scholarly journals Considering Sex as a Biological Variable in Basic and Clinical Studies: An Endocrine Society Scientific Statement

2021 ◽  
Author(s):  
Aditi Bhargava ◽  
Arthur P Arnold ◽  
Debra A Bangasser ◽  
Kate M Denton ◽  
Arpana Gupta ◽  
...  
Keyword(s):  
Sex Differences ◽  
Cultured Cells ◽  
Human Subjects ◽  
Basic Research ◽  
Experimental Manipulation ◽  
Lessons Learned ◽  
Sex And Gender ◽  
Endocrine Society ◽  
Biological Variable ◽  
And Gender

Abstract In May 2014, the National Institutes of Health (NIH) stated its intent to “require applicants to consider sex as a biological variable (SABV) in the design and analysis of NIH-funded research involving animals and cells.” Since then, proposed research plans that include animals routinely state that both sexes/genders will be used; however, in many instances, researchers and reviewers are at a loss about the issue of sex differences. Moreover, the terms sex and gender are used interchangeably by many researchers, further complicating the issue. In addition, the sex or gender of the researcher might influence study outcomes, especially those concerning behavioral studies, in both animals and humans. The act of observation may change the outcome (the “observer effect”) and any experimental manipulation, no matter how well-controlled, is subject to it. This is nowhere more applicable than in physiology and behavior. The sex of established cultured cell lines is another issue, in addition to aneuploidy; chromosomal numbers can change as cells are passaged. Additionally, culture medium contains steroids, growth hormone, and insulin that might influence expression of various genes. These issues often are not taken into account, determined, or even considered. Issues pertaining to the “sex” of cultured cells are beyond the scope of this Statement. However, we will discuss the factors that influence sex and gender in both basic research (that using animal models) and clinical research (that involving human subjects), as well as in some areas of science where sex differences are routinely studied. Sex differences in baseline physiology and associated mechanisms form the foundation for understanding sex differences in diseases pathology, treatments, and outcomes. The purpose of this Statement is to highlight lessons learned, caveats, and what to consider when evaluating data pertaining to sex differences, using 3 areas of research as examples; it is not intended to serve as a guideline for research design.

scholarly journals The Integration of Sex and Gender Considerations into Biomedical Research: Lessons from International Funding Agencies

2021 ◽  
Author(s):  
Jamie White ◽  
Cara Tannenbaum ◽  
Ineke Klinge ◽  
Londa Schiebinger ◽  
Janine Clayton
Keyword(s):  
Biomedical Research ◽  
Lessons Learned ◽  
Gender Effects ◽  
Sex And Gender ◽  
Personalized Care ◽  
Research And Innovation ◽  
Biological Variable ◽  
Funding Agencies ◽  
Gender Based ◽  
And Gender

Abstract 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 Institute for Health Research (CIHR), and the European Commission (EC) began 1) requesting that applicants address sex and gender considerations in grant proposals and 2) 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 of both 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, healthcare 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 system-wide 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.

scholarly journals Sex differences in sleep: impact of biological sex and sex steroids

2016 ◽  
Vol 371 (1688) ◽  
pp. 20150110 ◽  
Author(s):  
Jessica A. Mong ◽  
Danielle M. Cusmano
Keyword(s):  
Sex Differences ◽  
Sex Steroids ◽  
Basic Research ◽  
Sex And Gender ◽  
Clinical Perspective ◽  
Biological Sex ◽  
Sleep Behaviour ◽  
Sex Disparities ◽  
And Gender ◽  
Sex And Gender Differences

Men and women sleep differently. While much is known about the mechanisms that drive sleep, the reason for these sex differences in sleep behaviour is unknown and understudied. Historically, women and female animals are underrepresented in studies of sleep and its disorders. Nevertheless, there is a growing recognition of sex disparities in sleep and rhythm disorders. Women typically report poorer quality and more disrupted sleep across various stages of life. Findings from clinical and basic research studies strongly implicate a role for sex steroids in sleep modulation. Understanding how neuroendocrine mediators and sex differences influence sleep is central to advancing our understanding of sleep-related disorders. The investigation into sex differences and sex steroid modulation of sleep is in its infancy. Identifying the mechanisms underlying sex and gender differences in sleep will provide valuable insights leading to tailored therapeutics that benefit each sex. The goal of this review is to discuss our current understanding of how biological sex and sex steroids influence sleep behaviour from both the clinical and pre-clinical perspective.

