Pediatrics

MONTREAL – Ocular surface disease (OSD) in patients with atopic dermatitis (AD) treated with dupilumab may be exacerbated rather than caused by the therapy, according to a study presented at the annual meeting of the International Society of Atopic Dermatitis.

In a prospective trial of 69 patients with AD starting dupilumab (Dupixent), baseline OSD was found in 91.3%, with about half of these patients reporting no symptoms, said investigator Roselie Achten, MD, from the National Expertise Center for Atopic Dermatitis at University Medical Center Utrecht, the Netherlands. Among these patients, ophthalmologic assessment revealed no OSD in 6 patients and mild OSD in 37 patients, but moderate and severe disease in 20 and 6 patients, respectively, she said, adding that 71% of the group also reported allergic conjunctivitis at baseline.

The patients enrolled in the study who started dupilumab were aged 36-38 years, with Eczema Area and Severity Index (EASI) scores of 14.7-16.5. Baseline ocular surface health was assessed with the Utrecht Ophthalmic Inflammatory and Allergic disease (UTOPIA) score. Tear fluid was collected to analyze biomarkers and dupilumab levels, and impression cytology was performed to collect conjunctival tissue cells for analysis of goblet cells. These measurements were repeated at 4 and 28 weeks after the start of therapy.

Over 28 weeks of treatment, 14.5% of patients experienced worsening of OSD, with worsening disease associated with a decline in the number of goblet cells. In addition, dupilumab treatment was associated with a significant decline in the production of Mucin5AC, suggesting a decline in function of the goblet cells. “Our hypothesis that the blocking effect of dupilumab on [interleukin-] IL-13 might lead to less goblet cells and less mucin production,” she explained.

In a subset of 48 patients, the researchers also detected significantly higher tear fluid dupilumab levels among those patients with more severe OSD, with comparable serum levels.

OSD has been reported in up to 34% of dupilumab-treated patients with AD and is the most frequently reported side-effect of this treatment, noted Dr. Achten. This side effect is not reported by other patients treated with dupilumab for other indications, she added, “suggesting that AD patients may have a predisposition to develop OSD during dupilumab treatment.”

Indeed, as recently noted by Vivian Shi, MD, from the department of dermatology, University of Arkansas for Medical Sciences, Little Rock, and colleagues, “for reasons not well understood, the incidence of conjunctivitis in dupilumab patients with asthma (0%-2.3%), chronic rhinosinusitis with nasal polyps (1.6%), or eosinophilic esophagitis (0%) is low to none; thus, patients with AD may be particularly susceptible.”

Dr. Achten said that dupilumab-treated patients with AD at her center are prescribed topical tacrolimus and ketotifen eye drops if they develop OSD.

Asked for comment, Melinda Gooderham, MD, who moderated the session, was impressed with the study. “I’d heard about the goblet cells, there were little bits of data here and there, but the tear analysis is something I hadn’t seen before. It was a nice series of experiments that pulled everything together,” she told this news organization. Dr. Gooderham, who is assistant professor at Queens University, in Kingston, Ontario, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, and consultant physician at Peterborough Regional Health Centre, said that she first began noticing dupilumab-related OSD as an early trial investigator for the drug. “When you put some patients on the drug it’s almost like tipping the balance – that little bit of mucin they’re dependent on is now reduced and it makes them more symptomatic,” she said.

Though she prescribes lubricating eye drops as prophylaxis for all her dupilumab-treated patients with AD, she recommends referring any patients who develop OSD to an ophthalmologist who is familiar with this specific side effect. “If they just see a random ophthalmologist who doesn’t know dupilumab, and doesn’t know the story around it, they could get any sort of diagnosis, or even be told to stop the medication altogether.”

The study was sponsored by Sanofi. Dr. Achten disclosed no other conflicts of interest. Dr. Gooderham is an investigator with Sanofi Genzyme for dupilumab.

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

MONTREAL – Ocular surface disease (OSD) in patients with atopic dermatitis (AD) treated with dupilumab may be exacerbated rather than caused by the therapy, according to a study presented at the annual meeting of the International Society of Atopic Dermatitis.

In a prospective trial of 69 patients with AD starting dupilumab (Dupixent), baseline OSD was found in 91.3%, with about half of these patients reporting no symptoms, said investigator Roselie Achten, MD, from the National Expertise Center for Atopic Dermatitis at University Medical Center Utrecht, the Netherlands. Among these patients, ophthalmologic assessment revealed no OSD in 6 patients and mild OSD in 37 patients, but moderate and severe disease in 20 and 6 patients, respectively, she said, adding that 71% of the group also reported allergic conjunctivitis at baseline.

The patients enrolled in the study who started dupilumab were aged 36-38 years, with Eczema Area and Severity Index (EASI) scores of 14.7-16.5. Baseline ocular surface health was assessed with the Utrecht Ophthalmic Inflammatory and Allergic disease (UTOPIA) score. Tear fluid was collected to analyze biomarkers and dupilumab levels, and impression cytology was performed to collect conjunctival tissue cells for analysis of goblet cells. These measurements were repeated at 4 and 28 weeks after the start of therapy.

Over 28 weeks of treatment, 14.5% of patients experienced worsening of OSD, with worsening disease associated with a decline in the number of goblet cells. In addition, dupilumab treatment was associated with a significant decline in the production of Mucin5AC, suggesting a decline in function of the goblet cells. “Our hypothesis that the blocking effect of dupilumab on [interleukin-] IL-13 might lead to less goblet cells and less mucin production,” she explained.

In a subset of 48 patients, the researchers also detected significantly higher tear fluid dupilumab levels among those patients with more severe OSD, with comparable serum levels.

OSD has been reported in up to 34% of dupilumab-treated patients with AD and is the most frequently reported side-effect of this treatment, noted Dr. Achten. This side effect is not reported by other patients treated with dupilumab for other indications, she added, “suggesting that AD patients may have a predisposition to develop OSD during dupilumab treatment.”

Indeed, as recently noted by Vivian Shi, MD, from the department of dermatology, University of Arkansas for Medical Sciences, Little Rock, and colleagues, “for reasons not well understood, the incidence of conjunctivitis in dupilumab patients with asthma (0%-2.3%), chronic rhinosinusitis with nasal polyps (1.6%), or eosinophilic esophagitis (0%) is low to none; thus, patients with AD may be particularly susceptible.”

Dr. Achten said that dupilumab-treated patients with AD at her center are prescribed topical tacrolimus and ketotifen eye drops if they develop OSD.

Asked for comment, Melinda Gooderham, MD, who moderated the session, was impressed with the study. “I’d heard about the goblet cells, there were little bits of data here and there, but the tear analysis is something I hadn’t seen before. It was a nice series of experiments that pulled everything together,” she told this news organization. Dr. Gooderham, who is assistant professor at Queens University, in Kingston, Ontario, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, and consultant physician at Peterborough Regional Health Centre, said that she first began noticing dupilumab-related OSD as an early trial investigator for the drug. “When you put some patients on the drug it’s almost like tipping the balance – that little bit of mucin they’re dependent on is now reduced and it makes them more symptomatic,” she said.

Though she prescribes lubricating eye drops as prophylaxis for all her dupilumab-treated patients with AD, she recommends referring any patients who develop OSD to an ophthalmologist who is familiar with this specific side effect. “If they just see a random ophthalmologist who doesn’t know dupilumab, and doesn’t know the story around it, they could get any sort of diagnosis, or even be told to stop the medication altogether.”

The study was sponsored by Sanofi. Dr. Achten disclosed no other conflicts of interest. Dr. Gooderham is an investigator with Sanofi Genzyme for dupilumab.

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

MONTREAL – Ocular surface disease (OSD) in patients with atopic dermatitis (AD) treated with dupilumab may be exacerbated rather than caused by the therapy, according to a study presented at the annual meeting of the International Society of Atopic Dermatitis.

In a prospective trial of 69 patients with AD starting dupilumab (Dupixent), baseline OSD was found in 91.3%, with about half of these patients reporting no symptoms, said investigator Roselie Achten, MD, from the National Expertise Center for Atopic Dermatitis at University Medical Center Utrecht, the Netherlands. Among these patients, ophthalmologic assessment revealed no OSD in 6 patients and mild OSD in 37 patients, but moderate and severe disease in 20 and 6 patients, respectively, she said, adding that 71% of the group also reported allergic conjunctivitis at baseline.

The patients enrolled in the study who started dupilumab were aged 36-38 years, with Eczema Area and Severity Index (EASI) scores of 14.7-16.5. Baseline ocular surface health was assessed with the Utrecht Ophthalmic Inflammatory and Allergic disease (UTOPIA) score. Tear fluid was collected to analyze biomarkers and dupilumab levels, and impression cytology was performed to collect conjunctival tissue cells for analysis of goblet cells. These measurements were repeated at 4 and 28 weeks after the start of therapy.

Over 28 weeks of treatment, 14.5% of patients experienced worsening of OSD, with worsening disease associated with a decline in the number of goblet cells. In addition, dupilumab treatment was associated with a significant decline in the production of Mucin5AC, suggesting a decline in function of the goblet cells. “Our hypothesis that the blocking effect of dupilumab on [interleukin-] IL-13 might lead to less goblet cells and less mucin production,” she explained.

In a subset of 48 patients, the researchers also detected significantly higher tear fluid dupilumab levels among those patients with more severe OSD, with comparable serum levels.

OSD has been reported in up to 34% of dupilumab-treated patients with AD and is the most frequently reported side-effect of this treatment, noted Dr. Achten. This side effect is not reported by other patients treated with dupilumab for other indications, she added, “suggesting that AD patients may have a predisposition to develop OSD during dupilumab treatment.”

Indeed, as recently noted by Vivian Shi, MD, from the department of dermatology, University of Arkansas for Medical Sciences, Little Rock, and colleagues, “for reasons not well understood, the incidence of conjunctivitis in dupilumab patients with asthma (0%-2.3%), chronic rhinosinusitis with nasal polyps (1.6%), or eosinophilic esophagitis (0%) is low to none; thus, patients with AD may be particularly susceptible.”

Dr. Achten said that dupilumab-treated patients with AD at her center are prescribed topical tacrolimus and ketotifen eye drops if they develop OSD.

Asked for comment, Melinda Gooderham, MD, who moderated the session, was impressed with the study. “I’d heard about the goblet cells, there were little bits of data here and there, but the tear analysis is something I hadn’t seen before. It was a nice series of experiments that pulled everything together,” she told this news organization. Dr. Gooderham, who is assistant professor at Queens University, in Kingston, Ontario, medical director at the SKiN Centre for Dermatology in Peterborough, Ontario, and consultant physician at Peterborough Regional Health Centre, said that she first began noticing dupilumab-related OSD as an early trial investigator for the drug. “When you put some patients on the drug it’s almost like tipping the balance – that little bit of mucin they’re dependent on is now reduced and it makes them more symptomatic,” she said.

Though she prescribes lubricating eye drops as prophylaxis for all her dupilumab-treated patients with AD, she recommends referring any patients who develop OSD to an ophthalmologist who is familiar with this specific side effect. “If they just see a random ophthalmologist who doesn’t know dupilumab, and doesn’t know the story around it, they could get any sort of diagnosis, or even be told to stop the medication altogether.”

The study was sponsored by Sanofi. Dr. Achten disclosed no other conflicts of interest. Dr. Gooderham is an investigator with Sanofi Genzyme for dupilumab.

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

Words including death, die, dying, or stillborn were frequently replaced by euphemisms in meetings between clinicians and families of critically ill children, based on data from 33 family meetings that involved discussions of death.

Clear communication is essential in discussing death with patients and families and current consensus guidelines recommend against use of euphemisms; data also suggest that patients and families prefer clear and direct language, wrote Margaret H. Barlet, of Duke University, Durham, N.C., and colleagues.

However, data on the language used in discussions of death in neonatal or pediatric contexts are limited, they said.

In a study published in JAMA Network Open, the researchers reviewed conversations between clinicians and parents of critically ill children. The study participants included 20 parents of 13 infants with neurological conditions who were hospitalized in a pediatric ICU in a single center in the southeastern United States between September 2018 and September 2020. Family meetings were scheduled to discuss prognosis and whether to start, not start, or discontinue life-sustaining treatment. The discussions were recorded, transcribed, and deidentified. The median age of the parents was 28.5 years; 60% identified as Black, 40% as White, and 10% as Asian; with some selecting more than one race.

For all 13 infants, one parent identified as the infant’s mother, and another parent identified as the father for seven of the infants. The median gestational age of the infants was 37 weeks; 54% were female, and the median hospital stay was 86 days.

Twelve infants (92%) required mechanical ventilation, six required chest compressions, and five had a do-not-attempt resuscitation order placed. Two infants died during the hospital admission process.

The primary outcome of the study was language used to reference death during family meetings between doctors and families. In the family conversations, death was referenced 406 times (275 times by clinicians and 131 times by family members).

Families were more likely than were clinicians to use the words die, death, dying, or stillborn; these terms appeared in 19 of 131 references by families and 13 of 275 references by clinicians (15% vs. 5%).

In addition to a category for use of words such as die, death, dying, or stillborn, the researchers identified four types of euphemisms used in place of these terms. They characterized the types of euphemisms as survival framing (for example, not live), colloquialisms (for example, pass away), medical jargon or use of physiologic terms (for example, code event or irrecoverable heart rate drop) and the use of pronouns without an antecedent (for example, it might happen soon).

