Tag: Heart

  • Drug-coated balloon shows superiority in coronary in-stent restenosis treatment

    Drug-coated balloon shows superiority in coronary in-stent restenosis treatment

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    In the largest randomized clinical trial and first of its kind to date in the United States, a team led by investigators at Beth Israel Deaconess Medical Center (BIDMC) assessed the efficacy and safety of using a drug-coated balloon in patients undergoing coronary angioplasty. In an original investigation presented at the Cardiology Research Technology conference in Washington, D.C. and published simultaneously in JAMA, the team reports that patients treated with a balloon coated with paclitaxel, a drug to prevent restenosis, experienced lower rates of failure compared with patients treated with an uncoated balloon.

    The findings of the trial-;which was designed and conducted in consultation with the U.S. Food and Drug Administration (FDA) and funded by Boston Scientific Corp.-;suggest that the drug-coated balloon offers an effective treatment strategy for the management of coronary in-stent restenosis, or blockages recurring within previously placed stents. On March 1, the FDA approved the paclitaxel-coated balloon evaluated by the BIDMC-led team, representing the first such balloon to be approved for the treatment of coronary disease in the United States.

    Drug-coated balloons have emerged internationally as an alternative treatment option, but despite promising international data, they have not been previously evaluated or approved for use in the United States. Even with advances in stent technology, patients with coronary in-stent restenosis continue to comprise approximately 10 percent of individuals undergoing angioplasty interventions each year. In particular, patients with multiple prior stents have very poor long-term outcomes. There’s growing sentiment that drug-coated balloons could address an unmet clinical need among patients with coronary artery disease in the United States.”


    Robert W. Yeh, MD, MSc, MBA, lead investigator, director of the Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology and section chief of Interventional Cardiology at BIDMC

    Each year, millions of people around the world undergo coronary angioplasty, a non-surgical intervention to treat blockages in the arteries that supply blood to the heart. In one variation of the procedure known as balloon angioplasty, a deflated balloon attached to a catheter is inserted into a narrowed artery. Once in position, the balloon is inflated, opening up the narrowed blood vessel and restoring blood flow to the heart. While balloon angioplasty is highly effective, five to ten percent of patients experience in-stent restenosis-;a re-narrowing of the treated artery and recurrence of symptoms that requires additional repair-;within a year of the procedure.

    The multicenter randomized trial, known as AGENT IDE, enrolled participants with in-stent restenosis, all of whom had high rates of coronary risk factors; more than half had diabetes and nearly 80 percent previously had two or more major coronary arteries partially or completely blocked. Among the 600 enrollees, 406 were randomized to receive the paclitaxel-coated balloon catheter and194 to receive an uncoated balloon catheter. Clinical follow-up was performed in hospital at 30 days, six months and 12 months following the procedure and will continue through five years.

    Participants were monitored for three primary endpoints: a relapse necessitating revascularization, or another procedure to restore blood flow in the blocked artery; myocardial infarction, or a heart attack caused by lack of blood flow to the heart; and sudden cardiac death.

    At one year out, Yeh and colleagues demonstrated that the drug-coated ballon was superior to an uncoated balloon with respect to the likelihood of patients experiencing one or more of these endpoints. Eighteen percent of participants in the experimental group experienced one or more of the primary endpoints, versus 29 percent in the control group. Similarly, those who received the drug-coated balloon were statistically significantly less likely to require revascularization (13 percent versus 25 percent) or have a myocardial infarction (6 percent versus 11) than those who received an uncoated balloon. The scientists saw no statistically significant difference in the rates of cardiac death between the two groups (3 percent versus 1.6 percent).

    “The participants in this trial represented a patient group at very high risk for recurrent restenosis,” said Yeh, who is also the Katz Silver Family Professor of Medicine in the Field of Outcomes Research in Cardiology at Harvard Medical School. “More than 40 percent of participants had multiple prior stents. Nevertheless, treatment with the drug-coated balloon had a consistent relative risk reduction and numerically greater absolute risk reduction in events. A drug-coated balloon may be particularly useful in the setting where additional stenting would result in three or more layers of stent which would limit future therapeutic options.”

    Co-authors included Richard Schlofmiz, MD, of Saint Francis Hospital; Jeffrey Moses, MD, and Ajay J. Kirtane, MD, SM, of Columbia University Irving Medical Center/New York Presbyterian Hospital and the Cardiovascular Research Foundation; William Bachinsky, MD, of University of Pittsburgh Medical Center; Suhail Dohad, MD, of Cedars Sinai Medical Center; Steven Rudick, MD, of Lindner Center for Research and Education at Christ Hospital; Robert Stoler, MD, at Baylor Scott & White Heart and Vascular Hospital; Brian K. Jefferson, MD, at HCA Tristar Centennial Medical Center; William Nicholson, MD, at Emory University Hospital; John Altman, MD, at Saint Anthony Hospital; Cinthia Bateman, MD, at South Denver Cardiology; Amar Krishnaswamy, MD, at Cleveland Clinic Foundation; J. Aaron Grantham, MD, at Saint Lukes Hospital of Kansas City; Frank J. Zidar, MD, at Austin Hart; Steven P. Marso, MD, at Overland Park Regional Medical Center; Jennifer A. Tremmel, MD, MS, at Stanford University Medical Center; Cindy Grines at Northside Hospital Cardiovascular Institute; Mustafa I. Ahmed, MD, at University of Alabama at Birmingham; Azeem Latib, MD, at Montefiore Medical Center Albert Einstein College of Medicine; Benham Tehrani, MD, and Wayne Batchelor, MD, at the Innova Schar Heart and Vascular Institute; J. Dawn Abbott, MD, at Lifespan Cardiovascular Institute, Rhode Island Hospital; Paul Underwood, MD, and Dominic J. Allocco, MD, Boston Scientific Corporation. This study was supported by Boston Scientific Corp. Quantitative coronary angiography was conducted by Baim Institute for Clinical Research, Inc, an independent angiographic core laboratory.

    Yeh reported receiving personal fees and grants from Boston Scientific during the conduct of this study; as well as grants and personal fees from Boston Scientific, Abbott, Vascular and Medtronic, and personal fees from the US Food and Drug Administration, Elixir Medical, Shockwave Medical and infrared X outside the submitted work. 

    Source:

    Journal reference:

    Yeh, R. W., et al. (2024). Paclitaxel-Coated Balloon vs Uncoated Balloon for Coronary In-Stent Restenosis: The AGENT IDE Randomized Clinical Trial. JAMA. doi.org/10.1001/jama.2024.1361.

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  • Immune cells in the liver eat up excess cholesterol, study reveals

    Immune cells in the liver eat up excess cholesterol, study reveals

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    A new study from Karolinska Institutet in Sweden reveals that immune cells in the liver react to high cholesterol levels and eat up excess cholesterol that can otherwise cause damage to arteries. The findings, published in Nature Cardiovascular Research, suggest that the response to the onset of atherosclerosis begins in the liver.

    Cholesterol is a type of fat that is essential for many functions in the body, such as making hormones and cell membranes. However, too much cholesterol in the blood can be harmful, as it can stick to the walls of the arteries and form plaques that narrow or block the blood flow. This results in atherosclerotic cardiovascular disease, the primary underlying cause of heart attacks and strokes, and the leading cause of death worldwide.

