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Nirsevimab protects healthy infants from RSV
A single injection of the experimental agent nirsevimab ahead of respiratory syncytial virus (RSV) season protects healthy infants from lower respiratory tract infections associated with the pathogen, according to the results of a phase 3 study.
A previously published trial showed that a single dose of nirsevimab was effective in preterm infants. The ability to protect all babies from RSV, which causes bronchiolitis and pneumonia and is a leading cause of hospitalization for this age group, “would be a paradigm shift in the approach to this disease,” William Muller, MD, PhD, of the Lurie Children’s Hospital of Chicago and a coauthor of the study, said in a statement.
The primary endpoint of the study was medically attended lower respiratory tract infections linked to RSV. The single injection of nirsevimab was associated with a 74.5% reduction in such infections (P < .001), according to Dr. Muller’s group, who published their findings March 2 in the New England Journal of Medicine.
Nirsevimab, a monoclonal antibody to the RSV fusion protein being developed by AstraZeneca and Sanofi, has an extended half-life, which may allow one dose to confer protection throughout a season. The only approved option to prevent RSV, palivizumab (Synagis), is used for high-risk infants, and five injections are needed to cover a viral season.
Nearly 1,500 infants in more than 20 countries studied
To assess the effectiveness of nirsevimab in late-preterm and term infants, investigators at 160 sites randomly assigned 1,490 babies born at a gestational age of at least 35 weeks to receive an intramuscular injection of nirsevimab or placebo.
During the 150 days after injection, medically attended RSV-associated lower respiratory tract infections occurred in 12 of 994 infants who received nirsevimab, compared with 25 of 496 babies who received placebo (1.2% vs. 5%).
Six of 994 infants who received nirsevimab were hospitalized for RSV-associated lower respiratory tract infections, compared with 8 of 496 infants in the placebo group (0.6% vs. 1.6%; P = .07). The proportion of children hospitalized for any respiratory illness as a result of RSV was 0.9% among those who received nirsevimab, compared with 2.2% among those who received placebo.
Serious adverse events occurred in 6.8% of the nirsevimab group and 7.3% of the placebo group. None of these events, including three deaths in the nirsevimab group, was considered related to nirsevimab or placebo, according to the researchers. One infant who received nirsevimab had a generalized macular rash without systemic features that did not require treatment and resolved in 20 days, they said.
Antidrug antibodies were detected in 6.1% of the nirsevimab group and in 1.1% of the placebo group. These antidrug antibodies tended to develop later and did not affect nirsevimab pharmacokinetics during the RSV season, the researchers reported. How they might affect subsequent doses of nirsevimab is not known, they added.
In a separate report in the journal, researcher Joseph Domachowske, MD, SUNY Upstate Medical University, Syracuse, New York, and colleagues described safety results from an ongoing study of nirsevimab that includes infants with congenital heart disease, chronic lung disease, and prematurity.
In this trial, infants received nirsevimab or palivizumab, and the treatments appeared to have similar safety profiles, the authors reported.
Other approaches to RSV protection include passive antibodies acquired from maternal vaccination in pregnancy and active vaccination of infants.
The publication follows news last month that GlaxoSmithKline is pausing a maternal RSV vaccine trial, which “had the same goal of protecting babies against severe RSV infection,” said Louis Bont, MD, PhD, with University Medical Center Utrecht, the Netherlands.
RSV infection is one of the deadliest diseases during infancy, and the nirsevimab trial, conducted in more than 20 countries, is “gamechanging,” Dr. Bont told this news organization. Still, researchers will need to monitor for RSV resistance to this treatment, he said.
Whether nirsevimab prevents the development of reactive airway disease and asthma is another open question, he said.
“Finally, we need to keep in mind that RSV mortality is almost limited to the developing world, and it is unlikely that this novel drug will become available to these countries in the coming years,” Dr. Bont said. “Nevertheless, nirsevimab has the potential to seriously decrease the annual overwhelming number of RSV infected babies.”
Nirsevimab may have advantages in low- and middle-income countries, including its potential to be incorporated into established immunization programs and to be given seasonally, said Amy Sarah Ginsburg, MD, MPH, of the University of Washington, Seattle. “However, cost remains a significant factor, as does susceptibility to pathogen escape,” she said.
MedImmune/AstraZeneca and Sanofi funded the nirsevimab studies. UMC Utrecht has received research grants and fees for advisory work from AstraZeneca for RSV-related work by Bont.
A version of this article first appeared on Medscape.com.
A single injection of the experimental agent nirsevimab ahead of respiratory syncytial virus (RSV) season protects healthy infants from lower respiratory tract infections associated with the pathogen, according to the results of a phase 3 study.
A previously published trial showed that a single dose of nirsevimab was effective in preterm infants. The ability to protect all babies from RSV, which causes bronchiolitis and pneumonia and is a leading cause of hospitalization for this age group, “would be a paradigm shift in the approach to this disease,” William Muller, MD, PhD, of the Lurie Children’s Hospital of Chicago and a coauthor of the study, said in a statement.
The primary endpoint of the study was medically attended lower respiratory tract infections linked to RSV. The single injection of nirsevimab was associated with a 74.5% reduction in such infections (P < .001), according to Dr. Muller’s group, who published their findings March 2 in the New England Journal of Medicine.
Nirsevimab, a monoclonal antibody to the RSV fusion protein being developed by AstraZeneca and Sanofi, has an extended half-life, which may allow one dose to confer protection throughout a season. The only approved option to prevent RSV, palivizumab (Synagis), is used for high-risk infants, and five injections are needed to cover a viral season.
Nearly 1,500 infants in more than 20 countries studied
To assess the effectiveness of nirsevimab in late-preterm and term infants, investigators at 160 sites randomly assigned 1,490 babies born at a gestational age of at least 35 weeks to receive an intramuscular injection of nirsevimab or placebo.
During the 150 days after injection, medically attended RSV-associated lower respiratory tract infections occurred in 12 of 994 infants who received nirsevimab, compared with 25 of 496 babies who received placebo (1.2% vs. 5%).
Six of 994 infants who received nirsevimab were hospitalized for RSV-associated lower respiratory tract infections, compared with 8 of 496 infants in the placebo group (0.6% vs. 1.6%; P = .07). The proportion of children hospitalized for any respiratory illness as a result of RSV was 0.9% among those who received nirsevimab, compared with 2.2% among those who received placebo.
Serious adverse events occurred in 6.8% of the nirsevimab group and 7.3% of the placebo group. None of these events, including three deaths in the nirsevimab group, was considered related to nirsevimab or placebo, according to the researchers. One infant who received nirsevimab had a generalized macular rash without systemic features that did not require treatment and resolved in 20 days, they said.
Antidrug antibodies were detected in 6.1% of the nirsevimab group and in 1.1% of the placebo group. These antidrug antibodies tended to develop later and did not affect nirsevimab pharmacokinetics during the RSV season, the researchers reported. How they might affect subsequent doses of nirsevimab is not known, they added.
In a separate report in the journal, researcher Joseph Domachowske, MD, SUNY Upstate Medical University, Syracuse, New York, and colleagues described safety results from an ongoing study of nirsevimab that includes infants with congenital heart disease, chronic lung disease, and prematurity.
In this trial, infants received nirsevimab or palivizumab, and the treatments appeared to have similar safety profiles, the authors reported.
Other approaches to RSV protection include passive antibodies acquired from maternal vaccination in pregnancy and active vaccination of infants.
The publication follows news last month that GlaxoSmithKline is pausing a maternal RSV vaccine trial, which “had the same goal of protecting babies against severe RSV infection,” said Louis Bont, MD, PhD, with University Medical Center Utrecht, the Netherlands.
RSV infection is one of the deadliest diseases during infancy, and the nirsevimab trial, conducted in more than 20 countries, is “gamechanging,” Dr. Bont told this news organization. Still, researchers will need to monitor for RSV resistance to this treatment, he said.
Whether nirsevimab prevents the development of reactive airway disease and asthma is another open question, he said.
“Finally, we need to keep in mind that RSV mortality is almost limited to the developing world, and it is unlikely that this novel drug will become available to these countries in the coming years,” Dr. Bont said. “Nevertheless, nirsevimab has the potential to seriously decrease the annual overwhelming number of RSV infected babies.”
Nirsevimab may have advantages in low- and middle-income countries, including its potential to be incorporated into established immunization programs and to be given seasonally, said Amy Sarah Ginsburg, MD, MPH, of the University of Washington, Seattle. “However, cost remains a significant factor, as does susceptibility to pathogen escape,” she said.
MedImmune/AstraZeneca and Sanofi funded the nirsevimab studies. UMC Utrecht has received research grants and fees for advisory work from AstraZeneca for RSV-related work by Bont.
A version of this article first appeared on Medscape.com.
A single injection of the experimental agent nirsevimab ahead of respiratory syncytial virus (RSV) season protects healthy infants from lower respiratory tract infections associated with the pathogen, according to the results of a phase 3 study.
A previously published trial showed that a single dose of nirsevimab was effective in preterm infants. The ability to protect all babies from RSV, which causes bronchiolitis and pneumonia and is a leading cause of hospitalization for this age group, “would be a paradigm shift in the approach to this disease,” William Muller, MD, PhD, of the Lurie Children’s Hospital of Chicago and a coauthor of the study, said in a statement.
The primary endpoint of the study was medically attended lower respiratory tract infections linked to RSV. The single injection of nirsevimab was associated with a 74.5% reduction in such infections (P < .001), according to Dr. Muller’s group, who published their findings March 2 in the New England Journal of Medicine.
Nirsevimab, a monoclonal antibody to the RSV fusion protein being developed by AstraZeneca and Sanofi, has an extended half-life, which may allow one dose to confer protection throughout a season. The only approved option to prevent RSV, palivizumab (Synagis), is used for high-risk infants, and five injections are needed to cover a viral season.
Nearly 1,500 infants in more than 20 countries studied
To assess the effectiveness of nirsevimab in late-preterm and term infants, investigators at 160 sites randomly assigned 1,490 babies born at a gestational age of at least 35 weeks to receive an intramuscular injection of nirsevimab or placebo.
During the 150 days after injection, medically attended RSV-associated lower respiratory tract infections occurred in 12 of 994 infants who received nirsevimab, compared with 25 of 496 babies who received placebo (1.2% vs. 5%).
Six of 994 infants who received nirsevimab were hospitalized for RSV-associated lower respiratory tract infections, compared with 8 of 496 infants in the placebo group (0.6% vs. 1.6%; P = .07). The proportion of children hospitalized for any respiratory illness as a result of RSV was 0.9% among those who received nirsevimab, compared with 2.2% among those who received placebo.
Serious adverse events occurred in 6.8% of the nirsevimab group and 7.3% of the placebo group. None of these events, including three deaths in the nirsevimab group, was considered related to nirsevimab or placebo, according to the researchers. One infant who received nirsevimab had a generalized macular rash without systemic features that did not require treatment and resolved in 20 days, they said.
Antidrug antibodies were detected in 6.1% of the nirsevimab group and in 1.1% of the placebo group. These antidrug antibodies tended to develop later and did not affect nirsevimab pharmacokinetics during the RSV season, the researchers reported. How they might affect subsequent doses of nirsevimab is not known, they added.
In a separate report in the journal, researcher Joseph Domachowske, MD, SUNY Upstate Medical University, Syracuse, New York, and colleagues described safety results from an ongoing study of nirsevimab that includes infants with congenital heart disease, chronic lung disease, and prematurity.
In this trial, infants received nirsevimab or palivizumab, and the treatments appeared to have similar safety profiles, the authors reported.
Other approaches to RSV protection include passive antibodies acquired from maternal vaccination in pregnancy and active vaccination of infants.
The publication follows news last month that GlaxoSmithKline is pausing a maternal RSV vaccine trial, which “had the same goal of protecting babies against severe RSV infection,” said Louis Bont, MD, PhD, with University Medical Center Utrecht, the Netherlands.
RSV infection is one of the deadliest diseases during infancy, and the nirsevimab trial, conducted in more than 20 countries, is “gamechanging,” Dr. Bont told this news organization. Still, researchers will need to monitor for RSV resistance to this treatment, he said.
Whether nirsevimab prevents the development of reactive airway disease and asthma is another open question, he said.
“Finally, we need to keep in mind that RSV mortality is almost limited to the developing world, and it is unlikely that this novel drug will become available to these countries in the coming years,” Dr. Bont said. “Nevertheless, nirsevimab has the potential to seriously decrease the annual overwhelming number of RSV infected babies.”
Nirsevimab may have advantages in low- and middle-income countries, including its potential to be incorporated into established immunization programs and to be given seasonally, said Amy Sarah Ginsburg, MD, MPH, of the University of Washington, Seattle. “However, cost remains a significant factor, as does susceptibility to pathogen escape,” she said.
