiscal Year (FY) 2021 U.S. Senate and House of Representatives appropriations bills, where a review of current National Institutes of Health (NIH) portfolios relevant to research on women's health was requested. Chronic conditions were last defined by the US Department of Health and Human Services (HHS) in 2010. However, existing definitions of chronic conditions do not incorporate sex or gender considerations. Sex and gender influence health, yet significant knowledge gaps exist in the evidence-base for prevention, diagnosis, and treatment of chronic diseases amongst women. The presentation, prevalence, and long-term effects of chronic conditions and multimorbidity differs in women from men. A clinical framework was developed to adequately assess the NIH investment in research related to chronic conditions in women. The public health needs and NIH investment related to conditions included in the framework were measured. By available measures, research within the NIH has not mapped to the burden of chronic conditions among women. Clinical research questions and endpoints centered around women can be developed and implemented; clinical trials networks with expanded or extended eligibility criteria can be created; and data science could be used to extrapolate the effects of overlapping or multiple morbidities on the health of women. Aligning NIH research priorities to address the specific needs of women with chronic diseases is critical to addressing women's health needs from a life course perspective., (© 2023. This is a U.S. Government work and not under copyright protection in the US; foreign copyright protection may apply.)

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.

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., Competing Interests: Declarations of Competing Interest None., (Published by Elsevier Inc.)

A little over 5 years ago, the U.S. National Institutes of Health (NIH) announced the intention to develop policies to require applicants to report plans to balance male and female cells and animals in preclinical investigations. Soon thereafter, the NIH issued a request for information from the scientific community and consulted with various stakeholders. The feedback received was considered during development of policy requiring the consideration of sex as a biological variable (SABV) in NIH-funded research on vertebrate animals and humans, which went into effect for applications due on or after January 25, 2016. We identified NIH programs related to SABV and reviewed SABV-relevant scientific literature. We find that the application of SABV throughout the research process can serve as a guiding principle to improve the value of biomedical science. The NIH is engaged in ongoing efforts to develop resources to help investigators consider SABV in their research. We also provide an update on lessons learned, highlight ways that different disciplines consider SABV, and describe the opportunities for scientific discovery that applying SABV offers. We call on NIH's various stakeholders to redouble their efforts to integrate SABV throughout the biomedical research enterprise. Sex- and gender-aware investigations are critical to the conduct of rigorous and transparent science and the advancement of personalized medicine. This kind of research achieves its greatest potential when sex and gender considerations are integrated into the biomedical research enterprise in an end-to-end manner, from basic and preclinical investigations, through translational and clinical research, to improved health care delivery.

Female sex/gender is an undercharacterized variable in studies related to lung development and disease. Notwithstanding, many aspects of lung and sleep biology and pathobiology are impacted by female sex and female reproductive transitions. These may manifest as differential gene expression or peculiar organ development. Some conditions are more prevalent in women, such as asthma and insomnia, or, in the case of lymphangioleiomyomatosis, are seen almost exclusively in women. In other diseases, presentation differs, such as the higher frequency of exacerbations experienced by women with chronic obstructive pulmonary disease or greater cardiac morbidity among women with sleep-disordered breathing. Recent advances in -omics and behavioral science provide an opportunity to specifically address sex-based differences and explore research needs and opportunities that will elucidate biochemical pathways, thus enabling more targeted/personalized therapies. To explore the status of and opportunities for research in this area, the NHLBI, in partnership with the NIH Office of Research on Women's Health and the Office of Rare Diseases Research, convened a workshop of investigators in Bethesda, Maryland on September 18 and 19, 2017. At the workshop, the participants reviewed the current understanding of the biological, behavioral, and clinical implications of female sex and gender on lung and sleep health and disease, and formulated recommendations that address research gaps, with a view to achieving better health outcomes through more precise management of female patients with nonneoplastic lung disease. This report summarizes those discussions.

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.

Sex as a biological variable (SABV) is a key part of the new National Institutes of Health (NIH) initiative to enhance reproducibility through rigor and transparency. The SABV policy requires researchers to factor sex into the design, analysis, and reporting of vertebrate animal and human studies. The policy was implemented as it has become increasingly clear that male/female differences extend well beyond reproductive and hormonal issues. Implementation of the policy is also meant to address inattention to sex influences in biomedical research. Sex affects: cell physiology, metabolism, and many other biological functions; symptoms and manifestations of disease; and responses to treatment. For example, sex has profound influences in neuroscience, from circuitry to physiology to pain perception. Extending beyond the robust efforts of NIH to ensure that women are included in clinical trials, the SABV policy also includes rigorous preclinical experimental designs that inform clinical research. Additionally, the NIH has engaged journal editors and publishers to facilitate reproducibility by addressing rigor and promoting transparency through scientifically appropriate sex-specific study results reporting. The Sex And Gender Equity in Research (SAGER) guidelines were developed to assist researchers and journal editors in reporting sex and gender information in publications [1]., (Published by Elsevier Inc.)

