Conference Coverage

Contrary to popular belief, no association appeared between the number of intensive care unit beds and COVID-19 deaths, based on a review of data from all 50 states between March 1, 2020, and June 30, 2021.

One of the reasons for poor patient outcomes in the early months of the COVID-19 pandemic was the presumed scarcity of ICU beds, Omar Haider, MD, of Houston Methodist Hospital, and colleagues said. “We hypothesized that the states having a lower number of ICU beds had more COVID-related deaths when compared to the states that had a higher number of ICU beds,” they wrote in an abstract presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

According to the researchers, the total number of ICU beds in the United States is approximately 85,000. Hawaii has the highest number of beds per 10,000 persons, and the District of Columbia has the lowest (6.0 vs. 1.6).

The researchers collected data on ICU bed totals from the Kaiser Family Foundation. Statistics on COVID-19 deaths were obtained from The New York Times database, which provided real-time information collected from the Department of Health & Human Services, the Centers for Disease Control and Prevention, and the Census Bureau.

The researchers used the Pearson Correlation Coefficient to compare ICU beds and COVID deaths per 10,000 persons in each state. The R value was 0.29, which indicates no inverse correlation. “Our value of R2, the coefficient of determination, was 0.0858,” they added. They confirmed the results using the Spearman’s Rho, which yielded an rs of 0.3, also a sign of no inverse correlation. No correlation was found between low numbers of ICU beds and high numbers of COVID-19 deaths for any states.

The study findings were limited by several factors, including the lack of standardized reporting timelines across states, differences in state-based vaccination rates, the emergence of the Delta variant during the study period, and time-lag in contemporaneous database updates, the researchers noted.

However, the results suggest that physical ICU beds do not play a role in determining the number of COVID-related deaths. Instead, “other constraints such as less staffing, lack of medical supplies (ventilators and [personal protective equipment]) should be evaluated for potential implications on poor patients’ outcomes,” they concluded.
 

Pandemic challenges can inform future plans

“As the health care system emerges from the effects of the pandemic, it is important to understand the factors that contributed to adverse outcomes to better prepare for future challenges and improve the delivery of care,” Suman Pal, MBBS, of the University of New Mexico, Albuquerque, said in an interview. 

“The findings are not surprising considering what is known about the multitude of factors that determine outcomes for our patients from medical comorbidities, and social determinants of health to upstream structural factors such as systemic inequities and generational trauma,” said Dr. Pal, who was not involved with the study. “Thus, a simple correlation of the number of ICU beds to COVID-19 outcomes is not likely to capture the interplay of all these factors.”

The challenges of the pandemic offer insights to inform future planning, said Dr. Pal.

“In my opinion, a key factor to understand and address would be employee wellness for health care workers,” he said. “The problem of burnout leading to health care workers leaving the workforce has exacerbated the already acute shortages in personnel in recent years.

“In the long term, it may be prudent to reconsider the approach to health by increasing support for preventative and primary care, addressing social factors such as education, nutrition, and housing, to mitigate preventable aspects of diseases.”

Further research is needed to examine the multitude of factors associated with the pandemic, and their interplay, said Dr. Pal. The goals of such research “would be needed to develop a deeper understanding of the factors that contributed to mortality in COVID-19 and the disparities with this across different subpopulations.”

The study received no outside funding. The researchers and Dr. Pal disclosed no relevant financial relationships.

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

Contrary to popular belief, no association appeared between the number of intensive care unit beds and COVID-19 deaths, based on a review of data from all 50 states between March 1, 2020, and June 30, 2021.

One of the reasons for poor patient outcomes in the early months of the COVID-19 pandemic was the presumed scarcity of ICU beds, Omar Haider, MD, of Houston Methodist Hospital, and colleagues said. “We hypothesized that the states having a lower number of ICU beds had more COVID-related deaths when compared to the states that had a higher number of ICU beds,” they wrote in an abstract presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

According to the researchers, the total number of ICU beds in the United States is approximately 85,000. Hawaii has the highest number of beds per 10,000 persons, and the District of Columbia has the lowest (6.0 vs. 1.6).

The researchers collected data on ICU bed totals from the Kaiser Family Foundation. Statistics on COVID-19 deaths were obtained from The New York Times database, which provided real-time information collected from the Department of Health & Human Services, the Centers for Disease Control and Prevention, and the Census Bureau.

The researchers used the Pearson Correlation Coefficient to compare ICU beds and COVID deaths per 10,000 persons in each state. The R value was 0.29, which indicates no inverse correlation. “Our value of R2, the coefficient of determination, was 0.0858,” they added. They confirmed the results using the Spearman’s Rho, which yielded an rs of 0.3, also a sign of no inverse correlation. No correlation was found between low numbers of ICU beds and high numbers of COVID-19 deaths for any states.

The study findings were limited by several factors, including the lack of standardized reporting timelines across states, differences in state-based vaccination rates, the emergence of the Delta variant during the study period, and time-lag in contemporaneous database updates, the researchers noted.

However, the results suggest that physical ICU beds do not play a role in determining the number of COVID-related deaths. Instead, “other constraints such as less staffing, lack of medical supplies (ventilators and [personal protective equipment]) should be evaluated for potential implications on poor patients’ outcomes,” they concluded.
 

Pandemic challenges can inform future plans

“As the health care system emerges from the effects of the pandemic, it is important to understand the factors that contributed to adverse outcomes to better prepare for future challenges and improve the delivery of care,” Suman Pal, MBBS, of the University of New Mexico, Albuquerque, said in an interview. 

“The findings are not surprising considering what is known about the multitude of factors that determine outcomes for our patients from medical comorbidities, and social determinants of health to upstream structural factors such as systemic inequities and generational trauma,” said Dr. Pal, who was not involved with the study. “Thus, a simple correlation of the number of ICU beds to COVID-19 outcomes is not likely to capture the interplay of all these factors.”

The challenges of the pandemic offer insights to inform future planning, said Dr. Pal.

“In my opinion, a key factor to understand and address would be employee wellness for health care workers,” he said. “The problem of burnout leading to health care workers leaving the workforce has exacerbated the already acute shortages in personnel in recent years.

“In the long term, it may be prudent to reconsider the approach to health by increasing support for preventative and primary care, addressing social factors such as education, nutrition, and housing, to mitigate preventable aspects of diseases.”

Further research is needed to examine the multitude of factors associated with the pandemic, and their interplay, said Dr. Pal. The goals of such research “would be needed to develop a deeper understanding of the factors that contributed to mortality in COVID-19 and the disparities with this across different subpopulations.”

The study received no outside funding. The researchers and Dr. Pal disclosed no relevant financial relationships.

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

Contrary to popular belief, no association appeared between the number of intensive care unit beds and COVID-19 deaths, based on a review of data from all 50 states between March 1, 2020, and June 30, 2021.

One of the reasons for poor patient outcomes in the early months of the COVID-19 pandemic was the presumed scarcity of ICU beds, Omar Haider, MD, of Houston Methodist Hospital, and colleagues said. “We hypothesized that the states having a lower number of ICU beds had more COVID-related deaths when compared to the states that had a higher number of ICU beds,” they wrote in an abstract presented at the Critical Care Congress sponsored by the Society of Critical Care Medicine.

According to the researchers, the total number of ICU beds in the United States is approximately 85,000. Hawaii has the highest number of beds per 10,000 persons, and the District of Columbia has the lowest (6.0 vs. 1.6).

The researchers collected data on ICU bed totals from the Kaiser Family Foundation. Statistics on COVID-19 deaths were obtained from The New York Times database, which provided real-time information collected from the Department of Health & Human Services, the Centers for Disease Control and Prevention, and the Census Bureau.

The researchers used the Pearson Correlation Coefficient to compare ICU beds and COVID deaths per 10,000 persons in each state. The R value was 0.29, which indicates no inverse correlation. “Our value of R2, the coefficient of determination, was 0.0858,” they added. They confirmed the results using the Spearman’s Rho, which yielded an rs of 0.3, also a sign of no inverse correlation. No correlation was found between low numbers of ICU beds and high numbers of COVID-19 deaths for any states.

The study findings were limited by several factors, including the lack of standardized reporting timelines across states, differences in state-based vaccination rates, the emergence of the Delta variant during the study period, and time-lag in contemporaneous database updates, the researchers noted.

However, the results suggest that physical ICU beds do not play a role in determining the number of COVID-related deaths. Instead, “other constraints such as less staffing, lack of medical supplies (ventilators and [personal protective equipment]) should be evaluated for potential implications on poor patients’ outcomes,” they concluded.
 

Pandemic challenges can inform future plans

“As the health care system emerges from the effects of the pandemic, it is important to understand the factors that contributed to adverse outcomes to better prepare for future challenges and improve the delivery of care,” Suman Pal, MBBS, of the University of New Mexico, Albuquerque, said in an interview. 

“The findings are not surprising considering what is known about the multitude of factors that determine outcomes for our patients from medical comorbidities, and social determinants of health to upstream structural factors such as systemic inequities and generational trauma,” said Dr. Pal, who was not involved with the study. “Thus, a simple correlation of the number of ICU beds to COVID-19 outcomes is not likely to capture the interplay of all these factors.”

The challenges of the pandemic offer insights to inform future planning, said Dr. Pal.

“In my opinion, a key factor to understand and address would be employee wellness for health care workers,” he said. “The problem of burnout leading to health care workers leaving the workforce has exacerbated the already acute shortages in personnel in recent years.

“In the long term, it may be prudent to reconsider the approach to health by increasing support for preventative and primary care, addressing social factors such as education, nutrition, and housing, to mitigate preventable aspects of diseases.”

Further research is needed to examine the multitude of factors associated with the pandemic, and their interplay, said Dr. Pal. The goals of such research “would be needed to develop a deeper understanding of the factors that contributed to mortality in COVID-19 and the disparities with this across different subpopulations.”

The study received no outside funding. The researchers and Dr. Pal disclosed no relevant financial relationships.

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

Toddlers who watched more TV were significantly more likely than those who watched less TV to consume sugar-sweetened drinks and junk foods, based on data from 529 children.

Previous research had shown an association between screen time and poor diet, but most have involved school-aged children; the relationship in toddlers has not been well studied, Melissa R. Lutz, MD, of Johns Hopkins University, Baltimore, said in a presentation at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics currently recommends no digital media for children younger than 18-24 months, and an hour or less daily for children aged 2-5 years.

To examine the association between TV time and dietary practices in 2-year-olds, the researchers conducted a secondary analysis of data from 529 children who presented for their 2-year-old well-child visit at a single center. The study population was 52% Latino/Hispanic and 30% non-Latino/Hispanic Black, and 69% had an annual household income less than $20,000. The median time spent watching TV daily was 42 minutes. The data were taken from participants in the Greenlight Intervention Study, a randomized trial of an obesity prevention program at four academic pediatric primary care clinics in the United States.

Daily screen time and dietary practices were based on parent reports, and included daily volume of juice, daily counts of fruits and vegetables, daily count of junk foods such as chips, ice cream, French fries, and fast food, and consumption of sugar-sweetened beverages. The cross-sectional analysis controlled for race/ethnicity, Women, Infants, and Children Program benefits, number of children at home, caregiver education level, and family income.

In adjusted analysis, more than an hour of TV time was significantly associated with junk food intake, with odds ratios of 1.12 for 90 minutes and 1.25 for 120 minutes (P < .05 for both). Similar associations were seen for TV times of 90 minutes and 120 minutes and intake of fast food and sugar-sweetened beverages.

Additionally, the researchers found that toddlers who watched TV during mealtimes were more than twice as likely to consume sugar-sweetened beverages (OR, 2.74), junk food (OR, 2.72), fast food (OR, 2.09), and only about half as likely to consume fruits and vegetables (OR, 0.62).

The study findings were limited by several factors including the cross-sectional design, the reliance on caregiver self-reports, potential for residual confounding, and the low average screen time, Dr. Lutz noted.

However, the results suggest that “increased screen TV time and mealtime TV were both associated with poor dietary practices in 2-year-old children,” she said.

Future research should include analysis of passive screen time, as well as the relationship between screen time and diet with other digital devices beyond TV, she added.
 

COVID drove screen time higher

The current study is especially important at this time because of the increased screen exposure for many young children in the wake of the ongoing pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. “Screen time use is up even more than before [the pandemic], and this study is a reminder to ask parents of young children about screen time and dietary history.”

Dr. Kinsella said she was not surprised by the study findings. In her practice, “I see families with more screen time use in general who also are more likely to have juice and junk food available. If kids had no access to screens, I believe they would still have access to unhealthy foods. I believe more research is needed into why screen time is so high in some families.”

