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Kindergarten vaccination rates dip below 95% target
Vaccination rates among kindergartners in the United States dipped below the Healthy People 2030 target of 95% in 2020-2021, according to the latest figures from the Centers for Disease Control and Prevention.
Data from 47 states and the District of Columbia, reported in the Morbidity and Mortality Weekly Report, showed the rates dipped by about 1 percentage point, compared with the previous school year for state-required vaccines. Coverage nationally was 93.9% for two doses of the MMR vaccine, 93.6% for the required number of doses of DTaP, and 93.6% for the state-required doses of varicella vaccine.
“This might not sound like much,” Georgina Peacock, MD, MPH, acting director of CDC’s immunization services division said in a press briefing. “But it amounts to at least 35,000 more children across the United States that entered kindergarten without documentation of complete vaccination against common diseases like measles, whooping cough, and chickenpox.”
The report authors, led by Ranee Seither, MPH, with the immunization services division of the CDC’s National Center for Immunization and Respiratory Diseases, said the COVID-19 pandemic played a large part in the dip as children missed doctors’ appointments and states relaxed requirements with remote instruction.
States reported reluctance by parents to schedule well-child appointments and reduced access to office visits as well as longer grace periods or provisional enrollment. There was also less submission of documentation by parents, less time for school nurses to follow-up with students to document vaccines, fewer staff members to conduct kindergarten vaccination coverage assessment, lower response rates from schools, and both extended and compressed kindergarten vaccination coverage data collection schedules.
“There’s a greater proportion of parents who are questioning routine vaccines,” Jason V. Terk, MD, a Texas pediatrician and a spokesman for the American Academy of Pediatrics, told the New York Times. He said misinformation “fed the fire of distrust and skepticism that is really sort of the new pandemic of hesitancy for routine vaccines.”
The authors of the CDC report wrote: “As schools continue to return to in-person learning, enforcement of vaccination policies and follow-up with undervaccinated students are important to improve vaccination coverage.”
They urged schools and immunization programs to reach out to first-time students, including kindergartners and first-graders, and follow up with undervaccinated students.
The rate of people having an exemption from at least one vaccine remained low at 2.2% and the percentage of children with exemptions decreased in 37 states. However, an additional 3.9% who did not have a vaccine exemption were not up to date for MMR, according to the report.
Mississippi and New York had the smallest percentage of exemptions (0.1%) and Idaho had the most (8.2%). In the 2019-2020 school year, 2.5% reported an exemption from at least one vaccine. Nationally, 0.2% of kindergartners had a medical exemption and 1.9% had a nonmedical exemption.
Vaccination rates also differed among states. The New York Times noted that Maryland had a 10% drop in MMR vaccine coverage, while Wisconsin, Georgia, Wyoming, and Kentucky had declines of about 5%.
Among states reporting the measures in 2020-2021, the proportion of kindergartners attending school with no documentation of required vaccinations or exemptions ranged from 0.1% (Pennsylvania and Virginia) to 8.3% (Maryland). The state with the lowest proportion of kindergarteners out of compliance was Florida (0.2%) and Indiana had the highest out-of-compliance rate at 16.6%.
Comparing states’ performance is difficult, the authors noted, because they vary as to which vaccine and number of doses they require and by what date and what documentation they require. They also vary by data collection methods; exemptions allowed; grace period rules and provisional enrollment.
The authors, Dr. Peacock, and Dr. Terk reported no relevant financial disclosures.
Vaccination rates among kindergartners in the United States dipped below the Healthy People 2030 target of 95% in 2020-2021, according to the latest figures from the Centers for Disease Control and Prevention.
Data from 47 states and the District of Columbia, reported in the Morbidity and Mortality Weekly Report, showed the rates dipped by about 1 percentage point, compared with the previous school year for state-required vaccines. Coverage nationally was 93.9% for two doses of the MMR vaccine, 93.6% for the required number of doses of DTaP, and 93.6% for the state-required doses of varicella vaccine.
“This might not sound like much,” Georgina Peacock, MD, MPH, acting director of CDC’s immunization services division said in a press briefing. “But it amounts to at least 35,000 more children across the United States that entered kindergarten without documentation of complete vaccination against common diseases like measles, whooping cough, and chickenpox.”
The report authors, led by Ranee Seither, MPH, with the immunization services division of the CDC’s National Center for Immunization and Respiratory Diseases, said the COVID-19 pandemic played a large part in the dip as children missed doctors’ appointments and states relaxed requirements with remote instruction.
States reported reluctance by parents to schedule well-child appointments and reduced access to office visits as well as longer grace periods or provisional enrollment. There was also less submission of documentation by parents, less time for school nurses to follow-up with students to document vaccines, fewer staff members to conduct kindergarten vaccination coverage assessment, lower response rates from schools, and both extended and compressed kindergarten vaccination coverage data collection schedules.
“There’s a greater proportion of parents who are questioning routine vaccines,” Jason V. Terk, MD, a Texas pediatrician and a spokesman for the American Academy of Pediatrics, told the New York Times. He said misinformation “fed the fire of distrust and skepticism that is really sort of the new pandemic of hesitancy for routine vaccines.”
The authors of the CDC report wrote: “As schools continue to return to in-person learning, enforcement of vaccination policies and follow-up with undervaccinated students are important to improve vaccination coverage.”
They urged schools and immunization programs to reach out to first-time students, including kindergartners and first-graders, and follow up with undervaccinated students.
The rate of people having an exemption from at least one vaccine remained low at 2.2% and the percentage of children with exemptions decreased in 37 states. However, an additional 3.9% who did not have a vaccine exemption were not up to date for MMR, according to the report.
Mississippi and New York had the smallest percentage of exemptions (0.1%) and Idaho had the most (8.2%). In the 2019-2020 school year, 2.5% reported an exemption from at least one vaccine. Nationally, 0.2% of kindergartners had a medical exemption and 1.9% had a nonmedical exemption.
Vaccination rates also differed among states. The New York Times noted that Maryland had a 10% drop in MMR vaccine coverage, while Wisconsin, Georgia, Wyoming, and Kentucky had declines of about 5%.
Among states reporting the measures in 2020-2021, the proportion of kindergartners attending school with no documentation of required vaccinations or exemptions ranged from 0.1% (Pennsylvania and Virginia) to 8.3% (Maryland). The state with the lowest proportion of kindergarteners out of compliance was Florida (0.2%) and Indiana had the highest out-of-compliance rate at 16.6%.
Comparing states’ performance is difficult, the authors noted, because they vary as to which vaccine and number of doses they require and by what date and what documentation they require. They also vary by data collection methods; exemptions allowed; grace period rules and provisional enrollment.
The authors, Dr. Peacock, and Dr. Terk reported no relevant financial disclosures.
Vaccination rates among kindergartners in the United States dipped below the Healthy People 2030 target of 95% in 2020-2021, according to the latest figures from the Centers for Disease Control and Prevention.
Data from 47 states and the District of Columbia, reported in the Morbidity and Mortality Weekly Report, showed the rates dipped by about 1 percentage point, compared with the previous school year for state-required vaccines. Coverage nationally was 93.9% for two doses of the MMR vaccine, 93.6% for the required number of doses of DTaP, and 93.6% for the state-required doses of varicella vaccine.
“This might not sound like much,” Georgina Peacock, MD, MPH, acting director of CDC’s immunization services division said in a press briefing. “But it amounts to at least 35,000 more children across the United States that entered kindergarten without documentation of complete vaccination against common diseases like measles, whooping cough, and chickenpox.”
The report authors, led by Ranee Seither, MPH, with the immunization services division of the CDC’s National Center for Immunization and Respiratory Diseases, said the COVID-19 pandemic played a large part in the dip as children missed doctors’ appointments and states relaxed requirements with remote instruction.
States reported reluctance by parents to schedule well-child appointments and reduced access to office visits as well as longer grace periods or provisional enrollment. There was also less submission of documentation by parents, less time for school nurses to follow-up with students to document vaccines, fewer staff members to conduct kindergarten vaccination coverage assessment, lower response rates from schools, and both extended and compressed kindergarten vaccination coverage data collection schedules.
“There’s a greater proportion of parents who are questioning routine vaccines,” Jason V. Terk, MD, a Texas pediatrician and a spokesman for the American Academy of Pediatrics, told the New York Times. He said misinformation “fed the fire of distrust and skepticism that is really sort of the new pandemic of hesitancy for routine vaccines.”
The authors of the CDC report wrote: “As schools continue to return to in-person learning, enforcement of vaccination policies and follow-up with undervaccinated students are important to improve vaccination coverage.”
They urged schools and immunization programs to reach out to first-time students, including kindergartners and first-graders, and follow up with undervaccinated students.
The rate of people having an exemption from at least one vaccine remained low at 2.2% and the percentage of children with exemptions decreased in 37 states. However, an additional 3.9% who did not have a vaccine exemption were not up to date for MMR, according to the report.
Mississippi and New York had the smallest percentage of exemptions (0.1%) and Idaho had the most (8.2%). In the 2019-2020 school year, 2.5% reported an exemption from at least one vaccine. Nationally, 0.2% of kindergartners had a medical exemption and 1.9% had a nonmedical exemption.
Vaccination rates also differed among states. The New York Times noted that Maryland had a 10% drop in MMR vaccine coverage, while Wisconsin, Georgia, Wyoming, and Kentucky had declines of about 5%.
Among states reporting the measures in 2020-2021, the proportion of kindergartners attending school with no documentation of required vaccinations or exemptions ranged from 0.1% (Pennsylvania and Virginia) to 8.3% (Maryland). The state with the lowest proportion of kindergarteners out of compliance was Florida (0.2%) and Indiana had the highest out-of-compliance rate at 16.6%.
Comparing states’ performance is difficult, the authors noted, because they vary as to which vaccine and number of doses they require and by what date and what documentation they require. They also vary by data collection methods; exemptions allowed; grace period rules and provisional enrollment.
The authors, Dr. Peacock, and Dr. Terk reported no relevant financial disclosures.
FROM THE MMWR
Prenatal DNA tests lead to false alarms, FDA warns
Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.
These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.
The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.
The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.
The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.
“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”
The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”
Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.
The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.
“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”
A version of this article first appeared on WebMD.com.
Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.
These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.
The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.
The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.
The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.
“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”
The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”
Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.
The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.
“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”
A version of this article first appeared on WebMD.com.
Expectant parents and their health care providers should not entirely rely on the results of prenatal blood tests that claim to predict the chances a newborn will have a rare and potentially serious disease, the Food and Drug Administration said in a new warning.
These tests – called noninvasive prenatal screening tests – use a blood sample from a pregnant mother to look for signs that her fetus has a genetic abnormality. They tell parents the risk that a fetus has a particular genetic abnormality, but they may be wrong, the FDA said.
The FDA said expectant parents should discuss the pros and cons of genetic screening with a genetic counselor before getting the tests and seek a follow-up diagnostic test if the screening result is concerning.
The diagnostic tests that confirm or rule out a genetic abnormality, such as an amniocentesis, are more invasive than the blood draws used for genetic screening and have a small risk of miscarriage. But the diagnostic tests are more accurate, the FDA said.
The agency said some people have made critical decisions about a pregnancy, including termination, after receiving worrisome results from genetic screening tests, none of which have received FDA approval.
“Without confirming the results with a diagnostic test, there is no way to know whether the fetus actually had the genetic abnormality reported by the screening test,” the agency said in an April 19 statement. “The FDA is aware of cases where a screening test reported a genetic abnormality and a confirmatory diagnostic test later found that the fetus was healthy.”
The FDA’s notice comes several months after the New York Times reported that 85% of positive screening test results for some conditions are incorrect, despite marketing from screening companies about how their tests are “reliable” and bring “peace of mind.”
Prenatal genetic screening tests look for abnormalities that would cause a disorder, such as missing chromosomes or pieces of chromosomes, or extra chromosomes. But while these tests are often accurate for more common conditions like Down syndrome, they are much less reliable for rare diseases, the New York Times report said.
The story highlights multiple women who got diagnostic tests that disproved the scary results of their genetic screening, including the experience of Cloey Canida, a 25-year-old California woman whose genetic screening said with 99% certainty that her baby would have a disease called Patau syndrome. The test is almost always wrong for women of Ms. Canida’s age, her doctor assured her. After more than $1,000 worth of tests, Ms. Canida learned that her pregnancy was indeed healthy.
“I wish that we would have been informed of the false positive rate before I agreed to the test,” she told the Times. “I was given zero information about that.”
A version of this article first appeared on WebMD.com.
Long-term efficacy, safety data for ixekizumab in pediatric psoriasis reported
with the interleukin (IL)-17 inhibitor, investigators reported.
In addition, findings of a substudy, which evaluated randomized withdrawal of treatment after 60 weeks, suggest patients were able to regain benefit after not being treated for a period.
