Adolescent Medicine

Brain indicators of motor impairment were distinct among children with autism spectrum disorder (ASD), those with developmental coordination disorder (DCD), and controls, in a new study.

Previous research suggests that individuals with ASD overlap in motor impairment with those with DCD. But these two conditions may differ significantly in some areas, as children with ASD tend to show weaker skills in social motor tasks such as imitation, wrote Emil Kilroy, PhD, of the University of Southern California, Los Angeles, and colleagues.

The neurobiological basis of autism remains unknown, despite many research efforts, in part because of the heterogeneity of the disease, said corresponding author Lisa Aziz-Zadeh, PhD, also of the University of Southern California, in an interview.

Comorbidity with other disorders is a strong contributing factor to heterogeneity, and approximately 80% of autistic individuals have motor impairments and meet criteria for a diagnosis of DCD, said Dr. Aziz-Zadeh. “Controlling for other comorbidities, such as developmental coordination disorder, when trying to understand the neural basis of autism is important, so that we can understand which neural circuits are related to [core symptoms of autism] and which ones are related to motor impairments that are comorbid with autism, but not necessarily part of the core symptomology,” she explained. “We focused on white matter pathways here because many researchers now think the underlying basis of autism, besides genetics, is brain connectivity differences.”

In their study published in Scientific Reports, the researchers reviewed data from whole-brain correlational tractography for 22 individuals with autism spectrum disorder, 16 with developmental coordination disorder, and 21 normally developing individuals, who served as the control group. The mean age of the participants was approximately 11 years; the age range was 8-17 years.

Overall, patterns of brain diffusion (movement of fluid, mainly water molecules, in the brain) were significantly different in ASD children, compared with typically developing children.

The ASD group showed significantly reduced diffusivity in the bilateral fronto-parietal cingulum and the left parolfactory cingulum. This finding reflects previous studies suggesting an association between brain patterns in the cingulum area and ASD. But the current study is “the first to identify the fronto-parietal and the parolfactory portions of the cingulum as well as the anterior caudal u-fibers as specific to core ASD symptomatology and not related to motor-related comorbidity,” the researchers wrote.

Differences in brain diffusivity were associated with worse performance on motor skills and behavioral measures for children with ASD and children with DCD, compared with controls.

Motor development was assessed using the Total Movement Assessment Battery for Children-2 (MABC-2) and the Florida Apraxia Battery modified for children (FAB-M). The MABC-2 is among the most common tools for measuring motor skills and identifying clinically relevant motor deficits in children and teens aged 3-16 years. The test includes three subtest scores (manual dexterity, gross-motor aiming and catching, and balance) and a total score. Scores are based on a child’s best performance on each component, and higher scores indicate better functioning. In the new study, The MABC-2 total scores averaged 10.57 for controls, compared with 5.76 in the ASD group, and 4.31 in the DCD group.

Children with ASD differed from the other groups in social measures. Social skills were measured using several tools, including the Social Responsivity Scale (SRS Total), which is a parent-completed survey that includes a total score designed to reflect the severity of social deficits in ASD. It is divided into five subscales for parents to assess a child’s social skill impairment: social awareness, social cognition, social communication, social motivation, and mannerisms. Scores for the SRS are calculated in T-scores, in which a score of 50 represents the mean. T-scores of 59 and below are generally not associated with ASD, and patients with these scores are considered to have low to no symptomatology. Scores on the SRS Total in the new study were 45.95, 77.45, and 55.81 for the controls, ASD group, and DCD group, respectively.
 

Results should raise awareness

“The results were largely predicted in our hypotheses – that we would find specific white matter pathways in autism that would differ from [what we saw in typically developing patients and those with DCD], and that diffusivity in ASD would be related to socioemotional differences,” Dr. Aziz-Zadeh said, in an interview.

“What was surprising was that some pathways that had previously been thought to be different in autism were also compromised in DCD, indicating that they were common to motor deficits which both groups shared, not to core autism symptomology,” she noted.

A message for clinicians from the study is that a dual diagnosis of DCD is often missing in ASD practice, said Dr. Aziz-Zadeh. “Given that approximately 80% of children with ASD have DCD, testing for DCD and addressing potential motor issues should be more common practice,” she said.

Dr. Aziz-Zadeh and colleagues are now investigating relationships between the brain, behavior, and the gut microbiome. “We think that understanding autism from a full-body perspective, examining interactions between the brain and the body, will be an important step in this field,” she emphasized.

The study was limited by several factors, including the small sample size, the use of only right-handed participants, and the use of self-reports by children and parents, the researchers noted. Additionally, they noted that white matter develops at different rates in different age groups, and future studies might consider age as a factor, as well as further behavioral assessments, they said.
 

Small sample size limits conclusions

“Understanding the neuroanatomic differences that may contribute to the core symptoms of ASD is a very important goal for the field, particularly how they relate to other comorbid symptoms and neurodevelopmental disorders,” said Michael Gandal, MD, of the department of psychiatry at the University of Pennsylvania, Philadelphia, and a member of the Lifespan Brain Institute at the Children’s Hospital of Philadelphia, in an interview.

“While this study provides some clues into how structural connectivity may relate to motor coordination in ASD, it will be important to replicate these findings in a much larger sample before we can really appreciate how robust these findings are and how well they generalize to the broader ASD population,” Dr. Gandal emphasized.

The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers had no financial conflicts to disclose. Dr. Gandal had no financial conflicts to disclose.

Brain indicators of motor impairment were distinct among children with autism spectrum disorder (ASD), those with developmental coordination disorder (DCD), and controls, in a new study.

Previous research suggests that individuals with ASD overlap in motor impairment with those with DCD. But these two conditions may differ significantly in some areas, as children with ASD tend to show weaker skills in social motor tasks such as imitation, wrote Emil Kilroy, PhD, of the University of Southern California, Los Angeles, and colleagues.

The neurobiological basis of autism remains unknown, despite many research efforts, in part because of the heterogeneity of the disease, said corresponding author Lisa Aziz-Zadeh, PhD, also of the University of Southern California, in an interview.

Comorbidity with other disorders is a strong contributing factor to heterogeneity, and approximately 80% of autistic individuals have motor impairments and meet criteria for a diagnosis of DCD, said Dr. Aziz-Zadeh. “Controlling for other comorbidities, such as developmental coordination disorder, when trying to understand the neural basis of autism is important, so that we can understand which neural circuits are related to [core symptoms of autism] and which ones are related to motor impairments that are comorbid with autism, but not necessarily part of the core symptomology,” she explained. “We focused on white matter pathways here because many researchers now think the underlying basis of autism, besides genetics, is brain connectivity differences.”

In their study published in Scientific Reports, the researchers reviewed data from whole-brain correlational tractography for 22 individuals with autism spectrum disorder, 16 with developmental coordination disorder, and 21 normally developing individuals, who served as the control group. The mean age of the participants was approximately 11 years; the age range was 8-17 years.

Overall, patterns of brain diffusion (movement of fluid, mainly water molecules, in the brain) were significantly different in ASD children, compared with typically developing children.

The ASD group showed significantly reduced diffusivity in the bilateral fronto-parietal cingulum and the left parolfactory cingulum. This finding reflects previous studies suggesting an association between brain patterns in the cingulum area and ASD. But the current study is “the first to identify the fronto-parietal and the parolfactory portions of the cingulum as well as the anterior caudal u-fibers as specific to core ASD symptomatology and not related to motor-related comorbidity,” the researchers wrote.

Differences in brain diffusivity were associated with worse performance on motor skills and behavioral measures for children with ASD and children with DCD, compared with controls.

Motor development was assessed using the Total Movement Assessment Battery for Children-2 (MABC-2) and the Florida Apraxia Battery modified for children (FAB-M). The MABC-2 is among the most common tools for measuring motor skills and identifying clinically relevant motor deficits in children and teens aged 3-16 years. The test includes three subtest scores (manual dexterity, gross-motor aiming and catching, and balance) and a total score. Scores are based on a child’s best performance on each component, and higher scores indicate better functioning. In the new study, The MABC-2 total scores averaged 10.57 for controls, compared with 5.76 in the ASD group, and 4.31 in the DCD group.

Children with ASD differed from the other groups in social measures. Social skills were measured using several tools, including the Social Responsivity Scale (SRS Total), which is a parent-completed survey that includes a total score designed to reflect the severity of social deficits in ASD. It is divided into five subscales for parents to assess a child’s social skill impairment: social awareness, social cognition, social communication, social motivation, and mannerisms. Scores for the SRS are calculated in T-scores, in which a score of 50 represents the mean. T-scores of 59 and below are generally not associated with ASD, and patients with these scores are considered to have low to no symptomatology. Scores on the SRS Total in the new study were 45.95, 77.45, and 55.81 for the controls, ASD group, and DCD group, respectively.
 

Results should raise awareness

“The results were largely predicted in our hypotheses – that we would find specific white matter pathways in autism that would differ from [what we saw in typically developing patients and those with DCD], and that diffusivity in ASD would be related to socioemotional differences,” Dr. Aziz-Zadeh said, in an interview.

“What was surprising was that some pathways that had previously been thought to be different in autism were also compromised in DCD, indicating that they were common to motor deficits which both groups shared, not to core autism symptomology,” she noted.

A message for clinicians from the study is that a dual diagnosis of DCD is often missing in ASD practice, said Dr. Aziz-Zadeh. “Given that approximately 80% of children with ASD have DCD, testing for DCD and addressing potential motor issues should be more common practice,” she said.

Dr. Aziz-Zadeh and colleagues are now investigating relationships between the brain, behavior, and the gut microbiome. “We think that understanding autism from a full-body perspective, examining interactions between the brain and the body, will be an important step in this field,” she emphasized.

The study was limited by several factors, including the small sample size, the use of only right-handed participants, and the use of self-reports by children and parents, the researchers noted. Additionally, they noted that white matter develops at different rates in different age groups, and future studies might consider age as a factor, as well as further behavioral assessments, they said.
 

Small sample size limits conclusions

“Understanding the neuroanatomic differences that may contribute to the core symptoms of ASD is a very important goal for the field, particularly how they relate to other comorbid symptoms and neurodevelopmental disorders,” said Michael Gandal, MD, of the department of psychiatry at the University of Pennsylvania, Philadelphia, and a member of the Lifespan Brain Institute at the Children’s Hospital of Philadelphia, in an interview.

“While this study provides some clues into how structural connectivity may relate to motor coordination in ASD, it will be important to replicate these findings in a much larger sample before we can really appreciate how robust these findings are and how well they generalize to the broader ASD population,” Dr. Gandal emphasized.

The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers had no financial conflicts to disclose. Dr. Gandal had no financial conflicts to disclose.

Brain indicators of motor impairment were distinct among children with autism spectrum disorder (ASD), those with developmental coordination disorder (DCD), and controls, in a new study.

Previous research suggests that individuals with ASD overlap in motor impairment with those with DCD. But these two conditions may differ significantly in some areas, as children with ASD tend to show weaker skills in social motor tasks such as imitation, wrote Emil Kilroy, PhD, of the University of Southern California, Los Angeles, and colleagues.

The neurobiological basis of autism remains unknown, despite many research efforts, in part because of the heterogeneity of the disease, said corresponding author Lisa Aziz-Zadeh, PhD, also of the University of Southern California, in an interview.

Comorbidity with other disorders is a strong contributing factor to heterogeneity, and approximately 80% of autistic individuals have motor impairments and meet criteria for a diagnosis of DCD, said Dr. Aziz-Zadeh. “Controlling for other comorbidities, such as developmental coordination disorder, when trying to understand the neural basis of autism is important, so that we can understand which neural circuits are related to [core symptoms of autism] and which ones are related to motor impairments that are comorbid with autism, but not necessarily part of the core symptomology,” she explained. “We focused on white matter pathways here because many researchers now think the underlying basis of autism, besides genetics, is brain connectivity differences.”

In their study published in Scientific Reports, the researchers reviewed data from whole-brain correlational tractography for 22 individuals with autism spectrum disorder, 16 with developmental coordination disorder, and 21 normally developing individuals, who served as the control group. The mean age of the participants was approximately 11 years; the age range was 8-17 years.

Overall, patterns of brain diffusion (movement of fluid, mainly water molecules, in the brain) were significantly different in ASD children, compared with typically developing children.

The ASD group showed significantly reduced diffusivity in the bilateral fronto-parietal cingulum and the left parolfactory cingulum. This finding reflects previous studies suggesting an association between brain patterns in the cingulum area and ASD. But the current study is “the first to identify the fronto-parietal and the parolfactory portions of the cingulum as well as the anterior caudal u-fibers as specific to core ASD symptomatology and not related to motor-related comorbidity,” the researchers wrote.

Differences in brain diffusivity were associated with worse performance on motor skills and behavioral measures for children with ASD and children with DCD, compared with controls.

Motor development was assessed using the Total Movement Assessment Battery for Children-2 (MABC-2) and the Florida Apraxia Battery modified for children (FAB-M). The MABC-2 is among the most common tools for measuring motor skills and identifying clinically relevant motor deficits in children and teens aged 3-16 years. The test includes three subtest scores (manual dexterity, gross-motor aiming and catching, and balance) and a total score. Scores are based on a child’s best performance on each component, and higher scores indicate better functioning. In the new study, The MABC-2 total scores averaged 10.57 for controls, compared with 5.76 in the ASD group, and 4.31 in the DCD group.

Children with ASD differed from the other groups in social measures. Social skills were measured using several tools, including the Social Responsivity Scale (SRS Total), which is a parent-completed survey that includes a total score designed to reflect the severity of social deficits in ASD. It is divided into five subscales for parents to assess a child’s social skill impairment: social awareness, social cognition, social communication, social motivation, and mannerisms. Scores for the SRS are calculated in T-scores, in which a score of 50 represents the mean. T-scores of 59 and below are generally not associated with ASD, and patients with these scores are considered to have low to no symptomatology. Scores on the SRS Total in the new study were 45.95, 77.45, and 55.81 for the controls, ASD group, and DCD group, respectively.
 

Results should raise awareness

“The results were largely predicted in our hypotheses – that we would find specific white matter pathways in autism that would differ from [what we saw in typically developing patients and those with DCD], and that diffusivity in ASD would be related to socioemotional differences,” Dr. Aziz-Zadeh said, in an interview.

“What was surprising was that some pathways that had previously been thought to be different in autism were also compromised in DCD, indicating that they were common to motor deficits which both groups shared, not to core autism symptomology,” she noted.

A message for clinicians from the study is that a dual diagnosis of DCD is often missing in ASD practice, said Dr. Aziz-Zadeh. “Given that approximately 80% of children with ASD have DCD, testing for DCD and addressing potential motor issues should be more common practice,” she said.

Dr. Aziz-Zadeh and colleagues are now investigating relationships between the brain, behavior, and the gut microbiome. “We think that understanding autism from a full-body perspective, examining interactions between the brain and the body, will be an important step in this field,” she emphasized.

The study was limited by several factors, including the small sample size, the use of only right-handed participants, and the use of self-reports by children and parents, the researchers noted. Additionally, they noted that white matter develops at different rates in different age groups, and future studies might consider age as a factor, as well as further behavioral assessments, they said.
 

Small sample size limits conclusions

“Understanding the neuroanatomic differences that may contribute to the core symptoms of ASD is a very important goal for the field, particularly how they relate to other comorbid symptoms and neurodevelopmental disorders,” said Michael Gandal, MD, of the department of psychiatry at the University of Pennsylvania, Philadelphia, and a member of the Lifespan Brain Institute at the Children’s Hospital of Philadelphia, in an interview.

“While this study provides some clues into how structural connectivity may relate to motor coordination in ASD, it will be important to replicate these findings in a much larger sample before we can really appreciate how robust these findings are and how well they generalize to the broader ASD population,” Dr. Gandal emphasized.

The study was supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development. The researchers had no financial conflicts to disclose. Dr. Gandal had no financial conflicts to disclose.

The Food and Drug Administration has approved the anti-CD3 monoclonal antibody teplizumab-mzwv (Tzield, Provention Bio) to delay the onset of clinical type 1 diabetes in people aged 8 years and older who are at high risk for developing the condition.

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”

The agent, which interferes with T-cell-mediated autoimmune destruction of pancreatic beta cells, is the first disease-modifying therapy for impeding progression of type 1 diabetes. It is administered by intravenous infusion once daily for 14 consecutive days.

The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In type 1 diabetes staging, adopted in 2015, stage 1 is defined as the presence of beta cell autoimmunity with two or more islet autoantibodies with normoglycemia, stage 2 is beta-cell autoimmunity with dysglycemia yet asymptomatic, and stage 3 is the onset of symptomatic type 1 diabetes.

