Pediatrics

Black and Latinx children are more likely to be evaluated for child abuse and referred to child protective services than their White peers, according to research discussed by Tiffani J. Johnson, MD, an assistant professor of emergency medicine at the University of California, Davis.

Darrin Klimek/Thinkstock

“These disparities in child abuse evaluation and reporting are bidirectional,” she said. “We also recognize that abuse is more likely to be unrecognized in White children.”

Dr. Johnson presented data on the health disparities in child abuse reporting in a session at the annual meeting of the American Academy of Pediatrics, held virtually this year. Health care disparities, as defined by the National Academy of Sciences, refers to differences in the quality of care between minority and nonminority populations that are not caused by clinical appropriateness, access, need, or patient preference, she explained. Instead, they result from discrimination, bias, stereotyping, and uncertainty.
 

Disparities lead to harm in all children

For example, a 2018 systematic review found that Black and other non-White children were significantly more likely than White children to be evaluated with a skeletal survey. In one of the studies included, at a large urban academic center, Black and Latinx children with accidental fractures were 8.75 times more likely to undergo a skeletal survey than White children and 4.3 times more likely to be reported to child protective services.

“And let me emphasize that these are children who were ultimately found to have accidental fractures,” Dr. Johnson said.

Meanwhile, in an analysis of known cases of head trauma, researchers found that abuse was missed in 37% of White children, compared with 19% of non-White children.

“These only represent the tip of the iceberg as a true number of cases of abuse may never really be detected because some cases are still unknown,” Dr. Johnson told attendees. And the harm of these disparities runs in both directions.

“Failing to diagnose abuse in White children clearly puts them at increased risk for return visits and return evaluations for repeated abuse by the perpetrators,” she said. But harm also can result from overreporting and investigation, including psychological trauma and a waste of limited resources. Overinvestigation also can erode family-physician relationships and perpetuate distrust of medical care in communities of color.

Yet at the same time, it’s clear that Black children, adolescents, and young adults are not protected from harm in society more generally, when at home, where they learn, or where they play, Dr. Johnson said, referencing the deaths of Breonna Taylor and Tamir Rice as examples.

KatarzynaBialasiewicz/Thinkstock

“And now we’re seeing increased evidence that children are not protected in the health care center when we think about the many disparities that have been identified in the care and outcomes of children, including the disproportionality in terms of child abuse evaluation and referrals,” Dr. Johnson said.

Racism is a root cause of that harm to Black children, she said, as the systemic structure of opportunities unfairly disadvantages some individuals and communities while unfairly advantaging others, thereby “sapping the strength of the whole society through the waste of human resources.”

Tonya Chaffee, MD, MPH, a clinical professor of health sciences at the University of California, San Francisco, who attended the session, said she particularly appreciated “seeing data on which racial/ethnic populations have child abuse reports made and the disparities that exist that are similar to what we are noticing in our own institution.”
 

Role of individual-level implicit bias and racism

While institutional and structural racism play a substantial role in health care disparities, Dr. Johnson focused primarily on the impact of personal racism when it comes to child abuse evaluations, through overt discrimination, explicit bias, implicit bias, and stigmatization. The most challenging of these to identify and acknowledge is often implicit bias, a tendency to believe, even unconsciously, that some people or ideas are better than others, which results in unfair treatment.

For example, a 2016 study found that half of medical students and residents held at least one biological belief about differences between Black and White individuals that was actually false, such as Black people having more pain tolerance or stronger bones than White people, which then affected treatment recommendations.

“Implicit bias refers to our attitudes that lie below the surface, but they can still influence our behaviors,” Dr. Johnson explained. She encouraged providers to take the implicit bias test online to learn about their own unrecognized implicit biases. These biases have a hand in influencing decisions particularly in fast-paced environments where cognitive load is high – such as EDs, where many child abuse evaluations occur.

For example, in one study Dr. Johnson led, the researchers measured implicit bias in participants before and after an ED shift to assess how cognitive load affected bias. They found that participants who care for more than 10 patients, the average score for implicit bias increased.

Similarly, “when the ED was more overcrowded, there was also increased bias at the end of the shift, compared to the beginning of the shift,” Dr. Johnson said. She asked clinicians to take into consideration that at the start of the shift, they may feel well rested and freshly caffeinated, able to suppress or overcome the biases that they know they have.

“But our biases [are] more likely to come into play with every subsequent decision that we make throughout the day when we’re engaged in clinical encounters,” such as who does and does not receive a skeletal survey or get referred to child protective services, she said.

In another study where she hypothesized that resident physicians would have less bias on the child race implicit bias test than on the adult race one, Dr. Johnson reported that 85% of 91 residents working in an ED had an implicit pro-White/anti-Black bias in the test on adult race, but an even higher bias score – 91% – with child race.

Research has found that even children’s names can conjure implicit bias when it comes to stereotypically “White-sounding” names versus stereotypically “Black-sounding names.”

The implicit bias among clinicians extends beyond care of different children. Research has also identified association between higher implicit bias scores and less interpersonal treatment, less supportive communication, less patient-centered communication, poorer patient ratings of satisfaction, and greater patient-reported difficulty with following recommendations, Dr. Johnson said.

“I want you to think about that because I know that when we’re engaging with parents and making decisions about whether or not we’re going to do a skeletal survey or report someone for it, there is a lot of subjectivity that comes into play with how you’re interacting with families,” Dr. Johnson said. Those verbal and nonverbal cues may be triggering to parents, which then affects your interaction with them. Further, research shows that these biases may impact treatment decisions as well.

Personal-mediated racism also shows up in the use of stigmatizing language, Dr. Johnson said.

“When providers read stigmatizing language in the patient’s medical records, it was associated with them having more negative attitudes about that patient,” which then influenced their clinical decision-making, she said. “So when providers got primed with stigmatizing language, they subsequently had less aggressive pain management for those patients.”
 

Clinical implications for patient care

Dr. Johnson encouraged attendees to be careful about the language and tone they use in communicating with other health care providers and during documentation in medical records. Disparities in child abuse evaluation and reporting tend to be greater in EDs with more subjective conditions, whereas disparities are lower in departments with more established protocols.

She recommended several changes to practice that can reduce the impact of implicit bias. Universal screening for child abuse can increase how many injuries are found, but usually at the cost of increased resources and radiation. Another option is use of validated clinical decision support rules to identify who is at high or low risk for maltreatment, something Dr. Johnson is working on in her research.

But it’s also important for individual providers to confront their personal biases. Evidence-based strategies for reducing bias include perspective taking, focusing on common identities with patients, using counter-stereotypical imaging, seeking increased opportunity for cross-cultural contact, and mindfulness meditation.

“When you interact with people of different backgrounds, it helps to reduce the impact of stereotypes in society about those individuals,” Dr. Johnson told attendees. It’s also important to recognize how diversity in your clinical team can reduce bias.

“We need to work with our institutions to confront racial biases in child abuse reporting and develop quality improvement projects to ensure reporting is done objectively,” Dr. Chaffee said in an interview after attending the session. “This will require training and likely policy changes, including how reports are made to child welfare and/or the police moving forward.”

Black and Latinx children are more likely to be evaluated for child abuse and referred to child protective services than their White peers, according to research discussed by Tiffani J. Johnson, MD, an assistant professor of emergency medicine at the University of California, Davis.

Darrin Klimek/Thinkstock

“These disparities in child abuse evaluation and reporting are bidirectional,” she said. “We also recognize that abuse is more likely to be unrecognized in White children.”

Dr. Johnson presented data on the health disparities in child abuse reporting in a session at the annual meeting of the American Academy of Pediatrics, held virtually this year. Health care disparities, as defined by the National Academy of Sciences, refers to differences in the quality of care between minority and nonminority populations that are not caused by clinical appropriateness, access, need, or patient preference, she explained. Instead, they result from discrimination, bias, stereotyping, and uncertainty.
 

Disparities lead to harm in all children

For example, a 2018 systematic review found that Black and other non-White children were significantly more likely than White children to be evaluated with a skeletal survey. In one of the studies included, at a large urban academic center, Black and Latinx children with accidental fractures were 8.75 times more likely to undergo a skeletal survey than White children and 4.3 times more likely to be reported to child protective services.

“And let me emphasize that these are children who were ultimately found to have accidental fractures,” Dr. Johnson said.

Meanwhile, in an analysis of known cases of head trauma, researchers found that abuse was missed in 37% of White children, compared with 19% of non-White children.

“These only represent the tip of the iceberg as a true number of cases of abuse may never really be detected because some cases are still unknown,” Dr. Johnson told attendees. And the harm of these disparities runs in both directions.

“Failing to diagnose abuse in White children clearly puts them at increased risk for return visits and return evaluations for repeated abuse by the perpetrators,” she said. But harm also can result from overreporting and investigation, including psychological trauma and a waste of limited resources. Overinvestigation also can erode family-physician relationships and perpetuate distrust of medical care in communities of color.

Yet at the same time, it’s clear that Black children, adolescents, and young adults are not protected from harm in society more generally, when at home, where they learn, or where they play, Dr. Johnson said, referencing the deaths of Breonna Taylor and Tamir Rice as examples.

KatarzynaBialasiewicz/Thinkstock

“And now we’re seeing increased evidence that children are not protected in the health care center when we think about the many disparities that have been identified in the care and outcomes of children, including the disproportionality in terms of child abuse evaluation and referrals,” Dr. Johnson said.

Racism is a root cause of that harm to Black children, she said, as the systemic structure of opportunities unfairly disadvantages some individuals and communities while unfairly advantaging others, thereby “sapping the strength of the whole society through the waste of human resources.”

Tonya Chaffee, MD, MPH, a clinical professor of health sciences at the University of California, San Francisco, who attended the session, said she particularly appreciated “seeing data on which racial/ethnic populations have child abuse reports made and the disparities that exist that are similar to what we are noticing in our own institution.”
 

Role of individual-level implicit bias and racism

While institutional and structural racism play a substantial role in health care disparities, Dr. Johnson focused primarily on the impact of personal racism when it comes to child abuse evaluations, through overt discrimination, explicit bias, implicit bias, and stigmatization. The most challenging of these to identify and acknowledge is often implicit bias, a tendency to believe, even unconsciously, that some people or ideas are better than others, which results in unfair treatment.

For example, a 2016 study found that half of medical students and residents held at least one biological belief about differences between Black and White individuals that was actually false, such as Black people having more pain tolerance or stronger bones than White people, which then affected treatment recommendations.

“Implicit bias refers to our attitudes that lie below the surface, but they can still influence our behaviors,” Dr. Johnson explained. She encouraged providers to take the implicit bias test online to learn about their own unrecognized implicit biases. These biases have a hand in influencing decisions particularly in fast-paced environments where cognitive load is high – such as EDs, where many child abuse evaluations occur.

For example, in one study Dr. Johnson led, the researchers measured implicit bias in participants before and after an ED shift to assess how cognitive load affected bias. They found that participants who care for more than 10 patients, the average score for implicit bias increased.

Similarly, “when the ED was more overcrowded, there was also increased bias at the end of the shift, compared to the beginning of the shift,” Dr. Johnson said. She asked clinicians to take into consideration that at the start of the shift, they may feel well rested and freshly caffeinated, able to suppress or overcome the biases that they know they have.

“But our biases [are] more likely to come into play with every subsequent decision that we make throughout the day when we’re engaged in clinical encounters,” such as who does and does not receive a skeletal survey or get referred to child protective services, she said.

In another study where she hypothesized that resident physicians would have less bias on the child race implicit bias test than on the adult race one, Dr. Johnson reported that 85% of 91 residents working in an ED had an implicit pro-White/anti-Black bias in the test on adult race, but an even higher bias score – 91% – with child race.

Research has found that even children’s names can conjure implicit bias when it comes to stereotypically “White-sounding” names versus stereotypically “Black-sounding names.”

The implicit bias among clinicians extends beyond care of different children. Research has also identified association between higher implicit bias scores and less interpersonal treatment, less supportive communication, less patient-centered communication, poorer patient ratings of satisfaction, and greater patient-reported difficulty with following recommendations, Dr. Johnson said.

“I want you to think about that because I know that when we’re engaging with parents and making decisions about whether or not we’re going to do a skeletal survey or report someone for it, there is a lot of subjectivity that comes into play with how you’re interacting with families,” Dr. Johnson said. Those verbal and nonverbal cues may be triggering to parents, which then affects your interaction with them. Further, research shows that these biases may impact treatment decisions as well.

Personal-mediated racism also shows up in the use of stigmatizing language, Dr. Johnson said.

“When providers read stigmatizing language in the patient’s medical records, it was associated with them having more negative attitudes about that patient,” which then influenced their clinical decision-making, she said. “So when providers got primed with stigmatizing language, they subsequently had less aggressive pain management for those patients.”
 

Clinical implications for patient care

Dr. Johnson encouraged attendees to be careful about the language and tone they use in communicating with other health care providers and during documentation in medical records. Disparities in child abuse evaluation and reporting tend to be greater in EDs with more subjective conditions, whereas disparities are lower in departments with more established protocols.

She recommended several changes to practice that can reduce the impact of implicit bias. Universal screening for child abuse can increase how many injuries are found, but usually at the cost of increased resources and radiation. Another option is use of validated clinical decision support rules to identify who is at high or low risk for maltreatment, something Dr. Johnson is working on in her research.

But it’s also important for individual providers to confront their personal biases. Evidence-based strategies for reducing bias include perspective taking, focusing on common identities with patients, using counter-stereotypical imaging, seeking increased opportunity for cross-cultural contact, and mindfulness meditation.

“When you interact with people of different backgrounds, it helps to reduce the impact of stereotypes in society about those individuals,” Dr. Johnson told attendees. It’s also important to recognize how diversity in your clinical team can reduce bias.

“We need to work with our institutions to confront racial biases in child abuse reporting and develop quality improvement projects to ensure reporting is done objectively,” Dr. Chaffee said in an interview after attending the session. “This will require training and likely policy changes, including how reports are made to child welfare and/or the police moving forward.”

Black and Latinx children are more likely to be evaluated for child abuse and referred to child protective services than their White peers, according to research discussed by Tiffani J. Johnson, MD, an assistant professor of emergency medicine at the University of California, Davis.

Darrin Klimek/Thinkstock

“These disparities in child abuse evaluation and reporting are bidirectional,” she said. “We also recognize that abuse is more likely to be unrecognized in White children.”

Dr. Johnson presented data on the health disparities in child abuse reporting in a session at the annual meeting of the American Academy of Pediatrics, held virtually this year. Health care disparities, as defined by the National Academy of Sciences, refers to differences in the quality of care between minority and nonminority populations that are not caused by clinical appropriateness, access, need, or patient preference, she explained. Instead, they result from discrimination, bias, stereotyping, and uncertainty.
 

Disparities lead to harm in all children

For example, a 2018 systematic review found that Black and other non-White children were significantly more likely than White children to be evaluated with a skeletal survey. In one of the studies included, at a large urban academic center, Black and Latinx children with accidental fractures were 8.75 times more likely to undergo a skeletal survey than White children and 4.3 times more likely to be reported to child protective services.

“And let me emphasize that these are children who were ultimately found to have accidental fractures,” Dr. Johnson said.

Meanwhile, in an analysis of known cases of head trauma, researchers found that abuse was missed in 37% of White children, compared with 19% of non-White children.

“These only represent the tip of the iceberg as a true number of cases of abuse may never really be detected because some cases are still unknown,” Dr. Johnson told attendees. And the harm of these disparities runs in both directions.

“Failing to diagnose abuse in White children clearly puts them at increased risk for return visits and return evaluations for repeated abuse by the perpetrators,” she said. But harm also can result from overreporting and investigation, including psychological trauma and a waste of limited resources. Overinvestigation also can erode family-physician relationships and perpetuate distrust of medical care in communities of color.

Yet at the same time, it’s clear that Black children, adolescents, and young adults are not protected from harm in society more generally, when at home, where they learn, or where they play, Dr. Johnson said, referencing the deaths of Breonna Taylor and Tamir Rice as examples.

KatarzynaBialasiewicz/Thinkstock

“And now we’re seeing increased evidence that children are not protected in the health care center when we think about the many disparities that have been identified in the care and outcomes of children, including the disproportionality in terms of child abuse evaluation and referrals,” Dr. Johnson said.

Racism is a root cause of that harm to Black children, she said, as the systemic structure of opportunities unfairly disadvantages some individuals and communities while unfairly advantaging others, thereby “sapping the strength of the whole society through the waste of human resources.”

Tonya Chaffee, MD, MPH, a clinical professor of health sciences at the University of California, San Francisco, who attended the session, said she particularly appreciated “seeing data on which racial/ethnic populations have child abuse reports made and the disparities that exist that are similar to what we are noticing in our own institution.”
 

Role of individual-level implicit bias and racism

While institutional and structural racism play a substantial role in health care disparities, Dr. Johnson focused primarily on the impact of personal racism when it comes to child abuse evaluations, through overt discrimination, explicit bias, implicit bias, and stigmatization. The most challenging of these to identify and acknowledge is often implicit bias, a tendency to believe, even unconsciously, that some people or ideas are better than others, which results in unfair treatment.

For example, a 2016 study found that half of medical students and residents held at least one biological belief about differences between Black and White individuals that was actually false, such as Black people having more pain tolerance or stronger bones than White people, which then affected treatment recommendations.

“Implicit bias refers to our attitudes that lie below the surface, but they can still influence our behaviors,” Dr. Johnson explained. She encouraged providers to take the implicit bias test online to learn about their own unrecognized implicit biases. These biases have a hand in influencing decisions particularly in fast-paced environments where cognitive load is high – such as EDs, where many child abuse evaluations occur.

For example, in one study Dr. Johnson led, the researchers measured implicit bias in participants before and after an ED shift to assess how cognitive load affected bias. They found that participants who care for more than 10 patients, the average score for implicit bias increased.

Similarly, “when the ED was more overcrowded, there was also increased bias at the end of the shift, compared to the beginning of the shift,” Dr. Johnson said. She asked clinicians to take into consideration that at the start of the shift, they may feel well rested and freshly caffeinated, able to suppress or overcome the biases that they know they have.

“But our biases [are] more likely to come into play with every subsequent decision that we make throughout the day when we’re engaged in clinical encounters,” such as who does and does not receive a skeletal survey or get referred to child protective services, she said.

In another study where she hypothesized that resident physicians would have less bias on the child race implicit bias test than on the adult race one, Dr. Johnson reported that 85% of 91 residents working in an ED had an implicit pro-White/anti-Black bias in the test on adult race, but an even higher bias score – 91% – with child race.

Research has found that even children’s names can conjure implicit bias when it comes to stereotypically “White-sounding” names versus stereotypically “Black-sounding names.”

The implicit bias among clinicians extends beyond care of different children. Research has also identified association between higher implicit bias scores and less interpersonal treatment, less supportive communication, less patient-centered communication, poorer patient ratings of satisfaction, and greater patient-reported difficulty with following recommendations, Dr. Johnson said.

“I want you to think about that because I know that when we’re engaging with parents and making decisions about whether or not we’re going to do a skeletal survey or report someone for it, there is a lot of subjectivity that comes into play with how you’re interacting with families,” Dr. Johnson said. Those verbal and nonverbal cues may be triggering to parents, which then affects your interaction with them. Further, research shows that these biases may impact treatment decisions as well.

Personal-mediated racism also shows up in the use of stigmatizing language, Dr. Johnson said.

“When providers read stigmatizing language in the patient’s medical records, it was associated with them having more negative attitudes about that patient,” which then influenced their clinical decision-making, she said. “So when providers got primed with stigmatizing language, they subsequently had less aggressive pain management for those patients.”
 

Clinical implications for patient care

Dr. Johnson encouraged attendees to be careful about the language and tone they use in communicating with other health care providers and during documentation in medical records. Disparities in child abuse evaluation and reporting tend to be greater in EDs with more subjective conditions, whereas disparities are lower in departments with more established protocols.

She recommended several changes to practice that can reduce the impact of implicit bias. Universal screening for child abuse can increase how many injuries are found, but usually at the cost of increased resources and radiation. Another option is use of validated clinical decision support rules to identify who is at high or low risk for maltreatment, something Dr. Johnson is working on in her research.

