Day: September 5, 2024

Categories : Medical Research & TechnologyTags :

Researchers Attempted to Emulate a Clinical Trial Using Data from Real Patients

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Photo by National Cancer Institute on Unsplash

The method can be used to explore treatment effects in people underrepresented in clinical trials

Researchers used real-world clinical data to attempt to emulate a randomised controlled trial testing the effectiveness of two blood thinners, apixaban and warfarin, to prevent stroke in patients with non-valvular atrial fibrillation. The study, led by Emma Maud Powell at the London School of Hygiene and Tropical Medicine, UK, and publishing August 29th in the open-access journal PLOS Medicine, provides a method to explore the effects of treatments in patients who are underrepresented or excluded from clinical trials.

Patients experiencing atrial fibrillation – a potentially dangerous medical condition in which the upper chambers of the heart beat irregularly – will often be prescribed blood thinners such as apixaban or warfarin to prevent a stroke. However, these treatment recommendations are based on results from randomized controlled trials, and it is unknown if they are applicable to populations of patients who were not included in the trial or present only in very low numbers.

In the new study, researchers used routinely collected health data from patients in the United Kingdom to attempt to emulate a previous randomized controlled trial that compared the effectiveness of apixaban and warfarin. They attempted to emulate the patient eligibility, selection and analysis approaches as the previous trial. They found that patients prescribed apixaban had similar outcomes to patients prescribed warfarin, but unlike the previous trial, they did not find that apixaban was superior. The researchers observed the differences in results may have been linked to higher quality of warfarin control, sub-optimal dosing of apixaban, and differences in the ethnicity of patients and use of concomitant medications compared with the clinical trial population.

Overall, the study established that using an existing randomised controlled trial (the reference trial) as a guide for the design of observational analysis of real patient data is an effective and valid way to estimate the treatment effects and risks of blood thinners given to patients with atrial fibrillation. The methods developed in this study can be used to investigate the effects of these medications in patient groups that are excluded from or underrepresented in these clinical trials, such as the elderly, those with multiple conditions and people with a higher risk of bleeding. This method can also help medical researchers to understand whether results from randomized controlled trials are transferable to “real-world” practices, and provides a framework that can be adapted to investigate treatment effects for other conditions.

The authors add, “Our study aimed to emulate a reference trial in oral anticoagulants in patients with atrial fibrillation using routinely collected UK healthcare data. Reference-trial informed design provides a framework for the study of treatment effects in patient groups excluded from or under-represented in trials.”

Provided by PLOS

Categories : Injury & Trauma NeurologyTags :

More than Mobility: Gaining Independence after a Spinal Cord Injury

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International Spinal Cord Injury Day marked on 5 September 2024

Photo by Elevate on Unsplash

5 September 2024, International Spinal Cord Injury Day is commemorated on Thursday 5 September, drawing attention to the many ways people can be affected by spinal cord injury, creating awareness of prevention, and highlighting the possibilities for a fulfilling life after injury.

According to the World Health Organization, globally, over 15 million people are living with spinal cord injuries. Most of these cases are due to trauma, including falls, road traffic injuries or violence.

Jessica Morris, an occupational therapist at the Netcare Rehabilitation Hospital in Auckland Park, says one of the most critical aspects of care for those who’ve been impacted by spinal cord injuries is the importance of successful rehabilitation through a holistic, integrated approach from a multidisciplinary team.

“Many people just think it’s just about mobility. It’s so much more than that. Rehabilitation is complex because many different areas of our patients’ lives are affected.” Morris says they are fortunate that their team has so many different practitioners who can contribute to treating spinal cord injury patients, helping them regain a level of independence, which is vital to their self-confidence and sense of empowerment.

Dr Anrie Carstens,  a general practitioner with a particular interest in physical medicine and rehabilitation who practises at the Netcare Rehabilitation Hospital, says the message of Spinal Cord Injury Awareness Day has relevance all year round, as people with spinal cord injuries need to be incorporated into society.

“It’s an opportunity to tell people not to be nervous to talk to someone in a wheelchair. They’re just like you or me, and they just have special ways of moving around and managing their pain and different aspects of their bodies. With the help of proper rehabilitation, the person can be better integrated as a functional, contributing member of society.”

Dr Carstens says people should also be aware that if they or their loved ones are ever impacted by a spinal cord injury, professional support is available. “Don’t just go straight home after your hospital stay and try to do everything on your own. Instead, come to a specialised spinal cord injury unit like ours, with therapists, doctors and nursing staff who are well versed in spinal cord injury and know the finer nuances necessary to optimally treat the person and show them how best to cope with their injury.

“In the multidisciplinary approach, every practitioner has a role in getting the person back into the real world, whether it means going back home, back to school, back to work or wherever they were before their injury occurred.”

From doctors and nurses with specialised skills to physiotherapists, occupational therapists, social workers and psychologists, speech therapists, a prosthetist and dieticians, the team provides a broad person focussed rehabilitation service to both adults and children. Their aim is to optimise their patients’ independence level using specialised equipment and teaching specific techniques to help overcome the obstacles a person may face.