MedImmune/AstraZeneca and Sanofi funded the nirsevimab studies. UMC Utrecht has received research grants and fees for advisory work from AstraZeneca for RSV-related work by Bont.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Epidural may lower odds of severe maternal birth complications
Use of neuraxial analgesia for vaginal delivery is associated with a 14% decreased risk for severe maternal morbidity, in part from a reduction in postpartum hemorrhage, new research shows.
The findings indicate that increasing the use of epidural or combined spinal-epidural analgesia may improve maternal health outcomes, especially for Hispanic, Black, and uninsured women who are less likely than White women to receive these interventions, according to the researchers, who published their findings online in JAMA Network Open.
About 80% of non-Hispanic White women receive neuraxial analgesia during labor in the United States, compared with 70% of non-Hispanic Black women and 65% of Hispanic women, according to birth certificate data. Among women without health insurance, half receive epidurals.
Programs that inform pregnant women about epidural use, expand Medicaid, and provide in-house obstetric anesthesia teams “may improve patient participation in clinical decision making and access to care,” study author Guohua Li, MD, DrPH, of Columbia University, New York, said in a statement about the research.
Earlier data from France showed that neuraxial analgesia is associated with reduced risk for severe postpartum hemorrhage. To examine the association between labor neuraxial analgesia and severe maternal morbidity in the United States, Dr. Li and colleagues analyzed more than 575,000 vaginal deliveries in New York hospitals between 2010 and 2017; about half (47.4%) of the women received epidurals during labor.
The researchers focused on severe maternal morbidity, including 16 complications, such as heart failure and sepsis, and five procedures, including hysterectomy and ventilation.
They also considered patient characteristics and comorbidities and hospital-related factors to identify patients who were at higher risk for injury or death.
Severe maternal morbidity occurred in 1.3% of the women. Of the 7,712 women with severe morbidity, more than one in three (35.6%) experienced postpartum hemorrhage.
The overall incidence of severe maternal morbidity was 1.3% among women who received an epidural injection and 1.4% among those who did not. In a weighted analysis, the adjusted odds ratio of severe maternal morbidity associated with epidurals was 0.86 (95% confidence interval, 0.82-0.90).
The study is limited by its observational design and does not prove causation, the authors acknowledged.
“Labor neuraxial analgesia may facilitate early evaluation and management of the third stage of labor to avoid escalation of postpartum hemorrhaging into grave complications and death,” study author Jean Guglielminotti, MD, PhD, an anesthesiologist at Columbia University, said in a statement.
Concerning trends
The Department of Health & Human Services has labeled severe maternal morbidity a public health priority. Recent data from the Centers for Disease Control and Prevention show an increase in maternal mortality rates and worsening disparities by race and ethnicity.
According to the CDC, 861 women died of maternal causes in 2020, up from 754 in 2019. The rate of maternal mortality increased from 20.1 to 23.8 deaths per 100,000 live births.
For Black women, however, the maternal mortality rate was far higher: 55.3 deaths per 100,000 live births – nearly triple the figure of 19.1 per 100,000 for White women. Between 2019 and 2020, the mortality rate increased significantly for Black and Hispanic women, but not White mothers.
Researchers affiliated with University of Toronto and the Hospital for Sick Children agreed in an accompanying editorial that more access to neuraxial labor analgesia for vaginal delivery might improve maternal health outcomes and “may be a strategy well worth pursuing in public health policy.”
The intervention is relatively safe and can “alleviate discomfort and distress,” they wrote.
Neuraxial anesthesia in surgical procedures has been shown to decrease the risk for complications like deep vein thrombosis, pulmonary embolus, transfusion requirements, and kidney failure, said editorialists Evelina Pankiv, MD; Alan Yang, MSc; and Kazuyoshi Aoyama, MD, PhD.
Benefits potentially could stem from improving blood flow, mitigating hypercoagulation, or reducing surgical stress response. But there are rare risks to consider as well, including hemorrhage, infection, and neurologic injury, they added.
Guglielminotti disclosed grants from the National Institute on Minority Health and Health Disparities. Dr. Aoyama reported receiving grants from the Perioperative Services Facilitator Grant Program and Hospital for Sick Children. The other authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Use of neuraxial analgesia for vaginal delivery is associated with a 14% decreased risk for severe maternal morbidity, in part from a reduction in postpartum hemorrhage, new research shows.
The findings indicate that increasing the use of epidural or combined spinal-epidural analgesia may improve maternal health outcomes, especially for Hispanic, Black, and uninsured women who are less likely than White women to receive these interventions, according to the researchers, who published their findings online in JAMA Network Open.
About 80% of non-Hispanic White women receive neuraxial analgesia during labor in the United States, compared with 70% of non-Hispanic Black women and 65% of Hispanic women, according to birth certificate data. Among women without health insurance, half receive epidurals.
Programs that inform pregnant women about epidural use, expand Medicaid, and provide in-house obstetric anesthesia teams “may improve patient participation in clinical decision making and access to care,” study author Guohua Li, MD, DrPH, of Columbia University, New York, said in a statement about the research.
Earlier data from France showed that neuraxial analgesia is associated with reduced risk for severe postpartum hemorrhage. To examine the association between labor neuraxial analgesia and severe maternal morbidity in the United States, Dr. Li and colleagues analyzed more than 575,000 vaginal deliveries in New York hospitals between 2010 and 2017; about half (47.4%) of the women received epidurals during labor.
The researchers focused on severe maternal morbidity, including 16 complications, such as heart failure and sepsis, and five procedures, including hysterectomy and ventilation.
They also considered patient characteristics and comorbidities and hospital-related factors to identify patients who were at higher risk for injury or death.
Severe maternal morbidity occurred in 1.3% of the women. Of the 7,712 women with severe morbidity, more than one in three (35.6%) experienced postpartum hemorrhage.
The overall incidence of severe maternal morbidity was 1.3% among women who received an epidural injection and 1.4% among those who did not. In a weighted analysis, the adjusted odds ratio of severe maternal morbidity associated with epidurals was 0.86 (95% confidence interval, 0.82-0.90).
The study is limited by its observational design and does not prove causation, the authors acknowledged.
“Labor neuraxial analgesia may facilitate early evaluation and management of the third stage of labor to avoid escalation of postpartum hemorrhaging into grave complications and death,” study author Jean Guglielminotti, MD, PhD, an anesthesiologist at Columbia University, said in a statement.
Concerning trends
The Department of Health & Human Services has labeled severe maternal morbidity a public health priority. Recent data from the Centers for Disease Control and Prevention show an increase in maternal mortality rates and worsening disparities by race and ethnicity.
According to the CDC, 861 women died of maternal causes in 2020, up from 754 in 2019. The rate of maternal mortality increased from 20.1 to 23.8 deaths per 100,000 live births.
For Black women, however, the maternal mortality rate was far higher: 55.3 deaths per 100,000 live births – nearly triple the figure of 19.1 per 100,000 for White women. Between 2019 and 2020, the mortality rate increased significantly for Black and Hispanic women, but not White mothers.
Researchers affiliated with University of Toronto and the Hospital for Sick Children agreed in an accompanying editorial that more access to neuraxial labor analgesia for vaginal delivery might improve maternal health outcomes and “may be a strategy well worth pursuing in public health policy.”
The intervention is relatively safe and can “alleviate discomfort and distress,” they wrote.
Neuraxial anesthesia in surgical procedures has been shown to decrease the risk for complications like deep vein thrombosis, pulmonary embolus, transfusion requirements, and kidney failure, said editorialists Evelina Pankiv, MD; Alan Yang, MSc; and Kazuyoshi Aoyama, MD, PhD.
Benefits potentially could stem from improving blood flow, mitigating hypercoagulation, or reducing surgical stress response. But there are rare risks to consider as well, including hemorrhage, infection, and neurologic injury, they added.
Guglielminotti disclosed grants from the National Institute on Minority Health and Health Disparities. Dr. Aoyama reported receiving grants from the Perioperative Services Facilitator Grant Program and Hospital for Sick Children. The other authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Use of neuraxial analgesia for vaginal delivery is associated with a 14% decreased risk for severe maternal morbidity, in part from a reduction in postpartum hemorrhage, new research shows.
The findings indicate that increasing the use of epidural or combined spinal-epidural analgesia may improve maternal health outcomes, especially for Hispanic, Black, and uninsured women who are less likely than White women to receive these interventions, according to the researchers, who published their findings online in JAMA Network Open.
About 80% of non-Hispanic White women receive neuraxial analgesia during labor in the United States, compared with 70% of non-Hispanic Black women and 65% of Hispanic women, according to birth certificate data. Among women without health insurance, half receive epidurals.
Programs that inform pregnant women about epidural use, expand Medicaid, and provide in-house obstetric anesthesia teams “may improve patient participation in clinical decision making and access to care,” study author Guohua Li, MD, DrPH, of Columbia University, New York, said in a statement about the research.
Earlier data from France showed that neuraxial analgesia is associated with reduced risk for severe postpartum hemorrhage. To examine the association between labor neuraxial analgesia and severe maternal morbidity in the United States, Dr. Li and colleagues analyzed more than 575,000 vaginal deliveries in New York hospitals between 2010 and 2017; about half (47.4%) of the women received epidurals during labor.
The researchers focused on severe maternal morbidity, including 16 complications, such as heart failure and sepsis, and five procedures, including hysterectomy and ventilation.
They also considered patient characteristics and comorbidities and hospital-related factors to identify patients who were at higher risk for injury or death.
Severe maternal morbidity occurred in 1.3% of the women. Of the 7,712 women with severe morbidity, more than one in three (35.6%) experienced postpartum hemorrhage.
The overall incidence of severe maternal morbidity was 1.3% among women who received an epidural injection and 1.4% among those who did not. In a weighted analysis, the adjusted odds ratio of severe maternal morbidity associated with epidurals was 0.86 (95% confidence interval, 0.82-0.90).
The study is limited by its observational design and does not prove causation, the authors acknowledged.
“Labor neuraxial analgesia may facilitate early evaluation and management of the third stage of labor to avoid escalation of postpartum hemorrhaging into grave complications and death,” study author Jean Guglielminotti, MD, PhD, an anesthesiologist at Columbia University, said in a statement.
Concerning trends
The Department of Health & Human Services has labeled severe maternal morbidity a public health priority. Recent data from the Centers for Disease Control and Prevention show an increase in maternal mortality rates and worsening disparities by race and ethnicity.
According to the CDC, 861 women died of maternal causes in 2020, up from 754 in 2019. The rate of maternal mortality increased from 20.1 to 23.8 deaths per 100,000 live births.
For Black women, however, the maternal mortality rate was far higher: 55.3 deaths per 100,000 live births – nearly triple the figure of 19.1 per 100,000 for White women. Between 2019 and 2020, the mortality rate increased significantly for Black and Hispanic women, but not White mothers.
Researchers affiliated with University of Toronto and the Hospital for Sick Children agreed in an accompanying editorial that more access to neuraxial labor analgesia for vaginal delivery might improve maternal health outcomes and “may be a strategy well worth pursuing in public health policy.”
The intervention is relatively safe and can “alleviate discomfort and distress,” they wrote.
Neuraxial anesthesia in surgical procedures has been shown to decrease the risk for complications like deep vein thrombosis, pulmonary embolus, transfusion requirements, and kidney failure, said editorialists Evelina Pankiv, MD; Alan Yang, MSc; and Kazuyoshi Aoyama, MD, PhD.
Benefits potentially could stem from improving blood flow, mitigating hypercoagulation, or reducing surgical stress response. But there are rare risks to consider as well, including hemorrhage, infection, and neurologic injury, they added.
Guglielminotti disclosed grants from the National Institute on Minority Health and Health Disparities. Dr. Aoyama reported receiving grants from the Perioperative Services Facilitator Grant Program and Hospital for Sick Children. The other authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Treatment for BV, trichomoniasis approved for adolescents
The antimicrobial agent, marketed as Solosec, was first approved in 2017 as a treatment for BV in adult women. In 2021, it was approved for the treatment of trichomoniasis in adult men and women.
Lupin Pharmaceuticals, which manufactures the drug, announced the expanded approval for adolescents in a news release.
The medication is meant to be taken as a single dose. It comes in a packet that should be sprinkled onto applesauce, yogurt, or pudding and consumed without chewing or crunching.
The treatment option may help “address gaps in care related to adherence,” said Tom Merriam, an executive director with Lupin.
Bacterial vaginosis is a common vaginal infection. Trichomoniasis is the most common nonviral, curable STI in the United States. Sexual partners of patients with trichomoniasis can be treated at the same time.
Vulvovaginal candidiasis is one of the possible side effects of secnidazole treatment, the drug’s label notes.
The antimicrobial agent, marketed as Solosec, was first approved in 2017 as a treatment for BV in adult women. In 2021, it was approved for the treatment of trichomoniasis in adult men and women.
Lupin Pharmaceuticals, which manufactures the drug, announced the expanded approval for adolescents in a news release.
The medication is meant to be taken as a single dose. It comes in a packet that should be sprinkled onto applesauce, yogurt, or pudding and consumed without chewing or crunching.
