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No Increased Stroke Risk After COVID-19 Bivalent Vaccine

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Changed
Thu, 04/11/2024 - 16:00

 

TOPLINE:

Receipt of the bivalent COVID-19 vaccine was not associated with an increased stroke risk in the first 6 weeks after vaccination with either the Pfizer or Moderna vaccines, a new study of Medicare beneficiaries showed.

METHODOLOGY:

  • The analysis included 5.4 million people age ≥ 65 years who received either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna bivalent vaccine, or the Pfizer vaccine and a high-dose or adjuvanted concomitant influenza vaccine (ie, administered on the same day).
  • A total of 11,001 of the cohort experienced a stroke in the first 90 days after vaccination.
  • The main outcome was stroke risk (nonhemorrhagic stroke, transient ischemic attack [TIA], or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day window after vaccination vs the 43- to 90-day control window.
  • The mean age of participants was 74 years, and 56% were female.

TAKEAWAY:

  • There was no statistically significant association with either brand of the COVID-19 bivalent vaccine or any of the stroke outcomes during the 1- to 21-day or 22- to 42-day risk window compared with the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12).
  • Vaccination with COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine (n = 4596) was associated with a significantly greater risk for nonhemorrhagic stroke 22-42 days after vaccination with Pfizer-BioNTech (IRR, 1.20; risk difference/100,000 doses, 3.13) and an increase in TIA risk 1-21 days after vaccination with Moderna (IRR, 1.35; risk difference/100,000 doses, 3.33).
  • There was a significant association between vaccination with a high-dose or adjuvanted influenza vaccine (n = 21,345) and nonhemorrhagic stroke 22-42 days after vaccination (IRR, 1.09; risk difference/100,000 doses, 1.65).

IN PRACTICE:

“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the authors wrote. “Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”

SOURCE:

Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.

LIMITATIONS:

Some stroke cases may have been missed or misclassified. The study included only vaccinated individuals — a population considered to have health-seeking behaviors — which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.

DISCLOSURES:

This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Dr. Lu reported no relevant financial relationships. The other authors’ disclosures are listed in the original paper.

A version of this article appeared on Medscape.com.

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TOPLINE:

Receipt of the bivalent COVID-19 vaccine was not associated with an increased stroke risk in the first 6 weeks after vaccination with either the Pfizer or Moderna vaccines, a new study of Medicare beneficiaries showed.

METHODOLOGY:

  • The analysis included 5.4 million people age ≥ 65 years who received either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna bivalent vaccine, or the Pfizer vaccine and a high-dose or adjuvanted concomitant influenza vaccine (ie, administered on the same day).
  • A total of 11,001 of the cohort experienced a stroke in the first 90 days after vaccination.
  • The main outcome was stroke risk (nonhemorrhagic stroke, transient ischemic attack [TIA], or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day window after vaccination vs the 43- to 90-day control window.
  • The mean age of participants was 74 years, and 56% were female.

TAKEAWAY:

  • There was no statistically significant association with either brand of the COVID-19 bivalent vaccine or any of the stroke outcomes during the 1- to 21-day or 22- to 42-day risk window compared with the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12).
  • Vaccination with COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine (n = 4596) was associated with a significantly greater risk for nonhemorrhagic stroke 22-42 days after vaccination with Pfizer-BioNTech (IRR, 1.20; risk difference/100,000 doses, 3.13) and an increase in TIA risk 1-21 days after vaccination with Moderna (IRR, 1.35; risk difference/100,000 doses, 3.33).
  • There was a significant association between vaccination with a high-dose or adjuvanted influenza vaccine (n = 21,345) and nonhemorrhagic stroke 22-42 days after vaccination (IRR, 1.09; risk difference/100,000 doses, 1.65).

IN PRACTICE:

“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the authors wrote. “Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”

SOURCE:

Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.

LIMITATIONS:

Some stroke cases may have been missed or misclassified. The study included only vaccinated individuals — a population considered to have health-seeking behaviors — which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.

DISCLOSURES:

This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Dr. Lu reported no relevant financial relationships. The other authors’ disclosures are listed in the original paper.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Receipt of the bivalent COVID-19 vaccine was not associated with an increased stroke risk in the first 6 weeks after vaccination with either the Pfizer or Moderna vaccines, a new study of Medicare beneficiaries showed.

METHODOLOGY:

  • The analysis included 5.4 million people age ≥ 65 years who received either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna bivalent vaccine, or the Pfizer vaccine and a high-dose or adjuvanted concomitant influenza vaccine (ie, administered on the same day).
  • A total of 11,001 of the cohort experienced a stroke in the first 90 days after vaccination.
  • The main outcome was stroke risk (nonhemorrhagic stroke, transient ischemic attack [TIA], or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day window after vaccination vs the 43- to 90-day control window.
  • The mean age of participants was 74 years, and 56% were female.

TAKEAWAY:

  • There was no statistically significant association with either brand of the COVID-19 bivalent vaccine or any of the stroke outcomes during the 1- to 21-day or 22- to 42-day risk window compared with the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12).
  • Vaccination with COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine (n = 4596) was associated with a significantly greater risk for nonhemorrhagic stroke 22-42 days after vaccination with Pfizer-BioNTech (IRR, 1.20; risk difference/100,000 doses, 3.13) and an increase in TIA risk 1-21 days after vaccination with Moderna (IRR, 1.35; risk difference/100,000 doses, 3.33).
  • There was a significant association between vaccination with a high-dose or adjuvanted influenza vaccine (n = 21,345) and nonhemorrhagic stroke 22-42 days after vaccination (IRR, 1.09; risk difference/100,000 doses, 1.65).

IN PRACTICE:

“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the authors wrote. “Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”

SOURCE:

Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.

LIMITATIONS:

Some stroke cases may have been missed or misclassified. The study included only vaccinated individuals — a population considered to have health-seeking behaviors — which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.

DISCLOSURES:

This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Dr. Lu reported no relevant financial relationships. The other authors’ disclosures are listed in the original paper.

A version of this article appeared on Medscape.com.

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Common Household Chemicals Tied to Brain Cell Damage

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Changed
Wed, 04/10/2024 - 10:18

Two classes of chemicals present in common household products may impair the development of oligodendrocytes, the myelinating cells of the central nervous system (CNS), which are critical to brain development and function. However, the researchers as well as outside experts agree more research is needed before any firm conclusions can be drawn. 

Quaternary ammonium compounds, ubiquitous in disinfecting agents and personal care products, and organophosphate flame retardants, which are commonly found in household items such as furniture and electronics had “surprising effects specifically on the non-nerve cells in the brain,” said lead researcher Paul Tesar, PhD, professor and director of the Institute for Glial Sciences, Case Western Reserve University School of Medicine, Cleveland. 

“Other studies have shown that our exposures to the chemicals in disinfecting agents nearly doubled during the pandemic,” Dr. Tesar noted. The finding that quaternary ammonium chemicals in disinfecting agents are harmful to specific brain cells suggests “we need to think about our increased utilization and exposure,” he added.

The results were published online on March 25 in Nature Neuroscience
 

Motor Dysfunction

Exposure to various chemicals in the environment has been shown to impair brain development. However, most of this research has focused on neurons. Less is known about effects on oligodendrocytes, which form the electrical insulation around the axons of CNS cells. Oligodendrocyte development continues from before birth into adulthood, thus these cells may be particularly vulnerable to damage from toxic chemicals.

The researchers analyzed the effects of 1823 chemicals on mouse oligodendrocyte development in cell cultures. They identified 292 chemicals that cause oligodendrocytes to die and 47 that inhibit oligodendrocyte generation. These chemicals belonged to two different classes.

They found that quaternary compounds were potently and selectively cytotoxic to developing oligodendrocytes and that organophosphate flame retardants prematurely arrested oligodendrocyte maturation. These effects were confirmed in mice and cultured human oligodendrocytes.

In addition, an analysis of epidemiologic data from the National Health and Nutrition Examination Survey (2013-2018) showed that one flame retardant metabolite, bis(1,3-dichloro-2-propy) phosphate (BDCIPP), was present in nearly all urine samples of children aged 3-11 years who were examined (1753 out of 1763 children).

After adjustment for multiple confounding factors, results showed that compared with children with urinary BDCIPP concentration in the lowest quartile, those with concentrations in the highest quartile were twice as likely to require special education (adjusted odds ratio [aOR], 2.0; 95% CI, 1.0-3.8) and were six times as likely to have gross motor dysfunction (aOR, 6.0; 95% CI, 1.7-21.9).

Children with urinary BDCIPP concentration within the third quartile also had significantly increased odds of motor dysfunction (aOR, 4.2; 95% CI, 1.1-16.2). 

“These results suggest that the identified chemicals are potentially hazardous to human health. However, we want to be clear that more studies are needed to make definitive connections between chemical exposure and human disease,” said Dr. Tesar.

“Future studies will need to deepen our understanding of the duration and timing of exposure required to initiate or exacerbate disease. This information is needed before specific recommendations, such as behavioral interventions, can be made to reduce exposure. Some of these chemicals have useful roles in our homes, but we need to consider how they’re being used and what level of exposure might be considered safe,” Dr. Tesar said. 

In his view, the results “provide a starting point to understand what exposure levels to these chemicals might be putting ourselves or kids at risk for toxicity.”
 

 

 

Too Soon to Tell

Commenting for this news organization, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who was not involved in the study, echoed the need for more research. 

“The biological mechanisms uncovered provide plausible pathways by which these chemicals could potentially impact human brain development related to oligodendrocytes and myelination. Oligodendrocytes play a critical role in plastic neurological processes throughout life, not just early neurodevelopment. So, disrupting their maturation and function theoretically could contribute to neurodevelopmental disorders as well as adult conditions like multiple sclerosis,” Dr. Lakhan said. 

“This study alone shouldn’t sound neurotoxicant alarms yet. We’ve seen many past chemical scares like saccharin and phthalates fizzle despite alarming lab results when real-world human brain impacts failed to materialize,” Dr. Lakhan cautioned. 

“Far more rigorous research directly linking household chemical exposures to cognitive deficits in people is still needed before drawing firm conclusions or prompting overreactions from the general public. Policymakers will eventually need to weigh potential risks vs benefits, but no definitive human health threat has currently been established,” Dr. Lakhan said. 

Sarah Evans, PhD, MPH, assistant professor in the Department of Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai in New York, also emphasized the need for further study.

“Given that most of the experiments in this study were conducted in isolated cells and a mouse model, further research is needed to determine whether exposure to these chemicals at levels experienced by the general population during critical windows of development impairs myelination and leads to adverse health outcomes like learning and behavior problems in humans,” said Dr. Evans, who was involved in the study.

“The authors’ finding of an association between higher urinary levels of the organophosphate flame-retardant metabolite BDCIPP and gross motor problems or need for special education in children aged 3-11 years in the CDC National Health and Nutrition Examination Survey strengthens their laboratory findings and warrants further investigation,” Dr. Evans added. 

The research was supported by grants from the National Institutes of Health, National Multiple Sclerosis Society, Howard Hughes Medical Institute and New York Stem Cell Foundation, and philanthropic support by sTF5 Care and the Long, Walter, Peterson, Goodman, and Geller families. Dr. Tesar, Dr. Lakhan, and Dr. Evans report no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

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Two classes of chemicals present in common household products may impair the development of oligodendrocytes, the myelinating cells of the central nervous system (CNS), which are critical to brain development and function. However, the researchers as well as outside experts agree more research is needed before any firm conclusions can be drawn. 

Quaternary ammonium compounds, ubiquitous in disinfecting agents and personal care products, and organophosphate flame retardants, which are commonly found in household items such as furniture and electronics had “surprising effects specifically on the non-nerve cells in the brain,” said lead researcher Paul Tesar, PhD, professor and director of the Institute for Glial Sciences, Case Western Reserve University School of Medicine, Cleveland. 

“Other studies have shown that our exposures to the chemicals in disinfecting agents nearly doubled during the pandemic,” Dr. Tesar noted. The finding that quaternary ammonium chemicals in disinfecting agents are harmful to specific brain cells suggests “we need to think about our increased utilization and exposure,” he added.

The results were published online on March 25 in Nature Neuroscience
 

Motor Dysfunction

Exposure to various chemicals in the environment has been shown to impair brain development. However, most of this research has focused on neurons. Less is known about effects on oligodendrocytes, which form the electrical insulation around the axons of CNS cells. Oligodendrocyte development continues from before birth into adulthood, thus these cells may be particularly vulnerable to damage from toxic chemicals.

The researchers analyzed the effects of 1823 chemicals on mouse oligodendrocyte development in cell cultures. They identified 292 chemicals that cause oligodendrocytes to die and 47 that inhibit oligodendrocyte generation. These chemicals belonged to two different classes.

They found that quaternary compounds were potently and selectively cytotoxic to developing oligodendrocytes and that organophosphate flame retardants prematurely arrested oligodendrocyte maturation. These effects were confirmed in mice and cultured human oligodendrocytes.

In addition, an analysis of epidemiologic data from the National Health and Nutrition Examination Survey (2013-2018) showed that one flame retardant metabolite, bis(1,3-dichloro-2-propy) phosphate (BDCIPP), was present in nearly all urine samples of children aged 3-11 years who were examined (1753 out of 1763 children).

After adjustment for multiple confounding factors, results showed that compared with children with urinary BDCIPP concentration in the lowest quartile, those with concentrations in the highest quartile were twice as likely to require special education (adjusted odds ratio [aOR], 2.0; 95% CI, 1.0-3.8) and were six times as likely to have gross motor dysfunction (aOR, 6.0; 95% CI, 1.7-21.9).

Children with urinary BDCIPP concentration within the third quartile also had significantly increased odds of motor dysfunction (aOR, 4.2; 95% CI, 1.1-16.2). 

“These results suggest that the identified chemicals are potentially hazardous to human health. However, we want to be clear that more studies are needed to make definitive connections between chemical exposure and human disease,” said Dr. Tesar.

“Future studies will need to deepen our understanding of the duration and timing of exposure required to initiate or exacerbate disease. This information is needed before specific recommendations, such as behavioral interventions, can be made to reduce exposure. Some of these chemicals have useful roles in our homes, but we need to consider how they’re being used and what level of exposure might be considered safe,” Dr. Tesar said. 

In his view, the results “provide a starting point to understand what exposure levels to these chemicals might be putting ourselves or kids at risk for toxicity.”
 

 

 

Too Soon to Tell

Commenting for this news organization, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who was not involved in the study, echoed the need for more research. 

