Pediatrics

The Centers for Disease Control and Prevention has issued a Health Alert Network (HAN) health advisory notifying clinicians and public health officials of a confirmed measles case in an individual who for 2 days (February 17-18) attended a large religious gathering that was attended by an estimated 20,000 people at Asbury University in Wilmore, Ky.

Given that large numbers of people might have been exposed to the attendee (who was not vaccinated) and that the individual had a history of recent international travel, the CDC has encouraged clinicians to be vigilant for patients presenting with symptoms that meet the measles case definition. A steady increase in measles cases from 49 in 2021 to 121 in 2022 in children who were not fully vaccinated – coupled with outbreaks in Ohio and Minnesota – underscores the potential gravity of the CDC advisory as well as the need to mitigate the risk of ongoing or secondary transmission.

Currently, little is known about the individual who contracted measles other than the fact that he is a resident of Jessamine County, Ky., according to a news release issued by the Kentucky Department of Public Health. It is the third confirmed case in Kentucky over the past 3 months. State and national health officials are concerned that the individual might have transmitted measles to attendees visiting from other states.

David Sugerman, MD, MPH, a medical officer in CDC’s division of viral diseases and lead for the measles, rubella, and cytomegalovirus team, noted that the timing of the alert coincides with the period in which persons who had had contact with the initial case patient might be expected to develop symptoms.

For clinicians, “It’s really about considering measles in any un- or undervaccinated patient that arrives at a clinic and recently traveled internationally,” Dr. Sugerman told this news organization. He explained that “when doctors are seeing patients, they’re not going to necessarily share that information off the bat when they present with fever or rash, or if their child has fever and rash, or that they traveled internationally. So, eliciting that history from the patient or their parents is really critical.”

The CDC recommends that measles be considered in anyone presenting with a febrile illness and symptoms that are clinically compatible with measles (that is, rash, cough, coryza, or conjunctivitis), as well as in patients who have recently traveled abroad, especially to countries with ongoing outbreaks, including India, Somalia, and Yemen.

“In general, if they’ve traveled internationally and they are undervaccinated, measles should be part of the differential diagnosis,” Sugerman said. He also emphasized the need to follow airborne isolation precautions in addition to general infection control measures.

Immediate triage is critical, especially since overcrowded waiting rooms might be filled with patients who are not yet eligible for vaccination or are not up to date or fully vaccinated.

“Measles is under airborne isolation criteria and precautions, and therefore, [patients] need to be placed as soon as possible into a negative pressure or airborne infection isolation room – and that should be a single room,” he explained. He noted, “In some settings, there may not be a negative pressure room, e.g., an outpatient pediatrics or family medicine office.”

Dr. Sugerman said that in these circumstances, patients should be placed in a room with masked health care providers who have received two doses of measles, mumps, and rubella (MMR) vaccine and that they should wear an N95 mask when entering the room and interviewing the patient.

Clinicians should follow CDC’s testing recommendations and collect a nasopharyngeal or throat swab or a urine specimen for PCR testing and a blood specimen for serology. In addition, they should immediately report cases to local and state public health authorities.

For all patients, it’s critical to be up to date on MMR vaccines, especially persons who are going to be traveling internationally. “We recommend that when they’ve got infants traveling with them who are 6-11 months of age, that they get a first dose (which we consider a zero dose), because they need a routine dose at 12-15 months, and then 4-6 years,” said Dr. Sugerman. He said that it’s safe for adults who are unsure of their status to receive an MMR dose as well.

Dr. Sugerman stressed that despite major strides, “we just don’t have enough coverage in all individuals in this country. Because people are traveling as often as they are, it can be imported. Until measles is eliminated globally, there’s going to be an ongoing risk of importation and potential spread amongst others in their household or community, especially amongst individuals who are not fully vaccinated and, in particular, amongst those who are unvaccinated,” he said.

Dr. Sugerman reports no relevant financial relationships.

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

The Centers for Disease Control and Prevention has issued a Health Alert Network (HAN) health advisory notifying clinicians and public health officials of a confirmed measles case in an individual who for 2 days (February 17-18) attended a large religious gathering that was attended by an estimated 20,000 people at Asbury University in Wilmore, Ky.

Given that large numbers of people might have been exposed to the attendee (who was not vaccinated) and that the individual had a history of recent international travel, the CDC has encouraged clinicians to be vigilant for patients presenting with symptoms that meet the measles case definition. A steady increase in measles cases from 49 in 2021 to 121 in 2022 in children who were not fully vaccinated – coupled with outbreaks in Ohio and Minnesota – underscores the potential gravity of the CDC advisory as well as the need to mitigate the risk of ongoing or secondary transmission.

Currently, little is known about the individual who contracted measles other than the fact that he is a resident of Jessamine County, Ky., according to a news release issued by the Kentucky Department of Public Health. It is the third confirmed case in Kentucky over the past 3 months. State and national health officials are concerned that the individual might have transmitted measles to attendees visiting from other states.

David Sugerman, MD, MPH, a medical officer in CDC’s division of viral diseases and lead for the measles, rubella, and cytomegalovirus team, noted that the timing of the alert coincides with the period in which persons who had had contact with the initial case patient might be expected to develop symptoms.

For clinicians, “It’s really about considering measles in any un- or undervaccinated patient that arrives at a clinic and recently traveled internationally,” Dr. Sugerman told this news organization. He explained that “when doctors are seeing patients, they’re not going to necessarily share that information off the bat when they present with fever or rash, or if their child has fever and rash, or that they traveled internationally. So, eliciting that history from the patient or their parents is really critical.”

The CDC recommends that measles be considered in anyone presenting with a febrile illness and symptoms that are clinically compatible with measles (that is, rash, cough, coryza, or conjunctivitis), as well as in patients who have recently traveled abroad, especially to countries with ongoing outbreaks, including India, Somalia, and Yemen.

“In general, if they’ve traveled internationally and they are undervaccinated, measles should be part of the differential diagnosis,” Sugerman said. He also emphasized the need to follow airborne isolation precautions in addition to general infection control measures.

Immediate triage is critical, especially since overcrowded waiting rooms might be filled with patients who are not yet eligible for vaccination or are not up to date or fully vaccinated.

“Measles is under airborne isolation criteria and precautions, and therefore, [patients] need to be placed as soon as possible into a negative pressure or airborne infection isolation room – and that should be a single room,” he explained. He noted, “In some settings, there may not be a negative pressure room, e.g., an outpatient pediatrics or family medicine office.”

Dr. Sugerman said that in these circumstances, patients should be placed in a room with masked health care providers who have received two doses of measles, mumps, and rubella (MMR) vaccine and that they should wear an N95 mask when entering the room and interviewing the patient.

Clinicians should follow CDC’s testing recommendations and collect a nasopharyngeal or throat swab or a urine specimen for PCR testing and a blood specimen for serology. In addition, they should immediately report cases to local and state public health authorities.

For all patients, it’s critical to be up to date on MMR vaccines, especially persons who are going to be traveling internationally. “We recommend that when they’ve got infants traveling with them who are 6-11 months of age, that they get a first dose (which we consider a zero dose), because they need a routine dose at 12-15 months, and then 4-6 years,” said Dr. Sugerman. He said that it’s safe for adults who are unsure of their status to receive an MMR dose as well.

Dr. Sugerman stressed that despite major strides, “we just don’t have enough coverage in all individuals in this country. Because people are traveling as often as they are, it can be imported. Until measles is eliminated globally, there’s going to be an ongoing risk of importation and potential spread amongst others in their household or community, especially amongst individuals who are not fully vaccinated and, in particular, amongst those who are unvaccinated,” he said.

Dr. Sugerman reports no relevant financial relationships.

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

The Centers for Disease Control and Prevention has issued a Health Alert Network (HAN) health advisory notifying clinicians and public health officials of a confirmed measles case in an individual who for 2 days (February 17-18) attended a large religious gathering that was attended by an estimated 20,000 people at Asbury University in Wilmore, Ky.

Given that large numbers of people might have been exposed to the attendee (who was not vaccinated) and that the individual had a history of recent international travel, the CDC has encouraged clinicians to be vigilant for patients presenting with symptoms that meet the measles case definition. A steady increase in measles cases from 49 in 2021 to 121 in 2022 in children who were not fully vaccinated – coupled with outbreaks in Ohio and Minnesota – underscores the potential gravity of the CDC advisory as well as the need to mitigate the risk of ongoing or secondary transmission.

Currently, little is known about the individual who contracted measles other than the fact that he is a resident of Jessamine County, Ky., according to a news release issued by the Kentucky Department of Public Health. It is the third confirmed case in Kentucky over the past 3 months. State and national health officials are concerned that the individual might have transmitted measles to attendees visiting from other states.

David Sugerman, MD, MPH, a medical officer in CDC’s division of viral diseases and lead for the measles, rubella, and cytomegalovirus team, noted that the timing of the alert coincides with the period in which persons who had had contact with the initial case patient might be expected to develop symptoms.

For clinicians, “It’s really about considering measles in any un- or undervaccinated patient that arrives at a clinic and recently traveled internationally,” Dr. Sugerman told this news organization. He explained that “when doctors are seeing patients, they’re not going to necessarily share that information off the bat when they present with fever or rash, or if their child has fever and rash, or that they traveled internationally. So, eliciting that history from the patient or their parents is really critical.”

The CDC recommends that measles be considered in anyone presenting with a febrile illness and symptoms that are clinically compatible with measles (that is, rash, cough, coryza, or conjunctivitis), as well as in patients who have recently traveled abroad, especially to countries with ongoing outbreaks, including India, Somalia, and Yemen.

“In general, if they’ve traveled internationally and they are undervaccinated, measles should be part of the differential diagnosis,” Sugerman said. He also emphasized the need to follow airborne isolation precautions in addition to general infection control measures.

Immediate triage is critical, especially since overcrowded waiting rooms might be filled with patients who are not yet eligible for vaccination or are not up to date or fully vaccinated.

“Measles is under airborne isolation criteria and precautions, and therefore, [patients] need to be placed as soon as possible into a negative pressure or airborne infection isolation room – and that should be a single room,” he explained. He noted, “In some settings, there may not be a negative pressure room, e.g., an outpatient pediatrics or family medicine office.”

Dr. Sugerman said that in these circumstances, patients should be placed in a room with masked health care providers who have received two doses of measles, mumps, and rubella (MMR) vaccine and that they should wear an N95 mask when entering the room and interviewing the patient.

Clinicians should follow CDC’s testing recommendations and collect a nasopharyngeal or throat swab or a urine specimen for PCR testing and a blood specimen for serology. In addition, they should immediately report cases to local and state public health authorities.

For all patients, it’s critical to be up to date on MMR vaccines, especially persons who are going to be traveling internationally. “We recommend that when they’ve got infants traveling with them who are 6-11 months of age, that they get a first dose (which we consider a zero dose), because they need a routine dose at 12-15 months, and then 4-6 years,” said Dr. Sugerman. He said that it’s safe for adults who are unsure of their status to receive an MMR dose as well.

Dr. Sugerman stressed that despite major strides, “we just don’t have enough coverage in all individuals in this country. Because people are traveling as often as they are, it can be imported. Until measles is eliminated globally, there’s going to be an ongoing risk of importation and potential spread amongst others in their household or community, especially amongst individuals who are not fully vaccinated and, in particular, amongst those who are unvaccinated,” he said.

Dr. Sugerman reports no relevant financial relationships.

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

More than 1 in 4 parents lied to school officials about their children’s COVID-19 status or refused to comply with public health rules during the height of the pandemic, a new study found. Researchers said they suspected the 26% of parents who misrepresented their children’s health status may have undercounted the actual figure.

“If anything, 26% is probably the minimum” of parents who misled school officials, said Angela Fagerlin, PhD, a researcher at the University of Utah Medical School, Salt Lake City.

In the survey, many parents said they considered it their right as parents to make their own decision about their children’s health status, said Dr. Fagerlin, who is also the chair of the department of population health sciences at the University of Utah School of Medicine. 

“It appears that many parents were concerned about their children missing school,” she said. “At the same time, they’re potentially exposing other kids to a serious illness.”

In the survey, parents were asked whether they lied or misrepresented information about their children on seven different COVID-19 topics, including illness and vaccination status and if they followed quarantine protocols. Researchers tallied survey responses collected in December 2021 from 580 parents, whose average age was 36 and of whom 70% were women. Results were published in the journal JAMA Network Open.

Overall, 24% of parents said they lied to people that their children were with while knowing or suspecting the children had COVID. About half of parents cited at least one of the following reasons for doing so: parental freedom, child did not feel very sick, or wanted the child’s life to feel “normal.”

About 20% of parents said they avoided testing when they thought their child had COVID, and parents also reported allowing children to break quarantine rules at a similar rate. More than half of parents who avoided testing said they were worried testing would hurt or feel uncomfortable.

About 4 in 10 parents who lied about their child’s illness status or who lied about whether their child should be in quarantine said they did so because of guidance from a public figure such as a celebrity or politician. At least 3 in 10 said they lied because they could not miss work to stay home with their child.

“We need to do a better job of providing support mechanisms like paid sick leave for family illness so that parents don’t feel like their only option is to engage in misrepresentation or non-adherence to public health guidelines during a future infectious disease outbreak that matches or exceeds the magnitude of COVID-19,” says researcher Andrea Gurmankin Levy, PhD, of Middlesex (Conn.) Community College.

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

More than 1 in 4 parents lied to school officials about their children’s COVID-19 status or refused to comply with public health rules during the height of the pandemic, a new study found. Researchers said they suspected the 26% of parents who misrepresented their children’s health status may have undercounted the actual figure.

“If anything, 26% is probably the minimum” of parents who misled school officials, said Angela Fagerlin, PhD, a researcher at the University of Utah Medical School, Salt Lake City.

In the survey, many parents said they considered it their right as parents to make their own decision about their children’s health status, said Dr. Fagerlin, who is also the chair of the department of population health sciences at the University of Utah School of Medicine. 

“It appears that many parents were concerned about their children missing school,” she said. “At the same time, they’re potentially exposing other kids to a serious illness.”

In the survey, parents were asked whether they lied or misrepresented information about their children on seven different COVID-19 topics, including illness and vaccination status and if they followed quarantine protocols. Researchers tallied survey responses collected in December 2021 from 580 parents, whose average age was 36 and of whom 70% were women. Results were published in the journal JAMA Network Open.

