MDedge Pediatrics

Higher concentrations of specific volatile organic compounds (VOCs) in daycare centers were significantly associated with an increased risk for wheezing in children who attended these centers, based on data from more than 500 children.

“There is an increasing concern about of the role of Indoor Air Quality (IAQ) in development of respiratory disorders like asthma, especially in children whose immune system is under development, and they are more vulnerable to the effects of poor air quality,” lead author Ioannis Sakellaris, PhD, of Université Paris-Saclay, Villejuif, France, said in an interview. However, the effects of specific pollutants on the health of young children in daycare settings has not been examined, he said. 

In a presentation at the European Respiratory Society Congress, Sakellaris reviewed data from the French CRESPI cohort study, an epidemiological study of the impact of exposures to disinfectants and cleaning products on workers and children in daycare centers in France.

The study population included 532 children (47.4% girls) with a mean age of 22.3 months (aged 3 months to 4 years) in 106 daycare centers. A total of 171 children reportedly experienced at least one episode of wheezing since birth. 

A total of 67 VOCs were measured during one day, and concentrations were studied in four categories based on quartiles. The researchers evaluated three child wheezing outcomes based on parental questionnaires: Ever wheeze since birth, recurrent wheeze (≥ 3 times since birth), and ever wheeze with inhaled corticosteroid use. The researchers adjusted for factors including child age and parental smoking status and education level.

Overall, ever wheezing was significantly associated with higher concentrations of 1,2,4-trimethylbenzene (odds ratio [OR] for Q4 vs Q1, 1.56; P = .08 for trend), 1-methoxy-2-propylacetate (OR, 1.62; P = .01), decamethylcyclopentasiloxane (OR, 2.12; P = .004), and methylisobutylcetone (OR, 1.85; P < .001).

The results emphasize the significant role of IAQ in respiratory health, said Sakellaris. “Further efforts to reduce pollutant concentrations and limit sources are needed,” he said. In addition, more studies on the combined effect of multiple VOCs are necessary for a deeper understanding of the complex relations between IAQ and children’s respiratory health, he said.
 

Pay Attention to Indoor Pollutants

“Since the COVID-19 pandemic, the use of cleaning products and disinfectants has exploded,” Alexander S. Rabin, MD, of the University of Michigan, Ann Arbor, Michigan, said in an interview. Although many of these cleaning agents contain chemicals, including VOCs, that are known respiratory irritants, little is known about the relationship between VOCs and children’s respiratory outcomes in daycare settings, said Rabin, who was not involved in the study.

“I was struck by the wide array of VOCs detected in daycare settings,” Rabin said. However, the relationship to childhood wheeze was not entirely surprising as the VOCs included the known irritants benzene and toluene, he added.

The results suggest that exposure to VOCs, not only in cleaning agents but also building materials and other consumer products in daycare settings, may be associated with an increased risk for wheeze in children, said Rabin. 

However, “it is important to know more about confounding variables, including concurrent rates of respiratory infection that are common among children,” said Rabin. “As the authors highlight, further work on the compound effects of multiple pollutants would be of interest. Lastly, it would be helpful to clearly identify the most common sources of VOCs that place children at greatest risk for wheeze, so that appropriate steps can be taken to mitigate risk,” he said.

The original CRESPI cohort study was supported by ANSES, ADEME, Fondation de France, and ARS Ile-de-France. Sakellaris and Rabin had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

Higher concentrations of specific volatile organic compounds (VOCs) in daycare centers were significantly associated with an increased risk for wheezing in children who attended these centers, based on data from more than 500 children.

“There is an increasing concern about of the role of Indoor Air Quality (IAQ) in development of respiratory disorders like asthma, especially in children whose immune system is under development, and they are more vulnerable to the effects of poor air quality,” lead author Ioannis Sakellaris, PhD, of Université Paris-Saclay, Villejuif, France, said in an interview. However, the effects of specific pollutants on the health of young children in daycare settings has not been examined, he said. 

In a presentation at the European Respiratory Society Congress, Sakellaris reviewed data from the French CRESPI cohort study, an epidemiological study of the impact of exposures to disinfectants and cleaning products on workers and children in daycare centers in France.

The study population included 532 children (47.4% girls) with a mean age of 22.3 months (aged 3 months to 4 years) in 106 daycare centers. A total of 171 children reportedly experienced at least one episode of wheezing since birth. 

A total of 67 VOCs were measured during one day, and concentrations were studied in four categories based on quartiles. The researchers evaluated three child wheezing outcomes based on parental questionnaires: Ever wheeze since birth, recurrent wheeze (≥ 3 times since birth), and ever wheeze with inhaled corticosteroid use. The researchers adjusted for factors including child age and parental smoking status and education level.

Overall, ever wheezing was significantly associated with higher concentrations of 1,2,4-trimethylbenzene (odds ratio [OR] for Q4 vs Q1, 1.56; P = .08 for trend), 1-methoxy-2-propylacetate (OR, 1.62; P = .01), decamethylcyclopentasiloxane (OR, 2.12; P = .004), and methylisobutylcetone (OR, 1.85; P < .001).

The results emphasize the significant role of IAQ in respiratory health, said Sakellaris. “Further efforts to reduce pollutant concentrations and limit sources are needed,” he said. In addition, more studies on the combined effect of multiple VOCs are necessary for a deeper understanding of the complex relations between IAQ and children’s respiratory health, he said.
 

Pay Attention to Indoor Pollutants

“Since the COVID-19 pandemic, the use of cleaning products and disinfectants has exploded,” Alexander S. Rabin, MD, of the University of Michigan, Ann Arbor, Michigan, said in an interview. Although many of these cleaning agents contain chemicals, including VOCs, that are known respiratory irritants, little is known about the relationship between VOCs and children’s respiratory outcomes in daycare settings, said Rabin, who was not involved in the study.

“I was struck by the wide array of VOCs detected in daycare settings,” Rabin said. However, the relationship to childhood wheeze was not entirely surprising as the VOCs included the known irritants benzene and toluene, he added.

The results suggest that exposure to VOCs, not only in cleaning agents but also building materials and other consumer products in daycare settings, may be associated with an increased risk for wheeze in children, said Rabin. 

However, “it is important to know more about confounding variables, including concurrent rates of respiratory infection that are common among children,” said Rabin. “As the authors highlight, further work on the compound effects of multiple pollutants would be of interest. Lastly, it would be helpful to clearly identify the most common sources of VOCs that place children at greatest risk for wheeze, so that appropriate steps can be taken to mitigate risk,” he said.

The original CRESPI cohort study was supported by ANSES, ADEME, Fondation de France, and ARS Ile-de-France. Sakellaris and Rabin had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

Higher concentrations of specific volatile organic compounds (VOCs) in daycare centers were significantly associated with an increased risk for wheezing in children who attended these centers, based on data from more than 500 children.

“There is an increasing concern about of the role of Indoor Air Quality (IAQ) in development of respiratory disorders like asthma, especially in children whose immune system is under development, and they are more vulnerable to the effects of poor air quality,” lead author Ioannis Sakellaris, PhD, of Université Paris-Saclay, Villejuif, France, said in an interview. However, the effects of specific pollutants on the health of young children in daycare settings has not been examined, he said. 

In a presentation at the European Respiratory Society Congress, Sakellaris reviewed data from the French CRESPI cohort study, an epidemiological study of the impact of exposures to disinfectants and cleaning products on workers and children in daycare centers in France.

The study population included 532 children (47.4% girls) with a mean age of 22.3 months (aged 3 months to 4 years) in 106 daycare centers. A total of 171 children reportedly experienced at least one episode of wheezing since birth. 

A total of 67 VOCs were measured during one day, and concentrations were studied in four categories based on quartiles. The researchers evaluated three child wheezing outcomes based on parental questionnaires: Ever wheeze since birth, recurrent wheeze (≥ 3 times since birth), and ever wheeze with inhaled corticosteroid use. The researchers adjusted for factors including child age and parental smoking status and education level.

Overall, ever wheezing was significantly associated with higher concentrations of 1,2,4-trimethylbenzene (odds ratio [OR] for Q4 vs Q1, 1.56; P = .08 for trend), 1-methoxy-2-propylacetate (OR, 1.62; P = .01), decamethylcyclopentasiloxane (OR, 2.12; P = .004), and methylisobutylcetone (OR, 1.85; P < .001).

The results emphasize the significant role of IAQ in respiratory health, said Sakellaris. “Further efforts to reduce pollutant concentrations and limit sources are needed,” he said. In addition, more studies on the combined effect of multiple VOCs are necessary for a deeper understanding of the complex relations between IAQ and children’s respiratory health, he said.
 

Pay Attention to Indoor Pollutants

“Since the COVID-19 pandemic, the use of cleaning products and disinfectants has exploded,” Alexander S. Rabin, MD, of the University of Michigan, Ann Arbor, Michigan, said in an interview. Although many of these cleaning agents contain chemicals, including VOCs, that are known respiratory irritants, little is known about the relationship between VOCs and children’s respiratory outcomes in daycare settings, said Rabin, who was not involved in the study.

“I was struck by the wide array of VOCs detected in daycare settings,” Rabin said. However, the relationship to childhood wheeze was not entirely surprising as the VOCs included the known irritants benzene and toluene, he added.

The results suggest that exposure to VOCs, not only in cleaning agents but also building materials and other consumer products in daycare settings, may be associated with an increased risk for wheeze in children, said Rabin. 

However, “it is important to know more about confounding variables, including concurrent rates of respiratory infection that are common among children,” said Rabin. “As the authors highlight, further work on the compound effects of multiple pollutants would be of interest. Lastly, it would be helpful to clearly identify the most common sources of VOCs that place children at greatest risk for wheeze, so that appropriate steps can be taken to mitigate risk,” he said.

The original CRESPI cohort study was supported by ANSES, ADEME, Fondation de France, and ARS Ile-de-France. Sakellaris and Rabin had no financial conflicts to disclose.
 

A version of this article appeared on Medscape.com.

ORLANDO — More than half of youth improved after receiving a dose of naloxone by emergency medical services (EMS) after an emergency dispatch call, according to research presented at the American Academy of Pediatrics 2024 National Conference.

“Emergency responders or EMS are often the first to arrive to an opioid poisoning, and they’re often the first to give naloxone, a potentially lifesaving medication,” said Christopher E. Gaw, MD, MPH, MBE, assistant professor of pediatrics at The Ohio State University College of Medicine and an emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

Ohio State University

“Our study highlights and underscores its safety of use in the prehospital setting, and this is also supported by other data,” Gaw said. “Efforts to support public distribution and education on naloxone can really help each and every one of us as individual citizens prevent pediatric harm from the opioid crisis.”

Additional research at the meeting showed that teens’ knowledge, attitudes, and confidence about recognizing overdoses and assisting with naloxone administration improved following a peer-to-peer training program, suggesting that teens can play an important role in reducing youth mortality from overdoses.

An average of 22 American teens died from overdose every week in 2022, and as counterfeit pill use has increased among youth, research has found that fentanyl was detected in 93% of overdose deaths with counterfeit pills, according to Talia Puzantian, PharmD, BCPP, of the Keck Graduate Institute School of Pharmacy, Claremont, California, who led the study on peer education. Yet a recent survey had found that less than a third of teens (30%) knew what naloxone was, and only 14% knew how to administer it.

“Ensuring that adolescents have easy and confidential access to naloxone is important and can save lives,” said Taylor Nichols, MD, assistant clinical professor at the University of California San Francisco and an emergency medicine and addiction medicine–certified physician. “I have had teen patients who have told me that they have had to use naloxone obtained from our clinic on friends when they have accidentally overdosed.”

University of California

EMS Naloxone Administration to Youth

EMS clinicians are often the first healthcare providers to respond to an opioid overdose or poisoning event, and evidence-based guidelines for EMS naloxone administration were developed in 2019 to support this intervention. Gaw’s team investigated the frequency and demographics of pediatric administration of naloxone.

They analyzed data from the National Emergency Medical Services Information System on EMS activations for administration of at least one dose of naloxone during 2022 to those aged 0-17. There were 6215 EMS pediatric administrations of naloxone that year, and in the vast majority of cases (82%), the patient had not received a naloxone injection prior to EMS’s arrival.

Most patients (79%) were aged 13-17 years, but 10% were in the 6-12 age group. The remaining patients included 6% infants younger than 1 year and 4% aged 6-12 years. Just over half were for males (55%), and most were dispatched to a home or residential setting (61%). One in five incidents (22%) occurred at a non-healthcare business, 9% on a street or highway, and the rest at a healthcare facility or another location.

Most of the incidents occurred in urban areas (86%), followed by rural (7%), suburban (6%), and wilderness (1.4%). More occurred in the US South (42%) than in the West (29%), Midwest (22%), or Northeast (7.5%).

A key takeaway of those demographic findings is that ingestions and accidental poisonings with opioids can occur in children of any age, Nichols said. “Every single home that has any opioids in the home should absolutely have naloxone immediately available as well,” he said. “Every single person who is prescribed opioids should also have naloxone available and accessible and to be sure that the naloxone is not expired or otherwise tampered with and update that every few years.” He noted that Narcan expiration was recently extended from 3 years to 4 years by the US Food and Drug Administration (FDA).

“I always advise that people who have opioid medications keep them stored safely and securely,” Nichols said. “However, I also acknowledge that even perfect systems fail and that people make mistakes and may accidentally leave medication out, within reach, or otherwise unsecured. If that happens, and someone were to intentionally or unintentionally get into that medication and potentially overdose as a result, we want to have that reversal medication immediately available to reverse the overdose.”

In nearly all cases (91%), EMS provided advanced life support, with only 7.5% patients receiving basic life support and 1.5% receiving specialty critical care. Just under a third (29%) of the dispatch calls were for “overdose/poisoning/ingestion.” Other dispatch calls included “unconscious/fainting/near-fainting” (21%) or “cardiac arrest/death” (17%), but the frequency of each dispatch label varied by age groups.

For example, 38% of calls for infants were for cardiac arrest, compared with 15% of calls for older teens and 18% of calls for 6-12 year olds. An overdose/poisoning dispatch was meanwhile more common for teens (32%) than for infants (13%), younger children (23%), and older children/tweens (18%). Other dispatch complaints included “sick person/person down/unknown problem” (12%) and “breathing problem” (5%).

A possible reason for these variations is that “an overdose might be mistaken for another medical emergency, or vice versa, because opioid poisonings can be challenging to recognize, especially in young children and in the pediatric population,” Gaw said. “Both the public and emergency responders should maintain a high level of suspicion” of possible overdose for children with the signs or symptoms of it, such as low breathing, unresponsiveness, or small pupils.

In most cases (87%), the patient was not in cardiac arrest, though the patient had entered cardiac arrest before EMS’s arrival in 11.5% of cases. Two thirds of cases only involved one dose of naloxone, while the other 33% involved two doses.

Ryan Marino, MD, an addiction medicine specialist and an associate professor of emergency medicine at Case Western Reserve University School of Medicine in Cleveland, Ohio, who was not involved in the study, took note of the high proportion of cases in which two doses were administered.

“While there is, in my professional opinion, almost no downside to giving naloxone in situations like this, and everybody should have it available and know how to use it, I would caution people on the risk of anchor bias, especially when more than two doses of naloxone are given, since we know that one should be an effective amount for any known opioid overdose,” Marino said. Anchoring bias refers to the tendency for individuals to rely more heavily on the first piece of information they receive about a topic or situation.

“For first responders and healthcare professionals, the importance of additional resuscitation measures like oxygenation and ventilation are just as crucial,” Marino said. “People should not be discouraged if someone doesn’t immediately respond to naloxone as overdose physiology can cause mental status to stay impaired for other reasons beyond direct drug effect, such as hypercarbia, but continue to seek and/or provide additional emergency care in these situations.”

Patients improved after one dose in just over half the cases (54%), and their conditions were unchanged in 46% of cases. There were only 11 cases in which the patient’s condition worsened after a naloxone dose (0.2%). Most of the cases (88%) were transported by EMS, and there were 13 total deaths at the scene (0.2%).

