User login
Liquid albuterol shortage effects reduced by alternative drugs, similar shortages may be increasingly common
The shortage of 0.5% albuterol sulfate inhalation solution, first reported by the FDA last October, gained increasing attention earlier this month when Akorn Pharmaceuticals – one of just two companies making the product – shut down after years of financial and regulatory troubles.
The other manufacturer, Nephron Pharmaceuticals, is producing 0.5% albuterol “as fast as possible” to overcome the shortage, CEO Lou Kennedy said in a written comment.
Meanwhile, the more commonly used version of liquid albuterol, with a concentration of 0.083%, remains in “good supply from several manufacturers,” according to an FDA spokesperson.
Still, headlines concerning the shortage have caused “a bit of a panic” for patients with asthma and parents with asthmatic children, according to David R. Stukus, MD, professor of clinical pediatrics in the division of allergy and immunology at Nationwide Children’s, Columbus, Ohio.
Much of the media coverage has lacked context, causing unnecessary worry, he said, as the shortage only affects one type of albuterol generally reserved for inpatient and emergency use.
“The shortage has not impacted our albuterol inhalers thus far,” Dr. Stukus said in an interview. “So I certainly don’t want people with asthma to panic that they’re going to run out of their inhaler anytime soon.”
Even infants and toddlers can use inhalers
Although Dr. Stukus noted that certain patients do require nebulizers, such as those with conditions that physically limit their breathing, like muscular dystrophy, most patients can use inhalers just fine. He said it’s a “pretty common misconception, even among medical professionals,” that infants and toddlers need nebulizers instead.
“In our institution, for example, we rarely ever start babies on a nebulizer when we diagnose them with asthma,” Dr. Stukus said. “We often just start right away with an inhaler with a spacer and a face mask.”
The shortage of liquid albuterol may therefore have a silver lining, he suggested, as it prompts clinicians to reconsider their routine practice.
“When situations like this arise, it’s a great opportunity for all of us to just take a step back and reevaluate the way we do things,” Dr. Stukus said. “Sometimes we just get caught up with inertia and we continue to do things the same way even though new options are available, or evidence has changed to the contrary.”
Nathan Rabinovitch, MD, professor of pediatrics in the division of pediatric allergy and clinical immunology at National Jewish Health, Denver, said that his center had trouble obtaining liquid albuterol about 2 weeks ago, so they pivoted to the more expensive levalbuterol for about a week and a half, until their albuterol supply was restored.
While Dr. Rabinovitch agreed that most children don’t need a nebulizer, he said about 5%-10% of kids with severe asthma should have one on hand in case their inhaler fails to control an exacerbation.
Personal preferences may also considered, he added.
“If [a parent] says, ‘I like to use the nebulizer. The kid likes it,’ I’m fine if they just use a nebulizer.”
One possible downside of relying on a nebulizer, however, is portability, according to Kelly O’Shea, MD, assistant professor in the division of allergy and clinical immunology at the University of Michigan, Ann Arbor.
“If you’re out at the park or out at a soccer game with your kids, and they are having trouble breathing ... and they need their albuterol, you don’t have that ability if you are tied to a nebulizer,” Dr. O’Shea said in an interview. “As long as a parent feels comfortable – they feel like [their child] can get deep breaths in, I agree that you can use [an inhaler] in the infant and toddler population.”
She also agreed that a nebulizer may serve as a kind of second step if an inhaler isn’t controlling an exacerbation; however, she emphasized that a nebulizer should not be considered a replacement for professional care, and should not give a false sense of security.
“I caution parents to make sure that when they need it, they also take the next step and head over to the emergency room,” Dr. O’Shea said.
Generic drug shortages becoming more common
While the present scarcity of liquid albuterol appears relatively mild in terms of clinical impact, it brings up broader concerns about generic drug supply, and why shortages like this are becoming more common, according to Katie J. Suda, PharmD, MS, professor of medicine and pharmacy, and associate director, center for pharmaceutical policy and prescribing at the University of Pittsburgh.
“Drug shortages continue to increase in frequency, and the duration and severity of the shortages are also getting worse,” Dr. Suda said in an interview.
The reasons for these shortages can be elusive, according to 2022 report by the American Society of Health-System Pharmacists, which found that more than half of shortages came with no explanation from manufacturers.
The same report showed that only 5% of shortages were due to a “business decision,” but this factor is likely more central than publicly stated.
A recent FDA analysis on drug shortages, for instance, lists “lack of incentives to produce less profitable drugs,” as the first “root cause,” and Dr. Suda agrees.
“It’s important that we have generic medicines to decrease costs to our health systems, as well as for our patients,” Dr. Suda said. “But frequently, with those generic products, the price is driven so low that it increases the risk of a shortage.”
The drive to maintain profit margins may motivate companies to cut corners in production, Dr. Suda explained. She emphasized that this connection is speculative, because motivations are effectively unknowable, but the rationale is supported by past and present shortages.
Akorn Pharmaceuticals, for example, received a warning letter from the FDA in 2019 because of a variety of manufacturing issues, including defective bottles, questionable data, and metal shavings on aseptic filling equipment.
When a manufacturer like Akorn fails, the effects can be far-reaching, Dr. Suda said, noting their broad catalog of agents. Beyond liquid albuterol, Akorn was producing cardiac drugs, antibiotics, vitamins, local anesthetics, eye products, and others.
Drug shortages cause “a significant strain on our health care system,” Dr. Suda said, and substituting other medications increases risk of medical errors.
Fortunately, the increasing number of drug shortages is not going unnoticed, according to Dr. Suda. The FDA and multiple other organizations, including the ASHP, American Medical Association, and National Academies of Sciences, Engineering, and Medicine, are all taking steps to ensure that essential medicines are in steady supply, including moves to gather more data from manufacturers.
“I hope that a lot of the efforts that are moving forward ... will help us decrease the impact of shortages on our patients,” Dr. Suda said.
Lou Kennedy is the CEO of Nephron Pharmaceuticals, which commercially produces liquid albuterol. The other interviewees disclosed no relevant conflicts of interest.
The shortage of 0.5% albuterol sulfate inhalation solution, first reported by the FDA last October, gained increasing attention earlier this month when Akorn Pharmaceuticals – one of just two companies making the product – shut down after years of financial and regulatory troubles.
The other manufacturer, Nephron Pharmaceuticals, is producing 0.5% albuterol “as fast as possible” to overcome the shortage, CEO Lou Kennedy said in a written comment.
Meanwhile, the more commonly used version of liquid albuterol, with a concentration of 0.083%, remains in “good supply from several manufacturers,” according to an FDA spokesperson.
Still, headlines concerning the shortage have caused “a bit of a panic” for patients with asthma and parents with asthmatic children, according to David R. Stukus, MD, professor of clinical pediatrics in the division of allergy and immunology at Nationwide Children’s, Columbus, Ohio.
Much of the media coverage has lacked context, causing unnecessary worry, he said, as the shortage only affects one type of albuterol generally reserved for inpatient and emergency use.
“The shortage has not impacted our albuterol inhalers thus far,” Dr. Stukus said in an interview. “So I certainly don’t want people with asthma to panic that they’re going to run out of their inhaler anytime soon.”
Even infants and toddlers can use inhalers
Although Dr. Stukus noted that certain patients do require nebulizers, such as those with conditions that physically limit their breathing, like muscular dystrophy, most patients can use inhalers just fine. He said it’s a “pretty common misconception, even among medical professionals,” that infants and toddlers need nebulizers instead.
“In our institution, for example, we rarely ever start babies on a nebulizer when we diagnose them with asthma,” Dr. Stukus said. “We often just start right away with an inhaler with a spacer and a face mask.”
The shortage of liquid albuterol may therefore have a silver lining, he suggested, as it prompts clinicians to reconsider their routine practice.
“When situations like this arise, it’s a great opportunity for all of us to just take a step back and reevaluate the way we do things,” Dr. Stukus said. “Sometimes we just get caught up with inertia and we continue to do things the same way even though new options are available, or evidence has changed to the contrary.”
Nathan Rabinovitch, MD, professor of pediatrics in the division of pediatric allergy and clinical immunology at National Jewish Health, Denver, said that his center had trouble obtaining liquid albuterol about 2 weeks ago, so they pivoted to the more expensive levalbuterol for about a week and a half, until their albuterol supply was restored.
While Dr. Rabinovitch agreed that most children don’t need a nebulizer, he said about 5%-10% of kids with severe asthma should have one on hand in case their inhaler fails to control an exacerbation.
Personal preferences may also considered, he added.
“If [a parent] says, ‘I like to use the nebulizer. The kid likes it,’ I’m fine if they just use a nebulizer.”
One possible downside of relying on a nebulizer, however, is portability, according to Kelly O’Shea, MD, assistant professor in the division of allergy and clinical immunology at the University of Michigan, Ann Arbor.
“If you’re out at the park or out at a soccer game with your kids, and they are having trouble breathing ... and they need their albuterol, you don’t have that ability if you are tied to a nebulizer,” Dr. O’Shea said in an interview. “As long as a parent feels comfortable – they feel like [their child] can get deep breaths in, I agree that you can use [an inhaler] in the infant and toddler population.”
She also agreed that a nebulizer may serve as a kind of second step if an inhaler isn’t controlling an exacerbation; however, she emphasized that a nebulizer should not be considered a replacement for professional care, and should not give a false sense of security.
“I caution parents to make sure that when they need it, they also take the next step and head over to the emergency room,” Dr. O’Shea said.
Generic drug shortages becoming more common
While the present scarcity of liquid albuterol appears relatively mild in terms of clinical impact, it brings up broader concerns about generic drug supply, and why shortages like this are becoming more common, according to Katie J. Suda, PharmD, MS, professor of medicine and pharmacy, and associate director, center for pharmaceutical policy and prescribing at the University of Pittsburgh.