“The biological mechanisms uncovered provide plausible pathways by which these chemicals could potentially impact human brain development related to oligodendrocytes and myelination. Oligodendrocytes play a critical role in plastic neurological processes throughout life, not just early neurodevelopment. So, disrupting their maturation and function theoretically could contribute to neurodevelopmental disorders as well as adult conditions like multiple sclerosis,” Dr. Lakhan said. 

“This study alone shouldn’t sound neurotoxicant alarms yet. We’ve seen many past chemical scares like saccharin and phthalates fizzle despite alarming lab results when real-world human brain impacts failed to materialize,” Dr. Lakhan cautioned. 

“Far more rigorous research directly linking household chemical exposures to cognitive deficits in people is still needed before drawing firm conclusions or prompting overreactions from the general public. Policymakers will eventually need to weigh potential risks vs benefits, but no definitive human health threat has currently been established,” Dr. Lakhan said. 

Sarah Evans, PhD, MPH, assistant professor in the Department of Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai in New York, also emphasized the need for further study.

“Given that most of the experiments in this study were conducted in isolated cells and a mouse model, further research is needed to determine whether exposure to these chemicals at levels experienced by the general population during critical windows of development impairs myelination and leads to adverse health outcomes like learning and behavior problems in humans,” said Dr. Evans, who was involved in the study.

“The authors’ finding of an association between higher urinary levels of the organophosphate flame-retardant metabolite BDCIPP and gross motor problems or need for special education in children aged 3-11 years in the CDC National Health and Nutrition Examination Survey strengthens their laboratory findings and warrants further investigation,” Dr. Evans added. 

The research was supported by grants from the National Institutes of Health, National Multiple Sclerosis Society, Howard Hughes Medical Institute and New York Stem Cell Foundation, and philanthropic support by sTF5 Care and the Long, Walter, Peterson, Goodman, and Geller families. Dr. Tesar, Dr. Lakhan, and Dr. Evans report no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

Two classes of chemicals present in common household products may impair the development of oligodendrocytes, the myelinating cells of the central nervous system (CNS), which are critical to brain development and function. However, the researchers as well as outside experts agree more research is needed before any firm conclusions can be drawn. 

Quaternary ammonium compounds, ubiquitous in disinfecting agents and personal care products, and organophosphate flame retardants, which are commonly found in household items such as furniture and electronics had “surprising effects specifically on the non-nerve cells in the brain,” said lead researcher Paul Tesar, PhD, professor and director of the Institute for Glial Sciences, Case Western Reserve University School of Medicine, Cleveland. 

“Other studies have shown that our exposures to the chemicals in disinfecting agents nearly doubled during the pandemic,” Dr. Tesar noted. The finding that quaternary ammonium chemicals in disinfecting agents are harmful to specific brain cells suggests “we need to think about our increased utilization and exposure,” he added.

The results were published online on March 25 in Nature Neuroscience
 

Motor Dysfunction

Exposure to various chemicals in the environment has been shown to impair brain development. However, most of this research has focused on neurons. Less is known about effects on oligodendrocytes, which form the electrical insulation around the axons of CNS cells. Oligodendrocyte development continues from before birth into adulthood, thus these cells may be particularly vulnerable to damage from toxic chemicals.

The researchers analyzed the effects of 1823 chemicals on mouse oligodendrocyte development in cell cultures. They identified 292 chemicals that cause oligodendrocytes to die and 47 that inhibit oligodendrocyte generation. These chemicals belonged to two different classes.

They found that quaternary compounds were potently and selectively cytotoxic to developing oligodendrocytes and that organophosphate flame retardants prematurely arrested oligodendrocyte maturation. These effects were confirmed in mice and cultured human oligodendrocytes.

In addition, an analysis of epidemiologic data from the National Health and Nutrition Examination Survey (2013-2018) showed that one flame retardant metabolite, bis(1,3-dichloro-2-propy) phosphate (BDCIPP), was present in nearly all urine samples of children aged 3-11 years who were examined (1753 out of 1763 children).

After adjustment for multiple confounding factors, results showed that compared with children with urinary BDCIPP concentration in the lowest quartile, those with concentrations in the highest quartile were twice as likely to require special education (adjusted odds ratio [aOR], 2.0; 95% CI, 1.0-3.8) and were six times as likely to have gross motor dysfunction (aOR, 6.0; 95% CI, 1.7-21.9).

Children with urinary BDCIPP concentration within the third quartile also had significantly increased odds of motor dysfunction (aOR, 4.2; 95% CI, 1.1-16.2). 

“These results suggest that the identified chemicals are potentially hazardous to human health. However, we want to be clear that more studies are needed to make definitive connections between chemical exposure and human disease,” said Dr. Tesar.

“Future studies will need to deepen our understanding of the duration and timing of exposure required to initiate or exacerbate disease. This information is needed before specific recommendations, such as behavioral interventions, can be made to reduce exposure. Some of these chemicals have useful roles in our homes, but we need to consider how they’re being used and what level of exposure might be considered safe,” Dr. Tesar said. 

In his view, the results “provide a starting point to understand what exposure levels to these chemicals might be putting ourselves or kids at risk for toxicity.”
 

 

 

Too Soon to Tell

Commenting for this news organization, Shaheen Lakhan, MD, a neurologist and researcher based in Miami, who was not involved in the study, echoed the need for more research. 

“The biological mechanisms uncovered provide plausible pathways by which these chemicals could potentially impact human brain development related to oligodendrocytes and myelination. Oligodendrocytes play a critical role in plastic neurological processes throughout life, not just early neurodevelopment. So, disrupting their maturation and function theoretically could contribute to neurodevelopmental disorders as well as adult conditions like multiple sclerosis,” Dr. Lakhan said. 

“This study alone shouldn’t sound neurotoxicant alarms yet. We’ve seen many past chemical scares like saccharin and phthalates fizzle despite alarming lab results when real-world human brain impacts failed to materialize,” Dr. Lakhan cautioned. 

“Far more rigorous research directly linking household chemical exposures to cognitive deficits in people is still needed before drawing firm conclusions or prompting overreactions from the general public. Policymakers will eventually need to weigh potential risks vs benefits, but no definitive human health threat has currently been established,” Dr. Lakhan said. 

Sarah Evans, PhD, MPH, assistant professor in the Department of Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai in New York, also emphasized the need for further study.

“Given that most of the experiments in this study were conducted in isolated cells and a mouse model, further research is needed to determine whether exposure to these chemicals at levels experienced by the general population during critical windows of development impairs myelination and leads to adverse health outcomes like learning and behavior problems in humans,” said Dr. Evans, who was involved in the study.

“The authors’ finding of an association between higher urinary levels of the organophosphate flame-retardant metabolite BDCIPP and gross motor problems or need for special education in children aged 3-11 years in the CDC National Health and Nutrition Examination Survey strengthens their laboratory findings and warrants further investigation,” Dr. Evans added. 

The research was supported by grants from the National Institutes of Health, National Multiple Sclerosis Society, Howard Hughes Medical Institute and New York Stem Cell Foundation, and philanthropic support by sTF5 Care and the Long, Walter, Peterson, Goodman, and Geller families. Dr. Tesar, Dr. Lakhan, and Dr. Evans report no relevant disclosures. 
 

A version of this article appeared on Medscape.com.

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Hemorrhagic Stroke a Key Driver of Spike in US Stroke Rates

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Changed
Wed, 03/27/2024 - 13:37

 

TOPLINE:

Age-standardized stroke rates decreased in the United States between 1990 and 2019, while absolute stroke incidence, prevalence, mortality, and disability-adjusted life years (DALYs) rates increased, a new study showed. Investigators noted the findings, which also show a significant increase in hemorrhagic stroke and an uptick in stroke among adults under 50 years in the South and Midwest, suggesting a significant shift in the US stroke burden.

METHODOLOGY:

  • This in-depth, cross-sectional analysis of the 2019 Global Burden of Disease study included data on all-cause and ischemic strokes, intracerebral hemorrhages (ICHs), and subarachnoid hemorrhages (SAHs) between 1990 and 2019 in the United States.
  • Researchers focused on both overall and age-standardized estimates, stroke incidence, prevalence, mortality, and DALYs per 100,000 people.

TAKEAWAY:

  • In 2019, the United States recorded 7.09 million prevalent strokes, 83% of which were ischemic and 57% of which occurred in women.
  • The absolute numbers of stroke cases, mortality, and DALYs increased from 1990 to 2019, but the age-standardized rates either declined or remained steady.
  • Overall incidence increased by 40% for ICH, 51% for SAH, and 13% for , and stroke mortality increased by 56% for ICH, 72% for SAH, and 5.4% for ischemic stroke.
  • Age-adjusted analyses showed the results were not uniform across all geographical areas, with older adults (ages, 50-74 years) experiencing decreased incidence in coastal areas and younger individuals (ages, 15-49 years) experiencing an uptick in the South and Midwest United States.

IN PRACTICE:

“As the country prepares for an imminent swell in the aging population, coupled with a noticeable plateau in advancements against stroke mortality, it becomes evident that future directions must focus on a multipronged strategy,” the authors wrote. “This involves both embracing precision medicine’s potential and fortifying widespread public health campaigns.”

SOURCE:

Kevin N. Sheth, MD, of the Yale Center for Brain and Mind Health, Yale School of Medicine, New Haven, Connecticut, was the senior and corresponding author of the study. It was published online in JAMA Neurology.

LIMITATIONS:

The accuracy of stroke ascertainment was limited by the data source, which may be prone to misclassification. The data lacked detailed information on race, ethnicity, and stroke characteristics other than stroke type.

DISCLOSURES:

This work was funded by the Bill and Melinda Gates Foundation, the American Heart Association Medical Student Research Fellowship, grants from the National Institutes of Health, the American Heart Association, the Yale Pepper Scholar Award, and the Neurocritical Care Society Research fellowship. Sheth reported receiving grants from the National Institutes of Health, American Heart Association, and Hyperfine; personal fees/monitoring board fees/equity from Astrocyte, CSL Behring, Zoll, Sense, Bexorg, Rhaeos, and Alva and having a patent for Alva licensed. The other authors’ disclosures are listed in the original paper.

A version of this article appeared on Medscape.com.

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TOPLINE:

Age-standardized stroke rates decreased in the United States between 1990 and 2019, while absolute stroke incidence, prevalence, mortality, and disability-adjusted life years (DALYs) rates increased, a new study showed. Investigators noted the findings, which also show a significant increase in hemorrhagic stroke and an uptick in stroke among adults under 50 years in the South and Midwest, suggesting a significant shift in the US stroke burden.

METHODOLOGY:

  • This in-depth, cross-sectional analysis of the 2019 Global Burden of Disease study included data on all-cause and ischemic strokes, intracerebral hemorrhages (ICHs), and subarachnoid hemorrhages (SAHs) between 1990 and 2019 in the United States.
  • Researchers focused on both overall and age-standardized estimates, stroke incidence, prevalence, mortality, and DALYs per 100,000 people.

TAKEAWAY:

  • In 2019, the United States recorded 7.09 million prevalent strokes, 83% of which were ischemic and 57% of which occurred in women.
  • The absolute numbers of stroke cases, mortality, and DALYs increased from 1990 to 2019, but the age-standardized rates either declined or remained steady.
  • Overall incidence increased by 40% for ICH, 51% for SAH, and 13% for , and stroke mortality increased by 56% for ICH, 72% for SAH, and 5.4% for ischemic stroke.
  • Age-adjusted analyses showed the results were not uniform across all geographical areas, with older adults (ages, 50-74 years) experiencing decreased incidence in coastal areas and younger individuals (ages, 15-49 years) experiencing an uptick in the South and Midwest United States.

IN PRACTICE:

“As the country prepares for an imminent swell in the aging population, coupled with a noticeable plateau in advancements against stroke mortality, it becomes evident that future directions must focus on a multipronged strategy,” the authors wrote. “This involves both embracing precision medicine’s potential and fortifying widespread public health campaigns.”

SOURCE:

Kevin N. Sheth, MD, of the Yale Center for Brain and Mind Health, Yale School of Medicine, New Haven, Connecticut, was the senior and corresponding author of the study. It was published online in JAMA Neurology.

LIMITATIONS:

The accuracy of stroke ascertainment was limited by the data source, which may be prone to misclassification. The data lacked detailed information on race, ethnicity, and stroke characteristics other than stroke type.

DISCLOSURES:

This work was funded by the Bill and Melinda Gates Foundation, the American Heart Association Medical Student Research Fellowship, grants from the National Institutes of Health, the American Heart Association, the Yale Pepper Scholar Award, and the Neurocritical Care Society Research fellowship. Sheth reported receiving grants from the National Institutes of Health, American Heart Association, and Hyperfine; personal fees/monitoring board fees/equity from Astrocyte, CSL Behring, Zoll, Sense, Bexorg, Rhaeos, and Alva and having a patent for Alva licensed. The other authors’ disclosures are listed in the original paper.

A version of this article appeared on Medscape.com.

 

TOPLINE:

Age-standardized stroke rates decreased in the United States between 1990 and 2019, while absolute stroke incidence, prevalence, mortality, and disability-adjusted life years (DALYs) rates increased, a new study showed. Investigators noted the findings, which also show a significant increase in hemorrhagic stroke and an uptick in stroke among adults under 50 years in the South and Midwest, suggesting a significant shift in the US stroke burden.

METHODOLOGY:

  • This in-depth, cross-sectional analysis of the 2019 Global Burden of Disease study included data on all-cause and ischemic strokes, intracerebral hemorrhages (ICHs), and subarachnoid hemorrhages (SAHs) between 1990 and 2019 in the United States.
  • Researchers focused on both overall and age-standardized estimates, stroke incidence, prevalence, mortality, and DALYs per 100,000 people.

TAKEAWAY:

  • In 2019, the United States recorded 7.09 million prevalent strokes, 83% of which were ischemic and 57% of which occurred in women.
  • The absolute numbers of stroke cases, mortality, and DALYs increased from 1990 to 2019, but the age-standardized rates either declined or remained steady.
  • Overall incidence increased by 40% for ICH, 51% for SAH, and 13% for , and stroke mortality increased by 56% for ICH, 72% for SAH, and 5.4% for ischemic stroke.
  • Age-adjusted analyses showed the results were not uniform across all geographical areas, with older adults (ages, 50-74 years) experiencing decreased incidence in coastal areas and younger individuals (ages, 15-49 years) experiencing an uptick in the South and Midwest United States.

IN PRACTICE:

“As the country prepares for an imminent swell in the aging population, coupled with a noticeable plateau in advancements against stroke mortality, it becomes evident that future directions must focus on a multipronged strategy,” the authors wrote. “This involves both embracing precision medicine’s potential and fortifying widespread public health campaigns.”