But it’s also important for individual providers to confront their personal biases. Evidence-based strategies for reducing bias include perspective taking, focusing on common identities with patients, using counter-stereotypical imaging, seeking increased opportunity for cross-cultural contact, and mindfulness meditation.

“When you interact with people of different backgrounds, it helps to reduce the impact of stereotypes in society about those individuals,” Dr. Johnson told attendees. It’s also important to recognize how diversity in your clinical team can reduce bias.

“We need to work with our institutions to confront racial biases in child abuse reporting and develop quality improvement projects to ensure reporting is done objectively,” Dr. Chaffee said in an interview after attending the session. “This will require training and likely policy changes, including how reports are made to child welfare and/or the police moving forward.”

Poor sleep health and attention regulation problems are common in young children with atopic dermatitis (AD), and the burden intensifies with worse severity, results from a national survey demonstrated.

“We think it’s important for dermatologists and pediatricians to be monitoring children with AD for sleep and attention dysregulation,” Nina Y. Zhou said during a late-breaking research session at the Revolutionizing Atopic Dermatitis virtual symposium. “It’s also important to highlight sleep hygiene habits to improve sleep health overall.”

In an effort to determine the impact of AD severity on these symptoms in young children with AD and characterize sleep health and attention regulation behaviors, Ms. Zhou, a medical student at Northwestern University, Chicago, and colleagues drew from a national survey distributed via panel company OP4G and the National Eczema Association that was conducted with parents of 60 children with AD aged 1-5 years. Questionnaires included the Patient Reported Outcomes Measurement Information System (PROMIS) Early Childhood Sleep Health Measures to assess sleep health, the Peak Pruritus NRS to measure itch severity, and the Multidimensional Assessment Profile of Attention Regulation (MAPS-AR) to measure attention dysregulation related to inattention and hyperactivity. The researchers performed linear regression to determine the predictors of sleep health and attention dysregulation.

The mean age of 60 children was 3 years, 55% were male, 32% were black, 42% had severe disease, 42% had moderate disease, and 16% had mild disease. Children with more extensive AD were significantly more likely to report worse sleep disturbance. The proportion of children who reported sleep disturbance on at least 5 nights per week was 67% among those with severe AD, 24% among those with moderate AD, and 0% among those with mild AD.

In addition, 72% of parents of children with severe AD reported trouble paying attention at least 3 times per week “no matter what was going on,” compared with 24% of those with moderate AD and none of those with mild AD.

Parents of children with more severe AD reported more itch-related burden and significantly decreased quality of life for their children. For example, 76% of parents with children who had severe AD reported “because of itch, their child was frustrated,” compared to 44% of those with moderate AD and 10% with mild AD.

In fully adjusted linear regression analysis, the strongest predictors of sleep disturbance were AD severity (unstandardized beta value = 0.79, P less than .01) and being Black (unstandardized beta value = 3.89, P = .03). AD severity (unstandardized beta value = 1.22, P less than .01) and being Black (unstandardized beta value = 7.79, P less than .01) also predicted more attention dysregulation.

Household income appeared to differ significantly based on AD severity groups. “If you have mild AD, you are more likely to come from a higher income household,” Ms. Zhou said.

She concluded her presentation by calling for future studies with larger samples sizes to establish causality and directional effects between AD severity, itch, sleep, race, and attention.

The study was funded by the Agency for Healthcare Research and Quality. Ms. Zhou reported having no financial disclosures.

[email protected]

Poor sleep health and attention regulation problems are common in young children with atopic dermatitis (AD), and the burden intensifies with worse severity, results from a national survey demonstrated.

“We think it’s important for dermatologists and pediatricians to be monitoring children with AD for sleep and attention dysregulation,” Nina Y. Zhou said during a late-breaking research session at the Revolutionizing Atopic Dermatitis virtual symposium. “It’s also important to highlight sleep hygiene habits to improve sleep health overall.”

In an effort to determine the impact of AD severity on these symptoms in young children with AD and characterize sleep health and attention regulation behaviors, Ms. Zhou, a medical student at Northwestern University, Chicago, and colleagues drew from a national survey distributed via panel company OP4G and the National Eczema Association that was conducted with parents of 60 children with AD aged 1-5 years. Questionnaires included the Patient Reported Outcomes Measurement Information System (PROMIS) Early Childhood Sleep Health Measures to assess sleep health, the Peak Pruritus NRS to measure itch severity, and the Multidimensional Assessment Profile of Attention Regulation (MAPS-AR) to measure attention dysregulation related to inattention and hyperactivity. The researchers performed linear regression to determine the predictors of sleep health and attention dysregulation.

The mean age of 60 children was 3 years, 55% were male, 32% were black, 42% had severe disease, 42% had moderate disease, and 16% had mild disease. Children with more extensive AD were significantly more likely to report worse sleep disturbance. The proportion of children who reported sleep disturbance on at least 5 nights per week was 67% among those with severe AD, 24% among those with moderate AD, and 0% among those with mild AD.

In addition, 72% of parents of children with severe AD reported trouble paying attention at least 3 times per week “no matter what was going on,” compared with 24% of those with moderate AD and none of those with mild AD.

Parents of children with more severe AD reported more itch-related burden and significantly decreased quality of life for their children. For example, 76% of parents with children who had severe AD reported “because of itch, their child was frustrated,” compared to 44% of those with moderate AD and 10% with mild AD.

In fully adjusted linear regression analysis, the strongest predictors of sleep disturbance were AD severity (unstandardized beta value = 0.79, P less than .01) and being Black (unstandardized beta value = 3.89, P = .03). AD severity (unstandardized beta value = 1.22, P less than .01) and being Black (unstandardized beta value = 7.79, P less than .01) also predicted more attention dysregulation.

Household income appeared to differ significantly based on AD severity groups. “If you have mild AD, you are more likely to come from a higher income household,” Ms. Zhou said.

She concluded her presentation by calling for future studies with larger samples sizes to establish causality and directional effects between AD severity, itch, sleep, race, and attention.

The study was funded by the Agency for Healthcare Research and Quality. Ms. Zhou reported having no financial disclosures.

[email protected]

Poor sleep health and attention regulation problems are common in young children with atopic dermatitis (AD), and the burden intensifies with worse severity, results from a national survey demonstrated.

“We think it’s important for dermatologists and pediatricians to be monitoring children with AD for sleep and attention dysregulation,” Nina Y. Zhou said during a late-breaking research session at the Revolutionizing Atopic Dermatitis virtual symposium. “It’s also important to highlight sleep hygiene habits to improve sleep health overall.”

In an effort to determine the impact of AD severity on these symptoms in young children with AD and characterize sleep health and attention regulation behaviors, Ms. Zhou, a medical student at Northwestern University, Chicago, and colleagues drew from a national survey distributed via panel company OP4G and the National Eczema Association that was conducted with parents of 60 children with AD aged 1-5 years. Questionnaires included the Patient Reported Outcomes Measurement Information System (PROMIS) Early Childhood Sleep Health Measures to assess sleep health, the Peak Pruritus NRS to measure itch severity, and the Multidimensional Assessment Profile of Attention Regulation (MAPS-AR) to measure attention dysregulation related to inattention and hyperactivity. The researchers performed linear regression to determine the predictors of sleep health and attention dysregulation.

The mean age of 60 children was 3 years, 55% were male, 32% were black, 42% had severe disease, 42% had moderate disease, and 16% had mild disease. Children with more extensive AD were significantly more likely to report worse sleep disturbance. The proportion of children who reported sleep disturbance on at least 5 nights per week was 67% among those with severe AD, 24% among those with moderate AD, and 0% among those with mild AD.

In addition, 72% of parents of children with severe AD reported trouble paying attention at least 3 times per week “no matter what was going on,” compared with 24% of those with moderate AD and none of those with mild AD.

Parents of children with more severe AD reported more itch-related burden and significantly decreased quality of life for their children. For example, 76% of parents with children who had severe AD reported “because of itch, their child was frustrated,” compared to 44% of those with moderate AD and 10% with mild AD.

In fully adjusted linear regression analysis, the strongest predictors of sleep disturbance were AD severity (unstandardized beta value = 0.79, P less than .01) and being Black (unstandardized beta value = 3.89, P = .03). AD severity (unstandardized beta value = 1.22, P less than .01) and being Black (unstandardized beta value = 7.79, P less than .01) also predicted more attention dysregulation.

Household income appeared to differ significantly based on AD severity groups. “If you have mild AD, you are more likely to come from a higher income household,” Ms. Zhou said.

She concluded her presentation by calling for future studies with larger samples sizes to establish causality and directional effects between AD severity, itch, sleep, race, and attention.

The study was funded by the Agency for Healthcare Research and Quality. Ms. Zhou reported having no financial disclosures.

[email protected]

Caring for LGBTQ+ pediatric patients often requires physicians to consider issues – such as preservation of fertility for transgender youth and resource allocation to sexual-minority youth in the foster-care system – that they may not think about as frequently with their other patients.

monkeybusinessimages/Getty Images

“It’s important to engage transgender and gender-diverse youth and families in fertility counseling early in their gender affirmation process,” but it does not happen as often as it should, said Jason Rafferty, MD (he/him/his), a clinical assistant professor of psychiatry and human behavior at the Warren Alpert Medical School of Brown University, Providence, R.I. Dr. Rafferty discussed two studies at the annual meeting of the American Academy of Pediatrics, held virtually this year: one on fertility outcomes among a small transgender sample and another finding that sexual-minority youth are 2.5 times more likely to be involved in the foster-care system.

“We need to recognize and address disparities in health that place sexual-minority youth at increased risk for child welfare involvement,” he told attendees.
 

Fertility preservation and counseling for transgender patients

Evidence suggests gender-affirming hormone treatment affects gonadal structures and functions in ways that may decrease fertility potential, Dr. Rafferty said. “Yet, there’s very little [research] into the reversibility or thresholds above which fertility potential is affected.”

The World Professional Association for Transgender Health (WPATH) recommends that doctors discuss the possible adverse health effects of feminizing or masculinizing treatments and the patient’s reproductive options before starting hormone therapy, although the extent to which this therapy may impair fertility isn’t known.

The first study Dr. Rafferty discussed was an assessment of semen cryopreservation outcomes among youth asserting a female identity. The researchers conducted a retrospective chart review on a convenience sample of 11 transgender and gender-diverse adolescents and young adults who had been referred for fertility preservation between January 2015 and September 2018 at the University of Pittsburgh Medical Center Children’s Hospital and the UPMC Magee-Womens Hospital in Pittsburgh.

Of the 11, 1 did not provide a sample, and another discarded their sample after 4 months. The seven patients without prior gender-affirming hormone treatment (average age 19 at time of fertility consultation) were all able to produce a semen sample, which showed normal parameters, except for some abnormal morphology. The significance of that one abnormal finding was unclear without a control group, Dr. Rafferty said. All seven began gonadotropin-releasing hormone (GnRH) agonist therapy, and four also began estradiol therapy, although Dr. Rafferty questioned why GnRH agonist therapy was started at such late ages.

Regardless, he said, the takeaway from this first group was the efficiency and effectiveness of getting a semen sample before beginning gender-affirming hormone therapy. The second group offered a different takeaway.

“What I think is probably the most unique aspect of this study is this second group of two individuals who had previously received hormones or blockers,” Dr. Rafferty told attendees. The first patient was 13 years of age at gender dysphoria onset and 18 years at the time of their fertility consultation. They had been on GnRH agonists for 6 months before semen collection. Their first sample, at 3 months after discontinuing hormones, was low-quality, but they did produce a viable sample 2 months later.

The other patient, who underwent fertility consultation at age 19, had taken estrogen and spironolactone for 26 months before semen collection and were not able to produce sperm 4 months after stopping the treatment. They did not try again because they underwent an orchiectomy.

Despite the small sample size and lack of confounding data, such as smoking and stress, the study remains the first to show successful sampling after gender-affirming hormone therapy in a teen, Dr. Rafferty said. It also shows that sampling after beginning hormone therapy may require discontinuation for several months before a successful sample is possible, thereby supporting WPATH’s recommendation for early fertility counseling.

“However, the standard of providing fertility counseling before intervention does not always occur,” Dr. Rafferty said, citing research that found low percentages of teens had received fertility counseling or discussed negative effects of therapy on fertility prior to starting it. These low numbers may result from changes in youths’ interest in fertility throughout development, but they could also relate to youths’ reluctance to discuss family planning while they feel uncomfortable in their bodies.

“My experience, and there is some empirical evidence for this, is that many transgender and gender-diverse youth feel more comfortable conceptualizing and pursuing intimate partner relationships and family planning after they start gender affirmation interventions,” Dr. Rafferty said. The stress associated with gender dysphoria can further complicate fertility discussions, and providers have to consider whether it’s more stressful to hold off on gender-affirming hormone therapy until the patient gets a successful semen sample or to start therapy and then discontinue for several months to get a sample later.

While decisions about fertility services should be fully up to the patient, in reality, multiple barriers – such as high cost, low insurance coverage, a dearth of specialists who can do the procedures, and inaccurate assumptions about transgender people’s interest in family planning – complicate the decision,.

“Systemically denying a marginalized population the ability to reproduce, or at least the ability to make a free choice about reproduction and family planning, is a reproductive justice issue that’s not getting the attention it deserves,” Dr. Rafferty said.

Clair Kronk, BSc, a session attendee from the University of Cincinnati College of Medicine and Cincinnati Children’s Hospital and Medical Center, said in an interview that she appreciated the session even while she lamented the lack of adequate evidence on transgender and gender-diverse care.

“I do feel like there are a lot of provider-based questions with no sufficient guidelines right now when it comes to transgender care,” Ms. Kronk said. “Despite being nearly a century old, treatment of trans patients is somehow still a ‘Wild West’ of medical care, which is sad to see.” She is grateful to see attention finally reaching this population.

“It is imperative that medical institutions focus on real, advanceable diversity, equity, and inclusion initiatives which center marginalized groups,” she said. “Centering minoritized and marginalized peoples in improving care is the only way lasting change will happen.”
 

Sexual-minority youth in foster care

The second study Dr. Rafferty discussed was the first nationally representative systemic assessment of the prevalence of sexual-minority youth in foster care, child welfare, and out-of-home placement. Anecdotal evidence and community samples already suggest that a disproportionately higher number of sexual-minority youth enter foster care, he said, possibly resulting in part from family conflict about sexual orientation. In addition, LGBTQ+ youth already experience higher rates of psychological and physical abuse at home – a top reason for entry into child welfare – and this population has high rates of running away, particularly around the time of coming out.

Past research has found that sexual-minority youth experience higher rates of maltreatment and discrimination than do their peers from foster parents, siblings, and agency staff, which translates to fewer support services and lower levels of reunification or adoption.

In the National Longitudinal Study of Adolescent to Adult Health involving 14,154 respondents, 6.3% reported any same-sex attraction, and 2.1% were involved in the foster-care system. The researchers determined that 4.3% of sexual-minority youth were involved in foster care, compared with just 1.9% of heterosexual youth (P = .002) – a 2.5 times greater rate – with a stronger effect among those with exclusively same-sex attraction.

In the second part of the study, the researchers looked at 1,014 youths in the foster-care system, of whom 80% had experienced an out-of-home placement. The 16% of youth in foster care reporting same sex attraction did not have a higher rate of out-of-home placement than did heterosexual youth within the system. However, there were twice as many sexual-minority youth in child welfare and four times as many in out-of-home placement, compared with their heterosexual peers, possibly suggesting that sexual-minority youth are less likely to exit the system, Dr. Rafferty said.

“Many studies have shown that family acceptance is a critical factor in building resiliency, while rejection is tied to poor physical and emotional outcomes,” he said. “It would follow that we’re identifying a critical at-risk group of sexual-minority youth lacking in fundamental and essential family support.”

This population “experiences the intersection of multiple forces of marginalization, including out-of-home placement, socioeconomic stress, sexual minority status, and likely, race,” Dr. Rafferty said.

Ms. Kronk commented during the session that fertility services and collection are extremely expensive, often forcing trans people into the absurd situation of having to choose between paying for hormone therapy or paying for fertility treatment.

“This makes a really strong argument for resource allocation based on risk” and has ramifications for the higher proportions of sexual-minority youth facing transition without adequate support services, Dr. Rafferty said.

It also suggests the need for providers to help patients feel comfortable and safe talking about their needs, Ms. Kronk said.

“Unfortunately, LGBTQIA+ health care is not taught very comprehensively in the United States [and most other countries],” she said. “Oftentimes, this leads to awkward situations where patients are more knowledgeable than their providers. Listening, learning, supporting, and being open to change are what every provider should take to heart.”

Dr. Rafferty and Ms. Kronk had no relevant financial disclosures.

Caring for LGBTQ+ pediatric patients often requires physicians to consider issues – such as preservation of fertility for transgender youth and resource allocation to sexual-minority youth in the foster-care system – that they may not think about as frequently with their other patients.

monkeybusinessimages/Getty Images

“It’s important to engage transgender and gender-diverse youth and families in fertility counseling early in their gender affirmation process,” but it does not happen as often as it should, said Jason Rafferty, MD (he/him/his), a clinical assistant professor of psychiatry and human behavior at the Warren Alpert Medical School of Brown University, Providence, R.I. Dr. Rafferty discussed two studies at the annual meeting of the American Academy of Pediatrics, held virtually this year: one on fertility outcomes among a small transgender sample and another finding that sexual-minority youth are 2.5 times more likely to be involved in the foster-care system.

“We need to recognize and address disparities in health that place sexual-minority youth at increased risk for child welfare involvement,” he told attendees.
 

Fertility preservation and counseling for transgender patients

Evidence suggests gender-affirming hormone treatment affects gonadal structures and functions in ways that may decrease fertility potential, Dr. Rafferty said. “Yet, there’s very little [research] into the reversibility or thresholds above which fertility potential is affected.”

The World Professional Association for Transgender Health (WPATH) recommends that doctors discuss the possible adverse health effects of feminizing or masculinizing treatments and the patient’s reproductive options before starting hormone therapy, although the extent to which this therapy may impair fertility isn’t known.

The first study Dr. Rafferty discussed was an assessment of semen cryopreservation outcomes among youth asserting a female identity. The researchers conducted a retrospective chart review on a convenience sample of 11 transgender and gender-diverse adolescents and young adults who had been referred for fertility preservation between January 2015 and September 2018 at the University of Pittsburgh Medical Center Children’s Hospital and the UPMC Magee-Womens Hospital in Pittsburgh.

Of the 11, 1 did not provide a sample, and another discarded their sample after 4 months. The seven patients without prior gender-affirming hormone treatment (average age 19 at time of fertility consultation) were all able to produce a semen sample, which showed normal parameters, except for some abnormal morphology. The significance of that one abnormal finding was unclear without a control group, Dr. Rafferty said. All seven began gonadotropin-releasing hormone (GnRH) agonist therapy, and four also began estradiol therapy, although Dr. Rafferty questioned why GnRH agonist therapy was started at such late ages.

Regardless, he said, the takeaway from this first group was the efficiency and effectiveness of getting a semen sample before beginning gender-affirming hormone therapy. The second group offered a different takeaway.

“What I think is probably the most unique aspect of this study is this second group of two individuals who had previously received hormones or blockers,” Dr. Rafferty told attendees. The first patient was 13 years of age at gender dysphoria onset and 18 years at the time of their fertility consultation. They had been on GnRH agonists for 6 months before semen collection. Their first sample, at 3 months after discontinuing hormones, was low-quality, but they did produce a viable sample 2 months later.

The other patient, who underwent fertility consultation at age 19, had taken estrogen and spironolactone for 26 months before semen collection and were not able to produce sperm 4 months after stopping the treatment. They did not try again because they underwent an orchiectomy.

Despite the small sample size and lack of confounding data, such as smoking and stress, the study remains the first to show successful sampling after gender-affirming hormone therapy in a teen, Dr. Rafferty said. It also shows that sampling after beginning hormone therapy may require discontinuation for several months before a successful sample is possible, thereby supporting WPATH’s recommendation for early fertility counseling.