scholarly journals Elucidating the Relationship Between Insomnia, Sex, and Cardiovascular Disease

2020 ◽  
Vol 4 ◽  
pp. 247028972098001
Author(s):  
Rebecca Leeds ◽  
Ari Shechter ◽  
Carmela Alcantara ◽  
Brooke Aggarwal ◽  
John Usseglio ◽  
...  
Keyword(s):  
Cardiovascular Disease ◽  
Sex Differences ◽  
Cardiovascular Health ◽  
Future Research ◽  
Sex And Gender ◽  
Men And Women ◽  
Sex Research ◽  
And Gender ◽  
The Relationship ◽  
Cvd Mortality

Sex differences in cardiovascular disease (CVD) mortality have been attributed to differences in pathophysiology between men and women and to disparities in CVD management that disproportionately affect women compared to men. Similarly, there has been investigation of differences in the prevalence and presentation of insomnia attributable to sex. Few studies have examined how sex and insomnia interact to influence CVD outcomes, however. In this review, we summarize the literature on sex-specific differences in the prevalence and presentation of insomnia as well as existing research regarding the relationship between insomnia and CVD outcomes as it pertains to sex. Research to date indicate that women are more likely to have insomnia than men, and there appear to be differential associations in the relation between insomnia and CVD by sex. We posit potential mechanisms of the relationship between sex, insomnia and CVD, discuss gaps in the existing literature, and provide commentary on future research needed in this area. Unraveling the complex relations between sex, insomnia, and CVD may help to explain sex-specific differences in CVD, and identify sex-specific strategies for promotion of cardiovascular health. Throughout this review, terms “men” and “women” are used as they are in the source literature, which does not differentiate between sex and gender. The implications of this are also discussed.

scholarly journals Sex as a Prognostic Factor in Systematic Reviews: Challenges and Lessons Learned

2021 ◽  
Vol 11 (6) ◽  
pp. 441
Author(s):  
Elena Stallings ◽  
Alba Antequera ◽  
Jesús López-Alcalde ◽  
Miguel García-Martín ◽  
Gerard Urrútia ◽  
...  
Keyword(s):  
Prognostic Factor ◽  
Systematic Reviews ◽  
Lessons Learned ◽  
Disease State ◽  
Sex And Gender ◽  
Funding Agencies ◽  
And Gender ◽  
Baseline Factor ◽  
Clinical Domain ◽  
Made In

Sex is a common baseline factor collected in studies that has the potential to be a prognostic factor (PF) in several clinical areas. In recent years, research on sex as a PF has increased; however, this influx of new studies frequently shows conflicting results across the same treatment or disease state. Thus, systematic reviews (SRs) addressing sex as a PF may help us to better understand diseases and further personalize healthcare. We wrote this article to offer insights into the challenges we encountered when conducting SRs on sex as a PF and suggestions on how to overcome these obstacles, regardless of the clinical domain. When carrying out a PF SR with sex as the index factor, it is important to keep in mind the modifications that must be made in various SR stages, such as modifying the PF section of CHARMS-PF, adjusting certain sections of QUIPS and extracting data on the sex and gender terms used throughout the studies. In this paper, we provide an overview of the lessons learned from carrying out our reviews on sex as a PF in different disciplines and now call on researchers, funding agencies and journals to realize the importance of studying sex as a PF.

scholarly journals Multifaceted origins of sex differences in the brain

2016 ◽  
Vol 371 (1688) ◽  
pp. 20150106 ◽  
Author(s):  
Margaret M. McCarthy
Keyword(s):  
Sex Differences ◽  
State Of The Art ◽  
Human Subjects ◽  
Special Issue ◽  
Molecular Analyses ◽  
The Past ◽  
Current State ◽  
Biological Variable ◽  
Males And Females ◽  
The Brain

Studies of sex differences in the brain range from reductionistic cell and molecular analyses in animal models to functional imaging in awake human subjects, with many other levels in between. Interpretations and conclusions about the importance of particular differences often vary with differing levels of analyses and can lead to discord and dissent. In the past two decades, the range of neurobiological, psychological and psychiatric endpoints found to differ between males and females has expanded beyond reproduction into every aspect of the healthy and diseased brain, and thereby demands our attention. A greater understanding of all aspects of neural functioning will only be achieved by incorporating sex as a biological variable. The goal of this review is to highlight the current state of the art of the discipline of sex differences research with an emphasis on the brain and to contextualize the articles appearing in the accompanying special issue.