Stage 2 type 1 diabetes is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

The FDA had previously rejected teplizumab for this indication in July 2021, despite a prior endorsement from an advisory panel in May 2021.

Now, with the FDA approval, Provention Bio cofounder and CEO Ashleigh Palmer said in a statement, “This is a historic occasion for the T1D community and a paradigm shifting breakthrough ... It cannot be emphasized enough how precious a delay in the onset of stage 3 T1D can be from a patient and family perspective; more time to live without and, when necessary, prepare for the burdens, complications, and risks associated with stage 3 disease.”
 

T1D onset delayed by 2 years

In 2019, a pivotal phase 2, randomized, placebo-controlled trial involving 76 at-risk children and adults aged 8 years and older showed that a single 14-day treatment of daily intravenous infusions of teplizumab in 44 patients resulted in a significant median 2-year delay to onset of clinical type 1 diabetes compared with 32 who received placebo.

Those “game changer” data were presented at the American Diabetes Association (ADA) annual meeting in June 2019 and simultaneously published in the New England Journal of Medicine.

Three-year data were presented at the June 2020 ADA meeting and published in March 2021 in Science Translational Medicine, by Emily K. Sims, MD, department of pediatrics, Indiana University, Indianapolis, and colleagues.

At a median follow-up of 923 days, 50% of those randomly assigned to teplizumab remained diabetes free, compared with 22% of those who received placebo infusions (hazard ratio, 0.457; P = .01). The teplizumab group had a greater average C-peptide area under the curve compared with placebo, reflecting improved beta-cell function (1.96 vs. 1.68 pmol/mL; P = .006).

C-peptide levels declined over time in the placebo group but stabilized in those receiving teplizumab (P = .0015). 

“The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Tzield and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes,” according to the FDA statement.

The most common side effects of Tzield include lymphopenia (73% teplizumab vs. 6% placebo), rash (36% vs. 0%), leukopenia (221% vs. 0%), and headache (11% vs. 6%). Label warnings and precautions include monitoring for cytokine release syndrome, risk for serious infections, and avoidance of live, inactivated, and mRNA vaccines.

This approval is likely to accelerate discussion about universal autoantibody screening. Currently, most individuals identified as having preclinical type 1 diabetes are first-degree relatives of people with type 1 diabetes identified through the federally funded TrialNet program. In December 2020, the type 1 diabetes research and advocacy organization JDRF began offering a $55 home blood test to screen for the antibodies, and other screening programs have been launched in the United States and Europe.  

Previous studies have examined cost-effectiveness of universal screening in children and the optimal ages that such screening should take place.  

In October, Provention Bio announced a co-promotion agreement with Sanofi for the U.S. launch of Tzield for delay in onset of clinical T1D in at-risk individuals. Provention Bio offers financial assistance options (e.g., copay assistance) to eligible patients for out-of-pocket costs.

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

The Food and Drug Administration has approved the anti-CD3 monoclonal antibody teplizumab-mzwv (Tzield, Provention Bio) to delay the onset of clinical type 1 diabetes in people aged 8 years and older who are at high risk for developing the condition.

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”

The agent, which interferes with T-cell-mediated autoimmune destruction of pancreatic beta cells, is the first disease-modifying therapy for impeding progression of type 1 diabetes. It is administered by intravenous infusion once daily for 14 consecutive days.

The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In type 1 diabetes staging, adopted in 2015, stage 1 is defined as the presence of beta cell autoimmunity with two or more islet autoantibodies with normoglycemia, stage 2 is beta-cell autoimmunity with dysglycemia yet asymptomatic, and stage 3 is the onset of symptomatic type 1 diabetes.

Stage 2 type 1 diabetes is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

The FDA had previously rejected teplizumab for this indication in July 2021, despite a prior endorsement from an advisory panel in May 2021.

Now, with the FDA approval, Provention Bio cofounder and CEO Ashleigh Palmer said in a statement, “This is a historic occasion for the T1D community and a paradigm shifting breakthrough ... It cannot be emphasized enough how precious a delay in the onset of stage 3 T1D can be from a patient and family perspective; more time to live without and, when necessary, prepare for the burdens, complications, and risks associated with stage 3 disease.”
 

T1D onset delayed by 2 years

In 2019, a pivotal phase 2, randomized, placebo-controlled trial involving 76 at-risk children and adults aged 8 years and older showed that a single 14-day treatment of daily intravenous infusions of teplizumab in 44 patients resulted in a significant median 2-year delay to onset of clinical type 1 diabetes compared with 32 who received placebo.

Those “game changer” data were presented at the American Diabetes Association (ADA) annual meeting in June 2019 and simultaneously published in the New England Journal of Medicine.

Three-year data were presented at the June 2020 ADA meeting and published in March 2021 in Science Translational Medicine, by Emily K. Sims, MD, department of pediatrics, Indiana University, Indianapolis, and colleagues.

At a median follow-up of 923 days, 50% of those randomly assigned to teplizumab remained diabetes free, compared with 22% of those who received placebo infusions (hazard ratio, 0.457; P = .01). The teplizumab group had a greater average C-peptide area under the curve compared with placebo, reflecting improved beta-cell function (1.96 vs. 1.68 pmol/mL; P = .006).

C-peptide levels declined over time in the placebo group but stabilized in those receiving teplizumab (P = .0015). 

“The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Tzield and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes,” according to the FDA statement.

The most common side effects of Tzield include lymphopenia (73% teplizumab vs. 6% placebo), rash (36% vs. 0%), leukopenia (221% vs. 0%), and headache (11% vs. 6%). Label warnings and precautions include monitoring for cytokine release syndrome, risk for serious infections, and avoidance of live, inactivated, and mRNA vaccines.

This approval is likely to accelerate discussion about universal autoantibody screening. Currently, most individuals identified as having preclinical type 1 diabetes are first-degree relatives of people with type 1 diabetes identified through the federally funded TrialNet program. In December 2020, the type 1 diabetes research and advocacy organization JDRF began offering a $55 home blood test to screen for the antibodies, and other screening programs have been launched in the United States and Europe.  

Previous studies have examined cost-effectiveness of universal screening in children and the optimal ages that such screening should take place.  

In October, Provention Bio announced a co-promotion agreement with Sanofi for the U.S. launch of Tzield for delay in onset of clinical T1D in at-risk individuals. Provention Bio offers financial assistance options (e.g., copay assistance) to eligible patients for out-of-pocket costs.

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

The Food and Drug Administration has approved the anti-CD3 monoclonal antibody teplizumab-mzwv (Tzield, Provention Bio) to delay the onset of clinical type 1 diabetes in people aged 8 years and older who are at high risk for developing the condition.

“Today’s approval of a first-in-class therapy adds an important new treatment option for certain at-risk patients,” said John Sharretts, MD, director of the Division of Diabetes, Lipid Disorders, and Obesity in the FDA’s Center for Drug Evaluation and Research. “The drug’s potential to delay clinical diagnosis of type 1 diabetes may provide patients with months to years without the burdens of disease.”

The agent, which interferes with T-cell-mediated autoimmune destruction of pancreatic beta cells, is the first disease-modifying therapy for impeding progression of type 1 diabetes. It is administered by intravenous infusion once daily for 14 consecutive days.

The specific indication is “to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.” In type 1 diabetes staging, adopted in 2015, stage 1 is defined as the presence of beta cell autoimmunity with two or more islet autoantibodies with normoglycemia, stage 2 is beta-cell autoimmunity with dysglycemia yet asymptomatic, and stage 3 is the onset of symptomatic type 1 diabetes.

Stage 2 type 1 diabetes is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

The FDA had previously rejected teplizumab for this indication in July 2021, despite a prior endorsement from an advisory panel in May 2021.

Now, with the FDA approval, Provention Bio cofounder and CEO Ashleigh Palmer said in a statement, “This is a historic occasion for the T1D community and a paradigm shifting breakthrough ... It cannot be emphasized enough how precious a delay in the onset of stage 3 T1D can be from a patient and family perspective; more time to live without and, when necessary, prepare for the burdens, complications, and risks associated with stage 3 disease.”
 

T1D onset delayed by 2 years

In 2019, a pivotal phase 2, randomized, placebo-controlled trial involving 76 at-risk children and adults aged 8 years and older showed that a single 14-day treatment of daily intravenous infusions of teplizumab in 44 patients resulted in a significant median 2-year delay to onset of clinical type 1 diabetes compared with 32 who received placebo.

Those “game changer” data were presented at the American Diabetes Association (ADA) annual meeting in June 2019 and simultaneously published in the New England Journal of Medicine.

Three-year data were presented at the June 2020 ADA meeting and published in March 2021 in Science Translational Medicine, by Emily K. Sims, MD, department of pediatrics, Indiana University, Indianapolis, and colleagues.

At a median follow-up of 923 days, 50% of those randomly assigned to teplizumab remained diabetes free, compared with 22% of those who received placebo infusions (hazard ratio, 0.457; P = .01). The teplizumab group had a greater average C-peptide area under the curve compared with placebo, reflecting improved beta-cell function (1.96 vs. 1.68 pmol/mL; P = .006).

C-peptide levels declined over time in the placebo group but stabilized in those receiving teplizumab (P = .0015). 

“The mid-range time from randomization to stage 3 type 1 diabetes diagnosis was 50 months for the patients who received Tzield and 25 months for those who received a placebo. This represents a statistically significant delay in the development of stage 3 type 1 diabetes,” according to the FDA statement.

The most common side effects of Tzield include lymphopenia (73% teplizumab vs. 6% placebo), rash (36% vs. 0%), leukopenia (221% vs. 0%), and headache (11% vs. 6%). Label warnings and precautions include monitoring for cytokine release syndrome, risk for serious infections, and avoidance of live, inactivated, and mRNA vaccines.

This approval is likely to accelerate discussion about universal autoantibody screening. Currently, most individuals identified as having preclinical type 1 diabetes are first-degree relatives of people with type 1 diabetes identified through the federally funded TrialNet program. In December 2020, the type 1 diabetes research and advocacy organization JDRF began offering a $55 home blood test to screen for the antibodies, and other screening programs have been launched in the United States and Europe.  

Previous studies have examined cost-effectiveness of universal screening in children and the optimal ages that such screening should take place.  

In October, Provention Bio announced a co-promotion agreement with Sanofi for the U.S. launch of Tzield for delay in onset of clinical T1D in at-risk individuals. Provention Bio offers financial assistance options (e.g., copay assistance) to eligible patients for out-of-pocket costs.

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

“Take it from me, parents just don’t understand.”

Fresh Prince and D.J. Jazzy Jeff penned this lyric roughly 35 years ago, and coincidentally the HIV/AIDS epidemic has also been with us just as long. But the connection between the two may be highly relevant – that is, if you consider how infrequently parents appear (or have the proper tools) to engage with their gay or bisexual sons to prevent and curb HIV infections.

The glaring disparities in new and undiagnosed cases in young men who have sex with men (YMSM) help highlight why novel strategies (such as greater parental involvement) are needed.

Currently, YMSM between the ages of 13 and 24 are among the most affected by the ongoing HIV epidemic, with CDC estimates suggesting that, in 2020, this group alone represented about 35% of new diagnoses. At the same time, about half of these HIV infections go undiagnosed. Recent data also suggest that care linkage in this group is similar to adults, but only a third of YMSM start antiretroviral therapy and are retained in care, leading to viral suppression rates as low as 12%.

With a goal to change these discouraging numbers, researchers from George Washington University, Washington, and other institutions conducted a randomized controlled pilot study targeting parents of YMSM to improve both the frequency and quality of communication around sexual health and HIV risk, prevention, and testing.

The findings, which were published online in the journal AIDS and Behavior, highlight the observation that parents could be an essential resource for combating the HIV epidemic, but they’re a resource that’s often underutilized. In fact, after participating in an online offering – PATHS (Parents and Adolescents Talking about Healthy Sexuality) – parents reported significantly greater engagement with their sons, especially around discussions focusing on HIV information and condom use.

“From what we know from the research, parents are uncomfortable talking about sex; they’re not great at talking about it. But when they do and do it effectively, those kids seem to have better health outcomes,” lead author David Huebner, PhD, MPH, associate professor of prevention and community health at George Washington University, said in an interview.

“The goal was to get parents to deliver more messages and engage in more behaviors with their sons that we think are likely to help their sons stay healthy,” he said.

For the pilot study, Huebner and his team recruited 61 parents (95% of whom were mothers) with predominantly high school-aged cisgender sons (median, 16.7-17 years) who had come out as gay or bisexual at least a month prior, whose HIV status was negative or unknown, and who were living at home.

The interventions were strictly parent focused, Dr. Huebner said, noting that the only interaction with the kids involved independent surveys at the start and end of the study that explored parental behavior and engagement.

For the study, parental participants were stratified by son’s age (13-17 or 18-22 years) and then randomly assigned to participate in a web-accessible PATHS intervention (intervention group) or view a 35-minute, documentary-style film that encouraged acceptance of lesbian, gay, or bisexual children (control group),

Parents assigned to the intervention group were asked to engage in their own time with six modules that explored the importance of communication, HIV information, using and acquiring condoms, HIV testing, and as follow-up, a “to-do” list encouraging selection of how they would follow up with their sons about the content. They were also offered the option to participate in supplemental modules on pre-exposure prophylaxis (PrEP), anal intercourse, and what to do if a child tested positive for HIV.

“The intervention ... showed strong evidence of being effective at changing the parent behaviors that we hoped to change,” Dr. Huebner explained.

“We got independent reports from parents and kids that showed the same thing: parents were more likely to communicate with their sons about HIV in the 3 months after the intervention and were more likely to help their sons get access to condoms,” he said.

Both of these findings were significant, with parents in the experimental group being almost 10 times more likely to share HIV information with their sons (odds ratio, 9.50; 95% confidence interval, 1.02-39.99; P < .05) and five times more likely to teach proper condom use (OR, 5.04; 95% CI 1.56-12.46; P < .05), compared with parents receiving the placebo.

“It’s very promising that the initial signals from their intervention do show that parents facilitating the acquisition of information for young men who have sex with men really works,” said Dalmacio Dennis Flores, PhD, ACRN, an assistant professor of nursing in family and community health at the University of Pennsylvania, Philadelphia. He was not directly involved in the study.

“On the outcomes that matter for us, such as HIV prevention or getting tested, they were able to document that parents receiving guidance on how to have these conversations does result in youth outcomes – something that has been lacking in the literature specifically for this population up until today,” Dr. Flores told this news organization.

Overall, parents engaging in the PATHS intervention showed improvements in skills, attitudes, and behavioral intention toward engagement with their sons, including assisting with HIV testing. However, what about parental involvement in these types of dialogues with children who have not yet come out to their parents?

Dr. Flores said that, although Dr. Huebner’s work is pivotal for families where the child’s sexual orientation is known to parents, there is value in inclusive sex communication for all youth, regardless of how they identify (that is, out of the closet, closeted, straight, or those who are questioning their identity), especially since younger generations of LGBTQ youth are coming out at earlier ages, compared with previous generations.

It’s not just parents. Clinicians also have critical roles to play in helping bridge the sex-talk communication gaps between parents and adolescents and young adult children.

“In my work, I’ve found that more clinicians are willing to broach this within the discussion with dyads, with parents and adolescents in the room,” said Dr. Flores.

And he added: “If clinicians signal that there’s no such thing as too early to have these conversations or that issues such as consent, safety, and sexting are all okay to talk about because these are the current realities of young people, then parents can feel that they’re empowered to broach or sustain these conversations.”

Importantly, Dr. Huebner and associates are currently recruiting larger numbers of families for a new, yearlong trial that will not only examine parental behavior changes but also whether these changes translate into improvements in their child’s sexual health and/or competency. Interested families can learn more about the study and sign up to receive updates at www.parentwithlove.org.

Dr. Huebner and Dr. Flores reported no relevant financial relationships.

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

“Take it from me, parents just don’t understand.”

Fresh Prince and D.J. Jazzy Jeff penned this lyric roughly 35 years ago, and coincidentally the HIV/AIDS epidemic has also been with us just as long. But the connection between the two may be highly relevant – that is, if you consider how infrequently parents appear (or have the proper tools) to engage with their gay or bisexual sons to prevent and curb HIV infections.

The glaring disparities in new and undiagnosed cases in young men who have sex with men (YMSM) help highlight why novel strategies (such as greater parental involvement) are needed.

Currently, YMSM between the ages of 13 and 24 are among the most affected by the ongoing HIV epidemic, with CDC estimates suggesting that, in 2020, this group alone represented about 35% of new diagnoses. At the same time, about half of these HIV infections go undiagnosed. Recent data also suggest that care linkage in this group is similar to adults, but only a third of YMSM start antiretroviral therapy and are retained in care, leading to viral suppression rates as low as 12%.

