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Prescribe Halloween safety by region, current conditions
Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. advised pediatrician Shelly Vaziri Flais, MD.
Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.
For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.
The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”
The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.
“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.
In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.
Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.
“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.
AAP-recommended Do’s and Don’ts for celebrating Halloween
DO:
- Avoid large gatherings.
- Maintain 6 feet distance.
- Wear cloth masks and wash hands often.
- Use hand sanitizer before and after visiting pumpkin patches and apple orchards.
DON’T:
- Wear painted cloth masks since paints can contain toxins that should not be breathed.
- Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
- Wear cloth mask under costume mask.
- Attend indoor parties or haunted houses.
CDC safety considerations (supplemental to state and local safety laws)
- Assess current cases and overall spread in your community before making any plans.
- Choose outdoor venues or indoor facilities that are well ventilated.
- Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
- If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
- If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
- Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
- Avoid touching your nose, eyes, and mouth.
- For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.
Suggested safe, fun activities
- Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
- Participate in socially distanced outdoor community events at local parks, zoos, etc.
- Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
- Decorate pumpkins.
- Cook a Halloween-themed meal.
- If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
- When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
- Wipe down all goodies received and consider quarantining them for a few days.
- Always wash hands before and after trick-or-treating and when handling treats.
Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. advised pediatrician Shelly Vaziri Flais, MD.
Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.
For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.
The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”
The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.
“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.
In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.
Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.
“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.
AAP-recommended Do’s and Don’ts for celebrating Halloween
DO:
- Avoid large gatherings.
- Maintain 6 feet distance.
- Wear cloth masks and wash hands often.
- Use hand sanitizer before and after visiting pumpkin patches and apple orchards.
DON’T:
- Wear painted cloth masks since paints can contain toxins that should not be breathed.
- Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
- Wear cloth mask under costume mask.
- Attend indoor parties or haunted houses.
CDC safety considerations (supplemental to state and local safety laws)
- Assess current cases and overall spread in your community before making any plans.
- Choose outdoor venues or indoor facilities that are well ventilated.
- Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
- If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
- If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
- Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
- Avoid touching your nose, eyes, and mouth.
- For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.
Suggested safe, fun activities
- Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
- Participate in socially distanced outdoor community events at local parks, zoos, etc.
- Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
- Decorate pumpkins.
- Cook a Halloween-themed meal.
- If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
- When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
- Wipe down all goodies received and consider quarantining them for a few days.
- Always wash hands before and after trick-or-treating and when handling treats.
Halloween is fast approaching and retail stores are fully stocked with costumes and candy. Physician dialog is beginning to shift from school access toward how to counsel patients and families on COVID-19 safety around Halloween. advised pediatrician Shelly Vaziri Flais, MD.
Halloween “is going to look very different this year, especially in urban and rural settings, according to Dr. Flais, who is a spokesperson for the American Academy of Pediatrics and assistant professor of clinical pediatrics at Northwestern University, Chicago. The notion that trick-or-treating automatically involves physically distancing is a misconception. Urban celebrations frequently see many people gathering on the streets, and that will be even more likely in a pandemic year when people have been separated for long periods of time.
For pediatricians advising families on COVID-19 safety measures to follow while celebrating Halloween, it’s not going to be a one-size-fits-all approach, said Dr. Flais, who practices pediatrics at Pediatric Health Associates in Naperville, Ill.
The goal for physicians across the board should be “to ensure that we aren’t so cautious that we drive folks to do things that are higher risk,” she said in an interview. “We are now 6-7 months into the pandemic and the public is growing weary of laying low, so it is important for physicians to not recommend safety measures that are too restrictive.”
The balance pediatricians will need to strike in advising their patients is tricky at best. So in dispensing advice, it is important to make sure that it has a benefit to the overall population, cautioned Dr. Flais. Activities such as hosting independently organized, heavily packed indoor gatherings where people are eating, drinking, and not wearing masks is not going to be beneficial for the masses.
“We’re all lucky that we have technology. We’ve gotten used to doing virtual hugs and activities on Zoom,” she said, adding that she has already seen some really creative ideas on social media for enjoying a COVID-conscious Halloween, including a festive candy chute created by an Ohio family that is perfect for distributing candy while minimizing physical contact.
In an AAP press release, Dr. Flais noted that “this is a good time to teach children the importance of protecting not just ourselves but each other.” How we choose to manage our safety and the safety of our children “can have a ripple effect on our family members.” It is possible to make safe, responsible choices when celebrating and still create magical memories for our children.
Francis E. Rushton Jr., MD, of the University of South Carolina, Columbia, said in an interview, “ I certainly support the AAP recommendations. Because of the way COVID-19 virus is spread, I would emphasize with my patients that the No. 1 thing to do is to enforce facial mask wearing while out trick-or-treating.
“I would also err on the side of safety if my child was showing any signs of illness and find an alternative method of celebrating Halloween that would not involve close contact with other individuals,” said Dr. Rushton, who is a member of the Pediatric News editorial advisory board.
AAP-recommended Do’s and Don’ts for celebrating Halloween
DO:
- Avoid large gatherings.
- Maintain 6 feet distance.
- Wear cloth masks and wash hands often.
- Use hand sanitizer before and after visiting pumpkin patches and apple orchards.
DON’T:
- Wear painted cloth masks since paints can contain toxins that should not be breathed.
- Use a costume mask unless it has layers of breathable fabric snugly covering mouth and nose.
- Wear cloth mask under costume mask.
- Attend indoor parties or haunted houses.
CDC safety considerations (supplemental to state and local safety laws)
- Assess current cases and overall spread in your community before making any plans.
- Choose outdoor venues or indoor facilities that are well ventilated.
- Consider the length of the event, how many are attending, where they are coming from, and how they behave before and during the event.
- If you are awaiting test results, have COVID-19 symptoms, or have been exposed to COVID-19, stay home.
- If you are at higher risk, avoid large gatherings and limit exposure to anyone you do not live with.
- Make available to others masks, 60% or greater alcohol-based hand sanitizer, and tissues.
- Avoid touching your nose, eyes, and mouth.
- For a complete set of Centers for Disease Control and Prevention COVID safety recommendations go here.
Suggested safe, fun activities
- Use Zoom and other chat programs to share costumes, play games, and watch festive movies.
- Participate in socially distanced outdoor community events at local parks, zoos, etc.
- Attend haunted forests and corn mazes. Maintain more than 6 feet of distance around screaming patrons.
- Decorate pumpkins.
- Cook a Halloween-themed meal.
- If trick-or-treating has been canceled, try a scavenger hunt in the house or yard.
- When handing out treats, wear gloves and mask. Consider prepackaging treat bags. Line up visitors 6 feet apart and discourage gatherings around entranceways.
- Wipe down all goodies received and consider quarantining them for a few days.
- Always wash hands before and after trick-or-treating and when handling treats.
Mental health risks rise with age and stage for gender-incongruent youth
Gender-incongruent youth who present for gender-affirming medical care later in adolescence have higher rates of mental health problems than their younger counterparts, based on data from a review of 300 individuals.
“Puberty is a vulnerable time for youth with gender dysphoria because distress may intensify with the development of secondary sex characteristics corresponding to the assigned rather than the experienced gender,” wrote Julia C. Sorbara, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, and colleagues.
Although gender-affirming medical care (GAMC) in the form of hormone blockers and/or gender-affirming hormones early in puberty can decrease in emotional and behavioral problems, many teens present later in puberty, and the relationship between pubertal stage at presentation for treatment and mental health has not been examined, they wrote.
In a study published in Pediatrics, the researchers reviewed data from youth with gender incongruence who were seen at a single center; 116 were younger than 15 years at presentation for GAMC and were defined as younger-presenting youth (YPY), and 184 patients aged 15 years and older were defined as older-presenting youth (OPY).
