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‘Shocking’ early complications from teen-onset type 2 diabetes

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Changed
Tue, 05/03/2022 - 15:05

Newly published data show alarmingly high rates and severity of early diabetes-specific complications in individuals who develop type 2 diabetes at a young age. This suggests intervention should be early and aggressive among these youngsters, said the researchers.

AzmanJaka/E+/Getty Images

The results for the 500 young adult participants in the Treatment Options for Type 2 Diabetes in Adolescents and Youth 2 (TODAY 2) study were published online July 29 in the New England Journal of Medicine by the TODAY study group.

At follow-up – after originally participating in the TODAY trial when they were young teenagers – they had a mean age of 26.4 years.

At this time, more than two thirds had hypertension and half had dyslipidemia.

Overall, 60% had at least one diabetic microvascular complication (retinal disease, neuropathy, or diabetic kidney disease), and more than a quarter had two or more such complications.

“These data illustrate the serious personal and public health consequences of youth-onset type 2 diabetes in the transition to adulthood,” the researchers noted.
 

Don’t tread lightly just because they are young

“The fact that these youth are accumulating complications at a rapid rate and are broadly affected early in adulthood certainly suggests that aggressive therapy is needed, both for glycemic control and treatment of risk factors like hypertension and dyslipidemia,” study coauthor Philip S. Zeitler, MD, PhD, said in an interview.

“In the absence of studies specifically addressing this, we need to take a more aggressive approach than people might be inclined to, given that the age at diagnosis is young, around 14 years,” he added.

“Contrary to the inclination to be ‘gentle’ in treating them because they are kids, these data suggest that we can’t let these initial years go by without strong intervention, and we need to be prepared for polypharmacy.”

Unfortunately, as Dr. Zeitler and coauthors explained, youth-onset type 2 diabetes is characterized by a suboptimal response to currently approved diabetes medications.

New pediatric indications in the United States for drugs used to treat type 2 diabetes in adults, including the recent Food and Drug Administration approval of extended-release exenatide for children as young as 10 years of age, “helps, but only marginally,” said Dr. Zeitler, of the Clinical & Translational Research Center, Children’s Hospital Colorado, Aurora.

“In some cases, it will help get them covered by carriers, which is always good. But this is still a very limited set of medications. It doesn’t include more recently approved more potent glucagon-like peptide-1 (GLP-1) agonists, like semaglutide, and doesn’t include the sodium-glucose cotransporter 2 (SGLT2) inhibitors. Pediatricians are used to using medications off label and that is necessary here while we await further approvals,” he said.  

And he noted that most individuals with youth-onset type 2 diabetes in the United States are covered by public insurance or are uninsured, depending on which state they live in. While the two major Medicaid programs in Colorado allow full access to adult formularies, that’s not the case everywhere. Moreover, patients often face further access barriers in states without expanded Medicaid.
 

Follow-up shows all metrics worsening over time

In TODAY 2, patients participated in an observational follow-up in their usual care settings in 2011-2020. At the start, they were receiving metformin with or without insulin for diabetes, but whether this continued and whether they were treated for other risk factors was down to individual circumstances.

Participants’ median A1c increased over time, and the percentage with A1c < 6% (< 48 mmol/mol) declined from 75% at the time of TODAY entry to just 19% at the 15-year end of follow-up.

The proportion with an A1c ≤ 10% (≤ 86 mmol/mol) rose from 0% at baseline to 34% at 15 years.

At that time, nearly 50% were taking both metformin and insulin, while more than a quarter were taking no medications.

The prevalence of hypertension increased from 19.2% at baseline to 67.5% at 15 years, while dyslipidemia rose from 20.8% to 51.6%.

Kidney disease prevalence increased from 8.0% at baseline to 54.8% at 15 years. Nerve disease rose from 1.0% to 32.4%. Retinal disease jumped from 13.7% with milder nonproliferative retinopathy in 2010-2011 to 51.0% with any eye disease in 2017-2018, including 8.8% with moderate to severe retinal changes and 3.5% with macular edema.  

Overall, at the time of the last visit, 39.9% had no diabetes complications, 31.8% had one, 21.3% had two, and 7.1% had three complications.
 

Serious cardiovascular events in mid-20s

There were 17 adjudicated serious cardiovascular events, including four myocardial infarctions, six heart failure events, three diagnoses of coronary artery disease, and four strokes.

Six participants died, one each from myocardial infarction, kidney failure, and drug overdose, and three from sepsis.

Dr. Zeitler called the macrovascular events “shocking,” noting that although the numbers are small, for people in their mid-20s “they should be zero ... While we don’t yet know if the rates are the same or faster than in adults, even if they are the same, these kids are only in their late 20s, as opposed to adults experiencing these problems in their 50s, 60s, and 70s.  

“The fact that these complications are occurring when these individuals should be in the prime of their life for both family and work has huge implications,” he stressed.
 

Findings have multiple causes

The reasons for the findings are both biologic and socioeconomic, Dr. Zeitler said.

“We know already that many kids with type 2 have rapid [deterioration of] beta-cell [function], which is probably very biologic. It stands to reason that an individual who can get diabetes as an adolescent probably has more fragile beta cells in some way,” he noted.

“But we also know that many other things contribute: stress, social determinants, access to quality care and medications, access to healthy foods and physical activity, availability of family supervision given the realities of families’ economic status and jobs, etc.”

It’s also known that youth with type 2 diabetes have much more severe insulin resistance than that of adults with the condition, and that “once the kids left ... the [TODAY] study, risk factor treatment in the community was less than ideal, and a lot of kids who met criteria for treatment of their blood pressure or lipids were not being treated. This is likely at least partly sociologic and partly the general pediatric hesitancy to use medications.”

He said the TODAY team will soon have some new data to show that “glycemia during the early years makes a difference, again supporting intensive intervention early on.”

The TODAY study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Zeitler had no further disclosures.

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

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Newly published data show alarmingly high rates and severity of early diabetes-specific complications in individuals who develop type 2 diabetes at a young age. This suggests intervention should be early and aggressive among these youngsters, said the researchers.

AzmanJaka/E+/Getty Images

The results for the 500 young adult participants in the Treatment Options for Type 2 Diabetes in Adolescents and Youth 2 (TODAY 2) study were published online July 29 in the New England Journal of Medicine by the TODAY study group.

At follow-up – after originally participating in the TODAY trial when they were young teenagers – they had a mean age of 26.4 years.

At this time, more than two thirds had hypertension and half had dyslipidemia.

Overall, 60% had at least one diabetic microvascular complication (retinal disease, neuropathy, or diabetic kidney disease), and more than a quarter had two or more such complications.

“These data illustrate the serious personal and public health consequences of youth-onset type 2 diabetes in the transition to adulthood,” the researchers noted.
 

Don’t tread lightly just because they are young

“The fact that these youth are accumulating complications at a rapid rate and are broadly affected early in adulthood certainly suggests that aggressive therapy is needed, both for glycemic control and treatment of risk factors like hypertension and dyslipidemia,” study coauthor Philip S. Zeitler, MD, PhD, said in an interview.

“In the absence of studies specifically addressing this, we need to take a more aggressive approach than people might be inclined to, given that the age at diagnosis is young, around 14 years,” he added.

“Contrary to the inclination to be ‘gentle’ in treating them because they are kids, these data suggest that we can’t let these initial years go by without strong intervention, and we need to be prepared for polypharmacy.”

Unfortunately, as Dr. Zeitler and coauthors explained, youth-onset type 2 diabetes is characterized by a suboptimal response to currently approved diabetes medications.

New pediatric indications in the United States for drugs used to treat type 2 diabetes in adults, including the recent Food and Drug Administration approval of extended-release exenatide for children as young as 10 years of age, “helps, but only marginally,” said Dr. Zeitler, of the Clinical & Translational Research Center, Children’s Hospital Colorado, Aurora.

“In some cases, it will help get them covered by carriers, which is always good. But this is still a very limited set of medications. It doesn’t include more recently approved more potent glucagon-like peptide-1 (GLP-1) agonists, like semaglutide, and doesn’t include the sodium-glucose cotransporter 2 (SGLT2) inhibitors. Pediatricians are used to using medications off label and that is necessary here while we await further approvals,” he said.  

And he noted that most individuals with youth-onset type 2 diabetes in the United States are covered by public insurance or are uninsured, depending on which state they live in. While the two major Medicaid programs in Colorado allow full access to adult formularies, that’s not the case everywhere. Moreover, patients often face further access barriers in states without expanded Medicaid.
 

Follow-up shows all metrics worsening over time

In TODAY 2, patients participated in an observational follow-up in their usual care settings in 2011-2020. At the start, they were receiving metformin with or without insulin for diabetes, but whether this continued and whether they were treated for other risk factors was down to individual circumstances.

Participants’ median A1c increased over time, and the percentage with A1c < 6% (< 48 mmol/mol) declined from 75% at the time of TODAY entry to just 19% at the 15-year end of follow-up.

The proportion with an A1c ≤ 10% (≤ 86 mmol/mol) rose from 0% at baseline to 34% at 15 years.

At that time, nearly 50% were taking both metformin and insulin, while more than a quarter were taking no medications.

The prevalence of hypertension increased from 19.2% at baseline to 67.5% at 15 years, while dyslipidemia rose from 20.8% to 51.6%.

Kidney disease prevalence increased from 8.0% at baseline to 54.8% at 15 years. Nerve disease rose from 1.0% to 32.4%. Retinal disease jumped from 13.7% with milder nonproliferative retinopathy in 2010-2011 to 51.0% with any eye disease in 2017-2018, including 8.8% with moderate to severe retinal changes and 3.5% with macular edema.  

Overall, at the time of the last visit, 39.9% had no diabetes complications, 31.8% had one, 21.3% had two, and 7.1% had three complications.
 

Serious cardiovascular events in mid-20s

There were 17 adjudicated serious cardiovascular events, including four myocardial infarctions, six heart failure events, three diagnoses of coronary artery disease, and four strokes.

Six participants died, one each from myocardial infarction, kidney failure, and drug overdose, and three from sepsis.

Dr. Zeitler called the macrovascular events “shocking,” noting that although the numbers are small, for people in their mid-20s “they should be zero ... While we don’t yet know if the rates are the same or faster than in adults, even if they are the same, these kids are only in their late 20s, as opposed to adults experiencing these problems in their 50s, 60s, and 70s.  

“The fact that these complications are occurring when these individuals should be in the prime of their life for both family and work has huge implications,” he stressed.
 

Findings have multiple causes

The reasons for the findings are both biologic and socioeconomic, Dr. Zeitler said.

“We know already that many kids with type 2 have rapid [deterioration of] beta-cell [function], which is probably very biologic. It stands to reason that an individual who can get diabetes as an adolescent probably has more fragile beta cells in some way,” he noted.

“But we also know that many other things contribute: stress, social determinants, access to quality care and medications, access to healthy foods and physical activity, availability of family supervision given the realities of families’ economic status and jobs, etc.”

It’s also known that youth with type 2 diabetes have much more severe insulin resistance than that of adults with the condition, and that “once the kids left ... the [TODAY] study, risk factor treatment in the community was less than ideal, and a lot of kids who met criteria for treatment of their blood pressure or lipids were not being treated. This is likely at least partly sociologic and partly the general pediatric hesitancy to use medications.”

He said the TODAY team will soon have some new data to show that “glycemia during the early years makes a difference, again supporting intensive intervention early on.”

The TODAY study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Zeitler had no further disclosures.

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

Newly published data show alarmingly high rates and severity of early diabetes-specific complications in individuals who develop type 2 diabetes at a young age. This suggests intervention should be early and aggressive among these youngsters, said the researchers.

AzmanJaka/E+/Getty Images

The results for the 500 young adult participants in the Treatment Options for Type 2 Diabetes in Adolescents and Youth 2 (TODAY 2) study were published online July 29 in the New England Journal of Medicine by the TODAY study group.

At follow-up – after originally participating in the TODAY trial when they were young teenagers – they had a mean age of 26.4 years.

At this time, more than two thirds had hypertension and half had dyslipidemia.

Overall, 60% had at least one diabetic microvascular complication (retinal disease, neuropathy, or diabetic kidney disease), and more than a quarter had two or more such complications.

“These data illustrate the serious personal and public health consequences of youth-onset type 2 diabetes in the transition to adulthood,” the researchers noted.
 

Don’t tread lightly just because they are young

“The fact that these youth are accumulating complications at a rapid rate and are broadly affected early in adulthood certainly suggests that aggressive therapy is needed, both for glycemic control and treatment of risk factors like hypertension and dyslipidemia,” study coauthor Philip S. Zeitler, MD, PhD, said in an interview.

“In the absence of studies specifically addressing this, we need to take a more aggressive approach than people might be inclined to, given that the age at diagnosis is young, around 14 years,” he added.

“Contrary to the inclination to be ‘gentle’ in treating them because they are kids, these data suggest that we can’t let these initial years go by without strong intervention, and we need to be prepared for polypharmacy.”

Unfortunately, as Dr. Zeitler and coauthors explained, youth-onset type 2 diabetes is characterized by a suboptimal response to currently approved diabetes medications.

New pediatric indications in the United States for drugs used to treat type 2 diabetes in adults, including the recent Food and Drug Administration approval of extended-release exenatide for children as young as 10 years of age, “helps, but only marginally,” said Dr. Zeitler, of the Clinical & Translational Research Center, Children’s Hospital Colorado, Aurora.

“In some cases, it will help get them covered by carriers, which is always good. But this is still a very limited set of medications. It doesn’t include more recently approved more potent glucagon-like peptide-1 (GLP-1) agonists, like semaglutide, and doesn’t include the sodium-glucose cotransporter 2 (SGLT2) inhibitors. Pediatricians are used to using medications off label and that is necessary here while we await further approvals,” he said.  

And he noted that most individuals with youth-onset type 2 diabetes in the United States are covered by public insurance or are uninsured, depending on which state they live in. While the two major Medicaid programs in Colorado allow full access to adult formularies, that’s not the case everywhere. Moreover, patients often face further access barriers in states without expanded Medicaid.
 

Follow-up shows all metrics worsening over time

In TODAY 2, patients participated in an observational follow-up in their usual care settings in 2011-2020. At the start, they were receiving metformin with or without insulin for diabetes, but whether this continued and whether they were treated for other risk factors was down to individual circumstances.

Participants’ median A1c increased over time, and the percentage with A1c < 6% (< 48 mmol/mol) declined from 75% at the time of TODAY entry to just 19% at the 15-year end of follow-up.

The proportion with an A1c ≤ 10% (≤ 86 mmol/mol) rose from 0% at baseline to 34% at 15 years.

At that time, nearly 50% were taking both metformin and insulin, while more than a quarter were taking no medications.

The prevalence of hypertension increased from 19.2% at baseline to 67.5% at 15 years, while dyslipidemia rose from 20.8% to 51.6%.

Kidney disease prevalence increased from 8.0% at baseline to 54.8% at 15 years. Nerve disease rose from 1.0% to 32.4%. Retinal disease jumped from 13.7% with milder nonproliferative retinopathy in 2010-2011 to 51.0% with any eye disease in 2017-2018, including 8.8% with moderate to severe retinal changes and 3.5% with macular edema.  

Overall, at the time of the last visit, 39.9% had no diabetes complications, 31.8% had one, 21.3% had two, and 7.1% had three complications.
 

Serious cardiovascular events in mid-20s

There were 17 adjudicated serious cardiovascular events, including four myocardial infarctions, six heart failure events, three diagnoses of coronary artery disease, and four strokes.

Six participants died, one each from myocardial infarction, kidney failure, and drug overdose, and three from sepsis.

Dr. Zeitler called the macrovascular events “shocking,” noting that although the numbers are small, for people in their mid-20s “they should be zero ... While we don’t yet know if the rates are the same or faster than in adults, even if they are the same, these kids are only in their late 20s, as opposed to adults experiencing these problems in their 50s, 60s, and 70s.  

“The fact that these complications are occurring when these individuals should be in the prime of their life for both family and work has huge implications,” he stressed.
 

Findings have multiple causes

The reasons for the findings are both biologic and socioeconomic, Dr. Zeitler said.

“We know already that many kids with type 2 have rapid [deterioration of] beta-cell [function], which is probably very biologic. It stands to reason that an individual who can get diabetes as an adolescent probably has more fragile beta cells in some way,” he noted.

“But we also know that many other things contribute: stress, social determinants, access to quality care and medications, access to healthy foods and physical activity, availability of family supervision given the realities of families’ economic status and jobs, etc.”

It’s also known that youth with type 2 diabetes have much more severe insulin resistance than that of adults with the condition, and that “once the kids left ... the [TODAY] study, risk factor treatment in the community was less than ideal, and a lot of kids who met criteria for treatment of their blood pressure or lipids were not being treated. This is likely at least partly sociologic and partly the general pediatric hesitancy to use medications.”

He said the TODAY team will soon have some new data to show that “glycemia during the early years makes a difference, again supporting intensive intervention early on.”

The TODAY study was supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Zeitler had no further disclosures.

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

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Study estimates carbon footprint reduction of virtual isotretinoin visits

Article Type
Changed
Fri, 07/30/2021 - 17:56

The environmental impact of virtual isotretinoin management at West Virginia University Hospital (WVUH) in 2020 has been estimated in a new study: A reduction of 5,137 kg of greenhouse gas emissions in carbon dioxide equivalents.

In what they say is “one of the first studies to evaluate the environmental impact of any aspect of dermatology,” the authors of the retrospective cross-sectional study identified patients who had virtual visits for isotretinoin management between March 25 and May 29, 2020, – the period during which all such visits were conducted virtually in keeping with hospital recommendations to minimize the spread of COVID-19.

The investigators, from the department of dermatology and the department of civil and environmental engineering at West Virginia University, Morgantown, then counted the number of virtual visits that occurred during this period and through Dec. 1, 2020, (175 virtual visits), calculated the distance patients would have traveled round-trip had these visits been in-person, and converted miles saved into the environmental impact using U.S. Environmental Protection Agency and Federal Highway Administration data and relevant EPA standards.

Most patients had elected to continue virtual visits after May 29, the point at which patients were given the option to return to the WVUH clinic. (Patients who initiated treatment during the 2-month identification period were not included.)

