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Is education or screening better for type 1 diabetes?
After 100 years of insulin therapy, teplizumab, an immunotherapy for early-stage type 1 diabetes, has been approved for the first time in the United States and has been shown to delay the manifestation of clinical diabetes by 3 years on average. at the Diabetes Congress in Berlin.
Anette-Gabriele Ziegler, MD, PhD, director of the Institute for Diabetes Research in Helmholtz Munich, argued that voluntary screening for type 1 diabetes should be included in standard care. “The first immunotherapy that delays type 1 diabetes has been approved in the U.S. for early stage 2. And this early stage can only be identified through prior screening, since no symptoms have manifested by this stage,” she said. This is the only way in which as many people as possible, particularly children, will benefit from the disease-delaying therapy, she added.
Two autoantibodies
One biomarker for the early diagnosis of type 1 diabetes is evidence of at least two positive islet cell antibodies. In one study of more than 13,000 children who were observed for 20 years, the specificity of these antibodies was 100%. “Every single child with a positive autoantibody test developed type 1 diabetes later on in their life,” Dr. Ziegler said. “Based on the results of this study, the early stages of type 1 diabetes were added to multiple guidelines.”
The early stage of type 1 diabetes is divided into the following three phases, depending on autoantibody detection and the level of glucose metabolism:
- Early stage 1: Two or more islet autoantibodies and normoglycemia.
- Early stage 2: Two or more islet autoantibodies and dysglycemia.
- Early stage 3: Symptoms, hyperglycemia, insulin therapy.
The aim of the ongoing FR1DA study is to ascertain whether the general population could also be screened for type 1 diabetes using this autoantibody. “Since 2015, children of kindergarten and school age have undergone screening, and to date, more than 170,000 have been tested,” said Dr. Ziegler. “At least two autoantibodies were detected in 0.3% of those screened.”
Education and care
The families of the children in whom early-stage type 1 diabetes was diagnosed were invited to take an oral glucose tolerance test (OGTT), to undergo measurement of hemoglobin A1c, and to take part in training and monitoring. “Education and competent, ongoing care are crucial for the efficacy of the screening,” Dr. Ziegler emphasized.
The OGTT revealed that 85% of the FR1DA children were still in early stage 1, another 11% were in early stage 2, and the remaining 4% were in early stage 3.
“Unfortunately, the 4% could no longer benefit from teplizumab, since the medication is not approved for manifest diabetes,” said Dr. Ziegler. “However, the 11% could receive teplizumab immediately, and then later on, the 85%, when they developed stage 2. Therefore, further observation of the children is also important.”
The speed at which the disease progresses from early stage 1 to early stage 2 can be stratified using IA2 antibodies, the 90-minute OGTT glucose value, and the HbA1c value. With regard to progression to clinical type 1 diabetes (stage 3), it was observed that the progression risk for the FR1DA children was similar to that of international birth cohorts with increased genetic risk. “Of course, there is still no 20-year follow-up like for BABYDIAB, DIPP, and DAISY, but as of yet, the progression rate is practically identical,” said Dr. Ziegler.
Dubious benefits?
The advantages of screening for type 1 diabetes would not be limited to potential access to preventive therapies and a smooth transition to insulin therapy at the correct point in time, according to Dr. Ziegler. Participation in the FR1DA study dramatically reduced the risk of diabetic ketoacidosis (DKA). Between 2015 and 2023, the overall rate of ketoacidosis associated with the manifestation of clinical type 1 diabetes was 4.3%. In contrast, the general DKA rate in Germany has remained largely unchanged for the last 2 decades at between 20% and 25%.
In addition, the FR1DA children exhibited better beta cell function and better metabolic function at clinical diagnosis of type 1 diabetes. This finding was observed in a comparison with children with a spontaneous diabetes diagnosis from the DiMelli study. “It is important that there is a lot of data that shows how, in the long term, this is associated with a better morbidity and mortality,” said Dr. Ziegler.
Despite the impressive data from the FR1DA study, not all diabetes experts are convinced that a general screening for type 1 diabetes would be beneficial. Beate Karges, MD, PhD, of the Clinic for Pediatric and Adolescent Medicine of the Bethlehem Hospital Stolberg (Germany) and the endocrinology and diabetology department at the University Hospital Aachen (Germany), stressed, “Screening makes sense if the disease is curable in the preclinical phase or if there is a significantly better prognosis in the event of early diagnosis and treatment.”
Severe side effects
Even with an early-stage diagnosis, curing type 1 diabetes is impossible. The new anti-CD3 antibody teplizumab merely delays the manifestation of symptoms for 3 years. However, this delay has its price. The summary of product characteristics for teplizumab contains warnings of severe lymphopenia lasting many weeks, cytokine release syndrome, severe infections, and hypersensitivity reactions. Furthermore, vaccinations may not be administered during teplizumab treatment and therefore must be completed in advance.
“Preventing type 1 diabetes is still not possible, we can only delay it, and the long-term efficacy and safety of this immunotherapy are not clear,” said Dr. Karges. She added that a significant reduction in the DKA rate – as observed in the FR1DA study – may be possible even without screening. This possibility was demonstrated by a model project in Stuttgart, Germany, in which the DKA rate was significantly reduced through education alone.
Education reduces ketoacidosis
“The families were given information about the early signs of type 1 diabetes during the education investigation. Through this [education], a reduction in the ketoacidosis rate from 28% to 16% was achieved,” said Dr. Karges. It is also known from studies of familial type 1 diabetes that secondary sufferers in the family only exhibit a DKA rate of 7%. “Through education within the family and awareness campaigns, the DKA rate can be reduced by 40%-65%,” said Dr. Karges.
Dr. Karges also doubts whether starting insulin therapy earlier “at the correct point in time” elicits long-term advantages. Secondary sufferers with familial type 1 diabetes have better HbA1c values in the first few years after diagnosis. “But as they progress beyond 2, towards 10 years, the difference in HbA1c values diminishes,” said Dr. Karges.
Whether the patient has DKA at type 1 diabetes diagnosis also seems to make little difference in the long term. “There is also no difference in the HbA1c value in the 2-10 years after diagnosis,” said Dr. Karges. “Glycemic control is not permanently improved in the event that treatment is started early,” she concluded.
“Type 1 diabetes can be delayed with an immune intervention, but to do so, we must also accept possible severe side effects in an otherwise healthy child,” she said. On the other hand, type 1 diabetes can be treated well. “With pumps and continuous glucose monitoring, insulin therapy in children and adolescents has become significantly safer and more effective,” she said.
New therapeutic options
Whether voluntary screening for type 1 diabetes eventually finds its way into standard care depends on the further development of preventive medications. Dr. Ziegler stressed that future preventive therapy does not need to be limited to the anti-CD3 antibody teplizumab.
For example, strategies such as high-dose oral insulin therapy are being investigated. Verapamil, which is used to treat hypertension, is also promising, since with it, beta cells were retained in early stage 3, and it improved their function. The fusion protein abatacept fell short of statistical significance in a recently published study. For Dr. Ziegler, one thing remains true. “The therapy of type 1 diabetes is about to undergo a renaissance.”
This article was translated from the Medscape German Edition. A version of this article appeared on Medscape.com.
After 100 years of insulin therapy, teplizumab, an immunotherapy for early-stage type 1 diabetes, has been approved for the first time in the United States and has been shown to delay the manifestation of clinical diabetes by 3 years on average. at the Diabetes Congress in Berlin.
Anette-Gabriele Ziegler, MD, PhD, director of the Institute for Diabetes Research in Helmholtz Munich, argued that voluntary screening for type 1 diabetes should be included in standard care. “The first immunotherapy that delays type 1 diabetes has been approved in the U.S. for early stage 2. And this early stage can only be identified through prior screening, since no symptoms have manifested by this stage,” she said. This is the only way in which as many people as possible, particularly children, will benefit from the disease-delaying therapy, she added.
Two autoantibodies
One biomarker for the early diagnosis of type 1 diabetes is evidence of at least two positive islet cell antibodies. In one study of more than 13,000 children who were observed for 20 years, the specificity of these antibodies was 100%. “Every single child with a positive autoantibody test developed type 1 diabetes later on in their life,” Dr. Ziegler said. “Based on the results of this study, the early stages of type 1 diabetes were added to multiple guidelines.”
The early stage of type 1 diabetes is divided into the following three phases, depending on autoantibody detection and the level of glucose metabolism:
- Early stage 1: Two or more islet autoantibodies and normoglycemia.
- Early stage 2: Two or more islet autoantibodies and dysglycemia.
- Early stage 3: Symptoms, hyperglycemia, insulin therapy.
The aim of the ongoing FR1DA study is to ascertain whether the general population could also be screened for type 1 diabetes using this autoantibody. “Since 2015, children of kindergarten and school age have undergone screening, and to date, more than 170,000 have been tested,” said Dr. Ziegler. “At least two autoantibodies were detected in 0.3% of those screened.”
Education and care
The families of the children in whom early-stage type 1 diabetes was diagnosed were invited to take an oral glucose tolerance test (OGTT), to undergo measurement of hemoglobin A1c, and to take part in training and monitoring. “Education and competent, ongoing care are crucial for the efficacy of the screening,” Dr. Ziegler emphasized.
The OGTT revealed that 85% of the FR1DA children were still in early stage 1, another 11% were in early stage 2, and the remaining 4% were in early stage 3.
“Unfortunately, the 4% could no longer benefit from teplizumab, since the medication is not approved for manifest diabetes,” said Dr. Ziegler. “However, the 11% could receive teplizumab immediately, and then later on, the 85%, when they developed stage 2. Therefore, further observation of the children is also important.”
The speed at which the disease progresses from early stage 1 to early stage 2 can be stratified using IA2 antibodies, the 90-minute OGTT glucose value, and the HbA1c value. With regard to progression to clinical type 1 diabetes (stage 3), it was observed that the progression risk for the FR1DA children was similar to that of international birth cohorts with increased genetic risk. “Of course, there is still no 20-year follow-up like for BABYDIAB, DIPP, and DAISY, but as of yet, the progression rate is practically identical,” said Dr. Ziegler.
Dubious benefits?
The advantages of screening for type 1 diabetes would not be limited to potential access to preventive therapies and a smooth transition to insulin therapy at the correct point in time, according to Dr. Ziegler. Participation in the FR1DA study dramatically reduced the risk of diabetic ketoacidosis (DKA). Between 2015 and 2023, the overall rate of ketoacidosis associated with the manifestation of clinical type 1 diabetes was 4.3%. In contrast, the general DKA rate in Germany has remained largely unchanged for the last 2 decades at between 20% and 25%.
In addition, the FR1DA children exhibited better beta cell function and better metabolic function at clinical diagnosis of type 1 diabetes. This finding was observed in a comparison with children with a spontaneous diabetes diagnosis from the DiMelli study. “It is important that there is a lot of data that shows how, in the long term, this is associated with a better morbidity and mortality,” said Dr. Ziegler.
Despite the impressive data from the FR1DA study, not all diabetes experts are convinced that a general screening for type 1 diabetes would be beneficial. Beate Karges, MD, PhD, of the Clinic for Pediatric and Adolescent Medicine of the Bethlehem Hospital Stolberg (Germany) and the endocrinology and diabetology department at the University Hospital Aachen (Germany), stressed, “Screening makes sense if the disease is curable in the preclinical phase or if there is a significantly better prognosis in the event of early diagnosis and treatment.”
Severe side effects
Even with an early-stage diagnosis, curing type 1 diabetes is impossible. The new anti-CD3 antibody teplizumab merely delays the manifestation of symptoms for 3 years. However, this delay has its price. The summary of product characteristics for teplizumab contains warnings of severe lymphopenia lasting many weeks, cytokine release syndrome, severe infections, and hypersensitivity reactions. Furthermore, vaccinations may not be administered during teplizumab treatment and therefore must be completed in advance.
“Preventing type 1 diabetes is still not possible, we can only delay it, and the long-term efficacy and safety of this immunotherapy are not clear,” said Dr. Karges. She added that a significant reduction in the DKA rate – as observed in the FR1DA study – may be possible even without screening. This possibility was demonstrated by a model project in Stuttgart, Germany, in which the DKA rate was significantly reduced through education alone.
Education reduces ketoacidosis
“The families were given information about the early signs of type 1 diabetes during the education investigation. Through this [education], a reduction in the ketoacidosis rate from 28% to 16% was achieved,” said Dr. Karges. It is also known from studies of familial type 1 diabetes that secondary sufferers in the family only exhibit a DKA rate of 7%. “Through education within the family and awareness campaigns, the DKA rate can be reduced by 40%-65%,” said Dr. Karges.
Dr. Karges also doubts whether starting insulin therapy earlier “at the correct point in time” elicits long-term advantages. Secondary sufferers with familial type 1 diabetes have better HbA1c values in the first few years after diagnosis. “But as they progress beyond 2, towards 10 years, the difference in HbA1c values diminishes,” said Dr. Karges.
Whether the patient has DKA at type 1 diabetes diagnosis also seems to make little difference in the long term. “There is also no difference in the HbA1c value in the 2-10 years after diagnosis,” said Dr. Karges. “Glycemic control is not permanently improved in the event that treatment is started early,” she concluded.
“Type 1 diabetes can be delayed with an immune intervention, but to do so, we must also accept possible severe side effects in an otherwise healthy child,” she said. On the other hand, type 1 diabetes can be treated well. “With pumps and continuous glucose monitoring, insulin therapy in children and adolescents has become significantly safer and more effective,” she said.
New therapeutic options
Whether voluntary screening for type 1 diabetes eventually finds its way into standard care depends on the further development of preventive medications. Dr. Ziegler stressed that future preventive therapy does not need to be limited to the anti-CD3 antibody teplizumab.
For example, strategies such as high-dose oral insulin therapy are being investigated. Verapamil, which is used to treat hypertension, is also promising, since with it, beta cells were retained in early stage 3, and it improved their function. The fusion protein abatacept fell short of statistical significance in a recently published study. For Dr. Ziegler, one thing remains true. “The therapy of type 1 diabetes is about to undergo a renaissance.”
This article was translated from the Medscape German Edition. A version of this article appeared on Medscape.com.
After 100 years of insulin therapy, teplizumab, an immunotherapy for early-stage type 1 diabetes, has been approved for the first time in the United States and has been shown to delay the manifestation of clinical diabetes by 3 years on average. at the Diabetes Congress in Berlin.
Anette-Gabriele Ziegler, MD, PhD, director of the Institute for Diabetes Research in Helmholtz Munich, argued that voluntary screening for type 1 diabetes should be included in standard care. “The first immunotherapy that delays type 1 diabetes has been approved in the U.S. for early stage 2. And this early stage can only be identified through prior screening, since no symptoms have manifested by this stage,” she said. This is the only way in which as many people as possible, particularly children, will benefit from the disease-delaying therapy, she added.
Two autoantibodies
One biomarker for the early diagnosis of type 1 diabetes is evidence of at least two positive islet cell antibodies. In one study of more than 13,000 children who were observed for 20 years, the specificity of these antibodies was 100%. “Every single child with a positive autoantibody test developed type 1 diabetes later on in their life,” Dr. Ziegler said. “Based on the results of this study, the early stages of type 1 diabetes were added to multiple guidelines.”
The early stage of type 1 diabetes is divided into the following three phases, depending on autoantibody detection and the level of glucose metabolism:
- Early stage 1: Two or more islet autoantibodies and normoglycemia.
- Early stage 2: Two or more islet autoantibodies and dysglycemia.
- Early stage 3: Symptoms, hyperglycemia, insulin therapy.
The aim of the ongoing FR1DA study is to ascertain whether the general population could also be screened for type 1 diabetes using this autoantibody. “Since 2015, children of kindergarten and school age have undergone screening, and to date, more than 170,000 have been tested,” said Dr. Ziegler. “At least two autoantibodies were detected in 0.3% of those screened.”
Education and care
The families of the children in whom early-stage type 1 diabetes was diagnosed were invited to take an oral glucose tolerance test (OGTT), to undergo measurement of hemoglobin A1c, and to take part in training and monitoring. “Education and competent, ongoing care are crucial for the efficacy of the screening,” Dr. Ziegler emphasized.
The OGTT revealed that 85% of the FR1DA children were still in early stage 1, another 11% were in early stage 2, and the remaining 4% were in early stage 3.
“Unfortunately, the 4% could no longer benefit from teplizumab, since the medication is not approved for manifest diabetes,” said Dr. Ziegler. “However, the 11% could receive teplizumab immediately, and then later on, the 85%, when they developed stage 2. Therefore, further observation of the children is also important.”
The speed at which the disease progresses from early stage 1 to early stage 2 can be stratified using IA2 antibodies, the 90-minute OGTT glucose value, and the HbA1c value. With regard to progression to clinical type 1 diabetes (stage 3), it was observed that the progression risk for the FR1DA children was similar to that of international birth cohorts with increased genetic risk. “Of course, there is still no 20-year follow-up like for BABYDIAB, DIPP, and DAISY, but as of yet, the progression rate is practically identical,” said Dr. Ziegler.
Dubious benefits?
The advantages of screening for type 1 diabetes would not be limited to potential access to preventive therapies and a smooth transition to insulin therapy at the correct point in time, according to Dr. Ziegler. Participation in the FR1DA study dramatically reduced the risk of diabetic ketoacidosis (DKA). Between 2015 and 2023, the overall rate of ketoacidosis associated with the manifestation of clinical type 1 diabetes was 4.3%. In contrast, the general DKA rate in Germany has remained largely unchanged for the last 2 decades at between 20% and 25%.
In addition, the FR1DA children exhibited better beta cell function and better metabolic function at clinical diagnosis of type 1 diabetes. This finding was observed in a comparison with children with a spontaneous diabetes diagnosis from the DiMelli study. “It is important that there is a lot of data that shows how, in the long term, this is associated with a better morbidity and mortality,” said Dr. Ziegler.
