Diana Swift

Children who regularly slept 10-plus hours per night, particularly just before starting kindergarten, transitioned more successfully to kindergarten than those with less regular sleeping patterns, an observational study found. The effect held across the kindergarten year regardless of socioeconomic and health covariates, according to a new study by Douglas M. Teti, PhD, a developmental scientist and a professor of pediatrics at Penn State University, University Park, and colleagues.

“These effects were ubiquitous, extending to socioemotional learning engagement and academic domains,” they wrote online in Pediatrics

Furthermore, it was the regularity of sufficient nocturnal sleep that appeared to be more important for school adjustment than overall amounts of sleep accumulated across the day or the proportion of 24-hour periods in which children got 10 or more hours of sleep.

The American Academy of Sleep Medicine has recommended that 3- to 5-year-olds get 10-13 hours of sleep per day, including naps.

The findings by Dr. Teti’s group suggest that family-based interventions to establish consistent patterns of sufficient nighttime sleep should begin 5 or 6 months before the start of kindergarten.

“The importance of sleep as a predictor of school functioning in children is well-established, but relatively less is known about how sleep impacts children as they make their first transition into formal schooling,” Dr. Teti told this news organization. “School readiness and adjustment can be impacted by many factors, including socioeconomic status, child health, and missed days of school, but few studies have isolated the role of sleep in the transition to kindergarten net of these other influences, and few studies have examined the role that sleep plays on children’s school functioning throughout the full kindergarten year.”
 

The study

During 2016-2019, the researcher recruited 230 families from three Pennsylvania school districts, of which 221 completed the study. At several time points, the study examined three different measures of child sleep duration in 7-day bursts: at pre-kindergarten (July to August), early kindergarten (late September), mid-kindergarten (late November), and late kindergarten (mid-to-late April), using wrist actigraphy. These measures included:

• mean amounts of child sleep per 24-hour period across the full week
• proportion of 24-hour periods per week that children slept 10 or more hours
• proportion of nighttime sleep periods per week that children slept 10 or more hours

Outcomes at the designated school year time points were provided by 64 teachers blinded to the pupils’ sleep histories and by assessments administered by project staff.

Among the sleep measures examined, regularity of nighttime sleep involving 10 or more hours of sleep over the nocturnal period, especially at the pre-kindergarten stage, consistently predicted more favorable outcomes in socioemotional, learning engagement, and academic domains. These findings were controlled for income-to-poverty threshold ratios, child health status, and number of missed school days.

The study results generally align with those of previous studies, showing the importance of sleep for children’s school functioning, Dr. Teti told this news organization. “But they differed significantly in terms of finding that it was the regularity of 10-plus hours concentrated during the nighttime sleep period that was most important for predicting school adjustment, in particular, regular or sufficient sleep that occurred prior to the start of kindergarten.”

Calling the study “thought provoking,” Michael B. Grosso, MD, chair of pediatrics at Huntington (N.Y.) Hospital, said it confirms a robust correlation between total sleep duration and outcomes important to successful adjustment to kindergarten. “And we find out that uninterrupted sleep time of 10 hours or more seems to matter as well.”

In his view, the biggest limitation to the analysis is the one inherent to any observational study, “which is that association cannot prove causality. The authors did attempt to control for other health factors, but that can be hard to do,” he said. “The point is that if a child faces any of several health challenges, from sleep apnea to uncontrolled asthma, to ADHD or an autistic spectrum disorder, those issues will cause disrupted, abnormal sleep and also interfere with the outcomes the study addresses. In other words, it’s hard to know if sleep is affecting kindergarten adjustment or whether some X factor is affecting sleep and also affecting kindergarten performance.”

Getting children into bed earlier in long bright evenings of spring and summer before onset of kindergarten may not be easy, Dr. Teti acknowledged. “Arranging children’s sleep schedule as they approach kindergarten so that most, if not all, of their sleep takes place during the night – and as a corollary, reducing the frequency of naps during the day – should help children shift into sleeping nighttime primarily if not exclusively,” he said.

If necessary, he added, parents can work with sleep professionals to gradually concentrate children’s sleep during the night. They should normalize earlier bedtimes by reducing access to electronic screens before bedtime and removing televisions from their bedrooms. “A consistent bedtime routine should be a central feature of parental attempts to shape better, more regular sleep in their children.”

Dr. Grosso added that pediatricians need to talk about the importance of consistent routines and especially adequate sleep when counseling parents during pre-school health supervision visits. “And as the authors mention, it’s hard to ensure good sleep hygiene for children if parents aren’t also getting a good night sleep. It all goes together.”

This study was supported by the National Institutes of Health. The authors had no competing interests to declare. Dr. Grosso disclosed no relevant conflicts of interest.

Children who regularly slept 10-plus hours per night, particularly just before starting kindergarten, transitioned more successfully to kindergarten than those with less regular sleeping patterns, an observational study found. The effect held across the kindergarten year regardless of socioeconomic and health covariates, according to a new study by Douglas M. Teti, PhD, a developmental scientist and a professor of pediatrics at Penn State University, University Park, and colleagues.

“These effects were ubiquitous, extending to socioemotional learning engagement and academic domains,” they wrote online in Pediatrics

Furthermore, it was the regularity of sufficient nocturnal sleep that appeared to be more important for school adjustment than overall amounts of sleep accumulated across the day or the proportion of 24-hour periods in which children got 10 or more hours of sleep.

The American Academy of Sleep Medicine has recommended that 3- to 5-year-olds get 10-13 hours of sleep per day, including naps.

The findings by Dr. Teti’s group suggest that family-based interventions to establish consistent patterns of sufficient nighttime sleep should begin 5 or 6 months before the start of kindergarten.

“The importance of sleep as a predictor of school functioning in children is well-established, but relatively less is known about how sleep impacts children as they make their first transition into formal schooling,” Dr. Teti told this news organization. “School readiness and adjustment can be impacted by many factors, including socioeconomic status, child health, and missed days of school, but few studies have isolated the role of sleep in the transition to kindergarten net of these other influences, and few studies have examined the role that sleep plays on children’s school functioning throughout the full kindergarten year.”
 

The study

During 2016-2019, the researcher recruited 230 families from three Pennsylvania school districts, of which 221 completed the study. At several time points, the study examined three different measures of child sleep duration in 7-day bursts: at pre-kindergarten (July to August), early kindergarten (late September), mid-kindergarten (late November), and late kindergarten (mid-to-late April), using wrist actigraphy. These measures included:

• mean amounts of child sleep per 24-hour period across the full week
• proportion of 24-hour periods per week that children slept 10 or more hours
• proportion of nighttime sleep periods per week that children slept 10 or more hours

Outcomes at the designated school year time points were provided by 64 teachers blinded to the pupils’ sleep histories and by assessments administered by project staff.

Among the sleep measures examined, regularity of nighttime sleep involving 10 or more hours of sleep over the nocturnal period, especially at the pre-kindergarten stage, consistently predicted more favorable outcomes in socioemotional, learning engagement, and academic domains. These findings were controlled for income-to-poverty threshold ratios, child health status, and number of missed school days.

The study results generally align with those of previous studies, showing the importance of sleep for children’s school functioning, Dr. Teti told this news organization. “But they differed significantly in terms of finding that it was the regularity of 10-plus hours concentrated during the nighttime sleep period that was most important for predicting school adjustment, in particular, regular or sufficient sleep that occurred prior to the start of kindergarten.”

Calling the study “thought provoking,” Michael B. Grosso, MD, chair of pediatrics at Huntington (N.Y.) Hospital, said it confirms a robust correlation between total sleep duration and outcomes important to successful adjustment to kindergarten. “And we find out that uninterrupted sleep time of 10 hours or more seems to matter as well.”

In his view, the biggest limitation to the analysis is the one inherent to any observational study, “which is that association cannot prove causality. The authors did attempt to control for other health factors, but that can be hard to do,” he said. “The point is that if a child faces any of several health challenges, from sleep apnea to uncontrolled asthma, to ADHD or an autistic spectrum disorder, those issues will cause disrupted, abnormal sleep and also interfere with the outcomes the study addresses. In other words, it’s hard to know if sleep is affecting kindergarten adjustment or whether some X factor is affecting sleep and also affecting kindergarten performance.”

Getting children into bed earlier in long bright evenings of spring and summer before onset of kindergarten may not be easy, Dr. Teti acknowledged. “Arranging children’s sleep schedule as they approach kindergarten so that most, if not all, of their sleep takes place during the night – and as a corollary, reducing the frequency of naps during the day – should help children shift into sleeping nighttime primarily if not exclusively,” he said.

If necessary, he added, parents can work with sleep professionals to gradually concentrate children’s sleep during the night. They should normalize earlier bedtimes by reducing access to electronic screens before bedtime and removing televisions from their bedrooms. “A consistent bedtime routine should be a central feature of parental attempts to shape better, more regular sleep in their children.”

Dr. Grosso added that pediatricians need to talk about the importance of consistent routines and especially adequate sleep when counseling parents during pre-school health supervision visits. “And as the authors mention, it’s hard to ensure good sleep hygiene for children if parents aren’t also getting a good night sleep. It all goes together.”

This study was supported by the National Institutes of Health. The authors had no competing interests to declare. Dr. Grosso disclosed no relevant conflicts of interest.

Children who regularly slept 10-plus hours per night, particularly just before starting kindergarten, transitioned more successfully to kindergarten than those with less regular sleeping patterns, an observational study found. The effect held across the kindergarten year regardless of socioeconomic and health covariates, according to a new study by Douglas M. Teti, PhD, a developmental scientist and a professor of pediatrics at Penn State University, University Park, and colleagues.

“These effects were ubiquitous, extending to socioemotional learning engagement and academic domains,” they wrote online in Pediatrics

Furthermore, it was the regularity of sufficient nocturnal sleep that appeared to be more important for school adjustment than overall amounts of sleep accumulated across the day or the proportion of 24-hour periods in which children got 10 or more hours of sleep.

The American Academy of Sleep Medicine has recommended that 3- to 5-year-olds get 10-13 hours of sleep per day, including naps.

The findings by Dr. Teti’s group suggest that family-based interventions to establish consistent patterns of sufficient nighttime sleep should begin 5 or 6 months before the start of kindergarten.

“The importance of sleep as a predictor of school functioning in children is well-established, but relatively less is known about how sleep impacts children as they make their first transition into formal schooling,” Dr. Teti told this news organization. “School readiness and adjustment can be impacted by many factors, including socioeconomic status, child health, and missed days of school, but few studies have isolated the role of sleep in the transition to kindergarten net of these other influences, and few studies have examined the role that sleep plays on children’s school functioning throughout the full kindergarten year.”
 

The study

During 2016-2019, the researcher recruited 230 families from three Pennsylvania school districts, of which 221 completed the study. At several time points, the study examined three different measures of child sleep duration in 7-day bursts: at pre-kindergarten (July to August), early kindergarten (late September), mid-kindergarten (late November), and late kindergarten (mid-to-late April), using wrist actigraphy. These measures included:

• mean amounts of child sleep per 24-hour period across the full week
• proportion of 24-hour periods per week that children slept 10 or more hours
• proportion of nighttime sleep periods per week that children slept 10 or more hours

Outcomes at the designated school year time points were provided by 64 teachers blinded to the pupils’ sleep histories and by assessments administered by project staff.

Among the sleep measures examined, regularity of nighttime sleep involving 10 or more hours of sleep over the nocturnal period, especially at the pre-kindergarten stage, consistently predicted more favorable outcomes in socioemotional, learning engagement, and academic domains. These findings were controlled for income-to-poverty threshold ratios, child health status, and number of missed school days.

The study results generally align with those of previous studies, showing the importance of sleep for children’s school functioning, Dr. Teti told this news organization. “But they differed significantly in terms of finding that it was the regularity of 10-plus hours concentrated during the nighttime sleep period that was most important for predicting school adjustment, in particular, regular or sufficient sleep that occurred prior to the start of kindergarten.”

Calling the study “thought provoking,” Michael B. Grosso, MD, chair of pediatrics at Huntington (N.Y.) Hospital, said it confirms a robust correlation between total sleep duration and outcomes important to successful adjustment to kindergarten. “And we find out that uninterrupted sleep time of 10 hours or more seems to matter as well.”

In his view, the biggest limitation to the analysis is the one inherent to any observational study, “which is that association cannot prove causality. The authors did attempt to control for other health factors, but that can be hard to do,” he said. “The point is that if a child faces any of several health challenges, from sleep apnea to uncontrolled asthma, to ADHD or an autistic spectrum disorder, those issues will cause disrupted, abnormal sleep and also interfere with the outcomes the study addresses. In other words, it’s hard to know if sleep is affecting kindergarten adjustment or whether some X factor is affecting sleep and also affecting kindergarten performance.”

Getting children into bed earlier in long bright evenings of spring and summer before onset of kindergarten may not be easy, Dr. Teti acknowledged. “Arranging children’s sleep schedule as they approach kindergarten so that most, if not all, of their sleep takes place during the night – and as a corollary, reducing the frequency of naps during the day – should help children shift into sleeping nighttime primarily if not exclusively,” he said.

If necessary, he added, parents can work with sleep professionals to gradually concentrate children’s sleep during the night. They should normalize earlier bedtimes by reducing access to electronic screens before bedtime and removing televisions from their bedrooms. “A consistent bedtime routine should be a central feature of parental attempts to shape better, more regular sleep in their children.”

Dr. Grosso added that pediatricians need to talk about the importance of consistent routines and especially adequate sleep when counseling parents during pre-school health supervision visits. “And as the authors mention, it’s hard to ensure good sleep hygiene for children if parents aren’t also getting a good night sleep. It all goes together.”

This study was supported by the National Institutes of Health. The authors had no competing interests to declare. Dr. Grosso disclosed no relevant conflicts of interest.

U.S. maternal deaths – those during pregnancy or within 42 days of pregnancy – increased substantially by 33.3% after March 2020 corresponding to the COVID-19 pandemic onset, according to new research published in JAMA Network Open.

Data from the National Center for Health Statistics (NCHS) revealed this rise in maternal deaths was higher than the 22% overall excess death estimate associated with the pandemic in 2020.

Increases were highest for Hispanic and non-Hispanic Black women, exacerbating already high rates of disparity in comparison with White women, wrote Marie E. Thoma, PhD, an associate professor at the University of Maryland, College Park, and Eugene R. Declercq, PhD, a professor at Boston University.

The authors noted that this spike in maternal deaths might be caused either by conditions directly related to COVID-19, such as respiratory or viral infections, or by conditions worsened by pandemic-associated health care disruptions including those for diabetes or cardiovascular disease.

The precise causes, however, could not be discerned from the data, the authors noted.

