Pediatrics

With degrees in electrical engineering and computer science from the Massachusetts Institute of Technology, Nikhila Schroeder, MD, MEng, brings a problem-solving mindset to medicine.

Being a doctor means having to “figure out all aspects of [a patient’s] situation and do my best to come up with an answer,” said Dr. Schroeder, who founded Allergenuity Health, a solo allergy practice in Huntersville, N.C., with her husband James, who serves as practice executive. It’s “being a medical detective for your patient.”

Yet, during her training, Dr. Schroeder found that market-driven health care makes it hard to practice medicine with a patient’s best interest foremost. Procedures for diagnosing and treating disease cater to insurance companies’ reimbursement policies. “You wind up having to tailor your care to whatever insurance will cover,” she said.

Insurers, in turn, look for evidence from large, peer-reviewed studies to prove that a treatment works. Many physicians hesitate to offer therapies that aren’t covered by insurance, for both liability and financial reasons. So treatment tends to be limited to those options that were rigorously vetted in long, costly, multisite trials that are difficult to conduct without a corporate sponsor.

This is why there is still only one licensed treatment for people with food allergies – a set of standardized peanut powder capsules (Palforzia) that was approved by the Food and Drug Administration in early 2020 for peanut-allergic children aged 4-17 years. A small but growing number of allergists offer unapproved oral immunotherapy (OIT) using commercial food products to treat allergies to peanuts and other foods.

Even fewer allergists treat food allergy patients with another immune-modifying treatment, sublingual immunotherapy (SLIT), which delivers allergens through liquid drops held for several minutes under the tongue. Since 2018, Allergenuity Health, which offers SLIT to treat food and environmental allergies, has provided care to more than 400 patients. More than a third have come from out of state.

The clinic uses a direct-care approach. Rather than taking insurance, the clinic offers a monthly billing program that includes tests, SLIT bottles, and access to Dr. Schroeder via phone, email, or text. “I’m only contracted with the patient, and my only focus is the patient,” Dr. Schroeder said in an interview.
 

Unforgettable day

Allergy was not on Dr. Schroeder’s radar in medical school. She wanted to be a surgeon. But she loved working with children, so she did a pediatrics residency at the University of Virginia Children’s Hospital in Charlottesville. There Dr. Schroeder started seeing kids with eczema and allergies. While covering a friend’s clinic shift in 2010, she was thrust into an emergency. A family who didn’t speak English had just brought in their screaming 6-month-old baby, red and puffy with hives. “We didn’t know what was going on with this child,” Dr. Schroeder said. “Somehow I was elected to go in there.”

All of a sudden, things got quiet. Yet the baby was still screaming, mouth wide open. Dr. Schroeder had learned about anaphylaxis but had never witnessed it – until that day. The baby›s airways swelled so much that the crying became hoarse and soft. After working with a nurse to administer epinephrine, Dr. Schroeder saw something equally unforgettable: The baby’s heart rate soared, but within minutes the hives and swelling subsided and smiles returned. “It was incredible how quickly things changed,” Dr. Schroeder said. The baby had a reaction to rice, an uncommon allergen.

Dr. Schroeder stayed at UVA 2 more years to complete an allergy and immunology fellowship. She learned to diagnose food allergies but became frustrated having to tell patients they had little recourse but to avoid the food and to check in every year or 2. “I was, like, aren’t we specialists? Shouldn’t we have a little more expertise and maybe see if there are ways we could change this?” Dr. Schroeder said.

During those years, allergy shots were the only form of immunotherapy being taught to fellows. At clinic, Dr. Schroeder served as backup to the nurses when someone reacted to shots. She was troubled that some patients needed epinephrine to stop asthma attacks caused by injections they had received as treatment. The idea of injecting substances under the skin seemed akin to vaccination – where “you want to aggravate the immune system, you want it to get revved up, you want to build it up to fight,” she said. “But that’s not what you want for allergy. You want to tone it down. It didn’t really, to be honest, make a lot of sense to me.”

Dr. Schroeder started digging and asking questions. How does the immune system decide what is safe? Which cells and molecules communicate these decisions? She thought about babies and how they “learn” by putting stuff into their mouths. “If we don’t tolerate most of what we take in there, we wouldn’t survive,” Dr. Schroeder said. “It makes a lot of sense that a lot of tolerance begins with cells of the mouth.”

Dr. Schroeder discussed these concepts with her attendings. “They were all, like, no, there’s really no good evidence for that,” she said. But at some point, someone mentioned sublingual immunotherapy, and Schroeder came across Allergy Associates of La Crosse (Wis.).

The clinic’s late founder, David Morris, MD, learned about SLIT in the 1960s as an alternative option for farmers who suffered terrible side effects from injection immunotherapy they received to treat their mold allergies. Dr. Morris attended conferences, learned more about sublingual techniques – at times seeking advice from European allergists who offered SLIT – and became board certified in allergy before opening the La Crosse clinic in 1970. According to the clinic, more than 200,000 patients with environmental and food allergies have been treated with its SLIT protocol.

Dr. Schroeder was shocked to discover that this clinic had existed for 40 years, yet “I, as an allergist, had heard nothing about them,” she said.

Toward the end of her fellowship, OIT was becoming more well known. But she felt its risks were often downplayed. After years of talking with food allergy patients, Schroeder realized that most didn’t actually care about eating peanut butter sandwiches or sesame or walnuts. “Often I would hear, through tears: ‘I just want my child to be able to sit with their friends at lunch, to not be put at this other table, to not feel so isolated,’ ” she said. What mattered most to many families was gaining enough protection to not feel anxious about participating in social activities involving food.

Dr. Schroeder had a growing sense that SLIT – given its ease, safety, and sensible route of allergen delivery – seemed more useful. She wanted to learn more.

Her mentors urged her to stay in academia instead. “They were, like, you have a good academic reputation. You’re a solid thinker. You’re great at what you do. Do the traditional stuff,” Dr. Schroeder said.

Despite these admonitions, Dr. Schroeder left academia and took a job at La Crosse after completing her allergy fellowship. Determined to see whether SLIT could be effective, “I decided in the end, you know what, I have to go do this,” she said. “I need to know, and the only way I’m going to know is to do it, because no one was giving me good information.”

Before treating anyone with SLIT, Dr. Schroeder tried it herself – as a La Crosse patient. Growing up with severe eczema, eye swelling, and chronic nasal congestion leading to sinus infections, “I myself was a severely allergic person,” she said. Within several months, Dr. Schroeder saw dramatic improvement in her symptoms – “a night and day difference.” She experienced some mouth tingling, one of SLIT’s most common side effects, but found it “very tolerable, very mild.”

Allergenuity Health doesn’t aim to promote SLIT as the best treatment, said Dr. Schroeder, who has helped some families use avoidance or OIT as a better option. “An initial evaluation is always about proper diagnosis and education about all the treatment options available. Really, the point is education – be a detective for them and figure out what’s going on, be honest about what we know and what we don’t know, and give them the tools to figure out how to proceed.”

A version of this article first appeared on Medscape.com. This is part two of a three-part series. Part one is here. Part three is here.

With degrees in electrical engineering and computer science from the Massachusetts Institute of Technology, Nikhila Schroeder, MD, MEng, brings a problem-solving mindset to medicine.

Being a doctor means having to “figure out all aspects of [a patient’s] situation and do my best to come up with an answer,” said Dr. Schroeder, who founded Allergenuity Health, a solo allergy practice in Huntersville, N.C., with her husband James, who serves as practice executive. It’s “being a medical detective for your patient.”

Yet, during her training, Dr. Schroeder found that market-driven health care makes it hard to practice medicine with a patient’s best interest foremost. Procedures for diagnosing and treating disease cater to insurance companies’ reimbursement policies. “You wind up having to tailor your care to whatever insurance will cover,” she said.

Insurers, in turn, look for evidence from large, peer-reviewed studies to prove that a treatment works. Many physicians hesitate to offer therapies that aren’t covered by insurance, for both liability and financial reasons. So treatment tends to be limited to those options that were rigorously vetted in long, costly, multisite trials that are difficult to conduct without a corporate sponsor.

This is why there is still only one licensed treatment for people with food allergies – a set of standardized peanut powder capsules (Palforzia) that was approved by the Food and Drug Administration in early 2020 for peanut-allergic children aged 4-17 years. A small but growing number of allergists offer unapproved oral immunotherapy (OIT) using commercial food products to treat allergies to peanuts and other foods.

Even fewer allergists treat food allergy patients with another immune-modifying treatment, sublingual immunotherapy (SLIT), which delivers allergens through liquid drops held for several minutes under the tongue. Since 2018, Allergenuity Health, which offers SLIT to treat food and environmental allergies, has provided care to more than 400 patients. More than a third have come from out of state.

The clinic uses a direct-care approach. Rather than taking insurance, the clinic offers a monthly billing program that includes tests, SLIT bottles, and access to Dr. Schroeder via phone, email, or text. “I’m only contracted with the patient, and my only focus is the patient,” Dr. Schroeder said in an interview.
 

Unforgettable day

Allergy was not on Dr. Schroeder’s radar in medical school. She wanted to be a surgeon. But she loved working with children, so she did a pediatrics residency at the University of Virginia Children’s Hospital in Charlottesville. There Dr. Schroeder started seeing kids with eczema and allergies. While covering a friend’s clinic shift in 2010, she was thrust into an emergency. A family who didn’t speak English had just brought in their screaming 6-month-old baby, red and puffy with hives. “We didn’t know what was going on with this child,” Dr. Schroeder said. “Somehow I was elected to go in there.”

All of a sudden, things got quiet. Yet the baby was still screaming, mouth wide open. Dr. Schroeder had learned about anaphylaxis but had never witnessed it – until that day. The baby›s airways swelled so much that the crying became hoarse and soft. After working with a nurse to administer epinephrine, Dr. Schroeder saw something equally unforgettable: The baby’s heart rate soared, but within minutes the hives and swelling subsided and smiles returned. “It was incredible how quickly things changed,” Dr. Schroeder said. The baby had a reaction to rice, an uncommon allergen.

Dr. Schroeder stayed at UVA 2 more years to complete an allergy and immunology fellowship. She learned to diagnose food allergies but became frustrated having to tell patients they had little recourse but to avoid the food and to check in every year or 2. “I was, like, aren’t we specialists? Shouldn’t we have a little more expertise and maybe see if there are ways we could change this?” Dr. Schroeder said.

During those years, allergy shots were the only form of immunotherapy being taught to fellows. At clinic, Dr. Schroeder served as backup to the nurses when someone reacted to shots. She was troubled that some patients needed epinephrine to stop asthma attacks caused by injections they had received as treatment. The idea of injecting substances under the skin seemed akin to vaccination – where “you want to aggravate the immune system, you want it to get revved up, you want to build it up to fight,” she said. “But that’s not what you want for allergy. You want to tone it down. It didn’t really, to be honest, make a lot of sense to me.”

Dr. Schroeder started digging and asking questions. How does the immune system decide what is safe? Which cells and molecules communicate these decisions? She thought about babies and how they “learn” by putting stuff into their mouths. “If we don’t tolerate most of what we take in there, we wouldn’t survive,” Dr. Schroeder said. “It makes a lot of sense that a lot of tolerance begins with cells of the mouth.”

Dr. Schroeder discussed these concepts with her attendings. “They were all, like, no, there’s really no good evidence for that,” she said. But at some point, someone mentioned sublingual immunotherapy, and Schroeder came across Allergy Associates of La Crosse (Wis.).

The clinic’s late founder, David Morris, MD, learned about SLIT in the 1960s as an alternative option for farmers who suffered terrible side effects from injection immunotherapy they received to treat their mold allergies. Dr. Morris attended conferences, learned more about sublingual techniques – at times seeking advice from European allergists who offered SLIT – and became board certified in allergy before opening the La Crosse clinic in 1970. According to the clinic, more than 200,000 patients with environmental and food allergies have been treated with its SLIT protocol.

Dr. Schroeder was shocked to discover that this clinic had existed for 40 years, yet “I, as an allergist, had heard nothing about them,” she said.

Toward the end of her fellowship, OIT was becoming more well known. But she felt its risks were often downplayed. After years of talking with food allergy patients, Schroeder realized that most didn’t actually care about eating peanut butter sandwiches or sesame or walnuts. “Often I would hear, through tears: ‘I just want my child to be able to sit with their friends at lunch, to not be put at this other table, to not feel so isolated,’ ” she said. What mattered most to many families was gaining enough protection to not feel anxious about participating in social activities involving food.

Dr. Schroeder had a growing sense that SLIT – given its ease, safety, and sensible route of allergen delivery – seemed more useful. She wanted to learn more.

Her mentors urged her to stay in academia instead. “They were, like, you have a good academic reputation. You’re a solid thinker. You’re great at what you do. Do the traditional stuff,” Dr. Schroeder said.

Despite these admonitions, Dr. Schroeder left academia and took a job at La Crosse after completing her allergy fellowship. Determined to see whether SLIT could be effective, “I decided in the end, you know what, I have to go do this,” she said. “I need to know, and the only way I’m going to know is to do it, because no one was giving me good information.”

Before treating anyone with SLIT, Dr. Schroeder tried it herself – as a La Crosse patient. Growing up with severe eczema, eye swelling, and chronic nasal congestion leading to sinus infections, “I myself was a severely allergic person,” she said. Within several months, Dr. Schroeder saw dramatic improvement in her symptoms – “a night and day difference.” She experienced some mouth tingling, one of SLIT’s most common side effects, but found it “very tolerable, very mild.”

Allergenuity Health doesn’t aim to promote SLIT as the best treatment, said Dr. Schroeder, who has helped some families use avoidance or OIT as a better option. “An initial evaluation is always about proper diagnosis and education about all the treatment options available. Really, the point is education – be a detective for them and figure out what’s going on, be honest about what we know and what we don’t know, and give them the tools to figure out how to proceed.”

A version of this article first appeared on Medscape.com. This is part two of a three-part series. Part one is here. Part three is here.

With degrees in electrical engineering and computer science from the Massachusetts Institute of Technology, Nikhila Schroeder, MD, MEng, brings a problem-solving mindset to medicine.

Being a doctor means having to “figure out all aspects of [a patient’s] situation and do my best to come up with an answer,” said Dr. Schroeder, who founded Allergenuity Health, a solo allergy practice in Huntersville, N.C., with her husband James, who serves as practice executive. It’s “being a medical detective for your patient.”

Yet, during her training, Dr. Schroeder found that market-driven health care makes it hard to practice medicine with a patient’s best interest foremost. Procedures for diagnosing and treating disease cater to insurance companies’ reimbursement policies. “You wind up having to tailor your care to whatever insurance will cover,” she said.