“However, the standard of providing fertility counseling before intervention does not always occur,” Dr. Rafferty said, citing research that found low percentages of teens had received fertility counseling or discussed negative effects of therapy on fertility prior to starting it. These low numbers may result from changes in youths’ interest in fertility throughout development, but they could also relate to youths’ reluctance to discuss family planning while they feel uncomfortable in their bodies.

“My experience, and there is some empirical evidence for this, is that many transgender and gender-diverse youth feel more comfortable conceptualizing and pursuing intimate partner relationships and family planning after they start gender affirmation interventions,” Dr. Rafferty said. The stress associated with gender dysphoria can further complicate fertility discussions, and providers have to consider whether it’s more stressful to hold off on gender-affirming hormone therapy until the patient gets a successful semen sample or to start therapy and then discontinue for several months to get a sample later.

While decisions about fertility services should be fully up to the patient, in reality, multiple barriers – such as high cost, low insurance coverage, a dearth of specialists who can do the procedures, and inaccurate assumptions about transgender people’s interest in family planning – complicate the decision,.

“Systemically denying a marginalized population the ability to reproduce, or at least the ability to make a free choice about reproduction and family planning, is a reproductive justice issue that’s not getting the attention it deserves,” Dr. Rafferty said.

Clair Kronk, BSc, a session attendee from the University of Cincinnati College of Medicine and Cincinnati Children’s Hospital and Medical Center, said in an interview that she appreciated the session even while she lamented the lack of adequate evidence on transgender and gender-diverse care.

“I do feel like there are a lot of provider-based questions with no sufficient guidelines right now when it comes to transgender care,” Ms. Kronk said. “Despite being nearly a century old, treatment of trans patients is somehow still a ‘Wild West’ of medical care, which is sad to see.” She is grateful to see attention finally reaching this population.

“It is imperative that medical institutions focus on real, advanceable diversity, equity, and inclusion initiatives which center marginalized groups,” she said. “Centering minoritized and marginalized peoples in improving care is the only way lasting change will happen.”
 

Sexual-minority youth in foster care

The second study Dr. Rafferty discussed was the first nationally representative systemic assessment of the prevalence of sexual-minority youth in foster care, child welfare, and out-of-home placement. Anecdotal evidence and community samples already suggest that a disproportionately higher number of sexual-minority youth enter foster care, he said, possibly resulting in part from family conflict about sexual orientation. In addition, LGBTQ+ youth already experience higher rates of psychological and physical abuse at home – a top reason for entry into child welfare – and this population has high rates of running away, particularly around the time of coming out.

Past research has found that sexual-minority youth experience higher rates of maltreatment and discrimination than do their peers from foster parents, siblings, and agency staff, which translates to fewer support services and lower levels of reunification or adoption.

In the National Longitudinal Study of Adolescent to Adult Health involving 14,154 respondents, 6.3% reported any same-sex attraction, and 2.1% were involved in the foster-care system. The researchers determined that 4.3% of sexual-minority youth were involved in foster care, compared with just 1.9% of heterosexual youth (P = .002) – a 2.5 times greater rate – with a stronger effect among those with exclusively same-sex attraction.

In the second part of the study, the researchers looked at 1,014 youths in the foster-care system, of whom 80% had experienced an out-of-home placement. The 16% of youth in foster care reporting same sex attraction did not have a higher rate of out-of-home placement than did heterosexual youth within the system. However, there were twice as many sexual-minority youth in child welfare and four times as many in out-of-home placement, compared with their heterosexual peers, possibly suggesting that sexual-minority youth are less likely to exit the system, Dr. Rafferty said.

“Many studies have shown that family acceptance is a critical factor in building resiliency, while rejection is tied to poor physical and emotional outcomes,” he said. “It would follow that we’re identifying a critical at-risk group of sexual-minority youth lacking in fundamental and essential family support.”

This population “experiences the intersection of multiple forces of marginalization, including out-of-home placement, socioeconomic stress, sexual minority status, and likely, race,” Dr. Rafferty said.

Ms. Kronk commented during the session that fertility services and collection are extremely expensive, often forcing trans people into the absurd situation of having to choose between paying for hormone therapy or paying for fertility treatment.

“This makes a really strong argument for resource allocation based on risk” and has ramifications for the higher proportions of sexual-minority youth facing transition without adequate support services, Dr. Rafferty said.

It also suggests the need for providers to help patients feel comfortable and safe talking about their needs, Ms. Kronk said.

“Unfortunately, LGBTQIA+ health care is not taught very comprehensively in the United States [and most other countries],” she said. “Oftentimes, this leads to awkward situations where patients are more knowledgeable than their providers. Listening, learning, supporting, and being open to change are what every provider should take to heart.”

Dr. Rafferty and Ms. Kronk had no relevant financial disclosures.

Caring for LGBTQ+ pediatric patients often requires physicians to consider issues – such as preservation of fertility for transgender youth and resource allocation to sexual-minority youth in the foster-care system – that they may not think about as frequently with their other patients.

monkeybusinessimages/Getty Images

“It’s important to engage transgender and gender-diverse youth and families in fertility counseling early in their gender affirmation process,” but it does not happen as often as it should, said Jason Rafferty, MD (he/him/his), a clinical assistant professor of psychiatry and human behavior at the Warren Alpert Medical School of Brown University, Providence, R.I. Dr. Rafferty discussed two studies at the annual meeting of the American Academy of Pediatrics, held virtually this year: one on fertility outcomes among a small transgender sample and another finding that sexual-minority youth are 2.5 times more likely to be involved in the foster-care system.

“We need to recognize and address disparities in health that place sexual-minority youth at increased risk for child welfare involvement,” he told attendees.
 

Fertility preservation and counseling for transgender patients

Evidence suggests gender-affirming hormone treatment affects gonadal structures and functions in ways that may decrease fertility potential, Dr. Rafferty said. “Yet, there’s very little [research] into the reversibility or thresholds above which fertility potential is affected.”

The World Professional Association for Transgender Health (WPATH) recommends that doctors discuss the possible adverse health effects of feminizing or masculinizing treatments and the patient’s reproductive options before starting hormone therapy, although the extent to which this therapy may impair fertility isn’t known.

The first study Dr. Rafferty discussed was an assessment of semen cryopreservation outcomes among youth asserting a female identity. The researchers conducted a retrospective chart review on a convenience sample of 11 transgender and gender-diverse adolescents and young adults who had been referred for fertility preservation between January 2015 and September 2018 at the University of Pittsburgh Medical Center Children’s Hospital and the UPMC Magee-Womens Hospital in Pittsburgh.

Of the 11, 1 did not provide a sample, and another discarded their sample after 4 months. The seven patients without prior gender-affirming hormone treatment (average age 19 at time of fertility consultation) were all able to produce a semen sample, which showed normal parameters, except for some abnormal morphology. The significance of that one abnormal finding was unclear without a control group, Dr. Rafferty said. All seven began gonadotropin-releasing hormone (GnRH) agonist therapy, and four also began estradiol therapy, although Dr. Rafferty questioned why GnRH agonist therapy was started at such late ages.

Regardless, he said, the takeaway from this first group was the efficiency and effectiveness of getting a semen sample before beginning gender-affirming hormone therapy. The second group offered a different takeaway.

“What I think is probably the most unique aspect of this study is this second group of two individuals who had previously received hormones or blockers,” Dr. Rafferty told attendees. The first patient was 13 years of age at gender dysphoria onset and 18 years at the time of their fertility consultation. They had been on GnRH agonists for 6 months before semen collection. Their first sample, at 3 months after discontinuing hormones, was low-quality, but they did produce a viable sample 2 months later.

The other patient, who underwent fertility consultation at age 19, had taken estrogen and spironolactone for 26 months before semen collection and were not able to produce sperm 4 months after stopping the treatment. They did not try again because they underwent an orchiectomy.

Despite the small sample size and lack of confounding data, such as smoking and stress, the study remains the first to show successful sampling after gender-affirming hormone therapy in a teen, Dr. Rafferty said. It also shows that sampling after beginning hormone therapy may require discontinuation for several months before a successful sample is possible, thereby supporting WPATH’s recommendation for early fertility counseling.

“However, the standard of providing fertility counseling before intervention does not always occur,” Dr. Rafferty said, citing research that found low percentages of teens had received fertility counseling or discussed negative effects of therapy on fertility prior to starting it. These low numbers may result from changes in youths’ interest in fertility throughout development, but they could also relate to youths’ reluctance to discuss family planning while they feel uncomfortable in their bodies.

“My experience, and there is some empirical evidence for this, is that many transgender and gender-diverse youth feel more comfortable conceptualizing and pursuing intimate partner relationships and family planning after they start gender affirmation interventions,” Dr. Rafferty said. The stress associated with gender dysphoria can further complicate fertility discussions, and providers have to consider whether it’s more stressful to hold off on gender-affirming hormone therapy until the patient gets a successful semen sample or to start therapy and then discontinue for several months to get a sample later.

While decisions about fertility services should be fully up to the patient, in reality, multiple barriers – such as high cost, low insurance coverage, a dearth of specialists who can do the procedures, and inaccurate assumptions about transgender people’s interest in family planning – complicate the decision,.

“Systemically denying a marginalized population the ability to reproduce, or at least the ability to make a free choice about reproduction and family planning, is a reproductive justice issue that’s not getting the attention it deserves,” Dr. Rafferty said.

Clair Kronk, BSc, a session attendee from the University of Cincinnati College of Medicine and Cincinnati Children’s Hospital and Medical Center, said in an interview that she appreciated the session even while she lamented the lack of adequate evidence on transgender and gender-diverse care.

“I do feel like there are a lot of provider-based questions with no sufficient guidelines right now when it comes to transgender care,” Ms. Kronk said. “Despite being nearly a century old, treatment of trans patients is somehow still a ‘Wild West’ of medical care, which is sad to see.” She is grateful to see attention finally reaching this population.

“It is imperative that medical institutions focus on real, advanceable diversity, equity, and inclusion initiatives which center marginalized groups,” she said. “Centering minoritized and marginalized peoples in improving care is the only way lasting change will happen.”
 

Sexual-minority youth in foster care

The second study Dr. Rafferty discussed was the first nationally representative systemic assessment of the prevalence of sexual-minority youth in foster care, child welfare, and out-of-home placement. Anecdotal evidence and community samples already suggest that a disproportionately higher number of sexual-minority youth enter foster care, he said, possibly resulting in part from family conflict about sexual orientation. In addition, LGBTQ+ youth already experience higher rates of psychological and physical abuse at home – a top reason for entry into child welfare – and this population has high rates of running away, particularly around the time of coming out.

Past research has found that sexual-minority youth experience higher rates of maltreatment and discrimination than do their peers from foster parents, siblings, and agency staff, which translates to fewer support services and lower levels of reunification or adoption.

In the National Longitudinal Study of Adolescent to Adult Health involving 14,154 respondents, 6.3% reported any same-sex attraction, and 2.1% were involved in the foster-care system. The researchers determined that 4.3% of sexual-minority youth were involved in foster care, compared with just 1.9% of heterosexual youth (P = .002) – a 2.5 times greater rate – with a stronger effect among those with exclusively same-sex attraction.

In the second part of the study, the researchers looked at 1,014 youths in the foster-care system, of whom 80% had experienced an out-of-home placement. The 16% of youth in foster care reporting same sex attraction did not have a higher rate of out-of-home placement than did heterosexual youth within the system. However, there were twice as many sexual-minority youth in child welfare and four times as many in out-of-home placement, compared with their heterosexual peers, possibly suggesting that sexual-minority youth are less likely to exit the system, Dr. Rafferty said.

“Many studies have shown that family acceptance is a critical factor in building resiliency, while rejection is tied to poor physical and emotional outcomes,” he said. “It would follow that we’re identifying a critical at-risk group of sexual-minority youth lacking in fundamental and essential family support.”

This population “experiences the intersection of multiple forces of marginalization, including out-of-home placement, socioeconomic stress, sexual minority status, and likely, race,” Dr. Rafferty said.

Ms. Kronk commented during the session that fertility services and collection are extremely expensive, often forcing trans people into the absurd situation of having to choose between paying for hormone therapy or paying for fertility treatment.

“This makes a really strong argument for resource allocation based on risk” and has ramifications for the higher proportions of sexual-minority youth facing transition without adequate support services, Dr. Rafferty said.

It also suggests the need for providers to help patients feel comfortable and safe talking about their needs, Ms. Kronk said.

“Unfortunately, LGBTQIA+ health care is not taught very comprehensively in the United States [and most other countries],” she said. “Oftentimes, this leads to awkward situations where patients are more knowledgeable than their providers. Listening, learning, supporting, and being open to change are what every provider should take to heart.”

Dr. Rafferty and Ms. Kronk had no relevant financial disclosures.

Although there is an effective vaccine against Bordetella pertussis, whooping cough remains a leading cause of death. Cases are increasing, and scientists face challenges in developing new vaccines.

copyright Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

In a key research session at the start of the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year, Dimitri Diavatopoulos, PhD, associate professor at the Radboud University Medical Centre Nijmegen, the Netherlands, summarized the pertussis vaccination problem and what the Pertussis Correlates of Protection Europe (PERISCOPE) project seeks to achieve. Dr. Diavatopoulos has a longstanding interest in pertussis and immunity and will soon take over as the scientific coordinator of PERISCOPE.

Pertussis is a highly contagious infectious disease that causes uncontrollable coughing. The disease begins with an atypical cough and rhinorrhea before entering a paroxysmal stage characterized by cyanosis, lymphocytosis, vomiting, and whoops. Generally, fever is absent and coughing increases at night. Finally, after weeks to months, the patient enters a convalescent stage. The World Health Organization estimates that there are 16 million pertussis cases annually and approximately 195,000 deaths in children. Most cases are caused by Bordetella pertussis and are preventable by vaccination.

In the United States, following the introduction of a national immunization program using a whole-cell vaccine in the 1950s, cases fell significantly. After a lag phase, the adoption of an acellular vaccine in the United States in 1997 and the Netherlands in 2005 – usually in combination with diphtheria and tetanus via DTaP – saw an increase in case numbers. Dr. Diavatopoulos stated that control is no longer as good, compared with other infectious diseases prevented by the MMR vaccine, such as mumps, measles, and rubella.

In the face of increasing numbers, how do we move to the next generation of vaccines to improve control? There are several barriers to licensure, including the following:

• Universal recommendation for pertussis prevention means that more than 90% of the population will have received DTaP (usually in combination with polio and Haemophilus influenzae B) and be protected for several years after vaccination.

• Because DTaP vaccines are only efficacious for a limited time, the problem is not immediately apparent.

• Pertussis epidemics are cyclical, occurring every 3-5 years. These peaks and troughs complicate the development of epidemiological studies.

What this means is that large-scale Phase III efficacy studies, in which disease is used as the endpoint, are not feasible. Also, formal correlates of protection have not been identified.

The PERISCOPE Project started in March 2016 and is designed to respond to some of these issues. Funding is made available by a public private consortium involving the Bill & Melinda Gates foundation, the European Union, and European Federation of Pharmaceutical Industries and Associations (EFPIA) partners, and in this case, GlaxoSmithKline and Sanofi Pasteur. In total, there are 22 partners in this project.

The strategic objectives of this partnership include the following:

• Foster expertise and increase capacity in Europe to evaluate new pertussis vaccines both in clinical and preclinical models.

• Identify early biomarkers of long-lasting protective immunity to pertussis in humans. (This step will accelerate and de-risk clinical development of next generation pertussis vaccines.)

• Investigate the impact of maternal vaccination on infant response to pertussis vaccination.

The problem is that there is no one single study design that addresses all questions about the pertussis vaccine. For example, in PERISCOPE, the results of preclinical studies using the baboon or mouse models and addressing disease and colonization endpoints or immunogenicity do not perfectly model human infection and disease.

By comparison, controlled human infection studies provide information on colonization but not disease endpoints. Such studies, however, do provide information on immunogenicity endpoints. Also available are booster vaccination studies and infant vaccination studies providing data on immunogenicity, as well as safety information.

Finally, there are patient studies, such as household contact studies where immunogenicity can be correlated to disease endpoints. From these studies, it will be seen that what is needed is integration of evidence from clinical and preclinical studies to support a new vaccine registration.

PERISCOPE addresses these issues by developing novel, functional antibody and cellular assays and employing cutting-edge methods to characterize innate immune responses and cell-mediated systemic and mucosal immunity. PERISCOPE combines two major industrial partners with public researchers from academic and public health institutes and small and medium-sized enterprises with expertise in clinical trials, vaccinology, immunology, molecular microbiology, challenge models, and bioinformatics.

Andrew Gorringe, PhD, from Public Health England and the Research and Development Institute at Porton Down, Wiltshire, England, said, “Vaccines have greatly reduced the incidence of pertussis, but it remains the most prevalent ‘vaccine preventable’ disease. This is an exciting period for pertussis vaccine research as we find new ways to understand the immunity that protects from both infection and disease. The PERISCOPE project provides a collaborative environment that combines expertise across Europe to provide a route to the development of new, more effective vaccines.”

GSK and Sanofi Pasteur have cofunded the PERISCOPE Project. Dr. Diavatopoulos made no other financial disclosures.

Although there is an effective vaccine against Bordetella pertussis, whooping cough remains a leading cause of death. Cases are increasing, and scientists face challenges in developing new vaccines.

copyright Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

In a key research session at the start of the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year, Dimitri Diavatopoulos, PhD, associate professor at the Radboud University Medical Centre Nijmegen, the Netherlands, summarized the pertussis vaccination problem and what the Pertussis Correlates of Protection Europe (PERISCOPE) project seeks to achieve. Dr. Diavatopoulos has a longstanding interest in pertussis and immunity and will soon take over as the scientific coordinator of PERISCOPE.

Pertussis is a highly contagious infectious disease that causes uncontrollable coughing. The disease begins with an atypical cough and rhinorrhea before entering a paroxysmal stage characterized by cyanosis, lymphocytosis, vomiting, and whoops. Generally, fever is absent and coughing increases at night. Finally, after weeks to months, the patient enters a convalescent stage. The World Health Organization estimates that there are 16 million pertussis cases annually and approximately 195,000 deaths in children. Most cases are caused by Bordetella pertussis and are preventable by vaccination.

In the United States, following the introduction of a national immunization program using a whole-cell vaccine in the 1950s, cases fell significantly. After a lag phase, the adoption of an acellular vaccine in the United States in 1997 and the Netherlands in 2005 – usually in combination with diphtheria and tetanus via DTaP – saw an increase in case numbers. Dr. Diavatopoulos stated that control is no longer as good, compared with other infectious diseases prevented by the MMR vaccine, such as mumps, measles, and rubella.

In the face of increasing numbers, how do we move to the next generation of vaccines to improve control? There are several barriers to licensure, including the following:

• Universal recommendation for pertussis prevention means that more than 90% of the population will have received DTaP (usually in combination with polio and Haemophilus influenzae B) and be protected for several years after vaccination.

• Because DTaP vaccines are only efficacious for a limited time, the problem is not immediately apparent.

• Pertussis epidemics are cyclical, occurring every 3-5 years. These peaks and troughs complicate the development of epidemiological studies.

What this means is that large-scale Phase III efficacy studies, in which disease is used as the endpoint, are not feasible. Also, formal correlates of protection have not been identified.

The PERISCOPE Project started in March 2016 and is designed to respond to some of these issues. Funding is made available by a public private consortium involving the Bill & Melinda Gates foundation, the European Union, and European Federation of Pharmaceutical Industries and Associations (EFPIA) partners, and in this case, GlaxoSmithKline and Sanofi Pasteur. In total, there are 22 partners in this project.

The strategic objectives of this partnership include the following:

• Foster expertise and increase capacity in Europe to evaluate new pertussis vaccines both in clinical and preclinical models.

• Identify early biomarkers of long-lasting protective immunity to pertussis in humans. (This step will accelerate and de-risk clinical development of next generation pertussis vaccines.)