Despite the impressive data from the FR1DA study, not all diabetes experts are convinced that a general screening for type 1 diabetes would be beneficial. Beate Karges, MD, PhD, of the Clinic for Pediatric and Adolescent Medicine of the Bethlehem Hospital Stolberg (Germany) and the endocrinology and diabetology department at the University Hospital Aachen (Germany), stressed, “Screening makes sense if the disease is curable in the preclinical phase or if there is a significantly better prognosis in the event of early diagnosis and treatment.”
Severe side effects
Even with an early-stage diagnosis, curing type 1 diabetes is impossible. The new anti-CD3 antibody teplizumab merely delays the manifestation of symptoms for 3 years. However, this delay has its price. The summary of product characteristics for teplizumab contains warnings of severe lymphopenia lasting many weeks, cytokine release syndrome, severe infections, and hypersensitivity reactions. Furthermore, vaccinations may not be administered during teplizumab treatment and therefore must be completed in advance.
“Preventing type 1 diabetes is still not possible, we can only delay it, and the long-term efficacy and safety of this immunotherapy are not clear,” said Dr. Karges. She added that a significant reduction in the DKA rate – as observed in the FR1DA study – may be possible even without screening. This possibility was demonstrated by a model project in Stuttgart, Germany, in which the DKA rate was significantly reduced through education alone.
Education reduces ketoacidosis
“The families were given information about the early signs of type 1 diabetes during the education investigation. Through this [education], a reduction in the ketoacidosis rate from 28% to 16% was achieved,” said Dr. Karges. It is also known from studies of familial type 1 diabetes that secondary sufferers in the family only exhibit a DKA rate of 7%. “Through education within the family and awareness campaigns, the DKA rate can be reduced by 40%-65%,” said Dr. Karges.
Dr. Karges also doubts whether starting insulin therapy earlier “at the correct point in time” elicits long-term advantages. Secondary sufferers with familial type 1 diabetes have better HbA1c values in the first few years after diagnosis. “But as they progress beyond 2, towards 10 years, the difference in HbA1c values diminishes,” said Dr. Karges.
Whether the patient has DKA at type 1 diabetes diagnosis also seems to make little difference in the long term. “There is also no difference in the HbA1c value in the 2-10 years after diagnosis,” said Dr. Karges. “Glycemic control is not permanently improved in the event that treatment is started early,” she concluded.
“Type 1 diabetes can be delayed with an immune intervention, but to do so, we must also accept possible severe side effects in an otherwise healthy child,” she said. On the other hand, type 1 diabetes can be treated well. “With pumps and continuous glucose monitoring, insulin therapy in children and adolescents has become significantly safer and more effective,” she said.
New therapeutic options
Whether voluntary screening for type 1 diabetes eventually finds its way into standard care depends on the further development of preventive medications. Dr. Ziegler stressed that future preventive therapy does not need to be limited to the anti-CD3 antibody teplizumab.
For example, strategies such as high-dose oral insulin therapy are being investigated. Verapamil, which is used to treat hypertension, is also promising, since with it, beta cells were retained in early stage 3, and it improved their function. The fusion protein abatacept fell short of statistical significance in a recently published study. For Dr. Ziegler, one thing remains true. “The therapy of type 1 diabetes is about to undergo a renaissance.”
This article was translated from the Medscape German Edition. A version of this article appeared on Medscape.com.
FDA OKs empagliflozin for children with type 2 diabetes
aged 10 years and older.
This approval represents only the second oral treatment option for children and adolescents with type 2 diabetes after metformin; the latter appears to be less effective for pediatric patients than for adults.
Injectable glucagonlike peptide–1 (GLP-1) agonists are also available for youth with type 2 diabetes. These include daily liraglutide (Victoza) and once-weekly extended-release exenatide (Bydureon/Bydureon BCise).
Jardiance has been approved for adults with type 2 diabetes since 2014, and Synjardy has been approved since 2015.
“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH.
“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes,” added Dr. Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research.
Type 2 diabetes rising exponentially in children, mainly non-Whites
Type 2 diabetes is rising exponentially in children and adolescents in the United States.
Data from the SEARCH for Diabetes in Youth study show that the incidence of type 2 diabetes among youth rose by about 5% per year between 2002 and 2015, and it continues to rise.
A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups.
Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial. That trial included 157 patients aged 10-17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were given diet and exercise advice.
At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared with placebo.
Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken.
Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935).
“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” Lori Laffel, MD, lead investigator of the DINAMO study, said in a press release from BI.
“These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth,” added Dr. Laffel, chief of the pediatric, adolescent, and young adult section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston.
A version of this article first appeared on Medscape.com.
aged 10 years and older.
This approval represents only the second oral treatment option for children and adolescents with type 2 diabetes after metformin; the latter appears to be less effective for pediatric patients than for adults.
Injectable glucagonlike peptide–1 (GLP-1) agonists are also available for youth with type 2 diabetes. These include daily liraglutide (Victoza) and once-weekly extended-release exenatide (Bydureon/Bydureon BCise).
Jardiance has been approved for adults with type 2 diabetes since 2014, and Synjardy has been approved since 2015.
“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH.
“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes,” added Dr. Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research.
Type 2 diabetes rising exponentially in children, mainly non-Whites
Type 2 diabetes is rising exponentially in children and adolescents in the United States.
Data from the SEARCH for Diabetes in Youth study show that the incidence of type 2 diabetes among youth rose by about 5% per year between 2002 and 2015, and it continues to rise.
A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups.
Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial. That trial included 157 patients aged 10-17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were given diet and exercise advice.
At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared with placebo.
Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken.
Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935).
“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” Lori Laffel, MD, lead investigator of the DINAMO study, said in a press release from BI.
“These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth,” added Dr. Laffel, chief of the pediatric, adolescent, and young adult section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston.
A version of this article first appeared on Medscape.com.
aged 10 years and older.
This approval represents only the second oral treatment option for children and adolescents with type 2 diabetes after metformin; the latter appears to be less effective for pediatric patients than for adults.
Injectable glucagonlike peptide–1 (GLP-1) agonists are also available for youth with type 2 diabetes. These include daily liraglutide (Victoza) and once-weekly extended-release exenatide (Bydureon/Bydureon BCise).
Jardiance has been approved for adults with type 2 diabetes since 2014, and Synjardy has been approved since 2015.
“Compared to adults, children with type 2 diabetes have limited treatment options, even though the disease and symptom onset generally progress more rapidly in children,” said Michelle Carey, MD, MPH.
“Today’s approvals provide much-needed additional treatment options for children with type 2 diabetes,” added Dr. Carey, associate director for therapeutic review for the division of diabetes, lipid disorders, and obesity in the FDA’s Center for Drug Evaluation and Research.
Type 2 diabetes rising exponentially in children, mainly non-Whites
Type 2 diabetes is rising exponentially in children and adolescents in the United States.
Data from the SEARCH for Diabetes in Youth study show that the incidence of type 2 diabetes among youth rose by about 5% per year between 2002 and 2015, and it continues to rise.
A more recent study found that a doubling of cases occurred during the pandemic, with youth often presenting with more severe disease. The majority of cases are among non-White racial groups.
Safety and efficacy data for empagliflozin for children came from the Diabetes Study of Linagliptin and Empagliflozin in Children and Adolescents (DINAMO) trial. That trial included 157 patients aged 10-17 years with A1c of 7% or above. Patients were randomly assigned to receive empagliflozin 10 mg or 25 mg daily, linagliptin (a DPP-4 inhibitor) 5 mg, or placebo for 26 weeks. Over 90% were also taking metformin, 40% in combination with insulin. All patients were given diet and exercise advice.
At week 26, the children treated with empagliflozin showed an average 0.2 percentage point decrease in A1c, compared with a 0.7-point increase among those taking placebo. Use of empagliflozin was also associated with lower fasting plasma glucose levels compared with placebo.
Side effects were similar to those seen in adults except for a higher risk of hypoglycemia, regardless of other glucose-lowering therapies that were being taken.
Reduction in A1c for participants treated with linagliptin was not statistically significant in comparison with placebo. There was a numerical reduction of 0.34% (P = .2935).
“Across the lifespan, we know that people living with type 2 diabetes have a high risk for many diabetes complications, so it’s important to recognize and treat diabetes early in its course,” Lori Laffel, MD, lead investigator of the DINAMO study, said in a press release from BI.
“These findings are particularly important given the need for more therapeutic options, especially oral agents, to manage type 2 diabetes in young people as, to date, metformin [has been] the only globally available oral treatment for youth,” added Dr. Laffel, chief of the pediatric, adolescent, and young adult section at the Joslin Diabetes Center and professor of pediatrics at Harvard Medical School, Boston.
A version of this article first appeared on Medscape.com.
Warts difficult to eradicate in immunocompromised children
.
Only a quarter of patients (24%) who were undergoing active cancer treatment experienced complete resolution of their warts, compared with 63.3% of patients who were not on active treatment.
In addition, warts persisted or worsened in 56.0% of patients receiving active treatment compared with 13.4% of those who were not receiving it.
“These data enable providers treating warts in children with cancer to have an educated discussion regarding the expected clinical progression of warts and the likelihood of response to wart therapy while on and off anti-cancer treatment,” the authors wrote in the study, published in Pediatric Dermatology.
In immunocompromised children, warts are more common than in the general pediatric population, and more resistant to treatment. But as the authors noted, data on the course and prognosis of warts in pediatric patients who are actively receiving anti-cancer therapy compared with patients who have completed treatment are limited.
Tina Ho, MD, PhD, of the department of dermatology, and colleagues from Boston Children’s Hospital, sought to analyze the clinical course of warts treated in this patient population at their institution over a 10-year period. They conducted a retrospective study of 72 children who were treated for cancer between 2011 and 2021, and who had also been treated for warts.
The median age of the cohort was 12 years, and they were followed for a median of 2 years following their diagnosis of warts. Within this group, more than half (55%) had hematologic malignancies, while 27% had a history of bone marrow transplantation.
Of note, the authors pointed out, 54% of the patients had plantar warts, and 60% of patients (38 of 63) with a documented number of warts had more than five at the time of presentation.
The treatment regimens that the children had received varied, with 81% of patients receiving cytotoxic chemotherapy and 23% of patients on targeted therapies that included immunotherapy.
The warts were most commonly treated with cryotherapy and topical salicylic acid; this was the case for those actively receiving oncology treatment or those who had completed their treatment regimens.
Outcomes of wart treatments were available in 25 of the patients undergoing active cancer treatment and in 30 of those who had completed treatment. For children on active oncology treatment, 5 (20%) achieved partial resolution, 6 (24%) achieved complete resolution, and 14 (56%) experienced persistence or worsening of their warts following therapy. Those who had completed treatment had better outcomes: Seven (23.3%) had a partial response, 19 (63.3%) had complete resolution, and 4 (13.4%) had persistence or worsening of warts after treatment of warts.
The authors also pointed out the treatment of warts can be painful, expensive, and time-consuming. “It is thus imperative that the risks and benefits of these treatments are carefully considered before proceeding with treatment,” wrote Dr. Ho and colleagues. “This is especially true in medically complex children with cancer who may be fearful of procedures and spend significant portions of their young lives within the medical system.”
Limitations to the study include its retrospective design and small sample size. Clinical data were not uniformly complete, and follow-up intervals varied among the participants. Also, it was conducted at a single-institution and at a large tertiary center, so the results may not be fully generalizable.
The authors declared no conflict of interest. No outside funding source was listed.
.
Only a quarter of patients (24%) who were undergoing active cancer treatment experienced complete resolution of their warts, compared with 63.3% of patients who were not on active treatment.
In addition, warts persisted or worsened in 56.0% of patients receiving active treatment compared with 13.4% of those who were not receiving it.
“These data enable providers treating warts in children with cancer to have an educated discussion regarding the expected clinical progression of warts and the likelihood of response to wart therapy while on and off anti-cancer treatment,” the authors wrote in the study, published in Pediatric Dermatology.
In immunocompromised children, warts are more common than in the general pediatric population, and more resistant to treatment. But as the authors noted, data on the course and prognosis of warts in pediatric patients who are actively receiving anti-cancer therapy compared with patients who have completed treatment are limited.
Tina Ho, MD, PhD, of the department of dermatology, and colleagues from Boston Children’s Hospital, sought to analyze the clinical course of warts treated in this patient population at their institution over a 10-year period. They conducted a retrospective study of 72 children who were treated for cancer between 2011 and 2021, and who had also been treated for warts.
The median age of the cohort was 12 years, and they were followed for a median of 2 years following their diagnosis of warts. Within this group, more than half (55%) had hematologic malignancies, while 27% had a history of bone marrow transplantation.
Of note, the authors pointed out, 54% of the patients had plantar warts, and 60% of patients (38 of 63) with a documented number of warts had more than five at the time of presentation.
The treatment regimens that the children had received varied, with 81% of patients receiving cytotoxic chemotherapy and 23% of patients on targeted therapies that included immunotherapy.
The warts were most commonly treated with cryotherapy and topical salicylic acid; this was the case for those actively receiving oncology treatment or those who had completed their treatment regimens.
Outcomes of wart treatments were available in 25 of the patients undergoing active cancer treatment and in 30 of those who had completed treatment. For children on active oncology treatment, 5 (20%) achieved partial resolution, 6 (24%) achieved complete resolution, and 14 (56%) experienced persistence or worsening of their warts following therapy. Those who had completed treatment had better outcomes: Seven (23.3%) had a partial response, 19 (63.3%) had complete resolution, and 4 (13.4%) had persistence or worsening of warts after treatment of warts.
The authors also pointed out the treatment of warts can be painful, expensive, and time-consuming. “It is thus imperative that the risks and benefits of these treatments are carefully considered before proceeding with treatment,” wrote Dr. Ho and colleagues. “This is especially true in medically complex children with cancer who may be fearful of procedures and spend significant portions of their young lives within the medical system.”
Limitations to the study include its retrospective design and small sample size. Clinical data were not uniformly complete, and follow-up intervals varied among the participants. Also, it was conducted at a single-institution and at a large tertiary center, so the results may not be fully generalizable.
The authors declared no conflict of interest. No outside funding source was listed.
.
Only a quarter of patients (24%) who were undergoing active cancer treatment experienced complete resolution of their warts, compared with 63.3% of patients who were not on active treatment.
In addition, warts persisted or worsened in 56.0% of patients receiving active treatment compared with 13.4% of those who were not receiving it.
“These data enable providers treating warts in children with cancer to have an educated discussion regarding the expected clinical progression of warts and the likelihood of response to wart therapy while on and off anti-cancer treatment,” the authors wrote in the study, published in Pediatric Dermatology.
In immunocompromised children, warts are more common than in the general pediatric population, and more resistant to treatment. But as the authors noted, data on the course and prognosis of warts in pediatric patients who are actively receiving anti-cancer therapy compared with patients who have completed treatment are limited.
Tina Ho, MD, PhD, of the department of dermatology, and colleagues from Boston Children’s Hospital, sought to analyze the clinical course of warts treated in this patient population at their institution over a 10-year period. They conducted a retrospective study of 72 children who were treated for cancer between 2011 and 2021, and who had also been treated for warts.
The median age of the cohort was 12 years, and they were followed for a median of 2 years following their diagnosis of warts. Within this group, more than half (55%) had hematologic malignancies, while 27% had a history of bone marrow transplantation.
Of note, the authors pointed out, 54% of the patients had plantar warts, and 60% of patients (38 of 63) with a documented number of warts had more than five at the time of presentation.
The treatment regimens that the children had received varied, with 81% of patients receiving cytotoxic chemotherapy and 23% of patients on targeted therapies that included immunotherapy.
The warts were most commonly treated with cryotherapy and topical salicylic acid; this was the case for those actively receiving oncology treatment or those who had completed their treatment regimens.
Outcomes of wart treatments were available in 25 of the patients undergoing active cancer treatment and in 30 of those who had completed treatment. For children on active oncology treatment, 5 (20%) achieved partial resolution, 6 (24%) achieved complete resolution, and 14 (56%) experienced persistence or worsening of their warts following therapy. Those who had completed treatment had better outcomes: Seven (23.3%) had a partial response, 19 (63.3%) had complete resolution, and 4 (13.4%) had persistence or worsening of warts after treatment of warts.
The authors also pointed out the treatment of warts can be painful, expensive, and time-consuming. “It is thus imperative that the risks and benefits of these treatments are carefully considered before proceeding with treatment,” wrote Dr. Ho and colleagues. “This is especially true in medically complex children with cancer who may be fearful of procedures and spend significant portions of their young lives within the medical system.”
Limitations to the study include its retrospective design and small sample size. Clinical data were not uniformly complete, and follow-up intervals varied among the participants. Also, it was conducted at a single-institution and at a large tertiary center, so the results may not be fully generalizable.
The authors declared no conflict of interest. No outside funding source was listed.
FROM PEDIATRIC DERMATOLOGY
Father’s influence impacts whether their infant is breastfed, follows safe sleeping practices
Infants of fathers who want their child to breastfeed are more likely to be part of a family unit that starts and continues breastfeeding, and fathers informed of safe sleep practices are more likely to follow those sleeping recommendations for their infant, according to the results of a recent survey published in Pediatrics.
The results suggest that the researchers said.
“Our findings underscore that new fathers are a critical audience to promote breastfeeding and safe infant sleep,” John James Parker, MD, instructor of pediatrics at Northwestern University, Chicago, stated in a press release. “Many families do not gain the health benefits from breastfeeding because they are not provided the support to breastfeed successfully. Fathers need to be directly engaged in breastfeeding discussions, and providers need to describe the important role fathers play in breastfeeding success.”
