Doctors removed a 4-inch piece of cement from a man’s heart, which had leaked into his body from a spinal surgery, according to a new report published in the New England Journal of Medicine.

The 56-year-old man, who was not identified in the report, went to the emergency room after experiencing 2 days of chest pain and shortness of breath. Imaging scans showed that the chest pain was caused by a foreign object, and he was rushed to surgery.

Surgeons then located and removed a thin, sharp, cylindrical piece of cement and repaired the damage to the patient’s heart. The cement had pierced the upper right chamber of his heart and his right lung, according to the report authors from the Yale University School of Medicine.

A week before, the man had undergone a spinal surgery known as kyphoplasty. The procedure treats spine injuries by injecting a special type of medical cement into damaged vertebrae, according to USA Today. The cement had leaked into the patient’s body, hardened, and traveled to his heart.

The man has now “nearly recovered” since the heart surgery and cement removal, which occurred about a month ago, the journal report stated. He experienced no additional complications.

Cement leakage after kyphoplasty can happen but is an extremely rare complication. Less than 2% of patients who undergo the procedure for osteoporosis or brittle bones have complications, according to patient information from the American Association of Neurological Surgeons.

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

Doctors removed a 4-inch piece of cement from a man’s heart, which had leaked into his body from a spinal surgery, according to a new report published in the New England Journal of Medicine.

The 56-year-old man, who was not identified in the report, went to the emergency room after experiencing 2 days of chest pain and shortness of breath. Imaging scans showed that the chest pain was caused by a foreign object, and he was rushed to surgery.

Surgeons then located and removed a thin, sharp, cylindrical piece of cement and repaired the damage to the patient’s heart. The cement had pierced the upper right chamber of his heart and his right lung, according to the report authors from the Yale University School of Medicine.

A week before, the man had undergone a spinal surgery known as kyphoplasty. The procedure treats spine injuries by injecting a special type of medical cement into damaged vertebrae, according to USA Today. The cement had leaked into the patient’s body, hardened, and traveled to his heart.

The man has now “nearly recovered” since the heart surgery and cement removal, which occurred about a month ago, the journal report stated. He experienced no additional complications.

Cement leakage after kyphoplasty can happen but is an extremely rare complication. Less than 2% of patients who undergo the procedure for osteoporosis or brittle bones have complications, according to patient information from the American Association of Neurological Surgeons.

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

Doctors removed a 4-inch piece of cement from a man’s heart, which had leaked into his body from a spinal surgery, according to a new report published in the New England Journal of Medicine.

The 56-year-old man, who was not identified in the report, went to the emergency room after experiencing 2 days of chest pain and shortness of breath. Imaging scans showed that the chest pain was caused by a foreign object, and he was rushed to surgery.

Surgeons then located and removed a thin, sharp, cylindrical piece of cement and repaired the damage to the patient’s heart. The cement had pierced the upper right chamber of his heart and his right lung, according to the report authors from the Yale University School of Medicine.

A week before, the man had undergone a spinal surgery known as kyphoplasty. The procedure treats spine injuries by injecting a special type of medical cement into damaged vertebrae, according to USA Today. The cement had leaked into the patient’s body, hardened, and traveled to his heart.

The man has now “nearly recovered” since the heart surgery and cement removal, which occurred about a month ago, the journal report stated. He experienced no additional complications.

Cement leakage after kyphoplasty can happen but is an extremely rare complication. Less than 2% of patients who undergo the procedure for osteoporosis or brittle bones have complications, according to patient information from the American Association of Neurological Surgeons.

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

Sixteen-year-old Ana and is sitting on the bench with her science teacher, Ms. Tehrani, waiting for the bus to take them back to their village after school. Ana wants to hear her science teacher’s opinion about her grandmother.

Do you respect your grandmother?

Why yes, of course, why to do you ask?

So you think my grandmother is wise when she tells me old wife tales?

Like what?

Well, she says not to take my medicine because it will have bad effects and that I should take her remedies instead.

What else does she tell you?

Well, she says that people are born how they are and that they belong to either God or the Devil, not to their parents.

What else?

She thinks I am a fay child; she has always said that about me.

What does that mean?

It means that I have my own ways, fairy ways, and that I should go out in the forest and listen.

Do you?

Yes.

What do you hear?

I hear about my destiny.

What do you hear?

I hear that I must wash in witch hazel. My grandmother taught me how to find it and how to prepare it. She said I should sit in the forest and wait for a sign.

What sign?

I don’t know.

Well, what do you think about your grandmother?

I love her but …

But what?

I think she might be wrong about all of this, you know, science and all that.

But you do it, anyway?

Yes.

Why?

Aren’t we supposed to respect our elders, and aren’t they supposed to be wise?



Ms. Tehrani is in a bind. What to say? She has no ready answer, feeling caught between two beliefs: the unscientific basis of ineffective old wives’ treatments and the purported wisdom of our elders. She knows Ana’s family and that there are women in that family going back generations who are identified as medicine women or women with the special powers of the forest.

Ana wants to study science but she is being groomed as the family wise mother. Ana is caught between the ways of the past and the ways of the future. She sees that to go with the future is to devalue her family tradition. If she chooses to study medicine, can she keep the balance between magical ways and the ways of science?

Ms. Tehrani decides to expose her class to Indigenous and preindustrial cultural practices and what science has to say. She describes how knowledge is passed down through the generations, and how some of this knowledge has now been proved correct by science, such as the use of opium for pain management and how some knowledge has been corrected by science. She asks the class: What myths have been passed down in your family that science has shown to be effective or ineffective? What does science have to say about how we live our lives?

After a baby in the village dies, Ms. Tehrani asks the local health center to think about implementing a teaching course on caring for babies, a course that will discuss tradition and science. She is well aware of the fact that Black mothers tend not to follow the advice of the pediatricians who now recommend that parents put babies to sleep on their backs. Black women trust the advice of their paternal and maternal grandmothers more than the advice of health care providers, research by Deborah Stiffler, PhD, RN, CNM, shows (J Spec Pediatr Nurs. 2018 Apr;23[2]:e12213). While new Black mothers feel that they have limited knowledge and are eager to learn about safe sleep practices, their grandmothers were skeptical – and the grandmothers often won that argument. Black mothers believed that their own mothers knew best, based on their experience raising infants.

In Dr. Stiffler’s study, one grandmother commented: “Girls today need a mother to help them take care of their babies. They don’t know how to do anything. When I was growing up, our moms helped us.”

One new mother said: I “listen more to the elderly people because like the social workers and stuff some of them don’t have kids. They just go by the book … so I feel like I listen more to like my grandparents.”
 

Integrating traditions

When Ana enters medical school she is faced with the task of integration of traditional practice and Western medicine. Ana looks to the National Center for Complementary and Integrative Health (NCCIH), the U.S. government’s lead agency for scientific research on complementary and integrative health approaches for support in her task. The NCCIH was established in 1998 with the mission of determining the usefulness and safety of complementary and integrative health approaches, and their roles in improving health and health care.

The NCCIH notes that more than 30% of adults use health care approaches that are not part of conventional medical care or that have origins outside of usual Western practice, and 17.7% of American adults had used a dietary supplement other than vitamins and minerals in the past year, most commonly fish oil. This agency notes that large rigorous research studies extend to only a few dietary supplements, with results showing that the products didn’t work for the conditions studied. The work of the NCCIH is mirrored worldwide.

The 2008 Beijing Declaration called on World Health Organization member states and other stakeholders to integrate traditional medicine and complementary alternative medicines into national health care systems. The WHO Congress on Traditional Medicine recognizes that traditional medicine (TM) may be more affordable and accessible than Western medicine, and that it plays an important role in meeting the demands of primary health care in many developing countries. From 70% to 80% of the population in India and Ethiopia depend on TM for primary health care, and 70% of the population in Canada and 80% in Germany are reported to have used TM as complementary and/or alternative medical treatment.

After graduation and residency, Ana returns to her village and helps her science teacher consider how best to shape the intergenerational transmission of knowledge, so that it is both honored by the elders and also shaped by the science of medicine.

Every village, regardless of where it is in the world, has to contend with finding the balance between the traditional medical knowledge that is passed down through the family and the discoveries of science. When it comes to practicing medicine and psychiatry, a respect for family tradition must be weighed against the application of science: this is a long conversation that is well worth its time.
 

Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). Dr. Heru has no conflicts of interest. Contact Dr. Heru at [email protected].

Sixteen-year-old Ana and is sitting on the bench with her science teacher, Ms. Tehrani, waiting for the bus to take them back to their village after school. Ana wants to hear her science teacher’s opinion about her grandmother.

Do you respect your grandmother?

Why yes, of course, why to do you ask?

So you think my grandmother is wise when she tells me old wife tales?

Like what?

Well, she says not to take my medicine because it will have bad effects and that I should take her remedies instead.

What else does she tell you?

Well, she says that people are born how they are and that they belong to either God or the Devil, not to their parents.

What else?

She thinks I am a fay child; she has always said that about me.

What does that mean?

It means that I have my own ways, fairy ways, and that I should go out in the forest and listen.

Do you?

Yes.

What do you hear?

I hear about my destiny.

What do you hear?

I hear that I must wash in witch hazel. My grandmother taught me how to find it and how to prepare it. She said I should sit in the forest and wait for a sign.

What sign?

I don’t know.

Well, what do you think about your grandmother?

I love her but …

But what?

I think she might be wrong about all of this, you know, science and all that.

But you do it, anyway?

Yes.

Why?

Aren’t we supposed to respect our elders, and aren’t they supposed to be wise?



Ms. Tehrani is in a bind. What to say? She has no ready answer, feeling caught between two beliefs: the unscientific basis of ineffective old wives’ treatments and the purported wisdom of our elders. She knows Ana’s family and that there are women in that family going back generations who are identified as medicine women or women with the special powers of the forest.

Ana wants to study science but she is being groomed as the family wise mother. Ana is caught between the ways of the past and the ways of the future. She sees that to go with the future is to devalue her family tradition. If she chooses to study medicine, can she keep the balance between magical ways and the ways of science?

Ms. Tehrani decides to expose her class to Indigenous and preindustrial cultural practices and what science has to say. She describes how knowledge is passed down through the generations, and how some of this knowledge has now been proved correct by science, such as the use of opium for pain management and how some knowledge has been corrected by science. She asks the class: What myths have been passed down in your family that science has shown to be effective or ineffective? What does science have to say about how we live our lives?

After a baby in the village dies, Ms. Tehrani asks the local health center to think about implementing a teaching course on caring for babies, a course that will discuss tradition and science. She is well aware of the fact that Black mothers tend not to follow the advice of the pediatricians who now recommend that parents put babies to sleep on their backs. Black women trust the advice of their paternal and maternal grandmothers more than the advice of health care providers, research by Deborah Stiffler, PhD, RN, CNM, shows (J Spec Pediatr Nurs. 2018 Apr;23[2]:e12213). While new Black mothers feel that they have limited knowledge and are eager to learn about safe sleep practices, their grandmothers were skeptical – and the grandmothers often won that argument. Black mothers believed that their own mothers knew best, based on their experience raising infants.

In Dr. Stiffler’s study, one grandmother commented: “Girls today need a mother to help them take care of their babies. They don’t know how to do anything. When I was growing up, our moms helped us.”

One new mother said: I “listen more to the elderly people because like the social workers and stuff some of them don’t have kids. They just go by the book … so I feel like I listen more to like my grandparents.”
 

Integrating traditions

When Ana enters medical school she is faced with the task of integration of traditional practice and Western medicine. Ana looks to the National Center for Complementary and Integrative Health (NCCIH), the U.S. government’s lead agency for scientific research on complementary and integrative health approaches for support in her task. The NCCIH was established in 1998 with the mission of determining the usefulness and safety of complementary and integrative health approaches, and their roles in improving health and health care.

The NCCIH notes that more than 30% of adults use health care approaches that are not part of conventional medical care or that have origins outside of usual Western practice, and 17.7% of American adults had used a dietary supplement other than vitamins and minerals in the past year, most commonly fish oil. This agency notes that large rigorous research studies extend to only a few dietary supplements, with results showing that the products didn’t work for the conditions studied. The work of the NCCIH is mirrored worldwide.

The 2008 Beijing Declaration called on World Health Organization member states and other stakeholders to integrate traditional medicine and complementary alternative medicines into national health care systems. The WHO Congress on Traditional Medicine recognizes that traditional medicine (TM) may be more affordable and accessible than Western medicine, and that it plays an important role in meeting the demands of primary health care in many developing countries. From 70% to 80% of the population in India and Ethiopia depend on TM for primary health care, and 70% of the population in Canada and 80% in Germany are reported to have used TM as complementary and/or alternative medical treatment.

After graduation and residency, Ana returns to her village and helps her science teacher consider how best to shape the intergenerational transmission of knowledge, so that it is both honored by the elders and also shaped by the science of medicine.

Every village, regardless of where it is in the world, has to contend with finding the balance between the traditional medical knowledge that is passed down through the family and the discoveries of science. When it comes to practicing medicine and psychiatry, a respect for family tradition must be weighed against the application of science: this is a long conversation that is well worth its time.
 

Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). Dr. Heru has no conflicts of interest. Contact Dr. Heru at [email protected].

Sixteen-year-old Ana and is sitting on the bench with her science teacher, Ms. Tehrani, waiting for the bus to take them back to their village after school. Ana wants to hear her science teacher’s opinion about her grandmother.

Do you respect your grandmother?

Why yes, of course, why to do you ask?

So you think my grandmother is wise when she tells me old wife tales?

Like what?

Well, she says not to take my medicine because it will have bad effects and that I should take her remedies instead.

What else does she tell you?

Well, she says that people are born how they are and that they belong to either God or the Devil, not to their parents.

What else?

She thinks I am a fay child; she has always said that about me.

What does that mean?

It means that I have my own ways, fairy ways, and that I should go out in the forest and listen.

Do you?

Yes.

What do you hear?

I hear about my destiny.

What do you hear?

I hear that I must wash in witch hazel. My grandmother taught me how to find it and how to prepare it. She said I should sit in the forest and wait for a sign.

What sign?

I don’t know.

Well, what do you think about your grandmother?

I love her but …

But what?

I think she might be wrong about all of this, you know, science and all that.

But you do it, anyway?

Yes.

Why?

Aren’t we supposed to respect our elders, and aren’t they supposed to be wise?



Ms. Tehrani is in a bind. What to say? She has no ready answer, feeling caught between two beliefs: the unscientific basis of ineffective old wives’ treatments and the purported wisdom of our elders. She knows Ana’s family and that there are women in that family going back generations who are identified as medicine women or women with the special powers of the forest.