• Investigate the impact of maternal vaccination on infant response to pertussis vaccination.

The problem is that there is no one single study design that addresses all questions about the pertussis vaccine. For example, in PERISCOPE, the results of preclinical studies using the baboon or mouse models and addressing disease and colonization endpoints or immunogenicity do not perfectly model human infection and disease.

By comparison, controlled human infection studies provide information on colonization but not disease endpoints. Such studies, however, do provide information on immunogenicity endpoints. Also available are booster vaccination studies and infant vaccination studies providing data on immunogenicity, as well as safety information.

Finally, there are patient studies, such as household contact studies where immunogenicity can be correlated to disease endpoints. From these studies, it will be seen that what is needed is integration of evidence from clinical and preclinical studies to support a new vaccine registration.

PERISCOPE addresses these issues by developing novel, functional antibody and cellular assays and employing cutting-edge methods to characterize innate immune responses and cell-mediated systemic and mucosal immunity. PERISCOPE combines two major industrial partners with public researchers from academic and public health institutes and small and medium-sized enterprises with expertise in clinical trials, vaccinology, immunology, molecular microbiology, challenge models, and bioinformatics.

Andrew Gorringe, PhD, from Public Health England and the Research and Development Institute at Porton Down, Wiltshire, England, said, “Vaccines have greatly reduced the incidence of pertussis, but it remains the most prevalent ‘vaccine preventable’ disease. This is an exciting period for pertussis vaccine research as we find new ways to understand the immunity that protects from both infection and disease. The PERISCOPE project provides a collaborative environment that combines expertise across Europe to provide a route to the development of new, more effective vaccines.”

GSK and Sanofi Pasteur have cofunded the PERISCOPE Project. Dr. Diavatopoulos made no other financial disclosures.

Although there is an effective vaccine against Bordetella pertussis, whooping cough remains a leading cause of death. Cases are increasing, and scientists face challenges in developing new vaccines.

copyright Jacopo Werther/Wikimedia Commons/Creative Commons Attribution 2.0

In a key research session at the start of the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year, Dimitri Diavatopoulos, PhD, associate professor at the Radboud University Medical Centre Nijmegen, the Netherlands, summarized the pertussis vaccination problem and what the Pertussis Correlates of Protection Europe (PERISCOPE) project seeks to achieve. Dr. Diavatopoulos has a longstanding interest in pertussis and immunity and will soon take over as the scientific coordinator of PERISCOPE.

Pertussis is a highly contagious infectious disease that causes uncontrollable coughing. The disease begins with an atypical cough and rhinorrhea before entering a paroxysmal stage characterized by cyanosis, lymphocytosis, vomiting, and whoops. Generally, fever is absent and coughing increases at night. Finally, after weeks to months, the patient enters a convalescent stage. The World Health Organization estimates that there are 16 million pertussis cases annually and approximately 195,000 deaths in children. Most cases are caused by Bordetella pertussis and are preventable by vaccination.

In the United States, following the introduction of a national immunization program using a whole-cell vaccine in the 1950s, cases fell significantly. After a lag phase, the adoption of an acellular vaccine in the United States in 1997 and the Netherlands in 2005 – usually in combination with diphtheria and tetanus via DTaP – saw an increase in case numbers. Dr. Diavatopoulos stated that control is no longer as good, compared with other infectious diseases prevented by the MMR vaccine, such as mumps, measles, and rubella.

In the face of increasing numbers, how do we move to the next generation of vaccines to improve control? There are several barriers to licensure, including the following:

• Universal recommendation for pertussis prevention means that more than 90% of the population will have received DTaP (usually in combination with polio and Haemophilus influenzae B) and be protected for several years after vaccination.

• Because DTaP vaccines are only efficacious for a limited time, the problem is not immediately apparent.

• Pertussis epidemics are cyclical, occurring every 3-5 years. These peaks and troughs complicate the development of epidemiological studies.

What this means is that large-scale Phase III efficacy studies, in which disease is used as the endpoint, are not feasible. Also, formal correlates of protection have not been identified.

The PERISCOPE Project started in March 2016 and is designed to respond to some of these issues. Funding is made available by a public private consortium involving the Bill & Melinda Gates foundation, the European Union, and European Federation of Pharmaceutical Industries and Associations (EFPIA) partners, and in this case, GlaxoSmithKline and Sanofi Pasteur. In total, there are 22 partners in this project.

The strategic objectives of this partnership include the following:

• Foster expertise and increase capacity in Europe to evaluate new pertussis vaccines both in clinical and preclinical models.

• Identify early biomarkers of long-lasting protective immunity to pertussis in humans. (This step will accelerate and de-risk clinical development of next generation pertussis vaccines.)

• Investigate the impact of maternal vaccination on infant response to pertussis vaccination.

The problem is that there is no one single study design that addresses all questions about the pertussis vaccine. For example, in PERISCOPE, the results of preclinical studies using the baboon or mouse models and addressing disease and colonization endpoints or immunogenicity do not perfectly model human infection and disease.

By comparison, controlled human infection studies provide information on colonization but not disease endpoints. Such studies, however, do provide information on immunogenicity endpoints. Also available are booster vaccination studies and infant vaccination studies providing data on immunogenicity, as well as safety information.

Finally, there are patient studies, such as household contact studies where immunogenicity can be correlated to disease endpoints. From these studies, it will be seen that what is needed is integration of evidence from clinical and preclinical studies to support a new vaccine registration.

PERISCOPE addresses these issues by developing novel, functional antibody and cellular assays and employing cutting-edge methods to characterize innate immune responses and cell-mediated systemic and mucosal immunity. PERISCOPE combines two major industrial partners with public researchers from academic and public health institutes and small and medium-sized enterprises with expertise in clinical trials, vaccinology, immunology, molecular microbiology, challenge models, and bioinformatics.

Andrew Gorringe, PhD, from Public Health England and the Research and Development Institute at Porton Down, Wiltshire, England, said, “Vaccines have greatly reduced the incidence of pertussis, but it remains the most prevalent ‘vaccine preventable’ disease. This is an exciting period for pertussis vaccine research as we find new ways to understand the immunity that protects from both infection and disease. The PERISCOPE project provides a collaborative environment that combines expertise across Europe to provide a route to the development of new, more effective vaccines.”

GSK and Sanofi Pasteur have cofunded the PERISCOPE Project. Dr. Diavatopoulos made no other financial disclosures.

Emergency department visits related to child abuse and neglect dropped by half early in the pandemic, compared with 2019, but the visits in 2020 were significantly more likely to result in hospitalization, based on analysis of a national ED database.

The number of ED visits involving child abuse and neglect was down by 53% during the 4-week period from March 29 to April 25, 2020, compared with the 4 weeks from March 31 to April 27, 2019. The proportion of those ED visits that ended in hospitalizations, however, increased from 2.1% in 2019 to 3.2% in 2020, Elizabeth Swedo, MD, and associates at the Centers for Disease Control and Prevention said in the Morbidity and Mortality Weekly Report.

“ED visits related to suspected or confirmed child abuse and neglect decreased beginning the week of March 15, 2020, coinciding with the declaration of a national emergency related to COVID-19 and implementation of community mitigation measures,” they wrote.

An earlier study involving the same database (the National Syndromic Surveillance Program) showed that, over the two same 4-week periods, the volume of all ED visits in 2020 was down 72% for children aged 10 years and younger and 71% for those aged 11-14 years.

In the current study, however, all age subgroups had significant increases in hospital admissions. The proportion of ED visits related to child abuse and neglect that resulted in hospitalization rose from 3.5% in 2019 to 5.3% in 2020 among ages 0-4 years, 0.7% to 1.3% for ages 5-11 years, and 1.6% to 2.2% for adolescents aged 12-17, Dr. Swedo and associates reported.

The absence of a corresponding drop in hospitalizations may be tied to risk factors related to the pandemic, “such as loss of income, increased stress related to parental child care and schooling responsibilities, and increased substance use and mental health conditions among adults,” the investigators added.

The National Syndromic Surveillance Program receives daily data from 3,310 EDs in 47 states, but the number of facilities meeting the investigators’ criteria averaged 2,970 a week for the 8 weeks of the study period.

[email protected]

SOURCE: Swedo E et al. MMWR. 2020 Dec. 11;69(49):1841-7.

Emergency department visits related to child abuse and neglect dropped by half early in the pandemic, compared with 2019, but the visits in 2020 were significantly more likely to result in hospitalization, based on analysis of a national ED database.

The number of ED visits involving child abuse and neglect was down by 53% during the 4-week period from March 29 to April 25, 2020, compared with the 4 weeks from March 31 to April 27, 2019. The proportion of those ED visits that ended in hospitalizations, however, increased from 2.1% in 2019 to 3.2% in 2020, Elizabeth Swedo, MD, and associates at the Centers for Disease Control and Prevention said in the Morbidity and Mortality Weekly Report.

“ED visits related to suspected or confirmed child abuse and neglect decreased beginning the week of March 15, 2020, coinciding with the declaration of a national emergency related to COVID-19 and implementation of community mitigation measures,” they wrote.

An earlier study involving the same database (the National Syndromic Surveillance Program) showed that, over the two same 4-week periods, the volume of all ED visits in 2020 was down 72% for children aged 10 years and younger and 71% for those aged 11-14 years.

In the current study, however, all age subgroups had significant increases in hospital admissions. The proportion of ED visits related to child abuse and neglect that resulted in hospitalization rose from 3.5% in 2019 to 5.3% in 2020 among ages 0-4 years, 0.7% to 1.3% for ages 5-11 years, and 1.6% to 2.2% for adolescents aged 12-17, Dr. Swedo and associates reported.

The absence of a corresponding drop in hospitalizations may be tied to risk factors related to the pandemic, “such as loss of income, increased stress related to parental child care and schooling responsibilities, and increased substance use and mental health conditions among adults,” the investigators added.

The National Syndromic Surveillance Program receives daily data from 3,310 EDs in 47 states, but the number of facilities meeting the investigators’ criteria averaged 2,970 a week for the 8 weeks of the study period.

[email protected]

SOURCE: Swedo E et al. MMWR. 2020 Dec. 11;69(49):1841-7.

Emergency department visits related to child abuse and neglect dropped by half early in the pandemic, compared with 2019, but the visits in 2020 were significantly more likely to result in hospitalization, based on analysis of a national ED database.

The number of ED visits involving child abuse and neglect was down by 53% during the 4-week period from March 29 to April 25, 2020, compared with the 4 weeks from March 31 to April 27, 2019. The proportion of those ED visits that ended in hospitalizations, however, increased from 2.1% in 2019 to 3.2% in 2020, Elizabeth Swedo, MD, and associates at the Centers for Disease Control and Prevention said in the Morbidity and Mortality Weekly Report.

“ED visits related to suspected or confirmed child abuse and neglect decreased beginning the week of March 15, 2020, coinciding with the declaration of a national emergency related to COVID-19 and implementation of community mitigation measures,” they wrote.

An earlier study involving the same database (the National Syndromic Surveillance Program) showed that, over the two same 4-week periods, the volume of all ED visits in 2020 was down 72% for children aged 10 years and younger and 71% for those aged 11-14 years.

In the current study, however, all age subgroups had significant increases in hospital admissions. The proportion of ED visits related to child abuse and neglect that resulted in hospitalization rose from 3.5% in 2019 to 5.3% in 2020 among ages 0-4 years, 0.7% to 1.3% for ages 5-11 years, and 1.6% to 2.2% for adolescents aged 12-17, Dr. Swedo and associates reported.

The absence of a corresponding drop in hospitalizations may be tied to risk factors related to the pandemic, “such as loss of income, increased stress related to parental child care and schooling responsibilities, and increased substance use and mental health conditions among adults,” the investigators added.

The National Syndromic Surveillance Program receives daily data from 3,310 EDs in 47 states, but the number of facilities meeting the investigators’ criteria averaged 2,970 a week for the 8 weeks of the study period.

[email protected]

SOURCE: Swedo E et al. MMWR. 2020 Dec. 11;69(49):1841-7.

With increasing whooping cough numbers, developing an effective new vaccine against Bordetella pertussis is a priority. Results from the multifactorial PERISCOPE Project will help scientists and clinicians move forward.

MarianVejcik/Getty Images

Dominic Kelly, PhD, talked about vaccine-induced immunity and provided an overview of ongoing clinical trials in the PERISCOPE (Pertussis Correlates of Protection Europe) project in a key research session at the start of the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. Dr. Kelly, a pediatrician at the Children’s Hospital in Oxford and a member of the Oxford Vaccines Group, leads one of the studies in the project looking at infant vaccination.

Dr. Kelly began his presentation by showing a figure depicting where vaccine-induced immunity fits into the larger suite of clinical studies. These studies involve mouse models, human challenge models, and infection patients. A key theme is the use of a core group of immunoassays across all studies, with the hope that they will allow effective cross comparisons.

Dr. Kelly stated, “If we find a correlate of protection in the challenge model, we can then interpret the vaccine studies in the light of that because we are using standardized constant immunoassays.”

The assays being used depend in part on the specific study and the volume of blood available. They will generally include Bordetella-specific antibody and functional antibody assays, as well as interesting studies collecting mucosal samples from infants and adults to look at serological responses. Also under examination are a range of enzyme-linked immune absorbent spot, flow cytometry, and culture techniques looking at Memory B cells, T cells, and gene expression.

Complementing these assay studies, PERISCOPE includes a series of clinical investigations designed to throw light on three areas of interest, described below:

First, researchers hope to gain a better understanding regarding the effects of the original whole cell vaccine versus the current acellular variety. The former uses an inactivated version of the whole organism. Epidemiological studies, animal data, and experience in the field demonstrate that whole-cell vaccination results in a broad, long-lasting, and effective immune response.

By comparison, the acellular pertussis vaccine consists of between three and five protein components, which are purified from cultured Bordetella pertussis. While it is an effective vaccine, its effects are less durable; routine use in some countries is associated with cyclical outbreaks of increasing severity.

A second issue for researchers involved in the PERISCOPE project concerns the effects of maternal immunization. In the United Kingdom in 2012, for example, an increasing number of cases were noted 6-7 years after adoption of an acellular vaccine for routine vaccination in the 2nd-3rd trimester of pregnancy. Vaccination appears to effectively control neonatal disease, but whether this influences infant immune responses and long-term control of pertussis for a population is unknown.

Finally, the group is interested in the effects of an acellular booster across all age groups. While the effects may be short-lived, the booster is a potential strategy for controlling a population by repeated boosting of immunity. This is another area where using novel immunoassays may aid better understanding.

To find answers, the consortium has established four studies: the Gambia Pertussis study (GaPs) in Gambia and AWARE, the sister study to GaPs in the United Kingdom, addressing the acellular pertussis versus cellular pertussis question; the Pertussis Maternal Immunization Study in Finland (MIFI) addressing maternal immunization; and the Booster against Pertussis (BERT) study across three countries (U.K., the Netherlands, and Finland) looking at acellular booster across age groups.
 

Gambia pertussis study

GaPs is the largest single study in the project and is being run at the Medical Research Council–funded London School of Tropical Medicine center in Gambia. Beate Kampmann, MD, PhD, of Imperial College London, England, is the project lead. It is due to complete in 2022. GaPs seeks to enroll 600 mother/infant pairs and randomize the mothers to either an acellular pertussis booster in pregnancy or a tetanus toxoid control vaccine. Infants are subsequently randomized to an acellular or whole-cell pertussis schedule of primary immunization. The vaccine doses are being given at 2, 3, and 4 months. The primary endpoint is a serological finding being measured at 9 months of age, when the infant would usually receive yellow fever, measles, and rubella vaccination.

GaPs has a number of pathways. Within each of the four arms generated by the two randomizations, the maternal randomization and the infant randomization, there are five subgroups. They are designed to study time points in subgroups A and B after the first dose in more detail, looking at the innate immune responses using gene expression. It will enable researchers to study adaptive immune responses to T cells and B cells after the second dose of vaccine. By employing a range of subgroups, the team can explore the immune profile using the assays referred to above. Such information should provide new insights into the differences between acellular and whole-cell vaccines.
 

The AWARE study

AWARE is the sister study to GaPs and looks at the acellular/whole pertussis issue. Because many developed countries, such as the United Kingdom, have established maternal immunization programs, it is not possible to randomize mothers. Consequently, researchers have opted to recruit infants of mothers who have received an acellular vaccine in pregnancy and randomize them to either an acellular schedule of primary immunization or a whole-cell schedule.

The selected vaccine is ComVac5 from Bharat Biotech. This whole-cell vaccine differs from that used in Gambia. An early obstacle for AWARE has been seeking permission to import a non-conventional vaccine into Europe. It has delayed the anticipated end date to 2023. Participating infants will receive a two-dose schedule at 2 and 4 months of age per their randomization; then, both groups will go on to receive an acellular pertussis booster at 12 months. At all time points, the team will sample blood for cells and serum, as well as mucosal fluid from the nose. Because the mucosal surface is where the action is, this approach will likely generate new data around antibody responses.
 

The MIFI

The Pertussis Maternal Immunization Study in Finland is being run by Jussi Mertsola, of the University of Turku, Finland, and Qiushui He, of the National Public Health Institute, Turku. It is due to complete in late 2021. Where, in the United Kingdom, researchers are unable to randomize mothers because of the current guidelines, researchers in Finland do not have a maternal immunization program to consider. MIFI will randomize 80 mothers, 40 to immunization with acellular pertussis and 40 to a control group. Dr. Kelly stated that whole cell vaccines are not available for use in Finland. Participants will receive a two-dose schedule at 3 and 5 months. Blood samples will then be taken to compare the serological and cellular responses, which will help researchers understand the effects of maternal immunization. In addition, there will be sampling of mucosal fluid using a device that collects a standardized aliquot of fluid.
 

The BERT study

The final clinical element of PERISCOPE presented by Dr. Kelly was the Booster against Pertussis study. This study is near completion. It seeks to examine the use of an acellular booster across different age groups and three countries: the United Kingdom, the Netherlands, and Finland. The study is being coordinated by Guy Berbers, PhD, at the National Institute for Public Health and the Environment in the Netherlands.

BERT comprises four cohorts (A, B, C, D) of different ages: 7-10 years (36 participants), 11-15 years (36 participants), mid-adult (25 participants), and older age (25 participants). After receiving an acellular booster, participants will undergo intense sampling. Sampling will take place immediately after immunization at day 7 and look at adaptive effects, then again at day 28 and day 365.

Because some participants will have already received whole cell or acellular vaccination, this approach will allow researchers to look at the effects of priming (i.e., how long the B cell/T cell antibody responses last).

Involving different countries across Europe ensures wide applicability of results, but also allows researchers to compare the effects of very different immunization histories.

At the end of this ESPID session, Dimitri Diavatopoulos, PhD, assistant professor at the Radboud University Medical Centre Nijmegen, the Netherlands, commented that a future problem in studying pertussis vaccines and their potential clinical application is that most vaccination schedules now involve combination products. Obtaining a stand-alone vaccination may prove difficult, and there may be resistance if it complicates current vaccination programs.

Dr. Kelly acknowledged funding for the PERISCOPE project from GlaxoSmithKline and Pasteur Sanofi.

With increasing whooping cough numbers, developing an effective new vaccine against Bordetella pertussis is a priority. Results from the multifactorial PERISCOPE Project will help scientists and clinicians move forward.

MarianVejcik/Getty Images

Dominic Kelly, PhD, talked about vaccine-induced immunity and provided an overview of ongoing clinical trials in the PERISCOPE (Pertussis Correlates of Protection Europe) project in a key research session at the start of the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. Dr. Kelly, a pediatrician at the Children’s Hospital in Oxford and a member of the Oxford Vaccines Group, leads one of the studies in the project looking at infant vaccination.

Dr. Kelly began his presentation by showing a figure depicting where vaccine-induced immunity fits into the larger suite of clinical studies. These studies involve mouse models, human challenge models, and infection patients. A key theme is the use of a core group of immunoassays across all studies, with the hope that they will allow effective cross comparisons.

Dr. Kelly stated, “If we find a correlate of protection in the challenge model, we can then interpret the vaccine studies in the light of that because we are using standardized constant immunoassays.”

