Pediatrics

From movies to billboards to magazine covers – media have been pushing impossible beauty ideals for decades. But the recent rise of social media brings that exposure to new levels, particularly for young people.

“Youth spend, on average, between 6 and 8 hours per day on screens, much of it on social media,” said senior study author Gary S. Goldfield, PhD, senior scientist at Children’s Hospital of Eastern Ontario Research Institute in Ottawa, Canada. “Social media provides exposure to so many photo-edited pictures – including those of models, celebrities, and fitness instructors – that perpetuate an unattainable beauty standard that gets internalized by impressionable youth and young adults, leading to body dissatisfaction.”

Plenty of research has linked frequent social media use with body image issues and even eating disorders. But crucial gaps in our knowledge remain, Dr. Goldfield said.

Much of that research “is correlational,” Dr. Goldfield added. And studies don’t always focus on individuals who may be more vulnerable to social media’s harmful effects, such as those with ruminative or brooding cognitive styles, affecting results.

And none have explored an obvious question: Can cutting down on social media use also diminish its potential harms?

Dr. Goldfield and his colleagues found an answer: Yes, it can.  

Limiting social media use to 1 hour per day helped older teens and young adults feel much better about their weight and appearance after only 3 weeks, according to the study in Psychology of Popular Media, a journal of the American Psychological Association.

“Our randomized controlled design allowed us to show a stronger causal link between social media use and body image in youth, compared to previous research,” Dr. Goldfield said. “To our knowledge, this is the first study to show that social media use reduction leads to enhanced body image.”

Nancy Lee Zucker, PhD, professor of psychology and neuroscience at Duke University, Durham, N.C., and director of the Duke Center for Eating Disorders, said the results provide needed data that could help guide young people and parents on optimal social media use. Dr. Zucker was not involved in the study.
 

What the researchers did

For the study, Dr. Goldfield and colleagues recruited undergraduate psychology students aged 17-25 who averaged at least 2 hours per day of social media use on smartphones, and who had symptoms of depression or anxiety.

Participants were not told the purpose of the study, and their social media use was monitored by a screen time tracking program. At the beginning and end of the study, they answered questions such as “I’m pretty happy about the way I look,” and “I am satisfied with my weight,” on a 1 (never) to 5 (always) Likert scale.

During the first week, all 220 participants (76% female, 23% male, and 1% other) were told to use social media on their smartphones as they usually do. Over the next 3 weeks, 117 students were told to limit their social media use to 1 hour per day, while the rest were instructed to carry on as usual. In both groups, over 70% of participants were between age 17 and 19. 

The first group cut their social media use by about 50%, from a mean of around 168 minutes per day during week 1 to around 78 minutes per day by the end of week 4, while the unrestricted group went from around 181 minutes per day to 189.
 

Cutting use by around half yielded quick, significant improvements

The students who curbed their social media use saw significant improvements in their “appearance esteem” (from 2.95 to 3.15 points; P <.001) and their “weight esteem” (from 3.16 to 3.32 points; P < .001), whereas those who used social media freely saw no such changes (from 2.72 to 2.76; P = .992 and 3.01 to 3.02; P = .654, respectively). No gender differences between the groups were found.

The researchers are now studying possible reasons for these findings.

The changes in appearance scores “represent a small- to medium-effect size,” said child psychologist Sara R. Gould, PhD, director of the Eating Disorders Center at Children’s Mercy Kansas City in Missouri, who was not associated with the research.“ As such, these are clinically meaningful results, particularly since they were achieved in only 3 weeks. Even small impacts can be added to other changes to create larger impacts or have the potential to grow over time.”
 

The push to limit social media

As more and more experts scrutinize the impact of social media on young people’s mental health, social media companies have responded with features designed to limit the time young users spend on their platforms.

Just this year, Instagram rolled out “quiet mode,” which lets users shut down their direct messages (DMs) for a specified amount of time. To turn on quiet mode, users can navigate to their profiles, and select the triple line icon, “settings,” “notifications,” and “quiet mode.” Another option: Tap the triple line icon, “your activity,” and “time spent” to set reminders to take breaks after 10, 20, or 30 minutes of use.  

TikTok users under 18 will soon have their accounts defaulted to a 1-hour daily screen-time limit, TikTok has announced. Unlike other similar features, it will require users to turn it off rather than turn it on.

Leveraging built-in controls is “a good start to being more intentional about your screen time,” suggested lead author Helen Thai, a PhD student in clinical psychology at McGill University in Montreal. “Unfortunately, users can easily bypass these settings.”  

One reason for social’s magnetic pull: “FOMO – fear of missing out – on what friends are doing can make cutting back on social media use difficult,” said Dr. Zucker. To help prevent FOMO, parents may consider talking to parents of their children’s friends about reducing usage for all the children, Dr. Zucker suggested.

Mary E. Romano, MD, MPH, associate professor of pediatrics-adolescent medicine at Vanderbilt University, Nashville, Tenn., urges parents “to have very clear rules and expectations about social media use.” 

Dr. Romano, also not involved in the study, recommended the website Wait Until 8th to help parents band together to commit to delaying smartphone access until at least eighth grade.

Dr. Gould recommended the Family Media Plan, a tool from the American Academy of Pediatrics that lets users create a customized plan, complete with guidance tailored to each person’s age and the family’s goals. Sample tips: Designate a basket for holding devices during meals, and switch to audiobooks or relaxing music instead of videos to fall asleep at night.
 

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

From movies to billboards to magazine covers – media have been pushing impossible beauty ideals for decades. But the recent rise of social media brings that exposure to new levels, particularly for young people.

“Youth spend, on average, between 6 and 8 hours per day on screens, much of it on social media,” said senior study author Gary S. Goldfield, PhD, senior scientist at Children’s Hospital of Eastern Ontario Research Institute in Ottawa, Canada. “Social media provides exposure to so many photo-edited pictures – including those of models, celebrities, and fitness instructors – that perpetuate an unattainable beauty standard that gets internalized by impressionable youth and young adults, leading to body dissatisfaction.”

Plenty of research has linked frequent social media use with body image issues and even eating disorders. But crucial gaps in our knowledge remain, Dr. Goldfield said.

Much of that research “is correlational,” Dr. Goldfield added. And studies don’t always focus on individuals who may be more vulnerable to social media’s harmful effects, such as those with ruminative or brooding cognitive styles, affecting results.

And none have explored an obvious question: Can cutting down on social media use also diminish its potential harms?

Dr. Goldfield and his colleagues found an answer: Yes, it can.  

Limiting social media use to 1 hour per day helped older teens and young adults feel much better about their weight and appearance after only 3 weeks, according to the study in Psychology of Popular Media, a journal of the American Psychological Association.

“Our randomized controlled design allowed us to show a stronger causal link between social media use and body image in youth, compared to previous research,” Dr. Goldfield said. “To our knowledge, this is the first study to show that social media use reduction leads to enhanced body image.”

Nancy Lee Zucker, PhD, professor of psychology and neuroscience at Duke University, Durham, N.C., and director of the Duke Center for Eating Disorders, said the results provide needed data that could help guide young people and parents on optimal social media use. Dr. Zucker was not involved in the study.
 

What the researchers did

For the study, Dr. Goldfield and colleagues recruited undergraduate psychology students aged 17-25 who averaged at least 2 hours per day of social media use on smartphones, and who had symptoms of depression or anxiety.

Participants were not told the purpose of the study, and their social media use was monitored by a screen time tracking program. At the beginning and end of the study, they answered questions such as “I’m pretty happy about the way I look,” and “I am satisfied with my weight,” on a 1 (never) to 5 (always) Likert scale.

During the first week, all 220 participants (76% female, 23% male, and 1% other) were told to use social media on their smartphones as they usually do. Over the next 3 weeks, 117 students were told to limit their social media use to 1 hour per day, while the rest were instructed to carry on as usual. In both groups, over 70% of participants were between age 17 and 19. 

The first group cut their social media use by about 50%, from a mean of around 168 minutes per day during week 1 to around 78 minutes per day by the end of week 4, while the unrestricted group went from around 181 minutes per day to 189.
 

Cutting use by around half yielded quick, significant improvements

The students who curbed their social media use saw significant improvements in their “appearance esteem” (from 2.95 to 3.15 points; P <.001) and their “weight esteem” (from 3.16 to 3.32 points; P < .001), whereas those who used social media freely saw no such changes (from 2.72 to 2.76; P = .992 and 3.01 to 3.02; P = .654, respectively). No gender differences between the groups were found.

The researchers are now studying possible reasons for these findings.

The changes in appearance scores “represent a small- to medium-effect size,” said child psychologist Sara R. Gould, PhD, director of the Eating Disorders Center at Children’s Mercy Kansas City in Missouri, who was not associated with the research.“ As such, these are clinically meaningful results, particularly since they were achieved in only 3 weeks. Even small impacts can be added to other changes to create larger impacts or have the potential to grow over time.”
 

The push to limit social media

As more and more experts scrutinize the impact of social media on young people’s mental health, social media companies have responded with features designed to limit the time young users spend on their platforms.

Just this year, Instagram rolled out “quiet mode,” which lets users shut down their direct messages (DMs) for a specified amount of time. To turn on quiet mode, users can navigate to their profiles, and select the triple line icon, “settings,” “notifications,” and “quiet mode.” Another option: Tap the triple line icon, “your activity,” and “time spent” to set reminders to take breaks after 10, 20, or 30 minutes of use.  

TikTok users under 18 will soon have their accounts defaulted to a 1-hour daily screen-time limit, TikTok has announced. Unlike other similar features, it will require users to turn it off rather than turn it on.

Leveraging built-in controls is “a good start to being more intentional about your screen time,” suggested lead author Helen Thai, a PhD student in clinical psychology at McGill University in Montreal. “Unfortunately, users can easily bypass these settings.”  

One reason for social’s magnetic pull: “FOMO – fear of missing out – on what friends are doing can make cutting back on social media use difficult,” said Dr. Zucker. To help prevent FOMO, parents may consider talking to parents of their children’s friends about reducing usage for all the children, Dr. Zucker suggested.

Mary E. Romano, MD, MPH, associate professor of pediatrics-adolescent medicine at Vanderbilt University, Nashville, Tenn., urges parents “to have very clear rules and expectations about social media use.” 

Dr. Romano, also not involved in the study, recommended the website Wait Until 8th to help parents band together to commit to delaying smartphone access until at least eighth grade.

Dr. Gould recommended the Family Media Plan, a tool from the American Academy of Pediatrics that lets users create a customized plan, complete with guidance tailored to each person’s age and the family’s goals. Sample tips: Designate a basket for holding devices during meals, and switch to audiobooks or relaxing music instead of videos to fall asleep at night.
 

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

From movies to billboards to magazine covers – media have been pushing impossible beauty ideals for decades. But the recent rise of social media brings that exposure to new levels, particularly for young people.

“Youth spend, on average, between 6 and 8 hours per day on screens, much of it on social media,” said senior study author Gary S. Goldfield, PhD, senior scientist at Children’s Hospital of Eastern Ontario Research Institute in Ottawa, Canada. “Social media provides exposure to so many photo-edited pictures – including those of models, celebrities, and fitness instructors – that perpetuate an unattainable beauty standard that gets internalized by impressionable youth and young adults, leading to body dissatisfaction.”

Plenty of research has linked frequent social media use with body image issues and even eating disorders. But crucial gaps in our knowledge remain, Dr. Goldfield said.

Much of that research “is correlational,” Dr. Goldfield added. And studies don’t always focus on individuals who may be more vulnerable to social media’s harmful effects, such as those with ruminative or brooding cognitive styles, affecting results.

And none have explored an obvious question: Can cutting down on social media use also diminish its potential harms?

Dr. Goldfield and his colleagues found an answer: Yes, it can.  

Limiting social media use to 1 hour per day helped older teens and young adults feel much better about their weight and appearance after only 3 weeks, according to the study in Psychology of Popular Media, a journal of the American Psychological Association.

“Our randomized controlled design allowed us to show a stronger causal link between social media use and body image in youth, compared to previous research,” Dr. Goldfield said. “To our knowledge, this is the first study to show that social media use reduction leads to enhanced body image.”

Nancy Lee Zucker, PhD, professor of psychology and neuroscience at Duke University, Durham, N.C., and director of the Duke Center for Eating Disorders, said the results provide needed data that could help guide young people and parents on optimal social media use. Dr. Zucker was not involved in the study.
 

What the researchers did

For the study, Dr. Goldfield and colleagues recruited undergraduate psychology students aged 17-25 who averaged at least 2 hours per day of social media use on smartphones, and who had symptoms of depression or anxiety.

Participants were not told the purpose of the study, and their social media use was monitored by a screen time tracking program. At the beginning and end of the study, they answered questions such as “I’m pretty happy about the way I look,” and “I am satisfied with my weight,” on a 1 (never) to 5 (always) Likert scale.

During the first week, all 220 participants (76% female, 23% male, and 1% other) were told to use social media on their smartphones as they usually do. Over the next 3 weeks, 117 students were told to limit their social media use to 1 hour per day, while the rest were instructed to carry on as usual. In both groups, over 70% of participants were between age 17 and 19. 

The first group cut their social media use by about 50%, from a mean of around 168 minutes per day during week 1 to around 78 minutes per day by the end of week 4, while the unrestricted group went from around 181 minutes per day to 189.
 

Cutting use by around half yielded quick, significant improvements

The students who curbed their social media use saw significant improvements in their “appearance esteem” (from 2.95 to 3.15 points; P <.001) and their “weight esteem” (from 3.16 to 3.32 points; P < .001), whereas those who used social media freely saw no such changes (from 2.72 to 2.76; P = .992 and 3.01 to 3.02; P = .654, respectively). No gender differences between the groups were found.

The researchers are now studying possible reasons for these findings.

The changes in appearance scores “represent a small- to medium-effect size,” said child psychologist Sara R. Gould, PhD, director of the Eating Disorders Center at Children’s Mercy Kansas City in Missouri, who was not associated with the research.“ As such, these are clinically meaningful results, particularly since they were achieved in only 3 weeks. Even small impacts can be added to other changes to create larger impacts or have the potential to grow over time.”
 

The push to limit social media

As more and more experts scrutinize the impact of social media on young people’s mental health, social media companies have responded with features designed to limit the time young users spend on their platforms.

Just this year, Instagram rolled out “quiet mode,” which lets users shut down their direct messages (DMs) for a specified amount of time. To turn on quiet mode, users can navigate to their profiles, and select the triple line icon, “settings,” “notifications,” and “quiet mode.” Another option: Tap the triple line icon, “your activity,” and “time spent” to set reminders to take breaks after 10, 20, or 30 minutes of use.  

TikTok users under 18 will soon have their accounts defaulted to a 1-hour daily screen-time limit, TikTok has announced. Unlike other similar features, it will require users to turn it off rather than turn it on.

Leveraging built-in controls is “a good start to being more intentional about your screen time,” suggested lead author Helen Thai, a PhD student in clinical psychology at McGill University in Montreal. “Unfortunately, users can easily bypass these settings.”  