Ana wants to study science but she is being groomed as the family wise mother. Ana is caught between the ways of the past and the ways of the future. She sees that to go with the future is to devalue her family tradition. If she chooses to study medicine, can she keep the balance between magical ways and the ways of science?

Ms. Tehrani decides to expose her class to Indigenous and preindustrial cultural practices and what science has to say. She describes how knowledge is passed down through the generations, and how some of this knowledge has now been proved correct by science, such as the use of opium for pain management and how some knowledge has been corrected by science. She asks the class: What myths have been passed down in your family that science has shown to be effective or ineffective? What does science have to say about how we live our lives?

After a baby in the village dies, Ms. Tehrani asks the local health center to think about implementing a teaching course on caring for babies, a course that will discuss tradition and science. She is well aware of the fact that Black mothers tend not to follow the advice of the pediatricians who now recommend that parents put babies to sleep on their backs. Black women trust the advice of their paternal and maternal grandmothers more than the advice of health care providers, research by Deborah Stiffler, PhD, RN, CNM, shows (J Spec Pediatr Nurs. 2018 Apr;23[2]:e12213). While new Black mothers feel that they have limited knowledge and are eager to learn about safe sleep practices, their grandmothers were skeptical – and the grandmothers often won that argument. Black mothers believed that their own mothers knew best, based on their experience raising infants.

In Dr. Stiffler’s study, one grandmother commented: “Girls today need a mother to help them take care of their babies. They don’t know how to do anything. When I was growing up, our moms helped us.”

One new mother said: I “listen more to the elderly people because like the social workers and stuff some of them don’t have kids. They just go by the book … so I feel like I listen more to like my grandparents.”
 

Integrating traditions

When Ana enters medical school she is faced with the task of integration of traditional practice and Western medicine. Ana looks to the National Center for Complementary and Integrative Health (NCCIH), the U.S. government’s lead agency for scientific research on complementary and integrative health approaches for support in her task. The NCCIH was established in 1998 with the mission of determining the usefulness and safety of complementary and integrative health approaches, and their roles in improving health and health care.

The NCCIH notes that more than 30% of adults use health care approaches that are not part of conventional medical care or that have origins outside of usual Western practice, and 17.7% of American adults had used a dietary supplement other than vitamins and minerals in the past year, most commonly fish oil. This agency notes that large rigorous research studies extend to only a few dietary supplements, with results showing that the products didn’t work for the conditions studied. The work of the NCCIH is mirrored worldwide.

The 2008 Beijing Declaration called on World Health Organization member states and other stakeholders to integrate traditional medicine and complementary alternative medicines into national health care systems. The WHO Congress on Traditional Medicine recognizes that traditional medicine (TM) may be more affordable and accessible than Western medicine, and that it plays an important role in meeting the demands of primary health care in many developing countries. From 70% to 80% of the population in India and Ethiopia depend on TM for primary health care, and 70% of the population in Canada and 80% in Germany are reported to have used TM as complementary and/or alternative medical treatment.

After graduation and residency, Ana returns to her village and helps her science teacher consider how best to shape the intergenerational transmission of knowledge, so that it is both honored by the elders and also shaped by the science of medicine.

Every village, regardless of where it is in the world, has to contend with finding the balance between the traditional medical knowledge that is passed down through the family and the discoveries of science. When it comes to practicing medicine and psychiatry, a respect for family tradition must be weighed against the application of science: this is a long conversation that is well worth its time.
 

Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). Dr. Heru has no conflicts of interest. Contact Dr. Heru at [email protected].

A federal judge has paused the recent Texas abortion law that bans nearly all abortions in the state.

Robert Pitman, a federal district court judge in Austin, sided with the Biden administration and granted the Justice Department’s request to halt enforcement of the new law. The Biden administration sued to stop the law, and Mr. Pitman’s decision pauses the law while it moves through federal courts, The New York Times reported.

In a 113-page ruling, Mr. Pitman criticized the law, also known as Senate Bill 8, for delegating enforcement to private individuals, who can sue anyone who performs abortions or “aids and abets” them. Plaintiffs are encouraged to file lawsuits because they recover legal fees and $10,000 if they win.

“From the moment S.B. 8 went into effect, women have been unlawfully prevented from exercising control over their own lives in ways that are protected by the Constitution,” Mr. Pitman wrote in the ruling.

“This court will not sanction one more day of this offensive deprivation of such an important right,” he said.

The Texas law bans abortions once fetal cardiac activity can be detected, which is usually around 6 weeks of pregnancy. Women may not know they’re pregnant yet during that time frame.

It’s not yet clear what effect Mr. Pitman’s ruling will have on women in Texas, the Times reported. Since the law went into effect about a month ago, women have sought abortion providers in other states. Mr. Pitman’s ruling pauses the enforcement of the law, but clinics may still face retroactive lawsuits for abortions provided while the law was temporarily suspended.

Whole Woman’s Health, which operates four clinics in Texas, said Wednesday that it was “making plans to resume abortion care up to 18 weeks as soon as possible,” the newspaper reported. The Center for Reproductive Rights also said that clinics “hope to resume full abortion services as soon as they are able.”

Late Oct. 6, Texas said it would appeal the ruling. The U.S. Court of Appeals for the Fifth Circuit is one of the most conservative in the country, according to the Times, and another decision could come soon.

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

A federal judge has paused the recent Texas abortion law that bans nearly all abortions in the state.

Robert Pitman, a federal district court judge in Austin, sided with the Biden administration and granted the Justice Department’s request to halt enforcement of the new law. The Biden administration sued to stop the law, and Mr. Pitman’s decision pauses the law while it moves through federal courts, The New York Times reported.

In a 113-page ruling, Mr. Pitman criticized the law, also known as Senate Bill 8, for delegating enforcement to private individuals, who can sue anyone who performs abortions or “aids and abets” them. Plaintiffs are encouraged to file lawsuits because they recover legal fees and $10,000 if they win.

“From the moment S.B. 8 went into effect, women have been unlawfully prevented from exercising control over their own lives in ways that are protected by the Constitution,” Mr. Pitman wrote in the ruling.

“This court will not sanction one more day of this offensive deprivation of such an important right,” he said.

The Texas law bans abortions once fetal cardiac activity can be detected, which is usually around 6 weeks of pregnancy. Women may not know they’re pregnant yet during that time frame.

It’s not yet clear what effect Mr. Pitman’s ruling will have on women in Texas, the Times reported. Since the law went into effect about a month ago, women have sought abortion providers in other states. Mr. Pitman’s ruling pauses the enforcement of the law, but clinics may still face retroactive lawsuits for abortions provided while the law was temporarily suspended.

Whole Woman’s Health, which operates four clinics in Texas, said Wednesday that it was “making plans to resume abortion care up to 18 weeks as soon as possible,” the newspaper reported. The Center for Reproductive Rights also said that clinics “hope to resume full abortion services as soon as they are able.”

Late Oct. 6, Texas said it would appeal the ruling. The U.S. Court of Appeals for the Fifth Circuit is one of the most conservative in the country, according to the Times, and another decision could come soon.

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

A federal judge has paused the recent Texas abortion law that bans nearly all abortions in the state.

Robert Pitman, a federal district court judge in Austin, sided with the Biden administration and granted the Justice Department’s request to halt enforcement of the new law. The Biden administration sued to stop the law, and Mr. Pitman’s decision pauses the law while it moves through federal courts, The New York Times reported.

In a 113-page ruling, Mr. Pitman criticized the law, also known as Senate Bill 8, for delegating enforcement to private individuals, who can sue anyone who performs abortions or “aids and abets” them. Plaintiffs are encouraged to file lawsuits because they recover legal fees and $10,000 if they win.

“From the moment S.B. 8 went into effect, women have been unlawfully prevented from exercising control over their own lives in ways that are protected by the Constitution,” Mr. Pitman wrote in the ruling.

“This court will not sanction one more day of this offensive deprivation of such an important right,” he said.

The Texas law bans abortions once fetal cardiac activity can be detected, which is usually around 6 weeks of pregnancy. Women may not know they’re pregnant yet during that time frame.

It’s not yet clear what effect Mr. Pitman’s ruling will have on women in Texas, the Times reported. Since the law went into effect about a month ago, women have sought abortion providers in other states. Mr. Pitman’s ruling pauses the enforcement of the law, but clinics may still face retroactive lawsuits for abortions provided while the law was temporarily suspended.

Whole Woman’s Health, which operates four clinics in Texas, said Wednesday that it was “making plans to resume abortion care up to 18 weeks as soon as possible,” the newspaper reported. The Center for Reproductive Rights also said that clinics “hope to resume full abortion services as soon as they are able.”

Late Oct. 6, Texas said it would appeal the ruling. The U.S. Court of Appeals for the Fifth Circuit is one of the most conservative in the country, according to the Times, and another decision could come soon.

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

Vikram Bhise, MD, Is an Associate Professor at Rutgers – Robert Wood Johnson Medical School.  He specializes in Epilepsy and Pediatric Neuroimmunology, and runs the pediatric demyelinating diseases program, evaluating children with multiple sclerosis, autoimmune encephalopathy, and related diseases.  He trained in Pediatrics and Pediatric Neurology, at Maimonides Medical Center and Montefiore Medical Center, respectively.  He subsequently received additional training in Clinical Neurophysiology with a focus on Epilepsy at SUNY Downstate Medical Center, and in Pediatric Multiple Sclerosis at SUNY Stony Brook Medical Center. Dr. Bhise conducts clinical research focused on biomarkers and quality of life in pediatric multiple sclerosis, as well as studies in epilepsy and neurogenetics. 

Q1. As a specialist who focuses on neuroimmunology, what forms of measurement do you use to make an evaluation or diagnosis for children with multiple sclerosis?

A1. There's a lot that goes into evaluating or diagnosing children with MS. Usually we start off with the story that the family brings to us. We look at what the child is experiencing and what the parents are seeing. Then we do a dedicated examination trying to substantiate the findings that they're describing and look for others they may not even be aware of. If they are having some blurred vision in their eye, can we tell if there's some abnormalities there that are correlating with what they see?

We try to get a good sense of the time-course of things, observing whether this is the first time something's happened or if this has this been going on for a while. Have there been multiple things going on, multiple episodes? We're primarily looking for events called relapses, which are neurologic attacks that are not quick. They don’t last for seconds or hours; they can last for days to weeks, sometimes even months. Individuals will have episodes that tend to get worse and then tend to get better. This is the type of description we’re looking to come from the families.

Once that assessment is complete, we've found that the MRI is one of the best tools in helping us confirm the diagnosis. It's not just diagnostic but the MRI also  has some prognostic potential and we're looking specifically for patterns in the MRIs. For children, that pattern can be a little bit more challenging. Their patterns can often overlap with patterns of other inflammatory diseases of the brain like ADEM for example and make it much more difficult for us to characterize someone as truly having MS.

There are also some other diseases which have been discovered in the past decade or elaborated upon like neuromyelitis optica and MOG antibody disorder, which can look exactly like MS in the early stages. Sometimes,  that's just not all the information we need. Sometimes it's more difficult to make those distinctions and in these cases, we will look at a spinal tap, a lumbar puncture, and for specific studies from those procedures to help us get a better understanding. There may be other ancillary tests that we use, such as evoked potentials, for example.

Evoked potential testing has kind of fallen to the wayside over the past decade because of the MRI studies becoming a much more useful tool, but we may still use the visual evoked potential to see if there are subtle lesions that can't be seen on the MRI. Other methods might include optical coherence tomography, which is another test looking at the eye that gives you a specific look at the retinal nerve fiber layer, which gets thinned after attacks on the eye on the optic nerve.

We may do neuropsychological testing, which is a battery of tests looking at different cognitive domains and trying to get a sense of a person's cognitive profile to see if that matches what we would expect in somebody with MS. This test could be more challenging for a teen and a child, particularly a younger child. When it comes to pediatric neuropsychology, it's a little bit harder sometimes to get good data, particularly from younger kids.

In addition, we have a battery of tests that we do on the serum. Some disorders, like NMO and MOG, have antibodies that help us identify them. We don't have a specific test that says, yes, you have MS and no, you don't have MS. It's really the combination of all the tools.

We do these tests often to look for things that mimic MS. We look for other neuroinflammatory or neurobiological diseases that can look a lot like MS and fool us. Most of the time they don't look exactly like MS, but every now and then you get a case that's virtually indistinguishable. There are other tools which may be in less use, but we put the combination of all these things together to help us make the most informed judgment.

The goal is to be able to have honest discussions with families that these tools are just tools that we're trying to play catch up with a disease and try to make a decision as fast as possible to prevent someone from going untreated.

Q2.  How does a diagnosis of multiple sclerosis affect the overall quality of life for a child/teen, and how does it affect their overall psychosocial health? Education?  Transition needs? Etc.

A2. It can be quite profound, just hearing the diagnosis can be truly life changing for most folks. It would really depend on the family the first time that we meet them. If they have no suspicion that this is what's going on, that can be a shock. Other families may be more aware of what’s going on. Perhaps another physician has already suggested it, or they came from the ER which had already done some of the baseline tests like the MRI, and they had some kind of  suspicion. Maybe they googled it and they saw something to be worried about, so they may be prepared. But even then,  once you confirm the diagnosis, it's really like the sky falling at that point.

Past the diagnosis stage, there's really an adjustment phase that we see, and we've been doing some work in this. We started doing some work looking at quality of life. We've interviewed a large  number of families and asked them some key questions such as, “What's important to you?” It is key for them to tell us rather than us telling them. By doing this, we’re finding out things that may not have been on the forefront of our minds, although it was certainly in the forefront of their minds,  so it's a good learning opportunity.

These may be things that we've seen in other quality of life studies in other diseases, but you also have to consider each disease unique and make sure you're looking at this from the perspective of the people that are really being affected. One of the great examples was that the teens really cared more about visible symptoms. For example, an adult with MS may have fatigue, severe fatigue. They may be unable to perform well in their job and that could be a game changer for them. Yet if they had a mild limp, they'd say, yeah, it's kind of embarrassing but I can keep going forward. I can hang in there and my colleagues at work might even support me; but for a teenager, they may care less about the fatigue and way more about having this limp that all their peers can now notice. The symptoms that are important to them can be totally different depending on the age group.

What we found is that teenagers look at things quite differently in trying to optimize their outcomes, and we don't just want them to be medically well. We want them to succeed in school, we want them to succeed in getting into college, or going into the workforce. So, we asked a lot about what it takes to get you there. We asked a lot of the young adults who had pediatric onset MS if they were  successful? And if you were, what got you there; and the ones who hadn't reached that yet we asked-- what do you need?