    The liver responded immediately

    In the current study, researchers wanted to understand how different tissues in the body react to high levels of LDL, also called ‘bad cholesterol’, in the blood. To test this, they created a system where they could quickly increase the cholesterol in the blood of mice.

    Essentially, we wanted to detonate a cholesterol bomb and see what happened next. We found that the liver responded almost immediately and removed some of the excess cholesterol.”

    Stephen Malin, lead author of the study and principal researcher at the Department of Medicine, Solna, Karolinska Institutet

    However, it wasn’t the typical liver cells that responded, but a type of immune cell called Kupffer cells that are known for recognizing foreign or harmful substances and eating them up. The discovery made in mice was also validated in human tissue samples.

    “We were surprised to see that the liver seems to be the first line of defense against excess cholesterol and that the Kupffer cells were the ones doing the job,” says Stephen Malin. “This shows that the liver immune system is an active player in regulating cholesterol levels, and suggests that atherosclerosis is a systemic disease that affects multiple organs and not just the arteries.”

    Several organs could be involved

    The researchers hope that by understanding how the liver and other tissues communicate with each other after being exposed to high cholesterol, they can find new ways to prevent or treat cardiovascular and liver diseases.

    “Our next step is to look at how other organs respond to excess cholesterol, and how they interact with the liver and the blood vessels in atherosclerosis,” says Stephen Malin. “This could help us develop more holistic and effective strategies to combat this common and deadly disease.”

    The research was supported by grants from the Swedish Heart-Lung Foundation, Leducq Foundation Networks of Excellence Program B cells in Cardiovascular Disease, EU’s Seventh Framework Program FP7, The Swedish Research Council and the Marie Skłodowska-Curie Actions Award. 

    Source:

    Journal reference:

    Di Nunzio, G., et al. (2024). Kupffer cells dictate hepatic responses to the atherogenic dyslipidemic insult. Nature Cardiovascular Research. doi.org/10.1038/s44161-024-00448-6.

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  • Scripps Research tests wearable devices as relief for long COVID symptoms

    Scripps Research tests wearable devices as relief for long COVID symptoms

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    Scientists at the Scripps Research Digital Trials Center have partnered with the health technology company CareEvolution to launch a remote study that will investigate whether wrist-worn devices, such as activity trackers and smartwatches, can help people with long COVID manage and reduce the severity of their symptoms.

    New treatments and interventions are urgently needed. We’re excited to launch the Long COVID Wearable Study and apply our team’s expertise in sensor technologies and digital trials to collecting robust data on how activity trackers might provide some patients with much needed relief. While symptom management will not remove the root cause of long COVID, we hope to validate the patient community’s experience that pacing is currently one of the best ways to reduce symptom severity, and wearable devices can help implement pacing.”


    Julia Moore Vogel, PhD, study principal investigator 

    Even as COVID-19 precautions end, long COVID continues to exact a heavy toll on millions of people worldwide. An estimated 65 million individuals have long COVID and there are currently no broadly effective treatments. The illness consists of a collection of symptoms that develop and continue after a COVID-19 infection. It can affect multiple organ systems of the body including respiratory, cardiovascular, neurological, musculoskeletal and immunological, with symptoms varying from person to person. For many, long COVID has a profound and debilitating impact on daily life.

    Researchers have observed significant overlap between long COVID and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), with many patients struggling with post-exertional malaise-;a worsening of symptoms after even minor physical, mental or emotional exertion. Many also suffer from Postural Orthostatic Tachycardia Syndrome (POTS)-;an increase in heart rate when a person stands up or walks, causing dizziness and heart palpitations. For both conditions, patients have reported that monitoring levels of energy expenditure has helped them improve symptom management. This exercise, known as pacing, allows patients to identify their own quantitative thresholds to help avoid symptom exacerbation.

    Trackers that collect a range of metrics-;including heart rate, heart rate variability, physical activity, sleep patterns and stress levels-;have been shown to be helpful tools for capturing and monitoring a person’s physiological state throughout the day. The Long COVID Wearable Study will allow scientists to analyze sensor data from participants coupled with data related to diagnoses, symptoms and quality of life collected via surveys. The goal of the study is to determine if long COVID, ME/CFS, and POTS patients who wear wrist-worn activity trackers and who receive educational materials on pacing see a decrease in symptom severity and whether this differs by device brand.

    To conduct the trial, Vogel and colleagues partnered with CareEvolution, the company behind the MyDataHelps digital clinical trial platform. Participants can enroll, complete electronic consent, answer surveys and communicate with study coordinators via a mobile or web app, making it possible for people to participate remotely, without the need to visit a clinic.

    “The ubiquity of smartphones is driving a new era in research where traditional barriers for participation are being removed,” says Vik Kheterpal, MD, principal at CareEvolution. “The long COVID community is a perfect example of a patient group that can benefit from a digital trial experience, which enables participation from home, at your own pace.” 

    While participants can use their own activity tracker or smartwatch to take part, the study team will also be distributing 500 Garmin wearables to an eligible subset of participants who do not own a device.

    For more details about the Long COVID Wearable Study including how to participate, visit longcovid.scripps.edu.

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  • Study highlights areas where diabetics need more education

    Study highlights areas where diabetics need more education

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    The body’s inability to produce enough insulin or use it effectively often results in type 2 diabetes (T2D), a chronic disease affecting hundreds of millions of people around the globe. Disease management is crucial to avoid negative long-term outcomes, such as limb amputation or heart disease. To counteract adverse consequences, it is crucial that patients have good knowledge about the day-to-day management of the disease. 

    A team of researchers in Portugal has now assessed how many patients – both insulin-treated and not insulin-treated – have this crucial knowledge about T2D. They published their findings in Frontiers in Public Health.

    “Our main motivation was to contribute to the reduction of the existing disparity in the knowledge that diabetic patients have regarding their disease,” said first author Prof Pedro Lopes Ferreira, director of the Center for Health Studies and Research of the University of Coimbra. “With this study we evidenced the need to improve the disease knowledge of type 2 diabetic patients.”

    Knowledge levels vary widely

    To assess diabetes knowledge, the researchers used a knowledge test developed for people with type 1 or type 2 diabetes. Among other questions, the test includes sections about nutrition, signs and symptoms, and medication control. 1,200 people with diabetes participated in the study, of whom almost 40% were insulin-treated. The rest of the sample adhered to specific diets with some of them additionally taking non-insulin oral antidiabetics, while others relied on diet alone.

    The results showed that many participants (71.3%) could answer food-related questions correctly, and that more than four out of five respondents demonstrated good knowledge of the positive impact of physical activity. More than 75% of respondents also knew about the best method for testing blood sugar levels.

    In other areas, however, the researchers found that knowledge was severely lacking. For example, when asked which food item should not be used to treat low blood sugar levels, only 12.8% of participants answered correctly. The lowest percentage (4.4%) of correct answers was on a question concerning the symptoms of ketoacidosis, a potentially life-threatening, late-stage T2D complication.

     One of the main reasons for this disparity in knowledge is probably the behavior of health professionals and the areas that are prioritized when informing patients.”


    Pedro Lopes Ferreira, Director, Center for Health Studies and Research, University of Coimbra

    Equipping patients with knowledge

    The researchers found that the use of medication was one factor that impacted T2D knowledge. The percentage of correct answers was 51.8% for non-insulin treated patients, and 58.7% for patients using insulin. Looking at socioeconomic and demographic factors, being younger than 65 years, having a higher education, not living alone, and following a specific diet had a positive impact on disease knowledge.

