User login
School antibullying programs may have substantial population impact
School antibullying programs may have small effect sizes but a valuable population impact, according to research published in JAMA Pediatrics.
.
The investigators estimated population effect numbers for the interventions, such as the number of students needed to participate in an antibullying program to prevent one case of bullying.
Assuming a bullying prevalence of 15%, “an average antibullying intervention needs to include 207 people to prevent 1 case of bullying perpetration or 140 people to prevent 1 case of bullying exposure,” reported David Fraguas, MD, PhD, of the Institute of Psychiatry and Mental Health at Hospital Clínico San Carlos in Madrid, and colleagues. To improve mental health, the average antibullying program needs to include 107 people, the results indicate.
Few trials assessed the same antibullying program, so the researchers examined antibullying programs as a whole. Still, “not all antibullying programs are efficacious,” and “effectiveness may vary in different settings,” they noted.
Public health implications
Schools frequently implement programs to address bullying, which research suggests is a prevalent, modifiable risk factor for mental health disorders and therefore a “major public health concern,” the authors said. Studies have suggested that antibullying programs may be effective, though the evidence has been unclear.
“I see teens with mental health issues frequently in my practice, and often during their assessment, these patients and parents disclose a history of bullying at school or online,” said Kelly A. Curran, MD, associate professor of pediatrics at the University of Oklahoma, Oklahoma City. “The impact of bullying on these teens is obvious – from the mental health issues to school absenteeism and dropouts to long-term health consequences. Often, parents ask for guidance on how to ‘make it stop’ or for help working with the teen’s school. It’s hard in these cases as a clinician to know what to recommend – while it’s clear that the bullying is contributing to the teen’s health issues, giving evidenced-based guidance on bullying has been difficult.”
Dr. Curran had been “somewhat skeptical” of the effectiveness of antibullying curricula.
“I was pleasantly surprised to see that there is a significant population impact for interventions to prevent traditional bullying (207 people educated to prevent 1 case) and cyberbullying (167 people educated to prevent 1 case),” Dr. Curran said. “Additionally, these interventions do not have to be lengthy in duration – and may have long-term effectiveness. While there are limitations to this study, I feel more comfortable recommending and advocating for antibullying campaigns in schools.”
Relative to control groups
To assess the population impact of antibullying interventions, Dr. Fraguas and collaborators conducted random-effects meta-analyses. They identified 69 trials that included 56,511 participants in intervention groups and 55,148 in control groups. Five of the trials tested interventions targeting cyberbullying.
Participants ranged in age from 4 to 17 years, and the weighted average age was 11 years. The durations of the interventions ranged from 1 week to more than 2 years, with an average duration of 29.4 weeks.
“Antibullying interventions showed statistically significant effectiveness compared with control groups on all assessed bullying-related outcomes after the intervention,” the researchers reported. “The effect sizes were mostly statistically significant and small ... with high statistical heterogeneity and risk of publication bias. Antibullying interventions also showed statistically significant effectiveness in improving mental health problems (e.g., anxiety and depression) at study endpoint, with small effect size.”
Consistent with prior research, results varied by region. For example, interventions in Europe, where 31 of the trials were conducted, significantly decreased bullying exposure and attitudes that encourage bullying, whereas interventions in North America, where 19 of the trials were conducted, did not. In addition, European trials found greater effect sizes for the outcome measure of increasing attitudes that discourage bullying, compared with North American trials. The regional differences could reflect different programs or study designs, or differences in “social, educational, or cultural context,” the authors said.
‘Substantial’ impact
Together, the findings suggest that “universal antibullying interventions have a substantial population impact,” Dr. Fraguas and coauthors wrote. “To put these results into context, the [population impact number] is 35,450 for taking aspirin to avoid 1 death during the 6 months after a first nonhemorrhagic stroke, and the [population impact number] is 324 for human papillomavirus vaccination in girls to prevent cervical cancer.”
Furthermore, the interventions appear to be safe, they said. None of the trials in the meta-analysis reported an increase in bullying perpetration or bullying exposure at the end of the study or during follow-up, and mental health improved in all trials that assessed that outcome.
Pediatricians may be seen as resource
“From our survey work among parents all across Chicago, we know that almost one-half of all parents with children in school are concerned that their children get bullied,” said Matthew M. Davis, MD chair of the department of pediatrics at Ann & Robert H. Lurie Children’s Hospital of Chicago and professor of pediatrics, medicine, medical social sciences, and preventive medicine at Northwestern University in Chicago. “Among those parents, about one-half sought help from a teacher and about one-third asked a school administrator or school social worker for help. That means that schools are, by far, the go-to source for help when parents are worried about bullying.”
The survey of 1,642 parents in Chicago also found that 20% of parents with concerns sought help from mental health care providers, and 16% sought help from their pediatricians.
“Pediatricians can provide psychosocial support for their patients who are being bullied,” Dr. Davis said. “They can also talk with patients and their parents/guardians about how to team up with school personnel to address the bullying in the school environment.”
The meta-analysis was supported by grants from Instituto de Salud Carlos III (Spanish Ministry of Science and Innovation), cofinanced by the European Regional Development Fund from the European Commission. It also was supported by Madrid Regional Government, European Union programs, Fundación Familia Alonso, Fundación Alicia Koplowitz, and Fundación Mutua Madrileña.
Dr. Fraguas disclosed consulting for or receiving fees from Angelini, Eisai, IE4Lab, Janssen, Lundbeck, and Otsuka and grant support from Fundación Alicia Koplowitz and Instituto de Salud Carlos III. Coauthors disclosed financial ties to pharmaceutical companies, as well as government and foundation grants. Dr. Curran is a member of the Pediatric News editorial advisory board. Dr. Davis had no relevant disclosures.
School antibullying programs may have small effect sizes but a valuable population impact, according to research published in JAMA Pediatrics.
.
The investigators estimated population effect numbers for the interventions, such as the number of students needed to participate in an antibullying program to prevent one case of bullying.
Assuming a bullying prevalence of 15%, “an average antibullying intervention needs to include 207 people to prevent 1 case of bullying perpetration or 140 people to prevent 1 case of bullying exposure,” reported David Fraguas, MD, PhD, of the Institute of Psychiatry and Mental Health at Hospital Clínico San Carlos in Madrid, and colleagues. To improve mental health, the average antibullying program needs to include 107 people, the results indicate.
Few trials assessed the same antibullying program, so the researchers examined antibullying programs as a whole. Still, “not all antibullying programs are efficacious,” and “effectiveness may vary in different settings,” they noted.
Public health implications
Schools frequently implement programs to address bullying, which research suggests is a prevalent, modifiable risk factor for mental health disorders and therefore a “major public health concern,” the authors said. Studies have suggested that antibullying programs may be effective, though the evidence has been unclear.
“I see teens with mental health issues frequently in my practice, and often during their assessment, these patients and parents disclose a history of bullying at school or online,” said Kelly A. Curran, MD, associate professor of pediatrics at the University of Oklahoma, Oklahoma City. “The impact of bullying on these teens is obvious – from the mental health issues to school absenteeism and dropouts to long-term health consequences. Often, parents ask for guidance on how to ‘make it stop’ or for help working with the teen’s school. It’s hard in these cases as a clinician to know what to recommend – while it’s clear that the bullying is contributing to the teen’s health issues, giving evidenced-based guidance on bullying has been difficult.”
Dr. Curran had been “somewhat skeptical” of the effectiveness of antibullying curricula.
“I was pleasantly surprised to see that there is a significant population impact for interventions to prevent traditional bullying (207 people educated to prevent 1 case) and cyberbullying (167 people educated to prevent 1 case),” Dr. Curran said. “Additionally, these interventions do not have to be lengthy in duration – and may have long-term effectiveness. While there are limitations to this study, I feel more comfortable recommending and advocating for antibullying campaigns in schools.”
Relative to control groups
To assess the population impact of antibullying interventions, Dr. Fraguas and collaborators conducted random-effects meta-analyses. They identified 69 trials that included 56,511 participants in intervention groups and 55,148 in control groups. Five of the trials tested interventions targeting cyberbullying.
Participants ranged in age from 4 to 17 years, and the weighted average age was 11 years. The durations of the interventions ranged from 1 week to more than 2 years, with an average duration of 29.4 weeks.
“Antibullying interventions showed statistically significant effectiveness compared with control groups on all assessed bullying-related outcomes after the intervention,” the researchers reported. “The effect sizes were mostly statistically significant and small ... with high statistical heterogeneity and risk of publication bias. Antibullying interventions also showed statistically significant effectiveness in improving mental health problems (e.g., anxiety and depression) at study endpoint, with small effect size.”
Consistent with prior research, results varied by region. For example, interventions in Europe, where 31 of the trials were conducted, significantly decreased bullying exposure and attitudes that encourage bullying, whereas interventions in North America, where 19 of the trials were conducted, did not. In addition, European trials found greater effect sizes for the outcome measure of increasing attitudes that discourage bullying, compared with North American trials. The regional differences could reflect different programs or study designs, or differences in “social, educational, or cultural context,” the authors said.
‘Substantial’ impact
Together, the findings suggest that “universal antibullying interventions have a substantial population impact,” Dr. Fraguas and coauthors wrote. “To put these results into context, the [population impact number] is 35,450 for taking aspirin to avoid 1 death during the 6 months after a first nonhemorrhagic stroke, and the [population impact number] is 324 for human papillomavirus vaccination in girls to prevent cervical cancer.”
Furthermore, the interventions appear to be safe, they said. None of the trials in the meta-analysis reported an increase in bullying perpetration or bullying exposure at the end of the study or during follow-up, and mental health improved in all trials that assessed that outcome.
Pediatricians may be seen as resource
“From our survey work among parents all across Chicago, we know that almost one-half of all parents with children in school are concerned that their children get bullied,” said Matthew M. Davis, MD chair of the department of pediatrics at Ann & Robert H. Lurie Children’s Hospital of Chicago and professor of pediatrics, medicine, medical social sciences, and preventive medicine at Northwestern University in Chicago. “Among those parents, about one-half sought help from a teacher and about one-third asked a school administrator or school social worker for help. That means that schools are, by far, the go-to source for help when parents are worried about bullying.”
The survey of 1,642 parents in Chicago also found that 20% of parents with concerns sought help from mental health care providers, and 16% sought help from their pediatricians.
“Pediatricians can provide psychosocial support for their patients who are being bullied,” Dr. Davis said. “They can also talk with patients and their parents/guardians about how to team up with school personnel to address the bullying in the school environment.”
The meta-analysis was supported by grants from Instituto de Salud Carlos III (Spanish Ministry of Science and Innovation), cofinanced by the European Regional Development Fund from the European Commission. It also was supported by Madrid Regional Government, European Union programs, Fundación Familia Alonso, Fundación Alicia Koplowitz, and Fundación Mutua Madrileña.
Dr. Fraguas disclosed consulting for or receiving fees from Angelini, Eisai, IE4Lab, Janssen, Lundbeck, and Otsuka and grant support from Fundación Alicia Koplowitz and Instituto de Salud Carlos III. Coauthors disclosed financial ties to pharmaceutical companies, as well as government and foundation grants. Dr. Curran is a member of the Pediatric News editorial advisory board. Dr. Davis had no relevant disclosures.
School antibullying programs may have small effect sizes but a valuable population impact, according to research published in JAMA Pediatrics.
.
The investigators estimated population effect numbers for the interventions, such as the number of students needed to participate in an antibullying program to prevent one case of bullying.
Assuming a bullying prevalence of 15%, “an average antibullying intervention needs to include 207 people to prevent 1 case of bullying perpetration or 140 people to prevent 1 case of bullying exposure,” reported David Fraguas, MD, PhD, of the Institute of Psychiatry and Mental Health at Hospital Clínico San Carlos in Madrid, and colleagues. To improve mental health, the average antibullying program needs to include 107 people, the results indicate.
Few trials assessed the same antibullying program, so the researchers examined antibullying programs as a whole. Still, “not all antibullying programs are efficacious,” and “effectiveness may vary in different settings,” they noted.
Public health implications
Schools frequently implement programs to address bullying, which research suggests is a prevalent, modifiable risk factor for mental health disorders and therefore a “major public health concern,” the authors said. Studies have suggested that antibullying programs may be effective, though the evidence has been unclear.
“I see teens with mental health issues frequently in my practice, and often during their assessment, these patients and parents disclose a history of bullying at school or online,” said Kelly A. Curran, MD, associate professor of pediatrics at the University of Oklahoma, Oklahoma City. “The impact of bullying on these teens is obvious – from the mental health issues to school absenteeism and dropouts to long-term health consequences. Often, parents ask for guidance on how to ‘make it stop’ or for help working with the teen’s school. It’s hard in these cases as a clinician to know what to recommend – while it’s clear that the bullying is contributing to the teen’s health issues, giving evidenced-based guidance on bullying has been difficult.”
Dr. Curran had been “somewhat skeptical” of the effectiveness of antibullying curricula.
“I was pleasantly surprised to see that there is a significant population impact for interventions to prevent traditional bullying (207 people educated to prevent 1 case) and cyberbullying (167 people educated to prevent 1 case),” Dr. Curran said. “Additionally, these interventions do not have to be lengthy in duration – and may have long-term effectiveness. While there are limitations to this study, I feel more comfortable recommending and advocating for antibullying campaigns in schools.”
Relative to control groups
To assess the population impact of antibullying interventions, Dr. Fraguas and collaborators conducted random-effects meta-analyses. They identified 69 trials that included 56,511 participants in intervention groups and 55,148 in control groups. Five of the trials tested interventions targeting cyberbullying.
Participants ranged in age from 4 to 17 years, and the weighted average age was 11 years. The durations of the interventions ranged from 1 week to more than 2 years, with an average duration of 29.4 weeks.
“Antibullying interventions showed statistically significant effectiveness compared with control groups on all assessed bullying-related outcomes after the intervention,” the researchers reported. “The effect sizes were mostly statistically significant and small ... with high statistical heterogeneity and risk of publication bias. Antibullying interventions also showed statistically significant effectiveness in improving mental health problems (e.g., anxiety and depression) at study endpoint, with small effect size.”
Consistent with prior research, results varied by region. For example, interventions in Europe, where 31 of the trials were conducted, significantly decreased bullying exposure and attitudes that encourage bullying, whereas interventions in North America, where 19 of the trials were conducted, did not. In addition, European trials found greater effect sizes for the outcome measure of increasing attitudes that discourage bullying, compared with North American trials. The regional differences could reflect different programs or study designs, or differences in “social, educational, or cultural context,” the authors said.
‘Substantial’ impact
Together, the findings suggest that “universal antibullying interventions have a substantial population impact,” Dr. Fraguas and coauthors wrote. “To put these results into context, the [population impact number] is 35,450 for taking aspirin to avoid 1 death during the 6 months after a first nonhemorrhagic stroke, and the [population impact number] is 324 for human papillomavirus vaccination in girls to prevent cervical cancer.”
Furthermore, the interventions appear to be safe, they said. None of the trials in the meta-analysis reported an increase in bullying perpetration or bullying exposure at the end of the study or during follow-up, and mental health improved in all trials that assessed that outcome.
Pediatricians may be seen as resource
“From our survey work among parents all across Chicago, we know that almost one-half of all parents with children in school are concerned that their children get bullied,” said Matthew M. Davis, MD chair of the department of pediatrics at Ann & Robert H. Lurie Children’s Hospital of Chicago and professor of pediatrics, medicine, medical social sciences, and preventive medicine at Northwestern University in Chicago. “Among those parents, about one-half sought help from a teacher and about one-third asked a school administrator or school social worker for help. That means that schools are, by far, the go-to source for help when parents are worried about bullying.”
The survey of 1,642 parents in Chicago also found that 20% of parents with concerns sought help from mental health care providers, and 16% sought help from their pediatricians.
“Pediatricians can provide psychosocial support for their patients who are being bullied,” Dr. Davis said. “They can also talk with patients and their parents/guardians about how to team up with school personnel to address the bullying in the school environment.”
The meta-analysis was supported by grants from Instituto de Salud Carlos III (Spanish Ministry of Science and Innovation), cofinanced by the European Regional Development Fund from the European Commission. It also was supported by Madrid Regional Government, European Union programs, Fundación Familia Alonso, Fundación Alicia Koplowitz, and Fundación Mutua Madrileña.
Dr. Fraguas disclosed consulting for or receiving fees from Angelini, Eisai, IE4Lab, Janssen, Lundbeck, and Otsuka and grant support from Fundación Alicia Koplowitz and Instituto de Salud Carlos III. Coauthors disclosed financial ties to pharmaceutical companies, as well as government and foundation grants. Dr. Curran is a member of the Pediatric News editorial advisory board. Dr. Davis had no relevant disclosures.