Insurers, in turn, look for evidence from large, peer-reviewed studies to prove that a treatment works. Many physicians hesitate to offer therapies that aren’t covered by insurance, for both liability and financial reasons. So treatment tends to be limited to those options that were rigorously vetted in long, costly, multisite trials that are difficult to conduct without a corporate sponsor.

This is why there is still only one licensed treatment for people with food allergies – a set of standardized peanut powder capsules (Palforzia) that was approved by the Food and Drug Administration in early 2020 for peanut-allergic children aged 4-17 years. A small but growing number of allergists offer unapproved oral immunotherapy (OIT) using commercial food products to treat allergies to peanuts and other foods.

Even fewer allergists treat food allergy patients with another immune-modifying treatment, sublingual immunotherapy (SLIT), which delivers allergens through liquid drops held for several minutes under the tongue. Since 2018, Allergenuity Health, which offers SLIT to treat food and environmental allergies, has provided care to more than 400 patients. More than a third have come from out of state.

The clinic uses a direct-care approach. Rather than taking insurance, the clinic offers a monthly billing program that includes tests, SLIT bottles, and access to Dr. Schroeder via phone, email, or text. “I’m only contracted with the patient, and my only focus is the patient,” Dr. Schroeder said in an interview.
 

Unforgettable day

Allergy was not on Dr. Schroeder’s radar in medical school. She wanted to be a surgeon. But she loved working with children, so she did a pediatrics residency at the University of Virginia Children’s Hospital in Charlottesville. There Dr. Schroeder started seeing kids with eczema and allergies. While covering a friend’s clinic shift in 2010, she was thrust into an emergency. A family who didn’t speak English had just brought in their screaming 6-month-old baby, red and puffy with hives. “We didn’t know what was going on with this child,” Dr. Schroeder said. “Somehow I was elected to go in there.”

All of a sudden, things got quiet. Yet the baby was still screaming, mouth wide open. Dr. Schroeder had learned about anaphylaxis but had never witnessed it – until that day. The baby›s airways swelled so much that the crying became hoarse and soft. After working with a nurse to administer epinephrine, Dr. Schroeder saw something equally unforgettable: The baby’s heart rate soared, but within minutes the hives and swelling subsided and smiles returned. “It was incredible how quickly things changed,” Dr. Schroeder said. The baby had a reaction to rice, an uncommon allergen.

Dr. Schroeder stayed at UVA 2 more years to complete an allergy and immunology fellowship. She learned to diagnose food allergies but became frustrated having to tell patients they had little recourse but to avoid the food and to check in every year or 2. “I was, like, aren’t we specialists? Shouldn’t we have a little more expertise and maybe see if there are ways we could change this?” Dr. Schroeder said.

During those years, allergy shots were the only form of immunotherapy being taught to fellows. At clinic, Dr. Schroeder served as backup to the nurses when someone reacted to shots. She was troubled that some patients needed epinephrine to stop asthma attacks caused by injections they had received as treatment. The idea of injecting substances under the skin seemed akin to vaccination – where “you want to aggravate the immune system, you want it to get revved up, you want to build it up to fight,” she said. “But that’s not what you want for allergy. You want to tone it down. It didn’t really, to be honest, make a lot of sense to me.”

Dr. Schroeder started digging and asking questions. How does the immune system decide what is safe? Which cells and molecules communicate these decisions? She thought about babies and how they “learn” by putting stuff into their mouths. “If we don’t tolerate most of what we take in there, we wouldn’t survive,” Dr. Schroeder said. “It makes a lot of sense that a lot of tolerance begins with cells of the mouth.”

Dr. Schroeder discussed these concepts with her attendings. “They were all, like, no, there’s really no good evidence for that,” she said. But at some point, someone mentioned sublingual immunotherapy, and Schroeder came across Allergy Associates of La Crosse (Wis.).

The clinic’s late founder, David Morris, MD, learned about SLIT in the 1960s as an alternative option for farmers who suffered terrible side effects from injection immunotherapy they received to treat their mold allergies. Dr. Morris attended conferences, learned more about sublingual techniques – at times seeking advice from European allergists who offered SLIT – and became board certified in allergy before opening the La Crosse clinic in 1970. According to the clinic, more than 200,000 patients with environmental and food allergies have been treated with its SLIT protocol.

Dr. Schroeder was shocked to discover that this clinic had existed for 40 years, yet “I, as an allergist, had heard nothing about them,” she said.

Toward the end of her fellowship, OIT was becoming more well known. But she felt its risks were often downplayed. After years of talking with food allergy patients, Schroeder realized that most didn’t actually care about eating peanut butter sandwiches or sesame or walnuts. “Often I would hear, through tears: ‘I just want my child to be able to sit with their friends at lunch, to not be put at this other table, to not feel so isolated,’ ” she said. What mattered most to many families was gaining enough protection to not feel anxious about participating in social activities involving food.

Dr. Schroeder had a growing sense that SLIT – given its ease, safety, and sensible route of allergen delivery – seemed more useful. She wanted to learn more.

Her mentors urged her to stay in academia instead. “They were, like, you have a good academic reputation. You’re a solid thinker. You’re great at what you do. Do the traditional stuff,” Dr. Schroeder said.

Despite these admonitions, Dr. Schroeder left academia and took a job at La Crosse after completing her allergy fellowship. Determined to see whether SLIT could be effective, “I decided in the end, you know what, I have to go do this,” she said. “I need to know, and the only way I’m going to know is to do it, because no one was giving me good information.”

Before treating anyone with SLIT, Dr. Schroeder tried it herself – as a La Crosse patient. Growing up with severe eczema, eye swelling, and chronic nasal congestion leading to sinus infections, “I myself was a severely allergic person,” she said. Within several months, Dr. Schroeder saw dramatic improvement in her symptoms – “a night and day difference.” She experienced some mouth tingling, one of SLIT’s most common side effects, but found it “very tolerable, very mild.”

Allergenuity Health doesn’t aim to promote SLIT as the best treatment, said Dr. Schroeder, who has helped some families use avoidance or OIT as a better option. “An initial evaluation is always about proper diagnosis and education about all the treatment options available. Really, the point is education – be a detective for them and figure out what’s going on, be honest about what we know and what we don’t know, and give them the tools to figure out how to proceed.”

A version of this article first appeared on Medscape.com. This is part two of a three-part series. Part one is here. Part three is here.

For the 32 million people in the United States with food allergies, those who seek relief beyond constant vigilance and EpiPens face a confusing treatment landscape. In January 2020, the Food and Drug Administration approved an oral immunotherapy product (Palforzia) for peanut-allergic children. Yet the product’s ill-timed release during a pandemic and its black-box warning about the risk for anaphylaxis has slowed uptake.

A small number of allergists offer home-grown oral immunotherapy (OIT), which builds protection by exposing patients to increasing daily doses of commercial food products over months. However, as with Palforzia, allergic reactions are common during treatment, and the hard-earned protection can fade if not maintained with regular dosing.

An alternate approach, sublingual immunotherapy (SLIT), delivers food proteins through liquid drops held in the mouth – a site rich in tolerance-inducing immune cells. In a 2019 study of peanut-allergic children aged 1-11 years, SLIT offered a level of protection on par with Palforzia while causing considerably fewer adverse events. And at the 2021 annual meeting of the American Academy of Allergy, Asthma and Immunology, researchers reported that SLIT produced stronger, more durable benefits in toddlers aged 1-4.

Sublingual immunotherapy is “a bunch of drops you put under your tongue, you hold it for a couple minutes, and then you’re done for the day,” said Edwin Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill, who led the two recent studies. For protecting against accidental ingestions, SLIT “is pushing pretty close to what OIT is able to provide but seemingly with a superior ease of administration and safety profile.”

Many parents don’t necessarily want their allergic kids to be able to eat a peanut butter sandwich – but do want them to be able to safely sit at the same lunch table and attend birthday parties with other kids. SLIT achieves this level of protection about as well as OIT, with fewer side effects.

Still, because of concerns about the treatment’s cost, unclear dosing regimens, and lack of FDA approval, very few U.S. allergists – likely less than 5% – offer sublingual immunotherapy to treat food allergies, making SLIT even less available than OIT.
 

Concerns about SLIT

One possible reason: Success is slower and less visible for SLIT. When patients undergo OIT, they build up to dosing with the actual food. “To a family who has a concern about their kid reacting, they can see them eating chunks of peanut in our office. That is really encouraging,” said Douglas Mack, MD, FRCPC, an allergist with Halton Pediatric Allergy and assistant clinical professor of pediatrics at McMaster University, Hamilton, Ont.

On the other hand, ingestion isn’t the focus for SLIT, so progress is harder to measure using metrics in published trials. After holding SLIT drops under the tongue, some patients spit them out. If they swallow the dose, it’s a vanishingly small amount. Immune changes that reflect increasing tolerance, such as a decrease in IgE antibodies, tend to be more gradual with SLIT than with OIT. And because SLIT is only offered in private clinics, such tests are not conducted as regularly as they would be for published trials.

But there may be a bigger factor: Some think earlier trials comparing the two immunotherapy regimens gave SLIT a bad rap. For example, in studies of milk- and peanut-allergic children conducted in 2011 and 2014, investigators concluded that SLIT was safer and that OIT appeared to be more effective. However, those trials compared SLIT with OIT using a much higher dose (2,000 mg) than is used in the licensed product (300 mg).

Over the years, endpoints for food allergy treatment trials have shifted from enabling patients to eat a full serving of their allergen to merely raising their threshold to guard against accidental exposures. So in those earlier articles, “we would probably write the discussion section differently now,” said Corinne Keet, MD, PhD, first author on the 2011 milk study and an associate professor of pediatrics at Johns Hopkins University, Baltimore.

Indeed, “when you compare [SLIT] to Palforzia or other studies of low-dose OIT (300 mg/d), they look equal in terms of their efficacy,” said senior author Robert Wood, MD, professor of pediatrics and director of pediatric allergy and immunology at Johns Hopkins. Yet, “I’m afraid we had a major [negative] impact on pharma’s interest in pursuing SLIT.”

Without corporate funding, it’s nearly impossible to conduct the large, multisite trials required for FDA approval of a treatment. And without approved products, many allergists are reluctant to offer the therapy, Dr. Wood said. It “makes your life a lot more complicated to be dabbling in things that are not approved,” he noted.

But at least one company is giving it a go. Applying the SLIT principle of delivering food allergens to tolerance-promoting immune cells in the mouth, New York–based Intrommune Therapeutics recently started enrolling peanut-allergic adults for a phase 1 trial of its experimental toothpaste.

Interest in food-allergy SLIT seems to be growing. “I definitely think that it could be an option for the future,” said Jaclyn Bjelac, MD, associate director of the Food Allergy Center of Excellence at the Cleveland Clinic. “Up until a few months ago, it really wasn’t on our radar.”

On conversations with Dr. Kim, philanthropists and drug developers said they found the recent data on SLIT promising, yet pointed out that food SLIT protocols and products are already in the public domain – they are described in published research using allergen extracts that are on the market. They “can’t see a commercial path forward,” Dr. Kim said in an interview. “And that’s kind of where many of my conversations end.”

Although there are no licensed SLIT products for food allergies, between 2014 and 2017, the FDA approved four sublingual immunotherapy tablets to treat environmental allergies – Stallergenes-Greer’s Oralair and ALK’s Grastek for grass pollens, ALK’s Odactra for dust mites, and ALK’s Ragwitek for short ragweed.

SLIT tablets work as well as allergy shots (subcutaneous immunotherapy) for controlling environmental allergy symptoms, they have a better safety profile, according to AAAAI guidelines, and they can be self-administered at home, which has made them a popular option globally. “Our European colleagues have used sublingual immunotherapy much more frequently than, for example, in the U.S.,” said Kari Nadeau, MD, PhD, director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.

Use of SLIT is also increasing in the United States, especially as FDA-approved products become available. In a 2019 survey, the percentage of U.S. allergists who said they were offering sublingual treatment for environmental allergies increased from 5.9% in 2007 to 73.5% in 2019. However, only 11.2% reported extensive SLIT use; the remainder reported some (50.5%) or little (38.3%) use.

As noted above, considerably fewer U.S. allergists use SLIT to treat food allergies. Similarly, a 2021 survey of allergists in Canada found that only 7% offered food sublingual immunotherapy; more than half reported offering OIT.

One practice, Allergy Associates of La Crosse (Wis.), has offered SLIT drops for food and environmental allergies for decades. Since the clinic opened in 1970, more than 200,000 people have been treated with its protocol. Every patient receives customized sublingual drops – “exactly what they’re allergic to, exactly how allergic they are, and then we build from there,” said Jeff Kessler, MBA, FACHE, practice executive at Allergy Associates of La Crosse. “Quite frankly, it’s the way immunotherapy should be done.

A version of this article first appeared on Medscape.com. This is part one of a three-part series. Part two is here. Part three is here.

For the 32 million people in the United States with food allergies, those who seek relief beyond constant vigilance and EpiPens face a confusing treatment landscape. In January 2020, the Food and Drug Administration approved an oral immunotherapy product (Palforzia) for peanut-allergic children. Yet the product’s ill-timed release during a pandemic and its black-box warning about the risk for anaphylaxis has slowed uptake.

A small number of allergists offer home-grown oral immunotherapy (OIT), which builds protection by exposing patients to increasing daily doses of commercial food products over months. However, as with Palforzia, allergic reactions are common during treatment, and the hard-earned protection can fade if not maintained with regular dosing.

An alternate approach, sublingual immunotherapy (SLIT), delivers food proteins through liquid drops held in the mouth – a site rich in tolerance-inducing immune cells. In a 2019 study of peanut-allergic children aged 1-11 years, SLIT offered a level of protection on par with Palforzia while causing considerably fewer adverse events. And at the 2021 annual meeting of the American Academy of Allergy, Asthma and Immunology, researchers reported that SLIT produced stronger, more durable benefits in toddlers aged 1-4.

Sublingual immunotherapy is “a bunch of drops you put under your tongue, you hold it for a couple minutes, and then you’re done for the day,” said Edwin Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill, who led the two recent studies. For protecting against accidental ingestions, SLIT “is pushing pretty close to what OIT is able to provide but seemingly with a superior ease of administration and safety profile.”

Many parents don’t necessarily want their allergic kids to be able to eat a peanut butter sandwich – but do want them to be able to safely sit at the same lunch table and attend birthday parties with other kids. SLIT achieves this level of protection about as well as OIT, with fewer side effects.