    The researchers said that their results highlight the need to improve T2D knowledge about certain aspects of the disease, for example blood sugar monitoring, which can help to avoid spikes in blood sugar levels that are associated with acute and chronic complications. Knowledge gaps within individual sections of the test are also something that needs to be addressed urgently, the team pointed out.

    They also stated that studies with even more participants could help to better understand the role of the socioeconomic and clinical determinants of the disease. “We focused on patients’ own knowledge of their disease, rather than disease management being based solely on biological indicators. We hope that the results obtained will allow professionals to change the way they inform patients,” Lopes Ferreira concluded.

    Source:

    Journal reference:

    Ferreira, E. L., et al. (2024) Many type 2 diabetes patients lack potentially life-saving knowledge about their disease. Frontiers in Public Healthdoi.org/10.3389/fpubh.2024.1328001.

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  • How Hologic is Shaping the Future of Women’s Healthcare

    How Hologic is Shaping the Future of Women’s Healthcare

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    In celebration of International Women’s Day 2024, we’re honored to host Tim Simpson and Sarah Smith from Hologic, a forefront leader in women’s health. As we dive into this year’s theme, “Invest in Women: Accelerate Progress” and “#InspireInclusion,” let’s explore how Hologic’s pioneering work and dedication align with these powerful calls to action.

    Join us as we discuss the crucial role of investment in women’s healthcare and the innovative strides Hologic is making toward inclusive and progressive healthcare solutions.

    Firstly, please introduce yourself and Hologic. More specifically, how does Hologic’s mission align with the 2024 International Women’s Day theme of “Invest in Women: Accelerate Progress” and ”#Inspireinclusion”?

    Tim: I’m Tim Simpson, General Manager UK & Ireland at Hologic. Hologic is a global champion of women’s health, providing innovations designed to detect, diagnose, and treat women’s health conditions. We see it as our mission to advance women’s health, and for this to happen in the UK, targeted investments in research and technology are crucial.

    Sarah: I’m Sarah Smith, Senior Marketing Manager, Surgical Gynaecology, EMEA. Improvement in women’s healthcare only begins when there is investment in empowering women to feel confident to know when to talk to a healthcare professional (HCP) about their health concerns. By the same token, we also need to invest in educating HCPs so that when a woman speaks to their GP, they leave feeling heard and understood.

    Learn more about Hologic

    From your perspective, why is putting women at the heart of decision-making critical in advancing women’s healthcare?

    Sarah: Putting women at the heart of all decisions is the cornerstone of patient-centered care. Shared decision-making is needed to ensure that the patient and clinician work together to make the best healthcare decision for the individual.

    In women’s health, it is particularly important to champion shared decision-making. High rates of misdiagnosis, myths, and misperceptions about conditions1,2, as well as barriers to dialogue due to the sensitive nature of some conditions, can often leave women in the dark when it comes to decisions about their health and treatment.2

    Providing women with better education via initiatives, such as our Wear White Again awareness campaign for women suffering from Heavy Menstrual Bleeding, is vital in empowering them to seek help.

    Improved education and knowledge can make a considerable difference, especially in situations where dialogue barriers may prevent women from clearly communicating their condition’s impact on their lives. Equally, providing clinicians with relevant and up-to-date information is crucial so that when women present symptoms, the conversations between them and their clinicians are productive and satisfactory for both parties.

    In the context of reducing health inequalities, what are some of the barriers to accessing quality healthcare for women, and how is Hologic working to overcome these challenges?

    Tim: We know from our annual Hologic Global Women’s Health Index that cancer testing amongst women has improved. However, our supplementary research found that women from ethnic minorities (non-white women) reported lower attendance for breast cancer screening (11% vs. 25%), compared with white women.”3,4 It is concerning to see these discrepancies, as we know cancer can affect anyone.

    One of the main barriers to attending screenings is being time-poor, with another being not having access to the correct health information. We know it’s vital that health information is accessible for all and translated into multiple languages.

    To tackle these inequalities, we must work in partnership with different organizations, for example, charities that hold vital insights into women’s experiences, to better understand how we make breast cancer screening accessible for all.

    In 2021, we partnered with Manchester-based charity, Prevent Breast Cancer for our global Project Health Equality Campaign, which engaged with hundreds of women to raise awareness of breast cancer and the importance of attending their screening.

    Both breast and cervical cancer remain a significant concern worldwide. Could you discuss the efficiencies Hologic is implementing to help reduce the incidence of these common cancers?

    Tim: We believe diagnostic innovation is key to helping detect cancers early, therefore improving the chances of a better outcome. Both cervical and breast cancer screening are well suited for digital technologies and the application of artificial intelligence (AI), given both require highly trained medical professionals to identify rare, subtle changes visually. This process can be labor-intensive and time-consuming. AI and computer vision are technologies that could help to improve this significantly.

    AI and increased screening units and mammographers can potentially increase breast cancer screening capacity by removing the need for review by two radiologists5.

    When AI-guided imaging is used as part of a screening program, it could effectively and efficiently highlight the areas that are of particular interest to the reader, in the case of breast screening or cytotechnologists, when considering cervical screening.

    Additionally, AI can be used for risk stratification, meaning it could help identify women who are particularly at risk and push them further up the queue for regular screening.

    For example, women with dense breast tissue have a greater risk factor than having two immediate family members who have suffered from breast cancer. What is more, dense breasts make it more difficult to identify cancerous cells in standard mammograms6. This means that in some cases, cancers may be missed, and in others, women will be unnecessarily recalled for further investigation. 

    Could you discuss the advancements in diagnosing and treating heavy menstrual bleeding and how these impact women’s lives?

    Sarah: Our research conducted in 2022 found that only a quarter of those who reported symptoms of heavy menstrual bleeding (HMB) (24%) have received a formal diagnosis. Perhaps even more concerning is that nearly half of the women who experience symptoms of the condition (42%) have not spoken to their GP about them, demonstrating a potential belief that it is something to be endured rather than managed7.

    GPs cannot be experts in every area, and as they continue to do more with limited resources, it is vital to ensure that primary care is supported to understand HMB better. This is a point echoed by the Women’s Health Strategy, which has the ambition of healthcare professionals in primary care to be well-informed and trained in menstrual and gynecological health8.

    Alongside this research, Hologic has launched a report entitled, ‘The right patients, the right setting, the right clinicians’ to set out its vision on tackling HMB. The report recommends launching Women’s Health Hubs and the development of a specific Office for Health Improvement and Disparities communication campaign to support clinicians with building a greater knowledge of menstrual conditions, so GPs can effectively recognise and diagnose HMB.

    How does Hologic’s approach to women’s health care exemplify innovation in addressing long-standing health issues like endometriosis and menstrual health?

    Sarah: Part of our approach at Hologic when championing women’s healthcare is to make sure we connect with key stakeholders along the patient pathway, as we know we need to work collaboratively to change the status quo. This attitude is reflected in our everyday lives – I spend much of my time speaking to clinicians and patients to understand better the challenges they face and the solutions we can collectively create.

    This was the approach we took when conducting the heavy menstrual bleeding roundtable. We made sure we had a diverse set of menstrual health experts who could speak to different parts of the patient pathway. We were also honored to be joined by Dame Lesley Regan, the first Women’s Health Ambassador for England.

