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Hospital medicine gains popularity among newly minted physicians
In a new study, published in Annals of Internal Medicine, researchers from ABIM reviewed certification data from 67,902 general internists, accounting for 80% of all general internists certified in the United States from 1990 to 2017.
The researchers also used data from Medicare fee-for-service claims from 2008-2018 to measure and categorize practice setting types. The claims were from patients aged 65 years or older with at least 20 evaluation and management visits each year. Practice settings were categorized as hospitalist, outpatient, or mixed.
“ABIM is always working to understand the real-life experience of physicians, and this project grew out of that sort of analysis,” lead author Bradley M. Gray, PhD, a health services researcher at ABIM in Philadelphia, said in an interview. “We wanted to better understand practice setting, because that relates to the kinds of questions that we ask on our certifying exams. When we did this, we noticed a trend toward hospital medicine.”
Overall, the percentages of general internists in hospitalist practice and outpatient-only practice increased during the study period, from 25% to 40% and from 23% to 38%, respectively. By contrast, the percentage of general internists in a mixed-practice setting decreased from 52% to 23%, a 56% decline. Most of the physicians who left the mixed practice setting switched to outpatient-only practices.
Among the internists certified in 2017, 71% practiced as hospitalists, compared with 8% practicing as outpatient-only physicians. Most physicians remained in their original choice of practice setting. For physicians certified in 1999 and 2012, 86% and 85%, respectively, of those who chose hospitalist medicine remained in the hospital setting 5 years later, as did 95% of outpatient physicians, but only 57% of mixed-practice physicians.
The shift to outpatient practice among senior physicians offset the potential decline in outpatient primary care resulting from the increased choice of hospitalist medicine by new internists, the researchers noted.
The study findings were limited by several factors, including the reliance on Medicare fee-for-service claims, the researchers noted.
“We were surprised by both the dramatic shift toward hospital medicine by new physicians and the shift to outpatient only (an extreme category) for more senior physicians,” Dr. Gray said in an interview.
The shift toward outpatient practice among older physicians may be driven by convenience, said Dr. Gray. “I suspect that it is more efficient to specialize in terms of practice setting. Only seeing patients in the outpatient setting means that you don’t have to travel to the hospital, which can be time consuming.
“Also, with fewer new physicians going into primary care, older physicians need to focus on outpatient visits. This could be problematic in the future as more senior physicians retire and are replaced by new physicians who focus on hospital care,” which could lead to more shortages in primary care physicians, he explained.
The trend toward hospital medicine as a career has been going on since before the pandemic, said Dr. Gray. “I don’t think the pandemic will ultimately impact this trend. That said, at least in the short run, there may have been a decreased demand for primary care, but that is just my speculation. As more data flow in we will be able to answer this question more directly.”
Next steps for research included digging deeper into the data to understand the nature of conditions facing hospitalists, Dr. Gray said.
Implications for primary care
“This study provides an updated snapshot of the popularity of hospital medicine,” said Bradley A. Sharpe, MD, of the division of hospital medicine at the University of California, San Francisco. “It is also important to conduct this study now as health systems think about the challenge of providing high-quality primary care with a rapidly decreasing number of internists choosing to practice outpatient medicine.” Dr. Sharpe was not involved in the study.
“The most surprising finding to me was not the increase in general internists focusing on hospital medicine, but the amount of the increase; it is remarkable that nearly three quarters of general internists are choosing to practice as hospitalists,” Dr. Sharpe noted.
“I think there are a number of key factors at play,” he said. “First, as hospital medicine as a field is now more than 25 years old, hospitals and health systems have evolved to create hospital medicine jobs that are interesting, engaging, rewarding (financially and otherwise), doable, and sustainable. Second, being an outpatient internist is incredibly challenging; multiple studies have shown that it is essentially impossible to complete the evidence-based preventive care for a panel of patients on top of everything else. We know burnout rates are often higher among primary care and family medicine providers. On top of that, the expansion of electronic health records and patient access has led to a massive increase in messages to providers; this has been shown to be associated with burnout.”
The potential impact of the pandemic on physicians’ choices and the trend toward hospital medicine is an interested question, Dr. Sharpe said. The current study showed only trends through 2017.
“To be honest, I think it is difficult to predict,” he said. “Hospitalists shouldered much of the burden of COVID care nationally and burnout rates are high. One could imagine the extra work (as well as concern for personal safety) could lead to fewer providers choosing hospital medicine.
“At the same time, the pandemic has driven many of us to reflect on life and our values and what is important and, through that lens, providers might choose hospital medicine as a more sustainable, do-able, rewarding, and enjoyable career choice,” Dr. Sharpe emphasized.
“Additional research could explore the drivers of this clear trend toward hospital medicine. Determining what is motivating this trend could help hospitals and health systems ensure they have the right workforce for the future and, in particular, how to create outpatient positions that are attractive and rewarding,” he said.
The study received no outside funding. The researchers and Dr. Sharpe disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a new study, published in Annals of Internal Medicine, researchers from ABIM reviewed certification data from 67,902 general internists, accounting for 80% of all general internists certified in the United States from 1990 to 2017.
The researchers also used data from Medicare fee-for-service claims from 2008-2018 to measure and categorize practice setting types. The claims were from patients aged 65 years or older with at least 20 evaluation and management visits each year. Practice settings were categorized as hospitalist, outpatient, or mixed.
“ABIM is always working to understand the real-life experience of physicians, and this project grew out of that sort of analysis,” lead author Bradley M. Gray, PhD, a health services researcher at ABIM in Philadelphia, said in an interview. “We wanted to better understand practice setting, because that relates to the kinds of questions that we ask on our certifying exams. When we did this, we noticed a trend toward hospital medicine.”
Overall, the percentages of general internists in hospitalist practice and outpatient-only practice increased during the study period, from 25% to 40% and from 23% to 38%, respectively. By contrast, the percentage of general internists in a mixed-practice setting decreased from 52% to 23%, a 56% decline. Most of the physicians who left the mixed practice setting switched to outpatient-only practices.
Among the internists certified in 2017, 71% practiced as hospitalists, compared with 8% practicing as outpatient-only physicians. Most physicians remained in their original choice of practice setting. For physicians certified in 1999 and 2012, 86% and 85%, respectively, of those who chose hospitalist medicine remained in the hospital setting 5 years later, as did 95% of outpatient physicians, but only 57% of mixed-practice physicians.
The shift to outpatient practice among senior physicians offset the potential decline in outpatient primary care resulting from the increased choice of hospitalist medicine by new internists, the researchers noted.
The study findings were limited by several factors, including the reliance on Medicare fee-for-service claims, the researchers noted.
“We were surprised by both the dramatic shift toward hospital medicine by new physicians and the shift to outpatient only (an extreme category) for more senior physicians,” Dr. Gray said in an interview.
The shift toward outpatient practice among older physicians may be driven by convenience, said Dr. Gray. “I suspect that it is more efficient to specialize in terms of practice setting. Only seeing patients in the outpatient setting means that you don’t have to travel to the hospital, which can be time consuming.
“Also, with fewer new physicians going into primary care, older physicians need to focus on outpatient visits. This could be problematic in the future as more senior physicians retire and are replaced by new physicians who focus on hospital care,” which could lead to more shortages in primary care physicians, he explained.
The trend toward hospital medicine as a career has been going on since before the pandemic, said Dr. Gray. “I don’t think the pandemic will ultimately impact this trend. That said, at least in the short run, there may have been a decreased demand for primary care, but that is just my speculation. As more data flow in we will be able to answer this question more directly.”
Next steps for research included digging deeper into the data to understand the nature of conditions facing hospitalists, Dr. Gray said.
Implications for primary care
“This study provides an updated snapshot of the popularity of hospital medicine,” said Bradley A. Sharpe, MD, of the division of hospital medicine at the University of California, San Francisco. “It is also important to conduct this study now as health systems think about the challenge of providing high-quality primary care with a rapidly decreasing number of internists choosing to practice outpatient medicine.” Dr. Sharpe was not involved in the study.
“The most surprising finding to me was not the increase in general internists focusing on hospital medicine, but the amount of the increase; it is remarkable that nearly three quarters of general internists are choosing to practice as hospitalists,” Dr. Sharpe noted.
“I think there are a number of key factors at play,” he said. “First, as hospital medicine as a field is now more than 25 years old, hospitals and health systems have evolved to create hospital medicine jobs that are interesting, engaging, rewarding (financially and otherwise), doable, and sustainable. Second, being an outpatient internist is incredibly challenging; multiple studies have shown that it is essentially impossible to complete the evidence-based preventive care for a panel of patients on top of everything else. We know burnout rates are often higher among primary care and family medicine providers. On top of that, the expansion of electronic health records and patient access has led to a massive increase in messages to providers; this has been shown to be associated with burnout.”
The potential impact of the pandemic on physicians’ choices and the trend toward hospital medicine is an interested question, Dr. Sharpe said. The current study showed only trends through 2017.
“To be honest, I think it is difficult to predict,” he said. “Hospitalists shouldered much of the burden of COVID care nationally and burnout rates are high. One could imagine the extra work (as well as concern for personal safety) could lead to fewer providers choosing hospital medicine.
“At the same time, the pandemic has driven many of us to reflect on life and our values and what is important and, through that lens, providers might choose hospital medicine as a more sustainable, do-able, rewarding, and enjoyable career choice,” Dr. Sharpe emphasized.
“Additional research could explore the drivers of this clear trend toward hospital medicine. Determining what is motivating this trend could help hospitals and health systems ensure they have the right workforce for the future and, in particular, how to create outpatient positions that are attractive and rewarding,” he said.
The study received no outside funding. The researchers and Dr. Sharpe disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a new study, published in Annals of Internal Medicine, researchers from ABIM reviewed certification data from 67,902 general internists, accounting for 80% of all general internists certified in the United States from 1990 to 2017.
The researchers also used data from Medicare fee-for-service claims from 2008-2018 to measure and categorize practice setting types. The claims were from patients aged 65 years or older with at least 20 evaluation and management visits each year. Practice settings were categorized as hospitalist, outpatient, or mixed.
“ABIM is always working to understand the real-life experience of physicians, and this project grew out of that sort of analysis,” lead author Bradley M. Gray, PhD, a health services researcher at ABIM in Philadelphia, said in an interview. “We wanted to better understand practice setting, because that relates to the kinds of questions that we ask on our certifying exams. When we did this, we noticed a trend toward hospital medicine.”
Overall, the percentages of general internists in hospitalist practice and outpatient-only practice increased during the study period, from 25% to 40% and from 23% to 38%, respectively. By contrast, the percentage of general internists in a mixed-practice setting decreased from 52% to 23%, a 56% decline. Most of the physicians who left the mixed practice setting switched to outpatient-only practices.
Among the internists certified in 2017, 71% practiced as hospitalists, compared with 8% practicing as outpatient-only physicians. Most physicians remained in their original choice of practice setting. For physicians certified in 1999 and 2012, 86% and 85%, respectively, of those who chose hospitalist medicine remained in the hospital setting 5 years later, as did 95% of outpatient physicians, but only 57% of mixed-practice physicians.
The shift to outpatient practice among senior physicians offset the potential decline in outpatient primary care resulting from the increased choice of hospitalist medicine by new internists, the researchers noted.
The study findings were limited by several factors, including the reliance on Medicare fee-for-service claims, the researchers noted.
“We were surprised by both the dramatic shift toward hospital medicine by new physicians and the shift to outpatient only (an extreme category) for more senior physicians,” Dr. Gray said in an interview.
The shift toward outpatient practice among older physicians may be driven by convenience, said Dr. Gray. “I suspect that it is more efficient to specialize in terms of practice setting. Only seeing patients in the outpatient setting means that you don’t have to travel to the hospital, which can be time consuming.
“Also, with fewer new physicians going into primary care, older physicians need to focus on outpatient visits. This could be problematic in the future as more senior physicians retire and are replaced by new physicians who focus on hospital care,” which could lead to more shortages in primary care physicians, he explained.
The trend toward hospital medicine as a career has been going on since before the pandemic, said Dr. Gray. “I don’t think the pandemic will ultimately impact this trend. That said, at least in the short run, there may have been a decreased demand for primary care, but that is just my speculation. As more data flow in we will be able to answer this question more directly.”
Next steps for research included digging deeper into the data to understand the nature of conditions facing hospitalists, Dr. Gray said.
Implications for primary care
“This study provides an updated snapshot of the popularity of hospital medicine,” said Bradley A. Sharpe, MD, of the division of hospital medicine at the University of California, San Francisco. “It is also important to conduct this study now as health systems think about the challenge of providing high-quality primary care with a rapidly decreasing number of internists choosing to practice outpatient medicine.” Dr. Sharpe was not involved in the study.
“The most surprising finding to me was not the increase in general internists focusing on hospital medicine, but the amount of the increase; it is remarkable that nearly three quarters of general internists are choosing to practice as hospitalists,” Dr. Sharpe noted.
“I think there are a number of key factors at play,” he said. “First, as hospital medicine as a field is now more than 25 years old, hospitals and health systems have evolved to create hospital medicine jobs that are interesting, engaging, rewarding (financially and otherwise), doable, and sustainable. Second, being an outpatient internist is incredibly challenging; multiple studies have shown that it is essentially impossible to complete the evidence-based preventive care for a panel of patients on top of everything else. We know burnout rates are often higher among primary care and family medicine providers. On top of that, the expansion of electronic health records and patient access has led to a massive increase in messages to providers; this has been shown to be associated with burnout.”
The potential impact of the pandemic on physicians’ choices and the trend toward hospital medicine is an interested question, Dr. Sharpe said. The current study showed only trends through 2017.
“To be honest, I think it is difficult to predict,” he said. “Hospitalists shouldered much of the burden of COVID care nationally and burnout rates are high. One could imagine the extra work (as well as concern for personal safety) could lead to fewer providers choosing hospital medicine.
“At the same time, the pandemic has driven many of us to reflect on life and our values and what is important and, through that lens, providers might choose hospital medicine as a more sustainable, do-able, rewarding, and enjoyable career choice,” Dr. Sharpe emphasized.
“Additional research could explore the drivers of this clear trend toward hospital medicine. Determining what is motivating this trend could help hospitals and health systems ensure they have the right workforce for the future and, in particular, how to create outpatient positions that are attractive and rewarding,” he said.
The study received no outside funding. The researchers and Dr. Sharpe disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Mother’s distress disrupts fetal brain development
Babies of mothers who experience significant psychological distress during pregnancy showed evidence of altered brain development in utero and reduced cognitive outcomes at 18 months, based on data from a pair of studies including approximately 300 women.
In a longitudinal study published in JAMA Network Open, Yao Wu, PhD, of Children’s National Hospital, Washington, and colleagues recruited 97 healthy mother-infant dyads between January 2016 and October 2020 at a single center. Of these, 87 underwent two fetal brain imaging studies each, and 10 completed the first MRI visit, for a total of 184 fetal MRIs.
Neurodevelopment and social-emotional development for infants at 18 months of age was measured using the Bayley Scales of Infant and Toddler Development and Infant-Toddler Social and Emotional Assessment. The mean age of the mothers was 35 years; maternal distress was assessed between 24 and 40 weeks’ gestation using validated self-report questionnaires. Parenting stress was assessed at the 18-month infant testing using the Parenting Stress Index-Short Form.
Overall, prenatal maternal stress was negatively associated with infant cognitive performance (P = .01) at 18 months, mediated by fetal left hippocampal volume.
In addition, increased fetal cortical local gyrification index and sulcal depth measured during reported times of prenatal maternal distress were associated with significantly poorer social-emotional scores and competence scores at age 18 months. The beta coefficients for local gyrification index and sulcal depth were –54.62 and –14.22, respectively, for social-emotional and competence scores, –24.01 and –7.53, respectively; P values were P < .001, P < .002, P = .003, P < .001, respectively.
“Increased cortical gyrification has been suggested in children with dyslexia and autism, and sulcal depth has been associated with the severity of impaired performance on working memory and executive function in adults with schizophrenia,” the researchers wrote in their discussion of the findings.
The current study “extends our previous findings and suggests a critical role for disturbances in emerging fetal cerebral cortical folding development in mediating the association between prenatal maternal distress and neurodevelopmental problems that later manifest in infancy,” they explained.
The researchers also found that prenatal maternal anxiety, stress, and depression were positively associated with all measures of parenting stress at the 18-month testing visit.
The study findings were limited by several factors including the use of self-reports for both maternal distress and infant social-emotional assessment, despite the use of validated questionnaires, and the fact that assessment of maternal distress at specific times may not reflect the entire pregnancy, the researchers noted. Other potential limitations included the inability to use some MRI data because of fetal movement and the homogenous population of relatively highly educated women with access to health care that may not reflect other areas, they said.
“Identifying early brain developmental biomarkers may help improve the identification of infants at risk for later neurodevelopmental impairment who might benefit from early targeted interventions,” the researchers concluded.
Technology enhances health and disease models
The effect of the prenatal period on future well-being is recognized, but the current study makes “substantial contributions to prenatal programming science, with implications for ways to transform the prenatal care ecosystem for two-generation impact,” Catherine Monk, PhD, and Cristina R. Fernández, MD, both of Columbia University, New York, wrote in an accompanying editorial.
The developmental origins of health and disease (DOHaD) conceptual model introduced by Dr. David Barker in 1995 were later applied to show that maternal stress, depression, and anxiety affected child prenatal and future development, they said. However, the current study uses cutting-edge neuroscience to directly assess developing fetal brains. The finding of reduced cognitive functioning at 18 months associated with maternal stress is consistent with other findings, they noted.
“Finding an association between maternal prenatal stress and infant cognitive outcomes in the setting of what may be modest stress relative to that of a low-resourced or historically marginalized sample underscores the importance of this research; presumably, with higher stress, and greater social determinants of health burden, the effect sizes would be even greater and of greater concern,” they said.
However, studies such as the current one “have the potential to transform the prenatal and postpartum care ecosystems,” by encouraging a whole-person approach to the care of pregnant women, including attention to mental well-being and quality of life, they emphasized.
COVID-19 stress considerations
In a separate study published in Communications Medicine, Yuan-Chiao Lu, MD, also of Children’s National Hospital in Washington, and colleagues found a similar effect of maternal stress on fetal brain development.
The researchers imaged the brains of fetuses before and during the COVID-19 pandemic and interviewed mothers about any distress they experienced during pregnancy.