SOURCE:

Kevin N. Sheth, MD, of the Yale Center for Brain and Mind Health, Yale School of Medicine, New Haven, Connecticut, was the senior and corresponding author of the study. It was published online in JAMA Neurology.

LIMITATIONS:

The accuracy of stroke ascertainment was limited by the data source, which may be prone to misclassification. The data lacked detailed information on race, ethnicity, and stroke characteristics other than stroke type.

DISCLOSURES:

This work was funded by the Bill and Melinda Gates Foundation, the American Heart Association Medical Student Research Fellowship, grants from the National Institutes of Health, the American Heart Association, the Yale Pepper Scholar Award, and the Neurocritical Care Society Research fellowship. Sheth reported receiving grants from the National Institutes of Health, American Heart Association, and Hyperfine; personal fees/monitoring board fees/equity from Astrocyte, CSL Behring, Zoll, Sense, Bexorg, Rhaeos, and Alva and having a patent for Alva licensed. The other authors’ disclosures are listed in the original paper.

A version of this article appeared on Medscape.com.

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Understanding and Promoting Compassion in Medicine

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In most Western countries, professional standards dictate that physicians should practice medicine with compassion. Patients also expect compassionate care from physicians because it represents a model capable of providing greater patient satisfaction, fostering better doctor-patient relationships, and enabling better psychological states among patients.

The etymology of the term “compassion” derives from the Latin roots “com,” meaning “together with,” and “pati,” meaning “to endure or suffer.” When discussing compassion, it is necessary to distinguish it from empathy, a term generally used to refer to cognitive or emotional processes in which the perspective of the other (in this case, the patient) is taken. Compassion implies or requires empathy and includes the desire to help or alleviate the suffering of others. Compassion in the medical context is likely a specific instance of a more complex adaptive system that has evolved, not only among humans, to motivate recognition and assistance when others suffer.
 

Compassion Fatigue

Physicians’ compassion is expected by patients and the profession. It is fundamental for effective clinical practice. Although compassion is central to medical practice, most research related to the topic has focused on “compassion fatigue,” which is understood as a specific type of professional burnout, as if physicians had a limited reserve of compassion that dwindles or becomes exhausted with use or overuse. This is one aspect of a much more complex problem, in which compassion represents the endpoint of a dynamic process that encompasses the influences of the physician, the patient, the clinic, and the institution.

Compassion Capacity: Conditioning Factors

Chronic exposure of physicians to conflicting work demands may be associated with the depletion of their psychological resources and, consequently, emotional and cognitive fatigue that can contribute to poorer work outcomes, including the ability to express compassion.

Rates of professional burnout in medicine are increasing. The driving factors of this phenomenon are largely rooted in organizations and healthcare systems and include excessive workloads, inefficient work processes, administrative burdens, and lack of input or control by physicians regarding issues concerning their work life. The outcome often is early retirement of physicians, a current, increasingly widespread phenomenon and a critical issue not only for the Italian National Health Service but also for other healthcare systems worldwide.
 

Organizational and Personal Values

There is no clear empirical evidence supporting the hypothesis that working in healthcare environments experienced as discrepant with one’s own values has negative effects on key professional outcomes. However, a study published in the Journal of Internal Medicine highlighted the overall negative effect of misalignment between system values and physicians’ personal values, including impaired ability to provide compassionate care, as well as reduced job satisfaction, burnout, absenteeism, and considering the possibility of early retirement. Results from 1000 surveyed professionals indicate that physicians’ subjective competence in providing compassionate care may remain high, but their ability to express it is compromised. From data analysis, the authors hypothesize that when working in environments with discrepant values, occupational contingencies may repeatedly require physicians to set aside their personal values, which can lead them to refrain from using available skills to keep their performance in line with organizational requirements.

These results and hypotheses are not consistent with the notion of compassion fatigue as a reflection of the cost of care resulting from exposure to repeated suffering. Previous evidence shows that expressing compassion in healthcare facilitates greater understanding, suggesting that providing compassion does not impoverish physicians but rather supports them in the effectiveness of interventions and in their satisfaction.

In summary, this study suggests that what prevents compassion is the inability to provide it when hindered by factors related to the situation in which the physician operates. Improving compassion does not simply depend on motivating individual professionals to be more compassionate or on promoting fundamental skills, but probably on the creation of organizational and clinical conditions in which physician compassion can thrive.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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In most Western countries, professional standards dictate that physicians should practice medicine with compassion. Patients also expect compassionate care from physicians because it represents a model capable of providing greater patient satisfaction, fostering better doctor-patient relationships, and enabling better psychological states among patients.

The etymology of the term “compassion” derives from the Latin roots “com,” meaning “together with,” and “pati,” meaning “to endure or suffer.” When discussing compassion, it is necessary to distinguish it from empathy, a term generally used to refer to cognitive or emotional processes in which the perspective of the other (in this case, the patient) is taken. Compassion implies or requires empathy and includes the desire to help or alleviate the suffering of others. Compassion in the medical context is likely a specific instance of a more complex adaptive system that has evolved, not only among humans, to motivate recognition and assistance when others suffer.
 

Compassion Fatigue

Physicians’ compassion is expected by patients and the profession. It is fundamental for effective clinical practice. Although compassion is central to medical practice, most research related to the topic has focused on “compassion fatigue,” which is understood as a specific type of professional burnout, as if physicians had a limited reserve of compassion that dwindles or becomes exhausted with use or overuse. This is one aspect of a much more complex problem, in which compassion represents the endpoint of a dynamic process that encompasses the influences of the physician, the patient, the clinic, and the institution.

Compassion Capacity: Conditioning Factors

Chronic exposure of physicians to conflicting work demands may be associated with the depletion of their psychological resources and, consequently, emotional and cognitive fatigue that can contribute to poorer work outcomes, including the ability to express compassion.

Rates of professional burnout in medicine are increasing. The driving factors of this phenomenon are largely rooted in organizations and healthcare systems and include excessive workloads, inefficient work processes, administrative burdens, and lack of input or control by physicians regarding issues concerning their work life. The outcome often is early retirement of physicians, a current, increasingly widespread phenomenon and a critical issue not only for the Italian National Health Service but also for other healthcare systems worldwide.
 

Organizational and Personal Values

There is no clear empirical evidence supporting the hypothesis that working in healthcare environments experienced as discrepant with one’s own values has negative effects on key professional outcomes. However, a study published in the Journal of Internal Medicine highlighted the overall negative effect of misalignment between system values and physicians’ personal values, including impaired ability to provide compassionate care, as well as reduced job satisfaction, burnout, absenteeism, and considering the possibility of early retirement. Results from 1000 surveyed professionals indicate that physicians’ subjective competence in providing compassionate care may remain high, but their ability to express it is compromised. From data analysis, the authors hypothesize that when working in environments with discrepant values, occupational contingencies may repeatedly require physicians to set aside their personal values, which can lead them to refrain from using available skills to keep their performance in line with organizational requirements.

These results and hypotheses are not consistent with the notion of compassion fatigue as a reflection of the cost of care resulting from exposure to repeated suffering. Previous evidence shows that expressing compassion in healthcare facilitates greater understanding, suggesting that providing compassion does not impoverish physicians but rather supports them in the effectiveness of interventions and in their satisfaction.

In summary, this study suggests that what prevents compassion is the inability to provide it when hindered by factors related to the situation in which the physician operates. Improving compassion does not simply depend on motivating individual professionals to be more compassionate or on promoting fundamental skills, but probably on the creation of organizational and clinical conditions in which physician compassion can thrive.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

In most Western countries, professional standards dictate that physicians should practice medicine with compassion. Patients also expect compassionate care from physicians because it represents a model capable of providing greater patient satisfaction, fostering better doctor-patient relationships, and enabling better psychological states among patients.

The etymology of the term “compassion” derives from the Latin roots “com,” meaning “together with,” and “pati,” meaning “to endure or suffer.” When discussing compassion, it is necessary to distinguish it from empathy, a term generally used to refer to cognitive or emotional processes in which the perspective of the other (in this case, the patient) is taken. Compassion implies or requires empathy and includes the desire to help or alleviate the suffering of others. Compassion in the medical context is likely a specific instance of a more complex adaptive system that has evolved, not only among humans, to motivate recognition and assistance when others suffer.
 

Compassion Fatigue

Physicians’ compassion is expected by patients and the profession. It is fundamental for effective clinical practice. Although compassion is central to medical practice, most research related to the topic has focused on “compassion fatigue,” which is understood as a specific type of professional burnout, as if physicians had a limited reserve of compassion that dwindles or becomes exhausted with use or overuse. This is one aspect of a much more complex problem, in which compassion represents the endpoint of a dynamic process that encompasses the influences of the physician, the patient, the clinic, and the institution.

Compassion Capacity: Conditioning Factors

Chronic exposure of physicians to conflicting work demands may be associated with the depletion of their psychological resources and, consequently, emotional and cognitive fatigue that can contribute to poorer work outcomes, including the ability to express compassion.

Rates of professional burnout in medicine are increasing. The driving factors of this phenomenon are largely rooted in organizations and healthcare systems and include excessive workloads, inefficient work processes, administrative burdens, and lack of input or control by physicians regarding issues concerning their work life. The outcome often is early retirement of physicians, a current, increasingly widespread phenomenon and a critical issue not only for the Italian National Health Service but also for other healthcare systems worldwide.
 

Organizational and Personal Values

There is no clear empirical evidence supporting the hypothesis that working in healthcare environments experienced as discrepant with one’s own values has negative effects on key professional outcomes. However, a study published in the Journal of Internal Medicine highlighted the overall negative effect of misalignment between system values and physicians’ personal values, including impaired ability to provide compassionate care, as well as reduced job satisfaction, burnout, absenteeism, and considering the possibility of early retirement. Results from 1000 surveyed professionals indicate that physicians’ subjective competence in providing compassionate care may remain high, but their ability to express it is compromised. From data analysis, the authors hypothesize that when working in environments with discrepant values, occupational contingencies may repeatedly require physicians to set aside their personal values, which can lead them to refrain from using available skills to keep their performance in line with organizational requirements.

These results and hypotheses are not consistent with the notion of compassion fatigue as a reflection of the cost of care resulting from exposure to repeated suffering. Previous evidence shows that expressing compassion in healthcare facilitates greater understanding, suggesting that providing compassion does not impoverish physicians but rather supports them in the effectiveness of interventions and in their satisfaction.

In summary, this study suggests that what prevents compassion is the inability to provide it when hindered by factors related to the situation in which the physician operates. Improving compassion does not simply depend on motivating individual professionals to be more compassionate or on promoting fundamental skills, but probably on the creation of organizational and clinical conditions in which physician compassion can thrive.

This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

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Human Brains Are Getting Bigger: Good News for Dementia Risk?

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Changed
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The size of the human brain has increased over time, a new finding that may help explain a previously reported decline in incident dementia.

A secular trends analysis using brain imaging data from the long-running Framingham Heart Study revealed an increase in intracranial volume (ICV), cortical gray matter, white matter, and hippocampal volumes, as well as cortical surface area in people born in the 1970s versus those born in the 1930s.

“We hypothesize that the increased size of the brain will lead to increased ‘reserve’ against the diseases of aging, consequently reducing overall risk of dementia,” said Charles DeCarli, MD, director of the Alzheimer’s Disease Research Center and Imaging of Dementia and Aging Laboratory, Department of Neurology and Center for Neuroscience, University of California at Davis.

The study was published online in JAMA Neurology.
 

Dementia Protection?

An earlier report from the Framingham Heart Study suggested that dementia incidence is declining.

“This difference occurred among persons with at least a high school education and was not affected by differences in vascular risk. Our work was stimulated by this finding and the possibility that differences in brain size might be occurring over the three generations of the Framingham Heart Study which might explain an increased resilience to dementia,” said Dr. DeCarli.

The cross-sectional study used data from 3226 Framingham participants (53% women) born in the decades 1930–1970. None had dementia or a history of stroke. At a mean age of 57.7 years, they underwent brain MRI.

Compared with the 1930s birth decade, the 1970s birth decade had a 6.6% greater ICV (1321 mL vs 1234 mL), 7.7% greater white matter volume (476.3 mL vs 441.9 mL), 5.7% greater hippocampal volume (6.69 mL vs 6.51 mL), and 14.9% greater cortical surface area (2222 cm2 vs 1933 cm2).

Cortical thickness was thinner by 21% over the same period, coinciding with larger intracranial volume, cerebral white matter volume, and cortical surface area. 

“We were surprised to find that the brain is getting larger, but the cortex is thinning very slightly. The apparent thinning of the cortex is related to the increased need for expansion of the cortical ribbon. This is based on hypotheses related to the effects of evolution and cortical development designed to make neuronal integration most efficient,” said Dr. DeCarli.

Repeat analysis applied to a subgroup of 1145 individuals of similar age range born in the 1940s (mean age, 60 years) and 1950s (mean age, 59 years) resulted in similar findings.

“These findings likely reflect both secular improvements in early life environmental influences through health, social-cultural, and educational factors, as well as secular improvements in modifiable dementia risk factors leading to better brain health and reserve,” the authors wrote.

While the effects observed are “likely to be small at the level of the individual, they are likely to be substantial at the population level, adding to growing literature that suggests optimized brain development and ideal health through modification of risk factors could substantially modify the effect of common neurodegenerative diseases such as stroke and Alzheiemer’s disease on dementia incidence,” they added.

Limitations included the predominately non-Hispanic White, healthy, and well-educated population that is the Framingham cohort, which is not representative of the broader US population. The cross-sectional nature of the study also limited causal inference. 
 

 

 

Exciting Work 

“If these results are confirmed by others and the observed differences by decade are as large as those reported, it has important implications for aging and dementia studies,” Prashanthi Lemuria, PhD, with Mayo Clinic, Rochester, Minnesota, wrote in an accompanying editorial

“First, studies that use brain charts for the human life span to understand the mechanisms of aging, by stitching together data from individuals across the decades, are significantly overestimating the degree of brain health decline using volumes across the life span because the baseline brain health in individuals who are in their older decades is likely lower to begin with,” Dr. Lemuria noted.

“Second, cortical thickness measurements, often used in dementia studies as a cross-sectional marker for neurodegeneration, showed greatest decline due to secular trends and are not scaled for ICV. Therefore, these should be traded in favor of gray matter volumes after consideration of ICV to estimate the true degree of neurodegeneration,” Dr. Vemuri added.

The data also suggest that longitudinal imaging study designs should be preferred when testing hypotheses on brain health, Dr. Vemuri wrote.

