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A patient named ‘Settle’ decides to sue instead

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A West Virginia medical center is being sued by a man who claims that the hospital lied about removing his appendix, a story in the West Virginia Record reports.

On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.

Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.

Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.

Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.

Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.

His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.

Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.

Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.

Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”

His suit seeks not only compensatory damages and other relief but also punitive damages.

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

A version of this article originally appeared on Medscape.com.

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A West Virginia medical center is being sued by a man who claims that the hospital lied about removing his appendix, a story in the West Virginia Record reports.

On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.

Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.

Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.

Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.

Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.

His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.

Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.

Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.

Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”

His suit seeks not only compensatory damages and other relief but also punitive damages.

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

A version of this article originally appeared on Medscape.com.

A West Virginia medical center is being sued by a man who claims that the hospital lied about removing his appendix, a story in the West Virginia Record reports.

On Nov. 1, 2020, Dallas Settle went to Plateau Medical Center, Oak Hill, W.Va., complaining of pain that was later described in court documents as being “in his right mid-abdomen migrating to his right lower abdomen.” Following a CT scan, Mr. Settle was diagnosed with diverticulitis resulting in pneumoperitoneum, which is the presence of air or other gas in the abdominal cavity. The patient, it was decided, required surgery to correct the problem, but Plateau Medical Center didn’t have the staff to perform the procedure.

Mr. Settle was then transferred to another West Virginia hospital, Charleston Area Medical Center (CAMC). Here, he was evaluated by doctors in the facility’s General Division, who initiated treatment with IV fluids and opiate analgesics. He was then placed under the care of a trauma surgeon, who initially decided to treat the patient nonoperatively. If that approach failed, the surgeon believed, Mr. Settle would probably require a laparotomy, bowel resection, and ostomy.

Another surgical team performed an exploratory laparotomy the following day. The team determined that Mr. Settle was suffering from a ruptured appendicitis and allegedly performed an appendectomy. But Mr. Settle’s condition continued to deteriorate the following day.

Another CT scan followed. It revealed various problems – multiple fluid collections, an ileus, distended loops of the patient’s small bowel, a left renal cyst, subcentimeter mesenteric, and retroperitoneal adenopathy. Additional CT scans conducted 4 days later indicated other problems, including fluid collections in the patient’s right- and left-lower quadrants.

Over the next few days, doctors performed further exploratory laparotomies. Finally, on Nov. 22, Mr. Settle was transferred out of the intensive care unit in preparation for his discharge the following day.

His pain continued to worsen, however, and he was readmitted to CAMC a day later. At this point, an examination revealed that his surgical incisions had become infected.

Worse news was on the horizon. On Nov. 28, the trauma surgeon who had first agreed to treat Mr. Settle informed him that, despite claims to the contrary, his appendix hadn’t been removed.

Eventually, Mr. Settle was referred to the Cleveland Clinic, where at press time he was still being treated.

Mr. Settle has hired the firm Calwell Luce diTrapano to sue CAMC, accusing it of medical malpractice, medical negligence, and other lapses in the standard of care. In his complaint, he accused the hospital and its staff of breaching their duty of care “by negligently and improperly treating him” and by failing “to exercise the degree of care, skill, and learning required and expected of reasonable health care providers.”

His suit seeks not only compensatory damages and other relief but also punitive damages.

The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.

A version of this article originally appeared on Medscape.com.

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Hope for catching infants with CP early

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A new prognostic tool may help identify infants with cerebral palsy (CP) earlier, allowing them to receive therapies to improve later outcomes.
 

Researchers from Canada used 12 clinical variables to predict the condition. The tool accurately predicted 75% of CP cases. The study was published in JAMA Pediatrics.

The prevalence of CP in the United States is 2-3 children per 1,000, a rate that has been relatively unchanged for decades. Although recent innovations in diagnosis using motor scores and MRI scans have aided in diagnosis, these techniques have historically been reserved only for infants who were cared for in neonatal intensive care units, were born prematurely, or who had other neurologic risk factors, such as birth defects.

The tool identified 2.4 times more children with CP than would have been detected using current diagnostic methods, according to the researchers.

“We developed the prediction tool to try to make these findings accessible to any health care provider, which will hopefully help break down the long-held perception that CP is usually related to prematurity or a difficult delivery,” said Mary Dunbar, MD, an author of the study. “We know that about half of children with CP aren’t premature and didn’t have a particularly difficult birth.”

The bedside tool weighs factors such as the use by mothers of illicit drugs and tobacco; the presence of diabetes and preeclampsia during pregnancy; whether the infant is male; birth weight; and the number of miscarriages the mother had prior to the birth. The tool also factors in results from a test that measures how well the infant is adjusting to life outside the womb.

Dr. Dunbar and colleagues compared 1,265 infants with CP from the Canadian Cerebral Palsy Registry from 2003 to 2019 with a control group of 1,985 children without CP from the Alberta Pregnancy Outcomes and Nutrition longitudinal study.

The study authors hope that the prognostic tool can be integrated into existing newborn screenings and completed by nurses or physicians as part of routine care.

“Its cost is low especially in comparison to MRI and specialized neurological assessments,” said Sarah Taylor, MD, section chief of neonatal-perinatal medicine at Yale New Haven Children’s Hospital in New Haven, Conn. Health systems and doctors may be more apt to adopt the tool, since it does not require specialized equipment or training.
 

Surprising findings

Several clinical variables independently increased the risk of CP, including independent 5-minute Apgar test scores of <6, chorioamnionitis, and illicit drug use during the pregnancy. Dr. Dunbar and colleagues recommend that primary care clinicians provide enhanced surveillance for these infants.

“I think there are also really important public health implications to address maternal and reproductive health to support pregnant people, since this study shows that common pregnancy conditions that are potentially treatable may additively contribute to cerebral palsy risk,” said Dr. Dunbar, a pediatric neurologist and assistant professor at the University of Calgary (Alta.)

For infants identified as being at risk, the study authors also suggest that doctors conduct focused examinations for CP at 3-, 6- and 12-month well-baby visits. If results of an examination are abnormal, doctors can advise the caregiver to conduct an early expert evaluation for a general movements assessment. Interventions for children with CP usually start in the first few years of life and can include occupational therapy, use of orthotic devices, and medication.

Dr. Dunbar and colleagues acknowledge that the test is not perfect and that additional work is needed.

“As helpful as the prediction tool may be to identify cases of CP early, we know there are still a minority of CP cases that it won’t catch because they don’t have any of the known risk factors,” Dr. Dunbar said. “We’re currently working on further research about this unique group.”

The researchers cited several limitations to the dataset used in the study, including a control group that was skewed toward older patients and persons of higher socioeconomic status. In addition, the data included a greater proportion of White women than the average Canadian population.

The Canadian Cerebral Palsy Registry was supported by the NeuroDevNet, KidsBrainHealth, the Harvey Guyda Chair of McGill University, Montreal Children’s Hospital, and the Public Health Agency of Canada. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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A new prognostic tool may help identify infants with cerebral palsy (CP) earlier, allowing them to receive therapies to improve later outcomes.
 

Researchers from Canada used 12 clinical variables to predict the condition. The tool accurately predicted 75% of CP cases. The study was published in JAMA Pediatrics.

The prevalence of CP in the United States is 2-3 children per 1,000, a rate that has been relatively unchanged for decades. Although recent innovations in diagnosis using motor scores and MRI scans have aided in diagnosis, these techniques have historically been reserved only for infants who were cared for in neonatal intensive care units, were born prematurely, or who had other neurologic risk factors, such as birth defects.

The tool identified 2.4 times more children with CP than would have been detected using current diagnostic methods, according to the researchers.

“We developed the prediction tool to try to make these findings accessible to any health care provider, which will hopefully help break down the long-held perception that CP is usually related to prematurity or a difficult delivery,” said Mary Dunbar, MD, an author of the study. “We know that about half of children with CP aren’t premature and didn’t have a particularly difficult birth.”

The bedside tool weighs factors such as the use by mothers of illicit drugs and tobacco; the presence of diabetes and preeclampsia during pregnancy; whether the infant is male; birth weight; and the number of miscarriages the mother had prior to the birth. The tool also factors in results from a test that measures how well the infant is adjusting to life outside the womb.

Dr. Dunbar and colleagues compared 1,265 infants with CP from the Canadian Cerebral Palsy Registry from 2003 to 2019 with a control group of 1,985 children without CP from the Alberta Pregnancy Outcomes and Nutrition longitudinal study.

The study authors hope that the prognostic tool can be integrated into existing newborn screenings and completed by nurses or physicians as part of routine care.

“Its cost is low especially in comparison to MRI and specialized neurological assessments,” said Sarah Taylor, MD, section chief of neonatal-perinatal medicine at Yale New Haven Children’s Hospital in New Haven, Conn. Health systems and doctors may be more apt to adopt the tool, since it does not require specialized equipment or training.
 

Surprising findings

Several clinical variables independently increased the risk of CP, including independent 5-minute Apgar test scores of <6, chorioamnionitis, and illicit drug use during the pregnancy. Dr. Dunbar and colleagues recommend that primary care clinicians provide enhanced surveillance for these infants.

“I think there are also really important public health implications to address maternal and reproductive health to support pregnant people, since this study shows that common pregnancy conditions that are potentially treatable may additively contribute to cerebral palsy risk,” said Dr. Dunbar, a pediatric neurologist and assistant professor at the University of Calgary (Alta.)

For infants identified as being at risk, the study authors also suggest that doctors conduct focused examinations for CP at 3-, 6- and 12-month well-baby visits. If results of an examination are abnormal, doctors can advise the caregiver to conduct an early expert evaluation for a general movements assessment. Interventions for children with CP usually start in the first few years of life and can include occupational therapy, use of orthotic devices, and medication.

Dr. Dunbar and colleagues acknowledge that the test is not perfect and that additional work is needed.

“As helpful as the prediction tool may be to identify cases of CP early, we know there are still a minority of CP cases that it won’t catch because they don’t have any of the known risk factors,” Dr. Dunbar said. “We’re currently working on further research about this unique group.”

The researchers cited several limitations to the dataset used in the study, including a control group that was skewed toward older patients and persons of higher socioeconomic status. In addition, the data included a greater proportion of White women than the average Canadian population.

The Canadian Cerebral Palsy Registry was supported by the NeuroDevNet, KidsBrainHealth, the Harvey Guyda Chair of McGill University, Montreal Children’s Hospital, and the Public Health Agency of Canada. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

A new prognostic tool may help identify infants with cerebral palsy (CP) earlier, allowing them to receive therapies to improve later outcomes.
 

Researchers from Canada used 12 clinical variables to predict the condition. The tool accurately predicted 75% of CP cases. The study was published in JAMA Pediatrics.

The prevalence of CP in the United States is 2-3 children per 1,000, a rate that has been relatively unchanged for decades. Although recent innovations in diagnosis using motor scores and MRI scans have aided in diagnosis, these techniques have historically been reserved only for infants who were cared for in neonatal intensive care units, were born prematurely, or who had other neurologic risk factors, such as birth defects.

The tool identified 2.4 times more children with CP than would have been detected using current diagnostic methods, according to the researchers.

“We developed the prediction tool to try to make these findings accessible to any health care provider, which will hopefully help break down the long-held perception that CP is usually related to prematurity or a difficult delivery,” said Mary Dunbar, MD, an author of the study. “We know that about half of children with CP aren’t premature and didn’t have a particularly difficult birth.”

The bedside tool weighs factors such as the use by mothers of illicit drugs and tobacco; the presence of diabetes and preeclampsia during pregnancy; whether the infant is male; birth weight; and the number of miscarriages the mother had prior to the birth. The tool also factors in results from a test that measures how well the infant is adjusting to life outside the womb.

Dr. Dunbar and colleagues compared 1,265 infants with CP from the Canadian Cerebral Palsy Registry from 2003 to 2019 with a control group of 1,985 children without CP from the Alberta Pregnancy Outcomes and Nutrition longitudinal study.

The study authors hope that the prognostic tool can be integrated into existing newborn screenings and completed by nurses or physicians as part of routine care.

“Its cost is low especially in comparison to MRI and specialized neurological assessments,” said Sarah Taylor, MD, section chief of neonatal-perinatal medicine at Yale New Haven Children’s Hospital in New Haven, Conn. Health systems and doctors may be more apt to adopt the tool, since it does not require specialized equipment or training.
 

Surprising findings

Several clinical variables independently increased the risk of CP, including independent 5-minute Apgar test scores of <6, chorioamnionitis, and illicit drug use during the pregnancy. Dr. Dunbar and colleagues recommend that primary care clinicians provide enhanced surveillance for these infants.

“I think there are also really important public health implications to address maternal and reproductive health to support pregnant people, since this study shows that common pregnancy conditions that are potentially treatable may additively contribute to cerebral palsy risk,” said Dr. Dunbar, a pediatric neurologist and assistant professor at the University of Calgary (Alta.)

For infants identified as being at risk, the study authors also suggest that doctors conduct focused examinations for CP at 3-, 6- and 12-month well-baby visits. If results of an examination are abnormal, doctors can advise the caregiver to conduct an early expert evaluation for a general movements assessment. Interventions for children with CP usually start in the first few years of life and can include occupational therapy, use of orthotic devices, and medication.

Dr. Dunbar and colleagues acknowledge that the test is not perfect and that additional work is needed.

“As helpful as the prediction tool may be to identify cases of CP early, we know there are still a minority of CP cases that it won’t catch because they don’t have any of the known risk factors,” Dr. Dunbar said. “We’re currently working on further research about this unique group.”

The researchers cited several limitations to the dataset used in the study, including a control group that was skewed toward older patients and persons of higher socioeconomic status. In addition, the data included a greater proportion of White women than the average Canadian population.

The Canadian Cerebral Palsy Registry was supported by the NeuroDevNet, KidsBrainHealth, the Harvey Guyda Chair of McGill University, Montreal Children’s Hospital, and the Public Health Agency of Canada. The authors disclosed no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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FROM JAMA PEDIATRICS

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Should pediatricians fret over their falling board scores?