Ixekizumab (Taltz) was approved by the U.S. Food and Drug Administration for treating pediatric psoriasis in March 2020 for patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The trial (IXORA-PEDS) involved 171 patients aged 6-17 years (mean age, 13.5 years; 99 females and 72 males), who were randomly assigned to receive ixekizumab via subcutaneous administration every 4 weeks (115) or placebo for 12 weeks (56). Thereafter, 166 patients continued in an open-label maintenance period in which they were treated every 4 weeks for 12-60 weeks. This was followed by an extension period of up to 108 weeks, which was completed by 139 patients (83.7%). At baseline, the patients’ Psoriasis Area and Severity Index (PASI) score was 12 or higher, the static Physician’s Global Assessment (sPGA) score was 3 or higher, and 10% or more of body surface area was affected.
In the study, at 12 weeks, treatment with ixekizumab was superior to placebo, with sustained responses through 48 weeks. In the follow-up phase, primary and secondary endpoints were sustained through week 108, with patients achieving or maintaining PASI 75 (91.7%), PASI 90 (79%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Significant improvements in itch were seen at 12 weeks and were sustained with “meaningful improvements in itch for 78.5% of these patients at week 108,” the investigators report.
Among the patients who received ixekizumab, clearance rates in areas that are difficult to treat increased from week 12 to week 108 among those affected. During this time, clearance of nail psoriasis increased from 22.8% to 68.1%, clearance of palmoplantar psoriasis increased from 46.2% to 90%, clearance of scalp psoriasis increased from 70.7% to 76.2%, and clearance of genital psoriasis increased from 83.3% to 87.5%.
No new safety findings during weeks 48-108 of the trial were reported, including no new cases of inflammatory bowel disease (IBD) or Candida infections. The results were reported in JAMA Dermatology.
“Safety is really what we think of most when we are talking about pediatric patients, especially since they may be on these for decades and ... since they most commonly start these therapies in adolescence,” said Amy Paller, MD, the study’s lead author, in an interview. “To be able to take this out 108 weeks, 2 years, is starting to get to a point where we are getting more comfortable with safety. Clearly, no new signals arose.” Dr. Paller is chair of the department of dermatology and professor of dermatology and pediatrics, Northwestern University, Chicago.
One of the biggest concerns with using IL-17 inhibitors such as ixekizumab to manage psoriasis is the development of IBD, said Dr. Paller. She noted that four cases of IBD were reported before the extension phase of the trial but that no new IBD cases were reported after week 48.
“We would not start this as a treatment of choice in someone with Crohn’s disease, or perhaps we would think twice about using it in someone with a strong family history [of Crohn’s disease],” said Dr. Paller, who is also the director of the Skin Biology and Diseases Resource-Based Center at Northwestern. “Otherwise, it does not make me concerned about its use.”
Commenting on the study, Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco, said that the trial’s results provide additional evidence regarding the optimal management of pediatric psoriasis.
“The landscape has shifted toward involving more pediatric patients in clinical trials, thereby providing dermatologists with data to select safe and effective therapies to manage children with psoriasis,” Dr. Cordoro said in an interview. “We have data showing that children with psoriasis have been undertreated, likely because of concerns about safety. The more evidence available from trials such as this, the more likely children are to receive necessary treatment.”
The efficacy data from the study on difficult-to-treat areas of psoriasis, in addition to improvements in BSA and PASI measures, are significant for clinicians deciding on a therapy for patients with psoriasis concentrated in specific body sites. “It was very valuable that the efficacy data was provided by site, such as scalp, palmoplantar, nails, and genital psoriasis, as these are low-BSA but high-impact areas for patients,” said Dr. Cordoro.
The trial data on Crohn’s disease buttress her decision to continue to refrain from initiating ixekizumab in a child with IBD or who is at high risk for IBD. “I was happy to see that there was not a signal for Candida infection,” she added.
Interestingly, in the substudy in the European population, in which there was a double-blind, randomized withdrawal period, fewer patients who were reassigned to receive ixekizumab experienced relapse, compared with those who were reassigned to receive placebo. A total of 90.9% of patients who received placebo experienced relapse, compared with 17.6% of patients treated with ixekizumab. The median time to relapse in the placebo group was 149 days.
“There are data in the adult population that suggest intermittent treatment does allow for recapture of clinical response,” said Dr. Cordoro. “While it is not a large enough dataset to know definitively, this substudy of patients suggests the possibility of intermittent treatment and the ability to regain control [of psoriasis] after a period off drug.”
The study was funded by Eli Lilly. Dr. Paller is an investigator and consultant for Eli Lilly. Several other authors have received grants, personal fees, and/or were a consultant to Eli Lilly, and two authors are Eli Lilly employees. Dr. Cordoro reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
with the interleukin (IL)-17 inhibitor, investigators reported.
In addition, findings of a substudy, which evaluated randomized withdrawal of treatment after 60 weeks, suggest patients were able to regain benefit after not being treated for a period.
Ixekizumab (Taltz) was approved by the U.S. Food and Drug Administration for treating pediatric psoriasis in March 2020 for patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The trial (IXORA-PEDS) involved 171 patients aged 6-17 years (mean age, 13.5 years; 99 females and 72 males), who were randomly assigned to receive ixekizumab via subcutaneous administration every 4 weeks (115) or placebo for 12 weeks (56). Thereafter, 166 patients continued in an open-label maintenance period in which they were treated every 4 weeks for 12-60 weeks. This was followed by an extension period of up to 108 weeks, which was completed by 139 patients (83.7%). At baseline, the patients’ Psoriasis Area and Severity Index (PASI) score was 12 or higher, the static Physician’s Global Assessment (sPGA) score was 3 or higher, and 10% or more of body surface area was affected.
In the study, at 12 weeks, treatment with ixekizumab was superior to placebo, with sustained responses through 48 weeks. In the follow-up phase, primary and secondary endpoints were sustained through week 108, with patients achieving or maintaining PASI 75 (91.7%), PASI 90 (79%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Significant improvements in itch were seen at 12 weeks and were sustained with “meaningful improvements in itch for 78.5% of these patients at week 108,” the investigators report.
Among the patients who received ixekizumab, clearance rates in areas that are difficult to treat increased from week 12 to week 108 among those affected. During this time, clearance of nail psoriasis increased from 22.8% to 68.1%, clearance of palmoplantar psoriasis increased from 46.2% to 90%, clearance of scalp psoriasis increased from 70.7% to 76.2%, and clearance of genital psoriasis increased from 83.3% to 87.5%.
No new safety findings during weeks 48-108 of the trial were reported, including no new cases of inflammatory bowel disease (IBD) or Candida infections. The results were reported in JAMA Dermatology.
“Safety is really what we think of most when we are talking about pediatric patients, especially since they may be on these for decades and ... since they most commonly start these therapies in adolescence,” said Amy Paller, MD, the study’s lead author, in an interview. “To be able to take this out 108 weeks, 2 years, is starting to get to a point where we are getting more comfortable with safety. Clearly, no new signals arose.” Dr. Paller is chair of the department of dermatology and professor of dermatology and pediatrics, Northwestern University, Chicago.
One of the biggest concerns with using IL-17 inhibitors such as ixekizumab to manage psoriasis is the development of IBD, said Dr. Paller. She noted that four cases of IBD were reported before the extension phase of the trial but that no new IBD cases were reported after week 48.
“We would not start this as a treatment of choice in someone with Crohn’s disease, or perhaps we would think twice about using it in someone with a strong family history [of Crohn’s disease],” said Dr. Paller, who is also the director of the Skin Biology and Diseases Resource-Based Center at Northwestern. “Otherwise, it does not make me concerned about its use.”
Commenting on the study, Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco, said that the trial’s results provide additional evidence regarding the optimal management of pediatric psoriasis.
“The landscape has shifted toward involving more pediatric patients in clinical trials, thereby providing dermatologists with data to select safe and effective therapies to manage children with psoriasis,” Dr. Cordoro said in an interview. “We have data showing that children with psoriasis have been undertreated, likely because of concerns about safety. The more evidence available from trials such as this, the more likely children are to receive necessary treatment.”
The efficacy data from the study on difficult-to-treat areas of psoriasis, in addition to improvements in BSA and PASI measures, are significant for clinicians deciding on a therapy for patients with psoriasis concentrated in specific body sites. “It was very valuable that the efficacy data was provided by site, such as scalp, palmoplantar, nails, and genital psoriasis, as these are low-BSA but high-impact areas for patients,” said Dr. Cordoro.
The trial data on Crohn’s disease buttress her decision to continue to refrain from initiating ixekizumab in a child with IBD or who is at high risk for IBD. “I was happy to see that there was not a signal for Candida infection,” she added.
Interestingly, in the substudy in the European population, in which there was a double-blind, randomized withdrawal period, fewer patients who were reassigned to receive ixekizumab experienced relapse, compared with those who were reassigned to receive placebo. A total of 90.9% of patients who received placebo experienced relapse, compared with 17.6% of patients treated with ixekizumab. The median time to relapse in the placebo group was 149 days.
“There are data in the adult population that suggest intermittent treatment does allow for recapture of clinical response,” said Dr. Cordoro. “While it is not a large enough dataset to know definitively, this substudy of patients suggests the possibility of intermittent treatment and the ability to regain control [of psoriasis] after a period off drug.”
The study was funded by Eli Lilly. Dr. Paller is an investigator and consultant for Eli Lilly. Several other authors have received grants, personal fees, and/or were a consultant to Eli Lilly, and two authors are Eli Lilly employees. Dr. Cordoro reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
with the interleukin (IL)-17 inhibitor, investigators reported.
In addition, findings of a substudy, which evaluated randomized withdrawal of treatment after 60 weeks, suggest patients were able to regain benefit after not being treated for a period.
Ixekizumab (Taltz) was approved by the U.S. Food and Drug Administration for treating pediatric psoriasis in March 2020 for patients aged 6 years and older with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
The trial (IXORA-PEDS) involved 171 patients aged 6-17 years (mean age, 13.5 years; 99 females and 72 males), who were randomly assigned to receive ixekizumab via subcutaneous administration every 4 weeks (115) or placebo for 12 weeks (56). Thereafter, 166 patients continued in an open-label maintenance period in which they were treated every 4 weeks for 12-60 weeks. This was followed by an extension period of up to 108 weeks, which was completed by 139 patients (83.7%). At baseline, the patients’ Psoriasis Area and Severity Index (PASI) score was 12 or higher, the static Physician’s Global Assessment (sPGA) score was 3 or higher, and 10% or more of body surface area was affected.
In the study, at 12 weeks, treatment with ixekizumab was superior to placebo, with sustained responses through 48 weeks. In the follow-up phase, primary and secondary endpoints were sustained through week 108, with patients achieving or maintaining PASI 75 (91.7%), PASI 90 (79%), PASI 100 (55.1%), sPGA 0 or 1 (78.3%), and sPGA 0 (52.4%). Significant improvements in itch were seen at 12 weeks and were sustained with “meaningful improvements in itch for 78.5% of these patients at week 108,” the investigators report.
Among the patients who received ixekizumab, clearance rates in areas that are difficult to treat increased from week 12 to week 108 among those affected. During this time, clearance of nail psoriasis increased from 22.8% to 68.1%, clearance of palmoplantar psoriasis increased from 46.2% to 90%, clearance of scalp psoriasis increased from 70.7% to 76.2%, and clearance of genital psoriasis increased from 83.3% to 87.5%.
No new safety findings during weeks 48-108 of the trial were reported, including no new cases of inflammatory bowel disease (IBD) or Candida infections. The results were reported in JAMA Dermatology.
“Safety is really what we think of most when we are talking about pediatric patients, especially since they may be on these for decades and ... since they most commonly start these therapies in adolescence,” said Amy Paller, MD, the study’s lead author, in an interview. “To be able to take this out 108 weeks, 2 years, is starting to get to a point where we are getting more comfortable with safety. Clearly, no new signals arose.” Dr. Paller is chair of the department of dermatology and professor of dermatology and pediatrics, Northwestern University, Chicago.
One of the biggest concerns with using IL-17 inhibitors such as ixekizumab to manage psoriasis is the development of IBD, said Dr. Paller. She noted that four cases of IBD were reported before the extension phase of the trial but that no new IBD cases were reported after week 48.
“We would not start this as a treatment of choice in someone with Crohn’s disease, or perhaps we would think twice about using it in someone with a strong family history [of Crohn’s disease],” said Dr. Paller, who is also the director of the Skin Biology and Diseases Resource-Based Center at Northwestern. “Otherwise, it does not make me concerned about its use.”
Commenting on the study, Kelly M. Cordoro, MD, professor of dermatology and pediatrics at the University of California, San Francisco, said that the trial’s results provide additional evidence regarding the optimal management of pediatric psoriasis.