The NCHS reported an 18.4% increase in U.S. maternal mortality from 2019 to 2020. The relative increase was 44.4% among Hispanic, 25.7% among non-Hispanic Black, and 6.1% among non-Hispanic White women.

“The rise in maternal mortality among Hispanic women was unprecedented,” Dr. Thoma said in an interview. Given a 16.8% increase in overall U.S. mortality in 2020, largely attributed to the COVID-19 pandemic, the authors examined the pandemic’s role in [the higher] maternal death rates for 2020.

“Prior to this report, the NCHS released an e-report that there had been a rise in maternal mortality in 2020, but questions remained about the role of the pandemic in this rise that their report hadn’t addressed,” Dr. Thoma said in an interview “So we decided to look at the data further to assess whether the rise coincided with the pandemic and how this differed by race/ethnicity, whether there were changes in the causes of maternal death, and how often COVID-19 was listed as a contributory factor in those deaths.”

A total of 1,588 maternal deaths (18.8 per 100,000 live births) occurred before the pandemic versus 684 deaths (25.1 per 100,000 live births) during the 2020 phase of the pandemic, for a relative increase of 33.3%.

Direct obstetrical causes of death included diabetes, hypertensive and liver disorders, pregnancy-related infections, and obstetrical hemorrhage and embolism. Indirect causes comprised, among others, nonobstetrical infections and diseases of the circulatory and respiratory systems as well as mental and nervous disorders.

Relative increases in direct causes (27.7%) were mostly associated with diabetes (95.9%), hypertensive disorders (39.0%), and other specified pregnancy-related conditions (48.0%).

COVID-19 was commonly listed as a lethal condition along with other viral diseases (16 of 16 deaths and diseases of the respiratory system (11 of 19 deaths).

Late maternal mortality – defined as more than 42 days but less than 1 year after pregnancy – increased by 41%. “This was surprising as we might anticipate risk being higher during pregnancy given that pregnant women may be more susceptible, but we see that this rise was also found among people in the later postpartum period,” Dr. Thoma said.

Absolute and relative changes were highest for Hispanic women (8.9 per 100,000 live births and 74.2%, respectively) and non-Hispanic Black women (16.8 per 100,000 live births and 40.2%). In contrast, non-Hispanic White women saw increases of just 2.9 per 100,000 live births and 17.2%.

“Overall, we found the rise in maternal mortality in 2020 was concentrated after the start of pandemic, particularly for non-Hispanic Black and Hispanic women, and we saw a dramatic rise in respiratory-related conditions,” Dr. Thoma said.

In a comment, Steven Woolf, MD, MPH, director emeritus of the Center on Society and Health at Virginia Commonwealth University, Richmond, said the findings are very consistent with his and others research showing dramatic increases in overall death rates from many causes during the pandemic, with these ranging from COVID-19 leading conditions such as diabetes, cardiovascular and Alzheimer’s disease to less-studied causes such as drug overdoses and alcoholism caused by the stresses of the pandemic. Again, deaths were likely caused by both COVID-19 infections and disruptions in diagnosis and care.

“So a rise in maternal mortality would unfortunately also be expected, and these researchers have shown that,” he said in an interview. In addition, they have confirmed “the pattern of stark health disparities in the Hispanic and Black populations relative to the White. Our group has shown marked decreases in the life expectancies of the Black and Hispanic populations relative to the White population.”

While he might take issue with the study’s research methodology, Dr. Woolf said, “The work is useful partly because we need to work out the best research methods to do this kind of analysis because we really need to understand the effects on maternal mortality.”

He said sorting out the best way to do this type of research will be important for looking at excess deaths and maternal mortality following other events, for example, in the wake of the Supreme Court’s recent decision to reverse Roe v. Wade.

The authors acknowledged certain study limitations, including the large percentage of COVID-19 cases with a nonspecific underlying cause. According to Dr. Thoma and Dr. Declercq, that reflects a maternal death coding problem that needs to be addressed, as well as a partitioning of data. The latter resulted in small numbers for some categories, with rates suppressed for fewer than 16 deaths because of reduced reliability.

“We found that more specific information is often available on death certificates but is lost in the process of coding,” said Dr. Thoma. “We were able to reclassify many of these causes to a more specific cause that we attributed to be the primary cause of death.”

The authors said future studies of maternal death should examine the contribution of the pandemic to racial and ethnic disparities and should identify specific causes of maternal deaths overall and associated with COVID-19.

In earlier research, the authors previously warned of possible misclassifications of maternal deaths.

They found evidence of both underreporting and overreporting of deaths, with possible overreporting predominant, whereas accurate data are essential for measuring the effectiveness of maternal mortality reduction programs.

Dr. Thoma’s group will continue to monitor mortality trends with the release of 2021 data. “We hope we will see improvements in 2021 given greater access to vaccines, treatments, and fewer health care disruptions,” Dr. Thoma said. “It will be important to continue to stress the importance of COVID-19 vaccines for pregnant and postpartum people.”

This study had no external funding. The authors disclosed no competing interests. Dr. Woolf declared no conflicts of interest.

U.S. maternal deaths – those during pregnancy or within 42 days of pregnancy – increased substantially by 33.3% after March 2020 corresponding to the COVID-19 pandemic onset, according to new research published in JAMA Network Open.

Data from the National Center for Health Statistics (NCHS) revealed this rise in maternal deaths was higher than the 22% overall excess death estimate associated with the pandemic in 2020.

Increases were highest for Hispanic and non-Hispanic Black women, exacerbating already high rates of disparity in comparison with White women, wrote Marie E. Thoma, PhD, an associate professor at the University of Maryland, College Park, and Eugene R. Declercq, PhD, a professor at Boston University.

The authors noted that this spike in maternal deaths might be caused either by conditions directly related to COVID-19, such as respiratory or viral infections, or by conditions worsened by pandemic-associated health care disruptions including those for diabetes or cardiovascular disease.

The precise causes, however, could not be discerned from the data, the authors noted.

The NCHS reported an 18.4% increase in U.S. maternal mortality from 2019 to 2020. The relative increase was 44.4% among Hispanic, 25.7% among non-Hispanic Black, and 6.1% among non-Hispanic White women.

“The rise in maternal mortality among Hispanic women was unprecedented,” Dr. Thoma said in an interview. Given a 16.8% increase in overall U.S. mortality in 2020, largely attributed to the COVID-19 pandemic, the authors examined the pandemic’s role in [the higher] maternal death rates for 2020.

“Prior to this report, the NCHS released an e-report that there had been a rise in maternal mortality in 2020, but questions remained about the role of the pandemic in this rise that their report hadn’t addressed,” Dr. Thoma said in an interview “So we decided to look at the data further to assess whether the rise coincided with the pandemic and how this differed by race/ethnicity, whether there were changes in the causes of maternal death, and how often COVID-19 was listed as a contributory factor in those deaths.”

A total of 1,588 maternal deaths (18.8 per 100,000 live births) occurred before the pandemic versus 684 deaths (25.1 per 100,000 live births) during the 2020 phase of the pandemic, for a relative increase of 33.3%.

Direct obstetrical causes of death included diabetes, hypertensive and liver disorders, pregnancy-related infections, and obstetrical hemorrhage and embolism. Indirect causes comprised, among others, nonobstetrical infections and diseases of the circulatory and respiratory systems as well as mental and nervous disorders.

Relative increases in direct causes (27.7%) were mostly associated with diabetes (95.9%), hypertensive disorders (39.0%), and other specified pregnancy-related conditions (48.0%).

COVID-19 was commonly listed as a lethal condition along with other viral diseases (16 of 16 deaths and diseases of the respiratory system (11 of 19 deaths).

Late maternal mortality – defined as more than 42 days but less than 1 year after pregnancy – increased by 41%. “This was surprising as we might anticipate risk being higher during pregnancy given that pregnant women may be more susceptible, but we see that this rise was also found among people in the later postpartum period,” Dr. Thoma said.

Absolute and relative changes were highest for Hispanic women (8.9 per 100,000 live births and 74.2%, respectively) and non-Hispanic Black women (16.8 per 100,000 live births and 40.2%). In contrast, non-Hispanic White women saw increases of just 2.9 per 100,000 live births and 17.2%.

“Overall, we found the rise in maternal mortality in 2020 was concentrated after the start of pandemic, particularly for non-Hispanic Black and Hispanic women, and we saw a dramatic rise in respiratory-related conditions,” Dr. Thoma said.

In a comment, Steven Woolf, MD, MPH, director emeritus of the Center on Society and Health at Virginia Commonwealth University, Richmond, said the findings are very consistent with his and others research showing dramatic increases in overall death rates from many causes during the pandemic, with these ranging from COVID-19 leading conditions such as diabetes, cardiovascular and Alzheimer’s disease to less-studied causes such as drug overdoses and alcoholism caused by the stresses of the pandemic. Again, deaths were likely caused by both COVID-19 infections and disruptions in diagnosis and care.

“So a rise in maternal mortality would unfortunately also be expected, and these researchers have shown that,” he said in an interview. In addition, they have confirmed “the pattern of stark health disparities in the Hispanic and Black populations relative to the White. Our group has shown marked decreases in the life expectancies of the Black and Hispanic populations relative to the White population.”

While he might take issue with the study’s research methodology, Dr. Woolf said, “The work is useful partly because we need to work out the best research methods to do this kind of analysis because we really need to understand the effects on maternal mortality.”

He said sorting out the best way to do this type of research will be important for looking at excess deaths and maternal mortality following other events, for example, in the wake of the Supreme Court’s recent decision to reverse Roe v. Wade.

The authors acknowledged certain study limitations, including the large percentage of COVID-19 cases with a nonspecific underlying cause. According to Dr. Thoma and Dr. Declercq, that reflects a maternal death coding problem that needs to be addressed, as well as a partitioning of data. The latter resulted in small numbers for some categories, with rates suppressed for fewer than 16 deaths because of reduced reliability.

“We found that more specific information is often available on death certificates but is lost in the process of coding,” said Dr. Thoma. “We were able to reclassify many of these causes to a more specific cause that we attributed to be the primary cause of death.”

The authors said future studies of maternal death should examine the contribution of the pandemic to racial and ethnic disparities and should identify specific causes of maternal deaths overall and associated with COVID-19.

In earlier research, the authors previously warned of possible misclassifications of maternal deaths.

They found evidence of both underreporting and overreporting of deaths, with possible overreporting predominant, whereas accurate data are essential for measuring the effectiveness of maternal mortality reduction programs.

Dr. Thoma’s group will continue to monitor mortality trends with the release of 2021 data. “We hope we will see improvements in 2021 given greater access to vaccines, treatments, and fewer health care disruptions,” Dr. Thoma said. “It will be important to continue to stress the importance of COVID-19 vaccines for pregnant and postpartum people.”

This study had no external funding. The authors disclosed no competing interests. Dr. Woolf declared no conflicts of interest.

U.S. maternal deaths – those during pregnancy or within 42 days of pregnancy – increased substantially by 33.3% after March 2020 corresponding to the COVID-19 pandemic onset, according to new research published in JAMA Network Open.

Data from the National Center for Health Statistics (NCHS) revealed this rise in maternal deaths was higher than the 22% overall excess death estimate associated with the pandemic in 2020.

Increases were highest for Hispanic and non-Hispanic Black women, exacerbating already high rates of disparity in comparison with White women, wrote Marie E. Thoma, PhD, an associate professor at the University of Maryland, College Park, and Eugene R. Declercq, PhD, a professor at Boston University.

The authors noted that this spike in maternal deaths might be caused either by conditions directly related to COVID-19, such as respiratory or viral infections, or by conditions worsened by pandemic-associated health care disruptions including those for diabetes or cardiovascular disease.

The precise causes, however, could not be discerned from the data, the authors noted.

The NCHS reported an 18.4% increase in U.S. maternal mortality from 2019 to 2020. The relative increase was 44.4% among Hispanic, 25.7% among non-Hispanic Black, and 6.1% among non-Hispanic White women.

“The rise in maternal mortality among Hispanic women was unprecedented,” Dr. Thoma said in an interview. Given a 16.8% increase in overall U.S. mortality in 2020, largely attributed to the COVID-19 pandemic, the authors examined the pandemic’s role in [the higher] maternal death rates for 2020.

“Prior to this report, the NCHS released an e-report that there had been a rise in maternal mortality in 2020, but questions remained about the role of the pandemic in this rise that their report hadn’t addressed,” Dr. Thoma said in an interview “So we decided to look at the data further to assess whether the rise coincided with the pandemic and how this differed by race/ethnicity, whether there were changes in the causes of maternal death, and how often COVID-19 was listed as a contributory factor in those deaths.”

A total of 1,588 maternal deaths (18.8 per 100,000 live births) occurred before the pandemic versus 684 deaths (25.1 per 100,000 live births) during the 2020 phase of the pandemic, for a relative increase of 33.3%.

Direct obstetrical causes of death included diabetes, hypertensive and liver disorders, pregnancy-related infections, and obstetrical hemorrhage and embolism. Indirect causes comprised, among others, nonobstetrical infections and diseases of the circulatory and respiratory systems as well as mental and nervous disorders.

Relative increases in direct causes (27.7%) were mostly associated with diabetes (95.9%), hypertensive disorders (39.0%), and other specified pregnancy-related conditions (48.0%).

COVID-19 was commonly listed as a lethal condition along with other viral diseases (16 of 16 deaths and diseases of the respiratory system (11 of 19 deaths).

Late maternal mortality – defined as more than 42 days but less than 1 year after pregnancy – increased by 41%. “This was surprising as we might anticipate risk being higher during pregnancy given that pregnant women may be more susceptible, but we see that this rise was also found among people in the later postpartum period,” Dr. Thoma said.

Absolute and relative changes were highest for Hispanic women (8.9 per 100,000 live births and 74.2%, respectively) and non-Hispanic Black women (16.8 per 100,000 live births and 40.2%). In contrast, non-Hispanic White women saw increases of just 2.9 per 100,000 live births and 17.2%.

“Overall, we found the rise in maternal mortality in 2020 was concentrated after the start of pandemic, particularly for non-Hispanic Black and Hispanic women, and we saw a dramatic rise in respiratory-related conditions,” Dr. Thoma said.

In a comment, Steven Woolf, MD, MPH, director emeritus of the Center on Society and Health at Virginia Commonwealth University, Richmond, said the findings are very consistent with his and others research showing dramatic increases in overall death rates from many causes during the pandemic, with these ranging from COVID-19 leading conditions such as diabetes, cardiovascular and Alzheimer’s disease to less-studied causes such as drug overdoses and alcoholism caused by the stresses of the pandemic. Again, deaths were likely caused by both COVID-19 infections and disruptions in diagnosis and care.