Nichols found the low incidence of worsening clinical status particularly striking. “This is further evidence of a critically important point — naloxone is purely an opioid antagonist, and only binds to opioid receptors, such that if a person has not overdosed on opioids or does not otherwise have opioids in their system, naloxone will not have a significant effect and will not cause them harm,” Nichols said.

“The most common causes of harm are due to rapid reversal of overdose and the potential risks involved in the rapid reversal of opioid effects and potentially precipitating withdrawal, and as this paper demonstrates, these are exceedingly rare,” he said. “Given that, we should have an incredibly low barrier to administer naloxone appropriately.”

The study was limited by inability to know how many true pediatric opioid poisonings are managed by EMS, so future research could look at linking EMS and emergency room hospital databases.
 

Improved Self-Efficacy in Teens

Another study showed that a peer-to-peer training program increased teens’ knowledge about overdoses from 34% before training to 79% after (P < .0001), and it substantially improved their confidence in recognizing an overdose and administering naloxone.

Nichols said the study shows the importance of ensuring “that adolescents know how to keep themselves and their friends safe in the case that they or anyone they know does end up using illicit substances which either intentionally or unintentionally contain opioids.”

This study assessed a training program with 206 students in a Los Angeles County high school who were trained by their peers between November 2023 and March 2024. The training included trends in teen overdose deaths, defining what opioids and fentanyl are, recognizing an overdose, and responding to one with naloxone.

The teens were an average 16 years old, about evenly split between boys and girls, and mostly in 11th (40%) or 12th (28%) grade, though nearly a third (29%) were 9th graders.

The students’ knowledge about fentanyl’s presence in counterfeit pills increased from 21% before the training to 68% afterward, and their correct identification of an overdose increased from 47% of participants to 90%.

The students’ confidence and attitudes toward helping with an overdose also improved substantially after the training. About two thirds agreed that non-medical people should be able to carry naloxone before the training, and that rose to 88% agreeing after the training. The proportion who agreed they would be willing to assist in an overdose rose from 77% before to 89% after training.

More dramatically, the teens’ confidence after training more than doubled in recognizing an overdose (from 31% to 81%) and more than tripled in their ability to give naloxone during an overdose (from 26% to 83%).

“The critical piece to keep in mind is that the concern about opioid overdose is respiratory depression leading to a lack of oxygen getting to the brain,” Nichols explained. “In the event of an overdose, time is brain — the longer the brain is deprived of oxygen, the lower the chance of survival. There is no specific time at which naloxone would become less effective at reversing an overdose.”

Therefore, people do not need to know the exact time that someone may have overdosed or how long they have been passed out in order to administer naloxone, he said. “The sooner naloxone is administered to someone who is unresponsive and who may have overdosed on opioids, the higher the likelihood of a successful reversal of an overdose and of saving a life.”

The peer-to-peer program was sponsored by the CARLOW Center for Medical Innovation, and the EMS study used no external funding. The authors of both studies and Marino had no disclosures. Nichols has consulted or clinically advised TV shows and health tech startup companies and has no disclosures related to naloxone or the pharmaceutical industry.
 

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

ORLANDO — More than half of youth improved after receiving a dose of naloxone by emergency medical services (EMS) after an emergency dispatch call, according to research presented at the American Academy of Pediatrics 2024 National Conference.

“Emergency responders or EMS are often the first to arrive to an opioid poisoning, and they’re often the first to give naloxone, a potentially lifesaving medication,” said Christopher E. Gaw, MD, MPH, MBE, assistant professor of pediatrics at The Ohio State University College of Medicine and an emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

Ohio State University

“Our study highlights and underscores its safety of use in the prehospital setting, and this is also supported by other data,” Gaw said. “Efforts to support public distribution and education on naloxone can really help each and every one of us as individual citizens prevent pediatric harm from the opioid crisis.”

Additional research at the meeting showed that teens’ knowledge, attitudes, and confidence about recognizing overdoses and assisting with naloxone administration improved following a peer-to-peer training program, suggesting that teens can play an important role in reducing youth mortality from overdoses.

An average of 22 American teens died from overdose every week in 2022, and as counterfeit pill use has increased among youth, research has found that fentanyl was detected in 93% of overdose deaths with counterfeit pills, according to Talia Puzantian, PharmD, BCPP, of the Keck Graduate Institute School of Pharmacy, Claremont, California, who led the study on peer education. Yet a recent survey had found that less than a third of teens (30%) knew what naloxone was, and only 14% knew how to administer it.

“Ensuring that adolescents have easy and confidential access to naloxone is important and can save lives,” said Taylor Nichols, MD, assistant clinical professor at the University of California San Francisco and an emergency medicine and addiction medicine–certified physician. “I have had teen patients who have told me that they have had to use naloxone obtained from our clinic on friends when they have accidentally overdosed.”

University of California

EMS Naloxone Administration to Youth

EMS clinicians are often the first healthcare providers to respond to an opioid overdose or poisoning event, and evidence-based guidelines for EMS naloxone administration were developed in 2019 to support this intervention. Gaw’s team investigated the frequency and demographics of pediatric administration of naloxone.

They analyzed data from the National Emergency Medical Services Information System on EMS activations for administration of at least one dose of naloxone during 2022 to those aged 0-17. There were 6215 EMS pediatric administrations of naloxone that year, and in the vast majority of cases (82%), the patient had not received a naloxone injection prior to EMS’s arrival.

Most patients (79%) were aged 13-17 years, but 10% were in the 6-12 age group. The remaining patients included 6% infants younger than 1 year and 4% aged 6-12 years. Just over half were for males (55%), and most were dispatched to a home or residential setting (61%). One in five incidents (22%) occurred at a non-healthcare business, 9% on a street or highway, and the rest at a healthcare facility or another location.

Most of the incidents occurred in urban areas (86%), followed by rural (7%), suburban (6%), and wilderness (1.4%). More occurred in the US South (42%) than in the West (29%), Midwest (22%), or Northeast (7.5%).

A key takeaway of those demographic findings is that ingestions and accidental poisonings with opioids can occur in children of any age, Nichols said. “Every single home that has any opioids in the home should absolutely have naloxone immediately available as well,” he said. “Every single person who is prescribed opioids should also have naloxone available and accessible and to be sure that the naloxone is not expired or otherwise tampered with and update that every few years.” He noted that Narcan expiration was recently extended from 3 years to 4 years by the US Food and Drug Administration (FDA).

“I always advise that people who have opioid medications keep them stored safely and securely,” Nichols said. “However, I also acknowledge that even perfect systems fail and that people make mistakes and may accidentally leave medication out, within reach, or otherwise unsecured. If that happens, and someone were to intentionally or unintentionally get into that medication and potentially overdose as a result, we want to have that reversal medication immediately available to reverse the overdose.”

In nearly all cases (91%), EMS provided advanced life support, with only 7.5% patients receiving basic life support and 1.5% receiving specialty critical care. Just under a third (29%) of the dispatch calls were for “overdose/poisoning/ingestion.” Other dispatch calls included “unconscious/fainting/near-fainting” (21%) or “cardiac arrest/death” (17%), but the frequency of each dispatch label varied by age groups.

For example, 38% of calls for infants were for cardiac arrest, compared with 15% of calls for older teens and 18% of calls for 6-12 year olds. An overdose/poisoning dispatch was meanwhile more common for teens (32%) than for infants (13%), younger children (23%), and older children/tweens (18%). Other dispatch complaints included “sick person/person down/unknown problem” (12%) and “breathing problem” (5%).

A possible reason for these variations is that “an overdose might be mistaken for another medical emergency, or vice versa, because opioid poisonings can be challenging to recognize, especially in young children and in the pediatric population,” Gaw said. “Both the public and emergency responders should maintain a high level of suspicion” of possible overdose for children with the signs or symptoms of it, such as low breathing, unresponsiveness, or small pupils.

In most cases (87%), the patient was not in cardiac arrest, though the patient had entered cardiac arrest before EMS’s arrival in 11.5% of cases. Two thirds of cases only involved one dose of naloxone, while the other 33% involved two doses.

Ryan Marino, MD, an addiction medicine specialist and an associate professor of emergency medicine at Case Western Reserve University School of Medicine in Cleveland, Ohio, who was not involved in the study, took note of the high proportion of cases in which two doses were administered.

“While there is, in my professional opinion, almost no downside to giving naloxone in situations like this, and everybody should have it available and know how to use it, I would caution people on the risk of anchor bias, especially when more than two doses of naloxone are given, since we know that one should be an effective amount for any known opioid overdose,” Marino said. Anchoring bias refers to the tendency for individuals to rely more heavily on the first piece of information they receive about a topic or situation.

“For first responders and healthcare professionals, the importance of additional resuscitation measures like oxygenation and ventilation are just as crucial,” Marino said. “People should not be discouraged if someone doesn’t immediately respond to naloxone as overdose physiology can cause mental status to stay impaired for other reasons beyond direct drug effect, such as hypercarbia, but continue to seek and/or provide additional emergency care in these situations.”

Patients improved after one dose in just over half the cases (54%), and their conditions were unchanged in 46% of cases. There were only 11 cases in which the patient’s condition worsened after a naloxone dose (0.2%). Most of the cases (88%) were transported by EMS, and there were 13 total deaths at the scene (0.2%).

Nichols found the low incidence of worsening clinical status particularly striking. “This is further evidence of a critically important point — naloxone is purely an opioid antagonist, and only binds to opioid receptors, such that if a person has not overdosed on opioids or does not otherwise have opioids in their system, naloxone will not have a significant effect and will not cause them harm,” Nichols said.

“The most common causes of harm are due to rapid reversal of overdose and the potential risks involved in the rapid reversal of opioid effects and potentially precipitating withdrawal, and as this paper demonstrates, these are exceedingly rare,” he said. “Given that, we should have an incredibly low barrier to administer naloxone appropriately.”

The study was limited by inability to know how many true pediatric opioid poisonings are managed by EMS, so future research could look at linking EMS and emergency room hospital databases.
 

Improved Self-Efficacy in Teens

Another study showed that a peer-to-peer training program increased teens’ knowledge about overdoses from 34% before training to 79% after (P < .0001), and it substantially improved their confidence in recognizing an overdose and administering naloxone.

Nichols said the study shows the importance of ensuring “that adolescents know how to keep themselves and their friends safe in the case that they or anyone they know does end up using illicit substances which either intentionally or unintentionally contain opioids.”

This study assessed a training program with 206 students in a Los Angeles County high school who were trained by their peers between November 2023 and March 2024. The training included trends in teen overdose deaths, defining what opioids and fentanyl are, recognizing an overdose, and responding to one with naloxone.

The teens were an average 16 years old, about evenly split between boys and girls, and mostly in 11th (40%) or 12th (28%) grade, though nearly a third (29%) were 9th graders.

The students’ knowledge about fentanyl’s presence in counterfeit pills increased from 21% before the training to 68% afterward, and their correct identification of an overdose increased from 47% of participants to 90%.

The students’ confidence and attitudes toward helping with an overdose also improved substantially after the training. About two thirds agreed that non-medical people should be able to carry naloxone before the training, and that rose to 88% agreeing after the training. The proportion who agreed they would be willing to assist in an overdose rose from 77% before to 89% after training.

More dramatically, the teens’ confidence after training more than doubled in recognizing an overdose (from 31% to 81%) and more than tripled in their ability to give naloxone during an overdose (from 26% to 83%).

“The critical piece to keep in mind is that the concern about opioid overdose is respiratory depression leading to a lack of oxygen getting to the brain,” Nichols explained. “In the event of an overdose, time is brain — the longer the brain is deprived of oxygen, the lower the chance of survival. There is no specific time at which naloxone would become less effective at reversing an overdose.”

Therefore, people do not need to know the exact time that someone may have overdosed or how long they have been passed out in order to administer naloxone, he said. “The sooner naloxone is administered to someone who is unresponsive and who may have overdosed on opioids, the higher the likelihood of a successful reversal of an overdose and of saving a life.”

The peer-to-peer program was sponsored by the CARLOW Center for Medical Innovation, and the EMS study used no external funding. The authors of both studies and Marino had no disclosures. Nichols has consulted or clinically advised TV shows and health tech startup companies and has no disclosures related to naloxone or the pharmaceutical industry.
 

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

ORLANDO — More than half of youth improved after receiving a dose of naloxone by emergency medical services (EMS) after an emergency dispatch call, according to research presented at the American Academy of Pediatrics 2024 National Conference.

“Emergency responders or EMS are often the first to arrive to an opioid poisoning, and they’re often the first to give naloxone, a potentially lifesaving medication,” said Christopher E. Gaw, MD, MPH, MBE, assistant professor of pediatrics at The Ohio State University College of Medicine and an emergency medicine physician at Nationwide Children’s Hospital in Columbus, Ohio.

Ohio State University

“Our study highlights and underscores its safety of use in the prehospital setting, and this is also supported by other data,” Gaw said. “Efforts to support public distribution and education on naloxone can really help each and every one of us as individual citizens prevent pediatric harm from the opioid crisis.”

Additional research at the meeting showed that teens’ knowledge, attitudes, and confidence about recognizing overdoses and assisting with naloxone administration improved following a peer-to-peer training program, suggesting that teens can play an important role in reducing youth mortality from overdoses.

An average of 22 American teens died from overdose every week in 2022, and as counterfeit pill use has increased among youth, research has found that fentanyl was detected in 93% of overdose deaths with counterfeit pills, according to Talia Puzantian, PharmD, BCPP, of the Keck Graduate Institute School of Pharmacy, Claremont, California, who led the study on peer education. Yet a recent survey had found that less than a third of teens (30%) knew what naloxone was, and only 14% knew how to administer it.

“Ensuring that adolescents have easy and confidential access to naloxone is important and can save lives,” said Taylor Nichols, MD, assistant clinical professor at the University of California San Francisco and an emergency medicine and addiction medicine–certified physician. “I have had teen patients who have told me that they have had to use naloxone obtained from our clinic on friends when they have accidentally overdosed.”

University of California

EMS Naloxone Administration to Youth

EMS clinicians are often the first healthcare providers to respond to an opioid overdose or poisoning event, and evidence-based guidelines for EMS naloxone administration were developed in 2019 to support this intervention. Gaw’s team investigated the frequency and demographics of pediatric administration of naloxone.

They analyzed data from the National Emergency Medical Services Information System on EMS activations for administration of at least one dose of naloxone during 2022 to those aged 0-17. There were 6215 EMS pediatric administrations of naloxone that year, and in the vast majority of cases (82%), the patient had not received a naloxone injection prior to EMS’s arrival.

Most patients (79%) were aged 13-17 years, but 10% were in the 6-12 age group. The remaining patients included 6% infants younger than 1 year and 4% aged 6-12 years. Just over half were for males (55%), and most were dispatched to a home or residential setting (61%). One in five incidents (22%) occurred at a non-healthcare business, 9% on a street or highway, and the rest at a healthcare facility or another location.

Most of the incidents occurred in urban areas (86%), followed by rural (7%), suburban (6%), and wilderness (1.4%). More occurred in the US South (42%) than in the West (29%), Midwest (22%), or Northeast (7.5%).

A key takeaway of those demographic findings is that ingestions and accidental poisonings with opioids can occur in children of any age, Nichols said. “Every single home that has any opioids in the home should absolutely have naloxone immediately available as well,” he said. “Every single person who is prescribed opioids should also have naloxone available and accessible and to be sure that the naloxone is not expired or otherwise tampered with and update that every few years.” He noted that Narcan expiration was recently extended from 3 years to 4 years by the US Food and Drug Administration (FDA).

“I always advise that people who have opioid medications keep them stored safely and securely,” Nichols said. “However, I also acknowledge that even perfect systems fail and that people make mistakes and may accidentally leave medication out, within reach, or otherwise unsecured. If that happens, and someone were to intentionally or unintentionally get into that medication and potentially overdose as a result, we want to have that reversal medication immediately available to reverse the overdose.”

In nearly all cases (91%), EMS provided advanced life support, with only 7.5% patients receiving basic life support and 1.5% receiving specialty critical care. Just under a third (29%) of the dispatch calls were for “overdose/poisoning/ingestion.” Other dispatch calls included “unconscious/fainting/near-fainting” (21%) or “cardiac arrest/death” (17%), but the frequency of each dispatch label varied by age groups.