One reason for social’s magnetic pull: “FOMO – fear of missing out – on what friends are doing can make cutting back on social media use difficult,” said Dr. Zucker. To help prevent FOMO, parents may consider talking to parents of their children’s friends about reducing usage for all the children, Dr. Zucker suggested.

Mary E. Romano, MD, MPH, associate professor of pediatrics-adolescent medicine at Vanderbilt University, Nashville, Tenn., urges parents “to have very clear rules and expectations about social media use.” 

Dr. Romano, also not involved in the study, recommended the website Wait Until 8th to help parents band together to commit to delaying smartphone access until at least eighth grade.

Dr. Gould recommended the Family Media Plan, a tool from the American Academy of Pediatrics that lets users create a customized plan, complete with guidance tailored to each person’s age and the family’s goals. Sample tips: Designate a basket for holding devices during meals, and switch to audiobooks or relaxing music instead of videos to fall asleep at night.
 

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

Most medical professionals would agree that people with eating disorders, including anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED), have serious diseases that result in greater morbidity and mortality compared with those in the general population. Although these do not represent the entire spectrum of eating disorders, these are the ones with the most available research data.

There might be some disagreements on who should be screened, how they should be screened and diagnosed, and how to develop a treatment plan. Some of these may be due to recent changes in physicians’ thinking about who can get an eating disorder. Eating disorders were previously thought to be diseases of affluent white females. Over the past few years, however, it has become more widely accepted that eating disorders may be found across people of a variety of identities and socioeconomic statuses. Clinicians have also become concerned that the incidence of eating disorders has increased and that part of this occurred during the COVID pandemic.
 

APA’s guideline

In February 2023, the American Psychiatric Association released its first update to the Guideline of Treatment of Patients with Eating Disorders. This is the first update to the guideline since 2006. The guideline was updated with the additional evidence that is now available as further studies have been published since the last update. The 2023 guideline provides nine recommendations for assessment and determination of a treatment plan. It then provides three recommendations specifically for AN and two recommendations each for BN and BED. The introduction acknowledges an unsuccessful attempt to provide recommendations for avoidant/restrictive food intake disorder due to the paucity of evidence on this disease.

The first recommendation within the guidelines indicates “the clinician should be sure to ask all patients about the presence of eating disorder symptoms as part of their standard psychiatric evaluation.” This recommendation is provided as there are many with normal or elevated BMI who may have eating disorders and the identification could provide the prevention of significant morbidity and mortality. It includes screening questions that can be used and standardized screening questionnaires.

Other recommendations go on to describe further evaluation for diagnosis, aspects of the history that should be obtained, and specific treatment modalities that can be used, including cognitive behavioral therapy and oral medications that have been approved for use in eating disorder treatments.¹
 

AAP’s clinical report

These guidelines add to the recommendations provided by the American Academy of Pediatrics, which published a clinical report on the Identification and Management of Eating Disorders in Children and Adolescents in January 2021. In this guidance document, the AAP recommends screening for eating disorders in any children or adolescents with “reported dieting, body image dissatisfaction, experiences of weight-based stigma, or changes in eating or exercise” and those with weight loss or rapid weight fluctuations.

If there are concerns, then a full assessment is warranted, the recommendations say. When a patient is diagnosed with an eating disorder, this clinical report also provides recommendations on history, exam, and treatment pathways.²

USPSTF’s recommendation

The United States Preventive Services Task Force provides a recommendation that differs from the AAP and APA’s. In March 2022, the USPSTF published a Grade I recommendation. They state: “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for eating disorders in adolescents and adults.”

They provide several reasons as to why this was given a Grade I. One reason is the paucity of data that exists on the incidence and/or benefit of screening for eating disorders amongst those who are asymptomatic. They also discuss the potential harms of false positive results of screening for both the patients and health care system. The questionnaires identified were the same as those discussed in both the APA and AAP recommendations.

The USPSTF full guideline also provides a call for further studies that would help provide guidance for primary care clinicians in the area of eating disorders.³
 

Takeaway message

With all this information, what is the primary care clinician to do? It does not seem to me that the APA guideline provides new information on how to identify patients best served by screening for eating disorders.

I am not sure it is reasonable for the primary care physician (PCP) to add these questions to every well visit when assessing the mental health status of patients.

There are ways in which this new guideline can be useful to the PCP, however. Among these are that it provides good resources for further evaluation for patients for whom the PCP may have concerns about eating disorders. It also includes screening tests that do not take much time to complete and clear aspects of the history, physical exam, and laboratory evaluation that can be used to provide further clarification and possible diagnosis. Additionally, this guideline provides clear advice on treatment recommendations of therapy and medications to start. This is especially important as wait times for psychiatric providers seem to always be increasing.

A trusted PCP can use these guidelines to start providing their patient with the help they need. Overall, these new recommendations will not change my screening practices, but they will provide assistance in diagnosis and management of my patients.
 

References

1. Guideline Writing Group. The American Psychiatric Association Practice Guideline for the Treatment of Patients With Eating Disorders. 2023. doi: 10.1176/appi.books.9780890424865.

2. Hornberger LL et al. Identification and Management of Eating Disorders in Children and Adolescents. Pediatrics. 2021;147 (1): e2020040279. doi: 10.1542/peds.2020-040279.

3. Feltner C et al. Screening for Eating Disorders in Adolescents and Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2022;327(11): 1068-82. doi: 10.1001/jama.2022.1807.

Most medical professionals would agree that people with eating disorders, including anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED), have serious diseases that result in greater morbidity and mortality compared with those in the general population. Although these do not represent the entire spectrum of eating disorders, these are the ones with the most available research data.

There might be some disagreements on who should be screened, how they should be screened and diagnosed, and how to develop a treatment plan. Some of these may be due to recent changes in physicians’ thinking about who can get an eating disorder. Eating disorders were previously thought to be diseases of affluent white females. Over the past few years, however, it has become more widely accepted that eating disorders may be found across people of a variety of identities and socioeconomic statuses. Clinicians have also become concerned that the incidence of eating disorders has increased and that part of this occurred during the COVID pandemic.
 

APA’s guideline

In February 2023, the American Psychiatric Association released its first update to the Guideline of Treatment of Patients with Eating Disorders. This is the first update to the guideline since 2006. The guideline was updated with the additional evidence that is now available as further studies have been published since the last update. The 2023 guideline provides nine recommendations for assessment and determination of a treatment plan. It then provides three recommendations specifically for AN and two recommendations each for BN and BED. The introduction acknowledges an unsuccessful attempt to provide recommendations for avoidant/restrictive food intake disorder due to the paucity of evidence on this disease.

The first recommendation within the guidelines indicates “the clinician should be sure to ask all patients about the presence of eating disorder symptoms as part of their standard psychiatric evaluation.” This recommendation is provided as there are many with normal or elevated BMI who may have eating disorders and the identification could provide the prevention of significant morbidity and mortality. It includes screening questions that can be used and standardized screening questionnaires.

Other recommendations go on to describe further evaluation for diagnosis, aspects of the history that should be obtained, and specific treatment modalities that can be used, including cognitive behavioral therapy and oral medications that have been approved for use in eating disorder treatments.¹
 

AAP’s clinical report

These guidelines add to the recommendations provided by the American Academy of Pediatrics, which published a clinical report on the Identification and Management of Eating Disorders in Children and Adolescents in January 2021. In this guidance document, the AAP recommends screening for eating disorders in any children or adolescents with “reported dieting, body image dissatisfaction, experiences of weight-based stigma, or changes in eating or exercise” and those with weight loss or rapid weight fluctuations.

If there are concerns, then a full assessment is warranted, the recommendations say. When a patient is diagnosed with an eating disorder, this clinical report also provides recommendations on history, exam, and treatment pathways.²

USPSTF’s recommendation

The United States Preventive Services Task Force provides a recommendation that differs from the AAP and APA’s. In March 2022, the USPSTF published a Grade I recommendation. They state: “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for eating disorders in adolescents and adults.”

They provide several reasons as to why this was given a Grade I. One reason is the paucity of data that exists on the incidence and/or benefit of screening for eating disorders amongst those who are asymptomatic. They also discuss the potential harms of false positive results of screening for both the patients and health care system. The questionnaires identified were the same as those discussed in both the APA and AAP recommendations.

The USPSTF full guideline also provides a call for further studies that would help provide guidance for primary care clinicians in the area of eating disorders.³
 

Takeaway message

With all this information, what is the primary care clinician to do? It does not seem to me that the APA guideline provides new information on how to identify patients best served by screening for eating disorders.

I am not sure it is reasonable for the primary care physician (PCP) to add these questions to every well visit when assessing the mental health status of patients.

There are ways in which this new guideline can be useful to the PCP, however. Among these are that it provides good resources for further evaluation for patients for whom the PCP may have concerns about eating disorders. It also includes screening tests that do not take much time to complete and clear aspects of the history, physical exam, and laboratory evaluation that can be used to provide further clarification and possible diagnosis. Additionally, this guideline provides clear advice on treatment recommendations of therapy and medications to start. This is especially important as wait times for psychiatric providers seem to always be increasing.

A trusted PCP can use these guidelines to start providing their patient with the help they need. Overall, these new recommendations will not change my screening practices, but they will provide assistance in diagnosis and management of my patients.
 

References

1. Guideline Writing Group. The American Psychiatric Association Practice Guideline for the Treatment of Patients With Eating Disorders. 2023. doi: 10.1176/appi.books.9780890424865.

2. Hornberger LL et al. Identification and Management of Eating Disorders in Children and Adolescents. Pediatrics. 2021;147 (1): e2020040279. doi: 10.1542/peds.2020-040279.

3. Feltner C et al. Screening for Eating Disorders in Adolescents and Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2022;327(11): 1068-82. doi: 10.1001/jama.2022.1807.

Most medical professionals would agree that people with eating disorders, including anorexia nervosa (AN), bulimia nervosa (BN), and binge-eating disorder (BED), have serious diseases that result in greater morbidity and mortality compared with those in the general population. Although these do not represent the entire spectrum of eating disorders, these are the ones with the most available research data.

There might be some disagreements on who should be screened, how they should be screened and diagnosed, and how to develop a treatment plan. Some of these may be due to recent changes in physicians’ thinking about who can get an eating disorder. Eating disorders were previously thought to be diseases of affluent white females. Over the past few years, however, it has become more widely accepted that eating disorders may be found across people of a variety of identities and socioeconomic statuses. Clinicians have also become concerned that the incidence of eating disorders has increased and that part of this occurred during the COVID pandemic.
 

APA’s guideline

In February 2023, the American Psychiatric Association released its first update to the Guideline of Treatment of Patients with Eating Disorders. This is the first update to the guideline since 2006. The guideline was updated with the additional evidence that is now available as further studies have been published since the last update. The 2023 guideline provides nine recommendations for assessment and determination of a treatment plan. It then provides three recommendations specifically for AN and two recommendations each for BN and BED. The introduction acknowledges an unsuccessful attempt to provide recommendations for avoidant/restrictive food intake disorder due to the paucity of evidence on this disease.

The first recommendation within the guidelines indicates “the clinician should be sure to ask all patients about the presence of eating disorder symptoms as part of their standard psychiatric evaluation.” This recommendation is provided as there are many with normal or elevated BMI who may have eating disorders and the identification could provide the prevention of significant morbidity and mortality. It includes screening questions that can be used and standardized screening questionnaires.

Other recommendations go on to describe further evaluation for diagnosis, aspects of the history that should be obtained, and specific treatment modalities that can be used, including cognitive behavioral therapy and oral medications that have been approved for use in eating disorder treatments.¹
 

AAP’s clinical report

These guidelines add to the recommendations provided by the American Academy of Pediatrics, which published a clinical report on the Identification and Management of Eating Disorders in Children and Adolescents in January 2021. In this guidance document, the AAP recommends screening for eating disorders in any children or adolescents with “reported dieting, body image dissatisfaction, experiences of weight-based stigma, or changes in eating or exercise” and those with weight loss or rapid weight fluctuations.

If there are concerns, then a full assessment is warranted, the recommendations say. When a patient is diagnosed with an eating disorder, this clinical report also provides recommendations on history, exam, and treatment pathways.²

USPSTF’s recommendation

The United States Preventive Services Task Force provides a recommendation that differs from the AAP and APA’s. In March 2022, the USPSTF published a Grade I recommendation. They state: “The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for eating disorders in adolescents and adults.”

They provide several reasons as to why this was given a Grade I. One reason is the paucity of data that exists on the incidence and/or benefit of screening for eating disorders amongst those who are asymptomatic. They also discuss the potential harms of false positive results of screening for both the patients and health care system. The questionnaires identified were the same as those discussed in both the APA and AAP recommendations.

The USPSTF full guideline also provides a call for further studies that would help provide guidance for primary care clinicians in the area of eating disorders.³
 

Takeaway message

With all this information, what is the primary care clinician to do? It does not seem to me that the APA guideline provides new information on how to identify patients best served by screening for eating disorders.

I am not sure it is reasonable for the primary care physician (PCP) to add these questions to every well visit when assessing the mental health status of patients.

There are ways in which this new guideline can be useful to the PCP, however. Among these are that it provides good resources for further evaluation for patients for whom the PCP may have concerns about eating disorders. It also includes screening tests that do not take much time to complete and clear aspects of the history, physical exam, and laboratory evaluation that can be used to provide further clarification and possible diagnosis. Additionally, this guideline provides clear advice on treatment recommendations of therapy and medications to start. This is especially important as wait times for psychiatric providers seem to always be increasing.

A trusted PCP can use these guidelines to start providing their patient with the help they need. Overall, these new recommendations will not change my screening practices, but they will provide assistance in diagnosis and management of my patients.
 

References

1. Guideline Writing Group. The American Psychiatric Association Practice Guideline for the Treatment of Patients With Eating Disorders. 2023. doi: 10.1176/appi.books.9780890424865.

2. Hornberger LL et al. Identification and Management of Eating Disorders in Children and Adolescents. Pediatrics. 2021;147 (1): e2020040279. doi: 10.1542/peds.2020-040279.

3. Feltner C et al. Screening for Eating Disorders in Adolescents and Adults: Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2022;327(11): 1068-82. doi: 10.1001/jama.2022.1807.

A hybrid closed-loop automated insulin delivery system improved time-in-range for blood glucose, compared with standard care, for children with type 1 diabetes in a 13-week trial.

The hybrid closed-loop system, also called automated insulin delivery or artificial pancreas, was composed of a t:slim X2 insulin pump, a Dexcom G6 continuous glucose monitor (CGM), and Control-IQ technology system algorithm software (Tandem Diabetes Care). The system was approved in the United States in 2018 for adults and children as young as 6 years.

Type 1 diabetes treatment is particularly challenging in children younger than 6 because of their small insulin dosing requirements and unpredictable eating and activity habits, lead author R. Paul Wadwa, MD, of the Barbara Davis Center for Diabetes, University of Colorado at Denver, Aurora, and colleagues wrote.

Thus far in the United States, only the Medtronic MiniMed 770G and the Omnipod 5 automated insulin delivery systems are approved for children as young as 2 years, they noted.