    As mentioned, we produced the report following the inspiring roundtable discussion. It is available on our Hologic UK website.  

    Image Credit: fizkes/Shutterstock.comImage Credit: fizkes/Shutterstock.com

    How does Hologic UK & Ireland measure the impact of its initiatives on women’s health, and what benchmarks do you use to evaluate success in contributing to the broader goals of healthcare equity and access?

    Tim: At Hologic, we believe you cannot improve what you don’t measure, so we must continue to collect vital data to help us pinpoint how we best support women across the country.

    In 2021, we launched the Hologic Global Women’s Health Index (HGWHI)*, a globally comparative study in partnership with Gallup, to measure and monitor the behaviors and attitudes influencing women’s access to quality healthcare. It provides us with a unique insight into the experiences of women across the globe, including the UK. HGWHI runs annually; we’re launching the UK data in May.

    Our ambition is that the HGWHI results, in partnership with research from key organizations, will help to form a quality data set that can be used as a benchmark for how UK women perceive their health in the years to come.

    ​As leaders in the healthcare industry, how do you foresee the role of technology evolving to further support women’s health initiatives in the next decade?

    Tim: We know that preventing disease saves lives9. Therefore, as a business leader, I believe technology should lie at the heart of prevention, detection, and diagnosis. Technology for breast cancer screening is an area where investment is crucial to meet women’s health needs in preventative health.

    Currently, many screening programs use traditional 2D mammography technology, which makes identifying cancer lesions more difficult in dense breasts. Therefore, investing in technology such as tomosynthesis (3D Mammography) for breast cancer screening would help provide the reassurance that women deserve. Tomosynthesis detects up to 65% more invasive breast cancers when compared to traditional 2D Mammography alone10.**

    The second method of improving breast and cervical cancer screening programs is using artificial intelligence (AI) to support reading images. Therefore, investing in digital infrastructure is crucial to improving the accuracy and efficiency of diagnosis, as it will ultimately lead to earlier treatment and, thus, better patient outcomes.

    Endometriosis Month coincides with International Women’s Day. How is Hologic raising awareness and advancing treatment options for this often-overlooked condition?

    Sarah: This year’s Endometriosis Month theme is, ‘Could it be endometriosis?’ which makes me think about all the undiagnosed women and girls living in pain. At Hologic, we prioritize fostering relationships with stakeholders and policymakers to raise awareness of what is needed to improve women’s health and the importance of treating gynecological health.  

    As previously mentioned, the HMB roundtable with Dame Lesley Regan, the first Women’s Health Ambassador for England, and other influential leaders from across the continuum of menstrual health care to discuss how we can improve patient pathways for heavy menstrual bleeding was a recent example.

    Additionally, we recognize the importance of data to understand women’s conditions and care and, therefore, conducted research in 2022. This data collected provided the below insights on pain 4:

    • Nearly a quarter of women in the UK experience pain daily, and a fifth of those have had to stop working because of their pain.
    • Among these respondents, the top causes were joint pain, backache, and headache. Women also reported pain due to periods, menopause, heavy menstrual bleeding, and endometriosis.
    • It takes women, on average, 4.29 visits with a healthcare professional before being diagnosed with the cause of their pain, with just more than a quarter of women still not having a diagnosis.

    At Hologic, we believe that to achieve improvement in the treatment of women’s pain is two-fold. We need to continue to educate healthcare professionals (HCPs), so they are provided with the most up-to-date information to diagnose menstrual conditions effectively.

    We also need to ensure that HCPs know that diagnosis and treatment can be overwhelming for the patient and allow time to support patients through the process, setting clear expectations to avoid disappointment post-treatment.

    Can you share a success story or case study where Hologic’s initiatives directly impact women’s healthcare outcomes?

    Tim: We’ve seen first-hand the positive impact AI-guided imaging can directly have on women’s healthcare outcomes. An example of this would be the UK’s first pilot of digital cytology in cervical cancer screening at University Hospital Monklands.

    The technology rapidly reviews test slides, providing the screener with the most diagnostically relevant cells. The initial results are promising, with the hospital reporting increased capacity in slide assessment and improved analysis turnaround times.

    Allan Wilson, Consultant Biomedical Scientist at NHS Lanarkshire, who led the pilot project, commented on the possibilities of the technology in allowing screeners to dedicate more time to training on the latest technologies and dealing with difficult-to-diagnose cases.

    He also noted that with advanced technology, giving women their results quicker increases their confidence in cervical cancer screening while reducing the likelihood of a false negative so any pre-cancerous changes can be picked up and treated earlier before they become cancerous.​​​​​​

    How does Hologic ensure that women’s voices and experiences are incorporated into the development and improvement of gynaecological surgical solutions?

    Sarah: At Hologic, we work extremely closely with patient groups and women’s charities to better understand the patient’s voice. They hold key knowledge and insights about the patient’s experience.

    At the Heavy Menstrual Bleeding Roundtable that I referenced earlier, we brought together experts from different parts of the patient pathway to ensure that women’s experiences were an integral part of the discussion. This meant that their views shaped the resulting report. helped ensure that we were able to understand a woman’s experience. This, in turn, helps us to improve our services and solutions.

    Looking towards the future, what are the main areas of women’s health that Hologic is focusing on for research and development?

    Tim: Hologic is passionate about delivering solutions that are based on data-driven insights that improve women’s well-being. As we look ahead to the future, we will continue to invest in developing our solutions and services that enable healthcare professionals to provide better healthcare to women.

    We also remain committed to raising awareness of the need to address the inequities in women’s health and educating women so they can better advocate for themselves.

    Where can readers find more information?

    About Tim Simpson

    Tim Simpson General Manager at Hologic, UK and Ireland. Tim joined Hologic in 2019 as UK Country Business Manager, before becoming Hologic UK and Ireland’s General Manager in February 2022.

    About Sarah Smith

    Sarah Smith, Senior Marketing Manager, Gynaecology Surgical EMEA. Sarah has worked at Hologic for over twenty years, beginning her role as Senior Marketing Manager EMEA in 2023.​

     

    Sources:

    1. Better for Women. Royal College of Obstetricians and Gynaecologists. 2019. Available from: https://www.rcog.org.uk/about-us/campaigning-and-opinions/better-for-women/ [Accessed 15 February 2024]
    2. Thompson J and Blake D. Women’s Experiences of Medical Miss-Diagnosis: How Does Gender Matter in Healthcare Settings?”. Women’s Studies Journal 2020; 34:28.
    3. Hologic. Hologic Global Women’s Health Index. 2021
    4. OnePoll. Women’s Health Index. 2022
    5. American Cancer Society [Internet]. Breast Cancer Facts & Figures 2019-2020 Available from: https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/breast-cancer-facts-and-figures/breast-cancer-facts-and-figures-2019-2020.pdf [Accessed 15 February 2024]
    6. National Cancer Institute. Dense Breast: Answers to Commonly Asked Questions. Available from: https://www.cancer.gov/types/breast/breast-changes/dense breasts#:~:text=Dense%20breasts%20can%20make%20a,tissue%20appears%20as%20dark%20areas [Accessed 15 February 2024]
    7. Hologic data on file MISC-08708-GBR-EN . Survey of 2,000 Women aged 18-55 plus top up 1,000 UK women who have heavy menstrual bleeding during October 20th – 27th 2022.
    8. Department of Health and Social Care. Women’s Health Strategy for England. Available from https://www.gov.uk/government/publications/womens-health-strategy-for-england/womens-health-strategy-for-england [Accessed 15 February 2024]​​​​​​
    9. Department of Health & Social Care. [Internet] Prevention is better than cure. 2018. [Accessed 14 February 2024] Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/753688/Prevention_is_better_than_cure_5-11.pdf
    10. Friedewald SM, Rafferty EA, Rose SL, Durand MA, Plecha DM, Greenberg JS, et al. Breast cancer screening using tomosynthesis in combination with digital mammography. JAMA, 2014 Jun 25;311(24):2499-507.