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Few pediatricians have warm, fuzzy memories about taking their initial board exam.

But many reacted strongly when they read a recent post on Twitter by Bryan Carmody, MD, who noted that the passing rate for first-time test takers had dipped to its lowest level in 5 years – hitting 81% in 2021, down from 91% 3 years earlier.

“It’s literally an awfully written exam,” replied one person who posted. Another asked: “At what point is the exam just not reflective of clinical practice?” And, inevitably, the question of the effect of COVID-19 surfaced: “Is any of this attributable to pulling early career physicians into the pandemic?”

But Dr. Carmody, an associate professor of pediatrics at the University of Eastern Virginia Medical School, Norfolk, isn’t buying that explanation. He researched board scores for internal medicine, general surgery, and family medicine for 2021. All were stable during the same period, he said, leading him to dismiss the idea that the pandemic drove the decline. “It’s not really clear to me why other specialties wouldn’t have seen similar drops,” Dr. Carmody said.

The slip has caught the attention of the American Board of Pediatrics, according to Judy Schaechter, MD, MBA, who was chair of the department of pediatrics at the University of Miami before taking her post as president and CEO of the American Board of Pediatrics in 2021.

“So, our first question was, was this within the range of what one might expect?” Dr. Schaechter said. “Were there other factors that might have come into play?”

The board performs an extensive analysis every year before releasing scores, and it didn’t uncover any changes in the difficulty or content of the test in 2021, nor did the score that was needed to pass increase. Dr. Schaechter pointed out that the passing rate that year was not unprecedented – in 2016, it also dipped to 81%.

Dr. Schaechter said COVID-19 might have affected test takers. “Remember, pediatrics was different from any other specialty during the pandemic,” she said. The census in pediatric wards around the country dropped dramatically in the first two winters of the pandemic, leaving residents with less hands-on experience with patients and mentorship from attendings – both of which can help test-takers pass the exam.

Eyal Ben-Isaac, MD, an associate professor of the department of pediatrics at the Keck School of Medicine at the University of Southern California, Los Angeles, said residents likely suffered during the pandemic, when noon lectures and grand rounds became virtual events.

“I’m sure that clearly affected a person’s ability to sit and listen and really learn the material, as opposed to either doing it hands on or learning the material from a faculty member face to face,” Dr. Ben-Isaac said.

But how much do the didactic experiences of residency programs contribute to residents’ readiness to take the boards? Thomas Welch, MD, professor and chair emeritus of the department of pediatrics at SUNY Upstate Medical University, Syracuse, credits his own success in advancing through college, medical school, pediatric residency, and nephrology fellowship to his skill as a test taker.

He confirmed his suspicions by conducting a study that evaluated correlations between residents’ performance on the United States Medical Licensing Exam (USMLE) taken during medical school and their board scores after completing residency.

Dr. Welch said he wasn’t surprised to find that “the best predictor of one’s passing the pediatric boards was not the training program in which one worked. It was their performance on Step 2 [taken during the fourth year of medical school] of the USMLE.”

Although Dr. Ben-Isaac felt that changes in residency training opportunities might have partially explained the drop in passing rates, he agreed that other factors contribute to success on boards. As director of the pediatric residency program at Children’s Hospital of Los Angeles from 1994 to 2019, one of his first goals was to increase the pass rate of graduates. He developed a board review course for residents, revising it over time on the basis of resident feedback and adding individual coaching for residents who wanted more help.

“Without a question, it raised our board pass rate to being one of the highest in the country,” he said.

Dr. Welch said that while “being up all night with a sick child teaches you a lot about medicine and certainly makes you a better doctor, it doesn’t do anything to improve your board scores.”

None of the pediatricians was too worried about a 1-year drop in scores, and the consensus was that supporting residents with review courses and coaching on how to take multiple choice tests would raise passing rates.

“There are definitely people who are amazing clinicians who did not pass the boards on their first attempt,” Dr. Ben-Isaac said.

But Dr. Schaechter defended the importance of the examination. “Our first obligation is really to the public,” she said. The ABP’s role is to ensure that pediatricians “provide the care that parents want their kids to have.”

As Dr. Welch put it, “Would I trust someone who didn’t pass the board exam to take care of my own kid? Probably not.”

A version of this article first appeared on Medscape.com.

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Few pediatricians have warm, fuzzy memories about taking their initial board exam.

But many reacted strongly when they read a recent post on Twitter by Bryan Carmody, MD, who noted that the passing rate for first-time test takers had dipped to its lowest level in 5 years – hitting 81% in 2021, down from 91% 3 years earlier.

“It’s literally an awfully written exam,” replied one person who posted. Another asked: “At what point is the exam just not reflective of clinical practice?” And, inevitably, the question of the effect of COVID-19 surfaced: “Is any of this attributable to pulling early career physicians into the pandemic?”

But Dr. Carmody, an associate professor of pediatrics at the University of Eastern Virginia Medical School, Norfolk, isn’t buying that explanation. He researched board scores for internal medicine, general surgery, and family medicine for 2021. All were stable during the same period, he said, leading him to dismiss the idea that the pandemic drove the decline. “It’s not really clear to me why other specialties wouldn’t have seen similar drops,” Dr. Carmody said.

The slip has caught the attention of the American Board of Pediatrics, according to Judy Schaechter, MD, MBA, who was chair of the department of pediatrics at the University of Miami before taking her post as president and CEO of the American Board of Pediatrics in 2021.

“So, our first question was, was this within the range of what one might expect?” Dr. Schaechter said. “Were there other factors that might have come into play?”

The board performs an extensive analysis every year before releasing scores, and it didn’t uncover any changes in the difficulty or content of the test in 2021, nor did the score that was needed to pass increase. Dr. Schaechter pointed out that the passing rate that year was not unprecedented – in 2016, it also dipped to 81%.

Dr. Schaechter said COVID-19 might have affected test takers. “Remember, pediatrics was different from any other specialty during the pandemic,” she said. The census in pediatric wards around the country dropped dramatically in the first two winters of the pandemic, leaving residents with less hands-on experience with patients and mentorship from attendings – both of which can help test-takers pass the exam.

Eyal Ben-Isaac, MD, an associate professor of the department of pediatrics at the Keck School of Medicine at the University of Southern California, Los Angeles, said residents likely suffered during the pandemic, when noon lectures and grand rounds became virtual events.

“I’m sure that clearly affected a person’s ability to sit and listen and really learn the material, as opposed to either doing it hands on or learning the material from a faculty member face to face,” Dr. Ben-Isaac said.

But how much do the didactic experiences of residency programs contribute to residents’ readiness to take the boards? Thomas Welch, MD, professor and chair emeritus of the department of pediatrics at SUNY Upstate Medical University, Syracuse, credits his own success in advancing through college, medical school, pediatric residency, and nephrology fellowship to his skill as a test taker.

He confirmed his suspicions by conducting a study that evaluated correlations between residents’ performance on the United States Medical Licensing Exam (USMLE) taken during medical school and their board scores after completing residency.

Dr. Welch said he wasn’t surprised to find that “the best predictor of one’s passing the pediatric boards was not the training program in which one worked. It was their performance on Step 2 [taken during the fourth year of medical school] of the USMLE.”

Although Dr. Ben-Isaac felt that changes in residency training opportunities might have partially explained the drop in passing rates, he agreed that other factors contribute to success on boards. As director of the pediatric residency program at Children’s Hospital of Los Angeles from 1994 to 2019, one of his first goals was to increase the pass rate of graduates. He developed a board review course for residents, revising it over time on the basis of resident feedback and adding individual coaching for residents who wanted more help.

“Without a question, it raised our board pass rate to being one of the highest in the country,” he said.

Dr. Welch said that while “being up all night with a sick child teaches you a lot about medicine and certainly makes you a better doctor, it doesn’t do anything to improve your board scores.”

None of the pediatricians was too worried about a 1-year drop in scores, and the consensus was that supporting residents with review courses and coaching on how to take multiple choice tests would raise passing rates.

“There are definitely people who are amazing clinicians who did not pass the boards on their first attempt,” Dr. Ben-Isaac said.

But Dr. Schaechter defended the importance of the examination. “Our first obligation is really to the public,” she said. The ABP’s role is to ensure that pediatricians “provide the care that parents want their kids to have.”

As Dr. Welch put it, “Would I trust someone who didn’t pass the board exam to take care of my own kid? Probably not.”

A version of this article first appeared on Medscape.com.

Few pediatricians have warm, fuzzy memories about taking their initial board exam.

But many reacted strongly when they read a recent post on Twitter by Bryan Carmody, MD, who noted that the passing rate for first-time test takers had dipped to its lowest level in 5 years – hitting 81% in 2021, down from 91% 3 years earlier.

“It’s literally an awfully written exam,” replied one person who posted. Another asked: “At what point is the exam just not reflective of clinical practice?” And, inevitably, the question of the effect of COVID-19 surfaced: “Is any of this attributable to pulling early career physicians into the pandemic?”

But Dr. Carmody, an associate professor of pediatrics at the University of Eastern Virginia Medical School, Norfolk, isn’t buying that explanation. He researched board scores for internal medicine, general surgery, and family medicine for 2021. All were stable during the same period, he said, leading him to dismiss the idea that the pandemic drove the decline. “It’s not really clear to me why other specialties wouldn’t have seen similar drops,” Dr. Carmody said.

The slip has caught the attention of the American Board of Pediatrics, according to Judy Schaechter, MD, MBA, who was chair of the department of pediatrics at the University of Miami before taking her post as president and CEO of the American Board of Pediatrics in 2021.

“So, our first question was, was this within the range of what one might expect?” Dr. Schaechter said. “Were there other factors that might have come into play?”

The board performs an extensive analysis every year before releasing scores, and it didn’t uncover any changes in the difficulty or content of the test in 2021, nor did the score that was needed to pass increase. Dr. Schaechter pointed out that the passing rate that year was not unprecedented – in 2016, it also dipped to 81%.

Dr. Schaechter said COVID-19 might have affected test takers. “Remember, pediatrics was different from any other specialty during the pandemic,” she said. The census in pediatric wards around the country dropped dramatically in the first two winters of the pandemic, leaving residents with less hands-on experience with patients and mentorship from attendings – both of which can help test-takers pass the exam.

Eyal Ben-Isaac, MD, an associate professor of the department of pediatrics at the Keck School of Medicine at the University of Southern California, Los Angeles, said residents likely suffered during the pandemic, when noon lectures and grand rounds became virtual events.

“I’m sure that clearly affected a person’s ability to sit and listen and really learn the material, as opposed to either doing it hands on or learning the material from a faculty member face to face,” Dr. Ben-Isaac said.

But how much do the didactic experiences of residency programs contribute to residents’ readiness to take the boards? Thomas Welch, MD, professor and chair emeritus of the department of pediatrics at SUNY Upstate Medical University, Syracuse, credits his own success in advancing through college, medical school, pediatric residency, and nephrology fellowship to his skill as a test taker.

He confirmed his suspicions by conducting a study that evaluated correlations between residents’ performance on the United States Medical Licensing Exam (USMLE) taken during medical school and their board scores after completing residency.

Dr. Welch said he wasn’t surprised to find that “the best predictor of one’s passing the pediatric boards was not the training program in which one worked. It was their performance on Step 2 [taken during the fourth year of medical school] of the USMLE.”

Although Dr. Ben-Isaac felt that changes in residency training opportunities might have partially explained the drop in passing rates, he agreed that other factors contribute to success on boards. As director of the pediatric residency program at Children’s Hospital of Los Angeles from 1994 to 2019, one of his first goals was to increase the pass rate of graduates. He developed a board review course for residents, revising it over time on the basis of resident feedback and adding individual coaching for residents who wanted more help.

“Without a question, it raised our board pass rate to being one of the highest in the country,” he said.

Dr. Welch said that while “being up all night with a sick child teaches you a lot about medicine and certainly makes you a better doctor, it doesn’t do anything to improve your board scores.”

None of the pediatricians was too worried about a 1-year drop in scores, and the consensus was that supporting residents with review courses and coaching on how to take multiple choice tests would raise passing rates.

“There are definitely people who are amazing clinicians who did not pass the boards on their first attempt,” Dr. Ben-Isaac said.

But Dr. Schaechter defended the importance of the examination. “Our first obligation is really to the public,” she said. The ABP’s role is to ensure that pediatricians “provide the care that parents want their kids to have.”

As Dr. Welch put it, “Would I trust someone who didn’t pass the board exam to take care of my own kid? Probably not.”

A version of this article first appeared on Medscape.com.

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A freak impalement by a model rocket has this doctor scrambling

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North central Washington state is a lot of nothing other than fields. Every year, the Federal Aviation Administration closes the airspace in a remote part of the area for a model rocket competition, the National Association of Rocketry Annual Meet. It’s a 2-day event and a pretty big deal. People come from all over the country to be there.

When you were a kid, you probably saw those rockets that are 3 feet tall. You launch them up in the air, they have a little parachute that comes out and they come back down to the ground. Well, picture that on ultimate steroids. There are anywhere from 3-foot to almost 20-foot-long rockets at this thing. People show up with horse trailers full of rockets and components. I mean, it’s an obsession.

Some of these rockets are super sophisticated. They have different stages where the first stage burns out and the second takes over. They go up thousands of feet to the edge of the stratosphere. Most of them have GoPro cameras, so you get to see when the rocket reaches the top of its trajectory and the last engine burns out. As it starts to descend, a parachute deploys and it can drift back anywhere from pretty close to where you launched it to a couple miles away. Then you use your little GPS to find it.

I have a nephew who worked for Boeing, and he and his son had a 6-foot entry in this competition. He invited me to come out and see it go off. Why not? I drove out there and parked my Jeep and was walking over to the competition when I noticed something off. A bigger commotion than there should have been.

