Pediatrics

Ecopipam, in development for Tourette syndrome in children and adolescents, has shown in a randomized, controlled trial that, compared with placebo, it reduced tics and reduced the risk for some of the common side effects of other treatments, including weight gain.

Findings of the multicenter, double-blind, trial funded by the drug maker, Emalex Biosciences, were published online in Pediatrics. The trial was conducted at 68 sites in the United States, Canada, Germany, France, and Poland between May 2019 and September 2021.

Donald L. Gilbert, MD, MS, with the division of neurology at Cincinnati Children’s Hospital, and colleagues noted that all Food and Drug Administration–approved medications for Tourette syndrome are antipsychotics. The medications carry a risk of weight gain, electrocardiogram abnormalities, metabolic changes, and drug-induced movement disorders.

First-in-class medication ecopipam, targets the D1 dopamine receptor, while currently approved medications block the D2 receptor. It “may be a safe and effective treatment of Tourette syndrome with advantages over other currently approved therapeutic agents,” the authors wrote.

The study included 153 individuals at least 6 years old up to age 18 with a baseline Yale Global Tic Severity Score Total Tic Score of at least 20.

They were randomly assigned 1:1 to ecopipam or placebo.
 

Significant reduction in tic severity

Researchers saw a 30% reduction in the tic severity score from baseline to week 12 for the ecopipam group compared with the placebo group.

The data showed a least-squares mean difference of 3.44 (95% confidence interval [CI], 6.09-0.79, P = .01). Researchers also saw improvement in Clinical Global Impression of Tourette Syndrome Severity in the ecopipam group (P = .03).

Sara Pawlowski, MD, division chief for primary care mental health integration at University of Vermont Health Network and assistant professor of psychiatry, University of Vermont, Burlington, said in an interview that several things should be considered with this research.

One is that, though the results show a reduction in tics, the study lasted only 12 weeks and “tics can last a lifetime,” she noted.

“They also can ebb and flow with major life events, stressors, and various other variables. So, I wonder how the effects of improvement can be teased out from the natural ebb and flow of the condition in a 3-month window, which is a snapshot into the course of a known relapsing, remitting, lifetime, and chronically variable condition,” she said.
 

Headaches, insomnia among side effects

Weight gain was larger in the placebo group than in the ecopipam group: 17.1% in the ecopipam group and 20.3% of those who got a placebo had a weight gain of more than 7% over the study period.

The most common side effects of the study drug were headache (15.8%), insomnia (14.5%), fatigue (7.9%), and somnolence (7.9%).

A limitation of the study was lack of racial and ethnic diversity, as 93.5% of those in the placebo group and 86.8% in the ecopipam group were White.

Guidelines in North America and Europe agree that behavioral treatments should be the first-line therapy.

Dr. Pawlowski said that although effective medications are needed, she urges focusing on better access to nonmedication treatments “that work for children and adolescents” as children who start taking the medications early may take them for the rest of their lives.

Also, while the research didn’t find weight gain in the ecopipam group, the side effects they did find in the group, including headache and insomnia, “do impact a child’s life,” she noted.

“We also can’t be reassured that over the course of chronic treatment there wouldn’t be movement disorders or metabolic disorders that emerge. Those are side effects or disorders that can emerge surreptitiously over time, and more time than 12 weeks,” she said.

The study was funded by Emalex Biosciences. Dr. Gilbert has received consulting fees from Biogen and PTC therapeutics. Study coauthors disclosed ties with Emalex, Alkermes, and Paragon Biosciences. Dr. Pawlowski reports no relevant financial relationships.

Ecopipam, in development for Tourette syndrome in children and adolescents, has shown in a randomized, controlled trial that, compared with placebo, it reduced tics and reduced the risk for some of the common side effects of other treatments, including weight gain.

Findings of the multicenter, double-blind, trial funded by the drug maker, Emalex Biosciences, were published online in Pediatrics. The trial was conducted at 68 sites in the United States, Canada, Germany, France, and Poland between May 2019 and September 2021.

Donald L. Gilbert, MD, MS, with the division of neurology at Cincinnati Children’s Hospital, and colleagues noted that all Food and Drug Administration–approved medications for Tourette syndrome are antipsychotics. The medications carry a risk of weight gain, electrocardiogram abnormalities, metabolic changes, and drug-induced movement disorders.

First-in-class medication ecopipam, targets the D1 dopamine receptor, while currently approved medications block the D2 receptor. It “may be a safe and effective treatment of Tourette syndrome with advantages over other currently approved therapeutic agents,” the authors wrote.

The study included 153 individuals at least 6 years old up to age 18 with a baseline Yale Global Tic Severity Score Total Tic Score of at least 20.

They were randomly assigned 1:1 to ecopipam or placebo.
 

Significant reduction in tic severity

Researchers saw a 30% reduction in the tic severity score from baseline to week 12 for the ecopipam group compared with the placebo group.

The data showed a least-squares mean difference of 3.44 (95% confidence interval [CI], 6.09-0.79, P = .01). Researchers also saw improvement in Clinical Global Impression of Tourette Syndrome Severity in the ecopipam group (P = .03).

Sara Pawlowski, MD, division chief for primary care mental health integration at University of Vermont Health Network and assistant professor of psychiatry, University of Vermont, Burlington, said in an interview that several things should be considered with this research.

One is that, though the results show a reduction in tics, the study lasted only 12 weeks and “tics can last a lifetime,” she noted.

“They also can ebb and flow with major life events, stressors, and various other variables. So, I wonder how the effects of improvement can be teased out from the natural ebb and flow of the condition in a 3-month window, which is a snapshot into the course of a known relapsing, remitting, lifetime, and chronically variable condition,” she said.
 

Headaches, insomnia among side effects

Weight gain was larger in the placebo group than in the ecopipam group: 17.1% in the ecopipam group and 20.3% of those who got a placebo had a weight gain of more than 7% over the study period.

The most common side effects of the study drug were headache (15.8%), insomnia (14.5%), fatigue (7.9%), and somnolence (7.9%).

A limitation of the study was lack of racial and ethnic diversity, as 93.5% of those in the placebo group and 86.8% in the ecopipam group were White.

Guidelines in North America and Europe agree that behavioral treatments should be the first-line therapy.

Dr. Pawlowski said that although effective medications are needed, she urges focusing on better access to nonmedication treatments “that work for children and adolescents” as children who start taking the medications early may take them for the rest of their lives.

Also, while the research didn’t find weight gain in the ecopipam group, the side effects they did find in the group, including headache and insomnia, “do impact a child’s life,” she noted.

“We also can’t be reassured that over the course of chronic treatment there wouldn’t be movement disorders or metabolic disorders that emerge. Those are side effects or disorders that can emerge surreptitiously over time, and more time than 12 weeks,” she said.

The study was funded by Emalex Biosciences. Dr. Gilbert has received consulting fees from Biogen and PTC therapeutics. Study coauthors disclosed ties with Emalex, Alkermes, and Paragon Biosciences. Dr. Pawlowski reports no relevant financial relationships.

Ecopipam, in development for Tourette syndrome in children and adolescents, has shown in a randomized, controlled trial that, compared with placebo, it reduced tics and reduced the risk for some of the common side effects of other treatments, including weight gain.

Findings of the multicenter, double-blind, trial funded by the drug maker, Emalex Biosciences, were published online in Pediatrics. The trial was conducted at 68 sites in the United States, Canada, Germany, France, and Poland between May 2019 and September 2021.

Donald L. Gilbert, MD, MS, with the division of neurology at Cincinnati Children’s Hospital, and colleagues noted that all Food and Drug Administration–approved medications for Tourette syndrome are antipsychotics. The medications carry a risk of weight gain, electrocardiogram abnormalities, metabolic changes, and drug-induced movement disorders.

First-in-class medication ecopipam, targets the D1 dopamine receptor, while currently approved medications block the D2 receptor. It “may be a safe and effective treatment of Tourette syndrome with advantages over other currently approved therapeutic agents,” the authors wrote.

The study included 153 individuals at least 6 years old up to age 18 with a baseline Yale Global Tic Severity Score Total Tic Score of at least 20.

They were randomly assigned 1:1 to ecopipam or placebo.
 

Significant reduction in tic severity

Researchers saw a 30% reduction in the tic severity score from baseline to week 12 for the ecopipam group compared with the placebo group.

The data showed a least-squares mean difference of 3.44 (95% confidence interval [CI], 6.09-0.79, P = .01). Researchers also saw improvement in Clinical Global Impression of Tourette Syndrome Severity in the ecopipam group (P = .03).

Sara Pawlowski, MD, division chief for primary care mental health integration at University of Vermont Health Network and assistant professor of psychiatry, University of Vermont, Burlington, said in an interview that several things should be considered with this research.

One is that, though the results show a reduction in tics, the study lasted only 12 weeks and “tics can last a lifetime,” she noted.

“They also can ebb and flow with major life events, stressors, and various other variables. So, I wonder how the effects of improvement can be teased out from the natural ebb and flow of the condition in a 3-month window, which is a snapshot into the course of a known relapsing, remitting, lifetime, and chronically variable condition,” she said.
 

Headaches, insomnia among side effects

Weight gain was larger in the placebo group than in the ecopipam group: 17.1% in the ecopipam group and 20.3% of those who got a placebo had a weight gain of more than 7% over the study period.

The most common side effects of the study drug were headache (15.8%), insomnia (14.5%), fatigue (7.9%), and somnolence (7.9%).

A limitation of the study was lack of racial and ethnic diversity, as 93.5% of those in the placebo group and 86.8% in the ecopipam group were White.

Guidelines in North America and Europe agree that behavioral treatments should be the first-line therapy.

Dr. Pawlowski said that although effective medications are needed, she urges focusing on better access to nonmedication treatments “that work for children and adolescents” as children who start taking the medications early may take them for the rest of their lives.

Also, while the research didn’t find weight gain in the ecopipam group, the side effects they did find in the group, including headache and insomnia, “do impact a child’s life,” she noted.

“We also can’t be reassured that over the course of chronic treatment there wouldn’t be movement disorders or metabolic disorders that emerge. Those are side effects or disorders that can emerge surreptitiously over time, and more time than 12 weeks,” she said.

The study was funded by Emalex Biosciences. Dr. Gilbert has received consulting fees from Biogen and PTC therapeutics. Study coauthors disclosed ties with Emalex, Alkermes, and Paragon Biosciences. Dr. Pawlowski reports no relevant financial relationships.

Screening for amblyopia during primary care visits is more cost-effective than screening in school settings and optometric examinations in kindergarten-aged children in Toronto, data suggest.

Because of the low prevalence of amblyopia among young children, a population-based screening program may not warrant the resources required, despite the added health benefits of a universal program, according to the researchers.

“Amblyopia is a public health problem. For this reason, population-wide approaches to detect and treat amblyopia are critical, and approaches such as school screening and mandated optometry exams have been recommended and introduced in some jurisdictions,” study author Afua Oteng Asare, OD, PhD, a research assistant professor at the University of Utah in Salt Lake City, told this news organization. Dr. Asare conducted the study as a PhD student at the University of Toronto.

“With increasing budgeting constraints and limited resources, policymakers are relying more on economic analyses that measure value-for-money to inform their decisions on programming,” she said. “Evidence comparing the cost-effectiveness of vision-testing approaches to the status quo is, however, limited.”

The study was published in JAMA Network Open.
 

Analyzing costs

Despite recommendations for routine testing, a notable percentage of children in Canada and the United States don’t receive an annual vision exam. The percentage is even higher among children from low-income households, said Dr. Asare. Universal screening in schools and mandatory optometric examinations may improve vision care. But the cost-effectiveness of these measures is unknown for certain conditions, such as amblyopia, the prevalence of which ranges between 3% and 5% in young children.

In Ontario, Canada’s largest province with about 3 million children, universal funding for children’s annual comprehensive eye exams and vision screening during well-child visits is provided through provincial health insurance.

In 2018, the Ontario Ministry of Health introduced guidelines for administering vision screening in kindergartens by public health departments. However, school-based screening has been difficult to introduce because of increasing costs and budgeting constraints, the authors wrote. As an alternative to underfunded programs, optometric associations in Canada have advocated for physicians to recommend early childhood optometric exams.

The investigators analyzed the incremental costs and health benefits, from the perspective of the Ontario government, of public health school screening and optometrist-based vision exams, compared with standard vision screening conducted during well-child visits with primary care physicians. They focused on the aim of detecting amblyopia and amblyopia-related risk factors in children between ages 3 and 5 years in Toronto.

For the analysis, the research team simulated a hypothetical cohort of 25,000 children over 15 years in a probabilistic health state transition model. They incorporated various assumptions, including that children had irreversible vision impairment if not diagnosed by an optometrist. In addition, incremental costs were adjusted to favor the standard screening strategy during well-child visits.

In the school-based and primary care scenarios, children with a positive or inconclusive test result were referred to an optometrist for diagnosis and treatment, which would incur the cost of an optometric evaluation. If positive, children were treated with prescription glasses and additional patching for amblyopia.

The research team measured outcomes as incremental quality-adjusted life-years (QALYs), and health utilities were derived from data on adults, because of the lack of data on children under age 6 years with amblyopia or amblyopia risk factors. The researchers also estimated direct costs to the Ontario government, including visits with primary care doctors, optometrists, public health nurses, and contract screeners, as well as prescription glasses for children with vision impairment who receive social assistance. Costs were expressed in Canadian dollars (CAD).

Overall, compared with the primary care screening strategy, the school screening and optometric examination strategies were generally less costly and had more health benefits. The incremental difference in cost was a savings per child of $84.09 CAD for school screening and $74.47 CAD for optometric examinations. Optometric examinations yielded the largest gain in QALYs, compared with the primary care screening strategy, producing average QALYs of 0.0508 per child.

However, only 20% of school screening iterations and 29% of optometric exam iterations were cost-effective, relative to the primary care screening strategy, at a willingness-to-pay threshold of $50,000 CAD per QALY gained. For instance, when comparing optometric exams with primary care screenings, if the cost of vision screening was $11.50 CAD, the incremental cost-effectiveness ratio would be $77.95 CAD per QALY gained.
 

Results ‘make sense’  

“We were initially surprised that the alternative screening programs were not cost-effective, compared to status quo vision screening in well-child visits,” said Dr. Asare. “However, the results make sense, considering the study’s universal approach (screening all children regardless of their vision status) and the study’s consideration only of amblyopia, and not of refractive errors, which are even more common in kindergarten children.”

Dr. Asare noted the lack of current data on the rate of vision screenings conducted in childhood by primary care practitioners and on referrals to eye care providers for children with abnormal screenings. Data on vision health disparities and barriers to accessing vision care in young children also are scarce.

“My ultimate research goal is to create and evaluate evidence-based, cost-effective interventions to be used at the point of care by pediatric primary care providers to improve the quality of vision care for children, especially those from socioeconomically deprived backgrounds,” she said. “The take-home message is that school vision screening and mandated eye exams are excellent programs, but they may not be suitable for all contexts.”

Additional studies are needed to look at the cost-effectiveness of the different screening strategies for other aspects included in childhood vision tests, including binocular vision problems, refractive disorders, myopia, allergies, and rare eye diseases.
 

Significant underestimation?

Susan Leat, PhD, a researcher and professor emerita at the University of Waterloo (Ont.) School of Optometry and Vision Science, said, “This study only considers amblyopia, and not all eye diseases and disorders, which significantly underestimates the cost-effectiveness of optometric eye exams.”

Dr. Leat, who wasn’t involved with this study, has researched pediatric optometry and visual development. She and colleagues are developing new tools to test visual acuity in young children.

“If all disorders were taken into account, then optometric testing would be by far the most cost-effective,” she said. “Optometrists can detect all disorders, including more subtle disorders, which if uncorrected or untreated, can impact a child’s early learning.”

The study authors reported no funding for the study. Dr. Asare and Dr. Leat reported no relevant disclosures.

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

Screening for amblyopia during primary care visits is more cost-effective than screening in school settings and optometric examinations in kindergarten-aged children in Toronto, data suggest.

Because of the low prevalence of amblyopia among young children, a population-based screening program may not warrant the resources required, despite the added health benefits of a universal program, according to the researchers.

“Amblyopia is a public health problem. For this reason, population-wide approaches to detect and treat amblyopia are critical, and approaches such as school screening and mandated optometry exams have been recommended and introduced in some jurisdictions,” study author Afua Oteng Asare, OD, PhD, a research assistant professor at the University of Utah in Salt Lake City, told this news organization. Dr. Asare conducted the study as a PhD student at the University of Toronto.

“With increasing budgeting constraints and limited resources, policymakers are relying more on economic analyses that measure value-for-money to inform their decisions on programming,” she said. “Evidence comparing the cost-effectiveness of vision-testing approaches to the status quo is, however, limited.”

The study was published in JAMA Network Open.
 

Analyzing costs

Despite recommendations for routine testing, a notable percentage of children in Canada and the United States don’t receive an annual vision exam. The percentage is even higher among children from low-income households, said Dr. Asare. Universal screening in schools and mandatory optometric examinations may improve vision care. But the cost-effectiveness of these measures is unknown for certain conditions, such as amblyopia, the prevalence of which ranges between 3% and 5% in young children.

In Ontario, Canada’s largest province with about 3 million children, universal funding for children’s annual comprehensive eye exams and vision screening during well-child visits is provided through provincial health insurance.

In 2018, the Ontario Ministry of Health introduced guidelines for administering vision screening in kindergartens by public health departments. However, school-based screening has been difficult to introduce because of increasing costs and budgeting constraints, the authors wrote. As an alternative to underfunded programs, optometric associations in Canada have advocated for physicians to recommend early childhood optometric exams.

The investigators analyzed the incremental costs and health benefits, from the perspective of the Ontario government, of public health school screening and optometrist-based vision exams, compared with standard vision screening conducted during well-child visits with primary care physicians. They focused on the aim of detecting amblyopia and amblyopia-related risk factors in children between ages 3 and 5 years in Toronto.

For the analysis, the research team simulated a hypothetical cohort of 25,000 children over 15 years in a probabilistic health state transition model. They incorporated various assumptions, including that children had irreversible vision impairment if not diagnosed by an optometrist. In addition, incremental costs were adjusted to favor the standard screening strategy during well-child visits.

In the school-based and primary care scenarios, children with a positive or inconclusive test result were referred to an optometrist for diagnosis and treatment, which would incur the cost of an optometric evaluation. If positive, children were treated with prescription glasses and additional patching for amblyopia.

The research team measured outcomes as incremental quality-adjusted life-years (QALYs), and health utilities were derived from data on adults, because of the lack of data on children under age 6 years with amblyopia or amblyopia risk factors. The researchers also estimated direct costs to the Ontario government, including visits with primary care doctors, optometrists, public health nurses, and contract screeners, as well as prescription glasses for children with vision impairment who receive social assistance. Costs were expressed in Canadian dollars (CAD).