When it came to transition needs, by far, we’ve found almost complete silence on the teenager’s part, which was a little surprising for us. We thought that there would be a little bit of discussion. They didn’t understand what a 504 is. We don't expect the average individual to know, but we thought that they might understand what the tools were, yet they really had no language for discussing that with us. We realized that the start of our transition talks had to be focused on the things that we use for that language.

For example, if I wanted to get a ding in my car fixed. I had to spend 20 minutes explaining to the dealership what I wanted. It was a regular car dealership, so it was integrated. But I had to find the right words to say. I want “auto body.” If I said vehicle repair, they said, oh, you want your car tires replaced? No, no, no. so, it’s very important to speak the right language just to get the process started. Those are some of the things that we found.

Q3. In what ways do environmental and genetic risk factors influence therapeutic decisions in pediatric patients with MS? 

A3. They really play a big role in terms of the risk. We find that the more risk factors you have, likely we're dealing with a more severe disease. It doesn't necessarily always work that way, but you may be prepared to use a more potent therapy for individuals that are hitting more of the categories of concern.

But in addition to just the main disease modifying medications and MS, we look at vitamin D. And the data is yet to come out on that. There are some big studies that are trying to confirm or refute if vitamin D really has a therapeutic role, but we find that our teens and our kids have lower than average low vitamin D levels. We know that kids have low vitamin D levels nationwide in this country, but our patients are even lower than that. And that's one thing that we try to supplement and hope that by supplementing it, that it's going to be helpful. Maybe it's not as potent to therapy as the main medications, but we're hoping that's something to add on.

Q4. Overall, what are some advances, trends or recent studies regarding therapies that might support positive outcomes in children with MS? 

A4  Interestingly, we just don't have a lot of that research in kids. There's been tons and tons of great research in adults. Like many other fields, you take what you learn from that and you apply it to the teens and kids. But we've learned time and time again they're not just little adults. They're truly a separate group, and we must consider them as such, and we really need those studies in kids.

The first study that came out confirmed that fingolimod was a good and effective therapy in children. But does that mean that you're only limited to using the only FDA approved option, or do you really want to try to offer families the litany of choices that you do for an adult with MS? When I meet families for the first time, we’re spending a good hour just talking about the different treatment choices with them and looking at the risks, the benefits, why one option might be chosen over another,  how it's going to affect their lifestyle, and how it might fit into their life.

We want to still be able to make those decisions. I think we can make a more informed decision with fingolimod, but we don't want to just jump to conclusions with all those other therapies. We're a little bit behind the mark when it comes to therapies with kids, and we really need all those studies. They are active, and they are being done now; we're really waiting for those results to come out. That's going to be a huge change. Basically, that's the real trend. We're now going to see those studies in adults being replicated in kids one by one. Every time a new therapy comes out for adults, it must be validated in children as well.

Part of the regulations now do stipulate that these studies must be done. If you do a study in the adult population, you must see if you can do it in the pediatric population. You can't just say, hey, you know we're done. That's really what we're looking for in terms of getting the big therapeutic outcomes.

Vikram Bhise, MD, Is an Associate Professor at Rutgers – Robert Wood Johnson Medical School.  He specializes in Epilepsy and Pediatric Neuroimmunology, and runs the pediatric demyelinating diseases program, evaluating children with multiple sclerosis, autoimmune encephalopathy, and related diseases.  He trained in Pediatrics and Pediatric Neurology, at Maimonides Medical Center and Montefiore Medical Center, respectively.  He subsequently received additional training in Clinical Neurophysiology with a focus on Epilepsy at SUNY Downstate Medical Center, and in Pediatric Multiple Sclerosis at SUNY Stony Brook Medical Center. Dr. Bhise conducts clinical research focused on biomarkers and quality of life in pediatric multiple sclerosis, as well as studies in epilepsy and neurogenetics. 

Q1. As a specialist who focuses on neuroimmunology, what forms of measurement do you use to make an evaluation or diagnosis for children with multiple sclerosis?

A1. There's a lot that goes into evaluating or diagnosing children with MS. Usually we start off with the story that the family brings to us. We look at what the child is experiencing and what the parents are seeing. Then we do a dedicated examination trying to substantiate the findings that they're describing and look for others they may not even be aware of. If they are having some blurred vision in their eye, can we tell if there's some abnormalities there that are correlating with what they see?

We try to get a good sense of the time-course of things, observing whether this is the first time something's happened or if this has this been going on for a while. Have there been multiple things going on, multiple episodes? We're primarily looking for events called relapses, which are neurologic attacks that are not quick. They don’t last for seconds or hours; they can last for days to weeks, sometimes even months. Individuals will have episodes that tend to get worse and then tend to get better. This is the type of description we’re looking to come from the families.

Once that assessment is complete, we've found that the MRI is one of the best tools in helping us confirm the diagnosis. It's not just diagnostic but the MRI also  has some prognostic potential and we're looking specifically for patterns in the MRIs. For children, that pattern can be a little bit more challenging. Their patterns can often overlap with patterns of other inflammatory diseases of the brain like ADEM for example and make it much more difficult for us to characterize someone as truly having MS.

There are also some other diseases which have been discovered in the past decade or elaborated upon like neuromyelitis optica and MOG antibody disorder, which can look exactly like MS in the early stages. Sometimes,  that's just not all the information we need. Sometimes it's more difficult to make those distinctions and in these cases, we will look at a spinal tap, a lumbar puncture, and for specific studies from those procedures to help us get a better understanding. There may be other ancillary tests that we use, such as evoked potentials, for example.

Evoked potential testing has kind of fallen to the wayside over the past decade because of the MRI studies becoming a much more useful tool, but we may still use the visual evoked potential to see if there are subtle lesions that can't be seen on the MRI. Other methods might include optical coherence tomography, which is another test looking at the eye that gives you a specific look at the retinal nerve fiber layer, which gets thinned after attacks on the eye on the optic nerve.

We may do neuropsychological testing, which is a battery of tests looking at different cognitive domains and trying to get a sense of a person's cognitive profile to see if that matches what we would expect in somebody with MS. This test could be more challenging for a teen and a child, particularly a younger child. When it comes to pediatric neuropsychology, it's a little bit harder sometimes to get good data, particularly from younger kids.

In addition, we have a battery of tests that we do on the serum. Some disorders, like NMO and MOG, have antibodies that help us identify them. We don't have a specific test that says, yes, you have MS and no, you don't have MS. It's really the combination of all the tools.

We do these tests often to look for things that mimic MS. We look for other neuroinflammatory or neurobiological diseases that can look a lot like MS and fool us. Most of the time they don't look exactly like MS, but every now and then you get a case that's virtually indistinguishable. There are other tools which may be in less use, but we put the combination of all these things together to help us make the most informed judgment.

The goal is to be able to have honest discussions with families that these tools are just tools that we're trying to play catch up with a disease and try to make a decision as fast as possible to prevent someone from going untreated.

Q2.  How does a diagnosis of multiple sclerosis affect the overall quality of life for a child/teen, and how does it affect their overall psychosocial health? Education?  Transition needs? Etc.

A2. It can be quite profound, just hearing the diagnosis can be truly life changing for most folks. It would really depend on the family the first time that we meet them. If they have no suspicion that this is what's going on, that can be a shock. Other families may be more aware of what’s going on. Perhaps another physician has already suggested it, or they came from the ER which had already done some of the baseline tests like the MRI, and they had some kind of  suspicion. Maybe they googled it and they saw something to be worried about, so they may be prepared. But even then,  once you confirm the diagnosis, it's really like the sky falling at that point.

Past the diagnosis stage, there's really an adjustment phase that we see, and we've been doing some work in this. We started doing some work looking at quality of life. We've interviewed a large  number of families and asked them some key questions such as, “What's important to you?” It is key for them to tell us rather than us telling them. By doing this, we’re finding out things that may not have been on the forefront of our minds, although it was certainly in the forefront of their minds,  so it's a good learning opportunity.

These may be things that we've seen in other quality of life studies in other diseases, but you also have to consider each disease unique and make sure you're looking at this from the perspective of the people that are really being affected. One of the great examples was that the teens really cared more about visible symptoms. For example, an adult with MS may have fatigue, severe fatigue. They may be unable to perform well in their job and that could be a game changer for them. Yet if they had a mild limp, they'd say, yeah, it's kind of embarrassing but I can keep going forward. I can hang in there and my colleagues at work might even support me; but for a teenager, they may care less about the fatigue and way more about having this limp that all their peers can now notice. The symptoms that are important to them can be totally different depending on the age group.

What we found is that teenagers look at things quite differently in trying to optimize their outcomes, and we don't just want them to be medically well. We want them to succeed in school, we want them to succeed in getting into college, or going into the workforce. So, we asked a lot about what it takes to get you there. We asked a lot of the young adults who had pediatric onset MS if they were  successful? And if you were, what got you there; and the ones who hadn't reached that yet we asked-- what do you need?

When it came to transition needs, by far, we’ve found almost complete silence on the teenager’s part, which was a little surprising for us. We thought that there would be a little bit of discussion. They didn’t understand what a 504 is. We don't expect the average individual to know, but we thought that they might understand what the tools were, yet they really had no language for discussing that with us. We realized that the start of our transition talks had to be focused on the things that we use for that language.

For example, if I wanted to get a ding in my car fixed. I had to spend 20 minutes explaining to the dealership what I wanted. It was a regular car dealership, so it was integrated. But I had to find the right words to say. I want “auto body.” If I said vehicle repair, they said, oh, you want your car tires replaced? No, no, no. so, it’s very important to speak the right language just to get the process started. Those are some of the things that we found.

Q3. In what ways do environmental and genetic risk factors influence therapeutic decisions in pediatric patients with MS? 

A3. They really play a big role in terms of the risk. We find that the more risk factors you have, likely we're dealing with a more severe disease. It doesn't necessarily always work that way, but you may be prepared to use a more potent therapy for individuals that are hitting more of the categories of concern.

But in addition to just the main disease modifying medications and MS, we look at vitamin D. And the data is yet to come out on that. There are some big studies that are trying to confirm or refute if vitamin D really has a therapeutic role, but we find that our teens and our kids have lower than average low vitamin D levels. We know that kids have low vitamin D levels nationwide in this country, but our patients are even lower than that. And that's one thing that we try to supplement and hope that by supplementing it, that it's going to be helpful. Maybe it's not as potent to therapy as the main medications, but we're hoping that's something to add on.

Q4. Overall, what are some advances, trends or recent studies regarding therapies that might support positive outcomes in children with MS? 

A4  Interestingly, we just don't have a lot of that research in kids. There's been tons and tons of great research in adults. Like many other fields, you take what you learn from that and you apply it to the teens and kids. But we've learned time and time again they're not just little adults. They're truly a separate group, and we must consider them as such, and we really need those studies in kids.

The first study that came out confirmed that fingolimod was a good and effective therapy in children. But does that mean that you're only limited to using the only FDA approved option, or do you really want to try to offer families the litany of choices that you do for an adult with MS? When I meet families for the first time, we’re spending a good hour just talking about the different treatment choices with them and looking at the risks, the benefits, why one option might be chosen over another,  how it's going to affect their lifestyle, and how it might fit into their life.

We want to still be able to make those decisions. I think we can make a more informed decision with fingolimod, but we don't want to just jump to conclusions with all those other therapies. We're a little bit behind the mark when it comes to therapies with kids, and we really need all those studies. They are active, and they are being done now; we're really waiting for those results to come out. That's going to be a huge change. Basically, that's the real trend. We're now going to see those studies in adults being replicated in kids one by one. Every time a new therapy comes out for adults, it must be validated in children as well.

Part of the regulations now do stipulate that these studies must be done. If you do a study in the adult population, you must see if you can do it in the pediatric population. You can't just say, hey, you know we're done. That's really what we're looking for in terms of getting the big therapeutic outcomes.

Vikram Bhise, MD, Is an Associate Professor at Rutgers – Robert Wood Johnson Medical School.  He specializes in Epilepsy and Pediatric Neuroimmunology, and runs the pediatric demyelinating diseases program, evaluating children with multiple sclerosis, autoimmune encephalopathy, and related diseases.  He trained in Pediatrics and Pediatric Neurology, at Maimonides Medical Center and Montefiore Medical Center, respectively.  He subsequently received additional training in Clinical Neurophysiology with a focus on Epilepsy at SUNY Downstate Medical Center, and in Pediatric Multiple Sclerosis at SUNY Stony Brook Medical Center. Dr. Bhise conducts clinical research focused on biomarkers and quality of life in pediatric multiple sclerosis, as well as studies in epilepsy and neurogenetics. 

Q1. As a specialist who focuses on neuroimmunology, what forms of measurement do you use to make an evaluation or diagnosis for children with multiple sclerosis?

A1. There's a lot that goes into evaluating or diagnosing children with MS. Usually we start off with the story that the family brings to us. We look at what the child is experiencing and what the parents are seeing. Then we do a dedicated examination trying to substantiate the findings that they're describing and look for others they may not even be aware of. If they are having some blurred vision in their eye, can we tell if there's some abnormalities there that are correlating with what they see?

We try to get a good sense of the time-course of things, observing whether this is the first time something's happened or if this has this been going on for a while. Have there been multiple things going on, multiple episodes? We're primarily looking for events called relapses, which are neurologic attacks that are not quick. They don’t last for seconds or hours; they can last for days to weeks, sometimes even months. Individuals will have episodes that tend to get worse and then tend to get better. This is the type of description we’re looking to come from the families.

Once that assessment is complete, we've found that the MRI is one of the best tools in helping us confirm the diagnosis. It's not just diagnostic but the MRI also  has some prognostic potential and we're looking specifically for patterns in the MRIs. For children, that pattern can be a little bit more challenging. Their patterns can often overlap with patterns of other inflammatory diseases of the brain like ADEM for example and make it much more difficult for us to characterize someone as truly having MS.

There are also some other diseases which have been discovered in the past decade or elaborated upon like neuromyelitis optica and MOG antibody disorder, which can look exactly like MS in the early stages. Sometimes,  that's just not all the information we need. Sometimes it's more difficult to make those distinctions and in these cases, we will look at a spinal tap, a lumbar puncture, and for specific studies from those procedures to help us get a better understanding. There may be other ancillary tests that we use, such as evoked potentials, for example.

Evoked potential testing has kind of fallen to the wayside over the past decade because of the MRI studies becoming a much more useful tool, but we may still use the visual evoked potential to see if there are subtle lesions that can't be seen on the MRI. Other methods might include optical coherence tomography, which is another test looking at the eye that gives you a specific look at the retinal nerve fiber layer, which gets thinned after attacks on the eye on the optic nerve.