The investigators determined that virtual management of isotretinoin saved a median of 37.8 miles per visit during the study period of March 25 to Dec. 1, and estimated that the virtual visits reduced total travel by 14,450 miles. For the analysis, patients were assumed to use light-duty vehicles.

In addition to calculating the reduction in emissions during the study period (5,137 kg of CO2equivalents) they used patient census data from 2019 to 2020 and data from the study period to project the mileage – and the associated emissions – that would be saved annually if all in-person visits for isotretinoin management occurred virtually.

Their calculation for a projected emissions reduction with 1 year of all-virtual isotretinoin management was 49,400 kg of greenhouse gas emissions in CO2equivalents. This is the emission load released when 24,690 kg of coal are burned or 6.3 million smartphones are charged, the researchers wrote.

“Considering that more than 1,000,000 prescriptions of isotretinoin are authorized annually in the United States, the environmental impact could be magnified if virtual delivery of isotretinoin care is adopted on a national scale,” they commented.“Given the serious consequences of global climate change, analysis of the environmental impact of all fields of medicine, including dermatology, is warranted,” they added.

The reduced greenhouse gas emissions are “definitely [being taken] into consideration for future decisions about virtual visits” in the department of dermatology, said Zachary Zinn, MD, residency director and associate professor in the department of dermatology at West Virginia University, Morgantown, who is the senior author of the study. “The main benefit of virtual care in my opinion,” he said in an interview, “is the potential to reduce our carbon footprint.”



Justin Lee, MD, an intern at WVU and the study’s first author, said that the research team was motivated to think about how they “could reduce the negative environmental impact of practicing dermatology” after they read a paper about the environmental impact of endoscopy, written by a gastroenterologist.

In the study, no pregnancies occurred and monthly tests were performed, but “formal assessment of pregnancy risk with virtual isotretinoin management would be warranted,” Dr. Lee and coauthors wrote, noting too that, while no differences were seen with respect to isotretinoin side effects, these were not formally analyzed.

Dr. Zinn said that he and colleagues at WVUH are currently conducting clinical trials to assess the quality and efficacy of virtual care for patients with acne, atopic dermatitis, and psoriasis. Delivering care virtually “will be easier to do if there are data supporting [its] quality and efficacy,” he said. Rosacea is another condition that may be amendable to virtual care, he noted.

Meanwhile, he said, isotretinoin management is “well suited” for virtual visits. When initiating isotretinoin treatment, Dr. Zinn now “proactively inquires” if patients would like to pursue their follow-up visits virtually. “I’ll note that it will save the time and decrease the burden of travel, including the financial cost as well as the environmental cost of travel,” he said, estimating that about half of their management visits are currently virtual.

Asked about the study, Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, said the reduced carbon footprint calculated by the researchers and its downstream health benefits “should be taken into consideration by [dermatology] departments, insurers and policymakers” when making decisions about teledermatology.

While environmental impact is “not something I think most institutions are considering for virtual versus in-person care, they should be. And some are,” said Dr. Rosenbach, a founder and cochair of the American Academy of Dermatology Expert Resource Group for Climate Change and Environmental Issues.

Limitations of the study include the generalizability of the results. The impact of virtual isotretinoin management “may be less in predominantly urban areas” than it is in predominately rural West Virginia, the study authors note. And in the case of West Virginia, travel to a local laboratory and pharmacy offsets some of the environmental benefits for the virtual care, they noted. Such travel wasn’t accounted for in the study, but it was found to be a fraction of travel to the WVU hospital clinic. (Patients traveled a median of 5.8 miles to a lab 2.4 times from March 25 to Dec. 1, 2020.)

Dr. Lee will start his dermatology residency at WVU next year. The study was funded by a grant from the U.S. National Science Foundation. The authors have no relevant conflicts of interest, according to Dr. Lee.

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The environmental impact of virtual isotretinoin management at West Virginia University Hospital (WVUH) in 2020 has been estimated in a new study: A reduction of 5,137 kg of greenhouse gas emissions in carbon dioxide equivalents.

In what they say is “one of the first studies to evaluate the environmental impact of any aspect of dermatology,” the authors of the retrospective cross-sectional study identified patients who had virtual visits for isotretinoin management between March 25 and May 29, 2020, – the period during which all such visits were conducted virtually in keeping with hospital recommendations to minimize the spread of COVID-19.

The investigators, from the department of dermatology and the department of civil and environmental engineering at West Virginia University, Morgantown, then counted the number of virtual visits that occurred during this period and through Dec. 1, 2020, (175 virtual visits), calculated the distance patients would have traveled round-trip had these visits been in-person, and converted miles saved into the environmental impact using U.S. Environmental Protection Agency and Federal Highway Administration data and relevant EPA standards.

Most patients had elected to continue virtual visits after May 29, the point at which patients were given the option to return to the WVUH clinic. (Patients who initiated treatment during the 2-month identification period were not included.)

The investigators determined that virtual management of isotretinoin saved a median of 37.8 miles per visit during the study period of March 25 to Dec. 1, and estimated that the virtual visits reduced total travel by 14,450 miles. For the analysis, patients were assumed to use light-duty vehicles.

In addition to calculating the reduction in emissions during the study period (5,137 kg of CO2equivalents) they used patient census data from 2019 to 2020 and data from the study period to project the mileage – and the associated emissions – that would be saved annually if all in-person visits for isotretinoin management occurred virtually.

Their calculation for a projected emissions reduction with 1 year of all-virtual isotretinoin management was 49,400 kg of greenhouse gas emissions in CO2equivalents. This is the emission load released when 24,690 kg of coal are burned or 6.3 million smartphones are charged, the researchers wrote.

“Considering that more than 1,000,000 prescriptions of isotretinoin are authorized annually in the United States, the environmental impact could be magnified if virtual delivery of isotretinoin care is adopted on a national scale,” they commented.“Given the serious consequences of global climate change, analysis of the environmental impact of all fields of medicine, including dermatology, is warranted,” they added.

The reduced greenhouse gas emissions are “definitely [being taken] into consideration for future decisions about virtual visits” in the department of dermatology, said Zachary Zinn, MD, residency director and associate professor in the department of dermatology at West Virginia University, Morgantown, who is the senior author of the study. “The main benefit of virtual care in my opinion,” he said in an interview, “is the potential to reduce our carbon footprint.”



Justin Lee, MD, an intern at WVU and the study’s first author, said that the research team was motivated to think about how they “could reduce the negative environmental impact of practicing dermatology” after they read a paper about the environmental impact of endoscopy, written by a gastroenterologist.

In the study, no pregnancies occurred and monthly tests were performed, but “formal assessment of pregnancy risk with virtual isotretinoin management would be warranted,” Dr. Lee and coauthors wrote, noting too that, while no differences were seen with respect to isotretinoin side effects, these were not formally analyzed.

Dr. Zinn said that he and colleagues at WVUH are currently conducting clinical trials to assess the quality and efficacy of virtual care for patients with acne, atopic dermatitis, and psoriasis. Delivering care virtually “will be easier to do if there are data supporting [its] quality and efficacy,” he said. Rosacea is another condition that may be amendable to virtual care, he noted.

Meanwhile, he said, isotretinoin management is “well suited” for virtual visits. When initiating isotretinoin treatment, Dr. Zinn now “proactively inquires” if patients would like to pursue their follow-up visits virtually. “I’ll note that it will save the time and decrease the burden of travel, including the financial cost as well as the environmental cost of travel,” he said, estimating that about half of their management visits are currently virtual.

Asked about the study, Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, said the reduced carbon footprint calculated by the researchers and its downstream health benefits “should be taken into consideration by [dermatology] departments, insurers and policymakers” when making decisions about teledermatology.

While environmental impact is “not something I think most institutions are considering for virtual versus in-person care, they should be. And some are,” said Dr. Rosenbach, a founder and cochair of the American Academy of Dermatology Expert Resource Group for Climate Change and Environmental Issues.

Limitations of the study include the generalizability of the results. The impact of virtual isotretinoin management “may be less in predominantly urban areas” than it is in predominately rural West Virginia, the study authors note. And in the case of West Virginia, travel to a local laboratory and pharmacy offsets some of the environmental benefits for the virtual care, they noted. Such travel wasn’t accounted for in the study, but it was found to be a fraction of travel to the WVU hospital clinic. (Patients traveled a median of 5.8 miles to a lab 2.4 times from March 25 to Dec. 1, 2020.)

Dr. Lee will start his dermatology residency at WVU next year. The study was funded by a grant from the U.S. National Science Foundation. The authors have no relevant conflicts of interest, according to Dr. Lee.

The environmental impact of virtual isotretinoin management at West Virginia University Hospital (WVUH) in 2020 has been estimated in a new study: A reduction of 5,137 kg of greenhouse gas emissions in carbon dioxide equivalents.

In what they say is “one of the first studies to evaluate the environmental impact of any aspect of dermatology,” the authors of the retrospective cross-sectional study identified patients who had virtual visits for isotretinoin management between March 25 and May 29, 2020, – the period during which all such visits were conducted virtually in keeping with hospital recommendations to minimize the spread of COVID-19.

The investigators, from the department of dermatology and the department of civil and environmental engineering at West Virginia University, Morgantown, then counted the number of virtual visits that occurred during this period and through Dec. 1, 2020, (175 virtual visits), calculated the distance patients would have traveled round-trip had these visits been in-person, and converted miles saved into the environmental impact using U.S. Environmental Protection Agency and Federal Highway Administration data and relevant EPA standards.

Most patients had elected to continue virtual visits after May 29, the point at which patients were given the option to return to the WVUH clinic. (Patients who initiated treatment during the 2-month identification period were not included.)

The investigators determined that virtual management of isotretinoin saved a median of 37.8 miles per visit during the study period of March 25 to Dec. 1, and estimated that the virtual visits reduced total travel by 14,450 miles. For the analysis, patients were assumed to use light-duty vehicles.

In addition to calculating the reduction in emissions during the study period (5,137 kg of CO2equivalents) they used patient census data from 2019 to 2020 and data from the study period to project the mileage – and the associated emissions – that would be saved annually if all in-person visits for isotretinoin management occurred virtually.

Their calculation for a projected emissions reduction with 1 year of all-virtual isotretinoin management was 49,400 kg of greenhouse gas emissions in CO2equivalents. This is the emission load released when 24,690 kg of coal are burned or 6.3 million smartphones are charged, the researchers wrote.

“Considering that more than 1,000,000 prescriptions of isotretinoin are authorized annually in the United States, the environmental impact could be magnified if virtual delivery of isotretinoin care is adopted on a national scale,” they commented.“Given the serious consequences of global climate change, analysis of the environmental impact of all fields of medicine, including dermatology, is warranted,” they added.

The reduced greenhouse gas emissions are “definitely [being taken] into consideration for future decisions about virtual visits” in the department of dermatology, said Zachary Zinn, MD, residency director and associate professor in the department of dermatology at West Virginia University, Morgantown, who is the senior author of the study. “The main benefit of virtual care in my opinion,” he said in an interview, “is the potential to reduce our carbon footprint.”



Justin Lee, MD, an intern at WVU and the study’s first author, said that the research team was motivated to think about how they “could reduce the negative environmental impact of practicing dermatology” after they read a paper about the environmental impact of endoscopy, written by a gastroenterologist.

In the study, no pregnancies occurred and monthly tests were performed, but “formal assessment of pregnancy risk with virtual isotretinoin management would be warranted,” Dr. Lee and coauthors wrote, noting too that, while no differences were seen with respect to isotretinoin side effects, these were not formally analyzed.

Dr. Zinn said that he and colleagues at WVUH are currently conducting clinical trials to assess the quality and efficacy of virtual care for patients with acne, atopic dermatitis, and psoriasis. Delivering care virtually “will be easier to do if there are data supporting [its] quality and efficacy,” he said. Rosacea is another condition that may be amendable to virtual care, he noted.

Meanwhile, he said, isotretinoin management is “well suited” for virtual visits. When initiating isotretinoin treatment, Dr. Zinn now “proactively inquires” if patients would like to pursue their follow-up visits virtually. “I’ll note that it will save the time and decrease the burden of travel, including the financial cost as well as the environmental cost of travel,” he said, estimating that about half of their management visits are currently virtual.

Asked about the study, Misha Rosenbach, MD, associate professor of dermatology at the University of Pennsylvania, Philadelphia, said the reduced carbon footprint calculated by the researchers and its downstream health benefits “should be taken into consideration by [dermatology] departments, insurers and policymakers” when making decisions about teledermatology.

While environmental impact is “not something I think most institutions are considering for virtual versus in-person care, they should be. And some are,” said Dr. Rosenbach, a founder and cochair of the American Academy of Dermatology Expert Resource Group for Climate Change and Environmental Issues.

Limitations of the study include the generalizability of the results. The impact of virtual isotretinoin management “may be less in predominantly urban areas” than it is in predominately rural West Virginia, the study authors note. And in the case of West Virginia, travel to a local laboratory and pharmacy offsets some of the environmental benefits for the virtual care, they noted. Such travel wasn’t accounted for in the study, but it was found to be a fraction of travel to the WVU hospital clinic. (Patients traveled a median of 5.8 miles to a lab 2.4 times from March 25 to Dec. 1, 2020.)

Dr. Lee will start his dermatology residency at WVU next year. The study was funded by a grant from the U.S. National Science Foundation. The authors have no relevant conflicts of interest, according to Dr. Lee.

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When it comes to young women, regular check-ins support ongoing PrEP use

Article Type
Changed
Tue, 07/27/2021 - 14:16

 

For the first time, an HIV prevention trial that was limited to adolescent girls and young women found that, given sufficient support, girls will use either daily oral pre-exposure prophylaxis (PrEP) or the vaginal dapivirine ring to protect themselves from HIV.

The secret, said Gonasagrie Nair, MBChB, faculty of medicine and health sciences at Stellenbosch University, Zimbabwe, is offering intensive wraparound services to support teenagers – a lesson that may be useful as adolescent and family medicine professionals in the United States begin to roll out HIV prevention in their clinics.

This is important in the United States because cisgender Black women make up 60% of all new HIV cases in the United States while accounting for just 14% of the overall U.S. population. The Centers for Disease Control and Prevention has found that only about 1% of Black Americans who could benefit from PrEP have access to it.

“Younger women and adolescent girls in particular face a number of cultural and social challenges that impact their ability to make decisions related to their own health,” said Dr. Nair, who presented the data at the International AIDS Society (IAS) Conference 2021. “The adherence support provided by this study empowered them to make choices and stick to these choices,” she said.

In total, 247 women and girls aged 16 to 21 who were without HIV were enrolled in the Reversing the Epidemic in Africa with Choices in HIV Prevention (REACH) trial in two sites in South Africa and one each in Uganda and Zimbabwe beginning in February 2019. One-third of the participants were minors; the average age was 18.2 years.

The women were good candidates for PrEP. More than 1 in 3 of the women started the study with a sexually transmitted infection (STI), the most prevalent of which was chlamydia. This is often a good marker for condomless sex. Of the participants, 89% had a primary sex partner; a quarter of those thought their partner was having sex with other people. Only 7% of participants reported being very worried about acquiring HIV. More than 1 in 3 (39%) weren’t worried about HIV at all. This conforms to previous data suggesting that those who could most benefit from PrEP often don’t perceive their own vulnerability.

In the study, the women were randomly assigned two groups. In one group, the participants used the dapivirine ring for 6 months; in the other, participants used oral PrEP for 6 months. The participants then swapped prevention methods and used the alternative method for 6 more months. After a year of trying both methods, the women will be asked to choose one of the two prevention method or to stop PrEP altogether. At the IAS conference, the researchers reported interim data from the first year of the study, before the girls had the opportunity to choose for themselves.

During that first year, girls received intensive adherence support, including daily or weekly text check-ins, phone check-ins, peer buddy support, additional onsite counseling visits, access to adherence support groups, participation in online support groups via apps such as WhatsApp, and in-person social events designed to empower young women and to teach them skills. Support included discussion of adherence, contraceptives, and STIs. In addition, when girls came in for study visits, staff provided feedback on how adherent the girls had been, as determined on the basis of residual levels of dapivirine in the rings or, with regard to oral pills, drug levels as determined with blood spots.

Girls were considered to have had high adherence if they were found to have oral PrEP concentrations equivalent to four or more doses per week or if residual levels of dapivirine in their rings were 0.1071 mg/d. Moderate adherence was the equivalent of one to three doses of oral PrEP a week or dapivirine levels between 0.0321 mg/d and 0.1071 mg/d.

In total, 95.6% of ring users showed some adherence to the ring. Of those, adherence was high for 50.2%; 49.8% used the ring perfectly. For oral PrEP, 98.5% showed some level of PrEP use; for 58.6%, lab results suggested adherence high enough to provide protection from HIV, and 22% took their pills at least six times a week. Between the two arms, 54.3% of all participants used the medication sufficiently to be protected from HIV.

One person acquired HIV during the study. Dr. Nair did not say which study arm that participant was in or how adherent that person has been to their prevention method.

That level of adherence is on par with studies in the United States, which have found 56% adherence to PrEP among adolescent and young men who have sex with men. But the level of adherence is far higher than has been found in other studies that tested oral PrEP among women who did not have a partner with HIV. In particular, the VOICE and FEM-PrEP trials were both stopped early for lack of adherence. In those placebo-controlled oral-PrEP trials, fewer than 25% of participants used the oral prevention pills. Although adherence to the vaginal ring was estimated to be 61% for women older than 25 in the ASPIRE trial, it was effectively zero among women aged 18 to 21 years. Adherence has been the “bugaboo of efficacy for PrEP in young women,” said Judith Auerbach, PhD, independent science and policy consultant and professor of medicine at the University of California, San Francisco. But health care professionals have a long way to go to support young people in general in using PrEP.

“Yes, this shows improvement compared to previous studies,” Dr. Auerbach told this news organization. “But is it sufficient to have an epidemiological impact at the population level?”

Medical Advocacy and Outreach (MAO) is an HIV clinic and services program in Montgomery, Alabama, that offers a clinic specifically for some of their 144 clients to receive oral PrEP. In addition to in-person testing, MAO offers home HIV testing and lab work and televisits to support the college students they serve in taking PrEP whether they’re at school or at home on break. Currently, MAO provides a series of support groups and other social support programs for their clients living with HIV, but there are none for those receiving PrEP. The organization is in the process of hiring a social worker for the PrEP side of the clinic.

