Neurology

An adult brain contains about 86 billion neurons and even more supercomputing power to closely monitor the entire human brain.

All those neurons have trillions of synapses – or connection points – that make up the circuitry the brain uses to control everything we do from reasoning to breathing to walking. And scientists with the Human Brain Project are trying to build new computing tools that can zoom in on every one of these synapses, peer inside cells, and zoom out to focus on entire regions of the brain at once.

Imaging the human brain at the cellular level would require several petabytes of data, researchers from the Human Brain Project report in Science. If you have an old smartphone or tablet with 32GB of storage, you’d need more than 31,000 of them to get a single petabyte of storage.

Using an electron microscope to image the entire brain would require more than one exabyte of data, the scientists point out. That’s more than a million petabytes.

Giacomo Indiveri, PhD, professor of neuroinformatics at the University of Zurich, Switzerland, says we need to fundamentally change the way we build computers. Delivering the keynote address at the Human Brain Project Summit in October, he warned we will use 20% of all the world’s electricity on computing by the year 2025.

To meet the computing challenges posed by the quest to map every bit of the human brain, researchers are working to produce the first two exascale supercomputers within the next 5 years. When they’re done, these machines will provide brain scientists with supercomputers powerful enough to explore the human brain in all its complexities.

A version of this article first appeared on Medscape.com.

An adult brain contains about 86 billion neurons and even more supercomputing power to closely monitor the entire human brain.

All those neurons have trillions of synapses – or connection points – that make up the circuitry the brain uses to control everything we do from reasoning to breathing to walking. And scientists with the Human Brain Project are trying to build new computing tools that can zoom in on every one of these synapses, peer inside cells, and zoom out to focus on entire regions of the brain at once.

Imaging the human brain at the cellular level would require several petabytes of data, researchers from the Human Brain Project report in Science. If you have an old smartphone or tablet with 32GB of storage, you’d need more than 31,000 of them to get a single petabyte of storage.

Using an electron microscope to image the entire brain would require more than one exabyte of data, the scientists point out. That’s more than a million petabytes.

Giacomo Indiveri, PhD, professor of neuroinformatics at the University of Zurich, Switzerland, says we need to fundamentally change the way we build computers. Delivering the keynote address at the Human Brain Project Summit in October, he warned we will use 20% of all the world’s electricity on computing by the year 2025.

To meet the computing challenges posed by the quest to map every bit of the human brain, researchers are working to produce the first two exascale supercomputers within the next 5 years. When they’re done, these machines will provide brain scientists with supercomputers powerful enough to explore the human brain in all its complexities.

A version of this article first appeared on Medscape.com.

An adult brain contains about 86 billion neurons and even more supercomputing power to closely monitor the entire human brain.

All those neurons have trillions of synapses – or connection points – that make up the circuitry the brain uses to control everything we do from reasoning to breathing to walking. And scientists with the Human Brain Project are trying to build new computing tools that can zoom in on every one of these synapses, peer inside cells, and zoom out to focus on entire regions of the brain at once.

Imaging the human brain at the cellular level would require several petabytes of data, researchers from the Human Brain Project report in Science. If you have an old smartphone or tablet with 32GB of storage, you’d need more than 31,000 of them to get a single petabyte of storage.

Using an electron microscope to image the entire brain would require more than one exabyte of data, the scientists point out. That’s more than a million petabytes.

Giacomo Indiveri, PhD, professor of neuroinformatics at the University of Zurich, Switzerland, says we need to fundamentally change the way we build computers. Delivering the keynote address at the Human Brain Project Summit in October, he warned we will use 20% of all the world’s electricity on computing by the year 2025.

To meet the computing challenges posed by the quest to map every bit of the human brain, researchers are working to produce the first two exascale supercomputers within the next 5 years. When they’re done, these machines will provide brain scientists with supercomputers powerful enough to explore the human brain in all its complexities.

A version of this article first appeared on Medscape.com.

Epstein-Barr virus (EBV) is the likely cause of multiple sclerosis (MS), new research confirms. Investigators found the risk of MS increased 32-fold following EBV infection.

This study is the first to provide compelling evidence of a causal link between EBV and MS, principal investigator Alberto Ascherio, MD, DrPH, professor of epidemiology, Harvard T. H. Chan School of Public Health, and professor of medicine, Harvard Medical School, Boston, told this news organization.

The “prevailing” view has been that MS is “an autoimmune disease of unknown etiology,” said Dr. Ascherio. “Now we know MS is a complication of a viral infection.” With this knowledge, he added, “we can redirect research” to find antiviral drugs to treat the disease.

The study was published online Jan. 13 in Science.
 

Unique dataset

A chronic disease of the central nervous system, MS involves an inflammatory attack on the myelin sheath and the axons it insulates. The disease affects 2.8 million people worldwide.

EBV is a human herpesvirus that can cause infectious mononucleosis. After infection, it persists in latent form in B-lymphocytes.

EBV is common and infects about 95% of adults. Most individuals are already infected with the virus by age 18 or 20 years, making it difficult to study uninfected populations, said Dr. Ascherio.

However, access to a “huge” database of more than 10 million active-duty U.S. service personnel made this possible, he said.

Service members are screened for HIV at the start of their service care and biennially thereafter. The investigators used stored blood samples to determine the relation between EBV infection and MS over a 20-year period from 1993 to 2013.

Researchers examined 801 MS case patients and 1,566 matched controls without MS. Most individuals were under 20 at the time of their first blood collection. Symptom onset for those who developed MS was a median of 10 years after the first sample was obtained.

Only one of the 801 MS case patients had no serologic evidence of EBV. This individual may have been infected with the virus after the last blood collection, failed to seroconvert in response to infection, or was misdiagnosed, the investigators note.

The hazard ratio for MS between EBV seroconversion versus persistent EBV seronegative was 32.4 (95% CI, 4.3-245.3; P < .001).
 

An MS vaccine?

MS risk was not increased after infection with cytomegalovirus, a herpesvirus that is transmitted through saliva, as is EBV.

Researchers measured serum concentrations of neurofilament light chain (sNflL), a biomarker of neuroaxonal degeneration, in samples from EBV-negative individuals at baseline. There were no signs of neuroaxonal degeneration before EBV seroconversion in subjects who later developed MS.

This indicates that “EBV infection preceded not only symptom onset but also the time of the first detectable pathological mechanisms underlying MS,” the investigators note.

The very magnitude of increased MS risk of MS observed EBV almost completely rules out confounding by known risk factors. Smoking and vitamin D deficiency double the risk, and genetic predisposition and childhood obesity also only raise the risks of MS to a “moderate” degree, said Dr. Ascherio.

It’s not clear why only some people infected with EBV go on to develop MS, he said.

The idea that reverse causation – that immune dysregulation during the preclinical phase of MS increases susceptibility to EBV infection – is unlikely, the investigators note. For instance, EBV seroconversion occurs before elevation of sNfL levels, an early marker of preclinical MS.

Since most MS cases appear to be caused by EBV, a suitable vaccine might thwart the disease. “A vaccine could, in theory, prevent infection and prevent MS,” said Dr. Ascherio, adding that there’s ongoing work to develop such a vaccine.

Another approach is to target the virus driving MS disease progression. Developing appropriate antivirals might treat and even cure MS, said Dr. Ascherio.
 

‘Compelling data’

In an accompanying commentary, William H. Robinson, MD, PhD, professor, Division of Immunology and Rheumatology, department of medicine, Stanford (Calif.) University, and a colleague said the study findings “provide compelling data that implicate EBV as the trigger for the development of MS.”

The mechanism or mechanisms by which EBV leads to MS “remain elusive,” the commentary authors write.

“Possibilities include molecular mimicry, through which EBV viral protein sequences mimic human myelin proteins and other CNS proteins and thereby induce autoimmunity against myelin and CNS antigens,” they note.

As other factors, including genetic susceptibility, are important to MS, EBV infection is likely necessary but not sufficient to trigger MS, said the commentary. “Infection with EBV is the initial pathogenic step in MS, but additional fuses must be ignited for the full pathophysiology.”

The commentary authors query whether there may be “new opportunities” for therapy with vaccines or antivirals. “Now that the initial trigger for MS has been identified, perhaps MS could be eradicated.”

In a statement from the Science Media Center, an independent venture promoting views from the scientific community, two other experts offered their take on the study.

Paul Farrell, PhD, professor of tumor virology, Imperial College London, said the paper “provides very clear confirmation of a causal role for EBV in most cases of MS.”

While there’s evidence that a vaccine can prevent the EBV disease infectious mononucleosis, no vaccine candidate has yet prevented the virus from infecting and establishing long-term persistence in people, noted Dr. Farrell.

“So, at this stage it is not clear whether a vaccine of the types currently being developed would be able to prevent the long-term effects of EBV in MS,” he said.

Daniel Davis, PhD, professor of immunology, University of Manchester, United Kingdom, commented that the value of this new discovery is not an immediate medical cure or treatment but is “a major step forward” in understanding MS.

The study “sets up new research working out the precise details of how this virus can sometimes lead to an autoimmune disease,” said Dr. Davis. “There is no shortage of ideas in how this might happen in principle and hopefully the correct details will emerge soon.”

The study received funding from the National Institute of Neurological Disorders and Stroke, National Institutes of Health, National Multiple Sclerosis Society, the German Research Foundation, the National Institutes of Health, and the Howard Hughes Medical Institute. Dr. Ascherio reports no relevant financial relaitonships. Dr. Robinson is a coinventor on a patent application filed by Stanford University that includes antibodies to EBV. Dr. Farrell reports serving on an ad hoc review panel for GSK on EBV vaccines in 2019 as a one off. He has a current grant from MRC on EBV biology, including some EBV sequence variation, but the grant is not about MS. Dr. Davis reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Epstein-Barr virus (EBV) is the likely cause of multiple sclerosis (MS), new research confirms. Investigators found the risk of MS increased 32-fold following EBV infection.

This study is the first to provide compelling evidence of a causal link between EBV and MS, principal investigator Alberto Ascherio, MD, DrPH, professor of epidemiology, Harvard T. H. Chan School of Public Health, and professor of medicine, Harvard Medical School, Boston, told this news organization.

The “prevailing” view has been that MS is “an autoimmune disease of unknown etiology,” said Dr. Ascherio. “Now we know MS is a complication of a viral infection.” With this knowledge, he added, “we can redirect research” to find antiviral drugs to treat the disease.

The study was published online Jan. 13 in Science.
 

Unique dataset

A chronic disease of the central nervous system, MS involves an inflammatory attack on the myelin sheath and the axons it insulates. The disease affects 2.8 million people worldwide.

EBV is a human herpesvirus that can cause infectious mononucleosis. After infection, it persists in latent form in B-lymphocytes.

EBV is common and infects about 95% of adults. Most individuals are already infected with the virus by age 18 or 20 years, making it difficult to study uninfected populations, said Dr. Ascherio.

However, access to a “huge” database of more than 10 million active-duty U.S. service personnel made this possible, he said.

Service members are screened for HIV at the start of their service care and biennially thereafter. The investigators used stored blood samples to determine the relation between EBV infection and MS over a 20-year period from 1993 to 2013.

Researchers examined 801 MS case patients and 1,566 matched controls without MS. Most individuals were under 20 at the time of their first blood collection. Symptom onset for those who developed MS was a median of 10 years after the first sample was obtained.

Only one of the 801 MS case patients had no serologic evidence of EBV. This individual may have been infected with the virus after the last blood collection, failed to seroconvert in response to infection, or was misdiagnosed, the investigators note.

The hazard ratio for MS between EBV seroconversion versus persistent EBV seronegative was 32.4 (95% CI, 4.3-245.3; P < .001).
 

An MS vaccine?

MS risk was not increased after infection with cytomegalovirus, a herpesvirus that is transmitted through saliva, as is EBV.

Researchers measured serum concentrations of neurofilament light chain (sNflL), a biomarker of neuroaxonal degeneration, in samples from EBV-negative individuals at baseline. There were no signs of neuroaxonal degeneration before EBV seroconversion in subjects who later developed MS.

This indicates that “EBV infection preceded not only symptom onset but also the time of the first detectable pathological mechanisms underlying MS,” the investigators note.

The very magnitude of increased MS risk of MS observed EBV almost completely rules out confounding by known risk factors. Smoking and vitamin D deficiency double the risk, and genetic predisposition and childhood obesity also only raise the risks of MS to a “moderate” degree, said Dr. Ascherio.

It’s not clear why only some people infected with EBV go on to develop MS, he said.

The idea that reverse causation – that immune dysregulation during the preclinical phase of MS increases susceptibility to EBV infection – is unlikely, the investigators note. For instance, EBV seroconversion occurs before elevation of sNfL levels, an early marker of preclinical MS.

Since most MS cases appear to be caused by EBV, a suitable vaccine might thwart the disease. “A vaccine could, in theory, prevent infection and prevent MS,” said Dr. Ascherio, adding that there’s ongoing work to develop such a vaccine.

Another approach is to target the virus driving MS disease progression. Developing appropriate antivirals might treat and even cure MS, said Dr. Ascherio.
 

‘Compelling data’

In an accompanying commentary, William H. Robinson, MD, PhD, professor, Division of Immunology and Rheumatology, department of medicine, Stanford (Calif.) University, and a colleague said the study findings “provide compelling data that implicate EBV as the trigger for the development of MS.”

The mechanism or mechanisms by which EBV leads to MS “remain elusive,” the commentary authors write.

“Possibilities include molecular mimicry, through which EBV viral protein sequences mimic human myelin proteins and other CNS proteins and thereby induce autoimmunity against myelin and CNS antigens,” they note.

As other factors, including genetic susceptibility, are important to MS, EBV infection is likely necessary but not sufficient to trigger MS, said the commentary. “Infection with EBV is the initial pathogenic step in MS, but additional fuses must be ignited for the full pathophysiology.”

The commentary authors query whether there may be “new opportunities” for therapy with vaccines or antivirals. “Now that the initial trigger for MS has been identified, perhaps MS could be eradicated.”

In a statement from the Science Media Center, an independent venture promoting views from the scientific community, two other experts offered their take on the study.

Paul Farrell, PhD, professor of tumor virology, Imperial College London, said the paper “provides very clear confirmation of a causal role for EBV in most cases of MS.”

While there’s evidence that a vaccine can prevent the EBV disease infectious mononucleosis, no vaccine candidate has yet prevented the virus from infecting and establishing long-term persistence in people, noted Dr. Farrell.

“So, at this stage it is not clear whether a vaccine of the types currently being developed would be able to prevent the long-term effects of EBV in MS,” he said.

Daniel Davis, PhD, professor of immunology, University of Manchester, United Kingdom, commented that the value of this new discovery is not an immediate medical cure or treatment but is “a major step forward” in understanding MS.

The study “sets up new research working out the precise details of how this virus can sometimes lead to an autoimmune disease,” said Dr. Davis. “There is no shortage of ideas in how this might happen in principle and hopefully the correct details will emerge soon.”

The study received funding from the National Institute of Neurological Disorders and Stroke, National Institutes of Health, National Multiple Sclerosis Society, the German Research Foundation, the National Institutes of Health, and the Howard Hughes Medical Institute. Dr. Ascherio reports no relevant financial relaitonships. Dr. Robinson is a coinventor on a patent application filed by Stanford University that includes antibodies to EBV. Dr. Farrell reports serving on an ad hoc review panel for GSK on EBV vaccines in 2019 as a one off. He has a current grant from MRC on EBV biology, including some EBV sequence variation, but the grant is not about MS. Dr. Davis reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Epstein-Barr virus (EBV) is the likely cause of multiple sclerosis (MS), new research confirms. Investigators found the risk of MS increased 32-fold following EBV infection.

This study is the first to provide compelling evidence of a causal link between EBV and MS, principal investigator Alberto Ascherio, MD, DrPH, professor of epidemiology, Harvard T. H. Chan School of Public Health, and professor of medicine, Harvard Medical School, Boston, told this news organization.

The “prevailing” view has been that MS is “an autoimmune disease of unknown etiology,” said Dr. Ascherio. “Now we know MS is a complication of a viral infection.” With this knowledge, he added, “we can redirect research” to find antiviral drugs to treat the disease.

The study was published online Jan. 13 in Science.
 

Unique dataset

A chronic disease of the central nervous system, MS involves an inflammatory attack on the myelin sheath and the axons it insulates. The disease affects 2.8 million people worldwide.

EBV is a human herpesvirus that can cause infectious mononucleosis. After infection, it persists in latent form in B-lymphocytes.

EBV is common and infects about 95% of adults. Most individuals are already infected with the virus by age 18 or 20 years, making it difficult to study uninfected populations, said Dr. Ascherio.

However, access to a “huge” database of more than 10 million active-duty U.S. service personnel made this possible, he said.

Service members are screened for HIV at the start of their service care and biennially thereafter. The investigators used stored blood samples to determine the relation between EBV infection and MS over a 20-year period from 1993 to 2013.

Researchers examined 801 MS case patients and 1,566 matched controls without MS. Most individuals were under 20 at the time of their first blood collection. Symptom onset for those who developed MS was a median of 10 years after the first sample was obtained.