In the current study of 102 children with type 1 diabetes aged at least 2 years but younger than 6 years, time-in-range over 13 weeks was higher for those randomized to the hybrid closed-loop system, compared with standard of care; the latter included either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.

The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared with no change with standard care.

Moreover, the trial was conducted during the COVID-19 pandemic, necessitating virtual care for most of the study participants. As a result, more than 80% of the training on use of the system and over 90% of all the visits were conducted virtually.

“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” the investigators wrote.

Their findings were published online in the New England Journal of Medicine.

“These results suggest that, in very young children, closed-loop systems are superior to standard care with respect to glucose control,” Daniela Bruttomesso, MD, PhD, of the University of Padua (Italy) wrote in an accompanying editorial.

“Moreover, they show that the closed-loop system can be started remotely in children in this age range, with results that are similar to those obtained when parents or guardians receive face-to-face education about the use of these systems. The closed-loop system used in this trial appeared to be safe and effective.”

Dr. Bruttomesso added: “Although the results were solid, the trial period was only 13 weeks, and there were more unscheduled contacts in the closed-loop group than in the standard care group. In addition, the authors compared a closed-loop system with standard care, rather than in-person initiation of a closed-loop system with remote initiation.”
 

More time-in-range, no hypoglycemia with automated system

The 102 children were enrolled in the trial between April 28, 2021, and Jan. 13, 2022, at three different U.S. study sites; 68 children were randomized to the closed-loop system and 34 children to standard care. All but one participant completed the 13-week study.

Both groups had virtual or in-person trial visits at 2, 6, and 13 weeks after randomization, and telephone contact at 1 and 10 weeks. Training was virtual for 55 of the 68 children in the closed-loop group (81%). A total of 91% of 407 study visits in the closed-loop and 96% of 204 study visits in the standard-care group were also virtual.

The mean percentage of time spent in target glucose range (70-180 mg/dL) increased from 56.9% at baseline to 69.3% at 13 weeks for the closed-loop group, compared with virtually no change, from 54.9% to 55.9%, in the standard-care group. The mean adjusted difference between the two groups was significant (P < .001).

The closed-loop group also spent significantly less time than the standard-care group with glucose levels above 250 mg/dL during the study period (8.4% vs. 15.0%; P < .001), had lower mean glucose levels (155 vs. 174 mg/dL; P < .001), and lower hemoglobin A1c (7.0% vs. 7.5%; P < .001).

However, time spent with glucose levels below 70 mg/dL (3.0% vs. 3.0%; P = .57) and below 54 mg/dL (0.6% vs. 0.5%) didn’t differ between the groups. 

There were two cases of severe hypoglycemia in the closed-loop group and one in the standard-care group. One case of diabetic ketoacidosis related to infusion set failure occurred in the closed-loop group versus none in the standard-care group.

Dr. Bruttomesso commented that a virtual approach has several advantages over in-person visits, including “a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”

At the same time, though, “patient preferences, possible legal issues, and accessibility to technology ... are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.” The families of the patients in this trial had above-average incomes, she pointed out.

Ultimately, she said, “A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Wadwa reported receiving grants/contracts from Beta Bionics, Dexcom, Eli Lilly, and MannKind, travel fees from Eli Lilly, and lecture fees from Tandem Diabetes Care, and serves as a consultant for Dexcom. Dr. Bruttomesso reported no relevant financial relationships.

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

A hybrid closed-loop automated insulin delivery system improved time-in-range for blood glucose, compared with standard care, for children with type 1 diabetes in a 13-week trial.

The hybrid closed-loop system, also called automated insulin delivery or artificial pancreas, was composed of a t:slim X2 insulin pump, a Dexcom G6 continuous glucose monitor (CGM), and Control-IQ technology system algorithm software (Tandem Diabetes Care). The system was approved in the United States in 2018 for adults and children as young as 6 years.

Type 1 diabetes treatment is particularly challenging in children younger than 6 because of their small insulin dosing requirements and unpredictable eating and activity habits, lead author R. Paul Wadwa, MD, of the Barbara Davis Center for Diabetes, University of Colorado at Denver, Aurora, and colleagues wrote.

Thus far in the United States, only the Medtronic MiniMed 770G and the Omnipod 5 automated insulin delivery systems are approved for children as young as 2 years, they noted.

In the current study of 102 children with type 1 diabetes aged at least 2 years but younger than 6 years, time-in-range over 13 weeks was higher for those randomized to the hybrid closed-loop system, compared with standard of care; the latter included either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.

The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared with no change with standard care.

Moreover, the trial was conducted during the COVID-19 pandemic, necessitating virtual care for most of the study participants. As a result, more than 80% of the training on use of the system and over 90% of all the visits were conducted virtually.

“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” the investigators wrote.

Their findings were published online in the New England Journal of Medicine.

“These results suggest that, in very young children, closed-loop systems are superior to standard care with respect to glucose control,” Daniela Bruttomesso, MD, PhD, of the University of Padua (Italy) wrote in an accompanying editorial.

“Moreover, they show that the closed-loop system can be started remotely in children in this age range, with results that are similar to those obtained when parents or guardians receive face-to-face education about the use of these systems. The closed-loop system used in this trial appeared to be safe and effective.”

Dr. Bruttomesso added: “Although the results were solid, the trial period was only 13 weeks, and there were more unscheduled contacts in the closed-loop group than in the standard care group. In addition, the authors compared a closed-loop system with standard care, rather than in-person initiation of a closed-loop system with remote initiation.”
 

More time-in-range, no hypoglycemia with automated system

The 102 children were enrolled in the trial between April 28, 2021, and Jan. 13, 2022, at three different U.S. study sites; 68 children were randomized to the closed-loop system and 34 children to standard care. All but one participant completed the 13-week study.

Both groups had virtual or in-person trial visits at 2, 6, and 13 weeks after randomization, and telephone contact at 1 and 10 weeks. Training was virtual for 55 of the 68 children in the closed-loop group (81%). A total of 91% of 407 study visits in the closed-loop and 96% of 204 study visits in the standard-care group were also virtual.

The mean percentage of time spent in target glucose range (70-180 mg/dL) increased from 56.9% at baseline to 69.3% at 13 weeks for the closed-loop group, compared with virtually no change, from 54.9% to 55.9%, in the standard-care group. The mean adjusted difference between the two groups was significant (P < .001).

The closed-loop group also spent significantly less time than the standard-care group with glucose levels above 250 mg/dL during the study period (8.4% vs. 15.0%; P < .001), had lower mean glucose levels (155 vs. 174 mg/dL; P < .001), and lower hemoglobin A1c (7.0% vs. 7.5%; P < .001).

However, time spent with glucose levels below 70 mg/dL (3.0% vs. 3.0%; P = .57) and below 54 mg/dL (0.6% vs. 0.5%) didn’t differ between the groups. 

There were two cases of severe hypoglycemia in the closed-loop group and one in the standard-care group. One case of diabetic ketoacidosis related to infusion set failure occurred in the closed-loop group versus none in the standard-care group.

Dr. Bruttomesso commented that a virtual approach has several advantages over in-person visits, including “a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”

At the same time, though, “patient preferences, possible legal issues, and accessibility to technology ... are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.” The families of the patients in this trial had above-average incomes, she pointed out.

Ultimately, she said, “A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Wadwa reported receiving grants/contracts from Beta Bionics, Dexcom, Eli Lilly, and MannKind, travel fees from Eli Lilly, and lecture fees from Tandem Diabetes Care, and serves as a consultant for Dexcom. Dr. Bruttomesso reported no relevant financial relationships.

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

A hybrid closed-loop automated insulin delivery system improved time-in-range for blood glucose, compared with standard care, for children with type 1 diabetes in a 13-week trial.

The hybrid closed-loop system, also called automated insulin delivery or artificial pancreas, was composed of a t:slim X2 insulin pump, a Dexcom G6 continuous glucose monitor (CGM), and Control-IQ technology system algorithm software (Tandem Diabetes Care). The system was approved in the United States in 2018 for adults and children as young as 6 years.

Type 1 diabetes treatment is particularly challenging in children younger than 6 because of their small insulin dosing requirements and unpredictable eating and activity habits, lead author R. Paul Wadwa, MD, of the Barbara Davis Center for Diabetes, University of Colorado at Denver, Aurora, and colleagues wrote.

Thus far in the United States, only the Medtronic MiniMed 770G and the Omnipod 5 automated insulin delivery systems are approved for children as young as 2 years, they noted.

In the current study of 102 children with type 1 diabetes aged at least 2 years but younger than 6 years, time-in-range over 13 weeks was higher for those randomized to the hybrid closed-loop system, compared with standard of care; the latter included either an insulin pump or multiple daily injections plus a separate Dexcom G6 CGM.

The hybrid closed-loop system added an average of about 3 hours in ideal blood glucose range over the 13 weeks, compared with no change with standard care.

Moreover, the trial was conducted during the COVID-19 pandemic, necessitating virtual care for most of the study participants. As a result, more than 80% of the training on use of the system and over 90% of all the visits were conducted virtually.

“Successful use of the closed-loop system under these conditions is an important finding that could affect the approach to initiating and monitoring the use of the closed-loop system and expand the use of such systems, particularly in patients living in areas without an endocrinologist but with reliable internet access,” the investigators wrote.

Their findings were published online in the New England Journal of Medicine.

“These results suggest that, in very young children, closed-loop systems are superior to standard care with respect to glucose control,” Daniela Bruttomesso, MD, PhD, of the University of Padua (Italy) wrote in an accompanying editorial.

“Moreover, they show that the closed-loop system can be started remotely in children in this age range, with results that are similar to those obtained when parents or guardians receive face-to-face education about the use of these systems. The closed-loop system used in this trial appeared to be safe and effective.”

Dr. Bruttomesso added: “Although the results were solid, the trial period was only 13 weeks, and there were more unscheduled contacts in the closed-loop group than in the standard care group. In addition, the authors compared a closed-loop system with standard care, rather than in-person initiation of a closed-loop system with remote initiation.”
 

More time-in-range, no hypoglycemia with automated system

The 102 children were enrolled in the trial between April 28, 2021, and Jan. 13, 2022, at three different U.S. study sites; 68 children were randomized to the closed-loop system and 34 children to standard care. All but one participant completed the 13-week study.

Both groups had virtual or in-person trial visits at 2, 6, and 13 weeks after randomization, and telephone contact at 1 and 10 weeks. Training was virtual for 55 of the 68 children in the closed-loop group (81%). A total of 91% of 407 study visits in the closed-loop and 96% of 204 study visits in the standard-care group were also virtual.

The mean percentage of time spent in target glucose range (70-180 mg/dL) increased from 56.9% at baseline to 69.3% at 13 weeks for the closed-loop group, compared with virtually no change, from 54.9% to 55.9%, in the standard-care group. The mean adjusted difference between the two groups was significant (P < .001).

The closed-loop group also spent significantly less time than the standard-care group with glucose levels above 250 mg/dL during the study period (8.4% vs. 15.0%; P < .001), had lower mean glucose levels (155 vs. 174 mg/dL; P < .001), and lower hemoglobin A1c (7.0% vs. 7.5%; P < .001).

However, time spent with glucose levels below 70 mg/dL (3.0% vs. 3.0%; P = .57) and below 54 mg/dL (0.6% vs. 0.5%) didn’t differ between the groups. 

There were two cases of severe hypoglycemia in the closed-loop group and one in the standard-care group. One case of diabetic ketoacidosis related to infusion set failure occurred in the closed-loop group versus none in the standard-care group.

Dr. Bruttomesso commented that a virtual approach has several advantages over in-person visits, including “a more relaxed environment, lower travel costs, and greater ease of contact with clinicians.”

At the same time, though, “patient preferences, possible legal issues, and accessibility to technology ... are all important considerations in choosing the most appropriate way to communicate with patients at the initiation of a closed-loop system or during routine follow-up.” The families of the patients in this trial had above-average incomes, she pointed out.

Ultimately, she said, “A mix of face-to-face visits and virtual clinic meetings may become routine in the management of diabetes in young children.”

The study was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Wadwa reported receiving grants/contracts from Beta Bionics, Dexcom, Eli Lilly, and MannKind, travel fees from Eli Lilly, and lecture fees from Tandem Diabetes Care, and serves as a consultant for Dexcom. Dr. Bruttomesso reported no relevant financial relationships.

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

Atopic dermatitis (AD) monotherapy with the lebrikizumab, an interleukin-13 inhibitor, was shown to be both effective and safe in the induction periods of the phase 3 ADvocate1 and ADvocate2 trials, researchers reported in the New England Journal of Medicine.

The identically designed, 52-week, randomized, double-blind, placebo-controlled trials enrolled 851 adolescents and adults with moderate to severe AD and included a 16-week induction period followed by a 36-week maintenance period. At week 16, the results “show a rapid onset of action in multiple domains of the disease, such as skin clearance and itch,” wrote lead author Jonathan Silverberg, MD, PhD, director of clinical research and contact dermatitis, at George Washington University, Washington, and colleagues. “Although 16 weeks of treatment with lebrikizumab is not sufficient to assess its long-term safety, the results from the induction period of these two trials suggest a safety profile that is consistent with findings in previous trials,” they added.

Results presented at the European Academy of Dermatology and Venereology 2022 annual meeting, but not yet published, showed similar efficacy maintained through the end of the trial.

Eligible patients were randomly assigned to receive either lebrikizumab 250 mg (with a 500-mg loading dose given at baseline and at week 2) or placebo, administered subcutaneously every 2 weeks, with concomitant topical or systemic treatments prohibited through week 16 except when deemed appropriate as rescue therapy. In such cases, moderate-potency topical glucocorticoids were preferred as first-line rescue therapy, while the study drug was discontinued if systemic therapy was needed.

In both trials, the primary efficacy outcome – a score of 0 or 1 on the Investigator’s Global Assessment (IGA) – and a reduction of at least 2 points from baseline at week 16, was met by more patients treated with lebrikizumab than with placebo: 43.1% vs. 12.7% respectively in trial 1 (P < .001); and 33.2% vs. 10.8% in trial 2 (P < .001).

Similarly, in both trials, a higher percentage of the lebrikizumab than placebo patients had an EASI-75 response (75% improvement in the Eczema Area and Severity Index score): 58.8% vs. 16.2% (P < .001) in trial 1 and 52.1% vs. 18.1% (P < .001) in trial 2.

Improvement in itch was also significantly better in patients treated with lebrikizumab, compared with placebo. This was measured by a reduction of at least 4 points in the Pruritus NRS from baseline to week 16 and a reduction in the Sleep-Loss Scale score of at least 2 points from baseline to week 16 (P < .001 for both measures in both trials).

A higher percentage of placebo vs. lebrikizumab patients discontinued the trials during the induction phases (14.9% vs. 7.1% in trial 1 and 11.0% vs. 7.8% in trial 2), and the use of rescue medication was approximately three times and two times higher in both placebo groups respectively.

Conjunctivitis was the most common adverse event, occurring consistently more frequently in patients treated with lebrikizumab, compared with placebo (7.4% vs. 2.8% in trial 1 and 7.5% vs. 2.1% in trial 2).