For example, 38% of calls for infants were for cardiac arrest, compared with 15% of calls for older teens and 18% of calls for 6-12 year olds. An overdose/poisoning dispatch was meanwhile more common for teens (32%) than for infants (13%), younger children (23%), and older children/tweens (18%). Other dispatch complaints included “sick person/person down/unknown problem” (12%) and “breathing problem” (5%).

A possible reason for these variations is that “an overdose might be mistaken for another medical emergency, or vice versa, because opioid poisonings can be challenging to recognize, especially in young children and in the pediatric population,” Gaw said. “Both the public and emergency responders should maintain a high level of suspicion” of possible overdose for children with the signs or symptoms of it, such as low breathing, unresponsiveness, or small pupils.

In most cases (87%), the patient was not in cardiac arrest, though the patient had entered cardiac arrest before EMS’s arrival in 11.5% of cases. Two thirds of cases only involved one dose of naloxone, while the other 33% involved two doses.

Ryan Marino, MD, an addiction medicine specialist and an associate professor of emergency medicine at Case Western Reserve University School of Medicine in Cleveland, Ohio, who was not involved in the study, took note of the high proportion of cases in which two doses were administered.

“While there is, in my professional opinion, almost no downside to giving naloxone in situations like this, and everybody should have it available and know how to use it, I would caution people on the risk of anchor bias, especially when more than two doses of naloxone are given, since we know that one should be an effective amount for any known opioid overdose,” Marino said. Anchoring bias refers to the tendency for individuals to rely more heavily on the first piece of information they receive about a topic or situation.

“For first responders and healthcare professionals, the importance of additional resuscitation measures like oxygenation and ventilation are just as crucial,” Marino said. “People should not be discouraged if someone doesn’t immediately respond to naloxone as overdose physiology can cause mental status to stay impaired for other reasons beyond direct drug effect, such as hypercarbia, but continue to seek and/or provide additional emergency care in these situations.”

Patients improved after one dose in just over half the cases (54%), and their conditions were unchanged in 46% of cases. There were only 11 cases in which the patient’s condition worsened after a naloxone dose (0.2%). Most of the cases (88%) were transported by EMS, and there were 13 total deaths at the scene (0.2%).

Nichols found the low incidence of worsening clinical status particularly striking. “This is further evidence of a critically important point — naloxone is purely an opioid antagonist, and only binds to opioid receptors, such that if a person has not overdosed on opioids or does not otherwise have opioids in their system, naloxone will not have a significant effect and will not cause them harm,” Nichols said.

“The most common causes of harm are due to rapid reversal of overdose and the potential risks involved in the rapid reversal of opioid effects and potentially precipitating withdrawal, and as this paper demonstrates, these are exceedingly rare,” he said. “Given that, we should have an incredibly low barrier to administer naloxone appropriately.”

The study was limited by inability to know how many true pediatric opioid poisonings are managed by EMS, so future research could look at linking EMS and emergency room hospital databases.
 

Improved Self-Efficacy in Teens

Another study showed that a peer-to-peer training program increased teens’ knowledge about overdoses from 34% before training to 79% after (P < .0001), and it substantially improved their confidence in recognizing an overdose and administering naloxone.

Nichols said the study shows the importance of ensuring “that adolescents know how to keep themselves and their friends safe in the case that they or anyone they know does end up using illicit substances which either intentionally or unintentionally contain opioids.”

This study assessed a training program with 206 students in a Los Angeles County high school who were trained by their peers between November 2023 and March 2024. The training included trends in teen overdose deaths, defining what opioids and fentanyl are, recognizing an overdose, and responding to one with naloxone.

The teens were an average 16 years old, about evenly split between boys and girls, and mostly in 11th (40%) or 12th (28%) grade, though nearly a third (29%) were 9th graders.

The students’ knowledge about fentanyl’s presence in counterfeit pills increased from 21% before the training to 68% afterward, and their correct identification of an overdose increased from 47% of participants to 90%.

The students’ confidence and attitudes toward helping with an overdose also improved substantially after the training. About two thirds agreed that non-medical people should be able to carry naloxone before the training, and that rose to 88% agreeing after the training. The proportion who agreed they would be willing to assist in an overdose rose from 77% before to 89% after training.

More dramatically, the teens’ confidence after training more than doubled in recognizing an overdose (from 31% to 81%) and more than tripled in their ability to give naloxone during an overdose (from 26% to 83%).

“The critical piece to keep in mind is that the concern about opioid overdose is respiratory depression leading to a lack of oxygen getting to the brain,” Nichols explained. “In the event of an overdose, time is brain — the longer the brain is deprived of oxygen, the lower the chance of survival. There is no specific time at which naloxone would become less effective at reversing an overdose.”

Therefore, people do not need to know the exact time that someone may have overdosed or how long they have been passed out in order to administer naloxone, he said. “The sooner naloxone is administered to someone who is unresponsive and who may have overdosed on opioids, the higher the likelihood of a successful reversal of an overdose and of saving a life.”

The peer-to-peer program was sponsored by the CARLOW Center for Medical Innovation, and the EMS study used no external funding. The authors of both studies and Marino had no disclosures. Nichols has consulted or clinically advised TV shows and health tech startup companies and has no disclosures related to naloxone or the pharmaceutical industry.
 

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

We pediatricians consider ourselves as compassionate professionals, optimistic about the potential of all children. This is reflected in the American Academy of Pediatrics’ equity statement of “its mission to ensure the health and well-being of all children. This includes promoting nurturing, inclusive environments and actively opposing intolerance, bigotry, bias, and discrimination.”

A committee of the Developmental Behavioral Pediatric Network developed and published a consensus statement specifically about problems in the care of individuals with neurodevelopmental disabilities (NDD) called the Supporting Access for Everyone (SAFE) initiative. All of us care for children with NDD as one in six are affected with these conditions that impact cognition, communication, motor, social, and/or behavior skills such as autism, ADHD, intellectual disabilities (ID), learning disorders, hearing or vision impairment, and motor disabilities such as cerebral palsy. Children with NDD are overrepresented in our daily practice schedule due to their multiple medical, behavioral, and social needs. NDD are also more common among marginalized children with racial, ethnic, sexual, or gender identity minority status compounding their difficulties in accessing quality care.

NDD present similar challenges to care as other chronic conditions that also require longer visits, more documentation, long-term monitoring, team-based care, care coordination, and often referrals. But most chronic medical conditions we care for such as asthma, diabetes, cancer, hypertension, and renal disease have clear national guidelines and appropriate billing codes and are not stigmatizing. Most also do not intrinsically affect the nervous system or cause disability as for NDD that alter the behavioral presentation of the individual in a way that changes their care.

Discrimination against individuals with NDD and other disabilities, called “ableism,” can take many forms: assuming a child with communication difficulty or ID is unable to understand explanations about their care; the presence of one NDD condition ending the clinician’s search for other issues; complicated problems or difficult behaviors in the medical setting truncating care, etc. To be equitable in the care of individuals with NDD we need to be aware of discrimination and also go beyond guidelines to personalize the accommodations we advise and make.
 

Adjustments Needed for Special Needs

As pediatricians we already adjust our interactions, starting instinctively, to the development level of the child we perceive before us. We approach infants slowly and softly, we speak in shorter sentences to toddlers, we joke around with school-aged children, and we take extra care about privacy with teens. This serves the relationships well for neurotypical children. But our (and our staff’s) perceptions of children with autism, ID, genetic syndromes that include NDD, or motor disabilities based on their behavioral presentation may not accurately recognize or accommodate their abilities or needs. Communication and environmental adjustments may need to be much more individualized to provide respectful care, comfort and even safety.

As an example, at this time 1 in 36 children have autism with or without ID. Defining features of autism include differences in social communication, repetitive or restrictive interests or behaviors, and hypersensitivity to the environment plus any coexisting conditions such as anxiety and hyperactivity. But most children with autism have completely age appropriate and typical physical appearance and their underlying condition may not even be known. The office setting, without special attention to the needs of a child with autism, may be frightening, loud, too bright, too crowded, fast paced, and confusing. The result of their sensitivities and difficulty communicating may lead to increased agitation, repetitive behaviors (sometimes called “stimming”), shrieking, attempts to escape the room, refusal to allow for vital signs or undressing, even aggression. Strategies for calming a neurotypical child such as talking or touching may make matters worse instead of better. We need help from the child and family and a plan to optimize their medical encounters.

If not adequately accommodated, children with many varieties of NDD end up not getting all the routine healthcare they need (eg vaccinations, blood tests, vital signs, even complete physical exams including dental) as well as having more adverse events during health care, including traumatizing seclusion, not allowing a support person to be present, restraint, injuries, and accidents. When more complex procedures are needed, eg x-ray, MRI, EEG, lab studies, or surgery, successful outcomes may be lower. Children with NDD have higher rates of often avoidable morbidity and mortality than those without, in part due to these barriers to complete care. While environmental accommodations to wheelchair users for accessibility has greatly improved in recent years, access to other kinds of individualized accommodations have lagged behind.
 

Accommodation Planning

There are a variety of factors that need to be taken into consideration in accommodating an individual with NDD. The family becomes the expert, along with the child, in knowing the child’s triggers, preferences, abilities, and level of understanding to accept and consent for care. An accommodation plan should be created using shared and supported decision making with the family and child and allowing for child preferences, regardless of their ability level, whenever possible. Development of an accommodation plan may benefit from multidisciplinary input, eg psychology, physical therapy, speech pathology, depending on the child’s needs and the practice’s ability to adapt.

The SAFE initiative is in the process of creating a checklist aiming to facilitate a description being created for each individual to help plan for a successful medical encounter while optimizing the child’s comfort, participation, and safety. While the checklist is not yet ready, we can start now by asking families and children in preparation for or at the start of a visit about their needs and writing a shared document that can also be placed in the electronic health record for the entire care team for informing care going forward.

It is especially important for the family to keep a copy of the care plan and for it to be sent as part of referrals for procedures or specialty visits so that the professionals can prepare and adapt the encounter. An excellent example is a how some hospitals schedule a practice visit for the child to experience the sights and sounds and people the child will encounter, for example, before an EEG, when nothing is required of the child. Scheduling the actual procedure at times of day when clinics are less crowded and wait times are shorter can improve the chances of success.

Some categories and details that might be included in an accommodation plan are listed below:

You might start the plan with the child’s preferred name/nickname, family member or support person names, and diagnoses along with a brief overview of the child’s level of functioning. Then list categories of needs and preferences along with suggestions or requests.

• Motor: Does the child have or need assistance entering the building, visit room, bathroom, or transferring to the exam table? What kind of assistance, if any, and by whom?
• Sensory: Is the child disturbed by noise, lights, or being touched? Does the child want to use equipment to be comfortable such as headphones, earplugs, or sunglasses or need a quiet room, care without perfumes, or dimmed lighting? Does the child typically refuse aspects of the physical examination?
• Behavioral regulation: What helps the child to stay calm? Are there certain triggers to becoming upset? Are there early cues that an upset is coming? What and who can help in the case of an upset?
• Habits/preferences: Are there certain comfort objects or habits your child needs? Are there habits your child needs to do, such as a certain order of events, or use of social stories or pictures, to cooperate or feel comfortable?
• Communication: How does the child make his/her needs known? Does the child/family speak English or another language? Does he/she use sign language or an augmentative communication device? What level of understanding does your child have; for example, similar to what age for a typical child? Is there a care plan with accommodations already available that needs review or needs revision with the child’s development or is a new one needed? Was the care plan developed including the child’s participation and assent or is more collaboration needed?
• History: Has your child had any very upsetting experiences in healthcare settings? What happened? Has the trauma been addressed? Are there reminders of the trauma that should be avoided?
• Other: Are there other things we should know about your child as an individual to provide the best care?

There are many actions needed to do better at ensuring equitable care for individuals with NDD. We should educate our office and medical staff about NDD in children and the importance of accommodating their needs, and ways to do it. The morning huddle can be used to remind staff of upcoming visits of children who may need accommodations. We then need to use quality improvement methods to check in periodically on how the changes are working for the children, families, and practice in order to continually improve.

The overall healthcare system also needs to change. Billing codes should reflect the time, complexity of accommodations, and documentation that were required for care. Episodes of the visit may need to be broken up within the day or over several days to allow the child to practice, calm down, and cooperate and this should be accounted for in billing. Given that NDD are generally lifelong conditions, payment systems that require measures of progress such as value-based payment based on improved outcomes will need to be adjusted to measure quality of care rather than significant progress.

We need to advocate for both individual children and for system changes to work toward equity of care for those with disabilities to make their lives more comfortable as well as ours.

Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].

We pediatricians consider ourselves as compassionate professionals, optimistic about the potential of all children. This is reflected in the American Academy of Pediatrics’ equity statement of “its mission to ensure the health and well-being of all children. This includes promoting nurturing, inclusive environments and actively opposing intolerance, bigotry, bias, and discrimination.”

A committee of the Developmental Behavioral Pediatric Network developed and published a consensus statement specifically about problems in the care of individuals with neurodevelopmental disabilities (NDD) called the Supporting Access for Everyone (SAFE) initiative. All of us care for children with NDD as one in six are affected with these conditions that impact cognition, communication, motor, social, and/or behavior skills such as autism, ADHD, intellectual disabilities (ID), learning disorders, hearing or vision impairment, and motor disabilities such as cerebral palsy. Children with NDD are overrepresented in our daily practice schedule due to their multiple medical, behavioral, and social needs. NDD are also more common among marginalized children with racial, ethnic, sexual, or gender identity minority status compounding their difficulties in accessing quality care.

NDD present similar challenges to care as other chronic conditions that also require longer visits, more documentation, long-term monitoring, team-based care, care coordination, and often referrals. But most chronic medical conditions we care for such as asthma, diabetes, cancer, hypertension, and renal disease have clear national guidelines and appropriate billing codes and are not stigmatizing. Most also do not intrinsically affect the nervous system or cause disability as for NDD that alter the behavioral presentation of the individual in a way that changes their care.

Discrimination against individuals with NDD and other disabilities, called “ableism,” can take many forms: assuming a child with communication difficulty or ID is unable to understand explanations about their care; the presence of one NDD condition ending the clinician’s search for other issues; complicated problems or difficult behaviors in the medical setting truncating care, etc. To be equitable in the care of individuals with NDD we need to be aware of discrimination and also go beyond guidelines to personalize the accommodations we advise and make.
 

Adjustments Needed for Special Needs

As pediatricians we already adjust our interactions, starting instinctively, to the development level of the child we perceive before us. We approach infants slowly and softly, we speak in shorter sentences to toddlers, we joke around with school-aged children, and we take extra care about privacy with teens. This serves the relationships well for neurotypical children. But our (and our staff’s) perceptions of children with autism, ID, genetic syndromes that include NDD, or motor disabilities based on their behavioral presentation may not accurately recognize or accommodate their abilities or needs. Communication and environmental adjustments may need to be much more individualized to provide respectful care, comfort and even safety.

As an example, at this time 1 in 36 children have autism with or without ID. Defining features of autism include differences in social communication, repetitive or restrictive interests or behaviors, and hypersensitivity to the environment plus any coexisting conditions such as anxiety and hyperactivity. But most children with autism have completely age appropriate and typical physical appearance and their underlying condition may not even be known. The office setting, without special attention to the needs of a child with autism, may be frightening, loud, too bright, too crowded, fast paced, and confusing. The result of their sensitivities and difficulty communicating may lead to increased agitation, repetitive behaviors (sometimes called “stimming”), shrieking, attempts to escape the room, refusal to allow for vital signs or undressing, even aggression. Strategies for calming a neurotypical child such as talking or touching may make matters worse instead of better. We need help from the child and family and a plan to optimize their medical encounters.

If not adequately accommodated, children with many varieties of NDD end up not getting all the routine healthcare they need (eg vaccinations, blood tests, vital signs, even complete physical exams including dental) as well as having more adverse events during health care, including traumatizing seclusion, not allowing a support person to be present, restraint, injuries, and accidents. When more complex procedures are needed, eg x-ray, MRI, EEG, lab studies, or surgery, successful outcomes may be lower. Children with NDD have higher rates of often avoidable morbidity and mortality than those without, in part due to these barriers to complete care. While environmental accommodations to wheelchair users for accessibility has greatly improved in recent years, access to other kinds of individualized accommodations have lagged behind.
 