Although this work is “exciting and will bring attention to secular trends in brain health, much work is yet to be done to validate and replicate these findings and, more importantly, understand the mechanistic basis of these trends,” she added. 

“Do these secular trends in improvement of brain health underlie the decrease in dementia risk? The jury may be still out, but the authors are commended for investigating new avenues,” Dr. Vemuri concluded.

Support for this research was provided by the National Institute on Aging and the National Institute on Neurological Disorders and Stroke and the National Institutes of Health. Dr. DeCarli reported serving as a consultant to Novartis on a safety study of heart failure during the conduct of the study and receiving consultant fees from Eisai and Novo Nordisk outside the submitted work. Dr. Lemuria had no disclosures.

A version of this article appeared on Medscape.com.

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The size of the human brain has increased over time, a new finding that may help explain a previously reported decline in incident dementia.

A secular trends analysis using brain imaging data from the long-running Framingham Heart Study revealed an increase in intracranial volume (ICV), cortical gray matter, white matter, and hippocampal volumes, as well as cortical surface area in people born in the 1970s versus those born in the 1930s.

“We hypothesize that the increased size of the brain will lead to increased ‘reserve’ against the diseases of aging, consequently reducing overall risk of dementia,” said Charles DeCarli, MD, director of the Alzheimer’s Disease Research Center and Imaging of Dementia and Aging Laboratory, Department of Neurology and Center for Neuroscience, University of California at Davis.

The study was published online in JAMA Neurology.
 

Dementia Protection?

An earlier report from the Framingham Heart Study suggested that dementia incidence is declining.

“This difference occurred among persons with at least a high school education and was not affected by differences in vascular risk. Our work was stimulated by this finding and the possibility that differences in brain size might be occurring over the three generations of the Framingham Heart Study which might explain an increased resilience to dementia,” said Dr. DeCarli.

The cross-sectional study used data from 3226 Framingham participants (53% women) born in the decades 1930–1970. None had dementia or a history of stroke. At a mean age of 57.7 years, they underwent brain MRI.

Compared with the 1930s birth decade, the 1970s birth decade had a 6.6% greater ICV (1321 mL vs 1234 mL), 7.7% greater white matter volume (476.3 mL vs 441.9 mL), 5.7% greater hippocampal volume (6.69 mL vs 6.51 mL), and 14.9% greater cortical surface area (2222 cm2 vs 1933 cm2).

Cortical thickness was thinner by 21% over the same period, coinciding with larger intracranial volume, cerebral white matter volume, and cortical surface area. 

“We were surprised to find that the brain is getting larger, but the cortex is thinning very slightly. The apparent thinning of the cortex is related to the increased need for expansion of the cortical ribbon. This is based on hypotheses related to the effects of evolution and cortical development designed to make neuronal integration most efficient,” said Dr. DeCarli.

Repeat analysis applied to a subgroup of 1145 individuals of similar age range born in the 1940s (mean age, 60 years) and 1950s (mean age, 59 years) resulted in similar findings.

“These findings likely reflect both secular improvements in early life environmental influences through health, social-cultural, and educational factors, as well as secular improvements in modifiable dementia risk factors leading to better brain health and reserve,” the authors wrote.

While the effects observed are “likely to be small at the level of the individual, they are likely to be substantial at the population level, adding to growing literature that suggests optimized brain development and ideal health through modification of risk factors could substantially modify the effect of common neurodegenerative diseases such as stroke and Alzheiemer’s disease on dementia incidence,” they added.

Limitations included the predominately non-Hispanic White, healthy, and well-educated population that is the Framingham cohort, which is not representative of the broader US population. The cross-sectional nature of the study also limited causal inference. 
 

 

 

Exciting Work 

“If these results are confirmed by others and the observed differences by decade are as large as those reported, it has important implications for aging and dementia studies,” Prashanthi Lemuria, PhD, with Mayo Clinic, Rochester, Minnesota, wrote in an accompanying editorial

“First, studies that use brain charts for the human life span to understand the mechanisms of aging, by stitching together data from individuals across the decades, are significantly overestimating the degree of brain health decline using volumes across the life span because the baseline brain health in individuals who are in their older decades is likely lower to begin with,” Dr. Lemuria noted.

“Second, cortical thickness measurements, often used in dementia studies as a cross-sectional marker for neurodegeneration, showed greatest decline due to secular trends and are not scaled for ICV. Therefore, these should be traded in favor of gray matter volumes after consideration of ICV to estimate the true degree of neurodegeneration,” Dr. Vemuri added.

The data also suggest that longitudinal imaging study designs should be preferred when testing hypotheses on brain health, Dr. Vemuri wrote.

Although this work is “exciting and will bring attention to secular trends in brain health, much work is yet to be done to validate and replicate these findings and, more importantly, understand the mechanistic basis of these trends,” she added. 

“Do these secular trends in improvement of brain health underlie the decrease in dementia risk? The jury may be still out, but the authors are commended for investigating new avenues,” Dr. Vemuri concluded.

Support for this research was provided by the National Institute on Aging and the National Institute on Neurological Disorders and Stroke and the National Institutes of Health. Dr. DeCarli reported serving as a consultant to Novartis on a safety study of heart failure during the conduct of the study and receiving consultant fees from Eisai and Novo Nordisk outside the submitted work. Dr. Lemuria had no disclosures.

A version of this article appeared on Medscape.com.

The size of the human brain has increased over time, a new finding that may help explain a previously reported decline in incident dementia.

A secular trends analysis using brain imaging data from the long-running Framingham Heart Study revealed an increase in intracranial volume (ICV), cortical gray matter, white matter, and hippocampal volumes, as well as cortical surface area in people born in the 1970s versus those born in the 1930s.

“We hypothesize that the increased size of the brain will lead to increased ‘reserve’ against the diseases of aging, consequently reducing overall risk of dementia,” said Charles DeCarli, MD, director of the Alzheimer’s Disease Research Center and Imaging of Dementia and Aging Laboratory, Department of Neurology and Center for Neuroscience, University of California at Davis.

The study was published online in JAMA Neurology.
 

Dementia Protection?

An earlier report from the Framingham Heart Study suggested that dementia incidence is declining.

“This difference occurred among persons with at least a high school education and was not affected by differences in vascular risk. Our work was stimulated by this finding and the possibility that differences in brain size might be occurring over the three generations of the Framingham Heart Study which might explain an increased resilience to dementia,” said Dr. DeCarli.

The cross-sectional study used data from 3226 Framingham participants (53% women) born in the decades 1930–1970. None had dementia or a history of stroke. At a mean age of 57.7 years, they underwent brain MRI.

Compared with the 1930s birth decade, the 1970s birth decade had a 6.6% greater ICV (1321 mL vs 1234 mL), 7.7% greater white matter volume (476.3 mL vs 441.9 mL), 5.7% greater hippocampal volume (6.69 mL vs 6.51 mL), and 14.9% greater cortical surface area (2222 cm2 vs 1933 cm2).

Cortical thickness was thinner by 21% over the same period, coinciding with larger intracranial volume, cerebral white matter volume, and cortical surface area. 

“We were surprised to find that the brain is getting larger, but the cortex is thinning very slightly. The apparent thinning of the cortex is related to the increased need for expansion of the cortical ribbon. This is based on hypotheses related to the effects of evolution and cortical development designed to make neuronal integration most efficient,” said Dr. DeCarli.

Repeat analysis applied to a subgroup of 1145 individuals of similar age range born in the 1940s (mean age, 60 years) and 1950s (mean age, 59 years) resulted in similar findings.

“These findings likely reflect both secular improvements in early life environmental influences through health, social-cultural, and educational factors, as well as secular improvements in modifiable dementia risk factors leading to better brain health and reserve,” the authors wrote.

While the effects observed are “likely to be small at the level of the individual, they are likely to be substantial at the population level, adding to growing literature that suggests optimized brain development and ideal health through modification of risk factors could substantially modify the effect of common neurodegenerative diseases such as stroke and Alzheiemer’s disease on dementia incidence,” they added.

Limitations included the predominately non-Hispanic White, healthy, and well-educated population that is the Framingham cohort, which is not representative of the broader US population. The cross-sectional nature of the study also limited causal inference. 
 

 

 

Exciting Work 

“If these results are confirmed by others and the observed differences by decade are as large as those reported, it has important implications for aging and dementia studies,” Prashanthi Lemuria, PhD, with Mayo Clinic, Rochester, Minnesota, wrote in an accompanying editorial

“First, studies that use brain charts for the human life span to understand the mechanisms of aging, by stitching together data from individuals across the decades, are significantly overestimating the degree of brain health decline using volumes across the life span because the baseline brain health in individuals who are in their older decades is likely lower to begin with,” Dr. Lemuria noted.

“Second, cortical thickness measurements, often used in dementia studies as a cross-sectional marker for neurodegeneration, showed greatest decline due to secular trends and are not scaled for ICV. Therefore, these should be traded in favor of gray matter volumes after consideration of ICV to estimate the true degree of neurodegeneration,” Dr. Vemuri added.

The data also suggest that longitudinal imaging study designs should be preferred when testing hypotheses on brain health, Dr. Vemuri wrote.

Although this work is “exciting and will bring attention to secular trends in brain health, much work is yet to be done to validate and replicate these findings and, more importantly, understand the mechanistic basis of these trends,” she added. 

“Do these secular trends in improvement of brain health underlie the decrease in dementia risk? The jury may be still out, but the authors are commended for investigating new avenues,” Dr. Vemuri concluded.

Support for this research was provided by the National Institute on Aging and the National Institute on Neurological Disorders and Stroke and the National Institutes of Health. Dr. DeCarli reported serving as a consultant to Novartis on a safety study of heart failure during the conduct of the study and receiving consultant fees from Eisai and Novo Nordisk outside the submitted work. Dr. Lemuria had no disclosures.

A version of this article appeared on Medscape.com.

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Most Disadvantaged Least Likely to Receive Thrombolysis

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Wed, 03/27/2024 - 12:40

Black people, men, older adults, and those living in rural communities are less likely to receive thrombolytic therapy after ischemic stroke, early research shows.

“The findings should serve as an eye-opener that social determinants of health seem to be playing a role in who receives thrombolytic therapy, said study investigator Chanaka Kahathuduwa, MD, PhD, resident physician, Department of Neurology, School of Medicine, Texas Tech University Health Sciences Center, Lubbock. 

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
 

Contributor to Poor Outcomes

Social determinants of health are important contributors to poor stroke-related outcomes, the investigators noted. They pointed out that previous research has yielded conflicting results as to the cause.

Whereas some studies suggest poor social determinants of health drive increased stroke incidence, others raise the question of whether there are disparities in acute stroke care. 

To investigate, the researchers used a publicly available database and diagnostic and procedure codes to identify patients presenting at emergency departments in Texas from 2016 to 2019 with ischemic stroke who did and did not receive thrombolytic therapy.

“We focused on Texas, which has a very large area but few places where people have easy access to health care, which is a problem,” said study co-investigator Chathurika Dhanasekara, MD, PhD, research assistant professor in the Department of Surgery, School of Medicine, Texas Tech University Health Sciences Center.

The study included 63,983 stroke patients, of whom 51.6% were female, 66.6% were White, and 17.7% were Black. Of these, 7198 (11.2%) received thrombolytic therapy; such therapies include the tissue plasminogen activators (tPAs) alteplase and tenecteplace.

Researchers collected information on social determinants of health such as age, race, gender, insurance type, and residence based on zip codes. They computed risk ratios (RRs) of administering thrombolysis on the basis of these variables.

Results showed that Black patients were less likely than their White counterparts to receive thrombolysis (RR, 0.90; 95% CI, 0.85-0.96). In addition, patients older than 65 years were less likely those aged 18-45 years to receive thrombolysis (RR, 0.47; 95% CI, 0.44-0.51), and rural residents were less likely than urban dwellers to receive the intervention (RR, 0.60; 95% CI, 0.55-0.65).

It makes some sense, the researchers said, that rural stroke patients would be less likely to get thrombolysis because there’s a limited time window — within 4.5 hours — during which this therapy can be given, and such patients may live a long distance from a hospital.

Two other groups less likely to receive thrombolysis were Hispanic persons versus non-Hispanic persons (RR, 0.93; 95% CI, 0.87-0.98) and Medicare/Medicaid/Veterans Administration patients (RR, 0.77; 95% CI, 0.73-0.81) or uninsured patients (RR, 0.90; 95% CI, 0.94-0.87) vs those with private insurance.

Interestingly, male patients were less likely than female patients to receive thrombolysis (RR, 0.95; 95% CI, 0.90-0.99).
 

Surprising Findings

With the exception of the discrepancy in thrombolysis rates between rural versus urban dwellers, the study’s findings were surprising, said Dr. Kahathuduwa. 

Researchers divided participants into quartiles, from least to most disadvantaged, based on the Social Vulnerability Index (SVI), created by the Centers for Disease Control and Prevention to determine social vulnerability or factors that can negatively affect a community’s health. 

Among the 7930 individuals in the least disadvantaged group, 1037 received thrombolysis. In comparison, among the 7966 persons in the most disadvantaged group, 964 received thrombolysis.

After adjusting for age, sex, and education, investigators found that patients in the first quartile based on SVI were more likely to be associated with thrombolysis vs those in the second and third quartiles (RR, 1.13; 95% CI, 1.04-1.22).

The researchers also examined the impact of comorbidities using the Charlson Comorbidity Index. Patients with diabetes, hypertension, and high cholesterol in addition to signs of stroke would rouse a higher degree of suspicion and be more likely to be treated with tPA or tenecteplase, said Dr. Kahathuduwa.

“But even when we controlled for those comorbidities, the relationships we identified between health disparities and the likelihood of receiving thrombolysis remained the same,” said Dr. Kahathuduwa.

It’s not clear from this study what factors contribute to the disparities in stroke treatment. “All we know is these relationships exist,” said Dr. Kahathuduwa. “We should use this as a foundation to understand what’s really going on at the grassroots level.”

However, he added, it’s possible that accessibility plays a role. He noted that Lubbock has the only Level 1 stroke center in west Texas; most stroke centers in the state are concentrated in cities in east and central Texas.

The investigators are embarking on further research to assess the impact of determinants of health on receipt of endovascular therapy and the role of stroke severity.

“In an ideal world, all patients who need thrombolytic therapy would get thrombolytic therapy within the recommended time window because the benefits are very clear,” said Dr. Kahathuduwa.

The findings may not be generalizable because they come from a single database. “Our findings need to be validated in another independent dataset before we can confidently determine what’s going on,” said Dr. Kahathuduwa.

