Patient safety incidents in mental health residential services: a multicenter, crosssectional, survey-based study

IntroductionWhile patient safety in general hospitals is well-researched, residential mental health services have received less attention. Psychiatric patients and staff working in such facilities face unique and complex risks. This study aims to explore and describe the frequency and characteristics of patient safety incidents (PSIs) experienced by professionals working in a cohort of Italian mental health residential services.MethodsA multicenter, cross-sectional, questionnaire-based observational study was conducted involving workers from 68 psychiatric mental health services from seven different Italian provinces. A total of 159 respondents, including both healthcare and non-healthcare professionals, took part in the study. Participants reported incidents personally experienced (FHE) or reported by colleagues (CRE) over the previous 12 months, using a taxonomy adapted from the World Health Organization’s Conceptual Framework for the International Classification for Patient Safety. Data was analyzed using descriptive statistics and zero-inflated models to identify associations between respondent characteristics and reporting behaviors.ResultsA total of 4,432 FHE and 4,807 CRE were reported. The behavior-related events were the most frequently reported, followed by incidents related to organizational or infrastructure issues, and medication errors. Secondary analyses suggested that facilities with more than ten employees had significantly higher rates of both FHE and CRE. Furthermore, residential facilities showed a higher incidence rate of CRE compared to non-residential ones, and non-healthcare workers reported witnessing fewer incidents to colleagues (28%) compared to healthcare workers. Significant variability was also observed across different provinces.ConclusionResidential mental health services experience a high incidence of PSIs, suggesting a risk profile distinct from general hospital settings. The predominance of behavior-related incidents corroborates the hypothesis that primary risks are mainly driven by relational dynamics. The findings highlight that both healthcare and non-healthcare staff are exposed to significant risks, suggesting the need of inclusive and comprehensive safety interventions. Consequently, specific training programs focused on relational risk management, de-escalation, and empathic communication are essential for all workers employed in these settings.

Evaluation of anxiety levels and stress coping methods of pregnant women after the Kahramanmaraş earthquake

ObjectiveNatural disasters can cause serious psychological pressures on women during pregnancy. How the mental health of pregnant women is affected after major disasters such as earthquakes and what coping methods come into play in this process is an important research topic. This study aimed to evaluate the anxiety levels and stress coping strategies of pregnant women who experienced the February 6, 2023 Kahramanmaraş earthquake.MethodsThis cross-sectional descriptive study was carried out within four months after the earthquake. A total of 118 pregnant women were included. Participants were grouped according to pregnancy trimester. Anxiety level was assessed with the Beck Anxiety Inventory and coping strategies with the Brief COPE Scale. Earthquake exposure data, including building damage and loss of relatives, were collected via structured survey.ResultsThe mean Beck Anxiety score was 15.9 ± 12.8. A significant difference was observed between trimesters (H = 19.09, p < 0.001), with anxiety declining from the first to the third trimester. Religious coping (ρ = 0.42, p < 0.001), acceptance (ρ = 0.36, p < 0.001), and behavioral avoidance (ρ = 0.36, p < 0.001) were positively correlated with anxiety. Positive reinterpretation and development showed a significant negative correlation with anxiety (ρ = −0.32, p < 0.001). Building damage category was not significantly associated with anxiety (p = 0.80).ConclusionAnxiety in post-earthquake pregnant women differs according to trimester, and individual coping styles are associated with anxiety levels. Within the scope of the variables measured in this study, positive reinterpretation showed the strongest negative association with anxiety. Approaches supporting cognitive flexibility should be prioritized in perinatal mental health interventions.

STAT+: Revolution Medicines touts ‘unprecedented’ data for pancreatic cancer pill

Metastatic pancreatic cancer patients who received a targeted pill from Revolution Medicines lived nearly twice as long as patients who received chemotherapy, a striking result in a notoriously deadly and intractable malignancy. 

Patients who took the daily pill, called daraxonrasib, lived a median of 13.2 months, compared to 6.7 months for patients who received chemotherapy.