FROM JAMA PEDIATRICS
Which providers miss metabolic monitoring of children taking antipsychotics?
The number and types of providers involved in a child’s care are associated with the likelihood that the child will receive metabolic monitoring, according to the study, which was published in Pediatrics.
The results suggest that primary care providers and mental health providers should collaborate to monitor children taking antipsychotics, the researchers said.
“Shared care arrangements between primary care physicians and mental health specialists significantly increased the chances that metabolic monitoring would be done, compared with care delivered by one provider,” reported Elizabeth A. Shenkman, PhD, chair of the department of health outcomes and biomedical informatics at the University of Florida, Gainesville, and colleagues. “The results of our study point to the importance of state Medicaid agencies and Medicaid managed care plans in identifying all providers caring for the children taking antipsychotic medication and using this information to engage the providers in quality improvement efforts to improve metabolic monitoring rates.”
Comparing specialties
Children who take antipsychotic medication are at risk for obesity, impaired glucose metabolism, and hyperlipidemia, but less than 40% receive recommended metabolic monitoring with glucose and cholesterol tests.
To examine how health care provider specialty influences the receipt of metabolic monitoring, Dr. Shenkman and colleagues analyzed Medicaid enrollment and health care and pharmacy claims data from Florida and Texas.
They focused on 41,078 children who had an antipsychotic medication dispensed at least twice in 2017 and were eligible for inclusion in the Centers for Medicare & Medicaid Services metabolic monitoring measure. The Metabolic Monitoring for Children and Adolescents on Antipsychotics measure is a “priority nationally and is currently on the CMS Child Core Set, which is used to annually assess state-specific performance on pediatric quality measures,” the authors wrote.
About 65% were boys, and the children had an average age of 12 years. The researchers compared metabolic monitoring rates when children received outpatient care from a primary care provider, a mental health provider with prescribing privileges, or both.
Less than 40% of the children received metabolic monitoring, that is, at least one diabetes test and at least one cholesterol test, during the year.
Most of the children (61%) saw both primary care providers and mental health providers. Approximately one-third had a primary care provider prescribe antipsychotic medication the majority of the time, and 60% had a mental health provider prescribe antipsychotic medication the majority of the time.
Patients who saw both types of providers were significantly more likely to receive metabolic monitoring, relative to those who saw primary care providers only (adjusted odds ratio, 1.42). Those seeing a mental health provider alone had adjusted odds of metabolic monitoring that were 23% lower than those seeing a primary care provider alone.
Children who had a mental health provider prescribe the medication the majority of the time were 25% more likely to receive metabolic monitoring, compared with those who had a primary care provider prescribing the medication the majority of the time.
Slipping through the cracks
Child psychiatrist Fred Volkmar, MD, commented that the results are “sadly” unsurprising and reflect issues that pertain to other psychotropic drugs as well as antipsychotics and to adults as well as children.
The researchers “are quite right to point to it,” and “we really do need to develop better plans for improving” monitoring, said Dr. Volkmar, the Irving B. Harris Professor in the Child Study Center and professor of psychology at Yale University, New Haven, Conn.
“Increasingly we are asking primary care providers ... to take care of folks who have important either developmental or mental health problems,” Dr. Volkmar said. While they can do a good job, they increasingly are underpaid. Monitoring patients takes work, and they may be less familiar with the medications. “Either they prescribe these medications or they are asked to monitor them in place of the specialist provider who may have started them or suggested them,” he said. Metabolic monitoring may not be prioritized and can easily “slip through the cracks.” At the same time, doctors need to be aware of the risk of serious side effects of antipsychotic medications, such as malignant hyperthermia.
These medications can be overused and inappropriately used, which is a further complication. And when patients are taking multiple medications, there may be a need for additional monitoring and awareness of drug interactions.
“These medications are very complicated to use,” and there needs to be a way to connect primary care providers with child psychiatrists who are best trained in their use, said Dr. Volkmar.
A system with reminders can facilitate effective metabolic monitoring, he suggested. Dr. Volkmar has established a routine while providing care for a group home of adults with autism. Every 3 months, he reviews lab results. “You just have to force yourself to do it.”
Shared care arrangements may be another way to promote metabolic monitoring, Dr. Shenkman and colleagues said.
“Attributing care back to the multiple providers is important for care coordination and development of strategies to ensure that the evidence-based care is delivered and there is appropriate follow-up with the family and child to be sure care is received,” the study authors wrote. “Formalized shared care arrangements and adaptation of existing care delivery models to support integrated care, which can vary in degree from external coordination to on-site intervention and collaboration, are effective methods to promote partnership between primary and mental health providers.”
It is possible that clinicians in the study ordered metabolic monitoring but families did not take the children for testing, the investigators noted. In addition, it is not clear how much information providers have about other providers their patients are seeing.
The study authors and Dr. Volkmar had no disclosures.
The number and types of providers involved in a child’s care are associated with the likelihood that the child will receive metabolic monitoring, according to the study, which was published in Pediatrics.
The results suggest that primary care providers and mental health providers should collaborate to monitor children taking antipsychotics, the researchers said.
“Shared care arrangements between primary care physicians and mental health specialists significantly increased the chances that metabolic monitoring would be done, compared with care delivered by one provider,” reported Elizabeth A. Shenkman, PhD, chair of the department of health outcomes and biomedical informatics at the University of Florida, Gainesville, and colleagues. “The results of our study point to the importance of state Medicaid agencies and Medicaid managed care plans in identifying all providers caring for the children taking antipsychotic medication and using this information to engage the providers in quality improvement efforts to improve metabolic monitoring rates.”
Comparing specialties
Children who take antipsychotic medication are at risk for obesity, impaired glucose metabolism, and hyperlipidemia, but less than 40% receive recommended metabolic monitoring with glucose and cholesterol tests.
To examine how health care provider specialty influences the receipt of metabolic monitoring, Dr. Shenkman and colleagues analyzed Medicaid enrollment and health care and pharmacy claims data from Florida and Texas.
They focused on 41,078 children who had an antipsychotic medication dispensed at least twice in 2017 and were eligible for inclusion in the Centers for Medicare & Medicaid Services metabolic monitoring measure. The Metabolic Monitoring for Children and Adolescents on Antipsychotics measure is a “priority nationally and is currently on the CMS Child Core Set, which is used to annually assess state-specific performance on pediatric quality measures,” the authors wrote.
About 65% were boys, and the children had an average age of 12 years. The researchers compared metabolic monitoring rates when children received outpatient care from a primary care provider, a mental health provider with prescribing privileges, or both.
Less than 40% of the children received metabolic monitoring, that is, at least one diabetes test and at least one cholesterol test, during the year.
Most of the children (61%) saw both primary care providers and mental health providers. Approximately one-third had a primary care provider prescribe antipsychotic medication the majority of the time, and 60% had a mental health provider prescribe antipsychotic medication the majority of the time.
Patients who saw both types of providers were significantly more likely to receive metabolic monitoring, relative to those who saw primary care providers only (adjusted odds ratio, 1.42). Those seeing a mental health provider alone had adjusted odds of metabolic monitoring that were 23% lower than those seeing a primary care provider alone.
Children who had a mental health provider prescribe the medication the majority of the time were 25% more likely to receive metabolic monitoring, compared with those who had a primary care provider prescribing the medication the majority of the time.
Slipping through the cracks
Child psychiatrist Fred Volkmar, MD, commented that the results are “sadly” unsurprising and reflect issues that pertain to other psychotropic drugs as well as antipsychotics and to adults as well as children.
The researchers “are quite right to point to it,” and “we really do need to develop better plans for improving” monitoring, said Dr. Volkmar, the Irving B. Harris Professor in the Child Study Center and professor of psychology at Yale University, New Haven, Conn.
“Increasingly we are asking primary care providers ... to take care of folks who have important either developmental or mental health problems,” Dr. Volkmar said. While they can do a good job, they increasingly are underpaid. Monitoring patients takes work, and they may be less familiar with the medications. “Either they prescribe these medications or they are asked to monitor them in place of the specialist provider who may have started them or suggested them,” he said. Metabolic monitoring may not be prioritized and can easily “slip through the cracks.” At the same time, doctors need to be aware of the risk of serious side effects of antipsychotic medications, such as malignant hyperthermia.
These medications can be overused and inappropriately used, which is a further complication. And when patients are taking multiple medications, there may be a need for additional monitoring and awareness of drug interactions.
“These medications are very complicated to use,” and there needs to be a way to connect primary care providers with child psychiatrists who are best trained in their use, said Dr. Volkmar.
A system with reminders can facilitate effective metabolic monitoring, he suggested. Dr. Volkmar has established a routine while providing care for a group home of adults with autism. Every 3 months, he reviews lab results. “You just have to force yourself to do it.”
Shared care arrangements may be another way to promote metabolic monitoring, Dr. Shenkman and colleagues said.
“Attributing care back to the multiple providers is important for care coordination and development of strategies to ensure that the evidence-based care is delivered and there is appropriate follow-up with the family and child to be sure care is received,” the study authors wrote. “Formalized shared care arrangements and adaptation of existing care delivery models to support integrated care, which can vary in degree from external coordination to on-site intervention and collaboration, are effective methods to promote partnership between primary and mental health providers.”
It is possible that clinicians in the study ordered metabolic monitoring but families did not take the children for testing, the investigators noted. In addition, it is not clear how much information providers have about other providers their patients are seeing.
The study authors and Dr. Volkmar had no disclosures.
The number and types of providers involved in a child’s care are associated with the likelihood that the child will receive metabolic monitoring, according to the study, which was published in Pediatrics.
The results suggest that primary care providers and mental health providers should collaborate to monitor children taking antipsychotics, the researchers said.
“Shared care arrangements between primary care physicians and mental health specialists significantly increased the chances that metabolic monitoring would be done, compared with care delivered by one provider,” reported Elizabeth A. Shenkman, PhD, chair of the department of health outcomes and biomedical informatics at the University of Florida, Gainesville, and colleagues. “The results of our study point to the importance of state Medicaid agencies and Medicaid managed care plans in identifying all providers caring for the children taking antipsychotic medication and using this information to engage the providers in quality improvement efforts to improve metabolic monitoring rates.”
Comparing specialties
Children who take antipsychotic medication are at risk for obesity, impaired glucose metabolism, and hyperlipidemia, but less than 40% receive recommended metabolic monitoring with glucose and cholesterol tests.
To examine how health care provider specialty influences the receipt of metabolic monitoring, Dr. Shenkman and colleagues analyzed Medicaid enrollment and health care and pharmacy claims data from Florida and Texas.
They focused on 41,078 children who had an antipsychotic medication dispensed at least twice in 2017 and were eligible for inclusion in the Centers for Medicare & Medicaid Services metabolic monitoring measure. The Metabolic Monitoring for Children and Adolescents on Antipsychotics measure is a “priority nationally and is currently on the CMS Child Core Set, which is used to annually assess state-specific performance on pediatric quality measures,” the authors wrote.
About 65% were boys, and the children had an average age of 12 years. The researchers compared metabolic monitoring rates when children received outpatient care from a primary care provider, a mental health provider with prescribing privileges, or both.
Less than 40% of the children received metabolic monitoring, that is, at least one diabetes test and at least one cholesterol test, during the year.
Most of the children (61%) saw both primary care providers and mental health providers. Approximately one-third had a primary care provider prescribe antipsychotic medication the majority of the time, and 60% had a mental health provider prescribe antipsychotic medication the majority of the time.
Patients who saw both types of providers were significantly more likely to receive metabolic monitoring, relative to those who saw primary care providers only (adjusted odds ratio, 1.42). Those seeing a mental health provider alone had adjusted odds of metabolic monitoring that were 23% lower than those seeing a primary care provider alone.
Children who had a mental health provider prescribe the medication the majority of the time were 25% more likely to receive metabolic monitoring, compared with those who had a primary care provider prescribing the medication the majority of the time.
Slipping through the cracks
Child psychiatrist Fred Volkmar, MD, commented that the results are “sadly” unsurprising and reflect issues that pertain to other psychotropic drugs as well as antipsychotics and to adults as well as children.
The researchers “are quite right to point to it,” and “we really do need to develop better plans for improving” monitoring, said Dr. Volkmar, the Irving B. Harris Professor in the Child Study Center and professor of psychology at Yale University, New Haven, Conn.
“Increasingly we are asking primary care providers ... to take care of folks who have important either developmental or mental health problems,” Dr. Volkmar said. While they can do a good job, they increasingly are underpaid. Monitoring patients takes work, and they may be less familiar with the medications. “Either they prescribe these medications or they are asked to monitor them in place of the specialist provider who may have started them or suggested them,” he said. Metabolic monitoring may not be prioritized and can easily “slip through the cracks.” At the same time, doctors need to be aware of the risk of serious side effects of antipsychotic medications, such as malignant hyperthermia.
These medications can be overused and inappropriately used, which is a further complication. And when patients are taking multiple medications, there may be a need for additional monitoring and awareness of drug interactions.
“These medications are very complicated to use,” and there needs to be a way to connect primary care providers with child psychiatrists who are best trained in their use, said Dr. Volkmar.
A system with reminders can facilitate effective metabolic monitoring, he suggested. Dr. Volkmar has established a routine while providing care for a group home of adults with autism. Every 3 months, he reviews lab results. “You just have to force yourself to do it.”
Shared care arrangements may be another way to promote metabolic monitoring, Dr. Shenkman and colleagues said.
“Attributing care back to the multiple providers is important for care coordination and development of strategies to ensure that the evidence-based care is delivered and there is appropriate follow-up with the family and child to be sure care is received,” the study authors wrote. “Formalized shared care arrangements and adaptation of existing care delivery models to support integrated care, which can vary in degree from external coordination to on-site intervention and collaboration, are effective methods to promote partnership between primary and mental health providers.”
It is possible that clinicians in the study ordered metabolic monitoring but families did not take the children for testing, the investigators noted. In addition, it is not clear how much information providers have about other providers their patients are seeing.
The study authors and Dr. Volkmar had no disclosures.
FROM PEDIATRICS
Greater reductions in knee OA pain seen with supportive rather than flexible shoes
according to a randomized trial that included more than 160 patients.
“Contrary to our hypothesis, flat flexible shoes were not superior to stable supportive shoes,” reported Kade L. Paterson, PhD, of the University of Melbourne, and colleagues. Their study was published Jan. 12 in Annals of Internal Medicine.
Research gap
Abnormal knee joint loading has been implicated in the pathogenesis of knee OA. Guidelines recommend that patients wear appropriate footwear, but research has not established which shoes are best.
The 2019 American College of Rheumatology clinical guidelines note that “optimal footwear is likely to be of considerable importance for those with knee and/or hip OA,” but “the available studies do not define the best type of footwear to improve specific outcomes for knee or hip OA.”
Some doctors call for thick, shock-absorbing soles and arch supports, based on expert opinion. On the other hand, studies have found that knee loading is lower with flat flexible shoes, and preliminary evidence has suggested that flat flexible shoes may improve OA symptoms, the investigators said.
To study this question, they enrolled in their trial 164 patients aged 50 years and older who had radiographic medial knee OA. Participants had knee pain on most days of the previous month, tibiofemoral osteophytes, and moderate to severe tibiofemoral OA.
The researchers randomly assigned 82 participants to flat flexible shoes and 82 participants to stable supportive shoes, worn for at least 6 hours a day for 6 months.
In the trial, flat flexible shoes included Merrell Bare Access (men’s and women’s), Vivobarefoot Primus Lite (men’s and women’s), Vivobarefoot Mata Canvas (men’s), Converse Dainty Low (women’s), and Lacoste Marice (men’s).
Stable supportive shoes included ASICS Kayano (men’s and women’s), Merrell Jungle Moc (men’s), Nike Air Max 90 Ultra (women’s), Rockport Edge Hill (men’s), and New Balance 624 (women’s).
After participants were randomly assigned to a group, they chose two different pairs of shoes from their assigned footwear group.
“Participants were not told that the purpose of the study was to compare flat flexible with stable supportive shoes,” the researchers noted. “Instead, they were informed only that the trial was comparing the effects of ‘different shoes’ on knee OA symptoms.”
The primary outcomes were changes in walking pain on a 0-10 scale and physical function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index subscale at 6 months. The researchers also assessed other measures of pain and function, physical activity, and quality of life.