A limitation of the study was that it is unknown how many of the participants were seen at the hospital within the recommended time frame and would thus be eligible to receive the treatment.

Commenting on the research, Martinson Arnan, MD , a vascular neurologist at Bronson Neuroscience Center, Kalamazoo, Michigan, said the study’s “exploratory finding” is important and “illuminates the potential impact of social determinants of health on disparities in acute stroke treatment.”

Neurologists consistently emphasize the principle that “time is brain” — that timely restoration of blood flow is crucial for minimizing morbidity associated with ischemic stroke. This study offers a potential opportunity to investigate how social determinants of health may affect stroke care, said Dr. Arnan.

However, he added, further research is needed “to understand whether the differences in outcomes observed here are influenced by levels of health education, concordance between patients and their treating providers, or other issues related to access barriers.” 

The investigators and Dr. Arnan report no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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Black people, men, older adults, and those living in rural communities are less likely to receive thrombolytic therapy after ischemic stroke, early research shows.

“The findings should serve as an eye-opener that social determinants of health seem to be playing a role in who receives thrombolytic therapy, said study investigator Chanaka Kahathuduwa, MD, PhD, resident physician, Department of Neurology, School of Medicine, Texas Tech University Health Sciences Center, Lubbock. 

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
 

Contributor to Poor Outcomes

Social determinants of health are important contributors to poor stroke-related outcomes, the investigators noted. They pointed out that previous research has yielded conflicting results as to the cause.

Whereas some studies suggest poor social determinants of health drive increased stroke incidence, others raise the question of whether there are disparities in acute stroke care. 

To investigate, the researchers used a publicly available database and diagnostic and procedure codes to identify patients presenting at emergency departments in Texas from 2016 to 2019 with ischemic stroke who did and did not receive thrombolytic therapy.

“We focused on Texas, which has a very large area but few places where people have easy access to health care, which is a problem,” said study co-investigator Chathurika Dhanasekara, MD, PhD, research assistant professor in the Department of Surgery, School of Medicine, Texas Tech University Health Sciences Center.

The study included 63,983 stroke patients, of whom 51.6% were female, 66.6% were White, and 17.7% were Black. Of these, 7198 (11.2%) received thrombolytic therapy; such therapies include the tissue plasminogen activators (tPAs) alteplase and tenecteplace.

Researchers collected information on social determinants of health such as age, race, gender, insurance type, and residence based on zip codes. They computed risk ratios (RRs) of administering thrombolysis on the basis of these variables.

Results showed that Black patients were less likely than their White counterparts to receive thrombolysis (RR, 0.90; 95% CI, 0.85-0.96). In addition, patients older than 65 years were less likely those aged 18-45 years to receive thrombolysis (RR, 0.47; 95% CI, 0.44-0.51), and rural residents were less likely than urban dwellers to receive the intervention (RR, 0.60; 95% CI, 0.55-0.65).

It makes some sense, the researchers said, that rural stroke patients would be less likely to get thrombolysis because there’s a limited time window — within 4.5 hours — during which this therapy can be given, and such patients may live a long distance from a hospital.

Two other groups less likely to receive thrombolysis were Hispanic persons versus non-Hispanic persons (RR, 0.93; 95% CI, 0.87-0.98) and Medicare/Medicaid/Veterans Administration patients (RR, 0.77; 95% CI, 0.73-0.81) or uninsured patients (RR, 0.90; 95% CI, 0.94-0.87) vs those with private insurance.

Interestingly, male patients were less likely than female patients to receive thrombolysis (RR, 0.95; 95% CI, 0.90-0.99).
 

Surprising Findings

With the exception of the discrepancy in thrombolysis rates between rural versus urban dwellers, the study’s findings were surprising, said Dr. Kahathuduwa. 

Researchers divided participants into quartiles, from least to most disadvantaged, based on the Social Vulnerability Index (SVI), created by the Centers for Disease Control and Prevention to determine social vulnerability or factors that can negatively affect a community’s health. 

Among the 7930 individuals in the least disadvantaged group, 1037 received thrombolysis. In comparison, among the 7966 persons in the most disadvantaged group, 964 received thrombolysis.

After adjusting for age, sex, and education, investigators found that patients in the first quartile based on SVI were more likely to be associated with thrombolysis vs those in the second and third quartiles (RR, 1.13; 95% CI, 1.04-1.22).

The researchers also examined the impact of comorbidities using the Charlson Comorbidity Index. Patients with diabetes, hypertension, and high cholesterol in addition to signs of stroke would rouse a higher degree of suspicion and be more likely to be treated with tPA or tenecteplase, said Dr. Kahathuduwa.

“But even when we controlled for those comorbidities, the relationships we identified between health disparities and the likelihood of receiving thrombolysis remained the same,” said Dr. Kahathuduwa.

It’s not clear from this study what factors contribute to the disparities in stroke treatment. “All we know is these relationships exist,” said Dr. Kahathuduwa. “We should use this as a foundation to understand what’s really going on at the grassroots level.”

However, he added, it’s possible that accessibility plays a role. He noted that Lubbock has the only Level 1 stroke center in west Texas; most stroke centers in the state are concentrated in cities in east and central Texas.

The investigators are embarking on further research to assess the impact of determinants of health on receipt of endovascular therapy and the role of stroke severity.

“In an ideal world, all patients who need thrombolytic therapy would get thrombolytic therapy within the recommended time window because the benefits are very clear,” said Dr. Kahathuduwa.

The findings may not be generalizable because they come from a single database. “Our findings need to be validated in another independent dataset before we can confidently determine what’s going on,” said Dr. Kahathuduwa.

A limitation of the study was that it is unknown how many of the participants were seen at the hospital within the recommended time frame and would thus be eligible to receive the treatment.

Commenting on the research, Martinson Arnan, MD , a vascular neurologist at Bronson Neuroscience Center, Kalamazoo, Michigan, said the study’s “exploratory finding” is important and “illuminates the potential impact of social determinants of health on disparities in acute stroke treatment.”

Neurologists consistently emphasize the principle that “time is brain” — that timely restoration of blood flow is crucial for minimizing morbidity associated with ischemic stroke. This study offers a potential opportunity to investigate how social determinants of health may affect stroke care, said Dr. Arnan.

However, he added, further research is needed “to understand whether the differences in outcomes observed here are influenced by levels of health education, concordance between patients and their treating providers, or other issues related to access barriers.” 

The investigators and Dr. Arnan report no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Black people, men, older adults, and those living in rural communities are less likely to receive thrombolytic therapy after ischemic stroke, early research shows.

“The findings should serve as an eye-opener that social determinants of health seem to be playing a role in who receives thrombolytic therapy, said study investigator Chanaka Kahathuduwa, MD, PhD, resident physician, Department of Neurology, School of Medicine, Texas Tech University Health Sciences Center, Lubbock. 

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
 

Contributor to Poor Outcomes

Social determinants of health are important contributors to poor stroke-related outcomes, the investigators noted. They pointed out that previous research has yielded conflicting results as to the cause.

Whereas some studies suggest poor social determinants of health drive increased stroke incidence, others raise the question of whether there are disparities in acute stroke care. 

To investigate, the researchers used a publicly available database and diagnostic and procedure codes to identify patients presenting at emergency departments in Texas from 2016 to 2019 with ischemic stroke who did and did not receive thrombolytic therapy.

“We focused on Texas, which has a very large area but few places where people have easy access to health care, which is a problem,” said study co-investigator Chathurika Dhanasekara, MD, PhD, research assistant professor in the Department of Surgery, School of Medicine, Texas Tech University Health Sciences Center.

The study included 63,983 stroke patients, of whom 51.6% were female, 66.6% were White, and 17.7% were Black. Of these, 7198 (11.2%) received thrombolytic therapy; such therapies include the tissue plasminogen activators (tPAs) alteplase and tenecteplace.

Researchers collected information on social determinants of health such as age, race, gender, insurance type, and residence based on zip codes. They computed risk ratios (RRs) of administering thrombolysis on the basis of these variables.

Results showed that Black patients were less likely than their White counterparts to receive thrombolysis (RR, 0.90; 95% CI, 0.85-0.96). In addition, patients older than 65 years were less likely those aged 18-45 years to receive thrombolysis (RR, 0.47; 95% CI, 0.44-0.51), and rural residents were less likely than urban dwellers to receive the intervention (RR, 0.60; 95% CI, 0.55-0.65).

It makes some sense, the researchers said, that rural stroke patients would be less likely to get thrombolysis because there’s a limited time window — within 4.5 hours — during which this therapy can be given, and such patients may live a long distance from a hospital.

Two other groups less likely to receive thrombolysis were Hispanic persons versus non-Hispanic persons (RR, 0.93; 95% CI, 0.87-0.98) and Medicare/Medicaid/Veterans Administration patients (RR, 0.77; 95% CI, 0.73-0.81) or uninsured patients (RR, 0.90; 95% CI, 0.94-0.87) vs those with private insurance.

Interestingly, male patients were less likely than female patients to receive thrombolysis (RR, 0.95; 95% CI, 0.90-0.99).
 

Surprising Findings

With the exception of the discrepancy in thrombolysis rates between rural versus urban dwellers, the study’s findings were surprising, said Dr. Kahathuduwa. 

Researchers divided participants into quartiles, from least to most disadvantaged, based on the Social Vulnerability Index (SVI), created by the Centers for Disease Control and Prevention to determine social vulnerability or factors that can negatively affect a community’s health. 

Among the 7930 individuals in the least disadvantaged group, 1037 received thrombolysis. In comparison, among the 7966 persons in the most disadvantaged group, 964 received thrombolysis.

After adjusting for age, sex, and education, investigators found that patients in the first quartile based on SVI were more likely to be associated with thrombolysis vs those in the second and third quartiles (RR, 1.13; 95% CI, 1.04-1.22).

The researchers also examined the impact of comorbidities using the Charlson Comorbidity Index. Patients with diabetes, hypertension, and high cholesterol in addition to signs of stroke would rouse a higher degree of suspicion and be more likely to be treated with tPA or tenecteplase, said Dr. Kahathuduwa.

“But even when we controlled for those comorbidities, the relationships we identified between health disparities and the likelihood of receiving thrombolysis remained the same,” said Dr. Kahathuduwa.

It’s not clear from this study what factors contribute to the disparities in stroke treatment. “All we know is these relationships exist,” said Dr. Kahathuduwa. “We should use this as a foundation to understand what’s really going on at the grassroots level.”

However, he added, it’s possible that accessibility plays a role. He noted that Lubbock has the only Level 1 stroke center in west Texas; most stroke centers in the state are concentrated in cities in east and central Texas.

The investigators are embarking on further research to assess the impact of determinants of health on receipt of endovascular therapy and the role of stroke severity.

“In an ideal world, all patients who need thrombolytic therapy would get thrombolytic therapy within the recommended time window because the benefits are very clear,” said Dr. Kahathuduwa.

The findings may not be generalizable because they come from a single database. “Our findings need to be validated in another independent dataset before we can confidently determine what’s going on,” said Dr. Kahathuduwa.

A limitation of the study was that it is unknown how many of the participants were seen at the hospital within the recommended time frame and would thus be eligible to receive the treatment.

Commenting on the research, Martinson Arnan, MD , a vascular neurologist at Bronson Neuroscience Center, Kalamazoo, Michigan, said the study’s “exploratory finding” is important and “illuminates the potential impact of social determinants of health on disparities in acute stroke treatment.”

Neurologists consistently emphasize the principle that “time is brain” — that timely restoration of blood flow is crucial for minimizing morbidity associated with ischemic stroke. This study offers a potential opportunity to investigate how social determinants of health may affect stroke care, said Dr. Arnan.

However, he added, further research is needed “to understand whether the differences in outcomes observed here are influenced by levels of health education, concordance between patients and their treating providers, or other issues related to access barriers.” 

The investigators and Dr. Arnan report no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

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Infant Exposure to MS Drugs via Breastfeeding: New Data

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Wed, 03/27/2024 - 12:36

Breastfeeding by women with multiple sclerosis (MS) or neuromyelitis optica spectrum disorder (NMOSD) who are taking monoclonal antibodies (mAbs) appears to be safe for infants, new research confirmed.

Registry data showed no differences in health or development in the first 3 years of life among infants exposed to natalizumab, ocrelizumab, rituximab, or ofatumumab, compared with unexposed infants.

“Most monoclonal antibody medications for multiple sclerosis are not currently approved for use while a mother is breastfeeding,” even though the disease can develop during a person’s reproductive years, study investigator Kerstin Hellwig, MD, with Ruhr University in Bochum, Germany, said in a news release.

“Our data show infants exposed to these medications through breastfeeding experienced no negative effects on health or development within the first 3 years of life,” Dr. Hellwig said.

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
 

Registry Data and Analysis

Using the German MS and Pregnancy Registry, researchers identified 183 infants born to mothers taking mAbs while breastfeeding — 180 with a diagnosis of MS and three with a diagnosis of NMOSD. The infants were matched to 183 unexposed infants (control group).

Exposure to mAbs during lactation started a median of 19 days postpartum and lasted for a median of 172 days. The most commonly used mAb during lactation was natalizumab (125 women), followed by ocrelizumab (34 women), rituximab (11 women), and ofatumumab (10 women).

Among the entire infant cohort, two were first exposed to natalizumab and then ocrelizumab; one was exposed to rituximab and then ocrelizumab; three had been previously breastfed on glatiramer acetate and two on interferons.

The primary outcomes were hospitalizations, antibiotic use, developmental delay, and weight during the first 3 years of life in mAb-exposed versus unexposed infants.

In adjusted regression analyses, mAb exposure during breastfeeding was not significantly associated with annual hospitalization (rate ratio [RR], 1.23; P = .473), annual systemic antibiotic use (RR, 1.55; P = .093), developmental delay (odds ratio, 1.16; P = .716), or weight.

A limitation of the study was that only about a third of the infants were followed for the full 3 years. Therefore, Dr. Hellwig said, the results for the third year of life are less meaningful than for years 1 and 2.
 

‘Reassuring’ Data

Reached for comment, Edith L. Graham, MD, Department of Neurology, Multiple Sclerosis and Neuroimmunology, Northwestern University, Chicago, Illinois, noted that this is the largest group of breastfed infants exposed to mAbs used to treat MS and said the data provide “reassuring infant outcomes with no increase in hospitalization, antibiotic use, or developmental delay.”

Dr. Graham noted that recent publications have reported more on the use of anti-CD20 mAbs (ocrelizumab/rituximab/ofatumumab) while breastfeeding, “and this study adds data for patients on natalizumab.”