Until that person is on board, “I’m their support system in an unofficial capacity,” Shericka Williams, MPH, told this news organization. She runs education programs at MAO and handles all the phone calls from PrEP clients. “My title changes a lot, but the one I like to go with most often is the PrEP navigator,” she said.

She said she was intrigued by the dapivirine ring and oral PrEP data but said that currently, the women they serve are still learning that PrEP is for them, too. The women report that all the ads and all the information they receive is aimed at gay or bisexual men or transgender women. It takes a while for them to recognize that they could benefit, so a lot of the work that Ms. Williams does is focused on explaining the benefit of PrEP.

In MAO, the number of women receiving PrEP fluctuates more than for men. Mostly, women start PrEP because of they are in a relationship with someone who receives HIV care from MAO’s other wing – women who potentially would experience less vulnerability to HIV if their partners had undetectable viral loads. The other reason women take it is because they suspect that their partner is cheating or because they are in abusive relationships in which they want their partner to use a condom but the partner won’t. As in the PrEP trials, they often see women discontinue PrEP when they leave those relationships. In part, her job is to educate women regarding all the ways PrEP could serve them.

“Most of the time, they’re just no longer in that relationship, and they’re just taking some time for themselves,” she said in an interview. “We definitely try to bring up other reasons to stay on PrEP, but we don’t want to seem like we’re bullying someone to stay on it.”

Dr. Nair, Dr. Auerbach, and Ms. Williams report no relevant financial relationships.

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

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For the first time, an HIV prevention trial that was limited to adolescent girls and young women found that, given sufficient support, girls will use either daily oral pre-exposure prophylaxis (PrEP) or the vaginal dapivirine ring to protect themselves from HIV.

The secret, said Gonasagrie Nair, MBChB, faculty of medicine and health sciences at Stellenbosch University, Zimbabwe, is offering intensive wraparound services to support teenagers – a lesson that may be useful as adolescent and family medicine professionals in the United States begin to roll out HIV prevention in their clinics.

This is important in the United States because cisgender Black women make up 60% of all new HIV cases in the United States while accounting for just 14% of the overall U.S. population. The Centers for Disease Control and Prevention has found that only about 1% of Black Americans who could benefit from PrEP have access to it.

“Younger women and adolescent girls in particular face a number of cultural and social challenges that impact their ability to make decisions related to their own health,” said Dr. Nair, who presented the data at the International AIDS Society (IAS) Conference 2021. “The adherence support provided by this study empowered them to make choices and stick to these choices,” she said.

In total, 247 women and girls aged 16 to 21 who were without HIV were enrolled in the Reversing the Epidemic in Africa with Choices in HIV Prevention (REACH) trial in two sites in South Africa and one each in Uganda and Zimbabwe beginning in February 2019. One-third of the participants were minors; the average age was 18.2 years.

The women were good candidates for PrEP. More than 1 in 3 of the women started the study with a sexually transmitted infection (STI), the most prevalent of which was chlamydia. This is often a good marker for condomless sex. Of the participants, 89% had a primary sex partner; a quarter of those thought their partner was having sex with other people. Only 7% of participants reported being very worried about acquiring HIV. More than 1 in 3 (39%) weren’t worried about HIV at all. This conforms to previous data suggesting that those who could most benefit from PrEP often don’t perceive their own vulnerability.

In the study, the women were randomly assigned two groups. In one group, the participants used the dapivirine ring for 6 months; in the other, participants used oral PrEP for 6 months. The participants then swapped prevention methods and used the alternative method for 6 more months. After a year of trying both methods, the women will be asked to choose one of the two prevention method or to stop PrEP altogether. At the IAS conference, the researchers reported interim data from the first year of the study, before the girls had the opportunity to choose for themselves.

During that first year, girls received intensive adherence support, including daily or weekly text check-ins, phone check-ins, peer buddy support, additional onsite counseling visits, access to adherence support groups, participation in online support groups via apps such as WhatsApp, and in-person social events designed to empower young women and to teach them skills. Support included discussion of adherence, contraceptives, and STIs. In addition, when girls came in for study visits, staff provided feedback on how adherent the girls had been, as determined on the basis of residual levels of dapivirine in the rings or, with regard to oral pills, drug levels as determined with blood spots.

Girls were considered to have had high adherence if they were found to have oral PrEP concentrations equivalent to four or more doses per week or if residual levels of dapivirine in their rings were 0.1071 mg/d. Moderate adherence was the equivalent of one to three doses of oral PrEP a week or dapivirine levels between 0.0321 mg/d and 0.1071 mg/d.

In total, 95.6% of ring users showed some adherence to the ring. Of those, adherence was high for 50.2%; 49.8% used the ring perfectly. For oral PrEP, 98.5% showed some level of PrEP use; for 58.6%, lab results suggested adherence high enough to provide protection from HIV, and 22% took their pills at least six times a week. Between the two arms, 54.3% of all participants used the medication sufficiently to be protected from HIV.

One person acquired HIV during the study. Dr. Nair did not say which study arm that participant was in or how adherent that person has been to their prevention method.

That level of adherence is on par with studies in the United States, which have found 56% adherence to PrEP among adolescent and young men who have sex with men. But the level of adherence is far higher than has been found in other studies that tested oral PrEP among women who did not have a partner with HIV. In particular, the VOICE and FEM-PrEP trials were both stopped early for lack of adherence. In those placebo-controlled oral-PrEP trials, fewer than 25% of participants used the oral prevention pills. Although adherence to the vaginal ring was estimated to be 61% for women older than 25 in the ASPIRE trial, it was effectively zero among women aged 18 to 21 years. Adherence has been the “bugaboo of efficacy for PrEP in young women,” said Judith Auerbach, PhD, independent science and policy consultant and professor of medicine at the University of California, San Francisco. But health care professionals have a long way to go to support young people in general in using PrEP.

“Yes, this shows improvement compared to previous studies,” Dr. Auerbach told this news organization. “But is it sufficient to have an epidemiological impact at the population level?”

Medical Advocacy and Outreach (MAO) is an HIV clinic and services program in Montgomery, Alabama, that offers a clinic specifically for some of their 144 clients to receive oral PrEP. In addition to in-person testing, MAO offers home HIV testing and lab work and televisits to support the college students they serve in taking PrEP whether they’re at school or at home on break. Currently, MAO provides a series of support groups and other social support programs for their clients living with HIV, but there are none for those receiving PrEP. The organization is in the process of hiring a social worker for the PrEP side of the clinic.

Until that person is on board, “I’m their support system in an unofficial capacity,” Shericka Williams, MPH, told this news organization. She runs education programs at MAO and handles all the phone calls from PrEP clients. “My title changes a lot, but the one I like to go with most often is the PrEP navigator,” she said.

She said she was intrigued by the dapivirine ring and oral PrEP data but said that currently, the women they serve are still learning that PrEP is for them, too. The women report that all the ads and all the information they receive is aimed at gay or bisexual men or transgender women. It takes a while for them to recognize that they could benefit, so a lot of the work that Ms. Williams does is focused on explaining the benefit of PrEP.

In MAO, the number of women receiving PrEP fluctuates more than for men. Mostly, women start PrEP because of they are in a relationship with someone who receives HIV care from MAO’s other wing – women who potentially would experience less vulnerability to HIV if their partners had undetectable viral loads. The other reason women take it is because they suspect that their partner is cheating or because they are in abusive relationships in which they want their partner to use a condom but the partner won’t. As in the PrEP trials, they often see women discontinue PrEP when they leave those relationships. In part, her job is to educate women regarding all the ways PrEP could serve them.

“Most of the time, they’re just no longer in that relationship, and they’re just taking some time for themselves,” she said in an interview. “We definitely try to bring up other reasons to stay on PrEP, but we don’t want to seem like we’re bullying someone to stay on it.”

Dr. Nair, Dr. Auerbach, and Ms. Williams report no relevant financial relationships.

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

 

For the first time, an HIV prevention trial that was limited to adolescent girls and young women found that, given sufficient support, girls will use either daily oral pre-exposure prophylaxis (PrEP) or the vaginal dapivirine ring to protect themselves from HIV.

The secret, said Gonasagrie Nair, MBChB, faculty of medicine and health sciences at Stellenbosch University, Zimbabwe, is offering intensive wraparound services to support teenagers – a lesson that may be useful as adolescent and family medicine professionals in the United States begin to roll out HIV prevention in their clinics.

This is important in the United States because cisgender Black women make up 60% of all new HIV cases in the United States while accounting for just 14% of the overall U.S. population. The Centers for Disease Control and Prevention has found that only about 1% of Black Americans who could benefit from PrEP have access to it.

“Younger women and adolescent girls in particular face a number of cultural and social challenges that impact their ability to make decisions related to their own health,” said Dr. Nair, who presented the data at the International AIDS Society (IAS) Conference 2021. “The adherence support provided by this study empowered them to make choices and stick to these choices,” she said.

In total, 247 women and girls aged 16 to 21 who were without HIV were enrolled in the Reversing the Epidemic in Africa with Choices in HIV Prevention (REACH) trial in two sites in South Africa and one each in Uganda and Zimbabwe beginning in February 2019. One-third of the participants were minors; the average age was 18.2 years.

The women were good candidates for PrEP. More than 1 in 3 of the women started the study with a sexually transmitted infection (STI), the most prevalent of which was chlamydia. This is often a good marker for condomless sex. Of the participants, 89% had a primary sex partner; a quarter of those thought their partner was having sex with other people. Only 7% of participants reported being very worried about acquiring HIV. More than 1 in 3 (39%) weren’t worried about HIV at all. This conforms to previous data suggesting that those who could most benefit from PrEP often don’t perceive their own vulnerability.

In the study, the women were randomly assigned two groups. In one group, the participants used the dapivirine ring for 6 months; in the other, participants used oral PrEP for 6 months. The participants then swapped prevention methods and used the alternative method for 6 more months. After a year of trying both methods, the women will be asked to choose one of the two prevention method or to stop PrEP altogether. At the IAS conference, the researchers reported interim data from the first year of the study, before the girls had the opportunity to choose for themselves.

During that first year, girls received intensive adherence support, including daily or weekly text check-ins, phone check-ins, peer buddy support, additional onsite counseling visits, access to adherence support groups, participation in online support groups via apps such as WhatsApp, and in-person social events designed to empower young women and to teach them skills. Support included discussion of adherence, contraceptives, and STIs. In addition, when girls came in for study visits, staff provided feedback on how adherent the girls had been, as determined on the basis of residual levels of dapivirine in the rings or, with regard to oral pills, drug levels as determined with blood spots.

Girls were considered to have had high adherence if they were found to have oral PrEP concentrations equivalent to four or more doses per week or if residual levels of dapivirine in their rings were 0.1071 mg/d. Moderate adherence was the equivalent of one to three doses of oral PrEP a week or dapivirine levels between 0.0321 mg/d and 0.1071 mg/d.

In total, 95.6% of ring users showed some adherence to the ring. Of those, adherence was high for 50.2%; 49.8% used the ring perfectly. For oral PrEP, 98.5% showed some level of PrEP use; for 58.6%, lab results suggested adherence high enough to provide protection from HIV, and 22% took their pills at least six times a week. Between the two arms, 54.3% of all participants used the medication sufficiently to be protected from HIV.

One person acquired HIV during the study. Dr. Nair did not say which study arm that participant was in or how adherent that person has been to their prevention method.

That level of adherence is on par with studies in the United States, which have found 56% adherence to PrEP among adolescent and young men who have sex with men. But the level of adherence is far higher than has been found in other studies that tested oral PrEP among women who did not have a partner with HIV. In particular, the VOICE and FEM-PrEP trials were both stopped early for lack of adherence. In those placebo-controlled oral-PrEP trials, fewer than 25% of participants used the oral prevention pills. Although adherence to the vaginal ring was estimated to be 61% for women older than 25 in the ASPIRE trial, it was effectively zero among women aged 18 to 21 years. Adherence has been the “bugaboo of efficacy for PrEP in young women,” said Judith Auerbach, PhD, independent science and policy consultant and professor of medicine at the University of California, San Francisco. But health care professionals have a long way to go to support young people in general in using PrEP.

“Yes, this shows improvement compared to previous studies,” Dr. Auerbach told this news organization. “But is it sufficient to have an epidemiological impact at the population level?”

Medical Advocacy and Outreach (MAO) is an HIV clinic and services program in Montgomery, Alabama, that offers a clinic specifically for some of their 144 clients to receive oral PrEP. In addition to in-person testing, MAO offers home HIV testing and lab work and televisits to support the college students they serve in taking PrEP whether they’re at school or at home on break. Currently, MAO provides a series of support groups and other social support programs for their clients living with HIV, but there are none for those receiving PrEP. The organization is in the process of hiring a social worker for the PrEP side of the clinic.

Until that person is on board, “I’m their support system in an unofficial capacity,” Shericka Williams, MPH, told this news organization. She runs education programs at MAO and handles all the phone calls from PrEP clients. “My title changes a lot, but the one I like to go with most often is the PrEP navigator,” she said.

She said she was intrigued by the dapivirine ring and oral PrEP data but said that currently, the women they serve are still learning that PrEP is for them, too. The women report that all the ads and all the information they receive is aimed at gay or bisexual men or transgender women. It takes a while for them to recognize that they could benefit, so a lot of the work that Ms. Williams does is focused on explaining the benefit of PrEP.

In MAO, the number of women receiving PrEP fluctuates more than for men. Mostly, women start PrEP because of they are in a relationship with someone who receives HIV care from MAO’s other wing – women who potentially would experience less vulnerability to HIV if their partners had undetectable viral loads. The other reason women take it is because they suspect that their partner is cheating or because they are in abusive relationships in which they want their partner to use a condom but the partner won’t. As in the PrEP trials, they often see women discontinue PrEP when they leave those relationships. In part, her job is to educate women regarding all the ways PrEP could serve them.

“Most of the time, they’re just no longer in that relationship, and they’re just taking some time for themselves,” she said in an interview. “We definitely try to bring up other reasons to stay on PrEP, but we don’t want to seem like we’re bullying someone to stay on it.”

Dr. Nair, Dr. Auerbach, and Ms. Williams report no relevant financial relationships.

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

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Strong support for causal role of cannabis in schizophrenia

Article Type
Changed
Fri, 11/19/2021 - 08:58

 

The long-observed association between cannabis use and schizophrenia is likely partially causal in nature, new research shows.

Investigators found a clear increase in the proportion of schizophrenia cases linked to cannabis use disorder over the past 25 years.

“In my view, the association is most likely causative, at least to a large extent,” first author Carsten Hjorthøj, PhD, from the Copenhagen Research Center for Mental Health, Copenhagen University Hospital, told this news organization.

“It is, of course, nearly impossible to use epidemiological studies to actually prove causation, but all the numbers behave exactly in the way that would be expected under the theory of causation,” said Dr. Hjorthøj.

The study was published online July 21 in JAMA Psychiatry.
 

Far from harmless

The findings are based on Danish national health registry data. The study sample included all people in Denmark born before Dec. 31, 2000 who were aged 16 years or older at some point from Jan. 1, 1972 to Dec. 31, 2016. The data analysis was conducted from August 2020 to April 2021.

Despite some fluctuation, there was a general increase in the population-attributable risk fraction (PARF) for cannabis use disorder with regard to schizophrenia over time, the researchers report. The PARF increased from about 2% in 1995 to about 4% in 2000 and has hovered from 6% to 8% since 2010.

“Although not in itself proof of causality, our study provides evidence of the theory of cannabis being a component cause of schizophrenia,” the investigators write.

The findings are “particularly important with the increasing legalization of cannabis for both medicinal and recreational uses seeming to lead to an increase in the perception of cannabis as relatively harmless and possibly in the uptake of cannabis use, especially among youth,” they add.

“Although psychosis is not the only outcome of interest in terms of cannabis use, our study clearly indicates that cannabis should not be considered harmless,” they conclude.
 

Cases linked to cannabis underestimated?

In an accompanying editorial, Tyler VanderWeele, PhD, Harvard School of Public Health, Boston, notes that estimates in this study could be conservative as a result of underdiagnosis of cannabis use disorder and because it only examined cannabis use disorder.

“Cannabis use disorder is not responsible for most schizophrenia cases, but it is responsible for a nonnegligible and increasing proportion. This should be considered in discussions regarding legalization and regulation of the use of cannabis,” Dr. VanderWeele writes.

Experts with the Science Media Center, a U.K. nonprofit organization, also weighed in on the results.

Terrie Moffitt, PhD, with King’s College London, said the study “adds important evidence that patients with diagnosed cannabis use disorder are more at risk for psychosis now than they used to be.”

A study weakness that readers will spot right away is that the study reported on patients who had a clinical diagnosis of cannabis dependence. However, most cannabis users, even those who are dependent on it, never come in to clinics for treatment. Also, it is known that people who seek treatment tend to have multiple mental health problems, not solely cannabis problems,” Dr. Moffitt commented.

Emir Englund, PhD, also from King’s College London, said the study “strengthens an already well-established association between the two. However, it is unable to shed additional light on whether cannabis causes schizophrenia or not, due to the observational nature of the study.”

“In my opinion, the current scientific view of cannabis use as a ‘component cause’ which interacts with other risk factors to cause schizophrenia but is neither necessary nor sufficient to do so on its own still stands,” Dr. Englund said.

The study was supported by a grant from Lundbeckfonden. The authors have disclosed no relevant financial relationships. Dr. VanderWeele has received grants from the National Cancer Institute and the John Templeton Foundation. Dr. Moffitt and Dr. Englund have disclosed no relevant financial relationships.

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

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The long-observed association between cannabis use and schizophrenia is likely partially causal in nature, new research shows.

Investigators found a clear increase in the proportion of schizophrenia cases linked to cannabis use disorder over the past 25 years.

“In my view, the association is most likely causative, at least to a large extent,” first author Carsten Hjorthøj, PhD, from the Copenhagen Research Center for Mental Health, Copenhagen University Hospital, told this news organization.

“It is, of course, nearly impossible to use epidemiological studies to actually prove causation, but all the numbers behave exactly in the way that would be expected under the theory of causation,” said Dr. Hjorthøj.

The study was published online July 21 in JAMA Psychiatry.
 

Far from harmless

The findings are based on Danish national health registry data. The study sample included all people in Denmark born before Dec. 31, 2000 who were aged 16 years or older at some point from Jan. 1, 1972 to Dec. 31, 2016. The data analysis was conducted from August 2020 to April 2021.