Overall, 24% of parents said they lied to people that their children were with while knowing or suspecting the children had COVID. About half of parents cited at least one of the following reasons for doing so: parental freedom, child did not feel very sick, or wanted the child’s life to feel “normal.”

About 20% of parents said they avoided testing when they thought their child had COVID, and parents also reported allowing children to break quarantine rules at a similar rate. More than half of parents who avoided testing said they were worried testing would hurt or feel uncomfortable.

About 4 in 10 parents who lied about their child’s illness status or who lied about whether their child should be in quarantine said they did so because of guidance from a public figure such as a celebrity or politician. At least 3 in 10 said they lied because they could not miss work to stay home with their child.

“We need to do a better job of providing support mechanisms like paid sick leave for family illness so that parents don’t feel like their only option is to engage in misrepresentation or non-adherence to public health guidelines during a future infectious disease outbreak that matches or exceeds the magnitude of COVID-19,” says researcher Andrea Gurmankin Levy, PhD, of Middlesex (Conn.) Community College.

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

More than 1 in 4 parents lied to school officials about their children’s COVID-19 status or refused to comply with public health rules during the height of the pandemic, a new study found. Researchers said they suspected the 26% of parents who misrepresented their children’s health status may have undercounted the actual figure.

“If anything, 26% is probably the minimum” of parents who misled school officials, said Angela Fagerlin, PhD, a researcher at the University of Utah Medical School, Salt Lake City.

In the survey, many parents said they considered it their right as parents to make their own decision about their children’s health status, said Dr. Fagerlin, who is also the chair of the department of population health sciences at the University of Utah School of Medicine. 

“It appears that many parents were concerned about their children missing school,” she said. “At the same time, they’re potentially exposing other kids to a serious illness.”

In the survey, parents were asked whether they lied or misrepresented information about their children on seven different COVID-19 topics, including illness and vaccination status and if they followed quarantine protocols. Researchers tallied survey responses collected in December 2021 from 580 parents, whose average age was 36 and of whom 70% were women. Results were published in the journal JAMA Network Open.

Overall, 24% of parents said they lied to people that their children were with while knowing or suspecting the children had COVID. About half of parents cited at least one of the following reasons for doing so: parental freedom, child did not feel very sick, or wanted the child’s life to feel “normal.”

About 20% of parents said they avoided testing when they thought their child had COVID, and parents also reported allowing children to break quarantine rules at a similar rate. More than half of parents who avoided testing said they were worried testing would hurt or feel uncomfortable.

About 4 in 10 parents who lied about their child’s illness status or who lied about whether their child should be in quarantine said they did so because of guidance from a public figure such as a celebrity or politician. At least 3 in 10 said they lied because they could not miss work to stay home with their child.

“We need to do a better job of providing support mechanisms like paid sick leave for family illness so that parents don’t feel like their only option is to engage in misrepresentation or non-adherence to public health guidelines during a future infectious disease outbreak that matches or exceeds the magnitude of COVID-19,” says researcher Andrea Gurmankin Levy, PhD, of Middlesex (Conn.) Community College.

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

Children and young adults with inflammatory bowel disease (IBD) are about 2.5 times more likely to develop posttraumatic stress disorder (PTSD), almost twice as likely to report an eating disorder, and 1.5 times more likely to engage in self-harm, a new U.K. study suggests.

The retrospective, observational study of young people with IBD versus those without assessed the incidence of a wide range of mental health conditions in people aged 5-25 years.

“Anxiety and depression will not be a surprise to most of us. But we also saw changes for eating disorders, PTSD, and sleep changes,” said Richard K. Russell, MD, a pediatric gastroenterologist at the Royal Hospital for Sick Children, Edinburgh.

Dr. Russell presented the research at the annual congress of the European Crohn’s and Colitis Organisation, held in Copenhagen and virtually.

The findings indicate an unmet need for mental health care for young patients with IBD, he said. “All of us at ECCO need to address this gap.”
 

Key findings

Dr. Russell and colleagues identified 3,898 young people diagnosed with IBD in the 10-year period Jan. 1, 2010, through Jan. 1, 2020, using the Optimum Patient Care Research Database, which includes de-identified data from more than 1,000 general practices across the United Kingdom. They used propensity score matching to create a control group of 15,571 people without IBD, controlling for age, sex, socioeconomic status, ethnicity, and health conditions other than IBD.

Median follow-up was about 3 years.

The cumulative lifetime risk for developing any mental health condition by age 25 was 31.1% in the IBD group versus 25.1% in controls, a statistically significant difference.

Compared with the control group, the people with incident IBD were significantly more likely to develop the following:

• PTSD.
• Eating disorders.
• Self-harm.
• Sleep disturbance.
• Depression.
• Anxiety disorder.
• ‘Any mental health condition.’

Those most are risk included males overall, and specifically boys aged 12-17 years. Those with Crohn’s disease versus other types of IBD were also most at risk.

In a subgroup analysis, presented as a poster at the meeting, Dr. Russell and colleagues also found that mental health comorbidity in children and young adults with IBD is associated with increased IBD symptoms and health care utilization, as well as time off work.

Children and young adults with both IBD and mental health conditions should be monitored and receive appropriate mental health support as part of their multidisciplinary care, Dr. Russell said.

Dr. Russell added that the study period ended a few months before the COVID-19 pandemic began, so the research does not reflect its impact on mental health in the study population.

“The number of children and young adults we’re seeing in our clinic with mental health issues has rocketed through the roof because of the pandemic,” he said.

Dr. Russell suggested that the organization create a psychology subgroup called Proactive Psychologists of ECCO, or Prosecco for short.
 

Clinical implications

The study is important for highlighting the increased burden of mental health problems in young people with IBD, said session comoderator Nick Kennedy, MD, a consultant gastroenterologist and chief research information officer with the Royal Devon University Healthcare NHS Foundation Trust in England.

Dr. Kennedy, who was not affiliated with the research, is also supportive of the idea of a psychological subgroup within ECCO.

The peak age for developing mental health disorders found by the study (12-17 years) “is a unique and very sensitive time,” said Sara Mesilhy, MBBS, a gastroenterologist with the Royal College of Physicians in London.

“These results highlight the need for development of early screening psychiatric programs starting from time of diagnosis and continuing on periodic intervals to offer the best management plan for IBD patients, especially those with childhood-onset IBD,” said Dr. Mesilhy, who was not affiliated with the research.

Such programs would “improve the patient’s quality of life, protecting them from a lot of suffering and preventing the bad sequelae for these disorders,” said Dr. Mesilhy. “Moreover, we still need further studies to identify the most efficient monitoring and treatment protocols.”

Dr. Kennedy applauded the researchers for conducting a population-based study because it ensured an adequate cohort size and maximized identification of mental health disorders.

“It was interesting to see that there were a range of conditions where risk was increased, and that males with IBD were at particularly increased risk,” he added.

Researchers’ use of coded primary care data was a study limitation, but it was “appropriately acknowledged by the presenter,” Dr. Kennedy said.

The study was supported by Pfizer. Dr. Russell disclosed he is a consultant and member of a speakers’ bureau for Pfizer outside the submitted work. Dr. Kennedy and Dr. Mesilhy report no relevant financial relationships.

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

Children and young adults with inflammatory bowel disease (IBD) are about 2.5 times more likely to develop posttraumatic stress disorder (PTSD), almost twice as likely to report an eating disorder, and 1.5 times more likely to engage in self-harm, a new U.K. study suggests.

The retrospective, observational study of young people with IBD versus those without assessed the incidence of a wide range of mental health conditions in people aged 5-25 years.

“Anxiety and depression will not be a surprise to most of us. But we also saw changes for eating disorders, PTSD, and sleep changes,” said Richard K. Russell, MD, a pediatric gastroenterologist at the Royal Hospital for Sick Children, Edinburgh.

Dr. Russell presented the research at the annual congress of the European Crohn’s and Colitis Organisation, held in Copenhagen and virtually.

The findings indicate an unmet need for mental health care for young patients with IBD, he said. “All of us at ECCO need to address this gap.”
 

Key findings

Dr. Russell and colleagues identified 3,898 young people diagnosed with IBD in the 10-year period Jan. 1, 2010, through Jan. 1, 2020, using the Optimum Patient Care Research Database, which includes de-identified data from more than 1,000 general practices across the United Kingdom. They used propensity score matching to create a control group of 15,571 people without IBD, controlling for age, sex, socioeconomic status, ethnicity, and health conditions other than IBD.

Median follow-up was about 3 years.

The cumulative lifetime risk for developing any mental health condition by age 25 was 31.1% in the IBD group versus 25.1% in controls, a statistically significant difference.

Compared with the control group, the people with incident IBD were significantly more likely to develop the following:

• PTSD.
• Eating disorders.
• Self-harm.
• Sleep disturbance.
• Depression.
• Anxiety disorder.
• ‘Any mental health condition.’

Those most are risk included males overall, and specifically boys aged 12-17 years. Those with Crohn’s disease versus other types of IBD were also most at risk.

In a subgroup analysis, presented as a poster at the meeting, Dr. Russell and colleagues also found that mental health comorbidity in children and young adults with IBD is associated with increased IBD symptoms and health care utilization, as well as time off work.

Children and young adults with both IBD and mental health conditions should be monitored and receive appropriate mental health support as part of their multidisciplinary care, Dr. Russell said.

Dr. Russell added that the study period ended a few months before the COVID-19 pandemic began, so the research does not reflect its impact on mental health in the study population.

“The number of children and young adults we’re seeing in our clinic with mental health issues has rocketed through the roof because of the pandemic,” he said.

Dr. Russell suggested that the organization create a psychology subgroup called Proactive Psychologists of ECCO, or Prosecco for short.
 

Clinical implications

The study is important for highlighting the increased burden of mental health problems in young people with IBD, said session comoderator Nick Kennedy, MD, a consultant gastroenterologist and chief research information officer with the Royal Devon University Healthcare NHS Foundation Trust in England.

Dr. Kennedy, who was not affiliated with the research, is also supportive of the idea of a psychological subgroup within ECCO.

The peak age for developing mental health disorders found by the study (12-17 years) “is a unique and very sensitive time,” said Sara Mesilhy, MBBS, a gastroenterologist with the Royal College of Physicians in London.

“These results highlight the need for development of early screening psychiatric programs starting from time of diagnosis and continuing on periodic intervals to offer the best management plan for IBD patients, especially those with childhood-onset IBD,” said Dr. Mesilhy, who was not affiliated with the research.

Such programs would “improve the patient’s quality of life, protecting them from a lot of suffering and preventing the bad sequelae for these disorders,” said Dr. Mesilhy. “Moreover, we still need further studies to identify the most efficient monitoring and treatment protocols.”

Dr. Kennedy applauded the researchers for conducting a population-based study because it ensured an adequate cohort size and maximized identification of mental health disorders.

“It was interesting to see that there were a range of conditions where risk was increased, and that males with IBD were at particularly increased risk,” he added.

Researchers’ use of coded primary care data was a study limitation, but it was “appropriately acknowledged by the presenter,” Dr. Kennedy said.

The study was supported by Pfizer. Dr. Russell disclosed he is a consultant and member of a speakers’ bureau for Pfizer outside the submitted work. Dr. Kennedy and Dr. Mesilhy report no relevant financial relationships.

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

Children and young adults with inflammatory bowel disease (IBD) are about 2.5 times more likely to develop posttraumatic stress disorder (PTSD), almost twice as likely to report an eating disorder, and 1.5 times more likely to engage in self-harm, a new U.K. study suggests.

The retrospective, observational study of young people with IBD versus those without assessed the incidence of a wide range of mental health conditions in people aged 5-25 years.

“Anxiety and depression will not be a surprise to most of us. But we also saw changes for eating disorders, PTSD, and sleep changes,” said Richard K. Russell, MD, a pediatric gastroenterologist at the Royal Hospital for Sick Children, Edinburgh.

Dr. Russell presented the research at the annual congress of the European Crohn’s and Colitis Organisation, held in Copenhagen and virtually.

The findings indicate an unmet need for mental health care for young patients with IBD, he said. “All of us at ECCO need to address this gap.”
 

Key findings

Dr. Russell and colleagues identified 3,898 young people diagnosed with IBD in the 10-year period Jan. 1, 2010, through Jan. 1, 2020, using the Optimum Patient Care Research Database, which includes de-identified data from more than 1,000 general practices across the United Kingdom. They used propensity score matching to create a control group of 15,571 people without IBD, controlling for age, sex, socioeconomic status, ethnicity, and health conditions other than IBD.

Median follow-up was about 3 years.

The cumulative lifetime risk for developing any mental health condition by age 25 was 31.1% in the IBD group versus 25.1% in controls, a statistically significant difference.

Compared with the control group, the people with incident IBD were significantly more likely to develop the following:

• PTSD.
• Eating disorders.
• Self-harm.
• Sleep disturbance.
• Depression.
• Anxiety disorder.
• ‘Any mental health condition.’

Those most are risk included males overall, and specifically boys aged 12-17 years. Those with Crohn’s disease versus other types of IBD were also most at risk.

In a subgroup analysis, presented as a poster at the meeting, Dr. Russell and colleagues also found that mental health comorbidity in children and young adults with IBD is associated with increased IBD symptoms and health care utilization, as well as time off work.

Children and young adults with both IBD and mental health conditions should be monitored and receive appropriate mental health support as part of their multidisciplinary care, Dr. Russell said.

Dr. Russell added that the study period ended a few months before the COVID-19 pandemic began, so the research does not reflect its impact on mental health in the study population.

“The number of children and young adults we’re seeing in our clinic with mental health issues has rocketed through the roof because of the pandemic,” he said.

Dr. Russell suggested that the organization create a psychology subgroup called Proactive Psychologists of ECCO, or Prosecco for short.
 

Clinical implications

The study is important for highlighting the increased burden of mental health problems in young people with IBD, said session comoderator Nick Kennedy, MD, a consultant gastroenterologist and chief research information officer with the Royal Devon University Healthcare NHS Foundation Trust in England.

Dr. Kennedy, who was not affiliated with the research, is also supportive of the idea of a psychological subgroup within ECCO.