    *The Hologic Global Women’s Health Index is one of the most comprehensive initiatives measuring the state of health for 97% of the world’s women and girls aged 15 and older.

    **Results from Friedewald, SM, et al. “Breast cancer screening using tomosynthesis in combination with digital mammography.” JAMA 311.24 (2014): 2499-2507; a multi-site (13), non-randomized, historical control study of 454,000 screening mammograms investigating the initial impact the introduction of the Hologic Selenia® Dimensions ® on screening outcomes. Individual results may vary. The study found an average 41% (95% CI: 20-65%) increase and that 1.2 (95% CI: 0.8-1.6) additional invasive breast cancers per 1000 screening exams were found in women receiving combined 2D FFDM and 3D™ mammograms acquired with the Hologic 3D Mammography™ System versus women receiving 2D FFDM mammograms only.

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  • Pregnant women with autoimmune conditions at a greater risk of developing adverse pregnancy outcomes, study suggests

    Pregnant women with autoimmune conditions at a greater risk of developing adverse pregnancy outcomes, study suggests

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    In a recent review published in BMC Medicine, researchers analyzed systematic reviews conducted on the association between autoimmune diseases and pregnancy outcomes.

    Study: Autoimmune diseases and adverse pregnancy outcomes: an umbrella review. Image Credit: Africa Studio/Shutterstock.com
    Study: Autoimmune diseases and adverse pregnancy outcomes: an umbrella review. Image Credit: Africa Studio/Shutterstock.com

    Background

    Autoimmune diseases, particularly in women, have been associated with poor pregnancy outcomes as a result of environmental variables such as lifestyle changes, dietary changes, and exposure to certain infections and medicines. The unfavorable pregnancy outcomes associated with certain autoimmune disorders might improve, worsen, or remain constant during pregnancy.

    Autoimmune diseases can complicate pregnancy by enabling antibodies generated by the mother to infiltrate the fetal system, affecting the development of the fetal heart. Clinical management of autoimmune pregnancies necessitates multidisciplinary care and an appreciation of the risk of adverse pregnancy outcomes.

    About the review

    In the present review, researchers analyzed the impact of autoimmune disease prevalence on pregnancy outcomes, using systematic reviews to identify the strength and precision of these associations.

    The team searched the Cochrane Medline and Embase databases from inception through December 15, 2023, without language restrictions for systematic reviews evaluating the association between autoimmune disorders and pregnancy outcomes. They excluded systematic reviews, including those involving women conceiving through assisted reproduction therapy and those evaluating the relationship between drugs for autoimmune diseases and pregnancy outcomes. They also excluded literature reviews, scoping reviews, conference abstracts, and protocols.

    The researchers used the Joanna Briggs Institute (JBI) framework, following the Preferred Reporting Items for Overviews of Reviews (PRIOR) checklist. Two researchers independently performed data screening and extraction and appraised the identified records using the Assessment of Multiple Systematic Reviews Version 2 (AMSTAR 2) tool, consulting a third researcher to resolve discrepancies.

    The team evaluated systematic review quality using the Newcastle-Ottawa scale (NOS). They synthesized data quantitatively to estimate relative risks (RRs) and odds ratios (ORs) and performed random effect modeling for meta-analysis to obtain pooled effect estimates.

    Autoimmune disorders included celiac disease, inflammatory bowel disease (IBD), including ulcerative colitis and Crohn’s disease, psoriatic disorders (psoriasis and psoriatic arthritis), Sjögren’s syndrome, rheumatoid arthritis, systemic sclerosis, systemic lupus erythematosus (SLE), thyroid autoimmunity (Hashimoto’s thyroiditis and Grave’s disease), vitiligo, and type 1 diabetes mellitus (T1DM).

    Results

    Initially, the team identified 2,743 records, of which 2,351 underwent title-abstract screening and 92 underwent full-text screening after duplicate removal. As a result, they analyzed 32 records, including 709 primary studies, most of which were of moderate-high quality. They found a significant ectopic pregnancy risk among IBD patients (OR, 1.3), with similar risks for ulcerative colitis and Crohn’s disease.

    The team found increased miscarriage risk among females with systemic lupus erythematosus (OR, 4.9) and Sjögren’s syndrome (RR, 8.9), with the risk being higher (OR, 2.8) in the case of thyroid autoimmune conditions. Miscarriage risk was also significantly higher among women with celiac disease, rheumatoid arthritis, systemic sclerosis, and psoriasis, with OR values of 1.4, 1.3, 1.6, and 1.1, respectively. Female celiac disease patients had a significantly higher risk of recurrent gestational losses (OR, 5.8), exacerbated in thyroid autoimmunity presence (OR, 1.9).

    Gestational hypertension odds were higher among females with T1DM, psoriasis, and psoriatic arthritis, with OR values of 2.7, 1.3, and 1.5, respectively, enhanced by thyroid autoimmunity (OR, 1.3). The team found higher pre-eclampsia prevalence among females with type 1 diabetes mellitus (OR, 4.2), systemic lupus erythematosus (OR, 3.2), and systemic sclerosis or scleroderma (OR, 2.2). Women with IBD were at an increased risk of gestational diabetes (OR, 3.0). Cesarean section delivery was associated with T1DM (OR, 4.0) and SLE (OR, 2.1). Women with thyroid autoimmune disorders had higher odds of postpartum depression (OR, 2.0).

    Women with systemic sclerosis and celiac disease were at a higher risk of intrauterine growth restriction (IUGR), with OR values of 3.2 and 1.7, respectively. The OR values for small for gestational age (SGA) babies were 2.5 for SLE, 1.5 for rheumatoid arthritis, and 0.7 for T1DM patients. The OR values for stillbirth among women with SLE, T1DM, rheumatoid arthritis, celiac disease, and IBD were 17, 4.0, 2.0, 2.0, and 1.6, respectively.

    The team noted a higher risk for preterm birth among women with T1DM (OR, 4.4), systemic lupus erythematosus (OR, 2.8), systemic sclerosis (OR, 2.4), Sjögren’s syndrome (RR, 2.3), inflammatory bowel disease (OR, 1.8), rheumatoid arthritis (OR, 1.6), psoriatic arthritis (OR, 1.5), celiac disease (OR, 1.3), and psoriasis (OR, 1.2). They reported low-birth-weight babies among women with SLE (OR, 6.0) and systemic sclerosis (OR, 3.8). Neonatal mortality was associated with SLE (OR, 8.3), T1DM (OR, 2.3), and Sjögren’s syndrome (OR, 1.8).

    Conclusion

    Overall, the review findings showed that women with autoimmune disorders are at a high risk of unfavorable pregnancy outcomes. However, further research is required to develop more evidence-based, standardized recommendations and assist physicians and women in making educated decisions about treating these diseases before and throughout pregnancy.