The study received funding from NIH. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Toddlers who watched more TV were significantly more likely than those who watched less TV to consume sugar-sweetened drinks and junk foods, based on data from 529 children.

Previous research had shown an association between screen time and poor diet, but most have involved school-aged children; the relationship in toddlers has not been well studied, Melissa R. Lutz, MD, of Johns Hopkins University, Baltimore, said in a presentation at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics currently recommends no digital media for children younger than 18-24 months, and an hour or less daily for children aged 2-5 years.

To examine the association between TV time and dietary practices in 2-year-olds, the researchers conducted a secondary analysis of data from 529 children who presented for their 2-year-old well-child visit at a single center. The study population was 52% Latino/Hispanic and 30% non-Latino/Hispanic Black, and 69% had an annual household income less than $20,000. The median time spent watching TV daily was 42 minutes. The data were taken from participants in the Greenlight Intervention Study, a randomized trial of an obesity prevention program at four academic pediatric primary care clinics in the United States.

Daily screen time and dietary practices were based on parent reports, and included daily volume of juice, daily counts of fruits and vegetables, daily count of junk foods such as chips, ice cream, French fries, and fast food, and consumption of sugar-sweetened beverages. The cross-sectional analysis controlled for race/ethnicity, Women, Infants, and Children Program benefits, number of children at home, caregiver education level, and family income.

In adjusted analysis, more than an hour of TV time was significantly associated with junk food intake, with odds ratios of 1.12 for 90 minutes and 1.25 for 120 minutes (P < .05 for both). Similar associations were seen for TV times of 90 minutes and 120 minutes and intake of fast food and sugar-sweetened beverages.

Additionally, the researchers found that toddlers who watched TV during mealtimes were more than twice as likely to consume sugar-sweetened beverages (OR, 2.74), junk food (OR, 2.72), fast food (OR, 2.09), and only about half as likely to consume fruits and vegetables (OR, 0.62).

The study findings were limited by several factors including the cross-sectional design, the reliance on caregiver self-reports, potential for residual confounding, and the low average screen time, Dr. Lutz noted.

However, the results suggest that “increased screen TV time and mealtime TV were both associated with poor dietary practices in 2-year-old children,” she said.

Future research should include analysis of passive screen time, as well as the relationship between screen time and diet with other digital devices beyond TV, she added.
 

COVID drove screen time higher

The current study is especially important at this time because of the increased screen exposure for many young children in the wake of the ongoing pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. “Screen time use is up even more than before [the pandemic], and this study is a reminder to ask parents of young children about screen time and dietary history.”

Dr. Kinsella said she was not surprised by the study findings. In her practice, “I see families with more screen time use in general who also are more likely to have juice and junk food available. If kids had no access to screens, I believe they would still have access to unhealthy foods. I believe more research is needed into why screen time is so high in some families.”

The study received funding from NIH. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Toddlers who watched more TV were significantly more likely than those who watched less TV to consume sugar-sweetened drinks and junk foods, based on data from 529 children.

Previous research had shown an association between screen time and poor diet, but most have involved school-aged children; the relationship in toddlers has not been well studied, Melissa R. Lutz, MD, of Johns Hopkins University, Baltimore, said in a presentation at the Pediatric Academic Societies annual meeting.

The American Academy of Pediatrics currently recommends no digital media for children younger than 18-24 months, and an hour or less daily for children aged 2-5 years.

To examine the association between TV time and dietary practices in 2-year-olds, the researchers conducted a secondary analysis of data from 529 children who presented for their 2-year-old well-child visit at a single center. The study population was 52% Latino/Hispanic and 30% non-Latino/Hispanic Black, and 69% had an annual household income less than $20,000. The median time spent watching TV daily was 42 minutes. The data were taken from participants in the Greenlight Intervention Study, a randomized trial of an obesity prevention program at four academic pediatric primary care clinics in the United States.

Daily screen time and dietary practices were based on parent reports, and included daily volume of juice, daily counts of fruits and vegetables, daily count of junk foods such as chips, ice cream, French fries, and fast food, and consumption of sugar-sweetened beverages. The cross-sectional analysis controlled for race/ethnicity, Women, Infants, and Children Program benefits, number of children at home, caregiver education level, and family income.

In adjusted analysis, more than an hour of TV time was significantly associated with junk food intake, with odds ratios of 1.12 for 90 minutes and 1.25 for 120 minutes (P < .05 for both). Similar associations were seen for TV times of 90 minutes and 120 minutes and intake of fast food and sugar-sweetened beverages.

Additionally, the researchers found that toddlers who watched TV during mealtimes were more than twice as likely to consume sugar-sweetened beverages (OR, 2.74), junk food (OR, 2.72), fast food (OR, 2.09), and only about half as likely to consume fruits and vegetables (OR, 0.62).

The study findings were limited by several factors including the cross-sectional design, the reliance on caregiver self-reports, potential for residual confounding, and the low average screen time, Dr. Lutz noted.

However, the results suggest that “increased screen TV time and mealtime TV were both associated with poor dietary practices in 2-year-old children,” she said.

Future research should include analysis of passive screen time, as well as the relationship between screen time and diet with other digital devices beyond TV, she added.
 

COVID drove screen time higher

The current study is especially important at this time because of the increased screen exposure for many young children in the wake of the ongoing pandemic, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview. “Screen time use is up even more than before [the pandemic], and this study is a reminder to ask parents of young children about screen time and dietary history.”

Dr. Kinsella said she was not surprised by the study findings. In her practice, “I see families with more screen time use in general who also are more likely to have juice and junk food available. If kids had no access to screens, I believe they would still have access to unhealthy foods. I believe more research is needed into why screen time is so high in some families.”

The study received funding from NIH. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.

Climate-informed clinical encounters have the potential to enhance pediatric care in a variety of ways, according to Aaron Bernstein, MD, of Boston Children’s Hospital.

“Each primary care visit offers opportunities to screen for and support children burdened with risks to health that are increasingly intense due to climate change,” Rebecca P. Philipsborn, MD, of Emory University, Atlanta, and colleagues wrote in “A pediatrician’s guide to climate change–informed primary care,” on which Dr. Bernstein served as corresponding author (Curr Probl Pediatr Adolesc Health Care. 2021 June. doi: 10.1016/j.cppeds.2021.101027).

In a presentation at the annual meeting of the Pediatric Academic Societies, Dr. Bernstein highlighted five components of climate-informed pediatric care mentioned in the article: climate-informed screening, health promotion that includes health and climate benefits, care management that anticipates climate risks for at-risk children, climate-informed anticipatory guidance, and engagement with community resources and advocacy.

Pediatricians can incorporate climate-related issues into screening protocols by asking patients about their home environment, Dr. Bernstein said. Potential questions to ask include whether the family has air conditioning in the home, and whether they are concerned about being able to pay the bill if they use air conditioning, he said.

Health promotion discussions during clinical encounters can emphasize that eating more fruits and vegetables not only is good for the health of the child and the whole family, but “also is good for the planet we live on,” he said.

Care management strategies should anticipate climate risks for at-risk children, such those with complex or chronic medical conditions, and outdoor athletes for whom air quality might be an issue, he said.

Medication management has a climate-informed aspect, Dr. Bernstein said. “How safe are the medications you prescribe?” he asked. During the summer months, the relative risk of hospitalization with heat exposure is increased for a range of drugs including ACE inhibitors (RR 1.42), loop diuretics (RR 1.52), stimulants (RR 1.53), anticholinergics (RR 1.26), antipsychotics (RR 1.51), and beta-blockers (RR 1.08), he noted.

For children who play outdoor sports, previous studies suggest they acclimatize for approximately 7 days if traveling prior to vigorous exercise outdoors. “Monitor the heat index and limit the intensity or length of exercise on extreme heat index days,” Dr. Bernstein said. He emphasized the need to remind children and parents to try to limit intense physical activity to the coolest parts of the day, before 10 a.m. and after 4 p.m., to wear sunscreen and light-colored, lightweight clothing, and to drink 5-8 ounces of fluid every 20 minutes during exercise.

Approximately 12% of all-cause attributable fractions of emergency department visits are associated with heat exposure, Dr. Bernstein added. He recommended that pediatricians and patients be aware of airnow.gov and iqair.com as resources to monitor air quality. Pay attention to the heat index, which factors in humidity and presents the real-feel temperature, not just the thermometer reading.

Last but not least, Dr. Bernstein explained that pediatricians can use a clinical visit to ask adolescent patients about civic engagement, and offer resources for those who want to learn more about climate change, such as climatechangeresources.org/organizations-kids/.

For more detailed guidance, Dr. Bernstein recommended “A pediatrician’s guide to climate change–informed primary care.”

Use websites and handouts

Including climate issues in pediatric visits is definitely important, Suzanne Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview.

“Some questions are more critical in warm weather environments where children are at higher risk for dehydration and heat exposure,” said Dr. Boulter, who was not involved with the guide preparation. “The list of suggestions for participation in outdoor sports in hot weather is comprehensive, and the data on ER visits in summer months is surprising,” she noted. However, some of the data could have included more explanation, such as what air quality actually measures, and the difference between ambient temperature and heat index, and how they are calculated, she noted.

Questions about diet, air conditioning, and backup power sources may be covered in other areas of the pediatric visit, or on questionnaires prior to the visit, Dr. Boulter added.

The main barrier to incorporating climate-related information during the pediatric visit is the limited time allotted for the visit and number of topics to address, said Dr. Boulter. “Pediatric practices that have websites could post seasonal reminders about sports participation health in hot weather, or have printed brief handouts for patients in the office,” she noted. Alternatively, guidance about sports and the impact of climate could easily be given as a short handout to families during the health visit, she said.

Future research might include a focus on assessing families’ knowledge and behavior before and after climate change counseling, Dr. Boulter added.

Dr. Bernstein and Dr. Boulter had no financial conflicts to disclose. Dr. Boulter serves on the editorial advisory board of Pediatric News.

Climate-informed clinical encounters have the potential to enhance pediatric care in a variety of ways, according to Aaron Bernstein, MD, of Boston Children’s Hospital.

“Each primary care visit offers opportunities to screen for and support children burdened with risks to health that are increasingly intense due to climate change,” Rebecca P. Philipsborn, MD, of Emory University, Atlanta, and colleagues wrote in “A pediatrician’s guide to climate change–informed primary care,” on which Dr. Bernstein served as corresponding author (Curr Probl Pediatr Adolesc Health Care. 2021 June. doi: 10.1016/j.cppeds.2021.101027).

In a presentation at the annual meeting of the Pediatric Academic Societies, Dr. Bernstein highlighted five components of climate-informed pediatric care mentioned in the article: climate-informed screening, health promotion that includes health and climate benefits, care management that anticipates climate risks for at-risk children, climate-informed anticipatory guidance, and engagement with community resources and advocacy.

Pediatricians can incorporate climate-related issues into screening protocols by asking patients about their home environment, Dr. Bernstein said. Potential questions to ask include whether the family has air conditioning in the home, and whether they are concerned about being able to pay the bill if they use air conditioning, he said.

Health promotion discussions during clinical encounters can emphasize that eating more fruits and vegetables not only is good for the health of the child and the whole family, but “also is good for the planet we live on,” he said.

Care management strategies should anticipate climate risks for at-risk children, such those with complex or chronic medical conditions, and outdoor athletes for whom air quality might be an issue, he said.

Medication management has a climate-informed aspect, Dr. Bernstein said. “How safe are the medications you prescribe?” he asked. During the summer months, the relative risk of hospitalization with heat exposure is increased for a range of drugs including ACE inhibitors (RR 1.42), loop diuretics (RR 1.52), stimulants (RR 1.53), anticholinergics (RR 1.26), antipsychotics (RR 1.51), and beta-blockers (RR 1.08), he noted.

For children who play outdoor sports, previous studies suggest they acclimatize for approximately 7 days if traveling prior to vigorous exercise outdoors. “Monitor the heat index and limit the intensity or length of exercise on extreme heat index days,” Dr. Bernstein said. He emphasized the need to remind children and parents to try to limit intense physical activity to the coolest parts of the day, before 10 a.m. and after 4 p.m., to wear sunscreen and light-colored, lightweight clothing, and to drink 5-8 ounces of fluid every 20 minutes during exercise.

Approximately 12% of all-cause attributable fractions of emergency department visits are associated with heat exposure, Dr. Bernstein added. He recommended that pediatricians and patients be aware of airnow.gov and iqair.com as resources to monitor air quality. Pay attention to the heat index, which factors in humidity and presents the real-feel temperature, not just the thermometer reading.

Last but not least, Dr. Bernstein explained that pediatricians can use a clinical visit to ask adolescent patients about civic engagement, and offer resources for those who want to learn more about climate change, such as climatechangeresources.org/organizations-kids/.