The treatment option may help “address gaps in care related to adherence,” said Tom Merriam, an executive director with Lupin.
Bacterial vaginosis is a common vaginal infection. Trichomoniasis is the most common nonviral, curable STI in the United States. Sexual partners of patients with trichomoniasis can be treated at the same time.
Vulvovaginal candidiasis is one of the possible side effects of secnidazole treatment, the drug’s label notes.
The antimicrobial agent, marketed as Solosec, was first approved in 2017 as a treatment for BV in adult women. In 2021, it was approved for the treatment of trichomoniasis in adult men and women.
Lupin Pharmaceuticals, which manufactures the drug, announced the expanded approval for adolescents in a news release.
The medication is meant to be taken as a single dose. It comes in a packet that should be sprinkled onto applesauce, yogurt, or pudding and consumed without chewing or crunching.
The treatment option may help “address gaps in care related to adherence,” said Tom Merriam, an executive director with Lupin.
Bacterial vaginosis is a common vaginal infection. Trichomoniasis is the most common nonviral, curable STI in the United States. Sexual partners of patients with trichomoniasis can be treated at the same time.
Vulvovaginal candidiasis is one of the possible side effects of secnidazole treatment, the drug’s label notes.
Strangulation deaths spur FDA alert on pediatric enteral feeding kits
Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.
The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.
Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.
“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.
Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s health care provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.
Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.
The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.
“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”
Parents and health care providers can report injuries caused by these devices to the FDA.
A version of this article first appeared on Medscape.com.
Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.
The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.
Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.
“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.
Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s health care provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.
Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.
The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.
“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”
Parents and health care providers can report injuries caused by these devices to the FDA.
A version of this article first appeared on Medscape.com.
Enteral feeding kits pose a risk for strangulation in children, according to a safety alert from the U.S. Food and Drug Administration. The safety alert was prompted by two deaths linked to the medical devices.
The alert cites the deaths in 2021 of two toddlers who were strangled by tubes in the feeding sets that had become wrapped around their necks.
Clinicians should discuss the risk of strangulation with colleagues and caregivers and encourage them to take steps to keep tubing away from children as much as possible, the agency advised in a Feb. 8, 2022, safety communication.
“When caring for pediatric patients who receive enteral feeding and as part of an individual risk assessment, be aware of the risk of strangulation from the feeding set tubing and follow protocols to monitor medical line safety,” the FDA warned.
Parents should be aware of the risk and avoid leaving tubing where infants or children can become entangled, to the extent that is possible. They also should tell their child’s health care provider if their child has ever been tangled in the tubing and discuss precautions to ensure that tubing does not get wrapped around the neck, as well as any related concerns.
Enteral feeding sets provide nutrition to people who are unable meet their nutritional needs by eating or swallowing. Tubing delivers nutrition formulas, using gravity or a pump, directly to the stomach or small intestine through the nose, mouth, or an opening in the abdomen.
The two reported deaths involved children under the age of 2 years who were found with tubing wrapped around their necks after brief periods when their caregivers were not directly monitoring them. One report described the unsupervised period as about 10 minutes.
“While the FDA believes that death or serious injury from strangulation with enteral feeding set tubing in children is rare, health care providers and caregivers should be aware that these events can and do occur,” according to the alert. “It is also possible that some cases have not been reported to the FDA.”
Parents and health care providers can report injuries caused by these devices to the FDA.
A version of this article first appeared on Medscape.com.
Researchers eye cannabis for gynecologic pain
Many women use cannabis to help manage gynecologic pain conditions.
When patients ask or tell clinicians about this treatment approach, however, few if any controlled trials exist to inform medical guidance.
A recent review of studies in this area presents a “thorough analysis of this very relevant topic,” said Erin A. Blake, MD, of Presbyterian Cancer Care, Rio Rancho, N.M..
The findings “are consistent with my anecdotal clinical findings as well as the results of my own research,” Dr. Blake said. “Cannabis products represent an underutilized but likely effective modality to relieve pain and other symptoms experienced by our patients.”
Mostly in the dark
Cannabis products “are unregulated and the data we have surrounding them is extremely limited due to outdated federal laws,” said Dr. Blake, who in 2019 described nonprescription cannabis use for symptom management by women with gynecologic malignancies. “Our ability to practice evidence-based medicine related to cannabis products will be limited until we are legally and financially able to design trials to evaluate them in a controlled fashion.”
For the new review, Jenell S. Coleman, MD, MPH, with Johns Hopkins University, Baltimore, and colleagues, identified 16 studies since 1990, including Dr. Blake’s, that examined the use of cannabinoids for managing pain from gynecologic conditions.
Dr. Coleman and her coauthors, Angela L. Liang and Erin L. Gingher, analyzed eight cross-sectional studies, six prospective studies, and two randomized controlled trials.
Patients who used cannabis tended to do so “multiple times per week, and they used a variety of delivery methods and a wide range of doses,” the authors said. “One of the most common reasons for cannabis use was pain management, and all the cross-sectional studies found that most women reported pain relief with cannabis use, especially among women who used a combination of CBD plus THC compared with either cannabinoid alone.”
Cross-sectional studies included patients with chronic pelvic pain (in two of the studies), vulvodynia (one), endometriosis (four), and gynecologic malignancy (two). These studies included between 36 and 3,426 participants and were conducted in the United States, Canada, Australia, and New Zealand.
In one Australian study, for example, Armour and colleagues asked 484 patients with endometriosis to rate the effectiveness of self-management strategies, including cannabis, heat, diet, and exercise, for reducing pelvic pain. Cannabis was used by 13% of the participants and had the highest average effectiveness rating: 7.6 on a 10-point scale.
In some cases, patients who use cannabis may decrease their use of other pain medications, the review found.
Cannabis side effects may include dry mouth, sleepiness, increased appetite, palpitations, and a “high” associated with THC.
Enhancing endogenous cannabinoids
The six prospective cohort studies and two randomized controlled trials examined the effectiveness of compounds – including palmitoylethanolamide (PEA) and a fatty acid amide hydrolase inhibitor – that can enhance endogenous cannabinoids.
Studies of PEA combined with antioxidants showed that these treatments significantly decreased pain from primary dysmenorrhea, pelvic pain, and interstitial cystitis. PEA-combination medications were well tolerated, with nausea and spotting as potential side effects.
On the other hand, a study that assessed a fatty acid amide hydrolase inhibitor found that it did not decrease pain from interstitial cystitis.
Dr. Coleman began reviewing the endocannabinoid system and cannabis research after hearing from patients who were using cannabis for pelvic pain.
Seeing various preclinical data that suggest cannabis could be useful for pain conditions came as a surprise.
Still, the existing evidence base for clinical effectiveness is poor quality, Dr. Coleman said in an interview. Rigorous trials are needed.
“It is a whole field that is just waiting for the U.S. to do something in terms of legalization so that we can actually study to see, does this make sense?” Dr. Coleman said.
Cannabis should not be used while pregnant
In a recent meta-analysis based on data from nearly 60,000 individuals, women who used marijuana during pregnancy were at increased risk for adverse neonatal outcomes such as low birth weight and preterm birth. Study author Greg J. Marchand, MD, of the Marchand Institute for Minimally Invasive Surgery, Mesa, Ariz., noted that the results will force some difficult decisions for mothers who use marijuana to treat medical problems, and that there may not be good substitute treatments for some of these conditions, especially chronic pain and anxiety.
Dr. Coleman disclosed investments in a cannabis exchange-traded fund. Dr. Blake and Dr. Marchand had no relevant financial disclosures.
Many women use cannabis to help manage gynecologic pain conditions.
When patients ask or tell clinicians about this treatment approach, however, few if any controlled trials exist to inform medical guidance.
A recent review of studies in this area presents a “thorough analysis of this very relevant topic,” said Erin A. Blake, MD, of Presbyterian Cancer Care, Rio Rancho, N.M..
The findings “are consistent with my anecdotal clinical findings as well as the results of my own research,” Dr. Blake said. “Cannabis products represent an underutilized but likely effective modality to relieve pain and other symptoms experienced by our patients.”
Mostly in the dark
Cannabis products “are unregulated and the data we have surrounding them is extremely limited due to outdated federal laws,” said Dr. Blake, who in 2019 described nonprescription cannabis use for symptom management by women with gynecologic malignancies. “Our ability to practice evidence-based medicine related to cannabis products will be limited until we are legally and financially able to design trials to evaluate them in a controlled fashion.”
For the new review, Jenell S. Coleman, MD, MPH, with Johns Hopkins University, Baltimore, and colleagues, identified 16 studies since 1990, including Dr. Blake’s, that examined the use of cannabinoids for managing pain from gynecologic conditions.
Dr. Coleman and her coauthors, Angela L. Liang and Erin L. Gingher, analyzed eight cross-sectional studies, six prospective studies, and two randomized controlled trials.
Patients who used cannabis tended to do so “multiple times per week, and they used a variety of delivery methods and a wide range of doses,” the authors said. “One of the most common reasons for cannabis use was pain management, and all the cross-sectional studies found that most women reported pain relief with cannabis use, especially among women who used a combination of CBD plus THC compared with either cannabinoid alone.”
Cross-sectional studies included patients with chronic pelvic pain (in two of the studies), vulvodynia (one), endometriosis (four), and gynecologic malignancy (two). These studies included between 36 and 3,426 participants and were conducted in the United States, Canada, Australia, and New Zealand.
In one Australian study, for example, Armour and colleagues asked 484 patients with endometriosis to rate the effectiveness of self-management strategies, including cannabis, heat, diet, and exercise, for reducing pelvic pain. Cannabis was used by 13% of the participants and had the highest average effectiveness rating: 7.6 on a 10-point scale.
In some cases, patients who use cannabis may decrease their use of other pain medications, the review found.
Cannabis side effects may include dry mouth, sleepiness, increased appetite, palpitations, and a “high” associated with THC.
Enhancing endogenous cannabinoids
The six prospective cohort studies and two randomized controlled trials examined the effectiveness of compounds – including palmitoylethanolamide (PEA) and a fatty acid amide hydrolase inhibitor – that can enhance endogenous cannabinoids.
Studies of PEA combined with antioxidants showed that these treatments significantly decreased pain from primary dysmenorrhea, pelvic pain, and interstitial cystitis. PEA-combination medications were well tolerated, with nausea and spotting as potential side effects.
On the other hand, a study that assessed a fatty acid amide hydrolase inhibitor found that it did not decrease pain from interstitial cystitis.
Dr. Coleman began reviewing the endocannabinoid system and cannabis research after hearing from patients who were using cannabis for pelvic pain.
Seeing various preclinical data that suggest cannabis could be useful for pain conditions came as a surprise.
Still, the existing evidence base for clinical effectiveness is poor quality, Dr. Coleman said in an interview. Rigorous trials are needed.
“It is a whole field that is just waiting for the U.S. to do something in terms of legalization so that we can actually study to see, does this make sense?” Dr. Coleman said.
Cannabis should not be used while pregnant
In a recent meta-analysis based on data from nearly 60,000 individuals, women who used marijuana during pregnancy were at increased risk for adverse neonatal outcomes such as low birth weight and preterm birth. Study author Greg J. Marchand, MD, of the Marchand Institute for Minimally Invasive Surgery, Mesa, Ariz., noted that the results will force some difficult decisions for mothers who use marijuana to treat medical problems, and that there may not be good substitute treatments for some of these conditions, especially chronic pain and anxiety.
Dr. Coleman disclosed investments in a cannabis exchange-traded fund. Dr. Blake and Dr. Marchand had no relevant financial disclosures.
Many women use cannabis to help manage gynecologic pain conditions.
When patients ask or tell clinicians about this treatment approach, however, few if any controlled trials exist to inform medical guidance.
A recent review of studies in this area presents a “thorough analysis of this very relevant topic,” said Erin A. Blake, MD, of Presbyterian Cancer Care, Rio Rancho, N.M..
The findings “are consistent with my anecdotal clinical findings as well as the results of my own research,” Dr. Blake said. “Cannabis products represent an underutilized but likely effective modality to relieve pain and other symptoms experienced by our patients.”
Mostly in the dark
Cannabis products “are unregulated and the data we have surrounding them is extremely limited due to outdated federal laws,” said Dr. Blake, who in 2019 described nonprescription cannabis use for symptom management by women with gynecologic malignancies. “Our ability to practice evidence-based medicine related to cannabis products will be limited until we are legally and financially able to design trials to evaluate them in a controlled fashion.”
For the new review, Jenell S. Coleman, MD, MPH, with Johns Hopkins University, Baltimore, and colleagues, identified 16 studies since 1990, including Dr. Blake’s, that examined the use of cannabinoids for managing pain from gynecologic conditions.
Dr. Coleman and her coauthors, Angela L. Liang and Erin L. Gingher, analyzed eight cross-sectional studies, six prospective studies, and two randomized controlled trials.