With a goal to change these discouraging numbers, researchers from George Washington University, Washington, and other institutions conducted a randomized controlled pilot study targeting parents of YMSM to improve both the frequency and quality of communication around sexual health and HIV risk, prevention, and testing.

The findings, which were published online in the journal AIDS and Behavior, highlight the observation that parents could be an essential resource for combating the HIV epidemic, but they’re a resource that’s often underutilized. In fact, after participating in an online offering – PATHS (Parents and Adolescents Talking about Healthy Sexuality) – parents reported significantly greater engagement with their sons, especially around discussions focusing on HIV information and condom use.

“From what we know from the research, parents are uncomfortable talking about sex; they’re not great at talking about it. But when they do and do it effectively, those kids seem to have better health outcomes,” lead author David Huebner, PhD, MPH, associate professor of prevention and community health at George Washington University, said in an interview.

“The goal was to get parents to deliver more messages and engage in more behaviors with their sons that we think are likely to help their sons stay healthy,” he said.

For the pilot study, Huebner and his team recruited 61 parents (95% of whom were mothers) with predominantly high school-aged cisgender sons (median, 16.7-17 years) who had come out as gay or bisexual at least a month prior, whose HIV status was negative or unknown, and who were living at home.

The interventions were strictly parent focused, Dr. Huebner said, noting that the only interaction with the kids involved independent surveys at the start and end of the study that explored parental behavior and engagement.

For the study, parental participants were stratified by son’s age (13-17 or 18-22 years) and then randomly assigned to participate in a web-accessible PATHS intervention (intervention group) or view a 35-minute, documentary-style film that encouraged acceptance of lesbian, gay, or bisexual children (control group),

Parents assigned to the intervention group were asked to engage in their own time with six modules that explored the importance of communication, HIV information, using and acquiring condoms, HIV testing, and as follow-up, a “to-do” list encouraging selection of how they would follow up with their sons about the content. They were also offered the option to participate in supplemental modules on pre-exposure prophylaxis (PrEP), anal intercourse, and what to do if a child tested positive for HIV.

“The intervention ... showed strong evidence of being effective at changing the parent behaviors that we hoped to change,” Dr. Huebner explained.

“We got independent reports from parents and kids that showed the same thing: parents were more likely to communicate with their sons about HIV in the 3 months after the intervention and were more likely to help their sons get access to condoms,” he said.

Both of these findings were significant, with parents in the experimental group being almost 10 times more likely to share HIV information with their sons (odds ratio, 9.50; 95% confidence interval, 1.02-39.99; P < .05) and five times more likely to teach proper condom use (OR, 5.04; 95% CI 1.56-12.46; P < .05), compared with parents receiving the placebo.

“It’s very promising that the initial signals from their intervention do show that parents facilitating the acquisition of information for young men who have sex with men really works,” said Dalmacio Dennis Flores, PhD, ACRN, an assistant professor of nursing in family and community health at the University of Pennsylvania, Philadelphia. He was not directly involved in the study.

“On the outcomes that matter for us, such as HIV prevention or getting tested, they were able to document that parents receiving guidance on how to have these conversations does result in youth outcomes – something that has been lacking in the literature specifically for this population up until today,” Dr. Flores told this news organization.

Overall, parents engaging in the PATHS intervention showed improvements in skills, attitudes, and behavioral intention toward engagement with their sons, including assisting with HIV testing. However, what about parental involvement in these types of dialogues with children who have not yet come out to their parents?

Dr. Flores said that, although Dr. Huebner’s work is pivotal for families where the child’s sexual orientation is known to parents, there is value in inclusive sex communication for all youth, regardless of how they identify (that is, out of the closet, closeted, straight, or those who are questioning their identity), especially since younger generations of LGBTQ youth are coming out at earlier ages, compared with previous generations.

It’s not just parents. Clinicians also have critical roles to play in helping bridge the sex-talk communication gaps between parents and adolescents and young adult children.

“In my work, I’ve found that more clinicians are willing to broach this within the discussion with dyads, with parents and adolescents in the room,” said Dr. Flores.

And he added: “If clinicians signal that there’s no such thing as too early to have these conversations or that issues such as consent, safety, and sexting are all okay to talk about because these are the current realities of young people, then parents can feel that they’re empowered to broach or sustain these conversations.”

Importantly, Dr. Huebner and associates are currently recruiting larger numbers of families for a new, yearlong trial that will not only examine parental behavior changes but also whether these changes translate into improvements in their child’s sexual health and/or competency. Interested families can learn more about the study and sign up to receive updates at www.parentwithlove.org.

Dr. Huebner and Dr. Flores reported no relevant financial relationships.

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

“Take it from me, parents just don’t understand.”

Fresh Prince and D.J. Jazzy Jeff penned this lyric roughly 35 years ago, and coincidentally the HIV/AIDS epidemic has also been with us just as long. But the connection between the two may be highly relevant – that is, if you consider how infrequently parents appear (or have the proper tools) to engage with their gay or bisexual sons to prevent and curb HIV infections.

The glaring disparities in new and undiagnosed cases in young men who have sex with men (YMSM) help highlight why novel strategies (such as greater parental involvement) are needed.

Currently, YMSM between the ages of 13 and 24 are among the most affected by the ongoing HIV epidemic, with CDC estimates suggesting that, in 2020, this group alone represented about 35% of new diagnoses. At the same time, about half of these HIV infections go undiagnosed. Recent data also suggest that care linkage in this group is similar to adults, but only a third of YMSM start antiretroviral therapy and are retained in care, leading to viral suppression rates as low as 12%.

With a goal to change these discouraging numbers, researchers from George Washington University, Washington, and other institutions conducted a randomized controlled pilot study targeting parents of YMSM to improve both the frequency and quality of communication around sexual health and HIV risk, prevention, and testing.

The findings, which were published online in the journal AIDS and Behavior, highlight the observation that parents could be an essential resource for combating the HIV epidemic, but they’re a resource that’s often underutilized. In fact, after participating in an online offering – PATHS (Parents and Adolescents Talking about Healthy Sexuality) – parents reported significantly greater engagement with their sons, especially around discussions focusing on HIV information and condom use.

“From what we know from the research, parents are uncomfortable talking about sex; they’re not great at talking about it. But when they do and do it effectively, those kids seem to have better health outcomes,” lead author David Huebner, PhD, MPH, associate professor of prevention and community health at George Washington University, said in an interview.

“The goal was to get parents to deliver more messages and engage in more behaviors with their sons that we think are likely to help their sons stay healthy,” he said.

For the pilot study, Huebner and his team recruited 61 parents (95% of whom were mothers) with predominantly high school-aged cisgender sons (median, 16.7-17 years) who had come out as gay or bisexual at least a month prior, whose HIV status was negative or unknown, and who were living at home.

The interventions were strictly parent focused, Dr. Huebner said, noting that the only interaction with the kids involved independent surveys at the start and end of the study that explored parental behavior and engagement.

For the study, parental participants were stratified by son’s age (13-17 or 18-22 years) and then randomly assigned to participate in a web-accessible PATHS intervention (intervention group) or view a 35-minute, documentary-style film that encouraged acceptance of lesbian, gay, or bisexual children (control group),

Parents assigned to the intervention group were asked to engage in their own time with six modules that explored the importance of communication, HIV information, using and acquiring condoms, HIV testing, and as follow-up, a “to-do” list encouraging selection of how they would follow up with their sons about the content. They were also offered the option to participate in supplemental modules on pre-exposure prophylaxis (PrEP), anal intercourse, and what to do if a child tested positive for HIV.

“The intervention ... showed strong evidence of being effective at changing the parent behaviors that we hoped to change,” Dr. Huebner explained.

“We got independent reports from parents and kids that showed the same thing: parents were more likely to communicate with their sons about HIV in the 3 months after the intervention and were more likely to help their sons get access to condoms,” he said.

Both of these findings were significant, with parents in the experimental group being almost 10 times more likely to share HIV information with their sons (odds ratio, 9.50; 95% confidence interval, 1.02-39.99; P < .05) and five times more likely to teach proper condom use (OR, 5.04; 95% CI 1.56-12.46; P < .05), compared with parents receiving the placebo.

“It’s very promising that the initial signals from their intervention do show that parents facilitating the acquisition of information for young men who have sex with men really works,” said Dalmacio Dennis Flores, PhD, ACRN, an assistant professor of nursing in family and community health at the University of Pennsylvania, Philadelphia. He was not directly involved in the study.

“On the outcomes that matter for us, such as HIV prevention or getting tested, they were able to document that parents receiving guidance on how to have these conversations does result in youth outcomes – something that has been lacking in the literature specifically for this population up until today,” Dr. Flores told this news organization.

Overall, parents engaging in the PATHS intervention showed improvements in skills, attitudes, and behavioral intention toward engagement with their sons, including assisting with HIV testing. However, what about parental involvement in these types of dialogues with children who have not yet come out to their parents?

Dr. Flores said that, although Dr. Huebner’s work is pivotal for families where the child’s sexual orientation is known to parents, there is value in inclusive sex communication for all youth, regardless of how they identify (that is, out of the closet, closeted, straight, or those who are questioning their identity), especially since younger generations of LGBTQ youth are coming out at earlier ages, compared with previous generations.

It’s not just parents. Clinicians also have critical roles to play in helping bridge the sex-talk communication gaps between parents and adolescents and young adult children.

“In my work, I’ve found that more clinicians are willing to broach this within the discussion with dyads, with parents and adolescents in the room,” said Dr. Flores.

And he added: “If clinicians signal that there’s no such thing as too early to have these conversations or that issues such as consent, safety, and sexting are all okay to talk about because these are the current realities of young people, then parents can feel that they’re empowered to broach or sustain these conversations.”

Importantly, Dr. Huebner and associates are currently recruiting larger numbers of families for a new, yearlong trial that will not only examine parental behavior changes but also whether these changes translate into improvements in their child’s sexual health and/or competency. Interested families can learn more about the study and sign up to receive updates at www.parentwithlove.org.

Dr. Huebner and Dr. Flores reported no relevant financial relationships.

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

Electrolyte abnormalities may serve as a precursor to a future eating disorder diagnosis, a finding that may help pinpoint candidates for screening.

Researchers found that adolescents and adults with electrolyte abnormalities on routine outpatient lab work were twice as likely as those without these disturbances to be subsequently diagnosed with an eating disorder.

“These electrolyte abnormalities were in fact seen well ahead (> 1 year on average) of the time when patients were diagnosed with eating disorders,” study investigator Gregory Hundemer, MD, department of nephrology, University of Ottawa, told this news organization.

“Incidentally discovered outpatient electrolyte abnormalities may help to identify individuals who may benefit from more targeted screening into an underlying eating disorder. This, in turn, may allow for earlier diagnosis and therapeutic intervention,” Dr. Hundemer said.

The study was published online in JAMA Network Open.
 

Tailored screening?

Electrolyte abnormalities are often found when an individual is diagnosed with an eating disorder, but it’s largely unknown whether electrolyte abnormalities prior to the acute presentation of an eating disorder are associated with the future diagnosis of an eating disorder.

To investigate, the researchers used administrative health data to match 6,970 individuals (mean age, 28 years; 13% male) with an eating disorder diagnosis to 27,878 controls without an eating disorder diagnosis.

They found that individuals with an eating disorder were more likely to have a preceding electrolyte abnormality, compared with peers without an eating disorder (18.4% vs. 7.5%).

An outpatient electrolyte abnormality present 3 years to 30 days prior to diagnosis was associated with about a twofold higher odds for subsequent eating disorder diagnosis (adjusted odds ratio, 2.12; 95% confidence interval, 1.86-2.41).

The median time from the earliest electrolyte abnormality to eating disorder diagnosis was 386 days (range, 157-716 days).

Hypokalemia was the most common electrolyte abnormality (present in 12% of cases vs. 5% of controls), while hyponatremia, hypernatremia, hypophosphatemia, and metabolic alkalosis were the most specific for a subsequent eating disorder diagnosis.

Severe hypokalemia (serum potassium levels of 3.0 mmol/L or lower) and severe hyponatremia (serum sodium, 128 mmol/L or lower) were associated with over sevenfold and fivefold higher odds for the diagnosis of an eating disorder, respectively.

The U.S. Preventive Services Task Force issued its first-ever statement on screening for eating disorders earlier this year.

The task force concluded that there is insufficient evidence to weigh the balance of benefits and harms of screening for eating disorders in adolescents and adults with no signs or symptoms of an eating disorder or concerns about their eating and who have not previously been diagnosed with an eating disorder.

Dr. Hundemer and colleagues believe an incidental electrolyte abnormality may identify candidates at high risk for an underlying eating disorder who many benefit from screening.

Several screening tools of varying complexity have been developed that are validated and accurate in identifying individuals with a potential eating disorder.

They include the SCOFF questionnaire, the Eating Disorder Screen for Primary Care, the Eating Attitudes Test, and the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire.
 

Underdiagnosed, undertreated

Offering perspective on the findings, Kamryn T. Eddy, PhD, codirector, Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, said the notion “that a physical sign may help to promote eating disorder assessment is important particularly given that early detection can improve outcomes.”

“But this finding appears in the current context of eating disorders going largely underdetected, underdiagnosed, and undertreated across medical and psychiatric settings,” said Dr. Eddy, associate professor, department of psychiatry, Harvard Medical School, Boston.

“Indeed, eating disorders are prevalent and cut across age, sex, gender, weight, race, ethnicity, and socioeconomic strata, and still, many providers do not routinely assess for eating disorders,” Dr. Eddy said.

“I might suggest that perhaps in addition to letting electrolyte abnormalities be a cue to screen for eating disorders, an even more powerful shift toward routine screening and assessment of eating disorders by medical providers be made,” Dr. Eddy said in an interview.

This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Health and Long-Term Care. Dr. Hundemer and Dr. Eddy have disclosed no relevant financial relationships.

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

Electrolyte abnormalities may serve as a precursor to a future eating disorder diagnosis, a finding that may help pinpoint candidates for screening.

Researchers found that adolescents and adults with electrolyte abnormalities on routine outpatient lab work were twice as likely as those without these disturbances to be subsequently diagnosed with an eating disorder.

“These electrolyte abnormalities were in fact seen well ahead (> 1 year on average) of the time when patients were diagnosed with eating disorders,” study investigator Gregory Hundemer, MD, department of nephrology, University of Ottawa, told this news organization.

“Incidentally discovered outpatient electrolyte abnormalities may help to identify individuals who may benefit from more targeted screening into an underlying eating disorder. This, in turn, may allow for earlier diagnosis and therapeutic intervention,” Dr. Hundemer said.

The study was published online in JAMA Network Open.
 

Tailored screening?

Electrolyte abnormalities are often found when an individual is diagnosed with an eating disorder, but it’s largely unknown whether electrolyte abnormalities prior to the acute presentation of an eating disorder are associated with the future diagnosis of an eating disorder.

To investigate, the researchers used administrative health data to match 6,970 individuals (mean age, 28 years; 13% male) with an eating disorder diagnosis to 27,878 controls without an eating disorder diagnosis.

They found that individuals with an eating disorder were more likely to have a preceding electrolyte abnormality, compared with peers without an eating disorder (18.4% vs. 7.5%).

An outpatient electrolyte abnormality present 3 years to 30 days prior to diagnosis was associated with about a twofold higher odds for subsequent eating disorder diagnosis (adjusted odds ratio, 2.12; 95% confidence interval, 1.86-2.41).

The median time from the earliest electrolyte abnormality to eating disorder diagnosis was 386 days (range, 157-716 days).

Hypokalemia was the most common electrolyte abnormality (present in 12% of cases vs. 5% of controls), while hyponatremia, hypernatremia, hypophosphatemia, and metabolic alkalosis were the most specific for a subsequent eating disorder diagnosis.

Severe hypokalemia (serum potassium levels of 3.0 mmol/L or lower) and severe hyponatremia (serum sodium, 128 mmol/L or lower) were associated with over sevenfold and fivefold higher odds for the diagnosis of an eating disorder, respectively.

The U.S. Preventive Services Task Force issued its first-ever statement on screening for eating disorders earlier this year.

The task force concluded that there is insufficient evidence to weigh the balance of benefits and harms of screening for eating disorders in adolescents and adults with no signs or symptoms of an eating disorder or concerns about their eating and who have not previously been diagnosed with an eating disorder.

Dr. Hundemer and colleagues believe an incidental electrolyte abnormality may identify candidates at high risk for an underlying eating disorder who many benefit from screening.