Only one of the 801 MS case patients had no serologic evidence of EBV. This individual may have been infected with the virus after the last blood collection, failed to seroconvert in response to infection, or was misdiagnosed, the investigators note.

The hazard ratio for MS between EBV seroconversion versus persistent EBV seronegative was 32.4 (95% CI, 4.3-245.3; P < .001).
 

An MS vaccine?

MS risk was not increased after infection with cytomegalovirus, a herpesvirus that is transmitted through saliva, as is EBV.

Researchers measured serum concentrations of neurofilament light chain (sNflL), a biomarker of neuroaxonal degeneration, in samples from EBV-negative individuals at baseline. There were no signs of neuroaxonal degeneration before EBV seroconversion in subjects who later developed MS.

This indicates that “EBV infection preceded not only symptom onset but also the time of the first detectable pathological mechanisms underlying MS,” the investigators note.

The very magnitude of increased MS risk of MS observed EBV almost completely rules out confounding by known risk factors. Smoking and vitamin D deficiency double the risk, and genetic predisposition and childhood obesity also only raise the risks of MS to a “moderate” degree, said Dr. Ascherio.

It’s not clear why only some people infected with EBV go on to develop MS, he said.

The idea that reverse causation – that immune dysregulation during the preclinical phase of MS increases susceptibility to EBV infection – is unlikely, the investigators note. For instance, EBV seroconversion occurs before elevation of sNfL levels, an early marker of preclinical MS.

Since most MS cases appear to be caused by EBV, a suitable vaccine might thwart the disease. “A vaccine could, in theory, prevent infection and prevent MS,” said Dr. Ascherio, adding that there’s ongoing work to develop such a vaccine.

Another approach is to target the virus driving MS disease progression. Developing appropriate antivirals might treat and even cure MS, said Dr. Ascherio.
 

‘Compelling data’

In an accompanying commentary, William H. Robinson, MD, PhD, professor, Division of Immunology and Rheumatology, department of medicine, Stanford (Calif.) University, and a colleague said the study findings “provide compelling data that implicate EBV as the trigger for the development of MS.”

The mechanism or mechanisms by which EBV leads to MS “remain elusive,” the commentary authors write.

“Possibilities include molecular mimicry, through which EBV viral protein sequences mimic human myelin proteins and other CNS proteins and thereby induce autoimmunity against myelin and CNS antigens,” they note.

As other factors, including genetic susceptibility, are important to MS, EBV infection is likely necessary but not sufficient to trigger MS, said the commentary. “Infection with EBV is the initial pathogenic step in MS, but additional fuses must be ignited for the full pathophysiology.”

The commentary authors query whether there may be “new opportunities” for therapy with vaccines or antivirals. “Now that the initial trigger for MS has been identified, perhaps MS could be eradicated.”

In a statement from the Science Media Center, an independent venture promoting views from the scientific community, two other experts offered their take on the study.

Paul Farrell, PhD, professor of tumor virology, Imperial College London, said the paper “provides very clear confirmation of a causal role for EBV in most cases of MS.”

While there’s evidence that a vaccine can prevent the EBV disease infectious mononucleosis, no vaccine candidate has yet prevented the virus from infecting and establishing long-term persistence in people, noted Dr. Farrell.

“So, at this stage it is not clear whether a vaccine of the types currently being developed would be able to prevent the long-term effects of EBV in MS,” he said.

Daniel Davis, PhD, professor of immunology, University of Manchester, United Kingdom, commented that the value of this new discovery is not an immediate medical cure or treatment but is “a major step forward” in understanding MS.

The study “sets up new research working out the precise details of how this virus can sometimes lead to an autoimmune disease,” said Dr. Davis. “There is no shortage of ideas in how this might happen in principle and hopefully the correct details will emerge soon.”

The study received funding from the National Institute of Neurological Disorders and Stroke, National Institutes of Health, National Multiple Sclerosis Society, the German Research Foundation, the National Institutes of Health, and the Howard Hughes Medical Institute. Dr. Ascherio reports no relevant financial relaitonships. Dr. Robinson is a coinventor on a patent application filed by Stanford University that includes antibodies to EBV. Dr. Farrell reports serving on an ad hoc review panel for GSK on EBV vaccines in 2019 as a one off. He has a current grant from MRC on EBV biology, including some EBV sequence variation, but the grant is not about MS. Dr. Davis reports no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Medicare intends to limit coverage of the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen) via a special program intended to help assess how well this exorbitantly expensive medication works, federal officials announced Jan. 11.

On Dec. 20, 2021, Biogen announced a plan to reduce the annual U.S. cost of the drug by 50% – from $56,000 to $28,200 – as Centers for Medicare & Medicaid Services officials were deciding on Medicare’s coverage policy for the medication.

In making its proposed coverage decision, the CMS announced it will pay for aducanumab, a monoclonal antibody, under its coverage-with-evidence-development (CED) mechanism. In making its decision, the CMS approached aducanumab as the first of a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease. Food and Drug Administration–approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, the CMS said. The agency will accept public comments on this decision for 30 days.  

In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”

As previously reported, the FDA approved aducanumab on June 7, 2021, via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.

Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.

 

‘Unusual but appropriate’ step

The Medicare decision marks something of a shift in the agency’s approach to paying for medications. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’ Coverage and Analysis Group, admitted that the agency had taken an “unusual but appropriate” step in trying to set a national policy regarding payment for a drug.

On the same call, Lee Fleisher, MD, CMS’ chief medical officer, addressed the challenges presented by aducanumab, given the serious need for treatments for Alzheimer’s disease. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families,” Dr. Fleisher said. “We do know based on some of the evidence that there may be potential promise with this treatment. That’s why it is critical for us to pursue additional scientific evidence.”

The coverage-with-evidence program will allow Medicare to aid in gathering data, while protecting patients, Dr. Fleisher noted.

“CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population,” Dr. Fleisher said.
 

Biogen disappointed

Cambridge, Mass.–based Biogen urged the CMS to reconsider its approach to payment for aducanumab. In a statement, the company said Medicare should cover “the class of amyloid-directed therapies with the populations studied in the respective clinical trials and guided by expert recommendations for appropriate use.

“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said in the release.

In the company’s view, the CED approach will “significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations.

“CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option,” Biogen said.

Drug makers had been worried about CMS opting for CED even before the draft decision was unveiled.
 

Others weigh in

BIO, the trade group for biotechnology companies, urged the CMS to provide access to aducanumab without excess restrictions.

There already are concerns among drug makers about CMS efforts “to impose new coverage barriers – and, in particular, coverage with evidence development,” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.

Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted. “We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-altering and lifesaving medications,” the BIO officials wrote.

However, the CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.

In a press release, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right call.

“This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class in late-stage development. If these trials show more clear and robust clinical efficacy, then it is possible the FDA will give these amyloid monoclonal antibodies full approval, and Medicare would be likely to provide full payment,” he added.

A version of this article first appeared on Medscape.com.

Medicare intends to limit coverage of the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen) via a special program intended to help assess how well this exorbitantly expensive medication works, federal officials announced Jan. 11.

On Dec. 20, 2021, Biogen announced a plan to reduce the annual U.S. cost of the drug by 50% – from $56,000 to $28,200 – as Centers for Medicare & Medicaid Services officials were deciding on Medicare’s coverage policy for the medication.

In making its proposed coverage decision, the CMS announced it will pay for aducanumab, a monoclonal antibody, under its coverage-with-evidence-development (CED) mechanism. In making its decision, the CMS approached aducanumab as the first of a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease. Food and Drug Administration–approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, the CMS said. The agency will accept public comments on this decision for 30 days.  

In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”

As previously reported, the FDA approved aducanumab on June 7, 2021, via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.

Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.

 

‘Unusual but appropriate’ step

The Medicare decision marks something of a shift in the agency’s approach to paying for medications. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’ Coverage and Analysis Group, admitted that the agency had taken an “unusual but appropriate” step in trying to set a national policy regarding payment for a drug.

On the same call, Lee Fleisher, MD, CMS’ chief medical officer, addressed the challenges presented by aducanumab, given the serious need for treatments for Alzheimer’s disease. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families,” Dr. Fleisher said. “We do know based on some of the evidence that there may be potential promise with this treatment. That’s why it is critical for us to pursue additional scientific evidence.”

The coverage-with-evidence program will allow Medicare to aid in gathering data, while protecting patients, Dr. Fleisher noted.

“CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population,” Dr. Fleisher said.
 

Biogen disappointed

Cambridge, Mass.–based Biogen urged the CMS to reconsider its approach to payment for aducanumab. In a statement, the company said Medicare should cover “the class of amyloid-directed therapies with the populations studied in the respective clinical trials and guided by expert recommendations for appropriate use.

“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said in the release.

In the company’s view, the CED approach will “significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations.

“CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option,” Biogen said.

Drug makers had been worried about CMS opting for CED even before the draft decision was unveiled.
 

Others weigh in

BIO, the trade group for biotechnology companies, urged the CMS to provide access to aducanumab without excess restrictions.

There already are concerns among drug makers about CMS efforts “to impose new coverage barriers – and, in particular, coverage with evidence development,” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.

Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted. “We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-altering and lifesaving medications,” the BIO officials wrote.

However, the CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.

In a press release, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right call.

“This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class in late-stage development. If these trials show more clear and robust clinical efficacy, then it is possible the FDA will give these amyloid monoclonal antibodies full approval, and Medicare would be likely to provide full payment,” he added.

A version of this article first appeared on Medscape.com.

Medicare intends to limit coverage of the controversial Alzheimer’s drug aducanumab (Aduhelm, Biogen) via a special program intended to help assess how well this exorbitantly expensive medication works, federal officials announced Jan. 11.

On Dec. 20, 2021, Biogen announced a plan to reduce the annual U.S. cost of the drug by 50% – from $56,000 to $28,200 – as Centers for Medicare & Medicaid Services officials were deciding on Medicare’s coverage policy for the medication.

In making its proposed coverage decision, the CMS announced it will pay for aducanumab, a monoclonal antibody, under its coverage-with-evidence-development (CED) mechanism. In making its decision, the CMS approached aducanumab as the first of a potential new class of monoclonal antibodies for the treatment of Alzheimer’s disease. Food and Drug Administration–approved drugs in this class would be covered for those with Medicare only if they are enrolled in qualifying clinical trials, the CMS said. The agency will accept public comments on this decision for 30 days.  

In a statement, CMS Administrator Chiquita Brooks-LaSure said the agency is “committed to providing the American public with a clear, trusted, evidence-based decision that is made only after a thorough analysis of public feedback on the benefits and risks of coverage for Medicare patients.”

As previously reported, the FDA approved aducanumab on June 7, 2021, via an accelerated approval process. The approval, which set off a firestorm of controversy that included resignations of three FDA Peripheral and Central Nervous System Drugs Advisory Committee panel members, was granted based on the medication’s ability to reduce beta-amyloid plaque.

Under the accelerated approval mechanism, Biogen still must deliver solid scientific proof that aducanumab has clinically significant disease-modifying effects. However, the final evidence won’t be in any time soon. In its approval letter, the FDA set a 2030 deadline for a final report on this research.

 

‘Unusual but appropriate’ step

The Medicare decision marks something of a shift in the agency’s approach to paying for medications. On a call with reporters, Tamara Syrek Jensen, JD, director of CMS’ Coverage and Analysis Group, admitted that the agency had taken an “unusual but appropriate” step in trying to set a national policy regarding payment for a drug.

On the same call, Lee Fleisher, MD, CMS’ chief medical officer, addressed the challenges presented by aducanumab, given the serious need for treatments for Alzheimer’s disease. “As a practicing physician, I cannot overemphasize the need to understand the risks and benefits of a given treatment in order to better inform patients and their families,” Dr. Fleisher said. “We do know based on some of the evidence that there may be potential promise with this treatment. That’s why it is critical for us to pursue additional scientific evidence.”

The coverage-with-evidence program will allow Medicare to aid in gathering data, while protecting patients, Dr. Fleisher noted.

“CMS is using its authority provided by Congress to determine if the drug is considered reasonable and necessary, meaning that the benefits of improvement of cognition outweigh the harms in the Medicare population,” Dr. Fleisher said.
 

Biogen disappointed

Cambridge, Mass.–based Biogen urged the CMS to reconsider its approach to payment for aducanumab. In a statement, the company said Medicare should cover “the class of amyloid-directed therapies with the populations studied in the respective clinical trials and guided by expert recommendations for appropriate use.

“We believe Alzheimer’s patients should have access consistent with other therapies with FDA accelerated approval,” Biogen said in the release.

In the company’s view, the CED approach will “significantly limit patient access to an FDA-approved treatment, especially for underserved patients as evidenced in other CED determinations.

“CEDs can take months to years to initiate, and hundreds of Alzheimer’s patients – the majority of whom are Medicare beneficiaries – are progressing each day from mild to moderate disease stages, where treatment may no longer be an option,” Biogen said.

Drug makers had been worried about CMS opting for CED even before the draft decision was unveiled.
 

Others weigh in

BIO, the trade group for biotechnology companies, urged the CMS to provide access to aducanumab without excess restrictions.

There already are concerns among drug makers about CMS efforts “to impose new coverage barriers – and, in particular, coverage with evidence development,” Crystal Kuntz, vice president of policy and research at BIO, and Andy Cosgrove, the organization’s senior director for policy and research, noted in a July 2021 comment about the aducanumab review.

Medicare should instead continue to provide access to medicines for indications that the FDA has approved, with additional flexibility for off-label indications of cancer drugs, they noted. “We believe this should continue to be the case, to ensure that vulnerable Medicare beneficiaries have necessary access to life-altering and lifesaving medications,” the BIO officials wrote.

However, the CMS also received many pleas from physicians asking the agency to limit use of aducanumab at least until there is evidence that it produces a significant clinical benefit.

In a press release, Howard Fillit, MD, cofounder and chief science officer of the Alzheimer’s Drug Discovery Foundation, applauded the decision, describing it as “the right call.

“This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety profile of this drug in real-world populations. This decision has implications for other drugs in this class in late-stage development. If these trials show more clear and robust clinical efficacy, then it is possible the FDA will give these amyloid monoclonal antibodies full approval, and Medicare would be likely to provide full payment,” he added.

A version of this article first appeared on Medscape.com.

A new, augmented autism-screening strategy boosted the number of boys diagnosed with the condition, especially Spanish speakers, a new study finds. The research was published in JAMA Pediatrics

The number of diagnoses in girls didn’t budge significantly, however, surprising researchers. Still, the findings suggest that “multistage screening and appropriate access to diagnostic services can really move the needle on the early detection of autism and reducing disparities in autism diagnosis and detection,” said lead author R. Christopher Sheldrick, PhD, a Boston University research associate professor of health law, policy, and management, in an interview.

While early intervention is considered crucial, U.S. research suggests that several groups of children – the poor, racial and ethnic minorities, and non-English speakers – are more likely to be diagnosed with autism spectrum disorder (ASD) later in life. “They have much lower access to appropriate services, both to get kids diagnosed and to get the kinds of interventions that can be helpful for families,” Dr. Sheldrick said. “Our study is about trying to close the gap around diagnosis, the first step.”

For the new study, the researchers implemented an intervention strategy in Massachusetts at three Early Intervention (EI) programs, which provide autism screening to children who are referred by pediatricians or parents. The researchers then tracked the programs, all in Boston, and nine comparison programs from the greater Boston area from 2012 to 2018.

Overall, 33,326 children were assessed, all aged 14-36 months. Those at the intervention programs were chosen because they had high levels of poverty. Children at those programs were more likely to be Black than those at the comparison programs (30.7% vs. 12.2%), to be Spanish speakers (28.9% vs. 12.5%), and to be in the lowest household income bracket (66.9% vs. 54.2%). In both groups, about 64% of the children were male.

The intervention strategy aimed to reduce the reliance on screening tests. Instead, the study authors write, “our protocol emphasizes ASD screening as a process that includes clinician and parent decision-making.”

As Dr. Sheldrick explained, parents and specialists observe children together “and then decide whether it’s worth taking the next step, which is a full diagnostic assessment with a licensed professional.” According to the study, either the parent(s) or the specialists could make the referral for a full, university-based assessment.

The goal was to help specialists use their professional judgment more, he said, and refer children who don’t show signs of ASD via a screening instrument but still spark concern, he said. “We’re really trying to create a system in which the screening tools support professional judgment, but don’t really replace it.”

After weighting, the researchers found that diagnoses of ASD were more common in the intervention sites vs. comparison sites (incidence rate ratio, 1.6; 95% confidence interval, 1.3-2.1, P < .001), accounting for an extra 8.1 diagnoses per 1,000 per quarter. Among Spanish-speaking families only, diagnoses grew even more in the intervention sites vs. comparison sites (IRR, 2.6; 95% CI, 1.6-4.3; P < .001), representing 15.4 additional diagnoses per 1,000 children per quarter.

There was also an increase in diagnoses among boys in the intervention sites vs. comparison sites (IRR, 1.8; 95% CI, 1.4-2.3; P < .001), accounting for 14.8 additional diagnoses per 1,000 children per quarter. However, there was no statistically significant increase in diagnosis among girls (IRR, 1.1; 95% CI, 0.6-1.7; P = .84).