Overall, 92% of references to death in the conversations were euphemistic. Medical jargon was the most common type of euphemism used by clinicians (118 of 275 references, 43%), while colloquialism was the most common type used by family members (44 of 131 references, 34%).

The results are consistent with limited research on this topic and show the high rates of euphemistic language used in discussions of death, the researchers wrote in their discussion. “Although our work did not directly evaluate the comparative clarity of different ways to reference death, our results raise questions about what language is most clear,” they said. The researchers proposed that their classification of euphemistic language may provide a framework for the use of language in discussions of death and may prompt clinicians to notice the language they use and hear from patients and families. “Empirically evaluating the perceived clarity of euphemism types and their effects on shared decision-making should be a priority for future study and should be used to inform interventions for improving communication in this context,” they said.

The findings were limited by several factors including the use of data from a single institution and the exclusion of non-English speaking families, the researchers noted. In addition, the researchers studied only what was said, therefore “questions about speaker motivation, listener understanding, and the effects of language choice on decision-making remain unanswered,” they added.

However, the results reflect the frequent use of euphemisms by both clinicians and families, and more research is needed to assess the effect of language on understanding, decision-making, and doctor-patient relationships, the researchers concluded.
 

Euphemisms can create confusion but may increase empathy

“Ms. Barlet and colleagues provide further consideration of types of speech that may obscure a clinician’s intended meaning or distract from their true point in the context of family discussions about critically ill patients,” Michael B. Pitt, MD, of the University of Minnesota, Minneapolis, and colleagues wrote in an accompanying editorial. Using a euphemism such as “pass on” instead of “die” may be an intentional choice by physicians to use less harsh language but it may still cause confusion, they noted.

The study showed how frequently physicians use euphemisms to talk about death but was distinctive in the inclusion of data on language use by families as well, they said.

“This pattern of use identified among the infants’ families may indicate that despite the clinical recommendation that end-of-life discussions avoid the use of euphemisms, it may be worth noting and responding to families’ language preferences accordingly once it is clear they have expressed understanding that the clinician is speaking of death,” they said. For example, if a family is consistently using softer terminology, clinicians should consider responding with similar terms, rather than using medical jargon or the words death or dying, they wrote.

“As the authors note, family preferences for this type of discussion are an important target for future research aimed at optimizing family-centered communication,” the editorialists added.
 

Families seek clarity in communication

“Clinicians have an important role in helping parents of seriously ill children understand their child’s health condition and make value-driven decisions about care,” Jennifer W. Mack, MD, of Harvard Medical School and the Dana-Farber Cancer Institute, Boston, said in an interview. “The words that clinicians use can have a significant impact on the knowledge parents take away from encounters and the decisions they make. While there is evidence of euphemistic language in the adult setting, there is limited information about this in children,” said Dr. Mack, a pediatric hematologist/oncologist who was not involved in the study.

Dr. Mack said she was not entirely surprised that in the current study, clinician language often includes medical jargon and an avoidance of direct language about death. “This is consistent with what I have seen in clinical practice,” she said. “One striking aspect of the study is that parents used terms like death or die more often than clinicians, and they sometimes used these terms as a way to clarify what the clinician was saying. This suggests to me that parents often want clarity, even if the information is very difficult,” she said.

The key message of the study is that clinicians should pay attention to the words they use to talk about the possibility of death and recognize the tendency of many clinicians to fall back on medical jargon, said Dr. Mack.

“My personal belief is that it is possible to be both clear and compassionate, and clinicians should strive for both in these conversations, to support families and help them make their best decisions for their children,” she said. “We need to remember a single communication strategy or choice of words is not likely to feel supportive to every family; what is helpful for one family may feel painful to another,” she emphasized. “Being willing to listen to the needs they express and their own language choice can help us to be responsive to individual needs,” she added.

An important next step for research is to learn more about what families experience as supportive during conversations with clinicians about death and dying, Dr. Mack said.

The study was supported by the National Institute of Neurological Disorders and Stroke, National Institutes of Health, and the Doris Duke Charitable Foundation. The researchers, editorial authors, and Dr. Mack had no financial conflicts to disclose.

Words including death, die, dying, or stillborn were frequently replaced by euphemisms in meetings between clinicians and families of critically ill children, based on data from 33 family meetings that involved discussions of death.

Clear communication is essential in discussing death with patients and families and current consensus guidelines recommend against use of euphemisms; data also suggest that patients and families prefer clear and direct language, wrote Margaret H. Barlet, of Duke University, Durham, N.C., and colleagues.

However, data on the language used in discussions of death in neonatal or pediatric contexts are limited, they said.

In a study published in JAMA Network Open, the researchers reviewed conversations between clinicians and parents of critically ill children. The study participants included 20 parents of 13 infants with neurological conditions who were hospitalized in a pediatric ICU in a single center in the southeastern United States between September 2018 and September 2020. Family meetings were scheduled to discuss prognosis and whether to start, not start, or discontinue life-sustaining treatment. The discussions were recorded, transcribed, and deidentified. The median age of the parents was 28.5 years; 60% identified as Black, 40% as White, and 10% as Asian; with some selecting more than one race.

For all 13 infants, one parent identified as the infant’s mother, and another parent identified as the father for seven of the infants. The median gestational age of the infants was 37 weeks; 54% were female, and the median hospital stay was 86 days.

Twelve infants (92%) required mechanical ventilation, six required chest compressions, and five had a do-not-attempt resuscitation order placed. Two infants died during the hospital admission process.

The primary outcome of the study was language used to reference death during family meetings between doctors and families. In the family conversations, death was referenced 406 times (275 times by clinicians and 131 times by family members).

Families were more likely than were clinicians to use the words die, death, dying, or stillborn; these terms appeared in 19 of 131 references by families and 13 of 275 references by clinicians (15% vs. 5%).

In addition to a category for use of words such as die, death, dying, or stillborn, the researchers identified four types of euphemisms used in place of these terms. They characterized the types of euphemisms as survival framing (for example, not live), colloquialisms (for example, pass away), medical jargon or use of physiologic terms (for example, code event or irrecoverable heart rate drop) and the use of pronouns without an antecedent (for example, it might happen soon).

Overall, 92% of references to death in the conversations were euphemistic. Medical jargon was the most common type of euphemism used by clinicians (118 of 275 references, 43%), while colloquialism was the most common type used by family members (44 of 131 references, 34%).

The results are consistent with limited research on this topic and show the high rates of euphemistic language used in discussions of death, the researchers wrote in their discussion. “Although our work did not directly evaluate the comparative clarity of different ways to reference death, our results raise questions about what language is most clear,” they said. The researchers proposed that their classification of euphemistic language may provide a framework for the use of language in discussions of death and may prompt clinicians to notice the language they use and hear from patients and families. “Empirically evaluating the perceived clarity of euphemism types and their effects on shared decision-making should be a priority for future study and should be used to inform interventions for improving communication in this context,” they said.

The findings were limited by several factors including the use of data from a single institution and the exclusion of non-English speaking families, the researchers noted. In addition, the researchers studied only what was said, therefore “questions about speaker motivation, listener understanding, and the effects of language choice on decision-making remain unanswered,” they added.

However, the results reflect the frequent use of euphemisms by both clinicians and families, and more research is needed to assess the effect of language on understanding, decision-making, and doctor-patient relationships, the researchers concluded.
 

Euphemisms can create confusion but may increase empathy

“Ms. Barlet and colleagues provide further consideration of types of speech that may obscure a clinician’s intended meaning or distract from their true point in the context of family discussions about critically ill patients,” Michael B. Pitt, MD, of the University of Minnesota, Minneapolis, and colleagues wrote in an accompanying editorial. Using a euphemism such as “pass on” instead of “die” may be an intentional choice by physicians to use less harsh language but it may still cause confusion, they noted.

The study showed how frequently physicians use euphemisms to talk about death but was distinctive in the inclusion of data on language use by families as well, they said.

“This pattern of use identified among the infants’ families may indicate that despite the clinical recommendation that end-of-life discussions avoid the use of euphemisms, it may be worth noting and responding to families’ language preferences accordingly once it is clear they have expressed understanding that the clinician is speaking of death,” they said. For example, if a family is consistently using softer terminology, clinicians should consider responding with similar terms, rather than using medical jargon or the words death or dying, they wrote.

“As the authors note, family preferences for this type of discussion are an important target for future research aimed at optimizing family-centered communication,” the editorialists added.
 

Families seek clarity in communication

“Clinicians have an important role in helping parents of seriously ill children understand their child’s health condition and make value-driven decisions about care,” Jennifer W. Mack, MD, of Harvard Medical School and the Dana-Farber Cancer Institute, Boston, said in an interview. “The words that clinicians use can have a significant impact on the knowledge parents take away from encounters and the decisions they make. While there is evidence of euphemistic language in the adult setting, there is limited information about this in children,” said Dr. Mack, a pediatric hematologist/oncologist who was not involved in the study.

Dr. Mack said she was not entirely surprised that in the current study, clinician language often includes medical jargon and an avoidance of direct language about death. “This is consistent with what I have seen in clinical practice,” she said. “One striking aspect of the study is that parents used terms like death or die more often than clinicians, and they sometimes used these terms as a way to clarify what the clinician was saying. This suggests to me that parents often want clarity, even if the information is very difficult,” she said.

The key message of the study is that clinicians should pay attention to the words they use to talk about the possibility of death and recognize the tendency of many clinicians to fall back on medical jargon, said Dr. Mack.

“My personal belief is that it is possible to be both clear and compassionate, and clinicians should strive for both in these conversations, to support families and help them make their best decisions for their children,” she said. “We need to remember a single communication strategy or choice of words is not likely to feel supportive to every family; what is helpful for one family may feel painful to another,” she emphasized. “Being willing to listen to the needs they express and their own language choice can help us to be responsive to individual needs,” she added.

An important next step for research is to learn more about what families experience as supportive during conversations with clinicians about death and dying, Dr. Mack said.

The study was supported by the National Institute of Neurological Disorders and Stroke, National Institutes of Health, and the Doris Duke Charitable Foundation. The researchers, editorial authors, and Dr. Mack had no financial conflicts to disclose.

Words including death, die, dying, or stillborn were frequently replaced by euphemisms in meetings between clinicians and families of critically ill children, based on data from 33 family meetings that involved discussions of death.

Clear communication is essential in discussing death with patients and families and current consensus guidelines recommend against use of euphemisms; data also suggest that patients and families prefer clear and direct language, wrote Margaret H. Barlet, of Duke University, Durham, N.C., and colleagues.

However, data on the language used in discussions of death in neonatal or pediatric contexts are limited, they said.

In a study published in JAMA Network Open, the researchers reviewed conversations between clinicians and parents of critically ill children. The study participants included 20 parents of 13 infants with neurological conditions who were hospitalized in a pediatric ICU in a single center in the southeastern United States between September 2018 and September 2020. Family meetings were scheduled to discuss prognosis and whether to start, not start, or discontinue life-sustaining treatment. The discussions were recorded, transcribed, and deidentified. The median age of the parents was 28.5 years; 60% identified as Black, 40% as White, and 10% as Asian; with some selecting more than one race.

For all 13 infants, one parent identified as the infant’s mother, and another parent identified as the father for seven of the infants. The median gestational age of the infants was 37 weeks; 54% were female, and the median hospital stay was 86 days.

Twelve infants (92%) required mechanical ventilation, six required chest compressions, and five had a do-not-attempt resuscitation order placed. Two infants died during the hospital admission process.

The primary outcome of the study was language used to reference death during family meetings between doctors and families. In the family conversations, death was referenced 406 times (275 times by clinicians and 131 times by family members).

Families were more likely than were clinicians to use the words die, death, dying, or stillborn; these terms appeared in 19 of 131 references by families and 13 of 275 references by clinicians (15% vs. 5%).

In addition to a category for use of words such as die, death, dying, or stillborn, the researchers identified four types of euphemisms used in place of these terms. They characterized the types of euphemisms as survival framing (for example, not live), colloquialisms (for example, pass away), medical jargon or use of physiologic terms (for example, code event or irrecoverable heart rate drop) and the use of pronouns without an antecedent (for example, it might happen soon).

Overall, 92% of references to death in the conversations were euphemistic. Medical jargon was the most common type of euphemism used by clinicians (118 of 275 references, 43%), while colloquialism was the most common type used by family members (44 of 131 references, 34%).

The results are consistent with limited research on this topic and show the high rates of euphemistic language used in discussions of death, the researchers wrote in their discussion. “Although our work did not directly evaluate the comparative clarity of different ways to reference death, our results raise questions about what language is most clear,” they said. The researchers proposed that their classification of euphemistic language may provide a framework for the use of language in discussions of death and may prompt clinicians to notice the language they use and hear from patients and families. “Empirically evaluating the perceived clarity of euphemism types and their effects on shared decision-making should be a priority for future study and should be used to inform interventions for improving communication in this context,” they said.

The findings were limited by several factors including the use of data from a single institution and the exclusion of non-English speaking families, the researchers noted. In addition, the researchers studied only what was said, therefore “questions about speaker motivation, listener understanding, and the effects of language choice on decision-making remain unanswered,” they added.

However, the results reflect the frequent use of euphemisms by both clinicians and families, and more research is needed to assess the effect of language on understanding, decision-making, and doctor-patient relationships, the researchers concluded.
 