We may do neuropsychological testing, which is a battery of tests looking at different cognitive domains and trying to get a sense of a person's cognitive profile to see if that matches what we would expect in somebody with MS. This test could be more challenging for a teen and a child, particularly a younger child. When it comes to pediatric neuropsychology, it's a little bit harder sometimes to get good data, particularly from younger kids.

In addition, we have a battery of tests that we do on the serum. Some disorders, like NMO and MOG, have antibodies that help us identify them. We don't have a specific test that says, yes, you have MS and no, you don't have MS. It's really the combination of all the tools.

We do these tests often to look for things that mimic MS. We look for other neuroinflammatory or neurobiological diseases that can look a lot like MS and fool us. Most of the time they don't look exactly like MS, but every now and then you get a case that's virtually indistinguishable. There are other tools which may be in less use, but we put the combination of all these things together to help us make the most informed judgment.

The goal is to be able to have honest discussions with families that these tools are just tools that we're trying to play catch up with a disease and try to make a decision as fast as possible to prevent someone from going untreated.

Q2.  How does a diagnosis of multiple sclerosis affect the overall quality of life for a child/teen, and how does it affect their overall psychosocial health? Education?  Transition needs? Etc.

A2. It can be quite profound, just hearing the diagnosis can be truly life changing for most folks. It would really depend on the family the first time that we meet them. If they have no suspicion that this is what's going on, that can be a shock. Other families may be more aware of what’s going on. Perhaps another physician has already suggested it, or they came from the ER which had already done some of the baseline tests like the MRI, and they had some kind of  suspicion. Maybe they googled it and they saw something to be worried about, so they may be prepared. But even then,  once you confirm the diagnosis, it's really like the sky falling at that point.

Past the diagnosis stage, there's really an adjustment phase that we see, and we've been doing some work in this. We started doing some work looking at quality of life. We've interviewed a large  number of families and asked them some key questions such as, “What's important to you?” It is key for them to tell us rather than us telling them. By doing this, we’re finding out things that may not have been on the forefront of our minds, although it was certainly in the forefront of their minds,  so it's a good learning opportunity.

These may be things that we've seen in other quality of life studies in other diseases, but you also have to consider each disease unique and make sure you're looking at this from the perspective of the people that are really being affected. One of the great examples was that the teens really cared more about visible symptoms. For example, an adult with MS may have fatigue, severe fatigue. They may be unable to perform well in their job and that could be a game changer for them. Yet if they had a mild limp, they'd say, yeah, it's kind of embarrassing but I can keep going forward. I can hang in there and my colleagues at work might even support me; but for a teenager, they may care less about the fatigue and way more about having this limp that all their peers can now notice. The symptoms that are important to them can be totally different depending on the age group.

What we found is that teenagers look at things quite differently in trying to optimize their outcomes, and we don't just want them to be medically well. We want them to succeed in school, we want them to succeed in getting into college, or going into the workforce. So, we asked a lot about what it takes to get you there. We asked a lot of the young adults who had pediatric onset MS if they were  successful? And if you were, what got you there; and the ones who hadn't reached that yet we asked-- what do you need?

When it came to transition needs, by far, we’ve found almost complete silence on the teenager’s part, which was a little surprising for us. We thought that there would be a little bit of discussion. They didn’t understand what a 504 is. We don't expect the average individual to know, but we thought that they might understand what the tools were, yet they really had no language for discussing that with us. We realized that the start of our transition talks had to be focused on the things that we use for that language.

For example, if I wanted to get a ding in my car fixed. I had to spend 20 minutes explaining to the dealership what I wanted. It was a regular car dealership, so it was integrated. But I had to find the right words to say. I want “auto body.” If I said vehicle repair, they said, oh, you want your car tires replaced? No, no, no. so, it’s very important to speak the right language just to get the process started. Those are some of the things that we found.

Q3. In what ways do environmental and genetic risk factors influence therapeutic decisions in pediatric patients with MS? 

A3. They really play a big role in terms of the risk. We find that the more risk factors you have, likely we're dealing with a more severe disease. It doesn't necessarily always work that way, but you may be prepared to use a more potent therapy for individuals that are hitting more of the categories of concern.

But in addition to just the main disease modifying medications and MS, we look at vitamin D. And the data is yet to come out on that. There are some big studies that are trying to confirm or refute if vitamin D really has a therapeutic role, but we find that our teens and our kids have lower than average low vitamin D levels. We know that kids have low vitamin D levels nationwide in this country, but our patients are even lower than that. And that's one thing that we try to supplement and hope that by supplementing it, that it's going to be helpful. Maybe it's not as potent to therapy as the main medications, but we're hoping that's something to add on.

Q4. Overall, what are some advances, trends or recent studies regarding therapies that might support positive outcomes in children with MS? 

A4  Interestingly, we just don't have a lot of that research in kids. There's been tons and tons of great research in adults. Like many other fields, you take what you learn from that and you apply it to the teens and kids. But we've learned time and time again they're not just little adults. They're truly a separate group, and we must consider them as such, and we really need those studies in kids.

The first study that came out confirmed that fingolimod was a good and effective therapy in children. But does that mean that you're only limited to using the only FDA approved option, or do you really want to try to offer families the litany of choices that you do for an adult with MS? When I meet families for the first time, we’re spending a good hour just talking about the different treatment choices with them and looking at the risks, the benefits, why one option might be chosen over another,  how it's going to affect their lifestyle, and how it might fit into their life.

We want to still be able to make those decisions. I think we can make a more informed decision with fingolimod, but we don't want to just jump to conclusions with all those other therapies. We're a little bit behind the mark when it comes to therapies with kids, and we really need all those studies. They are active, and they are being done now; we're really waiting for those results to come out. That's going to be a huge change. Basically, that's the real trend. We're now going to see those studies in adults being replicated in kids one by one. Every time a new therapy comes out for adults, it must be validated in children as well.

Part of the regulations now do stipulate that these studies must be done. If you do a study in the adult population, you must see if you can do it in the pediatric population. You can't just say, hey, you know we're done. That's really what we're looking for in terms of getting the big therapeutic outcomes.

Jessie Wrobel is a board-certified Family Nurse Practitioner. She earned a Bachelor of Science in Nursing from Southern Connecticut State University, concurrently graduating from their Honor’s College in 2009 and spent 9 years at the bedside focusing on heart failure and stroke populations. She then obtained a Master of Science in Nursing from Southern Connecticut State University and holds a certification with the American Academy of Nurse Practitioners (AANP) as a family nurse practitioner. She has since worked at Yale-New Haven’s Sleep Medicine Center where she follows patients for sleep disordered breathing, narcolepsy, parasomnias, restless leg syndrome and insomnia.

Jessie Wrobel is a board-certified Family Nurse Practitioner. She earned a Bachelor of Science in Nursing from Southern Connecticut State University, concurrently graduating from their Honor’s College in 2009 and spent 9 years at the bedside focusing on heart failure and stroke populations. She then obtained a Master of Science in Nursing from Southern Connecticut State University and holds a certification with the American Academy of Nurse Practitioners (AANP) as a family nurse practitioner. She has since worked at Yale-New Haven’s Sleep Medicine Center where she follows patients for sleep disordered breathing, narcolepsy, parasomnias, restless leg syndrome and insomnia.

Jessie Wrobel is a board-certified Family Nurse Practitioner. She earned a Bachelor of Science in Nursing from Southern Connecticut State University, concurrently graduating from their Honor’s College in 2009 and spent 9 years at the bedside focusing on heart failure and stroke populations. She then obtained a Master of Science in Nursing from Southern Connecticut State University and holds a certification with the American Academy of Nurse Practitioners (AANP) as a family nurse practitioner. She has since worked at Yale-New Haven’s Sleep Medicine Center where she follows patients for sleep disordered breathing, narcolepsy, parasomnias, restless leg syndrome and insomnia.

Pfizer asked the FDA on Thursday to expand emergency use authorization of its COVID-19 vaccine to children ages 5 to 11.

The request comes after the drugmaker submitted clinical trial data to the FDA on Sept. 28. Pfizer said the study of 2,268 children showed the vaccine was safe and produced a robust immune response.

Participants in the studies received a lower dose of the vaccine, 10 micrograms. Their response 2 weeks after a second dose was reportedly equal to the immune protection in a control group of 16- to 25-year-olds who received the fully approved 30-microgram doses.

Currently, the Pfizer EUA applies to 12- to 15-year-olds and people eligible for a Pfizer booster shot. The drugmaker received full FDA approval for the vaccine for Americans 16 years and older in August.

The filing for authorization in 5- to 11-year-olds comes as overall cases of COVID-19 in the United States continue to decline. The decrease includes a drop in new cases in children for the fourth consecutive week, according to analysis of data from the American Academy of Pediatrics and the Children’s Hospital Association.

The next step is an FDA decision on whether to expand the current emergency use authorization (EUA) for teenagers to the younger age group.

Timing of any official word from the agency is unknown. But possibly in anticipation of today’s filing, the FDA already scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for Oct. 25.

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

Pfizer asked the FDA on Thursday to expand emergency use authorization of its COVID-19 vaccine to children ages 5 to 11.

The request comes after the drugmaker submitted clinical trial data to the FDA on Sept. 28. Pfizer said the study of 2,268 children showed the vaccine was safe and produced a robust immune response.

Participants in the studies received a lower dose of the vaccine, 10 micrograms. Their response 2 weeks after a second dose was reportedly equal to the immune protection in a control group of 16- to 25-year-olds who received the fully approved 30-microgram doses.

Currently, the Pfizer EUA applies to 12- to 15-year-olds and people eligible for a Pfizer booster shot. The drugmaker received full FDA approval for the vaccine for Americans 16 years and older in August.

The filing for authorization in 5- to 11-year-olds comes as overall cases of COVID-19 in the United States continue to decline. The decrease includes a drop in new cases in children for the fourth consecutive week, according to analysis of data from the American Academy of Pediatrics and the Children’s Hospital Association.

The next step is an FDA decision on whether to expand the current emergency use authorization (EUA) for teenagers to the younger age group.

Timing of any official word from the agency is unknown. But possibly in anticipation of today’s filing, the FDA already scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for Oct. 25.

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

Pfizer asked the FDA on Thursday to expand emergency use authorization of its COVID-19 vaccine to children ages 5 to 11.

The request comes after the drugmaker submitted clinical trial data to the FDA on Sept. 28. Pfizer said the study of 2,268 children showed the vaccine was safe and produced a robust immune response.

Participants in the studies received a lower dose of the vaccine, 10 micrograms. Their response 2 weeks after a second dose was reportedly equal to the immune protection in a control group of 16- to 25-year-olds who received the fully approved 30-microgram doses.

Currently, the Pfizer EUA applies to 12- to 15-year-olds and people eligible for a Pfizer booster shot. The drugmaker received full FDA approval for the vaccine for Americans 16 years and older in August.

The filing for authorization in 5- to 11-year-olds comes as overall cases of COVID-19 in the United States continue to decline. The decrease includes a drop in new cases in children for the fourth consecutive week, according to analysis of data from the American Academy of Pediatrics and the Children’s Hospital Association.

The next step is an FDA decision on whether to expand the current emergency use authorization (EUA) for teenagers to the younger age group.

Timing of any official word from the agency is unknown. But possibly in anticipation of today’s filing, the FDA already scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee for Oct. 25.

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

A drug approved to treat constipation appears to improve cognitive impairment and boost brain activity for patients with mental illness, new research suggests.

In a randomized controlled trial, 44 healthy individuals were assigned to receive the selective serotonin-4 (5-HT4) receptor agonist prucalopride (Motegrity) or placebo for 1 week.

After 6 days, the active-treatment group performed significantly better on memory tests than the participants who received placebo. In addition, the drug increased activity in brain areas related to cognition.

“What we’re hoping is...these agents may be able to help those with cognitive impairment as part of their mental illness,” lead author Angharad N. de Cates, a clinical DPhil student in the department of psychiatry, University of Oxford, Oxford, United Kingdom, told meeting attendees.

“Currently, we’re looking to see if we can translate our finding a step further and do a similar study in those with depression,” Ms. de Cates added.

The findings were presented at the 34th European College of Neuropsychopharmacology (ECNP) Congress and were simultaneously published in Translational Psychiatry.
 

“Exciting early evidence”

“Even when the low mood associated with depression is well-treated with conventional antidepressants, many patients continue to experience problems with their memory,” co-investigator Susannah Murphy, PhD, a senior research fellow at the University of Oxford, said in a release.

“Our study provides exciting early evidence in humans of a new approach that might be a helpful way to treat these residual cognitive symptoms,” Dr. Murphy added.

Preclinical and animal studies suggest that the 5-HT4 receptor is a promising treatment target for cognitive impairment in individuals with psychiatric disorders, although studies in humans have been limited by the adverse effects of early agents.

“We’ve had our eye on this receptor for a while,” explained de Cates, inasmuch as the animal data “have been so good.”

However, she said in an interview that “a lack of safe human agents made translation tricky.”

As previously reported, prucalopride, a selective high-affinity 5-HT4 partial agonist, was approved in 2018 by the U.S. Food and Drug Administration for the treatment of chronic idiopathic constipation.

The current researchers note that the drug has “good brain penetration,” which “allowed us to investigate 5-HT4-receptor agonism in humans.”

Having previously shown that a single dose of the drug has “pro-cognitive effects,” the investigators conducted the new trial in 44 healthy participants. All were randomly assigned in a 1:1 ratio to receive either prucalopride 1 mg for 7 days or placebo.

In accordance with enrollment criteria, patients were 18 to 36 years of age, right-handed, and were not pregnant or breastfeeding. Participants’ body mass index was 18 to 30 kg/m², and they had no contraindications to the study drug. The two treatment groups were well balanced; the participants who received placebo were significantly more likely to be nonnative English speakers (P = .02).

On day 6 of treatment administration, all participants underwent 3T MRI.

Before undergoing imaging, the participants were presented with eight emotionally neutral images of animals or landscapes and were asked to indicate whether or not the images were of animals. The task was then repeated with the eight familiar images and eight novel ones.

During the scan, participants were shown the same images or eight novel images and were again asked whether or not the images contained an animal. They were also instructed to try to remember the images for a subsequent memory task. In that task, the eight original images, 48 novel images, and 27 “distractor” images were presented.
 

Better memory

In the pre-scan assessment, results showed no significant differences in the ability of members of the prucalopride and placebo groups to identify images as being familiar or different.

However, taking prucalopride was associated with significantly improved memory performance in the post-scan recall task.

Compared to the placebo group, participants in the prucalopride group were more accurate in selecting images as familiar vs distractors (P = .029) and in distinguishing images as familiar, novel, or distractors (P = .035).

Functional MRI revealed increased activity in the left and right hippocampus in response to both novel and familiar images among the participants in the prucalopride group in comparison with those in the placebo group.

