Heidi Splete

About 22% of children with COVID-19 infections were asymptomatic, and 66% of the symptomatic children had unrecognized symptoms at the time of diagnosis, based on data from a case series of 91 confirmed cases.

South_agency/Getty Images

Although recent reports suggest that COVID-19 infections in children are generally mild, data on the full spectrum of illness and duration of viral RNA in children are limited, wrote Mi Seon Han, MD, PhD, of Seoul (South Korea) Metropolitan Government–Seoul National University Boramae Medical Center, and colleagues.

To examine the full clinical course and duration of COVID-19 RNA detectability in children with confirmed infections, the researchers reviewed data from 91 individuals with confirmed infections. The children ranged in age from 27 days to 18 years, and 58% were male. The children were monitored at 20 hospitals and 2 isolation facilities for a mean 21.9 days. The findings were published in JAMA Pediatrics.

Overall, COVID-19 viral RNA was present in the study population for a mean 17.6 days, with testing done at a median interval of 3 days. A total of 20 children (22%) were asymptomatic throughout the study period. In these children, viral RNA was detected for a mean 14 days.

“The major hurdle implicated in this study in diagnosing and treating children with COVID-19 is that a considerable number of children are asymptomatic, and even if symptoms are present, they are unrecognized and overlooked before COVID-19 is diagnosed,” the researchers noted.

Of the 71 symptomatic children, 47 (66%) had unrecognized symptoms prior to diagnosis, 18 (25%) developed symptoms after diagnosis, and 6 (9%) were diagnosed at the time of symptom onset. The symptomatic children were symptomatic for a median of 11 days; 43 (61%) remained symptomatic at 7 days’ follow-up after the study period, 27 (38%) were symptomatic at 14 days, and 7 (10%) were symptomatic at 21 days.

A total of 41 children had upper respiratory infections (58%) and 22 children (24%) had lower respiratory tract infections. No difference in the duration of virus RNA was detected between children with upper respiratory tract infections and lower respiratory tract infections (average, 18.7 days vs. 19.9 days).

Among the symptomatic children, 46 (65%) had mild cases and 20 (28%) had moderate cases.

For treatment, 14 children (15%) received lopinavir-ritonavir and/or hydroxychloroquine. Two patients had severe illness and received oxygen via nasal prong, without the need for mechanical ventilation. All the children in the case series recovered from their infections with no fatalities.

The study’s main limitation was the inability to analyze the transmission potential of the children because of the quarantine and isolation policies in Korea, the researchers noted. In addition, the researchers did not perform follow-up testing at consistent intervals, so the duration of COVID-19 RNA detection may be inexact.

However, the results suggest “that suspecting and diagnosing COVID-19 in children based on their symptoms without epidemiologic information and virus testing is very challenging,” the researchers emphasized.

“Most of the children with COVID-19 have silent disease, but SARS-CoV-2 RNA can still be detected in the respiratory tract for a prolonged period,” they wrote. More research is needed to explore the potential for disease transmission by children in the community, and increased surveillance with laboratory screening can help identify children with unrecognized infections.

The study is the first known to focus on the frequency of asymptomatic infection in children and the duration of symptoms in both asymptomatic and symptomatic children, Roberta L. DeBiasi, MD, and Meghan Delaney, DO, both affiliated with Children’s National Hospital and Research Institute, Washington, and George Washington University, Washington, wrote in an accompanying editorial. The structure of the Korean public health system “allowed for the sequential observation, testing (median testing interval of every 3 days), and comparison of 91 asymptomatic, presymptomatic, and symptomatic children with mild to moderate upper and lower respiratory tract infection, identified primarily by contact tracing from laboratory-proven cases.”

Two take-home points from the study are that not all infected children are symptomatic, and the duration of symptoms in those who are varies widely, they noted. “Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection.”

However, “The third and most important take-home point from this study relates to the duration of viral shedding in infected pediatric patients,” Dr. DeBiasi and Dr. Delaney said (JAMA Pediatr. 2020 Aug 28. doi: 10.1001/jamapediatrics.2020.3996).

“Fully half of symptomatic children with both upper and lower tract disease were still shedding virus at 21 days. These are striking data, particularly since 86 of 88 diagnosed children (98%) either had no symptoms or mild or moderate disease,” they explained. The results highlight the need for improvements in qualitative molecular testing and formal studies to identify differences in results from different testing scenarios, such as hospital entry, preprocedure screening, and symptomatic testing. In addition, “these findings are highly relevant to the development of public health strategies to mitigate and contain spread within communities, particularly as affected communities begin their recovery phases.”

The study is important because “schools are opening, and we don’t know what is going to happen,” Michael E. Pichichero, MD, of Rochester General Hospital, N.Y., said in an interview.

“Clinicians, parents, students, school administrators and politicians are worried,” he said. “This study adds to others recently published, bringing into focus the challenges to several suppositions that existed when the COVID-19 pandemic began and over the summer.”

“This study of 91 Korean children tells us that taking a child’s temperature as a screening tool to decide if they may enter school will not be a highly successful strategy,” he said. “Many children are without fever and asymptomatic when infected and contagious. The notion that children shed less virus or shed it for shorter lengths of time we keep learning from this type of research is not true. In another recent study the authors found that children shed as much of the SARS-CoV-2 virus as an adult in the ICU on a ventilator.”

Dr. Pichichero said he was not surprised by the study findings. “A similar paper was published last week in the Journal of Pediatrics from Massachusetts General Hospital, so the findings in the JAMA paper are similar to what has been reported in the United States.”

“Availability of testing will continue to be a challenge in some communities,” said Dr. Pichichero. “Here in the Rochester, New York, area we will use a screening questionnaire based on the CDC [Centers for Disease Control and Prevention] symptom criteria of SARS-CoV-2 infections to decide whom to test.”

As for additional research, “We have so much more to learn about SARS-CoV-2 in children,” he emphasized. “The focus has been on adults because the morbidity and mortality has been greatest in adults, especially the elderly and those with compromised health.”

“The National Institutes of Health has issued a call for more research in children to characterize the spectrum of SARS-CoV-2 illness, including the multisystem inflammatory syndrome in children [MIS-C] and try to identify biomarkers and/or biosignatures for a prognostic algorithm to predict the longitudinal risk of disease severity after a child is exposed to and may be infected with SARS-CoV-2,” said Dr. Pichichero. “NIH has asked researchers to answer the following questions.”

• Why do children have milder illness?
• Are there differences in childhood biology (e.g., gender, puberty, etc.) that contribute to illness severity?
• Are there genetic host differences associated with different disease severity phenotypes, including MIS-C?
• Are there innate mucosal, humoral, cellular and other adaptive immune profiles that are associated with reduced or increased risk of progressive disease, including previous coronavirus infections?
• Will SARS-CoV-2 reinfection cause worse disease as seen with antibody-dependent enhancement (ADE) in other viral infections (e.g., dengue)? Will future vaccines carry a risk of the ADE phenomenon?
• Does substance use (e.g., nicotine, marijuana) exacerbate or trigger MIS-C through immune activation?

“We have no knowledge yet about SARS-CoV-2 vaccination of children, especially young children,” Dr. Pichichero emphasized. “There are different types of vaccines – messenger RNA, adenovirus vector and purified spike proteins of the virus – among others, but questions remain: Will the vaccines work in children? What about side effects? Will the antibodies and cellular immunity protect partially or completely?”

The researchers and editorialists had no financial conflicts to disclose. Dr. Pichichero had no financial conflicts to disclose.

SOURCE: Han MS et al. JAMA Pediatr. 2020 Aug 28. doi:10.1001/jamapediatrics.2020.3988.

About 22% of children with COVID-19 infections were asymptomatic, and 66% of the symptomatic children had unrecognized symptoms at the time of diagnosis, based on data from a case series of 91 confirmed cases.

South_agency/Getty Images

Although recent reports suggest that COVID-19 infections in children are generally mild, data on the full spectrum of illness and duration of viral RNA in children are limited, wrote Mi Seon Han, MD, PhD, of Seoul (South Korea) Metropolitan Government–Seoul National University Boramae Medical Center, and colleagues.

To examine the full clinical course and duration of COVID-19 RNA detectability in children with confirmed infections, the researchers reviewed data from 91 individuals with confirmed infections. The children ranged in age from 27 days to 18 years, and 58% were male. The children were monitored at 20 hospitals and 2 isolation facilities for a mean 21.9 days. The findings were published in JAMA Pediatrics.

Overall, COVID-19 viral RNA was present in the study population for a mean 17.6 days, with testing done at a median interval of 3 days. A total of 20 children (22%) were asymptomatic throughout the study period. In these children, viral RNA was detected for a mean 14 days.

“The major hurdle implicated in this study in diagnosing and treating children with COVID-19 is that a considerable number of children are asymptomatic, and even if symptoms are present, they are unrecognized and overlooked before COVID-19 is diagnosed,” the researchers noted.

Of the 71 symptomatic children, 47 (66%) had unrecognized symptoms prior to diagnosis, 18 (25%) developed symptoms after diagnosis, and 6 (9%) were diagnosed at the time of symptom onset. The symptomatic children were symptomatic for a median of 11 days; 43 (61%) remained symptomatic at 7 days’ follow-up after the study period, 27 (38%) were symptomatic at 14 days, and 7 (10%) were symptomatic at 21 days.

A total of 41 children had upper respiratory infections (58%) and 22 children (24%) had lower respiratory tract infections. No difference in the duration of virus RNA was detected between children with upper respiratory tract infections and lower respiratory tract infections (average, 18.7 days vs. 19.9 days).

Among the symptomatic children, 46 (65%) had mild cases and 20 (28%) had moderate cases.

For treatment, 14 children (15%) received lopinavir-ritonavir and/or hydroxychloroquine. Two patients had severe illness and received oxygen via nasal prong, without the need for mechanical ventilation. All the children in the case series recovered from their infections with no fatalities.

The study’s main limitation was the inability to analyze the transmission potential of the children because of the quarantine and isolation policies in Korea, the researchers noted. In addition, the researchers did not perform follow-up testing at consistent intervals, so the duration of COVID-19 RNA detection may be inexact.

However, the results suggest “that suspecting and diagnosing COVID-19 in children based on their symptoms without epidemiologic information and virus testing is very challenging,” the researchers emphasized.

“Most of the children with COVID-19 have silent disease, but SARS-CoV-2 RNA can still be detected in the respiratory tract for a prolonged period,” they wrote. More research is needed to explore the potential for disease transmission by children in the community, and increased surveillance with laboratory screening can help identify children with unrecognized infections.

The study is the first known to focus on the frequency of asymptomatic infection in children and the duration of symptoms in both asymptomatic and symptomatic children, Roberta L. DeBiasi, MD, and Meghan Delaney, DO, both affiliated with Children’s National Hospital and Research Institute, Washington, and George Washington University, Washington, wrote in an accompanying editorial. The structure of the Korean public health system “allowed for the sequential observation, testing (median testing interval of every 3 days), and comparison of 91 asymptomatic, presymptomatic, and symptomatic children with mild to moderate upper and lower respiratory tract infection, identified primarily by contact tracing from laboratory-proven cases.”

Two take-home points from the study are that not all infected children are symptomatic, and the duration of symptoms in those who are varies widely, they noted. “Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection.”

However, “The third and most important take-home point from this study relates to the duration of viral shedding in infected pediatric patients,” Dr. DeBiasi and Dr. Delaney said (JAMA Pediatr. 2020 Aug 28. doi: 10.1001/jamapediatrics.2020.3996).

“Fully half of symptomatic children with both upper and lower tract disease were still shedding virus at 21 days. These are striking data, particularly since 86 of 88 diagnosed children (98%) either had no symptoms or mild or moderate disease,” they explained. The results highlight the need for improvements in qualitative molecular testing and formal studies to identify differences in results from different testing scenarios, such as hospital entry, preprocedure screening, and symptomatic testing. In addition, “these findings are highly relevant to the development of public health strategies to mitigate and contain spread within communities, particularly as affected communities begin their recovery phases.”

The study is important because “schools are opening, and we don’t know what is going to happen,” Michael E. Pichichero, MD, of Rochester General Hospital, N.Y., said in an interview.

“Clinicians, parents, students, school administrators and politicians are worried,” he said. “This study adds to others recently published, bringing into focus the challenges to several suppositions that existed when the COVID-19 pandemic began and over the summer.”

“This study of 91 Korean children tells us that taking a child’s temperature as a screening tool to decide if they may enter school will not be a highly successful strategy,” he said. “Many children are without fever and asymptomatic when infected and contagious. The notion that children shed less virus or shed it for shorter lengths of time we keep learning from this type of research is not true. In another recent study the authors found that children shed as much of the SARS-CoV-2 virus as an adult in the ICU on a ventilator.”

Dr. Pichichero said he was not surprised by the study findings. “A similar paper was published last week in the Journal of Pediatrics from Massachusetts General Hospital, so the findings in the JAMA paper are similar to what has been reported in the United States.”

“Availability of testing will continue to be a challenge in some communities,” said Dr. Pichichero. “Here in the Rochester, New York, area we will use a screening questionnaire based on the CDC [Centers for Disease Control and Prevention] symptom criteria of SARS-CoV-2 infections to decide whom to test.”

As for additional research, “We have so much more to learn about SARS-CoV-2 in children,” he emphasized. “The focus has been on adults because the morbidity and mortality has been greatest in adults, especially the elderly and those with compromised health.”

“The National Institutes of Health has issued a call for more research in children to characterize the spectrum of SARS-CoV-2 illness, including the multisystem inflammatory syndrome in children [MIS-C] and try to identify biomarkers and/or biosignatures for a prognostic algorithm to predict the longitudinal risk of disease severity after a child is exposed to and may be infected with SARS-CoV-2,” said Dr. Pichichero. “NIH has asked researchers to answer the following questions.”