Still, because of concerns about the treatment’s cost, unclear dosing regimens, and lack of FDA approval, very few U.S. allergists – likely less than 5% – offer sublingual immunotherapy to treat food allergies, making SLIT even less available than OIT.
 

Concerns about SLIT

One possible reason: Success is slower and less visible for SLIT. When patients undergo OIT, they build up to dosing with the actual food. “To a family who has a concern about their kid reacting, they can see them eating chunks of peanut in our office. That is really encouraging,” said Douglas Mack, MD, FRCPC, an allergist with Halton Pediatric Allergy and assistant clinical professor of pediatrics at McMaster University, Hamilton, Ont.

On the other hand, ingestion isn’t the focus for SLIT, so progress is harder to measure using metrics in published trials. After holding SLIT drops under the tongue, some patients spit them out. If they swallow the dose, it’s a vanishingly small amount. Immune changes that reflect increasing tolerance, such as a decrease in IgE antibodies, tend to be more gradual with SLIT than with OIT. And because SLIT is only offered in private clinics, such tests are not conducted as regularly as they would be for published trials.

But there may be a bigger factor: Some think earlier trials comparing the two immunotherapy regimens gave SLIT a bad rap. For example, in studies of milk- and peanut-allergic children conducted in 2011 and 2014, investigators concluded that SLIT was safer and that OIT appeared to be more effective. However, those trials compared SLIT with OIT using a much higher dose (2,000 mg) than is used in the licensed product (300 mg).

Over the years, endpoints for food allergy treatment trials have shifted from enabling patients to eat a full serving of their allergen to merely raising their threshold to guard against accidental exposures. So in those earlier articles, “we would probably write the discussion section differently now,” said Corinne Keet, MD, PhD, first author on the 2011 milk study and an associate professor of pediatrics at Johns Hopkins University, Baltimore.

Indeed, “when you compare [SLIT] to Palforzia or other studies of low-dose OIT (300 mg/d), they look equal in terms of their efficacy,” said senior author Robert Wood, MD, professor of pediatrics and director of pediatric allergy and immunology at Johns Hopkins. Yet, “I’m afraid we had a major [negative] impact on pharma’s interest in pursuing SLIT.”

Without corporate funding, it’s nearly impossible to conduct the large, multisite trials required for FDA approval of a treatment. And without approved products, many allergists are reluctant to offer the therapy, Dr. Wood said. It “makes your life a lot more complicated to be dabbling in things that are not approved,” he noted.

But at least one company is giving it a go. Applying the SLIT principle of delivering food allergens to tolerance-promoting immune cells in the mouth, New York–based Intrommune Therapeutics recently started enrolling peanut-allergic adults for a phase 1 trial of its experimental toothpaste.

Interest in food-allergy SLIT seems to be growing. “I definitely think that it could be an option for the future,” said Jaclyn Bjelac, MD, associate director of the Food Allergy Center of Excellence at the Cleveland Clinic. “Up until a few months ago, it really wasn’t on our radar.”

On conversations with Dr. Kim, philanthropists and drug developers said they found the recent data on SLIT promising, yet pointed out that food SLIT protocols and products are already in the public domain – they are described in published research using allergen extracts that are on the market. They “can’t see a commercial path forward,” Dr. Kim said in an interview. “And that’s kind of where many of my conversations end.”

Although there are no licensed SLIT products for food allergies, between 2014 and 2017, the FDA approved four sublingual immunotherapy tablets to treat environmental allergies – Stallergenes-Greer’s Oralair and ALK’s Grastek for grass pollens, ALK’s Odactra for dust mites, and ALK’s Ragwitek for short ragweed.

SLIT tablets work as well as allergy shots (subcutaneous immunotherapy) for controlling environmental allergy symptoms, they have a better safety profile, according to AAAAI guidelines, and they can be self-administered at home, which has made them a popular option globally. “Our European colleagues have used sublingual immunotherapy much more frequently than, for example, in the U.S.,” said Kari Nadeau, MD, PhD, director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.

Use of SLIT is also increasing in the United States, especially as FDA-approved products become available. In a 2019 survey, the percentage of U.S. allergists who said they were offering sublingual treatment for environmental allergies increased from 5.9% in 2007 to 73.5% in 2019. However, only 11.2% reported extensive SLIT use; the remainder reported some (50.5%) or little (38.3%) use.

As noted above, considerably fewer U.S. allergists use SLIT to treat food allergies. Similarly, a 2021 survey of allergists in Canada found that only 7% offered food sublingual immunotherapy; more than half reported offering OIT.

One practice, Allergy Associates of La Crosse (Wis.), has offered SLIT drops for food and environmental allergies for decades. Since the clinic opened in 1970, more than 200,000 people have been treated with its protocol. Every patient receives customized sublingual drops – “exactly what they’re allergic to, exactly how allergic they are, and then we build from there,” said Jeff Kessler, MBA, FACHE, practice executive at Allergy Associates of La Crosse. “Quite frankly, it’s the way immunotherapy should be done.

A version of this article first appeared on Medscape.com. This is part one of a three-part series. Part two is here. Part three is here.

For the 32 million people in the United States with food allergies, those who seek relief beyond constant vigilance and EpiPens face a confusing treatment landscape. In January 2020, the Food and Drug Administration approved an oral immunotherapy product (Palforzia) for peanut-allergic children. Yet the product’s ill-timed release during a pandemic and its black-box warning about the risk for anaphylaxis has slowed uptake.

A small number of allergists offer home-grown oral immunotherapy (OIT), which builds protection by exposing patients to increasing daily doses of commercial food products over months. However, as with Palforzia, allergic reactions are common during treatment, and the hard-earned protection can fade if not maintained with regular dosing.

An alternate approach, sublingual immunotherapy (SLIT), delivers food proteins through liquid drops held in the mouth – a site rich in tolerance-inducing immune cells. In a 2019 study of peanut-allergic children aged 1-11 years, SLIT offered a level of protection on par with Palforzia while causing considerably fewer adverse events. And at the 2021 annual meeting of the American Academy of Allergy, Asthma and Immunology, researchers reported that SLIT produced stronger, more durable benefits in toddlers aged 1-4.

Sublingual immunotherapy is “a bunch of drops you put under your tongue, you hold it for a couple minutes, and then you’re done for the day,” said Edwin Kim, MD, director of the UNC Food Allergy Initiative, University of North Carolina at Chapel Hill, who led the two recent studies. For protecting against accidental ingestions, SLIT “is pushing pretty close to what OIT is able to provide but seemingly with a superior ease of administration and safety profile.”

Many parents don’t necessarily want their allergic kids to be able to eat a peanut butter sandwich – but do want them to be able to safely sit at the same lunch table and attend birthday parties with other kids. SLIT achieves this level of protection about as well as OIT, with fewer side effects.

Still, because of concerns about the treatment’s cost, unclear dosing regimens, and lack of FDA approval, very few U.S. allergists – likely less than 5% – offer sublingual immunotherapy to treat food allergies, making SLIT even less available than OIT.
 

Concerns about SLIT

One possible reason: Success is slower and less visible for SLIT. When patients undergo OIT, they build up to dosing with the actual food. “To a family who has a concern about their kid reacting, they can see them eating chunks of peanut in our office. That is really encouraging,” said Douglas Mack, MD, FRCPC, an allergist with Halton Pediatric Allergy and assistant clinical professor of pediatrics at McMaster University, Hamilton, Ont.

On the other hand, ingestion isn’t the focus for SLIT, so progress is harder to measure using metrics in published trials. After holding SLIT drops under the tongue, some patients spit them out. If they swallow the dose, it’s a vanishingly small amount. Immune changes that reflect increasing tolerance, such as a decrease in IgE antibodies, tend to be more gradual with SLIT than with OIT. And because SLIT is only offered in private clinics, such tests are not conducted as regularly as they would be for published trials.

But there may be a bigger factor: Some think earlier trials comparing the two immunotherapy regimens gave SLIT a bad rap. For example, in studies of milk- and peanut-allergic children conducted in 2011 and 2014, investigators concluded that SLIT was safer and that OIT appeared to be more effective. However, those trials compared SLIT with OIT using a much higher dose (2,000 mg) than is used in the licensed product (300 mg).

Over the years, endpoints for food allergy treatment trials have shifted from enabling patients to eat a full serving of their allergen to merely raising their threshold to guard against accidental exposures. So in those earlier articles, “we would probably write the discussion section differently now,” said Corinne Keet, MD, PhD, first author on the 2011 milk study and an associate professor of pediatrics at Johns Hopkins University, Baltimore.

Indeed, “when you compare [SLIT] to Palforzia or other studies of low-dose OIT (300 mg/d), they look equal in terms of their efficacy,” said senior author Robert Wood, MD, professor of pediatrics and director of pediatric allergy and immunology at Johns Hopkins. Yet, “I’m afraid we had a major [negative] impact on pharma’s interest in pursuing SLIT.”

Without corporate funding, it’s nearly impossible to conduct the large, multisite trials required for FDA approval of a treatment. And without approved products, many allergists are reluctant to offer the therapy, Dr. Wood said. It “makes your life a lot more complicated to be dabbling in things that are not approved,” he noted.

But at least one company is giving it a go. Applying the SLIT principle of delivering food allergens to tolerance-promoting immune cells in the mouth, New York–based Intrommune Therapeutics recently started enrolling peanut-allergic adults for a phase 1 trial of its experimental toothpaste.

Interest in food-allergy SLIT seems to be growing. “I definitely think that it could be an option for the future,” said Jaclyn Bjelac, MD, associate director of the Food Allergy Center of Excellence at the Cleveland Clinic. “Up until a few months ago, it really wasn’t on our radar.”

On conversations with Dr. Kim, philanthropists and drug developers said they found the recent data on SLIT promising, yet pointed out that food SLIT protocols and products are already in the public domain – they are described in published research using allergen extracts that are on the market. They “can’t see a commercial path forward,” Dr. Kim said in an interview. “And that’s kind of where many of my conversations end.”

Although there are no licensed SLIT products for food allergies, between 2014 and 2017, the FDA approved four sublingual immunotherapy tablets to treat environmental allergies – Stallergenes-Greer’s Oralair and ALK’s Grastek for grass pollens, ALK’s Odactra for dust mites, and ALK’s Ragwitek for short ragweed.

SLIT tablets work as well as allergy shots (subcutaneous immunotherapy) for controlling environmental allergy symptoms, they have a better safety profile, according to AAAAI guidelines, and they can be self-administered at home, which has made them a popular option globally. “Our European colleagues have used sublingual immunotherapy much more frequently than, for example, in the U.S.,” said Kari Nadeau, MD, PhD, director of the Sean N. Parker Center for Allergy and Asthma Research at Stanford (Calif.) University.

Use of SLIT is also increasing in the United States, especially as FDA-approved products become available. In a 2019 survey, the percentage of U.S. allergists who said they were offering sublingual treatment for environmental allergies increased from 5.9% in 2007 to 73.5% in 2019. However, only 11.2% reported extensive SLIT use; the remainder reported some (50.5%) or little (38.3%) use.

As noted above, considerably fewer U.S. allergists use SLIT to treat food allergies. Similarly, a 2021 survey of allergists in Canada found that only 7% offered food sublingual immunotherapy; more than half reported offering OIT.

One practice, Allergy Associates of La Crosse (Wis.), has offered SLIT drops for food and environmental allergies for decades. Since the clinic opened in 1970, more than 200,000 people have been treated with its protocol. Every patient receives customized sublingual drops – “exactly what they’re allergic to, exactly how allergic they are, and then we build from there,” said Jeff Kessler, MBA, FACHE, practice executive at Allergy Associates of La Crosse. “Quite frankly, it’s the way immunotherapy should be done.

A version of this article first appeared on Medscape.com. This is part one of a three-part series. Part two is here. Part three is here.

Suicide-risk screening may identify cases that typically fall through the cracks during depression screening, new research suggests.

The study, published in Pediatrics, found that the Ask Suicide-Screening Questions (ASQ) identified 2.2% of additional cases compared with those screened for any type of depression or other mental illnesses, and 8.3% of additional cases compared with those who screened positive for major depressive disorder.

About 3.2% of U.S. children between the ages of 3 and 17 have been diagnosed with depression, according to the Centers for Disease Control and Prevention. The American Academy of Pediatrics and the U.S. Preventive Services Task Force recommends that all teens be routinely screened for depression. However, there’s no specific recommendation that adolescents should also be screened for suicide in addition to depression screening.

The study highlights the high baseline rates of depression and suicide risk and the need for pediatric practices to plan for them and develop strategies about how they’re going to provide follow-up care, including treatment for suicidal teens.

“We began this project because we were concerned that we might be missing teens with increased risk of suicide by screening only for depression,” study author Alex Kemper, MD, said in an interview. “Our goal with this project was really to compare standard depression screening tools that we’ve used for a long time with a suicide-specific instrument just to see if we would identify additional cases with a suicide-risk instrument.”

Dr. Kemper and colleagues collected data from 803 mostly Medicaid-enrolled adolescents across 12 primary care practices. The subjects were between the ages of 12 and 20 years, with no recent history of depression or self-harm, who were screened with the Patient Health Questionnaire–9 Modified for Adolescents (PHQ-9A) and ASQ. For the study, two PHQ-9A screening strategies were evaluated: screening for any type of depression or other mental illness (positive on any item) or screening for major depressive disorder.

In addition, the researchers found that 56.4% of patients had a positive PHQ-9A screen for any type of depression and 24.7% had a positive PHQ-9A screen for major depressive disorder. Meanwhile, 21.1% of the population received a positive screen result. Of those who responded on the PHQ-9A that they did not have suicidal thoughts in the past month, 13.2% had a positive ASQ result.

Dr. Kemper, division chief of primary care pediatrics at Nationwide Children’s Hospital and professor of pediatrics at the Ohio State University, both in Columbus, said the suicide-risk screening questions were more direct and clear than were the two suicide questions included in the PHQ-9A screening.

For example, the PHQ-9A includes the following suicide-risk questions: “Has there been a time in the past month when you have had serious thoughts about ending your life?” and “Have you EVER, in your WHOLE LIFE, tried to kill yourself or made a suicide attempt?” The teen can respond with “not at all,” “several days,” “more than half the days” or “nearly every day.”

Meanwhile, the ASQ questionnaire focuses on a more narrow time period and includes questions such as “In the past few weeks, have you wished you were dead?” and “Have you ever tried to kill yourself?” Teens respond by answering “yes” or “no.”

“So I think the difference is by asking questions that are really direct and very clear about suicide risk, you end up identifying more cases than this kind of general question about thoughts of killing yourself,” Dr. Kemper explained. “It makes sense when you think about where adolescents are in terms of their development, that the more specific you [are], the more likely you are to find what you’re looking for.”