The finding about girls surprised the researchers. “The program was highly effective for boys, but really didn’t have any effect for girls,” Dr. Sheldrick said. “Even though autism is considered to be more common in boys, there are questions about whether it’s underidentified in girls. These data would be consistent with that view. So there’s work to do to be able to recognize how a young girl with autism might present and how you might note that in a sensitive way and then respond appropriately.”

The overall message of the study is “that screening with appropriate supports can make a difference,” he said. However, he acknowledged that the extra cost of the program is unclear. “We did not systematically collect data on cost,” he said, noting that the funding for the study paid for both the intervention and the analysis.

For now, he said, researchers are following the children in the study to see if they were able to access treatment services. Some of the investigators are also taking part in a randomized study to evaluate an intervention in children with social communication disorders, he said.

In an accompanying commentary, three pediatric specialists noted that the study is the first to analyze ASD screening in EI. “This study supports the notion of ASD screening as an iterative, multistep process that optimally involves multiple community stakeholders with varying levels of developmental expertise who have done the work to build trust with families,” write pediatrician Kate E. Wallis, MD, MPH, of Children’s Hospital of Philadelphia, graduate student Monica M. Abdul-Chani, MA, of the University of Alabama at Birmingham, and pediatrician Katharine E. Zuckerman, MD, MPH, of Oregon Health & Science University, Portland.

In regard to disparities in diagnosis in Spanish-speaking families, the commentary authors write that “locating a greater proportion of the ASD identification process in EI, which families are already familiar with, has no to low cost for families, and is likely geographically closer for families, can reduce structural barriers to identification.”

They add that the emphasis within Latino families on the “building of warm and caring relationships with others based on mutual trust and respect” can allow EI specialists to “develop relationships with families who may be afraid or skeptical of sharing what could be considered personal details of their family life.”

The commentary authors also note that “it remains all too common for language delays to be attributed to child exposure to two languages, even though data do not support this attribution. Bilingual EI staff can help to demystify this perpetual myth and better estimate a child’s communication and social skills in both languages as they communicate and play.”

The study was funded by grants from the Health Resources Services Administration and the National Institute of Mental Health. Dr. Sheldrick is cocreator of the Parent’s Observations of Social Interaction (POSI), which is one of the two first-stage screeners used in this study. He conducts research related to this instrument but receives no royalties. He reports grants from the National Institutes of Health. Coauthor Alice S. Carter, PhD, is cocreator of the POSI but receives no royalties. She is also cocreator of the Brief Infant Toddler Social Emotional Assessment, which is one of the two first-stage screeners used in this study, and receives royalties on the sale of the instrument. She reports grants from the National Institutes of Health and the Health Resources and Services Administration. Study coauthor Thomas I. Mackie, PhD, MPH, reports grants from the National Institute of Mental Health. Study coauthor Noah Hoch reports grants from the Health Resources Services Administration and the National Institute of Mental Health. No other disclosures from study authors are reported. Dr. Zuckerman reported grants from the National Institutes of Health and National Institute of Mental Health and consulting fees from H2N related to autism. The other commentary authors report no disclosures.

A new, augmented autism-screening strategy boosted the number of boys diagnosed with the condition, especially Spanish speakers, a new study finds. The research was published in JAMA Pediatrics

The number of diagnoses in girls didn’t budge significantly, however, surprising researchers. Still, the findings suggest that “multistage screening and appropriate access to diagnostic services can really move the needle on the early detection of autism and reducing disparities in autism diagnosis and detection,” said lead author R. Christopher Sheldrick, PhD, a Boston University research associate professor of health law, policy, and management, in an interview.

While early intervention is considered crucial, U.S. research suggests that several groups of children – the poor, racial and ethnic minorities, and non-English speakers – are more likely to be diagnosed with autism spectrum disorder (ASD) later in life. “They have much lower access to appropriate services, both to get kids diagnosed and to get the kinds of interventions that can be helpful for families,” Dr. Sheldrick said. “Our study is about trying to close the gap around diagnosis, the first step.”

For the new study, the researchers implemented an intervention strategy in Massachusetts at three Early Intervention (EI) programs, which provide autism screening to children who are referred by pediatricians or parents. The researchers then tracked the programs, all in Boston, and nine comparison programs from the greater Boston area from 2012 to 2018.

Overall, 33,326 children were assessed, all aged 14-36 months. Those at the intervention programs were chosen because they had high levels of poverty. Children at those programs were more likely to be Black than those at the comparison programs (30.7% vs. 12.2%), to be Spanish speakers (28.9% vs. 12.5%), and to be in the lowest household income bracket (66.9% vs. 54.2%). In both groups, about 64% of the children were male.

The intervention strategy aimed to reduce the reliance on screening tests. Instead, the study authors write, “our protocol emphasizes ASD screening as a process that includes clinician and parent decision-making.”

As Dr. Sheldrick explained, parents and specialists observe children together “and then decide whether it’s worth taking the next step, which is a full diagnostic assessment with a licensed professional.” According to the study, either the parent(s) or the specialists could make the referral for a full, university-based assessment.

The goal was to help specialists use their professional judgment more, he said, and refer children who don’t show signs of ASD via a screening instrument but still spark concern, he said. “We’re really trying to create a system in which the screening tools support professional judgment, but don’t really replace it.”

After weighting, the researchers found that diagnoses of ASD were more common in the intervention sites vs. comparison sites (incidence rate ratio, 1.6; 95% confidence interval, 1.3-2.1, P < .001), accounting for an extra 8.1 diagnoses per 1,000 per quarter. Among Spanish-speaking families only, diagnoses grew even more in the intervention sites vs. comparison sites (IRR, 2.6; 95% CI, 1.6-4.3; P < .001), representing 15.4 additional diagnoses per 1,000 children per quarter.

There was also an increase in diagnoses among boys in the intervention sites vs. comparison sites (IRR, 1.8; 95% CI, 1.4-2.3; P < .001), accounting for 14.8 additional diagnoses per 1,000 children per quarter. However, there was no statistically significant increase in diagnosis among girls (IRR, 1.1; 95% CI, 0.6-1.7; P = .84).

The finding about girls surprised the researchers. “The program was highly effective for boys, but really didn’t have any effect for girls,” Dr. Sheldrick said. “Even though autism is considered to be more common in boys, there are questions about whether it’s underidentified in girls. These data would be consistent with that view. So there’s work to do to be able to recognize how a young girl with autism might present and how you might note that in a sensitive way and then respond appropriately.”

The overall message of the study is “that screening with appropriate supports can make a difference,” he said. However, he acknowledged that the extra cost of the program is unclear. “We did not systematically collect data on cost,” he said, noting that the funding for the study paid for both the intervention and the analysis.

For now, he said, researchers are following the children in the study to see if they were able to access treatment services. Some of the investigators are also taking part in a randomized study to evaluate an intervention in children with social communication disorders, he said.

In an accompanying commentary, three pediatric specialists noted that the study is the first to analyze ASD screening in EI. “This study supports the notion of ASD screening as an iterative, multistep process that optimally involves multiple community stakeholders with varying levels of developmental expertise who have done the work to build trust with families,” write pediatrician Kate E. Wallis, MD, MPH, of Children’s Hospital of Philadelphia, graduate student Monica M. Abdul-Chani, MA, of the University of Alabama at Birmingham, and pediatrician Katharine E. Zuckerman, MD, MPH, of Oregon Health & Science University, Portland.

In regard to disparities in diagnosis in Spanish-speaking families, the commentary authors write that “locating a greater proportion of the ASD identification process in EI, which families are already familiar with, has no to low cost for families, and is likely geographically closer for families, can reduce structural barriers to identification.”

They add that the emphasis within Latino families on the “building of warm and caring relationships with others based on mutual trust and respect” can allow EI specialists to “develop relationships with families who may be afraid or skeptical of sharing what could be considered personal details of their family life.”

The commentary authors also note that “it remains all too common for language delays to be attributed to child exposure to two languages, even though data do not support this attribution. Bilingual EI staff can help to demystify this perpetual myth and better estimate a child’s communication and social skills in both languages as they communicate and play.”

The study was funded by grants from the Health Resources Services Administration and the National Institute of Mental Health. Dr. Sheldrick is cocreator of the Parent’s Observations of Social Interaction (POSI), which is one of the two first-stage screeners used in this study. He conducts research related to this instrument but receives no royalties. He reports grants from the National Institutes of Health. Coauthor Alice S. Carter, PhD, is cocreator of the POSI but receives no royalties. She is also cocreator of the Brief Infant Toddler Social Emotional Assessment, which is one of the two first-stage screeners used in this study, and receives royalties on the sale of the instrument. She reports grants from the National Institutes of Health and the Health Resources and Services Administration. Study coauthor Thomas I. Mackie, PhD, MPH, reports grants from the National Institute of Mental Health. Study coauthor Noah Hoch reports grants from the Health Resources Services Administration and the National Institute of Mental Health. No other disclosures from study authors are reported. Dr. Zuckerman reported grants from the National Institutes of Health and National Institute of Mental Health and consulting fees from H2N related to autism. The other commentary authors report no disclosures.

A new, augmented autism-screening strategy boosted the number of boys diagnosed with the condition, especially Spanish speakers, a new study finds. The research was published in JAMA Pediatrics

The number of diagnoses in girls didn’t budge significantly, however, surprising researchers. Still, the findings suggest that “multistage screening and appropriate access to diagnostic services can really move the needle on the early detection of autism and reducing disparities in autism diagnosis and detection,” said lead author R. Christopher Sheldrick, PhD, a Boston University research associate professor of health law, policy, and management, in an interview.

While early intervention is considered crucial, U.S. research suggests that several groups of children – the poor, racial and ethnic minorities, and non-English speakers – are more likely to be diagnosed with autism spectrum disorder (ASD) later in life. “They have much lower access to appropriate services, both to get kids diagnosed and to get the kinds of interventions that can be helpful for families,” Dr. Sheldrick said. “Our study is about trying to close the gap around diagnosis, the first step.”

For the new study, the researchers implemented an intervention strategy in Massachusetts at three Early Intervention (EI) programs, which provide autism screening to children who are referred by pediatricians or parents. The researchers then tracked the programs, all in Boston, and nine comparison programs from the greater Boston area from 2012 to 2018.

Overall, 33,326 children were assessed, all aged 14-36 months. Those at the intervention programs were chosen because they had high levels of poverty. Children at those programs were more likely to be Black than those at the comparison programs (30.7% vs. 12.2%), to be Spanish speakers (28.9% vs. 12.5%), and to be in the lowest household income bracket (66.9% vs. 54.2%). In both groups, about 64% of the children were male.

The intervention strategy aimed to reduce the reliance on screening tests. Instead, the study authors write, “our protocol emphasizes ASD screening as a process that includes clinician and parent decision-making.”

As Dr. Sheldrick explained, parents and specialists observe children together “and then decide whether it’s worth taking the next step, which is a full diagnostic assessment with a licensed professional.” According to the study, either the parent(s) or the specialists could make the referral for a full, university-based assessment.

The goal was to help specialists use their professional judgment more, he said, and refer children who don’t show signs of ASD via a screening instrument but still spark concern, he said. “We’re really trying to create a system in which the screening tools support professional judgment, but don’t really replace it.”

After weighting, the researchers found that diagnoses of ASD were more common in the intervention sites vs. comparison sites (incidence rate ratio, 1.6; 95% confidence interval, 1.3-2.1, P < .001), accounting for an extra 8.1 diagnoses per 1,000 per quarter. Among Spanish-speaking families only, diagnoses grew even more in the intervention sites vs. comparison sites (IRR, 2.6; 95% CI, 1.6-4.3; P < .001), representing 15.4 additional diagnoses per 1,000 children per quarter.

There was also an increase in diagnoses among boys in the intervention sites vs. comparison sites (IRR, 1.8; 95% CI, 1.4-2.3; P < .001), accounting for 14.8 additional diagnoses per 1,000 children per quarter. However, there was no statistically significant increase in diagnosis among girls (IRR, 1.1; 95% CI, 0.6-1.7; P = .84).

The finding about girls surprised the researchers. “The program was highly effective for boys, but really didn’t have any effect for girls,” Dr. Sheldrick said. “Even though autism is considered to be more common in boys, there are questions about whether it’s underidentified in girls. These data would be consistent with that view. So there’s work to do to be able to recognize how a young girl with autism might present and how you might note that in a sensitive way and then respond appropriately.”

The overall message of the study is “that screening with appropriate supports can make a difference,” he said. However, he acknowledged that the extra cost of the program is unclear. “We did not systematically collect data on cost,” he said, noting that the funding for the study paid for both the intervention and the analysis.

For now, he said, researchers are following the children in the study to see if they were able to access treatment services. Some of the investigators are also taking part in a randomized study to evaluate an intervention in children with social communication disorders, he said.

In an accompanying commentary, three pediatric specialists noted that the study is the first to analyze ASD screening in EI. “This study supports the notion of ASD screening as an iterative, multistep process that optimally involves multiple community stakeholders with varying levels of developmental expertise who have done the work to build trust with families,” write pediatrician Kate E. Wallis, MD, MPH, of Children’s Hospital of Philadelphia, graduate student Monica M. Abdul-Chani, MA, of the University of Alabama at Birmingham, and pediatrician Katharine E. Zuckerman, MD, MPH, of Oregon Health & Science University, Portland.

In regard to disparities in diagnosis in Spanish-speaking families, the commentary authors write that “locating a greater proportion of the ASD identification process in EI, which families are already familiar with, has no to low cost for families, and is likely geographically closer for families, can reduce structural barriers to identification.”

They add that the emphasis within Latino families on the “building of warm and caring relationships with others based on mutual trust and respect” can allow EI specialists to “develop relationships with families who may be afraid or skeptical of sharing what could be considered personal details of their family life.”

The commentary authors also note that “it remains all too common for language delays to be attributed to child exposure to two languages, even though data do not support this attribution. Bilingual EI staff can help to demystify this perpetual myth and better estimate a child’s communication and social skills in both languages as they communicate and play.”

The study was funded by grants from the Health Resources Services Administration and the National Institute of Mental Health. Dr. Sheldrick is cocreator of the Parent’s Observations of Social Interaction (POSI), which is one of the two first-stage screeners used in this study. He conducts research related to this instrument but receives no royalties. He reports grants from the National Institutes of Health. Coauthor Alice S. Carter, PhD, is cocreator of the POSI but receives no royalties. She is also cocreator of the Brief Infant Toddler Social Emotional Assessment, which is one of the two first-stage screeners used in this study, and receives royalties on the sale of the instrument. She reports grants from the National Institutes of Health and the Health Resources and Services Administration. Study coauthor Thomas I. Mackie, PhD, MPH, reports grants from the National Institute of Mental Health. Study coauthor Noah Hoch reports grants from the Health Resources Services Administration and the National Institute of Mental Health. No other disclosures from study authors are reported. Dr. Zuckerman reported grants from the National Institutes of Health and National Institute of Mental Health and consulting fees from H2N related to autism. The other commentary authors report no disclosures.

The number of individuals older than 40 with dementia will nearly triple worldwide and double in the United States by 2050 unless steps are taken to address risk factors, new research suggests.

Results from a study of 195 countries and territories estimates that by 2050, 153 million people are expected to have dementia worldwide – up from 57 million in 2019. In the United States, the number is expected to increase 100%, from an estimated 5.3 million in 2019 to 10.5 million in 2050.

The increase is largely driven by population growth and population aging, but researchers noted that expanding access to education and addressing risk factors such as obesity, high blood sugar, and smoking could blunt the rise in cases.

The study predicts increases in dementia in every country included in the analysis. The sharpest rise is expected in north Africa and the Middle East (367%) and sub-Saharan Africa (357%). The smallest increases will be in high-income countries in Asia Pacific (53%) and western Europe (74%).

Although the United States had the 37th lowest percentage increase across all countries considered, “this expected increase is still large and requires attention from policy and decision-makers,” said coinvestigator Emma Nichols, MPH, a researcher with the Institute for Health Metrics and Evaluation at the University of Washington, Seattle.

The findings were published online Jan. 6, 2022, in The Lancet Public Health (doi: 10.1016/S2468-2667[21]00249-8).
 

Dementia prevalence

For the study, researchers used country-specific estimates of dementia prevalence from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 study to project dementia prevalence globally, by world region, and at the country level.

They also used information on projected trends in four important dementia risk factors (high body mass index, high fasting plasma glucose, smoking, and education) to estimate how changes in these risk factors might impact dementia prevalence between 2019 and 2050.

Despite large increases in the projected number of people living with dementia, age-standardized both-sex prevalence remained stable between 2019 and 2050, with a global percentage change of 0.1% (95% uncertainty interval, –7.5 to 10.8).

Dementia prevalence was higher in women than in men and increased with age, doubling about every 5 years until 85 years of age in both 2019 and 2050 (female-to-male ratio, 1.67; 95% UI, 1.52-1.85).

Projected increases in cases could largely be attributed to population growth and population aging, although their relative importance varied by world region. Population growth contributed most to the increases in sub-Saharan Africa and population aging contributed most to the increases in east Asia.