• Why do children have milder illness?
• Are there differences in childhood biology (e.g., gender, puberty, etc.) that contribute to illness severity?
• Are there genetic host differences associated with different disease severity phenotypes, including MIS-C?
• Are there innate mucosal, humoral, cellular and other adaptive immune profiles that are associated with reduced or increased risk of progressive disease, including previous coronavirus infections?
• Will SARS-CoV-2 reinfection cause worse disease as seen with antibody-dependent enhancement (ADE) in other viral infections (e.g., dengue)? Will future vaccines carry a risk of the ADE phenomenon?
• Does substance use (e.g., nicotine, marijuana) exacerbate or trigger MIS-C through immune activation?

“We have no knowledge yet about SARS-CoV-2 vaccination of children, especially young children,” Dr. Pichichero emphasized. “There are different types of vaccines – messenger RNA, adenovirus vector and purified spike proteins of the virus – among others, but questions remain: Will the vaccines work in children? What about side effects? Will the antibodies and cellular immunity protect partially or completely?”

The researchers and editorialists had no financial conflicts to disclose. Dr. Pichichero had no financial conflicts to disclose.

SOURCE: Han MS et al. JAMA Pediatr. 2020 Aug 28. doi:10.1001/jamapediatrics.2020.3988.

About 22% of children with COVID-19 infections were asymptomatic, and 66% of the symptomatic children had unrecognized symptoms at the time of diagnosis, based on data from a case series of 91 confirmed cases.

South_agency/Getty Images

Although recent reports suggest that COVID-19 infections in children are generally mild, data on the full spectrum of illness and duration of viral RNA in children are limited, wrote Mi Seon Han, MD, PhD, of Seoul (South Korea) Metropolitan Government–Seoul National University Boramae Medical Center, and colleagues.

To examine the full clinical course and duration of COVID-19 RNA detectability in children with confirmed infections, the researchers reviewed data from 91 individuals with confirmed infections. The children ranged in age from 27 days to 18 years, and 58% were male. The children were monitored at 20 hospitals and 2 isolation facilities for a mean 21.9 days. The findings were published in JAMA Pediatrics.

Overall, COVID-19 viral RNA was present in the study population for a mean 17.6 days, with testing done at a median interval of 3 days. A total of 20 children (22%) were asymptomatic throughout the study period. In these children, viral RNA was detected for a mean 14 days.

“The major hurdle implicated in this study in diagnosing and treating children with COVID-19 is that a considerable number of children are asymptomatic, and even if symptoms are present, they are unrecognized and overlooked before COVID-19 is diagnosed,” the researchers noted.

Of the 71 symptomatic children, 47 (66%) had unrecognized symptoms prior to diagnosis, 18 (25%) developed symptoms after diagnosis, and 6 (9%) were diagnosed at the time of symptom onset. The symptomatic children were symptomatic for a median of 11 days; 43 (61%) remained symptomatic at 7 days’ follow-up after the study period, 27 (38%) were symptomatic at 14 days, and 7 (10%) were symptomatic at 21 days.

A total of 41 children had upper respiratory infections (58%) and 22 children (24%) had lower respiratory tract infections. No difference in the duration of virus RNA was detected between children with upper respiratory tract infections and lower respiratory tract infections (average, 18.7 days vs. 19.9 days).

Among the symptomatic children, 46 (65%) had mild cases and 20 (28%) had moderate cases.

For treatment, 14 children (15%) received lopinavir-ritonavir and/or hydroxychloroquine. Two patients had severe illness and received oxygen via nasal prong, without the need for mechanical ventilation. All the children in the case series recovered from their infections with no fatalities.

The study’s main limitation was the inability to analyze the transmission potential of the children because of the quarantine and isolation policies in Korea, the researchers noted. In addition, the researchers did not perform follow-up testing at consistent intervals, so the duration of COVID-19 RNA detection may be inexact.

However, the results suggest “that suspecting and diagnosing COVID-19 in children based on their symptoms without epidemiologic information and virus testing is very challenging,” the researchers emphasized.

“Most of the children with COVID-19 have silent disease, but SARS-CoV-2 RNA can still be detected in the respiratory tract for a prolonged period,” they wrote. More research is needed to explore the potential for disease transmission by children in the community, and increased surveillance with laboratory screening can help identify children with unrecognized infections.

The study is the first known to focus on the frequency of asymptomatic infection in children and the duration of symptoms in both asymptomatic and symptomatic children, Roberta L. DeBiasi, MD, and Meghan Delaney, DO, both affiliated with Children’s National Hospital and Research Institute, Washington, and George Washington University, Washington, wrote in an accompanying editorial. The structure of the Korean public health system “allowed for the sequential observation, testing (median testing interval of every 3 days), and comparison of 91 asymptomatic, presymptomatic, and symptomatic children with mild to moderate upper and lower respiratory tract infection, identified primarily by contact tracing from laboratory-proven cases.”

Two take-home points from the study are that not all infected children are symptomatic, and the duration of symptoms in those who are varies widely, they noted. “Interestingly, this study aligns with adult data in which up to 40% of adults may remain asymptomatic in the face of infection.”

However, “The third and most important take-home point from this study relates to the duration of viral shedding in infected pediatric patients,” Dr. DeBiasi and Dr. Delaney said (JAMA Pediatr. 2020 Aug 28. doi: 10.1001/jamapediatrics.2020.3996).

“Fully half of symptomatic children with both upper and lower tract disease were still shedding virus at 21 days. These are striking data, particularly since 86 of 88 diagnosed children (98%) either had no symptoms or mild or moderate disease,” they explained. The results highlight the need for improvements in qualitative molecular testing and formal studies to identify differences in results from different testing scenarios, such as hospital entry, preprocedure screening, and symptomatic testing. In addition, “these findings are highly relevant to the development of public health strategies to mitigate and contain spread within communities, particularly as affected communities begin their recovery phases.”

The study is important because “schools are opening, and we don’t know what is going to happen,” Michael E. Pichichero, MD, of Rochester General Hospital, N.Y., said in an interview.

“Clinicians, parents, students, school administrators and politicians are worried,” he said. “This study adds to others recently published, bringing into focus the challenges to several suppositions that existed when the COVID-19 pandemic began and over the summer.”

“This study of 91 Korean children tells us that taking a child’s temperature as a screening tool to decide if they may enter school will not be a highly successful strategy,” he said. “Many children are without fever and asymptomatic when infected and contagious. The notion that children shed less virus or shed it for shorter lengths of time we keep learning from this type of research is not true. In another recent study the authors found that children shed as much of the SARS-CoV-2 virus as an adult in the ICU on a ventilator.”

Dr. Pichichero said he was not surprised by the study findings. “A similar paper was published last week in the Journal of Pediatrics from Massachusetts General Hospital, so the findings in the JAMA paper are similar to what has been reported in the United States.”

“Availability of testing will continue to be a challenge in some communities,” said Dr. Pichichero. “Here in the Rochester, New York, area we will use a screening questionnaire based on the CDC [Centers for Disease Control and Prevention] symptom criteria of SARS-CoV-2 infections to decide whom to test.”

As for additional research, “We have so much more to learn about SARS-CoV-2 in children,” he emphasized. “The focus has been on adults because the morbidity and mortality has been greatest in adults, especially the elderly and those with compromised health.”

“The National Institutes of Health has issued a call for more research in children to characterize the spectrum of SARS-CoV-2 illness, including the multisystem inflammatory syndrome in children [MIS-C] and try to identify biomarkers and/or biosignatures for a prognostic algorithm to predict the longitudinal risk of disease severity after a child is exposed to and may be infected with SARS-CoV-2,” said Dr. Pichichero. “NIH has asked researchers to answer the following questions.”

• Why do children have milder illness?
• Are there differences in childhood biology (e.g., gender, puberty, etc.) that contribute to illness severity?
• Are there genetic host differences associated with different disease severity phenotypes, including MIS-C?
• Are there innate mucosal, humoral, cellular and other adaptive immune profiles that are associated with reduced or increased risk of progressive disease, including previous coronavirus infections?
• Will SARS-CoV-2 reinfection cause worse disease as seen with antibody-dependent enhancement (ADE) in other viral infections (e.g., dengue)? Will future vaccines carry a risk of the ADE phenomenon?
• Does substance use (e.g., nicotine, marijuana) exacerbate or trigger MIS-C through immune activation?

“We have no knowledge yet about SARS-CoV-2 vaccination of children, especially young children,” Dr. Pichichero emphasized. “There are different types of vaccines – messenger RNA, adenovirus vector and purified spike proteins of the virus – among others, but questions remain: Will the vaccines work in children? What about side effects? Will the antibodies and cellular immunity protect partially or completely?”

The researchers and editorialists had no financial conflicts to disclose. Dr. Pichichero had no financial conflicts to disclose.

SOURCE: Han MS et al. JAMA Pediatr. 2020 Aug 28. doi:10.1001/jamapediatrics.2020.3988.

Early administration of evolocumab significantly reduced levels of LDL cholesterol in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention, according to data from an open-label randomized trial of 102 adults in Japan.

Data from previous studies have shown that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors can reduce LDL cholesterol in acute coronary syndrome patients, wrote Tomoaki Okada, MD, of Kagawa (Japan) Prefectural Central Hospital and colleagues.

In particular, “The EVOPACS trial [J Am Coll Cardiol 2019; 74:2452-62] reported that evolocumab therapy initiated at an early phase of ACS showed [LDL cholesterol] level reduction by 4-8 weeks,” they said.

“However, the 4-week efficacy of PCSK9 inhibitor therapy combined with a statin remains unknown,” they said.

In a study presented at the virtual annual congress of the European Society of Cardiology and published simultaneously in JACC: Cardiovascular Interventions, the researchers randomized 52 patients to receive 140 mg of evolocumab subcutaneously within 24 hours of indexed percutaneous coronary intervention and again after 2 weeks. A group of 50 controls received evolocumab after PCI only, but no additional dose after 2 weeks.

The average age of the patients was 65 years, 88% were men, and 26% had a history of statin treatment.

A total of 49 patients in each group were included in the final analysis, with a primary outcome of change in LDL cholesterol levels from baseline to 4 weeks.

Baseline LCL cholesterol levels were 120.8 mg/dL and 124.7 mg/dL in the evolocumab and control groups, respectively. Changes from baseline were significantly greater in the evolocumab group, compared with controls, at –76% and –33%, respectively.

All patients in the evolocumab group and 27% of patients in the control groups achieved LDL cholesterol levels of less than 70 mg/dL at 4 weeks. In addition, 92% and 96% of evolocumab patients achieved LDL cholesterol levels less than 55 mg/dL at 2 weeks and 4 weeks, respectively.

Overall changes in non-HDL cholesterol, HDL cholesterol, and small dense LDL in the evolocumab and control groups were –66.2% and –26.0%; 2.8% and –0.7%; and –67% and –13.8%, respectively. Of these, changes in non-HDL cholesterol and small dense LDL were significantly different between the groups.

In addition, patients in the evolocumab group showed a 3% decrease in lipoprotein, compared with an 82% increase in the control group. This finding suggests the additional benefit of including evolocumab for managing residual risk in patients with high lipoprotein(a) levels” after acute MI, the researchers noted.

Adverse events and serious adverse events were similar between the groups.

‘Early and strong’ LDL cholesterol lowering best for preventing repeat events

“By using the PCSK9 inhibitors, we have the opportunity to lower LDL cholesterol [LDL-C]” both quickly and dramatically, said Heinz Drexel, MD, in an interview.

“This Japanese study shows that very low LDL-C levels can be obtained as fast as within 4 weeks,” he said. “This fits into the concept that risk for future infarctions and strokes is best reduced by early and strong LDL-C lowering,” he explained.

Dr. Drexel said that he was not surprised by the magnitude of the decrease in LDL cholesterol in study findings in light of the EVOPACS study and other research, as well as his own clinical experience.

“The primary message for doctors is that it is now possible to achieve these low levels of LDL-C in a short time,” he said.

“Additional research must prove that this low LDL-C translates to reduction of MIs and strokes, and there is increasing evidence that this will happen,” Dr. Drexel noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Drexel had no financial conflicts to disclose.

SOURCE: Okada T et al. ESC 2020. JACC Cardiovascular Interventions. 2020 Aug 28. doi: 10.1016/j.jcin.2020.08.026.

Early administration of evolocumab significantly reduced levels of LDL cholesterol in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention, according to data from an open-label randomized trial of 102 adults in Japan.

Data from previous studies have shown that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors can reduce LDL cholesterol in acute coronary syndrome patients, wrote Tomoaki Okada, MD, of Kagawa (Japan) Prefectural Central Hospital and colleagues.

In particular, “The EVOPACS trial [J Am Coll Cardiol 2019; 74:2452-62] reported that evolocumab therapy initiated at an early phase of ACS showed [LDL cholesterol] level reduction by 4-8 weeks,” they said.

“However, the 4-week efficacy of PCSK9 inhibitor therapy combined with a statin remains unknown,” they said.

In a study presented at the virtual annual congress of the European Society of Cardiology and published simultaneously in JACC: Cardiovascular Interventions, the researchers randomized 52 patients to receive 140 mg of evolocumab subcutaneously within 24 hours of indexed percutaneous coronary intervention and again after 2 weeks. A group of 50 controls received evolocumab after PCI only, but no additional dose after 2 weeks.

The average age of the patients was 65 years, 88% were men, and 26% had a history of statin treatment.

A total of 49 patients in each group were included in the final analysis, with a primary outcome of change in LDL cholesterol levels from baseline to 4 weeks.

Baseline LCL cholesterol levels were 120.8 mg/dL and 124.7 mg/dL in the evolocumab and control groups, respectively. Changes from baseline were significantly greater in the evolocumab group, compared with controls, at –76% and –33%, respectively.

All patients in the evolocumab group and 27% of patients in the control groups achieved LDL cholesterol levels of less than 70 mg/dL at 4 weeks. In addition, 92% and 96% of evolocumab patients achieved LDL cholesterol levels less than 55 mg/dL at 2 weeks and 4 weeks, respectively.