Euphemisms can create confusion but may increase empathy

“Ms. Barlet and colleagues provide further consideration of types of speech that may obscure a clinician’s intended meaning or distract from their true point in the context of family discussions about critically ill patients,” Michael B. Pitt, MD, of the University of Minnesota, Minneapolis, and colleagues wrote in an accompanying editorial. Using a euphemism such as “pass on” instead of “die” may be an intentional choice by physicians to use less harsh language but it may still cause confusion, they noted.

The study showed how frequently physicians use euphemisms to talk about death but was distinctive in the inclusion of data on language use by families as well, they said.

“This pattern of use identified among the infants’ families may indicate that despite the clinical recommendation that end-of-life discussions avoid the use of euphemisms, it may be worth noting and responding to families’ language preferences accordingly once it is clear they have expressed understanding that the clinician is speaking of death,” they said. For example, if a family is consistently using softer terminology, clinicians should consider responding with similar terms, rather than using medical jargon or the words death or dying, they wrote.

“As the authors note, family preferences for this type of discussion are an important target for future research aimed at optimizing family-centered communication,” the editorialists added.
 

Families seek clarity in communication

“Clinicians have an important role in helping parents of seriously ill children understand their child’s health condition and make value-driven decisions about care,” Jennifer W. Mack, MD, of Harvard Medical School and the Dana-Farber Cancer Institute, Boston, said in an interview. “The words that clinicians use can have a significant impact on the knowledge parents take away from encounters and the decisions they make. While there is evidence of euphemistic language in the adult setting, there is limited information about this in children,” said Dr. Mack, a pediatric hematologist/oncologist who was not involved in the study.

Dr. Mack said she was not entirely surprised that in the current study, clinician language often includes medical jargon and an avoidance of direct language about death. “This is consistent with what I have seen in clinical practice,” she said. “One striking aspect of the study is that parents used terms like death or die more often than clinicians, and they sometimes used these terms as a way to clarify what the clinician was saying. This suggests to me that parents often want clarity, even if the information is very difficult,” she said.

The key message of the study is that clinicians should pay attention to the words they use to talk about the possibility of death and recognize the tendency of many clinicians to fall back on medical jargon, said Dr. Mack.

“My personal belief is that it is possible to be both clear and compassionate, and clinicians should strive for both in these conversations, to support families and help them make their best decisions for their children,” she said. “We need to remember a single communication strategy or choice of words is not likely to feel supportive to every family; what is helpful for one family may feel painful to another,” she emphasized. “Being willing to listen to the needs they express and their own language choice can help us to be responsive to individual needs,” she added.

An important next step for research is to learn more about what families experience as supportive during conversations with clinicians about death and dying, Dr. Mack said.

The study was supported by the National Institute of Neurological Disorders and Stroke, National Institutes of Health, and the Doris Duke Charitable Foundation. The researchers, editorial authors, and Dr. Mack had no financial conflicts to disclose.

CINCINNATI – Neurology and psychiatry have an inherent kinship, as one often deals with the brain and the other always focuses on the mind. The two fields can be intertwined, since neurological conditions are often associated with psychiatric comorbidities amid complex relationships: For example, a young patient with a neurological disorder may experience anxiety due to life changes, his or her diagnosis, or altered biological pathways from the condition or medications used to treat it.

As a result, psychiatric comorbidities are often seen among pediatric patients with neurological conditions, and pediatric neurologists can play an important role in diagnosis and management of such disorders, according to Devin McNulty, PhD, who spoke on the topic at the 2022 annual meeting of the Child Neurology Society.
 

The ‘second pandemic’

Mental health conditions represent about 16% of the global burden of disease among people aged 10-19, and the COVID-19 pandemic has drastically worsened the problem, as shutdowns, school loss, and economic struggles have added to the burden. “I think we’ve really seen mental health as sort of the second pandemic. We’ve seen this in Chicago in our emergency room, and in outpatient clinics wait-lists are really high. I think adolescents are specifically at risk,” said Dr. McNulty during her talk. She is an assistant professor of psychiatry and behavioral sciences at Northwestern University and a child psychiatrist at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Common diagnoses include major depressive order, social anxiety disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, somatic symptom disorder, and functional neurological symptom disorder. The last can appear as neurological symptoms that are not consistent with neurological medical conditions, such as attacks or seizures, abnormal movements, sensory loss or gain, weakness or paralysis, or speech and swallowing issues. It is the second most commonly diagnosed disorder in neurology clinics and accounts for 10% of neurology hospitalizations, and it leads to high rates of health care utilization and functional impairment.

Overall, children with neurological conditions are at about a 5-fold increased risk for depression and anxiety disorders, with a range of contributing risk factors. These include biological factors like medication use, neurological dysfunction, and genetic vulnerability. Psychological factors include stressors, the child’s reaction to the diagnosis and illness, and the level of his or her coping skills. Psychiatric comorbidities may also be triggered by social factors such as familial stress, peer rejection and social isolation, and barriers to treatment for the neurological condition. As just one example, overprotective parenting behavior, while adaptive in moderation, can create a sort of feedback loop that can lead to separation anxiety.
 

A unique opportunity

“There’s an overlap,” Dr. McNulty said, “because the origin is often multifactorial.” A young patient has a medical condition, which can be chronic or disabling, and the age of onset and diagnosis comes during a critical developmental period. “Then we have issues such as the impact of treatments, whether that’s medication side effects or medical visits. And then disease-related environmental changes, such as family factors, social changes, and impact on school,” said Dr. McNulty.

Child neurologists are in a unique position to identify and ensure treatment of these psychiatric comorbidities, according to Dr. McNulty. “Child neurologists will see psychiatric symptoms in their patient population, and pediatric providers have a unique capacity and ability to treat these patients, especially when you’re seeing patients on a frequent basis. You get to know these patients and their families really well,” she said.

She specifically pointed to three areas: psychosocial screening, differential diagnosis, and treatment and management.

There are broad-based screening measures that can be useful, such as the Strengths and Difficulties Questionnaire and the Pediatric Symptom Checklist. Disorder-specific screening tools include the PHQ-9 (depression), GAD7 (anxiety), Vanderbilt (ADHD), and PROMIS measures for anxiety and depression. “The idea behind the screening measure is that all patients would fill this out and then if a patient screens positive, they would benefit from a more thorough evaluation and history,” said Dr. McNulty.

However, she noted that screening shouldn’t necessarily be a one-off effort. Research has shown that sequential screening is the most powerful strategy. “Then you can get a baseline of a patient’s emotional and behavioral functioning, and it’s actually the changes in some of these screening measures that might give them most clinical information,” said Dr. McNulty.

In fact, on October 11, 2022, the U.S. Preventive Services Task Force announced a recommendation that all children starting at age 8 should be screened for anxiety disorders. It is already recommended to screen children aged 12 and over for depressive disorders, although these documents are aimed primarily at pediatricians or primary care clinics. The American Academy of Neurology has also recommended routine screening of psychiatric and behavioral disorders among children with epilepsy.
 

A unique perspective

Once a disorder is identified, neurologists can bring a unique perspective to treatment. The neurologist can use his or her knowledge of the disease state to assess whether symptoms are due to poor adjustment to the neurological condition, a primary psychiatric disorder, or the biological underpinnings of the illness or prescribed medications. “I think their neurologist can sort of help tease that apart, [using] their knowledge of neurologic disorders and pathways and medications in a way that psychologists might not be able to do on their own,” said Dr. McNulty.

She also emphasized that there are effective treatments for psychiatric disorders, including cognitive behavioral therapy and various pharmacotherapy options. Other approaches for treating comorbid neurological and psychiatric disorders may include building adaptive coping skills, psychoeducation, and incorporating changes to the family or school environment.

During the Q&A period, one person commented that there should be more psychiatric training for neurology residents. “We do work with the same brain, so I completely agree with that,” said Dr. McNulty.

She was also asked how to identify psychiatric symptoms in nonverbal patients. “One thing that I pay close attention to when I ask parents about (their child) is changes in their physical (attributes). Oftentimes in anxiety in folks who are not severely impaired, if we’re feeling anxious we might be breathing a little faster, or we might get a little sweaty. So looking for physical manifestations is one thing. And then sometimes I’ll tell the parents, if we’re not quite sure, I’ll say ‘I’m not sure, but this is very common given the disorder that you have. Can we check?’ I’m always very clear that I may not be nailing it, but then when we go after it with targeted treatment and we see it getting better, we can say ‘Aha!’ ”

Dr. McNulty has no relevant financial disclosures.
 

CINCINNATI – Neurology and psychiatry have an inherent kinship, as one often deals with the brain and the other always focuses on the mind. The two fields can be intertwined, since neurological conditions are often associated with psychiatric comorbidities amid complex relationships: For example, a young patient with a neurological disorder may experience anxiety due to life changes, his or her diagnosis, or altered biological pathways from the condition or medications used to treat it.

As a result, psychiatric comorbidities are often seen among pediatric patients with neurological conditions, and pediatric neurologists can play an important role in diagnosis and management of such disorders, according to Devin McNulty, PhD, who spoke on the topic at the 2022 annual meeting of the Child Neurology Society.
 

The ‘second pandemic’

Mental health conditions represent about 16% of the global burden of disease among people aged 10-19, and the COVID-19 pandemic has drastically worsened the problem, as shutdowns, school loss, and economic struggles have added to the burden. “I think we’ve really seen mental health as sort of the second pandemic. We’ve seen this in Chicago in our emergency room, and in outpatient clinics wait-lists are really high. I think adolescents are specifically at risk,” said Dr. McNulty during her talk. She is an assistant professor of psychiatry and behavioral sciences at Northwestern University and a child psychiatrist at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Common diagnoses include major depressive order, social anxiety disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, somatic symptom disorder, and functional neurological symptom disorder. The last can appear as neurological symptoms that are not consistent with neurological medical conditions, such as attacks or seizures, abnormal movements, sensory loss or gain, weakness or paralysis, or speech and swallowing issues. It is the second most commonly diagnosed disorder in neurology clinics and accounts for 10% of neurology hospitalizations, and it leads to high rates of health care utilization and functional impairment.

Overall, children with neurological conditions are at about a 5-fold increased risk for depression and anxiety disorders, with a range of contributing risk factors. These include biological factors like medication use, neurological dysfunction, and genetic vulnerability. Psychological factors include stressors, the child’s reaction to the diagnosis and illness, and the level of his or her coping skills. Psychiatric comorbidities may also be triggered by social factors such as familial stress, peer rejection and social isolation, and barriers to treatment for the neurological condition. As just one example, overprotective parenting behavior, while adaptive in moderation, can create a sort of feedback loop that can lead to separation anxiety.
 

A unique opportunity

“There’s an overlap,” Dr. McNulty said, “because the origin is often multifactorial.” A young patient has a medical condition, which can be chronic or disabling, and the age of onset and diagnosis comes during a critical developmental period. “Then we have issues such as the impact of treatments, whether that’s medication side effects or medical visits. And then disease-related environmental changes, such as family factors, social changes, and impact on school,” said Dr. McNulty.

Child neurologists are in a unique position to identify and ensure treatment of these psychiatric comorbidities, according to Dr. McNulty. “Child neurologists will see psychiatric symptoms in their patient population, and pediatric providers have a unique capacity and ability to treat these patients, especially when you’re seeing patients on a frequent basis. You get to know these patients and their families really well,” she said.

She specifically pointed to three areas: psychosocial screening, differential diagnosis, and treatment and management.

There are broad-based screening measures that can be useful, such as the Strengths and Difficulties Questionnaire and the Pediatric Symptom Checklist. Disorder-specific screening tools include the PHQ-9 (depression), GAD7 (anxiety), Vanderbilt (ADHD), and PROMIS measures for anxiety and depression. “The idea behind the screening measure is that all patients would fill this out and then if a patient screens positive, they would benefit from a more thorough evaluation and history,” said Dr. McNulty.

However, she noted that screening shouldn’t necessarily be a one-off effort. Research has shown that sequential screening is the most powerful strategy. “Then you can get a baseline of a patient’s emotional and behavioral functioning, and it’s actually the changes in some of these screening measures that might give them most clinical information,” said Dr. McNulty.

In fact, on October 11, 2022, the U.S. Preventive Services Task Force announced a recommendation that all children starting at age 8 should be screened for anxiety disorders. It is already recommended to screen children aged 12 and over for depressive disorders, although these documents are aimed primarily at pediatricians or primary care clinics. The American Academy of Neurology has also recommended routine screening of psychiatric and behavioral disorders among children with epilepsy.
 

A unique perspective

Once a disorder is identified, neurologists can bring a unique perspective to treatment. The neurologist can use his or her knowledge of the disease state to assess whether symptoms are due to poor adjustment to the neurological condition, a primary psychiatric disorder, or the biological underpinnings of the illness or prescribed medications. “I think their neurologist can sort of help tease that apart, [using] their knowledge of neurologic disorders and pathways and medications in a way that psychologists might not be able to do on their own,” said Dr. McNulty.

She also emphasized that there are effective treatments for psychiatric disorders, including cognitive behavioral therapy and various pharmacotherapy options. Other approaches for treating comorbid neurological and psychiatric disorders may include building adaptive coping skills, psychoeducation, and incorporating changes to the family or school environment.

During the Q&A period, one person commented that there should be more psychiatric training for neurology residents. “We do work with the same brain, so I completely agree with that,” said Dr. McNulty.