“The landscape has shifted toward involving more pediatric patients in clinical trials, thereby providing dermatologists with data to select safe and effective therapies to manage children with psoriasis,” Dr. Cordoro said in an interview. “We have data showing that children with psoriasis have been undertreated, likely because of concerns about safety. The more evidence available from trials such as this, the more likely children are to receive necessary treatment.”
The efficacy data from the study on difficult-to-treat areas of psoriasis, in addition to improvements in BSA and PASI measures, are significant for clinicians deciding on a therapy for patients with psoriasis concentrated in specific body sites. “It was very valuable that the efficacy data was provided by site, such as scalp, palmoplantar, nails, and genital psoriasis, as these are low-BSA but high-impact areas for patients,” said Dr. Cordoro.
The trial data on Crohn’s disease buttress her decision to continue to refrain from initiating ixekizumab in a child with IBD or who is at high risk for IBD. “I was happy to see that there was not a signal for Candida infection,” she added.
Interestingly, in the substudy in the European population, in which there was a double-blind, randomized withdrawal period, fewer patients who were reassigned to receive ixekizumab experienced relapse, compared with those who were reassigned to receive placebo. A total of 90.9% of patients who received placebo experienced relapse, compared with 17.6% of patients treated with ixekizumab. The median time to relapse in the placebo group was 149 days.
“There are data in the adult population that suggest intermittent treatment does allow for recapture of clinical response,” said Dr. Cordoro. “While it is not a large enough dataset to know definitively, this substudy of patients suggests the possibility of intermittent treatment and the ability to regain control [of psoriasis] after a period off drug.”
The study was funded by Eli Lilly. Dr. Paller is an investigator and consultant for Eli Lilly. Several other authors have received grants, personal fees, and/or were a consultant to Eli Lilly, and two authors are Eli Lilly employees. Dr. Cordoro reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Pandemic prompts spike in eating disorder hospitalization for adolescents
Hospital admission for children with eating disorders approximately tripled during the COVID-19 pandemic, based on data from 85 patients.
Eating disorders are common among adolescents and often require hospital admission for nutritional restoration, according to May Shum of Yale University, New Haven, Conn., and colleagues
During the COVID-19 pandemic, the volume of hospital admissions for adolescents with eating disorders has increased, the researchers wrote in a poster presented at the annual meeting of the Pediatric Academic Societies. This increase may be driven both by interruptions in medical care and increased psychological distress, but data on changes in patient characteristics and hospitalization course are lacking, they said.
The researchers reviewed charts from patients with eating disorders admitted to a single center between Jan. 1, 2017, and June 30, 2021. The majority of the patients were female (90.6%), and White (78.8%), had restrictive eating behaviors (97.2%), and had private insurance (80.0%).
Overall, the number of monthly admissions increased from 1.4 before the onset of the pandemic to 3.6 during the pandemic (P < .001).
Length of stay increased significantly from before to during pandemic cases (12.8 days vs. 17.3 days, P = .04) and age younger than 13 years was significantly associated with a longer length of stay (P < .001).
The number of patients for whom psychotropic medications were initiated or changed increased significantly (12.5% vs. 28.3%, P = .04); as did the proportion of patients discharged to partial hospitalization, residential, or inpatient psychiatric treatment rather than discharged home with outpatient therapy (56.2% vs. 75.0%, P = .04).
No significant differences were noted in demographics, comorbidities, admission parameters, EKG abnormalities, electrolyte repletion, or tube feeding.
The study findings were limited by the use of data from a single center. However, the results suggest an increase in severity of hospital admissions that have implications for use of hospital resources, the researchers said.
“In addition to an increase in hospital admissions for eating disorder management during the pandemic, longer inpatient stays of younger children with higher acuity at discharge is an added strain on hospital resources and warrants attention,” they concluded.
Considerations for younger patients
The current study is especially important at this time, Margaret Thew, DNP, FNP-BC, medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, said in an interview. “There have been reports of the rising numbers in eating disorders, but until research has been conducted, we cannot quantify the volumes,” said Ms. Thew, who was not involved in the study. “There have been many reports of the rise in mental health issues during the pandemic, so it seems accurate that the rate of eating disorders would rise,” she said. “Additionally, from a clinical perspective there seemed to be many younger-age patients with eating disorders presenting to the inpatient units who seemed sicker,” she noted.
Ms. Thew said she was not surprised by the study findings. “Working with adolescents with eating disorders we saw the increased numbers of both hospitalizations and outpatient referrals during the pandemic,” said Ms. Thew. “Length of stay was higher across the nation regarding admissions for concerns of eating disorders. These patients are sicker and fewer went home after medical stabilization,” she emphasized.
“Clinicians should be more aware of the rise in patients presenting with eating disorders at younger ages to their clinics and provide early interventions to prevent severe illness and medical instability,” said Ms. Thew. Clinicians also should be more proactive in managing younger children and adolescents who express mood disorders, disordered eating, or weight loss, given the significant rise in eating disorders and mental health concerns, she said.
Additional research is needed to continue following the rate of eating disorders into 2022, said Ms. Thew. More research is needed on early interventions and recognition of eating disorders for preteens and teens to prevent severe illness, as is research on how the younger patient with an eating disorder may present differently to the primary care doctor or emergency department, she said.
“We may need to study treatment of the younger population, as they may not do as well with admissions into behavioral health facilities,” Ms. Thew added.
The study received no outside funding. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Hospital admission for children with eating disorders approximately tripled during the COVID-19 pandemic, based on data from 85 patients.
Eating disorders are common among adolescents and often require hospital admission for nutritional restoration, according to May Shum of Yale University, New Haven, Conn., and colleagues
During the COVID-19 pandemic, the volume of hospital admissions for adolescents with eating disorders has increased, the researchers wrote in a poster presented at the annual meeting of the Pediatric Academic Societies. This increase may be driven both by interruptions in medical care and increased psychological distress, but data on changes in patient characteristics and hospitalization course are lacking, they said.
The researchers reviewed charts from patients with eating disorders admitted to a single center between Jan. 1, 2017, and June 30, 2021. The majority of the patients were female (90.6%), and White (78.8%), had restrictive eating behaviors (97.2%), and had private insurance (80.0%).
Overall, the number of monthly admissions increased from 1.4 before the onset of the pandemic to 3.6 during the pandemic (P < .001).
Length of stay increased significantly from before to during pandemic cases (12.8 days vs. 17.3 days, P = .04) and age younger than 13 years was significantly associated with a longer length of stay (P < .001).
The number of patients for whom psychotropic medications were initiated or changed increased significantly (12.5% vs. 28.3%, P = .04); as did the proportion of patients discharged to partial hospitalization, residential, or inpatient psychiatric treatment rather than discharged home with outpatient therapy (56.2% vs. 75.0%, P = .04).
No significant differences were noted in demographics, comorbidities, admission parameters, EKG abnormalities, electrolyte repletion, or tube feeding.
The study findings were limited by the use of data from a single center. However, the results suggest an increase in severity of hospital admissions that have implications for use of hospital resources, the researchers said.
“In addition to an increase in hospital admissions for eating disorder management during the pandemic, longer inpatient stays of younger children with higher acuity at discharge is an added strain on hospital resources and warrants attention,” they concluded.
Considerations for younger patients
The current study is especially important at this time, Margaret Thew, DNP, FNP-BC, medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, said in an interview. “There have been reports of the rising numbers in eating disorders, but until research has been conducted, we cannot quantify the volumes,” said Ms. Thew, who was not involved in the study. “There have been many reports of the rise in mental health issues during the pandemic, so it seems accurate that the rate of eating disorders would rise,” she said. “Additionally, from a clinical perspective there seemed to be many younger-age patients with eating disorders presenting to the inpatient units who seemed sicker,” she noted.
Ms. Thew said she was not surprised by the study findings. “Working with adolescents with eating disorders we saw the increased numbers of both hospitalizations and outpatient referrals during the pandemic,” said Ms. Thew. “Length of stay was higher across the nation regarding admissions for concerns of eating disorders. These patients are sicker and fewer went home after medical stabilization,” she emphasized.
“Clinicians should be more aware of the rise in patients presenting with eating disorders at younger ages to their clinics and provide early interventions to prevent severe illness and medical instability,” said Ms. Thew. Clinicians also should be more proactive in managing younger children and adolescents who express mood disorders, disordered eating, or weight loss, given the significant rise in eating disorders and mental health concerns, she said.
Additional research is needed to continue following the rate of eating disorders into 2022, said Ms. Thew. More research is needed on early interventions and recognition of eating disorders for preteens and teens to prevent severe illness, as is research on how the younger patient with an eating disorder may present differently to the primary care doctor or emergency department, she said.
“We may need to study treatment of the younger population, as they may not do as well with admissions into behavioral health facilities,” Ms. Thew added.
The study received no outside funding. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
Hospital admission for children with eating disorders approximately tripled during the COVID-19 pandemic, based on data from 85 patients.
Eating disorders are common among adolescents and often require hospital admission for nutritional restoration, according to May Shum of Yale University, New Haven, Conn., and colleagues
During the COVID-19 pandemic, the volume of hospital admissions for adolescents with eating disorders has increased, the researchers wrote in a poster presented at the annual meeting of the Pediatric Academic Societies. This increase may be driven both by interruptions in medical care and increased psychological distress, but data on changes in patient characteristics and hospitalization course are lacking, they said.
The researchers reviewed charts from patients with eating disorders admitted to a single center between Jan. 1, 2017, and June 30, 2021. The majority of the patients were female (90.6%), and White (78.8%), had restrictive eating behaviors (97.2%), and had private insurance (80.0%).
Overall, the number of monthly admissions increased from 1.4 before the onset of the pandemic to 3.6 during the pandemic (P < .001).
Length of stay increased significantly from before to during pandemic cases (12.8 days vs. 17.3 days, P = .04) and age younger than 13 years was significantly associated with a longer length of stay (P < .001).
The number of patients for whom psychotropic medications were initiated or changed increased significantly (12.5% vs. 28.3%, P = .04); as did the proportion of patients discharged to partial hospitalization, residential, or inpatient psychiatric treatment rather than discharged home with outpatient therapy (56.2% vs. 75.0%, P = .04).
No significant differences were noted in demographics, comorbidities, admission parameters, EKG abnormalities, electrolyte repletion, or tube feeding.
The study findings were limited by the use of data from a single center. However, the results suggest an increase in severity of hospital admissions that have implications for use of hospital resources, the researchers said.
“In addition to an increase in hospital admissions for eating disorder management during the pandemic, longer inpatient stays of younger children with higher acuity at discharge is an added strain on hospital resources and warrants attention,” they concluded.
Considerations for younger patients
The current study is especially important at this time, Margaret Thew, DNP, FNP-BC, medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee, said in an interview. “There have been reports of the rising numbers in eating disorders, but until research has been conducted, we cannot quantify the volumes,” said Ms. Thew, who was not involved in the study. “There have been many reports of the rise in mental health issues during the pandemic, so it seems accurate that the rate of eating disorders would rise,” she said. “Additionally, from a clinical perspective there seemed to be many younger-age patients with eating disorders presenting to the inpatient units who seemed sicker,” she noted.
Ms. Thew said she was not surprised by the study findings. “Working with adolescents with eating disorders we saw the increased numbers of both hospitalizations and outpatient referrals during the pandemic,” said Ms. Thew. “Length of stay was higher across the nation regarding admissions for concerns of eating disorders. These patients are sicker and fewer went home after medical stabilization,” she emphasized.
“Clinicians should be more aware of the rise in patients presenting with eating disorders at younger ages to their clinics and provide early interventions to prevent severe illness and medical instability,” said Ms. Thew. Clinicians also should be more proactive in managing younger children and adolescents who express mood disorders, disordered eating, or weight loss, given the significant rise in eating disorders and mental health concerns, she said.
Additional research is needed to continue following the rate of eating disorders into 2022, said Ms. Thew. More research is needed on early interventions and recognition of eating disorders for preteens and teens to prevent severe illness, as is research on how the younger patient with an eating disorder may present differently to the primary care doctor or emergency department, she said.
“We may need to study treatment of the younger population, as they may not do as well with admissions into behavioral health facilities,” Ms. Thew added.
The study received no outside funding. The researchers had no financial conflicts to disclose. Ms. Thew had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
FROM PAS 2022
Water, water everywhere leads to leaner students
Elementary schools that provide easy access to drinking water and education about its benefits may help their students maintain a healthy weight, a new study found.
Researchers examined the health and drinking habits of 1,249 children in 26 low-income, ethnically diverse elementary schools in the San Francisco Bay Area. In half of the schools, water stations were placed throughout, along with signs explaining why water is healthier than sugary drinks. In addition, assemblies were held explaining the advantages of water over sugary drinks.