In all, 161 participants reported 6-month primary outcomes. The between-group difference in change in pain favored stable supportive shoes (mean difference, 1.1 units). In the flat flexible shoe group, overall average knee pain while walking decreased from 6.3 at baseline to 5.2 at 6 months. In the stable supportive shoe group, knee pain while walking decreased from 6.1 to 4.
In addition, improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes.
Participants who wore stable supportive shoes also were less likely to report adverse events, compared with those who wore flat flexible shoes (15% vs. 32%). Knee pain, ankle or foot pain, and shin or calf pain were among the adverse events reported.
‘Important work’
“This study suggests that more supportive shoes may help some patients with knee osteoarthritis feel better,” Constance R. Chu, MD, professor of orthopedic surgery at Stanford (Calif.) University, said in an interview. “Shoes, insoles, wedges, and high heels have been shown to change loading of the knee related to knee pain and osteoarthritis ... This is important work toward providing more specific information on the optimum shoes for people with different patterns and types of arthritis to reduce pain and disability from early knee OA.”
The reported changes in pain may be clinically meaningful for many but not all patients, the authors wrote. “Despite biomechanical evidence showing that flat flexible shoes reduce medial knee load compared with stable supportive shoes, our findings show that this does not translate to improved knee osteoarthritis symptoms,” they said. “This may be because relationships between knee loading and symptoms are not as strong as previously thought, or because the small reductions in medial knee load with flat flexible shoes are insufficient to substantively improve pain and function.”
The trial did not include a control group of patients who wore their usual shoes, and it focused on a select subgroup of patients with knee OA, which may limit the study’s generalizability, the authors noted. The study excluded people with lateral joint space narrowing greater than or equal to medial, those with recent or planned knee surgery, and those who were using shoe orthoses or customized shoes.
The study was supported by grants from the National Health and Medical Research Council. Dr. Chu had no relevant disclosures.
according to a randomized trial that included more than 160 patients.
“Contrary to our hypothesis, flat flexible shoes were not superior to stable supportive shoes,” reported Kade L. Paterson, PhD, of the University of Melbourne, and colleagues. Their study was published Jan. 12 in Annals of Internal Medicine.
Research gap
Abnormal knee joint loading has been implicated in the pathogenesis of knee OA. Guidelines recommend that patients wear appropriate footwear, but research has not established which shoes are best.
The 2019 American College of Rheumatology clinical guidelines note that “optimal footwear is likely to be of considerable importance for those with knee and/or hip OA,” but “the available studies do not define the best type of footwear to improve specific outcomes for knee or hip OA.”
Some doctors call for thick, shock-absorbing soles and arch supports, based on expert opinion. On the other hand, studies have found that knee loading is lower with flat flexible shoes, and preliminary evidence has suggested that flat flexible shoes may improve OA symptoms, the investigators said.
To study this question, they enrolled in their trial 164 patients aged 50 years and older who had radiographic medial knee OA. Participants had knee pain on most days of the previous month, tibiofemoral osteophytes, and moderate to severe tibiofemoral OA.
The researchers randomly assigned 82 participants to flat flexible shoes and 82 participants to stable supportive shoes, worn for at least 6 hours a day for 6 months.
In the trial, flat flexible shoes included Merrell Bare Access (men’s and women’s), Vivobarefoot Primus Lite (men’s and women’s), Vivobarefoot Mata Canvas (men’s), Converse Dainty Low (women’s), and Lacoste Marice (men’s).
Stable supportive shoes included ASICS Kayano (men’s and women’s), Merrell Jungle Moc (men’s), Nike Air Max 90 Ultra (women’s), Rockport Edge Hill (men’s), and New Balance 624 (women’s).
After participants were randomly assigned to a group, they chose two different pairs of shoes from their assigned footwear group.
“Participants were not told that the purpose of the study was to compare flat flexible with stable supportive shoes,” the researchers noted. “Instead, they were informed only that the trial was comparing the effects of ‘different shoes’ on knee OA symptoms.”
The primary outcomes were changes in walking pain on a 0-10 scale and physical function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index subscale at 6 months. The researchers also assessed other measures of pain and function, physical activity, and quality of life.
In all, 161 participants reported 6-month primary outcomes. The between-group difference in change in pain favored stable supportive shoes (mean difference, 1.1 units). In the flat flexible shoe group, overall average knee pain while walking decreased from 6.3 at baseline to 5.2 at 6 months. In the stable supportive shoe group, knee pain while walking decreased from 6.1 to 4.
In addition, improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes.
Participants who wore stable supportive shoes also were less likely to report adverse events, compared with those who wore flat flexible shoes (15% vs. 32%). Knee pain, ankle or foot pain, and shin or calf pain were among the adverse events reported.
‘Important work’
“This study suggests that more supportive shoes may help some patients with knee osteoarthritis feel better,” Constance R. Chu, MD, professor of orthopedic surgery at Stanford (Calif.) University, said in an interview. “Shoes, insoles, wedges, and high heels have been shown to change loading of the knee related to knee pain and osteoarthritis ... This is important work toward providing more specific information on the optimum shoes for people with different patterns and types of arthritis to reduce pain and disability from early knee OA.”
The reported changes in pain may be clinically meaningful for many but not all patients, the authors wrote. “Despite biomechanical evidence showing that flat flexible shoes reduce medial knee load compared with stable supportive shoes, our findings show that this does not translate to improved knee osteoarthritis symptoms,” they said. “This may be because relationships between knee loading and symptoms are not as strong as previously thought, or because the small reductions in medial knee load with flat flexible shoes are insufficient to substantively improve pain and function.”
The trial did not include a control group of patients who wore their usual shoes, and it focused on a select subgroup of patients with knee OA, which may limit the study’s generalizability, the authors noted. The study excluded people with lateral joint space narrowing greater than or equal to medial, those with recent or planned knee surgery, and those who were using shoe orthoses or customized shoes.
The study was supported by grants from the National Health and Medical Research Council. Dr. Chu had no relevant disclosures.
according to a randomized trial that included more than 160 patients.
“Contrary to our hypothesis, flat flexible shoes were not superior to stable supportive shoes,” reported Kade L. Paterson, PhD, of the University of Melbourne, and colleagues. Their study was published Jan. 12 in Annals of Internal Medicine.
Research gap
Abnormal knee joint loading has been implicated in the pathogenesis of knee OA. Guidelines recommend that patients wear appropriate footwear, but research has not established which shoes are best.
The 2019 American College of Rheumatology clinical guidelines note that “optimal footwear is likely to be of considerable importance for those with knee and/or hip OA,” but “the available studies do not define the best type of footwear to improve specific outcomes for knee or hip OA.”
Some doctors call for thick, shock-absorbing soles and arch supports, based on expert opinion. On the other hand, studies have found that knee loading is lower with flat flexible shoes, and preliminary evidence has suggested that flat flexible shoes may improve OA symptoms, the investigators said.
To study this question, they enrolled in their trial 164 patients aged 50 years and older who had radiographic medial knee OA. Participants had knee pain on most days of the previous month, tibiofemoral osteophytes, and moderate to severe tibiofemoral OA.
The researchers randomly assigned 82 participants to flat flexible shoes and 82 participants to stable supportive shoes, worn for at least 6 hours a day for 6 months.
In the trial, flat flexible shoes included Merrell Bare Access (men’s and women’s), Vivobarefoot Primus Lite (men’s and women’s), Vivobarefoot Mata Canvas (men’s), Converse Dainty Low (women’s), and Lacoste Marice (men’s).
Stable supportive shoes included ASICS Kayano (men’s and women’s), Merrell Jungle Moc (men’s), Nike Air Max 90 Ultra (women’s), Rockport Edge Hill (men’s), and New Balance 624 (women’s).
After participants were randomly assigned to a group, they chose two different pairs of shoes from their assigned footwear group.
“Participants were not told that the purpose of the study was to compare flat flexible with stable supportive shoes,” the researchers noted. “Instead, they were informed only that the trial was comparing the effects of ‘different shoes’ on knee OA symptoms.”
The primary outcomes were changes in walking pain on a 0-10 scale and physical function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index subscale at 6 months. The researchers also assessed other measures of pain and function, physical activity, and quality of life.
In all, 161 participants reported 6-month primary outcomes. The between-group difference in change in pain favored stable supportive shoes (mean difference, 1.1 units). In the flat flexible shoe group, overall average knee pain while walking decreased from 6.3 at baseline to 5.2 at 6 months. In the stable supportive shoe group, knee pain while walking decreased from 6.1 to 4.
In addition, improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes.
Participants who wore stable supportive shoes also were less likely to report adverse events, compared with those who wore flat flexible shoes (15% vs. 32%). Knee pain, ankle or foot pain, and shin or calf pain were among the adverse events reported.
‘Important work’
“This study suggests that more supportive shoes may help some patients with knee osteoarthritis feel better,” Constance R. Chu, MD, professor of orthopedic surgery at Stanford (Calif.) University, said in an interview. “Shoes, insoles, wedges, and high heels have been shown to change loading of the knee related to knee pain and osteoarthritis ... This is important work toward providing more specific information on the optimum shoes for people with different patterns and types of arthritis to reduce pain and disability from early knee OA.”
The reported changes in pain may be clinically meaningful for many but not all patients, the authors wrote. “Despite biomechanical evidence showing that flat flexible shoes reduce medial knee load compared with stable supportive shoes, our findings show that this does not translate to improved knee osteoarthritis symptoms,” they said. “This may be because relationships between knee loading and symptoms are not as strong as previously thought, or because the small reductions in medial knee load with flat flexible shoes are insufficient to substantively improve pain and function.”
The trial did not include a control group of patients who wore their usual shoes, and it focused on a select subgroup of patients with knee OA, which may limit the study’s generalizability, the authors noted. The study excluded people with lateral joint space narrowing greater than or equal to medial, those with recent or planned knee surgery, and those who were using shoe orthoses or customized shoes.
The study was supported by grants from the National Health and Medical Research Council. Dr. Chu had no relevant disclosures.
FROM ANNALS OF INTERNAL MEDICINE
FDA finalizes guidance for power morcellators in gynecologic surgery
The agency noted that physicians should conduct a thorough preoperative screening and that the devices should only be used for hysterectomies and myomectomies. Clinicians should not use the devices in cases involving uterine malignancy or suspected uterine malignancy.
In addition, clinicians should not use morcellators to remove uterine tissue containing suspected fibroids in women older than 50 years or who are postmenopausal. Nor should the devices be used for women who are “candidates for removal of tissue (en bloc) through the vagina or via a minilaparotomy incision,” the agency said.
The safety communication, which was issued on Dec. 29, 2020, updates previous guidance from February 2020. The updated recommendations are consistent with final labeling guidance for laparoscopic power morcellators, also issued by the FDA on Dec. 29.
Risk of disease spread
Prior evidence suggests that use of uncontained power morcellators in women with malignant uterine tissue can spread disease.
Even among women who do not have malignant uterine tissue, containment is important. The agency noted an association between uncontained power morcellation and the spread of benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis, which could require additional surgeries.
In 2016, the FDA approved the PneumoLiner, a containment system for isolating uterine tissue that is not suspected of containing cancer.
“While unsuspected cancer can occur at any age, the prevalence of unsuspected cancer in women undergoing hysterectomy for fibroids increases with age such that the benefit-risk profile of using [laparoscopic power morcellators] is worse in older women when compared to younger women,” according to the new labeling guidance. “Also, the surgical technique of en bloc tissue removal eliminates the need to perform morcellation, thereby reducing the risk of iatrogenic dissemination and upstaging of an occult sarcoma. A thorough preoperative screening should be conducted; however, it is important to note that no screening procedure that can reliably detect sarcoma preoperatively has been identified.”
“The FDA will continue to review the latest data and scientific literature on laparoscopic power morcellation, including gathering real-world evidence from patients, providers and others, and encouraging innovation to better detect uterine cancer and develop containment systems for gynecologic surgery,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a news release. “The FDA seeks to ensure women and their health care providers are fully informed when considering laparoscopic power morcellators for gynecologic surgeries.”
A version of this article first appeared on Medscape.com.
The agency noted that physicians should conduct a thorough preoperative screening and that the devices should only be used for hysterectomies and myomectomies. Clinicians should not use the devices in cases involving uterine malignancy or suspected uterine malignancy.
In addition, clinicians should not use morcellators to remove uterine tissue containing suspected fibroids in women older than 50 years or who are postmenopausal. Nor should the devices be used for women who are “candidates for removal of tissue (en bloc) through the vagina or via a minilaparotomy incision,” the agency said.
The safety communication, which was issued on Dec. 29, 2020, updates previous guidance from February 2020. The updated recommendations are consistent with final labeling guidance for laparoscopic power morcellators, also issued by the FDA on Dec. 29.
Risk of disease spread
Prior evidence suggests that use of uncontained power morcellators in women with malignant uterine tissue can spread disease.
Even among women who do not have malignant uterine tissue, containment is important. The agency noted an association between uncontained power morcellation and the spread of benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis, which could require additional surgeries.
In 2016, the FDA approved the PneumoLiner, a containment system for isolating uterine tissue that is not suspected of containing cancer.
“While unsuspected cancer can occur at any age, the prevalence of unsuspected cancer in women undergoing hysterectomy for fibroids increases with age such that the benefit-risk profile of using [laparoscopic power morcellators] is worse in older women when compared to younger women,” according to the new labeling guidance. “Also, the surgical technique of en bloc tissue removal eliminates the need to perform morcellation, thereby reducing the risk of iatrogenic dissemination and upstaging of an occult sarcoma. A thorough preoperative screening should be conducted; however, it is important to note that no screening procedure that can reliably detect sarcoma preoperatively has been identified.”
“The FDA will continue to review the latest data and scientific literature on laparoscopic power morcellation, including gathering real-world evidence from patients, providers and others, and encouraging innovation to better detect uterine cancer and develop containment systems for gynecologic surgery,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a news release. “The FDA seeks to ensure women and their health care providers are fully informed when considering laparoscopic power morcellators for gynecologic surgeries.”
A version of this article first appeared on Medscape.com.
The agency noted that physicians should conduct a thorough preoperative screening and that the devices should only be used for hysterectomies and myomectomies. Clinicians should not use the devices in cases involving uterine malignancy or suspected uterine malignancy.
In addition, clinicians should not use morcellators to remove uterine tissue containing suspected fibroids in women older than 50 years or who are postmenopausal. Nor should the devices be used for women who are “candidates for removal of tissue (en bloc) through the vagina or via a minilaparotomy incision,” the agency said.
The safety communication, which was issued on Dec. 29, 2020, updates previous guidance from February 2020. The updated recommendations are consistent with final labeling guidance for laparoscopic power morcellators, also issued by the FDA on Dec. 29.
Risk of disease spread
Prior evidence suggests that use of uncontained power morcellators in women with malignant uterine tissue can spread disease.
Even among women who do not have malignant uterine tissue, containment is important. The agency noted an association between uncontained power morcellation and the spread of benign uterine tissue, such as parasitic myomas and disseminated peritoneal leiomyomatosis, which could require additional surgeries.
In 2016, the FDA approved the PneumoLiner, a containment system for isolating uterine tissue that is not suspected of containing cancer.
“While unsuspected cancer can occur at any age, the prevalence of unsuspected cancer in women undergoing hysterectomy for fibroids increases with age such that the benefit-risk profile of using [laparoscopic power morcellators] is worse in older women when compared to younger women,” according to the new labeling guidance. “Also, the surgical technique of en bloc tissue removal eliminates the need to perform morcellation, thereby reducing the risk of iatrogenic dissemination and upstaging of an occult sarcoma. A thorough preoperative screening should be conducted; however, it is important to note that no screening procedure that can reliably detect sarcoma preoperatively has been identified.”
“The FDA will continue to review the latest data and scientific literature on laparoscopic power morcellation, including gathering real-world evidence from patients, providers and others, and encouraging innovation to better detect uterine cancer and develop containment systems for gynecologic surgery,” said Jeffrey Shuren, MD, JD, director of the FDA’s Center for Devices and Radiological Health, in a news release. “The FDA seeks to ensure women and their health care providers are fully informed when considering laparoscopic power morcellators for gynecologic surgeries.”
A version of this article first appeared on Medscape.com.
Cloth masks provide inferior protection vs. medical masks, suggests evidence review
according to an evidence review published Jan. 11 in Annals of Family Medicine.
Nevertheless, cloth masks may provide some degree of protection, filtration studies indicate. If clinicians use cloth masks, they should take into account the fit, material, and number of layers, the review authors wrote.
And if cloth masks are used as a last resort, such as during shortages of personal protective equipment (PPE), additional measures may help, such as pairing cloth masks with plastic face shields.