“Drug shortages continue to increase in frequency, and the duration and severity of the shortages are also getting worse,” Dr. Suda said in an interview.
The reasons for these shortages can be elusive, according to 2022 report by the American Society of Health-System Pharmacists, which found that more than half of shortages came with no explanation from manufacturers.
The same report showed that only 5% of shortages were due to a “business decision,” but this factor is likely more central than publicly stated.
A recent FDA analysis on drug shortages, for instance, lists “lack of incentives to produce less profitable drugs,” as the first “root cause,” and Dr. Suda agrees.
“It’s important that we have generic medicines to decrease costs to our health systems, as well as for our patients,” Dr. Suda said. “But frequently, with those generic products, the price is driven so low that it increases the risk of a shortage.”
The drive to maintain profit margins may motivate companies to cut corners in production, Dr. Suda explained. She emphasized that this connection is speculative, because motivations are effectively unknowable, but the rationale is supported by past and present shortages.
Akorn Pharmaceuticals, for example, received a warning letter from the FDA in 2019 because of a variety of manufacturing issues, including defective bottles, questionable data, and metal shavings on aseptic filling equipment.
When a manufacturer like Akorn fails, the effects can be far-reaching, Dr. Suda said, noting their broad catalog of agents. Beyond liquid albuterol, Akorn was producing cardiac drugs, antibiotics, vitamins, local anesthetics, eye products, and others.
Drug shortages cause “a significant strain on our health care system,” Dr. Suda said, and substituting other medications increases risk of medical errors.
Fortunately, the increasing number of drug shortages is not going unnoticed, according to Dr. Suda. The FDA and multiple other organizations, including the ASHP, American Medical Association, and National Academies of Sciences, Engineering, and Medicine, are all taking steps to ensure that essential medicines are in steady supply, including moves to gather more data from manufacturers.
“I hope that a lot of the efforts that are moving forward ... will help us decrease the impact of shortages on our patients,” Dr. Suda said.
Lou Kennedy is the CEO of Nephron Pharmaceuticals, which commercially produces liquid albuterol. The other interviewees disclosed no relevant conflicts of interest.
The shortage of 0.5% albuterol sulfate inhalation solution, first reported by the FDA last October, gained increasing attention earlier this month when Akorn Pharmaceuticals – one of just two companies making the product – shut down after years of financial and regulatory troubles.
The other manufacturer, Nephron Pharmaceuticals, is producing 0.5% albuterol “as fast as possible” to overcome the shortage, CEO Lou Kennedy said in a written comment.
Meanwhile, the more commonly used version of liquid albuterol, with a concentration of 0.083%, remains in “good supply from several manufacturers,” according to an FDA spokesperson.
Still, headlines concerning the shortage have caused “a bit of a panic” for patients with asthma and parents with asthmatic children, according to David R. Stukus, MD, professor of clinical pediatrics in the division of allergy and immunology at Nationwide Children’s, Columbus, Ohio.
Much of the media coverage has lacked context, causing unnecessary worry, he said, as the shortage only affects one type of albuterol generally reserved for inpatient and emergency use.
“The shortage has not impacted our albuterol inhalers thus far,” Dr. Stukus said in an interview. “So I certainly don’t want people with asthma to panic that they’re going to run out of their inhaler anytime soon.”
Even infants and toddlers can use inhalers
Although Dr. Stukus noted that certain patients do require nebulizers, such as those with conditions that physically limit their breathing, like muscular dystrophy, most patients can use inhalers just fine. He said it’s a “pretty common misconception, even among medical professionals,” that infants and toddlers need nebulizers instead.
“In our institution, for example, we rarely ever start babies on a nebulizer when we diagnose them with asthma,” Dr. Stukus said. “We often just start right away with an inhaler with a spacer and a face mask.”
The shortage of liquid albuterol may therefore have a silver lining, he suggested, as it prompts clinicians to reconsider their routine practice.
“When situations like this arise, it’s a great opportunity for all of us to just take a step back and reevaluate the way we do things,” Dr. Stukus said. “Sometimes we just get caught up with inertia and we continue to do things the same way even though new options are available, or evidence has changed to the contrary.”
Nathan Rabinovitch, MD, professor of pediatrics in the division of pediatric allergy and clinical immunology at National Jewish Health, Denver, said that his center had trouble obtaining liquid albuterol about 2 weeks ago, so they pivoted to the more expensive levalbuterol for about a week and a half, until their albuterol supply was restored.
While Dr. Rabinovitch agreed that most children don’t need a nebulizer, he said about 5%-10% of kids with severe asthma should have one on hand in case their inhaler fails to control an exacerbation.
Personal preferences may also considered, he added.
“If [a parent] says, ‘I like to use the nebulizer. The kid likes it,’ I’m fine if they just use a nebulizer.”
One possible downside of relying on a nebulizer, however, is portability, according to Kelly O’Shea, MD, assistant professor in the division of allergy and clinical immunology at the University of Michigan, Ann Arbor.
“If you’re out at the park or out at a soccer game with your kids, and they are having trouble breathing ... and they need their albuterol, you don’t have that ability if you are tied to a nebulizer,” Dr. O’Shea said in an interview. “As long as a parent feels comfortable – they feel like [their child] can get deep breaths in, I agree that you can use [an inhaler] in the infant and toddler population.”
She also agreed that a nebulizer may serve as a kind of second step if an inhaler isn’t controlling an exacerbation; however, she emphasized that a nebulizer should not be considered a replacement for professional care, and should not give a false sense of security.
“I caution parents to make sure that when they need it, they also take the next step and head over to the emergency room,” Dr. O’Shea said.
Generic drug shortages becoming more common
While the present scarcity of liquid albuterol appears relatively mild in terms of clinical impact, it brings up broader concerns about generic drug supply, and why shortages like this are becoming more common, according to Katie J. Suda, PharmD, MS, professor of medicine and pharmacy, and associate director, center for pharmaceutical policy and prescribing at the University of Pittsburgh.
“Drug shortages continue to increase in frequency, and the duration and severity of the shortages are also getting worse,” Dr. Suda said in an interview.
The reasons for these shortages can be elusive, according to 2022 report by the American Society of Health-System Pharmacists, which found that more than half of shortages came with no explanation from manufacturers.
The same report showed that only 5% of shortages were due to a “business decision,” but this factor is likely more central than publicly stated.
A recent FDA analysis on drug shortages, for instance, lists “lack of incentives to produce less profitable drugs,” as the first “root cause,” and Dr. Suda agrees.
“It’s important that we have generic medicines to decrease costs to our health systems, as well as for our patients,” Dr. Suda said. “But frequently, with those generic products, the price is driven so low that it increases the risk of a shortage.”
The drive to maintain profit margins may motivate companies to cut corners in production, Dr. Suda explained. She emphasized that this connection is speculative, because motivations are effectively unknowable, but the rationale is supported by past and present shortages.
Akorn Pharmaceuticals, for example, received a warning letter from the FDA in 2019 because of a variety of manufacturing issues, including defective bottles, questionable data, and metal shavings on aseptic filling equipment.
When a manufacturer like Akorn fails, the effects can be far-reaching, Dr. Suda said, noting their broad catalog of agents. Beyond liquid albuterol, Akorn was producing cardiac drugs, antibiotics, vitamins, local anesthetics, eye products, and others.
Drug shortages cause “a significant strain on our health care system,” Dr. Suda said, and substituting other medications increases risk of medical errors.
Fortunately, the increasing number of drug shortages is not going unnoticed, according to Dr. Suda. The FDA and multiple other organizations, including the ASHP, American Medical Association, and National Academies of Sciences, Engineering, and Medicine, are all taking steps to ensure that essential medicines are in steady supply, including moves to gather more data from manufacturers.
“I hope that a lot of the efforts that are moving forward ... will help us decrease the impact of shortages on our patients,” Dr. Suda said.
Lou Kennedy is the CEO of Nephron Pharmaceuticals, which commercially produces liquid albuterol. The other interviewees disclosed no relevant conflicts of interest.
Screen time and teenagers: Principles for parents
The Centers for Disease Control and Prevention recently released results of the most recent Youth Risk Behavior Survey, their once-a-decade survey of youth mental health and risk-taking behaviors. The headlines aren’t good: Self-reported rates of anxiety, depression, suicidal thoughts, and suicide attempts in adolescents have increased substantially from 2011 to 2021. This echoes epidemiologic data showing increasing rates of anxiety and depression over the last decade in 12- to 24-year-olds, but not in older age cohorts.
This trend started well before COVID, coinciding with the explosive growth in use of smartphones, apps, and social media platforms. Facebook launched in 2004, the iPhone in 2007, Instagram in 2010, and TikTok in 2016. A 2018 Pew Research survey of 13- to 17-year-olds found that 97% of them used at least one social media platform and 45% described themselves as online “almost constantly.” Social media does have great potential benefits for adolescents.
We all experienced how it supported relationships during COVID. It can provide supportive networks for teenagers isolated by exclusion, illness, or disability. It can support exploration of esoteric interests, expression of identity, entertainment, and relaxation. But certain children, as was true before social media, seem vulnerable to the bullying, loneliness, isolation, and disengagement that social media may exacerbate.
Several studies have shown an association between high daily screen time and adolescent anxiety and depression. These findings have not been consistently duplicated, and those that were could not establish causality. There appears to be a strong link between certain illnesses (ADHD, depression, anorexia nervosa) and excessive screen use, which can in turn worsen symptoms. But it is hard to know which came first or how they are related.
Now, a very large long-term observational study has suggested that there may be critical windows in adolescence (11-13 years in girls and 14-16 in boys and again at 19 years for both) during which time excessive screen time can put that child’s developing mental health at risk. This is nuanced and interesting progress, but you don’t have to wait another decade to offer the families in your practice some common sense guidance when they are asking how to balance their children’s needs to be independent and socially connected (and the fact that smartphones and social media are pervasive) with the risks of overuse. Equipped with these guiding principles, parents can set individualized, flexible ground rules, and adjust them as their children grow into young adults.