The assays being used depend in part on the specific study and the volume of blood available. They will generally include Bordetella-specific antibody and functional antibody assays, as well as interesting studies collecting mucosal samples from infants and adults to look at serological responses. Also under examination are a range of enzyme-linked immune absorbent spot, flow cytometry, and culture techniques looking at Memory B cells, T cells, and gene expression.

Complementing these assay studies, PERISCOPE includes a series of clinical investigations designed to throw light on three areas of interest, described below:

First, researchers hope to gain a better understanding regarding the effects of the original whole cell vaccine versus the current acellular variety. The former uses an inactivated version of the whole organism. Epidemiological studies, animal data, and experience in the field demonstrate that whole-cell vaccination results in a broad, long-lasting, and effective immune response.

By comparison, the acellular pertussis vaccine consists of between three and five protein components, which are purified from cultured Bordetella pertussis. While it is an effective vaccine, its effects are less durable; routine use in some countries is associated with cyclical outbreaks of increasing severity.

A second issue for researchers involved in the PERISCOPE project concerns the effects of maternal immunization. In the United Kingdom in 2012, for example, an increasing number of cases were noted 6-7 years after adoption of an acellular vaccine for routine vaccination in the 2nd-3rd trimester of pregnancy. Vaccination appears to effectively control neonatal disease, but whether this influences infant immune responses and long-term control of pertussis for a population is unknown.

Finally, the group is interested in the effects of an acellular booster across all age groups. While the effects may be short-lived, the booster is a potential strategy for controlling a population by repeated boosting of immunity. This is another area where using novel immunoassays may aid better understanding.

To find answers, the consortium has established four studies: the Gambia Pertussis study (GaPs) in Gambia and AWARE, the sister study to GaPs in the United Kingdom, addressing the acellular pertussis versus cellular pertussis question; the Pertussis Maternal Immunization Study in Finland (MIFI) addressing maternal immunization; and the Booster against Pertussis (BERT) study across three countries (U.K., the Netherlands, and Finland) looking at acellular booster across age groups.
 

Gambia pertussis study

GaPs is the largest single study in the project and is being run at the Medical Research Council–funded London School of Tropical Medicine center in Gambia. Beate Kampmann, MD, PhD, of Imperial College London, England, is the project lead. It is due to complete in 2022. GaPs seeks to enroll 600 mother/infant pairs and randomize the mothers to either an acellular pertussis booster in pregnancy or a tetanus toxoid control vaccine. Infants are subsequently randomized to an acellular or whole-cell pertussis schedule of primary immunization. The vaccine doses are being given at 2, 3, and 4 months. The primary endpoint is a serological finding being measured at 9 months of age, when the infant would usually receive yellow fever, measles, and rubella vaccination.

GaPs has a number of pathways. Within each of the four arms generated by the two randomizations, the maternal randomization and the infant randomization, there are five subgroups. They are designed to study time points in subgroups A and B after the first dose in more detail, looking at the innate immune responses using gene expression. It will enable researchers to study adaptive immune responses to T cells and B cells after the second dose of vaccine. By employing a range of subgroups, the team can explore the immune profile using the assays referred to above. Such information should provide new insights into the differences between acellular and whole-cell vaccines.
 

The AWARE study

AWARE is the sister study to GaPs and looks at the acellular/whole pertussis issue. Because many developed countries, such as the United Kingdom, have established maternal immunization programs, it is not possible to randomize mothers. Consequently, researchers have opted to recruit infants of mothers who have received an acellular vaccine in pregnancy and randomize them to either an acellular schedule of primary immunization or a whole-cell schedule.

The selected vaccine is ComVac5 from Bharat Biotech. This whole-cell vaccine differs from that used in Gambia. An early obstacle for AWARE has been seeking permission to import a non-conventional vaccine into Europe. It has delayed the anticipated end date to 2023. Participating infants will receive a two-dose schedule at 2 and 4 months of age per their randomization; then, both groups will go on to receive an acellular pertussis booster at 12 months. At all time points, the team will sample blood for cells and serum, as well as mucosal fluid from the nose. Because the mucosal surface is where the action is, this approach will likely generate new data around antibody responses.
 

The MIFI

The Pertussis Maternal Immunization Study in Finland is being run by Jussi Mertsola, of the University of Turku, Finland, and Qiushui He, of the National Public Health Institute, Turku. It is due to complete in late 2021. Where, in the United Kingdom, researchers are unable to randomize mothers because of the current guidelines, researchers in Finland do not have a maternal immunization program to consider. MIFI will randomize 80 mothers, 40 to immunization with acellular pertussis and 40 to a control group. Dr. Kelly stated that whole cell vaccines are not available for use in Finland. Participants will receive a two-dose schedule at 3 and 5 months. Blood samples will then be taken to compare the serological and cellular responses, which will help researchers understand the effects of maternal immunization. In addition, there will be sampling of mucosal fluid using a device that collects a standardized aliquot of fluid.
 

The BERT study

The final clinical element of PERISCOPE presented by Dr. Kelly was the Booster against Pertussis study. This study is near completion. It seeks to examine the use of an acellular booster across different age groups and three countries: the United Kingdom, the Netherlands, and Finland. The study is being coordinated by Guy Berbers, PhD, at the National Institute for Public Health and the Environment in the Netherlands.

BERT comprises four cohorts (A, B, C, D) of different ages: 7-10 years (36 participants), 11-15 years (36 participants), mid-adult (25 participants), and older age (25 participants). After receiving an acellular booster, participants will undergo intense sampling. Sampling will take place immediately after immunization at day 7 and look at adaptive effects, then again at day 28 and day 365.

Because some participants will have already received whole cell or acellular vaccination, this approach will allow researchers to look at the effects of priming (i.e., how long the B cell/T cell antibody responses last).

Involving different countries across Europe ensures wide applicability of results, but also allows researchers to compare the effects of very different immunization histories.

At the end of this ESPID session, Dimitri Diavatopoulos, PhD, assistant professor at the Radboud University Medical Centre Nijmegen, the Netherlands, commented that a future problem in studying pertussis vaccines and their potential clinical application is that most vaccination schedules now involve combination products. Obtaining a stand-alone vaccination may prove difficult, and there may be resistance if it complicates current vaccination programs.

Dr. Kelly acknowledged funding for the PERISCOPE project from GlaxoSmithKline and Pasteur Sanofi.

With increasing whooping cough numbers, developing an effective new vaccine against Bordetella pertussis is a priority. Results from the multifactorial PERISCOPE Project will help scientists and clinicians move forward.

MarianVejcik/Getty Images

Dominic Kelly, PhD, talked about vaccine-induced immunity and provided an overview of ongoing clinical trials in the PERISCOPE (Pertussis Correlates of Protection Europe) project in a key research session at the start of the annual meeting of the European Society for Paediatric Infectious Diseases, held virtually this year. Dr. Kelly, a pediatrician at the Children’s Hospital in Oxford and a member of the Oxford Vaccines Group, leads one of the studies in the project looking at infant vaccination.

Dr. Kelly began his presentation by showing a figure depicting where vaccine-induced immunity fits into the larger suite of clinical studies. These studies involve mouse models, human challenge models, and infection patients. A key theme is the use of a core group of immunoassays across all studies, with the hope that they will allow effective cross comparisons.

Dr. Kelly stated, “If we find a correlate of protection in the challenge model, we can then interpret the vaccine studies in the light of that because we are using standardized constant immunoassays.”

The assays being used depend in part on the specific study and the volume of blood available. They will generally include Bordetella-specific antibody and functional antibody assays, as well as interesting studies collecting mucosal samples from infants and adults to look at serological responses. Also under examination are a range of enzyme-linked immune absorbent spot, flow cytometry, and culture techniques looking at Memory B cells, T cells, and gene expression.

Complementing these assay studies, PERISCOPE includes a series of clinical investigations designed to throw light on three areas of interest, described below:

First, researchers hope to gain a better understanding regarding the effects of the original whole cell vaccine versus the current acellular variety. The former uses an inactivated version of the whole organism. Epidemiological studies, animal data, and experience in the field demonstrate that whole-cell vaccination results in a broad, long-lasting, and effective immune response.

By comparison, the acellular pertussis vaccine consists of between three and five protein components, which are purified from cultured Bordetella pertussis. While it is an effective vaccine, its effects are less durable; routine use in some countries is associated with cyclical outbreaks of increasing severity.

A second issue for researchers involved in the PERISCOPE project concerns the effects of maternal immunization. In the United Kingdom in 2012, for example, an increasing number of cases were noted 6-7 years after adoption of an acellular vaccine for routine vaccination in the 2nd-3rd trimester of pregnancy. Vaccination appears to effectively control neonatal disease, but whether this influences infant immune responses and long-term control of pertussis for a population is unknown.

Finally, the group is interested in the effects of an acellular booster across all age groups. While the effects may be short-lived, the booster is a potential strategy for controlling a population by repeated boosting of immunity. This is another area where using novel immunoassays may aid better understanding.

To find answers, the consortium has established four studies: the Gambia Pertussis study (GaPs) in Gambia and AWARE, the sister study to GaPs in the United Kingdom, addressing the acellular pertussis versus cellular pertussis question; the Pertussis Maternal Immunization Study in Finland (MIFI) addressing maternal immunization; and the Booster against Pertussis (BERT) study across three countries (U.K., the Netherlands, and Finland) looking at acellular booster across age groups.
 

Gambia pertussis study

GaPs is the largest single study in the project and is being run at the Medical Research Council–funded London School of Tropical Medicine center in Gambia. Beate Kampmann, MD, PhD, of Imperial College London, England, is the project lead. It is due to complete in 2022. GaPs seeks to enroll 600 mother/infant pairs and randomize the mothers to either an acellular pertussis booster in pregnancy or a tetanus toxoid control vaccine. Infants are subsequently randomized to an acellular or whole-cell pertussis schedule of primary immunization. The vaccine doses are being given at 2, 3, and 4 months. The primary endpoint is a serological finding being measured at 9 months of age, when the infant would usually receive yellow fever, measles, and rubella vaccination.

GaPs has a number of pathways. Within each of the four arms generated by the two randomizations, the maternal randomization and the infant randomization, there are five subgroups. They are designed to study time points in subgroups A and B after the first dose in more detail, looking at the innate immune responses using gene expression. It will enable researchers to study adaptive immune responses to T cells and B cells after the second dose of vaccine. By employing a range of subgroups, the team can explore the immune profile using the assays referred to above. Such information should provide new insights into the differences between acellular and whole-cell vaccines.
 

The AWARE study

AWARE is the sister study to GaPs and looks at the acellular/whole pertussis issue. Because many developed countries, such as the United Kingdom, have established maternal immunization programs, it is not possible to randomize mothers. Consequently, researchers have opted to recruit infants of mothers who have received an acellular vaccine in pregnancy and randomize them to either an acellular schedule of primary immunization or a whole-cell schedule.

The selected vaccine is ComVac5 from Bharat Biotech. This whole-cell vaccine differs from that used in Gambia. An early obstacle for AWARE has been seeking permission to import a non-conventional vaccine into Europe. It has delayed the anticipated end date to 2023. Participating infants will receive a two-dose schedule at 2 and 4 months of age per their randomization; then, both groups will go on to receive an acellular pertussis booster at 12 months. At all time points, the team will sample blood for cells and serum, as well as mucosal fluid from the nose. Because the mucosal surface is where the action is, this approach will likely generate new data around antibody responses.
 

The MIFI

The Pertussis Maternal Immunization Study in Finland is being run by Jussi Mertsola, of the University of Turku, Finland, and Qiushui He, of the National Public Health Institute, Turku. It is due to complete in late 2021. Where, in the United Kingdom, researchers are unable to randomize mothers because of the current guidelines, researchers in Finland do not have a maternal immunization program to consider. MIFI will randomize 80 mothers, 40 to immunization with acellular pertussis and 40 to a control group. Dr. Kelly stated that whole cell vaccines are not available for use in Finland. Participants will receive a two-dose schedule at 3 and 5 months. Blood samples will then be taken to compare the serological and cellular responses, which will help researchers understand the effects of maternal immunization. In addition, there will be sampling of mucosal fluid using a device that collects a standardized aliquot of fluid.
 

The BERT study

The final clinical element of PERISCOPE presented by Dr. Kelly was the Booster against Pertussis study. This study is near completion. It seeks to examine the use of an acellular booster across different age groups and three countries: the United Kingdom, the Netherlands, and Finland. The study is being coordinated by Guy Berbers, PhD, at the National Institute for Public Health and the Environment in the Netherlands.

BERT comprises four cohorts (A, B, C, D) of different ages: 7-10 years (36 participants), 11-15 years (36 participants), mid-adult (25 participants), and older age (25 participants). After receiving an acellular booster, participants will undergo intense sampling. Sampling will take place immediately after immunization at day 7 and look at adaptive effects, then again at day 28 and day 365.

Because some participants will have already received whole cell or acellular vaccination, this approach will allow researchers to look at the effects of priming (i.e., how long the B cell/T cell antibody responses last).

Involving different countries across Europe ensures wide applicability of results, but also allows researchers to compare the effects of very different immunization histories.

At the end of this ESPID session, Dimitri Diavatopoulos, PhD, assistant professor at the Radboud University Medical Centre Nijmegen, the Netherlands, commented that a future problem in studying pertussis vaccines and their potential clinical application is that most vaccination schedules now involve combination products. Obtaining a stand-alone vaccination may prove difficult, and there may be resistance if it complicates current vaccination programs.

Dr. Kelly acknowledged funding for the PERISCOPE project from GlaxoSmithKline and Pasteur Sanofi.

Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and social interaction, including deficits in social reciprocity, nonverbal communicative behaviors used for social interaction, and skills in developing, maintaining, and understanding relationships.¹ In addition, the diagnosis of ASD requires the presence of restricted, repetitive patterns of behavior, interests, or activities.

Initially, ASD was considered a rare condition. In recent years, the reported prevalence has increased substantially. The most recent estimated prevalence is 1 in 68 children at age 8, with a male-to-female ratio of 4 to 1.²

Behavioral interventions are considered to be the most effective treatment for the core symptoms of ASD. Pharmacologic interventions are used primarily to treat associated or comorbid symptoms rather than the core symptoms. Aggression, self-injurious behavior, and irritability are common targets of pharmacotherapy in patients with ASD. Studies have provided support for the use of antipsychotic agents to treat irritability and associated aggressive behaviors in patients with autism,³ but because these agents have significant adverse effects—including extrapyramidal side effects, somnolence, and weight gain—their use requires a careful risk/benefit assessment. Stimulants have also been shown to be effective in treating comorbid attention-deficit/hyperactivity symptoms. The use of selective serotonin reuptake inhibitors (SSRIs) to manage repetitive behaviors and anxiety is also common.

Here, we review 7 recent studies of the pharmacologic management of ASD (Table).^4-10 These studies examined the role of SSRIs (sertraline, fluoxetine), an acetylcholinesterase inhibitor (donepezil), atypical antipsychotics (risperidone, aripiprazole, lurasidone), natural supplements (vitamin D, omega-3), a diuretic (bumetanide), and a glutamatergic modulator (riluzole) in the treatment of ASD symptoms.

1. Potter LA, Scholze DA, Biag HMB, et al. A randomized controlled trial of sertraline in young children with autism spectrum disorder. Front Psychiatry. 2019;10:810.

Several studies have shown that SSRIs improve language development in children with Fragile X syndrome, based on the Mullen Scales of Early Learning (MSEL). A previously published trial involving children with Fragile X syndrome and comorbid ASD found that sertraline improved expressive language development. Potter et al⁴ examined the role of sertraline in children with ASD only.

Study Design

• In this randomized, double-blind, placebo-controlled trial, 58 children age 24 to 72 months with ASD received low-dose sertraline or placebo for 6 months.
• Of the 179 participants who were screened for eligibility, 58 were included in the study. Of these 58 participants, 32 received sertraline and 26 received placebo. The numbers of participants who discontinued from the sertraline and placebo arms were 8 and 5, respectively.
• Among those in the sertraline group, participants age <48 months received 2.5 mg/d, and those age ≥48 months received 5 mg/d.

Outcomes

• No significant differences were found on the primary outcome (MSEL expressive language raw score and age-equivalent combined score) or secondary outcomes (including Clinical Global Impressions–Improvement [CGI-I] scale at 3 months and end of treatment), as per intent-to-treat analyses.
• Sertraline was well tolerated. There was no difference in adverse effects between treatment groups and no serious adverse events.

Conclusion

• Although potentially useful for language development in patients with Fragile X syndrome with comorbid ASD, SSRIs such as sertraline have not proven efficacious for improving expressive language in patients with non-syndromic ASD.
• While 6-month treatment with low-dose sertraline in young children with ASD appears safe, the long-term effects are unknown.

Continue to: Gabis et al⁵ examined the safety...

2. Gabis LV, Ben-Hur R, Shefer S, et al. Improvement of language in children with autism with combined donepezil and choline treatment. J Mol Neurosci. 2019;69(2):224-234.

Gabis et al⁵ examined the safety and efficacy of utilizing donepezil, an acetylcholinesterase inhibitor, plus a choline supplement to treat both core features and associated symptoms in children and adolescents with ASD.

Study design

• This 9-month randomized, double-blind trial included 60 children/adolescents with ASD who were randomly assigned to receive placebo or donepezil plus a choline supplement. Participants underwent a baseline evaluation (E1), 12 weeks of treatment and re-evaluation (E2), 6 months of washout, and a final evaluation (E3).
• The baseline and final evaluations assessed changes in language performance, adaptive functioning, sleep habits, autism severity, clinical impression, and intellectual abilities. The evaluation after 12 weeks of treatment (E2) included all of these measures except intellectual abilities.

Outcomes

• Patients treated with donepezil plus a choline supplement had significant improvement in receptive language skills between E1 and E3 (P = .003).
• Patients treated with donepezil plus a choline supplement had significant worsening in scores on the Autism Treatment Evaluation Checklist (ATEC) health/physical behavior subscale between E1 and E2 (P = .012) and between E1 and E3 (P = .021).
• Improvement in receptive language skills was significant only in patients age 5 to 10 years (P = .047), whereas worsening in ATEC health/physical behavior subscale score was significant only in patients age 10 to 16 years (P = .024).
• Patients treated with donepezil plus a choline supplement reported higher percentages of gastrointestinal disturbance when compared with placebo (P = .007), and patients in the adolescent subgroup had a significant increase in irritability (P = .035).

Conclusion

• Patients age 5 to 10 years treated with donepezil plus a choline supplement exhibited improved receptive language skills. This treatment was less effective in patients age >10 years, and this group also exhibited behavioral worsening.
• Gastrointestinal disturbances were the main adverse effect of treatment with donepezil plus a choline supplement.

Continue to: The persistence of excitatory...

3. James BJ, Gales MA, Gales BJ. Bumetanide for autism spectrum disorder in children: a review of randomized controlled trials. Ann Pharmacother. 2019;53(5):537-544.

The persistence of excitatory gamma-aminobutyric acid (GABA) signaling has been found in patients with ASD. Bumetanide is a sodium-potassium-chloride cotransporter 1 (NKCC1) antagonist that not only decreases intracellular chloride, but also aberrantly decreases GABA signaling. This potent loop diuretic is a proposed treatment for symptoms of ASD. James et al⁶ evaluated the safety and efficacy of bumetanide use in children with ASD.
 

Study design

• Researchers searched the PubMed and Ovid MEDLINE databases for the terms “autism” and “bumetanide” between 1946 and 2018. A total of 26 articles were screened by title, 7 were screened by full text, and 3 articles were included in the study. The remaining articles were excluded due to study design and use of non-human subjects.
• All 3 randomized controlled trials evaluated the effects of low-dose oral bumetanide (most common dose was 0.5 mg twice daily) in a total of 208 patients age 2 to 18 years.
• Measurement scales used in the 3 studies included the Childhood Autism Rating Scale (CARS), Clinical Global Impressions Scale (CGI), Autism Behavioral Checklist (ABC), Social Responsiveness Scale (SRS), and Autism Diagnostic Observation Schedule-Generic (ADOS-G).