She was also asked how to identify psychiatric symptoms in nonverbal patients. “One thing that I pay close attention to when I ask parents about (their child) is changes in their physical (attributes). Oftentimes in anxiety in folks who are not severely impaired, if we’re feeling anxious we might be breathing a little faster, or we might get a little sweaty. So looking for physical manifestations is one thing. And then sometimes I’ll tell the parents, if we’re not quite sure, I’ll say ‘I’m not sure, but this is very common given the disorder that you have. Can we check?’ I’m always very clear that I may not be nailing it, but then when we go after it with targeted treatment and we see it getting better, we can say ‘Aha!’ ”

Dr. McNulty has no relevant financial disclosures.
 

CINCINNATI – Neurology and psychiatry have an inherent kinship, as one often deals with the brain and the other always focuses on the mind. The two fields can be intertwined, since neurological conditions are often associated with psychiatric comorbidities amid complex relationships: For example, a young patient with a neurological disorder may experience anxiety due to life changes, his or her diagnosis, or altered biological pathways from the condition or medications used to treat it.

As a result, psychiatric comorbidities are often seen among pediatric patients with neurological conditions, and pediatric neurologists can play an important role in diagnosis and management of such disorders, according to Devin McNulty, PhD, who spoke on the topic at the 2022 annual meeting of the Child Neurology Society.
 

The ‘second pandemic’

Mental health conditions represent about 16% of the global burden of disease among people aged 10-19, and the COVID-19 pandemic has drastically worsened the problem, as shutdowns, school loss, and economic struggles have added to the burden. “I think we’ve really seen mental health as sort of the second pandemic. We’ve seen this in Chicago in our emergency room, and in outpatient clinics wait-lists are really high. I think adolescents are specifically at risk,” said Dr. McNulty during her talk. She is an assistant professor of psychiatry and behavioral sciences at Northwestern University and a child psychiatrist at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Common diagnoses include major depressive order, social anxiety disorder, generalized anxiety disorder, post-traumatic stress disorder, obsessive-compulsive disorder, somatic symptom disorder, and functional neurological symptom disorder. The last can appear as neurological symptoms that are not consistent with neurological medical conditions, such as attacks or seizures, abnormal movements, sensory loss or gain, weakness or paralysis, or speech and swallowing issues. It is the second most commonly diagnosed disorder in neurology clinics and accounts for 10% of neurology hospitalizations, and it leads to high rates of health care utilization and functional impairment.

Overall, children with neurological conditions are at about a 5-fold increased risk for depression and anxiety disorders, with a range of contributing risk factors. These include biological factors like medication use, neurological dysfunction, and genetic vulnerability. Psychological factors include stressors, the child’s reaction to the diagnosis and illness, and the level of his or her coping skills. Psychiatric comorbidities may also be triggered by social factors such as familial stress, peer rejection and social isolation, and barriers to treatment for the neurological condition. As just one example, overprotective parenting behavior, while adaptive in moderation, can create a sort of feedback loop that can lead to separation anxiety.
 

A unique opportunity

“There’s an overlap,” Dr. McNulty said, “because the origin is often multifactorial.” A young patient has a medical condition, which can be chronic or disabling, and the age of onset and diagnosis comes during a critical developmental period. “Then we have issues such as the impact of treatments, whether that’s medication side effects or medical visits. And then disease-related environmental changes, such as family factors, social changes, and impact on school,” said Dr. McNulty.

Child neurologists are in a unique position to identify and ensure treatment of these psychiatric comorbidities, according to Dr. McNulty. “Child neurologists will see psychiatric symptoms in their patient population, and pediatric providers have a unique capacity and ability to treat these patients, especially when you’re seeing patients on a frequent basis. You get to know these patients and their families really well,” she said.

She specifically pointed to three areas: psychosocial screening, differential diagnosis, and treatment and management.

There are broad-based screening measures that can be useful, such as the Strengths and Difficulties Questionnaire and the Pediatric Symptom Checklist. Disorder-specific screening tools include the PHQ-9 (depression), GAD7 (anxiety), Vanderbilt (ADHD), and PROMIS measures for anxiety and depression. “The idea behind the screening measure is that all patients would fill this out and then if a patient screens positive, they would benefit from a more thorough evaluation and history,” said Dr. McNulty.

However, she noted that screening shouldn’t necessarily be a one-off effort. Research has shown that sequential screening is the most powerful strategy. “Then you can get a baseline of a patient’s emotional and behavioral functioning, and it’s actually the changes in some of these screening measures that might give them most clinical information,” said Dr. McNulty.

In fact, on October 11, 2022, the U.S. Preventive Services Task Force announced a recommendation that all children starting at age 8 should be screened for anxiety disorders. It is already recommended to screen children aged 12 and over for depressive disorders, although these documents are aimed primarily at pediatricians or primary care clinics. The American Academy of Neurology has also recommended routine screening of psychiatric and behavioral disorders among children with epilepsy.
 

A unique perspective

Once a disorder is identified, neurologists can bring a unique perspective to treatment. The neurologist can use his or her knowledge of the disease state to assess whether symptoms are due to poor adjustment to the neurological condition, a primary psychiatric disorder, or the biological underpinnings of the illness or prescribed medications. “I think their neurologist can sort of help tease that apart, [using] their knowledge of neurologic disorders and pathways and medications in a way that psychologists might not be able to do on their own,” said Dr. McNulty.

She also emphasized that there are effective treatments for psychiatric disorders, including cognitive behavioral therapy and various pharmacotherapy options. Other approaches for treating comorbid neurological and psychiatric disorders may include building adaptive coping skills, psychoeducation, and incorporating changes to the family or school environment.

During the Q&A period, one person commented that there should be more psychiatric training for neurology residents. “We do work with the same brain, so I completely agree with that,” said Dr. McNulty.

She was also asked how to identify psychiatric symptoms in nonverbal patients. “One thing that I pay close attention to when I ask parents about (their child) is changes in their physical (attributes). Oftentimes in anxiety in folks who are not severely impaired, if we’re feeling anxious we might be breathing a little faster, or we might get a little sweaty. So looking for physical manifestations is one thing. And then sometimes I’ll tell the parents, if we’re not quite sure, I’ll say ‘I’m not sure, but this is very common given the disorder that you have. Can we check?’ I’m always very clear that I may not be nailing it, but then when we go after it with targeted treatment and we see it getting better, we can say ‘Aha!’ ”

Dr. McNulty has no relevant financial disclosures.
 

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents – one that predominantly occurs in males and typically after the second dose.

The new data also indicate a “mild and benign” clinical course of myocarditis after vaccination, with “favorable” long-term prognosis based on cardiac imaging findings.

Guy Witberg, MD, MPH, Rabin Medical Center, Petah Tikva, Israel, and colleagues report their latest observations in correspondence in The New England Journal of Medicine, online.

The group previously reported in December 2021 that the incidence of myocarditis in Israel after receipt of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine was highest among males between the ages of 16 and 29 (10.7 cases per 100,000).

The vaccine has since been approved for adolescents aged 12-15. Initial evidence for this age group, reported by Dr. Witberg and colleagues in March 2022, suggests a similar low incidence and mild course of myocarditis, although follow-up was limited to 30 days.

In their latest report, with follow-up out to 6 months, Dr. Witberg and colleagues identified nine probable or definite cases of myocarditis among 182,605 Israeli adolescents aged 12-15 who received the Pfizer/BioNTech mRNA vaccine – an incidence of 4.8 cases per 100,000.

Eight cases occurred after the second vaccine dose. All nine cases were mild.

Cardiac and inflammatory markers were elevated in all adolescent patients and electrocardiographic results were abnormal in two-thirds.

Eight patients had a normal ejection fraction, and four had a pericardial effusion. The patients spent 2-4 days hospitalized, and the in-hospital course was uneventful.

Echocardiographic findings were available a median of 10 days after discharge for eight patients. All echocardiograms showed a normal ejection fraction and resolution of pericardial effusion.

Five patients underwent cardiac MRI, including three scans performed at a median of 104 days after discharge. The scans showed “minimal evidence” of myocardial scarring or fibrosis, with evidence of late gadolinium enhancement ranging from 0% to 2%.

At a median of 206 days following discharge, all of the patients were alive, and none had been readmitted to the hospital, Dr. Witberg and colleagues report.

This research had no specific funding. Five authors have received research grants from Pfizer.

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

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents – one that predominantly occurs in males and typically after the second dose.

The new data also indicate a “mild and benign” clinical course of myocarditis after vaccination, with “favorable” long-term prognosis based on cardiac imaging findings.

Guy Witberg, MD, MPH, Rabin Medical Center, Petah Tikva, Israel, and colleagues report their latest observations in correspondence in The New England Journal of Medicine, online.

The group previously reported in December 2021 that the incidence of myocarditis in Israel after receipt of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine was highest among males between the ages of 16 and 29 (10.7 cases per 100,000).

The vaccine has since been approved for adolescents aged 12-15. Initial evidence for this age group, reported by Dr. Witberg and colleagues in March 2022, suggests a similar low incidence and mild course of myocarditis, although follow-up was limited to 30 days.

In their latest report, with follow-up out to 6 months, Dr. Witberg and colleagues identified nine probable or definite cases of myocarditis among 182,605 Israeli adolescents aged 12-15 who received the Pfizer/BioNTech mRNA vaccine – an incidence of 4.8 cases per 100,000.

Eight cases occurred after the second vaccine dose. All nine cases were mild.

Cardiac and inflammatory markers were elevated in all adolescent patients and electrocardiographic results were abnormal in two-thirds.

Eight patients had a normal ejection fraction, and four had a pericardial effusion. The patients spent 2-4 days hospitalized, and the in-hospital course was uneventful.

Echocardiographic findings were available a median of 10 days after discharge for eight patients. All echocardiograms showed a normal ejection fraction and resolution of pericardial effusion.

Five patients underwent cardiac MRI, including three scans performed at a median of 104 days after discharge. The scans showed “minimal evidence” of myocardial scarring or fibrosis, with evidence of late gadolinium enhancement ranging from 0% to 2%.

At a median of 206 days following discharge, all of the patients were alive, and none had been readmitted to the hospital, Dr. Witberg and colleagues report.

This research had no specific funding. Five authors have received research grants from Pfizer.

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

New data from Israel provide further evidence that myocarditis is a rare adverse event of vaccination with the Pfizer/BioNTech mRNA COVID-19 vaccine in adolescents – one that predominantly occurs in males and typically after the second dose.

The new data also indicate a “mild and benign” clinical course of myocarditis after vaccination, with “favorable” long-term prognosis based on cardiac imaging findings.

Guy Witberg, MD, MPH, Rabin Medical Center, Petah Tikva, Israel, and colleagues report their latest observations in correspondence in The New England Journal of Medicine, online.

The group previously reported in December 2021 that the incidence of myocarditis in Israel after receipt of the Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine was highest among males between the ages of 16 and 29 (10.7 cases per 100,000).

The vaccine has since been approved for adolescents aged 12-15. Initial evidence for this age group, reported by Dr. Witberg and colleagues in March 2022, suggests a similar low incidence and mild course of myocarditis, although follow-up was limited to 30 days.

In their latest report, with follow-up out to 6 months, Dr. Witberg and colleagues identified nine probable or definite cases of myocarditis among 182,605 Israeli adolescents aged 12-15 who received the Pfizer/BioNTech mRNA vaccine – an incidence of 4.8 cases per 100,000.

Eight cases occurred after the second vaccine dose. All nine cases were mild.

Cardiac and inflammatory markers were elevated in all adolescent patients and electrocardiographic results were abnormal in two-thirds.

Eight patients had a normal ejection fraction, and four had a pericardial effusion. The patients spent 2-4 days hospitalized, and the in-hospital course was uneventful.

Echocardiographic findings were available a median of 10 days after discharge for eight patients. All echocardiograms showed a normal ejection fraction and resolution of pericardial effusion.

Five patients underwent cardiac MRI, including three scans performed at a median of 104 days after discharge. The scans showed “minimal evidence” of myocardial scarring or fibrosis, with evidence of late gadolinium enhancement ranging from 0% to 2%.

At a median of 206 days following discharge, all of the patients were alive, and none had been readmitted to the hospital, Dr. Witberg and colleagues report.

This research had no specific funding. Five authors have received research grants from Pfizer.

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

Birth parents are typically separated from their newborns following a cesarean section. However, a recent study published in the journal Nursing Open suggests immediate skin-to-skin contact may accelerate uterine contractions, reduce maternal blood loss, reduce newborn crying, improve patient satisfaction and comfort, and increase the rate of breastfeeding.

“[O]ur study contributes to scientific knowledge with key information to reduce maternal morbidity and mortality rates in mothers who have undergone scheduled cesarean sections,” José Miguel Pérez-Jiménez, MD, of the faculty of nursing, physiotherapy, and podiatry at Hospital Universitario Virgen Macarena, University of Sevilla, Spain, and colleagues wrote in their study. It promotes greater stability in the mothers by reducing the risk of postpartum hemorrhage, making it better to not separate mother and child in the first hours after this surgery, he said.

Dr. Pérez-Jiménez and colleagues evaluated 83 women who underwent a scheduled cesarean section in an unblinded, randomized controlled trial. The women were randomized to receive skin-to-skin contact in the operating room that continued in the postpartum unit, or the normal protocol after cesarean section that consisted of having the mother transferred to the postanesthesia recovery room while the newborn was sent to a maternity room with a parent or companion. Researchers assessed variables such as plasma hemoglobin, uterine contractions, breastfeeding, and postoperative pain, as well as subjective measures such as maternal satisfaction, comfort, previous cesarean section experience, and newborn crying.