Overall, compared with the primary care screening strategy, the school screening and optometric examination strategies were generally less costly and had more health benefits. The incremental difference in cost was a savings per child of $84.09 CAD for school screening and $74.47 CAD for optometric examinations. Optometric examinations yielded the largest gain in QALYs, compared with the primary care screening strategy, producing average QALYs of 0.0508 per child.

However, only 20% of school screening iterations and 29% of optometric exam iterations were cost-effective, relative to the primary care screening strategy, at a willingness-to-pay threshold of $50,000 CAD per QALY gained. For instance, when comparing optometric exams with primary care screenings, if the cost of vision screening was $11.50 CAD, the incremental cost-effectiveness ratio would be $77.95 CAD per QALY gained.
 

Results ‘make sense’  

“We were initially surprised that the alternative screening programs were not cost-effective, compared to status quo vision screening in well-child visits,” said Dr. Asare. “However, the results make sense, considering the study’s universal approach (screening all children regardless of their vision status) and the study’s consideration only of amblyopia, and not of refractive errors, which are even more common in kindergarten children.”

Dr. Asare noted the lack of current data on the rate of vision screenings conducted in childhood by primary care practitioners and on referrals to eye care providers for children with abnormal screenings. Data on vision health disparities and barriers to accessing vision care in young children also are scarce.

“My ultimate research goal is to create and evaluate evidence-based, cost-effective interventions to be used at the point of care by pediatric primary care providers to improve the quality of vision care for children, especially those from socioeconomically deprived backgrounds,” she said. “The take-home message is that school vision screening and mandated eye exams are excellent programs, but they may not be suitable for all contexts.”

Additional studies are needed to look at the cost-effectiveness of the different screening strategies for other aspects included in childhood vision tests, including binocular vision problems, refractive disorders, myopia, allergies, and rare eye diseases.
 

Significant underestimation?

Susan Leat, PhD, a researcher and professor emerita at the University of Waterloo (Ont.) School of Optometry and Vision Science, said, “This study only considers amblyopia, and not all eye diseases and disorders, which significantly underestimates the cost-effectiveness of optometric eye exams.”

Dr. Leat, who wasn’t involved with this study, has researched pediatric optometry and visual development. She and colleagues are developing new tools to test visual acuity in young children.

“If all disorders were taken into account, then optometric testing would be by far the most cost-effective,” she said. “Optometrists can detect all disorders, including more subtle disorders, which if uncorrected or untreated, can impact a child’s early learning.”

The study authors reported no funding for the study. Dr. Asare and Dr. Leat reported no relevant disclosures.

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

Screening for amblyopia during primary care visits is more cost-effective than screening in school settings and optometric examinations in kindergarten-aged children in Toronto, data suggest.

Because of the low prevalence of amblyopia among young children, a population-based screening program may not warrant the resources required, despite the added health benefits of a universal program, according to the researchers.

“Amblyopia is a public health problem. For this reason, population-wide approaches to detect and treat amblyopia are critical, and approaches such as school screening and mandated optometry exams have been recommended and introduced in some jurisdictions,” study author Afua Oteng Asare, OD, PhD, a research assistant professor at the University of Utah in Salt Lake City, told this news organization. Dr. Asare conducted the study as a PhD student at the University of Toronto.

“With increasing budgeting constraints and limited resources, policymakers are relying more on economic analyses that measure value-for-money to inform their decisions on programming,” she said. “Evidence comparing the cost-effectiveness of vision-testing approaches to the status quo is, however, limited.”

The study was published in JAMA Network Open.
 

Analyzing costs

Despite recommendations for routine testing, a notable percentage of children in Canada and the United States don’t receive an annual vision exam. The percentage is even higher among children from low-income households, said Dr. Asare. Universal screening in schools and mandatory optometric examinations may improve vision care. But the cost-effectiveness of these measures is unknown for certain conditions, such as amblyopia, the prevalence of which ranges between 3% and 5% in young children.

In Ontario, Canada’s largest province with about 3 million children, universal funding for children’s annual comprehensive eye exams and vision screening during well-child visits is provided through provincial health insurance.

In 2018, the Ontario Ministry of Health introduced guidelines for administering vision screening in kindergartens by public health departments. However, school-based screening has been difficult to introduce because of increasing costs and budgeting constraints, the authors wrote. As an alternative to underfunded programs, optometric associations in Canada have advocated for physicians to recommend early childhood optometric exams.

The investigators analyzed the incremental costs and health benefits, from the perspective of the Ontario government, of public health school screening and optometrist-based vision exams, compared with standard vision screening conducted during well-child visits with primary care physicians. They focused on the aim of detecting amblyopia and amblyopia-related risk factors in children between ages 3 and 5 years in Toronto.

For the analysis, the research team simulated a hypothetical cohort of 25,000 children over 15 years in a probabilistic health state transition model. They incorporated various assumptions, including that children had irreversible vision impairment if not diagnosed by an optometrist. In addition, incremental costs were adjusted to favor the standard screening strategy during well-child visits.

In the school-based and primary care scenarios, children with a positive or inconclusive test result were referred to an optometrist for diagnosis and treatment, which would incur the cost of an optometric evaluation. If positive, children were treated with prescription glasses and additional patching for amblyopia.

The research team measured outcomes as incremental quality-adjusted life-years (QALYs), and health utilities were derived from data on adults, because of the lack of data on children under age 6 years with amblyopia or amblyopia risk factors. The researchers also estimated direct costs to the Ontario government, including visits with primary care doctors, optometrists, public health nurses, and contract screeners, as well as prescription glasses for children with vision impairment who receive social assistance. Costs were expressed in Canadian dollars (CAD).

Overall, compared with the primary care screening strategy, the school screening and optometric examination strategies were generally less costly and had more health benefits. The incremental difference in cost was a savings per child of $84.09 CAD for school screening and $74.47 CAD for optometric examinations. Optometric examinations yielded the largest gain in QALYs, compared with the primary care screening strategy, producing average QALYs of 0.0508 per child.

However, only 20% of school screening iterations and 29% of optometric exam iterations were cost-effective, relative to the primary care screening strategy, at a willingness-to-pay threshold of $50,000 CAD per QALY gained. For instance, when comparing optometric exams with primary care screenings, if the cost of vision screening was $11.50 CAD, the incremental cost-effectiveness ratio would be $77.95 CAD per QALY gained.
 

Results ‘make sense’  

“We were initially surprised that the alternative screening programs were not cost-effective, compared to status quo vision screening in well-child visits,” said Dr. Asare. “However, the results make sense, considering the study’s universal approach (screening all children regardless of their vision status) and the study’s consideration only of amblyopia, and not of refractive errors, which are even more common in kindergarten children.”

Dr. Asare noted the lack of current data on the rate of vision screenings conducted in childhood by primary care practitioners and on referrals to eye care providers for children with abnormal screenings. Data on vision health disparities and barriers to accessing vision care in young children also are scarce.

“My ultimate research goal is to create and evaluate evidence-based, cost-effective interventions to be used at the point of care by pediatric primary care providers to improve the quality of vision care for children, especially those from socioeconomically deprived backgrounds,” she said. “The take-home message is that school vision screening and mandated eye exams are excellent programs, but they may not be suitable for all contexts.”

Additional studies are needed to look at the cost-effectiveness of the different screening strategies for other aspects included in childhood vision tests, including binocular vision problems, refractive disorders, myopia, allergies, and rare eye diseases.
 

Significant underestimation?

Susan Leat, PhD, a researcher and professor emerita at the University of Waterloo (Ont.) School of Optometry and Vision Science, said, “This study only considers amblyopia, and not all eye diseases and disorders, which significantly underestimates the cost-effectiveness of optometric eye exams.”

Dr. Leat, who wasn’t involved with this study, has researched pediatric optometry and visual development. She and colleagues are developing new tools to test visual acuity in young children.

“If all disorders were taken into account, then optometric testing would be by far the most cost-effective,” she said. “Optometrists can detect all disorders, including more subtle disorders, which if uncorrected or untreated, can impact a child’s early learning.”

The study authors reported no funding for the study. Dr. Asare and Dr. Leat reported no relevant disclosures.

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

Children who were exposed in utero to maternal cancer and treatment do not appear to have any long-term health consequences as a result of this exposure, a nationwide Danish study suggests.

The study evaluated live-born children between January 1978 and December 2018 whose mothers were diagnosed with cancer during pregnancy. Compared with unexposed fetuses, children exposed in utero had no higher overall mortality and no increased risk of congenital malformations.

Researchers also determined that exposure to chemotherapy was not associated with somatic diseases and congenital malformations when compared with in utero exposure to maternal cancer without chemotherapy.

“These findings suggest that fetal exposure to maternal cancer and treatment did not have implications for the long-term somatic and psychiatric health of the children, which is reassuring for the affected families and their health care providers,” the researchers commented.

The paper was published online in the Journal of Clinical Oncology.

Approached for comment, Katherine Van Loon, MD, MPH, director of the Global Cancer Program at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, said the results offer “promising news.”

“In the balance between administering needed oncologic therapy to save a mother’s life versus considering potential risks to the fetus, this data is reassuring that there is not an increased risk of catastrophic outcomes for the fetus,” Dr. Van Loon said. She noted, however, that the exposed children were not prospectively evaluated for adverse outcomes, which may have been more subtle that this study could detect.

The authors used data from the Danish Civil Registration System and Danish Medical Birth Register. They found that of 2,526,163 live-born children, 690 (0.03%) were exposed to maternal cancer in utero. Children born to mothers younger than 15 years or older than 54 years and children with an outcome diagnosis were excluded from the study.

Researchers found that children exposed to maternal cancer in utero did not demonstrate a higher overall mortality than the unexposed reference group; adjusted hazard ratio, 0.8 (95% confidence interval, 0.4-1.5). There was also no excess of congenital malformations (aHR, 1.0 [95% CI, 0.8-1.2]). In addition, there were no excesses of puberty disturbances or respiratory, cardiovascular, urinary tract, or neurologic disease.

Researchers also conducted a subgroup analysis on in utero exposure to chemotherapy, which involved 1,053,109 children born after 2002. There were 378 (0.03%) children exposed to maternal cancer in utero, and 42 (12.5%) who were exposed to chemotherapy. Chemotherapy was given during the second trimester in 73.8% of the mothers and during the third trimester in 26.2%.

No deaths or events of cancer, autism spectrum disorder, ADHD, hearing loss, or suppressed myelopoiesis were identified during follow-up of the 42 children exposed to chemotherapy in utero.

Dr. Van Loon said many cancer treatments are safe during pregnancy but added that every situation is nuanced with a number of variables to consider.

“All treatment decisions must take into account the diagnosis and prognosis of the mother, the gestational age of the fetus, and the potential teratogenic effects of the proposed treatments,” she said.

The study was supported by grants from the Research Fund of Rigshospitalet, Copenhagen University Hospital, the Novo Nordisk Foundation, Johannes Clemmesen Research Foundation, Helsefonden, Holm Memorial Foundation, and the Danish Cancer Research Foundation. Researcher disclosures are listed in the study paper.
 

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

Children who were exposed in utero to maternal cancer and treatment do not appear to have any long-term health consequences as a result of this exposure, a nationwide Danish study suggests.

The study evaluated live-born children between January 1978 and December 2018 whose mothers were diagnosed with cancer during pregnancy. Compared with unexposed fetuses, children exposed in utero had no higher overall mortality and no increased risk of congenital malformations.

Researchers also determined that exposure to chemotherapy was not associated with somatic diseases and congenital malformations when compared with in utero exposure to maternal cancer without chemotherapy.

“These findings suggest that fetal exposure to maternal cancer and treatment did not have implications for the long-term somatic and psychiatric health of the children, which is reassuring for the affected families and their health care providers,” the researchers commented.

The paper was published online in the Journal of Clinical Oncology.

Approached for comment, Katherine Van Loon, MD, MPH, director of the Global Cancer Program at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, said the results offer “promising news.”

“In the balance between administering needed oncologic therapy to save a mother’s life versus considering potential risks to the fetus, this data is reassuring that there is not an increased risk of catastrophic outcomes for the fetus,” Dr. Van Loon said. She noted, however, that the exposed children were not prospectively evaluated for adverse outcomes, which may have been more subtle that this study could detect.

The authors used data from the Danish Civil Registration System and Danish Medical Birth Register. They found that of 2,526,163 live-born children, 690 (0.03%) were exposed to maternal cancer in utero. Children born to mothers younger than 15 years or older than 54 years and children with an outcome diagnosis were excluded from the study.

Researchers found that children exposed to maternal cancer in utero did not demonstrate a higher overall mortality than the unexposed reference group; adjusted hazard ratio, 0.8 (95% confidence interval, 0.4-1.5). There was also no excess of congenital malformations (aHR, 1.0 [95% CI, 0.8-1.2]). In addition, there were no excesses of puberty disturbances or respiratory, cardiovascular, urinary tract, or neurologic disease.

Researchers also conducted a subgroup analysis on in utero exposure to chemotherapy, which involved 1,053,109 children born after 2002. There were 378 (0.03%) children exposed to maternal cancer in utero, and 42 (12.5%) who were exposed to chemotherapy. Chemotherapy was given during the second trimester in 73.8% of the mothers and during the third trimester in 26.2%.

No deaths or events of cancer, autism spectrum disorder, ADHD, hearing loss, or suppressed myelopoiesis were identified during follow-up of the 42 children exposed to chemotherapy in utero.

Dr. Van Loon said many cancer treatments are safe during pregnancy but added that every situation is nuanced with a number of variables to consider.

“All treatment decisions must take into account the diagnosis and prognosis of the mother, the gestational age of the fetus, and the potential teratogenic effects of the proposed treatments,” she said.

The study was supported by grants from the Research Fund of Rigshospitalet, Copenhagen University Hospital, the Novo Nordisk Foundation, Johannes Clemmesen Research Foundation, Helsefonden, Holm Memorial Foundation, and the Danish Cancer Research Foundation. Researcher disclosures are listed in the study paper.
 

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

Children who were exposed in utero to maternal cancer and treatment do not appear to have any long-term health consequences as a result of this exposure, a nationwide Danish study suggests.

The study evaluated live-born children between January 1978 and December 2018 whose mothers were diagnosed with cancer during pregnancy. Compared with unexposed fetuses, children exposed in utero had no higher overall mortality and no increased risk of congenital malformations.

Researchers also determined that exposure to chemotherapy was not associated with somatic diseases and congenital malformations when compared with in utero exposure to maternal cancer without chemotherapy.

“These findings suggest that fetal exposure to maternal cancer and treatment did not have implications for the long-term somatic and psychiatric health of the children, which is reassuring for the affected families and their health care providers,” the researchers commented.

The paper was published online in the Journal of Clinical Oncology.

Approached for comment, Katherine Van Loon, MD, MPH, director of the Global Cancer Program at the University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center, said the results offer “promising news.”

“In the balance between administering needed oncologic therapy to save a mother’s life versus considering potential risks to the fetus, this data is reassuring that there is not an increased risk of catastrophic outcomes for the fetus,” Dr. Van Loon said. She noted, however, that the exposed children were not prospectively evaluated for adverse outcomes, which may have been more subtle that this study could detect.

The authors used data from the Danish Civil Registration System and Danish Medical Birth Register. They found that of 2,526,163 live-born children, 690 (0.03%) were exposed to maternal cancer in utero. Children born to mothers younger than 15 years or older than 54 years and children with an outcome diagnosis were excluded from the study.

Researchers found that children exposed to maternal cancer in utero did not demonstrate a higher overall mortality than the unexposed reference group; adjusted hazard ratio, 0.8 (95% confidence interval, 0.4-1.5). There was also no excess of congenital malformations (aHR, 1.0 [95% CI, 0.8-1.2]). In addition, there were no excesses of puberty disturbances or respiratory, cardiovascular, urinary tract, or neurologic disease.

Researchers also conducted a subgroup analysis on in utero exposure to chemotherapy, which involved 1,053,109 children born after 2002. There were 378 (0.03%) children exposed to maternal cancer in utero, and 42 (12.5%) who were exposed to chemotherapy. Chemotherapy was given during the second trimester in 73.8% of the mothers and during the third trimester in 26.2%.

No deaths or events of cancer, autism spectrum disorder, ADHD, hearing loss, or suppressed myelopoiesis were identified during follow-up of the 42 children exposed to chemotherapy in utero.

Dr. Van Loon said many cancer treatments are safe during pregnancy but added that every situation is nuanced with a number of variables to consider.

“All treatment decisions must take into account the diagnosis and prognosis of the mother, the gestational age of the fetus, and the potential teratogenic effects of the proposed treatments,” she said.

The study was supported by grants from the Research Fund of Rigshospitalet, Copenhagen University Hospital, the Novo Nordisk Foundation, Johannes Clemmesen Research Foundation, Helsefonden, Holm Memorial Foundation, and the Danish Cancer Research Foundation. Researcher disclosures are listed in the study paper.
 

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

The assessment and diagnosis of bipolar disorder in youth has a complicated and controversial history. I recall from my child and adolescent fellowship training that there was a thinly veiled faculty argument about the diagnosis itself with strong opinions on each side. To revisit this quandary, I reviewed the most up-to-date literature and outlined a case-based approach to the initial screening assessment. Certainly, the assessment by a child and adolescent psychiatrist would be the standard for diagnosis, but we do know that the pediatrician’s office may be the first setting for a child and parent to present with mood symptoms and concerns about bipolar disorder. What can you do to address this adolescent, Carrie, and her mother’s concerns?

Case

Carrie is a 17-year-old girl who has struggled through her childhood and adolescence with anxious and depressive symptoms which have ebbed and flowed with major life stressors, including her parent’s divorce. She has tried cognitive-behavioral therapy and selective serotonin reuptake inhibitors, but the SSRI seemed to cause feelings of anxiousness and agitation, so she stopped it within weeks.

Her mother presents to you concerned that Carrie has had a more persistently irritable mood toward her, often just wanting to be with her friends or otherwise isolate in her room when home to study.

Most concerning to her mother is that Carrie, as a straight A student, has also developed a pattern of staying up all night to study for tests and then “crashes” and sleeps through the weekend, avoiding her mother and only brightening with her friends.

To complicate matters, Carrie’s biological father had type 1 bipolar disorder and an addiction. Her mother comes to you with an initially nonparticipatory Carrie in tow and says: “My former husband began his manic episodes with a lack of sleep and Carrie is so irritable towards me. I feel like I am walking on eggshells all the time. Could this be bipolar disorder?”
 

Case discussion

First, it’s always useful to frame a visit stating that you will spend some time with the patient and some time with both the patient and parent. Emphasizing confidentiality about issues such as drug use, which can be comorbid with mood symptoms and go undetected in high-achieving students such as Carrie, is also important. Further emphasizing that information will not be reflexively shared with the parent unless the child presents a danger to herself or others is also paramount to receive an honest report of symptoms.