The peak age for developing mental health disorders found by the study (12-17 years) “is a unique and very sensitive time,” said Sara Mesilhy, MBBS, a gastroenterologist with the Royal College of Physicians in London.

“These results highlight the need for development of early screening psychiatric programs starting from time of diagnosis and continuing on periodic intervals to offer the best management plan for IBD patients, especially those with childhood-onset IBD,” said Dr. Mesilhy, who was not affiliated with the research.

Such programs would “improve the patient’s quality of life, protecting them from a lot of suffering and preventing the bad sequelae for these disorders,” said Dr. Mesilhy. “Moreover, we still need further studies to identify the most efficient monitoring and treatment protocols.”

Dr. Kennedy applauded the researchers for conducting a population-based study because it ensured an adequate cohort size and maximized identification of mental health disorders.

“It was interesting to see that there were a range of conditions where risk was increased, and that males with IBD were at particularly increased risk,” he added.

Researchers’ use of coded primary care data was a study limitation, but it was “appropriately acknowledged by the presenter,” Dr. Kennedy said.

The study was supported by Pfizer. Dr. Russell disclosed he is a consultant and member of a speakers’ bureau for Pfizer outside the submitted work. Dr. Kennedy and Dr. Mesilhy report no relevant financial relationships.

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

The Food and Drug Administration has accepted a new drug application for berdazimer gel 10.3% for the treatment of molluscum contagiosum, the manufacturer announced on March 7.

If approved, berdazimer gel would be the first FDA-approved prescription product for molluscum contagiosum in the United States, according to the company, Novan. The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a novel nitric oxide–releasing agent.

Molluscum contagiosum is a benign but contagious skin infection characterized by red papules on the face, trunk, limbs, and axillae that may persist for years if left untreated.

The treatment was evaluated in the B-SIMPLE4 study, a phase 3 clinical trial including 891 individuals with molluscum contagiosum aged 6 months and older, with 3-70 raised lesions The mean age of the patients was approximately 7 years (range, 0.9-47.5 years) and 85.5% were White (4.7% were Black, 21.2% were Hispanic, and 1.4% were Asian). Study participants were randomized to berdazimer gel 10.3% or a vehicle gel applied as a thin layer to all lesions once daily for 12 weeks.

The full results of the B-SIMPLE4 study were published in JAMA Dermatology in July 2022. After 12 weeks of treatment, 32.4% of patients in the berdazimer group met the primary outcome of complete clearance of all lesions, versus 19.7% of those on the vehicle (P < .001). The rates of adverse events were similar and low in both groups. The most common adverse events in both groups were application-site pain and erythema, and most cases were mild or moderate. A total of 4.1% of berdazimer patients and 0.7% of placebo patients experienced adverse events that prompted treatment discontinuation.

The Prescription Drug User Fee goal date for the approval of berdazimer 10.3% for molluscum contagiosum is set for Jan. 5, 2024, according to Novan.

The Food and Drug Administration has accepted a new drug application for berdazimer gel 10.3% for the treatment of molluscum contagiosum, the manufacturer announced on March 7.

If approved, berdazimer gel would be the first FDA-approved prescription product for molluscum contagiosum in the United States, according to the company, Novan. The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a novel nitric oxide–releasing agent.

Molluscum contagiosum is a benign but contagious skin infection characterized by red papules on the face, trunk, limbs, and axillae that may persist for years if left untreated.

The treatment was evaluated in the B-SIMPLE4 study, a phase 3 clinical trial including 891 individuals with molluscum contagiosum aged 6 months and older, with 3-70 raised lesions The mean age of the patients was approximately 7 years (range, 0.9-47.5 years) and 85.5% were White (4.7% were Black, 21.2% were Hispanic, and 1.4% were Asian). Study participants were randomized to berdazimer gel 10.3% or a vehicle gel applied as a thin layer to all lesions once daily for 12 weeks.

The full results of the B-SIMPLE4 study were published in JAMA Dermatology in July 2022. After 12 weeks of treatment, 32.4% of patients in the berdazimer group met the primary outcome of complete clearance of all lesions, versus 19.7% of those on the vehicle (P < .001). The rates of adverse events were similar and low in both groups. The most common adverse events in both groups were application-site pain and erythema, and most cases were mild or moderate. A total of 4.1% of berdazimer patients and 0.7% of placebo patients experienced adverse events that prompted treatment discontinuation.

The Prescription Drug User Fee goal date for the approval of berdazimer 10.3% for molluscum contagiosum is set for Jan. 5, 2024, according to Novan.

The Food and Drug Administration has accepted a new drug application for berdazimer gel 10.3% for the treatment of molluscum contagiosum, the manufacturer announced on March 7.

If approved, berdazimer gel would be the first FDA-approved prescription product for molluscum contagiosum in the United States, according to the company, Novan. The active ingredient in berdazimer gel 10.3% is berdazimer sodium, a novel nitric oxide–releasing agent.

Molluscum contagiosum is a benign but contagious skin infection characterized by red papules on the face, trunk, limbs, and axillae that may persist for years if left untreated.

The treatment was evaluated in the B-SIMPLE4 study, a phase 3 clinical trial including 891 individuals with molluscum contagiosum aged 6 months and older, with 3-70 raised lesions The mean age of the patients was approximately 7 years (range, 0.9-47.5 years) and 85.5% were White (4.7% were Black, 21.2% were Hispanic, and 1.4% were Asian). Study participants were randomized to berdazimer gel 10.3% or a vehicle gel applied as a thin layer to all lesions once daily for 12 weeks.

The full results of the B-SIMPLE4 study were published in JAMA Dermatology in July 2022. After 12 weeks of treatment, 32.4% of patients in the berdazimer group met the primary outcome of complete clearance of all lesions, versus 19.7% of those on the vehicle (P < .001). The rates of adverse events were similar and low in both groups. The most common adverse events in both groups were application-site pain and erythema, and most cases were mild or moderate. A total of 4.1% of berdazimer patients and 0.7% of placebo patients experienced adverse events that prompted treatment discontinuation.

The Prescription Drug User Fee goal date for the approval of berdazimer 10.3% for molluscum contagiosum is set for Jan. 5, 2024, according to Novan.

Children who suffer from persistent bad dreams may be at increased risk for cognitive impairment or Parkinson’s disease (PD) later in life, new research shows.

Compared with children who never had distressing dreams between ages 7 and 11 years, those who had persistent distressing dreams were 76% more likely to develop cognitive impairment and roughly seven times more likely to develop PD by age 50 years.

It’s been shown previously that sleep problems in adulthood, including distressing dreams, can precede the onset of neurodegenerative diseases such as Alzheimer’s disease (AD) or PD by several years, and in some cases decades, study investigator Abidemi Otaiku, BMBS, University of Birmingham (England), told this news organization.

However, no studies have investigated whether distressing dreams during childhood might also be associated with increased risk for cognitive decline or PD.

“As such, these findings provide evidence for the first time that certain sleep problems in childhood (having regular distressing dreams) could be an early indicator of increased dementia and PD risk,” Dr. Otaiku said.

He noted that the findings build on previous studies which showed that regular nightmares in childhood could be an early indicator for psychiatric problems in adolescence, such as borderline personality disorder, attention-deficit/hyperactivity disorder, and psychosis.

The study was published online February 26 in The Lancet journal eClinicalMedicine.

Statistically significant

The prospective, longitudinal analysis used data from the 1958 British Birth Cohort Study, a prospective birth cohort which included all people born in Britain during a single week in 1958.

At age 7 years (in 1965) and 11 years (in 1969), mothers were asked to report whether their child experienced “bad dreams or night terrors” in the past 3 months, and cognitive impairment and PD were determined at age 50 (2008).

Among a total of 6,991 children (51% girls), 78.2% never had distressing dreams, 17.9% had transient distressing dreams (either at ages 7 or 11 years), and 3.8% had persistent distressing dreams (at both ages 7 and 11 years).

By age 50, 262 participants had developed cognitive impairment, and five had been diagnosed with PD.

After adjusting for all covariates, having more regular distressing dreams during childhood was “linearly and statistically significantly” associated with higher risk of developing cognitive impairment or PD by age 50 years (P = .037). This was the case in both boys and girls.

Compared with children who never had bad dreams, peers who had persistent distressing dreams (at ages 7 and 11 years) had an 85% increased risk for cognitive impairment or PD by age 50 (adjusted odds ratio, 1.85; 95% confidence interval, 1.10-3.11; P = .019).

The associations remained when incident cognitive impairment and incident PD were analyzed separately.

Compared with children who never had distressing dreams, children who had persistent distressing dreams were 76% more likely to develop cognitive impairment by age 50 years (aOR, 1.76; 95% CI, 1.03-2.99; P = .037), and were about seven times more likely to be diagnosed with PD by age 50 years (aOR, 7.35; 95% CI, 1.03-52.73; P = .047).

The linear association was statistically significant for PD (P = .050) and had a trend toward statistical significance for cognitive impairment (P = .074).

Mechanism unclear

“Early-life nightmares might be causally associated with cognitive impairment and PD, noncausally associated with cognitive impairment and PD, or both. At this stage it remains unclear which of the three options is correct. Therefore, further research on mechanisms is needed,” Dr. Otaiku told this news organization.

“One plausible noncausal explanation is that there are shared genetic factors which predispose individuals to having frequent nightmares in childhood, and to developing neurodegenerative diseases such as AD or PD in adulthood,” he added.

It’s also plausible that having regular nightmares throughout childhood could be a causal risk factor for cognitive impairment and PD by causing chronic sleep disruption, he noted.

“Chronic sleep disruption due to nightmares might lead to impaired glymphatic clearance during sleep – and thus greater accumulation of pathological proteins in the brain, such as amyloid-beta and alpha-synuclein,” Dr. Otaiku said.

Disrupted sleep throughout childhood might also impair normal brain development, which could make children’s brains less resilient to neuropathologic damage, he said.

Clinical implications?

There are established treatments for childhood nightmares, including nonpharmacologic approaches.

“For children who have regular nightmares that lead to impaired daytime functioning, it may well be a good idea for them to see a sleep physician to discuss whether treatment may be needed,” Dr. Otaiku said.

But should doctors treat children with persistent nightmares for the purpose of preventing neurodegenerative diseases in adulthood or psychiatric problems in adolescence?

“It’s an interesting possibility. However, more research is needed to confirm these epidemiological associations and to determine whether or not nightmares are a causal risk factor for these conditions,” Dr. Otaiku concluded.

The study received no external funding. Dr. Otaiku reports no relevant disclosures.

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

Children who suffer from persistent bad dreams may be at increased risk for cognitive impairment or Parkinson’s disease (PD) later in life, new research shows.

Compared with children who never had distressing dreams between ages 7 and 11 years, those who had persistent distressing dreams were 76% more likely to develop cognitive impairment and roughly seven times more likely to develop PD by age 50 years.

It’s been shown previously that sleep problems in adulthood, including distressing dreams, can precede the onset of neurodegenerative diseases such as Alzheimer’s disease (AD) or PD by several years, and in some cases decades, study investigator Abidemi Otaiku, BMBS, University of Birmingham (England), told this news organization.

However, no studies have investigated whether distressing dreams during childhood might also be associated with increased risk for cognitive decline or PD.

“As such, these findings provide evidence for the first time that certain sleep problems in childhood (having regular distressing dreams) could be an early indicator of increased dementia and PD risk,” Dr. Otaiku said.

He noted that the findings build on previous studies which showed that regular nightmares in childhood could be an early indicator for psychiatric problems in adolescence, such as borderline personality disorder, attention-deficit/hyperactivity disorder, and psychosis.

The study was published online February 26 in The Lancet journal eClinicalMedicine.

Statistically significant

The prospective, longitudinal analysis used data from the 1958 British Birth Cohort Study, a prospective birth cohort which included all people born in Britain during a single week in 1958.

At age 7 years (in 1965) and 11 years (in 1969), mothers were asked to report whether their child experienced “bad dreams or night terrors” in the past 3 months, and cognitive impairment and PD were determined at age 50 (2008).

Among a total of 6,991 children (51% girls), 78.2% never had distressing dreams, 17.9% had transient distressing dreams (either at ages 7 or 11 years), and 3.8% had persistent distressing dreams (at both ages 7 and 11 years).

By age 50, 262 participants had developed cognitive impairment, and five had been diagnosed with PD.

After adjusting for all covariates, having more regular distressing dreams during childhood was “linearly and statistically significantly” associated with higher risk of developing cognitive impairment or PD by age 50 years (P = .037). This was the case in both boys and girls.

Compared with children who never had bad dreams, peers who had persistent distressing dreams (at ages 7 and 11 years) had an 85% increased risk for cognitive impairment or PD by age 50 (adjusted odds ratio, 1.85; 95% confidence interval, 1.10-3.11; P = .019).

The associations remained when incident cognitive impairment and incident PD were analyzed separately.

Compared with children who never had distressing dreams, children who had persistent distressing dreams were 76% more likely to develop cognitive impairment by age 50 years (aOR, 1.76; 95% CI, 1.03-2.99; P = .037), and were about seven times more likely to be diagnosed with PD by age 50 years (aOR, 7.35; 95% CI, 1.03-52.73; P = .047).

The linear association was statistically significant for PD (P = .050) and had a trend toward statistical significance for cognitive impairment (P = .074).

Mechanism unclear

“Early-life nightmares might be causally associated with cognitive impairment and PD, noncausally associated with cognitive impairment and PD, or both. At this stage it remains unclear which of the three options is correct. Therefore, further research on mechanisms is needed,” Dr. Otaiku told this news organization.

“One plausible noncausal explanation is that there are shared genetic factors which predispose individuals to having frequent nightmares in childhood, and to developing neurodegenerative diseases such as AD or PD in adulthood,” he added.

It’s also plausible that having regular nightmares throughout childhood could be a causal risk factor for cognitive impairment and PD by causing chronic sleep disruption, he noted.

“Chronic sleep disruption due to nightmares might lead to impaired glymphatic clearance during sleep – and thus greater accumulation of pathological proteins in the brain, such as amyloid-beta and alpha-synuclein,” Dr. Otaiku said.

Disrupted sleep throughout childhood might also impair normal brain development, which could make children’s brains less resilient to neuropathologic damage, he said.