Here’s what happened 2 minutes before I got there:

A 5-foot-long rocket, 2½ inches in diameter, had reached the top of its several thousand–foot trajectory and was ready to come back to Earth. But its parachute didn’t deploy. It turned itself point-down and literally shot back to earth like a rocket.

It had gone up pretty darn straight and came down just as straight – right into a circle of people sitting in lawn chairs.

It hit a middle-aged man. But you can’t imagine how. First of all, who knows how fast it was going. The point glanced off his forehead and ... how to describe the rest. The man was pretty heavy. So the rocket impaled him through the abdomen and stuck right into the ground. As in, the point entered the top of his belly just below chest level and came out the bottom of his belly. The rocket pinned him to the ground through his belly.

Well, this was not how I planned on spending my day. But my spectator time was over. There were a lot of people running around in circles where he was pinned, not really knowing what to do.

When I said I was an emergency physician, instantly 15 heads looked right at me for direction like, Oh my gosh, please take over! A lot of people were asking: “What can I do? What can I do?” I said: “Well, we don’t need to do CPR. What we really need to do is get this rocket out of the ground. We need to keep him still while we dig out the rocket and get him flat.”

People gently dug around the nose of the rocket. It was in about 6 or 8 inches, enough that we didn’t want to just yank on it (I still marvel at how fast it must have been traveling to both impale the man the way it did and also jam into the ground like that). We wanted to loosen it up and ease it out of the ground.

We managed to dig the nose out and get the guy on his back. Needless to say, he wasn’t particularly comfortable. He looked pretty ashen, like he was in pretty good trouble.

The festival had an EMS kit with some bandages in it, but not a whole lot else. There’s the old joke in emergency medicine: What can you do with duct tape, a Swiss army knife, and a paper clip? It’s like, what has anybody got that might work here?

What we really needed to do was keep both the rocket and the man from moving. We cut off his shirt and got his pants down so that I could better see where it entered and exited. Then we used a couple of clean T-shirts to stabilize the rocket so it didn’t move while he lay flat. It didn’t bleed all that much. And his belly wasn’t massively expanding like he was bleeding internally. I mean, he looked crappy. But so would I!

We were about an hour away from the closest EMS and only a couple people even had cell service out there. But we managed to get hold of EMS. It was also one of those 92-degree days with no shade for 50 miles in any direction.

There was a volunteer firefighter there to man the fire rig. He helped carry the guy into an air-conditioned trailer without moving him very much.

Basically, we stabilized him by keeping him super still and as comfortable as we could until EMS arrived. I rode with him about an hour and a half to the closest trauma center in Central Washington. He was conscious, which was lousy for him but reassuring for me. “You’re still talking to me,” I said. “I think you’re going to be okay.”

One of the take-home points from a medical point of view is never try to remove something sticking out of someone when you’re out in the field. If it’s pushing against something vital, you could do a lot of damage, and if it’s up against a blood vessel, that vessel’s going to bleed uncontrollably.

We got to the trauma center and they took him to the OR. By the grace of friendships, somebody got his wife to the hospital. She was calmer than I think I would have been if my spouse had been hit by a rocket.

The full diagnostic story: The rocket bouncing off his forehead gave him a small skull fracture and slight concussion. That was no big deal. But picture this: The rocket only went through his belly fat. It didn’t hit any of his abdominal organs! I still think this is absolutely amazing. If he had been leaning forward in his lawn chair even a few inches, the rocket would’ve gone through his head and that would’ve been all they wrote.

He stayed in the hospital for a couple of days. I never saw him again, but I received follow-up from the surgeon. And I read the paper the next day. Let me tell you, in Central Washington, this is pretty big news.

It wasn’t the way I’d planned my morning. But you just can’t predict that kind of thing. I don’t know, maybe spiritually or karma wise, I was meant to show up about 90 seconds after he’d been hit. The only emergency physician at the whole event, just by chance. My work blesses me with a certain skill set. I know when to really worry, how to go about keeping somebody safe until you can get them to the ED. It’s something I thank my stars for every single day.

As I said to the guy on the way to the hospital: “Well, it’s not your lucky day, but it sure as heck could have been a whole lot unluckier.”

Stephen Anderson, MD, is an emergency medicine physician in Auburn, Washington and is affiliated with MultiCare Auburn Medical Center.

A version of this article first appeared on Medscape.com.

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North central Washington state is a lot of nothing other than fields. Every year, the Federal Aviation Administration closes the airspace in a remote part of the area for a model rocket competition, the National Association of Rocketry Annual Meet. It’s a 2-day event and a pretty big deal. People come from all over the country to be there.

When you were a kid, you probably saw those rockets that are 3 feet tall. You launch them up in the air, they have a little parachute that comes out and they come back down to the ground. Well, picture that on ultimate steroids. There are anywhere from 3-foot to almost 20-foot-long rockets at this thing. People show up with horse trailers full of rockets and components. I mean, it’s an obsession.

Some of these rockets are super sophisticated. They have different stages where the first stage burns out and the second takes over. They go up thousands of feet to the edge of the stratosphere. Most of them have GoPro cameras, so you get to see when the rocket reaches the top of its trajectory and the last engine burns out. As it starts to descend, a parachute deploys and it can drift back anywhere from pretty close to where you launched it to a couple miles away. Then you use your little GPS to find it.

I have a nephew who worked for Boeing, and he and his son had a 6-foot entry in this competition. He invited me to come out and see it go off. Why not? I drove out there and parked my Jeep and was walking over to the competition when I noticed something off. A bigger commotion than there should have been.

Here’s what happened 2 minutes before I got there:

A 5-foot-long rocket, 2½ inches in diameter, had reached the top of its several thousand–foot trajectory and was ready to come back to Earth. But its parachute didn’t deploy. It turned itself point-down and literally shot back to earth like a rocket.

It had gone up pretty darn straight and came down just as straight – right into a circle of people sitting in lawn chairs.

It hit a middle-aged man. But you can’t imagine how. First of all, who knows how fast it was going. The point glanced off his forehead and ... how to describe the rest. The man was pretty heavy. So the rocket impaled him through the abdomen and stuck right into the ground. As in, the point entered the top of his belly just below chest level and came out the bottom of his belly. The rocket pinned him to the ground through his belly.

Well, this was not how I planned on spending my day. But my spectator time was over. There were a lot of people running around in circles where he was pinned, not really knowing what to do.

When I said I was an emergency physician, instantly 15 heads looked right at me for direction like, Oh my gosh, please take over! A lot of people were asking: “What can I do? What can I do?” I said: “Well, we don’t need to do CPR. What we really need to do is get this rocket out of the ground. We need to keep him still while we dig out the rocket and get him flat.”

People gently dug around the nose of the rocket. It was in about 6 or 8 inches, enough that we didn’t want to just yank on it (I still marvel at how fast it must have been traveling to both impale the man the way it did and also jam into the ground like that). We wanted to loosen it up and ease it out of the ground.

We managed to dig the nose out and get the guy on his back. Needless to say, he wasn’t particularly comfortable. He looked pretty ashen, like he was in pretty good trouble.

The festival had an EMS kit with some bandages in it, but not a whole lot else. There’s the old joke in emergency medicine: What can you do with duct tape, a Swiss army knife, and a paper clip? It’s like, what has anybody got that might work here?

What we really needed to do was keep both the rocket and the man from moving. We cut off his shirt and got his pants down so that I could better see where it entered and exited. Then we used a couple of clean T-shirts to stabilize the rocket so it didn’t move while he lay flat. It didn’t bleed all that much. And his belly wasn’t massively expanding like he was bleeding internally. I mean, he looked crappy. But so would I!

We were about an hour away from the closest EMS and only a couple people even had cell service out there. But we managed to get hold of EMS. It was also one of those 92-degree days with no shade for 50 miles in any direction.

There was a volunteer firefighter there to man the fire rig. He helped carry the guy into an air-conditioned trailer without moving him very much.

Basically, we stabilized him by keeping him super still and as comfortable as we could until EMS arrived. I rode with him about an hour and a half to the closest trauma center in Central Washington. He was conscious, which was lousy for him but reassuring for me. “You’re still talking to me,” I said. “I think you’re going to be okay.”

One of the take-home points from a medical point of view is never try to remove something sticking out of someone when you’re out in the field. If it’s pushing against something vital, you could do a lot of damage, and if it’s up against a blood vessel, that vessel’s going to bleed uncontrollably.

We got to the trauma center and they took him to the OR. By the grace of friendships, somebody got his wife to the hospital. She was calmer than I think I would have been if my spouse had been hit by a rocket.

The full diagnostic story: The rocket bouncing off his forehead gave him a small skull fracture and slight concussion. That was no big deal. But picture this: The rocket only went through his belly fat. It didn’t hit any of his abdominal organs! I still think this is absolutely amazing. If he had been leaning forward in his lawn chair even a few inches, the rocket would’ve gone through his head and that would’ve been all they wrote.

He stayed in the hospital for a couple of days. I never saw him again, but I received follow-up from the surgeon. And I read the paper the next day. Let me tell you, in Central Washington, this is pretty big news.

It wasn’t the way I’d planned my morning. But you just can’t predict that kind of thing. I don’t know, maybe spiritually or karma wise, I was meant to show up about 90 seconds after he’d been hit. The only emergency physician at the whole event, just by chance. My work blesses me with a certain skill set. I know when to really worry, how to go about keeping somebody safe until you can get them to the ED. It’s something I thank my stars for every single day.

As I said to the guy on the way to the hospital: “Well, it’s not your lucky day, but it sure as heck could have been a whole lot unluckier.”

Stephen Anderson, MD, is an emergency medicine physician in Auburn, Washington and is affiliated with MultiCare Auburn Medical Center.

A version of this article first appeared on Medscape.com.

North central Washington state is a lot of nothing other than fields. Every year, the Federal Aviation Administration closes the airspace in a remote part of the area for a model rocket competition, the National Association of Rocketry Annual Meet. It’s a 2-day event and a pretty big deal. People come from all over the country to be there.

When you were a kid, you probably saw those rockets that are 3 feet tall. You launch them up in the air, they have a little parachute that comes out and they come back down to the ground. Well, picture that on ultimate steroids. There are anywhere from 3-foot to almost 20-foot-long rockets at this thing. People show up with horse trailers full of rockets and components. I mean, it’s an obsession.

Some of these rockets are super sophisticated. They have different stages where the first stage burns out and the second takes over. They go up thousands of feet to the edge of the stratosphere. Most of them have GoPro cameras, so you get to see when the rocket reaches the top of its trajectory and the last engine burns out. As it starts to descend, a parachute deploys and it can drift back anywhere from pretty close to where you launched it to a couple miles away. Then you use your little GPS to find it.

I have a nephew who worked for Boeing, and he and his son had a 6-foot entry in this competition. He invited me to come out and see it go off. Why not? I drove out there and parked my Jeep and was walking over to the competition when I noticed something off. A bigger commotion than there should have been.

Here’s what happened 2 minutes before I got there:

A 5-foot-long rocket, 2½ inches in diameter, had reached the top of its several thousand–foot trajectory and was ready to come back to Earth. But its parachute didn’t deploy. It turned itself point-down and literally shot back to earth like a rocket.

It had gone up pretty darn straight and came down just as straight – right into a circle of people sitting in lawn chairs.

It hit a middle-aged man. But you can’t imagine how. First of all, who knows how fast it was going. The point glanced off his forehead and ... how to describe the rest. The man was pretty heavy. So the rocket impaled him through the abdomen and stuck right into the ground. As in, the point entered the top of his belly just below chest level and came out the bottom of his belly. The rocket pinned him to the ground through his belly.

Well, this was not how I planned on spending my day. But my spectator time was over. There were a lot of people running around in circles where he was pinned, not really knowing what to do.

When I said I was an emergency physician, instantly 15 heads looked right at me for direction like, Oh my gosh, please take over! A lot of people were asking: “What can I do? What can I do?” I said: “Well, we don’t need to do CPR. What we really need to do is get this rocket out of the ground. We need to keep him still while we dig out the rocket and get him flat.”

People gently dug around the nose of the rocket. It was in about 6 or 8 inches, enough that we didn’t want to just yank on it (I still marvel at how fast it must have been traveling to both impale the man the way it did and also jam into the ground like that). We wanted to loosen it up and ease it out of the ground.

We managed to dig the nose out and get the guy on his back. Needless to say, he wasn’t particularly comfortable. He looked pretty ashen, like he was in pretty good trouble.

The festival had an EMS kit with some bandages in it, but not a whole lot else. There’s the old joke in emergency medicine: What can you do with duct tape, a Swiss army knife, and a paper clip? It’s like, what has anybody got that might work here?

What we really needed to do was keep both the rocket and the man from moving. We cut off his shirt and got his pants down so that I could better see where it entered and exited. Then we used a couple of clean T-shirts to stabilize the rocket so it didn’t move while he lay flat. It didn’t bleed all that much. And his belly wasn’t massively expanding like he was bleeding internally. I mean, he looked crappy. But so would I!

We were about an hour away from the closest EMS and only a couple people even had cell service out there. But we managed to get hold of EMS. It was also one of those 92-degree days with no shade for 50 miles in any direction.

There was a volunteer firefighter there to man the fire rig. He helped carry the guy into an air-conditioned trailer without moving him very much.

Basically, we stabilized him by keeping him super still and as comfortable as we could until EMS arrived. I rode with him about an hour and a half to the closest trauma center in Central Washington. He was conscious, which was lousy for him but reassuring for me. “You’re still talking to me,” I said. “I think you’re going to be okay.”

One of the take-home points from a medical point of view is never try to remove something sticking out of someone when you’re out in the field. If it’s pushing against something vital, you could do a lot of damage, and if it’s up against a blood vessel, that vessel’s going to bleed uncontrollably.

We got to the trauma center and they took him to the OR. By the grace of friendships, somebody got his wife to the hospital. She was calmer than I think I would have been if my spouse had been hit by a rocket.