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  • Is there a higher risk of depression among specific populations of patients with rheumatoid arthritis?

    Is there a higher risk of depression among specific populations of patients with rheumatoid arthritis?

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    In a recent study published in JAMA Network Open, researchers assessed the risk of depression following the diagnosis of rheumatoid arthritis (RA).

    Study: Rheumatoid Arthritis and Risk of Depression in South Korea. Image Credit: Africa Studio/Shutterstock.com
    Study: Rheumatoid Arthritis and Risk of Depression in South Korea. Image Credit: Africa Studio/Shutterstock.com

    RA, a prevalent autoimmune disease, is characterized by systemic inflammation. The chronic nature of the disease necessitates lifelong treatment, often leading to comorbidities, including depression. Depression is highly prevalent among RA patients compared to the general population and has been associated with increased disease activity, pain exacerbation, elevated risk of myocardial infarction, less frequent remission, poor health-related quality of life, and higher health care utilization. Therefore, depression management and prevention are essential to improving the health and quality of life of RA patients.

    About the study

    In the present study, researchers examined associations of RA with subsequent depression risk in South Korea. They included subjects diagnosed with RA during 2010-17. Seropositive RA (SPRA) was defined using the International Classification of Diseases, Tenth Revision (ICD-10) codes and enrolment in the Rare and Intractable Diseases (RID) program.

    RID program enrollment for SPRA required a positive test result for anticyclic citrullinated peptide antibodies or rheumatoid factors and a physician report indicating the fulfillment of RA classification criteria. Seronegative RA (SNRA) was defined using ICD-10 codes and prescription of disease-modifying anti-rheumatic drugs (DMARDs) for ≥ 270 days.

    The team excluded subjects if they were aged under 20, had prior depression, missing data, or developed depression within a year post-index date. RA patients were matched to individuals without RA (controls) by sex, age, and index date. The study endpoint was a new diagnosis of depression. Participants were followed up from one year post-RA diagnosis until the diagnosis of depression, death, or December 31, 2019.

    The Kaplan-Meier method was used to estimate the cumulative incidence of depression. Differences between groups were evaluated using log-rank tests. Cox regression analyses estimated adjusted hazard ratios and 95% confidence intervals for the risk of depression. The association between depression risk and the type of DMARDs used was also evaluated.

    Analyses were adjusted for sex, age, smoking/alcohol status, income, body mass index, physical activity, diabetes, chronic kidney disease, hyperlipidemia, and hypertension. Besides, stratified analyses were conducted by sex, age, comorbidities, and health behaviors. Restricted mean survival time (RMST) differences were analyzed between groups by sex and age.

    Findings

    Overall, 230,922 participants aged 54.6, on average, were included for analysis. There were 38,487 RA patients and 192,435 controls; most participants were female (71%). Among RA patients, 11,645 were seronegative, and 26,842 were seropositive. RA patients were more likely to be non-drinkers and less likely to be obese. SPRA patients were more likely to be female, older, non-drinkers, and less likely to be obese than SNRA patients.

    The median follow-up duration was 4.1 years, during which 6,422 RA patients and 20,641 had newly developed depression. RA patients had a higher risk of depression than controls. Moreover, SPRA and SNRA groups had elevated depression risk compared to controls. Among RA patients with depression, 402 were prescribed biological or targeted synthetic DMARDs, and 6,020 were prescribed only conventional synthetic DMARDs.

    Notably, the incidence of depression among RA patients was consistently lower among recipients of targeted synthetic or biological DMARDs than non-recipients. Stratified analyses yielded findings consistent with the primary analysis. RMST differences were variable across age groups, with a higher difference in the ≥ 60-year age group.

    Conclusions

    In sum, the researchers observed a 1.66-fold increased depression risk among RA patients relative to those without RA. There was no significant difference in depression risk by the serologic status of RA, with both SNRA and SPRA groups exhibiting an increased risk. RA patients receiving targeted synthetic or biological DMARDs had lower risks than those who did not. Nevertheless, the study has a few limitations. Notably, disease activity was inaccessible, resulting in limited evaluation of RA severity.

    Moreover, information on depression levels at the index date was not available. Besides, because participation was limited to those undergoing health screening, participants might have been healthier or engaged more in healthy behaviors than the general population.

    Taken together, the findings suggest an increased depression risk among RA patients, irrespective of RA serologic status, age, sex, and behavioral factors, warranting consistent screening of RA patients and comprehensive healthcare to address their physical and mental well-being.

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  • Childhood ‘lazy eye’ linked to increased health risks in adulthood

    Childhood ‘lazy eye’ linked to increased health risks in adulthood

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    Adults who had amblyopia (‘lazy eye’) in childhood are more likely to experience hypertension, obesity, and metabolic syndrome in adulthood, as well as an increased risk of heart attack, finds a new study led by UCL researchers.

    In publishing the study in eClinicalMedicine, the authors stress that while they have identified a correlation, their research does not show a causal relationship between amblyopia and ill health in adulthood.

    The researchers analyzed data from more than 126,000 participants aged 40 to 69 years old from the UK Biobank cohort, who had undergone ocular examination.

    Participants had been asked during recruitment whether they were treated for amblyopia in childhood and whether they still had the condition in adulthood. They were also asked if they had a medical diagnosis of diabetes, high blood pressure, or cardio/cerebrovascular disease (ie. angina, heart attack, stroke).

    Meanwhile, their BMI (body mass index), blood glucose, and cholesterol levels were also measured and mortality was tracked.

    The researchers confirmed that from 3,238 participants who reported having a ‘lazy eye’ as a child, 82.2% had persistent reduced vision in one eye as an adult.

    The findings showed that participants with amblyopia as a child had 29% higher odds of developing diabetes, 25% higher odds of having hypertension and 16% higher odds of having obesity. They were also at increased risk of heart attack – even when other risk factors for these conditions (e.g. other disease, ethnicity and social class) were taken into account.

    This increased risk of health problems was found not only among those whose vision problems persisted, but also to some extent in participants who had had amblyopia as a child and 20/20 vision as an adult, although the correlation was not as strong.

    Corresponding author, Professor Jugnoo Rahi (UCL Great Ormond Street Institute for Child Health, UCL Institute of Ophthalmology and Great Ormond Street Hospital), said: “Amblyopia is an eye condition affecting up to four in 100 children. In the UK, all children are supposed to have vision screening before the age of five, to ensure a prompt diagnosis and relevant ophthalmic treatment.

    “It is rare to have a ‘marker’ in childhood that is associated with increased risk of serious disease in adult life, and also one that is measured and known for every child – because of population screening.

    “The large numbers of affected children and their families, may want to think of our findings as an extra incentive for trying to achieve healthy lifestyles from childhood.”

    Amblyopia is when the vision in one eye does not develop properly and can be triggered by a squint or being long-sighted.

    It is a neurodevelopmental condition that develops when there’s a breakdown in how the brain and the eye work together and the brain can’t process properly the visual signal from the affected eye. As it usually causes reduced vision in one eye only, many children don’t notice anything wrong with their sight and are only diagnosed through the vision test done at four to five years of age.

    A recent report from the Academy of Medical Sciences involving some researchers from the UCL Great Ormond Street Institute for Child Health, called on policymakers to address the declining physical and mental health of children under five in the UK and prioritize child health.

    The team hopes that their new research will help reinforce this message and highlight how child health lays the foundations for adult health.