Clinical implications?

There are established treatments for childhood nightmares, including nonpharmacologic approaches.

“For children who have regular nightmares that lead to impaired daytime functioning, it may well be a good idea for them to see a sleep physician to discuss whether treatment may be needed,” Dr. Otaiku said.

But should doctors treat children with persistent nightmares for the purpose of preventing neurodegenerative diseases in adulthood or psychiatric problems in adolescence?

“It’s an interesting possibility. However, more research is needed to confirm these epidemiological associations and to determine whether or not nightmares are a causal risk factor for these conditions,” Dr. Otaiku concluded.

The study received no external funding. Dr. Otaiku reports no relevant disclosures.

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

Children who suffer from persistent bad dreams may be at increased risk for cognitive impairment or Parkinson’s disease (PD) later in life, new research shows.

Compared with children who never had distressing dreams between ages 7 and 11 years, those who had persistent distressing dreams were 76% more likely to develop cognitive impairment and roughly seven times more likely to develop PD by age 50 years.

It’s been shown previously that sleep problems in adulthood, including distressing dreams, can precede the onset of neurodegenerative diseases such as Alzheimer’s disease (AD) or PD by several years, and in some cases decades, study investigator Abidemi Otaiku, BMBS, University of Birmingham (England), told this news organization.

However, no studies have investigated whether distressing dreams during childhood might also be associated with increased risk for cognitive decline or PD.

“As such, these findings provide evidence for the first time that certain sleep problems in childhood (having regular distressing dreams) could be an early indicator of increased dementia and PD risk,” Dr. Otaiku said.

He noted that the findings build on previous studies which showed that regular nightmares in childhood could be an early indicator for psychiatric problems in adolescence, such as borderline personality disorder, attention-deficit/hyperactivity disorder, and psychosis.

The study was published online February 26 in The Lancet journal eClinicalMedicine.

Statistically significant

The prospective, longitudinal analysis used data from the 1958 British Birth Cohort Study, a prospective birth cohort which included all people born in Britain during a single week in 1958.

At age 7 years (in 1965) and 11 years (in 1969), mothers were asked to report whether their child experienced “bad dreams or night terrors” in the past 3 months, and cognitive impairment and PD were determined at age 50 (2008).

Among a total of 6,991 children (51% girls), 78.2% never had distressing dreams, 17.9% had transient distressing dreams (either at ages 7 or 11 years), and 3.8% had persistent distressing dreams (at both ages 7 and 11 years).

By age 50, 262 participants had developed cognitive impairment, and five had been diagnosed with PD.

After adjusting for all covariates, having more regular distressing dreams during childhood was “linearly and statistically significantly” associated with higher risk of developing cognitive impairment or PD by age 50 years (P = .037). This was the case in both boys and girls.

Compared with children who never had bad dreams, peers who had persistent distressing dreams (at ages 7 and 11 years) had an 85% increased risk for cognitive impairment or PD by age 50 (adjusted odds ratio, 1.85; 95% confidence interval, 1.10-3.11; P = .019).

The associations remained when incident cognitive impairment and incident PD were analyzed separately.

Compared with children who never had distressing dreams, children who had persistent distressing dreams were 76% more likely to develop cognitive impairment by age 50 years (aOR, 1.76; 95% CI, 1.03-2.99; P = .037), and were about seven times more likely to be diagnosed with PD by age 50 years (aOR, 7.35; 95% CI, 1.03-52.73; P = .047).

The linear association was statistically significant for PD (P = .050) and had a trend toward statistical significance for cognitive impairment (P = .074).

Mechanism unclear

“Early-life nightmares might be causally associated with cognitive impairment and PD, noncausally associated with cognitive impairment and PD, or both. At this stage it remains unclear which of the three options is correct. Therefore, further research on mechanisms is needed,” Dr. Otaiku told this news organization.

“One plausible noncausal explanation is that there are shared genetic factors which predispose individuals to having frequent nightmares in childhood, and to developing neurodegenerative diseases such as AD or PD in adulthood,” he added.

It’s also plausible that having regular nightmares throughout childhood could be a causal risk factor for cognitive impairment and PD by causing chronic sleep disruption, he noted.

“Chronic sleep disruption due to nightmares might lead to impaired glymphatic clearance during sleep – and thus greater accumulation of pathological proteins in the brain, such as amyloid-beta and alpha-synuclein,” Dr. Otaiku said.

Disrupted sleep throughout childhood might also impair normal brain development, which could make children’s brains less resilient to neuropathologic damage, he said.

Clinical implications?

There are established treatments for childhood nightmares, including nonpharmacologic approaches.

“For children who have regular nightmares that lead to impaired daytime functioning, it may well be a good idea for them to see a sleep physician to discuss whether treatment may be needed,” Dr. Otaiku said.

But should doctors treat children with persistent nightmares for the purpose of preventing neurodegenerative diseases in adulthood or psychiatric problems in adolescence?

“It’s an interesting possibility. However, more research is needed to confirm these epidemiological associations and to determine whether or not nightmares are a causal risk factor for these conditions,” Dr. Otaiku concluded.

The study received no external funding. Dr. Otaiku reports no relevant disclosures.

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

If budesonide-formoterol were to become available over the counter (OTC) and used as-needed for mild asthma, it would save lives and cut health care costs, according to a computer modeling study presented at the American Academy of Allergy, Asthma, and Immunology 2023 annual meeting in San Antonio.

Asthma affects 25 million people, about 1 in 13, in the United States. About 28% are uninsured or underinsured, and 70% have mild asthma. Many are using a $30 inhaled epinephrine product (Primatene Mist) – the only FDA-approved asthma inhaler available without a prescription, said Marcus Shaker, MD, MS, professor of pediatrics and medicine at Geisel School of Medicine at Dartmouth, and clinician at Dartmouth Health Children’s, N.H.

A new version of Primatene Mist was reintroduced on the market in 2018 after the product was pulled for containing chlorofluorocarbons in 2011, but it is not recommended by professional medical societies because of safety concerns over epinephrine’s adverse effects, such as increased heart rate and blood pressure.

Drugs in its class (bronchodilators) have long been associated with a higher risk for death or near-death.

Meanwhile, research more than 2 decades ago linked regular use of low-dose inhaled corticosteroids with reduced risk for asthma death.

More recently, two large studies (SYGMA 1 and SYGMA 2) compared maintenance therapy with a low-dose inhaled corticosteroid (budesonide) vs. on-demand treatment with an inhaler containing both a corticosteroid (budesonide) and a long-acting bronchodilator (formoterol).

“Using as-needed budesonide-formoterol led to outcomes that are almost as good as taking a maintenance budesonide dose every day,” said Dr. Shaker.

The Global Initiative for Asthma guidelines now recommend this approach – as-needed inhaled corticosteroids (ICS) plus long-acting bronchodilators – for adults with mild asthma. In the United States, however, the National Heart, Lung, and Blood Institute still suggests daily ICS plus quick-relief therapy as needed.

Dr. Shaker and colleagues used computer modeling to compare the cost-effectiveness of as-needed budesonide-formoterol vs. over-the-counter inhaled epinephrine in underinsured U.S. adults who were self-managing their mild asthma. The study randomly assigned these individuals into three groups: OTC inhaled epinephrine (current reality), OTC budesonide-formoterol (not yet available), or no OTC option. The model assumed that patients treated for an exacerbation were referred to a health care provider and started a regimen of ICS plus as-needed rescue therapy.

In this analysis, which has been submitted for publication, the OTC budesonide-formoterol strategy was associated with 12,495 fewer deaths, prevented nearly 14 million severe asthma exacerbations, and saved more than $68 billion. And “when we looked at OTC budesonide-formoterol vs. having no OTC option at all, budesonide-formoterol was similarly cost-effective,” said Dr. Shaker, who presented the results at an AAAAI oral abstract session.

The cost savings emerged even though in the United States asthma controller therapies (for example, fluticasone) cost about 10 times more than rescue therapies (for instance, salbutamol, OTC epinephrine).

Nevertheless, the results make sense. “If you’re using Primatene Mist, your health costs are predicted to be much greater because you’re going to be in the hospital more. Your asthma is not going to be well-controlled,” Thanai Pongdee, MD, an allergist-immunologist with the Mayo Clinic in Rochester, Minn., told this news organization. “It’s not only the cost of your ER visit but also the cost of loss of work or school, and loss of daily productivity. There are all these associated costs.”

The analysis “is certainly something policy makers could take a look at,” he said.

He noted that current use of budesonide-formoterol is stymied by difficulties with insurance coverage. The difficulties stem from a mismatch between the updated recommendation for as-needed use and the description printed on the brand-name product (Symbicort).

“On the product label, it says Symbicort should be used on a daily basis,” Dr. Pongdee said. “But if a prescription comes through and says you’re going to use this ‘as needed,’ the health plan may say that’s not appropriate because that’s not on the product label.”

Given these access challenges with the all-in-one inhaler, other researchers have developed a workaround – asking patients to continue their usual care (that is, using a rescue inhaler as needed) but to also administer a controller medication after each rescue. When tested in Black and Latino patients with moderate to severe asthma, this easy strategy (patient activated reliever-triggered inhaled corticosteroid, or PARTICS) reduced severe asthma exacerbations about as well as the all-in-one inhaler.

If the all-in-one budesonide-formoterol does become available OTC, Dr. Shaker stressed that it “would not be a substitute for seeing an allergist and getting appropriate medical care and an evaluation and all the rest. But it’s better than the status quo. It’s the sort of thing where the perfect is not the enemy of the good,” he said.

Dr. Shaker is the AAAAI cochair of the Joint Task Force on Practice Parameters and serves as an editorial board member of the Journal of Allergy and Clinical Immunology in Practice. He is also an associate editor of the Annals of Allergy, Asthma, and Immunology. Dr. Pongdee serves as an at-large director on the AAAAI board of directors. He receives grant funding from GlaxoSmithKline, and Mayo Clinic is a trial site for GlaxoSmithKline and AstraZeneca.

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

If budesonide-formoterol were to become available over the counter (OTC) and used as-needed for mild asthma, it would save lives and cut health care costs, according to a computer modeling study presented at the American Academy of Allergy, Asthma, and Immunology 2023 annual meeting in San Antonio.

Asthma affects 25 million people, about 1 in 13, in the United States. About 28% are uninsured or underinsured, and 70% have mild asthma. Many are using a $30 inhaled epinephrine product (Primatene Mist) – the only FDA-approved asthma inhaler available without a prescription, said Marcus Shaker, MD, MS, professor of pediatrics and medicine at Geisel School of Medicine at Dartmouth, and clinician at Dartmouth Health Children’s, N.H.

A new version of Primatene Mist was reintroduced on the market in 2018 after the product was pulled for containing chlorofluorocarbons in 2011, but it is not recommended by professional medical societies because of safety concerns over epinephrine’s adverse effects, such as increased heart rate and blood pressure.

Drugs in its class (bronchodilators) have long been associated with a higher risk for death or near-death.

Meanwhile, research more than 2 decades ago linked regular use of low-dose inhaled corticosteroids with reduced risk for asthma death.

More recently, two large studies (SYGMA 1 and SYGMA 2) compared maintenance therapy with a low-dose inhaled corticosteroid (budesonide) vs. on-demand treatment with an inhaler containing both a corticosteroid (budesonide) and a long-acting bronchodilator (formoterol).

“Using as-needed budesonide-formoterol led to outcomes that are almost as good as taking a maintenance budesonide dose every day,” said Dr. Shaker.

The Global Initiative for Asthma guidelines now recommend this approach – as-needed inhaled corticosteroids (ICS) plus long-acting bronchodilators – for adults with mild asthma. In the United States, however, the National Heart, Lung, and Blood Institute still suggests daily ICS plus quick-relief therapy as needed.

Dr. Shaker and colleagues used computer modeling to compare the cost-effectiveness of as-needed budesonide-formoterol vs. over-the-counter inhaled epinephrine in underinsured U.S. adults who were self-managing their mild asthma. The study randomly assigned these individuals into three groups: OTC inhaled epinephrine (current reality), OTC budesonide-formoterol (not yet available), or no OTC option. The model assumed that patients treated for an exacerbation were referred to a health care provider and started a regimen of ICS plus as-needed rescue therapy.

In this analysis, which has been submitted for publication, the OTC budesonide-formoterol strategy was associated with 12,495 fewer deaths, prevented nearly 14 million severe asthma exacerbations, and saved more than $68 billion. And “when we looked at OTC budesonide-formoterol vs. having no OTC option at all, budesonide-formoterol was similarly cost-effective,” said Dr. Shaker, who presented the results at an AAAAI oral abstract session.

The cost savings emerged even though in the United States asthma controller therapies (for example, fluticasone) cost about 10 times more than rescue therapies (for instance, salbutamol, OTC epinephrine).

Nevertheless, the results make sense. “If you’re using Primatene Mist, your health costs are predicted to be much greater because you’re going to be in the hospital more. Your asthma is not going to be well-controlled,” Thanai Pongdee, MD, an allergist-immunologist with the Mayo Clinic in Rochester, Minn., told this news organization. “It’s not only the cost of your ER visit but also the cost of loss of work or school, and loss of daily productivity. There are all these associated costs.”

The analysis “is certainly something policy makers could take a look at,” he said.

He noted that current use of budesonide-formoterol is stymied by difficulties with insurance coverage. The difficulties stem from a mismatch between the updated recommendation for as-needed use and the description printed on the brand-name product (Symbicort).

“On the product label, it says Symbicort should be used on a daily basis,” Dr. Pongdee said. “But if a prescription comes through and says you’re going to use this ‘as needed,’ the health plan may say that’s not appropriate because that’s not on the product label.”

Given these access challenges with the all-in-one inhaler, other researchers have developed a workaround – asking patients to continue their usual care (that is, using a rescue inhaler as needed) but to also administer a controller medication after each rescue. When tested in Black and Latino patients with moderate to severe asthma, this easy strategy (patient activated reliever-triggered inhaled corticosteroid, or PARTICS) reduced severe asthma exacerbations about as well as the all-in-one inhaler.

If the all-in-one budesonide-formoterol does become available OTC, Dr. Shaker stressed that it “would not be a substitute for seeing an allergist and getting appropriate medical care and an evaluation and all the rest. But it’s better than the status quo. It’s the sort of thing where the perfect is not the enemy of the good,” he said.