Second, there are many signs and symptoms of bipolar disorder that naturally overlap with other conditions such as distractibility with attention-deficit/hyperactivity disorder, or irritability in either a unipolar depression or disruptive mood dysregulation disorder.1 You are looking for an episodic (not chronic) course of symptoms with episodes that last over 5 days for hypomania and over the course of weeks for mania all while meeting all the classic criteria for bipolar disorder.

Note that the broadening of diagnostic criteria has been thought to contribute to an inflated sense of prevalence. The actual expert estimate of prevalence is around 0.8%-1.8% in pediatric populations, although there is a large published range depending on whether the criteria are modified or not.2 Use of the unmodified criteria from the DSM-5 is the recommended approach. Bipolar disorder is exceedingly rare in prepubertal children, and it would be more common for prodromal symptoms such as Carrie’s to emerge and escalate over the teenage years, culminating in a clearer diagnosis in the later teens or 20s.3

In my screening questions, I find the idea of an “infatiguable state” is the most pathognomonic one in considering mania in bipolar disorder.4 Carrie’s “crashing” after nights of studying shows that she clearly fatigues. Patients with bipolar disorder within episodes of hypomania or mania have a seismic shift in perceived energy and a matching lack of ability to sleep that can affect their thought processes, speech, and decision-making. At first blush, Carrie’s history does not indicate current symptoms of bipolar disorder.3
 

Case, continued

When you meet with Carrie alone she shares that she has been experimenting with prescribed stimulants from her older college-aged brother in order to study and ace her tests. She is also experimenting with alcohol and marijuana with her friends. You provide her the CRAFFT tool to deepen your screening of this issue.5

With her mother, you administer the Parent General Behavior Inventory6 and the and the Child Mania Rating Scale7. From these scales, you note that the irritability is more specific to Carrie’s family than pan-present in school and with friends. Her lack of sleep occurs at high-pressure and discreet times.

At this point, you reassure Carrie and her mother that Carrie does not present with symptoms of bipolar disorder but that certainly you will continue screening assessments over time, as they are a good means to track symptoms. You also recommend that Carrie consider mood tracking so she can develop insights into her mood and its relationship to sleep and other events as she prepares for college.8
 

Case discussion, continued

The strongest risk factor for bipolar disorder in youth is family history (specifically a parent) with bipolar disorder).9 If there is the chance to explore the parent’s illness with open-ended questions, you will want to hear about the parent’s age of symptom onset, course of treatment, any hospitalizations, and stabilizing medications because this has prognostic power for your patient. It is important to ensure that the parent indeed has a diagnosis of bipolar disorder and that it is not just being used colloquially to characterize an adult who has labile moods from hour to hour or day to day. This would give undue anticipatory anxiety to a youth about their risk, which is up to 8- to 10-fold greater with a parent with bipolar disorder.9

Even with a strong family history, we do not often see bipolar disorder emerge in prepubertal children.10,11 There may be still concerning prodromal symptoms in which a diagnosis of unipolar depression with more irritable features and mood lability seems more commonly complicated by substance use, as with Carrie.

Activation with an SSRI, as in Carrie’s case, even if not resulting in full mania or hypomania, can also be a soft sign of the serotonergic sensitivity present in bipolar disorder. However, if there are not additional symptoms of bipolar disorder and you are concerned based on family history alone, you do not want to withhold antidepressant treatment because fear of risk. You would want to consider a “dose low and go slow” titration process with more frequent monitoring.

A diagnostic interview with a child and adolescent psychiatrist and administration of scales such as the Young Mania Rating Scale and the Modified Child Depression Rating Scale are the standard means to assess for bipolar symptoms.12 Considering the dearth of child psychiatrists nationally, it would be useful to improve one’s screening in primary care so as to not inadvertently “refer out” all patients for whom mood dysregulation is a concern.

There is also a more expanded tool that includes several scales integrated with clinical information (parent’s age of mood disorder onset, child’s age) which can culminate in a risk score.13

Lastly, I provide my patients with a handout of the Young Mania Rating Scale to take home as a reference and to complete before our next visit.14

You can repeat scales to monitor for more striking bipolar disorder signs and symptoms that emerge over the course of one’s longitudinal treatment of a pediatric patient. This can be an ongoing, episodic assessment since the emergence of bipolar disorder has been shown to range from the teenage years and beyond into the 20s and sometimes 30s.
 

Case, continued

Carrie presents to you again while in her first semester of college at the age of 19. She is taking a leave of absence after she began experimenting with cocaine at college and had a manic episode characterized by a lack of sleep without fatigue, persistent unabating energy, rapid and pressured speech, and ultimately, concern from her college friends. She was admitted to a psychiatric unit and stabilized on a second-generation antipsychotic, risperidone, which has solid evidence for mania, but she and you are now concerned about longer-term metabolic effects.15,16

You discuss monitoring her lipid profile and hemoglobin A1c, in addition to weight gain and waist circumference. She has connected with a therapist and psychiatrist through the college counseling center and hopes to return next semester with a fresh start and commitment to sobriety and social rhythms therapy known to be helpful for patients with bipolar disorder.17

While it is challenging to manage a chronic illness at her age, she feels hopeful that she can make better choices for her overall health with your support and the support of her family and mental health team.

Dr. Pawlowski is a child and adolescent consulting psychiatrist. She is a division chief at the University of Vermont Medical Center, Burlington, where she focuses on primary care mental health integration within primary care pediatrics, internal medicine, and family medicine.
 

References

1. Bipolar Disord. 2016 Jan 9 doi: 10.1111/bdi.12358.

2. Int J Bipolar Disord. 2021 Jun 25. doi: 10.1186/s40345-021-00225-5.

3. Am J Psychiatry. 2018 Dec 11. doi: 10.1176/appi.ajp.2018.18040461.

4. DSM-5 Changes: Implications for Child Serious Emotional Disturbance. Rockville, Md.: Substance Abuse and Mental Health Services Administration, 2016.

5. The CRAFFT tool.

6. General Behavior Inventory. Parent Version (P-GBI) Short Form – H/B (Revised Version, 2008).

7. Child Mania Rating Scale, Parent Version (CMRS-P).

8. https://www.moodtracker.com.

9. J Clin Psychiatry. 2000 Sep. doi: 10.4088/jcp.v61n0906.

10. Int J Bipolar Disord. 2020 Apr 20. doi: 10.1186/s40345-020-00185-2.

11. Int J Bipolar Disord. 2021 Jun 25. doi: 10.1186/s40345-021-00225-5.

12. Bipolar Disord. 2017 Sep 25. doi: 10.1111/bdi.12556.

13. www.cabsresearch.pitt.edu/bpriskcalculator/.

14. Parent Version of the Young Mania Rating Scale (PYMRS).

15. Arch Gen Psychiatry. 2012 Jan 2. doi: 10.1001/archgenpsychiatry.2011.1508.

16. The Carlat Child Psychiatry Report. “Bipolar Disorder” Newburyport, Mass.: Carlat Publishing, 2012.

17. https://www.ipsrt.org/.

The assessment and diagnosis of bipolar disorder in youth has a complicated and controversial history. I recall from my child and adolescent fellowship training that there was a thinly veiled faculty argument about the diagnosis itself with strong opinions on each side. To revisit this quandary, I reviewed the most up-to-date literature and outlined a case-based approach to the initial screening assessment. Certainly, the assessment by a child and adolescent psychiatrist would be the standard for diagnosis, but we do know that the pediatrician’s office may be the first setting for a child and parent to present with mood symptoms and concerns about bipolar disorder. What can you do to address this adolescent, Carrie, and her mother’s concerns?

Case

Carrie is a 17-year-old girl who has struggled through her childhood and adolescence with anxious and depressive symptoms which have ebbed and flowed with major life stressors, including her parent’s divorce. She has tried cognitive-behavioral therapy and selective serotonin reuptake inhibitors, but the SSRI seemed to cause feelings of anxiousness and agitation, so she stopped it within weeks.

Her mother presents to you concerned that Carrie has had a more persistently irritable mood toward her, often just wanting to be with her friends or otherwise isolate in her room when home to study.

Most concerning to her mother is that Carrie, as a straight A student, has also developed a pattern of staying up all night to study for tests and then “crashes” and sleeps through the weekend, avoiding her mother and only brightening with her friends.

To complicate matters, Carrie’s biological father had type 1 bipolar disorder and an addiction. Her mother comes to you with an initially nonparticipatory Carrie in tow and says: “My former husband began his manic episodes with a lack of sleep and Carrie is so irritable towards me. I feel like I am walking on eggshells all the time. Could this be bipolar disorder?”
 

Case discussion

First, it’s always useful to frame a visit stating that you will spend some time with the patient and some time with both the patient and parent. Emphasizing confidentiality about issues such as drug use, which can be comorbid with mood symptoms and go undetected in high-achieving students such as Carrie, is also important. Further emphasizing that information will not be reflexively shared with the parent unless the child presents a danger to herself or others is also paramount to receive an honest report of symptoms.

Second, there are many signs and symptoms of bipolar disorder that naturally overlap with other conditions such as distractibility with attention-deficit/hyperactivity disorder, or irritability in either a unipolar depression or disruptive mood dysregulation disorder.1 You are looking for an episodic (not chronic) course of symptoms with episodes that last over 5 days for hypomania and over the course of weeks for mania all while meeting all the classic criteria for bipolar disorder.

Note that the broadening of diagnostic criteria has been thought to contribute to an inflated sense of prevalence. The actual expert estimate of prevalence is around 0.8%-1.8% in pediatric populations, although there is a large published range depending on whether the criteria are modified or not.2 Use of the unmodified criteria from the DSM-5 is the recommended approach. Bipolar disorder is exceedingly rare in prepubertal children, and it would be more common for prodromal symptoms such as Carrie’s to emerge and escalate over the teenage years, culminating in a clearer diagnosis in the later teens or 20s.3

In my screening questions, I find the idea of an “infatiguable state” is the most pathognomonic one in considering mania in bipolar disorder.4 Carrie’s “crashing” after nights of studying shows that she clearly fatigues. Patients with bipolar disorder within episodes of hypomania or mania have a seismic shift in perceived energy and a matching lack of ability to sleep that can affect their thought processes, speech, and decision-making. At first blush, Carrie’s history does not indicate current symptoms of bipolar disorder.3
 

Case, continued

When you meet with Carrie alone she shares that she has been experimenting with prescribed stimulants from her older college-aged brother in order to study and ace her tests. She is also experimenting with alcohol and marijuana with her friends. You provide her the CRAFFT tool to deepen your screening of this issue.5

With her mother, you administer the Parent General Behavior Inventory6 and the and the Child Mania Rating Scale7. From these scales, you note that the irritability is more specific to Carrie’s family than pan-present in school and with friends. Her lack of sleep occurs at high-pressure and discreet times.

At this point, you reassure Carrie and her mother that Carrie does not present with symptoms of bipolar disorder but that certainly you will continue screening assessments over time, as they are a good means to track symptoms. You also recommend that Carrie consider mood tracking so she can develop insights into her mood and its relationship to sleep and other events as she prepares for college.8
 

Case discussion, continued

The strongest risk factor for bipolar disorder in youth is family history (specifically a parent) with bipolar disorder).9 If there is the chance to explore the parent’s illness with open-ended questions, you will want to hear about the parent’s age of symptom onset, course of treatment, any hospitalizations, and stabilizing medications because this has prognostic power for your patient. It is important to ensure that the parent indeed has a diagnosis of bipolar disorder and that it is not just being used colloquially to characterize an adult who has labile moods from hour to hour or day to day. This would give undue anticipatory anxiety to a youth about their risk, which is up to 8- to 10-fold greater with a parent with bipolar disorder.9

Even with a strong family history, we do not often see bipolar disorder emerge in prepubertal children.10,11 There may be still concerning prodromal symptoms in which a diagnosis of unipolar depression with more irritable features and mood lability seems more commonly complicated by substance use, as with Carrie.

Activation with an SSRI, as in Carrie’s case, even if not resulting in full mania or hypomania, can also be a soft sign of the serotonergic sensitivity present in bipolar disorder. However, if there are not additional symptoms of bipolar disorder and you are concerned based on family history alone, you do not want to withhold antidepressant treatment because fear of risk. You would want to consider a “dose low and go slow” titration process with more frequent monitoring.

A diagnostic interview with a child and adolescent psychiatrist and administration of scales such as the Young Mania Rating Scale and the Modified Child Depression Rating Scale are the standard means to assess for bipolar symptoms.12 Considering the dearth of child psychiatrists nationally, it would be useful to improve one’s screening in primary care so as to not inadvertently “refer out” all patients for whom mood dysregulation is a concern.

There is also a more expanded tool that includes several scales integrated with clinical information (parent’s age of mood disorder onset, child’s age) which can culminate in a risk score.13

Lastly, I provide my patients with a handout of the Young Mania Rating Scale to take home as a reference and to complete before our next visit.14

You can repeat scales to monitor for more striking bipolar disorder signs and symptoms that emerge over the course of one’s longitudinal treatment of a pediatric patient. This can be an ongoing, episodic assessment since the emergence of bipolar disorder has been shown to range from the teenage years and beyond into the 20s and sometimes 30s.
 

Case, continued

Carrie presents to you again while in her first semester of college at the age of 19. She is taking a leave of absence after she began experimenting with cocaine at college and had a manic episode characterized by a lack of sleep without fatigue, persistent unabating energy, rapid and pressured speech, and ultimately, concern from her college friends. She was admitted to a psychiatric unit and stabilized on a second-generation antipsychotic, risperidone, which has solid evidence for mania, but she and you are now concerned about longer-term metabolic effects.15,16

You discuss monitoring her lipid profile and hemoglobin A1c, in addition to weight gain and waist circumference. She has connected with a therapist and psychiatrist through the college counseling center and hopes to return next semester with a fresh start and commitment to sobriety and social rhythms therapy known to be helpful for patients with bipolar disorder.17

While it is challenging to manage a chronic illness at her age, she feels hopeful that she can make better choices for her overall health with your support and the support of her family and mental health team.

Dr. Pawlowski is a child and adolescent consulting psychiatrist. She is a division chief at the University of Vermont Medical Center, Burlington, where she focuses on primary care mental health integration within primary care pediatrics, internal medicine, and family medicine.
 

References

1. Bipolar Disord. 2016 Jan 9 doi: 10.1111/bdi.12358.

2. Int J Bipolar Disord. 2021 Jun 25. doi: 10.1186/s40345-021-00225-5.

3. Am J Psychiatry. 2018 Dec 11. doi: 10.1176/appi.ajp.2018.18040461.

4. DSM-5 Changes: Implications for Child Serious Emotional Disturbance. Rockville, Md.: Substance Abuse and Mental Health Services Administration, 2016.

5. The CRAFFT tool.

6. General Behavior Inventory. Parent Version (P-GBI) Short Form – H/B (Revised Version, 2008).

7. Child Mania Rating Scale, Parent Version (CMRS-P).

8. https://www.moodtracker.com.

9. J Clin Psychiatry. 2000 Sep. doi: 10.4088/jcp.v61n0906.

10. Int J Bipolar Disord. 2020 Apr 20. doi: 10.1186/s40345-020-00185-2.

11. Int J Bipolar Disord. 2021 Jun 25. doi: 10.1186/s40345-021-00225-5.

12. Bipolar Disord. 2017 Sep 25. doi: 10.1111/bdi.12556.

13. www.cabsresearch.pitt.edu/bpriskcalculator/.

14. Parent Version of the Young Mania Rating Scale (PYMRS).

15. Arch Gen Psychiatry. 2012 Jan 2. doi: 10.1001/archgenpsychiatry.2011.1508.

16. The Carlat Child Psychiatry Report. “Bipolar Disorder” Newburyport, Mass.: Carlat Publishing, 2012.

17. https://www.ipsrt.org/.

The assessment and diagnosis of bipolar disorder in youth has a complicated and controversial history. I recall from my child and adolescent fellowship training that there was a thinly veiled faculty argument about the diagnosis itself with strong opinions on each side. To revisit this quandary, I reviewed the most up-to-date literature and outlined a case-based approach to the initial screening assessment. Certainly, the assessment by a child and adolescent psychiatrist would be the standard for diagnosis, but we do know that the pediatrician’s office may be the first setting for a child and parent to present with mood symptoms and concerns about bipolar disorder. What can you do to address this adolescent, Carrie, and her mother’s concerns?

Case

Carrie is a 17-year-old girl who has struggled through her childhood and adolescence with anxious and depressive symptoms which have ebbed and flowed with major life stressors, including her parent’s divorce. She has tried cognitive-behavioral therapy and selective serotonin reuptake inhibitors, but the SSRI seemed to cause feelings of anxiousness and agitation, so she stopped it within weeks.

Her mother presents to you concerned that Carrie has had a more persistently irritable mood toward her, often just wanting to be with her friends or otherwise isolate in her room when home to study.

Most concerning to her mother is that Carrie, as a straight A student, has also developed a pattern of staying up all night to study for tests and then “crashes” and sleeps through the weekend, avoiding her mother and only brightening with her friends.

To complicate matters, Carrie’s biological father had type 1 bipolar disorder and an addiction. Her mother comes to you with an initially nonparticipatory Carrie in tow and says: “My former husband began his manic episodes with a lack of sleep and Carrie is so irritable towards me. I feel like I am walking on eggshells all the time. Could this be bipolar disorder?”
 

Case discussion

First, it’s always useful to frame a visit stating that you will spend some time with the patient and some time with both the patient and parent. Emphasizing confidentiality about issues such as drug use, which can be comorbid with mood symptoms and go undetected in high-achieving students such as Carrie, is also important. Further emphasizing that information will not be reflexively shared with the parent unless the child presents a danger to herself or others is also paramount to receive an honest report of symptoms.

Second, there are many signs and symptoms of bipolar disorder that naturally overlap with other conditions such as distractibility with attention-deficit/hyperactivity disorder, or irritability in either a unipolar depression or disruptive mood dysregulation disorder.1 You are looking for an episodic (not chronic) course of symptoms with episodes that last over 5 days for hypomania and over the course of weeks for mania all while meeting all the classic criteria for bipolar disorder.