“It will be important to know how infusion timing after birth impacts transfer of monoclonal antibodies depending on the milk stage as it transitions from colostrum to mature milk in the first month postpartum,” Dr. Graham said.

“While infection rates of infants are reassuring, data on allergies in the exposed infants would be interesting to look at as well,” she added. “While these infusions are not orally bioavailable, we do not know the full extent of impact on the neonatal gut microbiome.”

In addition, Dr. Graham said it would be important to know whether drugs administered monthly, such as natalizumab and ofatumumab, accumulate in the breast milk at higher levels than medications such as ocrelizumab and rituximab, which are administered twice a year.

The German MS and pregnancy registry was partly supported by the Innovation Fund of the Federal Joint Committee, Almirall Hermal GmbH, Biogen GmbH Germany, Hexal AG, Merck Serono GmbH, Novartis Pharma GmbH, Roche Deutschland GmbH, Sanofi Genzyme, and Teva GmbH. Dr. Hellwig and Dr. Graham had no relevant disclosures.

A version of this article appeared on Medscape.com.

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Breastfeeding by women with multiple sclerosis (MS) or neuromyelitis optica spectrum disorder (NMOSD) who are taking monoclonal antibodies (mAbs) appears to be safe for infants, new research confirmed.

Registry data showed no differences in health or development in the first 3 years of life among infants exposed to natalizumab, ocrelizumab, rituximab, or ofatumumab, compared with unexposed infants.

“Most monoclonal antibody medications for multiple sclerosis are not currently approved for use while a mother is breastfeeding,” even though the disease can develop during a person’s reproductive years, study investigator Kerstin Hellwig, MD, with Ruhr University in Bochum, Germany, said in a news release.

“Our data show infants exposed to these medications through breastfeeding experienced no negative effects on health or development within the first 3 years of life,” Dr. Hellwig said.

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
 

Registry Data and Analysis

Using the German MS and Pregnancy Registry, researchers identified 183 infants born to mothers taking mAbs while breastfeeding — 180 with a diagnosis of MS and three with a diagnosis of NMOSD. The infants were matched to 183 unexposed infants (control group).

Exposure to mAbs during lactation started a median of 19 days postpartum and lasted for a median of 172 days. The most commonly used mAb during lactation was natalizumab (125 women), followed by ocrelizumab (34 women), rituximab (11 women), and ofatumumab (10 women).

Among the entire infant cohort, two were first exposed to natalizumab and then ocrelizumab; one was exposed to rituximab and then ocrelizumab; three had been previously breastfed on glatiramer acetate and two on interferons.

The primary outcomes were hospitalizations, antibiotic use, developmental delay, and weight during the first 3 years of life in mAb-exposed versus unexposed infants.

In adjusted regression analyses, mAb exposure during breastfeeding was not significantly associated with annual hospitalization (rate ratio [RR], 1.23; P = .473), annual systemic antibiotic use (RR, 1.55; P = .093), developmental delay (odds ratio, 1.16; P = .716), or weight.

A limitation of the study was that only about a third of the infants were followed for the full 3 years. Therefore, Dr. Hellwig said, the results for the third year of life are less meaningful than for years 1 and 2.
 

‘Reassuring’ Data

Reached for comment, Edith L. Graham, MD, Department of Neurology, Multiple Sclerosis and Neuroimmunology, Northwestern University, Chicago, Illinois, noted that this is the largest group of breastfed infants exposed to mAbs used to treat MS and said the data provide “reassuring infant outcomes with no increase in hospitalization, antibiotic use, or developmental delay.”

Dr. Graham noted that recent publications have reported more on the use of anti-CD20 mAbs (ocrelizumab/rituximab/ofatumumab) while breastfeeding, “and this study adds data for patients on natalizumab.”

“It will be important to know how infusion timing after birth impacts transfer of monoclonal antibodies depending on the milk stage as it transitions from colostrum to mature milk in the first month postpartum,” Dr. Graham said.

“While infection rates of infants are reassuring, data on allergies in the exposed infants would be interesting to look at as well,” she added. “While these infusions are not orally bioavailable, we do not know the full extent of impact on the neonatal gut microbiome.”

In addition, Dr. Graham said it would be important to know whether drugs administered monthly, such as natalizumab and ofatumumab, accumulate in the breast milk at higher levels than medications such as ocrelizumab and rituximab, which are administered twice a year.

The German MS and pregnancy registry was partly supported by the Innovation Fund of the Federal Joint Committee, Almirall Hermal GmbH, Biogen GmbH Germany, Hexal AG, Merck Serono GmbH, Novartis Pharma GmbH, Roche Deutschland GmbH, Sanofi Genzyme, and Teva GmbH. Dr. Hellwig and Dr. Graham had no relevant disclosures.

A version of this article appeared on Medscape.com.

Breastfeeding by women with multiple sclerosis (MS) or neuromyelitis optica spectrum disorder (NMOSD) who are taking monoclonal antibodies (mAbs) appears to be safe for infants, new research confirmed.

Registry data showed no differences in health or development in the first 3 years of life among infants exposed to natalizumab, ocrelizumab, rituximab, or ofatumumab, compared with unexposed infants.

“Most monoclonal antibody medications for multiple sclerosis are not currently approved for use while a mother is breastfeeding,” even though the disease can develop during a person’s reproductive years, study investigator Kerstin Hellwig, MD, with Ruhr University in Bochum, Germany, said in a news release.

“Our data show infants exposed to these medications through breastfeeding experienced no negative effects on health or development within the first 3 years of life,” Dr. Hellwig said.

The findings were released ahead of the study’s scheduled presentation at the annual meeting of the American Academy of Neurology.
 

Registry Data and Analysis

Using the German MS and Pregnancy Registry, researchers identified 183 infants born to mothers taking mAbs while breastfeeding — 180 with a diagnosis of MS and three with a diagnosis of NMOSD. The infants were matched to 183 unexposed infants (control group).

Exposure to mAbs during lactation started a median of 19 days postpartum and lasted for a median of 172 days. The most commonly used mAb during lactation was natalizumab (125 women), followed by ocrelizumab (34 women), rituximab (11 women), and ofatumumab (10 women).

Among the entire infant cohort, two were first exposed to natalizumab and then ocrelizumab; one was exposed to rituximab and then ocrelizumab; three had been previously breastfed on glatiramer acetate and two on interferons.

The primary outcomes were hospitalizations, antibiotic use, developmental delay, and weight during the first 3 years of life in mAb-exposed versus unexposed infants.

In adjusted regression analyses, mAb exposure during breastfeeding was not significantly associated with annual hospitalization (rate ratio [RR], 1.23; P = .473), annual systemic antibiotic use (RR, 1.55; P = .093), developmental delay (odds ratio, 1.16; P = .716), or weight.

A limitation of the study was that only about a third of the infants were followed for the full 3 years. Therefore, Dr. Hellwig said, the results for the third year of life are less meaningful than for years 1 and 2.
 

‘Reassuring’ Data

Reached for comment, Edith L. Graham, MD, Department of Neurology, Multiple Sclerosis and Neuroimmunology, Northwestern University, Chicago, Illinois, noted that this is the largest group of breastfed infants exposed to mAbs used to treat MS and said the data provide “reassuring infant outcomes with no increase in hospitalization, antibiotic use, or developmental delay.”

Dr. Graham noted that recent publications have reported more on the use of anti-CD20 mAbs (ocrelizumab/rituximab/ofatumumab) while breastfeeding, “and this study adds data for patients on natalizumab.”

“It will be important to know how infusion timing after birth impacts transfer of monoclonal antibodies depending on the milk stage as it transitions from colostrum to mature milk in the first month postpartum,” Dr. Graham said.

“While infection rates of infants are reassuring, data on allergies in the exposed infants would be interesting to look at as well,” she added. “While these infusions are not orally bioavailable, we do not know the full extent of impact on the neonatal gut microbiome.”

In addition, Dr. Graham said it would be important to know whether drugs administered monthly, such as natalizumab and ofatumumab, accumulate in the breast milk at higher levels than medications such as ocrelizumab and rituximab, which are administered twice a year.

The German MS and pregnancy registry was partly supported by the Innovation Fund of the Federal Joint Committee, Almirall Hermal GmbH, Biogen GmbH Germany, Hexal AG, Merck Serono GmbH, Novartis Pharma GmbH, Roche Deutschland GmbH, Sanofi Genzyme, and Teva GmbH. Dr. Hellwig and Dr. Graham had no relevant disclosures.

A version of this article appeared on Medscape.com.

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AI for Email Replies? Not Yet

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An article in the March 20 JAMA Network Open looked into the use of AI for responding to patient emails. Basically, they found that this led to a reduction in physician burden, but didn’t save any time.

1. Not sure that’s worth the trouble.

2. Unless the AI is simply responding with something like “message received, thank you” I don’t think this is a good idea.

Yeah, we’re all stretched for time, I understand that. From the starting gun each morning we’re racing between patients, phone calls, incoming test results, staff questions, drug reps, sample closets, dictations, and a million other things.

But AI needs to be a lot better before I let it handle patient questions and concerns.

Someday, yeah, maybe it can do this, like 2-1B, the surgical droid that replaced Luke’s hand in “The Empire Strikes Back.” But we’re not even close to that. Just because a log-in screen says “Jumping to Hyperspace” doesn’t mean you’re on the Millennium Falcon.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block


I generally know my patients, but even if I don’t remember them, I can quickly look up their charts and decide how to answer. AI can look up charts, too, but data is only a part of medicine.

There are a lot of things that don’t make it into a chart: our impressions of people and a knowledge of their personalities and anxieties. We take these into account when responding to their questions. People are different in how things need to be said to them, even if the answer is, overall, the same.

“It’s the AI’s fault” isn’t going to stand up in court, either.

I also have to question the benefit of the findings. If it lessens the “click burden” but still takes the same amount of time, are we really gaining anything?

I’m all for the digital age. In many ways it’s made my practice a lot easier. But I think it has a way to go before I let it start dealing directly with patients.

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

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An article in the March 20 JAMA Network Open looked into the use of AI for responding to patient emails. Basically, they found that this led to a reduction in physician burden, but didn’t save any time.

1. Not sure that’s worth the trouble.

2. Unless the AI is simply responding with something like “message received, thank you” I don’t think this is a good idea.

Yeah, we’re all stretched for time, I understand that. From the starting gun each morning we’re racing between patients, phone calls, incoming test results, staff questions, drug reps, sample closets, dictations, and a million other things.

But AI needs to be a lot better before I let it handle patient questions and concerns.

Someday, yeah, maybe it can do this, like 2-1B, the surgical droid that replaced Luke’s hand in “The Empire Strikes Back.” But we’re not even close to that. Just because a log-in screen says “Jumping to Hyperspace” doesn’t mean you’re on the Millennium Falcon.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block


I generally know my patients, but even if I don’t remember them, I can quickly look up their charts and decide how to answer. AI can look up charts, too, but data is only a part of medicine.

There are a lot of things that don’t make it into a chart: our impressions of people and a knowledge of their personalities and anxieties. We take these into account when responding to their questions. People are different in how things need to be said to them, even if the answer is, overall, the same.

“It’s the AI’s fault” isn’t going to stand up in court, either.

I also have to question the benefit of the findings. If it lessens the “click burden” but still takes the same amount of time, are we really gaining anything?

I’m all for the digital age. In many ways it’s made my practice a lot easier. But I think it has a way to go before I let it start dealing directly with patients.

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

An article in the March 20 JAMA Network Open looked into the use of AI for responding to patient emails. Basically, they found that this led to a reduction in physician burden, but didn’t save any time.

1. Not sure that’s worth the trouble.

2. Unless the AI is simply responding with something like “message received, thank you” I don’t think this is a good idea.

Yeah, we’re all stretched for time, I understand that. From the starting gun each morning we’re racing between patients, phone calls, incoming test results, staff questions, drug reps, sample closets, dictations, and a million other things.

But AI needs to be a lot better before I let it handle patient questions and concerns.

Someday, yeah, maybe it can do this, like 2-1B, the surgical droid that replaced Luke’s hand in “The Empire Strikes Back.” But we’re not even close to that. Just because a log-in screen says “Jumping to Hyperspace” doesn’t mean you’re on the Millennium Falcon.

Dr. Allan M. Block, a neurologist in Scottsdale, Arizona.
Dr. Allan M. Block


I generally know my patients, but even if I don’t remember them, I can quickly look up their charts and decide how to answer. AI can look up charts, too, but data is only a part of medicine.

There are a lot of things that don’t make it into a chart: our impressions of people and a knowledge of their personalities and anxieties. We take these into account when responding to their questions. People are different in how things need to be said to them, even if the answer is, overall, the same.

“It’s the AI’s fault” isn’t going to stand up in court, either.

I also have to question the benefit of the findings. If it lessens the “click burden” but still takes the same amount of time, are we really gaining anything?

I’m all for the digital age. In many ways it’s made my practice a lot easier. But I think it has a way to go before I let it start dealing directly with patients.

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

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Alzheimer’s Prevalence Predicted to Double by 2050

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An estimated 6.9 million older adults are living with Alzheimer’s disease (AD) in the United States, and another 200,000 people under age 65 have younger-onset AD, new data showed.

Findings from the annual report from the Alzheimer’s Association showed little change in AD prevalence since 2023, but study authors predicted the number of people over 65 with AD will nearly double by 2050.

The report also included sobering statistics on AD-related mortality — which increased 141% between 2001 and 2021 — and described “dementia neurology deserts” that will leave some states with less than 10 neurologists per 10,000 people with dementia as early as 2025. The shortages extend to other specialties, clinical professionals, and direct care workers, the report authors wrote.

“Dementia healthcare is a complex maze composed of primary care providers, specialists, social services, medication management, and caregiver support,” Sam Fazio, PhD, senior director, psychosocial research and quality care, Alzheimer’s Association, said in a press release.

“As the number of individuals living with Alzheimer’s continues to grow, ensuring patients, their caregivers, and families have a clear understanding of how to navigate dementia care resources is critical to improving health outcomes,” Dr. Fazio added.

The “2024 Alzheimer’s Disease Facts and Figures” study and accompanying report “Mapping a Better Future for Dementia Care Navigation” were published online on March 20 by the Alzheimer’s Association and will appear in the May issue of Alzheimer’s & Dementia.
 

Significant Increase in Mortality

The number of people over 65 with AD rose slightly in 2024 to 6.9 million from 6.7 million in 2023. The number of younger-onset AD cases remained roughly the same.