Overall, 78% of the youth reported at least one mental health problem at their initial visit. Significantly more OPY than YPY reported diagnosed depression (46% vs. 30%), self-harm (40% vs. 28%), suicidal thoughts (52% vs. 40%), suicide attempts (17% vs. 9%), and use of psychoactive medications (36% vs. 23%), all with P < .05.
In a multivariate analysis, patients in Tanner stages 4 and 5 were five times more likely to experience depressive disorders (odds ratio, 5.49) and four times as likely to experience depressive disorders (OR, 4.18) as those in earlier Tanner stages. Older age remained significantly associated with use of psychoactive medications (OR, 1.31), but not with anxiety or depression, the researchers wrote.
The YPY group were significantly younger at the age of recognizing gender incongruence, compared with the OPY group, with median ages at recognition of 5.8 years and 9 years, respectively, and younger patients came out about their gender identity at an average of 12 years, compared with 15 years for older patients.
The quantitative data are among the first to relate pubertal stage to mental health in gender-incongruent youth, “supporting clinical observations that pubertal development, menses, and erections are distressing to these youth and consistent with the beneficial role of pubertal suppression, even when used as monotherapy without gender-affirming hormones,” Dr. Sorbara and associates wrote.
The study findings were limited by several factors including the cross-sectional design and the collection of mental health data at only one time point and by the use of self-reports. However, the results suggest that “[gender-incongruent] youth who present to GAMC later in life are a particularly high-risk subset of a vulnerable population,” they noted. “Further study is required to better describe the mental health trajectories of transgender youth and determine if mental health status or age at initiation of GAMC is correlated with psychological well-being in adulthood.”
Don’t rush to puberty suppression in younger teens
To reduce the stress of puberty on gender-nonconforming youth, puberty suppression as “a reversible medical intervention” was introduced by Dutch clinicians in the early 2000s, Annelou L.C. de Vries, MD, PhD, of Amsterdam University Medical Center, wrote in an accompanying editorial.
“The aim of puberty suppression was to prevent the psychological suffering stemming from undesired physical changes when puberty starts and allowing the adolescent time to make plans regarding further transition or not,” Dr. de Vries said. “Following this rationale, younger age at the time of starting medical-affirming treatment (puberty suppression or hormones) would be expected to correlate with fewer psychological difficulties related to physical changes than older individuals,” which was confirmed in the current study.
However, clinicians should be cautious in offering puberty suppression at a younger age, in part because “despite the increased availability of gender-affirming medical interventions for younger ages in recent years, there has not been a proportional decline in older presenting youth with gender incongruence,” she said.
More data are needed on youth with postpuberty adolescent-onset transgender histories. The original Dutch studies on gender-affirming medical interventions note case histories describing “the complexities that may be associated with later-presenting transgender adolescents and describe that some eventually detransition,” Dr. de Vries explained.
Ultimately, prospective studies with longer follow-up data are needed to better inform clinicians in developing an individualized treatment plan for youth with gender incongruence, Dr. de Vries concluded.
Care barriers can include parents, access, insurance
The study authors describe the situation of gender-affirming medical care in teens perfectly, M. Brett Cooper, MD, of the University of Texas Southwestern Medical Center/Children’s Health Dallas, said in an interview.
Given a variety of factors that need further exploration, “many youth often don’t end up seeking gender-affirming medical care until puberty has progressed to near full maturity,” he said. “The findings from this study provide preliminary evidence to show that if we can identify these youth earlier in their gender journey, we might be able to impact adverse mental health outcomes in a positive way.”
Dr. Cooper said he was not surprised by the study findings. “They are similar to what I see in my clinic.
“Many of our patients often don’t present for medical care until around age 15 or older, similar to the findings of the study,” he added. “The majority of our patients have had a diagnosis of anxiety or depression at some point in their lifetime, including inpatient hospitalizations for their mental health.”
One of the most important barriers to care often can be parents or guardians, said Dr. Cooper. “Young people usually know their gender identity by about age 4-5 but parents may think that a gender-diverse identity could simply be a ‘phase.’ Other times, young people may hide their identity out of fear of a negative reaction from their parents. The distress around identity may become more pronounced once pubertal changes, such as breast and testicle development, begin to worsen their dysphoria.”
“Another barrier to care can be the inability to find a competent, gender-affirming provider,” Dr. Cooper said. “Most large United States cities have at least one gender-affirming clinic, but for those youth who grow up in smaller towns, it may be difficult to access these clinics. In addition, some clinics require a letter from a therapist stating that the young person is transgender before they can be seen for medical care. This creates an access barrier, as it may be difficult not just to find a therapist but one who has experience working with gender-diverse youth.”
Insurance coverage, including lack thereof, is yet another barrier to care for transgender youth, said Dr. Cooper. “While many insurance companies have begun to cover medications such as testosterone and estrogen for gender-affirming care, many still have exclusions on things like puberty blockers and surgical interventions.” These interventions can be lifesaving, but financially prohibitive for many families if not covered by insurance.
As for the value of early timing of gender-affirming care, Dr. Cooper agreed with the study findings that the earlier that a young person can get into medical care for their gender identity, the better chance there is to reduce the prevalence of serious mental health outcomes. “This also prevents the potential development of secondary sexual characteristics, decreasing the need for or amount of surgery in the future if desired,” he said.
“More research is needed to better understand the reasons why many youth don’t present to care until later in puberty. In addition, we need better research on interventions that are effective at reducing serious mental health events in transgender and gender diverse youth,” Dr. Cooper stated. “Another area that I would like to see researched is looking at the mental health of non-Caucasian youth. As the authors noted in their study, many clinics have a high percentage of patients presenting for care who identify as White or Caucasian, and we need to better understand why these other youth are not presenting for care.”
The study received no outside funding. Dr. Sorbara disclosed salary support from the Canadian Pediatric Endocrine Group fellowship program. Dr. de Vries had no financial conflicts to disclose. Dr. Cooper had no financial conflicts to disclose, and serves as a contributor to LGBTQ Youth Consult in Pediatric News.
SOURCES: Sorbara JC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2019-3600; de Vries ALC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2020-010611.
Gender-incongruent youth who present for gender-affirming medical care later in adolescence have higher rates of mental health problems than their younger counterparts, based on data from a review of 300 individuals.
“Puberty is a vulnerable time for youth with gender dysphoria because distress may intensify with the development of secondary sex characteristics corresponding to the assigned rather than the experienced gender,” wrote Julia C. Sorbara, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, and colleagues.
Although gender-affirming medical care (GAMC) in the form of hormone blockers and/or gender-affirming hormones early in puberty can decrease in emotional and behavioral problems, many teens present later in puberty, and the relationship between pubertal stage at presentation for treatment and mental health has not been examined, they wrote.
In a study published in Pediatrics, the researchers reviewed data from youth with gender incongruence who were seen at a single center; 116 were younger than 15 years at presentation for GAMC and were defined as younger-presenting youth (YPY), and 184 patients aged 15 years and older were defined as older-presenting youth (OPY).
Overall, 78% of the youth reported at least one mental health problem at their initial visit. Significantly more OPY than YPY reported diagnosed depression (46% vs. 30%), self-harm (40% vs. 28%), suicidal thoughts (52% vs. 40%), suicide attempts (17% vs. 9%), and use of psychoactive medications (36% vs. 23%), all with P < .05.
In a multivariate analysis, patients in Tanner stages 4 and 5 were five times more likely to experience depressive disorders (odds ratio, 5.49) and four times as likely to experience depressive disorders (OR, 4.18) as those in earlier Tanner stages. Older age remained significantly associated with use of psychoactive medications (OR, 1.31), but not with anxiety or depression, the researchers wrote.