It’s “very impressive,” said Benjamin Weinberg, an associate professor of medicine at Georgetown University who was not involved in the study, in an email.

Continue to STAT+ to read the full story…

STAT+: Spyre Therapeutics IBD drug shows promise in early trial

An inflammatory bowel disease treatment developed by Spyre Therapeutics succeeded in its first major test, setting the company up to compete with several large drugmakers developing new medicines for the chronic digestive condition. 

Spyre is currently running a Phase 2 trial testing three experimental ulcerative colitis drugs as standalone treatments and, eventually, as combination therapies. The company released the first batch of results Monday on one of the treatments, showing it was safe and met the primary goal of the study. 

The therapy, SPY001, targets the alpha 4 beta 7 inflammation pathway, one of the emerging avenues drugmakers are probing to reduce inflammation in the gut. In Spyre’s SKYLINE study, subjects taking SPY001 saw a 9.2 point decrease in a disease activity index. Approximately 40% of the trial subjects went into remission after 12 weeks of use. 

Continue to STAT+ to read the full story…

You have no choice in reading this article—maybe

Uri Maoz loved doing his human research, back when he was getting his PhD. He was studying a very specific topic in computational neuroscience: how the brain instructs our arms to move and how our gray matter in turn perceives that motion. 

Then his professor asked him to deliver an undergrad lecture. Maoz assumed his boss was going to tell him exactly what to do, or at least throw some PowerPoint slides his way. But no. Maoz had free rein to teach anything, as long as it was relevant to the students. “I could have gone to human brain augmentation,” he says. “Cyborgs or whatever.”

Yet that admittedly fun and borderline sci-fi topic wasn’t what popped, unbidden, into his mind. His idea, he recalls with excitement: “What neuroscience has to say about the question of free will!” 

How—or whether—humans make decisions (like, say, about what to discuss in an undergrad lecture) had been on his mind since he’d read an article in his early twenties suggesting that … maybe they didn’t. This question might naturally beget others: Had he even had a choice about whether to read that article in the first place? How would he ever know if he was responsible for making decisions in his life or if he just had the illusion of control?

“After that, there was no turning back,” says Maoz, now a professor at Chapman University, in California. He finished his PhD work in human movement, but afterward he scooted further up the neural chain to find out how desires and beliefs turn into actions—from raising an arm to choosing someone to ask out to dinner on a Friday night.

Today, Maoz is a central figure in the attempt to (sort of, maybe) answer how that neural chain functions. His research has since overturned and reinter­preted canonical neuroscience studies and united the straight-scientific and philosophical sides of the free-will question. More than anything, though, he’s succeeded in uncovering new wrinkles in the debate.

Machines and magic tricks

The concept of free will seems straightforward, but it doesn’t have a universally accepted definition. One intuitive notion is that it’s the ability to make our own decisions and take our own actions on purpose—that we control our lives. But physicists might ask if the universe is deterministic, following a preordained path, and if human choices can still happen in such a universe. 

That’s a question for them, Maoz says. What neuroscientists can do is figure out what’s going on in the brain when people make decisions. “And that’s what we’re trying to do: to understand how our wishes, desires, beliefs, turn into actions,” he says.

By the time Maoz had finished his PhD, in 2008, neuroscientific research into the question had been going on for decades. One foundational study from the 1960s showed that a hand movement—something a person seemingly decides to do—was preceded by the appearance in the brain of an electrical signal called the “readiness potential.” 

Building on that result, in the 1980s a neuroscientist named Benjamin Libet did the experiment that had first piqued Maoz’s interest in the topic—one that many, until recently, interpreted as a death knell for the concept of free will.

An electrical impulse in our brains can shed only so much light on whether we truly are the architects of our own fates.

“He just had people sit there, and whenever they feel like it, they would go like this,” says Maoz, wiggling his wrist. Libet would then ask where a rotating dot was on a screen when they first had the urge to flick. He found that the readiness potential appeared not only before they moved their hand but before they reported having the urge to move—or, in Libet’s interpretation, before they knew they were going to move. 