Overall changes in non-HDL cholesterol, HDL cholesterol, and small dense LDL in the evolocumab and control groups were –66.2% and –26.0%; 2.8% and –0.7%; and –67% and –13.8%, respectively. Of these, changes in non-HDL cholesterol and small dense LDL were significantly different between the groups.

In addition, patients in the evolocumab group showed a 3% decrease in lipoprotein, compared with an 82% increase in the control group. This finding suggests the additional benefit of including evolocumab for managing residual risk in patients with high lipoprotein(a) levels” after acute MI, the researchers noted.

Adverse events and serious adverse events were similar between the groups.

‘Early and strong’ LDL cholesterol lowering best for preventing repeat events

“By using the PCSK9 inhibitors, we have the opportunity to lower LDL cholesterol [LDL-C]” both quickly and dramatically, said Heinz Drexel, MD, in an interview.

“This Japanese study shows that very low LDL-C levels can be obtained as fast as within 4 weeks,” he said. “This fits into the concept that risk for future infarctions and strokes is best reduced by early and strong LDL-C lowering,” he explained.

Dr. Drexel said that he was not surprised by the magnitude of the decrease in LDL cholesterol in study findings in light of the EVOPACS study and other research, as well as his own clinical experience.

“The primary message for doctors is that it is now possible to achieve these low levels of LDL-C in a short time,” he said.

“Additional research must prove that this low LDL-C translates to reduction of MIs and strokes, and there is increasing evidence that this will happen,” Dr. Drexel noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Drexel had no financial conflicts to disclose.

SOURCE: Okada T et al. ESC 2020. JACC Cardiovascular Interventions. 2020 Aug 28. doi: 10.1016/j.jcin.2020.08.026.

Early administration of evolocumab significantly reduced levels of LDL cholesterol in patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention, according to data from an open-label randomized trial of 102 adults in Japan.

Data from previous studies have shown that proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors can reduce LDL cholesterol in acute coronary syndrome patients, wrote Tomoaki Okada, MD, of Kagawa (Japan) Prefectural Central Hospital and colleagues.

In particular, “The EVOPACS trial [J Am Coll Cardiol 2019; 74:2452-62] reported that evolocumab therapy initiated at an early phase of ACS showed [LDL cholesterol] level reduction by 4-8 weeks,” they said.

“However, the 4-week efficacy of PCSK9 inhibitor therapy combined with a statin remains unknown,” they said.

In a study presented at the virtual annual congress of the European Society of Cardiology and published simultaneously in JACC: Cardiovascular Interventions, the researchers randomized 52 patients to receive 140 mg of evolocumab subcutaneously within 24 hours of indexed percutaneous coronary intervention and again after 2 weeks. A group of 50 controls received evolocumab after PCI only, but no additional dose after 2 weeks.

The average age of the patients was 65 years, 88% were men, and 26% had a history of statin treatment.

A total of 49 patients in each group were included in the final analysis, with a primary outcome of change in LDL cholesterol levels from baseline to 4 weeks.

Baseline LCL cholesterol levels were 120.8 mg/dL and 124.7 mg/dL in the evolocumab and control groups, respectively. Changes from baseline were significantly greater in the evolocumab group, compared with controls, at –76% and –33%, respectively.

All patients in the evolocumab group and 27% of patients in the control groups achieved LDL cholesterol levels of less than 70 mg/dL at 4 weeks. In addition, 92% and 96% of evolocumab patients achieved LDL cholesterol levels less than 55 mg/dL at 2 weeks and 4 weeks, respectively.

Overall changes in non-HDL cholesterol, HDL cholesterol, and small dense LDL in the evolocumab and control groups were –66.2% and –26.0%; 2.8% and –0.7%; and –67% and –13.8%, respectively. Of these, changes in non-HDL cholesterol and small dense LDL were significantly different between the groups.

In addition, patients in the evolocumab group showed a 3% decrease in lipoprotein, compared with an 82% increase in the control group. This finding suggests the additional benefit of including evolocumab for managing residual risk in patients with high lipoprotein(a) levels” after acute MI, the researchers noted.

Adverse events and serious adverse events were similar between the groups.

‘Early and strong’ LDL cholesterol lowering best for preventing repeat events

“By using the PCSK9 inhibitors, we have the opportunity to lower LDL cholesterol [LDL-C]” both quickly and dramatically, said Heinz Drexel, MD, in an interview.

“This Japanese study shows that very low LDL-C levels can be obtained as fast as within 4 weeks,” he said. “This fits into the concept that risk for future infarctions and strokes is best reduced by early and strong LDL-C lowering,” he explained.

Dr. Drexel said that he was not surprised by the magnitude of the decrease in LDL cholesterol in study findings in light of the EVOPACS study and other research, as well as his own clinical experience.

“The primary message for doctors is that it is now possible to achieve these low levels of LDL-C in a short time,” he said.

“Additional research must prove that this low LDL-C translates to reduction of MIs and strokes, and there is increasing evidence that this will happen,” Dr. Drexel noted.

The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Drexel had no financial conflicts to disclose.

SOURCE: Okada T et al. ESC 2020. JACC Cardiovascular Interventions. 2020 Aug 28. doi: 10.1016/j.jcin.2020.08.026.

Patients with chronic obstructive pulmonary disease who also had certain interstitial lung abnormalities experienced more exacerbations and reduced lung function than those without such abnormalities, findings from a retrospective study has shown.

Interstitial lung abnormalities (ILA) are considered precursor lesions of interstitial lung disease and previous studies suggested an association with poor outcomes among chronic obstructive pulmonary disease (COPD) patients, but data on long-term clinical relevance are limited, wrote Tae Seung Lee, MD, of Seoul (South Korea) National University Hospital, and colleagues.

In a study published in Chest, the researchers reviewed data from 363 COPD patients including 44 with equivocal ILA and 103 with definite ILA. Overall, the ILA patients were older and had poorer lung function than non-ILA patients. Patients received chest CT scan and longitudinal pulmonary function tests between January 2013 and December 2018.

Over an average follow-up period of 5.4 years, patients with ILA experienced significantly more acute COPD exacerbations than did those without ILA (adjusted odds ratio, 2.03). The percentages of frequent exacerbators among patients with no ILA, equivocal ILA, and definite ILA were 8.3%, 15.9%, and 20.4%, respectively.

“Acute exacerbation is an important event during the clinical course of COPD, because it is associated with temporary or persistent reductions in lung function, lower quality of life, hospitalization, and mortality,” the researchers noted.

In a multivariate analysis, the annual decline in lung function (FEV₁) was –35.7 in patients with equivocal ILA, compared with –28.0 in patients with no ILA and –15.9 in those with definite ILA.

“This may be due to the distribution of the spirometric stages in each group, and to the resulting changes in lung function,” the researchers wrote. In this study, “the equivocal ILA group had a significantly lower baseline FEV₁ than the other groups. In our study population, the lower the spirometric stage, the faster the annual decline in FEV₁, consistent with the results of a prior prospective study of a COPD cohort.”

The findings were limited by several factors including the retrospective design and relatively small number of ILA patients, as well as the limited evaluation of ILA and potential for selection bias, the researchers noted. However, the result support the impact of ILA on exacerbations and accelerated decline in lung function in COPD patients.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Lee TS et al. Chest. 2020 Aug 13. doi: 10.1016/j.chest.2020.08.017.

Patients with chronic obstructive pulmonary disease who also had certain interstitial lung abnormalities experienced more exacerbations and reduced lung function than those without such abnormalities, findings from a retrospective study has shown.

Interstitial lung abnormalities (ILA) are considered precursor lesions of interstitial lung disease and previous studies suggested an association with poor outcomes among chronic obstructive pulmonary disease (COPD) patients, but data on long-term clinical relevance are limited, wrote Tae Seung Lee, MD, of Seoul (South Korea) National University Hospital, and colleagues.

In a study published in Chest, the researchers reviewed data from 363 COPD patients including 44 with equivocal ILA and 103 with definite ILA. Overall, the ILA patients were older and had poorer lung function than non-ILA patients. Patients received chest CT scan and longitudinal pulmonary function tests between January 2013 and December 2018.

Over an average follow-up period of 5.4 years, patients with ILA experienced significantly more acute COPD exacerbations than did those without ILA (adjusted odds ratio, 2.03). The percentages of frequent exacerbators among patients with no ILA, equivocal ILA, and definite ILA were 8.3%, 15.9%, and 20.4%, respectively.

“Acute exacerbation is an important event during the clinical course of COPD, because it is associated with temporary or persistent reductions in lung function, lower quality of life, hospitalization, and mortality,” the researchers noted.

In a multivariate analysis, the annual decline in lung function (FEV₁) was –35.7 in patients with equivocal ILA, compared with –28.0 in patients with no ILA and –15.9 in those with definite ILA.

“This may be due to the distribution of the spirometric stages in each group, and to the resulting changes in lung function,” the researchers wrote. In this study, “the equivocal ILA group had a significantly lower baseline FEV₁ than the other groups. In our study population, the lower the spirometric stage, the faster the annual decline in FEV₁, consistent with the results of a prior prospective study of a COPD cohort.”

The findings were limited by several factors including the retrospective design and relatively small number of ILA patients, as well as the limited evaluation of ILA and potential for selection bias, the researchers noted. However, the result support the impact of ILA on exacerbations and accelerated decline in lung function in COPD patients.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Lee TS et al. Chest. 2020 Aug 13. doi: 10.1016/j.chest.2020.08.017.

Patients with chronic obstructive pulmonary disease who also had certain interstitial lung abnormalities experienced more exacerbations and reduced lung function than those without such abnormalities, findings from a retrospective study has shown.

Interstitial lung abnormalities (ILA) are considered precursor lesions of interstitial lung disease and previous studies suggested an association with poor outcomes among chronic obstructive pulmonary disease (COPD) patients, but data on long-term clinical relevance are limited, wrote Tae Seung Lee, MD, of Seoul (South Korea) National University Hospital, and colleagues.

In a study published in Chest, the researchers reviewed data from 363 COPD patients including 44 with equivocal ILA and 103 with definite ILA. Overall, the ILA patients were older and had poorer lung function than non-ILA patients. Patients received chest CT scan and longitudinal pulmonary function tests between January 2013 and December 2018.

Over an average follow-up period of 5.4 years, patients with ILA experienced significantly more acute COPD exacerbations than did those without ILA (adjusted odds ratio, 2.03). The percentages of frequent exacerbators among patients with no ILA, equivocal ILA, and definite ILA were 8.3%, 15.9%, and 20.4%, respectively.

“Acute exacerbation is an important event during the clinical course of COPD, because it is associated with temporary or persistent reductions in lung function, lower quality of life, hospitalization, and mortality,” the researchers noted.

In a multivariate analysis, the annual decline in lung function (FEV₁) was –35.7 in patients with equivocal ILA, compared with –28.0 in patients with no ILA and –15.9 in those with definite ILA.

“This may be due to the distribution of the spirometric stages in each group, and to the resulting changes in lung function,” the researchers wrote. In this study, “the equivocal ILA group had a significantly lower baseline FEV₁ than the other groups. In our study population, the lower the spirometric stage, the faster the annual decline in FEV₁, consistent with the results of a prior prospective study of a COPD cohort.”

The findings were limited by several factors including the retrospective design and relatively small number of ILA patients, as well as the limited evaluation of ILA and potential for selection bias, the researchers noted. However, the result support the impact of ILA on exacerbations and accelerated decline in lung function in COPD patients.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Lee TS et al. Chest. 2020 Aug 13. doi: 10.1016/j.chest.2020.08.017.

Microorganisms in the human digestive tract are linked to 29 specific health conditions, including chronic obstructive pulmonary disease, high blood pressure, and type 2 diabetes, according to a genome analysis in more than 400,000 individuals.

European Society of Cardiology

Although previous studies have suggested a link between gut microbiota and diseases in humans, “the extent to which the human gut microbiome can be considered a determinant of disease and healthy aging remains unknown,” Hilde E. Groot, MD, of the University of Groningen (The Netherlands), said in a presentation at the virtual annual congress of the European Society of Cardiology.

To identify the spectrum of diseases linked to the gut microbiome, the researchers identified 422,417 unrelated adults of White British ancestry with genotype and matching genetic data. The average age of the participants was 57 years and 46% were male.

The researchers conducted a phenomewide association study including 35 distinct single-nucleotide polymorphisms (SNPs) that are known to influence the microbiome of the human gut.

Overall, seven SNPs were significantly associated with 29 disease outcomes including hypertension, type 2 diabetes, hypercholesterolemia, heart failure, renal failure, and osteoarthritis.

In addition, after a further sensitivity analysis using a Mendelian randomization (MR) approach, associations between Ruminococcus flavefaciens and hypertension and between Clostridium and platelet count might point to a causal link, the researchers said.

“Over the past few years, the amount of research concerning the human gut microbiome and the associations with health and disease has tremendously increased. However, most studies investigated one or a few traits. The strength of our study is the possibility to cover a wide range of traits simultaneously within one population,” Dr. Groot said in an interview.

“Our data support the hypothesis that the human gut microbiome is a complex system, involved in many pathophysiological mechanisms in the human body. So, our results are additional to earlier research and strengthen this hypothesis,” Dr. Groot added.

“Microbiota and their metabolites might be of importance in the interplay between overlapping pathophysiological processes, and could serve as potential therapeutic targets for the maintenance of health and prevention and treatment of cardiovascular diseases. However, before it is possible to give advice for the public and medical practice, further research is needed to study causality,” she emphasized.

“Currently, it is too soon to advise patients concerning their microbiome,” Dr. Groot noted. “However, genetic studies like ours might help other researchers to study causality between the gut microbiome and particular traits, which might potentially lead to new therapeutic targets. Next to genetic variants as a proxy, we’re currently studying the gut microbiome composition in myocardial infarction patients and healthy controls in a longitudinal setting.”