Several screening tools of varying complexity have been developed that are validated and accurate in identifying individuals with a potential eating disorder.

They include the SCOFF questionnaire, the Eating Disorder Screen for Primary Care, the Eating Attitudes Test, and the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire.
 

Underdiagnosed, undertreated

Offering perspective on the findings, Kamryn T. Eddy, PhD, codirector, Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, said the notion “that a physical sign may help to promote eating disorder assessment is important particularly given that early detection can improve outcomes.”

“But this finding appears in the current context of eating disorders going largely underdetected, underdiagnosed, and undertreated across medical and psychiatric settings,” said Dr. Eddy, associate professor, department of psychiatry, Harvard Medical School, Boston.

“Indeed, eating disorders are prevalent and cut across age, sex, gender, weight, race, ethnicity, and socioeconomic strata, and still, many providers do not routinely assess for eating disorders,” Dr. Eddy said.

“I might suggest that perhaps in addition to letting electrolyte abnormalities be a cue to screen for eating disorders, an even more powerful shift toward routine screening and assessment of eating disorders by medical providers be made,” Dr. Eddy said in an interview.

This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Health and Long-Term Care. Dr. Hundemer and Dr. Eddy have disclosed no relevant financial relationships.

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

Electrolyte abnormalities may serve as a precursor to a future eating disorder diagnosis, a finding that may help pinpoint candidates for screening.

Researchers found that adolescents and adults with electrolyte abnormalities on routine outpatient lab work were twice as likely as those without these disturbances to be subsequently diagnosed with an eating disorder.

“These electrolyte abnormalities were in fact seen well ahead (> 1 year on average) of the time when patients were diagnosed with eating disorders,” study investigator Gregory Hundemer, MD, department of nephrology, University of Ottawa, told this news organization.

“Incidentally discovered outpatient electrolyte abnormalities may help to identify individuals who may benefit from more targeted screening into an underlying eating disorder. This, in turn, may allow for earlier diagnosis and therapeutic intervention,” Dr. Hundemer said.

The study was published online in JAMA Network Open.
 

Tailored screening?

Electrolyte abnormalities are often found when an individual is diagnosed with an eating disorder, but it’s largely unknown whether electrolyte abnormalities prior to the acute presentation of an eating disorder are associated with the future diagnosis of an eating disorder.

To investigate, the researchers used administrative health data to match 6,970 individuals (mean age, 28 years; 13% male) with an eating disorder diagnosis to 27,878 controls without an eating disorder diagnosis.

They found that individuals with an eating disorder were more likely to have a preceding electrolyte abnormality, compared with peers without an eating disorder (18.4% vs. 7.5%).

An outpatient electrolyte abnormality present 3 years to 30 days prior to diagnosis was associated with about a twofold higher odds for subsequent eating disorder diagnosis (adjusted odds ratio, 2.12; 95% confidence interval, 1.86-2.41).

The median time from the earliest electrolyte abnormality to eating disorder diagnosis was 386 days (range, 157-716 days).

Hypokalemia was the most common electrolyte abnormality (present in 12% of cases vs. 5% of controls), while hyponatremia, hypernatremia, hypophosphatemia, and metabolic alkalosis were the most specific for a subsequent eating disorder diagnosis.

Severe hypokalemia (serum potassium levels of 3.0 mmol/L or lower) and severe hyponatremia (serum sodium, 128 mmol/L or lower) were associated with over sevenfold and fivefold higher odds for the diagnosis of an eating disorder, respectively.

The U.S. Preventive Services Task Force issued its first-ever statement on screening for eating disorders earlier this year.

The task force concluded that there is insufficient evidence to weigh the balance of benefits and harms of screening for eating disorders in adolescents and adults with no signs or symptoms of an eating disorder or concerns about their eating and who have not previously been diagnosed with an eating disorder.

Dr. Hundemer and colleagues believe an incidental electrolyte abnormality may identify candidates at high risk for an underlying eating disorder who many benefit from screening.

Several screening tools of varying complexity have been developed that are validated and accurate in identifying individuals with a potential eating disorder.

They include the SCOFF questionnaire, the Eating Disorder Screen for Primary Care, the Eating Attitudes Test, and the Primary Care Evaluation of Mental Disorders Patient Health Questionnaire.
 

Underdiagnosed, undertreated

Offering perspective on the findings, Kamryn T. Eddy, PhD, codirector, Eating Disorders Clinical and Research Program, Massachusetts General Hospital, Boston, said the notion “that a physical sign may help to promote eating disorder assessment is important particularly given that early detection can improve outcomes.”

“But this finding appears in the current context of eating disorders going largely underdetected, underdiagnosed, and undertreated across medical and psychiatric settings,” said Dr. Eddy, associate professor, department of psychiatry, Harvard Medical School, Boston.

“Indeed, eating disorders are prevalent and cut across age, sex, gender, weight, race, ethnicity, and socioeconomic strata, and still, many providers do not routinely assess for eating disorders,” Dr. Eddy said.

“I might suggest that perhaps in addition to letting electrolyte abnormalities be a cue to screen for eating disorders, an even more powerful shift toward routine screening and assessment of eating disorders by medical providers be made,” Dr. Eddy said in an interview.

This study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Health and Long-Term Care. Dr. Hundemer and Dr. Eddy have disclosed no relevant financial relationships.

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

The Food and Drug Administration has expanded the indication for tenofovir alafenamide (Vemlidy) to children aged 12 years and older with chronic hepatitis B virus (HBV) infection with compensated liver disease, the drug’s manufacturer has announced.

The approval in the pediatric patient population was supported by 24-week data from a phase 2 clinical trial comparing treatment with tenofovir alafenamide (25 mg once daily) with placebo in 70 treatment-naive and treatment-experienced patients aged 12-18 years weighing at least 35 kg.

The study met its primary endpoint of percentage of patients with HBV DNA levels less than 20 IU/mL at 24 weeks of therapy, Gilead Sciences said in a press release.

Overall, 10 of 47 (21%) patients treated with tenofovir alafenamide achieved HBV DNA less than 20 IU/mL at 24 weeks, compared with 0 of 23 (0%) treated with placebo.

The rates of serum ALT normalization were higher with tenofovir alafenamide than with placebo (44% vs 0%).

The mean percent changes in bone mineral density (BMD) from baseline to 24 weeks were numerically similar for tenofovir alafenamide– and placebo-treated patients (2.4% and 1.9% for lumbar spine, and 1.5% and 1.9% for whole body, respectively).

The mean changes from baseline BMD z scores were –0.03 and –0.09 for lumbar spine, and –0.05 and –0.01 for whole body, for tenofovir alafenamide and placebo groups, respectively.

The FDA initially approved the nucleoside analog reverse transcriptase inhibitor in 2016 for adults with chronic HBV.

The drug was approved in Europe in 2017 for chronic HBV infection in adults and adolescents aged 12 years and older weighing at least 35 kg.

Tenofovir alafenamide carries a boxed warning citing risks for lactic acidosis/severe hepatomegaly with steatosis and posttreatment severe acute exacerbation of HBV.

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

The Food and Drug Administration has expanded the indication for tenofovir alafenamide (Vemlidy) to children aged 12 years and older with chronic hepatitis B virus (HBV) infection with compensated liver disease, the drug’s manufacturer has announced.

The approval in the pediatric patient population was supported by 24-week data from a phase 2 clinical trial comparing treatment with tenofovir alafenamide (25 mg once daily) with placebo in 70 treatment-naive and treatment-experienced patients aged 12-18 years weighing at least 35 kg.

The study met its primary endpoint of percentage of patients with HBV DNA levels less than 20 IU/mL at 24 weeks of therapy, Gilead Sciences said in a press release.

Overall, 10 of 47 (21%) patients treated with tenofovir alafenamide achieved HBV DNA less than 20 IU/mL at 24 weeks, compared with 0 of 23 (0%) treated with placebo.

The rates of serum ALT normalization were higher with tenofovir alafenamide than with placebo (44% vs 0%).

The mean percent changes in bone mineral density (BMD) from baseline to 24 weeks were numerically similar for tenofovir alafenamide– and placebo-treated patients (2.4% and 1.9% for lumbar spine, and 1.5% and 1.9% for whole body, respectively).

The mean changes from baseline BMD z scores were –0.03 and –0.09 for lumbar spine, and –0.05 and –0.01 for whole body, for tenofovir alafenamide and placebo groups, respectively.

The FDA initially approved the nucleoside analog reverse transcriptase inhibitor in 2016 for adults with chronic HBV.

The drug was approved in Europe in 2017 for chronic HBV infection in adults and adolescents aged 12 years and older weighing at least 35 kg.

Tenofovir alafenamide carries a boxed warning citing risks for lactic acidosis/severe hepatomegaly with steatosis and posttreatment severe acute exacerbation of HBV.

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

The Food and Drug Administration has expanded the indication for tenofovir alafenamide (Vemlidy) to children aged 12 years and older with chronic hepatitis B virus (HBV) infection with compensated liver disease, the drug’s manufacturer has announced.

The approval in the pediatric patient population was supported by 24-week data from a phase 2 clinical trial comparing treatment with tenofovir alafenamide (25 mg once daily) with placebo in 70 treatment-naive and treatment-experienced patients aged 12-18 years weighing at least 35 kg.

The study met its primary endpoint of percentage of patients with HBV DNA levels less than 20 IU/mL at 24 weeks of therapy, Gilead Sciences said in a press release.

Overall, 10 of 47 (21%) patients treated with tenofovir alafenamide achieved HBV DNA less than 20 IU/mL at 24 weeks, compared with 0 of 23 (0%) treated with placebo.

The rates of serum ALT normalization were higher with tenofovir alafenamide than with placebo (44% vs 0%).

The mean percent changes in bone mineral density (BMD) from baseline to 24 weeks were numerically similar for tenofovir alafenamide– and placebo-treated patients (2.4% and 1.9% for lumbar spine, and 1.5% and 1.9% for whole body, respectively).

The mean changes from baseline BMD z scores were –0.03 and –0.09 for lumbar spine, and –0.05 and –0.01 for whole body, for tenofovir alafenamide and placebo groups, respectively.

The FDA initially approved the nucleoside analog reverse transcriptase inhibitor in 2016 for adults with chronic HBV.

The drug was approved in Europe in 2017 for chronic HBV infection in adults and adolescents aged 12 years and older weighing at least 35 kg.

Tenofovir alafenamide carries a boxed warning citing risks for lactic acidosis/severe hepatomegaly with steatosis and posttreatment severe acute exacerbation of HBV.

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

LAS VEGAS – Acne is a barrier-deficient disorder, and good skin care with over-the-counter products can improve this barrier and increase adherence to prescription medications, Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical Center, New Brunswick, N.J., said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar.

In some cases, the use of good-quality over-the -counter skin care products can improve acne without prescription treatment, said Dr. Baldwin, who is medical director of the Acne Treatment and Research Center, New York. Good skin care can enhance the effects of prescription medication by decreasing side effects such as inflammation, pain, and erythema, and improving compliance; and use of OTC products has not been shown to interfere with the efficacy of prescription products, she noted.

However, patient education about OTC products is key, she said. In particular, “cleansers are a double-edged sword,” Dr. Baldwin emphasized.

Cleansing is important to preserve barrier function, but “there is a risk of skin damage” if cleansers are too harsh, she said. The goal is to remove dirt, oils, and bacteria without disrupting the lipids, proteins, and normal flora that keep skin healthy, and to avoid altering pH, she added.

Key considerations for OTC cleansers include surfactants, pH, and patient preferences, Dr. Baldwin said.

Surfactants, the main components of OTC cleansers, can do more harm than good in some cases. Surfactants break down impurities on the skin surface, but not all are created equal, and some may cause skin irritation, she explained.

Surfactants fall into four categories: nonionic (no charge), anionic (negative charge), cationic (positive charge), and amphoteric (dual charge). Of these, cationic surfactants have the highest level of antimicrobial activity.

Many patients with acne seek out antibacterial cleansers, but many of these products have a high pH, which can inhibit healthy skin function and promote inflammation, Dr. Baldwin noted.

The right OTC skin care products can normalize pH, which promotes repair of the skin barrier and reduces inflammation, she said. While some products are labeled as “gentle,” they may have a high pH, and many products don’t list a pH, Dr. Baldwin pointed out. Many antibacterial products have pH levels in the 10-12 range, while true soaps fall in the 9-10 range, and hydrating liquid cleansers often land in the 5-7 range, she said.

“Most of our patients don’t know what ingredients to look for” in a cleanser, she noted. However, data show that a majority of patients prefer a foaming cleanser, enjoy the face-washing experience – and wash their faces at least twice a day, with a range of products including bath soap, said Dr. Baldwin. Consequently, “educate your patient about moisturizing,” she advised.

For patients with greasy or oily skin, Dr. Baldwin recommends lipid-free foaming cleansers, such as those with ceramides or glycerin. For patients with dry, irritated acne, she advises once-daily washing only, without cleansing devices, which includes washcloths, she said. Look for hydrating cleansers that are nonfoaming or slightly foaming for these patients, she added.

Another tip for patients is to remind them that “sebum is not a moisturizer,” said Dr. Baldwin. Acne patients may still need moisturizers, especially if they experience dry skin as a side effect of their acne medication, but finding the right fit can be a challenge requiring some trial and error, she noted.

OTC products for rosacea

Dr. Baldwin also addressed the use of OTC products for patients with rosacea. For cleansers, she recommends the same hydrating, nonfoaming categories as for her acne patients, with a once-daily, no-device regimen. She advises rosacea patients to avoid pure humectants for moisturizing and noted that silicone-based products are often the least irritating.

Seek moisturizers with ceramides, hyaluronic acid, glycerin, or niacinamide, she said. Data have shown that effective moisturization improves the ability of patients with rosacea to use and adhere to their prescription medications, Dr. Baldwin emphasized. Moisturizers also can make the medication more effective by enhancing the penetration of products such as azelaic acid, she added.

No acne or rosacea visit is complete until overall skin care has been discussed, Dr. Baldwin said.

Dr. Baldwin disclosed serving as a consultant or adviser for Almirall, EPI Health, Galderma, La Roche Posay, Ortho Dermatologics, Sun, and Vyne; and serving as a speaker or member of the speakers’ bureau for Almirall, Galderma, La Roche Posay, Ortho Dermatologics, and Sun. MedscapeLive and this news organization are owned by the same parent company.

LAS VEGAS – Acne is a barrier-deficient disorder, and good skin care with over-the-counter products can improve this barrier and increase adherence to prescription medications, Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical Center, New Brunswick, N.J., said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar.

In some cases, the use of good-quality over-the -counter skin care products can improve acne without prescription treatment, said Dr. Baldwin, who is medical director of the Acne Treatment and Research Center, New York. Good skin care can enhance the effects of prescription medication by decreasing side effects such as inflammation, pain, and erythema, and improving compliance; and use of OTC products has not been shown to interfere with the efficacy of prescription products, she noted.

However, patient education about OTC products is key, she said. In particular, “cleansers are a double-edged sword,” Dr. Baldwin emphasized.

Cleansing is important to preserve barrier function, but “there is a risk of skin damage” if cleansers are too harsh, she said. The goal is to remove dirt, oils, and bacteria without disrupting the lipids, proteins, and normal flora that keep skin healthy, and to avoid altering pH, she added.

Key considerations for OTC cleansers include surfactants, pH, and patient preferences, Dr. Baldwin said.

Surfactants, the main components of OTC cleansers, can do more harm than good in some cases. Surfactants break down impurities on the skin surface, but not all are created equal, and some may cause skin irritation, she explained.

Surfactants fall into four categories: nonionic (no charge), anionic (negative charge), cationic (positive charge), and amphoteric (dual charge). Of these, cationic surfactants have the highest level of antimicrobial activity.

Many patients with acne seek out antibacterial cleansers, but many of these products have a high pH, which can inhibit healthy skin function and promote inflammation, Dr. Baldwin noted.

The right OTC skin care products can normalize pH, which promotes repair of the skin barrier and reduces inflammation, she said. While some products are labeled as “gentle,” they may have a high pH, and many products don’t list a pH, Dr. Baldwin pointed out. Many antibacterial products have pH levels in the 10-12 range, while true soaps fall in the 9-10 range, and hydrating liquid cleansers often land in the 5-7 range, she said.

“Most of our patients don’t know what ingredients to look for” in a cleanser, she noted. However, data show that a majority of patients prefer a foaming cleanser, enjoy the face-washing experience – and wash their faces at least twice a day, with a range of products including bath soap, said Dr. Baldwin. Consequently, “educate your patient about moisturizing,” she advised.