The full diagnostic story: The rocket bouncing off his forehead gave him a small skull fracture and slight concussion. That was no big deal. But picture this: The rocket only went through his belly fat. It didn’t hit any of his abdominal organs! I still think this is absolutely amazing. If he had been leaning forward in his lawn chair even a few inches, the rocket would’ve gone through his head and that would’ve been all they wrote.

He stayed in the hospital for a couple of days. I never saw him again, but I received follow-up from the surgeon. And I read the paper the next day. Let me tell you, in Central Washington, this is pretty big news.

It wasn’t the way I’d planned my morning. But you just can’t predict that kind of thing. I don’t know, maybe spiritually or karma wise, I was meant to show up about 90 seconds after he’d been hit. The only emergency physician at the whole event, just by chance. My work blesses me with a certain skill set. I know when to really worry, how to go about keeping somebody safe until you can get them to the ED. It’s something I thank my stars for every single day.

As I said to the guy on the way to the hospital: “Well, it’s not your lucky day, but it sure as heck could have been a whole lot unluckier.”

Stephen Anderson, MD, is an emergency medicine physician in Auburn, Washington and is affiliated with MultiCare Auburn Medical Center.

A version of this article first appeared on Medscape.com.

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U.S. ketamine poisonings up 81%

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Ketamine poisonings in the United States increased 81% between 2019 and 2021, according to a new analysis of calls to poison control centers.

Although the overall ketamine exposures were low, researchers say the findings add to a growing body of research that suggests recreational ketamine use may be on the rise.

“Ketamine is by no means the most dangerous drug, but it could be dangerous if combined with drugs such as alcohol or if used in potentially hazardous situations – physically hazardous or socially hazardous,” lead author Joseph Palamar, PhD, associate professor and epidemiologist at New York University Langone Health, New York, told this news organization.

“People who decide to use ketamine recreationally need to be educated about potential risks,” Dr. Palamar said.

The findings were recently published online in the Journal of Psychopharmacology.
 

More widespread use

Researchers noted that ketamine use has become more widespread in the United States due in part to increasing availability of ketamine in both clinical and nonclinical settings.

Previous work by Dr. Palamar documented an increase in recreational use of ketamine at dance clubs and an increase in ketamine seizures by the Drug Enforcement Administration.

In the current study, investigators analyzed data from the National Poison Control database and included cases reported by 51 of the 55 poison control centers in the United States.

They identified 758 cases involving ketamine exposure between the first quarter of 2019 and the last quarter of 2021 in individuals aged 13 and older, more than half of whom were men.

The number of ketamine exposures increased 81.1% during the study period, rising from 37 to 67 (P = .018).

Nearly 40% of callers reported intentional misuse or abuse of ketamine, while 19.7% involved a suspected suicide or suicide attempt. The ketamine exposure was unintended in 18.9% of cases, and 10.6% of calls involved an adverse drug reaction.

Onep-third of cases involved co-use of other substances, most commonly benzodiazepines, opioids, or alcohol.

The route of administration was ingestion for 44.3%, injection for 18.8%, and inhalation for 17.6%. Another 19.3% involved another route or a combination of routes.

Nearly 20% of cases reported a major adverse effect or death, 42.8% reported a moderate effect, 25.8% a minor effect, and 11.8% no effect. There were seven deaths reported in ketamine-related calls, although Dr. Palamar noted it is unlikely those deaths were due solely to ketamine use.

Researchers didn’t analyze specific harms reported in the calls, but chronic and heavy ketamine use has been previously associated with cognitive impairment, urinary cystitis and other urinary tract issues, and upper gastrointestinal problems.

In addition, using ketamine with gamma-hydroxybutyrate (GHB) or opioids was associated with a significantly higher risk for major adverse effects (P < .001 for both). Injecting ketamine was also linked to a higher prevalence of major adverse effects, although the association did not quite reach significance (P < .05).
 

Cause for concern

Commenting on the findings, Timothy Wiegand, MD, director of Addiction Toxicology and Toxicology Consult Service and associate professor of emergency medicine at the University of Rochester Medical Center and Strong Memorial Hospital, New York, noted the data on co-use of ketamine with other drugs were cause for concern.

“I think the co-occurring behaviors are critical here with concomitant use of opioids and GHB, intravenous drug use, or that it is used in an attempt to harm one’s self because it allows for identification of these behaviors or use patterns,” said Dr. Wiegand, who was not involved with the research.

He added that it is important for “addiction providers and others in medicine or in the addiction field to be aware of trends” associated with ketamine.

“At the same time, a focus on general prevention, and access to care and treatment, and understanding how to implement harm reduction strategies remain high priorities,” Dr. Wiegand said.

The study was funded by the National Institute on Drug Abuse. Dr. Palamar has reported consulting for Alkermes. Dr. Wiegand has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Ketamine poisonings in the United States increased 81% between 2019 and 2021, according to a new analysis of calls to poison control centers.

Although the overall ketamine exposures were low, researchers say the findings add to a growing body of research that suggests recreational ketamine use may be on the rise.

“Ketamine is by no means the most dangerous drug, but it could be dangerous if combined with drugs such as alcohol or if used in potentially hazardous situations – physically hazardous or socially hazardous,” lead author Joseph Palamar, PhD, associate professor and epidemiologist at New York University Langone Health, New York, told this news organization.

“People who decide to use ketamine recreationally need to be educated about potential risks,” Dr. Palamar said.

The findings were recently published online in the Journal of Psychopharmacology.
 

More widespread use

Researchers noted that ketamine use has become more widespread in the United States due in part to increasing availability of ketamine in both clinical and nonclinical settings.

Previous work by Dr. Palamar documented an increase in recreational use of ketamine at dance clubs and an increase in ketamine seizures by the Drug Enforcement Administration.

In the current study, investigators analyzed data from the National Poison Control database and included cases reported by 51 of the 55 poison control centers in the United States.

They identified 758 cases involving ketamine exposure between the first quarter of 2019 and the last quarter of 2021 in individuals aged 13 and older, more than half of whom were men.

The number of ketamine exposures increased 81.1% during the study period, rising from 37 to 67 (P = .018).

Nearly 40% of callers reported intentional misuse or abuse of ketamine, while 19.7% involved a suspected suicide or suicide attempt. The ketamine exposure was unintended in 18.9% of cases, and 10.6% of calls involved an adverse drug reaction.

Onep-third of cases involved co-use of other substances, most commonly benzodiazepines, opioids, or alcohol.

The route of administration was ingestion for 44.3%, injection for 18.8%, and inhalation for 17.6%. Another 19.3% involved another route or a combination of routes.

Nearly 20% of cases reported a major adverse effect or death, 42.8% reported a moderate effect, 25.8% a minor effect, and 11.8% no effect. There were seven deaths reported in ketamine-related calls, although Dr. Palamar noted it is unlikely those deaths were due solely to ketamine use.

Researchers didn’t analyze specific harms reported in the calls, but chronic and heavy ketamine use has been previously associated with cognitive impairment, urinary cystitis and other urinary tract issues, and upper gastrointestinal problems.

In addition, using ketamine with gamma-hydroxybutyrate (GHB) or opioids was associated with a significantly higher risk for major adverse effects (P < .001 for both). Injecting ketamine was also linked to a higher prevalence of major adverse effects, although the association did not quite reach significance (P < .05).
 

Cause for concern

Commenting on the findings, Timothy Wiegand, MD, director of Addiction Toxicology and Toxicology Consult Service and associate professor of emergency medicine at the University of Rochester Medical Center and Strong Memorial Hospital, New York, noted the data on co-use of ketamine with other drugs were cause for concern.

“I think the co-occurring behaviors are critical here with concomitant use of opioids and GHB, intravenous drug use, or that it is used in an attempt to harm one’s self because it allows for identification of these behaviors or use patterns,” said Dr. Wiegand, who was not involved with the research.

He added that it is important for “addiction providers and others in medicine or in the addiction field to be aware of trends” associated with ketamine.

“At the same time, a focus on general prevention, and access to care and treatment, and understanding how to implement harm reduction strategies remain high priorities,” Dr. Wiegand said.

The study was funded by the National Institute on Drug Abuse. Dr. Palamar has reported consulting for Alkermes. Dr. Wiegand has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Ketamine poisonings in the United States increased 81% between 2019 and 2021, according to a new analysis of calls to poison control centers.

Although the overall ketamine exposures were low, researchers say the findings add to a growing body of research that suggests recreational ketamine use may be on the rise.

“Ketamine is by no means the most dangerous drug, but it could be dangerous if combined with drugs such as alcohol or if used in potentially hazardous situations – physically hazardous or socially hazardous,” lead author Joseph Palamar, PhD, associate professor and epidemiologist at New York University Langone Health, New York, told this news organization.

“People who decide to use ketamine recreationally need to be educated about potential risks,” Dr. Palamar said.

The findings were recently published online in the Journal of Psychopharmacology.
 

More widespread use

Researchers noted that ketamine use has become more widespread in the United States due in part to increasing availability of ketamine in both clinical and nonclinical settings.

Previous work by Dr. Palamar documented an increase in recreational use of ketamine at dance clubs and an increase in ketamine seizures by the Drug Enforcement Administration.

In the current study, investigators analyzed data from the National Poison Control database and included cases reported by 51 of the 55 poison control centers in the United States.

They identified 758 cases involving ketamine exposure between the first quarter of 2019 and the last quarter of 2021 in individuals aged 13 and older, more than half of whom were men.

The number of ketamine exposures increased 81.1% during the study period, rising from 37 to 67 (P = .018).

Nearly 40% of callers reported intentional misuse or abuse of ketamine, while 19.7% involved a suspected suicide or suicide attempt. The ketamine exposure was unintended in 18.9% of cases, and 10.6% of calls involved an adverse drug reaction.

Onep-third of cases involved co-use of other substances, most commonly benzodiazepines, opioids, or alcohol.

The route of administration was ingestion for 44.3%, injection for 18.8%, and inhalation for 17.6%. Another 19.3% involved another route or a combination of routes.

Nearly 20% of cases reported a major adverse effect or death, 42.8% reported a moderate effect, 25.8% a minor effect, and 11.8% no effect. There were seven deaths reported in ketamine-related calls, although Dr. Palamar noted it is unlikely those deaths were due solely to ketamine use.

Researchers didn’t analyze specific harms reported in the calls, but chronic and heavy ketamine use has been previously associated with cognitive impairment, urinary cystitis and other urinary tract issues, and upper gastrointestinal problems.

In addition, using ketamine with gamma-hydroxybutyrate (GHB) or opioids was associated with a significantly higher risk for major adverse effects (P < .001 for both). Injecting ketamine was also linked to a higher prevalence of major adverse effects, although the association did not quite reach significance (P < .05).
 

Cause for concern

Commenting on the findings, Timothy Wiegand, MD, director of Addiction Toxicology and Toxicology Consult Service and associate professor of emergency medicine at the University of Rochester Medical Center and Strong Memorial Hospital, New York, noted the data on co-use of ketamine with other drugs were cause for concern.

“I think the co-occurring behaviors are critical here with concomitant use of opioids and GHB, intravenous drug use, or that it is used in an attempt to harm one’s self because it allows for identification of these behaviors or use patterns,” said Dr. Wiegand, who was not involved with the research.

He added that it is important for “addiction providers and others in medicine or in the addiction field to be aware of trends” associated with ketamine.

“At the same time, a focus on general prevention, and access to care and treatment, and understanding how to implement harm reduction strategies remain high priorities,” Dr. Wiegand said.

The study was funded by the National Institute on Drug Abuse. Dr. Palamar has reported consulting for Alkermes. Dr. Wiegand has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

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Age-related atopic dermatitis phenotypes evaluated in study

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Pediatric patients with atopic dermatitis (AD) are more likely to experience symptoms at classical sites such as the knees and have more associated and severe signs of AD, while older adults tend to present with less flexural eczema and the fewest associated signs.

Those are key findings from a study conducted at a single academic medical center, which aimed to identify the age-related clinical phenotypes of AD.

LucaLorenzelli/Thinkstock

“Previous studies have found differences in the clinical characteristics of AD depending on age of AD onset, ethnic background, and AD severity,” senior author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the department of dermatology at George Washington University, Washington, and his coauthor wrote in the study, which was published online in JAAD International. “However, none have prospectively compared the clinical characteristics and associated signs by age group. Improved understanding of the clinical phenotypes of AD may help guide choice of treatment and improve health outcomes,” they added.

Along with coauthor Sheena Chatrath, a dermatology research fellow in the department, Dr. Silverberg prospectively reviewed self-reported questionnaires that were completed by 380 patients prior to their visit at GWU’s eczema clinic between 2013 and 2019. Questions included age of AD onset, sociodemographics, Visual Analog Scale (VAS) itch and sleep for Scoring AD, and Numeric Rating Scale (NRS) for skin pain and itch. The researchers used the Eczema Area Severity Index to assess AD severity and a dermatologist conducted full body skin exams, noting the distribution of AD involvement as well as associated signs.

Of the 380 patients, 6.1% were younger than aged 18 years, 46.3% were young adults aged 18-39 years, and 47.6% were older adults 40 years of age and older.

Dr. Jonathan I. Silverberg

Compared with pediatric patients, both young and older adults were less likely to experience AD on the ankles (adjusted odds ratio [aOR], 0.41 and 0.43, respectively), moderate to severe AD lesions on flexures (aOR, 0.47 and 0.30), pityriasis alba (aOR, 0.24 and 0.07), oozing lesions (aOR, 0.44 and 0.35), and moderate to severe excoriations (aOR, 0.49 and 0.44).

In children, severe itch was more common, reported in 47.1%, compared with 43.4% of the young adults and 38.6% of the older adults, and itch was less severe among the young and older adults. “Interestingly, despite increased itch in pediatric patients, we found no difference in the severity of skin pain across all age groups,” the researchers wrote. “Moreover, pediatric patients reported skin pain less often than adult patients. This may be due to age-related differences of pain perception.”