“Previous studies have suggested a potential link between the gut microbiome and the development of cardiovascular disease, type 2 diabetes mellitus, and other chronic disorders,” Carol Ann Remme, MD, of the Amsterdam University Medical Center, said in an interview. “However, it is challenging to study the effect of gut microbiome composition in large patient cohorts. As an alternative approach, the study authors showed in a very large population that genetic variants previously shown to influence gut microbiome composition were significantly associated with conditions such as hypertension, type 2 diabetes, hypercholesterolemia, and heart failure.”

The study is unique in that it employed a very large cohort of more than 400,000 individuals, which is typically required to be able to draw clear conclusions, Dr. Remme continued. “The authors were able to further refine their findings by linking genetic variants known to influence specific gut bacteria to some particular disorders,” she noted.

“It is becoming increasingly clear that an individual’s gut microbiome composition, which is defined by both genetic and environmental factors such as diet, may affect his/her susceptibility to certain diseases – including cardiovascular – in addition to disease progression and outcome,” said Dr. Remme. “This may ultimately lead to development of novel, personalized strategies for risk stratification in addition to potential preventive measures targeting the gut microbiome. I expect this area of research will become increasingly important in the coming years.”

The study received no outside funding. Dr. Groot and colleagues had no financial conflicts to disclose. Dr. Remme had no financial conflicts to disclose.

Microorganisms in the human digestive tract are linked to 29 specific health conditions, including chronic obstructive pulmonary disease, high blood pressure, and type 2 diabetes, according to a genome analysis in more than 400,000 individuals.

European Society of Cardiology

Although previous studies have suggested a link between gut microbiota and diseases in humans, “the extent to which the human gut microbiome can be considered a determinant of disease and healthy aging remains unknown,” Hilde E. Groot, MD, of the University of Groningen (The Netherlands), said in a presentation at the virtual annual congress of the European Society of Cardiology.

To identify the spectrum of diseases linked to the gut microbiome, the researchers identified 422,417 unrelated adults of White British ancestry with genotype and matching genetic data. The average age of the participants was 57 years and 46% were male.

The researchers conducted a phenomewide association study including 35 distinct single-nucleotide polymorphisms (SNPs) that are known to influence the microbiome of the human gut.

Overall, seven SNPs were significantly associated with 29 disease outcomes including hypertension, type 2 diabetes, hypercholesterolemia, heart failure, renal failure, and osteoarthritis.

In addition, after a further sensitivity analysis using a Mendelian randomization (MR) approach, associations between Ruminococcus flavefaciens and hypertension and between Clostridium and platelet count might point to a causal link, the researchers said.

“Over the past few years, the amount of research concerning the human gut microbiome and the associations with health and disease has tremendously increased. However, most studies investigated one or a few traits. The strength of our study is the possibility to cover a wide range of traits simultaneously within one population,” Dr. Groot said in an interview.

“Our data support the hypothesis that the human gut microbiome is a complex system, involved in many pathophysiological mechanisms in the human body. So, our results are additional to earlier research and strengthen this hypothesis,” Dr. Groot added.

“Microbiota and their metabolites might be of importance in the interplay between overlapping pathophysiological processes, and could serve as potential therapeutic targets for the maintenance of health and prevention and treatment of cardiovascular diseases. However, before it is possible to give advice for the public and medical practice, further research is needed to study causality,” she emphasized.

“Currently, it is too soon to advise patients concerning their microbiome,” Dr. Groot noted. “However, genetic studies like ours might help other researchers to study causality between the gut microbiome and particular traits, which might potentially lead to new therapeutic targets. Next to genetic variants as a proxy, we’re currently studying the gut microbiome composition in myocardial infarction patients and healthy controls in a longitudinal setting.”

“Previous studies have suggested a potential link between the gut microbiome and the development of cardiovascular disease, type 2 diabetes mellitus, and other chronic disorders,” Carol Ann Remme, MD, of the Amsterdam University Medical Center, said in an interview. “However, it is challenging to study the effect of gut microbiome composition in large patient cohorts. As an alternative approach, the study authors showed in a very large population that genetic variants previously shown to influence gut microbiome composition were significantly associated with conditions such as hypertension, type 2 diabetes, hypercholesterolemia, and heart failure.”

The study is unique in that it employed a very large cohort of more than 400,000 individuals, which is typically required to be able to draw clear conclusions, Dr. Remme continued. “The authors were able to further refine their findings by linking genetic variants known to influence specific gut bacteria to some particular disorders,” she noted.

“It is becoming increasingly clear that an individual’s gut microbiome composition, which is defined by both genetic and environmental factors such as diet, may affect his/her susceptibility to certain diseases – including cardiovascular – in addition to disease progression and outcome,” said Dr. Remme. “This may ultimately lead to development of novel, personalized strategies for risk stratification in addition to potential preventive measures targeting the gut microbiome. I expect this area of research will become increasingly important in the coming years.”

The study received no outside funding. Dr. Groot and colleagues had no financial conflicts to disclose. Dr. Remme had no financial conflicts to disclose.

Microorganisms in the human digestive tract are linked to 29 specific health conditions, including chronic obstructive pulmonary disease, high blood pressure, and type 2 diabetes, according to a genome analysis in more than 400,000 individuals.

European Society of Cardiology

Although previous studies have suggested a link between gut microbiota and diseases in humans, “the extent to which the human gut microbiome can be considered a determinant of disease and healthy aging remains unknown,” Hilde E. Groot, MD, of the University of Groningen (The Netherlands), said in a presentation at the virtual annual congress of the European Society of Cardiology.

To identify the spectrum of diseases linked to the gut microbiome, the researchers identified 422,417 unrelated adults of White British ancestry with genotype and matching genetic data. The average age of the participants was 57 years and 46% were male.

The researchers conducted a phenomewide association study including 35 distinct single-nucleotide polymorphisms (SNPs) that are known to influence the microbiome of the human gut.

Overall, seven SNPs were significantly associated with 29 disease outcomes including hypertension, type 2 diabetes, hypercholesterolemia, heart failure, renal failure, and osteoarthritis.

In addition, after a further sensitivity analysis using a Mendelian randomization (MR) approach, associations between Ruminococcus flavefaciens and hypertension and between Clostridium and platelet count might point to a causal link, the researchers said.

“Over the past few years, the amount of research concerning the human gut microbiome and the associations with health and disease has tremendously increased. However, most studies investigated one or a few traits. The strength of our study is the possibility to cover a wide range of traits simultaneously within one population,” Dr. Groot said in an interview.

“Our data support the hypothesis that the human gut microbiome is a complex system, involved in many pathophysiological mechanisms in the human body. So, our results are additional to earlier research and strengthen this hypothesis,” Dr. Groot added.

“Microbiota and their metabolites might be of importance in the interplay between overlapping pathophysiological processes, and could serve as potential therapeutic targets for the maintenance of health and prevention and treatment of cardiovascular diseases. However, before it is possible to give advice for the public and medical practice, further research is needed to study causality,” she emphasized.

“Currently, it is too soon to advise patients concerning their microbiome,” Dr. Groot noted. “However, genetic studies like ours might help other researchers to study causality between the gut microbiome and particular traits, which might potentially lead to new therapeutic targets. Next to genetic variants as a proxy, we’re currently studying the gut microbiome composition in myocardial infarction patients and healthy controls in a longitudinal setting.”

“Previous studies have suggested a potential link between the gut microbiome and the development of cardiovascular disease, type 2 diabetes mellitus, and other chronic disorders,” Carol Ann Remme, MD, of the Amsterdam University Medical Center, said in an interview. “However, it is challenging to study the effect of gut microbiome composition in large patient cohorts. As an alternative approach, the study authors showed in a very large population that genetic variants previously shown to influence gut microbiome composition were significantly associated with conditions such as hypertension, type 2 diabetes, hypercholesterolemia, and heart failure.”

The study is unique in that it employed a very large cohort of more than 400,000 individuals, which is typically required to be able to draw clear conclusions, Dr. Remme continued. “The authors were able to further refine their findings by linking genetic variants known to influence specific gut bacteria to some particular disorders,” she noted.

“It is becoming increasingly clear that an individual’s gut microbiome composition, which is defined by both genetic and environmental factors such as diet, may affect his/her susceptibility to certain diseases – including cardiovascular – in addition to disease progression and outcome,” said Dr. Remme. “This may ultimately lead to development of novel, personalized strategies for risk stratification in addition to potential preventive measures targeting the gut microbiome. I expect this area of research will become increasingly important in the coming years.”

The study received no outside funding. Dr. Groot and colleagues had no financial conflicts to disclose. Dr. Remme had no financial conflicts to disclose.

Breast milk is an unlikely source of transmission of SARS-CoV-2 from mothers to infants, according to data from case reports and breast milk samples from 18 women.

South_agency/Getty Images

“To date, SARS-CoV-2 has not been isolated from breast milk, and there are no documented cases of transmission of infectious virus to the infant through breast milk,” but the potential for transmission remains a concern among women who want to breastfeed, wrote Christina Chambers, PhD, of the University of California, San Diego, and colleagues.

In a research letter published in JAMA, the investigators identified 18 women with confirmed SARS-CoV-2 infections (all but 1 of the women had symptomatic COVID-19 disease) and infants aged 0-19 months between March 27 and May 6, 2020. The average age of the mothers was 34 years, and 78% were non-Hispanic White. The women provided 1-12 samples of breast milk for a total of 64 samples collected before and after positive COVID-19 tests.

One sample yielded detectable RNA from SARS-CoV-2 and was collected on the day of the woman’s symptom onset. However, one sample taken 2 days prior to symptom onset and two samples collected 12 and 41 days later tested negative for viral RNA, the researchers said. In addition, no replication-competent virus was identified in the positive sample or any of the other samples.

The researchers spiked two stored milk samples collected prior to the pandemic with replication-competent SARS-CoV-2. Virus was not detected by culture in the samples after Holder pasteurization, but was detected by culture in nonpasteurized aliquots of the same samples.

“These data suggest that SARS-CoV-2 RNA does not represent replication-competent virus and that breast milk may not be a source of infection for the infant,” Dr. Chambers and associates said.

The results were limited by several factors including the small sample size and potential for selection bias, as well as the use of self-reports of positive tests and self-collection of breast milk, the researchers noted. However, the findings are reassuring in light of the known benefits of breastfeeding and the use of milk banks.

“This research is important because the pandemic is ongoing and has far-reaching consequences: as the authors indicate, the potential for viral transmission through breast milk remains a critical question for women infected with SARS-CoV-2 who wish to breastfeed,” Janet R. Hardy, PhD, MPH, MSc, a consultant on global maternal-child health and pharmacoepidemiology, said in an interview.

“This virus has everyone on a rapid learning track, and all information that helps build evidence to support women’s decision-making in the care of their children is valuable,” she said. “These findings suggest that breast milk may not be a source of SARS-CoV-2 infection for the infant. They provide some reassurance given the recognized benefits of breastfeeding and human milk.”

However, “This study is very specific to breast milk,” she emphasized. “In advising women infected with SARS-CoV-2, clinicians may want to include a discussion of protection methods to prevent maternal transmission of the virus through respiratory droplets.”

Although the data are preliminary, “the investigators established and validated an RT-PCR [reverse transcription polymerase chain reaction] assay and developed tissue culture methods for replication-competent SARS-CoV-2 in breast milk, both valuable tools for further studies. Next steps will include controlled studies of greater sample size with independent verification of RT-PCR positivity,” said Dr. Hardy, a consultant to Biohaven Pharmaceuticals, New Haven, Conn.

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. Medela Corporation provided milk sample collection materials. The Family Larsson-Rosenquist Foundation provided an unrestricted COVID19 emergency gift fund. The Mothers’ Milk Bank at Austin paid for shipping costs.

SOURCE: Chambers C et al. JAMA. 2020 Aug 19. doi: 10.1001/jama.2020.15580.

Breast milk is an unlikely source of transmission of SARS-CoV-2 from mothers to infants, according to data from case reports and breast milk samples from 18 women.

South_agency/Getty Images

“To date, SARS-CoV-2 has not been isolated from breast milk, and there are no documented cases of transmission of infectious virus to the infant through breast milk,” but the potential for transmission remains a concern among women who want to breastfeed, wrote Christina Chambers, PhD, of the University of California, San Diego, and colleagues.

In a research letter published in JAMA, the investigators identified 18 women with confirmed SARS-CoV-2 infections (all but 1 of the women had symptomatic COVID-19 disease) and infants aged 0-19 months between March 27 and May 6, 2020. The average age of the mothers was 34 years, and 78% were non-Hispanic White. The women provided 1-12 samples of breast milk for a total of 64 samples collected before and after positive COVID-19 tests.

One sample yielded detectable RNA from SARS-CoV-2 and was collected on the day of the woman’s symptom onset. However, one sample taken 2 days prior to symptom onset and two samples collected 12 and 41 days later tested negative for viral RNA, the researchers said. In addition, no replication-competent virus was identified in the positive sample or any of the other samples.

The researchers spiked two stored milk samples collected prior to the pandemic with replication-competent SARS-CoV-2. Virus was not detected by culture in the samples after Holder pasteurization, but was detected by culture in nonpasteurized aliquots of the same samples.

“These data suggest that SARS-CoV-2 RNA does not represent replication-competent virus and that breast milk may not be a source of infection for the infant,” Dr. Chambers and associates said.

The results were limited by several factors including the small sample size and potential for selection bias, as well as the use of self-reports of positive tests and self-collection of breast milk, the researchers noted. However, the findings are reassuring in light of the known benefits of breastfeeding and the use of milk banks.

“This research is important because the pandemic is ongoing and has far-reaching consequences: as the authors indicate, the potential for viral transmission through breast milk remains a critical question for women infected with SARS-CoV-2 who wish to breastfeed,” Janet R. Hardy, PhD, MPH, MSc, a consultant on global maternal-child health and pharmacoepidemiology, said in an interview.