Everything You Wanted to Know About Sex Differences, but Were Afraid to Be Perceived as Politically Incorrect: Brain Gender, by M. Hines. 2004. New York: Oxford University Press. 307 pp., $49.50.

2004 ◽  
Vol 10 (7) ◽  
pp. 1026-1027
Author(s):  
Jeannette McGlone
Keyword(s):  
New York ◽  
Sex Differences ◽  
Sex And Gender ◽  
Oxford University ◽  
And Gender ◽  
Oxford University Press

Hines finds it impossible to make distinctions between the terms “sex” and “gender,” hence their refreshing, non-political interchangeability in her new book. After examining hormonal and brain-based data, Hines concludes that science cannot yet inform us which differences are determined biologically, socially, and/or both.

scholarly journals Sex and Gender Differences in Central Nervous System-Related Disorders

2016 ◽  
Vol 2016 ◽  
pp. 1-13 ◽  
Author(s):  
Emanuela Zagni ◽  
Lucia Simoni ◽  
Delia Colombo
Keyword(s):  
Sex Differences ◽  
Brain Diseases ◽  
Sex And Gender ◽  
Neuronal Structure ◽  
Clinical Literature ◽  
The Usa ◽  
Psychosocial Influences ◽  
And Gender ◽  
Or Genes ◽  
The Brain

There are important sex differences in the brain that seem to arise from biology as well as psychosocial influences. Sex differences in several aspects of human behavior and cognition have been reported. Gonadal sex steroids or genes found on sex chromosomes influence sex differences in neuroanatomy, neurochemistry and neuronal structure, and connectivity. There has been some resistance to accept that sex differences in the human brain exist and have biological relevance; however, a few years ago, it has been recommended by the USA National Institute of Mental Health to incorporate sex as a variable in experimental and clinical neurological and psychiatric studies. We here review the clinical literature on sex differences in pain and neurological and psychiatric diseases, with the aim to further stimulate interest in sexual dimorphisms in the brain and brain diseases, possibly encouraging more research in the field of the implications of sex differences for treating these conditions.

scholarly journals Sex and gender differences in hypertensive kidney injury

2017 ◽  
Vol 313 (4) ◽  
pp. F1009-F1017 ◽  
Author(s):  
Jennifer C. Sullivan ◽  
Ellen E. Gillis
Keyword(s):  
Sex Differences ◽  
Experimental Animal ◽  
Animal Studies ◽  
Molecular Mechanisms ◽  
Kidney Injury ◽  
Science Research ◽  
The United States ◽  
Sex And Gender ◽  
Participation Of Women ◽  
And Gender

Hypertension is a complex, multifaceted disorder, affecting ~1 in 3 adults in the United States. Although hypertension occurs in both men and women, there are distinct sex differences in the way in which they develop hypertension, with women having a lower incidence of hypertension until the sixth decade of life. Despite observed sex differences in hypertension, little is known about the molecular mechanisms underlying the development of hypertension in females, primarily because of their underrepresentation in both clinical and experimental animal studies. The first goal of this review is to provide a concise overview of the participation of women in clinical trials, including a discussion of the importance of including females in basic science research, as recently mandated by the National Institutes of Health. The remaining portion of the review is dedicated to identifying clinical and experimental animal studies that concentrate on gender and sex differences in hypertensive kidney disease, ending with a proposed role for T cells in mediating sex differences in blood pressure.

scholarly journals Engaging Emergency Medicine Influencers in Sex‐ and Gender‐based Medicine: Lessons Learned from the Sex and Gender Interest Group in Emergency Medicine and the SAEM Jeopardy Game

2019 ◽  
Vol 4 (2) ◽  
pp. 161-165
Author(s):  
Jeannette Wolfe ◽  
Basmah Safdar ◽  
Kinjal N. Sethuraman ◽  
Marna R. Greenberg ◽  
Tracy E. Madsen ◽  
...  
Keyword(s):  
Emergency Medicine ◽  
Interest Group ◽  
Lessons Learned ◽  
Sex And Gender ◽  
Gender Based ◽  
And Gender ◽  
Based Medicine
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