Note that the broadening of diagnostic criteria has been thought to contribute to an inflated sense of prevalence. The actual expert estimate of prevalence is around 0.8%-1.8% in pediatric populations, although there is a large published range depending on whether the criteria are modified or not.2 Use of the unmodified criteria from the DSM-5 is the recommended approach. Bipolar disorder is exceedingly rare in prepubertal children, and it would be more common for prodromal symptoms such as Carrie’s to emerge and escalate over the teenage years, culminating in a clearer diagnosis in the later teens or 20s.3

In my screening questions, I find the idea of an “infatiguable state” is the most pathognomonic one in considering mania in bipolar disorder.4 Carrie’s “crashing” after nights of studying shows that she clearly fatigues. Patients with bipolar disorder within episodes of hypomania or mania have a seismic shift in perceived energy and a matching lack of ability to sleep that can affect their thought processes, speech, and decision-making. At first blush, Carrie’s history does not indicate current symptoms of bipolar disorder.3
 

Case, continued

When you meet with Carrie alone she shares that she has been experimenting with prescribed stimulants from her older college-aged brother in order to study and ace her tests. She is also experimenting with alcohol and marijuana with her friends. You provide her the CRAFFT tool to deepen your screening of this issue.5

With her mother, you administer the Parent General Behavior Inventory6 and the and the Child Mania Rating Scale7. From these scales, you note that the irritability is more specific to Carrie’s family than pan-present in school and with friends. Her lack of sleep occurs at high-pressure and discreet times.

At this point, you reassure Carrie and her mother that Carrie does not present with symptoms of bipolar disorder but that certainly you will continue screening assessments over time, as they are a good means to track symptoms. You also recommend that Carrie consider mood tracking so she can develop insights into her mood and its relationship to sleep and other events as she prepares for college.8
 

Case discussion, continued

The strongest risk factor for bipolar disorder in youth is family history (specifically a parent) with bipolar disorder).9 If there is the chance to explore the parent’s illness with open-ended questions, you will want to hear about the parent’s age of symptom onset, course of treatment, any hospitalizations, and stabilizing medications because this has prognostic power for your patient. It is important to ensure that the parent indeed has a diagnosis of bipolar disorder and that it is not just being used colloquially to characterize an adult who has labile moods from hour to hour or day to day. This would give undue anticipatory anxiety to a youth about their risk, which is up to 8- to 10-fold greater with a parent with bipolar disorder.9

Even with a strong family history, we do not often see bipolar disorder emerge in prepubertal children.10,11 There may be still concerning prodromal symptoms in which a diagnosis of unipolar depression with more irritable features and mood lability seems more commonly complicated by substance use, as with Carrie.

Activation with an SSRI, as in Carrie’s case, even if not resulting in full mania or hypomania, can also be a soft sign of the serotonergic sensitivity present in bipolar disorder. However, if there are not additional symptoms of bipolar disorder and you are concerned based on family history alone, you do not want to withhold antidepressant treatment because fear of risk. You would want to consider a “dose low and go slow” titration process with more frequent monitoring.

A diagnostic interview with a child and adolescent psychiatrist and administration of scales such as the Young Mania Rating Scale and the Modified Child Depression Rating Scale are the standard means to assess for bipolar symptoms.12 Considering the dearth of child psychiatrists nationally, it would be useful to improve one’s screening in primary care so as to not inadvertently “refer out” all patients for whom mood dysregulation is a concern.

There is also a more expanded tool that includes several scales integrated with clinical information (parent’s age of mood disorder onset, child’s age) which can culminate in a risk score.13

Lastly, I provide my patients with a handout of the Young Mania Rating Scale to take home as a reference and to complete before our next visit.14

You can repeat scales to monitor for more striking bipolar disorder signs and symptoms that emerge over the course of one’s longitudinal treatment of a pediatric patient. This can be an ongoing, episodic assessment since the emergence of bipolar disorder has been shown to range from the teenage years and beyond into the 20s and sometimes 30s.
 

Case, continued

Carrie presents to you again while in her first semester of college at the age of 19. She is taking a leave of absence after she began experimenting with cocaine at college and had a manic episode characterized by a lack of sleep without fatigue, persistent unabating energy, rapid and pressured speech, and ultimately, concern from her college friends. She was admitted to a psychiatric unit and stabilized on a second-generation antipsychotic, risperidone, which has solid evidence for mania, but she and you are now concerned about longer-term metabolic effects.15,16

You discuss monitoring her lipid profile and hemoglobin A1c, in addition to weight gain and waist circumference. She has connected with a therapist and psychiatrist through the college counseling center and hopes to return next semester with a fresh start and commitment to sobriety and social rhythms therapy known to be helpful for patients with bipolar disorder.17

While it is challenging to manage a chronic illness at her age, she feels hopeful that she can make better choices for her overall health with your support and the support of her family and mental health team.

Dr. Pawlowski is a child and adolescent consulting psychiatrist. She is a division chief at the University of Vermont Medical Center, Burlington, where she focuses on primary care mental health integration within primary care pediatrics, internal medicine, and family medicine.
 

References

1. Bipolar Disord. 2016 Jan 9 doi: 10.1111/bdi.12358.

2. Int J Bipolar Disord. 2021 Jun 25. doi: 10.1186/s40345-021-00225-5.

3. Am J Psychiatry. 2018 Dec 11. doi: 10.1176/appi.ajp.2018.18040461.

4. DSM-5 Changes: Implications for Child Serious Emotional Disturbance. Rockville, Md.: Substance Abuse and Mental Health Services Administration, 2016.

5. The CRAFFT tool.

6. General Behavior Inventory. Parent Version (P-GBI) Short Form – H/B (Revised Version, 2008).

7. Child Mania Rating Scale, Parent Version (CMRS-P).

8. https://www.moodtracker.com.

9. J Clin Psychiatry. 2000 Sep. doi: 10.4088/jcp.v61n0906.

10. Int J Bipolar Disord. 2020 Apr 20. doi: 10.1186/s40345-020-00185-2.

11. Int J Bipolar Disord. 2021 Jun 25. doi: 10.1186/s40345-021-00225-5.

12. Bipolar Disord. 2017 Sep 25. doi: 10.1111/bdi.12556.

13. www.cabsresearch.pitt.edu/bpriskcalculator/.

14. Parent Version of the Young Mania Rating Scale (PYMRS).

15. Arch Gen Psychiatry. 2012 Jan 2. doi: 10.1001/archgenpsychiatry.2011.1508.

16. The Carlat Child Psychiatry Report. “Bipolar Disorder” Newburyport, Mass.: Carlat Publishing, 2012.

17. https://www.ipsrt.org/.

A program to increase the use of magnesium sulfate to reduce the risk of cerebral palsy is effective, say researchers. Giving magnesium sulfate to women at risk of premature birth can reduce the risk of a child having cerebral palsy by a third, and costs just £1 per dose.

However, the authors of the new observational study, published in Archives of Disease in Childhood – Fetal and Neonatal Edition, pointed out that in 2017 only around two-thirds (64%) of eligible women were being given magnesium sulfate in England, Scotland, and Wales, with “wide regional variations.”

To address this, in 2014 the PReCePT (Preventing Cerebral Palsy in Pre Term labor) quality improvement toolkit was developed by both parents and staff with the aim of supporting all maternity units in England to improve maternity staff awareness and increase the use of magnesium sulfate in mothers at risk of giving birth at 30 weeks’ gestation or under. PReCePT provided practical tools and training to support hospital staff to give magnesium sulfate to eligible mothers.

The pilot study in 2015, which involved five maternity units, found an increase in uptake from 21% to 88% associated with the PReCePT approach. Subsequently, in 2018, NHS England funded the National PReCePT Programme, which scaled up the intervention for national roll-out and provided the PReCePT quality toolkit – which includes preterm labor proforma, staff training presentations, parent information leaflet, posters for the unit, and a learning log – to each maternity unit.
 

Improvement ‘over and above’ expectation

For the first evaluation of a U.K. universally implemented national perinatal quality improvement program to increase administration of an evidence-based drug, researchers, led by University of Bristol, England, set out to evaluate the effectiveness and cost-effectiveness of the National PReCePT Programme in increasing use of magnesium sulfate in preterm births.

Using data from the U.K. National Neonatal Research Database for the year before and the year after PReCePT was implemented in maternity units in England, the researchers performed a before-and-after study that involved 137 maternity units within NHS England. Participants were babies born at 30 weeks’ gestation or under admitted to neonatal units in England, and the main outcome measure was magnesium sulfate uptake before and after the implementation of the National PReCePT Programme. In addition, implementation and lifetime costs were estimated.

During the first year, post implementation of the program, uptake increased by an average of 6.3 percentage points (to 83.1%) across all maternity units in England, which the authors explained was “over and above” the increase that would be expected over time as the practice spread organically. The researchers also found that after adjusting for variations in when maternity units started the program, the increase in use of magnesium sulfate was 9.5 percentage points. “By May 2020, on average 86.4% of eligible mothers were receiving magnesium sulfate,” they said.

Professor John Macleod, NIHR ARC West Director, professor in clinical epidemiology and primary care, University of Bristol, and principal investigator of the evaluation, said: “Our in-depth analysis has been able to demonstrate that the PReCePT program is both effective and cost-effective. The program has increased uptake of magnesium sulfate, which we know is a cost-effective medicine to prevent cerebral palsy, much more quickly than we could have otherwise expected.”

From a societal and lifetime perspective, the health gains and cost savings associated with the National PReCePT Programme generated a “net monetary benefit of £866 per preterm baby,” with the probability of the program being cost-effective being “greater than 95%,” the authors highlighted.

The researchers also estimated that the program’s first year could be associated with a lifetime saving to society of £3 million – which accounts for the costs of the program, of administering the treatment, of cerebral palsy to society over a lifetime, and the associated health gains of avoiding cases. “This is across all the extra babies the program helped get access to the treatment during the first year,” they said.

The authors highlighted that in the five pilot sites, the improved use of magnesium sulfate has been “sustained over the years” since PReCePT was implemented. As the program costs were mostly in the first year of implementation, longer-term national analysis may show that PReCePT is “even more cost-effective over a longer period,” they postulated.
 

Accelerate uptake

Uptake of new evidence or guidelines is often “slow” due to practical barriers, lack of knowledge, and need for behavior change, and can “take decades to become embedded” in perinatal clinical practice, expressed the authors, which in turn comes at a “high clinical and economic cost.”

Karen Luyt, professor in neonatal medicine, University of Bristol, said: “The PReCePT national quality improvement program demonstrates that a collaborative and coordinated perinatal implementation program supporting every hospital in England can accelerate the uptake of new evidence-based treatments into routine practice, enabling equitable health benefits to babies and ultimately reductions in lifetime societal costs.”

The authors said the PReCePT model “may serve as a blueprint for future interventions to improve perinatal care.”

Professor Lucy Chappell, chief executive officer of the National Institute for Health and Care Research, said: “This important study shows the impact of taking a promising intervention that had been shown to work in a research setting and scaling it up across the country. Giving magnesium sulfate to prevent cerebral palsy in premature babies is a simple, inexpensive intervention that can make such a difference to families and the health service.”

Prof. Macleod added: “We are pleased to have played a part in helping get this cheap yet effective treatment to more babies.”

This work was jointly funded by the National Institute for Health and Care Research Applied Research Collaboration West and the AHSN Network funded by NHS England. The Health Foundation funded the health economics evaluation. The authors declare that the study management group has no competing financial, professional, or personal interests that might have influenced the study design or conduct.

A version of this article first appeared on Medscape UK.

A program to increase the use of magnesium sulfate to reduce the risk of cerebral palsy is effective, say researchers. Giving magnesium sulfate to women at risk of premature birth can reduce the risk of a child having cerebral palsy by a third, and costs just £1 per dose.

However, the authors of the new observational study, published in Archives of Disease in Childhood – Fetal and Neonatal Edition, pointed out that in 2017 only around two-thirds (64%) of eligible women were being given magnesium sulfate in England, Scotland, and Wales, with “wide regional variations.”

To address this, in 2014 the PReCePT (Preventing Cerebral Palsy in Pre Term labor) quality improvement toolkit was developed by both parents and staff with the aim of supporting all maternity units in England to improve maternity staff awareness and increase the use of magnesium sulfate in mothers at risk of giving birth at 30 weeks’ gestation or under. PReCePT provided practical tools and training to support hospital staff to give magnesium sulfate to eligible mothers.

The pilot study in 2015, which involved five maternity units, found an increase in uptake from 21% to 88% associated with the PReCePT approach. Subsequently, in 2018, NHS England funded the National PReCePT Programme, which scaled up the intervention for national roll-out and provided the PReCePT quality toolkit – which includes preterm labor proforma, staff training presentations, parent information leaflet, posters for the unit, and a learning log – to each maternity unit.
 

Improvement ‘over and above’ expectation

For the first evaluation of a U.K. universally implemented national perinatal quality improvement program to increase administration of an evidence-based drug, researchers, led by University of Bristol, England, set out to evaluate the effectiveness and cost-effectiveness of the National PReCePT Programme in increasing use of magnesium sulfate in preterm births.

Using data from the U.K. National Neonatal Research Database for the year before and the year after PReCePT was implemented in maternity units in England, the researchers performed a before-and-after study that involved 137 maternity units within NHS England. Participants were babies born at 30 weeks’ gestation or under admitted to neonatal units in England, and the main outcome measure was magnesium sulfate uptake before and after the implementation of the National PReCePT Programme. In addition, implementation and lifetime costs were estimated.

During the first year, post implementation of the program, uptake increased by an average of 6.3 percentage points (to 83.1%) across all maternity units in England, which the authors explained was “over and above” the increase that would be expected over time as the practice spread organically. The researchers also found that after adjusting for variations in when maternity units started the program, the increase in use of magnesium sulfate was 9.5 percentage points. “By May 2020, on average 86.4% of eligible mothers were receiving magnesium sulfate,” they said.

Professor John Macleod, NIHR ARC West Director, professor in clinical epidemiology and primary care, University of Bristol, and principal investigator of the evaluation, said: “Our in-depth analysis has been able to demonstrate that the PReCePT program is both effective and cost-effective. The program has increased uptake of magnesium sulfate, which we know is a cost-effective medicine to prevent cerebral palsy, much more quickly than we could have otherwise expected.”

From a societal and lifetime perspective, the health gains and cost savings associated with the National PReCePT Programme generated a “net monetary benefit of £866 per preterm baby,” with the probability of the program being cost-effective being “greater than 95%,” the authors highlighted.

The researchers also estimated that the program’s first year could be associated with a lifetime saving to society of £3 million – which accounts for the costs of the program, of administering the treatment, of cerebral palsy to society over a lifetime, and the associated health gains of avoiding cases. “This is across all the extra babies the program helped get access to the treatment during the first year,” they said.

The authors highlighted that in the five pilot sites, the improved use of magnesium sulfate has been “sustained over the years” since PReCePT was implemented. As the program costs were mostly in the first year of implementation, longer-term national analysis may show that PReCePT is “even more cost-effective over a longer period,” they postulated.
 

Accelerate uptake

Uptake of new evidence or guidelines is often “slow” due to practical barriers, lack of knowledge, and need for behavior change, and can “take decades to become embedded” in perinatal clinical practice, expressed the authors, which in turn comes at a “high clinical and economic cost.”

Karen Luyt, professor in neonatal medicine, University of Bristol, said: “The PReCePT national quality improvement program demonstrates that a collaborative and coordinated perinatal implementation program supporting every hospital in England can accelerate the uptake of new evidence-based treatments into routine practice, enabling equitable health benefits to babies and ultimately reductions in lifetime societal costs.”

The authors said the PReCePT model “may serve as a blueprint for future interventions to improve perinatal care.”

Professor Lucy Chappell, chief executive officer of the National Institute for Health and Care Research, said: “This important study shows the impact of taking a promising intervention that had been shown to work in a research setting and scaling it up across the country. Giving magnesium sulfate to prevent cerebral palsy in premature babies is a simple, inexpensive intervention that can make such a difference to families and the health service.”

Prof. Macleod added: “We are pleased to have played a part in helping get this cheap yet effective treatment to more babies.”

This work was jointly funded by the National Institute for Health and Care Research Applied Research Collaboration West and the AHSN Network funded by NHS England. The Health Foundation funded the health economics evaluation. The authors declare that the study management group has no competing financial, professional, or personal interests that might have influenced the study design or conduct.

A version of this article first appeared on Medscape UK.

A program to increase the use of magnesium sulfate to reduce the risk of cerebral palsy is effective, say researchers. Giving magnesium sulfate to women at risk of premature birth can reduce the risk of a child having cerebral palsy by a third, and costs just £1 per dose.

However, the authors of the new observational study, published in Archives of Disease in Childhood – Fetal and Neonatal Edition, pointed out that in 2017 only around two-thirds (64%) of eligible women were being given magnesium sulfate in England, Scotland, and Wales, with “wide regional variations.”

To address this, in 2014 the PReCePT (Preventing Cerebral Palsy in Pre Term labor) quality improvement toolkit was developed by both parents and staff with the aim of supporting all maternity units in England to improve maternity staff awareness and increase the use of magnesium sulfate in mothers at risk of giving birth at 30 weeks’ gestation or under. PReCePT provided practical tools and training to support hospital staff to give magnesium sulfate to eligible mothers.

The pilot study in 2015, which involved five maternity units, found an increase in uptake from 21% to 88% associated with the PReCePT approach. Subsequently, in 2018, NHS England funded the National PReCePT Programme, which scaled up the intervention for national roll-out and provided the PReCePT quality toolkit – which includes preterm labor proforma, staff training presentations, parent information leaflet, posters for the unit, and a learning log – to each maternity unit.
 

Improvement ‘over and above’ expectation

For the first evaluation of a U.K. universally implemented national perinatal quality improvement program to increase administration of an evidence-based drug, researchers, led by University of Bristol, England, set out to evaluate the effectiveness and cost-effectiveness of the National PReCePT Programme in increasing use of magnesium sulfate in preterm births.

Using data from the U.K. National Neonatal Research Database for the year before and the year after PReCePT was implemented in maternity units in England, the researchers performed a before-and-after study that involved 137 maternity units within NHS England. Participants were babies born at 30 weeks’ gestation or under admitted to neonatal units in England, and the main outcome measure was magnesium sulfate uptake before and after the implementation of the National PReCePT Programme. In addition, implementation and lifetime costs were estimated.

During the first year, post implementation of the program, uptake increased by an average of 6.3 percentage points (to 83.1%) across all maternity units in England, which the authors explained was “over and above” the increase that would be expected over time as the practice spread organically. The researchers also found that after adjusting for variations in when maternity units started the program, the increase in use of magnesium sulfate was 9.5 percentage points. “By May 2020, on average 86.4% of eligible mothers were receiving magnesium sulfate,” they said.

Professor John Macleod, NIHR ARC West Director, professor in clinical epidemiology and primary care, University of Bristol, and principal investigator of the evaluation, said: “Our in-depth analysis has been able to demonstrate that the PReCePT program is both effective and cost-effective. The program has increased uptake of magnesium sulfate, which we know is a cost-effective medicine to prevent cerebral palsy, much more quickly than we could have otherwise expected.”

From a societal and lifetime perspective, the health gains and cost savings associated with the National PReCePT Programme generated a “net monetary benefit of £866 per preterm baby,” with the probability of the program being cost-effective being “greater than 95%,” the authors highlighted.