States and counties in the eastern and southeastern United States have the highest percentage of people over 65 with AD, with the District of Columbia reporting 16.8% and New York, Florida, and Mississippi between 12.5% and 12.7%. Alaska has the lowest with 8.8%.

Based on an analysis of death certificate data, the number of deaths from AD increased 141% between 2000 and 2021, while deaths from heart disease — the number-one cause of death — decreased 2.1%. Among people aged 70, 61% of those with AD are expected to die before age 80 compared with 30% of those without AD.

The cost of health and long-term care for people with AD has also risen, the data suggested, with a projected total for 2024 of $360 billion, a $15 billion increase since 2023. That figure does not include unpaid caregiving by family and friends, which the report valued at nearly $350 billion.

With the prevalence of AD expected to rise — the report projected 11.2 million by 2040 and 12.7 million by 2050 — mortality, morbidity, and healthcare costs will only continue to go up. Without new treatments and advancements in care, study authors estimated the cost will reach $1 trillion in 2050.

The report also waded into the issue of workforce deficits. Between 2012 and 2022, the number of direct care workers in the United States increased from 3.2 million to 4.8 million. Study authors estimated more than 1 million additional direct care workers will be needed before 2031.

There is a shortage of clinicians as well, especially for geriatricians, specially trained family physicians, or board-certified internists who can screen for, detect, and diagnose possible dementia. The National Center for Health Workforce Analysis (NCHWA) determined shortages in that specialty began a decade ago, and the projected need for geriatricians is expected to far exceed the supply in every region of the United States by 2050.

The NCHWA also projected a shortfall of neurologists by 2025. The report listed 20 US states as “dementia neurology deserts,” meaning they’re projected to have fewer than 10 neurologists per 10,000 people with dementia in 2025.

Several factors may contribute to the scarcity of specialists. In addition to an aging population, contributors include lower pay for geriatricians and neurologists compared with other specialists, an inadequate number of clinician educators with relevant specialties on faculties of health professional schools, and limited incentives to choose these specialties.
 

 

 

Underestimating a ‘Serious Problem’

The report “probably underestimates” the “serious problem with dementia specialty care in the United States,” David S. Knopman, MD, professor of neurology, Mayo Clinic, Rochester, Minnesota, told this news organization.

Given the complexity of managing treatments for AD, such as the monoclonal antibody lecanemab, or those for dementia with Lewy bodies, “my sense is that very few geriatricians are likely to take an active role in dementia care,” said Dr. Knopman.

Very few neurologists have specialty training in dementia diagnosis and care, he added, and neurologists who do specialize in dementia are generally located exclusively in tertiary medical centers.

“While neurologists are more likely to be able to diagnose dementia subtypes compared to geriatricians or general internists or family physicians, non-specialty neurologists are also unlikely to have the expertise to manage lecanemab therapy or to deal with diagnosis and management of dementia subtypes,” Dr. Knopman said.

“Filling the pipeline with new trainees is going to take a long, long time,” he added.

As it stands, most dementia diagnoses are not made by specialists. The report cited a study of Medicare beneficiaries that found 85% of people living with dementia were diagnosed by providers such as primary care physicians (PCPs).
 

Barriers to Care

Although screening is now a reimbursable service by Medicare, PCPs experience numerous barriers to detecting cognitive impairment and diagnosing dementia. Routinely used cognitive assessments are time-consuming and labor-intensive, making them challenging to use in a busy clinical setting.

“Even if dementia is diagnosed, providers sometimes wait to disclose this information to the patient due to diagnostic uncertainty, time constraints, stigma, and fear of causing emotional distress,” the authors wrote.

A previous survey by the Alzheimer’s Association uncovered a high degree of uncertainty and discomfort among PCPs in making a dementia diagnosis. While almost a third reported referring patients to specialists, 55% said there were not enough geriatricians and other specialists in their area to meet the demand.

In tackling the theme of dementia care navigation, the report included a survey of 1204 nonphysician healthcare workers, including nurses, physician assistants, and social workers.

About 60% believed the US healthcare system isn’t effectively helping patients and families navigate the system and that training in dementia care navigation is lacking and not standardized. Respondents also said nonmedical professionals are best suited to help people with dementia and their caregivers navigate care.

Respondents identified a range of barriers that make navigating dementia care difficult for patients and families. More than three in four (77%) identified a lack of community-based resources as a barrier. And 70% called out restrictions in current payment models as a barrier, with 41% saying this was the greatest barrier.
 

Alternative Model

In July, the Centers for Medicare & Medicaid Services will launch a pilot model in dementia care management, the Guiding an Improved Dementia Experience. The program will test a monthly per-patient payment model as a fee-for-service replacement.

Healthcare providers who participate in the program will deliver supportive services to people living with dementia and provide access to a care navigator to help patients and caregivers access services and support.

“There is growing momentum in this country to enhance dementia care navigation,” Dr. Fazio said in the release. “Dementia care navigation programs have shown they can be a huge benefit to people living with dementia and their caregivers.”

These programs are unfortunately not widespread across the country, but the Alzheimer’s Association hopes this report “will be a catalyst for change,” Dr. Fazio added.

A separate survey of dementia caregivers found they would overwhelmingly welcome navigator support. The vast majority (97%) said they would find navigation services helpful.

Such services may also go a long way to alleviating stresses involved in dementia caregiving, a top stressor being care coordination, the report noted. Seven in 10 caregiver survey respondents (70%) reported coordinating care is stressful. More than half (53%) said navigating healthcare is difficult, and two-thirds (66%) said they have difficulty finding resources and supports.

Around-the-clock support in addition to care coordination and help understanding their care recipient’s condition are among the top services dementia caregiver respondents cited as being most helpful.

Dr. Knopman reported no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

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An estimated 6.9 million older adults are living with Alzheimer’s disease (AD) in the United States, and another 200,000 people under age 65 have younger-onset AD, new data showed.

Findings from the annual report from the Alzheimer’s Association showed little change in AD prevalence since 2023, but study authors predicted the number of people over 65 with AD will nearly double by 2050.

The report also included sobering statistics on AD-related mortality — which increased 141% between 2001 and 2021 — and described “dementia neurology deserts” that will leave some states with less than 10 neurologists per 10,000 people with dementia as early as 2025. The shortages extend to other specialties, clinical professionals, and direct care workers, the report authors wrote.

“Dementia healthcare is a complex maze composed of primary care providers, specialists, social services, medication management, and caregiver support,” Sam Fazio, PhD, senior director, psychosocial research and quality care, Alzheimer’s Association, said in a press release.

“As the number of individuals living with Alzheimer’s continues to grow, ensuring patients, their caregivers, and families have a clear understanding of how to navigate dementia care resources is critical to improving health outcomes,” Dr. Fazio added.

The “2024 Alzheimer’s Disease Facts and Figures” study and accompanying report “Mapping a Better Future for Dementia Care Navigation” were published online on March 20 by the Alzheimer’s Association and will appear in the May issue of Alzheimer’s & Dementia.
 

Significant Increase in Mortality

The number of people over 65 with AD rose slightly in 2024 to 6.9 million from 6.7 million in 2023. The number of younger-onset AD cases remained roughly the same.

States and counties in the eastern and southeastern United States have the highest percentage of people over 65 with AD, with the District of Columbia reporting 16.8% and New York, Florida, and Mississippi between 12.5% and 12.7%. Alaska has the lowest with 8.8%.

Based on an analysis of death certificate data, the number of deaths from AD increased 141% between 2000 and 2021, while deaths from heart disease — the number-one cause of death — decreased 2.1%. Among people aged 70, 61% of those with AD are expected to die before age 80 compared with 30% of those without AD.

The cost of health and long-term care for people with AD has also risen, the data suggested, with a projected total for 2024 of $360 billion, a $15 billion increase since 2023. That figure does not include unpaid caregiving by family and friends, which the report valued at nearly $350 billion.

With the prevalence of AD expected to rise — the report projected 11.2 million by 2040 and 12.7 million by 2050 — mortality, morbidity, and healthcare costs will only continue to go up. Without new treatments and advancements in care, study authors estimated the cost will reach $1 trillion in 2050.

The report also waded into the issue of workforce deficits. Between 2012 and 2022, the number of direct care workers in the United States increased from 3.2 million to 4.8 million. Study authors estimated more than 1 million additional direct care workers will be needed before 2031.

There is a shortage of clinicians as well, especially for geriatricians, specially trained family physicians, or board-certified internists who can screen for, detect, and diagnose possible dementia. The National Center for Health Workforce Analysis (NCHWA) determined shortages in that specialty began a decade ago, and the projected need for geriatricians is expected to far exceed the supply in every region of the United States by 2050.

The NCHWA also projected a shortfall of neurologists by 2025. The report listed 20 US states as “dementia neurology deserts,” meaning they’re projected to have fewer than 10 neurologists per 10,000 people with dementia in 2025.

Several factors may contribute to the scarcity of specialists. In addition to an aging population, contributors include lower pay for geriatricians and neurologists compared with other specialists, an inadequate number of clinician educators with relevant specialties on faculties of health professional schools, and limited incentives to choose these specialties.
 

 

 

Underestimating a ‘Serious Problem’

The report “probably underestimates” the “serious problem with dementia specialty care in the United States,” David S. Knopman, MD, professor of neurology, Mayo Clinic, Rochester, Minnesota, told this news organization.

Given the complexity of managing treatments for AD, such as the monoclonal antibody lecanemab, or those for dementia with Lewy bodies, “my sense is that very few geriatricians are likely to take an active role in dementia care,” said Dr. Knopman.

Very few neurologists have specialty training in dementia diagnosis and care, he added, and neurologists who do specialize in dementia are generally located exclusively in tertiary medical centers.

“While neurologists are more likely to be able to diagnose dementia subtypes compared to geriatricians or general internists or family physicians, non-specialty neurologists are also unlikely to have the expertise to manage lecanemab therapy or to deal with diagnosis and management of dementia subtypes,” Dr. Knopman said.

“Filling the pipeline with new trainees is going to take a long, long time,” he added.

As it stands, most dementia diagnoses are not made by specialists. The report cited a study of Medicare beneficiaries that found 85% of people living with dementia were diagnosed by providers such as primary care physicians (PCPs).
 

Barriers to Care

Although screening is now a reimbursable service by Medicare, PCPs experience numerous barriers to detecting cognitive impairment and diagnosing dementia. Routinely used cognitive assessments are time-consuming and labor-intensive, making them challenging to use in a busy clinical setting.

“Even if dementia is diagnosed, providers sometimes wait to disclose this information to the patient due to diagnostic uncertainty, time constraints, stigma, and fear of causing emotional distress,” the authors wrote.

A previous survey by the Alzheimer’s Association uncovered a high degree of uncertainty and discomfort among PCPs in making a dementia diagnosis. While almost a third reported referring patients to specialists, 55% said there were not enough geriatricians and other specialists in their area to meet the demand.

In tackling the theme of dementia care navigation, the report included a survey of 1204 nonphysician healthcare workers, including nurses, physician assistants, and social workers.

About 60% believed the US healthcare system isn’t effectively helping patients and families navigate the system and that training in dementia care navigation is lacking and not standardized. Respondents also said nonmedical professionals are best suited to help people with dementia and their caregivers navigate care.

Respondents identified a range of barriers that make navigating dementia care difficult for patients and families. More than three in four (77%) identified a lack of community-based resources as a barrier. And 70% called out restrictions in current payment models as a barrier, with 41% saying this was the greatest barrier.
 

Alternative Model

In July, the Centers for Medicare & Medicaid Services will launch a pilot model in dementia care management, the Guiding an Improved Dementia Experience. The program will test a monthly per-patient payment model as a fee-for-service replacement.

Healthcare providers who participate in the program will deliver supportive services to people living with dementia and provide access to a care navigator to help patients and caregivers access services and support.

“There is growing momentum in this country to enhance dementia care navigation,” Dr. Fazio said in the release. “Dementia care navigation programs have shown they can be a huge benefit to people living with dementia and their caregivers.”

These programs are unfortunately not widespread across the country, but the Alzheimer’s Association hopes this report “will be a catalyst for change,” Dr. Fazio added.

A separate survey of dementia caregivers found they would overwhelmingly welcome navigator support. The vast majority (97%) said they would find navigation services helpful.

Such services may also go a long way to alleviating stresses involved in dementia caregiving, a top stressor being care coordination, the report noted. Seven in 10 caregiver survey respondents (70%) reported coordinating care is stressful. More than half (53%) said navigating healthcare is difficult, and two-thirds (66%) said they have difficulty finding resources and supports.

Around-the-clock support in addition to care coordination and help understanding their care recipient’s condition are among the top services dementia caregiver respondents cited as being most helpful.

Dr. Knopman reported no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

An estimated 6.9 million older adults are living with Alzheimer’s disease (AD) in the United States, and another 200,000 people under age 65 have younger-onset AD, new data showed.

Findings from the annual report from the Alzheimer’s Association showed little change in AD prevalence since 2023, but study authors predicted the number of people over 65 with AD will nearly double by 2050.

The report also included sobering statistics on AD-related mortality — which increased 141% between 2001 and 2021 — and described “dementia neurology deserts” that will leave some states with less than 10 neurologists per 10,000 people with dementia as early as 2025. The shortages extend to other specialties, clinical professionals, and direct care workers, the report authors wrote.

“Dementia healthcare is a complex maze composed of primary care providers, specialists, social services, medication management, and caregiver support,” Sam Fazio, PhD, senior director, psychosocial research and quality care, Alzheimer’s Association, said in a press release.

“As the number of individuals living with Alzheimer’s continues to grow, ensuring patients, their caregivers, and families have a clear understanding of how to navigate dementia care resources is critical to improving health outcomes,” Dr. Fazio added.

The “2024 Alzheimer’s Disease Facts and Figures” study and accompanying report “Mapping a Better Future for Dementia Care Navigation” were published online on March 20 by the Alzheimer’s Association and will appear in the May issue of Alzheimer’s & Dementia.
 

Significant Increase in Mortality

The number of people over 65 with AD rose slightly in 2024 to 6.9 million from 6.7 million in 2023. The number of younger-onset AD cases remained roughly the same.

States and counties in the eastern and southeastern United States have the highest percentage of people over 65 with AD, with the District of Columbia reporting 16.8% and New York, Florida, and Mississippi between 12.5% and 12.7%. Alaska has the lowest with 8.8%.

Based on an analysis of death certificate data, the number of deaths from AD increased 141% between 2000 and 2021, while deaths from heart disease — the number-one cause of death — decreased 2.1%. Among people aged 70, 61% of those with AD are expected to die before age 80 compared with 30% of those without AD.