Studies since have confirmed the observation and shown that the readiness potential appears a second or two—and maybe, fMRI implies, up to 10 seconds—before participants report making a conscious decision. “It suggests we are essentially passengers in a self-driving car,” says Maoz. “The unconscious biological machine does all the steering, but our conscious mind sits in the driver’s seat and takes the credit.” 

Maoz initially approached his own research with variations on Libet’s experiments. He worked with epilepsy patients who already had electrodes in their brains, for clinical purposes, and was able to predict which hand they would raise before they raised it. 

Still, some of the Libet-inspired studies people were doing nagged at him. “All these results were about completely arbitrary decisions. Raise your hand whenever you feel like it,” he says. “Why? No reason.” A decision like that is quite different from, say, choosing to break up with your partner. Try telling someone they weren’t in the driver’s seat for that

The field wasn’t looking at meaningful decisions, he says—the ones that actually set the course of lives. 

Maoz began pulling in philosophers to help guide his approach. They would challenge him to confront the semantic differences between things like intention, desire, and urge. Neuroscientists have tended to lump those concepts together, but philosophers tease them apart: Desire is a want that doesn’t necessarily progress toward an action; urge carries implications of immediacy and compulsion; and intention involves committing to a plan. (Maoz has come to focus specifically on intention—including, recently, the potential intentions of AI.)

In 2017, he organized his first in a series of free-will conferences, drawing many autonomy-interested philosophers. “Thank you so much for coming,” he recalls saying at the opening of the meeting. “As if you had a choice.” One day, the crew took an excursion out on a lake. As the group munched on shrimp, someone joked that they hoped the boat didn’t sink, because everybody in the field would die. 

The comment didn’t make Maoz feel existential dread. Instead, he figured that if the whole field was already there, why not lasso them all into writing a research grant? “He just thinks what should be the next step and just has a very good ability to just make it happen,” says Liad Mudrik, a neuroscientist at Tel Aviv University and a frequent collaborator.

That ability is special among scientists, says Chapman colleague Aaron Schurger, with whom Maoz co-directs the Laboratory for Understanding Consciousness, Intentions, and Decision-Making (LUCID, appropriately). “I really think that Uri is kind of at the nexus of this field right now because he’s really, really good at bringing people together around these big ideas,” he says.

Donations and interruptions

Maoz has recently been making progress on one of the big ideas that have consistently occupied his working hours: how trivial and significant decisions play out differently in the brain. In collaborations with Mudrik, he’s parsed the neural difference between picking and choosing—their terms for arbitrary decisions and those that change your life and tug on your emotions. 

Readiness potential? Their measurements didn’t clock it ahead of choices. In 2019, Maoz and a crew published a paper measuring the electrical activity in people’s brains as they pressed a key to choose one of two nonprofits to donate $1,000 to—for real, with actual dollars. Then the researchers compared that activity with what they saw when the same group pressed a key at random to donate $500 each to two nonprofits. The team saw the readiness potential in the arbitrary decision, but not for the $1,000 question. 

Libet’s result, they concluded, doesn’t apply to the important stuff, which means readiness potential might not actually be a sign that your brain is making a choice before you’re aware of it. “If Libet would have chosen to focus on deliberate decisions, then maybe the entire debate about neuroscience proving free will to be an illusion would have been spared from us,” Mudrik says. 

Maoz’s research has spurred others to reinterpret Libet’s work. It’s “enriched my thought process a great deal,” says Bianca Ivanof, a psychologist whose dissertation scrutinized Libet’s methods. They turn out to identify readiness potential at different times depending on how the rotating-dot setup is designed, complicating the ability to compare and interpret results.

Maoz has also continued to gather data on the subject. Last year, for example, he used an EEG to measure electrical signals in people’s brains as they got ready to press a keyboard space bar. At random moments, he interrupted their preparations with an audible tone and asked them about their intentions. He saw no connection between the readiness potential and whether or not they were planning to tap the key—evidence that the potential doesn’t represent the buildup of either conscious or unconscious plans. The team did see a signal, though, in a different part of the brain when people said they were preparing to move.