The researchers also estimated that the program’s first year could be associated with a lifetime saving to society of £3 million – which accounts for the costs of the program, of administering the treatment, of cerebral palsy to society over a lifetime, and the associated health gains of avoiding cases. “This is across all the extra babies the program helped get access to the treatment during the first year,” they said.

The authors highlighted that in the five pilot sites, the improved use of magnesium sulfate has been “sustained over the years” since PReCePT was implemented. As the program costs were mostly in the first year of implementation, longer-term national analysis may show that PReCePT is “even more cost-effective over a longer period,” they postulated.
 

Accelerate uptake

Uptake of new evidence or guidelines is often “slow” due to practical barriers, lack of knowledge, and need for behavior change, and can “take decades to become embedded” in perinatal clinical practice, expressed the authors, which in turn comes at a “high clinical and economic cost.”

Karen Luyt, professor in neonatal medicine, University of Bristol, said: “The PReCePT national quality improvement program demonstrates that a collaborative and coordinated perinatal implementation program supporting every hospital in England can accelerate the uptake of new evidence-based treatments into routine practice, enabling equitable health benefits to babies and ultimately reductions in lifetime societal costs.”

The authors said the PReCePT model “may serve as a blueprint for future interventions to improve perinatal care.”

Professor Lucy Chappell, chief executive officer of the National Institute for Health and Care Research, said: “This important study shows the impact of taking a promising intervention that had been shown to work in a research setting and scaling it up across the country. Giving magnesium sulfate to prevent cerebral palsy in premature babies is a simple, inexpensive intervention that can make such a difference to families and the health service.”

Prof. Macleod added: “We are pleased to have played a part in helping get this cheap yet effective treatment to more babies.”

This work was jointly funded by the National Institute for Health and Care Research Applied Research Collaboration West and the AHSN Network funded by NHS England. The Health Foundation funded the health economics evaluation. The authors declare that the study management group has no competing financial, professional, or personal interests that might have influenced the study design or conduct.

A version of this article first appeared on Medscape UK.

As vice principal of Pennsville Middle School in New Jersey, Adam J. Slusher knows he’s not always going to be Mr. Popularity. 

Part of a vice principal’s job includes scheduling, enforcing policy, and discipline, so Dr. Slusher – who holds a doctorate in education from Wilmington University in Delaware – sometimes has to send emails or make phone calls that address unpleasant topics or unpopular new policies.

Or punishments.

But there was a much different reaction this past July, after he sent a message to the homes of Pennsville’s 450 students spanning grades 6 to 8. The email blast announced a new cellphone policy for the school. Starting in September, as he explained in the message – which also went out to the school’s 60 faculty and staff members – the use of cellphones by Pennsville students would be prohibited during school hours for any reason.

Phones, he emphasized, “are to be turned OFF” and stowed away in backpacks or handbags, not carried or tucked into back pockets.

The announcement of the new Away for the Day policy, which was decided upon by Dr. Slusher and Pennsville Principal Carolyn Carels, provoked a response different from those to his announcements on, say, test dates, emergency procedures, or new detention policies. 

“It was one of the most popular emails I’ve ever sent,” chuckled Dr. Slusher, who has been an educator for 17 years. “We’ve gotten so many thanks from teachers for this.”

Ditto with the staff, who in conversations with Dr. Slusher and Ms. Carels, had reported on the rampant use of phones in the cafeteria and hallways – confirming what both of them had seen. 

“They were telling us, ‘You’ve got to do something about the phones’ ” he recalled. “They were delighted that a clear policy was now going to be in place.”

The overwhelming majority of Pennsville parents have also supported the new policy, especially when presented with some of the sobering evidence about the extent of phone use among this population. One study Dr. Slusher cited in his email showed that the average middle school child is spending between 6 and 9 hours a day on screens. 

“That’s like a full-time job,” he said. 

The heavy cellphone use by kids – in school, out of school, anywhere and everywhere – was part of what prompted internal medicine doctor and filmmaker Delaney Ruston, MD, to create the “Away for the Day” initiative, which Pennsville has adopted.

She and collaborator Lisa Tabb were driven to do “Away for the Day” while working on Screenagers, their award-winning 2016 film examining the impact of social media, videos, and screen time on youngsters and their families that also offered tips for better navigating the digital world.

“Over 3 years of making the film, I was visiting schools all over the country,” Dr. Ruston said. “By the end, I was seeing devices all over the place, even in elementary schools. When I’d ask a student in the hall, ‘What’s the policy?’ they would shrug and say ‘I don’t know.’ When I got the same reaction from teachers – who in many cases were left to decide on their own, so that they had to be the bad guys – I realized there was a problem here.”

The result was what Dr. Ruston and Ms. Tabb describe on their website as a “movement,” designed to provide tools to parents, teachers, and administrators to help them make policies that put phones away during the school day. 
 

The age of social centrality 

As even a casual glance in the homeroom of every high school or college lecture hall will confirm, phone use is high in teenagers and young adults. But Dr. Ruston and Ms. Tabb decided to focus on middle schools. 

“That’s the age where we know schools are facing the most challenges,” Dr. Ruston said. “This is also the age when social centrality becomes a major focus for youth. Thus, the pull to be on social media games, where their peers are, is incredibly enticing.” 

A recent study in the journal JAMA Pediatrics found that middle schoolers who compulsively check social networks on their phones appear to have changes in areas of the brain linked to reward and punishment.

It was in middle schools, she concluded, “where effective policies on cellphones are most needed.”

As part of their research into the issue, she and ms. Tabb did a survey using email contacts collected by Dr. Ruston’s company, MyDoc Productions, during the making of the film, along with subscribers to her blog. In all, 1,200 parents – each of whom had at least one child in middle school at the time – were surveyed. The researchers found an interesting disconnect: Eighty-two percent of the parents surveyed did not want their children using phones in school. Yet 55% of middle schools allowed students to carry phones during the school day.

That survey was done in 2017. Since the COVID-19 pandemic, the use of cellphones by children, both in school and at home, has risen dramatically. A literature review of 46 studies, published in JAMA Pediatrics in November, found that average screen time among children and adolescents has increased by 52% – or 84 minutes a day – during the pandemic.

That trend  has given many schools, including Pennsville, the drive to adopt an Away for the Day–type policy. As part of the program, Dr. Ruston’s website provides ammunition against the kinds of pushback they might expect to get. One of the most common is the idea that banning cellphone use among middle school children is a misguided, antitechnology measure.

“We’re not at all antitech,” Dr. Ruston asserts. Away for the Day, she explains, advocates the use of learning technologies in school that are monitored and supervised by teachers. 

“The majority of students have access to learning devices in the school,” she said. “These have different kinds of blockers, making it harder for their kid to respond to their friend on TikTok when they’re supposed to be using technology for learning.”

Dr. Ruston estimates that about 10,000 middle schools are now using various pieces of the Away for the Day campaign, which includes videos, posters, fact sheets, and other materials. Other schools have adopted similar measures in the same spirit. 
 

Predictable and calm? Not so much

When Katherine Holden was named principal of Oregon’s Talent Middle School in 2022, one of the first things she wanted to do was create some structure for the routines of students (and parents) who were frazzled after 2 years of remote learning, staggered schedules, and mask mandates.

“Predictable and calm,” she said, with a laugh. “I use those words every day.”

Achieving both is hard enough in a middle school without a pandemic – not to mention an epidemic of cellphone use. (Talent also endured a massive fire in 2020 that left many families homeless.) 

For this school year, Ms. Holden is using a new and clearly articulated policy: “Devices are put away from the first bell to the last bell,” she said. “We want them to have a focus on other things. We want them to be socializing, interacting with their peers face to face, thinking about getting to class. We want them making eye contact, asking questions. Learning how to make a friend face to face. Those are important developmental social skills they should be practicing.”

Instead of scrolling through photos on Instagram, watching trending videos on TikTok, or texting their friends.

Like Dr. Slusher, she announced the new cellphone policy last summer, in a letter sent home to parents along with the list of school supplies their children would need. 

“Students are welcome to use their cell phones and personal devices before entering the building prior to 8:30 a.m. and after exiting the school building at 3:10 p.m.,” she wrote. “However, during the school day students’ cellphones and personal devices need to be off and out of sight.

“I think parents generally understand the need for this,” Ms. Holden said. “They’ve watched their children getting distracted at home by these devices, so they have a sense of how a cellphone adds a layer of challenge to learning. And parents are aware of the unkind behavior that often happens online.”

As for the kids themselves? Safe to say the excitement that Dr. Slusher’s email got from Pennsville faculty, staff, and parents didn’t extend to students. 

“They don’t like it all, to be honest,” he said. “But they understand it’s for their benefit. When we sold it to them at our beginning-of-the-year meeting, we presented our rationale. From the kids I speak to, I think the majority understand why we’re doing it.”

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

As vice principal of Pennsville Middle School in New Jersey, Adam J. Slusher knows he’s not always going to be Mr. Popularity. 

Part of a vice principal’s job includes scheduling, enforcing policy, and discipline, so Dr. Slusher – who holds a doctorate in education from Wilmington University in Delaware – sometimes has to send emails or make phone calls that address unpleasant topics or unpopular new policies.

Or punishments.

But there was a much different reaction this past July, after he sent a message to the homes of Pennsville’s 450 students spanning grades 6 to 8. The email blast announced a new cellphone policy for the school. Starting in September, as he explained in the message – which also went out to the school’s 60 faculty and staff members – the use of cellphones by Pennsville students would be prohibited during school hours for any reason.

Phones, he emphasized, “are to be turned OFF” and stowed away in backpacks or handbags, not carried or tucked into back pockets.

The announcement of the new Away for the Day policy, which was decided upon by Dr. Slusher and Pennsville Principal Carolyn Carels, provoked a response different from those to his announcements on, say, test dates, emergency procedures, or new detention policies. 

“It was one of the most popular emails I’ve ever sent,” chuckled Dr. Slusher, who has been an educator for 17 years. “We’ve gotten so many thanks from teachers for this.”

Ditto with the staff, who in conversations with Dr. Slusher and Ms. Carels, had reported on the rampant use of phones in the cafeteria and hallways – confirming what both of them had seen. 

“They were telling us, ‘You’ve got to do something about the phones’ ” he recalled. “They were delighted that a clear policy was now going to be in place.”

The overwhelming majority of Pennsville parents have also supported the new policy, especially when presented with some of the sobering evidence about the extent of phone use among this population. One study Dr. Slusher cited in his email showed that the average middle school child is spending between 6 and 9 hours a day on screens. 

“That’s like a full-time job,” he said. 

The heavy cellphone use by kids – in school, out of school, anywhere and everywhere – was part of what prompted internal medicine doctor and filmmaker Delaney Ruston, MD, to create the “Away for the Day” initiative, which Pennsville has adopted.

She and collaborator Lisa Tabb were driven to do “Away for the Day” while working on Screenagers, their award-winning 2016 film examining the impact of social media, videos, and screen time on youngsters and their families that also offered tips for better navigating the digital world.

“Over 3 years of making the film, I was visiting schools all over the country,” Dr. Ruston said. “By the end, I was seeing devices all over the place, even in elementary schools. When I’d ask a student in the hall, ‘What’s the policy?’ they would shrug and say ‘I don’t know.’ When I got the same reaction from teachers – who in many cases were left to decide on their own, so that they had to be the bad guys – I realized there was a problem here.”

The result was what Dr. Ruston and Ms. Tabb describe on their website as a “movement,” designed to provide tools to parents, teachers, and administrators to help them make policies that put phones away during the school day. 
 

The age of social centrality 

As even a casual glance in the homeroom of every high school or college lecture hall will confirm, phone use is high in teenagers and young adults. But Dr. Ruston and Ms. Tabb decided to focus on middle schools. 

“That’s the age where we know schools are facing the most challenges,” Dr. Ruston said. “This is also the age when social centrality becomes a major focus for youth. Thus, the pull to be on social media games, where their peers are, is incredibly enticing.” 

A recent study in the journal JAMA Pediatrics found that middle schoolers who compulsively check social networks on their phones appear to have changes in areas of the brain linked to reward and punishment.

It was in middle schools, she concluded, “where effective policies on cellphones are most needed.”

As part of their research into the issue, she and ms. Tabb did a survey using email contacts collected by Dr. Ruston’s company, MyDoc Productions, during the making of the film, along with subscribers to her blog. In all, 1,200 parents – each of whom had at least one child in middle school at the time – were surveyed. The researchers found an interesting disconnect: Eighty-two percent of the parents surveyed did not want their children using phones in school. Yet 55% of middle schools allowed students to carry phones during the school day.

That survey was done in 2017. Since the COVID-19 pandemic, the use of cellphones by children, both in school and at home, has risen dramatically. A literature review of 46 studies, published in JAMA Pediatrics in November, found that average screen time among children and adolescents has increased by 52% – or 84 minutes a day – during the pandemic.

That trend  has given many schools, including Pennsville, the drive to adopt an Away for the Day–type policy. As part of the program, Dr. Ruston’s website provides ammunition against the kinds of pushback they might expect to get. One of the most common is the idea that banning cellphone use among middle school children is a misguided, antitechnology measure.

“We’re not at all antitech,” Dr. Ruston asserts. Away for the Day, she explains, advocates the use of learning technologies in school that are monitored and supervised by teachers. 

“The majority of students have access to learning devices in the school,” she said. “These have different kinds of blockers, making it harder for their kid to respond to their friend on TikTok when they’re supposed to be using technology for learning.”

Dr. Ruston estimates that about 10,000 middle schools are now using various pieces of the Away for the Day campaign, which includes videos, posters, fact sheets, and other materials. Other schools have adopted similar measures in the same spirit. 
 

Predictable and calm? Not so much

When Katherine Holden was named principal of Oregon’s Talent Middle School in 2022, one of the first things she wanted to do was create some structure for the routines of students (and parents) who were frazzled after 2 years of remote learning, staggered schedules, and mask mandates.

“Predictable and calm,” she said, with a laugh. “I use those words every day.”

Achieving both is hard enough in a middle school without a pandemic – not to mention an epidemic of cellphone use. (Talent also endured a massive fire in 2020 that left many families homeless.) 

For this school year, Ms. Holden is using a new and clearly articulated policy: “Devices are put away from the first bell to the last bell,” she said. “We want them to have a focus on other things. We want them to be socializing, interacting with their peers face to face, thinking about getting to class. We want them making eye contact, asking questions. Learning how to make a friend face to face. Those are important developmental social skills they should be practicing.”

Instead of scrolling through photos on Instagram, watching trending videos on TikTok, or texting their friends.

Like Dr. Slusher, she announced the new cellphone policy last summer, in a letter sent home to parents along with the list of school supplies their children would need. 

“Students are welcome to use their cell phones and personal devices before entering the building prior to 8:30 a.m. and after exiting the school building at 3:10 p.m.,” she wrote. “However, during the school day students’ cellphones and personal devices need to be off and out of sight.

“I think parents generally understand the need for this,” Ms. Holden said. “They’ve watched their children getting distracted at home by these devices, so they have a sense of how a cellphone adds a layer of challenge to learning. And parents are aware of the unkind behavior that often happens online.”

As for the kids themselves? Safe to say the excitement that Dr. Slusher’s email got from Pennsville faculty, staff, and parents didn’t extend to students. 

“They don’t like it all, to be honest,” he said. “But they understand it’s for their benefit. When we sold it to them at our beginning-of-the-year meeting, we presented our rationale. From the kids I speak to, I think the majority understand why we’re doing it.”

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

As vice principal of Pennsville Middle School in New Jersey, Adam J. Slusher knows he’s not always going to be Mr. Popularity. 

Part of a vice principal’s job includes scheduling, enforcing policy, and discipline, so Dr. Slusher – who holds a doctorate in education from Wilmington University in Delaware – sometimes has to send emails or make phone calls that address unpleasant topics or unpopular new policies.

Or punishments.

But there was a much different reaction this past July, after he sent a message to the homes of Pennsville’s 450 students spanning grades 6 to 8. The email blast announced a new cellphone policy for the school. Starting in September, as he explained in the message – which also went out to the school’s 60 faculty and staff members – the use of cellphones by Pennsville students would be prohibited during school hours for any reason.

Phones, he emphasized, “are to be turned OFF” and stowed away in backpacks or handbags, not carried or tucked into back pockets.

The announcement of the new Away for the Day policy, which was decided upon by Dr. Slusher and Pennsville Principal Carolyn Carels, provoked a response different from those to his announcements on, say, test dates, emergency procedures, or new detention policies. 

“It was one of the most popular emails I’ve ever sent,” chuckled Dr. Slusher, who has been an educator for 17 years. “We’ve gotten so many thanks from teachers for this.”

Ditto with the staff, who in conversations with Dr. Slusher and Ms. Carels, had reported on the rampant use of phones in the cafeteria and hallways – confirming what both of them had seen. 

“They were telling us, ‘You’ve got to do something about the phones’ ” he recalled. “They were delighted that a clear policy was now going to be in place.”

The overwhelming majority of Pennsville parents have also supported the new policy, especially when presented with some of the sobering evidence about the extent of phone use among this population. One study Dr. Slusher cited in his email showed that the average middle school child is spending between 6 and 9 hours a day on screens. 

“That’s like a full-time job,” he said. 

The heavy cellphone use by kids – in school, out of school, anywhere and everywhere – was part of what prompted internal medicine doctor and filmmaker Delaney Ruston, MD, to create the “Away for the Day” initiative, which Pennsville has adopted.

She and collaborator Lisa Tabb were driven to do “Away for the Day” while working on Screenagers, their award-winning 2016 film examining the impact of social media, videos, and screen time on youngsters and their families that also offered tips for better navigating the digital world.

“Over 3 years of making the film, I was visiting schools all over the country,” Dr. Ruston said. “By the end, I was seeing devices all over the place, even in elementary schools. When I’d ask a student in the hall, ‘What’s the policy?’ they would shrug and say ‘I don’t know.’ When I got the same reaction from teachers – who in many cases were left to decide on their own, so that they had to be the bad guys – I realized there was a problem here.”

The result was what Dr. Ruston and Ms. Tabb describe on their website as a “movement,” designed to provide tools to parents, teachers, and administrators to help them make policies that put phones away during the school day. 
 

The age of social centrality 

As even a casual glance in the homeroom of every high school or college lecture hall will confirm, phone use is high in teenagers and young adults. But Dr. Ruston and Ms. Tabb decided to focus on middle schools. 

“That’s the age where we know schools are facing the most challenges,” Dr. Ruston said. “This is also the age when social centrality becomes a major focus for youth. Thus, the pull to be on social media games, where their peers are, is incredibly enticing.” 

A recent study in the journal JAMA Pediatrics found that middle schoolers who compulsively check social networks on their phones appear to have changes in areas of the brain linked to reward and punishment.

It was in middle schools, she concluded, “where effective policies on cellphones are most needed.”