“This virus has everyone on a rapid learning track, and all information that helps build evidence to support women’s decision-making in the care of their children is valuable,” she said. “These findings suggest that breast milk may not be a source of SARS-CoV-2 infection for the infant. They provide some reassurance given the recognized benefits of breastfeeding and human milk.”

However, “This study is very specific to breast milk,” she emphasized. “In advising women infected with SARS-CoV-2, clinicians may want to include a discussion of protection methods to prevent maternal transmission of the virus through respiratory droplets.”

Although the data are preliminary, “the investigators established and validated an RT-PCR [reverse transcription polymerase chain reaction] assay and developed tissue culture methods for replication-competent SARS-CoV-2 in breast milk, both valuable tools for further studies. Next steps will include controlled studies of greater sample size with independent verification of RT-PCR positivity,” said Dr. Hardy, a consultant to Biohaven Pharmaceuticals, New Haven, Conn.

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. Medela Corporation provided milk sample collection materials. The Family Larsson-Rosenquist Foundation provided an unrestricted COVID19 emergency gift fund. The Mothers’ Milk Bank at Austin paid for shipping costs.

SOURCE: Chambers C et al. JAMA. 2020 Aug 19. doi: 10.1001/jama.2020.15580.

Breast milk is an unlikely source of transmission of SARS-CoV-2 from mothers to infants, according to data from case reports and breast milk samples from 18 women.

South_agency/Getty Images

“To date, SARS-CoV-2 has not been isolated from breast milk, and there are no documented cases of transmission of infectious virus to the infant through breast milk,” but the potential for transmission remains a concern among women who want to breastfeed, wrote Christina Chambers, PhD, of the University of California, San Diego, and colleagues.

In a research letter published in JAMA, the investigators identified 18 women with confirmed SARS-CoV-2 infections (all but 1 of the women had symptomatic COVID-19 disease) and infants aged 0-19 months between March 27 and May 6, 2020. The average age of the mothers was 34 years, and 78% were non-Hispanic White. The women provided 1-12 samples of breast milk for a total of 64 samples collected before and after positive COVID-19 tests.

One sample yielded detectable RNA from SARS-CoV-2 and was collected on the day of the woman’s symptom onset. However, one sample taken 2 days prior to symptom onset and two samples collected 12 and 41 days later tested negative for viral RNA, the researchers said. In addition, no replication-competent virus was identified in the positive sample or any of the other samples.

The researchers spiked two stored milk samples collected prior to the pandemic with replication-competent SARS-CoV-2. Virus was not detected by culture in the samples after Holder pasteurization, but was detected by culture in nonpasteurized aliquots of the same samples.

“These data suggest that SARS-CoV-2 RNA does not represent replication-competent virus and that breast milk may not be a source of infection for the infant,” Dr. Chambers and associates said.

The results were limited by several factors including the small sample size and potential for selection bias, as well as the use of self-reports of positive tests and self-collection of breast milk, the researchers noted. However, the findings are reassuring in light of the known benefits of breastfeeding and the use of milk banks.

“This research is important because the pandemic is ongoing and has far-reaching consequences: as the authors indicate, the potential for viral transmission through breast milk remains a critical question for women infected with SARS-CoV-2 who wish to breastfeed,” Janet R. Hardy, PhD, MPH, MSc, a consultant on global maternal-child health and pharmacoepidemiology, said in an interview.

“This virus has everyone on a rapid learning track, and all information that helps build evidence to support women’s decision-making in the care of their children is valuable,” she said. “These findings suggest that breast milk may not be a source of SARS-CoV-2 infection for the infant. They provide some reassurance given the recognized benefits of breastfeeding and human milk.”

However, “This study is very specific to breast milk,” she emphasized. “In advising women infected with SARS-CoV-2, clinicians may want to include a discussion of protection methods to prevent maternal transmission of the virus through respiratory droplets.”

Although the data are preliminary, “the investigators established and validated an RT-PCR [reverse transcription polymerase chain reaction] assay and developed tissue culture methods for replication-competent SARS-CoV-2 in breast milk, both valuable tools for further studies. Next steps will include controlled studies of greater sample size with independent verification of RT-PCR positivity,” said Dr. Hardy, a consultant to Biohaven Pharmaceuticals, New Haven, Conn.

The study was supported by the National Institute of Allergy and Infectious Diseases, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the National Institute of Mental Health. Medela Corporation provided milk sample collection materials. The Family Larsson-Rosenquist Foundation provided an unrestricted COVID19 emergency gift fund. The Mothers’ Milk Bank at Austin paid for shipping costs.

SOURCE: Chambers C et al. JAMA. 2020 Aug 19. doi: 10.1001/jama.2020.15580.

Anorexia nervosa may stunt the growth and impact the future height of teenage girls, according to data from 255 adolescents.

Illness and malnutrition during critical child and adolescent growth periods may limit adult height, but the effect of anorexia nervosa (AN) on growth impairment and adult height has not been well studied, wrote Dalit Modan-Moses, MD, of Chaim Sheba Medical Center, Tel Aviv, and colleagues.

Individuals with AN lose an unhealthy amount of weight on purpose through dieting, sometimes along with excessive exercise, binge eating, and/or purging, and because the condition occurs mainly in adolescents, the subsequent malnutrition may impact growth and adult height, they said.

In a study published in the Journal of Clinical Endocrinology & Metabolism, the researchers reviewed data from 255 adolescent girls who were hospitalized for AN at an average age of 15 years. They measured the girls’ height at the time of hospital admission, discharge, and at adulthood. The participants were followed in an outpatient clinic after hospital discharge with biweekly visits for the first 2 months, monthly visits for the next 4 months, and every 3 months until they reached 18 years of age. The average body mass index of the patients at the time of admission was 16 kg/m² and the average duration of illness was 2 years. Of the 225 patients, 174 had a diagnosis of restrictive type anorexia nervosa and 81 had binge-purge type.

The midparental target height was based on an average of the parents’ heights and subtracting 6.5 cm. The main outcome of adult height was significantly shorter than expected (P = .006) based on midparental target height. Although the patients’ heights increased significantly during hospitalization, from 158 cm to 159 cm (P < .001), “the change in height-SDS [standard deviation scores] was not significant and height-SDS at discharge remained significantly lower compared to the expected in a normal population,” the researchers noted.

Although premorbid height SDS in the study population were similar to normal adolescents, the height-SDS measurements at hospital admission, discharge, and adulthood were significantly lower than expected (–0.36, –0.34, and –0.29, respectively).

Independent predictors of height improvement from hospital admission to adulthood were patient age and bone age at the time of hospital admission, linear growth during hospitalization, and change in luteinizing hormone (LH) during hospitalization, based on a stepwise forward linear regression analysis.

The findings were limited by several factors including the inpatient study population, which may limit the generalizability to patients with less severe illness, as well as incomplete data on LH levels, which were undetectable in 19% of the patients, the researchers noted. However, the study is among the largest to describe growth in female AN patients and included data on linear growth and LH not described in other studies, they said.

“Our study is unique in presenting complete growth data (premorbid, admission, discharge, AH) as well as target height, laboratory results and bone age data in a large cohort of adolescent females with AN,” they wrote.

The findings not only support the need for early intervention in patients with AN and the need for long-term weight gain to achieve catch-up growth, but also may apply to management of malnutrition in adolescents with chronic diseases such as cystic fibrosis and inflammatory bowel disease, they concluded.

“Anorexia nervosa is a prevalent and severe disease with multiple short- and long-term complications. Still, despite the large body of research regarding this disease, data regarding growth patterns and final height of patients was incomplete and inconclusive, Dr. Modan-Moses said in an interview. The findings were not surprising, and were consistent with the results of a previous study the researchers conducted (Modan-Moses D et al. PLoS One. 2012 Sept 18. doi: 10.1371/journal.pone.0045504).

“Our first study was retrospective, and many pertinent parameters influencing growth were not available,” Dr. Modan-Moses noted. “The current study was designed to include a comprehensive evaluation including examination of the patients to document how far advanced in puberty they were, measuring height of parents in order to document the genetic height potential, bone age x-rays of the hand to determine the growth potential at the time of admission to hospitalization, and laboratory tests. This design enabled us to validate the results of our first study so that our findings are now more scientifically grounded,” she said.  

“Our findings imply that in many cases there is a considerable delay in the diagnosis of anorexia nervosa, so that by the time of diagnosis significant growth delay has already occurred. Our findings also imply that damage caused by this delay in diagnosis was in part irreversible, even with intensive treatment,” Dr. Modan-Moses emphasized. On a clinical level, the results highlight the “importance of careful monitoring of height and weight by pediatricians, and early detection and early initiation of treatment of anorexia nervosa in adolescents with long-term efforts to improve and accelerate weight gain in order to prevent complications,” she said. “Research is needed to better define factors affecting catch-up growth (that is improved growth with correction of the height deficit observed at the time of admission) and to determine accordingly optimal treatment plans,” Dr. Modan-Moses added.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Modan-Moses D et al. J Clin Endocrinol Metab. 2020 Aug 20. doi: 10.1210/clinem/dgaa510.

Anorexia nervosa may stunt the growth and impact the future height of teenage girls, according to data from 255 adolescents.

Illness and malnutrition during critical child and adolescent growth periods may limit adult height, but the effect of anorexia nervosa (AN) on growth impairment and adult height has not been well studied, wrote Dalit Modan-Moses, MD, of Chaim Sheba Medical Center, Tel Aviv, and colleagues.

Individuals with AN lose an unhealthy amount of weight on purpose through dieting, sometimes along with excessive exercise, binge eating, and/or purging, and because the condition occurs mainly in adolescents, the subsequent malnutrition may impact growth and adult height, they said.

In a study published in the Journal of Clinical Endocrinology & Metabolism, the researchers reviewed data from 255 adolescent girls who were hospitalized for AN at an average age of 15 years. They measured the girls’ height at the time of hospital admission, discharge, and at adulthood. The participants were followed in an outpatient clinic after hospital discharge with biweekly visits for the first 2 months, monthly visits for the next 4 months, and every 3 months until they reached 18 years of age. The average body mass index of the patients at the time of admission was 16 kg/m² and the average duration of illness was 2 years. Of the 225 patients, 174 had a diagnosis of restrictive type anorexia nervosa and 81 had binge-purge type.

The midparental target height was based on an average of the parents’ heights and subtracting 6.5 cm. The main outcome of adult height was significantly shorter than expected (P = .006) based on midparental target height. Although the patients’ heights increased significantly during hospitalization, from 158 cm to 159 cm (P < .001), “the change in height-SDS [standard deviation scores] was not significant and height-SDS at discharge remained significantly lower compared to the expected in a normal population,” the researchers noted.

Although premorbid height SDS in the study population were similar to normal adolescents, the height-SDS measurements at hospital admission, discharge, and adulthood were significantly lower than expected (–0.36, –0.34, and –0.29, respectively).

Independent predictors of height improvement from hospital admission to adulthood were patient age and bone age at the time of hospital admission, linear growth during hospitalization, and change in luteinizing hormone (LH) during hospitalization, based on a stepwise forward linear regression analysis.

The findings were limited by several factors including the inpatient study population, which may limit the generalizability to patients with less severe illness, as well as incomplete data on LH levels, which were undetectable in 19% of the patients, the researchers noted. However, the study is among the largest to describe growth in female AN patients and included data on linear growth and LH not described in other studies, they said.

“Our study is unique in presenting complete growth data (premorbid, admission, discharge, AH) as well as target height, laboratory results and bone age data in a large cohort of adolescent females with AN,” they wrote.

The findings not only support the need for early intervention in patients with AN and the need for long-term weight gain to achieve catch-up growth, but also may apply to management of malnutrition in adolescents with chronic diseases such as cystic fibrosis and inflammatory bowel disease, they concluded.

“Anorexia nervosa is a prevalent and severe disease with multiple short- and long-term complications. Still, despite the large body of research regarding this disease, data regarding growth patterns and final height of patients was incomplete and inconclusive, Dr. Modan-Moses said in an interview. The findings were not surprising, and were consistent with the results of a previous study the researchers conducted (Modan-Moses D et al. PLoS One. 2012 Sept 18. doi: 10.1371/journal.pone.0045504).

“Our first study was retrospective, and many pertinent parameters influencing growth were not available,” Dr. Modan-Moses noted. “The current study was designed to include a comprehensive evaluation including examination of the patients to document how far advanced in puberty they were, measuring height of parents in order to document the genetic height potential, bone age x-rays of the hand to determine the growth potential at the time of admission to hospitalization, and laboratory tests. This design enabled us to validate the results of our first study so that our findings are now more scientifically grounded,” she said.  

“Our findings imply that in many cases there is a considerable delay in the diagnosis of anorexia nervosa, so that by the time of diagnosis significant growth delay has already occurred. Our findings also imply that damage caused by this delay in diagnosis was in part irreversible, even with intensive treatment,” Dr. Modan-Moses emphasized. On a clinical level, the results highlight the “importance of careful monitoring of height and weight by pediatricians, and early detection and early initiation of treatment of anorexia nervosa in adolescents with long-term efforts to improve and accelerate weight gain in order to prevent complications,” she said. “Research is needed to better define factors affecting catch-up growth (that is improved growth with correction of the height deficit observed at the time of admission) and to determine accordingly optimal treatment plans,” Dr. Modan-Moses added.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Modan-Moses D et al. J Clin Endocrinol Metab. 2020 Aug 20. doi: 10.1210/clinem/dgaa510.

Anorexia nervosa may stunt the growth and impact the future height of teenage girls, according to data from 255 adolescents.

Illness and malnutrition during critical child and adolescent growth periods may limit adult height, but the effect of anorexia nervosa (AN) on growth impairment and adult height has not been well studied, wrote Dalit Modan-Moses, MD, of Chaim Sheba Medical Center, Tel Aviv, and colleagues.