Dr Carstens says it’s rewarding work for the staff at the hospital, who build up enduring relationships with those they care for. “One of the highlights is to compare and see what the patient was like when you admitted them and then see on discharge how much they’ve grown, how they’ve gained confidence and become more independent. What’s even better is to see them after they’ve been discharged and observe how well they’ve coped and how they’ve integrated and adjusted to their environment. We build a relationship with our patients because they stay with us for quite a while, and we usually have checkups every year after the person is discharged, often for life. We get to see them grow and thrive outside the healthcare setting, and we need more awareness about how much it is possible for people with spinal cord injuries to achieve.” 

Categories : Gender Immune SystemTags :

New Research Explains Differences in Men’s and Women’s Immune Systems

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Photo by Daniil Onischenko on Unsplash

By analysing the immune system of female-to-male transgender individuals, Swedish researchers demonstrate the role of sex hormones in regulating the immune system. This newfound knowledge, published in Nature, explains differences between men and women, particularly in terms of immune signalling, and can be used to develop new immunological medications according to researchers.

Sex differences in the immune system are regulated both by genetics and by sex hormones. However, immunological comparisons between men and women can never fully distinguish the significance of genetic versus hormonal variations.

Now, three Swedish research groups led by Karolinska Institutet and Uppsala University has conducted a unique study analysing the regulation and adaptation of the immune system over time in 23 trans men who have undergone gender-affirming testosterone treatment, starting at the age of 18–37 years.

“We have followed individuals who were assigned female sex at birth and later received testosterone treatment in adulthood. Their genetic profile remains unchanged, while their hormone profile shifts entirely from typically female to male hormone levels,” says Petter Brodin, paediatrician and professor of paediatric immunology at the Department of Women’s and Children’s Health, Karolinska Institutet, who led the study together with Nils Landegren, assistant professor at Uppsala University, and Olle Kämpe, Professor at the Department of Medicine, Solna, Karolinska Institutet. “This unique change allows us, for the first time, to identify which parts of a person’s immune system are directly regulated by sex hormones rather than genetic sex differences.” 

The researchers can now demonstrate that increased testosterone levels and the accompanying reduction in oestrogen particularly affect the balance between two crucial immune signalling systems: antiviral interferon type 1 (IFN-1) and proinflammatory signals such as tumour necrosis factor alpha (TNFα).  

Specifically, they found that testosterone modulates a cross-regulated axis between type-I interferon and tumour necrosis factor. This is mediated by functional attenuation of type-I interferon responses in both plasmacytoid dendritic cells and monocytes. Conversely, testosterone potentiates monocyte responses leading to increased tumour necrosis factor, interleukin-6 and interleukin-15 production and downstream activation of nuclear factor kappa B-regulated genes and potentiation of interferon-γ responses, primarily in natural killer cells. 

The immune system changes throughout life

They also have a hypothesis about why the immune system needs to be dynamically regulated by hormones throughout life. 

“All individuals must be able to adjust their immune systems over the course of their lives to be optimally regulated for the conditions and challenges we face. During puberty and sexual maturation, new demands arise, and the immune system must be regulated differently to enable pregnancy in women and muscle growth in men,” says Petter Brodin. 

By regulating these key functions via sex hormones, this can be achieved, and in women, it is dynamically controlled even during a menstrual cycle,” he adds. 

The results of the study open an entirely new field of research, according to Nils Landegren. 

“The newfound knowledge will help us better influence people’s immune systems even without using sex hormones. For example, new drugs can be developed to impact these regulatory mechanisms and thus rebalance the immune response, especially for women with the autoimmune rheumatic disease SLE,” he explains. 

However, the results also have a more direct implications for transgender individuals. 

“This research is also of crucial for transgender individuals undergoing gender-affirming hormone therapy, and I believe that this group deserves significantly more scientific attention and follow-up to ensure their long-term health,” says Petter Brodin. 

Source: Karolinska Institutet

Categories : Ageing GeneticsTags :

A Breakthrough Discovery of Gene that may Extend Longevity

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Source: CC0

Researchers from the Center for Healthy Aging, Department of Cellular and Molecular Medicine at the University of Copenhagen have made a breakthrough in lifespan research. They have discovered that a particular protein known as OSER1 has a great influence on longevity.

”We identified this protein that can extend longevity. It is a novel pro-longevity factor, and it is a protein that exists in various animals, such as fruit flies, nematodes, silkworms, and in humans,” says Professor Lene Juel Rasmussen, senior author behind the new study.

Because the protein is present in various animals, the researchers conclude that new results also apply to humans:

”We identified a protein commonly present in different animal models and humans. We screened the proteins and linked the data from the animals to the human cohort also used in the study. This allows us to understand whether it is translatable into humans or not,” says Zhiquan Li, who is a first author behind the new study and adds:

“If the gene only exists in animal models, it can be hard to translate to human health, which is why we, in the beginning, screened the potential longevity proteins that exist in many organisms, including humans. Because at the end of the day we are interested in identifying human longevity genes for possible interventions and drug discoveries.”