Women who received usual care following cesarean section were more likely to have uterine contractions at the umbilical level compared with the skin-to-skin contact group (70% vs. 3%; P ≤ .0001), while the skin-to-skin group was more likely to have uterine contractions at the infraumbilical level (92.5% vs. 22.5%; P ≤ .0001). There was a statistically significant decrease in predischarge hemoglobin in the control group compared with the skin-to-skin group (10.522 vs. 11.075 g/dL; P ≤ .017); the level of hemoglobin reduction favored the skin-to-skin group (1.01 vs. 2.265 g/dL; P ≤ .0001). Women in the skin-to-skin group were more likely to report mild pain on a 10-point visual analog scale (VAS) after being transferred to the recovery room (1.48 vs. 6.23 points; P ≤ .0001) and being transferred to a maternity room or room in the postpartum unit (0.60 vs. 5.23 points; P ≤ .0001). Breastfeeding at birth was significantly higher among patients with immediate skin-to-skin contact compared with the control group (92.5% vs. 32.5%; P ≤ .0001), and continued at 1 month after birth (92.5% vs. 12.5%; P ≤ .0001). Newborns of mothers in the skin-to-skin group were significantly less likely to cry compared with newborns in the control group (90% vs. 55%; P ≤ .001).

When asked to rate their satisfaction on a 10-point Likert scale, women in the skin-to-skin contact group rated their experience significantly higher than did the control group (9.98 vs. 6.5; P ≤ .0001), and all women who had previously had a cesarean section in the skin-to-skin group (30%) rated their experience at 10 points compared with their previous cesarean section without skin-to-skin contact.
 

Implementing skin-to-skin contact after cesarean section

Betsy M. Collins, MD, MPH, assistant professor of obstetrics and gynecology at Emory University, Atlanta, said in an interview that while some of the findings were largely unsurprising and “confirmed a lot of the things that we already know about skin-to-skin [contact],” one major finding was the “stark difference” in the percentage of new birth parents who started breastfeeding after skin-to-skin contact and were still breastfeeding at 1 month postpartum compared with birth parents in the control group. She was not involved with the study and noted that the results complement recommendations from the World Health Organization on starting breastfeeding within the first hour after birth and continuing breastfeeding through the first 6 months of life.

“That was likely one of the greatest take-home points from the study ... that early skin-to-skin really promoted initiation of breastfeeding,” Dr. Collins said.

Two reasons why skin-to-skin contact after cesarean section isn’t regularly provided is that it can be difficult for personnel and safety reasons to have an extra nurse to continue monitoring the health of the newborn in the operating room, and there is a lack of culture supporting of skin-to-skin contact in the OR, Dr. Collins explained.

“Just like anything else, if it’s built into your standard operating procedure, then you have everything set up in place to do that initial assessment of the infant and then get the baby skin-to-skin as quickly as possible,” she said. If it’s your standard operating procedure to not provide skin-to-skin contact, she said, then there is a little bit more inertia to overcome to start providing it as a standard procedure.

At her center, Dr. Collins said skin-to-skin contact is initiated as soon as possible after birth, even in the operating room. The steps to implementing that policy involved getting the anesthesiology department on board with supporting the policy in the OR and training the circulating nursing staff to ensure a that nurse is available to monitor the newborn.

“I think the most important thing to know is that it’s absolutely doable and that you just have to have a champion just like any other quality initiative,” she said. One of the best ways to do that is to have the patients themselves request it, she noted, compared with its being requested by a physician or nurse.

“I think some patients are disappointed when they have to undergo cesarean delivery or feel like they’re missing out if they can’t have a vaginal delivery,” Dr. Collins said. Immediate skin-to-skin contact is “very good for not only physiology, as we read about in this paper – all the things they said about the benefits of skin-to-skin [contact] are true – but it’s really good for mental health. That bonding begins right away.”

As a birth parent, being separated from your newborn for several hours after a cesarean section, on the other hand, can be “pretty devastating,” Dr. Collins said.

“I think this is something that, once it becomes a standard of care, it will be expected that most hospitals should be doing this,” she said.

The authors and Dr. Collins report no relevant conflicts of interest.

Birth parents are typically separated from their newborns following a cesarean section. However, a recent study published in the journal Nursing Open suggests immediate skin-to-skin contact may accelerate uterine contractions, reduce maternal blood loss, reduce newborn crying, improve patient satisfaction and comfort, and increase the rate of breastfeeding.

“[O]ur study contributes to scientific knowledge with key information to reduce maternal morbidity and mortality rates in mothers who have undergone scheduled cesarean sections,” José Miguel Pérez-Jiménez, MD, of the faculty of nursing, physiotherapy, and podiatry at Hospital Universitario Virgen Macarena, University of Sevilla, Spain, and colleagues wrote in their study. It promotes greater stability in the mothers by reducing the risk of postpartum hemorrhage, making it better to not separate mother and child in the first hours after this surgery, he said.

Dr. Pérez-Jiménez and colleagues evaluated 83 women who underwent a scheduled cesarean section in an unblinded, randomized controlled trial. The women were randomized to receive skin-to-skin contact in the operating room that continued in the postpartum unit, or the normal protocol after cesarean section that consisted of having the mother transferred to the postanesthesia recovery room while the newborn was sent to a maternity room with a parent or companion. Researchers assessed variables such as plasma hemoglobin, uterine contractions, breastfeeding, and postoperative pain, as well as subjective measures such as maternal satisfaction, comfort, previous cesarean section experience, and newborn crying.

Women who received usual care following cesarean section were more likely to have uterine contractions at the umbilical level compared with the skin-to-skin contact group (70% vs. 3%; P ≤ .0001), while the skin-to-skin group was more likely to have uterine contractions at the infraumbilical level (92.5% vs. 22.5%; P ≤ .0001). There was a statistically significant decrease in predischarge hemoglobin in the control group compared with the skin-to-skin group (10.522 vs. 11.075 g/dL; P ≤ .017); the level of hemoglobin reduction favored the skin-to-skin group (1.01 vs. 2.265 g/dL; P ≤ .0001). Women in the skin-to-skin group were more likely to report mild pain on a 10-point visual analog scale (VAS) after being transferred to the recovery room (1.48 vs. 6.23 points; P ≤ .0001) and being transferred to a maternity room or room in the postpartum unit (0.60 vs. 5.23 points; P ≤ .0001). Breastfeeding at birth was significantly higher among patients with immediate skin-to-skin contact compared with the control group (92.5% vs. 32.5%; P ≤ .0001), and continued at 1 month after birth (92.5% vs. 12.5%; P ≤ .0001). Newborns of mothers in the skin-to-skin group were significantly less likely to cry compared with newborns in the control group (90% vs. 55%; P ≤ .001).

When asked to rate their satisfaction on a 10-point Likert scale, women in the skin-to-skin contact group rated their experience significantly higher than did the control group (9.98 vs. 6.5; P ≤ .0001), and all women who had previously had a cesarean section in the skin-to-skin group (30%) rated their experience at 10 points compared with their previous cesarean section without skin-to-skin contact.
 

Implementing skin-to-skin contact after cesarean section

Betsy M. Collins, MD, MPH, assistant professor of obstetrics and gynecology at Emory University, Atlanta, said in an interview that while some of the findings were largely unsurprising and “confirmed a lot of the things that we already know about skin-to-skin [contact],” one major finding was the “stark difference” in the percentage of new birth parents who started breastfeeding after skin-to-skin contact and were still breastfeeding at 1 month postpartum compared with birth parents in the control group. She was not involved with the study and noted that the results complement recommendations from the World Health Organization on starting breastfeeding within the first hour after birth and continuing breastfeeding through the first 6 months of life.

“That was likely one of the greatest take-home points from the study ... that early skin-to-skin really promoted initiation of breastfeeding,” Dr. Collins said.

Two reasons why skin-to-skin contact after cesarean section isn’t regularly provided is that it can be difficult for personnel and safety reasons to have an extra nurse to continue monitoring the health of the newborn in the operating room, and there is a lack of culture supporting of skin-to-skin contact in the OR, Dr. Collins explained.

“Just like anything else, if it’s built into your standard operating procedure, then you have everything set up in place to do that initial assessment of the infant and then get the baby skin-to-skin as quickly as possible,” she said. If it’s your standard operating procedure to not provide skin-to-skin contact, she said, then there is a little bit more inertia to overcome to start providing it as a standard procedure.

At her center, Dr. Collins said skin-to-skin contact is initiated as soon as possible after birth, even in the operating room. The steps to implementing that policy involved getting the anesthesiology department on board with supporting the policy in the OR and training the circulating nursing staff to ensure a that nurse is available to monitor the newborn.

“I think the most important thing to know is that it’s absolutely doable and that you just have to have a champion just like any other quality initiative,” she said. One of the best ways to do that is to have the patients themselves request it, she noted, compared with its being requested by a physician or nurse.

“I think some patients are disappointed when they have to undergo cesarean delivery or feel like they’re missing out if they can’t have a vaginal delivery,” Dr. Collins said. Immediate skin-to-skin contact is “very good for not only physiology, as we read about in this paper – all the things they said about the benefits of skin-to-skin [contact] are true – but it’s really good for mental health. That bonding begins right away.”

As a birth parent, being separated from your newborn for several hours after a cesarean section, on the other hand, can be “pretty devastating,” Dr. Collins said.

“I think this is something that, once it becomes a standard of care, it will be expected that most hospitals should be doing this,” she said.

The authors and Dr. Collins report no relevant conflicts of interest.

Birth parents are typically separated from their newborns following a cesarean section. However, a recent study published in the journal Nursing Open suggests immediate skin-to-skin contact may accelerate uterine contractions, reduce maternal blood loss, reduce newborn crying, improve patient satisfaction and comfort, and increase the rate of breastfeeding.

“[O]ur study contributes to scientific knowledge with key information to reduce maternal morbidity and mortality rates in mothers who have undergone scheduled cesarean sections,” José Miguel Pérez-Jiménez, MD, of the faculty of nursing, physiotherapy, and podiatry at Hospital Universitario Virgen Macarena, University of Sevilla, Spain, and colleagues wrote in their study. It promotes greater stability in the mothers by reducing the risk of postpartum hemorrhage, making it better to not separate mother and child in the first hours after this surgery, he said.

Dr. Pérez-Jiménez and colleagues evaluated 83 women who underwent a scheduled cesarean section in an unblinded, randomized controlled trial. The women were randomized to receive skin-to-skin contact in the operating room that continued in the postpartum unit, or the normal protocol after cesarean section that consisted of having the mother transferred to the postanesthesia recovery room while the newborn was sent to a maternity room with a parent or companion. Researchers assessed variables such as plasma hemoglobin, uterine contractions, breastfeeding, and postoperative pain, as well as subjective measures such as maternal satisfaction, comfort, previous cesarean section experience, and newborn crying.

Women who received usual care following cesarean section were more likely to have uterine contractions at the umbilical level compared with the skin-to-skin contact group (70% vs. 3%; P ≤ .0001), while the skin-to-skin group was more likely to have uterine contractions at the infraumbilical level (92.5% vs. 22.5%; P ≤ .0001). There was a statistically significant decrease in predischarge hemoglobin in the control group compared with the skin-to-skin group (10.522 vs. 11.075 g/dL; P ≤ .017); the level of hemoglobin reduction favored the skin-to-skin group (1.01 vs. 2.265 g/dL; P ≤ .0001). Women in the skin-to-skin group were more likely to report mild pain on a 10-point visual analog scale (VAS) after being transferred to the recovery room (1.48 vs. 6.23 points; P ≤ .0001) and being transferred to a maternity room or room in the postpartum unit (0.60 vs. 5.23 points; P ≤ .0001). Breastfeeding at birth was significantly higher among patients with immediate skin-to-skin contact compared with the control group (92.5% vs. 32.5%; P ≤ .0001), and continued at 1 month after birth (92.5% vs. 12.5%; P ≤ .0001). Newborns of mothers in the skin-to-skin group were significantly less likely to cry compared with newborns in the control group (90% vs. 55%; P ≤ .001).

When asked to rate their satisfaction on a 10-point Likert scale, women in the skin-to-skin contact group rated their experience significantly higher than did the control group (9.98 vs. 6.5; P ≤ .0001), and all women who had previously had a cesarean section in the skin-to-skin group (30%) rated their experience at 10 points compared with their previous cesarean section without skin-to-skin contact.
 

Implementing skin-to-skin contact after cesarean section

Betsy M. Collins, MD, MPH, assistant professor of obstetrics and gynecology at Emory University, Atlanta, said in an interview that while some of the findings were largely unsurprising and “confirmed a lot of the things that we already know about skin-to-skin [contact],” one major finding was the “stark difference” in the percentage of new birth parents who started breastfeeding after skin-to-skin contact and were still breastfeeding at 1 month postpartum compared with birth parents in the control group. She was not involved with the study and noted that the results complement recommendations from the World Health Organization on starting breastfeeding within the first hour after birth and continuing breastfeeding through the first 6 months of life.

“That was likely one of the greatest take-home points from the study ... that early skin-to-skin really promoted initiation of breastfeeding,” Dr. Collins said.

Two reasons why skin-to-skin contact after cesarean section isn’t regularly provided is that it can be difficult for personnel and safety reasons to have an extra nurse to continue monitoring the health of the newborn in the operating room, and there is a lack of culture supporting of skin-to-skin contact in the OR, Dr. Collins explained.

“Just like anything else, if it’s built into your standard operating procedure, then you have everything set up in place to do that initial assessment of the infant and then get the baby skin-to-skin as quickly as possible,” she said. If it’s your standard operating procedure to not provide skin-to-skin contact, she said, then there is a little bit more inertia to overcome to start providing it as a standard procedure.