    Vision and the eyes are sentinels for overall health – whether heart disease or metabolic dysfunction, they are intimately linked with other organ systems. This is one of the reasons why we screen for good vision in both eyes.


    We emphasize that our research does not show a causal relationship between amblyopia and ill health in adulthood. Our research means that the ‘average’ adult who had amblyopia as a child is more likely to develop these disorders than the ‘average’ adult who did not have amblyopia. The findings don’t mean that every child with amblyopia will inevitably develop cardiometabolic disorders in adult life.”


    Dr Siegfried Wagner, First Author, UCL Institute of Ophthalmology and Moorfields Eye Hospital

    The research was carried out in collaboration with the University of the Aegean, University of Leicester, King’s College London, the National Institute for Health and Care Research (NIHR) Biomedical Research Centre (BRC) at Moorfields Eye Hospital and UCL Institute of Ophthalmology and the NIHR BRC at UCL Great Ormond Street Institute of Child Health and Great Ormond Street Hospital.

    The work was funded by the Medical Research Council, the NIHR and the Ulverscroft Foundation.

    Source:

    Journal reference:

    Wagner, S. K., et al. (2024) Associations between unilateral amblyopia in childhood and cardiometabolic disorders in adult life: a cross-sectional and longitudinal analysis of the UK Biobank. eClinicalMedicine. doi.org/10.1016/j.eclinm.2024.102493.

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  • A Journey into Women’s Brain Health Research

    A Journey into Women’s Brain Health Research

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    In this special International Women’s Day interview on the evolution of neurology with a special focus on women’s brain health, we dive into the work of Cheryl Carcel. With a unique perspective shaped by experiences in both low-middle-income and high-income countries, the conversation sheds light on the critical disparities in neurological care and outcomes between genders. 

    Please could you share with us the journey that led you to focus on neurology and, more specifically, on women’s brain health?

    As a medical student from a low-middle-income country (the Philippines), I was fascinated by neurology, where by taking a person’s medical history and performing physical examinations, it was possible to diagnose with good accuracy a person’s neurological disease. This is crucial in a country with few resources, such as diagnostic imaging.

    During my neurology training, I noticed that women were usually more disabled or likely  to die after a stroke, but I did not realize that this was a global issue. It wasn’t until I started my Ph.D. at the University of Sydney and analyzed some of the stroke clinical trials at The George Institute and found evidence that women indeed had worse outcomes including worse quality of life after stroke compared to men.

    These trials were run internationally, so not only was it happening in the Philippines, where I had first-hand experience with my patients, but also around the globe and even in high-income countries.

    In your research on sex and gender differences within neurology, what have been some of the most surprising or enlightening findings regarding how neurological disorders affect men and women differently?

    It still surprises me that in 2024, women and men still experience these differences. There are two things I want to highlight:

    We know about biological differences in women and men and that these may affect how we respond to diseases like stroke. For example, younger women are more likely to have a stroke than younger men, and this is probably due (to some extent) to hypertensive disorders of pregnancy and gestational hypertension.

    But the gender aspects are more difficult to explain because they may involve the role a woman plays in society – she may not immediately present to the hospital after a stroke (and thereby receive time-dependent life-saving medications) because she has caregiving responsibilities, or she may be older, living alone with no one to call the ambulance. Aside from the role women play in society, there may be differences in the way women and men are treated, or there may be implicit bias from healthcare professionals.

    Participants enrolled in stroke clinical trials are not often representative of the population experiencing the disease in the community. Women, people of color, and individuals from culturally and linguistically diverse backgrounds (CALD) are under-enrolled relative to their burden of disease in stroke. Treatment effect estimates of many medical therapies, including stroke, have been largely derived from trial evidence generated from a Caucasian male population, limiting the generalisability of the safety and efficacy evidence.

    Given the clear differences in how neurological conditions can manifest and impact men and women, how do you believe these insights should influence the development of treatments, patient care, and support systems in neurology?

    Work in this field (mine and many others) suggests that in order to overcome these differences, we need to consider the collection, analysis, and reporting of sex and gender health data and include more diverse populations in our clinical trials in order to provide reliable evidence on how safe and effective new medications and devices are for everyone. There has also been evidence to suggest that when women lead clinical trials, the trial population is more inclusive, and data is more likely to be disaggregated by sex.

    Image Credit: Tunatura/Shutterstock.com

    Image Credit: Tunatura/Shutterstock.com

    What are some of the most significant challenges you face in researching women’s brain health, and how do you propose the scientific community addresses these challenges to ensure more inclusive health outcomes?

    If you had asked me the same question 4 years ago, I would have said that the biggest challenge at that time was convincing the medical and research community that sex and gender differences in stroke/cardiovascular disease is a real problem.

    Now that all these mounting evidence cannot be ignored, the next challenge is to find strategies to narrow this health gap. One of the best ways of doing this is working with end-users—the people with lived experiences, health care professionals, advocacy groups, government, etc to find a solution that works for the people involved.

    You advocate for the disaggregation of data by sex in medical research. Can you explain how this approach has influenced your research outcomes and why it’s crucial for achieving gender equity in health care?

    Gender equality is one of the UN Sustainable Development Goals (Sustainable Development Goal 5). Clinically meaningful sex and gender differences in screening, risk factor prevalence, health-seeking behavior, treatment, and prognosis are increasingly recognized across a range of non-communicable diseases, which confer the greatest health burden.

    Why women and men’s experiences and treatment differ for the same diseases, and how this links to socially embedded gender structures, is under-appreciated in medical research and clinical practice. By disaggregating data by sex and, where possible, gender, we are not only doing good science (Prof Londa Schiebinger’s wise words Gendered Innovations | Stanford University), but we are expanding our knowledge of these differences into the health care system to improve clinical practice, medical research, health systems design, policy, and public health.

    Your trial in Nigeria and Peru focuses on essential acute stroke care in low-resource settings. How do you see this work contributing to a more inclusive approach to global health, especially concerning women’s health care in these regions?

    This trial is funded by the World Heart Federation, and our intention was two-fold: to improve acute stroke care in low-resource settings and to build research capacity in the area. The COVID pandemic has impacted this project, and it is currently on hold as we work through logistical issues. If this trial has a positive outcome, then having clear guidelines on essential acute stroke treatments has the potential to eliminate implicit and explicit gender bias.

    I am also working on another project that aims to improve the participation of women in stroke clinical trials. Ensuring that clinical trials include a balanced proportion of women and men and that key findings are interpreted separately by sex is crucial.

    When women are under-represented in trials, there is a threat that treatment is not safe or effective and introduces the potential for unequal access to treatments. Our ongoing efforts will develop and evaluate inclusive and innovative recruitment strategies to improve the representation of women in stroke trials, making stroke treatment more accessible to all people.

    As women, we need to be brave. Speak up and let your voice be heard and counted when you have something to say. You are important, and your voice matters.

    Based on your experience and research findings, what policies or actions do you believe are essential to advance the inclusion of women’s health needs in both national and international health agendas?

    An important program of work at The George Institute for Global Health in collaboration with the Australian Human Rights Institute at the University of New South Wales in Sydney is an Australia-wide Call to Action to embed sex and gender analysis into medical research. This work has led to the formation of The Sex and Gender Sensitive Research Call to Action Group, which includes 11 universities across Australia, the UK, and the United States committing to analysing and reporting health data by sex.