As part of their research into the issue, she and ms. Tabb did a survey using email contacts collected by Dr. Ruston’s company, MyDoc Productions, during the making of the film, along with subscribers to her blog. In all, 1,200 parents – each of whom had at least one child in middle school at the time – were surveyed. The researchers found an interesting disconnect: Eighty-two percent of the parents surveyed did not want their children using phones in school. Yet 55% of middle schools allowed students to carry phones during the school day.

That survey was done in 2017. Since the COVID-19 pandemic, the use of cellphones by children, both in school and at home, has risen dramatically. A literature review of 46 studies, published in JAMA Pediatrics in November, found that average screen time among children and adolescents has increased by 52% – or 84 minutes a day – during the pandemic.

That trend  has given many schools, including Pennsville, the drive to adopt an Away for the Day–type policy. As part of the program, Dr. Ruston’s website provides ammunition against the kinds of pushback they might expect to get. One of the most common is the idea that banning cellphone use among middle school children is a misguided, antitechnology measure.

“We’re not at all antitech,” Dr. Ruston asserts. Away for the Day, she explains, advocates the use of learning technologies in school that are monitored and supervised by teachers. 

“The majority of students have access to learning devices in the school,” she said. “These have different kinds of blockers, making it harder for their kid to respond to their friend on TikTok when they’re supposed to be using technology for learning.”

Dr. Ruston estimates that about 10,000 middle schools are now using various pieces of the Away for the Day campaign, which includes videos, posters, fact sheets, and other materials. Other schools have adopted similar measures in the same spirit. 
 

Predictable and calm? Not so much

When Katherine Holden was named principal of Oregon’s Talent Middle School in 2022, one of the first things she wanted to do was create some structure for the routines of students (and parents) who were frazzled after 2 years of remote learning, staggered schedules, and mask mandates.

“Predictable and calm,” she said, with a laugh. “I use those words every day.”

Achieving both is hard enough in a middle school without a pandemic – not to mention an epidemic of cellphone use. (Talent also endured a massive fire in 2020 that left many families homeless.) 

For this school year, Ms. Holden is using a new and clearly articulated policy: “Devices are put away from the first bell to the last bell,” she said. “We want them to have a focus on other things. We want them to be socializing, interacting with their peers face to face, thinking about getting to class. We want them making eye contact, asking questions. Learning how to make a friend face to face. Those are important developmental social skills they should be practicing.”

Instead of scrolling through photos on Instagram, watching trending videos on TikTok, or texting their friends.

Like Dr. Slusher, she announced the new cellphone policy last summer, in a letter sent home to parents along with the list of school supplies their children would need. 

“Students are welcome to use their cell phones and personal devices before entering the building prior to 8:30 a.m. and after exiting the school building at 3:10 p.m.,” she wrote. “However, during the school day students’ cellphones and personal devices need to be off and out of sight.

“I think parents generally understand the need for this,” Ms. Holden said. “They’ve watched their children getting distracted at home by these devices, so they have a sense of how a cellphone adds a layer of challenge to learning. And parents are aware of the unkind behavior that often happens online.”

As for the kids themselves? Safe to say the excitement that Dr. Slusher’s email got from Pennsville faculty, staff, and parents didn’t extend to students. 

“They don’t like it all, to be honest,” he said. “But they understand it’s for their benefit. When we sold it to them at our beginning-of-the-year meeting, we presented our rationale. From the kids I speak to, I think the majority understand why we’re doing it.”

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

The Food and Drug Administration has approved another Tdap vaccine option for use during pregnancy to protect newborns from whooping cough.

The agency on Jan. 9 licensed Adacel (Sanofi Pasteur) for immunization during the third trimester to prevent pertussis in infants younger than 2 months old.

The FDA in October approved a different Tdap vaccine, Boostrix (GlaxoSmithKline), for this indication. Boostrix was the first vaccine specifically approved to prevent a disease in newborns whose mothers receive the vaccine while pregnant.

The Centers for Disease Control and Prevention recommend that women receive a dose of Tdap vaccine during each pregnancy, preferably during gestational weeks 27-36 – and ideally toward the earlier end of that window – to help protect babies from whooping cough, the respiratory tract infection caused by Bordetella pertussis.

Providing a Tdap vaccine – tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed – in the third trimester confers passive immunity to the baby, according to the CDC. It also reduces the likelihood that the mother will get pertussis and pass it on to the infant.

One study found that providing Tdap vaccination during gestational weeks 27-36 was 85% more effective at preventing pertussis in infants younger than 2 months old, compared with providing Tdap vaccination to mothers in the hospital postpartum.

“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” according to a CDC reference page. “Most of these deaths are among infants who are too young to be protected by the childhood pertussis vaccine series that starts when infants are 2 months old.”

The Food and Drug Administration has approved another Tdap vaccine option for use during pregnancy to protect newborns from whooping cough.

The agency on Jan. 9 licensed Adacel (Sanofi Pasteur) for immunization during the third trimester to prevent pertussis in infants younger than 2 months old.

The FDA in October approved a different Tdap vaccine, Boostrix (GlaxoSmithKline), for this indication. Boostrix was the first vaccine specifically approved to prevent a disease in newborns whose mothers receive the vaccine while pregnant.

The Centers for Disease Control and Prevention recommend that women receive a dose of Tdap vaccine during each pregnancy, preferably during gestational weeks 27-36 – and ideally toward the earlier end of that window – to help protect babies from whooping cough, the respiratory tract infection caused by Bordetella pertussis.

Providing a Tdap vaccine – tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed – in the third trimester confers passive immunity to the baby, according to the CDC. It also reduces the likelihood that the mother will get pertussis and pass it on to the infant.

One study found that providing Tdap vaccination during gestational weeks 27-36 was 85% more effective at preventing pertussis in infants younger than 2 months old, compared with providing Tdap vaccination to mothers in the hospital postpartum.

“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” according to a CDC reference page. “Most of these deaths are among infants who are too young to be protected by the childhood pertussis vaccine series that starts when infants are 2 months old.”

The Food and Drug Administration has approved another Tdap vaccine option for use during pregnancy to protect newborns from whooping cough.

The agency on Jan. 9 licensed Adacel (Sanofi Pasteur) for immunization during the third trimester to prevent pertussis in infants younger than 2 months old.

The FDA in October approved a different Tdap vaccine, Boostrix (GlaxoSmithKline), for this indication. Boostrix was the first vaccine specifically approved to prevent a disease in newborns whose mothers receive the vaccine while pregnant.

The Centers for Disease Control and Prevention recommend that women receive a dose of Tdap vaccine during each pregnancy, preferably during gestational weeks 27-36 – and ideally toward the earlier end of that window – to help protect babies from whooping cough, the respiratory tract infection caused by Bordetella pertussis.

Providing a Tdap vaccine – tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine, adsorbed – in the third trimester confers passive immunity to the baby, according to the CDC. It also reduces the likelihood that the mother will get pertussis and pass it on to the infant.

One study found that providing Tdap vaccination during gestational weeks 27-36 was 85% more effective at preventing pertussis in infants younger than 2 months old, compared with providing Tdap vaccination to mothers in the hospital postpartum.

“On average, about 1,000 infants are hospitalized and typically between 5 and 15 infants die each year in the United States due to pertussis,” according to a CDC reference page. “Most of these deaths are among infants who are too young to be protected by the childhood pertussis vaccine series that starts when infants are 2 months old.”

The decline in marriage rates in Canada is sharper among adolescent mothers, new data suggest.

An analysis of data from the Canadian Vital Statistics – Birth Database indicates that marriages declined by 80.5% among mothers younger than 18 years between 1989 and 2018.

“This study documents a decrease in marriage prevalence among mothers aged <18, 18-19, 20-24, and 25-49 years and suggests a larger relative decline in prevalence in younger mothers, especially those below age 18,” wrote study author Andrée-Anne Fafard St-Germain, PhD, a postdoctoral trainee at the University of Toronto, and colleagues.

The study was published online in the Canadian Journal of Public Health.


 

A general decline

The researchers estimated marriage rates among mothers in the four age groups mentioned above. They compared marriage rates in each group during the periods 1989-1990 and 2017-2018. The study included records of 10,399,250 mothers. In all, 1,118,630 records were used to identify socioeconomic and geographic patterns.

The researchers found an expected decline in marriage rates between 1989 and 2018, but the decline was steeper among younger women. Marriage rates decreased by 13.6% among women aged 25-49 years (16.0% relative decline), 29.3% among those aged 20-24 years (47.3% relative decline), 14.3% among those aged 18-19 years (60.2% relative decline), and 6.7% among those under 18 (80.5% relative decline).

Compared with Canadian-born mothers, foreign-born mothers were more likely to be married in all age groups (adjusted odds ratios [aORs], 5.18-6.36). Residence in rural locales or small towns was also associated with greater probability of marriage (aOR, 1.27-1.32).

Compared with women in the prairie provinces, those in Ontario were more likely to be married (aOR, 1.23-1.41), while the rate was lower in Quebec (aOR, 0.27-0.70), the Atlantic Provinces (aOR, 0.49-0.65), and the territories (aOR, 0.26-0.49). The researchers found no statistically significant association between neighborhood income quintiles and marriage rates in those younger than 18. They found a greater likelihood of marriage for mothers aged 18-19 years and those aged 20-24 years who resided in neighborhoods in higher income quintiles.
 

Human rights concern

Commenting on the study, Alissa Koski, PhD, assistant professor of epidemiology, biostatistics, and occupational health at McGill University, said, “Nearly all research on child marriage has focused on countries in South Asia and Africa. The authors acknowledge that child marriage remains legal across Canada. This draws attention to a domestic human rights concern that is largely unacknowledged.”

Overall, the study confirms trends that have been noted in Canada and have been studied by sociologists, Dr. Koski added. Traditional marriage rates have been declining for decades, while common-law marriages have been increasing. The mean age at the time of marriage increased from 30.0 years in 2016 to 30.7 years in 2020, according to Statistics Canada.

The study is limited by its failure to account for common-law marriages, which represent 98% of child marriages, said Dr. Koski. “The percentage of mothers in all age groups who were in legal or common-law marriage is almost certainly much higher than reported in this paper. However, because common-law unions are more common among younger people, the percentage of mothers in younger age groups, including those under 18, may be underestimated to a greater extent.”

The authors’ conclusion that the decline in marriages was larger among mothers younger than 18 years is not supported by the data in the article, said Dr. Koski. “That conclusion seems to overlook the fact that the absolute decline was lowest among those below age 18. The percentage decline in marriage was highest among mothers under 18, but this is at least in part because the percentage was so low to begin with. If we look instead at the absolute decline in marriage, it was lowest among mothers under age 18.”

The authors also suggest that the change in socioeconomic conditions associated with marriage may be different among mothers younger than 18 years, compared with mothers aged 18-19 years or 20-24 years. Higher socioeconomic status, as reflected in higher maternal neighborhood income quintiles, was associated with marriage among older adolescent mothers but not among mothers younger than 18 years. The socioeconomic distinction between married mothers younger than 18 years and older mothers could contribute to differences in the health advantages of marriage over time, the authors wrote.

But this conclusion as well is an “inappropriate interpretation ... not supported by the data,” said Dr. Koski. She noted that births to mothers younger than 18 years are rare in Canada, and births to married mothers in that age group are even rarer. That factor could have led the study to be underpowered in this group and yielded odds ratios that are not statistically significant. “The data are consistent with either an increase or a decrease in the odds of marriage. The data were too sparse to measure accurately,” said Dr. Koski.

The study was funded by the Canadian Institutes of Health Research Foundation. Dr. Fafard St-Germain and Dr. Koski reported having no relevant financial disclosures.

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

The decline in marriage rates in Canada is sharper among adolescent mothers, new data suggest.

An analysis of data from the Canadian Vital Statistics – Birth Database indicates that marriages declined by 80.5% among mothers younger than 18 years between 1989 and 2018.

“This study documents a decrease in marriage prevalence among mothers aged <18, 18-19, 20-24, and 25-49 years and suggests a larger relative decline in prevalence in younger mothers, especially those below age 18,” wrote study author Andrée-Anne Fafard St-Germain, PhD, a postdoctoral trainee at the University of Toronto, and colleagues.

The study was published online in the Canadian Journal of Public Health.


 

A general decline

The researchers estimated marriage rates among mothers in the four age groups mentioned above. They compared marriage rates in each group during the periods 1989-1990 and 2017-2018. The study included records of 10,399,250 mothers. In all, 1,118,630 records were used to identify socioeconomic and geographic patterns.

The researchers found an expected decline in marriage rates between 1989 and 2018, but the decline was steeper among younger women. Marriage rates decreased by 13.6% among women aged 25-49 years (16.0% relative decline), 29.3% among those aged 20-24 years (47.3% relative decline), 14.3% among those aged 18-19 years (60.2% relative decline), and 6.7% among those under 18 (80.5% relative decline).

Compared with Canadian-born mothers, foreign-born mothers were more likely to be married in all age groups (adjusted odds ratios [aORs], 5.18-6.36). Residence in rural locales or small towns was also associated with greater probability of marriage (aOR, 1.27-1.32).

Compared with women in the prairie provinces, those in Ontario were more likely to be married (aOR, 1.23-1.41), while the rate was lower in Quebec (aOR, 0.27-0.70), the Atlantic Provinces (aOR, 0.49-0.65), and the territories (aOR, 0.26-0.49). The researchers found no statistically significant association between neighborhood income quintiles and marriage rates in those younger than 18. They found a greater likelihood of marriage for mothers aged 18-19 years and those aged 20-24 years who resided in neighborhoods in higher income quintiles.
 

Human rights concern

Commenting on the study, Alissa Koski, PhD, assistant professor of epidemiology, biostatistics, and occupational health at McGill University, said, “Nearly all research on child marriage has focused on countries in South Asia and Africa. The authors acknowledge that child marriage remains legal across Canada. This draws attention to a domestic human rights concern that is largely unacknowledged.”

Overall, the study confirms trends that have been noted in Canada and have been studied by sociologists, Dr. Koski added. Traditional marriage rates have been declining for decades, while common-law marriages have been increasing. The mean age at the time of marriage increased from 30.0 years in 2016 to 30.7 years in 2020, according to Statistics Canada.

The study is limited by its failure to account for common-law marriages, which represent 98% of child marriages, said Dr. Koski. “The percentage of mothers in all age groups who were in legal or common-law marriage is almost certainly much higher than reported in this paper. However, because common-law unions are more common among younger people, the percentage of mothers in younger age groups, including those under 18, may be underestimated to a greater extent.”

The authors’ conclusion that the decline in marriages was larger among mothers younger than 18 years is not supported by the data in the article, said Dr. Koski. “That conclusion seems to overlook the fact that the absolute decline was lowest among those below age 18. The percentage decline in marriage was highest among mothers under 18, but this is at least in part because the percentage was so low to begin with. If we look instead at the absolute decline in marriage, it was lowest among mothers under age 18.”

The authors also suggest that the change in socioeconomic conditions associated with marriage may be different among mothers younger than 18 years, compared with mothers aged 18-19 years or 20-24 years. Higher socioeconomic status, as reflected in higher maternal neighborhood income quintiles, was associated with marriage among older adolescent mothers but not among mothers younger than 18 years. The socioeconomic distinction between married mothers younger than 18 years and older mothers could contribute to differences in the health advantages of marriage over time, the authors wrote.

But this conclusion as well is an “inappropriate interpretation ... not supported by the data,” said Dr. Koski. She noted that births to mothers younger than 18 years are rare in Canada, and births to married mothers in that age group are even rarer. That factor could have led the study to be underpowered in this group and yielded odds ratios that are not statistically significant. “The data are consistent with either an increase or a decrease in the odds of marriage. The data were too sparse to measure accurately,” said Dr. Koski.

The study was funded by the Canadian Institutes of Health Research Foundation. Dr. Fafard St-Germain and Dr. Koski reported having no relevant financial disclosures.

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

The decline in marriage rates in Canada is sharper among adolescent mothers, new data suggest.

An analysis of data from the Canadian Vital Statistics – Birth Database indicates that marriages declined by 80.5% among mothers younger than 18 years between 1989 and 2018.

“This study documents a decrease in marriage prevalence among mothers aged <18, 18-19, 20-24, and 25-49 years and suggests a larger relative decline in prevalence in younger mothers, especially those below age 18,” wrote study author Andrée-Anne Fafard St-Germain, PhD, a postdoctoral trainee at the University of Toronto, and colleagues.

The study was published online in the Canadian Journal of Public Health.


 

A general decline

The researchers estimated marriage rates among mothers in the four age groups mentioned above. They compared marriage rates in each group during the periods 1989-1990 and 2017-2018. The study included records of 10,399,250 mothers. In all, 1,118,630 records were used to identify socioeconomic and geographic patterns.

The researchers found an expected decline in marriage rates between 1989 and 2018, but the decline was steeper among younger women. Marriage rates decreased by 13.6% among women aged 25-49 years (16.0% relative decline), 29.3% among those aged 20-24 years (47.3% relative decline), 14.3% among those aged 18-19 years (60.2% relative decline), and 6.7% among those under 18 (80.5% relative decline).

Compared with Canadian-born mothers, foreign-born mothers were more likely to be married in all age groups (adjusted odds ratios [aORs], 5.18-6.36). Residence in rural locales or small towns was also associated with greater probability of marriage (aOR, 1.27-1.32).

Compared with women in the prairie provinces, those in Ontario were more likely to be married (aOR, 1.23-1.41), while the rate was lower in Quebec (aOR, 0.27-0.70), the Atlantic Provinces (aOR, 0.49-0.65), and the territories (aOR, 0.26-0.49). The researchers found no statistically significant association between neighborhood income quintiles and marriage rates in those younger than 18. They found a greater likelihood of marriage for mothers aged 18-19 years and those aged 20-24 years who resided in neighborhoods in higher income quintiles.
 

Human rights concern

Commenting on the study, Alissa Koski, PhD, assistant professor of epidemiology, biostatistics, and occupational health at McGill University, said, “Nearly all research on child marriage has focused on countries in South Asia and Africa. The authors acknowledge that child marriage remains legal across Canada. This draws attention to a domestic human rights concern that is largely unacknowledged.”

Overall, the study confirms trends that have been noted in Canada and have been studied by sociologists, Dr. Koski added. Traditional marriage rates have been declining for decades, while common-law marriages have been increasing. The mean age at the time of marriage increased from 30.0 years in 2016 to 30.7 years in 2020, according to Statistics Canada.

The study is limited by its failure to account for common-law marriages, which represent 98% of child marriages, said Dr. Koski. “The percentage of mothers in all age groups who were in legal or common-law marriage is almost certainly much higher than reported in this paper. However, because common-law unions are more common among younger people, the percentage of mothers in younger age groups, including those under 18, may be underestimated to a greater extent.”