At her center, Dr. Collins said skin-to-skin contact is initiated as soon as possible after birth, even in the operating room. The steps to implementing that policy involved getting the anesthesiology department on board with supporting the policy in the OR and training the circulating nursing staff to ensure a that nurse is available to monitor the newborn.

“I think the most important thing to know is that it’s absolutely doable and that you just have to have a champion just like any other quality initiative,” she said. One of the best ways to do that is to have the patients themselves request it, she noted, compared with its being requested by a physician or nurse.

“I think some patients are disappointed when they have to undergo cesarean delivery or feel like they’re missing out if they can’t have a vaginal delivery,” Dr. Collins said. Immediate skin-to-skin contact is “very good for not only physiology, as we read about in this paper – all the things they said about the benefits of skin-to-skin [contact] are true – but it’s really good for mental health. That bonding begins right away.”

As a birth parent, being separated from your newborn for several hours after a cesarean section, on the other hand, can be “pretty devastating,” Dr. Collins said.

“I think this is something that, once it becomes a standard of care, it will be expected that most hospitals should be doing this,” she said.

The authors and Dr. Collins report no relevant conflicts of interest.

CINCINNATI – A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

CINCINNATI – A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

CINCINNATI – A new analysis of data from a phase 3 clinical trial suggests that an inhaled diazepam nasal spray (Valtoco, Neurelis Inc.) works about as well among patients with Lennox-Gastaut Syndrome (LGS) as it does with other patients with pediatric encephalopathies.

LGS is a severe form of epilepsy that generally begins in early childhood and has a poor prognosis and seizures that are often treatment refractory. The findings of the analysis should be encouraging to physicians who may view patients with LGS as not benefiting from treatment, said Daniel C. Tarquinio, DO, who presented the results at the 2022 annual meeting of the Child Neurology Society.

“Their response to their first appropriate weight-based rescue dose of Valtoco was essentially no different. They were subtly different, but they’re not really meaningful differences. Very few needed a second dose. In practice this is helpful because we know that kids with LGS, we think of them as having worse epilepsy, if you will. But if they need rescue, if we prescribe an appropriate rescue dose based on their weight, that the same rescue will work for them as it will for a kid that doesn’t have – quote unquote – as bad epilepsy that needs rescue,” said Dr. Tarquinio, a child neurologist and epileptologist and founder of the Center for Rare Neurological Diseases.

During the Q&A, Dr. Tarquinio was asked if there is something about the biology of LGS that would suggest it might respond differently to the drug. Dr. Tarquinio said no. “The reason we even looked at this is because many clinicians told us that their sense was [that patients with LGS] did not respond as well to rescue in general no matter what they use. This allowed us to go back and look at a controlled data set and say, at least in our controlled dataset, they respond the same,” he said.

Grace Gombolay, MD, who moderated the session, agreed that the results should be encouraging. “It seems like a lot of clinicians have the sense that Lennox-Gastaut Syndrome is a very terrible refractory epilepsy syndrome, and so doing rescue doesn’t seem to make sense if they don’t really respond. I think it’s helpful to know because there are actually studies showing that Valtoco seems to actually work in those patients, so it’s actually useful clinically to prescribe those patients and give it a shot,” said Dr. Gombolay, director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Emory University, Atlanta.

LGS patients may experience hundreds of seizures per day. “It’s really hard for parents to quantify, did they get better? Did the rescue help or not, because they’re still having some seizures. I think the sense is, ‘oh, this isn’t working.’ That’s probably the bias. I think this is good data that if you are able to get Valtoco for your patients, I think it’s worth a shot even in Lennox-Gastaut,” said Dr. Gombolay.

The researchers conducted a post hoc analysis of the phase 3, open-label, repeat-dose safety study of Valtoco. The study included a 12-month treatment period with visits at day 30 and every 60 days following. Patients had the option of staying on the drug following the end of the treatment period. Seizure and dosing information were obtained from a diary. The study enrolled 163 patients whose physicians believed they would need to be treated with a benzodiazepine at least once every other month to achieve seizure control. Dosing was determined by a combination of age and weight. If a second dose was required, caregivers were instructed to provide it 4-12 hours after the first dose.

In the study cohort, 47.9% of patients were aged 6-17 years. The researchers looked specifically at 73 cases of seizure clusters. In nine cases, the patient had LGS (five male, four female). Nearly all (95.9%) of LGS cluster cases were treated with a single dose and 4.1% were exposed to a second dose. Among 64 cases involving a patient with pediatric epileptic encephalopathies, 89.4% were treated with a single dose and 10.6% received a second. The safety profile was similar between patients with LGS and those with pediatric encephalopathies.

Dr. Gombolay has no relevant financial disclosures.

Most adolescents with gender dysphoria who took puberty-blocking drugs for at least 3 months and then progressed to cross-sex hormone treatment were still taking hormones as they entered adulthood, new research of patients at a pioneering Dutch clinic shows.

The study negates past findings that large numbers of youth regret transitioning, say Maria Anna Theodora Catharina van der Loos, MD, and colleagues from the Centre of Expertise on Gender Dysphoria, Amsterdam, in their article published online in The Lancet Child & Adolescent Health. They believe the difference between their findings and those of other studies lies in proper diagnostic evaluation.

“The study aims to demonstrate, with a methodology that is more than adequate, that transgender people who begin their transition in childhood-adolescence do not give up,” Adrián Carrasco Munera, MD, a specialist in family and community medicine and member of the LGTBIQ+ Health Group of the Madrid Society of Family and Community Medicine told the UK Science Media Centre.

The cohort included 720 youth: 220 (31%) were assigned male at birth (AMAB) and 500 (69%) were assigned female at birth (AFAB). At the start of puberty-blocking treatment with a gonadotrophin-releasing hormone agonist, the median age of patients was 14.1 years for AMAB and 16.0 years for AFAB.

Of that cohort, 704 (98%) continued hormone therapy to the end of data collection (Dec. 31, 2018), at which point the median age of patients was 20 years for AMAB and 19 years for AFAB.

Careful consideration of patient needs

All the patients received care at the “Dutch Clinic,” which more than 20 years ago pioneered the approach of giving puberty-blocking drugs to children looking to transition, followed by cross-sex hormones. The study includes the “complete adolescent population” at the facility who met the inclusion criteria.

A similar U.S. study published earlier this year found that 74.4% of individuals who had started gender-affirming hormones before age 18 were still on them 4 years after starting medical treatment.

“However, it is unclear how many of these adolescents [in the U.S. study] used puberty-suppressing treatment before gender-affirming hormone treatment and to what extent they underwent diagnostic evaluation before initiation of medical treatment,” say Dr. van der Loos and colleagues.

She told this news organization that her clinic provides “a thorough diagnostic and mental health assessment” and discussion of fertility preservation prior to any youth being prescribed puberty blockers or cross-sex hormones.

About 40% of adolescents assessed by the gender clinic in Amsterdam go on to receive hormonal treatment.

“The gender identity unit of the Amsterdam UMC is a world leader in all aspects of transgender medicine and is governed by protocolized actions. This is reflected in the quality of the data and methodology of the study, and therefore of its conclusions,” endocrinologist Gilberto Pérez López, MD, Gregorio Marañón General University Hospital, Madrid, told the UK Science Media Centre.

“These findings can and should help and guide the current public and legal debate on the initiation of medical treatment in transgender minors.”

However, he cautioned the study is limited by the fact that the data come from a registry and they looked at only prescriptions issued and not compliance.

Another interesting thing to note in the research is that almost 70% of patients were born girls and they presented at the gender clinics later in adolescence than the natal boys.

“We don’t have a sound reason for this,” Dr. van der Loos noted.

Study limitations

She also acknowledges that the short follow-up data in some individuals make it difficult to draw conclusions about regret, to some extent.

The average use of cross-sex hormones in their study was 3.5 years for males transitioning to females and 2.3 years for females transitioning to males, so on average, this wouldn’t be long enough to see regret, she acknowledged.

Prior research shows that if youth decide to detransition to their natal sex, this can take, on average, 5 years from the start of medical therapy among born females and 7 years among born males.

However, some born males in the study had been taking hormones for 20 years and some natal females for 15 years, said Dr. van der Loos.

Another limitation is that the research only followed individuals until the end of 2018 while some government data estimate that the number of teens identifying as transgender has nearly doubled over the past 5 years.

The authors, Dr. Munera, and Dr. Lopez have reported no relevant financial relationships.

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

Most adolescents with gender dysphoria who took puberty-blocking drugs for at least 3 months and then progressed to cross-sex hormone treatment were still taking hormones as they entered adulthood, new research of patients at a pioneering Dutch clinic shows.

The study negates past findings that large numbers of youth regret transitioning, say Maria Anna Theodora Catharina van der Loos, MD, and colleagues from the Centre of Expertise on Gender Dysphoria, Amsterdam, in their article published online in The Lancet Child & Adolescent Health. They believe the difference between their findings and those of other studies lies in proper diagnostic evaluation.

“The study aims to demonstrate, with a methodology that is more than adequate, that transgender people who begin their transition in childhood-adolescence do not give up,” Adrián Carrasco Munera, MD, a specialist in family and community medicine and member of the LGTBIQ+ Health Group of the Madrid Society of Family and Community Medicine told the UK Science Media Centre.

The cohort included 720 youth: 220 (31%) were assigned male at birth (AMAB) and 500 (69%) were assigned female at birth (AFAB). At the start of puberty-blocking treatment with a gonadotrophin-releasing hormone agonist, the median age of patients was 14.1 years for AMAB and 16.0 years for AFAB.

Of that cohort, 704 (98%) continued hormone therapy to the end of data collection (Dec. 31, 2018), at which point the median age of patients was 20 years for AMAB and 19 years for AFAB.

Careful consideration of patient needs

All the patients received care at the “Dutch Clinic,” which more than 20 years ago pioneered the approach of giving puberty-blocking drugs to children looking to transition, followed by cross-sex hormones. The study includes the “complete adolescent population” at the facility who met the inclusion criteria.

A similar U.S. study published earlier this year found that 74.4% of individuals who had started gender-affirming hormones before age 18 were still on them 4 years after starting medical treatment.

“However, it is unclear how many of these adolescents [in the U.S. study] used puberty-suppressing treatment before gender-affirming hormone treatment and to what extent they underwent diagnostic evaluation before initiation of medical treatment,” say Dr. van der Loos and colleagues.

She told this news organization that her clinic provides “a thorough diagnostic and mental health assessment” and discussion of fertility preservation prior to any youth being prescribed puberty blockers or cross-sex hormones.

About 40% of adolescents assessed by the gender clinic in Amsterdam go on to receive hormonal treatment.

“The gender identity unit of the Amsterdam UMC is a world leader in all aspects of transgender medicine and is governed by protocolized actions. This is reflected in the quality of the data and methodology of the study, and therefore of its conclusions,” endocrinologist Gilberto Pérez López, MD, Gregorio Marañón General University Hospital, Madrid, told the UK Science Media Centre.

“These findings can and should help and guide the current public and legal debate on the initiation of medical treatment in transgender minors.”

However, he cautioned the study is limited by the fact that the data come from a registry and they looked at only prescriptions issued and not compliance.

Another interesting thing to note in the research is that almost 70% of patients were born girls and they presented at the gender clinics later in adolescence than the natal boys.

“We don’t have a sound reason for this,” Dr. van der Loos noted.

Study limitations

She also acknowledges that the short follow-up data in some individuals make it difficult to draw conclusions about regret, to some extent.

The average use of cross-sex hormones in their study was 3.5 years for males transitioning to females and 2.3 years for females transitioning to males, so on average, this wouldn’t be long enough to see regret, she acknowledged.

Prior research shows that if youth decide to detransition to their natal sex, this can take, on average, 5 years from the start of medical therapy among born females and 7 years among born males.

However, some born males in the study had been taking hormones for 20 years and some natal females for 15 years, said Dr. van der Loos.

Another limitation is that the research only followed individuals until the end of 2018 while some government data estimate that the number of teens identifying as transgender has nearly doubled over the past 5 years.

The authors, Dr. Munera, and Dr. Lopez have reported no relevant financial relationships.

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

Most adolescents with gender dysphoria who took puberty-blocking drugs for at least 3 months and then progressed to cross-sex hormone treatment were still taking hormones as they entered adulthood, new research of patients at a pioneering Dutch clinic shows.

The study negates past findings that large numbers of youth regret transitioning, say Maria Anna Theodora Catharina van der Loos, MD, and colleagues from the Centre of Expertise on Gender Dysphoria, Amsterdam, in their article published online in The Lancet Child & Adolescent Health. They believe the difference between their findings and those of other studies lies in proper diagnostic evaluation.

“The study aims to demonstrate, with a methodology that is more than adequate, that transgender people who begin their transition in childhood-adolescence do not give up,” Adrián Carrasco Munera, MD, a specialist in family and community medicine and member of the LGTBIQ+ Health Group of the Madrid Society of Family and Community Medicine told the UK Science Media Centre.

The cohort included 720 youth: 220 (31%) were assigned male at birth (AMAB) and 500 (69%) were assigned female at birth (AFAB). At the start of puberty-blocking treatment with a gonadotrophin-releasing hormone agonist, the median age of patients was 14.1 years for AMAB and 16.0 years for AFAB.

Of that cohort, 704 (98%) continued hormone therapy to the end of data collection (Dec. 31, 2018), at which point the median age of patients was 20 years for AMAB and 19 years for AFAB.