For more detailed guidance, Dr. Bernstein recommended “A pediatrician’s guide to climate change–informed primary care.”

Use websites and handouts

Including climate issues in pediatric visits is definitely important, Suzanne Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview.

“Some questions are more critical in warm weather environments where children are at higher risk for dehydration and heat exposure,” said Dr. Boulter, who was not involved with the guide preparation. “The list of suggestions for participation in outdoor sports in hot weather is comprehensive, and the data on ER visits in summer months is surprising,” she noted. However, some of the data could have included more explanation, such as what air quality actually measures, and the difference between ambient temperature and heat index, and how they are calculated, she noted.

Questions about diet, air conditioning, and backup power sources may be covered in other areas of the pediatric visit, or on questionnaires prior to the visit, Dr. Boulter added.

The main barrier to incorporating climate-related information during the pediatric visit is the limited time allotted for the visit and number of topics to address, said Dr. Boulter. “Pediatric practices that have websites could post seasonal reminders about sports participation health in hot weather, or have printed brief handouts for patients in the office,” she noted. Alternatively, guidance about sports and the impact of climate could easily be given as a short handout to families during the health visit, she said.

Future research might include a focus on assessing families’ knowledge and behavior before and after climate change counseling, Dr. Boulter added.

Dr. Bernstein and Dr. Boulter had no financial conflicts to disclose. Dr. Boulter serves on the editorial advisory board of Pediatric News.

Climate-informed clinical encounters have the potential to enhance pediatric care in a variety of ways, according to Aaron Bernstein, MD, of Boston Children’s Hospital.

“Each primary care visit offers opportunities to screen for and support children burdened with risks to health that are increasingly intense due to climate change,” Rebecca P. Philipsborn, MD, of Emory University, Atlanta, and colleagues wrote in “A pediatrician’s guide to climate change–informed primary care,” on which Dr. Bernstein served as corresponding author (Curr Probl Pediatr Adolesc Health Care. 2021 June. doi: 10.1016/j.cppeds.2021.101027).

In a presentation at the annual meeting of the Pediatric Academic Societies, Dr. Bernstein highlighted five components of climate-informed pediatric care mentioned in the article: climate-informed screening, health promotion that includes health and climate benefits, care management that anticipates climate risks for at-risk children, climate-informed anticipatory guidance, and engagement with community resources and advocacy.

Pediatricians can incorporate climate-related issues into screening protocols by asking patients about their home environment, Dr. Bernstein said. Potential questions to ask include whether the family has air conditioning in the home, and whether they are concerned about being able to pay the bill if they use air conditioning, he said.

Health promotion discussions during clinical encounters can emphasize that eating more fruits and vegetables not only is good for the health of the child and the whole family, but “also is good for the planet we live on,” he said.

Care management strategies should anticipate climate risks for at-risk children, such those with complex or chronic medical conditions, and outdoor athletes for whom air quality might be an issue, he said.

Medication management has a climate-informed aspect, Dr. Bernstein said. “How safe are the medications you prescribe?” he asked. During the summer months, the relative risk of hospitalization with heat exposure is increased for a range of drugs including ACE inhibitors (RR 1.42), loop diuretics (RR 1.52), stimulants (RR 1.53), anticholinergics (RR 1.26), antipsychotics (RR 1.51), and beta-blockers (RR 1.08), he noted.

For children who play outdoor sports, previous studies suggest they acclimatize for approximately 7 days if traveling prior to vigorous exercise outdoors. “Monitor the heat index and limit the intensity or length of exercise on extreme heat index days,” Dr. Bernstein said. He emphasized the need to remind children and parents to try to limit intense physical activity to the coolest parts of the day, before 10 a.m. and after 4 p.m., to wear sunscreen and light-colored, lightweight clothing, and to drink 5-8 ounces of fluid every 20 minutes during exercise.

Approximately 12% of all-cause attributable fractions of emergency department visits are associated with heat exposure, Dr. Bernstein added. He recommended that pediatricians and patients be aware of airnow.gov and iqair.com as resources to monitor air quality. Pay attention to the heat index, which factors in humidity and presents the real-feel temperature, not just the thermometer reading.

Last but not least, Dr. Bernstein explained that pediatricians can use a clinical visit to ask adolescent patients about civic engagement, and offer resources for those who want to learn more about climate change, such as climatechangeresources.org/organizations-kids/.

For more detailed guidance, Dr. Bernstein recommended “A pediatrician’s guide to climate change–informed primary care.”

Use websites and handouts

Including climate issues in pediatric visits is definitely important, Suzanne Boulter, MD, of the Geisel School of Medicine at Dartmouth, Hanover, N.H., said in an interview.

“Some questions are more critical in warm weather environments where children are at higher risk for dehydration and heat exposure,” said Dr. Boulter, who was not involved with the guide preparation. “The list of suggestions for participation in outdoor sports in hot weather is comprehensive, and the data on ER visits in summer months is surprising,” she noted. However, some of the data could have included more explanation, such as what air quality actually measures, and the difference between ambient temperature and heat index, and how they are calculated, she noted.

Questions about diet, air conditioning, and backup power sources may be covered in other areas of the pediatric visit, or on questionnaires prior to the visit, Dr. Boulter added.

The main barrier to incorporating climate-related information during the pediatric visit is the limited time allotted for the visit and number of topics to address, said Dr. Boulter. “Pediatric practices that have websites could post seasonal reminders about sports participation health in hot weather, or have printed brief handouts for patients in the office,” she noted. Alternatively, guidance about sports and the impact of climate could easily be given as a short handout to families during the health visit, she said.

Future research might include a focus on assessing families’ knowledge and behavior before and after climate change counseling, Dr. Boulter added.

Dr. Bernstein and Dr. Boulter had no financial conflicts to disclose. Dr. Boulter serves on the editorial advisory board of Pediatric News.

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

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

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

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

A medication used to reduce fluid retention can also safely be used to prevent a dangerous lung condition that affects newborns, particularly those born premature, according to a new study.

Furosemide (Lasix) – which can reduce excess fluid in the body caused by heart failure, liver disease, and kidney trouble – is commonly used off-label to prevent bronchopulmonary dysplasia (BPD), a disorder that causes irritation and poor development of lungs in premature infants. But until now, researchers have not studied its safety in this setting.

BPD often affects babies born more than 2 months early and can sometimes result in breathing difficulties into adolescence and young adulthood.

“There are so few drugs that have been tested for newborns, and there are very little data to help neonatologists decide if certain medications are safe and effective,” said Rachel Greenberg, MD, MHS, a neonatologist and member of the Duke Clinical Research Institute, Durham, N.C. “We found there was no greater risk of safety events for newborns given furosemide.”

Dr. Greenberg presented the findings at the 2022 Pediatric Academic Societies meeting in Denver.

For the 28-day randomized controlled trial, Dr. Greenberg and colleagues enrolled 80 preterm newborns, born at less than 29 weeks’ gestation, at 17 centers within the Eunice Kennedy Shriver National Institute of Child Health and Human Development Pediatric Trials Network. Of those, 61 received furosemide and 19 received a placebo.

Although babies given furosemide had more problems with electrolytes – an expected outcome from the use of diuretic medications – the researchers observed no greater risk for more serious issues, namely hearing loss or kidney stones, Dr. Greenberg told this news organization.

“The mechanism here is we know that extra fluid can damage the lungs and can cause you to have to use more respiratory support and more oxygen,” she said. “The thought from a physiological standpoint is using a diuretic can decrease fluid in the lungs and lead to improvements in lung outcomes.”

The researchers did not observe a reduction in BDP or death in babies who received furosemide, but Dr. Greenberg said the study was underpowered to detect such an effect.

“We were not powered to detect a difference in that outcome; the overall objective of this study was always to evaluate safety,” she said. “Of course, we wanted to capture variables that would measure effectiveness as well.

“Because this was a pragmatic trial, we did not limit the amount of fluids that the clinicians could give the participating infants. This could have impacted the effectiveness of furosemide. We would need a different design and larger study to truly determine effectiveness.” 

Dr. Greenberg said she hoped the new data will provide greater insight to neonatal providers and help bolster future, more large-scale trials using furosemide in premature infants.   

The drug has previously been associated with both kidney stones and ototoxicity, which occurs when medication causes a person to develop hearing or balance problems, said Nicolas Bamat, MD, MSCE, assistant professor of pediatrics at the Perelman School of Medicine, University of Pennsylvania, Philadelphia.

Although the number of children in the latest study was too small to generate any firm conclusions, he said, the trial provides the best data to date on furosemide in premature infants.

The medication is used frequently both on babies at risk of developing BPD and babies who have already reached BPD status. Among newborns with highest risk of dying, furosemide is indeed the “most frequently used pharmacotherapy,” Dr. Bamat said.

“What’s worth noting is that furosemide is an old medication that has been used extensively in the neonatal populations for 40 years, and that is occurring in the absence of data,” Dr. Bamat added. “This is a very important step forward.”

Dr. Greenberg and Dr. Bamat have disclosed no relevant financial relationships.

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

Caregivers who brought suicidal adolescents to the emergency department reported safer gun storage practices after firearm counseling – a crucial way to cut gun deaths among children, according to researchers from Cincinnati Children’s Hospital.

In the study, which took place between June 2021 and Feb 2022, gun safety counseling and handouts were provided to 99 families of children who had come to the ED with mental health problems. A separate set of 101 families in similar situations received counseling and handouts, along with two cable-style gun locks.

Four weeks later, parents in both groups reported an increase in safe storage practices in which they locked away all guns in the household. Those offered only counseling increased safe storage by 7.2% – from 89.9% to 97.1%.

The gains were greater for families that received locks in addition to counseling. The number of those who locked away all guns rose from 82.2% to 98.5% – a 16.3% increase. (Roughly one-third of families in both arms of the study were lost to follow-up, according to the researchers, which left 68 families in each group for analysis.)

Several caregivers in each group reported that guns had been removed entirely from the home, and more than 60% in each group said they had bought additional gun locks to secure their weapons.

“The main point of our study is that just-in-time counseling is very effective in helping these families of children with mental health concerns in securing all their guns, and an emergency department visit is a great time to do that,” said Bijan Ketabchi, MD, a clinical fellow in the division of emergency medicine at Cincinnati Children’s Hospital Medical Center, who presented the findings at the Pediatric Academic Societies annual meeting.

Dr. Ketabchi said his department sees 500-700 children each month with mental health concerns, most commonly depression. The mean age of adolescent patients in the study was 14 years.

Suicide is the second-leading cause of death among children in the United States. Both pediatric suicides and firearm suicides have increased in the past 2 decades, Dr. Ketabchi said. The number of youth suicides who use guns has risen 90% since 2008. One in three U.S. families own a firearm, and 4.6 million children live in a home with loaded, unlocked guns.

Among children aged 17 years and younger who die by firearm suicide, 82% used guns belonging to a family member.
 

The right time for the message

Interventions to encourage safe gun storage – at a time when caregivers are really listening – can be lifesaving, Dr. Ketabchi said.

“We know that counseling is really helpful for these families, because when they come to the emergency department with a concern, they can have a teachable moment,” he said in an interview. “It resonates with them a lot more than it normally would because they have experienced something traumatic.”

The importance of safe gun storage in households with adolescents can’t be overstated, even if the children are not at risk of suicide, said Naoka Carey, a doctoral candidate at Boston College.

Ms. Carey authored an article on the prevalence of handguns among adolescents that will be published in May in Pediatrics.

“Three kinds of harm for adolescents with access to guns are accidental injury, homicide, and suicide,” she said. “Families who own guns don’t always know their teens have access to the guns.”

The problem is getting worse. Ms. Carey and colleagues found that, between 2002 and 2019, the rate of children aged 12-17 who reported carrying handguns increased 41%. Most of them were White, and their families were in high-income brackets. New data show that firearm injuries have become the leading cause of death among youth in the United States, eclipsing auto accidents for the first time.

“Preventing tragedy in your family is more than reason enough to secure guns you have,” she said.

Dr. Ketabchi disclosed no relevant financial relationships.

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

Caregivers who brought suicidal adolescents to the emergency department reported safer gun storage practices after firearm counseling – a crucial way to cut gun deaths among children, according to researchers from Cincinnati Children’s Hospital.

In the study, which took place between June 2021 and Feb 2022, gun safety counseling and handouts were provided to 99 families of children who had come to the ED with mental health problems. A separate set of 101 families in similar situations received counseling and handouts, along with two cable-style gun locks.

Four weeks later, parents in both groups reported an increase in safe storage practices in which they locked away all guns in the household. Those offered only counseling increased safe storage by 7.2% – from 89.9% to 97.1%.