In other findings, compared with pediatric patients, young adults were more likely to experience AD around the eyes (aOR, 2.92), while older adults were less likely to experience AD on elbows (aOR, 0.34), nipples (aOR, 0.40), knees (aOR, 0.27), and less likely to have keratosis pilaris (aOR, 0.38), and lichenification (aOR, 0.47).

Dr. Silverberg and Ms. Chatrath used latent class analysis to identify four classes for distribution of AD lesions. In this model, class 1 had low probabilities of AD involvement at all sites examined and class 2 had low probabilities of scalp, face, and foot involvement, and intermediate probability of all other AD sites. Class 3 had low probabilities of hand and foot involvement, high probability of facial erythema, and intermediate probability of all other AD signs, while class 4 had intermediate probability of postauricular and foot involvement, and high probability of all other AD sites examined.



“Pediatric patients were most commonly in class 4 (33.3%), followed by class 1 and 2 (26.7%), and least commonly in class 3 (13.3%),” the authors wrote. “In young adults, class 4 and 1 were most common (32.4% and 29.4%), followed by class 2 (27.9%), and least commonly class 3 (10.3%). In older adults, class 1 was most common (40.3%), followed by class 4 (23.6%), and least commonly classes 2 and 3 (18.1%).”

The researchers also used latent class analysis to identify four classes for the signs and symptoms of AD. In this model, class 1 had zero-low probability of all AD signs and class 2 had low probability of all AD signs. Class 3 had high probability of oozing lesions and low probability of all other signs, while class 4 had high probability of xerosis, intermediate probability of ichthyosis and palmar hyperlinearity, and low probability of all other AD signs.

In all three groups, the most common class was class 1 (85.6% of older adults, 81.8% of younger adults, and 82.6% of pediatric patients). Among the pediatric patients, they wrote, “class 3 was the second most common (8.7%), followed by class 2 and 4 (4.4%).” Among the young adults, 9.7% were in class 2, 5.7% were in class 4, and 2.8% were in class 3; and among the older adults, 8.3% were in class 4, 4.4% were in class 2, and 1.67% were in class 3.

Zelma Chiesa Fuxench, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study, said that while AD is traditionally largely thought of as a disease of children primarily involving the flexural areas, “this study provides additional evidence to support that AD is more than just a disease of childhood with a fixed clinical presentation, but is a heterogeneous disease whose clinical presentation varies across different population groups.”

Dr. Zelma Chiesa Fuxench


While the study provides insight into the clinical differences that may be observed across AD groups, “care must be taken when interpreting these results as the study was done in a single center with observations collected during one single visit,” she added. “AD is not a ‘static’ disease; its presentation can stay the same in one patient but can vary even in another patient throughout their lifetime. Therefore, studies of a more prospective nature that evaluate the change in clinical presentation using multiple measures throughout time in these individuals would be a step forward to better understand if these phenotypic differences truly exist and, as such, what implications could they have for treatment selection.”

This study was supported by grants from the Agency for Healthcare Research and Quality and the Dermatology Foundation. The researchers reported having no disclosures. Dr. Chiesa Fuxench disclosed serving as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, Pfizer, AbbVie, and Incyte, for which she has received honoraria for AD-related work. She is the recipient of research grants through Regeneron, Sanofi, Tioga, Vanda, Menlo Therapeutics, Leo Pharma, and Eli Lilly for work related to AD as well as honoraria for continuing medical education work related to AD sponsored through educational grants from Regeneron/Sanofi and Pfizer.
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Pediatric patients with atopic dermatitis (AD) are more likely to experience symptoms at classical sites such as the knees and have more associated and severe signs of AD, while older adults tend to present with less flexural eczema and the fewest associated signs.

Those are key findings from a study conducted at a single academic medical center, which aimed to identify the age-related clinical phenotypes of AD.

LucaLorenzelli/Thinkstock

“Previous studies have found differences in the clinical characteristics of AD depending on age of AD onset, ethnic background, and AD severity,” senior author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the department of dermatology at George Washington University, Washington, and his coauthor wrote in the study, which was published online in JAAD International. “However, none have prospectively compared the clinical characteristics and associated signs by age group. Improved understanding of the clinical phenotypes of AD may help guide choice of treatment and improve health outcomes,” they added.

Along with coauthor Sheena Chatrath, a dermatology research fellow in the department, Dr. Silverberg prospectively reviewed self-reported questionnaires that were completed by 380 patients prior to their visit at GWU’s eczema clinic between 2013 and 2019. Questions included age of AD onset, sociodemographics, Visual Analog Scale (VAS) itch and sleep for Scoring AD, and Numeric Rating Scale (NRS) for skin pain and itch. The researchers used the Eczema Area Severity Index to assess AD severity and a dermatologist conducted full body skin exams, noting the distribution of AD involvement as well as associated signs.

Of the 380 patients, 6.1% were younger than aged 18 years, 46.3% were young adults aged 18-39 years, and 47.6% were older adults 40 years of age and older.

Dr. Jonathan I. Silverberg

Compared with pediatric patients, both young and older adults were less likely to experience AD on the ankles (adjusted odds ratio [aOR], 0.41 and 0.43, respectively), moderate to severe AD lesions on flexures (aOR, 0.47 and 0.30), pityriasis alba (aOR, 0.24 and 0.07), oozing lesions (aOR, 0.44 and 0.35), and moderate to severe excoriations (aOR, 0.49 and 0.44).

In children, severe itch was more common, reported in 47.1%, compared with 43.4% of the young adults and 38.6% of the older adults, and itch was less severe among the young and older adults. “Interestingly, despite increased itch in pediatric patients, we found no difference in the severity of skin pain across all age groups,” the researchers wrote. “Moreover, pediatric patients reported skin pain less often than adult patients. This may be due to age-related differences of pain perception.”

In other findings, compared with pediatric patients, young adults were more likely to experience AD around the eyes (aOR, 2.92), while older adults were less likely to experience AD on elbows (aOR, 0.34), nipples (aOR, 0.40), knees (aOR, 0.27), and less likely to have keratosis pilaris (aOR, 0.38), and lichenification (aOR, 0.47).

Dr. Silverberg and Ms. Chatrath used latent class analysis to identify four classes for distribution of AD lesions. In this model, class 1 had low probabilities of AD involvement at all sites examined and class 2 had low probabilities of scalp, face, and foot involvement, and intermediate probability of all other AD sites. Class 3 had low probabilities of hand and foot involvement, high probability of facial erythema, and intermediate probability of all other AD signs, while class 4 had intermediate probability of postauricular and foot involvement, and high probability of all other AD sites examined.



“Pediatric patients were most commonly in class 4 (33.3%), followed by class 1 and 2 (26.7%), and least commonly in class 3 (13.3%),” the authors wrote. “In young adults, class 4 and 1 were most common (32.4% and 29.4%), followed by class 2 (27.9%), and least commonly class 3 (10.3%). In older adults, class 1 was most common (40.3%), followed by class 4 (23.6%), and least commonly classes 2 and 3 (18.1%).”

The researchers also used latent class analysis to identify four classes for the signs and symptoms of AD. In this model, class 1 had zero-low probability of all AD signs and class 2 had low probability of all AD signs. Class 3 had high probability of oozing lesions and low probability of all other signs, while class 4 had high probability of xerosis, intermediate probability of ichthyosis and palmar hyperlinearity, and low probability of all other AD signs.

In all three groups, the most common class was class 1 (85.6% of older adults, 81.8% of younger adults, and 82.6% of pediatric patients). Among the pediatric patients, they wrote, “class 3 was the second most common (8.7%), followed by class 2 and 4 (4.4%).” Among the young adults, 9.7% were in class 2, 5.7% were in class 4, and 2.8% were in class 3; and among the older adults, 8.3% were in class 4, 4.4% were in class 2, and 1.67% were in class 3.

Zelma Chiesa Fuxench, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study, said that while AD is traditionally largely thought of as a disease of children primarily involving the flexural areas, “this study provides additional evidence to support that AD is more than just a disease of childhood with a fixed clinical presentation, but is a heterogeneous disease whose clinical presentation varies across different population groups.”

Dr. Zelma Chiesa Fuxench


While the study provides insight into the clinical differences that may be observed across AD groups, “care must be taken when interpreting these results as the study was done in a single center with observations collected during one single visit,” she added. “AD is not a ‘static’ disease; its presentation can stay the same in one patient but can vary even in another patient throughout their lifetime. Therefore, studies of a more prospective nature that evaluate the change in clinical presentation using multiple measures throughout time in these individuals would be a step forward to better understand if these phenotypic differences truly exist and, as such, what implications could they have for treatment selection.”

This study was supported by grants from the Agency for Healthcare Research and Quality and the Dermatology Foundation. The researchers reported having no disclosures. Dr. Chiesa Fuxench disclosed serving as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, Pfizer, AbbVie, and Incyte, for which she has received honoraria for AD-related work. She is the recipient of research grants through Regeneron, Sanofi, Tioga, Vanda, Menlo Therapeutics, Leo Pharma, and Eli Lilly for work related to AD as well as honoraria for continuing medical education work related to AD sponsored through educational grants from Regeneron/Sanofi and Pfizer.

Pediatric patients with atopic dermatitis (AD) are more likely to experience symptoms at classical sites such as the knees and have more associated and severe signs of AD, while older adults tend to present with less flexural eczema and the fewest associated signs.

Those are key findings from a study conducted at a single academic medical center, which aimed to identify the age-related clinical phenotypes of AD.

LucaLorenzelli/Thinkstock

“Previous studies have found differences in the clinical characteristics of AD depending on age of AD onset, ethnic background, and AD severity,” senior author Jonathan I. Silverberg, MD, PhD, MPH, director of clinical research in the department of dermatology at George Washington University, Washington, and his coauthor wrote in the study, which was published online in JAAD International. “However, none have prospectively compared the clinical characteristics and associated signs by age group. Improved understanding of the clinical phenotypes of AD may help guide choice of treatment and improve health outcomes,” they added.

Along with coauthor Sheena Chatrath, a dermatology research fellow in the department, Dr. Silverberg prospectively reviewed self-reported questionnaires that were completed by 380 patients prior to their visit at GWU’s eczema clinic between 2013 and 2019. Questions included age of AD onset, sociodemographics, Visual Analog Scale (VAS) itch and sleep for Scoring AD, and Numeric Rating Scale (NRS) for skin pain and itch. The researchers used the Eczema Area Severity Index to assess AD severity and a dermatologist conducted full body skin exams, noting the distribution of AD involvement as well as associated signs.

Of the 380 patients, 6.1% were younger than aged 18 years, 46.3% were young adults aged 18-39 years, and 47.6% were older adults 40 years of age and older.

Dr. Jonathan I. Silverberg

Compared with pediatric patients, both young and older adults were less likely to experience AD on the ankles (adjusted odds ratio [aOR], 0.41 and 0.43, respectively), moderate to severe AD lesions on flexures (aOR, 0.47 and 0.30), pityriasis alba (aOR, 0.24 and 0.07), oozing lesions (aOR, 0.44 and 0.35), and moderate to severe excoriations (aOR, 0.49 and 0.44).

In children, severe itch was more common, reported in 47.1%, compared with 43.4% of the young adults and 38.6% of the older adults, and itch was less severe among the young and older adults. “Interestingly, despite increased itch in pediatric patients, we found no difference in the severity of skin pain across all age groups,” the researchers wrote. “Moreover, pediatric patients reported skin pain less often than adult patients. This may be due to age-related differences of pain perception.”

In other findings, compared with pediatric patients, young adults were more likely to experience AD around the eyes (aOR, 2.92), while older adults were less likely to experience AD on elbows (aOR, 0.34), nipples (aOR, 0.40), knees (aOR, 0.27), and less likely to have keratosis pilaris (aOR, 0.38), and lichenification (aOR, 0.47).

Dr. Silverberg and Ms. Chatrath used latent class analysis to identify four classes for distribution of AD lesions. In this model, class 1 had low probabilities of AD involvement at all sites examined and class 2 had low probabilities of scalp, face, and foot involvement, and intermediate probability of all other AD sites. Class 3 had low probabilities of hand and foot involvement, high probability of facial erythema, and intermediate probability of all other AD signs, while class 4 had intermediate probability of postauricular and foot involvement, and high probability of all other AD sites examined.



“Pediatric patients were most commonly in class 4 (33.3%), followed by class 1 and 2 (26.7%), and least commonly in class 3 (13.3%),” the authors wrote. “In young adults, class 4 and 1 were most common (32.4% and 29.4%), followed by class 2 (27.9%), and least commonly class 3 (10.3%). In older adults, class 1 was most common (40.3%), followed by class 4 (23.6%), and least commonly classes 2 and 3 (18.1%).”

The researchers also used latent class analysis to identify four classes for the signs and symptoms of AD. In this model, class 1 had zero-low probability of all AD signs and class 2 had low probability of all AD signs. Class 3 had high probability of oozing lesions and low probability of all other signs, while class 4 had high probability of xerosis, intermediate probability of ichthyosis and palmar hyperlinearity, and low probability of all other AD signs.

In all three groups, the most common class was class 1 (85.6% of older adults, 81.8% of younger adults, and 82.6% of pediatric patients). Among the pediatric patients, they wrote, “class 3 was the second most common (8.7%), followed by class 2 and 4 (4.4%).” Among the young adults, 9.7% were in class 2, 5.7% were in class 4, and 2.8% were in class 3; and among the older adults, 8.3% were in class 4, 4.4% were in class 2, and 1.67% were in class 3.

Zelma Chiesa Fuxench, MD, of the department of dermatology at the University of Pennsylvania, Philadelphia, who was asked to comment on the study, said that while AD is traditionally largely thought of as a disease of children primarily involving the flexural areas, “this study provides additional evidence to support that AD is more than just a disease of childhood with a fixed clinical presentation, but is a heterogeneous disease whose clinical presentation varies across different population groups.”