“So a rise in maternal mortality would unfortunately also be expected, and these researchers have shown that,” he said in an interview. In addition, they have confirmed “the pattern of stark health disparities in the Hispanic and Black populations relative to the White. Our group has shown marked decreases in the life expectancies of the Black and Hispanic populations relative to the White population.”

While he might take issue with the study’s research methodology, Dr. Woolf said, “The work is useful partly because we need to work out the best research methods to do this kind of analysis because we really need to understand the effects on maternal mortality.”

He said sorting out the best way to do this type of research will be important for looking at excess deaths and maternal mortality following other events, for example, in the wake of the Supreme Court’s recent decision to reverse Roe v. Wade.

The authors acknowledged certain study limitations, including the large percentage of COVID-19 cases with a nonspecific underlying cause. According to Dr. Thoma and Dr. Declercq, that reflects a maternal death coding problem that needs to be addressed, as well as a partitioning of data. The latter resulted in small numbers for some categories, with rates suppressed for fewer than 16 deaths because of reduced reliability.

“We found that more specific information is often available on death certificates but is lost in the process of coding,” said Dr. Thoma. “We were able to reclassify many of these causes to a more specific cause that we attributed to be the primary cause of death.”

The authors said future studies of maternal death should examine the contribution of the pandemic to racial and ethnic disparities and should identify specific causes of maternal deaths overall and associated with COVID-19.

In earlier research, the authors previously warned of possible misclassifications of maternal deaths.

They found evidence of both underreporting and overreporting of deaths, with possible overreporting predominant, whereas accurate data are essential for measuring the effectiveness of maternal mortality reduction programs.

Dr. Thoma’s group will continue to monitor mortality trends with the release of 2021 data. “We hope we will see improvements in 2021 given greater access to vaccines, treatments, and fewer health care disruptions,” Dr. Thoma said. “It will be important to continue to stress the importance of COVID-19 vaccines for pregnant and postpartum people.”

This study had no external funding. The authors disclosed no competing interests. Dr. Woolf declared no conflicts of interest.

Human papilloma virus (HPV) vaccination coverage of at least one dose significantly increased in U.S. adolescents from 56.1% in 2015 to 75.4% in 2020, according to the National Immunization Survey–Teen (NIS-Teen).

The telephone survey, conducted among the parents or guardians of children ages 13-17, found a faster increase in coverage among males than females: 4.7 percentage points annually versus 2.7 percentage points annually. With yearly overall survey samples ranging from 21,875 to 17,970, these coverage differences between males and females narrowed over the 5 years of the survey period.

The difference between coverage among males and females decreased from 13 to 3 percentage points. Traditionally, parents of boys have been less likely to vaccinate their sons against HPV.

Despite the increase in uptake, however, in 2020 about 25% of adolescents had not received at least one dose of HPV vaccine. “Targeted strategies are needed to increase coverage and narrow down inequalities,” Peng-jun Lu, MD, PhD, of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote in Pediatrics.

In other NIS-Teen findings:

• Coverage in 2020 was 73.7% for males and 76.8% for females (P < .05).
• Coverage rose to 80.7% for those with a provider recommendation but was only 51.7% for those without one (P < .05).
• The rate was 80.3% for those with a well-child visit at age 11-12 years and 64.8% for those without (P < .05).
• In multivariable logistic regression, the main characteristics independently associated with a higher likelihood of vaccination included a provider recommendation, age 16-17 years, and being non-Hispanic Black, Hispanic, American Indian, or Alaskan Native.
• Other predictors of vaccination included having Medicaid insurance and having a mother who was widowed, divorced, or separated, or had no more than a high school education.
• Also predictive was having two or more provider contacts in the past 12 months, a well-child visit at age 11-12 years, and one or two vaccine providers (P < .05).
• Coverage among adolescents living in non-metropolitan statistical areas was significantly lower than those living in MSA principal cities in all years assessed (P < .05).

Provider recommendation remains significant and has historically been highly associated with HPV vaccination. In the 2012 NIS-Teen, for example, 15% of parents not intending to have their daughters vaccinated in the next 12 months cited the lack of a provider recommendation.

“To increase HPV vaccination coverage and further reduce HPV-related morbidity and mortality, providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives the HPV vaccine and other needed vaccines,” Dr. Lu and associates wrote. But 18.5% of parents in the survey received no provider recommendation.

“Of note, we found that teenagers who had mothers with more education or who live in more rural communities had a lower likelihood of receiving vaccination against HPV,” Dr. Lu told this news organization. “Further research should be conducted to better understand these findings.”

According to Margaret E. Thew, DNP, FNP-BC, director of adolescent medicine at the Medical College of Wisconsin in Milwaukee, several studies have highlighted resistance to the vaccine among better-educated parents. “Parents with higher education associate the HPV vaccine with sexual activity and consequently refuse,” said Ms. Thew, who was not involved in the NIS-Teen study. “They mistakenly assume that their children are not sexually active and they lack the understanding that HPV is one of the biggest causes of oral cancer.”

Human papilloma virus (HPV) vaccination coverage of at least one dose significantly increased in U.S. adolescents from 56.1% in 2015 to 75.4% in 2020, according to the National Immunization Survey–Teen (NIS-Teen).

The telephone survey, conducted among the parents or guardians of children ages 13-17, found a faster increase in coverage among males than females: 4.7 percentage points annually versus 2.7 percentage points annually. With yearly overall survey samples ranging from 21,875 to 17,970, these coverage differences between males and females narrowed over the 5 years of the survey period.

The difference between coverage among males and females decreased from 13 to 3 percentage points. Traditionally, parents of boys have been less likely to vaccinate their sons against HPV.

Despite the increase in uptake, however, in 2020 about 25% of adolescents had not received at least one dose of HPV vaccine. “Targeted strategies are needed to increase coverage and narrow down inequalities,” Peng-jun Lu, MD, PhD, of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote in Pediatrics.

In other NIS-Teen findings:

• Coverage in 2020 was 73.7% for males and 76.8% for females (P < .05).
• Coverage rose to 80.7% for those with a provider recommendation but was only 51.7% for those without one (P < .05).
• The rate was 80.3% for those with a well-child visit at age 11-12 years and 64.8% for those without (P < .05).
• In multivariable logistic regression, the main characteristics independently associated with a higher likelihood of vaccination included a provider recommendation, age 16-17 years, and being non-Hispanic Black, Hispanic, American Indian, or Alaskan Native.
• Other predictors of vaccination included having Medicaid insurance and having a mother who was widowed, divorced, or separated, or had no more than a high school education.
• Also predictive was having two or more provider contacts in the past 12 months, a well-child visit at age 11-12 years, and one or two vaccine providers (P < .05).
• Coverage among adolescents living in non-metropolitan statistical areas was significantly lower than those living in MSA principal cities in all years assessed (P < .05).

Provider recommendation remains significant and has historically been highly associated with HPV vaccination. In the 2012 NIS-Teen, for example, 15% of parents not intending to have their daughters vaccinated in the next 12 months cited the lack of a provider recommendation.

“To increase HPV vaccination coverage and further reduce HPV-related morbidity and mortality, providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives the HPV vaccine and other needed vaccines,” Dr. Lu and associates wrote. But 18.5% of parents in the survey received no provider recommendation.

“Of note, we found that teenagers who had mothers with more education or who live in more rural communities had a lower likelihood of receiving vaccination against HPV,” Dr. Lu told this news organization. “Further research should be conducted to better understand these findings.”

According to Margaret E. Thew, DNP, FNP-BC, director of adolescent medicine at the Medical College of Wisconsin in Milwaukee, several studies have highlighted resistance to the vaccine among better-educated parents. “Parents with higher education associate the HPV vaccine with sexual activity and consequently refuse,” said Ms. Thew, who was not involved in the NIS-Teen study. “They mistakenly assume that their children are not sexually active and they lack the understanding that HPV is one of the biggest causes of oral cancer.”

Human papilloma virus (HPV) vaccination coverage of at least one dose significantly increased in U.S. adolescents from 56.1% in 2015 to 75.4% in 2020, according to the National Immunization Survey–Teen (NIS-Teen).

The telephone survey, conducted among the parents or guardians of children ages 13-17, found a faster increase in coverage among males than females: 4.7 percentage points annually versus 2.7 percentage points annually. With yearly overall survey samples ranging from 21,875 to 17,970, these coverage differences between males and females narrowed over the 5 years of the survey period.

The difference between coverage among males and females decreased from 13 to 3 percentage points. Traditionally, parents of boys have been less likely to vaccinate their sons against HPV.

Despite the increase in uptake, however, in 2020 about 25% of adolescents had not received at least one dose of HPV vaccine. “Targeted strategies are needed to increase coverage and narrow down inequalities,” Peng-jun Lu, MD, PhD, of the National Center for Immunization and Respiratory Diseases at the Centers for Disease Control and Prevention in Atlanta, and colleagues wrote in Pediatrics.

In other NIS-Teen findings:

• Coverage in 2020 was 73.7% for males and 76.8% for females (P < .05).
• Coverage rose to 80.7% for those with a provider recommendation but was only 51.7% for those without one (P < .05).
• The rate was 80.3% for those with a well-child visit at age 11-12 years and 64.8% for those without (P < .05).
• In multivariable logistic regression, the main characteristics independently associated with a higher likelihood of vaccination included a provider recommendation, age 16-17 years, and being non-Hispanic Black, Hispanic, American Indian, or Alaskan Native.
• Other predictors of vaccination included having Medicaid insurance and having a mother who was widowed, divorced, or separated, or had no more than a high school education.
• Also predictive was having two or more provider contacts in the past 12 months, a well-child visit at age 11-12 years, and one or two vaccine providers (P < .05).
• Coverage among adolescents living in non-metropolitan statistical areas was significantly lower than those living in MSA principal cities in all years assessed (P < .05).

Provider recommendation remains significant and has historically been highly associated with HPV vaccination. In the 2012 NIS-Teen, for example, 15% of parents not intending to have their daughters vaccinated in the next 12 months cited the lack of a provider recommendation.

“To increase HPV vaccination coverage and further reduce HPV-related morbidity and mortality, providers, parents, and adolescents should use every health care visit as a chance to review vaccination histories and ensure that every adolescent receives the HPV vaccine and other needed vaccines,” Dr. Lu and associates wrote. But 18.5% of parents in the survey received no provider recommendation.

“Of note, we found that teenagers who had mothers with more education or who live in more rural communities had a lower likelihood of receiving vaccination against HPV,” Dr. Lu told this news organization. “Further research should be conducted to better understand these findings.”

According to Margaret E. Thew, DNP, FNP-BC, director of adolescent medicine at the Medical College of Wisconsin in Milwaukee, several studies have highlighted resistance to the vaccine among better-educated parents. “Parents with higher education associate the HPV vaccine with sexual activity and consequently refuse,” said Ms. Thew, who was not involved in the NIS-Teen study. “They mistakenly assume that their children are not sexually active and they lack the understanding that HPV is one of the biggest causes of oral cancer.”

Extended-release methylphenidate (Concerta) had no effect on learning academic material taught in a small group of children with attention-deficit/hyperactivity disorder (ADHD), a controlled crossover study found.

As in previous studies, however, the stimulant did improve seat work productivity and classroom behavior, but these benefits did not translate into better learning of individual academic learning units, according to William E. Pelham Jr., PhD, of the department of psychology at Florida International University in Miami, and colleagues.

The results were published online in the Journal of Consulting and Clinical Psychology.

The authors said the finding raises questions about how stimulant medication leads to improved academic achievement over time. “This is important given that many parents and pediatricians believe that medication will improve academic achievement; parents are more likely to pursue medication (vs. other treatment options) when they identify academic achievement as a primary goal for treatment. The current findings suggest this emphasis may be misguided,” they wrote.

In their view, efforts to improve learning in children with ADHD should focus on delivering effective academic instruction and support such as individualized educational plans rather than stimulant therapy.
 

The study

The study cohort consisted of 173 children aged 7-12 (77% male, 86% Hispanic) who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria for ADHD and were participating in a therapeutic summer camp classroom.

The experimental design was a triple-masked, within-subject, AB/BA crossover trial. Children completed two consecutive phases of daily, 25-minute instruction in both subject-area content (science and social studies) and vocabulary. Each phase was a standard instructional unit lasting for 3 weeks and lessons were given by credentialed teachers via small-group, evidence-based instruction.

Each child was randomized to receive daily osmotic-release oral system methylphenidate (OROS-MPH) during either the first or second instructional phase and to receive placebo during the other.

Seat work referred to the amount of work a pupil completed in a fixed duration of independent work time, and classroom behavior referred to the frequency of violating classroom rules. Learning was measured by tests, and multilevel models were fit separately to the subject and vocabulary test scores, with four observations per child: pretest and posttest in the two academic subject areas.

The results showed that medication had large, salutary, statistically significant effects on children’s academic seat work productivity and classroom behavior on every single day of the instructional period.

Pupils completed 37% more arithmetic problems per minute when taking OROS-MPH and committed 53% fewer rule violations per hour. In terms of learning the material taught during instruction, however, tests showed that children learned the same amount of subject-area and vocabulary content whether they were taking OROS-MPH or placebo during the instructional period.

Consistent with previous studies, medication slightly helped to improve test scores when taken on the day of a test, but not enough to boost most children’s grades. For example, medication helped children increase on average 1.7 percentage points out of 100 on science and social studies tests.

“This finding has relevance for parents deciding whether to medicate their child for occasions such as a psychoeducational evaluation or high-stakes academic testing – while the effect size was small, findings suggest being medicated would improve scores,” the investigators wrote.

Sharing his perspective on the study but not involved in it, Herschel R. Lessin, MD, a pediatrician at The Children’s Medical Group in Poughkeepsie, N.Y., and coauthor of the American Academy of Pediatrics (AAP) guidelines on ADHD, said, “If you ignore the sensationalized headlines, this study is an interesting but preliminary first step, and justifies further research on the topic. It also has several potential defects, which the authors in fact address in the supplements.” The cohort size was small, for example, the doses of medication were very low, and the study took place in a controlled therapeutic setting – not the everyday classroom.

“Stimulant medications are targeting these core behavioral symptoms of ADHD ... but the goal of treatment is more than just the reduction of symptoms; it is to improve a child’s overall functioning so that they succeed at what is expected of them and avoid developing even more impairments,” Dr. Harris said, adding that symptom improvement can sometimes allow a child to learn better in the classroom and achieve more academically.

Children with ADHD may have diagnosed or undiagnosed comorbid learning disabilities, with one 2013 study suggesting a rate of 31%-45%.