First: Know your child
Parents are, of course, the experts on their own child – their talents, interests, challenges, vulnerabilities, and developmental progress. Children with poor impulse control (including those with ADHD) are going to have greater difficulty turning away from highly addictive activities on their devices. Children who are anxious and shy may be prone to avoiding the stress of real-life situations, preferring virtual ones. Children with a history of depression may be vulnerable to relapse if their sleep and exercise routines are disrupted by excessive use. And children with eating disorders are especially vulnerable to the superficial social comparisons and “likes” that Instagram offers. Children with these vulnerabilities will benefit if their parents are aware of and can talk about these vulnerabilities, ideally with their child. They should be prepared to work with their teens to develop strategies that can help them learn how to manage their social media usage. These might include stopping screen use after a certain hour, leaving devices outside of bedrooms at night, and setting up apps that monitor and alert them about excessive use. They might use resources such as the AAP’s Family Media Plan (Media and Children [aap.org]), but simply taking the time to have regular, open, honest conversations about what is known and unknown about the potential risks of social media use is very protective.
Second: Use adolescent development as your guide
For those children who do not have a known vulnerability to overuse, consider the following areas that are essential to healthy development in adolescence as guideposts to help parents in setting reasonable ground rules: building independence, cultivating healthy social relationships, learning about their identity, managing their strong emotions, and developing the skills of self-care. If screen time supports these developmental areas, then it’s probably healthy. If it interferes with them, then not. And remember, parents should routinely discuss these principles with their children as well.
Independence
Key questions. Does their use of a device enable them to function more independently – that is, to arrange for rides, manage their schedules, homework, shifts, and so forth – on their own? Could it be done with a “dumb” device (text/call only)?
Social relationships
One-way viewing (Instagram, Facebook) with superficial acquaintances may promote isolation, anxiety, and depression, does not facilitate deepened relationships, and may be using up time that they could be investing in genuine social connections. But if they are using their devices to stay connected to good friends who live far away or just have different schedules, they can promote genuine, satisfying, bilateral social connections.
Key questions. Are they engaged in two-way communication with their devices? Are they staying connected to friends with whom they have a genuine, substantial relationship?
Investigating and experimenting with interests (identity)
Teenagers are supposed to be learning in deep and nuanced ways about their own interests and abilities during these years. This requires a lot of time invested in exploration and experimentation and a considerable amount of failure. Any activity that consumes a lot of their time without deepening meaningful knowledge of their interests and abilities (that is, activity that is only an escape or distraction) will interfere with their discovering their authentic identity.
Key questions. Is their use of devices facilitating this genuine exploration (setting up internships, practicing programming, or exploring interests that must be virtual)? Or is their device use just consuming precious time they could be using to genuinely explore potential interests?
Managing anxiety or distress
Exploring their identity and building social connections will involve a lot of stress, failure, disappointment, and even heartbreak. Learning to manage these uncomfortable feelings is an important part of adolescence. Distraction with a diverting entertainment can be one of several strategies for managing stress and distress. But if it becomes the only strategy, it can keep teens from getting “back in the game” and experiencing the fun, success, meaning, and joy that are also a big part of this exploration.
Key questions. Do they turn to their devices first when sad or stressed? Are they also able to use other strategies, such as talking with friends/family, exercising, or engaging in a meaningful pursuit to help them manage stress? Do they feel better after a little time spent on their device, or as if they will only feel good if they can stay on the device?
Self-care
Getting adequate, restful sleep (8-10 hours/night), finding regular time for exercise, cultivating healthy eating habits, and discovering what healthy strategies help them to unwind or relax is critical to a teenager’s healthiest development, and to healthy adult life. Some screens may help with motivating and tracking exercise, but screens in the bedroom interfere with going to bed, and with falling and staying asleep. Most teenagers are very busy and managing a lot of (normal) stress; the senseless fun or relaxation that are part of video games or surfing the Web are quick, practical, and effective ways to unwind. Don’t discourage your teenager from enjoying them. Instead, focus on also helping them to find other healthy ways to relax: hot baths, exercise, time with pets, crafts, reading, and listening to music are just a few examples. As they are building their identity, they should also be discovering how they best slow down and calm down.
Key questions. How many hours of sleep do they usually get on a school night? Is their phone (or other screen) in their bedroom during sleep? How do they relax? Do they have several strategies that do not require screens? Do they exercise regularly (3-5 times weekly)? Do they complain that they do not have enough time for exercise?
Third: Be mindful of what you model
Many of these principles can apply to our own use of smartphones, computers, and so on. Remind parents that their teenager will ultimately consider and follow their example much more than their commands. They should be prepared to talk about how they are thinking about the risks and benefits of social media use, how they are developing rules and expectations, and why they decided on them. These conversations model thoughtful and flexible decision-making.
It is critical that parents acknowledge that there are wonderful benefits to technology, including senseless fun. Then, it is easier to discuss how escaping into screen use can be hard to resist, and why it is important to practice resisting some temptations. Parents should find ways to follow the same rules they set for their teenager, or making them “family rules.” It’s important for our teenagers to learn about how to set these limits, as eventually they will be setting their own!
Dr. Swick is physician in chief at Ohana Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
The Centers for Disease Control and Prevention recently released results of the most recent Youth Risk Behavior Survey, their once-a-decade survey of youth mental health and risk-taking behaviors. The headlines aren’t good: Self-reported rates of anxiety, depression, suicidal thoughts, and suicide attempts in adolescents have increased substantially from 2011 to 2021. This echoes epidemiologic data showing increasing rates of anxiety and depression over the last decade in 12- to 24-year-olds, but not in older age cohorts.
This trend started well before COVID, coinciding with the explosive growth in use of smartphones, apps, and social media platforms. Facebook launched in 2004, the iPhone in 2007, Instagram in 2010, and TikTok in 2016. A 2018 Pew Research survey of 13- to 17-year-olds found that 97% of them used at least one social media platform and 45% described themselves as online “almost constantly.” Social media does have great potential benefits for adolescents.
We all experienced how it supported relationships during COVID. It can provide supportive networks for teenagers isolated by exclusion, illness, or disability. It can support exploration of esoteric interests, expression of identity, entertainment, and relaxation. But certain children, as was true before social media, seem vulnerable to the bullying, loneliness, isolation, and disengagement that social media may exacerbate.
Several studies have shown an association between high daily screen time and adolescent anxiety and depression. These findings have not been consistently duplicated, and those that were could not establish causality. There appears to be a strong link between certain illnesses (ADHD, depression, anorexia nervosa) and excessive screen use, which can in turn worsen symptoms. But it is hard to know which came first or how they are related.
Now, a very large long-term observational study has suggested that there may be critical windows in adolescence (11-13 years in girls and 14-16 in boys and again at 19 years for both) during which time excessive screen time can put that child’s developing mental health at risk. This is nuanced and interesting progress, but you don’t have to wait another decade to offer the families in your practice some common sense guidance when they are asking how to balance their children’s needs to be independent and socially connected (and the fact that smartphones and social media are pervasive) with the risks of overuse. Equipped with these guiding principles, parents can set individualized, flexible ground rules, and adjust them as their children grow into young adults.
First: Know your child
Parents are, of course, the experts on their own child – their talents, interests, challenges, vulnerabilities, and developmental progress. Children with poor impulse control (including those with ADHD) are going to have greater difficulty turning away from highly addictive activities on their devices. Children who are anxious and shy may be prone to avoiding the stress of real-life situations, preferring virtual ones. Children with a history of depression may be vulnerable to relapse if their sleep and exercise routines are disrupted by excessive use. And children with eating disorders are especially vulnerable to the superficial social comparisons and “likes” that Instagram offers. Children with these vulnerabilities will benefit if their parents are aware of and can talk about these vulnerabilities, ideally with their child. They should be prepared to work with their teens to develop strategies that can help them learn how to manage their social media usage. These might include stopping screen use after a certain hour, leaving devices outside of bedrooms at night, and setting up apps that monitor and alert them about excessive use. They might use resources such as the AAP’s Family Media Plan (Media and Children [aap.org]), but simply taking the time to have regular, open, honest conversations about what is known and unknown about the potential risks of social media use is very protective.
Second: Use adolescent development as your guide
For those children who do not have a known vulnerability to overuse, consider the following areas that are essential to healthy development in adolescence as guideposts to help parents in setting reasonable ground rules: building independence, cultivating healthy social relationships, learning about their identity, managing their strong emotions, and developing the skills of self-care. If screen time supports these developmental areas, then it’s probably healthy. If it interferes with them, then not. And remember, parents should routinely discuss these principles with their children as well.
Independence
Key questions. Does their use of a device enable them to function more independently – that is, to arrange for rides, manage their schedules, homework, shifts, and so forth – on their own? Could it be done with a “dumb” device (text/call only)?
Social relationships
One-way viewing (Instagram, Facebook) with superficial acquaintances may promote isolation, anxiety, and depression, does not facilitate deepened relationships, and may be using up time that they could be investing in genuine social connections. But if they are using their devices to stay connected to good friends who live far away or just have different schedules, they can promote genuine, satisfying, bilateral social connections.
Key questions. Are they engaged in two-way communication with their devices? Are they staying connected to friends with whom they have a genuine, substantial relationship?
Investigating and experimenting with interests (identity)
Teenagers are supposed to be learning in deep and nuanced ways about their own interests and abilities during these years. This requires a lot of time invested in exploration and experimentation and a considerable amount of failure. Any activity that consumes a lot of their time without deepening meaningful knowledge of their interests and abilities (that is, activity that is only an escape or distraction) will interfere with their discovering their authentic identity.