For patients with greasy or oily skin, Dr. Baldwin recommends lipid-free foaming cleansers, such as those with ceramides or glycerin. For patients with dry, irritated acne, she advises once-daily washing only, without cleansing devices, which includes washcloths, she said. Look for hydrating cleansers that are nonfoaming or slightly foaming for these patients, she added.

Another tip for patients is to remind them that “sebum is not a moisturizer,” said Dr. Baldwin. Acne patients may still need moisturizers, especially if they experience dry skin as a side effect of their acne medication, but finding the right fit can be a challenge requiring some trial and error, she noted.

OTC products for rosacea

Dr. Baldwin also addressed the use of OTC products for patients with rosacea. For cleansers, she recommends the same hydrating, nonfoaming categories as for her acne patients, with a once-daily, no-device regimen. She advises rosacea patients to avoid pure humectants for moisturizing and noted that silicone-based products are often the least irritating.

Seek moisturizers with ceramides, hyaluronic acid, glycerin, or niacinamide, she said. Data have shown that effective moisturization improves the ability of patients with rosacea to use and adhere to their prescription medications, Dr. Baldwin emphasized. Moisturizers also can make the medication more effective by enhancing the penetration of products such as azelaic acid, she added.

No acne or rosacea visit is complete until overall skin care has been discussed, Dr. Baldwin said.

Dr. Baldwin disclosed serving as a consultant or adviser for Almirall, EPI Health, Galderma, La Roche Posay, Ortho Dermatologics, Sun, and Vyne; and serving as a speaker or member of the speakers’ bureau for Almirall, Galderma, La Roche Posay, Ortho Dermatologics, and Sun. MedscapeLive and this news organization are owned by the same parent company.

LAS VEGAS – Acne is a barrier-deficient disorder, and good skin care with over-the-counter products can improve this barrier and increase adherence to prescription medications, Hilary E. Baldwin, MD, of Rutgers Robert Wood Johnson Medical Center, New Brunswick, N.J., said in a presentation at Medscape Live’s annual Las Vegas Dermatology Seminar.

In some cases, the use of good-quality over-the -counter skin care products can improve acne without prescription treatment, said Dr. Baldwin, who is medical director of the Acne Treatment and Research Center, New York. Good skin care can enhance the effects of prescription medication by decreasing side effects such as inflammation, pain, and erythema, and improving compliance; and use of OTC products has not been shown to interfere with the efficacy of prescription products, she noted.

However, patient education about OTC products is key, she said. In particular, “cleansers are a double-edged sword,” Dr. Baldwin emphasized.

Cleansing is important to preserve barrier function, but “there is a risk of skin damage” if cleansers are too harsh, she said. The goal is to remove dirt, oils, and bacteria without disrupting the lipids, proteins, and normal flora that keep skin healthy, and to avoid altering pH, she added.

Key considerations for OTC cleansers include surfactants, pH, and patient preferences, Dr. Baldwin said.

Surfactants, the main components of OTC cleansers, can do more harm than good in some cases. Surfactants break down impurities on the skin surface, but not all are created equal, and some may cause skin irritation, she explained.

Surfactants fall into four categories: nonionic (no charge), anionic (negative charge), cationic (positive charge), and amphoteric (dual charge). Of these, cationic surfactants have the highest level of antimicrobial activity.

Many patients with acne seek out antibacterial cleansers, but many of these products have a high pH, which can inhibit healthy skin function and promote inflammation, Dr. Baldwin noted.

The right OTC skin care products can normalize pH, which promotes repair of the skin barrier and reduces inflammation, she said. While some products are labeled as “gentle,” they may have a high pH, and many products don’t list a pH, Dr. Baldwin pointed out. Many antibacterial products have pH levels in the 10-12 range, while true soaps fall in the 9-10 range, and hydrating liquid cleansers often land in the 5-7 range, she said.

“Most of our patients don’t know what ingredients to look for” in a cleanser, she noted. However, data show that a majority of patients prefer a foaming cleanser, enjoy the face-washing experience – and wash their faces at least twice a day, with a range of products including bath soap, said Dr. Baldwin. Consequently, “educate your patient about moisturizing,” she advised.

For patients with greasy or oily skin, Dr. Baldwin recommends lipid-free foaming cleansers, such as those with ceramides or glycerin. For patients with dry, irritated acne, she advises once-daily washing only, without cleansing devices, which includes washcloths, she said. Look for hydrating cleansers that are nonfoaming or slightly foaming for these patients, she added.

Another tip for patients is to remind them that “sebum is not a moisturizer,” said Dr. Baldwin. Acne patients may still need moisturizers, especially if they experience dry skin as a side effect of their acne medication, but finding the right fit can be a challenge requiring some trial and error, she noted.

OTC products for rosacea

Dr. Baldwin also addressed the use of OTC products for patients with rosacea. For cleansers, she recommends the same hydrating, nonfoaming categories as for her acne patients, with a once-daily, no-device regimen. She advises rosacea patients to avoid pure humectants for moisturizing and noted that silicone-based products are often the least irritating.

Seek moisturizers with ceramides, hyaluronic acid, glycerin, or niacinamide, she said. Data have shown that effective moisturization improves the ability of patients with rosacea to use and adhere to their prescription medications, Dr. Baldwin emphasized. Moisturizers also can make the medication more effective by enhancing the penetration of products such as azelaic acid, she added.

No acne or rosacea visit is complete until overall skin care has been discussed, Dr. Baldwin said.

Dr. Baldwin disclosed serving as a consultant or adviser for Almirall, EPI Health, Galderma, La Roche Posay, Ortho Dermatologics, Sun, and Vyne; and serving as a speaker or member of the speakers’ bureau for Almirall, Galderma, La Roche Posay, Ortho Dermatologics, and Sun. MedscapeLive and this news organization are owned by the same parent company.

Vaping has become the dominant form of tobacco use by adolescents in the United States immediately after waking up, according to an analysis of a survey on teen tobacco use published in JAMA Network Open.

By 2019, Stanton Glantz, PhD, and associates found, “more e-cigarette users were using their first tobacco product within 5 minutes of waking than users of cigarettes and all other tobacco products combined.” Use upon waking is an indicator of addiction.

That number changed drastically from 2014 when less than 1% of sole-e-cigarette users were using e-cigarettes first thing in the morning to 10.3% by 2021. The numbers did not change for sole cigarette smokers or sole smokeless tobacco users, but did increase by half (odds ratio per year, 1.49) for sole cigar users.

In addition, among adolescents who currently use any tobacco product, the proportion whose first tobacco product was e-cigarettes increased from 27.2% in 2014 to 78.3% in 2019 and remained close to that at 77% in 2021.

Meanwhile, the number of young people using e-cigarettes peaked in 2019 and has been declining.

By 2019, the Centers for Disease Control and Prevention estimated that 5.3 million middle and high school students were using e-cigarettes. That number dropped to 3.6 million in 2020 and to 2.1 million in 2021 during the COVID-19 pandemic.
 

Researchers suspect more addictive nicotine

This increasing intensity of use may reflect the higher nicotine delivery and addiction liability of modern e-cigarettes that use protonated nicotine, which makes nicotine easier to inhale than older versions of e-cigarettes, which used freebase nicotine, Dr. Glantz and associates wrote.

The change in nicotine came in 2015 with the introduction of Juul products, they said, “which added benzoic acid to the nicotine e-liquid to lower the pH level and form protonated nicotine.”

The researchers advised: “Clinicians should question all their patients about nicotine and tobacco product use, including e-cigarettes and other new nicotine products.”

Raghu Appasani, MD, a psychiatrist who specializes in adolescent addiction and a clinical fellow at University of California, San Francisco, said in an interview that users often misunderstand the potential health effects of e-cigarettes and mistakenly think of them as a safe alternative to cigarettes.

All medical providers have a responsibility to ask patients about nicotine and tobacco products, Dr. Appasani said.
 

‘Be curious, not judgmental’

Dr. Appasani advised: “Be curious with your approach. This may uncover that maybe they use [e-cigarettes] to fit into a social scene or have stressors at home or in school. Most likely there is an underlying issue that has led to their use. Perhaps there is untreated anxiety and/or depression. Be curious, not judgmental.”

It is also important to ask about social and psychological factors that may be contributing to use and help the user think through how the use is affecting life in their home, school, and social settings, Dr. Appasani said.

He said he was not surprised by the findings as e-cigarettes allow easy access to smoking and it’s easier to hide the habit. The flavoring often get kids hooked originally.

The authors wrote: “These findings suggest that clinicians need to be ready to address youth addiction to these new highly addictive nicotine products during many clinical encounters, and stronger regulation is needed, including comprehensive bans on the sale of flavored tobacco products.”

Just more than half of the survey respondents (51.1%) were male and average age was 14. Researchers analyzed data from the National Youth Tobacco Survey, a nationally representative survey of middle and high school students.

They used the Youth Behavioral Risk Factor Surveillance System from 2015 to 2019 as a confirmatory analysis.

This study was supported in part by grants from the National Cancer Institute. Dr. Glantz received personal fees from the World Health Organization outside the submitted work. One coauthor reported serving as a paid expert witness against the tobacco industry outside the submitted work. No other disclosures were reported. Dr. Appasani declared no relevant financial relationships.

Vaping has become the dominant form of tobacco use by adolescents in the United States immediately after waking up, according to an analysis of a survey on teen tobacco use published in JAMA Network Open.

By 2019, Stanton Glantz, PhD, and associates found, “more e-cigarette users were using their first tobacco product within 5 minutes of waking than users of cigarettes and all other tobacco products combined.” Use upon waking is an indicator of addiction.

That number changed drastically from 2014 when less than 1% of sole-e-cigarette users were using e-cigarettes first thing in the morning to 10.3% by 2021. The numbers did not change for sole cigarette smokers or sole smokeless tobacco users, but did increase by half (odds ratio per year, 1.49) for sole cigar users.

In addition, among adolescents who currently use any tobacco product, the proportion whose first tobacco product was e-cigarettes increased from 27.2% in 2014 to 78.3% in 2019 and remained close to that at 77% in 2021.

Meanwhile, the number of young people using e-cigarettes peaked in 2019 and has been declining.

By 2019, the Centers for Disease Control and Prevention estimated that 5.3 million middle and high school students were using e-cigarettes. That number dropped to 3.6 million in 2020 and to 2.1 million in 2021 during the COVID-19 pandemic.
 

Researchers suspect more addictive nicotine

This increasing intensity of use may reflect the higher nicotine delivery and addiction liability of modern e-cigarettes that use protonated nicotine, which makes nicotine easier to inhale than older versions of e-cigarettes, which used freebase nicotine, Dr. Glantz and associates wrote.

The change in nicotine came in 2015 with the introduction of Juul products, they said, “which added benzoic acid to the nicotine e-liquid to lower the pH level and form protonated nicotine.”

The researchers advised: “Clinicians should question all their patients about nicotine and tobacco product use, including e-cigarettes and other new nicotine products.”

Raghu Appasani, MD, a psychiatrist who specializes in adolescent addiction and a clinical fellow at University of California, San Francisco, said in an interview that users often misunderstand the potential health effects of e-cigarettes and mistakenly think of them as a safe alternative to cigarettes.

All medical providers have a responsibility to ask patients about nicotine and tobacco products, Dr. Appasani said.
 

‘Be curious, not judgmental’

Dr. Appasani advised: “Be curious with your approach. This may uncover that maybe they use [e-cigarettes] to fit into a social scene or have stressors at home or in school. Most likely there is an underlying issue that has led to their use. Perhaps there is untreated anxiety and/or depression. Be curious, not judgmental.”

It is also important to ask about social and psychological factors that may be contributing to use and help the user think through how the use is affecting life in their home, school, and social settings, Dr. Appasani said.

He said he was not surprised by the findings as e-cigarettes allow easy access to smoking and it’s easier to hide the habit. The flavoring often get kids hooked originally.

The authors wrote: “These findings suggest that clinicians need to be ready to address youth addiction to these new highly addictive nicotine products during many clinical encounters, and stronger regulation is needed, including comprehensive bans on the sale of flavored tobacco products.”

Just more than half of the survey respondents (51.1%) were male and average age was 14. Researchers analyzed data from the National Youth Tobacco Survey, a nationally representative survey of middle and high school students.

They used the Youth Behavioral Risk Factor Surveillance System from 2015 to 2019 as a confirmatory analysis.

This study was supported in part by grants from the National Cancer Institute. Dr. Glantz received personal fees from the World Health Organization outside the submitted work. One coauthor reported serving as a paid expert witness against the tobacco industry outside the submitted work. No other disclosures were reported. Dr. Appasani declared no relevant financial relationships.

Vaping has become the dominant form of tobacco use by adolescents in the United States immediately after waking up, according to an analysis of a survey on teen tobacco use published in JAMA Network Open.

By 2019, Stanton Glantz, PhD, and associates found, “more e-cigarette users were using their first tobacco product within 5 minutes of waking than users of cigarettes and all other tobacco products combined.” Use upon waking is an indicator of addiction.

That number changed drastically from 2014 when less than 1% of sole-e-cigarette users were using e-cigarettes first thing in the morning to 10.3% by 2021. The numbers did not change for sole cigarette smokers or sole smokeless tobacco users, but did increase by half (odds ratio per year, 1.49) for sole cigar users.

In addition, among adolescents who currently use any tobacco product, the proportion whose first tobacco product was e-cigarettes increased from 27.2% in 2014 to 78.3% in 2019 and remained close to that at 77% in 2021.

Meanwhile, the number of young people using e-cigarettes peaked in 2019 and has been declining.

By 2019, the Centers for Disease Control and Prevention estimated that 5.3 million middle and high school students were using e-cigarettes. That number dropped to 3.6 million in 2020 and to 2.1 million in 2021 during the COVID-19 pandemic.
 

Researchers suspect more addictive nicotine

This increasing intensity of use may reflect the higher nicotine delivery and addiction liability of modern e-cigarettes that use protonated nicotine, which makes nicotine easier to inhale than older versions of e-cigarettes, which used freebase nicotine, Dr. Glantz and associates wrote.

The change in nicotine came in 2015 with the introduction of Juul products, they said, “which added benzoic acid to the nicotine e-liquid to lower the pH level and form protonated nicotine.”

The researchers advised: “Clinicians should question all their patients about nicotine and tobacco product use, including e-cigarettes and other new nicotine products.”

Raghu Appasani, MD, a psychiatrist who specializes in adolescent addiction and a clinical fellow at University of California, San Francisco, said in an interview that users often misunderstand the potential health effects of e-cigarettes and mistakenly think of them as a safe alternative to cigarettes.

All medical providers have a responsibility to ask patients about nicotine and tobacco products, Dr. Appasani said.
 

‘Be curious, not judgmental’

Dr. Appasani advised: “Be curious with your approach. This may uncover that maybe they use [e-cigarettes] to fit into a social scene or have stressors at home or in school. Most likely there is an underlying issue that has led to their use. Perhaps there is untreated anxiety and/or depression. Be curious, not judgmental.”

It is also important to ask about social and psychological factors that may be contributing to use and help the user think through how the use is affecting life in their home, school, and social settings, Dr. Appasani said.

He said he was not surprised by the findings as e-cigarettes allow easy access to smoking and it’s easier to hide the habit. The flavoring often get kids hooked originally.

The authors wrote: “These findings suggest that clinicians need to be ready to address youth addiction to these new highly addictive nicotine products during many clinical encounters, and stronger regulation is needed, including comprehensive bans on the sale of flavored tobacco products.”

Just more than half of the survey respondents (51.1%) were male and average age was 14. Researchers analyzed data from the National Youth Tobacco Survey, a nationally representative survey of middle and high school students.

They used the Youth Behavioral Risk Factor Surveillance System from 2015 to 2019 as a confirmatory analysis.

This study was supported in part by grants from the National Cancer Institute. Dr. Glantz received personal fees from the World Health Organization outside the submitted work. One coauthor reported serving as a paid expert witness against the tobacco industry outside the submitted work. No other disclosures were reported. Dr. Appasani declared no relevant financial relationships.

A machine-learning risk model that incorporates childhood characteristics can predict development of bipolar disorder up to a decade later, according to investigators.

This is the first quantitative approach to predict bipolar disorder, offering sensitivity and specificity of 75% and 76%, respectively, reported lead author Mai Uchida, MD, director of the pediatric depression program at Massachusetts General Hospital and assistant professor of psychiatry at Harvard Medical School, Boston, and colleagues. With further development, the model could be used to identify at-risk children via electronic medical records, enabling earlier monitoring and intervention.

“Although longitudinal studies have found the prognosis of early-onset mood disorders to be unfavorable, research has also shown there are effective treatments and therapies that could significantly alleviate the patients’ and their families’ struggles from the diagnoses,” the investigators wrote in the Journal of Psychiatric Research. “Thus, early identification of the risks and interventions for early symptoms of pediatric mood disorders is crucial.”