With such learning disabilities being distinct from core behavioral symptoms, stimulant medications would not be expected to address a child’s learning disability. “In fact, best practice is for a child with ADHD who is not responding to stimulant medication (doctors might refer to this as complex ADHD) to undergo full individual evaluations either through the school system or an outside psychological assessment to assess for potential learning disabilities or other comorbid developmental/learning or psychiatric diagnosis,” Dr. Harris said.

Rather than changing prescribing patterns, she continued, pediatricians could consider advising parents to request learning evaluations through the school system if the child continues to struggle academically with no change in learning outcomes despite improvement in some behavioral outcomes.

As a reference, Dr. Harris recommended the Society for Developmental and Behavioral Pediatrics guidelines for complex ADHD.

This study was funded by the National Institute on Mental Health with additional support from the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, and the Institute of Education Sciences. Coauthor James Waxmonsky, MD, has received research funding from the National Institutes of Health, Supernus, and Pfizer and served on the advisory board for Iron Shore, NLS Pharma, and Purdue Pharma.

Extended-release methylphenidate (Concerta) had no effect on learning academic material taught in a small group of children with attention-deficit/hyperactivity disorder (ADHD), a controlled crossover study found.

As in previous studies, however, the stimulant did improve seat work productivity and classroom behavior, but these benefits did not translate into better learning of individual academic learning units, according to William E. Pelham Jr., PhD, of the department of psychology at Florida International University in Miami, and colleagues.

The results were published online in the Journal of Consulting and Clinical Psychology.

The authors said the finding raises questions about how stimulant medication leads to improved academic achievement over time. “This is important given that many parents and pediatricians believe that medication will improve academic achievement; parents are more likely to pursue medication (vs. other treatment options) when they identify academic achievement as a primary goal for treatment. The current findings suggest this emphasis may be misguided,” they wrote.

In their view, efforts to improve learning in children with ADHD should focus on delivering effective academic instruction and support such as individualized educational plans rather than stimulant therapy.
 

The study

The study cohort consisted of 173 children aged 7-12 (77% male, 86% Hispanic) who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria for ADHD and were participating in a therapeutic summer camp classroom.

The experimental design was a triple-masked, within-subject, AB/BA crossover trial. Children completed two consecutive phases of daily, 25-minute instruction in both subject-area content (science and social studies) and vocabulary. Each phase was a standard instructional unit lasting for 3 weeks and lessons were given by credentialed teachers via small-group, evidence-based instruction.

Each child was randomized to receive daily osmotic-release oral system methylphenidate (OROS-MPH) during either the first or second instructional phase and to receive placebo during the other.

Seat work referred to the amount of work a pupil completed in a fixed duration of independent work time, and classroom behavior referred to the frequency of violating classroom rules. Learning was measured by tests, and multilevel models were fit separately to the subject and vocabulary test scores, with four observations per child: pretest and posttest in the two academic subject areas.

The results showed that medication had large, salutary, statistically significant effects on children’s academic seat work productivity and classroom behavior on every single day of the instructional period.

Pupils completed 37% more arithmetic problems per minute when taking OROS-MPH and committed 53% fewer rule violations per hour. In terms of learning the material taught during instruction, however, tests showed that children learned the same amount of subject-area and vocabulary content whether they were taking OROS-MPH or placebo during the instructional period.

Consistent with previous studies, medication slightly helped to improve test scores when taken on the day of a test, but not enough to boost most children’s grades. For example, medication helped children increase on average 1.7 percentage points out of 100 on science and social studies tests.

“This finding has relevance for parents deciding whether to medicate their child for occasions such as a psychoeducational evaluation or high-stakes academic testing – while the effect size was small, findings suggest being medicated would improve scores,” the investigators wrote.

Sharing his perspective on the study but not involved in it, Herschel R. Lessin, MD, a pediatrician at The Children’s Medical Group in Poughkeepsie, N.Y., and coauthor of the American Academy of Pediatrics (AAP) guidelines on ADHD, said, “If you ignore the sensationalized headlines, this study is an interesting but preliminary first step, and justifies further research on the topic. It also has several potential defects, which the authors in fact address in the supplements.” The cohort size was small, for example, the doses of medication were very low, and the study took place in a controlled therapeutic setting – not the everyday classroom.

“Stimulant medications are targeting these core behavioral symptoms of ADHD ... but the goal of treatment is more than just the reduction of symptoms; it is to improve a child’s overall functioning so that they succeed at what is expected of them and avoid developing even more impairments,” Dr. Harris said, adding that symptom improvement can sometimes allow a child to learn better in the classroom and achieve more academically.

Children with ADHD may have diagnosed or undiagnosed comorbid learning disabilities, with one 2013 study suggesting a rate of 31%-45%.

With such learning disabilities being distinct from core behavioral symptoms, stimulant medications would not be expected to address a child’s learning disability. “In fact, best practice is for a child with ADHD who is not responding to stimulant medication (doctors might refer to this as complex ADHD) to undergo full individual evaluations either through the school system or an outside psychological assessment to assess for potential learning disabilities or other comorbid developmental/learning or psychiatric diagnosis,” Dr. Harris said.

Rather than changing prescribing patterns, she continued, pediatricians could consider advising parents to request learning evaluations through the school system if the child continues to struggle academically with no change in learning outcomes despite improvement in some behavioral outcomes.

As a reference, Dr. Harris recommended the Society for Developmental and Behavioral Pediatrics guidelines for complex ADHD.

This study was funded by the National Institute on Mental Health with additional support from the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, and the Institute of Education Sciences. Coauthor James Waxmonsky, MD, has received research funding from the National Institutes of Health, Supernus, and Pfizer and served on the advisory board for Iron Shore, NLS Pharma, and Purdue Pharma.

Extended-release methylphenidate (Concerta) had no effect on learning academic material taught in a small group of children with attention-deficit/hyperactivity disorder (ADHD), a controlled crossover study found.

As in previous studies, however, the stimulant did improve seat work productivity and classroom behavior, but these benefits did not translate into better learning of individual academic learning units, according to William E. Pelham Jr., PhD, of the department of psychology at Florida International University in Miami, and colleagues.

The results were published online in the Journal of Consulting and Clinical Psychology.

The authors said the finding raises questions about how stimulant medication leads to improved academic achievement over time. “This is important given that many parents and pediatricians believe that medication will improve academic achievement; parents are more likely to pursue medication (vs. other treatment options) when they identify academic achievement as a primary goal for treatment. The current findings suggest this emphasis may be misguided,” they wrote.

In their view, efforts to improve learning in children with ADHD should focus on delivering effective academic instruction and support such as individualized educational plans rather than stimulant therapy.
 

The study

The study cohort consisted of 173 children aged 7-12 (77% male, 86% Hispanic) who met Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, criteria for ADHD and were participating in a therapeutic summer camp classroom.

The experimental design was a triple-masked, within-subject, AB/BA crossover trial. Children completed two consecutive phases of daily, 25-minute instruction in both subject-area content (science and social studies) and vocabulary. Each phase was a standard instructional unit lasting for 3 weeks and lessons were given by credentialed teachers via small-group, evidence-based instruction.

Each child was randomized to receive daily osmotic-release oral system methylphenidate (OROS-MPH) during either the first or second instructional phase and to receive placebo during the other.

Seat work referred to the amount of work a pupil completed in a fixed duration of independent work time, and classroom behavior referred to the frequency of violating classroom rules. Learning was measured by tests, and multilevel models were fit separately to the subject and vocabulary test scores, with four observations per child: pretest and posttest in the two academic subject areas.

The results showed that medication had large, salutary, statistically significant effects on children’s academic seat work productivity and classroom behavior on every single day of the instructional period.

Pupils completed 37% more arithmetic problems per minute when taking OROS-MPH and committed 53% fewer rule violations per hour. In terms of learning the material taught during instruction, however, tests showed that children learned the same amount of subject-area and vocabulary content whether they were taking OROS-MPH or placebo during the instructional period.

Consistent with previous studies, medication slightly helped to improve test scores when taken on the day of a test, but not enough to boost most children’s grades. For example, medication helped children increase on average 1.7 percentage points out of 100 on science and social studies tests.

“This finding has relevance for parents deciding whether to medicate their child for occasions such as a psychoeducational evaluation or high-stakes academic testing – while the effect size was small, findings suggest being medicated would improve scores,” the investigators wrote.

Sharing his perspective on the study but not involved in it, Herschel R. Lessin, MD, a pediatrician at The Children’s Medical Group in Poughkeepsie, N.Y., and coauthor of the American Academy of Pediatrics (AAP) guidelines on ADHD, said, “If you ignore the sensationalized headlines, this study is an interesting but preliminary first step, and justifies further research on the topic. It also has several potential defects, which the authors in fact address in the supplements.” The cohort size was small, for example, the doses of medication were very low, and the study took place in a controlled therapeutic setting – not the everyday classroom.

“Stimulant medications are targeting these core behavioral symptoms of ADHD ... but the goal of treatment is more than just the reduction of symptoms; it is to improve a child’s overall functioning so that they succeed at what is expected of them and avoid developing even more impairments,” Dr. Harris said, adding that symptom improvement can sometimes allow a child to learn better in the classroom and achieve more academically.

Children with ADHD may have diagnosed or undiagnosed comorbid learning disabilities, with one 2013 study suggesting a rate of 31%-45%.

With such learning disabilities being distinct from core behavioral symptoms, stimulant medications would not be expected to address a child’s learning disability. “In fact, best practice is for a child with ADHD who is not responding to stimulant medication (doctors might refer to this as complex ADHD) to undergo full individual evaluations either through the school system or an outside psychological assessment to assess for potential learning disabilities or other comorbid developmental/learning or psychiatric diagnosis,” Dr. Harris said.

Rather than changing prescribing patterns, she continued, pediatricians could consider advising parents to request learning evaluations through the school system if the child continues to struggle academically with no change in learning outcomes despite improvement in some behavioral outcomes.

As a reference, Dr. Harris recommended the Society for Developmental and Behavioral Pediatrics guidelines for complex ADHD.

This study was funded by the National Institute on Mental Health with additional support from the National Institute on Alcohol Abuse and Alcoholism, the National Institute on Drug Abuse, and the Institute of Education Sciences. Coauthor James Waxmonsky, MD, has received research funding from the National Institutes of Health, Supernus, and Pfizer and served on the advisory board for Iron Shore, NLS Pharma, and Purdue Pharma.

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

Cesarean births are not likely linked to an elevated risk of food allergy during the first year of life, an Australian study found.

Published online in the Journal of Allergy and Clinical Immunology, the findings may help assess the risks and benefits of cesarean delivery and reassure women who require it that their babies are not more likely to develop food allergy, according to Rachel L. Peters, PhD, an epidemiologist at the Murdoch Child Research Institute (MCRI) in Melbourne, and colleagues.

Dr. Peters’ group undertook the analysis to clarify a possible association between mode of delivery and food allergy risk, which has remained unclear owing to the absence of studies with both challenge-proven food allergy outcomes and detailed information on the type and timing of cesarean delivery.

“The infant immune system undergoes rapid development during the neonatal period,” Dr. Peters said in an MCRI press release, and the mode of delivery may interfere with the normal development of the immune system. “Babies born by cesarean have less exposure to the bacteria from the mother’s gut and vagina, which influence the composition of the baby’s microbiome and immune system development. However, this doesn’t appear to play a major role in the development of food allergy,” she said.
 

The HealthNuts study

In the period 2007-2011, the longitudinal population-based HealthNuts cohort study enrolled 5,276 12-month-olds who underwent skin prick testing and oral food challenge for sensitization to egg, peanut, sesame, and either shellfish or cow’s milk. It linked the resulting data to additional birth statistics from the Victorian Perinatal Data Collection when children turned 6.

Birth data were obtained on 2,045 babies, and in this subgroup with linked data, 30% were born by cesarean – similar to the 31.7% of U.S. cesarean births in 2019 – and 12.7% of these had food allergy versus 13.2% of those delivered vaginally.

Compared with vaginal birth, C-section was not associated with the risk of food allergy (adjusted odds ratio [aOR] 0.95, 95% confidence interval [CI], 0.70-0.30).

Nor did the timing of the C-section have an effect. Cesarean delivery either before labor or after onset of labor was not associated with the risk of food allergy (aOR, 0.83, 95% CI, 0.55-1.23) and aOR, 1.13, 95% CI, 0.75-1.72), respectively.

Compared with vaginal delivery, elective or emergency cesarean was not associated with food allergy risk (aOR, 1.05, 95% CI, 0.71-1.55, and aOR, 0.86, 95% CI, 0.56-1.31).

Similarly, no evidence emerged of an effect modification by breastfeeding, older siblings, pet dog ownership, or maternal allergy.

“This study is helpful because in addition to blood and skin tests, it also used food challenge, which is the gold standard,” Terri Brown-Whitehorn, MD, an attending physician in the division of allergy and immunology at Children’s Hospital of Philadelphia, said in an interview. “If no actual food is given, the other tests could lead to false positives.”

Dr. Brown-Whitehorn, who was not involved in the MCRI research, said the findings are not likely to affect most decisions about C-sections because most are not voluntary. “But if a mother had a first baby by emergency cesarean section, she might be given the option of having the next one by the same method.”

She said the current advice is to introduce even high-risk foods to a child’s diet early on to ward off the development of food allergies.

According to the microbial exposure hypothesis, it was previously thought that a potential link between cesarean birth and allergy might reflect differences in early exposure to maternal flora beneficial to the immune system in the vagina during delivery. A C-section might bypass the opportunity for neonatal gut colonization with maternal gut and vaginal flora, thereby raising allergy risk. A 2018 meta-analysis, for example, suggested cesarean birth could raise the risk for food allergies by 21%.

In other research from HealthNuts, 30% of child peanut allergy and 90% of egg allergy appear to resolve naturally by age 6. These numbers are somewhat higher than what Dr. Brown-Whitehorn sees. “We find that about 20% of peanut allergies and about 70% or 80% – maybe a bit less – of egg allergies resolve by age 6.”

This research was supported by the National Health & Medical Research Council of Australia, the Ilhan Food Allergy Foundation, AnaphylaxiStop, the Charles and Sylvia Viertel Medical Research Foundation, the Victorian Government’s Operational Infrastructure Support Program, and the Melbourne Children’s Clinician-Scientist Fellowship.

Dr. Peters disclosed no competing interests. Several coauthors reported research support or employment with private companies and one is the inventor of an MCRI-held patent. Dr. Brown-Whitehorn had no competing interests to disclose.

Reduced levels of the cholinergic-system enzyme butyrylcholinesterase (BChE) may provide another piece of the puzzle for sudden infant death syndrome (SIDS), preliminary data from Australian researchers suggested.