Key questions. Is their use of devices facilitating this genuine exploration (setting up internships, practicing programming, or exploring interests that must be virtual)? Or is their device use just consuming precious time they could be using to genuinely explore potential interests?
Managing anxiety or distress
Exploring their identity and building social connections will involve a lot of stress, failure, disappointment, and even heartbreak. Learning to manage these uncomfortable feelings is an important part of adolescence. Distraction with a diverting entertainment can be one of several strategies for managing stress and distress. But if it becomes the only strategy, it can keep teens from getting “back in the game” and experiencing the fun, success, meaning, and joy that are also a big part of this exploration.
Key questions. Do they turn to their devices first when sad or stressed? Are they also able to use other strategies, such as talking with friends/family, exercising, or engaging in a meaningful pursuit to help them manage stress? Do they feel better after a little time spent on their device, or as if they will only feel good if they can stay on the device?
Self-care
Getting adequate, restful sleep (8-10 hours/night), finding regular time for exercise, cultivating healthy eating habits, and discovering what healthy strategies help them to unwind or relax is critical to a teenager’s healthiest development, and to healthy adult life. Some screens may help with motivating and tracking exercise, but screens in the bedroom interfere with going to bed, and with falling and staying asleep. Most teenagers are very busy and managing a lot of (normal) stress; the senseless fun or relaxation that are part of video games or surfing the Web are quick, practical, and effective ways to unwind. Don’t discourage your teenager from enjoying them. Instead, focus on also helping them to find other healthy ways to relax: hot baths, exercise, time with pets, crafts, reading, and listening to music are just a few examples. As they are building their identity, they should also be discovering how they best slow down and calm down.
Key questions. How many hours of sleep do they usually get on a school night? Is their phone (or other screen) in their bedroom during sleep? How do they relax? Do they have several strategies that do not require screens? Do they exercise regularly (3-5 times weekly)? Do they complain that they do not have enough time for exercise?
Third: Be mindful of what you model
Many of these principles can apply to our own use of smartphones, computers, and so on. Remind parents that their teenager will ultimately consider and follow their example much more than their commands. They should be prepared to talk about how they are thinking about the risks and benefits of social media use, how they are developing rules and expectations, and why they decided on them. These conversations model thoughtful and flexible decision-making.
It is critical that parents acknowledge that there are wonderful benefits to technology, including senseless fun. Then, it is easier to discuss how escaping into screen use can be hard to resist, and why it is important to practice resisting some temptations. Parents should find ways to follow the same rules they set for their teenager, or making them “family rules.” It’s important for our teenagers to learn about how to set these limits, as eventually they will be setting their own!
Dr. Swick is physician in chief at Ohana Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
The Centers for Disease Control and Prevention recently released results of the most recent Youth Risk Behavior Survey, their once-a-decade survey of youth mental health and risk-taking behaviors. The headlines aren’t good: Self-reported rates of anxiety, depression, suicidal thoughts, and suicide attempts in adolescents have increased substantially from 2011 to 2021. This echoes epidemiologic data showing increasing rates of anxiety and depression over the last decade in 12- to 24-year-olds, but not in older age cohorts.
This trend started well before COVID, coinciding with the explosive growth in use of smartphones, apps, and social media platforms. Facebook launched in 2004, the iPhone in 2007, Instagram in 2010, and TikTok in 2016. A 2018 Pew Research survey of 13- to 17-year-olds found that 97% of them used at least one social media platform and 45% described themselves as online “almost constantly.” Social media does have great potential benefits for adolescents.
We all experienced how it supported relationships during COVID. It can provide supportive networks for teenagers isolated by exclusion, illness, or disability. It can support exploration of esoteric interests, expression of identity, entertainment, and relaxation. But certain children, as was true before social media, seem vulnerable to the bullying, loneliness, isolation, and disengagement that social media may exacerbate.
Several studies have shown an association between high daily screen time and adolescent anxiety and depression. These findings have not been consistently duplicated, and those that were could not establish causality. There appears to be a strong link between certain illnesses (ADHD, depression, anorexia nervosa) and excessive screen use, which can in turn worsen symptoms. But it is hard to know which came first or how they are related.
Now, a very large long-term observational study has suggested that there may be critical windows in adolescence (11-13 years in girls and 14-16 in boys and again at 19 years for both) during which time excessive screen time can put that child’s developing mental health at risk. This is nuanced and interesting progress, but you don’t have to wait another decade to offer the families in your practice some common sense guidance when they are asking how to balance their children’s needs to be independent and socially connected (and the fact that smartphones and social media are pervasive) with the risks of overuse. Equipped with these guiding principles, parents can set individualized, flexible ground rules, and adjust them as their children grow into young adults.
First: Know your child
Parents are, of course, the experts on their own child – their talents, interests, challenges, vulnerabilities, and developmental progress. Children with poor impulse control (including those with ADHD) are going to have greater difficulty turning away from highly addictive activities on their devices. Children who are anxious and shy may be prone to avoiding the stress of real-life situations, preferring virtual ones. Children with a history of depression may be vulnerable to relapse if their sleep and exercise routines are disrupted by excessive use. And children with eating disorders are especially vulnerable to the superficial social comparisons and “likes” that Instagram offers. Children with these vulnerabilities will benefit if their parents are aware of and can talk about these vulnerabilities, ideally with their child. They should be prepared to work with their teens to develop strategies that can help them learn how to manage their social media usage. These might include stopping screen use after a certain hour, leaving devices outside of bedrooms at night, and setting up apps that monitor and alert them about excessive use. They might use resources such as the AAP’s Family Media Plan (Media and Children [aap.org]), but simply taking the time to have regular, open, honest conversations about what is known and unknown about the potential risks of social media use is very protective.
Second: Use adolescent development as your guide
For those children who do not have a known vulnerability to overuse, consider the following areas that are essential to healthy development in adolescence as guideposts to help parents in setting reasonable ground rules: building independence, cultivating healthy social relationships, learning about their identity, managing their strong emotions, and developing the skills of self-care. If screen time supports these developmental areas, then it’s probably healthy. If it interferes with them, then not. And remember, parents should routinely discuss these principles with their children as well.
Independence
Key questions. Does their use of a device enable them to function more independently – that is, to arrange for rides, manage their schedules, homework, shifts, and so forth – on their own? Could it be done with a “dumb” device (text/call only)?
Social relationships
One-way viewing (Instagram, Facebook) with superficial acquaintances may promote isolation, anxiety, and depression, does not facilitate deepened relationships, and may be using up time that they could be investing in genuine social connections. But if they are using their devices to stay connected to good friends who live far away or just have different schedules, they can promote genuine, satisfying, bilateral social connections.
Key questions. Are they engaged in two-way communication with their devices? Are they staying connected to friends with whom they have a genuine, substantial relationship?
Investigating and experimenting with interests (identity)
Teenagers are supposed to be learning in deep and nuanced ways about their own interests and abilities during these years. This requires a lot of time invested in exploration and experimentation and a considerable amount of failure. Any activity that consumes a lot of their time without deepening meaningful knowledge of their interests and abilities (that is, activity that is only an escape or distraction) will interfere with their discovering their authentic identity.
Key questions. Is their use of devices facilitating this genuine exploration (setting up internships, practicing programming, or exploring interests that must be virtual)? Or is their device use just consuming precious time they could be using to genuinely explore potential interests?
Managing anxiety or distress
Exploring their identity and building social connections will involve a lot of stress, failure, disappointment, and even heartbreak. Learning to manage these uncomfortable feelings is an important part of adolescence. Distraction with a diverting entertainment can be one of several strategies for managing stress and distress. But if it becomes the only strategy, it can keep teens from getting “back in the game” and experiencing the fun, success, meaning, and joy that are also a big part of this exploration.
Key questions. Do they turn to their devices first when sad or stressed? Are they also able to use other strategies, such as talking with friends/family, exercising, or engaging in a meaningful pursuit to help them manage stress? Do they feel better after a little time spent on their device, or as if they will only feel good if they can stay on the device?
Self-care
Getting adequate, restful sleep (8-10 hours/night), finding regular time for exercise, cultivating healthy eating habits, and discovering what healthy strategies help them to unwind or relax is critical to a teenager’s healthiest development, and to healthy adult life. Some screens may help with motivating and tracking exercise, but screens in the bedroom interfere with going to bed, and with falling and staying asleep. Most teenagers are very busy and managing a lot of (normal) stress; the senseless fun or relaxation that are part of video games or surfing the Web are quick, practical, and effective ways to unwind. Don’t discourage your teenager from enjoying them. Instead, focus on also helping them to find other healthy ways to relax: hot baths, exercise, time with pets, crafts, reading, and listening to music are just a few examples. As they are building their identity, they should also be discovering how they best slow down and calm down.
Key questions. How many hours of sleep do they usually get on a school night? Is their phone (or other screen) in their bedroom during sleep? How do they relax? Do they have several strategies that do not require screens? Do they exercise regularly (3-5 times weekly)? Do they complain that they do not have enough time for exercise?
Third: Be mindful of what you model
Many of these principles can apply to our own use of smartphones, computers, and so on. Remind parents that their teenager will ultimately consider and follow their example much more than their commands. They should be prepared to talk about how they are thinking about the risks and benefits of social media use, how they are developing rules and expectations, and why they decided on them. These conversations model thoughtful and flexible decision-making.
It is critical that parents acknowledge that there are wonderful benefits to technology, including senseless fun. Then, it is easier to discuss how escaping into screen use can be hard to resist, and why it is important to practice resisting some temptations. Parents should find ways to follow the same rules they set for their teenager, or making them “family rules.” It’s important for our teenagers to learn about how to set these limits, as eventually they will be setting their own!