The study population included 65 women with known COVID-19 exposures who underwent 92 fetal MRIs and 137 prepandemic controls who underwent 182 fetal MRIs. Maternal distress was measured via the Spielberger State Anxiety Inventory, Spielberger Trait Anxiety Inventory, Perceived Stress Scale, and Edinburgh Postnatal Depression Scale.
Overall, scores on measures of stress and depression were significantly higher for women in the pandemic group compared with controls. Of the 173 women for whom maternal distress measures were available, 28% of the prepandemic group and 52% of the pandemic group met criteria for elevated maternal psychological distress, defined as above the threshold for distress on any one of the four measures.
After the researchers controlled for maternal distress, MRI data showed decreases in fetal white matter and in hippocampal and cerebellar volumes in fetuses in the pandemic group compared with controls.
Other signs of impaired brain development were similar to those seen in the JAMA Network Open study, including decreased cortical surface area and local gyrification index, as well as reduced sulcal depth in multiple brain lobes, indicating delayed cerebral cortical gyrification.
The second study was limited by a lack of data on other lifestyle changes during the pandemic that might influence maternal health and fetal development, the researchers noted. Other limitations were the possible lack of generalizability to a range of racial and ethnic populations and geographic areas outside of Washington, and the inability to control for unknown COVID-19 exposures or subclinical infections in controls, they said.
However, the results support findings from previous studies, and provide a unique opportunity to study the effect of prenatal stress on early development, as well as a chance to implement “novel and timely interventions,” the researchers wrote.
“Monitoring the COVID generation of infants for long-term cognitive and health outcomes after birth is warranted and currently underway,” and continued research may inform preventive strategies for pregnant women experiencing multiple stressors beyond the pandemic, they concluded.
Interpret pandemic effect with caution
“Research studies, as well as our own daily experiences, have made it abundantly clear that stress is on the rise as a consequence of the COVID-19 pandemic,” said editorial author Dr. Monk, who commented on the second study in an interview. “This is an important public health question: Early identification of pandemic effects on child development can help garner the necessary resources to intervene early, dramatically increasing the likelihood of improving that child’s developmental trajectory,” she said.
“The pandemic is an unprecedented experience that has widespread impact on people’s lives, how could it not also alter gestational biology and the developing brain? That being said, we need to be cautious in that we do not yet know the functional implications of these brain changes for longer-term development,” Dr. Monk said. “Also, we do not know what aspects of women’s pandemic-affected lives had an influence on fetal brain development. The authors found higher stress in pandemic versus nonpandemic women, but not evidence that distress was the mediating variable relating pregnancy during the pandemic to altered brain development,” she explained.
The take-home message for clinicians is to “provide your patients with realistic avenues for neurodevelopmental assessments of their children if they, or you, have concerns,” Dr. Monk said. “However, do not prejudge ‘pandemic babies,’ as not all children will be affected by these potential pandemic effects,” she emphasized. “It is possible to misjudge normal variation in children’s development and unnecessarily raise parents’ anxiety levels. Importantly, this period of brain plasticity means any needed intervention likely can have a big, ameliorating impact,” she added.
“We need follow-up studies looking at pandemic effects on prenatal and postnatal development and what factors protect the fetus and birthing person from the negative influences,” she said.
The JAMA study was supported by the National Institutes of Health and the A. James & Alice B. Clark Foundation. The study in Communications Medicine was supported by the National Institutes of Health, the Intellectual and Developmental Disabilities Research Center, and the A. James & Alice B. Clark Foundation. None of the researchers in either study disclosed conflicts of interest. Dr. Monk disclosed grants from the National Institutes of Health, the Bezos Family Foundation, and the Robin Hood Foundation outside the submitted work.
Babies of mothers who experience significant psychological distress during pregnancy showed evidence of altered brain development in utero and reduced cognitive outcomes at 18 months, based on data from a pair of studies including approximately 300 women.
In a longitudinal study published in JAMA Network Open, Yao Wu, PhD, of Children’s National Hospital, Washington, and colleagues recruited 97 healthy mother-infant dyads between January 2016 and October 2020 at a single center. Of these, 87 underwent two fetal brain imaging studies each, and 10 completed the first MRI visit, for a total of 184 fetal MRIs.
Neurodevelopment and social-emotional development for infants at 18 months of age was measured using the Bayley Scales of Infant and Toddler Development and Infant-Toddler Social and Emotional Assessment. The mean age of the mothers was 35 years; maternal distress was assessed between 24 and 40 weeks’ gestation using validated self-report questionnaires. Parenting stress was assessed at the 18-month infant testing using the Parenting Stress Index-Short Form.
Overall, prenatal maternal stress was negatively associated with infant cognitive performance (P = .01) at 18 months, mediated by fetal left hippocampal volume.
In addition, increased fetal cortical local gyrification index and sulcal depth measured during reported times of prenatal maternal distress were associated with significantly poorer social-emotional scores and competence scores at age 18 months. The beta coefficients for local gyrification index and sulcal depth were –54.62 and –14.22, respectively, for social-emotional and competence scores, –24.01 and –7.53, respectively; P values were P < .001, P < .002, P = .003, P < .001, respectively.
“Increased cortical gyrification has been suggested in children with dyslexia and autism, and sulcal depth has been associated with the severity of impaired performance on working memory and executive function in adults with schizophrenia,” the researchers wrote in their discussion of the findings.
The current study “extends our previous findings and suggests a critical role for disturbances in emerging fetal cerebral cortical folding development in mediating the association between prenatal maternal distress and neurodevelopmental problems that later manifest in infancy,” they explained.
The researchers also found that prenatal maternal anxiety, stress, and depression were positively associated with all measures of parenting stress at the 18-month testing visit.
The study findings were limited by several factors including the use of self-reports for both maternal distress and infant social-emotional assessment, despite the use of validated questionnaires, and the fact that assessment of maternal distress at specific times may not reflect the entire pregnancy, the researchers noted. Other potential limitations included the inability to use some MRI data because of fetal movement and the homogenous population of relatively highly educated women with access to health care that may not reflect other areas, they said.
“Identifying early brain developmental biomarkers may help improve the identification of infants at risk for later neurodevelopmental impairment who might benefit from early targeted interventions,” the researchers concluded.
Technology enhances health and disease models
The effect of the prenatal period on future well-being is recognized, but the current study makes “substantial contributions to prenatal programming science, with implications for ways to transform the prenatal care ecosystem for two-generation impact,” Catherine Monk, PhD, and Cristina R. Fernández, MD, both of Columbia University, New York, wrote in an accompanying editorial.
The developmental origins of health and disease (DOHaD) conceptual model introduced by Dr. David Barker in 1995 were later applied to show that maternal stress, depression, and anxiety affected child prenatal and future development, they said. However, the current study uses cutting-edge neuroscience to directly assess developing fetal brains. The finding of reduced cognitive functioning at 18 months associated with maternal stress is consistent with other findings, they noted.
“Finding an association between maternal prenatal stress and infant cognitive outcomes in the setting of what may be modest stress relative to that of a low-resourced or historically marginalized sample underscores the importance of this research; presumably, with higher stress, and greater social determinants of health burden, the effect sizes would be even greater and of greater concern,” they said.
However, studies such as the current one “have the potential to transform the prenatal and postpartum care ecosystems,” by encouraging a whole-person approach to the care of pregnant women, including attention to mental well-being and quality of life, they emphasized.
COVID-19 stress considerations
In a separate study published in Communications Medicine, Yuan-Chiao Lu, MD, also of Children’s National Hospital in Washington, and colleagues found a similar effect of maternal stress on fetal brain development.
The researchers imaged the brains of fetuses before and during the COVID-19 pandemic and interviewed mothers about any distress they experienced during pregnancy.
The study population included 65 women with known COVID-19 exposures who underwent 92 fetal MRIs and 137 prepandemic controls who underwent 182 fetal MRIs. Maternal distress was measured via the Spielberger State Anxiety Inventory, Spielberger Trait Anxiety Inventory, Perceived Stress Scale, and Edinburgh Postnatal Depression Scale.
Overall, scores on measures of stress and depression were significantly higher for women in the pandemic group compared with controls. Of the 173 women for whom maternal distress measures were available, 28% of the prepandemic group and 52% of the pandemic group met criteria for elevated maternal psychological distress, defined as above the threshold for distress on any one of the four measures.
After the researchers controlled for maternal distress, MRI data showed decreases in fetal white matter and in hippocampal and cerebellar volumes in fetuses in the pandemic group compared with controls.
Other signs of impaired brain development were similar to those seen in the JAMA Network Open study, including decreased cortical surface area and local gyrification index, as well as reduced sulcal depth in multiple brain lobes, indicating delayed cerebral cortical gyrification.
The second study was limited by a lack of data on other lifestyle changes during the pandemic that might influence maternal health and fetal development, the researchers noted. Other limitations were the possible lack of generalizability to a range of racial and ethnic populations and geographic areas outside of Washington, and the inability to control for unknown COVID-19 exposures or subclinical infections in controls, they said.
However, the results support findings from previous studies, and provide a unique opportunity to study the effect of prenatal stress on early development, as well as a chance to implement “novel and timely interventions,” the researchers wrote.
“Monitoring the COVID generation of infants for long-term cognitive and health outcomes after birth is warranted and currently underway,” and continued research may inform preventive strategies for pregnant women experiencing multiple stressors beyond the pandemic, they concluded.
Interpret pandemic effect with caution
“Research studies, as well as our own daily experiences, have made it abundantly clear that stress is on the rise as a consequence of the COVID-19 pandemic,” said editorial author Dr. Monk, who commented on the second study in an interview. “This is an important public health question: Early identification of pandemic effects on child development can help garner the necessary resources to intervene early, dramatically increasing the likelihood of improving that child’s developmental trajectory,” she said.
“The pandemic is an unprecedented experience that has widespread impact on people’s lives, how could it not also alter gestational biology and the developing brain? That being said, we need to be cautious in that we do not yet know the functional implications of these brain changes for longer-term development,” Dr. Monk said. “Also, we do not know what aspects of women’s pandemic-affected lives had an influence on fetal brain development. The authors found higher stress in pandemic versus nonpandemic women, but not evidence that distress was the mediating variable relating pregnancy during the pandemic to altered brain development,” she explained.
The take-home message for clinicians is to “provide your patients with realistic avenues for neurodevelopmental assessments of their children if they, or you, have concerns,” Dr. Monk said. “However, do not prejudge ‘pandemic babies,’ as not all children will be affected by these potential pandemic effects,” she emphasized. “It is possible to misjudge normal variation in children’s development and unnecessarily raise parents’ anxiety levels. Importantly, this period of brain plasticity means any needed intervention likely can have a big, ameliorating impact,” she added.
“We need follow-up studies looking at pandemic effects on prenatal and postnatal development and what factors protect the fetus and birthing person from the negative influences,” she said.
The JAMA study was supported by the National Institutes of Health and the A. James & Alice B. Clark Foundation. The study in Communications Medicine was supported by the National Institutes of Health, the Intellectual and Developmental Disabilities Research Center, and the A. James & Alice B. Clark Foundation. None of the researchers in either study disclosed conflicts of interest. Dr. Monk disclosed grants from the National Institutes of Health, the Bezos Family Foundation, and the Robin Hood Foundation outside the submitted work.
Babies of mothers who experience significant psychological distress during pregnancy showed evidence of altered brain development in utero and reduced cognitive outcomes at 18 months, based on data from a pair of studies including approximately 300 women.
In a longitudinal study published in JAMA Network Open, Yao Wu, PhD, of Children’s National Hospital, Washington, and colleagues recruited 97 healthy mother-infant dyads between January 2016 and October 2020 at a single center. Of these, 87 underwent two fetal brain imaging studies each, and 10 completed the first MRI visit, for a total of 184 fetal MRIs.
Neurodevelopment and social-emotional development for infants at 18 months of age was measured using the Bayley Scales of Infant and Toddler Development and Infant-Toddler Social and Emotional Assessment. The mean age of the mothers was 35 years; maternal distress was assessed between 24 and 40 weeks’ gestation using validated self-report questionnaires. Parenting stress was assessed at the 18-month infant testing using the Parenting Stress Index-Short Form.
Overall, prenatal maternal stress was negatively associated with infant cognitive performance (P = .01) at 18 months, mediated by fetal left hippocampal volume.
In addition, increased fetal cortical local gyrification index and sulcal depth measured during reported times of prenatal maternal distress were associated with significantly poorer social-emotional scores and competence scores at age 18 months. The beta coefficients for local gyrification index and sulcal depth were –54.62 and –14.22, respectively, for social-emotional and competence scores, –24.01 and –7.53, respectively; P values were P < .001, P < .002, P = .003, P < .001, respectively.
“Increased cortical gyrification has been suggested in children with dyslexia and autism, and sulcal depth has been associated with the severity of impaired performance on working memory and executive function in adults with schizophrenia,” the researchers wrote in their discussion of the findings.
The current study “extends our previous findings and suggests a critical role for disturbances in emerging fetal cerebral cortical folding development in mediating the association between prenatal maternal distress and neurodevelopmental problems that later manifest in infancy,” they explained.
The researchers also found that prenatal maternal anxiety, stress, and depression were positively associated with all measures of parenting stress at the 18-month testing visit.
The study findings were limited by several factors including the use of self-reports for both maternal distress and infant social-emotional assessment, despite the use of validated questionnaires, and the fact that assessment of maternal distress at specific times may not reflect the entire pregnancy, the researchers noted. Other potential limitations included the inability to use some MRI data because of fetal movement and the homogenous population of relatively highly educated women with access to health care that may not reflect other areas, they said.
“Identifying early brain developmental biomarkers may help improve the identification of infants at risk for later neurodevelopmental impairment who might benefit from early targeted interventions,” the researchers concluded.
Technology enhances health and disease models
The effect of the prenatal period on future well-being is recognized, but the current study makes “substantial contributions to prenatal programming science, with implications for ways to transform the prenatal care ecosystem for two-generation impact,” Catherine Monk, PhD, and Cristina R. Fernández, MD, both of Columbia University, New York, wrote in an accompanying editorial.
The developmental origins of health and disease (DOHaD) conceptual model introduced by Dr. David Barker in 1995 were later applied to show that maternal stress, depression, and anxiety affected child prenatal and future development, they said. However, the current study uses cutting-edge neuroscience to directly assess developing fetal brains. The finding of reduced cognitive functioning at 18 months associated with maternal stress is consistent with other findings, they noted.
“Finding an association between maternal prenatal stress and infant cognitive outcomes in the setting of what may be modest stress relative to that of a low-resourced or historically marginalized sample underscores the importance of this research; presumably, with higher stress, and greater social determinants of health burden, the effect sizes would be even greater and of greater concern,” they said.
However, studies such as the current one “have the potential to transform the prenatal and postpartum care ecosystems,” by encouraging a whole-person approach to the care of pregnant women, including attention to mental well-being and quality of life, they emphasized.
COVID-19 stress considerations
In a separate study published in Communications Medicine, Yuan-Chiao Lu, MD, also of Children’s National Hospital in Washington, and colleagues found a similar effect of maternal stress on fetal brain development.
The researchers imaged the brains of fetuses before and during the COVID-19 pandemic and interviewed mothers about any distress they experienced during pregnancy.
The study population included 65 women with known COVID-19 exposures who underwent 92 fetal MRIs and 137 prepandemic controls who underwent 182 fetal MRIs. Maternal distress was measured via the Spielberger State Anxiety Inventory, Spielberger Trait Anxiety Inventory, Perceived Stress Scale, and Edinburgh Postnatal Depression Scale.
Overall, scores on measures of stress and depression were significantly higher for women in the pandemic group compared with controls. Of the 173 women for whom maternal distress measures were available, 28% of the prepandemic group and 52% of the pandemic group met criteria for elevated maternal psychological distress, defined as above the threshold for distress on any one of the four measures.
After the researchers controlled for maternal distress, MRI data showed decreases in fetal white matter and in hippocampal and cerebellar volumes in fetuses in the pandemic group compared with controls.
Other signs of impaired brain development were similar to those seen in the JAMA Network Open study, including decreased cortical surface area and local gyrification index, as well as reduced sulcal depth in multiple brain lobes, indicating delayed cerebral cortical gyrification.
The second study was limited by a lack of data on other lifestyle changes during the pandemic that might influence maternal health and fetal development, the researchers noted. Other limitations were the possible lack of generalizability to a range of racial and ethnic populations and geographic areas outside of Washington, and the inability to control for unknown COVID-19 exposures or subclinical infections in controls, they said.
However, the results support findings from previous studies, and provide a unique opportunity to study the effect of prenatal stress on early development, as well as a chance to implement “novel and timely interventions,” the researchers wrote.
“Monitoring the COVID generation of infants for long-term cognitive and health outcomes after birth is warranted and currently underway,” and continued research may inform preventive strategies for pregnant women experiencing multiple stressors beyond the pandemic, they concluded.
Interpret pandemic effect with caution
“Research studies, as well as our own daily experiences, have made it abundantly clear that stress is on the rise as a consequence of the COVID-19 pandemic,” said editorial author Dr. Monk, who commented on the second study in an interview. “This is an important public health question: Early identification of pandemic effects on child development can help garner the necessary resources to intervene early, dramatically increasing the likelihood of improving that child’s developmental trajectory,” she said.
“The pandemic is an unprecedented experience that has widespread impact on people’s lives, how could it not also alter gestational biology and the developing brain? That being said, we need to be cautious in that we do not yet know the functional implications of these brain changes for longer-term development,” Dr. Monk said. “Also, we do not know what aspects of women’s pandemic-affected lives had an influence on fetal brain development. The authors found higher stress in pandemic versus nonpandemic women, but not evidence that distress was the mediating variable relating pregnancy during the pandemic to altered brain development,” she explained.
The take-home message for clinicians is to “provide your patients with realistic avenues for neurodevelopmental assessments of their children if they, or you, have concerns,” Dr. Monk said. “However, do not prejudge ‘pandemic babies,’ as not all children will be affected by these potential pandemic effects,” she emphasized. “It is possible to misjudge normal variation in children’s development and unnecessarily raise parents’ anxiety levels. Importantly, this period of brain plasticity means any needed intervention likely can have a big, ameliorating impact,” she added.
“We need follow-up studies looking at pandemic effects on prenatal and postnatal development and what factors protect the fetus and birthing person from the negative influences,” she said.