Dr. Zelma Chiesa Fuxench


While the study provides insight into the clinical differences that may be observed across AD groups, “care must be taken when interpreting these results as the study was done in a single center with observations collected during one single visit,” she added. “AD is not a ‘static’ disease; its presentation can stay the same in one patient but can vary even in another patient throughout their lifetime. Therefore, studies of a more prospective nature that evaluate the change in clinical presentation using multiple measures throughout time in these individuals would be a step forward to better understand if these phenotypic differences truly exist and, as such, what implications could they have for treatment selection.”

This study was supported by grants from the Agency for Healthcare Research and Quality and the Dermatology Foundation. The researchers reported having no disclosures. Dr. Chiesa Fuxench disclosed serving as a consultant for the Asthma and Allergy Foundation of America, National Eczema Association, Pfizer, AbbVie, and Incyte, for which she has received honoraria for AD-related work. She is the recipient of research grants through Regeneron, Sanofi, Tioga, Vanda, Menlo Therapeutics, Leo Pharma, and Eli Lilly for work related to AD as well as honoraria for continuing medical education work related to AD sponsored through educational grants from Regeneron/Sanofi and Pfizer.
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‘Concerning’ uptick in pediatric antipsychotic prescribing

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There has been a substantial increase over the last 20 years in antipsychotic prescribing among children and adolescents in England – especially among those with autism, an analysis of primary care records from 7.2 million children and adolescents aged 3-18 years shows.

“This study demonstrates a concerning trend in antipsychotic prescribing in children and adolescents,” study investigator Matthias Pierce, PhD, senior research fellow at the University of Manchester (England) Center for Women’s Mental Health, who jointly led the study, said in a news release.

Dr. Matthias Pierce

“We do not think the changes in prescribing necessarily relate to changes in clinical need; rather, it may be more likely to reflect changes in prescribing practice by clinicians,” Dr. Pierce said.

The study was published online in The Lancet Psychiatry.
 

Increase in long-term use

Between 2000 and 2019, prescriptions for antipsychotics nearly doubled from 0.06% to 0.11%.

The investigators note that the U.K.’s National Institute for Health and Care Excellence has approved the use of some antipsychotics in patients younger than age 18 with schizophrenia, bipolar disorder, and severely aggressive behavior attributable to conduct disorder.

However, these data suggest antipsychotics are being prescribed for an increasingly broad range of conditions, most commonly autism, but also for attention-deficit/ hyperactivity disorder, tic disorders like Tourrette syndrome, and learning difficulties.

“Broadening use of antipsychotics in developing young people begs questions about their safety over time and demands more research on this topic,” senior author Kathryn Abel, MBBS, PhD, from the University of Manchester said in the news release.

During the study period, antipsychotic prescribing in primary care increased by an average of 3.3% per year and the rate of first prescriptions increased by 2.2% per year.

The data also suggest that more children and adolescents are taking these powerful drugs for longer periods of time. The proportion receiving antipsychotics for at least 6 months after an initial prescription rose from 41.9% in 2000 to 62.8% in 2018.
 

Prescribing inequities

From 2009 onwards, more than 90% of prescriptions were for atypical antipsychotics.

Over time, risperidone dominated, with more than 60% of all prescriptions, followed by aripiprazole, quetiapine, olanzapine, and haloperidol as the most prescribed antipsychotics.

Boys and older children aged 15-18 years were most likely to receive an antipsychotic. However, the increasing trends were evident in all groups.

The data also point to inequities in prescribing as a result of deprivation levels, with typical antipsychotics prescribed more frequently in more deprived areas over time.

Dr. Pierce said he hopes this study will “help clinicians to evaluate the prescribing of antipsychotics to children more fully and will encourage them to consider better access to alternatives.”

Dr. Abel noted that antipsychotic medications “continue to have a valuable role in the treatment of serious mental illness. These findings represent a descriptive account of antipsychotic prescribing to children and adolescents in the U.K. today and provide a window onto current practice.”
 

Findings are no surprise

Emily Simonoff, MD, professor of child and adolescent psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, offered perspective on the study in a statement from the U.K. nonprofit Science Media Centre.

Dr. Emily Simonoff

“To clinicians, it will not be surprising that the authors demonstrate an increase in rates of prescriptions over that time period, as there has been a steadily emerging evidence base for the benefits of this group of medication for a range of different indications, which has been further supported by new licensing indications and recommendations from NICE,” Dr. Simonoff said.

For example, “there is good evidence for their benefits for other conditions such as irritability in autism spectrum disorder.

“However, it should also be noted that NICE recommendations for their use in many conditions is as part of a multimodal treatment plan, for example including psychological or behavioral interventions. It’s unclear from the study whether such recommendations were being followed or medication was being used on its own,” she added.

Dr. Simonoff also said it’s “reassuring” that prescribing rates remain very low in the youngest children and notes that the authors “rightly highlight the need for high-quality, longer-term studies on efficacy and, most importantly, adverse effects. This should be a research priority.”

The study had no funding. The authors report no relevant financial relationships. Dr. Simonoff is a member of the NICE guideline development group for the management of autism and has published on the efficacy of antipsychotic medication for irritability in autism.

A version of this article first appeared on Medscape.com.

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There has been a substantial increase over the last 20 years in antipsychotic prescribing among children and adolescents in England – especially among those with autism, an analysis of primary care records from 7.2 million children and adolescents aged 3-18 years shows.

“This study demonstrates a concerning trend in antipsychotic prescribing in children and adolescents,” study investigator Matthias Pierce, PhD, senior research fellow at the University of Manchester (England) Center for Women’s Mental Health, who jointly led the study, said in a news release.

Dr. Matthias Pierce

“We do not think the changes in prescribing necessarily relate to changes in clinical need; rather, it may be more likely to reflect changes in prescribing practice by clinicians,” Dr. Pierce said.

The study was published online in The Lancet Psychiatry.
 

Increase in long-term use

Between 2000 and 2019, prescriptions for antipsychotics nearly doubled from 0.06% to 0.11%.

The investigators note that the U.K.’s National Institute for Health and Care Excellence has approved the use of some antipsychotics in patients younger than age 18 with schizophrenia, bipolar disorder, and severely aggressive behavior attributable to conduct disorder.

However, these data suggest antipsychotics are being prescribed for an increasingly broad range of conditions, most commonly autism, but also for attention-deficit/ hyperactivity disorder, tic disorders like Tourrette syndrome, and learning difficulties.

“Broadening use of antipsychotics in developing young people begs questions about their safety over time and demands more research on this topic,” senior author Kathryn Abel, MBBS, PhD, from the University of Manchester said in the news release.

During the study period, antipsychotic prescribing in primary care increased by an average of 3.3% per year and the rate of first prescriptions increased by 2.2% per year.

The data also suggest that more children and adolescents are taking these powerful drugs for longer periods of time. The proportion receiving antipsychotics for at least 6 months after an initial prescription rose from 41.9% in 2000 to 62.8% in 2018.
 

Prescribing inequities

From 2009 onwards, more than 90% of prescriptions were for atypical antipsychotics.

Over time, risperidone dominated, with more than 60% of all prescriptions, followed by aripiprazole, quetiapine, olanzapine, and haloperidol as the most prescribed antipsychotics.

Boys and older children aged 15-18 years were most likely to receive an antipsychotic. However, the increasing trends were evident in all groups.

The data also point to inequities in prescribing as a result of deprivation levels, with typical antipsychotics prescribed more frequently in more deprived areas over time.

Dr. Pierce said he hopes this study will “help clinicians to evaluate the prescribing of antipsychotics to children more fully and will encourage them to consider better access to alternatives.”

Dr. Abel noted that antipsychotic medications “continue to have a valuable role in the treatment of serious mental illness. These findings represent a descriptive account of antipsychotic prescribing to children and adolescents in the U.K. today and provide a window onto current practice.”
 

Findings are no surprise

Emily Simonoff, MD, professor of child and adolescent psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, offered perspective on the study in a statement from the U.K. nonprofit Science Media Centre.

Dr. Emily Simonoff

“To clinicians, it will not be surprising that the authors demonstrate an increase in rates of prescriptions over that time period, as there has been a steadily emerging evidence base for the benefits of this group of medication for a range of different indications, which has been further supported by new licensing indications and recommendations from NICE,” Dr. Simonoff said.

For example, “there is good evidence for their benefits for other conditions such as irritability in autism spectrum disorder.

“However, it should also be noted that NICE recommendations for their use in many conditions is as part of a multimodal treatment plan, for example including psychological or behavioral interventions. It’s unclear from the study whether such recommendations were being followed or medication was being used on its own,” she added.

Dr. Simonoff also said it’s “reassuring” that prescribing rates remain very low in the youngest children and notes that the authors “rightly highlight the need for high-quality, longer-term studies on efficacy and, most importantly, adverse effects. This should be a research priority.”

The study had no funding. The authors report no relevant financial relationships. Dr. Simonoff is a member of the NICE guideline development group for the management of autism and has published on the efficacy of antipsychotic medication for irritability in autism.

A version of this article first appeared on Medscape.com.

There has been a substantial increase over the last 20 years in antipsychotic prescribing among children and adolescents in England – especially among those with autism, an analysis of primary care records from 7.2 million children and adolescents aged 3-18 years shows.

“This study demonstrates a concerning trend in antipsychotic prescribing in children and adolescents,” study investigator Matthias Pierce, PhD, senior research fellow at the University of Manchester (England) Center for Women’s Mental Health, who jointly led the study, said in a news release.

Dr. Matthias Pierce

“We do not think the changes in prescribing necessarily relate to changes in clinical need; rather, it may be more likely to reflect changes in prescribing practice by clinicians,” Dr. Pierce said.

The study was published online in The Lancet Psychiatry.
 

Increase in long-term use

Between 2000 and 2019, prescriptions for antipsychotics nearly doubled from 0.06% to 0.11%.

The investigators note that the U.K.’s National Institute for Health and Care Excellence has approved the use of some antipsychotics in patients younger than age 18 with schizophrenia, bipolar disorder, and severely aggressive behavior attributable to conduct disorder.

However, these data suggest antipsychotics are being prescribed for an increasingly broad range of conditions, most commonly autism, but also for attention-deficit/ hyperactivity disorder, tic disorders like Tourrette syndrome, and learning difficulties.

“Broadening use of antipsychotics in developing young people begs questions about their safety over time and demands more research on this topic,” senior author Kathryn Abel, MBBS, PhD, from the University of Manchester said in the news release.

During the study period, antipsychotic prescribing in primary care increased by an average of 3.3% per year and the rate of first prescriptions increased by 2.2% per year.

The data also suggest that more children and adolescents are taking these powerful drugs for longer periods of time. The proportion receiving antipsychotics for at least 6 months after an initial prescription rose from 41.9% in 2000 to 62.8% in 2018.
 

Prescribing inequities

From 2009 onwards, more than 90% of prescriptions were for atypical antipsychotics.

Over time, risperidone dominated, with more than 60% of all prescriptions, followed by aripiprazole, quetiapine, olanzapine, and haloperidol as the most prescribed antipsychotics.

Boys and older children aged 15-18 years were most likely to receive an antipsychotic. However, the increasing trends were evident in all groups.

The data also point to inequities in prescribing as a result of deprivation levels, with typical antipsychotics prescribed more frequently in more deprived areas over time.

Dr. Pierce said he hopes this study will “help clinicians to evaluate the prescribing of antipsychotics to children more fully and will encourage them to consider better access to alternatives.”

Dr. Abel noted that antipsychotic medications “continue to have a valuable role in the treatment of serious mental illness. These findings represent a descriptive account of antipsychotic prescribing to children and adolescents in the U.K. today and provide a window onto current practice.”
 

Findings are no surprise

Emily Simonoff, MD, professor of child and adolescent psychiatry, Institute of Psychiatry, Psychology & Neuroscience, King’s College London, offered perspective on the study in a statement from the U.K. nonprofit Science Media Centre.

Dr. Emily Simonoff

“To clinicians, it will not be surprising that the authors demonstrate an increase in rates of prescriptions over that time period, as there has been a steadily emerging evidence base for the benefits of this group of medication for a range of different indications, which has been further supported by new licensing indications and recommendations from NICE,” Dr. Simonoff said.

For example, “there is good evidence for their benefits for other conditions such as irritability in autism spectrum disorder.

“However, it should also be noted that NICE recommendations for their use in many conditions is as part of a multimodal treatment plan, for example including psychological or behavioral interventions. It’s unclear from the study whether such recommendations were being followed or medication was being used on its own,” she added.

Dr. Simonoff also said it’s “reassuring” that prescribing rates remain very low in the youngest children and notes that the authors “rightly highlight the need for high-quality, longer-term studies on efficacy and, most importantly, adverse effects. This should be a research priority.”

The study had no funding. The authors report no relevant financial relationships. Dr. Simonoff is a member of the NICE guideline development group for the management of autism and has published on the efficacy of antipsychotic medication for irritability in autism.

A version of this article first appeared on Medscape.com.

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Kids with concussions may benefit from early return to school

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Children and teens with concussions who returned to school sooner showed fewer symptoms after 2 weeks than those who returned to school later, based on data from more than 1,600 individuals aged 5-18 years.

The timing for return to school after a concussion has been the subject of guidelines, but data on how the timing of school returns affects later symptom burdens are limited, Christopher G. Vaughan, PhD, of Children’s National Hospital, Rockville, Md., and colleagues wrote.

Examining how the timing of return to school (RTS) affects later symptoms is needed to inform early postinjury management, they said.

In the new study published in JAMA Network Open, the researchers identified 1,630 children and teens aged 5-18 years who were treated for concussions at nine Canadian pediatric EDs. The primary outcome was symptom burden at 14 days post concussion, based on the Post-Concussion Symptom Inventory (PCSI). Early RTS was defined as missing fewer than 3 days of school post concussion.

Overall, the mean number of missed school days was 3.74 (excluding weekends). When divided by age, the mean number of missed days was 2.61 for children aged 5-7 years, 3.26 for those aged 8-12 years, and 4.71 for those aged 13-18 years.

Slightly more than half (53.7%) of the participants had an early RTS of 2 missed days or fewer. Later RTS was most common in the oldest age group, followed by the middle and younger age groups.