“Although several theories have been proposed for the pathogenesis of conjunctivitis in patients with atopic dermatitis treated with this class of biologic agents, the mechanism remains unclear and warrants further study,” the investigators wrote.

Asked to comment on the new results, Zelma Chiesa Fuxench, MD, who was not involved in the research, said they “continue to demonstrate the superior efficacy and favorable safety profile” of lebrikizumab in adolescents and adults and support the results of earlier phase 2 studies. “The results of these studies thus far continue to offer more hope and the possibility of a better future for our patients with atopic dermatitis who are still struggling to achieve control of their disease.”

Dr. Chiesa Fuxench from the department of dermatology at the University of Pennsylvania, Philadelphia, said she looks forward to reviewing the full study results in which patients who achieved the primary outcomes of interest were then rerandomized to either placebo, or lebrikizumab every 2 weeks or every 4 weeks for the 36-week maintenance period “because we know that there is data for other biologics in atopic dermatitis (such as tralokinumab) that demonstrate that a decrease in the frequency of injections may be possible for patients who achieve disease control after an initial 16 weeks of therapy every 2 weeks.”

The research was supported by Dermira, a wholly owned subsidiary of Eli Lilly. Dr. Silverberg disclosed he is a consultant for Dermira and Eli Lilly, as are other coauthors on the paper who additionally disclosed grants from Dermira and other relationships with Eli Lilly such as advisory board membership and having received lecture fees. Three authors are Eli Lilly employees. Dr. Chiesa Fuxench disclosed that she is a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, Pfizer, Abbvie, and Incyte for which she has received honoraria for work related to AD. Dr. Chiesa Fuxench has also been a recipient of research grants from Regeneron, Sanofi, Tioga, Vanda, Menlo Therapeutics, Leo Pharma, and Eli Lilly for work related to AD as well as honoraria for continuing medical education work related to AD sponsored through educational grants from Regeneron/Sanofi and Pfizer.

Atopic dermatitis (AD) monotherapy with the lebrikizumab, an interleukin-13 inhibitor, was shown to be both effective and safe in the induction periods of the phase 3 ADvocate1 and ADvocate2 trials, researchers reported in the New England Journal of Medicine.

The identically designed, 52-week, randomized, double-blind, placebo-controlled trials enrolled 851 adolescents and adults with moderate to severe AD and included a 16-week induction period followed by a 36-week maintenance period. At week 16, the results “show a rapid onset of action in multiple domains of the disease, such as skin clearance and itch,” wrote lead author Jonathan Silverberg, MD, PhD, director of clinical research and contact dermatitis, at George Washington University, Washington, and colleagues. “Although 16 weeks of treatment with lebrikizumab is not sufficient to assess its long-term safety, the results from the induction period of these two trials suggest a safety profile that is consistent with findings in previous trials,” they added.

Results presented at the European Academy of Dermatology and Venereology 2022 annual meeting, but not yet published, showed similar efficacy maintained through the end of the trial.

Eligible patients were randomly assigned to receive either lebrikizumab 250 mg (with a 500-mg loading dose given at baseline and at week 2) or placebo, administered subcutaneously every 2 weeks, with concomitant topical or systemic treatments prohibited through week 16 except when deemed appropriate as rescue therapy. In such cases, moderate-potency topical glucocorticoids were preferred as first-line rescue therapy, while the study drug was discontinued if systemic therapy was needed.

In both trials, the primary efficacy outcome – a score of 0 or 1 on the Investigator’s Global Assessment (IGA) – and a reduction of at least 2 points from baseline at week 16, was met by more patients treated with lebrikizumab than with placebo: 43.1% vs. 12.7% respectively in trial 1 (P < .001); and 33.2% vs. 10.8% in trial 2 (P < .001).

Similarly, in both trials, a higher percentage of the lebrikizumab than placebo patients had an EASI-75 response (75% improvement in the Eczema Area and Severity Index score): 58.8% vs. 16.2% (P < .001) in trial 1 and 52.1% vs. 18.1% (P < .001) in trial 2.

Improvement in itch was also significantly better in patients treated with lebrikizumab, compared with placebo. This was measured by a reduction of at least 4 points in the Pruritus NRS from baseline to week 16 and a reduction in the Sleep-Loss Scale score of at least 2 points from baseline to week 16 (P < .001 for both measures in both trials).

A higher percentage of placebo vs. lebrikizumab patients discontinued the trials during the induction phases (14.9% vs. 7.1% in trial 1 and 11.0% vs. 7.8% in trial 2), and the use of rescue medication was approximately three times and two times higher in both placebo groups respectively.

Conjunctivitis was the most common adverse event, occurring consistently more frequently in patients treated with lebrikizumab, compared with placebo (7.4% vs. 2.8% in trial 1 and 7.5% vs. 2.1% in trial 2).

“Although several theories have been proposed for the pathogenesis of conjunctivitis in patients with atopic dermatitis treated with this class of biologic agents, the mechanism remains unclear and warrants further study,” the investigators wrote.

Asked to comment on the new results, Zelma Chiesa Fuxench, MD, who was not involved in the research, said they “continue to demonstrate the superior efficacy and favorable safety profile” of lebrikizumab in adolescents and adults and support the results of earlier phase 2 studies. “The results of these studies thus far continue to offer more hope and the possibility of a better future for our patients with atopic dermatitis who are still struggling to achieve control of their disease.”

Dr. Chiesa Fuxench from the department of dermatology at the University of Pennsylvania, Philadelphia, said she looks forward to reviewing the full study results in which patients who achieved the primary outcomes of interest were then rerandomized to either placebo, or lebrikizumab every 2 weeks or every 4 weeks for the 36-week maintenance period “because we know that there is data for other biologics in atopic dermatitis (such as tralokinumab) that demonstrate that a decrease in the frequency of injections may be possible for patients who achieve disease control after an initial 16 weeks of therapy every 2 weeks.”

The research was supported by Dermira, a wholly owned subsidiary of Eli Lilly. Dr. Silverberg disclosed he is a consultant for Dermira and Eli Lilly, as are other coauthors on the paper who additionally disclosed grants from Dermira and other relationships with Eli Lilly such as advisory board membership and having received lecture fees. Three authors are Eli Lilly employees. Dr. Chiesa Fuxench disclosed that she is a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, Pfizer, Abbvie, and Incyte for which she has received honoraria for work related to AD. Dr. Chiesa Fuxench has also been a recipient of research grants from Regeneron, Sanofi, Tioga, Vanda, Menlo Therapeutics, Leo Pharma, and Eli Lilly for work related to AD as well as honoraria for continuing medical education work related to AD sponsored through educational grants from Regeneron/Sanofi and Pfizer.

Atopic dermatitis (AD) monotherapy with the lebrikizumab, an interleukin-13 inhibitor, was shown to be both effective and safe in the induction periods of the phase 3 ADvocate1 and ADvocate2 trials, researchers reported in the New England Journal of Medicine.

The identically designed, 52-week, randomized, double-blind, placebo-controlled trials enrolled 851 adolescents and adults with moderate to severe AD and included a 16-week induction period followed by a 36-week maintenance period. At week 16, the results “show a rapid onset of action in multiple domains of the disease, such as skin clearance and itch,” wrote lead author Jonathan Silverberg, MD, PhD, director of clinical research and contact dermatitis, at George Washington University, Washington, and colleagues. “Although 16 weeks of treatment with lebrikizumab is not sufficient to assess its long-term safety, the results from the induction period of these two trials suggest a safety profile that is consistent with findings in previous trials,” they added.

Results presented at the European Academy of Dermatology and Venereology 2022 annual meeting, but not yet published, showed similar efficacy maintained through the end of the trial.

Eligible patients were randomly assigned to receive either lebrikizumab 250 mg (with a 500-mg loading dose given at baseline and at week 2) or placebo, administered subcutaneously every 2 weeks, with concomitant topical or systemic treatments prohibited through week 16 except when deemed appropriate as rescue therapy. In such cases, moderate-potency topical glucocorticoids were preferred as first-line rescue therapy, while the study drug was discontinued if systemic therapy was needed.

In both trials, the primary efficacy outcome – a score of 0 or 1 on the Investigator’s Global Assessment (IGA) – and a reduction of at least 2 points from baseline at week 16, was met by more patients treated with lebrikizumab than with placebo: 43.1% vs. 12.7% respectively in trial 1 (P < .001); and 33.2% vs. 10.8% in trial 2 (P < .001).

Similarly, in both trials, a higher percentage of the lebrikizumab than placebo patients had an EASI-75 response (75% improvement in the Eczema Area and Severity Index score): 58.8% vs. 16.2% (P < .001) in trial 1 and 52.1% vs. 18.1% (P < .001) in trial 2.

Improvement in itch was also significantly better in patients treated with lebrikizumab, compared with placebo. This was measured by a reduction of at least 4 points in the Pruritus NRS from baseline to week 16 and a reduction in the Sleep-Loss Scale score of at least 2 points from baseline to week 16 (P < .001 for both measures in both trials).

A higher percentage of placebo vs. lebrikizumab patients discontinued the trials during the induction phases (14.9% vs. 7.1% in trial 1 and 11.0% vs. 7.8% in trial 2), and the use of rescue medication was approximately three times and two times higher in both placebo groups respectively.

Conjunctivitis was the most common adverse event, occurring consistently more frequently in patients treated with lebrikizumab, compared with placebo (7.4% vs. 2.8% in trial 1 and 7.5% vs. 2.1% in trial 2).

“Although several theories have been proposed for the pathogenesis of conjunctivitis in patients with atopic dermatitis treated with this class of biologic agents, the mechanism remains unclear and warrants further study,” the investigators wrote.

Asked to comment on the new results, Zelma Chiesa Fuxench, MD, who was not involved in the research, said they “continue to demonstrate the superior efficacy and favorable safety profile” of lebrikizumab in adolescents and adults and support the results of earlier phase 2 studies. “The results of these studies thus far continue to offer more hope and the possibility of a better future for our patients with atopic dermatitis who are still struggling to achieve control of their disease.”

Dr. Chiesa Fuxench from the department of dermatology at the University of Pennsylvania, Philadelphia, said she looks forward to reviewing the full study results in which patients who achieved the primary outcomes of interest were then rerandomized to either placebo, or lebrikizumab every 2 weeks or every 4 weeks for the 36-week maintenance period “because we know that there is data for other biologics in atopic dermatitis (such as tralokinumab) that demonstrate that a decrease in the frequency of injections may be possible for patients who achieve disease control after an initial 16 weeks of therapy every 2 weeks.”

The research was supported by Dermira, a wholly owned subsidiary of Eli Lilly. Dr. Silverberg disclosed he is a consultant for Dermira and Eli Lilly, as are other coauthors on the paper who additionally disclosed grants from Dermira and other relationships with Eli Lilly such as advisory board membership and having received lecture fees. Three authors are Eli Lilly employees. Dr. Chiesa Fuxench disclosed that she is a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, Pfizer, Abbvie, and Incyte for which she has received honoraria for work related to AD. Dr. Chiesa Fuxench has also been a recipient of research grants from Regeneron, Sanofi, Tioga, Vanda, Menlo Therapeutics, Leo Pharma, and Eli Lilly for work related to AD as well as honoraria for continuing medical education work related to AD sponsored through educational grants from Regeneron/Sanofi and Pfizer.

High school students are injuring themselves more severely even as overall injury rates have declined, according to a new study presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

The study compared injuries from a 4-year period ending in 2019 to data from 2005 and 2006. The overall rate of injuries dropped 9%, from 2.51 injuries per 1,000 athletic games or practices to 2.29 per 1,000; injuries requiring less than 1 week of recovery time fell by 13%. But, the number of head and neck injuries increased by 10%, injuries requiring surgery increased by 1%, and injuries leading to medical disqualification jumped by 11%. 

“It’s wonderful that the injury rate is declining,” said Jordan Neoma Pizzarro, a medical student at George Washington University, Washington, who led the study. “But the data does suggest that the injuries that are happening are worse.”

The increases may also reflect increased education and awareness of how to detect concussions and other injuries that need medical attention, said Micah Lissy, MD, MS, an orthopedic surgeon specializing in sports medicine at Michigan State University, East Lansing. Dr. Lissy cautioned against physicians and others taking the data at face value. 

“We need to be implementing preventive measures wherever possible, but I think we can also consider that there may be some confounding factors in the data,” Dr. Lissy told this news organization. 

Ms. Pizzarro and her team analyzed data collected from athletic trainers at 100 high schools across the country for the ongoing National Health School Sports-Related Injury Surveillance Study.

Athletes participating in sports such as football, soccer, basketball, volleyball, and softball were included in the analysis. Trainers report the number of injuries for every competition and practice, also known as “athletic exposures.”

Boys’ football carried the highest injury rate, with 3.96 injuries per 1,000 AEs, amounting to 44% of all injuries reported. Girls’ soccer and boys’ wrestling followed, with injury rates of 2.65 and 1.56, respectively. 

Sprains and strains accounted for 37% of injuries, followed by concussions (21.6%). The head and/or face was the most injured body site, followed by the ankles and/or knees. Most injuries took place during competitions rather than in practices (relative risk, 3.39; 95% confidence interval, 3.28-3.49; P < .05).

Ms. Pizzarro said that an overall increase in intensity, physical contact, and collisions may account for the spike in more severe injuries.

“Kids are encouraged to specialize in one sport early on and stick with it year-round,” she said. “They’re probably becoming more agile and better athletes, but they’re probably also getting more competitive.” 

Dr. Lissy, who has worked with high school athletes as a surgeon, physical therapist, athletic trainer, and coach, said that some of the increases in severity of injuries may reflect trends in sports over the past two decades: Student athletes have become stronger and faster and have put on more muscle mass. 

“When you have something that’s much larger, moving much faster and with more force, you’re going to have more force when you bump into things,” he said. “This can lead to more significant injuries.”

The study was independently supported. Study authors report no relevant financial relationships. 

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

High school students are injuring themselves more severely even as overall injury rates have declined, according to a new study presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

The study compared injuries from a 4-year period ending in 2019 to data from 2005 and 2006. The overall rate of injuries dropped 9%, from 2.51 injuries per 1,000 athletic games or practices to 2.29 per 1,000; injuries requiring less than 1 week of recovery time fell by 13%. But, the number of head and neck injuries increased by 10%, injuries requiring surgery increased by 1%, and injuries leading to medical disqualification jumped by 11%. 

“It’s wonderful that the injury rate is declining,” said Jordan Neoma Pizzarro, a medical student at George Washington University, Washington, who led the study. “But the data does suggest that the injuries that are happening are worse.”

The increases may also reflect increased education and awareness of how to detect concussions and other injuries that need medical attention, said Micah Lissy, MD, MS, an orthopedic surgeon specializing in sports medicine at Michigan State University, East Lansing. Dr. Lissy cautioned against physicians and others taking the data at face value. 

“We need to be implementing preventive measures wherever possible, but I think we can also consider that there may be some confounding factors in the data,” Dr. Lissy told this news organization. 