Accommodation Planning

There are a variety of factors that need to be taken into consideration in accommodating an individual with NDD. The family becomes the expert, along with the child, in knowing the child’s triggers, preferences, abilities, and level of understanding to accept and consent for care. An accommodation plan should be created using shared and supported decision making with the family and child and allowing for child preferences, regardless of their ability level, whenever possible. Development of an accommodation plan may benefit from multidisciplinary input, eg psychology, physical therapy, speech pathology, depending on the child’s needs and the practice’s ability to adapt.

The SAFE initiative is in the process of creating a checklist aiming to facilitate a description being created for each individual to help plan for a successful medical encounter while optimizing the child’s comfort, participation, and safety. While the checklist is not yet ready, we can start now by asking families and children in preparation for or at the start of a visit about their needs and writing a shared document that can also be placed in the electronic health record for the entire care team for informing care going forward.

It is especially important for the family to keep a copy of the care plan and for it to be sent as part of referrals for procedures or specialty visits so that the professionals can prepare and adapt the encounter. An excellent example is a how some hospitals schedule a practice visit for the child to experience the sights and sounds and people the child will encounter, for example, before an EEG, when nothing is required of the child. Scheduling the actual procedure at times of day when clinics are less crowded and wait times are shorter can improve the chances of success.

Some categories and details that might be included in an accommodation plan are listed below:

You might start the plan with the child’s preferred name/nickname, family member or support person names, and diagnoses along with a brief overview of the child’s level of functioning. Then list categories of needs and preferences along with suggestions or requests.

• Motor: Does the child have or need assistance entering the building, visit room, bathroom, or transferring to the exam table? What kind of assistance, if any, and by whom?
• Sensory: Is the child disturbed by noise, lights, or being touched? Does the child want to use equipment to be comfortable such as headphones, earplugs, or sunglasses or need a quiet room, care without perfumes, or dimmed lighting? Does the child typically refuse aspects of the physical examination?
• Behavioral regulation: What helps the child to stay calm? Are there certain triggers to becoming upset? Are there early cues that an upset is coming? What and who can help in the case of an upset?
• Habits/preferences: Are there certain comfort objects or habits your child needs? Are there habits your child needs to do, such as a certain order of events, or use of social stories or pictures, to cooperate or feel comfortable?
• Communication: How does the child make his/her needs known? Does the child/family speak English or another language? Does he/she use sign language or an augmentative communication device? What level of understanding does your child have; for example, similar to what age for a typical child? Is there a care plan with accommodations already available that needs review or needs revision with the child’s development or is a new one needed? Was the care plan developed including the child’s participation and assent or is more collaboration needed?
• History: Has your child had any very upsetting experiences in healthcare settings? What happened? Has the trauma been addressed? Are there reminders of the trauma that should be avoided?
• Other: Are there other things we should know about your child as an individual to provide the best care?

There are many actions needed to do better at ensuring equitable care for individuals with NDD. We should educate our office and medical staff about NDD in children and the importance of accommodating their needs, and ways to do it. The morning huddle can be used to remind staff of upcoming visits of children who may need accommodations. We then need to use quality improvement methods to check in periodically on how the changes are working for the children, families, and practice in order to continually improve.

The overall healthcare system also needs to change. Billing codes should reflect the time, complexity of accommodations, and documentation that were required for care. Episodes of the visit may need to be broken up within the day or over several days to allow the child to practice, calm down, and cooperate and this should be accounted for in billing. Given that NDD are generally lifelong conditions, payment systems that require measures of progress such as value-based payment based on improved outcomes will need to be adjusted to measure quality of care rather than significant progress.

We need to advocate for both individual children and for system changes to work toward equity of care for those with disabilities to make their lives more comfortable as well as ours.

Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].

We pediatricians consider ourselves as compassionate professionals, optimistic about the potential of all children. This is reflected in the American Academy of Pediatrics’ equity statement of “its mission to ensure the health and well-being of all children. This includes promoting nurturing, inclusive environments and actively opposing intolerance, bigotry, bias, and discrimination.”

A committee of the Developmental Behavioral Pediatric Network developed and published a consensus statement specifically about problems in the care of individuals with neurodevelopmental disabilities (NDD) called the Supporting Access for Everyone (SAFE) initiative. All of us care for children with NDD as one in six are affected with these conditions that impact cognition, communication, motor, social, and/or behavior skills such as autism, ADHD, intellectual disabilities (ID), learning disorders, hearing or vision impairment, and motor disabilities such as cerebral palsy. Children with NDD are overrepresented in our daily practice schedule due to their multiple medical, behavioral, and social needs. NDD are also more common among marginalized children with racial, ethnic, sexual, or gender identity minority status compounding their difficulties in accessing quality care.

NDD present similar challenges to care as other chronic conditions that also require longer visits, more documentation, long-term monitoring, team-based care, care coordination, and often referrals. But most chronic medical conditions we care for such as asthma, diabetes, cancer, hypertension, and renal disease have clear national guidelines and appropriate billing codes and are not stigmatizing. Most also do not intrinsically affect the nervous system or cause disability as for NDD that alter the behavioral presentation of the individual in a way that changes their care.

Discrimination against individuals with NDD and other disabilities, called “ableism,” can take many forms: assuming a child with communication difficulty or ID is unable to understand explanations about their care; the presence of one NDD condition ending the clinician’s search for other issues; complicated problems or difficult behaviors in the medical setting truncating care, etc. To be equitable in the care of individuals with NDD we need to be aware of discrimination and also go beyond guidelines to personalize the accommodations we advise and make.
 

Adjustments Needed for Special Needs

As pediatricians we already adjust our interactions, starting instinctively, to the development level of the child we perceive before us. We approach infants slowly and softly, we speak in shorter sentences to toddlers, we joke around with school-aged children, and we take extra care about privacy with teens. This serves the relationships well for neurotypical children. But our (and our staff’s) perceptions of children with autism, ID, genetic syndromes that include NDD, or motor disabilities based on their behavioral presentation may not accurately recognize or accommodate their abilities or needs. Communication and environmental adjustments may need to be much more individualized to provide respectful care, comfort and even safety.

As an example, at this time 1 in 36 children have autism with or without ID. Defining features of autism include differences in social communication, repetitive or restrictive interests or behaviors, and hypersensitivity to the environment plus any coexisting conditions such as anxiety and hyperactivity. But most children with autism have completely age appropriate and typical physical appearance and their underlying condition may not even be known. The office setting, without special attention to the needs of a child with autism, may be frightening, loud, too bright, too crowded, fast paced, and confusing. The result of their sensitivities and difficulty communicating may lead to increased agitation, repetitive behaviors (sometimes called “stimming”), shrieking, attempts to escape the room, refusal to allow for vital signs or undressing, even aggression. Strategies for calming a neurotypical child such as talking or touching may make matters worse instead of better. We need help from the child and family and a plan to optimize their medical encounters.

If not adequately accommodated, children with many varieties of NDD end up not getting all the routine healthcare they need (eg vaccinations, blood tests, vital signs, even complete physical exams including dental) as well as having more adverse events during health care, including traumatizing seclusion, not allowing a support person to be present, restraint, injuries, and accidents. When more complex procedures are needed, eg x-ray, MRI, EEG, lab studies, or surgery, successful outcomes may be lower. Children with NDD have higher rates of often avoidable morbidity and mortality than those without, in part due to these barriers to complete care. While environmental accommodations to wheelchair users for accessibility has greatly improved in recent years, access to other kinds of individualized accommodations have lagged behind.
 

Accommodation Planning

There are a variety of factors that need to be taken into consideration in accommodating an individual with NDD. The family becomes the expert, along with the child, in knowing the child’s triggers, preferences, abilities, and level of understanding to accept and consent for care. An accommodation plan should be created using shared and supported decision making with the family and child and allowing for child preferences, regardless of their ability level, whenever possible. Development of an accommodation plan may benefit from multidisciplinary input, eg psychology, physical therapy, speech pathology, depending on the child’s needs and the practice’s ability to adapt.

The SAFE initiative is in the process of creating a checklist aiming to facilitate a description being created for each individual to help plan for a successful medical encounter while optimizing the child’s comfort, participation, and safety. While the checklist is not yet ready, we can start now by asking families and children in preparation for or at the start of a visit about their needs and writing a shared document that can also be placed in the electronic health record for the entire care team for informing care going forward.

It is especially important for the family to keep a copy of the care plan and for it to be sent as part of referrals for procedures or specialty visits so that the professionals can prepare and adapt the encounter. An excellent example is a how some hospitals schedule a practice visit for the child to experience the sights and sounds and people the child will encounter, for example, before an EEG, when nothing is required of the child. Scheduling the actual procedure at times of day when clinics are less crowded and wait times are shorter can improve the chances of success.

Some categories and details that might be included in an accommodation plan are listed below:

You might start the plan with the child’s preferred name/nickname, family member or support person names, and diagnoses along with a brief overview of the child’s level of functioning. Then list categories of needs and preferences along with suggestions or requests.

• Motor: Does the child have or need assistance entering the building, visit room, bathroom, or transferring to the exam table? What kind of assistance, if any, and by whom?
• Sensory: Is the child disturbed by noise, lights, or being touched? Does the child want to use equipment to be comfortable such as headphones, earplugs, or sunglasses or need a quiet room, care without perfumes, or dimmed lighting? Does the child typically refuse aspects of the physical examination?
• Behavioral regulation: What helps the child to stay calm? Are there certain triggers to becoming upset? Are there early cues that an upset is coming? What and who can help in the case of an upset?
• Habits/preferences: Are there certain comfort objects or habits your child needs? Are there habits your child needs to do, such as a certain order of events, or use of social stories or pictures, to cooperate or feel comfortable?
• Communication: How does the child make his/her needs known? Does the child/family speak English or another language? Does he/she use sign language or an augmentative communication device? What level of understanding does your child have; for example, similar to what age for a typical child? Is there a care plan with accommodations already available that needs review or needs revision with the child’s development or is a new one needed? Was the care plan developed including the child’s participation and assent or is more collaboration needed?
• History: Has your child had any very upsetting experiences in healthcare settings? What happened? Has the trauma been addressed? Are there reminders of the trauma that should be avoided?
• Other: Are there other things we should know about your child as an individual to provide the best care?

There are many actions needed to do better at ensuring equitable care for individuals with NDD. We should educate our office and medical staff about NDD in children and the importance of accommodating their needs, and ways to do it. The morning huddle can be used to remind staff of upcoming visits of children who may need accommodations. We then need to use quality improvement methods to check in periodically on how the changes are working for the children, families, and practice in order to continually improve.

The overall healthcare system also needs to change. Billing codes should reflect the time, complexity of accommodations, and documentation that were required for care. Episodes of the visit may need to be broken up within the day or over several days to allow the child to practice, calm down, and cooperate and this should be accounted for in billing. Given that NDD are generally lifelong conditions, payment systems that require measures of progress such as value-based payment based on improved outcomes will need to be adjusted to measure quality of care rather than significant progress.

We need to advocate for both individual children and for system changes to work toward equity of care for those with disabilities to make their lives more comfortable as well as ours.

Dr. Howard is assistant professor of pediatrics at The Johns Hopkins University School of Medicine, Baltimore, and creator of CHADIS. She had no other relevant disclosures. Dr. Howard’s contribution to this publication was as a paid expert to MDedge News. E-mail her at [email protected].

The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
 

Flawed Reviews

A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.

As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”

Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.

“There is indeed a problem with research reliability, but it’s not as widespread or severe as some portray,” said Daniele Fanelli, a metascientist at the London School of Economics and Political Science in England. Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
 

Lack of Awareness

A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.

While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”

Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.

A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.

The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
 

Fanelli’s Perspective

Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.

“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
 

Flawed Reviews

A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.

As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”

Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.

“There is indeed a problem with research reliability, but it’s not as widespread or severe as some portray,” said Daniele Fanelli, a metascientist at the London School of Economics and Political Science in England. Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
 

Lack of Awareness

A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.

While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”

Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.

A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.

The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
 

Fanelli’s Perspective

Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.

“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
 

Flawed Reviews

A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.

As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”

Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.

“There is indeed a problem with research reliability, but it’s not as widespread or severe as some portray,” said Daniele Fanelli, a metascientist at the London School of Economics and Political Science in England. Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
 

Lack of Awareness

A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.

While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”

Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.

A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.

The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
 

Fanelli’s Perspective

Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.

“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.

This story was translated from Univadis Italy using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Summary:

In this segment, the speaker discusses how AI is revolutionizing the drug repurposing process. Previously, drug repurposing was limited by manual research on individual diseases and drugs. With AI, scientists can now analyze a vast array of drugs and diseases simultaneously, generating a ranking system based on the likelihood of success. The Center for Cytokine Storm Treatment and Laboratory, along with the platform Every Cure, uses AI to score 3000 drugs against 18,000 diseases. This platform dramatically reduces the time and resources required for drug repurposing, enabling predictions that can be tested in a fraction of the time.
 

Key Takeaways:

AI is accelerating the drug repurposing process, offering faster and more comprehensive analysis of possible drug-disease matches.

The AI-based platform assigns a likelihood score to each potential match, streamlining the process for testing and validation.

The ability to analyze global biomedical knowledge in 24 hours is unprecedented, reducing research costs and increasing the speed of drug discovery.
 

Our Editors Also Recommend: 

AI’s Drug Revolution, Part 1: Faster Trials and Approvals

From AI to Obesity Drugs to Soaring Costs: Medscape Hot Topics in the Medical Profession Report 2024

AI Voice Analysis for Diabetes Screening Shows Promise

To see the full event recording, click here.
 

A version of this article appeared on Medscape.com.

Summary:

In this segment, the speaker discusses how AI is revolutionizing the drug repurposing process. Previously, drug repurposing was limited by manual research on individual diseases and drugs. With AI, scientists can now analyze a vast array of drugs and diseases simultaneously, generating a ranking system based on the likelihood of success. The Center for Cytokine Storm Treatment and Laboratory, along with the platform Every Cure, uses AI to score 3000 drugs against 18,000 diseases. This platform dramatically reduces the time and resources required for drug repurposing, enabling predictions that can be tested in a fraction of the time.
 

Key Takeaways:

AI is accelerating the drug repurposing process, offering faster and more comprehensive analysis of possible drug-disease matches.

The AI-based platform assigns a likelihood score to each potential match, streamlining the process for testing and validation.

The ability to analyze global biomedical knowledge in 24 hours is unprecedented, reducing research costs and increasing the speed of drug discovery.
 

Our Editors Also Recommend: 

AI’s Drug Revolution, Part 1: Faster Trials and Approvals

From AI to Obesity Drugs to Soaring Costs: Medscape Hot Topics in the Medical Profession Report 2024

AI Voice Analysis for Diabetes Screening Shows Promise

To see the full event recording, click here.
 

A version of this article appeared on Medscape.com.

Summary:

In this segment, the speaker discusses how AI is revolutionizing the drug repurposing process. Previously, drug repurposing was limited by manual research on individual diseases and drugs. With AI, scientists can now analyze a vast array of drugs and diseases simultaneously, generating a ranking system based on the likelihood of success. The Center for Cytokine Storm Treatment and Laboratory, along with the platform Every Cure, uses AI to score 3000 drugs against 18,000 diseases. This platform dramatically reduces the time and resources required for drug repurposing, enabling predictions that can be tested in a fraction of the time.
 

Key Takeaways:

AI is accelerating the drug repurposing process, offering faster and more comprehensive analysis of possible drug-disease matches.

The AI-based platform assigns a likelihood score to each potential match, streamlining the process for testing and validation.

The ability to analyze global biomedical knowledge in 24 hours is unprecedented, reducing research costs and increasing the speed of drug discovery.
 

Our Editors Also Recommend: 

AI’s Drug Revolution, Part 1: Faster Trials and Approvals

From AI to Obesity Drugs to Soaring Costs: Medscape Hot Topics in the Medical Profession Report 2024

AI Voice Analysis for Diabetes Screening Shows Promise

To see the full event recording, click here.
 

A version of this article appeared on Medscape.com.