Outcomes

• Bumetanide improved scores on multiple autism assessment scales, including CARS, but the degree of improvement was not consistent across the 3 trials.
• There was a statistically significant improvement in ASD symptoms as measured by CGI in all 3 trials, and statistically significant improvements on the ABC and SRS in 2 trials. No improvements were noted on the ADOS-G in any of the trials.
• No dose-effect correlation was identified, but hypokalemia and polyuria were more prevalent with higher doses of bumetanide.

Conclusion

• Low-dose oral bumetanide improved social communication, social interactions, and restricted interests in patients with moderate to severe ASD. However, the 3 trials used different evaluation methods and observed varying degrees of improvement, which makes it difficult to make recommendations for or against the use of bumetanide.
• Streamlined trials with a consensus on evaluation methodology are needed to draw conclusions about the efficacy and safety of bumetanide as a treatment for ASD.

Continue to: The use of SSRIs to target...

4. Li C, Bai Y, Jin C, et al. Efficacy and safety of fluoxetine in autism spectrum disorder: a meta-analysis. Am J Ther. 2020;27(3):e312-e315.

The use of SSRIs to target symptoms of ASD has been long studied because many children with ASD have elevated serotonin levels. Several SSRIs, including fluoxetine, are FDA-approved for the treatment of obsessive-compulsive disorder, anxiety, and depression. Currently, no SSRIs are FDA-approved for treating ASD. In a meta-analysis, Li et al⁷ evaluated the use of fluoxetine for ASD.
 

Study design

• Two independent researchers searched for studies of fluoxetine treatment for ASD in Embase, Google Scholar, Ovid SP, and PubMed, with disagreement resolved by consensus.
• The researchers extracted the study design, patient demographics, and outcomes (inter-rater reliability kappa = 0.93). The primary outcomes were response rate of patients treated with fluoxetine, and change from baseline in ABC, ATEC, CARS, CGI, and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores after fluoxetine treatment.

Outcomes

• This meta-analysis included 13 studies in which fluoxetine was used to treat a total of 303 patients with ASD. The median treatment duration was 6 months, the average age of participants was 15.23 years, and most participants (72%) were male.
• The response rate of patients treated with fluoxetine was 75%, with significant mean changes from baseline in ABC score (Helvetica Neue LT Std−3.42), ATEC score (Helvetica Neue LT Std−2.04), CGI score (Helvetica Neue LT Std−0.93), and Y-BOCS score (Helvetica Neue LT Std−1.86).
• A significantly higher incidence of hyperactivity/restlessness/agitation was noted with fluoxetine.

Conclusion

• Although 75% of participants re­sponded to fluoxetine, the limitations of this meta-analysis included low power, inadequate quality of the included studies, and high statistical heterogeneity. In addition, the analysis found a high incidence of hyperactivity/restlessness associated with fluoxetine.
• Future randomized controlled studies may provide further clarification on managing symptoms of ASD with SSRIs.

Continue to: Irritability is a common comorbid...

5. Fallah MS, Shaikh MR, Neupane B, et al. Atypical antipsychotics for irritability in pediatric autism: a systematic review and network meta-analysis. J Child Adolesc Psychopharmacol. 2019;29(3):168-180.

Irritability is a common comorbid symptom in children with ASD. Two second-generation antipsychotics (SGAs)—risperidone and aripiprazole—are FDA-approved for irritability associated with ASD. Fallah et al⁸ examined the efficacy of several SGAs for treating irritability.

Study design

• This review and meta-analysis included 8 studies identified from Medline, PsycINFO, and Embase from inception to March 2018. It included double-blind, randomized controlled trials that used the Aberrant Behavior Checklist Irritability (ABC-I) to measure irritability.
• The main outcome was change in degree of irritability.
• The 8 studies compared the efficacy of risperidone, aripiprazole, lurasidone, and placebo in a total of 878 patients.

Outcomes

• Risperidone reduced ABC-I scores more than aripiprazole, lurasidone, or placebo.
• Mean differences in ABC-I scores were Helvetica Neue LT Std−6.89 for risperidone, Helvetica Neue LT Std−6.62 for aripiprazole, and Helvetica Neue LT Std−1.61 for lurasidone.

Conclusion

• Risperidone and aripiprazole were efficacious and safe for children with ASD-associated irritability.
• Lurasidone may minimally improve irritability in children with ASD.

Continue to: Irritability and hyperactivity are common...

6. Mazahery H, Conlon CA, Beck KL, et al. A randomised controlled trial of vitamin D and omega-3 long chain polyunsaturated fatty acids in the treatment of irritability and hyperactivity among children with autism spectrum disorder. J Steroid Biochem Mol Biol. 2019;187:9-16.

Irritability and hyperactivity are common comorbid symptoms in children with ASD and have been linked to lower quality of life, poor adaptive functioning, and lower responsiveness to treatments when compared to children without comorbid problem behaviors. Mazahery et al⁹ evaluated the efficacy of vitamin D, omega-3 long-chain polyunsaturated fatty acids (LCPUFA), or both on irritability and hyperactivity.

Study design

• In a 1-year, double-blind, placebo-controlled trial, 73 children age 2.5 to 8 years with ASD were randomly assigned to receive placebo; vitamin D, 2000 IU/d (VID); omega-3 LCPUFA, 722 mg/d (OM); or both in the aforementioned doses.
• The primary outcome was reduction in the Aberrant Behavior Checklist in the domains of irritability and hyperactivity. Caregivers also completed weekly surveys regarding adverse events, compliance, and utilization of behavioral therapies.
• Of 111 children enrolled, 73 completed the 12 months of treatment.

Outcomes

• Children who received OM and VID had a greater reduction in irritability than those who received placebo (P = .001 and P = .01, respectively).
• Children who received VID also had a reduction in irritability (P = .047).
• An explanatory analysis revealed that OM also reduced lethargy (based on the Aberrant Behavior Checklist) more significantly than placebo (P = .02 adjusted for covariates).

Conclusion

• Treatment with vitamin D, 2000 IU/d, reduced irritability and hyperactivity.
• Treatment with omega-3 LCPUFA, 722 mg/d, reduced hyperactivity and lethargy.

Continue to: Glutamatergic dysregulation has been...

7. Wink LK, Adams R, Horn PS, et al. A randomized placebo-controlled cross-over pilot study of riluzole for drug-refractory irritability in autism spectrum disorder. J Autism Dev Disord. 2018;48(9):3051-3060.

Glutamatergic dysregulation has been identified as a potential cause of ASD. Riluzole, a glutamatergic modulator that is FDA-approved for treating amyotrophic lateral sclerosis, is a drug of interest for the treatment of ASD-related irritability due to this proposed mechanism. Wink et al¹⁰ evaluated riluzole for irritability in patients with ASD.

Study design

• This randomized, double-blind, placebo-controlled, crossover pilot study evaluated the tolerability and safety of adjunctive riluzole treatment for drug-refractory irritability in 8 patients with ASD.
• Participants were age 12 to 25 years, had a diagnosis of ASD confirmed by the autism diagnostic observation schedule 2, and an ABC-I subscale score ≥18. Participants receiving ≥2 psychotropic medications or glutamatergic/GABA-modulating medications were excluded.
• Participants received either 5 weeks of riluzole followed by 5 weeks of placebo, or vice versa; both groups then had a 2-week washout period.
• Riluzole was started at 50 mg/d, and then increased in 50 mg/d–increments to a maximum of 200 mg/d by Week 4.
• Primary outcome measures were change in score on the ABC-I and CGI-I.

Outcomes

• No significant treatment effects were identified.
• All participants tolerated riluzole, 200 mg/d, but increased dosages did not result in a higher overall treatment effect.
• There were no clinically significant adverse effects or laboratory abnormalities.

Conclusion

• Riluzole, 200 mg/d, was well tolerated but had no significant effect on irritability in adolescents with ASD.

Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and social interaction, including deficits in social reciprocity, nonverbal communicative behaviors used for social interaction, and skills in developing, maintaining, and understanding relationships.¹ In addition, the diagnosis of ASD requires the presence of restricted, repetitive patterns of behavior, interests, or activities.

Initially, ASD was considered a rare condition. In recent years, the reported prevalence has increased substantially. The most recent estimated prevalence is 1 in 68 children at age 8, with a male-to-female ratio of 4 to 1.²

Behavioral interventions are considered to be the most effective treatment for the core symptoms of ASD. Pharmacologic interventions are used primarily to treat associated or comorbid symptoms rather than the core symptoms. Aggression, self-injurious behavior, and irritability are common targets of pharmacotherapy in patients with ASD. Studies have provided support for the use of antipsychotic agents to treat irritability and associated aggressive behaviors in patients with autism,³ but because these agents have significant adverse effects—including extrapyramidal side effects, somnolence, and weight gain—their use requires a careful risk/benefit assessment. Stimulants have also been shown to be effective in treating comorbid attention-deficit/hyperactivity symptoms. The use of selective serotonin reuptake inhibitors (SSRIs) to manage repetitive behaviors and anxiety is also common.

Here, we review 7 recent studies of the pharmacologic management of ASD (Table).^4-10 These studies examined the role of SSRIs (sertraline, fluoxetine), an acetylcholinesterase inhibitor (donepezil), atypical antipsychotics (risperidone, aripiprazole, lurasidone), natural supplements (vitamin D, omega-3), a diuretic (bumetanide), and a glutamatergic modulator (riluzole) in the treatment of ASD symptoms.

1. Potter LA, Scholze DA, Biag HMB, et al. A randomized controlled trial of sertraline in young children with autism spectrum disorder. Front Psychiatry. 2019;10:810.

Several studies have shown that SSRIs improve language development in children with Fragile X syndrome, based on the Mullen Scales of Early Learning (MSEL). A previously published trial involving children with Fragile X syndrome and comorbid ASD found that sertraline improved expressive language development. Potter et al⁴ examined the role of sertraline in children with ASD only.

Study Design

• In this randomized, double-blind, placebo-controlled trial, 58 children age 24 to 72 months with ASD received low-dose sertraline or placebo for 6 months.
• Of the 179 participants who were screened for eligibility, 58 were included in the study. Of these 58 participants, 32 received sertraline and 26 received placebo. The numbers of participants who discontinued from the sertraline and placebo arms were 8 and 5, respectively.
• Among those in the sertraline group, participants age <48 months received 2.5 mg/d, and those age ≥48 months received 5 mg/d.

Outcomes

• No significant differences were found on the primary outcome (MSEL expressive language raw score and age-equivalent combined score) or secondary outcomes (including Clinical Global Impressions–Improvement [CGI-I] scale at 3 months and end of treatment), as per intent-to-treat analyses.
• Sertraline was well tolerated. There was no difference in adverse effects between treatment groups and no serious adverse events.

Conclusion

• Although potentially useful for language development in patients with Fragile X syndrome with comorbid ASD, SSRIs such as sertraline have not proven efficacious for improving expressive language in patients with non-syndromic ASD.
• While 6-month treatment with low-dose sertraline in young children with ASD appears safe, the long-term effects are unknown.

Continue to: Gabis et al⁵ examined the safety...

2. Gabis LV, Ben-Hur R, Shefer S, et al. Improvement of language in children with autism with combined donepezil and choline treatment. J Mol Neurosci. 2019;69(2):224-234.

Gabis et al⁵ examined the safety and efficacy of utilizing donepezil, an acetylcholinesterase inhibitor, plus a choline supplement to treat both core features and associated symptoms in children and adolescents with ASD.

Study design

• This 9-month randomized, double-blind trial included 60 children/adolescents with ASD who were randomly assigned to receive placebo or donepezil plus a choline supplement. Participants underwent a baseline evaluation (E1), 12 weeks of treatment and re-evaluation (E2), 6 months of washout, and a final evaluation (E3).
• The baseline and final evaluations assessed changes in language performance, adaptive functioning, sleep habits, autism severity, clinical impression, and intellectual abilities. The evaluation after 12 weeks of treatment (E2) included all of these measures except intellectual abilities.

Outcomes

• Patients treated with donepezil plus a choline supplement had significant improvement in receptive language skills between E1 and E3 (P = .003).
• Patients treated with donepezil plus a choline supplement had significant worsening in scores on the Autism Treatment Evaluation Checklist (ATEC) health/physical behavior subscale between E1 and E2 (P = .012) and between E1 and E3 (P = .021).
• Improvement in receptive language skills was significant only in patients age 5 to 10 years (P = .047), whereas worsening in ATEC health/physical behavior subscale score was significant only in patients age 10 to 16 years (P = .024).
• Patients treated with donepezil plus a choline supplement reported higher percentages of gastrointestinal disturbance when compared with placebo (P = .007), and patients in the adolescent subgroup had a significant increase in irritability (P = .035).

Conclusion

• Patients age 5 to 10 years treated with donepezil plus a choline supplement exhibited improved receptive language skills. This treatment was less effective in patients age >10 years, and this group also exhibited behavioral worsening.
• Gastrointestinal disturbances were the main adverse effect of treatment with donepezil plus a choline supplement.

Continue to: The persistence of excitatory...

3. James BJ, Gales MA, Gales BJ. Bumetanide for autism spectrum disorder in children: a review of randomized controlled trials. Ann Pharmacother. 2019;53(5):537-544.

The persistence of excitatory gamma-aminobutyric acid (GABA) signaling has been found in patients with ASD. Bumetanide is a sodium-potassium-chloride cotransporter 1 (NKCC1) antagonist that not only decreases intracellular chloride, but also aberrantly decreases GABA signaling. This potent loop diuretic is a proposed treatment for symptoms of ASD. James et al⁶ evaluated the safety and efficacy of bumetanide use in children with ASD.
 

Study design

• Researchers searched the PubMed and Ovid MEDLINE databases for the terms “autism” and “bumetanide” between 1946 and 2018. A total of 26 articles were screened by title, 7 were screened by full text, and 3 articles were included in the study. The remaining articles were excluded due to study design and use of non-human subjects.
• All 3 randomized controlled trials evaluated the effects of low-dose oral bumetanide (most common dose was 0.5 mg twice daily) in a total of 208 patients age 2 to 18 years.
• Measurement scales used in the 3 studies included the Childhood Autism Rating Scale (CARS), Clinical Global Impressions Scale (CGI), Autism Behavioral Checklist (ABC), Social Responsiveness Scale (SRS), and Autism Diagnostic Observation Schedule-Generic (ADOS-G).

Outcomes

• Bumetanide improved scores on multiple autism assessment scales, including CARS, but the degree of improvement was not consistent across the 3 trials.
• There was a statistically significant improvement in ASD symptoms as measured by CGI in all 3 trials, and statistically significant improvements on the ABC and SRS in 2 trials. No improvements were noted on the ADOS-G in any of the trials.
• No dose-effect correlation was identified, but hypokalemia and polyuria were more prevalent with higher doses of bumetanide.

Conclusion

• Low-dose oral bumetanide improved social communication, social interactions, and restricted interests in patients with moderate to severe ASD. However, the 3 trials used different evaluation methods and observed varying degrees of improvement, which makes it difficult to make recommendations for or against the use of bumetanide.
• Streamlined trials with a consensus on evaluation methodology are needed to draw conclusions about the efficacy and safety of bumetanide as a treatment for ASD.

Continue to: The use of SSRIs to target...

4. Li C, Bai Y, Jin C, et al. Efficacy and safety of fluoxetine in autism spectrum disorder: a meta-analysis. Am J Ther. 2020;27(3):e312-e315.

The use of SSRIs to target symptoms of ASD has been long studied because many children with ASD have elevated serotonin levels. Several SSRIs, including fluoxetine, are FDA-approved for the treatment of obsessive-compulsive disorder, anxiety, and depression. Currently, no SSRIs are FDA-approved for treating ASD. In a meta-analysis, Li et al⁷ evaluated the use of fluoxetine for ASD.
 

Study design

• Two independent researchers searched for studies of fluoxetine treatment for ASD in Embase, Google Scholar, Ovid SP, and PubMed, with disagreement resolved by consensus.
• The researchers extracted the study design, patient demographics, and outcomes (inter-rater reliability kappa = 0.93). The primary outcomes were response rate of patients treated with fluoxetine, and change from baseline in ABC, ATEC, CARS, CGI, and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores after fluoxetine treatment.

Outcomes

• This meta-analysis included 13 studies in which fluoxetine was used to treat a total of 303 patients with ASD. The median treatment duration was 6 months, the average age of participants was 15.23 years, and most participants (72%) were male.
• The response rate of patients treated with fluoxetine was 75%, with significant mean changes from baseline in ABC score (Helvetica Neue LT Std−3.42), ATEC score (Helvetica Neue LT Std−2.04), CGI score (Helvetica Neue LT Std−0.93), and Y-BOCS score (Helvetica Neue LT Std−1.86).
• A significantly higher incidence of hyperactivity/restlessness/agitation was noted with fluoxetine.

Conclusion

• Although 75% of participants re­sponded to fluoxetine, the limitations of this meta-analysis included low power, inadequate quality of the included studies, and high statistical heterogeneity. In addition, the analysis found a high incidence of hyperactivity/restlessness associated with fluoxetine.
• Future randomized controlled studies may provide further clarification on managing symptoms of ASD with SSRIs.

Continue to: Irritability is a common comorbid...

5. Fallah MS, Shaikh MR, Neupane B, et al. Atypical antipsychotics for irritability in pediatric autism: a systematic review and network meta-analysis. J Child Adolesc Psychopharmacol. 2019;29(3):168-180.

Irritability is a common comorbid symptom in children with ASD. Two second-generation antipsychotics (SGAs)—risperidone and aripiprazole—are FDA-approved for irritability associated with ASD. Fallah et al⁸ examined the efficacy of several SGAs for treating irritability.

Study design

• This review and meta-analysis included 8 studies identified from Medline, PsycINFO, and Embase from inception to March 2018. It included double-blind, randomized controlled trials that used the Aberrant Behavior Checklist Irritability (ABC-I) to measure irritability.
• The main outcome was change in degree of irritability.
• The 8 studies compared the efficacy of risperidone, aripiprazole, lurasidone, and placebo in a total of 878 patients.

Outcomes

• Risperidone reduced ABC-I scores more than aripiprazole, lurasidone, or placebo.
• Mean differences in ABC-I scores were Helvetica Neue LT Std−6.89 for risperidone, Helvetica Neue LT Std−6.62 for aripiprazole, and Helvetica Neue LT Std−1.61 for lurasidone.

Conclusion

• Risperidone and aripiprazole were efficacious and safe for children with ASD-associated irritability.
• Lurasidone may minimally improve irritability in children with ASD.

Continue to: Irritability and hyperactivity are common...

6. Mazahery H, Conlon CA, Beck KL, et al. A randomised controlled trial of vitamin D and omega-3 long chain polyunsaturated fatty acids in the treatment of irritability and hyperactivity among children with autism spectrum disorder. J Steroid Biochem Mol Biol. 2019;187:9-16.

Irritability and hyperactivity are common comorbid symptoms in children with ASD and have been linked to lower quality of life, poor adaptive functioning, and lower responsiveness to treatments when compared to children without comorbid problem behaviors. Mazahery et al⁹ evaluated the efficacy of vitamin D, omega-3 long-chain polyunsaturated fatty acids (LCPUFA), or both on irritability and hyperactivity.

Study design

• In a 1-year, double-blind, placebo-controlled trial, 73 children age 2.5 to 8 years with ASD were randomly assigned to receive placebo; vitamin D, 2000 IU/d (VID); omega-3 LCPUFA, 722 mg/d (OM); or both in the aforementioned doses.
• The primary outcome was reduction in the Aberrant Behavior Checklist in the domains of irritability and hyperactivity. Caregivers also completed weekly surveys regarding adverse events, compliance, and utilization of behavioral therapies.
• Of 111 children enrolled, 73 completed the 12 months of treatment.

Outcomes

• Children who received OM and VID had a greater reduction in irritability than those who received placebo (P = .001 and P = .01, respectively).
• Children who received VID also had a reduction in irritability (P = .047).
• An explanatory analysis revealed that OM also reduced lethargy (based on the Aberrant Behavior Checklist) more significantly than placebo (P = .02 adjusted for covariates).