To this end, Dr. Uchida and colleagues teamed up with the Gabrieli Lab at MIT, who have published extensively in the realm of neurodevelopment. They sourced data from 492 children, 6-18 years at baseline, who were involved in two longitudinal case-control family studies focused on ADHD. Inputs included psychometric scales, structured diagnostic interviews, social and cognitive functioning assessments, and sociodemographic data.

At 10-year follow-up, 10% of these children had developed bipolar disorder, a notably higher rate than the 3%-4% prevalence in the general population.

“This is a population that’s overrepresented,” Dr. Uchida said in an interview.

She offered two primary reasons for this: First, the families involved in the study were probably willing to be followed for 10 years because they had ongoing concerns about their child’s mental health. Second, the studies enrolled children diagnosed with ADHD, a condition associated with increased risk of bipolar disorder.

Using machine learning algorithms that processed the baseline data while accounting for the skewed distribution, the investigators were able to predict which of the children in the population would go on to develop bipolar disorder. The final model offered a sensitivity of 75%, a specificity of 76%, and an area under the receiver operating characteristic curve of 75%.

“To the best of our knowledge, this represents the first study using machine-learning algorithms for this purpose in pediatric psychiatry,” the investigators wrote.
 

Integrating models into electronic medical records

In the future, this model, or one like it, could be incorporated into software that automatically analyzes electronic medical records and notifies physicians about high-risk patients, Dr. Uchida predicted.

“Not all patients would connect to intervention,” she said. “Maybe it just means that you invite them in for a visit, or you observe them a little bit more carefully. I think that’s where we are hoping that machine learning and medical practice will go.”

When asked about the potential bias posed by psychiatric evaluation, compared with something like blood work results, Dr. Uchida suggested that this subjectivity can be overcome.

“I’m not entirely bothered by that,” she said, offering a list of objective data points that could be harvested from records, such as number of referrals, medications, and hospitalizations. Narrative text in medical records could also be analyzed, she said, potentially detecting key words that are more often associated with high-risk patients.

“Risk prediction is never going to be 100% accurate,” Dr. Uchida said. “But I do think that there will be things [in electronic medical records] that could guide how worried we should be, or how quickly we should intervene.”
 

Opening doors to personalized care

Martin Gignac, MD, chief of psychiatry at Montreal Children’s Hospital and associate professor at McGill University, Montreal, said the present study offers further support for the existence of pediatric-onset bipolar disorder, which “remains controversial” despite “solid evidence.”

“I’m impressed that we have 10-year-long longitudinal follow-up studies that corroborate the importance of this disorder, and show strong predictors of who is at risk,” Dr. Gignac said in an interview. “Clinicians treating a pediatric population should be aware that some of those children with mental health problems might have severe mental health problems, and you have to have the appropriate tools to screen them.”

Advanced tools like the one developed by Dr. Uchida and colleagues should lead to more personalized care, he said.

“We’re going to be able to define what your individual risk is, and maybe most importantly, what you can do to prevent the development of certain disorders,” Dr. Gignac said. “Are there any risks that are dynamic in nature, and that we can act upon? Exposure to stress, for example.”

While more work is needed to bring machine learning into daily psychiatric practice, Dr. Gignac concluded on an optimistic note.

“These instruments should translate from research into clinical practice in order to make difference for the patients we care for,” he said. “This is the type of hope that I hold – that it’s going to be applicable in clinical practice, hopefully, in the near future.”

The investigators disclosed relationships with InCarda, Baylis Medical, Johnson & Johnson, and others. Dr. Gignac disclosed no relevant competing interests.

A machine-learning risk model that incorporates childhood characteristics can predict development of bipolar disorder up to a decade later, according to investigators.

This is the first quantitative approach to predict bipolar disorder, offering sensitivity and specificity of 75% and 76%, respectively, reported lead author Mai Uchida, MD, director of the pediatric depression program at Massachusetts General Hospital and assistant professor of psychiatry at Harvard Medical School, Boston, and colleagues. With further development, the model could be used to identify at-risk children via electronic medical records, enabling earlier monitoring and intervention.

“Although longitudinal studies have found the prognosis of early-onset mood disorders to be unfavorable, research has also shown there are effective treatments and therapies that could significantly alleviate the patients’ and their families’ struggles from the diagnoses,” the investigators wrote in the Journal of Psychiatric Research. “Thus, early identification of the risks and interventions for early symptoms of pediatric mood disorders is crucial.”

To this end, Dr. Uchida and colleagues teamed up with the Gabrieli Lab at MIT, who have published extensively in the realm of neurodevelopment. They sourced data from 492 children, 6-18 years at baseline, who were involved in two longitudinal case-control family studies focused on ADHD. Inputs included psychometric scales, structured diagnostic interviews, social and cognitive functioning assessments, and sociodemographic data.

At 10-year follow-up, 10% of these children had developed bipolar disorder, a notably higher rate than the 3%-4% prevalence in the general population.

“This is a population that’s overrepresented,” Dr. Uchida said in an interview.

She offered two primary reasons for this: First, the families involved in the study were probably willing to be followed for 10 years because they had ongoing concerns about their child’s mental health. Second, the studies enrolled children diagnosed with ADHD, a condition associated with increased risk of bipolar disorder.

Using machine learning algorithms that processed the baseline data while accounting for the skewed distribution, the investigators were able to predict which of the children in the population would go on to develop bipolar disorder. The final model offered a sensitivity of 75%, a specificity of 76%, and an area under the receiver operating characteristic curve of 75%.

“To the best of our knowledge, this represents the first study using machine-learning algorithms for this purpose in pediatric psychiatry,” the investigators wrote.
 

Integrating models into electronic medical records

In the future, this model, or one like it, could be incorporated into software that automatically analyzes electronic medical records and notifies physicians about high-risk patients, Dr. Uchida predicted.

“Not all patients would connect to intervention,” she said. “Maybe it just means that you invite them in for a visit, or you observe them a little bit more carefully. I think that’s where we are hoping that machine learning and medical practice will go.”

When asked about the potential bias posed by psychiatric evaluation, compared with something like blood work results, Dr. Uchida suggested that this subjectivity can be overcome.

“I’m not entirely bothered by that,” she said, offering a list of objective data points that could be harvested from records, such as number of referrals, medications, and hospitalizations. Narrative text in medical records could also be analyzed, she said, potentially detecting key words that are more often associated with high-risk patients.

“Risk prediction is never going to be 100% accurate,” Dr. Uchida said. “But I do think that there will be things [in electronic medical records] that could guide how worried we should be, or how quickly we should intervene.”
 

Opening doors to personalized care

Martin Gignac, MD, chief of psychiatry at Montreal Children’s Hospital and associate professor at McGill University, Montreal, said the present study offers further support for the existence of pediatric-onset bipolar disorder, which “remains controversial” despite “solid evidence.”

“I’m impressed that we have 10-year-long longitudinal follow-up studies that corroborate the importance of this disorder, and show strong predictors of who is at risk,” Dr. Gignac said in an interview. “Clinicians treating a pediatric population should be aware that some of those children with mental health problems might have severe mental health problems, and you have to have the appropriate tools to screen them.”

Advanced tools like the one developed by Dr. Uchida and colleagues should lead to more personalized care, he said.

“We’re going to be able to define what your individual risk is, and maybe most importantly, what you can do to prevent the development of certain disorders,” Dr. Gignac said. “Are there any risks that are dynamic in nature, and that we can act upon? Exposure to stress, for example.”

While more work is needed to bring machine learning into daily psychiatric practice, Dr. Gignac concluded on an optimistic note.

“These instruments should translate from research into clinical practice in order to make difference for the patients we care for,” he said. “This is the type of hope that I hold – that it’s going to be applicable in clinical practice, hopefully, in the near future.”

The investigators disclosed relationships with InCarda, Baylis Medical, Johnson & Johnson, and others. Dr. Gignac disclosed no relevant competing interests.

A machine-learning risk model that incorporates childhood characteristics can predict development of bipolar disorder up to a decade later, according to investigators.

This is the first quantitative approach to predict bipolar disorder, offering sensitivity and specificity of 75% and 76%, respectively, reported lead author Mai Uchida, MD, director of the pediatric depression program at Massachusetts General Hospital and assistant professor of psychiatry at Harvard Medical School, Boston, and colleagues. With further development, the model could be used to identify at-risk children via electronic medical records, enabling earlier monitoring and intervention.

“Although longitudinal studies have found the prognosis of early-onset mood disorders to be unfavorable, research has also shown there are effective treatments and therapies that could significantly alleviate the patients’ and their families’ struggles from the diagnoses,” the investigators wrote in the Journal of Psychiatric Research. “Thus, early identification of the risks and interventions for early symptoms of pediatric mood disorders is crucial.”

To this end, Dr. Uchida and colleagues teamed up with the Gabrieli Lab at MIT, who have published extensively in the realm of neurodevelopment. They sourced data from 492 children, 6-18 years at baseline, who were involved in two longitudinal case-control family studies focused on ADHD. Inputs included psychometric scales, structured diagnostic interviews, social and cognitive functioning assessments, and sociodemographic data.

At 10-year follow-up, 10% of these children had developed bipolar disorder, a notably higher rate than the 3%-4% prevalence in the general population.

“This is a population that’s overrepresented,” Dr. Uchida said in an interview.

She offered two primary reasons for this: First, the families involved in the study were probably willing to be followed for 10 years because they had ongoing concerns about their child’s mental health. Second, the studies enrolled children diagnosed with ADHD, a condition associated with increased risk of bipolar disorder.

Using machine learning algorithms that processed the baseline data while accounting for the skewed distribution, the investigators were able to predict which of the children in the population would go on to develop bipolar disorder. The final model offered a sensitivity of 75%, a specificity of 76%, and an area under the receiver operating characteristic curve of 75%.

“To the best of our knowledge, this represents the first study using machine-learning algorithms for this purpose in pediatric psychiatry,” the investigators wrote.
 

Integrating models into electronic medical records

In the future, this model, or one like it, could be incorporated into software that automatically analyzes electronic medical records and notifies physicians about high-risk patients, Dr. Uchida predicted.

“Not all patients would connect to intervention,” she said. “Maybe it just means that you invite them in for a visit, or you observe them a little bit more carefully. I think that’s where we are hoping that machine learning and medical practice will go.”

When asked about the potential bias posed by psychiatric evaluation, compared with something like blood work results, Dr. Uchida suggested that this subjectivity can be overcome.

“I’m not entirely bothered by that,” she said, offering a list of objective data points that could be harvested from records, such as number of referrals, medications, and hospitalizations. Narrative text in medical records could also be analyzed, she said, potentially detecting key words that are more often associated with high-risk patients.

“Risk prediction is never going to be 100% accurate,” Dr. Uchida said. “But I do think that there will be things [in electronic medical records] that could guide how worried we should be, or how quickly we should intervene.”
 

Opening doors to personalized care

Martin Gignac, MD, chief of psychiatry at Montreal Children’s Hospital and associate professor at McGill University, Montreal, said the present study offers further support for the existence of pediatric-onset bipolar disorder, which “remains controversial” despite “solid evidence.”

“I’m impressed that we have 10-year-long longitudinal follow-up studies that corroborate the importance of this disorder, and show strong predictors of who is at risk,” Dr. Gignac said in an interview. “Clinicians treating a pediatric population should be aware that some of those children with mental health problems might have severe mental health problems, and you have to have the appropriate tools to screen them.”

Advanced tools like the one developed by Dr. Uchida and colleagues should lead to more personalized care, he said.

“We’re going to be able to define what your individual risk is, and maybe most importantly, what you can do to prevent the development of certain disorders,” Dr. Gignac said. “Are there any risks that are dynamic in nature, and that we can act upon? Exposure to stress, for example.”

While more work is needed to bring machine learning into daily psychiatric practice, Dr. Gignac concluded on an optimistic note.

“These instruments should translate from research into clinical practice in order to make difference for the patients we care for,” he said. “This is the type of hope that I hold – that it’s going to be applicable in clinical practice, hopefully, in the near future.”

The investigators disclosed relationships with InCarda, Baylis Medical, Johnson & Johnson, and others. Dr. Gignac disclosed no relevant competing interests.

The Canadian Paediatric Society (CPS) has issued a position statement on the diagnosis of anxiety disorders in children and youth. The organization aims to “offer evidence-informed guidance to support pediatric health care providers making decisions around the care of children and adolescents with these conditions.”

“It’s been a long time coming,” lead author Benjamin Klein, MD, assistant clinical professor of pediatrics at McMaster University, Hamilton, Ont., told this news organization. The target audience for the documents includes community pediatricians, subspecialists, family doctors, and nurse practitioners. “There was a great demand from that audience for a position statement, for guidance, obviously in the backdrop of rising child and adolescent mental health incidence over the years and of course COVID,” said Dr. Klein.

The statement was published on the CPS website.
 

‘A comprehensive approach’

Although many other guidelines on this topic are available, it was important to have a Canadian document, said Dr. Klein. “Obviously, there’s going to be a great deal of overlap with European or American guidelines, but it’s just kind of assumed that people want specifically Canadian content. ... Physicians want to know that they’re practicing within a standard of care in Canada.” Dr. Klein is medical director of the Lansdowne Children’s Centre, Brantford, Ont., which provides help for children with communication, developmental, and physical special needs across Ontario.

Anxiety disorders are the most common mental disorders among children and adolescents in Canada, according to the position statement. The Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) groups these disorders into separation anxiety disorder, selective mutism, specific phobia, social anxiety disorder (social phobia), panic disorder, agoraphobia, and generalized anxiety disorder.

Distinguishing normal, age-appropriate anxiety from anxiety disorder, while also recognizing other comorbidities, is complicated, said Dr. Klein. “Anxiety is one possible diagnosis or feature, and children with mental health and developmental problems often present with a number of problems. Anxiety may be one of them, but if it’s one of them, it may not be the main driver. So, a comprehensive approach is needed ... combining the medical model with biopsychosocial thinking to give a better picture of anxiety in the context of anything else that may be contributing to a presentation.”

The statement outlines recommendations for anxiety assessment, starting with a screening questionnaire such as the Screen for Child Anxiety Related Disorders (SCARED), which is completed by parents and children, to assess symptom severity. Standardized measures for medical, mental health, and developmental histories are available on the CPS website.

The document next recommends an interview about presenting concerns (such as sleep problems or school difficulties), inciting events, and parent-child interactions. The process includes confidential, nonjudgmental interviews with adolescents using a history-taking tool such as HEEADSSS (Home, Education/Employment, Eating, Activities, Drugs, Sexuality, Suicide/Mental Health, and Safety).

“The diagnosis and treatment of anxiety disorders kind of sounds simple if you just read about it as an isolated thing, but the reality is ... there’s no MRI. It’s detective work,” said Dr. Klein. Clinicians must distinguish between normal anxiety, situational anxiety, and specific anxiety disorder, he added. He usually allows 90 minutes for an anxiety assessment, partly to gain the patient’s trust. “These are sensitive issues. It’s common that people don’t trust a diagnosis if you haven’t spent enough time with them. That relational care piece just needs to be there, or people aren’t going to buy in.”

The CPS position statement was reviewed and endorsed by the Canadian Academy of Child and Adolescent Psychiatry.
 

Methodology unclear

Joanna Henderson, MD, professor of psychiatry at the University of Toronto and director of the Margaret and Wallace McCain Centre for Child, Youth, and Family Mental Health at the Centre for Addiction and Mental Health, Toronto, said that the guidelines have been released at an important time. “Conversations about mental health have become more common, and many children, youth, and families are reaching out for support. It is essential that health care professionals be equipped with accessible information about practices to provide appropriate care. These guidelines support that vision.”

It would be helpful to know more about the methods used to arrive at the recommendations, however, said Dr. Henderson. “It is critical that health care providers be guided by evidence-based guidelines that adhere to criteria for establishing high-quality guidelines. Because the authors did not provide information about their methods, I am not able to provide a comment about the quality of their guidelines. There are established approaches for evaluating quality, and I would encourage the authors to publish as a supplement to this article their methods, including in reference to the Appraisal of Guidelines for Research and Evaluation (AGREE II) checklist.”

In the absence of readily available information about methods, she said, “clinicians are encouraged to use guidelines from sources that provide information about the guideline development process and include quality appraisal,” such as the UK National Institute for Health and Care Excellence, which is “generally recognized as a reputable source for high-quality practice guidelines.”