Population-based survey results
Dr. Parker and colleagues used the Pregnancy Risk Assessment Monitoring System (PRAMS) for Dads population-based survey to evaluate the rate of adherence to breastfeeding and infant sleep practices recommended by the American Academy of Pediatrics. In total, 250 fathers in Georgia were surveyed between October 2018 and July 2019 about whether their infants were breastfeeding and if they were breastfeeding at 8 weeks. The fathers were also asked how often the infant slept in a back sleeping position, on an approved sleep surface, and sleeping with no soft objects or soft bedding.
In addition to surveying fathers on their attitudes on breastfeeding and whether they followed safe infant sleep practices, the researchers collected information on paternal sociodemographic characteristics such as age, race and ethnicity, education, health insurance status, and marital status. Overall, a majority fathers who responded to the survey were between 25 years and 34 years old (56.5%), non-Hispanic White (44.7%), had a high school diploma or less (43.7%) or completed college (37.1%), and were married (65.2%).
Dr. Parker and colleagues found fathers surveyed said 86.1% of infants were ever breastfed, which decreased to 63.4% at 8 weeks. Compared with fathers who did not want their infant to breastfeed or expressed no opinion, fathers who wanted to have the infant’s mother breastfeed had a higher likelihood of reporting breastfeeding initiation (adjusted prevalence ratio, 1.39; 95% confidence interval, 1.15-1.68) and breastfeeding at 8 weeks (aPR, 2.33; 95% CI, 1.59-3.42). Having a college degree was also associated with the infant breastfeeding (93.6% vs. 75.1%; aPR, 1.25; 95% CI, 1.06-1.46) and breastfeeding at 8 weeks (74.7% vs. 52.0%; aPR, 1.44; 95% CI, 1.08-1.91), compared with fathers who graduated from high school or less.
Regarding safe infant sleeping practices, 81.18% of fathers said they placed their infants on their back to sleep, but 44.1% said they did not use soft bedding, and 31.9% said they used an approved sleep surface. In total, 99.4% of fathers put their infant to sleep, and 68.4% said they received information on all three infant safe sleeping practices, while 15.7% said they followed all three sleeping recommendations. A health care provider was the most common person giving advice to the father on placing the infant to sleep on their back (84.7%); to use a safe sleep surface such as a crib, bassinet, or pack-and-play (78.7%); and receiving information about what not to place in the infant’s bed (79.1%).
The survey found non-Hispanic Black fathers reported they were less likely to put the infant to sleep on their back (62.5% vs. 89.5%; aPR, 0.70; 95% CI, 0.54-0.90) and not use soft bedding (28.1% vs. 54.1%; aPR, 0.52; 95% CI, 0.30-0.89), compared with non-Hispanic White fathers. College graduates were more likely to not use soft bedding (61.4% vs. 31.9%; aPR, 1.92; 95% CI, 1.25-2.95), more likely to get advice on placing the infant on their back for sleep (94.3% vs. 73.6%; aPR, 1.28; 95% CI, 1.09-1.51), and more likely to receive advice on what not to place in the infant’s bed (88.1% vs. 68.5%; aPR, 1.29; 95% CI, 1.06-1.57), compared with fathers with a high school diploma or less.
“Fathers need to receive counseling on all the safe sleep practices for their infants,” Dr. Parker said. “To reduce racial disparities in sudden unexpected infant death, we need tailored strategies to increase safe infant sleep practices in the Black community, including public campaigns to increase awareness and home visiting programs. These interventions must involve both parents to be most effective.”
Educational efforts should recognize father’s contributions
In an interview, Deborah E. Campbell, MD, chief of neonatology at the Children’s Hospital at Montefiore, New York, said the survey “adds further important information on the role of fathers both in the care of their infants and young children, but also in terms of supporting the birth parent and a number of the parenting decisions, whether it’s breastfeeding as well as safe sleep practices for the infant.”
The benefits of breastfeeding are important for the infant but also for the health of the family and the community, Dr. Campbell explained, noting that breastfeeding can aid in preventing chronic disease and cancer. Promoting safe sleep practices for infants, on the other hand, helps reduce factors such as infant mortality and sudden unexpected infant death.
While PRAMS has existed for decades, PRAMS for Dads is relatively new and localized as a pilot program in Georgia, Dr. Campbell noted. The pilot program “really shows that you can get helpful information, and it would be wonderful to see that model expanded to begin to look at the father’s role in other states as well.”
To improve adherence to breastfeeding and infant safe sleeping practices, creating broadly educational efforts that include and recognize the contributions of the father are important, especially as fathers today are generally more involved and engaged than in past generations, Dr. Campbell said. For instance, pediatric or family practice offices could be structured in a way that welcomes fathers and appreciates them, rather than focusing solely on the birth mother or the baby.
“I think certainly as we have greater diversity among our families, greater diversity within our communities, just more varied family constellations, recognizing and valuing each member of the family becomes important and then providing them with the information and the tools,” she said.
While health literacy is important, structural inequalities in care provision in health care settings mean that “it’s honestly much more likely that an educated parent is going to have an opportunity to hear more of those messages,” Dr. Campbell said. “They are much more likely to be able to go to childbirth classes, go to the pediatrician visits, take off from work, have leaves so that they can spend time in the hospital during the infant’s stay and the birth parent’s initial recoveries so that they have greater opportunity to get those messages.”
Fathers with lower educational attainment may have good health literacy, but may be unable to be around for these conversations. “Education is really a proxy for a lot of other structural issues,” she said.
Educational messages around safe sleeping practices for the infant should acknowledge that many families might not have the space to have a dedicated room with a crib for an infant, and offer assurances that other safe sleeping options exist, such as a pack-and-play or Moses basket. The most important message to get across to parents is that the baby is “sleeping alone” in a firm, noninclined surface and does not have bedding or other objects around them.
It is not just the infant’s bed that should follow the AAP recommendations: the family bed should also be a firm surface free of soft objects and bedding for breastfeeding, Dr. Campbell noted. If a parent falls asleep while breastfeeding in bed, the AAP’s most recent guidance notes the parent should move the infant to a separate sleep space as soon as they wake up, but the Academy also acknowledges how that can be challenging in early months with sleep deprivation.
“I think it’s dealing with the realities of having a new baby and trying to create the safest environment for that baby, one that supports and promotes breastfeeding as well as safe sleep,” she said.
In families where there are “strong cultural beliefs and traditions” about the baby sleeping with the parents, it is important to “convey the messages in a way that, that honors and values, family traditions and customs, but also assures the safety of the infant,” Dr. Campbell said.
This study was supported by the Centers for Disease Control and Prevention and CDC Innovation Fund. The authors reported no relevant conflicts of interest. Dr. Campbell reported no relevant conflicts of interest.
Infants of fathers who want their child to breastfeed are more likely to be part of a family unit that starts and continues breastfeeding, and fathers informed of safe sleep practices are more likely to follow those sleeping recommendations for their infant, according to the results of a recent survey published in Pediatrics.
The results suggest that the researchers said.
“Our findings underscore that new fathers are a critical audience to promote breastfeeding and safe infant sleep,” John James Parker, MD, instructor of pediatrics at Northwestern University, Chicago, stated in a press release. “Many families do not gain the health benefits from breastfeeding because they are not provided the support to breastfeed successfully. Fathers need to be directly engaged in breastfeeding discussions, and providers need to describe the important role fathers play in breastfeeding success.”
Population-based survey results
Dr. Parker and colleagues used the Pregnancy Risk Assessment Monitoring System (PRAMS) for Dads population-based survey to evaluate the rate of adherence to breastfeeding and infant sleep practices recommended by the American Academy of Pediatrics. In total, 250 fathers in Georgia were surveyed between October 2018 and July 2019 about whether their infants were breastfeeding and if they were breastfeeding at 8 weeks. The fathers were also asked how often the infant slept in a back sleeping position, on an approved sleep surface, and sleeping with no soft objects or soft bedding.
In addition to surveying fathers on their attitudes on breastfeeding and whether they followed safe infant sleep practices, the researchers collected information on paternal sociodemographic characteristics such as age, race and ethnicity, education, health insurance status, and marital status. Overall, a majority fathers who responded to the survey were between 25 years and 34 years old (56.5%), non-Hispanic White (44.7%), had a high school diploma or less (43.7%) or completed college (37.1%), and were married (65.2%).
Dr. Parker and colleagues found fathers surveyed said 86.1% of infants were ever breastfed, which decreased to 63.4% at 8 weeks. Compared with fathers who did not want their infant to breastfeed or expressed no opinion, fathers who wanted to have the infant’s mother breastfeed had a higher likelihood of reporting breastfeeding initiation (adjusted prevalence ratio, 1.39; 95% confidence interval, 1.15-1.68) and breastfeeding at 8 weeks (aPR, 2.33; 95% CI, 1.59-3.42). Having a college degree was also associated with the infant breastfeeding (93.6% vs. 75.1%; aPR, 1.25; 95% CI, 1.06-1.46) and breastfeeding at 8 weeks (74.7% vs. 52.0%; aPR, 1.44; 95% CI, 1.08-1.91), compared with fathers who graduated from high school or less.
Regarding safe infant sleeping practices, 81.18% of fathers said they placed their infants on their back to sleep, but 44.1% said they did not use soft bedding, and 31.9% said they used an approved sleep surface. In total, 99.4% of fathers put their infant to sleep, and 68.4% said they received information on all three infant safe sleeping practices, while 15.7% said they followed all three sleeping recommendations. A health care provider was the most common person giving advice to the father on placing the infant to sleep on their back (84.7%); to use a safe sleep surface such as a crib, bassinet, or pack-and-play (78.7%); and receiving information about what not to place in the infant’s bed (79.1%).
The survey found non-Hispanic Black fathers reported they were less likely to put the infant to sleep on their back (62.5% vs. 89.5%; aPR, 0.70; 95% CI, 0.54-0.90) and not use soft bedding (28.1% vs. 54.1%; aPR, 0.52; 95% CI, 0.30-0.89), compared with non-Hispanic White fathers. College graduates were more likely to not use soft bedding (61.4% vs. 31.9%; aPR, 1.92; 95% CI, 1.25-2.95), more likely to get advice on placing the infant on their back for sleep (94.3% vs. 73.6%; aPR, 1.28; 95% CI, 1.09-1.51), and more likely to receive advice on what not to place in the infant’s bed (88.1% vs. 68.5%; aPR, 1.29; 95% CI, 1.06-1.57), compared with fathers with a high school diploma or less.
“Fathers need to receive counseling on all the safe sleep practices for their infants,” Dr. Parker said. “To reduce racial disparities in sudden unexpected infant death, we need tailored strategies to increase safe infant sleep practices in the Black community, including public campaigns to increase awareness and home visiting programs. These interventions must involve both parents to be most effective.”
Educational efforts should recognize father’s contributions
In an interview, Deborah E. Campbell, MD, chief of neonatology at the Children’s Hospital at Montefiore, New York, said the survey “adds further important information on the role of fathers both in the care of their infants and young children, but also in terms of supporting the birth parent and a number of the parenting decisions, whether it’s breastfeeding as well as safe sleep practices for the infant.”
The benefits of breastfeeding are important for the infant but also for the health of the family and the community, Dr. Campbell explained, noting that breastfeeding can aid in preventing chronic disease and cancer. Promoting safe sleep practices for infants, on the other hand, helps reduce factors such as infant mortality and sudden unexpected infant death.
While PRAMS has existed for decades, PRAMS for Dads is relatively new and localized as a pilot program in Georgia, Dr. Campbell noted. The pilot program “really shows that you can get helpful information, and it would be wonderful to see that model expanded to begin to look at the father’s role in other states as well.”
To improve adherence to breastfeeding and infant safe sleeping practices, creating broadly educational efforts that include and recognize the contributions of the father are important, especially as fathers today are generally more involved and engaged than in past generations, Dr. Campbell said. For instance, pediatric or family practice offices could be structured in a way that welcomes fathers and appreciates them, rather than focusing solely on the birth mother or the baby.
“I think certainly as we have greater diversity among our families, greater diversity within our communities, just more varied family constellations, recognizing and valuing each member of the family becomes important and then providing them with the information and the tools,” she said.
While health literacy is important, structural inequalities in care provision in health care settings mean that “it’s honestly much more likely that an educated parent is going to have an opportunity to hear more of those messages,” Dr. Campbell said. “They are much more likely to be able to go to childbirth classes, go to the pediatrician visits, take off from work, have leaves so that they can spend time in the hospital during the infant’s stay and the birth parent’s initial recoveries so that they have greater opportunity to get those messages.”
Fathers with lower educational attainment may have good health literacy, but may be unable to be around for these conversations. “Education is really a proxy for a lot of other structural issues,” she said.
Educational messages around safe sleeping practices for the infant should acknowledge that many families might not have the space to have a dedicated room with a crib for an infant, and offer assurances that other safe sleeping options exist, such as a pack-and-play or Moses basket. The most important message to get across to parents is that the baby is “sleeping alone” in a firm, noninclined surface and does not have bedding or other objects around them.
It is not just the infant’s bed that should follow the AAP recommendations: the family bed should also be a firm surface free of soft objects and bedding for breastfeeding, Dr. Campbell noted. If a parent falls asleep while breastfeeding in bed, the AAP’s most recent guidance notes the parent should move the infant to a separate sleep space as soon as they wake up, but the Academy also acknowledges how that can be challenging in early months with sleep deprivation.
“I think it’s dealing with the realities of having a new baby and trying to create the safest environment for that baby, one that supports and promotes breastfeeding as well as safe sleep,” she said.
In families where there are “strong cultural beliefs and traditions” about the baby sleeping with the parents, it is important to “convey the messages in a way that, that honors and values, family traditions and customs, but also assures the safety of the infant,” Dr. Campbell said.
This study was supported by the Centers for Disease Control and Prevention and CDC Innovation Fund. The authors reported no relevant conflicts of interest. Dr. Campbell reported no relevant conflicts of interest.
Infants of fathers who want their child to breastfeed are more likely to be part of a family unit that starts and continues breastfeeding, and fathers informed of safe sleep practices are more likely to follow those sleeping recommendations for their infant, according to the results of a recent survey published in Pediatrics.
The results suggest that the researchers said.
“Our findings underscore that new fathers are a critical audience to promote breastfeeding and safe infant sleep,” John James Parker, MD, instructor of pediatrics at Northwestern University, Chicago, stated in a press release. “Many families do not gain the health benefits from breastfeeding because they are not provided the support to breastfeed successfully. Fathers need to be directly engaged in breastfeeding discussions, and providers need to describe the important role fathers play in breastfeeding success.”
Population-based survey results
Dr. Parker and colleagues used the Pregnancy Risk Assessment Monitoring System (PRAMS) for Dads population-based survey to evaluate the rate of adherence to breastfeeding and infant sleep practices recommended by the American Academy of Pediatrics. In total, 250 fathers in Georgia were surveyed between October 2018 and July 2019 about whether their infants were breastfeeding and if they were breastfeeding at 8 weeks. The fathers were also asked how often the infant slept in a back sleeping position, on an approved sleep surface, and sleeping with no soft objects or soft bedding.
In addition to surveying fathers on their attitudes on breastfeeding and whether they followed safe infant sleep practices, the researchers collected information on paternal sociodemographic characteristics such as age, race and ethnicity, education, health insurance status, and marital status. Overall, a majority fathers who responded to the survey were between 25 years and 34 years old (56.5%), non-Hispanic White (44.7%), had a high school diploma or less (43.7%) or completed college (37.1%), and were married (65.2%).
Dr. Parker and colleagues found fathers surveyed said 86.1% of infants were ever breastfed, which decreased to 63.4% at 8 weeks. Compared with fathers who did not want their infant to breastfeed or expressed no opinion, fathers who wanted to have the infant’s mother breastfeed had a higher likelihood of reporting breastfeeding initiation (adjusted prevalence ratio, 1.39; 95% confidence interval, 1.15-1.68) and breastfeeding at 8 weeks (aPR, 2.33; 95% CI, 1.59-3.42). Having a college degree was also associated with the infant breastfeeding (93.6% vs. 75.1%; aPR, 1.25; 95% CI, 1.06-1.46) and breastfeeding at 8 weeks (74.7% vs. 52.0%; aPR, 1.44; 95% CI, 1.08-1.91), compared with fathers who graduated from high school or less.
Regarding safe infant sleeping practices, 81.18% of fathers said they placed their infants on their back to sleep, but 44.1% said they did not use soft bedding, and 31.9% said they used an approved sleep surface. In total, 99.4% of fathers put their infant to sleep, and 68.4% said they received information on all three infant safe sleeping practices, while 15.7% said they followed all three sleeping recommendations. A health care provider was the most common person giving advice to the father on placing the infant to sleep on their back (84.7%); to use a safe sleep surface such as a crib, bassinet, or pack-and-play (78.7%); and receiving information about what not to place in the infant’s bed (79.1%).
The survey found non-Hispanic Black fathers reported they were less likely to put the infant to sleep on their back (62.5% vs. 89.5%; aPR, 0.70; 95% CI, 0.54-0.90) and not use soft bedding (28.1% vs. 54.1%; aPR, 0.52; 95% CI, 0.30-0.89), compared with non-Hispanic White fathers. College graduates were more likely to not use soft bedding (61.4% vs. 31.9%; aPR, 1.92; 95% CI, 1.25-2.95), more likely to get advice on placing the infant on their back for sleep (94.3% vs. 73.6%; aPR, 1.28; 95% CI, 1.09-1.51), and more likely to receive advice on what not to place in the infant’s bed (88.1% vs. 68.5%; aPR, 1.29; 95% CI, 1.06-1.57), compared with fathers with a high school diploma or less.
“Fathers need to receive counseling on all the safe sleep practices for their infants,” Dr. Parker said. “To reduce racial disparities in sudden unexpected infant death, we need tailored strategies to increase safe infant sleep practices in the Black community, including public campaigns to increase awareness and home visiting programs. These interventions must involve both parents to be most effective.”