A small case-control study led by Carmel T. Harrington, PhD,* a sleep medicine expert and honorary research fellow at the Children’s Hospital at Westmead (Australia), found that measurements in 722 dried blood spots taken during neonatal screening 2 or 3 days after birth were lower in babies who subsequently died of SIDS, compared with those of matched surviving controls and other babies who died of non-SIDS causes.

* This story was corrected on 5/20/2022.

Reduced levels of the cholinergic-system enzyme butyrylcholinesterase (BChE) may provide another piece of the puzzle for sudden infant death syndrome (SIDS), preliminary data from Australian researchers suggested.

A small case-control study led by Carmel T. Harrington, PhD,* a sleep medicine expert and honorary research fellow at the Children’s Hospital at Westmead (Australia), found that measurements in 722 dried blood spots taken during neonatal screening 2 or 3 days after birth were lower in babies who subsequently died of SIDS, compared with those of matched surviving controls and other babies who died of non-SIDS causes.

* This story was corrected on 5/20/2022.

Reduced levels of the cholinergic-system enzyme butyrylcholinesterase (BChE) may provide another piece of the puzzle for sudden infant death syndrome (SIDS), preliminary data from Australian researchers suggested.

A small case-control study led by Carmel T. Harrington, PhD,* a sleep medicine expert and honorary research fellow at the Children’s Hospital at Westmead (Australia), found that measurements in 722 dried blood spots taken during neonatal screening 2 or 3 days after birth were lower in babies who subsequently died of SIDS, compared with those of matched surviving controls and other babies who died of non-SIDS causes.

* This story was corrected on 5/20/2022.

Combination therapy with relugolix (Orgovyx, Relumina), a gonadotropin-releasing hormone antagonist, significantly reduced the pain of uterine fibroids, an undertreated aspect of this disease.

In pooled results from the multicenter randomized placebo-controlled LIBERTY 1 and 2 trials, relugolix combination therapy (CT) with the progestin norethindrone (Aygestin, Camila) markedly decreased both menstrual and nonmenstrual fibroid pain, as well as heavy bleeding and other symptoms of leiomyomas. This hormone-dependent condition occurs in 70%-80% of premenopausal women.

“Historically, studies of uterine fibroids have not asked about pain, so one of strengths of these studies is that they asked women to rate their pain and found a substantial proportion listed pain as a symptom,” lead author Elizabeth A. Stewart, MD, director of reproductive endocrinology at the Mayo Clinic in Rochester, Minn., said in an interview.

The combination was effective against all categories of leiomyoma symptoms, she said, and adverse events were few.

Bleeding has been the main focus of studies of leiomyoma therapies, while chronic pain has been largely neglected, said James H. Segars Jr., MD, director of the division of reproductive science and women’s health research at Johns Hopkins Medicine in Baltimore, who was not involved in the studies. Across both of the LIBERTY trials, involving 509 women randomized during the period April 2017 to December 2018, more than half overall (54.4%) met their pain reduction goals in a subpopulation analysis. Pain reduction was a secondary outcome of the trials, with bleeding reduction the primary endpoint. Other fibroid symptoms are abdominal bloating and pressure.

“The consistent and significant reduction in measures of pain with relugolix-CT observed in the LIBERTY program is clinically meaningful, patient-relevant, and together with an improvement of heavy menstrual bleeding and other uterine leiomyoma–associated symptoms, is likely to have a substantial effect on the life of women with symptomatic uterine leiomyomas,” Dr. Stewart and colleagues wrote. Their report was published online in Obstetrics & Gynecology.

Dr. Segars concurred. “This study is important because sometimes the only fibroid symptom women have is pain. If we ignore that, we miss a lot of women who have pain but no bleeding.”
 

The study

The premenopausal participants had a mean age of just over 42 years (range, 18-50) and were enrolled from North and South America, Europe, and Africa. All reported leiomyoma-associated heavy menstrual bleeding of 80 mL or greater per cycle for two cycles, or 160 mL or greater during one cycle.

In both arms, the mean body mass index was 32 kg/m², while menstrual blood loss volume was 245.4 (± 186.4) mL in the relugolix-CT and 207.4 (± 114.3) mL in the placebo group.

Pain was a frequent symptom, with approximately 70% in the intervention group and 74% in the placebo group reporting fibroid pain at baseline.

Women were randomized 1:1:1 to receive:

• Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
• Delayed relugolix-CT (relugolix 40 mg monotherapy followed by relugolix-CT, each for 12 weeks)
• Placebo, taken orally once daily for 24 weeks

The therapy was well tolerated and adverse events were low.

The subpopulation analysis found that over the study period, the proportion of women achieving minimal to no pain (level 0 to 1) during the last 35 days of treatment was notably higher in the relugolix-CT arm than in the placebo arm: 45.2% (95% confidence interval [CI], 36.4%-54.3%) versus 13.9% (95% CI, 8.8%-20.5%) in the placebo group (nominal P = .001).

Moreover, the proportions of women with minimal to no pain during both menstrual days and nonmenstrual days were significantly higher with relugolix-CT: 65.0% (95% CI, 55.6%-73.5%) and 44.6% (95% CI, 32.3%-7.5%), respectively, compared with placebo: 19.3% (95% CI 13.2%–26.7%, nominal P = 001), and 21.6% (95% CI, 12.9%-32.7%, nominal P = 004), respectively.

Studies of relugolix monotherapy in Japanese women with uterine leiomyomas have demonstrated reductions in pain.

“Significantly, this combination therapy allows women to be treated over 2 years and to take the oral tablet themselves, unlike Lupron [leuprolide], which is injected and can only be taken for a couple of months because of bone loss,” Dr. Segars said. And the add-back component of combination therapy prevents the adverse symptoms of a hypoestrogenic state.

“The pain of fibroids is chronic, and the longer treatment allows time for the pain fibers to revert to a normal state,” he explained. “The pain pathways get etched into the nerves and it takes time to revert.”

He noted that the LIBERTY trials showed a slight downward trend in pain continuing after 24 weeks of treatment. Other studies of similar hormonal treatments have shown a reduction in the size of fibroids, which can be as large as a tennis ball.

As in endometriosis, leiomyomas are associated with elevated circulating cytokines and a systemic proinflammatory state. In endometriosis, this milieu is linked to the risk of inflammatory arthritis, fibromyalgia, lupus, and cardiovascular disease, Dr. Segars said. “If we did a deeper dive, we might find the same associations for fibroids.” Apart from chronic depression and fatigue, fibroids are linked to downstream pregnancy complications and poor outcomes such as miscarriage and preterm birth, he said.

“There remains a high unmet need for effective treatments, especially nonsurgical interventions, for women with uterine leiomyomas,” the authors wrote. Dr. Stewart added that “it would be helpful to learn more about how relugolix and other drugs in its class work in fibroids. No category of symptoms has been unresponsive to these medications – they are powerful drugs to help women with uterine fibroids.” She noted that relugolix-CT has already been approved outside the United States for symptoms beyond heavy menstrual bleeding.

Future research should focus on developing a therapy that does not interfere with fertility, Dr. Segars said. “We need a treatment that will allow women to get pregnant on it.”

Myovant Sciences GmbH sponsored LIBERTY 1 and 2 and oversaw all aspects of the studies. Dr. Stewart has provided consulting services to Myovant, Bayer, AbbVie, and ObsEva. She has received royalties from UpToDate and fees from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, as well as honoraria from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. She holds a patent for methods and compounds for treatment of abnormal uterine bleeding. Dr. Segars has consulted for Bayer and Organon. Several coauthors reported similar financial relationships with private-sector entities and two coauthors are employees of Myovant.

Combination therapy with relugolix (Orgovyx, Relumina), a gonadotropin-releasing hormone antagonist, significantly reduced the pain of uterine fibroids, an undertreated aspect of this disease.

In pooled results from the multicenter randomized placebo-controlled LIBERTY 1 and 2 trials, relugolix combination therapy (CT) with the progestin norethindrone (Aygestin, Camila) markedly decreased both menstrual and nonmenstrual fibroid pain, as well as heavy bleeding and other symptoms of leiomyomas. This hormone-dependent condition occurs in 70%-80% of premenopausal women.

“Historically, studies of uterine fibroids have not asked about pain, so one of strengths of these studies is that they asked women to rate their pain and found a substantial proportion listed pain as a symptom,” lead author Elizabeth A. Stewart, MD, director of reproductive endocrinology at the Mayo Clinic in Rochester, Minn., said in an interview.

The combination was effective against all categories of leiomyoma symptoms, she said, and adverse events were few.

Bleeding has been the main focus of studies of leiomyoma therapies, while chronic pain has been largely neglected, said James H. Segars Jr., MD, director of the division of reproductive science and women’s health research at Johns Hopkins Medicine in Baltimore, who was not involved in the studies. Across both of the LIBERTY trials, involving 509 women randomized during the period April 2017 to December 2018, more than half overall (54.4%) met their pain reduction goals in a subpopulation analysis. Pain reduction was a secondary outcome of the trials, with bleeding reduction the primary endpoint. Other fibroid symptoms are abdominal bloating and pressure.

“The consistent and significant reduction in measures of pain with relugolix-CT observed in the LIBERTY program is clinically meaningful, patient-relevant, and together with an improvement of heavy menstrual bleeding and other uterine leiomyoma–associated symptoms, is likely to have a substantial effect on the life of women with symptomatic uterine leiomyomas,” Dr. Stewart and colleagues wrote. Their report was published online in Obstetrics & Gynecology.

Dr. Segars concurred. “This study is important because sometimes the only fibroid symptom women have is pain. If we ignore that, we miss a lot of women who have pain but no bleeding.”
 

The study

The premenopausal participants had a mean age of just over 42 years (range, 18-50) and were enrolled from North and South America, Europe, and Africa. All reported leiomyoma-associated heavy menstrual bleeding of 80 mL or greater per cycle for two cycles, or 160 mL or greater during one cycle.

In both arms, the mean body mass index was 32 kg/m², while menstrual blood loss volume was 245.4 (± 186.4) mL in the relugolix-CT and 207.4 (± 114.3) mL in the placebo group.

Pain was a frequent symptom, with approximately 70% in the intervention group and 74% in the placebo group reporting fibroid pain at baseline.

Women were randomized 1:1:1 to receive:

• Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
• Delayed relugolix-CT (relugolix 40 mg monotherapy followed by relugolix-CT, each for 12 weeks)
• Placebo, taken orally once daily for 24 weeks

The therapy was well tolerated and adverse events were low.

The subpopulation analysis found that over the study period, the proportion of women achieving minimal to no pain (level 0 to 1) during the last 35 days of treatment was notably higher in the relugolix-CT arm than in the placebo arm: 45.2% (95% confidence interval [CI], 36.4%-54.3%) versus 13.9% (95% CI, 8.8%-20.5%) in the placebo group (nominal P = .001).

Moreover, the proportions of women with minimal to no pain during both menstrual days and nonmenstrual days were significantly higher with relugolix-CT: 65.0% (95% CI, 55.6%-73.5%) and 44.6% (95% CI, 32.3%-7.5%), respectively, compared with placebo: 19.3% (95% CI 13.2%–26.7%, nominal P = 001), and 21.6% (95% CI, 12.9%-32.7%, nominal P = 004), respectively.

Studies of relugolix monotherapy in Japanese women with uterine leiomyomas have demonstrated reductions in pain.

“Significantly, this combination therapy allows women to be treated over 2 years and to take the oral tablet themselves, unlike Lupron [leuprolide], which is injected and can only be taken for a couple of months because of bone loss,” Dr. Segars said. And the add-back component of combination therapy prevents the adverse symptoms of a hypoestrogenic state.

“The pain of fibroids is chronic, and the longer treatment allows time for the pain fibers to revert to a normal state,” he explained. “The pain pathways get etched into the nerves and it takes time to revert.”

He noted that the LIBERTY trials showed a slight downward trend in pain continuing after 24 weeks of treatment. Other studies of similar hormonal treatments have shown a reduction in the size of fibroids, which can be as large as a tennis ball.

As in endometriosis, leiomyomas are associated with elevated circulating cytokines and a systemic proinflammatory state. In endometriosis, this milieu is linked to the risk of inflammatory arthritis, fibromyalgia, lupus, and cardiovascular disease, Dr. Segars said. “If we did a deeper dive, we might find the same associations for fibroids.” Apart from chronic depression and fatigue, fibroids are linked to downstream pregnancy complications and poor outcomes such as miscarriage and preterm birth, he said.

“There remains a high unmet need for effective treatments, especially nonsurgical interventions, for women with uterine leiomyomas,” the authors wrote. Dr. Stewart added that “it would be helpful to learn more about how relugolix and other drugs in its class work in fibroids. No category of symptoms has been unresponsive to these medications – they are powerful drugs to help women with uterine fibroids.” She noted that relugolix-CT has already been approved outside the United States for symptoms beyond heavy menstrual bleeding.

Future research should focus on developing a therapy that does not interfere with fertility, Dr. Segars said. “We need a treatment that will allow women to get pregnant on it.”

Myovant Sciences GmbH sponsored LIBERTY 1 and 2 and oversaw all aspects of the studies. Dr. Stewart has provided consulting services to Myovant, Bayer, AbbVie, and ObsEva. She has received royalties from UpToDate and fees from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, as well as honoraria from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. She holds a patent for methods and compounds for treatment of abnormal uterine bleeding. Dr. Segars has consulted for Bayer and Organon. Several coauthors reported similar financial relationships with private-sector entities and two coauthors are employees of Myovant.

Combination therapy with relugolix (Orgovyx, Relumina), a gonadotropin-releasing hormone antagonist, significantly reduced the pain of uterine fibroids, an undertreated aspect of this disease.

In pooled results from the multicenter randomized placebo-controlled LIBERTY 1 and 2 trials, relugolix combination therapy (CT) with the progestin norethindrone (Aygestin, Camila) markedly decreased both menstrual and nonmenstrual fibroid pain, as well as heavy bleeding and other symptoms of leiomyomas. This hormone-dependent condition occurs in 70%-80% of premenopausal women.

“Historically, studies of uterine fibroids have not asked about pain, so one of strengths of these studies is that they asked women to rate their pain and found a substantial proportion listed pain as a symptom,” lead author Elizabeth A. Stewart, MD, director of reproductive endocrinology at the Mayo Clinic in Rochester, Minn., said in an interview.

The combination was effective against all categories of leiomyoma symptoms, she said, and adverse events were few.