Conclusion

• Treatment with vitamin D, 2000 IU/d, reduced irritability and hyperactivity.
• Treatment with omega-3 LCPUFA, 722 mg/d, reduced hyperactivity and lethargy.

Continue to: Glutamatergic dysregulation has been...

7. Wink LK, Adams R, Horn PS, et al. A randomized placebo-controlled cross-over pilot study of riluzole for drug-refractory irritability in autism spectrum disorder. J Autism Dev Disord. 2018;48(9):3051-3060.

Glutamatergic dysregulation has been identified as a potential cause of ASD. Riluzole, a glutamatergic modulator that is FDA-approved for treating amyotrophic lateral sclerosis, is a drug of interest for the treatment of ASD-related irritability due to this proposed mechanism. Wink et al¹⁰ evaluated riluzole for irritability in patients with ASD.

Study design

• This randomized, double-blind, placebo-controlled, crossover pilot study evaluated the tolerability and safety of adjunctive riluzole treatment for drug-refractory irritability in 8 patients with ASD.
• Participants were age 12 to 25 years, had a diagnosis of ASD confirmed by the autism diagnostic observation schedule 2, and an ABC-I subscale score ≥18. Participants receiving ≥2 psychotropic medications or glutamatergic/GABA-modulating medications were excluded.
• Participants received either 5 weeks of riluzole followed by 5 weeks of placebo, or vice versa; both groups then had a 2-week washout period.
• Riluzole was started at 50 mg/d, and then increased in 50 mg/d–increments to a maximum of 200 mg/d by Week 4.
• Primary outcome measures were change in score on the ABC-I and CGI-I.

Outcomes

• No significant treatment effects were identified.
• All participants tolerated riluzole, 200 mg/d, but increased dosages did not result in a higher overall treatment effect.
• There were no clinically significant adverse effects or laboratory abnormalities.

Conclusion

• Riluzole, 200 mg/d, was well tolerated but had no significant effect on irritability in adolescents with ASD.

Autism spectrum disorder (ASD) is characterized by persistent deficits in social communication and social interaction, including deficits in social reciprocity, nonverbal communicative behaviors used for social interaction, and skills in developing, maintaining, and understanding relationships.¹ In addition, the diagnosis of ASD requires the presence of restricted, repetitive patterns of behavior, interests, or activities.

Initially, ASD was considered a rare condition. In recent years, the reported prevalence has increased substantially. The most recent estimated prevalence is 1 in 68 children at age 8, with a male-to-female ratio of 4 to 1.²

Behavioral interventions are considered to be the most effective treatment for the core symptoms of ASD. Pharmacologic interventions are used primarily to treat associated or comorbid symptoms rather than the core symptoms. Aggression, self-injurious behavior, and irritability are common targets of pharmacotherapy in patients with ASD. Studies have provided support for the use of antipsychotic agents to treat irritability and associated aggressive behaviors in patients with autism,³ but because these agents have significant adverse effects—including extrapyramidal side effects, somnolence, and weight gain—their use requires a careful risk/benefit assessment. Stimulants have also been shown to be effective in treating comorbid attention-deficit/hyperactivity symptoms. The use of selective serotonin reuptake inhibitors (SSRIs) to manage repetitive behaviors and anxiety is also common.

Here, we review 7 recent studies of the pharmacologic management of ASD (Table).^4-10 These studies examined the role of SSRIs (sertraline, fluoxetine), an acetylcholinesterase inhibitor (donepezil), atypical antipsychotics (risperidone, aripiprazole, lurasidone), natural supplements (vitamin D, omega-3), a diuretic (bumetanide), and a glutamatergic modulator (riluzole) in the treatment of ASD symptoms.

1. Potter LA, Scholze DA, Biag HMB, et al. A randomized controlled trial of sertraline in young children with autism spectrum disorder. Front Psychiatry. 2019;10:810.

Several studies have shown that SSRIs improve language development in children with Fragile X syndrome, based on the Mullen Scales of Early Learning (MSEL). A previously published trial involving children with Fragile X syndrome and comorbid ASD found that sertraline improved expressive language development. Potter et al⁴ examined the role of sertraline in children with ASD only.

Study Design

• In this randomized, double-blind, placebo-controlled trial, 58 children age 24 to 72 months with ASD received low-dose sertraline or placebo for 6 months.
• Of the 179 participants who were screened for eligibility, 58 were included in the study. Of these 58 participants, 32 received sertraline and 26 received placebo. The numbers of participants who discontinued from the sertraline and placebo arms were 8 and 5, respectively.
• Among those in the sertraline group, participants age <48 months received 2.5 mg/d, and those age ≥48 months received 5 mg/d.

Outcomes

• No significant differences were found on the primary outcome (MSEL expressive language raw score and age-equivalent combined score) or secondary outcomes (including Clinical Global Impressions–Improvement [CGI-I] scale at 3 months and end of treatment), as per intent-to-treat analyses.
• Sertraline was well tolerated. There was no difference in adverse effects between treatment groups and no serious adverse events.

Conclusion

• Although potentially useful for language development in patients with Fragile X syndrome with comorbid ASD, SSRIs such as sertraline have not proven efficacious for improving expressive language in patients with non-syndromic ASD.
• While 6-month treatment with low-dose sertraline in young children with ASD appears safe, the long-term effects are unknown.

Continue to: Gabis et al⁵ examined the safety...

2. Gabis LV, Ben-Hur R, Shefer S, et al. Improvement of language in children with autism with combined donepezil and choline treatment. J Mol Neurosci. 2019;69(2):224-234.

Gabis et al⁵ examined the safety and efficacy of utilizing donepezil, an acetylcholinesterase inhibitor, plus a choline supplement to treat both core features and associated symptoms in children and adolescents with ASD.

Study design

• This 9-month randomized, double-blind trial included 60 children/adolescents with ASD who were randomly assigned to receive placebo or donepezil plus a choline supplement. Participants underwent a baseline evaluation (E1), 12 weeks of treatment and re-evaluation (E2), 6 months of washout, and a final evaluation (E3).
• The baseline and final evaluations assessed changes in language performance, adaptive functioning, sleep habits, autism severity, clinical impression, and intellectual abilities. The evaluation after 12 weeks of treatment (E2) included all of these measures except intellectual abilities.

Outcomes

• Patients treated with donepezil plus a choline supplement had significant improvement in receptive language skills between E1 and E3 (P = .003).
• Patients treated with donepezil plus a choline supplement had significant worsening in scores on the Autism Treatment Evaluation Checklist (ATEC) health/physical behavior subscale between E1 and E2 (P = .012) and between E1 and E3 (P = .021).
• Improvement in receptive language skills was significant only in patients age 5 to 10 years (P = .047), whereas worsening in ATEC health/physical behavior subscale score was significant only in patients age 10 to 16 years (P = .024).
• Patients treated with donepezil plus a choline supplement reported higher percentages of gastrointestinal disturbance when compared with placebo (P = .007), and patients in the adolescent subgroup had a significant increase in irritability (P = .035).

Conclusion

• Patients age 5 to 10 years treated with donepezil plus a choline supplement exhibited improved receptive language skills. This treatment was less effective in patients age >10 years, and this group also exhibited behavioral worsening.
• Gastrointestinal disturbances were the main adverse effect of treatment with donepezil plus a choline supplement.

Continue to: The persistence of excitatory...

3. James BJ, Gales MA, Gales BJ. Bumetanide for autism spectrum disorder in children: a review of randomized controlled trials. Ann Pharmacother. 2019;53(5):537-544.

The persistence of excitatory gamma-aminobutyric acid (GABA) signaling has been found in patients with ASD. Bumetanide is a sodium-potassium-chloride cotransporter 1 (NKCC1) antagonist that not only decreases intracellular chloride, but also aberrantly decreases GABA signaling. This potent loop diuretic is a proposed treatment for symptoms of ASD. James et al⁶ evaluated the safety and efficacy of bumetanide use in children with ASD.
 

Study design

• Researchers searched the PubMed and Ovid MEDLINE databases for the terms “autism” and “bumetanide” between 1946 and 2018. A total of 26 articles were screened by title, 7 were screened by full text, and 3 articles were included in the study. The remaining articles were excluded due to study design and use of non-human subjects.
• All 3 randomized controlled trials evaluated the effects of low-dose oral bumetanide (most common dose was 0.5 mg twice daily) in a total of 208 patients age 2 to 18 years.
• Measurement scales used in the 3 studies included the Childhood Autism Rating Scale (CARS), Clinical Global Impressions Scale (CGI), Autism Behavioral Checklist (ABC), Social Responsiveness Scale (SRS), and Autism Diagnostic Observation Schedule-Generic (ADOS-G).

Outcomes

• Bumetanide improved scores on multiple autism assessment scales, including CARS, but the degree of improvement was not consistent across the 3 trials.
• There was a statistically significant improvement in ASD symptoms as measured by CGI in all 3 trials, and statistically significant improvements on the ABC and SRS in 2 trials. No improvements were noted on the ADOS-G in any of the trials.
• No dose-effect correlation was identified, but hypokalemia and polyuria were more prevalent with higher doses of bumetanide.

Conclusion

• Low-dose oral bumetanide improved social communication, social interactions, and restricted interests in patients with moderate to severe ASD. However, the 3 trials used different evaluation methods and observed varying degrees of improvement, which makes it difficult to make recommendations for or against the use of bumetanide.
• Streamlined trials with a consensus on evaluation methodology are needed to draw conclusions about the efficacy and safety of bumetanide as a treatment for ASD.

Continue to: The use of SSRIs to target...

4. Li C, Bai Y, Jin C, et al. Efficacy and safety of fluoxetine in autism spectrum disorder: a meta-analysis. Am J Ther. 2020;27(3):e312-e315.

The use of SSRIs to target symptoms of ASD has been long studied because many children with ASD have elevated serotonin levels. Several SSRIs, including fluoxetine, are FDA-approved for the treatment of obsessive-compulsive disorder, anxiety, and depression. Currently, no SSRIs are FDA-approved for treating ASD. In a meta-analysis, Li et al⁷ evaluated the use of fluoxetine for ASD.
 

Study design

• Two independent researchers searched for studies of fluoxetine treatment for ASD in Embase, Google Scholar, Ovid SP, and PubMed, with disagreement resolved by consensus.
• The researchers extracted the study design, patient demographics, and outcomes (inter-rater reliability kappa = 0.93). The primary outcomes were response rate of patients treated with fluoxetine, and change from baseline in ABC, ATEC, CARS, CGI, and Yale-Brown Obsessive Compulsive Scale (Y-BOCS) scores after fluoxetine treatment.

Outcomes

• This meta-analysis included 13 studies in which fluoxetine was used to treat a total of 303 patients with ASD. The median treatment duration was 6 months, the average age of participants was 15.23 years, and most participants (72%) were male.
• The response rate of patients treated with fluoxetine was 75%, with significant mean changes from baseline in ABC score (Helvetica Neue LT Std−3.42), ATEC score (Helvetica Neue LT Std−2.04), CGI score (Helvetica Neue LT Std−0.93), and Y-BOCS score (Helvetica Neue LT Std−1.86).
• A significantly higher incidence of hyperactivity/restlessness/agitation was noted with fluoxetine.

Conclusion

• Although 75% of participants re­sponded to fluoxetine, the limitations of this meta-analysis included low power, inadequate quality of the included studies, and high statistical heterogeneity. In addition, the analysis found a high incidence of hyperactivity/restlessness associated with fluoxetine.
• Future randomized controlled studies may provide further clarification on managing symptoms of ASD with SSRIs.

Continue to: Irritability is a common comorbid...

5. Fallah MS, Shaikh MR, Neupane B, et al. Atypical antipsychotics for irritability in pediatric autism: a systematic review and network meta-analysis. J Child Adolesc Psychopharmacol. 2019;29(3):168-180.

Irritability is a common comorbid symptom in children with ASD. Two second-generation antipsychotics (SGAs)—risperidone and aripiprazole—are FDA-approved for irritability associated with ASD. Fallah et al⁸ examined the efficacy of several SGAs for treating irritability.

Study design

• This review and meta-analysis included 8 studies identified from Medline, PsycINFO, and Embase from inception to March 2018. It included double-blind, randomized controlled trials that used the Aberrant Behavior Checklist Irritability (ABC-I) to measure irritability.
• The main outcome was change in degree of irritability.
• The 8 studies compared the efficacy of risperidone, aripiprazole, lurasidone, and placebo in a total of 878 patients.

Outcomes

• Risperidone reduced ABC-I scores more than aripiprazole, lurasidone, or placebo.
• Mean differences in ABC-I scores were Helvetica Neue LT Std−6.89 for risperidone, Helvetica Neue LT Std−6.62 for aripiprazole, and Helvetica Neue LT Std−1.61 for lurasidone.

Conclusion

• Risperidone and aripiprazole were efficacious and safe for children with ASD-associated irritability.
• Lurasidone may minimally improve irritability in children with ASD.

Continue to: Irritability and hyperactivity are common...

6. Mazahery H, Conlon CA, Beck KL, et al. A randomised controlled trial of vitamin D and omega-3 long chain polyunsaturated fatty acids in the treatment of irritability and hyperactivity among children with autism spectrum disorder. J Steroid Biochem Mol Biol. 2019;187:9-16.

Irritability and hyperactivity are common comorbid symptoms in children with ASD and have been linked to lower quality of life, poor adaptive functioning, and lower responsiveness to treatments when compared to children without comorbid problem behaviors. Mazahery et al⁹ evaluated the efficacy of vitamin D, omega-3 long-chain polyunsaturated fatty acids (LCPUFA), or both on irritability and hyperactivity.

Study design

• In a 1-year, double-blind, placebo-controlled trial, 73 children age 2.5 to 8 years with ASD were randomly assigned to receive placebo; vitamin D, 2000 IU/d (VID); omega-3 LCPUFA, 722 mg/d (OM); or both in the aforementioned doses.
• The primary outcome was reduction in the Aberrant Behavior Checklist in the domains of irritability and hyperactivity. Caregivers also completed weekly surveys regarding adverse events, compliance, and utilization of behavioral therapies.
• Of 111 children enrolled, 73 completed the 12 months of treatment.

Outcomes

• Children who received OM and VID had a greater reduction in irritability than those who received placebo (P = .001 and P = .01, respectively).
• Children who received VID also had a reduction in irritability (P = .047).
• An explanatory analysis revealed that OM also reduced lethargy (based on the Aberrant Behavior Checklist) more significantly than placebo (P = .02 adjusted for covariates).

Conclusion

• Treatment with vitamin D, 2000 IU/d, reduced irritability and hyperactivity.
• Treatment with omega-3 LCPUFA, 722 mg/d, reduced hyperactivity and lethargy.

Continue to: Glutamatergic dysregulation has been...

7. Wink LK, Adams R, Horn PS, et al. A randomized placebo-controlled cross-over pilot study of riluzole for drug-refractory irritability in autism spectrum disorder. J Autism Dev Disord. 2018;48(9):3051-3060.

Glutamatergic dysregulation has been identified as a potential cause of ASD. Riluzole, a glutamatergic modulator that is FDA-approved for treating amyotrophic lateral sclerosis, is a drug of interest for the treatment of ASD-related irritability due to this proposed mechanism. Wink et al¹⁰ evaluated riluzole for irritability in patients with ASD.

Study design

• This randomized, double-blind, placebo-controlled, crossover pilot study evaluated the tolerability and safety of adjunctive riluzole treatment for drug-refractory irritability in 8 patients with ASD.
• Participants were age 12 to 25 years, had a diagnosis of ASD confirmed by the autism diagnostic observation schedule 2, and an ABC-I subscale score ≥18. Participants receiving ≥2 psychotropic medications or glutamatergic/GABA-modulating medications were excluded.
• Participants received either 5 weeks of riluzole followed by 5 weeks of placebo, or vice versa; both groups then had a 2-week washout period.
• Riluzole was started at 50 mg/d, and then increased in 50 mg/d–increments to a maximum of 200 mg/d by Week 4.
• Primary outcome measures were change in score on the ABC-I and CGI-I.

Outcomes

• No significant treatment effects were identified.
• All participants tolerated riluzole, 200 mg/d, but increased dosages did not result in a higher overall treatment effect.
• There were no clinically significant adverse effects or laboratory abnormalities.

Conclusion

• Riluzole, 200 mg/d, was well tolerated but had no significant effect on irritability in adolescents with ASD.

Widespread use of the MMR vaccine is not only crucial for protecting the community against infectious outbreaks, but also serves as the overall pacesetter for preventive services, said Sara M. Bode, MD and colleagues at Nationwide Children’s Hospital in Columbus.

CDC/Molly Kurnit, M.P.H.

As part of a bivariate logistic regression analysis, Dr. Bode and colleagues sought to evaluate changes in measles vaccination rates across 12 clinic sites of the Nationwide Children’s Hospital pediatric primary care network in Columbus among 23,534 children aged 16 months. The study period targeted the time between April and May 2020, when clinic access and appointment attendance declined following the start of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, until the June-to-August 2020 time period, when clinical care was allowed to return.

The need for the study was prompted by Centers for Disease Control and Prevention reporting on a state-specific precipitous decline in MMR vaccination rates shortly after the onset of COVID-19 in May 2020. Citing the results of one study, such reductions in vaccination have raised concerns over the possibility of a measles resurgence, noted Dr. Bode and associates.
 

MMR vaccination rates begin to drop with onset of COVID-19 pandemic.

From March 2017 to March 2020, the average rate of MMR vaccination in 16-month-olds was 72%. It subsequently decreased to 67% from April to May 2020, and then dropped further to 62% during the period June to August, 2020 (P = .001). Those without insurance were less likely to be vaccinated than were those carrying private insurance or Medicaid. Hispanic and Asian Americans were more likely than were White and Black patients (85% and 90% vs. 69% and 67%, respectively) to have been vaccinated.

Among patients who had not attended a preventive care visit after 12 months of age, the proportion who received vaccines declined during the same time periods, from 10% before the pandemic to 6% at the start of the pandemic and 3% during the summer months of 2020.

“Given the baseline low vaccination rates even before the pandemic and the subsequent decline, we face a critical need to improve timely vaccination and provide catch-up opportunities” in areas with the highest incidence of COVID-19, observed Dr. Bode and colleagues.

Innovative approaches are needed to encourage families to seek preventive care.

In response, the researchers announced the implementation of new community-based vaccination approaches in Ohio, including pop-up vaccine clinics, mobile clinics, and school-based clinics to provide families, who are reluctant to visit health care facilities over COVID-19 related concerns, with safe alternatives. “We believe that it is critical to develop innovative approaches to have families return for preventive care,” they added.

In a separate interview, Herschel Lessin, MD, a private practice pediatrician in Poughkeepsie, N.Y., noted: “This study confirms the anecdotal experience of pediatricians around the country, and our greatest fear that the pandemic will interfere with herd immunity of children for vaccine-preventable illness. Although the study was of urban offices with a primarily Medicaid population, I believe the results to be very worrisome should they prove to be generalizable to the country, as a whole. The significant reduction of well-child visits due to COVID-19 (and fear of COVID-19) seriously impaired the vaccination status of a standard required vaccine in a large population. What is even more worrisome is that the rates continued to fall even after the initial closure of many offices and well into their reopening, despite concerted efforts to try to catch up these missed visits and immunizations.”

Measles is an intensely contagious illness that has not been eradicated, as evidenced by the enormous measles outbreak stemming from Disneyland in 2014-2015, and again with the possible exposure of hundreds to an infected Disneyland visitor last fall, where coverage rates were even higher than in this study, added Dr. Lessin. “This phenomenon, unless forcefully remedied, could easily result in large outbreaks of other vaccine-preventable illness besides COVID-19,” he cautioned.

Dr. Bode and colleagues as well as Dr. Lessin had no conflicts of interest and no relevant financial disclosures.

SOURCE: Bode SM et al. Pediatrics. 2021. doi: 10.1542/peds.2020-035576.