Educational efforts should recognize father’s contributions
In an interview, Deborah E. Campbell, MD, chief of neonatology at the Children’s Hospital at Montefiore, New York, said the survey “adds further important information on the role of fathers both in the care of their infants and young children, but also in terms of supporting the birth parent and a number of the parenting decisions, whether it’s breastfeeding as well as safe sleep practices for the infant.”
The benefits of breastfeeding are important for the infant but also for the health of the family and the community, Dr. Campbell explained, noting that breastfeeding can aid in preventing chronic disease and cancer. Promoting safe sleep practices for infants, on the other hand, helps reduce factors such as infant mortality and sudden unexpected infant death.
While PRAMS has existed for decades, PRAMS for Dads is relatively new and localized as a pilot program in Georgia, Dr. Campbell noted. The pilot program “really shows that you can get helpful information, and it would be wonderful to see that model expanded to begin to look at the father’s role in other states as well.”
To improve adherence to breastfeeding and infant safe sleeping practices, creating broadly educational efforts that include and recognize the contributions of the father are important, especially as fathers today are generally more involved and engaged than in past generations, Dr. Campbell said. For instance, pediatric or family practice offices could be structured in a way that welcomes fathers and appreciates them, rather than focusing solely on the birth mother or the baby.
“I think certainly as we have greater diversity among our families, greater diversity within our communities, just more varied family constellations, recognizing and valuing each member of the family becomes important and then providing them with the information and the tools,” she said.
While health literacy is important, structural inequalities in care provision in health care settings mean that “it’s honestly much more likely that an educated parent is going to have an opportunity to hear more of those messages,” Dr. Campbell said. “They are much more likely to be able to go to childbirth classes, go to the pediatrician visits, take off from work, have leaves so that they can spend time in the hospital during the infant’s stay and the birth parent’s initial recoveries so that they have greater opportunity to get those messages.”
Fathers with lower educational attainment may have good health literacy, but may be unable to be around for these conversations. “Education is really a proxy for a lot of other structural issues,” she said.
Educational messages around safe sleeping practices for the infant should acknowledge that many families might not have the space to have a dedicated room with a crib for an infant, and offer assurances that other safe sleeping options exist, such as a pack-and-play or Moses basket. The most important message to get across to parents is that the baby is “sleeping alone” in a firm, noninclined surface and does not have bedding or other objects around them.
It is not just the infant’s bed that should follow the AAP recommendations: the family bed should also be a firm surface free of soft objects and bedding for breastfeeding, Dr. Campbell noted. If a parent falls asleep while breastfeeding in bed, the AAP’s most recent guidance notes the parent should move the infant to a separate sleep space as soon as they wake up, but the Academy also acknowledges how that can be challenging in early months with sleep deprivation.
“I think it’s dealing with the realities of having a new baby and trying to create the safest environment for that baby, one that supports and promotes breastfeeding as well as safe sleep,” she said.
In families where there are “strong cultural beliefs and traditions” about the baby sleeping with the parents, it is important to “convey the messages in a way that, that honors and values, family traditions and customs, but also assures the safety of the infant,” Dr. Campbell said.
This study was supported by the Centers for Disease Control and Prevention and CDC Innovation Fund. The authors reported no relevant conflicts of interest. Dr. Campbell reported no relevant conflicts of interest.
FROM PEDIATRICS
Bordetella parapertussis reemerges as a cause of respiratory illness in children
A 4-year-old male presented to an urgent care center with a 2-week history of runny nose and cough. The treating clinician suspected a postviral cough, but the child’s mother was unconvinced. Testing for SARS-CoV-2, influenza, and respiratory syncytial virus performed earlier in the week at the pediatrician’s office was negative. At the mother’s insistence, an expanded respiratory panel was ordered and revealed a surprising result: Bordetella parapertussis.
Just like B. pertussis, B. parapertussis can cause a prolonged cough illness characterized by coughing paroxysms, whoop, and posttussive emesis. Testing is the only way to reliably distinguish between the two infections. In general, disease due to B. parapertussis tends to be milder than typical pertussis and symptoms usually don’t last as long. In one study, 40% of people with B. parapertussis had no symptoms. B. parapertussis does not produce pertussis toxin and this may affect disease severity. Rarely, children can be coinfected with both B. pertussis and B. parapertussis.
The burden of B. parapertussis in the United States is not well described because only pertussis cases caused by B. pertussis are reportable to the Centers for Disease Control and Prevention. Nevertheless, some states include cases in public reporting and outbreaks have been reported. Historically, disease has been cyclical, with peaks in cases every 4 years and no seasonality.
This year, some communities are currently seeing an increase in B. parapertussis cases. Through June 11 of this year, 40 cases of B. parapertussis and no cases of B. pertussis have been identified at Norton Healthcare in Louisville, Ky. For comparison, one case of B. parapertussis was reported in 2022 and no cases were reported in 2021. Chatter on infectious diseases listservs suggests that clinicians in other communities are also seeing an increase in cases.
According to Andi Shane, MD, MPH, chief of the division of pediatric infectious diseases at Emory University and Children’s Healthcare of Atlanta, an unusually high number of children with B. parapertussis were identified in the Atlanta area this spring. “Fortunately, most children had mild illness and of these, only a few required admission to the hospital,” Dr. Shane said.
Back at the urgent care center, the clinician on duty called the patient’s mom to discuss the diagnosis of B. parapertussis. By the time the test result was available, the patient was asymptomatic. The clinician advised that antibiotic therapy was not indicated.
Treatment recommendations diverge for B. pertussis and B. parapertussis and this is a point of emphasis for clinicians. Treatment of B. pertussis during the catarrhal phase may ameliorate disease. Treatment initiated after the catarrhal phase has little impact on symptoms but may reduce spread to others. In most cases, treatment isn’t recommended for B. parapertussis. It is not clear how well antibiotics work against this organism. Macrolides such as erythromycin and azithromycin that are used to treat pertussis may have some activity, along with trimethoprim-sulfamethoxazole and ciprofloxacin. According to the American Academy of Pediatrics, treatment is usually reserved for individuals at risk for more severe disease, including infants, especially those less than 6 months of age, the elderly, and immunocompromised persons. Prophylactic antibiotic therapy is not recommended for most persons exposed to B. parapertussis, although some public health experts also recommend treatment of B. parapertussis-infected people in contact with young infants and others are risk for severe disease.
In recent epidemiologic reports, patients with B. parapertussis infection had received age-appropriate vaccination for pertussis, suggesting that available pertussis vaccines offer little to no protection against this disease. The best prevention strategies are similar to those that are effective against other illness spread by respiratory droplets. Sick people should stay at home and cover their coughs when around others. Everyone should practice good hand hygiene.
Are you seeing increased cases of B. parapertussis in your community? Email me at [email protected].
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta and Gilead. Email her at [email protected].
A 4-year-old male presented to an urgent care center with a 2-week history of runny nose and cough. The treating clinician suspected a postviral cough, but the child’s mother was unconvinced. Testing for SARS-CoV-2, influenza, and respiratory syncytial virus performed earlier in the week at the pediatrician’s office was negative. At the mother’s insistence, an expanded respiratory panel was ordered and revealed a surprising result: Bordetella parapertussis.
Just like B. pertussis, B. parapertussis can cause a prolonged cough illness characterized by coughing paroxysms, whoop, and posttussive emesis. Testing is the only way to reliably distinguish between the two infections. In general, disease due to B. parapertussis tends to be milder than typical pertussis and symptoms usually don’t last as long. In one study, 40% of people with B. parapertussis had no symptoms. B. parapertussis does not produce pertussis toxin and this may affect disease severity. Rarely, children can be coinfected with both B. pertussis and B. parapertussis.
The burden of B. parapertussis in the United States is not well described because only pertussis cases caused by B. pertussis are reportable to the Centers for Disease Control and Prevention. Nevertheless, some states include cases in public reporting and outbreaks have been reported. Historically, disease has been cyclical, with peaks in cases every 4 years and no seasonality.
This year, some communities are currently seeing an increase in B. parapertussis cases. Through June 11 of this year, 40 cases of B. parapertussis and no cases of B. pertussis have been identified at Norton Healthcare in Louisville, Ky. For comparison, one case of B. parapertussis was reported in 2022 and no cases were reported in 2021. Chatter on infectious diseases listservs suggests that clinicians in other communities are also seeing an increase in cases.
According to Andi Shane, MD, MPH, chief of the division of pediatric infectious diseases at Emory University and Children’s Healthcare of Atlanta, an unusually high number of children with B. parapertussis were identified in the Atlanta area this spring. “Fortunately, most children had mild illness and of these, only a few required admission to the hospital,” Dr. Shane said.
Back at the urgent care center, the clinician on duty called the patient’s mom to discuss the diagnosis of B. parapertussis. By the time the test result was available, the patient was asymptomatic. The clinician advised that antibiotic therapy was not indicated.
Treatment recommendations diverge for B. pertussis and B. parapertussis and this is a point of emphasis for clinicians. Treatment of B. pertussis during the catarrhal phase may ameliorate disease. Treatment initiated after the catarrhal phase has little impact on symptoms but may reduce spread to others. In most cases, treatment isn’t recommended for B. parapertussis. It is not clear how well antibiotics work against this organism. Macrolides such as erythromycin and azithromycin that are used to treat pertussis may have some activity, along with trimethoprim-sulfamethoxazole and ciprofloxacin. According to the American Academy of Pediatrics, treatment is usually reserved for individuals at risk for more severe disease, including infants, especially those less than 6 months of age, the elderly, and immunocompromised persons. Prophylactic antibiotic therapy is not recommended for most persons exposed to B. parapertussis, although some public health experts also recommend treatment of B. parapertussis-infected people in contact with young infants and others are risk for severe disease.
In recent epidemiologic reports, patients with B. parapertussis infection had received age-appropriate vaccination for pertussis, suggesting that available pertussis vaccines offer little to no protection against this disease. The best prevention strategies are similar to those that are effective against other illness spread by respiratory droplets. Sick people should stay at home and cover their coughs when around others. Everyone should practice good hand hygiene.
Are you seeing increased cases of B. parapertussis in your community? Email me at [email protected].
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta and Gilead. Email her at [email protected].
A 4-year-old male presented to an urgent care center with a 2-week history of runny nose and cough. The treating clinician suspected a postviral cough, but the child’s mother was unconvinced. Testing for SARS-CoV-2, influenza, and respiratory syncytial virus performed earlier in the week at the pediatrician’s office was negative. At the mother’s insistence, an expanded respiratory panel was ordered and revealed a surprising result: Bordetella parapertussis.
Just like B. pertussis, B. parapertussis can cause a prolonged cough illness characterized by coughing paroxysms, whoop, and posttussive emesis. Testing is the only way to reliably distinguish between the two infections. In general, disease due to B. parapertussis tends to be milder than typical pertussis and symptoms usually don’t last as long. In one study, 40% of people with B. parapertussis had no symptoms. B. parapertussis does not produce pertussis toxin and this may affect disease severity. Rarely, children can be coinfected with both B. pertussis and B. parapertussis.
The burden of B. parapertussis in the United States is not well described because only pertussis cases caused by B. pertussis are reportable to the Centers for Disease Control and Prevention. Nevertheless, some states include cases in public reporting and outbreaks have been reported. Historically, disease has been cyclical, with peaks in cases every 4 years and no seasonality.
This year, some communities are currently seeing an increase in B. parapertussis cases. Through June 11 of this year, 40 cases of B. parapertussis and no cases of B. pertussis have been identified at Norton Healthcare in Louisville, Ky. For comparison, one case of B. parapertussis was reported in 2022 and no cases were reported in 2021. Chatter on infectious diseases listservs suggests that clinicians in other communities are also seeing an increase in cases.
According to Andi Shane, MD, MPH, chief of the division of pediatric infectious diseases at Emory University and Children’s Healthcare of Atlanta, an unusually high number of children with B. parapertussis were identified in the Atlanta area this spring. “Fortunately, most children had mild illness and of these, only a few required admission to the hospital,” Dr. Shane said.
Back at the urgent care center, the clinician on duty called the patient’s mom to discuss the diagnosis of B. parapertussis. By the time the test result was available, the patient was asymptomatic. The clinician advised that antibiotic therapy was not indicated.
Treatment recommendations diverge for B. pertussis and B. parapertussis and this is a point of emphasis for clinicians. Treatment of B. pertussis during the catarrhal phase may ameliorate disease. Treatment initiated after the catarrhal phase has little impact on symptoms but may reduce spread to others. In most cases, treatment isn’t recommended for B. parapertussis. It is not clear how well antibiotics work against this organism. Macrolides such as erythromycin and azithromycin that are used to treat pertussis may have some activity, along with trimethoprim-sulfamethoxazole and ciprofloxacin. According to the American Academy of Pediatrics, treatment is usually reserved for individuals at risk for more severe disease, including infants, especially those less than 6 months of age, the elderly, and immunocompromised persons. Prophylactic antibiotic therapy is not recommended for most persons exposed to B. parapertussis, although some public health experts also recommend treatment of B. parapertussis-infected people in contact with young infants and others are risk for severe disease.
In recent epidemiologic reports, patients with B. parapertussis infection had received age-appropriate vaccination for pertussis, suggesting that available pertussis vaccines offer little to no protection against this disease. The best prevention strategies are similar to those that are effective against other illness spread by respiratory droplets. Sick people should stay at home and cover their coughs when around others. Everyone should practice good hand hygiene.
Are you seeing increased cases of B. parapertussis in your community? Email me at [email protected].
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She is a member of the AAP’s Committee on Infectious Diseases and one of the lead authors of the AAP’s Recommendations for Prevention and Control of Influenza in Children, 2022-2023. The opinions expressed in this article are her own. Dr. Bryant discloses that she has served as an investigator on clinical trials funded by Pfizer, Enanta and Gilead. Email her at [email protected].
Tips for addressing uptick in mental health visits: Primary care providers collaborate, innovate
This growth in the number of patients needing behavioral health–related care is likely driven by multiple factors, including a shortage of mental health care providers, an increasing incidence of psychiatric illness, and destigmatization of mental health in general, suggested Swetha P. Iruku, MD, MPH, associate professor of family medicine and community health at the University of Pennsylvania and Penn Medicine family physician in Philadelphia.
The Centers for Disease Control and Prevention noted that “the COVID-19 pandemic has been associated with mental health challenges related to the morbidity and mortality caused by the disease and to mitigation activities, including the impact of physical distancing and stay-at-home orders,” in a Morbidity and Mortality Weekly Report.
From June 24 to 30, 2020, U.S. adults reported considerably elevated adverse mental health conditions associated with COVID-19, and symptoms of anxiety disorder and depressive disorder climbed during the months of April through June of the same year, compared with the same period in 2019, they wrote.
Even before the pandemic got underway, multiple studies of national data published this year suggested mental issues were on the rise in the United States. For example, the proportion of adult patient visits to primary care providers that addressed mental health concerns rose from 10.7% to 15.9% from 2006 to 2018, according to research published in Health Affairs. Plus, the number and proportion of pediatric acute care hospitalizations because of mental health diagnoses increased significantly between 2009 and 2019, according to a paper published in JAMA.
“I truly believe that we can’t, as primary care physicians, take care of someone’s physical health without also taking care of their mental health,” Dr. Iruku said in an interview. “It’s all intertwined.”
To rise to this challenge, PCPs first need a collaborative mindset, she suggested, as well as familiarity with available resources, both locally and virtually.
This article examines strategies for managing mental illness in primary care, outlines clinical resources, and reviews related educational opportunities.
In addition, clinical pearls are shared by Dr. Iruku and five other clinicians who provide or have provided mental health care to primary care patients or work in close collaboration with a primary care practice, including a clinical psychologist, a nurse practitioner licensed in psychiatric health, a pediatrician, and a licensed clinical social worker.
Build a network
Most of the providers interviewed cited the importance of collaboration in mental health care, particularly for complex cases.
“I would recommend [that primary care providers get] to know the psychiatric providers [in their area],” said Jessica Viton, DNP, FNP, PMHNP, who delivers mental health care through a community-based primary care practice in Colorado which she requested remain anonymous.
Dr. Iruku suggested making an in-person connection first, if possible.
“So much of what we do is ‘see one, do one, teach one,’ so learn a little bit, then go off and trial,” she said. “[It can be valuable] having someone in your back pocket that you can contact in the case of an emergency, or in a situation where you just don’t know how to tackle it.”
Screen for depression and anxiety
William J. Sieber, PhD, a clinical psychologist, director of integrated behavioral health, and professor in the department of family medicine and public health and the department of psychiatry at the University of California, San Diego, said primary care providers should screen all adult patients for depression and anxiety with the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder Assessment (GAD-7), respectively.
To save time, he suggested a cascading approach.
“In primary care, everybody’s in a hurry,” Dr. Sieber said. “[With the cascading approach,] the first two items [from each questionnaire] are given, and if a person endorses either of those items … then they are asked to complete the other items.”
Jennifer Mullally, MD, a pediatrician at Sanford Health in Fargo, N.D., uses this cascading approach to depression and anxiety screening with all her patients aged 13-18. For younger kids, she screens only those who present with signs or symptoms of mental health issues, or if the parent shares a concern.
This approach differs slightly from U.S. Preventive Services Task Force recommendations, which suggest screening for anxiety in patients aged 8-18 years and depression in patients aged 12-18 years.
Use other screening tools only as needed
Dr. Sieber, the research director for the division of family medicine at UC San Diego, collaborates regularly with primary care providers via hallway consultations, by sharing cases, and through providing oversight of psychiatric care at 13 primary care practices within the UC San Diego network. He recommended against routine screening beyond depression and anxiety in the primary care setting.
“There are a lot of screening tools,” Dr. Sieber said. “It depends on what you’re presented with. The challenge in primary care is you’re going to see all kinds of things. It’s not like running a depression clinic.”
Other than the PHQ-9 and GAD-7, he suggested primary care providers establish familiarity with screening tools for posttraumatic stress disorder and attention-deficit/hyperactivity disorder, noting again that these should be used only when one of the conditions is already suspected.