Bleeding has been the main focus of studies of leiomyoma therapies, while chronic pain has been largely neglected, said James H. Segars Jr., MD, director of the division of reproductive science and women’s health research at Johns Hopkins Medicine in Baltimore, who was not involved in the studies. Across both of the LIBERTY trials, involving 509 women randomized during the period April 2017 to December 2018, more than half overall (54.4%) met their pain reduction goals in a subpopulation analysis. Pain reduction was a secondary outcome of the trials, with bleeding reduction the primary endpoint. Other fibroid symptoms are abdominal bloating and pressure.

“The consistent and significant reduction in measures of pain with relugolix-CT observed in the LIBERTY program is clinically meaningful, patient-relevant, and together with an improvement of heavy menstrual bleeding and other uterine leiomyoma–associated symptoms, is likely to have a substantial effect on the life of women with symptomatic uterine leiomyomas,” Dr. Stewart and colleagues wrote. Their report was published online in Obstetrics & Gynecology.

Dr. Segars concurred. “This study is important because sometimes the only fibroid symptom women have is pain. If we ignore that, we miss a lot of women who have pain but no bleeding.”
 

The study

The premenopausal participants had a mean age of just over 42 years (range, 18-50) and were enrolled from North and South America, Europe, and Africa. All reported leiomyoma-associated heavy menstrual bleeding of 80 mL or greater per cycle for two cycles, or 160 mL or greater during one cycle.

In both arms, the mean body mass index was 32 kg/m², while menstrual blood loss volume was 245.4 (± 186.4) mL in the relugolix-CT and 207.4 (± 114.3) mL in the placebo group.

Pain was a frequent symptom, with approximately 70% in the intervention group and 74% in the placebo group reporting fibroid pain at baseline.

Women were randomized 1:1:1 to receive:

• Relugolix-CT (relugolix 40 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
• Delayed relugolix-CT (relugolix 40 mg monotherapy followed by relugolix-CT, each for 12 weeks)
• Placebo, taken orally once daily for 24 weeks

The therapy was well tolerated and adverse events were low.

The subpopulation analysis found that over the study period, the proportion of women achieving minimal to no pain (level 0 to 1) during the last 35 days of treatment was notably higher in the relugolix-CT arm than in the placebo arm: 45.2% (95% confidence interval [CI], 36.4%-54.3%) versus 13.9% (95% CI, 8.8%-20.5%) in the placebo group (nominal P = .001).

Moreover, the proportions of women with minimal to no pain during both menstrual days and nonmenstrual days were significantly higher with relugolix-CT: 65.0% (95% CI, 55.6%-73.5%) and 44.6% (95% CI, 32.3%-7.5%), respectively, compared with placebo: 19.3% (95% CI 13.2%–26.7%, nominal P = 001), and 21.6% (95% CI, 12.9%-32.7%, nominal P = 004), respectively.

Studies of relugolix monotherapy in Japanese women with uterine leiomyomas have demonstrated reductions in pain.

“Significantly, this combination therapy allows women to be treated over 2 years and to take the oral tablet themselves, unlike Lupron [leuprolide], which is injected and can only be taken for a couple of months because of bone loss,” Dr. Segars said. And the add-back component of combination therapy prevents the adverse symptoms of a hypoestrogenic state.

“The pain of fibroids is chronic, and the longer treatment allows time for the pain fibers to revert to a normal state,” he explained. “The pain pathways get etched into the nerves and it takes time to revert.”

He noted that the LIBERTY trials showed a slight downward trend in pain continuing after 24 weeks of treatment. Other studies of similar hormonal treatments have shown a reduction in the size of fibroids, which can be as large as a tennis ball.

As in endometriosis, leiomyomas are associated with elevated circulating cytokines and a systemic proinflammatory state. In endometriosis, this milieu is linked to the risk of inflammatory arthritis, fibromyalgia, lupus, and cardiovascular disease, Dr. Segars said. “If we did a deeper dive, we might find the same associations for fibroids.” Apart from chronic depression and fatigue, fibroids are linked to downstream pregnancy complications and poor outcomes such as miscarriage and preterm birth, he said.

“There remains a high unmet need for effective treatments, especially nonsurgical interventions, for women with uterine leiomyomas,” the authors wrote. Dr. Stewart added that “it would be helpful to learn more about how relugolix and other drugs in its class work in fibroids. No category of symptoms has been unresponsive to these medications – they are powerful drugs to help women with uterine fibroids.” She noted that relugolix-CT has already been approved outside the United States for symptoms beyond heavy menstrual bleeding.

Future research should focus on developing a therapy that does not interfere with fertility, Dr. Segars said. “We need a treatment that will allow women to get pregnant on it.”

Myovant Sciences GmbH sponsored LIBERTY 1 and 2 and oversaw all aspects of the studies. Dr. Stewart has provided consulting services to Myovant, Bayer, AbbVie, and ObsEva. She has received royalties from UpToDate and fees from Med Learning Group, Med-IQ, Medscape, Peer View, and PER, as well as honoraria from the American College of Obstetricians and Gynecologists and Massachusetts Medical Society. She holds a patent for methods and compounds for treatment of abnormal uterine bleeding. Dr. Segars has consulted for Bayer and Organon. Several coauthors reported similar financial relationships with private-sector entities and two coauthors are employees of Myovant.

With more families placing their children on vegetarian diets, the results from a Canadian longitudinal cohort study are reassuring: It found no clinically meaningful differences in height, growth, or biochemical measures of nutrition in young children on vegetarian and nonvegetarian diets.

While z scores (the standard deviation above or below the mean) were similar in both dietary groups, there was a weak association between a vegetarian diet and lower mean z height, as well as slightly higher odds of underweight.

No significant associations were identified between vegetarian and nonvegetarian diets for child z body mass index (BMI), serum ferritin, 25(OH)D, and serum lipids, according to Jonathon L. Maguire, MD. MSc, of St. Michael’s Hospital Pediatric Clinic in Toronto.

Moreover, the magnitude of the height and vegetarian diet association was small at just 0.3 cm for a 3-year-old child and unlikely to be clinically meaningful, Dr. Maguire and colleagues wrote online in Pediatrics.

In a secondary study outcome, cow’s milk consumption was associated with higher serum lipid levels for both diets. Serum lipids were similar among those who did or did not consume a vegetarian diet and consumed the recommended 2 cups of cow’s milk per day.

“The vast majority of children with vegetarian diets have similar growth and nutrition as children without vegetarian diets,” said Dr. Maguire, who is also a professor of pediatrics and nutritional sciences at the University of Toronto, in an interview. “But, I think we should be mindful to carefully plan vegetarian diets for children [who are] underweight.”

The study conclusion was based on 8,907 children, 6 months to 8 years of age, including 248 vegetarian and 25 vegan children, at baseline. They were part of theTARGet Kids! practice-based research network in Toronto.

The mean age of children at baseline was 2.2 years (standard deviation, 1.5), and 52.4% were male. Participants were followed for an average of 2.8 years (SD, 1.7).

Those with a vegetarian diet had longer breastfeeding duration: 12.6 months (SD, 9.5) versus 10.0 months (SD, 7.0). They were also more likely to be of Asian ethnicity: 33.8% versus 19.0%. Otherwise, children with and without a vegetarian diet were similar at baseline.

In study outcomes, vegetarian children had higher odds of underweight: body mass index z score less than –2 (odds ratio 1.87; 95% confidence interval, 1.19-2.96, P = .007), while no association with overweight or obesity was found.

In a secondary outcome, cow’s milk consumption was associated with higher levels of non–high-density lipoprotein cholesterol (P = .03), total cholesterol (P = .04), and low-density lipoprotein cholesterol (P = .02) in young children on a vegetarian diet. Levels were similar in children with and without a vegetarian diet who consumed the recommended 2 cups of cow’s milk per day.

Previous studies have found that vegetarian children have normal growth and development but tend to be leaner than their omnivore peers.

As for the potential effect of following a fully vegan diet on these nutritional measures, Dr. Maguire said, “Unfortunately, there were not enough children with vegan diets to make meaningful conclusions.”

Would results likely be similar in older children who have more independence and engage more with their peers?“ I don’t know, but we will be following these children for many years to come through the TARGet Kids! research network, Dr. Maguire said.

Studies such as this are timely as plant-based eating becomes more widespread in the United States. The 2007-2010 National Health and Nutrition Examination Surveys found that 2.1% of American adults followed a vegetarian diet, and that figure appears to have increased, with 5% of American adults self-identifying as vegetarian in a 2019 Gallup poll.

Offering her perspective on the Canadian study but not involved in it, Stephanie Di Figlia-Peck, MS, RDN, agreed the results indicate that “a vegetarian diet is not a negative thing for growth and development.” She is a lead registered dietitian in the division of adolescent medicine at Cohen Children’s Medical Center in New Hyde Park, N.Y. She noted, however, that the study looked only at very young children on average.

She stressed that vegetarian regimens require family commitment and agreed on the need for planning. “For these diets to work, a lot has to go into it. But if they’re carefully planned, there is adequate protein and micro- and macronutrients and there’s a nonnegative effect on growth and development.”

The study results mirror what she sees in clinical practice, with vegetarian children tending to weigh less. “Some obese and overweight children will adopt vegetarian diets to lose weight,” Ms. Di Figlia-Peck said.

And perseverance has rewards. “When people follow a vegetarian diet, they tend to have lower blood pressure and cholesterol. A plant-based diet can favorably impact diseases for an entire lifetime.”

This study was supported by the Canadian Institutes of Health Research and the St. Michael’s Hospital and SickKids Hospital foundations. Dr. Maguire received an unrestricted research grant for a previous investigator-initiated study from Dairy Farmers of Canada, and D drops provided nonfinancial support (vitamin D supplements) for a previous investigator-initiated study on vitamin D and respiratory tract infections. Coauthor David Jenkins, MD, PhD, DSc, reported research support from multiple private-sector and nonprivate organizations; several of his family members are involved in the promotion of vegetarian diets. Ms. Di Figlia-Peck had no competing interests to declare.

With more families placing their children on vegetarian diets, the results from a Canadian longitudinal cohort study are reassuring: It found no clinically meaningful differences in height, growth, or biochemical measures of nutrition in young children on vegetarian and nonvegetarian diets.

While z scores (the standard deviation above or below the mean) were similar in both dietary groups, there was a weak association between a vegetarian diet and lower mean z height, as well as slightly higher odds of underweight.

No significant associations were identified between vegetarian and nonvegetarian diets for child z body mass index (BMI), serum ferritin, 25(OH)D, and serum lipids, according to Jonathon L. Maguire, MD. MSc, of St. Michael’s Hospital Pediatric Clinic in Toronto.

Moreover, the magnitude of the height and vegetarian diet association was small at just 0.3 cm for a 3-year-old child and unlikely to be clinically meaningful, Dr. Maguire and colleagues wrote online in Pediatrics.

In a secondary study outcome, cow’s milk consumption was associated with higher serum lipid levels for both diets. Serum lipids were similar among those who did or did not consume a vegetarian diet and consumed the recommended 2 cups of cow’s milk per day.

“The vast majority of children with vegetarian diets have similar growth and nutrition as children without vegetarian diets,” said Dr. Maguire, who is also a professor of pediatrics and nutritional sciences at the University of Toronto, in an interview. “But, I think we should be mindful to carefully plan vegetarian diets for children [who are] underweight.”

The study conclusion was based on 8,907 children, 6 months to 8 years of age, including 248 vegetarian and 25 vegan children, at baseline. They were part of theTARGet Kids! practice-based research network in Toronto.

The mean age of children at baseline was 2.2 years (standard deviation, 1.5), and 52.4% were male. Participants were followed for an average of 2.8 years (SD, 1.7).

Those with a vegetarian diet had longer breastfeeding duration: 12.6 months (SD, 9.5) versus 10.0 months (SD, 7.0). They were also more likely to be of Asian ethnicity: 33.8% versus 19.0%. Otherwise, children with and without a vegetarian diet were similar at baseline.

In study outcomes, vegetarian children had higher odds of underweight: body mass index z score less than –2 (odds ratio 1.87; 95% confidence interval, 1.19-2.96, P = .007), while no association with overweight or obesity was found.

In a secondary outcome, cow’s milk consumption was associated with higher levels of non–high-density lipoprotein cholesterol (P = .03), total cholesterol (P = .04), and low-density lipoprotein cholesterol (P = .02) in young children on a vegetarian diet. Levels were similar in children with and without a vegetarian diet who consumed the recommended 2 cups of cow’s milk per day.

Previous studies have found that vegetarian children have normal growth and development but tend to be leaner than their omnivore peers.

As for the potential effect of following a fully vegan diet on these nutritional measures, Dr. Maguire said, “Unfortunately, there were not enough children with vegan diets to make meaningful conclusions.”

Would results likely be similar in older children who have more independence and engage more with their peers?“ I don’t know, but we will be following these children for many years to come through the TARGet Kids! research network, Dr. Maguire said.

Studies such as this are timely as plant-based eating becomes more widespread in the United States. The 2007-2010 National Health and Nutrition Examination Surveys found that 2.1% of American adults followed a vegetarian diet, and that figure appears to have increased, with 5% of American adults self-identifying as vegetarian in a 2019 Gallup poll.

Offering her perspective on the Canadian study but not involved in it, Stephanie Di Figlia-Peck, MS, RDN, agreed the results indicate that “a vegetarian diet is not a negative thing for growth and development.” She is a lead registered dietitian in the division of adolescent medicine at Cohen Children’s Medical Center in New Hyde Park, N.Y. She noted, however, that the study looked only at very young children on average.

She stressed that vegetarian regimens require family commitment and agreed on the need for planning. “For these diets to work, a lot has to go into it. But if they’re carefully planned, there is adequate protein and micro- and macronutrients and there’s a nonnegative effect on growth and development.”

The study results mirror what she sees in clinical practice, with vegetarian children tending to weigh less. “Some obese and overweight children will adopt vegetarian diets to lose weight,” Ms. Di Figlia-Peck said.

And perseverance has rewards. “When people follow a vegetarian diet, they tend to have lower blood pressure and cholesterol. A plant-based diet can favorably impact diseases for an entire lifetime.”

This study was supported by the Canadian Institutes of Health Research and the St. Michael’s Hospital and SickKids Hospital foundations. Dr. Maguire received an unrestricted research grant for a previous investigator-initiated study from Dairy Farmers of Canada, and D drops provided nonfinancial support (vitamin D supplements) for a previous investigator-initiated study on vitamin D and respiratory tract infections. Coauthor David Jenkins, MD, PhD, DSc, reported research support from multiple private-sector and nonprivate organizations; several of his family members are involved in the promotion of vegetarian diets. Ms. Di Figlia-Peck had no competing interests to declare.

With more families placing their children on vegetarian diets, the results from a Canadian longitudinal cohort study are reassuring: It found no clinically meaningful differences in height, growth, or biochemical measures of nutrition in young children on vegetarian and nonvegetarian diets.