There was also increased activity in the right angular gyrus in the prucalopride group in comparison with the placebo group in response to familiar images (P < .005).

“Clinically, angular gyri lesions cause language dysfunction, low mood, and poor memory and can mimic dementia or pseudodementia,” the investigators write. They note that the right angular gyrus “shows significantly decreased activity” in mild cognitive impairment.

“Therefore, the increased activity seen in the right angular gyrus following prucalopride administration in our study is consistent with the pro-cognitive behavioural effects we observed,” they add.

Ms. De Cates noted that the dose used in their study was lower than the 2 mg given for constipation.

“At the low dose, there were no differences in side effects between groups and no withdrawals from the prucalopride group for side effects. We are going to try increasing the dose in our next study actually, as we don’t have PET data to tell us what the optimal dose for binding at the receptor should be,” said Ms. de Cates.

“In safety studies, the dose was trialled in healthy volunteers at 4 mg, which was found to be safe, although perhaps less well tolerated than 2 mg,” she said.
 

Generalizable findings?

Commenting on the research, Vibe G. Frøkjær, MD, adjunct professor, department of psychology, Copenhagen University, Denmark, said the study “highlights a very interesting and much needed potential for repurposing drugs to help cognitive dysfunction.”

He noted that cognitive dysfunction is often associated with psychiatric disorders -- even in states of remission.

“Importantly, as the authors also state, it will be vital to translate these findings from healthy populations into clinical populations,” said Dr. Frøkjær, who was not involved in the research.

“It will also be important to understand if prucalopride adds to the effects of existing antidepressant treatments or can be used as a stand-alone therapy,” he added.

The study was funded by the NIHR Oxford Health Biomedical Research Center and by the Wellcome Center for Integrative Neuroscience. Ms. De Cates has received a travel grant from the Royal College of Psychiatrists/Gatsby Foundation and support from Wellcome. The other authors have relationships with P1vital Ltd, Janssen Pharmaceuticals, Sage Therapeutics, Pfizer, Zogenix, Compass Pathways, and Lundbeck.

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

A drug approved to treat constipation appears to improve cognitive impairment and boost brain activity for patients with mental illness, new research suggests.

In a randomized controlled trial, 44 healthy individuals were assigned to receive the selective serotonin-4 (5-HT4) receptor agonist prucalopride (Motegrity) or placebo for 1 week.

After 6 days, the active-treatment group performed significantly better on memory tests than the participants who received placebo. In addition, the drug increased activity in brain areas related to cognition.

“What we’re hoping is...these agents may be able to help those with cognitive impairment as part of their mental illness,” lead author Angharad N. de Cates, a clinical DPhil student in the department of psychiatry, University of Oxford, Oxford, United Kingdom, told meeting attendees.

“Currently, we’re looking to see if we can translate our finding a step further and do a similar study in those with depression,” Ms. de Cates added.

The findings were presented at the 34th European College of Neuropsychopharmacology (ECNP) Congress and were simultaneously published in Translational Psychiatry.
 

“Exciting early evidence”

“Even when the low mood associated with depression is well-treated with conventional antidepressants, many patients continue to experience problems with their memory,” co-investigator Susannah Murphy, PhD, a senior research fellow at the University of Oxford, said in a release.

“Our study provides exciting early evidence in humans of a new approach that might be a helpful way to treat these residual cognitive symptoms,” Dr. Murphy added.

Preclinical and animal studies suggest that the 5-HT4 receptor is a promising treatment target for cognitive impairment in individuals with psychiatric disorders, although studies in humans have been limited by the adverse effects of early agents.

“We’ve had our eye on this receptor for a while,” explained de Cates, inasmuch as the animal data “have been so good.”

However, she said in an interview that “a lack of safe human agents made translation tricky.”

As previously reported, prucalopride, a selective high-affinity 5-HT4 partial agonist, was approved in 2018 by the U.S. Food and Drug Administration for the treatment of chronic idiopathic constipation.

The current researchers note that the drug has “good brain penetration,” which “allowed us to investigate 5-HT4-receptor agonism in humans.”

Having previously shown that a single dose of the drug has “pro-cognitive effects,” the investigators conducted the new trial in 44 healthy participants. All were randomly assigned in a 1:1 ratio to receive either prucalopride 1 mg for 7 days or placebo.

In accordance with enrollment criteria, patients were 18 to 36 years of age, right-handed, and were not pregnant or breastfeeding. Participants’ body mass index was 18 to 30 kg/m², and they had no contraindications to the study drug. The two treatment groups were well balanced; the participants who received placebo were significantly more likely to be nonnative English speakers (P = .02).

On day 6 of treatment administration, all participants underwent 3T MRI.

Before undergoing imaging, the participants were presented with eight emotionally neutral images of animals or landscapes and were asked to indicate whether or not the images were of animals. The task was then repeated with the eight familiar images and eight novel ones.

During the scan, participants were shown the same images or eight novel images and were again asked whether or not the images contained an animal. They were also instructed to try to remember the images for a subsequent memory task. In that task, the eight original images, 48 novel images, and 27 “distractor” images were presented.
 

Better memory

In the pre-scan assessment, results showed no significant differences in the ability of members of the prucalopride and placebo groups to identify images as being familiar or different.

However, taking prucalopride was associated with significantly improved memory performance in the post-scan recall task.

Compared to the placebo group, participants in the prucalopride group were more accurate in selecting images as familiar vs distractors (P = .029) and in distinguishing images as familiar, novel, or distractors (P = .035).

Functional MRI revealed increased activity in the left and right hippocampus in response to both novel and familiar images among the participants in the prucalopride group in comparison with those in the placebo group.

There was also increased activity in the right angular gyrus in the prucalopride group in comparison with the placebo group in response to familiar images (P < .005).

“Clinically, angular gyri lesions cause language dysfunction, low mood, and poor memory and can mimic dementia or pseudodementia,” the investigators write. They note that the right angular gyrus “shows significantly decreased activity” in mild cognitive impairment.

“Therefore, the increased activity seen in the right angular gyrus following prucalopride administration in our study is consistent with the pro-cognitive behavioural effects we observed,” they add.

Ms. De Cates noted that the dose used in their study was lower than the 2 mg given for constipation.

“At the low dose, there were no differences in side effects between groups and no withdrawals from the prucalopride group for side effects. We are going to try increasing the dose in our next study actually, as we don’t have PET data to tell us what the optimal dose for binding at the receptor should be,” said Ms. de Cates.

“In safety studies, the dose was trialled in healthy volunteers at 4 mg, which was found to be safe, although perhaps less well tolerated than 2 mg,” she said.
 

Generalizable findings?

Commenting on the research, Vibe G. Frøkjær, MD, adjunct professor, department of psychology, Copenhagen University, Denmark, said the study “highlights a very interesting and much needed potential for repurposing drugs to help cognitive dysfunction.”

He noted that cognitive dysfunction is often associated with psychiatric disorders -- even in states of remission.

“Importantly, as the authors also state, it will be vital to translate these findings from healthy populations into clinical populations,” said Dr. Frøkjær, who was not involved in the research.

“It will also be important to understand if prucalopride adds to the effects of existing antidepressant treatments or can be used as a stand-alone therapy,” he added.

The study was funded by the NIHR Oxford Health Biomedical Research Center and by the Wellcome Center for Integrative Neuroscience. Ms. De Cates has received a travel grant from the Royal College of Psychiatrists/Gatsby Foundation and support from Wellcome. The other authors have relationships with P1vital Ltd, Janssen Pharmaceuticals, Sage Therapeutics, Pfizer, Zogenix, Compass Pathways, and Lundbeck.

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

A drug approved to treat constipation appears to improve cognitive impairment and boost brain activity for patients with mental illness, new research suggests.

In a randomized controlled trial, 44 healthy individuals were assigned to receive the selective serotonin-4 (5-HT4) receptor agonist prucalopride (Motegrity) or placebo for 1 week.

After 6 days, the active-treatment group performed significantly better on memory tests than the participants who received placebo. In addition, the drug increased activity in brain areas related to cognition.

“What we’re hoping is...these agents may be able to help those with cognitive impairment as part of their mental illness,” lead author Angharad N. de Cates, a clinical DPhil student in the department of psychiatry, University of Oxford, Oxford, United Kingdom, told meeting attendees.

“Currently, we’re looking to see if we can translate our finding a step further and do a similar study in those with depression,” Ms. de Cates added.

The findings were presented at the 34th European College of Neuropsychopharmacology (ECNP) Congress and were simultaneously published in Translational Psychiatry.
 

“Exciting early evidence”

“Even when the low mood associated with depression is well-treated with conventional antidepressants, many patients continue to experience problems with their memory,” co-investigator Susannah Murphy, PhD, a senior research fellow at the University of Oxford, said in a release.

“Our study provides exciting early evidence in humans of a new approach that might be a helpful way to treat these residual cognitive symptoms,” Dr. Murphy added.

Preclinical and animal studies suggest that the 5-HT4 receptor is a promising treatment target for cognitive impairment in individuals with psychiatric disorders, although studies in humans have been limited by the adverse effects of early agents.

“We’ve had our eye on this receptor for a while,” explained de Cates, inasmuch as the animal data “have been so good.”

However, she said in an interview that “a lack of safe human agents made translation tricky.”

As previously reported, prucalopride, a selective high-affinity 5-HT4 partial agonist, was approved in 2018 by the U.S. Food and Drug Administration for the treatment of chronic idiopathic constipation.

The current researchers note that the drug has “good brain penetration,” which “allowed us to investigate 5-HT4-receptor agonism in humans.”

Having previously shown that a single dose of the drug has “pro-cognitive effects,” the investigators conducted the new trial in 44 healthy participants. All were randomly assigned in a 1:1 ratio to receive either prucalopride 1 mg for 7 days or placebo.

In accordance with enrollment criteria, patients were 18 to 36 years of age, right-handed, and were not pregnant or breastfeeding. Participants’ body mass index was 18 to 30 kg/m², and they had no contraindications to the study drug. The two treatment groups were well balanced; the participants who received placebo were significantly more likely to be nonnative English speakers (P = .02).

On day 6 of treatment administration, all participants underwent 3T MRI.

Before undergoing imaging, the participants were presented with eight emotionally neutral images of animals or landscapes and were asked to indicate whether or not the images were of animals. The task was then repeated with the eight familiar images and eight novel ones.

During the scan, participants were shown the same images or eight novel images and were again asked whether or not the images contained an animal. They were also instructed to try to remember the images for a subsequent memory task. In that task, the eight original images, 48 novel images, and 27 “distractor” images were presented.
 

Better memory

In the pre-scan assessment, results showed no significant differences in the ability of members of the prucalopride and placebo groups to identify images as being familiar or different.

However, taking prucalopride was associated with significantly improved memory performance in the post-scan recall task.

Compared to the placebo group, participants in the prucalopride group were more accurate in selecting images as familiar vs distractors (P = .029) and in distinguishing images as familiar, novel, or distractors (P = .035).

Functional MRI revealed increased activity in the left and right hippocampus in response to both novel and familiar images among the participants in the prucalopride group in comparison with those in the placebo group.

There was also increased activity in the right angular gyrus in the prucalopride group in comparison with the placebo group in response to familiar images (P < .005).

“Clinically, angular gyri lesions cause language dysfunction, low mood, and poor memory and can mimic dementia or pseudodementia,” the investigators write. They note that the right angular gyrus “shows significantly decreased activity” in mild cognitive impairment.

“Therefore, the increased activity seen in the right angular gyrus following prucalopride administration in our study is consistent with the pro-cognitive behavioural effects we observed,” they add.

Ms. De Cates noted that the dose used in their study was lower than the 2 mg given for constipation.

“At the low dose, there were no differences in side effects between groups and no withdrawals from the prucalopride group for side effects. We are going to try increasing the dose in our next study actually, as we don’t have PET data to tell us what the optimal dose for binding at the receptor should be,” said Ms. de Cates.

“In safety studies, the dose was trialled in healthy volunteers at 4 mg, which was found to be safe, although perhaps less well tolerated than 2 mg,” she said.
 

Generalizable findings?

Commenting on the research, Vibe G. Frøkjær, MD, adjunct professor, department of psychology, Copenhagen University, Denmark, said the study “highlights a very interesting and much needed potential for repurposing drugs to help cognitive dysfunction.”

He noted that cognitive dysfunction is often associated with psychiatric disorders -- even in states of remission.

“Importantly, as the authors also state, it will be vital to translate these findings from healthy populations into clinical populations,” said Dr. Frøkjær, who was not involved in the research.

“It will also be important to understand if prucalopride adds to the effects of existing antidepressant treatments or can be used as a stand-alone therapy,” he added.

The study was funded by the NIHR Oxford Health Biomedical Research Center and by the Wellcome Center for Integrative Neuroscience. Ms. De Cates has received a travel grant from the Royal College of Psychiatrists/Gatsby Foundation and support from Wellcome. The other authors have relationships with P1vital Ltd, Janssen Pharmaceuticals, Sage Therapeutics, Pfizer, Zogenix, Compass Pathways, and Lundbeck.

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

In patients with moderate to severe atopic dermatitis (AD), abrocitinib, an oral JAK inhibitor, relieved itch more quickly than the monoclonal antibody dupilumab (Dupixent), in a multicenter randomized trial presented as a late breaker at the annual meeting of the European Academy of Dermatology and Venereology.

The earlier onset of action with the JAK inhibitor was achieved even though most patients in both arms were on topical corticosteroids, a design element that “is clinically relevant” for a practical comparison of these two agents, according to Kristian Reich, MD, PhD, Center for Translational Research in Inflammatory Skin Diseases, University Medical Center, Hamburg-Eppendorf, Germany.    

The goal of this phase 3b trial, called JADE DARE, was to compare relative safety and efficacy of these strategies over the early course of treatment, he said.
 

Over 700 patients randomized

JADE DARE enrolled 727 patients over age 18 years who previously had an inadequate response to conventional topical therapies. All had moderate to severe AD defined by criteria such as body surface area greater than or equal to 10% and Eczema Area Severity Index (EASI) greater than or equal to 16. They were randomly assigned to 200 mg oral abrocitinib once daily or 300 mg subcutaneous dupilumab (after a loading dose of 600 mg) every 2 weeks. A double-dummy design preserved blinding.

The coprimary endpoints were at least a 4-point improvement in pruritus as measured with the Peak Pruritus Numerical Rating Scale (PP-NRS) score at week 2 and at least a 90% improvement in the EASI (EASI 90) at week 4.