The JAMA study was supported by the National Institutes of Health and the A. James & Alice B. Clark Foundation. The study in Communications Medicine was supported by the National Institutes of Health, the Intellectual and Developmental Disabilities Research Center, and the A. James & Alice B. Clark Foundation. None of the researchers in either study disclosed conflicts of interest. Dr. Monk disclosed grants from the National Institutes of Health, the Bezos Family Foundation, and the Robin Hood Foundation outside the submitted work.
FROM JAMA NETWORK OPEN AND COMMUNICATIONS MEDICINE
Parents fall short on infant sleep safety
Less than 10% of parents followed recommended safe sleep practices for their infants aged 12 months and younger at both sleep onset and after nighttime waking, based on data from a survey of 1,500 parents published in Pediatrics.
Sleep-related death remains a major cause of infant mortality in the United States despite the early success of public health campaigns for safe sleep practices, such as “Back to Sleep,” and many parents persist in unsafe practices such as prone positioning and bed-sharing, Mersine A. Bryan, MD, of the University of Washington, Seattle, and colleagues wrote. “Though nighttime waking is common for infants, less attention has been paid to the safety of second-sleep practices.”
To examine the prevalence and safety of infant second-sleep practices, the researchers used a cross-sectional online survey to collect information on sleep practices from parents of infants aged 12 months and younger; 74% of the respondents were female, 65% were White, 12% were Black, and 17% were Hispanic. The mean age of the infants was 6.6 months, and 24% were aged 3 months and younger.
The survey included parent reports of three safe sleep practices based on the American Academy of Pediatrics 2016 Safe Infant Sleep Guidelines: supine infant sleep position, use of a separate sleep space (vs. bed sharing), and use of an approved surface/safe location (such as a bassinet, crib, cradle, or play yard vs. an adult bed).
Parents were asked to report sleep practices at sleep onset and at nighttime waking, and the researchers used a composite score to determine safe practices were met at each of these two time points.
Of the 1,500 participants, 581 (39%), reported any second-sleep practice. Of the 482 who reported on all three sleep practices at both time points, 29% met all three safe sleep criteria at sleep onset and 9% met all three safe sleep criteria at sleep onset and nighttime waking.
Of the parents who reported second sleep practices, 39% reported changes in practice after nighttime waking from sleep onset. Significantly more parents who switched practices between sleep onset and nighttime waking shifted from a safer to a less safe practice, the researchers noted.
For positioning, 67% of respondents overall reported placing infants on their backs at sleep onset. Among the 564 who reported a second sleep position, 42% placed infants on their backs again; 13% switched from supine to nonsupine positions and 7% changed from nonsupine to supine.
For sleep spaces, 72% of participants overall reported a separate sleep space for infants at sleep onset. Of the 508 who reported on second-sleep spaces, 54% kept infants in a separate space after nighttime waking, 18% shifted to a shared space after nighttime waking. Of those in shared spaces at sleep onset, 8% shifted to separate spaces after nighttime waking.
For sleep location, 71% of respondents overall used an approved sleep surface at sleep onset. Of the 560 who reported sleep location at both time points, 42% remained in a safe location after nighttime waking, while 30% were moved from a safe to an unsafe location, and 10% of those in an unsafe location were moved from an unsafe to a safe location.
In a multivariate analysis, the researchers examined the demographics associated with changes in sleep practice after nighttime waking. Parents younger than 25 years, first-time parents, those who identified as Black non-Hispanic or Hispanic, smokers, and those with preterm infants (less than 37 weeks’ gestation) were more likely to change sleep practices after nighttime waking. However, parents who reported a safe sleep practice at sleep onset were more likely to do so after nighttime waking.
“We hypothesize that expansion of existing strategies to promote infant safe sleep practices to include sleep practices after nighttime waking can have a positive impact on infant safe sleep,” the researchers wrote.
The study findings were limited by several factors including the use of an online survey, which limited the study population to those with internet and computer access, and the reliance on self-reports and only two time points, the researchers noted. Other limitations included the inclusion of only three of the AAP sleep recommendations, and the inclusion of only English speakers.
However, the results were strengthened by the large, diverse, and geographically representative sample of parents.
“When advising families about infant sleep, pediatricians should discuss nighttime wakings with parents because they are common and reinforce the need for safe sleep practices every time,” the researchers noted.
Increase opportunities for education
The current study is important because infants continue to die or experience life-long catastrophic health outcomes as a result of not following safe sleep practices, Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.
“I am not surprised by the study findings,” said Dr. Haut, who was not involved in the study. “As a pediatric nurse practitioner for over 35 years, I see infant sleep as a continuing challenge for families. In today’s fast-paced world, multiple priorities leave parents few resources for managing their own well-being, with adequate sleep being one health requirement that is often not met for them.”
To improve safe sleep practices, “it is imperative for health care providers in any setting to address safe sleep practices for infants and children,” said Dr. Haut. “In addition to safety, opportunity for adequate hours of sleep is also important.” She acknowledged that, “in the office setting, time is a huge barrier to completing comprehensive anticipatory guidance. When parents ask questions about sleep, they are often doing everything they can to physically make it through the night with a crying infant. Enforcing safe practices at this point is extremely difficult.”
However, some opportunities for safe sleep education include the prenatal period when parents can take time to listen and plan, not just for feeding preferences but for safe infant sleep practices, Dr. Haut noted.
“When sleep is a problem, families can be invited back to the office for additional counseling and education, which allows more time than within a scheduled health visit,” Dr. Haut emphasized. “Finally, enhanced public awareness is an aspect of learning. In my career I have seen the devastating results of suffocation while cosleeping as well as injuries from falling from a bed or inappropriate sleeping space, and other poor outcomes from inadequate support for safe sleep habits.”
As for additional research, studies are needed to include larger populations and “to further quantify positive outcomes of following safe sleeping practices,” said Dr. Haut. The results of these studies should be made available to the general public, not only to health care professionals.
The study was supported by Seattle Children’s Research Institute. The researchers had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Less than 10% of parents followed recommended safe sleep practices for their infants aged 12 months and younger at both sleep onset and after nighttime waking, based on data from a survey of 1,500 parents published in Pediatrics.
Sleep-related death remains a major cause of infant mortality in the United States despite the early success of public health campaigns for safe sleep practices, such as “Back to Sleep,” and many parents persist in unsafe practices such as prone positioning and bed-sharing, Mersine A. Bryan, MD, of the University of Washington, Seattle, and colleagues wrote. “Though nighttime waking is common for infants, less attention has been paid to the safety of second-sleep practices.”
To examine the prevalence and safety of infant second-sleep practices, the researchers used a cross-sectional online survey to collect information on sleep practices from parents of infants aged 12 months and younger; 74% of the respondents were female, 65% were White, 12% were Black, and 17% were Hispanic. The mean age of the infants was 6.6 months, and 24% were aged 3 months and younger.
The survey included parent reports of three safe sleep practices based on the American Academy of Pediatrics 2016 Safe Infant Sleep Guidelines: supine infant sleep position, use of a separate sleep space (vs. bed sharing), and use of an approved surface/safe location (such as a bassinet, crib, cradle, or play yard vs. an adult bed).
Parents were asked to report sleep practices at sleep onset and at nighttime waking, and the researchers used a composite score to determine safe practices were met at each of these two time points.
Of the 1,500 participants, 581 (39%), reported any second-sleep practice. Of the 482 who reported on all three sleep practices at both time points, 29% met all three safe sleep criteria at sleep onset and 9% met all three safe sleep criteria at sleep onset and nighttime waking.
Of the parents who reported second sleep practices, 39% reported changes in practice after nighttime waking from sleep onset. Significantly more parents who switched practices between sleep onset and nighttime waking shifted from a safer to a less safe practice, the researchers noted.
For positioning, 67% of respondents overall reported placing infants on their backs at sleep onset. Among the 564 who reported a second sleep position, 42% placed infants on their backs again; 13% switched from supine to nonsupine positions and 7% changed from nonsupine to supine.
For sleep spaces, 72% of participants overall reported a separate sleep space for infants at sleep onset. Of the 508 who reported on second-sleep spaces, 54% kept infants in a separate space after nighttime waking, 18% shifted to a shared space after nighttime waking. Of those in shared spaces at sleep onset, 8% shifted to separate spaces after nighttime waking.
For sleep location, 71% of respondents overall used an approved sleep surface at sleep onset. Of the 560 who reported sleep location at both time points, 42% remained in a safe location after nighttime waking, while 30% were moved from a safe to an unsafe location, and 10% of those in an unsafe location were moved from an unsafe to a safe location.
In a multivariate analysis, the researchers examined the demographics associated with changes in sleep practice after nighttime waking. Parents younger than 25 years, first-time parents, those who identified as Black non-Hispanic or Hispanic, smokers, and those with preterm infants (less than 37 weeks’ gestation) were more likely to change sleep practices after nighttime waking. However, parents who reported a safe sleep practice at sleep onset were more likely to do so after nighttime waking.
“We hypothesize that expansion of existing strategies to promote infant safe sleep practices to include sleep practices after nighttime waking can have a positive impact on infant safe sleep,” the researchers wrote.
The study findings were limited by several factors including the use of an online survey, which limited the study population to those with internet and computer access, and the reliance on self-reports and only two time points, the researchers noted. Other limitations included the inclusion of only three of the AAP sleep recommendations, and the inclusion of only English speakers.
However, the results were strengthened by the large, diverse, and geographically representative sample of parents.
“When advising families about infant sleep, pediatricians should discuss nighttime wakings with parents because they are common and reinforce the need for safe sleep practices every time,” the researchers noted.
Increase opportunities for education
The current study is important because infants continue to die or experience life-long catastrophic health outcomes as a result of not following safe sleep practices, Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.
“I am not surprised by the study findings,” said Dr. Haut, who was not involved in the study. “As a pediatric nurse practitioner for over 35 years, I see infant sleep as a continuing challenge for families. In today’s fast-paced world, multiple priorities leave parents few resources for managing their own well-being, with adequate sleep being one health requirement that is often not met for them.”
To improve safe sleep practices, “it is imperative for health care providers in any setting to address safe sleep practices for infants and children,” said Dr. Haut. “In addition to safety, opportunity for adequate hours of sleep is also important.” She acknowledged that, “in the office setting, time is a huge barrier to completing comprehensive anticipatory guidance. When parents ask questions about sleep, they are often doing everything they can to physically make it through the night with a crying infant. Enforcing safe practices at this point is extremely difficult.”
However, some opportunities for safe sleep education include the prenatal period when parents can take time to listen and plan, not just for feeding preferences but for safe infant sleep practices, Dr. Haut noted.
“When sleep is a problem, families can be invited back to the office for additional counseling and education, which allows more time than within a scheduled health visit,” Dr. Haut emphasized. “Finally, enhanced public awareness is an aspect of learning. In my career I have seen the devastating results of suffocation while cosleeping as well as injuries from falling from a bed or inappropriate sleeping space, and other poor outcomes from inadequate support for safe sleep habits.”
As for additional research, studies are needed to include larger populations and “to further quantify positive outcomes of following safe sleeping practices,” said Dr. Haut. The results of these studies should be made available to the general public, not only to health care professionals.
The study was supported by Seattle Children’s Research Institute. The researchers had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Less than 10% of parents followed recommended safe sleep practices for their infants aged 12 months and younger at both sleep onset and after nighttime waking, based on data from a survey of 1,500 parents published in Pediatrics.
Sleep-related death remains a major cause of infant mortality in the United States despite the early success of public health campaigns for safe sleep practices, such as “Back to Sleep,” and many parents persist in unsafe practices such as prone positioning and bed-sharing, Mersine A. Bryan, MD, of the University of Washington, Seattle, and colleagues wrote. “Though nighttime waking is common for infants, less attention has been paid to the safety of second-sleep practices.”
To examine the prevalence and safety of infant second-sleep practices, the researchers used a cross-sectional online survey to collect information on sleep practices from parents of infants aged 12 months and younger; 74% of the respondents were female, 65% were White, 12% were Black, and 17% were Hispanic. The mean age of the infants was 6.6 months, and 24% were aged 3 months and younger.
The survey included parent reports of three safe sleep practices based on the American Academy of Pediatrics 2016 Safe Infant Sleep Guidelines: supine infant sleep position, use of a separate sleep space (vs. bed sharing), and use of an approved surface/safe location (such as a bassinet, crib, cradle, or play yard vs. an adult bed).
Parents were asked to report sleep practices at sleep onset and at nighttime waking, and the researchers used a composite score to determine safe practices were met at each of these two time points.
Of the 1,500 participants, 581 (39%), reported any second-sleep practice. Of the 482 who reported on all three sleep practices at both time points, 29% met all three safe sleep criteria at sleep onset and 9% met all three safe sleep criteria at sleep onset and nighttime waking.
Of the parents who reported second sleep practices, 39% reported changes in practice after nighttime waking from sleep onset. Significantly more parents who switched practices between sleep onset and nighttime waking shifted from a safer to a less safe practice, the researchers noted.
For positioning, 67% of respondents overall reported placing infants on their backs at sleep onset. Among the 564 who reported a second sleep position, 42% placed infants on their backs again; 13% switched from supine to nonsupine positions and 7% changed from nonsupine to supine.
For sleep spaces, 72% of participants overall reported a separate sleep space for infants at sleep onset. Of the 508 who reported on second-sleep spaces, 54% kept infants in a separate space after nighttime waking, 18% shifted to a shared space after nighttime waking. Of those in shared spaces at sleep onset, 8% shifted to separate spaces after nighttime waking.
For sleep location, 71% of respondents overall used an approved sleep surface at sleep onset. Of the 560 who reported sleep location at both time points, 42% remained in a safe location after nighttime waking, while 30% were moved from a safe to an unsafe location, and 10% of those in an unsafe location were moved from an unsafe to a safe location.
In a multivariate analysis, the researchers examined the demographics associated with changes in sleep practice after nighttime waking. Parents younger than 25 years, first-time parents, those who identified as Black non-Hispanic or Hispanic, smokers, and those with preterm infants (less than 37 weeks’ gestation) were more likely to change sleep practices after nighttime waking. However, parents who reported a safe sleep practice at sleep onset were more likely to do so after nighttime waking.
“We hypothesize that expansion of existing strategies to promote infant safe sleep practices to include sleep practices after nighttime waking can have a positive impact on infant safe sleep,” the researchers wrote.
The study findings were limited by several factors including the use of an online survey, which limited the study population to those with internet and computer access, and the reliance on self-reports and only two time points, the researchers noted. Other limitations included the inclusion of only three of the AAP sleep recommendations, and the inclusion of only English speakers.
However, the results were strengthened by the large, diverse, and geographically representative sample of parents.
“When advising families about infant sleep, pediatricians should discuss nighttime wakings with parents because they are common and reinforce the need for safe sleep practices every time,” the researchers noted.
Increase opportunities for education
The current study is important because infants continue to die or experience life-long catastrophic health outcomes as a result of not following safe sleep practices, Cathy Haut, DNP, CPNP-AC, CPNP-PC, a pediatric nurse practitioner in Rehoboth Beach, Del., said in an interview.
“I am not surprised by the study findings,” said Dr. Haut, who was not involved in the study. “As a pediatric nurse practitioner for over 35 years, I see infant sleep as a continuing challenge for families. In today’s fast-paced world, multiple priorities leave parents few resources for managing their own well-being, with adequate sleep being one health requirement that is often not met for them.”
To improve safe sleep practices, “it is imperative for health care providers in any setting to address safe sleep practices for infants and children,” said Dr. Haut. “In addition to safety, opportunity for adequate hours of sleep is also important.” She acknowledged that, “in the office setting, time is a huge barrier to completing comprehensive anticipatory guidance. When parents ask questions about sleep, they are often doing everything they can to physically make it through the night with a crying infant. Enforcing safe practices at this point is extremely difficult.”
However, some opportunities for safe sleep education include the prenatal period when parents can take time to listen and plan, not just for feeding preferences but for safe infant sleep practices, Dr. Haut noted.
“When sleep is a problem, families can be invited back to the office for additional counseling and education, which allows more time than within a scheduled health visit,” Dr. Haut emphasized. “Finally, enhanced public awareness is an aspect of learning. In my career I have seen the devastating results of suffocation while cosleeping as well as injuries from falling from a bed or inappropriate sleeping space, and other poor outcomes from inadequate support for safe sleep habits.”
As for additional research, studies are needed to include larger populations and “to further quantify positive outcomes of following safe sleeping practices,” said Dr. Haut. The results of these studies should be made available to the general public, not only to health care professionals.
The study was supported by Seattle Children’s Research Institute. The researchers had no financial conflicts to disclose. Dr. Haut had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
FROM PEDIATRICS
Phase-3 study: Leukemia patients live longer with ibrutinib
“This trial led to the first-line approval of ibrutinib for CLL patients,” lead author Paul M. Barr, MD, of the University of Rochester (N.Y.), said in an interview. “It is important to follow these patients long-term to understand the expected duration of response/disease control and to monitor for late toxicity,” he said “The data are useful in guiding clinicians who treat CLL and patients being treated with single agent BTK inhibitors,” he noted.
In the initial RESONATE-2, a phase 3, open-label study, 269 adults aged 65 years and older who were previously untreated for CLL or small lymphocytic leukemia were randomized to ibrutinib or the standard of care, chlorambucil. Patients received 420 mg of ibrutinib once daily until disease progression or unacceptable toxicity (136 patients) or up to 12 cycles of 0.5-0.8 mg/kg of chlorambucil (133 patients).
The long-term outcome data were published in Blood Advances.
Overall, at a median of 83 months’ follow-up, progression-free survival was significantly higher for ibrutinib patients than for chlorambucil patients (hazard ratio 0.154).
At 7 years, progression-free survival was 59% in the ibrutinib group vs. 9% in the chlorambucil group.
Notably, progression-free survival benefits with ibrutinib also were higher for patients with high-risk genomic features, identified as del(11q) and unmutated immunoglobulin heavy-chain variable region gene (IGHV).
Complete data were available for 54 patients with del(11q) and 118 with unmutated IGHV. In this subset of patients, progression-free survival rates at 7 years were significantly higher for those treated with ibrutinib vs. chlorambucil who had del(11q) or unmutated IGHV (52% vs. 0% and 58% vs. 2%, respectively).