Patients who used cannabis tended to do so “multiple times per week, and they used a variety of delivery methods and a wide range of doses,” the authors said. “One of the most common reasons for cannabis use was pain management, and all the cross-sectional studies found that most women reported pain relief with cannabis use, especially among women who used a combination of CBD plus THC compared with either cannabinoid alone.”
Cross-sectional studies included patients with chronic pelvic pain (in two of the studies), vulvodynia (one), endometriosis (four), and gynecologic malignancy (two). These studies included between 36 and 3,426 participants and were conducted in the United States, Canada, Australia, and New Zealand.
In one Australian study, for example, Armour and colleagues asked 484 patients with endometriosis to rate the effectiveness of self-management strategies, including cannabis, heat, diet, and exercise, for reducing pelvic pain. Cannabis was used by 13% of the participants and had the highest average effectiveness rating: 7.6 on a 10-point scale.
In some cases, patients who use cannabis may decrease their use of other pain medications, the review found.
Cannabis side effects may include dry mouth, sleepiness, increased appetite, palpitations, and a “high” associated with THC.
Enhancing endogenous cannabinoids
The six prospective cohort studies and two randomized controlled trials examined the effectiveness of compounds – including palmitoylethanolamide (PEA) and a fatty acid amide hydrolase inhibitor – that can enhance endogenous cannabinoids.
Studies of PEA combined with antioxidants showed that these treatments significantly decreased pain from primary dysmenorrhea, pelvic pain, and interstitial cystitis. PEA-combination medications were well tolerated, with nausea and spotting as potential side effects.
On the other hand, a study that assessed a fatty acid amide hydrolase inhibitor found that it did not decrease pain from interstitial cystitis.
Dr. Coleman began reviewing the endocannabinoid system and cannabis research after hearing from patients who were using cannabis for pelvic pain.
Seeing various preclinical data that suggest cannabis could be useful for pain conditions came as a surprise.
Still, the existing evidence base for clinical effectiveness is poor quality, Dr. Coleman said in an interview. Rigorous trials are needed.
“It is a whole field that is just waiting for the U.S. to do something in terms of legalization so that we can actually study to see, does this make sense?” Dr. Coleman said.
Cannabis should not be used while pregnant
In a recent meta-analysis based on data from nearly 60,000 individuals, women who used marijuana during pregnancy were at increased risk for adverse neonatal outcomes such as low birth weight and preterm birth. Study author Greg J. Marchand, MD, of the Marchand Institute for Minimally Invasive Surgery, Mesa, Ariz., noted that the results will force some difficult decisions for mothers who use marijuana to treat medical problems, and that there may not be good substitute treatments for some of these conditions, especially chronic pain and anxiety.
Dr. Coleman disclosed investments in a cannabis exchange-traded fund. Dr. Blake and Dr. Marchand had no relevant financial disclosures.
FROM OBSTETRICS & GYNECOLOGY
Tech can help teens connect with docs about sexual health
Maria Trent, MD, MPH, was studying ways clinicians can leverage technology to care for adolescents years before COVID-19 exposed the challenges and advantages of telehealth.
Dr. Trent, a pediatrician and adolescent medicine specialist and professor of pediatrics at Johns Hopkins University, Baltimore, has long believed that the phones in her patients’ pockets have the potential to improve the sexual health of youth. The pandemic has only made that view stronger.
“They’re a generation that’s really wired and online,” Dr. Trent told this news organization. “I think that we can meet them in that space.”
Her research has incorporated texting, apps, and videos. Out of necessity, technology increasingly became part of patient care during the pandemic. “We had to stretch our ability to do some basic triage and assessments of patients online,” Dr. Trent said.
Even when clinics are closed, doctors might be able to provide initial care remotely, such as writing prescriptions to manage symptoms or directing patients to a lab for testing.
Telemedicine could allow a clinician to guide a teenager who thinks they might be pregnant to take a store-bought test and avoid possible exposure to COVID-19 in the ED, for instance.
But doctors have concerns about the legal and practical limits of privacy and confidentiality. Who else is at home listening to a phone conversation? Are parents accessing the patient’s online portal? Will parents receive an explanation of benefits that lists testing for a sexually transmitted infection, or see a testing kit that is delivered to their home?
When a young patient needs in-person care, transportation can be a barrier. And then there’s the matter of clinicians being able to bill for telehealth services.
Practices are learning how to navigate these issues, and relevant laws vary by state.
“I think this is going to become part of standard practice,” Dr. Trent said. “I think we have to do the hard work to make sure that it’s safe, that it’s accessible, and that it is actually improving care.”
Texts, apps, videos
In one early study, Dr. Trent and colleagues found that showing adolescents with pelvic inflammatory disease a 6-minute video may improve treatment rates for their sexual partners.
Another study provided preliminary evidence that text messaging support might improve clinic attendance for moderately long-acting reversible contraception.
A third trial showed that adolescents and young adults with pelvic inflammatory disease who were randomly assigned to receive text-message prompts to take their medications and provide information about the doses they consumed had greater decreases in Neisseria gonorrhoeae and Chlamydia trachomatis infections, compared with patients who received standard care.
Dr. Trent and coinvestigators are assessing a technology-based intervention for youth with HIV, in which patients can use an app to submit videos of themselves taking antiretroviral therapy and report any side effects. The technology provides a way to monitor patients remotely and support them between visits, she said.
Will pandemic-driven options remain?
In 2020, Laura D. Lindberg, PhD, principal research scientist at the Guttmacher Institute in New York, and coauthors discussed the possible ramifications of the pandemic on the sexual and reproductive health of adolescents and young adults.
If telemedicine options driven by COVID-19 are here to stay, adolescents and young adults could be “the age group most likely to continue that approach rather than returning to traditional in-person visits,” the researchers wrote. “Innovations in health care service provision, such as use of telemedicine and obtaining contraceptives and STI testing by mail, will help expand access to [sexual and reproductive health] care for young people.”
At the 2021 annual conference of the American Academy of Pediatrics, Dr. Trent described telehealth as a viable way to provide sexual and reproductive health care to adolescents and young adults, including anticipatory guidance, contraception counseling, coordination of follow-up care and testing, and connecting patients to resources.
Her presentation cited several websites that can help patients receive testing for STIs, including Yes Means Test, the Centers for Disease Control and Prevention’s GetTested page, and I Want the Kit. Planned Parenthood has telehealth options, and the Kaiser Family Foundation compiled information about 26 online platforms that were providing contraception or STI services.
Who else is in the room?
“There’s only so much time in the day and so many patients you can see, regardless of whether you have telehealth or not,” said David L. Bell, MD, MPH, president of the Society for Adolescent Health and Medicine and a coauthor of the Perspectives on Sexual and Reproductive Health paper. In addition, “you never know who else is in the room” with the patient on the other end, added Dr. Bell, a professor of population and family health and pediatrics at the Columbia University Medical Center and medical director of the Young Men’s Clinic, both in New York.
In some respects, young patients may not be able to participate in telehealth visits the same way they would in a medical office, Dr. Trent acknowledged. Encouraging the use of headphones is one way to help protect confidentiality when talking with patients who are at home and might not be alone.
But if patients are able to find a private space for remote visits, they might be more open than usual. In that way, telemedicine could provide additional opportunities to address issues like substance use disorders and mental health, as well, she said.
“Then, if they need something, we have to problem solve,” Dr. Trent said. Next steps may involve engaging a parent or getting the patient to a lab or the clinic.
Sex ed may be lacking
The Perspectives article also raised concerns that the pandemic might exacerbate shortcomings in sex education, which already may have been lacking.
“Before the pandemic, schools were a key source of formal sex education for young people,” the authors wrote. “Sex education, which was already limited in many areas of the country, has likely not been included in the national shift to online learning. Even when in-person schooling resumes, missed sex education instruction is unlikely to be made up, given the modest attention it received prior to the pandemic.”
A recently published study in the Journal of Adolescent Health indicates that American teenagers currently receive less formal sex education than they did 25 years ago, with “troubling” inequities by race.
Researchers surveyed adolescents about what they had learned about topics such as how to say no to sex, methods of birth control and where to get them, and STIs.
Dr. Lindberg and Leslie M. Kantor, PhD, MPH, professor and chair of the department of urban-global public health at Rutgers University, Newark, N.J., conducted the analysis.
“Pediatricians and other health care providers that work with children and adolescents have a critical role to play in providing information about sexuality to both the patients and to the parents,” said Dr. Kantor, who also coauthored the Perspectives article with Dr. Lindberg and Dr. Bell. The new research “shows that doctors play an even more critical role, because they can’t assume that their patients are going to get the information that they need in a timely way from schools.”
By age 15, 21% of girls and 20% of boys have had sexual intercourse at least once, according to data from the 2015-2017 National Survey of Family Growth. By age 17, the percentages were 53% of girls and 48% of boys. By age 20, the percentages were 79% of women and 77% of men. The CDC’s 2021 guidelines on treatment and screening for STIs note that prevalence rates of certain infections – such as chlamydia and gonorrhea in females – are highest among adolescents and young adults.
Those trends underscore the importance of counseling on sexual health that clinicians can provide, but time constraints may limit how much they can discuss in a single session with a patient. To cover all topics that are important to parents and patients, doctors may need to discuss sexual and reproductive health sooner and more frequently.
Young people are getting more and more explicit information from their phones and media, yet educators are giving them less information to navigate these topics and learn what’s real, Dr. Kantor said. That mismatch can be toxic. In a December 2021 interview with Howard Stern, the pop star Billie Eilish said she started watching pornography at about age 11 and frequently watched videos that were violent. “I think it really destroyed my brain and I feel incredibly devastated that I was exposed to so much porn,” Ms. Eilish told Mr. Stern.
Researchers and a psychologist told CNN that the singer’s story may be typical. It also highlights a need to be aware of kids’ online activities and to have conversations about how pornography may not depict healthy interactions, they said.
Beyond discussing a plan for preventing pregnancy and STIs, Dr. Kantor encouraged discussions about what constitutes healthy relationships, as well as check-ins about intimate partner violence and how romantic relationships are going.
“I think for pediatricians and for parents, it’s a muscle,” she said. “As you bring up these topics more, listen, and respond, you get more comfortable with it.”
Dr. Trent has served as an advisory board member on a sexual health council for Trojan (Church & Dwight Company) and has received research funding from Hologic and research supplies from SpeeDx. Dr. Bell has received funds from the Merck Foundation, Merck, and Gilead. Dr. Kantor had no disclosures.
A version of this article first appeared on Medscape.com.
Maria Trent, MD, MPH, was studying ways clinicians can leverage technology to care for adolescents years before COVID-19 exposed the challenges and advantages of telehealth.
Dr. Trent, a pediatrician and adolescent medicine specialist and professor of pediatrics at Johns Hopkins University, Baltimore, has long believed that the phones in her patients’ pockets have the potential to improve the sexual health of youth. The pandemic has only made that view stronger.
“They’re a generation that’s really wired and online,” Dr. Trent told this news organization. “I think that we can meet them in that space.”
Her research has incorporated texting, apps, and videos. Out of necessity, technology increasingly became part of patient care during the pandemic. “We had to stretch our ability to do some basic triage and assessments of patients online,” Dr. Trent said.
Even when clinics are closed, doctors might be able to provide initial care remotely, such as writing prescriptions to manage symptoms or directing patients to a lab for testing.
Telemedicine could allow a clinician to guide a teenager who thinks they might be pregnant to take a store-bought test and avoid possible exposure to COVID-19 in the ED, for instance.
But doctors have concerns about the legal and practical limits of privacy and confidentiality. Who else is at home listening to a phone conversation? Are parents accessing the patient’s online portal? Will parents receive an explanation of benefits that lists testing for a sexually transmitted infection, or see a testing kit that is delivered to their home?
When a young patient needs in-person care, transportation can be a barrier. And then there’s the matter of clinicians being able to bill for telehealth services.
Practices are learning how to navigate these issues, and relevant laws vary by state.
“I think this is going to become part of standard practice,” Dr. Trent said. “I think we have to do the hard work to make sure that it’s safe, that it’s accessible, and that it is actually improving care.”
Texts, apps, videos
In one early study, Dr. Trent and colleagues found that showing adolescents with pelvic inflammatory disease a 6-minute video may improve treatment rates for their sexual partners.
Another study provided preliminary evidence that text messaging support might improve clinic attendance for moderately long-acting reversible contraception.
A third trial showed that adolescents and young adults with pelvic inflammatory disease who were randomly assigned to receive text-message prompts to take their medications and provide information about the doses they consumed had greater decreases in Neisseria gonorrhoeae and Chlamydia trachomatis infections, compared with patients who received standard care.
Dr. Trent and coinvestigators are assessing a technology-based intervention for youth with HIV, in which patients can use an app to submit videos of themselves taking antiretroviral therapy and report any side effects. The technology provides a way to monitor patients remotely and support them between visits, she said.
Will pandemic-driven options remain?
In 2020, Laura D. Lindberg, PhD, principal research scientist at the Guttmacher Institute in New York, and coauthors discussed the possible ramifications of the pandemic on the sexual and reproductive health of adolescents and young adults.