Dr. Shaker is the AAAAI cochair of the Joint Task Force on Practice Parameters and serves as an editorial board member of the Journal of Allergy and Clinical Immunology in Practice. He is also an associate editor of the Annals of Allergy, Asthma, and Immunology. Dr. Pongdee serves as an at-large director on the AAAAI board of directors. He receives grant funding from GlaxoSmithKline, and Mayo Clinic is a trial site for GlaxoSmithKline and AstraZeneca.

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

If budesonide-formoterol were to become available over the counter (OTC) and used as-needed for mild asthma, it would save lives and cut health care costs, according to a computer modeling study presented at the American Academy of Allergy, Asthma, and Immunology 2023 annual meeting in San Antonio.

Asthma affects 25 million people, about 1 in 13, in the United States. About 28% are uninsured or underinsured, and 70% have mild asthma. Many are using a $30 inhaled epinephrine product (Primatene Mist) – the only FDA-approved asthma inhaler available without a prescription, said Marcus Shaker, MD, MS, professor of pediatrics and medicine at Geisel School of Medicine at Dartmouth, and clinician at Dartmouth Health Children’s, N.H.

A new version of Primatene Mist was reintroduced on the market in 2018 after the product was pulled for containing chlorofluorocarbons in 2011, but it is not recommended by professional medical societies because of safety concerns over epinephrine’s adverse effects, such as increased heart rate and blood pressure.

Drugs in its class (bronchodilators) have long been associated with a higher risk for death or near-death.

Meanwhile, research more than 2 decades ago linked regular use of low-dose inhaled corticosteroids with reduced risk for asthma death.

More recently, two large studies (SYGMA 1 and SYGMA 2) compared maintenance therapy with a low-dose inhaled corticosteroid (budesonide) vs. on-demand treatment with an inhaler containing both a corticosteroid (budesonide) and a long-acting bronchodilator (formoterol).

“Using as-needed budesonide-formoterol led to outcomes that are almost as good as taking a maintenance budesonide dose every day,” said Dr. Shaker.

The Global Initiative for Asthma guidelines now recommend this approach – as-needed inhaled corticosteroids (ICS) plus long-acting bronchodilators – for adults with mild asthma. In the United States, however, the National Heart, Lung, and Blood Institute still suggests daily ICS plus quick-relief therapy as needed.

Dr. Shaker and colleagues used computer modeling to compare the cost-effectiveness of as-needed budesonide-formoterol vs. over-the-counter inhaled epinephrine in underinsured U.S. adults who were self-managing their mild asthma. The study randomly assigned these individuals into three groups: OTC inhaled epinephrine (current reality), OTC budesonide-formoterol (not yet available), or no OTC option. The model assumed that patients treated for an exacerbation were referred to a health care provider and started a regimen of ICS plus as-needed rescue therapy.

In this analysis, which has been submitted for publication, the OTC budesonide-formoterol strategy was associated with 12,495 fewer deaths, prevented nearly 14 million severe asthma exacerbations, and saved more than $68 billion. And “when we looked at OTC budesonide-formoterol vs. having no OTC option at all, budesonide-formoterol was similarly cost-effective,” said Dr. Shaker, who presented the results at an AAAAI oral abstract session.

The cost savings emerged even though in the United States asthma controller therapies (for example, fluticasone) cost about 10 times more than rescue therapies (for instance, salbutamol, OTC epinephrine).

Nevertheless, the results make sense. “If you’re using Primatene Mist, your health costs are predicted to be much greater because you’re going to be in the hospital more. Your asthma is not going to be well-controlled,” Thanai Pongdee, MD, an allergist-immunologist with the Mayo Clinic in Rochester, Minn., told this news organization. “It’s not only the cost of your ER visit but also the cost of loss of work or school, and loss of daily productivity. There are all these associated costs.”

The analysis “is certainly something policy makers could take a look at,” he said.

He noted that current use of budesonide-formoterol is stymied by difficulties with insurance coverage. The difficulties stem from a mismatch between the updated recommendation for as-needed use and the description printed on the brand-name product (Symbicort).

“On the product label, it says Symbicort should be used on a daily basis,” Dr. Pongdee said. “But if a prescription comes through and says you’re going to use this ‘as needed,’ the health plan may say that’s not appropriate because that’s not on the product label.”

Given these access challenges with the all-in-one inhaler, other researchers have developed a workaround – asking patients to continue their usual care (that is, using a rescue inhaler as needed) but to also administer a controller medication after each rescue. When tested in Black and Latino patients with moderate to severe asthma, this easy strategy (patient activated reliever-triggered inhaled corticosteroid, or PARTICS) reduced severe asthma exacerbations about as well as the all-in-one inhaler.

If the all-in-one budesonide-formoterol does become available OTC, Dr. Shaker stressed that it “would not be a substitute for seeing an allergist and getting appropriate medical care and an evaluation and all the rest. But it’s better than the status quo. It’s the sort of thing where the perfect is not the enemy of the good,” he said.

Dr. Shaker is the AAAAI cochair of the Joint Task Force on Practice Parameters and serves as an editorial board member of the Journal of Allergy and Clinical Immunology in Practice. He is also an associate editor of the Annals of Allergy, Asthma, and Immunology. Dr. Pongdee serves as an at-large director on the AAAAI board of directors. He receives grant funding from GlaxoSmithKline, and Mayo Clinic is a trial site for GlaxoSmithKline and AstraZeneca.

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

HONOLULU – With so many kids missing childhood vaccinations during the acute phase of the COVID-19 pandemic, think measles in patients who present with high fever, cough, and a maculopapular eruption.

“Measles is one of the most contagious of human viruses, and we are seeing a resurgence,” Adelaide A. Hebert, MD, professor of dermatology and pediatrics, and chief of pediatric dermatology at the Universtiy of Texas, Houston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “This is a re-emerging viral infection that dermatologists must recognize. Measles often starts behind the ears, and the eruption can look a lot like a drug eruption,” she noted. “Many of my pediatric colleagues have never seen a case of measles before because we have had a vaccine since 1963. Measles can almost entirely be prevented with vaccination. You get herd immunity if both doses have been administered to 95% of the population.”

In 2021, the World Health Organization estimated that 25 million children worldwide missed the measles vaccine. This caused 9 million cases of measles and 128,000 deaths in 22 countries, mainly from viral pneumonia, secondary bacterial pneumonia, and postviral encephalitis. According to the Centers for Disease Control and Prevention, 1,274 measles cases occurred in 31 states in 2019, mostly in individuals who were not vaccinated against it. Reported cases fell to 13 in 2020 but rose to 49 cases in 2021 and to 121 cases in 2022. As of Feb. 28, 2023, three cases have been reported in the United States.

“Measles spreads through direct contact with an infected person and through airborne transmission,” said Dr. Hebert, who recommended an article published in The Lancet for background on the topic. “Unlike COVID-19, measles has not mutated, so the original measles vaccine will work very well.”

Common clinical signs of measles include a generalized, maculopapular eruption lasting for 3 days or more, a temperature above 101° F plus cough, coryza, or conjunctivitis. Confirmation of measles can be made by PCR for viral RNA. Clinicians can also send a blood draw to the state public health lab for analysis. The serologic standard is a fourfold rise or fall in IgG titer with a paired sample sent 10-14 days after the initial collection.

“You can administer immune globulin up to 6 days after exposure to potentially prevent measles or decrease severity [in] immunocompromised hosts not previously vaccinated,” she said. The recommended intramuscular dose is 0.5 mL/kg, up to a dose of 15 mL/kg. Treatment is supportive and focused on relieving common symptoms and providing nutritional support. Administration of vitamin A is currently recommended for all children with acute measles.

Vitamin A supplements are available either as capsules (50,000 IU; 100,000 IU; 200,000 IU) or in liquid form. Parenteral formulations are also available. “Capsules need to be cut open and the contents squeezed into the mouths of children younger than 2 years,” Dr. Hebert said. “Capsules have the advantage that they can be given to mothers for administration at home.”

The recommended dosage of vitamin A in children is as follows, she said:

• Aged 12 months or older: 200,000 IU daily for 2 days.
• Aged 6 to 11 months: 100,000 IU daily for 2 days.
• Aged 6 months or younger: 50,000 IU daily for 2 days.

The American Academy of Pediatrics recommends a third dose given 2-4 weeks later to children with clinical signs and symptoms of vitamin A deficiency.

In an interview following the meeting, Moise L. Levy, MD, professor of internal medicine and pediatrics at the University of Texas, Austin, emphasized that when clinicians evaluate pediatric patients with viral symptoms such as fever, cough, and skin eruption, “measles should be in the differential diagnosis.” The 2022 uptick in measles cases “would be another reason to engage in regular vaccinations.”

Dr. Hebert disclosed that she is a consultant or advisor for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica.

Dr. Levy disclosed that he is consultant or advisor for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi-Genzyme.

MedscapeLIVE! and this news organization are owned by the same parent company.

HONOLULU – With so many kids missing childhood vaccinations during the acute phase of the COVID-19 pandemic, think measles in patients who present with high fever, cough, and a maculopapular eruption.

“Measles is one of the most contagious of human viruses, and we are seeing a resurgence,” Adelaide A. Hebert, MD, professor of dermatology and pediatrics, and chief of pediatric dermatology at the Universtiy of Texas, Houston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “This is a re-emerging viral infection that dermatologists must recognize. Measles often starts behind the ears, and the eruption can look a lot like a drug eruption,” she noted. “Many of my pediatric colleagues have never seen a case of measles before because we have had a vaccine since 1963. Measles can almost entirely be prevented with vaccination. You get herd immunity if both doses have been administered to 95% of the population.”

In 2021, the World Health Organization estimated that 25 million children worldwide missed the measles vaccine. This caused 9 million cases of measles and 128,000 deaths in 22 countries, mainly from viral pneumonia, secondary bacterial pneumonia, and postviral encephalitis. According to the Centers for Disease Control and Prevention, 1,274 measles cases occurred in 31 states in 2019, mostly in individuals who were not vaccinated against it. Reported cases fell to 13 in 2020 but rose to 49 cases in 2021 and to 121 cases in 2022. As of Feb. 28, 2023, three cases have been reported in the United States.

“Measles spreads through direct contact with an infected person and through airborne transmission,” said Dr. Hebert, who recommended an article published in The Lancet for background on the topic. “Unlike COVID-19, measles has not mutated, so the original measles vaccine will work very well.”

Common clinical signs of measles include a generalized, maculopapular eruption lasting for 3 days or more, a temperature above 101° F plus cough, coryza, or conjunctivitis. Confirmation of measles can be made by PCR for viral RNA. Clinicians can also send a blood draw to the state public health lab for analysis. The serologic standard is a fourfold rise or fall in IgG titer with a paired sample sent 10-14 days after the initial collection.

“You can administer immune globulin up to 6 days after exposure to potentially prevent measles or decrease severity [in] immunocompromised hosts not previously vaccinated,” she said. The recommended intramuscular dose is 0.5 mL/kg, up to a dose of 15 mL/kg. Treatment is supportive and focused on relieving common symptoms and providing nutritional support. Administration of vitamin A is currently recommended for all children with acute measles.

Vitamin A supplements are available either as capsules (50,000 IU; 100,000 IU; 200,000 IU) or in liquid form. Parenteral formulations are also available. “Capsules need to be cut open and the contents squeezed into the mouths of children younger than 2 years,” Dr. Hebert said. “Capsules have the advantage that they can be given to mothers for administration at home.”

The recommended dosage of vitamin A in children is as follows, she said:

• Aged 12 months or older: 200,000 IU daily for 2 days.
• Aged 6 to 11 months: 100,000 IU daily for 2 days.
• Aged 6 months or younger: 50,000 IU daily for 2 days.

The American Academy of Pediatrics recommends a third dose given 2-4 weeks later to children with clinical signs and symptoms of vitamin A deficiency.

In an interview following the meeting, Moise L. Levy, MD, professor of internal medicine and pediatrics at the University of Texas, Austin, emphasized that when clinicians evaluate pediatric patients with viral symptoms such as fever, cough, and skin eruption, “measles should be in the differential diagnosis.” The 2022 uptick in measles cases “would be another reason to engage in regular vaccinations.”

Dr. Hebert disclosed that she is a consultant or advisor for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica.

Dr. Levy disclosed that he is consultant or advisor for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi-Genzyme.

MedscapeLIVE! and this news organization are owned by the same parent company.

HONOLULU – With so many kids missing childhood vaccinations during the acute phase of the COVID-19 pandemic, think measles in patients who present with high fever, cough, and a maculopapular eruption.

“Measles is one of the most contagious of human viruses, and we are seeing a resurgence,” Adelaide A. Hebert, MD, professor of dermatology and pediatrics, and chief of pediatric dermatology at the Universtiy of Texas, Houston, said at the Hawaii Dermatology Seminar provided by MedscapeLIVE! “This is a re-emerging viral infection that dermatologists must recognize. Measles often starts behind the ears, and the eruption can look a lot like a drug eruption,” she noted. “Many of my pediatric colleagues have never seen a case of measles before because we have had a vaccine since 1963. Measles can almost entirely be prevented with vaccination. You get herd immunity if both doses have been administered to 95% of the population.”

In 2021, the World Health Organization estimated that 25 million children worldwide missed the measles vaccine. This caused 9 million cases of measles and 128,000 deaths in 22 countries, mainly from viral pneumonia, secondary bacterial pneumonia, and postviral encephalitis. According to the Centers for Disease Control and Prevention, 1,274 measles cases occurred in 31 states in 2019, mostly in individuals who were not vaccinated against it. Reported cases fell to 13 in 2020 but rose to 49 cases in 2021 and to 121 cases in 2022. As of Feb. 28, 2023, three cases have been reported in the United States.

“Measles spreads through direct contact with an infected person and through airborne transmission,” said Dr. Hebert, who recommended an article published in The Lancet for background on the topic. “Unlike COVID-19, measles has not mutated, so the original measles vaccine will work very well.”

Common clinical signs of measles include a generalized, maculopapular eruption lasting for 3 days or more, a temperature above 101° F plus cough, coryza, or conjunctivitis. Confirmation of measles can be made by PCR for viral RNA. Clinicians can also send a blood draw to the state public health lab for analysis. The serologic standard is a fourfold rise or fall in IgG titer with a paired sample sent 10-14 days after the initial collection.