Careful consideration of patient needs

All the patients received care at the “Dutch Clinic,” which more than 20 years ago pioneered the approach of giving puberty-blocking drugs to children looking to transition, followed by cross-sex hormones. The study includes the “complete adolescent population” at the facility who met the inclusion criteria.

A similar U.S. study published earlier this year found that 74.4% of individuals who had started gender-affirming hormones before age 18 were still on them 4 years after starting medical treatment.

“However, it is unclear how many of these adolescents [in the U.S. study] used puberty-suppressing treatment before gender-affirming hormone treatment and to what extent they underwent diagnostic evaluation before initiation of medical treatment,” say Dr. van der Loos and colleagues.

She told this news organization that her clinic provides “a thorough diagnostic and mental health assessment” and discussion of fertility preservation prior to any youth being prescribed puberty blockers or cross-sex hormones.

About 40% of adolescents assessed by the gender clinic in Amsterdam go on to receive hormonal treatment.

“The gender identity unit of the Amsterdam UMC is a world leader in all aspects of transgender medicine and is governed by protocolized actions. This is reflected in the quality of the data and methodology of the study, and therefore of its conclusions,” endocrinologist Gilberto Pérez López, MD, Gregorio Marañón General University Hospital, Madrid, told the UK Science Media Centre.

“These findings can and should help and guide the current public and legal debate on the initiation of medical treatment in transgender minors.”

However, he cautioned the study is limited by the fact that the data come from a registry and they looked at only prescriptions issued and not compliance.

Another interesting thing to note in the research is that almost 70% of patients were born girls and they presented at the gender clinics later in adolescence than the natal boys.

“We don’t have a sound reason for this,” Dr. van der Loos noted.

Study limitations

She also acknowledges that the short follow-up data in some individuals make it difficult to draw conclusions about regret, to some extent.

The average use of cross-sex hormones in their study was 3.5 years for males transitioning to females and 2.3 years for females transitioning to males, so on average, this wouldn’t be long enough to see regret, she acknowledged.

Prior research shows that if youth decide to detransition to their natal sex, this can take, on average, 5 years from the start of medical therapy among born females and 7 years among born males.

However, some born males in the study had been taking hormones for 20 years and some natal females for 15 years, said Dr. van der Loos.

Another limitation is that the research only followed individuals until the end of 2018 while some government data estimate that the number of teens identifying as transgender has nearly doubled over the past 5 years.

The authors, Dr. Munera, and Dr. Lopez have reported no relevant financial relationships.

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

MONTREAL – Daily use of full-body emollients from birth to age 1 year in infants at high risk for developing atopic dermatitis (AD) was not more effective at preventing the condition than standard skin-care advice alone, according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis.

“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham (England).

The rate of AD at 2 years – the primary outcome of the BEEP trial – have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice versus standard skin-care advice alone among 1,394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Dr. Williams explained.

At 2 years, 23% of the emollient group versus 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention but also with other related disorders, he explained.

“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Dr. Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”

The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms, and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs. 28% in controls), clinical diagnosis of food allergy (15% vs. 14%, respectively), or other outcomes.

“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Dr. Williams commented, adding that he does not recommend use of emollients for AD prevention.

“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well ... showing a positive effect,” he added, referring to the small, single-center STOP-AD trial.

“We’re always hoping, and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, told this news organization. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr. Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”

Dr. Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”

He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Dr. Drucker advised.

Dr. Williams and Dr. Drucker report no relevant financial relationships.

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

MONTREAL – Daily use of full-body emollients from birth to age 1 year in infants at high risk for developing atopic dermatitis (AD) was not more effective at preventing the condition than standard skin-care advice alone, according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis.

“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham (England).

The rate of AD at 2 years – the primary outcome of the BEEP trial – have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice versus standard skin-care advice alone among 1,394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Dr. Williams explained.

At 2 years, 23% of the emollient group versus 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention but also with other related disorders, he explained.

“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Dr. Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”

The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms, and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs. 28% in controls), clinical diagnosis of food allergy (15% vs. 14%, respectively), or other outcomes.

“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Dr. Williams commented, adding that he does not recommend use of emollients for AD prevention.

“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well ... showing a positive effect,” he added, referring to the small, single-center STOP-AD trial.

“We’re always hoping, and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, told this news organization. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr. Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”

Dr. Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”

He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Dr. Drucker advised.

Dr. Williams and Dr. Drucker report no relevant financial relationships.

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

MONTREAL – Daily use of full-body emollients from birth to age 1 year in infants at high risk for developing atopic dermatitis (AD) was not more effective at preventing the condition than standard skin-care advice alone, according to 5-year results of the BEEP randomized trial, reported at the annual meeting of the International Society of Atopic Dermatitis.

“So far, the science does not look convincing, and I am concerned about the possible harms,” commented senior investigator Hywel C. Williams, DSc, from the Centre of Evidence Based Dermatology, University of Nottingham (England).

The rate of AD at 2 years – the primary outcome of the BEEP trial – have already shown no benefit of either Diprobase cream or DoubleBase gel plus standard skin-care advice versus standard skin-care advice alone among 1,394 infants at high risk for developing AD. “These are children born to parents with a first-degree relative with eczema,” Dr. Williams explained.

At 2 years, 23% of the emollient group versus 25% of the control group developed eczema (adjusted relative risk, 0.95), and the parent-reported clinical skin infection rate was statistically increased (incidence rate ratio, 1.55). Despite these results, follow-up of BEEP was extended to 5 years to determine if there was a delayed benefit of emollients, both in AD prevention but also with other related disorders, he explained.

“Prevention is so much more logical than treating sick individuals with severe disease who present after a long chain of pathological events with expensive drugs. And even if you can’t primarily prevent eczema, even a small shift in the severity of distribution to the left has major public health implications,” Dr. Williams added. “And if you believe in the atopic march, then if you could prevent eczema, you might be able to prevent subsequent food allergy, asthma, and allergic rhinitis.”

The extension data was based on questionnaires at 3, 4, and 5 years documenting parental reports of doctor-diagnosed eczema and eczema severity, wheezing, allergic rhinitis, food allergy symptoms, and clinical diagnosis, as well as 5-year clinical diagnoses of asthma or allergic rhinitis. About 70% of parents returned their questionnaires at each point, showing no significant difference at 5 years for a clinical diagnosis of eczema (31% in the emollient group vs. 28% in controls), clinical diagnosis of food allergy (15% vs. 14%, respectively), or other outcomes.

“It’s a lovely hypothesis, but did we use the wrong emollients, or did we start it too late? Or should we start facing the possibility that maybe emollients really do not prevent eczema?” Dr. Williams commented, adding that he does not recommend use of emollients for AD prevention.

“There’s more research needed,” agreed panelist Eric Simpson, MD, professor of dermatology at Oregon Health & Science University, Portland, whose AD primary prevention CASCADE trial is expected to shed more light on the role of emollients in the near future. “And we can’t just ignore [another] randomized controlled trial that was done really well ... showing a positive effect,” he added, referring to the small, single-center STOP-AD trial.

“We’re always hoping, and it’s scientifically incredibly frustrating that none of this has borne out,” Aaron Drucker, MD, a dermatologist at Women’s College Hospital and associate professor at the University of Toronto, told this news organization. “It’s so appealing that emollients early in life would improve the skin barrier and then decrease likelihood of getting eczema. It’s great that there’s a new, large study from Dr. Simpson that is going to be coming out soon, so we’ll have another piece of this puzzle.”

Dr. Drucker said that although it sounds simple, there is much nuance in the question of emollients and skin barrier protection: “Who is the population that you ought to use the emollients in? What kind of emollient? How often and where? All of these things can influence potentially what the results of a trial might be. That’s where there’s still hope. I think the hope fades more and more as more evidence piles up.”

He added that although there currently is not enough evidence to recommend emollients for AD prevention, there is also not enough evidence of harm. “It’s nothing we should be afraid of,” Dr. Drucker advised.

Dr. Williams and Dr. Drucker report no relevant financial relationships.

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

WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.

Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
 

Deaths in under-20 group all but eliminated

It’s now rare for children to be hospitalized with chickenpox, and deaths from the infection in people younger than 20 have largely been eliminated. But benefits extend even further.

Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.

Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.

Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.

However, chickenpox is still widespread in most of the world.
 

U.S. first with universal program

The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.

The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.

“It was a burden the United States considered unacceptable,” Dr. Marin said.

The leaders had seen the control of measles and polio and wanted the same for chickenpox.
 

Two-dose vaccines started in 2007

In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.

Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.

By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.

The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.

Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).

“The second dose adds 10% or more improved protection against all varicella,” she said.

But there have been gains beyond medical advances.

Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
 

Jaw-dropping results

Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”

She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.

Dr. Marrazzo also noted the economic savings calculations.

“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.

There are also messages for the current debates over COVID-19 vaccinations.

“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.

The authors and Dr. Marrazzo report no relevant financial relationships.

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

WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.

Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
 

Deaths in under-20 group all but eliminated

It’s now rare for children to be hospitalized with chickenpox, and deaths from the infection in people younger than 20 have largely been eliminated. But benefits extend even further.

Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.

Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.

Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.

However, chickenpox is still widespread in most of the world.
 

U.S. first with universal program

The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.

The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.

“It was a burden the United States considered unacceptable,” Dr. Marin said.

The leaders had seen the control of measles and polio and wanted the same for chickenpox.
 

Two-dose vaccines started in 2007

In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.

Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.

By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.

The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.

Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).

“The second dose adds 10% or more improved protection against all varicella,” she said.

But there have been gains beyond medical advances.

Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
 

Jaw-dropping results

Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”

She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.

Dr. Marrazzo also noted the economic savings calculations.

“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.

There are also messages for the current debates over COVID-19 vaccinations.

“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.

The authors and Dr. Marrazzo report no relevant financial relationships.

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

WASHINGTON – In the 25 years since the United States first launched its universal vaccinations program to protect children against chickenpox (varicella), the program has seen dramatic results, a data analysis indicates.

Results from 1995 – when universal vaccinations began – through 2019 were presented an annual scientific meeting on infectious diseases by Mona Marin, MD, a medical epidemiologist at the Centers for Disease Control and Prevention. Researchers analyzed published data and surveillance data reported to the CDC.
 

Deaths in under-20 group all but eliminated

It’s now rare for children to be hospitalized with chickenpox, and deaths from the infection in people younger than 20 have largely been eliminated. But benefits extend even further.

Immunocompromised people or pregnant women and infants too young to be vaccinated also benefited from the children’s immunizations.

Each year, about 3.8 million cases, 10,500 hospitalizations, and 100 deaths from chickenpox are prevented in the United States thanks to the vaccination program, Dr. Marin said.

Over 25 years, 91 million cases, 238,000 hospitalizations, and 1,933 – 2,446 deaths have been prevented.

However, chickenpox is still widespread in most of the world.
 

U.S. first with universal program

The disease was thought to be of little consequence, Dr. Marin said, until the mid-1950s after the first cases of fatal varicella in immunocompromised children revealed the virus’ lethal potential.

The United States was the first country to introduce a universal vaccination program, Dr. Marin said. At the time, it was a one-dose vaccine. Within the first 10 years of the one-dose program, declines in chickenpox cases, hospitalization, and death rates went from 71% to 90% in comparison with previous years. But health care leaders wanted to close the remaining gap and target transmission in schools.

“It was a burden the United States considered unacceptable,” Dr. Marin said.

The leaders had seen the control of measles and polio and wanted the same for chickenpox.
 

Two-dose vaccines started in 2007

In 2007, the current two-dose policy was introduced. Administration of the first dose is recommended at age 12–15 months, and the second at age 4–6 years. Vaccination is required before the children enter kindergarten.

Coverage was high – at least 90% – the study authors reported; the two-dose program further reduced the number, size, and duration of outbreaks. Over the 25 years, the proportion of outbreaks with fewer than 10 cases increased from 28% to 73%.

By 2019, incidence had dropped by 97%, hospitalizations were down by 94%, and deaths had dropped by 97%.

The biggest decline was seen in those younger than 20, who were born during the vaccination program. That group saw declines of 97% to 99% in cases, hospitalizations, and incidence compared with rates before vaccinations.

Dr. Marin says one dose of the vaccine is moderately effective in preventing all varicella (82%) and is highly effective in preventing severe varicella (more than 97%).

“The second dose adds 10% or more improved protection against all varicella,” she said.

But there have been gains beyond medical advances.

Researchers calculated the economic benefit and found a net savings of $23 billion in medical costs (which also factored in lost wages from parents staying home to care for sick children).
 

Jaw-dropping results

Jeanne Marrazzo, MD, director of the division of infectious diseases at the University of Alabama at Birmingham, said in an interview that “as someone who is not a vaccinologist, the declines in deaths, let alone hospitalizations, were jaw-dropping. I hadn’t really seen a synthesis of the impact of one and two doses.”

She said the declines in zoster among young people were interesting. The big question, she said, is what impact this may have for shingles infections in middle-aged adults over time, since chickenpox and shingles are caused by the same virus.

Dr. Marrazzo also noted the economic savings calculations.

“It’s such a cheap intervention. It’s one of the best examples of how a simple vaccine can affect a cascade of events that are a result of chronic viral infection,” she said.

There are also messages for the current debates over COVID-19 vaccinations.

“For me, it is further evidence of the profound population-level effect safe vaccines can have,” Dr. Marrazzo said.

The authors and Dr. Marrazzo report no relevant financial relationships.