The gains were greater for families that received locks in addition to counseling. The number of those who locked away all guns rose from 82.2% to 98.5% – a 16.3% increase. (Roughly one-third of families in both arms of the study were lost to follow-up, according to the researchers, which left 68 families in each group for analysis.)

Several caregivers in each group reported that guns had been removed entirely from the home, and more than 60% in each group said they had bought additional gun locks to secure their weapons.

“The main point of our study is that just-in-time counseling is very effective in helping these families of children with mental health concerns in securing all their guns, and an emergency department visit is a great time to do that,” said Bijan Ketabchi, MD, a clinical fellow in the division of emergency medicine at Cincinnati Children’s Hospital Medical Center, who presented the findings at the Pediatric Academic Societies annual meeting.

Dr. Ketabchi said his department sees 500-700 children each month with mental health concerns, most commonly depression. The mean age of adolescent patients in the study was 14 years.

Suicide is the second-leading cause of death among children in the United States. Both pediatric suicides and firearm suicides have increased in the past 2 decades, Dr. Ketabchi said. The number of youth suicides who use guns has risen 90% since 2008. One in three U.S. families own a firearm, and 4.6 million children live in a home with loaded, unlocked guns.

Among children aged 17 years and younger who die by firearm suicide, 82% used guns belonging to a family member.
 

The right time for the message

Interventions to encourage safe gun storage – at a time when caregivers are really listening – can be lifesaving, Dr. Ketabchi said.

“We know that counseling is really helpful for these families, because when they come to the emergency department with a concern, they can have a teachable moment,” he said in an interview. “It resonates with them a lot more than it normally would because they have experienced something traumatic.”

The importance of safe gun storage in households with adolescents can’t be overstated, even if the children are not at risk of suicide, said Naoka Carey, a doctoral candidate at Boston College.

Ms. Carey authored an article on the prevalence of handguns among adolescents that will be published in May in Pediatrics.

“Three kinds of harm for adolescents with access to guns are accidental injury, homicide, and suicide,” she said. “Families who own guns don’t always know their teens have access to the guns.”

The problem is getting worse. Ms. Carey and colleagues found that, between 2002 and 2019, the rate of children aged 12-17 who reported carrying handguns increased 41%. Most of them were White, and their families were in high-income brackets. New data show that firearm injuries have become the leading cause of death among youth in the United States, eclipsing auto accidents for the first time.

“Preventing tragedy in your family is more than reason enough to secure guns you have,” she said.

Dr. Ketabchi disclosed no relevant financial relationships.

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

Caregivers who brought suicidal adolescents to the emergency department reported safer gun storage practices after firearm counseling – a crucial way to cut gun deaths among children, according to researchers from Cincinnati Children’s Hospital.

In the study, which took place between June 2021 and Feb 2022, gun safety counseling and handouts were provided to 99 families of children who had come to the ED with mental health problems. A separate set of 101 families in similar situations received counseling and handouts, along with two cable-style gun locks.

Four weeks later, parents in both groups reported an increase in safe storage practices in which they locked away all guns in the household. Those offered only counseling increased safe storage by 7.2% – from 89.9% to 97.1%.

The gains were greater for families that received locks in addition to counseling. The number of those who locked away all guns rose from 82.2% to 98.5% – a 16.3% increase. (Roughly one-third of families in both arms of the study were lost to follow-up, according to the researchers, which left 68 families in each group for analysis.)

Several caregivers in each group reported that guns had been removed entirely from the home, and more than 60% in each group said they had bought additional gun locks to secure their weapons.

“The main point of our study is that just-in-time counseling is very effective in helping these families of children with mental health concerns in securing all their guns, and an emergency department visit is a great time to do that,” said Bijan Ketabchi, MD, a clinical fellow in the division of emergency medicine at Cincinnati Children’s Hospital Medical Center, who presented the findings at the Pediatric Academic Societies annual meeting.

Dr. Ketabchi said his department sees 500-700 children each month with mental health concerns, most commonly depression. The mean age of adolescent patients in the study was 14 years.

Suicide is the second-leading cause of death among children in the United States. Both pediatric suicides and firearm suicides have increased in the past 2 decades, Dr. Ketabchi said. The number of youth suicides who use guns has risen 90% since 2008. One in three U.S. families own a firearm, and 4.6 million children live in a home with loaded, unlocked guns.

Among children aged 17 years and younger who die by firearm suicide, 82% used guns belonging to a family member.
 

The right time for the message

Interventions to encourage safe gun storage – at a time when caregivers are really listening – can be lifesaving, Dr. Ketabchi said.

“We know that counseling is really helpful for these families, because when they come to the emergency department with a concern, they can have a teachable moment,” he said in an interview. “It resonates with them a lot more than it normally would because they have experienced something traumatic.”

The importance of safe gun storage in households with adolescents can’t be overstated, even if the children are not at risk of suicide, said Naoka Carey, a doctoral candidate at Boston College.

Ms. Carey authored an article on the prevalence of handguns among adolescents that will be published in May in Pediatrics.

“Three kinds of harm for adolescents with access to guns are accidental injury, homicide, and suicide,” she said. “Families who own guns don’t always know their teens have access to the guns.”

The problem is getting worse. Ms. Carey and colleagues found that, between 2002 and 2019, the rate of children aged 12-17 who reported carrying handguns increased 41%. Most of them were White, and their families were in high-income brackets. New data show that firearm injuries have become the leading cause of death among youth in the United States, eclipsing auto accidents for the first time.

“Preventing tragedy in your family is more than reason enough to secure guns you have,” she said.

Dr. Ketabchi disclosed no relevant financial relationships.

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

Stem cell therapy improves motor impairment and is safe and well tolerated in patients with traumatic brain injury (TBI), results from a phase 2 trial indicate. “We proved for the first time that we can affect outcomes in moderately to severely disabled patients with TBI using stem cells,” said study investigator Peter McAllister, MD, cofounder and medical director of the New England Center for Neurology and Headache, Stamford, Conn.

“I think the potential of regenerative medicine was always out there, but we are now getting to the point where we’re living up to that potential,” said Dr. McAllister, associate professor of neurology at Yale University, New Haven, Conn.

The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

No effective treatment to date

TBI can lead to motor deficits and chronic disability and currently there are no effective drugs to treat these deficits.

Researchers are increasingly focused on using somatic stem cells to restore lost function. Stem cells can differentiate or proliferate into different types of cells and are thought to promote repair and regeneration of tissues or organs damaged due to illness or injury.

The study included 61 patients with TBI with an average age of 34 years (70% were male and 69% were White). The mean time from injury was 8 years and Glasgow Outcome Scale Extended (GOS-E) ranged from 3 to 6.

Forty-six participants were randomly assigned to receive the stem cell therapy and 15 a sham procedure. In the treatment group, there were three different doses of cells (2.5 x 106, 5 x 106, and 10 x 106).

The treatment involved an investigational regenerative cell medicine comprised of bone marrow-derived mesenchymal stem cells (SB623). The allogeneic cells came from a male donor.

For the 20-minute procedure, a neurosurgeon drilled a tiny hole in the skull and, guided by MRI, injected the stem cells into the area of the lesion.

Patients receiving a surgical sham procedure were brought to the operating room, anesthetized, and had a hole drilled into the head over the area of the lesion. However, the surgeon went only halfway through the skull bone.

Participants were instructed to do specific physiotherapy exercises at home every morning and afternoon for the first 6 months of the study.

The primary efficacy endpoint was change in the Fugl-Meyer Motor Scale score (FMMS). This scale is widely used for clinical assessment of motor function, including range of motion, walking, lower limb movement, and dexterity.

At 24 weeks, the change in FMMS score for SB623-treated patients (least square [LS] mean increase 8.3) compared with controls (LS increase 2.3) was significant (P = .04).

“When we looked at all the data at 6 months, the folks who got the stem cells did statistically significantly better than the group that got the sham,” and that improvement began within the first week or two, said Dr. McAllister.
 

‘A real impact’

The treatment had a real impact on people’s lives, he said. “Some who couldn’t move their arm at all were able to put a nut on a bolt or brush their teeth, and some were able to button and unbutton where they couldn’t do that before.”

One teenager who was previously completely aphasic spoke an entire sentence.

The middle dose (5 x 106) had “by far” the best outcome, said Dr. McAllister. It’s not yet known whether the improvements will be permanent, he added.

At 48 weeks, treated patients experienced improvement over controls in secondary endpoints of the Action Research Arm Test (ARAT), which assesses grasp, grip, pinch, and gross movements; Gait Velocity (walking 10 meters); and NeuroQOL, a self-report measure of ability to carry out various activities.

However, although these endpoints were all numerically better in the stem cell groups, none reached statistical significance. This is likely because of the small study size and the fact the control group improved so much, said Dr. McAllister.

The exact mechanism of stem cell therapy is unclear, but researchers believe it “establishes a milieu of growth” for cells in the brain and promotes anti-inflammatory properties, said Dr. McAllister.

By 48 weeks, all study subjects had experienced at least one adverse event, with no differences between groups and no patient withdrawing as a result of adverse events. “There was no safety signal at all related to the stem cells,” said Dr. McAllister.

A larger phase 3 study of SB623 is planned.

The treatment may be useful in other conditions. A study of stroke survivors “just barely missed statistical significance” likely for methodological reasons and an older, sicker population, but the company plans to do another study in patients who were affected by stroke, said Dr. McAllister.

In addition, there may be potential for this approach with brain hemorrhage, Parkinson’s disease, multiple sclerosis, and other brain-related disorders, he said.
 

‘Modern-day holy grail’

Reached for a comment, TBI specialist Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology, said stem cell therapy is the most promising potential treatment for brain injury. “It’s the modern-day ‘holy grail.’ “

In this study, “to see a modest improvement in gait in the primary outcome is impressive,” he said.

In addition, the fact the study didn’t have any significant or severe adverse outcomes “is promising,” he added.

Studies like this “are going to help to lay the groundwork for future studies and hopefully one day result in a safe, noninvasive treatment” for Parkinson’s disease, Alzheimer’s disease, and disorders that affect the central nervous system such as spinal cord injury, Dr. Conidi said.

This therapy involves an invasive procedure requiring implantation directly into the brain, he noted. “At present, there’s no way to get stem cells to cross the blood-brain barrier.”

In addition, although motor impairment is definitely a component of TBI, it’s not as prevalent as cognitive impairment, said Dr. Conidi.

The study was supported by SanBio Co Ltd. Dr. McAllister and Dr. Conidi have disclosed no relevant financial relationships.

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

Stem cell therapy improves motor impairment and is safe and well tolerated in patients with traumatic brain injury (TBI), results from a phase 2 trial indicate. “We proved for the first time that we can affect outcomes in moderately to severely disabled patients with TBI using stem cells,” said study investigator Peter McAllister, MD, cofounder and medical director of the New England Center for Neurology and Headache, Stamford, Conn.

“I think the potential of regenerative medicine was always out there, but we are now getting to the point where we’re living up to that potential,” said Dr. McAllister, associate professor of neurology at Yale University, New Haven, Conn.

The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

No effective treatment to date

TBI can lead to motor deficits and chronic disability and currently there are no effective drugs to treat these deficits.

Researchers are increasingly focused on using somatic stem cells to restore lost function. Stem cells can differentiate or proliferate into different types of cells and are thought to promote repair and regeneration of tissues or organs damaged due to illness or injury.

The study included 61 patients with TBI with an average age of 34 years (70% were male and 69% were White). The mean time from injury was 8 years and Glasgow Outcome Scale Extended (GOS-E) ranged from 3 to 6.

Forty-six participants were randomly assigned to receive the stem cell therapy and 15 a sham procedure. In the treatment group, there were three different doses of cells (2.5 x 106, 5 x 106, and 10 x 106).

The treatment involved an investigational regenerative cell medicine comprised of bone marrow-derived mesenchymal stem cells (SB623). The allogeneic cells came from a male donor.

For the 20-minute procedure, a neurosurgeon drilled a tiny hole in the skull and, guided by MRI, injected the stem cells into the area of the lesion.

Patients receiving a surgical sham procedure were brought to the operating room, anesthetized, and had a hole drilled into the head over the area of the lesion. However, the surgeon went only halfway through the skull bone.

Participants were instructed to do specific physiotherapy exercises at home every morning and afternoon for the first 6 months of the study.

The primary efficacy endpoint was change in the Fugl-Meyer Motor Scale score (FMMS). This scale is widely used for clinical assessment of motor function, including range of motion, walking, lower limb movement, and dexterity.