Despite some fluctuation, there was a general increase in the population-attributable risk fraction (PARF) for cannabis use disorder with regard to schizophrenia over time, the researchers report. The PARF increased from about 2% in 1995 to about 4% in 2000 and has hovered from 6% to 8% since 2010.

“Although not in itself proof of causality, our study provides evidence of the theory of cannabis being a component cause of schizophrenia,” the investigators write.

The findings are “particularly important with the increasing legalization of cannabis for both medicinal and recreational uses seeming to lead to an increase in the perception of cannabis as relatively harmless and possibly in the uptake of cannabis use, especially among youth,” they add.

“Although psychosis is not the only outcome of interest in terms of cannabis use, our study clearly indicates that cannabis should not be considered harmless,” they conclude.
 

Cases linked to cannabis underestimated?

In an accompanying editorial, Tyler VanderWeele, PhD, Harvard School of Public Health, Boston, notes that estimates in this study could be conservative as a result of underdiagnosis of cannabis use disorder and because it only examined cannabis use disorder.

“Cannabis use disorder is not responsible for most schizophrenia cases, but it is responsible for a nonnegligible and increasing proportion. This should be considered in discussions regarding legalization and regulation of the use of cannabis,” Dr. VanderWeele writes.

Experts with the Science Media Center, a U.K. nonprofit organization, also weighed in on the results.

Terrie Moffitt, PhD, with King’s College London, said the study “adds important evidence that patients with diagnosed cannabis use disorder are more at risk for psychosis now than they used to be.”

A study weakness that readers will spot right away is that the study reported on patients who had a clinical diagnosis of cannabis dependence. However, most cannabis users, even those who are dependent on it, never come in to clinics for treatment. Also, it is known that people who seek treatment tend to have multiple mental health problems, not solely cannabis problems,” Dr. Moffitt commented.

Emir Englund, PhD, also from King’s College London, said the study “strengthens an already well-established association between the two. However, it is unable to shed additional light on whether cannabis causes schizophrenia or not, due to the observational nature of the study.”

“In my opinion, the current scientific view of cannabis use as a ‘component cause’ which interacts with other risk factors to cause schizophrenia but is neither necessary nor sufficient to do so on its own still stands,” Dr. Englund said.

The study was supported by a grant from Lundbeckfonden. The authors have disclosed no relevant financial relationships. Dr. VanderWeele has received grants from the National Cancer Institute and the John Templeton Foundation. Dr. Moffitt and Dr. Englund have disclosed no relevant financial relationships.

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

 

The long-observed association between cannabis use and schizophrenia is likely partially causal in nature, new research shows.

Investigators found a clear increase in the proportion of schizophrenia cases linked to cannabis use disorder over the past 25 years.

“In my view, the association is most likely causative, at least to a large extent,” first author Carsten Hjorthøj, PhD, from the Copenhagen Research Center for Mental Health, Copenhagen University Hospital, told this news organization.

“It is, of course, nearly impossible to use epidemiological studies to actually prove causation, but all the numbers behave exactly in the way that would be expected under the theory of causation,” said Dr. Hjorthøj.

The study was published online July 21 in JAMA Psychiatry.
 

Far from harmless

The findings are based on Danish national health registry data. The study sample included all people in Denmark born before Dec. 31, 2000 who were aged 16 years or older at some point from Jan. 1, 1972 to Dec. 31, 2016. The data analysis was conducted from August 2020 to April 2021.

Despite some fluctuation, there was a general increase in the population-attributable risk fraction (PARF) for cannabis use disorder with regard to schizophrenia over time, the researchers report. The PARF increased from about 2% in 1995 to about 4% in 2000 and has hovered from 6% to 8% since 2010.

“Although not in itself proof of causality, our study provides evidence of the theory of cannabis being a component cause of schizophrenia,” the investigators write.

The findings are “particularly important with the increasing legalization of cannabis for both medicinal and recreational uses seeming to lead to an increase in the perception of cannabis as relatively harmless and possibly in the uptake of cannabis use, especially among youth,” they add.

“Although psychosis is not the only outcome of interest in terms of cannabis use, our study clearly indicates that cannabis should not be considered harmless,” they conclude.
 

Cases linked to cannabis underestimated?

In an accompanying editorial, Tyler VanderWeele, PhD, Harvard School of Public Health, Boston, notes that estimates in this study could be conservative as a result of underdiagnosis of cannabis use disorder and because it only examined cannabis use disorder.

“Cannabis use disorder is not responsible for most schizophrenia cases, but it is responsible for a nonnegligible and increasing proportion. This should be considered in discussions regarding legalization and regulation of the use of cannabis,” Dr. VanderWeele writes.

Experts with the Science Media Center, a U.K. nonprofit organization, also weighed in on the results.

Terrie Moffitt, PhD, with King’s College London, said the study “adds important evidence that patients with diagnosed cannabis use disorder are more at risk for psychosis now than they used to be.”

A study weakness that readers will spot right away is that the study reported on patients who had a clinical diagnosis of cannabis dependence. However, most cannabis users, even those who are dependent on it, never come in to clinics for treatment. Also, it is known that people who seek treatment tend to have multiple mental health problems, not solely cannabis problems,” Dr. Moffitt commented.

Emir Englund, PhD, also from King’s College London, said the study “strengthens an already well-established association between the two. However, it is unable to shed additional light on whether cannabis causes schizophrenia or not, due to the observational nature of the study.”

“In my opinion, the current scientific view of cannabis use as a ‘component cause’ which interacts with other risk factors to cause schizophrenia but is neither necessary nor sufficient to do so on its own still stands,” Dr. Englund said.

The study was supported by a grant from Lundbeckfonden. The authors have disclosed no relevant financial relationships. Dr. VanderWeele has received grants from the National Cancer Institute and the John Templeton Foundation. Dr. Moffitt and Dr. Englund have disclosed no relevant financial relationships.

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

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Admissions for eating disorders double in pandemic

Article Type
Changed
Thu, 07/15/2021 - 14:48

 

Medical admissions for adolescents with restrictive eating disorders more than doubled at one hospital during the first 12 months of the COVID-19 pandemic, relative to the average number of admissions in prior years, a new study shows.

Doctors are seeing similar increases across the United States and in other countries.

Providers and health care systems “may need to rapidly adapt in response to increasing demands for care during the COVID-19 pandemic,” the researchers said in their study, which was published online in Pediatrics.

To assess whether admission patterns among adolescents with restrictive eating disorders changed during the pandemic, Alana K. Otto, MD, MPH, with the division of adolescent medicine at the University of Michigan, Ann Arbor, and colleagues reviewed the charts of patients admitted to C.S. Mott Children’s Hospital, also in Ann Arbor.

Their analysis included 297 admissions among 248 patients aged 10-23 years between March 1, 2017, and March 31, 2021. Patients had an average age of about 15 years. Approximately 90% were female, and most had a diagnosis of anorexia nervosa or atypical anorexia nervosa.

Indications for medical admission included physiological instability (for example, heart rate less than 50 beats per minute while awake or blood pressure less than 90/40 mm Hg), electrolyte derangements, and acute medical complications of malnutrition such as syncope. Other possible indications included uncontrolled purging, body mass index less than 75% of the median for age and sex, acute food refusal, and failure of outpatient treatment.

Eating disorder–related admissions per month were stable prior to the pandemic. Admissions then decreased in April 2020, but subsequently increased significantly throughout the study period. In all, there were 125 admissions between April 1, 2020, and March 31, 2021. During the previous 3 years, the average number of admissions per year was 56.

Patients’ insurance status was one factor that differed before and during the pandemic. Prepandemic, about 20% of admissions were for adolescents with public insurance. During the pandemic, however, the proportion with public insurance was approximately 9%, the researchers noted. Other characteristics were generally similar.

The study was retrospective and relatively small and only looked at patients with restrictive eating disorders who were severely ill and admitted for medical stabilization. It does not reflect adolescents with eating disorders in different settings, the authors noted.

Primary care pediatricians should be familiar with indications for medical admission, such as severe bradycardia, as outlined by the Society for Adolescent Health and Medicine, they said.
 

Consistent trends

Unfortunately, the trend seems consistent across the nation, said Michaela M. Voss, MD, director of the the Eating Disorders Center at Children’s Mercy in Kansas City, Mo. “Our outpatient setting went from availability to get in immediately to a 6-month wait list.”

As in Michigan, Dr. Voss noted a drop in admissions as lockdowns started, followed by a spike in treatment demand that has not let up.

Dr. Voss described two of the more common presentations. In one, parents might note that their child had been getting into healthy eating and exercise before the pandemic and seemed fine. “But then COVID came, the lockdown happened, and they became overly obsessed with those things,” Dr. Voss said.

In the other presentation, kids with anxiety, depression, or OCD who lost access to their usual coping strategies and outlets developed eating disorders during the pandemic. “They focused on one of the few things they could during the lockdown, which was their own body, and then their anxiety, depression, [obsessive-compulsive disorder], and other mental health comorbidities presented as an eating disorder,” Dr. Voss said.

The increasing need for treatment over the course of the pandemic may reflect the time that it has taken for the disorders to develop, as well as the time that it takes parents to recognize the problem.

Not only are doctors seeing more cases, but patients are arriving sicker than usual, Dr. Voss said.

Major medical concerns for patients in starvation mode center on the heart, brain, and bones. In addition, refeeding syndrome poses an extreme risk, Dr. Voss noted.

The Academy for Eating Disorders has created a guide to help doctors recognize and manage risks for patients with eating disorders, which may be useful for primary care providers while they are trying to get a patient into more intensive treatment, Dr. Voss suggested. The American Academy of Pediatrics recently published a clinical report on the identification and management of eating disorders in children and adolescents.

Dr. Jennifer Leah Goetz

At Johns Hopkins Hospital Children’s Center in Baltimore, “we have seen a pretty remarkable increase in the number of eating disorders in the child and adolescent space since COVID,” said Jennifer Leah Goetz, MD, a psychiatrist and medical director of the child and adolescent inpatient unit. “We have seen increasing numbers of kids presenting for acute medical stabilization and refeeding and for specific treatment for the eating disorder.”

It could be that, for people with a genetic predisposition to eating disorders, a confluence of factors related to the pandemic unmasked it. For example, children may have spent more time looking at themselves on virtual meeting platforms, which could stir lingering body image and appearance-related concerns in those who are vulnerable. And some teens who were not able to participate in athletics as usual started to watch what they eat more closely, Dr. Goetz said.
 

 

 

A treatment bottleneck

Patients with eating disorders “can be quite ill from a psychiatric and general medical perspective,” Dr. Goetz said. “Most psychiatrists are not particularly comfortable with the medical complications, and most internists or pediatricians are not particularly comfortable with the psychiatric complications. You end up with a patient population that can only see a really highly specialized group of individuals for care. And it is a problem. It was a problem before the pandemic, and it has been really exacerbated by what we have been going through with COVID.”

Dr. Natalie Muth

Natalie Muth, MD, MPH, RDN, a pediatrician at Children’s Primary Care Medical Group La Costa in Carlsbad, Calif., has also noticed the increase in eating disorders since COVID.

In-patient colleagues “have longer wait lists and more severe cases than they have ever seen previously,” said Dr. Muth, who chairs the American Academy of Pediatrics Section on Obesity and is an adjunct assistant professor at the University of California, Los Angeles. “In primary care, we are all having to better educate and prepare ourselves for identifying and managing patients with eating disorders.”

That could mean connecting with mental health professionals, registered dietitians, and higher levels of care. But that may be a challenge. “Accessing these resources has been more difficult due to the increasing incidence of eating disorders recently,” Dr. Muth said.

Dr. Voss acknowledged that childhood obesity is another concern for pediatricians. “However, there are appropriate and healthy and safe ways to address that,” she said. A patient with overweight or obesity who loses weight may not be doing so in a healthy way.

Clinicians should wonder if a patient’s weight is decreasing too fast. And they should ask patients questions that could help identify a problem, such as: What are they doing to cause the weight loss? Why do they want to lose the weight?

Dr. Voss added that eating disorders “do not discriminate.” While there may be a perception that all patients with eating disorders are White, upper middle–class females who are thin, “that is not the case,” Dr. Voss said. They “come in all genders, all races, all weight classes, and all ages,” she said, “and we see that variety.”

In general, there may be a need to shift how weight is discussed in clinics and society more broadly, Dr. Goetz said. Weight is an incredibly personal thing, and everyone’s genetics, metabolism, and life circumstances vary. At the same time, body mass index is not necessarily the best measure of a person’s health.

Asking a child, teen, or even an adult to go on a diet is not a benign intervention, Dr. Goetz noted. In addition, dieting is unlikely to help in the long term.

Emerging from lockdown, pressure to lose “COVID pounds” is a dangerous message for people with eating disorders, Dr. Goetz said. It also could be a dangerous message for people without eating disorders. “There are so many more interesting things about each one of us than our weight,” she added.

The study authors, Dr. Voss, Dr. Goetz, and Dr. Muth had no relevant disclosures.

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Medical admissions for adolescents with restrictive eating disorders more than doubled at one hospital during the first 12 months of the COVID-19 pandemic, relative to the average number of admissions in prior years, a new study shows.

Doctors are seeing similar increases across the United States and in other countries.

Providers and health care systems “may need to rapidly adapt in response to increasing demands for care during the COVID-19 pandemic,” the researchers said in their study, which was published online in Pediatrics.

To assess whether admission patterns among adolescents with restrictive eating disorders changed during the pandemic, Alana K. Otto, MD, MPH, with the division of adolescent medicine at the University of Michigan, Ann Arbor, and colleagues reviewed the charts of patients admitted to C.S. Mott Children’s Hospital, also in Ann Arbor.

Their analysis included 297 admissions among 248 patients aged 10-23 years between March 1, 2017, and March 31, 2021. Patients had an average age of about 15 years. Approximately 90% were female, and most had a diagnosis of anorexia nervosa or atypical anorexia nervosa.

Indications for medical admission included physiological instability (for example, heart rate less than 50 beats per minute while awake or blood pressure less than 90/40 mm Hg), electrolyte derangements, and acute medical complications of malnutrition such as syncope. Other possible indications included uncontrolled purging, body mass index less than 75% of the median for age and sex, acute food refusal, and failure of outpatient treatment.

Eating disorder–related admissions per month were stable prior to the pandemic. Admissions then decreased in April 2020, but subsequently increased significantly throughout the study period. In all, there were 125 admissions between April 1, 2020, and March 31, 2021. During the previous 3 years, the average number of admissions per year was 56.

Patients’ insurance status was one factor that differed before and during the pandemic. Prepandemic, about 20% of admissions were for adolescents with public insurance. During the pandemic, however, the proportion with public insurance was approximately 9%, the researchers noted. Other characteristics were generally similar.

The study was retrospective and relatively small and only looked at patients with restrictive eating disorders who were severely ill and admitted for medical stabilization. It does not reflect adolescents with eating disorders in different settings, the authors noted.

Primary care pediatricians should be familiar with indications for medical admission, such as severe bradycardia, as outlined by the Society for Adolescent Health and Medicine, they said.
 

Consistent trends

Unfortunately, the trend seems consistent across the nation, said Michaela M. Voss, MD, director of the the Eating Disorders Center at Children’s Mercy in Kansas City, Mo. “Our outpatient setting went from availability to get in immediately to a 6-month wait list.”

As in Michigan, Dr. Voss noted a drop in admissions as lockdowns started, followed by a spike in treatment demand that has not let up.

Dr. Voss described two of the more common presentations. In one, parents might note that their child had been getting into healthy eating and exercise before the pandemic and seemed fine. “But then COVID came, the lockdown happened, and they became overly obsessed with those things,” Dr. Voss said.

In the other presentation, kids with anxiety, depression, or OCD who lost access to their usual coping strategies and outlets developed eating disorders during the pandemic. “They focused on one of the few things they could during the lockdown, which was their own body, and then their anxiety, depression, [obsessive-compulsive disorder], and other mental health comorbidities presented as an eating disorder,” Dr. Voss said.

The increasing need for treatment over the course of the pandemic may reflect the time that it has taken for the disorders to develop, as well as the time that it takes parents to recognize the problem.

Not only are doctors seeing more cases, but patients are arriving sicker than usual, Dr. Voss said.

Major medical concerns for patients in starvation mode center on the heart, brain, and bones. In addition, refeeding syndrome poses an extreme risk, Dr. Voss noted.

The Academy for Eating Disorders has created a guide to help doctors recognize and manage risks for patients with eating disorders, which may be useful for primary care providers while they are trying to get a patient into more intensive treatment, Dr. Voss suggested. The American Academy of Pediatrics recently published a clinical report on the identification and management of eating disorders in children and adolescents.

Dr. Jennifer Leah Goetz

At Johns Hopkins Hospital Children’s Center in Baltimore, “we have seen a pretty remarkable increase in the number of eating disorders in the child and adolescent space since COVID,” said Jennifer Leah Goetz, MD, a psychiatrist and medical director of the child and adolescent inpatient unit. “We have seen increasing numbers of kids presenting for acute medical stabilization and refeeding and for specific treatment for the eating disorder.”

It could be that, for people with a genetic predisposition to eating disorders, a confluence of factors related to the pandemic unmasked it. For example, children may have spent more time looking at themselves on virtual meeting platforms, which could stir lingering body image and appearance-related concerns in those who are vulnerable. And some teens who were not able to participate in athletics as usual started to watch what they eat more closely, Dr. Goetz said.
 

 

 

A treatment bottleneck

Patients with eating disorders “can be quite ill from a psychiatric and general medical perspective,” Dr. Goetz said. “Most psychiatrists are not particularly comfortable with the medical complications, and most internists or pediatricians are not particularly comfortable with the psychiatric complications. You end up with a patient population that can only see a really highly specialized group of individuals for care. And it is a problem. It was a problem before the pandemic, and it has been really exacerbated by what we have been going through with COVID.”

Dr. Natalie Muth

Natalie Muth, MD, MPH, RDN, a pediatrician at Children’s Primary Care Medical Group La Costa in Carlsbad, Calif., has also noticed the increase in eating disorders since COVID.