The countries with the highest expected percentage change in total number of dementia cases between 2019 and 2050 were: Qatar (1,926%), United Arab Emirates (1,795%), Bahrain (1,084%), Oman (943%), Saudi Arabia (898%), Kuwait (850%), Iraq (559%), Maldives (554%), Jordan (522%), and Equatorial Guinea (498%).

The countries with the lowest expected percentage change in total number of dementia cases between 2019 and 2050 were Japan (27%), Bulgaria (37%), Serbia (38%), Lithuania (44%), Greece (45%), Latvia (47%), Croatia (55%), Ukraine (55%), Italy (56%), and Finland (58%).
 

Modifiable risk factors

Researchers also calculated how changes in risk factors might affect dementia prevalence. They found that improvements in global education access would reduce dementia prevalence by an estimated 6.2 million cases worldwide by 2050. However, that decrease would be offset by expected increases in obesity, high blood sugar, and smoking, which investigators estimate will result in an additional 6.8 million dementia cases.

The projections are based on expected trends in population aging, population growth, and risk factor trajectories, but “projections could change if effective interventions for modifiable risk factors are developed and deployed,” Ms. Nichols said.

In 2020, the Lancet Commission on Dementia Prevention, Intervention, and Care issued an update of its 2017 report, identifying 12 modifiable risk factors that could delay or prevent 40% of dementia cases. The risk factors were low education, hypertension, hearing impairment, smoking, midlife obesity, depression, physical inactivity, diabetes, social isolation, excessive alcohol consumption, head injury, and air pollution.

“Countries, including the U.S., should look to develop effective interventions for modifiable risk factors, but also should invest in the resources needed to support those with dementia and their caregivers,” Ms. Nichols said. She added that additional support for research and resources to develop therapeutic interventions is also warranted.
 

Oversimplifying mechanisms?

In an accompanying commentary, Michaël Schwarzinger, MD, and Carole Dufouil, PhD, of Bordeaux (France) University Hospital, noted that the authors’ efforts to build on GBD 2019 oversimplify the underlying mechanisms that cause dementia. The authors “provide somehow apocalyptic projections that do not factor in advisable changes in lifestyle over the lifetime,” they wrote.

“There is a considerable and urgent need to reinforce a public health approach towards dementia to better inform the people and decision-makers about the appropriate means to delay or avoid these dire projections,” the editorialists added.

The study was funded by the Bill and Melinda Gates Foundation and Gates Ventures. Ms. Nichols and the editorialists disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The number of individuals older than 40 with dementia will nearly triple worldwide and double in the United States by 2050 unless steps are taken to address risk factors, new research suggests.

Results from a study of 195 countries and territories estimates that by 2050, 153 million people are expected to have dementia worldwide – up from 57 million in 2019. In the United States, the number is expected to increase 100%, from an estimated 5.3 million in 2019 to 10.5 million in 2050.

The increase is largely driven by population growth and population aging, but researchers noted that expanding access to education and addressing risk factors such as obesity, high blood sugar, and smoking could blunt the rise in cases.

The study predicts increases in dementia in every country included in the analysis. The sharpest rise is expected in north Africa and the Middle East (367%) and sub-Saharan Africa (357%). The smallest increases will be in high-income countries in Asia Pacific (53%) and western Europe (74%).

Although the United States had the 37th lowest percentage increase across all countries considered, “this expected increase is still large and requires attention from policy and decision-makers,” said coinvestigator Emma Nichols, MPH, a researcher with the Institute for Health Metrics and Evaluation at the University of Washington, Seattle.

The findings were published online Jan. 6, 2022, in The Lancet Public Health (doi: 10.1016/S2468-2667[21]00249-8).
 

Dementia prevalence

For the study, researchers used country-specific estimates of dementia prevalence from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 study to project dementia prevalence globally, by world region, and at the country level.

They also used information on projected trends in four important dementia risk factors (high body mass index, high fasting plasma glucose, smoking, and education) to estimate how changes in these risk factors might impact dementia prevalence between 2019 and 2050.

Despite large increases in the projected number of people living with dementia, age-standardized both-sex prevalence remained stable between 2019 and 2050, with a global percentage change of 0.1% (95% uncertainty interval, –7.5 to 10.8).

Dementia prevalence was higher in women than in men and increased with age, doubling about every 5 years until 85 years of age in both 2019 and 2050 (female-to-male ratio, 1.67; 95% UI, 1.52-1.85).

Projected increases in cases could largely be attributed to population growth and population aging, although their relative importance varied by world region. Population growth contributed most to the increases in sub-Saharan Africa and population aging contributed most to the increases in east Asia.

The countries with the highest expected percentage change in total number of dementia cases between 2019 and 2050 were: Qatar (1,926%), United Arab Emirates (1,795%), Bahrain (1,084%), Oman (943%), Saudi Arabia (898%), Kuwait (850%), Iraq (559%), Maldives (554%), Jordan (522%), and Equatorial Guinea (498%).

The countries with the lowest expected percentage change in total number of dementia cases between 2019 and 2050 were Japan (27%), Bulgaria (37%), Serbia (38%), Lithuania (44%), Greece (45%), Latvia (47%), Croatia (55%), Ukraine (55%), Italy (56%), and Finland (58%).
 

Modifiable risk factors

Researchers also calculated how changes in risk factors might affect dementia prevalence. They found that improvements in global education access would reduce dementia prevalence by an estimated 6.2 million cases worldwide by 2050. However, that decrease would be offset by expected increases in obesity, high blood sugar, and smoking, which investigators estimate will result in an additional 6.8 million dementia cases.

The projections are based on expected trends in population aging, population growth, and risk factor trajectories, but “projections could change if effective interventions for modifiable risk factors are developed and deployed,” Ms. Nichols said.

In 2020, the Lancet Commission on Dementia Prevention, Intervention, and Care issued an update of its 2017 report, identifying 12 modifiable risk factors that could delay or prevent 40% of dementia cases. The risk factors were low education, hypertension, hearing impairment, smoking, midlife obesity, depression, physical inactivity, diabetes, social isolation, excessive alcohol consumption, head injury, and air pollution.

“Countries, including the U.S., should look to develop effective interventions for modifiable risk factors, but also should invest in the resources needed to support those with dementia and their caregivers,” Ms. Nichols said. She added that additional support for research and resources to develop therapeutic interventions is also warranted.
 

Oversimplifying mechanisms?

In an accompanying commentary, Michaël Schwarzinger, MD, and Carole Dufouil, PhD, of Bordeaux (France) University Hospital, noted that the authors’ efforts to build on GBD 2019 oversimplify the underlying mechanisms that cause dementia. The authors “provide somehow apocalyptic projections that do not factor in advisable changes in lifestyle over the lifetime,” they wrote.

“There is a considerable and urgent need to reinforce a public health approach towards dementia to better inform the people and decision-makers about the appropriate means to delay or avoid these dire projections,” the editorialists added.

The study was funded by the Bill and Melinda Gates Foundation and Gates Ventures. Ms. Nichols and the editorialists disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The number of individuals older than 40 with dementia will nearly triple worldwide and double in the United States by 2050 unless steps are taken to address risk factors, new research suggests.

Results from a study of 195 countries and territories estimates that by 2050, 153 million people are expected to have dementia worldwide – up from 57 million in 2019. In the United States, the number is expected to increase 100%, from an estimated 5.3 million in 2019 to 10.5 million in 2050.

The increase is largely driven by population growth and population aging, but researchers noted that expanding access to education and addressing risk factors such as obesity, high blood sugar, and smoking could blunt the rise in cases.

The study predicts increases in dementia in every country included in the analysis. The sharpest rise is expected in north Africa and the Middle East (367%) and sub-Saharan Africa (357%). The smallest increases will be in high-income countries in Asia Pacific (53%) and western Europe (74%).

Although the United States had the 37th lowest percentage increase across all countries considered, “this expected increase is still large and requires attention from policy and decision-makers,” said coinvestigator Emma Nichols, MPH, a researcher with the Institute for Health Metrics and Evaluation at the University of Washington, Seattle.

The findings were published online Jan. 6, 2022, in The Lancet Public Health (doi: 10.1016/S2468-2667[21]00249-8).
 

Dementia prevalence

For the study, researchers used country-specific estimates of dementia prevalence from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019 study to project dementia prevalence globally, by world region, and at the country level.

They also used information on projected trends in four important dementia risk factors (high body mass index, high fasting plasma glucose, smoking, and education) to estimate how changes in these risk factors might impact dementia prevalence between 2019 and 2050.

Despite large increases in the projected number of people living with dementia, age-standardized both-sex prevalence remained stable between 2019 and 2050, with a global percentage change of 0.1% (95% uncertainty interval, –7.5 to 10.8).

Dementia prevalence was higher in women than in men and increased with age, doubling about every 5 years until 85 years of age in both 2019 and 2050 (female-to-male ratio, 1.67; 95% UI, 1.52-1.85).

Projected increases in cases could largely be attributed to population growth and population aging, although their relative importance varied by world region. Population growth contributed most to the increases in sub-Saharan Africa and population aging contributed most to the increases in east Asia.

The countries with the highest expected percentage change in total number of dementia cases between 2019 and 2050 were: Qatar (1,926%), United Arab Emirates (1,795%), Bahrain (1,084%), Oman (943%), Saudi Arabia (898%), Kuwait (850%), Iraq (559%), Maldives (554%), Jordan (522%), and Equatorial Guinea (498%).

The countries with the lowest expected percentage change in total number of dementia cases between 2019 and 2050 were Japan (27%), Bulgaria (37%), Serbia (38%), Lithuania (44%), Greece (45%), Latvia (47%), Croatia (55%), Ukraine (55%), Italy (56%), and Finland (58%).
 

Modifiable risk factors

Researchers also calculated how changes in risk factors might affect dementia prevalence. They found that improvements in global education access would reduce dementia prevalence by an estimated 6.2 million cases worldwide by 2050. However, that decrease would be offset by expected increases in obesity, high blood sugar, and smoking, which investigators estimate will result in an additional 6.8 million dementia cases.

The projections are based on expected trends in population aging, population growth, and risk factor trajectories, but “projections could change if effective interventions for modifiable risk factors are developed and deployed,” Ms. Nichols said.

In 2020, the Lancet Commission on Dementia Prevention, Intervention, and Care issued an update of its 2017 report, identifying 12 modifiable risk factors that could delay or prevent 40% of dementia cases. The risk factors were low education, hypertension, hearing impairment, smoking, midlife obesity, depression, physical inactivity, diabetes, social isolation, excessive alcohol consumption, head injury, and air pollution.

“Countries, including the U.S., should look to develop effective interventions for modifiable risk factors, but also should invest in the resources needed to support those with dementia and their caregivers,” Ms. Nichols said. She added that additional support for research and resources to develop therapeutic interventions is also warranted.
 

Oversimplifying mechanisms?

In an accompanying commentary, Michaël Schwarzinger, MD, and Carole Dufouil, PhD, of Bordeaux (France) University Hospital, noted that the authors’ efforts to build on GBD 2019 oversimplify the underlying mechanisms that cause dementia. The authors “provide somehow apocalyptic projections that do not factor in advisable changes in lifestyle over the lifetime,” they wrote.

“There is a considerable and urgent need to reinforce a public health approach towards dementia to better inform the people and decision-makers about the appropriate means to delay or avoid these dire projections,” the editorialists added.

The study was funded by the Bill and Melinda Gates Foundation and Gates Ventures. Ms. Nichols and the editorialists disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Inpatient and outpatient treatments of transient ischemic attack (TIA) or minor ischemic stroke (mIS) yield comparable safety outcomes, new research suggests. In a meta-analysis of more than 200,000 patients with TIA or mIS, risk for subsequent stroke within 90 days was 2.1% for those treated in a TIA clinic versus 2.8% for patients treated in inpatient settings, which was not significantly different. The risk for patients treated in an emergency department was higher, at 3.5%.

“The message is that if you do the correct risk stratification and then triage patients based on their risk profile, you can safely discharge and have a timely follow-up for the patients who have low risk for a subsequent event,” said coinvestigator Ramin Zand, MD, vascular neurologist and stroke attending physician at Geisinger Health System, Danville, Pennsylvania.

The findings were published online Jan. 5 in JAMA Network Open.
 

Higher risk in EDs

There is currently no consensus on the care protocol for patients with TIA or mIS, and the rate at which these patients are hospitalized varies by region, hospital, and practitioner, the investigators noted.

Previous studies have indicated that outpatient management of certain individuals with TIA can be safe and cost-effective.

The current researchers searched for retrospective and prospective studies of adult patients that provided information about ischemic stroke after TIA or mIS. Studies that used time- and tissue-based definitions of TIA were included, as well as studies that used various definitions of mIS.

The investigators examined care provided at TIA clinics, inpatient settings (such as medical-surgical units, stroke units, or observation units), EDs, and unspecified settings. Their main aim was to compare outcomes between TIA clinics and inpatient settings.

In all, 226,683 patients (recruited between 1981 and 2018) from 71 studies were included in the meta-analysis. The studies examined 101 cohorts, 24 of which were studied prospectively. Among the 5,636 patients who received care in TIA clinics, the mean age was 65.7 years, and 50.8% of this group were men. Among the 130,139 inpatients, the mean age was 78.3 years, and 61.6% of the group were women.

Results showed no significant difference in risk for subsequent stroke between patients treated in the inpatient and outpatient settings.

Among patients treated in a TIA clinic, risk for subsequent stroke following a TIA or mIS was 0.3% within 2 days, 1.0% within 7 days, 1.3% within 30 days, and 2.1% within 90 days. Among those treated as inpatients, risk for subsequent stroke was 0.5% within 2 days, 1.2% within 7 days, 1.6% within 30 days, and 2.8% within 90 days.

Risk for subsequent stroke was higher among patients treated in the ED and in unspecified settings. At the EDs, the risk was 1.9% within 2 days, 3.4% within 7 days, 3.5% within 30 days, and 3.5% within 90 days. Among those treated in unspecified settings, the risk was 2.2% within 2 days, 3.4% within 7 days, 4.2% within 30 days, and 6.0% within 90 days.

Patients treated in the ED also had a significantly higher risk for subsequent stroke at 2 and 7 days, compared with those treated in inpatient settings and a significantly higher risk for subsequent stroke at 2, 7, and 90 days, compared with those treated in TIA clinics.
 

‘Most comprehensive look’

“This is the most comprehensive look at all the studies to try and answer this research question,” said Dr. Zand. The results were similar to what was expected, he added.

The infrastructure and resources differed among the sites at which the various studies were conducted, and the investigators adjusted for these differences as much as possible, Dr. Zand noted. A certain amount of selection bias may remain, but it does not affect the overall conclusion, he added.

“Timely outpatient care among low-risk TIA patients is both feasible and safe,” he said.

Dr. Zand noted that the findings have implications not only for patient management but also for the management of the health system. “It’s not feasible nor desirable to admit all the TIA patients, especially with the lessons that we learned from COVID, the burden on the health systems, and the fact that many hospitals are operating at full capacity right now,” he said.

The recommendation is to hospitalize high-risk patients and provide outpatient evaluation and workup to low-risk patients, he added. “This is exactly what we saw in this study,” Dr. Zand said.
 

Selection bias?

Commenting on the research, Louis R. Caplan, MD, professor of neurology at Harvard Medical School, Boston, noted that evaluation of patients with TIA or mIS “can be done very well as an outpatient” if clinicians have experienced personnel, the outpatient facilities to do the studies necessary, and criteria in place for deciding who to admit or not admit.

However, the decision on whether to choose an inpatient or outpatient approach for a particular patient is complicated, said Dr. Caplan, who was not involved with the research.

Clinicians must consider factors such as whether the patient is mobile, has a car, or has a significant other. The patient’s symptoms and past illnesses also influence the decision, he added.

Dr. Caplan noted that in the meta-analysis, far fewer patients were seen in the TIA clinics than were seen in the inpatient setting. In addition, none of the studies used uniform criteria to determine which patients should undergo workup as outpatients and which as inpatients. “There was a lot of selection bias that may have had nothing to do with how sick the person was,” Dr. Caplan said.

In addition, few hospitals in the United States have an outpatient TIA clinic, he noted. Most of the studies of TIA clinics that the researchers examined were conducted in Europe. “It’s easier to do [that] in Europe because of their socialized medicine,” said Dr. Caplan.

But TIA clinics should be more widespread in the U.S., he added. “Insurance companies should be willing to pay for comparable facilities, inpatient and outpatient,” he said.

The study was conducted without external funding. Dr. Zand reported no relevant financial relationships. Dr. Caplan was an investigator for TIAregistry.org, which analyzed the outcomes of treatment in TIA clinics in Europe.

A version of this article first appeared on Medscape.com.

Inpatient and outpatient treatments of transient ischemic attack (TIA) or minor ischemic stroke (mIS) yield comparable safety outcomes, new research suggests. In a meta-analysis of more than 200,000 patients with TIA or mIS, risk for subsequent stroke within 90 days was 2.1% for those treated in a TIA clinic versus 2.8% for patients treated in inpatient settings, which was not significantly different. The risk for patients treated in an emergency department was higher, at 3.5%.