That simple message seemed to have had an outsized effect. Schools with water stations had significantly fewer overweight students than the other schools by the end of the 15-month study, according to Anisha Patel, MD, MSPH, MSHS, associate professor of pediatrics at Stanford (Calif.) University, who will be presenting the findings at the Pediatric Academic Societies (PAS) 2022 Meeting, Denver.
“Sugar-sweetened beverages are a huge contributor to obesity,” Dr. Patel told this news organization. “This provides a key strategy for schools to adopt, and the time is right for this type of work – in the pandemic period we’ve seen significant increases in obesity. Investments like this could help stem that.”
According to the U.S. Centers for Disease Control and Prevention, 14.4 million children aged 2-19 years in the United States – about 19% of all kids in that age range – were obese in 2017-2018. The agency said the rate of increase in body mass index among this group nearly doubled during the COVID-19 pandemic.
Children with obesity are at higher risk for chronic health problems, including diabetes, heart disease, depression, and high blood pressure.
Dr. Patel’s study, funded by the National Institutes of Health, was the culmination of a decade of interest in the area, she said.
Water stations and compostable or recyclable cups were placed in high-traffic areas of the schools, including playgrounds and cafeterias. The water was tested for lead, and if needed, researchers worked with school districts to remediate, Dr. Patel said in an interview.
The intervention included a kickoff assembly about the health benefits of water intake, and students who were seen drinking water with their lunches were given small prizes.
The researchers assessed body weight, height, and dietary intake of students throughout the study, including their consumption of water, sodas, fruit juices, and flavored and unflavored milk.
Promoting water didn’t lead to magical weight loss. At the start of the study, 49.5% of students in the intervention group were overweight – a figure that nudged up to 49.8% by the end of the study. In the control group, however, 47.7% of students began the study overweight – a number that climbed to 51.4% by the end of the trial (odds ratio, 0.3; P = .01), according to the researchers, who credited the increase to the lack of emphasis on opting for water over sweetened drinks.
“We were very excited the effect sizes were nearly double previous studies, which was great news,” Dr. Patel said.
Water intake began to decline at about the 15-month mark, signaling the need for more long-term, consistent education and incentive to foster lasting habits, Dr. Patel said.
The researchers noted that they were unable to collect data from eight of the target schools because of the pandemic. In addition, the study focused on schools with heavily Latino student populations, so the results might not be generalizable to other communities, they said.
Angie Cradock, a principal research scientist at the Harvard T. H. Chan School of Public Health, Boston, said the study “offers an important and practical strategy to promote student health.”
Ms. Cradock serves as deputy director of the Harvard Prevention Research Center on Nutrition and Physical Activity, which focuses on improving population nutrition, increasing physical activity, reducing obesity and chronic disease, and improving health equity.
Dr. Patel and her colleagues’ three-pronged approach of using education, promotion, and accessibility to increase student interest in drinking water could be employed at countless other schools, said Ms. Cradock, who was not involved in the study.
“Negative perceptions of tap water and drinking fountains are common,” she said. “Not all students have access to safe and appealing drinking water while at school, and this strategy seems like a recipe for success.”
Dr. Patel reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Elementary schools that provide easy access to drinking water and education about its benefits may help their students maintain a healthy weight, a new study found.
Researchers examined the health and drinking habits of 1,249 children in 26 low-income, ethnically diverse elementary schools in the San Francisco Bay Area. In half of the schools, water stations were placed throughout, along with signs explaining why water is healthier than sugary drinks. In addition, assemblies were held explaining the advantages of water over sugary drinks.
That simple message seemed to have had an outsized effect. Schools with water stations had significantly fewer overweight students than the other schools by the end of the 15-month study, according to Anisha Patel, MD, MSPH, MSHS, associate professor of pediatrics at Stanford (Calif.) University, who will be presenting the findings at the Pediatric Academic Societies (PAS) 2022 Meeting, Denver.
“Sugar-sweetened beverages are a huge contributor to obesity,” Dr. Patel told this news organization. “This provides a key strategy for schools to adopt, and the time is right for this type of work – in the pandemic period we’ve seen significant increases in obesity. Investments like this could help stem that.”
According to the U.S. Centers for Disease Control and Prevention, 14.4 million children aged 2-19 years in the United States – about 19% of all kids in that age range – were obese in 2017-2018. The agency said the rate of increase in body mass index among this group nearly doubled during the COVID-19 pandemic.
Children with obesity are at higher risk for chronic health problems, including diabetes, heart disease, depression, and high blood pressure.
Dr. Patel’s study, funded by the National Institutes of Health, was the culmination of a decade of interest in the area, she said.
Water stations and compostable or recyclable cups were placed in high-traffic areas of the schools, including playgrounds and cafeterias. The water was tested for lead, and if needed, researchers worked with school districts to remediate, Dr. Patel said in an interview.
The intervention included a kickoff assembly about the health benefits of water intake, and students who were seen drinking water with their lunches were given small prizes.
The researchers assessed body weight, height, and dietary intake of students throughout the study, including their consumption of water, sodas, fruit juices, and flavored and unflavored milk.
Promoting water didn’t lead to magical weight loss. At the start of the study, 49.5% of students in the intervention group were overweight – a figure that nudged up to 49.8% by the end of the study. In the control group, however, 47.7% of students began the study overweight – a number that climbed to 51.4% by the end of the trial (odds ratio, 0.3; P = .01), according to the researchers, who credited the increase to the lack of emphasis on opting for water over sweetened drinks.
“We were very excited the effect sizes were nearly double previous studies, which was great news,” Dr. Patel said.
Water intake began to decline at about the 15-month mark, signaling the need for more long-term, consistent education and incentive to foster lasting habits, Dr. Patel said.
The researchers noted that they were unable to collect data from eight of the target schools because of the pandemic. In addition, the study focused on schools with heavily Latino student populations, so the results might not be generalizable to other communities, they said.
Angie Cradock, a principal research scientist at the Harvard T. H. Chan School of Public Health, Boston, said the study “offers an important and practical strategy to promote student health.”
Ms. Cradock serves as deputy director of the Harvard Prevention Research Center on Nutrition and Physical Activity, which focuses on improving population nutrition, increasing physical activity, reducing obesity and chronic disease, and improving health equity.
Dr. Patel and her colleagues’ three-pronged approach of using education, promotion, and accessibility to increase student interest in drinking water could be employed at countless other schools, said Ms. Cradock, who was not involved in the study.
“Negative perceptions of tap water and drinking fountains are common,” she said. “Not all students have access to safe and appealing drinking water while at school, and this strategy seems like a recipe for success.”
Dr. Patel reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Elementary schools that provide easy access to drinking water and education about its benefits may help their students maintain a healthy weight, a new study found.
Researchers examined the health and drinking habits of 1,249 children in 26 low-income, ethnically diverse elementary schools in the San Francisco Bay Area. In half of the schools, water stations were placed throughout, along with signs explaining why water is healthier than sugary drinks. In addition, assemblies were held explaining the advantages of water over sugary drinks.
That simple message seemed to have had an outsized effect. Schools with water stations had significantly fewer overweight students than the other schools by the end of the 15-month study, according to Anisha Patel, MD, MSPH, MSHS, associate professor of pediatrics at Stanford (Calif.) University, who will be presenting the findings at the Pediatric Academic Societies (PAS) 2022 Meeting, Denver.
“Sugar-sweetened beverages are a huge contributor to obesity,” Dr. Patel told this news organization. “This provides a key strategy for schools to adopt, and the time is right for this type of work – in the pandemic period we’ve seen significant increases in obesity. Investments like this could help stem that.”
According to the U.S. Centers for Disease Control and Prevention, 14.4 million children aged 2-19 years in the United States – about 19% of all kids in that age range – were obese in 2017-2018. The agency said the rate of increase in body mass index among this group nearly doubled during the COVID-19 pandemic.
Children with obesity are at higher risk for chronic health problems, including diabetes, heart disease, depression, and high blood pressure.
Dr. Patel’s study, funded by the National Institutes of Health, was the culmination of a decade of interest in the area, she said.
Water stations and compostable or recyclable cups were placed in high-traffic areas of the schools, including playgrounds and cafeterias. The water was tested for lead, and if needed, researchers worked with school districts to remediate, Dr. Patel said in an interview.
The intervention included a kickoff assembly about the health benefits of water intake, and students who were seen drinking water with their lunches were given small prizes.
The researchers assessed body weight, height, and dietary intake of students throughout the study, including their consumption of water, sodas, fruit juices, and flavored and unflavored milk.
Promoting water didn’t lead to magical weight loss. At the start of the study, 49.5% of students in the intervention group were overweight – a figure that nudged up to 49.8% by the end of the study. In the control group, however, 47.7% of students began the study overweight – a number that climbed to 51.4% by the end of the trial (odds ratio, 0.3; P = .01), according to the researchers, who credited the increase to the lack of emphasis on opting for water over sweetened drinks.
“We were very excited the effect sizes were nearly double previous studies, which was great news,” Dr. Patel said.
Water intake began to decline at about the 15-month mark, signaling the need for more long-term, consistent education and incentive to foster lasting habits, Dr. Patel said.
The researchers noted that they were unable to collect data from eight of the target schools because of the pandemic. In addition, the study focused on schools with heavily Latino student populations, so the results might not be generalizable to other communities, they said.
Angie Cradock, a principal research scientist at the Harvard T. H. Chan School of Public Health, Boston, said the study “offers an important and practical strategy to promote student health.”
Ms. Cradock serves as deputy director of the Harvard Prevention Research Center on Nutrition and Physical Activity, which focuses on improving population nutrition, increasing physical activity, reducing obesity and chronic disease, and improving health equity.
Dr. Patel and her colleagues’ three-pronged approach of using education, promotion, and accessibility to increase student interest in drinking water could be employed at countless other schools, said Ms. Cradock, who was not involved in the study.
“Negative perceptions of tap water and drinking fountains are common,” she said. “Not all students have access to safe and appealing drinking water while at school, and this strategy seems like a recipe for success.”
Dr. Patel reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Majority of pandemic pediatric visits managed with telemedicine
Approximately two-thirds of pediatric acute care concerns managed in telemedicine visits required no additional visits or follow-up, based on data from more than 600 visits.
The increase in use of telemedicine during the first year of the COVID-19 pandemic enabled access to care and connection to doctors for many pediatric patients, said Kristina Kissiova, MD, of Children’s National Health System, Washington, and colleagues. Some advantages of telemedicine include enhanced medical homes, reduced health care costs, and less crowding and wait time for patients in offices and emergency departments; however, the optimal use of telemedicine for acute primary care has not been examined, they said.
In a study presented at the annual meeting of the Pediatric Academic Societies, the researchers conducted a retrospective chart review of 638 acute care telemedicine visits conducted by 21 health care providers at a single practice in Washington in October 2020 and November 2020. Approximately half of the patients were male, 65% were white, and 89% had commercial insurance. The most common age group was 6-12 years (23%), followed by 2-3 years (16%), 3-6 years (15%), and 12-18 years (14%).
The primary outcome was the number and nature of visits completed via telemedicine without the need for referral or a subsequent in-person visit. Telemedicine visits for well-child checks and follow-up visits were excluded.
Overall, 60% of the visits (384 of 638) were completed over telemedicine with no need for additional visits or referrals. The most common acute complaints were upper respiratory infections, dermatologic issues, gastrointestinal issues, COVID-19 related issues, and fever (18.7%, 16.3%, 12.9%, 11.9%, and 10.3%, respectively).
Of these, dermatologic and GI concerns were most often completed via telemedicine (93.3% and 81.7%, respectively), while upper respiratory tract infections and fever issues were the least likely to be completed via telemedicine (22.7% and 13.6%), mainly because of the need to report for in-person COVID-19 testing, the researchers said.
Among other less common chief complaints, 100% of breathing concerns, behavior/mental health concerns, and head trauma or falls were addressed via telemedicine without additional referrals or follow-up visits. In addition, 90.9% of urgent care or emergency department follow-ups, 88.9% of ear concerns, and 87.5% of eye concerns were completely resolved via telemedicine visits.
Overall, 3% of patients who were not referred after a telemedicine visit presented in person for worsening symptoms. Of these who were referred after a telemedicine visit, 90% were seen in person within 48 hours.
The study findings were limited by the inclusion of data from only a single center. However, “These early findings provide insight into the utility of telehealth in the primary care setting for a broad array of urgent concerns,” the researchers concluded.
Pandemic propelled telemedicine to improve patient care
The widespread adoption of telemedicine in primary care has been a beneficial side effect of the COVID-19 pandemic, said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
“Toward the end of World War II and in the push to form the United Nations, Winston Churchill was credited with the saying, ‘Never let a good crisis go to waste,’” said Dr. Joos, who was not connected with the study.
“As awful as this pandemic has been, it has propelled health care delivery at an unprecedented pace into the digital age,” he noted.
