BioInnovation Institute’s Post

💡 Did you know that until the 1990s, most health research was conducted primarily by men, on men? ♀ Today is #InternationWomensDay. On this occasion, I felt the need to write and raise awareness about the sex bias that existed - and still remain - in biomedical research and clinical trials. Over the past decades, the scientific literature has reported an impressive number of studies showing differences between the sexes in terms of pathological risks, treatment effectiveness and disease outcomes. Precision medicine is increasingly recognized as a new therapeutic approach of reference in the world of researchers and clinicians. Given these major technological advances, it seems insane that sex, the most obvious biological variable in humans, has been largely neglected in biomedical research. There is still a need for awareness, education and advocacy to consider sex as a biological variable. Read more --> https://lnkd.in/eTq3c9yy

“Female subjects are too complicated for research.” “Female bodies are too variable: their hormonal cycles will mess up our data.” If you cringed at these statements, read on. If you didn’t, definitely read on. 🌶 After all, it's #FemaleHealthFriday, and you know I like to keep it spicy! 🌶 For years, all disciplines of biomedical research have fallen prey to the argument that #female bodies are too complicated, too variable, too unpredictable to be included in #research studies. (Background: scientists worldwide have long justified the exclusive use of male study participants by citing the argument that the ovarian cycle rhythms of females will create too much variation in their body temperature, among other metrics.) Interestingly, multiple animal studies have disproven this hypothesis, showing that male and female animals have similar patterns of variation in body temperature (Prendergast, et al., 2014; Becker, et al., 2016). 🤯 For some physiologic measurements, male animals were even more variable than females (Prendergast, et al. 2014). 🤯 Despite overwhelming evidence showing that it’s unwarranted, this bias against female participants exists to this day in all disciplines of #biomedical research, from lab bench experiments with animal models to full-scale clinical trials (Yoon, et al., 2014; Feldman, et al., 2019). 🌊 Fortunately, the tides are changing. 🌊 In 2016, the National Institutes of Health enacted a policy on the study of sex as a biological variable in research. Investigators applying for NIH funding must now provide “strong justification from the scientific literature, preliminary data, or other relevant considerations…for applications proposing to study only one sex.” (Office of Research on Women’s Health) However, this policy only applies to research funded by the NIH: while some such studies include international collaborations, others are restricted to North American populations. It takes time for sweeping changes like this to permeate global research efforts. Science and medicine advance through global cooperation and the exchange of data. Research findings from the US influence the ideas and study design of scientists in China, Europe, Africa, and beyond…and the converse is also true. 🌍 The #sexbias in data is a #globalhealth issue. 🌏 Next week, I’ll continue this investigation of international research on sex differences, and we’ll discuss how #wearables have the potential to level the playing field for female bodies in global health research - stay tuned! 🧬 #sexbias #genderbias #womenshealthmatters #lgbtqhealth #healthequity #womxn #medicalresearch #clinicalresearch ~~~~~~~~~~~ Hey there! I’m Dr. Caitlyn Tivy, a clinical consultant and medical writer for women’s and LGBTQ+ health companies. I help #femtech and queer health organizations develop scientifically accurate information and products. Ready to take your femtech or queer health company to the next level? Let’s connect! ♀ 🏳️🌈

📃Scientific paper: Modeling the relative influence of socio-demographic variables on post-acute COVID-19 quality of life Abstract: BACKGROUND: Post-acute sequelae of SARS-CoV-2, referred to as “long COVID”, are a globally pervasive threat. While their many clinical determinants are commonly considered, their plausible social correlates are often overlooked. METHODS: Here, we use data from a multinational prospective cohort study to compare social and clinical predictors of differences in quality of life with long COVID. We further measure the extent to which clinical intermediates may explain relationships between social variables and quality of life with long COVID. FINDINGS: Beyond age, neuropsychological and rheumatological comorbidities, educational attainment, employment status, and female sex were important predictors of long COVID-associated quality of life days (long COVID QALDs). Furthermore, most of their associations could not be attributed to key long COVID-predicting comorbidities. In Norway, 90% (95% CI: 77%, 100%) of the adjusted association between belonging to the top two quintiles of educational attainment and long COVID QALDs was not explained by these clinical intermediates. The same was true for 86% (73%, 100%) and 93% (80%,100%) of the adjusted association between full-time employment and long COVID QALDs in the United Kingdom (UK) and Russia. Additionally, 77% (46%,100%) and 73% (52%, 94%) of the adjusted associations between female sex and long COVID QALDs in Norway and the UK were unexplained by the clinical mediators. INTERPRETATION: Our findings highlight that socio-... Continued on ES/IODE ➡️ https://etcse.fr/zvU ------- If you find this interesting, feel free to follow, comment and share. We need your help to enhance our visibility, so that our platform continues to serve you.