Individuals with AN lose an unhealthy amount of weight on purpose through dieting, sometimes along with excessive exercise, binge eating, and/or purging, and because the condition occurs mainly in adolescents, the subsequent malnutrition may impact growth and adult height, they said.

In a study published in the Journal of Clinical Endocrinology & Metabolism, the researchers reviewed data from 255 adolescent girls who were hospitalized for AN at an average age of 15 years. They measured the girls’ height at the time of hospital admission, discharge, and at adulthood. The participants were followed in an outpatient clinic after hospital discharge with biweekly visits for the first 2 months, monthly visits for the next 4 months, and every 3 months until they reached 18 years of age. The average body mass index of the patients at the time of admission was 16 kg/m² and the average duration of illness was 2 years. Of the 225 patients, 174 had a diagnosis of restrictive type anorexia nervosa and 81 had binge-purge type.

The midparental target height was based on an average of the parents’ heights and subtracting 6.5 cm. The main outcome of adult height was significantly shorter than expected (P = .006) based on midparental target height. Although the patients’ heights increased significantly during hospitalization, from 158 cm to 159 cm (P < .001), “the change in height-SDS [standard deviation scores] was not significant and height-SDS at discharge remained significantly lower compared to the expected in a normal population,” the researchers noted.

Although premorbid height SDS in the study population were similar to normal adolescents, the height-SDS measurements at hospital admission, discharge, and adulthood were significantly lower than expected (–0.36, –0.34, and –0.29, respectively).

Independent predictors of height improvement from hospital admission to adulthood were patient age and bone age at the time of hospital admission, linear growth during hospitalization, and change in luteinizing hormone (LH) during hospitalization, based on a stepwise forward linear regression analysis.

The findings were limited by several factors including the inpatient study population, which may limit the generalizability to patients with less severe illness, as well as incomplete data on LH levels, which were undetectable in 19% of the patients, the researchers noted. However, the study is among the largest to describe growth in female AN patients and included data on linear growth and LH not described in other studies, they said.

“Our study is unique in presenting complete growth data (premorbid, admission, discharge, AH) as well as target height, laboratory results and bone age data in a large cohort of adolescent females with AN,” they wrote.

The findings not only support the need for early intervention in patients with AN and the need for long-term weight gain to achieve catch-up growth, but also may apply to management of malnutrition in adolescents with chronic diseases such as cystic fibrosis and inflammatory bowel disease, they concluded.

“Anorexia nervosa is a prevalent and severe disease with multiple short- and long-term complications. Still, despite the large body of research regarding this disease, data regarding growth patterns and final height of patients was incomplete and inconclusive, Dr. Modan-Moses said in an interview. The findings were not surprising, and were consistent with the results of a previous study the researchers conducted (Modan-Moses D et al. PLoS One. 2012 Sept 18. doi: 10.1371/journal.pone.0045504).

“Our first study was retrospective, and many pertinent parameters influencing growth were not available,” Dr. Modan-Moses noted. “The current study was designed to include a comprehensive evaluation including examination of the patients to document how far advanced in puberty they were, measuring height of parents in order to document the genetic height potential, bone age x-rays of the hand to determine the growth potential at the time of admission to hospitalization, and laboratory tests. This design enabled us to validate the results of our first study so that our findings are now more scientifically grounded,” she said.  

“Our findings imply that in many cases there is a considerable delay in the diagnosis of anorexia nervosa, so that by the time of diagnosis significant growth delay has already occurred. Our findings also imply that damage caused by this delay in diagnosis was in part irreversible, even with intensive treatment,” Dr. Modan-Moses emphasized. On a clinical level, the results highlight the “importance of careful monitoring of height and weight by pediatricians, and early detection and early initiation of treatment of anorexia nervosa in adolescents with long-term efforts to improve and accelerate weight gain in order to prevent complications,” she said. “Research is needed to better define factors affecting catch-up growth (that is improved growth with correction of the height deficit observed at the time of admission) and to determine accordingly optimal treatment plans,” Dr. Modan-Moses added.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Modan-Moses D et al. J Clin Endocrinol Metab. 2020 Aug 20. doi: 10.1210/clinem/dgaa510.

The Food and Drug Administration has approved clascoterone 1% cream for the topical therapy of acne, providing a treatment with a novel mechanism of action for acne.

Clascoterone is a topical androgen receptor inhibitor indicated for treatment of acne vulgaris in patients aged 12 years and older, according to the labeling from manufacturer Cassiopea. Clascoterone, which will be marketed as Winlevi, targets the androgen hormones that contribute to acne by inhibiting serum production and inflammation, according to a company press release.

“Although clascoterone’s exact mechanism of action is unknown, laboratory studies suggest clascoterone competes with androgens, specifically dihydrotestosterone, for binding to the androgen receptors within the sebaceous gland and hair follicles,” according to the release.

Approval was based in part on a pair of phase 3, double-blind, vehicle-controlled, 12-week, randomized trials including 1,440 patients aged 9 years and older with moderate to severe facial acne. The findings were published in April, in JAMA Dermatology .

Participants were randomized to twice-daily application of clascoterone or a control vehicle; treatment success was defined as having an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear), as well as at least a 2-grade improvement from baseline, and absolute change in noninflammatory and inflammatory lesion counts at week 12.

At 12 weeks, treatment success rates were 18.4% and 20.3% among those on clascoterone, compared with 9% and 6.5%, respectively, among controls. There were also significant reductions in noninflammatory and inflammatory lesions from baseline at 12 weeks, compared with controls.

In the studies, treatment was well tolerated, with a safety profile similar to safety in controls. Adverse events thought to be related to clascoterone in the studies (a total of 13) included application-site pain; erythema; oropharyngeal pain; hypersensitivity, dryness, or hypertrichosis at the application site; eye irritation; headache; and hair color changes. “Clascoterone targets androgen receptors at the site of application and is quickly metabolized to an inactive form, thus limiting systemic activity,” the authors of the study wrote.

Clascoterone is expected to be available in the United States in early 2021, according to the manufacturer.

The Food and Drug Administration has approved clascoterone 1% cream for the topical therapy of acne, providing a treatment with a novel mechanism of action for acne.

Clascoterone is a topical androgen receptor inhibitor indicated for treatment of acne vulgaris in patients aged 12 years and older, according to the labeling from manufacturer Cassiopea. Clascoterone, which will be marketed as Winlevi, targets the androgen hormones that contribute to acne by inhibiting serum production and inflammation, according to a company press release.

“Although clascoterone’s exact mechanism of action is unknown, laboratory studies suggest clascoterone competes with androgens, specifically dihydrotestosterone, for binding to the androgen receptors within the sebaceous gland and hair follicles,” according to the release.

Approval was based in part on a pair of phase 3, double-blind, vehicle-controlled, 12-week, randomized trials including 1,440 patients aged 9 years and older with moderate to severe facial acne. The findings were published in April, in JAMA Dermatology .

Participants were randomized to twice-daily application of clascoterone or a control vehicle; treatment success was defined as having an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear), as well as at least a 2-grade improvement from baseline, and absolute change in noninflammatory and inflammatory lesion counts at week 12.

At 12 weeks, treatment success rates were 18.4% and 20.3% among those on clascoterone, compared with 9% and 6.5%, respectively, among controls. There were also significant reductions in noninflammatory and inflammatory lesions from baseline at 12 weeks, compared with controls.

In the studies, treatment was well tolerated, with a safety profile similar to safety in controls. Adverse events thought to be related to clascoterone in the studies (a total of 13) included application-site pain; erythema; oropharyngeal pain; hypersensitivity, dryness, or hypertrichosis at the application site; eye irritation; headache; and hair color changes. “Clascoterone targets androgen receptors at the site of application and is quickly metabolized to an inactive form, thus limiting systemic activity,” the authors of the study wrote.

Clascoterone is expected to be available in the United States in early 2021, according to the manufacturer.

The Food and Drug Administration has approved clascoterone 1% cream for the topical therapy of acne, providing a treatment with a novel mechanism of action for acne.

Clascoterone is a topical androgen receptor inhibitor indicated for treatment of acne vulgaris in patients aged 12 years and older, according to the labeling from manufacturer Cassiopea. Clascoterone, which will be marketed as Winlevi, targets the androgen hormones that contribute to acne by inhibiting serum production and inflammation, according to a company press release.

“Although clascoterone’s exact mechanism of action is unknown, laboratory studies suggest clascoterone competes with androgens, specifically dihydrotestosterone, for binding to the androgen receptors within the sebaceous gland and hair follicles,” according to the release.

Approval was based in part on a pair of phase 3, double-blind, vehicle-controlled, 12-week, randomized trials including 1,440 patients aged 9 years and older with moderate to severe facial acne. The findings were published in April, in JAMA Dermatology .

Participants were randomized to twice-daily application of clascoterone or a control vehicle; treatment success was defined as having an Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear), as well as at least a 2-grade improvement from baseline, and absolute change in noninflammatory and inflammatory lesion counts at week 12.

At 12 weeks, treatment success rates were 18.4% and 20.3% among those on clascoterone, compared with 9% and 6.5%, respectively, among controls. There were also significant reductions in noninflammatory and inflammatory lesions from baseline at 12 weeks, compared with controls.

In the studies, treatment was well tolerated, with a safety profile similar to safety in controls. Adverse events thought to be related to clascoterone in the studies (a total of 13) included application-site pain; erythema; oropharyngeal pain; hypersensitivity, dryness, or hypertrichosis at the application site; eye irritation; headache; and hair color changes. “Clascoterone targets androgen receptors at the site of application and is quickly metabolized to an inactive form, thus limiting systemic activity,” the authors of the study wrote.

Clascoterone is expected to be available in the United States in early 2021, according to the manufacturer.

Children exposed to maternal depression before 5 years of age were 1.17 more likely to experience developmental problems at school entry than were those not exposed, based on data from a cohort study of more than 50,000 children.

Juanmonino/Getty Images

Previous research supports a link between maternal depression and poor cognitive development in children, but the effect of children’s age when exposed to depression on their development has not been well studied, wrote Elizabeth Wall-Wieler, PhD, of Stanford (Calif.) University, and colleagues.

In a population-based cohort study published in Pediatrics, the researchers examined data from 52,103 children born in Manitoba, Canada who completed the Early Development Instrument (EDI) between 2005 and 2016. The EDI is a 103-item questionnaire given to kindergarteners in a classroom setting during the second half of the school year. The EDI is designed to assess five domains: physical health and well-being, social competence, emotional maturity, language and cognitive development, and communication skills and general knowledge. The researchers assessed maternal depression using a combination of physician visits, hospitalizations, and pharmaceutical data; 19% of the children had a mother diagnosed with depression during the study.
 

Difficulties emerged in social functioning, emotion regulation

Children whose mothers had a diagnosis of depression before they reached age 5 years had a 1.17 times increased risk of having a problem in one or more of the developmental domains at school entry, compared with those whose mothers had no such diagnosis. Overall, exposure to maternal depression was significantly associated with problems in the areas of social competence (adjusted risk ratio 1.28), physical health and well-being (aRR 1.28), and emotional maturity (aRR 1.27) in kindergarten. For these three domains, children exposed to maternal depression between the ages of 4 and 5 years showed the greatest risk of developmental vulnerability, the researchers said.

“It is noteworthy that these difficulties were reported by the children’s teachers, avoiding negative biases inherent in having mothers with depression serve as informants,” Dr. Wall-Wieler and associates wrote.

The study findings were limited by several factors related to the observational design, including incomplete data on maternal depression prevalence and severity, the researchers said. In addition, the study did not account for confounding variables related to parenting style and information on the presence and psychiatric profiles of fathers.

The results support previous studies by identifying the impact of exposure to maternal depression on particular developmental domains, the researchers concluded. However, more research is needed to extend their findings.

“In particular, investigators should work to elucidate the mechanisms that underlie this intergenerational transmission to young children of mothers with depression at risk for social and emotional difficulties, focusing on aspects of the caregiving environments and behaviors to which these children are exposed,” Dr. Wall-Wieler and associates concluded.

Approximately 70% of the children exposed to maternal depression did not test as vulnerable in any of the developmental domains. Factors that promoted resilience in the children exposed to maternal depression who did not experience developmental vulnerability should be identified, they noted.
 

Maternal depression is a public health crisis

“The widespread prevalence of maternal depression in the United States and worldwide, with estimates ranging from 3% to 60%, constitutes a public health crisis, particularly one affecting low-income women and their children,” Stephanie Klees Goeglein, MD, and Yvette E. Yatchmink, MD, PhD, of Brown University, Providence, R.I., wrote in an accompanying editorial (Pediatrics. 2020 Aug 17. doi: 10.1542/peds.2020-010413). The study adds to the research and understanding of the negative impact of maternal depression on child development, but also raises questions because some key confounders were not addressed, mainly “the presence of prenatal depression, severity and chronicity of maternal depression, comorbidities, and parenting practices including the involvement of fathers or partners,” they noted.

Don’t discount the impact of prenatal depression, the editorialists stressed. “Surprising to some, prenatal depression is more common than postpartum depression and may be a major, unexplored contributor to the developmental vulnerability of the children in the sample,” Dr. Goeglein and Dr. Yatchmink said.

However, the fact that approximately 70% of the children exposed to maternal depression did not have developmental vulnerability in any domain is encouraging, and speaks to the resiliency of children to overcome adverse conditions, they added.

Pediatricians can play a role in reducing maternal depression by screening mothers starting at a prenatal visit and continuing through post partum, infancy, and beyond. In addition, actions to improve access to mental health care for mothers and to develop culturally-sensitive positive parenting programs may help reduce the effects of depression on mothers and children, Dr. Goeglein and Dr. Yatchmink emphasized.
 

Empower depressed mothers to seek assistance

The results were not surprising, but a study that “validates that which we feel we know is clinically significant,” Lillian M. Beard, MD, of Children’s National in Washington, said in an interview.