“We recommend frequent cloth mask changes to reduce the risk of moisture retention and washing according to hospital laundry standards to decrease the risk of ineffective cleaning,” review author Ariel Kiyomi Daoud, a researcher at the University of Colorado at Denver, Aurora, and colleagues wrote.
The investigators identified and analyzed nine studies related to cloth masks’ ability to prevent respiratory viral infections among health care clinicians. The studies generally were not specific to SARS-CoV-2. They focused on four nonrandomized trials, three laboratory efficacy studies, one single-case experiment, and one randomized controlled trial.
Filtration and fit
“Seven publications addressed the filtration efficacy of commercial cloth masks or materials used to create homemade masks ... in a laboratory setting,” the researchers wrote. These studies found that cloth materials prevent some level of penetration, but generally have “lesser filtration efficiency and greater variability than medical masks” do.
One study found that the materials with the greatest filtration efficacy – vacuum bags and tea towels – had low airflow, which limits their use.
Two studies found that additional layers may increase the viral filtration efficacy of cloth masks.
Several studies that assessed mask fit and airflow found that cloth masks “have worse fit and a greater level of particle leakage, compared to medical masks,” the authors reported. Most studies did not examine cloth masks’ ability to protect wearers from respiratory droplets or contact, which the World Health Organization consider the primary means of SARS-CoV-2 spread, with aerosols playing a smaller role. “Thus, we must interpret these results with caution in the context of COVID-19,” the authors wrote. “For a primary care clinician without access to medical masks, our qualitative synthesis of the literature suggests that it is better to wear a cloth mask than no mask,” as long as other protective measures are considered along with cloth mask use.
Generally consistent guidance
Agencies and researchers have shared similar recommendations about the use of cloth masks in health care settings.
“Health care workers are at the frontline and they need to be protected,” said Abrar Ahmad Chughtai, MBBS, MPH, PhD, an epidemiologist at University of New South Wales, Sydney, in an interview. “Many studies show that respirators are more effective, compared to medical masks, and medical masks are more effective, compared to cloth masks. So ideally, all frontline health care workers should use respirators. If respirators are not available, then medical masks should be used. Cloth masks are not as effective as medical masks and ideally should not be used in health care settings.”
Dr. Chughtai has written about cloth masks for protection against SARS-CoV-2 and was an investigator for a 2015 randomized trial that compared medical masks and cloth masks in health care workers.
In that trial, which was considered in the review, greater rates of influenza-like illness occurred in the cloth mask arm, compared with the medical mask arm.
“Studies show that three or more layers of cloth may reduce the spread of droplets and aerosols from the wearers,” Dr. Chughtai said. “So, cloth masks may be used in community settings to prevent spread of infections from the sick, particularly asymptomatic, people.”
In addition, cloth masks “may be used by health care workers as a last resort, if no other option is available,” he said. In that case, they should have at least three layers, fit to the face, and be washed regularly.
Not considered PPE
According to routine infection prevention and control recommendations for health care personnel from the Centers for Disease Control and Prevention, face masks – often referred to as surgical masks or procedure masks – should be worn by workers “at all times while they are in the healthcare facility, including in break rooms or other spaces where they might encounter coworkers.”
Unlike cloth masks, face masks offer “protection for the wearer against exposure to splashes and sprays of infectious material from others,” as well as source control, the agency says. Health care personnel “should remove their respirator or face mask, perform hand hygiene, and put on their cloth mask when leaving the facility at the end of their shift,” according to the CDC.
“Cloth masks are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or face mask is recommended,” the agency notes.
When respirators or face masks are unavailable, health care personnel “might use cloth masks as a last resort for care of patients with suspected or confirmed diagnosis for which face mask or respirator use is normally recommended,” according to CDC guidance.
In that scenario, cloth masks “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face,” the CDC says.
Limited data for comparisons
A Dec. 29, 2020, update in Annals of Internal Medicine about masks for prevention of respiratory virus infections highlighted two recent studies in the United States that reported on mask use in health care settings. A study of more than 16,000 health care workers and first responders found that those who used an N95 or surgical mask all of the time were less likely to have SARS-CoV-2 antibodies, compared with workers who did not wear masks all the time. The adjusted odds ratio with consistent N95 use was 0.83, and the aOR with consistent surgical mask use was 0.86.
In the second study, which included more than 20,000 asymptomatic health care workers, risk for infection was reduced with any mask use versus no mask use (OR, 0.58). An N95 mask was associated with decreased risk versus a surgical mask (OR, 0.76). The studies had methodological limitations, however, and “evidence for various comparisons about mask use in health care settings and risk for SARS-CoV-2 remains insufficient,” the authors of the update wrote.
The Annals of Family Medicine review authors had no relevant disclosures. Dr. Chughtai has tested filtration of 3M masks and worked with CleanSpace Technology to research fit testing of respirators, and the 2015 randomized trial was funded by an Australian Research Council Linkage Grant with 3M as a partner on the grant. The Dec. 29, 2020, update was of a review that originally was supported by grants from the Agency for Healthcare Research Quality.
SOURCE: Daoud AK et al. Ann Fam Med. 2020 Jan 11. doi: 10.1370/afm.2640.
according to an evidence review published Jan. 11 in Annals of Family Medicine.
Nevertheless, cloth masks may provide some degree of protection, filtration studies indicate. If clinicians use cloth masks, they should take into account the fit, material, and number of layers, the review authors wrote.
And if cloth masks are used as a last resort, such as during shortages of personal protective equipment (PPE), additional measures may help, such as pairing cloth masks with plastic face shields.
“We recommend frequent cloth mask changes to reduce the risk of moisture retention and washing according to hospital laundry standards to decrease the risk of ineffective cleaning,” review author Ariel Kiyomi Daoud, a researcher at the University of Colorado at Denver, Aurora, and colleagues wrote.
The investigators identified and analyzed nine studies related to cloth masks’ ability to prevent respiratory viral infections among health care clinicians. The studies generally were not specific to SARS-CoV-2. They focused on four nonrandomized trials, three laboratory efficacy studies, one single-case experiment, and one randomized controlled trial.
Filtration and fit
“Seven publications addressed the filtration efficacy of commercial cloth masks or materials used to create homemade masks ... in a laboratory setting,” the researchers wrote. These studies found that cloth materials prevent some level of penetration, but generally have “lesser filtration efficiency and greater variability than medical masks” do.
One study found that the materials with the greatest filtration efficacy – vacuum bags and tea towels – had low airflow, which limits their use.
Two studies found that additional layers may increase the viral filtration efficacy of cloth masks.
Several studies that assessed mask fit and airflow found that cloth masks “have worse fit and a greater level of particle leakage, compared to medical masks,” the authors reported. Most studies did not examine cloth masks’ ability to protect wearers from respiratory droplets or contact, which the World Health Organization consider the primary means of SARS-CoV-2 spread, with aerosols playing a smaller role. “Thus, we must interpret these results with caution in the context of COVID-19,” the authors wrote. “For a primary care clinician without access to medical masks, our qualitative synthesis of the literature suggests that it is better to wear a cloth mask than no mask,” as long as other protective measures are considered along with cloth mask use.
Generally consistent guidance
Agencies and researchers have shared similar recommendations about the use of cloth masks in health care settings.
“Health care workers are at the frontline and they need to be protected,” said Abrar Ahmad Chughtai, MBBS, MPH, PhD, an epidemiologist at University of New South Wales, Sydney, in an interview. “Many studies show that respirators are more effective, compared to medical masks, and medical masks are more effective, compared to cloth masks. So ideally, all frontline health care workers should use respirators. If respirators are not available, then medical masks should be used. Cloth masks are not as effective as medical masks and ideally should not be used in health care settings.”
Dr. Chughtai has written about cloth masks for protection against SARS-CoV-2 and was an investigator for a 2015 randomized trial that compared medical masks and cloth masks in health care workers.
In that trial, which was considered in the review, greater rates of influenza-like illness occurred in the cloth mask arm, compared with the medical mask arm.
“Studies show that three or more layers of cloth may reduce the spread of droplets and aerosols from the wearers,” Dr. Chughtai said. “So, cloth masks may be used in community settings to prevent spread of infections from the sick, particularly asymptomatic, people.”
In addition, cloth masks “may be used by health care workers as a last resort, if no other option is available,” he said. In that case, they should have at least three layers, fit to the face, and be washed regularly.
Not considered PPE
According to routine infection prevention and control recommendations for health care personnel from the Centers for Disease Control and Prevention, face masks – often referred to as surgical masks or procedure masks – should be worn by workers “at all times while they are in the healthcare facility, including in break rooms or other spaces where they might encounter coworkers.”
Unlike cloth masks, face masks offer “protection for the wearer against exposure to splashes and sprays of infectious material from others,” as well as source control, the agency says. Health care personnel “should remove their respirator or face mask, perform hand hygiene, and put on their cloth mask when leaving the facility at the end of their shift,” according to the CDC.
“Cloth masks are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or face mask is recommended,” the agency notes.
When respirators or face masks are unavailable, health care personnel “might use cloth masks as a last resort for care of patients with suspected or confirmed diagnosis for which face mask or respirator use is normally recommended,” according to CDC guidance.
In that scenario, cloth masks “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face,” the CDC says.
Limited data for comparisons
A Dec. 29, 2020, update in Annals of Internal Medicine about masks for prevention of respiratory virus infections highlighted two recent studies in the United States that reported on mask use in health care settings. A study of more than 16,000 health care workers and first responders found that those who used an N95 or surgical mask all of the time were less likely to have SARS-CoV-2 antibodies, compared with workers who did not wear masks all the time. The adjusted odds ratio with consistent N95 use was 0.83, and the aOR with consistent surgical mask use was 0.86.
In the second study, which included more than 20,000 asymptomatic health care workers, risk for infection was reduced with any mask use versus no mask use (OR, 0.58). An N95 mask was associated with decreased risk versus a surgical mask (OR, 0.76). The studies had methodological limitations, however, and “evidence for various comparisons about mask use in health care settings and risk for SARS-CoV-2 remains insufficient,” the authors of the update wrote.
The Annals of Family Medicine review authors had no relevant disclosures. Dr. Chughtai has tested filtration of 3M masks and worked with CleanSpace Technology to research fit testing of respirators, and the 2015 randomized trial was funded by an Australian Research Council Linkage Grant with 3M as a partner on the grant. The Dec. 29, 2020, update was of a review that originally was supported by grants from the Agency for Healthcare Research Quality.
SOURCE: Daoud AK et al. Ann Fam Med. 2020 Jan 11. doi: 10.1370/afm.2640.
according to an evidence review published Jan. 11 in Annals of Family Medicine.
Nevertheless, cloth masks may provide some degree of protection, filtration studies indicate. If clinicians use cloth masks, they should take into account the fit, material, and number of layers, the review authors wrote.
And if cloth masks are used as a last resort, such as during shortages of personal protective equipment (PPE), additional measures may help, such as pairing cloth masks with plastic face shields.
“We recommend frequent cloth mask changes to reduce the risk of moisture retention and washing according to hospital laundry standards to decrease the risk of ineffective cleaning,” review author Ariel Kiyomi Daoud, a researcher at the University of Colorado at Denver, Aurora, and colleagues wrote.
The investigators identified and analyzed nine studies related to cloth masks’ ability to prevent respiratory viral infections among health care clinicians. The studies generally were not specific to SARS-CoV-2. They focused on four nonrandomized trials, three laboratory efficacy studies, one single-case experiment, and one randomized controlled trial.
Filtration and fit
“Seven publications addressed the filtration efficacy of commercial cloth masks or materials used to create homemade masks ... in a laboratory setting,” the researchers wrote. These studies found that cloth materials prevent some level of penetration, but generally have “lesser filtration efficiency and greater variability than medical masks” do.
One study found that the materials with the greatest filtration efficacy – vacuum bags and tea towels – had low airflow, which limits their use.
Two studies found that additional layers may increase the viral filtration efficacy of cloth masks.
Several studies that assessed mask fit and airflow found that cloth masks “have worse fit and a greater level of particle leakage, compared to medical masks,” the authors reported. Most studies did not examine cloth masks’ ability to protect wearers from respiratory droplets or contact, which the World Health Organization consider the primary means of SARS-CoV-2 spread, with aerosols playing a smaller role. “Thus, we must interpret these results with caution in the context of COVID-19,” the authors wrote. “For a primary care clinician without access to medical masks, our qualitative synthesis of the literature suggests that it is better to wear a cloth mask than no mask,” as long as other protective measures are considered along with cloth mask use.
Generally consistent guidance
Agencies and researchers have shared similar recommendations about the use of cloth masks in health care settings.
“Health care workers are at the frontline and they need to be protected,” said Abrar Ahmad Chughtai, MBBS, MPH, PhD, an epidemiologist at University of New South Wales, Sydney, in an interview. “Many studies show that respirators are more effective, compared to medical masks, and medical masks are more effective, compared to cloth masks. So ideally, all frontline health care workers should use respirators. If respirators are not available, then medical masks should be used. Cloth masks are not as effective as medical masks and ideally should not be used in health care settings.”
Dr. Chughtai has written about cloth masks for protection against SARS-CoV-2 and was an investigator for a 2015 randomized trial that compared medical masks and cloth masks in health care workers.
In that trial, which was considered in the review, greater rates of influenza-like illness occurred in the cloth mask arm, compared with the medical mask arm.
“Studies show that three or more layers of cloth may reduce the spread of droplets and aerosols from the wearers,” Dr. Chughtai said. “So, cloth masks may be used in community settings to prevent spread of infections from the sick, particularly asymptomatic, people.”
In addition, cloth masks “may be used by health care workers as a last resort, if no other option is available,” he said. In that case, they should have at least three layers, fit to the face, and be washed regularly.
Not considered PPE
According to routine infection prevention and control recommendations for health care personnel from the Centers for Disease Control and Prevention, face masks – often referred to as surgical masks or procedure masks – should be worn by workers “at all times while they are in the healthcare facility, including in break rooms or other spaces where they might encounter coworkers.”
Unlike cloth masks, face masks offer “protection for the wearer against exposure to splashes and sprays of infectious material from others,” as well as source control, the agency says. Health care personnel “should remove their respirator or face mask, perform hand hygiene, and put on their cloth mask when leaving the facility at the end of their shift,” according to the CDC.
“Cloth masks are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or face mask is recommended,” the agency notes.
When respirators or face masks are unavailable, health care personnel “might use cloth masks as a last resort for care of patients with suspected or confirmed diagnosis for which face mask or respirator use is normally recommended,” according to CDC guidance.
In that scenario, cloth masks “should ideally be used in combination with a face shield that covers the entire front (that extends to the chin or below) and sides of the face,” the CDC says.
Limited data for comparisons
A Dec. 29, 2020, update in Annals of Internal Medicine about masks for prevention of respiratory virus infections highlighted two recent studies in the United States that reported on mask use in health care settings. A study of more than 16,000 health care workers and first responders found that those who used an N95 or surgical mask all of the time were less likely to have SARS-CoV-2 antibodies, compared with workers who did not wear masks all the time. The adjusted odds ratio with consistent N95 use was 0.83, and the aOR with consistent surgical mask use was 0.86.
In the second study, which included more than 20,000 asymptomatic health care workers, risk for infection was reduced with any mask use versus no mask use (OR, 0.58). An N95 mask was associated with decreased risk versus a surgical mask (OR, 0.76). The studies had methodological limitations, however, and “evidence for various comparisons about mask use in health care settings and risk for SARS-CoV-2 remains insufficient,” the authors of the update wrote.
The Annals of Family Medicine review authors had no relevant disclosures. Dr. Chughtai has tested filtration of 3M masks and worked with CleanSpace Technology to research fit testing of respirators, and the 2015 randomized trial was funded by an Australian Research Council Linkage Grant with 3M as a partner on the grant. The Dec. 29, 2020, update was of a review that originally was supported by grants from the Agency for Healthcare Research Quality.
SOURCE: Daoud AK et al. Ann Fam Med. 2020 Jan 11. doi: 10.1370/afm.2640.
FROM ANNALS OF FAMILY MEDICINE
In utero SARS-CoV-2 transmission unlikely, but neonates may be unprotected
No maternal viremia, placental infection, or vertical transmission of SARS-CoV-2 occurred during a biorepository study that included 64 women with SARS-CoV-2 infection, researchers reported in JAMA Network Open.
But SARS-CoV-2 antibodies transferred relatively inefficiently across the placenta in the third trimester, which suggests that neonates whose mothers had COVID-19 during pregnancy still may be vulnerable to the virus, the investigators said. Antibodies may transfer more efficiently with second-trimester infections, data from another study indicate.