The Intersection of Sex and Gender Influences on Health and Disease (R01 Clinical Trial Optional) The purpose of this Funding Opportunity Announcement (FOA) is to invite R01 applications on the influence and intersection of sex and gender in health and disease, including: (1) research applications that examine sex and gender factors and their intersection in understanding health and disease; and (2) research that addresses one of the five objectives from Strategic Goal 1 of the 2019-2023 Trans-NIH Strategic Plan for Women's Health Research "Advancing Science for the Health of Women." The awards under this FOA will be administered by NIH ICs using funds that have been made available through the Office of Research on Women’s Health (ORWH) and the scientific partnering Institutes and Centers across NIH. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. ORWH and partner components intend to commit an estimated total of $3 million to fund up to 7 awards per receipt date. The number of awards depends on the size and scope of the most meritorious applications, scientific programmatic interest, and availability of funds.

📃Scientific paper: Modeling the relative influence of socio-demographic variables on post-acute COVID-19 quality of life Abstract: BACKGROUND: Post-acute sequelae of SARS-CoV-2, referred to as “long COVID”, are a globally pervasive threat. While their many clinical determinants are commonly considered, their plausible social correlates are often overlooked. METHODS: Here, we use data from a multinational prospective cohort study to compare social and clinical predictors of differences in quality of life with long COVID. We further measure the extent to which clinical intermediates may explain relationships between social variables and quality of life with long COVID. FINDINGS: Beyond age, neuropsychological and rheumatological comorbidities, educational attainment, employment status, and female sex were important predictors of long COVID-associated quality of life days (long COVID QALDs). Furthermore, most of their associations could not be attributed to key long COVID-predicting comorbidities. In Norway, 90% (95% CI: 77%, 100%) of the adjusted association between belonging to the top two quintiles of educational attainment and long COVID QALDs was not explained by these clinical intermediates. The same was true for 86% (73%, 100%) and 93% (80%,100%) of the adjusted association between full-time employment and long COVID QALDs in the United Kingdom (UK) and Russia. Additionally, 77% (46%,100%) and 73% (52%, 94%) of the adjusted associations between female sex and long COVID QALDs in Norway and the UK were unexplained by the clinical mediators. INTERPRETATION: Our findings highlight that socio-... Continued on ES/IODE ➡️ https://etcse.fr/zvU ------- If you find this interesting, feel free to follow, comment and share. We need your help to enhance our visibility, so that our platform continues to serve you.

Did you know that the Department of Defense is now requiring both women and men to be included in medical research? The Fiscal Year 2025 (FY25) Congressionally Directed Medical Research Programs (CDMRP) Policy on Sex as a Biological Variable (SABV) in Research and associated changes to application requirements is going into effect, which means beginning with applications submitted to FY25 funding opportunities, the CDMRP expects researchers to study both males and females unless there is a strong justification from the scientific literature, preliminary data, or other relevant considerations for only studying one sex. This policy applies to all applications and awards for CDMRP-supported research involving vertebrate animals, humans and/or material of human origin (e.g., cadaveric specimens, tissues, cell lines, and their derived data) where the sexes are known. Also, all applicants will be required to include a strategy for considering SABV and, for studies that will consider SABV by including both sexes, applicants will be expected to develop a data analysis plan prospectively that, at a minimum, will collect data disaggregated by sex. In Department of Defense reports and peer-reviewed publications, funded investigators will be required to acknowledge limitations in the applicability of findings that may arise from the samples, methods, and analyses used and report sex-based differences and/or disaggregate data based on sex where possible. #womenshealth #medicalresearch #grants #funding Women's Health Access Matters Society for Women's Health Research (SWHR) Alliance for Women's Health & Prevention HealthyWomen Black Women's Health Imperative American Medical Women's Association (AMWA) National Hispanic Medical Association (NHMA) National Medical Association National Organization for Rare Disorders American Medical Association Women's Congressional Policy Institute Women's Health Research Institute (WHRI) Mary Horrigan Connors Center for Women's Health and Gender Biology Magee-Womens Research Institute & Foundation G2G - Innovative Government Affairs Consulting