Kelly Curran, MD, who was not involved in the study, said that because some of the ASQ questions “overlap” with the suicide-risk questions on the PHQ-9A, she didn’t expect the ASQ to identify more positive cases.

However, Dr. Curran said it is possible for suicidal teens to fall through the cracks during a depression screening because some of them may not self-identify as depressed.

“I don’t think we often think about the importance of linguistics or how something is asked,” said Dr. Curran, associate professor in the department of pediatrics at the University of Oklahoma, Oklahoma City.

“So asking [teens] these kind of direct questions about suicide may pick up on these cases of people who don’t necessarily have the insight into their sadness or their general kind of thought process.”

Dr. Kemper said he hopes the study would encourage pediatricians to adopt depression screening if they’re not already doing it and to think about whether they should implement suicide-risk screening in their practice. The study also highlights the importance of following up after a positive screening.

“There are a lot of teens who have depression or increased suicide risk that you wouldn’t identify if you didn’t screen, and a key aspect of any kind of screening is that you need to be prepared to provide follow-up care after a positive screening,” he explained.

Study limitations include the fact that the subjects were recruited from a single health care system that serves mostly urban and low-income communities, and that the study was not designed to determine test accuracy.

Dr. Kemper and Dr. Curran indicated that they have no financial disclosures.
 

Suicide-risk screening may identify cases that typically fall through the cracks during depression screening, new research suggests.

The study, published in Pediatrics, found that the Ask Suicide-Screening Questions (ASQ) identified 2.2% of additional cases compared with those screened for any type of depression or other mental illnesses, and 8.3% of additional cases compared with those who screened positive for major depressive disorder.

About 3.2% of U.S. children between the ages of 3 and 17 have been diagnosed with depression, according to the Centers for Disease Control and Prevention. The American Academy of Pediatrics and the U.S. Preventive Services Task Force recommends that all teens be routinely screened for depression. However, there’s no specific recommendation that adolescents should also be screened for suicide in addition to depression screening.

The study highlights the high baseline rates of depression and suicide risk and the need for pediatric practices to plan for them and develop strategies about how they’re going to provide follow-up care, including treatment for suicidal teens.

“We began this project because we were concerned that we might be missing teens with increased risk of suicide by screening only for depression,” study author Alex Kemper, MD, said in an interview. “Our goal with this project was really to compare standard depression screening tools that we’ve used for a long time with a suicide-specific instrument just to see if we would identify additional cases with a suicide-risk instrument.”

Dr. Kemper and colleagues collected data from 803 mostly Medicaid-enrolled adolescents across 12 primary care practices. The subjects were between the ages of 12 and 20 years, with no recent history of depression or self-harm, who were screened with the Patient Health Questionnaire–9 Modified for Adolescents (PHQ-9A) and ASQ. For the study, two PHQ-9A screening strategies were evaluated: screening for any type of depression or other mental illness (positive on any item) or screening for major depressive disorder.

In addition, the researchers found that 56.4% of patients had a positive PHQ-9A screen for any type of depression and 24.7% had a positive PHQ-9A screen for major depressive disorder. Meanwhile, 21.1% of the population received a positive screen result. Of those who responded on the PHQ-9A that they did not have suicidal thoughts in the past month, 13.2% had a positive ASQ result.

Dr. Kemper, division chief of primary care pediatrics at Nationwide Children’s Hospital and professor of pediatrics at the Ohio State University, both in Columbus, said the suicide-risk screening questions were more direct and clear than were the two suicide questions included in the PHQ-9A screening.

For example, the PHQ-9A includes the following suicide-risk questions: “Has there been a time in the past month when you have had serious thoughts about ending your life?” and “Have you EVER, in your WHOLE LIFE, tried to kill yourself or made a suicide attempt?” The teen can respond with “not at all,” “several days,” “more than half the days” or “nearly every day.”

Meanwhile, the ASQ questionnaire focuses on a more narrow time period and includes questions such as “In the past few weeks, have you wished you were dead?” and “Have you ever tried to kill yourself?” Teens respond by answering “yes” or “no.”

“So I think the difference is by asking questions that are really direct and very clear about suicide risk, you end up identifying more cases than this kind of general question about thoughts of killing yourself,” Dr. Kemper explained. “It makes sense when you think about where adolescents are in terms of their development, that the more specific you [are], the more likely you are to find what you’re looking for.”

Kelly Curran, MD, who was not involved in the study, said that because some of the ASQ questions “overlap” with the suicide-risk questions on the PHQ-9A, she didn’t expect the ASQ to identify more positive cases.

However, Dr. Curran said it is possible for suicidal teens to fall through the cracks during a depression screening because some of them may not self-identify as depressed.

“I don’t think we often think about the importance of linguistics or how something is asked,” said Dr. Curran, associate professor in the department of pediatrics at the University of Oklahoma, Oklahoma City.

“So asking [teens] these kind of direct questions about suicide may pick up on these cases of people who don’t necessarily have the insight into their sadness or their general kind of thought process.”

Dr. Kemper said he hopes the study would encourage pediatricians to adopt depression screening if they’re not already doing it and to think about whether they should implement suicide-risk screening in their practice. The study also highlights the importance of following up after a positive screening.

“There are a lot of teens who have depression or increased suicide risk that you wouldn’t identify if you didn’t screen, and a key aspect of any kind of screening is that you need to be prepared to provide follow-up care after a positive screening,” he explained.

Study limitations include the fact that the subjects were recruited from a single health care system that serves mostly urban and low-income communities, and that the study was not designed to determine test accuracy.

Dr. Kemper and Dr. Curran indicated that they have no financial disclosures.
 

Suicide-risk screening may identify cases that typically fall through the cracks during depression screening, new research suggests.

The study, published in Pediatrics, found that the Ask Suicide-Screening Questions (ASQ) identified 2.2% of additional cases compared with those screened for any type of depression or other mental illnesses, and 8.3% of additional cases compared with those who screened positive for major depressive disorder.

About 3.2% of U.S. children between the ages of 3 and 17 have been diagnosed with depression, according to the Centers for Disease Control and Prevention. The American Academy of Pediatrics and the U.S. Preventive Services Task Force recommends that all teens be routinely screened for depression. However, there’s no specific recommendation that adolescents should also be screened for suicide in addition to depression screening.

The study highlights the high baseline rates of depression and suicide risk and the need for pediatric practices to plan for them and develop strategies about how they’re going to provide follow-up care, including treatment for suicidal teens.

“We began this project because we were concerned that we might be missing teens with increased risk of suicide by screening only for depression,” study author Alex Kemper, MD, said in an interview. “Our goal with this project was really to compare standard depression screening tools that we’ve used for a long time with a suicide-specific instrument just to see if we would identify additional cases with a suicide-risk instrument.”

Dr. Kemper and colleagues collected data from 803 mostly Medicaid-enrolled adolescents across 12 primary care practices. The subjects were between the ages of 12 and 20 years, with no recent history of depression or self-harm, who were screened with the Patient Health Questionnaire–9 Modified for Adolescents (PHQ-9A) and ASQ. For the study, two PHQ-9A screening strategies were evaluated: screening for any type of depression or other mental illness (positive on any item) or screening for major depressive disorder.

In addition, the researchers found that 56.4% of patients had a positive PHQ-9A screen for any type of depression and 24.7% had a positive PHQ-9A screen for major depressive disorder. Meanwhile, 21.1% of the population received a positive screen result. Of those who responded on the PHQ-9A that they did not have suicidal thoughts in the past month, 13.2% had a positive ASQ result.

Dr. Kemper, division chief of primary care pediatrics at Nationwide Children’s Hospital and professor of pediatrics at the Ohio State University, both in Columbus, said the suicide-risk screening questions were more direct and clear than were the two suicide questions included in the PHQ-9A screening.

For example, the PHQ-9A includes the following suicide-risk questions: “Has there been a time in the past month when you have had serious thoughts about ending your life?” and “Have you EVER, in your WHOLE LIFE, tried to kill yourself or made a suicide attempt?” The teen can respond with “not at all,” “several days,” “more than half the days” or “nearly every day.”

Meanwhile, the ASQ questionnaire focuses on a more narrow time period and includes questions such as “In the past few weeks, have you wished you were dead?” and “Have you ever tried to kill yourself?” Teens respond by answering “yes” or “no.”

“So I think the difference is by asking questions that are really direct and very clear about suicide risk, you end up identifying more cases than this kind of general question about thoughts of killing yourself,” Dr. Kemper explained. “It makes sense when you think about where adolescents are in terms of their development, that the more specific you [are], the more likely you are to find what you’re looking for.”

Kelly Curran, MD, who was not involved in the study, said that because some of the ASQ questions “overlap” with the suicide-risk questions on the PHQ-9A, she didn’t expect the ASQ to identify more positive cases.

However, Dr. Curran said it is possible for suicidal teens to fall through the cracks during a depression screening because some of them may not self-identify as depressed.

“I don’t think we often think about the importance of linguistics or how something is asked,” said Dr. Curran, associate professor in the department of pediatrics at the University of Oklahoma, Oklahoma City.

“So asking [teens] these kind of direct questions about suicide may pick up on these cases of people who don’t necessarily have the insight into their sadness or their general kind of thought process.”

Dr. Kemper said he hopes the study would encourage pediatricians to adopt depression screening if they’re not already doing it and to think about whether they should implement suicide-risk screening in their practice. The study also highlights the importance of following up after a positive screening.

“There are a lot of teens who have depression or increased suicide risk that you wouldn’t identify if you didn’t screen, and a key aspect of any kind of screening is that you need to be prepared to provide follow-up care after a positive screening,” he explained.

Study limitations include the fact that the subjects were recruited from a single health care system that serves mostly urban and low-income communities, and that the study was not designed to determine test accuracy.

Dr. Kemper and Dr. Curran indicated that they have no financial disclosures.
 

Obesity, atopic dermatitis, psychiatric disease, and arthritis are the most common comorbidities among infants, children, and adolescents with psoriasis, while predictors of moderate to severe disease include morphology, non-White race, and culture-confirmed infection.

Those are among the key findings from a retrospective analysis of pediatric psoriasis patients who were seen at the University of California, San Francisco, over a 24-year period.

“Overall, our data support prior findings of age- and sex-based differences in location and morphology and presents new information demonstrating associations with severity,” presenting study author Carmel Aghdasi said during the annual meeting of the Society for Pediatric Dermatology. “We provide evidence of the increased use of systemic and biologic therapies over time, an important step in ensuring pediatric patients are adequately treated.”

To characterize the demographics, clinical features, comorbidities, and treatments, and to determine predictors of severity and changes in treatment patterns over 2 decades in a large cohort of pediatric psoriasis patients, Ms. Aghdasi, a 4th-year medical student at the University of California, San Francisco, and colleagues retrospectively evaluated the records of 754 pediatric patients up to 18 years of age who were seen at UCSF for psoriasis from 1997 to 2021. They collected demographic, clinical, familial, comorbidity, and treatment data and divided the cohort into two groups by date of last visit.

Group 1 consisted of 332 patients whose last visit was between 2001 and 2011, while the second group included 422 patients whose last visit was between 2012 and 2021. The researchers also divided the cohort into three age groups: infants (0-2 years of age), children (3-12 years of age), and adolescents (13-18 years of age).

Slightly more than half of the patients (55%) were female and 67% presented between ages 3 and 12. (Seventy-four patients were in the youngest category, 0-2 years, when they presented.) The average age of disease onset was 7 years, the average age at presentation to pediatric dermatology was 8.8 years, and 37% of the total cohort were overweight or obese. The top four comorbidities were being overweight or obese (37%), followed by atopic dermatitis (19%), psychiatric disease (7%), and arthritis (4%).

Plaque was the most common morphology (56%), while the most common sites of involvement were the head and neck (69%), extremities (61%), and trunk (44%). About half of the cohort (51%) had mild disease, 15% had culture-confirmed infections (9% had Streptococcal infections), and 66% of patients reported itch as a symptom.

The researchers observed that inverse psoriasis was significantly more common in infants and decreased with age. Anogenital involvement was more common in males and in those aged 0-2, while head and neck involvement was more common in females. Nail involvement was more common in childhood.

Topical therapy was the most common treatment overall and by far the most common among those in the 0-2 age category. “Overall, phototherapy was used in childhood and adolescents but almost never in infancy,” Ms. Aghdasi said. “Looking at changes in systemic treatment over time, conventional systemic use increased in infants and children and decreased in adolescents. Biologic use increased in all ages, most notably in children aged 3-12 years old.”

Multivariate regression analyses revealed that the following independent variables predicted moderate to severe psoriasis: adolescent age (adjusted odds ratio, 1.9; P = .03), guttate morphology (aOR, 2.2; P = .006), plaque and guttate morphology (aOR, 7.6; P less than .001), pustular or erythrodermic morphology (aOR, 5; P = .003), culture-confirmed infection (aOR, 2; P = .007), Black race (aOR, 3.3; P = .007), Asian race (aOR, 1.8; P = .04, and Hispanic race (aOR, 1.9; P = .03).

“Further analysis is needed to elucidate the influence of race on severity and of the clinical utility of infection as a marker of severity,” Ms. Aghdasi said. “Interestingly, we did not find that obesity was a marker of severity in our cohort.”

In an interview, senior study author Kelly M. Cordoro, MD, professor of dermatology and pediatrics at UCSF, noted that this finding conflicts with prior studies showing an association between obesity and severe psoriasis in children.

[email protected]

Obesity, atopic dermatitis, psychiatric disease, and arthritis are the most common comorbidities among infants, children, and adolescents with psoriasis, while predictors of moderate to severe disease include morphology, non-White race, and culture-confirmed infection.

Those are among the key findings from a retrospective analysis of pediatric psoriasis patients who were seen at the University of California, San Francisco, over a 24-year period.

“Overall, our data support prior findings of age- and sex-based differences in location and morphology and presents new information demonstrating associations with severity,” presenting study author Carmel Aghdasi said during the annual meeting of the Society for Pediatric Dermatology. “We provide evidence of the increased use of systemic and biologic therapies over time, an important step in ensuring pediatric patients are adequately treated.”

To characterize the demographics, clinical features, comorbidities, and treatments, and to determine predictors of severity and changes in treatment patterns over 2 decades in a large cohort of pediatric psoriasis patients, Ms. Aghdasi, a 4th-year medical student at the University of California, San Francisco, and colleagues retrospectively evaluated the records of 754 pediatric patients up to 18 years of age who were seen at UCSF for psoriasis from 1997 to 2021. They collected demographic, clinical, familial, comorbidity, and treatment data and divided the cohort into two groups by date of last visit.