If telemedicine options driven by COVID-19 are here to stay, adolescents and young adults could be “the age group most likely to continue that approach rather than returning to traditional in-person visits,” the researchers wrote. “Innovations in health care service provision, such as use of telemedicine and obtaining contraceptives and STI testing by mail, will help expand access to [sexual and reproductive health] care for young people.”
At the 2021 annual conference of the American Academy of Pediatrics, Dr. Trent described telehealth as a viable way to provide sexual and reproductive health care to adolescents and young adults, including anticipatory guidance, contraception counseling, coordination of follow-up care and testing, and connecting patients to resources.
Her presentation cited several websites that can help patients receive testing for STIs, including Yes Means Test, the Centers for Disease Control and Prevention’s GetTested page, and I Want the Kit. Planned Parenthood has telehealth options, and the Kaiser Family Foundation compiled information about 26 online platforms that were providing contraception or STI services.
Who else is in the room?
“There’s only so much time in the day and so many patients you can see, regardless of whether you have telehealth or not,” said David L. Bell, MD, MPH, president of the Society for Adolescent Health and Medicine and a coauthor of the Perspectives on Sexual and Reproductive Health paper. In addition, “you never know who else is in the room” with the patient on the other end, added Dr. Bell, a professor of population and family health and pediatrics at the Columbia University Medical Center and medical director of the Young Men’s Clinic, both in New York.
In some respects, young patients may not be able to participate in telehealth visits the same way they would in a medical office, Dr. Trent acknowledged. Encouraging the use of headphones is one way to help protect confidentiality when talking with patients who are at home and might not be alone.
But if patients are able to find a private space for remote visits, they might be more open than usual. In that way, telemedicine could provide additional opportunities to address issues like substance use disorders and mental health, as well, she said.
“Then, if they need something, we have to problem solve,” Dr. Trent said. Next steps may involve engaging a parent or getting the patient to a lab or the clinic.
Sex ed may be lacking
The Perspectives article also raised concerns that the pandemic might exacerbate shortcomings in sex education, which already may have been lacking.
“Before the pandemic, schools were a key source of formal sex education for young people,” the authors wrote. “Sex education, which was already limited in many areas of the country, has likely not been included in the national shift to online learning. Even when in-person schooling resumes, missed sex education instruction is unlikely to be made up, given the modest attention it received prior to the pandemic.”
A recently published study in the Journal of Adolescent Health indicates that American teenagers currently receive less formal sex education than they did 25 years ago, with “troubling” inequities by race.
Researchers surveyed adolescents about what they had learned about topics such as how to say no to sex, methods of birth control and where to get them, and STIs.
Dr. Lindberg and Leslie M. Kantor, PhD, MPH, professor and chair of the department of urban-global public health at Rutgers University, Newark, N.J., conducted the analysis.
“Pediatricians and other health care providers that work with children and adolescents have a critical role to play in providing information about sexuality to both the patients and to the parents,” said Dr. Kantor, who also coauthored the Perspectives article with Dr. Lindberg and Dr. Bell. The new research “shows that doctors play an even more critical role, because they can’t assume that their patients are going to get the information that they need in a timely way from schools.”
By age 15, 21% of girls and 20% of boys have had sexual intercourse at least once, according to data from the 2015-2017 National Survey of Family Growth. By age 17, the percentages were 53% of girls and 48% of boys. By age 20, the percentages were 79% of women and 77% of men. The CDC’s 2021 guidelines on treatment and screening for STIs note that prevalence rates of certain infections – such as chlamydia and gonorrhea in females – are highest among adolescents and young adults.
Those trends underscore the importance of counseling on sexual health that clinicians can provide, but time constraints may limit how much they can discuss in a single session with a patient. To cover all topics that are important to parents and patients, doctors may need to discuss sexual and reproductive health sooner and more frequently.
Young people are getting more and more explicit information from their phones and media, yet educators are giving them less information to navigate these topics and learn what’s real, Dr. Kantor said. That mismatch can be toxic. In a December 2021 interview with Howard Stern, the pop star Billie Eilish said she started watching pornography at about age 11 and frequently watched videos that were violent. “I think it really destroyed my brain and I feel incredibly devastated that I was exposed to so much porn,” Ms. Eilish told Mr. Stern.
Researchers and a psychologist told CNN that the singer’s story may be typical. It also highlights a need to be aware of kids’ online activities and to have conversations about how pornography may not depict healthy interactions, they said.
Beyond discussing a plan for preventing pregnancy and STIs, Dr. Kantor encouraged discussions about what constitutes healthy relationships, as well as check-ins about intimate partner violence and how romantic relationships are going.
“I think for pediatricians and for parents, it’s a muscle,” she said. “As you bring up these topics more, listen, and respond, you get more comfortable with it.”
Dr. Trent has served as an advisory board member on a sexual health council for Trojan (Church & Dwight Company) and has received research funding from Hologic and research supplies from SpeeDx. Dr. Bell has received funds from the Merck Foundation, Merck, and Gilead. Dr. Kantor had no disclosures.
A version of this article first appeared on Medscape.com.
Maria Trent, MD, MPH, was studying ways clinicians can leverage technology to care for adolescents years before COVID-19 exposed the challenges and advantages of telehealth.
Dr. Trent, a pediatrician and adolescent medicine specialist and professor of pediatrics at Johns Hopkins University, Baltimore, has long believed that the phones in her patients’ pockets have the potential to improve the sexual health of youth. The pandemic has only made that view stronger.
“They’re a generation that’s really wired and online,” Dr. Trent told this news organization. “I think that we can meet them in that space.”
Her research has incorporated texting, apps, and videos. Out of necessity, technology increasingly became part of patient care during the pandemic. “We had to stretch our ability to do some basic triage and assessments of patients online,” Dr. Trent said.
Even when clinics are closed, doctors might be able to provide initial care remotely, such as writing prescriptions to manage symptoms or directing patients to a lab for testing.
Telemedicine could allow a clinician to guide a teenager who thinks they might be pregnant to take a store-bought test and avoid possible exposure to COVID-19 in the ED, for instance.
But doctors have concerns about the legal and practical limits of privacy and confidentiality. Who else is at home listening to a phone conversation? Are parents accessing the patient’s online portal? Will parents receive an explanation of benefits that lists testing for a sexually transmitted infection, or see a testing kit that is delivered to their home?
When a young patient needs in-person care, transportation can be a barrier. And then there’s the matter of clinicians being able to bill for telehealth services.
Practices are learning how to navigate these issues, and relevant laws vary by state.
“I think this is going to become part of standard practice,” Dr. Trent said. “I think we have to do the hard work to make sure that it’s safe, that it’s accessible, and that it is actually improving care.”
Texts, apps, videos
In one early study, Dr. Trent and colleagues found that showing adolescents with pelvic inflammatory disease a 6-minute video may improve treatment rates for their sexual partners.
Another study provided preliminary evidence that text messaging support might improve clinic attendance for moderately long-acting reversible contraception.
A third trial showed that adolescents and young adults with pelvic inflammatory disease who were randomly assigned to receive text-message prompts to take their medications and provide information about the doses they consumed had greater decreases in Neisseria gonorrhoeae and Chlamydia trachomatis infections, compared with patients who received standard care.
Dr. Trent and coinvestigators are assessing a technology-based intervention for youth with HIV, in which patients can use an app to submit videos of themselves taking antiretroviral therapy and report any side effects. The technology provides a way to monitor patients remotely and support them between visits, she said.
Will pandemic-driven options remain?
In 2020, Laura D. Lindberg, PhD, principal research scientist at the Guttmacher Institute in New York, and coauthors discussed the possible ramifications of the pandemic on the sexual and reproductive health of adolescents and young adults.
If telemedicine options driven by COVID-19 are here to stay, adolescents and young adults could be “the age group most likely to continue that approach rather than returning to traditional in-person visits,” the researchers wrote. “Innovations in health care service provision, such as use of telemedicine and obtaining contraceptives and STI testing by mail, will help expand access to [sexual and reproductive health] care for young people.”
At the 2021 annual conference of the American Academy of Pediatrics, Dr. Trent described telehealth as a viable way to provide sexual and reproductive health care to adolescents and young adults, including anticipatory guidance, contraception counseling, coordination of follow-up care and testing, and connecting patients to resources.
Her presentation cited several websites that can help patients receive testing for STIs, including Yes Means Test, the Centers for Disease Control and Prevention’s GetTested page, and I Want the Kit. Planned Parenthood has telehealth options, and the Kaiser Family Foundation compiled information about 26 online platforms that were providing contraception or STI services.
Who else is in the room?
“There’s only so much time in the day and so many patients you can see, regardless of whether you have telehealth or not,” said David L. Bell, MD, MPH, president of the Society for Adolescent Health and Medicine and a coauthor of the Perspectives on Sexual and Reproductive Health paper. In addition, “you never know who else is in the room” with the patient on the other end, added Dr. Bell, a professor of population and family health and pediatrics at the Columbia University Medical Center and medical director of the Young Men’s Clinic, both in New York.
In some respects, young patients may not be able to participate in telehealth visits the same way they would in a medical office, Dr. Trent acknowledged. Encouraging the use of headphones is one way to help protect confidentiality when talking with patients who are at home and might not be alone.
But if patients are able to find a private space for remote visits, they might be more open than usual. In that way, telemedicine could provide additional opportunities to address issues like substance use disorders and mental health, as well, she said.
“Then, if they need something, we have to problem solve,” Dr. Trent said. Next steps may involve engaging a parent or getting the patient to a lab or the clinic.
Sex ed may be lacking
The Perspectives article also raised concerns that the pandemic might exacerbate shortcomings in sex education, which already may have been lacking.
“Before the pandemic, schools were a key source of formal sex education for young people,” the authors wrote. “Sex education, which was already limited in many areas of the country, has likely not been included in the national shift to online learning. Even when in-person schooling resumes, missed sex education instruction is unlikely to be made up, given the modest attention it received prior to the pandemic.”
A recently published study in the Journal of Adolescent Health indicates that American teenagers currently receive less formal sex education than they did 25 years ago, with “troubling” inequities by race.
Researchers surveyed adolescents about what they had learned about topics such as how to say no to sex, methods of birth control and where to get them, and STIs.
Dr. Lindberg and Leslie M. Kantor, PhD, MPH, professor and chair of the department of urban-global public health at Rutgers University, Newark, N.J., conducted the analysis.
“Pediatricians and other health care providers that work with children and adolescents have a critical role to play in providing information about sexuality to both the patients and to the parents,” said Dr. Kantor, who also coauthored the Perspectives article with Dr. Lindberg and Dr. Bell. The new research “shows that doctors play an even more critical role, because they can’t assume that their patients are going to get the information that they need in a timely way from schools.”
By age 15, 21% of girls and 20% of boys have had sexual intercourse at least once, according to data from the 2015-2017 National Survey of Family Growth. By age 17, the percentages were 53% of girls and 48% of boys. By age 20, the percentages were 79% of women and 77% of men. The CDC’s 2021 guidelines on treatment and screening for STIs note that prevalence rates of certain infections – such as chlamydia and gonorrhea in females – are highest among adolescents and young adults.
Those trends underscore the importance of counseling on sexual health that clinicians can provide, but time constraints may limit how much they can discuss in a single session with a patient. To cover all topics that are important to parents and patients, doctors may need to discuss sexual and reproductive health sooner and more frequently.
Young people are getting more and more explicit information from their phones and media, yet educators are giving them less information to navigate these topics and learn what’s real, Dr. Kantor said. That mismatch can be toxic. In a December 2021 interview with Howard Stern, the pop star Billie Eilish said she started watching pornography at about age 11 and frequently watched videos that were violent. “I think it really destroyed my brain and I feel incredibly devastated that I was exposed to so much porn,” Ms. Eilish told Mr. Stern.
Researchers and a psychologist told CNN that the singer’s story may be typical. It also highlights a need to be aware of kids’ online activities and to have conversations about how pornography may not depict healthy interactions, they said.
Beyond discussing a plan for preventing pregnancy and STIs, Dr. Kantor encouraged discussions about what constitutes healthy relationships, as well as check-ins about intimate partner violence and how romantic relationships are going.
“I think for pediatricians and for parents, it’s a muscle,” she said. “As you bring up these topics more, listen, and respond, you get more comfortable with it.”
Dr. Trent has served as an advisory board member on a sexual health council for Trojan (Church & Dwight Company) and has received research funding from Hologic and research supplies from SpeeDx. Dr. Bell has received funds from the Merck Foundation, Merck, and Gilead. Dr. Kantor had no disclosures.
A version of this article first appeared on Medscape.com.
How can doctors help kids recover from COVID-19 school disruptions?
Physicians may be able to help students get back on track after the pandemic derailed normal schooling, a developmental and behavioral pediatrician suggests.
The disruptions especially affected vulnerable students, such as those with disabilities and those affected by poverty. But academic setbacks occurred across grades and demographics.