In-patient colleagues “have longer wait lists and more severe cases than they have ever seen previously,” said Dr. Muth, who chairs the American Academy of Pediatrics Section on Obesity and is an adjunct assistant professor at the University of California, Los Angeles. “In primary care, we are all having to better educate and prepare ourselves for identifying and managing patients with eating disorders.”

That could mean connecting with mental health professionals, registered dietitians, and higher levels of care. But that may be a challenge. “Accessing these resources has been more difficult due to the increasing incidence of eating disorders recently,” Dr. Muth said.

Dr. Voss acknowledged that childhood obesity is another concern for pediatricians. “However, there are appropriate and healthy and safe ways to address that,” she said. A patient with overweight or obesity who loses weight may not be doing so in a healthy way.

Clinicians should wonder if a patient’s weight is decreasing too fast. And they should ask patients questions that could help identify a problem, such as: What are they doing to cause the weight loss? Why do they want to lose the weight?

Dr. Voss added that eating disorders “do not discriminate.” While there may be a perception that all patients with eating disorders are White, upper middle–class females who are thin, “that is not the case,” Dr. Voss said. They “come in all genders, all races, all weight classes, and all ages,” she said, “and we see that variety.”

In general, there may be a need to shift how weight is discussed in clinics and society more broadly, Dr. Goetz said. Weight is an incredibly personal thing, and everyone’s genetics, metabolism, and life circumstances vary. At the same time, body mass index is not necessarily the best measure of a person’s health.

Asking a child, teen, or even an adult to go on a diet is not a benign intervention, Dr. Goetz noted. In addition, dieting is unlikely to help in the long term.

Emerging from lockdown, pressure to lose “COVID pounds” is a dangerous message for people with eating disorders, Dr. Goetz said. It also could be a dangerous message for people without eating disorders. “There are so many more interesting things about each one of us than our weight,” she added.

The study authors, Dr. Voss, Dr. Goetz, and Dr. Muth had no relevant disclosures.

 

Medical admissions for adolescents with restrictive eating disorders more than doubled at one hospital during the first 12 months of the COVID-19 pandemic, relative to the average number of admissions in prior years, a new study shows.

Doctors are seeing similar increases across the United States and in other countries.

Providers and health care systems “may need to rapidly adapt in response to increasing demands for care during the COVID-19 pandemic,” the researchers said in their study, which was published online in Pediatrics.

To assess whether admission patterns among adolescents with restrictive eating disorders changed during the pandemic, Alana K. Otto, MD, MPH, with the division of adolescent medicine at the University of Michigan, Ann Arbor, and colleagues reviewed the charts of patients admitted to C.S. Mott Children’s Hospital, also in Ann Arbor.

Their analysis included 297 admissions among 248 patients aged 10-23 years between March 1, 2017, and March 31, 2021. Patients had an average age of about 15 years. Approximately 90% were female, and most had a diagnosis of anorexia nervosa or atypical anorexia nervosa.

Indications for medical admission included physiological instability (for example, heart rate less than 50 beats per minute while awake or blood pressure less than 90/40 mm Hg), electrolyte derangements, and acute medical complications of malnutrition such as syncope. Other possible indications included uncontrolled purging, body mass index less than 75% of the median for age and sex, acute food refusal, and failure of outpatient treatment.

Eating disorder–related admissions per month were stable prior to the pandemic. Admissions then decreased in April 2020, but subsequently increased significantly throughout the study period. In all, there were 125 admissions between April 1, 2020, and March 31, 2021. During the previous 3 years, the average number of admissions per year was 56.

Patients’ insurance status was one factor that differed before and during the pandemic. Prepandemic, about 20% of admissions were for adolescents with public insurance. During the pandemic, however, the proportion with public insurance was approximately 9%, the researchers noted. Other characteristics were generally similar.

The study was retrospective and relatively small and only looked at patients with restrictive eating disorders who were severely ill and admitted for medical stabilization. It does not reflect adolescents with eating disorders in different settings, the authors noted.

Primary care pediatricians should be familiar with indications for medical admission, such as severe bradycardia, as outlined by the Society for Adolescent Health and Medicine, they said.
 

Consistent trends

Unfortunately, the trend seems consistent across the nation, said Michaela M. Voss, MD, director of the the Eating Disorders Center at Children’s Mercy in Kansas City, Mo. “Our outpatient setting went from availability to get in immediately to a 6-month wait list.”

As in Michigan, Dr. Voss noted a drop in admissions as lockdowns started, followed by a spike in treatment demand that has not let up.

Dr. Voss described two of the more common presentations. In one, parents might note that their child had been getting into healthy eating and exercise before the pandemic and seemed fine. “But then COVID came, the lockdown happened, and they became overly obsessed with those things,” Dr. Voss said.

In the other presentation, kids with anxiety, depression, or OCD who lost access to their usual coping strategies and outlets developed eating disorders during the pandemic. “They focused on one of the few things they could during the lockdown, which was their own body, and then their anxiety, depression, [obsessive-compulsive disorder], and other mental health comorbidities presented as an eating disorder,” Dr. Voss said.

The increasing need for treatment over the course of the pandemic may reflect the time that it has taken for the disorders to develop, as well as the time that it takes parents to recognize the problem.

Not only are doctors seeing more cases, but patients are arriving sicker than usual, Dr. Voss said.

Major medical concerns for patients in starvation mode center on the heart, brain, and bones. In addition, refeeding syndrome poses an extreme risk, Dr. Voss noted.

The Academy for Eating Disorders has created a guide to help doctors recognize and manage risks for patients with eating disorders, which may be useful for primary care providers while they are trying to get a patient into more intensive treatment, Dr. Voss suggested. The American Academy of Pediatrics recently published a clinical report on the identification and management of eating disorders in children and adolescents.

Dr. Jennifer Leah Goetz

At Johns Hopkins Hospital Children’s Center in Baltimore, “we have seen a pretty remarkable increase in the number of eating disorders in the child and adolescent space since COVID,” said Jennifer Leah Goetz, MD, a psychiatrist and medical director of the child and adolescent inpatient unit. “We have seen increasing numbers of kids presenting for acute medical stabilization and refeeding and for specific treatment for the eating disorder.”

It could be that, for people with a genetic predisposition to eating disorders, a confluence of factors related to the pandemic unmasked it. For example, children may have spent more time looking at themselves on virtual meeting platforms, which could stir lingering body image and appearance-related concerns in those who are vulnerable. And some teens who were not able to participate in athletics as usual started to watch what they eat more closely, Dr. Goetz said.
 

 

 

A treatment bottleneck

Patients with eating disorders “can be quite ill from a psychiatric and general medical perspective,” Dr. Goetz said. “Most psychiatrists are not particularly comfortable with the medical complications, and most internists or pediatricians are not particularly comfortable with the psychiatric complications. You end up with a patient population that can only see a really highly specialized group of individuals for care. And it is a problem. It was a problem before the pandemic, and it has been really exacerbated by what we have been going through with COVID.”

Dr. Natalie Muth

Natalie Muth, MD, MPH, RDN, a pediatrician at Children’s Primary Care Medical Group La Costa in Carlsbad, Calif., has also noticed the increase in eating disorders since COVID.

In-patient colleagues “have longer wait lists and more severe cases than they have ever seen previously,” said Dr. Muth, who chairs the American Academy of Pediatrics Section on Obesity and is an adjunct assistant professor at the University of California, Los Angeles. “In primary care, we are all having to better educate and prepare ourselves for identifying and managing patients with eating disorders.”

That could mean connecting with mental health professionals, registered dietitians, and higher levels of care. But that may be a challenge. “Accessing these resources has been more difficult due to the increasing incidence of eating disorders recently,” Dr. Muth said.

Dr. Voss acknowledged that childhood obesity is another concern for pediatricians. “However, there are appropriate and healthy and safe ways to address that,” she said. A patient with overweight or obesity who loses weight may not be doing so in a healthy way.

Clinicians should wonder if a patient’s weight is decreasing too fast. And they should ask patients questions that could help identify a problem, such as: What are they doing to cause the weight loss? Why do they want to lose the weight?

Dr. Voss added that eating disorders “do not discriminate.” While there may be a perception that all patients with eating disorders are White, upper middle–class females who are thin, “that is not the case,” Dr. Voss said. They “come in all genders, all races, all weight classes, and all ages,” she said, “and we see that variety.”

In general, there may be a need to shift how weight is discussed in clinics and society more broadly, Dr. Goetz said. Weight is an incredibly personal thing, and everyone’s genetics, metabolism, and life circumstances vary. At the same time, body mass index is not necessarily the best measure of a person’s health.

Asking a child, teen, or even an adult to go on a diet is not a benign intervention, Dr. Goetz noted. In addition, dieting is unlikely to help in the long term.

Emerging from lockdown, pressure to lose “COVID pounds” is a dangerous message for people with eating disorders, Dr. Goetz said. It also could be a dangerous message for people without eating disorders. “There are so many more interesting things about each one of us than our weight,” she added.

The study authors, Dr. Voss, Dr. Goetz, and Dr. Muth had no relevant disclosures.

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Tennessee fires top vaccine official as COVID cases increase

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Thu, 08/26/2021 - 15:44

 

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

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Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

 

Tennessee officials have fired the state’s top vaccination manager, who faced recent criticism from Republican lawmakers about her efforts to vaccinate teens against COVID-19.

Michelle Fiscus, MD, the medical director for vaccine-preventable diseases and immunization programs at the Tennessee Department of Health, was terminated on July 12. The termination letter doesn’t explain the reason for her dismissal, according to the newspaper, which received a copy of the letter.

“It was my job to provide evidence-based education and vaccine access so that Tennesseans could protect themselves against COVID-19,” Dr. Fiscus told the Tennessean. “I have now been terminated for doing exactly that.”

In May, Dr. Fiscus sent a memo to medical providers that described the state’s “Mature Minor Doctrine,” a legal mechanism established in 1987 that allows some minors between the ages if 14 and 17 years to receive medical care without parental consent. Tennessee is one of five states that allows health care providers to decide if a minor has the capacity to consent to care, according to CNN.

Dr. Fiscus said she sent the letter in response to providers’ questions and that it contained no new information. She also said the wording was approved by the health department’s attorney and the governor’s office, the newspaper reported.

At a June 16 hearing of the state’s Joint Government Operations Committee, however, Republican officials criticized the memo and Dr. Fiscus, saying that the state misinterpreted its legal authority. During the meeting, some lawmakers discussed dissolving the state health department to stop it from promoting vaccines to teens, the newspaper reported.

Since then, the health department has backed down from promoting vaccines to teens by deleting social media posts that recommended vaccines to anyone over age 12. Internal emails, which were obtained by the Tennessean, showed that department leaders ordered county-level employees to avoid holding vaccine events targeted toward adolescents.

Dr. Fiscus’s firing comes as vaccination efforts lag in the state. About 38% of residents have been fully vaccinated. At the current pace, Tennessee won’t pass the 50% mark until next March, according to an internal report obtained by the newspaper.

COVID-19 cases are beginning to climb again, particularly with the Delta variant circulating among unvaccinated residents. After months of a decline in cases, the average of daily cases has more than doubled since the end of June. The state’s test positivity rate has increased from 2% to 4.5% during that time as well.

In a long written statement, Dr. Fiscus said she was the 25th of 64 state and territorial immunization program directors to leave their positions during the pandemic, whether through resignation or termination. With a loss of institutional knowledge and leadership, COVID-19 vaccine efforts will fall behind.

“Each of us should be waking up every morning with one question on our minds: ‘What can I do protect the people of Tennessee against COVID-19?’ ” she wrote. “Instead, our leaders are putting barriers in place to ensure the people of Tennessee remain at risk, even with the Delta variant bearing down upon us.”

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

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Talking about guns: Website helps physicians follow through on pledge

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Thu, 07/15/2021 - 14:46

 

In the 3 years since more than 1,000 physicians signed a pledge to talk with patients about the guns in their homes, a team of clinicians and data analysts at the University of California, Davis (UC Davis) has been helping them make good on their promises.

The group has developed a national resource for clinicians who wish to address the problem of gun violence deaths in the United States, which continue to mount by the day.

Signatures came quickly in 2018 after the Annals of Internal Medicine asked physicians to sign a formal pledge in which they commit to talking with their patients about firearms. To date, the list has grown to more than 3,600, and it remains open for additional signatories.

The effort built on data showing that before people commit violence with firearms, they often have notable risk factors that prompt them to see a physician.

At the time the pledge campaign was launched, frustration and despair had hit new highs after the school shooting of Feb. 14, 2018, in Parkland, Florida, in which 17 people were killed. That occurred just 4 months after the mass shooting in Las Vegas, Nevada, on Oct. 1, 2017, in which 58 people were gunned down.

An editorial by Garen J. Wintemute, MD, MPH, helped kick off the drive.
 

More deaths than WWII combat fatalities

Dr. Wintemute cited some grim statistics, writing that “nationwide in 2016, there was an average of 97 deaths from firearm violence per day: 35,476 altogether. In the 10 years ending with 2016, deaths of U.S. civilians from firearm violence exceeded American combat fatalities in World War II.”

Amy Barnhorst, MD, vice chair of psychiatry at UC Davis, who was one of the early signers of the pledge, told this news organization that data analyst Rocco Pallin, MPH, with the UC Davis Violence Prevention Research Program (VPRP), quickly started managing commitments to the pledge and developed a “What You Can Do” intervention for physicians looking for help on how to prevent firearm injury and death.

Those efforts snowballed, and a need arose for a centralized public resource. In 2019, the state of California gave $3.8 million to the VPRP, which helped launch the BulletPoints Project, which Dr. Barnhorst now directs.

The website provides clinicians with evidence-based direction on how to have the conversations with patients. It walks them through various scenarios and details what can be done if what they learn during a patient interview requires action.

Dr. Barnhorst said the team is working on formalized online educational courses for mental health professionals and medical clinicians that will be hosted through various national organizations.

Christine Laine, MD, editor-in-chief of the Annals of Internal Medicine, said in an interview that although almost 4,000 persons have made the pledge, that number should be higher. She notes that the American College of Physicians has about 165,000 members, and even that is only a fraction of all physicians and clinicians.

“Signing the pledge helps raise awareness that this is a public health issue and, within the realm of health care providers, that they should be counseling patients about reducing risk, the same way we counsel people to wear bike helmets and use seat belts,” she said.

Dr. Barnhorst says those who don’t want to sign the pledge usually cite time considerations and that they already talk with patients about a list of public health issues. They also say they don’t know how to have the conversations or what they should do if what they hear in the interviews requires action.

“We can’t do anything about the time, but we can do something about the resources,” Dr. Barnhorst said.

Some clinicians, she said, worry that patients will get angry if physicians ask about guns, or they believe it’s illegal to ask.

“But there’s no law preventing physicians from asking these questions,” she said.

Dr. Wintemute told this news organization that he is not discouraged that only about 4,000 have signed the pledge. Rather, he was encouraged that the signatures came so quickly. He also notes that the number of persons who are interested far exceeds the number who have made the pledge.

Boosting the pledge numbers will likely take a new push in the form of published articles, he added, and those are in the works.

Among the next steps is conducting pre- and post-tests to see whether BulletPoints is effectively conveying the information for users, he said.

Another is pushing for advances in petitioning for “extreme risk protection orders,” which would require a gun owner to temporarily relinquish any firearms and ammunition and not purchase additional firearms.

Dr. Wintemute said that currently, Maryland is the only state in which health care professionals can petition for extreme risk protection orders. In any state that has the law, a health care professional can contact law enforcement about “a person who is at very high risk for violence in the very near future” but who has not committed a crime and is not mentally ill and so cannot be legally detained.

For physicians to include gun counseling as a routine part of patient care will likely require hearing from peers who are finding the time to do this effectively and hearing that it matters, he said.

“It’s going to take that on-the-ground diffusion of information, just as it has with vaccine hesitancy,” he said.

He notes that data on how to stop firearm violence are sparse and approaches so far have extrapolated from information on how to stop other health threats, such as smoking and drinking.

But that is changing rapidly, he said: “There’s funding from the CDC for research into the kind of work we’re doing.”

Measuring the success of those efforts is difficult.

One sign of change in the past 3 years, Dr. Wintemute says, is that there’s recognition among health care professionals and the public that this fits into clinicians’ “lane.”
 

 

 

Mass shootings not the largest source of gun violence

Mass shootings continue to dominate news about fatal shootings, but Dr. Barnhorst notes that such shootings represent a very small part – reportedly 1% to 2% – of the firearm deaths in the United States. Almost two-thirds of the deaths are suicides. Domestic violence deaths make up another large sector.

But it’s the mass shootings that stick in the collective U.S. consciousness, and the rising and unrelenting numbers can lead to a sense of futility.

Dr. Barnhorst, Dr. Laine, and Dr. Wintemute acknowledge they don’t know to what degree physicians’ talking to patients about firearms can help. But they do not doubt it’s worthy of the effort.

Dr. Laine said that during the past year, COVID-19 overshadowed the focus on the pledge, but he notes the signup for the pledge remains open. Information on firearm injury is collected on the Annals website.

Dr. Barnhorst says there is no good answer to the question of how many lives need to be saved before talking with patients about firearms becomes worth the effort. “For me,” she said, “that number is very, very low.”

Dr. Laine puts the number at one.

“If a physician talking to their patients about firearms prevents one suicide, then the intervention is a success,” she said.

Dr. Laine, Dr. Barnhorst, and Dr. Wintemute report no relevant financial relationships.

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

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In the 3 years since more than 1,000 physicians signed a pledge to talk with patients about the guns in their homes, a team of clinicians and data analysts at the University of California, Davis (UC Davis) has been helping them make good on their promises.

The group has developed a national resource for clinicians who wish to address the problem of gun violence deaths in the United States, which continue to mount by the day.

Signatures came quickly in 2018 after the Annals of Internal Medicine asked physicians to sign a formal pledge in which they commit to talking with their patients about firearms. To date, the list has grown to more than 3,600, and it remains open for additional signatories.

The effort built on data showing that before people commit violence with firearms, they often have notable risk factors that prompt them to see a physician.

At the time the pledge campaign was launched, frustration and despair had hit new highs after the school shooting of Feb. 14, 2018, in Parkland, Florida, in which 17 people were killed. That occurred just 4 months after the mass shooting in Las Vegas, Nevada, on Oct. 1, 2017, in which 58 people were gunned down.

An editorial by Garen J. Wintemute, MD, MPH, helped kick off the drive.
 