The YPY group were significantly younger at the age of recognizing gender incongruence, compared with the OPY group, with median ages at recognition of 5.8 years and 9 years, respectively, and younger patients came out about their gender identity at an average of 12 years, compared with 15 years for older patients.
The quantitative data are among the first to relate pubertal stage to mental health in gender-incongruent youth, “supporting clinical observations that pubertal development, menses, and erections are distressing to these youth and consistent with the beneficial role of pubertal suppression, even when used as monotherapy without gender-affirming hormones,” Dr. Sorbara and associates wrote.
The study findings were limited by several factors including the cross-sectional design and the collection of mental health data at only one time point and by the use of self-reports. However, the results suggest that “[gender-incongruent] youth who present to GAMC later in life are a particularly high-risk subset of a vulnerable population,” they noted. “Further study is required to better describe the mental health trajectories of transgender youth and determine if mental health status or age at initiation of GAMC is correlated with psychological well-being in adulthood.”
Don’t rush to puberty suppression in younger teens
To reduce the stress of puberty on gender-nonconforming youth, puberty suppression as “a reversible medical intervention” was introduced by Dutch clinicians in the early 2000s, Annelou L.C. de Vries, MD, PhD, of Amsterdam University Medical Center, wrote in an accompanying editorial.
“The aim of puberty suppression was to prevent the psychological suffering stemming from undesired physical changes when puberty starts and allowing the adolescent time to make plans regarding further transition or not,” Dr. de Vries said. “Following this rationale, younger age at the time of starting medical-affirming treatment (puberty suppression or hormones) would be expected to correlate with fewer psychological difficulties related to physical changes than older individuals,” which was confirmed in the current study.
However, clinicians should be cautious in offering puberty suppression at a younger age, in part because “despite the increased availability of gender-affirming medical interventions for younger ages in recent years, there has not been a proportional decline in older presenting youth with gender incongruence,” she said.
More data are needed on youth with postpuberty adolescent-onset transgender histories. The original Dutch studies on gender-affirming medical interventions note case histories describing “the complexities that may be associated with later-presenting transgender adolescents and describe that some eventually detransition,” Dr. de Vries explained.
Ultimately, prospective studies with longer follow-up data are needed to better inform clinicians in developing an individualized treatment plan for youth with gender incongruence, Dr. de Vries concluded.
Care barriers can include parents, access, insurance
The study authors describe the situation of gender-affirming medical care in teens perfectly, M. Brett Cooper, MD, of the University of Texas Southwestern Medical Center/Children’s Health Dallas, said in an interview.
Given a variety of factors that need further exploration, “many youth often don’t end up seeking gender-affirming medical care until puberty has progressed to near full maturity,” he said. “The findings from this study provide preliminary evidence to show that if we can identify these youth earlier in their gender journey, we might be able to impact adverse mental health outcomes in a positive way.”
Dr. Cooper said he was not surprised by the study findings. “They are similar to what I see in my clinic.
“Many of our patients often don’t present for medical care until around age 15 or older, similar to the findings of the study,” he added. “The majority of our patients have had a diagnosis of anxiety or depression at some point in their lifetime, including inpatient hospitalizations for their mental health.”
One of the most important barriers to care often can be parents or guardians, said Dr. Cooper. “Young people usually know their gender identity by about age 4-5 but parents may think that a gender-diverse identity could simply be a ‘phase.’ Other times, young people may hide their identity out of fear of a negative reaction from their parents. The distress around identity may become more pronounced once pubertal changes, such as breast and testicle development, begin to worsen their dysphoria.”
“Another barrier to care can be the inability to find a competent, gender-affirming provider,” Dr. Cooper said. “Most large United States cities have at least one gender-affirming clinic, but for those youth who grow up in smaller towns, it may be difficult to access these clinics. In addition, some clinics require a letter from a therapist stating that the young person is transgender before they can be seen for medical care. This creates an access barrier, as it may be difficult not just to find a therapist but one who has experience working with gender-diverse youth.”
Insurance coverage, including lack thereof, is yet another barrier to care for transgender youth, said Dr. Cooper. “While many insurance companies have begun to cover medications such as testosterone and estrogen for gender-affirming care, many still have exclusions on things like puberty blockers and surgical interventions.” These interventions can be lifesaving, but financially prohibitive for many families if not covered by insurance.
As for the value of early timing of gender-affirming care, Dr. Cooper agreed with the study findings that the earlier that a young person can get into medical care for their gender identity, the better chance there is to reduce the prevalence of serious mental health outcomes. “This also prevents the potential development of secondary sexual characteristics, decreasing the need for or amount of surgery in the future if desired,” he said.
“More research is needed to better understand the reasons why many youth don’t present to care until later in puberty. In addition, we need better research on interventions that are effective at reducing serious mental health events in transgender and gender diverse youth,” Dr. Cooper stated. “Another area that I would like to see researched is looking at the mental health of non-Caucasian youth. As the authors noted in their study, many clinics have a high percentage of patients presenting for care who identify as White or Caucasian, and we need to better understand why these other youth are not presenting for care.”
The study received no outside funding. Dr. Sorbara disclosed salary support from the Canadian Pediatric Endocrine Group fellowship program. Dr. de Vries had no financial conflicts to disclose. Dr. Cooper had no financial conflicts to disclose, and serves as a contributor to LGBTQ Youth Consult in Pediatric News.
SOURCES: Sorbara JC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2019-3600; de Vries ALC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2020-010611.
Gender-incongruent youth who present for gender-affirming medical care later in adolescence have higher rates of mental health problems than their younger counterparts, based on data from a review of 300 individuals.
“Puberty is a vulnerable time for youth with gender dysphoria because distress may intensify with the development of secondary sex characteristics corresponding to the assigned rather than the experienced gender,” wrote Julia C. Sorbara, MD, of the University of Toronto and the Hospital for Sick Children, also in Toronto, and colleagues.
Although gender-affirming medical care (GAMC) in the form of hormone blockers and/or gender-affirming hormones early in puberty can decrease in emotional and behavioral problems, many teens present later in puberty, and the relationship between pubertal stage at presentation for treatment and mental health has not been examined, they wrote.
In a study published in Pediatrics, the researchers reviewed data from youth with gender incongruence who were seen at a single center; 116 were younger than 15 years at presentation for GAMC and were defined as younger-presenting youth (YPY), and 184 patients aged 15 years and older were defined as older-presenting youth (OPY).
Overall, 78% of the youth reported at least one mental health problem at their initial visit. Significantly more OPY than YPY reported diagnosed depression (46% vs. 30%), self-harm (40% vs. 28%), suicidal thoughts (52% vs. 40%), suicide attempts (17% vs. 9%), and use of psychoactive medications (36% vs. 23%), all with P < .05.
In a multivariate analysis, patients in Tanner stages 4 and 5 were five times more likely to experience depressive disorders (odds ratio, 5.49) and four times as likely to experience depressive disorders (OR, 4.18) as those in earlier Tanner stages. Older age remained significantly associated with use of psychoactive medications (OR, 1.31), but not with anxiety or depression, the researchers wrote.
The YPY group were significantly younger at the age of recognizing gender incongruence, compared with the OPY group, with median ages at recognition of 5.8 years and 9 years, respectively, and younger patients came out about their gender identity at an average of 12 years, compared with 15 years for older patients.
The quantitative data are among the first to relate pubertal stage to mental health in gender-incongruent youth, “supporting clinical observations that pubertal development, menses, and erections are distressing to these youth and consistent with the beneficial role of pubertal suppression, even when used as monotherapy without gender-affirming hormones,” Dr. Sorbara and associates wrote.