Dr. Swick is physician in chief at Ohana Center for Child and Adolescent Behavioral Health, Community Hospital of the Monterey (Calif.) Peninsula. Dr. Jellinek is professor emeritus of psychiatry and pediatrics, Harvard Medical School, Boston. Email them at [email protected].
Children with ASD less likely to get vision screening
Children with autism spectrum disorder (ASD) are significantly less likely to have vision screening at well visits for 3- to 5-year-olds than are typically developing children, researchers have found.
The report, by Kimberly Hoover, MD, of Thomas Jefferson University in Philadelphia, and colleagues, was published online in Pediatrics.
While 59.9% of children without ASD got vision screening in these visits, only 36.5% of children with ASD got the screening. Both screening rates miss the mark set by American Academy of Pediatrics guidelines.
The AAP recommends “annual instrument-based vision screening, if available, at well visits for children starting at age 12 months to 3 years, and direct visual acuity testing beginning at 4 years of age. However, in children with developmental delays, the AAP recommends instrument-based screening, such as photoscreening, as a useful alternative at any age.”
Racial, age disparities as well
Racial disparities were evident in the data as well. Of the children who had ASD, Black children had the lowest rates of screening (27.6%), while the rate for White children was 39.7%. The rate for other/multiracial children with ASD was 39.8%.
The lowest rates of screening occurred in the youngest children, at the 3-year visit.
The researchers analyzed data from 63,829 well-child visits between January 2016 and December 2019, collected from the large primary care database PEDSnet.
Photoscreening vs. acuity screening
The authors pointed out that children with ASD are less likely to complete a vision test, which can be problematic in a busy primary care office.
“Children with ASD were significantly less likely to have at least one completed vision screening (43.2%) compared with children without ASD (72.1%; P <. 01),” the authors wrote, “with only 6.9% of children with ASD having had two or more vision screenings compared with 22.3% of children without ASD.”
The researchers saw higher vision test completion rates with photoscreening, using a sophisticated camera, compared with acuity screening, which uses a wall chart and requires responses.
Less patient participation is required for photoscreening and it can be done in less than 2 minutes.
If ability to complete the vision tests is a concern, the authors wrote, photoscreening may be a better solution.
Photoscreening takes 90 seconds
“Photoscreening has high sensitivity in detecting ocular conditions in children with ASD and has an average screening time of 90 seconds, and [it has] been validated in both children with ASD and developmental delays,” the authors wrote.
Andrew Adesman, MD, chief of developmental and behavioral pediatrics at Cohen Children’s Medical Center in New Hyde Park, N.Y., said the authors of this study quantify the gap between need and reality for vision tests for those with ASD.
“Other studies have shown that children on the autism spectrum have more than three times greater risk of having eye disease or vision problems,” he said in an interview. “You’ve got a high-risk population in need of assessment and the likelihood of them getting an assessment is much reduced.”
He said in addition to attention problems in taking the test, vision screening may get lost in the plethora of concerns parents want to talk about in well-child visits.
“If you’re the parent of a child with developmental delays, language delays, poor social engagement, there are a multitude of things the visit could be focused on and it may be that vision screening possibly gets compromised or not done,” Dr. Adesman said.
That, he said, may be a focus area for improving the screening numbers.
Neither parents nor providers should forget that vision screening is important, despite the myriad other issues to address, he said. “They don’t have to take a long time.”
When it comes to vision problems and children, “the earlier they’re identified the better,” Dr. Adesman says, particularly to identify the need for eye muscle surgery or corrective lenses, the two major interventions for strabismus or refractive error.
“If those problems are significant and go untreated, there’s a risk of loss of vision in the affected eye,” he said.
Reimbursement concerns for photoscreening
This study strongly supports the use of routine photoscreening to help eliminate the vision screening gap in children with ASD, the authors wrote.
They noted, however, that would require insurance reimbursement for primary care practices to effectively use that screening.
The researchers advised, “Providers treating patients with race, ethnicity, region, or age categories that reduce the adjusted odds of photoscreening can take steps in their practices to address these disparities, particularly in children with ASD.”
The study authors and Dr. Adesman reported no relevant financial relationships.
Children with autism spectrum disorder (ASD) are significantly less likely to have vision screening at well visits for 3- to 5-year-olds than are typically developing children, researchers have found.
The report, by Kimberly Hoover, MD, of Thomas Jefferson University in Philadelphia, and colleagues, was published online in Pediatrics.
While 59.9% of children without ASD got vision screening in these visits, only 36.5% of children with ASD got the screening. Both screening rates miss the mark set by American Academy of Pediatrics guidelines.
The AAP recommends “annual instrument-based vision screening, if available, at well visits for children starting at age 12 months to 3 years, and direct visual acuity testing beginning at 4 years of age. However, in children with developmental delays, the AAP recommends instrument-based screening, such as photoscreening, as a useful alternative at any age.”
Racial, age disparities as well
Racial disparities were evident in the data as well. Of the children who had ASD, Black children had the lowest rates of screening (27.6%), while the rate for White children was 39.7%. The rate for other/multiracial children with ASD was 39.8%.
The lowest rates of screening occurred in the youngest children, at the 3-year visit.
The researchers analyzed data from 63,829 well-child visits between January 2016 and December 2019, collected from the large primary care database PEDSnet.
Photoscreening vs. acuity screening
The authors pointed out that children with ASD are less likely to complete a vision test, which can be problematic in a busy primary care office.
“Children with ASD were significantly less likely to have at least one completed vision screening (43.2%) compared with children without ASD (72.1%; P <. 01),” the authors wrote, “with only 6.9% of children with ASD having had two or more vision screenings compared with 22.3% of children without ASD.”
The researchers saw higher vision test completion rates with photoscreening, using a sophisticated camera, compared with acuity screening, which uses a wall chart and requires responses.
Less patient participation is required for photoscreening and it can be done in less than 2 minutes.
If ability to complete the vision tests is a concern, the authors wrote, photoscreening may be a better solution.
Photoscreening takes 90 seconds
“Photoscreening has high sensitivity in detecting ocular conditions in children with ASD and has an average screening time of 90 seconds, and [it has] been validated in both children with ASD and developmental delays,” the authors wrote.
Andrew Adesman, MD, chief of developmental and behavioral pediatrics at Cohen Children’s Medical Center in New Hyde Park, N.Y., said the authors of this study quantify the gap between need and reality for vision tests for those with ASD.
“Other studies have shown that children on the autism spectrum have more than three times greater risk of having eye disease or vision problems,” he said in an interview. “You’ve got a high-risk population in need of assessment and the likelihood of them getting an assessment is much reduced.”
He said in addition to attention problems in taking the test, vision screening may get lost in the plethora of concerns parents want to talk about in well-child visits.
“If you’re the parent of a child with developmental delays, language delays, poor social engagement, there are a multitude of things the visit could be focused on and it may be that vision screening possibly gets compromised or not done,” Dr. Adesman said.
That, he said, may be a focus area for improving the screening numbers.
Neither parents nor providers should forget that vision screening is important, despite the myriad other issues to address, he said. “They don’t have to take a long time.”
When it comes to vision problems and children, “the earlier they’re identified the better,” Dr. Adesman says, particularly to identify the need for eye muscle surgery or corrective lenses, the two major interventions for strabismus or refractive error.
“If those problems are significant and go untreated, there’s a risk of loss of vision in the affected eye,” he said.
Reimbursement concerns for photoscreening
This study strongly supports the use of routine photoscreening to help eliminate the vision screening gap in children with ASD, the authors wrote.
They noted, however, that would require insurance reimbursement for primary care practices to effectively use that screening.
The researchers advised, “Providers treating patients with race, ethnicity, region, or age categories that reduce the adjusted odds of photoscreening can take steps in their practices to address these disparities, particularly in children with ASD.”
The study authors and Dr. Adesman reported no relevant financial relationships.
Children with autism spectrum disorder (ASD) are significantly less likely to have vision screening at well visits for 3- to 5-year-olds than are typically developing children, researchers have found.
The report, by Kimberly Hoover, MD, of Thomas Jefferson University in Philadelphia, and colleagues, was published online in Pediatrics.
While 59.9% of children without ASD got vision screening in these visits, only 36.5% of children with ASD got the screening. Both screening rates miss the mark set by American Academy of Pediatrics guidelines.
The AAP recommends “annual instrument-based vision screening, if available, at well visits for children starting at age 12 months to 3 years, and direct visual acuity testing beginning at 4 years of age. However, in children with developmental delays, the AAP recommends instrument-based screening, such as photoscreening, as a useful alternative at any age.”
Racial, age disparities as well
Racial disparities were evident in the data as well. Of the children who had ASD, Black children had the lowest rates of screening (27.6%), while the rate for White children was 39.7%. The rate for other/multiracial children with ASD was 39.8%.
The lowest rates of screening occurred in the youngest children, at the 3-year visit.
The researchers analyzed data from 63,829 well-child visits between January 2016 and December 2019, collected from the large primary care database PEDSnet.
Photoscreening vs. acuity screening
The authors pointed out that children with ASD are less likely to complete a vision test, which can be problematic in a busy primary care office.
“Children with ASD were significantly less likely to have at least one completed vision screening (43.2%) compared with children without ASD (72.1%; P <. 01),” the authors wrote, “with only 6.9% of children with ASD having had two or more vision screenings compared with 22.3% of children without ASD.”
The researchers saw higher vision test completion rates with photoscreening, using a sophisticated camera, compared with acuity screening, which uses a wall chart and requires responses.
Less patient participation is required for photoscreening and it can be done in less than 2 minutes.
If ability to complete the vision tests is a concern, the authors wrote, photoscreening may be a better solution.
Photoscreening takes 90 seconds
“Photoscreening has high sensitivity in detecting ocular conditions in children with ASD and has an average screening time of 90 seconds, and [it has] been validated in both children with ASD and developmental delays,” the authors wrote.
