Pediatrics

You have a 16-year-old patient who has been doing poorly in school. He has withdrawn from his social group and quit the sports in which he excelled. He admits to using marijuana “maybe once or twice a week.” But you and his parents suspect that it is much more often and contributing to the change in his behavior and school performance.

They would prefer he not use marijuana at all but could maybe be comfortable with some arrangement in which their son could demonstrate that his usage was indeed limited to once or twice on the weekends. They ask for your help with crafting a contract that might include “some urine or blood test” that would allow them to be sure their son was adhering to the contract.

You explain to them that there are hazards associated with setting up contracts such as the one they are proposing. One revolving around the issue of trust. Another being that he may be addicted to the point that a compromise that includes scaling back his usage is unlikely to succeed. And, finally, you tell them that because of marijuana’s pharmacokinetics, their son’s urine tests will always be positive and not reflective of the how much he is using or whether he is intoxicated.

Scenarios similar to this are increasingly common for those of us living in states that have legalized recreational cannabis use. The absence of a laboratory test that can determine when a person is impaired by marijuana has made life difficult for law enforcement officers accustomed to relying on breath and blood tests for alcohol to confirm their suspicion that a driver is under the influence.

In addition, because marijuana is still detectable days after it is used, many well-paying jobs go unfilled when potential applicants are hesitant to submit to a required drug test. The quirky pharmacokinetics of cannabis are well-known to the recreational users and they see no reason to risk failing a urine test regardless of how good the job may be.

This lack of a reliable indicator of cannabis intoxication has not gone unnoticed, and in a recent study published in the journal Neuropharmacology, researchers at Massachusetts General Hospital in Boston report some hopeful results using fNIRS brain scanning. The investigators observed an increase in the level of oxygenated hemoglobin concentration (HbO), which is a type of neural activity signature, in the prefrontal cortex region of the volunteers who reported being impaired.

While a brain scan may sound like an unwieldy tool to use on roadside sobriety stops, the researchers report that portable scanners – some using skull cap sensors – could be easily adapted for use by law enforcement in the field. This technology also could be used by employers on the job site to test truck drivers and heavy machine operators at the beginning of each shift, thereby allaying the fears of responsible cannabis users.

This technology might be helpful to you in advising the parents of the 16-year-old you suspect of heavy usage. It would certainly help in confirming the suspicion that he is using more often than he claims. However, the contract the parents propose still may not work. If this young man demonstrates on multiple attempts that his word can’t be trusted, technology isn’t going to be the answer.

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 pdnews@mdedge.com.

You have a 16-year-old patient who has been doing poorly in school. He has withdrawn from his social group and quit the sports in which he excelled. He admits to using marijuana “maybe once or twice a week.” But you and his parents suspect that it is much more often and contributing to the change in his behavior and school performance.

They would prefer he not use marijuana at all but could maybe be comfortable with some arrangement in which their son could demonstrate that his usage was indeed limited to once or twice on the weekends. They ask for your help with crafting a contract that might include “some urine or blood test” that would allow them to be sure their son was adhering to the contract.

You explain to them that there are hazards associated with setting up contracts such as the one they are proposing. One revolving around the issue of trust. Another being that he may be addicted to the point that a compromise that includes scaling back his usage is unlikely to succeed. And, finally, you tell them that because of marijuana’s pharmacokinetics, their son’s urine tests will always be positive and not reflective of the how much he is using or whether he is intoxicated.

Scenarios similar to this are increasingly common for those of us living in states that have legalized recreational cannabis use. The absence of a laboratory test that can determine when a person is impaired by marijuana has made life difficult for law enforcement officers accustomed to relying on breath and blood tests for alcohol to confirm their suspicion that a driver is under the influence.

In addition, because marijuana is still detectable days after it is used, many well-paying jobs go unfilled when potential applicants are hesitant to submit to a required drug test. The quirky pharmacokinetics of cannabis are well-known to the recreational users and they see no reason to risk failing a urine test regardless of how good the job may be.

This lack of a reliable indicator of cannabis intoxication has not gone unnoticed, and in a recent study published in the journal Neuropharmacology, researchers at Massachusetts General Hospital in Boston report some hopeful results using fNIRS brain scanning. The investigators observed an increase in the level of oxygenated hemoglobin concentration (HbO), which is a type of neural activity signature, in the prefrontal cortex region of the volunteers who reported being impaired.

While a brain scan may sound like an unwieldy tool to use on roadside sobriety stops, the researchers report that portable scanners – some using skull cap sensors – could be easily adapted for use by law enforcement in the field. This technology also could be used by employers on the job site to test truck drivers and heavy machine operators at the beginning of each shift, thereby allaying the fears of responsible cannabis users.

This technology might be helpful to you in advising the parents of the 16-year-old you suspect of heavy usage. It would certainly help in confirming the suspicion that he is using more often than he claims. However, the contract the parents propose still may not work. If this young man demonstrates on multiple attempts that his word can’t be trusted, technology isn’t going to be the answer.

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 pdnews@mdedge.com.

You have a 16-year-old patient who has been doing poorly in school. He has withdrawn from his social group and quit the sports in which he excelled. He admits to using marijuana “maybe once or twice a week.” But you and his parents suspect that it is much more often and contributing to the change in his behavior and school performance.

They would prefer he not use marijuana at all but could maybe be comfortable with some arrangement in which their son could demonstrate that his usage was indeed limited to once or twice on the weekends. They ask for your help with crafting a contract that might include “some urine or blood test” that would allow them to be sure their son was adhering to the contract.

You explain to them that there are hazards associated with setting up contracts such as the one they are proposing. One revolving around the issue of trust. Another being that he may be addicted to the point that a compromise that includes scaling back his usage is unlikely to succeed. And, finally, you tell them that because of marijuana’s pharmacokinetics, their son’s urine tests will always be positive and not reflective of the how much he is using or whether he is intoxicated.

Scenarios similar to this are increasingly common for those of us living in states that have legalized recreational cannabis use. The absence of a laboratory test that can determine when a person is impaired by marijuana has made life difficult for law enforcement officers accustomed to relying on breath and blood tests for alcohol to confirm their suspicion that a driver is under the influence.

In addition, because marijuana is still detectable days after it is used, many well-paying jobs go unfilled when potential applicants are hesitant to submit to a required drug test. The quirky pharmacokinetics of cannabis are well-known to the recreational users and they see no reason to risk failing a urine test regardless of how good the job may be.

This lack of a reliable indicator of cannabis intoxication has not gone unnoticed, and in a recent study published in the journal Neuropharmacology, researchers at Massachusetts General Hospital in Boston report some hopeful results using fNIRS brain scanning. The investigators observed an increase in the level of oxygenated hemoglobin concentration (HbO), which is a type of neural activity signature, in the prefrontal cortex region of the volunteers who reported being impaired.

While a brain scan may sound like an unwieldy tool to use on roadside sobriety stops, the researchers report that portable scanners – some using skull cap sensors – could be easily adapted for use by law enforcement in the field. This technology also could be used by employers on the job site to test truck drivers and heavy machine operators at the beginning of each shift, thereby allaying the fears of responsible cannabis users.

This technology might be helpful to you in advising the parents of the 16-year-old you suspect of heavy usage. It would certainly help in confirming the suspicion that he is using more often than he claims. However, the contract the parents propose still may not work. If this young man demonstrates on multiple attempts that his word can’t be trusted, technology isn’t going to be the answer.

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 pdnews@mdedge.com.

Boys exposed to at least 2 hours a day of screen time by 1 year of age were significantly more likely to have an autism spectrum disorder (ASD) diagnosis at 3 years, based on data from more than 80,000 children.

The World Health Organization and the American Academy of Pediatrics recommend against any screen time for infants up to 1 year of age and 18 months of age, respectively, wrote Megumi Kushima, MA, of the University of Yamanashi (Japan), and colleagues on behalf of the Japan Environment and Children’s Study Group.

The extent to which screen time duration in infancy is associated with subsequent ASD diagnosis remains unclear, the researchers said. The ongoing COVID-19 pandemic has increased screen time among children worldwide, which makes an examination of the impact of screen time on children’s health an important public health issue.

In a study published in JAMA Pediatrics, the researchers recruited pregnant women between 2011 and 2014; data were analyzed in December 2020. The final study population included 84,030 mother-child pairs. The primary exposure of screen time at 1 year of age was assessed by questionnaire, in which mothers were asked to report their number of hours they let their child watch TV or DVDs daily. Responses were none (no screen time), less than 1 hour, 1 hour or more but less than 2 hours, 2 hours or more but less than 4 hours, and 4 hours or more.

The primary outcome was ASD diagnosis at 3 years of age, and mothers were asked via questionnaire whether their 3-year-old had been diagnosed with ASD from age 2.

The study was conducted by the Japan Environment and Children’s Study Group at 15 regional centers across Japan.

Overall, 330 children had received an ASD diagnosis at age 3 years, a prevalence of 0.4%. Of these, 251 (76%) were boys, and 79 (24%) were girls. Independent of ASD, the most common response for screen time was less than 1 hour, which was reported by 27,707 mothers. The proportion of children with ASD at age 3 increased as screen time at age 1 increased, the percentages were 5.8%, 22.3%, 30.2%, and 31.7% for children with no screen time, less than 1 hour, 1 to less than 2 hours, and 2 to less than 4 hours, respectively. The percentage of children with ASD diagnoses who had 4 hours or more of daily screen time was 10%.

Logistic regression analysis showed that longer screen time at age 1 year was significantly associated with higher odds of ASD at 3 years in boys, but not in girls. The researchers controlled for variables including maternal maltreatment and children’s predisposition to ASD. Among boys, the adjusted odds ratios for screen times of less than 1 hour, 1 hour to less than 2 hours, 2 hours to less than 4 hours, and more than 4 hours were 1.38, 2.16, 3.48, and 3.02, respectively.

Screen time at age 3 years was not associated with ASD diagnosis at age 3 years, potentially “because the association with environmental factors on brain development varies with age,” the researchers noted.

The study findings were limited by several factors including the reliance on parental reports of screen time and potential for reporting bias, the researchers noted. Other limitations included the possible missed diagnoses of mild ASD cases at 3 years, and the inability to consider variables such as childcare environment, living conditions, diseases, genetics, and disabilities.

However, the results were strengthened by the large study population and examination of screen time in early childhood, they said. More research is needed to examine other factors that contribute to the association between ASD and screen time, but given the rapid increase in device use in children, “it is necessary to review its health effects on infants and control excessive screen time.”
 

Strong study, but some gaps appear

The study is strong in many respects, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

However, “what I am not sure they addressed is that children on the spectrum are often not entertained by basic toys and may be hard to manage behaviorally,” Dr. Kinsella said. Consequently, parents may be more inclined to offer screen time as a way to pacify children with behavioral difficulties. “Parents also may see that their children are happier interacting with devices, so they may be more apt to let them continue with screen time.We know screen time is not good for the developing brain, however; I worry that the message from this study is that screen time causes autism in boys.

“What I would have liked to know from the parents who allowed more screen time was why they were offering it,” Dr. Kinsella said. “Was it because their child was difficult behaviorally or because that is the one place that they seemed to have satisfaction? To me, that would indicate the reverse hypothesis.” That said, the study findings “remind us to counsel families about screen time, especially in the age of COVID-19. Kids are home much longer than usual, which ultimately leads to more screen time.”

The study was funded by the Japanese Ministry of Environment. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

Boys exposed to at least 2 hours a day of screen time by 1 year of age were significantly more likely to have an autism spectrum disorder (ASD) diagnosis at 3 years, based on data from more than 80,000 children.

The World Health Organization and the American Academy of Pediatrics recommend against any screen time for infants up to 1 year of age and 18 months of age, respectively, wrote Megumi Kushima, MA, of the University of Yamanashi (Japan), and colleagues on behalf of the Japan Environment and Children’s Study Group.

The extent to which screen time duration in infancy is associated with subsequent ASD diagnosis remains unclear, the researchers said. The ongoing COVID-19 pandemic has increased screen time among children worldwide, which makes an examination of the impact of screen time on children’s health an important public health issue.

In a study published in JAMA Pediatrics, the researchers recruited pregnant women between 2011 and 2014; data were analyzed in December 2020. The final study population included 84,030 mother-child pairs. The primary exposure of screen time at 1 year of age was assessed by questionnaire, in which mothers were asked to report their number of hours they let their child watch TV or DVDs daily. Responses were none (no screen time), less than 1 hour, 1 hour or more but less than 2 hours, 2 hours or more but less than 4 hours, and 4 hours or more.

The primary outcome was ASD diagnosis at 3 years of age, and mothers were asked via questionnaire whether their 3-year-old had been diagnosed with ASD from age 2.

The study was conducted by the Japan Environment and Children’s Study Group at 15 regional centers across Japan.

Overall, 330 children had received an ASD diagnosis at age 3 years, a prevalence of 0.4%. Of these, 251 (76%) were boys, and 79 (24%) were girls. Independent of ASD, the most common response for screen time was less than 1 hour, which was reported by 27,707 mothers. The proportion of children with ASD at age 3 increased as screen time at age 1 increased, the percentages were 5.8%, 22.3%, 30.2%, and 31.7% for children with no screen time, less than 1 hour, 1 to less than 2 hours, and 2 to less than 4 hours, respectively. The percentage of children with ASD diagnoses who had 4 hours or more of daily screen time was 10%.

Logistic regression analysis showed that longer screen time at age 1 year was significantly associated with higher odds of ASD at 3 years in boys, but not in girls. The researchers controlled for variables including maternal maltreatment and children’s predisposition to ASD. Among boys, the adjusted odds ratios for screen times of less than 1 hour, 1 hour to less than 2 hours, 2 hours to less than 4 hours, and more than 4 hours were 1.38, 2.16, 3.48, and 3.02, respectively.

Screen time at age 3 years was not associated with ASD diagnosis at age 3 years, potentially “because the association with environmental factors on brain development varies with age,” the researchers noted.

The study findings were limited by several factors including the reliance on parental reports of screen time and potential for reporting bias, the researchers noted. Other limitations included the possible missed diagnoses of mild ASD cases at 3 years, and the inability to consider variables such as childcare environment, living conditions, diseases, genetics, and disabilities.

However, the results were strengthened by the large study population and examination of screen time in early childhood, they said. More research is needed to examine other factors that contribute to the association between ASD and screen time, but given the rapid increase in device use in children, “it is necessary to review its health effects on infants and control excessive screen time.”
 

Strong study, but some gaps appear

The study is strong in many respects, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

However, “what I am not sure they addressed is that children on the spectrum are often not entertained by basic toys and may be hard to manage behaviorally,” Dr. Kinsella said. Consequently, parents may be more inclined to offer screen time as a way to pacify children with behavioral difficulties. “Parents also may see that their children are happier interacting with devices, so they may be more apt to let them continue with screen time.We know screen time is not good for the developing brain, however; I worry that the message from this study is that screen time causes autism in boys.

“What I would have liked to know from the parents who allowed more screen time was why they were offering it,” Dr. Kinsella said. “Was it because their child was difficult behaviorally or because that is the one place that they seemed to have satisfaction? To me, that would indicate the reverse hypothesis.” That said, the study findings “remind us to counsel families about screen time, especially in the age of COVID-19. Kids are home much longer than usual, which ultimately leads to more screen time.”

The study was funded by the Japanese Ministry of Environment. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

Boys exposed to at least 2 hours a day of screen time by 1 year of age were significantly more likely to have an autism spectrum disorder (ASD) diagnosis at 3 years, based on data from more than 80,000 children.

The World Health Organization and the American Academy of Pediatrics recommend against any screen time for infants up to 1 year of age and 18 months of age, respectively, wrote Megumi Kushima, MA, of the University of Yamanashi (Japan), and colleagues on behalf of the Japan Environment and Children’s Study Group.

The extent to which screen time duration in infancy is associated with subsequent ASD diagnosis remains unclear, the researchers said. The ongoing COVID-19 pandemic has increased screen time among children worldwide, which makes an examination of the impact of screen time on children’s health an important public health issue.