“The message is that if you do the correct risk stratification and then triage patients based on their risk profile, you can safely discharge and have a timely follow-up for the patients who have low risk for a subsequent event,” said coinvestigator Ramin Zand, MD, vascular neurologist and stroke attending physician at Geisinger Health System, Danville, Pennsylvania.

The findings were published online Jan. 5 in JAMA Network Open.
 

Higher risk in EDs

There is currently no consensus on the care protocol for patients with TIA or mIS, and the rate at which these patients are hospitalized varies by region, hospital, and practitioner, the investigators noted.

Previous studies have indicated that outpatient management of certain individuals with TIA can be safe and cost-effective.

The current researchers searched for retrospective and prospective studies of adult patients that provided information about ischemic stroke after TIA or mIS. Studies that used time- and tissue-based definitions of TIA were included, as well as studies that used various definitions of mIS.

The investigators examined care provided at TIA clinics, inpatient settings (such as medical-surgical units, stroke units, or observation units), EDs, and unspecified settings. Their main aim was to compare outcomes between TIA clinics and inpatient settings.

In all, 226,683 patients (recruited between 1981 and 2018) from 71 studies were included in the meta-analysis. The studies examined 101 cohorts, 24 of which were studied prospectively. Among the 5,636 patients who received care in TIA clinics, the mean age was 65.7 years, and 50.8% of this group were men. Among the 130,139 inpatients, the mean age was 78.3 years, and 61.6% of the group were women.

Results showed no significant difference in risk for subsequent stroke between patients treated in the inpatient and outpatient settings.

Among patients treated in a TIA clinic, risk for subsequent stroke following a TIA or mIS was 0.3% within 2 days, 1.0% within 7 days, 1.3% within 30 days, and 2.1% within 90 days. Among those treated as inpatients, risk for subsequent stroke was 0.5% within 2 days, 1.2% within 7 days, 1.6% within 30 days, and 2.8% within 90 days.

Risk for subsequent stroke was higher among patients treated in the ED and in unspecified settings. At the EDs, the risk was 1.9% within 2 days, 3.4% within 7 days, 3.5% within 30 days, and 3.5% within 90 days. Among those treated in unspecified settings, the risk was 2.2% within 2 days, 3.4% within 7 days, 4.2% within 30 days, and 6.0% within 90 days.

Patients treated in the ED also had a significantly higher risk for subsequent stroke at 2 and 7 days, compared with those treated in inpatient settings and a significantly higher risk for subsequent stroke at 2, 7, and 90 days, compared with those treated in TIA clinics.
 

‘Most comprehensive look’

“This is the most comprehensive look at all the studies to try and answer this research question,” said Dr. Zand. The results were similar to what was expected, he added.

The infrastructure and resources differed among the sites at which the various studies were conducted, and the investigators adjusted for these differences as much as possible, Dr. Zand noted. A certain amount of selection bias may remain, but it does not affect the overall conclusion, he added.

“Timely outpatient care among low-risk TIA patients is both feasible and safe,” he said.

Dr. Zand noted that the findings have implications not only for patient management but also for the management of the health system. “It’s not feasible nor desirable to admit all the TIA patients, especially with the lessons that we learned from COVID, the burden on the health systems, and the fact that many hospitals are operating at full capacity right now,” he said.

The recommendation is to hospitalize high-risk patients and provide outpatient evaluation and workup to low-risk patients, he added. “This is exactly what we saw in this study,” Dr. Zand said.
 

Selection bias?

Commenting on the research, Louis R. Caplan, MD, professor of neurology at Harvard Medical School, Boston, noted that evaluation of patients with TIA or mIS “can be done very well as an outpatient” if clinicians have experienced personnel, the outpatient facilities to do the studies necessary, and criteria in place for deciding who to admit or not admit.

However, the decision on whether to choose an inpatient or outpatient approach for a particular patient is complicated, said Dr. Caplan, who was not involved with the research.

Clinicians must consider factors such as whether the patient is mobile, has a car, or has a significant other. The patient’s symptoms and past illnesses also influence the decision, he added.

Dr. Caplan noted that in the meta-analysis, far fewer patients were seen in the TIA clinics than were seen in the inpatient setting. In addition, none of the studies used uniform criteria to determine which patients should undergo workup as outpatients and which as inpatients. “There was a lot of selection bias that may have had nothing to do with how sick the person was,” Dr. Caplan said.

In addition, few hospitals in the United States have an outpatient TIA clinic, he noted. Most of the studies of TIA clinics that the researchers examined were conducted in Europe. “It’s easier to do [that] in Europe because of their socialized medicine,” said Dr. Caplan.

But TIA clinics should be more widespread in the U.S., he added. “Insurance companies should be willing to pay for comparable facilities, inpatient and outpatient,” he said.

The study was conducted without external funding. Dr. Zand reported no relevant financial relationships. Dr. Caplan was an investigator for TIAregistry.org, which analyzed the outcomes of treatment in TIA clinics in Europe.

A version of this article first appeared on Medscape.com.

Inpatient and outpatient treatments of transient ischemic attack (TIA) or minor ischemic stroke (mIS) yield comparable safety outcomes, new research suggests. In a meta-analysis of more than 200,000 patients with TIA or mIS, risk for subsequent stroke within 90 days was 2.1% for those treated in a TIA clinic versus 2.8% for patients treated in inpatient settings, which was not significantly different. The risk for patients treated in an emergency department was higher, at 3.5%.

“The message is that if you do the correct risk stratification and then triage patients based on their risk profile, you can safely discharge and have a timely follow-up for the patients who have low risk for a subsequent event,” said coinvestigator Ramin Zand, MD, vascular neurologist and stroke attending physician at Geisinger Health System, Danville, Pennsylvania.

The findings were published online Jan. 5 in JAMA Network Open.
 

Higher risk in EDs

There is currently no consensus on the care protocol for patients with TIA or mIS, and the rate at which these patients are hospitalized varies by region, hospital, and practitioner, the investigators noted.

Previous studies have indicated that outpatient management of certain individuals with TIA can be safe and cost-effective.

The current researchers searched for retrospective and prospective studies of adult patients that provided information about ischemic stroke after TIA or mIS. Studies that used time- and tissue-based definitions of TIA were included, as well as studies that used various definitions of mIS.

The investigators examined care provided at TIA clinics, inpatient settings (such as medical-surgical units, stroke units, or observation units), EDs, and unspecified settings. Their main aim was to compare outcomes between TIA clinics and inpatient settings.

In all, 226,683 patients (recruited between 1981 and 2018) from 71 studies were included in the meta-analysis. The studies examined 101 cohorts, 24 of which were studied prospectively. Among the 5,636 patients who received care in TIA clinics, the mean age was 65.7 years, and 50.8% of this group were men. Among the 130,139 inpatients, the mean age was 78.3 years, and 61.6% of the group were women.

Results showed no significant difference in risk for subsequent stroke between patients treated in the inpatient and outpatient settings.

Among patients treated in a TIA clinic, risk for subsequent stroke following a TIA or mIS was 0.3% within 2 days, 1.0% within 7 days, 1.3% within 30 days, and 2.1% within 90 days. Among those treated as inpatients, risk for subsequent stroke was 0.5% within 2 days, 1.2% within 7 days, 1.6% within 30 days, and 2.8% within 90 days.

Risk for subsequent stroke was higher among patients treated in the ED and in unspecified settings. At the EDs, the risk was 1.9% within 2 days, 3.4% within 7 days, 3.5% within 30 days, and 3.5% within 90 days. Among those treated in unspecified settings, the risk was 2.2% within 2 days, 3.4% within 7 days, 4.2% within 30 days, and 6.0% within 90 days.

Patients treated in the ED also had a significantly higher risk for subsequent stroke at 2 and 7 days, compared with those treated in inpatient settings and a significantly higher risk for subsequent stroke at 2, 7, and 90 days, compared with those treated in TIA clinics.
 

‘Most comprehensive look’

“This is the most comprehensive look at all the studies to try and answer this research question,” said Dr. Zand. The results were similar to what was expected, he added.

The infrastructure and resources differed among the sites at which the various studies were conducted, and the investigators adjusted for these differences as much as possible, Dr. Zand noted. A certain amount of selection bias may remain, but it does not affect the overall conclusion, he added.

“Timely outpatient care among low-risk TIA patients is both feasible and safe,” he said.

Dr. Zand noted that the findings have implications not only for patient management but also for the management of the health system. “It’s not feasible nor desirable to admit all the TIA patients, especially with the lessons that we learned from COVID, the burden on the health systems, and the fact that many hospitals are operating at full capacity right now,” he said.

The recommendation is to hospitalize high-risk patients and provide outpatient evaluation and workup to low-risk patients, he added. “This is exactly what we saw in this study,” Dr. Zand said.
 

Selection bias?

Commenting on the research, Louis R. Caplan, MD, professor of neurology at Harvard Medical School, Boston, noted that evaluation of patients with TIA or mIS “can be done very well as an outpatient” if clinicians have experienced personnel, the outpatient facilities to do the studies necessary, and criteria in place for deciding who to admit or not admit.

However, the decision on whether to choose an inpatient or outpatient approach for a particular patient is complicated, said Dr. Caplan, who was not involved with the research.

Clinicians must consider factors such as whether the patient is mobile, has a car, or has a significant other. The patient’s symptoms and past illnesses also influence the decision, he added.

Dr. Caplan noted that in the meta-analysis, far fewer patients were seen in the TIA clinics than were seen in the inpatient setting. In addition, none of the studies used uniform criteria to determine which patients should undergo workup as outpatients and which as inpatients. “There was a lot of selection bias that may have had nothing to do with how sick the person was,” Dr. Caplan said.

In addition, few hospitals in the United States have an outpatient TIA clinic, he noted. Most of the studies of TIA clinics that the researchers examined were conducted in Europe. “It’s easier to do [that] in Europe because of their socialized medicine,” said Dr. Caplan.

But TIA clinics should be more widespread in the U.S., he added. “Insurance companies should be willing to pay for comparable facilities, inpatient and outpatient,” he said.

The study was conducted without external funding. Dr. Zand reported no relevant financial relationships. Dr. Caplan was an investigator for TIAregistry.org, which analyzed the outcomes of treatment in TIA clinics in Europe.

A version of this article first appeared on Medscape.com.

Alcohol is the most common substance misused by veterans. ¹ Veterans may m isuse alcohol as a result of mental illness or posttraumatic stress disorder (PTSD), having difficulties adjusting to civilian life, or because of heavy drinking habits acquired before leaving active duty. ² One potential long-term effect of chronic alcohol misuse is Wernicke-Korsakoff syndrome (WKS), a neuropsychiatric condition secondary to a deficiency of thiamine. ³ The disease is characterized by altered mental status, oculomotor findings, and ataxia. ³ Patients with WKS may exhibit challenging behaviors, including aggression, disinhibition, and lack of awareness of their illness. ⁴ Due to long-standing cognitive and physical deficits, many patients require lifelong care with a focus on a palliative approach. ³

The mainstay of pharmacologic management for the neuropsychiatric symptoms of WKS continues to be psychoactive medications, such as antipsychotics, benzodiazepines, antidepressants, and anticonvulsant medications.^4-6 Though atypical antipsychotic medications remain the most widely used, they have a high adverse effect (AE) profile.^5,6 Among the potential AEs are metabolic syndrome, anticholinergic effects, QTc prolongation, orthostatic hypotension, extrapyramidal effects, sedation, and falls. There also is a US Food and Drug Administration boxed warning for increased risk of mortality.⁷ With the goal of improving and maintaining patient safety, pharmacologic interventions with lower AEs may be beneficial in the management of the neuropsychiatric symptoms of WKS.

This case describes a veteran who was initially hospitalized due to confusion, ataxia, and nystagmus secondary to chronic alcohol overuse. The aim of the case was to consider the use of acetaminophen in place of psychoactive medications as a way to manage neuropsychiatric symptoms of WKS even when pain was not present.

Case Presentation

A veteran presented to the local US Department of Veterans Affairs (VA) emergency department (ED) due to their spouse’s concern of acute onset confusion and ambulatory difficulties. The veteran’s medical history included extensive alcohol misuse, mild asthma, and diet-controlled hyperlipidemia. On initial evaluation, the veteran displayed symptoms of ataxia and confusion. When asked why the veteran was at the ED, the response was, “I just came to the hospital to find my sister.” Based on their medical history, clinical evaluation, and altered mental status, the veteran was admitted to the acute care medical service with a presumptive diagnosis of WKS.

On admission, the laboratory evaluation revealed normal alanine transaminase (ALT) and aspartate transaminase (AST) levels but markedly elevated γ-glutamyl transferase (GGT) consistent with alcohol toxicity. COVID-19 testing was negative. Magnetic resonance imaging (MRI) of the brain revealed evidence of alterations in the mammillary bodies and moderately severe cortical and cerebellar volume loss suggestive of long-standing alcohol use.

The veteran was hospitalized for 12 days and treated with high-dose IV thiamine, which resulted in improvement of their ophthalmic disorder (nystagmus) and ataxia. However, they continued to exhibit poor recall, confusion, and occasional agitation characterized by verbal outbursts and aggression toward the staff.

The veteran’s spouse worked full time and did not feel capable of providing the necessary follow-up care at home. The safest discharge plan found was to transfer the veteran to the local VA community living center (CLC) for physical therapy and further support of their marked cognitive decline and agitation.

Following admission to the CLC, the veteran was placed in a secured memory unit with staff trained specifically on management of veterans with cognitive impairment and behavioral concerns. As the veteran did not have decisional capacity on admission, the staff arranged a meeting with the spouse. Based on that conversation, the goals of care were to focus on a palliative approach and the hope that the veteran would one day be able to return home to their spouse.

At the CLC, the veteran was initially treated with thiamine 200 mg orally once daily and albuterol inhaler as needed. A clinical psychologist performed a comprehensive psychological evaluation on admission, which confirmed evidence of WKS with symptoms, including confusion, disorientation, and confabulation. There was no evidence of cultural diversity factors regarding the veteran’s delusional beliefs.

Discussion

Alcohol misuse is a common finding in many US veterans, as well as in the general population.^1,3 As a result, it is not uncommon to see patients with physical and psychological symptoms related to this abuse. Many of these patients will become verbally and physically abusive, thus having appropriate pharmacologic and nonpharmacologic interventions is important.

In this case study, the veteran was diagnosed with WKS and exhibited physical, cognitive, and emotional symptoms consistent with this disease. Although the physical symptoms improved with thiamine and abstinence from alcohol, their cognitive impairment, verbal outbursts, and aggressive demeanor persisted.

After using antipsychotic and anxiolytic medications with minimal clinical improvement, a trial of acetaminophen 650 mg 3 times daily was instituted. The patient’s behavior improved; demeanor became calmer, and they were easily redirected by the nursing staff. Psychological support was again employed, which enhanced and supported the veteran’s calmer demeanor. Although there is limited medical literature on the use of acetaminophen in clinical situations not related to pain, there has been research documenting its effect on social interaction.^9,10

Acetaminophen is an analgesic medication that acts through central neural mechanisms. It has been hypothesized that social and physical pain rely on shared neurochemical underpinnings, and some of the regions of the brain involved in affective experience of physical pain also have been found to be involved in the experience of social pain.¹¹ Acetaminophen may impact an individual’s social well-being as social pain processes.¹¹ It has been shown to blunt reactivity to both physical pain as well as negative stimuli.¹¹

Conclusions

A 2019 survey on alcohol and drug use found 5.6% of adults aged ≥ 18 have an alcohol use disorder.¹² In severe cases, this can result in WKS. Although replacement of thiamine is critical for physical improvement, psychological deficits may persist. Small studies have advanced the concept of using scheduled acetaminophen even when the patient is not verbalizing or displaying pain.¹³ Although more research needs to be done on this topic, this palliative approach may be worth considering, especially if the risks of antipsychotics and anxiolytics outweigh the benefits.

Alcohol is the most common substance misused by veterans. ¹ Veterans may m isuse alcohol as a result of mental illness or posttraumatic stress disorder (PTSD), having difficulties adjusting to civilian life, or because of heavy drinking habits acquired before leaving active duty. ² One potential long-term effect of chronic alcohol misuse is Wernicke-Korsakoff syndrome (WKS), a neuropsychiatric condition secondary to a deficiency of thiamine. ³ The disease is characterized by altered mental status, oculomotor findings, and ataxia. ³ Patients with WKS may exhibit challenging behaviors, including aggression, disinhibition, and lack of awareness of their illness. ⁴ Due to long-standing cognitive and physical deficits, many patients require lifelong care with a focus on a palliative approach. ³

The mainstay of pharmacologic management for the neuropsychiatric symptoms of WKS continues to be psychoactive medications, such as antipsychotics, benzodiazepines, antidepressants, and anticonvulsant medications.^4-6 Though atypical antipsychotic medications remain the most widely used, they have a high adverse effect (AE) profile.^5,6 Among the potential AEs are metabolic syndrome, anticholinergic effects, QTc prolongation, orthostatic hypotension, extrapyramidal effects, sedation, and falls. There also is a US Food and Drug Administration boxed warning for increased risk of mortality.⁷ With the goal of improving and maintaining patient safety, pharmacologic interventions with lower AEs may be beneficial in the management of the neuropsychiatric symptoms of WKS.