Black box warnings added to antidepressant medications on increased risk for suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people, a new analysis suggests. 

Investigators said the totality of evidence supports “reevaluation and possible replacement” of the US Food and Drug Administration (FDA) black box warning with routine warnings in product labeling. 

“The sudden, simultaneous, and sweeping effects of these warnings — the reduction in depression treatment and increase in suicide — are documented across 14 years of strong research. The consistency in observed harms and absence of observed benefits after the black box warnings indicate this is not a coincidence,” lead author Stephen Soumerai, ScD, professor of population medicine, Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, said in a news release. 

The study was published online in Health Affairs. 
 

How Did We Get Here?

In October 2003, the FDA warned that antidepressants may be associated with suicidality among people younger than age 18 years soon after starting treatment. In January 2005, the FDA required a permanent black box warning of this risk on product labels and in television and print advertising for all antidepressant drugs. 

In May 2007, the FDA expanded the 2005 black box warning to include young adults through age 24, and this broader warning remains in effect today. 

Dr. Soumerai and colleagues evaluated the intended and unintended outcomes of the youth antidepressant warnings through a systematic review of “the most credible evidence in the field,” Dr. Soumerai said. 

Through an exhaustive literature search, the researchers identified 34 studies of depression and suicide-related outcomes published in peer-reviewed journals after the warnings were issued. 

Eleven of these studies measured abrupt changes in outcome trends following the warnings and were included in their analyses. These outcomes included monitoring for suicidality, physician visits for depression, depression diagnoses, psychotherapy visits, antidepressant treatment and use and psychotropic drug poisonings (a proxy for suicide attempts), and suicide deaths. 
 

More Harms Than Benefits

Four studies, with more than 12 million patients, found “consistent evidence of sudden and substantial” long-term declines in doctor visits for depression and depression diagnoses after the FDA warnings, the study team noted.

These studies showed increases in physician visits for depression and depression diagnoses in the years before the warnings and abrupt, sustained declines, ranging from 20% to 45%, in visits and diagnoses after the warnings. “Some spillover occurred in comparison groups of adults, who were not targeted by the FDA warnings,” the study team said. 

Seven studies revealed evidence that the FDA warnings were followed by abrupt reductions in antidepressant treatment and use, ranging from 20% to 50%. Most of these studies showed increasing use of antidepressants in the years before the FDA warnings, followed by abrupt and sustained reductions in use afterward. 

Three studies found evidence of declining or flat trends in psychotropic drug poisonings and suicide deaths among pediatric patients before the warnings, followed by abrupt increases in these trends after the warnings were issued. 

The intent of the warnings was to increase physician monitoring of suicidality of patients treated with antidepressants, but the data suggest that this did not occur. 

Less than 5% of pediatric patients were monitored in accordance with FDA’s recommended contact schedule recommendations after the warnings were issued. This low rate was unchanged from the rate before the warnings. 

No study documented improvements in mental health care or declines in suicide attempts or suicides after the warnings went into effect. 

“The overwhelming evidence suggests that the ongoing use of these warnings may result in more harms than benefits,” the authors wrote. 
 

Concerning Data 

The results are “very concerning and provide reason to pause, rethink, and possibly recalibrate boxed warning recommendations as it relates to antidepressants in younger populations,” said Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Canada, and head of the Mood Disorders Psychopharmacology Unit.

Dr. McIntyre, who wasn’t involved in the study, said the data “unfortunately” provide evidence suggesting that the boxed warning had the “unintended consequence of increasing the likelihood that persons would not receive adequate healthcare for their mental disorder, consequently resulting in unfavorable outcomes, including suicidality.”

He added, “Two decades have now passed with additional information available, which not only appears to recalibrate the initial risk assessment but provides an opportunity for us to reduce the externality of decreasing access to healthcare for people living with mental illness during their youth years.” 

A spokesperson for the FDA said that “generally, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

The study had no commercial funding. Disclosures for the authors are listed with the original article. Dr. McIntyre has received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, and Neurocrine.
 

A version of this article appeared on Medscape.com.

Black box warnings added to antidepressant medications on increased risk for suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people, a new analysis suggests. 

Investigators said the totality of evidence supports “reevaluation and possible replacement” of the US Food and Drug Administration (FDA) black box warning with routine warnings in product labeling. 

“The sudden, simultaneous, and sweeping effects of these warnings — the reduction in depression treatment and increase in suicide — are documented across 14 years of strong research. The consistency in observed harms and absence of observed benefits after the black box warnings indicate this is not a coincidence,” lead author Stephen Soumerai, ScD, professor of population medicine, Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, said in a news release. 

The study was published online in Health Affairs. 
 

How Did We Get Here?

In October 2003, the FDA warned that antidepressants may be associated with suicidality among people younger than age 18 years soon after starting treatment. In January 2005, the FDA required a permanent black box warning of this risk on product labels and in television and print advertising for all antidepressant drugs. 

In May 2007, the FDA expanded the 2005 black box warning to include young adults through age 24, and this broader warning remains in effect today. 

Dr. Soumerai and colleagues evaluated the intended and unintended outcomes of the youth antidepressant warnings through a systematic review of “the most credible evidence in the field,” Dr. Soumerai said. 

Through an exhaustive literature search, the researchers identified 34 studies of depression and suicide-related outcomes published in peer-reviewed journals after the warnings were issued. 

Eleven of these studies measured abrupt changes in outcome trends following the warnings and were included in their analyses. These outcomes included monitoring for suicidality, physician visits for depression, depression diagnoses, psychotherapy visits, antidepressant treatment and use and psychotropic drug poisonings (a proxy for suicide attempts), and suicide deaths. 
 

More Harms Than Benefits

Four studies, with more than 12 million patients, found “consistent evidence of sudden and substantial” long-term declines in doctor visits for depression and depression diagnoses after the FDA warnings, the study team noted.

These studies showed increases in physician visits for depression and depression diagnoses in the years before the warnings and abrupt, sustained declines, ranging from 20% to 45%, in visits and diagnoses after the warnings. “Some spillover occurred in comparison groups of adults, who were not targeted by the FDA warnings,” the study team said. 

Seven studies revealed evidence that the FDA warnings were followed by abrupt reductions in antidepressant treatment and use, ranging from 20% to 50%. Most of these studies showed increasing use of antidepressants in the years before the FDA warnings, followed by abrupt and sustained reductions in use afterward. 

Three studies found evidence of declining or flat trends in psychotropic drug poisonings and suicide deaths among pediatric patients before the warnings, followed by abrupt increases in these trends after the warnings were issued. 

The intent of the warnings was to increase physician monitoring of suicidality of patients treated with antidepressants, but the data suggest that this did not occur. 

Less than 5% of pediatric patients were monitored in accordance with FDA’s recommended contact schedule recommendations after the warnings were issued. This low rate was unchanged from the rate before the warnings. 

No study documented improvements in mental health care or declines in suicide attempts or suicides after the warnings went into effect. 

“The overwhelming evidence suggests that the ongoing use of these warnings may result in more harms than benefits,” the authors wrote. 
 

Concerning Data 

The results are “very concerning and provide reason to pause, rethink, and possibly recalibrate boxed warning recommendations as it relates to antidepressants in younger populations,” said Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Canada, and head of the Mood Disorders Psychopharmacology Unit.

Dr. McIntyre, who wasn’t involved in the study, said the data “unfortunately” provide evidence suggesting that the boxed warning had the “unintended consequence of increasing the likelihood that persons would not receive adequate healthcare for their mental disorder, consequently resulting in unfavorable outcomes, including suicidality.”

He added, “Two decades have now passed with additional information available, which not only appears to recalibrate the initial risk assessment but provides an opportunity for us to reduce the externality of decreasing access to healthcare for people living with mental illness during their youth years.” 

A spokesperson for the FDA said that “generally, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

The study had no commercial funding. Disclosures for the authors are listed with the original article. Dr. McIntyre has received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, and Neurocrine.
 

A version of this article appeared on Medscape.com.

Black box warnings added to antidepressant medications on increased risk for suicidality were associated with a decline in mental health treatment and an increase in suicide attempts and deaths in young people, a new analysis suggests. 

Investigators said the totality of evidence supports “reevaluation and possible replacement” of the US Food and Drug Administration (FDA) black box warning with routine warnings in product labeling. 

“The sudden, simultaneous, and sweeping effects of these warnings — the reduction in depression treatment and increase in suicide — are documented across 14 years of strong research. The consistency in observed harms and absence of observed benefits after the black box warnings indicate this is not a coincidence,” lead author Stephen Soumerai, ScD, professor of population medicine, Harvard Medical School at Harvard Pilgrim Health Care Institute, Boston, said in a news release. 

The study was published online in Health Affairs. 
 

How Did We Get Here?

In October 2003, the FDA warned that antidepressants may be associated with suicidality among people younger than age 18 years soon after starting treatment. In January 2005, the FDA required a permanent black box warning of this risk on product labels and in television and print advertising for all antidepressant drugs. 

In May 2007, the FDA expanded the 2005 black box warning to include young adults through age 24, and this broader warning remains in effect today. 

Dr. Soumerai and colleagues evaluated the intended and unintended outcomes of the youth antidepressant warnings through a systematic review of “the most credible evidence in the field,” Dr. Soumerai said. 

Through an exhaustive literature search, the researchers identified 34 studies of depression and suicide-related outcomes published in peer-reviewed journals after the warnings were issued. 

Eleven of these studies measured abrupt changes in outcome trends following the warnings and were included in their analyses. These outcomes included monitoring for suicidality, physician visits for depression, depression diagnoses, psychotherapy visits, antidepressant treatment and use and psychotropic drug poisonings (a proxy for suicide attempts), and suicide deaths. 
 

More Harms Than Benefits

Four studies, with more than 12 million patients, found “consistent evidence of sudden and substantial” long-term declines in doctor visits for depression and depression diagnoses after the FDA warnings, the study team noted.

These studies showed increases in physician visits for depression and depression diagnoses in the years before the warnings and abrupt, sustained declines, ranging from 20% to 45%, in visits and diagnoses after the warnings. “Some spillover occurred in comparison groups of adults, who were not targeted by the FDA warnings,” the study team said. 

Seven studies revealed evidence that the FDA warnings were followed by abrupt reductions in antidepressant treatment and use, ranging from 20% to 50%. Most of these studies showed increasing use of antidepressants in the years before the FDA warnings, followed by abrupt and sustained reductions in use afterward. 

Three studies found evidence of declining or flat trends in psychotropic drug poisonings and suicide deaths among pediatric patients before the warnings, followed by abrupt increases in these trends after the warnings were issued. 

The intent of the warnings was to increase physician monitoring of suicidality of patients treated with antidepressants, but the data suggest that this did not occur. 

Less than 5% of pediatric patients were monitored in accordance with FDA’s recommended contact schedule recommendations after the warnings were issued. This low rate was unchanged from the rate before the warnings. 

No study documented improvements in mental health care or declines in suicide attempts or suicides after the warnings went into effect. 

“The overwhelming evidence suggests that the ongoing use of these warnings may result in more harms than benefits,” the authors wrote. 
 

Concerning Data 

The results are “very concerning and provide reason to pause, rethink, and possibly recalibrate boxed warning recommendations as it relates to antidepressants in younger populations,” said Roger McIntyre, MD, professor of psychiatry and pharmacology, University of Toronto, Canada, and head of the Mood Disorders Psychopharmacology Unit.

Dr. McIntyre, who wasn’t involved in the study, said the data “unfortunately” provide evidence suggesting that the boxed warning had the “unintended consequence of increasing the likelihood that persons would not receive adequate healthcare for their mental disorder, consequently resulting in unfavorable outcomes, including suicidality.”

He added, “Two decades have now passed with additional information available, which not only appears to recalibrate the initial risk assessment but provides an opportunity for us to reduce the externality of decreasing access to healthcare for people living with mental illness during their youth years.” 

A spokesperson for the FDA said that “generally, the FDA does not comment on specific studies, but evaluates them as part of the body of evidence to further our understanding about a particular issue and assist in our mission to protect public health.”

The study had no commercial funding. Disclosures for the authors are listed with the original article. Dr. McIntyre has received speaker/consultation fees from Lundbeck, Janssen, Alkermes, Neumora Therapeutics, Boehringer Ingelheim, Sage, Biogen, Mitsubishi Tanabe, Purdue, Pfizer, Otsuka, Takeda, and Neurocrine.
 

A version of this article appeared on Medscape.com.

Before the 350 residents finalized their union contract at the University of Vermont (UVM) Medical Center, Burlington, in 2022, Jesse Mostoller, DO, now a third-year pathology resident, recalls hearing about another resident at the hospital who resorted to moonlighting as an Uber driver to make ends meet.

“In Vermont, rent and childcare are expensive,” said Dr. Mostoller, adding that, thanks to union bargaining, first-year residents at UVM are now paid $71,000 per year instead of $61,000. In addition, residents now receive $1800 per year for food (up from $200-$300 annually) and a $1800 annual fund to help pay for board exams that can be carried over for 2 years. “When we were negotiating, the biggest item on our list of demands was to help alleviate the financial pressure residents have been facing for years.”

The UVM residents’ collective bargaining also includes a cap on working hours so that residents don’t work 80 hours a week, paid parental leave, affordable housing, and funds for education and wellness.

These are some of the most common challenges that are faced by residents all over the country, said A. Taylor Walker, MD, MPH, family medicine chief physician at Tufts University School of Medicine/Cambridge Health Alliance in Boston, Massachusetts, and national president of the Committee of Interns and Residents (CIR), which is part of the Service Employees International Union.

For these reasons, residents at Montefiore Medical Center, Stanford Health Care, George Washington University, and the University of Pennsylvania have recently voted to unionize, according to Dr. Walker.

And while there are several small local unions that have picked up residents at local hospitals, CIR is the largest union of physicians in the United States, with a total of 33,000 residents and fellows across the country (15% of the staff at more than 60 hospitals nationwide).

“We’ve doubled in size in the last 4 years,” said Dr. Walker. “The reason is that we’re in a national reckoning on the corporatization of American medicine and the way in which graduate medical education is rooted in a cycle of exploitation that doesn’t center on the health, well-being, or safety of our doctors and ultimately negatively affects our patients.”

Here’s what residents are fighting for — right now.
 

Adequate Parental Leave

Christopher Domanski, MD, a first-year resident in psychiatry at California Pacific Medical Center (CPMC) in San Francisco, is also a new dad to a 5-month-old son and is currently in the sixth week of parental leave. One goal of CPMC’s union, started a year and a half ago, is to expand parental leave to 8 weeks.

“I started as a resident here in mid-June, but the fight with CPMC leaders has been going on for a year and a half,” Dr. Domanski said. “It can feel very frustrating because many times there’s no budge in the conversations we want to have.”

Contract negotiations here continue to be slow — and arduous.

“It goes back and forth,” said Dr. Domanski, who makes about $75,000 a year. “Sometimes they listen to our proposals, but they deny the vast majority or make a paltry increase in salary or time off. It goes like this: We’ll have a negotiation; we’ll talk about it, and then they say, ‘we’re not comfortable doing this’ and it stalls again.”

If a resident hasn’t started a family yet, access to fertility benefits and reproductive healthcare is paramount because most residents are in their 20s and 30s, Dr. Walker said.

“Our reproductive futures are really hindered by what care we have access to and what care is covered,” she added. “We don’t make enough money to pay for reproductive care out of pocket.”
 

Fair Pay

In Boston, the residents at Mass General Brigham certified their union in June 2023, but they still don’t have a contract.

“When I applied for a residency in September 2023, I spoke to the folks here, and I was basically under the impression that we would have a contract by the time I matched,” said Madison Masters, MD, a resident in internal medicine. “We are not there.”

This timeline isn’t unusual — the 1400 Penn Medicine residents who unionized in 2023 only recently secured a tentative union contract at the end of September, and at Stanford, the process to ratify their first contract took 13 months.

Still, the salary issue remains frustrating as resident compensation doesn’t line up with the cost of living or the amount of work residents do, said Dr. Masters, who says starting salaries at Mass General Brigham are $78,500 plus a $10,000 stipend for housing.