The primary endpoint for pruritus at 2 weeks was reached by nearly twice as many patients randomly assigned to abrocitinib (46.2% vs. 25.5%; P < .001). The proportion of those meeting the EASI 90 endpoint at week 4 was also superior on abrocitinib (28.5% vs. 14.6%; P < .001)
 

Advantage for pruritus control dissipates

For the pruritus endpoint, the advantage of abrocitinib slowly diminished over time after the peak difference observed at 2 weeks. Although the advantage at week 4 (58.1% vs. 40.8%) and week 8 (65.8% vs. 52.7%) remained sizable, there were very small differences thereafter. However, Dr. Reich pointed out that the percentages continued to favor abrocitinib at least numerically through the 26 weeks of follow-up completed so far.

The pattern of response on EASI 90 was not the same. After demonstrating superiority at the 4-week timepoint, the advantage of abrocitinib persisted. When compared at week 16, which was a secondary endpoint of the JADE DARE trial, the advantage of abrocitinib remained significant (54.3% vs. 41.9%; P < .001). The advantage of abrocitinib narrowed but remained numerically superior at 26 weeks (54.6% vs. 47.6%).

Based on the data collected to date, “abrocitinib is clearly superior early on,” Dr. Reich said. Moreover, he reiterated that topical corticosteroids were allowed as background therapy in both arms.

“It is difficult to show an advantage for one active therapy over the other in patients on background corticosteroids,” Dr. Reich maintained.
 

Both drugs are well tolerated

The drugs were similarly well tolerated. Serious adverse events were uncommon in either arm. The rate of study dropouts due to an adverse event potentially related to treatment assignment was 3% in each group.

Nausea (19% vs. 2%), acne (13.5% vs. 2%), and headache (13% vs. 7.5%) were all more common in patients randomly assigned to abrocitinib. Conjunctivitis was more common in the group randomly assigned to dupilumab (10% vs. 2%).

The two deaths that occurred during this study were in the abrocitinib arm, but one was the result of COVID-19 infection and the other was a cardiovascular event in a patient with risk factors. Neither was considered to be treatment-related.

Abrocitinib’s relative selectivity for the JAK1 inhibitor is a potential differentiator from other currently available JAK inhibitors, although direct comparisons of these therapies for clinical activity in AD as well as most other diseases remains limited.

The relatively rapid relief of pruritus with the JAK inhibitor relative to the monoclonal antibody in the JADE DARE trial is likely to be perceived as clinically significant by patients with AD, according to Sonja Ständer, MD, professor of dermatology and neurodermatology at the University Hospital Münster, Germany.

“One of the highest needs of patients with atopic dermatitis is a rapid and profound relief of itch,” Dr. Ständer, who wrote a review article on AD earlier this year, said in an interview.

Although several current therapies are effective against pruritus, Dr. Ständer believes that the higher proportion of patients achieving itch control at 2 weeks on abrocitinib “will attract the attention of affected patients.”

However, she added that patients need to take both benefits and risks into account, indicating that clinical utility cannot be judged on a single outcome. In selecting one drug over the others, she advised “a balanced use of therapies.”

Abrocitinib was first approved in the United Kingdom in early September, followed by Japan last Thursday, for the treatment of moderate to severe AD in patients ages 12 and older. It is under review elsewhere, including in the United States and the European Union for AD.  

In September, the FDA approved the first JAK inhibitor for treating AD – a topical JAK inhibitor, ruxolitinib.

Dr. Reich reports financial relationships with 20 pharmaceutical companies, including Pfizer, which provided funding for the JADE DARE trial. Dr. Ständer reports financial relationships with Beiersdorf AG, Galderma, Kliniska, Lilly, Pfizer, and Sanofi.

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

In patients with moderate to severe atopic dermatitis (AD), abrocitinib, an oral JAK inhibitor, relieved itch more quickly than the monoclonal antibody dupilumab (Dupixent), in a multicenter randomized trial presented as a late breaker at the annual meeting of the European Academy of Dermatology and Venereology.

The earlier onset of action with the JAK inhibitor was achieved even though most patients in both arms were on topical corticosteroids, a design element that “is clinically relevant” for a practical comparison of these two agents, according to Kristian Reich, MD, PhD, Center for Translational Research in Inflammatory Skin Diseases, University Medical Center, Hamburg-Eppendorf, Germany.    

The goal of this phase 3b trial, called JADE DARE, was to compare relative safety and efficacy of these strategies over the early course of treatment, he said.
 

Over 700 patients randomized

JADE DARE enrolled 727 patients over age 18 years who previously had an inadequate response to conventional topical therapies. All had moderate to severe AD defined by criteria such as body surface area greater than or equal to 10% and Eczema Area Severity Index (EASI) greater than or equal to 16. They were randomly assigned to 200 mg oral abrocitinib once daily or 300 mg subcutaneous dupilumab (after a loading dose of 600 mg) every 2 weeks. A double-dummy design preserved blinding.

The coprimary endpoints were at least a 4-point improvement in pruritus as measured with the Peak Pruritus Numerical Rating Scale (PP-NRS) score at week 2 and at least a 90% improvement in the EASI (EASI 90) at week 4.

The primary endpoint for pruritus at 2 weeks was reached by nearly twice as many patients randomly assigned to abrocitinib (46.2% vs. 25.5%; P < .001). The proportion of those meeting the EASI 90 endpoint at week 4 was also superior on abrocitinib (28.5% vs. 14.6%; P < .001)
 

Advantage for pruritus control dissipates

For the pruritus endpoint, the advantage of abrocitinib slowly diminished over time after the peak difference observed at 2 weeks. Although the advantage at week 4 (58.1% vs. 40.8%) and week 8 (65.8% vs. 52.7%) remained sizable, there were very small differences thereafter. However, Dr. Reich pointed out that the percentages continued to favor abrocitinib at least numerically through the 26 weeks of follow-up completed so far.

The pattern of response on EASI 90 was not the same. After demonstrating superiority at the 4-week timepoint, the advantage of abrocitinib persisted. When compared at week 16, which was a secondary endpoint of the JADE DARE trial, the advantage of abrocitinib remained significant (54.3% vs. 41.9%; P < .001). The advantage of abrocitinib narrowed but remained numerically superior at 26 weeks (54.6% vs. 47.6%).

Based on the data collected to date, “abrocitinib is clearly superior early on,” Dr. Reich said. Moreover, he reiterated that topical corticosteroids were allowed as background therapy in both arms.

“It is difficult to show an advantage for one active therapy over the other in patients on background corticosteroids,” Dr. Reich maintained.
 

Both drugs are well tolerated

The drugs were similarly well tolerated. Serious adverse events were uncommon in either arm. The rate of study dropouts due to an adverse event potentially related to treatment assignment was 3% in each group.

Nausea (19% vs. 2%), acne (13.5% vs. 2%), and headache (13% vs. 7.5%) were all more common in patients randomly assigned to abrocitinib. Conjunctivitis was more common in the group randomly assigned to dupilumab (10% vs. 2%).

The two deaths that occurred during this study were in the abrocitinib arm, but one was the result of COVID-19 infection and the other was a cardiovascular event in a patient with risk factors. Neither was considered to be treatment-related.

Abrocitinib’s relative selectivity for the JAK1 inhibitor is a potential differentiator from other currently available JAK inhibitors, although direct comparisons of these therapies for clinical activity in AD as well as most other diseases remains limited.

The relatively rapid relief of pruritus with the JAK inhibitor relative to the monoclonal antibody in the JADE DARE trial is likely to be perceived as clinically significant by patients with AD, according to Sonja Ständer, MD, professor of dermatology and neurodermatology at the University Hospital Münster, Germany.

“One of the highest needs of patients with atopic dermatitis is a rapid and profound relief of itch,” Dr. Ständer, who wrote a review article on AD earlier this year, said in an interview.

Although several current therapies are effective against pruritus, Dr. Ständer believes that the higher proportion of patients achieving itch control at 2 weeks on abrocitinib “will attract the attention of affected patients.”

However, she added that patients need to take both benefits and risks into account, indicating that clinical utility cannot be judged on a single outcome. In selecting one drug over the others, she advised “a balanced use of therapies.”

Abrocitinib was first approved in the United Kingdom in early September, followed by Japan last Thursday, for the treatment of moderate to severe AD in patients ages 12 and older. It is under review elsewhere, including in the United States and the European Union for AD.  

In September, the FDA approved the first JAK inhibitor for treating AD – a topical JAK inhibitor, ruxolitinib.

Dr. Reich reports financial relationships with 20 pharmaceutical companies, including Pfizer, which provided funding for the JADE DARE trial. Dr. Ständer reports financial relationships with Beiersdorf AG, Galderma, Kliniska, Lilly, Pfizer, and Sanofi.

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

In patients with moderate to severe atopic dermatitis (AD), abrocitinib, an oral JAK inhibitor, relieved itch more quickly than the monoclonal antibody dupilumab (Dupixent), in a multicenter randomized trial presented as a late breaker at the annual meeting of the European Academy of Dermatology and Venereology.

The earlier onset of action with the JAK inhibitor was achieved even though most patients in both arms were on topical corticosteroids, a design element that “is clinically relevant” for a practical comparison of these two agents, according to Kristian Reich, MD, PhD, Center for Translational Research in Inflammatory Skin Diseases, University Medical Center, Hamburg-Eppendorf, Germany.    

The goal of this phase 3b trial, called JADE DARE, was to compare relative safety and efficacy of these strategies over the early course of treatment, he said.
 

Over 700 patients randomized

JADE DARE enrolled 727 patients over age 18 years who previously had an inadequate response to conventional topical therapies. All had moderate to severe AD defined by criteria such as body surface area greater than or equal to 10% and Eczema Area Severity Index (EASI) greater than or equal to 16. They were randomly assigned to 200 mg oral abrocitinib once daily or 300 mg subcutaneous dupilumab (after a loading dose of 600 mg) every 2 weeks. A double-dummy design preserved blinding.

The coprimary endpoints were at least a 4-point improvement in pruritus as measured with the Peak Pruritus Numerical Rating Scale (PP-NRS) score at week 2 and at least a 90% improvement in the EASI (EASI 90) at week 4.

The primary endpoint for pruritus at 2 weeks was reached by nearly twice as many patients randomly assigned to abrocitinib (46.2% vs. 25.5%; P < .001). The proportion of those meeting the EASI 90 endpoint at week 4 was also superior on abrocitinib (28.5% vs. 14.6%; P < .001)
 

Advantage for pruritus control dissipates

For the pruritus endpoint, the advantage of abrocitinib slowly diminished over time after the peak difference observed at 2 weeks. Although the advantage at week 4 (58.1% vs. 40.8%) and week 8 (65.8% vs. 52.7%) remained sizable, there were very small differences thereafter. However, Dr. Reich pointed out that the percentages continued to favor abrocitinib at least numerically through the 26 weeks of follow-up completed so far.

The pattern of response on EASI 90 was not the same. After demonstrating superiority at the 4-week timepoint, the advantage of abrocitinib persisted. When compared at week 16, which was a secondary endpoint of the JADE DARE trial, the advantage of abrocitinib remained significant (54.3% vs. 41.9%; P < .001). The advantage of abrocitinib narrowed but remained numerically superior at 26 weeks (54.6% vs. 47.6%).

Based on the data collected to date, “abrocitinib is clearly superior early on,” Dr. Reich said. Moreover, he reiterated that topical corticosteroids were allowed as background therapy in both arms.

“It is difficult to show an advantage for one active therapy over the other in patients on background corticosteroids,” Dr. Reich maintained.
 

Both drugs are well tolerated

The drugs were similarly well tolerated. Serious adverse events were uncommon in either arm. The rate of study dropouts due to an adverse event potentially related to treatment assignment was 3% in each group.

Nausea (19% vs. 2%), acne (13.5% vs. 2%), and headache (13% vs. 7.5%) were all more common in patients randomly assigned to abrocitinib. Conjunctivitis was more common in the group randomly assigned to dupilumab (10% vs. 2%).

The two deaths that occurred during this study were in the abrocitinib arm, but one was the result of COVID-19 infection and the other was a cardiovascular event in a patient with risk factors. Neither was considered to be treatment-related.

Abrocitinib’s relative selectivity for the JAK1 inhibitor is a potential differentiator from other currently available JAK inhibitors, although direct comparisons of these therapies for clinical activity in AD as well as most other diseases remains limited.

The relatively rapid relief of pruritus with the JAK inhibitor relative to the monoclonal antibody in the JADE DARE trial is likely to be perceived as clinically significant by patients with AD, according to Sonja Ständer, MD, professor of dermatology and neurodermatology at the University Hospital Münster, Germany.

“One of the highest needs of patients with atopic dermatitis is a rapid and profound relief of itch,” Dr. Ständer, who wrote a review article on AD earlier this year, said in an interview.

Although several current therapies are effective against pruritus, Dr. Ständer believes that the higher proportion of patients achieving itch control at 2 weeks on abrocitinib “will attract the attention of affected patients.”

However, she added that patients need to take both benefits and risks into account, indicating that clinical utility cannot be judged on a single outcome. In selecting one drug over the others, she advised “a balanced use of therapies.”

Abrocitinib was first approved in the United Kingdom in early September, followed by Japan last Thursday, for the treatment of moderate to severe AD in patients ages 12 and older. It is under review elsewhere, including in the United States and the European Union for AD.  

In September, the FDA approved the first JAK inhibitor for treating AD – a topical JAK inhibitor, ruxolitinib.

Dr. Reich reports financial relationships with 20 pharmaceutical companies, including Pfizer, which provided funding for the JADE DARE trial. Dr. Ständer reports financial relationships with Beiersdorf AG, Galderma, Kliniska, Lilly, Pfizer, and Sanofi.

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

An 8-year-old girl who was infected with SARS-CoV-2 died after developing an extremely rare condition known as acute fulminant cerebral edema (AFCE), according to pediatric neurologists who are urging colleagues to watch out for similar cases.

At least one other child in the United States has died after becoming infected with the virus and developing cerebral edema. “The rapid and devastating clinical course in both of these cases highlights the need for early recognition of a cerebral edema and AFCE as potential complications of COVID-19 in pediatric patients,” the neurologists wrote.

The case was highlighted in a poster presented at the annual meeting of the Child Neurology Society and in a report published earlier this year in Child Neurology Open.

According to pediatric neurologist Timothy Gershon, MD, PhD , of the University of North Carolina at Chapel Hill, the child appeared in clinic in July 2020. She had been healthy but was suffering from 1 day of fever, seizure-like activity (generalized convulsions and drooling), anorexia, and lethargy.

The girl, who was subsequently diagnosed with COVID-19, deteriorated in the hospital. “She received IV dexamethasone in attempts to reduce cerebral edema,” the neurologists wrote. “Regarding immunomodulatory therapy, she received intravenous immunoglobulin (2 g/kg), anakinra, and hydrocortisone; despite approval for remdesivir and COVID-19 convalescent plasma, these were ultimately withheld due to poor prognosis.”