More deaths than WWII combat fatalities

Dr. Wintemute cited some grim statistics, writing that “nationwide in 2016, there was an average of 97 deaths from firearm violence per day: 35,476 altogether. In the 10 years ending with 2016, deaths of U.S. civilians from firearm violence exceeded American combat fatalities in World War II.”

Amy Barnhorst, MD, vice chair of psychiatry at UC Davis, who was one of the early signers of the pledge, told this news organization that data analyst Rocco Pallin, MPH, with the UC Davis Violence Prevention Research Program (VPRP), quickly started managing commitments to the pledge and developed a “What You Can Do” intervention for physicians looking for help on how to prevent firearm injury and death.

Those efforts snowballed, and a need arose for a centralized public resource. In 2019, the state of California gave $3.8 million to the VPRP, which helped launch the BulletPoints Project, which Dr. Barnhorst now directs.

The website provides clinicians with evidence-based direction on how to have the conversations with patients. It walks them through various scenarios and details what can be done if what they learn during a patient interview requires action.

Dr. Barnhorst said the team is working on formalized online educational courses for mental health professionals and medical clinicians that will be hosted through various national organizations.

Christine Laine, MD, editor-in-chief of the Annals of Internal Medicine, said in an interview that although almost 4,000 persons have made the pledge, that number should be higher. She notes that the American College of Physicians has about 165,000 members, and even that is only a fraction of all physicians and clinicians.

“Signing the pledge helps raise awareness that this is a public health issue and, within the realm of health care providers, that they should be counseling patients about reducing risk, the same way we counsel people to wear bike helmets and use seat belts,” she said.

Dr. Barnhorst says those who don’t want to sign the pledge usually cite time considerations and that they already talk with patients about a list of public health issues. They also say they don’t know how to have the conversations or what they should do if what they hear in the interviews requires action.

“We can’t do anything about the time, but we can do something about the resources,” Dr. Barnhorst said.

Some clinicians, she said, worry that patients will get angry if physicians ask about guns, or they believe it’s illegal to ask.

“But there’s no law preventing physicians from asking these questions,” she said.

Dr. Wintemute told this news organization that he is not discouraged that only about 4,000 have signed the pledge. Rather, he was encouraged that the signatures came so quickly. He also notes that the number of persons who are interested far exceeds the number who have made the pledge.

Boosting the pledge numbers will likely take a new push in the form of published articles, he added, and those are in the works.

Among the next steps is conducting pre- and post-tests to see whether BulletPoints is effectively conveying the information for users, he said.

Another is pushing for advances in petitioning for “extreme risk protection orders,” which would require a gun owner to temporarily relinquish any firearms and ammunition and not purchase additional firearms.

Dr. Wintemute said that currently, Maryland is the only state in which health care professionals can petition for extreme risk protection orders. In any state that has the law, a health care professional can contact law enforcement about “a person who is at very high risk for violence in the very near future” but who has not committed a crime and is not mentally ill and so cannot be legally detained.

For physicians to include gun counseling as a routine part of patient care will likely require hearing from peers who are finding the time to do this effectively and hearing that it matters, he said.

“It’s going to take that on-the-ground diffusion of information, just as it has with vaccine hesitancy,” he said.

He notes that data on how to stop firearm violence are sparse and approaches so far have extrapolated from information on how to stop other health threats, such as smoking and drinking.

But that is changing rapidly, he said: “There’s funding from the CDC for research into the kind of work we’re doing.”

Measuring the success of those efforts is difficult.

One sign of change in the past 3 years, Dr. Wintemute says, is that there’s recognition among health care professionals and the public that this fits into clinicians’ “lane.”
 

 

 

Mass shootings not the largest source of gun violence

Mass shootings continue to dominate news about fatal shootings, but Dr. Barnhorst notes that such shootings represent a very small part – reportedly 1% to 2% – of the firearm deaths in the United States. Almost two-thirds of the deaths are suicides. Domestic violence deaths make up another large sector.

But it’s the mass shootings that stick in the collective U.S. consciousness, and the rising and unrelenting numbers can lead to a sense of futility.

Dr. Barnhorst, Dr. Laine, and Dr. Wintemute acknowledge they don’t know to what degree physicians’ talking to patients about firearms can help. But they do not doubt it’s worthy of the effort.

Dr. Laine said that during the past year, COVID-19 overshadowed the focus on the pledge, but he notes the signup for the pledge remains open. Information on firearm injury is collected on the Annals website.

Dr. Barnhorst says there is no good answer to the question of how many lives need to be saved before talking with patients about firearms becomes worth the effort. “For me,” she said, “that number is very, very low.”

Dr. Laine puts the number at one.

“If a physician talking to their patients about firearms prevents one suicide, then the intervention is a success,” she said.

Dr. Laine, Dr. Barnhorst, and Dr. Wintemute report no relevant financial relationships.

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

 

In the 3 years since more than 1,000 physicians signed a pledge to talk with patients about the guns in their homes, a team of clinicians and data analysts at the University of California, Davis (UC Davis) has been helping them make good on their promises.

The group has developed a national resource for clinicians who wish to address the problem of gun violence deaths in the United States, which continue to mount by the day.

Signatures came quickly in 2018 after the Annals of Internal Medicine asked physicians to sign a formal pledge in which they commit to talking with their patients about firearms. To date, the list has grown to more than 3,600, and it remains open for additional signatories.

The effort built on data showing that before people commit violence with firearms, they often have notable risk factors that prompt them to see a physician.

At the time the pledge campaign was launched, frustration and despair had hit new highs after the school shooting of Feb. 14, 2018, in Parkland, Florida, in which 17 people were killed. That occurred just 4 months after the mass shooting in Las Vegas, Nevada, on Oct. 1, 2017, in which 58 people were gunned down.

An editorial by Garen J. Wintemute, MD, MPH, helped kick off the drive.
 

More deaths than WWII combat fatalities

Dr. Wintemute cited some grim statistics, writing that “nationwide in 2016, there was an average of 97 deaths from firearm violence per day: 35,476 altogether. In the 10 years ending with 2016, deaths of U.S. civilians from firearm violence exceeded American combat fatalities in World War II.”

Amy Barnhorst, MD, vice chair of psychiatry at UC Davis, who was one of the early signers of the pledge, told this news organization that data analyst Rocco Pallin, MPH, with the UC Davis Violence Prevention Research Program (VPRP), quickly started managing commitments to the pledge and developed a “What You Can Do” intervention for physicians looking for help on how to prevent firearm injury and death.

Those efforts snowballed, and a need arose for a centralized public resource. In 2019, the state of California gave $3.8 million to the VPRP, which helped launch the BulletPoints Project, which Dr. Barnhorst now directs.

The website provides clinicians with evidence-based direction on how to have the conversations with patients. It walks them through various scenarios and details what can be done if what they learn during a patient interview requires action.

Dr. Barnhorst said the team is working on formalized online educational courses for mental health professionals and medical clinicians that will be hosted through various national organizations.

Christine Laine, MD, editor-in-chief of the Annals of Internal Medicine, said in an interview that although almost 4,000 persons have made the pledge, that number should be higher. She notes that the American College of Physicians has about 165,000 members, and even that is only a fraction of all physicians and clinicians.

“Signing the pledge helps raise awareness that this is a public health issue and, within the realm of health care providers, that they should be counseling patients about reducing risk, the same way we counsel people to wear bike helmets and use seat belts,” she said.

Dr. Barnhorst says those who don’t want to sign the pledge usually cite time considerations and that they already talk with patients about a list of public health issues. They also say they don’t know how to have the conversations or what they should do if what they hear in the interviews requires action.

“We can’t do anything about the time, but we can do something about the resources,” Dr. Barnhorst said.

Some clinicians, she said, worry that patients will get angry if physicians ask about guns, or they believe it’s illegal to ask.

“But there’s no law preventing physicians from asking these questions,” she said.

Dr. Wintemute told this news organization that he is not discouraged that only about 4,000 have signed the pledge. Rather, he was encouraged that the signatures came so quickly. He also notes that the number of persons who are interested far exceeds the number who have made the pledge.

Boosting the pledge numbers will likely take a new push in the form of published articles, he added, and those are in the works.

Among the next steps is conducting pre- and post-tests to see whether BulletPoints is effectively conveying the information for users, he said.

Another is pushing for advances in petitioning for “extreme risk protection orders,” which would require a gun owner to temporarily relinquish any firearms and ammunition and not purchase additional firearms.

Dr. Wintemute said that currently, Maryland is the only state in which health care professionals can petition for extreme risk protection orders. In any state that has the law, a health care professional can contact law enforcement about “a person who is at very high risk for violence in the very near future” but who has not committed a crime and is not mentally ill and so cannot be legally detained.

For physicians to include gun counseling as a routine part of patient care will likely require hearing from peers who are finding the time to do this effectively and hearing that it matters, he said.

“It’s going to take that on-the-ground diffusion of information, just as it has with vaccine hesitancy,” he said.

He notes that data on how to stop firearm violence are sparse and approaches so far have extrapolated from information on how to stop other health threats, such as smoking and drinking.

But that is changing rapidly, he said: “There’s funding from the CDC for research into the kind of work we’re doing.”

Measuring the success of those efforts is difficult.

One sign of change in the past 3 years, Dr. Wintemute says, is that there’s recognition among health care professionals and the public that this fits into clinicians’ “lane.”
 

 

 

Mass shootings not the largest source of gun violence

Mass shootings continue to dominate news about fatal shootings, but Dr. Barnhorst notes that such shootings represent a very small part – reportedly 1% to 2% – of the firearm deaths in the United States. Almost two-thirds of the deaths are suicides. Domestic violence deaths make up another large sector.

But it’s the mass shootings that stick in the collective U.S. consciousness, and the rising and unrelenting numbers can lead to a sense of futility.

Dr. Barnhorst, Dr. Laine, and Dr. Wintemute acknowledge they don’t know to what degree physicians’ talking to patients about firearms can help. But they do not doubt it’s worthy of the effort.

Dr. Laine said that during the past year, COVID-19 overshadowed the focus on the pledge, but he notes the signup for the pledge remains open. Information on firearm injury is collected on the Annals website.

Dr. Barnhorst says there is no good answer to the question of how many lives need to be saved before talking with patients about firearms becomes worth the effort. “For me,” she said, “that number is very, very low.”

Dr. Laine puts the number at one.

“If a physician talking to their patients about firearms prevents one suicide, then the intervention is a success,” she said.

Dr. Laine, Dr. Barnhorst, and Dr. Wintemute report no relevant financial relationships.

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

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Trans youth in sports

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Wed, 07/14/2021 - 14:39

Over the last several years, the United States has seen a substantial increase in proposed legislation directed toward transgender individuals, particularly youth.1 One type of this legislation aims to prevent participation of transgender girls on female sports teams. While at first glance these bills may seem like common sense protections, in reality they are based on little evidence and serve to further marginalize an already-vulnerable population.

Dr. Shauna M. Lawlis

The majority of the population, and thus the majority of athletes, are cisgender.2 According a limited data set from the 2017 Youth Risk Behavior Survey, only 1.8% of high school students identify as transgender.3,4 Overall, this is a very small percentage and it is unlikely that all of them, or even a majority, participate in athletics. In fact, many transgender individuals avoid athletics as it worsens their dysphoria. Winners are no more likely to be transgender than cisgender.

While proponents of this legislation say that trans women have an unfair advantage because of elevated testosterone levels (and thus theoretically increased muscle mass), there is no clear relationship between higher testosterone levels in athletes and improved athletic performance.2 In fact, there are plenty of sports in which a smaller physique may be beneficial, such as gymnastics. A systematic review showed “no direct or consistent research suggesting transgender female individuals ... have an athletic advantage at any stage of their transition.”5 Furthermore, trans women are not the only women with elevated testosterone levels. Many cisgender women who have polycystic ovary syndrome or a disorder of sexual differentiation can have higher levels of testosterone and theoretically may have higher muscle mass. Who is to decide which team would be most appropriate for them? Is the plan to require a karyotype, other genetic testing, or an invasive physical exam for every young athlete? Even if the concern is with regards to testosterone levels and muscle mass, this ignores that fact that appropriate medical intervention for transgender adolescents will alter these attributes. If a transgender girl began gonadotropin-releasing hormone agonists early in puberty, she is unlikely to have increased muscle mass or a higher testosterone level than a cisgender girl. Those trans girls who take estradiol also experience a decrease in muscle mass. Additionally, adolescents grow and develop at different rates – surely there is already significant variability among hormone levels, muscle mass, sexual maturity ratings, and ability among individual athletes, regardless of gender identity? The argument that trans women should be excluded based on a theoretical genetic advantage is reminiscent of the argument that Black athletes should be excluded because of genetic advantage. Just as with cisgender athletes, transgender athletes will naturally vary in ability.6

In addition, there are many places and organizations that already have trans-inclusive policies in place for sports, yet we have not seen transgender individuals dominate their peers. In the 8 years since implementation of a trans-inclusive sports policy in California, a trans woman has never dominated a sport.7 The same is true for Canada since the institution of their policy 2 years ago. While transgender people can participate in the Olympics, this year marks the first time a trans woman has ever qualified (Laurel Hubbard, New Zealand, women’s weightlifting). The lack of transgender Olympians may be in part because of problematic requirements (such as duration of hormone therapy and surgery requirements) for transgender individuals, which may be so onerous that they are functionally excluded.2,5

In reality, athletes are improving over time and the performance gap between genders is shrinking. For example, in 1970 Mark Spitz swam the 100-meter freestyle in 51.94 seconds, a time that has now been surpassed by both men and women, such as Sarah Sjöström (women’s world record holder at 51.71 seconds). Athletes’ physical attributes are often less important than their training and dedication to their sport.

More importantly, this discussion raises the philosophical question of the purpose of athletics for youth and young adults. Winning and good performance can – though rarely – lead to college scholarships and professional careers, the biggest benefit of athletics comes from participation. We encourage youth to play sports not to win, but to learn about leadership, dedication, and collegiality, as well as for the health benefits of exercise. Inclusion in sports and other extracurricular activities improves depression, anxiety, and suicide rates. In fact, participation in sports has been associated with improved grades, greater homework completion, higher educational and occupational aspirations, and improved self-esteem.8-12 Excluding a population that already experiences such drastic marginalization will cause more damage. Values of nondiscrimination and inclusion should be promoted among all student athletes, rather than “other-ism.”

Forcing trans women to compete with men will worsen their dysphoria and further ostracize the most vulnerable, giving credence to those that believe they are not “real women.” Allowing transgender individuals to play on the team consistent with their gender identity is appropriate, not only for scientific reasons but also for humanitarian ones. Such laws are based not on evidence, but on discrimination. Not only do trans women not do better than cisgender women in sports, but such proposed legislation also ignores the normal variability among individuals as well as the intense training and dedication involved in becoming a top athlete. Limiting trans women’s participation in sports does not raise up cisgender women, but rather brings us all down. Please advocate for your patients to participate in athletics in accordance with their gender identity to promote both their physical and emotional well-being.

Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures.

References

1. Cooper MB. Pediatric News. 2020 Dec 11, 2020.

2. Turban J. Scientific American. 2021 May 21.

3. Redfield RR et al. Morbid Mortal Wkly Rep. 2018;67(8):1-11.

4. Johns MM et al. Morbid Mortal Wkly Rep. 2019;68(3):67-71.

5. Jones BA et al. Sports Med (Auckland, New Zealand). 2017;47(4):701-16.

6. Strangio C et al. ACLU News. 2020 Apr 30.

7. Strauss L. USA Today. 2021 Apr 9.

8. Darling N et al. J Leisure Res. 2005;37(1):51-76.

9. Fredricks JA et al. Dev Psych. 2006;42(4):698-713.

10. Marsh HW et al. J Sport Exerc Psychol. 2003;25(2):205.

11. Nelson MC et al. Pediatrics. 2006;117(4):1281-90.

12. Ortega FB et al. Int J Obes. 2008;32(1):1-11.

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Over the last several years, the United States has seen a substantial increase in proposed legislation directed toward transgender individuals, particularly youth.1 One type of this legislation aims to prevent participation of transgender girls on female sports teams. While at first glance these bills may seem like common sense protections, in reality they are based on little evidence and serve to further marginalize an already-vulnerable population.

Dr. Shauna M. Lawlis

The majority of the population, and thus the majority of athletes, are cisgender.2 According a limited data set from the 2017 Youth Risk Behavior Survey, only 1.8% of high school students identify as transgender.3,4 Overall, this is a very small percentage and it is unlikely that all of them, or even a majority, participate in athletics. In fact, many transgender individuals avoid athletics as it worsens their dysphoria. Winners are no more likely to be transgender than cisgender.

While proponents of this legislation say that trans women have an unfair advantage because of elevated testosterone levels (and thus theoretically increased muscle mass), there is no clear relationship between higher testosterone levels in athletes and improved athletic performance.2 In fact, there are plenty of sports in which a smaller physique may be beneficial, such as gymnastics. A systematic review showed “no direct or consistent research suggesting transgender female individuals ... have an athletic advantage at any stage of their transition.”5 Furthermore, trans women are not the only women with elevated testosterone levels. Many cisgender women who have polycystic ovary syndrome or a disorder of sexual differentiation can have higher levels of testosterone and theoretically may have higher muscle mass. Who is to decide which team would be most appropriate for them? Is the plan to require a karyotype, other genetic testing, or an invasive physical exam for every young athlete? Even if the concern is with regards to testosterone levels and muscle mass, this ignores that fact that appropriate medical intervention for transgender adolescents will alter these attributes. If a transgender girl began gonadotropin-releasing hormone agonists early in puberty, she is unlikely to have increased muscle mass or a higher testosterone level than a cisgender girl. Those trans girls who take estradiol also experience a decrease in muscle mass. Additionally, adolescents grow and develop at different rates – surely there is already significant variability among hormone levels, muscle mass, sexual maturity ratings, and ability among individual athletes, regardless of gender identity? The argument that trans women should be excluded based on a theoretical genetic advantage is reminiscent of the argument that Black athletes should be excluded because of genetic advantage. Just as with cisgender athletes, transgender athletes will naturally vary in ability.6

In addition, there are many places and organizations that already have trans-inclusive policies in place for sports, yet we have not seen transgender individuals dominate their peers. In the 8 years since implementation of a trans-inclusive sports policy in California, a trans woman has never dominated a sport.7 The same is true for Canada since the institution of their policy 2 years ago. While transgender people can participate in the Olympics, this year marks the first time a trans woman has ever qualified (Laurel Hubbard, New Zealand, women’s weightlifting). The lack of transgender Olympians may be in part because of problematic requirements (such as duration of hormone therapy and surgery requirements) for transgender individuals, which may be so onerous that they are functionally excluded.2,5

In reality, athletes are improving over time and the performance gap between genders is shrinking. For example, in 1970 Mark Spitz swam the 100-meter freestyle in 51.94 seconds, a time that has now been surpassed by both men and women, such as Sarah Sjöström (women’s world record holder at 51.71 seconds). Athletes’ physical attributes are often less important than their training and dedication to their sport.