“There’s been a long tradition of underpaying residents — we’re treated like trainees, but we’re also a primary labor force,” Dr. Masters said, adding that nurse practitioners and physician assistants are paid almost twice as much as residents — some make $120,000 per year or more, while the salary range for residents nationwide is $49,000-$65,000 per year.

“Every time we discuss the contract and talk about a financial package, they offer a 1.5% raise for the next 3 years while we had asked for closer to 8%,” Dr. Masters said. “Then, when they come back for the next bargaining session, they go up a quarter of a percent each time. Recently, they said we will need to go to a mediator to try and resolve this.”
 

Adequate Healthcare

The biggest — and perhaps the most shocking — ask is for robust health insurance coverage.

“At my hospital, they’re telling us to get Amazon One Medical for health insurance,” Dr. Masters said. “They’re saying it’s hard for anyone to get primary care coverage here.”

Inadequate health insurance is a big issue, as burnout among residents and fellows remains a problem. At UVM, a $10,000 annual wellness stipend has helped address some of these issues. Even so, union members at UVM are planning to return to the table within 18 months to continue their collective bargaining.

The ability to access mental health services anywhere you want is also critical for residents, Dr. Walker said.

“If you can only go to a therapist at your own institution, there is a hesitation to utilize that specialist if that’s even offered,” Dr. Walker said. “Do you want to go to therapy with a colleague? Probably not.”

Ultimately, the residents we spoke to are committed to fighting for their workplace rights — no matter how time-consuming or difficult this has been.

“No administration wants us to have to have a union, but it’s necessary,” Dr. Mostoller said. “As an individual, you don’t have leverage to get a seat at the table, but now we have a seat at the table. We have a wonderful contract, but we’re going to keep fighting to make it even better.”

Paving the way for future residents is a key motivator, too.

“There’s this idea of leaving the campsite cleaner than you found it,” Dr. Mostoller told this news organization. “It’s the same thing here — we’re trying to fix this so that the next generation of residents won’t have to.”

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

Before the 350 residents finalized their union contract at the University of Vermont (UVM) Medical Center, Burlington, in 2022, Jesse Mostoller, DO, now a third-year pathology resident, recalls hearing about another resident at the hospital who resorted to moonlighting as an Uber driver to make ends meet.

“In Vermont, rent and childcare are expensive,” said Dr. Mostoller, adding that, thanks to union bargaining, first-year residents at UVM are now paid $71,000 per year instead of $61,000. In addition, residents now receive $1800 per year for food (up from $200-$300 annually) and a $1800 annual fund to help pay for board exams that can be carried over for 2 years. “When we were negotiating, the biggest item on our list of demands was to help alleviate the financial pressure residents have been facing for years.”

The UVM residents’ collective bargaining also includes a cap on working hours so that residents don’t work 80 hours a week, paid parental leave, affordable housing, and funds for education and wellness.

These are some of the most common challenges that are faced by residents all over the country, said A. Taylor Walker, MD, MPH, family medicine chief physician at Tufts University School of Medicine/Cambridge Health Alliance in Boston, Massachusetts, and national president of the Committee of Interns and Residents (CIR), which is part of the Service Employees International Union.

For these reasons, residents at Montefiore Medical Center, Stanford Health Care, George Washington University, and the University of Pennsylvania have recently voted to unionize, according to Dr. Walker.

And while there are several small local unions that have picked up residents at local hospitals, CIR is the largest union of physicians in the United States, with a total of 33,000 residents and fellows across the country (15% of the staff at more than 60 hospitals nationwide).

“We’ve doubled in size in the last 4 years,” said Dr. Walker. “The reason is that we’re in a national reckoning on the corporatization of American medicine and the way in which graduate medical education is rooted in a cycle of exploitation that doesn’t center on the health, well-being, or safety of our doctors and ultimately negatively affects our patients.”

Here’s what residents are fighting for — right now.
 

Adequate Parental Leave

Christopher Domanski, MD, a first-year resident in psychiatry at California Pacific Medical Center (CPMC) in San Francisco, is also a new dad to a 5-month-old son and is currently in the sixth week of parental leave. One goal of CPMC’s union, started a year and a half ago, is to expand parental leave to 8 weeks.

“I started as a resident here in mid-June, but the fight with CPMC leaders has been going on for a year and a half,” Dr. Domanski said. “It can feel very frustrating because many times there’s no budge in the conversations we want to have.”

Contract negotiations here continue to be slow — and arduous.

“It goes back and forth,” said Dr. Domanski, who makes about $75,000 a year. “Sometimes they listen to our proposals, but they deny the vast majority or make a paltry increase in salary or time off. It goes like this: We’ll have a negotiation; we’ll talk about it, and then they say, ‘we’re not comfortable doing this’ and it stalls again.”

If a resident hasn’t started a family yet, access to fertility benefits and reproductive healthcare is paramount because most residents are in their 20s and 30s, Dr. Walker said.

“Our reproductive futures are really hindered by what care we have access to and what care is covered,” she added. “We don’t make enough money to pay for reproductive care out of pocket.”
 

Fair Pay

In Boston, the residents at Mass General Brigham certified their union in June 2023, but they still don’t have a contract.

“When I applied for a residency in September 2023, I spoke to the folks here, and I was basically under the impression that we would have a contract by the time I matched,” said Madison Masters, MD, a resident in internal medicine. “We are not there.”

This timeline isn’t unusual — the 1400 Penn Medicine residents who unionized in 2023 only recently secured a tentative union contract at the end of September, and at Stanford, the process to ratify their first contract took 13 months.

Still, the salary issue remains frustrating as resident compensation doesn’t line up with the cost of living or the amount of work residents do, said Dr. Masters, who says starting salaries at Mass General Brigham are $78,500 plus a $10,000 stipend for housing.

“There’s been a long tradition of underpaying residents — we’re treated like trainees, but we’re also a primary labor force,” Dr. Masters said, adding that nurse practitioners and physician assistants are paid almost twice as much as residents — some make $120,000 per year or more, while the salary range for residents nationwide is $49,000-$65,000 per year.

“Every time we discuss the contract and talk about a financial package, they offer a 1.5% raise for the next 3 years while we had asked for closer to 8%,” Dr. Masters said. “Then, when they come back for the next bargaining session, they go up a quarter of a percent each time. Recently, they said we will need to go to a mediator to try and resolve this.”
 

Adequate Healthcare

The biggest — and perhaps the most shocking — ask is for robust health insurance coverage.

“At my hospital, they’re telling us to get Amazon One Medical for health insurance,” Dr. Masters said. “They’re saying it’s hard for anyone to get primary care coverage here.”

Inadequate health insurance is a big issue, as burnout among residents and fellows remains a problem. At UVM, a $10,000 annual wellness stipend has helped address some of these issues. Even so, union members at UVM are planning to return to the table within 18 months to continue their collective bargaining.

The ability to access mental health services anywhere you want is also critical for residents, Dr. Walker said.

“If you can only go to a therapist at your own institution, there is a hesitation to utilize that specialist if that’s even offered,” Dr. Walker said. “Do you want to go to therapy with a colleague? Probably not.”

Ultimately, the residents we spoke to are committed to fighting for their workplace rights — no matter how time-consuming or difficult this has been.

“No administration wants us to have to have a union, but it’s necessary,” Dr. Mostoller said. “As an individual, you don’t have leverage to get a seat at the table, but now we have a seat at the table. We have a wonderful contract, but we’re going to keep fighting to make it even better.”

Paving the way for future residents is a key motivator, too.

“There’s this idea of leaving the campsite cleaner than you found it,” Dr. Mostoller told this news organization. “It’s the same thing here — we’re trying to fix this so that the next generation of residents won’t have to.”

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

Before the 350 residents finalized their union contract at the University of Vermont (UVM) Medical Center, Burlington, in 2022, Jesse Mostoller, DO, now a third-year pathology resident, recalls hearing about another resident at the hospital who resorted to moonlighting as an Uber driver to make ends meet.

“In Vermont, rent and childcare are expensive,” said Dr. Mostoller, adding that, thanks to union bargaining, first-year residents at UVM are now paid $71,000 per year instead of $61,000. In addition, residents now receive $1800 per year for food (up from $200-$300 annually) and a $1800 annual fund to help pay for board exams that can be carried over for 2 years. “When we were negotiating, the biggest item on our list of demands was to help alleviate the financial pressure residents have been facing for years.”

The UVM residents’ collective bargaining also includes a cap on working hours so that residents don’t work 80 hours a week, paid parental leave, affordable housing, and funds for education and wellness.

These are some of the most common challenges that are faced by residents all over the country, said A. Taylor Walker, MD, MPH, family medicine chief physician at Tufts University School of Medicine/Cambridge Health Alliance in Boston, Massachusetts, and national president of the Committee of Interns and Residents (CIR), which is part of the Service Employees International Union.

For these reasons, residents at Montefiore Medical Center, Stanford Health Care, George Washington University, and the University of Pennsylvania have recently voted to unionize, according to Dr. Walker.

And while there are several small local unions that have picked up residents at local hospitals, CIR is the largest union of physicians in the United States, with a total of 33,000 residents and fellows across the country (15% of the staff at more than 60 hospitals nationwide).

“We’ve doubled in size in the last 4 years,” said Dr. Walker. “The reason is that we’re in a national reckoning on the corporatization of American medicine and the way in which graduate medical education is rooted in a cycle of exploitation that doesn’t center on the health, well-being, or safety of our doctors and ultimately negatively affects our patients.”

Here’s what residents are fighting for — right now.
 

Adequate Parental Leave

Christopher Domanski, MD, a first-year resident in psychiatry at California Pacific Medical Center (CPMC) in San Francisco, is also a new dad to a 5-month-old son and is currently in the sixth week of parental leave. One goal of CPMC’s union, started a year and a half ago, is to expand parental leave to 8 weeks.

“I started as a resident here in mid-June, but the fight with CPMC leaders has been going on for a year and a half,” Dr. Domanski said. “It can feel very frustrating because many times there’s no budge in the conversations we want to have.”

Contract negotiations here continue to be slow — and arduous.

“It goes back and forth,” said Dr. Domanski, who makes about $75,000 a year. “Sometimes they listen to our proposals, but they deny the vast majority or make a paltry increase in salary or time off. It goes like this: We’ll have a negotiation; we’ll talk about it, and then they say, ‘we’re not comfortable doing this’ and it stalls again.”

If a resident hasn’t started a family yet, access to fertility benefits and reproductive healthcare is paramount because most residents are in their 20s and 30s, Dr. Walker said.

“Our reproductive futures are really hindered by what care we have access to and what care is covered,” she added. “We don’t make enough money to pay for reproductive care out of pocket.”
 

Fair Pay

In Boston, the residents at Mass General Brigham certified their union in June 2023, but they still don’t have a contract.

“When I applied for a residency in September 2023, I spoke to the folks here, and I was basically under the impression that we would have a contract by the time I matched,” said Madison Masters, MD, a resident in internal medicine. “We are not there.”

This timeline isn’t unusual — the 1400 Penn Medicine residents who unionized in 2023 only recently secured a tentative union contract at the end of September, and at Stanford, the process to ratify their first contract took 13 months.

Still, the salary issue remains frustrating as resident compensation doesn’t line up with the cost of living or the amount of work residents do, said Dr. Masters, who says starting salaries at Mass General Brigham are $78,500 plus a $10,000 stipend for housing.

“There’s been a long tradition of underpaying residents — we’re treated like trainees, but we’re also a primary labor force,” Dr. Masters said, adding that nurse practitioners and physician assistants are paid almost twice as much as residents — some make $120,000 per year or more, while the salary range for residents nationwide is $49,000-$65,000 per year.

“Every time we discuss the contract and talk about a financial package, they offer a 1.5% raise for the next 3 years while we had asked for closer to 8%,” Dr. Masters said. “Then, when they come back for the next bargaining session, they go up a quarter of a percent each time. Recently, they said we will need to go to a mediator to try and resolve this.”
 

Adequate Healthcare

The biggest — and perhaps the most shocking — ask is for robust health insurance coverage.

“At my hospital, they’re telling us to get Amazon One Medical for health insurance,” Dr. Masters said. “They’re saying it’s hard for anyone to get primary care coverage here.”

Inadequate health insurance is a big issue, as burnout among residents and fellows remains a problem. At UVM, a $10,000 annual wellness stipend has helped address some of these issues. Even so, union members at UVM are planning to return to the table within 18 months to continue their collective bargaining.

The ability to access mental health services anywhere you want is also critical for residents, Dr. Walker said.

“If you can only go to a therapist at your own institution, there is a hesitation to utilize that specialist if that’s even offered,” Dr. Walker said. “Do you want to go to therapy with a colleague? Probably not.”

Ultimately, the residents we spoke to are committed to fighting for their workplace rights — no matter how time-consuming or difficult this has been.

“No administration wants us to have to have a union, but it’s necessary,” Dr. Mostoller said. “As an individual, you don’t have leverage to get a seat at the table, but now we have a seat at the table. We have a wonderful contract, but we’re going to keep fighting to make it even better.”

Paving the way for future residents is a key motivator, too.

“There’s this idea of leaving the campsite cleaner than you found it,” Dr. Mostoller told this news organization. “It’s the same thing here — we’re trying to fix this so that the next generation of residents won’t have to.”

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

Several months ago in a letter about healthcare providers and the decision to use alcohol and other mind-altering substances on the job, I waxed enthusiastically about the new wave of no alcohol (NA) and zero (00) alcohol beers that have come on the market. In the last 2 years our local grocery store’s cooler space for nonalcoholic beer has grown from less than 24 inches to something approaching the height of the average sixth grader.

In a bold act of chivalry at the beginning of the pandemic I accepted the mantle of designated grocery shopper and over the last 3 years have become uncommonly proud of my ability to bring home the groceries efficiently and cost effectively, without catching COVID in the process. I have developed a sixth sense of choosing which human checker/bagger combination is fastest or whether the self-checkout is the way to go.

For obvious reasons the human checkers don’t ask for my ID when I am buying adult beverages. However, the self-check register freezes up instantly when I scan my 12-pack of Run Wild nonalcoholic. This necessitates a search for the MIA store person assigned to patrol the self-check corral, ever on the lookout for shoplifters, underage drinkers, and other generally shifty looking characters.

When I find one of the grocery store detectives (who is likely to have been a former patient), I say: “You know, this doesn’t have any alcohol in it.” They invariably reply with a shrug. “I know. But, the rules are the rules.” Occasionally, they may add: “It doesn’t make sense, does it?”

At first blush checking IDs for a nonalcoholic beverage may sound dumb, certainly to someone who is just a few years on either side of the legal drinking age. Why are we trying to protect some crazy teenager from the futility of getting high on a six-pack of something that at worst will make him spend most of the next couple of hours peeing?

But, there is concern in some corners that nonalcoholic drinks pose a significant threat to teenagers. Two PhDs at Stanford University have recently published a paper in which they worry that the dramatic rise in US sales of nonalcoholic drinks from 15% to 30% since 2018 may be socializing “users of alcohol drinking experiences by exposing them to the taste, look, and even brands of alcoholic beverages”.

Is there evidence to support their concern? I could only find one brief report in the Japanese literature that states that among young people “who experienced the nonalcoholic beverage intake, interest in or motivation for drinking alcoholic beverages, and/or smoking is higher than [among] those who did not.” The study didn’t appear to clearly separate the exposure in a family setting from the actual intake.

Beer is an acquired taste. If someone offered you your first taste of beer after a hot-weather set of tennis most of you would reject it and ask for water or lemonade. I can recall my first taste of beer. For some reason my father thought at age 11 or 12 I might like to try some from his glass. I’m not sure of his motivation, but he tried the same thing with oysters. I didn’t drink beer again until I was 16, motivated at that time by a group dynamic. The oyster trial, however, backfired on him and from then on he had to share his coveted dozen with me. Alcohol, unless heavily disguised by a mixer, is also not a taste that most young people find appealing.

It is unlikely that the average thrill-seeking teenager is going to ask his older-appearing buddy with a fake ID to buy him some nonalcoholic beer. Nor would he go to the effort or risk of acquiring his own fake ID just to see how it tastes. It just doesn’t compute, especially to a self-check corral patroller.