“What we know is that, if it was bad before COVID, things are much worse now,” Eric Tridas, MD, said at the annual meeting of the American Academy of Pediatrics. “The pandemic disproportionately affected vulnerable populations. It exacerbated their learning and mental health problems to a high degree.”
In an effort to help kids catch up, pediatricians can provide information to parents about approaches to accelerated academic instruction, Dr. Tridas suggested. They also can monitor for depression and anxiety, and provide appropriate referrals and, if needed, medication, said Dr. Tridas, who is a member of the National Joint Committee on Learning Disabilities.
Doctors also can collaborate with educators to establish schoolwide plans to address mental health problems, he said.
Dr. Tridas focused on vulnerable populations, including students with neurodevelopmental disorders, as well as students of color, English language learners, and Indigenous populations. But other research presented at the AAP meeting focused on challenges that college students in general encountered during the pandemic.
Nelson Chow, a research intern at Cohen Children’s Medical Center in New Hyde Park, N.Y., and colleagues surveyed college students in June 2020 about academic barriers when their schools switched to virtual learning.
Nearly 80% of the 307 respondents had difficulties concentrating. Many students also agreed that responsibilities at home (57.6%), mental health issues (46.3%), family relationships (37.8%), financial hardships (31.5%), and limited Internet access (25.1%) were among the factors that posed academic barriers.
A larger proportion of Hispanic students reported that responsibilities at home were a challenge, compared with non-Hispanic students, the researchers found.
“It is especially important to have a particular awareness of the cultural and socioeconomic factors that may impact students’ outcomes,” Mr. Chow said in a news release highlighting the research.
Although studies indicate that the pandemic led to academic losses across the board in terms of students not learning as much as usual, these setbacks were more pronounced for vulnerable populations, Dr. Tridas said.
What can busy pediatricians do? “We can at least inquire about how the kids are doing educationally, and with mental health. That’s it. If we do that, we are doing an awful lot.”
Education
Dr. Tridas pointed meeting attendees to a report from the National Center for Learning Disabilities, “Promising Practices to Accelerate Learning for Students with Disabilities During COVID-19 and Beyond,” that he said could be a helpful resource for pediatricians, parents, and educators who want to learn more about accelerated learning approaches.
Research indicates that these strategies “may help in a situation like this,” Dr. Tridas said.
Accelerated approaches typically simplify the curriculum to focus on essential reading, writing, and math skills that most students should acquire by third grade, while capitalizing on students’ strengths and interests.
Despite vulnerable students having fallen farther behind academically, they likely are doing the same thing in school that they were doing before COVID-19, “which was not working to begin with,” he said. “That is why I try to provide parents and pediatricians with ways of ... recognizing when appropriate instruction is being provided.”
Sharing this information does not necessarily mean that schools will implement those strategies, or that schools are not applying them already. Still, making parents aware of these approaches can help, he said.
Emotional health
Social isolation, loss of routine and structure, more screen time, and changes in sleeping and eating patterns during the pandemic are factors that may have exacerbated mental health problems in students.
Vulnerable populations are at higher risk for these issues, and it will be important to monitor these kids for suicidal ideation and depression, especially in middle school and high school, Dr. Tridas said.
Doctors should establish alliances with mental health providers in their communities if they are not able to provide cognitive-behavioral therapy or medication management in their own practices.
And at home and at school, children should have structure and consistency, positive enforcement of appropriate conduct, and a safe environment that allows them to fail and try again, Dr. Tridas said.
Dr. Tridas and Mr. Chow had no relevant financial disclosures.
Physicians may be able to help students get back on track after the pandemic derailed normal schooling, a developmental and behavioral pediatrician suggests.
The disruptions especially affected vulnerable students, such as those with disabilities and those affected by poverty. But academic setbacks occurred across grades and demographics.
“What we know is that, if it was bad before COVID, things are much worse now,” Eric Tridas, MD, said at the annual meeting of the American Academy of Pediatrics. “The pandemic disproportionately affected vulnerable populations. It exacerbated their learning and mental health problems to a high degree.”
In an effort to help kids catch up, pediatricians can provide information to parents about approaches to accelerated academic instruction, Dr. Tridas suggested. They also can monitor for depression and anxiety, and provide appropriate referrals and, if needed, medication, said Dr. Tridas, who is a member of the National Joint Committee on Learning Disabilities.
Doctors also can collaborate with educators to establish schoolwide plans to address mental health problems, he said.
Dr. Tridas focused on vulnerable populations, including students with neurodevelopmental disorders, as well as students of color, English language learners, and Indigenous populations. But other research presented at the AAP meeting focused on challenges that college students in general encountered during the pandemic.
Nelson Chow, a research intern at Cohen Children’s Medical Center in New Hyde Park, N.Y., and colleagues surveyed college students in June 2020 about academic barriers when their schools switched to virtual learning.
Nearly 80% of the 307 respondents had difficulties concentrating. Many students also agreed that responsibilities at home (57.6%), mental health issues (46.3%), family relationships (37.8%), financial hardships (31.5%), and limited Internet access (25.1%) were among the factors that posed academic barriers.
A larger proportion of Hispanic students reported that responsibilities at home were a challenge, compared with non-Hispanic students, the researchers found.
“It is especially important to have a particular awareness of the cultural and socioeconomic factors that may impact students’ outcomes,” Mr. Chow said in a news release highlighting the research.
Although studies indicate that the pandemic led to academic losses across the board in terms of students not learning as much as usual, these setbacks were more pronounced for vulnerable populations, Dr. Tridas said.
What can busy pediatricians do? “We can at least inquire about how the kids are doing educationally, and with mental health. That’s it. If we do that, we are doing an awful lot.”
Education
Dr. Tridas pointed meeting attendees to a report from the National Center for Learning Disabilities, “Promising Practices to Accelerate Learning for Students with Disabilities During COVID-19 and Beyond,” that he said could be a helpful resource for pediatricians, parents, and educators who want to learn more about accelerated learning approaches.
Research indicates that these strategies “may help in a situation like this,” Dr. Tridas said.
Accelerated approaches typically simplify the curriculum to focus on essential reading, writing, and math skills that most students should acquire by third grade, while capitalizing on students’ strengths and interests.
Despite vulnerable students having fallen farther behind academically, they likely are doing the same thing in school that they were doing before COVID-19, “which was not working to begin with,” he said. “That is why I try to provide parents and pediatricians with ways of ... recognizing when appropriate instruction is being provided.”
Sharing this information does not necessarily mean that schools will implement those strategies, or that schools are not applying them already. Still, making parents aware of these approaches can help, he said.
Emotional health
Social isolation, loss of routine and structure, more screen time, and changes in sleeping and eating patterns during the pandemic are factors that may have exacerbated mental health problems in students.
Vulnerable populations are at higher risk for these issues, and it will be important to monitor these kids for suicidal ideation and depression, especially in middle school and high school, Dr. Tridas said.
Doctors should establish alliances with mental health providers in their communities if they are not able to provide cognitive-behavioral therapy or medication management in their own practices.
And at home and at school, children should have structure and consistency, positive enforcement of appropriate conduct, and a safe environment that allows them to fail and try again, Dr. Tridas said.
Dr. Tridas and Mr. Chow had no relevant financial disclosures.
Physicians may be able to help students get back on track after the pandemic derailed normal schooling, a developmental and behavioral pediatrician suggests.
The disruptions especially affected vulnerable students, such as those with disabilities and those affected by poverty. But academic setbacks occurred across grades and demographics.
“What we know is that, if it was bad before COVID, things are much worse now,” Eric Tridas, MD, said at the annual meeting of the American Academy of Pediatrics. “The pandemic disproportionately affected vulnerable populations. It exacerbated their learning and mental health problems to a high degree.”
In an effort to help kids catch up, pediatricians can provide information to parents about approaches to accelerated academic instruction, Dr. Tridas suggested. They also can monitor for depression and anxiety, and provide appropriate referrals and, if needed, medication, said Dr. Tridas, who is a member of the National Joint Committee on Learning Disabilities.
Doctors also can collaborate with educators to establish schoolwide plans to address mental health problems, he said.
Dr. Tridas focused on vulnerable populations, including students with neurodevelopmental disorders, as well as students of color, English language learners, and Indigenous populations. But other research presented at the AAP meeting focused on challenges that college students in general encountered during the pandemic.
Nelson Chow, a research intern at Cohen Children’s Medical Center in New Hyde Park, N.Y., and colleagues surveyed college students in June 2020 about academic barriers when their schools switched to virtual learning.
Nearly 80% of the 307 respondents had difficulties concentrating. Many students also agreed that responsibilities at home (57.6%), mental health issues (46.3%), family relationships (37.8%), financial hardships (31.5%), and limited Internet access (25.1%) were among the factors that posed academic barriers.
A larger proportion of Hispanic students reported that responsibilities at home were a challenge, compared with non-Hispanic students, the researchers found.
“It is especially important to have a particular awareness of the cultural and socioeconomic factors that may impact students’ outcomes,” Mr. Chow said in a news release highlighting the research.
Although studies indicate that the pandemic led to academic losses across the board in terms of students not learning as much as usual, these setbacks were more pronounced for vulnerable populations, Dr. Tridas said.
What can busy pediatricians do? “We can at least inquire about how the kids are doing educationally, and with mental health. That’s it. If we do that, we are doing an awful lot.”
Education
Dr. Tridas pointed meeting attendees to a report from the National Center for Learning Disabilities, “Promising Practices to Accelerate Learning for Students with Disabilities During COVID-19 and Beyond,” that he said could be a helpful resource for pediatricians, parents, and educators who want to learn more about accelerated learning approaches.
Research indicates that these strategies “may help in a situation like this,” Dr. Tridas said.
Accelerated approaches typically simplify the curriculum to focus on essential reading, writing, and math skills that most students should acquire by third grade, while capitalizing on students’ strengths and interests.
Despite vulnerable students having fallen farther behind academically, they likely are doing the same thing in school that they were doing before COVID-19, “which was not working to begin with,” he said. “That is why I try to provide parents and pediatricians with ways of ... recognizing when appropriate instruction is being provided.”
Sharing this information does not necessarily mean that schools will implement those strategies, or that schools are not applying them already. Still, making parents aware of these approaches can help, he said.
Emotional health
Social isolation, loss of routine and structure, more screen time, and changes in sleeping and eating patterns during the pandemic are factors that may have exacerbated mental health problems in students.
Vulnerable populations are at higher risk for these issues, and it will be important to monitor these kids for suicidal ideation and depression, especially in middle school and high school, Dr. Tridas said.
Doctors should establish alliances with mental health providers in their communities if they are not able to provide cognitive-behavioral therapy or medication management in their own practices.
And at home and at school, children should have structure and consistency, positive enforcement of appropriate conduct, and a safe environment that allows them to fail and try again, Dr. Tridas said.
Dr. Tridas and Mr. Chow had no relevant financial disclosures.
FROM AAP 2021
Kids in foster care get psychotropic meds at ‘alarming’ rates
Children in foster care are far more likely to be prescribed psychotropic medication, compared with children who are not in foster care, an analysis of Medicaid claims data shows.
Different rates of mental health disorders in these groups do not fully explain the “alarming trend,” which persists across psychotropic medication classes, said study author Rachael J. Keefe, MD, MPH.
Dr. Keefe, with Baylor College of Medicine, Houston, and colleagues analyzed Medicaid claims data from two managed care organizations to compare the prevalence of psychotropic medication use among children in foster care versus children insured by Medicaid but not in foster care. The study focused on claims from the same region in southeast Texas between July 2014 and June 2016.
The researchers included 388,914 children in Medicaid and 8,426 children in foster care in their analysis. They excluded children with a seizure or epilepsy diagnosis.
About 8% of children not in foster care received psychotropic medications, compared with 35% of those in foster care.
Children in foster care were 27 times more likely to receive antipsychotic medication (21.2% of children in foster care vs. 0.8% of children not in foster care) and twice as likely to receive antianxiety medication (6% vs. 3%).
For children in foster care, the rate of alpha-agonist use was 15 times higher, the rate of antidepressant use was 13 times higher, the rate of mood stabilizer use was 26 times higher, and the rate of stimulant use was 6 times higher.
The researchers have a limited understanding of the full context in which these medications were prescribed, and psychotropic medications have a role in the treatment of children in foster care, Dr. Keefe acknowledged.
“We have to be careful not to have a knee-jerk reaction” and inappropriately withhold medication from children in foster care, she said in an interview.
But overprescribing has been a concern. Dr. Keefe leads a foster care clinical service at Texas Children’s Hospital in Houston.
“The overprescribing of psychotropic medications to children in foster care is something I feel every day in my clinical practice, but it’s different to see it on paper,” Dr. Keefe said in a news release highlighting the research, which she presented on Oct. 11 at the annual meeting of the American Academy of Pediatrics. “It’s especially shocking to see these dramatic differences in children of preschool and elementary age.”
Misdiagnosis can be a common problem among children in foster care, said Danielle Shaw, MD, a child and adolescent psychiatrist in Camarillo, Calif., during a question-and-answer period following the presentation.