Approximately 42% of patients with chronic lymphocytic leukemia treated with ibrutinib remained on the therapy at up to 8 years, with a median follow-up of 7.4 years. Overall survival at 7 years was 78% for ibrutinib; overall survival data were not collected for chlorambucil for patients with progressive disease after the median of 5 years, as these patients were eligible to switch to ibrutinib in a long-term extension study or exit the study.
Adverse events prompted reduction of ibrutinib in 30 patients and dose holding for at least 7 days in 79 patients. However, dose modification resolved or improved the adverse events in 85% of the patients with held doses and 90% of those with reduced doses.
The overall prevalence of adverse events was similar to previous follow-up data at 5 years. No new safety signals were observed during the longer study period. The rate of treatment discontinuation because of adverse events was highest in the first year.
“We have been surprised at how long the remissions have lasted with ibrutinib,” said Dr. Barr. “Even with up to 8 years of follow-up, we have yet to reach the median progression free-survival,” he noted.
“These data, in combination with other data sets, highlight the impact that ibrutinib and other BTK inhibitors have had in treating CLL,” said Dr. Barr. “Patients are living longer and avoiding the side effects of chemotherapy in the era of novel agent use,” he said.
However, research gaps remain, Dr. Barr noted. “We need to continue following these patients over time given the length of the remissions. Additionally, we need to continue investigating novel combinations,” he said. Such studies will help us understand the benefit of fixed durations regimens compared to single agent BTK inhibitors,” he emphasized.
Safety and efficacy remain promising
“Ibrutinib was approved for the treatment of CLL, but only in the relapsed setting,” Susan M. O’Brien, MD, of the University of California, Irvine, said in an interview. “This trial was important because it led to the approval of ibrutinib in the front-line setting, making it the first, and at the time, only, small molecule that could be used upfront,” said Dr. O’Brien, who was not involved with the study.
“The initial results were certainly not surprising, as given the efficacy of ibrutinib in the relapsed setting, it seemed likely that it would produce a longer PFS than chlorambucil,” said Dr. O’Brien. “What may not have been expected though, is the incredible durability of these responses with ibrutinib,” she noted.
The clinical implications of the long-term data are that ibrutinib is producing “very durable remissions with continuous therapy,” Dr. O’Brien said. “There are no late safety signals and most side effects diminish with time. However, hypertension and atrial fibrillation continue to occur, so continued monitoring of blood pressure in these patients is important,” she emphasized.
Minor, but annoying, side effects are not infrequent early on with ibrutinib and may present a barrier to use for some patients, Dr. O’Brien said. “Some side effects may be overcome with temporary pauses of drug or dose reduction,” she noted. However, “it is important for patients to be aware that most of these side effects will completely abate with time,” she added.
“The main limitation of this trial was that the comparison was to a rather weak chemotherapy agent, albeit it one frequently used in older patients, particularly in Europe,” said Dr. O’Brien. “Nevertheless, two subsequent trials comparing ibrutinib (with or without rituximab) with either BR [bendamustine/rituximab] or FCR [fludarabine/cyclophosphamide/rituximab] showed a longer PFS with ibrutinib, as compared to that seen with either chemoimmunotherapy regimen,” she said.
The study was supported by Pharmacyclics LLC, an AbbVie company. Dr. Barr collaborated with sponsor AbbVie on the study design, and disclosed relationships with companies including AbbVie, AstraZeneca, Bristol Myers Squibb, Celgene, Genentech, Gilead, Janssen, MEI Pharma, Merck, Morphosys, Pharmacyclics LLC (an AbbVie company), Seattle Genetics, and TG Therapeutics. Dr. O’Brien had no relevant financial conflicts to disclose.
“This trial led to the first-line approval of ibrutinib for CLL patients,” lead author Paul M. Barr, MD, of the University of Rochester (N.Y.), said in an interview. “It is important to follow these patients long-term to understand the expected duration of response/disease control and to monitor for late toxicity,” he said “The data are useful in guiding clinicians who treat CLL and patients being treated with single agent BTK inhibitors,” he noted.
In the initial RESONATE-2, a phase 3, open-label study, 269 adults aged 65 years and older who were previously untreated for CLL or small lymphocytic leukemia were randomized to ibrutinib or the standard of care, chlorambucil. Patients received 420 mg of ibrutinib once daily until disease progression or unacceptable toxicity (136 patients) or up to 12 cycles of 0.5-0.8 mg/kg of chlorambucil (133 patients).
The long-term outcome data were published in Blood Advances.
Overall, at a median of 83 months’ follow-up, progression-free survival was significantly higher for ibrutinib patients than for chlorambucil patients (hazard ratio 0.154).
At 7 years, progression-free survival was 59% in the ibrutinib group vs. 9% in the chlorambucil group.
Notably, progression-free survival benefits with ibrutinib also were higher for patients with high-risk genomic features, identified as del(11q) and unmutated immunoglobulin heavy-chain variable region gene (IGHV).
Complete data were available for 54 patients with del(11q) and 118 with unmutated IGHV. In this subset of patients, progression-free survival rates at 7 years were significantly higher for those treated with ibrutinib vs. chlorambucil who had del(11q) or unmutated IGHV (52% vs. 0% and 58% vs. 2%, respectively).
Approximately 42% of patients with chronic lymphocytic leukemia treated with ibrutinib remained on the therapy at up to 8 years, with a median follow-up of 7.4 years. Overall survival at 7 years was 78% for ibrutinib; overall survival data were not collected for chlorambucil for patients with progressive disease after the median of 5 years, as these patients were eligible to switch to ibrutinib in a long-term extension study or exit the study.
Adverse events prompted reduction of ibrutinib in 30 patients and dose holding for at least 7 days in 79 patients. However, dose modification resolved or improved the adverse events in 85% of the patients with held doses and 90% of those with reduced doses.
The overall prevalence of adverse events was similar to previous follow-up data at 5 years. No new safety signals were observed during the longer study period. The rate of treatment discontinuation because of adverse events was highest in the first year.
“We have been surprised at how long the remissions have lasted with ibrutinib,” said Dr. Barr. “Even with up to 8 years of follow-up, we have yet to reach the median progression free-survival,” he noted.
“These data, in combination with other data sets, highlight the impact that ibrutinib and other BTK inhibitors have had in treating CLL,” said Dr. Barr. “Patients are living longer and avoiding the side effects of chemotherapy in the era of novel agent use,” he said.
However, research gaps remain, Dr. Barr noted. “We need to continue following these patients over time given the length of the remissions. Additionally, we need to continue investigating novel combinations,” he said. Such studies will help us understand the benefit of fixed durations regimens compared to single agent BTK inhibitors,” he emphasized.
Safety and efficacy remain promising
“Ibrutinib was approved for the treatment of CLL, but only in the relapsed setting,” Susan M. O’Brien, MD, of the University of California, Irvine, said in an interview. “This trial was important because it led to the approval of ibrutinib in the front-line setting, making it the first, and at the time, only, small molecule that could be used upfront,” said Dr. O’Brien, who was not involved with the study.
“The initial results were certainly not surprising, as given the efficacy of ibrutinib in the relapsed setting, it seemed likely that it would produce a longer PFS than chlorambucil,” said Dr. O’Brien. “What may not have been expected though, is the incredible durability of these responses with ibrutinib,” she noted.
The clinical implications of the long-term data are that ibrutinib is producing “very durable remissions with continuous therapy,” Dr. O’Brien said. “There are no late safety signals and most side effects diminish with time. However, hypertension and atrial fibrillation continue to occur, so continued monitoring of blood pressure in these patients is important,” she emphasized.
Minor, but annoying, side effects are not infrequent early on with ibrutinib and may present a barrier to use for some patients, Dr. O’Brien said. “Some side effects may be overcome with temporary pauses of drug or dose reduction,” she noted. However, “it is important for patients to be aware that most of these side effects will completely abate with time,” she added.
“The main limitation of this trial was that the comparison was to a rather weak chemotherapy agent, albeit it one frequently used in older patients, particularly in Europe,” said Dr. O’Brien. “Nevertheless, two subsequent trials comparing ibrutinib (with or without rituximab) with either BR [bendamustine/rituximab] or FCR [fludarabine/cyclophosphamide/rituximab] showed a longer PFS with ibrutinib, as compared to that seen with either chemoimmunotherapy regimen,” she said.
The study was supported by Pharmacyclics LLC, an AbbVie company. Dr. Barr collaborated with sponsor AbbVie on the study design, and disclosed relationships with companies including AbbVie, AstraZeneca, Bristol Myers Squibb, Celgene, Genentech, Gilead, Janssen, MEI Pharma, Merck, Morphosys, Pharmacyclics LLC (an AbbVie company), Seattle Genetics, and TG Therapeutics. Dr. O’Brien had no relevant financial conflicts to disclose.
“This trial led to the first-line approval of ibrutinib for CLL patients,” lead author Paul M. Barr, MD, of the University of Rochester (N.Y.), said in an interview. “It is important to follow these patients long-term to understand the expected duration of response/disease control and to monitor for late toxicity,” he said “The data are useful in guiding clinicians who treat CLL and patients being treated with single agent BTK inhibitors,” he noted.
In the initial RESONATE-2, a phase 3, open-label study, 269 adults aged 65 years and older who were previously untreated for CLL or small lymphocytic leukemia were randomized to ibrutinib or the standard of care, chlorambucil. Patients received 420 mg of ibrutinib once daily until disease progression or unacceptable toxicity (136 patients) or up to 12 cycles of 0.5-0.8 mg/kg of chlorambucil (133 patients).
The long-term outcome data were published in Blood Advances.
Overall, at a median of 83 months’ follow-up, progression-free survival was significantly higher for ibrutinib patients than for chlorambucil patients (hazard ratio 0.154).
At 7 years, progression-free survival was 59% in the ibrutinib group vs. 9% in the chlorambucil group.
Notably, progression-free survival benefits with ibrutinib also were higher for patients with high-risk genomic features, identified as del(11q) and unmutated immunoglobulin heavy-chain variable region gene (IGHV).
Complete data were available for 54 patients with del(11q) and 118 with unmutated IGHV. In this subset of patients, progression-free survival rates at 7 years were significantly higher for those treated with ibrutinib vs. chlorambucil who had del(11q) or unmutated IGHV (52% vs. 0% and 58% vs. 2%, respectively).
Approximately 42% of patients with chronic lymphocytic leukemia treated with ibrutinib remained on the therapy at up to 8 years, with a median follow-up of 7.4 years. Overall survival at 7 years was 78% for ibrutinib; overall survival data were not collected for chlorambucil for patients with progressive disease after the median of 5 years, as these patients were eligible to switch to ibrutinib in a long-term extension study or exit the study.
Adverse events prompted reduction of ibrutinib in 30 patients and dose holding for at least 7 days in 79 patients. However, dose modification resolved or improved the adverse events in 85% of the patients with held doses and 90% of those with reduced doses.
The overall prevalence of adverse events was similar to previous follow-up data at 5 years. No new safety signals were observed during the longer study period. The rate of treatment discontinuation because of adverse events was highest in the first year.
“We have been surprised at how long the remissions have lasted with ibrutinib,” said Dr. Barr. “Even with up to 8 years of follow-up, we have yet to reach the median progression free-survival,” he noted.
“These data, in combination with other data sets, highlight the impact that ibrutinib and other BTK inhibitors have had in treating CLL,” said Dr. Barr. “Patients are living longer and avoiding the side effects of chemotherapy in the era of novel agent use,” he said.
However, research gaps remain, Dr. Barr noted. “We need to continue following these patients over time given the length of the remissions. Additionally, we need to continue investigating novel combinations,” he said. Such studies will help us understand the benefit of fixed durations regimens compared to single agent BTK inhibitors,” he emphasized.
Safety and efficacy remain promising
“Ibrutinib was approved for the treatment of CLL, but only in the relapsed setting,” Susan M. O’Brien, MD, of the University of California, Irvine, said in an interview. “This trial was important because it led to the approval of ibrutinib in the front-line setting, making it the first, and at the time, only, small molecule that could be used upfront,” said Dr. O’Brien, who was not involved with the study.
“The initial results were certainly not surprising, as given the efficacy of ibrutinib in the relapsed setting, it seemed likely that it would produce a longer PFS than chlorambucil,” said Dr. O’Brien. “What may not have been expected though, is the incredible durability of these responses with ibrutinib,” she noted.
The clinical implications of the long-term data are that ibrutinib is producing “very durable remissions with continuous therapy,” Dr. O’Brien said. “There are no late safety signals and most side effects diminish with time. However, hypertension and atrial fibrillation continue to occur, so continued monitoring of blood pressure in these patients is important,” she emphasized.
Minor, but annoying, side effects are not infrequent early on with ibrutinib and may present a barrier to use for some patients, Dr. O’Brien said. “Some side effects may be overcome with temporary pauses of drug or dose reduction,” she noted. However, “it is important for patients to be aware that most of these side effects will completely abate with time,” she added.
“The main limitation of this trial was that the comparison was to a rather weak chemotherapy agent, albeit it one frequently used in older patients, particularly in Europe,” said Dr. O’Brien. “Nevertheless, two subsequent trials comparing ibrutinib (with or without rituximab) with either BR [bendamustine/rituximab] or FCR [fludarabine/cyclophosphamide/rituximab] showed a longer PFS with ibrutinib, as compared to that seen with either chemoimmunotherapy regimen,” she said.
The study was supported by Pharmacyclics LLC, an AbbVie company. Dr. Barr collaborated with sponsor AbbVie on the study design, and disclosed relationships with companies including AbbVie, AstraZeneca, Bristol Myers Squibb, Celgene, Genentech, Gilead, Janssen, MEI Pharma, Merck, Morphosys, Pharmacyclics LLC (an AbbVie company), Seattle Genetics, and TG Therapeutics. Dr. O’Brien had no relevant financial conflicts to disclose.
FROM BLOOD ADVANCES
FDA approves topical tapinarof for plaque psoriasis
The the manufacturer announced.
Tapinarof is an aryl hydrocarbon receptor agonist and is the first FDA-approved steroid-free topical medication in this class, according to a press release from the manufacturer, Dermavant.
Approval was based on results of three studies in a phase 3 clinical trial program (PSOARING 1, PSOARING 2), and an open-label extension study, (PSOARING 3), the company release said. In PSOARING 1 and 2, approximately 1,000 adults aged 18-75 years (median age, 51 years) with plaque psoriasis were randomized to once-daily topical tapinarof or placebo for up to 12 weeks; 85% were White and 57% were men. The study findings were published in the New England Journal of Medicine in December 2021.
The primary endpoint for both trials was the proportion of patients who achieved Physician Global Assessment (PGA) scores score of “clear” (0) or “almost clear” (1) and improvement of at least two grades from baseline.
After 12 weeks, 36% of the patients in PSOARING 1 and 40% in PSOARING 2 who received tapinarof met the primary outcome, compared with 6% of patients on placebo (P < .001 for both studies). Of these, a total of 73 patients from both studies who achieved PGA scores of 0 were entered in PSOARING 3, a 40-week open-label extension study, in which they stopped tapinarof treatment and retained PGA scores of 0 or 1 for approximately 4 months off treatment. An additional 312 patients who were enrolled in the PSOARING 3 extension study achieved PGA scores of 0 at least once during the study period, with “remittive” effects lasting a mean of 130 days off of treatment.
In addition, patients who received tapinarof in the PSOARING 1 and 2 studies showed significant improvement from baseline, compared with patients on placebo, across a range of secondary endpoints including a 75% or greater improvement in Psoriasis Area and Severity Index score (PASI 75).
In PSOARING 1, and 2, respectively, 36.1% and 47.6% of those on tapinarof achieved a PASI 75 response at week 12, compared with 10.2% and 6.9% of those on the vehicle (P < .001 for both).
Across all three studies, the majority adverse events were mild to moderate, and limited to the application site.
The most common adverse events reported by patients in the tapinarof groups were folliculitis, nasopharyngitis, and contact dermatitis. Headaches were more common among those treated with tapinarof than those on vehicle in the studies (3.8% vs. 2.4% in PSOARING 1, and 3.8% vs. 0.6% in PSOARING 2), leading to only three treatment discontinuations.
At the end of the PSOARING 3 study (at either week 40 or early termination), 599 participants responded to satisfaction questionnaires. Of these, 83.6% said they were satisfied with the results of tapinarof treatment, and 81.7% said it was more effective than previous topical treatments they had used, according to the company’s release.
Tapinarof cream can be used on all areas of the body, including the face, skin folds, neck, genitalia, anal crux, inflammatory areas, and axillae, according to the company release.
Full prescribing information is available here.
The the manufacturer announced.
Tapinarof is an aryl hydrocarbon receptor agonist and is the first FDA-approved steroid-free topical medication in this class, according to a press release from the manufacturer, Dermavant.
Approval was based on results of three studies in a phase 3 clinical trial program (PSOARING 1, PSOARING 2), and an open-label extension study, (PSOARING 3), the company release said. In PSOARING 1 and 2, approximately 1,000 adults aged 18-75 years (median age, 51 years) with plaque psoriasis were randomized to once-daily topical tapinarof or placebo for up to 12 weeks; 85% were White and 57% were men. The study findings were published in the New England Journal of Medicine in December 2021.
The primary endpoint for both trials was the proportion of patients who achieved Physician Global Assessment (PGA) scores score of “clear” (0) or “almost clear” (1) and improvement of at least two grades from baseline.
After 12 weeks, 36% of the patients in PSOARING 1 and 40% in PSOARING 2 who received tapinarof met the primary outcome, compared with 6% of patients on placebo (P < .001 for both studies). Of these, a total of 73 patients from both studies who achieved PGA scores of 0 were entered in PSOARING 3, a 40-week open-label extension study, in which they stopped tapinarof treatment and retained PGA scores of 0 or 1 for approximately 4 months off treatment. An additional 312 patients who were enrolled in the PSOARING 3 extension study achieved PGA scores of 0 at least once during the study period, with “remittive” effects lasting a mean of 130 days off of treatment.
In addition, patients who received tapinarof in the PSOARING 1 and 2 studies showed significant improvement from baseline, compared with patients on placebo, across a range of secondary endpoints including a 75% or greater improvement in Psoriasis Area and Severity Index score (PASI 75).
In PSOARING 1, and 2, respectively, 36.1% and 47.6% of those on tapinarof achieved a PASI 75 response at week 12, compared with 10.2% and 6.9% of those on the vehicle (P < .001 for both).
Across all three studies, the majority adverse events were mild to moderate, and limited to the application site.