While z scores (the standard deviation above or below the mean) were similar in both dietary groups, there was a weak association between a vegetarian diet and lower mean z height, as well as slightly higher odds of underweight.

No significant associations were identified between vegetarian and nonvegetarian diets for child z body mass index (BMI), serum ferritin, 25(OH)D, and serum lipids, according to Jonathon L. Maguire, MD. MSc, of St. Michael’s Hospital Pediatric Clinic in Toronto.

Moreover, the magnitude of the height and vegetarian diet association was small at just 0.3 cm for a 3-year-old child and unlikely to be clinically meaningful, Dr. Maguire and colleagues wrote online in Pediatrics.

In a secondary study outcome, cow’s milk consumption was associated with higher serum lipid levels for both diets. Serum lipids were similar among those who did or did not consume a vegetarian diet and consumed the recommended 2 cups of cow’s milk per day.

“The vast majority of children with vegetarian diets have similar growth and nutrition as children without vegetarian diets,” said Dr. Maguire, who is also a professor of pediatrics and nutritional sciences at the University of Toronto, in an interview. “But, I think we should be mindful to carefully plan vegetarian diets for children [who are] underweight.”

The study conclusion was based on 8,907 children, 6 months to 8 years of age, including 248 vegetarian and 25 vegan children, at baseline. They were part of theTARGet Kids! practice-based research network in Toronto.

The mean age of children at baseline was 2.2 years (standard deviation, 1.5), and 52.4% were male. Participants were followed for an average of 2.8 years (SD, 1.7).

Those with a vegetarian diet had longer breastfeeding duration: 12.6 months (SD, 9.5) versus 10.0 months (SD, 7.0). They were also more likely to be of Asian ethnicity: 33.8% versus 19.0%. Otherwise, children with and without a vegetarian diet were similar at baseline.

In study outcomes, vegetarian children had higher odds of underweight: body mass index z score less than –2 (odds ratio 1.87; 95% confidence interval, 1.19-2.96, P = .007), while no association with overweight or obesity was found.

In a secondary outcome, cow’s milk consumption was associated with higher levels of non–high-density lipoprotein cholesterol (P = .03), total cholesterol (P = .04), and low-density lipoprotein cholesterol (P = .02) in young children on a vegetarian diet. Levels were similar in children with and without a vegetarian diet who consumed the recommended 2 cups of cow’s milk per day.

Previous studies have found that vegetarian children have normal growth and development but tend to be leaner than their omnivore peers.

As for the potential effect of following a fully vegan diet on these nutritional measures, Dr. Maguire said, “Unfortunately, there were not enough children with vegan diets to make meaningful conclusions.”

Would results likely be similar in older children who have more independence and engage more with their peers?“ I don’t know, but we will be following these children for many years to come through the TARGet Kids! research network, Dr. Maguire said.

Studies such as this are timely as plant-based eating becomes more widespread in the United States. The 2007-2010 National Health and Nutrition Examination Surveys found that 2.1% of American adults followed a vegetarian diet, and that figure appears to have increased, with 5% of American adults self-identifying as vegetarian in a 2019 Gallup poll.

Offering her perspective on the Canadian study but not involved in it, Stephanie Di Figlia-Peck, MS, RDN, agreed the results indicate that “a vegetarian diet is not a negative thing for growth and development.” She is a lead registered dietitian in the division of adolescent medicine at Cohen Children’s Medical Center in New Hyde Park, N.Y. She noted, however, that the study looked only at very young children on average.

She stressed that vegetarian regimens require family commitment and agreed on the need for planning. “For these diets to work, a lot has to go into it. But if they’re carefully planned, there is adequate protein and micro- and macronutrients and there’s a nonnegative effect on growth and development.”

The study results mirror what she sees in clinical practice, with vegetarian children tending to weigh less. “Some obese and overweight children will adopt vegetarian diets to lose weight,” Ms. Di Figlia-Peck said.

And perseverance has rewards. “When people follow a vegetarian diet, they tend to have lower blood pressure and cholesterol. A plant-based diet can favorably impact diseases for an entire lifetime.”

This study was supported by the Canadian Institutes of Health Research and the St. Michael’s Hospital and SickKids Hospital foundations. Dr. Maguire received an unrestricted research grant for a previous investigator-initiated study from Dairy Farmers of Canada, and D drops provided nonfinancial support (vitamin D supplements) for a previous investigator-initiated study on vitamin D and respiratory tract infections. Coauthor David Jenkins, MD, PhD, DSc, reported research support from multiple private-sector and nonprivate organizations; several of his family members are involved in the promotion of vegetarian diets. Ms. Di Figlia-Peck had no competing interests to declare.

A 12-week hypocaloric diet provided suitable control of joint disease activity in patients with psoriatic arthritis (PsA), regardless of weight loss, Brazilian researchers found.

Earlier research has reported that weight loss improves the symptoms of PsA.

Improvement in the Brazilian DIETA study was linked to both better eating patterns and better quality of diet, and while omega-3 supplementation caused relevant body composition changes, it did not improve disease activity, according to Beatriz F. Leite of the division of rheumatology at the Federal University of São Paulo and colleagues.

“The DIETA trial, a nonpharmacologic approach, is an inexpensive, suitable, and efficient approach that could be combined with standardized drug therapy,” the investigators wrote online in Advances in Rheumatology.

Dietary counseling aimed at losing or controlling weight could therefore be part of the global protocol for PsA patients, the researchers added. They conceded, however, that nonpharmacologic interventions traditionally have a low rate of adherence.

This recommendation aligns with a systematic review by the National Psoriasis Foundation, which found evidence of benefit with dietary weight reduction via a hypocaloric diet in overweight and obese patients with psoriasis and/or PsA. 
 

The DIETA trial

The 12-week randomized, double-blind, placebo-controlled study, conducted at three hospitals in São Paulo from September 2012 to May 2014, assessed whether dietary changes, antioxidant supplementation, or weight loss of 5%-10% could improve skin and joint activity in 97 enrolled PsA patients.

Participants were randomized into the following supervised dietary groups:

• Diet-placebo (hypocaloric diet plus placebo supplementation).
• Diet-fish (hypocaloric diet plus 3 g/day of omega-3 supplementation).
• Placebo (with habitual diet).

Diets were carefully tailored to each individual patient. The regimen for overweight and obese patients included a 500-kcal restriction, while for eutrophic patients, diets were calculated to maintain weight with no caloric restriction.

In the 91 patients evaluable by multiple measures at 12 weeks, Ms. Leite and colleagues observed the following:

• The Disease Activity Score 28 (DAS28) for Rheumatoid Arthritis with C-Reactive Protein and the Bath Ankylosing Spondylitis Disease Activity Index improved, especially in the diet-placebo group (−0.6 ± 0.9, P = .004 and −1.39 ± 1.97, P = .001, respectively).
• Minimal disease activity improved in all groups.
• The diet-fish group showed significant weight loss (−1.79 ± 2.4 kg, P = .004), as well as reductions in waist circumference (−3.28 ± 3.5 cm, P < .001) and body fat (−1.2 ± 2.2 kg, P = .006).

Other findings from this study showed the following:

• No significant correlation was seen between weight loss and disease activity improvement.
• Each 1-unit increase in the Healthy Eating Index value reduced the likelihood of achieving remission by 4%.
• Each 100-calorie increase per day caused a 3.4-fold impairment on the DAS28-Erythrocyte Sedimentation Rate score.

The fact that no changes in PsA, medications, or physical activity were made during the study period reinforces the role of diet in the context of immunometabolism, the authors said. Supervised exercise, however, could contribute to weight loss, lean muscle mass, and better disease activity control.

The authors stressed that the data suggest “increased energy intake and worse diet quality may negatively affect joint activity and reduce the likelihood of achieving disease remission, regardless of weight loss or body composition changes.”

“There are other studies that have looked at the effect of weight loss from a very low-calorie diet, and they’ve suggested that PsA symptoms can improve, said rheumatologist Eric. M. Ruderman, MD, a professor of medicine at Northwestern Medicine in Chicago, in an interview. “The unique piece here is that they found that the improvement was really independent of weight loss.”

Dr. Ruderman, who was not involved in DIETA, cautioned, however, that the study is small and saw improvement in the placebo group as well, which could suggest that some of the improvement was related to the extra attention and regular communication with the nutritionist that came with participation in the study.

“Also, the absolute improvement was small, and the dietary restriction was pretty aggressive, so I’m not sure how generalizable this really is. While there are lots of benefits to maintaining a healthy diet and exercising, I don’t think that the results of this small study would justify taking an aggressive [dietary] approach as part of the clinical playbook for all PsA patients.”

This study was supported by the São Paulo Research Foundation and the Coordination for Improvement in Higher Education Foundation of the Ministry of Education, Brazil.

The authors had no competing interests to declare.

Dr. Ruderman disclosed no relevant competing interests.
 

A 12-week hypocaloric diet provided suitable control of joint disease activity in patients with psoriatic arthritis (PsA), regardless of weight loss, Brazilian researchers found.

Earlier research has reported that weight loss improves the symptoms of PsA.

Improvement in the Brazilian DIETA study was linked to both better eating patterns and better quality of diet, and while omega-3 supplementation caused relevant body composition changes, it did not improve disease activity, according to Beatriz F. Leite of the division of rheumatology at the Federal University of São Paulo and colleagues.

“The DIETA trial, a nonpharmacologic approach, is an inexpensive, suitable, and efficient approach that could be combined with standardized drug therapy,” the investigators wrote online in Advances in Rheumatology.

Dietary counseling aimed at losing or controlling weight could therefore be part of the global protocol for PsA patients, the researchers added. They conceded, however, that nonpharmacologic interventions traditionally have a low rate of adherence.

This recommendation aligns with a systematic review by the National Psoriasis Foundation, which found evidence of benefit with dietary weight reduction via a hypocaloric diet in overweight and obese patients with psoriasis and/or PsA. 
 

The DIETA trial

The 12-week randomized, double-blind, placebo-controlled study, conducted at three hospitals in São Paulo from September 2012 to May 2014, assessed whether dietary changes, antioxidant supplementation, or weight loss of 5%-10% could improve skin and joint activity in 97 enrolled PsA patients.

Participants were randomized into the following supervised dietary groups:

• Diet-placebo (hypocaloric diet plus placebo supplementation).
• Diet-fish (hypocaloric diet plus 3 g/day of omega-3 supplementation).
• Placebo (with habitual diet).

Diets were carefully tailored to each individual patient. The regimen for overweight and obese patients included a 500-kcal restriction, while for eutrophic patients, diets were calculated to maintain weight with no caloric restriction.

In the 91 patients evaluable by multiple measures at 12 weeks, Ms. Leite and colleagues observed the following:

• The Disease Activity Score 28 (DAS28) for Rheumatoid Arthritis with C-Reactive Protein and the Bath Ankylosing Spondylitis Disease Activity Index improved, especially in the diet-placebo group (−0.6 ± 0.9, P = .004 and −1.39 ± 1.97, P = .001, respectively).
• Minimal disease activity improved in all groups.
• The diet-fish group showed significant weight loss (−1.79 ± 2.4 kg, P = .004), as well as reductions in waist circumference (−3.28 ± 3.5 cm, P < .001) and body fat (−1.2 ± 2.2 kg, P = .006).

Other findings from this study showed the following:

• No significant correlation was seen between weight loss and disease activity improvement.
• Each 1-unit increase in the Healthy Eating Index value reduced the likelihood of achieving remission by 4%.
• Each 100-calorie increase per day caused a 3.4-fold impairment on the DAS28-Erythrocyte Sedimentation Rate score.

The fact that no changes in PsA, medications, or physical activity were made during the study period reinforces the role of diet in the context of immunometabolism, the authors said. Supervised exercise, however, could contribute to weight loss, lean muscle mass, and better disease activity control.

The authors stressed that the data suggest “increased energy intake and worse diet quality may negatively affect joint activity and reduce the likelihood of achieving disease remission, regardless of weight loss or body composition changes.”

“There are other studies that have looked at the effect of weight loss from a very low-calorie diet, and they’ve suggested that PsA symptoms can improve, said rheumatologist Eric. M. Ruderman, MD, a professor of medicine at Northwestern Medicine in Chicago, in an interview. “The unique piece here is that they found that the improvement was really independent of weight loss.”

Dr. Ruderman, who was not involved in DIETA, cautioned, however, that the study is small and saw improvement in the placebo group as well, which could suggest that some of the improvement was related to the extra attention and regular communication with the nutritionist that came with participation in the study.

“Also, the absolute improvement was small, and the dietary restriction was pretty aggressive, so I’m not sure how generalizable this really is. While there are lots of benefits to maintaining a healthy diet and exercising, I don’t think that the results of this small study would justify taking an aggressive [dietary] approach as part of the clinical playbook for all PsA patients.”

This study was supported by the São Paulo Research Foundation and the Coordination for Improvement in Higher Education Foundation of the Ministry of Education, Brazil.

The authors had no competing interests to declare.

Dr. Ruderman disclosed no relevant competing interests.
 

A 12-week hypocaloric diet provided suitable control of joint disease activity in patients with psoriatic arthritis (PsA), regardless of weight loss, Brazilian researchers found.

Earlier research has reported that weight loss improves the symptoms of PsA.

Improvement in the Brazilian DIETA study was linked to both better eating patterns and better quality of diet, and while omega-3 supplementation caused relevant body composition changes, it did not improve disease activity, according to Beatriz F. Leite of the division of rheumatology at the Federal University of São Paulo and colleagues.

“The DIETA trial, a nonpharmacologic approach, is an inexpensive, suitable, and efficient approach that could be combined with standardized drug therapy,” the investigators wrote online in Advances in Rheumatology.

Dietary counseling aimed at losing or controlling weight could therefore be part of the global protocol for PsA patients, the researchers added. They conceded, however, that nonpharmacologic interventions traditionally have a low rate of adherence.

This recommendation aligns with a systematic review by the National Psoriasis Foundation, which found evidence of benefit with dietary weight reduction via a hypocaloric diet in overweight and obese patients with psoriasis and/or PsA. 
 

The DIETA trial

The 12-week randomized, double-blind, placebo-controlled study, conducted at three hospitals in São Paulo from September 2012 to May 2014, assessed whether dietary changes, antioxidant supplementation, or weight loss of 5%-10% could improve skin and joint activity in 97 enrolled PsA patients.

Participants were randomized into the following supervised dietary groups:

• Diet-placebo (hypocaloric diet plus placebo supplementation).
• Diet-fish (hypocaloric diet plus 3 g/day of omega-3 supplementation).
• Placebo (with habitual diet).