Ms. Pizzarro and her team analyzed data collected from athletic trainers at 100 high schools across the country for the ongoing National Health School Sports-Related Injury Surveillance Study.

Athletes participating in sports such as football, soccer, basketball, volleyball, and softball were included in the analysis. Trainers report the number of injuries for every competition and practice, also known as “athletic exposures.”

Boys’ football carried the highest injury rate, with 3.96 injuries per 1,000 AEs, amounting to 44% of all injuries reported. Girls’ soccer and boys’ wrestling followed, with injury rates of 2.65 and 1.56, respectively. 

Sprains and strains accounted for 37% of injuries, followed by concussions (21.6%). The head and/or face was the most injured body site, followed by the ankles and/or knees. Most injuries took place during competitions rather than in practices (relative risk, 3.39; 95% confidence interval, 3.28-3.49; P < .05).

Ms. Pizzarro said that an overall increase in intensity, physical contact, and collisions may account for the spike in more severe injuries.

“Kids are encouraged to specialize in one sport early on and stick with it year-round,” she said. “They’re probably becoming more agile and better athletes, but they’re probably also getting more competitive.” 

Dr. Lissy, who has worked with high school athletes as a surgeon, physical therapist, athletic trainer, and coach, said that some of the increases in severity of injuries may reflect trends in sports over the past two decades: Student athletes have become stronger and faster and have put on more muscle mass. 

“When you have something that’s much larger, moving much faster and with more force, you’re going to have more force when you bump into things,” he said. “This can lead to more significant injuries.”

The study was independently supported. Study authors report no relevant financial relationships. 

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

High school students are injuring themselves more severely even as overall injury rates have declined, according to a new study presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

The study compared injuries from a 4-year period ending in 2019 to data from 2005 and 2006. The overall rate of injuries dropped 9%, from 2.51 injuries per 1,000 athletic games or practices to 2.29 per 1,000; injuries requiring less than 1 week of recovery time fell by 13%. But, the number of head and neck injuries increased by 10%, injuries requiring surgery increased by 1%, and injuries leading to medical disqualification jumped by 11%. 

“It’s wonderful that the injury rate is declining,” said Jordan Neoma Pizzarro, a medical student at George Washington University, Washington, who led the study. “But the data does suggest that the injuries that are happening are worse.”

The increases may also reflect increased education and awareness of how to detect concussions and other injuries that need medical attention, said Micah Lissy, MD, MS, an orthopedic surgeon specializing in sports medicine at Michigan State University, East Lansing. Dr. Lissy cautioned against physicians and others taking the data at face value. 

“We need to be implementing preventive measures wherever possible, but I think we can also consider that there may be some confounding factors in the data,” Dr. Lissy told this news organization. 

Ms. Pizzarro and her team analyzed data collected from athletic trainers at 100 high schools across the country for the ongoing National Health School Sports-Related Injury Surveillance Study.

Athletes participating in sports such as football, soccer, basketball, volleyball, and softball were included in the analysis. Trainers report the number of injuries for every competition and practice, also known as “athletic exposures.”

Boys’ football carried the highest injury rate, with 3.96 injuries per 1,000 AEs, amounting to 44% of all injuries reported. Girls’ soccer and boys’ wrestling followed, with injury rates of 2.65 and 1.56, respectively. 

Sprains and strains accounted for 37% of injuries, followed by concussions (21.6%). The head and/or face was the most injured body site, followed by the ankles and/or knees. Most injuries took place during competitions rather than in practices (relative risk, 3.39; 95% confidence interval, 3.28-3.49; P < .05).

Ms. Pizzarro said that an overall increase in intensity, physical contact, and collisions may account for the spike in more severe injuries.

“Kids are encouraged to specialize in one sport early on and stick with it year-round,” she said. “They’re probably becoming more agile and better athletes, but they’re probably also getting more competitive.” 

Dr. Lissy, who has worked with high school athletes as a surgeon, physical therapist, athletic trainer, and coach, said that some of the increases in severity of injuries may reflect trends in sports over the past two decades: Student athletes have become stronger and faster and have put on more muscle mass. 

“When you have something that’s much larger, moving much faster and with more force, you’re going to have more force when you bump into things,” he said. “This can lead to more significant injuries.”

The study was independently supported. Study authors report no relevant financial relationships. 

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

I am a psychiatrist now but had another life teaching English in public high school for 17 years. My teaching life, in which I was an openly gay teacher, spanned 2001-2018 and was divided between two urban California schools – in Berkeley and San Leandro. I came out by responding honestly to student questions about whether I had a girlfriend, and what I did over the weekend. At Berkeley High my openness wasn’t an issue at all. The school had a vibrant Gay Straight Alliance/GSA for years, there were many openly gay staff and many openly gay students. No students felt the need to come out to me in search of a gay mentor.

Two years later, I began teaching in San Leandro, 20 miles away, and it was a lesson in how even the San Francisco Bay Area, an LGBTQ+ bastion, could harbor homophobia. When I was hired in 2003, San Leandro High had one openly gay teacher, Q. I quickly realized how much braver his coming out was compared with mine in Berkeley.

In San Leandro, gay slurs were heard nonstop in the hallways, no students were out, and by the end of my first year Q had quit, confiding in me that he couldn’t handle the homophobic harassment from students anymore. There was no GSA. A few years ago, two lesbians had held hands during lunch and inspired the wrath of a group of parents who advocated for their expulsion. In response, a teacher tried to introduce gay sensitivity training into his class and the same group of parents tried to get him fired. He was reprimanded by the principal, he countersued in a case that went all the way to the California Supreme Court, and won. Comparing these two local high schools reinforced to me how visibility really matters in creating a childhood experience that is nurturing versus traumatizing.¹

Two Chinese girls in love

N and T were two Chinese girls who grew up in San Leandro. They went to the same elementary school and had crushes on each other since then. In their junior year, they joined our first student GSA, becoming president and vice-president. They were out. And, of course, they must’ve known that their families, who would not have been supportive, would become aware. I remember sitting at an outdoor concert when I got a text from N warning me her father had found out and blamed me for having corrupted her. He planned on coming to school to demand I be fired. And such was the unrelenting pressure that N and T faced every time they went home from school and sat at their dinner tables. Eventually, they broke up. They didn’t do so tearfully, but more wearily.

This story illustrates how difficult it is for love between two LGBTQ+ teens to be nurtured. Love in youth can already be volatile because of the lack of emotional regulation and experience. The questioning of identity and the threat of family disintegration at a time when these teens do not have the economic means to protect themselves makes love dangerous. It is no wonder that gay teens are at increased risk for homelessness.²

The family incident that led to the girls’ breakup reveals how culture affects homophobic pressure. N resisted her parents’ disapproval for months, but she capitulated when her father had a heart attack and blamed it on her. “And it’s true,” N confided. “After my parents found out, they were continually stressed. I could see it affect their health. And it breaks my heart to see my dad in the hospital.”

For N, she had not capitulated from fear, but perhaps because of filial piety, or one’s obligation to protect one’s parent. It was a choice between two heartbreaks. Double minorities, like N and T, face a double threat and often can find no safe place. One of my patients who is gay and Black put it best: “It’s like being beaten up at school only to come home to another beating.” This double threat is evidenced by the higher suicide risk of ethnicities who are LGBTQ+ relative to their white counterparts.³

The confusion of a gay athlete

R was a star point guard, a senior who had secured an athletic scholarship, and was recognized as the best athlete in our county. A popular boy, he flaunted his physique and flirted with all the girls. And then when he was enrolled in my class, he began flirting with all the boys, too. There was gossip that R was bisexual. Then one day, not unexpectedly, he came out to me as gay. He admitted he only flirted with girls for his reputation.

By this time many students had come out to me but he flirted with me with his revelation. I corrected him and warned him unequivocally that it was inappropriate but I was worried because I knew he had placed his trust in me. I also knew he came from a homophobic family that was violent – his father had attacked him physically at a school game and our coaches had to pull him off.

Instinctively, I felt I had to have a witness so I confided in another teacher and documented the situation meticulously. Then, one day, just as I feared, he went too far. He stayed after class and said he wanted to show me something on his phone. And that something turned out to be a picture of himself naked. I immediately confiscated the phone and reported it to the administration. This was not how I wanted him to come out: His family notified by the police that he had sexually harassed his teacher, expulsion pending, and scholarship inevitably revoked. Fortunately, we did find a resolution that restored R’s future.

Let’s examine the circumstances that could’ve informed his transgressive behavior. If we consider sexual harassment a form of bullying, R’s history of having a father who publicly bullied him – and may have bullied others in front of him – is a known risk factor.⁴ It is also common knowledge that organized team sports were and still are a bastion of homophobia and that gay athletes had to accept a culture of explicit homophobia.⁵

So, it is not hard to understand the constant public pressures that R faced in addition to those from his family. Let’s also consider that appropriate sexual behaviors are not something we are born with, but something that is learned. Of course, inappropriate sexual behavior also happens in the heterosexual world. But heterosexual sexual behavior often has more accepted paths of trial and error. Children experiment with these behaviors and are corrected by adults and older peers as they mature.

However, for homosexual behaviors, there is not usually the fine-tuning about what is appropriate.
 

Summary

An educational environment where LGBTQ+ persons are highly visible and accepted is a more nurturing environment for LGBTQ teens than one that is not. Specific subcultures within the LGBTQ population involving race, culture, gender, and athletics modulate the experience of coming out and the nature of homophobic oppression.

Dr. Nguyen is a first-year psychiatry resident at the University of San Francisco School of Medicine at Fresno.

References

1. Kosciw JG et al. The effect of negative school climate on academic outcomes for LGBT youth and the role of in-school supports. J Sch Violence. 2013;12(1):45-63.

2. Center for American Progress. Gay and Transgender Youth Homelessness by the Numbers. June 21, 2010).

3. O’Donnell S et al. Increased risk of suicide attempts among Black and Latino lesbians, gay men, and bisexuals. Am J Public Health. 2011;101(6):1055-9.

4. Farrington D and Baldry A. Individual risk factors for school bullying. J Aggress Confl Peace Res. 2010 Jan;2(1):4-16.

5. Anderson E. Openly gay athletes: Contesting hegemonic masculinity in a homophobic environment Gend Soc. 2002 Dec:16(6):860-77.

I am a psychiatrist now but had another life teaching English in public high school for 17 years. My teaching life, in which I was an openly gay teacher, spanned 2001-2018 and was divided between two urban California schools – in Berkeley and San Leandro. I came out by responding honestly to student questions about whether I had a girlfriend, and what I did over the weekend. At Berkeley High my openness wasn’t an issue at all. The school had a vibrant Gay Straight Alliance/GSA for years, there were many openly gay staff and many openly gay students. No students felt the need to come out to me in search of a gay mentor.

Two years later, I began teaching in San Leandro, 20 miles away, and it was a lesson in how even the San Francisco Bay Area, an LGBTQ+ bastion, could harbor homophobia. When I was hired in 2003, San Leandro High had one openly gay teacher, Q. I quickly realized how much braver his coming out was compared with mine in Berkeley.

In San Leandro, gay slurs were heard nonstop in the hallways, no students were out, and by the end of my first year Q had quit, confiding in me that he couldn’t handle the homophobic harassment from students anymore. There was no GSA. A few years ago, two lesbians had held hands during lunch and inspired the wrath of a group of parents who advocated for their expulsion. In response, a teacher tried to introduce gay sensitivity training into his class and the same group of parents tried to get him fired. He was reprimanded by the principal, he countersued in a case that went all the way to the California Supreme Court, and won. Comparing these two local high schools reinforced to me how visibility really matters in creating a childhood experience that is nurturing versus traumatizing.¹

Two Chinese girls in love

N and T were two Chinese girls who grew up in San Leandro. They went to the same elementary school and had crushes on each other since then. In their junior year, they joined our first student GSA, becoming president and vice-president. They were out. And, of course, they must’ve known that their families, who would not have been supportive, would become aware. I remember sitting at an outdoor concert when I got a text from N warning me her father had found out and blamed me for having corrupted her. He planned on coming to school to demand I be fired. And such was the unrelenting pressure that N and T faced every time they went home from school and sat at their dinner tables. Eventually, they broke up. They didn’t do so tearfully, but more wearily.

This story illustrates how difficult it is for love between two LGBTQ+ teens to be nurtured. Love in youth can already be volatile because of the lack of emotional regulation and experience. The questioning of identity and the threat of family disintegration at a time when these teens do not have the economic means to protect themselves makes love dangerous. It is no wonder that gay teens are at increased risk for homelessness.²

The family incident that led to the girls’ breakup reveals how culture affects homophobic pressure. N resisted her parents’ disapproval for months, but she capitulated when her father had a heart attack and blamed it on her. “And it’s true,” N confided. “After my parents found out, they were continually stressed. I could see it affect their health. And it breaks my heart to see my dad in the hospital.”

For N, she had not capitulated from fear, but perhaps because of filial piety, or one’s obligation to protect one’s parent. It was a choice between two heartbreaks. Double minorities, like N and T, face a double threat and often can find no safe place. One of my patients who is gay and Black put it best: “It’s like being beaten up at school only to come home to another beating.” This double threat is evidenced by the higher suicide risk of ethnicities who are LGBTQ+ relative to their white counterparts.³

The confusion of a gay athlete

R was a star point guard, a senior who had secured an athletic scholarship, and was recognized as the best athlete in our county. A popular boy, he flaunted his physique and flirted with all the girls. And then when he was enrolled in my class, he began flirting with all the boys, too. There was gossip that R was bisexual. Then one day, not unexpectedly, he came out to me as gay. He admitted he only flirted with girls for his reputation.

By this time many students had come out to me but he flirted with me with his revelation. I corrected him and warned him unequivocally that it was inappropriate but I was worried because I knew he had placed his trust in me. I also knew he came from a homophobic family that was violent – his father had attacked him physically at a school game and our coaches had to pull him off.

Instinctively, I felt I had to have a witness so I confided in another teacher and documented the situation meticulously. Then, one day, just as I feared, he went too far. He stayed after class and said he wanted to show me something on his phone. And that something turned out to be a picture of himself naked. I immediately confiscated the phone and reported it to the administration. This was not how I wanted him to come out: His family notified by the police that he had sexually harassed his teacher, expulsion pending, and scholarship inevitably revoked. Fortunately, we did find a resolution that restored R’s future.

Let’s examine the circumstances that could’ve informed his transgressive behavior. If we consider sexual harassment a form of bullying, R’s history of having a father who publicly bullied him – and may have bullied others in front of him – is a known risk factor.⁴ It is also common knowledge that organized team sports were and still are a bastion of homophobia and that gay athletes had to accept a culture of explicit homophobia.⁵

So, it is not hard to understand the constant public pressures that R faced in addition to those from his family. Let’s also consider that appropriate sexual behaviors are not something we are born with, but something that is learned. Of course, inappropriate sexual behavior also happens in the heterosexual world. But heterosexual sexual behavior often has more accepted paths of trial and error. Children experiment with these behaviors and are corrected by adults and older peers as they mature.