In a study published in JAMA Pediatrics, the researchers recruited pregnant women between 2011 and 2014; data were analyzed in December 2020. The final study population included 84,030 mother-child pairs. The primary exposure of screen time at 1 year of age was assessed by questionnaire, in which mothers were asked to report their number of hours they let their child watch TV or DVDs daily. Responses were none (no screen time), less than 1 hour, 1 hour or more but less than 2 hours, 2 hours or more but less than 4 hours, and 4 hours or more.

The primary outcome was ASD diagnosis at 3 years of age, and mothers were asked via questionnaire whether their 3-year-old had been diagnosed with ASD from age 2.

The study was conducted by the Japan Environment and Children’s Study Group at 15 regional centers across Japan.

Overall, 330 children had received an ASD diagnosis at age 3 years, a prevalence of 0.4%. Of these, 251 (76%) were boys, and 79 (24%) were girls. Independent of ASD, the most common response for screen time was less than 1 hour, which was reported by 27,707 mothers. The proportion of children with ASD at age 3 increased as screen time at age 1 increased, the percentages were 5.8%, 22.3%, 30.2%, and 31.7% for children with no screen time, less than 1 hour, 1 to less than 2 hours, and 2 to less than 4 hours, respectively. The percentage of children with ASD diagnoses who had 4 hours or more of daily screen time was 10%.

Logistic regression analysis showed that longer screen time at age 1 year was significantly associated with higher odds of ASD at 3 years in boys, but not in girls. The researchers controlled for variables including maternal maltreatment and children’s predisposition to ASD. Among boys, the adjusted odds ratios for screen times of less than 1 hour, 1 hour to less than 2 hours, 2 hours to less than 4 hours, and more than 4 hours were 1.38, 2.16, 3.48, and 3.02, respectively.

Screen time at age 3 years was not associated with ASD diagnosis at age 3 years, potentially “because the association with environmental factors on brain development varies with age,” the researchers noted.

The study findings were limited by several factors including the reliance on parental reports of screen time and potential for reporting bias, the researchers noted. Other limitations included the possible missed diagnoses of mild ASD cases at 3 years, and the inability to consider variables such as childcare environment, living conditions, diseases, genetics, and disabilities.

However, the results were strengthened by the large study population and examination of screen time in early childhood, they said. More research is needed to examine other factors that contribute to the association between ASD and screen time, but given the rapid increase in device use in children, “it is necessary to review its health effects on infants and control excessive screen time.”
 

Strong study, but some gaps appear

The study is strong in many respects, Karalyn Kinsella, MD, a pediatrician in private practice in Cheshire, Conn., said in an interview.

However, “what I am not sure they addressed is that children on the spectrum are often not entertained by basic toys and may be hard to manage behaviorally,” Dr. Kinsella said. Consequently, parents may be more inclined to offer screen time as a way to pacify children with behavioral difficulties. “Parents also may see that their children are happier interacting with devices, so they may be more apt to let them continue with screen time.We know screen time is not good for the developing brain, however; I worry that the message from this study is that screen time causes autism in boys.

“What I would have liked to know from the parents who allowed more screen time was why they were offering it,” Dr. Kinsella said. “Was it because their child was difficult behaviorally or because that is the one place that they seemed to have satisfaction? To me, that would indicate the reverse hypothesis.” That said, the study findings “remind us to counsel families about screen time, especially in the age of COVID-19. Kids are home much longer than usual, which ultimately leads to more screen time.”

The study was funded by the Japanese Ministry of Environment. The researchers had no financial conflicts to disclose. Dr. Kinsella had no financial conflicts to disclose, but serves as a member of the Pediatric News editorial advisory board.

The pediatric oncology workforce has faced a host of financial, physical, and psychological obstacles during the COVID-19 pandemic, according to a study that surveyed workers from more than 200 institutions in 79 countries.

A snapshot of the extensive findings reveals that half of participating institutions experienced staffing shortages that had a “major impact” on pediatric cancer care. On the financial front, many respondents pointed to instances of unpaid leave and diminished salary, and others highlighted the psychological toll of providing care, including high rates of burnout and stress. The challenges were evident across high- and low-income countries.

Despite these barriers, pediatric oncology clinicians demonstrated incredible perseverance.

Health care professionals “caring for children with cancer across the world were shown to be incredibly resilient, coming together to continue to provide care even in the direst circumstances,” Elizabeth R. Sniderman, MSN, APRN, of St. Jude Children’s Research Hospital, Memphis, and colleagues concluded.

The findings, published online Jan. 24, 2022, in Cancer, highlight the global impact of COVID-19 on pediatric oncology clinicians early in the pandemic.

The survey, conducted in summer 2020, included responses from 311 pediatric oncology clinicians who completed a 60-item questionnaire about their experiences of clinical care, resources, and support. The investigators also convened 19 multidisciplinary focus groups who answered questions related to teamwork, communication, and changes to care. Respondents practiced in low- to high-income countries, and included pediatric hematologists and oncologists, nurses, and infectious disease physicians.

Overall, the investigators found that just over half of institutions experienced “major” shortages of clinical staff (108 of 213), and two-thirds experienced reductions in staffing availability (141 of 213). Notably, national income was not associated with this reduction; rather, staffing shortages were more likely to occur in countries with greater COVID-19 incidence and mortality rates.

Respondents reported experiencing threats to their physical health, with half pointing to a lack of necessary personal protective equipment. The financial and psychological toll of the pandemic represented another major stressor, with the effects described across all income levels.

One respondent from Belarus commented on financial concerns, noting that “people don’t really want to admit that they don’t feel well ... they know, that if infected, unpaid self-isolation is waiting for them. Either you don’t go to work for 2 weeks, unpaid, or you go to work for 2 weeks, paid, and endanger all of your colleagues with your infection.”

A respondent from Mexico described the psychological stress: “Honestly, I think that sometimes we put aside the mental health of all of us involved, myself included. I think we were all on the verge of collapse ... practically all the residents who were rotating here told us that they had anxiety attacks, panic attacks, they could not sleep, [and] many of them needed psychiatric medicine.”

Others highlighted feelings of guilt about their ability to provide the highest level of care. An oncologist in the United States noted: “This was a major stress for many providers because [we are] feeling unable to provide the same level of care which we used to provide. And this is what eventually takes a toll.”

And despite these pandemic-related challenges, the study authors found that only 46% of institutions (99 of 213) made psychological support available to staff.


 

Rays of hope

But it was not all bad news.

Participants also described a greater sense of teamwork, communication, and collegiality throughout the pandemic – “stabilizing elements,” which helped mitigate the many physical, psychological, and financial stressors.

An infection-control physician in Belarus highlighted the importance of receiving “support and encouragement” from colleagues: “When a person gets tired and they have no more enthusiasm, it’s easy to give up and say: ‘I can’t do this anymore.’ But when you see a colleague who tries ... to share the work, and help each other, then you get extra strength.”

An oncologist in South Africa agreed, noting that “everyone has got their sleeves rolled up and are doing the work ... and that’s a testament to everyone that we work with. There was no one that shied away from work or used this as an excuse to do less work.”

An oncologist in Spain described practicing during the pandemic being “one of the best experiences I have had,” explaining that “I have been working in this hospital for ... 25 years, [and] I have never had the feeling of being so informed at all levels.”

Overall, the findings paint a picture of a resilient workforce, and offer lessons about preparedness for future crises, the investigators concluded.

“To protect pediatric oncology providers and their patients, organizations must pay attention to interventions that increase physical, psychological, and financial safety,” the authors stressed. For instance, providing adequate personal protective equipment and vaccines, allowing for time off and rest, and setting up professional psychology services as well as access to peer-support programs can help protect staff.

Although this survey took place relatively early in the pandemic, organizations should take heed of the findings, Lorena V. Baroni, MD, of Hospital J P Garrahan, Buenos Aires, and Eric Bouffet, MD, of The Hospital for Sick Children, Toronto, wrote in an accompanying editorial.

“The results presented in this study should not be taken lightly,” Dr. Baroni and Dr. Bouffet wrote. “The most concerning findings are the physical and psychological impact experienced by pediatric oncology providers.” And perhaps most surprisingly, “the survey did not identify any difference based on country income groups. Participants in both low- and high-income countries described similar oncologic care limitations.”

Overall, these findings “reflect a serious risk that can ultimately affect the care of children and compromise the success of their treatment,” Dr. Baroni and Dr. Bouffet wrote.

This study was supported by the American Lebanese Syrian Associated Charities. The study authors and editorialists have disclosed no relevant financial relationships.

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

The pediatric oncology workforce has faced a host of financial, physical, and psychological obstacles during the COVID-19 pandemic, according to a study that surveyed workers from more than 200 institutions in 79 countries.

A snapshot of the extensive findings reveals that half of participating institutions experienced staffing shortages that had a “major impact” on pediatric cancer care. On the financial front, many respondents pointed to instances of unpaid leave and diminished salary, and others highlighted the psychological toll of providing care, including high rates of burnout and stress. The challenges were evident across high- and low-income countries.

Despite these barriers, pediatric oncology clinicians demonstrated incredible perseverance.

Health care professionals “caring for children with cancer across the world were shown to be incredibly resilient, coming together to continue to provide care even in the direst circumstances,” Elizabeth R. Sniderman, MSN, APRN, of St. Jude Children’s Research Hospital, Memphis, and colleagues concluded.

The findings, published online Jan. 24, 2022, in Cancer, highlight the global impact of COVID-19 on pediatric oncology clinicians early in the pandemic.

The survey, conducted in summer 2020, included responses from 311 pediatric oncology clinicians who completed a 60-item questionnaire about their experiences of clinical care, resources, and support. The investigators also convened 19 multidisciplinary focus groups who answered questions related to teamwork, communication, and changes to care. Respondents practiced in low- to high-income countries, and included pediatric hematologists and oncologists, nurses, and infectious disease physicians.

Overall, the investigators found that just over half of institutions experienced “major” shortages of clinical staff (108 of 213), and two-thirds experienced reductions in staffing availability (141 of 213). Notably, national income was not associated with this reduction; rather, staffing shortages were more likely to occur in countries with greater COVID-19 incidence and mortality rates.

Respondents reported experiencing threats to their physical health, with half pointing to a lack of necessary personal protective equipment. The financial and psychological toll of the pandemic represented another major stressor, with the effects described across all income levels.

One respondent from Belarus commented on financial concerns, noting that “people don’t really want to admit that they don’t feel well ... they know, that if infected, unpaid self-isolation is waiting for them. Either you don’t go to work for 2 weeks, unpaid, or you go to work for 2 weeks, paid, and endanger all of your colleagues with your infection.”

A respondent from Mexico described the psychological stress: “Honestly, I think that sometimes we put aside the mental health of all of us involved, myself included. I think we were all on the verge of collapse ... practically all the residents who were rotating here told us that they had anxiety attacks, panic attacks, they could not sleep, [and] many of them needed psychiatric medicine.”

Others highlighted feelings of guilt about their ability to provide the highest level of care. An oncologist in the United States noted: “This was a major stress for many providers because [we are] feeling unable to provide the same level of care which we used to provide. And this is what eventually takes a toll.”

And despite these pandemic-related challenges, the study authors found that only 46% of institutions (99 of 213) made psychological support available to staff.


 

Rays of hope

But it was not all bad news.

Participants also described a greater sense of teamwork, communication, and collegiality throughout the pandemic – “stabilizing elements,” which helped mitigate the many physical, psychological, and financial stressors.

An infection-control physician in Belarus highlighted the importance of receiving “support and encouragement” from colleagues: “When a person gets tired and they have no more enthusiasm, it’s easy to give up and say: ‘I can’t do this anymore.’ But when you see a colleague who tries ... to share the work, and help each other, then you get extra strength.”

An oncologist in South Africa agreed, noting that “everyone has got their sleeves rolled up and are doing the work ... and that’s a testament to everyone that we work with. There was no one that shied away from work or used this as an excuse to do less work.”

An oncologist in Spain described practicing during the pandemic being “one of the best experiences I have had,” explaining that “I have been working in this hospital for ... 25 years, [and] I have never had the feeling of being so informed at all levels.”

Overall, the findings paint a picture of a resilient workforce, and offer lessons about preparedness for future crises, the investigators concluded.

“To protect pediatric oncology providers and their patients, organizations must pay attention to interventions that increase physical, psychological, and financial safety,” the authors stressed. For instance, providing adequate personal protective equipment and vaccines, allowing for time off and rest, and setting up professional psychology services as well as access to peer-support programs can help protect staff.

Although this survey took place relatively early in the pandemic, organizations should take heed of the findings, Lorena V. Baroni, MD, of Hospital J P Garrahan, Buenos Aires, and Eric Bouffet, MD, of The Hospital for Sick Children, Toronto, wrote in an accompanying editorial.

“The results presented in this study should not be taken lightly,” Dr. Baroni and Dr. Bouffet wrote. “The most concerning findings are the physical and psychological impact experienced by pediatric oncology providers.” And perhaps most surprisingly, “the survey did not identify any difference based on country income groups. Participants in both low- and high-income countries described similar oncologic care limitations.”

Overall, these findings “reflect a serious risk that can ultimately affect the care of children and compromise the success of their treatment,” Dr. Baroni and Dr. Bouffet wrote.

This study was supported by the American Lebanese Syrian Associated Charities. The study authors and editorialists have disclosed no relevant financial relationships.

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

The pediatric oncology workforce has faced a host of financial, physical, and psychological obstacles during the COVID-19 pandemic, according to a study that surveyed workers from more than 200 institutions in 79 countries.

A snapshot of the extensive findings reveals that half of participating institutions experienced staffing shortages that had a “major impact” on pediatric cancer care. On the financial front, many respondents pointed to instances of unpaid leave and diminished salary, and others highlighted the psychological toll of providing care, including high rates of burnout and stress. The challenges were evident across high- and low-income countries.

Despite these barriers, pediatric oncology clinicians demonstrated incredible perseverance.

Health care professionals “caring for children with cancer across the world were shown to be incredibly resilient, coming together to continue to provide care even in the direst circumstances,” Elizabeth R. Sniderman, MSN, APRN, of St. Jude Children’s Research Hospital, Memphis, and colleagues concluded.

The findings, published online Jan. 24, 2022, in Cancer, highlight the global impact of COVID-19 on pediatric oncology clinicians early in the pandemic.

The survey, conducted in summer 2020, included responses from 311 pediatric oncology clinicians who completed a 60-item questionnaire about their experiences of clinical care, resources, and support. The investigators also convened 19 multidisciplinary focus groups who answered questions related to teamwork, communication, and changes to care. Respondents practiced in low- to high-income countries, and included pediatric hematologists and oncologists, nurses, and infectious disease physicians.

Overall, the investigators found that just over half of institutions experienced “major” shortages of clinical staff (108 of 213), and two-thirds experienced reductions in staffing availability (141 of 213). Notably, national income was not associated with this reduction; rather, staffing shortages were more likely to occur in countries with greater COVID-19 incidence and mortality rates.

Respondents reported experiencing threats to their physical health, with half pointing to a lack of necessary personal protective equipment. The financial and psychological toll of the pandemic represented another major stressor, with the effects described across all income levels.

One respondent from Belarus commented on financial concerns, noting that “people don’t really want to admit that they don’t feel well ... they know, that if infected, unpaid self-isolation is waiting for them. Either you don’t go to work for 2 weeks, unpaid, or you go to work for 2 weeks, paid, and endanger all of your colleagues with your infection.”

A respondent from Mexico described the psychological stress: “Honestly, I think that sometimes we put aside the mental health of all of us involved, myself included. I think we were all on the verge of collapse ... practically all the residents who were rotating here told us that they had anxiety attacks, panic attacks, they could not sleep, [and] many of them needed psychiatric medicine.”

Others highlighted feelings of guilt about their ability to provide the highest level of care. An oncologist in the United States noted: “This was a major stress for many providers because [we are] feeling unable to provide the same level of care which we used to provide. And this is what eventually takes a toll.”

And despite these pandemic-related challenges, the study authors found that only 46% of institutions (99 of 213) made psychological support available to staff.