The study findings were limited by several factors including the cross-sectional design and the collection of mental health data at only one time point and by the use of self-reports. However, the results suggest that “[gender-incongruent] youth who present to GAMC later in life are a particularly high-risk subset of a vulnerable population,” they noted. “Further study is required to better describe the mental health trajectories of transgender youth and determine if mental health status or age at initiation of GAMC is correlated with psychological well-being in adulthood.”
Don’t rush to puberty suppression in younger teens
To reduce the stress of puberty on gender-nonconforming youth, puberty suppression as “a reversible medical intervention” was introduced by Dutch clinicians in the early 2000s, Annelou L.C. de Vries, MD, PhD, of Amsterdam University Medical Center, wrote in an accompanying editorial.
“The aim of puberty suppression was to prevent the psychological suffering stemming from undesired physical changes when puberty starts and allowing the adolescent time to make plans regarding further transition or not,” Dr. de Vries said. “Following this rationale, younger age at the time of starting medical-affirming treatment (puberty suppression or hormones) would be expected to correlate with fewer psychological difficulties related to physical changes than older individuals,” which was confirmed in the current study.
However, clinicians should be cautious in offering puberty suppression at a younger age, in part because “despite the increased availability of gender-affirming medical interventions for younger ages in recent years, there has not been a proportional decline in older presenting youth with gender incongruence,” she said.
More data are needed on youth with postpuberty adolescent-onset transgender histories. The original Dutch studies on gender-affirming medical interventions note case histories describing “the complexities that may be associated with later-presenting transgender adolescents and describe that some eventually detransition,” Dr. de Vries explained.
Ultimately, prospective studies with longer follow-up data are needed to better inform clinicians in developing an individualized treatment plan for youth with gender incongruence, Dr. de Vries concluded.
Care barriers can include parents, access, insurance
The study authors describe the situation of gender-affirming medical care in teens perfectly, M. Brett Cooper, MD, of the University of Texas Southwestern Medical Center/Children’s Health Dallas, said in an interview.
Given a variety of factors that need further exploration, “many youth often don’t end up seeking gender-affirming medical care until puberty has progressed to near full maturity,” he said. “The findings from this study provide preliminary evidence to show that if we can identify these youth earlier in their gender journey, we might be able to impact adverse mental health outcomes in a positive way.”
Dr. Cooper said he was not surprised by the study findings. “They are similar to what I see in my clinic.
“Many of our patients often don’t present for medical care until around age 15 or older, similar to the findings of the study,” he added. “The majority of our patients have had a diagnosis of anxiety or depression at some point in their lifetime, including inpatient hospitalizations for their mental health.”
One of the most important barriers to care often can be parents or guardians, said Dr. Cooper. “Young people usually know their gender identity by about age 4-5 but parents may think that a gender-diverse identity could simply be a ‘phase.’ Other times, young people may hide their identity out of fear of a negative reaction from their parents. The distress around identity may become more pronounced once pubertal changes, such as breast and testicle development, begin to worsen their dysphoria.”
“Another barrier to care can be the inability to find a competent, gender-affirming provider,” Dr. Cooper said. “Most large United States cities have at least one gender-affirming clinic, but for those youth who grow up in smaller towns, it may be difficult to access these clinics. In addition, some clinics require a letter from a therapist stating that the young person is transgender before they can be seen for medical care. This creates an access barrier, as it may be difficult not just to find a therapist but one who has experience working with gender-diverse youth.”
Insurance coverage, including lack thereof, is yet another barrier to care for transgender youth, said Dr. Cooper. “While many insurance companies have begun to cover medications such as testosterone and estrogen for gender-affirming care, many still have exclusions on things like puberty blockers and surgical interventions.” These interventions can be lifesaving, but financially prohibitive for many families if not covered by insurance.
As for the value of early timing of gender-affirming care, Dr. Cooper agreed with the study findings that the earlier that a young person can get into medical care for their gender identity, the better chance there is to reduce the prevalence of serious mental health outcomes. “This also prevents the potential development of secondary sexual characteristics, decreasing the need for or amount of surgery in the future if desired,” he said.
“More research is needed to better understand the reasons why many youth don’t present to care until later in puberty. In addition, we need better research on interventions that are effective at reducing serious mental health events in transgender and gender diverse youth,” Dr. Cooper stated. “Another area that I would like to see researched is looking at the mental health of non-Caucasian youth. As the authors noted in their study, many clinics have a high percentage of patients presenting for care who identify as White or Caucasian, and we need to better understand why these other youth are not presenting for care.”
The study received no outside funding. Dr. Sorbara disclosed salary support from the Canadian Pediatric Endocrine Group fellowship program. Dr. de Vries had no financial conflicts to disclose. Dr. Cooper had no financial conflicts to disclose, and serves as a contributor to LGBTQ Youth Consult in Pediatric News.
SOURCES: Sorbara JC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2019-3600; de Vries ALC et al. Pediatrics. 2020 Sep 21. doi: 10.1542/peds.2020-010611.
FROM PEDIATRICS
HPV vaccination remains below Healthy People goals despite increases
and vary widely across states based on data from a nested cohort study including more than 7 million children.
“Understanding regional and temporal variations in HPV vaccination coverage may help improve HPV vaccination uptake by informing public health policy,” Szu-Ta Chen, MD, of Harvard University, Boston, and colleagues wrote in Pediatrics.
To identify trends in one-dose and two-dose human papillomavirus (HPV) vaccination coverage, the researchers reviewed data from the MarketScan health care database between January 2003 and December 2017 that included 7,837,480 children and 19,843,737 person-years. The children were followed starting at age 9, when HPV vaccination could begin, and ending at one of the following: the first or second vaccination, insurance disenrollment, December 2017, or the end of the year in which they turned 17.
Overall, the proportion of 15-year-old girls and boys with at least a one-dose HPV vaccination increased from 38% and 5%, respectively, in 2011 to 57% and 51%, respectively, in 2017. The comparable proportions of girls and boys with at least a two-dose vaccination increased from 30% and 2%, respectively, in 2011 to 46% and 39%, respectively, in 2017.
Coverage lacks consistency across states
However, the vaccination coverage varied widely across states; two-dose HPV vaccination coverage ranged from 80% of girls in the District of Columbia to 15% of boys in Mississippi. In general, states with more HPV vaccine interventions had higher levels of vaccination, the researchers noted.
Legislation to improve vaccination education showed the strongest association with coverage; an 8.8% increase in coverage for girls and an 8.7% increase for boys. Pediatrician availability also was a factor associated with a 1.1% increase in coverage estimated for every pediatrician per 10,000 children.
Cumulative HPV vaccinations seen among children continuously enrolled in the study were similar to the primary analysis, the Dr. Chen and associates said. “After the initial HPV vaccination, 87% of girls and 82% of boys received a second dose by age 17 in the most recent cohorts.”
However, the HPV vaccination coverage remains below the Healthy People 2020 goal of 80% of children vaccinated by age 15 years, the researchers said. Barriers to vaccination may include a lack of routine clinical encounters in adolescents aged 11-17 years. HPV vaccination coverage was higher in urban populations, compared with rural, which may be related to a lack of providers in rural areas.
“Thus, measures beyond recommending routine vaccination at annual check-ups might be necessary to attain sufficient HPV vaccine coverage, and the optimal strategy may differ by state characteristics,” they wrote.
The study findings were limited by several factors including the use of data from only commercially-insured children and lack of data on vaccines received outside of insurance, the researchers noted.
However, the results were strengthened by the large, population-based sample, and support the need for increased efforts in HPV vaccination. “Most states will not achieve the Healthy People 2020 goal of 80% coverage with at least two HPV vaccine doses by 2020,” Dr. Chen and associates concluded.
Vaccination goals are possible with effort in the right places
The fact of below-target vaccination for HPV in the United States may be old news, but the current study offers new insights on HPV uptake, Amanda F. Dempsey, MD, PhD, of the University of Colorado at Denver, in Aurora, wrote in an accompanying editorial.