Dr. Mullally follows a similar approach with her pediatric population. In addition to the GAD-7, she investigates whether a patient has anxiety with the Screen for Child Anxiety Related Disorders (SCARED). For depression, she couples the PHQ-9 with the Columbia Suicide Severity Rating Scale.
While additional screening tools like these are readily available online, Dr. Viton suggested that they should be employed only if the provider is trained to interpret and respond to those findings, and only if they know which tool to use, and when.
For example, she has recently observed PCPs diagnosing adults with ADHD using a three-question test, when in fact a full-length, standardized instrument should be administered by a provider with necessary training.
She also pointed out that bipolar disorder continues to be underdiagnosed, possibly because of providers detecting depression using a questionnaire like the PHQ-9, while failing to inquire about manic episodes.
Leverage online resources
If depression is confirmed, Dr. Iruku often directs the patient to the Mayo Clinic Depression Medication Choice Decision Aid. This website steers patients through medication options based on their answers to a questionnaire. Choices are listed alongside possible adverse effects.
For clinician use, Dr. Iruku recommended The Waco Guide to Psychopharmacology in Primary Care, which aids clinical decision-making for mental illness and substance abuse. The app processes case details to suggest first-, second-, and third-line pharmacotherapies, as well as modifications based on patient needs.
Even with tools like these, however, a referral may be needed.
“[Primary care providers] may not be the best fit for what the patient is looking for, from a mental health or behavioral standpoint,” Dr. Sieber said.
In this case, he encourages patients to visit Psychology Today, a “quite popular portal” that helps patients locate a suitable provider based on location, insurance, driving radius, and mental health concern. This usually generates 10-20 options, Dr. Sieber said, although results can vary.
“It may be discouraging, because maybe only three [providers] pop up based on your criteria, and the closest one is miles away,” he said.
Consider virtual support
If no local psychiatric help is available, Dr. Sieber suggested virtual support, highlighting that “it’s much easier now than it was 3 or 4 years ago” to connect patients with external mental health care.
But this strategy should be reserved for cases of actual need instead of pure convenience, cautioned Dr. Viton, who noted that virtual visits may fail to capture the nuance of an in-person meeting, as body language, mode of dress, and other clues can provide insights into mental health status.
“Occasionally, I think you do have to have an in-person visit, especially when you’re developing a rapport with someone,” Dr. Viton said.
Claire McArdle, a licensed clinical social worker in Fort Collins, Colo., noted that virtual care from an outside provider may also impede the collaboration needed to effectively address mental illness.
In her 11 years in primary care at Associates in Family Medicine, Ms. McArdle had countless interactions with colleagues seeking support when managing a complex case. “I’m coaching providers, front desk staff, and nursing staff on how to interact with patients [with] behavioral health needs,” she said, citing the multitude of nonmedical factors that need to be considered, such as family relationships and patient preferences.
These unscheduled conversations with colleagues throughout the day are impossible to have when sharing a case with an unknown, remote peer.
Ms. McArdle speaks from experience. She recently resigned from Associates in Family Medicine to start her own private therapy practice after her former employer was acquired by VillageMD, a national provider that terminated employment of most other social workers in the practice and began outsourcing mental health care to Mindoula Health, a virtual provider.
Dr. Sieber offered a similar perspective on in-person collaboration as the psychiatric specialist at his center. He routinely offers on-site support for both providers and patients, serving as “another set of eyes and ears” when there is a concern about patient safety or directly managing care when a patient is hospitalized for mental illness.
While virtual solutions may fall short of in-person management, they can offer care at a scale and cost impossible through traditional practice.
This could even be free. Zero-cost, automated software now allows individuals who are uninsured or unable to afford care at least one avenue to manage their mental health concerns.
For example, Bliss is a free, 8-session, interactive online therapy program for depression that was created by the Centre for Interactive Mental Health Solutions. The program offers a tool for monitoring mood and quizzes to test understanding of personal mental health management, among other features.
More advanced programs are emerging as artificial intelligence (AI) enables dialogues between humans and machines. This is the case with Woebot, an app that asks the user about their mood throughout the day, and responds with evidence-based strategies for managing concerns, all for free at press time.
Keep learning
A range of educational options and professional resources are available for primary care providers who would like to improve their knowledge of mental health care. These include formal fellowships in primary care psychiatry/behavioral health integration, free mental health webinars, and various other opportunities.
Eric Eschweiler, DNP, APRN, FNP-C, PHN, completed the University of California, Irvine, Train New Trainers (TNT) Primary Care Psychiatry (PCP) Fellowship in 2016, when he was working as a solo nurse practitioner.
“I was drowning in practice,” said Dr. Eschweiler, director of nursing and public health outreach services at Riverside-San Bernardino County Indian Health, Grand Terrace, Calif., in an interview. “I was a solo NP. There was no physician on site. We were seeing a lot of [individuals with] schizoaffective [disorder] in downtown San Bernardino, the homeless, unhoused – a lot of substance use. I felt I needed to have the skills to be able to treat them effectively. That’s what the fellowship did.”
The skills Dr. Eschweiler learned from participating in his fellowship allowed him to manage more cases of mental illness without need for referral. When a referral was needed for a complex or severe case, he had the confidence to bridge care and collaborate more effectively with psychiatric specialists.
“It was awesome, because we were able to communicate using the same language,” Dr. Eschweiler said of these collaborations. “It’s [about] talking that same language, starting those initial treatments, and then moving forward with specialty care, and vice versa. [Psychiatric specialists] would send me patients that needed medical care because of the types of medications they were taking. And I was then very well aware of those side effects and other issues that might come up from those treatments. So it’s a two-way street.”
Dr. Eschweiler was so impressed by his fellowship that he has since ushered multiple providers through the program since transitioning to an administrative role as director of nursing.
In Fargo, where psychiatric care is sparse and wait times for referral can be months long, Dr. Mullally, like Dr. Eschweiler, knew that she needed more training in mental health.
“I don’t feel like we get enough training in residency,” Dr. Mullally said. “So you do need to look at your options for further CME.”
Out of several CME courses she has taken to further her understanding of pediatric psychiatry, Dr. Mullally recommended The Reach Institute above all others, as their courses involve in-depth discussions and valuable handouts, particularly for medication selection.
“I think that a lot of the other CMEs tend to involve a lot more PowerPoint presentations,” Dr. Mullally said. “And you don’t necessarily leave with a lot of good documents. I still use my Reach handouts. I have them sitting right next to me. I use them every single day.”
Providers interested in The Reach Institute, however, should be prepared to invest both time and money, she added, citing a 2-3 day commitment, and calling it “not cheap.” To overcome these barriers, she suggested that providers get their institution to support their attendance.
For a lighter commitment, Dr. Iruku recommended the American Academy of Family Physicians CME portal, as this offers 13 online, accredited courses covering a range of topics, from adolescent health to substance abuse disorders.
Dr. Sieber suggested that primary care providers join the Collaborative Family Healthcare Association, which aims to integrate physical and behavioral health in routine practice. CFHA, of which he is a member, offers a “bevy of different resources” for interested providers, including a conference in Phoenix this October.
The interviewees disclosed no conflicts of interest.
This growth in the number of patients needing behavioral health–related care is likely driven by multiple factors, including a shortage of mental health care providers, an increasing incidence of psychiatric illness, and destigmatization of mental health in general, suggested Swetha P. Iruku, MD, MPH, associate professor of family medicine and community health at the University of Pennsylvania and Penn Medicine family physician in Philadelphia.
The Centers for Disease Control and Prevention noted that “the COVID-19 pandemic has been associated with mental health challenges related to the morbidity and mortality caused by the disease and to mitigation activities, including the impact of physical distancing and stay-at-home orders,” in a Morbidity and Mortality Weekly Report.
From June 24 to 30, 2020, U.S. adults reported considerably elevated adverse mental health conditions associated with COVID-19, and symptoms of anxiety disorder and depressive disorder climbed during the months of April through June of the same year, compared with the same period in 2019, they wrote.
Even before the pandemic got underway, multiple studies of national data published this year suggested mental issues were on the rise in the United States. For example, the proportion of adult patient visits to primary care providers that addressed mental health concerns rose from 10.7% to 15.9% from 2006 to 2018, according to research published in Health Affairs. Plus, the number and proportion of pediatric acute care hospitalizations because of mental health diagnoses increased significantly between 2009 and 2019, according to a paper published in JAMA.
“I truly believe that we can’t, as primary care physicians, take care of someone’s physical health without also taking care of their mental health,” Dr. Iruku said in an interview. “It’s all intertwined.”
To rise to this challenge, PCPs first need a collaborative mindset, she suggested, as well as familiarity with available resources, both locally and virtually.
This article examines strategies for managing mental illness in primary care, outlines clinical resources, and reviews related educational opportunities.
In addition, clinical pearls are shared by Dr. Iruku and five other clinicians who provide or have provided mental health care to primary care patients or work in close collaboration with a primary care practice, including a clinical psychologist, a nurse practitioner licensed in psychiatric health, a pediatrician, and a licensed clinical social worker.
Build a network
Most of the providers interviewed cited the importance of collaboration in mental health care, particularly for complex cases.
“I would recommend [that primary care providers get] to know the psychiatric providers [in their area],” said Jessica Viton, DNP, FNP, PMHNP, who delivers mental health care through a community-based primary care practice in Colorado which she requested remain anonymous.
Dr. Iruku suggested making an in-person connection first, if possible.
“So much of what we do is ‘see one, do one, teach one,’ so learn a little bit, then go off and trial,” she said. “[It can be valuable] having someone in your back pocket that you can contact in the case of an emergency, or in a situation where you just don’t know how to tackle it.”
Screen for depression and anxiety
William J. Sieber, PhD, a clinical psychologist, director of integrated behavioral health, and professor in the department of family medicine and public health and the department of psychiatry at the University of California, San Diego, said primary care providers should screen all adult patients for depression and anxiety with the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder Assessment (GAD-7), respectively.
To save time, he suggested a cascading approach.
“In primary care, everybody’s in a hurry,” Dr. Sieber said. “[With the cascading approach,] the first two items [from each questionnaire] are given, and if a person endorses either of those items … then they are asked to complete the other items.”
Jennifer Mullally, MD, a pediatrician at Sanford Health in Fargo, N.D., uses this cascading approach to depression and anxiety screening with all her patients aged 13-18. For younger kids, she screens only those who present with signs or symptoms of mental health issues, or if the parent shares a concern.
This approach differs slightly from U.S. Preventive Services Task Force recommendations, which suggest screening for anxiety in patients aged 8-18 years and depression in patients aged 12-18 years.
Use other screening tools only as needed
Dr. Sieber, the research director for the division of family medicine at UC San Diego, collaborates regularly with primary care providers via hallway consultations, by sharing cases, and through providing oversight of psychiatric care at 13 primary care practices within the UC San Diego network. He recommended against routine screening beyond depression and anxiety in the primary care setting.
“There are a lot of screening tools,” Dr. Sieber said. “It depends on what you’re presented with. The challenge in primary care is you’re going to see all kinds of things. It’s not like running a depression clinic.”
Other than the PHQ-9 and GAD-7, he suggested primary care providers establish familiarity with screening tools for posttraumatic stress disorder and attention-deficit/hyperactivity disorder, noting again that these should be used only when one of the conditions is already suspected.
Dr. Mullally follows a similar approach with her pediatric population. In addition to the GAD-7, she investigates whether a patient has anxiety with the Screen for Child Anxiety Related Disorders (SCARED). For depression, she couples the PHQ-9 with the Columbia Suicide Severity Rating Scale.
While additional screening tools like these are readily available online, Dr. Viton suggested that they should be employed only if the provider is trained to interpret and respond to those findings, and only if they know which tool to use, and when.
For example, she has recently observed PCPs diagnosing adults with ADHD using a three-question test, when in fact a full-length, standardized instrument should be administered by a provider with necessary training.
She also pointed out that bipolar disorder continues to be underdiagnosed, possibly because of providers detecting depression using a questionnaire like the PHQ-9, while failing to inquire about manic episodes.
Leverage online resources
If depression is confirmed, Dr. Iruku often directs the patient to the Mayo Clinic Depression Medication Choice Decision Aid. This website steers patients through medication options based on their answers to a questionnaire. Choices are listed alongside possible adverse effects.
For clinician use, Dr. Iruku recommended The Waco Guide to Psychopharmacology in Primary Care, which aids clinical decision-making for mental illness and substance abuse. The app processes case details to suggest first-, second-, and third-line pharmacotherapies, as well as modifications based on patient needs.
Even with tools like these, however, a referral may be needed.
“[Primary care providers] may not be the best fit for what the patient is looking for, from a mental health or behavioral standpoint,” Dr. Sieber said.
In this case, he encourages patients to visit Psychology Today, a “quite popular portal” that helps patients locate a suitable provider based on location, insurance, driving radius, and mental health concern. This usually generates 10-20 options, Dr. Sieber said, although results can vary.
“It may be discouraging, because maybe only three [providers] pop up based on your criteria, and the closest one is miles away,” he said.
Consider virtual support
If no local psychiatric help is available, Dr. Sieber suggested virtual support, highlighting that “it’s much easier now than it was 3 or 4 years ago” to connect patients with external mental health care.
But this strategy should be reserved for cases of actual need instead of pure convenience, cautioned Dr. Viton, who noted that virtual visits may fail to capture the nuance of an in-person meeting, as body language, mode of dress, and other clues can provide insights into mental health status.
“Occasionally, I think you do have to have an in-person visit, especially when you’re developing a rapport with someone,” Dr. Viton said.
Claire McArdle, a licensed clinical social worker in Fort Collins, Colo., noted that virtual care from an outside provider may also impede the collaboration needed to effectively address mental illness.
In her 11 years in primary care at Associates in Family Medicine, Ms. McArdle had countless interactions with colleagues seeking support when managing a complex case. “I’m coaching providers, front desk staff, and nursing staff on how to interact with patients [with] behavioral health needs,” she said, citing the multitude of nonmedical factors that need to be considered, such as family relationships and patient preferences.
These unscheduled conversations with colleagues throughout the day are impossible to have when sharing a case with an unknown, remote peer.
Ms. McArdle speaks from experience. She recently resigned from Associates in Family Medicine to start her own private therapy practice after her former employer was acquired by VillageMD, a national provider that terminated employment of most other social workers in the practice and began outsourcing mental health care to Mindoula Health, a virtual provider.
Dr. Sieber offered a similar perspective on in-person collaboration as the psychiatric specialist at his center. He routinely offers on-site support for both providers and patients, serving as “another set of eyes and ears” when there is a concern about patient safety or directly managing care when a patient is hospitalized for mental illness.
While virtual solutions may fall short of in-person management, they can offer care at a scale and cost impossible through traditional practice.
This could even be free. Zero-cost, automated software now allows individuals who are uninsured or unable to afford care at least one avenue to manage their mental health concerns.
For example, Bliss is a free, 8-session, interactive online therapy program for depression that was created by the Centre for Interactive Mental Health Solutions. The program offers a tool for monitoring mood and quizzes to test understanding of personal mental health management, among other features.
More advanced programs are emerging as artificial intelligence (AI) enables dialogues between humans and machines. This is the case with Woebot, an app that asks the user about their mood throughout the day, and responds with evidence-based strategies for managing concerns, all for free at press time.
Keep learning
A range of educational options and professional resources are available for primary care providers who would like to improve their knowledge of mental health care. These include formal fellowships in primary care psychiatry/behavioral health integration, free mental health webinars, and various other opportunities.
Eric Eschweiler, DNP, APRN, FNP-C, PHN, completed the University of California, Irvine, Train New Trainers (TNT) Primary Care Psychiatry (PCP) Fellowship in 2016, when he was working as a solo nurse practitioner.
“I was drowning in practice,” said Dr. Eschweiler, director of nursing and public health outreach services at Riverside-San Bernardino County Indian Health, Grand Terrace, Calif., in an interview. “I was a solo NP. There was no physician on site. We were seeing a lot of [individuals with] schizoaffective [disorder] in downtown San Bernardino, the homeless, unhoused – a lot of substance use. I felt I needed to have the skills to be able to treat them effectively. That’s what the fellowship did.”
The skills Dr. Eschweiler learned from participating in his fellowship allowed him to manage more cases of mental illness without need for referral. When a referral was needed for a complex or severe case, he had the confidence to bridge care and collaborate more effectively with psychiatric specialists.
“It was awesome, because we were able to communicate using the same language,” Dr. Eschweiler said of these collaborations. “It’s [about] talking that same language, starting those initial treatments, and then moving forward with specialty care, and vice versa. [Psychiatric specialists] would send me patients that needed medical care because of the types of medications they were taking. And I was then very well aware of those side effects and other issues that might come up from those treatments. So it’s a two-way street.”
Dr. Eschweiler was so impressed by his fellowship that he has since ushered multiple providers through the program since transitioning to an administrative role as director of nursing.
In Fargo, where psychiatric care is sparse and wait times for referral can be months long, Dr. Mullally, like Dr. Eschweiler, knew that she needed more training in mental health.
“I don’t feel like we get enough training in residency,” Dr. Mullally said. “So you do need to look at your options for further CME.”
Out of several CME courses she has taken to further her understanding of pediatric psychiatry, Dr. Mullally recommended The Reach Institute above all others, as their courses involve in-depth discussions and valuable handouts, particularly for medication selection.
“I think that a lot of the other CMEs tend to involve a lot more PowerPoint presentations,” Dr. Mullally said. “And you don’t necessarily leave with a lot of good documents. I still use my Reach handouts. I have them sitting right next to me. I use them every single day.”
Providers interested in The Reach Institute, however, should be prepared to invest both time and money, she added, citing a 2-3 day commitment, and calling it “not cheap.” To overcome these barriers, she suggested that providers get their institution to support their attendance.