“I see incorrect diagnoses very frequently,” Dr. Shaw said. “The history of trauma or [adverse childhood experiences] is not even included in the assessment. Mood lability from trauma is misdiagnosed as bipolar disorder, despite not meeting criteria. This will justify the use of antipsychotic medication and mood stabilizers. Flashbacks can be mistaken for a psychotic disorder, which again justifies the use of antipsychotic medication.”
Children in foster care have experienced numerous traumatic experiences that affect brain development and the hypothalamic-pituitary-adrenal axis, Dr. Keefe said.
“Although from previous research we know that children in foster care are more likely to carry mental health and developmental disorder diagnoses, this does not account for the significant difference in prescribing practices in this population,” Dr. Keefe said in an interview.
Although the study focused on data in Texas, Dr. Keefe expects similar patterns exist in other regions, based on anecdotal reports. “I work with foster care pediatricians across the country, and many have seen similar concerning trends within their own clinical practices,” she said.
The use of appropriate therapies, minimizing transitions between providers, improved record keeping, the development of deprescribing algorithms, and placement of children in foster care in long-term homes as early as possible are measures that potentially could reduce inappropriate psychotropic prescribing for children in foster care, Dr. Keefe suggested.
The research was funded by a Texas Medical Center Health Policy Research Grant. The study authors and Dr. Shaw had no relevant financial disclosures.
Children in foster care are far more likely to be prescribed psychotropic medication, compared with children who are not in foster care, an analysis of Medicaid claims data shows.
Different rates of mental health disorders in these groups do not fully explain the “alarming trend,” which persists across psychotropic medication classes, said study author Rachael J. Keefe, MD, MPH.
Dr. Keefe, with Baylor College of Medicine, Houston, and colleagues analyzed Medicaid claims data from two managed care organizations to compare the prevalence of psychotropic medication use among children in foster care versus children insured by Medicaid but not in foster care. The study focused on claims from the same region in southeast Texas between July 2014 and June 2016.
The researchers included 388,914 children in Medicaid and 8,426 children in foster care in their analysis. They excluded children with a seizure or epilepsy diagnosis.
About 8% of children not in foster care received psychotropic medications, compared with 35% of those in foster care.
Children in foster care were 27 times more likely to receive antipsychotic medication (21.2% of children in foster care vs. 0.8% of children not in foster care) and twice as likely to receive antianxiety medication (6% vs. 3%).
For children in foster care, the rate of alpha-agonist use was 15 times higher, the rate of antidepressant use was 13 times higher, the rate of mood stabilizer use was 26 times higher, and the rate of stimulant use was 6 times higher.
The researchers have a limited understanding of the full context in which these medications were prescribed, and psychotropic medications have a role in the treatment of children in foster care, Dr. Keefe acknowledged.
“We have to be careful not to have a knee-jerk reaction” and inappropriately withhold medication from children in foster care, she said in an interview.
But overprescribing has been a concern. Dr. Keefe leads a foster care clinical service at Texas Children’s Hospital in Houston.
“The overprescribing of psychotropic medications to children in foster care is something I feel every day in my clinical practice, but it’s different to see it on paper,” Dr. Keefe said in a news release highlighting the research, which she presented on Oct. 11 at the annual meeting of the American Academy of Pediatrics. “It’s especially shocking to see these dramatic differences in children of preschool and elementary age.”
Misdiagnosis can be a common problem among children in foster care, said Danielle Shaw, MD, a child and adolescent psychiatrist in Camarillo, Calif., during a question-and-answer period following the presentation.
“I see incorrect diagnoses very frequently,” Dr. Shaw said. “The history of trauma or [adverse childhood experiences] is not even included in the assessment. Mood lability from trauma is misdiagnosed as bipolar disorder, despite not meeting criteria. This will justify the use of antipsychotic medication and mood stabilizers. Flashbacks can be mistaken for a psychotic disorder, which again justifies the use of antipsychotic medication.”
Children in foster care have experienced numerous traumatic experiences that affect brain development and the hypothalamic-pituitary-adrenal axis, Dr. Keefe said.
“Although from previous research we know that children in foster care are more likely to carry mental health and developmental disorder diagnoses, this does not account for the significant difference in prescribing practices in this population,” Dr. Keefe said in an interview.
Although the study focused on data in Texas, Dr. Keefe expects similar patterns exist in other regions, based on anecdotal reports. “I work with foster care pediatricians across the country, and many have seen similar concerning trends within their own clinical practices,” she said.
The use of appropriate therapies, minimizing transitions between providers, improved record keeping, the development of deprescribing algorithms, and placement of children in foster care in long-term homes as early as possible are measures that potentially could reduce inappropriate psychotropic prescribing for children in foster care, Dr. Keefe suggested.
The research was funded by a Texas Medical Center Health Policy Research Grant. The study authors and Dr. Shaw had no relevant financial disclosures.
Children in foster care are far more likely to be prescribed psychotropic medication, compared with children who are not in foster care, an analysis of Medicaid claims data shows.
Different rates of mental health disorders in these groups do not fully explain the “alarming trend,” which persists across psychotropic medication classes, said study author Rachael J. Keefe, MD, MPH.
Dr. Keefe, with Baylor College of Medicine, Houston, and colleagues analyzed Medicaid claims data from two managed care organizations to compare the prevalence of psychotropic medication use among children in foster care versus children insured by Medicaid but not in foster care. The study focused on claims from the same region in southeast Texas between July 2014 and June 2016.
The researchers included 388,914 children in Medicaid and 8,426 children in foster care in their analysis. They excluded children with a seizure or epilepsy diagnosis.
About 8% of children not in foster care received psychotropic medications, compared with 35% of those in foster care.
Children in foster care were 27 times more likely to receive antipsychotic medication (21.2% of children in foster care vs. 0.8% of children not in foster care) and twice as likely to receive antianxiety medication (6% vs. 3%).
For children in foster care, the rate of alpha-agonist use was 15 times higher, the rate of antidepressant use was 13 times higher, the rate of mood stabilizer use was 26 times higher, and the rate of stimulant use was 6 times higher.
The researchers have a limited understanding of the full context in which these medications were prescribed, and psychotropic medications have a role in the treatment of children in foster care, Dr. Keefe acknowledged.
“We have to be careful not to have a knee-jerk reaction” and inappropriately withhold medication from children in foster care, she said in an interview.
But overprescribing has been a concern. Dr. Keefe leads a foster care clinical service at Texas Children’s Hospital in Houston.
“The overprescribing of psychotropic medications to children in foster care is something I feel every day in my clinical practice, but it’s different to see it on paper,” Dr. Keefe said in a news release highlighting the research, which she presented on Oct. 11 at the annual meeting of the American Academy of Pediatrics. “It’s especially shocking to see these dramatic differences in children of preschool and elementary age.”
Misdiagnosis can be a common problem among children in foster care, said Danielle Shaw, MD, a child and adolescent psychiatrist in Camarillo, Calif., during a question-and-answer period following the presentation.
“I see incorrect diagnoses very frequently,” Dr. Shaw said. “The history of trauma or [adverse childhood experiences] is not even included in the assessment. Mood lability from trauma is misdiagnosed as bipolar disorder, despite not meeting criteria. This will justify the use of antipsychotic medication and mood stabilizers. Flashbacks can be mistaken for a psychotic disorder, which again justifies the use of antipsychotic medication.”
Children in foster care have experienced numerous traumatic experiences that affect brain development and the hypothalamic-pituitary-adrenal axis, Dr. Keefe said.
“Although from previous research we know that children in foster care are more likely to carry mental health and developmental disorder diagnoses, this does not account for the significant difference in prescribing practices in this population,” Dr. Keefe said in an interview.
Although the study focused on data in Texas, Dr. Keefe expects similar patterns exist in other regions, based on anecdotal reports. “I work with foster care pediatricians across the country, and many have seen similar concerning trends within their own clinical practices,” she said.
The use of appropriate therapies, minimizing transitions between providers, improved record keeping, the development of deprescribing algorithms, and placement of children in foster care in long-term homes as early as possible are measures that potentially could reduce inappropriate psychotropic prescribing for children in foster care, Dr. Keefe suggested.
The research was funded by a Texas Medical Center Health Policy Research Grant. The study authors and Dr. Shaw had no relevant financial disclosures.
FROM AAP 2021
‘Baby-wearing’ poses serious injury risks for infants, ED data show
Baby-wearing – carrying a child against your body in a sling, soft carrier, or other device – is associated with benefits like reduced crying and increased breastfeeding, studies have shown.
But this practice also entails risks. Babies can fall out of carriers, or be injured when an adult carrying them falls, for example.
researchers estimated in a study presented at the annual meeting of the American Academy of Pediatrics.
To characterize the epidemiology of these injuries, Samantha J. Rowe, MD, chief resident physician at Walter Reed National Military Medical Center in Bethesda, Md., and colleagues analyzed data from the National Electronic Injury Surveillance System between 2011 and 2020.
They included in their analysis data from patients aged 5 years and younger who sustained an injury associated with a baby-wearing product. Baby harnesses, carriers, slings, framed baby carriers, and soft baby carriers were among the devices included in the study. The researchers used 601 cases to generate national estimates.
An estimated 14,024 patients presented to EDs because of baby-wearing injuries, and 52% of the injuries occurred when a patient fell from the product.
Most injuries (61%) occurred in children aged 5 months and younger; 19.3% of these infants required hospitalization, most often for head injuries.
The investigators found that about 22% of the injuries were associated with a caregiver falling, noted Rachel Y. Moon, MD, who was not involved in the study.
“Carrying a baby changes your center of gravity – and can also obscure your vision of where you’re walking, so adults who use these devices should be cognizant of this,” said Dr. Moon, with the University of Virginia, Charlottesville.
Dr. Rowe often practiced baby-wearing with her daughter, and found that it was beneficial. And studies have demonstrated various benefits of baby-wearing, including improved thermoregulation and glycemic control.
Still, the new analysis illustrates the potential for baby-wearing products “to cause serious injury, especially in infants 5 months and younger,” Dr. Rowe said. “We need to provide more education to caregivers on safe baby-wearing and continue to improve our safety standards for baby-wearing products.”
Study coauthor Patrick T. Reeves, MD, with the Naval Medical Center at San Diego, offered additional guidance in a news release: “Like when buying a new pair of shoes, parents must be educated on the proper sizing, selection, and wear of baby carriers to prevent injury to themselves and their child.”
Parents also need to ensure that the child’s nose and mouth are not obstructed, Dr. Moon
In a recent article discussing the possible benefits of baby-wearing in terms of helping with breastfeeding, Dr. Moon also pointed out further safety considerations: “No matter which carrier is used, for safety reasons, we need to remind parents that the baby should be positioned so that the head is upright and the nose and mouth are not obstructed.”
The researchers and Dr. Moon had no relevant financial disclosures.
Baby-wearing – carrying a child against your body in a sling, soft carrier, or other device – is associated with benefits like reduced crying and increased breastfeeding, studies have shown.
But this practice also entails risks. Babies can fall out of carriers, or be injured when an adult carrying them falls, for example.
researchers estimated in a study presented at the annual meeting of the American Academy of Pediatrics.
To characterize the epidemiology of these injuries, Samantha J. Rowe, MD, chief resident physician at Walter Reed National Military Medical Center in Bethesda, Md., and colleagues analyzed data from the National Electronic Injury Surveillance System between 2011 and 2020.
They included in their analysis data from patients aged 5 years and younger who sustained an injury associated with a baby-wearing product. Baby harnesses, carriers, slings, framed baby carriers, and soft baby carriers were among the devices included in the study. The researchers used 601 cases to generate national estimates.
An estimated 14,024 patients presented to EDs because of baby-wearing injuries, and 52% of the injuries occurred when a patient fell from the product.
Most injuries (61%) occurred in children aged 5 months and younger; 19.3% of these infants required hospitalization, most often for head injuries.
The investigators found that about 22% of the injuries were associated with a caregiver falling, noted Rachel Y. Moon, MD, who was not involved in the study.
“Carrying a baby changes your center of gravity – and can also obscure your vision of where you’re walking, so adults who use these devices should be cognizant of this,” said Dr. Moon, with the University of Virginia, Charlottesville.
Dr. Rowe often practiced baby-wearing with her daughter, and found that it was beneficial. And studies have demonstrated various benefits of baby-wearing, including improved thermoregulation and glycemic control.
Still, the new analysis illustrates the potential for baby-wearing products “to cause serious injury, especially in infants 5 months and younger,” Dr. Rowe said. “We need to provide more education to caregivers on safe baby-wearing and continue to improve our safety standards for baby-wearing products.”
Study coauthor Patrick T. Reeves, MD, with the Naval Medical Center at San Diego, offered additional guidance in a news release: “Like when buying a new pair of shoes, parents must be educated on the proper sizing, selection, and wear of baby carriers to prevent injury to themselves and their child.”