The most common adverse events reported by patients in the tapinarof groups were folliculitis, nasopharyngitis, and contact dermatitis. Headaches were more common among those treated with tapinarof than those on vehicle in the studies (3.8% vs. 2.4% in PSOARING 1, and 3.8% vs. 0.6% in PSOARING 2), leading to only three treatment discontinuations.
At the end of the PSOARING 3 study (at either week 40 or early termination), 599 participants responded to satisfaction questionnaires. Of these, 83.6% said they were satisfied with the results of tapinarof treatment, and 81.7% said it was more effective than previous topical treatments they had used, according to the company’s release.
Tapinarof cream can be used on all areas of the body, including the face, skin folds, neck, genitalia, anal crux, inflammatory areas, and axillae, according to the company release.
Full prescribing information is available here.
The the manufacturer announced.
Tapinarof is an aryl hydrocarbon receptor agonist and is the first FDA-approved steroid-free topical medication in this class, according to a press release from the manufacturer, Dermavant.
Approval was based on results of three studies in a phase 3 clinical trial program (PSOARING 1, PSOARING 2), and an open-label extension study, (PSOARING 3), the company release said. In PSOARING 1 and 2, approximately 1,000 adults aged 18-75 years (median age, 51 years) with plaque psoriasis were randomized to once-daily topical tapinarof or placebo for up to 12 weeks; 85% were White and 57% were men. The study findings were published in the New England Journal of Medicine in December 2021.
The primary endpoint for both trials was the proportion of patients who achieved Physician Global Assessment (PGA) scores score of “clear” (0) or “almost clear” (1) and improvement of at least two grades from baseline.
After 12 weeks, 36% of the patients in PSOARING 1 and 40% in PSOARING 2 who received tapinarof met the primary outcome, compared with 6% of patients on placebo (P < .001 for both studies). Of these, a total of 73 patients from both studies who achieved PGA scores of 0 were entered in PSOARING 3, a 40-week open-label extension study, in which they stopped tapinarof treatment and retained PGA scores of 0 or 1 for approximately 4 months off treatment. An additional 312 patients who were enrolled in the PSOARING 3 extension study achieved PGA scores of 0 at least once during the study period, with “remittive” effects lasting a mean of 130 days off of treatment.
In addition, patients who received tapinarof in the PSOARING 1 and 2 studies showed significant improvement from baseline, compared with patients on placebo, across a range of secondary endpoints including a 75% or greater improvement in Psoriasis Area and Severity Index score (PASI 75).
In PSOARING 1, and 2, respectively, 36.1% and 47.6% of those on tapinarof achieved a PASI 75 response at week 12, compared with 10.2% and 6.9% of those on the vehicle (P < .001 for both).
Across all three studies, the majority adverse events were mild to moderate, and limited to the application site.
The most common adverse events reported by patients in the tapinarof groups were folliculitis, nasopharyngitis, and contact dermatitis. Headaches were more common among those treated with tapinarof than those on vehicle in the studies (3.8% vs. 2.4% in PSOARING 1, and 3.8% vs. 0.6% in PSOARING 2), leading to only three treatment discontinuations.
At the end of the PSOARING 3 study (at either week 40 or early termination), 599 participants responded to satisfaction questionnaires. Of these, 83.6% said they were satisfied with the results of tapinarof treatment, and 81.7% said it was more effective than previous topical treatments they had used, according to the company’s release.
Tapinarof cream can be used on all areas of the body, including the face, skin folds, neck, genitalia, anal crux, inflammatory areas, and axillae, according to the company release.
Full prescribing information is available here.
Contraceptive use boosted by enhanced counseling
Contraceptive counseling and interventions beyond usual care significantly increased the use of contraceptives with no accompanying increase in sexually transmitted infections or reduction in condom use, based on data from a new meta-analysis.
“Although effective contraception is available in the United States and guidelines support contraceptive care in clinical practice, providing contraceptive care has not been widely adopted across medical specialties as a preventive health service that is routinely offered to eligible patients, such as mammography screening,” lead author Heidi D. Nelson, MD, of Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., said in an interview.
“Access to and coverage of contraceptive care are frequently challenged by legislation and insurance policies, and influential preventive services guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care,” Dr. Nelson said.
“The evidence to determine the benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to those used for other preventive services and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices,” she added.
In a study published in Annals of Internal Medicine, Dr. Nelson and colleagues reviewed data from 38 randomized, controlled trials with a total of 25,472 participants. The trials evaluated the effectiveness of various types of contraceptive counseling and provision interventions beyond usual care on subsequent contraception use, compared with nonintervention comparison groups.
Overall, higher contraceptive use was associated with counseling interventions (risk ratio, 1.39), advance provision of emergency contraception (RR, 2.12), counseling or provision of emergency contraception postpartum (RR, 1.15), or counseling or provision of emergency contraception at the time of abortion (RR, 1.19), compared with usual care or active controls across studies.
Most of the included trials were not powered to distinguish intended versus unintended pregnancy rates, but pregnancy rates were lower among intervention groups, compared with controls.
Five of the selected studies assessed the potential negative effect of contraceptive counseling with regard to increased rates of STIs and two studies examined decreased condom use. However, neither STI rates nor condom use were significantly different between study participants who received various contraceptive counseling interventions (such as advanced provision of emergency contraception, clinician training, and individual counseling) and those who did not (RR, 1.05 and RR, 1.03, respectively).
“These results indicate that additional efforts to assist patients with their contraception decisions improve its subsequent use,” and are not surprising, said Dr. Nelson.
“All clinicians providing health care to women, not only clinicians providing reproductive health care specifically, need to recognize contraceptive care as an essential preventive health service and assume responsibility for delivering contraceptive counseling and provision services appropriate for each patient,” Dr. Nelson emphasized. “Clinicians lacking contraceptive care clinical skills may require additional training or refer their patients if needed to assure high quality care.”
The study findings were limited by several factors including the variability of interventions across studies and the lack of data on unintended pregnancy outcomes, the researchers noted. However, the results suggest that various contraceptive counseling and interventions beyond usual care increased contraceptive use with no reduction in condom use or increase in STIs, they wrote.
“Additional research should further evaluate approaches to contraceptive counseling and provision to determine best practices,” Dr. Nelson said in an interview. “This is particularly important for medically high-risk populations, those with limited access to care, and additional populations and settings that have not yet been studied, including transgender and nonbinary patients. Research is needed to refine measures of pregnancy intention and planning; and create uniform definitions of contraceptive care, interventions, measures of use, and outcomes.”.
Make easy, effective contraception accessible to all
The news of a potential overturn of the 1973 Roe v. Wade Supreme Court decision that protects a pregnant person’s ability to choose abortion “shines a bright light on the importance of promoting the use of contraception,” and on the findings of the current review, Christine Laine, MD, editor-in-chief of Annals of Internal Medicine, wrote in an accompanying editorial. “Easy, effective, accessible, and affordable contraception becomes increasingly essential as ending unintended pregnancy becomes increasingly difficult, unsafe, inaccessible, and legally risky.”
The available evidence showed the benefits of enhanced counseling, providing emergency contraception in advance, and providing contraceptive interventions immediately after delivery or pregnancy termination, she wrote. The findings have strong clinical implications, especially with regard to the Healthy People 2030 goal of reducing unintended pregnancy from the current 43% to 36.5%.
Dr. Laine called on internal medicine physicians in particular to recognize the negative health consequences of unintended pregnancy, and to consider contraceptive counseling part of their responsibility to their patients.
“To expand the numbers of people who receive this essential preventive service, we must systematically incorporate contraceptive counseling into health care with the same fervor that we devote to other preventive services. The health of our patients – and their families – depends on it,” she concluded.
The study was supported by the Resources Legacy Fund. The researchers had no financial conflicts to disclose. Dr. Laine had no financial conflicts to disclose.
Contraceptive counseling and interventions beyond usual care significantly increased the use of contraceptives with no accompanying increase in sexually transmitted infections or reduction in condom use, based on data from a new meta-analysis.
“Although effective contraception is available in the United States and guidelines support contraceptive care in clinical practice, providing contraceptive care has not been widely adopted across medical specialties as a preventive health service that is routinely offered to eligible patients, such as mammography screening,” lead author Heidi D. Nelson, MD, of Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., said in an interview.
“Access to and coverage of contraceptive care are frequently challenged by legislation and insurance policies, and influential preventive services guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care,” Dr. Nelson said.
“The evidence to determine the benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to those used for other preventive services and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices,” she added.
In a study published in Annals of Internal Medicine, Dr. Nelson and colleagues reviewed data from 38 randomized, controlled trials with a total of 25,472 participants. The trials evaluated the effectiveness of various types of contraceptive counseling and provision interventions beyond usual care on subsequent contraception use, compared with nonintervention comparison groups.
Overall, higher contraceptive use was associated with counseling interventions (risk ratio, 1.39), advance provision of emergency contraception (RR, 2.12), counseling or provision of emergency contraception postpartum (RR, 1.15), or counseling or provision of emergency contraception at the time of abortion (RR, 1.19), compared with usual care or active controls across studies.
Most of the included trials were not powered to distinguish intended versus unintended pregnancy rates, but pregnancy rates were lower among intervention groups, compared with controls.
Five of the selected studies assessed the potential negative effect of contraceptive counseling with regard to increased rates of STIs and two studies examined decreased condom use. However, neither STI rates nor condom use were significantly different between study participants who received various contraceptive counseling interventions (such as advanced provision of emergency contraception, clinician training, and individual counseling) and those who did not (RR, 1.05 and RR, 1.03, respectively).
“These results indicate that additional efforts to assist patients with their contraception decisions improve its subsequent use,” and are not surprising, said Dr. Nelson.
“All clinicians providing health care to women, not only clinicians providing reproductive health care specifically, need to recognize contraceptive care as an essential preventive health service and assume responsibility for delivering contraceptive counseling and provision services appropriate for each patient,” Dr. Nelson emphasized. “Clinicians lacking contraceptive care clinical skills may require additional training or refer their patients if needed to assure high quality care.”
The study findings were limited by several factors including the variability of interventions across studies and the lack of data on unintended pregnancy outcomes, the researchers noted. However, the results suggest that various contraceptive counseling and interventions beyond usual care increased contraceptive use with no reduction in condom use or increase in STIs, they wrote.
“Additional research should further evaluate approaches to contraceptive counseling and provision to determine best practices,” Dr. Nelson said in an interview. “This is particularly important for medically high-risk populations, those with limited access to care, and additional populations and settings that have not yet been studied, including transgender and nonbinary patients. Research is needed to refine measures of pregnancy intention and planning; and create uniform definitions of contraceptive care, interventions, measures of use, and outcomes.”.
Make easy, effective contraception accessible to all
The news of a potential overturn of the 1973 Roe v. Wade Supreme Court decision that protects a pregnant person’s ability to choose abortion “shines a bright light on the importance of promoting the use of contraception,” and on the findings of the current review, Christine Laine, MD, editor-in-chief of Annals of Internal Medicine, wrote in an accompanying editorial. “Easy, effective, accessible, and affordable contraception becomes increasingly essential as ending unintended pregnancy becomes increasingly difficult, unsafe, inaccessible, and legally risky.”
The available evidence showed the benefits of enhanced counseling, providing emergency contraception in advance, and providing contraceptive interventions immediately after delivery or pregnancy termination, she wrote. The findings have strong clinical implications, especially with regard to the Healthy People 2030 goal of reducing unintended pregnancy from the current 43% to 36.5%.
Dr. Laine called on internal medicine physicians in particular to recognize the negative health consequences of unintended pregnancy, and to consider contraceptive counseling part of their responsibility to their patients.
“To expand the numbers of people who receive this essential preventive service, we must systematically incorporate contraceptive counseling into health care with the same fervor that we devote to other preventive services. The health of our patients – and their families – depends on it,” she concluded.
The study was supported by the Resources Legacy Fund. The researchers had no financial conflicts to disclose. Dr. Laine had no financial conflicts to disclose.
Contraceptive counseling and interventions beyond usual care significantly increased the use of contraceptives with no accompanying increase in sexually transmitted infections or reduction in condom use, based on data from a new meta-analysis.
“Although effective contraception is available in the United States and guidelines support contraceptive care in clinical practice, providing contraceptive care has not been widely adopted across medical specialties as a preventive health service that is routinely offered to eligible patients, such as mammography screening,” lead author Heidi D. Nelson, MD, of Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif., said in an interview.
“Access to and coverage of contraceptive care are frequently challenged by legislation and insurance policies, and influential preventive services guideline groups, such as the U.S. Preventive Services Task Force, have not issued recommendations for contraceptive care,” Dr. Nelson said.
“The evidence to determine the benefits and harms of contraceptive care as a preventive health service has not been examined using methods similar to those used for other preventive services and clinicians may lack guidance on the effectiveness of contraception services relevant to their practices,” she added.
In a study published in Annals of Internal Medicine, Dr. Nelson and colleagues reviewed data from 38 randomized, controlled trials with a total of 25,472 participants. The trials evaluated the effectiveness of various types of contraceptive counseling and provision interventions beyond usual care on subsequent contraception use, compared with nonintervention comparison groups.
Overall, higher contraceptive use was associated with counseling interventions (risk ratio, 1.39), advance provision of emergency contraception (RR, 2.12), counseling or provision of emergency contraception postpartum (RR, 1.15), or counseling or provision of emergency contraception at the time of abortion (RR, 1.19), compared with usual care or active controls across studies.
Most of the included trials were not powered to distinguish intended versus unintended pregnancy rates, but pregnancy rates were lower among intervention groups, compared with controls.
Five of the selected studies assessed the potential negative effect of contraceptive counseling with regard to increased rates of STIs and two studies examined decreased condom use. However, neither STI rates nor condom use were significantly different between study participants who received various contraceptive counseling interventions (such as advanced provision of emergency contraception, clinician training, and individual counseling) and those who did not (RR, 1.05 and RR, 1.03, respectively).
“These results indicate that additional efforts to assist patients with their contraception decisions improve its subsequent use,” and are not surprising, said Dr. Nelson.
“All clinicians providing health care to women, not only clinicians providing reproductive health care specifically, need to recognize contraceptive care as an essential preventive health service and assume responsibility for delivering contraceptive counseling and provision services appropriate for each patient,” Dr. Nelson emphasized. “Clinicians lacking contraceptive care clinical skills may require additional training or refer their patients if needed to assure high quality care.”
The study findings were limited by several factors including the variability of interventions across studies and the lack of data on unintended pregnancy outcomes, the researchers noted. However, the results suggest that various contraceptive counseling and interventions beyond usual care increased contraceptive use with no reduction in condom use or increase in STIs, they wrote.
“Additional research should further evaluate approaches to contraceptive counseling and provision to determine best practices,” Dr. Nelson said in an interview. “This is particularly important for medically high-risk populations, those with limited access to care, and additional populations and settings that have not yet been studied, including transgender and nonbinary patients. Research is needed to refine measures of pregnancy intention and planning; and create uniform definitions of contraceptive care, interventions, measures of use, and outcomes.”.
Make easy, effective contraception accessible to all
The news of a potential overturn of the 1973 Roe v. Wade Supreme Court decision that protects a pregnant person’s ability to choose abortion “shines a bright light on the importance of promoting the use of contraception,” and on the findings of the current review, Christine Laine, MD, editor-in-chief of Annals of Internal Medicine, wrote in an accompanying editorial. “Easy, effective, accessible, and affordable contraception becomes increasingly essential as ending unintended pregnancy becomes increasingly difficult, unsafe, inaccessible, and legally risky.”
The available evidence showed the benefits of enhanced counseling, providing emergency contraception in advance, and providing contraceptive interventions immediately after delivery or pregnancy termination, she wrote. The findings have strong clinical implications, especially with regard to the Healthy People 2030 goal of reducing unintended pregnancy from the current 43% to 36.5%.
Dr. Laine called on internal medicine physicians in particular to recognize the negative health consequences of unintended pregnancy, and to consider contraceptive counseling part of their responsibility to their patients.
“To expand the numbers of people who receive this essential preventive service, we must systematically incorporate contraceptive counseling into health care with the same fervor that we devote to other preventive services. The health of our patients – and their families – depends on it,” she concluded.
The study was supported by the Resources Legacy Fund. The researchers had no financial conflicts to disclose. Dr. Laine had no financial conflicts to disclose.
FROM ANNALS OF INTERNAL MEDICINE
Cannabis vaping continues its rise in teens
More teenagers in the United States reported cannabis use with vaping in 2019, compared with 2017, while cannabis use without vaping declined, based on annual survey data from more than 50,000 teens.
“With vaping prevalence rising so quickly among teens, getting a clearer picture of how cannabis use is shifting helps inform prevention and cessation efforts,” corresponding author Noah T. Kreski, MPH, of Columbia University, New York, said in an interview.
“In just 2 years, the most common cannabis use pattern changed from ‘occasional use without vaping’ to ‘frequent use with vaping,’ said Mx. Kreski, who uses the honorific Mx. and the pronouns they/them. “Knowing that, as well as the high overlap of cannabis vaping with nicotine use and binge drinking, adds to the urgency of reducing adolescent vaping.”
To quantify the trends in cannabis vaping, the researchers reviewed data from Monitoring the Future, an annual survey of high school students across the United States. The study population included 51,052 individuals; approximately 49% were male and 49% were non-Hispanic White. The researchers examined frequency of cannabis use, trends across demographic groups, and concurrent use of cannabis and other substances such as alcohol and tobacco. The findings were published in the journal Addiction.
Frequent cannabis use was defined as six or more times in the past 30 days; occasional use was defined as one to five times in the past 30 days.
Frequent cannabis use with vaping increased from 2.1% in 2017 to 5.4% in 2019. Occasional cannabis use with vaping also increased, though less dramatically, from less than 2% in 2017 to approximately 3.5% in 2019.
By contrast, both frequent and occasional cannabis use without vaping declined from 2017 to 2019 (from 3.8% to 2.1% and from 6.9% to 4.4%, respectively).
Overall, the prevalence of any level of cannabis use increased from 13.9% in 2017 to 15.4% in 2019. Both males and females showed a similar increase in reported frequent cannabis use with vaping of approximately 3%.
The results document that vaping cannabis has become more common than smoking alone among U.S. teens across almost all demographic groups, and across sex, race, urbanicity, and level of parent education; however, the increased was especially marked among Hispanic/Latinx teens and those of lower socioeconomic status, the researchers wrote.