Andrew Adesman, MD, chief of developmental and behavioral pediatrics at Cohen Children’s Medical Center in New Hyde Park, N.Y., said the authors of this study quantify the gap between need and reality for vision tests for those with ASD.
“Other studies have shown that children on the autism spectrum have more than three times greater risk of having eye disease or vision problems,” he said in an interview. “You’ve got a high-risk population in need of assessment and the likelihood of them getting an assessment is much reduced.”
He said in addition to attention problems in taking the test, vision screening may get lost in the plethora of concerns parents want to talk about in well-child visits.
“If you’re the parent of a child with developmental delays, language delays, poor social engagement, there are a multitude of things the visit could be focused on and it may be that vision screening possibly gets compromised or not done,” Dr. Adesman said.
That, he said, may be a focus area for improving the screening numbers.
Neither parents nor providers should forget that vision screening is important, despite the myriad other issues to address, he said. “They don’t have to take a long time.”
When it comes to vision problems and children, “the earlier they’re identified the better,” Dr. Adesman says, particularly to identify the need for eye muscle surgery or corrective lenses, the two major interventions for strabismus or refractive error.
“If those problems are significant and go untreated, there’s a risk of loss of vision in the affected eye,” he said.
Reimbursement concerns for photoscreening
This study strongly supports the use of routine photoscreening to help eliminate the vision screening gap in children with ASD, the authors wrote.
They noted, however, that would require insurance reimbursement for primary care practices to effectively use that screening.
The researchers advised, “Providers treating patients with race, ethnicity, region, or age categories that reduce the adjusted odds of photoscreening can take steps in their practices to address these disparities, particularly in children with ASD.”
The study authors and Dr. Adesman reported no relevant financial relationships.
FROM PEDIATRICS
COVID-19 vaccinations lag in youngest children
Case: A 3-year-old girl presented to the emergency department after a brief seizure at home. She looked well on physical exam except for a fever of 103° F and thick rhinorrhea.
The intern on duty methodically worked through the standard list of questions. “Immunizations up to date?” she asked.
“Absolutely,” the child’s mom responded. “She’s had everything that’s recommended.”
“Including COVID-19 vaccine?” the intern prompted.
“No.” The mom responded with a shake of her head. “We don’t do that vaccine.”
That mom is not alone.
COVID-19 vaccines for children as young as 6 months were given emergency-use authorization by the Food and Drug Administration in June 2022 and in February 2023, the Advisory Committee on Immunization Practices included COVID-19 vaccine on the routine childhood immunization schedule.
COVID-19 vaccines are safe in young children, and they prevent the most severe outcomes associated with infection, including hospitalization. Newly released data confirm that the COVID-19 vaccines produced by Moderna and Pfizer also provide protection against symptomatic infection for at least 4 months after completion of the monovalent primary series.
In a Morbidity and Mortality Weekly Report released on Feb. 17, 2023, the Centers for Disease Control and Prevention reported the results of a test-negative design case-control study that enrolled symptomatic children tested for SARS-CoV-2 infection through Feb. 5, 2023, as part of the Increasing Community Access to Testing (ICATT) program.1 ICATT provides SARS-CoV-2 testing to persons aged at least 3 years at pharmacy and community-based testing sites nationwide.
Two doses of monovalent Moderna vaccine (complete primary series) was 60% effective against symptomatic infection (95% confidence interval, 49%-68%) 2 weeks to 2 months after receipt of the second dose. Vaccine effectiveness dropped to 36% (95% CI, 15%-52%) 3-4 months after the second dose. Three doses of monovalent Pfizer-BioNTech vaccine (complete primary series) was 31% effective (95% CI, 7%-49%) at preventing symptomatic infection 2 weeks to 4 months after receipt of the third dose. A bivalent vaccine dose for eligible children is expected to provide more protection against currently circulating SARS-CoV-2 variants.
Despite evidence of vaccine efficacy, very few parents are opting to protect their young children with the COVID-19 vaccine. The CDC reports that, as of March 1, 2023, only 8% of children under 2 years and 10.5% of children aged 2-4 years have initiated a COVID vaccine series. The American Academy of Pediatrics has emphasized that 15.0 million children between the ages of 6 months and 4 years have not yet received their first COVID-19 vaccine dose.
While the reasons underlying low COVID-19 vaccination rates in young children are complex, themes emerge. Socioeconomic disparities contributing to low vaccination rates in young children were highlighted in another recent MMWR article.2 Through Dec. 1, 2022, vaccination coverage was lower in rural counties (3.4%) than in urban counties (10.5%). Rates were lower in Black and Hispanic children than in White and Asian children.
According to the CDC, high rates of poverty in Black and Hispanic communities may affect vaccination coverage by affecting caregivers’ access to vaccination sites or ability to leave work to take their child to be vaccinated. Pediatric care providers have repeatedly been identified by parents as a source of trusted vaccine information and a strong provider recommendation is associated with vaccination, but not all families are receiving vaccine advice. In a 2022 Kaiser Family Foundation survey, parents of young children with annual household incomes above $90,000 were more likely to talk to their pediatrician about a COVID-19 vaccine than families with lower incomes.3Vaccine hesitancy, fueled by general confusion and skepticism, is another factor contributing to low vaccination rates. Admittedly, the recommendations are complex and on March 14, 2023, the FDA again revised the emergency-use authorization for young children. Some caregivers continue to express concerns about vaccine side effects as well as the belief that the vaccine won’t prevent their child from getting sick.
Kendall Purcell, MD, a pediatrician with Norton Children’s Medical Group in Louisville, Ky., recommends COVID-19 vaccination for her patients because it reduces the risk of severe disease. That factored into her own decision to vaccinate her 4-year-old son and 1-year-old daughter, but she hasn’t been able to convince the parents of all her patients. “Some feel that COVID-19 is not as severe for children, so the risks don’t outweigh the benefits when it comes to vaccinating their children.” Back to our case: In the ED the intern reviewed the laboratory testing she had ordered. She then sat down with the mother of the 3-year-old girl to discuss the diagnosis: febrile seizure associated with COVID-19 infection. Febrile seizures are a well-recognized but uncommon complication of COVID-19 in children. In a retrospective cohort study using electronic health record data, febrile seizures occurred in 0.5% of 8,854 children aged 0-5 years with COVID-19 infection.4 About 9% of these children required critical care services. In another cohort of hospitalized children, neurologic complications occurred in 7% of children hospitalized with COVID-19.5 Febrile and nonfebrile seizures were most commonly observed.
“I really thought COVID-19 was no big deal in young kids,” the mom said. “Parents need the facts.”
The facts are these: Through Dec. 2, 2022, more than 3 million cases of COVID-19 have been reported in children aged younger than 5 years. While COVID is generally less severe in young children than older adults, it is difficult to predict which children will become seriously ill. When children are hospitalized, one in four requires intensive care. COVID-19 is now a vaccine-preventable disease, but too many children remain unprotected.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta, and Gilead. Email her at [email protected]. Ms. Ezell is a recent graduate from Indiana University Southeast with a Bachelor of Arts in English. They have no conflicts of interest.
References
1. Fleming-Dutra KE et al. Morb Mortal Wkly Rep. 2023;72:177-182.
2. Murthy BP et al. Morb Mortal Wkly Rep. 2023;72:183-9.
3. Lopes L et al. KFF COVID-19 vaccine monitor: July 2022. San Francisco: Kaiser Family Foundation, 2022.
4. Cadet K et al. J Child Neurol. 2022 Apr;37(5):410-5.
5. Antoon JW et al. Pediatrics. 2022 Nov 1;150(5):e2022058167.
Case: A 3-year-old girl presented to the emergency department after a brief seizure at home. She looked well on physical exam except for a fever of 103° F and thick rhinorrhea.
The intern on duty methodically worked through the standard list of questions. “Immunizations up to date?” she asked.
“Absolutely,” the child’s mom responded. “She’s had everything that’s recommended.”
“Including COVID-19 vaccine?” the intern prompted.
“No.” The mom responded with a shake of her head. “We don’t do that vaccine.”
That mom is not alone.
COVID-19 vaccines for children as young as 6 months were given emergency-use authorization by the Food and Drug Administration in June 2022 and in February 2023, the Advisory Committee on Immunization Practices included COVID-19 vaccine on the routine childhood immunization schedule.
COVID-19 vaccines are safe in young children, and they prevent the most severe outcomes associated with infection, including hospitalization. Newly released data confirm that the COVID-19 vaccines produced by Moderna and Pfizer also provide protection against symptomatic infection for at least 4 months after completion of the monovalent primary series.
In a Morbidity and Mortality Weekly Report released on Feb. 17, 2023, the Centers for Disease Control and Prevention reported the results of a test-negative design case-control study that enrolled symptomatic children tested for SARS-CoV-2 infection through Feb. 5, 2023, as part of the Increasing Community Access to Testing (ICATT) program.1 ICATT provides SARS-CoV-2 testing to persons aged at least 3 years at pharmacy and community-based testing sites nationwide.
Two doses of monovalent Moderna vaccine (complete primary series) was 60% effective against symptomatic infection (95% confidence interval, 49%-68%) 2 weeks to 2 months after receipt of the second dose. Vaccine effectiveness dropped to 36% (95% CI, 15%-52%) 3-4 months after the second dose. Three doses of monovalent Pfizer-BioNTech vaccine (complete primary series) was 31% effective (95% CI, 7%-49%) at preventing symptomatic infection 2 weeks to 4 months after receipt of the third dose. A bivalent vaccine dose for eligible children is expected to provide more protection against currently circulating SARS-CoV-2 variants.
Despite evidence of vaccine efficacy, very few parents are opting to protect their young children with the COVID-19 vaccine. The CDC reports that, as of March 1, 2023, only 8% of children under 2 years and 10.5% of children aged 2-4 years have initiated a COVID vaccine series. The American Academy of Pediatrics has emphasized that 15.0 million children between the ages of 6 months and 4 years have not yet received their first COVID-19 vaccine dose.