In May 2014, the U.S. National Institutes of Health (NIH) announced that it will ensure that investigators account for sex as a biological variable (SABV) in NIH-funded preclinical research as part of the agency's rigor and transparency initiative. Herein, I describe in more detail the rationale behind the SABV policy component and provide additional detail about policy goals. In short, studying both sexes is a guiding principle in biomedical research that will expand knowledge toward turning discovery into health. NIH expects that considering SABV in preclinical research will help to build a knowledge base that better informs the design of clinical research and trials in humans. Integrating the practice of studying both sexes in preclinical research will, over time, expand our currently incomplete knowledge base that plays a critical role in informing the development of sex- and gender-appropriate medical care for women and men., (© FASEB.)

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.

Our eyes are, both literally and figuratively, windows to the world, and ophthalmic approaches offer a tremendous space for conducting research to learn more. Male/female differences in ocular health and disease are prevalent but we know far too little about root causes to design and implement diagnostic, preventive, and treatment strategies to address sex- and gender-based disparities in eye health. Herein, we discuss several ophthalmic diseases and other conditions with ocular manifestations, with a focus upon those that disproportionately affect women. Because the vast majority of biomedical research in this area comes from studies of mixed-gender populations, or of male-predominant populations, there is a pressing need for sex- and/or gender-based research at various points along the basic to clinical biomedical research continuum. Moreover, the multitude of factors that affect eye health call for a balanced look at the influence of biology, culture, and societal contributors. As clinicians, we owe our patients the best care for their needs, and that care must be derived from research that shows what is effective, for whom, and under what conditions.

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., (Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.)

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., (Published by Elsevier Inc.)

The lack of standardized criteria for measuring therapeutic response is a major obstacle to the development of new therapeutic agents for chronic graft-versus-host disease (cGVHD). National Institutes of Health (NIH) consensus criteria for evaluating therapeutic response were published in 2006. We report the results of 4 consecutive pilot trials evaluating the feasibility and estimating the interrater reliability and minimum detectable change of these response criteria. Hematology-oncology clinicians with limited experience in applying the NIH cGVHD response criteria (n = 34) participated in a 2.5-hour training session on response evaluation in cGVHD. Feasibility and interrater reliability between subspecialty cGVHD experts and this panel of clinician raters were examined in a sample of 25 children and adults with cGVHD. The minimum detectable change was calculated using the standard error of measurement. Clinicians' impressions of the brief training session, the photo atlas, and the response criteria documentation tools were generally favorable. Performing and documenting the full set of response evaluations required a median of 21 minutes (range: 12-60 minutes) per rater. The Schirmer tear test required the greatest time of any single test (median: 9 minutes). Overall, interrater agreement for skin and oral manifestations was modest; however, in the third and fourth trials, the agreement between clinicians and experts for all dimensions except movable sclerosis approached satisfactory values. In the final 2 trials, the threshold for defining change exceeding measurement error was 19% to 22% body surface area (BSA) for erythema, 18% to 26% BSA for movable sclerosis, 17% to 21% BSA for nonmovable sclerosis, and 2.1 to 2.6 points on the 15-point NIH Oral cGHVD scale. Agreement between clinician-expert pairs was moderate to substantial for the measures of functional capacity and for the gastrointestinal and global cGVHD rating scales. These results suggest that the NIH response criteria are feasible for use, and these reliability estimates are encouraging, because they were observed following a single 2.5-hour training session given at multiple transplant centers, with no opportunity for iterative training and calibration. Research is needed to evaluate inter- and intrarater reliability in larger samples, and to evaluate these response criteria as predictors of outcomes in clinical trials., (Published by Elsevier Inc.)

Clinical research investigates mechanisms of human disease, interventions, or new technologies, but pregnant women are often excluded from clinical studies. Few studies, beyond research on pregnancy, are designed to address questions relevant to pregnant women. A recent National Institutes of Health workshop considered the barriers and opportunities in conducting clinical research studies enrolling pregnant women.