Diets were carefully tailored to each individual patient. The regimen for overweight and obese patients included a 500-kcal restriction, while for eutrophic patients, diets were calculated to maintain weight with no caloric restriction.

In the 91 patients evaluable by multiple measures at 12 weeks, Ms. Leite and colleagues observed the following:

• The Disease Activity Score 28 (DAS28) for Rheumatoid Arthritis with C-Reactive Protein and the Bath Ankylosing Spondylitis Disease Activity Index improved, especially in the diet-placebo group (−0.6 ± 0.9, P = .004 and −1.39 ± 1.97, P = .001, respectively).
• Minimal disease activity improved in all groups.
• The diet-fish group showed significant weight loss (−1.79 ± 2.4 kg, P = .004), as well as reductions in waist circumference (−3.28 ± 3.5 cm, P < .001) and body fat (−1.2 ± 2.2 kg, P = .006).

Other findings from this study showed the following:

• No significant correlation was seen between weight loss and disease activity improvement.
• Each 1-unit increase in the Healthy Eating Index value reduced the likelihood of achieving remission by 4%.
• Each 100-calorie increase per day caused a 3.4-fold impairment on the DAS28-Erythrocyte Sedimentation Rate score.

The fact that no changes in PsA, medications, or physical activity were made during the study period reinforces the role of diet in the context of immunometabolism, the authors said. Supervised exercise, however, could contribute to weight loss, lean muscle mass, and better disease activity control.

The authors stressed that the data suggest “increased energy intake and worse diet quality may negatively affect joint activity and reduce the likelihood of achieving disease remission, regardless of weight loss or body composition changes.”

“There are other studies that have looked at the effect of weight loss from a very low-calorie diet, and they’ve suggested that PsA symptoms can improve, said rheumatologist Eric. M. Ruderman, MD, a professor of medicine at Northwestern Medicine in Chicago, in an interview. “The unique piece here is that they found that the improvement was really independent of weight loss.”

Dr. Ruderman, who was not involved in DIETA, cautioned, however, that the study is small and saw improvement in the placebo group as well, which could suggest that some of the improvement was related to the extra attention and regular communication with the nutritionist that came with participation in the study.

“Also, the absolute improvement was small, and the dietary restriction was pretty aggressive, so I’m not sure how generalizable this really is. While there are lots of benefits to maintaining a healthy diet and exercising, I don’t think that the results of this small study would justify taking an aggressive [dietary] approach as part of the clinical playbook for all PsA patients.”

This study was supported by the São Paulo Research Foundation and the Coordination for Improvement in Higher Education Foundation of the Ministry of Education, Brazil.

The authors had no competing interests to declare.

Dr. Ruderman disclosed no relevant competing interests.
 

Despite the availability of effective direct-acting antivirals, very few a mothers with opioid use disorder (OUD) and hepatitis C virus (HCV) during pregnancy received follow-up care or treatment for the infection within 6 months of giving birth, a retrospective study of Medicaid maternity patients found.

The study pooled data on 23,780 Medicaid-enrolled pregnant women with OUD who had a live or stillbirth during 2016-2019 and were followed for 6 months after delivery. Among these women – drawn from six states in the Medicaid Outcomes Distributed Research Network – the pooled average probability of HCV testing during pregnancy was 70.3% (95% confidence interval, 61.5%-79.1%). Of these, 30.9% (95% CI, 23.8%-38%) tested positive. At 60 days postpartum, just 3.2% (95% CI, 2.6%-3.8%) had a follow-up visit or treatment for HCV. In a subset of patients followed for 6 months, only 5.9% (95% CI, 4.9%-6.9%) had any HCV follow-up visit or medication within 6 months of delivery.

While HCV screening and diagnosis rates varied across states, postpartum follow-up rates were universally low. The results suggest a need to improve the cascade of postpartum care for HCV and, ultimately perhaps, introduce antenatal HCV treatment, as is currently given safely for HIV, if current clinical research establishes safety, according to Marian P. Jarlenski, PhD, MPH, an associate professor of public health policy and management at the University of Pittsburgh. The study was published in Obstetrics & Gynecology.

HCV infection has risen substantially in people of reproductive age in tandem with an increase in OUDs. HCV is transmitted from an infected mother to her baby in about 6% of cases, according to the Centers for Disease Control and Prevention, which in 2020 expanded its HCV screening recommendations to include all pregnant women. Currently no treatment for HCV during pregnancy has been approved.

In light of those recent recommendations, Dr. Jarlenski said in an interview that her group was “interested in looking at high-risk screened people and estimating what proportion received follow-up care and treatment for HCV. What is the promise of screening? The promise is that you can treat. Otherwise why screen?”

She acknowledged, however, that the postpartum period is a challenging time for a mother to seek health information or care for herself, whether she’s a new parent or has other children in the home. Nevertheless, the low rate of follow-up and treatment was unexpected. “Even the 70% rate of screening was low – we felt it should have been closer to 100% – but the follow-up rate was surprisingly low,” Dr. Jarlenski said.

Mishka Terplan, MD, MPH, medical director of Friends Research Institute in Baltimore, was not surprised at the low follow-up rate. “The cascade of care for hep C is demoralizing,” said Dr. Terplan, who was not involved in the study. “We know that hep C is syndemic with OUD and other opioid crises and we know that screening is effective for identifying hep C and that antiviral medications are now more effective and less toxic than ever before. But despite this, we’re failing pregnant women and their kids at every step along the cascade. We do a better job with initial testing than with the follow-up testing. We do a horrible job with postpartum medication initiation.”

He pointed to the systemic challenges mothers face in getting postpartum HCV care. “They may be transferred to a subspecialist for treatment, and this transfer is compounded by issues of insurance coverage and eligibility.” With the onus on new mothers to submit the paperwork, “the idea that mothers would be able to initiate much less continue postpartum treatment is absurd,” Dr. Terplan said.

He added that the children born to HCV-positive mothers need surveillance as well, but data suggest that the rates of newborn testing are also low. “There’s a preventable public health burden in all of this.”

The obvious way to increase eradicative therapy would be to treat women while they are getting antenatal care. A small phase 1 trial found that all pregnant participants who were HCV positive and given antivirals in their second trimester were safely treated and gave birth to healthy babies.

“If larger trials prove this treatment is safe and effective, then these results should be communicated to care providers and pregnant patients,” Dr. Jarlenski said. Otherwise, the public health potential of universal screening in pregnancy will not be realized.

This research was supported by the National Institute of Drug Abuse and by the Delaware Division of Medicaid and Medical Assistance and the University of Delaware, Center for Community Research & Service. Dr. Jarlenski disclosed no competing interests. One coauthor disclosed grant funding through her institution from Gilead Sciences and Organon unrelated to this work. Dr. Terplan reported no relevant competing interests.

Despite the availability of effective direct-acting antivirals, very few a mothers with opioid use disorder (OUD) and hepatitis C virus (HCV) during pregnancy received follow-up care or treatment for the infection within 6 months of giving birth, a retrospective study of Medicaid maternity patients found.

The study pooled data on 23,780 Medicaid-enrolled pregnant women with OUD who had a live or stillbirth during 2016-2019 and were followed for 6 months after delivery. Among these women – drawn from six states in the Medicaid Outcomes Distributed Research Network – the pooled average probability of HCV testing during pregnancy was 70.3% (95% confidence interval, 61.5%-79.1%). Of these, 30.9% (95% CI, 23.8%-38%) tested positive. At 60 days postpartum, just 3.2% (95% CI, 2.6%-3.8%) had a follow-up visit or treatment for HCV. In a subset of patients followed for 6 months, only 5.9% (95% CI, 4.9%-6.9%) had any HCV follow-up visit or medication within 6 months of delivery.

While HCV screening and diagnosis rates varied across states, postpartum follow-up rates were universally low. The results suggest a need to improve the cascade of postpartum care for HCV and, ultimately perhaps, introduce antenatal HCV treatment, as is currently given safely for HIV, if current clinical research establishes safety, according to Marian P. Jarlenski, PhD, MPH, an associate professor of public health policy and management at the University of Pittsburgh. The study was published in Obstetrics & Gynecology.

HCV infection has risen substantially in people of reproductive age in tandem with an increase in OUDs. HCV is transmitted from an infected mother to her baby in about 6% of cases, according to the Centers for Disease Control and Prevention, which in 2020 expanded its HCV screening recommendations to include all pregnant women. Currently no treatment for HCV during pregnancy has been approved.

In light of those recent recommendations, Dr. Jarlenski said in an interview that her group was “interested in looking at high-risk screened people and estimating what proportion received follow-up care and treatment for HCV. What is the promise of screening? The promise is that you can treat. Otherwise why screen?”

She acknowledged, however, that the postpartum period is a challenging time for a mother to seek health information or care for herself, whether she’s a new parent or has other children in the home. Nevertheless, the low rate of follow-up and treatment was unexpected. “Even the 70% rate of screening was low – we felt it should have been closer to 100% – but the follow-up rate was surprisingly low,” Dr. Jarlenski said.

Mishka Terplan, MD, MPH, medical director of Friends Research Institute in Baltimore, was not surprised at the low follow-up rate. “The cascade of care for hep C is demoralizing,” said Dr. Terplan, who was not involved in the study. “We know that hep C is syndemic with OUD and other opioid crises and we know that screening is effective for identifying hep C and that antiviral medications are now more effective and less toxic than ever before. But despite this, we’re failing pregnant women and their kids at every step along the cascade. We do a better job with initial testing than with the follow-up testing. We do a horrible job with postpartum medication initiation.”

He pointed to the systemic challenges mothers face in getting postpartum HCV care. “They may be transferred to a subspecialist for treatment, and this transfer is compounded by issues of insurance coverage and eligibility.” With the onus on new mothers to submit the paperwork, “the idea that mothers would be able to initiate much less continue postpartum treatment is absurd,” Dr. Terplan said.

He added that the children born to HCV-positive mothers need surveillance as well, but data suggest that the rates of newborn testing are also low. “There’s a preventable public health burden in all of this.”

The obvious way to increase eradicative therapy would be to treat women while they are getting antenatal care. A small phase 1 trial found that all pregnant participants who were HCV positive and given antivirals in their second trimester were safely treated and gave birth to healthy babies.

“If larger trials prove this treatment is safe and effective, then these results should be communicated to care providers and pregnant patients,” Dr. Jarlenski said. Otherwise, the public health potential of universal screening in pregnancy will not be realized.

This research was supported by the National Institute of Drug Abuse and by the Delaware Division of Medicaid and Medical Assistance and the University of Delaware, Center for Community Research & Service. Dr. Jarlenski disclosed no competing interests. One coauthor disclosed grant funding through her institution from Gilead Sciences and Organon unrelated to this work. Dr. Terplan reported no relevant competing interests.

Despite the availability of effective direct-acting antivirals, very few a mothers with opioid use disorder (OUD) and hepatitis C virus (HCV) during pregnancy received follow-up care or treatment for the infection within 6 months of giving birth, a retrospective study of Medicaid maternity patients found.

The study pooled data on 23,780 Medicaid-enrolled pregnant women with OUD who had a live or stillbirth during 2016-2019 and were followed for 6 months after delivery. Among these women – drawn from six states in the Medicaid Outcomes Distributed Research Network – the pooled average probability of HCV testing during pregnancy was 70.3% (95% confidence interval, 61.5%-79.1%). Of these, 30.9% (95% CI, 23.8%-38%) tested positive. At 60 days postpartum, just 3.2% (95% CI, 2.6%-3.8%) had a follow-up visit or treatment for HCV. In a subset of patients followed for 6 months, only 5.9% (95% CI, 4.9%-6.9%) had any HCV follow-up visit or medication within 6 months of delivery.

While HCV screening and diagnosis rates varied across states, postpartum follow-up rates were universally low. The results suggest a need to improve the cascade of postpartum care for HCV and, ultimately perhaps, introduce antenatal HCV treatment, as is currently given safely for HIV, if current clinical research establishes safety, according to Marian P. Jarlenski, PhD, MPH, an associate professor of public health policy and management at the University of Pittsburgh. The study was published in Obstetrics & Gynecology.

HCV infection has risen substantially in people of reproductive age in tandem with an increase in OUDs. HCV is transmitted from an infected mother to her baby in about 6% of cases, according to the Centers for Disease Control and Prevention, which in 2020 expanded its HCV screening recommendations to include all pregnant women. Currently no treatment for HCV during pregnancy has been approved.

In light of those recent recommendations, Dr. Jarlenski said in an interview that her group was “interested in looking at high-risk screened people and estimating what proportion received follow-up care and treatment for HCV. What is the promise of screening? The promise is that you can treat. Otherwise why screen?”

She acknowledged, however, that the postpartum period is a challenging time for a mother to seek health information or care for herself, whether she’s a new parent or has other children in the home. Nevertheless, the low rate of follow-up and treatment was unexpected. “Even the 70% rate of screening was low – we felt it should have been closer to 100% – but the follow-up rate was surprisingly low,” Dr. Jarlenski said.

Mishka Terplan, MD, MPH, medical director of Friends Research Institute in Baltimore, was not surprised at the low follow-up rate. “The cascade of care for hep C is demoralizing,” said Dr. Terplan, who was not involved in the study. “We know that hep C is syndemic with OUD and other opioid crises and we know that screening is effective for identifying hep C and that antiviral medications are now more effective and less toxic than ever before. But despite this, we’re failing pregnant women and their kids at every step along the cascade. We do a better job with initial testing than with the follow-up testing. We do a horrible job with postpartum medication initiation.”

He pointed to the systemic challenges mothers face in getting postpartum HCV care. “They may be transferred to a subspecialist for treatment, and this transfer is compounded by issues of insurance coverage and eligibility.” With the onus on new mothers to submit the paperwork, “the idea that mothers would be able to initiate much less continue postpartum treatment is absurd,” Dr. Terplan said.

He added that the children born to HCV-positive mothers need surveillance as well, but data suggest that the rates of newborn testing are also low. “There’s a preventable public health burden in all of this.”

The obvious way to increase eradicative therapy would be to treat women while they are getting antenatal care. A small phase 1 trial found that all pregnant participants who were HCV positive and given antivirals in their second trimester were safely treated and gave birth to healthy babies.

“If larger trials prove this treatment is safe and effective, then these results should be communicated to care providers and pregnant patients,” Dr. Jarlenski said. Otherwise, the public health potential of universal screening in pregnancy will not be realized.

This research was supported by the National Institute of Drug Abuse and by the Delaware Division of Medicaid and Medical Assistance and the University of Delaware, Center for Community Research & Service. Dr. Jarlenski disclosed no competing interests. One coauthor disclosed grant funding through her institution from Gilead Sciences and Organon unrelated to this work. Dr. Terplan reported no relevant competing interests.