The researchers also examined the associations between cannabis use with and without vaping and concurrent nicotine and alcohol use. Overall, the strongest association was between smoking or vaping nicotine and vaping cannabis; teens who smoked or vaped nicotine were 42 times more likely than nonnicotine users to report vaping cannabis in the past 30 days (adjusted odds ratio, 42.28). In addition, more occasions of binge drinking were more strongly associated with cannabis use with vaping (up to 10 times more likely), compared with cannabis use without vaping, (aORs, 4.48-10.09).
The study findings were limited by several factors, including the lack of questions on tetrahydrocannabinol (THC) or cannabidiol content of the cannabis products used, although evidence suggests that the potency of cannabis products in the United States is increasing, the researchers noted. Other limitations included the cross-sectional design, which prevents making associations about causality, and lack of data on the quantity of cannabis used; only data on frequency of use were recorded.
However, the results reflect a rise in cannabis use with vaping among teens in the United States, along with an increased risk of tobacco use, e-cigarette use, and binge drinking, the researchers said.
As cannabis legalization expands across the United States, policies are needed to deter use among adolescents, the researchers wrote. “These policies should be crafted to reduce an emphasis on criminalization in preference for public health promotion given the history of unequal application of punitive consequences of drug use for racialized minorities in the United States. As products, delivery systems, potency, and marketing proliferate within a for-profit industry, increased attention to youth trends, including investment in sustained and evidence-based prevention and intervention, is increasingly necessary.”
The take-home message for clinicians is to ask whether your patients are vaping, because the prevalence is not only up, but fairly universal, Mx. Kreski said. “Have a discussion that covers a broad range of substance use topics and informs teens of the potential risks of vaping, while avoiding stigma.”
The message for parents is “to talk to your kids about the risks of vaping,” said Mx. Kreski. “Prioritize open communication rather than punishment, and work together with your teens to prevent or reduce vaping.” The message for teens: “Understand that vaping has risks. You should feel empowered to talk to your parents or doctor about those risks. While it may seem like everyone’s vaping, the majority don’t. Keeping communication open between parents/caregivers, teens, and health care providers is one of the best ways to address these trends in vaping.”
Beware more powerful cannabis products
“While drug use in general is declining in adolescents, marijuana use remains very common,” Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview.
“There is growing evidence that marijuana is now the first drug used by adolescents – replacing alcohol and nicotine – and frequent use can lead to substance abuse,” said Dr. Curran, who specializes in adolescent medicine but was involved in the study. “Cannabis use patterns have evolved over time. As I frequently tell my patients and their families, new strains and hybrids of marijuana have higher potencies of THC. Many adolescents are eschewing smoking and in its place using marijuana concentrates (wax, oil, shatter) via vape, dab pen, or rig. Use of these methods puts adolescents at high risk of social and health complications such as [e-cigarette or vaping use-associated lung injury], cannabis hyperemesis syndrome, and psychosis – and understanding these patterns and associated drug use helps health care professionals and parents keep adolescents safe.”
The take-home message for clinicians is that marijuana use via vaping continues to rise and to become more common than “traditional” marijuana smoking, Dr. Curran said. “This increase is across genders, in nearly all race/ethnicities (especially in Latinx youth), and in youth from lower socioeconomic status.” Vaping marijuana is associated with other substance abuse, so health care professionals should include questions about different forms of marijuana use, such as vape, dab pen, or rig, when working with patients, and counsel patients and families about the risks associated with use of any of these products.
The study was supported by the National Center for Injury Prevention and Control and by the National Institute on Drug Abuse. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
More teenagers in the United States reported cannabis use with vaping in 2019, compared with 2017, while cannabis use without vaping declined, based on annual survey data from more than 50,000 teens.
“With vaping prevalence rising so quickly among teens, getting a clearer picture of how cannabis use is shifting helps inform prevention and cessation efforts,” corresponding author Noah T. Kreski, MPH, of Columbia University, New York, said in an interview.
“In just 2 years, the most common cannabis use pattern changed from ‘occasional use without vaping’ to ‘frequent use with vaping,’ said Mx. Kreski, who uses the honorific Mx. and the pronouns they/them. “Knowing that, as well as the high overlap of cannabis vaping with nicotine use and binge drinking, adds to the urgency of reducing adolescent vaping.”
To quantify the trends in cannabis vaping, the researchers reviewed data from Monitoring the Future, an annual survey of high school students across the United States. The study population included 51,052 individuals; approximately 49% were male and 49% were non-Hispanic White. The researchers examined frequency of cannabis use, trends across demographic groups, and concurrent use of cannabis and other substances such as alcohol and tobacco. The findings were published in the journal Addiction.
Frequent cannabis use was defined as six or more times in the past 30 days; occasional use was defined as one to five times in the past 30 days.
Frequent cannabis use with vaping increased from 2.1% in 2017 to 5.4% in 2019. Occasional cannabis use with vaping also increased, though less dramatically, from less than 2% in 2017 to approximately 3.5% in 2019.
By contrast, both frequent and occasional cannabis use without vaping declined from 2017 to 2019 (from 3.8% to 2.1% and from 6.9% to 4.4%, respectively).
Overall, the prevalence of any level of cannabis use increased from 13.9% in 2017 to 15.4% in 2019. Both males and females showed a similar increase in reported frequent cannabis use with vaping of approximately 3%.
The results document that vaping cannabis has become more common than smoking alone among U.S. teens across almost all demographic groups, and across sex, race, urbanicity, and level of parent education; however, the increased was especially marked among Hispanic/Latinx teens and those of lower socioeconomic status, the researchers wrote.
The researchers also examined the associations between cannabis use with and without vaping and concurrent nicotine and alcohol use. Overall, the strongest association was between smoking or vaping nicotine and vaping cannabis; teens who smoked or vaped nicotine were 42 times more likely than nonnicotine users to report vaping cannabis in the past 30 days (adjusted odds ratio, 42.28). In addition, more occasions of binge drinking were more strongly associated with cannabis use with vaping (up to 10 times more likely), compared with cannabis use without vaping, (aORs, 4.48-10.09).
The study findings were limited by several factors, including the lack of questions on tetrahydrocannabinol (THC) or cannabidiol content of the cannabis products used, although evidence suggests that the potency of cannabis products in the United States is increasing, the researchers noted. Other limitations included the cross-sectional design, which prevents making associations about causality, and lack of data on the quantity of cannabis used; only data on frequency of use were recorded.
However, the results reflect a rise in cannabis use with vaping among teens in the United States, along with an increased risk of tobacco use, e-cigarette use, and binge drinking, the researchers said.
As cannabis legalization expands across the United States, policies are needed to deter use among adolescents, the researchers wrote. “These policies should be crafted to reduce an emphasis on criminalization in preference for public health promotion given the history of unequal application of punitive consequences of drug use for racialized minorities in the United States. As products, delivery systems, potency, and marketing proliferate within a for-profit industry, increased attention to youth trends, including investment in sustained and evidence-based prevention and intervention, is increasingly necessary.”
The take-home message for clinicians is to ask whether your patients are vaping, because the prevalence is not only up, but fairly universal, Mx. Kreski said. “Have a discussion that covers a broad range of substance use topics and informs teens of the potential risks of vaping, while avoiding stigma.”
The message for parents is “to talk to your kids about the risks of vaping,” said Mx. Kreski. “Prioritize open communication rather than punishment, and work together with your teens to prevent or reduce vaping.” The message for teens: “Understand that vaping has risks. You should feel empowered to talk to your parents or doctor about those risks. While it may seem like everyone’s vaping, the majority don’t. Keeping communication open between parents/caregivers, teens, and health care providers is one of the best ways to address these trends in vaping.”
Beware more powerful cannabis products
“While drug use in general is declining in adolescents, marijuana use remains very common,” Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview.
“There is growing evidence that marijuana is now the first drug used by adolescents – replacing alcohol and nicotine – and frequent use can lead to substance abuse,” said Dr. Curran, who specializes in adolescent medicine but was involved in the study. “Cannabis use patterns have evolved over time. As I frequently tell my patients and their families, new strains and hybrids of marijuana have higher potencies of THC. Many adolescents are eschewing smoking and in its place using marijuana concentrates (wax, oil, shatter) via vape, dab pen, or rig. Use of these methods puts adolescents at high risk of social and health complications such as [e-cigarette or vaping use-associated lung injury], cannabis hyperemesis syndrome, and psychosis – and understanding these patterns and associated drug use helps health care professionals and parents keep adolescents safe.”
The take-home message for clinicians is that marijuana use via vaping continues to rise and to become more common than “traditional” marijuana smoking, Dr. Curran said. “This increase is across genders, in nearly all race/ethnicities (especially in Latinx youth), and in youth from lower socioeconomic status.” Vaping marijuana is associated with other substance abuse, so health care professionals should include questions about different forms of marijuana use, such as vape, dab pen, or rig, when working with patients, and counsel patients and families about the risks associated with use of any of these products.
The study was supported by the National Center for Injury Prevention and Control and by the National Institute on Drug Abuse. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
More teenagers in the United States reported cannabis use with vaping in 2019, compared with 2017, while cannabis use without vaping declined, based on annual survey data from more than 50,000 teens.
“With vaping prevalence rising so quickly among teens, getting a clearer picture of how cannabis use is shifting helps inform prevention and cessation efforts,” corresponding author Noah T. Kreski, MPH, of Columbia University, New York, said in an interview.
“In just 2 years, the most common cannabis use pattern changed from ‘occasional use without vaping’ to ‘frequent use with vaping,’ said Mx. Kreski, who uses the honorific Mx. and the pronouns they/them. “Knowing that, as well as the high overlap of cannabis vaping with nicotine use and binge drinking, adds to the urgency of reducing adolescent vaping.”
To quantify the trends in cannabis vaping, the researchers reviewed data from Monitoring the Future, an annual survey of high school students across the United States. The study population included 51,052 individuals; approximately 49% were male and 49% were non-Hispanic White. The researchers examined frequency of cannabis use, trends across demographic groups, and concurrent use of cannabis and other substances such as alcohol and tobacco. The findings were published in the journal Addiction.
Frequent cannabis use was defined as six or more times in the past 30 days; occasional use was defined as one to five times in the past 30 days.
Frequent cannabis use with vaping increased from 2.1% in 2017 to 5.4% in 2019. Occasional cannabis use with vaping also increased, though less dramatically, from less than 2% in 2017 to approximately 3.5% in 2019.
By contrast, both frequent and occasional cannabis use without vaping declined from 2017 to 2019 (from 3.8% to 2.1% and from 6.9% to 4.4%, respectively).
Overall, the prevalence of any level of cannabis use increased from 13.9% in 2017 to 15.4% in 2019. Both males and females showed a similar increase in reported frequent cannabis use with vaping of approximately 3%.
The results document that vaping cannabis has become more common than smoking alone among U.S. teens across almost all demographic groups, and across sex, race, urbanicity, and level of parent education; however, the increased was especially marked among Hispanic/Latinx teens and those of lower socioeconomic status, the researchers wrote.
The researchers also examined the associations between cannabis use with and without vaping and concurrent nicotine and alcohol use. Overall, the strongest association was between smoking or vaping nicotine and vaping cannabis; teens who smoked or vaped nicotine were 42 times more likely than nonnicotine users to report vaping cannabis in the past 30 days (adjusted odds ratio, 42.28). In addition, more occasions of binge drinking were more strongly associated with cannabis use with vaping (up to 10 times more likely), compared with cannabis use without vaping, (aORs, 4.48-10.09).
The study findings were limited by several factors, including the lack of questions on tetrahydrocannabinol (THC) or cannabidiol content of the cannabis products used, although evidence suggests that the potency of cannabis products in the United States is increasing, the researchers noted. Other limitations included the cross-sectional design, which prevents making associations about causality, and lack of data on the quantity of cannabis used; only data on frequency of use were recorded.
However, the results reflect a rise in cannabis use with vaping among teens in the United States, along with an increased risk of tobacco use, e-cigarette use, and binge drinking, the researchers said.
As cannabis legalization expands across the United States, policies are needed to deter use among adolescents, the researchers wrote. “These policies should be crafted to reduce an emphasis on criminalization in preference for public health promotion given the history of unequal application of punitive consequences of drug use for racialized minorities in the United States. As products, delivery systems, potency, and marketing proliferate within a for-profit industry, increased attention to youth trends, including investment in sustained and evidence-based prevention and intervention, is increasingly necessary.”
The take-home message for clinicians is to ask whether your patients are vaping, because the prevalence is not only up, but fairly universal, Mx. Kreski said. “Have a discussion that covers a broad range of substance use topics and informs teens of the potential risks of vaping, while avoiding stigma.”
The message for parents is “to talk to your kids about the risks of vaping,” said Mx. Kreski. “Prioritize open communication rather than punishment, and work together with your teens to prevent or reduce vaping.” The message for teens: “Understand that vaping has risks. You should feel empowered to talk to your parents or doctor about those risks. While it may seem like everyone’s vaping, the majority don’t. Keeping communication open between parents/caregivers, teens, and health care providers is one of the best ways to address these trends in vaping.”
Beware more powerful cannabis products
“While drug use in general is declining in adolescents, marijuana use remains very common,” Kelly A. Curran, MD, of the University of Oklahoma Health Sciences Center, Oklahoma City, said in an interview.
“There is growing evidence that marijuana is now the first drug used by adolescents – replacing alcohol and nicotine – and frequent use can lead to substance abuse,” said Dr. Curran, who specializes in adolescent medicine but was involved in the study. “Cannabis use patterns have evolved over time. As I frequently tell my patients and their families, new strains and hybrids of marijuana have higher potencies of THC. Many adolescents are eschewing smoking and in its place using marijuana concentrates (wax, oil, shatter) via vape, dab pen, or rig. Use of these methods puts adolescents at high risk of social and health complications such as [e-cigarette or vaping use-associated lung injury], cannabis hyperemesis syndrome, and psychosis – and understanding these patterns and associated drug use helps health care professionals and parents keep adolescents safe.”
The take-home message for clinicians is that marijuana use via vaping continues to rise and to become more common than “traditional” marijuana smoking, Dr. Curran said. “This increase is across genders, in nearly all race/ethnicities (especially in Latinx youth), and in youth from lower socioeconomic status.” Vaping marijuana is associated with other substance abuse, so health care professionals should include questions about different forms of marijuana use, such as vape, dab pen, or rig, when working with patients, and counsel patients and families about the risks associated with use of any of these products.
The study was supported by the National Center for Injury Prevention and Control and by the National Institute on Drug Abuse. The researchers had no financial conflicts to disclose. Dr. Curran had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
FROM ADDICTION
Ondansetron use for acute gastroenteritis in children accelerates
Use of oral ondansetron for acute gastroenteritis in children in an emergency setting increased significantly between 2006 and 2018, but use of intravenous fluids remained consistent, based on data from a cross-sectional analysis.
Recommendations for managing acute gastroenteritis in children include oral rehydration therapy for mild to moderate cases and intravenous rehydration for severe cases, Brett Burstein, MDCM, of McGill University, Montreal, and colleagues wrote.
Oral ondansetron has been shown to reduce vomiting and the need for intravenous rehydration, as well as reduce the need for hospitalization in children with evidence of dehydration, but has no significant benefits for children who are not dehydrated, the researchers noted.
“Given the high prevalence and costs associated with acute gastroenteritis treatment for children, understanding national trends in management in a broad, generalizable sample is important,” they wrote.
In a study published in JAMA Network Open, the researchers identified data from the National Hospital Ambulatory Medical Care Survey from Jan. 1, 2006, to Dec. 31, 2018. They analyzed ED visits by individuals younger than 18 years with either a primary discharge diagnosis of acute gastroenteritis or a primary diagnosis of nausea, vomiting, diarrhea, or dehydration with a secondary diagnosis of acute gastroenteritis. The study population included 4,122 patients with a mean age of 4.8 years. Approximately 85% of the visits were to nonacademic EDs, and 80% were to nonpediatric EDs.
Overall, ED visits for acute gastroenteritis increased over time, from 1.23 million in 2006 to 1.87 million in 2018 (P = .03 for trend). ED visits for acute gastroenteritis also increased significantly as a proportion of all ED pediatric visits, from 4.7% in 2006 to 5.6% in 2018 (P = .02 for trend).
Notably, the use of ondansetron increased from 10.6% in 2006 to 59.2% in 2018; however, intravenous rehydration and hospitalizations remained consistent over the study period, the researchers wrote. Approximately half of children who received intravenous fluids (53.9%) and those hospitalized (49.1%) also received ondansetron.
“Approximately half of children administered intravenous fluids or hospitalized did not receive ondansetron, suggesting that many children without dehydration receive ondansetron with limited benefit, whereas those most likely to benefit receive intravenous fluids without an adequate trial of ondansetron and oral rehydration therapy,” the researchers wrote in their discussion of the findings.
The study findings were limited by several factors including the lack of data on detailed patient-level information such as severity of dehydration, the researchers noted. Other limitations include lack of data on return visits and lack of data on the route of medication administration, which means that the perceived lack of benefit from ondansetron may be the result of children treated with both intravenous ondansetron and fluids, they said.
“Ondansetron-supported oral rehydration therapy for appropriately selected children can achieve intravenous rehydration rates of 9%, more than threefold lower than 2018 national estimates,” and more initiatives are needed to optimize ondansetron and reduce the excessive use of intravenous fluids, the researchers concluded.
Emergency care setting may promote IV fluid use
“Acute gastroenteritis has remained a major cause of pediatric morbidity and mortality worldwide with significant costs for the health care system,” Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice who was not involved in the current study, said in an interview. “The authors highlight that although ondansetron use for acute gastroenteritis in the ED has increased substantially, there are still a number of children who receive intravenous fluids in the ED without a trial of ondansetron and [oral rehydration therapy] first. For the individual patient, it is not surprising that the fast-paced culture of the ED doesn’t cater to a watchful waiting approach. This highlights the need for a more protocol-based algorithm for care of these patients upon check-in.
“Often the practice in the ED is a single dose of ondansetron, followed by attempts at oral rehydration 30 minutes later,” said Dr. Joos. “It would be interesting to know the extent that outpatient clinics are practicing this model prior to sending the patient on to the ED. Despite it becoming a common practice, there is still ongoing research into the efficacy and safety of multidose oral ondansetron at home in reducing ED visits/hospitalizations.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose. Lead author Dr. Burstein received a career award from the Quebec Health Research Fund.