Responding to this concern, Dr. Klein said, “There is no specific evidence base for diagnosis. That robust science doesn’t exist. No one has done randomized controlled trials of different methods of diagnosing kids with anxiety. We looked at other position statements, we looked at textbooks, and obviously we drew from our own clinical experience, so it comes from clinical judgment and expert opinion.”

Dr. Henderson also noted that in the future “it will be important to contextualize the recommendations by highlighting the importance of cultural competence in conducting assessments and providing treatment.” Moreover, current evidence can be expanded through the incorporation of diverse cultural and racial perspectives, experiences, and data, she added.

Health service providers should reflect on their own potential biases, which can influence clinician-patient interactions, Dr. Henderson continued. It also is important to consider biases in the evidence, which influence practice. Clinicians should also consider how their recommendations fit with patients’ “cultural and race-based experiences, beliefs, and practices.”

No source of funding for the position statement was reported. Dr. Klein and Dr. Henderson had disclosed no relevant financial relationships.

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

The Canadian Paediatric Society (CPS) has issued a position statement on the diagnosis of anxiety disorders in children and youth. The organization aims to “offer evidence-informed guidance to support pediatric health care providers making decisions around the care of children and adolescents with these conditions.”

“It’s been a long time coming,” lead author Benjamin Klein, MD, assistant clinical professor of pediatrics at McMaster University, Hamilton, Ont., told this news organization. The target audience for the documents includes community pediatricians, subspecialists, family doctors, and nurse practitioners. “There was a great demand from that audience for a position statement, for guidance, obviously in the backdrop of rising child and adolescent mental health incidence over the years and of course COVID,” said Dr. Klein.

The statement was published on the CPS website.
 

‘A comprehensive approach’

Although many other guidelines on this topic are available, it was important to have a Canadian document, said Dr. Klein. “Obviously, there’s going to be a great deal of overlap with European or American guidelines, but it’s just kind of assumed that people want specifically Canadian content. ... Physicians want to know that they’re practicing within a standard of care in Canada.” Dr. Klein is medical director of the Lansdowne Children’s Centre, Brantford, Ont., which provides help for children with communication, developmental, and physical special needs across Ontario.

Anxiety disorders are the most common mental disorders among children and adolescents in Canada, according to the position statement. The Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) groups these disorders into separation anxiety disorder, selective mutism, specific phobia, social anxiety disorder (social phobia), panic disorder, agoraphobia, and generalized anxiety disorder.

Distinguishing normal, age-appropriate anxiety from anxiety disorder, while also recognizing other comorbidities, is complicated, said Dr. Klein. “Anxiety is one possible diagnosis or feature, and children with mental health and developmental problems often present with a number of problems. Anxiety may be one of them, but if it’s one of them, it may not be the main driver. So, a comprehensive approach is needed ... combining the medical model with biopsychosocial thinking to give a better picture of anxiety in the context of anything else that may be contributing to a presentation.”

The statement outlines recommendations for anxiety assessment, starting with a screening questionnaire such as the Screen for Child Anxiety Related Disorders (SCARED), which is completed by parents and children, to assess symptom severity. Standardized measures for medical, mental health, and developmental histories are available on the CPS website.

The document next recommends an interview about presenting concerns (such as sleep problems or school difficulties), inciting events, and parent-child interactions. The process includes confidential, nonjudgmental interviews with adolescents using a history-taking tool such as HEEADSSS (Home, Education/Employment, Eating, Activities, Drugs, Sexuality, Suicide/Mental Health, and Safety).

“The diagnosis and treatment of anxiety disorders kind of sounds simple if you just read about it as an isolated thing, but the reality is ... there’s no MRI. It’s detective work,” said Dr. Klein. Clinicians must distinguish between normal anxiety, situational anxiety, and specific anxiety disorder, he added. He usually allows 90 minutes for an anxiety assessment, partly to gain the patient’s trust. “These are sensitive issues. It’s common that people don’t trust a diagnosis if you haven’t spent enough time with them. That relational care piece just needs to be there, or people aren’t going to buy in.”

The CPS position statement was reviewed and endorsed by the Canadian Academy of Child and Adolescent Psychiatry.
 

Methodology unclear

Joanna Henderson, MD, professor of psychiatry at the University of Toronto and director of the Margaret and Wallace McCain Centre for Child, Youth, and Family Mental Health at the Centre for Addiction and Mental Health, Toronto, said that the guidelines have been released at an important time. “Conversations about mental health have become more common, and many children, youth, and families are reaching out for support. It is essential that health care professionals be equipped with accessible information about practices to provide appropriate care. These guidelines support that vision.”

It would be helpful to know more about the methods used to arrive at the recommendations, however, said Dr. Henderson. “It is critical that health care providers be guided by evidence-based guidelines that adhere to criteria for establishing high-quality guidelines. Because the authors did not provide information about their methods, I am not able to provide a comment about the quality of their guidelines. There are established approaches for evaluating quality, and I would encourage the authors to publish as a supplement to this article their methods, including in reference to the Appraisal of Guidelines for Research and Evaluation (AGREE II) checklist.”

In the absence of readily available information about methods, she said, “clinicians are encouraged to use guidelines from sources that provide information about the guideline development process and include quality appraisal,” such as the UK National Institute for Health and Care Excellence, which is “generally recognized as a reputable source for high-quality practice guidelines.”

Responding to this concern, Dr. Klein said, “There is no specific evidence base for diagnosis. That robust science doesn’t exist. No one has done randomized controlled trials of different methods of diagnosing kids with anxiety. We looked at other position statements, we looked at textbooks, and obviously we drew from our own clinical experience, so it comes from clinical judgment and expert opinion.”

Dr. Henderson also noted that in the future “it will be important to contextualize the recommendations by highlighting the importance of cultural competence in conducting assessments and providing treatment.” Moreover, current evidence can be expanded through the incorporation of diverse cultural and racial perspectives, experiences, and data, she added.

Health service providers should reflect on their own potential biases, which can influence clinician-patient interactions, Dr. Henderson continued. It also is important to consider biases in the evidence, which influence practice. Clinicians should also consider how their recommendations fit with patients’ “cultural and race-based experiences, beliefs, and practices.”

No source of funding for the position statement was reported. Dr. Klein and Dr. Henderson had disclosed no relevant financial relationships.

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

The Canadian Paediatric Society (CPS) has issued a position statement on the diagnosis of anxiety disorders in children and youth. The organization aims to “offer evidence-informed guidance to support pediatric health care providers making decisions around the care of children and adolescents with these conditions.”

“It’s been a long time coming,” lead author Benjamin Klein, MD, assistant clinical professor of pediatrics at McMaster University, Hamilton, Ont., told this news organization. The target audience for the documents includes community pediatricians, subspecialists, family doctors, and nurse practitioners. “There was a great demand from that audience for a position statement, for guidance, obviously in the backdrop of rising child and adolescent mental health incidence over the years and of course COVID,” said Dr. Klein.

The statement was published on the CPS website.
 

‘A comprehensive approach’

Although many other guidelines on this topic are available, it was important to have a Canadian document, said Dr. Klein. “Obviously, there’s going to be a great deal of overlap with European or American guidelines, but it’s just kind of assumed that people want specifically Canadian content. ... Physicians want to know that they’re practicing within a standard of care in Canada.” Dr. Klein is medical director of the Lansdowne Children’s Centre, Brantford, Ont., which provides help for children with communication, developmental, and physical special needs across Ontario.

Anxiety disorders are the most common mental disorders among children and adolescents in Canada, according to the position statement. The Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) groups these disorders into separation anxiety disorder, selective mutism, specific phobia, social anxiety disorder (social phobia), panic disorder, agoraphobia, and generalized anxiety disorder.

Distinguishing normal, age-appropriate anxiety from anxiety disorder, while also recognizing other comorbidities, is complicated, said Dr. Klein. “Anxiety is one possible diagnosis or feature, and children with mental health and developmental problems often present with a number of problems. Anxiety may be one of them, but if it’s one of them, it may not be the main driver. So, a comprehensive approach is needed ... combining the medical model with biopsychosocial thinking to give a better picture of anxiety in the context of anything else that may be contributing to a presentation.”

The statement outlines recommendations for anxiety assessment, starting with a screening questionnaire such as the Screen for Child Anxiety Related Disorders (SCARED), which is completed by parents and children, to assess symptom severity. Standardized measures for medical, mental health, and developmental histories are available on the CPS website.

The document next recommends an interview about presenting concerns (such as sleep problems or school difficulties), inciting events, and parent-child interactions. The process includes confidential, nonjudgmental interviews with adolescents using a history-taking tool such as HEEADSSS (Home, Education/Employment, Eating, Activities, Drugs, Sexuality, Suicide/Mental Health, and Safety).

“The diagnosis and treatment of anxiety disorders kind of sounds simple if you just read about it as an isolated thing, but the reality is ... there’s no MRI. It’s detective work,” said Dr. Klein. Clinicians must distinguish between normal anxiety, situational anxiety, and specific anxiety disorder, he added. He usually allows 90 minutes for an anxiety assessment, partly to gain the patient’s trust. “These are sensitive issues. It’s common that people don’t trust a diagnosis if you haven’t spent enough time with them. That relational care piece just needs to be there, or people aren’t going to buy in.”

The CPS position statement was reviewed and endorsed by the Canadian Academy of Child and Adolescent Psychiatry.
 

Methodology unclear

Joanna Henderson, MD, professor of psychiatry at the University of Toronto and director of the Margaret and Wallace McCain Centre for Child, Youth, and Family Mental Health at the Centre for Addiction and Mental Health, Toronto, said that the guidelines have been released at an important time. “Conversations about mental health have become more common, and many children, youth, and families are reaching out for support. It is essential that health care professionals be equipped with accessible information about practices to provide appropriate care. These guidelines support that vision.”

It would be helpful to know more about the methods used to arrive at the recommendations, however, said Dr. Henderson. “It is critical that health care providers be guided by evidence-based guidelines that adhere to criteria for establishing high-quality guidelines. Because the authors did not provide information about their methods, I am not able to provide a comment about the quality of their guidelines. There are established approaches for evaluating quality, and I would encourage the authors to publish as a supplement to this article their methods, including in reference to the Appraisal of Guidelines for Research and Evaluation (AGREE II) checklist.”

In the absence of readily available information about methods, she said, “clinicians are encouraged to use guidelines from sources that provide information about the guideline development process and include quality appraisal,” such as the UK National Institute for Health and Care Excellence, which is “generally recognized as a reputable source for high-quality practice guidelines.”

Responding to this concern, Dr. Klein said, “There is no specific evidence base for diagnosis. That robust science doesn’t exist. No one has done randomized controlled trials of different methods of diagnosing kids with anxiety. We looked at other position statements, we looked at textbooks, and obviously we drew from our own clinical experience, so it comes from clinical judgment and expert opinion.”

Dr. Henderson also noted that in the future “it will be important to contextualize the recommendations by highlighting the importance of cultural competence in conducting assessments and providing treatment.” Moreover, current evidence can be expanded through the incorporation of diverse cultural and racial perspectives, experiences, and data, she added.

Health service providers should reflect on their own potential biases, which can influence clinician-patient interactions, Dr. Henderson continued. It also is important to consider biases in the evidence, which influence practice. Clinicians should also consider how their recommendations fit with patients’ “cultural and race-based experiences, beliefs, and practices.”

No source of funding for the position statement was reported. Dr. Klein and Dr. Henderson had disclosed no relevant financial relationships.

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

The developmentally disabled girl was just 10 years old when Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin, Milwaukee, helped care for her. Providing that care was not emotionally easy. “Her brother’s friend sexually assaulted her and impregnated her,” Dr. Thew said.

The girl was able to obtain an abortion, a decision her parents supported. The alternative could have been deadly. “She was a tiny little person and would not have been able to carry a fetus,” Dr. Thew, a nurse practitioner, said.

Dr. Thew said she’s thankful that tragic case occurred before 2022. After the United States Supreme Court overturned Roe v. Wade in June, Wisconsin reverted to an 1849 law banning abortion. Although the law is currently being challenged, Dr. Thew wonders how the situation would have played out now. (Weeks after the Supreme Court’s decision, a similar case occurred in Ohio. In that case, a 10-year-old girl had to travel out of the state to obtain an abortion after having been raped.)

Talking to adolescents and young adults about reproductive health, whether regarding an unexpected pregnancy, the need for contraception, or to provide information about sexual activity, can be a challenge even for experienced health care providers.

The talks, decisions, and care are particularly complex when patients have developmental and intellectual disabilities. Among the many factors, Dr. Thew said, are dealing with menstruation, finding the right contraceptives, and counseling parents who might not want to acknowledge their children’s emerging sexuality.
 

Statistics: How many?

Because the definitions of disabilities vary and they represent a spectrum, estimates for how many youth have intellectual or developmental disabilities range widely.

In 2019, the National Survey of Children’s Health found that 1 in 4 children and adolescents aged 12-17 years have special health care needs because of disability. The American Community Survey estimates more than 1.3 million people aged 16-20 have a disability.

Intellectual disabilities can occur when a person’s IQ is below 70, significantly impeding the ability to perform activities of daily living, such as eating, dressing, and communicating. Developmental disabilities are impairments in physical, learning, language, and behavior, according to the United States Centers for Disease Control and Prevention. Among the conditions are attention-deficit/hyperactivity disorder, autism spectrum disorders, fragile X syndrome, learning and language problems, spina bifida, and other conditions.
 

Addressing common issues, concerns

April Kayser is a health educator for the Multnomah County Health Department, Portland, Ore. In 2016, Ms. Kayser and other experts conducted interviews with 11 youth with developmental and intellectual disabilities and 34 support people, either parents or professionals who provide services. The survey was part of the SHEIDD Project – short for Sexual Health Equity for Individuals with Intellectual/Developmental Disabilities – at Oregon Health and Science University (OHSU).

From their findings, the researchers compiled guidelines. They provided scenarios that health care providers need to be aware of and that they need to be ready to address:

• A boy, 14, who is unclear about what to do when he feels sexually excited and wants to masturbate but isn’t at home. He has been told that masturbation is appropriate in private.
• A 20-year-old woman who lives in a group home is pregnant. She confesses to her parents during a visit that another resident is her boyfriend and that he is the father of the child she is expecting.
• A 17-year-old boy wants to ask out another student, who is 15.

Some developmentally and intellectually disabled youth can’t turn to their parents for help. One person in the survey said his father told him, “You don’t need to worry about any of that stuff. You’re too young.” Another said the job of a health care provider was to offer reproductive and sex education “to make sure you don’t screw up in some bad way.”

One finding stood out: Health care providers were at the top of the list of those whom young people trusted for information about reproductive and sexual health, Ms. Kayser said. Yet in her experience, she said, health care professionals are hesitant to bring up the issues with all youth, “especially those with intellectual and developmental disabilities.”

Health care providers often talk both to the patient and to the parents. Those conversations can be critical when a child is developmentally or intellectually disabled.

Women with disabilities have been shown to have a higher risk for adverse outcomes of pregnancy, said Willi Horner-Johnson, PhD, associate professor at OHSU–Portland State University School of Public Health.

In a recent study, she and her colleagues analyzed data from the CDC’s National Survey of Family Growth that included self-reported disability status. They found that the number of women with disabilities who give birth is far higher than was previously thought.

The researchers found that 19.5% of respondents who gave birth reported at least one sensory, cognitive, or mobility-related disability, a rate that is much greater than the less than 1%-6.6% estimates that are based on hospital discharge data.

Her group reported other troubling findings: Women with disabilities are twice as likely to have smoked during their pregnancy (19% vs. 8.9%) and are more likely to have preterm and low-birthweight babies.
 

Clinicians play an important role

Dr. Horner-Johnson agreed with the finding from the Multnomah County survey that health care providers play an important role in providing those with intellectual and developmental disabilities reproductive health care that meets their needs. “Clinicians need to be asking people with disabilities about their reproductive plans,” she said.

In the Multnomah County report, the researchers advised health care providers to recognize that people with disabilities are social and sexual beings; to learn about their goals, including those regarding sex and reproductive health; and to help youth build skills for healthy relationships and sexual activity.

Dr. Horner-Johnson pointed out that the American College of Obstetricians and Gynecologists “recommends that clinicians discuss reproductive plans at every visit, for example, by asking one key question – ‘Would you like to become pregnant in the next year?’ – of every woman of reproductive age.”

Some women will not be able to answer that question, and health care providers at times must rely on a caregiver for input. But many women, even those with disabilities, could answer if given a chance. She estimated that only about 5% of disabled people are unable to communicate. “Clinicians defer to the caregiver more than they need to,” she said.

Clinicians are becoming better at providing care to those with disabilities, Dr. Horner-Johnson said, yet they have a way to go. Clinician biases may prevent some from asking all women, including those with disabilities, about their reproductive plans. “Women with disabilities have described clinicians treating them as nonsexual, assuming or implying that they would not or should not get pregnant,” she writes in her report.