So … that’s free will? Sadly, Maoz would be compelled to say Well, not exactly. An electrical impulse in our brains can shed only so much light on whether we truly are the architects of our own fates. And maybe the confusing data from neurons is actually the point. “I don’t think it is a yes-or-no question,” Maoz says. Maybe our less meaningful choices aren’t mindfully made but big ones are; maybe we have the conscious power to change an intended action, but only if our brains are in a particular state. 

Neuroscientists likely can’t figure out, on their own, if free will exists. But they can, Maoz says, parse how semantically distinct decision-making forces—desires, urges, intentions, wishes, beliefs—manifest in our brains and become actions. “That is something that we are making progress on,” he says, “and I think that that’s going to help us understand what we do control.” And perhaps also help us make peace with what we do not. 

Sarah Scoles is a freelance science journalist and author based in southern Colorado.

Opinion: STAT+: Landmines await Vinay Prasad’s successor at the FDA

Vinay Prasad’s short yet two-act tenure at the FDA was wild. How does anyone follow him as the new leader of biologics oversight at the agency?

Someone I know at the FDA joked to me recently that I should be the new director of the Center for Biologics Evaluation and Research (CBER) after Prasad. I literally laughed out loud at how comical that sounded, but it got me thinking: Who would be both willing to do it and could get picked? Further, what’s awaiting them?

Prasad became a favorite punching bag of many, including the Wall Street Journal editorial board and right-wing activists like Laura Loomer. They are teed up to clobber the next person, too.

Continue to STAT+ to read the full story…

Health Issues Linked to Obesity Differ Between Men and Women

A study of middle-aged adults carried out by researchers at Dokuz Eylul University in Turkey shows that health and metabolic profiles differ between men and women with obesity.

The results, which will be presented at the European Congress on Obesity in Istanbul in May, show men with obesity are more likely to develop abdominal fat and have high levels of liver enzymes and triglycerides in the blood than women.

In contrast, women with obesity had higher levels of total and low-density lipoprotein cholesterol and increased inflammatory markers such as C-reactive protein compared with men.

“Our findings reveal intriguing differences in the way men and women respond to obesity,” said presenting author Zeynep Pekel, from Dokuz Eylul University, Izmir, Turkey, in a press statement.

“They show just how important gender-specific research is. Not only are sex differences a powerful player in the pathology and course of obesity, but our results indicate that such differences could be a stepping stone toward finding targeted, sex-based therapies to help in the management of people living with obesity.”

Although it is known that men and women with obesity have different adipose tissue distribution and have differences in metabolism more generally, this knowledge is not widely applied in obesity care.

In this study, Pekel and colleagues carried out an analysis of 1134 adults living with obesity attending a tertiary obesity clinic, including 886 women and 248 men. They measured standard factors like age, body mass index (BMI), waist and hip circumference and blood pressure as well as blood-based biomarkers like lipids, liver enzymes and inflammatory markers such as C-reactive protein, erythrocyte sedimentation rate, and white blood cell count.

The results showed that women were slightly older at 45 years on average. Men had significantly greater waist circumference and systolic blood pressure than women, as well as higher levels of the liver enzymes alanine aminotransferase and gamma‑glutamyl transferase and the kidney health biomarker creatinine. Men also had higher levels of triglycerides than women in the study.

Women with obesity had significantly higher total and low-density lipoprotein cholesterol than men in the study. They also had greater erythrocyte sedimentation rate, C-reactive protein, and platelet count, than the men.

“It’s still early days and these findings need to be confirmed in other patient groups, but they offer important insight into how obesity may affect men and women differently,” said Pekel.

“These differences are likely influenced by biological factors such as hormones, immune responses, and fat distribution. Our next steps are to validate these findings in larger populations, better understand the biological processes behind these differences, and explore how these patterns relate to clinical risk.”

The post Health Issues Linked to Obesity Differ Between Men and Women appeared first on Inside Precision Medicine.