 

Rays of hope

But it was not all bad news.

Participants also described a greater sense of teamwork, communication, and collegiality throughout the pandemic – “stabilizing elements,” which helped mitigate the many physical, psychological, and financial stressors.

An infection-control physician in Belarus highlighted the importance of receiving “support and encouragement” from colleagues: “When a person gets tired and they have no more enthusiasm, it’s easy to give up and say: ‘I can’t do this anymore.’ But when you see a colleague who tries ... to share the work, and help each other, then you get extra strength.”

An oncologist in South Africa agreed, noting that “everyone has got their sleeves rolled up and are doing the work ... and that’s a testament to everyone that we work with. There was no one that shied away from work or used this as an excuse to do less work.”

An oncologist in Spain described practicing during the pandemic being “one of the best experiences I have had,” explaining that “I have been working in this hospital for ... 25 years, [and] I have never had the feeling of being so informed at all levels.”

Overall, the findings paint a picture of a resilient workforce, and offer lessons about preparedness for future crises, the investigators concluded.

“To protect pediatric oncology providers and their patients, organizations must pay attention to interventions that increase physical, psychological, and financial safety,” the authors stressed. For instance, providing adequate personal protective equipment and vaccines, allowing for time off and rest, and setting up professional psychology services as well as access to peer-support programs can help protect staff.

Although this survey took place relatively early in the pandemic, organizations should take heed of the findings, Lorena V. Baroni, MD, of Hospital J P Garrahan, Buenos Aires, and Eric Bouffet, MD, of The Hospital for Sick Children, Toronto, wrote in an accompanying editorial.

“The results presented in this study should not be taken lightly,” Dr. Baroni and Dr. Bouffet wrote. “The most concerning findings are the physical and psychological impact experienced by pediatric oncology providers.” And perhaps most surprisingly, “the survey did not identify any difference based on country income groups. Participants in both low- and high-income countries described similar oncologic care limitations.”

Overall, these findings “reflect a serious risk that can ultimately affect the care of children and compromise the success of their treatment,” Dr. Baroni and Dr. Bouffet wrote.

This study was supported by the American Lebanese Syrian Associated Charities. The study authors and editorialists have disclosed no relevant financial relationships.

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

Many factors influence a child’s subsequent susceptibility to respiratory tract infection (RTI), including breastfeeding, crowded conditions, and exposure to environmental tobacco. Now researchers have found that asymptomatic viral infection in the first days of a baby’s life are linked to a greater risk of respiratory infections in later life.

The new research, published in Nature Microbiology, was conducted as part of the Microbiome Utrecht Infant Study (MUIS), a healthy infant birth cohort study that’s been running for 6 years.

In their study, the authors explained how the respiratory tract is “populated by a specialized microbial ecosystem, which is seeded during and directly following birth,” adding that, “despite recognition of many host and environmental factors known to modulate RTI susceptibility, the mechanism by which a child develops recurrent or severe RTIs, while others remain healthy, remains largely unknown”.

Researchers from the University of Edinburgh and University Medical Centre Utrecht (the Netherlands) examined nasal mucosa samples of 114 babies at various times from birth until 12 months of age. They then analyzed the gene activity of the babies’ nasal mucosa, the microbes present in the lining of the nose, and any viruses that infected the children.
 

Interferon-related mucosal gene activity

The researchers described how the microbiome – the community of microbes in the body – of a newborn baby can be influenced by many things, including delivery method, breastfeeding, antibiotics and the hospital environment. They highlighted how viruses were found to interact with a newborn’s immune system and microbiome in a way that affected both a child’s risk, and number, of subsequent infections.

They explained how when a viral infection was detected in the first days after birth, which they said largely occurred asymptomatically, specific mucosal genes were activated – genes involved with interferons – coinciding with a change in the composition of the microbiome, promoting the growth of potentially harmful microbes.

“The interferon-related gene activity caused by an early first viral infection is thought to create a proinflammatory environment that makes babies susceptible to future infections,” they said, adding that in their study they have demonstrated that “first asymptomatic viral encounters were associated with increased interferon signaling, and preceded the development of disadvantageous respiratory microbiota profiles and clinical RTIs”.
 

Proinflammatory and microbiologically perturbed environment

Debby Bogaert, PhD, chair of paediatric medicine at the University of Edinburgh, said: “We were surprised to see viral infections occur so early in life, and go mostly unnoticed, probably because the infant’s immune system is in what is known as a state of tolerance after birth. Despite this, these infections seem to affect a normal immune development, which is important to know.”

The authors wrote that their data supports the hypothesis that first viral encounters trigger an interferon-associated proinflammatory environment, which then further drives airway inflammation and symptomatology in a “self-enforcing positive feedback loop”. They said that this “proinflammatory and microbiologically perturbed environment in turn renders an individual more vulnerable to recurrent viral-induced RTIs”.

Wouter de Steenhuijsen, PhD, postdoctoral investigator at University Medical Centre Utrecht, said: “Although further work will be needed to confirm the causality of our findings, the data from this study indicate that early-life encounters with respiratory viruses – especially during the first days of life – may set the tone for subsequent non-beneficial host-microbe interactions, which are related to an infection risk and possibly long term respiratory health.”

Dr. Bogaert added: “Only from birth onwards will an infant start to develop its microbiome. Limiting the number of viral encounters in those first days to weeks of life might be essential for a healthy immune and microbiome development, and consequently long term respiratory health.”

A version of this article first appeared on Medscape UK.

Many factors influence a child’s subsequent susceptibility to respiratory tract infection (RTI), including breastfeeding, crowded conditions, and exposure to environmental tobacco. Now researchers have found that asymptomatic viral infection in the first days of a baby’s life are linked to a greater risk of respiratory infections in later life.

The new research, published in Nature Microbiology, was conducted as part of the Microbiome Utrecht Infant Study (MUIS), a healthy infant birth cohort study that’s been running for 6 years.

In their study, the authors explained how the respiratory tract is “populated by a specialized microbial ecosystem, which is seeded during and directly following birth,” adding that, “despite recognition of many host and environmental factors known to modulate RTI susceptibility, the mechanism by which a child develops recurrent or severe RTIs, while others remain healthy, remains largely unknown”.

Researchers from the University of Edinburgh and University Medical Centre Utrecht (the Netherlands) examined nasal mucosa samples of 114 babies at various times from birth until 12 months of age. They then analyzed the gene activity of the babies’ nasal mucosa, the microbes present in the lining of the nose, and any viruses that infected the children.
 

Interferon-related mucosal gene activity

The researchers described how the microbiome – the community of microbes in the body – of a newborn baby can be influenced by many things, including delivery method, breastfeeding, antibiotics and the hospital environment. They highlighted how viruses were found to interact with a newborn’s immune system and microbiome in a way that affected both a child’s risk, and number, of subsequent infections.

They explained how when a viral infection was detected in the first days after birth, which they said largely occurred asymptomatically, specific mucosal genes were activated – genes involved with interferons – coinciding with a change in the composition of the microbiome, promoting the growth of potentially harmful microbes.

“The interferon-related gene activity caused by an early first viral infection is thought to create a proinflammatory environment that makes babies susceptible to future infections,” they said, adding that in their study they have demonstrated that “first asymptomatic viral encounters were associated with increased interferon signaling, and preceded the development of disadvantageous respiratory microbiota profiles and clinical RTIs”.
 

Proinflammatory and microbiologically perturbed environment

Debby Bogaert, PhD, chair of paediatric medicine at the University of Edinburgh, said: “We were surprised to see viral infections occur so early in life, and go mostly unnoticed, probably because the infant’s immune system is in what is known as a state of tolerance after birth. Despite this, these infections seem to affect a normal immune development, which is important to know.”

The authors wrote that their data supports the hypothesis that first viral encounters trigger an interferon-associated proinflammatory environment, which then further drives airway inflammation and symptomatology in a “self-enforcing positive feedback loop”. They said that this “proinflammatory and microbiologically perturbed environment in turn renders an individual more vulnerable to recurrent viral-induced RTIs”.

Wouter de Steenhuijsen, PhD, postdoctoral investigator at University Medical Centre Utrecht, said: “Although further work will be needed to confirm the causality of our findings, the data from this study indicate that early-life encounters with respiratory viruses – especially during the first days of life – may set the tone for subsequent non-beneficial host-microbe interactions, which are related to an infection risk and possibly long term respiratory health.”

Dr. Bogaert added: “Only from birth onwards will an infant start to develop its microbiome. Limiting the number of viral encounters in those first days to weeks of life might be essential for a healthy immune and microbiome development, and consequently long term respiratory health.”

A version of this article first appeared on Medscape UK.

Many factors influence a child’s subsequent susceptibility to respiratory tract infection (RTI), including breastfeeding, crowded conditions, and exposure to environmental tobacco. Now researchers have found that asymptomatic viral infection in the first days of a baby’s life are linked to a greater risk of respiratory infections in later life.

The new research, published in Nature Microbiology, was conducted as part of the Microbiome Utrecht Infant Study (MUIS), a healthy infant birth cohort study that’s been running for 6 years.

In their study, the authors explained how the respiratory tract is “populated by a specialized microbial ecosystem, which is seeded during and directly following birth,” adding that, “despite recognition of many host and environmental factors known to modulate RTI susceptibility, the mechanism by which a child develops recurrent or severe RTIs, while others remain healthy, remains largely unknown”.

Researchers from the University of Edinburgh and University Medical Centre Utrecht (the Netherlands) examined nasal mucosa samples of 114 babies at various times from birth until 12 months of age. They then analyzed the gene activity of the babies’ nasal mucosa, the microbes present in the lining of the nose, and any viruses that infected the children.
 

Interferon-related mucosal gene activity

The researchers described how the microbiome – the community of microbes in the body – of a newborn baby can be influenced by many things, including delivery method, breastfeeding, antibiotics and the hospital environment. They highlighted how viruses were found to interact with a newborn’s immune system and microbiome in a way that affected both a child’s risk, and number, of subsequent infections.

They explained how when a viral infection was detected in the first days after birth, which they said largely occurred asymptomatically, specific mucosal genes were activated – genes involved with interferons – coinciding with a change in the composition of the microbiome, promoting the growth of potentially harmful microbes.

“The interferon-related gene activity caused by an early first viral infection is thought to create a proinflammatory environment that makes babies susceptible to future infections,” they said, adding that in their study they have demonstrated that “first asymptomatic viral encounters were associated with increased interferon signaling, and preceded the development of disadvantageous respiratory microbiota profiles and clinical RTIs”.
 

Proinflammatory and microbiologically perturbed environment

Debby Bogaert, PhD, chair of paediatric medicine at the University of Edinburgh, said: “We were surprised to see viral infections occur so early in life, and go mostly unnoticed, probably because the infant’s immune system is in what is known as a state of tolerance after birth. Despite this, these infections seem to affect a normal immune development, which is important to know.”

The authors wrote that their data supports the hypothesis that first viral encounters trigger an interferon-associated proinflammatory environment, which then further drives airway inflammation and symptomatology in a “self-enforcing positive feedback loop”. They said that this “proinflammatory and microbiologically perturbed environment in turn renders an individual more vulnerable to recurrent viral-induced RTIs”.

Wouter de Steenhuijsen, PhD, postdoctoral investigator at University Medical Centre Utrecht, said: “Although further work will be needed to confirm the causality of our findings, the data from this study indicate that early-life encounters with respiratory viruses – especially during the first days of life – may set the tone for subsequent non-beneficial host-microbe interactions, which are related to an infection risk and possibly long term respiratory health.”

Dr. Bogaert added: “Only from birth onwards will an infant start to develop its microbiome. Limiting the number of viral encounters in those first days to weeks of life might be essential for a healthy immune and microbiome development, and consequently long term respiratory health.”

A version of this article first appeared on Medscape UK.

A spoonful of sugar helps the medicine go down – but what if the sugar is the medicine?

Nearly three in four children with irritable bowel syndrome (IBS) or unexplained abdominal pain reported at least a 30% improvement in discomfort after taking a regimen of sugar water they knew had no medicinal properties.

The findings, published online in JAMA Pediatrics on Jan. 31, 2022, also revealed that participants used significantly less rescue medications when taking the so-called “open-label placebo.” The magnitude of the effect was enough to meet one of the criteria from the Food and Drug Administration to approve drugs to treat IBS, which affects between 10% and 15% of U.S. children.

Although open-label placebo is not ready for clinical use, IBS expert Miranda van Tilburg, PhD, said she is “glad we have evidence” of a strong response in this patient population and that the results “may make clinicians rethink how they introduce treatments.

“By emphasizing their belief that a treatment may work, clinicians can harness the placebo effect,” Dr. van Tilburg, professor of medicine and vice chair of research at Marshall University, Huntington, W.Va., told this news organization.

Study leader Samuel Nurko, MD, MPH, the director of the functional abdominal pain program at Harvard Medical School, Boston, said placebo-controlled trials in patients with IBS and functional abdominal pain consistently show a “very high placebo response.” The question his group set out to answer, he said, was: “Can we get the pain symptoms of these children better by giving them placebo with no deception?”

Between 2015 and 2018, Dr. Nurko and colleagues randomly assigned 30 children and adolescents, aged 8-18 years, with IBS or functional abdominal pain to receive either an open-label inert liquid placebo – consisting of 85% sucrose, citric acid, purified water, and the preservative methyl paraben – twice daily for 3 weeks followed by 3 weeks with no placebo, or to follow the reverse sequence. Roughly half (53%) of the children had functional abdominal pain, and 47% had IBS as defined by Rome III criteria.

Researchers at the three participating clinical sites followed a standardized protocol for explaining the nature of placebo (“like sugar pills without medication”), telling participants that adults with conditions like theirs often benefit from placebo when they receive it as part of blinded, randomized clinical trials. Participants in the study were allowed to use hyoscyamine, an anticholinergic medication, as rescue treatment during the trial.

Dr. Nurko’s team reported that patients had a mean pain score of 39.9 on a 100-point visual analogue scale during the open-label placebo phase of the trial and a mean score of 45 during the control period. That difference was statistically significant (P = .03).

Participants took an average of two hyoscyamine pills during the placebo phase, compared with 3.8 pills during the 3-week period when they did not receive placebo (P < .001).

Nearly three-fourths (73.3%) of children in the study reported that open-label placebo improved their pain by over 30%, thus meeting one of the FDA’s criteria for clinical evaluation of drugs for IBS. Half said the placebo liquid cut their pain by more than 50%.

Dr. Nurko said the findings highlight the need to address “mind-body connections” in the management of gut-brain disorders. Like Dr. van Tilburg, he cautioned that open-label placebo “is not ready for widespread use. Placebo is complicated, and we need to understand the mechanism” underlying its efficacy.

“The idea is eventually we will be able to sort out the exact mechanism and harness it for clinical practice,” he added.

However, Dr. van Tilburg expressed that using placebo therapy to treat children and adolescents with these conditions could send the message that “the pain is not real or all in their heads. Children with chronic pain encounter a lot of stigma, and this kind of treatment may increase the feeling of not being believed. We should be careful to avoid this.”

The study was funded by the National Institutes of Health, the Swiss National Science Foundation, the Schwartz family fund, the Foundation for the Science of the Therapeutic Relationship, and the Morgan Family Foundation.

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

A spoonful of sugar helps the medicine go down – but what if the sugar is the medicine?

Nearly three in four children with irritable bowel syndrome (IBS) or unexplained abdominal pain reported at least a 30% improvement in discomfort after taking a regimen of sugar water they knew had no medicinal properties.

The findings, published online in JAMA Pediatrics on Jan. 31, 2022, also revealed that participants used significantly less rescue medications when taking the so-called “open-label placebo.” The magnitude of the effect was enough to meet one of the criteria from the Food and Drug Administration to approve drugs to treat IBS, which affects between 10% and 15% of U.S. children.

Although open-label placebo is not ready for clinical use, IBS expert Miranda van Tilburg, PhD, said she is “glad we have evidence” of a strong response in this patient population and that the results “may make clinicians rethink how they introduce treatments.