“These findings suggest that, although low rates of maternal viremia and patterns of placental SARS-CoV-2 receptor distribution may underlie the rarity of vertical transmission, reduced transplacental transfer of anti–SARS-CoV-2 antibodies may leave neonates at risk for infection,” wrote study author Andrea G. Edlow, MD, MSc, and colleagues. Dr. Edlow is an assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School and a maternal-fetal medicine specialist at Massachusetts General Hospital, both in Boston.
In another study published in Cell, the research team found that, unlike with third trimester infections, SARS-CoV-2 antibodies transferred efficiently after infection in the second trimester. “Understanding how de novo antibody transfer varies by trimester may point to critical windows in pregnancy that may be most desirable for induction of antibodies through vaccination to optimize protection for both the mother and her infant,” they wrote.
It is unclear whether antibodies that are elicited by recently authorized vaccines will transfer differently than those elicited by natural infection.
Reassurance, questions, and concerns
“Although it is not known whether the inefficient transplacental transfer of antibodies ... will also extend to antibodies elicited by future SARS-CoV-2 vaccines, it underscores the susceptibility of infants,” said Denise J. Jamieson, MD, MPH, of Emory University, Atlanta, and Sonja A. Rasmussen, MD, MS, of the University of Florida, Gainesville, in an editorial accompanying the JAMA Network Open study.
And while the lack of vertical disease transmission in this study is reassuring, more research is needed, according to the director of a federal institute that helped fund the research.
“This study provides some reassurance that SARS-CoV-2 infections during the third trimester are unlikely to pass through the placenta to the fetus, but more research needs to be done to confirm this finding,” said Diana W. Bianchi, MD, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, in a news release.
The study authors theorize that the low incidence of maternal viremia and nonoverlapping expression of SARS-CoV-2 receptors ACE2 and TMPRSS2 in the placenta may protect against placental infection and vertical transmission.
Testing at 3 centers
To quantify SARS-CoV-2 viral load in maternal and neonatal biofluids and the transplacental passage of anti–SARS-CoV-2 antibodies, Dr. Edlow and collaborators enrolled 127 pregnant women at three tertiary care centers in Boston between April 2 and June 13, 2020. Follow-up occurred through July 10. Researchers tested neonates born to women with SARS-CoV-2 infection by nasopharyngeal swab at age 24 hours.
Of 64 women with SARS-CoV-2 infection, 36% were asymptomatic, 34% had mild disease, 11% had moderate disease, 16% had severe disease, and 3% had critical disease. Viral load analyses did not detect viremia in maternal or cord blood, and there was no evidence of vertical transmission.
Transfer of anti–SARS-CoV-2 antibodies was significantly lower than transfer of anti-influenza antibodies The average cord-to-maternal antibody ratio was 0.72 for anti–receptor binding domain IgG and 0.74 for antinucleocapsid, whereas the ratio for anti-influenza antibodies was 1.44. The expected cord-to-maternal antibody ratio is approximately 1.5 for pathogens such as pertussis, influenza, and measles, the authors noted.
Among participants who tested positive for SARS-CoV-2, 35-week intrauterine fetal demise occurred in an asymptomatic woman, and 22-week neonatal demise secondary to extreme prematurity in the setting of abruption and preterm labor occurred in a symptomatic patient.
Maternal disease severity was significantly associated with detectable respiratory viral load. In addition, disease severity was positively correlated with serum concentration of C-reactive protein and ALT, and negatively correlated with white blood cell count.
In the Cell study that further examined antibody transfer, the investigators focused on maternal and cord blood plasma samples from 22 mother-cord dyads with SARS-CoV-2 infection during pregnancy and 34 uninfected mother-neonate dyads, as well as a second trimester cohort of 29 mother-neonate dyads and a third trimester validation cohort of 28 mother-neonate dyads.
Protecting infants
The results support “previous studies that have found that, while intrauterine transmission is possible, it is not common,” Dr. Jamieson and Dr. Rasmussen noted. “Most viral infections can be transmitted transplacentally; however, why some viruses are transmitted relatively easily across the placenta (e.g., HIV, Zika, herpes simplex virus), while others, such as influenza, are transmitted rarely is not well understood.”
Data indicate that infants are at higher risk of severe COVID-19, compared with older children. Nonetheless, research suggests that strict hygiene measures can protect infants born to mothers with SARS-CoV-2 infection, they added.
The research was supported by the National Institutes of Health; the Cystic Fibrosis Foundation; a gift from Mark, Lisa, and Enid Schwartz; and by the Massachusetts General Hospital department of pathology Vickery-Colvin Award and other nonprofit groups. Dr. Edlow, Dr. Jamieson, and Dr. Rasmussen had no conflict of interest disclosures.
The coauthors of both studies disclosed ties to pharmaceutical companies, grants from foundations and government agencies, a patent for a SARS-CoV-2 vaccine, and author royalties from publishers.
No maternal viremia, placental infection, or vertical transmission of SARS-CoV-2 occurred during a biorepository study that included 64 women with SARS-CoV-2 infection, researchers reported in JAMA Network Open.
But SARS-CoV-2 antibodies transferred relatively inefficiently across the placenta in the third trimester, which suggests that neonates whose mothers had COVID-19 during pregnancy still may be vulnerable to the virus, the investigators said. Antibodies may transfer more efficiently with second-trimester infections, data from another study indicate.
“These findings suggest that, although low rates of maternal viremia and patterns of placental SARS-CoV-2 receptor distribution may underlie the rarity of vertical transmission, reduced transplacental transfer of anti–SARS-CoV-2 antibodies may leave neonates at risk for infection,” wrote study author Andrea G. Edlow, MD, MSc, and colleagues. Dr. Edlow is an assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School and a maternal-fetal medicine specialist at Massachusetts General Hospital, both in Boston.
In another study published in Cell, the research team found that, unlike with third trimester infections, SARS-CoV-2 antibodies transferred efficiently after infection in the second trimester. “Understanding how de novo antibody transfer varies by trimester may point to critical windows in pregnancy that may be most desirable for induction of antibodies through vaccination to optimize protection for both the mother and her infant,” they wrote.
It is unclear whether antibodies that are elicited by recently authorized vaccines will transfer differently than those elicited by natural infection.
Reassurance, questions, and concerns
“Although it is not known whether the inefficient transplacental transfer of antibodies ... will also extend to antibodies elicited by future SARS-CoV-2 vaccines, it underscores the susceptibility of infants,” said Denise J. Jamieson, MD, MPH, of Emory University, Atlanta, and Sonja A. Rasmussen, MD, MS, of the University of Florida, Gainesville, in an editorial accompanying the JAMA Network Open study.
And while the lack of vertical disease transmission in this study is reassuring, more research is needed, according to the director of a federal institute that helped fund the research.
“This study provides some reassurance that SARS-CoV-2 infections during the third trimester are unlikely to pass through the placenta to the fetus, but more research needs to be done to confirm this finding,” said Diana W. Bianchi, MD, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, in a news release.
The study authors theorize that the low incidence of maternal viremia and nonoverlapping expression of SARS-CoV-2 receptors ACE2 and TMPRSS2 in the placenta may protect against placental infection and vertical transmission.
Testing at 3 centers
To quantify SARS-CoV-2 viral load in maternal and neonatal biofluids and the transplacental passage of anti–SARS-CoV-2 antibodies, Dr. Edlow and collaborators enrolled 127 pregnant women at three tertiary care centers in Boston between April 2 and June 13, 2020. Follow-up occurred through July 10. Researchers tested neonates born to women with SARS-CoV-2 infection by nasopharyngeal swab at age 24 hours.
Of 64 women with SARS-CoV-2 infection, 36% were asymptomatic, 34% had mild disease, 11% had moderate disease, 16% had severe disease, and 3% had critical disease. Viral load analyses did not detect viremia in maternal or cord blood, and there was no evidence of vertical transmission.
Transfer of anti–SARS-CoV-2 antibodies was significantly lower than transfer of anti-influenza antibodies The average cord-to-maternal antibody ratio was 0.72 for anti–receptor binding domain IgG and 0.74 for antinucleocapsid, whereas the ratio for anti-influenza antibodies was 1.44. The expected cord-to-maternal antibody ratio is approximately 1.5 for pathogens such as pertussis, influenza, and measles, the authors noted.
Among participants who tested positive for SARS-CoV-2, 35-week intrauterine fetal demise occurred in an asymptomatic woman, and 22-week neonatal demise secondary to extreme prematurity in the setting of abruption and preterm labor occurred in a symptomatic patient.
Maternal disease severity was significantly associated with detectable respiratory viral load. In addition, disease severity was positively correlated with serum concentration of C-reactive protein and ALT, and negatively correlated with white blood cell count.
In the Cell study that further examined antibody transfer, the investigators focused on maternal and cord blood plasma samples from 22 mother-cord dyads with SARS-CoV-2 infection during pregnancy and 34 uninfected mother-neonate dyads, as well as a second trimester cohort of 29 mother-neonate dyads and a third trimester validation cohort of 28 mother-neonate dyads.
Protecting infants
The results support “previous studies that have found that, while intrauterine transmission is possible, it is not common,” Dr. Jamieson and Dr. Rasmussen noted. “Most viral infections can be transmitted transplacentally; however, why some viruses are transmitted relatively easily across the placenta (e.g., HIV, Zika, herpes simplex virus), while others, such as influenza, are transmitted rarely is not well understood.”
Data indicate that infants are at higher risk of severe COVID-19, compared with older children. Nonetheless, research suggests that strict hygiene measures can protect infants born to mothers with SARS-CoV-2 infection, they added.
The research was supported by the National Institutes of Health; the Cystic Fibrosis Foundation; a gift from Mark, Lisa, and Enid Schwartz; and by the Massachusetts General Hospital department of pathology Vickery-Colvin Award and other nonprofit groups. Dr. Edlow, Dr. Jamieson, and Dr. Rasmussen had no conflict of interest disclosures.
The coauthors of both studies disclosed ties to pharmaceutical companies, grants from foundations and government agencies, a patent for a SARS-CoV-2 vaccine, and author royalties from publishers.
No maternal viremia, placental infection, or vertical transmission of SARS-CoV-2 occurred during a biorepository study that included 64 women with SARS-CoV-2 infection, researchers reported in JAMA Network Open.
But SARS-CoV-2 antibodies transferred relatively inefficiently across the placenta in the third trimester, which suggests that neonates whose mothers had COVID-19 during pregnancy still may be vulnerable to the virus, the investigators said. Antibodies may transfer more efficiently with second-trimester infections, data from another study indicate.
“These findings suggest that, although low rates of maternal viremia and patterns of placental SARS-CoV-2 receptor distribution may underlie the rarity of vertical transmission, reduced transplacental transfer of anti–SARS-CoV-2 antibodies may leave neonates at risk for infection,” wrote study author Andrea G. Edlow, MD, MSc, and colleagues. Dr. Edlow is an assistant professor of obstetrics, gynecology, and reproductive biology at Harvard Medical School and a maternal-fetal medicine specialist at Massachusetts General Hospital, both in Boston.
In another study published in Cell, the research team found that, unlike with third trimester infections, SARS-CoV-2 antibodies transferred efficiently after infection in the second trimester. “Understanding how de novo antibody transfer varies by trimester may point to critical windows in pregnancy that may be most desirable for induction of antibodies through vaccination to optimize protection for both the mother and her infant,” they wrote.
It is unclear whether antibodies that are elicited by recently authorized vaccines will transfer differently than those elicited by natural infection.
Reassurance, questions, and concerns
“Although it is not known whether the inefficient transplacental transfer of antibodies ... will also extend to antibodies elicited by future SARS-CoV-2 vaccines, it underscores the susceptibility of infants,” said Denise J. Jamieson, MD, MPH, of Emory University, Atlanta, and Sonja A. Rasmussen, MD, MS, of the University of Florida, Gainesville, in an editorial accompanying the JAMA Network Open study.
And while the lack of vertical disease transmission in this study is reassuring, more research is needed, according to the director of a federal institute that helped fund the research.
“This study provides some reassurance that SARS-CoV-2 infections during the third trimester are unlikely to pass through the placenta to the fetus, but more research needs to be done to confirm this finding,” said Diana W. Bianchi, MD, director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, in a news release.
The study authors theorize that the low incidence of maternal viremia and nonoverlapping expression of SARS-CoV-2 receptors ACE2 and TMPRSS2 in the placenta may protect against placental infection and vertical transmission.
Testing at 3 centers
To quantify SARS-CoV-2 viral load in maternal and neonatal biofluids and the transplacental passage of anti–SARS-CoV-2 antibodies, Dr. Edlow and collaborators enrolled 127 pregnant women at three tertiary care centers in Boston between April 2 and June 13, 2020. Follow-up occurred through July 10. Researchers tested neonates born to women with SARS-CoV-2 infection by nasopharyngeal swab at age 24 hours.
Of 64 women with SARS-CoV-2 infection, 36% were asymptomatic, 34% had mild disease, 11% had moderate disease, 16% had severe disease, and 3% had critical disease. Viral load analyses did not detect viremia in maternal or cord blood, and there was no evidence of vertical transmission.
Transfer of anti–SARS-CoV-2 antibodies was significantly lower than transfer of anti-influenza antibodies The average cord-to-maternal antibody ratio was 0.72 for anti–receptor binding domain IgG and 0.74 for antinucleocapsid, whereas the ratio for anti-influenza antibodies was 1.44. The expected cord-to-maternal antibody ratio is approximately 1.5 for pathogens such as pertussis, influenza, and measles, the authors noted.
Among participants who tested positive for SARS-CoV-2, 35-week intrauterine fetal demise occurred in an asymptomatic woman, and 22-week neonatal demise secondary to extreme prematurity in the setting of abruption and preterm labor occurred in a symptomatic patient.
Maternal disease severity was significantly associated with detectable respiratory viral load. In addition, disease severity was positively correlated with serum concentration of C-reactive protein and ALT, and negatively correlated with white blood cell count.
In the Cell study that further examined antibody transfer, the investigators focused on maternal and cord blood plasma samples from 22 mother-cord dyads with SARS-CoV-2 infection during pregnancy and 34 uninfected mother-neonate dyads, as well as a second trimester cohort of 29 mother-neonate dyads and a third trimester validation cohort of 28 mother-neonate dyads.
Protecting infants
The results support “previous studies that have found that, while intrauterine transmission is possible, it is not common,” Dr. Jamieson and Dr. Rasmussen noted. “Most viral infections can be transmitted transplacentally; however, why some viruses are transmitted relatively easily across the placenta (e.g., HIV, Zika, herpes simplex virus), while others, such as influenza, are transmitted rarely is not well understood.”
Data indicate that infants are at higher risk of severe COVID-19, compared with older children. Nonetheless, research suggests that strict hygiene measures can protect infants born to mothers with SARS-CoV-2 infection, they added.
The research was supported by the National Institutes of Health; the Cystic Fibrosis Foundation; a gift from Mark, Lisa, and Enid Schwartz; and by the Massachusetts General Hospital department of pathology Vickery-Colvin Award and other nonprofit groups. Dr. Edlow, Dr. Jamieson, and Dr. Rasmussen had no conflict of interest disclosures.
The coauthors of both studies disclosed ties to pharmaceutical companies, grants from foundations and government agencies, a patent for a SARS-CoV-2 vaccine, and author royalties from publishers.
New dietary guidelines omit recommended cuts to sugar, alcohol intake
Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.
The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.
The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions:
- Follow a healthy dietary pattern at every life stage.
- Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
- Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
- Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.
The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
Proposed cutoffs rejected
The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.
It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.
The agencies published a document explaining why they omitted the advisory committee›s conclusions.
The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.
In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.
“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
Guidance for infants and toddlers
The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise.
At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk.
The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.
Dr. Elkind highlighted the significance of these additions.
“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
For all ages
From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.
According to the guidelines, core elements of a healthy diet include:
- Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
- Fruits (especially whole fruit).
- Grains, at least half of which are whole grain.
- Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
- Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
- Oils, including vegetable oils and oils in food, such as seafood and nuts.
The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.
Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.
“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”
An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.
The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.
A version of this article first appeared on Medscape.com.
Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.
The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.
The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions:
- Follow a healthy dietary pattern at every life stage.
- Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
- Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
- Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.
The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
Proposed cutoffs rejected
The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.
It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.
The agencies published a document explaining why they omitted the advisory committee›s conclusions.
The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.
In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.
“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
Guidance for infants and toddlers
The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise.