“This study restates why it is so important for us to evaluate and recognize maternal depression,” she said. “As a busy pediatrician, once I recognize a problem, I struggle with how to provide viable professional and valuable community resources for these mothers.

“My take-home message from the study is that we must screen for maternal depression. When we suspect maternal depression, it is usually present,” Dr. Beard said. “While we cannot change all the factors that contribute to this condition, to help the children we serve to be physically and emotionally sound, we must help empower their mothers to seek assistance, when needed, to be emotionally healthy,” she emphasized.

“More research is needed to recognize the efficacy and value of community-based assistance for maternal and family depression,” said Dr. Beard, who was not involved with the study and was asked to comment on the findings.

The study was supported by the Canadian Institutes of Health Research, the National Institute of Mental Health, and the National Institutes of Health. The researchers and editorialists had no financial conflicts to disclose. Dr. Beard, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures.

SOURCE: Wall-Wieler E et al. Pediatrics. 2020 Aug 17. doi: 10.1542/peds.2020-0794.

Children exposed to maternal depression before 5 years of age were 1.17 more likely to experience developmental problems at school entry than were those not exposed, based on data from a cohort study of more than 50,000 children.

Juanmonino/Getty Images

Previous research supports a link between maternal depression and poor cognitive development in children, but the effect of children’s age when exposed to depression on their development has not been well studied, wrote Elizabeth Wall-Wieler, PhD, of Stanford (Calif.) University, and colleagues.

In a population-based cohort study published in Pediatrics, the researchers examined data from 52,103 children born in Manitoba, Canada who completed the Early Development Instrument (EDI) between 2005 and 2016. The EDI is a 103-item questionnaire given to kindergarteners in a classroom setting during the second half of the school year. The EDI is designed to assess five domains: physical health and well-being, social competence, emotional maturity, language and cognitive development, and communication skills and general knowledge. The researchers assessed maternal depression using a combination of physician visits, hospitalizations, and pharmaceutical data; 19% of the children had a mother diagnosed with depression during the study.
 

Difficulties emerged in social functioning, emotion regulation

Children whose mothers had a diagnosis of depression before they reached age 5 years had a 1.17 times increased risk of having a problem in one or more of the developmental domains at school entry, compared with those whose mothers had no such diagnosis. Overall, exposure to maternal depression was significantly associated with problems in the areas of social competence (adjusted risk ratio 1.28), physical health and well-being (aRR 1.28), and emotional maturity (aRR 1.27) in kindergarten. For these three domains, children exposed to maternal depression between the ages of 4 and 5 years showed the greatest risk of developmental vulnerability, the researchers said.

“It is noteworthy that these difficulties were reported by the children’s teachers, avoiding negative biases inherent in having mothers with depression serve as informants,” Dr. Wall-Wieler and associates wrote.

The study findings were limited by several factors related to the observational design, including incomplete data on maternal depression prevalence and severity, the researchers said. In addition, the study did not account for confounding variables related to parenting style and information on the presence and psychiatric profiles of fathers.

The results support previous studies by identifying the impact of exposure to maternal depression on particular developmental domains, the researchers concluded. However, more research is needed to extend their findings.

“In particular, investigators should work to elucidate the mechanisms that underlie this intergenerational transmission to young children of mothers with depression at risk for social and emotional difficulties, focusing on aspects of the caregiving environments and behaviors to which these children are exposed,” Dr. Wall-Wieler and associates concluded.

Approximately 70% of the children exposed to maternal depression did not test as vulnerable in any of the developmental domains. Factors that promoted resilience in the children exposed to maternal depression who did not experience developmental vulnerability should be identified, they noted.
 

Maternal depression is a public health crisis

“The widespread prevalence of maternal depression in the United States and worldwide, with estimates ranging from 3% to 60%, constitutes a public health crisis, particularly one affecting low-income women and their children,” Stephanie Klees Goeglein, MD, and Yvette E. Yatchmink, MD, PhD, of Brown University, Providence, R.I., wrote in an accompanying editorial (Pediatrics. 2020 Aug 17. doi: 10.1542/peds.2020-010413). The study adds to the research and understanding of the negative impact of maternal depression on child development, but also raises questions because some key confounders were not addressed, mainly “the presence of prenatal depression, severity and chronicity of maternal depression, comorbidities, and parenting practices including the involvement of fathers or partners,” they noted.

Don’t discount the impact of prenatal depression, the editorialists stressed. “Surprising to some, prenatal depression is more common than postpartum depression and may be a major, unexplored contributor to the developmental vulnerability of the children in the sample,” Dr. Goeglein and Dr. Yatchmink said.

However, the fact that approximately 70% of the children exposed to maternal depression did not have developmental vulnerability in any domain is encouraging, and speaks to the resiliency of children to overcome adverse conditions, they added.

Pediatricians can play a role in reducing maternal depression by screening mothers starting at a prenatal visit and continuing through post partum, infancy, and beyond. In addition, actions to improve access to mental health care for mothers and to develop culturally-sensitive positive parenting programs may help reduce the effects of depression on mothers and children, Dr. Goeglein and Dr. Yatchmink emphasized.
 

Empower depressed mothers to seek assistance

The results were not surprising, but a study that “validates that which we feel we know is clinically significant,” Lillian M. Beard, MD, of Children’s National in Washington, said in an interview.

“This study restates why it is so important for us to evaluate and recognize maternal depression,” she said. “As a busy pediatrician, once I recognize a problem, I struggle with how to provide viable professional and valuable community resources for these mothers.

“My take-home message from the study is that we must screen for maternal depression. When we suspect maternal depression, it is usually present,” Dr. Beard said. “While we cannot change all the factors that contribute to this condition, to help the children we serve to be physically and emotionally sound, we must help empower their mothers to seek assistance, when needed, to be emotionally healthy,” she emphasized.

“More research is needed to recognize the efficacy and value of community-based assistance for maternal and family depression,” said Dr. Beard, who was not involved with the study and was asked to comment on the findings.

The study was supported by the Canadian Institutes of Health Research, the National Institute of Mental Health, and the National Institutes of Health. The researchers and editorialists had no financial conflicts to disclose. Dr. Beard, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures.

SOURCE: Wall-Wieler E et al. Pediatrics. 2020 Aug 17. doi: 10.1542/peds.2020-0794.

Children exposed to maternal depression before 5 years of age were 1.17 more likely to experience developmental problems at school entry than were those not exposed, based on data from a cohort study of more than 50,000 children.

Juanmonino/Getty Images

Previous research supports a link between maternal depression and poor cognitive development in children, but the effect of children’s age when exposed to depression on their development has not been well studied, wrote Elizabeth Wall-Wieler, PhD, of Stanford (Calif.) University, and colleagues.

In a population-based cohort study published in Pediatrics, the researchers examined data from 52,103 children born in Manitoba, Canada who completed the Early Development Instrument (EDI) between 2005 and 2016. The EDI is a 103-item questionnaire given to kindergarteners in a classroom setting during the second half of the school year. The EDI is designed to assess five domains: physical health and well-being, social competence, emotional maturity, language and cognitive development, and communication skills and general knowledge. The researchers assessed maternal depression using a combination of physician visits, hospitalizations, and pharmaceutical data; 19% of the children had a mother diagnosed with depression during the study.
 

Difficulties emerged in social functioning, emotion regulation

Children whose mothers had a diagnosis of depression before they reached age 5 years had a 1.17 times increased risk of having a problem in one or more of the developmental domains at school entry, compared with those whose mothers had no such diagnosis. Overall, exposure to maternal depression was significantly associated with problems in the areas of social competence (adjusted risk ratio 1.28), physical health and well-being (aRR 1.28), and emotional maturity (aRR 1.27) in kindergarten. For these three domains, children exposed to maternal depression between the ages of 4 and 5 years showed the greatest risk of developmental vulnerability, the researchers said.

“It is noteworthy that these difficulties were reported by the children’s teachers, avoiding negative biases inherent in having mothers with depression serve as informants,” Dr. Wall-Wieler and associates wrote.

The study findings were limited by several factors related to the observational design, including incomplete data on maternal depression prevalence and severity, the researchers said. In addition, the study did not account for confounding variables related to parenting style and information on the presence and psychiatric profiles of fathers.

The results support previous studies by identifying the impact of exposure to maternal depression on particular developmental domains, the researchers concluded. However, more research is needed to extend their findings.

“In particular, investigators should work to elucidate the mechanisms that underlie this intergenerational transmission to young children of mothers with depression at risk for social and emotional difficulties, focusing on aspects of the caregiving environments and behaviors to which these children are exposed,” Dr. Wall-Wieler and associates concluded.

Approximately 70% of the children exposed to maternal depression did not test as vulnerable in any of the developmental domains. Factors that promoted resilience in the children exposed to maternal depression who did not experience developmental vulnerability should be identified, they noted.
 

Maternal depression is a public health crisis

“The widespread prevalence of maternal depression in the United States and worldwide, with estimates ranging from 3% to 60%, constitutes a public health crisis, particularly one affecting low-income women and their children,” Stephanie Klees Goeglein, MD, and Yvette E. Yatchmink, MD, PhD, of Brown University, Providence, R.I., wrote in an accompanying editorial (Pediatrics. 2020 Aug 17. doi: 10.1542/peds.2020-010413). The study adds to the research and understanding of the negative impact of maternal depression on child development, but also raises questions because some key confounders were not addressed, mainly “the presence of prenatal depression, severity and chronicity of maternal depression, comorbidities, and parenting practices including the involvement of fathers or partners,” they noted.

Don’t discount the impact of prenatal depression, the editorialists stressed. “Surprising to some, prenatal depression is more common than postpartum depression and may be a major, unexplored contributor to the developmental vulnerability of the children in the sample,” Dr. Goeglein and Dr. Yatchmink said.

However, the fact that approximately 70% of the children exposed to maternal depression did not have developmental vulnerability in any domain is encouraging, and speaks to the resiliency of children to overcome adverse conditions, they added.

Pediatricians can play a role in reducing maternal depression by screening mothers starting at a prenatal visit and continuing through post partum, infancy, and beyond. In addition, actions to improve access to mental health care for mothers and to develop culturally-sensitive positive parenting programs may help reduce the effects of depression on mothers and children, Dr. Goeglein and Dr. Yatchmink emphasized.
 

Empower depressed mothers to seek assistance

The results were not surprising, but a study that “validates that which we feel we know is clinically significant,” Lillian M. Beard, MD, of Children’s National in Washington, said in an interview.

“This study restates why it is so important for us to evaluate and recognize maternal depression,” she said. “As a busy pediatrician, once I recognize a problem, I struggle with how to provide viable professional and valuable community resources for these mothers.

“My take-home message from the study is that we must screen for maternal depression. When we suspect maternal depression, it is usually present,” Dr. Beard said. “While we cannot change all the factors that contribute to this condition, to help the children we serve to be physically and emotionally sound, we must help empower their mothers to seek assistance, when needed, to be emotionally healthy,” she emphasized.

“More research is needed to recognize the efficacy and value of community-based assistance for maternal and family depression,” said Dr. Beard, who was not involved with the study and was asked to comment on the findings.

The study was supported by the Canadian Institutes of Health Research, the National Institute of Mental Health, and the National Institutes of Health. The researchers and editorialists had no financial conflicts to disclose. Dr. Beard, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures.

SOURCE: Wall-Wieler E et al. Pediatrics. 2020 Aug 17. doi: 10.1542/peds.2020-0794.

Obesity in adults with axial spondyloarthritis is associated with significantly worse scores on measures of disease activity when compared with normal-weight patients, according to findings from a meta-analysis of 10 studies.

Obesity or overweight could influence axial spondyloarthritis (axSpA) disease activity in several ways, including production of inflammatory mediators by adipose tissue, joint pain caused by excess weight, loss of muscle mass, and increased atherosclerosis, wrote Augusta Ortolan, MD, of the University of Padova (Italy), and colleagues.

However, “it is less clear whether overweight or obesity per se may be a cause of higher disease activity scores,” they added.

In a systematic review published in Arthritis Care & Research, the investigators identified 10 studies to use in the meta-analysis that involved associations between body mass index (BMI) and disease activity in adults with axSpA. The review included three cohort studies and seven cross-sectional studies of patients aged 18 years and older. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS).

Overall, the mean difference in BASDAI between patients with normal BMI and overweight or obese patients was –0.38 (P < .0001), and the mean difference in ASDAS between the same groups was –0.19 (P < .0001). When separated into overweight and obese categories, only the difference between normal weight and obesity remained significantly associated with differences in scores on both measures (–0.78 and –0.42, respectively; P < .0001 for both measures). The difference in scores between normal-weight and overweight/obese patients increased with BMI categories, which suggests a possible “dose-effect” relationship between fat mass and disease activity, the researchers wrote.

The study findings were limited by several factors, including the lack of randomized, controlled trials, and potential bias and inconsistency involving BMI measurements, the researchers noted.

However, “we were able to mitigate such limitations via a strict methodology and consistency in the outcomes, thus allowing us to use mean differences – instead of standardized mean differences – as outcomes, which are much easier to interpret and can be directly related to the measurement unit of the outcome,” they wrote.

The results extend data from previous studies, which “could help interpret disease activity measures and understand the difference we could expect between an axSpA patient with normal BMI and increased BMI,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Ortolan A et al. Arthritis Care Res. 2020 Aug 16. doi: 10.1002/acr.24416.

Obesity in adults with axial spondyloarthritis is associated with significantly worse scores on measures of disease activity when compared with normal-weight patients, according to findings from a meta-analysis of 10 studies.

Obesity or overweight could influence axial spondyloarthritis (axSpA) disease activity in several ways, including production of inflammatory mediators by adipose tissue, joint pain caused by excess weight, loss of muscle mass, and increased atherosclerosis, wrote Augusta Ortolan, MD, of the University of Padova (Italy), and colleagues.

However, “it is less clear whether overweight or obesity per se may be a cause of higher disease activity scores,” they added.