“By emphasizing their belief that a treatment may work, clinicians can harness the placebo effect,” Dr. van Tilburg, professor of medicine and vice chair of research at Marshall University, Huntington, W.Va., told this news organization.

Study leader Samuel Nurko, MD, MPH, the director of the functional abdominal pain program at Harvard Medical School, Boston, said placebo-controlled trials in patients with IBS and functional abdominal pain consistently show a “very high placebo response.” The question his group set out to answer, he said, was: “Can we get the pain symptoms of these children better by giving them placebo with no deception?”

Between 2015 and 2018, Dr. Nurko and colleagues randomly assigned 30 children and adolescents, aged 8-18 years, with IBS or functional abdominal pain to receive either an open-label inert liquid placebo – consisting of 85% sucrose, citric acid, purified water, and the preservative methyl paraben – twice daily for 3 weeks followed by 3 weeks with no placebo, or to follow the reverse sequence. Roughly half (53%) of the children had functional abdominal pain, and 47% had IBS as defined by Rome III criteria.

Researchers at the three participating clinical sites followed a standardized protocol for explaining the nature of placebo (“like sugar pills without medication”), telling participants that adults with conditions like theirs often benefit from placebo when they receive it as part of blinded, randomized clinical trials. Participants in the study were allowed to use hyoscyamine, an anticholinergic medication, as rescue treatment during the trial.

Dr. Nurko’s team reported that patients had a mean pain score of 39.9 on a 100-point visual analogue scale during the open-label placebo phase of the trial and a mean score of 45 during the control period. That difference was statistically significant (P = .03).

Participants took an average of two hyoscyamine pills during the placebo phase, compared with 3.8 pills during the 3-week period when they did not receive placebo (P < .001).

Nearly three-fourths (73.3%) of children in the study reported that open-label placebo improved their pain by over 30%, thus meeting one of the FDA’s criteria for clinical evaluation of drugs for IBS. Half said the placebo liquid cut their pain by more than 50%.

Dr. Nurko said the findings highlight the need to address “mind-body connections” in the management of gut-brain disorders. Like Dr. van Tilburg, he cautioned that open-label placebo “is not ready for widespread use. Placebo is complicated, and we need to understand the mechanism” underlying its efficacy.

“The idea is eventually we will be able to sort out the exact mechanism and harness it for clinical practice,” he added.

However, Dr. van Tilburg expressed that using placebo therapy to treat children and adolescents with these conditions could send the message that “the pain is not real or all in their heads. Children with chronic pain encounter a lot of stigma, and this kind of treatment may increase the feeling of not being believed. We should be careful to avoid this.”

The study was funded by the National Institutes of Health, the Swiss National Science Foundation, the Schwartz family fund, the Foundation for the Science of the Therapeutic Relationship, and the Morgan Family Foundation.

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

A spoonful of sugar helps the medicine go down – but what if the sugar is the medicine?

Nearly three in four children with irritable bowel syndrome (IBS) or unexplained abdominal pain reported at least a 30% improvement in discomfort after taking a regimen of sugar water they knew had no medicinal properties.

The findings, published online in JAMA Pediatrics on Jan. 31, 2022, also revealed that participants used significantly less rescue medications when taking the so-called “open-label placebo.” The magnitude of the effect was enough to meet one of the criteria from the Food and Drug Administration to approve drugs to treat IBS, which affects between 10% and 15% of U.S. children.

Although open-label placebo is not ready for clinical use, IBS expert Miranda van Tilburg, PhD, said she is “glad we have evidence” of a strong response in this patient population and that the results “may make clinicians rethink how they introduce treatments.

“By emphasizing their belief that a treatment may work, clinicians can harness the placebo effect,” Dr. van Tilburg, professor of medicine and vice chair of research at Marshall University, Huntington, W.Va., told this news organization.

Study leader Samuel Nurko, MD, MPH, the director of the functional abdominal pain program at Harvard Medical School, Boston, said placebo-controlled trials in patients with IBS and functional abdominal pain consistently show a “very high placebo response.” The question his group set out to answer, he said, was: “Can we get the pain symptoms of these children better by giving them placebo with no deception?”

Between 2015 and 2018, Dr. Nurko and colleagues randomly assigned 30 children and adolescents, aged 8-18 years, with IBS or functional abdominal pain to receive either an open-label inert liquid placebo – consisting of 85% sucrose, citric acid, purified water, and the preservative methyl paraben – twice daily for 3 weeks followed by 3 weeks with no placebo, or to follow the reverse sequence. Roughly half (53%) of the children had functional abdominal pain, and 47% had IBS as defined by Rome III criteria.

Researchers at the three participating clinical sites followed a standardized protocol for explaining the nature of placebo (“like sugar pills without medication”), telling participants that adults with conditions like theirs often benefit from placebo when they receive it as part of blinded, randomized clinical trials. Participants in the study were allowed to use hyoscyamine, an anticholinergic medication, as rescue treatment during the trial.

Dr. Nurko’s team reported that patients had a mean pain score of 39.9 on a 100-point visual analogue scale during the open-label placebo phase of the trial and a mean score of 45 during the control period. That difference was statistically significant (P = .03).

Participants took an average of two hyoscyamine pills during the placebo phase, compared with 3.8 pills during the 3-week period when they did not receive placebo (P < .001).

Nearly three-fourths (73.3%) of children in the study reported that open-label placebo improved their pain by over 30%, thus meeting one of the FDA’s criteria for clinical evaluation of drugs for IBS. Half said the placebo liquid cut their pain by more than 50%.

Dr. Nurko said the findings highlight the need to address “mind-body connections” in the management of gut-brain disorders. Like Dr. van Tilburg, he cautioned that open-label placebo “is not ready for widespread use. Placebo is complicated, and we need to understand the mechanism” underlying its efficacy.

“The idea is eventually we will be able to sort out the exact mechanism and harness it for clinical practice,” he added.

However, Dr. van Tilburg expressed that using placebo therapy to treat children and adolescents with these conditions could send the message that “the pain is not real or all in their heads. Children with chronic pain encounter a lot of stigma, and this kind of treatment may increase the feeling of not being believed. We should be careful to avoid this.”

The study was funded by the National Institutes of Health, the Swiss National Science Foundation, the Schwartz family fund, the Foundation for the Science of the Therapeutic Relationship, and the Morgan Family Foundation.

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

COVID-19 vaccine hesitancy may be associated with traumatic events in childhood that undermine trust, including domestic violence, substance abuse in the home, or neglect, data published Feb. 1 suggest.

The findings by Mark A. Bellis, DSc, College of Human Sciences, Bangor (Wales) University, and colleagues were published online in BMJ Open.

The results are especially significant, the authors say, because of the prevalence of adverse childhood experiences (ACEs) globally, with proportions of people having multiple traumas in some countries at 10% or more of the population.

The authors wrote that hesitancy or refusal to get the vaccine increased with the number of traumas reported.

For example, hesitancy was three times higher among people who had experienced four or more types of childhood trauma than among those who did not report any traumatic events.

Dr. Bellis told this news organization that though their work suggests that higher levels of ACEs are linked with higher vaccine hesitancy, it is by no means the only reason people choose not to get vaccinated.

However, he said, the association they found may have key messages for clinicians.

“For clinicians, simply being trauma informed can help,” Dr. Bellis said. “Understanding how such childhood adversity can affect people may help them when discussing vaccines, and in understanding resistance to what is a complex medical issue and one that requires considerable trust. What can appear routine to a clinician may be a difficult leap of faith especially for those who have poorer experiences of trusting even within family settings.”
 

More trauma, less trust

The authors used responses to a nationally representative telephone survey of adults in Wales taken between December 2020 and March 2021, when COVID-19 restrictions were in force. Out of 6,763 people contacted, 2,285 met all criteria and answered all the questions and were included in the final analysis.

The survey asked about nine types of ACEs before the age of 18, including: parental separation; physical, verbal, and sexual abuse; exposure to domestic violence; and living with a household member who has mental illness, misuses alcohol and/or drugs, or who was incarcerated.

It also included personal details and long-term health information.

About half of the respondents said they hadn’t experienced any childhood trauma. Of those who did, one in five said they had experienced one type, 17% reported two to three types, and 10% reported four or more.

According to the authors, prevalence of ACEs reported was consistent with other comparable population surveys, including those conducted face to face.

They also investigated measures of trust and preference for different health regulations.

People with more ACEs were more likely to have low trust in National Health Service COVID-19 information.

“Other sociodemographics and a history of either chronic disease or COVID-19 infection were not significantly associated with low trust,” the authors pointed out.

People reporting higher ACEs also were more likely to report that they felt they were unfairly restricted by the government. People with four or more ACEs were twice as likely than were those with no ACEs to say they felt unfairly restricted and wanted rules such as mandatory masking to stop.

People with four or more types of trauma were almost twice as likely to ignore the restrictions as were those who hadn’t experienced any – 38% versus 21% – to ignore the restrictions, even after the researchers accounted for associations with sociodemographic factors and previous COVID-19 infection or a history of long-term conditions. 

“Clinicians can be a powerful voice to counter more alarmist or even conspiratorial messages that might otherwise resonate with those who find trust difficult,” Dr. Bellis said.

He said that the effect of childhood adversity needs to be considered at all levels in health systems. Overarching public health strategists should include ways to earn trust to counter resistance in some of the most vulnerable communities where ACEs can be higher.

It will also be important in the short-term to “provide reassurance, build community champions, and understand the low base from which trust needs to be built,” he said.
 

Loss of control

“Past traumatic experiences can predispose someone to avoid things that remind them of that trauma. This avoidance protects them from re-experiencing the negative symptoms and behaviors that come with it. Whether this results into hesitancy of something that would benefit their health is not well known,” Consuelo Cagande, MD, senior associate program director and fellowship adviser in the department of child and adolescent psychiatry and behavioral sciences, Children’s Hospital of Philadelphia, told this news organization.

She pointed out a limitation the authors mention that is common when using ACEs as a measure linking to future negative behaviors – that people self-report them and may misremember or misreport them.

Another limitation is the potential for self-selection bias, as participation level was 36.4%, though the authors noted that is not unusual for unsolicited telephone surveys.

Dr. Cagande said that fearing loss of control may be another factor at play in having to follow restrictions, such as quarantining and masking, social distancing, or mandated vaccinations.

She said it’s important to understand a person’s reason for hesitancy to vaccines and work with the person with the help of the community, to help them trust and feel safe.
 

Young adults of particular concern

The 18- to 29-year-old age group is of particular concern, Dr. Bellis said.

The researchers estimated the likely rates of vaccine hesitancy according to childhood trauma and age, and the numbers ranged from around 3.5% among those aged 70 and older with no experience of childhood adversity to 38% among 18- to 29-year-olds who had experienced four or more types of childhood trauma.

“Childhood adversity can be an especially raw issue in this group,” he explained. “Some have already been obliged to sacrifice substantial proportions of their teenage lives and some will have suffered greater exposure to adverse childhood experiences as a result of being isolated during the pandemic, sometimes in difficult home environments. Our results suggest that this age group and especially those with high levels of ACEs are some of the most likely to be vaccine hesitant.”

This work was supported by Public Health Wales. The study authors and Dr. Cagande reported no relevant financial relationships.

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

COVID-19 vaccine hesitancy may be associated with traumatic events in childhood that undermine trust, including domestic violence, substance abuse in the home, or neglect, data published Feb. 1 suggest.

The findings by Mark A. Bellis, DSc, College of Human Sciences, Bangor (Wales) University, and colleagues were published online in BMJ Open.

The results are especially significant, the authors say, because of the prevalence of adverse childhood experiences (ACEs) globally, with proportions of people having multiple traumas in some countries at 10% or more of the population.

The authors wrote that hesitancy or refusal to get the vaccine increased with the number of traumas reported.

For example, hesitancy was three times higher among people who had experienced four or more types of childhood trauma than among those who did not report any traumatic events.

Dr. Bellis told this news organization that though their work suggests that higher levels of ACEs are linked with higher vaccine hesitancy, it is by no means the only reason people choose not to get vaccinated.

However, he said, the association they found may have key messages for clinicians.

“For clinicians, simply being trauma informed can help,” Dr. Bellis said. “Understanding how such childhood adversity can affect people may help them when discussing vaccines, and in understanding resistance to what is a complex medical issue and one that requires considerable trust. What can appear routine to a clinician may be a difficult leap of faith especially for those who have poorer experiences of trusting even within family settings.”
 

More trauma, less trust

The authors used responses to a nationally representative telephone survey of adults in Wales taken between December 2020 and March 2021, when COVID-19 restrictions were in force. Out of 6,763 people contacted, 2,285 met all criteria and answered all the questions and were included in the final analysis.

The survey asked about nine types of ACEs before the age of 18, including: parental separation; physical, verbal, and sexual abuse; exposure to domestic violence; and living with a household member who has mental illness, misuses alcohol and/or drugs, or who was incarcerated.

It also included personal details and long-term health information.

About half of the respondents said they hadn’t experienced any childhood trauma. Of those who did, one in five said they had experienced one type, 17% reported two to three types, and 10% reported four or more.

According to the authors, prevalence of ACEs reported was consistent with other comparable population surveys, including those conducted face to face.

They also investigated measures of trust and preference for different health regulations.

People with more ACEs were more likely to have low trust in National Health Service COVID-19 information.

“Other sociodemographics and a history of either chronic disease or COVID-19 infection were not significantly associated with low trust,” the authors pointed out.

People reporting higher ACEs also were more likely to report that they felt they were unfairly restricted by the government. People with four or more ACEs were twice as likely than were those with no ACEs to say they felt unfairly restricted and wanted rules such as mandatory masking to stop.

People with four or more types of trauma were almost twice as likely to ignore the restrictions as were those who hadn’t experienced any – 38% versus 21% – to ignore the restrictions, even after the researchers accounted for associations with sociodemographic factors and previous COVID-19 infection or a history of long-term conditions. 

“Clinicians can be a powerful voice to counter more alarmist or even conspiratorial messages that might otherwise resonate with those who find trust difficult,” Dr. Bellis said.

He said that the effect of childhood adversity needs to be considered at all levels in health systems. Overarching public health strategists should include ways to earn trust to counter resistance in some of the most vulnerable communities where ACEs can be higher.

It will also be important in the short-term to “provide reassurance, build community champions, and understand the low base from which trust needs to be built,” he said.
 

Loss of control

“Past traumatic experiences can predispose someone to avoid things that remind them of that trauma. This avoidance protects them from re-experiencing the negative symptoms and behaviors that come with it. Whether this results into hesitancy of something that would benefit their health is not well known,” Consuelo Cagande, MD, senior associate program director and fellowship adviser in the department of child and adolescent psychiatry and behavioral sciences, Children’s Hospital of Philadelphia, told this news organization.

She pointed out a limitation the authors mention that is common when using ACEs as a measure linking to future negative behaviors – that people self-report them and may misremember or misreport them.

Another limitation is the potential for self-selection bias, as participation level was 36.4%, though the authors noted that is not unusual for unsolicited telephone surveys.

Dr. Cagande said that fearing loss of control may be another factor at play in having to follow restrictions, such as quarantining and masking, social distancing, or mandated vaccinations.

She said it’s important to understand a person’s reason for hesitancy to vaccines and work with the person with the help of the community, to help them trust and feel safe.
 

Young adults of particular concern

The 18- to 29-year-old age group is of particular concern, Dr. Bellis said.

The researchers estimated the likely rates of vaccine hesitancy according to childhood trauma and age, and the numbers ranged from around 3.5% among those aged 70 and older with no experience of childhood adversity to 38% among 18- to 29-year-olds who had experienced four or more types of childhood trauma.

“Childhood adversity can be an especially raw issue in this group,” he explained. “Some have already been obliged to sacrifice substantial proportions of their teenage lives and some will have suffered greater exposure to adverse childhood experiences as a result of being isolated during the pandemic, sometimes in difficult home environments. Our results suggest that this age group and especially those with high levels of ACEs are some of the most likely to be vaccine hesitant.”