I guess one could envision a scenario in which a teenager wanting to fit in with the fast crowd would ask a trusted adult (or clueless parent) to buy him some nonalcoholic beer to bring to a party. He is running a serious risk of being laughed at by his friends if they find he’s drinking the fake stuff. It also seems unlikely that a parent would buy nonalcoholic beer to introduce his teenager to the taste of beer.

So, if there is little evidence to make us consider nonalcoholic beer as a gateway drug, should we continue to prohibit its sale to minors?

Although it runs counter to my usual commitment to evidence-based decisions, making it difficult for adolescents to buy nonalcoholic beverages feels like the right think to do. As long as alcoholic and nonalcoholic beverages share the same display space and are packaged in nearly identical containers, there is ample opportunity for confusion. Recent evidence suggesting that even small amounts of alcohol increases some health risks should strengthen our resolve to minimize that confusion.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Several months ago in a letter about healthcare providers and the decision to use alcohol and other mind-altering substances on the job, I waxed enthusiastically about the new wave of no alcohol (NA) and zero (00) alcohol beers that have come on the market. In the last 2 years our local grocery store’s cooler space for nonalcoholic beer has grown from less than 24 inches to something approaching the height of the average sixth grader.

In a bold act of chivalry at the beginning of the pandemic I accepted the mantle of designated grocery shopper and over the last 3 years have become uncommonly proud of my ability to bring home the groceries efficiently and cost effectively, without catching COVID in the process. I have developed a sixth sense of choosing which human checker/bagger combination is fastest or whether the self-checkout is the way to go.

For obvious reasons the human checkers don’t ask for my ID when I am buying adult beverages. However, the self-check register freezes up instantly when I scan my 12-pack of Run Wild nonalcoholic. This necessitates a search for the MIA store person assigned to patrol the self-check corral, ever on the lookout for shoplifters, underage drinkers, and other generally shifty looking characters.

When I find one of the grocery store detectives (who is likely to have been a former patient), I say: “You know, this doesn’t have any alcohol in it.” They invariably reply with a shrug. “I know. But, the rules are the rules.” Occasionally, they may add: “It doesn’t make sense, does it?”

At first blush checking IDs for a nonalcoholic beverage may sound dumb, certainly to someone who is just a few years on either side of the legal drinking age. Why are we trying to protect some crazy teenager from the futility of getting high on a six-pack of something that at worst will make him spend most of the next couple of hours peeing?

But, there is concern in some corners that nonalcoholic drinks pose a significant threat to teenagers. Two PhDs at Stanford University have recently published a paper in which they worry that the dramatic rise in US sales of nonalcoholic drinks from 15% to 30% since 2018 may be socializing “users of alcohol drinking experiences by exposing them to the taste, look, and even brands of alcoholic beverages”.

Is there evidence to support their concern? I could only find one brief report in the Japanese literature that states that among young people “who experienced the nonalcoholic beverage intake, interest in or motivation for drinking alcoholic beverages, and/or smoking is higher than [among] those who did not.” The study didn’t appear to clearly separate the exposure in a family setting from the actual intake.

Beer is an acquired taste. If someone offered you your first taste of beer after a hot-weather set of tennis most of you would reject it and ask for water or lemonade. I can recall my first taste of beer. For some reason my father thought at age 11 or 12 I might like to try some from his glass. I’m not sure of his motivation, but he tried the same thing with oysters. I didn’t drink beer again until I was 16, motivated at that time by a group dynamic. The oyster trial, however, backfired on him and from then on he had to share his coveted dozen with me. Alcohol, unless heavily disguised by a mixer, is also not a taste that most young people find appealing.

It is unlikely that the average thrill-seeking teenager is going to ask his older-appearing buddy with a fake ID to buy him some nonalcoholic beer. Nor would he go to the effort or risk of acquiring his own fake ID just to see how it tastes. It just doesn’t compute, especially to a self-check corral patroller.

I guess one could envision a scenario in which a teenager wanting to fit in with the fast crowd would ask a trusted adult (or clueless parent) to buy him some nonalcoholic beer to bring to a party. He is running a serious risk of being laughed at by his friends if they find he’s drinking the fake stuff. It also seems unlikely that a parent would buy nonalcoholic beer to introduce his teenager to the taste of beer.

So, if there is little evidence to make us consider nonalcoholic beer as a gateway drug, should we continue to prohibit its sale to minors?

Although it runs counter to my usual commitment to evidence-based decisions, making it difficult for adolescents to buy nonalcoholic beverages feels like the right think to do. As long as alcoholic and nonalcoholic beverages share the same display space and are packaged in nearly identical containers, there is ample opportunity for confusion. Recent evidence suggesting that even small amounts of alcohol increases some health risks should strengthen our resolve to minimize that confusion.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Several months ago in a letter about healthcare providers and the decision to use alcohol and other mind-altering substances on the job, I waxed enthusiastically about the new wave of no alcohol (NA) and zero (00) alcohol beers that have come on the market. In the last 2 years our local grocery store’s cooler space for nonalcoholic beer has grown from less than 24 inches to something approaching the height of the average sixth grader.

In a bold act of chivalry at the beginning of the pandemic I accepted the mantle of designated grocery shopper and over the last 3 years have become uncommonly proud of my ability to bring home the groceries efficiently and cost effectively, without catching COVID in the process. I have developed a sixth sense of choosing which human checker/bagger combination is fastest or whether the self-checkout is the way to go.

For obvious reasons the human checkers don’t ask for my ID when I am buying adult beverages. However, the self-check register freezes up instantly when I scan my 12-pack of Run Wild nonalcoholic. This necessitates a search for the MIA store person assigned to patrol the self-check corral, ever on the lookout for shoplifters, underage drinkers, and other generally shifty looking characters.

When I find one of the grocery store detectives (who is likely to have been a former patient), I say: “You know, this doesn’t have any alcohol in it.” They invariably reply with a shrug. “I know. But, the rules are the rules.” Occasionally, they may add: “It doesn’t make sense, does it?”

At first blush checking IDs for a nonalcoholic beverage may sound dumb, certainly to someone who is just a few years on either side of the legal drinking age. Why are we trying to protect some crazy teenager from the futility of getting high on a six-pack of something that at worst will make him spend most of the next couple of hours peeing?

But, there is concern in some corners that nonalcoholic drinks pose a significant threat to teenagers. Two PhDs at Stanford University have recently published a paper in which they worry that the dramatic rise in US sales of nonalcoholic drinks from 15% to 30% since 2018 may be socializing “users of alcohol drinking experiences by exposing them to the taste, look, and even brands of alcoholic beverages”.

Is there evidence to support their concern? I could only find one brief report in the Japanese literature that states that among young people “who experienced the nonalcoholic beverage intake, interest in or motivation for drinking alcoholic beverages, and/or smoking is higher than [among] those who did not.” The study didn’t appear to clearly separate the exposure in a family setting from the actual intake.

Beer is an acquired taste. If someone offered you your first taste of beer after a hot-weather set of tennis most of you would reject it and ask for water or lemonade. I can recall my first taste of beer. For some reason my father thought at age 11 or 12 I might like to try some from his glass. I’m not sure of his motivation, but he tried the same thing with oysters. I didn’t drink beer again until I was 16, motivated at that time by a group dynamic. The oyster trial, however, backfired on him and from then on he had to share his coveted dozen with me. Alcohol, unless heavily disguised by a mixer, is also not a taste that most young people find appealing.

It is unlikely that the average thrill-seeking teenager is going to ask his older-appearing buddy with a fake ID to buy him some nonalcoholic beer. Nor would he go to the effort or risk of acquiring his own fake ID just to see how it tastes. It just doesn’t compute, especially to a self-check corral patroller.

I guess one could envision a scenario in which a teenager wanting to fit in with the fast crowd would ask a trusted adult (or clueless parent) to buy him some nonalcoholic beer to bring to a party. He is running a serious risk of being laughed at by his friends if they find he’s drinking the fake stuff. It also seems unlikely that a parent would buy nonalcoholic beer to introduce his teenager to the taste of beer.

So, if there is little evidence to make us consider nonalcoholic beer as a gateway drug, should we continue to prohibit its sale to minors?

Although it runs counter to my usual commitment to evidence-based decisions, making it difficult for adolescents to buy nonalcoholic beverages feels like the right think to do. As long as alcoholic and nonalcoholic beverages share the same display space and are packaged in nearly identical containers, there is ample opportunity for confusion. Recent evidence suggesting that even small amounts of alcohol increases some health risks should strengthen our resolve to minimize that confusion.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Acute otitis media (AOM) is caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Since the introduction of pneumococcal conjugate vaccines (PCVs) shifts in the proportion of these three bacteria as causes of AOM and their antibiotic susceptibility profiles and strain diversity have occurred due to multiple factors including the PCVs and antibiotic selection pressure.

The 7-valent PCV (PCV7) was introduced in 2000 and was proven to be efficacious in preventing AOM, but no subsequent PCV has received an indication for prevention of AOM because the FDA required a tympanocentesis study to prove efficacy and that approval was not achieved for PCV13, PCV15, or PCV20. This is a little known fact. After introduction of PCV7, replacement pneumococcal strains expressing serotypes not in PCV7 emerged and antibiotic non-susceptible strains became predominant causes of AOM, especially antibiotic-resistant serotype 19A. To address the phenomena of pneumococcal serotype replacement, PCV13 was introduced in 2010. But serotype replacement continued to occur under PCV13 pressure, replacement serotypes increasingly caused AOM, and antibiotic-resistant serotype 35B emerged. Now we have two new higher valency PCVs: PCV15 (Merck) where serotypes 22F and 33F were added to the PCV13 serotypes and PCV20 (Pfizer) where 22F, 33F, 8, 10A, 11A, 12F, 15B were added to PCV13. Note that neither PCV15 nor PCV20 includes the most common serotype causing AOM – serotype 35B.¹

While PCV15 and PCV20 should provide protection against more pneumococcal serotypes, increasing serotypes in both vaccines decreased immunogenicity of certain shared serotypes, more so with the addition of seven more in PCV20 than two more in PCV15, compared with PCV13. Whether lower antibody concentrations will make a difference clinically in terms of vaccine failure to prevent nasopharyngeal colonization, AOM, and/or invasive pneumococcal infections is currently unknown.

Our group from greater Rochester, New York, is the only one in the United States performing tympanocentesis to determine the etiology of AOM infections. Children between ages 6 and 36 months are studied. We recently reported our results for the time span September 2021 to September 2023, the immediate 2 years prior to recommendations for use of PCV15 and PCV20 in young children.² Tympanocentesis was performed in 139 (78%) of 179 episodes of AOM, yielding 216 middle ear fluid samples (the higher number of middle ear fluids was due to bilateral tympanocentesis in some children). H. influenzae (40%) was the most common bacterial isolate, followed by S. pneumonia (19%) and M. catarrhalis (17%), with the remainder no growth. Polymerase chain reactions (PCR) was positive in many of those culture negative samples, suggesting prior use of antibiotics before tympanocentesis was performed. Among the pneumococcal isolates, 46% were oxacillin non-susceptible. Among the H. influenzae isolates, 27% were beta-lactamase producing and all M. catarrhalis were beta-lactamase-producing.

As we previously reported,¹ we once again found that serotype 35B was the most frequent non-PCV15, non-PCV20, serotype. Other frequently detected non-PCV20 pneumococcal serotypes were 23A, 23B, 35D, 35F and 15C.²
 

Projected Pneumococcal Serotype Coverage by PCV15 and PCV20

PCV13 serotypes were identified in 9% of middle ear fluids, consistent with vaccine failure. As we commence use of PCV15 and PCV20 in the United States, our data provide insights regarding estimation of the projected effects of these vaccines on AOM. Assuming 100% vaccine-type effectiveness, PCV15 will provide about 11% coverage of pneumococci causing AOM, the same PCV13 and PCV20 will provide 30% coverage, leaving 70% of pneumococci causing AOM in young children uncovered (Figure).

MDedge News

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital. He has no conflicts of interest to declare.

References

1. Kaur R et al. Dynamic Changes in Otopathogens Colonizing the Nasopharynx and Causing Acute Otitis Media in Children After 13-Valent (PCV13) Pneumococcal Conjugate Vaccination During 2015-2019. Eur J Clin Microbiol Infect Dis. 2022 Jan;41(1):37-44. doi: 10.1007/s10096-021-04324-0.

2. Kaur R et al. Anticipated Effects of Higher-valency Pneumococcal Conjugate Vaccines on Colonization and Acute Otitis Media. Pediatr Infect Dis J. 2024 Oct 1;43(10):1004-1010. doi: 10.1097/INF.0000000000004413.

3. King LM et al. Pediatric Outpatient Visits and Antibiotic Use Attributable to Higher Valency Pneumococcal Conjugate Vaccine Serotypes. medRxiv [Preprint]. 2023 Aug 25:2023.08.24.23294570. doi: 10.1101/2023.08.24.23294570.

4. Ahmed S et al. Incremental Health Care Utilization and Costs for Acute Otitis Media in Children. Laryngoscope. 2014 Jan;124(1):301-5. doi: 10.1002/lary.24190.

5. Pichichero ME et al. Pathogens Causing Recurrent and Difficult-to-Treat Acute Otitis Media, 2003-2006. Clin Pediatr (Phila). 2008 Nov;47(9):901-6. doi: 10.1177/0009922808319966.

Acute otitis media (AOM) is caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Since the introduction of pneumococcal conjugate vaccines (PCVs) shifts in the proportion of these three bacteria as causes of AOM and their antibiotic susceptibility profiles and strain diversity have occurred due to multiple factors including the PCVs and antibiotic selection pressure.

The 7-valent PCV (PCV7) was introduced in 2000 and was proven to be efficacious in preventing AOM, but no subsequent PCV has received an indication for prevention of AOM because the FDA required a tympanocentesis study to prove efficacy and that approval was not achieved for PCV13, PCV15, or PCV20. This is a little known fact. After introduction of PCV7, replacement pneumococcal strains expressing serotypes not in PCV7 emerged and antibiotic non-susceptible strains became predominant causes of AOM, especially antibiotic-resistant serotype 19A. To address the phenomena of pneumococcal serotype replacement, PCV13 was introduced in 2010. But serotype replacement continued to occur under PCV13 pressure, replacement serotypes increasingly caused AOM, and antibiotic-resistant serotype 35B emerged. Now we have two new higher valency PCVs: PCV15 (Merck) where serotypes 22F and 33F were added to the PCV13 serotypes and PCV20 (Pfizer) where 22F, 33F, 8, 10A, 11A, 12F, 15B were added to PCV13. Note that neither PCV15 nor PCV20 includes the most common serotype causing AOM – serotype 35B.¹

While PCV15 and PCV20 should provide protection against more pneumococcal serotypes, increasing serotypes in both vaccines decreased immunogenicity of certain shared serotypes, more so with the addition of seven more in PCV20 than two more in PCV15, compared with PCV13. Whether lower antibody concentrations will make a difference clinically in terms of vaccine failure to prevent nasopharyngeal colonization, AOM, and/or invasive pneumococcal infections is currently unknown.

Our group from greater Rochester, New York, is the only one in the United States performing tympanocentesis to determine the etiology of AOM infections. Children between ages 6 and 36 months are studied. We recently reported our results for the time span September 2021 to September 2023, the immediate 2 years prior to recommendations for use of PCV15 and PCV20 in young children.² Tympanocentesis was performed in 139 (78%) of 179 episodes of AOM, yielding 216 middle ear fluid samples (the higher number of middle ear fluids was due to bilateral tympanocentesis in some children). H. influenzae (40%) was the most common bacterial isolate, followed by S. pneumonia (19%) and M. catarrhalis (17%), with the remainder no growth. Polymerase chain reactions (PCR) was positive in many of those culture negative samples, suggesting prior use of antibiotics before tympanocentesis was performed. Among the pneumococcal isolates, 46% were oxacillin non-susceptible. Among the H. influenzae isolates, 27% were beta-lactamase producing and all M. catarrhalis were beta-lactamase-producing.