However, for homosexual behaviors, there is not usually the fine-tuning about what is appropriate.
 

Summary

An educational environment where LGBTQ+ persons are highly visible and accepted is a more nurturing environment for LGBTQ teens than one that is not. Specific subcultures within the LGBTQ population involving race, culture, gender, and athletics modulate the experience of coming out and the nature of homophobic oppression.

Dr. Nguyen is a first-year psychiatry resident at the University of San Francisco School of Medicine at Fresno.

References

1. Kosciw JG et al. The effect of negative school climate on academic outcomes for LGBT youth and the role of in-school supports. J Sch Violence. 2013;12(1):45-63.

2. Center for American Progress. Gay and Transgender Youth Homelessness by the Numbers. June 21, 2010).

3. O’Donnell S et al. Increased risk of suicide attempts among Black and Latino lesbians, gay men, and bisexuals. Am J Public Health. 2011;101(6):1055-9.

4. Farrington D and Baldry A. Individual risk factors for school bullying. J Aggress Confl Peace Res. 2010 Jan;2(1):4-16.

5. Anderson E. Openly gay athletes: Contesting hegemonic masculinity in a homophobic environment Gend Soc. 2002 Dec:16(6):860-77.

I am a psychiatrist now but had another life teaching English in public high school for 17 years. My teaching life, in which I was an openly gay teacher, spanned 2001-2018 and was divided between two urban California schools – in Berkeley and San Leandro. I came out by responding honestly to student questions about whether I had a girlfriend, and what I did over the weekend. At Berkeley High my openness wasn’t an issue at all. The school had a vibrant Gay Straight Alliance/GSA for years, there were many openly gay staff and many openly gay students. No students felt the need to come out to me in search of a gay mentor.

Two years later, I began teaching in San Leandro, 20 miles away, and it was a lesson in how even the San Francisco Bay Area, an LGBTQ+ bastion, could harbor homophobia. When I was hired in 2003, San Leandro High had one openly gay teacher, Q. I quickly realized how much braver his coming out was compared with mine in Berkeley.

In San Leandro, gay slurs were heard nonstop in the hallways, no students were out, and by the end of my first year Q had quit, confiding in me that he couldn’t handle the homophobic harassment from students anymore. There was no GSA. A few years ago, two lesbians had held hands during lunch and inspired the wrath of a group of parents who advocated for their expulsion. In response, a teacher tried to introduce gay sensitivity training into his class and the same group of parents tried to get him fired. He was reprimanded by the principal, he countersued in a case that went all the way to the California Supreme Court, and won. Comparing these two local high schools reinforced to me how visibility really matters in creating a childhood experience that is nurturing versus traumatizing.¹

Two Chinese girls in love

N and T were two Chinese girls who grew up in San Leandro. They went to the same elementary school and had crushes on each other since then. In their junior year, they joined our first student GSA, becoming president and vice-president. They were out. And, of course, they must’ve known that their families, who would not have been supportive, would become aware. I remember sitting at an outdoor concert when I got a text from N warning me her father had found out and blamed me for having corrupted her. He planned on coming to school to demand I be fired. And such was the unrelenting pressure that N and T faced every time they went home from school and sat at their dinner tables. Eventually, they broke up. They didn’t do so tearfully, but more wearily.

This story illustrates how difficult it is for love between two LGBTQ+ teens to be nurtured. Love in youth can already be volatile because of the lack of emotional regulation and experience. The questioning of identity and the threat of family disintegration at a time when these teens do not have the economic means to protect themselves makes love dangerous. It is no wonder that gay teens are at increased risk for homelessness.²

The family incident that led to the girls’ breakup reveals how culture affects homophobic pressure. N resisted her parents’ disapproval for months, but she capitulated when her father had a heart attack and blamed it on her. “And it’s true,” N confided. “After my parents found out, they were continually stressed. I could see it affect their health. And it breaks my heart to see my dad in the hospital.”

For N, she had not capitulated from fear, but perhaps because of filial piety, or one’s obligation to protect one’s parent. It was a choice between two heartbreaks. Double minorities, like N and T, face a double threat and often can find no safe place. One of my patients who is gay and Black put it best: “It’s like being beaten up at school only to come home to another beating.” This double threat is evidenced by the higher suicide risk of ethnicities who are LGBTQ+ relative to their white counterparts.³

The confusion of a gay athlete

R was a star point guard, a senior who had secured an athletic scholarship, and was recognized as the best athlete in our county. A popular boy, he flaunted his physique and flirted with all the girls. And then when he was enrolled in my class, he began flirting with all the boys, too. There was gossip that R was bisexual. Then one day, not unexpectedly, he came out to me as gay. He admitted he only flirted with girls for his reputation.

By this time many students had come out to me but he flirted with me with his revelation. I corrected him and warned him unequivocally that it was inappropriate but I was worried because I knew he had placed his trust in me. I also knew he came from a homophobic family that was violent – his father had attacked him physically at a school game and our coaches had to pull him off.

Instinctively, I felt I had to have a witness so I confided in another teacher and documented the situation meticulously. Then, one day, just as I feared, he went too far. He stayed after class and said he wanted to show me something on his phone. And that something turned out to be a picture of himself naked. I immediately confiscated the phone and reported it to the administration. This was not how I wanted him to come out: His family notified by the police that he had sexually harassed his teacher, expulsion pending, and scholarship inevitably revoked. Fortunately, we did find a resolution that restored R’s future.

Let’s examine the circumstances that could’ve informed his transgressive behavior. If we consider sexual harassment a form of bullying, R’s history of having a father who publicly bullied him – and may have bullied others in front of him – is a known risk factor.⁴ It is also common knowledge that organized team sports were and still are a bastion of homophobia and that gay athletes had to accept a culture of explicit homophobia.⁵

So, it is not hard to understand the constant public pressures that R faced in addition to those from his family. Let’s also consider that appropriate sexual behaviors are not something we are born with, but something that is learned. Of course, inappropriate sexual behavior also happens in the heterosexual world. But heterosexual sexual behavior often has more accepted paths of trial and error. Children experiment with these behaviors and are corrected by adults and older peers as they mature.

However, for homosexual behaviors, there is not usually the fine-tuning about what is appropriate.
 

Summary

An educational environment where LGBTQ+ persons are highly visible and accepted is a more nurturing environment for LGBTQ teens than one that is not. Specific subcultures within the LGBTQ population involving race, culture, gender, and athletics modulate the experience of coming out and the nature of homophobic oppression.

Dr. Nguyen is a first-year psychiatry resident at the University of San Francisco School of Medicine at Fresno.

References

1. Kosciw JG et al. The effect of negative school climate on academic outcomes for LGBT youth and the role of in-school supports. J Sch Violence. 2013;12(1):45-63.

2. Center for American Progress. Gay and Transgender Youth Homelessness by the Numbers. June 21, 2010).

3. O’Donnell S et al. Increased risk of suicide attempts among Black and Latino lesbians, gay men, and bisexuals. Am J Public Health. 2011;101(6):1055-9.

4. Farrington D and Baldry A. Individual risk factors for school bullying. J Aggress Confl Peace Res. 2010 Jan;2(1):4-16.

5. Anderson E. Openly gay athletes: Contesting hegemonic masculinity in a homophobic environment Gend Soc. 2002 Dec:16(6):860-77.

HONOLULU – A new option for treating scabies, topical spinosad marks a significant development in the scabies treatment landscape, Anthony J. Mancini, MD, said during a presentation at the Hawaii Dermatology Seminar provided by MedscapeLIVE!

In April 2021, spinosad topical suspension 0.9%, was approved by the Food and Drug Administration for treating scabies infestations in adult and pediatric patients 4 years of age and older – a first-in-class drug and the first new scabicide approved in 31 years. It was also approved for treating head lice in adults and children aged 6 months of age and older.

Dr. Anthony J. Mancini

“Scabies has been described as the worst itch one can experience,” said Dr. Mancini, professor of pediatrics and dermatology at Northwestern University, Chicago. “It’s a hallmark of the disease, it can persist for weeks, it’s most intense at night, and patients report various sensations. It’s believed to be a both type I and type IV hypersensitivity reaction.”

The microscopic scabies mite burrows into the upper layer of the skin where it lives and lays its eggs. Besides intense itching, the classic presentation consists of a skin rash composed of inflammatory papules, linear burrows and crusted papules (especially on the hands, feet, and groin), and at times, larger red nodules. “Scabies nodules can persist for many months,” he said.

The Global Burden of Disease Study 2015 cited scabies as having the greatest burden of disease in tropical regions, especially among children, adolescents, and the elderly. The greatest burden of disability-adjusted life years (DALYs) occurred in East and Southeast Asia, Oceana, and tropical South America, but in North America, there was a 24% increase in the DALY rate between 1990 and 2015.

In addition, the World Health Organization designated scabies as a neglected tropical disease in 2017 and included it in its 10-year road map for neglected tropical diseases 2021-2030 with goals of promoting disease awareness and encouraging research and achieving global control.

Dr. Anthony Mancini

“In our country, we typically see scabies treated successfully without complications, but there can be complications, especially in underdeveloped areas, like Staph aureus and Group A beta-hemolytic streptococcal infections,” which can be fatal, said Dr. Mancini, who is also head of pediatric dermatology at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Permethrin 5% cream is typically offered as first-line topical therapy in the United States for the treatment of scabies. However, in vitro studies and small investigator-initiated in vivo studies have reported that efficacy appears to be decreasing. In one of the trials, Italian researchers enrolled 155 patients who were treated with permethrin 5% for 8 hours for 2 consecutive days and repeated the treatment 5 days later (J Eur Acad Dermatol Venereol. 2021;35[12]:e889-91). Following the course of permethrin, only 34 responded, 96 failed treatment, and 25 were lost to follow-up.

“The study authors concluded that mite resistance to permethrin 5% seems to be increasing, following a path like other ectoparasite resistance,” said Dr. Mancini, who was not involved with the study. “We may even be seeing more ivermectin resistance in some geographic locations, as well.”

According to new scabicide efficacy criteria established by the FDA in 2016, complete cure is now defined as meeting both clinical and confirmatory criteria. A clinical cure means that all signs and symptoms of scabies have completely resolved, including burrows, inflammatory/noninflammatory lesions, and pruritus. A confirmatory cure means there is an absence of mites, eggs, scybala (feces), and burrows via microscopy or dermoscopy.

Dr. Anthony J. Mancini

Enter spinosad, which is derived from a naturally occurring soil microorganism known as Saccharopolyspora spinosa and is composed of two active molecules: spinosyn A and spinosyn D. According to Dr. Mancini, spinosad’s mechanism of action is unique from other medications used to treat ectoparasites. It activates nicotinic and GABA-gated sodium channels, leads to sodium influx in the insect nerves, hyperexcitation, then paralysis and death. Cross-resistance to other insecticides has not been reported, he added, and there is no known evidence of resistance to its active compound.

Approval of the drug was based on data from two phase 3 randomized clinical trials involving 551 index cases and household contacts. In the intent-to-treat population, with the two trials combined, complete cure was achieved in 78.1% of the spinosad-treated group, compared with 39.6% in the vehicle group (P < .0001), clinical cure was achieved in 79.6% of the spinosad group, compared with 41.2% in the vehicle group (P < .001), and microscopic cure occurred in 85.9% of the spinosad group, compared with 52.6% in the vehicle group (P < .001).

Of the 306 participants in the study, the only adverse events reported by more than one patient each included abdominal pain, back pain, cough, headache, neck pain, and decreased weight in two patients each (0.8%), which investigators believed were not attributable to the study drug. Adverse events that investigators considered to be potentially related to the study drug included burning sensation in two participants (0.7%) and dry skin in another (0.3%). In clinical trials reported in the prescribing information, adverse events occurring in greater than 1% of subjects included application-site irritation (3% spinosad vs. 0% vehicle) and dry skin (2% spinosad vs. 0% vehicle).

“Spinosad met the FDA’s new stringent criteria, with all signs and symptoms of scabies completely resolved and confirmed via microscopy or dermoscopy,” said Dr. Mancini, who was not involved in the trials. “The patented formulation drives the active compound to the stratum corneum, where mites live and breed. It’s a single full-body application, without any resistance observed to date. This is an exciting newer option for treating our scabies patients.”

In an interview at the meeting, John S. Barbieri, MD, MBA, of the department of dermatology, Brigham and Women’s Hospital, Boston, said that, while he has no clinical experience with spinosad for scabies, he welcomes a new option for the condition. “The fact that it has a different mechanism of action than permethrin is a good thing,” he said.

Dr. Mancini disclosed that he is a consultant or an adviser for ParaPRO, the manufacturer of spinosad, and Cassiopea, Castle Creek, Novan, Novartis, and Verrica. He was not involved in clinical trials of spinosad. Dr. Barbieri disclosed that he receives consulting fees from Dexcel.

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

HONOLULU – A new option for treating scabies, topical spinosad marks a significant development in the scabies treatment landscape, Anthony J. Mancini, MD, said during a presentation at the Hawaii Dermatology Seminar provided by MedscapeLIVE!

In April 2021, spinosad topical suspension 0.9%, was approved by the Food and Drug Administration for treating scabies infestations in adult and pediatric patients 4 years of age and older – a first-in-class drug and the first new scabicide approved in 31 years. It was also approved for treating head lice in adults and children aged 6 months of age and older.

Dr. Anthony J. Mancini

“Scabies has been described as the worst itch one can experience,” said Dr. Mancini, professor of pediatrics and dermatology at Northwestern University, Chicago. “It’s a hallmark of the disease, it can persist for weeks, it’s most intense at night, and patients report various sensations. It’s believed to be a both type I and type IV hypersensitivity reaction.”

The microscopic scabies mite burrows into the upper layer of the skin where it lives and lays its eggs. Besides intense itching, the classic presentation consists of a skin rash composed of inflammatory papules, linear burrows and crusted papules (especially on the hands, feet, and groin), and at times, larger red nodules. “Scabies nodules can persist for many months,” he said.

The Global Burden of Disease Study 2015 cited scabies as having the greatest burden of disease in tropical regions, especially among children, adolescents, and the elderly. The greatest burden of disability-adjusted life years (DALYs) occurred in East and Southeast Asia, Oceana, and tropical South America, but in North America, there was a 24% increase in the DALY rate between 1990 and 2015.

In addition, the World Health Organization designated scabies as a neglected tropical disease in 2017 and included it in its 10-year road map for neglected tropical diseases 2021-2030 with goals of promoting disease awareness and encouraging research and achieving global control.

Dr. Anthony Mancini

“In our country, we typically see scabies treated successfully without complications, but there can be complications, especially in underdeveloped areas, like Staph aureus and Group A beta-hemolytic streptococcal infections,” which can be fatal, said Dr. Mancini, who is also head of pediatric dermatology at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Permethrin 5% cream is typically offered as first-line topical therapy in the United States for the treatment of scabies. However, in vitro studies and small investigator-initiated in vivo studies have reported that efficacy appears to be decreasing. In one of the trials, Italian researchers enrolled 155 patients who were treated with permethrin 5% for 8 hours for 2 consecutive days and repeated the treatment 5 days later (J Eur Acad Dermatol Venereol. 2021;35[12]:e889-91). Following the course of permethrin, only 34 responded, 96 failed treatment, and 25 were lost to follow-up.