This work was supported by Public Health Wales. The study authors and Dr. Cagande reported no relevant financial relationships.

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

COVID-19 vaccine hesitancy may be associated with traumatic events in childhood that undermine trust, including domestic violence, substance abuse in the home, or neglect, data published Feb. 1 suggest.

The findings by Mark A. Bellis, DSc, College of Human Sciences, Bangor (Wales) University, and colleagues were published online in BMJ Open.

The results are especially significant, the authors say, because of the prevalence of adverse childhood experiences (ACEs) globally, with proportions of people having multiple traumas in some countries at 10% or more of the population.

The authors wrote that hesitancy or refusal to get the vaccine increased with the number of traumas reported.

For example, hesitancy was three times higher among people who had experienced four or more types of childhood trauma than among those who did not report any traumatic events.

Dr. Bellis told this news organization that though their work suggests that higher levels of ACEs are linked with higher vaccine hesitancy, it is by no means the only reason people choose not to get vaccinated.

However, he said, the association they found may have key messages for clinicians.

“For clinicians, simply being trauma informed can help,” Dr. Bellis said. “Understanding how such childhood adversity can affect people may help them when discussing vaccines, and in understanding resistance to what is a complex medical issue and one that requires considerable trust. What can appear routine to a clinician may be a difficult leap of faith especially for those who have poorer experiences of trusting even within family settings.”
 

More trauma, less trust

The authors used responses to a nationally representative telephone survey of adults in Wales taken between December 2020 and March 2021, when COVID-19 restrictions were in force. Out of 6,763 people contacted, 2,285 met all criteria and answered all the questions and were included in the final analysis.

The survey asked about nine types of ACEs before the age of 18, including: parental separation; physical, verbal, and sexual abuse; exposure to domestic violence; and living with a household member who has mental illness, misuses alcohol and/or drugs, or who was incarcerated.

It also included personal details and long-term health information.

About half of the respondents said they hadn’t experienced any childhood trauma. Of those who did, one in five said they had experienced one type, 17% reported two to three types, and 10% reported four or more.

According to the authors, prevalence of ACEs reported was consistent with other comparable population surveys, including those conducted face to face.

They also investigated measures of trust and preference for different health regulations.

People with more ACEs were more likely to have low trust in National Health Service COVID-19 information.

“Other sociodemographics and a history of either chronic disease or COVID-19 infection were not significantly associated with low trust,” the authors pointed out.

People reporting higher ACEs also were more likely to report that they felt they were unfairly restricted by the government. People with four or more ACEs were twice as likely than were those with no ACEs to say they felt unfairly restricted and wanted rules such as mandatory masking to stop.

People with four or more types of trauma were almost twice as likely to ignore the restrictions as were those who hadn’t experienced any – 38% versus 21% – to ignore the restrictions, even after the researchers accounted for associations with sociodemographic factors and previous COVID-19 infection or a history of long-term conditions. 

“Clinicians can be a powerful voice to counter more alarmist or even conspiratorial messages that might otherwise resonate with those who find trust difficult,” Dr. Bellis said.

He said that the effect of childhood adversity needs to be considered at all levels in health systems. Overarching public health strategists should include ways to earn trust to counter resistance in some of the most vulnerable communities where ACEs can be higher.

It will also be important in the short-term to “provide reassurance, build community champions, and understand the low base from which trust needs to be built,” he said.
 

Loss of control

“Past traumatic experiences can predispose someone to avoid things that remind them of that trauma. This avoidance protects them from re-experiencing the negative symptoms and behaviors that come with it. Whether this results into hesitancy of something that would benefit their health is not well known,” Consuelo Cagande, MD, senior associate program director and fellowship adviser in the department of child and adolescent psychiatry and behavioral sciences, Children’s Hospital of Philadelphia, told this news organization.

She pointed out a limitation the authors mention that is common when using ACEs as a measure linking to future negative behaviors – that people self-report them and may misremember or misreport them.

Another limitation is the potential for self-selection bias, as participation level was 36.4%, though the authors noted that is not unusual for unsolicited telephone surveys.

Dr. Cagande said that fearing loss of control may be another factor at play in having to follow restrictions, such as quarantining and masking, social distancing, or mandated vaccinations.

She said it’s important to understand a person’s reason for hesitancy to vaccines and work with the person with the help of the community, to help them trust and feel safe.
 

Young adults of particular concern

The 18- to 29-year-old age group is of particular concern, Dr. Bellis said.

The researchers estimated the likely rates of vaccine hesitancy according to childhood trauma and age, and the numbers ranged from around 3.5% among those aged 70 and older with no experience of childhood adversity to 38% among 18- to 29-year-olds who had experienced four or more types of childhood trauma.

“Childhood adversity can be an especially raw issue in this group,” he explained. “Some have already been obliged to sacrifice substantial proportions of their teenage lives and some will have suffered greater exposure to adverse childhood experiences as a result of being isolated during the pandemic, sometimes in difficult home environments. Our results suggest that this age group and especially those with high levels of ACEs are some of the most likely to be vaccine hesitant.”

This work was supported by Public Health Wales. The study authors and Dr. Cagande reported no relevant financial relationships.

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

Mask-wearing in childcare programs is linked with fewer COVID-19–related program closures, new data released suggest.

Researchers included 6,654 childcare professionals in a prospective, 1-year, longitudinal electronic survey study of home- and center-based childcare programs in all 50 states.

Findings by Thomas S. Murray, MD, PhD, with the department of pediatrics, Yale University, New Haven, Conn., and coauthors, were published in JAMA Network Open on Jan. 28, 2022.

They found that mask-wearing from the May 22, 2020, baseline to June 8, 2020, was associated with a 13% reduction in program closures within the following year (adjusted relative risk, 0.87; 95% confidence interval, 0.77-0.99). Continued mask-wearing throughout the 1-year follow-up was associated with a 14% reduction in program closures (aRR, 0.86; 95% CI, 0.74-1.00).

The authors said the evidence supports current masking recommendation in younger children provided by the Centers for Disease Control and Prevention.

They wrote: “This finding has important public health policy implications for families that rely on childcare to sustain employment.”

The benefits of masking in preventing COVID-19 transmission within kindergarten through 12th-grade classes are well documented. Masks are particularly important in areas where vaccinations are not widespread.

Masks can be worn safely by young children without harming respiratory function, studies have shown.

William Schaffner, MD, an infectious disease expert at Vanderbilt University, Nashville, Tenn., pointed out that the American Academy of Pediatrics has said there are no noteworthy effects on breathing function for most children.

“There’s been so much discussion about the contribution of masks to reducing the risk of COVID that it’s nice to have the data,” he said, adding that this is a relationship that has been difficult to study, but this analysis was able to make the connection with hard numbers.

“It’s an important outcome,” he said in an interview.

The authors pointed out there is evidence that school-age children can identify most emotions in masked faces.

They added that “2-year-old children recognize spoken words better through an opaque mask, compared with a clear face shield, suggesting verbal communication to infants is not harmed by face masks.”

Studies have shown that childhood infection with other respiratory viruses also decreased and asthma symptoms were not reported when preschool children wore masks and used other preventative steps.

The authors wrote that a potential reason for that may be that those who wear masks have less face touching, known to increase the spread of COVID-19.

Paloma Beamer, PhD, an engineer and exposure scientist at University of Arizona, Tucson, who also has a 3-year-old son who wears masks at his daycare center, said in an interview that she works closely with his school on training kids how to wear their masks because getting young children to keep them on and finding ones that fit is challenging.

“We need layered controls and protections in place at schools as much as possible,” she said, adding that the authors didn’t mention ventilation, but that’s another important component as well.

“We’re fortunate in Arizona that we are in an old school and the windows are open as much as possible,” she said.

She said this study shows that “masks are a great form of additional control.” Her son is on his third quarantine this month after three kids tested positive, she added.

She said: “I think these newer variants perhaps make the findings of this study more compelling and it will be interesting to see if the researchers do a follow-up study.”

Strengths of the study include that it utilized prospective data from a large national cohort of childcare professionals. Additionally, the retention rate was high at 1 year. And the self-reported information likely gives better information than looking at policies that may or may not be well followed.

Limitations include potential reporting bias because the self-reports were not independently confirmed. Also, family behavior outside childcare, such as social gatherings where masking is not enforced, also influence COVID-19 cases when children gather and may affect the numbers of closures.

Having the option of childcare centers benefits kids with in-person early education and social interactions with staff, the authors noted. The centers also help parents return to work without interruptions at home.

“Our findings support current national recommendations endorsed by many local and state governments for masking children 2 years and older in childcare programs when community COVID-19 transmission levels are elevated,” the authors wrote.

Dr. Schaffner said the results have implications outside of childcare centers and should be included in discussions of masking in schools and in the general public.

All phases of this study were supported by and coauthors report grants from the Andrew & Julie Klingenstein Family Fund, Esther A. & Joseph Klingenstein Fund, Heising-Simons Foundation, W.K. Kellogg Foundation, Foundation for Child Development, Early Educator Investment Collaborative, and Scholastic. The study was partially funded by the Yale Institute for Global Health. Dr. Schaffner and Dr. Beamer reported no relevant financial relationships.

Mask-wearing in childcare programs is linked with fewer COVID-19–related program closures, new data released suggest.

Researchers included 6,654 childcare professionals in a prospective, 1-year, longitudinal electronic survey study of home- and center-based childcare programs in all 50 states.

Findings by Thomas S. Murray, MD, PhD, with the department of pediatrics, Yale University, New Haven, Conn., and coauthors, were published in JAMA Network Open on Jan. 28, 2022.

They found that mask-wearing from the May 22, 2020, baseline to June 8, 2020, was associated with a 13% reduction in program closures within the following year (adjusted relative risk, 0.87; 95% confidence interval, 0.77-0.99). Continued mask-wearing throughout the 1-year follow-up was associated with a 14% reduction in program closures (aRR, 0.86; 95% CI, 0.74-1.00).

The authors said the evidence supports current masking recommendation in younger children provided by the Centers for Disease Control and Prevention.

They wrote: “This finding has important public health policy implications for families that rely on childcare to sustain employment.”

The benefits of masking in preventing COVID-19 transmission within kindergarten through 12th-grade classes are well documented. Masks are particularly important in areas where vaccinations are not widespread.

Masks can be worn safely by young children without harming respiratory function, studies have shown.

William Schaffner, MD, an infectious disease expert at Vanderbilt University, Nashville, Tenn., pointed out that the American Academy of Pediatrics has said there are no noteworthy effects on breathing function for most children.

“There’s been so much discussion about the contribution of masks to reducing the risk of COVID that it’s nice to have the data,” he said, adding that this is a relationship that has been difficult to study, but this analysis was able to make the connection with hard numbers.

“It’s an important outcome,” he said in an interview.

The authors pointed out there is evidence that school-age children can identify most emotions in masked faces.

They added that “2-year-old children recognize spoken words better through an opaque mask, compared with a clear face shield, suggesting verbal communication to infants is not harmed by face masks.”

Studies have shown that childhood infection with other respiratory viruses also decreased and asthma symptoms were not reported when preschool children wore masks and used other preventative steps.

The authors wrote that a potential reason for that may be that those who wear masks have less face touching, known to increase the spread of COVID-19.

Paloma Beamer, PhD, an engineer and exposure scientist at University of Arizona, Tucson, who also has a 3-year-old son who wears masks at his daycare center, said in an interview that she works closely with his school on training kids how to wear their masks because getting young children to keep them on and finding ones that fit is challenging.

“We need layered controls and protections in place at schools as much as possible,” she said, adding that the authors didn’t mention ventilation, but that’s another important component as well.

“We’re fortunate in Arizona that we are in an old school and the windows are open as much as possible,” she said.

She said this study shows that “masks are a great form of additional control.” Her son is on his third quarantine this month after three kids tested positive, she added.

She said: “I think these newer variants perhaps make the findings of this study more compelling and it will be interesting to see if the researchers do a follow-up study.”

Strengths of the study include that it utilized prospective data from a large national cohort of childcare professionals. Additionally, the retention rate was high at 1 year. And the self-reported information likely gives better information than looking at policies that may or may not be well followed.

Limitations include potential reporting bias because the self-reports were not independently confirmed. Also, family behavior outside childcare, such as social gatherings where masking is not enforced, also influence COVID-19 cases when children gather and may affect the numbers of closures.

Having the option of childcare centers benefits kids with in-person early education and social interactions with staff, the authors noted. The centers also help parents return to work without interruptions at home.

“Our findings support current national recommendations endorsed by many local and state governments for masking children 2 years and older in childcare programs when community COVID-19 transmission levels are elevated,” the authors wrote.

Dr. Schaffner said the results have implications outside of childcare centers and should be included in discussions of masking in schools and in the general public.

All phases of this study were supported by and coauthors report grants from the Andrew & Julie Klingenstein Family Fund, Esther A. & Joseph Klingenstein Fund, Heising-Simons Foundation, W.K. Kellogg Foundation, Foundation for Child Development, Early Educator Investment Collaborative, and Scholastic. The study was partially funded by the Yale Institute for Global Health. Dr. Schaffner and Dr. Beamer reported no relevant financial relationships.

Mask-wearing in childcare programs is linked with fewer COVID-19–related program closures, new data released suggest.

Researchers included 6,654 childcare professionals in a prospective, 1-year, longitudinal electronic survey study of home- and center-based childcare programs in all 50 states.

Findings by Thomas S. Murray, MD, PhD, with the department of pediatrics, Yale University, New Haven, Conn., and coauthors, were published in JAMA Network Open on Jan. 28, 2022.

They found that mask-wearing from the May 22, 2020, baseline to June 8, 2020, was associated with a 13% reduction in program closures within the following year (adjusted relative risk, 0.87; 95% confidence interval, 0.77-0.99). Continued mask-wearing throughout the 1-year follow-up was associated with a 14% reduction in program closures (aRR, 0.86; 95% CI, 0.74-1.00).

The authors said the evidence supports current masking recommendation in younger children provided by the Centers for Disease Control and Prevention.

They wrote: “This finding has important public health policy implications for families that rely on childcare to sustain employment.”

The benefits of masking in preventing COVID-19 transmission within kindergarten through 12th-grade classes are well documented. Masks are particularly important in areas where vaccinations are not widespread.

Masks can be worn safely by young children without harming respiratory function, studies have shown.

William Schaffner, MD, an infectious disease expert at Vanderbilt University, Nashville, Tenn., pointed out that the American Academy of Pediatrics has said there are no noteworthy effects on breathing function for most children.

“There’s been so much discussion about the contribution of masks to reducing the risk of COVID that it’s nice to have the data,” he said, adding that this is a relationship that has been difficult to study, but this analysis was able to make the connection with hard numbers.

“It’s an important outcome,” he said in an interview.

The authors pointed out there is evidence that school-age children can identify most emotions in masked faces.

They added that “2-year-old children recognize spoken words better through an opaque mask, compared with a clear face shield, suggesting verbal communication to infants is not harmed by face masks.”

Studies have shown that childhood infection with other respiratory viruses also decreased and asthma symptoms were not reported when preschool children wore masks and used other preventative steps.

The authors wrote that a potential reason for that may be that those who wear masks have less face touching, known to increase the spread of COVID-19.

Paloma Beamer, PhD, an engineer and exposure scientist at University of Arizona, Tucson, who also has a 3-year-old son who wears masks at his daycare center, said in an interview that she works closely with his school on training kids how to wear their masks because getting young children to keep them on and finding ones that fit is challenging.

“We need layered controls and protections in place at schools as much as possible,” she said, adding that the authors didn’t mention ventilation, but that’s another important component as well.

“We’re fortunate in Arizona that we are in an old school and the windows are open as much as possible,” she said.

She said this study shows that “masks are a great form of additional control.” Her son is on his third quarantine this month after three kids tested positive, she added.

She said: “I think these newer variants perhaps make the findings of this study more compelling and it will be interesting to see if the researchers do a follow-up study.”

Strengths of the study include that it utilized prospective data from a large national cohort of childcare professionals. Additionally, the retention rate was high at 1 year. And the self-reported information likely gives better information than looking at policies that may or may not be well followed.