The authors’ conclusion that the decline in marriages was larger among mothers younger than 18 years is not supported by the data in the article, said Dr. Koski. “That conclusion seems to overlook the fact that the absolute decline was lowest among those below age 18. The percentage decline in marriage was highest among mothers under 18, but this is at least in part because the percentage was so low to begin with. If we look instead at the absolute decline in marriage, it was lowest among mothers under age 18.”

The authors also suggest that the change in socioeconomic conditions associated with marriage may be different among mothers younger than 18 years, compared with mothers aged 18-19 years or 20-24 years. Higher socioeconomic status, as reflected in higher maternal neighborhood income quintiles, was associated with marriage among older adolescent mothers but not among mothers younger than 18 years. The socioeconomic distinction between married mothers younger than 18 years and older mothers could contribute to differences in the health advantages of marriage over time, the authors wrote.

But this conclusion as well is an “inappropriate interpretation ... not supported by the data,” said Dr. Koski. She noted that births to mothers younger than 18 years are rare in Canada, and births to married mothers in that age group are even rarer. That factor could have led the study to be underpowered in this group and yielded odds ratios that are not statistically significant. “The data are consistent with either an increase or a decrease in the odds of marriage. The data were too sparse to measure accurately,” said Dr. Koski.

The study was funded by the Canadian Institutes of Health Research Foundation. Dr. Fafard St-Germain and Dr. Koski reported having no relevant financial disclosures.

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

A small cohort study of pediatric rheumatology patients with generalized joint hypermobility (GJH) who presented to a specialized rheumatology* clinic suggests that many such patients have abnormal bleeding symptoms, in comparison with health control patients.

The study of 81 patients with GJH found that about three quarters had significantly elevated median bleeding scores, but only 12% had been assessed by hematology for bleeding.

“We propose that screening for bleeding symptoms should be integrated into the routine care for all patients with GJH, with hematology referrals for patients with increased bleeding concerns,” wrote a research team led by Nicole E. Kendel, MD, a pediatric hematologist-oncologist at Akron Children’s Hospital in Ohio, in a study published online in Arthritis Care and Research.

“Further studies are needed to understand the mechanism of bleeding, evaluate comorbidities associated with these bleeding symptoms, and potentially allow for tailored pharmacologic therapy,” the authors stated.
 

Background

Dr. Kendel’s team had reported moderate menstruation-associated limitations in school, social, and physical activities among female adolescents with GJH. “This cohort also experienced nonreproductive bleeding symptoms and demonstrated minimal hemostatic laboratory abnormalities, indicating that this population may be underdiagnosed and subsequently poorly managed,” she said in an interview. “As excessive bleeding symptoms could have a significant impact on overall health and quality of life, we thought it was important to define the incidence and natural course of bleeding symptoms in a more generalized subset of this population.”

Although the investigators hypothesized that there would be a statistically significant increase in bleeding scores, “we were still impressed by the frequency of abnormal scores, particularly when looking at the low percentage of patients [12%] who had previously been referred to hematology,” she said.
 

Study results

The median age of the study cohort was 13 years (interquartile range, 10-16 years), and 72.8% were female. The mean Beighton score, which measures joint flexibility, was 6.2 (range, 4-9). All participants were seen by rheumatologists and were diagnosed for conditions on the hypermobility spectrum. Those conditions ranged from GJH to hypermobile Ehlers-Danlos syndrome (hEDS).

Abnormal bleeding, as measured by the International Society on Thrombosis and Haemostasis Bleeding Assessment Tool, was found in 75% (95% confidence interval [CI], 64%-84%). Overall mean and median bleeding scores were 5.2 and 4, respectively; scores ranged from 0 to 16. Abnormal scores of ≥ 3 were observed for patients < 8 years of age, ≥ 4 for men ≥ 18 years of age, and ≥ 6 for women ≥ 18 years of age. These measures were significantly elevated compared with those reported for historical healthy pediatric control persons (P < .001).

The most common hemorrhagic symptom was oral bleeding (74.1%) that occurred with tooth brushing, flossing, tooth loss, or eruption. Others reported easy bruising (59.3%) and bleeding from minor wounds (42%). In terms of procedures, tooth extraction requiring additional packing was reported by 25.9%, and 22.2% reported significant bleeding after otolaryngologic procedures, such as tonsillectomy/adenoidectomy, septoplasty, and nasal turbinate reduction.

Prolonged or heavy menstrual periods were reported by 37.3% of female patients.

Bleeding scores did not differ by biological sex or NSAID use, nor did any correlation emerge between patients’ bleeding and Beighton scores. However, there was a positive correlation with increasing age, a phenomenon observed with other bleeding disorders and in the healthy population, the authors noted.

Of the 10 study participants who had previously undergone hematologic assessment, one had been diagnosed with acquired, heart disease–related von Willebrand disease, and another with mild bleeding disorder.

Severe connective tissue disorders are associated with increased bleeding symptoms in the adult population, Dr. Kendel said, but few studies have assessed bleeding across the GJH spectrum, particularly in children.

Bleeding is thought to be due to modifications of collagen in the blood vessels. “These modifications create mechanical weakness of the vessel wall, as well as defective subendothelial connective tissue supporting those blood vessels,” Dr. Kendel explained. She noted that altered collagen creates defective interactions between collagen and other coagulation factors.

“Even in the presence of a normal laboratory evaluation, GJH can lead to symptoms consistent with a mild bleeding disorder,” she continued. “These symptoms are both preventable and treatable. I’m hopeful more centers will start routinely evaluating for increased bleeding symptoms, with referral to hematology for those with increased bleeding concerns.”

Commenting on the study’s recommendation, Beth S. Gottlieb, MD, chief of the division of pediatric rheumatology at Northwell Health in New Hyde Park, N.Y., who was not involved in the investigation, said a brief questionnaire on bleeding risk is a reasonable addition to a rheumatology office visit.

“Joint hypermobility is very common, but not all affected children meet the criteria for the hypermobile form of hEDS,” she told this news organization. “Screening for bleeding tendency is often done as routine medical history questions. Once a child is identified as hypermobile, these screening questions are usually asked, but utilizing one of the formal bleeding risk questionnaires is not currently routine.”

According to Dr. Gottlieb, it remains unclear whether screening would have a significant impact on children who have been diagnosed with hypermobility. “Most of these children are young and may not yet have a significant history for bleeding tendency,” she said. “Education of families is always important, and it will be essential to educate without adding unnecessary stress. Screening guidelines may be an important tool that is easy to incorporate into routine clinical practice.”
 

Limitation

The study was limited by selection bias, as patients had all been referred to a specialized rheumatology clinic.

The study was supported by the Clinical and Translational Intramural Funding Program of the Abigail Wexner Research Institute. The authors and Dr. Gottlieb have disclosed no relevant financial relationships.

*Correction, 1/11/2023: An earlier version of this story misstated the type of specialty clinic where patients were first seen. 

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

A small cohort study of pediatric rheumatology patients with generalized joint hypermobility (GJH) who presented to a specialized rheumatology* clinic suggests that many such patients have abnormal bleeding symptoms, in comparison with health control patients.

The study of 81 patients with GJH found that about three quarters had significantly elevated median bleeding scores, but only 12% had been assessed by hematology for bleeding.

“We propose that screening for bleeding symptoms should be integrated into the routine care for all patients with GJH, with hematology referrals for patients with increased bleeding concerns,” wrote a research team led by Nicole E. Kendel, MD, a pediatric hematologist-oncologist at Akron Children’s Hospital in Ohio, in a study published online in Arthritis Care and Research.

“Further studies are needed to understand the mechanism of bleeding, evaluate comorbidities associated with these bleeding symptoms, and potentially allow for tailored pharmacologic therapy,” the authors stated.
 

Background

Dr. Kendel’s team had reported moderate menstruation-associated limitations in school, social, and physical activities among female adolescents with GJH. “This cohort also experienced nonreproductive bleeding symptoms and demonstrated minimal hemostatic laboratory abnormalities, indicating that this population may be underdiagnosed and subsequently poorly managed,” she said in an interview. “As excessive bleeding symptoms could have a significant impact on overall health and quality of life, we thought it was important to define the incidence and natural course of bleeding symptoms in a more generalized subset of this population.”

Although the investigators hypothesized that there would be a statistically significant increase in bleeding scores, “we were still impressed by the frequency of abnormal scores, particularly when looking at the low percentage of patients [12%] who had previously been referred to hematology,” she said.
 

Study results

The median age of the study cohort was 13 years (interquartile range, 10-16 years), and 72.8% were female. The mean Beighton score, which measures joint flexibility, was 6.2 (range, 4-9). All participants were seen by rheumatologists and were diagnosed for conditions on the hypermobility spectrum. Those conditions ranged from GJH to hypermobile Ehlers-Danlos syndrome (hEDS).

Abnormal bleeding, as measured by the International Society on Thrombosis and Haemostasis Bleeding Assessment Tool, was found in 75% (95% confidence interval [CI], 64%-84%). Overall mean and median bleeding scores were 5.2 and 4, respectively; scores ranged from 0 to 16. Abnormal scores of ≥ 3 were observed for patients < 8 years of age, ≥ 4 for men ≥ 18 years of age, and ≥ 6 for women ≥ 18 years of age. These measures were significantly elevated compared with those reported for historical healthy pediatric control persons (P < .001).

The most common hemorrhagic symptom was oral bleeding (74.1%) that occurred with tooth brushing, flossing, tooth loss, or eruption. Others reported easy bruising (59.3%) and bleeding from minor wounds (42%). In terms of procedures, tooth extraction requiring additional packing was reported by 25.9%, and 22.2% reported significant bleeding after otolaryngologic procedures, such as tonsillectomy/adenoidectomy, septoplasty, and nasal turbinate reduction.

Prolonged or heavy menstrual periods were reported by 37.3% of female patients.

Bleeding scores did not differ by biological sex or NSAID use, nor did any correlation emerge between patients’ bleeding and Beighton scores. However, there was a positive correlation with increasing age, a phenomenon observed with other bleeding disorders and in the healthy population, the authors noted.

Of the 10 study participants who had previously undergone hematologic assessment, one had been diagnosed with acquired, heart disease–related von Willebrand disease, and another with mild bleeding disorder.

Severe connective tissue disorders are associated with increased bleeding symptoms in the adult population, Dr. Kendel said, but few studies have assessed bleeding across the GJH spectrum, particularly in children.

Bleeding is thought to be due to modifications of collagen in the blood vessels. “These modifications create mechanical weakness of the vessel wall, as well as defective subendothelial connective tissue supporting those blood vessels,” Dr. Kendel explained. She noted that altered collagen creates defective interactions between collagen and other coagulation factors.

“Even in the presence of a normal laboratory evaluation, GJH can lead to symptoms consistent with a mild bleeding disorder,” she continued. “These symptoms are both preventable and treatable. I’m hopeful more centers will start routinely evaluating for increased bleeding symptoms, with referral to hematology for those with increased bleeding concerns.”

Commenting on the study’s recommendation, Beth S. Gottlieb, MD, chief of the division of pediatric rheumatology at Northwell Health in New Hyde Park, N.Y., who was not involved in the investigation, said a brief questionnaire on bleeding risk is a reasonable addition to a rheumatology office visit.

“Joint hypermobility is very common, but not all affected children meet the criteria for the hypermobile form of hEDS,” she told this news organization. “Screening for bleeding tendency is often done as routine medical history questions. Once a child is identified as hypermobile, these screening questions are usually asked, but utilizing one of the formal bleeding risk questionnaires is not currently routine.”

According to Dr. Gottlieb, it remains unclear whether screening would have a significant impact on children who have been diagnosed with hypermobility. “Most of these children are young and may not yet have a significant history for bleeding tendency,” she said. “Education of families is always important, and it will be essential to educate without adding unnecessary stress. Screening guidelines may be an important tool that is easy to incorporate into routine clinical practice.”
 

Limitation

The study was limited by selection bias, as patients had all been referred to a specialized rheumatology clinic.

The study was supported by the Clinical and Translational Intramural Funding Program of the Abigail Wexner Research Institute. The authors and Dr. Gottlieb have disclosed no relevant financial relationships.

*Correction, 1/11/2023: An earlier version of this story misstated the type of specialty clinic where patients were first seen. 

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

A small cohort study of pediatric rheumatology patients with generalized joint hypermobility (GJH) who presented to a specialized rheumatology* clinic suggests that many such patients have abnormal bleeding symptoms, in comparison with health control patients.

The study of 81 patients with GJH found that about three quarters had significantly elevated median bleeding scores, but only 12% had been assessed by hematology for bleeding.

“We propose that screening for bleeding symptoms should be integrated into the routine care for all patients with GJH, with hematology referrals for patients with increased bleeding concerns,” wrote a research team led by Nicole E. Kendel, MD, a pediatric hematologist-oncologist at Akron Children’s Hospital in Ohio, in a study published online in Arthritis Care and Research.

“Further studies are needed to understand the mechanism of bleeding, evaluate comorbidities associated with these bleeding symptoms, and potentially allow for tailored pharmacologic therapy,” the authors stated.
 

Background

Dr. Kendel’s team had reported moderate menstruation-associated limitations in school, social, and physical activities among female adolescents with GJH. “This cohort also experienced nonreproductive bleeding symptoms and demonstrated minimal hemostatic laboratory abnormalities, indicating that this population may be underdiagnosed and subsequently poorly managed,” she said in an interview. “As excessive bleeding symptoms could have a significant impact on overall health and quality of life, we thought it was important to define the incidence and natural course of bleeding symptoms in a more generalized subset of this population.”

Although the investigators hypothesized that there would be a statistically significant increase in bleeding scores, “we were still impressed by the frequency of abnormal scores, particularly when looking at the low percentage of patients [12%] who had previously been referred to hematology,” she said.
 

Study results

The median age of the study cohort was 13 years (interquartile range, 10-16 years), and 72.8% were female. The mean Beighton score, which measures joint flexibility, was 6.2 (range, 4-9). All participants were seen by rheumatologists and were diagnosed for conditions on the hypermobility spectrum. Those conditions ranged from GJH to hypermobile Ehlers-Danlos syndrome (hEDS).

Abnormal bleeding, as measured by the International Society on Thrombosis and Haemostasis Bleeding Assessment Tool, was found in 75% (95% confidence interval [CI], 64%-84%). Overall mean and median bleeding scores were 5.2 and 4, respectively; scores ranged from 0 to 16. Abnormal scores of ≥ 3 were observed for patients < 8 years of age, ≥ 4 for men ≥ 18 years of age, and ≥ 6 for women ≥ 18 years of age. These measures were significantly elevated compared with those reported for historical healthy pediatric control persons (P < .001).

The most common hemorrhagic symptom was oral bleeding (74.1%) that occurred with tooth brushing, flossing, tooth loss, or eruption. Others reported easy bruising (59.3%) and bleeding from minor wounds (42%). In terms of procedures, tooth extraction requiring additional packing was reported by 25.9%, and 22.2% reported significant bleeding after otolaryngologic procedures, such as tonsillectomy/adenoidectomy, septoplasty, and nasal turbinate reduction.

Prolonged or heavy menstrual periods were reported by 37.3% of female patients.

Bleeding scores did not differ by biological sex or NSAID use, nor did any correlation emerge between patients’ bleeding and Beighton scores. However, there was a positive correlation with increasing age, a phenomenon observed with other bleeding disorders and in the healthy population, the authors noted.

Of the 10 study participants who had previously undergone hematologic assessment, one had been diagnosed with acquired, heart disease–related von Willebrand disease, and another with mild bleeding disorder.

Severe connective tissue disorders are associated with increased bleeding symptoms in the adult population, Dr. Kendel said, but few studies have assessed bleeding across the GJH spectrum, particularly in children.

Bleeding is thought to be due to modifications of collagen in the blood vessels. “These modifications create mechanical weakness of the vessel wall, as well as defective subendothelial connective tissue supporting those blood vessels,” Dr. Kendel explained. She noted that altered collagen creates defective interactions between collagen and other coagulation factors.

“Even in the presence of a normal laboratory evaluation, GJH can lead to symptoms consistent with a mild bleeding disorder,” she continued. “These symptoms are both preventable and treatable. I’m hopeful more centers will start routinely evaluating for increased bleeding symptoms, with referral to hematology for those with increased bleeding concerns.”

Commenting on the study’s recommendation, Beth S. Gottlieb, MD, chief of the division of pediatric rheumatology at Northwell Health in New Hyde Park, N.Y., who was not involved in the investigation, said a brief questionnaire on bleeding risk is a reasonable addition to a rheumatology office visit.

“Joint hypermobility is very common, but not all affected children meet the criteria for the hypermobile form of hEDS,” she told this news organization. “Screening for bleeding tendency is often done as routine medical history questions. Once a child is identified as hypermobile, these screening questions are usually asked, but utilizing one of the formal bleeding risk questionnaires is not currently routine.”

According to Dr. Gottlieb, it remains unclear whether screening would have a significant impact on children who have been diagnosed with hypermobility. “Most of these children are young and may not yet have a significant history for bleeding tendency,” she said. “Education of families is always important, and it will be essential to educate without adding unnecessary stress. Screening guidelines may be an important tool that is easy to incorporate into routine clinical practice.”
 

Limitation

The study was limited by selection bias, as patients had all been referred to a specialized rheumatology clinic.

The study was supported by the Clinical and Translational Intramural Funding Program of the Abigail Wexner Research Institute. The authors and Dr. Gottlieb have disclosed no relevant financial relationships.

*Correction, 1/11/2023: An earlier version of this story misstated the type of specialty clinic where patients were first seen. 

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

Telehealth parent-child interaction therapy improved the behavior of 3-year-olds with developmental delay in a randomized controlled trial.

The children received the therapy with their parents or caregivers, who were more likely to demonstrate positive parenting behaviors than parents in the control group, authors of the new research published in JAMA Pediatrics found.

Approximately 13% of children have some form of developmental delay (DD) and more than half of these children also have at least one mental health disorder, which makes behavior problems a common and ongoing challenge, Daniel M. Bagner, PhD, a psychologist at Florida International University, Miami, and colleagues wrote.

Clinic-based interventions such as parent-child interaction therapy (PCIT) have been effective for improving behavior in children with DD, the researchers said. PCIT involves in-session caregiver coaching using a 1-way mirror and a wireless earpiece worn by the caregiver.

Barriers to the use of PCIT, especially in marginalized and low-income communities, include transportation, clinician shortages, and stigma-related concerns about a clinic visit, the researchers wrote. Technology now allows for Internet-delivered PCIT to reach more children and families, but its effectiveness for children with DD has not been well studied.

In the new study, the researchers randomized 150 children with DD and externalizing behavior problems to up to 20 weeks of Internet-delivered parent-child interaction therapy (iPCIT) or to referral as usual (RAU, the control group). The children were randomized after completion of early intervention services within 3 months of their third birthday, and participated in the sessions with a parent or caregiver. Most of the participants were from economically disadvantaged households and underrepresented ethnic backgrounds.