Group 1 consisted of 332 patients whose last visit was between 2001 and 2011, while the second group included 422 patients whose last visit was between 2012 and 2021. The researchers also divided the cohort into three age groups: infants (0-2 years of age), children (3-12 years of age), and adolescents (13-18 years of age).

Slightly more than half of the patients (55%) were female and 67% presented between ages 3 and 12. (Seventy-four patients were in the youngest category, 0-2 years, when they presented.) The average age of disease onset was 7 years, the average age at presentation to pediatric dermatology was 8.8 years, and 37% of the total cohort were overweight or obese. The top four comorbidities were being overweight or obese (37%), followed by atopic dermatitis (19%), psychiatric disease (7%), and arthritis (4%).

Plaque was the most common morphology (56%), while the most common sites of involvement were the head and neck (69%), extremities (61%), and trunk (44%). About half of the cohort (51%) had mild disease, 15% had culture-confirmed infections (9% had Streptococcal infections), and 66% of patients reported itch as a symptom.

The researchers observed that inverse psoriasis was significantly more common in infants and decreased with age. Anogenital involvement was more common in males and in those aged 0-2, while head and neck involvement was more common in females. Nail involvement was more common in childhood.

Topical therapy was the most common treatment overall and by far the most common among those in the 0-2 age category. “Overall, phototherapy was used in childhood and adolescents but almost never in infancy,” Ms. Aghdasi said. “Looking at changes in systemic treatment over time, conventional systemic use increased in infants and children and decreased in adolescents. Biologic use increased in all ages, most notably in children aged 3-12 years old.”

Multivariate regression analyses revealed that the following independent variables predicted moderate to severe psoriasis: adolescent age (adjusted odds ratio, 1.9; P = .03), guttate morphology (aOR, 2.2; P = .006), plaque and guttate morphology (aOR, 7.6; P less than .001), pustular or erythrodermic morphology (aOR, 5; P = .003), culture-confirmed infection (aOR, 2; P = .007), Black race (aOR, 3.3; P = .007), Asian race (aOR, 1.8; P = .04, and Hispanic race (aOR, 1.9; P = .03).

“Further analysis is needed to elucidate the influence of race on severity and of the clinical utility of infection as a marker of severity,” Ms. Aghdasi said. “Interestingly, we did not find that obesity was a marker of severity in our cohort.”

In an interview, senior study author Kelly M. Cordoro, MD, professor of dermatology and pediatrics at UCSF, noted that this finding conflicts with prior studies showing an association between obesity and severe psoriasis in children.

[email protected]

Obesity, atopic dermatitis, psychiatric disease, and arthritis are the most common comorbidities among infants, children, and adolescents with psoriasis, while predictors of moderate to severe disease include morphology, non-White race, and culture-confirmed infection.

Those are among the key findings from a retrospective analysis of pediatric psoriasis patients who were seen at the University of California, San Francisco, over a 24-year period.

“Overall, our data support prior findings of age- and sex-based differences in location and morphology and presents new information demonstrating associations with severity,” presenting study author Carmel Aghdasi said during the annual meeting of the Society for Pediatric Dermatology. “We provide evidence of the increased use of systemic and biologic therapies over time, an important step in ensuring pediatric patients are adequately treated.”

To characterize the demographics, clinical features, comorbidities, and treatments, and to determine predictors of severity and changes in treatment patterns over 2 decades in a large cohort of pediatric psoriasis patients, Ms. Aghdasi, a 4th-year medical student at the University of California, San Francisco, and colleagues retrospectively evaluated the records of 754 pediatric patients up to 18 years of age who were seen at UCSF for psoriasis from 1997 to 2021. They collected demographic, clinical, familial, comorbidity, and treatment data and divided the cohort into two groups by date of last visit.

Group 1 consisted of 332 patients whose last visit was between 2001 and 2011, while the second group included 422 patients whose last visit was between 2012 and 2021. The researchers also divided the cohort into three age groups: infants (0-2 years of age), children (3-12 years of age), and adolescents (13-18 years of age).

Slightly more than half of the patients (55%) were female and 67% presented between ages 3 and 12. (Seventy-four patients were in the youngest category, 0-2 years, when they presented.) The average age of disease onset was 7 years, the average age at presentation to pediatric dermatology was 8.8 years, and 37% of the total cohort were overweight or obese. The top four comorbidities were being overweight or obese (37%), followed by atopic dermatitis (19%), psychiatric disease (7%), and arthritis (4%).

Plaque was the most common morphology (56%), while the most common sites of involvement were the head and neck (69%), extremities (61%), and trunk (44%). About half of the cohort (51%) had mild disease, 15% had culture-confirmed infections (9% had Streptococcal infections), and 66% of patients reported itch as a symptom.

The researchers observed that inverse psoriasis was significantly more common in infants and decreased with age. Anogenital involvement was more common in males and in those aged 0-2, while head and neck involvement was more common in females. Nail involvement was more common in childhood.

Topical therapy was the most common treatment overall and by far the most common among those in the 0-2 age category. “Overall, phototherapy was used in childhood and adolescents but almost never in infancy,” Ms. Aghdasi said. “Looking at changes in systemic treatment over time, conventional systemic use increased in infants and children and decreased in adolescents. Biologic use increased in all ages, most notably in children aged 3-12 years old.”

Multivariate regression analyses revealed that the following independent variables predicted moderate to severe psoriasis: adolescent age (adjusted odds ratio, 1.9; P = .03), guttate morphology (aOR, 2.2; P = .006), plaque and guttate morphology (aOR, 7.6; P less than .001), pustular or erythrodermic morphology (aOR, 5; P = .003), culture-confirmed infection (aOR, 2; P = .007), Black race (aOR, 3.3; P = .007), Asian race (aOR, 1.8; P = .04, and Hispanic race (aOR, 1.9; P = .03).

“Further analysis is needed to elucidate the influence of race on severity and of the clinical utility of infection as a marker of severity,” Ms. Aghdasi said. “Interestingly, we did not find that obesity was a marker of severity in our cohort.”

In an interview, senior study author Kelly M. Cordoro, MD, professor of dermatology and pediatrics at UCSF, noted that this finding conflicts with prior studies showing an association between obesity and severe psoriasis in children.

[email protected]

Children conceived with assisted reproductive techniques (ART) do not appear to be more likely to have attention-deficit/hyperactivity disorder or poor school performance, compared with children conceived spontaneously, according to a study published in Pediatrics.

The findings, based on an analysis of data from more than 1.5 million children in Sweden, provide “additional reassurance concerning offspring neurodevelopment after use of ART,” study author Chen Wang, MPH, and colleagues said. The results show the importance of accounting for underlying infertility when studying ART safety, they added. Mr. Wang is a researcher in the department of medical epidemiology and biostatistics at Karolinska Institutet in Stockholm.

Prior research has not shown major differences during early childhood between children conceived with ART and those conceived spontaneously. To examine long-term neurodevelopmental outcomes, including ADHD and school performance, the investigators analyzed data in Swedish population registers from children born between 1986 and 2012.

Infertility and the use of ART became increasingly common during the study period, the researchers noted. Between 1986 and 2001, 7% of births were to couples with known infertility, and 13% of these births were achieved with ART. Between 1996 and 2012, 11% of births were to couples with infertility, and 26% of these births were achieved with ART.

“Couples with infertility were more likely older and married or cohabiting, compared with couples with no known infertility,” Mr. Wang and colleagues reported. “Among infertile couples, those that conceived with ART had, on average, higher age and education, and the women were less likely to smoke.”

The investigators estimated that the cumulative incidence of ADHD by age 15 years was 6.2% in children conceived with ART, 7.3% among children of couples with infertility who did not use ART, and 7.1% in children born to couples with no known infertility.

Overall, children conceived with ART were at lower risk of ADHD (hazard ratio, 0.83). But after adjusting for parental characteristics and health factors, the researchers found a “slightly elevated risk of ADHD with ART,” with adjusted HRs of 1.05-1.07.

When the researchers focused on children born to couples with infertility, ART was associated with a lower risk of ADHD (adjusted HR, 0.80), compared with spontaneous conception. Accounting for parental characteristics and health history, however, “attenuated the association toward the null,” the researchers reported.

The researchers also compared ART methods, including intracytoplasmic sperm injection versus standard in vitro fertilization (IVF), and fresh embryo transfer versus frozen embryo transfer. The various procedures were not associated with substantially different risks.

Patterns for school performance were generally similar to those for ADHD.

“In this large follow-up of nationwide birth cohorts, we observed lower risk of ADHD and slightly better overall school performance in children conceived with ART, compared with all other children. Differences in parental characteristics appeared to completely explain and even slightly reverse the associations,” the study authors said. “When the comparison was restricted to children of couples with known infertility, no differences were seen.”

The study was well designed and “spans more than 25 years of ART during which treatments have changed dramatically,” commented Barbara Luke, ScD, MPH, professor of obstetrics, gynecology, and reproductive biology at Michigan State University, East Lansing.

Dr. Luke and colleagues have studied academic achievement in children conceived with IVF in Texas. The results of the Swedish study “are in line with U.S. studies, and are generally reassuring,” Dr. Luke said.

The U.S. studies also showed that parental factors may play a role in understanding academic performance.

“In our studies of third-grade and sixth-grade academic outcomes, we found differences by racial/Hispanic origin groups, gender, and maternal age,” she said.

The study by Mr. Wang and coauthors was funded by grants from a Swedish government agency and the National Institutes of Health. The researchers and Dr. Luke had no relevant financial disclosures.

[email protected]

Children conceived with assisted reproductive techniques (ART) do not appear to be more likely to have attention-deficit/hyperactivity disorder or poor school performance, compared with children conceived spontaneously, according to a study published in Pediatrics.

The findings, based on an analysis of data from more than 1.5 million children in Sweden, provide “additional reassurance concerning offspring neurodevelopment after use of ART,” study author Chen Wang, MPH, and colleagues said. The results show the importance of accounting for underlying infertility when studying ART safety, they added. Mr. Wang is a researcher in the department of medical epidemiology and biostatistics at Karolinska Institutet in Stockholm.

Prior research has not shown major differences during early childhood between children conceived with ART and those conceived spontaneously. To examine long-term neurodevelopmental outcomes, including ADHD and school performance, the investigators analyzed data in Swedish population registers from children born between 1986 and 2012.

Infertility and the use of ART became increasingly common during the study period, the researchers noted. Between 1986 and 2001, 7% of births were to couples with known infertility, and 13% of these births were achieved with ART. Between 1996 and 2012, 11% of births were to couples with infertility, and 26% of these births were achieved with ART.

“Couples with infertility were more likely older and married or cohabiting, compared with couples with no known infertility,” Mr. Wang and colleagues reported. “Among infertile couples, those that conceived with ART had, on average, higher age and education, and the women were less likely to smoke.”

The investigators estimated that the cumulative incidence of ADHD by age 15 years was 6.2% in children conceived with ART, 7.3% among children of couples with infertility who did not use ART, and 7.1% in children born to couples with no known infertility.

Overall, children conceived with ART were at lower risk of ADHD (hazard ratio, 0.83). But after adjusting for parental characteristics and health factors, the researchers found a “slightly elevated risk of ADHD with ART,” with adjusted HRs of 1.05-1.07.

When the researchers focused on children born to couples with infertility, ART was associated with a lower risk of ADHD (adjusted HR, 0.80), compared with spontaneous conception. Accounting for parental characteristics and health history, however, “attenuated the association toward the null,” the researchers reported.

The researchers also compared ART methods, including intracytoplasmic sperm injection versus standard in vitro fertilization (IVF), and fresh embryo transfer versus frozen embryo transfer. The various procedures were not associated with substantially different risks.

Patterns for school performance were generally similar to those for ADHD.

“In this large follow-up of nationwide birth cohorts, we observed lower risk of ADHD and slightly better overall school performance in children conceived with ART, compared with all other children. Differences in parental characteristics appeared to completely explain and even slightly reverse the associations,” the study authors said. “When the comparison was restricted to children of couples with known infertility, no differences were seen.”

The study was well designed and “spans more than 25 years of ART during which treatments have changed dramatically,” commented Barbara Luke, ScD, MPH, professor of obstetrics, gynecology, and reproductive biology at Michigan State University, East Lansing.

Dr. Luke and colleagues have studied academic achievement in children conceived with IVF in Texas. The results of the Swedish study “are in line with U.S. studies, and are generally reassuring,” Dr. Luke said.

The U.S. studies also showed that parental factors may play a role in understanding academic performance.

“In our studies of third-grade and sixth-grade academic outcomes, we found differences by racial/Hispanic origin groups, gender, and maternal age,” she said.

The study by Mr. Wang and coauthors was funded by grants from a Swedish government agency and the National Institutes of Health. The researchers and Dr. Luke had no relevant financial disclosures.

[email protected]

Children conceived with assisted reproductive techniques (ART) do not appear to be more likely to have attention-deficit/hyperactivity disorder or poor school performance, compared with children conceived spontaneously, according to a study published in Pediatrics.

The findings, based on an analysis of data from more than 1.5 million children in Sweden, provide “additional reassurance concerning offspring neurodevelopment after use of ART,” study author Chen Wang, MPH, and colleagues said. The results show the importance of accounting for underlying infertility when studying ART safety, they added. Mr. Wang is a researcher in the department of medical epidemiology and biostatistics at Karolinska Institutet in Stockholm.

Prior research has not shown major differences during early childhood between children conceived with ART and those conceived spontaneously. To examine long-term neurodevelopmental outcomes, including ADHD and school performance, the investigators analyzed data in Swedish population registers from children born between 1986 and 2012.

Infertility and the use of ART became increasingly common during the study period, the researchers noted. Between 1986 and 2001, 7% of births were to couples with known infertility, and 13% of these births were achieved with ART. Between 1996 and 2012, 11% of births were to couples with infertility, and 26% of these births were achieved with ART.

“Couples with infertility were more likely older and married or cohabiting, compared with couples with no known infertility,” Mr. Wang and colleagues reported. “Among infertile couples, those that conceived with ART had, on average, higher age and education, and the women were less likely to smoke.”

The investigators estimated that the cumulative incidence of ADHD by age 15 years was 6.2% in children conceived with ART, 7.3% among children of couples with infertility who did not use ART, and 7.1% in children born to couples with no known infertility.

Overall, children conceived with ART were at lower risk of ADHD (hazard ratio, 0.83). But after adjusting for parental characteristics and health factors, the researchers found a “slightly elevated risk of ADHD with ART,” with adjusted HRs of 1.05-1.07.