As we previously reported,¹ we once again found that serotype 35B was the most frequent non-PCV15, non-PCV20, serotype. Other frequently detected non-PCV20 pneumococcal serotypes were 23A, 23B, 35D, 35F and 15C.²
 

Projected Pneumococcal Serotype Coverage by PCV15 and PCV20

PCV13 serotypes were identified in 9% of middle ear fluids, consistent with vaccine failure. As we commence use of PCV15 and PCV20 in the United States, our data provide insights regarding estimation of the projected effects of these vaccines on AOM. Assuming 100% vaccine-type effectiveness, PCV15 will provide about 11% coverage of pneumococci causing AOM, the same PCV13 and PCV20 will provide 30% coverage, leaving 70% of pneumococci causing AOM in young children uncovered (Figure).

MDedge News

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital. He has no conflicts of interest to declare.

References

1. Kaur R et al. Dynamic Changes in Otopathogens Colonizing the Nasopharynx and Causing Acute Otitis Media in Children After 13-Valent (PCV13) Pneumococcal Conjugate Vaccination During 2015-2019. Eur J Clin Microbiol Infect Dis. 2022 Jan;41(1):37-44. doi: 10.1007/s10096-021-04324-0.

2. Kaur R et al. Anticipated Effects of Higher-valency Pneumococcal Conjugate Vaccines on Colonization and Acute Otitis Media. Pediatr Infect Dis J. 2024 Oct 1;43(10):1004-1010. doi: 10.1097/INF.0000000000004413.

3. King LM et al. Pediatric Outpatient Visits and Antibiotic Use Attributable to Higher Valency Pneumococcal Conjugate Vaccine Serotypes. medRxiv [Preprint]. 2023 Aug 25:2023.08.24.23294570. doi: 10.1101/2023.08.24.23294570.

4. Ahmed S et al. Incremental Health Care Utilization and Costs for Acute Otitis Media in Children. Laryngoscope. 2014 Jan;124(1):301-5. doi: 10.1002/lary.24190.

5. Pichichero ME et al. Pathogens Causing Recurrent and Difficult-to-Treat Acute Otitis Media, 2003-2006. Clin Pediatr (Phila). 2008 Nov;47(9):901-6. doi: 10.1177/0009922808319966.

Acute otitis media (AOM) is caused by Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Since the introduction of pneumococcal conjugate vaccines (PCVs) shifts in the proportion of these three bacteria as causes of AOM and their antibiotic susceptibility profiles and strain diversity have occurred due to multiple factors including the PCVs and antibiotic selection pressure.

The 7-valent PCV (PCV7) was introduced in 2000 and was proven to be efficacious in preventing AOM, but no subsequent PCV has received an indication for prevention of AOM because the FDA required a tympanocentesis study to prove efficacy and that approval was not achieved for PCV13, PCV15, or PCV20. This is a little known fact. After introduction of PCV7, replacement pneumococcal strains expressing serotypes not in PCV7 emerged and antibiotic non-susceptible strains became predominant causes of AOM, especially antibiotic-resistant serotype 19A. To address the phenomena of pneumococcal serotype replacement, PCV13 was introduced in 2010. But serotype replacement continued to occur under PCV13 pressure, replacement serotypes increasingly caused AOM, and antibiotic-resistant serotype 35B emerged. Now we have two new higher valency PCVs: PCV15 (Merck) where serotypes 22F and 33F were added to the PCV13 serotypes and PCV20 (Pfizer) where 22F, 33F, 8, 10A, 11A, 12F, 15B were added to PCV13. Note that neither PCV15 nor PCV20 includes the most common serotype causing AOM – serotype 35B.¹

While PCV15 and PCV20 should provide protection against more pneumococcal serotypes, increasing serotypes in both vaccines decreased immunogenicity of certain shared serotypes, more so with the addition of seven more in PCV20 than two more in PCV15, compared with PCV13. Whether lower antibody concentrations will make a difference clinically in terms of vaccine failure to prevent nasopharyngeal colonization, AOM, and/or invasive pneumococcal infections is currently unknown.

Our group from greater Rochester, New York, is the only one in the United States performing tympanocentesis to determine the etiology of AOM infections. Children between ages 6 and 36 months are studied. We recently reported our results for the time span September 2021 to September 2023, the immediate 2 years prior to recommendations for use of PCV15 and PCV20 in young children.² Tympanocentesis was performed in 139 (78%) of 179 episodes of AOM, yielding 216 middle ear fluid samples (the higher number of middle ear fluids was due to bilateral tympanocentesis in some children). H. influenzae (40%) was the most common bacterial isolate, followed by S. pneumonia (19%) and M. catarrhalis (17%), with the remainder no growth. Polymerase chain reactions (PCR) was positive in many of those culture negative samples, suggesting prior use of antibiotics before tympanocentesis was performed. Among the pneumococcal isolates, 46% were oxacillin non-susceptible. Among the H. influenzae isolates, 27% were beta-lactamase producing and all M. catarrhalis were beta-lactamase-producing.

As we previously reported,¹ we once again found that serotype 35B was the most frequent non-PCV15, non-PCV20, serotype. Other frequently detected non-PCV20 pneumococcal serotypes were 23A, 23B, 35D, 35F and 15C.²
 

Projected Pneumococcal Serotype Coverage by PCV15 and PCV20

PCV13 serotypes were identified in 9% of middle ear fluids, consistent with vaccine failure. As we commence use of PCV15 and PCV20 in the United States, our data provide insights regarding estimation of the projected effects of these vaccines on AOM. Assuming 100% vaccine-type effectiveness, PCV15 will provide about 11% coverage of pneumococci causing AOM, the same PCV13 and PCV20 will provide 30% coverage, leaving 70% of pneumococci causing AOM in young children uncovered (Figure).

MDedge News

Dr. Pichichero is a specialist in pediatric infectious diseases, Center for Infectious Diseases and Immunology, and director of the Research Institute, at Rochester (N.Y.) General Hospital. He has no conflicts of interest to declare.

References

1. Kaur R et al. Dynamic Changes in Otopathogens Colonizing the Nasopharynx and Causing Acute Otitis Media in Children After 13-Valent (PCV13) Pneumococcal Conjugate Vaccination During 2015-2019. Eur J Clin Microbiol Infect Dis. 2022 Jan;41(1):37-44. doi: 10.1007/s10096-021-04324-0.

2. Kaur R et al. Anticipated Effects of Higher-valency Pneumococcal Conjugate Vaccines on Colonization and Acute Otitis Media. Pediatr Infect Dis J. 2024 Oct 1;43(10):1004-1010. doi: 10.1097/INF.0000000000004413.

3. King LM et al. Pediatric Outpatient Visits and Antibiotic Use Attributable to Higher Valency Pneumococcal Conjugate Vaccine Serotypes. medRxiv [Preprint]. 2023 Aug 25:2023.08.24.23294570. doi: 10.1101/2023.08.24.23294570.

4. Ahmed S et al. Incremental Health Care Utilization and Costs for Acute Otitis Media in Children. Laryngoscope. 2014 Jan;124(1):301-5. doi: 10.1002/lary.24190.

5. Pichichero ME et al. Pathogens Causing Recurrent and Difficult-to-Treat Acute Otitis Media, 2003-2006. Clin Pediatr (Phila). 2008 Nov;47(9):901-6. doi: 10.1177/0009922808319966.

The rate of congenital heart defects is higher in newborns conceived using assisted reproductive technologies (ART) than in newborns conceived without assistance. This finding comes from a population-based cohort study led by Dr. Nona Sargisian, a gynecologist at the University of Gothenburg, Sweden, and colleagues, which was published in the European Heart Journal.

The researchers analyzed more than 7 million results of all live-born children in Denmark, Finland, Sweden, and Norway between 1984 and 2015. They found that congenital heart defects occurred more frequently in the ART newborn group (1.85%) than in naturally conceived newborns (1.15%).

The study also revealed that the risk for congenital heart defects in multiple births is higher than in single births, with and without the use of ART. However, the result that congenital heart defects occur more often in ART newborns remained significant when comparing single births from both groups (1.62% vs 1.11%).
 

Relatively Low Prevalence

Barbara Sonntag, MD, PhD, a gynecologist at Amedes Fertility Center in Hamburg, Germany, referred to a “clinically relevant risk increase” with a relatively low prevalence of the condition.

“When 1000 children are born, an abnormality occurs in 18 children after ART, compared with 11 children born after natural conception,” she told the Science Media Center.

Dr. Sonntag emphasized that the risk is particularly increased by a multiple pregnancy. A statement about causality is not possible based on the study, but multiple pregnancies are generally associated with increased risks during pregnancy and for the children.

The large and robust dataset confirms long-known findings, said Georg Griesinger, MD, PhD, medical director of the fertility centers of the University Medical Center Schleswig-Holstein in Lübeck and Manhagen, Germany.

The key figures can be found in single births, he explained. “Among single births conceived by ART, the rate of severe congenital heart defects was 1.62% compared with 1.11% in spontaneously conceived single births, an increase in risk by 1.19 times. For severe heart defects, the rate was 0.31% in ART single births, compared with 0.25% in spontaneously conceived single births.”

The increased risks are consistent with existing literature. Therefore, the current study does not reveal any new risk signals, said Dr. Griesinger.
 

Single Embryo Transfer

The “risks are small but present,” according to Michael von Wolff, MD, head of gynecological endocrinology and reproductive medicine at Bern University Hospital in Switzerland. “Therefore, ART therapy should only be carried out after exhausting conservative treatments,” he recommended. For example, ovarian stimulation with low-dose hormone preparations could be an option.

Dr. Griesinger pointed out that, in absolute numbers, all maternal and fetal or neonatal risks are significantly increased in twins and higher-order multiples, compared with the estimated risk association within the actual ART treatment.

“For this reason, reproductive medicine specialists have been advocating for single-embryo transfer for years to promote the occurrence of single pregnancies through ART,” said Dr. Griesinger.

The study “emphasizes the importance of single embryo transfer to avoid the higher risks associated with multiple pregnancies,” according to Rocío Núñez Calonge, PhD, scientific director of the International Reproduction Unit in Alicante, Spain.

Dr. Sonntag also sees a “strong additional call to avoid multiple pregnancies through a predominant strategy of single-embryo transfer in the data. The increased rate of childhood birth defects is already part of the information provided before assisted reproduction.”

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The rate of congenital heart defects is higher in newborns conceived using assisted reproductive technologies (ART) than in newborns conceived without assistance. This finding comes from a population-based cohort study led by Dr. Nona Sargisian, a gynecologist at the University of Gothenburg, Sweden, and colleagues, which was published in the European Heart Journal.

The researchers analyzed more than 7 million results of all live-born children in Denmark, Finland, Sweden, and Norway between 1984 and 2015. They found that congenital heart defects occurred more frequently in the ART newborn group (1.85%) than in naturally conceived newborns (1.15%).

The study also revealed that the risk for congenital heart defects in multiple births is higher than in single births, with and without the use of ART. However, the result that congenital heart defects occur more often in ART newborns remained significant when comparing single births from both groups (1.62% vs 1.11%).
 

Relatively Low Prevalence

Barbara Sonntag, MD, PhD, a gynecologist at Amedes Fertility Center in Hamburg, Germany, referred to a “clinically relevant risk increase” with a relatively low prevalence of the condition.

“When 1000 children are born, an abnormality occurs in 18 children after ART, compared with 11 children born after natural conception,” she told the Science Media Center.

Dr. Sonntag emphasized that the risk is particularly increased by a multiple pregnancy. A statement about causality is not possible based on the study, but multiple pregnancies are generally associated with increased risks during pregnancy and for the children.

The large and robust dataset confirms long-known findings, said Georg Griesinger, MD, PhD, medical director of the fertility centers of the University Medical Center Schleswig-Holstein in Lübeck and Manhagen, Germany.

The key figures can be found in single births, he explained. “Among single births conceived by ART, the rate of severe congenital heart defects was 1.62% compared with 1.11% in spontaneously conceived single births, an increase in risk by 1.19 times. For severe heart defects, the rate was 0.31% in ART single births, compared with 0.25% in spontaneously conceived single births.”

The increased risks are consistent with existing literature. Therefore, the current study does not reveal any new risk signals, said Dr. Griesinger.
 

Single Embryo Transfer

The “risks are small but present,” according to Michael von Wolff, MD, head of gynecological endocrinology and reproductive medicine at Bern University Hospital in Switzerland. “Therefore, ART therapy should only be carried out after exhausting conservative treatments,” he recommended. For example, ovarian stimulation with low-dose hormone preparations could be an option.

Dr. Griesinger pointed out that, in absolute numbers, all maternal and fetal or neonatal risks are significantly increased in twins and higher-order multiples, compared with the estimated risk association within the actual ART treatment.

“For this reason, reproductive medicine specialists have been advocating for single-embryo transfer for years to promote the occurrence of single pregnancies through ART,” said Dr. Griesinger.

The study “emphasizes the importance of single embryo transfer to avoid the higher risks associated with multiple pregnancies,” according to Rocío Núñez Calonge, PhD, scientific director of the International Reproduction Unit in Alicante, Spain.

Dr. Sonntag also sees a “strong additional call to avoid multiple pregnancies through a predominant strategy of single-embryo transfer in the data. The increased rate of childhood birth defects is already part of the information provided before assisted reproduction.”

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

The rate of congenital heart defects is higher in newborns conceived using assisted reproductive technologies (ART) than in newborns conceived without assistance. This finding comes from a population-based cohort study led by Dr. Nona Sargisian, a gynecologist at the University of Gothenburg, Sweden, and colleagues, which was published in the European Heart Journal.

The researchers analyzed more than 7 million results of all live-born children in Denmark, Finland, Sweden, and Norway between 1984 and 2015. They found that congenital heart defects occurred more frequently in the ART newborn group (1.85%) than in naturally conceived newborns (1.15%).

The study also revealed that the risk for congenital heart defects in multiple births is higher than in single births, with and without the use of ART. However, the result that congenital heart defects occur more often in ART newborns remained significant when comparing single births from both groups (1.62% vs 1.11%).
 

Relatively Low Prevalence

Barbara Sonntag, MD, PhD, a gynecologist at Amedes Fertility Center in Hamburg, Germany, referred to a “clinically relevant risk increase” with a relatively low prevalence of the condition.

“When 1000 children are born, an abnormality occurs in 18 children after ART, compared with 11 children born after natural conception,” she told the Science Media Center.

Dr. Sonntag emphasized that the risk is particularly increased by a multiple pregnancy. A statement about causality is not possible based on the study, but multiple pregnancies are generally associated with increased risks during pregnancy and for the children.

The large and robust dataset confirms long-known findings, said Georg Griesinger, MD, PhD, medical director of the fertility centers of the University Medical Center Schleswig-Holstein in Lübeck and Manhagen, Germany.

The key figures can be found in single births, he explained. “Among single births conceived by ART, the rate of severe congenital heart defects was 1.62% compared with 1.11% in spontaneously conceived single births, an increase in risk by 1.19 times. For severe heart defects, the rate was 0.31% in ART single births, compared with 0.25% in spontaneously conceived single births.”

The increased risks are consistent with existing literature. Therefore, the current study does not reveal any new risk signals, said Dr. Griesinger.
 

Single Embryo Transfer

The “risks are small but present,” according to Michael von Wolff, MD, head of gynecological endocrinology and reproductive medicine at Bern University Hospital in Switzerland. “Therefore, ART therapy should only be carried out after exhausting conservative treatments,” he recommended. For example, ovarian stimulation with low-dose hormone preparations could be an option.

Dr. Griesinger pointed out that, in absolute numbers, all maternal and fetal or neonatal risks are significantly increased in twins and higher-order multiples, compared with the estimated risk association within the actual ART treatment.

“For this reason, reproductive medicine specialists have been advocating for single-embryo transfer for years to promote the occurrence of single pregnancies through ART,” said Dr. Griesinger.

The study “emphasizes the importance of single embryo transfer to avoid the higher risks associated with multiple pregnancies,” according to Rocío Núñez Calonge, PhD, scientific director of the International Reproduction Unit in Alicante, Spain.

Dr. Sonntag also sees a “strong additional call to avoid multiple pregnancies through a predominant strategy of single-embryo transfer in the data. The increased rate of childhood birth defects is already part of the information provided before assisted reproduction.”

This story was translated from the Medscape German edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.