“You can administer immune globulin up to 6 days after exposure to potentially prevent measles or decrease severity [in] immunocompromised hosts not previously vaccinated,” she said. The recommended intramuscular dose is 0.5 mL/kg, up to a dose of 15 mL/kg. Treatment is supportive and focused on relieving common symptoms and providing nutritional support. Administration of vitamin A is currently recommended for all children with acute measles.

Vitamin A supplements are available either as capsules (50,000 IU; 100,000 IU; 200,000 IU) or in liquid form. Parenteral formulations are also available. “Capsules need to be cut open and the contents squeezed into the mouths of children younger than 2 years,” Dr. Hebert said. “Capsules have the advantage that they can be given to mothers for administration at home.”

The recommended dosage of vitamin A in children is as follows, she said:

• Aged 12 months or older: 200,000 IU daily for 2 days.
• Aged 6 to 11 months: 100,000 IU daily for 2 days.
• Aged 6 months or younger: 50,000 IU daily for 2 days.

The American Academy of Pediatrics recommends a third dose given 2-4 weeks later to children with clinical signs and symptoms of vitamin A deficiency.

In an interview following the meeting, Moise L. Levy, MD, professor of internal medicine and pediatrics at the University of Texas, Austin, emphasized that when clinicians evaluate pediatric patients with viral symptoms such as fever, cough, and skin eruption, “measles should be in the differential diagnosis.” The 2022 uptick in measles cases “would be another reason to engage in regular vaccinations.”

Dr. Hebert disclosed that she is a consultant or advisor for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica.

Dr. Levy disclosed that he is consultant or advisor for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi-Genzyme.

MedscapeLIVE! and this news organization are owned by the same parent company.

Despite the profound shift in guidelines for preventing peanut allergies in infants after the landmark LEAP study, national surveys in 2021 showed that 70% of parents and caregivers said that they hadn’t heard the new recommendations, and fewer than one-third of pediatricians were following them.

Now, in a 5-year National Institutes of Health–funded study called iREACH, researchers are testing whether a two-part intervention, which includes training videos and a clinical decision support tool, helps pediatricians follow the guidelines and ultimately reduces peanut allergy.

Early results from iREACH, presented at the American Academy of Allergy, Asthma, and Immunology 2023 annual meeting in San Antonio, showed mixed results with a sharp rise in clinician knowledge of the guidelines but only a modest increase in their real-world implementation with high-risk infants.

Raising a food-allergic child while working as a pediatrician herself, Ruchi Gupta, MD, MPH, director of the Center for Food Allergy and Asthma Research at Northwestern University, Chicago, understands the importance and challenge of translating published findings into practice.

During a typical 4- to 6-month well-child visit, pediatricians must check the baby’s growth, perform a physical exam, discuss milestones, field questions about sleep and poop and colic and – if they’re up on the latest guidelines – explain why it’s important to feed peanuts early and often.

“Pediatricians get stuff from every single specialty, and guidelines are always changing,” she told this news organization.

The current feeding guidelines, published in 2017 after the landmark LEAP study, switched from “ ‘don’t introduce peanuts until age 3’ to ‘introduce peanuts now,’ ” said Dr. Gupta.

But the recommendations aren’t entirely straightforward. They require pediatricians to make an assessment when the baby is around 4 months old. If the child is high-risk (has severe eczema or an egg allergy), they need a peanut-specific immunoglobulin E (IgE) test. If the test is negative, the pediatrician should encourage peanut introduction. If positive, they should refer the child to an allergist.

“It’s a little complicated,” Dr. Gupta said.

To boost understanding and adherence, Dr. Gupta’s team created the intervention tested in the iREACH study. It includes a set of training videos, a clinical decision support tool that embeds into the electronic health record (EHR) with pop-ups reminding the physician to discuss early introduction, menus for ordering peanut IgE tests or referring to an allergist if needed, and a caregiver handout that explains how to add peanuts to the baby’s diet. (These resources can be found here.)

The study enrolled 290 pediatric clinicians at 30 local practices, examining 18,460 babies from diverse backgrounds, about one-quarter of whom were from families on public insurance. About half of the clinicians received the intervention, whereas the other half served as the control arm.

The training videos seemed effective. Clinicians’ knowledge of the guidelines rose from 72.6% at baseline to 94.5% after the intervention, and their ability to identify severe eczema went up from 63.4% to 97.6%. This translated to 70.4% success with applying the guidelines when presented various clinical scenarios, up from 29% at baseline. These results are in press at JAMA Network Open.

The next set of analyses, preliminary and unpublished, monitored real-world adherence using natural language processing to pull EHR data from 4- and 6-month well-check visits. It was “AI [artificial intelligence] for notes,” Dr. Gupta said.

For low-risk infants, the training and EHR-embedded support tool greatly improved clinician adherence. Eighty percent of clinicians in the intervention arm followed the guidelines, compared with 26% in the control group.

In high-risk infants, the impact was much weaker. Even after the video-based training, only 17% of pediatric clinicians followed the guidelines – that is, ordered a peanut IgE test or referred to an allergist – compared with 8% in the control group.

Why such a low uptake?

Pediatricians are time-pressed. “How do you add [early introduction] to the other 10 or 15 things you want to talk to a parent about at the 4-month visit?” said Jonathan Necheles, MD, MPH, a pediatrician at Children’s Healthcare Associates in Chicago.

It can also be hard to tell if a baby’s eczema is “severe” or “mild to moderate.” The EHR-integrated support tool included a scorecard for judging eczema severity across a range of skin tones. The condition can be hard to recognize in patients of color. “You don’t get the redness in the same way,” said Dr. Necheles, who worked with Dr. Gupta to develop the iREACH intervention.

Curiously, even though the AI analysis found that less than one-fifth of pediatricians put the guidelines into action for high-risk infants, 69% of them recommended peanut introduction.

One interpretation is that busy pediatricians may be “doing the minimum” – introducing the concept of early introduction and telling parents to try it “but not giving any additional sort of guidance as far as who’s high risk, who’s low risk, who should see the allergist, who should get screened,” said Edwin Kim, MD, allergist-immunologist and director of the Food Allergy Initiative at the University of North Carolina at Chapel Hill.

The ultimate impact of iREACH has yet to be seen. “The end goal is, if pediatricians recommend, will parents follow, and will we reduce peanut allergy?” Dr. Gupta said.

Dr. Gupta consults or serves as an advisor for Genentech, Novartis, Aimmune, Allergenis, and Food Allergy Research & Education; receives research funding from Novartis, Genentech, FARE, Melchiorre Family Foundation, and Sunshine Charitable Foundation; and reports ownership interest from Yobee Care. Dr. Necheles reports no financial disclosures. Dr. Kim reports consultancy with Allergy Therapeutics, Belhaven Biopharma, Duke Clinical Research Institute, Genentech, Nutricia, and Revolo; advisory board membership with ALK, Kenota Health, and Ukko; and grant support from the National Institute of Allergy and Infectious Diseases, Immune Tolerance Network, and Food Allergy Research and Education.

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

Despite the profound shift in guidelines for preventing peanut allergies in infants after the landmark LEAP study, national surveys in 2021 showed that 70% of parents and caregivers said that they hadn’t heard the new recommendations, and fewer than one-third of pediatricians were following them.

Now, in a 5-year National Institutes of Health–funded study called iREACH, researchers are testing whether a two-part intervention, which includes training videos and a clinical decision support tool, helps pediatricians follow the guidelines and ultimately reduces peanut allergy.

Early results from iREACH, presented at the American Academy of Allergy, Asthma, and Immunology 2023 annual meeting in San Antonio, showed mixed results with a sharp rise in clinician knowledge of the guidelines but only a modest increase in their real-world implementation with high-risk infants.

Raising a food-allergic child while working as a pediatrician herself, Ruchi Gupta, MD, MPH, director of the Center for Food Allergy and Asthma Research at Northwestern University, Chicago, understands the importance and challenge of translating published findings into practice.

During a typical 4- to 6-month well-child visit, pediatricians must check the baby’s growth, perform a physical exam, discuss milestones, field questions about sleep and poop and colic and – if they’re up on the latest guidelines – explain why it’s important to feed peanuts early and often.

“Pediatricians get stuff from every single specialty, and guidelines are always changing,” she told this news organization.

The current feeding guidelines, published in 2017 after the landmark LEAP study, switched from “ ‘don’t introduce peanuts until age 3’ to ‘introduce peanuts now,’ ” said Dr. Gupta.

But the recommendations aren’t entirely straightforward. They require pediatricians to make an assessment when the baby is around 4 months old. If the child is high-risk (has severe eczema or an egg allergy), they need a peanut-specific immunoglobulin E (IgE) test. If the test is negative, the pediatrician should encourage peanut introduction. If positive, they should refer the child to an allergist.

“It’s a little complicated,” Dr. Gupta said.

To boost understanding and adherence, Dr. Gupta’s team created the intervention tested in the iREACH study. It includes a set of training videos, a clinical decision support tool that embeds into the electronic health record (EHR) with pop-ups reminding the physician to discuss early introduction, menus for ordering peanut IgE tests or referring to an allergist if needed, and a caregiver handout that explains how to add peanuts to the baby’s diet. (These resources can be found here.)

The study enrolled 290 pediatric clinicians at 30 local practices, examining 18,460 babies from diverse backgrounds, about one-quarter of whom were from families on public insurance. About half of the clinicians received the intervention, whereas the other half served as the control arm.

The training videos seemed effective. Clinicians’ knowledge of the guidelines rose from 72.6% at baseline to 94.5% after the intervention, and their ability to identify severe eczema went up from 63.4% to 97.6%. This translated to 70.4% success with applying the guidelines when presented various clinical scenarios, up from 29% at baseline. These results are in press at JAMA Network Open.

The next set of analyses, preliminary and unpublished, monitored real-world adherence using natural language processing to pull EHR data from 4- and 6-month well-check visits. It was “AI [artificial intelligence] for notes,” Dr. Gupta said.

For low-risk infants, the training and EHR-embedded support tool greatly improved clinician adherence. Eighty percent of clinicians in the intervention arm followed the guidelines, compared with 26% in the control group.

In high-risk infants, the impact was much weaker. Even after the video-based training, only 17% of pediatric clinicians followed the guidelines – that is, ordered a peanut IgE test or referred to an allergist – compared with 8% in the control group.

Why such a low uptake?

Pediatricians are time-pressed. “How do you add [early introduction] to the other 10 or 15 things you want to talk to a parent about at the 4-month visit?” said Jonathan Necheles, MD, MPH, a pediatrician at Children’s Healthcare Associates in Chicago.

It can also be hard to tell if a baby’s eczema is “severe” or “mild to moderate.” The EHR-integrated support tool included a scorecard for judging eczema severity across a range of skin tones. The condition can be hard to recognize in patients of color. “You don’t get the redness in the same way,” said Dr. Necheles, who worked with Dr. Gupta to develop the iREACH intervention.

Curiously, even though the AI analysis found that less than one-fifth of pediatricians put the guidelines into action for high-risk infants, 69% of them recommended peanut introduction.

One interpretation is that busy pediatricians may be “doing the minimum” – introducing the concept of early introduction and telling parents to try it “but not giving any additional sort of guidance as far as who’s high risk, who’s low risk, who should see the allergist, who should get screened,” said Edwin Kim, MD, allergist-immunologist and director of the Food Allergy Initiative at the University of North Carolina at Chapel Hill.

The ultimate impact of iREACH has yet to be seen. “The end goal is, if pediatricians recommend, will parents follow, and will we reduce peanut allergy?” Dr. Gupta said.

Dr. Gupta consults or serves as an advisor for Genentech, Novartis, Aimmune, Allergenis, and Food Allergy Research & Education; receives research funding from Novartis, Genentech, FARE, Melchiorre Family Foundation, and Sunshine Charitable Foundation; and reports ownership interest from Yobee Care. Dr. Necheles reports no financial disclosures. Dr. Kim reports consultancy with Allergy Therapeutics, Belhaven Biopharma, Duke Clinical Research Institute, Genentech, Nutricia, and Revolo; advisory board membership with ALK, Kenota Health, and Ukko; and grant support from the National Institute of Allergy and Infectious Diseases, Immune Tolerance Network, and Food Allergy Research and Education.

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

Despite the profound shift in guidelines for preventing peanut allergies in infants after the landmark LEAP study, national surveys in 2021 showed that 70% of parents and caregivers said that they hadn’t heard the new recommendations, and fewer than one-third of pediatricians were following them.

Now, in a 5-year National Institutes of Health–funded study called iREACH, researchers are testing whether a two-part intervention, which includes training videos and a clinical decision support tool, helps pediatricians follow the guidelines and ultimately reduces peanut allergy.

Early results from iREACH, presented at the American Academy of Allergy, Asthma, and Immunology 2023 annual meeting in San Antonio, showed mixed results with a sharp rise in clinician knowledge of the guidelines but only a modest increase in their real-world implementation with high-risk infants.

Raising a food-allergic child while working as a pediatrician herself, Ruchi Gupta, MD, MPH, director of the Center for Food Allergy and Asthma Research at Northwestern University, Chicago, understands the importance and challenge of translating published findings into practice.

During a typical 4- to 6-month well-child visit, pediatricians must check the baby’s growth, perform a physical exam, discuss milestones, field questions about sleep and poop and colic and – if they’re up on the latest guidelines – explain why it’s important to feed peanuts early and often.

“Pediatricians get stuff from every single specialty, and guidelines are always changing,” she told this news organization.

The current feeding guidelines, published in 2017 after the landmark LEAP study, switched from “ ‘don’t introduce peanuts until age 3’ to ‘introduce peanuts now,’ ” said Dr. Gupta.

But the recommendations aren’t entirely straightforward. They require pediatricians to make an assessment when the baby is around 4 months old. If the child is high-risk (has severe eczema or an egg allergy), they need a peanut-specific immunoglobulin E (IgE) test. If the test is negative, the pediatrician should encourage peanut introduction. If positive, they should refer the child to an allergist.

“It’s a little complicated,” Dr. Gupta said.