“The study authors concluded that mite resistance to permethrin 5% seems to be increasing, following a path like other ectoparasite resistance,” said Dr. Mancini, who was not involved with the study. “We may even be seeing more ivermectin resistance in some geographic locations, as well.”

According to new scabicide efficacy criteria established by the FDA in 2016, complete cure is now defined as meeting both clinical and confirmatory criteria. A clinical cure means that all signs and symptoms of scabies have completely resolved, including burrows, inflammatory/noninflammatory lesions, and pruritus. A confirmatory cure means there is an absence of mites, eggs, scybala (feces), and burrows via microscopy or dermoscopy.

Dr. Anthony J. Mancini

Enter spinosad, which is derived from a naturally occurring soil microorganism known as Saccharopolyspora spinosa and is composed of two active molecules: spinosyn A and spinosyn D. According to Dr. Mancini, spinosad’s mechanism of action is unique from other medications used to treat ectoparasites. It activates nicotinic and GABA-gated sodium channels, leads to sodium influx in the insect nerves, hyperexcitation, then paralysis and death. Cross-resistance to other insecticides has not been reported, he added, and there is no known evidence of resistance to its active compound.

Approval of the drug was based on data from two phase 3 randomized clinical trials involving 551 index cases and household contacts. In the intent-to-treat population, with the two trials combined, complete cure was achieved in 78.1% of the spinosad-treated group, compared with 39.6% in the vehicle group (P < .0001), clinical cure was achieved in 79.6% of the spinosad group, compared with 41.2% in the vehicle group (P < .001), and microscopic cure occurred in 85.9% of the spinosad group, compared with 52.6% in the vehicle group (P < .001).

Of the 306 participants in the study, the only adverse events reported by more than one patient each included abdominal pain, back pain, cough, headache, neck pain, and decreased weight in two patients each (0.8%), which investigators believed were not attributable to the study drug. Adverse events that investigators considered to be potentially related to the study drug included burning sensation in two participants (0.7%) and dry skin in another (0.3%). In clinical trials reported in the prescribing information, adverse events occurring in greater than 1% of subjects included application-site irritation (3% spinosad vs. 0% vehicle) and dry skin (2% spinosad vs. 0% vehicle).

“Spinosad met the FDA’s new stringent criteria, with all signs and symptoms of scabies completely resolved and confirmed via microscopy or dermoscopy,” said Dr. Mancini, who was not involved in the trials. “The patented formulation drives the active compound to the stratum corneum, where mites live and breed. It’s a single full-body application, without any resistance observed to date. This is an exciting newer option for treating our scabies patients.”

In an interview at the meeting, John S. Barbieri, MD, MBA, of the department of dermatology, Brigham and Women’s Hospital, Boston, said that, while he has no clinical experience with spinosad for scabies, he welcomes a new option for the condition. “The fact that it has a different mechanism of action than permethrin is a good thing,” he said.

Dr. Mancini disclosed that he is a consultant or an adviser for ParaPRO, the manufacturer of spinosad, and Cassiopea, Castle Creek, Novan, Novartis, and Verrica. He was not involved in clinical trials of spinosad. Dr. Barbieri disclosed that he receives consulting fees from Dexcel.

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

HONOLULU – A new option for treating scabies, topical spinosad marks a significant development in the scabies treatment landscape, Anthony J. Mancini, MD, said during a presentation at the Hawaii Dermatology Seminar provided by MedscapeLIVE!

In April 2021, spinosad topical suspension 0.9%, was approved by the Food and Drug Administration for treating scabies infestations in adult and pediatric patients 4 years of age and older – a first-in-class drug and the first new scabicide approved in 31 years. It was also approved for treating head lice in adults and children aged 6 months of age and older.

Dr. Anthony J. Mancini

“Scabies has been described as the worst itch one can experience,” said Dr. Mancini, professor of pediatrics and dermatology at Northwestern University, Chicago. “It’s a hallmark of the disease, it can persist for weeks, it’s most intense at night, and patients report various sensations. It’s believed to be a both type I and type IV hypersensitivity reaction.”

The microscopic scabies mite burrows into the upper layer of the skin where it lives and lays its eggs. Besides intense itching, the classic presentation consists of a skin rash composed of inflammatory papules, linear burrows and crusted papules (especially on the hands, feet, and groin), and at times, larger red nodules. “Scabies nodules can persist for many months,” he said.

The Global Burden of Disease Study 2015 cited scabies as having the greatest burden of disease in tropical regions, especially among children, adolescents, and the elderly. The greatest burden of disability-adjusted life years (DALYs) occurred in East and Southeast Asia, Oceana, and tropical South America, but in North America, there was a 24% increase in the DALY rate between 1990 and 2015.

In addition, the World Health Organization designated scabies as a neglected tropical disease in 2017 and included it in its 10-year road map for neglected tropical diseases 2021-2030 with goals of promoting disease awareness and encouraging research and achieving global control.

Dr. Anthony Mancini

“In our country, we typically see scabies treated successfully without complications, but there can be complications, especially in underdeveloped areas, like Staph aureus and Group A beta-hemolytic streptococcal infections,” which can be fatal, said Dr. Mancini, who is also head of pediatric dermatology at Ann & Robert H. Lurie Children’s Hospital of Chicago.

Permethrin 5% cream is typically offered as first-line topical therapy in the United States for the treatment of scabies. However, in vitro studies and small investigator-initiated in vivo studies have reported that efficacy appears to be decreasing. In one of the trials, Italian researchers enrolled 155 patients who were treated with permethrin 5% for 8 hours for 2 consecutive days and repeated the treatment 5 days later (J Eur Acad Dermatol Venereol. 2021;35[12]:e889-91). Following the course of permethrin, only 34 responded, 96 failed treatment, and 25 were lost to follow-up.

“The study authors concluded that mite resistance to permethrin 5% seems to be increasing, following a path like other ectoparasite resistance,” said Dr. Mancini, who was not involved with the study. “We may even be seeing more ivermectin resistance in some geographic locations, as well.”

According to new scabicide efficacy criteria established by the FDA in 2016, complete cure is now defined as meeting both clinical and confirmatory criteria. A clinical cure means that all signs and symptoms of scabies have completely resolved, including burrows, inflammatory/noninflammatory lesions, and pruritus. A confirmatory cure means there is an absence of mites, eggs, scybala (feces), and burrows via microscopy or dermoscopy.

Dr. Anthony J. Mancini

Enter spinosad, which is derived from a naturally occurring soil microorganism known as Saccharopolyspora spinosa and is composed of two active molecules: spinosyn A and spinosyn D. According to Dr. Mancini, spinosad’s mechanism of action is unique from other medications used to treat ectoparasites. It activates nicotinic and GABA-gated sodium channels, leads to sodium influx in the insect nerves, hyperexcitation, then paralysis and death. Cross-resistance to other insecticides has not been reported, he added, and there is no known evidence of resistance to its active compound.

Approval of the drug was based on data from two phase 3 randomized clinical trials involving 551 index cases and household contacts. In the intent-to-treat population, with the two trials combined, complete cure was achieved in 78.1% of the spinosad-treated group, compared with 39.6% in the vehicle group (P < .0001), clinical cure was achieved in 79.6% of the spinosad group, compared with 41.2% in the vehicle group (P < .001), and microscopic cure occurred in 85.9% of the spinosad group, compared with 52.6% in the vehicle group (P < .001).

Of the 306 participants in the study, the only adverse events reported by more than one patient each included abdominal pain, back pain, cough, headache, neck pain, and decreased weight in two patients each (0.8%), which investigators believed were not attributable to the study drug. Adverse events that investigators considered to be potentially related to the study drug included burning sensation in two participants (0.7%) and dry skin in another (0.3%). In clinical trials reported in the prescribing information, adverse events occurring in greater than 1% of subjects included application-site irritation (3% spinosad vs. 0% vehicle) and dry skin (2% spinosad vs. 0% vehicle).

“Spinosad met the FDA’s new stringent criteria, with all signs and symptoms of scabies completely resolved and confirmed via microscopy or dermoscopy,” said Dr. Mancini, who was not involved in the trials. “The patented formulation drives the active compound to the stratum corneum, where mites live and breed. It’s a single full-body application, without any resistance observed to date. This is an exciting newer option for treating our scabies patients.”

In an interview at the meeting, John S. Barbieri, MD, MBA, of the department of dermatology, Brigham and Women’s Hospital, Boston, said that, while he has no clinical experience with spinosad for scabies, he welcomes a new option for the condition. “The fact that it has a different mechanism of action than permethrin is a good thing,” he said.

Dr. Mancini disclosed that he is a consultant or an adviser for ParaPRO, the manufacturer of spinosad, and Cassiopea, Castle Creek, Novan, Novartis, and Verrica. He was not involved in clinical trials of spinosad. Dr. Barbieri disclosed that he receives consulting fees from Dexcel.

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

Scenario: Yesterday you saw a 6-month-old infant with what appeared to be viral gastroenteritis and mild dehydration. When you called his parents today to check on his condition he was not improving despite your recommendations about his diet and oral rehydration. Should you have him brought to your office for a reevaluation, have his parents take him to the local emergency department for evaluation and probable hospital admission, or ask his parents to take him to the hospital telling them that you will call and arrange for a direct admission.

Obviously, I haven’t given you enough background information to allow you to give me an answer you are comfortable with. What time of day is it? Is it a holiday weekend? What’s the weather like? How far is it from the patient’s home to your office? To the emergency department? How is the local ED staffed? Are there hospitalists? What is their training?

Whether or not you choose to see the patient first in the office, is direct admission to the hospital an option that you are likely to choose? What steps do you take to see that it happens smoothly?

At least one-quarter of the unscheduled pediatric hospitalizations begin with a direct admission, meaning that the patients are not first evaluated in that hospital’s ED. In a recent policy statement, the American Academy of Pediatrics Committee on Hospital Care explored the pluses and minuses of direct admission and issued a list of seven recommendations. Among the concerns raised by the authors are “potential delays in initial evaluation and treatment, inconsistent admission processes, and difficulties in determining the appropriateness of patients for direct admission.” The committee makes it clear that they understand each community has it own strengths and challenges and the unique needs of each patient make it difficult to define a set of recommendations that fits all.

However, as I read through the committee’s seven recommendations, one leapt off the screen as a unifying concept that should apply in every situation. Recommendation No. 2 reads, “[There should be] clear systems of communication between members of the health care team and with families of children requiring admission.”

First, who is on this “health care team”? Are you a team member with the hospital folks – the ED nurses and doctors, the hospitalists, the floor nurses? Do you share an employer? Are you in the same town? Have your ever met them face to face? Do you do so regularly?

I assume you call the ED or the pediatric floor to arrange a direct admit? Maybe you don’t. I can recall working in situations where several infamous “local docs” would just send the patients in with a scribbled note (or not) and no phone call. Will you be speaking to folks who are even vaguely familiar with you or even your name? Do you get to speak with people who will be hands on with the patient?

Obviously, where I’m going with this is that, if you and the hospital staff are truly on the same health care team, communication should flow freely among the members and having some familiarity allows this to happen more smoothly. It can start on our end as the referring physician by making the call personally. Likewise, the receiving hospital must make frontline people available so you can speak with staff who will be working with the patient. Do you have enough information to tell the family what to expect?

Of course legible and complete records are a must. But nothing beats personal contact and a name. If you can tell a parent “I spoke to Martha, the nurse who will meet you on the floor,” that can be a giant first step forward in the healing process.

Most of us trained at hospitals that accepted direct admit patients and can remember the challenges. And most of us recall EDs that weren’t pediatric friendly. Whether our local situation favors direct admission or ED preadmission evaluation, it is our job to make the communication flow with the patient’s safety and the family’s comfort in mind.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Scenario: Yesterday you saw a 6-month-old infant with what appeared to be viral gastroenteritis and mild dehydration. When you called his parents today to check on his condition he was not improving despite your recommendations about his diet and oral rehydration. Should you have him brought to your office for a reevaluation, have his parents take him to the local emergency department for evaluation and probable hospital admission, or ask his parents to take him to the hospital telling them that you will call and arrange for a direct admission.

Obviously, I haven’t given you enough background information to allow you to give me an answer you are comfortable with. What time of day is it? Is it a holiday weekend? What’s the weather like? How far is it from the patient’s home to your office? To the emergency department? How is the local ED staffed? Are there hospitalists? What is their training?

Whether or not you choose to see the patient first in the office, is direct admission to the hospital an option that you are likely to choose? What steps do you take to see that it happens smoothly?

At least one-quarter of the unscheduled pediatric hospitalizations begin with a direct admission, meaning that the patients are not first evaluated in that hospital’s ED. In a recent policy statement, the American Academy of Pediatrics Committee on Hospital Care explored the pluses and minuses of direct admission and issued a list of seven recommendations. Among the concerns raised by the authors are “potential delays in initial evaluation and treatment, inconsistent admission processes, and difficulties in determining the appropriateness of patients for direct admission.” The committee makes it clear that they understand each community has it own strengths and challenges and the unique needs of each patient make it difficult to define a set of recommendations that fits all.

However, as I read through the committee’s seven recommendations, one leapt off the screen as a unifying concept that should apply in every situation. Recommendation No. 2 reads, “[There should be] clear systems of communication between members of the health care team and with families of children requiring admission.”

First, who is on this “health care team”? Are you a team member with the hospital folks – the ED nurses and doctors, the hospitalists, the floor nurses? Do you share an employer? Are you in the same town? Have your ever met them face to face? Do you do so regularly?

I assume you call the ED or the pediatric floor to arrange a direct admit? Maybe you don’t. I can recall working in situations where several infamous “local docs” would just send the patients in with a scribbled note (or not) and no phone call. Will you be speaking to folks who are even vaguely familiar with you or even your name? Do you get to speak with people who will be hands on with the patient?

Obviously, where I’m going with this is that, if you and the hospital staff are truly on the same health care team, communication should flow freely among the members and having some familiarity allows this to happen more smoothly. It can start on our end as the referring physician by making the call personally. Likewise, the receiving hospital must make frontline people available so you can speak with staff who will be working with the patient. Do you have enough information to tell the family what to expect?

Of course legible and complete records are a must. But nothing beats personal contact and a name. If you can tell a parent “I spoke to Martha, the nurse who will meet you on the floor,” that can be a giant first step forward in the healing process.

Most of us trained at hospitals that accepted direct admit patients and can remember the challenges. And most of us recall EDs that weren’t pediatric friendly. Whether our local situation favors direct admission or ED preadmission evaluation, it is our job to make the communication flow with the patient’s safety and the family’s comfort in mind.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Scenario: Yesterday you saw a 6-month-old infant with what appeared to be viral gastroenteritis and mild dehydration. When you called his parents today to check on his condition he was not improving despite your recommendations about his diet and oral rehydration. Should you have him brought to your office for a reevaluation, have his parents take him to the local emergency department for evaluation and probable hospital admission, or ask his parents to take him to the hospital telling them that you will call and arrange for a direct admission.