Such biases, she said, could be reduced by increased education of providers. A 2018 study in Health Equity found that only 19.3% of ob.gyns. said they felt equipped to manage the pregnancy of a woman with disabilities.

Managing sexuality and sexual health for youth with disabilities can be highly complex, according to Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin, Milwaukee. Challenges include the following:

• Parents often can’t deal with the reality that their teen or young adult is sexually active or may become so. Parents she helps often prefer to use the term “hormones,” not contraceptives, when talking about pregnancy prevention.
• Menstruation is a frequent concern, especially for youth with severe disabilities. Some react strongly to seeing a sanitary pad with blood, for example, by throwing it. Parents worry that caregivers will balk at changing pads regularly. As a result, some parents want complete menstrual suppression, Dr. Thew said. The American Academy of Pediatrics outlines how to approach menstrual suppression through methods such as the use of estrogen-progestin, progesterone, a ring, or a patch. In late August, the American College of Obstetricians and Gynecologists released its clinical consensus on medical management of menstrual suppression.
• Some parents want to know how to obtain a complete hysterectomy for the patient – an option Dr. Thew and the AAP discourage. “We will tell them that’s not the best and safest approach, as you want to have the estrogen for bone health,” she said.
• After a discussion of all the options, an intrauterine device proves best for many. “That gives 7-8 years of protection,” she said, which is the approved effective duration for such devices. “They are less apt to have heavy monthly menstrual bleeding.”
• Parents of boys with disabilities, especially those with Down syndrome, often ask for sex education and guidance when sexual desires develop.
• Many parents want effective birth control for their children because of fear that their teen or young adult will be assaulted, a fear that isn’t groundless. Such cases are common, and caregivers frequently are the perpetrators.

Ms. Kayser, Dr. Horner-Johnson, and Dr. Thew have disclosed no relevant financial relationships.

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

The developmentally disabled girl was just 10 years old when Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin, Milwaukee, helped care for her. Providing that care was not emotionally easy. “Her brother’s friend sexually assaulted her and impregnated her,” Dr. Thew said.

The girl was able to obtain an abortion, a decision her parents supported. The alternative could have been deadly. “She was a tiny little person and would not have been able to carry a fetus,” Dr. Thew, a nurse practitioner, said.

Dr. Thew said she’s thankful that tragic case occurred before 2022. After the United States Supreme Court overturned Roe v. Wade in June, Wisconsin reverted to an 1849 law banning abortion. Although the law is currently being challenged, Dr. Thew wonders how the situation would have played out now. (Weeks after the Supreme Court’s decision, a similar case occurred in Ohio. In that case, a 10-year-old girl had to travel out of the state to obtain an abortion after having been raped.)

Talking to adolescents and young adults about reproductive health, whether regarding an unexpected pregnancy, the need for contraception, or to provide information about sexual activity, can be a challenge even for experienced health care providers.

The talks, decisions, and care are particularly complex when patients have developmental and intellectual disabilities. Among the many factors, Dr. Thew said, are dealing with menstruation, finding the right contraceptives, and counseling parents who might not want to acknowledge their children’s emerging sexuality.
 

Statistics: How many?

Because the definitions of disabilities vary and they represent a spectrum, estimates for how many youth have intellectual or developmental disabilities range widely.

In 2019, the National Survey of Children’s Health found that 1 in 4 children and adolescents aged 12-17 years have special health care needs because of disability. The American Community Survey estimates more than 1.3 million people aged 16-20 have a disability.

Intellectual disabilities can occur when a person’s IQ is below 70, significantly impeding the ability to perform activities of daily living, such as eating, dressing, and communicating. Developmental disabilities are impairments in physical, learning, language, and behavior, according to the United States Centers for Disease Control and Prevention. Among the conditions are attention-deficit/hyperactivity disorder, autism spectrum disorders, fragile X syndrome, learning and language problems, spina bifida, and other conditions.
 

Addressing common issues, concerns

April Kayser is a health educator for the Multnomah County Health Department, Portland, Ore. In 2016, Ms. Kayser and other experts conducted interviews with 11 youth with developmental and intellectual disabilities and 34 support people, either parents or professionals who provide services. The survey was part of the SHEIDD Project – short for Sexual Health Equity for Individuals with Intellectual/Developmental Disabilities – at Oregon Health and Science University (OHSU).

From their findings, the researchers compiled guidelines. They provided scenarios that health care providers need to be aware of and that they need to be ready to address:

• A boy, 14, who is unclear about what to do when he feels sexually excited and wants to masturbate but isn’t at home. He has been told that masturbation is appropriate in private.
• A 20-year-old woman who lives in a group home is pregnant. She confesses to her parents during a visit that another resident is her boyfriend and that he is the father of the child she is expecting.
• A 17-year-old boy wants to ask out another student, who is 15.

Some developmentally and intellectually disabled youth can’t turn to their parents for help. One person in the survey said his father told him, “You don’t need to worry about any of that stuff. You’re too young.” Another said the job of a health care provider was to offer reproductive and sex education “to make sure you don’t screw up in some bad way.”

One finding stood out: Health care providers were at the top of the list of those whom young people trusted for information about reproductive and sexual health, Ms. Kayser said. Yet in her experience, she said, health care professionals are hesitant to bring up the issues with all youth, “especially those with intellectual and developmental disabilities.”

Health care providers often talk both to the patient and to the parents. Those conversations can be critical when a child is developmentally or intellectually disabled.

Women with disabilities have been shown to have a higher risk for adverse outcomes of pregnancy, said Willi Horner-Johnson, PhD, associate professor at OHSU–Portland State University School of Public Health.

In a recent study, she and her colleagues analyzed data from the CDC’s National Survey of Family Growth that included self-reported disability status. They found that the number of women with disabilities who give birth is far higher than was previously thought.

The researchers found that 19.5% of respondents who gave birth reported at least one sensory, cognitive, or mobility-related disability, a rate that is much greater than the less than 1%-6.6% estimates that are based on hospital discharge data.

Her group reported other troubling findings: Women with disabilities are twice as likely to have smoked during their pregnancy (19% vs. 8.9%) and are more likely to have preterm and low-birthweight babies.
 

Clinicians play an important role

Dr. Horner-Johnson agreed with the finding from the Multnomah County survey that health care providers play an important role in providing those with intellectual and developmental disabilities reproductive health care that meets their needs. “Clinicians need to be asking people with disabilities about their reproductive plans,” she said.

In the Multnomah County report, the researchers advised health care providers to recognize that people with disabilities are social and sexual beings; to learn about their goals, including those regarding sex and reproductive health; and to help youth build skills for healthy relationships and sexual activity.

Dr. Horner-Johnson pointed out that the American College of Obstetricians and Gynecologists “recommends that clinicians discuss reproductive plans at every visit, for example, by asking one key question – ‘Would you like to become pregnant in the next year?’ – of every woman of reproductive age.”

Some women will not be able to answer that question, and health care providers at times must rely on a caregiver for input. But many women, even those with disabilities, could answer if given a chance. She estimated that only about 5% of disabled people are unable to communicate. “Clinicians defer to the caregiver more than they need to,” she said.

Clinicians are becoming better at providing care to those with disabilities, Dr. Horner-Johnson said, yet they have a way to go. Clinician biases may prevent some from asking all women, including those with disabilities, about their reproductive plans. “Women with disabilities have described clinicians treating them as nonsexual, assuming or implying that they would not or should not get pregnant,” she writes in her report.

Such biases, she said, could be reduced by increased education of providers. A 2018 study in Health Equity found that only 19.3% of ob.gyns. said they felt equipped to manage the pregnancy of a woman with disabilities.

Managing sexuality and sexual health for youth with disabilities can be highly complex, according to Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin, Milwaukee. Challenges include the following:

• Parents often can’t deal with the reality that their teen or young adult is sexually active or may become so. Parents she helps often prefer to use the term “hormones,” not contraceptives, when talking about pregnancy prevention.
• Menstruation is a frequent concern, especially for youth with severe disabilities. Some react strongly to seeing a sanitary pad with blood, for example, by throwing it. Parents worry that caregivers will balk at changing pads regularly. As a result, some parents want complete menstrual suppression, Dr. Thew said. The American Academy of Pediatrics outlines how to approach menstrual suppression through methods such as the use of estrogen-progestin, progesterone, a ring, or a patch. In late August, the American College of Obstetricians and Gynecologists released its clinical consensus on medical management of menstrual suppression.
• Some parents want to know how to obtain a complete hysterectomy for the patient – an option Dr. Thew and the AAP discourage. “We will tell them that’s not the best and safest approach, as you want to have the estrogen for bone health,” she said.
• After a discussion of all the options, an intrauterine device proves best for many. “That gives 7-8 years of protection,” she said, which is the approved effective duration for such devices. “They are less apt to have heavy monthly menstrual bleeding.”
• Parents of boys with disabilities, especially those with Down syndrome, often ask for sex education and guidance when sexual desires develop.
• Many parents want effective birth control for their children because of fear that their teen or young adult will be assaulted, a fear that isn’t groundless. Such cases are common, and caregivers frequently are the perpetrators.

Ms. Kayser, Dr. Horner-Johnson, and Dr. Thew have disclosed no relevant financial relationships.

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

The developmentally disabled girl was just 10 years old when Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin, Milwaukee, helped care for her. Providing that care was not emotionally easy. “Her brother’s friend sexually assaulted her and impregnated her,” Dr. Thew said.

The girl was able to obtain an abortion, a decision her parents supported. The alternative could have been deadly. “She was a tiny little person and would not have been able to carry a fetus,” Dr. Thew, a nurse practitioner, said.

Dr. Thew said she’s thankful that tragic case occurred before 2022. After the United States Supreme Court overturned Roe v. Wade in June, Wisconsin reverted to an 1849 law banning abortion. Although the law is currently being challenged, Dr. Thew wonders how the situation would have played out now. (Weeks after the Supreme Court’s decision, a similar case occurred in Ohio. In that case, a 10-year-old girl had to travel out of the state to obtain an abortion after having been raped.)

Talking to adolescents and young adults about reproductive health, whether regarding an unexpected pregnancy, the need for contraception, or to provide information about sexual activity, can be a challenge even for experienced health care providers.

The talks, decisions, and care are particularly complex when patients have developmental and intellectual disabilities. Among the many factors, Dr. Thew said, are dealing with menstruation, finding the right contraceptives, and counseling parents who might not want to acknowledge their children’s emerging sexuality.
 

Statistics: How many?

Because the definitions of disabilities vary and they represent a spectrum, estimates for how many youth have intellectual or developmental disabilities range widely.

In 2019, the National Survey of Children’s Health found that 1 in 4 children and adolescents aged 12-17 years have special health care needs because of disability. The American Community Survey estimates more than 1.3 million people aged 16-20 have a disability.

Intellectual disabilities can occur when a person’s IQ is below 70, significantly impeding the ability to perform activities of daily living, such as eating, dressing, and communicating. Developmental disabilities are impairments in physical, learning, language, and behavior, according to the United States Centers for Disease Control and Prevention. Among the conditions are attention-deficit/hyperactivity disorder, autism spectrum disorders, fragile X syndrome, learning and language problems, spina bifida, and other conditions.
 

Addressing common issues, concerns

April Kayser is a health educator for the Multnomah County Health Department, Portland, Ore. In 2016, Ms. Kayser and other experts conducted interviews with 11 youth with developmental and intellectual disabilities and 34 support people, either parents or professionals who provide services. The survey was part of the SHEIDD Project – short for Sexual Health Equity for Individuals with Intellectual/Developmental Disabilities – at Oregon Health and Science University (OHSU).

From their findings, the researchers compiled guidelines. They provided scenarios that health care providers need to be aware of and that they need to be ready to address:

• A boy, 14, who is unclear about what to do when he feels sexually excited and wants to masturbate but isn’t at home. He has been told that masturbation is appropriate in private.
• A 20-year-old woman who lives in a group home is pregnant. She confesses to her parents during a visit that another resident is her boyfriend and that he is the father of the child she is expecting.
• A 17-year-old boy wants to ask out another student, who is 15.

Some developmentally and intellectually disabled youth can’t turn to their parents for help. One person in the survey said his father told him, “You don’t need to worry about any of that stuff. You’re too young.” Another said the job of a health care provider was to offer reproductive and sex education “to make sure you don’t screw up in some bad way.”

One finding stood out: Health care providers were at the top of the list of those whom young people trusted for information about reproductive and sexual health, Ms. Kayser said. Yet in her experience, she said, health care professionals are hesitant to bring up the issues with all youth, “especially those with intellectual and developmental disabilities.”

Health care providers often talk both to the patient and to the parents. Those conversations can be critical when a child is developmentally or intellectually disabled.

Women with disabilities have been shown to have a higher risk for adverse outcomes of pregnancy, said Willi Horner-Johnson, PhD, associate professor at OHSU–Portland State University School of Public Health.

In a recent study, she and her colleagues analyzed data from the CDC’s National Survey of Family Growth that included self-reported disability status. They found that the number of women with disabilities who give birth is far higher than was previously thought.

The researchers found that 19.5% of respondents who gave birth reported at least one sensory, cognitive, or mobility-related disability, a rate that is much greater than the less than 1%-6.6% estimates that are based on hospital discharge data.

Her group reported other troubling findings: Women with disabilities are twice as likely to have smoked during their pregnancy (19% vs. 8.9%) and are more likely to have preterm and low-birthweight babies.
 

Clinicians play an important role

Dr. Horner-Johnson agreed with the finding from the Multnomah County survey that health care providers play an important role in providing those with intellectual and developmental disabilities reproductive health care that meets their needs. “Clinicians need to be asking people with disabilities about their reproductive plans,” she said.

In the Multnomah County report, the researchers advised health care providers to recognize that people with disabilities are social and sexual beings; to learn about their goals, including those regarding sex and reproductive health; and to help youth build skills for healthy relationships and sexual activity.

Dr. Horner-Johnson pointed out that the American College of Obstetricians and Gynecologists “recommends that clinicians discuss reproductive plans at every visit, for example, by asking one key question – ‘Would you like to become pregnant in the next year?’ – of every woman of reproductive age.”

Some women will not be able to answer that question, and health care providers at times must rely on a caregiver for input. But many women, even those with disabilities, could answer if given a chance. She estimated that only about 5% of disabled people are unable to communicate. “Clinicians defer to the caregiver more than they need to,” she said.

Clinicians are becoming better at providing care to those with disabilities, Dr. Horner-Johnson said, yet they have a way to go. Clinician biases may prevent some from asking all women, including those with disabilities, about their reproductive plans. “Women with disabilities have described clinicians treating them as nonsexual, assuming or implying that they would not or should not get pregnant,” she writes in her report.

Such biases, she said, could be reduced by increased education of providers. A 2018 study in Health Equity found that only 19.3% of ob.gyns. said they felt equipped to manage the pregnancy of a woman with disabilities.

Managing sexuality and sexual health for youth with disabilities can be highly complex, according to Margaret Thew, DNP, medical director of adolescent medicine at Children’s Wisconsin, Milwaukee. Challenges include the following:

• Parents often can’t deal with the reality that their teen or young adult is sexually active or may become so. Parents she helps often prefer to use the term “hormones,” not contraceptives, when talking about pregnancy prevention.
• Menstruation is a frequent concern, especially for youth with severe disabilities. Some react strongly to seeing a sanitary pad with blood, for example, by throwing it. Parents worry that caregivers will balk at changing pads regularly. As a result, some parents want complete menstrual suppression, Dr. Thew said. The American Academy of Pediatrics outlines how to approach menstrual suppression through methods such as the use of estrogen-progestin, progesterone, a ring, or a patch. In late August, the American College of Obstetricians and Gynecologists released its clinical consensus on medical management of menstrual suppression.
• Some parents want to know how to obtain a complete hysterectomy for the patient – an option Dr. Thew and the AAP discourage. “We will tell them that’s not the best and safest approach, as you want to have the estrogen for bone health,” she said.
• After a discussion of all the options, an intrauterine device proves best for many. “That gives 7-8 years of protection,” she said, which is the approved effective duration for such devices. “They are less apt to have heavy monthly menstrual bleeding.”
• Parents of boys with disabilities, especially those with Down syndrome, often ask for sex education and guidance when sexual desires develop.
• Many parents want effective birth control for their children because of fear that their teen or young adult will be assaulted, a fear that isn’t groundless. Such cases are common, and caregivers frequently are the perpetrators.

Ms. Kayser, Dr. Horner-Johnson, and Dr. Thew have disclosed no relevant financial relationships.

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