The current study is important because it highlights the number of complaints that can be successfully resolved through telemedicine, offering patients and families quicker access and more options for care, Dr. Joos said.
“I feel that giving patients and families an open choice for either telemedicine or in-person visits improves the likelihood that the issue will be resolved efficiently and satisfactorily with fewer visits,” he added.
Approximately two-thirds of pediatric acute care concerns managed in telemedicine visits required no additional visits or follow-up, based on data from more than 600 visits.
The increase in use of telemedicine during the first year of the COVID-19 pandemic enabled access to care and connection to doctors for many pediatric patients, said Kristina Kissiova, MD, of Children’s National Health System, Washington, and colleagues. Some advantages of telemedicine include enhanced medical homes, reduced health care costs, and less crowding and wait time for patients in offices and emergency departments; however, the optimal use of telemedicine for acute primary care has not been examined, they said.
In a study presented at the annual meeting of the Pediatric Academic Societies, the researchers conducted a retrospective chart review of 638 acute care telemedicine visits conducted by 21 health care providers at a single practice in Washington in October 2020 and November 2020. Approximately half of the patients were male, 65% were white, and 89% had commercial insurance. The most common age group was 6-12 years (23%), followed by 2-3 years (16%), 3-6 years (15%), and 12-18 years (14%).
The primary outcome was the number and nature of visits completed via telemedicine without the need for referral or a subsequent in-person visit. Telemedicine visits for well-child checks and follow-up visits were excluded.
Overall, 60% of the visits (384 of 638) were completed over telemedicine with no need for additional visits or referrals. The most common acute complaints were upper respiratory infections, dermatologic issues, gastrointestinal issues, COVID-19 related issues, and fever (18.7%, 16.3%, 12.9%, 11.9%, and 10.3%, respectively).
Of these, dermatologic and GI concerns were most often completed via telemedicine (93.3% and 81.7%, respectively), while upper respiratory tract infections and fever issues were the least likely to be completed via telemedicine (22.7% and 13.6%), mainly because of the need to report for in-person COVID-19 testing, the researchers said.
Among other less common chief complaints, 100% of breathing concerns, behavior/mental health concerns, and head trauma or falls were addressed via telemedicine without additional referrals or follow-up visits. In addition, 90.9% of urgent care or emergency department follow-ups, 88.9% of ear concerns, and 87.5% of eye concerns were completely resolved via telemedicine visits.
Overall, 3% of patients who were not referred after a telemedicine visit presented in person for worsening symptoms. Of these who were referred after a telemedicine visit, 90% were seen in person within 48 hours.
The study findings were limited by the inclusion of data from only a single center. However, “These early findings provide insight into the utility of telehealth in the primary care setting for a broad array of urgent concerns,” the researchers concluded.
Pandemic propelled telemedicine to improve patient care
The widespread adoption of telemedicine in primary care has been a beneficial side effect of the COVID-19 pandemic, said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
“Toward the end of World War II and in the push to form the United Nations, Winston Churchill was credited with the saying, ‘Never let a good crisis go to waste,’” said Dr. Joos, who was not connected with the study.
“As awful as this pandemic has been, it has propelled health care delivery at an unprecedented pace into the digital age,” he noted.
The current study is important because it highlights the number of complaints that can be successfully resolved through telemedicine, offering patients and families quicker access and more options for care, Dr. Joos said.
“I feel that giving patients and families an open choice for either telemedicine or in-person visits improves the likelihood that the issue will be resolved efficiently and satisfactorily with fewer visits,” he added.
Approximately two-thirds of pediatric acute care concerns managed in telemedicine visits required no additional visits or follow-up, based on data from more than 600 visits.
The increase in use of telemedicine during the first year of the COVID-19 pandemic enabled access to care and connection to doctors for many pediatric patients, said Kristina Kissiova, MD, of Children’s National Health System, Washington, and colleagues. Some advantages of telemedicine include enhanced medical homes, reduced health care costs, and less crowding and wait time for patients in offices and emergency departments; however, the optimal use of telemedicine for acute primary care has not been examined, they said.
In a study presented at the annual meeting of the Pediatric Academic Societies, the researchers conducted a retrospective chart review of 638 acute care telemedicine visits conducted by 21 health care providers at a single practice in Washington in October 2020 and November 2020. Approximately half of the patients were male, 65% were white, and 89% had commercial insurance. The most common age group was 6-12 years (23%), followed by 2-3 years (16%), 3-6 years (15%), and 12-18 years (14%).
The primary outcome was the number and nature of visits completed via telemedicine without the need for referral or a subsequent in-person visit. Telemedicine visits for well-child checks and follow-up visits were excluded.
Overall, 60% of the visits (384 of 638) were completed over telemedicine with no need for additional visits or referrals. The most common acute complaints were upper respiratory infections, dermatologic issues, gastrointestinal issues, COVID-19 related issues, and fever (18.7%, 16.3%, 12.9%, 11.9%, and 10.3%, respectively).
Of these, dermatologic and GI concerns were most often completed via telemedicine (93.3% and 81.7%, respectively), while upper respiratory tract infections and fever issues were the least likely to be completed via telemedicine (22.7% and 13.6%), mainly because of the need to report for in-person COVID-19 testing, the researchers said.
Among other less common chief complaints, 100% of breathing concerns, behavior/mental health concerns, and head trauma or falls were addressed via telemedicine without additional referrals or follow-up visits. In addition, 90.9% of urgent care or emergency department follow-ups, 88.9% of ear concerns, and 87.5% of eye concerns were completely resolved via telemedicine visits.
Overall, 3% of patients who were not referred after a telemedicine visit presented in person for worsening symptoms. Of these who were referred after a telemedicine visit, 90% were seen in person within 48 hours.
The study findings were limited by the inclusion of data from only a single center. However, “These early findings provide insight into the utility of telehealth in the primary care setting for a broad array of urgent concerns,” the researchers concluded.
Pandemic propelled telemedicine to improve patient care
The widespread adoption of telemedicine in primary care has been a beneficial side effect of the COVID-19 pandemic, said Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, in an interview.
“Toward the end of World War II and in the push to form the United Nations, Winston Churchill was credited with the saying, ‘Never let a good crisis go to waste,’” said Dr. Joos, who was not connected with the study.
“As awful as this pandemic has been, it has propelled health care delivery at an unprecedented pace into the digital age,” he noted.
The current study is important because it highlights the number of complaints that can be successfully resolved through telemedicine, offering patients and families quicker access and more options for care, Dr. Joos said.
“I feel that giving patients and families an open choice for either telemedicine or in-person visits improves the likelihood that the issue will be resolved efficiently and satisfactorily with fewer visits,” he added.
FROM PAS 2022
How gender-affirming care is provided to adolescents in the United States
“Texas investigates parents of transgender teen.” “Court did not force dad to allow chemical castration of son.” Headlines such as these are becoming more common as transgender adolescents and young adults, as well as their families, continue to come under attack from state and local governments. In the 2021 state legislative sessions, more than 100 anti-trans bills were filed across 35 state legislatures. Texas alone saw 13 anti-trans bills, covering everything from sports participation to criminalization of best-practice medical care.1 Many of these bills are introduced under the guise of “protecting” these adolescents and young adults but are detrimental to their health. They also contain descriptions of gender-affirming care that do not reflect the evidence-based standards of care followed by clinicians across the country. Below is scientifically accurate information on gender-affirming care.
Gender identity development
Trajectories of gender identity are diverse. In a large sample of transgender adults (n = 27,715), 10% started to realize they were transgender at age 5 or younger, 16% between ages 6 and 10, 28% between 11 and 15, 29% between 16 and 20, and 18% at age 21 or older.2 In childhood, cross-gender play and preferences are a normal part of gender expression and many gender-nonconforming children will go on to identify with the sex they were assigned at birth (labeled cisgender). However, some children explicitly identify with a gender different than the sex they were assigned at birth (labeled transgender). Children who are consistent, insistent, and persistent in this identity appear likely to remain so into adolescence and adulthood. It is important to note that there is no evidence that discouraging gender nonconformity decreases the likelihood that a child will identify as transgender. In fact, this practice is no longer considered ethical, as it can have damaging effects on self-esteem and mental health. In addition, not all transgender people are noticeably gender nonconforming in childhood and that lack of childhood gender nonconformity does not invalidate someone’s transgender identity.
Gender-affirming care
For youth who identify as transgender, all steps in transition prior to puberty are social. This includes steps like changing hairstyles or clothing and using a different (affirmed) name and/or pronouns. This time period allows youth to explore their gender identity and expression. In one large study of 10,000 LGBTQ youth, among youth who reported “all or most people” used their affirmed pronoun, 12% reported a history of suicide attempt.3 In comparison, among those who reported that “no one” used their affirmed pronoun, the suicide attempt rate was 28%. Further, 14% of youth who reported that they were able to make changes in their clothing and appearance reported a past suicide attempt in comparison to 26% of those who were not able to. Many of these youth also are under the care of mental health professionals during this time.
At the onset of puberty, transgender youth are eligible for medical management, if needed, to address gender dysphoria (i.e., distress with one’s sex characteristics that is consistent and impairing). It is important to recognize that not all people who identify as transgender experience gender dysphoria or desire a medical transition. For those who do seek medical care, puberty must be confirmed either by breast/testicular exam or checking gonadotropin levels. Standards of care suggest that prior to pubertal suppression with GnRH agonists, such as leuprolide or histrelin, adolescents undergo a thorough psychosocial evaluation by a qualified, licensed clinician. After this evaluation, pubertal suppression may be initiated. These adolescents are monitored by their physicians every 3-6 months for side effects and continuing evaluation of their gender identity. GnRH agonists pause any further pubertal development while the adolescent continues to explore his/her/their gender identity. GnRH agonists are fully reversible and if they are stopped, the child’s natal puberty would recommence.
If an adolescent desires to start gender-affirming hormones, these are started as early as age 14, depending on their maturity, when they desire to start, and/or their ability to obtain parental consent. If a patient has not begun GnRH agonists and undergone a previous psychosocial evaluation, a thorough psychosocial evaluation by a qualified, licensed clinician would take place prior to initiating gender-affirming hormones. Prior to initiating hormones, a thorough informed-consent process occurs between the clinician, patient, and family. This process reviews reversible versus irreversible effects, as well of any side effects of the medication(s). Adolescents who begin hormonal treatment are then monitored every 3-6 months for medication side effects, efficacy, satisfaction with treatment, and by continued mental health assessments. Engagement in mental health therapy is not required beyond the initial evaluation (as many adolescents are well adjusted), but it is encouraged for support during the adolescent’s transition.4 It is important to note that the decision to begin hormones, or not, as well as how to adjust dosing over time, is nuanced and is individualized to each patient’s particular goals for his/her/their transition.
Care for transmasculine identified adolescents (those who were assigned female at birth) typically involves testosterone, delivered via subcutaneous injection, transdermal patch, or transdermal gel. Care for transfeminine individuals (those who were assigned male at birth) typically involves estradiol, delivered via daily pill, weekly or twice weekly transdermal patch, or intramuscular injection, as well as an androgen blocker. This is because estradiol by itself is a weak androgen inhibitor. Antiandrogen medication is delivered by daily oral spironolactone, daily oral bicalutamide (an androgen receptor blocker), or GnRH agonists similar to those used for puberty blockade.
Outcomes
At least 13 studies have documented an improvement in gender dysphoria and/or mental health for adolescents and young adults after beginning gender affirming medical care.5 A recent study by Turban et al. showed that access to gender affirming hormones during adolescence or early adulthood was associated with decreased odds of past month suicidal ideation than for those who did not have access to gender-affirming hormones.6 Tordoff et al. found that receipt of gender-affirming care, including medications, led to a 60% decrease in depressive symptoms and a 73% decrease in suicidality.7 One other question that often arises is whether youth who undergo medical treatment for their transition regret their transition or retransition back to the sex they were assigned at birth. In a large study at a gender clinic in the United Kingdom, they found a regret rate of only 0.47% (16 of 3,398 adolescents aged 13-20).8 This is similar to other studies that have also found low rates of regret. Regret is often due to lack of acceptance in society rather than lack of transgender identity.
The care of gender diverse youth takes place on a spectrum, including options that do not include medical treatment. By supporting youth where they are on their gender journey, there is a significant reduction in adverse mental health outcomes. Gender-affirming hormonal treatment is individualized and a thorough multidisciplinary evaluation and informed consent are obtained prior to initiation. There are careful, nuanced discussions with patients and their families to individualize care based on individual goals. By following established evidence-based standards of care, physicians can support their gender-diverse patients throughout their gender journey. Just like other medical treatments, procedures, or surgeries, gender-affirming care should be undertaken in the context of the sacred patient-physician relationship.
Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas.