Obviously, I haven’t given you enough background information to allow you to give me an answer you are comfortable with. What time of day is it? Is it a holiday weekend? What’s the weather like? How far is it from the patient’s home to your office? To the emergency department? How is the local ED staffed? Are there hospitalists? What is their training?

Whether or not you choose to see the patient first in the office, is direct admission to the hospital an option that you are likely to choose? What steps do you take to see that it happens smoothly?

At least one-quarter of the unscheduled pediatric hospitalizations begin with a direct admission, meaning that the patients are not first evaluated in that hospital’s ED. In a recent policy statement, the American Academy of Pediatrics Committee on Hospital Care explored the pluses and minuses of direct admission and issued a list of seven recommendations. Among the concerns raised by the authors are “potential delays in initial evaluation and treatment, inconsistent admission processes, and difficulties in determining the appropriateness of patients for direct admission.” The committee makes it clear that they understand each community has it own strengths and challenges and the unique needs of each patient make it difficult to define a set of recommendations that fits all.

However, as I read through the committee’s seven recommendations, one leapt off the screen as a unifying concept that should apply in every situation. Recommendation No. 2 reads, “[There should be] clear systems of communication between members of the health care team and with families of children requiring admission.”

First, who is on this “health care team”? Are you a team member with the hospital folks – the ED nurses and doctors, the hospitalists, the floor nurses? Do you share an employer? Are you in the same town? Have your ever met them face to face? Do you do so regularly?

I assume you call the ED or the pediatric floor to arrange a direct admit? Maybe you don’t. I can recall working in situations where several infamous “local docs” would just send the patients in with a scribbled note (or not) and no phone call. Will you be speaking to folks who are even vaguely familiar with you or even your name? Do you get to speak with people who will be hands on with the patient?

Obviously, where I’m going with this is that, if you and the hospital staff are truly on the same health care team, communication should flow freely among the members and having some familiarity allows this to happen more smoothly. It can start on our end as the referring physician by making the call personally. Likewise, the receiving hospital must make frontline people available so you can speak with staff who will be working with the patient. Do you have enough information to tell the family what to expect?

Of course legible and complete records are a must. But nothing beats personal contact and a name. If you can tell a parent “I spoke to Martha, the nurse who will meet you on the floor,” that can be a giant first step forward in the healing process.

Most of us trained at hospitals that accepted direct admit patients and can remember the challenges. And most of us recall EDs that weren’t pediatric friendly. Whether our local situation favors direct admission or ED preadmission evaluation, it is our job to make the communication flow with the patient’s safety and the family’s comfort in mind.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Black children had almost three times as many COVID-related deaths as White children and about twice as many hospitalizations, according to a new study.

The study said that 1,556 children have died from the start of the pandemic until Nov. 30, 2022, with 593 of those children being 4 and under. Black children died of COVID-related causes 2.7 times more often than White children and were hospitalized 2.2 times more often than White children, the study said.

Lower vaccination rates for Black people may be a factor. The study said 43.6% of White children have received two or more vaccinations, compared with 40.2% of Black children.

“First and foremost, this study repudiates the misunderstanding that COVID-19 has not been of consequence to children who have had more than 15.5 million reported cases, representing 18 percent of all cases in the United States,” Reed Tuckson, MD, a member of the Black Coalition Against COVID board of directors and former District of Columbia public health commissioner, said in a news release.

“And second, our research shows that like their adult counterparts, Black and other children of color have shouldered more of the burden of COVID-19 than the White population.”

The study was commissioned by BCAC and conducted by the Satcher Health Leadership Institute of the Morehouse School of Medicine, Atlanta. It’s based on studies conducted by other agencies over 2 years.

Black and Hispanic children also had more severe COVID cases, the study said. Among 281 pediatric patients in New York, New Jersey, and Connecticut, 23.3% of severe cases were Black and 51% of severe cases were Hispanic. 

The study says 1 in 310 Black children lost a parent or caregiver to COVID between April 2020 and June 2012, compared with 1 in 738 White children.

Economic and health-related hardships were experienced by 31% of Black households, 29% of Latino households, and 16% of White households, the study said.

“Children with COVID-19 in communities of color were sicker, [were] hospitalized and died at higher rates than White children,” Sandra Harris-Hooker, the interim executive director at the Satcher Health Leadership Institute of Morehouse School, said in the release. “We can now fully understand the devastating impact the virus had on communities of color across generations.”

The study recommends several changes, such as modifying eligibility requirements for the Children’s Health Insurance Program to help more children who fall into coverage gaps and expanding the Child Tax Credit.

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

Black children had almost three times as many COVID-related deaths as White children and about twice as many hospitalizations, according to a new study.

The study said that 1,556 children have died from the start of the pandemic until Nov. 30, 2022, with 593 of those children being 4 and under. Black children died of COVID-related causes 2.7 times more often than White children and were hospitalized 2.2 times more often than White children, the study said.

Lower vaccination rates for Black people may be a factor. The study said 43.6% of White children have received two or more vaccinations, compared with 40.2% of Black children.

“First and foremost, this study repudiates the misunderstanding that COVID-19 has not been of consequence to children who have had more than 15.5 million reported cases, representing 18 percent of all cases in the United States,” Reed Tuckson, MD, a member of the Black Coalition Against COVID board of directors and former District of Columbia public health commissioner, said in a news release.

“And second, our research shows that like their adult counterparts, Black and other children of color have shouldered more of the burden of COVID-19 than the White population.”

The study was commissioned by BCAC and conducted by the Satcher Health Leadership Institute of the Morehouse School of Medicine, Atlanta. It’s based on studies conducted by other agencies over 2 years.

Black and Hispanic children also had more severe COVID cases, the study said. Among 281 pediatric patients in New York, New Jersey, and Connecticut, 23.3% of severe cases were Black and 51% of severe cases were Hispanic. 

The study says 1 in 310 Black children lost a parent or caregiver to COVID between April 2020 and June 2012, compared with 1 in 738 White children.

Economic and health-related hardships were experienced by 31% of Black households, 29% of Latino households, and 16% of White households, the study said.

“Children with COVID-19 in communities of color were sicker, [were] hospitalized and died at higher rates than White children,” Sandra Harris-Hooker, the interim executive director at the Satcher Health Leadership Institute of Morehouse School, said in the release. “We can now fully understand the devastating impact the virus had on communities of color across generations.”

The study recommends several changes, such as modifying eligibility requirements for the Children’s Health Insurance Program to help more children who fall into coverage gaps and expanding the Child Tax Credit.

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

Black children had almost three times as many COVID-related deaths as White children and about twice as many hospitalizations, according to a new study.

The study said that 1,556 children have died from the start of the pandemic until Nov. 30, 2022, with 593 of those children being 4 and under. Black children died of COVID-related causes 2.7 times more often than White children and were hospitalized 2.2 times more often than White children, the study said.

Lower vaccination rates for Black people may be a factor. The study said 43.6% of White children have received two or more vaccinations, compared with 40.2% of Black children.

“First and foremost, this study repudiates the misunderstanding that COVID-19 has not been of consequence to children who have had more than 15.5 million reported cases, representing 18 percent of all cases in the United States,” Reed Tuckson, MD, a member of the Black Coalition Against COVID board of directors and former District of Columbia public health commissioner, said in a news release.

“And second, our research shows that like their adult counterparts, Black and other children of color have shouldered more of the burden of COVID-19 than the White population.”

The study was commissioned by BCAC and conducted by the Satcher Health Leadership Institute of the Morehouse School of Medicine, Atlanta. It’s based on studies conducted by other agencies over 2 years.

Black and Hispanic children also had more severe COVID cases, the study said. Among 281 pediatric patients in New York, New Jersey, and Connecticut, 23.3% of severe cases were Black and 51% of severe cases were Hispanic. 

The study says 1 in 310 Black children lost a parent or caregiver to COVID between April 2020 and June 2012, compared with 1 in 738 White children.

Economic and health-related hardships were experienced by 31% of Black households, 29% of Latino households, and 16% of White households, the study said.

“Children with COVID-19 in communities of color were sicker, [were] hospitalized and died at higher rates than White children,” Sandra Harris-Hooker, the interim executive director at the Satcher Health Leadership Institute of Morehouse School, said in the release. “We can now fully understand the devastating impact the virus had on communities of color across generations.”

The study recommends several changes, such as modifying eligibility requirements for the Children’s Health Insurance Program to help more children who fall into coverage gaps and expanding the Child Tax Credit.

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

The Food and Drug Administration has approved trofinetide oral solution (Daybue, Acadia Pharmaceuticals) as the first treatment of Rett syndrome in adults and children aged 2 years and older.

Rett syndrome is a rare, genetic neurodevelopmental disorder that affects about 6,000-9,000 people in the United States, mostly females.

Symptoms typically present between 6 and 18 months of age, with patients experiencing a rapid decline with loss of fine motor and communication skills.

Olivier Le Moal/Getty Images

Trofinetide is a synthetic analogue of the amino-terminal tripeptide of insulinlike growth factor-1 (IGF-1), which occurs naturally in the brain. The drug is designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.

The approval of trofinetide was supported by results from the pivotal phase 3 LAVENDER study that tested the efficacy and safety of trofinetide vs. placebo in 187 female patients with Rett syndrome, aged 5-20 years. 

A total of 93 participants were randomly assigned to twice-daily oral trofinetide, and 94 received placebo for 12 weeks.

After 12 weeks, trofinetide showed a statistically significant improvement from baseline, compared with placebo, on both the caregiver-assessed Rett Syndrome Behavior Questionnaire (RSBQ) and 7-point Clinical Global Impression-Improvement (CGI-I) scale. 

The drug also outperformed placebo at 12 weeks in a key secondary endpoint: the composite score on the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist-Social (CSBS-DP-IT Social), a scale on which caregivers assess nonverbal communication.

The most common adverse events with trofinetide treatment were diarrhea and vomiting. Almost all these events were considered mild or moderate.

‘Historic day’

“This is a historic day for the Rett syndrome community and a meaningful moment for the patients and caregivers who have eagerly awaited the arrival of an approved treatment for this condition,” Melissa Kennedy, MHA, chief executive officer of the International Rett Syndrome Foundation, said in a news release issued by Acadia.

“Rett syndrome is a complicated, devastating disease that affects not only the individual patient, but whole families. With today’s FDA decision, those impacted by Rett have a promising new treatment option that has demonstrated benefit across a variety of Rett symptoms, including those that impact the daily lives of those living with Rett and their loved ones,” Ms. Kennedy said.

Trofinetide is expected to be available in the United States by the end of April.

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

The Food and Drug Administration has approved trofinetide oral solution (Daybue, Acadia Pharmaceuticals) as the first treatment of Rett syndrome in adults and children aged 2 years and older.

Rett syndrome is a rare, genetic neurodevelopmental disorder that affects about 6,000-9,000 people in the United States, mostly females.

Symptoms typically present between 6 and 18 months of age, with patients experiencing a rapid decline with loss of fine motor and communication skills.

Olivier Le Moal/Getty Images

Trofinetide is a synthetic analogue of the amino-terminal tripeptide of insulinlike growth factor-1 (IGF-1), which occurs naturally in the brain. The drug is designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.

The approval of trofinetide was supported by results from the pivotal phase 3 LAVENDER study that tested the efficacy and safety of trofinetide vs. placebo in 187 female patients with Rett syndrome, aged 5-20 years. 

A total of 93 participants were randomly assigned to twice-daily oral trofinetide, and 94 received placebo for 12 weeks.

After 12 weeks, trofinetide showed a statistically significant improvement from baseline, compared with placebo, on both the caregiver-assessed Rett Syndrome Behavior Questionnaire (RSBQ) and 7-point Clinical Global Impression-Improvement (CGI-I) scale. 

The drug also outperformed placebo at 12 weeks in a key secondary endpoint: the composite score on the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist-Social (CSBS-DP-IT Social), a scale on which caregivers assess nonverbal communication.

The most common adverse events with trofinetide treatment were diarrhea and vomiting. Almost all these events were considered mild or moderate.

‘Historic day’

“This is a historic day for the Rett syndrome community and a meaningful moment for the patients and caregivers who have eagerly awaited the arrival of an approved treatment for this condition,” Melissa Kennedy, MHA, chief executive officer of the International Rett Syndrome Foundation, said in a news release issued by Acadia.

“Rett syndrome is a complicated, devastating disease that affects not only the individual patient, but whole families. With today’s FDA decision, those impacted by Rett have a promising new treatment option that has demonstrated benefit across a variety of Rett symptoms, including those that impact the daily lives of those living with Rett and their loved ones,” Ms. Kennedy said.

Trofinetide is expected to be available in the United States by the end of April.

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

The Food and Drug Administration has approved trofinetide oral solution (Daybue, Acadia Pharmaceuticals) as the first treatment of Rett syndrome in adults and children aged 2 years and older.

Rett syndrome is a rare, genetic neurodevelopmental disorder that affects about 6,000-9,000 people in the United States, mostly females.

Symptoms typically present between 6 and 18 months of age, with patients experiencing a rapid decline with loss of fine motor and communication skills.

Olivier Le Moal/Getty Images

Trofinetide is a synthetic analogue of the amino-terminal tripeptide of insulinlike growth factor-1 (IGF-1), which occurs naturally in the brain. The drug is designed to treat the core symptoms of Rett syndrome by potentially reducing neuroinflammation and supporting synaptic function.

The approval of trofinetide was supported by results from the pivotal phase 3 LAVENDER study that tested the efficacy and safety of trofinetide vs. placebo in 187 female patients with Rett syndrome, aged 5-20 years. 

A total of 93 participants were randomly assigned to twice-daily oral trofinetide, and 94 received placebo for 12 weeks.

After 12 weeks, trofinetide showed a statistically significant improvement from baseline, compared with placebo, on both the caregiver-assessed Rett Syndrome Behavior Questionnaire (RSBQ) and 7-point Clinical Global Impression-Improvement (CGI-I) scale. 

The drug also outperformed placebo at 12 weeks in a key secondary endpoint: the composite score on the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist-Social (CSBS-DP-IT Social), a scale on which caregivers assess nonverbal communication.

The most common adverse events with trofinetide treatment were diarrhea and vomiting. Almost all these events were considered mild or moderate.

‘Historic day’

“This is a historic day for the Rett syndrome community and a meaningful moment for the patients and caregivers who have eagerly awaited the arrival of an approved treatment for this condition,” Melissa Kennedy, MHA, chief executive officer of the International Rett Syndrome Foundation, said in a news release issued by Acadia.

“Rett syndrome is a complicated, devastating disease that affects not only the individual patient, but whole families. With today’s FDA decision, those impacted by Rett have a promising new treatment option that has demonstrated benefit across a variety of Rett symptoms, including those that impact the daily lives of those living with Rett and their loved ones,” Ms. Kennedy said.

Trofinetide is expected to be available in the United States by the end of April.

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