At 24 weeks, the change in FMMS score for SB623-treated patients (least square [LS] mean increase 8.3) compared with controls (LS increase 2.3) was significant (P = .04).

“When we looked at all the data at 6 months, the folks who got the stem cells did statistically significantly better than the group that got the sham,” and that improvement began within the first week or two, said Dr. McAllister.
 

‘A real impact’

The treatment had a real impact on people’s lives, he said. “Some who couldn’t move their arm at all were able to put a nut on a bolt or brush their teeth, and some were able to button and unbutton where they couldn’t do that before.”

One teenager who was previously completely aphasic spoke an entire sentence.

The middle dose (5 x 106) had “by far” the best outcome, said Dr. McAllister. It’s not yet known whether the improvements will be permanent, he added.

At 48 weeks, treated patients experienced improvement over controls in secondary endpoints of the Action Research Arm Test (ARAT), which assesses grasp, grip, pinch, and gross movements; Gait Velocity (walking 10 meters); and NeuroQOL, a self-report measure of ability to carry out various activities.

However, although these endpoints were all numerically better in the stem cell groups, none reached statistical significance. This is likely because of the small study size and the fact the control group improved so much, said Dr. McAllister.

The exact mechanism of stem cell therapy is unclear, but researchers believe it “establishes a milieu of growth” for cells in the brain and promotes anti-inflammatory properties, said Dr. McAllister.

By 48 weeks, all study subjects had experienced at least one adverse event, with no differences between groups and no patient withdrawing as a result of adverse events. “There was no safety signal at all related to the stem cells,” said Dr. McAllister.

A larger phase 3 study of SB623 is planned.

The treatment may be useful in other conditions. A study of stroke survivors “just barely missed statistical significance” likely for methodological reasons and an older, sicker population, but the company plans to do another study in patients who were affected by stroke, said Dr. McAllister.

In addition, there may be potential for this approach with brain hemorrhage, Parkinson’s disease, multiple sclerosis, and other brain-related disorders, he said.
 

‘Modern-day holy grail’

Reached for a comment, TBI specialist Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology, said stem cell therapy is the most promising potential treatment for brain injury. “It’s the modern-day ‘holy grail.’ “

In this study, “to see a modest improvement in gait in the primary outcome is impressive,” he said.

In addition, the fact the study didn’t have any significant or severe adverse outcomes “is promising,” he added.

Studies like this “are going to help to lay the groundwork for future studies and hopefully one day result in a safe, noninvasive treatment” for Parkinson’s disease, Alzheimer’s disease, and disorders that affect the central nervous system such as spinal cord injury, Dr. Conidi said.

This therapy involves an invasive procedure requiring implantation directly into the brain, he noted. “At present, there’s no way to get stem cells to cross the blood-brain barrier.”

In addition, although motor impairment is definitely a component of TBI, it’s not as prevalent as cognitive impairment, said Dr. Conidi.

The study was supported by SanBio Co Ltd. Dr. McAllister and Dr. Conidi have disclosed no relevant financial relationships.

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

Stem cell therapy improves motor impairment and is safe and well tolerated in patients with traumatic brain injury (TBI), results from a phase 2 trial indicate. “We proved for the first time that we can affect outcomes in moderately to severely disabled patients with TBI using stem cells,” said study investigator Peter McAllister, MD, cofounder and medical director of the New England Center for Neurology and Headache, Stamford, Conn.

“I think the potential of regenerative medicine was always out there, but we are now getting to the point where we’re living up to that potential,” said Dr. McAllister, associate professor of neurology at Yale University, New Haven, Conn.

The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
 

No effective treatment to date

TBI can lead to motor deficits and chronic disability and currently there are no effective drugs to treat these deficits.

Researchers are increasingly focused on using somatic stem cells to restore lost function. Stem cells can differentiate or proliferate into different types of cells and are thought to promote repair and regeneration of tissues or organs damaged due to illness or injury.

The study included 61 patients with TBI with an average age of 34 years (70% were male and 69% were White). The mean time from injury was 8 years and Glasgow Outcome Scale Extended (GOS-E) ranged from 3 to 6.

Forty-six participants were randomly assigned to receive the stem cell therapy and 15 a sham procedure. In the treatment group, there were three different doses of cells (2.5 x 106, 5 x 106, and 10 x 106).

The treatment involved an investigational regenerative cell medicine comprised of bone marrow-derived mesenchymal stem cells (SB623). The allogeneic cells came from a male donor.

For the 20-minute procedure, a neurosurgeon drilled a tiny hole in the skull and, guided by MRI, injected the stem cells into the area of the lesion.

Patients receiving a surgical sham procedure were brought to the operating room, anesthetized, and had a hole drilled into the head over the area of the lesion. However, the surgeon went only halfway through the skull bone.

Participants were instructed to do specific physiotherapy exercises at home every morning and afternoon for the first 6 months of the study.

The primary efficacy endpoint was change in the Fugl-Meyer Motor Scale score (FMMS). This scale is widely used for clinical assessment of motor function, including range of motion, walking, lower limb movement, and dexterity.

At 24 weeks, the change in FMMS score for SB623-treated patients (least square [LS] mean increase 8.3) compared with controls (LS increase 2.3) was significant (P = .04).

“When we looked at all the data at 6 months, the folks who got the stem cells did statistically significantly better than the group that got the sham,” and that improvement began within the first week or two, said Dr. McAllister.
 

‘A real impact’

The treatment had a real impact on people’s lives, he said. “Some who couldn’t move their arm at all were able to put a nut on a bolt or brush their teeth, and some were able to button and unbutton where they couldn’t do that before.”

One teenager who was previously completely aphasic spoke an entire sentence.

The middle dose (5 x 106) had “by far” the best outcome, said Dr. McAllister. It’s not yet known whether the improvements will be permanent, he added.

At 48 weeks, treated patients experienced improvement over controls in secondary endpoints of the Action Research Arm Test (ARAT), which assesses grasp, grip, pinch, and gross movements; Gait Velocity (walking 10 meters); and NeuroQOL, a self-report measure of ability to carry out various activities.

However, although these endpoints were all numerically better in the stem cell groups, none reached statistical significance. This is likely because of the small study size and the fact the control group improved so much, said Dr. McAllister.

The exact mechanism of stem cell therapy is unclear, but researchers believe it “establishes a milieu of growth” for cells in the brain and promotes anti-inflammatory properties, said Dr. McAllister.

By 48 weeks, all study subjects had experienced at least one adverse event, with no differences between groups and no patient withdrawing as a result of adverse events. “There was no safety signal at all related to the stem cells,” said Dr. McAllister.

A larger phase 3 study of SB623 is planned.

The treatment may be useful in other conditions. A study of stroke survivors “just barely missed statistical significance” likely for methodological reasons and an older, sicker population, but the company plans to do another study in patients who were affected by stroke, said Dr. McAllister.

In addition, there may be potential for this approach with brain hemorrhage, Parkinson’s disease, multiple sclerosis, and other brain-related disorders, he said.
 

‘Modern-day holy grail’

Reached for a comment, TBI specialist Frank Conidi, MD, director of the Florida Center for Headache and Sports Neurology, said stem cell therapy is the most promising potential treatment for brain injury. “It’s the modern-day ‘holy grail.’ “

In this study, “to see a modest improvement in gait in the primary outcome is impressive,” he said.

In addition, the fact the study didn’t have any significant or severe adverse outcomes “is promising,” he added.

Studies like this “are going to help to lay the groundwork for future studies and hopefully one day result in a safe, noninvasive treatment” for Parkinson’s disease, Alzheimer’s disease, and disorders that affect the central nervous system such as spinal cord injury, Dr. Conidi said.

This therapy involves an invasive procedure requiring implantation directly into the brain, he noted. “At present, there’s no way to get stem cells to cross the blood-brain barrier.”

In addition, although motor impairment is definitely a component of TBI, it’s not as prevalent as cognitive impairment, said Dr. Conidi.

The study was supported by SanBio Co Ltd. Dr. McAllister and Dr. Conidi have disclosed no relevant financial relationships.

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

BOSTON – When patients present with complaints of hair loss or changes in hair color or texture, make sure to ask if they are taking oral hair growth supplements.

This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.

Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”

In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.

Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?

Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.

Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.

Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.

Dr. Bergfeld noted that biotin, also known as vitamin B₇ and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”

To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B₁₂ for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.

While there are not enough data to support a recommendation for supplementation of folic or B₁₂ for alopecia, she said, “vitamin B₁₂ deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”

She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”

Dr. Bergfeld reported having no disclosures related to her presentation.

BOSTON – When patients present with complaints of hair loss or changes in hair color or texture, make sure to ask if they are taking oral hair growth supplements.

This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.

Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”

In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.

Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?

Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.

Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.

Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.

Dr. Bergfeld noted that biotin, also known as vitamin B₇ and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”

To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B₁₂ for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.

While there are not enough data to support a recommendation for supplementation of folic or B₁₂ for alopecia, she said, “vitamin B₁₂ deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”

She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”

Dr. Bergfeld reported having no disclosures related to her presentation.

BOSTON – When patients present with complaints of hair loss or changes in hair color or texture, make sure to ask if they are taking oral hair growth supplements.

This is an important question because patients consider supplements as “natural and healthy,” not as drugs or chemicals, Wilma F. Bergfeld, MD, said at the annual meeting of the American Academy of Dermatology.

Some of these products contain botanicals, which are not always safe, added Dr. Bergfeld, professor of dermatology and pathology at the Cleveland Clinic. “They have many activities, and they are being touted as having some activity in helping the hair or enhancing hair growth,” including having 5-alpha-reductase inhibitors as an ingredient. “Saw palmetto is probably the most common one, but there are a host of natural ingredients that are being put into these supplements, including those that promote androgen induction, as well as antioxidants and anti-inflammatories.”

In the opinion of Dr. Bergfeld, a nutrition-focused physical assessment should include an examination of the scalp and all hairy areas. “It’s also important to see the symmetry and shape of hair growth or hair loss areas, the distribution, hair color, the thickness and texture of the hair fibers,” she added.

Besides asking about what supplements patients are taking, other questions to ask during the visit include: Are you noticing more hair on your brush, pillow, and shoulders, or in the shower? Do you think your hair is thinning? What are your medical problems? Have you experienced rapid weight loss? Have you started any new medications? What medication(s) are you on? What foods do you eat? Do you have a family history of hair loss?

Possible causes of hair loss or changes include environmental factors, stress, hormonal changes, medications, and nutrition.

Common ingredients contained in healthy hair supplements include biotin, folic acid, L-cysteine, L-methionine, MSM (methylsulfonylmethane), vitamin B complex, and vitamins A, C, D, and E. “Vitamin D and A are associated on the hair follicle receptor sites, and they balance each other, so if one is down the other is usually down,” said Dr. Bergfeld, who directs Cleveland Clinic’s hair disorders clinic and its dermatopathology program. Other important ingredients include iron, zinc, manganese, amino acids including L-Lysine, and fatty acids.

Iron deficiency is a known cause of hair loss. “The absorption of iron relies on vitamin C and sometimes lysine,” she said. Red meat has a high iron content and since many patients are restricting red meat intake, “they do need to think about that.” Zinc deficiency is less common in Western countries, she continued, “but when you find it, it’s revolutionary because if they’re shedding hair and their hair character is changing, often some supplementation will do the trick. But remember: Zinc is not only an anti-inflammatory, it’s also an antiandrogen. It has 5-alpha-reductase inhibitor capabilities.”.

Dr. Bergfeld noted that biotin, also known as vitamin B₇ and found in many foods, is used in many vitamin supplements marketed for hair loss. The recommended daily allowance (RDA) is 30 mcg/day in adults but the amount in hair supplements can be up to 650% of RDA. “Biotin at high levels is believed to be safe, but can interfere with troponin and other lab testing,” she cautioned. “This can lead to dangerous false laboratory results.”

To date, insufficient data exist to recommend supplementation with zinc, riboflavin, folic acid, or vitamin B₁₂ for hair loss, “but they may help in cases of deficiency,” said Dr. Bergfeld, a past president of the American Hair Research Society. The use of vitamin E and biotin supplementation is not supported in the literature for treating androgenetic alopecia or telogen effluvium. Excessive vitamin A (not beta carotene) and selenium can contribute to hair loss and studies have shown a relationship between androgenetic alopecia and low vitamin D levels. “Vitamin D should be supplemented if serum levels are low, but more studies are needed to determine the effect of iron and zinc supplementation” in patients with androgenetic alopecia, she said.

While there are not enough data to support a recommendation for supplementation of folic or B₁₂ for alopecia, she said, “vitamin B₁₂ deficiency may occur in androgenetic alopecia patients, associated with pernicious anemia.”