References
1. Equality Texas. Legislative Bill Tracker.
2. James SE et al. The Report of the 2015 U.S. Transgender Survey. 2016. Washington, DC: National Center for Transgender Equality.
3. The Trevor Project. 2020. National Survey on LGBTQ Mental Health.
4. Lopez X et al. Curr Opin Pediatrics. 2017;29(4):475-80.
5. Turban J. The evidence for trans youth gender-affirming medical care. Psychology Today. 2022 Jan 24.
6. Turban J et al. Access to gender-affirming hormones during adolescence and mental health outcomes among transgender adults. PLOS ONE. 2022;17(1).
7. Tordoff DM et al. Mental health outcomes in transgender and nonbinary youths receiving gender-affirming care. JAMA Network Open. 2022;5(2).
8. Davies S et al. Detransition rates in a national UK gender identity clinic. Inside Matters. On Law, Ethics, and Religion. 2019 Apr 11.
“Texas investigates parents of transgender teen.” “Court did not force dad to allow chemical castration of son.” Headlines such as these are becoming more common as transgender adolescents and young adults, as well as their families, continue to come under attack from state and local governments. In the 2021 state legislative sessions, more than 100 anti-trans bills were filed across 35 state legislatures. Texas alone saw 13 anti-trans bills, covering everything from sports participation to criminalization of best-practice medical care.1 Many of these bills are introduced under the guise of “protecting” these adolescents and young adults but are detrimental to their health. They also contain descriptions of gender-affirming care that do not reflect the evidence-based standards of care followed by clinicians across the country. Below is scientifically accurate information on gender-affirming care.
Gender identity development
Trajectories of gender identity are diverse. In a large sample of transgender adults (n = 27,715), 10% started to realize they were transgender at age 5 or younger, 16% between ages 6 and 10, 28% between 11 and 15, 29% between 16 and 20, and 18% at age 21 or older.2 In childhood, cross-gender play and preferences are a normal part of gender expression and many gender-nonconforming children will go on to identify with the sex they were assigned at birth (labeled cisgender). However, some children explicitly identify with a gender different than the sex they were assigned at birth (labeled transgender). Children who are consistent, insistent, and persistent in this identity appear likely to remain so into adolescence and adulthood. It is important to note that there is no evidence that discouraging gender nonconformity decreases the likelihood that a child will identify as transgender. In fact, this practice is no longer considered ethical, as it can have damaging effects on self-esteem and mental health. In addition, not all transgender people are noticeably gender nonconforming in childhood and that lack of childhood gender nonconformity does not invalidate someone’s transgender identity.
Gender-affirming care
For youth who identify as transgender, all steps in transition prior to puberty are social. This includes steps like changing hairstyles or clothing and using a different (affirmed) name and/or pronouns. This time period allows youth to explore their gender identity and expression. In one large study of 10,000 LGBTQ youth, among youth who reported “all or most people” used their affirmed pronoun, 12% reported a history of suicide attempt.3 In comparison, among those who reported that “no one” used their affirmed pronoun, the suicide attempt rate was 28%. Further, 14% of youth who reported that they were able to make changes in their clothing and appearance reported a past suicide attempt in comparison to 26% of those who were not able to. Many of these youth also are under the care of mental health professionals during this time.
At the onset of puberty, transgender youth are eligible for medical management, if needed, to address gender dysphoria (i.e., distress with one’s sex characteristics that is consistent and impairing). It is important to recognize that not all people who identify as transgender experience gender dysphoria or desire a medical transition. For those who do seek medical care, puberty must be confirmed either by breast/testicular exam or checking gonadotropin levels. Standards of care suggest that prior to pubertal suppression with GnRH agonists, such as leuprolide or histrelin, adolescents undergo a thorough psychosocial evaluation by a qualified, licensed clinician. After this evaluation, pubertal suppression may be initiated. These adolescents are monitored by their physicians every 3-6 months for side effects and continuing evaluation of their gender identity. GnRH agonists pause any further pubertal development while the adolescent continues to explore his/her/their gender identity. GnRH agonists are fully reversible and if they are stopped, the child’s natal puberty would recommence.
If an adolescent desires to start gender-affirming hormones, these are started as early as age 14, depending on their maturity, when they desire to start, and/or their ability to obtain parental consent. If a patient has not begun GnRH agonists and undergone a previous psychosocial evaluation, a thorough psychosocial evaluation by a qualified, licensed clinician would take place prior to initiating gender-affirming hormones. Prior to initiating hormones, a thorough informed-consent process occurs between the clinician, patient, and family. This process reviews reversible versus irreversible effects, as well of any side effects of the medication(s). Adolescents who begin hormonal treatment are then monitored every 3-6 months for medication side effects, efficacy, satisfaction with treatment, and by continued mental health assessments. Engagement in mental health therapy is not required beyond the initial evaluation (as many adolescents are well adjusted), but it is encouraged for support during the adolescent’s transition.4 It is important to note that the decision to begin hormones, or not, as well as how to adjust dosing over time, is nuanced and is individualized to each patient’s particular goals for his/her/their transition.
Care for transmasculine identified adolescents (those who were assigned female at birth) typically involves testosterone, delivered via subcutaneous injection, transdermal patch, or transdermal gel. Care for transfeminine individuals (those who were assigned male at birth) typically involves estradiol, delivered via daily pill, weekly or twice weekly transdermal patch, or intramuscular injection, as well as an androgen blocker. This is because estradiol by itself is a weak androgen inhibitor. Antiandrogen medication is delivered by daily oral spironolactone, daily oral bicalutamide (an androgen receptor blocker), or GnRH agonists similar to those used for puberty blockade.
Outcomes
At least 13 studies have documented an improvement in gender dysphoria and/or mental health for adolescents and young adults after beginning gender affirming medical care.5 A recent study by Turban et al. showed that access to gender affirming hormones during adolescence or early adulthood was associated with decreased odds of past month suicidal ideation than for those who did not have access to gender-affirming hormones.6 Tordoff et al. found that receipt of gender-affirming care, including medications, led to a 60% decrease in depressive symptoms and a 73% decrease in suicidality.7 One other question that often arises is whether youth who undergo medical treatment for their transition regret their transition or retransition back to the sex they were assigned at birth. In a large study at a gender clinic in the United Kingdom, they found a regret rate of only 0.47% (16 of 3,398 adolescents aged 13-20).8 This is similar to other studies that have also found low rates of regret. Regret is often due to lack of acceptance in society rather than lack of transgender identity.
The care of gender diverse youth takes place on a spectrum, including options that do not include medical treatment. By supporting youth where they are on their gender journey, there is a significant reduction in adverse mental health outcomes. Gender-affirming hormonal treatment is individualized and a thorough multidisciplinary evaluation and informed consent are obtained prior to initiation. There are careful, nuanced discussions with patients and their families to individualize care based on individual goals. By following established evidence-based standards of care, physicians can support their gender-diverse patients throughout their gender journey. Just like other medical treatments, procedures, or surgeries, gender-affirming care should be undertaken in the context of the sacred patient-physician relationship.
Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas.
References
1. Equality Texas. Legislative Bill Tracker.
2. James SE et al. The Report of the 2015 U.S. Transgender Survey. 2016. Washington, DC: National Center for Transgender Equality.
3. The Trevor Project. 2020. National Survey on LGBTQ Mental Health.
4. Lopez X et al. Curr Opin Pediatrics. 2017;29(4):475-80.
5. Turban J. The evidence for trans youth gender-affirming medical care. Psychology Today. 2022 Jan 24.
6. Turban J et al. Access to gender-affirming hormones during adolescence and mental health outcomes among transgender adults. PLOS ONE. 2022;17(1).
7. Tordoff DM et al. Mental health outcomes in transgender and nonbinary youths receiving gender-affirming care. JAMA Network Open. 2022;5(2).
8. Davies S et al. Detransition rates in a national UK gender identity clinic. Inside Matters. On Law, Ethics, and Religion. 2019 Apr 11.
“Texas investigates parents of transgender teen.” “Court did not force dad to allow chemical castration of son.” Headlines such as these are becoming more common as transgender adolescents and young adults, as well as their families, continue to come under attack from state and local governments. In the 2021 state legislative sessions, more than 100 anti-trans bills were filed across 35 state legislatures. Texas alone saw 13 anti-trans bills, covering everything from sports participation to criminalization of best-practice medical care.1 Many of these bills are introduced under the guise of “protecting” these adolescents and young adults but are detrimental to their health. They also contain descriptions of gender-affirming care that do not reflect the evidence-based standards of care followed by clinicians across the country. Below is scientifically accurate information on gender-affirming care.
Gender identity development
Trajectories of gender identity are diverse. In a large sample of transgender adults (n = 27,715), 10% started to realize they were transgender at age 5 or younger, 16% between ages 6 and 10, 28% between 11 and 15, 29% between 16 and 20, and 18% at age 21 or older.2 In childhood, cross-gender play and preferences are a normal part of gender expression and many gender-nonconforming children will go on to identify with the sex they were assigned at birth (labeled cisgender). However, some children explicitly identify with a gender different than the sex they were assigned at birth (labeled transgender). Children who are consistent, insistent, and persistent in this identity appear likely to remain so into adolescence and adulthood. It is important to note that there is no evidence that discouraging gender nonconformity decreases the likelihood that a child will identify as transgender. In fact, this practice is no longer considered ethical, as it can have damaging effects on self-esteem and mental health. In addition, not all transgender people are noticeably gender nonconforming in childhood and that lack of childhood gender nonconformity does not invalidate someone’s transgender identity.
Gender-affirming care
For youth who identify as transgender, all steps in transition prior to puberty are social. This includes steps like changing hairstyles or clothing and using a different (affirmed) name and/or pronouns. This time period allows youth to explore their gender identity and expression. In one large study of 10,000 LGBTQ youth, among youth who reported “all or most people” used their affirmed pronoun, 12% reported a history of suicide attempt.3 In comparison, among those who reported that “no one” used their affirmed pronoun, the suicide attempt rate was 28%. Further, 14% of youth who reported that they were able to make changes in their clothing and appearance reported a past suicide attempt in comparison to 26% of those who were not able to. Many of these youth also are under the care of mental health professionals during this time.
At the onset of puberty, transgender youth are eligible for medical management, if needed, to address gender dysphoria (i.e., distress with one’s sex characteristics that is consistent and impairing). It is important to recognize that not all people who identify as transgender experience gender dysphoria or desire a medical transition. For those who do seek medical care, puberty must be confirmed either by breast/testicular exam or checking gonadotropin levels. Standards of care suggest that prior to pubertal suppression with GnRH agonists, such as leuprolide or histrelin, adolescents undergo a thorough psychosocial evaluation by a qualified, licensed clinician. After this evaluation, pubertal suppression may be initiated. These adolescents are monitored by their physicians every 3-6 months for side effects and continuing evaluation of their gender identity. GnRH agonists pause any further pubertal development while the adolescent continues to explore his/her/their gender identity. GnRH agonists are fully reversible and if they are stopped, the child’s natal puberty would recommence.
If an adolescent desires to start gender-affirming hormones, these are started as early as age 14, depending on their maturity, when they desire to start, and/or their ability to obtain parental consent. If a patient has not begun GnRH agonists and undergone a previous psychosocial evaluation, a thorough psychosocial evaluation by a qualified, licensed clinician would take place prior to initiating gender-affirming hormones. Prior to initiating hormones, a thorough informed-consent process occurs between the clinician, patient, and family. This process reviews reversible versus irreversible effects, as well of any side effects of the medication(s). Adolescents who begin hormonal treatment are then monitored every 3-6 months for medication side effects, efficacy, satisfaction with treatment, and by continued mental health assessments. Engagement in mental health therapy is not required beyond the initial evaluation (as many adolescents are well adjusted), but it is encouraged for support during the adolescent’s transition.4 It is important to note that the decision to begin hormones, or not, as well as how to adjust dosing over time, is nuanced and is individualized to each patient’s particular goals for his/her/their transition.
Care for transmasculine identified adolescents (those who were assigned female at birth) typically involves testosterone, delivered via subcutaneous injection, transdermal patch, or transdermal gel. Care for transfeminine individuals (those who were assigned male at birth) typically involves estradiol, delivered via daily pill, weekly or twice weekly transdermal patch, or intramuscular injection, as well as an androgen blocker. This is because estradiol by itself is a weak androgen inhibitor. Antiandrogen medication is delivered by daily oral spironolactone, daily oral bicalutamide (an androgen receptor blocker), or GnRH agonists similar to those used for puberty blockade.