When the researchers focused on children born to couples with infertility, ART was associated with a lower risk of ADHD (adjusted HR, 0.80), compared with spontaneous conception. Accounting for parental characteristics and health history, however, “attenuated the association toward the null,” the researchers reported.

The researchers also compared ART methods, including intracytoplasmic sperm injection versus standard in vitro fertilization (IVF), and fresh embryo transfer versus frozen embryo transfer. The various procedures were not associated with substantially different risks.

Patterns for school performance were generally similar to those for ADHD.

“In this large follow-up of nationwide birth cohorts, we observed lower risk of ADHD and slightly better overall school performance in children conceived with ART, compared with all other children. Differences in parental characteristics appeared to completely explain and even slightly reverse the associations,” the study authors said. “When the comparison was restricted to children of couples with known infertility, no differences were seen.”

The study was well designed and “spans more than 25 years of ART during which treatments have changed dramatically,” commented Barbara Luke, ScD, MPH, professor of obstetrics, gynecology, and reproductive biology at Michigan State University, East Lansing.

Dr. Luke and colleagues have studied academic achievement in children conceived with IVF in Texas. The results of the Swedish study “are in line with U.S. studies, and are generally reassuring,” Dr. Luke said.

The U.S. studies also showed that parental factors may play a role in understanding academic performance.

“In our studies of third-grade and sixth-grade academic outcomes, we found differences by racial/Hispanic origin groups, gender, and maternal age,” she said.

The study by Mr. Wang and coauthors was funded by grants from a Swedish government agency and the National Institutes of Health. The researchers and Dr. Luke had no relevant financial disclosures.

[email protected]

All over the country, high numbers of youth experiencing a mental health crisis are presenting to emergency departments, where they are assessed to need an inpatient psychiatric hospitalization but then wait for days and sometimes weeks with nowhere to go. In Colorado, one of the largest children’s hospitals in the state declared their own state of emergency to call attention to the problem after facing a 72% increase in volume for mental health emergency visits.¹ This problem is hardly new, but the COVID pandemic has appeared to take the problem to new heights. In Massachusetts, the “boarding” of youth awaiting psychiatric hospitalization has more than doubled since the pandemic, according to a recent report from National Public Radio.² Like many public health problems, there is evidence that the burden falls disproportionately on groups that have faced health inequities in the past.³

What is causing this? The proximal cause is fairly simple: Acute mental health problems in youth are rising while the supply of intensive services is dropping. The number of available inpatient psychiatric beds has steadily been falling over the years even prior to the COVID pandemic, which then took more capacity offline because of staffing shortages and requirements for additional distance between patients (such as eliminating double-occupancy rooms). Meanwhile, levels of anxiety, depression, and suicidality have been rising in youth for reasons still not adequately understood.

The stories of these youth and their families waiting for stabilization and treatment are heartbreaking, and nobody disagrees with the idea that a child being confined to a small ED room for days is not good care. What is debated, however, is how best to fix this problem both in the short and long term. In the eyes of many, the ultimate solution is clear: more inpatient beds. This may indeed be required for some areas, but a closer look at how an entire mental health system operates often reveals both more complex problems and some alternative potential solutions. For example, hospital staff will often acknowledge that they have patients ready for discharge but who need more intensive step-down services like a residential treatment or partial hospital program to be able to do so safely. You can’t have hospital admissions if you don’t have hospital discharges, so without good step-down options patients back up and the regular flow is disrupted. Upstream of the crisis that sends many youth to EDs is another opportunity area, as these tipping points are often seen coming by others, including their pediatricians, but referrals to clinicians or programs that might bring improvement and prevent the need for an ED evaluation are also in short supply.

In the short term, efforts are being directed by some EDs to make the physical space more therapeutic for individuals experiencing mental health problems and to offer more actual treatment when people are there. This can take the form of having a secure space in which to move around, or being offered some supportive psychotherapy sessions and possible medication changes while in the ED. It can also involve simple things like the availability of books, video games, and toys to help pass the time. Such efforts are greatly needed, and many feel that the notion of mental health emergencies somehow being outside the “lane” of emergency medicine training and practice should have been retired long ago.

Medium-term solutions can involve the standing up of more intensive mental health programs that are below the level of inpatient hospitalizations, such as intensive outpatient or partial hospitalization programs, or improved mobile response services that go beyond triage and actually bring supports and techniques directly to families in need. As mentioned, these levels of services can provide both a step-down option that facilitates a hospital discharge and a measure that can prevent the need for some hospitalizations in the first place.

Looking over the long term, health care systems and governments need to evaluate the degree to which more hospital or residential beds may still be needed, despite our best efforts to improve flow and prevent mental health crises from originating. This can often be a contentious topic, however, and securing public dollars to support more beds is often quite difficult even where there seems to be a clear need.

Hovering over nearly all potential solutions, of course, is the challenge of finding the mental health workforce to implement any new programs and initiatives without stealing from services already in place. This dilemma speaks to ongoing issues of parity between resources devoted to mental health versus physical health care. Some mental health care organizations are currently trying to recruit new workers with bonuses or new incentives, but longer-term fixes are likely to require a hard look at the degree to which our actual commitment to mental health care matches the political rhetoric.

Discussions of how to solve the problem of ED boarding can easily deteriorate into a lot of finger pointing of what somebody else should be doing. The truth is, however, that there are many actions that can be taken by those in very different roles.

While many of these steps require efforts from mental health organizations, emergency departments, government agencies, and hospitals, there are things that can be done within the purview of the primary care clinician. First, look for opportunities to increase your collaboration with mental health professionals through initiatives such as integrated care programs. The Health Resources and Services Administration is now using funds from the American Rescue Plan Act to strengthen integrated care programs across the country and new opportunities may well be available soon to get additional mental health supports to primary care offices. Second, get involved and advocate for the mental health of your patients by communicating with other groups to make other potential solutions a reality.

Children and adolescents waiting for days to get the mental health care they need and deserve is an unacceptable situation that we can and must overcome. Quick fixes will be hard to find, but with some collaborative effort, forward thinking, and, yes, financial investments, we can find solutions that reflect the principle of mental health being a foundation for all health.

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @PediPsych. His latest book is “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood.”

References

1. Tabachnik S. Colorado health leaders declare youth mental health state of emergency: “Our kids have run out of resilience.” Denver Post. 2021 May 25. 

2. Bebinger M. Kids in mental health crisis can languish for days inside ERs. National Public Radio. 2021 Jun 23.

3. Nash KA et al. Pediatrics. 2021:147:5. e2020030692.

All over the country, high numbers of youth experiencing a mental health crisis are presenting to emergency departments, where they are assessed to need an inpatient psychiatric hospitalization but then wait for days and sometimes weeks with nowhere to go. In Colorado, one of the largest children’s hospitals in the state declared their own state of emergency to call attention to the problem after facing a 72% increase in volume for mental health emergency visits.¹ This problem is hardly new, but the COVID pandemic has appeared to take the problem to new heights. In Massachusetts, the “boarding” of youth awaiting psychiatric hospitalization has more than doubled since the pandemic, according to a recent report from National Public Radio.² Like many public health problems, there is evidence that the burden falls disproportionately on groups that have faced health inequities in the past.³

What is causing this? The proximal cause is fairly simple: Acute mental health problems in youth are rising while the supply of intensive services is dropping. The number of available inpatient psychiatric beds has steadily been falling over the years even prior to the COVID pandemic, which then took more capacity offline because of staffing shortages and requirements for additional distance between patients (such as eliminating double-occupancy rooms). Meanwhile, levels of anxiety, depression, and suicidality have been rising in youth for reasons still not adequately understood.

The stories of these youth and their families waiting for stabilization and treatment are heartbreaking, and nobody disagrees with the idea that a child being confined to a small ED room for days is not good care. What is debated, however, is how best to fix this problem both in the short and long term. In the eyes of many, the ultimate solution is clear: more inpatient beds. This may indeed be required for some areas, but a closer look at how an entire mental health system operates often reveals both more complex problems and some alternative potential solutions. For example, hospital staff will often acknowledge that they have patients ready for discharge but who need more intensive step-down services like a residential treatment or partial hospital program to be able to do so safely. You can’t have hospital admissions if you don’t have hospital discharges, so without good step-down options patients back up and the regular flow is disrupted. Upstream of the crisis that sends many youth to EDs is another opportunity area, as these tipping points are often seen coming by others, including their pediatricians, but referrals to clinicians or programs that might bring improvement and prevent the need for an ED evaluation are also in short supply.

In the short term, efforts are being directed by some EDs to make the physical space more therapeutic for individuals experiencing mental health problems and to offer more actual treatment when people are there. This can take the form of having a secure space in which to move around, or being offered some supportive psychotherapy sessions and possible medication changes while in the ED. It can also involve simple things like the availability of books, video games, and toys to help pass the time. Such efforts are greatly needed, and many feel that the notion of mental health emergencies somehow being outside the “lane” of emergency medicine training and practice should have been retired long ago.

Medium-term solutions can involve the standing up of more intensive mental health programs that are below the level of inpatient hospitalizations, such as intensive outpatient or partial hospitalization programs, or improved mobile response services that go beyond triage and actually bring supports and techniques directly to families in need. As mentioned, these levels of services can provide both a step-down option that facilitates a hospital discharge and a measure that can prevent the need for some hospitalizations in the first place.

Looking over the long term, health care systems and governments need to evaluate the degree to which more hospital or residential beds may still be needed, despite our best efforts to improve flow and prevent mental health crises from originating. This can often be a contentious topic, however, and securing public dollars to support more beds is often quite difficult even where there seems to be a clear need.

Hovering over nearly all potential solutions, of course, is the challenge of finding the mental health workforce to implement any new programs and initiatives without stealing from services already in place. This dilemma speaks to ongoing issues of parity between resources devoted to mental health versus physical health care. Some mental health care organizations are currently trying to recruit new workers with bonuses or new incentives, but longer-term fixes are likely to require a hard look at the degree to which our actual commitment to mental health care matches the political rhetoric.

Discussions of how to solve the problem of ED boarding can easily deteriorate into a lot of finger pointing of what somebody else should be doing. The truth is, however, that there are many actions that can be taken by those in very different roles.

While many of these steps require efforts from mental health organizations, emergency departments, government agencies, and hospitals, there are things that can be done within the purview of the primary care clinician. First, look for opportunities to increase your collaboration with mental health professionals through initiatives such as integrated care programs. The Health Resources and Services Administration is now using funds from the American Rescue Plan Act to strengthen integrated care programs across the country and new opportunities may well be available soon to get additional mental health supports to primary care offices. Second, get involved and advocate for the mental health of your patients by communicating with other groups to make other potential solutions a reality.

Children and adolescents waiting for days to get the mental health care they need and deserve is an unacceptable situation that we can and must overcome. Quick fixes will be hard to find, but with some collaborative effort, forward thinking, and, yes, financial investments, we can find solutions that reflect the principle of mental health being a foundation for all health.

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @PediPsych. His latest book is “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood.”

References

1. Tabachnik S. Colorado health leaders declare youth mental health state of emergency: “Our kids have run out of resilience.” Denver Post. 2021 May 25. 

2. Bebinger M. Kids in mental health crisis can languish for days inside ERs. National Public Radio. 2021 Jun 23.

3. Nash KA et al. Pediatrics. 2021:147:5. e2020030692.

All over the country, high numbers of youth experiencing a mental health crisis are presenting to emergency departments, where they are assessed to need an inpatient psychiatric hospitalization but then wait for days and sometimes weeks with nowhere to go. In Colorado, one of the largest children’s hospitals in the state declared their own state of emergency to call attention to the problem after facing a 72% increase in volume for mental health emergency visits.¹ This problem is hardly new, but the COVID pandemic has appeared to take the problem to new heights. In Massachusetts, the “boarding” of youth awaiting psychiatric hospitalization has more than doubled since the pandemic, according to a recent report from National Public Radio.² Like many public health problems, there is evidence that the burden falls disproportionately on groups that have faced health inequities in the past.³

What is causing this? The proximal cause is fairly simple: Acute mental health problems in youth are rising while the supply of intensive services is dropping. The number of available inpatient psychiatric beds has steadily been falling over the years even prior to the COVID pandemic, which then took more capacity offline because of staffing shortages and requirements for additional distance between patients (such as eliminating double-occupancy rooms). Meanwhile, levels of anxiety, depression, and suicidality have been rising in youth for reasons still not adequately understood.

The stories of these youth and their families waiting for stabilization and treatment are heartbreaking, and nobody disagrees with the idea that a child being confined to a small ED room for days is not good care. What is debated, however, is how best to fix this problem both in the short and long term. In the eyes of many, the ultimate solution is clear: more inpatient beds. This may indeed be required for some areas, but a closer look at how an entire mental health system operates often reveals both more complex problems and some alternative potential solutions. For example, hospital staff will often acknowledge that they have patients ready for discharge but who need more intensive step-down services like a residential treatment or partial hospital program to be able to do so safely. You can’t have hospital admissions if you don’t have hospital discharges, so without good step-down options patients back up and the regular flow is disrupted. Upstream of the crisis that sends many youth to EDs is another opportunity area, as these tipping points are often seen coming by others, including their pediatricians, but referrals to clinicians or programs that might bring improvement and prevent the need for an ED evaluation are also in short supply.

In the short term, efforts are being directed by some EDs to make the physical space more therapeutic for individuals experiencing mental health problems and to offer more actual treatment when people are there. This can take the form of having a secure space in which to move around, or being offered some supportive psychotherapy sessions and possible medication changes while in the ED. It can also involve simple things like the availability of books, video games, and toys to help pass the time. Such efforts are greatly needed, and many feel that the notion of mental health emergencies somehow being outside the “lane” of emergency medicine training and practice should have been retired long ago.

Medium-term solutions can involve the standing up of more intensive mental health programs that are below the level of inpatient hospitalizations, such as intensive outpatient or partial hospitalization programs, or improved mobile response services that go beyond triage and actually bring supports and techniques directly to families in need. As mentioned, these levels of services can provide both a step-down option that facilitates a hospital discharge and a measure that can prevent the need for some hospitalizations in the first place.

Looking over the long term, health care systems and governments need to evaluate the degree to which more hospital or residential beds may still be needed, despite our best efforts to improve flow and prevent mental health crises from originating. This can often be a contentious topic, however, and securing public dollars to support more beds is often quite difficult even where there seems to be a clear need.