Paves the way for new treatment

The researchers discovered OSER1 when they studied a larger group of proteins regulated by the major transcription factor FOXO, known as a longevity regulatory hub.

“We found 10 genes that, when – we manipulated their expression – longevity changed. We decided to focus on one of these genes that affected longevity most, called the OSER1 gene,” says Zhiquan Li.

When a gene is associated with shorter a life span, the risk of premature aging and age-associated diseases increases. Therefore, knowledge of how OSER1 functions in the cells and preclinical animal models is vital to our overall knowledge of human aging and human health in general.

“We are currently focused on uncovering the role of OSER1 in humans, but the lack of existing literature presents a challenge, as very little has been published on this topic to date. This study is the first to demonstrate that OSER1 is a significant regulator of aging and longevity. In the future, we hope to provide insights into the specific age-related diseases and aging processes that OSER1 influences,” says Zhiquan Li.

The researchers also hope that the identification and characterization of OSER1 will provide new drug targets for age-related diseases such as metabolic diseases, cardiovascular and neuro degenerative diseases.

“Thus, the discovery of this new pro-longevity factor allows us to understand longevity in humans better,” says Zhiquan Li.

Source: University of Copenhagen – The Faculty of Health and Medical Sciences

Categories : Addiction Mental HealthTags :

Unhealthy Commodities – Like Alcohol and Social Media – are Connected with Poor Mental Health

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Commercial determinants such as social media, air pollution associated with depression and suicide

Photo by Inzmam Khan

“Unhealthy commodities” such as tobacco, alcohol, ultra-processed foods, social media, and fossil fuels, as well as impacts of fossil fuel consumption such as climate change and air pollution are associated with depression, suicide, and self-harm, according to a study published August 28 by Kate Dun-Campbell from the London School of Hygiene & Tropical Medicine, and colleagues.

Globally, around one out of every eight people currently live with a mental health disorder. These disorders – including depression, suicide, anxiety, and other diseases and disorders – can have many underlying causes. Some of those causes could be related to commercial determinants of health – the ways in which commercial activities and commodities impact health and equity. Commercial determinants of health can be specifically unhealthy, such as alcohol or tobacco consumption, unhealthy food, and the use of fossil fuels. To further understand how these unhealthy commodities might impact mental health, the authors of this study performed an umbrella synthesis of 65 review studies examining connections between six specific commodities – tobacco, alcohol, ultra-processed foods, gambling, social media, and fossil fuels. The author also included studies looking at mental health impacts of fossil fuel use such as climate change and air pollution.

The umbrella review found evidence for links between depression and alcohol, tobacco, gambling, social media, ultra-processed foods and air pollution. Alcohol, tobacco, gambling, social media, climate change and air pollution were associated with suicide, and social media was also associated with self-harm. Climate change and air pollution were also linked to anxiety. The review brought together many different methodologies and measurements, and could not establish the underlying cause of the negative mental health outcomes. But the results indicate that unhealthy commodities should be considered when researchers attempt to understand and improve mental ill health. 

The authors add: “Our review highlights that there is already compelling evidence of the negative impact of unhealthy products on mental health, despite key gaps in understanding the impact of broader commercial practices.”

The study was published in PLOS Global Health.

Provided by PLOS

Categories : Cardiovascular Disease Obstetrics & GynaecologyTags :

AI-enabled ‘Digital Stethoscope’ can Diagnose Peripartum Cardiomyopathy Twice as Often

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Source: CC0

New research from Mayo Clinic suggests that artificial intelligence (AI) could improve the diagnosis of peripartum cardiomyopathy, a potentially life-threatening and treatable condition that weakens the heart muscle of women during pregnancy or in the months after giving birth. Researchers used an AI-enabled digital stethoscope that captures electrocardiogram (ECG) data and heart sounds to identify twice as many cases of peripartum cardiomyopathy as compared to regular care, according to a news release from the American Heart Association.

Identifying a weak heart pump caused by pregnancy is important because the symptoms, such as shortness of breath when lying down, swelling of hands and feet, weight gain, and rapid heartbeat, can be confused with normal symptoms of pregnancy.

Dr Demilade Adedinsewo, a cardiologist at Mayo Clinic, shared research insights during a late-breaking science presentation at the American Heart Association’s Scientific Sessions 2023.

Women in Nigeria have the highest reported incidence of peripartum cardiomyopathy. The randomised pragmatic clinical trial enrolled 1195 women receiving pregnancy care in Nigeria. Approximately half were evaluated with AI-guided screening using the digital stethoscope, and half received usual obstetric care in addition to a clinical ECG. An echocardiogram was used to confirm when the AI-enabled digital stethoscope predicted peripartum cardiomyopathy. Overall, 4% of the pregnant and postpartum women in the intervention arm of the clinical trial had cardiomyopathy compared to 2% in the control arm, suggesting that half are likely undetected with usual care.

Watch: Dr Adedinsewo explains the red flags for heart failure during pregnancy

Source: Mayo Clinic