Limitations include potential reporting bias because the self-reports were not independently confirmed. Also, family behavior outside childcare, such as social gatherings where masking is not enforced, also influence COVID-19 cases when children gather and may affect the numbers of closures.

Having the option of childcare centers benefits kids with in-person early education and social interactions with staff, the authors noted. The centers also help parents return to work without interruptions at home.

“Our findings support current national recommendations endorsed by many local and state governments for masking children 2 years and older in childcare programs when community COVID-19 transmission levels are elevated,” the authors wrote.

Dr. Schaffner said the results have implications outside of childcare centers and should be included in discussions of masking in schools and in the general public.

All phases of this study were supported by and coauthors report grants from the Andrew & Julie Klingenstein Family Fund, Esther A. & Joseph Klingenstein Fund, Heising-Simons Foundation, W.K. Kellogg Foundation, Foundation for Child Development, Early Educator Investment Collaborative, and Scholastic. The study was partially funded by the Yale Institute for Global Health. Dr. Schaffner and Dr. Beamer reported no relevant financial relationships.

Weekly COVID-19 cases in children topped 1 million for the first time as the cumulative count surpassed 10 million since the start of the pandemic, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

There were 1.15 million cases of COVID-19 reported in children during the week of Jan. 14-20 in the United States, making it the fourth consecutive record-high week and bringing the total number of cases to 10.6 million, the AAP and CHA said in their weekly COVID report. Those 10.6 million child cases represent 18.4% of all cases, and the latest 1.15 million represented 25.5% of all cases for the week.

Regionally, the South had the most cases with over 380,000 for the week of Jan. 14-20, while the West was next with close to 350,000, followed by the Midwest and then the East. Among the states, the largest percent increases – on the order of 30% – came in New England (Massachusetts, Rhode Island, and Vermont), as well as Virginia and California, the AAP and CHA said.

Examining all those cases by vaccination status shows an obvious difference between the Omicron and Delta variants: The fully vaccinated have been hit much harder than before. For the week ending Dec. 25, 2021, the incidence of COVID-19 in children aged 12-17 years was 704 per 100,000 among those were unvaccinated and 384 per 100,000 in those who were fully vaccinated. During the Delta surge in the summer of 2021, the peak rates were 938 (unvaccinated) and 79 (vaccinated), the Centers for Disease Control and Prevention said.

Hospitalizations are also at record levels, but two separate CDC databases seem to show a decline in child admissions over the last available week or so of data, which follows the trend among all ages. The peak among children aged 0-17 years came on Jan. 15, when the rate of new admissions reached 1.25 per 100,000, based on reporting to the CDC from 5,265 hospitals nationwide.

The second database, the COVID-19–Associated Hospitalization Surveillance Network (COVID-NET), indicates that children aged 0-4 years had the highest admission rate, 14.5 per 100,000, for the week ending Jan. 8, compared with 5.5 per 100,000 for 12- to 17-year-olds and 2.3 per 100,000 for those aged 5-11 years. COVID-NET covers almost 100 counties in 10 states, along with 4 entire states, and represents about 10% of the U.S. population.

Vaccinations rose briefly in late December and into January to meet the Omicron surge, but the numbers for the latest week show a return to their earlier levels. In children aged 5-11 years, new vaccinations went from 381,000 for the week of Dec. 20-26 to 524,000 for Jan. 3-9, but fell to just 260,000 during Jan. 17-23. The response was a little later for those aged 12-17, with the big week coming Jan. 10-16, but there was still a 38% drop for Jan. 17-23, according to the CDC’s COVID Data Tracker.

Currently, 29.3% of all 5- to 11-year-olds have received at least one dose of the COVID vaccine, and an even 20.0% are fully vaccinated. For children aged 12-17, the corresponding figures are 65.8% and 55.1%, the CDC said.

Statewide vaccination rates vary from Vermont’s high of 61% for those aged 5-11 to 12% for Alabama, Louisiana, and Mississippi, while Hawaii has the highest rate for 12- to 17-year-olds at 92% and Wyoming has the lowest at 39%, the AAP reported.

 

Weekly COVID-19 cases in children topped 1 million for the first time as the cumulative count surpassed 10 million since the start of the pandemic, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

There were 1.15 million cases of COVID-19 reported in children during the week of Jan. 14-20 in the United States, making it the fourth consecutive record-high week and bringing the total number of cases to 10.6 million, the AAP and CHA said in their weekly COVID report. Those 10.6 million child cases represent 18.4% of all cases, and the latest 1.15 million represented 25.5% of all cases for the week.

Regionally, the South had the most cases with over 380,000 for the week of Jan. 14-20, while the West was next with close to 350,000, followed by the Midwest and then the East. Among the states, the largest percent increases – on the order of 30% – came in New England (Massachusetts, Rhode Island, and Vermont), as well as Virginia and California, the AAP and CHA said.

Examining all those cases by vaccination status shows an obvious difference between the Omicron and Delta variants: The fully vaccinated have been hit much harder than before. For the week ending Dec. 25, 2021, the incidence of COVID-19 in children aged 12-17 years was 704 per 100,000 among those were unvaccinated and 384 per 100,000 in those who were fully vaccinated. During the Delta surge in the summer of 2021, the peak rates were 938 (unvaccinated) and 79 (vaccinated), the Centers for Disease Control and Prevention said.

Hospitalizations are also at record levels, but two separate CDC databases seem to show a decline in child admissions over the last available week or so of data, which follows the trend among all ages. The peak among children aged 0-17 years came on Jan. 15, when the rate of new admissions reached 1.25 per 100,000, based on reporting to the CDC from 5,265 hospitals nationwide.

The second database, the COVID-19–Associated Hospitalization Surveillance Network (COVID-NET), indicates that children aged 0-4 years had the highest admission rate, 14.5 per 100,000, for the week ending Jan. 8, compared with 5.5 per 100,000 for 12- to 17-year-olds and 2.3 per 100,000 for those aged 5-11 years. COVID-NET covers almost 100 counties in 10 states, along with 4 entire states, and represents about 10% of the U.S. population.

Vaccinations rose briefly in late December and into January to meet the Omicron surge, but the numbers for the latest week show a return to their earlier levels. In children aged 5-11 years, new vaccinations went from 381,000 for the week of Dec. 20-26 to 524,000 for Jan. 3-9, but fell to just 260,000 during Jan. 17-23. The response was a little later for those aged 12-17, with the big week coming Jan. 10-16, but there was still a 38% drop for Jan. 17-23, according to the CDC’s COVID Data Tracker.

Currently, 29.3% of all 5- to 11-year-olds have received at least one dose of the COVID vaccine, and an even 20.0% are fully vaccinated. For children aged 12-17, the corresponding figures are 65.8% and 55.1%, the CDC said.

Statewide vaccination rates vary from Vermont’s high of 61% for those aged 5-11 to 12% for Alabama, Louisiana, and Mississippi, while Hawaii has the highest rate for 12- to 17-year-olds at 92% and Wyoming has the lowest at 39%, the AAP reported.

 

Weekly COVID-19 cases in children topped 1 million for the first time as the cumulative count surpassed 10 million since the start of the pandemic, based on data from the American Academy of Pediatrics and the Children’s Hospital Association.

There were 1.15 million cases of COVID-19 reported in children during the week of Jan. 14-20 in the United States, making it the fourth consecutive record-high week and bringing the total number of cases to 10.6 million, the AAP and CHA said in their weekly COVID report. Those 10.6 million child cases represent 18.4% of all cases, and the latest 1.15 million represented 25.5% of all cases for the week.

Regionally, the South had the most cases with over 380,000 for the week of Jan. 14-20, while the West was next with close to 350,000, followed by the Midwest and then the East. Among the states, the largest percent increases – on the order of 30% – came in New England (Massachusetts, Rhode Island, and Vermont), as well as Virginia and California, the AAP and CHA said.

Examining all those cases by vaccination status shows an obvious difference between the Omicron and Delta variants: The fully vaccinated have been hit much harder than before. For the week ending Dec. 25, 2021, the incidence of COVID-19 in children aged 12-17 years was 704 per 100,000 among those were unvaccinated and 384 per 100,000 in those who were fully vaccinated. During the Delta surge in the summer of 2021, the peak rates were 938 (unvaccinated) and 79 (vaccinated), the Centers for Disease Control and Prevention said.

Hospitalizations are also at record levels, but two separate CDC databases seem to show a decline in child admissions over the last available week or so of data, which follows the trend among all ages. The peak among children aged 0-17 years came on Jan. 15, when the rate of new admissions reached 1.25 per 100,000, based on reporting to the CDC from 5,265 hospitals nationwide.

The second database, the COVID-19–Associated Hospitalization Surveillance Network (COVID-NET), indicates that children aged 0-4 years had the highest admission rate, 14.5 per 100,000, for the week ending Jan. 8, compared with 5.5 per 100,000 for 12- to 17-year-olds and 2.3 per 100,000 for those aged 5-11 years. COVID-NET covers almost 100 counties in 10 states, along with 4 entire states, and represents about 10% of the U.S. population.

Vaccinations rose briefly in late December and into January to meet the Omicron surge, but the numbers for the latest week show a return to their earlier levels. In children aged 5-11 years, new vaccinations went from 381,000 for the week of Dec. 20-26 to 524,000 for Jan. 3-9, but fell to just 260,000 during Jan. 17-23. The response was a little later for those aged 12-17, with the big week coming Jan. 10-16, but there was still a 38% drop for Jan. 17-23, according to the CDC’s COVID Data Tracker.

Currently, 29.3% of all 5- to 11-year-olds have received at least one dose of the COVID vaccine, and an even 20.0% are fully vaccinated. For children aged 12-17, the corresponding figures are 65.8% and 55.1%, the CDC said.

Statewide vaccination rates vary from Vermont’s high of 61% for those aged 5-11 to 12% for Alabama, Louisiana, and Mississippi, while Hawaii has the highest rate for 12- to 17-year-olds at 92% and Wyoming has the lowest at 39%, the AAP reported.

 

Two new studies from different parts of the world have identified an increase in the incidence of type 1 diabetes in children since the COVID-19 pandemic began, but the reasons still aren’t clear.

The findings from the two studies, in Germany and the United States, align closely, endocrinologist Jane J. Kim, MD, professor of pediatrics and principal investigator of the U.S. study, told this news organization. “I think that the general conclusion based on their data and our data is that there appears to be an increased rate of new type 1 diabetes diagnoses in children since the onset of the pandemic.”

Dr. Kim noted that because her group’s data pertain to just a single center, she is “heartened to see that the [German team’s] general conclusions are the same as ours.” Moreover, she pointed out that other studies examining this question came from Europe early in the pandemic, whereas “now both they [the German group] and we have had the opportunity to look at what’s happening over a longer period of time.”

But the reason for the association remains unclear. Some answers may be forthcoming from a database designed in mid-2020 specifically to examine the relationship between COVID-19 and new-onset diabetes. Called CoviDiab, the registry aims “to establish the extent and characteristics of new-onset, COVID-19–related diabetes and to investigate its pathogenesis, management, and outcomes,” according to the website.

The first new study, a multicenter German diabetes registry study, was published online Jan. 17 in Diabetes Care by Clemens Kamrath, MD, of Justus Liebig University, Giessen, Germany, and colleagues.

The other, from Rady Children’s Hospital of San Diego, was published online Jan. 24 in JAMA Pediatrics by Bethany L. Gottesman, MD, and colleagues, all with the University of California, San Diego.
 

Mechanisms likely to differ for type 1 versus type 2 diabetes

Neither the German nor the U.S. investigators were able to directly correlate current or prior SARS-CoV-2 infection in children with the subsequent development of type 1 diabetes.

Earlier this month, a study from the U.S. Centers for Disease Control and Prevention did examine that issue, but it also included youth with type 2 diabetes and did not separate out the two groups.

Dr. Kim said her institution has also seen an increase in type 2 diabetes among youth since the COVID-19 pandemic began but did not include that in their current article.

“When we started looking at our data, diabetes and COVID-19 in adults had been relatively well established. To see an increase in type 2 [diabetes] was not so surprising to our group. But we had the sense we were seeing more patients with type 1, and when we looked at our hospital that was very much the case. I think that was a surprise to people,” said Dr. Kim.

Although a direct effect of SARS-CoV-2 on pancreatic beta cells has been proposed, in both the German and San Diego datasets the diagnosis of type 1 diabetes was confirmed with autoantibodies that are typically present years prior to the onset of clinical symptoms.

The German group suggests possible other explanations for the link, including the lack of immune system exposure to other common pediatric infections during pandemic-necessitated social distancing – the so-called hygiene hypothesis – as well as the possible role of psychological stress, which several studies have linked to type 1 diabetes.

But as of now, Dr. Kim said, “Nobody really knows.” 
 

Is the effect direct or indirect?

Using data from the multicenter German Diabetes Prospective Follow-up Registry, Dr. Kamrath and colleagues compared the incidence of type 1 diabetes in children and adolescents from Jan. 1, 2020 through June 30, 2021 with the incidence in 2011-2019.

During the pandemic period, a total of 5,162 youth were newly diagnosed with type 1 diabetes at 236 German centers. That incidence, 24.4 per 100,000 patient-years, was significantly higher than the 21.2 per 100,000 patient-years expected based on the prior decade, with an incidence rate ratio of 1.15 (P < .001). The increase was similar in both males and females.

There was a difference by age, however, as the phenomenon appeared to be limited to the preadolescent age groups. The incidence rate ratios (IRRs) for ages below 6 years and 6-11 years were 1.23 and 1.18 (both P < .001), respectively, compared to a nonsignificant IRR of 1.06 (P = .13) in those aged 12-17 years.

Compared with the expected monthly incidence, the observed incidence was significantly higher in June 2020 (IRR, 1.43; P = .003), July 2020 (IRR, 1.48; P < 0.001), March 2021 (IRR, 1.29; P = .028), and June 2021 (IRR, 1.39; P = .01).

Among the 3,851 patients for whom data on type 1 diabetes-associated autoantibodies were available, the adjusted rates of autoantibody negativity did not differ from 2018-2019 during the entire pandemic period or during the year 2020 or the first half of 2021.  

“Therefore, the increase in the incidence of type 1 diabetes in children appears to be due to immune-mediated type 1 diabetes. However, because autoimmunity and progressive beta-cell destruction typically begin long before the clinical diagnosis of type 1 diabetes, we were surprised to see the incidence of type 1 diabetes followed the peak incidence of COVID-19 and also the pandemic containment measures by only approximately 3 months,” Dr. Kamrath and colleagues write.

Taken together, they say, the data suggest that “the impact on type 1 diabetes incidence is not due to infection with SARS-CoV-2 but rather a consequence of environmental changes resulting from the pandemic itself or pandemic containment measures.”
 

Similar findings at a U.S. children’s hospital

In the cross-sectional study in San Diego, Dr. Gottesman and colleagues looked at the electronic medical records (EMRs) at Rady Children’s Hospital for patients aged younger than 19 years with at least one positive type 1 diabetes antibody titer.

During March 19, 2020 to March 18, 2021, a total of 187 children were admitted for new-onset type 1 diabetes, compared with just 119 the previous year, a 57% increase.

From July 2020 through February 2021, the number of new type 1 diabetes diagnoses significantly exceeded the number expected based on a quarterly moving average of each of the preceding 5 years.

Only four of the 187 patients (2.1%) diagnosed during the pandemic period had a COVID-19 infection at the time of presentation. Antibody testing to assess prior infection wasn’t feasible, and now that children are receiving the vaccine – and therefore most will have antibodies – “we’ve lost our window of opportunity to look at that question,” Dr. Kim noted.   

As has been previously shown, there was an increase in the percentage of patients presenting with diabetic ketoacidosis during the pandemic compared with the prior 5 years (49.7% vs. 40.7% requiring insulin infusion). However, there was no difference in mean age at presentation, body mass index, A1c, or percentage requiring admission to intensive care.