Hovering over nearly all potential solutions, of course, is the challenge of finding the mental health workforce to implement any new programs and initiatives without stealing from services already in place. This dilemma speaks to ongoing issues of parity between resources devoted to mental health versus physical health care. Some mental health care organizations are currently trying to recruit new workers with bonuses or new incentives, but longer-term fixes are likely to require a hard look at the degree to which our actual commitment to mental health care matches the political rhetoric.

Discussions of how to solve the problem of ED boarding can easily deteriorate into a lot of finger pointing of what somebody else should be doing. The truth is, however, that there are many actions that can be taken by those in very different roles.

While many of these steps require efforts from mental health organizations, emergency departments, government agencies, and hospitals, there are things that can be done within the purview of the primary care clinician. First, look for opportunities to increase your collaboration with mental health professionals through initiatives such as integrated care programs. The Health Resources and Services Administration is now using funds from the American Rescue Plan Act to strengthen integrated care programs across the country and new opportunities may well be available soon to get additional mental health supports to primary care offices. Second, get involved and advocate for the mental health of your patients by communicating with other groups to make other potential solutions a reality.

Children and adolescents waiting for days to get the mental health care they need and deserve is an unacceptable situation that we can and must overcome. Quick fixes will be hard to find, but with some collaborative effort, forward thinking, and, yes, financial investments, we can find solutions that reflect the principle of mental health being a foundation for all health.

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont, Burlington. Follow him on Twitter @PediPsych. His latest book is “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood.”

References

1. Tabachnik S. Colorado health leaders declare youth mental health state of emergency: “Our kids have run out of resilience.” Denver Post. 2021 May 25. 

2. Bebinger M. Kids in mental health crisis can languish for days inside ERs. National Public Radio. 2021 Jun 23.

3. Nash KA et al. Pediatrics. 2021:147:5. e2020030692.

The U.S. Food and Drug Administration has declined to approve the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) for the delay of type 1 diabetes in at-risk individuals, despite narrow endorsement in a 10-7 vote in favor of approval by one of its advisory panels in May.

According to the company, the FDA did not cite any clinical deficiencies related to the efficacy and safety data packages submitted as part of the biologics license application for teplizumab.

Rather, the sticking point appears to be a study in healthy volunteers that had been raised as an issue with Provention Bio in April.

That study was designed to compare the planned commercial product with the product originally manufactured for clinical trials, but the former was not pharmacologically comparable to the latter, the FDA said in its complete response letter, issued on July 2.

The company expects, later this quarter, to obtain data from a substudy in patients receiving 12 days of therapy in the ongoing PROTECT trial of newly diagnosed patients with type 1 diabetes, which it hopes will help alleviate the FDA’s concerns.

“Upon review of the results from this substudy, the company will determine whether to submit these data to the FDA for its review ... to support pharmacokinetic comparability or otherwise justify why pharmacokinetic comparability is not necessary,” it said in its statement.

The FDA’s complete response letter had also mentioned additional issues related to product quality that Provention believes it has or will be able to address in the short term.

Teplizumab delays type 1 diabetes onset by years

Phase 2 data showing that a 14-day teplizumab infusion delayed the onset of type 1 diabetes by 2 years in high-risk relatives of people with the condition were called “game-changing” when presented at the American Diabetes Association 2019 Scientific Sessions and simultaneously published in the New England Journal of Medicine. These were the data considered by the FDA advisory panel in May.

In response to the FDA decision, the type 1 diabetes research and advocacy organization JDRF said: “It is unfortunate that the FDA has not approved teplizumab at this time and instead has requested additional information from the sponsor. We look forward to Provention Bio addressing the issues outlined in the Complete Response Letter and working with the FDA to bring this option to market safely.”

Teplizumab is one of several potential disease-modifying therapies being studied for type 1 diabetes administered either soon after diagnosis or to asymptomatic individuals with high-risk autoantibodies.

“Disease-modifying therapies such as teplizumab will help address the unmet needs of people with type 1 diabetes and those at risk for developing the disease. In the meantime, our organization will continue to support the research of other disease-modifying therapies that put us on the critical pathway to preventing and ultimately curing type 1 diabetes,” JDRF said in a statement.

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

The U.S. Food and Drug Administration has declined to approve the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) for the delay of type 1 diabetes in at-risk individuals, despite narrow endorsement in a 10-7 vote in favor of approval by one of its advisory panels in May.

According to the company, the FDA did not cite any clinical deficiencies related to the efficacy and safety data packages submitted as part of the biologics license application for teplizumab.

Rather, the sticking point appears to be a study in healthy volunteers that had been raised as an issue with Provention Bio in April.

That study was designed to compare the planned commercial product with the product originally manufactured for clinical trials, but the former was not pharmacologically comparable to the latter, the FDA said in its complete response letter, issued on July 2.

The company expects, later this quarter, to obtain data from a substudy in patients receiving 12 days of therapy in the ongoing PROTECT trial of newly diagnosed patients with type 1 diabetes, which it hopes will help alleviate the FDA’s concerns.

“Upon review of the results from this substudy, the company will determine whether to submit these data to the FDA for its review ... to support pharmacokinetic comparability or otherwise justify why pharmacokinetic comparability is not necessary,” it said in its statement.

The FDA’s complete response letter had also mentioned additional issues related to product quality that Provention believes it has or will be able to address in the short term.

Teplizumab delays type 1 diabetes onset by years

Phase 2 data showing that a 14-day teplizumab infusion delayed the onset of type 1 diabetes by 2 years in high-risk relatives of people with the condition were called “game-changing” when presented at the American Diabetes Association 2019 Scientific Sessions and simultaneously published in the New England Journal of Medicine. These were the data considered by the FDA advisory panel in May.

In response to the FDA decision, the type 1 diabetes research and advocacy organization JDRF said: “It is unfortunate that the FDA has not approved teplizumab at this time and instead has requested additional information from the sponsor. We look forward to Provention Bio addressing the issues outlined in the Complete Response Letter and working with the FDA to bring this option to market safely.”

Teplizumab is one of several potential disease-modifying therapies being studied for type 1 diabetes administered either soon after diagnosis or to asymptomatic individuals with high-risk autoantibodies.

“Disease-modifying therapies such as teplizumab will help address the unmet needs of people with type 1 diabetes and those at risk for developing the disease. In the meantime, our organization will continue to support the research of other disease-modifying therapies that put us on the critical pathway to preventing and ultimately curing type 1 diabetes,” JDRF said in a statement.

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

The U.S. Food and Drug Administration has declined to approve the anti-CD3 monoclonal antibody teplizumab (Tzield, Provention Bio) for the delay of type 1 diabetes in at-risk individuals, despite narrow endorsement in a 10-7 vote in favor of approval by one of its advisory panels in May.

According to the company, the FDA did not cite any clinical deficiencies related to the efficacy and safety data packages submitted as part of the biologics license application for teplizumab.

Rather, the sticking point appears to be a study in healthy volunteers that had been raised as an issue with Provention Bio in April.

That study was designed to compare the planned commercial product with the product originally manufactured for clinical trials, but the former was not pharmacologically comparable to the latter, the FDA said in its complete response letter, issued on July 2.

The company expects, later this quarter, to obtain data from a substudy in patients receiving 12 days of therapy in the ongoing PROTECT trial of newly diagnosed patients with type 1 diabetes, which it hopes will help alleviate the FDA’s concerns.

“Upon review of the results from this substudy, the company will determine whether to submit these data to the FDA for its review ... to support pharmacokinetic comparability or otherwise justify why pharmacokinetic comparability is not necessary,” it said in its statement.

The FDA’s complete response letter had also mentioned additional issues related to product quality that Provention believes it has or will be able to address in the short term.

Teplizumab delays type 1 diabetes onset by years

Phase 2 data showing that a 14-day teplizumab infusion delayed the onset of type 1 diabetes by 2 years in high-risk relatives of people with the condition were called “game-changing” when presented at the American Diabetes Association 2019 Scientific Sessions and simultaneously published in the New England Journal of Medicine. These were the data considered by the FDA advisory panel in May.

In response to the FDA decision, the type 1 diabetes research and advocacy organization JDRF said: “It is unfortunate that the FDA has not approved teplizumab at this time and instead has requested additional information from the sponsor. We look forward to Provention Bio addressing the issues outlined in the Complete Response Letter and working with the FDA to bring this option to market safely.”

Teplizumab is one of several potential disease-modifying therapies being studied for type 1 diabetes administered either soon after diagnosis or to asymptomatic individuals with high-risk autoantibodies.

“Disease-modifying therapies such as teplizumab will help address the unmet needs of people with type 1 diabetes and those at risk for developing the disease. In the meantime, our organization will continue to support the research of other disease-modifying therapies that put us on the critical pathway to preventing and ultimately curing type 1 diabetes,” JDRF said in a statement.

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

The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.

Almost 285,000 children aged 12-15 got their first dose of the COVID vaccine in the week ending July 4, stopping a trend that saw weekly vaccinations drop from 1.44 million for May 18-24 to 283,000 during June 22-28, the CDC reported on its COVID Data Tracker site.

As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.

Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.

The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.

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The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.

Almost 285,000 children aged 12-15 got their first dose of the COVID vaccine in the week ending July 4, stopping a trend that saw weekly vaccinations drop from 1.44 million for May 18-24 to 283,000 during June 22-28, the CDC reported on its COVID Data Tracker site.

As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.

Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.

The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.

[email protected]

The weekly number of 12- to 15-year-olds receiving a first dose of COVID-19 vaccine rose slightly, but the age group’s share of all first vaccinations continues to drop, according to data from the Centers for Disease Control and Prevention.

Almost 285,000 children aged 12-15 got their first dose of the COVID vaccine in the week ending July 4, stopping a trend that saw weekly vaccinations drop from 1.44 million for May 18-24 to 283,000 during June 22-28, the CDC reported on its COVID Data Tracker site.

As of July 5, not quite one-third (32.2%) of 12- to 15-year-olds had received at least one dose of the vaccine and 23.4% were fully vaccinated. For those aged 16-17 years, 44.5% have gotten at least one dose and 35.9% are fully vaccinated. Total numbers of fully vaccinated individuals in each age group are 4.9 million (12-15) and 3.4 million (16-17), the CDC said.

Looking at another measure, percentage of all vaccines initiated by each age group over the previous 14 days, shows that the decline has not stopped for those aged 12-15. They represented 12.1% of all first vaccines administered during the 2 weeks ending July 4, compared with 14.3% on June 28 and 23.4% (the highest proportion reached) on May 30. The 16- and 17-year olds were at 4.6% on July 4, but that figure has only ranged from 4.2% to 4.9% since late May, based on CDC data.

The numbers for full vaccination follow a similar trajectory. Children aged 12-15 represented 12.1% of all those completing the vaccine regimen over the 2 weeks ending July 4, down from 16.7% a week earlier (June 28) and from a high of 21.5% for the 2 weeks ending June 21. Full vaccination for 16- and 17-year-olds matched their pattern for first doses: nothing lower than 4.2% or higher than 4.6%, the COVID Data Tracker shows.

[email protected]

Evaluation of a large insurance claims database has provided some insight into how ICD-10 indoor tanning codes are being used in practice, according to a study presented at the annual meeting of the Society for Investigative Dermatology.

thinkstockphotos.com

“Since indoor tanning ICD-10 codes were only recently universally implemented in 2015, and providers may still be using other codes that cover similar services, we think our data likely underestimate the number of encounters and sequelae associated with indoor tanning,” Alexandria M. Brown, BSA, of Baylor College of Medicine, Houston, said in her presentation. “We think increased usage of these indoor tanning exposure codes in coming years will strengthen this body of indoor tanning literature and data.”

Using insurance claims data on about 43 million patients from Truven Health MarketScan, Ms. Brown and colleagues analyzed patient encounters with ICD-10 indoor tanning codes W89.1, W89.1XXA, W89.1XXD, and W89.1XXS between 2016 and 2018 for about 43 million patients. Overall, there were 4,550 patient encounters where these codes had been recorded, with most (99%) occurring in an outpatient setting. The majority of providers at these encounters were dermatologists (72%). Patients were mostly women (85%); and most were ages 25-34 years (19.4%), 35-44 years (20.6%), 45-54 years (22.7%), and 55-64 years (19%). Almost 5% were 65 and over, 11.7% were ages 18-24, and 1.6% were under age 18.

The use of indoor tanning codes were most common in the Midwest (55 per 100,000 encounters with dermatologists), compared with 16 per 100,000 in the Northeast, 21 per 100,000 in the West, and 28 per 100,000 in the South. CPT codes for “destruction of a premalignant lesion” and “biopsy” were the most frequently used codes entered at visits where indoor tanning codes were also entered, and were present in 15.1% of encounters and 18.4% of encounters, respectively.

“This suggests that many of these encounters may have been for skin cancer surveillance and that indoor tanning exposure may have been coded as part of a patient’s skin cancer risk profile,” Ms. Brown noted.

The study shows how these codes are being used and could help determine health care use patterns for these patients as well as their comorbidities, behaviors, and risk factors, according to the authors, who believe this is the first study to look at the use of ICD-10 indoor tanning codes.

“Any effort to reduce indoor tanning requires knowledge of the population at risk. It has been shown that the ability to recognize and provide counseling to at-risk patients can improve sun protective behaviors and reduce indoor tanning,” Ms. Brown said. Claims databases can be a “valuable tool to better understand patients who have been exposed to indoor tanning and their associated risk factors, comorbidities, behaviors, and health care utilization.”

In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said the study was interesting and “provides some guidance with respect to who, when, and where in the U.S. to target educational initiatives on the harms of tanning beds.”

Dr. Friedman, who was not involved with the research, agreed with the authors’ assertion that their study was underestimating the use of indoor tanning beds. “Using a large database provides the means to better generalize one’s dataset; however in this case, it relies on proper coding by the practitioner,” or even using the code for tanning bed use at all.

“There also could be some inherent bias given most of the cases for which the code was used was for skin cancer surveillance, and therefore tanning bed use was top of mind,” he said.

While he believes this study may not be most efficient way of determining demographics of at-risk individuals using tanning beds, Dr. Friedman said the results “should serve as the impetus to develop public health campaigns around this information, following which research can be conducted to evaluate if the intervention had an impact.”

Ms. Brown and Dr. Friedman reported no relevant financial disclosures.

Evaluation of a large insurance claims database has provided some insight into how ICD-10 indoor tanning codes are being used in practice, according to a study presented at the annual meeting of the Society for Investigative Dermatology.

thinkstockphotos.com

“Since indoor tanning ICD-10 codes were only recently universally implemented in 2015, and providers may still be using other codes that cover similar services, we think our data likely underestimate the number of encounters and sequelae associated with indoor tanning,” Alexandria M. Brown, BSA, of Baylor College of Medicine, Houston, said in her presentation. “We think increased usage of these indoor tanning exposure codes in coming years will strengthen this body of indoor tanning literature and data.”