    A philanthropic group is currently funding a larger project aimed at translating the Call to Action paper. Some key wins of this project so far include mapping the key stakeholder organizations in Australia engaged in sex and gender research advocated for policy changes with the National Health and Medical Research Council and Medical Research Future Fund (the main health funding bodies in Australia) and through a co-design workshop with our group, the Association of Australian Medical Research Institutes (AAMRI), the peak body for medical research institutes across Australia, has produced a set of sex and gender policy recommendations for health and medical research.

    Through these policy changes in different stakeholder groups, we hope that we will achieve critical mass in Australia to make the collection, analysis, and reporting of sex and gender health data the norm and not just nice to do.

    This month, we will be launching Australia’s new National Centre for Sex and Gender Equity in Health and Medicine, which will bring together researchers, policymakers, healthcare professionals, and consumer stakeholders with an interest in addressing the effects of biological sex and gender identify on health outcomes, enabling greater learning, collaboration, and impact. This Centre is a partnership between The George Institute for Global Health, the Australian Human Rights Institute at UNSW Sydney and Deakin University.

    The center aims to develop effective strategies to prevent and treat the leading causes of death and disability for everyone; we need health and medical research that is inclusive and looks at how sex and gender affect different conditions. 

    Reflecting on this year’s theme for International Women’s Day, what does “Inspire Inclusion” mean to you personally and professionally, and how do you envision its implementation in the realm of brain health and beyond?

    This year, the UN’s theme is Count Her In: Invest in Women. Accelerate Progress. It talks a bit about economic empowerment but also provides equal opportunities to earn, learn, and lead. This is very relevant to our work on improving the participation of women in clinical trials. We want to be able to count women in by ensuring their health and medical data are captured; and are safe and effective.

    Where can readers find more information?

    About Cheryl Carcel

    A/Prof Cheryl Carcel is a neurologist and the Head of the Brain Health Program at The George Institute for Global Health in Sydney, Australia. She is a conjoint associate professor at University of New South Wales in Australia. She was selected as a World Heart Federation (WHF) Emerging Leader and a Stroke Society of Australasia Emerging Stroke Clinician and Scientist. Her most important life roles are being a mother of two young and active children and wife.

    Career highlights: 
    •    Recent promotion to Associate Professor at University of New South Wales and Head of the Brain Health Program at The George Institute.
    •    Appointed as acting director of the Centre for Sex and Gender Equity in Health and Medicine- a national centre in Australia that will address sex and gender inequities through world-class research that considers how sex and gender impact health and medicine.
    •    Invited to be one of the keynote speakers in the European Stroke Organisation’s Stroke Science Workshop last year. This is an important achievement as this workshop is a meeting on clinical and translational research aspects of stroke with a limited number of well-known stroke specialists as well as junior scientists. My invitation as a keynote speaker to this meeting signals that sex and gender differences should be considered front and centre in stroke. 

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  • Medical debt is associated with population health and increased mortality

    Medical debt is associated with population health and increased mortality

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    In a recent cross-sectional study published in JAMA Network Open, researchers from the United States of America (US) investigated, at the county level, the association between medical debt and population health outcomes in the US.

    They found that medical debt is associated with worsened health status and increased premature deaths and mortality in the population.

    ​​​​​​​Study: Associations of Medical Debt With Health Status, Premature Death, and Mortality in the US. Image Credit: Pormezz/Shutterstock.com​​​​​​​Study: Associations of Medical Debt With Health Status, Premature Death, and Mortality in the US. Image Credit: Pormezz/Shutterstock.com

    Background

    Increasing economic burden and out-of-pocket costs for healthcare in the US have led to a concerning rise in medical debt, affecting 17.8% of individuals in 2020.

    Certain vulnerable populations, including racial and ethnic minorities, females, younger individuals, and those with chronic diseases face a higher risk of incurring medical debt.

    This debt is linked to adverse impacts on well-being, such as delayed healthcare, prescription nonadherence, and increased food and housing insecurity. Despite these individual-level associations, the county-level impact of medical debt on health outcomes remains poorly understood.

    The present study aimed to address this gap by examining the relationships between medical debt and health status, mortality, and premature death at the county level in the US, using data from the Urban Institute Debt in America project.

    About the study

    In the present study, debt data was obtained from a 2% nationally representative panel of deidentified records from a credit bureau. A total of 2,943 US counties were included, of which 39.2% were in metropolitan regions. The counties had a median 18.3% of residents above 65 years of age.

    The median racial breakdown of residents was as follows: 0.4% American Indian/Alaska Native, 0.8% Asian/Pacific Islander, 3.0% Black, 4.3% Hispanic, and 84.5% White.

    The excluded counties were predominantly non-metropolitan and had a smaller population size and a reduced socio-demographic diversity.

    The study investigated three health outcome sets from public data sources, including self-reported health status, premature death measured by years of potential life lost, and age-adjusted all-cause mortality rates and cause-specific mortality rates for leading causes such as cancers, heart disease, Alzheimer’s, diabetes, and suicide, at the county level in the US.

    Furthermore, the study considered county-level sociodemographic factors from the US Census data, including racial distribution, educational attainment, uninsured status, unemployment, and metropolitan status, as potential confounders.

    The analysis considered two medical debt measures: the primary measure assessed the percentage of individuals with medical debt in collections, while the secondary measure focused on the median amount of medical debt (in 2018 US dollars).

    Overall debt, including medical and other kinds of debt, were also included in the supplementary analyses.

    Statistical analysis involved the use of descriptive analysis as well as bivariate and multivariable linear models, incorporating random state-level intercepts and weighted by county population size.

    Results and discussion

    An average of 19.8% of the studied population had medical debt. Counties with fewer White and more Black residents, lower education levels, increased poverty, lack of insurance, and unemployment appeared to have higher medical debt rates.

    It was found that a 1% increase in the population of medical debt-holders was associated with 18.3 more physically unhealthy days and 17.9 more mentally unhealthy days per 1,000 people in 30 days.

    The percent-increase in medical debt-holders was also found to be associated with 1.12 years of life lost per 1,000 people and a rise of 7.51 per 100,000 person-years in age-adjusted all-cause mortality rate.

    Consistent associations were found for major causes of death, including heart disease, cancer, chronic obstructive pulmonary disease, diabetes, and suicide.

    Patterns were found to be similar for associations between the median amount of medical debt and the selected health outcomes. Supplemental analyses showed similar association patterns between medical debt and health outcomes.

    This nationwide study reaffirms that medical debt remains a significant social determinant of public health.

    However, the study is limited by the potential underrepresentation of medical debt in less populous counties, the inability to examine specific sources of medical debt, the exclusion of individuals not in the credit system, and the need for further research on the impact of coronavirus disease 2019 (COVID-19)-related policies on medical debt and population health.

    Additionally, a broader focus on overall debt suggested that policies addressing various debts, like student loans, may impact population health.

    Conclusion

    In conclusion, the study revealed associations between medical debt and adverse health outcomes, such as increased unhealthy days, premature deaths, and elevated mortality rates.

    The results highlight the need for collaborative efforts among various stakeholders, including government entities, healthcare systems, hospitals, and employers, to mitigate medical debt with paid sick leave, clear financial assistance policies, and improved cost-related communication with patients.

    Further, enhancing access to affordable healthcare through policies like expanding health insurance coverage may improve the overall health of the US population.

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