Use of oral ondansetron for acute gastroenteritis in children in an emergency setting increased significantly between 2006 and 2018, but use of intravenous fluids remained consistent, based on data from a cross-sectional analysis.
Recommendations for managing acute gastroenteritis in children include oral rehydration therapy for mild to moderate cases and intravenous rehydration for severe cases, Brett Burstein, MDCM, of McGill University, Montreal, and colleagues wrote.
Oral ondansetron has been shown to reduce vomiting and the need for intravenous rehydration, as well as reduce the need for hospitalization in children with evidence of dehydration, but has no significant benefits for children who are not dehydrated, the researchers noted.
“Given the high prevalence and costs associated with acute gastroenteritis treatment for children, understanding national trends in management in a broad, generalizable sample is important,” they wrote.
In a study published in JAMA Network Open, the researchers identified data from the National Hospital Ambulatory Medical Care Survey from Jan. 1, 2006, to Dec. 31, 2018. They analyzed ED visits by individuals younger than 18 years with either a primary discharge diagnosis of acute gastroenteritis or a primary diagnosis of nausea, vomiting, diarrhea, or dehydration with a secondary diagnosis of acute gastroenteritis. The study population included 4,122 patients with a mean age of 4.8 years. Approximately 85% of the visits were to nonacademic EDs, and 80% were to nonpediatric EDs.
Overall, ED visits for acute gastroenteritis increased over time, from 1.23 million in 2006 to 1.87 million in 2018 (P = .03 for trend). ED visits for acute gastroenteritis also increased significantly as a proportion of all ED pediatric visits, from 4.7% in 2006 to 5.6% in 2018 (P = .02 for trend).
Notably, the use of ondansetron increased from 10.6% in 2006 to 59.2% in 2018; however, intravenous rehydration and hospitalizations remained consistent over the study period, the researchers wrote. Approximately half of children who received intravenous fluids (53.9%) and those hospitalized (49.1%) also received ondansetron.
“Approximately half of children administered intravenous fluids or hospitalized did not receive ondansetron, suggesting that many children without dehydration receive ondansetron with limited benefit, whereas those most likely to benefit receive intravenous fluids without an adequate trial of ondansetron and oral rehydration therapy,” the researchers wrote in their discussion of the findings.
The study findings were limited by several factors including the lack of data on detailed patient-level information such as severity of dehydration, the researchers noted. Other limitations include lack of data on return visits and lack of data on the route of medication administration, which means that the perceived lack of benefit from ondansetron may be the result of children treated with both intravenous ondansetron and fluids, they said.
“Ondansetron-supported oral rehydration therapy for appropriately selected children can achieve intravenous rehydration rates of 9%, more than threefold lower than 2018 national estimates,” and more initiatives are needed to optimize ondansetron and reduce the excessive use of intravenous fluids, the researchers concluded.
Emergency care setting may promote IV fluid use
“Acute gastroenteritis has remained a major cause of pediatric morbidity and mortality worldwide with significant costs for the health care system,” Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice who was not involved in the current study, said in an interview. “The authors highlight that although ondansetron use for acute gastroenteritis in the ED has increased substantially, there are still a number of children who receive intravenous fluids in the ED without a trial of ondansetron and [oral rehydration therapy] first. For the individual patient, it is not surprising that the fast-paced culture of the ED doesn’t cater to a watchful waiting approach. This highlights the need for a more protocol-based algorithm for care of these patients upon check-in.
“Often the practice in the ED is a single dose of ondansetron, followed by attempts at oral rehydration 30 minutes later,” said Dr. Joos. “It would be interesting to know the extent that outpatient clinics are practicing this model prior to sending the patient on to the ED. Despite it becoming a common practice, there is still ongoing research into the efficacy and safety of multidose oral ondansetron at home in reducing ED visits/hospitalizations.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose. Lead author Dr. Burstein received a career award from the Quebec Health Research Fund.
Use of oral ondansetron for acute gastroenteritis in children in an emergency setting increased significantly between 2006 and 2018, but use of intravenous fluids remained consistent, based on data from a cross-sectional analysis.
Recommendations for managing acute gastroenteritis in children include oral rehydration therapy for mild to moderate cases and intravenous rehydration for severe cases, Brett Burstein, MDCM, of McGill University, Montreal, and colleagues wrote.
Oral ondansetron has been shown to reduce vomiting and the need for intravenous rehydration, as well as reduce the need for hospitalization in children with evidence of dehydration, but has no significant benefits for children who are not dehydrated, the researchers noted.
“Given the high prevalence and costs associated with acute gastroenteritis treatment for children, understanding national trends in management in a broad, generalizable sample is important,” they wrote.
In a study published in JAMA Network Open, the researchers identified data from the National Hospital Ambulatory Medical Care Survey from Jan. 1, 2006, to Dec. 31, 2018. They analyzed ED visits by individuals younger than 18 years with either a primary discharge diagnosis of acute gastroenteritis or a primary diagnosis of nausea, vomiting, diarrhea, or dehydration with a secondary diagnosis of acute gastroenteritis. The study population included 4,122 patients with a mean age of 4.8 years. Approximately 85% of the visits were to nonacademic EDs, and 80% were to nonpediatric EDs.
Overall, ED visits for acute gastroenteritis increased over time, from 1.23 million in 2006 to 1.87 million in 2018 (P = .03 for trend). ED visits for acute gastroenteritis also increased significantly as a proportion of all ED pediatric visits, from 4.7% in 2006 to 5.6% in 2018 (P = .02 for trend).
Notably, the use of ondansetron increased from 10.6% in 2006 to 59.2% in 2018; however, intravenous rehydration and hospitalizations remained consistent over the study period, the researchers wrote. Approximately half of children who received intravenous fluids (53.9%) and those hospitalized (49.1%) also received ondansetron.
“Approximately half of children administered intravenous fluids or hospitalized did not receive ondansetron, suggesting that many children without dehydration receive ondansetron with limited benefit, whereas those most likely to benefit receive intravenous fluids without an adequate trial of ondansetron and oral rehydration therapy,” the researchers wrote in their discussion of the findings.
The study findings were limited by several factors including the lack of data on detailed patient-level information such as severity of dehydration, the researchers noted. Other limitations include lack of data on return visits and lack of data on the route of medication administration, which means that the perceived lack of benefit from ondansetron may be the result of children treated with both intravenous ondansetron and fluids, they said.
“Ondansetron-supported oral rehydration therapy for appropriately selected children can achieve intravenous rehydration rates of 9%, more than threefold lower than 2018 national estimates,” and more initiatives are needed to optimize ondansetron and reduce the excessive use of intravenous fluids, the researchers concluded.
Emergency care setting may promote IV fluid use
“Acute gastroenteritis has remained a major cause of pediatric morbidity and mortality worldwide with significant costs for the health care system,” Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice who was not involved in the current study, said in an interview. “The authors highlight that although ondansetron use for acute gastroenteritis in the ED has increased substantially, there are still a number of children who receive intravenous fluids in the ED without a trial of ondansetron and [oral rehydration therapy] first. For the individual patient, it is not surprising that the fast-paced culture of the ED doesn’t cater to a watchful waiting approach. This highlights the need for a more protocol-based algorithm for care of these patients upon check-in.
“Often the practice in the ED is a single dose of ondansetron, followed by attempts at oral rehydration 30 minutes later,” said Dr. Joos. “It would be interesting to know the extent that outpatient clinics are practicing this model prior to sending the patient on to the ED. Despite it becoming a common practice, there is still ongoing research into the efficacy and safety of multidose oral ondansetron at home in reducing ED visits/hospitalizations.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose. Lead author Dr. Burstein received a career award from the Quebec Health Research Fund.
FROM JAMA NETWORK OPEN
Severe infections often accompany severe psoriasis
of nearly 95,000 patients.
Although previous studies have shown a higher risk for comorbid conditions in people with psoriasis, compared with those without psoriasis, data on the occurrence of severe and rare infections in patients with psoriasis are limited, wrote Nikolai Loft, MD, of the department of dermatology and allergy, Copenhagen University Hospital, Gentofte, and colleagues.
Psoriasis patients are often treated with immunosuppressive therapies that may promote or aggravate infections; therefore, a better understanding of psoriasis and risk of infections is needed, they said. In a study published in the British Journal of Dermatology, Dr. Loft and his coinvestigators reviewed data on adults aged 18 years and older from the Danish National Patient Register between Jan. 1, 1997 and Dec. 31, 2018. The study population included 94,450 adults with psoriasis and 566,700 matched controls. Patients with any type of psoriasis and any degree of severity were included.
The primary outcome was the occurrence of severe infections, defined as those requiring assessment at a hospital, and rare infections, defined as HIV, TB, HBV, and HCV. The median age of the participants was 52.3 years, and slightly more than half were women.
Overall, the incidence rate of severe and rare infections among patients with any type of psoriasis was 3,104.9 per 100,000 person-years, compared with 2,381.1 for controls, with a hazard ratio, adjusted for gender, age, ethnicity, socioeconomic status, alcohol-related conditions, and Charlson comorbidity index (aHR) of 1.29.
For any infections resulting in hospitalization, the incidence rate was 2,005.1 vs. 1,531.8 per 100,000 person-years for patients with any type of psoriasis and controls, respectively.
The results were similar when severe infections and rare infections were analyzed separately. The incidence rate of severe infections was 3,080.6 and 2,364.4 per 100,000 person-years for patients with any psoriasis, compared with controls; the incidence rate for rare infections was 42.9 and 31.8 for all psoriasis patients and controls, respectively.
When the data were examined by psoriasis severity, the incidence rate of severe and rare infections among patients with severe psoriasis was 3,847.7 per 100,000 person-years, compared with 2,351.9 per 100,000 person years among controls (aHR, 1.58) and also higher than in patients with mild psoriasis. The incidence rate of severe and rare infections in patients with mild psoriasis (2,979.1 per 100,000 person-years) also was higher than in controls (aHR, 1.26).
Factors that might explain the increased infection risk with severe psoriasis include the altered immune environment in these patients, the researchers wrote in their discussion of the findings. Also, “patients with severe psoriasis are defined by their eligibility for systemics, either conventional or biologic,” and their increased infection risk may stem from these treatments, rather than disease severity itself, they noted.
The study findings were limited by several factors including the lack of data on such confounders as weight, body mass index, and smoking status, they added. Other limitations included potential surveillance bias because of greater TB screening, and the use of prescriptions, rather than the Psoriasis Area Severity Index, to define severity. However, the results were strengthened by the large sample size, and suggest that patients with any type of psoriasis have higher rates of any infection, severe or rare, than the general population, the researchers concluded.
Data show need for clinician vigilance
Based on the 2020 Census data, an estimated 7.55 million adults in the United States have psoriasis, David Robles, MD, said in an interview. “Patients with psoriasis have a high risk for multiple comorbid conditions including metabolic syndrome, which is characterized by obesity, hypertension, and dyslipidemia,” said Dr. Robles, a dermatologist in private practice in Pomona, Calif., who was not involved in the study. “Although these complications were previously attributed to diet and obesity, it has become clear that the proinflammatory cytokines associated with psoriasis may be playing an important role underlying the pathologic basis of these other comorbidities.”
There is an emerging body of literature “indicating that psoriasis is associated with an increased risk of infections,” he added. Research in this area is particularly important because of the increased risk of infections associated with many biologic and immune-modulating treatments for psoriasis, Dr. Robles noted.
The study findings “indicate that, as the severity of psoriasis increases, so does the risk of severe and rare infections,” he said. “This makes it imperative for clinicians to be alert to the possibility of severe or rare infections in patients with psoriasis, especially those with severe psoriasis, so that early intervention can be initiated.”
As for additional research, “as an immunologist and dermatologist, I cannot help but think about the possible role the genetic and cytokine pathways involved in psoriasis may be playing in modulating the immune system and/or microbiome, and whether this contributes to a higher risk of infections,” Dr. Robles said. “Just as it was discovered that patients with atopic dermatitis have decreased levels of antimicrobial peptides in their skin, making them susceptible to recurrent bacterial skin infections, we may find that the genetic and immunological changes associated with psoriasis may independently contribute to infection susceptibility,” he noted. “More basic immunology and virology research may one day shed light on this observation.”
The study was supported by Novartis. Lead author Dr. Loft disclosed serving as a speaker for Eli Lilly and Janssen Cilag, other authors disclosed relationships with multiple companies including Novartis, and two authors are Novartis employees. Dr. Robles had no relevant financial disclosures.
of nearly 95,000 patients.
Although previous studies have shown a higher risk for comorbid conditions in people with psoriasis, compared with those without psoriasis, data on the occurrence of severe and rare infections in patients with psoriasis are limited, wrote Nikolai Loft, MD, of the department of dermatology and allergy, Copenhagen University Hospital, Gentofte, and colleagues.
Psoriasis patients are often treated with immunosuppressive therapies that may promote or aggravate infections; therefore, a better understanding of psoriasis and risk of infections is needed, they said. In a study published in the British Journal of Dermatology, Dr. Loft and his coinvestigators reviewed data on adults aged 18 years and older from the Danish National Patient Register between Jan. 1, 1997 and Dec. 31, 2018. The study population included 94,450 adults with psoriasis and 566,700 matched controls. Patients with any type of psoriasis and any degree of severity were included.
The primary outcome was the occurrence of severe infections, defined as those requiring assessment at a hospital, and rare infections, defined as HIV, TB, HBV, and HCV. The median age of the participants was 52.3 years, and slightly more than half were women.
Overall, the incidence rate of severe and rare infections among patients with any type of psoriasis was 3,104.9 per 100,000 person-years, compared with 2,381.1 for controls, with a hazard ratio, adjusted for gender, age, ethnicity, socioeconomic status, alcohol-related conditions, and Charlson comorbidity index (aHR) of 1.29.
For any infections resulting in hospitalization, the incidence rate was 2,005.1 vs. 1,531.8 per 100,000 person-years for patients with any type of psoriasis and controls, respectively.
The results were similar when severe infections and rare infections were analyzed separately. The incidence rate of severe infections was 3,080.6 and 2,364.4 per 100,000 person-years for patients with any psoriasis, compared with controls; the incidence rate for rare infections was 42.9 and 31.8 for all psoriasis patients and controls, respectively.
When the data were examined by psoriasis severity, the incidence rate of severe and rare infections among patients with severe psoriasis was 3,847.7 per 100,000 person-years, compared with 2,351.9 per 100,000 person years among controls (aHR, 1.58) and also higher than in patients with mild psoriasis. The incidence rate of severe and rare infections in patients with mild psoriasis (2,979.1 per 100,000 person-years) also was higher than in controls (aHR, 1.26).
Factors that might explain the increased infection risk with severe psoriasis include the altered immune environment in these patients, the researchers wrote in their discussion of the findings. Also, “patients with severe psoriasis are defined by their eligibility for systemics, either conventional or biologic,” and their increased infection risk may stem from these treatments, rather than disease severity itself, they noted.
The study findings were limited by several factors including the lack of data on such confounders as weight, body mass index, and smoking status, they added. Other limitations included potential surveillance bias because of greater TB screening, and the use of prescriptions, rather than the Psoriasis Area Severity Index, to define severity. However, the results were strengthened by the large sample size, and suggest that patients with any type of psoriasis have higher rates of any infection, severe or rare, than the general population, the researchers concluded.
Data show need for clinician vigilance
Based on the 2020 Census data, an estimated 7.55 million adults in the United States have psoriasis, David Robles, MD, said in an interview. “Patients with psoriasis have a high risk for multiple comorbid conditions including metabolic syndrome, which is characterized by obesity, hypertension, and dyslipidemia,” said Dr. Robles, a dermatologist in private practice in Pomona, Calif., who was not involved in the study. “Although these complications were previously attributed to diet and obesity, it has become clear that the proinflammatory cytokines associated with psoriasis may be playing an important role underlying the pathologic basis of these other comorbidities.”
There is an emerging body of literature “indicating that psoriasis is associated with an increased risk of infections,” he added. Research in this area is particularly important because of the increased risk of infections associated with many biologic and immune-modulating treatments for psoriasis, Dr. Robles noted.
The study findings “indicate that, as the severity of psoriasis increases, so does the risk of severe and rare infections,” he said. “This makes it imperative for clinicians to be alert to the possibility of severe or rare infections in patients with psoriasis, especially those with severe psoriasis, so that early intervention can be initiated.”
As for additional research, “as an immunologist and dermatologist, I cannot help but think about the possible role the genetic and cytokine pathways involved in psoriasis may be playing in modulating the immune system and/or microbiome, and whether this contributes to a higher risk of infections,” Dr. Robles said. “Just as it was discovered that patients with atopic dermatitis have decreased levels of antimicrobial peptides in their skin, making them susceptible to recurrent bacterial skin infections, we may find that the genetic and immunological changes associated with psoriasis may independently contribute to infection susceptibility,” he noted. “More basic immunology and virology research may one day shed light on this observation.”
The study was supported by Novartis. Lead author Dr. Loft disclosed serving as a speaker for Eli Lilly and Janssen Cilag, other authors disclosed relationships with multiple companies including Novartis, and two authors are Novartis employees. Dr. Robles had no relevant financial disclosures.
of nearly 95,000 patients.
Although previous studies have shown a higher risk for comorbid conditions in people with psoriasis, compared with those without psoriasis, data on the occurrence of severe and rare infections in patients with psoriasis are limited, wrote Nikolai Loft, MD, of the department of dermatology and allergy, Copenhagen University Hospital, Gentofte, and colleagues.
Psoriasis patients are often treated with immunosuppressive therapies that may promote or aggravate infections; therefore, a better understanding of psoriasis and risk of infections is needed, they said. In a study published in the British Journal of Dermatology, Dr. Loft and his coinvestigators reviewed data on adults aged 18 years and older from the Danish National Patient Register between Jan. 1, 1997 and Dec. 31, 2018. The study population included 94,450 adults with psoriasis and 566,700 matched controls. Patients with any type of psoriasis and any degree of severity were included.
The primary outcome was the occurrence of severe infections, defined as those requiring assessment at a hospital, and rare infections, defined as HIV, TB, HBV, and HCV. The median age of the participants was 52.3 years, and slightly more than half were women.