More importantly, this discussion raises the philosophical question of the purpose of athletics for youth and young adults. Winning and good performance can – though rarely – lead to college scholarships and professional careers, the biggest benefit of athletics comes from participation. We encourage youth to play sports not to win, but to learn about leadership, dedication, and collegiality, as well as for the health benefits of exercise. Inclusion in sports and other extracurricular activities improves depression, anxiety, and suicide rates. In fact, participation in sports has been associated with improved grades, greater homework completion, higher educational and occupational aspirations, and improved self-esteem.8-12 Excluding a population that already experiences such drastic marginalization will cause more damage. Values of nondiscrimination and inclusion should be promoted among all student athletes, rather than “other-ism.”

Forcing trans women to compete with men will worsen their dysphoria and further ostracize the most vulnerable, giving credence to those that believe they are not “real women.” Allowing transgender individuals to play on the team consistent with their gender identity is appropriate, not only for scientific reasons but also for humanitarian ones. Such laws are based not on evidence, but on discrimination. Not only do trans women not do better than cisgender women in sports, but such proposed legislation also ignores the normal variability among individuals as well as the intense training and dedication involved in becoming a top athlete. Limiting trans women’s participation in sports does not raise up cisgender women, but rather brings us all down. Please advocate for your patients to participate in athletics in accordance with their gender identity to promote both their physical and emotional well-being.

Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures.

References

1. Cooper MB. Pediatric News. 2020 Dec 11, 2020.

2. Turban J. Scientific American. 2021 May 21.

3. Redfield RR et al. Morbid Mortal Wkly Rep. 2018;67(8):1-11.

4. Johns MM et al. Morbid Mortal Wkly Rep. 2019;68(3):67-71.

5. Jones BA et al. Sports Med (Auckland, New Zealand). 2017;47(4):701-16.

6. Strangio C et al. ACLU News. 2020 Apr 30.

7. Strauss L. USA Today. 2021 Apr 9.

8. Darling N et al. J Leisure Res. 2005;37(1):51-76.

9. Fredricks JA et al. Dev Psych. 2006;42(4):698-713.

10. Marsh HW et al. J Sport Exerc Psychol. 2003;25(2):205.

11. Nelson MC et al. Pediatrics. 2006;117(4):1281-90.

12. Ortega FB et al. Int J Obes. 2008;32(1):1-11.

Over the last several years, the United States has seen a substantial increase in proposed legislation directed toward transgender individuals, particularly youth.1 One type of this legislation aims to prevent participation of transgender girls on female sports teams. While at first glance these bills may seem like common sense protections, in reality they are based on little evidence and serve to further marginalize an already-vulnerable population.

Dr. Shauna M. Lawlis

The majority of the population, and thus the majority of athletes, are cisgender.2 According a limited data set from the 2017 Youth Risk Behavior Survey, only 1.8% of high school students identify as transgender.3,4 Overall, this is a very small percentage and it is unlikely that all of them, or even a majority, participate in athletics. In fact, many transgender individuals avoid athletics as it worsens their dysphoria. Winners are no more likely to be transgender than cisgender.

While proponents of this legislation say that trans women have an unfair advantage because of elevated testosterone levels (and thus theoretically increased muscle mass), there is no clear relationship between higher testosterone levels in athletes and improved athletic performance.2 In fact, there are plenty of sports in which a smaller physique may be beneficial, such as gymnastics. A systematic review showed “no direct or consistent research suggesting transgender female individuals ... have an athletic advantage at any stage of their transition.”5 Furthermore, trans women are not the only women with elevated testosterone levels. Many cisgender women who have polycystic ovary syndrome or a disorder of sexual differentiation can have higher levels of testosterone and theoretically may have higher muscle mass. Who is to decide which team would be most appropriate for them? Is the plan to require a karyotype, other genetic testing, or an invasive physical exam for every young athlete? Even if the concern is with regards to testosterone levels and muscle mass, this ignores that fact that appropriate medical intervention for transgender adolescents will alter these attributes. If a transgender girl began gonadotropin-releasing hormone agonists early in puberty, she is unlikely to have increased muscle mass or a higher testosterone level than a cisgender girl. Those trans girls who take estradiol also experience a decrease in muscle mass. Additionally, adolescents grow and develop at different rates – surely there is already significant variability among hormone levels, muscle mass, sexual maturity ratings, and ability among individual athletes, regardless of gender identity? The argument that trans women should be excluded based on a theoretical genetic advantage is reminiscent of the argument that Black athletes should be excluded because of genetic advantage. Just as with cisgender athletes, transgender athletes will naturally vary in ability.6

In addition, there are many places and organizations that already have trans-inclusive policies in place for sports, yet we have not seen transgender individuals dominate their peers. In the 8 years since implementation of a trans-inclusive sports policy in California, a trans woman has never dominated a sport.7 The same is true for Canada since the institution of their policy 2 years ago. While transgender people can participate in the Olympics, this year marks the first time a trans woman has ever qualified (Laurel Hubbard, New Zealand, women’s weightlifting). The lack of transgender Olympians may be in part because of problematic requirements (such as duration of hormone therapy and surgery requirements) for transgender individuals, which may be so onerous that they are functionally excluded.2,5

In reality, athletes are improving over time and the performance gap between genders is shrinking. For example, in 1970 Mark Spitz swam the 100-meter freestyle in 51.94 seconds, a time that has now been surpassed by both men and women, such as Sarah Sjöström (women’s world record holder at 51.71 seconds). Athletes’ physical attributes are often less important than their training and dedication to their sport.

More importantly, this discussion raises the philosophical question of the purpose of athletics for youth and young adults. Winning and good performance can – though rarely – lead to college scholarships and professional careers, the biggest benefit of athletics comes from participation. We encourage youth to play sports not to win, but to learn about leadership, dedication, and collegiality, as well as for the health benefits of exercise. Inclusion in sports and other extracurricular activities improves depression, anxiety, and suicide rates. In fact, participation in sports has been associated with improved grades, greater homework completion, higher educational and occupational aspirations, and improved self-esteem.8-12 Excluding a population that already experiences such drastic marginalization will cause more damage. Values of nondiscrimination and inclusion should be promoted among all student athletes, rather than “other-ism.”

Forcing trans women to compete with men will worsen their dysphoria and further ostracize the most vulnerable, giving credence to those that believe they are not “real women.” Allowing transgender individuals to play on the team consistent with their gender identity is appropriate, not only for scientific reasons but also for humanitarian ones. Such laws are based not on evidence, but on discrimination. Not only do trans women not do better than cisgender women in sports, but such proposed legislation also ignores the normal variability among individuals as well as the intense training and dedication involved in becoming a top athlete. Limiting trans women’s participation in sports does not raise up cisgender women, but rather brings us all down. Please advocate for your patients to participate in athletics in accordance with their gender identity to promote both their physical and emotional well-being.

Dr. Lawlis is assistant professor of pediatrics at the University of Oklahoma Health Sciences Center, Oklahoma City, and an adolescent medicine specialist at OU Children’s. She has no relevant financial disclosures.

References

1. Cooper MB. Pediatric News. 2020 Dec 11, 2020.

2. Turban J. Scientific American. 2021 May 21.

3. Redfield RR et al. Morbid Mortal Wkly Rep. 2018;67(8):1-11.

4. Johns MM et al. Morbid Mortal Wkly Rep. 2019;68(3):67-71.

5. Jones BA et al. Sports Med (Auckland, New Zealand). 2017;47(4):701-16.

6. Strangio C et al. ACLU News. 2020 Apr 30.

7. Strauss L. USA Today. 2021 Apr 9.

8. Darling N et al. J Leisure Res. 2005;37(1):51-76.

9. Fredricks JA et al. Dev Psych. 2006;42(4):698-713.

10. Marsh HW et al. J Sport Exerc Psychol. 2003;25(2):205.

11. Nelson MC et al. Pediatrics. 2006;117(4):1281-90.

12. Ortega FB et al. Int J Obes. 2008;32(1):1-11.

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State-of-the-art psych unit designed with recovery in mind

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Changed
Thu, 08/26/2021 - 15:44

Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.

The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.

Dr. Sarah Edwards


“We offer a really warm and welcoming environment that we think is going to promote health and healing,” the unit’s head, Sarah Edwards, DO, director of child and adolescent psychiatry at UMMC and assistant professor of psychiatry, University of Maryland School of Medicine (UMSOM), Baltimore, said in an interview.

Previous research shows that 1 in 4 children experience some kind of maltreatment, whether physical, sexual, or emotional, and that 1 in 5 develop a diagnosable mental health disorder.

The pandemic has added to the already stressful circumstances that many youth in Baltimore and elsewhere face, Dr. Edwards noted. Recent data show that the rate of suicidal ideation among youth has increased significantly during the COVID-19 crisis.

“Urban children have unfortunately suffered a lot of what we call traumatic stress, so they might be victims of physical or sexual abuse but also face layers of stressful situations – for example, living in unsafe neighborhoods and attending schools that might not be so welcoming and safe,” said Dr. Edwards.

Safety first

Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.

Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.

The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.

The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.

Dr. Jill RachBeisel


Safety is of the utmost importance in the unit, Jill RachBeisel, MD, chief of psychiatry at UMMC and professor and chair in the department of psychiatry at UMSOM, said in an interview.

“Health care workers must recognize and respond to the effects of trauma – and one very important way is to provide care in settings that emphasize physical and emotional safety, which helps instill a sense of control and empowerment,” Dr. RachBeisel said.

Providing youth with options is an important way to provide that sense of control, Dr. Edwards added. For example, residents can choose their own music in their bedroom, such as sounds of nature, running water, or birds chirping. They can also draw or write personal notes on a large whiteboard in their unit.

Circadian-rhythm lighting

Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.

“We offer a really warm and welcoming environment that we think is going to promote health and healing,” said the unit’s head, Dr. Sarah Edwards.

These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.

A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.

The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.

Safe and empowering environments such as those created by the unit help young patients learn to manage their intense emotions and adopt productive behaviors and coping skills, Dr. Edwards noted.

The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
 

Advice for other centers

“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.

Unique elements of the new unit include walls painted soothing shades.

School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.

Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.

“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.

It is also important to incorporate feedback from youth themselves, Dr. Edwards added.

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

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Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.

The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.

Dr. Sarah Edwards


“We offer a really warm and welcoming environment that we think is going to promote health and healing,” the unit’s head, Sarah Edwards, DO, director of child and adolescent psychiatry at UMMC and assistant professor of psychiatry, University of Maryland School of Medicine (UMSOM), Baltimore, said in an interview.

Previous research shows that 1 in 4 children experience some kind of maltreatment, whether physical, sexual, or emotional, and that 1 in 5 develop a diagnosable mental health disorder.

The pandemic has added to the already stressful circumstances that many youth in Baltimore and elsewhere face, Dr. Edwards noted. Recent data show that the rate of suicidal ideation among youth has increased significantly during the COVID-19 crisis.

“Urban children have unfortunately suffered a lot of what we call traumatic stress, so they might be victims of physical or sexual abuse but also face layers of stressful situations – for example, living in unsafe neighborhoods and attending schools that might not be so welcoming and safe,” said Dr. Edwards.

Safety first

Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.

Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.

The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.

The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.

Dr. Jill RachBeisel


Safety is of the utmost importance in the unit, Jill RachBeisel, MD, chief of psychiatry at UMMC and professor and chair in the department of psychiatry at UMSOM, said in an interview.

“Health care workers must recognize and respond to the effects of trauma – and one very important way is to provide care in settings that emphasize physical and emotional safety, which helps instill a sense of control and empowerment,” Dr. RachBeisel said.

Providing youth with options is an important way to provide that sense of control, Dr. Edwards added. For example, residents can choose their own music in their bedroom, such as sounds of nature, running water, or birds chirping. They can also draw or write personal notes on a large whiteboard in their unit.

Circadian-rhythm lighting

Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.

“We offer a really warm and welcoming environment that we think is going to promote health and healing,” said the unit’s head, Dr. Sarah Edwards.

These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.

A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.

The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.

Safe and empowering environments such as those created by the unit help young patients learn to manage their intense emotions and adopt productive behaviors and coping skills, Dr. Edwards noted.

The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
 

Advice for other centers

“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.

Unique elements of the new unit include walls painted soothing shades.

School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.

Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.

“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.

It is also important to incorporate feedback from youth themselves, Dr. Edwards added.

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

Calming wall colors, nature-themed murals, and soft nighttime lighting are all part of a unique new state-of-the-art inpatient psychiatric unit that focuses especially on children and adolescents who have experienced significant trauma.

The 16-bed unit, which has been in the works for 3½ years and opened June 30 at the University of Maryland Medical Center (UMMC), in Baltimore, Maryland, treats youth aged 5 to 17 years. It has separate wings for younger children and for adolescents.

Dr. Sarah Edwards


“We offer a really warm and welcoming environment that we think is going to promote health and healing,” the unit’s head, Sarah Edwards, DO, director of child and adolescent psychiatry at UMMC and assistant professor of psychiatry, University of Maryland School of Medicine (UMSOM), Baltimore, said in an interview.

Previous research shows that 1 in 4 children experience some kind of maltreatment, whether physical, sexual, or emotional, and that 1 in 5 develop a diagnosable mental health disorder.

The pandemic has added to the already stressful circumstances that many youth in Baltimore and elsewhere face, Dr. Edwards noted. Recent data show that the rate of suicidal ideation among youth has increased significantly during the COVID-19 crisis.

“Urban children have unfortunately suffered a lot of what we call traumatic stress, so they might be victims of physical or sexual abuse but also face layers of stressful situations – for example, living in unsafe neighborhoods and attending schools that might not be so welcoming and safe,” said Dr. Edwards.

Safety first

Typical conditions treated at the new unit will include depression, anxiety, attention-deficit/hyperactivity disorder, psychotic spectrum, as well as trauma disorders.

Some of these young patients have been through the foster care system and show signs of trauma and poor attachment, Dr. Edwards noted. As a result, they may have difficulty regulating their thoughts and emotions and at times exhibit dangerous behavior.

The new unit is designed both architecturally and clinically to deliver “trauma-informed” care. This type of approach “recognizes the pervasive nature of trauma” and promotes settings that facilitate recovery, Dr. Edwards added.

The idea is to treat individuals “in a way that doesn’t re-traumatize them or make their condition worse,” she added.

Dr. Jill RachBeisel


Safety is of the utmost importance in the unit, Jill RachBeisel, MD, chief of psychiatry at UMMC and professor and chair in the department of psychiatry at UMSOM, said in an interview.

“Health care workers must recognize and respond to the effects of trauma – and one very important way is to provide care in settings that emphasize physical and emotional safety, which helps instill a sense of control and empowerment,” Dr. RachBeisel said.

Providing youth with options is an important way to provide that sense of control, Dr. Edwards added. For example, residents can choose their own music in their bedroom, such as sounds of nature, running water, or birds chirping. They can also draw or write personal notes on a large whiteboard in their unit.

Circadian-rhythm lighting

Other unique elements of the new unit include walls painted soothing shades and murals of natural scenery, created by a local artist.

“We offer a really warm and welcoming environment that we think is going to promote health and healing,” said the unit’s head, Dr. Sarah Edwards.

These murals perfectly capture “the kind of overall spirit of what we were trying to induce,” said Dr. Edwards.

A part of the unit dubbed the “front porch” has a large mural depicting “a landscape of beautiful trees and water and animals,” she noted. Kids can gather here to relax or just hang out.

The lighting at the unit mirrors circadian rhythms. It’s brighter during the day to promote wakefulness and participation in activities and gradually dims toward the evening hours to help induce restful nighttime sleep.

Safe and empowering environments such as those created by the unit help young patients learn to manage their intense emotions and adopt productive behaviors and coping skills, Dr. Edwards noted.

The staff for the interprofessional unit includes psychiatrists, psychologists, psychiatric nurses, occupational therapists, and others trained in pediatric care.
 

Advice for other centers

“Our new unit is designed to provide the highest standard in mental health care and incorporates a high-tech approach to create a calming, soothing, and engaging setting,” said Dr. RachBeisel.

Unique elements of the new unit include walls painted soothing shades.

School-transition specialists help connect discharged patients and their families to vital services and peer support. These services represent “an essential component of the continuum of care” for youth experiencing mental distress, she added.

Other organizations considering establishing a similar type of psychiatric unit should consult all stakeholders.

“We had staff, no matter what their role, be part of every step of this process, including helping with the design, picking out furniture they thought would make the most sense, and helping choose the artwork,” she said.

It is also important to incorporate feedback from youth themselves, Dr. Edwards added.

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

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New agents for youth-onset type 2 diabetes ‘finally in sight’

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Changed
Tue, 05/03/2022 - 15:05

There are limited treatment options for children and youth with type 2 diabetes, but a few novel therapies beyond metformin are on the horizon, experts said at the annual scientific sessions of the American Diabetes Association.

Dr. Kenneth Copeland

“Type 2 diabetes in youth only emerged as a well-recognized pediatric medical problem in the 1990s and the first decade of the 21st century,” session chair Kenneth C. Copeland, MD, said in an interview.

“Fortunately, a number of clinical trials of antidiabetic pharmacologic agents in diabetic youth have now been completed, demonstrating both safety and efficacy, and at long last, a ... variety of agents are finally in sight,” he noted.

Type 2 diabetes in youth is profoundly different from type 2 diabetes in adults, added Dr. Copeland, pediatrics professor emeritus, University of Oklahoma, Oklahoma City. In youth, its course is typically aggressive and refractive to treatment.