In a systematic review published in Arthritis Care & Research, the investigators identified 10 studies to use in the meta-analysis that involved associations between body mass index (BMI) and disease activity in adults with axSpA. The review included three cohort studies and seven cross-sectional studies of patients aged 18 years and older. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS).

Overall, the mean difference in BASDAI between patients with normal BMI and overweight or obese patients was –0.38 (P < .0001), and the mean difference in ASDAS between the same groups was –0.19 (P < .0001). When separated into overweight and obese categories, only the difference between normal weight and obesity remained significantly associated with differences in scores on both measures (–0.78 and –0.42, respectively; P < .0001 for both measures). The difference in scores between normal-weight and overweight/obese patients increased with BMI categories, which suggests a possible “dose-effect” relationship between fat mass and disease activity, the researchers wrote.

The study findings were limited by several factors, including the lack of randomized, controlled trials, and potential bias and inconsistency involving BMI measurements, the researchers noted.

However, “we were able to mitigate such limitations via a strict methodology and consistency in the outcomes, thus allowing us to use mean differences – instead of standardized mean differences – as outcomes, which are much easier to interpret and can be directly related to the measurement unit of the outcome,” they wrote.

The results extend data from previous studies, which “could help interpret disease activity measures and understand the difference we could expect between an axSpA patient with normal BMI and increased BMI,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Ortolan A et al. Arthritis Care Res. 2020 Aug 16. doi: 10.1002/acr.24416.

Obesity in adults with axial spondyloarthritis is associated with significantly worse scores on measures of disease activity when compared with normal-weight patients, according to findings from a meta-analysis of 10 studies.

Obesity or overweight could influence axial spondyloarthritis (axSpA) disease activity in several ways, including production of inflammatory mediators by adipose tissue, joint pain caused by excess weight, loss of muscle mass, and increased atherosclerosis, wrote Augusta Ortolan, MD, of the University of Padova (Italy), and colleagues.

However, “it is less clear whether overweight or obesity per se may be a cause of higher disease activity scores,” they added.

In a systematic review published in Arthritis Care & Research, the investigators identified 10 studies to use in the meta-analysis that involved associations between body mass index (BMI) and disease activity in adults with axSpA. The review included three cohort studies and seven cross-sectional studies of patients aged 18 years and older. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Ankylosing Spondylitis Disease Activity Score (ASDAS).

Overall, the mean difference in BASDAI between patients with normal BMI and overweight or obese patients was –0.38 (P < .0001), and the mean difference in ASDAS between the same groups was –0.19 (P < .0001). When separated into overweight and obese categories, only the difference between normal weight and obesity remained significantly associated with differences in scores on both measures (–0.78 and –0.42, respectively; P < .0001 for both measures). The difference in scores between normal-weight and overweight/obese patients increased with BMI categories, which suggests a possible “dose-effect” relationship between fat mass and disease activity, the researchers wrote.

The study findings were limited by several factors, including the lack of randomized, controlled trials, and potential bias and inconsistency involving BMI measurements, the researchers noted.

However, “we were able to mitigate such limitations via a strict methodology and consistency in the outcomes, thus allowing us to use mean differences – instead of standardized mean differences – as outcomes, which are much easier to interpret and can be directly related to the measurement unit of the outcome,” they wrote.

The results extend data from previous studies, which “could help interpret disease activity measures and understand the difference we could expect between an axSpA patient with normal BMI and increased BMI,” they concluded.

The study received no outside funding. The researchers had no financial conflicts to disclose.

SOURCE: Ortolan A et al. Arthritis Care Res. 2020 Aug 16. doi: 10.1002/acr.24416.

The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.

monkeybusinessimages/Thinkstock

“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.

“Importantly, K-12 virtual schooling is not suited for all students or all families.”

In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
 

Not all virtual schools are equal

Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.

“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.

Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).

“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
 

Schools may be able to open safely

Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.

Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.

The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.

“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.

“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”

The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”

“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
 

Schools opening is a regional decision

“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”

“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.

“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”

In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.

“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.

Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”

The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”

“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.

“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
 

It’s not just about education

“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.

“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.

However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”

“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.

“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.

“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”

“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”

“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”

The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”

Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.

The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.

SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
 

The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.

monkeybusinessimages/Thinkstock

“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.

“Importantly, K-12 virtual schooling is not suited for all students or all families.”

In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
 

Not all virtual schools are equal

Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.

“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.

Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).

“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
 

Schools may be able to open safely

Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.

Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.

The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.

“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.

“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”

The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”

“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
 

Schools opening is a regional decision

“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”

“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.

“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”

In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.

“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.

Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”

The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”

“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.

“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
 

It’s not just about education

“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.

“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.

However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”

“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.

“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.

“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”

“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”

“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”

The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”

Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.

The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.

SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.
 

The abrupt transition to online learning for American children in kindergarten through 12th grade has left educators and parents unprepared, but virtual learning can be a successful part of education going forward, according to a viewpoint published in JAMA Pediatrics. However, schools also can reopen safely if precautions are taken, and students would benefit in many ways, according to a second viewpoint.

monkeybusinessimages/Thinkstock

“As policy makers, health care professionals, and parents prepare for the fall semester and as public and private schools grapple with how to make that possible, a better understanding of K-12 virtual learning options and outcomes may facilitate those difficult decisions,” wrote Erik Black, PhD, of the University of Florida, Gainesville; Richard Ferdig, PhD, of Kent State University, Ohio; and Lindsay A. Thompson, MD, of the University of Florida, Gainesville.

“Importantly, K-12 virtual schooling is not suited for all students or all families.”

In a viewpoint published in JAMA Pediatrics, the authors noted that virtual schooling has existed in the United States in various forms for some time. “Just like the myriad options that are available for face-to-face schooling in the U.S., virtual schooling exists in a complex landscape of for-profit, charter, and public options.”
 

Not all virtual schools are equal

Consequently, not all virtual schools are created equal, they emphasized. Virtual education can be successful for many students when presented by trained online instructors using a curriculum designed to be effective in an online venue.

“Parents need to seek reviews and ask for educational outcomes from each virtual school system to assess the quality of the provided education,” Dr. Black, Dr. Ferdig, and Dr. Thompson emphasized.

Key questions for parents to consider when faced with online learning include the type of technology needed to participate; whether their child can maintain a study schedule and complete assignments with limited supervision; whether their child could ask for help and communicate with teachers through technology including phone, text, email, or video; and whether their child has the basic reading, math, and computer literacy skills to engage in online learning, the authors said. Other questions include the school’s expectations for parents and caregivers, how student information may be shared, and how the virtual school lines up with state standards for K-12 educators (in the case of options outside the public school system).

“The COVID-19 pandemic offers a unique challenge for educators, policymakers, and health care professionals to partner with parents to make the best local and individual decisions for children,” Dr. Black, Dr. Ferdig, and Dr. Thompson concluded.
 

Schools may be able to open safely

Children continue to make up a low percentage of COVID-19 cases and appear less likely to experience illness, wrote C. Jason Wang, MD, PhD, and Henry Bair, BS, of Stanford (Calif.) University in a second viewpoint also published in JAMA Pediatrics. The impact of long-term school closures extends beyond education and can “exacerbate socioeconomic disparities, amplify existing educational inequalities, and aggravate food insecurity, domestic violence, and mental health disorders,” they wrote.

Dr. Wang and Mr. Bair proposed that school districts “engage key stakeholders to establish a COVID-19 task force, composed of the superintendent, members of the school board, teachers, parents, and health care professionals to develop policies and procedures,” that would allow schools to open safely.

The authors outlined strategies including adapting teaching spaces to accommodate physical distance, with the addition of temporary modular buildings if needed. They advised assigned seating on school buses, and acknowledged the need for the availability of protective equipment, including hand sanitizer and masks, as well as the possible use of transparent barriers on the sides of student desks.

“As the AAP [American Academy of Pediatrics] guidance suggests, teachers who must work closely with students with special needs or with students who are unable to wear masks should wear N95 masks if possible or wear face shields in addition to surgical masks,” Dr. Wang and Mr. Bair noted. Other elements of the AAP guidance include the creation of fixed cohorts of students and teachers to limit virus exposure.

“Even with all the precautions in place, COVID-19 outbreaks within schools are still likely,” they said. “Therefore, schools will need to remain flexible and consider temporary closures if there is an outbreak involving multiple students and/or staff and be ready to transition to online education.”

The AAP guidance does not address operational approaches to identifying signs and symptoms of COVID-19, the authors noted. “To address this, we recommend that schools implement multilevel screening for students and staff.”

“In summary, to maximize health and educational outcomes, school districts should adopt some or all of the measures of the AAP guidance and prioritize them after considering local COVID-19 incidence, key stakeholder input, and budgetary constraints,” Dr. Wang and Mr. Bair concluded.
 

Schools opening is a regional decision

“The mission of the AAP is to attain optimal physical, mental, and social health and well-being for all infants, children, adolescents, and young adults,” Howard Smart, MD, said in an interview. The question of school reopening “is of national importance, and the AAP has a national role in making recommendations regarding national policy affecting the health of the children.”

“The decision to open schools will be made regionally, but it is important for a nonpolitical national voice to make expert recommendations,” he emphasized.

“Many of the recommendations are ideal goals,” noted Dr. Smart, chairman of the department of pediatrics at the Sharp Rees-Stealy Medical Group in San Diego. “It will be difficult, for example, to implement symptom screening every day before school, no matter where it is performed. Some of the measures may be quite costly, and take time to implement, or require expansion of school staff, for which there may be no budget.”

In addition, “[n]ot all students are likely to comply with masking, distance, and hand-washing recommendations. One student who is noncompliant will be able to infect many other students and staff, as has been seen in other countries.” Also, parental attitudes toward control measures are likely to affect student attitudes, he noted.

“I have interviewed many families at recent checkups, and most have felt that the rush to remote learning that occurred at the end of the last school year resulted in fairly disorganized instruction,” Dr. Smart said. “They are hoping that, having had the summer to plan ahead, the remote teaching will be handled better. Remote learning will certainly work best for self-motivated, organized students with good family support, as noted in the Black, Ferdig, and Thompson article,” he said.

Pediatricians can support the schools by being a source of evidence-based information for parents, Dr. Smart said. “Pediatricians with time and energy might want to volunteer to hold informational video conferences for parents and/or school personnel if they feel they are up to date on current COVID-19 science and want to handle potentially contentious questions.”

The decision parents make to send their children back to school comes down to a risk-benefit calculation. “In some communities this may be left to parents, while in other communities this will a public health decision,” he said. “It is still not clear whether having students attend school in person will result in increased spread of COVID-19 among the students, or in their communities. Although some evidence from early in the pandemic suggests that children may not spread the virus as much as adults, more recent evidence suggests that children 10 years and older do transmit the virus at least as much as adults.”

“The risk to the students and the community, therefore, is unknown,” and difficult to compare with the benefit of in-person schooling, Dr. Smart noted.

“We will learn quite a bit from communities where students do go back to in-person class, as we follow the progression of COVID-19 over the weeks following the resumption of instruction.” Ultimately, advice to parents will need to be tailored to the current conditions of COVID-19 transmission in the community, he concluded.
 

It’s not just about education

“The AAP released its guidance to ensure that as school districts were contemplating reopening they were considering the full array of risks for children and adolescents. These risks included not only those related to COVID-19, but also those related to the impact of not reopening in-person,” Nathaniel Beers, MD, president of the HSC Health Care System in Washington, said in an interview.

“Students and families are dependent on schools for much more than just an education, and those [elements] need to be factored into the decisions to reopen,” the pediatrician said.

However, “[t]he major barrier for schools is resources to safely reopen,” said Dr. Beers. “The additional staffing and supplies will require additional funding. There are increased demands regardless of whether students are learning in-person or virtually or through hybrid models.”

“Another significant barrier is ensuring that parents and staff are actively engaged in planning for the type of model being used,” he said.

“All of the models require buy-in by staff and parents. This will require significant outreach and strong communication plans. Schools also need to ensure they are planning not just for how to return students to schools, but what will happen when staff or students test positive for COVID-19. Students, families, and staff all will need to know what these plans are up front to feel confident in returning to school,” he emphasized.

“There are students who can thrive in a virtual learning environment,” Dr. Beers said. “There are also students who benefit from the virtual learning environment because of their own risk, or because of a family member’s risk for COVID-19 or the complications from it.”

“However, many children with disabilities have struggled in a virtual environment,” he said. “These students struggle to access the educational services without the adequate supports at home. They often receive additional services in school, such as speech, occupational therapy or physical therapy, or nursing services, that may not have transitioned to home but are critical for their health and development. Many students with disabilities are dependent on family members to successfully access the educational services they need.”

“Pediatricians can play a role in providing feedback on recommendations related to physical distancing and face coverings in particular,” said Dr. Beers. “In addition, they can be helpful in developing plans for children with disabilities as well as what the response plan should be for students who become sick during the school day.”

The Centers for Disease Control and Prevention released a decision tool for parents who are considering whether to send their child to in-person school, and pediatricians can help parents walk through these questions, Dr. Beers noted. “In addition, pediatricians play an important role in helping patients and families think about the risks of COVID for the patient and other family members, and this can be helpful in addressing the anxiety that parents and patients may be experiencing.”

Further information can be found in Return to School During COVID-19, which can be located at HealthyChildren.org, by the American Academy of Pediatrics.

The authors of the viewpoints had no relevant financial disclosures. Dr. Smart, a member of the Pediatric News editorial advisory board, had no relevant financial disclosures. Dr. Beers has served on the editorial advisory board of Pediatric News in the past, but had no relevant financial disclosures.

SOURCES: Black E, Ferdig R, Thompson LA. JAMA Pediatr. 2020 Aug 11. doi: 10.1001/jamapediatrics.2020.3800. Wang CJ and Bair H. JAMA Pediatr. Aug 11. doi: 10.1001/jamapediatrics.2020.3871.