The cost of health and long-term care for people with AD has also risen, the data suggested, with a projected total for 2024 of $360 billion, a $15 billion increase since 2023. That figure does not include unpaid caregiving by family and friends, which the report valued at nearly $350 billion.

With the prevalence of AD expected to rise — the report projected 11.2 million by 2040 and 12.7 million by 2050 — mortality, morbidity, and healthcare costs will only continue to go up. Without new treatments and advancements in care, study authors estimated the cost will reach $1 trillion in 2050.

The report also waded into the issue of workforce deficits. Between 2012 and 2022, the number of direct care workers in the United States increased from 3.2 million to 4.8 million. Study authors estimated more than 1 million additional direct care workers will be needed before 2031.

There is a shortage of clinicians as well, especially for geriatricians, specially trained family physicians, or board-certified internists who can screen for, detect, and diagnose possible dementia. The National Center for Health Workforce Analysis (NCHWA) determined shortages in that specialty began a decade ago, and the projected need for geriatricians is expected to far exceed the supply in every region of the United States by 2050.

The NCHWA also projected a shortfall of neurologists by 2025. The report listed 20 US states as “dementia neurology deserts,” meaning they’re projected to have fewer than 10 neurologists per 10,000 people with dementia in 2025.

Several factors may contribute to the scarcity of specialists. In addition to an aging population, contributors include lower pay for geriatricians and neurologists compared with other specialists, an inadequate number of clinician educators with relevant specialties on faculties of health professional schools, and limited incentives to choose these specialties.
 

 

 

Underestimating a ‘Serious Problem’

The report “probably underestimates” the “serious problem with dementia specialty care in the United States,” David S. Knopman, MD, professor of neurology, Mayo Clinic, Rochester, Minnesota, told this news organization.

Given the complexity of managing treatments for AD, such as the monoclonal antibody lecanemab, or those for dementia with Lewy bodies, “my sense is that very few geriatricians are likely to take an active role in dementia care,” said Dr. Knopman.

Very few neurologists have specialty training in dementia diagnosis and care, he added, and neurologists who do specialize in dementia are generally located exclusively in tertiary medical centers.

“While neurologists are more likely to be able to diagnose dementia subtypes compared to geriatricians or general internists or family physicians, non-specialty neurologists are also unlikely to have the expertise to manage lecanemab therapy or to deal with diagnosis and management of dementia subtypes,” Dr. Knopman said.

“Filling the pipeline with new trainees is going to take a long, long time,” he added.

As it stands, most dementia diagnoses are not made by specialists. The report cited a study of Medicare beneficiaries that found 85% of people living with dementia were diagnosed by providers such as primary care physicians (PCPs).
 

Barriers to Care

Although screening is now a reimbursable service by Medicare, PCPs experience numerous barriers to detecting cognitive impairment and diagnosing dementia. Routinely used cognitive assessments are time-consuming and labor-intensive, making them challenging to use in a busy clinical setting.

“Even if dementia is diagnosed, providers sometimes wait to disclose this information to the patient due to diagnostic uncertainty, time constraints, stigma, and fear of causing emotional distress,” the authors wrote.

A previous survey by the Alzheimer’s Association uncovered a high degree of uncertainty and discomfort among PCPs in making a dementia diagnosis. While almost a third reported referring patients to specialists, 55% said there were not enough geriatricians and other specialists in their area to meet the demand.

In tackling the theme of dementia care navigation, the report included a survey of 1204 nonphysician healthcare workers, including nurses, physician assistants, and social workers.

About 60% believed the US healthcare system isn’t effectively helping patients and families navigate the system and that training in dementia care navigation is lacking and not standardized. Respondents also said nonmedical professionals are best suited to help people with dementia and their caregivers navigate care.

Respondents identified a range of barriers that make navigating dementia care difficult for patients and families. More than three in four (77%) identified a lack of community-based resources as a barrier. And 70% called out restrictions in current payment models as a barrier, with 41% saying this was the greatest barrier.
 

Alternative Model

In July, the Centers for Medicare & Medicaid Services will launch a pilot model in dementia care management, the Guiding an Improved Dementia Experience. The program will test a monthly per-patient payment model as a fee-for-service replacement.

Healthcare providers who participate in the program will deliver supportive services to people living with dementia and provide access to a care navigator to help patients and caregivers access services and support.

“There is growing momentum in this country to enhance dementia care navigation,” Dr. Fazio said in the release. “Dementia care navigation programs have shown they can be a huge benefit to people living with dementia and their caregivers.”

These programs are unfortunately not widespread across the country, but the Alzheimer’s Association hopes this report “will be a catalyst for change,” Dr. Fazio added.

A separate survey of dementia caregivers found they would overwhelmingly welcome navigator support. The vast majority (97%) said they would find navigation services helpful.

Such services may also go a long way to alleviating stresses involved in dementia caregiving, a top stressor being care coordination, the report noted. Seven in 10 caregiver survey respondents (70%) reported coordinating care is stressful. More than half (53%) said navigating healthcare is difficult, and two-thirds (66%) said they have difficulty finding resources and supports.

Around-the-clock support in addition to care coordination and help understanding their care recipient’s condition are among the top services dementia caregiver respondents cited as being most helpful.

Dr. Knopman reported no relevant conflicts of interest.
 

A version of this article appeared on Medscape.com.

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Skin Test Accurately Detects Parkinson’s, Other Neurodegenerative Disorders

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Wed, 03/27/2024 - 07:37

A simple skin biopsy test is able to detect an abnormal form of alpha-synuclein with high accuracy in individuals with neurodegenerative disorders such as Parkinson’s disease (PD).

Researchers are hopeful that the test — which identified phosphorylated alpha-synuclein (P-SYN) with 95.5% accuracy in the blinded, multicenter trial — will accelerate not just early identification of synucleinopathies but also drug development.

Synucleinopathies include PD, dementia with Lewy bodies (DLB), multiple system atrophy (MSA), and pure autonomic failure (PAF).

“Each year, there are nearly 200,000 people in the U.S. who face a diagnosis of Parkinson’s disease, dementia with Lewy bodies, and related disorders,” study investigator Christopher H. Gibbons, MD, professor of neurology at Harvard Medical School in Boston, said in a press release.

He explained that patients often experience delays in diagnosis or are misdiagnosed due to the complexity of synucleinopathies.

“With a simple, minimally invasive skin biopsy test, this blinded, multicenter study demonstrated how we can more objectively identify the underlying pathology of synucleinopathies and offer better diagnostic answers and care for patients.”

The findings were published online on March 20 in JAMA.
 

An Urgent Priority

Affecting an estimated 2.5 million people in the United States, synucleinopathies are progressive neurodegenerative diseases with varying prognoses, so identifying a reliable diagnostic biomarker is an “urgent unmet priority,” the researchers noted.

The disorders share some symptoms such as tremors and cognitive changes, and all are characterized by P-SYN, an abnormal protein found in the cutaneous nerve fibers.

The study included 428 adults aged 40-99 years (mean age, 70 years) recruited from 30 academic and community-based neurology practices across the United States, with 277 diagnosed with PD, DLB, MSA, or PAF. It also included a control group of 120 participants with no symptoms suggestive of synucleinopathy.

Investigators used the commercially available Syn-One Test, developed in 2019 by CND Life Sciences, to analyze levels of P-SYN via 3-mm punch skin biopsies from each participant.

The test detected P-SYN in 95.5% of study participants overall, including 89 of 96 (92.7%) with PD, 54 of 55 (98.2%) with MSA, 48 of 50 (96%) with DLB, 22 of 22 (100%) with PAF, and 4 of 120 (3.3%) of the controls with no synucleinopathy.

The investigators said it is possible that some of the controls who tested positive had a subclinical form of synucleinopathy, which would explain the false positives.

Study limitations include clinical consensus diagnostic criteria without video or autopsy confirmation, a lack of genetic testing on participants (some genetic forms of PD do not have alpha-synuclein deposition), and the fact that controls were younger than those in disease groups.

“Further research is needed in unselected clinical populations to externally validate the findings and fully characterize the potential role of skin biopsy detection of P-SYN in clinical care,” the authors wrote.

Syn-One is not approved by the US Food and Drug Administration as a diagnostic test for PD but is available as a pathologic assay that determines whether a tissue sample contains phosphorylated alpha-synuclein and can be billed through Medicare.

The study was funded by the National Institutes of Health. Dr. Gibbons reported having stock options in CND Life Sciences outside the submitted work. Other disclosures are noted in the original article.

A version of this article appeared on Medscape.com.

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A simple skin biopsy test is able to detect an abnormal form of alpha-synuclein with high accuracy in individuals with neurodegenerative disorders such as Parkinson’s disease (PD).

Researchers are hopeful that the test — which identified phosphorylated alpha-synuclein (P-SYN) with 95.5% accuracy in the blinded, multicenter trial — will accelerate not just early identification of synucleinopathies but also drug development.

Synucleinopathies include PD, dementia with Lewy bodies (DLB), multiple system atrophy (MSA), and pure autonomic failure (PAF).

“Each year, there are nearly 200,000 people in the U.S. who face a diagnosis of Parkinson’s disease, dementia with Lewy bodies, and related disorders,” study investigator Christopher H. Gibbons, MD, professor of neurology at Harvard Medical School in Boston, said in a press release.

He explained that patients often experience delays in diagnosis or are misdiagnosed due to the complexity of synucleinopathies.

“With a simple, minimally invasive skin biopsy test, this blinded, multicenter study demonstrated how we can more objectively identify the underlying pathology of synucleinopathies and offer better diagnostic answers and care for patients.”

The findings were published online on March 20 in JAMA.
 

An Urgent Priority

Affecting an estimated 2.5 million people in the United States, synucleinopathies are progressive neurodegenerative diseases with varying prognoses, so identifying a reliable diagnostic biomarker is an “urgent unmet priority,” the researchers noted.

The disorders share some symptoms such as tremors and cognitive changes, and all are characterized by P-SYN, an abnormal protein found in the cutaneous nerve fibers.

The study included 428 adults aged 40-99 years (mean age, 70 years) recruited from 30 academic and community-based neurology practices across the United States, with 277 diagnosed with PD, DLB, MSA, or PAF. It also included a control group of 120 participants with no symptoms suggestive of synucleinopathy.

Investigators used the commercially available Syn-One Test, developed in 2019 by CND Life Sciences, to analyze levels of P-SYN via 3-mm punch skin biopsies from each participant.

The test detected P-SYN in 95.5% of study participants overall, including 89 of 96 (92.7%) with PD, 54 of 55 (98.2%) with MSA, 48 of 50 (96%) with DLB, 22 of 22 (100%) with PAF, and 4 of 120 (3.3%) of the controls with no synucleinopathy.

The investigators said it is possible that some of the controls who tested positive had a subclinical form of synucleinopathy, which would explain the false positives.

Study limitations include clinical consensus diagnostic criteria without video or autopsy confirmation, a lack of genetic testing on participants (some genetic forms of PD do not have alpha-synuclein deposition), and the fact that controls were younger than those in disease groups.

“Further research is needed in unselected clinical populations to externally validate the findings and fully characterize the potential role of skin biopsy detection of P-SYN in clinical care,” the authors wrote.

Syn-One is not approved by the US Food and Drug Administration as a diagnostic test for PD but is available as a pathologic assay that determines whether a tissue sample contains phosphorylated alpha-synuclein and can be billed through Medicare.

The study was funded by the National Institutes of Health. Dr. Gibbons reported having stock options in CND Life Sciences outside the submitted work. Other disclosures are noted in the original article.

A version of this article appeared on Medscape.com.

A simple skin biopsy test is able to detect an abnormal form of alpha-synuclein with high accuracy in individuals with neurodegenerative disorders such as Parkinson’s disease (PD).

Researchers are hopeful that the test — which identified phosphorylated alpha-synuclein (P-SYN) with 95.5% accuracy in the blinded, multicenter trial — will accelerate not just early identification of synucleinopathies but also drug development.

Synucleinopathies include PD, dementia with Lewy bodies (DLB), multiple system atrophy (MSA), and pure autonomic failure (PAF).

“Each year, there are nearly 200,000 people in the U.S. who face a diagnosis of Parkinson’s disease, dementia with Lewy bodies, and related disorders,” study investigator Christopher H. Gibbons, MD, professor of neurology at Harvard Medical School in Boston, said in a press release.

He explained that patients often experience delays in diagnosis or are misdiagnosed due to the complexity of synucleinopathies.

“With a simple, minimally invasive skin biopsy test, this blinded, multicenter study demonstrated how we can more objectively identify the underlying pathology of synucleinopathies and offer better diagnostic answers and care for patients.”

The findings were published online on March 20 in JAMA.
 

An Urgent Priority

Affecting an estimated 2.5 million people in the United States, synucleinopathies are progressive neurodegenerative diseases with varying prognoses, so identifying a reliable diagnostic biomarker is an “urgent unmet priority,” the researchers noted.

The disorders share some symptoms such as tremors and cognitive changes, and all are characterized by P-SYN, an abnormal protein found in the cutaneous nerve fibers.

The study included 428 adults aged 40-99 years (mean age, 70 years) recruited from 30 academic and community-based neurology practices across the United States, with 277 diagnosed with PD, DLB, MSA, or PAF. It also included a control group of 120 participants with no symptoms suggestive of synucleinopathy.

Investigators used the commercially available Syn-One Test, developed in 2019 by CND Life Sciences, to analyze levels of P-SYN via 3-mm punch skin biopsies from each participant.

The test detected P-SYN in 95.5% of study participants overall, including 89 of 96 (92.7%) with PD, 54 of 55 (98.2%) with MSA, 48 of 50 (96%) with DLB, 22 of 22 (100%) with PAF, and 4 of 120 (3.3%) of the controls with no synucleinopathy.

The investigators said it is possible that some of the controls who tested positive had a subclinical form of synucleinopathy, which would explain the false positives.

Study limitations include clinical consensus diagnostic criteria without video or autopsy confirmation, a lack of genetic testing on participants (some genetic forms of PD do not have alpha-synuclein deposition), and the fact that controls were younger than those in disease groups.

“Further research is needed in unselected clinical populations to externally validate the findings and fully characterize the potential role of skin biopsy detection of P-SYN in clinical care,” the authors wrote.

Syn-One is not approved by the US Food and Drug Administration as a diagnostic test for PD but is available as a pathologic assay that determines whether a tissue sample contains phosphorylated alpha-synuclein and can be billed through Medicare.

The study was funded by the National Institutes of Health. Dr. Gibbons reported having stock options in CND Life Sciences outside the submitted work. Other disclosures are noted in the original article.

A version of this article appeared on Medscape.com.

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