“A unique feature of this study is the ability of its researchers to study individuals over time, particularly at a national scope,” which yielded two key messages, she said.
The longitudinal examination of vaccination levels among birth cohorts showed that similar vaccination levels were achieved more quickly each year.
“For example, among the birth cohort from the year 2000, representing 17-year-olds at the time data were abstracted for the study, 40% vaccination coverage was achieved when this group was 14 years old. In contrast, among the birth cohort from the year 2005, representing 12-year-olds at the time of data abstraction, 40% vaccination coverage was reached at the age of 12,” Dr. Dempsey explained.
In addition, the study design allowed the researchers to model future vaccine coverage based on current trends, said Dr. Dempsey. “The authors estimate that, by the year 2022, the 2012 birth cohort will have reached 80% coverage for the first dose in the HPV vaccine series.”
Dr. Dempsey said she was surprised that the models did not support the hypothesis that school mandates for vaccination would increase coverage; however, there were few states in this category.
Although the findings were limited by the lack of data on uninsured children and those insured by Medicaid, the state-by-state results show that the achievement of national vaccination goals is possible, Dr. Dempsey said. In addition, the findings “warrant close consideration by policy makers and the medical community at large regarding vaccination policies and workforce,” she emphasized.The study received no outside funding. Dr. Chen had no financial conflicts to disclose. Several coauthors reported research grants to their institutions from pharmaceutical companies or being consultants to such companies. Dr. Dempsey disclosed serving on the advisory boards for Merck, Pfizer, and Sanofi Pasteur.
SOURCE: Chen S-T et al. Pediatrics. 2020 Sep 14. doi: 10.1542/peds.2019-3557.
and vary widely across states based on data from a nested cohort study including more than 7 million children.
“Understanding regional and temporal variations in HPV vaccination coverage may help improve HPV vaccination uptake by informing public health policy,” Szu-Ta Chen, MD, of Harvard University, Boston, and colleagues wrote in Pediatrics.
To identify trends in one-dose and two-dose human papillomavirus (HPV) vaccination coverage, the researchers reviewed data from the MarketScan health care database between January 2003 and December 2017 that included 7,837,480 children and 19,843,737 person-years. The children were followed starting at age 9, when HPV vaccination could begin, and ending at one of the following: the first or second vaccination, insurance disenrollment, December 2017, or the end of the year in which they turned 17.
Overall, the proportion of 15-year-old girls and boys with at least a one-dose HPV vaccination increased from 38% and 5%, respectively, in 2011 to 57% and 51%, respectively, in 2017. The comparable proportions of girls and boys with at least a two-dose vaccination increased from 30% and 2%, respectively, in 2011 to 46% and 39%, respectively, in 2017.
Coverage lacks consistency across states
However, the vaccination coverage varied widely across states; two-dose HPV vaccination coverage ranged from 80% of girls in the District of Columbia to 15% of boys in Mississippi. In general, states with more HPV vaccine interventions had higher levels of vaccination, the researchers noted.
Legislation to improve vaccination education showed the strongest association with coverage; an 8.8% increase in coverage for girls and an 8.7% increase for boys. Pediatrician availability also was a factor associated with a 1.1% increase in coverage estimated for every pediatrician per 10,000 children.
Cumulative HPV vaccinations seen among children continuously enrolled in the study were similar to the primary analysis, the Dr. Chen and associates said. “After the initial HPV vaccination, 87% of girls and 82% of boys received a second dose by age 17 in the most recent cohorts.”
However, the HPV vaccination coverage remains below the Healthy People 2020 goal of 80% of children vaccinated by age 15 years, the researchers said. Barriers to vaccination may include a lack of routine clinical encounters in adolescents aged 11-17 years. HPV vaccination coverage was higher in urban populations, compared with rural, which may be related to a lack of providers in rural areas.
“Thus, measures beyond recommending routine vaccination at annual check-ups might be necessary to attain sufficient HPV vaccine coverage, and the optimal strategy may differ by state characteristics,” they wrote.
The study findings were limited by several factors including the use of data from only commercially-insured children and lack of data on vaccines received outside of insurance, the researchers noted.
However, the results were strengthened by the large, population-based sample, and support the need for increased efforts in HPV vaccination. “Most states will not achieve the Healthy People 2020 goal of 80% coverage with at least two HPV vaccine doses by 2020,” Dr. Chen and associates concluded.
Vaccination goals are possible with effort in the right places
The fact of below-target vaccination for HPV in the United States may be old news, but the current study offers new insights on HPV uptake, Amanda F. Dempsey, MD, PhD, of the University of Colorado at Denver, in Aurora, wrote in an accompanying editorial.
“A unique feature of this study is the ability of its researchers to study individuals over time, particularly at a national scope,” which yielded two key messages, she said.
The longitudinal examination of vaccination levels among birth cohorts showed that similar vaccination levels were achieved more quickly each year.
“For example, among the birth cohort from the year 2000, representing 17-year-olds at the time data were abstracted for the study, 40% vaccination coverage was achieved when this group was 14 years old. In contrast, among the birth cohort from the year 2005, representing 12-year-olds at the time of data abstraction, 40% vaccination coverage was reached at the age of 12,” Dr. Dempsey explained.
In addition, the study design allowed the researchers to model future vaccine coverage based on current trends, said Dr. Dempsey. “The authors estimate that, by the year 2022, the 2012 birth cohort will have reached 80% coverage for the first dose in the HPV vaccine series.”
Dr. Dempsey said she was surprised that the models did not support the hypothesis that school mandates for vaccination would increase coverage; however, there were few states in this category.
Although the findings were limited by the lack of data on uninsured children and those insured by Medicaid, the state-by-state results show that the achievement of national vaccination goals is possible, Dr. Dempsey said. In addition, the findings “warrant close consideration by policy makers and the medical community at large regarding vaccination policies and workforce,” she emphasized.The study received no outside funding. Dr. Chen had no financial conflicts to disclose. Several coauthors reported research grants to their institutions from pharmaceutical companies or being consultants to such companies. Dr. Dempsey disclosed serving on the advisory boards for Merck, Pfizer, and Sanofi Pasteur.
SOURCE: Chen S-T et al. Pediatrics. 2020 Sep 14. doi: 10.1542/peds.2019-3557.
and vary widely across states based on data from a nested cohort study including more than 7 million children.
“Understanding regional and temporal variations in HPV vaccination coverage may help improve HPV vaccination uptake by informing public health policy,” Szu-Ta Chen, MD, of Harvard University, Boston, and colleagues wrote in Pediatrics.
To identify trends in one-dose and two-dose human papillomavirus (HPV) vaccination coverage, the researchers reviewed data from the MarketScan health care database between January 2003 and December 2017 that included 7,837,480 children and 19,843,737 person-years. The children were followed starting at age 9, when HPV vaccination could begin, and ending at one of the following: the first or second vaccination, insurance disenrollment, December 2017, or the end of the year in which they turned 17.
Overall, the proportion of 15-year-old girls and boys with at least a one-dose HPV vaccination increased from 38% and 5%, respectively, in 2011 to 57% and 51%, respectively, in 2017. The comparable proportions of girls and boys with at least a two-dose vaccination increased from 30% and 2%, respectively, in 2011 to 46% and 39%, respectively, in 2017.
Coverage lacks consistency across states
However, the vaccination coverage varied widely across states; two-dose HPV vaccination coverage ranged from 80% of girls in the District of Columbia to 15% of boys in Mississippi. In general, states with more HPV vaccine interventions had higher levels of vaccination, the researchers noted.
Legislation to improve vaccination education showed the strongest association with coverage; an 8.8% increase in coverage for girls and an 8.7% increase for boys. Pediatrician availability also was a factor associated with a 1.1% increase in coverage estimated for every pediatrician per 10,000 children.