For a lighter commitment, Dr. Iruku recommended the American Academy of Family Physicians CME portal, as this offers 13 online, accredited courses covering a range of topics, from adolescent health to substance abuse disorders.
Dr. Sieber suggested that primary care providers join the Collaborative Family Healthcare Association, which aims to integrate physical and behavioral health in routine practice. CFHA, of which he is a member, offers a “bevy of different resources” for interested providers, including a conference in Phoenix this October.
The interviewees disclosed no conflicts of interest.
This growth in the number of patients needing behavioral health–related care is likely driven by multiple factors, including a shortage of mental health care providers, an increasing incidence of psychiatric illness, and destigmatization of mental health in general, suggested Swetha P. Iruku, MD, MPH, associate professor of family medicine and community health at the University of Pennsylvania and Penn Medicine family physician in Philadelphia.
The Centers for Disease Control and Prevention noted that “the COVID-19 pandemic has been associated with mental health challenges related to the morbidity and mortality caused by the disease and to mitigation activities, including the impact of physical distancing and stay-at-home orders,” in a Morbidity and Mortality Weekly Report.
From June 24 to 30, 2020, U.S. adults reported considerably elevated adverse mental health conditions associated with COVID-19, and symptoms of anxiety disorder and depressive disorder climbed during the months of April through June of the same year, compared with the same period in 2019, they wrote.
Even before the pandemic got underway, multiple studies of national data published this year suggested mental issues were on the rise in the United States. For example, the proportion of adult patient visits to primary care providers that addressed mental health concerns rose from 10.7% to 15.9% from 2006 to 2018, according to research published in Health Affairs. Plus, the number and proportion of pediatric acute care hospitalizations because of mental health diagnoses increased significantly between 2009 and 2019, according to a paper published in JAMA.
“I truly believe that we can’t, as primary care physicians, take care of someone’s physical health without also taking care of their mental health,” Dr. Iruku said in an interview. “It’s all intertwined.”
To rise to this challenge, PCPs first need a collaborative mindset, she suggested, as well as familiarity with available resources, both locally and virtually.
This article examines strategies for managing mental illness in primary care, outlines clinical resources, and reviews related educational opportunities.
In addition, clinical pearls are shared by Dr. Iruku and five other clinicians who provide or have provided mental health care to primary care patients or work in close collaboration with a primary care practice, including a clinical psychologist, a nurse practitioner licensed in psychiatric health, a pediatrician, and a licensed clinical social worker.
Build a network
Most of the providers interviewed cited the importance of collaboration in mental health care, particularly for complex cases.
“I would recommend [that primary care providers get] to know the psychiatric providers [in their area],” said Jessica Viton, DNP, FNP, PMHNP, who delivers mental health care through a community-based primary care practice in Colorado which she requested remain anonymous.
Dr. Iruku suggested making an in-person connection first, if possible.
“So much of what we do is ‘see one, do one, teach one,’ so learn a little bit, then go off and trial,” she said. “[It can be valuable] having someone in your back pocket that you can contact in the case of an emergency, or in a situation where you just don’t know how to tackle it.”
Screen for depression and anxiety
William J. Sieber, PhD, a clinical psychologist, director of integrated behavioral health, and professor in the department of family medicine and public health and the department of psychiatry at the University of California, San Diego, said primary care providers should screen all adult patients for depression and anxiety with the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder Assessment (GAD-7), respectively.
To save time, he suggested a cascading approach.
“In primary care, everybody’s in a hurry,” Dr. Sieber said. “[With the cascading approach,] the first two items [from each questionnaire] are given, and if a person endorses either of those items … then they are asked to complete the other items.”
Jennifer Mullally, MD, a pediatrician at Sanford Health in Fargo, N.D., uses this cascading approach to depression and anxiety screening with all her patients aged 13-18. For younger kids, she screens only those who present with signs or symptoms of mental health issues, or if the parent shares a concern.
This approach differs slightly from U.S. Preventive Services Task Force recommendations, which suggest screening for anxiety in patients aged 8-18 years and depression in patients aged 12-18 years.
Use other screening tools only as needed
Dr. Sieber, the research director for the division of family medicine at UC San Diego, collaborates regularly with primary care providers via hallway consultations, by sharing cases, and through providing oversight of psychiatric care at 13 primary care practices within the UC San Diego network. He recommended against routine screening beyond depression and anxiety in the primary care setting.
“There are a lot of screening tools,” Dr. Sieber said. “It depends on what you’re presented with. The challenge in primary care is you’re going to see all kinds of things. It’s not like running a depression clinic.”
Other than the PHQ-9 and GAD-7, he suggested primary care providers establish familiarity with screening tools for posttraumatic stress disorder and attention-deficit/hyperactivity disorder, noting again that these should be used only when one of the conditions is already suspected.
Dr. Mullally follows a similar approach with her pediatric population. In addition to the GAD-7, she investigates whether a patient has anxiety with the Screen for Child Anxiety Related Disorders (SCARED). For depression, she couples the PHQ-9 with the Columbia Suicide Severity Rating Scale.
While additional screening tools like these are readily available online, Dr. Viton suggested that they should be employed only if the provider is trained to interpret and respond to those findings, and only if they know which tool to use, and when.
For example, she has recently observed PCPs diagnosing adults with ADHD using a three-question test, when in fact a full-length, standardized instrument should be administered by a provider with necessary training.
She also pointed out that bipolar disorder continues to be underdiagnosed, possibly because of providers detecting depression using a questionnaire like the PHQ-9, while failing to inquire about manic episodes.
Leverage online resources
If depression is confirmed, Dr. Iruku often directs the patient to the Mayo Clinic Depression Medication Choice Decision Aid. This website steers patients through medication options based on their answers to a questionnaire. Choices are listed alongside possible adverse effects.
For clinician use, Dr. Iruku recommended The Waco Guide to Psychopharmacology in Primary Care, which aids clinical decision-making for mental illness and substance abuse. The app processes case details to suggest first-, second-, and third-line pharmacotherapies, as well as modifications based on patient needs.
Even with tools like these, however, a referral may be needed.
“[Primary care providers] may not be the best fit for what the patient is looking for, from a mental health or behavioral standpoint,” Dr. Sieber said.
In this case, he encourages patients to visit Psychology Today, a “quite popular portal” that helps patients locate a suitable provider based on location, insurance, driving radius, and mental health concern. This usually generates 10-20 options, Dr. Sieber said, although results can vary.
“It may be discouraging, because maybe only three [providers] pop up based on your criteria, and the closest one is miles away,” he said.
Consider virtual support
If no local psychiatric help is available, Dr. Sieber suggested virtual support, highlighting that “it’s much easier now than it was 3 or 4 years ago” to connect patients with external mental health care.
But this strategy should be reserved for cases of actual need instead of pure convenience, cautioned Dr. Viton, who noted that virtual visits may fail to capture the nuance of an in-person meeting, as body language, mode of dress, and other clues can provide insights into mental health status.
“Occasionally, I think you do have to have an in-person visit, especially when you’re developing a rapport with someone,” Dr. Viton said.
Claire McArdle, a licensed clinical social worker in Fort Collins, Colo., noted that virtual care from an outside provider may also impede the collaboration needed to effectively address mental illness.
In her 11 years in primary care at Associates in Family Medicine, Ms. McArdle had countless interactions with colleagues seeking support when managing a complex case. “I’m coaching providers, front desk staff, and nursing staff on how to interact with patients [with] behavioral health needs,” she said, citing the multitude of nonmedical factors that need to be considered, such as family relationships and patient preferences.
These unscheduled conversations with colleagues throughout the day are impossible to have when sharing a case with an unknown, remote peer.
Ms. McArdle speaks from experience. She recently resigned from Associates in Family Medicine to start her own private therapy practice after her former employer was acquired by VillageMD, a national provider that terminated employment of most other social workers in the practice and began outsourcing mental health care to Mindoula Health, a virtual provider.
Dr. Sieber offered a similar perspective on in-person collaboration as the psychiatric specialist at his center. He routinely offers on-site support for both providers and patients, serving as “another set of eyes and ears” when there is a concern about patient safety or directly managing care when a patient is hospitalized for mental illness.
While virtual solutions may fall short of in-person management, they can offer care at a scale and cost impossible through traditional practice.
This could even be free. Zero-cost, automated software now allows individuals who are uninsured or unable to afford care at least one avenue to manage their mental health concerns.
For example, Bliss is a free, 8-session, interactive online therapy program for depression that was created by the Centre for Interactive Mental Health Solutions. The program offers a tool for monitoring mood and quizzes to test understanding of personal mental health management, among other features.
More advanced programs are emerging as artificial intelligence (AI) enables dialogues between humans and machines. This is the case with Woebot, an app that asks the user about their mood throughout the day, and responds with evidence-based strategies for managing concerns, all for free at press time.
Keep learning
A range of educational options and professional resources are available for primary care providers who would like to improve their knowledge of mental health care. These include formal fellowships in primary care psychiatry/behavioral health integration, free mental health webinars, and various other opportunities.
Eric Eschweiler, DNP, APRN, FNP-C, PHN, completed the University of California, Irvine, Train New Trainers (TNT) Primary Care Psychiatry (PCP) Fellowship in 2016, when he was working as a solo nurse practitioner.
“I was drowning in practice,” said Dr. Eschweiler, director of nursing and public health outreach services at Riverside-San Bernardino County Indian Health, Grand Terrace, Calif., in an interview. “I was a solo NP. There was no physician on site. We were seeing a lot of [individuals with] schizoaffective [disorder] in downtown San Bernardino, the homeless, unhoused – a lot of substance use. I felt I needed to have the skills to be able to treat them effectively. That’s what the fellowship did.”
The skills Dr. Eschweiler learned from participating in his fellowship allowed him to manage more cases of mental illness without need for referral. When a referral was needed for a complex or severe case, he had the confidence to bridge care and collaborate more effectively with psychiatric specialists.
“It was awesome, because we were able to communicate using the same language,” Dr. Eschweiler said of these collaborations. “It’s [about] talking that same language, starting those initial treatments, and then moving forward with specialty care, and vice versa. [Psychiatric specialists] would send me patients that needed medical care because of the types of medications they were taking. And I was then very well aware of those side effects and other issues that might come up from those treatments. So it’s a two-way street.”
Dr. Eschweiler was so impressed by his fellowship that he has since ushered multiple providers through the program since transitioning to an administrative role as director of nursing.
In Fargo, where psychiatric care is sparse and wait times for referral can be months long, Dr. Mullally, like Dr. Eschweiler, knew that she needed more training in mental health.
“I don’t feel like we get enough training in residency,” Dr. Mullally said. “So you do need to look at your options for further CME.”
Out of several CME courses she has taken to further her understanding of pediatric psychiatry, Dr. Mullally recommended The Reach Institute above all others, as their courses involve in-depth discussions and valuable handouts, particularly for medication selection.
“I think that a lot of the other CMEs tend to involve a lot more PowerPoint presentations,” Dr. Mullally said. “And you don’t necessarily leave with a lot of good documents. I still use my Reach handouts. I have them sitting right next to me. I use them every single day.”
Providers interested in The Reach Institute, however, should be prepared to invest both time and money, she added, citing a 2-3 day commitment, and calling it “not cheap.” To overcome these barriers, she suggested that providers get their institution to support their attendance.
For a lighter commitment, Dr. Iruku recommended the American Academy of Family Physicians CME portal, as this offers 13 online, accredited courses covering a range of topics, from adolescent health to substance abuse disorders.
Dr. Sieber suggested that primary care providers join the Collaborative Family Healthcare Association, which aims to integrate physical and behavioral health in routine practice. CFHA, of which he is a member, offers a “bevy of different resources” for interested providers, including a conference in Phoenix this October.
The interviewees disclosed no conflicts of interest.
Teen depression and dyslipidemia: New data
TOPLINE
Mean lipid levels are similar among adolescents with and without major depressive disorder (MDD), as is the proportion of adolescents with borderline-high lipid levels.
METHODOLOGY
Teen depression is associated with an increased likelihood of experiencing cardiovascular (CV) events, with dyslipidemia being a potentially modifiable risk factor.
Only a few studies have examined the association between depression and lipids during adolescence, when confounding comorbidities such as obesity and diabetes are less common.
The study included 243 adolescents (186 with MDD and 57 healthy controls [HCs]) who were mostly female and had a mean age of 15 years.
Researchers assessed CV risk factors including body mass index (BMI), blood pressure, smoking status, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride (TG), which were classified as acceptable or borderline high.
Dyslipidemia was defined as having concentration of at least one lipid outside the acceptable range.
TAKEAWAY
Most participants in both groups had lipid concentrations within the acceptable range.
There were no differences between study groups in mean lipid levels after adjusting for age, sex, and standardized BMI.
There were also no differences in the proportion of adolescents with borderline-high lipid concentrations.
IN PRACTICE
“Taken together, results of the current study support the need for further examination of the relationship between gender, depression, and cholesterol,” the authors write.
STUDY DETAILS
The study was conducted by Anisa F. Khalfan, Neurosciences and Mental Health research program, SickKids Research Institute, Toronto, Canada, and colleagues. It was published online in the Journal of Affective Disorders.
LIMITATIONS
The HC group was relatively small, which might have contributed to the null findings. The mean Center for Epidemiologic Studies Depression Scale for Children (CES-DC) score was 8.3 among healthy youth, compared with 37.5 among MDD youth, limiting detection of an association related to depression severity.
DISCLOSURES
The study was supported by the Lunenfeld Summer Studentship. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE
Mean lipid levels are similar among adolescents with and without major depressive disorder (MDD), as is the proportion of adolescents with borderline-high lipid levels.
METHODOLOGY
Teen depression is associated with an increased likelihood of experiencing cardiovascular (CV) events, with dyslipidemia being a potentially modifiable risk factor.
Only a few studies have examined the association between depression and lipids during adolescence, when confounding comorbidities such as obesity and diabetes are less common.
The study included 243 adolescents (186 with MDD and 57 healthy controls [HCs]) who were mostly female and had a mean age of 15 years.
Researchers assessed CV risk factors including body mass index (BMI), blood pressure, smoking status, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride (TG), which were classified as acceptable or borderline high.
Dyslipidemia was defined as having concentration of at least one lipid outside the acceptable range.
TAKEAWAY
Most participants in both groups had lipid concentrations within the acceptable range.
There were no differences between study groups in mean lipid levels after adjusting for age, sex, and standardized BMI.
There were also no differences in the proportion of adolescents with borderline-high lipid concentrations.
IN PRACTICE
“Taken together, results of the current study support the need for further examination of the relationship between gender, depression, and cholesterol,” the authors write.
STUDY DETAILS
The study was conducted by Anisa F. Khalfan, Neurosciences and Mental Health research program, SickKids Research Institute, Toronto, Canada, and colleagues. It was published online in the Journal of Affective Disorders.
LIMITATIONS
The HC group was relatively small, which might have contributed to the null findings. The mean Center for Epidemiologic Studies Depression Scale for Children (CES-DC) score was 8.3 among healthy youth, compared with 37.5 among MDD youth, limiting detection of an association related to depression severity.
DISCLOSURES
The study was supported by the Lunenfeld Summer Studentship. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
TOPLINE
Mean lipid levels are similar among adolescents with and without major depressive disorder (MDD), as is the proportion of adolescents with borderline-high lipid levels.
METHODOLOGY
Teen depression is associated with an increased likelihood of experiencing cardiovascular (CV) events, with dyslipidemia being a potentially modifiable risk factor.
Only a few studies have examined the association between depression and lipids during adolescence, when confounding comorbidities such as obesity and diabetes are less common.
The study included 243 adolescents (186 with MDD and 57 healthy controls [HCs]) who were mostly female and had a mean age of 15 years.
Researchers assessed CV risk factors including body mass index (BMI), blood pressure, smoking status, total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, and triglyceride (TG), which were classified as acceptable or borderline high.
Dyslipidemia was defined as having concentration of at least one lipid outside the acceptable range.
TAKEAWAY
Most participants in both groups had lipid concentrations within the acceptable range.
There were no differences between study groups in mean lipid levels after adjusting for age, sex, and standardized BMI.
There were also no differences in the proportion of adolescents with borderline-high lipid concentrations.
IN PRACTICE
“Taken together, results of the current study support the need for further examination of the relationship between gender, depression, and cholesterol,” the authors write.
STUDY DETAILS
The study was conducted by Anisa F. Khalfan, Neurosciences and Mental Health research program, SickKids Research Institute, Toronto, Canada, and colleagues. It was published online in the Journal of Affective Disorders.
LIMITATIONS
The HC group was relatively small, which might have contributed to the null findings. The mean Center for Epidemiologic Studies Depression Scale for Children (CES-DC) score was 8.3 among healthy youth, compared with 37.5 among MDD youth, limiting detection of an association related to depression severity.
DISCLOSURES
The study was supported by the Lunenfeld Summer Studentship. The authors report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
After Yusimry’s steep discount, little clarity on future adalimumab biosimilar pricing
Adalimumab, sold under the brand name Humira, enjoyed a long run as one of the world’s best-selling medicines. But its 20-year, competition-free period has ended, and despite its best efforts to delay their arrival, drug manufacturer AbbVie now faces increasing competition from biosimilars entering the marketplace.
But one biosimilar about to be launched may be something of a game changer. Coherus BioSciences has announced plans to market its biosimilar Yusimry (adalimumab-aqvh) at a cost of $995 for two autoinjectors. This represents an approximate 85% discount over Humira’s sale list price of $6922.
This price, however, is slated to plunge even further as Coherus has also revealed that it will work with the Mark Cuban Cost Plus Drug Company (MCCPDC) to offer an even lower price. When Yusimry launches in July, it will sell for about $579 for two autoinjectors, making it the lowest-priced adalimumab biosimilar on the market.
“Coherus and Cost Plus Drug Company share a common mission, to increase access to high-quality medicine for patients at an affordable price,” said Dennis Lanfear, MBA, president, CEO and chairman of Coherus. “Mark Cuban and his team offer innovative solutions to health care problems, and Coherus is also a highly innovative company focused on unmet patient needs.”