Evaluating an Incentive-Based mHealth App for Physical Activity Promotion Using the Obesity-Related Behavioral Intervention Trial Model: Small Cohort Study

Background: Physical inactivity remains a public health concern, with 42% (around 1 in 2) of women and 34% (around 1 in 3) of men in the United Kingdom, for example, failing to meet moderate-to-vigorous physical activity guidelines. To promote physical activity (PA) at scale, smartphone-based mHealth (mobile health) software apps offer a promising solution. Objective: This study aims to evaluate the feasibility of implementing an mHealth app offering very small (“micro”) financial incentives for PA in Leeds, United Kingdom. Methods: A 5-week single-arm proof-of-concept study was conducted with rolling recruitment among Caterpillar Health app users between September 12 and December 12, 2022 (Obesity-Related Behavioral Intervention Trial model, phase IIa). Users earned microincentives in the form of “points,” redeemable for consumer rewards (eg, movie tickets and gym passes), for meeting personalized daily step goals (US $0.13 per goal achieved; set using data from a 5-day baseline) and completing educational quizzes (US $0.33 per quiz). Descriptive statistics assessed feasibility outcomes (ie, reach, recruitment, retention, engagement, and acceptability) and preliminary effectiveness. Paired-samples tests (<.05) examined changes in weekly mean daily step count (from baseline) and step goal achievement over 5 weeks. Results: Of 285 app downloads, 46 users consented to participate (recruitment rate: 16.1%). Participants (mean age: 39.9, SD 11.1 y; 71.1%, 33/46 woman) had a baseline step count of 5598 (SD 2664) steps/day. A total of 25 participants remained engaged (ie, completed at least 1 quiz) at study week 5 (retention rate: 54.3%). Acceptability was high, with 75% of respondents (12/16) indicating they would recommend the app. Weekly mean daily step count did not significantly increase from baseline (mean difference 317, SD 2273, =.53). Weekly daily step goal achievement rate (%) decreased from study week 1 to 5 (−23.23, SD 22.85, =.02). Conclusions: Despite lower-than-expected recruitment and no statistically significant PA increase, relatively high engagement and acceptability suggest future pilot testing (Obesity-Related Behavioral Intervention Trial model, phase IIb) of a refined intervention (eg, wider selection of loyalty reward partners) and modified study protocol (eg, simplified consent process) is warranted. Trial Registration: ClinicalTrials.gov NCT05294692; https://clinicaltrials.gov/study/NCT05294692

Epigenetics at Birth Links Microbiome to Neurodevelopment, Potentially ASD and ADHD

The results of a study headed by researchers at Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, indicate that the gut microbiome and epigenetics are intertwined, and that both contribute to neurodevelopment.

The researchers showed that epigenetic changes present at birth can impact how an infant’s gut microbiome develops during their first year. They also identified specific epigenetic changes and gut microbes that were associated with signs of autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) when the children were three years old.

“Certain bacteria seem to offer protection, which is exciting because it suggests there could be ways to support a child’s development through diet or probiotics in the future,” said research lead and gastroenterologist Francis Ka Leung Chan, MD. Chan is co-senior author of the team’s published paper in Cell Press Blue, titled “Epigenome-microbiome interplay in early life associates with infants’ neurodevelopmental outcomes,” in which they stated, “We showed that epigenetic alterations at birth were associated with early-life microbiome development and that they determine the risks of neurodevelopmental consequences in children.”

The first years of life are critical for brain development and immune system maturation. Though previous studies have shown that both early epigenetic changes and gut microbiome development can impact health in later life, little is known about how these two systems interact. “Recent data suggest that epigenetic programming of gene expression profiles is sensitive to the early-life environment and can impact health outcomes in children,” the authors wrote. “One environmental cue known to trigger host epigenetic modifications is the genes of bacteria, fungi, and viruses inside the human body, collectively known as the microbiome.”