She added that the use biotin supplementation for the treatment of androgenetic alopecia is not supported by available data, and “it is also unclear if selenium plays a role in this disease.”

Dr. Bergfeld reported having no disclosures related to her presentation.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

SAN FRANCISCO – Endoscopic treatments for obesity are under-utilized but represent an opportunity for gastroenterologists to help address the metabolic epidemic that affects up to 40% of people in the United States, according to a presentation reviewing these techniques.

Lifestyle modification is the first intervention, but results in just a 5% average weight loss, according to Allison Schulman, MD, MPH, who discussed these options at the 2022 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. Although surgical interventions induce more weight loss and greater improvement of metabolic outcomes, they come with significant risks and many patients are reluctant to pursue them, she added. In fact, fewer than 1% of obese individuals who qualify for bariatric surgery ultimately undergo it.

Dr. Schulman emphasized another option: Endoscopic bariatric therapies fill this void in between those two extremes, as they are clearly less invasive” said Dr. Schulman, who is an assistant professor of gastroenterology and hepatology at the University of Michigan, Ann Arbor. “They may appeal to those who do not qualify or do not want bariatric surgery. They also could bridge a critical gap in the treatment of obesity, as they reach patients earlier, at BMIs [body mass indexes] where they may not be surgical candidates. Furthermore, these therapies are oftentimes repeatable and commonly can be used in combination [with other weight loss approaches].”

Endoscopic therapies for obesity include devices that occupy space in the stomach, such as intragastric balloons, gastric remodeling procedures like endoscopic sleeve gastroplasty (ESG), and aspiration therapy.

Potential candidates for noninvasive approaches include patients with a BMI over 30 kg/m² who have not lost sufficient weight through nonsurgical methods or those who do not want to undergo surgery or require a bridge therapy to surgery.

Fluid-filled balloons can be placed and filled to an appropriate volume. One network meta-analysis found that fluid-filled balloons were more likely to lead to weight loss, but also more likely to be removed due to intolerance. She also noted that the Elipse balloon (Allurion Technologies) is designed to be swallowed and thus avoid procedures entirely; it is currently under review by Food and Drug Administration.

Although balloons are linked to 7%-10% weight loss in some studies and reviews, Dr. Schulman said, “we know … that the majority of these lead to much more weight loss in clinical practice, oftentimes closer to 13%-%15.”

One review found that balloons also lead to improvement in obesity-related comorbidities, compared with conventional nonsurgical approaches, and this benefit extends past 1 year. A study of 21 patients with nonalcoholic steatohepatitis (NASH) treated with intragastric balloons found that 90% had an improvement in nonalcoholic fatty liver disease activity score, with a median drop of 3 points, and 80% had a drop of at least 2 points. Of these patients, 50% also had an improvement in fibrosis determined by magnetic resonance elastography.

Balloon therapy should be highly individualized, according to Dr. Schulman.

Dr. Schulman also described ESG, which uses sutures to remodel the stomach and reduce volume by up to 70%. She outlined studies and reviews, such as those from Sharaiha and colleagues and Hedjoudje and colleagues, showing that ESG leads to significant and sustained weight loss. The procedure was also quite safe, with one large, single-center study showing that both fever and significant blood loss each occurred in less than 1% of patients (Gastrointest Endosc. 2019 Jun;89[6]:1132-8), while the systematic review and meta-analysis from Hedjoudje and colleagues found an adverse event frequency of 2.2%.

In a matched control study, laparoscopic sleeve gastrectomy led to more weight loss, but ESG had fewer adverse events (5.2% versus 16.9%; P < .01) and had a greater effect on gastroesophageal reflux disease.

ESG can be effective when repeated, while surgical revisions are associated with much higher morbidity, according to Dr. Schulman.

During her presentation, Dr. Schulman mentioned the AspireAssist device developed by Aspire Bariatrics, which is similar to a percutaneous endoscopic gastrostomy (PEG) tube. It leads to the removal of about 30% of calories consumed during a meal, with patients instructed to aspirate 20-30 minutes after a meal, two to three times a day. It gained Food and Drug Administration approval on the strength of the PATHWAY study, which showed significant weight loss.

“But perhaps more impressive is the overall patient satisfaction and willingness to recommend this device to others,” said Dr. Schulman.

Another approach she described is the transpyloric shuttle (TPS), which leads to faster filling times and delayed gastric emptying, though it must be removed endoscopically at 12 months.

Dr. Schulman also discussed endoscopic bariatric and metabolic therapy. This approach is currently a primary therapy for obesity, and is in development for the treatment of diabetes and non-alcoholic fatty liver disease. The approach is predicated on the idea that obesity is a disorder of energy homeostasis, and that enteric neurons in the small bowel are key players, possibly through reduced production of as yet unknown signaling molecules, leading to insulin resistance. It’s also known that diets high in fat and sugar alter the duodenum, which causes changes in nutrient signaling to the brain.

“It’s thought that this leads to duodenal endocrine hyperactivity and ultimately metabolic disease,” said Dr. Schulman.

Finally, she described small-bowel therapies like endobarrier sleeves, duodenal mucosal resurfacing, and an incisionless anastomosis system designed to improve glycemic control by altering the gut through noninvasive means.

Dr. Schulman has consulted for Apollo Endosurgery, Boston Scientific, Olympus, and MicroTech, and has received research support from GI Dynamics.

High rates of antipsychotic switching in first episode psychosis (FEP) suggests first-line prescribing is less than optimal and does not follow recent clinical guidance.

In a large-scale, real-world analysis of U.K. prescribing patterns, researchers found more than two-thirds of patients who received antipsychotics for FEP switched medication, and almost half switched drugs three times.

VladimirSorokin/Getty Images

Although this is “one of the largest real-world studies examining antipsychotic treatment strategies,” it reflects findings from previous, smaller studies showing “antipsychotic switching in first episode psychosis is high,” said study investigator Aimee Brinn, Institute of Psychiatry, Psychology & Neuroscience at King’s College London.

This may reflect reports of poor efficacy and suggests that first-line prescribing is “suboptimal,” Ms. Brinn noted. In addition, olanzapine remains the most popular antipsychotic for prescribing despite recent guidelines indicating it is “not ideal ... due to its dangerous metabolic side effects,” she added.

The findings were presented at the Congress of the Schizophrenia International Research Society (SIRS) 2022.
 

Real-world data

The response to, and tolerability of, antipsychotics differs between patients with FEP; and prescribing patterns “reflect clinician and patient-led decisionmaking,” Ms. Brinn told meeting attendees.

Since randomized controlled trials “do not necessarily reflect prescribing practice in real-world clinical settings,” the researchers gathered data from a large mental health care electronic health record dataset.

The investigators examined records from the South London and Maudsley NHS Foundation Trust (SLaM), which has a catchment area of 1.2 million individuals across four boroughs of London. The group sees approximately 37,500 active patients per week.

The team used the Clinical Interactive Record Search tool to extract data on 2,309 adults with FEP who received care from a SLaM early intervention in psychosis service between April 1, 2008, and March 31, 2019.

They found that 12 different antipsychotics were prescribed as first-line treatment. The most common were olanzapine (43.9%), risperidone (24.7%), and aripiprazole (19.9%).

Results showed that over 81,969.5 person-years of follow-up, at a minimum of 24 months per patient, 68.8% had an antipsychotic switch. The most common first treatment switch, in 17.9% of patients, was from olanzapine to aripiprazole.

Of patients who switched to aripiprazole, 48.4% stayed on the drug, 26% switched back to olanzapine, and 25.6% received other treatment. Overall, 44.7% of patients switched medication at least three times.

Among patients with FEP who did not switch, 42.2% were prescribed olanzapine, 26.2% risperidone, 23.3% aripiprazole, 5.6% quetiapine, and 2.7% amisulpride.

During the post-presentation discussion, Ms. Brinn was asked whether the high rate of first-line olanzapine prescribing could be because patients started treatment as inpatients and were then switched once they were moved to community care.

“We found that a lot of patients would be prescribed olanzapine for around 7 days at the start of their prescription and then switch,” Ms. Brinn said, adding it is “likely” they started as inpatients. The investigators are currently examining the differences between inpatient and outpatient prescriptions to verify whether this is indeed the case, she added.
 

‘Pulling out the big guns too fast?’

Commenting on the findings, Thomas W. Sedlak, MD, PhD, Johns Hopkins University School of Medicine, Baltimore, said the study raises a “number of questions.”

Both olanzapine and risperidone “tend to have higher treatment effect improvements than aripiprazole, so it’s curious that a switch to aripiprazole was common,” said Dr. Sedlak, who was not involved with the research.

“Are we pulling out the ‘big guns’ too fast, or inappropriately, especially as olanzapine and risperidone carry greater risk of weight gain?” he asked. In addition, “now that olanzapine is available with samidorphan to mitigate weight gain, will that shape future patterns, if it can be paid for?”

Dr. Sedlak noted it was unclear why olanzapine was chosen so often as first-line treatment in the study and agreed it is “possible that hospitalized patients had been prescribed a ‘stronger’ medication like olanzapine compared to never-hospitalized patients.”

He also underlined that it is “not clear if patients in this FEP program are representative of all FEP patients.”

“For instance, if the program is well known to inpatient hospital social workers, then the program might be disproportionately filled with patients who have had more severe symptoms,” Dr. Sedlak said.

The study was supported by Janssen-Cilag. The investigators and Dr. Sedlak have disclosed no relevant financial relationships.

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

High rates of antipsychotic switching in first episode psychosis (FEP) suggests first-line prescribing is less than optimal and does not follow recent clinical guidance.

In a large-scale, real-world analysis of U.K. prescribing patterns, researchers found more than two-thirds of patients who received antipsychotics for FEP switched medication, and almost half switched drugs three times.

VladimirSorokin/Getty Images

Although this is “one of the largest real-world studies examining antipsychotic treatment strategies,” it reflects findings from previous, smaller studies showing “antipsychotic switching in first episode psychosis is high,” said study investigator Aimee Brinn, Institute of Psychiatry, Psychology & Neuroscience at King’s College London.

This may reflect reports of poor efficacy and suggests that first-line prescribing is “suboptimal,” Ms. Brinn noted. In addition, olanzapine remains the most popular antipsychotic for prescribing despite recent guidelines indicating it is “not ideal ... due to its dangerous metabolic side effects,” she added.

The findings were presented at the Congress of the Schizophrenia International Research Society (SIRS) 2022.
 

Real-world data

The response to, and tolerability of, antipsychotics differs between patients with FEP; and prescribing patterns “reflect clinician and patient-led decisionmaking,” Ms. Brinn told meeting attendees.

Since randomized controlled trials “do not necessarily reflect prescribing practice in real-world clinical settings,” the researchers gathered data from a large mental health care electronic health record dataset.

The investigators examined records from the South London and Maudsley NHS Foundation Trust (SLaM), which has a catchment area of 1.2 million individuals across four boroughs of London. The group sees approximately 37,500 active patients per week.

The team used the Clinical Interactive Record Search tool to extract data on 2,309 adults with FEP who received care from a SLaM early intervention in psychosis service between April 1, 2008, and March 31, 2019.

They found that 12 different antipsychotics were prescribed as first-line treatment. The most common were olanzapine (43.9%), risperidone (24.7%), and aripiprazole (19.9%).

Results showed that over 81,969.5 person-years of follow-up, at a minimum of 24 months per patient, 68.8% had an antipsychotic switch. The most common first treatment switch, in 17.9% of patients, was from olanzapine to aripiprazole.

Of patients who switched to aripiprazole, 48.4% stayed on the drug, 26% switched back to olanzapine, and 25.6% received other treatment. Overall, 44.7% of patients switched medication at least three times.

Among patients with FEP who did not switch, 42.2% were prescribed olanzapine, 26.2% risperidone, 23.3% aripiprazole, 5.6% quetiapine, and 2.7% amisulpride.

During the post-presentation discussion, Ms. Brinn was asked whether the high rate of first-line olanzapine prescribing could be because patients started treatment as inpatients and were then switched once they were moved to community care.

“We found that a lot of patients would be prescribed olanzapine for around 7 days at the start of their prescription and then switch,” Ms. Brinn said, adding it is “likely” they started as inpatients. The investigators are currently examining the differences between inpatient and outpatient prescriptions to verify whether this is indeed the case, she added.
 

‘Pulling out the big guns too fast?’

Commenting on the findings, Thomas W. Sedlak, MD, PhD, Johns Hopkins University School of Medicine, Baltimore, said the study raises a “number of questions.”

Both olanzapine and risperidone “tend to have higher treatment effect improvements than aripiprazole, so it’s curious that a switch to aripiprazole was common,” said Dr. Sedlak, who was not involved with the research.