Cumulative HPV vaccinations seen among children continuously enrolled in the study were similar to the primary analysis, the Dr. Chen and associates said. “After the initial HPV vaccination, 87% of girls and 82% of boys received a second dose by age 17 in the most recent cohorts.”
However, the HPV vaccination coverage remains below the Healthy People 2020 goal of 80% of children vaccinated by age 15 years, the researchers said. Barriers to vaccination may include a lack of routine clinical encounters in adolescents aged 11-17 years. HPV vaccination coverage was higher in urban populations, compared with rural, which may be related to a lack of providers in rural areas.
“Thus, measures beyond recommending routine vaccination at annual check-ups might be necessary to attain sufficient HPV vaccine coverage, and the optimal strategy may differ by state characteristics,” they wrote.
The study findings were limited by several factors including the use of data from only commercially-insured children and lack of data on vaccines received outside of insurance, the researchers noted.
However, the results were strengthened by the large, population-based sample, and support the need for increased efforts in HPV vaccination. “Most states will not achieve the Healthy People 2020 goal of 80% coverage with at least two HPV vaccine doses by 2020,” Dr. Chen and associates concluded.
Vaccination goals are possible with effort in the right places
The fact of below-target vaccination for HPV in the United States may be old news, but the current study offers new insights on HPV uptake, Amanda F. Dempsey, MD, PhD, of the University of Colorado at Denver, in Aurora, wrote in an accompanying editorial.
“A unique feature of this study is the ability of its researchers to study individuals over time, particularly at a national scope,” which yielded two key messages, she said.
The longitudinal examination of vaccination levels among birth cohorts showed that similar vaccination levels were achieved more quickly each year.
“For example, among the birth cohort from the year 2000, representing 17-year-olds at the time data were abstracted for the study, 40% vaccination coverage was achieved when this group was 14 years old. In contrast, among the birth cohort from the year 2005, representing 12-year-olds at the time of data abstraction, 40% vaccination coverage was reached at the age of 12,” Dr. Dempsey explained.
In addition, the study design allowed the researchers to model future vaccine coverage based on current trends, said Dr. Dempsey. “The authors estimate that, by the year 2022, the 2012 birth cohort will have reached 80% coverage for the first dose in the HPV vaccine series.”
Dr. Dempsey said she was surprised that the models did not support the hypothesis that school mandates for vaccination would increase coverage; however, there were few states in this category.
Although the findings were limited by the lack of data on uninsured children and those insured by Medicaid, the state-by-state results show that the achievement of national vaccination goals is possible, Dr. Dempsey said. In addition, the findings “warrant close consideration by policy makers and the medical community at large regarding vaccination policies and workforce,” she emphasized.The study received no outside funding. Dr. Chen had no financial conflicts to disclose. Several coauthors reported research grants to their institutions from pharmaceutical companies or being consultants to such companies. Dr. Dempsey disclosed serving on the advisory boards for Merck, Pfizer, and Sanofi Pasteur.
SOURCE: Chen S-T et al. Pediatrics. 2020 Sep 14. doi: 10.1542/peds.2019-3557.
FROM PEDIATRICS
Returning to competition
As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.
When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.
When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.
The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.
Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.
There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.
Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
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.” Email him at pdnews@mdedge.com.
As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.
When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.
When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.
The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.
Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.
There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.
Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
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.” Email him at pdnews@mdedge.com.
As we continue to stumble around trying to find our way out of the COVID-19 pandemic, it has become clear that the journey has been a never-ending continuum of exercises in risk/benefit assessment. The population always has sorted itself into a bell-shaped curve from those who are risk averse to those who revel in risk taking. And, of course, with a paucity of facts on which we can base our assessment of risk, the discussion often shifts to our gut feelings about the benefits.
When faced with the question of when it is time for children to return to in-person schooling, there seems to be reasonably good agreement about the benefits of face-to-face learning. The level of risk is still to be determined.
When it comes to the issue of when to return to competitive school sports, the risks are equally indeterminate but there is less agreement on the benefits. This lack of uniformity reflects a long-standing dichotomy between those parents and students with a passion for competitive sports and those who see them as nonessential. This existential tug-of-war has gone on in almost every school system I am aware of when the school budget comes up for a vote.
The debate about a return to competitive sports on a collegiate and professional level unfortunately is colored by enormous revenues from media contracts, which means that high school and middle schools can’t look to what are essentially businesses for guidance. The delay created confusion, fluctuating angst and disappointment, but the end product made some sense. Volleyball (indoor) and football were indefinitely delayed. Heavy breathing between competitors separated by a couple of feet and protected only by a flimsy net or helmet cage seems like a risk not worth taking – at least until we have more information.
Other sports were allowed to start with restrictions based on existing social distancing mandates which include no locker rooms and no fans. Some rules such as no throw-ins for soccer didn’t make sense given what we are learning about the virus. But, for the most part, the compromises should result in a chance to reap the benefits of competition for the students whose families are willing to expose them to the yet to be fully determined risks.
There has been some grumbling from parents who see the no-fans mandate as a step too far. Until we know more about the risk of group gatherings outdoors, having no fans, including parents and grandparents, makes sense. In fact, to me it is a step long overdue and a rare sliver of silver lining to the pandemic. Competitive youth sports are for the kids. They are not meant to be entertainment events. Too often children are exposed to parental pressure (voiced and unvoiced) about their “performance” on the field. Neither my younger sister nor I can remember our parents going to any of my away football games in high school or any of my lacrosse games in college. I never felt the loss.
Will I miss watching my grandchildren compete? Of course I will miss it badly. However, giving kids some space to learn and enjoy the competition for itself in an atmosphere free of parental over-involvement will be a breath of fresh air. Something we need badly during this pandemic.
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.” Email him at pdnews@mdedge.com.
Remdesivir effective, well-tolerated in final trial report
Drug beats placebo across multiple endpoints in COVID-19 patients
In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.
“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.
The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.
In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.
In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.
This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.
Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”
According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”
In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.
The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.
“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.
This point of view is shared.
“I would give this drug to anyone in the hospital infected with COVID-19 assuming there was an ample supply and no need for rationing,” said Donna E. Sweet, MD, professor of internal medicine, University of Kansas, Wichita. She noted that this study has implications for hospital and hospital staff, as well as for patients.
“This type of reduction in recovery time means a reduction in potential exposures to hospital staff, a reduced need for PPE [personal protective equipment], and it will free up beds in the ICU [intensive care unit],” said Dr. Sweet, who also serves as an editorial advisory board member for Internal Medicine News.
An infectious disease specialist at the University of Minnesota also considers remdesivir to have an important role for conserving resources that deserves emphasis.
The reduction in time to recovery “is of benefit to the health system by maintaining hospital bed capacity,” said David R. Boulware, MD, professor of medicine at the University of Minnesota, Minneapolis.
According to his reading of the available data, including those from ACTT-1, the benefit appears to be greatest in those with a moderate degree of illness, which he defined as “sick enough to be hospitalized and require oxygen, yet not severely sick [and] requiring a ventilator or [extracorporeal membrane oxygenation].”
This does not preclude a benefit in those with more severe or milder disease, but patients with mild disease “are likely to recover regardless – or despite – whatever therapy they receive,” he said.
Dr. Beigel, the principal investigator of this trial, reports no potential conflicts of interest.
SOURCE: Beigel JH et al. N Engl J Med. 2020 Oct 8. doi: 10.1056/NEJMoa2007764.
Drug beats placebo across multiple endpoints in COVID-19 patients
Drug beats placebo across multiple endpoints in COVID-19 patients
In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.
“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.
The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.
In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.
In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.
This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.
Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”
According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”
In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.