At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk.
The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.
Dr. Elkind highlighted the significance of these additions.
“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
For all ages
From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.
According to the guidelines, core elements of a healthy diet include:
- Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
- Fruits (especially whole fruit).
- Grains, at least half of which are whole grain.
- Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
- Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
- Oils, including vegetable oils and oils in food, such as seafood and nuts.
The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.
Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.
“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”
An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.
The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.
A version of this article first appeared on Medscape.com.
Although the new guidelines were informed by an advisory committee’s scientific report, officials omitted certain recommendations that would have reduced allowances for added sugars and alcohol intake.
The 2020-2025 Dietary Guidelines for Americans “carried forward the committee’s emphasis on limiting these dietary components, but did not include changes to quantitative recommendations, as there was not a preponderance of evidence in the material the committee reviewed to support specific changes, as required by law,” the agencies said in a news release.
The guidelines encourage Americans to “Make Every Bite Count” through four overarching suggestions:
- Follow a healthy dietary pattern at every life stage.
- Customize nutrient-dense food and beverage choices to reflect preferences, cultural traditions, and budgets.
- Focus on meeting dietary needs from five food groups – vegetables, fruits, grains, dairy and fortified soy alternatives, and proteins – and stay within calorie limits.
- Limit foods and beverages that are higher in added sugars, saturated fat, and sodium, and limit alcoholic beverages.
The guidance “can help all Americans lead healthier lives by making every bite count,” Secretary of Agriculture Sonny Perdue said.
Proposed cutoffs rejected
The guidelines omit a recommendation from the advisory committee’s scientific report to reduce intake of added sugars from less than 10% of calories to less than 6% of calories.
It also omits a recommendation that men and women who drink alcohol limit themselves to one drink per day. It maintains guidance from the 2015-2020 edition that allows two drinks per day for men.
The agencies published a document explaining why they omitted the advisory committee›s conclusions.
The American Heart Association in July had praised the suggestion to reduce added sugars. The proposed change would have helped “steer the public toward a more heart-healthy path in their daily diets,” Mitchell S.V. Elkind, MD, president of the AHA, said at the time. The association would “strongly oppose any efforts to weaken these recommendations,” he added.
In its response to the new guidelines, Dr. Elkind praised the emphasis on a healthy diet “at every life stage” but called out a missed opportunity.
“We are disappointed that USDA and HHS did not accept all of the Dietary Guidelines Advisory Committee’s science-based recommendations in the final guidelines for 2020, including the recommendation to lower added sugars consumption to less than 6% of calories,” he said in a prepared statement.
Guidance for infants and toddlers
The guidelines advise that for about the first 6 months of life, infants should exclusively receive breast milk. Infants should continue to receive breast milk through at least the first year of life, and longer if desired. Infants should be fed iron-fortified infant formula during the first year of life when breast milk is unavailable, and infants should receive supplemental vitamin D soon after birth, the guidelines advise.
At about 6 months, infants should be introduced to a variety of nutrient-dense complementary foods, including potentially allergenic foods. Infants should eat foods that are rich in iron and zinc, particularly if they are fed breast milk.
The guidelines also include dietary and caloric advice for pregnant and lactating women with daily or weekly amounts of food from different groups and subgroups.
Dr. Elkind highlighted the significance of these additions.
“We are pleased that for the first time, the guidelines provide recommendations for pregnant and breastfeeding women as well as infants and toddlers, underscoring the importance of maternal health and proper nutrition across the lifespan,” he said.
For all ages
From 12 months through older adulthood, people should follow a healthy dietary pattern to meet nutrient needs, help achieve a healthy body weight, and reduce the risk of chronic disease.
According to the guidelines, core elements of a healthy diet include:
- Vegetables of all types (dark green; red and orange; beans, peas, and lentils; starchy; and other types).
- Fruits (especially whole fruit).
- Grains, at least half of which are whole grain.
- Dairy, including fat-free or low-fat milk, yogurt, and cheese, and lactose-free versions; and fortified soy beverages and yogurt as alternatives.
- Protein foods, including lean meats, poultry, and eggs; seafood; beans, peas, and lentils; and nuts, seeds, and soy products.
- Oils, including vegetable oils and oils in food, such as seafood and nuts.
The guidelines spell out limits to added sugars, sodium, saturated fat, and alcohol. The recommendation to limit added sugars to less than 10% of calories per day starts at age 2 years. Before age 2, foods and beverages with added sugars should be avoided.
Saturated fat should be limited to less than 10% of calories per day starting at age 2. And sodium intake should be limited to 2,300 mg/day for those age 14 and older, but just 1,200 mg/day for toddlers, 1,500 mg/day for children aged 4-8, and 1,800 mg/day for children 9-13.
“Adults of legal drinking age can choose not to drink or to drink in moderation by limiting intake to 2 drinks or less in a day for men and 1 drink or less in a day for women, when alcohol is consumed,” the agencies said. “Drinking less is better for health than drinking more. There are some adults who should not drink alcohol, such as women who are pregnant.”
An appendix includes estimated calorie needs based on a person’s age, sex, height, weight, and level of physical activity. A need to lose, maintain, or gain weight are among the factors that influence how many calories should be consumed, the guidelines note.
The guidelines are designed for use by health care professionals and policymakers. The USDA has launched a new MyPlate website to help consumers incorporate the dietary guidance.
A version of this article first appeared on Medscape.com.
Does daily inhaler monitoring improve asthma outcomes in children?
Among children with moderate or severe persistent asthma, a randomized trial suggests.
But the intervention also may lead to more ED visits and increased hospitalization rates.
“We improved asthma symptom control but did not reduce health care use,” Ruchi S. Gupta, MD, MPH, and colleagues, wrote in a study published in Pediatrics.
The monitoring system alerted clinicians when a patient used a short-acting beta-agonist more than four times in a day. It could be that the “alerts enabled providers to detect asthma exacerbation virtually and refer for clinically appropriate care that included directing children to the ED,” the authors suggested. It also is possible that the intervention led caregivers to be more vigilant about symptoms and more empowered to seek care.
Adherence to preventive regimens
Many patients with asthma need to use preventive medications such as daily inhaled corticosteroids to control symptoms. Researchers have developed sensor-based inhaler monitoring interventions to improve treatment adherence, but the effectiveness of these interventions in improving asthma outcomes in urban and minority populations is unclear.
To assess the effectiveness of a clinically integrated, sensor-based inhaler monitoring intervention on improving asthma symptom control and related outcomes in children, Dr. Gupta, of Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted a randomized, unblinded study, known as the Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial. They included 252 children: 127 in the control group and 125 in the intervention group.
Patients in the intervention group received Propeller Health’s Food and Drug Administration–cleared inhaler sensors for inhaled corticosteroids and short-acting beta-agonists. Caregivers could use a mobile application and clinicians could use a Web portal to track patients’ medication use. The app featured personalized insights, educational content, encouragement, surveys, and care team services.
Researchers recruited caregivers and children from five Chicago clinics for the study, which was conducted between 2016 and 2018. They included children aged 4-17 years who had a prescription for daily inhaled corticosteroids for at least 1 year before enrollment. In addition, participants had at least 1 exacerbation requiring oral corticosteroids in the previous year. They excluded children with other respiratory conditions. They also excluded participants who did not speak English because the app was available only in English.
“Sensors monitored inhaled medication use, capturing the date, time, and number of uses, and transmitted this information via Bluetooth to a paired smartphone and the provider portal in real-time,” the authors said.
Clinicians were alerted to call participants if a patient missed inhaled corticosteroid doses for 4 continuous days or used more than 4 short-acting beta-agonist doses per day. Clinicians could help guide asthma management, schedule an appointment, refill medications, and address technical difficulties with the sensors.
The intervention and control groups had similar baseline characteristics. About one-third of the patients were female, and the mean age was 9.3 years. In the control group, 28% identified as Hispanic, and 33% identified as non-Hispanic Black. In the intervention group, 40% identified as Hispanic, and 23% identified as non-Hispanic Black. About 59% reported Medicaid insurance. The intervention and control arms completed electronic surveys at 1, 3, 6, 9, and 12 months.
Average Asthma Control Test score increased from 19 to 22 in the intervention group, compared with an increase from 19 to 20 in the control group. Adjusted rates of emergency department visits and hospitalizations were greater in the intervention group (incidence rate ratios, 2.2 and 3.4, respectively). A measure of caregiver quality of life was greater in the intervention group, although the difference was not significant.
During the trial, more caregivers in the intervention group reported asthma attacks for which steroids were prescribed by a medical office (73% vs. 35%).
Some participants had to manually enter the number of daily puffs into the app because their inhalers were incompatible with the sensors. In addition, some data were missing because of incomplete or missing survey responses and sensor failure over time. “The number of intervention participants with actively transmitting sensors decreased from 102 at baseline to 56 at 12 months,” Dr. Gupta and associates noted.
Important area of research
“One interesting finding of this study is the increase in health care use in the intervention group to nearly twice as many emergency department (ED) visits and three times as many hospitalizations as the control group over 12 months,” Rachelle R. Ramsey, PhD, and Theresa W. Guilbert, MD, MS, of the University of Cincinnati, wrote in a related commentary. “Although it is plausible that, as the authors suggest, greater asthma knowledge and monitoring may have led to increased vigilance of asthma symptoms, it seems that this would have only led to an increase in ED visits but not hospitalizations.”
The mixture of objective electronic monitoring and subjective self-reported adherence may complicate interpretation of the results, they added.
“Overall, this article underscores the feasibility and importance of sensor-based electronic monitoring of adherence in pediatric asthma and encourages future research in this area,” Dr. Ramsey and Dr. Guilbert said.
The trial was supported by the UnitedHealth Group. Dr. Gupta has received grants from the National Institutes of Health, Rho, and other organizations, and has served as a medical consultant and adviser for a variety of companies. Dr. Ramsey is supported by the NIH. Dr. Guilbert reported fees from the American Board of Pediatrics, the Pediatric Pulmonary Subboard, and some pharmaceutical companies, plus grants from the NIH, grants and personal fees from Sanofi, Regeneron, and AstraZeneca, and royalties from UpToDate.
SOURCE: Gupta RS et al. Pediatrics. 2020 Dec 22. doi: 10.1542/peds.2020-1330.
Among children with moderate or severe persistent asthma, a randomized trial suggests.
But the intervention also may lead to more ED visits and increased hospitalization rates.
“We improved asthma symptom control but did not reduce health care use,” Ruchi S. Gupta, MD, MPH, and colleagues, wrote in a study published in Pediatrics.
The monitoring system alerted clinicians when a patient used a short-acting beta-agonist more than four times in a day. It could be that the “alerts enabled providers to detect asthma exacerbation virtually and refer for clinically appropriate care that included directing children to the ED,” the authors suggested. It also is possible that the intervention led caregivers to be more vigilant about symptoms and more empowered to seek care.
Adherence to preventive regimens
Many patients with asthma need to use preventive medications such as daily inhaled corticosteroids to control symptoms. Researchers have developed sensor-based inhaler monitoring interventions to improve treatment adherence, but the effectiveness of these interventions in improving asthma outcomes in urban and minority populations is unclear.
To assess the effectiveness of a clinically integrated, sensor-based inhaler monitoring intervention on improving asthma symptom control and related outcomes in children, Dr. Gupta, of Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted a randomized, unblinded study, known as the Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial. They included 252 children: 127 in the control group and 125 in the intervention group.
Patients in the intervention group received Propeller Health’s Food and Drug Administration–cleared inhaler sensors for inhaled corticosteroids and short-acting beta-agonists. Caregivers could use a mobile application and clinicians could use a Web portal to track patients’ medication use. The app featured personalized insights, educational content, encouragement, surveys, and care team services.
Researchers recruited caregivers and children from five Chicago clinics for the study, which was conducted between 2016 and 2018. They included children aged 4-17 years who had a prescription for daily inhaled corticosteroids for at least 1 year before enrollment. In addition, participants had at least 1 exacerbation requiring oral corticosteroids in the previous year. They excluded children with other respiratory conditions. They also excluded participants who did not speak English because the app was available only in English.
“Sensors monitored inhaled medication use, capturing the date, time, and number of uses, and transmitted this information via Bluetooth to a paired smartphone and the provider portal in real-time,” the authors said.
Clinicians were alerted to call participants if a patient missed inhaled corticosteroid doses for 4 continuous days or used more than 4 short-acting beta-agonist doses per day. Clinicians could help guide asthma management, schedule an appointment, refill medications, and address technical difficulties with the sensors.
The intervention and control groups had similar baseline characteristics. About one-third of the patients were female, and the mean age was 9.3 years. In the control group, 28% identified as Hispanic, and 33% identified as non-Hispanic Black. In the intervention group, 40% identified as Hispanic, and 23% identified as non-Hispanic Black. About 59% reported Medicaid insurance. The intervention and control arms completed electronic surveys at 1, 3, 6, 9, and 12 months.
Average Asthma Control Test score increased from 19 to 22 in the intervention group, compared with an increase from 19 to 20 in the control group. Adjusted rates of emergency department visits and hospitalizations were greater in the intervention group (incidence rate ratios, 2.2 and 3.4, respectively). A measure of caregiver quality of life was greater in the intervention group, although the difference was not significant.
During the trial, more caregivers in the intervention group reported asthma attacks for which steroids were prescribed by a medical office (73% vs. 35%).
Some participants had to manually enter the number of daily puffs into the app because their inhalers were incompatible with the sensors. In addition, some data were missing because of incomplete or missing survey responses and sensor failure over time. “The number of intervention participants with actively transmitting sensors decreased from 102 at baseline to 56 at 12 months,” Dr. Gupta and associates noted.
Important area of research
“One interesting finding of this study is the increase in health care use in the intervention group to nearly twice as many emergency department (ED) visits and three times as many hospitalizations as the control group over 12 months,” Rachelle R. Ramsey, PhD, and Theresa W. Guilbert, MD, MS, of the University of Cincinnati, wrote in a related commentary. “Although it is plausible that, as the authors suggest, greater asthma knowledge and monitoring may have led to increased vigilance of asthma symptoms, it seems that this would have only led to an increase in ED visits but not hospitalizations.”
The mixture of objective electronic monitoring and subjective self-reported adherence may complicate interpretation of the results, they added.
“Overall, this article underscores the feasibility and importance of sensor-based electronic monitoring of adherence in pediatric asthma and encourages future research in this area,” Dr. Ramsey and Dr. Guilbert said.
The trial was supported by the UnitedHealth Group. Dr. Gupta has received grants from the National Institutes of Health, Rho, and other organizations, and has served as a medical consultant and adviser for a variety of companies. Dr. Ramsey is supported by the NIH. Dr. Guilbert reported fees from the American Board of Pediatrics, the Pediatric Pulmonary Subboard, and some pharmaceutical companies, plus grants from the NIH, grants and personal fees from Sanofi, Regeneron, and AstraZeneca, and royalties from UpToDate.
SOURCE: Gupta RS et al. Pediatrics. 2020 Dec 22. doi: 10.1542/peds.2020-1330.
Among children with moderate or severe persistent asthma, a randomized trial suggests.
But the intervention also may lead to more ED visits and increased hospitalization rates.
“We improved asthma symptom control but did not reduce health care use,” Ruchi S. Gupta, MD, MPH, and colleagues, wrote in a study published in Pediatrics.
The monitoring system alerted clinicians when a patient used a short-acting beta-agonist more than four times in a day. It could be that the “alerts enabled providers to detect asthma exacerbation virtually and refer for clinically appropriate care that included directing children to the ED,” the authors suggested. It also is possible that the intervention led caregivers to be more vigilant about symptoms and more empowered to seek care.
Adherence to preventive regimens
Many patients with asthma need to use preventive medications such as daily inhaled corticosteroids to control symptoms. Researchers have developed sensor-based inhaler monitoring interventions to improve treatment adherence, but the effectiveness of these interventions in improving asthma outcomes in urban and minority populations is unclear.
To assess the effectiveness of a clinically integrated, sensor-based inhaler monitoring intervention on improving asthma symptom control and related outcomes in children, Dr. Gupta, of Northwestern University and Ann & Robert H. Lurie Children’s Hospital of Chicago, and colleagues conducted a randomized, unblinded study, known as the Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial. They included 252 children: 127 in the control group and 125 in the intervention group.
Patients in the intervention group received Propeller Health’s Food and Drug Administration–cleared inhaler sensors for inhaled corticosteroids and short-acting beta-agonists. Caregivers could use a mobile application and clinicians could use a Web portal to track patients’ medication use. The app featured personalized insights, educational content, encouragement, surveys, and care team services.
