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 ◽  
...  

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.

Author(s):  
Jamie White ◽  
Cara Tannenbaum ◽  
Ineke Klinge ◽  
Londa Schiebinger ◽  
Janine Clayton

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.


2019 ◽  
Vol 4 (2) ◽  
pp. 161-165
Author(s):  
Jeannette Wolfe ◽  
Basmah Safdar ◽  
Kinjal N. Sethuraman ◽  
Marna R. Greenberg ◽  
Tracy E. Madsen ◽  
...  

2021 ◽  
Author(s):  
Aditi Bhargava ◽  
Arthur P Arnold ◽  
Debra A Bangasser ◽  
Kate M Denton ◽  
Arpana Gupta ◽  
...  

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.


2018 ◽  
Vol 39 (4) ◽  
pp. 424-439 ◽  
Author(s):  
Janet W Rich-Edwards ◽  
Ursula B Kaiser ◽  
Grace L Chen ◽  
JoAnn E Manson ◽  
Jill M Goldstein

Abstract A sex- and gender-informed perspective increases rigor, promotes discovery, and expands the relevance of biomedical research. In the current era of accountability to present data for males and females, thoughtful and deliberate methodology can improve study design and inference in sex and gender differences research. We address issues of motivation, subject selection, sample size, data collection, analysis, and interpretation, considering implications for basic, clinical, and population research. In particular, we focus on methods to test sex/gender differences as effect modification or interaction, and discuss why some inferences from sex-stratified data should be viewed with caution. Without careful methodology, the pursuit of sex difference research, despite a mandate from funding agencies, will result in a literature of contradiction. However, given the historic lack of attention to sex differences, the absence of evidence for sex differences is not necessarily evidence of the absence of sex differences. Thoughtfully conceived and conducted sex and gender differences research is needed to drive scientific and therapeutic discovery for all sexes and genders.


2021 ◽  
Vol 118 (6) ◽  
pp. e2023476118
Author(s):  
Holly O. Witteman ◽  
Jenna Haverfield ◽  
Cara Tannenbaum

With more time being spent on caregiving responsibilities during the COVID-19 pandemic, female scientists’ productivity dropped. When female scientists conduct research, identity factors are better incorporated in research content. In order to mitigate damage to the research enterprise, funding agencies can play a role by putting in place gender equity policies that support all applicants and ensure research quality. A national health research funder implemented gender policy changes that included extending deadlines and factoring sex and gender into COVID-19 grant requirements. Following these changes, the funder received more applications from female scientists, awarded a greater proportion of grants to female compared to male scientists, and received and funded more grant applications that considered sex and gender in the content of COVID-19 research. Further work is urgently required to address inequities associated with identity characteristics beyond gender.


ASHA Leader ◽  
2018 ◽  
Vol 23 (2) ◽  
pp. 4-4
Keyword(s):  

2012 ◽  
Vol 220 (2) ◽  
pp. 57-60 ◽  
Author(s):  
Markus Hausmann ◽  
Barbara Schober

Sign in / Sign up

Export Citation Format

Share Document