Brain death examinations at 24 and 48 hours after cardiac arrest were consistent with brain death, they reported.

Neurologists believe the patient suffered from AFCE, “an often fatal pediatric clinical entity consisting of fever, encephalopathy, and new-onset seizures followed by rapid, diffuse, and medically-refractory cerebral edema.” They add that “AFCE occurs as a rare complication of a variety of common pediatric infections, and a CNS [central nervous system] pathogen is identified in only a minority of cases, suggesting a para-infectious mechanism of edema.”

Neurologists offered a case definition of the “recently recognized” AFCE earlier this year.

“This was an extremely rare rapid progression to cerebral edema. I think it was related to the patient’s COVID infection, but why this patient got it and others don’t is unknown,” Dr. Gershon said in an interview. “The full spectrum of neurological complications of COVID were not yet known [at the time]. We didn’t know, and still don’t know, what the causative links are between COVID and suddenly having seizures and brain swelling.”

He said he’d treat a similar patient differently now and give dexamethasone earlier in the clinical course, although “there is no data to tell us if any therapy could have reversed it.” Specifically, he said, “I’d give dexamethasone at the first sign of brain involvement, using the dosing recommended for cerebral edema, and try to get the MRI earlier in the course.”

Dr. Gershon and colleagues noted another case of fatal cerebral edema in a child, a 7-year-old boy who was treated in New York state. That case “shows that fatal cerebral edema may complicate pediatric multisystem inflammatory syndrome,” they wrote.

Pediatric critical care specialist Preetha Krishnan, MD, of Randall Children’s Hospital at Legacy Emanuel in Portland, Ore., helped develop the new definition of AFCE. In an interview, she said AFCE is difficult to diagnose because the signs/symptoms – such as fever, altered sensorium, and seizures – are found in other conditions such as febrile status epilepticus with a viral illness. 
“The key to recognition of AFCE is that unlike other disease processes, these children have rapid neurologic progression,” she said. “In addition, many of our AFCE patients also had vomiting and/or headache, which in retrospect was likely an indication of elevated ICP [intracranial pressure] rather than viral infection.”
She added that “if a child with fever, seizures, and encephalopathy has cerebral edema on imaging and/or has neurologic progression, AFCE should be considered. Most of our cases of AFCE had fulminant progression within the first 3 days of their head imaging noting cerebral edema. There are other neurologic diseases, such as acute necrotizing encephalopathy of childhood, that also have progressive signs/symptoms, but head imaging and lab work should help differentiate many of these etiologies.”
In regard to treatment, she said, “our unit would likely err on the side of providing as much neuroprotective measures as is reasonable, such as maintaining normothermia, consideration of hyperosmolar therapy, maintaining normocarbia and normoxemia, managing seizures, etc. I would recommend getting the entire neurocritical care team involved in the management discussion. This varies by center, but will likely include neurology, ID [infectious disease], possibly neurosurgery, and PICU.”
As for the new case report, Krishnan said COVID-19 has been linked to neurologic complications, “so it does not surprise me that AFCE is part of the neurologic spectrum of disease.”
No funding was reported, and the authors report no relevant disclosures. Dr. Krishnan has no disclosures.

An 8-year-old girl who was infected with SARS-CoV-2 died after developing an extremely rare condition known as acute fulminant cerebral edema (AFCE), according to pediatric neurologists who are urging colleagues to watch out for similar cases.

At least one other child in the United States has died after becoming infected with the virus and developing cerebral edema. “The rapid and devastating clinical course in both of these cases highlights the need for early recognition of a cerebral edema and AFCE as potential complications of COVID-19 in pediatric patients,” the neurologists wrote.

The case was highlighted in a poster presented at the annual meeting of the Child Neurology Society and in a report published earlier this year in Child Neurology Open.

According to pediatric neurologist Timothy Gershon, MD, PhD , of the University of North Carolina at Chapel Hill, the child appeared in clinic in July 2020. She had been healthy but was suffering from 1 day of fever, seizure-like activity (generalized convulsions and drooling), anorexia, and lethargy.

The girl, who was subsequently diagnosed with COVID-19, deteriorated in the hospital. “She received IV dexamethasone in attempts to reduce cerebral edema,” the neurologists wrote. “Regarding immunomodulatory therapy, she received intravenous immunoglobulin (2 g/kg), anakinra, and hydrocortisone; despite approval for remdesivir and COVID-19 convalescent plasma, these were ultimately withheld due to poor prognosis.”

Brain death examinations at 24 and 48 hours after cardiac arrest were consistent with brain death, they reported.

Neurologists believe the patient suffered from AFCE, “an often fatal pediatric clinical entity consisting of fever, encephalopathy, and new-onset seizures followed by rapid, diffuse, and medically-refractory cerebral edema.” They add that “AFCE occurs as a rare complication of a variety of common pediatric infections, and a CNS [central nervous system] pathogen is identified in only a minority of cases, suggesting a para-infectious mechanism of edema.”

Neurologists offered a case definition of the “recently recognized” AFCE earlier this year.

“This was an extremely rare rapid progression to cerebral edema. I think it was related to the patient’s COVID infection, but why this patient got it and others don’t is unknown,” Dr. Gershon said in an interview. “The full spectrum of neurological complications of COVID were not yet known [at the time]. We didn’t know, and still don’t know, what the causative links are between COVID and suddenly having seizures and brain swelling.”

He said he’d treat a similar patient differently now and give dexamethasone earlier in the clinical course, although “there is no data to tell us if any therapy could have reversed it.” Specifically, he said, “I’d give dexamethasone at the first sign of brain involvement, using the dosing recommended for cerebral edema, and try to get the MRI earlier in the course.”

Dr. Gershon and colleagues noted another case of fatal cerebral edema in a child, a 7-year-old boy who was treated in New York state. That case “shows that fatal cerebral edema may complicate pediatric multisystem inflammatory syndrome,” they wrote.

Pediatric critical care specialist Preetha Krishnan, MD, of Randall Children’s Hospital at Legacy Emanuel in Portland, Ore., helped develop the new definition of AFCE. In an interview, she said AFCE is difficult to diagnose because the signs/symptoms – such as fever, altered sensorium, and seizures – are found in other conditions such as febrile status epilepticus with a viral illness. 
“The key to recognition of AFCE is that unlike other disease processes, these children have rapid neurologic progression,” she said. “In addition, many of our AFCE patients also had vomiting and/or headache, which in retrospect was likely an indication of elevated ICP [intracranial pressure] rather than viral infection.”
She added that “if a child with fever, seizures, and encephalopathy has cerebral edema on imaging and/or has neurologic progression, AFCE should be considered. Most of our cases of AFCE had fulminant progression within the first 3 days of their head imaging noting cerebral edema. There are other neurologic diseases, such as acute necrotizing encephalopathy of childhood, that also have progressive signs/symptoms, but head imaging and lab work should help differentiate many of these etiologies.”
In regard to treatment, she said, “our unit would likely err on the side of providing as much neuroprotective measures as is reasonable, such as maintaining normothermia, consideration of hyperosmolar therapy, maintaining normocarbia and normoxemia, managing seizures, etc. I would recommend getting the entire neurocritical care team involved in the management discussion. This varies by center, but will likely include neurology, ID [infectious disease], possibly neurosurgery, and PICU.”
As for the new case report, Krishnan said COVID-19 has been linked to neurologic complications, “so it does not surprise me that AFCE is part of the neurologic spectrum of disease.”
No funding was reported, and the authors report no relevant disclosures. Dr. Krishnan has no disclosures.

An 8-year-old girl who was infected with SARS-CoV-2 died after developing an extremely rare condition known as acute fulminant cerebral edema (AFCE), according to pediatric neurologists who are urging colleagues to watch out for similar cases.

At least one other child in the United States has died after becoming infected with the virus and developing cerebral edema. “The rapid and devastating clinical course in both of these cases highlights the need for early recognition of a cerebral edema and AFCE as potential complications of COVID-19 in pediatric patients,” the neurologists wrote.

The case was highlighted in a poster presented at the annual meeting of the Child Neurology Society and in a report published earlier this year in Child Neurology Open.

According to pediatric neurologist Timothy Gershon, MD, PhD , of the University of North Carolina at Chapel Hill, the child appeared in clinic in July 2020. She had been healthy but was suffering from 1 day of fever, seizure-like activity (generalized convulsions and drooling), anorexia, and lethargy.

The girl, who was subsequently diagnosed with COVID-19, deteriorated in the hospital. “She received IV dexamethasone in attempts to reduce cerebral edema,” the neurologists wrote. “Regarding immunomodulatory therapy, she received intravenous immunoglobulin (2 g/kg), anakinra, and hydrocortisone; despite approval for remdesivir and COVID-19 convalescent plasma, these were ultimately withheld due to poor prognosis.”

Brain death examinations at 24 and 48 hours after cardiac arrest were consistent with brain death, they reported.

Neurologists believe the patient suffered from AFCE, “an often fatal pediatric clinical entity consisting of fever, encephalopathy, and new-onset seizures followed by rapid, diffuse, and medically-refractory cerebral edema.” They add that “AFCE occurs as a rare complication of a variety of common pediatric infections, and a CNS [central nervous system] pathogen is identified in only a minority of cases, suggesting a para-infectious mechanism of edema.”

Neurologists offered a case definition of the “recently recognized” AFCE earlier this year.

“This was an extremely rare rapid progression to cerebral edema. I think it was related to the patient’s COVID infection, but why this patient got it and others don’t is unknown,” Dr. Gershon said in an interview. “The full spectrum of neurological complications of COVID were not yet known [at the time]. We didn’t know, and still don’t know, what the causative links are between COVID and suddenly having seizures and brain swelling.”

He said he’d treat a similar patient differently now and give dexamethasone earlier in the clinical course, although “there is no data to tell us if any therapy could have reversed it.” Specifically, he said, “I’d give dexamethasone at the first sign of brain involvement, using the dosing recommended for cerebral edema, and try to get the MRI earlier in the course.”

Dr. Gershon and colleagues noted another case of fatal cerebral edema in a child, a 7-year-old boy who was treated in New York state. That case “shows that fatal cerebral edema may complicate pediatric multisystem inflammatory syndrome,” they wrote.

Pediatric critical care specialist Preetha Krishnan, MD, of Randall Children’s Hospital at Legacy Emanuel in Portland, Ore., helped develop the new definition of AFCE. In an interview, she said AFCE is difficult to diagnose because the signs/symptoms – such as fever, altered sensorium, and seizures – are found in other conditions such as febrile status epilepticus with a viral illness. 
“The key to recognition of AFCE is that unlike other disease processes, these children have rapid neurologic progression,” she said. “In addition, many of our AFCE patients also had vomiting and/or headache, which in retrospect was likely an indication of elevated ICP [intracranial pressure] rather than viral infection.”
She added that “if a child with fever, seizures, and encephalopathy has cerebral edema on imaging and/or has neurologic progression, AFCE should be considered. Most of our cases of AFCE had fulminant progression within the first 3 days of their head imaging noting cerebral edema. There are other neurologic diseases, such as acute necrotizing encephalopathy of childhood, that also have progressive signs/symptoms, but head imaging and lab work should help differentiate many of these etiologies.”
In regard to treatment, she said, “our unit would likely err on the side of providing as much neuroprotective measures as is reasonable, such as maintaining normothermia, consideration of hyperosmolar therapy, maintaining normocarbia and normoxemia, managing seizures, etc. I would recommend getting the entire neurocritical care team involved in the management discussion. This varies by center, but will likely include neurology, ID [infectious disease], possibly neurosurgery, and PICU.”
As for the new case report, Krishnan said COVID-19 has been linked to neurologic complications, “so it does not surprise me that AFCE is part of the neurologic spectrum of disease.”
No funding was reported, and the authors report no relevant disclosures. Dr. Krishnan has no disclosures.

Medical school clinical rotations are a rite of passage as students emerge from their basic science courses and first board exam to the clinical world where the patients vaguely resemble the question stem descriptions. Finally, intangible theory can be put into practice. Yet, it is becoming increasingly difficult for 3rd-year medical student clerkship directors to find enough clinical sites to support the growing number of medical students as enrollment numbers steadily increase and outpace the current clinical resources.

In a 2019 Association of American Medical Colleges report, 84% of medical school deans were concerned about the diminishing number of clerkship sites, and there was additional worry about lack of qualified specialty preceptors. This lack of clerkship availability is especially true for psychiatry sites.

Psychiatry clerkship directors are in need of more clinical sites to address the educational needs of medical students, and psychiatrists in the broader clinical community are positioned to help medical schools expand their clinical sites.

Inpatient psychiatric units and consult services continue to be popular sites for medical student rotations, but it has been hard to expand into other settings, where psychiatric treatment is seen as more private and intimate than other specialties. Reasons for falling site availability are varied and include 1) financial disincentive to take students – because they can be seen as a burden on supervisors who must meet revenue-generating patient quotas; 2) competition with other learners, including residents, PA students, NPs, and NP students; and 3) the general financial and operational obstacles to clinical practice inflicted by the pandemic. COVID-19 affected medical education – for better and worse (JAMA. 2020;324[11]:1033-4). Psychiatry clerkships particularly suffered from restricted patient access as inpatient units reduced their census to comply with COVID-19 safety protocols, and during the height of the pandemic inpatient units provided psychiatric care to COVID-19–positive patients, which precluded student involvement. On the other hand, many more students were introduced to telepsychiatry and witnessed creative forms of mental health intervention as clinicians adapted their practices to the pandemic.
 

When rotations began

Clinical rotations entered the American medical school curriculum in the 1890s when Sir William Osler brought the European standard of medical education with him as Physician in Chief at the newly opened Johns Hopkins University Hospital. He formalized the traditional apprenticeship model by standardizing 3rd- and 4th-year clerkships as rotations in which medical students worked in clinics and on the wards, learning from residents and attendings.

Clinical rotations, their location, the supervisors, and the patients and their ailments all go in to influence a student’s specialty choice. Some students enter medical school knowing they want to be a surgeon, a pediatrician, or a psychiatrist. And some are compelled by a specific rotation, when they realize that it’s not at all what they expected and maybe they could dedicate their professional life to this area of medicine.

High-quality clinical clerkship sites are essential to the future of psychiatry. At clerkship sites, undecided students interested in psychiatry may affirm their commitment to psychiatry. Other students will have their only dedicated exposure to psychiatrically ill patients. This represents students’ only opportunity to learn the skills to treat comorbid psychiatric and medical illness. Regardless of specialty, nearly every physician will have to treat patients with some psychiatric illnesses.