He noted that, with adalimumab biosimilar pricing, this translates to a low list price approach. “We are pleased that Yusimry will be a part of that, as the first biologic they carry,” Mr. Lanfear said.
MCCPDC prices are based on the cost of ingredients and manufacturing plus 15% margin, a $3 pharmacy dispensing fee, and a $5 shipping fee. The company has expanded its inventory from 100 generics to more than 350 medications since it launched in January 2022. While MCCPDC is primarily directed to people who are paying cash for drugs, it does take insurance from select plans. And even for people who are covered by other insurers, the cost of drugs from Mr. Cuban’s company may be less than their out-of-pocket costs if they did go through their payer.
The low pricing of Yusimry is welcome, said Marcus Snow, MD, an assistant professor in the division of rheumatology at the University of Nebraska Medical Center, Omaha, but he pointed out that it is still a very expensive drug. “For patients who can’t afford Humira due to poor insurance coverage and high out-of-pocket costs, it is a welcome option. But it’s also unclear how many patients who lack adequate health insurance coverage can afford to pay $579 a month out of their own pockets.”
The biosimilars are coming
By early December 2022, the Food and Drug Administration had approved seven Humira biosimilars, and Amgen launched the first biosimilar to come on the market, Amjevita, soon afterward. By July 2023, half a dozen more are expected to enter the marketplace, said Steven Horvitz, managing director of EMC Analytics Group, a pharmaceutical research firm.
Mr. Horvitz agrees that the system is out of control, but it is unclear how much of an effect the low price tag on the Coherus product will have. “Some insurers may say, ‘we want the lowest price, and we don’t care about rebates,’ and will go with it,” he said. “PBMs [pharmacy benefit managers] are all about economics, so we have to see how many of their major clients will ask for the lowest price.”
Amgen has more or less followed the status quo on pricing for its biosimilar, but with a twist. It›s being offered at two different prices: $85,494 a year, which is only a 5% discount from Humira’s list price, or at $40,497 a year, a 55% discount. However, to date, the lower price has generally not been granted favorable formulary placement by PBMs. The plans that adopt the higher-priced biosimilar will get bigger rebates, but patients with coinsurance and deductibles will pay more out of pocket.
It is yet unknown how the pricing on Yusimry will affect the biosimilars ready to launch. “Will it give them pause for thought or not make any difference?” Mr. Horvitz said. “The companies do not reveal their pricing before the fact, so we have to wait and see.”
Large PBMs have not jumped at the opportunity to offer the Coherus biosimilar, but SmithRx, which bills itself as “next-generation pharmacy benefits management,” announced that it will offer Yusimry to its members at a discount of more than 90%.
“Unlike traditional PBMs, SmithRx prioritizes transparency and up-front cost savings. Humira is often an employer’s top drug expense so offering a low-cost alternative will have significant impact,” Jake Frenz, CEO and founder of SmithRx, said in a statement. “We’re excited to work with Cost Plus Drugs to bring this biosimilar to our members – and significantly reduce costs for them and their employers.”
A version of this article first appeared on Medscape.com.
Adalimumab, sold under the brand name Humira, enjoyed a long run as one of the world’s best-selling medicines. But its 20-year, competition-free period has ended, and despite its best efforts to delay their arrival, drug manufacturer AbbVie now faces increasing competition from biosimilars entering the marketplace.
But one biosimilar about to be launched may be something of a game changer. Coherus BioSciences has announced plans to market its biosimilar Yusimry (adalimumab-aqvh) at a cost of $995 for two autoinjectors. This represents an approximate 85% discount over Humira’s sale list price of $6922.
This price, however, is slated to plunge even further as Coherus has also revealed that it will work with the Mark Cuban Cost Plus Drug Company (MCCPDC) to offer an even lower price. When Yusimry launches in July, it will sell for about $579 for two autoinjectors, making it the lowest-priced adalimumab biosimilar on the market.
“Coherus and Cost Plus Drug Company share a common mission, to increase access to high-quality medicine for patients at an affordable price,” said Dennis Lanfear, MBA, president, CEO and chairman of Coherus. “Mark Cuban and his team offer innovative solutions to health care problems, and Coherus is also a highly innovative company focused on unmet patient needs.”
He noted that, with adalimumab biosimilar pricing, this translates to a low list price approach. “We are pleased that Yusimry will be a part of that, as the first biologic they carry,” Mr. Lanfear said.
MCCPDC prices are based on the cost of ingredients and manufacturing plus 15% margin, a $3 pharmacy dispensing fee, and a $5 shipping fee. The company has expanded its inventory from 100 generics to more than 350 medications since it launched in January 2022. While MCCPDC is primarily directed to people who are paying cash for drugs, it does take insurance from select plans. And even for people who are covered by other insurers, the cost of drugs from Mr. Cuban’s company may be less than their out-of-pocket costs if they did go through their payer.
The low pricing of Yusimry is welcome, said Marcus Snow, MD, an assistant professor in the division of rheumatology at the University of Nebraska Medical Center, Omaha, but he pointed out that it is still a very expensive drug. “For patients who can’t afford Humira due to poor insurance coverage and high out-of-pocket costs, it is a welcome option. But it’s also unclear how many patients who lack adequate health insurance coverage can afford to pay $579 a month out of their own pockets.”
The biosimilars are coming
By early December 2022, the Food and Drug Administration had approved seven Humira biosimilars, and Amgen launched the first biosimilar to come on the market, Amjevita, soon afterward. By July 2023, half a dozen more are expected to enter the marketplace, said Steven Horvitz, managing director of EMC Analytics Group, a pharmaceutical research firm.
Mr. Horvitz agrees that the system is out of control, but it is unclear how much of an effect the low price tag on the Coherus product will have. “Some insurers may say, ‘we want the lowest price, and we don’t care about rebates,’ and will go with it,” he said. “PBMs [pharmacy benefit managers] are all about economics, so we have to see how many of their major clients will ask for the lowest price.”
Amgen has more or less followed the status quo on pricing for its biosimilar, but with a twist. It›s being offered at two different prices: $85,494 a year, which is only a 5% discount from Humira’s list price, or at $40,497 a year, a 55% discount. However, to date, the lower price has generally not been granted favorable formulary placement by PBMs. The plans that adopt the higher-priced biosimilar will get bigger rebates, but patients with coinsurance and deductibles will pay more out of pocket.
It is yet unknown how the pricing on Yusimry will affect the biosimilars ready to launch. “Will it give them pause for thought or not make any difference?” Mr. Horvitz said. “The companies do not reveal their pricing before the fact, so we have to wait and see.”
Large PBMs have not jumped at the opportunity to offer the Coherus biosimilar, but SmithRx, which bills itself as “next-generation pharmacy benefits management,” announced that it will offer Yusimry to its members at a discount of more than 90%.
“Unlike traditional PBMs, SmithRx prioritizes transparency and up-front cost savings. Humira is often an employer’s top drug expense so offering a low-cost alternative will have significant impact,” Jake Frenz, CEO and founder of SmithRx, said in a statement. “We’re excited to work with Cost Plus Drugs to bring this biosimilar to our members – and significantly reduce costs for them and their employers.”
A version of this article first appeared on Medscape.com.
Adalimumab, sold under the brand name Humira, enjoyed a long run as one of the world’s best-selling medicines. But its 20-year, competition-free period has ended, and despite its best efforts to delay their arrival, drug manufacturer AbbVie now faces increasing competition from biosimilars entering the marketplace.
But one biosimilar about to be launched may be something of a game changer. Coherus BioSciences has announced plans to market its biosimilar Yusimry (adalimumab-aqvh) at a cost of $995 for two autoinjectors. This represents an approximate 85% discount over Humira’s sale list price of $6922.
This price, however, is slated to plunge even further as Coherus has also revealed that it will work with the Mark Cuban Cost Plus Drug Company (MCCPDC) to offer an even lower price. When Yusimry launches in July, it will sell for about $579 for two autoinjectors, making it the lowest-priced adalimumab biosimilar on the market.
“Coherus and Cost Plus Drug Company share a common mission, to increase access to high-quality medicine for patients at an affordable price,” said Dennis Lanfear, MBA, president, CEO and chairman of Coherus. “Mark Cuban and his team offer innovative solutions to health care problems, and Coherus is also a highly innovative company focused on unmet patient needs.”
He noted that, with adalimumab biosimilar pricing, this translates to a low list price approach. “We are pleased that Yusimry will be a part of that, as the first biologic they carry,” Mr. Lanfear said.
MCCPDC prices are based on the cost of ingredients and manufacturing plus 15% margin, a $3 pharmacy dispensing fee, and a $5 shipping fee. The company has expanded its inventory from 100 generics to more than 350 medications since it launched in January 2022. While MCCPDC is primarily directed to people who are paying cash for drugs, it does take insurance from select plans. And even for people who are covered by other insurers, the cost of drugs from Mr. Cuban’s company may be less than their out-of-pocket costs if they did go through their payer.
The low pricing of Yusimry is welcome, said Marcus Snow, MD, an assistant professor in the division of rheumatology at the University of Nebraska Medical Center, Omaha, but he pointed out that it is still a very expensive drug. “For patients who can’t afford Humira due to poor insurance coverage and high out-of-pocket costs, it is a welcome option. But it’s also unclear how many patients who lack adequate health insurance coverage can afford to pay $579 a month out of their own pockets.”
The biosimilars are coming
By early December 2022, the Food and Drug Administration had approved seven Humira biosimilars, and Amgen launched the first biosimilar to come on the market, Amjevita, soon afterward. By July 2023, half a dozen more are expected to enter the marketplace, said Steven Horvitz, managing director of EMC Analytics Group, a pharmaceutical research firm.
Mr. Horvitz agrees that the system is out of control, but it is unclear how much of an effect the low price tag on the Coherus product will have. “Some insurers may say, ‘we want the lowest price, and we don’t care about rebates,’ and will go with it,” he said. “PBMs [pharmacy benefit managers] are all about economics, so we have to see how many of their major clients will ask for the lowest price.”
Amgen has more or less followed the status quo on pricing for its biosimilar, but with a twist. It›s being offered at two different prices: $85,494 a year, which is only a 5% discount from Humira’s list price, or at $40,497 a year, a 55% discount. However, to date, the lower price has generally not been granted favorable formulary placement by PBMs. The plans that adopt the higher-priced biosimilar will get bigger rebates, but patients with coinsurance and deductibles will pay more out of pocket.
It is yet unknown how the pricing on Yusimry will affect the biosimilars ready to launch. “Will it give them pause for thought or not make any difference?” Mr. Horvitz said. “The companies do not reveal their pricing before the fact, so we have to wait and see.”
Large PBMs have not jumped at the opportunity to offer the Coherus biosimilar, but SmithRx, which bills itself as “next-generation pharmacy benefits management,” announced that it will offer Yusimry to its members at a discount of more than 90%.
“Unlike traditional PBMs, SmithRx prioritizes transparency and up-front cost savings. Humira is often an employer’s top drug expense so offering a low-cost alternative will have significant impact,” Jake Frenz, CEO and founder of SmithRx, said in a statement. “We’re excited to work with Cost Plus Drugs to bring this biosimilar to our members – and significantly reduce costs for them and their employers.”
A version of this article first appeared on Medscape.com.
Experts share their sun protection tips for children
“I basically say, ‘sun protection means clothing, shade, [considering the] time of day of exposure, and sunscreen if you are going to be otherwise exposed,’ ” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego, said during a panel discussion about sunscreen use at the Hawaii Dermatology Seminar provided by MedscapeLIVE! He recommends photoprotective gear such as rash guards for surfers and other water sport enthusiasts. When patients ask him if they should use sunscreen, he often replies with a question of his own.
“Do you brush your teeth?” he’ll ask.
“Yes, I do.”
“Well, you should put sunscreen on every day.”
Another panelist, Adelaide A. Hebert, MD, professor of dermatology and pediatrics and chief of pediatric dermatology at the University of Texas, Houston, said that she advises new parents to start sun protection efforts early. “Most sunscreens are not approved for use in children under the age of 6 months because testing has not been done in this age group, but I do recommend protective clothing. I also recommend wrap-around sunglasses, which offer 5% more protection from the sun than regular sunglasses.”
In her opinion, stick sunscreens are “a good add-on,” especially for under the eyes and the backs of the hands, but she is not a fan of spray sunscreens, which can leave large areas of skin unprotected if not applied properly.
Fellow panelist Jennifer Huang, MD, a pediatric dermatologist at Boston Children’s Hospital, who has a special interest in taking care of dermatologic conditions of children with cancer, generally recommends mineral-based sunscreens. “There is data to suggest that nonmineral sunscreens are less safe than mineral sunscreens for humans, and mineral sunscreens are considered to be better for the environment,” Dr. Huang said. “Plus, there are more elegant versions of mineral sunscreens that don’t make your skin pasty white.” However, for patients with darker skin tones, “it can be hard to apply a pasty white sunscreen, so I lean on some recommendations for tinted sunscreens, too, so there are options. I specifically recommend sunscreens that have iron oxides in them so that it can block physical rays and help with the cosmetic appearance.”
Moise Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, said that his approach to imparting sunscreen advice to children and their parents involves a mix of spoken information, printed information, and sunscreen samples for children to try in the office, in the presence of a parent. To help patients choose among different samples, be they ointments, gels, or lotions, he will often ask the child: “‘What do you like the feel of better?’ If the child says, ‘I like this one,’ I make sure the parent hears that,” Dr. Levy said.
Next, Dr. Eichenfield, who moderated the discussion, asked his fellow panelists how they would counsel someone who comes to their practice for evaluation of moles and has a family history of nonmelanoma skin cancer. “I think this is one of the easier counseling sessions, because there are enough kids who are asked about the moles on their skin when they’re at school,” Dr. Hebert said. “I think they’re very ready to wear sun protective clothing and I certainly don’t want any sun exposure that would pose an increased risk for their child.”
In addition to routine sun protection, Dr. Huang recommends annual mole checks for children who have a first-degree relative with a history of malignant melanoma. Other high-risk groups that should undergo annual skin exams include anyone who has received high doses of radiation, bone marrow transplants, prolonged use of voriconazole, or prolonged systemic immunosuppression. Without a known genetic predisposition syndrome, a family history of nonmelanoma skin cancer would not raise concern for melanoma in an otherwise healthy child.
Dr. Eichenfield added that freckling used to be the secondary risk factor for melanoma, “but it’s flipped over to a primary risk factor. A history of immunosuppression or prior cancer is a major risk factor in childhood and teenage years.”
Dr. Eichenfield disclosed that he is a consultant or adviser for numerous pharmaceutical companies. He has also received research funding from AbbVie, Bausch & Lomb, Galderma Laboratories, and Pfizer. Dr. Hebert disclosed that she is a consultant or adviser for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica. Dr. Levy disclosed that he is consultant or adviser for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. Dr. Huang disclosed that she is an adviser for EllaOla.
MedscapeLive! and this news organization are owned by the same parent company.
“I basically say, ‘sun protection means clothing, shade, [considering the] time of day of exposure, and sunscreen if you are going to be otherwise exposed,’ ” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego, said during a panel discussion about sunscreen use at the Hawaii Dermatology Seminar provided by MedscapeLIVE! He recommends photoprotective gear such as rash guards for surfers and other water sport enthusiasts. When patients ask him if they should use sunscreen, he often replies with a question of his own.
“Do you brush your teeth?” he’ll ask.
“Yes, I do.”
“Well, you should put sunscreen on every day.”
Another panelist, Adelaide A. Hebert, MD, professor of dermatology and pediatrics and chief of pediatric dermatology at the University of Texas, Houston, said that she advises new parents to start sun protection efforts early. “Most sunscreens are not approved for use in children under the age of 6 months because testing has not been done in this age group, but I do recommend protective clothing. I also recommend wrap-around sunglasses, which offer 5% more protection from the sun than regular sunglasses.”
In her opinion, stick sunscreens are “a good add-on,” especially for under the eyes and the backs of the hands, but she is not a fan of spray sunscreens, which can leave large areas of skin unprotected if not applied properly.
Fellow panelist Jennifer Huang, MD, a pediatric dermatologist at Boston Children’s Hospital, who has a special interest in taking care of dermatologic conditions of children with cancer, generally recommends mineral-based sunscreens. “There is data to suggest that nonmineral sunscreens are less safe than mineral sunscreens for humans, and mineral sunscreens are considered to be better for the environment,” Dr. Huang said. “Plus, there are more elegant versions of mineral sunscreens that don’t make your skin pasty white.” However, for patients with darker skin tones, “it can be hard to apply a pasty white sunscreen, so I lean on some recommendations for tinted sunscreens, too, so there are options. I specifically recommend sunscreens that have iron oxides in them so that it can block physical rays and help with the cosmetic appearance.”
Moise Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, said that his approach to imparting sunscreen advice to children and their parents involves a mix of spoken information, printed information, and sunscreen samples for children to try in the office, in the presence of a parent. To help patients choose among different samples, be they ointments, gels, or lotions, he will often ask the child: “‘What do you like the feel of better?’ If the child says, ‘I like this one,’ I make sure the parent hears that,” Dr. Levy said.
Next, Dr. Eichenfield, who moderated the discussion, asked his fellow panelists how they would counsel someone who comes to their practice for evaluation of moles and has a family history of nonmelanoma skin cancer. “I think this is one of the easier counseling sessions, because there are enough kids who are asked about the moles on their skin when they’re at school,” Dr. Hebert said. “I think they’re very ready to wear sun protective clothing and I certainly don’t want any sun exposure that would pose an increased risk for their child.”