Because these data only go through March 2021, Dr. Kim noted, “We need to see what’s happening with these different variants. We’ll have a chance to look in a month or two to see the effects of Omicron on the rates of diabetes in the hospital.”
 

Will CoviDiab answer the question?

Data from CoviDiab will include diabetes type in adults and children, registry coprincipal investigator Francesco Rubino, MD, of King’s College London, told this news organization.

“We aimed at having as many as possible cases of new-onset diabetes for which we can have also a minimum set of clinical data including type of diabetes and A1c. By looking at this information we can infer whether a role of COVID-19 in triggering diabetes is clinically plausible – or not – and what type of diabetes is most frequently associated with COVID-19 as this also speaks about mechanisms of action.”

Dr. Rubino said that the CoviDiab team is approaching the data with the assumption that, at least in adults diagnosed with type 2 diabetes, the explanation might be that the person already had undiagnosed diabetes or that the hyperglycemia may be stress-induced and temporary.

“We’re looking at this question with a skeptical eye ... Is it just an association, or does the virus have a role in inducing diabetes from scratch, or can the virus advance pathophysiology in a way that it ends up in full-blown diabetes in predisposed individuals?”

While no single study will prove that SARS-CoV-2 causes diabetes, “combining observations from various studies and approaches we may get a higher degree of certainty,” Dr. Rubino said, noting that the CoviDiab team plans to publish data from the first 800 cases “soon.”

Dr. Kim has reported no relevant financial relationships. Dr. Rubino has reported receiving grants from Ethicon and Medtronic, personal fees from GI Dynamic, Keyron, Novo Nordisk, Ethicon, and Medtronic.

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

Two new studies from different parts of the world have identified an increase in the incidence of type 1 diabetes in children since the COVID-19 pandemic began, but the reasons still aren’t clear.

The findings from the two studies, in Germany and the United States, align closely, endocrinologist Jane J. Kim, MD, professor of pediatrics and principal investigator of the U.S. study, told this news organization. “I think that the general conclusion based on their data and our data is that there appears to be an increased rate of new type 1 diabetes diagnoses in children since the onset of the pandemic.”

Dr. Kim noted that because her group’s data pertain to just a single center, she is “heartened to see that the [German team’s] general conclusions are the same as ours.” Moreover, she pointed out that other studies examining this question came from Europe early in the pandemic, whereas “now both they [the German group] and we have had the opportunity to look at what’s happening over a longer period of time.”

But the reason for the association remains unclear. Some answers may be forthcoming from a database designed in mid-2020 specifically to examine the relationship between COVID-19 and new-onset diabetes. Called CoviDiab, the registry aims “to establish the extent and characteristics of new-onset, COVID-19–related diabetes and to investigate its pathogenesis, management, and outcomes,” according to the website.

The first new study, a multicenter German diabetes registry study, was published online Jan. 17 in Diabetes Care by Clemens Kamrath, MD, of Justus Liebig University, Giessen, Germany, and colleagues.

The other, from Rady Children’s Hospital of San Diego, was published online Jan. 24 in JAMA Pediatrics by Bethany L. Gottesman, MD, and colleagues, all with the University of California, San Diego.
 

Mechanisms likely to differ for type 1 versus type 2 diabetes

Neither the German nor the U.S. investigators were able to directly correlate current or prior SARS-CoV-2 infection in children with the subsequent development of type 1 diabetes.

Earlier this month, a study from the U.S. Centers for Disease Control and Prevention did examine that issue, but it also included youth with type 2 diabetes and did not separate out the two groups.

Dr. Kim said her institution has also seen an increase in type 2 diabetes among youth since the COVID-19 pandemic began but did not include that in their current article.

“When we started looking at our data, diabetes and COVID-19 in adults had been relatively well established. To see an increase in type 2 [diabetes] was not so surprising to our group. But we had the sense we were seeing more patients with type 1, and when we looked at our hospital that was very much the case. I think that was a surprise to people,” said Dr. Kim.

Although a direct effect of SARS-CoV-2 on pancreatic beta cells has been proposed, in both the German and San Diego datasets the diagnosis of type 1 diabetes was confirmed with autoantibodies that are typically present years prior to the onset of clinical symptoms.

The German group suggests possible other explanations for the link, including the lack of immune system exposure to other common pediatric infections during pandemic-necessitated social distancing – the so-called hygiene hypothesis – as well as the possible role of psychological stress, which several studies have linked to type 1 diabetes.

But as of now, Dr. Kim said, “Nobody really knows.” 
 

Is the effect direct or indirect?

Using data from the multicenter German Diabetes Prospective Follow-up Registry, Dr. Kamrath and colleagues compared the incidence of type 1 diabetes in children and adolescents from Jan. 1, 2020 through June 30, 2021 with the incidence in 2011-2019.

During the pandemic period, a total of 5,162 youth were newly diagnosed with type 1 diabetes at 236 German centers. That incidence, 24.4 per 100,000 patient-years, was significantly higher than the 21.2 per 100,000 patient-years expected based on the prior decade, with an incidence rate ratio of 1.15 (P < .001). The increase was similar in both males and females.

There was a difference by age, however, as the phenomenon appeared to be limited to the preadolescent age groups. The incidence rate ratios (IRRs) for ages below 6 years and 6-11 years were 1.23 and 1.18 (both P < .001), respectively, compared to a nonsignificant IRR of 1.06 (P = .13) in those aged 12-17 years.

Compared with the expected monthly incidence, the observed incidence was significantly higher in June 2020 (IRR, 1.43; P = .003), July 2020 (IRR, 1.48; P < 0.001), March 2021 (IRR, 1.29; P = .028), and June 2021 (IRR, 1.39; P = .01).

Among the 3,851 patients for whom data on type 1 diabetes-associated autoantibodies were available, the adjusted rates of autoantibody negativity did not differ from 2018-2019 during the entire pandemic period or during the year 2020 or the first half of 2021.  

“Therefore, the increase in the incidence of type 1 diabetes in children appears to be due to immune-mediated type 1 diabetes. However, because autoimmunity and progressive beta-cell destruction typically begin long before the clinical diagnosis of type 1 diabetes, we were surprised to see the incidence of type 1 diabetes followed the peak incidence of COVID-19 and also the pandemic containment measures by only approximately 3 months,” Dr. Kamrath and colleagues write.

Taken together, they say, the data suggest that “the impact on type 1 diabetes incidence is not due to infection with SARS-CoV-2 but rather a consequence of environmental changes resulting from the pandemic itself or pandemic containment measures.”
 

Similar findings at a U.S. children’s hospital

In the cross-sectional study in San Diego, Dr. Gottesman and colleagues looked at the electronic medical records (EMRs) at Rady Children’s Hospital for patients aged younger than 19 years with at least one positive type 1 diabetes antibody titer.

During March 19, 2020 to March 18, 2021, a total of 187 children were admitted for new-onset type 1 diabetes, compared with just 119 the previous year, a 57% increase.

From July 2020 through February 2021, the number of new type 1 diabetes diagnoses significantly exceeded the number expected based on a quarterly moving average of each of the preceding 5 years.

Only four of the 187 patients (2.1%) diagnosed during the pandemic period had a COVID-19 infection at the time of presentation. Antibody testing to assess prior infection wasn’t feasible, and now that children are receiving the vaccine – and therefore most will have antibodies – “we’ve lost our window of opportunity to look at that question,” Dr. Kim noted.   

As has been previously shown, there was an increase in the percentage of patients presenting with diabetic ketoacidosis during the pandemic compared with the prior 5 years (49.7% vs. 40.7% requiring insulin infusion). However, there was no difference in mean age at presentation, body mass index, A1c, or percentage requiring admission to intensive care.

Because these data only go through March 2021, Dr. Kim noted, “We need to see what’s happening with these different variants. We’ll have a chance to look in a month or two to see the effects of Omicron on the rates of diabetes in the hospital.”
 

Will CoviDiab answer the question?

Data from CoviDiab will include diabetes type in adults and children, registry coprincipal investigator Francesco Rubino, MD, of King’s College London, told this news organization.

“We aimed at having as many as possible cases of new-onset diabetes for which we can have also a minimum set of clinical data including type of diabetes and A1c. By looking at this information we can infer whether a role of COVID-19 in triggering diabetes is clinically plausible – or not – and what type of diabetes is most frequently associated with COVID-19 as this also speaks about mechanisms of action.”

Dr. Rubino said that the CoviDiab team is approaching the data with the assumption that, at least in adults diagnosed with type 2 diabetes, the explanation might be that the person already had undiagnosed diabetes or that the hyperglycemia may be stress-induced and temporary.

“We’re looking at this question with a skeptical eye ... Is it just an association, or does the virus have a role in inducing diabetes from scratch, or can the virus advance pathophysiology in a way that it ends up in full-blown diabetes in predisposed individuals?”

While no single study will prove that SARS-CoV-2 causes diabetes, “combining observations from various studies and approaches we may get a higher degree of certainty,” Dr. Rubino said, noting that the CoviDiab team plans to publish data from the first 800 cases “soon.”

Dr. Kim has reported no relevant financial relationships. Dr. Rubino has reported receiving grants from Ethicon and Medtronic, personal fees from GI Dynamic, Keyron, Novo Nordisk, Ethicon, and Medtronic.

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

Two new studies from different parts of the world have identified an increase in the incidence of type 1 diabetes in children since the COVID-19 pandemic began, but the reasons still aren’t clear.

The findings from the two studies, in Germany and the United States, align closely, endocrinologist Jane J. Kim, MD, professor of pediatrics and principal investigator of the U.S. study, told this news organization. “I think that the general conclusion based on their data and our data is that there appears to be an increased rate of new type 1 diabetes diagnoses in children since the onset of the pandemic.”

Dr. Kim noted that because her group’s data pertain to just a single center, she is “heartened to see that the [German team’s] general conclusions are the same as ours.” Moreover, she pointed out that other studies examining this question came from Europe early in the pandemic, whereas “now both they [the German group] and we have had the opportunity to look at what’s happening over a longer period of time.”

But the reason for the association remains unclear. Some answers may be forthcoming from a database designed in mid-2020 specifically to examine the relationship between COVID-19 and new-onset diabetes. Called CoviDiab, the registry aims “to establish the extent and characteristics of new-onset, COVID-19–related diabetes and to investigate its pathogenesis, management, and outcomes,” according to the website.

The first new study, a multicenter German diabetes registry study, was published online Jan. 17 in Diabetes Care by Clemens Kamrath, MD, of Justus Liebig University, Giessen, Germany, and colleagues.

The other, from Rady Children’s Hospital of San Diego, was published online Jan. 24 in JAMA Pediatrics by Bethany L. Gottesman, MD, and colleagues, all with the University of California, San Diego.
 

Mechanisms likely to differ for type 1 versus type 2 diabetes

Neither the German nor the U.S. investigators were able to directly correlate current or prior SARS-CoV-2 infection in children with the subsequent development of type 1 diabetes.

Earlier this month, a study from the U.S. Centers for Disease Control and Prevention did examine that issue, but it also included youth with type 2 diabetes and did not separate out the two groups.

Dr. Kim said her institution has also seen an increase in type 2 diabetes among youth since the COVID-19 pandemic began but did not include that in their current article.

“When we started looking at our data, diabetes and COVID-19 in adults had been relatively well established. To see an increase in type 2 [diabetes] was not so surprising to our group. But we had the sense we were seeing more patients with type 1, and when we looked at our hospital that was very much the case. I think that was a surprise to people,” said Dr. Kim.

Although a direct effect of SARS-CoV-2 on pancreatic beta cells has been proposed, in both the German and San Diego datasets the diagnosis of type 1 diabetes was confirmed with autoantibodies that are typically present years prior to the onset of clinical symptoms.

The German group suggests possible other explanations for the link, including the lack of immune system exposure to other common pediatric infections during pandemic-necessitated social distancing – the so-called hygiene hypothesis – as well as the possible role of psychological stress, which several studies have linked to type 1 diabetes.

But as of now, Dr. Kim said, “Nobody really knows.” 
 

Is the effect direct or indirect?

Using data from the multicenter German Diabetes Prospective Follow-up Registry, Dr. Kamrath and colleagues compared the incidence of type 1 diabetes in children and adolescents from Jan. 1, 2020 through June 30, 2021 with the incidence in 2011-2019.

During the pandemic period, a total of 5,162 youth were newly diagnosed with type 1 diabetes at 236 German centers. That incidence, 24.4 per 100,000 patient-years, was significantly higher than the 21.2 per 100,000 patient-years expected based on the prior decade, with an incidence rate ratio of 1.15 (P < .001). The increase was similar in both males and females.

There was a difference by age, however, as the phenomenon appeared to be limited to the preadolescent age groups. The incidence rate ratios (IRRs) for ages below 6 years and 6-11 years were 1.23 and 1.18 (both P < .001), respectively, compared to a nonsignificant IRR of 1.06 (P = .13) in those aged 12-17 years.

Compared with the expected monthly incidence, the observed incidence was significantly higher in June 2020 (IRR, 1.43; P = .003), July 2020 (IRR, 1.48; P < 0.001), March 2021 (IRR, 1.29; P = .028), and June 2021 (IRR, 1.39; P = .01).

Among the 3,851 patients for whom data on type 1 diabetes-associated autoantibodies were available, the adjusted rates of autoantibody negativity did not differ from 2018-2019 during the entire pandemic period or during the year 2020 or the first half of 2021.  

“Therefore, the increase in the incidence of type 1 diabetes in children appears to be due to immune-mediated type 1 diabetes. However, because autoimmunity and progressive beta-cell destruction typically begin long before the clinical diagnosis of type 1 diabetes, we were surprised to see the incidence of type 1 diabetes followed the peak incidence of COVID-19 and also the pandemic containment measures by only approximately 3 months,” Dr. Kamrath and colleagues write.

Taken together, they say, the data suggest that “the impact on type 1 diabetes incidence is not due to infection with SARS-CoV-2 but rather a consequence of environmental changes resulting from the pandemic itself or pandemic containment measures.”
 

Similar findings at a U.S. children’s hospital

In the cross-sectional study in San Diego, Dr. Gottesman and colleagues looked at the electronic medical records (EMRs) at Rady Children’s Hospital for patients aged younger than 19 years with at least one positive type 1 diabetes antibody titer.

During March 19, 2020 to March 18, 2021, a total of 187 children were admitted for new-onset type 1 diabetes, compared with just 119 the previous year, a 57% increase.

From July 2020 through February 2021, the number of new type 1 diabetes diagnoses significantly exceeded the number expected based on a quarterly moving average of each of the preceding 5 years.

Only four of the 187 patients (2.1%) diagnosed during the pandemic period had a COVID-19 infection at the time of presentation. Antibody testing to assess prior infection wasn’t feasible, and now that children are receiving the vaccine – and therefore most will have antibodies – “we’ve lost our window of opportunity to look at that question,” Dr. Kim noted.   

As has been previously shown, there was an increase in the percentage of patients presenting with diabetic ketoacidosis during the pandemic compared with the prior 5 years (49.7% vs. 40.7% requiring insulin infusion). However, there was no difference in mean age at presentation, body mass index, A1c, or percentage requiring admission to intensive care.

Because these data only go through March 2021, Dr. Kim noted, “We need to see what’s happening with these different variants. We’ll have a chance to look in a month or two to see the effects of Omicron on the rates of diabetes in the hospital.”
 

Will CoviDiab answer the question?

Data from CoviDiab will include diabetes type in adults and children, registry coprincipal investigator Francesco Rubino, MD, of King’s College London, told this news organization.

“We aimed at having as many as possible cases of new-onset diabetes for which we can have also a minimum set of clinical data including type of diabetes and A1c. By looking at this information we can infer whether a role of COVID-19 in triggering diabetes is clinically plausible – or not – and what type of diabetes is most frequently associated with COVID-19 as this also speaks about mechanisms of action.”

Dr. Rubino said that the CoviDiab team is approaching the data with the assumption that, at least in adults diagnosed with type 2 diabetes, the explanation might be that the person already had undiagnosed diabetes or that the hyperglycemia may be stress-induced and temporary.