While the reasons underlying low COVID-19 vaccination rates in young children are complex, themes emerge. Socioeconomic disparities contributing to low vaccination rates in young children were highlighted in another recent MMWR article.2 Through Dec. 1, 2022, vaccination coverage was lower in rural counties (3.4%) than in urban counties (10.5%). Rates were lower in Black and Hispanic children than in White and Asian children.
According to the CDC, high rates of poverty in Black and Hispanic communities may affect vaccination coverage by affecting caregivers’ access to vaccination sites or ability to leave work to take their child to be vaccinated. Pediatric care providers have repeatedly been identified by parents as a source of trusted vaccine information and a strong provider recommendation is associated with vaccination, but not all families are receiving vaccine advice. In a 2022 Kaiser Family Foundation survey, parents of young children with annual household incomes above $90,000 were more likely to talk to their pediatrician about a COVID-19 vaccine than families with lower incomes.3Vaccine hesitancy, fueled by general confusion and skepticism, is another factor contributing to low vaccination rates. Admittedly, the recommendations are complex and on March 14, 2023, the FDA again revised the emergency-use authorization for young children. Some caregivers continue to express concerns about vaccine side effects as well as the belief that the vaccine won’t prevent their child from getting sick.
Kendall Purcell, MD, a pediatrician with Norton Children’s Medical Group in Louisville, Ky., recommends COVID-19 vaccination for her patients because it reduces the risk of severe disease. That factored into her own decision to vaccinate her 4-year-old son and 1-year-old daughter, but she hasn’t been able to convince the parents of all her patients. “Some feel that COVID-19 is not as severe for children, so the risks don’t outweigh the benefits when it comes to vaccinating their children.” Back to our case: In the ED the intern reviewed the laboratory testing she had ordered. She then sat down with the mother of the 3-year-old girl to discuss the diagnosis: febrile seizure associated with COVID-19 infection. Febrile seizures are a well-recognized but uncommon complication of COVID-19 in children. In a retrospective cohort study using electronic health record data, febrile seizures occurred in 0.5% of 8,854 children aged 0-5 years with COVID-19 infection.4 About 9% of these children required critical care services. In another cohort of hospitalized children, neurologic complications occurred in 7% of children hospitalized with COVID-19.5 Febrile and nonfebrile seizures were most commonly observed.
“I really thought COVID-19 was no big deal in young kids,” the mom said. “Parents need the facts.”
The facts are these: Through Dec. 2, 2022, more than 3 million cases of COVID-19 have been reported in children aged younger than 5 years. While COVID is generally less severe in young children than older adults, it is difficult to predict which children will become seriously ill. When children are hospitalized, one in four requires intensive care. COVID-19 is now a vaccine-preventable disease, but too many children remain unprotected.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta, and Gilead. Email her at [email protected]. Ms. Ezell is a recent graduate from Indiana University Southeast with a Bachelor of Arts in English. They have no conflicts of interest.
References
1. Fleming-Dutra KE et al. Morb Mortal Wkly Rep. 2023;72:177-182.
2. Murthy BP et al. Morb Mortal Wkly Rep. 2023;72:183-9.
3. Lopes L et al. KFF COVID-19 vaccine monitor: July 2022. San Francisco: Kaiser Family Foundation, 2022.
4. Cadet K et al. J Child Neurol. 2022 Apr;37(5):410-5.
5. Antoon JW et al. Pediatrics. 2022 Nov 1;150(5):e2022058167.
Case: A 3-year-old girl presented to the emergency department after a brief seizure at home. She looked well on physical exam except for a fever of 103° F and thick rhinorrhea.
The intern on duty methodically worked through the standard list of questions. “Immunizations up to date?” she asked.
“Absolutely,” the child’s mom responded. “She’s had everything that’s recommended.”
“Including COVID-19 vaccine?” the intern prompted.
“No.” The mom responded with a shake of her head. “We don’t do that vaccine.”
That mom is not alone.
COVID-19 vaccines for children as young as 6 months were given emergency-use authorization by the Food and Drug Administration in June 2022 and in February 2023, the Advisory Committee on Immunization Practices included COVID-19 vaccine on the routine childhood immunization schedule.
COVID-19 vaccines are safe in young children, and they prevent the most severe outcomes associated with infection, including hospitalization. Newly released data confirm that the COVID-19 vaccines produced by Moderna and Pfizer also provide protection against symptomatic infection for at least 4 months after completion of the monovalent primary series.
In a Morbidity and Mortality Weekly Report released on Feb. 17, 2023, the Centers for Disease Control and Prevention reported the results of a test-negative design case-control study that enrolled symptomatic children tested for SARS-CoV-2 infection through Feb. 5, 2023, as part of the Increasing Community Access to Testing (ICATT) program.1 ICATT provides SARS-CoV-2 testing to persons aged at least 3 years at pharmacy and community-based testing sites nationwide.
Two doses of monovalent Moderna vaccine (complete primary series) was 60% effective against symptomatic infection (95% confidence interval, 49%-68%) 2 weeks to 2 months after receipt of the second dose. Vaccine effectiveness dropped to 36% (95% CI, 15%-52%) 3-4 months after the second dose. Three doses of monovalent Pfizer-BioNTech vaccine (complete primary series) was 31% effective (95% CI, 7%-49%) at preventing symptomatic infection 2 weeks to 4 months after receipt of the third dose. A bivalent vaccine dose for eligible children is expected to provide more protection against currently circulating SARS-CoV-2 variants.
Despite evidence of vaccine efficacy, very few parents are opting to protect their young children with the COVID-19 vaccine. The CDC reports that, as of March 1, 2023, only 8% of children under 2 years and 10.5% of children aged 2-4 years have initiated a COVID vaccine series. The American Academy of Pediatrics has emphasized that 15.0 million children between the ages of 6 months and 4 years have not yet received their first COVID-19 vaccine dose.
While the reasons underlying low COVID-19 vaccination rates in young children are complex, themes emerge. Socioeconomic disparities contributing to low vaccination rates in young children were highlighted in another recent MMWR article.2 Through Dec. 1, 2022, vaccination coverage was lower in rural counties (3.4%) than in urban counties (10.5%). Rates were lower in Black and Hispanic children than in White and Asian children.
According to the CDC, high rates of poverty in Black and Hispanic communities may affect vaccination coverage by affecting caregivers’ access to vaccination sites or ability to leave work to take their child to be vaccinated. Pediatric care providers have repeatedly been identified by parents as a source of trusted vaccine information and a strong provider recommendation is associated with vaccination, but not all families are receiving vaccine advice. In a 2022 Kaiser Family Foundation survey, parents of young children with annual household incomes above $90,000 were more likely to talk to their pediatrician about a COVID-19 vaccine than families with lower incomes.3Vaccine hesitancy, fueled by general confusion and skepticism, is another factor contributing to low vaccination rates. Admittedly, the recommendations are complex and on March 14, 2023, the FDA again revised the emergency-use authorization for young children. Some caregivers continue to express concerns about vaccine side effects as well as the belief that the vaccine won’t prevent their child from getting sick.
Kendall Purcell, MD, a pediatrician with Norton Children’s Medical Group in Louisville, Ky., recommends COVID-19 vaccination for her patients because it reduces the risk of severe disease. That factored into her own decision to vaccinate her 4-year-old son and 1-year-old daughter, but she hasn’t been able to convince the parents of all her patients. “Some feel that COVID-19 is not as severe for children, so the risks don’t outweigh the benefits when it comes to vaccinating their children.” Back to our case: In the ED the intern reviewed the laboratory testing she had ordered. She then sat down with the mother of the 3-year-old girl to discuss the diagnosis: febrile seizure associated with COVID-19 infection. Febrile seizures are a well-recognized but uncommon complication of COVID-19 in children. In a retrospective cohort study using electronic health record data, febrile seizures occurred in 0.5% of 8,854 children aged 0-5 years with COVID-19 infection.4 About 9% of these children required critical care services. In another cohort of hospitalized children, neurologic complications occurred in 7% of children hospitalized with COVID-19.5 Febrile and nonfebrile seizures were most commonly observed.
“I really thought COVID-19 was no big deal in young kids,” the mom said. “Parents need the facts.”
The facts are these: Through Dec. 2, 2022, more than 3 million cases of COVID-19 have been reported in children aged younger than 5 years. While COVID is generally less severe in young children than older adults, it is difficult to predict which children will become seriously ill. When children are hospitalized, one in four requires intensive care. COVID-19 is now a vaccine-preventable disease, but too many children remain unprotected.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta, and Gilead. Email her at [email protected]. Ms. Ezell is a recent graduate from Indiana University Southeast with a Bachelor of Arts in English. They have no conflicts of interest.
References
1. Fleming-Dutra KE et al. Morb Mortal Wkly Rep. 2023;72:177-182.
2. Murthy BP et al. Morb Mortal Wkly Rep. 2023;72:183-9.
3. Lopes L et al. KFF COVID-19 vaccine monitor: July 2022. San Francisco: Kaiser Family Foundation, 2022.
4. Cadet K et al. J Child Neurol. 2022 Apr;37(5):410-5.
5. Antoon JW et al. Pediatrics. 2022 Nov 1;150(5):e2022058167.
CSU in children: Study identifies biomarkers associated with responses to different treatments
NEW ORLEANS – , results from a single-center prospective study showed.
“Given that the majority of CSU cases in adults are due to autoimmunity and there being very [few] studies on biomarkers for CSU in children, our study furthers our current understanding of the role of different biomarkers in treatment response,” lead study author Alex Nguyen, MsC, said in an interview at the annual meeting of the American Academy of Dermatology, where the study was presented during a poster session.