Concerted efforts at lifestyle intervention are important but insufficient, and a response to metformin, even when initiated at diagnosis, is often short lived, he added.

Because of the rapid glycemic deterioration that is typical of type 2 diabetes in youth and leads to the full array of diabetic complications, early aggressive pharmacologic treatment is indicated.

“We all look forward to this next decade ushering in new treatment options, spanning the spectrum from obesity prevention to complex pharmacologic intervention,” Dr. Copeland summarized.  
 

Increasing prevalence of T2D in youth, limited therapies

Rates of type 2 diabetes in youth continue to increase, especially among non-White groups, and most of these individuals have less than optimal diabetes control, Elvira Isganaitis, MD, MPH, a pediatric endocrinologist at the Joslin Diabetes Center and assistant professor of pediatrics at Harvard Medical School, both in Boston, told the meeting.

Dr. Elvira Isganaitis

Although the Food and Drug Administration has approved more than 25 drugs to treat type 2 diabetes in adults, “unfortunately,” metformin is the only oral medication approved to treat the disease in a pediatric population, “and a majority of youth either do not respond to it or do not tolerate it,” she said in an interview.

Dr. Copeland observed that “the TODAY study demonstrated conclusively that, despite an often dramatic initial improvement in glycemic control upon initiation of pharmacologic and lifestyle intervention, this initial response was followed by a rapid deterioration of beta-cell function and glycemic failure, indicating that additional pharmacologic agents were sorely needed for this population.”

The RISE study also showed that, compared with adults, youth had more rapid beta-cell deterioration despite treatment. 

Until the June 2019 FDA approval of the injectable glucagonlike peptide–1 receptor agonist liraglutide (Victoza, Novo Nordisk) for children 10 years or older, “except for insulin, metformin was the only antidiabetic medication available for use in youth, severely limiting treatment options,” he added.
 

Liraglutide ‘a huge breakthrough,’ other options on the horizon

The FDA approval of liraglutide was “a huge breakthrough” as the first noninsulin drug for pediatric type 2 diabetes since metformin was approved for pediatric use in 2000, Dr. Isganaitis said.

The ELLIPSE study, on which the approval was based, showed liraglutide was effective at lowering hemoglobin A1c and was generally well tolerated, although it was associated with a higher incidence of gastrointestinal symptoms. 

In December 2020, the FDA also approved liraglutide (Saxenda) for the treatment of obesity in youth age 12 and older (at a dose of 3 mg as opposed to the 1.8-mg dose of liraglutide [Victoza]), “which is wonderful news considering that the majority of pediatric patients with type 2 diabetes also have obesity,” Dr. Isganaitis added.

“The results of studies of liraglutide on glycemia in diabetic youth are impressive, with both an additional benefit of weight loss and without unacceptable identified risks or side effects,” Dr. Copeland concurred.
 

Waiting in the wings

Dr. Isganaitis reported that a few phase 3 clinical trials of other therapies for pediatric patients with type 2 diabetes are in the wings.

The 24-week phase 3 T2GO clinical trial of the sodium-glucose cotransporter 2 inhibitor dapagliflozin (AstraZeneca) versus placebo in 72 patients with type 2 diabetes aged 10-24 years was completed in April 2020, and the data are being analyzed.

An AstraZeneca-sponsored phase 3 trial of the safety and efficacy of a weekly injection of the GLP-1 receptor agonist exenatide in 10- to 17-year-olds with type 2 diabetes (n = 82) has also been completed and data are being analyzed.

A Takeda-sponsored phase 3 pediatric study of the dipeptidyl peptidase–4 inhibitor alogliptin in 10- to 17-year-olds with type 2 diabetes (n = 150) is estimated to be completed by February 2022.

And the phase 3 DINAMO trial, sponsored by Boehringer Ingelheim, which is evaluating the efficacy and safety of the SGLT2 inhibitor empagliflozin (10 mg/25 mg) versus the DPP-4 inhibitor linagliptin (5 mg) versus placebo over 26 weeks in 10- to 17-year-olds with type 2 diabetes (estimated 186 participants), is expected to be completed in May 2023.

“I hope that these medications will demonstrate efficacy and allow pediatric patients with type 2 diabetes to have more treatment options,” Dr. Isganaitis concluded.
 

Type 2 diabetes more aggressive than type 1 diabetes in kids

According to Dr. Isganaitis, “there is a widely held misconception among the general public and even among some physicians that type 2 diabetes is somehow less worrisome or ‘milder’ than a diagnosis of type 1 diabetes.”

However, the risk of complications and severe morbidity is higher with a diagnosis of type 2 diabetes versus type 1 diabetes in a child, so “this condition needs to be managed intensively with a multidisciplinary team including pediatric endocrinology, nutrition [support], diabetes educators, and mental health support,” she emphasized.

Many people also believe that “type 2 diabetes in kids is a ‘lifestyle disease,’ ” she continued, “but in fact, there is a strong role for genetics.”

The ADA Presidents’ Select Abstract “paints a picture of youth-onset type 2 diabetes as a disease intermediate in extremity between monogenic diabetes [caused by mutations in a single gene] and type 2 diabetes [caused by multiple genes and lifestyle factors such as obesity], in which genetic variants in both insulin secretion and insulin response pathways are implicated.”

Along the same lines, Dr. Isganaitis presented an oral abstract at the meeting that showed that, among youth with newly diagnosed type 2 diabetes, those whose mothers had diabetes had faster disease progression and earlier onset of diabetes complications.

Dr. Isganaitis has reported no relevant financial relationships. Dr. Copeland has reported serving on data monitoring committees for Boehringer Ingelheim and Novo Nordisk, and on an advisory committee for a research study for Daiichi Sankyo.

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

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There are limited treatment options for children and youth with type 2 diabetes, but a few novel therapies beyond metformin are on the horizon, experts said at the annual scientific sessions of the American Diabetes Association.

Dr. Kenneth Copeland

“Type 2 diabetes in youth only emerged as a well-recognized pediatric medical problem in the 1990s and the first decade of the 21st century,” session chair Kenneth C. Copeland, MD, said in an interview.

“Fortunately, a number of clinical trials of antidiabetic pharmacologic agents in diabetic youth have now been completed, demonstrating both safety and efficacy, and at long last, a ... variety of agents are finally in sight,” he noted.

Type 2 diabetes in youth is profoundly different from type 2 diabetes in adults, added Dr. Copeland, pediatrics professor emeritus, University of Oklahoma, Oklahoma City. In youth, its course is typically aggressive and refractive to treatment.

Concerted efforts at lifestyle intervention are important but insufficient, and a response to metformin, even when initiated at diagnosis, is often short lived, he added.

Because of the rapid glycemic deterioration that is typical of type 2 diabetes in youth and leads to the full array of diabetic complications, early aggressive pharmacologic treatment is indicated.

“We all look forward to this next decade ushering in new treatment options, spanning the spectrum from obesity prevention to complex pharmacologic intervention,” Dr. Copeland summarized.  
 

Increasing prevalence of T2D in youth, limited therapies

Rates of type 2 diabetes in youth continue to increase, especially among non-White groups, and most of these individuals have less than optimal diabetes control, Elvira Isganaitis, MD, MPH, a pediatric endocrinologist at the Joslin Diabetes Center and assistant professor of pediatrics at Harvard Medical School, both in Boston, told the meeting.

Dr. Elvira Isganaitis

Although the Food and Drug Administration has approved more than 25 drugs to treat type 2 diabetes in adults, “unfortunately,” metformin is the only oral medication approved to treat the disease in a pediatric population, “and a majority of youth either do not respond to it or do not tolerate it,” she said in an interview.

Dr. Copeland observed that “the TODAY study demonstrated conclusively that, despite an often dramatic initial improvement in glycemic control upon initiation of pharmacologic and lifestyle intervention, this initial response was followed by a rapid deterioration of beta-cell function and glycemic failure, indicating that additional pharmacologic agents were sorely needed for this population.”

The RISE study also showed that, compared with adults, youth had more rapid beta-cell deterioration despite treatment. 

Until the June 2019 FDA approval of the injectable glucagonlike peptide–1 receptor agonist liraglutide (Victoza, Novo Nordisk) for children 10 years or older, “except for insulin, metformin was the only antidiabetic medication available for use in youth, severely limiting treatment options,” he added.
 

Liraglutide ‘a huge breakthrough,’ other options on the horizon

The FDA approval of liraglutide was “a huge breakthrough” as the first noninsulin drug for pediatric type 2 diabetes since metformin was approved for pediatric use in 2000, Dr. Isganaitis said.

The ELLIPSE study, on which the approval was based, showed liraglutide was effective at lowering hemoglobin A1c and was generally well tolerated, although it was associated with a higher incidence of gastrointestinal symptoms. 

In December 2020, the FDA also approved liraglutide (Saxenda) for the treatment of obesity in youth age 12 and older (at a dose of 3 mg as opposed to the 1.8-mg dose of liraglutide [Victoza]), “which is wonderful news considering that the majority of pediatric patients with type 2 diabetes also have obesity,” Dr. Isganaitis added.

“The results of studies of liraglutide on glycemia in diabetic youth are impressive, with both an additional benefit of weight loss and without unacceptable identified risks or side effects,” Dr. Copeland concurred.
 

Waiting in the wings

Dr. Isganaitis reported that a few phase 3 clinical trials of other therapies for pediatric patients with type 2 diabetes are in the wings.

The 24-week phase 3 T2GO clinical trial of the sodium-glucose cotransporter 2 inhibitor dapagliflozin (AstraZeneca) versus placebo in 72 patients with type 2 diabetes aged 10-24 years was completed in April 2020, and the data are being analyzed.

An AstraZeneca-sponsored phase 3 trial of the safety and efficacy of a weekly injection of the GLP-1 receptor agonist exenatide in 10- to 17-year-olds with type 2 diabetes (n = 82) has also been completed and data are being analyzed.

A Takeda-sponsored phase 3 pediatric study of the dipeptidyl peptidase–4 inhibitor alogliptin in 10- to 17-year-olds with type 2 diabetes (n = 150) is estimated to be completed by February 2022.

And the phase 3 DINAMO trial, sponsored by Boehringer Ingelheim, which is evaluating the efficacy and safety of the SGLT2 inhibitor empagliflozin (10 mg/25 mg) versus the DPP-4 inhibitor linagliptin (5 mg) versus placebo over 26 weeks in 10- to 17-year-olds with type 2 diabetes (estimated 186 participants), is expected to be completed in May 2023.

“I hope that these medications will demonstrate efficacy and allow pediatric patients with type 2 diabetes to have more treatment options,” Dr. Isganaitis concluded.
 

Type 2 diabetes more aggressive than type 1 diabetes in kids

According to Dr. Isganaitis, “there is a widely held misconception among the general public and even among some physicians that type 2 diabetes is somehow less worrisome or ‘milder’ than a diagnosis of type 1 diabetes.”

However, the risk of complications and severe morbidity is higher with a diagnosis of type 2 diabetes versus type 1 diabetes in a child, so “this condition needs to be managed intensively with a multidisciplinary team including pediatric endocrinology, nutrition [support], diabetes educators, and mental health support,” she emphasized.

Many people also believe that “type 2 diabetes in kids is a ‘lifestyle disease,’ ” she continued, “but in fact, there is a strong role for genetics.”

The ADA Presidents’ Select Abstract “paints a picture of youth-onset type 2 diabetes as a disease intermediate in extremity between monogenic diabetes [caused by mutations in a single gene] and type 2 diabetes [caused by multiple genes and lifestyle factors such as obesity], in which genetic variants in both insulin secretion and insulin response pathways are implicated.”

Along the same lines, Dr. Isganaitis presented an oral abstract at the meeting that showed that, among youth with newly diagnosed type 2 diabetes, those whose mothers had diabetes had faster disease progression and earlier onset of diabetes complications.

Dr. Isganaitis has reported no relevant financial relationships. Dr. Copeland has reported serving on data monitoring committees for Boehringer Ingelheim and Novo Nordisk, and on an advisory committee for a research study for Daiichi Sankyo.

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

There are limited treatment options for children and youth with type 2 diabetes, but a few novel therapies beyond metformin are on the horizon, experts said at the annual scientific sessions of the American Diabetes Association.

Dr. Kenneth Copeland

“Type 2 diabetes in youth only emerged as a well-recognized pediatric medical problem in the 1990s and the first decade of the 21st century,” session chair Kenneth C. Copeland, MD, said in an interview.

“Fortunately, a number of clinical trials of antidiabetic pharmacologic agents in diabetic youth have now been completed, demonstrating both safety and efficacy, and at long last, a ... variety of agents are finally in sight,” he noted.

Type 2 diabetes in youth is profoundly different from type 2 diabetes in adults, added Dr. Copeland, pediatrics professor emeritus, University of Oklahoma, Oklahoma City. In youth, its course is typically aggressive and refractive to treatment.

Concerted efforts at lifestyle intervention are important but insufficient, and a response to metformin, even when initiated at diagnosis, is often short lived, he added.

Because of the rapid glycemic deterioration that is typical of type 2 diabetes in youth and leads to the full array of diabetic complications, early aggressive pharmacologic treatment is indicated.

“We all look forward to this next decade ushering in new treatment options, spanning the spectrum from obesity prevention to complex pharmacologic intervention,” Dr. Copeland summarized.  
 

Increasing prevalence of T2D in youth, limited therapies

Rates of type 2 diabetes in youth continue to increase, especially among non-White groups, and most of these individuals have less than optimal diabetes control, Elvira Isganaitis, MD, MPH, a pediatric endocrinologist at the Joslin Diabetes Center and assistant professor of pediatrics at Harvard Medical School, both in Boston, told the meeting.

Dr. Elvira Isganaitis

Although the Food and Drug Administration has approved more than 25 drugs to treat type 2 diabetes in adults, “unfortunately,” metformin is the only oral medication approved to treat the disease in a pediatric population, “and a majority of youth either do not respond to it or do not tolerate it,” she said in an interview.

Dr. Copeland observed that “the TODAY study demonstrated conclusively that, despite an often dramatic initial improvement in glycemic control upon initiation of pharmacologic and lifestyle intervention, this initial response was followed by a rapid deterioration of beta-cell function and glycemic failure, indicating that additional pharmacologic agents were sorely needed for this population.”

The RISE study also showed that, compared with adults, youth had more rapid beta-cell deterioration despite treatment. 

Until the June 2019 FDA approval of the injectable glucagonlike peptide–1 receptor agonist liraglutide (Victoza, Novo Nordisk) for children 10 years or older, “except for insulin, metformin was the only antidiabetic medication available for use in youth, severely limiting treatment options,” he added.
 

Liraglutide ‘a huge breakthrough,’ other options on the horizon

The FDA approval of liraglutide was “a huge breakthrough” as the first noninsulin drug for pediatric type 2 diabetes since metformin was approved for pediatric use in 2000, Dr. Isganaitis said.

The ELLIPSE study, on which the approval was based, showed liraglutide was effective at lowering hemoglobin A1c and was generally well tolerated, although it was associated with a higher incidence of gastrointestinal symptoms. 

In December 2020, the FDA also approved liraglutide (Saxenda) for the treatment of obesity in youth age 12 and older (at a dose of 3 mg as opposed to the 1.8-mg dose of liraglutide [Victoza]), “which is wonderful news considering that the majority of pediatric patients with type 2 diabetes also have obesity,” Dr. Isganaitis added.

“The results of studies of liraglutide on glycemia in diabetic youth are impressive, with both an additional benefit of weight loss and without unacceptable identified risks or side effects,” Dr. Copeland concurred.
 

Waiting in the wings

Dr. Isganaitis reported that a few phase 3 clinical trials of other therapies for pediatric patients with type 2 diabetes are in the wings.

The 24-week phase 3 T2GO clinical trial of the sodium-glucose cotransporter 2 inhibitor dapagliflozin (AstraZeneca) versus placebo in 72 patients with type 2 diabetes aged 10-24 years was completed in April 2020, and the data are being analyzed.

An AstraZeneca-sponsored phase 3 trial of the safety and efficacy of a weekly injection of the GLP-1 receptor agonist exenatide in 10- to 17-year-olds with type 2 diabetes (n = 82) has also been completed and data are being analyzed.

A Takeda-sponsored phase 3 pediatric study of the dipeptidyl peptidase–4 inhibitor alogliptin in 10- to 17-year-olds with type 2 diabetes (n = 150) is estimated to be completed by February 2022.

And the phase 3 DINAMO trial, sponsored by Boehringer Ingelheim, which is evaluating the efficacy and safety of the SGLT2 inhibitor empagliflozin (10 mg/25 mg) versus the DPP-4 inhibitor linagliptin (5 mg) versus placebo over 26 weeks in 10- to 17-year-olds with type 2 diabetes (estimated 186 participants), is expected to be completed in May 2023.

“I hope that these medications will demonstrate efficacy and allow pediatric patients with type 2 diabetes to have more treatment options,” Dr. Isganaitis concluded.
 

Type 2 diabetes more aggressive than type 1 diabetes in kids

According to Dr. Isganaitis, “there is a widely held misconception among the general public and even among some physicians that type 2 diabetes is somehow less worrisome or ‘milder’ than a diagnosis of type 1 diabetes.”

However, the risk of complications and severe morbidity is higher with a diagnosis of type 2 diabetes versus type 1 diabetes in a child, so “this condition needs to be managed intensively with a multidisciplinary team including pediatric endocrinology, nutrition [support], diabetes educators, and mental health support,” she emphasized.

Many people also believe that “type 2 diabetes in kids is a ‘lifestyle disease,’ ” she continued, “but in fact, there is a strong role for genetics.”

The ADA Presidents’ Select Abstract “paints a picture of youth-onset type 2 diabetes as a disease intermediate in extremity between monogenic diabetes [caused by mutations in a single gene] and type 2 diabetes [caused by multiple genes and lifestyle factors such as obesity], in which genetic variants in both insulin secretion and insulin response pathways are implicated.”

Along the same lines, Dr. Isganaitis presented an oral abstract at the meeting that showed that, among youth with newly diagnosed type 2 diabetes, those whose mothers had diabetes had faster disease progression and earlier onset of diabetes complications.

Dr. Isganaitis has reported no relevant financial relationships. Dr. Copeland has reported serving on data monitoring committees for Boehringer Ingelheim and Novo Nordisk, and on an advisory committee for a research study for Daiichi Sankyo.

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

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