Co-senior author and public health researcher Hein Min Tun, PhD, of The Chinese University of Hong Kong, commented, “We wanted to see how the epigenome and microbiome interact in early life and if their interaction could influence a child’s risk of developing neurodevelopmental conditions like ASD and ADHD.” The authors added, “New understanding of host-microbe-epigenome interactions and mechanisms of epigenetic changes in early life can be leveraged for the prevention, early detection, and novel interventions of common childhood diseases.”

For their study the researchers characterized DNA methylation patterns from the umbilical cord blood of 571 infants. They paired this information with gut microbiome data collected from 969 infants at two, six, and 12 months of age, and from their parents during the third trimester of pregnancy. When the children reached 36 months of age, the researchers used a behavioral questionnaire to assess their neurodevelopment and investigate links between the microbiome, epigenome, and early signs of ASD and ADHD.

“This, to our knowledge, represents the first longitudinal study with multiple sample types to depict the intimate interplay between perinatal exposures, epigenetic hallmarks, and gut microbiome development and neurodevelopmental outcomes within the first three years of life,” the authors stated.

They found that an infant’s epigenome at birth was associated with birth mode, length of gestation, having older siblings, and maternal allergies, but it was not affected by their parents’ gut microbiomes. Microbiome development, on the other hand, was associated with birth mode, antibiotics, having older siblings, and breastfeeding. Infants who were born by Caesarean section (CS) showed different patterns of DNA methylation for several genes involved in immune responses and brain development. “Some of the changes in methylations of immune- and nervous-system-related genes, associated with CS delivery, are linked to neurodevelopmental outcomes,” they noted.

Their reported findings, the team suggested, “… resonate with studies linking CS to increased risks of immune-mediated and neurodevelopmental disorders, providing mechanistic plausibility through epigenomic and microbial dysbiosis.” The team also showed that an infant’s epigenome at birth impacted how their microbiome developed during their first year. Specifically, infants developed less diverse gut microbiomes at 12 months of age when they showed higher rates of DNA methylation in immune genes involved in recognizing pathogens. “We found that methylation rates in the major histocompatibility complex (MHC) region of infants at birth were linked to differences in the diversity of the infant gut microbiome at 12 months,” they commented.

The behavioral survey revealed that signs of ASD and ADHD in three-year-olds were associated with specific epigenetic patterns and the presence of certain gut microbes. “Importantly, we reported that epigenetic modifications were associated with an increased susceptibility to neurodevelopmental conditions in children, and these effects were in part mediated by microbial colonization.”

However, other microbial species seemed to mitigate these effects: infants with epigenetic patterns associated with ASD or ADHD were less likely to show signs of the disorders if they acquired Lachnospira pectinoschiza and Parabacteroides distasonis, respectively, during their first year. “We discovered a kind of conversation happening: a baby’s epigenetic setting at birth can influence their risk for neurodevelopmental disorders, but the presence of certain ‘good’ bacteria in their gut can step in and modify the risk,” Tun reported. “The foundations for brain health are laid very early, even before birth. However, we don’t want people to think this means a child’s developmental path is fixed at birth. These are complex conditions with many causes, and we’ve only uncovered a small piece of a very large puzzle.”

The researchers are continuing to follow the children who participated in the study to see how these early-life factors relate to their health as they grow. They note that laboratory experiments are needed to confirm the associations between gut microbes and neurodevelopment. In their discussion, the team wrote, “In conclusion, our findings revealed dual alterations to the neonatal epigenome and gut microbiome by perinatal factors and highlight the role of the ‘holo-epigenome’—the integrated host epigenome and microbiome—as a key mediator of neuro-immune outcomes. Interventions targeting microbial restoration or epigenetic modulation during critical developmental windows may mitigate risks of neurodevelopmental disorders.”

First author and gastroenterologist Siew Chien Ng, MD, PhD, added, “The ultimate goal is to develop safe, non-intrusive early interventions such as specific probiotics or live biotherapeutics, that could help nurture a healthy gut microbiome and potentially reduce the risk of neurodevelopmental challenges.”

The post Epigenetics at Birth Links Microbiome to Neurodevelopment, Potentially ASD and ADHD appeared first on GEN – Genetic Engineering and Biotechnology News.