Outcomes
At least 13 studies have documented an improvement in gender dysphoria and/or mental health for adolescents and young adults after beginning gender affirming medical care.5 A recent study by Turban et al. showed that access to gender affirming hormones during adolescence or early adulthood was associated with decreased odds of past month suicidal ideation than for those who did not have access to gender-affirming hormones.6 Tordoff et al. found that receipt of gender-affirming care, including medications, led to a 60% decrease in depressive symptoms and a 73% decrease in suicidality.7 One other question that often arises is whether youth who undergo medical treatment for their transition regret their transition or retransition back to the sex they were assigned at birth. In a large study at a gender clinic in the United Kingdom, they found a regret rate of only 0.47% (16 of 3,398 adolescents aged 13-20).8 This is similar to other studies that have also found low rates of regret. Regret is often due to lack of acceptance in society rather than lack of transgender identity.
The care of gender diverse youth takes place on a spectrum, including options that do not include medical treatment. By supporting youth where they are on their gender journey, there is a significant reduction in adverse mental health outcomes. Gender-affirming hormonal treatment is individualized and a thorough multidisciplinary evaluation and informed consent are obtained prior to initiation. There are careful, nuanced discussions with patients and their families to individualize care based on individual goals. By following established evidence-based standards of care, physicians can support their gender-diverse patients throughout their gender journey. Just like other medical treatments, procedures, or surgeries, gender-affirming care should be undertaken in the context of the sacred patient-physician relationship.
Dr. Cooper is assistant professor of pediatrics at University of Texas Southwestern, Dallas, and an adolescent medicine specialist at Children’s Medical Center Dallas.
References
1. Equality Texas. Legislative Bill Tracker.
2. James SE et al. The Report of the 2015 U.S. Transgender Survey. 2016. Washington, DC: National Center for Transgender Equality.
3. The Trevor Project. 2020. National Survey on LGBTQ Mental Health.
4. Lopez X et al. Curr Opin Pediatrics. 2017;29(4):475-80.
5. Turban J. The evidence for trans youth gender-affirming medical care. Psychology Today. 2022 Jan 24.
6. Turban J et al. Access to gender-affirming hormones during adolescence and mental health outcomes among transgender adults. PLOS ONE. 2022;17(1).
7. Tordoff DM et al. Mental health outcomes in transgender and nonbinary youths receiving gender-affirming care. JAMA Network Open. 2022;5(2).
8. Davies S et al. Detransition rates in a national UK gender identity clinic. Inside Matters. On Law, Ethics, and Religion. 2019 Apr 11.
Depression strikes more than half of obese adolescents
More than 50% of obese adolescents met criteria for depression, which also was associated with several components of metabolic syndrome, based on data from 160 individuals.
Previous research shows that the metabolic consequences of obesity are worsened with the coexistence of depression in adults, but a similar relationship in obese adolescents has not been explored, according to Nisha Gupta, a medical student at the University of Texas Health Science Center, Houston, and colleagues.
“This relationship is explained by an overactive stress response and adoption of unhealthy lifestyle habits,” both of which increased during the COVID-19 pandemic, the researchers noted in their abstract.
In a study presented at the Pediatric Academic Societies annual meeting, the researchers reviewed data from 160 obese adolescents seen at a pediatric weight management clinic between July 1, 2018, and Dec. 3, 2021. The data included anthropometric, clinical, and laboratory information. Depression was assessed using the Patient Health Questionnaire–9 (PHQ-9). The goal of the study was to compare the prevalence of metabolic syndrome components in obese youth with and without diagnosed depression.
Overall, 46% of the patients had PHQ-9 scores less than 5, which was defined as no clinically significant depression. A total of 26% had current or prior diagnoses of depression, and 25% met the criteria for moderate to severe depression, with PHQ-9 scores of 10 or higher. Notably, 18% of individuals with no prior history of depression met criteria for moderate to severe depression, the researchers wrote.
Teens who reported daytime fatigue or trouble sleeping, and those who reported eating out seven or more times a week had higher scores than those without these reports.
In laboratory analyses, higher PHQ-9 scores were significantly associated with increasing weight, body mass index, body fat percentage, diastolic blood pressure, and fasting blood insulin (P < .02 for all).
The study findings were limited by the relatively small sample size, the researchers noted. However, the results suggest that depression is common, but often underdiagnosed in obese adolescents, and depression screening should be part of obesity management.
Study highlights need to screen
The current study is important because of the overall increase in obesity in the United States, which extends to children and teens, Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.
“With skyrocketing rates of obesity among children and teens over the last decades, we are seeing more ‘adult’ diseases seep into the younger ages, including type 2 diabetes, high blood pressure and now, depression,” he said.
“The results are a wake-up call for the need for better system-wide prevention and management of obesity in adolescents and the importance of screening and managing depression in obese teenagers,” he emphasized.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
More than 50% of obese adolescents met criteria for depression, which also was associated with several components of metabolic syndrome, based on data from 160 individuals.
Previous research shows that the metabolic consequences of obesity are worsened with the coexistence of depression in adults, but a similar relationship in obese adolescents has not been explored, according to Nisha Gupta, a medical student at the University of Texas Health Science Center, Houston, and colleagues.
“This relationship is explained by an overactive stress response and adoption of unhealthy lifestyle habits,” both of which increased during the COVID-19 pandemic, the researchers noted in their abstract.
In a study presented at the Pediatric Academic Societies annual meeting, the researchers reviewed data from 160 obese adolescents seen at a pediatric weight management clinic between July 1, 2018, and Dec. 3, 2021. The data included anthropometric, clinical, and laboratory information. Depression was assessed using the Patient Health Questionnaire–9 (PHQ-9). The goal of the study was to compare the prevalence of metabolic syndrome components in obese youth with and without diagnosed depression.
Overall, 46% of the patients had PHQ-9 scores less than 5, which was defined as no clinically significant depression. A total of 26% had current or prior diagnoses of depression, and 25% met the criteria for moderate to severe depression, with PHQ-9 scores of 10 or higher. Notably, 18% of individuals with no prior history of depression met criteria for moderate to severe depression, the researchers wrote.
Teens who reported daytime fatigue or trouble sleeping, and those who reported eating out seven or more times a week had higher scores than those without these reports.
In laboratory analyses, higher PHQ-9 scores were significantly associated with increasing weight, body mass index, body fat percentage, diastolic blood pressure, and fasting blood insulin (P < .02 for all).
The study findings were limited by the relatively small sample size, the researchers noted. However, the results suggest that depression is common, but often underdiagnosed in obese adolescents, and depression screening should be part of obesity management.
Study highlights need to screen
The current study is important because of the overall increase in obesity in the United States, which extends to children and teens, Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.
“With skyrocketing rates of obesity among children and teens over the last decades, we are seeing more ‘adult’ diseases seep into the younger ages, including type 2 diabetes, high blood pressure and now, depression,” he said.
“The results are a wake-up call for the need for better system-wide prevention and management of obesity in adolescents and the importance of screening and managing depression in obese teenagers,” he emphasized.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
More than 50% of obese adolescents met criteria for depression, which also was associated with several components of metabolic syndrome, based on data from 160 individuals.
Previous research shows that the metabolic consequences of obesity are worsened with the coexistence of depression in adults, but a similar relationship in obese adolescents has not been explored, according to Nisha Gupta, a medical student at the University of Texas Health Science Center, Houston, and colleagues.
“This relationship is explained by an overactive stress response and adoption of unhealthy lifestyle habits,” both of which increased during the COVID-19 pandemic, the researchers noted in their abstract.
In a study presented at the Pediatric Academic Societies annual meeting, the researchers reviewed data from 160 obese adolescents seen at a pediatric weight management clinic between July 1, 2018, and Dec. 3, 2021. The data included anthropometric, clinical, and laboratory information. Depression was assessed using the Patient Health Questionnaire–9 (PHQ-9). The goal of the study was to compare the prevalence of metabolic syndrome components in obese youth with and without diagnosed depression.
Overall, 46% of the patients had PHQ-9 scores less than 5, which was defined as no clinically significant depression. A total of 26% had current or prior diagnoses of depression, and 25% met the criteria for moderate to severe depression, with PHQ-9 scores of 10 or higher. Notably, 18% of individuals with no prior history of depression met criteria for moderate to severe depression, the researchers wrote.
Teens who reported daytime fatigue or trouble sleeping, and those who reported eating out seven or more times a week had higher scores than those without these reports.
In laboratory analyses, higher PHQ-9 scores were significantly associated with increasing weight, body mass index, body fat percentage, diastolic blood pressure, and fasting blood insulin (P < .02 for all).
The study findings were limited by the relatively small sample size, the researchers noted. However, the results suggest that depression is common, but often underdiagnosed in obese adolescents, and depression screening should be part of obesity management.
Study highlights need to screen
The current study is important because of the overall increase in obesity in the United States, which extends to children and teens, Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.
“With skyrocketing rates of obesity among children and teens over the last decades, we are seeing more ‘adult’ diseases seep into the younger ages, including type 2 diabetes, high blood pressure and now, depression,” he said.
“The results are a wake-up call for the need for better system-wide prevention and management of obesity in adolescents and the importance of screening and managing depression in obese teenagers,” he emphasized.
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
FROM PAS 2022
Gun violence now leading cause of death for U.S. children
In 2020, 4,357 children aged 1-19, or approximately 6 in 100,000, died from a gun-related injury, the researchers reported, modestly exceeding the number for auto accidents (3,913) and greatly exceeding deaths caused by suffocation (1,411) or drowning (966).
To observers of gun violence in this country, the grim statistical marker has been all but inevitable. Gunshots were the second-leading cause of death in 2016 among children aged 1-19, the researchers reported. But sharp rises in such fatalities since then, especially in 2020 as the COVID-19 pandemic began, pushed the death toll above all other causes among Americans in this age group.
Guns accounted for more than 45,000 deaths among all age groups in 2020, also a record, according to the U.S. Centers for Disease Control and Prevention.
Although gun deaths rose across nearly every racial and ethnic group, the increase was greatest among Black children. In this group, firearms accounted for more than 15 deaths per 100,000 children in 2020 – up from about 12 such deaths in 2019.
Homicide was the leading cause of gun deaths, followed by suicide and then accidental shootings, although the reason for some deaths could not be determined, according to the researchers.
The researchers reported their findings in the New England Journal of Medicine.
Gun deaths among children are preventable, both researchers and advocates said.
“There are ways to reduce injuries without banning guns,” said Jason Goldstick, PhD, a statistician at the University of Michigan, Ann Arbor, who led the study.
Dr. Goldstick pointed to significant investments in car vehicle safety as a model for policy makers to follow today for making gun injuries less frequent and deadly.
“More people drive today than in the 1970s, and motor vehicle–related injury rates are much lower,” Dr. Goldstick said. Innovations like seatbelt laws and changes in how cars are built have made them less deadly during a crash. Similar innovations are possible in how guns are managed.
More than 4.6 million U.S. children live in homes with unsecured firearms, according to Shannon Watts of the advocacy organization Moms Demand Action. “Securely storing firearms unloaded, locked and separate from ammunition is a simple yet lifesaving action that all gun owners should follow – and lawmakers should require,” she said in a statement to this news organization.
“The effects of gun violence ripple far beyond the child who was struck by a bullet,” said Sarah Burd-Sharps, the senior director of research for the advocacy organization Everytown for Gun Safety. Children might grieve their friends who are now lost or worry that they will be next.
The data in this study aren’t surprising, Ms. Burd-Sharps said, given the large number of homes in which guns are unsecured and the sharp rise in gun sales during the pandemic. On average one child per day in the United States accesses an unsecured gun that ends up injuring or killing themself or someone else.
“Gun owners want to be responsible. These deaths are really preventable,” Ms. Burd-Sharps said. In addition to securing ammunition and firearms separately, she recommended wider use of biometric guns that can only be used by someone with a specific fingerprint. If a young person got ahold of such a gun, even if it was loaded, they couldn’t use it.
The researchers reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
In 2020, 4,357 children aged 1-19, or approximately 6 in 100,000, died from a gun-related injury, the researchers reported, modestly exceeding the number for auto accidents (3,913) and greatly exceeding deaths caused by suffocation (1,411) or drowning (966).
To observers of gun violence in this country, the grim statistical marker has been all but inevitable. Gunshots were the second-leading cause of death in 2016 among children aged 1-19, the researchers reported. But sharp rises in such fatalities since then, especially in 2020 as the COVID-19 pandemic began, pushed the death toll above all other causes among Americans in this age group.
Guns accounted for more than 45,000 deaths among all age groups in 2020, also a record, according to the U.S. Centers for Disease Control and Prevention.
Although gun deaths rose across nearly every racial and ethnic group, the increase was greatest among Black children. In this group, firearms accounted for more than 15 deaths per 100,000 children in 2020 – up from about 12 such deaths in 2019.
Homicide was the leading cause of gun deaths, followed by suicide and then accidental shootings, although the reason for some deaths could not be determined, according to the researchers.
The researchers reported their findings in the New England Journal of Medicine.