“We’re looking at this question with a skeptical eye ... Is it just an association, or does the virus have a role in inducing diabetes from scratch, or can the virus advance pathophysiology in a way that it ends up in full-blown diabetes in predisposed individuals?”

While no single study will prove that SARS-CoV-2 causes diabetes, “combining observations from various studies and approaches we may get a higher degree of certainty,” Dr. Rubino said, noting that the CoviDiab team plans to publish data from the first 800 cases “soon.”

Dr. Kim has reported no relevant financial relationships. Dr. Rubino has reported receiving grants from Ethicon and Medtronic, personal fees from GI Dynamic, Keyron, Novo Nordisk, Ethicon, and Medtronic.

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

In another salvo in the heated debate over treatment for kids who believe they’re transgender, a study published in PLoS One suggests that transgender adults who received hormone therapy as teenagers are mentally healthier in a pair of ways than those who didn’t.

The study, which only looks at transgender adults, doesn’t confirm that hormone therapy in childhood is a beneficial treatment. Still, “we found that for all age groups, access to [adolescent] gender-affirming hormone initiation was associated with lower odds of past-year suicidal ideation and past-month severe psychological distress measured in adulthood,” said lead author Jack Turban, MD, chief fellow in child and adolescent psychiatry at Stanford (Calif.) University, in an interview. “We also found better mental-health outcomes for those who started gender-affirming hormones as adolescents when compared to those who didn’t start them until they were adults.”

The use of hormone treatment and puberty blockers by transgender teens is extremely controversial. Critics say the treatments are harmful and unnecessary, and Republican politicians are trying to ban their use in some states. Last spring, Arkansas became the first state to ban the treatments. The law is on hold amid a legal challenge.

The researchers launched the study to gain more insight into the impact of hormone therapy on children. “There have been several longitudinal studies showing that mental health improves following gender-affirming medical care for transgender youth, but there has been less research looking at the relationship between when these medications are started and adult mental health outcomes,” Dr. Turban said. “This is the first study to look at various ages of initiation of gender-affirming hormones and compare outcomes between those who started gender-affirming hormones during adolescence and those who did not start them until adulthood.”

For the new study, the authors analyzed the findings of the 2015 U.S. Transgender Survey of 27,715 adults and focused on 21,598 who said they’d wanted hormone therapy (40% aged 18-24, 83% White, 35% transgender male, 41% transgender female, with the rest using other terms such as “queer” or “nonbinary” to describe themselves).

Of these subjects, 41.0% never received hormone therapy, 0.6% underwent therapy in early adolescence, 1.7% received it in late adolescence, and 56.8% got it as adults.

The researchers made various adjustments for confounders – age, partnership status, employment status, K-12 harassment, and experience of gender identity conversion efforts. Those who received hormone therapy had lower odds of past-year suicidal ideation vs. those who didn’t: adjusted odds ratio, 0.4; 95% confidence interval, 0.2-0.6; P < .0001 for therapy that occurred from age 14 to 15, aOR, 0.5; 95% CI, 0.4-0.7; P < .0001, for therapy that occurred from age 16 to 17, and aOR, 0.8; 95% CI, 0.7-0.8; P < .0001 for therapy that occurred in adulthood.

However, there was no statistically significant link between hormone therapy and past-year suicidal ideation with a plan or past-year suicide attempt.

The study also found lower rates of past-month severe psychological distress: aOR. 0.3; 95% CI, 0.2-0.4; P < .0001 for therapy from age 14 to 15, aOR, 0.3; 95% CI, 0.3-0.4; P < .0001 for therapy from age 16 to 17, and aOR, 0.6 (95% CI, 0.5-0.6; P < .0001) for therapy in adulthood.

There was no statistically significant link between hormone therapy and past-month binge drinking or lifetime illicit drug use.

“The findings indicate that clinicians caring for adolescents need to be properly trained in gender-affirming medical care, including hormone therapy, in order to help promote good mental health outcomes for transgender people. Comprehensive training in gender-affirming care is currently not part of standard medical education curricula,” said study coauthor Alex Keuroghlian, MD, MPH, director of the National LGBTQIA+ Health Education Center at the Fenway Institute and associate professor of psychiatry at Harvard Medical School, Boston, in an interview.

The study has limitations. The survey population doesn’t include anyone who committed suicide, nor does it include people who had gender dysphoria as children but didn’t go on to identify as transgender as adults. It is also retrospective. “There is a general consensus that, given the data we have so far, it would be unethical to conduct a randomized controlled trial in this space,” said study lead author Dr. Turban.

Several critics of hormone therapy in teens support a psychotherapy-based approach to gender dysphoria that considers whether other factors are at play than transgender orientation. They’ve united to attack research based on the 2015 transgender survey. In a 2021 report in Archives of Sexual Behavior, they called it “a highly skewed sample” and objected to “a conflation of ethical nonaffirmative psychotherapy with conversion therapy.”

In an interview, one of the critics – developmental psychologist and retired University of Sydney professor Dianna Kenny, PhD – said the new study’s “serious problem of recall bias” about hormone therapy in the survey is “insurmountable.” The survey, she said, also fails to explore why participants who wanted hormone therapy didn’t get it.

Dr. Kenny, who believes all hormone therapy in teens with gender dysphoria outside of clinical trials is inappropriate, also pointed out that hormone therapy has many side effects. She added that young people with gender dysphoria often “realize through a process of cognitive and psychosocial maturation that they were not ‘genuinely’ trans but suffering from other conditions that needed treatment – e.g., internalized homophobia, trauma, including sexual abuse, attention-deficit/hyperactivity disorder, autism spectrum disorder, etc.”

No specific funding is reported, although two of the authors report receiving various grants, fellowship and research funding. Dr. Turban discloses textbook royalties from Springer Nature and expert witness payments from the ACLU. Dr. Keuroghlian discloses textbook royalties from McGraw Hill. Dr. Kenny reports no disclosures.

In another salvo in the heated debate over treatment for kids who believe they’re transgender, a study published in PLoS One suggests that transgender adults who received hormone therapy as teenagers are mentally healthier in a pair of ways than those who didn’t.

The study, which only looks at transgender adults, doesn’t confirm that hormone therapy in childhood is a beneficial treatment. Still, “we found that for all age groups, access to [adolescent] gender-affirming hormone initiation was associated with lower odds of past-year suicidal ideation and past-month severe psychological distress measured in adulthood,” said lead author Jack Turban, MD, chief fellow in child and adolescent psychiatry at Stanford (Calif.) University, in an interview. “We also found better mental-health outcomes for those who started gender-affirming hormones as adolescents when compared to those who didn’t start them until they were adults.”

The use of hormone treatment and puberty blockers by transgender teens is extremely controversial. Critics say the treatments are harmful and unnecessary, and Republican politicians are trying to ban their use in some states. Last spring, Arkansas became the first state to ban the treatments. The law is on hold amid a legal challenge.

The researchers launched the study to gain more insight into the impact of hormone therapy on children. “There have been several longitudinal studies showing that mental health improves following gender-affirming medical care for transgender youth, but there has been less research looking at the relationship between when these medications are started and adult mental health outcomes,” Dr. Turban said. “This is the first study to look at various ages of initiation of gender-affirming hormones and compare outcomes between those who started gender-affirming hormones during adolescence and those who did not start them until adulthood.”

For the new study, the authors analyzed the findings of the 2015 U.S. Transgender Survey of 27,715 adults and focused on 21,598 who said they’d wanted hormone therapy (40% aged 18-24, 83% White, 35% transgender male, 41% transgender female, with the rest using other terms such as “queer” or “nonbinary” to describe themselves).

Of these subjects, 41.0% never received hormone therapy, 0.6% underwent therapy in early adolescence, 1.7% received it in late adolescence, and 56.8% got it as adults.

The researchers made various adjustments for confounders – age, partnership status, employment status, K-12 harassment, and experience of gender identity conversion efforts. Those who received hormone therapy had lower odds of past-year suicidal ideation vs. those who didn’t: adjusted odds ratio, 0.4; 95% confidence interval, 0.2-0.6; P < .0001 for therapy that occurred from age 14 to 15, aOR, 0.5; 95% CI, 0.4-0.7; P < .0001, for therapy that occurred from age 16 to 17, and aOR, 0.8; 95% CI, 0.7-0.8; P < .0001 for therapy that occurred in adulthood.

However, there was no statistically significant link between hormone therapy and past-year suicidal ideation with a plan or past-year suicide attempt.

The study also found lower rates of past-month severe psychological distress: aOR. 0.3; 95% CI, 0.2-0.4; P < .0001 for therapy from age 14 to 15, aOR, 0.3; 95% CI, 0.3-0.4; P < .0001 for therapy from age 16 to 17, and aOR, 0.6 (95% CI, 0.5-0.6; P < .0001) for therapy in adulthood.

There was no statistically significant link between hormone therapy and past-month binge drinking or lifetime illicit drug use.

“The findings indicate that clinicians caring for adolescents need to be properly trained in gender-affirming medical care, including hormone therapy, in order to help promote good mental health outcomes for transgender people. Comprehensive training in gender-affirming care is currently not part of standard medical education curricula,” said study coauthor Alex Keuroghlian, MD, MPH, director of the National LGBTQIA+ Health Education Center at the Fenway Institute and associate professor of psychiatry at Harvard Medical School, Boston, in an interview.

The study has limitations. The survey population doesn’t include anyone who committed suicide, nor does it include people who had gender dysphoria as children but didn’t go on to identify as transgender as adults. It is also retrospective. “There is a general consensus that, given the data we have so far, it would be unethical to conduct a randomized controlled trial in this space,” said study lead author Dr. Turban.

Several critics of hormone therapy in teens support a psychotherapy-based approach to gender dysphoria that considers whether other factors are at play than transgender orientation. They’ve united to attack research based on the 2015 transgender survey. In a 2021 report in Archives of Sexual Behavior, they called it “a highly skewed sample” and objected to “a conflation of ethical nonaffirmative psychotherapy with conversion therapy.”

In an interview, one of the critics – developmental psychologist and retired University of Sydney professor Dianna Kenny, PhD – said the new study’s “serious problem of recall bias” about hormone therapy in the survey is “insurmountable.” The survey, she said, also fails to explore why participants who wanted hormone therapy didn’t get it.

Dr. Kenny, who believes all hormone therapy in teens with gender dysphoria outside of clinical trials is inappropriate, also pointed out that hormone therapy has many side effects. She added that young people with gender dysphoria often “realize through a process of cognitive and psychosocial maturation that they were not ‘genuinely’ trans but suffering from other conditions that needed treatment – e.g., internalized homophobia, trauma, including sexual abuse, attention-deficit/hyperactivity disorder, autism spectrum disorder, etc.”

No specific funding is reported, although two of the authors report receiving various grants, fellowship and research funding. Dr. Turban discloses textbook royalties from Springer Nature and expert witness payments from the ACLU. Dr. Keuroghlian discloses textbook royalties from McGraw Hill. Dr. Kenny reports no disclosures.

In another salvo in the heated debate over treatment for kids who believe they’re transgender, a study published in PLoS One suggests that transgender adults who received hormone therapy as teenagers are mentally healthier in a pair of ways than those who didn’t.

The study, which only looks at transgender adults, doesn’t confirm that hormone therapy in childhood is a beneficial treatment. Still, “we found that for all age groups, access to [adolescent] gender-affirming hormone initiation was associated with lower odds of past-year suicidal ideation and past-month severe psychological distress measured in adulthood,” said lead author Jack Turban, MD, chief fellow in child and adolescent psychiatry at Stanford (Calif.) University, in an interview. “We also found better mental-health outcomes for those who started gender-affirming hormones as adolescents when compared to those who didn’t start them until they were adults.”

The use of hormone treatment and puberty blockers by transgender teens is extremely controversial. Critics say the treatments are harmful and unnecessary, and Republican politicians are trying to ban their use in some states. Last spring, Arkansas became the first state to ban the treatments. The law is on hold amid a legal challenge.

The researchers launched the study to gain more insight into the impact of hormone therapy on children. “There have been several longitudinal studies showing that mental health improves following gender-affirming medical care for transgender youth, but there has been less research looking at the relationship between when these medications are started and adult mental health outcomes,” Dr. Turban said. “This is the first study to look at various ages of initiation of gender-affirming hormones and compare outcomes between those who started gender-affirming hormones during adolescence and those who did not start them until adulthood.”

For the new study, the authors analyzed the findings of the 2015 U.S. Transgender Survey of 27,715 adults and focused on 21,598 who said they’d wanted hormone therapy (40% aged 18-24, 83% White, 35% transgender male, 41% transgender female, with the rest using other terms such as “queer” or “nonbinary” to describe themselves).

Of these subjects, 41.0% never received hormone therapy, 0.6% underwent therapy in early adolescence, 1.7% received it in late adolescence, and 56.8% got it as adults.

The researchers made various adjustments for confounders – age, partnership status, employment status, K-12 harassment, and experience of gender identity conversion efforts. Those who received hormone therapy had lower odds of past-year suicidal ideation vs. those who didn’t: adjusted odds ratio, 0.4; 95% confidence interval, 0.2-0.6; P < .0001 for therapy that occurred from age 14 to 15, aOR, 0.5; 95% CI, 0.4-0.7; P < .0001, for therapy that occurred from age 16 to 17, and aOR, 0.8; 95% CI, 0.7-0.8; P < .0001 for therapy that occurred in adulthood.

However, there was no statistically significant link between hormone therapy and past-year suicidal ideation with a plan or past-year suicide attempt.

The study also found lower rates of past-month severe psychological distress: aOR. 0.3; 95% CI, 0.2-0.4; P < .0001 for therapy from age 14 to 15, aOR, 0.3; 95% CI, 0.3-0.4; P < .0001 for therapy from age 16 to 17, and aOR, 0.6 (95% CI, 0.5-0.6; P < .0001) for therapy in adulthood.

There was no statistically significant link between hormone therapy and past-month binge drinking or lifetime illicit drug use.

“The findings indicate that clinicians caring for adolescents need to be properly trained in gender-affirming medical care, including hormone therapy, in order to help promote good mental health outcomes for transgender people. Comprehensive training in gender-affirming care is currently not part of standard medical education curricula,” said study coauthor Alex Keuroghlian, MD, MPH, director of the National LGBTQIA+ Health Education Center at the Fenway Institute and associate professor of psychiatry at Harvard Medical School, Boston, in an interview.

The study has limitations. The survey population doesn’t include anyone who committed suicide, nor does it include people who had gender dysphoria as children but didn’t go on to identify as transgender as adults. It is also retrospective. “There is a general consensus that, given the data we have so far, it would be unethical to conduct a randomized controlled trial in this space,” said study lead author Dr. Turban.

Several critics of hormone therapy in teens support a psychotherapy-based approach to gender dysphoria that considers whether other factors are at play than transgender orientation. They’ve united to attack research based on the 2015 transgender survey. In a 2021 report in Archives of Sexual Behavior, they called it “a highly skewed sample” and objected to “a conflation of ethical nonaffirmative psychotherapy with conversion therapy.”

In an interview, one of the critics – developmental psychologist and retired University of Sydney professor Dianna Kenny, PhD – said the new study’s “serious problem of recall bias” about hormone therapy in the survey is “insurmountable.” The survey, she said, also fails to explore why participants who wanted hormone therapy didn’t get it.

Dr. Kenny, who believes all hormone therapy in teens with gender dysphoria outside of clinical trials is inappropriate, also pointed out that hormone therapy has many side effects. She added that young people with gender dysphoria often “realize through a process of cognitive and psychosocial maturation that they were not ‘genuinely’ trans but suffering from other conditions that needed treatment – e.g., internalized homophobia, trauma, including sexual abuse, attention-deficit/hyperactivity disorder, autism spectrum disorder, etc.”

No specific funding is reported, although two of the authors report receiving various grants, fellowship and research funding. Dr. Turban discloses textbook royalties from Springer Nature and expert witness payments from the ACLU. Dr. Keuroghlian discloses textbook royalties from McGraw Hill. Dr. Kenny reports no disclosures.