What constitutes a “high-quality clinical site” is difficult to measure and define. Some measures of quality include a safe learning environment, a reasonable ratio of students to supervisors (including residents, fellows, and attendings), and an adequate number and diversity of patients. Many medical schools may prefer an affiliated academic medical center or Veterans’ Affairs hospitals for their rotating students. Private psychiatric hospitals are proliferating, and if these are to be sites for medical students, the following standards are suggested: Private psychiatric hospitals must follow standard safety precautions with sufficient staff presence, ensure willing preceptors who can provide adequate student supervision, and adjust their expectations to students who can carry a few patients of diverse background, but are not to be treated merely as scribes.

Psychiatrists, whether they consider themselves “academic” or not, have a role to play in expanding access to clinical sites. Students are eager to learn in any setting. Inpatient settings have long been seen as the norm for clinical education in psychiatry. Yet inpatient settings perpetuate the idea that those with severe mental illness or individuals with psychosocial stressors or disabling, comorbid substance use disorders are the only people who seek help from a psychiatrist. This article is a call to action to our colleagues in community mental health centers, managed care settings, and other psychiatric treatment providers without an academic affiliation to explore the possibility of creating space for a medical student in their clinical practice.

We cannot deny the demands on psychiatrists’ time – every minute is counted by the patient and doctor, and every encounter is accounted for in some revenue stream. However, the academic world is running out of space for its students, and there’s a serious question as to whether an academic center is the only place for students. If you are a psychiatrist who still loves to learn and prides themselves on high-quality patient care, then you have an essential role in shaping the students who will one day be your peers in psychiatry, or the physicians treating your patients’ comorbid medical illnesses.

There are upfront challenges to teaching 3rd-year medical students, including teaching the psychiatric interview, note writing, persuading patients to allow students into their care, and setting time aside at the end of the workday to provide feedback on performance. Yet, after learning the ropes of psychiatric patient care, medical students can provide help in writing notes, calling collateral, contacting patients with their laboratory results, and even helping with the tedious but necessary administrative tasks like prior authorizations. In exchange for training students, some medical schools may offer perks, such as a volunteer faculty position that comes with access to usually expensive library resources, such as medical databases.

You can help expand clinical sites in psychiatry rotations by contacting your alma mater or the medical school closest to your community and asking about their need for clerkship sites. Many medical schools are branching out by sending students to stay near the clinical sites and immerse themselves in the community where their site director practices. Even one-half day a week in an outpatient setting provides patient and setting diversity to students and helps spread out students to different sites, easing the burden on inpatient supervisors while providing students more individualized supervision.

The practice of medicine is built on apprenticeship and teaching wisdom through patient care. Just because we leave residency doesn’t mean we leave academics. Taking students into your practice is an invaluable service to the medical education community and future physicians.
 

Dr. Posada is assistant clinical professor in the department of psychiatry and behavioral sciences at George Washington University in Washington, and staff physician at George Washington Medical Faculty Associates, also in Washington. She has no conflicts of interest. Dr. Ortiz is assistant professor and clerkship director in the department of psychiatry at Texas Tech University Health Sciences Center – El Paso. She has no conflicts of interest.

Medical school clinical rotations are a rite of passage as students emerge from their basic science courses and first board exam to the clinical world where the patients vaguely resemble the question stem descriptions. Finally, intangible theory can be put into practice. Yet, it is becoming increasingly difficult for 3rd-year medical student clerkship directors to find enough clinical sites to support the growing number of medical students as enrollment numbers steadily increase and outpace the current clinical resources.

In a 2019 Association of American Medical Colleges report, 84% of medical school deans were concerned about the diminishing number of clerkship sites, and there was additional worry about lack of qualified specialty preceptors. This lack of clerkship availability is especially true for psychiatry sites.

Psychiatry clerkship directors are in need of more clinical sites to address the educational needs of medical students, and psychiatrists in the broader clinical community are positioned to help medical schools expand their clinical sites.

Inpatient psychiatric units and consult services continue to be popular sites for medical student rotations, but it has been hard to expand into other settings, where psychiatric treatment is seen as more private and intimate than other specialties. Reasons for falling site availability are varied and include 1) financial disincentive to take students – because they can be seen as a burden on supervisors who must meet revenue-generating patient quotas; 2) competition with other learners, including residents, PA students, NPs, and NP students; and 3) the general financial and operational obstacles to clinical practice inflicted by the pandemic. COVID-19 affected medical education – for better and worse (JAMA. 2020;324[11]:1033-4). Psychiatry clerkships particularly suffered from restricted patient access as inpatient units reduced their census to comply with COVID-19 safety protocols, and during the height of the pandemic inpatient units provided psychiatric care to COVID-19–positive patients, which precluded student involvement. On the other hand, many more students were introduced to telepsychiatry and witnessed creative forms of mental health intervention as clinicians adapted their practices to the pandemic.
 

When rotations began

Clinical rotations entered the American medical school curriculum in the 1890s when Sir William Osler brought the European standard of medical education with him as Physician in Chief at the newly opened Johns Hopkins University Hospital. He formalized the traditional apprenticeship model by standardizing 3rd- and 4th-year clerkships as rotations in which medical students worked in clinics and on the wards, learning from residents and attendings.

Clinical rotations, their location, the supervisors, and the patients and their ailments all go in to influence a student’s specialty choice. Some students enter medical school knowing they want to be a surgeon, a pediatrician, or a psychiatrist. And some are compelled by a specific rotation, when they realize that it’s not at all what they expected and maybe they could dedicate their professional life to this area of medicine.

High-quality clinical clerkship sites are essential to the future of psychiatry. At clerkship sites, undecided students interested in psychiatry may affirm their commitment to psychiatry. Other students will have their only dedicated exposure to psychiatrically ill patients. This represents students’ only opportunity to learn the skills to treat comorbid psychiatric and medical illness. Regardless of specialty, nearly every physician will have to treat patients with some psychiatric illnesses.

What constitutes a “high-quality clinical site” is difficult to measure and define. Some measures of quality include a safe learning environment, a reasonable ratio of students to supervisors (including residents, fellows, and attendings), and an adequate number and diversity of patients. Many medical schools may prefer an affiliated academic medical center or Veterans’ Affairs hospitals for their rotating students. Private psychiatric hospitals are proliferating, and if these are to be sites for medical students, the following standards are suggested: Private psychiatric hospitals must follow standard safety precautions with sufficient staff presence, ensure willing preceptors who can provide adequate student supervision, and adjust their expectations to students who can carry a few patients of diverse background, but are not to be treated merely as scribes.

Psychiatrists, whether they consider themselves “academic” or not, have a role to play in expanding access to clinical sites. Students are eager to learn in any setting. Inpatient settings have long been seen as the norm for clinical education in psychiatry. Yet inpatient settings perpetuate the idea that those with severe mental illness or individuals with psychosocial stressors or disabling, comorbid substance use disorders are the only people who seek help from a psychiatrist. This article is a call to action to our colleagues in community mental health centers, managed care settings, and other psychiatric treatment providers without an academic affiliation to explore the possibility of creating space for a medical student in their clinical practice.

We cannot deny the demands on psychiatrists’ time – every minute is counted by the patient and doctor, and every encounter is accounted for in some revenue stream. However, the academic world is running out of space for its students, and there’s a serious question as to whether an academic center is the only place for students. If you are a psychiatrist who still loves to learn and prides themselves on high-quality patient care, then you have an essential role in shaping the students who will one day be your peers in psychiatry, or the physicians treating your patients’ comorbid medical illnesses.

There are upfront challenges to teaching 3rd-year medical students, including teaching the psychiatric interview, note writing, persuading patients to allow students into their care, and setting time aside at the end of the workday to provide feedback on performance. Yet, after learning the ropes of psychiatric patient care, medical students can provide help in writing notes, calling collateral, contacting patients with their laboratory results, and even helping with the tedious but necessary administrative tasks like prior authorizations. In exchange for training students, some medical schools may offer perks, such as a volunteer faculty position that comes with access to usually expensive library resources, such as medical databases.

You can help expand clinical sites in psychiatry rotations by contacting your alma mater or the medical school closest to your community and asking about their need for clerkship sites. Many medical schools are branching out by sending students to stay near the clinical sites and immerse themselves in the community where their site director practices. Even one-half day a week in an outpatient setting provides patient and setting diversity to students and helps spread out students to different sites, easing the burden on inpatient supervisors while providing students more individualized supervision.

The practice of medicine is built on apprenticeship and teaching wisdom through patient care. Just because we leave residency doesn’t mean we leave academics. Taking students into your practice is an invaluable service to the medical education community and future physicians.
 

Dr. Posada is assistant clinical professor in the department of psychiatry and behavioral sciences at George Washington University in Washington, and staff physician at George Washington Medical Faculty Associates, also in Washington. She has no conflicts of interest. Dr. Ortiz is assistant professor and clerkship director in the department of psychiatry at Texas Tech University Health Sciences Center – El Paso. She has no conflicts of interest.

Medical school clinical rotations are a rite of passage as students emerge from their basic science courses and first board exam to the clinical world where the patients vaguely resemble the question stem descriptions. Finally, intangible theory can be put into practice. Yet, it is becoming increasingly difficult for 3rd-year medical student clerkship directors to find enough clinical sites to support the growing number of medical students as enrollment numbers steadily increase and outpace the current clinical resources.

In a 2019 Association of American Medical Colleges report, 84% of medical school deans were concerned about the diminishing number of clerkship sites, and there was additional worry about lack of qualified specialty preceptors. This lack of clerkship availability is especially true for psychiatry sites.

Psychiatry clerkship directors are in need of more clinical sites to address the educational needs of medical students, and psychiatrists in the broader clinical community are positioned to help medical schools expand their clinical sites.

Inpatient psychiatric units and consult services continue to be popular sites for medical student rotations, but it has been hard to expand into other settings, where psychiatric treatment is seen as more private and intimate than other specialties. Reasons for falling site availability are varied and include 1) financial disincentive to take students – because they can be seen as a burden on supervisors who must meet revenue-generating patient quotas; 2) competition with other learners, including residents, PA students, NPs, and NP students; and 3) the general financial and operational obstacles to clinical practice inflicted by the pandemic. COVID-19 affected medical education – for better and worse (JAMA. 2020;324[11]:1033-4). Psychiatry clerkships particularly suffered from restricted patient access as inpatient units reduced their census to comply with COVID-19 safety protocols, and during the height of the pandemic inpatient units provided psychiatric care to COVID-19–positive patients, which precluded student involvement. On the other hand, many more students were introduced to telepsychiatry and witnessed creative forms of mental health intervention as clinicians adapted their practices to the pandemic.
 

When rotations began

Clinical rotations entered the American medical school curriculum in the 1890s when Sir William Osler brought the European standard of medical education with him as Physician in Chief at the newly opened Johns Hopkins University Hospital. He formalized the traditional apprenticeship model by standardizing 3rd- and 4th-year clerkships as rotations in which medical students worked in clinics and on the wards, learning from residents and attendings.

Clinical rotations, their location, the supervisors, and the patients and their ailments all go in to influence a student’s specialty choice. Some students enter medical school knowing they want to be a surgeon, a pediatrician, or a psychiatrist. And some are compelled by a specific rotation, when they realize that it’s not at all what they expected and maybe they could dedicate their professional life to this area of medicine.

High-quality clinical clerkship sites are essential to the future of psychiatry. At clerkship sites, undecided students interested in psychiatry may affirm their commitment to psychiatry. Other students will have their only dedicated exposure to psychiatrically ill patients. This represents students’ only opportunity to learn the skills to treat comorbid psychiatric and medical illness. Regardless of specialty, nearly every physician will have to treat patients with some psychiatric illnesses.

What constitutes a “high-quality clinical site” is difficult to measure and define. Some measures of quality include a safe learning environment, a reasonable ratio of students to supervisors (including residents, fellows, and attendings), and an adequate number and diversity of patients. Many medical schools may prefer an affiliated academic medical center or Veterans’ Affairs hospitals for their rotating students. Private psychiatric hospitals are proliferating, and if these are to be sites for medical students, the following standards are suggested: Private psychiatric hospitals must follow standard safety precautions with sufficient staff presence, ensure willing preceptors who can provide adequate student supervision, and adjust their expectations to students who can carry a few patients of diverse background, but are not to be treated merely as scribes.

Psychiatrists, whether they consider themselves “academic” or not, have a role to play in expanding access to clinical sites. Students are eager to learn in any setting. Inpatient settings have long been seen as the norm for clinical education in psychiatry. Yet inpatient settings perpetuate the idea that those with severe mental illness or individuals with psychosocial stressors or disabling, comorbid substance use disorders are the only people who seek help from a psychiatrist. This article is a call to action to our colleagues in community mental health centers, managed care settings, and other psychiatric treatment providers without an academic affiliation to explore the possibility of creating space for a medical student in their clinical practice.

We cannot deny the demands on psychiatrists’ time – every minute is counted by the patient and doctor, and every encounter is accounted for in some revenue stream. However, the academic world is running out of space for its students, and there’s a serious question as to whether an academic center is the only place for students. If you are a psychiatrist who still loves to learn and prides themselves on high-quality patient care, then you have an essential role in shaping the students who will one day be your peers in psychiatry, or the physicians treating your patients’ comorbid medical illnesses.

There are upfront challenges to teaching 3rd-year medical students, including teaching the psychiatric interview, note writing, persuading patients to allow students into their care, and setting time aside at the end of the workday to provide feedback on performance. Yet, after learning the ropes of psychiatric patient care, medical students can provide help in writing notes, calling collateral, contacting patients with their laboratory results, and even helping with the tedious but necessary administrative tasks like prior authorizations. In exchange for training students, some medical schools may offer perks, such as a volunteer faculty position that comes with access to usually expensive library resources, such as medical databases.

You can help expand clinical sites in psychiatry rotations by contacting your alma mater or the medical school closest to your community and asking about their need for clerkship sites. Many medical schools are branching out by sending students to stay near the clinical sites and immerse themselves in the community where their site director practices. Even one-half day a week in an outpatient setting provides patient and setting diversity to students and helps spread out students to different sites, easing the burden on inpatient supervisors while providing students more individualized supervision.

The practice of medicine is built on apprenticeship and teaching wisdom through patient care. Just because we leave residency doesn’t mean we leave academics. Taking students into your practice is an invaluable service to the medical education community and future physicians.
 

Dr. Posada is assistant clinical professor in the department of psychiatry and behavioral sciences at George Washington University in Washington, and staff physician at George Washington Medical Faculty Associates, also in Washington. She has no conflicts of interest. Dr. Ortiz is assistant professor and clerkship director in the department of psychiatry at Texas Tech University Health Sciences Center – El Paso. She has no conflicts of interest.