Overall, the incidence rate of severe and rare infections among patients with any type of psoriasis was 3,104.9 per 100,000 person-years, compared with 2,381.1 for controls, with a hazard ratio, adjusted for gender, age, ethnicity, socioeconomic status, alcohol-related conditions, and Charlson comorbidity index (aHR) of 1.29.
For any infections resulting in hospitalization, the incidence rate was 2,005.1 vs. 1,531.8 per 100,000 person-years for patients with any type of psoriasis and controls, respectively.
The results were similar when severe infections and rare infections were analyzed separately. The incidence rate of severe infections was 3,080.6 and 2,364.4 per 100,000 person-years for patients with any psoriasis, compared with controls; the incidence rate for rare infections was 42.9 and 31.8 for all psoriasis patients and controls, respectively.
When the data were examined by psoriasis severity, the incidence rate of severe and rare infections among patients with severe psoriasis was 3,847.7 per 100,000 person-years, compared with 2,351.9 per 100,000 person years among controls (aHR, 1.58) and also higher than in patients with mild psoriasis. The incidence rate of severe and rare infections in patients with mild psoriasis (2,979.1 per 100,000 person-years) also was higher than in controls (aHR, 1.26).
Factors that might explain the increased infection risk with severe psoriasis include the altered immune environment in these patients, the researchers wrote in their discussion of the findings. Also, “patients with severe psoriasis are defined by their eligibility for systemics, either conventional or biologic,” and their increased infection risk may stem from these treatments, rather than disease severity itself, they noted.
The study findings were limited by several factors including the lack of data on such confounders as weight, body mass index, and smoking status, they added. Other limitations included potential surveillance bias because of greater TB screening, and the use of prescriptions, rather than the Psoriasis Area Severity Index, to define severity. However, the results were strengthened by the large sample size, and suggest that patients with any type of psoriasis have higher rates of any infection, severe or rare, than the general population, the researchers concluded.
Data show need for clinician vigilance
Based on the 2020 Census data, an estimated 7.55 million adults in the United States have psoriasis, David Robles, MD, said in an interview. “Patients with psoriasis have a high risk for multiple comorbid conditions including metabolic syndrome, which is characterized by obesity, hypertension, and dyslipidemia,” said Dr. Robles, a dermatologist in private practice in Pomona, Calif., who was not involved in the study. “Although these complications were previously attributed to diet and obesity, it has become clear that the proinflammatory cytokines associated with psoriasis may be playing an important role underlying the pathologic basis of these other comorbidities.”
There is an emerging body of literature “indicating that psoriasis is associated with an increased risk of infections,” he added. Research in this area is particularly important because of the increased risk of infections associated with many biologic and immune-modulating treatments for psoriasis, Dr. Robles noted.
The study findings “indicate that, as the severity of psoriasis increases, so does the risk of severe and rare infections,” he said. “This makes it imperative for clinicians to be alert to the possibility of severe or rare infections in patients with psoriasis, especially those with severe psoriasis, so that early intervention can be initiated.”
As for additional research, “as an immunologist and dermatologist, I cannot help but think about the possible role the genetic and cytokine pathways involved in psoriasis may be playing in modulating the immune system and/or microbiome, and whether this contributes to a higher risk of infections,” Dr. Robles said. “Just as it was discovered that patients with atopic dermatitis have decreased levels of antimicrobial peptides in their skin, making them susceptible to recurrent bacterial skin infections, we may find that the genetic and immunological changes associated with psoriasis may independently contribute to infection susceptibility,” he noted. “More basic immunology and virology research may one day shed light on this observation.”
The study was supported by Novartis. Lead author Dr. Loft disclosed serving as a speaker for Eli Lilly and Janssen Cilag, other authors disclosed relationships with multiple companies including Novartis, and two authors are Novartis employees. Dr. Robles had no relevant financial disclosures.
FROM BRITISH JOURNAL OF DERMATOLOGY
Most COVID-19 survivors return to work within 2 years
The burden of persistent COVID-19 symptoms appeared to improve over time, but a higher percentage of former patients reported poor health, compared with the general population. This suggests that some patients need more time to completely recover from COVID-19, wrote the authors of the new study, which was published in The Lancet Respiratory Medicine. Previous research has shown that the health effects of COVID-19 last for up to a year, but data from longer-term studies are limited, said Lixue Huang, MD, of Capital Medical University, Beijing, one of the study authors, and colleagues.
Methods and results
In the new study, the researchers reviewed data from 1,192 adult patients who were discharged from the hospital after surviving COVID-19 between Jan. 7, 2020, and May 29, 2020. The researchers measured the participants’ health outcomes at 6 months, 12 months, and 2 years after their onset of symptoms. A community-based dataset of 3,383 adults with no history of COVID-19 served as controls to measure the recovery of the COVID-19 patients. The median age of the patients at the time of hospital discharge was 57 years, and 46% were women. The median follow-up time after the onset of symptoms was 185 days, 349 days, and 685 days for the 6-month, 12-month, and 2-year visits, respectively. The researchers measured health outcomes using a 6-min walking distance (6MWD) test, laboratory tests, and questionnaires about symptoms, mental health, health-related quality of life, returning to work, and health care use since leaving the hospital.
Overall, the proportion of COVID-19 survivors with at least one symptom decreased from 68% at 6 months to 55% at 2 years (P < .0001). The most frequent symptoms were fatigue and muscle weakness, reported by approximately one-third of the patients (31%); sleep problems also were reported by 31% of the patients.
The proportion of individuals with poor results on the 6MWD decreased continuously over time, not only in COVID-19 survivors overall, but also in three subgroups of varying initial disease severity. Of the 494 survivors who reported working before becoming ill, 438 (89%) had returned to their original jobs 2 years later. The most common reasons for not returning to work were decreased physical function, unwillingness to return, and unemployment, the researchers noted.
However, at 2 years, COVID-19 survivors reported more pain and discomfort, as well as more anxiety and depression, compared with the controls (23% vs. 5% and 12% vs. 5%, respectively).
In addition, significantly more survivors who needed high levels of respiratory support while hospitalized had lung diffusion impairment (65%), reduced residual volume (62%), and total lung capacity (39%), compared with matched controls (36%, 20%, and 6%, respectively) at 2 years.
Long-COVID concerns
Approximately half of the survivors had symptoms of long COVID at 2 years. These individuals were more likely to report pain or discomfort or anxiety or depression, as well as mobility problems, compared to survivors without long COVID. Participants with long-COVID symptoms were more than twice as likely to have an outpatient clinic visit (odds ratio, 2.82), and not quite twice as likely to be rehospitalized (OR, 1.64).
“We found that [health-related quality of life], exercise capacity, and mental health continued to improve throughout the 2 years regardless of initial disease severity, but about half still had symptomatic sequelae at 2 years,” the researchers wrote in their paper.
Findings can inform doctor-patient discussions
“We are increasingly recognizing that the health effects of COVID-19 may persist beyond acute illness, therefore this is a timely study to assess the long-term impact of COVID-19 with a long follow-up period,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.
The findings are consistent with the existing literature, said Dr. Pal, who was not involved in the study. The data from the study “can help clinicians have discussions regarding expected recovery and long-term prognosis for patients with COVID-19,” he noted.
What patients should know is that “studies such as this can help COVID-19 survivors understand and monitor persistent symptoms they may experience, and bring them to the attention of their clinicians,” said Dr. Pal.
However, “As a single-center study with high attrition of subjects during the study period, the findings may not be generalizable,” Dr. Pal emphasized. “Larger-scale studies and patient registries distributed over different geographical areas and time periods will help obtain a better understanding of the nature and prevalence of long COVID,” he said.
The study findings were limited by several factors, including the lack of formerly hospitalized controls with respiratory infections other than COVID-19 to determine which outcomes are COVID-19 specific, the researchers noted. Other limitations included the use of data from only patients at a single center, and from the early stages of the pandemic, as well as the use of self-reports for comorbidities and health outcomes, they said.
However, the results represent the longest-known published longitudinal follow-up of patients who recovered from acute COVID-19, the researchers emphasized. Study strengths included the large sample size, longitudinal design, and long-term follow-up with non-COVID controls to determine outcomes. The researchers noted their plans to conduct annual follow-ups in the current study population. They added that more research is needed to explore rehabilitation programs to promote recovery for COVID-19 survivors and to reduce the effects of long COVID.
The study was supported by the Chinese Academy of Medical Sciences, National Natural Science Foundation of China, National Key Research and Development Program of China, National Administration of Traditional Chinese Medicine, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, China Evergrande Group, Jack Ma Foundation, Sino Biopharmaceutical, Ping An Insurance (Group), and New Sunshine Charity Foundation. The researchers and Dr. Pal had no financial conflicts to disclose.
This article was updated on 5/16/2022.
The burden of persistent COVID-19 symptoms appeared to improve over time, but a higher percentage of former patients reported poor health, compared with the general population. This suggests that some patients need more time to completely recover from COVID-19, wrote the authors of the new study, which was published in The Lancet Respiratory Medicine. Previous research has shown that the health effects of COVID-19 last for up to a year, but data from longer-term studies are limited, said Lixue Huang, MD, of Capital Medical University, Beijing, one of the study authors, and colleagues.
Methods and results
In the new study, the researchers reviewed data from 1,192 adult patients who were discharged from the hospital after surviving COVID-19 between Jan. 7, 2020, and May 29, 2020. The researchers measured the participants’ health outcomes at 6 months, 12 months, and 2 years after their onset of symptoms. A community-based dataset of 3,383 adults with no history of COVID-19 served as controls to measure the recovery of the COVID-19 patients. The median age of the patients at the time of hospital discharge was 57 years, and 46% were women. The median follow-up time after the onset of symptoms was 185 days, 349 days, and 685 days for the 6-month, 12-month, and 2-year visits, respectively. The researchers measured health outcomes using a 6-min walking distance (6MWD) test, laboratory tests, and questionnaires about symptoms, mental health, health-related quality of life, returning to work, and health care use since leaving the hospital.
Overall, the proportion of COVID-19 survivors with at least one symptom decreased from 68% at 6 months to 55% at 2 years (P < .0001). The most frequent symptoms were fatigue and muscle weakness, reported by approximately one-third of the patients (31%); sleep problems also were reported by 31% of the patients.
The proportion of individuals with poor results on the 6MWD decreased continuously over time, not only in COVID-19 survivors overall, but also in three subgroups of varying initial disease severity. Of the 494 survivors who reported working before becoming ill, 438 (89%) had returned to their original jobs 2 years later. The most common reasons for not returning to work were decreased physical function, unwillingness to return, and unemployment, the researchers noted.
However, at 2 years, COVID-19 survivors reported more pain and discomfort, as well as more anxiety and depression, compared with the controls (23% vs. 5% and 12% vs. 5%, respectively).
In addition, significantly more survivors who needed high levels of respiratory support while hospitalized had lung diffusion impairment (65%), reduced residual volume (62%), and total lung capacity (39%), compared with matched controls (36%, 20%, and 6%, respectively) at 2 years.
Long-COVID concerns
Approximately half of the survivors had symptoms of long COVID at 2 years. These individuals were more likely to report pain or discomfort or anxiety or depression, as well as mobility problems, compared to survivors without long COVID. Participants with long-COVID symptoms were more than twice as likely to have an outpatient clinic visit (odds ratio, 2.82), and not quite twice as likely to be rehospitalized (OR, 1.64).
“We found that [health-related quality of life], exercise capacity, and mental health continued to improve throughout the 2 years regardless of initial disease severity, but about half still had symptomatic sequelae at 2 years,” the researchers wrote in their paper.
Findings can inform doctor-patient discussions
“We are increasingly recognizing that the health effects of COVID-19 may persist beyond acute illness, therefore this is a timely study to assess the long-term impact of COVID-19 with a long follow-up period,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.
The findings are consistent with the existing literature, said Dr. Pal, who was not involved in the study. The data from the study “can help clinicians have discussions regarding expected recovery and long-term prognosis for patients with COVID-19,” he noted.
What patients should know is that “studies such as this can help COVID-19 survivors understand and monitor persistent symptoms they may experience, and bring them to the attention of their clinicians,” said Dr. Pal.
However, “As a single-center study with high attrition of subjects during the study period, the findings may not be generalizable,” Dr. Pal emphasized. “Larger-scale studies and patient registries distributed over different geographical areas and time periods will help obtain a better understanding of the nature and prevalence of long COVID,” he said.
The study findings were limited by several factors, including the lack of formerly hospitalized controls with respiratory infections other than COVID-19 to determine which outcomes are COVID-19 specific, the researchers noted. Other limitations included the use of data from only patients at a single center, and from the early stages of the pandemic, as well as the use of self-reports for comorbidities and health outcomes, they said.
However, the results represent the longest-known published longitudinal follow-up of patients who recovered from acute COVID-19, the researchers emphasized. Study strengths included the large sample size, longitudinal design, and long-term follow-up with non-COVID controls to determine outcomes. The researchers noted their plans to conduct annual follow-ups in the current study population. They added that more research is needed to explore rehabilitation programs to promote recovery for COVID-19 survivors and to reduce the effects of long COVID.
The study was supported by the Chinese Academy of Medical Sciences, National Natural Science Foundation of China, National Key Research and Development Program of China, National Administration of Traditional Chinese Medicine, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, China Evergrande Group, Jack Ma Foundation, Sino Biopharmaceutical, Ping An Insurance (Group), and New Sunshine Charity Foundation. The researchers and Dr. Pal had no financial conflicts to disclose.
This article was updated on 5/16/2022.
The burden of persistent COVID-19 symptoms appeared to improve over time, but a higher percentage of former patients reported poor health, compared with the general population. This suggests that some patients need more time to completely recover from COVID-19, wrote the authors of the new study, which was published in The Lancet Respiratory Medicine. Previous research has shown that the health effects of COVID-19 last for up to a year, but data from longer-term studies are limited, said Lixue Huang, MD, of Capital Medical University, Beijing, one of the study authors, and colleagues.
Methods and results
In the new study, the researchers reviewed data from 1,192 adult patients who were discharged from the hospital after surviving COVID-19 between Jan. 7, 2020, and May 29, 2020. The researchers measured the participants’ health outcomes at 6 months, 12 months, and 2 years after their onset of symptoms. A community-based dataset of 3,383 adults with no history of COVID-19 served as controls to measure the recovery of the COVID-19 patients. The median age of the patients at the time of hospital discharge was 57 years, and 46% were women. The median follow-up time after the onset of symptoms was 185 days, 349 days, and 685 days for the 6-month, 12-month, and 2-year visits, respectively. The researchers measured health outcomes using a 6-min walking distance (6MWD) test, laboratory tests, and questionnaires about symptoms, mental health, health-related quality of life, returning to work, and health care use since leaving the hospital.
Overall, the proportion of COVID-19 survivors with at least one symptom decreased from 68% at 6 months to 55% at 2 years (P < .0001). The most frequent symptoms were fatigue and muscle weakness, reported by approximately one-third of the patients (31%); sleep problems also were reported by 31% of the patients.
The proportion of individuals with poor results on the 6MWD decreased continuously over time, not only in COVID-19 survivors overall, but also in three subgroups of varying initial disease severity. Of the 494 survivors who reported working before becoming ill, 438 (89%) had returned to their original jobs 2 years later. The most common reasons for not returning to work were decreased physical function, unwillingness to return, and unemployment, the researchers noted.
However, at 2 years, COVID-19 survivors reported more pain and discomfort, as well as more anxiety and depression, compared with the controls (23% vs. 5% and 12% vs. 5%, respectively).
In addition, significantly more survivors who needed high levels of respiratory support while hospitalized had lung diffusion impairment (65%), reduced residual volume (62%), and total lung capacity (39%), compared with matched controls (36%, 20%, and 6%, respectively) at 2 years.
Long-COVID concerns
Approximately half of the survivors had symptoms of long COVID at 2 years. These individuals were more likely to report pain or discomfort or anxiety or depression, as well as mobility problems, compared to survivors without long COVID. Participants with long-COVID symptoms were more than twice as likely to have an outpatient clinic visit (odds ratio, 2.82), and not quite twice as likely to be rehospitalized (OR, 1.64).
“We found that [health-related quality of life], exercise capacity, and mental health continued to improve throughout the 2 years regardless of initial disease severity, but about half still had symptomatic sequelae at 2 years,” the researchers wrote in their paper.
Findings can inform doctor-patient discussions
“We are increasingly recognizing that the health effects of COVID-19 may persist beyond acute illness, therefore this is a timely study to assess the long-term impact of COVID-19 with a long follow-up period,” said Suman Pal, MD, an internal medicine physician at the University of New Mexico, Albuquerque, in an interview.
The findings are consistent with the existing literature, said Dr. Pal, who was not involved in the study. The data from the study “can help clinicians have discussions regarding expected recovery and long-term prognosis for patients with COVID-19,” he noted.
What patients should know is that “studies such as this can help COVID-19 survivors understand and monitor persistent symptoms they may experience, and bring them to the attention of their clinicians,” said Dr. Pal.
However, “As a single-center study with high attrition of subjects during the study period, the findings may not be generalizable,” Dr. Pal emphasized. “Larger-scale studies and patient registries distributed over different geographical areas and time periods will help obtain a better understanding of the nature and prevalence of long COVID,” he said.
The study findings were limited by several factors, including the lack of formerly hospitalized controls with respiratory infections other than COVID-19 to determine which outcomes are COVID-19 specific, the researchers noted. Other limitations included the use of data from only patients at a single center, and from the early stages of the pandemic, as well as the use of self-reports for comorbidities and health outcomes, they said.
However, the results represent the longest-known published longitudinal follow-up of patients who recovered from acute COVID-19, the researchers emphasized. Study strengths included the large sample size, longitudinal design, and long-term follow-up with non-COVID controls to determine outcomes. The researchers noted their plans to conduct annual follow-ups in the current study population. They added that more research is needed to explore rehabilitation programs to promote recovery for COVID-19 survivors and to reduce the effects of long COVID.
The study was supported by the Chinese Academy of Medical Sciences, National Natural Science Foundation of China, National Key Research and Development Program of China, National Administration of Traditional Chinese Medicine, Major Projects of National Science and Technology on New Drug Creation and Development of Pulmonary Tuberculosis, China Evergrande Group, Jack Ma Foundation, Sino Biopharmaceutical, Ping An Insurance (Group), and New Sunshine Charity Foundation. The researchers and Dr. Pal had no financial conflicts to disclose.
This article was updated on 5/16/2022.
FROM THE LANCET RESPIRATORY MEDICINE