Parents also need to ensure that the child’s nose and mouth are not obstructed, Dr. Moon
In a recent article discussing the possible benefits of baby-wearing in terms of helping with breastfeeding, Dr. Moon also pointed out further safety considerations: “No matter which carrier is used, for safety reasons, we need to remind parents that the baby should be positioned so that the head is upright and the nose and mouth are not obstructed.”
The researchers and Dr. Moon had no relevant financial disclosures.
Baby-wearing – carrying a child against your body in a sling, soft carrier, or other device – is associated with benefits like reduced crying and increased breastfeeding, studies have shown.
But this practice also entails risks. Babies can fall out of carriers, or be injured when an adult carrying them falls, for example.
researchers estimated in a study presented at the annual meeting of the American Academy of Pediatrics.
To characterize the epidemiology of these injuries, Samantha J. Rowe, MD, chief resident physician at Walter Reed National Military Medical Center in Bethesda, Md., and colleagues analyzed data from the National Electronic Injury Surveillance System between 2011 and 2020.
They included in their analysis data from patients aged 5 years and younger who sustained an injury associated with a baby-wearing product. Baby harnesses, carriers, slings, framed baby carriers, and soft baby carriers were among the devices included in the study. The researchers used 601 cases to generate national estimates.
An estimated 14,024 patients presented to EDs because of baby-wearing injuries, and 52% of the injuries occurred when a patient fell from the product.
Most injuries (61%) occurred in children aged 5 months and younger; 19.3% of these infants required hospitalization, most often for head injuries.
The investigators found that about 22% of the injuries were associated with a caregiver falling, noted Rachel Y. Moon, MD, who was not involved in the study.
“Carrying a baby changes your center of gravity – and can also obscure your vision of where you’re walking, so adults who use these devices should be cognizant of this,” said Dr. Moon, with the University of Virginia, Charlottesville.
Dr. Rowe often practiced baby-wearing with her daughter, and found that it was beneficial. And studies have demonstrated various benefits of baby-wearing, including improved thermoregulation and glycemic control.
Still, the new analysis illustrates the potential for baby-wearing products “to cause serious injury, especially in infants 5 months and younger,” Dr. Rowe said. “We need to provide more education to caregivers on safe baby-wearing and continue to improve our safety standards for baby-wearing products.”
Study coauthor Patrick T. Reeves, MD, with the Naval Medical Center at San Diego, offered additional guidance in a news release: “Like when buying a new pair of shoes, parents must be educated on the proper sizing, selection, and wear of baby carriers to prevent injury to themselves and their child.”
Parents also need to ensure that the child’s nose and mouth are not obstructed, Dr. Moon
In a recent article discussing the possible benefits of baby-wearing in terms of helping with breastfeeding, Dr. Moon also pointed out further safety considerations: “No matter which carrier is used, for safety reasons, we need to remind parents that the baby should be positioned so that the head is upright and the nose and mouth are not obstructed.”
The researchers and Dr. Moon had no relevant financial disclosures.
FROM AAP 2021
Adolescents who exercised after a concussion recovered faster in RCT
After a concussion, resuming aerobic exercise relatively early on – at an intensity that does not worsen symptoms – may help young athletes recover sooner, compared with stretching, a randomized controlled trial (RCT) shows.
The study adds to emerging evidence that clinicians should prescribe exercise, rather than strict rest, to facilitate concussion recovery, researchers said.
Tamara McLeod, PhD, ATC, professor and director of athletic training programs at A.T. Still University in Mesa, Ariz., hopes the findings help clinicians see that “this is an approach that should be taken.”
“Too often with concussion, patients are given a laundry list of things they are NOT allowed to do,” including sports, school, and social activities, said Dr. McLeod, who was not involved in the study.
The research, published in The Lancet Child & Adolescent Health, largely replicates the findings of a prior trial while addressing limitations of the previous study’s design, researchers said.
For the trial, John J. Leddy, MD, with the State University of New York at Buffalo and colleagues recruited 118 male and female adolescent athletes aged 13-18 years who had had a sport-related concussion in the past 10 days. Investigators at three community and hospital-affiliated sports medicine concussion centers in the United States randomly assigned the athletes to individualized subsymptom-threshold aerobic exercise (61 participants) or stretching exercise (57 participants) at least 20 minutes per day for up to 4 weeks. Aerobic exercise included walking, jogging, or stationary cycling at home.
“It is important that the general clinician community appreciates that prolonged rest and avoidance of physical activity until spontaneous symptom resolution is no longer an acceptable approach to caring for adolescents with concussion,” Dr. Leddy and coauthors said.
The investigators improved on the “the scientific rigor of their previous RCT by including intention-to-treat and per-protocol analyses, daily symptom reporting, objective exercise adherence measurements, and greater heterogeneity of concussion severity,” said Carolyn A. Emery, PhD, and Jonathan Smirl, PhD, both with the University of Calgary (Alta.), in a related commentary. The new study is the first to show that early targeted heart rate subsymptom-threshold aerobic exercise, relative to stretching, shortened recovery time within 4 weeks after sport-related concussion (hazard ratio, 0.52) when controlling for sex, study site, and average daily exercise time, Dr. Emery and Dr. Smirl said.
A larger proportion of athletes assigned to stretching did not recover by 4 weeks, compared with those assigned to aerobic exercise (32% vs. 21%). The median time to full recovery was longer for the stretching group than for the aerobic exercise group (19 days vs. 14 days).
Among athletes who adhered to their assigned regimens, the differences were more pronounced: The median recovery time was 21 days for the stretching group, compared with 12 days for the aerobic exercise group. The rate of postconcussion symptoms beyond 28 days was 9% in the aerobic exercise group versus 31% in the stretching group, among adherent participants.
More research is needed to establish the efficacy of postconcussion aerobic exercise in adults and for nonsport injury, the researchers noted. Possible mechanisms underlying aerobic exercise’s benefits could include increased parasympathetic autonomic tone, improved cerebral blood flow regulation, or enhanced neuron repair, they suggested.
The right amount and timing of exercise, and doing so at an intensity that does not exacerbate symptoms, may be key. Other research has suggested that too much exercise, too soon may delay recovery, Dr. Emery said in an interview. “But there is now a lot of evidence to support low and moderate levels of physical activity to expedite recovery,” she said.
The study was funded by the American Medical Society for Sports Medicine. The study and commentary authors and Dr. McLeod had no disclosures.
After a concussion, resuming aerobic exercise relatively early on – at an intensity that does not worsen symptoms – may help young athletes recover sooner, compared with stretching, a randomized controlled trial (RCT) shows.
The study adds to emerging evidence that clinicians should prescribe exercise, rather than strict rest, to facilitate concussion recovery, researchers said.
Tamara McLeod, PhD, ATC, professor and director of athletic training programs at A.T. Still University in Mesa, Ariz., hopes the findings help clinicians see that “this is an approach that should be taken.”
“Too often with concussion, patients are given a laundry list of things they are NOT allowed to do,” including sports, school, and social activities, said Dr. McLeod, who was not involved in the study.
The research, published in The Lancet Child & Adolescent Health, largely replicates the findings of a prior trial while addressing limitations of the previous study’s design, researchers said.
For the trial, John J. Leddy, MD, with the State University of New York at Buffalo and colleagues recruited 118 male and female adolescent athletes aged 13-18 years who had had a sport-related concussion in the past 10 days. Investigators at three community and hospital-affiliated sports medicine concussion centers in the United States randomly assigned the athletes to individualized subsymptom-threshold aerobic exercise (61 participants) or stretching exercise (57 participants) at least 20 minutes per day for up to 4 weeks. Aerobic exercise included walking, jogging, or stationary cycling at home.
“It is important that the general clinician community appreciates that prolonged rest and avoidance of physical activity until spontaneous symptom resolution is no longer an acceptable approach to caring for adolescents with concussion,” Dr. Leddy and coauthors said.
The investigators improved on the “the scientific rigor of their previous RCT by including intention-to-treat and per-protocol analyses, daily symptom reporting, objective exercise adherence measurements, and greater heterogeneity of concussion severity,” said Carolyn A. Emery, PhD, and Jonathan Smirl, PhD, both with the University of Calgary (Alta.), in a related commentary. The new study is the first to show that early targeted heart rate subsymptom-threshold aerobic exercise, relative to stretching, shortened recovery time within 4 weeks after sport-related concussion (hazard ratio, 0.52) when controlling for sex, study site, and average daily exercise time, Dr. Emery and Dr. Smirl said.
A larger proportion of athletes assigned to stretching did not recover by 4 weeks, compared with those assigned to aerobic exercise (32% vs. 21%). The median time to full recovery was longer for the stretching group than for the aerobic exercise group (19 days vs. 14 days).
Among athletes who adhered to their assigned regimens, the differences were more pronounced: The median recovery time was 21 days for the stretching group, compared with 12 days for the aerobic exercise group. The rate of postconcussion symptoms beyond 28 days was 9% in the aerobic exercise group versus 31% in the stretching group, among adherent participants.
More research is needed to establish the efficacy of postconcussion aerobic exercise in adults and for nonsport injury, the researchers noted. Possible mechanisms underlying aerobic exercise’s benefits could include increased parasympathetic autonomic tone, improved cerebral blood flow regulation, or enhanced neuron repair, they suggested.
The right amount and timing of exercise, and doing so at an intensity that does not exacerbate symptoms, may be key. Other research has suggested that too much exercise, too soon may delay recovery, Dr. Emery said in an interview. “But there is now a lot of evidence to support low and moderate levels of physical activity to expedite recovery,” she said.
The study was funded by the American Medical Society for Sports Medicine. The study and commentary authors and Dr. McLeod had no disclosures.
After a concussion, resuming aerobic exercise relatively early on – at an intensity that does not worsen symptoms – may help young athletes recover sooner, compared with stretching, a randomized controlled trial (RCT) shows.
The study adds to emerging evidence that clinicians should prescribe exercise, rather than strict rest, to facilitate concussion recovery, researchers said.
Tamara McLeod, PhD, ATC, professor and director of athletic training programs at A.T. Still University in Mesa, Ariz., hopes the findings help clinicians see that “this is an approach that should be taken.”
“Too often with concussion, patients are given a laundry list of things they are NOT allowed to do,” including sports, school, and social activities, said Dr. McLeod, who was not involved in the study.
The research, published in The Lancet Child & Adolescent Health, largely replicates the findings of a prior trial while addressing limitations of the previous study’s design, researchers said.
For the trial, John J. Leddy, MD, with the State University of New York at Buffalo and colleagues recruited 118 male and female adolescent athletes aged 13-18 years who had had a sport-related concussion in the past 10 days. Investigators at three community and hospital-affiliated sports medicine concussion centers in the United States randomly assigned the athletes to individualized subsymptom-threshold aerobic exercise (61 participants) or stretching exercise (57 participants) at least 20 minutes per day for up to 4 weeks. Aerobic exercise included walking, jogging, or stationary cycling at home.
“It is important that the general clinician community appreciates that prolonged rest and avoidance of physical activity until spontaneous symptom resolution is no longer an acceptable approach to caring for adolescents with concussion,” Dr. Leddy and coauthors said.
The investigators improved on the “the scientific rigor of their previous RCT by including intention-to-treat and per-protocol analyses, daily symptom reporting, objective exercise adherence measurements, and greater heterogeneity of concussion severity,” said Carolyn A. Emery, PhD, and Jonathan Smirl, PhD, both with the University of Calgary (Alta.), in a related commentary. The new study is the first to show that early targeted heart rate subsymptom-threshold aerobic exercise, relative to stretching, shortened recovery time within 4 weeks after sport-related concussion (hazard ratio, 0.52) when controlling for sex, study site, and average daily exercise time, Dr. Emery and Dr. Smirl said.
A larger proportion of athletes assigned to stretching did not recover by 4 weeks, compared with those assigned to aerobic exercise (32% vs. 21%). The median time to full recovery was longer for the stretching group than for the aerobic exercise group (19 days vs. 14 days).
Among athletes who adhered to their assigned regimens, the differences were more pronounced: The median recovery time was 21 days for the stretching group, compared with 12 days for the aerobic exercise group. The rate of postconcussion symptoms beyond 28 days was 9% in the aerobic exercise group versus 31% in the stretching group, among adherent participants.
More research is needed to establish the efficacy of postconcussion aerobic exercise in adults and for nonsport injury, the researchers noted. Possible mechanisms underlying aerobic exercise’s benefits could include increased parasympathetic autonomic tone, improved cerebral blood flow regulation, or enhanced neuron repair, they suggested.
The right amount and timing of exercise, and doing so at an intensity that does not exacerbate symptoms, may be key. Other research has suggested that too much exercise, too soon may delay recovery, Dr. Emery said in an interview. “But there is now a lot of evidence to support low and moderate levels of physical activity to expedite recovery,” she said.
The study was funded by the American Medical Society for Sports Medicine. The study and commentary authors and Dr. McLeod had no disclosures.
FROM THE LANCET CHILD & ADOLESCENT HEALTH