To boost understanding and adherence, Dr. Gupta’s team created the intervention tested in the iREACH study. It includes a set of training videos, a clinical decision support tool that embeds into the electronic health record (EHR) with pop-ups reminding the physician to discuss early introduction, menus for ordering peanut IgE tests or referring to an allergist if needed, and a caregiver handout that explains how to add peanuts to the baby’s diet. (These resources can be found here.)

The study enrolled 290 pediatric clinicians at 30 local practices, examining 18,460 babies from diverse backgrounds, about one-quarter of whom were from families on public insurance. About half of the clinicians received the intervention, whereas the other half served as the control arm.

The training videos seemed effective. Clinicians’ knowledge of the guidelines rose from 72.6% at baseline to 94.5% after the intervention, and their ability to identify severe eczema went up from 63.4% to 97.6%. This translated to 70.4% success with applying the guidelines when presented various clinical scenarios, up from 29% at baseline. These results are in press at JAMA Network Open.

The next set of analyses, preliminary and unpublished, monitored real-world adherence using natural language processing to pull EHR data from 4- and 6-month well-check visits. It was “AI [artificial intelligence] for notes,” Dr. Gupta said.

For low-risk infants, the training and EHR-embedded support tool greatly improved clinician adherence. Eighty percent of clinicians in the intervention arm followed the guidelines, compared with 26% in the control group.

In high-risk infants, the impact was much weaker. Even after the video-based training, only 17% of pediatric clinicians followed the guidelines – that is, ordered a peanut IgE test or referred to an allergist – compared with 8% in the control group.

Why such a low uptake?

Pediatricians are time-pressed. “How do you add [early introduction] to the other 10 or 15 things you want to talk to a parent about at the 4-month visit?” said Jonathan Necheles, MD, MPH, a pediatrician at Children’s Healthcare Associates in Chicago.

It can also be hard to tell if a baby’s eczema is “severe” or “mild to moderate.” The EHR-integrated support tool included a scorecard for judging eczema severity across a range of skin tones. The condition can be hard to recognize in patients of color. “You don’t get the redness in the same way,” said Dr. Necheles, who worked with Dr. Gupta to develop the iREACH intervention.

Curiously, even though the AI analysis found that less than one-fifth of pediatricians put the guidelines into action for high-risk infants, 69% of them recommended peanut introduction.

One interpretation is that busy pediatricians may be “doing the minimum” – introducing the concept of early introduction and telling parents to try it “but not giving any additional sort of guidance as far as who’s high risk, who’s low risk, who should see the allergist, who should get screened,” said Edwin Kim, MD, allergist-immunologist and director of the Food Allergy Initiative at the University of North Carolina at Chapel Hill.

The ultimate impact of iREACH has yet to be seen. “The end goal is, if pediatricians recommend, will parents follow, and will we reduce peanut allergy?” Dr. Gupta said.

Dr. Gupta consults or serves as an advisor for Genentech, Novartis, Aimmune, Allergenis, and Food Allergy Research & Education; receives research funding from Novartis, Genentech, FARE, Melchiorre Family Foundation, and Sunshine Charitable Foundation; and reports ownership interest from Yobee Care. Dr. Necheles reports no financial disclosures. Dr. Kim reports consultancy with Allergy Therapeutics, Belhaven Biopharma, Duke Clinical Research Institute, Genentech, Nutricia, and Revolo; advisory board membership with ALK, Kenota Health, and Ukko; and grant support from the National Institute of Allergy and Infectious Diseases, Immune Tolerance Network, and Food Allergy Research and Education.

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

A combination of gradual aerobic exercise and breathing practice can help ease persistent postconcussive symptoms, preliminary findings from a new study suggest.

Heart rate variability biofeedback (HRVB) and progressive aerobic exercise (PAE) were each helpful on their own, but combining them led to even greater improvement in cognition, depression, and mood.

“Managing persistent concussion symptoms is particularly challenging as there are no standard therapies,” study investigator R. Davis Moore, PhD, from the University of South Carolina, Columbia, said in a news release.

“These therapies are inexpensive, easy to implement, and can be self-administered, making them feasible and accessible for everyone with persistent symptoms,” Dr. Moore noted.

The study was released early, ahead of its scheduled presentation in Boston at the annual meeting of the American Academy of Neurology.
 

Targeting autonomic dysfunction

Concussion can affect the autonomic nervous system, and it is “increasingly clear that this underlies the inability to tolerate exercise, problems with thinking skills, and mood issues in those with persisting symptoms,” Dr. Moore explained.

Preliminary research suggests that HRVB and PAE can improve cardio-autonomic dysfunction and clinical symptoms. However, until now, no study has evaluated whether there is additional benefit from combining the two.

The investigators randomly assigned 30 teens with postconcussive symptoms that had lasted more than 1 month to a 6-week intervention consisting of either HRVB, PAE, or HRVB plus PAE.

The HRVB group practiced resonant-frequency breathing using a handheld biofeedback device for 20 minutes 4 nights a week. The PAE group completed a 3-day-a-week aerobic exercise protocol that gradually increased in intensity and duration. The HRVB plus PAE group did both. Concussion symptoms, HRV, cognition, and mood were assessed at baseline and again 6 weeks later.

All participants experienced improvement in sleep, mood, cognition, and autonomic function, but those who received the combined biofeedback and exercise intervention experienced greater improvements than peers who engaged in exercise or received biofeedback alone.

The study’s top-line results, which were released ahead of the presentation, show that HRVB plus PAE is associated with a twofold greater reduction in symptom severity, compared with PAE only, and a 1.3 times greater reduction in symptom severity, compared with HRVB only.

Similarly, HRVB plus PAE led to a 1.2 times greater reduction in symptoms of depression, compared with PAE only, and a 1.3 times greater reduction, compared with HRVB only.

The combined group also experienced more than 1.4 times the reduction in total mood disturbance than was provided by exercise or biofeedback alone.

The combined group also experienced significantly greater improvements in attention and working memory, as well as greater changes in metrics of HRV, than the groups that participated in exercise or biofeedback alone.

Dr. Moore and colleagues caution that the current results are preliminary and that future studies are needed with larger groups of people.

A limitation of the study was that it did not include a control group of people with persistent postconcussive symptoms who received no intervention.
 

Complex problem

Commenting on the findings, neuroscientist José Posas, MD, director of the Ochsner Neurology Residency Program, New Orleans, who wasn’t involved in the study, said these preliminary results are “promising” but cited the small number of participants as a limitation.

Dr. Posas said the results “fit with what’s known about the role of postconcussion autonomic dysfunction in persisting postconcussive symptoms.

“Managing persistent concussion symptoms can be challenging,” he added, and this study supports “exercise as medicine” as well as taking a “mind-body, holistic approach” to postconcussion recovery, said Dr. Posas.

Also weighing in, Michael F. Bergeron, PhD, clinical and scientific advisor, Department of Performance Health, Women’s Tennis Association, noted that “each of these therapeutic interventions has been around for some time now. Neither is new.

“Heart rate variability biofeedback based on variation in heart rate corresponding to breathing has been shown to be effective in treating numerous conditions, including reducing (nonclinical) stress, anxiety, depression, anger, and posttraumatic stress disorder in veterans and in some instances enhancing athletic performance. Of course, the validity and reliability of the commercially available apps and devices are potential significant limitations, as well as the stability of the user’s technique,” Dr. Bergeron said.

“It’s also been recognized that low-level aerobic exercise treatment normalizes the cerebrovascular physiological dysfunction in patients with concussion by increasing CO₂ sensitivity, which normalizes exercise ventilation and cerebral blood flow and thus reduces some symptoms,” Dr. Bergeron added.

“The combination of treatments is likely the novel aspect, which makes sense because brain injury is complex, and effective interventions need to utilize a complex, integrated biological systems approach across the multiple interdependent domains of influence,” Dr. Bergeron said.

The study was supported by the nonprofit Woodcock Institute at Texas Woman’s University. Dr. Moore, Dr. Bergeron, and Dr. Posas have disclosed no relevant financial relationships.

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

A combination of gradual aerobic exercise and breathing practice can help ease persistent postconcussive symptoms, preliminary findings from a new study suggest.

Heart rate variability biofeedback (HRVB) and progressive aerobic exercise (PAE) were each helpful on their own, but combining them led to even greater improvement in cognition, depression, and mood.

“Managing persistent concussion symptoms is particularly challenging as there are no standard therapies,” study investigator R. Davis Moore, PhD, from the University of South Carolina, Columbia, said in a news release.

“These therapies are inexpensive, easy to implement, and can be self-administered, making them feasible and accessible for everyone with persistent symptoms,” Dr. Moore noted.

The study was released early, ahead of its scheduled presentation in Boston at the annual meeting of the American Academy of Neurology.
 

Targeting autonomic dysfunction

Concussion can affect the autonomic nervous system, and it is “increasingly clear that this underlies the inability to tolerate exercise, problems with thinking skills, and mood issues in those with persisting symptoms,” Dr. Moore explained.

Preliminary research suggests that HRVB and PAE can improve cardio-autonomic dysfunction and clinical symptoms. However, until now, no study has evaluated whether there is additional benefit from combining the two.

The investigators randomly assigned 30 teens with postconcussive symptoms that had lasted more than 1 month to a 6-week intervention consisting of either HRVB, PAE, or HRVB plus PAE.

The HRVB group practiced resonant-frequency breathing using a handheld biofeedback device for 20 minutes 4 nights a week. The PAE group completed a 3-day-a-week aerobic exercise protocol that gradually increased in intensity and duration. The HRVB plus PAE group did both. Concussion symptoms, HRV, cognition, and mood were assessed at baseline and again 6 weeks later.

All participants experienced improvement in sleep, mood, cognition, and autonomic function, but those who received the combined biofeedback and exercise intervention experienced greater improvements than peers who engaged in exercise or received biofeedback alone.

The study’s top-line results, which were released ahead of the presentation, show that HRVB plus PAE is associated with a twofold greater reduction in symptom severity, compared with PAE only, and a 1.3 times greater reduction in symptom severity, compared with HRVB only.

Similarly, HRVB plus PAE led to a 1.2 times greater reduction in symptoms of depression, compared with PAE only, and a 1.3 times greater reduction, compared with HRVB only.

The combined group also experienced more than 1.4 times the reduction in total mood disturbance than was provided by exercise or biofeedback alone.

The combined group also experienced significantly greater improvements in attention and working memory, as well as greater changes in metrics of HRV, than the groups that participated in exercise or biofeedback alone.

Dr. Moore and colleagues caution that the current results are preliminary and that future studies are needed with larger groups of people.

A limitation of the study was that it did not include a control group of people with persistent postconcussive symptoms who received no intervention.
 

Complex problem

Commenting on the findings, neuroscientist José Posas, MD, director of the Ochsner Neurology Residency Program, New Orleans, who wasn’t involved in the study, said these preliminary results are “promising” but cited the small number of participants as a limitation.

Dr. Posas said the results “fit with what’s known about the role of postconcussion autonomic dysfunction in persisting postconcussive symptoms.

“Managing persistent concussion symptoms can be challenging,” he added, and this study supports “exercise as medicine” as well as taking a “mind-body, holistic approach” to postconcussion recovery, said Dr. Posas.

Also weighing in, Michael F. Bergeron, PhD, clinical and scientific advisor, Department of Performance Health, Women’s Tennis Association, noted that “each of these therapeutic interventions has been around for some time now. Neither is new.

“Heart rate variability biofeedback based on variation in heart rate corresponding to breathing has been shown to be effective in treating numerous conditions, including reducing (nonclinical) stress, anxiety, depression, anger, and posttraumatic stress disorder in veterans and in some instances enhancing athletic performance. Of course, the validity and reliability of the commercially available apps and devices are potential significant limitations, as well as the stability of the user’s technique,” Dr. Bergeron said.

“It’s also been recognized that low-level aerobic exercise treatment normalizes the cerebrovascular physiological dysfunction in patients with concussion by increasing CO₂ sensitivity, which normalizes exercise ventilation and cerebral blood flow and thus reduces some symptoms,” Dr. Bergeron added.

“The combination of treatments is likely the novel aspect, which makes sense because brain injury is complex, and effective interventions need to utilize a complex, integrated biological systems approach across the multiple interdependent domains of influence,” Dr. Bergeron said.

The study was supported by the nonprofit Woodcock Institute at Texas Woman’s University. Dr. Moore, Dr. Bergeron, and Dr. Posas have disclosed no relevant financial relationships.

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

A combination of gradual aerobic exercise and breathing practice can help ease persistent postconcussive symptoms, preliminary findings from a new study suggest.

Heart rate variability biofeedback (HRVB) and progressive aerobic exercise (PAE) were each helpful on their own, but combining them led to even greater improvement in cognition, depression, and mood.

“Managing persistent concussion symptoms is particularly challenging as there are no standard therapies,” study investigator R. Davis Moore, PhD, from the University of South Carolina, Columbia, said in a news release.

“These therapies are inexpensive, easy to implement, and can be self-administered, making them feasible and accessible for everyone with persistent symptoms,” Dr. Moore noted.

The study was released early, ahead of its scheduled presentation in Boston at the annual meeting of the American Academy of Neurology.
 

Targeting autonomic dysfunction

Concussion can affect the autonomic nervous system, and it is “increasingly clear that this underlies the inability to tolerate exercise, problems with thinking skills, and mood issues in those with persisting symptoms,” Dr. Moore explained.

Preliminary research suggests that HRVB and PAE can improve cardio-autonomic dysfunction and clinical symptoms. However, until now, no study has evaluated whether there is additional benefit from combining the two.

The investigators randomly assigned 30 teens with postconcussive symptoms that had lasted more than 1 month to a 6-week intervention consisting of either HRVB, PAE, or HRVB plus PAE.

The HRVB group practiced resonant-frequency breathing using a handheld biofeedback device for 20 minutes 4 nights a week. The PAE group completed a 3-day-a-week aerobic exercise protocol that gradually increased in intensity and duration. The HRVB plus PAE group did both. Concussion symptoms, HRV, cognition, and mood were assessed at baseline and again 6 weeks later.

All participants experienced improvement in sleep, mood, cognition, and autonomic function, but those who received the combined biofeedback and exercise intervention experienced greater improvements than peers who engaged in exercise or received biofeedback alone.