Did you know that Saccular unruptured intracranial aneurysms (UIAs), are a silent threat, lurking within the walls of the intracranial arteries, with a higher risk in women than men? 🤔 The Women's Brain Foundation works relentlessly to understand the sex and gender characteristics impacting brain and mental health. Today, our dedicated scientists have published a critical piece on this topic: “Sex differences and possible applications of artificial intelligence in saccular unruptured intracranial aneurysms. A narrative review” The main learnings from this manuscript: 1) Saccular UIAs are more prevalent among females than males, in over 50-year-old patients, the female-to-male prevalence ratio of UIA gets as high as 2.2:1! 2) These sex differences might have a connection to estrogen hormones and their influences on reproductive aging, the anatomy of cerebral arteries, and inflammatory processes. 3) AI has not yet been used to address sex- and gender differences in this field. It would be extremely relevant to train AI to factor in sex- and gender differences in aneurysm development and manifestation, enhancing the accuracy of current UIA screening techniques. A heartfelt thanks to everyone who collaborated on this project; your contributions were incredibly valuable! ⭐ Adelaide J., Luca Gambini-Rossano, Dr. Ing., Joanna Schaafsma, Dr. Risvin Naser, Julie N., Simona Mellino, PhD, Maria Teresa Ferretti, Laura Castro-Aldrete, Dr Antonella Santuccione Chadha 🤝 Support our research in advancing brain and mental health : https://lnkd.in/eWsAwhTX #intracranialaneurysm #UIA #sexdifferences #estrogen #menopause #imaging #AI #Womensbrainfoundation

Imagine for a moment to sit for 10 days beside the person you care most. This person is lying on a bed waiting for doctors, who, given the really special case, are thinking IF and how to intervene. In those 10 days, most probably you will be thinking ‘how I can contribute to fix this’ and the only voice you hear in your head is telling you ‘I am useless’. Most probably the majority of us in the circle of his/her full life, despite the training, studies and job, soon or late will face someone close to be affected by though health conditions, which will manifest themselves quick or slow and will put ourself in front of a couple of questions: could I know that? Could I prevent that? Being side to side to someone with potential health conditions, and not only with manifested health conditions, makes each of us being always a care giver of our beloved. This is what happened to me, when a 39 years old girl, my wife, Germana, passed away because an aneurysm of an incredible size. The questions I asked myself were: - As a husband could I detect symptoms that maybe I did not considered as such?’ - Is there sex and gender bias that characterises this health condition? Could be this bias there from a care giver perspective? - How can I make out of this loss something useful to avoid that other people will live my same experience? This is how I was moved to contact Antonella and the Women Brain Project (WBP) team. A Team of volunteers active in creating awareness on sex and gender differentiation in neurological diseases with a special focus at that time on Alzheimer. My questions related to sex and gender differentiation in aneurysm found immediate attention. This is how this paper found its foundations. This is how I could accomplish one of my personal missions: create AWARENESS among all type of people (not only doctors or patients). All of us could have the role of a care giver even in apparently healthy situations. I would like to thank the WBP, now Women's Brain Foundation which enabled this project, and specially the people who took part to build this paper just published. From the deepest part of my soul thank you to Adelaide J. , Joanna Schaafsma , Dr. Risvin Naser , Julie N. , Simona Mellino, PhD , Maria Teresa Ferretti , Laura Castro-Aldrete Dr Antonella Santuccione Chadha

#gendermedicine Please spread the message! 🚑 💓 💉 ❓ Why are significantly more female patients affected by autoimmune diseases than their male counterparts? Why do cardiac disease symptoms differ so greatly between men and women? And why do we observe sex-specific responses to vaccines or immunotherapy? 💡 Understanding how sex and gender influence disease manifestation, progression, and therapeutic response is crucial for advancing personalized medicine, improving clinical outcomes, and achieving gender equity in healthcare. 📆 On November 29th, 2024, our local Network Gendermedicine organises at the Universitätsklinikum Heidelberg (UKHD) a symposium on "Bridging Disciplines – Advancing Sex and Gender-Related Research within Biomedicine" that aims to bring together national and international clinicians and researchers from diverse disciplines (e.g. Carolin Lerchenmüller, Prof. Dr. Ludwig Sabine, MSc., MA, ) to discuss the latest developments in sex- and gender-related biomedical research. The participation is free of charge. The event will be registered at the LÄK Baden-Württemberg to enable acquisition of CME points (Fortbildungspunkte). The event is sponsored by Health + Life Science Alliance 📣 Call for abstract and registration, here:

#NEW from #AAN2024 | Defining special populations in #headache #medicine 🎥 🧠 Larry Charleston IV, MD, MSc, FAHS, from Michigan State University College of Human Medicine, proposes a definition for special populations in #headachemedicine utilizing frameworks from other services such as the Centers for Medicare & Medicaid Services (CMS) and the Agency for Healthcare Research and Quality (AHRQ) 🔦 The working definition includes populations in the US with #headache disease who experience increased barriers to #healthcareequity in their care or outcomes of their #headachedisease, compared to the general population 🇺🇸 It also covers populations who are underrepresented in headache disease #research. Prof. Charleston IV discusses some proposed groups of special populations in headache medicine, some of which include: African Americans, American Indians, Latin or Hispanic individuals, children, the elderly, homeless individuals, LGBTQ+ individuals, refugees, and pregnant women💡 Find out more 👉 https://lnkd.in/eAdW5gvH #VJNeurology #Neurology #Neurologynews