Researchers recruited caregivers and children from five Chicago clinics for the study, which was conducted between 2016 and 2018. They included children aged 4-17 years who had a prescription for daily inhaled corticosteroids for at least 1 year before enrollment. In addition, participants had at least 1 exacerbation requiring oral corticosteroids in the previous year. They excluded children with other respiratory conditions. They also excluded participants who did not speak English because the app was available only in English.
“Sensors monitored inhaled medication use, capturing the date, time, and number of uses, and transmitted this information via Bluetooth to a paired smartphone and the provider portal in real-time,” the authors said.
Clinicians were alerted to call participants if a patient missed inhaled corticosteroid doses for 4 continuous days or used more than 4 short-acting beta-agonist doses per day. Clinicians could help guide asthma management, schedule an appointment, refill medications, and address technical difficulties with the sensors.
The intervention and control groups had similar baseline characteristics. About one-third of the patients were female, and the mean age was 9.3 years. In the control group, 28% identified as Hispanic, and 33% identified as non-Hispanic Black. In the intervention group, 40% identified as Hispanic, and 23% identified as non-Hispanic Black. About 59% reported Medicaid insurance. The intervention and control arms completed electronic surveys at 1, 3, 6, 9, and 12 months.
Average Asthma Control Test score increased from 19 to 22 in the intervention group, compared with an increase from 19 to 20 in the control group. Adjusted rates of emergency department visits and hospitalizations were greater in the intervention group (incidence rate ratios, 2.2 and 3.4, respectively). A measure of caregiver quality of life was greater in the intervention group, although the difference was not significant.
During the trial, more caregivers in the intervention group reported asthma attacks for which steroids were prescribed by a medical office (73% vs. 35%).
Some participants had to manually enter the number of daily puffs into the app because their inhalers were incompatible with the sensors. In addition, some data were missing because of incomplete or missing survey responses and sensor failure over time. “The number of intervention participants with actively transmitting sensors decreased from 102 at baseline to 56 at 12 months,” Dr. Gupta and associates noted.
Important area of research
“One interesting finding of this study is the increase in health care use in the intervention group to nearly twice as many emergency department (ED) visits and three times as many hospitalizations as the control group over 12 months,” Rachelle R. Ramsey, PhD, and Theresa W. Guilbert, MD, MS, of the University of Cincinnati, wrote in a related commentary. “Although it is plausible that, as the authors suggest, greater asthma knowledge and monitoring may have led to increased vigilance of asthma symptoms, it seems that this would have only led to an increase in ED visits but not hospitalizations.”
The mixture of objective electronic monitoring and subjective self-reported adherence may complicate interpretation of the results, they added.
“Overall, this article underscores the feasibility and importance of sensor-based electronic monitoring of adherence in pediatric asthma and encourages future research in this area,” Dr. Ramsey and Dr. Guilbert said.
The trial was supported by the UnitedHealth Group. Dr. Gupta has received grants from the National Institutes of Health, Rho, and other organizations, and has served as a medical consultant and adviser for a variety of companies. Dr. Ramsey is supported by the NIH. Dr. Guilbert reported fees from the American Board of Pediatrics, the Pediatric Pulmonary Subboard, and some pharmaceutical companies, plus grants from the NIH, grants and personal fees from Sanofi, Regeneron, and AstraZeneca, and royalties from UpToDate.
SOURCE: Gupta RS et al. Pediatrics. 2020 Dec 22. doi: 10.1542/peds.2020-1330.
FROM PEDIATRICS
One in five gestational carriers do not meet ASRM criteria
About 20% of gestational carriers at one institution did not meet recommended criteria developed by the American Society for Reproductive Medicine, according to a retrospective study of 194 patients.
The University of California, San Francisco, offers additional, stricter recommendations, including that gestational carriers have a body mass index less than 35. Under these stricter criteria, about 30% of the gestational carriers did not meet recommendations, Brett Stark, MD, MPH, reported at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.
Deviating from BMI or age recommendations may be associated with increased likelihood of spontaneous abortion, the analysis suggested. In addition, elements of a gestational carrier’s obstetric history not described in current guidelines, such as prior preterm birth, may influence gestational surrogacy outcomes.
The study was limited by incomplete information for some patients, the retrospective design, and the reliance on a relatively small cohort at a single center. Nevertheless, the findings potentially could inform discussions with patients, said Dr. Stark, a 3rd-year obstetrics and gynecology resident at the university.
Investigators aim to enroll patients in a longitudinal cohort study to further examine these questions, he said.
Protecting intended parents and carriers
“Gestational surrogacy has become an increasingly common form of third-party reproduction,” Dr. Stark said at the virtual meeting. The number of cases of in vitro fertilization (IVF) with gestational carriers increased from approximately 700 in 1999 to more than 5,500 in 2016, according to data from the Society for Assisted Reproductive Technology. “Despite the increasing prevalence of gestational carrier utilization, there remains limited guidance with regard to optimizing outcomes for both the intended parents and gestational carriers.”
ASRM and UCSF recommendations are based on expert opinion and include surprisingly little discussion about the prior pregnancy outcomes of potential gestational carriers, Dr. Stark said.
“It is important for all parties involved that we generate research and data that can help drive the development of the guidelines,” he said. Such evidence may help intended parents understand characteristics of gestational carriers that may lead to live births. “For the gestational carriers, it is important that we have information on safety so that they know they are making appropriate decisions for their family and their life.”
Gestational carrier characteristics in the present study that deviated from 2017 ASRM recommendations included age less than 21 years or greater than 45 years, mental health conditions, and having more than five prior deliveries.
“ASRM guidelines focused on criteria for gestational carriers are meant to protect infertile couples, the carrier, as well as the supporting agency,” Alan Penzias, MD, chair of ASRM’s Practice Committee who is in private practice in Boston, said in a society news release that highlighted Dr. Stark’s study. “It is important that gestational carriers have a complete medical history and examination, in addition to a psychological session with a mental health professional to ensure there are no reasons for the carrier to not move forward with pregnancy.”
A retrospective study by Kate Swanson, MD, and associates found that nonadherence to ASRM guidelines was associated with increased rates of cesarean delivery, neonatal morbidity, and preterm birth.
To examine how adherence to ASRM and UCSF recommendations relates to pregnancy outcomes and maternal and neonatal morbidity and death, Dr. Stark and colleagues assessed births from gestational carrier pregnancies at UCSF between 2008 and 2019.
Of 194 gestational carriers included in the analysis, 98.9% had a prior term pregnancy, 11.9% had a prior preterm pregnancy, and 17.5% had a prior spontaneous abortion.
Indications for use of gestational surrogates included serious medical condition of intended parent (25%), uterine factor infertility (23%), recurrent pregnancy loss (10%), and same-sex male couples (8%).
When the researchers compared pregnancy outcomes for gestational carriers who met ASRM guidelines with outcomes for 38 gestational carriers who did not meet ASRM guidelines, there were no statistically significant differences. Antepartum, intrapartum, and postpartum complication rates and cesarean delivery rates did not significantly differ based on ASRM guideline adherence.
Nonadherence to the stricter UCSF guidelines, however, was associated with increased likelihood of spontaneous abortion. In all, 23.7% of the 59 gestational carriers who were nonadherent to UCSF guidelines had a pregnancy end in a spontaneous abortion, compared with 6.7% of gestational carriers who were adherent to the UCSF recommendations (odds ratio, 4.35).
An analysis of individual criteria and poor pregnancy outcomes found that BMI greater than 35 was associated with increased likelihood of spontaneous abortion (OR, 4.29), as was age less than 21 years or greater than 45 years (OR, 3.37).
Prior spontaneous abortion was associated with increased likelihood of a biochemical pregnancy (OR, 3.2), and prior preterm birth was associated with increased likelihood of spontaneous abortion (OR, 3.19), previable delivery (OR, 25.2), cesarean delivery (OR, 2.59), and antepartum complications (OR, 3.56).
The role of agencies
About 76% of the gestational carriers had pregnancies mediated through a gestational surrogacy agency. Surrogates from agencies were about three times more likely than surrogates who were family, friends, or from private surrogacy arrangements to adhere to ASRM and UCSF guidelines.
Even after hearing about gestational carrier recommendations, patients may prefer to work with someone they know. “We want to provide our patients with evidence-based information if possible, but ultimately it is their decision to make,” Dr. Stark said. “And we just need to make sure that they are making an informed decision.”
Dr. Stark had no relevant disclosures. Dr. Penzias helped develop the ASRM committee opinion. He had no relevant conflicts of interest.
SOURCE: Stark B et al. ASRM 2020, Abstract O-251.
About 20% of gestational carriers at one institution did not meet recommended criteria developed by the American Society for Reproductive Medicine, according to a retrospective study of 194 patients.
The University of California, San Francisco, offers additional, stricter recommendations, including that gestational carriers have a body mass index less than 35. Under these stricter criteria, about 30% of the gestational carriers did not meet recommendations, Brett Stark, MD, MPH, reported at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.
Deviating from BMI or age recommendations may be associated with increased likelihood of spontaneous abortion, the analysis suggested. In addition, elements of a gestational carrier’s obstetric history not described in current guidelines, such as prior preterm birth, may influence gestational surrogacy outcomes.
The study was limited by incomplete information for some patients, the retrospective design, and the reliance on a relatively small cohort at a single center. Nevertheless, the findings potentially could inform discussions with patients, said Dr. Stark, a 3rd-year obstetrics and gynecology resident at the university.
Investigators aim to enroll patients in a longitudinal cohort study to further examine these questions, he said.
Protecting intended parents and carriers
“Gestational surrogacy has become an increasingly common form of third-party reproduction,” Dr. Stark said at the virtual meeting. The number of cases of in vitro fertilization (IVF) with gestational carriers increased from approximately 700 in 1999 to more than 5,500 in 2016, according to data from the Society for Assisted Reproductive Technology. “Despite the increasing prevalence of gestational carrier utilization, there remains limited guidance with regard to optimizing outcomes for both the intended parents and gestational carriers.”
ASRM and UCSF recommendations are based on expert opinion and include surprisingly little discussion about the prior pregnancy outcomes of potential gestational carriers, Dr. Stark said.
“It is important for all parties involved that we generate research and data that can help drive the development of the guidelines,” he said. Such evidence may help intended parents understand characteristics of gestational carriers that may lead to live births. “For the gestational carriers, it is important that we have information on safety so that they know they are making appropriate decisions for their family and their life.”
Gestational carrier characteristics in the present study that deviated from 2017 ASRM recommendations included age less than 21 years or greater than 45 years, mental health conditions, and having more than five prior deliveries.
“ASRM guidelines focused on criteria for gestational carriers are meant to protect infertile couples, the carrier, as well as the supporting agency,” Alan Penzias, MD, chair of ASRM’s Practice Committee who is in private practice in Boston, said in a society news release that highlighted Dr. Stark’s study. “It is important that gestational carriers have a complete medical history and examination, in addition to a psychological session with a mental health professional to ensure there are no reasons for the carrier to not move forward with pregnancy.”
A retrospective study by Kate Swanson, MD, and associates found that nonadherence to ASRM guidelines was associated with increased rates of cesarean delivery, neonatal morbidity, and preterm birth.
To examine how adherence to ASRM and UCSF recommendations relates to pregnancy outcomes and maternal and neonatal morbidity and death, Dr. Stark and colleagues assessed births from gestational carrier pregnancies at UCSF between 2008 and 2019.
Of 194 gestational carriers included in the analysis, 98.9% had a prior term pregnancy, 11.9% had a prior preterm pregnancy, and 17.5% had a prior spontaneous abortion.
Indications for use of gestational surrogates included serious medical condition of intended parent (25%), uterine factor infertility (23%), recurrent pregnancy loss (10%), and same-sex male couples (8%).
When the researchers compared pregnancy outcomes for gestational carriers who met ASRM guidelines with outcomes for 38 gestational carriers who did not meet ASRM guidelines, there were no statistically significant differences. Antepartum, intrapartum, and postpartum complication rates and cesarean delivery rates did not significantly differ based on ASRM guideline adherence.
Nonadherence to the stricter UCSF guidelines, however, was associated with increased likelihood of spontaneous abortion. In all, 23.7% of the 59 gestational carriers who were nonadherent to UCSF guidelines had a pregnancy end in a spontaneous abortion, compared with 6.7% of gestational carriers who were adherent to the UCSF recommendations (odds ratio, 4.35).
An analysis of individual criteria and poor pregnancy outcomes found that BMI greater than 35 was associated with increased likelihood of spontaneous abortion (OR, 4.29), as was age less than 21 years or greater than 45 years (OR, 3.37).
Prior spontaneous abortion was associated with increased likelihood of a biochemical pregnancy (OR, 3.2), and prior preterm birth was associated with increased likelihood of spontaneous abortion (OR, 3.19), previable delivery (OR, 25.2), cesarean delivery (OR, 2.59), and antepartum complications (OR, 3.56).
The role of agencies
About 76% of the gestational carriers had pregnancies mediated through a gestational surrogacy agency. Surrogates from agencies were about three times more likely than surrogates who were family, friends, or from private surrogacy arrangements to adhere to ASRM and UCSF guidelines.
Even after hearing about gestational carrier recommendations, patients may prefer to work with someone they know. “We want to provide our patients with evidence-based information if possible, but ultimately it is their decision to make,” Dr. Stark said. “And we just need to make sure that they are making an informed decision.”
Dr. Stark had no relevant disclosures. Dr. Penzias helped develop the ASRM committee opinion. He had no relevant conflicts of interest.
SOURCE: Stark B et al. ASRM 2020, Abstract O-251.
About 20% of gestational carriers at one institution did not meet recommended criteria developed by the American Society for Reproductive Medicine, according to a retrospective study of 194 patients.
The University of California, San Francisco, offers additional, stricter recommendations, including that gestational carriers have a body mass index less than 35. Under these stricter criteria, about 30% of the gestational carriers did not meet recommendations, Brett Stark, MD, MPH, reported at the American Society for Reproductive Medicine’s 2020 annual meeting, held virtually this year.
Deviating from BMI or age recommendations may be associated with increased likelihood of spontaneous abortion, the analysis suggested. In addition, elements of a gestational carrier’s obstetric history not described in current guidelines, such as prior preterm birth, may influence gestational surrogacy outcomes.
The study was limited by incomplete information for some patients, the retrospective design, and the reliance on a relatively small cohort at a single center. Nevertheless, the findings potentially could inform discussions with patients, said Dr. Stark, a 3rd-year obstetrics and gynecology resident at the university.
Investigators aim to enroll patients in a longitudinal cohort study to further examine these questions, he said.
Protecting intended parents and carriers
“Gestational surrogacy has become an increasingly common form of third-party reproduction,” Dr. Stark said at the virtual meeting. The number of cases of in vitro fertilization (IVF) with gestational carriers increased from approximately 700 in 1999 to more than 5,500 in 2016, according to data from the Society for Assisted Reproductive Technology. “Despite the increasing prevalence of gestational carrier utilization, there remains limited guidance with regard to optimizing outcomes for both the intended parents and gestational carriers.”
ASRM and UCSF recommendations are based on expert opinion and include surprisingly little discussion about the prior pregnancy outcomes of potential gestational carriers, Dr. Stark said.
“It is important for all parties involved that we generate research and data that can help drive the development of the guidelines,” he said. Such evidence may help intended parents understand characteristics of gestational carriers that may lead to live births. “For the gestational carriers, it is important that we have information on safety so that they know they are making appropriate decisions for their family and their life.”
Gestational carrier characteristics in the present study that deviated from 2017 ASRM recommendations included age less than 21 years or greater than 45 years, mental health conditions, and having more than five prior deliveries.
“ASRM guidelines focused on criteria for gestational carriers are meant to protect infertile couples, the carrier, as well as the supporting agency,” Alan Penzias, MD, chair of ASRM’s Practice Committee who is in private practice in Boston, said in a society news release that highlighted Dr. Stark’s study. “It is important that gestational carriers have a complete medical history and examination, in addition to a psychological session with a mental health professional to ensure there are no reasons for the carrier to not move forward with pregnancy.”
A retrospective study by Kate Swanson, MD, and associates found that nonadherence to ASRM guidelines was associated with increased rates of cesarean delivery, neonatal morbidity, and preterm birth.
To examine how adherence to ASRM and UCSF recommendations relates to pregnancy outcomes and maternal and neonatal morbidity and death, Dr. Stark and colleagues assessed births from gestational carrier pregnancies at UCSF between 2008 and 2019.