In addition to routine sun protection, Dr. Huang recommends annual mole checks for children who have a first-degree relative with a history of malignant melanoma. Other high-risk groups that should undergo annual skin exams include anyone who has received high doses of radiation, bone marrow transplants, prolonged use of voriconazole, or prolonged systemic immunosuppression. Without a known genetic predisposition syndrome, a family history of nonmelanoma skin cancer would not raise concern for melanoma in an otherwise healthy child.
Dr. Eichenfield added that freckling used to be the secondary risk factor for melanoma, “but it’s flipped over to a primary risk factor. A history of immunosuppression or prior cancer is a major risk factor in childhood and teenage years.”
Dr. Eichenfield disclosed that he is a consultant or adviser for numerous pharmaceutical companies. He has also received research funding from AbbVie, Bausch & Lomb, Galderma Laboratories, and Pfizer. Dr. Hebert disclosed that she is a consultant or adviser for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica. Dr. Levy disclosed that he is consultant or adviser for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. Dr. Huang disclosed that she is an adviser for EllaOla.
MedscapeLive! and this news organization are owned by the same parent company.
“I basically say, ‘sun protection means clothing, shade, [considering the] time of day of exposure, and sunscreen if you are going to be otherwise exposed,’ ” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego, said during a panel discussion about sunscreen use at the Hawaii Dermatology Seminar provided by MedscapeLIVE! He recommends photoprotective gear such as rash guards for surfers and other water sport enthusiasts. When patients ask him if they should use sunscreen, he often replies with a question of his own.
“Do you brush your teeth?” he’ll ask.
“Yes, I do.”
“Well, you should put sunscreen on every day.”
Another panelist, Adelaide A. Hebert, MD, professor of dermatology and pediatrics and chief of pediatric dermatology at the University of Texas, Houston, said that she advises new parents to start sun protection efforts early. “Most sunscreens are not approved for use in children under the age of 6 months because testing has not been done in this age group, but I do recommend protective clothing. I also recommend wrap-around sunglasses, which offer 5% more protection from the sun than regular sunglasses.”
In her opinion, stick sunscreens are “a good add-on,” especially for under the eyes and the backs of the hands, but she is not a fan of spray sunscreens, which can leave large areas of skin unprotected if not applied properly.
Fellow panelist Jennifer Huang, MD, a pediatric dermatologist at Boston Children’s Hospital, who has a special interest in taking care of dermatologic conditions of children with cancer, generally recommends mineral-based sunscreens. “There is data to suggest that nonmineral sunscreens are less safe than mineral sunscreens for humans, and mineral sunscreens are considered to be better for the environment,” Dr. Huang said. “Plus, there are more elegant versions of mineral sunscreens that don’t make your skin pasty white.” However, for patients with darker skin tones, “it can be hard to apply a pasty white sunscreen, so I lean on some recommendations for tinted sunscreens, too, so there are options. I specifically recommend sunscreens that have iron oxides in them so that it can block physical rays and help with the cosmetic appearance.”
Moise Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, said that his approach to imparting sunscreen advice to children and their parents involves a mix of spoken information, printed information, and sunscreen samples for children to try in the office, in the presence of a parent. To help patients choose among different samples, be they ointments, gels, or lotions, he will often ask the child: “‘What do you like the feel of better?’ If the child says, ‘I like this one,’ I make sure the parent hears that,” Dr. Levy said.
Next, Dr. Eichenfield, who moderated the discussion, asked his fellow panelists how they would counsel someone who comes to their practice for evaluation of moles and has a family history of nonmelanoma skin cancer. “I think this is one of the easier counseling sessions, because there are enough kids who are asked about the moles on their skin when they’re at school,” Dr. Hebert said. “I think they’re very ready to wear sun protective clothing and I certainly don’t want any sun exposure that would pose an increased risk for their child.”
In addition to routine sun protection, Dr. Huang recommends annual mole checks for children who have a first-degree relative with a history of malignant melanoma. Other high-risk groups that should undergo annual skin exams include anyone who has received high doses of radiation, bone marrow transplants, prolonged use of voriconazole, or prolonged systemic immunosuppression. Without a known genetic predisposition syndrome, a family history of nonmelanoma skin cancer would not raise concern for melanoma in an otherwise healthy child.
Dr. Eichenfield added that freckling used to be the secondary risk factor for melanoma, “but it’s flipped over to a primary risk factor. A history of immunosuppression or prior cancer is a major risk factor in childhood and teenage years.”
Dr. Eichenfield disclosed that he is a consultant or adviser for numerous pharmaceutical companies. He has also received research funding from AbbVie, Bausch & Lomb, Galderma Laboratories, and Pfizer. Dr. Hebert disclosed that she is a consultant or adviser for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica. Dr. Levy disclosed that he is consultant or adviser for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. Dr. Huang disclosed that she is an adviser for EllaOla.
MedscapeLive! and this news organization are owned by the same parent company.
FROM THE MEDSCAPELIVE! HAWAII DERMATOLOGY SEMINAR
ACS officer provides ASCO highlights: Targeting hidden cancer, AI in oncology
And it didn’t just sparkle because of the sequined Taylor Swift fans clogging the nearby streets during the meeting.
Arif Kamal, MD, MBA, MHS, who is also an oncologist at Duke University, Durham, N.C., said he was impressed by a pair of landmark studies released at the meeting that show hidden cancer can be targeted with “really remarkable outcomes.” He also highlighted sessions that examined the role of artificial intelligence (AI) in oncology, during an interview.
Below are lightly edited excerpts from a conversation with Dr. Kamal:
Question: What are some of most groundbreaking studies released at ASCO?
Answer: One is an interim analysis of the NATALEE trial, which involved patients with early-stage hormone receptor-positive, HER2-negative (HR+/HER2–) breast tumors. This phase 3 randomized trial compared maintenance therapy with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib (Kisqali) plus endocrine therapy with an aromatase inhibitor to endocrine therapy alone in patients with node-positive or node-negative and stage II or III HR+/HER– breast cancer.
For a long time, the standard care in these patients has been to use endocrine therapy alone. This is the first big trial to show that upstream usage of additional therapy in early stages is also beneficial for disease-free survival. The 3-year invasive disease-free survival rate was 90.4% in the rebociclib-endocrine therapy group vs. 87.1% for patients who received only endocrine therapy (P = .0014).
Q: How do these findings add to current knowledge?
A: Typically, we let people get metastatic disease before we use CDK4/6 inhibitors. These findings show that systemic treatment beyond endocrine therapy will be helpful in cases where you’ve got smaller disease that has not spread yet.
Even in patients with node-negative breast cancer, micrometastatic disease is clearly there, because the medication killed the negative lymph nodes.
Q: What else struck you as especially important research?
A: The NATALEE findings match what we saw in another study – the ADAURA trial, which looked at adjuvant osimertinib in non–small-cell lung cancer patients with EGFR-mutated, stage IB to IIIA disease – cancer that has not spread to the lymph nodes.
This is another example where you have a treatment being used in earlier-stage disease that’s showing really remarkable outcomes. The study found that 5-year overall survival was 88% in an osimertinib group vs. 78% in a placebo group (P < .001). This is a disease where, in stage IB, we wouldn’t even necessarily give these patients treatment at all, other than surgical resection of the tumor and maybe give them a little bit of chemotherapy.
Even in these smaller, early tumors, osimertinib makes a difference.
Q: As a whole, what are these studies telling us about cancer cells that can’t be easily detected?
A: To find a disease-free survival benefit with adding ribociclib in a stage II, stage III setting, particularly in node-negative disease, is remarkable because it says that the cells in hiding are bad actors, and they are going to cause trouble. The study shows that medications can find these cells and reverse that risk of bad outcomes.
If you think about the paradigm of cancer, that’s pretty remarkable because the ADAURA trial does the same thing: You do surgery for [early-stage] lung cancers that have not spread to the lymph nodes and you figure, “Well, I’ve got it all, right? The margins are real big, healthy, clean.” And yet, people still have recurrences, and you ask the same question: “Can any medicine find those few cells, the hundreds of cells that are still left somewhere in hiding?” And the answer is again, yes. It’s changing the paradigm of our understanding of minimal residual disease.
That’s why there’s so much interest in liquid biopsies. Let’s say that after treatment we don’t see any cancer radiologically, but there’s a signal from a liquid biopsy [detecting residual cancer]. These two trials demonstrate that there’s something we can do about it.
Q: There were quite a few studies about artificial intelligence released at ASCO. Where do we stand on that front?
A: We’re just at the beginning of people thinking about the use of generative AI for clinical decision support, clinical trial matching, and pathology review. But AI, at least for now, still has the issue of making up things that aren’t true. That’s not something patients are going to be okay with.
Q: How can AI be helpful to medical providers considering its limitations?
A: AI is going to be very good at the data-to-information transition. You’ll start seeing people use AI to start clinical notes for them and to match patients to the best clinical trials for them. But fundamentally, the clinician’s role will continue to be to check facts and offer wisdom.
Q: Will AI threaten the careers of oncologists?
A: The body of knowledge about oncology is growing exponentially, and no one can actually keep up. There’s so much data that’s out there that needs to be turned into usable information amid a shortage of oncologists. At the same time, the prevalence of cancer is going up, even though mortality is going down.
Synthesis of data is what oncologists are waiting for from AI. They’ll welcome it as opposed to being worried. That’s the sentiment I heard from my colleagues.
Dr. Kamal has no disclosures.
And it didn’t just sparkle because of the sequined Taylor Swift fans clogging the nearby streets during the meeting.
Arif Kamal, MD, MBA, MHS, who is also an oncologist at Duke University, Durham, N.C., said he was impressed by a pair of landmark studies released at the meeting that show hidden cancer can be targeted with “really remarkable outcomes.” He also highlighted sessions that examined the role of artificial intelligence (AI) in oncology, during an interview.
Below are lightly edited excerpts from a conversation with Dr. Kamal:
Question: What are some of most groundbreaking studies released at ASCO?
Answer: One is an interim analysis of the NATALEE trial, which involved patients with early-stage hormone receptor-positive, HER2-negative (HR+/HER2–) breast tumors. This phase 3 randomized trial compared maintenance therapy with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib (Kisqali) plus endocrine therapy with an aromatase inhibitor to endocrine therapy alone in patients with node-positive or node-negative and stage II or III HR+/HER– breast cancer.
For a long time, the standard care in these patients has been to use endocrine therapy alone. This is the first big trial to show that upstream usage of additional therapy in early stages is also beneficial for disease-free survival. The 3-year invasive disease-free survival rate was 90.4% in the rebociclib-endocrine therapy group vs. 87.1% for patients who received only endocrine therapy (P = .0014).
Q: How do these findings add to current knowledge?
A: Typically, we let people get metastatic disease before we use CDK4/6 inhibitors. These findings show that systemic treatment beyond endocrine therapy will be helpful in cases where you’ve got smaller disease that has not spread yet.
Even in patients with node-negative breast cancer, micrometastatic disease is clearly there, because the medication killed the negative lymph nodes.
Q: What else struck you as especially important research?
A: The NATALEE findings match what we saw in another study – the ADAURA trial, which looked at adjuvant osimertinib in non–small-cell lung cancer patients with EGFR-mutated, stage IB to IIIA disease – cancer that has not spread to the lymph nodes.
This is another example where you have a treatment being used in earlier-stage disease that’s showing really remarkable outcomes. The study found that 5-year overall survival was 88% in an osimertinib group vs. 78% in a placebo group (P < .001). This is a disease where, in stage IB, we wouldn’t even necessarily give these patients treatment at all, other than surgical resection of the tumor and maybe give them a little bit of chemotherapy.
Even in these smaller, early tumors, osimertinib makes a difference.
Q: As a whole, what are these studies telling us about cancer cells that can’t be easily detected?
A: To find a disease-free survival benefit with adding ribociclib in a stage II, stage III setting, particularly in node-negative disease, is remarkable because it says that the cells in hiding are bad actors, and they are going to cause trouble. The study shows that medications can find these cells and reverse that risk of bad outcomes.
If you think about the paradigm of cancer, that’s pretty remarkable because the ADAURA trial does the same thing: You do surgery for [early-stage] lung cancers that have not spread to the lymph nodes and you figure, “Well, I’ve got it all, right? The margins are real big, healthy, clean.” And yet, people still have recurrences, and you ask the same question: “Can any medicine find those few cells, the hundreds of cells that are still left somewhere in hiding?” And the answer is again, yes. It’s changing the paradigm of our understanding of minimal residual disease.
That’s why there’s so much interest in liquid biopsies. Let’s say that after treatment we don’t see any cancer radiologically, but there’s a signal from a liquid biopsy [detecting residual cancer]. These two trials demonstrate that there’s something we can do about it.
Q: There were quite a few studies about artificial intelligence released at ASCO. Where do we stand on that front?
A: We’re just at the beginning of people thinking about the use of generative AI for clinical decision support, clinical trial matching, and pathology review. But AI, at least for now, still has the issue of making up things that aren’t true. That’s not something patients are going to be okay with.
Q: How can AI be helpful to medical providers considering its limitations?
A: AI is going to be very good at the data-to-information transition. You’ll start seeing people use AI to start clinical notes for them and to match patients to the best clinical trials for them. But fundamentally, the clinician’s role will continue to be to check facts and offer wisdom.
Q: Will AI threaten the careers of oncologists?
A: The body of knowledge about oncology is growing exponentially, and no one can actually keep up. There’s so much data that’s out there that needs to be turned into usable information amid a shortage of oncologists. At the same time, the prevalence of cancer is going up, even though mortality is going down.
Synthesis of data is what oncologists are waiting for from AI. They’ll welcome it as opposed to being worried. That’s the sentiment I heard from my colleagues.
Dr. Kamal has no disclosures.
And it didn’t just sparkle because of the sequined Taylor Swift fans clogging the nearby streets during the meeting.
Arif Kamal, MD, MBA, MHS, who is also an oncologist at Duke University, Durham, N.C., said he was impressed by a pair of landmark studies released at the meeting that show hidden cancer can be targeted with “really remarkable outcomes.” He also highlighted sessions that examined the role of artificial intelligence (AI) in oncology, during an interview.
Below are lightly edited excerpts from a conversation with Dr. Kamal:
Question: What are some of most groundbreaking studies released at ASCO?
Answer: One is an interim analysis of the NATALEE trial, which involved patients with early-stage hormone receptor-positive, HER2-negative (HR+/HER2–) breast tumors. This phase 3 randomized trial compared maintenance therapy with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib (Kisqali) plus endocrine therapy with an aromatase inhibitor to endocrine therapy alone in patients with node-positive or node-negative and stage II or III HR+/HER– breast cancer.
For a long time, the standard care in these patients has been to use endocrine therapy alone. This is the first big trial to show that upstream usage of additional therapy in early stages is also beneficial for disease-free survival. The 3-year invasive disease-free survival rate was 90.4% in the rebociclib-endocrine therapy group vs. 87.1% for patients who received only endocrine therapy (P = .0014).
Q: How do these findings add to current knowledge?
A: Typically, we let people get metastatic disease before we use CDK4/6 inhibitors. These findings show that systemic treatment beyond endocrine therapy will be helpful in cases where you’ve got smaller disease that has not spread yet.
Even in patients with node-negative breast cancer, micrometastatic disease is clearly there, because the medication killed the negative lymph nodes.
Q: What else struck you as especially important research?
A: The NATALEE findings match what we saw in another study – the ADAURA trial, which looked at adjuvant osimertinib in non–small-cell lung cancer patients with EGFR-mutated, stage IB to IIIA disease – cancer that has not spread to the lymph nodes.
This is another example where you have a treatment being used in earlier-stage disease that’s showing really remarkable outcomes. The study found that 5-year overall survival was 88% in an osimertinib group vs. 78% in a placebo group (P < .001). This is a disease where, in stage IB, we wouldn’t even necessarily give these patients treatment at all, other than surgical resection of the tumor and maybe give them a little bit of chemotherapy.
Even in these smaller, early tumors, osimertinib makes a difference.
Q: As a whole, what are these studies telling us about cancer cells that can’t be easily detected?
A: To find a disease-free survival benefit with adding ribociclib in a stage II, stage III setting, particularly in node-negative disease, is remarkable because it says that the cells in hiding are bad actors, and they are going to cause trouble. The study shows that medications can find these cells and reverse that risk of bad outcomes.
If you think about the paradigm of cancer, that’s pretty remarkable because the ADAURA trial does the same thing: You do surgery for [early-stage] lung cancers that have not spread to the lymph nodes and you figure, “Well, I’ve got it all, right? The margins are real big, healthy, clean.” And yet, people still have recurrences, and you ask the same question: “Can any medicine find those few cells, the hundreds of cells that are still left somewhere in hiding?” And the answer is again, yes. It’s changing the paradigm of our understanding of minimal residual disease.
That’s why there’s so much interest in liquid biopsies. Let’s say that after treatment we don’t see any cancer radiologically, but there’s a signal from a liquid biopsy [detecting residual cancer]. These two trials demonstrate that there’s something we can do about it.
Q: There were quite a few studies about artificial intelligence released at ASCO. Where do we stand on that front?
A: We’re just at the beginning of people thinking about the use of generative AI for clinical decision support, clinical trial matching, and pathology review. But AI, at least for now, still has the issue of making up things that aren’t true. That’s not something patients are going to be okay with.
Q: How can AI be helpful to medical providers considering its limitations?
A: AI is going to be very good at the data-to-information transition. You’ll start seeing people use AI to start clinical notes for them and to match patients to the best clinical trials for them. But fundamentally, the clinician’s role will continue to be to check facts and offer wisdom.
Q: Will AI threaten the careers of oncologists?
A: The body of knowledge about oncology is growing exponentially, and no one can actually keep up. There’s so much data that’s out there that needs to be turned into usable information amid a shortage of oncologists. At the same time, the prevalence of cancer is going up, even though mortality is going down.
Synthesis of data is what oncologists are waiting for from AI. They’ll welcome it as opposed to being worried. That’s the sentiment I heard from my colleagues.
Dr. Kamal has no disclosures.
AT ASCO 2023