Gun deaths among children are preventable, both researchers and advocates said.
“There are ways to reduce injuries without banning guns,” said Jason Goldstick, PhD, a statistician at the University of Michigan, Ann Arbor, who led the study.
Dr. Goldstick pointed to significant investments in car vehicle safety as a model for policy makers to follow today for making gun injuries less frequent and deadly.
“More people drive today than in the 1970s, and motor vehicle–related injury rates are much lower,” Dr. Goldstick said. Innovations like seatbelt laws and changes in how cars are built have made them less deadly during a crash. Similar innovations are possible in how guns are managed.
More than 4.6 million U.S. children live in homes with unsecured firearms, according to Shannon Watts of the advocacy organization Moms Demand Action. “Securely storing firearms unloaded, locked and separate from ammunition is a simple yet lifesaving action that all gun owners should follow – and lawmakers should require,” she said in a statement to this news organization.
“The effects of gun violence ripple far beyond the child who was struck by a bullet,” said Sarah Burd-Sharps, the senior director of research for the advocacy organization Everytown for Gun Safety. Children might grieve their friends who are now lost or worry that they will be next.
The data in this study aren’t surprising, Ms. Burd-Sharps said, given the large number of homes in which guns are unsecured and the sharp rise in gun sales during the pandemic. On average one child per day in the United States accesses an unsecured gun that ends up injuring or killing themself or someone else.
“Gun owners want to be responsible. These deaths are really preventable,” Ms. Burd-Sharps said. In addition to securing ammunition and firearms separately, she recommended wider use of biometric guns that can only be used by someone with a specific fingerprint. If a young person got ahold of such a gun, even if it was loaded, they couldn’t use it.
The researchers reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
In 2020, 4,357 children aged 1-19, or approximately 6 in 100,000, died from a gun-related injury, the researchers reported, modestly exceeding the number for auto accidents (3,913) and greatly exceeding deaths caused by suffocation (1,411) or drowning (966).
To observers of gun violence in this country, the grim statistical marker has been all but inevitable. Gunshots were the second-leading cause of death in 2016 among children aged 1-19, the researchers reported. But sharp rises in such fatalities since then, especially in 2020 as the COVID-19 pandemic began, pushed the death toll above all other causes among Americans in this age group.
Guns accounted for more than 45,000 deaths among all age groups in 2020, also a record, according to the U.S. Centers for Disease Control and Prevention.
Although gun deaths rose across nearly every racial and ethnic group, the increase was greatest among Black children. In this group, firearms accounted for more than 15 deaths per 100,000 children in 2020 – up from about 12 such deaths in 2019.
Homicide was the leading cause of gun deaths, followed by suicide and then accidental shootings, although the reason for some deaths could not be determined, according to the researchers.
The researchers reported their findings in the New England Journal of Medicine.
Gun deaths among children are preventable, both researchers and advocates said.
“There are ways to reduce injuries without banning guns,” said Jason Goldstick, PhD, a statistician at the University of Michigan, Ann Arbor, who led the study.
Dr. Goldstick pointed to significant investments in car vehicle safety as a model for policy makers to follow today for making gun injuries less frequent and deadly.
“More people drive today than in the 1970s, and motor vehicle–related injury rates are much lower,” Dr. Goldstick said. Innovations like seatbelt laws and changes in how cars are built have made them less deadly during a crash. Similar innovations are possible in how guns are managed.
More than 4.6 million U.S. children live in homes with unsecured firearms, according to Shannon Watts of the advocacy organization Moms Demand Action. “Securely storing firearms unloaded, locked and separate from ammunition is a simple yet lifesaving action that all gun owners should follow – and lawmakers should require,” she said in a statement to this news organization.
“The effects of gun violence ripple far beyond the child who was struck by a bullet,” said Sarah Burd-Sharps, the senior director of research for the advocacy organization Everytown for Gun Safety. Children might grieve their friends who are now lost or worry that they will be next.
The data in this study aren’t surprising, Ms. Burd-Sharps said, given the large number of homes in which guns are unsecured and the sharp rise in gun sales during the pandemic. On average one child per day in the United States accesses an unsecured gun that ends up injuring or killing themself or someone else.
“Gun owners want to be responsible. These deaths are really preventable,” Ms. Burd-Sharps said. In addition to securing ammunition and firearms separately, she recommended wider use of biometric guns that can only be used by someone with a specific fingerprint. If a young person got ahold of such a gun, even if it was loaded, they couldn’t use it.
The researchers reported no relevant financial conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Program successfully boosts pediatric cancer research
Even within the first year of implementation, the Research to Accelerate Cures and Equity (RACE) for Children Act has made an impact.
“In the year prior to RACE implementation, there were no approvals of therapeutics that required pediatric studies,” said Brittany Avin McKelvey, PhD, science policy analyst with Friends of Cancer Research and a childhood cancer survivor. “”
The legislation was passed by Congress in 2017 and took effect in August 2020. It requires that therapeutics that are approved for adult cancers be tested in pediatric cancers if those drugs are directed at molecular targets relevant for pediatric cancers.
The RACE Act also requires testing of therapeutics that are given an orphan drug designation. Such drugs were previously exempt from pediatric trials.
Dr. McKelvey presented the new findings at the annual meeting of the American Association for Cancer Research.
To evaluate the impact of the RACE Act during the first year of its implementation, her team assessed all the new cancer drugs approved between August 2019 and August 2021.
Nineteen drugs were identified; 63.2% were approved in the year before the RACE Act took effect, and 36.8% were approved after its implementation. The team suspects that the coronavirus pandemic may have contributed to the lower number of post-RACE approvals.
The researchers found that prior to implementation of the RACE Act, none of the approved adult cancer therapeutics were required to be studied in pediatric populations. But more than 90% of those had molecular targets that would have required that they be studied in pediatric cancers had the RACE Act been in place. The majority of these drugs were exempt because of their designation as orphan drugs.
In the post-RACE group, however, 42.9% of approved drugs are required to be studied in pediatric cancers. One example is infigratinib (Truseltiq), a drug for adult cholangiocarcinoma that targets the protein fibroblast growth factor receptor 2 (FGFR2). Truseltiq is an orphan drug – and thus would have been exempt prior to the RACE Act – but it will now be studied in pediatric patients with advanced or metastatic tumors harboring alterations in FGFR2.
“I find these results encouraging, but it is still very early,” said John Maris, MD, an attending physician and professor of pediatrics at the Children’s Hospital of Philadelphia, who was not involved in the study. “This is only 1 year into implementation, and this legislation will be around for a long time.”
In an interview, Dr. McKelvey noted that although a handful of clinical trials for pediatric cancers have been launched since implementation of RACE, many drugs are still being waived for pediatric study even when a relevant mechanism of action is present – largely because the extremely low incidence of many childhood cancers makes it impractical or, in some cases, impossible to conduct such studies. “This highlights the need for additional opportunities to help facilitate and encourage robust pediatric studies,” she said.
The main limitation of the study is that it examined data 1 year after the implementation of the RACE Act; further analysis is needed to determine the full extent of its impact, Dr. McKelvey said. “The true measure of success will be determined by whether increased pediatric studies actually translate to label expansions for pediatric patient populations and access to these therapies.”
The study was supported by funding from Friends of Cancer Research.
A version of this article first appeared on Medscape.com.
Even within the first year of implementation, the Research to Accelerate Cures and Equity (RACE) for Children Act has made an impact.
“In the year prior to RACE implementation, there were no approvals of therapeutics that required pediatric studies,” said Brittany Avin McKelvey, PhD, science policy analyst with Friends of Cancer Research and a childhood cancer survivor. “”
The legislation was passed by Congress in 2017 and took effect in August 2020. It requires that therapeutics that are approved for adult cancers be tested in pediatric cancers if those drugs are directed at molecular targets relevant for pediatric cancers.
The RACE Act also requires testing of therapeutics that are given an orphan drug designation. Such drugs were previously exempt from pediatric trials.
Dr. McKelvey presented the new findings at the annual meeting of the American Association for Cancer Research.
To evaluate the impact of the RACE Act during the first year of its implementation, her team assessed all the new cancer drugs approved between August 2019 and August 2021.
Nineteen drugs were identified; 63.2% were approved in the year before the RACE Act took effect, and 36.8% were approved after its implementation. The team suspects that the coronavirus pandemic may have contributed to the lower number of post-RACE approvals.
The researchers found that prior to implementation of the RACE Act, none of the approved adult cancer therapeutics were required to be studied in pediatric populations. But more than 90% of those had molecular targets that would have required that they be studied in pediatric cancers had the RACE Act been in place. The majority of these drugs were exempt because of their designation as orphan drugs.
In the post-RACE group, however, 42.9% of approved drugs are required to be studied in pediatric cancers. One example is infigratinib (Truseltiq), a drug for adult cholangiocarcinoma that targets the protein fibroblast growth factor receptor 2 (FGFR2). Truseltiq is an orphan drug – and thus would have been exempt prior to the RACE Act – but it will now be studied in pediatric patients with advanced or metastatic tumors harboring alterations in FGFR2.
“I find these results encouraging, but it is still very early,” said John Maris, MD, an attending physician and professor of pediatrics at the Children’s Hospital of Philadelphia, who was not involved in the study. “This is only 1 year into implementation, and this legislation will be around for a long time.”
In an interview, Dr. McKelvey noted that although a handful of clinical trials for pediatric cancers have been launched since implementation of RACE, many drugs are still being waived for pediatric study even when a relevant mechanism of action is present – largely because the extremely low incidence of many childhood cancers makes it impractical or, in some cases, impossible to conduct such studies. “This highlights the need for additional opportunities to help facilitate and encourage robust pediatric studies,” she said.
The main limitation of the study is that it examined data 1 year after the implementation of the RACE Act; further analysis is needed to determine the full extent of its impact, Dr. McKelvey said. “The true measure of success will be determined by whether increased pediatric studies actually translate to label expansions for pediatric patient populations and access to these therapies.”
The study was supported by funding from Friends of Cancer Research.
A version of this article first appeared on Medscape.com.
Even within the first year of implementation, the Research to Accelerate Cures and Equity (RACE) for Children Act has made an impact.
“In the year prior to RACE implementation, there were no approvals of therapeutics that required pediatric studies,” said Brittany Avin McKelvey, PhD, science policy analyst with Friends of Cancer Research and a childhood cancer survivor. “”
The legislation was passed by Congress in 2017 and took effect in August 2020. It requires that therapeutics that are approved for adult cancers be tested in pediatric cancers if those drugs are directed at molecular targets relevant for pediatric cancers.
The RACE Act also requires testing of therapeutics that are given an orphan drug designation. Such drugs were previously exempt from pediatric trials.
Dr. McKelvey presented the new findings at the annual meeting of the American Association for Cancer Research.
To evaluate the impact of the RACE Act during the first year of its implementation, her team assessed all the new cancer drugs approved between August 2019 and August 2021.
Nineteen drugs were identified; 63.2% were approved in the year before the RACE Act took effect, and 36.8% were approved after its implementation. The team suspects that the coronavirus pandemic may have contributed to the lower number of post-RACE approvals.
The researchers found that prior to implementation of the RACE Act, none of the approved adult cancer therapeutics were required to be studied in pediatric populations. But more than 90% of those had molecular targets that would have required that they be studied in pediatric cancers had the RACE Act been in place. The majority of these drugs were exempt because of their designation as orphan drugs.
In the post-RACE group, however, 42.9% of approved drugs are required to be studied in pediatric cancers. One example is infigratinib (Truseltiq), a drug for adult cholangiocarcinoma that targets the protein fibroblast growth factor receptor 2 (FGFR2). Truseltiq is an orphan drug – and thus would have been exempt prior to the RACE Act – but it will now be studied in pediatric patients with advanced or metastatic tumors harboring alterations in FGFR2.
“I find these results encouraging, but it is still very early,” said John Maris, MD, an attending physician and professor of pediatrics at the Children’s Hospital of Philadelphia, who was not involved in the study. “This is only 1 year into implementation, and this legislation will be around for a long time.”
In an interview, Dr. McKelvey noted that although a handful of clinical trials for pediatric cancers have been launched since implementation of RACE, many drugs are still being waived for pediatric study even when a relevant mechanism of action is present – largely because the extremely low incidence of many childhood cancers makes it impractical or, in some cases, impossible to conduct such studies. “This highlights the need for additional opportunities to help facilitate and encourage robust pediatric studies,” she said.
The main limitation of the study is that it examined data 1 year after the implementation of the RACE Act; further analysis is needed to determine the full extent of its impact, Dr. McKelvey said. “The true measure of success will be determined by whether increased pediatric studies actually translate to label expansions for pediatric patient populations and access to these therapies.”
The study was supported by funding from Friends of Cancer Research.
A version of this article first appeared on Medscape.com.
FROM AACR 2022