Of 194 gestational carriers included in the analysis, 98.9% had a prior term pregnancy, 11.9% had a prior preterm pregnancy, and 17.5% had a prior spontaneous abortion.
Indications for use of gestational surrogates included serious medical condition of intended parent (25%), uterine factor infertility (23%), recurrent pregnancy loss (10%), and same-sex male couples (8%).
When the researchers compared pregnancy outcomes for gestational carriers who met ASRM guidelines with outcomes for 38 gestational carriers who did not meet ASRM guidelines, there were no statistically significant differences. Antepartum, intrapartum, and postpartum complication rates and cesarean delivery rates did not significantly differ based on ASRM guideline adherence.
Nonadherence to the stricter UCSF guidelines, however, was associated with increased likelihood of spontaneous abortion. In all, 23.7% of the 59 gestational carriers who were nonadherent to UCSF guidelines had a pregnancy end in a spontaneous abortion, compared with 6.7% of gestational carriers who were adherent to the UCSF recommendations (odds ratio, 4.35).
An analysis of individual criteria and poor pregnancy outcomes found that BMI greater than 35 was associated with increased likelihood of spontaneous abortion (OR, 4.29), as was age less than 21 years or greater than 45 years (OR, 3.37).
Prior spontaneous abortion was associated with increased likelihood of a biochemical pregnancy (OR, 3.2), and prior preterm birth was associated with increased likelihood of spontaneous abortion (OR, 3.19), previable delivery (OR, 25.2), cesarean delivery (OR, 2.59), and antepartum complications (OR, 3.56).
The role of agencies
About 76% of the gestational carriers had pregnancies mediated through a gestational surrogacy agency. Surrogates from agencies were about three times more likely than surrogates who were family, friends, or from private surrogacy arrangements to adhere to ASRM and UCSF guidelines.
Even after hearing about gestational carrier recommendations, patients may prefer to work with someone they know. “We want to provide our patients with evidence-based information if possible, but ultimately it is their decision to make,” Dr. Stark said. “And we just need to make sure that they are making an informed decision.”
Dr. Stark had no relevant disclosures. Dr. Penzias helped develop the ASRM committee opinion. He had no relevant conflicts of interest.
SOURCE: Stark B et al. ASRM 2020, Abstract O-251.
FROM ASRM 2020
COVID-19 mortality rates declined, but vary by hospital
Mortality rates for inpatients with COVID-19 dropped significantly during the first 6 months of the pandemic, but outcomes depend on the hospital where patients receive care, new data show.
“[T]he characteristic that is most associated with poor or worsening hospital outcomes is high or increasing community case rates,” write David A. Asch, MD, MBA, executive director of the Center for Health Care Innovation at the University of Pennsylvania in Philadelphia, and colleagues.
The relationship between COVID-19 mortality rates and local disease prevalence suggests that “hospitals do worse when they are burdened with cases and is consistent with imperatives to flatten the curve,” the authors continue. “As case rates of COVID-19 increase across the nation, hospital mortality outcomes may worsen.”
The researchers published their study online December 22 in JAMA Internal Medicine.
The quick and substantial improvement in survival “is a tribute in part to new science — for example, the science that revealed the benefits of dexamethasone,” Asch told Medscape Medical News. “But it’s also a tribute to the doctors and nurses in the hospitals who developed experience. It’s a cliché to refer to them as heroes, but that is what they are. The science and the heroic experience continues on, and so I’m optimistic that we’ll see even more improvement over time.”
However, the data also indicate that “with lots of disease in the community, hospitals may have a harder time keeping patients alive,” Asch said. “And of course the reason this is bad news is that community level case rates are rising all over, and in some cases at rapid rates. With that rise, we might be giving back some of our past gains in survival — just as the vaccine is beginning to be distributed.”
Examining mortality trends
The researchers analyzed administrative claims data from a large national health insurer. They included data from 38,517 adults who were admitted with COVID-19 to 955 US hospitals between January 1 and June 30 of this year. The investigators estimated hospitals’ risk-standardized rate of 30-day in-hospital mortality or referral to hospice, adjusted for patient-level characteristics.
Overall, 3179 patients (8.25%) died, and 1433 patients (3.7%) were referred to hospice. Risk-standardized mortality or hospice referral rates for individual hospitals ranged from 5.7% to 24.7%. The average rate was 9.1% in the best-performing quintile, compared with 15.7% in the worst-performing quintile.
In a subset of 398 hospitals that had at least 10 patients admitted for COVID-19 during early (January 1 through April 30) and later periods (between May 1 and June 30), rates in all but one hospital improved, and 94% improved by at least 25%. The average risk-standardized event rate declined from 16.6% to 9.3%.
“That rate of relative improvement is striking and encouraging, but perhaps not surprising,” Asch and coauthors write. “Early efforts at treating patients with COVID-19 were based on experience with previously known causes of severe respiratory illness. Later efforts could draw on experiences specific to SARS-CoV-2 infection.”
For instance, doctors tried different inpatient management approaches, such as early vs late assisted ventilation, differences in oxygen flow, prone or supine positioning, and anticoagulation. “Those efforts varied in how systematically they were evaluated, but our results suggest that valuable experience was gained,” the authors note.
In addition, variation between hospitals could reflect differences in quality or different admission thresholds, they continue.
The study provides “a reason for optimism that our healthcare system has improved in our ability to care for persons with COVID-19,” write Leon Boudourakis, MD, MHS, and Amit Uppal, MD, in a related commentary. Boudourakis and Uppal are both affiliated with NYC Health + Hospitals in New York City and with SUNY Downstate and New York University School of Medicine, respectively.
Similar improvements in mortality rates have been reported in the United Kingdom and in a New York City hospital system, the editorialists note. The lower mortality rates may represent clinical, healthcare system, and epidemiologic trends.
“Since the first wave of serious COVID-19 cases, physicians have learned a great deal about the best ways to treat this serious infection,” they say. “Steroids may decrease mortality in patients with respiratory failure. Remdesivir may shorten hospitalizations of patients with serious illness. Anticoagulation and prone positioning may help certain patients. Using noninvasive ventilation and high-flow oxygen therapy may spare subsets of patients from the harms of intubation, such as ventilator-induced lung injury.»
Overwhelmed hospitals
“Hospitals do not perform as well when they are overwhelmed,” which may be a reason for the correlation between community prevalence and mortality rates, Boudourakis and Uppal suggested. “In particular, patients with a precarious respiratory status require expert, meticulous therapy to avoid intubation; those who undergo intubation or have kidney failure require nuanced and timely expert care with ventilatory adjustments and kidney replacement therapy, which are difficult to perform optimally when hospital capacity is strained.”
Although the death rate has fallen to about 9% for hospitalized patients, “9% is still high,” Asch said.
“Our results show that hospitals can’t do it on their own,” Asch said. “They need all of us to keep the community spread of the disease down. The right answer now is the right answer since the beginning of the pandemic: Keep your distance, wash your hands, and wear a mask.”
Asch, Boudourakis, and Uppal have disclosed no relevant financial relationships. A study coauthor reported personal fees and grants from pharmaceutical companies outside the submitted work.
A version of this article first appeared on Medscape.com.
Mortality rates for inpatients with COVID-19 dropped significantly during the first 6 months of the pandemic, but outcomes depend on the hospital where patients receive care, new data show.
“[T]he characteristic that is most associated with poor or worsening hospital outcomes is high or increasing community case rates,” write David A. Asch, MD, MBA, executive director of the Center for Health Care Innovation at the University of Pennsylvania in Philadelphia, and colleagues.
The relationship between COVID-19 mortality rates and local disease prevalence suggests that “hospitals do worse when they are burdened with cases and is consistent with imperatives to flatten the curve,” the authors continue. “As case rates of COVID-19 increase across the nation, hospital mortality outcomes may worsen.”
The researchers published their study online December 22 in JAMA Internal Medicine.
The quick and substantial improvement in survival “is a tribute in part to new science — for example, the science that revealed the benefits of dexamethasone,” Asch told Medscape Medical News. “But it’s also a tribute to the doctors and nurses in the hospitals who developed experience. It’s a cliché to refer to them as heroes, but that is what they are. The science and the heroic experience continues on, and so I’m optimistic that we’ll see even more improvement over time.”
However, the data also indicate that “with lots of disease in the community, hospitals may have a harder time keeping patients alive,” Asch said. “And of course the reason this is bad news is that community level case rates are rising all over, and in some cases at rapid rates. With that rise, we might be giving back some of our past gains in survival — just as the vaccine is beginning to be distributed.”
Examining mortality trends
The researchers analyzed administrative claims data from a large national health insurer. They included data from 38,517 adults who were admitted with COVID-19 to 955 US hospitals between January 1 and June 30 of this year. The investigators estimated hospitals’ risk-standardized rate of 30-day in-hospital mortality or referral to hospice, adjusted for patient-level characteristics.
Overall, 3179 patients (8.25%) died, and 1433 patients (3.7%) were referred to hospice. Risk-standardized mortality or hospice referral rates for individual hospitals ranged from 5.7% to 24.7%. The average rate was 9.1% in the best-performing quintile, compared with 15.7% in the worst-performing quintile.
In a subset of 398 hospitals that had at least 10 patients admitted for COVID-19 during early (January 1 through April 30) and later periods (between May 1 and June 30), rates in all but one hospital improved, and 94% improved by at least 25%. The average risk-standardized event rate declined from 16.6% to 9.3%.
“That rate of relative improvement is striking and encouraging, but perhaps not surprising,” Asch and coauthors write. “Early efforts at treating patients with COVID-19 were based on experience with previously known causes of severe respiratory illness. Later efforts could draw on experiences specific to SARS-CoV-2 infection.”
For instance, doctors tried different inpatient management approaches, such as early vs late assisted ventilation, differences in oxygen flow, prone or supine positioning, and anticoagulation. “Those efforts varied in how systematically they were evaluated, but our results suggest that valuable experience was gained,” the authors note.
In addition, variation between hospitals could reflect differences in quality or different admission thresholds, they continue.
The study provides “a reason for optimism that our healthcare system has improved in our ability to care for persons with COVID-19,” write Leon Boudourakis, MD, MHS, and Amit Uppal, MD, in a related commentary. Boudourakis and Uppal are both affiliated with NYC Health + Hospitals in New York City and with SUNY Downstate and New York University School of Medicine, respectively.
Similar improvements in mortality rates have been reported in the United Kingdom and in a New York City hospital system, the editorialists note. The lower mortality rates may represent clinical, healthcare system, and epidemiologic trends.
“Since the first wave of serious COVID-19 cases, physicians have learned a great deal about the best ways to treat this serious infection,” they say. “Steroids may decrease mortality in patients with respiratory failure. Remdesivir may shorten hospitalizations of patients with serious illness. Anticoagulation and prone positioning may help certain patients. Using noninvasive ventilation and high-flow oxygen therapy may spare subsets of patients from the harms of intubation, such as ventilator-induced lung injury.»
Overwhelmed hospitals
“Hospitals do not perform as well when they are overwhelmed,” which may be a reason for the correlation between community prevalence and mortality rates, Boudourakis and Uppal suggested. “In particular, patients with a precarious respiratory status require expert, meticulous therapy to avoid intubation; those who undergo intubation or have kidney failure require nuanced and timely expert care with ventilatory adjustments and kidney replacement therapy, which are difficult to perform optimally when hospital capacity is strained.”
Although the death rate has fallen to about 9% for hospitalized patients, “9% is still high,” Asch said.
“Our results show that hospitals can’t do it on their own,” Asch said. “They need all of us to keep the community spread of the disease down. The right answer now is the right answer since the beginning of the pandemic: Keep your distance, wash your hands, and wear a mask.”
Asch, Boudourakis, and Uppal have disclosed no relevant financial relationships. A study coauthor reported personal fees and grants from pharmaceutical companies outside the submitted work.
A version of this article first appeared on Medscape.com.
Mortality rates for inpatients with COVID-19 dropped significantly during the first 6 months of the pandemic, but outcomes depend on the hospital where patients receive care, new data show.
“[T]he characteristic that is most associated with poor or worsening hospital outcomes is high or increasing community case rates,” write David A. Asch, MD, MBA, executive director of the Center for Health Care Innovation at the University of Pennsylvania in Philadelphia, and colleagues.
The relationship between COVID-19 mortality rates and local disease prevalence suggests that “hospitals do worse when they are burdened with cases and is consistent with imperatives to flatten the curve,” the authors continue. “As case rates of COVID-19 increase across the nation, hospital mortality outcomes may worsen.”
The researchers published their study online December 22 in JAMA Internal Medicine.
The quick and substantial improvement in survival “is a tribute in part to new science — for example, the science that revealed the benefits of dexamethasone,” Asch told Medscape Medical News. “But it’s also a tribute to the doctors and nurses in the hospitals who developed experience. It’s a cliché to refer to them as heroes, but that is what they are. The science and the heroic experience continues on, and so I’m optimistic that we’ll see even more improvement over time.”
However, the data also indicate that “with lots of disease in the community, hospitals may have a harder time keeping patients alive,” Asch said. “And of course the reason this is bad news is that community level case rates are rising all over, and in some cases at rapid rates. With that rise, we might be giving back some of our past gains in survival — just as the vaccine is beginning to be distributed.”
Examining mortality trends
The researchers analyzed administrative claims data from a large national health insurer. They included data from 38,517 adults who were admitted with COVID-19 to 955 US hospitals between January 1 and June 30 of this year. The investigators estimated hospitals’ risk-standardized rate of 30-day in-hospital mortality or referral to hospice, adjusted for patient-level characteristics.
Overall, 3179 patients (8.25%) died, and 1433 patients (3.7%) were referred to hospice. Risk-standardized mortality or hospice referral rates for individual hospitals ranged from 5.7% to 24.7%. The average rate was 9.1% in the best-performing quintile, compared with 15.7% in the worst-performing quintile.
In a subset of 398 hospitals that had at least 10 patients admitted for COVID-19 during early (January 1 through April 30) and later periods (between May 1 and June 30), rates in all but one hospital improved, and 94% improved by at least 25%. The average risk-standardized event rate declined from 16.6% to 9.3%.
“That rate of relative improvement is striking and encouraging, but perhaps not surprising,” Asch and coauthors write. “Early efforts at treating patients with COVID-19 were based on experience with previously known causes of severe respiratory illness. Later efforts could draw on experiences specific to SARS-CoV-2 infection.”
For instance, doctors tried different inpatient management approaches, such as early vs late assisted ventilation, differences in oxygen flow, prone or supine positioning, and anticoagulation. “Those efforts varied in how systematically they were evaluated, but our results suggest that valuable experience was gained,” the authors note.
In addition, variation between hospitals could reflect differences in quality or different admission thresholds, they continue.
The study provides “a reason for optimism that our healthcare system has improved in our ability to care for persons with COVID-19,” write Leon Boudourakis, MD, MHS, and Amit Uppal, MD, in a related commentary. Boudourakis and Uppal are both affiliated with NYC Health + Hospitals in New York City and with SUNY Downstate and New York University School of Medicine, respectively.
Similar improvements in mortality rates have been reported in the United Kingdom and in a New York City hospital system, the editorialists note. The lower mortality rates may represent clinical, healthcare system, and epidemiologic trends.
“Since the first wave of serious COVID-19 cases, physicians have learned a great deal about the best ways to treat this serious infection,” they say. “Steroids may decrease mortality in patients with respiratory failure. Remdesivir may shorten hospitalizations of patients with serious illness. Anticoagulation and prone positioning may help certain patients. Using noninvasive ventilation and high-flow oxygen therapy may spare subsets of patients from the harms of intubation, such as ventilator-induced lung injury.»
Overwhelmed hospitals
“Hospitals do not perform as well when they are overwhelmed,” which may be a reason for the correlation between community prevalence and mortality rates, Boudourakis and Uppal suggested. “In particular, patients with a precarious respiratory status require expert, meticulous therapy to avoid intubation; those who undergo intubation or have kidney failure require nuanced and timely expert care with ventilatory adjustments and kidney replacement therapy, which are difficult to perform optimally when hospital capacity is strained.”
Although the death rate has fallen to about 9% for hospitalized patients, “9% is still high,” Asch said.
“Our results show that hospitals can’t do it on their own,” Asch said. “They need all of us to keep the community spread of the disease down. The right answer now is the right answer since the beginning of the pandemic: Keep your distance, wash your hands, and wear a mask.”
Asch, Boudourakis, and Uppal have disclosed no relevant financial relationships. A study coauthor reported personal fees and grants from pharmaceutical companies outside the submitted work.
A version of this article first appeared on Medscape.com.