The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.
“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.
This point of view is shared.
“I would give this drug to anyone in the hospital infected with COVID-19 assuming there was an ample supply and no need for rationing,” said Donna E. Sweet, MD, professor of internal medicine, University of Kansas, Wichita. She noted that this study has implications for hospital and hospital staff, as well as for patients.
“This type of reduction in recovery time means a reduction in potential exposures to hospital staff, a reduced need for PPE [personal protective equipment], and it will free up beds in the ICU [intensive care unit],” said Dr. Sweet, who also serves as an editorial advisory board member for Internal Medicine News.
An infectious disease specialist at the University of Minnesota also considers remdesivir to have an important role for conserving resources that deserves emphasis.
The reduction in time to recovery “is of benefit to the health system by maintaining hospital bed capacity,” said David R. Boulware, MD, professor of medicine at the University of Minnesota, Minneapolis.
According to his reading of the available data, including those from ACTT-1, the benefit appears to be greatest in those with a moderate degree of illness, which he defined as “sick enough to be hospitalized and require oxygen, yet not severely sick [and] requiring a ventilator or [extracorporeal membrane oxygenation].”
This does not preclude a benefit in those with more severe or milder disease, but patients with mild disease “are likely to recover regardless – or despite – whatever therapy they receive,” he said.
Dr. Beigel, the principal investigator of this trial, reports no potential conflicts of interest.
SOURCE: Beigel JH et al. N Engl J Med. 2020 Oct 8. doi: 10.1056/NEJMoa2007764.
In May 2020, remdesivir received Food and Drug Administration approval for emergency treatment of severe COVID-19 on the basis of a preliminary report on this trial. In August 2020, the FDA expanded the indication to include all hospitalized adult and pediatric patients with suspected or laboratory-confirmed COVID-19 infection irrespective of severity.
“Our findings were consistent with the findings of the preliminary report: a 10-day course of remdesivir was superior to placebo in the treatment of hospitalized patients with COVID-19,” reported a team of investigators led by John H. Beigel, MD, of the Division of Microbiology and Infectious Diseases at the National Institute of Allergy and Infectious Diseases, in the New England Journal of Medicine.
The drug’s broadened indication was not based on the ACTT-1 trial, according to Dr. Beigel. “Other data have demonstrated that remdesivir shortens recovery in patients with lower acuity. In our study, evidence of pneumonia was an enrollment requirement,” he explained in an interview.
In the newly published final ACTT-1 data, the median time to recovery was 10 days for those on active therapy versus 15 days for those randomized to placebo. With a rate ratio of 1.29 (P less than .001), this translated to a recovery that was about one third faster.
In this final report, remdesivir’s significant advantage over placebo regarding the trial’s primary endpoint was reinforced by efficacy on multiple secondary endpoints.
This benefits on multiple secondary endpoints included a 50% greater odds ratio (OR, 1.5; 95% CI, 1.2-1.9) of significant clinical improvement by day 15 after adjustment for baseline severity, a shorter initial length of hospital stay (12 vs. 17 days) and fewer days on oxygen supplementation (13 vs. 21 days) for the subgroup of patients on oxygen at enrollment.
Although the numerically lower mortality in the remdesivir arm (6.75 vs. 11.9%) did not reach statistical significance, Dr. Beigel said, “mortality was moving in the same direction as the other key endpoints.”
According to the study investigators, the types of rates of adverse events on remdesivir, which inhibits viral replication, “were generally similar in the remdesivir and placebo groups.”
In ACTT-1, 1,062 patients were randomized to remdesivir (200 mg loading dose followed by 100 mg daily for up to 9 days) or placebo. Patients were enrolled at study sites in North America, Europe, and Asia.
The data of ACTT-1 confirm a benefit from remdesivir in hospitalized COVID-19 patients with severe disease, but Dr. Beigel said he agrees with the current FDA indication that supports treatment in any hospitalized COVID-19 patient.
“We saw bigger benefits in patients with more severe infections. The benefits are not as large in patients with mild disease, but I think remdesivir should be considered in any hospitalized patient,” Dr. Beigel said.
This point of view is shared.
“I would give this drug to anyone in the hospital infected with COVID-19 assuming there was an ample supply and no need for rationing,” said Donna E. Sweet, MD, professor of internal medicine, University of Kansas, Wichita. She noted that this study has implications for hospital and hospital staff, as well as for patients.
“This type of reduction in recovery time means a reduction in potential exposures to hospital staff, a reduced need for PPE [personal protective equipment], and it will free up beds in the ICU [intensive care unit],” said Dr. Sweet, who also serves as an editorial advisory board member for Internal Medicine News.
An infectious disease specialist at the University of Minnesota also considers remdesivir to have an important role for conserving resources that deserves emphasis.
The reduction in time to recovery “is of benefit to the health system by maintaining hospital bed capacity,” said David R. Boulware, MD, professor of medicine at the University of Minnesota, Minneapolis.
According to his reading of the available data, including those from ACTT-1, the benefit appears to be greatest in those with a moderate degree of illness, which he defined as “sick enough to be hospitalized and require oxygen, yet not severely sick [and] requiring a ventilator or [extracorporeal membrane oxygenation].”
This does not preclude a benefit in those with more severe or milder disease, but patients with mild disease “are likely to recover regardless – or despite – whatever therapy they receive,” he said.
Dr. Beigel, the principal investigator of this trial, reports no potential conflicts of interest.
SOURCE: Beigel JH et al. N Engl J Med. 2020 Oct 8. doi: 10.1056/NEJMoa2007764.
Spine fractures more common at trampoline parks, study shows
Across the United States, an explosive growth in recreational facilities boasting trampolines coincides with alarming growth in trampoline-related injuries in children, including those to the spine, according to new research.
Among youths, the risk for trampoline park–related fractures is about three times higher than for home-based trampoline fractures, said study author Serena Freiman, MD, of Washington University, St. Louis.
Recreational sports facilities with trampolines “pose a public health hazard,” Dr. Freiman said during a presentation at the virtual American Academy of Pediatrics 2020 National Conference.
“There aren’t any set regulations for these parks, so the American Society for Testing and Materials released a set of standards, but only Michigan and Arizona enforced those,” Dr. Freiman explained.
“Hopefully, since we’re showing a significant increased risk of injuries, the federal government will enforce regulations throughout the United States,” she said in an interview.
The first trampoline park in the United States opened in 2004, Dr. Freiman said. By 2018, there were more than 800 recreational facilities with trampolines across the country. This rapid growth coincided with a 45% increase in ED visits for trampoline-related injuries, from 61,509 in 2014 to more than 89,000 in 2017.
“There’s been exponential growth since their founding,” she said, “and with that we’ve also seen an exponential growth in injuries, whereas home injuries [from trampolines] remained stable during that time period.”
To assess the rates of trampoline-related injuries, Dr. Freiman and colleague analyzed data from the National Electronic Injury Surveillance System (NEISS). They included all patients whose records include a code for trampoline injury and who presented to a hospital ED between 1998 and 2017. They compared home trampoline injuries with those sustained at recreational facilities.
During the study period, more than 1.37 million patients presented to the ED for trampoline-related injuries. Of those, 125,473 occurred at recreational facilities, and 1.22 million occurred at home. Injuries at trampoline parks increased 90-fold between 2004 and 2017 (0.04 per 10,000 ED visits in 2004 to 0.9 per 10,000 in 2017), with 69% of those injuries occurring between 2012 and 2017.
Home-based trampoline injuries dropped during the study period, from 2.8 per 10,000 ED visits in 2014 to 1.6 in 2017.
Patients injured at trampoline facilities tended to present at large hospitals, Dr. Freiman noted, likely because of these parks being located in more populated regions.