The researchers used a propensity score–matched analysis to determine associations. At 14 days, an early RTS was associated with reduced symptoms among 8- to 12-year-olds and 13- to 18-year-olds, though not in the youngest patients aged 5-7 years. In addition, the researchers created quantiles based on initial symptom ratings.

For the youngest age group, the association between early RTS and reduced symptoms at day 14 was higher among those with lower initial symptoms.

For the two older groups, the association was higher for those with higher initial symptoms (based on the PCSI).

The findings that earlier RTS was associated with a lower symptom burden at day 14 for those with higher levels of symptoms at baseline was surprising, but the mechanisms of the timing and effect of RTS requires more study, the researchers wrote in their discussion.

The effect of early RTS on symptoms may be in part related to factors such as “the benefits of socialization, reduced stress from not missing too much school, maintaining or returning to a normal sleep-wake schedule, and returning to light to moderate physical activity (gym class and recreational activities),” the researchers noted.

Another study related to recovery and concussion recently appeared in Neurology. In that study, the authors found that those athletes who took a longer time to recover from a sports-related concussion could still return to play with additional time off, but the methods and populations differed from the current study, which focused on RTS rather than returning to play.

The current study findings were limited by several factors including the lack of randomization for RTS timing and a lack of data on the variety of potential supports and accommodations students received, the researchers noted.

However, the results were strengthened by the large size and diverse nature of the concussions, and the roughly equal representation of boys and girls, they said.

Although randomized trials are needed to determine the best timing for RTS, the current study suggests that RTS within 2 days of a concussion is associated with improved symptoms, “and may directly or indirectly promote faster recovery,” they concluded.
 

 

 

Early return remains feasible for most children and teens

“Return to school can be a complicated issue for children and teens with concussions,” said Caitlyn Mooney, MD, a pediatrician and specialist in sports medicine at the University of Texas Health Science Center, San Antonio, said in an interview. Although much research has focused on diagnosis and return to sport after a concussion, there has been less focus on returning to school and learning. Various issues post concussion can make schooling difficult, and students may experience trouble with vision, concentration, sleep, headaches, and more.

Despite this knowledge, studies that specifically address recommended school protocols are limited, Dr. Mooney said. “Additionally, all concussions are different; while some students will need minimal help to return and succeed in school, others may need individualized learning plans and accommodations for school.” A return to school ideally would be a team-based approach with input from the parent, patient, physician, and educators.

“The theory of cognitive rest stems from the idea that a concussion causes metabolic dysfunction in the brain, and that increasing the metabolic demands of the brain can result in symptoms and a delayed return to school,” said Dr. Mooney.

Evidence suggests that those who start resting early after a concussion improve more quickly, “but there has been ongoing discussion over the years of what is the correct balance of cognitive rest to returning to modified activity,” she said. “This has led to the current general recommendation of rest for 24-48 hours followed by a gradual return to school as tolerated.”

Although the current study is large, it is limited by the lack of randomization, Dr. Mooney noted, therefore conclusions cannot be made that the cause of the improved symptoms is a quicker return to school.

However, the results support data from previous studies, in that both of the older age groups showed less disease burden at 14 days after an earlier return to school, she said.

“With prolonged absences, adolescents get isolated at home away from friends, and they may have increased mood symptoms. Additionally, I have found a high number of my patients who do not go to school as quickly have more sleep disturbance, which seems to increase symptoms such as difficulty concentrating or headaches,” she said. “It seems like the students do benefit from a routine schedule even if they have to have some accommodations at school, especially older students who may have more stress about missing school and falling behind on schoolwork.”

The message for pediatricians is that return to school should be individualized, Dr. Mooney said.

Although the current study does not dictate the optimal return to school, the results support those of previous studies in showing that, after 1-2 days of rest, an early return does not harm children and teens and may improve symptoms in many cases, she said. “In my experience, sometimes schools find it easier to keep the student at home rather than manage rest or special accommodations,” but the current study suggests that delaying return to school may not be the right choice for many patients.

“I hope this study empowers clinicians to advocate for these students, that the right place for them is in the classroom even with rest, extra time, or other accommodations,” said Dr. Mooney.

“Each concussion should be evaluated and treated individually; there will likely be a few who may need to stay home for a longer period of time, but this study suggests that the majority of students will suffer no ill effects from returning to the normal routine after a 2-day rest,” she noted.

The study was supported by the Canadian Institutes for Health Research. Dr. Vaughan and several coauthors disclosed being authors of the Postconcussion Symptom Inventory outside of the current study. Dr. Mooney had no financial conflicts to disclose.

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Children and teens with concussions who returned to school sooner showed fewer symptoms after 2 weeks than those who returned to school later, based on data from more than 1,600 individuals aged 5-18 years.

The timing for return to school after a concussion has been the subject of guidelines, but data on how the timing of school returns affects later symptom burdens are limited, Christopher G. Vaughan, PhD, of Children’s National Hospital, Rockville, Md., and colleagues wrote.

Examining how the timing of return to school (RTS) affects later symptoms is needed to inform early postinjury management, they said.

In the new study published in JAMA Network Open, the researchers identified 1,630 children and teens aged 5-18 years who were treated for concussions at nine Canadian pediatric EDs. The primary outcome was symptom burden at 14 days post concussion, based on the Post-Concussion Symptom Inventory (PCSI). Early RTS was defined as missing fewer than 3 days of school post concussion.

Overall, the mean number of missed school days was 3.74 (excluding weekends). When divided by age, the mean number of missed days was 2.61 for children aged 5-7 years, 3.26 for those aged 8-12 years, and 4.71 for those aged 13-18 years.

Slightly more than half (53.7%) of the participants had an early RTS of 2 missed days or fewer. Later RTS was most common in the oldest age group, followed by the middle and younger age groups.

The researchers used a propensity score–matched analysis to determine associations. At 14 days, an early RTS was associated with reduced symptoms among 8- to 12-year-olds and 13- to 18-year-olds, though not in the youngest patients aged 5-7 years. In addition, the researchers created quantiles based on initial symptom ratings.

For the youngest age group, the association between early RTS and reduced symptoms at day 14 was higher among those with lower initial symptoms.

For the two older groups, the association was higher for those with higher initial symptoms (based on the PCSI).

The findings that earlier RTS was associated with a lower symptom burden at day 14 for those with higher levels of symptoms at baseline was surprising, but the mechanisms of the timing and effect of RTS requires more study, the researchers wrote in their discussion.

The effect of early RTS on symptoms may be in part related to factors such as “the benefits of socialization, reduced stress from not missing too much school, maintaining or returning to a normal sleep-wake schedule, and returning to light to moderate physical activity (gym class and recreational activities),” the researchers noted.

Another study related to recovery and concussion recently appeared in Neurology. In that study, the authors found that those athletes who took a longer time to recover from a sports-related concussion could still return to play with additional time off, but the methods and populations differed from the current study, which focused on RTS rather than returning to play.

The current study findings were limited by several factors including the lack of randomization for RTS timing and a lack of data on the variety of potential supports and accommodations students received, the researchers noted.

However, the results were strengthened by the large size and diverse nature of the concussions, and the roughly equal representation of boys and girls, they said.

Although randomized trials are needed to determine the best timing for RTS, the current study suggests that RTS within 2 days of a concussion is associated with improved symptoms, “and may directly or indirectly promote faster recovery,” they concluded.
 

 

 

Early return remains feasible for most children and teens

“Return to school can be a complicated issue for children and teens with concussions,” said Caitlyn Mooney, MD, a pediatrician and specialist in sports medicine at the University of Texas Health Science Center, San Antonio, said in an interview. Although much research has focused on diagnosis and return to sport after a concussion, there has been less focus on returning to school and learning. Various issues post concussion can make schooling difficult, and students may experience trouble with vision, concentration, sleep, headaches, and more.

Despite this knowledge, studies that specifically address recommended school protocols are limited, Dr. Mooney said. “Additionally, all concussions are different; while some students will need minimal help to return and succeed in school, others may need individualized learning plans and accommodations for school.” A return to school ideally would be a team-based approach with input from the parent, patient, physician, and educators.

“The theory of cognitive rest stems from the idea that a concussion causes metabolic dysfunction in the brain, and that increasing the metabolic demands of the brain can result in symptoms and a delayed return to school,” said Dr. Mooney.

Evidence suggests that those who start resting early after a concussion improve more quickly, “but there has been ongoing discussion over the years of what is the correct balance of cognitive rest to returning to modified activity,” she said. “This has led to the current general recommendation of rest for 24-48 hours followed by a gradual return to school as tolerated.”

Although the current study is large, it is limited by the lack of randomization, Dr. Mooney noted, therefore conclusions cannot be made that the cause of the improved symptoms is a quicker return to school.

However, the results support data from previous studies, in that both of the older age groups showed less disease burden at 14 days after an earlier return to school, she said.

“With prolonged absences, adolescents get isolated at home away from friends, and they may have increased mood symptoms. Additionally, I have found a high number of my patients who do not go to school as quickly have more sleep disturbance, which seems to increase symptoms such as difficulty concentrating or headaches,” she said. “It seems like the students do benefit from a routine schedule even if they have to have some accommodations at school, especially older students who may have more stress about missing school and falling behind on schoolwork.”

The message for pediatricians is that return to school should be individualized, Dr. Mooney said.

Although the current study does not dictate the optimal return to school, the results support those of previous studies in showing that, after 1-2 days of rest, an early return does not harm children and teens and may improve symptoms in many cases, she said. “In my experience, sometimes schools find it easier to keep the student at home rather than manage rest or special accommodations,” but the current study suggests that delaying return to school may not be the right choice for many patients.

“I hope this study empowers clinicians to advocate for these students, that the right place for them is in the classroom even with rest, extra time, or other accommodations,” said Dr. Mooney.

“Each concussion should be evaluated and treated individually; there will likely be a few who may need to stay home for a longer period of time, but this study suggests that the majority of students will suffer no ill effects from returning to the normal routine after a 2-day rest,” she noted.

The study was supported by the Canadian Institutes for Health Research. Dr. Vaughan and several coauthors disclosed being authors of the Postconcussion Symptom Inventory outside of the current study. Dr. Mooney had no financial conflicts to disclose.

Children and teens with concussions who returned to school sooner showed fewer symptoms after 2 weeks than those who returned to school later, based on data from more than 1,600 individuals aged 5-18 years.

The timing for return to school after a concussion has been the subject of guidelines, but data on how the timing of school returns affects later symptom burdens are limited, Christopher G. Vaughan, PhD, of Children’s National Hospital, Rockville, Md., and colleagues wrote.

Examining how the timing of return to school (RTS) affects later symptoms is needed to inform early postinjury management, they said.

In the new study published in JAMA Network Open, the researchers identified 1,630 children and teens aged 5-18 years who were treated for concussions at nine Canadian pediatric EDs. The primary outcome was symptom burden at 14 days post concussion, based on the Post-Concussion Symptom Inventory (PCSI). Early RTS was defined as missing fewer than 3 days of school post concussion.

Overall, the mean number of missed school days was 3.74 (excluding weekends). When divided by age, the mean number of missed days was 2.61 for children aged 5-7 years, 3.26 for those aged 8-12 years, and 4.71 for those aged 13-18 years.

Slightly more than half (53.7%) of the participants had an early RTS of 2 missed days or fewer. Later RTS was most common in the oldest age group, followed by the middle and younger age groups.

The researchers used a propensity score–matched analysis to determine associations. At 14 days, an early RTS was associated with reduced symptoms among 8- to 12-year-olds and 13- to 18-year-olds, though not in the youngest patients aged 5-7 years. In addition, the researchers created quantiles based on initial symptom ratings.

For the youngest age group, the association between early RTS and reduced symptoms at day 14 was higher among those with lower initial symptoms.

For the two older groups, the association was higher for those with higher initial symptoms (based on the PCSI).

The findings that earlier RTS was associated with a lower symptom burden at day 14 for those with higher levels of symptoms at baseline was surprising, but the mechanisms of the timing and effect of RTS requires more study, the researchers wrote in their discussion.

The effect of early RTS on symptoms may be in part related to factors such as “the benefits of socialization, reduced stress from not missing too much school, maintaining or returning to a normal sleep-wake schedule, and returning to light to moderate physical activity (gym class and recreational activities),” the researchers noted.

Another study related to recovery and concussion recently appeared in Neurology. In that study, the authors found that those athletes who took a longer time to recover from a sports-related concussion could still return to play with additional time off, but the methods and populations differed from the current study, which focused on RTS rather than returning to play.

The current study findings were limited by several factors including the lack of randomization for RTS timing and a lack of data on the variety of potential supports and accommodations students received, the researchers noted.

However, the results were strengthened by the large size and diverse nature of the concussions, and the roughly equal representation of boys and girls, they said.

Although randomized trials are needed to determine the best timing for RTS, the current study suggests that RTS within 2 days of a concussion is associated with improved symptoms, “and may directly or indirectly promote faster recovery,” they concluded.
 

 

 

Early return remains feasible for most children and teens

“Return to school can be a complicated issue for children and teens with concussions,” said Caitlyn Mooney, MD, a pediatrician and specialist in sports medicine at the University of Texas Health Science Center, San Antonio, said in an interview. Although much research has focused on diagnosis and return to sport after a concussion, there has been less focus on returning to school and learning. Various issues post concussion can make schooling difficult, and students may experience trouble with vision, concentration, sleep, headaches, and more.

Despite this knowledge, studies that specifically address recommended school protocols are limited, Dr. Mooney said. “Additionally, all concussions are different; while some students will need minimal help to return and succeed in school, others may need individualized learning plans and accommodations for school.” A return to school ideally would be a team-based approach with input from the parent, patient, physician, and educators.

“The theory of cognitive rest stems from the idea that a concussion causes metabolic dysfunction in the brain, and that increasing the metabolic demands of the brain can result in symptoms and a delayed return to school,” said Dr. Mooney.