The study’s top-line results, which were released ahead of the presentation, show that HRVB plus PAE is associated with a twofold greater reduction in symptom severity, compared with PAE only, and a 1.3 times greater reduction in symptom severity, compared with HRVB only.

Similarly, HRVB plus PAE led to a 1.2 times greater reduction in symptoms of depression, compared with PAE only, and a 1.3 times greater reduction, compared with HRVB only.

The combined group also experienced more than 1.4 times the reduction in total mood disturbance than was provided by exercise or biofeedback alone.

The combined group also experienced significantly greater improvements in attention and working memory, as well as greater changes in metrics of HRV, than the groups that participated in exercise or biofeedback alone.

Dr. Moore and colleagues caution that the current results are preliminary and that future studies are needed with larger groups of people.

A limitation of the study was that it did not include a control group of people with persistent postconcussive symptoms who received no intervention.
 

Complex problem

Commenting on the findings, neuroscientist José Posas, MD, director of the Ochsner Neurology Residency Program, New Orleans, who wasn’t involved in the study, said these preliminary results are “promising” but cited the small number of participants as a limitation.

Dr. Posas said the results “fit with what’s known about the role of postconcussion autonomic dysfunction in persisting postconcussive symptoms.

“Managing persistent concussion symptoms can be challenging,” he added, and this study supports “exercise as medicine” as well as taking a “mind-body, holistic approach” to postconcussion recovery, said Dr. Posas.

Also weighing in, Michael F. Bergeron, PhD, clinical and scientific advisor, Department of Performance Health, Women’s Tennis Association, noted that “each of these therapeutic interventions has been around for some time now. Neither is new.

“Heart rate variability biofeedback based on variation in heart rate corresponding to breathing has been shown to be effective in treating numerous conditions, including reducing (nonclinical) stress, anxiety, depression, anger, and posttraumatic stress disorder in veterans and in some instances enhancing athletic performance. Of course, the validity and reliability of the commercially available apps and devices are potential significant limitations, as well as the stability of the user’s technique,” Dr. Bergeron said.

“It’s also been recognized that low-level aerobic exercise treatment normalizes the cerebrovascular physiological dysfunction in patients with concussion by increasing CO₂ sensitivity, which normalizes exercise ventilation and cerebral blood flow and thus reduces some symptoms,” Dr. Bergeron added.

“The combination of treatments is likely the novel aspect, which makes sense because brain injury is complex, and effective interventions need to utilize a complex, integrated biological systems approach across the multiple interdependent domains of influence,” Dr. Bergeron said.

The study was supported by the nonprofit Woodcock Institute at Texas Woman’s University. Dr. Moore, Dr. Bergeron, and Dr. Posas have disclosed no relevant financial relationships.

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

Adverse childhood experiences (ACEs) are associated with increased motor and nonmotor symptoms of Parkinson’s disease (PD) and reduced quality of life (QOL), new research shows.

Results of the first study to evaluate the relationship between childhood trauma and PD investigators found that the relationship appears to be dose dependent. Patients with PD who reported more than one ACE all experienced a statistically significant decrease in QOL, and for each additional ACE, there was significant worsening of motor symptoms.

This study supports a recent-call to-action paper in JAMA Neurology encouraging adoption of “trauma-informed neurology,” study investigator Indu Subramanian, MD, clinical professor, department of neurology, University of California, Los Angeles, said in an interview.

“We need to start asking about ACEs in everyone. It should be part of our medical intake,” said Dr. Subramanian, who is also the director of the Southwest Parkinson’s Disease Research, Education, and Clinical Center, West Los Angeles Veterans Affairs Medical Center.

The study was published online in Neurology: Clinical Practice.
 

Hard on the mind and body

A robust body of literature has clearly established a connection between ACEs, which include physical and emotional abuse, neglect, and household dysfunction, and negative physical health outcomes across the lifespan. These include stroke, dementia, diabetes, cancer, cardiovascular disease, autoimmune disorders, hypertension, and premature death as well as psychosocial health outcomes such as anxiety, depression, substance use, and suicide.

However, until now, the effects of childhood trauma have not been evaluated in a PD population.

As part of the MVP study, 712 adults with PD responded to an online survey asking about childhood trauma.

As anticipated, patients with the least reported childhood trauma reported the highest current QOL and lowest patient-reported motor and nonmotor symptom burden compared with peers with higher reported childhood trauma, the researchers reported.

PD symptom burden increased and QOL decreased as the number of ACEs increased.

Patients with ACE scores of 4 or higher reported greater PD symptom severity for 45% of the variables assessed, including apathy, muscle pain, daytime sleepiness, restless leg syndrome, depression, fatigue, comprehension, and anxiety (P < .05), compared with peers with trauma scores of 0.

Limitations of the study included the cross-sectional nature, which prevents making any causal determinations. Also, the ACE questionnaire, because it is self-reported and a retrospective collection of data, introduces the risk for recall bias. In addition, 65% of respondents were women, and racial and ethnic minority groups were not well represented.

Looking ahead, Dr. Subramanian and coauthors believe future research should “attempt to include more diverse populations, attempt improve the response rate of these sensitive questions and, most importantly, determine whether the adverse outcomes associated with childhood trauma can be mitigated with lifestyle modification, psychosocial support, and intervention in adulthood.”

“As a trauma-informed approach, something sorely lacking yet needed in the field of movement disorders, clinicians can proactively screen for ACEs while being mindful to avoid retraumatization,” they suggested. “They can begin to identify how ACEs may physiologically contribute to PD symptom and focus on targeting appropriate interventions that may improve outcomes.”
 

Life experiences matter

In a comment, Michael S. Okun, MD, medical advisor, Parkinson’s Foundation, and director of the Norman Fixel Institute for Neurological Diseases, University of Florida Health, Gainesville, said that “the idea that childhood trauma could be associated with a mild increase in severity of Parkinson’s symptoms such as apathy, pain, sleepiness and depression is fascinating.”

“We should however temper our enthusiasm for the results of this study because they were obtained through a direct patient survey, and not collected from large well characterized medical database,” Dr. Okun said.

He added” “If the data on childhood trauma and Parkinson’s can be replicated, we must ask why this could be?

“For Parkinson clinicians this as a reminder of how important obtaining a complete life history can be when strategizing on a plan to reduce motor and nonmotor Parkinson symptoms. Life experiences matter and can impact symptoms,” Dr. Okun said.

The MVP study was initiated with support of the National Center for Complementary and Integrative Health. The ongoing data collection has been supported by a donation from Sondra and Bill Fondren. Dr. Subramanian and Dr. Okun disclosed no potential conflicts of interest.

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

Adverse childhood experiences (ACEs) are associated with increased motor and nonmotor symptoms of Parkinson’s disease (PD) and reduced quality of life (QOL), new research shows.

Results of the first study to evaluate the relationship between childhood trauma and PD investigators found that the relationship appears to be dose dependent. Patients with PD who reported more than one ACE all experienced a statistically significant decrease in QOL, and for each additional ACE, there was significant worsening of motor symptoms.

This study supports a recent-call to-action paper in JAMA Neurology encouraging adoption of “trauma-informed neurology,” study investigator Indu Subramanian, MD, clinical professor, department of neurology, University of California, Los Angeles, said in an interview.

“We need to start asking about ACEs in everyone. It should be part of our medical intake,” said Dr. Subramanian, who is also the director of the Southwest Parkinson’s Disease Research, Education, and Clinical Center, West Los Angeles Veterans Affairs Medical Center.

The study was published online in Neurology: Clinical Practice.
 

Hard on the mind and body

A robust body of literature has clearly established a connection between ACEs, which include physical and emotional abuse, neglect, and household dysfunction, and negative physical health outcomes across the lifespan. These include stroke, dementia, diabetes, cancer, cardiovascular disease, autoimmune disorders, hypertension, and premature death as well as psychosocial health outcomes such as anxiety, depression, substance use, and suicide.

However, until now, the effects of childhood trauma have not been evaluated in a PD population.

As part of the MVP study, 712 adults with PD responded to an online survey asking about childhood trauma.

As anticipated, patients with the least reported childhood trauma reported the highest current QOL and lowest patient-reported motor and nonmotor symptom burden compared with peers with higher reported childhood trauma, the researchers reported.

PD symptom burden increased and QOL decreased as the number of ACEs increased.

Patients with ACE scores of 4 or higher reported greater PD symptom severity for 45% of the variables assessed, including apathy, muscle pain, daytime sleepiness, restless leg syndrome, depression, fatigue, comprehension, and anxiety (P < .05), compared with peers with trauma scores of 0.

Limitations of the study included the cross-sectional nature, which prevents making any causal determinations. Also, the ACE questionnaire, because it is self-reported and a retrospective collection of data, introduces the risk for recall bias. In addition, 65% of respondents were women, and racial and ethnic minority groups were not well represented.

Looking ahead, Dr. Subramanian and coauthors believe future research should “attempt to include more diverse populations, attempt improve the response rate of these sensitive questions and, most importantly, determine whether the adverse outcomes associated with childhood trauma can be mitigated with lifestyle modification, psychosocial support, and intervention in adulthood.”

“As a trauma-informed approach, something sorely lacking yet needed in the field of movement disorders, clinicians can proactively screen for ACEs while being mindful to avoid retraumatization,” they suggested. “They can begin to identify how ACEs may physiologically contribute to PD symptom and focus on targeting appropriate interventions that may improve outcomes.”
 

Life experiences matter

In a comment, Michael S. Okun, MD, medical advisor, Parkinson’s Foundation, and director of the Norman Fixel Institute for Neurological Diseases, University of Florida Health, Gainesville, said that “the idea that childhood trauma could be associated with a mild increase in severity of Parkinson’s symptoms such as apathy, pain, sleepiness and depression is fascinating.”

“We should however temper our enthusiasm for the results of this study because they were obtained through a direct patient survey, and not collected from large well characterized medical database,” Dr. Okun said.

He added” “If the data on childhood trauma and Parkinson’s can be replicated, we must ask why this could be?

“For Parkinson clinicians this as a reminder of how important obtaining a complete life history can be when strategizing on a plan to reduce motor and nonmotor Parkinson symptoms. Life experiences matter and can impact symptoms,” Dr. Okun said.

The MVP study was initiated with support of the National Center for Complementary and Integrative Health. The ongoing data collection has been supported by a donation from Sondra and Bill Fondren. Dr. Subramanian and Dr. Okun disclosed no potential conflicts of interest.

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

Adverse childhood experiences (ACEs) are associated with increased motor and nonmotor symptoms of Parkinson’s disease (PD) and reduced quality of life (QOL), new research shows.

Results of the first study to evaluate the relationship between childhood trauma and PD investigators found that the relationship appears to be dose dependent. Patients with PD who reported more than one ACE all experienced a statistically significant decrease in QOL, and for each additional ACE, there was significant worsening of motor symptoms.

This study supports a recent-call to-action paper in JAMA Neurology encouraging adoption of “trauma-informed neurology,” study investigator Indu Subramanian, MD, clinical professor, department of neurology, University of California, Los Angeles, said in an interview.

“We need to start asking about ACEs in everyone. It should be part of our medical intake,” said Dr. Subramanian, who is also the director of the Southwest Parkinson’s Disease Research, Education, and Clinical Center, West Los Angeles Veterans Affairs Medical Center.

The study was published online in Neurology: Clinical Practice.
 

Hard on the mind and body

A robust body of literature has clearly established a connection between ACEs, which include physical and emotional abuse, neglect, and household dysfunction, and negative physical health outcomes across the lifespan. These include stroke, dementia, diabetes, cancer, cardiovascular disease, autoimmune disorders, hypertension, and premature death as well as psychosocial health outcomes such as anxiety, depression, substance use, and suicide.

However, until now, the effects of childhood trauma have not been evaluated in a PD population.

As part of the MVP study, 712 adults with PD responded to an online survey asking about childhood trauma.

As anticipated, patients with the least reported childhood trauma reported the highest current QOL and lowest patient-reported motor and nonmotor symptom burden compared with peers with higher reported childhood trauma, the researchers reported.

PD symptom burden increased and QOL decreased as the number of ACEs increased.

Patients with ACE scores of 4 or higher reported greater PD symptom severity for 45% of the variables assessed, including apathy, muscle pain, daytime sleepiness, restless leg syndrome, depression, fatigue, comprehension, and anxiety (P < .05), compared with peers with trauma scores of 0.

Limitations of the study included the cross-sectional nature, which prevents making any causal determinations. Also, the ACE questionnaire, because it is self-reported and a retrospective collection of data, introduces the risk for recall bias. In addition, 65% of respondents were women, and racial and ethnic minority groups were not well represented.

Looking ahead, Dr. Subramanian and coauthors believe future research should “attempt to include more diverse populations, attempt improve the response rate of these sensitive questions and, most importantly, determine whether the adverse outcomes associated with childhood trauma can be mitigated with lifestyle modification, psychosocial support, and intervention in adulthood.”

“As a trauma-informed approach, something sorely lacking yet needed in the field of movement disorders, clinicians can proactively screen for ACEs while being mindful to avoid retraumatization,” they suggested. “They can begin to identify how ACEs may physiologically contribute to PD symptom and focus on targeting appropriate interventions that may improve outcomes.”
 

Life experiences matter

In a comment, Michael S. Okun, MD, medical advisor, Parkinson’s Foundation, and director of the Norman Fixel Institute for Neurological Diseases, University of Florida Health, Gainesville, said that “the idea that childhood trauma could be associated with a mild increase in severity of Parkinson’s symptoms such as apathy, pain, sleepiness and depression is fascinating.”

“We should however temper our enthusiasm for the results of this study because they were obtained through a direct patient survey, and not collected from large well characterized medical database,” Dr. Okun said.

He added” “If the data on childhood trauma and Parkinson’s can be replicated, we must ask why this could be?

“For Parkinson clinicians this as a reminder of how important obtaining a complete life history can be when strategizing on a plan to reduce motor and nonmotor Parkinson symptoms. Life experiences matter and can impact symptoms,” Dr. Okun said.

The MVP study was initiated with support of the National Center for Complementary and Integrative Health. The ongoing data collection has been supported by a donation from Sondra and Bill Fondren. Dr. Subramanian and Dr. Okun disclosed no potential conflicts of interest.

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