This case describes a veteran who was initially hospitalized due to confusion, ataxia, and nystagmus secondary to chronic alcohol overuse. The aim of the case was to consider the use of acetaminophen in place of psychoactive medications as a way to manage neuropsychiatric symptoms of WKS even when pain was not present.

Case Presentation

A veteran presented to the local US Department of Veterans Affairs (VA) emergency department (ED) due to their spouse’s concern of acute onset confusion and ambulatory difficulties. The veteran’s medical history included extensive alcohol misuse, mild asthma, and diet-controlled hyperlipidemia. On initial evaluation, the veteran displayed symptoms of ataxia and confusion. When asked why the veteran was at the ED, the response was, “I just came to the hospital to find my sister.” Based on their medical history, clinical evaluation, and altered mental status, the veteran was admitted to the acute care medical service with a presumptive diagnosis of WKS.

On admission, the laboratory evaluation revealed normal alanine transaminase (ALT) and aspartate transaminase (AST) levels but markedly elevated γ-glutamyl transferase (GGT) consistent with alcohol toxicity. COVID-19 testing was negative. Magnetic resonance imaging (MRI) of the brain revealed evidence of alterations in the mammillary bodies and moderately severe cortical and cerebellar volume loss suggestive of long-standing alcohol use.

The veteran was hospitalized for 12 days and treated with high-dose IV thiamine, which resulted in improvement of their ophthalmic disorder (nystagmus) and ataxia. However, they continued to exhibit poor recall, confusion, and occasional agitation characterized by verbal outbursts and aggression toward the staff.

The veteran’s spouse worked full time and did not feel capable of providing the necessary follow-up care at home. The safest discharge plan found was to transfer the veteran to the local VA community living center (CLC) for physical therapy and further support of their marked cognitive decline and agitation.

Following admission to the CLC, the veteran was placed in a secured memory unit with staff trained specifically on management of veterans with cognitive impairment and behavioral concerns. As the veteran did not have decisional capacity on admission, the staff arranged a meeting with the spouse. Based on that conversation, the goals of care were to focus on a palliative approach and the hope that the veteran would one day be able to return home to their spouse.

At the CLC, the veteran was initially treated with thiamine 200 mg orally once daily and albuterol inhaler as needed. A clinical psychologist performed a comprehensive psychological evaluation on admission, which confirmed evidence of WKS with symptoms, including confusion, disorientation, and confabulation. There was no evidence of cultural diversity factors regarding the veteran’s delusional beliefs.

Discussion

Alcohol misuse is a common finding in many US veterans, as well as in the general population.^1,3 As a result, it is not uncommon to see patients with physical and psychological symptoms related to this abuse. Many of these patients will become verbally and physically abusive, thus having appropriate pharmacologic and nonpharmacologic interventions is important.

In this case study, the veteran was diagnosed with WKS and exhibited physical, cognitive, and emotional symptoms consistent with this disease. Although the physical symptoms improved with thiamine and abstinence from alcohol, their cognitive impairment, verbal outbursts, and aggressive demeanor persisted.

After using antipsychotic and anxiolytic medications with minimal clinical improvement, a trial of acetaminophen 650 mg 3 times daily was instituted. The patient’s behavior improved; demeanor became calmer, and they were easily redirected by the nursing staff. Psychological support was again employed, which enhanced and supported the veteran’s calmer demeanor. Although there is limited medical literature on the use of acetaminophen in clinical situations not related to pain, there has been research documenting its effect on social interaction.^9,10

Acetaminophen is an analgesic medication that acts through central neural mechanisms. It has been hypothesized that social and physical pain rely on shared neurochemical underpinnings, and some of the regions of the brain involved in affective experience of physical pain also have been found to be involved in the experience of social pain.¹¹ Acetaminophen may impact an individual’s social well-being as social pain processes.¹¹ It has been shown to blunt reactivity to both physical pain as well as negative stimuli.¹¹

Conclusions

A 2019 survey on alcohol and drug use found 5.6% of adults aged ≥ 18 have an alcohol use disorder.¹² In severe cases, this can result in WKS. Although replacement of thiamine is critical for physical improvement, psychological deficits may persist. Small studies have advanced the concept of using scheduled acetaminophen even when the patient is not verbalizing or displaying pain.¹³ Although more research needs to be done on this topic, this palliative approach may be worth considering, especially if the risks of antipsychotics and anxiolytics outweigh the benefits.

Alcohol is the most common substance misused by veterans. ¹ Veterans may m isuse alcohol as a result of mental illness or posttraumatic stress disorder (PTSD), having difficulties adjusting to civilian life, or because of heavy drinking habits acquired before leaving active duty. ² One potential long-term effect of chronic alcohol misuse is Wernicke-Korsakoff syndrome (WKS), a neuropsychiatric condition secondary to a deficiency of thiamine. ³ The disease is characterized by altered mental status, oculomotor findings, and ataxia. ³ Patients with WKS may exhibit challenging behaviors, including aggression, disinhibition, and lack of awareness of their illness. ⁴ Due to long-standing cognitive and physical deficits, many patients require lifelong care with a focus on a palliative approach. ³

The mainstay of pharmacologic management for the neuropsychiatric symptoms of WKS continues to be psychoactive medications, such as antipsychotics, benzodiazepines, antidepressants, and anticonvulsant medications.^4-6 Though atypical antipsychotic medications remain the most widely used, they have a high adverse effect (AE) profile.^5,6 Among the potential AEs are metabolic syndrome, anticholinergic effects, QTc prolongation, orthostatic hypotension, extrapyramidal effects, sedation, and falls. There also is a US Food and Drug Administration boxed warning for increased risk of mortality.⁷ With the goal of improving and maintaining patient safety, pharmacologic interventions with lower AEs may be beneficial in the management of the neuropsychiatric symptoms of WKS.

This case describes a veteran who was initially hospitalized due to confusion, ataxia, and nystagmus secondary to chronic alcohol overuse. The aim of the case was to consider the use of acetaminophen in place of psychoactive medications as a way to manage neuropsychiatric symptoms of WKS even when pain was not present.

Case Presentation

A veteran presented to the local US Department of Veterans Affairs (VA) emergency department (ED) due to their spouse’s concern of acute onset confusion and ambulatory difficulties. The veteran’s medical history included extensive alcohol misuse, mild asthma, and diet-controlled hyperlipidemia. On initial evaluation, the veteran displayed symptoms of ataxia and confusion. When asked why the veteran was at the ED, the response was, “I just came to the hospital to find my sister.” Based on their medical history, clinical evaluation, and altered mental status, the veteran was admitted to the acute care medical service with a presumptive diagnosis of WKS.

On admission, the laboratory evaluation revealed normal alanine transaminase (ALT) and aspartate transaminase (AST) levels but markedly elevated γ-glutamyl transferase (GGT) consistent with alcohol toxicity. COVID-19 testing was negative. Magnetic resonance imaging (MRI) of the brain revealed evidence of alterations in the mammillary bodies and moderately severe cortical and cerebellar volume loss suggestive of long-standing alcohol use.

The veteran was hospitalized for 12 days and treated with high-dose IV thiamine, which resulted in improvement of their ophthalmic disorder (nystagmus) and ataxia. However, they continued to exhibit poor recall, confusion, and occasional agitation characterized by verbal outbursts and aggression toward the staff.

The veteran’s spouse worked full time and did not feel capable of providing the necessary follow-up care at home. The safest discharge plan found was to transfer the veteran to the local VA community living center (CLC) for physical therapy and further support of their marked cognitive decline and agitation.

Following admission to the CLC, the veteran was placed in a secured memory unit with staff trained specifically on management of veterans with cognitive impairment and behavioral concerns. As the veteran did not have decisional capacity on admission, the staff arranged a meeting with the spouse. Based on that conversation, the goals of care were to focus on a palliative approach and the hope that the veteran would one day be able to return home to their spouse.

At the CLC, the veteran was initially treated with thiamine 200 mg orally once daily and albuterol inhaler as needed. A clinical psychologist performed a comprehensive psychological evaluation on admission, which confirmed evidence of WKS with symptoms, including confusion, disorientation, and confabulation. There was no evidence of cultural diversity factors regarding the veteran’s delusional beliefs.

Discussion

Alcohol misuse is a common finding in many US veterans, as well as in the general population.^1,3 As a result, it is not uncommon to see patients with physical and psychological symptoms related to this abuse. Many of these patients will become verbally and physically abusive, thus having appropriate pharmacologic and nonpharmacologic interventions is important.

In this case study, the veteran was diagnosed with WKS and exhibited physical, cognitive, and emotional symptoms consistent with this disease. Although the physical symptoms improved with thiamine and abstinence from alcohol, their cognitive impairment, verbal outbursts, and aggressive demeanor persisted.

After using antipsychotic and anxiolytic medications with minimal clinical improvement, a trial of acetaminophen 650 mg 3 times daily was instituted. The patient’s behavior improved; demeanor became calmer, and they were easily redirected by the nursing staff. Psychological support was again employed, which enhanced and supported the veteran’s calmer demeanor. Although there is limited medical literature on the use of acetaminophen in clinical situations not related to pain, there has been research documenting its effect on social interaction.^9,10

Acetaminophen is an analgesic medication that acts through central neural mechanisms. It has been hypothesized that social and physical pain rely on shared neurochemical underpinnings, and some of the regions of the brain involved in affective experience of physical pain also have been found to be involved in the experience of social pain.¹¹ Acetaminophen may impact an individual’s social well-being as social pain processes.¹¹ It has been shown to blunt reactivity to both physical pain as well as negative stimuli.¹¹

Conclusions

A 2019 survey on alcohol and drug use found 5.6% of adults aged ≥ 18 have an alcohol use disorder.¹² In severe cases, this can result in WKS. Although replacement of thiamine is critical for physical improvement, psychological deficits may persist. Small studies have advanced the concept of using scheduled acetaminophen even when the patient is not verbalizing or displaying pain.¹³ Although more research needs to be done on this topic, this palliative approach may be worth considering, especially if the risks of antipsychotics and anxiolytics outweigh the benefits.

If you don’t think it’s important to assess for sleep disorders in your patients with atopic dermatitis (AD), think again.

According to Sabra M. Abbott, MD, PhD, professor of neurology at Northwestern University, Chicago, AD is associated with difficulty falling asleep, nighttime awakenings, early morning awakenings, increased daytime sleepiness, decreased sleep efficiency, increased arousals, awakenings, and sleep fragmentation, as well as increased night kicks and nocturnal leg cramps, and a more than twofold increased risk for insomnia.

During the Revolutionizing Atopic Dermatitis symposium, she offered key questions to ask AD patients who present with sleep complaints:

When do you go to bed? “This does not refer to when you get into bed, but when do you actually go to bed with an intention to go to sleep, outside of watching television or answering emails?” Dr. Abbott said.

How long does it take for you to fall asleep?

Do you wake up in the middle of the night, and for how long? What do you do if you wake up?

When do you wake up in the morning? Is it on your own, or with an alarm clock?

Does this schedule change on nonworkdays?

Do you have daytime impairment? Meaning, do your sleep complaints impact how you function during the daytime?

Do you snore? Meaning, is there concern for sleep apnea?

Do you have uncomfortable sensations in your legs? Are they worse in the evening and improve with movement? These are signs of possible restless legs syndrome.

The Epworth Sleepiness Scale is one self-administered questionnaire to consider using for AD patients with sleep complaints. “This provides patients with several examples of typical scenarios they might encounter during the day and queries whether or not they feel that they could deal with any of those scenarios,” Dr. Abbott said. “A score of greater than 10 indicates that they are sleepy; it’s not just an overall sense of fatigue and decreased energy.”

Other brief self-assessment tools she recommended are the Insomnia Severity Index and the STOP-Bang questionnaire.

Dr. Abbott reported having no financial disclosures.

[email protected]

If you don’t think it’s important to assess for sleep disorders in your patients with atopic dermatitis (AD), think again.

According to Sabra M. Abbott, MD, PhD, professor of neurology at Northwestern University, Chicago, AD is associated with difficulty falling asleep, nighttime awakenings, early morning awakenings, increased daytime sleepiness, decreased sleep efficiency, increased arousals, awakenings, and sleep fragmentation, as well as increased night kicks and nocturnal leg cramps, and a more than twofold increased risk for insomnia.

During the Revolutionizing Atopic Dermatitis symposium, she offered key questions to ask AD patients who present with sleep complaints:

When do you go to bed? “This does not refer to when you get into bed, but when do you actually go to bed with an intention to go to sleep, outside of watching television or answering emails?” Dr. Abbott said.

How long does it take for you to fall asleep?

Do you wake up in the middle of the night, and for how long? What do you do if you wake up?

When do you wake up in the morning? Is it on your own, or with an alarm clock?

Does this schedule change on nonworkdays?

Do you have daytime impairment? Meaning, do your sleep complaints impact how you function during the daytime?

Do you snore? Meaning, is there concern for sleep apnea?

Do you have uncomfortable sensations in your legs? Are they worse in the evening and improve with movement? These are signs of possible restless legs syndrome.

The Epworth Sleepiness Scale is one self-administered questionnaire to consider using for AD patients with sleep complaints. “This provides patients with several examples of typical scenarios they might encounter during the day and queries whether or not they feel that they could deal with any of those scenarios,” Dr. Abbott said. “A score of greater than 10 indicates that they are sleepy; it’s not just an overall sense of fatigue and decreased energy.”

Other brief self-assessment tools she recommended are the Insomnia Severity Index and the STOP-Bang questionnaire.

Dr. Abbott reported having no financial disclosures.

[email protected]

If you don’t think it’s important to assess for sleep disorders in your patients with atopic dermatitis (AD), think again.

According to Sabra M. Abbott, MD, PhD, professor of neurology at Northwestern University, Chicago, AD is associated with difficulty falling asleep, nighttime awakenings, early morning awakenings, increased daytime sleepiness, decreased sleep efficiency, increased arousals, awakenings, and sleep fragmentation, as well as increased night kicks and nocturnal leg cramps, and a more than twofold increased risk for insomnia.

During the Revolutionizing Atopic Dermatitis symposium, she offered key questions to ask AD patients who present with sleep complaints:

When do you go to bed? “This does not refer to when you get into bed, but when do you actually go to bed with an intention to go to sleep, outside of watching television or answering emails?” Dr. Abbott said.

How long does it take for you to fall asleep?

Do you wake up in the middle of the night, and for how long? What do you do if you wake up?

When do you wake up in the morning? Is it on your own, or with an alarm clock?

Does this schedule change on nonworkdays?

Do you have daytime impairment? Meaning, do your sleep complaints impact how you function during the daytime?

Do you snore? Meaning, is there concern for sleep apnea?

Do you have uncomfortable sensations in your legs? Are they worse in the evening and improve with movement? These are signs of possible restless legs syndrome.

The Epworth Sleepiness Scale is one self-administered questionnaire to consider using for AD patients with sleep complaints. “This provides patients with several examples of typical scenarios they might encounter during the day and queries whether or not they feel that they could deal with any of those scenarios,” Dr. Abbott said. “A score of greater than 10 indicates that they are sleepy; it’s not just an overall sense of fatigue and decreased energy.”

Other brief self-assessment tools she recommended are the Insomnia Severity Index and the STOP-Bang questionnaire.

Dr. Abbott reported having no financial disclosures.

[email protected]

A specialty group is asking federal and state governments to preserve and expand access to telehealth services for children with developmental and behavioral problems.

Citing the success during the COVID-19 pandemic of telehealth for these patients, the Society for Developmental and Behavioral Pediatrics (SDBP) has issued a position statement in its official journal calling for continued use of video and telephone for home-based diagnostic assessments, medication management follow-ups, and therapeutic interventions for children  with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental conditions.

“Telehealth offers plenty of opportunities for quick check-ins. It can offer some crisis management opportunities ... to address a parent’s concern about challenging behaviors or navigating school system issues or developmental needs,” lead author Robert D. Keder, MD, assistant professor of pediatrics at University of Connecticut, Farmington, and cochair of SDBP’s Advocacy Committee, told this news organization.

“The video visit does really offer us so much more. It’s so enriching and lets us as providers meet the child in their natural home environment. The real magic of a video visit is we haven’t done house calls as a medical society for decades. But now, literally, the power of telehealth lets us do a house call.”

In the face of the pandemic, emergency government policies allowed care to continue remotely via telehealth, including video and phone calls. The policies have allowed patients to have video visits in their own home, lifted provider licensure requirements for visits across state lines, and allowed reimbursement not only for video visits but also for telephone encounters.

As a result, the field of developmental and behavioral pediatrics (DBP) has recognized telehealth as a viable and useful model of care for children with neurodevelopmental disorders, said Neelkamal Soares, MD, a member of the society’s board and a coauthor of the position paper.

“Telehealth has been helpful in mitigating barriers families often face when attending in-person visits,” such as the lack of transportation and child care, missed work hours, and other issues, said Dr. Soares, professor of pediatric and adolescent medicine at Western Michigan University Stryker in Kalamazoo. At the same time, the growth in the use of the technology has highlighted additional obstacles to equitable access to care, including broadband connectivity, digital literacy, and the availability of interpretation and sign language services, he said.