Using insurance claims data on about 43 million patients from Truven Health MarketScan, Ms. Brown and colleagues analyzed patient encounters with ICD-10 indoor tanning codes W89.1, W89.1XXA, W89.1XXD, and W89.1XXS between 2016 and 2018 for about 43 million patients. Overall, there were 4,550 patient encounters where these codes had been recorded, with most (99%) occurring in an outpatient setting. The majority of providers at these encounters were dermatologists (72%). Patients were mostly women (85%); and most were ages 25-34 years (19.4%), 35-44 years (20.6%), 45-54 years (22.7%), and 55-64 years (19%). Almost 5% were 65 and over, 11.7% were ages 18-24, and 1.6% were under age 18.

The use of indoor tanning codes were most common in the Midwest (55 per 100,000 encounters with dermatologists), compared with 16 per 100,000 in the Northeast, 21 per 100,000 in the West, and 28 per 100,000 in the South. CPT codes for “destruction of a premalignant lesion” and “biopsy” were the most frequently used codes entered at visits where indoor tanning codes were also entered, and were present in 15.1% of encounters and 18.4% of encounters, respectively.

“This suggests that many of these encounters may have been for skin cancer surveillance and that indoor tanning exposure may have been coded as part of a patient’s skin cancer risk profile,” Ms. Brown noted.

The study shows how these codes are being used and could help determine health care use patterns for these patients as well as their comorbidities, behaviors, and risk factors, according to the authors, who believe this is the first study to look at the use of ICD-10 indoor tanning codes.

“Any effort to reduce indoor tanning requires knowledge of the population at risk. It has been shown that the ability to recognize and provide counseling to at-risk patients can improve sun protective behaviors and reduce indoor tanning,” Ms. Brown said. Claims databases can be a “valuable tool to better understand patients who have been exposed to indoor tanning and their associated risk factors, comorbidities, behaviors, and health care utilization.”

In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said the study was interesting and “provides some guidance with respect to who, when, and where in the U.S. to target educational initiatives on the harms of tanning beds.”

Dr. Friedman, who was not involved with the research, agreed with the authors’ assertion that their study was underestimating the use of indoor tanning beds. “Using a large database provides the means to better generalize one’s dataset; however in this case, it relies on proper coding by the practitioner,” or even using the code for tanning bed use at all.

“There also could be some inherent bias given most of the cases for which the code was used was for skin cancer surveillance, and therefore tanning bed use was top of mind,” he said.

While he believes this study may not be most efficient way of determining demographics of at-risk individuals using tanning beds, Dr. Friedman said the results “should serve as the impetus to develop public health campaigns around this information, following which research can be conducted to evaluate if the intervention had an impact.”

Ms. Brown and Dr. Friedman reported no relevant financial disclosures.

Evaluation of a large insurance claims database has provided some insight into how ICD-10 indoor tanning codes are being used in practice, according to a study presented at the annual meeting of the Society for Investigative Dermatology.

thinkstockphotos.com

“Since indoor tanning ICD-10 codes were only recently universally implemented in 2015, and providers may still be using other codes that cover similar services, we think our data likely underestimate the number of encounters and sequelae associated with indoor tanning,” Alexandria M. Brown, BSA, of Baylor College of Medicine, Houston, said in her presentation. “We think increased usage of these indoor tanning exposure codes in coming years will strengthen this body of indoor tanning literature and data.”

Using insurance claims data on about 43 million patients from Truven Health MarketScan, Ms. Brown and colleagues analyzed patient encounters with ICD-10 indoor tanning codes W89.1, W89.1XXA, W89.1XXD, and W89.1XXS between 2016 and 2018 for about 43 million patients. Overall, there were 4,550 patient encounters where these codes had been recorded, with most (99%) occurring in an outpatient setting. The majority of providers at these encounters were dermatologists (72%). Patients were mostly women (85%); and most were ages 25-34 years (19.4%), 35-44 years (20.6%), 45-54 years (22.7%), and 55-64 years (19%). Almost 5% were 65 and over, 11.7% were ages 18-24, and 1.6% were under age 18.

The use of indoor tanning codes were most common in the Midwest (55 per 100,000 encounters with dermatologists), compared with 16 per 100,000 in the Northeast, 21 per 100,000 in the West, and 28 per 100,000 in the South. CPT codes for “destruction of a premalignant lesion” and “biopsy” were the most frequently used codes entered at visits where indoor tanning codes were also entered, and were present in 15.1% of encounters and 18.4% of encounters, respectively.

“This suggests that many of these encounters may have been for skin cancer surveillance and that indoor tanning exposure may have been coded as part of a patient’s skin cancer risk profile,” Ms. Brown noted.

The study shows how these codes are being used and could help determine health care use patterns for these patients as well as their comorbidities, behaviors, and risk factors, according to the authors, who believe this is the first study to look at the use of ICD-10 indoor tanning codes.

“Any effort to reduce indoor tanning requires knowledge of the population at risk. It has been shown that the ability to recognize and provide counseling to at-risk patients can improve sun protective behaviors and reduce indoor tanning,” Ms. Brown said. Claims databases can be a “valuable tool to better understand patients who have been exposed to indoor tanning and their associated risk factors, comorbidities, behaviors, and health care utilization.”

In an interview, Adam Friedman, MD, professor and chair of dermatology at George Washington University, Washington, said the study was interesting and “provides some guidance with respect to who, when, and where in the U.S. to target educational initiatives on the harms of tanning beds.”

Dr. Friedman, who was not involved with the research, agreed with the authors’ assertion that their study was underestimating the use of indoor tanning beds. “Using a large database provides the means to better generalize one’s dataset; however in this case, it relies on proper coding by the practitioner,” or even using the code for tanning bed use at all.

“There also could be some inherent bias given most of the cases for which the code was used was for skin cancer surveillance, and therefore tanning bed use was top of mind,” he said.

While he believes this study may not be most efficient way of determining demographics of at-risk individuals using tanning beds, Dr. Friedman said the results “should serve as the impetus to develop public health campaigns around this information, following which research can be conducted to evaluate if the intervention had an impact.”

Ms. Brown and Dr. Friedman reported no relevant financial disclosures.

Physical punishment doesn’t improve a child’s behavior or social competence, and in fact, it can make behavior worse, according to a new study published June 28, 2021, in The Lancet.

Spanking and hitting can also harm a child’s development and well-being, the authors wrote.

“Parents hit their children because they think doing so will improve their behavior,” Elizabeth Gershoff, PhD, the senior author and a human development professor at the University of Texas at Austin, told CNN. “Unfortunately for parents who hit, our research found clear and compelling evidence that physical punishment does not improve children’s behavior and instead makes it worse.”

Dr. Gershoff and colleagues reviewed 69 studies from numerous countries, including the United States, United Kingdom, Canada, China, Colombia, Greece, Japan, Switzerland, and Turkey. They focused on spanking and other physical punishment that parents might use to discipline a child, excluding verbal punishment and “severe” physical punishment such as punching or kicking that could be characterized as child abuse.

Some studies in the review found a mix of positive and negative results from spanking. But most of the studies showed a significant negative impact.

In 13 of 19 studies, spanking and other forms of physical punishment created more external negative behaviors over time, including increased aggression, increased antisocial behavior, and increased disruptive behavior at school. Children were more likely to “act out” after being physically punished, regardless of the child’s gender, race, or ethnicity, the authors found.

Several studies found that physical punishment increased signs of oppositional defiant disorder, which is linked with temper tantrums, spitefulness, vindictiveness, argumentative behavior, active defiance, and refusal to follow rules.

Dr. Gershoff and colleagues also looked at the link between how often physical punishment happened and a child’s negative behavior in seven of the studies. In five of those studies, there was a “dose-response effect.”

“In other words, as physical punishment increased in frequency, so did its likelihood of predicting worse outcomes over time,” Dr. Gershoff told CNN.

In addition, the review found that negative behavior wasn’t changed by parenting style. Even if parents had an overall warm and positive parenting style, physical punishment still led to an increase in behavioral issues.

In the United States, all 50 states allow parents to use physical punishment on children, and 19 states still have laws that allow schools to use corporal punishment, CNN reported.

But spanking appears to be declining in the United States, particularly among younger generations, according to a research letter published in JAMA Pediatrics in 2020. About 50% of parents reported spanking a child in 1993, which dropped to 35% in 2017.

The American Academy of Pediatrics issued a policy statement in 2018 in favor of “healthy forms of discipline,” such as positive reinforcement of good behavior, setting limits, and giving consequences such as time-out or taking away toys or privileges. The group recommends against spanking, hitting, slapping, threatening, insulting, humiliating, or shaming children, which can lead to behavioral problems and symptoms of depression in later years.

The AAP also suggests learning from mistakes, both for parents and children.

“Remember that, as a parent, you can give yourself a time out if you feel out of control,” the group wrote in a discipline tip sheet. “When you are feeling better, go back to your child, hug each other, and start over.”

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

Physical punishment doesn’t improve a child’s behavior or social competence, and in fact, it can make behavior worse, according to a new study published June 28, 2021, in The Lancet.

Spanking and hitting can also harm a child’s development and well-being, the authors wrote.

“Parents hit their children because they think doing so will improve their behavior,” Elizabeth Gershoff, PhD, the senior author and a human development professor at the University of Texas at Austin, told CNN. “Unfortunately for parents who hit, our research found clear and compelling evidence that physical punishment does not improve children’s behavior and instead makes it worse.”

Dr. Gershoff and colleagues reviewed 69 studies from numerous countries, including the United States, United Kingdom, Canada, China, Colombia, Greece, Japan, Switzerland, and Turkey. They focused on spanking and other physical punishment that parents might use to discipline a child, excluding verbal punishment and “severe” physical punishment such as punching or kicking that could be characterized as child abuse.

Some studies in the review found a mix of positive and negative results from spanking. But most of the studies showed a significant negative impact.

In 13 of 19 studies, spanking and other forms of physical punishment created more external negative behaviors over time, including increased aggression, increased antisocial behavior, and increased disruptive behavior at school. Children were more likely to “act out” after being physically punished, regardless of the child’s gender, race, or ethnicity, the authors found.

Several studies found that physical punishment increased signs of oppositional defiant disorder, which is linked with temper tantrums, spitefulness, vindictiveness, argumentative behavior, active defiance, and refusal to follow rules.

Dr. Gershoff and colleagues also looked at the link between how often physical punishment happened and a child’s negative behavior in seven of the studies. In five of those studies, there was a “dose-response effect.”

“In other words, as physical punishment increased in frequency, so did its likelihood of predicting worse outcomes over time,” Dr. Gershoff told CNN.

In addition, the review found that negative behavior wasn’t changed by parenting style. Even if parents had an overall warm and positive parenting style, physical punishment still led to an increase in behavioral issues.

In the United States, all 50 states allow parents to use physical punishment on children, and 19 states still have laws that allow schools to use corporal punishment, CNN reported.

But spanking appears to be declining in the United States, particularly among younger generations, according to a research letter published in JAMA Pediatrics in 2020. About 50% of parents reported spanking a child in 1993, which dropped to 35% in 2017.

The American Academy of Pediatrics issued a policy statement in 2018 in favor of “healthy forms of discipline,” such as positive reinforcement of good behavior, setting limits, and giving consequences such as time-out or taking away toys or privileges. The group recommends against spanking, hitting, slapping, threatening, insulting, humiliating, or shaming children, which can lead to behavioral problems and symptoms of depression in later years.

The AAP also suggests learning from mistakes, both for parents and children.

“Remember that, as a parent, you can give yourself a time out if you feel out of control,” the group wrote in a discipline tip sheet. “When you are feeling better, go back to your child, hug each other, and start over.”

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

Physical punishment doesn’t improve a child’s behavior or social competence, and in fact, it can make behavior worse, according to a new study published June 28, 2021, in The Lancet.

Spanking and hitting can also harm a child’s development and well-being, the authors wrote.

“Parents hit their children because they think doing so will improve their behavior,” Elizabeth Gershoff, PhD, the senior author and a human development professor at the University of Texas at Austin, told CNN. “Unfortunately for parents who hit, our research found clear and compelling evidence that physical punishment does not improve children’s behavior and instead makes it worse.”

Dr. Gershoff and colleagues reviewed 69 studies from numerous countries, including the United States, United Kingdom, Canada, China, Colombia, Greece, Japan, Switzerland, and Turkey. They focused on spanking and other physical punishment that parents might use to discipline a child, excluding verbal punishment and “severe” physical punishment such as punching or kicking that could be characterized as child abuse.

Some studies in the review found a mix of positive and negative results from spanking. But most of the studies showed a significant negative impact.

In 13 of 19 studies, spanking and other forms of physical punishment created more external negative behaviors over time, including increased aggression, increased antisocial behavior, and increased disruptive behavior at school. Children were more likely to “act out” after being physically punished, regardless of the child’s gender, race, or ethnicity, the authors found.

Several studies found that physical punishment increased signs of oppositional defiant disorder, which is linked with temper tantrums, spitefulness, vindictiveness, argumentative behavior, active defiance, and refusal to follow rules.

Dr. Gershoff and colleagues also looked at the link between how often physical punishment happened and a child’s negative behavior in seven of the studies. In five of those studies, there was a “dose-response effect.”

“In other words, as physical punishment increased in frequency, so did its likelihood of predicting worse outcomes over time,” Dr. Gershoff told CNN.

In addition, the review found that negative behavior wasn’t changed by parenting style. Even if parents had an overall warm and positive parenting style, physical punishment still led to an increase in behavioral issues.

In the United States, all 50 states allow parents to use physical punishment on children, and 19 states still have laws that allow schools to use corporal punishment, CNN reported.

But spanking appears to be declining in the United States, particularly among younger generations, according to a research letter published in JAMA Pediatrics in 2020. About 50% of parents reported spanking a child in 1993, which dropped to 35% in 2017.

The American Academy of Pediatrics issued a policy statement in 2018 in favor of “healthy forms of discipline,” such as positive reinforcement of good behavior, setting limits, and giving consequences such as time-out or taking away toys or privileges. The group recommends against spanking, hitting, slapping, threatening, insulting, humiliating, or shaming children, which can lead to behavioral problems and symptoms of depression in later years.

The AAP also suggests learning from mistakes, both for parents and children.

“Remember that, as a parent, you can give yourself a time out if you feel out of control,” the group wrote in a discipline tip sheet. “When you are feeling better, go back to your child, hug each other, and start over.”

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