Evidence suggests that those who start resting early after a concussion improve more quickly, “but there has been ongoing discussion over the years of what is the correct balance of cognitive rest to returning to modified activity,” she said. “This has led to the current general recommendation of rest for 24-48 hours followed by a gradual return to school as tolerated.”

Although the current study is large, it is limited by the lack of randomization, Dr. Mooney noted, therefore conclusions cannot be made that the cause of the improved symptoms is a quicker return to school.

However, the results support data from previous studies, in that both of the older age groups showed less disease burden at 14 days after an earlier return to school, she said.

“With prolonged absences, adolescents get isolated at home away from friends, and they may have increased mood symptoms. Additionally, I have found a high number of my patients who do not go to school as quickly have more sleep disturbance, which seems to increase symptoms such as difficulty concentrating or headaches,” she said. “It seems like the students do benefit from a routine schedule even if they have to have some accommodations at school, especially older students who may have more stress about missing school and falling behind on schoolwork.”

The message for pediatricians is that return to school should be individualized, Dr. Mooney said.

Although the current study does not dictate the optimal return to school, the results support those of previous studies in showing that, after 1-2 days of rest, an early return does not harm children and teens and may improve symptoms in many cases, she said. “In my experience, sometimes schools find it easier to keep the student at home rather than manage rest or special accommodations,” but the current study suggests that delaying return to school may not be the right choice for many patients.

“I hope this study empowers clinicians to advocate for these students, that the right place for them is in the classroom even with rest, extra time, or other accommodations,” said Dr. Mooney.

“Each concussion should be evaluated and treated individually; there will likely be a few who may need to stay home for a longer period of time, but this study suggests that the majority of students will suffer no ill effects from returning to the normal routine after a 2-day rest,” she noted.

The study was supported by the Canadian Institutes for Health Research. Dr. Vaughan and several coauthors disclosed being authors of the Postconcussion Symptom Inventory outside of the current study. Dr. Mooney had no financial conflicts to disclose.

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Highly anticipated HIV vaccine fails in large trial

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The only HIV vaccine nearing the completion of testing trials is not effective at preventing HIV, officials announced Wednesday.

The vaccine had been in development since 2019 and was given to 3,900 study participants through October 2022, but data shows it does not protect against HIV compared with a placebo, according to developer Janssen Pharmaceutical.

Experts estimate the failure means there won’t be another potential vaccine on the horizon for 3 to 5 years, the New York Times reported.

“It’s obviously disappointing,” Anthony Fauci, MD, former head of the National Institute of Allergy and Infectious Diseases, told MSNBC, noting that other areas of HIV treatment research are promising. “I don’t think that people should give up on the field of the HIV vaccine.”

No safety issues had been identified with the vaccine during the trial, which studied the experimental treatment in men who have sex with men or with transgender people.

There is no cure for HIV, but disease progression can be managed with existing treatments. HIV attacks the body’s immune system and destroys white blood cells, increasing the risk of other infections. More than 1.5 million people worldwide were infected with HIV in 2021 and 38.4 million people are living with the virus, according to UNAIDS.

A version of this article first appeared on WebMD.com.

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The only HIV vaccine nearing the completion of testing trials is not effective at preventing HIV, officials announced Wednesday.

The vaccine had been in development since 2019 and was given to 3,900 study participants through October 2022, but data shows it does not protect against HIV compared with a placebo, according to developer Janssen Pharmaceutical.

Experts estimate the failure means there won’t be another potential vaccine on the horizon for 3 to 5 years, the New York Times reported.

“It’s obviously disappointing,” Anthony Fauci, MD, former head of the National Institute of Allergy and Infectious Diseases, told MSNBC, noting that other areas of HIV treatment research are promising. “I don’t think that people should give up on the field of the HIV vaccine.”

No safety issues had been identified with the vaccine during the trial, which studied the experimental treatment in men who have sex with men or with transgender people.

There is no cure for HIV, but disease progression can be managed with existing treatments. HIV attacks the body’s immune system and destroys white blood cells, increasing the risk of other infections. More than 1.5 million people worldwide were infected with HIV in 2021 and 38.4 million people are living with the virus, according to UNAIDS.

A version of this article first appeared on WebMD.com.

The only HIV vaccine nearing the completion of testing trials is not effective at preventing HIV, officials announced Wednesday.

The vaccine had been in development since 2019 and was given to 3,900 study participants through October 2022, but data shows it does not protect against HIV compared with a placebo, according to developer Janssen Pharmaceutical.

Experts estimate the failure means there won’t be another potential vaccine on the horizon for 3 to 5 years, the New York Times reported.

“It’s obviously disappointing,” Anthony Fauci, MD, former head of the National Institute of Allergy and Infectious Diseases, told MSNBC, noting that other areas of HIV treatment research are promising. “I don’t think that people should give up on the field of the HIV vaccine.”

No safety issues had been identified with the vaccine during the trial, which studied the experimental treatment in men who have sex with men or with transgender people.

There is no cure for HIV, but disease progression can be managed with existing treatments. HIV attacks the body’s immune system and destroys white blood cells, increasing the risk of other infections. More than 1.5 million people worldwide were infected with HIV in 2021 and 38.4 million people are living with the virus, according to UNAIDS.

A version of this article first appeared on WebMD.com.

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Is it time for yet another COVID booster? It’s complicated

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On Twitter, as in real life, it’s a question on many minds: When should we think about the next COVID-19 vaccine? Or should we?

For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?

At this point, no one knows for sure, but new guidance may be on the docket.

On Jan. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.

According to the FDA announcement, after the meeting, “the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.”

From there, the CDC will take up the issue and decide on recommendations.

The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That’s up from 346 a day for the week ending Dec. 28.

Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan. 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.
 

COVID vaccines, 2023 and beyond

Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.

“I think we probably will need another booster,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and codirector of the Center for Vaccine Development at Texas Children’s Hospital in Houston. “The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?” 

The trivalent booster, he suggested, might include something more protective against XBB.1.5.

The bivalent booster gives “broadened immunity” that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, WebMD’s sister site for health professionals.

In his publication Ground Truths, Dr. Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.

Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation. 

While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that’s population-wide.

“People who fall into those three groups do benefit,” he says, “but the recommendation is everyone over 6 months get the bivalent, and what I’m asking is, ‘Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?’ ”
 

 

 

Evolving research

“We are trying to understand how to stay one step ahead rather than several steps behind [the virus],“ says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?

Much more research has become available recently about the bivalent vaccine and its effectiveness, Dr. Osterholm says. “The bivalent vaccine is working as well as we could have expected,” he says, especially in high-risk people and in those over age 65. “The challenge we have is, what does that mean going forward?”

In his review, Dr. Topol concludes: “There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent’s benefit over the original booster.”

Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared with the original booster shots. Two others showed no real difference.

“The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots,” Dr. Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.

Dr. Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.

Boosters do matter, Dr. Offit says. “But not for all.” In a perspective published Jan. 11 in the New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Dr. Offit wrote that boosting is best reserved for vulnerable groups.

Chasing the variants with a bivalent vaccine, he says, “has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other.”

Dr. Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them “with vaccines containing mRNA from strains that might disappear a few months later.”

The CDC needs to parse the data by subgroups, Dr. Offit says. “The critical question is, ‘Who gets hospitalized and who is dying? Who are they?’ ”

That data should take into account age, ethnicity, vaccine history, and other factors, Dr. Offit says, because right now, there is no great data to say, “OK, everyone gets a boost.”
 

Future vaccine costs

Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared with the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.

The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.

The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-Vt.), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.

“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients.”

He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.

While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?

“I think so, yes,” Dr. Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.

“The government is balking at paying for the boosters,” he says. “I think it’s very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they’ve gotten from the American people, I think they should not be gouging at this point.”

He noted that the federal government provided not just money to the companies for the vaccines, but a “glide path” through the FDA for the vaccine approvals.
 

Are new, variant-specific boosters coming?

Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?

Novavax, approved in July 2022 as a primary series and in some cases as a booster, is “also developing an Omicron-containing bivalent vaccine at the direction of public health agencies,” says spokesperson Alison Chartan.

Pfizer responded: “When and if we have something to share we will let you know.”

Moderna did not respond.

A version of this article first appeared on WebMD.com.

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On Twitter, as in real life, it’s a question on many minds: When should we think about the next COVID-19 vaccine? Or should we?

For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?

At this point, no one knows for sure, but new guidance may be on the docket.

On Jan. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.

According to the FDA announcement, after the meeting, “the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.”

From there, the CDC will take up the issue and decide on recommendations.

The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That’s up from 346 a day for the week ending Dec. 28.

Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan. 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.
 

COVID vaccines, 2023 and beyond

Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.

“I think we probably will need another booster,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and codirector of the Center for Vaccine Development at Texas Children’s Hospital in Houston. “The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?” 

The trivalent booster, he suggested, might include something more protective against XBB.1.5.

The bivalent booster gives “broadened immunity” that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, WebMD’s sister site for health professionals.

In his publication Ground Truths, Dr. Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.

Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation. 

While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that’s population-wide.

“People who fall into those three groups do benefit,” he says, “but the recommendation is everyone over 6 months get the bivalent, and what I’m asking is, ‘Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?’ ”
 

 

 

Evolving research

“We are trying to understand how to stay one step ahead rather than several steps behind [the virus],“ says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?

Much more research has become available recently about the bivalent vaccine and its effectiveness, Dr. Osterholm says. “The bivalent vaccine is working as well as we could have expected,” he says, especially in high-risk people and in those over age 65. “The challenge we have is, what does that mean going forward?”

In his review, Dr. Topol concludes: “There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent’s benefit over the original booster.”

Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared with the original booster shots. Two others showed no real difference.

“The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots,” Dr. Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.

Dr. Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.

Boosters do matter, Dr. Offit says. “But not for all.” In a perspective published Jan. 11 in the New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Dr. Offit wrote that boosting is best reserved for vulnerable groups.

Chasing the variants with a bivalent vaccine, he says, “has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other.”

Dr. Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them “with vaccines containing mRNA from strains that might disappear a few months later.”

The CDC needs to parse the data by subgroups, Dr. Offit says. “The critical question is, ‘Who gets hospitalized and who is dying? Who are they?’ ”

That data should take into account age, ethnicity, vaccine history, and other factors, Dr. Offit says, because right now, there is no great data to say, “OK, everyone gets a boost.”
 

Future vaccine costs

Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared with the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.

The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.

The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-Vt.), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.

“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients.”

He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.

While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?

“I think so, yes,” Dr. Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.

“The government is balking at paying for the boosters,” he says. “I think it’s very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they’ve gotten from the American people, I think they should not be gouging at this point.”

He noted that the federal government provided not just money to the companies for the vaccines, but a “glide path” through the FDA for the vaccine approvals.
 

Are new, variant-specific boosters coming?

Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?

Novavax, approved in July 2022 as a primary series and in some cases as a booster, is “also developing an Omicron-containing bivalent vaccine at the direction of public health agencies,” says spokesperson Alison Chartan.

Pfizer responded: “When and if we have something to share we will let you know.”

Moderna did not respond.

A version of this article first appeared on WebMD.com.

On Twitter, as in real life, it’s a question on many minds: When should we think about the next COVID-19 vaccine? Or should we?

For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?

At this point, no one knows for sure, but new guidance may be on the docket.

On Jan. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.

According to the FDA announcement, after the meeting, “the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.”

From there, the CDC will take up the issue and decide on recommendations.

The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That’s up from 346 a day for the week ending Dec. 28.

Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan. 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.
 

COVID vaccines, 2023 and beyond

Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.

“I think we probably will need another booster,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and codirector of the Center for Vaccine Development at Texas Children’s Hospital in Houston. “The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?” 

The trivalent booster, he suggested, might include something more protective against XBB.1.5.

The bivalent booster gives “broadened immunity” that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, WebMD’s sister site for health professionals.

In his publication Ground Truths, Dr. Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.

Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation. 

While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that’s population-wide.

“People who fall into those three groups do benefit,” he says, “but the recommendation is everyone over 6 months get the bivalent, and what I’m asking is, ‘Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?’ ”
 

 

 

Evolving research

“We are trying to understand how to stay one step ahead rather than several steps behind [the virus],“ says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.

Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?

Much more research has become available recently about the bivalent vaccine and its effectiveness, Dr. Osterholm says. “The bivalent vaccine is working as well as we could have expected,” he says, especially in high-risk people and in those over age 65. “The challenge we have is, what does that mean going forward?”

In his review, Dr. Topol concludes: “There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent’s benefit over the original booster.”

Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared with the original booster shots. Two others showed no real difference.

“The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots,” Dr. Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.

Dr. Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.

Boosters do matter, Dr. Offit says. “But not for all.” In a perspective published Jan. 11 in the New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Dr. Offit wrote that boosting is best reserved for vulnerable groups.

Chasing the variants with a bivalent vaccine, he says, “has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other.”

Dr. Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them “with vaccines containing mRNA from strains that might disappear a few months later.”

The CDC needs to parse the data by subgroups, Dr. Offit says. “The critical question is, ‘Who gets hospitalized and who is dying? Who are they?’ ”

That data should take into account age, ethnicity, vaccine history, and other factors, Dr. Offit says, because right now, there is no great data to say, “OK, everyone gets a boost.”
 

Future vaccine costs

Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared with the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.

The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.

The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-Vt.), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.

“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients.”

He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.

While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?

“I think so, yes,” Dr. Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.

“The government is balking at paying for the boosters,” he says. “I think it’s very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they’ve gotten from the American people, I think they should not be gouging at this point.”

He noted that the federal government provided not just money to the companies for the vaccines, but a “glide path” through the FDA for the vaccine approvals.
 

Are new, variant-specific boosters coming?

Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?

Novavax, approved in July 2022 as a primary series and in some cases as a booster, is “also developing an Omicron-containing bivalent vaccine at the direction of public health agencies,” says spokesperson Alison Chartan.

Pfizer responded: “When and if we have something to share we will let you know.”

Moderna did not respond.

A version of this article first appeared on WebMD.com.

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