Dr. Keder said telehealth has enabled him to better help with behavior management by observing children where they are most comfortable. Remote visits also allow him to consider information such as furniture arrangements and how that can affect the patient’s living conditions, and also sibling interactions, learning and homework, eating, and sleep.

Telemedicine conferences enable DBP specialists to facilitate care collaboration with different members of the patient’s care team. Consent from a family and a click of a button allows for therapists, early intervention specialists, teachers, school nurses, or even primary care providers the capacity to participate in a telehealth visit, he said.

Dr. Keder said the future of telehealth is uncertain. The policies from the pandemic may expire in the near term and vary from state to state. The goal of the policy statement is to advocate for legislation and policies that support ongoing, equitable, home-based telehealth care for patients seen by DBP providers while ensuring equitable access to DBP in general.

Kate Benton, PhD, a clinical psychologist with Lurie Children’s Hospital at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., said the society has done an excellent job of explaining the need to maintain telehealth in light of the shortage of pediatricians, clinical psychologists, and other professionals in the field.

“Telehealth has opened new avenues for these patients who otherwise have difficulty seeing specialists. This is a population of children who without telehealth have significant challenges in getting access to care,” she said.

Wendy Fournier, mother of an autistic child and president of the National Autism Association, said telehealth can be beneficial for some individuals with the disorder.

“There are many aspects of in-person doctor visits that can be overwhelming, including bright lights, many people talking, waiting for the doctor, being comfortable with the doctor’s touch, etc.,” Ms. Fournier said in an interview. “All of these things can cause sensory and emotional dysregulation leading to overwhelming anxiety and fear.”

Visits to the doctor can be especially difficult for people who are nonverbal and unable to express their discomfort, said. 

“At my daughter’s last medical appointment, she could not stay in the exam room and pulled me out the door. Thankfully, we have an understanding and compassionate physician who finished our appointment in our car. I believe that telehealth visits should remain available as a necessary and vital accommodation for people with disabilities,” Ms. Fournier said.
 

False equivalence?

Dr. Soares said researchers have attempted to assess the evidence of telehealth benefits in such situations as ADHD, cognitive behavioral therapy, and parent training. 

“There is a paucity of published studies that specifically look at different conditions and compare in-person to telehealth visits, but these are ongoing in autism diagnostics and other areas by several SDBP members,” he said. “Stay tuned.”

Dr. Keder added that telehealth will never replace in-person visits, but the availability of this new option gives developmental pediatricians flexibility in strategies in treating and evaluating patients.

“Both are helpful and viable models. In the pandemic, we were forced out of necessity to embrace telehealth,” he said. “Because of this, we are seeing the power and benefits telehealth offers. Now many families like a mixture of alternating in person with telehealth visits.”

The policy statement cites research that finds patients are highly satisfied with telehealth and that telehealth may cost less than in-office visits.

The report stresses that equitable access to devices needed for telehealth visits is a concern because there is disproportionate access to required technology, especially in rural and underserved communities. The Federal Communications Commission has provided grants to eligible families to offset the cost, in part, for a laptop, desktop computer, or tablet. However, more is still needed, the group said.

The position paper calls for:

• Equitable access to the infrastructure and technology for telehealth, including greater access to broadband services in rural and underserved areas.
• Increased access to devices needed to connect children with neurodevelopmental disorders with critical health care services.
• Reimbursement of interpretation services for the people who are deaf and/or have limited English proficiency.
• Mitigation of geographic barriers to accessing DBP care.
• Permitting patients to access telehealth from their home or whichever physical location provides opportunities for safe and timely care, especially for established patients.
• Ensuring more engagement by state medical licensing boards to join the Interstate Medical Licensing Compact to provide care by telehealth when there is already an insufficient geographic distribution of that type of provider in a state, as is being conducted in the field of psychology.
• Ensuring ongoing reimbursement.
• Parity in reimbursement for telehealth in-person visits.
• Increased funding for research looking into outcomes, quality, and effectiveness of telehealth services at the federal and state levels.

“Our organization can work with families to educate lawmakers, insurance administrators, and organizational leaders about the value that telehealth holds in the care of their child and family,” Dr. Soares said. “We can also conduct research to add to the evidence based around the topic to further the science around telehealth outcomes and equivalency to in-person settings.”

“With the current workforce shortage in DBP and behavioral health it is more critical than ever to maintain access to care,” Dr. Keder added. “The pandemic has provided an opportunity to better harness the amazing power of telehealth to allow for access to equitable care for families. We hope that this statement moves legislators, leaders, and voters to continue to advocate for ongoing telehealth at both the state, federal, and organizational levels.”

Dr. Benton, Dr. Keder, and Dr. Soares have disclosed no financial conflicts of interest.

A version of this article first appeared on Medscape.com.

A specialty group is asking federal and state governments to preserve and expand access to telehealth services for children with developmental and behavioral problems.

Citing the success during the COVID-19 pandemic of telehealth for these patients, the Society for Developmental and Behavioral Pediatrics (SDBP) has issued a position statement in its official journal calling for continued use of video and telephone for home-based diagnostic assessments, medication management follow-ups, and therapeutic interventions for children  with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental conditions.

“Telehealth offers plenty of opportunities for quick check-ins. It can offer some crisis management opportunities ... to address a parent’s concern about challenging behaviors or navigating school system issues or developmental needs,” lead author Robert D. Keder, MD, assistant professor of pediatrics at University of Connecticut, Farmington, and cochair of SDBP’s Advocacy Committee, told this news organization.

“The video visit does really offer us so much more. It’s so enriching and lets us as providers meet the child in their natural home environment. The real magic of a video visit is we haven’t done house calls as a medical society for decades. But now, literally, the power of telehealth lets us do a house call.”

In the face of the pandemic, emergency government policies allowed care to continue remotely via telehealth, including video and phone calls. The policies have allowed patients to have video visits in their own home, lifted provider licensure requirements for visits across state lines, and allowed reimbursement not only for video visits but also for telephone encounters.

As a result, the field of developmental and behavioral pediatrics (DBP) has recognized telehealth as a viable and useful model of care for children with neurodevelopmental disorders, said Neelkamal Soares, MD, a member of the society’s board and a coauthor of the position paper.

“Telehealth has been helpful in mitigating barriers families often face when attending in-person visits,” such as the lack of transportation and child care, missed work hours, and other issues, said Dr. Soares, professor of pediatric and adolescent medicine at Western Michigan University Stryker in Kalamazoo. At the same time, the growth in the use of the technology has highlighted additional obstacles to equitable access to care, including broadband connectivity, digital literacy, and the availability of interpretation and sign language services, he said.

Dr. Keder said telehealth has enabled him to better help with behavior management by observing children where they are most comfortable. Remote visits also allow him to consider information such as furniture arrangements and how that can affect the patient’s living conditions, and also sibling interactions, learning and homework, eating, and sleep.

Telemedicine conferences enable DBP specialists to facilitate care collaboration with different members of the patient’s care team. Consent from a family and a click of a button allows for therapists, early intervention specialists, teachers, school nurses, or even primary care providers the capacity to participate in a telehealth visit, he said.

Dr. Keder said the future of telehealth is uncertain. The policies from the pandemic may expire in the near term and vary from state to state. The goal of the policy statement is to advocate for legislation and policies that support ongoing, equitable, home-based telehealth care for patients seen by DBP providers while ensuring equitable access to DBP in general.

Kate Benton, PhD, a clinical psychologist with Lurie Children’s Hospital at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., said the society has done an excellent job of explaining the need to maintain telehealth in light of the shortage of pediatricians, clinical psychologists, and other professionals in the field.

“Telehealth has opened new avenues for these patients who otherwise have difficulty seeing specialists. This is a population of children who without telehealth have significant challenges in getting access to care,” she said.

Wendy Fournier, mother of an autistic child and president of the National Autism Association, said telehealth can be beneficial for some individuals with the disorder.

“There are many aspects of in-person doctor visits that can be overwhelming, including bright lights, many people talking, waiting for the doctor, being comfortable with the doctor’s touch, etc.,” Ms. Fournier said in an interview. “All of these things can cause sensory and emotional dysregulation leading to overwhelming anxiety and fear.”

Visits to the doctor can be especially difficult for people who are nonverbal and unable to express their discomfort, said. 

“At my daughter’s last medical appointment, she could not stay in the exam room and pulled me out the door. Thankfully, we have an understanding and compassionate physician who finished our appointment in our car. I believe that telehealth visits should remain available as a necessary and vital accommodation for people with disabilities,” Ms. Fournier said.
 

False equivalence?

Dr. Soares said researchers have attempted to assess the evidence of telehealth benefits in such situations as ADHD, cognitive behavioral therapy, and parent training. 

“There is a paucity of published studies that specifically look at different conditions and compare in-person to telehealth visits, but these are ongoing in autism diagnostics and other areas by several SDBP members,” he said. “Stay tuned.”

Dr. Keder added that telehealth will never replace in-person visits, but the availability of this new option gives developmental pediatricians flexibility in strategies in treating and evaluating patients.

“Both are helpful and viable models. In the pandemic, we were forced out of necessity to embrace telehealth,” he said. “Because of this, we are seeing the power and benefits telehealth offers. Now many families like a mixture of alternating in person with telehealth visits.”

The policy statement cites research that finds patients are highly satisfied with telehealth and that telehealth may cost less than in-office visits.

The report stresses that equitable access to devices needed for telehealth visits is a concern because there is disproportionate access to required technology, especially in rural and underserved communities. The Federal Communications Commission has provided grants to eligible families to offset the cost, in part, for a laptop, desktop computer, or tablet. However, more is still needed, the group said.

The position paper calls for:

• Equitable access to the infrastructure and technology for telehealth, including greater access to broadband services in rural and underserved areas.
• Increased access to devices needed to connect children with neurodevelopmental disorders with critical health care services.
• Reimbursement of interpretation services for the people who are deaf and/or have limited English proficiency.
• Mitigation of geographic barriers to accessing DBP care.
• Permitting patients to access telehealth from their home or whichever physical location provides opportunities for safe and timely care, especially for established patients.
• Ensuring more engagement by state medical licensing boards to join the Interstate Medical Licensing Compact to provide care by telehealth when there is already an insufficient geographic distribution of that type of provider in a state, as is being conducted in the field of psychology.
• Ensuring ongoing reimbursement.
• Parity in reimbursement for telehealth in-person visits.
• Increased funding for research looking into outcomes, quality, and effectiveness of telehealth services at the federal and state levels.

“Our organization can work with families to educate lawmakers, insurance administrators, and organizational leaders about the value that telehealth holds in the care of their child and family,” Dr. Soares said. “We can also conduct research to add to the evidence based around the topic to further the science around telehealth outcomes and equivalency to in-person settings.”

“With the current workforce shortage in DBP and behavioral health it is more critical than ever to maintain access to care,” Dr. Keder added. “The pandemic has provided an opportunity to better harness the amazing power of telehealth to allow for access to equitable care for families. We hope that this statement moves legislators, leaders, and voters to continue to advocate for ongoing telehealth at both the state, federal, and organizational levels.”

Dr. Benton, Dr. Keder, and Dr. Soares have disclosed no financial conflicts of interest.

A version of this article first appeared on Medscape.com.

A specialty group is asking federal and state governments to preserve and expand access to telehealth services for children with developmental and behavioral problems.

Citing the success during the COVID-19 pandemic of telehealth for these patients, the Society for Developmental and Behavioral Pediatrics (SDBP) has issued a position statement in its official journal calling for continued use of video and telephone for home-based diagnostic assessments, medication management follow-ups, and therapeutic interventions for children  with autism spectrum disorder, attention-deficit/hyperactivity disorder, and other neurodevelopmental conditions.

“Telehealth offers plenty of opportunities for quick check-ins. It can offer some crisis management opportunities ... to address a parent’s concern about challenging behaviors or navigating school system issues or developmental needs,” lead author Robert D. Keder, MD, assistant professor of pediatrics at University of Connecticut, Farmington, and cochair of SDBP’s Advocacy Committee, told this news organization.

“The video visit does really offer us so much more. It’s so enriching and lets us as providers meet the child in their natural home environment. The real magic of a video visit is we haven’t done house calls as a medical society for decades. But now, literally, the power of telehealth lets us do a house call.”

In the face of the pandemic, emergency government policies allowed care to continue remotely via telehealth, including video and phone calls. The policies have allowed patients to have video visits in their own home, lifted provider licensure requirements for visits across state lines, and allowed reimbursement not only for video visits but also for telephone encounters.

As a result, the field of developmental and behavioral pediatrics (DBP) has recognized telehealth as a viable and useful model of care for children with neurodevelopmental disorders, said Neelkamal Soares, MD, a member of the society’s board and a coauthor of the position paper.

“Telehealth has been helpful in mitigating barriers families often face when attending in-person visits,” such as the lack of transportation and child care, missed work hours, and other issues, said Dr. Soares, professor of pediatric and adolescent medicine at Western Michigan University Stryker in Kalamazoo. At the same time, the growth in the use of the technology has highlighted additional obstacles to equitable access to care, including broadband connectivity, digital literacy, and the availability of interpretation and sign language services, he said.

Dr. Keder said telehealth has enabled him to better help with behavior management by observing children where they are most comfortable. Remote visits also allow him to consider information such as furniture arrangements and how that can affect the patient’s living conditions, and also sibling interactions, learning and homework, eating, and sleep.

Telemedicine conferences enable DBP specialists to facilitate care collaboration with different members of the patient’s care team. Consent from a family and a click of a button allows for therapists, early intervention specialists, teachers, school nurses, or even primary care providers the capacity to participate in a telehealth visit, he said.

Dr. Keder said the future of telehealth is uncertain. The policies from the pandemic may expire in the near term and vary from state to state. The goal of the policy statement is to advocate for legislation and policies that support ongoing, equitable, home-based telehealth care for patients seen by DBP providers while ensuring equitable access to DBP in general.

Kate Benton, PhD, a clinical psychologist with Lurie Children’s Hospital at Northwestern Medicine Central DuPage Hospital in Winfield, Ill., said the society has done an excellent job of explaining the need to maintain telehealth in light of the shortage of pediatricians, clinical psychologists, and other professionals in the field.

“Telehealth has opened new avenues for these patients who otherwise have difficulty seeing specialists. This is a population of children who without telehealth have significant challenges in getting access to care,” she said.

Wendy Fournier, mother of an autistic child and president of the National Autism Association, said telehealth can be beneficial for some individuals with the disorder.

“There are many aspects of in-person doctor visits that can be overwhelming, including bright lights, many people talking, waiting for the doctor, being comfortable with the doctor’s touch, etc.,” Ms. Fournier said in an interview. “All of these things can cause sensory and emotional dysregulation leading to overwhelming anxiety and fear.”

Visits to the doctor can be especially difficult for people who are nonverbal and unable to express their discomfort, said. 

“At my daughter’s last medical appointment, she could not stay in the exam room and pulled me out the door. Thankfully, we have an understanding and compassionate physician who finished our appointment in our car. I believe that telehealth visits should remain available as a necessary and vital accommodation for people with disabilities,” Ms. Fournier said.
 

False equivalence?

Dr. Soares said researchers have attempted to assess the evidence of telehealth benefits in such situations as ADHD, cognitive behavioral therapy, and parent training. 

“There is a paucity of published studies that specifically look at different conditions and compare in-person to telehealth visits, but these are ongoing in autism diagnostics and other areas by several SDBP members,” he said. “Stay tuned.”

Dr. Keder added that telehealth will never replace in-person visits, but the availability of this new option gives developmental pediatricians flexibility in strategies in treating and evaluating patients.

“Both are helpful and viable models. In the pandemic, we were forced out of necessity to embrace telehealth,” he said. “Because of this, we are seeing the power and benefits telehealth offers. Now many families like a mixture of alternating in person with telehealth visits.”

The policy statement cites research that finds patients are highly satisfied with telehealth and that telehealth may cost less than in-office visits.

The report stresses that equitable access to devices needed for telehealth visits is a concern because there is disproportionate access to required technology, especially in rural and underserved communities. The Federal Communications Commission has provided grants to eligible families to offset the cost, in part, for a laptop, desktop computer, or tablet. However, more is still needed, the group said.

The position paper calls for:

• Equitable access to the infrastructure and technology for telehealth, including greater access to broadband services in rural and underserved areas.
• Increased access to devices needed to connect children with neurodevelopmental disorders with critical health care services.
• Reimbursement of interpretation services for the people who are deaf and/or have limited English proficiency.
• Mitigation of geographic barriers to accessing DBP care.
• Permitting patients to access telehealth from their home or whichever physical location provides opportunities for safe and timely care, especially for established patients.
• Ensuring more engagement by state medical licensing boards to join the Interstate Medical Licensing Compact to provide care by telehealth when there is already an insufficient geographic distribution of that type of provider in a state, as is being conducted in the field of psychology.
• Ensuring ongoing reimbursement.
• Parity in reimbursement for telehealth in-person visits.
• Increased funding for research looking into outcomes, quality, and effectiveness of telehealth services at the federal and state levels.