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

Pediatric patients with epilepsy have an increased risk of cardiovascular complications later in life, but little is known about how they progress. A new study finds that abnormalities in electrocardiograms are linked to an earlier age of diagnosis and longer epilepsy duration.

The findings could help researchers in the search for biomarkers that could predict later problems in children with epilepsy. “In pediatric neurology I think we’re a little bit removed from some of the cardiovascular complications that can happen within epilepsy, but cardiovascular complications are well established, especially in adults that have epilepsy. Adults with epilepsy are more likely to have coronary artery disease, atherosclerosis, arrhythmias, heart attacks, and sudden cardiac death. It’s a pretty substantial difference compared with their nonepileptic peers. So knowing that, the big question is, how do these changes develop, and how do we really counsel our patients in regards to these complications?” said Brittnie Bartlett, MD, during her presentation of the research at the 2022 annual meeting of the Child Neurology Society.

Identifying factors that increase cardiac complications

Previous studies suggested that epilepsy duration might be linked to cardiovascular complications. In children with Dravet syndrome, epilepsy duration has been shown to be associated with cardiac complications. Pathological T wave alternans, which indicates ventricular instability, has been observed in adults with longstanding epilepsy but not adults with newly diagnosed epilepsy.

“So our question in this preliminary report of our data is: What factors in our general pediatric epilepsy cohort can we identify that put them at a greater risk for having EKG changes, and specifically, we wanted to verify these findings from the other studies that epilepsy duration is, in fact, a risk factor for these EKG changes in general [among children] with epilepsy aside from channelopathies,” said Dr. Bartlett, who is an assistant professor at Baylor College of Medicine and a child neurologist at Texas Children’s Hospital, both in Houston.

She presented a striking finding that cardiovascular changes appear early. “The most important thing I want you all to make note of is the fact that, in this baseline study that we got on these kids, 47% already had changes that we were seeing on their EKGs,” said Dr. Bartlett.

The researchers also looked for factors associated with EKG changes, and found that duration of epilepsy and age at diagnosis were the two salient factors. “Our kids that did have EKG changes present had an average epilepsy duration of 73 months, as opposed to [the children] that did not have EKG changes and had an average epilepsy duration of 46 months,” said Dr. Bartlett.

Other factors, such epilepsy type, etiology, refractory epilepsy, and seizure frequency had no statistically significant association with EKG changes. They also saw no associations with high-risk seizure medications, even though some antiseizure drugs have been shown to be linked to EKG changes.

“We were able to confirm our hypothesis that EKG changes were more prevalent with longer duration of epilepsy. Unfortunately, we weren’t able to find any other clues that would help us counsel our patients, but this is part of a longitudinal prospective study that we’ll be following these kids over a couple of years’ time, so maybe we’ll be able to tease out some of these differences. Ideally, we’d be able to find some kind of a biomarker for future cardiovascular complications, and right now we’re working with some multivariable models to verify some of these findings,” said Dr. Bartlett.

Implications for clinical practice

During the Q&A, Dr. Bartlett was asked if all kids with epilepsy should undergo an EKG. She recommended against it for now. “At this point, I don’t think we have enough clear data to support getting an EKG on every kid with epilepsy. I do think it’s good practice to do them on all kids with channelopathies. As a general practice, I tend to have a low threshold towards many kids with epilepsy, but a lot of these cardiovascular risk factors tend to pop up more in adulthood, so it’s more preventative,” she said.

Grace Gombolay, MD, who moderated the session where the poster was presented, was asked for comment on the study. “What’s surprising about it is that up to half of patients actually had EKG changes, different what from what we see in normal population, and it’s interesting to think about the implications. One of the things that our epilepsy patients are at risk for is SUDEP – sudden, unexplained death in epilepsy. It’s interesting to think about what these EKG changes mean for clinical care. I think it’s too early to say at this time, but this might be one of those markers for SUDEP,” said Dr. Gombolay, who is an assistant professor at Emory University, Atlanta, and director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Children’s Healthcare of Atlanta.

The researchers prospectively studied 213 patients who were recruited. 46% were female, 42% were white, 41% were Hispanic, and 13% were African American. The mean age at enrollment was 116 months, and mean age of seizure onset was 45 months.

The researchers found that 47% had abnormal EKG readings. None of the changes were pathologic, but they may reflect changes to cardiac electrophysiology, according to Dr. Bartlett. Those with abnormal readings were older on average (11.6 vs. 8.3 years; P < .005) and had a longer epilepsy duration (73 vs. 46 months; P = .004).

Dr. Gombolay has no relevant financial disclosures.

Pediatric patients with epilepsy have an increased risk of cardiovascular complications later in life, but little is known about how they progress. A new study finds that abnormalities in electrocardiograms are linked to an earlier age of diagnosis and longer epilepsy duration.

The findings could help researchers in the search for biomarkers that could predict later problems in children with epilepsy. “In pediatric neurology I think we’re a little bit removed from some of the cardiovascular complications that can happen within epilepsy, but cardiovascular complications are well established, especially in adults that have epilepsy. Adults with epilepsy are more likely to have coronary artery disease, atherosclerosis, arrhythmias, heart attacks, and sudden cardiac death. It’s a pretty substantial difference compared with their nonepileptic peers. So knowing that, the big question is, how do these changes develop, and how do we really counsel our patients in regards to these complications?” said Brittnie Bartlett, MD, during her presentation of the research at the 2022 annual meeting of the Child Neurology Society.

Identifying factors that increase cardiac complications

Previous studies suggested that epilepsy duration might be linked to cardiovascular complications. In children with Dravet syndrome, epilepsy duration has been shown to be associated with cardiac complications. Pathological T wave alternans, which indicates ventricular instability, has been observed in adults with longstanding epilepsy but not adults with newly diagnosed epilepsy.

“So our question in this preliminary report of our data is: What factors in our general pediatric epilepsy cohort can we identify that put them at a greater risk for having EKG changes, and specifically, we wanted to verify these findings from the other studies that epilepsy duration is, in fact, a risk factor for these EKG changes in general [among children] with epilepsy aside from channelopathies,” said Dr. Bartlett, who is an assistant professor at Baylor College of Medicine and a child neurologist at Texas Children’s Hospital, both in Houston.

She presented a striking finding that cardiovascular changes appear early. “The most important thing I want you all to make note of is the fact that, in this baseline study that we got on these kids, 47% already had changes that we were seeing on their EKGs,” said Dr. Bartlett.

The researchers also looked for factors associated with EKG changes, and found that duration of epilepsy and age at diagnosis were the two salient factors. “Our kids that did have EKG changes present had an average epilepsy duration of 73 months, as opposed to [the children] that did not have EKG changes and had an average epilepsy duration of 46 months,” said Dr. Bartlett.

Other factors, such epilepsy type, etiology, refractory epilepsy, and seizure frequency had no statistically significant association with EKG changes. They also saw no associations with high-risk seizure medications, even though some antiseizure drugs have been shown to be linked to EKG changes.

“We were able to confirm our hypothesis that EKG changes were more prevalent with longer duration of epilepsy. Unfortunately, we weren’t able to find any other clues that would help us counsel our patients, but this is part of a longitudinal prospective study that we’ll be following these kids over a couple of years’ time, so maybe we’ll be able to tease out some of these differences. Ideally, we’d be able to find some kind of a biomarker for future cardiovascular complications, and right now we’re working with some multivariable models to verify some of these findings,” said Dr. Bartlett.

Implications for clinical practice

During the Q&A, Dr. Bartlett was asked if all kids with epilepsy should undergo an EKG. She recommended against it for now. “At this point, I don’t think we have enough clear data to support getting an EKG on every kid with epilepsy. I do think it’s good practice to do them on all kids with channelopathies. As a general practice, I tend to have a low threshold towards many kids with epilepsy, but a lot of these cardiovascular risk factors tend to pop up more in adulthood, so it’s more preventative,” she said.

Grace Gombolay, MD, who moderated the session where the poster was presented, was asked for comment on the study. “What’s surprising about it is that up to half of patients actually had EKG changes, different what from what we see in normal population, and it’s interesting to think about the implications. One of the things that our epilepsy patients are at risk for is SUDEP – sudden, unexplained death in epilepsy. It’s interesting to think about what these EKG changes mean for clinical care. I think it’s too early to say at this time, but this might be one of those markers for SUDEP,” said Dr. Gombolay, who is an assistant professor at Emory University, Atlanta, and director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Children’s Healthcare of Atlanta.

The researchers prospectively studied 213 patients who were recruited. 46% were female, 42% were white, 41% were Hispanic, and 13% were African American. The mean age at enrollment was 116 months, and mean age of seizure onset was 45 months.

The researchers found that 47% had abnormal EKG readings. None of the changes were pathologic, but they may reflect changes to cardiac electrophysiology, according to Dr. Bartlett. Those with abnormal readings were older on average (11.6 vs. 8.3 years; P < .005) and had a longer epilepsy duration (73 vs. 46 months; P = .004).

Dr. Gombolay has no relevant financial disclosures.

Pediatric patients with epilepsy have an increased risk of cardiovascular complications later in life, but little is known about how they progress. A new study finds that abnormalities in electrocardiograms are linked to an earlier age of diagnosis and longer epilepsy duration.

The findings could help researchers in the search for biomarkers that could predict later problems in children with epilepsy. “In pediatric neurology I think we’re a little bit removed from some of the cardiovascular complications that can happen within epilepsy, but cardiovascular complications are well established, especially in adults that have epilepsy. Adults with epilepsy are more likely to have coronary artery disease, atherosclerosis, arrhythmias, heart attacks, and sudden cardiac death. It’s a pretty substantial difference compared with their nonepileptic peers. So knowing that, the big question is, how do these changes develop, and how do we really counsel our patients in regards to these complications?” said Brittnie Bartlett, MD, during her presentation of the research at the 2022 annual meeting of the Child Neurology Society.

Identifying factors that increase cardiac complications

Previous studies suggested that epilepsy duration might be linked to cardiovascular complications. In children with Dravet syndrome, epilepsy duration has been shown to be associated with cardiac complications. Pathological T wave alternans, which indicates ventricular instability, has been observed in adults with longstanding epilepsy but not adults with newly diagnosed epilepsy.

“So our question in this preliminary report of our data is: What factors in our general pediatric epilepsy cohort can we identify that put them at a greater risk for having EKG changes, and specifically, we wanted to verify these findings from the other studies that epilepsy duration is, in fact, a risk factor for these EKG changes in general [among children] with epilepsy aside from channelopathies,” said Dr. Bartlett, who is an assistant professor at Baylor College of Medicine and a child neurologist at Texas Children’s Hospital, both in Houston.

She presented a striking finding that cardiovascular changes appear early. “The most important thing I want you all to make note of is the fact that, in this baseline study that we got on these kids, 47% already had changes that we were seeing on their EKGs,” said Dr. Bartlett.

The researchers also looked for factors associated with EKG changes, and found that duration of epilepsy and age at diagnosis were the two salient factors. “Our kids that did have EKG changes present had an average epilepsy duration of 73 months, as opposed to [the children] that did not have EKG changes and had an average epilepsy duration of 46 months,” said Dr. Bartlett.

Other factors, such epilepsy type, etiology, refractory epilepsy, and seizure frequency had no statistically significant association with EKG changes. They also saw no associations with high-risk seizure medications, even though some antiseizure drugs have been shown to be linked to EKG changes.

“We were able to confirm our hypothesis that EKG changes were more prevalent with longer duration of epilepsy. Unfortunately, we weren’t able to find any other clues that would help us counsel our patients, but this is part of a longitudinal prospective study that we’ll be following these kids over a couple of years’ time, so maybe we’ll be able to tease out some of these differences. Ideally, we’d be able to find some kind of a biomarker for future cardiovascular complications, and right now we’re working with some multivariable models to verify some of these findings,” said Dr. Bartlett.

Implications for clinical practice

During the Q&A, Dr. Bartlett was asked if all kids with epilepsy should undergo an EKG. She recommended against it for now. “At this point, I don’t think we have enough clear data to support getting an EKG on every kid with epilepsy. I do think it’s good practice to do them on all kids with channelopathies. As a general practice, I tend to have a low threshold towards many kids with epilepsy, but a lot of these cardiovascular risk factors tend to pop up more in adulthood, so it’s more preventative,” she said.

Grace Gombolay, MD, who moderated the session where the poster was presented, was asked for comment on the study. “What’s surprising about it is that up to half of patients actually had EKG changes, different what from what we see in normal population, and it’s interesting to think about the implications. One of the things that our epilepsy patients are at risk for is SUDEP – sudden, unexplained death in epilepsy. It’s interesting to think about what these EKG changes mean for clinical care. I think it’s too early to say at this time, but this might be one of those markers for SUDEP,” said Dr. Gombolay, who is an assistant professor at Emory University, Atlanta, and director of the Pediatric Neuroimmunology and Multiple Sclerosis Clinic at Children’s Healthcare of Atlanta.

The researchers prospectively studied 213 patients who were recruited. 46% were female, 42% were white, 41% were Hispanic, and 13% were African American. The mean age at enrollment was 116 months, and mean age of seizure onset was 45 months.

The researchers found that 47% had abnormal EKG readings. None of the changes were pathologic, but they may reflect changes to cardiac electrophysiology, according to Dr. Bartlett. Those with abnormal readings were older on average (11.6 vs. 8.3 years; P < .005) and had a longer epilepsy duration (73 vs. 46 months; P = .004).

Dr. Gombolay has no relevant financial disclosures.