“Are we pulling out the ‘big guns’ too fast, or inappropriately, especially as olanzapine and risperidone carry greater risk of weight gain?” he asked. In addition, “now that olanzapine is available with samidorphan to mitigate weight gain, will that shape future patterns, if it can be paid for?”

Dr. Sedlak noted it was unclear why olanzapine was chosen so often as first-line treatment in the study and agreed it is “possible that hospitalized patients had been prescribed a ‘stronger’ medication like olanzapine compared to never-hospitalized patients.”

He also underlined that it is “not clear if patients in this FEP program are representative of all FEP patients.”

“For instance, if the program is well known to inpatient hospital social workers, then the program might be disproportionately filled with patients who have had more severe symptoms,” Dr. Sedlak said.

The study was supported by Janssen-Cilag. The investigators and Dr. Sedlak have disclosed no relevant financial relationships.

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

High rates of antipsychotic switching in first episode psychosis (FEP) suggests first-line prescribing is less than optimal and does not follow recent clinical guidance.

In a large-scale, real-world analysis of U.K. prescribing patterns, researchers found more than two-thirds of patients who received antipsychotics for FEP switched medication, and almost half switched drugs three times.

VladimirSorokin/Getty Images

Although this is “one of the largest real-world studies examining antipsychotic treatment strategies,” it reflects findings from previous, smaller studies showing “antipsychotic switching in first episode psychosis is high,” said study investigator Aimee Brinn, Institute of Psychiatry, Psychology & Neuroscience at King’s College London.

This may reflect reports of poor efficacy and suggests that first-line prescribing is “suboptimal,” Ms. Brinn noted. In addition, olanzapine remains the most popular antipsychotic for prescribing despite recent guidelines indicating it is “not ideal ... due to its dangerous metabolic side effects,” she added.

The findings were presented at the Congress of the Schizophrenia International Research Society (SIRS) 2022.
 

Real-world data

The response to, and tolerability of, antipsychotics differs between patients with FEP; and prescribing patterns “reflect clinician and patient-led decisionmaking,” Ms. Brinn told meeting attendees.

Since randomized controlled trials “do not necessarily reflect prescribing practice in real-world clinical settings,” the researchers gathered data from a large mental health care electronic health record dataset.

The investigators examined records from the South London and Maudsley NHS Foundation Trust (SLaM), which has a catchment area of 1.2 million individuals across four boroughs of London. The group sees approximately 37,500 active patients per week.

The team used the Clinical Interactive Record Search tool to extract data on 2,309 adults with FEP who received care from a SLaM early intervention in psychosis service between April 1, 2008, and March 31, 2019.

They found that 12 different antipsychotics were prescribed as first-line treatment. The most common were olanzapine (43.9%), risperidone (24.7%), and aripiprazole (19.9%).

Results showed that over 81,969.5 person-years of follow-up, at a minimum of 24 months per patient, 68.8% had an antipsychotic switch. The most common first treatment switch, in 17.9% of patients, was from olanzapine to aripiprazole.

Of patients who switched to aripiprazole, 48.4% stayed on the drug, 26% switched back to olanzapine, and 25.6% received other treatment. Overall, 44.7% of patients switched medication at least three times.

Among patients with FEP who did not switch, 42.2% were prescribed olanzapine, 26.2% risperidone, 23.3% aripiprazole, 5.6% quetiapine, and 2.7% amisulpride.

During the post-presentation discussion, Ms. Brinn was asked whether the high rate of first-line olanzapine prescribing could be because patients started treatment as inpatients and were then switched once they were moved to community care.

“We found that a lot of patients would be prescribed olanzapine for around 7 days at the start of their prescription and then switch,” Ms. Brinn said, adding it is “likely” they started as inpatients. The investigators are currently examining the differences between inpatient and outpatient prescriptions to verify whether this is indeed the case, she added.
 

‘Pulling out the big guns too fast?’

Commenting on the findings, Thomas W. Sedlak, MD, PhD, Johns Hopkins University School of Medicine, Baltimore, said the study raises a “number of questions.”

Both olanzapine and risperidone “tend to have higher treatment effect improvements than aripiprazole, so it’s curious that a switch to aripiprazole was common,” said Dr. Sedlak, who was not involved with the research.

“Are we pulling out the ‘big guns’ too fast, or inappropriately, especially as olanzapine and risperidone carry greater risk of weight gain?” he asked. In addition, “now that olanzapine is available with samidorphan to mitigate weight gain, will that shape future patterns, if it can be paid for?”

Dr. Sedlak noted it was unclear why olanzapine was chosen so often as first-line treatment in the study and agreed it is “possible that hospitalized patients had been prescribed a ‘stronger’ medication like olanzapine compared to never-hospitalized patients.”

He also underlined that it is “not clear if patients in this FEP program are representative of all FEP patients.”

“For instance, if the program is well known to inpatient hospital social workers, then the program might be disproportionately filled with patients who have had more severe symptoms,” Dr. Sedlak said.

The study was supported by Janssen-Cilag. The investigators and Dr. Sedlak have disclosed no relevant financial relationships.

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

An overall ninefold increase in COVID-19 antibody levels can be seen with a longer interval between first and second doses of the Pfizer/BioNTech (BNT162b2) vaccine in people without prior infection, according to data from the U.K. government’s SIREN (SARS-CoV-2 Immunity and Reinfection Evaluation) study.

This interval-dependent antibody level varied by age, with those aged 45-54 years showing an 11-fold increase with a longer dosing interval (greater than 10 weeks vs. 2-4 weeks). People younger than age 25 years showed a 13-fold increase with the longer interval, but participant numbers were low in this sub-group.

Overall antibody levels in infection-naive participants were 1,268.72 Binding Antibody Units (BAU)/mL (1,043.25-1,542.91) in those with a 2-4–week interval, compared with 11,479.73 BAU/mL (10,742.78-12,267.24) (P < .0001), in those with at least a 10-week interval between doses.

The work is the latest analysis from SIREN, which measured antibody levels in the blood from nearly 6,000 health care workers from across the United Kingdom. Study lead Ashley Otter, PhD, technical lead for SIREN serology at the UK Health Security Agency (UKHSA), will present the work on Tuesday at the 2022 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), Lisbon.

In an interview, Dr. Otter noted that, “it is important to remember that antibody levels are only one aspect of the immune response, and in our recent vaccine effectiveness analysis, we found that dosing intervals did not affect protection against infection.”

The study, which appeared in the March issue of the New England Journal of Medicine, also found that after the second dose of vaccine, there was about a 2.5–fold difference in antibody levels between those who had prior infection of 16.052 (14.071-18.312) BAU/mL, compared with 7.050 (6.634-7.491) BAU/mL in infection-naive individuals (P < .0001).

Following the first dose only, antibody levels were up to 10 times higher in participants who were previously infected, compared with infection-naive individuals. This effect lasted up to 8 months and then began to plateau.
 

Natural infection increased antibody levels

Dr. Otter remarked that, “COVID-19 antibody levels are high in those people who were previously naturally infected and vaccinated, highlighting that vaccination provides an additional benefit to these individuals.”

This news organization asked Charlotte Thålin, PhD, an immunologist from the Karolinska Institute, Stockholm, to comment on the study. Dr. Thålin studies a cohort similar to SIREN, called the Swedish COMMUNITY health care worker cohort. “The new data from the SIREN emphasizes the importance of the number of antigenic exposures and the time interval between them, whether it be exposure through vaccination or exposure through infection.” 

“We see similar data in our Swedish COMMUNITY health care worker cohort,” Dr. Thålin continued, “where infection prior to vaccination yields a more than twofold enhancement in antibodies, neutralizing breadth, and T cell responses, and an even larger increase with a longer time interval between infection and vaccination.”

However, she cautioned that they now see a high rate of Omicron vaccine breakthrough infections, and this is also true in people with previous infection and three vaccine doses.

“As we approach a second booster – a fourth vaccine dose – we need to consider that many individuals will have had up to five to six antigen exposures within a short period of time, sometimes within a year,” she pointed out. “This is a whole new scenario, with a lot of different combinations of vaccine and infection-induced immunity. We do not yet know the impact of these frequent immune exposures, and we now need to monitor immune responses following Omicron and booster doses closely.”

SIREN originally aimed to understand how much protection people got after developing a primary infection and why they might become reinfected with COVID-19. Following the rollout of the United Kingdom’s vaccination program, the protective effects of vaccination against COVID-19 were investigated, as well as why some people still become ill after being vaccinated, Dr. Otter explained.

In this latest analysis, Dr. Otter and colleagues assessed anti-spike binding antibodies in serum samples from a total of 5,871 health care workers, with 3,989 after one dose (at least 21 days) and 1,882 after two doses (at least 14 days).

Most participants were women (82.3%), of White ethnicity (87%), and came from across the United Kingdom.

Participants were also categorized into those who had evidence of natural COVID-19 infection (confirmed by a PCR test or assumed because of their antibody profile) or those who were infection-naive. Almost all (> 99%) of those who were infection-naive seroconverted after vaccination.

The primary outcome was anti-spike antibody levels assessed according to dose, previous infection, dosing interval, age, ethnicity, and comorbidities, including immunosuppressive disease such as immune system cancers, rheumatologic disease, chronic respiratory diseases, diabetes, obesity, and chronic neurologic disease. 

In the infection-naive group, the mean antibody (anti-S titer) was 75.48 BAU/mL after the first vaccine dose, and this rose to 7,049.76 BAU/mL after the second dose.

The much higher antibody titer with the second dose in infection-naive individuals “is what gives you the most protection, as your antibody titers are at their peak. They then start to gradually wane from this peak,” said Dr. Otter.

In the post-infection group, antibody titers also rose (2,111.08 BAU/mL after first dose and 16,052.39 BAU/mL after second dose), although less so than in the infection-naive group, because of the additional exposure of infection, added Dr. Otter.

Antibody levels also varied according to time elapsed between natural infection and dose 1 of vaccination. With a 3-month interval, antibody levels were 1,970.83 (1,506.01-2,579.1) BAU/mL, compared with 13,759.31 (8,097.78-23,379.09) BAU/mL after a 9-month interval. Antibody levels after one dose in those previously infected are higher than the infection-naive because “previous infection, then vaccination, is likely explained by T-cell expansion upon a boost with a second antigen exposure, and then a maturing memory B-cell response that has been demonstrated up to 6 months,” explained Dr. Otter.

 

Timing of fourth dose

By March of this year, 86.2% of the U.K. population aged over 12 years had received at least two doses, but with rises in disease prevalence and the spread of variants of concern, further work is ongoing to understand the waning of the immune response, level of protection, and why some individuals develop COVID-19 even when double-vaccinated.

This news organization asked Susanna Dunachie, BMChB, professor of infectious diseases, University of Oxford, U.K., what the interval findings might mean for the timing of the fourth dose of vaccine across the U.K. population.

In the United Kingdom, fourth doses are being given to people who are 75 years and older, residents in care homes for older people, and those with weakened immune systems. “To make decisions about fourth doses for healthy people, we need to see how quickly antibody and T-cell responses drop,” said Ms. Dunachie, who is part of the large SIREN study team but was not involved in the analysis led by Dr. Otter. “Current research suggests that the T-cell response may be better maintained than the antibody response, and less affected by variants like Omicron.”

She explained the balance between antibody and T-cell responses to vaccination. “It is likely that antibodies that neutralize the virus are important for preventing any infection at all, and these unfortunately do fall in time, but T-cell responses are better sustained and help keep people out of [the] hospital,” she said.

Ms. Dunachie added that it was necessary to wait and observe what happens next with SARS-CoV-2 evolution, as well as wait for longer follow-up after the third dose in healthy people. “On current evidence, my estimate is we postpone decisions on fourth doses in healthy people to late summer/autumn.”

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

An overall ninefold increase in COVID-19 antibody levels can be seen with a longer interval between first and second doses of the Pfizer/BioNTech (BNT162b2) vaccine in people without prior infection, according to data from the U.K. government’s SIREN (SARS-CoV-2 Immunity and Reinfection Evaluation) study.

This interval-dependent antibody level varied by age, with those aged 45-54 years showing an 11-fold increase with a longer dosing interval (greater than 10 weeks vs. 2-4 weeks). People younger than age 25 years showed a 13-fold increase with the longer interval, but participant numbers were low in this sub-group.

Overall antibody levels in infection-naive participants were 1,268.72 Binding Antibody Units (BAU)/mL (1,043.25-1,542.91) in those with a 2-4–week interval, compared with 11,479.73 BAU/mL (10,742.78-12,267.24) (P < .0001), in those with at least a 10-week interval between doses.