To identify biomarkers with treatment and disease resolution in children with CSU, Mr. Nguyen, a 4-year medical student at McGill University, Montreal, and colleagues prospectively recruited 109 children from the Montreal Children’s Hospital Allergy and Immunology Clinic who reported hives for at least 6 weeks from 2013 to 2022. They obtained levels of thyroid stimulating hormone (TSH), anti-thyroxine peroxidase (anti-TPO), total immunoglobulin E (IgE), CD63, tryptase, eosinophils, MPV, and platelets; the weekly urticaria activity score (UAS7) was recorded at study entry.
Levels of treatment included antihistamines at standard dose, four times the standard dose, omalizumab, and resolution of treatment. The researchers used univariate and multivariate logistic regressions to determine factors associated with different treatment levels and resolution.
Slightly more than half of the study participants (55%) were female, and their mean age was 9 years. Mr. Nguyen and colleagues observed that elevated MPV was associated with the four times increased dose of antihistamines treatment level (odds ratio = 1.052, 95% confidence interval = 1.004-1.103). Lower age was associated with disease resolution (OR = 0.982, 95% CI = 0.965-0.999).
After adjustment for age, sex, TSH, anti-TPO, total IgE, CD63, eosinophils, MPV, and platelets, elevated tryptase was associated with the antihistamine use at standard dose level (OR = 1.152, 95% CI = 1.019-1.302) and lower tryptase levels with disease resolution (OR = .861, 95% CI = 0.777-0.955).
“We were fascinated when we found that tryptase levels in patients with chronic spontaneous urticaria were associated with standard dose of antihistamines and even disease resolution,” Mr. Nguyen said. “Higher tryptase levels were associated with standard dose antihistamines, which potentially could imply an increase in mast cell activation. Furthermore, we saw that lower tryptase levels were associated with disease resolution likely given if the disease may not have been as severe.”
He acknowledged certain limitations of the study, including a limited sample size and an unbalanced sample size among treatment groups. In the future, he and his colleagues plan to increase the sample size and to include other biomarkers such as interleukin (IL)-6, D-dimer, vitamin D, and matrix mettaloproteinase-9.
“Much as the name suggests, CSU often arises without a clear trigger,” said Raj Chovatiya, MD, PhD, assistant professor in the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study. “Particularly in children, little is known about potential biomarkers that may guide treatment or disease resolution. While a larger, prospective analysis would better characterize temporal trends in serum biomarkers in relation to disease activity, these data suggest that underlying mechanisms of tryptase may be worth an in-depth look in children with CSU.”
The study was recognized as the second-best poster at the meeting. The researchers reported having no financial disclosures. The other study coauthors were Michelle Le MD, Sofianne Gabrielli MSc, Elena Netchiporouk, MD, MSc, and Moshe Ben-Shoshan, MD, MSc. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for several pharmaceutical companies.
NEW ORLEANS – , results from a single-center prospective study showed.
“Given that the majority of CSU cases in adults are due to autoimmunity and there being very [few] studies on biomarkers for CSU in children, our study furthers our current understanding of the role of different biomarkers in treatment response,” lead study author Alex Nguyen, MsC, said in an interview at the annual meeting of the American Academy of Dermatology, where the study was presented during a poster session.
To identify biomarkers with treatment and disease resolution in children with CSU, Mr. Nguyen, a 4-year medical student at McGill University, Montreal, and colleagues prospectively recruited 109 children from the Montreal Children’s Hospital Allergy and Immunology Clinic who reported hives for at least 6 weeks from 2013 to 2022. They obtained levels of thyroid stimulating hormone (TSH), anti-thyroxine peroxidase (anti-TPO), total immunoglobulin E (IgE), CD63, tryptase, eosinophils, MPV, and platelets; the weekly urticaria activity score (UAS7) was recorded at study entry.
Levels of treatment included antihistamines at standard dose, four times the standard dose, omalizumab, and resolution of treatment. The researchers used univariate and multivariate logistic regressions to determine factors associated with different treatment levels and resolution.
Slightly more than half of the study participants (55%) were female, and their mean age was 9 years. Mr. Nguyen and colleagues observed that elevated MPV was associated with the four times increased dose of antihistamines treatment level (odds ratio = 1.052, 95% confidence interval = 1.004-1.103). Lower age was associated with disease resolution (OR = 0.982, 95% CI = 0.965-0.999).
After adjustment for age, sex, TSH, anti-TPO, total IgE, CD63, eosinophils, MPV, and platelets, elevated tryptase was associated with the antihistamine use at standard dose level (OR = 1.152, 95% CI = 1.019-1.302) and lower tryptase levels with disease resolution (OR = .861, 95% CI = 0.777-0.955).
“We were fascinated when we found that tryptase levels in patients with chronic spontaneous urticaria were associated with standard dose of antihistamines and even disease resolution,” Mr. Nguyen said. “Higher tryptase levels were associated with standard dose antihistamines, which potentially could imply an increase in mast cell activation. Furthermore, we saw that lower tryptase levels were associated with disease resolution likely given if the disease may not have been as severe.”
He acknowledged certain limitations of the study, including a limited sample size and an unbalanced sample size among treatment groups. In the future, he and his colleagues plan to increase the sample size and to include other biomarkers such as interleukin (IL)-6, D-dimer, vitamin D, and matrix mettaloproteinase-9.
“Much as the name suggests, CSU often arises without a clear trigger,” said Raj Chovatiya, MD, PhD, assistant professor in the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study. “Particularly in children, little is known about potential biomarkers that may guide treatment or disease resolution. While a larger, prospective analysis would better characterize temporal trends in serum biomarkers in relation to disease activity, these data suggest that underlying mechanisms of tryptase may be worth an in-depth look in children with CSU.”
The study was recognized as the second-best poster at the meeting. The researchers reported having no financial disclosures. The other study coauthors were Michelle Le MD, Sofianne Gabrielli MSc, Elena Netchiporouk, MD, MSc, and Moshe Ben-Shoshan, MD, MSc. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for several pharmaceutical companies.
NEW ORLEANS – , results from a single-center prospective study showed.
“Given that the majority of CSU cases in adults are due to autoimmunity and there being very [few] studies on biomarkers for CSU in children, our study furthers our current understanding of the role of different biomarkers in treatment response,” lead study author Alex Nguyen, MsC, said in an interview at the annual meeting of the American Academy of Dermatology, where the study was presented during a poster session.
To identify biomarkers with treatment and disease resolution in children with CSU, Mr. Nguyen, a 4-year medical student at McGill University, Montreal, and colleagues prospectively recruited 109 children from the Montreal Children’s Hospital Allergy and Immunology Clinic who reported hives for at least 6 weeks from 2013 to 2022. They obtained levels of thyroid stimulating hormone (TSH), anti-thyroxine peroxidase (anti-TPO), total immunoglobulin E (IgE), CD63, tryptase, eosinophils, MPV, and platelets; the weekly urticaria activity score (UAS7) was recorded at study entry.
Levels of treatment included antihistamines at standard dose, four times the standard dose, omalizumab, and resolution of treatment. The researchers used univariate and multivariate logistic regressions to determine factors associated with different treatment levels and resolution.
Slightly more than half of the study participants (55%) were female, and their mean age was 9 years. Mr. Nguyen and colleagues observed that elevated MPV was associated with the four times increased dose of antihistamines treatment level (odds ratio = 1.052, 95% confidence interval = 1.004-1.103). Lower age was associated with disease resolution (OR = 0.982, 95% CI = 0.965-0.999).
After adjustment for age, sex, TSH, anti-TPO, total IgE, CD63, eosinophils, MPV, and platelets, elevated tryptase was associated with the antihistamine use at standard dose level (OR = 1.152, 95% CI = 1.019-1.302) and lower tryptase levels with disease resolution (OR = .861, 95% CI = 0.777-0.955).
“We were fascinated when we found that tryptase levels in patients with chronic spontaneous urticaria were associated with standard dose of antihistamines and even disease resolution,” Mr. Nguyen said. “Higher tryptase levels were associated with standard dose antihistamines, which potentially could imply an increase in mast cell activation. Furthermore, we saw that lower tryptase levels were associated with disease resolution likely given if the disease may not have been as severe.”
He acknowledged certain limitations of the study, including a limited sample size and an unbalanced sample size among treatment groups. In the future, he and his colleagues plan to increase the sample size and to include other biomarkers such as interleukin (IL)-6, D-dimer, vitamin D, and matrix mettaloproteinase-9.
“Much as the name suggests, CSU often arises without a clear trigger,” said Raj Chovatiya, MD, PhD, assistant professor in the department of dermatology at Northwestern University, Chicago, who was asked to comment on the study. “Particularly in children, little is known about potential biomarkers that may guide treatment or disease resolution. While a larger, prospective analysis would better characterize temporal trends in serum biomarkers in relation to disease activity, these data suggest that underlying mechanisms of tryptase may be worth an in-depth look in children with CSU.”
The study was recognized as the second-best poster at the meeting. The researchers reported having no financial disclosures. The other study coauthors were Michelle Le MD, Sofianne Gabrielli MSc, Elena Netchiporouk, MD, MSc, and Moshe Ben-Shoshan, MD, MSc. Dr. Chovatiya disclosed that he is a consultant to, a speaker for, and/or a member of the advisory board for several pharmaceutical companies.
AT AAD 2023
Cutting social media to 1 hour a day boosts self-image in young adults
“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.
“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.
“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 PSYCHOLOGY OF POPULAR MEDIA
Which recommendations on screening, diagnosing, and treating eating disorders are most helpful?
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.
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.
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.
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.
Artificial pancreas ‘superior’ in young kids with type 1 diabetes
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.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Lebrikizumab monotherapy for AD found safe, effective during induction
, 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.
, 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.
, 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.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
High school athletes sustaining worse injuries
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.