Widespread use of the MMR vaccine is not only crucial for protecting the community against infectious outbreaks, but also serves as the overall pacesetter for preventive services, said Sara M. Bode, MD and colleagues at Nationwide Children’s Hospital in Columbus.

CDC/Molly Kurnit, M.P.H.

As part of a bivariate logistic regression analysis, Dr. Bode and colleagues sought to evaluate changes in measles vaccination rates across 12 clinic sites of the Nationwide Children’s Hospital pediatric primary care network in Columbus among 23,534 children aged 16 months. The study period targeted the time between April and May 2020, when clinic access and appointment attendance declined following the start of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, until the June-to-August 2020 time period, when clinical care was allowed to return.

The need for the study was prompted by Centers for Disease Control and Prevention reporting on a state-specific precipitous decline in MMR vaccination rates shortly after the onset of COVID-19 in May 2020. Citing the results of one study, such reductions in vaccination have raised concerns over the possibility of a measles resurgence, noted Dr. Bode and associates.
 

MMR vaccination rates begin to drop with onset of COVID-19 pandemic.

From March 2017 to March 2020, the average rate of MMR vaccination in 16-month-olds was 72%. It subsequently decreased to 67% from April to May 2020, and then dropped further to 62% during the period June to August, 2020 (P = .001). Those without insurance were less likely to be vaccinated than were those carrying private insurance or Medicaid. Hispanic and Asian Americans were more likely than were White and Black patients (85% and 90% vs. 69% and 67%, respectively) to have been vaccinated.

Among patients who had not attended a preventive care visit after 12 months of age, the proportion who received vaccines declined during the same time periods, from 10% before the pandemic to 6% at the start of the pandemic and 3% during the summer months of 2020.

“Given the baseline low vaccination rates even before the pandemic and the subsequent decline, we face a critical need to improve timely vaccination and provide catch-up opportunities” in areas with the highest incidence of COVID-19, observed Dr. Bode and colleagues.

Innovative approaches are needed to encourage families to seek preventive care.

In response, the researchers announced the implementation of new community-based vaccination approaches in Ohio, including pop-up vaccine clinics, mobile clinics, and school-based clinics to provide families, who are reluctant to visit health care facilities over COVID-19 related concerns, with safe alternatives. “We believe that it is critical to develop innovative approaches to have families return for preventive care,” they added.

In a separate interview, Herschel Lessin, MD, a private practice pediatrician in Poughkeepsie, N.Y., noted: “This study confirms the anecdotal experience of pediatricians around the country, and our greatest fear that the pandemic will interfere with herd immunity of children for vaccine-preventable illness. Although the study was of urban offices with a primarily Medicaid population, I believe the results to be very worrisome should they prove to be generalizable to the country, as a whole. The significant reduction of well-child visits due to COVID-19 (and fear of COVID-19) seriously impaired the vaccination status of a standard required vaccine in a large population. What is even more worrisome is that the rates continued to fall even after the initial closure of many offices and well into their reopening, despite concerted efforts to try to catch up these missed visits and immunizations.”

Measles is an intensely contagious illness that has not been eradicated, as evidenced by the enormous measles outbreak stemming from Disneyland in 2014-2015, and again with the possible exposure of hundreds to an infected Disneyland visitor last fall, where coverage rates were even higher than in this study, added Dr. Lessin. “This phenomenon, unless forcefully remedied, could easily result in large outbreaks of other vaccine-preventable illness besides COVID-19,” he cautioned.

Dr. Bode and colleagues as well as Dr. Lessin had no conflicts of interest and no relevant financial disclosures.

SOURCE: Bode SM et al. Pediatrics. 2021. doi: 10.1542/peds.2020-035576.

Widespread use of the MMR vaccine is not only crucial for protecting the community against infectious outbreaks, but also serves as the overall pacesetter for preventive services, said Sara M. Bode, MD and colleagues at Nationwide Children’s Hospital in Columbus.

CDC/Molly Kurnit, M.P.H.

As part of a bivariate logistic regression analysis, Dr. Bode and colleagues sought to evaluate changes in measles vaccination rates across 12 clinic sites of the Nationwide Children’s Hospital pediatric primary care network in Columbus among 23,534 children aged 16 months. The study period targeted the time between April and May 2020, when clinic access and appointment attendance declined following the start of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic, until the June-to-August 2020 time period, when clinical care was allowed to return.

The need for the study was prompted by Centers for Disease Control and Prevention reporting on a state-specific precipitous decline in MMR vaccination rates shortly after the onset of COVID-19 in May 2020. Citing the results of one study, such reductions in vaccination have raised concerns over the possibility of a measles resurgence, noted Dr. Bode and associates.
 

MMR vaccination rates begin to drop with onset of COVID-19 pandemic.

From March 2017 to March 2020, the average rate of MMR vaccination in 16-month-olds was 72%. It subsequently decreased to 67% from April to May 2020, and then dropped further to 62% during the period June to August, 2020 (P = .001). Those without insurance were less likely to be vaccinated than were those carrying private insurance or Medicaid. Hispanic and Asian Americans were more likely than were White and Black patients (85% and 90% vs. 69% and 67%, respectively) to have been vaccinated.

Among patients who had not attended a preventive care visit after 12 months of age, the proportion who received vaccines declined during the same time periods, from 10% before the pandemic to 6% at the start of the pandemic and 3% during the summer months of 2020.

“Given the baseline low vaccination rates even before the pandemic and the subsequent decline, we face a critical need to improve timely vaccination and provide catch-up opportunities” in areas with the highest incidence of COVID-19, observed Dr. Bode and colleagues.

Innovative approaches are needed to encourage families to seek preventive care.

In response, the researchers announced the implementation of new community-based vaccination approaches in Ohio, including pop-up vaccine clinics, mobile clinics, and school-based clinics to provide families, who are reluctant to visit health care facilities over COVID-19 related concerns, with safe alternatives. “We believe that it is critical to develop innovative approaches to have families return for preventive care,” they added.

In a separate interview, Herschel Lessin, MD, a private practice pediatrician in Poughkeepsie, N.Y., noted: “This study confirms the anecdotal experience of pediatricians around the country, and our greatest fear that the pandemic will interfere with herd immunity of children for vaccine-preventable illness. Although the study was of urban offices with a primarily Medicaid population, I believe the results to be very worrisome should they prove to be generalizable to the country, as a whole. The significant reduction of well-child visits due to COVID-19 (and fear of COVID-19) seriously impaired the vaccination status of a standard required vaccine in a large population. What is even more worrisome is that the rates continued to fall even after the initial closure of many offices and well into their reopening, despite concerted efforts to try to catch up these missed visits and immunizations.”

Measles is an intensely contagious illness that has not been eradicated, as evidenced by the enormous measles outbreak stemming from Disneyland in 2014-2015, and again with the possible exposure of hundreds to an infected Disneyland visitor last fall, where coverage rates were even higher than in this study, added Dr. Lessin. “This phenomenon, unless forcefully remedied, could easily result in large outbreaks of other vaccine-preventable illness besides COVID-19,” he cautioned.

Dr. Bode and colleagues as well as Dr. Lessin had no conflicts of interest and no relevant financial disclosures.

SOURCE: Bode SM et al. Pediatrics. 2021. doi: 10.1542/peds.2020-035576.

For the seventh week out of the last eight, more new cases of COVID-19 in children were reported in the United States than any week before, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

There were just over 182,000 new cases of COVID-19 in children during the week ending Dec. 17, topping the previous high of almost 179,000 set the previous week. That difference of about 3,000 cases, however, is the smallest weekly increase since Oct. 1 – a stretch of 11 weeks that has produced only one decline, based on data from the latest AAP/CHA weekly report.

As of Dec. 17, there had been over 1.8 million cases of COVID-19 in children, which represents 12.3% of all U.S. cases. For the week, 14% of all cases occurred in children, which was up slightly from 13.8% the week before (Dec. 10). The overall rate of coronavirus infection is now 2,420 cases per 100,000 children in the population, the AAP and CHA said.

A total of 30 states are above that national rate, with North Dakota the highest at 7,515 cases per 100,000 children, followed by South Dakota (5,618), Wyoming (5,157), Wisconsin (5,106), and Tennessee (4,994). Wyoming has the highest proportion of cases occurring in children at 20.8%, but that is down from 23.4% in mid-November, based on data collected by the AAP and CHA from the health department websites of 49 states (New York does not provide age distributions), the District of Columbia, New York City, Puerto Rico, and Guam.

In the last 2 weeks, however, the largest percent increases in new cases came in states with low-to-average rates of cumulative child infection. California, Connecticut, Delaware, Maine, Maryland, New Hampshire, and Vermont all saw increases of over 35% from Dec. 3 to Dec. 17, while the smallest increases occurred in Hawaii, North Dakota, and Wyoming, the AAP and CHA reported.

[email protected]

For the seventh week out of the last eight, more new cases of COVID-19 in children were reported in the United States than any week before, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

There were just over 182,000 new cases of COVID-19 in children during the week ending Dec. 17, topping the previous high of almost 179,000 set the previous week. That difference of about 3,000 cases, however, is the smallest weekly increase since Oct. 1 – a stretch of 11 weeks that has produced only one decline, based on data from the latest AAP/CHA weekly report.

As of Dec. 17, there had been over 1.8 million cases of COVID-19 in children, which represents 12.3% of all U.S. cases. For the week, 14% of all cases occurred in children, which was up slightly from 13.8% the week before (Dec. 10). The overall rate of coronavirus infection is now 2,420 cases per 100,000 children in the population, the AAP and CHA said.

A total of 30 states are above that national rate, with North Dakota the highest at 7,515 cases per 100,000 children, followed by South Dakota (5,618), Wyoming (5,157), Wisconsin (5,106), and Tennessee (4,994). Wyoming has the highest proportion of cases occurring in children at 20.8%, but that is down from 23.4% in mid-November, based on data collected by the AAP and CHA from the health department websites of 49 states (New York does not provide age distributions), the District of Columbia, New York City, Puerto Rico, and Guam.

In the last 2 weeks, however, the largest percent increases in new cases came in states with low-to-average rates of cumulative child infection. California, Connecticut, Delaware, Maine, Maryland, New Hampshire, and Vermont all saw increases of over 35% from Dec. 3 to Dec. 17, while the smallest increases occurred in Hawaii, North Dakota, and Wyoming, the AAP and CHA reported.

[email protected]

For the seventh week out of the last eight, more new cases of COVID-19 in children were reported in the United States than any week before, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

There were just over 182,000 new cases of COVID-19 in children during the week ending Dec. 17, topping the previous high of almost 179,000 set the previous week. That difference of about 3,000 cases, however, is the smallest weekly increase since Oct. 1 – a stretch of 11 weeks that has produced only one decline, based on data from the latest AAP/CHA weekly report.

As of Dec. 17, there had been over 1.8 million cases of COVID-19 in children, which represents 12.3% of all U.S. cases. For the week, 14% of all cases occurred in children, which was up slightly from 13.8% the week before (Dec. 10). The overall rate of coronavirus infection is now 2,420 cases per 100,000 children in the population, the AAP and CHA said.

A total of 30 states are above that national rate, with North Dakota the highest at 7,515 cases per 100,000 children, followed by South Dakota (5,618), Wyoming (5,157), Wisconsin (5,106), and Tennessee (4,994). Wyoming has the highest proportion of cases occurring in children at 20.8%, but that is down from 23.4% in mid-November, based on data collected by the AAP and CHA from the health department websites of 49 states (New York does not provide age distributions), the District of Columbia, New York City, Puerto Rico, and Guam.

In the last 2 weeks, however, the largest percent increases in new cases came in states with low-to-average rates of cumulative child infection. California, Connecticut, Delaware, Maine, Maryland, New Hampshire, and Vermont all saw increases of over 35% from Dec. 3 to Dec. 17, while the smallest increases occurred in Hawaii, North Dakota, and Wyoming, the AAP and CHA reported.

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The majority of video content related to acne on the mobile app TikTok was presented by nonphysicians and had serious shortcomings, according to an analysis of the top 100 videos using a consumer health validation tool.

The popularity of TikTok among adolescents in particular has implications for the dissemination of acne information, as some teens become “skinfluencers” and receive sponsorship from skin care brands in exchange for social media promotion, wrote David X. Zheng, BA, of the department of dermatology, Case Western Reserve University, Cleveland, and colleagues.

“However, the quality of dermatologic information found on TikTok is largely unknown,” they said.

In a brief report published in Pediatric Dermatology, the researchers identified the top 100 videos on TikTok on May 1, 2020, that were tagged with “#acne.” The information on each video included date of upload, type and gender of the individual uploading the video, physician specialty if applicable, and video category. These top 100 videos had 13,470,501 likes and 64,775 comments over a 7.6-month time period.

The researchers used the DISCERN criteria, a validated 1-5 scale designed to assess consumer health information, to evaluate the video content, with 1 (having “serious” or “extensive shortcomings”) and 5 (having “minimal shortcomings.”)

Overall, the average quality rating of the TikTok acne videos was 2.03. A total of 9 videos were produced by board-certified physicians in the United States, with an average DISCERN score of 2.41.

“Analysis of the DISCERN criteria dimensions suggested that major shortcomings common to both physician and nonphysician uploaders included failure to cite information sources, discuss treatment risks, and provide support for shared decision-making,” the researchers said.

Approximately one-third (34%) of the videos fell into the treatment-product advertisement category, while 26% were personal anecdotes, 20% presented information related to acne, 13% featured home remedy treatments, and 7% were classified as “other.” The researchers also identified the top 200 “#acne” videos on TikTok once a week from May 8, 2020 to June 5, 2020, to determine the evolution of acne content on the app and found a turnover rate of 10.9% per week.

Based on the high turnover and low quality based on DISCERN ratings, the authors suggested that patients seeking acne information should “view acne-related TikTok videos with caution and consult evidence-based resources whenever possible.”

The study findings were limited by several factors including the small sample size of physicians uploading videos, lack of information about the number of nonphysician medical professionals who uploaded videos, and lack of information about the number of video views and country of origin, the researchers noted. However, the results highlight the need for dermatologists to be aware that patients, especially teens, may be using TikTok for acne information that may be of poor quality, they said.

“Conversely, we understand that social media can be a powerful tool for advancing health literacy,” the researchers noted. “Therefore, we also recommend that health care professionals engaging on TikTok create thorough and perhaps standardized educational videos regarding acne, as well as correct any acne-related misinformation that may be present,” they concluded.

The other authors of the study were from the departments of dermatology at Case Western Reserve, University Hospitals Cleveland, and Johns Hopkins University, Baltimore.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Zheng DX et al. Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14471.

The majority of video content related to acne on the mobile app TikTok was presented by nonphysicians and had serious shortcomings, according to an analysis of the top 100 videos using a consumer health validation tool.

The popularity of TikTok among adolescents in particular has implications for the dissemination of acne information, as some teens become “skinfluencers” and receive sponsorship from skin care brands in exchange for social media promotion, wrote David X. Zheng, BA, of the department of dermatology, Case Western Reserve University, Cleveland, and colleagues.

“However, the quality of dermatologic information found on TikTok is largely unknown,” they said.

In a brief report published in Pediatric Dermatology, the researchers identified the top 100 videos on TikTok on May 1, 2020, that were tagged with “#acne.” The information on each video included date of upload, type and gender of the individual uploading the video, physician specialty if applicable, and video category. These top 100 videos had 13,470,501 likes and 64,775 comments over a 7.6-month time period.

The researchers used the DISCERN criteria, a validated 1-5 scale designed to assess consumer health information, to evaluate the video content, with 1 (having “serious” or “extensive shortcomings”) and 5 (having “minimal shortcomings.”)

Overall, the average quality rating of the TikTok acne videos was 2.03. A total of 9 videos were produced by board-certified physicians in the United States, with an average DISCERN score of 2.41.

“Analysis of the DISCERN criteria dimensions suggested that major shortcomings common to both physician and nonphysician uploaders included failure to cite information sources, discuss treatment risks, and provide support for shared decision-making,” the researchers said.

Approximately one-third (34%) of the videos fell into the treatment-product advertisement category, while 26% were personal anecdotes, 20% presented information related to acne, 13% featured home remedy treatments, and 7% were classified as “other.” The researchers also identified the top 200 “#acne” videos on TikTok once a week from May 8, 2020 to June 5, 2020, to determine the evolution of acne content on the app and found a turnover rate of 10.9% per week.

Based on the high turnover and low quality based on DISCERN ratings, the authors suggested that patients seeking acne information should “view acne-related TikTok videos with caution and consult evidence-based resources whenever possible.”

The study findings were limited by several factors including the small sample size of physicians uploading videos, lack of information about the number of nonphysician medical professionals who uploaded videos, and lack of information about the number of video views and country of origin, the researchers noted. However, the results highlight the need for dermatologists to be aware that patients, especially teens, may be using TikTok for acne information that may be of poor quality, they said.

“Conversely, we understand that social media can be a powerful tool for advancing health literacy,” the researchers noted. “Therefore, we also recommend that health care professionals engaging on TikTok create thorough and perhaps standardized educational videos regarding acne, as well as correct any acne-related misinformation that may be present,” they concluded.

The other authors of the study were from the departments of dermatology at Case Western Reserve, University Hospitals Cleveland, and Johns Hopkins University, Baltimore.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Zheng DX et al. Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14471.

The majority of video content related to acne on the mobile app TikTok was presented by nonphysicians and had serious shortcomings, according to an analysis of the top 100 videos using a consumer health validation tool.

The popularity of TikTok among adolescents in particular has implications for the dissemination of acne information, as some teens become “skinfluencers” and receive sponsorship from skin care brands in exchange for social media promotion, wrote David X. Zheng, BA, of the department of dermatology, Case Western Reserve University, Cleveland, and colleagues.

“However, the quality of dermatologic information found on TikTok is largely unknown,” they said.

In a brief report published in Pediatric Dermatology, the researchers identified the top 100 videos on TikTok on May 1, 2020, that were tagged with “#acne.” The information on each video included date of upload, type and gender of the individual uploading the video, physician specialty if applicable, and video category. These top 100 videos had 13,470,501 likes and 64,775 comments over a 7.6-month time period.

The researchers used the DISCERN criteria, a validated 1-5 scale designed to assess consumer health information, to evaluate the video content, with 1 (having “serious” or “extensive shortcomings”) and 5 (having “minimal shortcomings.”)

Overall, the average quality rating of the TikTok acne videos was 2.03. A total of 9 videos were produced by board-certified physicians in the United States, with an average DISCERN score of 2.41.

“Analysis of the DISCERN criteria dimensions suggested that major shortcomings common to both physician and nonphysician uploaders included failure to cite information sources, discuss treatment risks, and provide support for shared decision-making,” the researchers said.

Approximately one-third (34%) of the videos fell into the treatment-product advertisement category, while 26% were personal anecdotes, 20% presented information related to acne, 13% featured home remedy treatments, and 7% were classified as “other.” The researchers also identified the top 200 “#acne” videos on TikTok once a week from May 8, 2020 to June 5, 2020, to determine the evolution of acne content on the app and found a turnover rate of 10.9% per week.

Based on the high turnover and low quality based on DISCERN ratings, the authors suggested that patients seeking acne information should “view acne-related TikTok videos with caution and consult evidence-based resources whenever possible.”

The study findings were limited by several factors including the small sample size of physicians uploading videos, lack of information about the number of nonphysician medical professionals who uploaded videos, and lack of information about the number of video views and country of origin, the researchers noted. However, the results highlight the need for dermatologists to be aware that patients, especially teens, may be using TikTok for acne information that may be of poor quality, they said.

“Conversely, we understand that social media can be a powerful tool for advancing health literacy,” the researchers noted. “Therefore, we also recommend that health care professionals engaging on TikTok create thorough and perhaps standardized educational videos regarding acne, as well as correct any acne-related misinformation that may be present,” they concluded.

The other authors of the study were from the departments of dermatology at Case Western Reserve, University Hospitals Cleveland, and Johns Hopkins University, Baltimore.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Zheng DX et al. Pediatr Dermatol. 2020 Nov 28. doi: 10.1111/pde.14471.