“Our organization can work with families to educate lawmakers, insurance administrators, and organizational leaders about the value that telehealth holds in the care of their child and family,” Dr. Soares said. “We can also conduct research to add to the evidence based around the topic to further the science around telehealth outcomes and equivalency to in-person settings.”

“With the current workforce shortage in DBP and behavioral health it is more critical than ever to maintain access to care,” Dr. Keder added. “The pandemic has provided an opportunity to better harness the amazing power of telehealth to allow for access to equitable care for families. We hope that this statement moves legislators, leaders, and voters to continue to advocate for ongoing telehealth at both the state, federal, and organizational levels.”

Dr. Benton, Dr. Keder, and Dr. Soares have disclosed no financial conflicts of interest.

A version of this article first appeared on Medscape.com.

Even though men in midlife have more cardiovascular (CV) conditions and risk factors than women of the same age, women are more affected by these conditions in terms of cognitive decline, new research suggests.

Analyses of almost 1,400 participants in the population-based Mayo Clinic Study of Aging showed that diabetes, dyslipidemia, and coronary heart disease (CHD) all had stronger associations with global cognitive decline in women than in men.

“All men and women should be treated for cardiovascular risk factors and conditions, but this study really highlights the importance of very early and perhaps more aggressive treatment in women with these conditions,” co-investigator Michelle M. Mielke, PhD, professor of epidemiology and neurology, Mayo Clinic, Rochester, Minn., told this news organization.

The findings were published online Jan. 5 in Neurology.
 

Assessing sex differences

Most previous studies in this area have focused on CV risk factors in midlife in relation to late-life dementia (after age 75) or on late-life vascular risk factors and late-life dementia, Dr. Mielke noted.

However, a few recent studies have suggested vascular risk factors can affect cognition even in midlife. The current investigators sought to determine whether there are sex differences in these associations.

They assessed 1,857 nondemented participants aged 50 to 69 years from the Mayo Clinic Study on Aging. The mean education level was 14.9 years, and the mean body mass index (BMI) was 29.7.

Among the participants, 78.9% had at least one CV condition or risk factor, and the proportion was higher in men than women (83.4% vs. 74.5%; P < .0001).

Frequency of each individual CV condition or risk factor was also higher in men than women, and they had more years of education and higher BMI but took fewer medications.

Every 15 months, participants had an in-person interview and physical examination that included a neurologic assessment and short test of memory.

The neuropsychological battery included nine tests across four domains: memory, language, executive function, and visuospatial skills. Researchers calculated z-scores for these domains and for global cognition.
 

Multiple cognitive domains

Whereas this study evaluated multiple cognitive domains, most previous research has focused on global cognitive decline and/or decline in only one or two cognitive domains, the investigators note.

They collected information from medical records on CV conditions such as CHD, arrhythmias, congestive heart failure, peripheral vascular disease (PVD), and stroke; and CV risk factors such as hypertension, diabetes, dyslipidemia, smoking status, and BMI.

Because of the small number of patients with stroke and PVD, these were classified as “other cardiovascular conditions” in the statistical analysis.

Researchers adjusted for sex, age, years of education, depressive symptoms, comorbidities, medications, and apolipoprotein E (APOE) genotyping. The mean follow-up was 3 years and did not differ by sex.

As some participants didn’t have a follow-up visit, the current analysis included 1,394 individuals. Those without follow-up visits were younger, had less education and more comorbidities, and took more medications compared with those with a follow-up.

Results showed most CV conditions were more strongly associated with cognitive function among women than men. For example, CHD was associated with global decline only in women (P < .05).

CHD, diabetes, and dyslipidemia were associated with language decline in women only (all, P < .05), but congestive heart failure was significantly associated with language decline in men only.

Dr. Mielke cautioned about reading too much into the language results for women.

“It’s an intriguing finding and definitely we need to follow up on it,” she said. However, “more studies are needed to examine sex differences before we start saying it only has an effect on language.”
 

‘Treat aggressively and right away’

The researchers were somewhat surprised by the study findings. Because there is a higher prevalence of CV conditions and risk factors in men, they presumed men would be more affected by these conditions, said Dr. Mielke.

“But that’s not what we saw; we saw the reverse. It was actually the women who were affected more by these cardiovascular risk factors and conditions,” she said.

As midlife is when women enter menopause, fluctuating estrogen levels may help explain the differential impact on cognition among women. But Dr. Mielke said she wants to “move beyond” just looking at hormones.

She pointed out there are a variety of psychosocial factors that may also contribute to an imbalance in the cognitive impact of CV conditions on women.

“Midlife is when many women are still taking care of their children at home, are also taking care of their adult parents, and may be undergoing more stress while continuing to do a job,” Dr. Miekle said.

Structural brain development and genetics may also contribute to the greater effect on cognition in women, the investigators note.

Dr. Mielke stressed that the current study only identifies associations. “The next steps are to understand what some of the underlying mechanisms for this are,” she said.

In the meantime, these new results suggest middle-aged women with high blood pressure, cholesterol, or glucose measures “should be treated aggressively and right away” said Dr. Mielke.

“For example, for women who are just starting to become hypertensive, clinicians should treat them right away and not watch and wait.”

Study limitations cited include that its sample was limited to Olmsted County, Minnesota – so results may not be generalized to other populations. Also, as researchers combined PVD and stroke into one group, larger sample sizes are needed, especially for stroke. Another limitation was the study did not have information on duration of all CV conditions or risk factors.
 

Helpful for tailoring interventions?

Commenting on the study, Glen R. Finney, MD, director, Memory and Cognition Program, Geisinger Health Clinic, Wilkes-Barre, Pennsylvania, said the results are important.

“The more we understand about risk factors for the development of Alzheimer’s disease and related dementias, the better we understand how we can reduce the risks,” said Dr. Finney, who was not involved with the research.

Awareness that CV conditions are major risk factors in midlife has been “definitely rising,” said Dr. Finney. “Many studies originally were looking at late life and are now looking more at earlier in the disease process, and I think that’s important.”

Understanding how sex, ethnicity, and other demographic variables affect risks can help to “tailor interventions” for individual patients, he said.

The study was supported by the National Institutes of Health, the GHR Foundation, and the Rochester Epidemiology Project. Dr. Mielke is a consultant for Biogen and Brain Protection Company and is on the editorial boards of Neurology and Alzheimer’s and Dementia. Dr. Finney has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Even though men in midlife have more cardiovascular (CV) conditions and risk factors than women of the same age, women are more affected by these conditions in terms of cognitive decline, new research suggests.

Analyses of almost 1,400 participants in the population-based Mayo Clinic Study of Aging showed that diabetes, dyslipidemia, and coronary heart disease (CHD) all had stronger associations with global cognitive decline in women than in men.

“All men and women should be treated for cardiovascular risk factors and conditions, but this study really highlights the importance of very early and perhaps more aggressive treatment in women with these conditions,” co-investigator Michelle M. Mielke, PhD, professor of epidemiology and neurology, Mayo Clinic, Rochester, Minn., told this news organization.

The findings were published online Jan. 5 in Neurology.
 

Assessing sex differences

Most previous studies in this area have focused on CV risk factors in midlife in relation to late-life dementia (after age 75) or on late-life vascular risk factors and late-life dementia, Dr. Mielke noted.

However, a few recent studies have suggested vascular risk factors can affect cognition even in midlife. The current investigators sought to determine whether there are sex differences in these associations.

They assessed 1,857 nondemented participants aged 50 to 69 years from the Mayo Clinic Study on Aging. The mean education level was 14.9 years, and the mean body mass index (BMI) was 29.7.

Among the participants, 78.9% had at least one CV condition or risk factor, and the proportion was higher in men than women (83.4% vs. 74.5%; P < .0001).

Frequency of each individual CV condition or risk factor was also higher in men than women, and they had more years of education and higher BMI but took fewer medications.

Every 15 months, participants had an in-person interview and physical examination that included a neurologic assessment and short test of memory.

The neuropsychological battery included nine tests across four domains: memory, language, executive function, and visuospatial skills. Researchers calculated z-scores for these domains and for global cognition.
 

Multiple cognitive domains

Whereas this study evaluated multiple cognitive domains, most previous research has focused on global cognitive decline and/or decline in only one or two cognitive domains, the investigators note.

They collected information from medical records on CV conditions such as CHD, arrhythmias, congestive heart failure, peripheral vascular disease (PVD), and stroke; and CV risk factors such as hypertension, diabetes, dyslipidemia, smoking status, and BMI.

Because of the small number of patients with stroke and PVD, these were classified as “other cardiovascular conditions” in the statistical analysis.

Researchers adjusted for sex, age, years of education, depressive symptoms, comorbidities, medications, and apolipoprotein E (APOE) genotyping. The mean follow-up was 3 years and did not differ by sex.

As some participants didn’t have a follow-up visit, the current analysis included 1,394 individuals. Those without follow-up visits were younger, had less education and more comorbidities, and took more medications compared with those with a follow-up.

Results showed most CV conditions were more strongly associated with cognitive function among women than men. For example, CHD was associated with global decline only in women (P < .05).

CHD, diabetes, and dyslipidemia were associated with language decline in women only (all, P < .05), but congestive heart failure was significantly associated with language decline in men only.

Dr. Mielke cautioned about reading too much into the language results for women.

“It’s an intriguing finding and definitely we need to follow up on it,” she said. However, “more studies are needed to examine sex differences before we start saying it only has an effect on language.”
 

‘Treat aggressively and right away’

The researchers were somewhat surprised by the study findings. Because there is a higher prevalence of CV conditions and risk factors in men, they presumed men would be more affected by these conditions, said Dr. Mielke.

“But that’s not what we saw; we saw the reverse. It was actually the women who were affected more by these cardiovascular risk factors and conditions,” she said.

As midlife is when women enter menopause, fluctuating estrogen levels may help explain the differential impact on cognition among women. But Dr. Mielke said she wants to “move beyond” just looking at hormones.

She pointed out there are a variety of psychosocial factors that may also contribute to an imbalance in the cognitive impact of CV conditions on women.

“Midlife is when many women are still taking care of their children at home, are also taking care of their adult parents, and may be undergoing more stress while continuing to do a job,” Dr. Miekle said.

Structural brain development and genetics may also contribute to the greater effect on cognition in women, the investigators note.

Dr. Mielke stressed that the current study only identifies associations. “The next steps are to understand what some of the underlying mechanisms for this are,” she said.

In the meantime, these new results suggest middle-aged women with high blood pressure, cholesterol, or glucose measures “should be treated aggressively and right away” said Dr. Mielke.

“For example, for women who are just starting to become hypertensive, clinicians should treat them right away and not watch and wait.”

Study limitations cited include that its sample was limited to Olmsted County, Minnesota – so results may not be generalized to other populations. Also, as researchers combined PVD and stroke into one group, larger sample sizes are needed, especially for stroke. Another limitation was the study did not have information on duration of all CV conditions or risk factors.
 

Helpful for tailoring interventions?

Commenting on the study, Glen R. Finney, MD, director, Memory and Cognition Program, Geisinger Health Clinic, Wilkes-Barre, Pennsylvania, said the results are important.

“The more we understand about risk factors for the development of Alzheimer’s disease and related dementias, the better we understand how we can reduce the risks,” said Dr. Finney, who was not involved with the research.

Awareness that CV conditions are major risk factors in midlife has been “definitely rising,” said Dr. Finney. “Many studies originally were looking at late life and are now looking more at earlier in the disease process, and I think that’s important.”

Understanding how sex, ethnicity, and other demographic variables affect risks can help to “tailor interventions” for individual patients, he said.

The study was supported by the National Institutes of Health, the GHR Foundation, and the Rochester Epidemiology Project. Dr. Mielke is a consultant for Biogen and Brain Protection Company and is on the editorial boards of Neurology and Alzheimer’s and Dementia. Dr. Finney has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Even though men in midlife have more cardiovascular (CV) conditions and risk factors than women of the same age, women are more affected by these conditions in terms of cognitive decline, new research suggests.

Analyses of almost 1,400 participants in the population-based Mayo Clinic Study of Aging showed that diabetes, dyslipidemia, and coronary heart disease (CHD) all had stronger associations with global cognitive decline in women than in men.

“All men and women should be treated for cardiovascular risk factors and conditions, but this study really highlights the importance of very early and perhaps more aggressive treatment in women with these conditions,” co-investigator Michelle M. Mielke, PhD, professor of epidemiology and neurology, Mayo Clinic, Rochester, Minn., told this news organization.

The findings were published online Jan. 5 in Neurology.
 

Assessing sex differences

Most previous studies in this area have focused on CV risk factors in midlife in relation to late-life dementia (after age 75) or on late-life vascular risk factors and late-life dementia, Dr. Mielke noted.

However, a few recent studies have suggested vascular risk factors can affect cognition even in midlife. The current investigators sought to determine whether there are sex differences in these associations.

They assessed 1,857 nondemented participants aged 50 to 69 years from the Mayo Clinic Study on Aging. The mean education level was 14.9 years, and the mean body mass index (BMI) was 29.7.

Among the participants, 78.9% had at least one CV condition or risk factor, and the proportion was higher in men than women (83.4% vs. 74.5%; P < .0001).

Frequency of each individual CV condition or risk factor was also higher in men than women, and they had more years of education and higher BMI but took fewer medications.

Every 15 months, participants had an in-person interview and physical examination that included a neurologic assessment and short test of memory.

The neuropsychological battery included nine tests across four domains: memory, language, executive function, and visuospatial skills. Researchers calculated z-scores for these domains and for global cognition.
 

Multiple cognitive domains

Whereas this study evaluated multiple cognitive domains, most previous research has focused on global cognitive decline and/or decline in only one or two cognitive domains, the investigators note.

They collected information from medical records on CV conditions such as CHD, arrhythmias, congestive heart failure, peripheral vascular disease (PVD), and stroke; and CV risk factors such as hypertension, diabetes, dyslipidemia, smoking status, and BMI.

Because of the small number of patients with stroke and PVD, these were classified as “other cardiovascular conditions” in the statistical analysis.

Researchers adjusted for sex, age, years of education, depressive symptoms, comorbidities, medications, and apolipoprotein E (APOE) genotyping. The mean follow-up was 3 years and did not differ by sex.

As some participants didn’t have a follow-up visit, the current analysis included 1,394 individuals. Those without follow-up visits were younger, had less education and more comorbidities, and took more medications compared with those with a follow-up.

Results showed most CV conditions were more strongly associated with cognitive function among women than men. For example, CHD was associated with global decline only in women (P < .05).

CHD, diabetes, and dyslipidemia were associated with language decline in women only (all, P < .05), but congestive heart failure was significantly associated with language decline in men only.

Dr. Mielke cautioned about reading too much into the language results for women.

“It’s an intriguing finding and definitely we need to follow up on it,” she said. However, “more studies are needed to examine sex differences before we start saying it only has an effect on language.”
 

‘Treat aggressively and right away’

The researchers were somewhat surprised by the study findings. Because there is a higher prevalence of CV conditions and risk factors in men, they presumed men would be more affected by these conditions, said Dr. Mielke.

“But that’s not what we saw; we saw the reverse. It was actually the women who were affected more by these cardiovascular risk factors and conditions,” she said.

As midlife is when women enter menopause, fluctuating estrogen levels may help explain the differential impact on cognition among women. But Dr. Mielke said she wants to “move beyond” just looking at hormones.

She pointed out there are a variety of psychosocial factors that may also contribute to an imbalance in the cognitive impact of CV conditions on women.

“Midlife is when many women are still taking care of their children at home, are also taking care of their adult parents, and may be undergoing more stress while continuing to do a job,” Dr. Miekle said.

Structural brain development and genetics may also contribute to the greater effect on cognition in women, the investigators note.

Dr. Mielke stressed that the current study only identifies associations. “The next steps are to understand what some of the underlying mechanisms for this are,” she said.

In the meantime, these new results suggest middle-aged women with high blood pressure, cholesterol, or glucose measures “should be treated aggressively and right away” said Dr. Mielke.

“For example, for women who are just starting to become hypertensive, clinicians should treat them right away and not watch and wait.”

Study limitations cited include that its sample was limited to Olmsted County, Minnesota – so results may not be generalized to other populations. Also, as researchers combined PVD and stroke into one group, larger sample sizes are needed, especially for stroke. Another limitation was the study did not have information on duration of all CV conditions or risk factors.
 

Helpful for tailoring interventions?

Commenting on the study, Glen R. Finney, MD, director, Memory and Cognition Program, Geisinger Health Clinic, Wilkes-Barre, Pennsylvania, said the results are important.

“The more we understand about risk factors for the development of Alzheimer’s disease and related dementias, the better we understand how we can reduce the risks,” said Dr. Finney, who was not involved with the research.

Awareness that CV conditions are major risk factors in midlife has been “definitely rising,” said Dr. Finney. “Many studies originally were looking at late life and are now looking more at earlier in the disease process, and I think that’s important.”

Understanding how sex, ethnicity, and other demographic variables affect risks can help to “tailor interventions” for individual patients, he said.

The study was supported by the National Institutes of Health, the GHR Foundation, and the Rochester Epidemiology Project. Dr. Mielke is a consultant for Biogen and Brain Protection Company and is on the editorial boards of Neurology and Alzheimer’s and Dementia. Dr. Finney has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.