The work is the latest analysis from SIREN, which measured antibody levels in the blood from nearly 6,000 health care workers from across the United Kingdom. Study lead Ashley Otter, PhD, technical lead for SIREN serology at the UK Health Security Agency (UKHSA), will present the work on Tuesday at the 2022 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), Lisbon.

In an interview, Dr. Otter noted that, “it is important to remember that antibody levels are only one aspect of the immune response, and in our recent vaccine effectiveness analysis, we found that dosing intervals did not affect protection against infection.”

The study, which appeared in the March issue of the New England Journal of Medicine, also found that after the second dose of vaccine, there was about a 2.5–fold difference in antibody levels between those who had prior infection of 16.052 (14.071-18.312) BAU/mL, compared with 7.050 (6.634-7.491) BAU/mL in infection-naive individuals (P < .0001).

Following the first dose only, antibody levels were up to 10 times higher in participants who were previously infected, compared with infection-naive individuals. This effect lasted up to 8 months and then began to plateau.
 

Natural infection increased antibody levels

Dr. Otter remarked that, “COVID-19 antibody levels are high in those people who were previously naturally infected and vaccinated, highlighting that vaccination provides an additional benefit to these individuals.”

This news organization asked Charlotte Thålin, PhD, an immunologist from the Karolinska Institute, Stockholm, to comment on the study. Dr. Thålin studies a cohort similar to SIREN, called the Swedish COMMUNITY health care worker cohort. “The new data from the SIREN emphasizes the importance of the number of antigenic exposures and the time interval between them, whether it be exposure through vaccination or exposure through infection.” 

“We see similar data in our Swedish COMMUNITY health care worker cohort,” Dr. Thålin continued, “where infection prior to vaccination yields a more than twofold enhancement in antibodies, neutralizing breadth, and T cell responses, and an even larger increase with a longer time interval between infection and vaccination.”

However, she cautioned that they now see a high rate of Omicron vaccine breakthrough infections, and this is also true in people with previous infection and three vaccine doses.

“As we approach a second booster – a fourth vaccine dose – we need to consider that many individuals will have had up to five to six antigen exposures within a short period of time, sometimes within a year,” she pointed out. “This is a whole new scenario, with a lot of different combinations of vaccine and infection-induced immunity. We do not yet know the impact of these frequent immune exposures, and we now need to monitor immune responses following Omicron and booster doses closely.”

SIREN originally aimed to understand how much protection people got after developing a primary infection and why they might become reinfected with COVID-19. Following the rollout of the United Kingdom’s vaccination program, the protective effects of vaccination against COVID-19 were investigated, as well as why some people still become ill after being vaccinated, Dr. Otter explained.

In this latest analysis, Dr. Otter and colleagues assessed anti-spike binding antibodies in serum samples from a total of 5,871 health care workers, with 3,989 after one dose (at least 21 days) and 1,882 after two doses (at least 14 days).

Most participants were women (82.3%), of White ethnicity (87%), and came from across the United Kingdom.

Participants were also categorized into those who had evidence of natural COVID-19 infection (confirmed by a PCR test or assumed because of their antibody profile) or those who were infection-naive. Almost all (> 99%) of those who were infection-naive seroconverted after vaccination.

The primary outcome was anti-spike antibody levels assessed according to dose, previous infection, dosing interval, age, ethnicity, and comorbidities, including immunosuppressive disease such as immune system cancers, rheumatologic disease, chronic respiratory diseases, diabetes, obesity, and chronic neurologic disease. 

In the infection-naive group, the mean antibody (anti-S titer) was 75.48 BAU/mL after the first vaccine dose, and this rose to 7,049.76 BAU/mL after the second dose.

The much higher antibody titer with the second dose in infection-naive individuals “is what gives you the most protection, as your antibody titers are at their peak. They then start to gradually wane from this peak,” said Dr. Otter.

In the post-infection group, antibody titers also rose (2,111.08 BAU/mL after first dose and 16,052.39 BAU/mL after second dose), although less so than in the infection-naive group, because of the additional exposure of infection, added Dr. Otter.

Antibody levels also varied according to time elapsed between natural infection and dose 1 of vaccination. With a 3-month interval, antibody levels were 1,970.83 (1,506.01-2,579.1) BAU/mL, compared with 13,759.31 (8,097.78-23,379.09) BAU/mL after a 9-month interval. Antibody levels after one dose in those previously infected are higher than the infection-naive because “previous infection, then vaccination, is likely explained by T-cell expansion upon a boost with a second antigen exposure, and then a maturing memory B-cell response that has been demonstrated up to 6 months,” explained Dr. Otter.

 

Timing of fourth dose

By March of this year, 86.2% of the U.K. population aged over 12 years had received at least two doses, but with rises in disease prevalence and the spread of variants of concern, further work is ongoing to understand the waning of the immune response, level of protection, and why some individuals develop COVID-19 even when double-vaccinated.

This news organization asked Susanna Dunachie, BMChB, professor of infectious diseases, University of Oxford, U.K., what the interval findings might mean for the timing of the fourth dose of vaccine across the U.K. population.

In the United Kingdom, fourth doses are being given to people who are 75 years and older, residents in care homes for older people, and those with weakened immune systems. “To make decisions about fourth doses for healthy people, we need to see how quickly antibody and T-cell responses drop,” said Ms. Dunachie, who is part of the large SIREN study team but was not involved in the analysis led by Dr. Otter. “Current research suggests that the T-cell response may be better maintained than the antibody response, and less affected by variants like Omicron.”

She explained the balance between antibody and T-cell responses to vaccination. “It is likely that antibodies that neutralize the virus are important for preventing any infection at all, and these unfortunately do fall in time, but T-cell responses are better sustained and help keep people out of [the] hospital,” she said.

Ms. Dunachie added that it was necessary to wait and observe what happens next with SARS-CoV-2 evolution, as well as wait for longer follow-up after the third dose in healthy people. “On current evidence, my estimate is we postpone decisions on fourth doses in healthy people to late summer/autumn.”

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

An overall ninefold increase in COVID-19 antibody levels can be seen with a longer interval between first and second doses of the Pfizer/BioNTech (BNT162b2) vaccine in people without prior infection, according to data from the U.K. government’s SIREN (SARS-CoV-2 Immunity and Reinfection Evaluation) study.

This interval-dependent antibody level varied by age, with those aged 45-54 years showing an 11-fold increase with a longer dosing interval (greater than 10 weeks vs. 2-4 weeks). People younger than age 25 years showed a 13-fold increase with the longer interval, but participant numbers were low in this sub-group.

Overall antibody levels in infection-naive participants were 1,268.72 Binding Antibody Units (BAU)/mL (1,043.25-1,542.91) in those with a 2-4–week interval, compared with 11,479.73 BAU/mL (10,742.78-12,267.24) (P < .0001), in those with at least a 10-week interval between doses.

The work is the latest analysis from SIREN, which measured antibody levels in the blood from nearly 6,000 health care workers from across the United Kingdom. Study lead Ashley Otter, PhD, technical lead for SIREN serology at the UK Health Security Agency (UKHSA), will present the work on Tuesday at the 2022 European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), Lisbon.

In an interview, Dr. Otter noted that, “it is important to remember that antibody levels are only one aspect of the immune response, and in our recent vaccine effectiveness analysis, we found that dosing intervals did not affect protection against infection.”

The study, which appeared in the March issue of the New England Journal of Medicine, also found that after the second dose of vaccine, there was about a 2.5–fold difference in antibody levels between those who had prior infection of 16.052 (14.071-18.312) BAU/mL, compared with 7.050 (6.634-7.491) BAU/mL in infection-naive individuals (P < .0001).

Following the first dose only, antibody levels were up to 10 times higher in participants who were previously infected, compared with infection-naive individuals. This effect lasted up to 8 months and then began to plateau.
 

Natural infection increased antibody levels

Dr. Otter remarked that, “COVID-19 antibody levels are high in those people who were previously naturally infected and vaccinated, highlighting that vaccination provides an additional benefit to these individuals.”

This news organization asked Charlotte Thålin, PhD, an immunologist from the Karolinska Institute, Stockholm, to comment on the study. Dr. Thålin studies a cohort similar to SIREN, called the Swedish COMMUNITY health care worker cohort. “The new data from the SIREN emphasizes the importance of the number of antigenic exposures and the time interval between them, whether it be exposure through vaccination or exposure through infection.” 

“We see similar data in our Swedish COMMUNITY health care worker cohort,” Dr. Thålin continued, “where infection prior to vaccination yields a more than twofold enhancement in antibodies, neutralizing breadth, and T cell responses, and an even larger increase with a longer time interval between infection and vaccination.”

However, she cautioned that they now see a high rate of Omicron vaccine breakthrough infections, and this is also true in people with previous infection and three vaccine doses.

“As we approach a second booster – a fourth vaccine dose – we need to consider that many individuals will have had up to five to six antigen exposures within a short period of time, sometimes within a year,” she pointed out. “This is a whole new scenario, with a lot of different combinations of vaccine and infection-induced immunity. We do not yet know the impact of these frequent immune exposures, and we now need to monitor immune responses following Omicron and booster doses closely.”

SIREN originally aimed to understand how much protection people got after developing a primary infection and why they might become reinfected with COVID-19. Following the rollout of the United Kingdom’s vaccination program, the protective effects of vaccination against COVID-19 were investigated, as well as why some people still become ill after being vaccinated, Dr. Otter explained.

In this latest analysis, Dr. Otter and colleagues assessed anti-spike binding antibodies in serum samples from a total of 5,871 health care workers, with 3,989 after one dose (at least 21 days) and 1,882 after two doses (at least 14 days).

Most participants were women (82.3%), of White ethnicity (87%), and came from across the United Kingdom.

Participants were also categorized into those who had evidence of natural COVID-19 infection (confirmed by a PCR test or assumed because of their antibody profile) or those who were infection-naive. Almost all (> 99%) of those who were infection-naive seroconverted after vaccination.

The primary outcome was anti-spike antibody levels assessed according to dose, previous infection, dosing interval, age, ethnicity, and comorbidities, including immunosuppressive disease such as immune system cancers, rheumatologic disease, chronic respiratory diseases, diabetes, obesity, and chronic neurologic disease. 

In the infection-naive group, the mean antibody (anti-S titer) was 75.48 BAU/mL after the first vaccine dose, and this rose to 7,049.76 BAU/mL after the second dose.

The much higher antibody titer with the second dose in infection-naive individuals “is what gives you the most protection, as your antibody titers are at their peak. They then start to gradually wane from this peak,” said Dr. Otter.

In the post-infection group, antibody titers also rose (2,111.08 BAU/mL after first dose and 16,052.39 BAU/mL after second dose), although less so than in the infection-naive group, because of the additional exposure of infection, added Dr. Otter.

Antibody levels also varied according to time elapsed between natural infection and dose 1 of vaccination. With a 3-month interval, antibody levels were 1,970.83 (1,506.01-2,579.1) BAU/mL, compared with 13,759.31 (8,097.78-23,379.09) BAU/mL after a 9-month interval. Antibody levels after one dose in those previously infected are higher than the infection-naive because “previous infection, then vaccination, is likely explained by T-cell expansion upon a boost with a second antigen exposure, and then a maturing memory B-cell response that has been demonstrated up to 6 months,” explained Dr. Otter.

 

Timing of fourth dose

By March of this year, 86.2% of the U.K. population aged over 12 years had received at least two doses, but with rises in disease prevalence and the spread of variants of concern, further work is ongoing to understand the waning of the immune response, level of protection, and why some individuals develop COVID-19 even when double-vaccinated.

This news organization asked Susanna Dunachie, BMChB, professor of infectious diseases, University of Oxford, U.K., what the interval findings might mean for the timing of the fourth dose of vaccine across the U.K. population.

In the United Kingdom, fourth doses are being given to people who are 75 years and older, residents in care homes for older people, and those with weakened immune systems. “To make decisions about fourth doses for healthy people, we need to see how quickly antibody and T-cell responses drop,” said Ms. Dunachie, who is part of the large SIREN study team but was not involved in the analysis led by Dr. Otter. “Current research suggests that the T-cell response may be better maintained than the antibody response, and less affected by variants like Omicron.”

She explained the balance between antibody and T-cell responses to vaccination. “It is likely that antibodies that neutralize the virus are important for preventing any infection at all, and these unfortunately do fall in time, but T-cell responses are better sustained and help keep people out of [the] hospital,” she said.

Ms. Dunachie added that it was necessary to wait and observe what happens next with SARS-CoV-2 evolution, as well as wait for longer follow-up after the third dose in healthy people. “On current evidence, my estimate is we postpone decisions on fourth doses in healthy people to late summer/autumn.”

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