The iPCIT intervention was conducted weekly with a remote therapist and lasted for 1-1.5 hours; approximately half of the families received the intervention in Spanish.

The primary outcome was rating on the Child Behavior Checklist (CBCL) and assessment of children and caregivers using the Dyadic Parent-Child Interaction Coding System, fourth edition (DPICS). Assessments occurred at baseline and at week 20 (post treatment), with follow ups at 6 and 12 months.

Scores on the CBCL in the iPCIT group decreased from a mean of 61.18 at baseline to 53.83 post intervention. Scores for the control group started at 64.05 and decreased to 59.49 post intervention. At 6-12 months, the scores for both groups remained stable.

Children who received iPCIT with their parent or caregiver also showed significantly lower levels of externalizing behavior problems, compared with the RAU controls post treatment, and at 6-month and 12-month follow-ups based on the Cohen d measure of standardized effect size for differences between groups.

Significantly more children in the iPCIT group showed clinically significant improvements in externalizing problems at post treatment, compared with the RAU group (74% vs. 42%; P < .001) and at 6 months’ follow-up (73% vs. 45%; P = .002). However, the differences from baseline were not significantly different between the two groups after 12 months, which suggests that the effects may wane over time, the researchers noted.

In addition, the rate of child compliance with parent commands, as measured by a cleanup task, approximately doubled by the 12-month follow-up among children in the iPCIT group versus an increase of approximately one-third in the RAU group.

For secondary outcome measures related to caregiver behaviors, the proportion of observed positive parenting behaviors increased in the iPCIT group during the course of the intervention (postintervention odds ratio, 1.10), and the proportion of controlling and critical behaviors decreased (postintervention OR, 1.40). Harsh and inconsistent discipline decreased in both groups based on self-reports, but the decrease was steeper in iPCIT families.

iPCIT did not have a greater impact than RAU in reducing caregiver stress. The researchers wrote that they were not surprised by the lack of stress reduction “given mixed findings on the impact of parenting interventions on stress in caregivers of children with DD.”
 

Data support iPCIT potential

Overall, the results support findings from previous studies of clinic-based PCIT for children with DD and previous studies of telehealth interventions for typically developing children, the researchers said.

“Moreover, iPCIT-treated children not only showed reductions in behavior problems, such as aggression, but demonstrated higher rates of following directions, which is especially important for children entering kindergarten,” they wrote.

The findings were limited by several factors including the narrow focus on the primary and secondary outcomes, the use of data from a single site in a single metropolitan area – which may limit generalizability – and the lack of comparison between iPCIT and a clinic-based PCIT control group, the researchers noted. The equipment in the current study was provided to families; therefore, differences in treatment response could not be attributed to differences in technology.

The study represents the first known randomized controlled trial to evaluate a telehealth parenting intervention for children with, according to the researchers. The results suggest that technology can be leveraged to help these patients, including those from ethnic minority families who may be underserved by clinic-based care in overcoming barriers to treatment such as transportation and availability of clinicians. Use of iPCIT could be a critical resource as young children with DD complete Part C services and enter the school system.
 

Practical pediatric takeaways

“This was a great study, well-designed and very important and helpful for pediatric providers,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Young children with developmental delay and/or mental and behavioral health disorders require early identification and intervention,” said Dr. Haut. However, obstacles to intervention include stigma or parental denial of the disorder, as well as more practical challenges related to transportation, time to access a clinic or office, potential long length of treatment, and cost.

“Despite availability of state programs for young children, follow up and continued services can be challenging to complete. Once the child outgrows the state program finding alternative therapy can be difficult with the current shortage of pediatric mental health providers,” Dr. Haut noted.

“I was surprised to see that this study treatment phase was completed prior to the COVID-19 pandemic, when telehealth was not as popular a mode for health care and was not utilized to the extent that it is now, especially for pediatric care,” said Dr. Haut. “I was not surprised at the results, as the traditional mode of PCIT includes therapy and training in a space that may not be as familiar to the child as their home environment, and would include live presence of the therapist/s, which may add to anxiety for both the parent and child.”

That almost half of the parents participating in the study had graduated from college and/or completed graduate degrees “may have contributed to some of the success of this study,” Dr. Haut noted.
 

Benefits and barriers

“The COVID-19 pandemic brought significant change to the frequency of use and overall success of telehealth services,” Dr. Haut said. “Additional provider education in aspects such as provider technique and the use of medical devices with improved specific health care technology assisted in advancing the experience and opportunity for successful telehealth visits. Telehealth therapy offers a cost-effective option for any pediatric patients and for providers, as the time and space commitment for the patient visit can be considerably less than live office visits.

“Unfortunately, there are still overall barriers that I have personally experienced with telehealth, including interruptions in connectivity, background noise, and lack of an available computer or tablet; and with the use of cell phones not always allowing full inclusion of the caregiver and child,” said Dr. Haut. Children with DD, behavioral problems, or other mental health disorders may pose challenges for parents to manage at home while simultaneously trying to fully focus on the therapy in an online setting.

Although the current study is encouraging, “larger studies focused on specific or individual pediatric mental health and/or behavioral disorders may offer more information for providers, and better document the success of telehealth delivery of services,” Dr. Haut said.

The study was supported by the National Institute of Child Health and Human Development. Dr. Bagner disclosed funding from the National Institutes of Health. He also disclosed personal fees from PCIT International to train clinicians in PCIT supported by a grant from the Florida Department of Children and Families outside the current study. Dr. Haut had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.

Telehealth parent-child interaction therapy improved the behavior of 3-year-olds with developmental delay in a randomized controlled trial.

The children received the therapy with their parents or caregivers, who were more likely to demonstrate positive parenting behaviors than parents in the control group, authors of the new research published in JAMA Pediatrics found.

Approximately 13% of children have some form of developmental delay (DD) and more than half of these children also have at least one mental health disorder, which makes behavior problems a common and ongoing challenge, Daniel M. Bagner, PhD, a psychologist at Florida International University, Miami, and colleagues wrote.

Clinic-based interventions such as parent-child interaction therapy (PCIT) have been effective for improving behavior in children with DD, the researchers said. PCIT involves in-session caregiver coaching using a 1-way mirror and a wireless earpiece worn by the caregiver.

Barriers to the use of PCIT, especially in marginalized and low-income communities, include transportation, clinician shortages, and stigma-related concerns about a clinic visit, the researchers wrote. Technology now allows for Internet-delivered PCIT to reach more children and families, but its effectiveness for children with DD has not been well studied.

In the new study, the researchers randomized 150 children with DD and externalizing behavior problems to up to 20 weeks of Internet-delivered parent-child interaction therapy (iPCIT) or to referral as usual (RAU, the control group). The children were randomized after completion of early intervention services within 3 months of their third birthday, and participated in the sessions with a parent or caregiver. Most of the participants were from economically disadvantaged households and underrepresented ethnic backgrounds.

The iPCIT intervention was conducted weekly with a remote therapist and lasted for 1-1.5 hours; approximately half of the families received the intervention in Spanish.

The primary outcome was rating on the Child Behavior Checklist (CBCL) and assessment of children and caregivers using the Dyadic Parent-Child Interaction Coding System, fourth edition (DPICS). Assessments occurred at baseline and at week 20 (post treatment), with follow ups at 6 and 12 months.

Scores on the CBCL in the iPCIT group decreased from a mean of 61.18 at baseline to 53.83 post intervention. Scores for the control group started at 64.05 and decreased to 59.49 post intervention. At 6-12 months, the scores for both groups remained stable.

Children who received iPCIT with their parent or caregiver also showed significantly lower levels of externalizing behavior problems, compared with the RAU controls post treatment, and at 6-month and 12-month follow-ups based on the Cohen d measure of standardized effect size for differences between groups.

Significantly more children in the iPCIT group showed clinically significant improvements in externalizing problems at post treatment, compared with the RAU group (74% vs. 42%; P < .001) and at 6 months’ follow-up (73% vs. 45%; P = .002). However, the differences from baseline were not significantly different between the two groups after 12 months, which suggests that the effects may wane over time, the researchers noted.

In addition, the rate of child compliance with parent commands, as measured by a cleanup task, approximately doubled by the 12-month follow-up among children in the iPCIT group versus an increase of approximately one-third in the RAU group.

For secondary outcome measures related to caregiver behaviors, the proportion of observed positive parenting behaviors increased in the iPCIT group during the course of the intervention (postintervention odds ratio, 1.10), and the proportion of controlling and critical behaviors decreased (postintervention OR, 1.40). Harsh and inconsistent discipline decreased in both groups based on self-reports, but the decrease was steeper in iPCIT families.

iPCIT did not have a greater impact than RAU in reducing caregiver stress. The researchers wrote that they were not surprised by the lack of stress reduction “given mixed findings on the impact of parenting interventions on stress in caregivers of children with DD.”
 

Data support iPCIT potential

Overall, the results support findings from previous studies of clinic-based PCIT for children with DD and previous studies of telehealth interventions for typically developing children, the researchers said.

“Moreover, iPCIT-treated children not only showed reductions in behavior problems, such as aggression, but demonstrated higher rates of following directions, which is especially important for children entering kindergarten,” they wrote.

The findings were limited by several factors including the narrow focus on the primary and secondary outcomes, the use of data from a single site in a single metropolitan area – which may limit generalizability – and the lack of comparison between iPCIT and a clinic-based PCIT control group, the researchers noted. The equipment in the current study was provided to families; therefore, differences in treatment response could not be attributed to differences in technology.

The study represents the first known randomized controlled trial to evaluate a telehealth parenting intervention for children with, according to the researchers. The results suggest that technology can be leveraged to help these patients, including those from ethnic minority families who may be underserved by clinic-based care in overcoming barriers to treatment such as transportation and availability of clinicians. Use of iPCIT could be a critical resource as young children with DD complete Part C services and enter the school system.
 

Practical pediatric takeaways

“This was a great study, well-designed and very important and helpful for pediatric providers,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Young children with developmental delay and/or mental and behavioral health disorders require early identification and intervention,” said Dr. Haut. However, obstacles to intervention include stigma or parental denial of the disorder, as well as more practical challenges related to transportation, time to access a clinic or office, potential long length of treatment, and cost.

“Despite availability of state programs for young children, follow up and continued services can be challenging to complete. Once the child outgrows the state program finding alternative therapy can be difficult with the current shortage of pediatric mental health providers,” Dr. Haut noted.

“I was surprised to see that this study treatment phase was completed prior to the COVID-19 pandemic, when telehealth was not as popular a mode for health care and was not utilized to the extent that it is now, especially for pediatric care,” said Dr. Haut. “I was not surprised at the results, as the traditional mode of PCIT includes therapy and training in a space that may not be as familiar to the child as their home environment, and would include live presence of the therapist/s, which may add to anxiety for both the parent and child.”

That almost half of the parents participating in the study had graduated from college and/or completed graduate degrees “may have contributed to some of the success of this study,” Dr. Haut noted.
 

Benefits and barriers

“The COVID-19 pandemic brought significant change to the frequency of use and overall success of telehealth services,” Dr. Haut said. “Additional provider education in aspects such as provider technique and the use of medical devices with improved specific health care technology assisted in advancing the experience and opportunity for successful telehealth visits. Telehealth therapy offers a cost-effective option for any pediatric patients and for providers, as the time and space commitment for the patient visit can be considerably less than live office visits.

“Unfortunately, there are still overall barriers that I have personally experienced with telehealth, including interruptions in connectivity, background noise, and lack of an available computer or tablet; and with the use of cell phones not always allowing full inclusion of the caregiver and child,” said Dr. Haut. Children with DD, behavioral problems, or other mental health disorders may pose challenges for parents to manage at home while simultaneously trying to fully focus on the therapy in an online setting.

Although the current study is encouraging, “larger studies focused on specific or individual pediatric mental health and/or behavioral disorders may offer more information for providers, and better document the success of telehealth delivery of services,” Dr. Haut said.

The study was supported by the National Institute of Child Health and Human Development. Dr. Bagner disclosed funding from the National Institutes of Health. He also disclosed personal fees from PCIT International to train clinicians in PCIT supported by a grant from the Florida Department of Children and Families outside the current study. Dr. Haut had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.

Telehealth parent-child interaction therapy improved the behavior of 3-year-olds with developmental delay in a randomized controlled trial.

The children received the therapy with their parents or caregivers, who were more likely to demonstrate positive parenting behaviors than parents in the control group, authors of the new research published in JAMA Pediatrics found.

Approximately 13% of children have some form of developmental delay (DD) and more than half of these children also have at least one mental health disorder, which makes behavior problems a common and ongoing challenge, Daniel M. Bagner, PhD, a psychologist at Florida International University, Miami, and colleagues wrote.

Clinic-based interventions such as parent-child interaction therapy (PCIT) have been effective for improving behavior in children with DD, the researchers said. PCIT involves in-session caregiver coaching using a 1-way mirror and a wireless earpiece worn by the caregiver.

Barriers to the use of PCIT, especially in marginalized and low-income communities, include transportation, clinician shortages, and stigma-related concerns about a clinic visit, the researchers wrote. Technology now allows for Internet-delivered PCIT to reach more children and families, but its effectiveness for children with DD has not been well studied.

In the new study, the researchers randomized 150 children with DD and externalizing behavior problems to up to 20 weeks of Internet-delivered parent-child interaction therapy (iPCIT) or to referral as usual (RAU, the control group). The children were randomized after completion of early intervention services within 3 months of their third birthday, and participated in the sessions with a parent or caregiver. Most of the participants were from economically disadvantaged households and underrepresented ethnic backgrounds.

The iPCIT intervention was conducted weekly with a remote therapist and lasted for 1-1.5 hours; approximately half of the families received the intervention in Spanish.

The primary outcome was rating on the Child Behavior Checklist (CBCL) and assessment of children and caregivers using the Dyadic Parent-Child Interaction Coding System, fourth edition (DPICS). Assessments occurred at baseline and at week 20 (post treatment), with follow ups at 6 and 12 months.

Scores on the CBCL in the iPCIT group decreased from a mean of 61.18 at baseline to 53.83 post intervention. Scores for the control group started at 64.05 and decreased to 59.49 post intervention. At 6-12 months, the scores for both groups remained stable.

Children who received iPCIT with their parent or caregiver also showed significantly lower levels of externalizing behavior problems, compared with the RAU controls post treatment, and at 6-month and 12-month follow-ups based on the Cohen d measure of standardized effect size for differences between groups.

Significantly more children in the iPCIT group showed clinically significant improvements in externalizing problems at post treatment, compared with the RAU group (74% vs. 42%; P < .001) and at 6 months’ follow-up (73% vs. 45%; P = .002). However, the differences from baseline were not significantly different between the two groups after 12 months, which suggests that the effects may wane over time, the researchers noted.

In addition, the rate of child compliance with parent commands, as measured by a cleanup task, approximately doubled by the 12-month follow-up among children in the iPCIT group versus an increase of approximately one-third in the RAU group.

For secondary outcome measures related to caregiver behaviors, the proportion of observed positive parenting behaviors increased in the iPCIT group during the course of the intervention (postintervention odds ratio, 1.10), and the proportion of controlling and critical behaviors decreased (postintervention OR, 1.40). Harsh and inconsistent discipline decreased in both groups based on self-reports, but the decrease was steeper in iPCIT families.

iPCIT did not have a greater impact than RAU in reducing caregiver stress. The researchers wrote that they were not surprised by the lack of stress reduction “given mixed findings on the impact of parenting interventions on stress in caregivers of children with DD.”
 

Data support iPCIT potential

Overall, the results support findings from previous studies of clinic-based PCIT for children with DD and previous studies of telehealth interventions for typically developing children, the researchers said.

“Moreover, iPCIT-treated children not only showed reductions in behavior problems, such as aggression, but demonstrated higher rates of following directions, which is especially important for children entering kindergarten,” they wrote.

The findings were limited by several factors including the narrow focus on the primary and secondary outcomes, the use of data from a single site in a single metropolitan area – which may limit generalizability – and the lack of comparison between iPCIT and a clinic-based PCIT control group, the researchers noted. The equipment in the current study was provided to families; therefore, differences in treatment response could not be attributed to differences in technology.

The study represents the first known randomized controlled trial to evaluate a telehealth parenting intervention for children with, according to the researchers. The results suggest that technology can be leveraged to help these patients, including those from ethnic minority families who may be underserved by clinic-based care in overcoming barriers to treatment such as transportation and availability of clinicians. Use of iPCIT could be a critical resource as young children with DD complete Part C services and enter the school system.
 

Practical pediatric takeaways

“This was a great study, well-designed and very important and helpful for pediatric providers,” Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.

“Young children with developmental delay and/or mental and behavioral health disorders require early identification and intervention,” said Dr. Haut. However, obstacles to intervention include stigma or parental denial of the disorder, as well as more practical challenges related to transportation, time to access a clinic or office, potential long length of treatment, and cost.

“Despite availability of state programs for young children, follow up and continued services can be challenging to complete. Once the child outgrows the state program finding alternative therapy can be difficult with the current shortage of pediatric mental health providers,” Dr. Haut noted.

“I was surprised to see that this study treatment phase was completed prior to the COVID-19 pandemic, when telehealth was not as popular a mode for health care and was not utilized to the extent that it is now, especially for pediatric care,” said Dr. Haut. “I was not surprised at the results, as the traditional mode of PCIT includes therapy and training in a space that may not be as familiar to the child as their home environment, and would include live presence of the therapist/s, which may add to anxiety for both the parent and child.”

That almost half of the parents participating in the study had graduated from college and/or completed graduate degrees “may have contributed to some of the success of this study,” Dr. Haut noted.
 

Benefits and barriers

“The COVID-19 pandemic brought significant change to the frequency of use and overall success of telehealth services,” Dr. Haut said. “Additional provider education in aspects such as provider technique and the use of medical devices with improved specific health care technology assisted in advancing the experience and opportunity for successful telehealth visits. Telehealth therapy offers a cost-effective option for any pediatric patients and for providers, as the time and space commitment for the patient visit can be considerably less than live office visits.

“Unfortunately, there are still overall barriers that I have personally experienced with telehealth, including interruptions in connectivity, background noise, and lack of an available computer or tablet; and with the use of cell phones not always allowing full inclusion of the caregiver and child,” said Dr. Haut. Children with DD, behavioral problems, or other mental health disorders may pose challenges for parents to manage at home while simultaneously trying to fully focus on the therapy in an online setting.

Although the current study is encouraging, “larger studies focused on specific or individual pediatric mental health and/or behavioral disorders may offer more information for providers, and better document the success of telehealth delivery of services,” Dr. Haut said.

The study was supported by the National Institute of Child Health and Human Development. Dr. Bagner disclosed funding from the National Institutes of Health. He also disclosed personal fees from PCIT International to train clinicians in PCIT supported by a grant from the Florida Department of Children and Families outside the current study. Dr. Haut had no financial conflicts to disclose, but serves on the editorial advisory board of Pediatric News.