The type of injury differed between locations. Severe injuries, such as spine fractures, occurred three times as often at trampoline parks than at home (2.7% vs. 0.9%; P = .016).
Internal organ injuries occurred more frequently on home-based trampolines (20.1% vs. 2.3% ; P < .001), whereas strains and sprains were more common at trampoline parks (32% vs. 51%; P < .001).
“Since home trampolines are often off the ground, I would speculate that you’re more likely to hit the edge of the trampoline or fall from it,” she said, “whereas at recreational sports facilities, there are often multiple jumpers, and you’re not falling off ― you’re falling in general or colliding with other jumpers.”
The authors noted that lower-extremity fractures occurred more often in trampoline parks (35.6% home vs. 51.7% parks; P < .0001), and upper-extremity fractures were more prevalent from home trampolines (60.2% vs. 42.5%; P < .0001). Also, a larger proportion of trampoline park injuries occurred among adolescents and young adults aged 15-34 years in comparison with home-based injuries (28.2% vs. 13.6%). No race or gender differences were noted.
Dr. Freiman noted one possible study limitation. The NEISS data only included patients tagged as being injured on trampolines, so “it may be incomplete,” she said. “Also, anyone presenting to their personal physician or urgent care centers weren’t included, so there’s likely an underestimation of cases.
“We hope people gain a better understanding of risks associated with these facilities and dive further into research and [to] identify areas that can be improved within these facilities,” Dr. Freiman added.
To drive home the importance of caution, physicians should relay data about trampoline injuries to parents and children, said Amber Hardeman, MD, MPH, MBA, of Tulane University, New Orleans.
Because most injuries at trampoline parks occur among people aged 15-34 years, Dr. Hardeman said, babysitters or parents may also “be indulging as well” when they take their young charges there to jump.
“They need to understand how to set a good example and teach kids proper safety precautions, such as not jumping too close together or maybe not doing things like splits,” she said.
Dr. Hardeman said in an interview that “there’s a lot of truth” to the study’s conclusion that recreational sports facilities with trampolines pose a public health hazard. Additional research should focus on what types of safety measures trampoline parks may be taking. Such measures could include increased padding, hiring more staff, or placing firmer limits on how many people can jump in each area at a time.
“Some centers don’t have as much padding around as others, and some allow multiple children to jump in the same area at the same time,” she said. “What exact scenarios are kids encountering more so than being on a trampoline at home?
“Trampoline centers are exciting and fun, but they are a hazard, and the fact that such an aggregate population being impacted by increasing numbers shows it’s definitely an issue right now,” Dr. Hardeman added.
Dr. Freiman and Dr. Hardeman have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Across the United States, an explosive growth in recreational facilities boasting trampolines coincides with alarming growth in trampoline-related injuries in children, including those to the spine, according to new research.
Among youths, the risk for trampoline park–related fractures is about three times higher than for home-based trampoline fractures, said study author Serena Freiman, MD, of Washington University, St. Louis.
Recreational sports facilities with trampolines “pose a public health hazard,” Dr. Freiman said during a presentation at the virtual American Academy of Pediatrics 2020 National Conference.
“There aren’t any set regulations for these parks, so the American Society for Testing and Materials released a set of standards, but only Michigan and Arizona enforced those,” Dr. Freiman explained.
“Hopefully, since we’re showing a significant increased risk of injuries, the federal government will enforce regulations throughout the United States,” she said in an interview.
The first trampoline park in the United States opened in 2004, Dr. Freiman said. By 2018, there were more than 800 recreational facilities with trampolines across the country. This rapid growth coincided with a 45% increase in ED visits for trampoline-related injuries, from 61,509 in 2014 to more than 89,000 in 2017.
“There’s been exponential growth since their founding,” she said, “and with that we’ve also seen an exponential growth in injuries, whereas home injuries [from trampolines] remained stable during that time period.”
To assess the rates of trampoline-related injuries, Dr. Freiman and colleague analyzed data from the National Electronic Injury Surveillance System (NEISS). They included all patients whose records include a code for trampoline injury and who presented to a hospital ED between 1998 and 2017. They compared home trampoline injuries with those sustained at recreational facilities.
During the study period, more than 1.37 million patients presented to the ED for trampoline-related injuries. Of those, 125,473 occurred at recreational facilities, and 1.22 million occurred at home. Injuries at trampoline parks increased 90-fold between 2004 and 2017 (0.04 per 10,000 ED visits in 2004 to 0.9 per 10,000 in 2017), with 69% of those injuries occurring between 2012 and 2017.
Home-based trampoline injuries dropped during the study period, from 2.8 per 10,000 ED visits in 2014 to 1.6 in 2017.
Patients injured at trampoline facilities tended to present at large hospitals, Dr. Freiman noted, likely because of these parks being located in more populated regions.
The type of injury differed between locations. Severe injuries, such as spine fractures, occurred three times as often at trampoline parks than at home (2.7% vs. 0.9%; P = .016).
Internal organ injuries occurred more frequently on home-based trampolines (20.1% vs. 2.3% ; P < .001), whereas strains and sprains were more common at trampoline parks (32% vs. 51%; P < .001).
“Since home trampolines are often off the ground, I would speculate that you’re more likely to hit the edge of the trampoline or fall from it,” she said, “whereas at recreational sports facilities, there are often multiple jumpers, and you’re not falling off ― you’re falling in general or colliding with other jumpers.”
The authors noted that lower-extremity fractures occurred more often in trampoline parks (35.6% home vs. 51.7% parks; P < .0001), and upper-extremity fractures were more prevalent from home trampolines (60.2% vs. 42.5%; P < .0001). Also, a larger proportion of trampoline park injuries occurred among adolescents and young adults aged 15-34 years in comparison with home-based injuries (28.2% vs. 13.6%). No race or gender differences were noted.
Dr. Freiman noted one possible study limitation. The NEISS data only included patients tagged as being injured on trampolines, so “it may be incomplete,” she said. “Also, anyone presenting to their personal physician or urgent care centers weren’t included, so there’s likely an underestimation of cases.
“We hope people gain a better understanding of risks associated with these facilities and dive further into research and [to] identify areas that can be improved within these facilities,” Dr. Freiman added.
To drive home the importance of caution, physicians should relay data about trampoline injuries to parents and children, said Amber Hardeman, MD, MPH, MBA, of Tulane University, New Orleans.
Because most injuries at trampoline parks occur among people aged 15-34 years, Dr. Hardeman said, babysitters or parents may also “be indulging as well” when they take their young charges there to jump.
“They need to understand how to set a good example and teach kids proper safety precautions, such as not jumping too close together or maybe not doing things like splits,” she said.
Dr. Hardeman said in an interview that “there’s a lot of truth” to the study’s conclusion that recreational sports facilities with trampolines pose a public health hazard. Additional research should focus on what types of safety measures trampoline parks may be taking. Such measures could include increased padding, hiring more staff, or placing firmer limits on how many people can jump in each area at a time.
“Some centers don’t have as much padding around as others, and some allow multiple children to jump in the same area at the same time,” she said. “What exact scenarios are kids encountering more so than being on a trampoline at home?
“Trampoline centers are exciting and fun, but they are a hazard, and the fact that such an aggregate population being impacted by increasing numbers shows it’s definitely an issue right now,” Dr. Hardeman added.
Dr. Freiman and Dr. Hardeman have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Across the United States, an explosive growth in recreational facilities boasting trampolines coincides with alarming growth in trampoline-related injuries in children, including those to the spine, according to new research.
Among youths, the risk for trampoline park–related fractures is about three times higher than for home-based trampoline fractures, said study author Serena Freiman, MD, of Washington University, St. Louis.
Recreational sports facilities with trampolines “pose a public health hazard,” Dr. Freiman said during a presentation at the virtual American Academy of Pediatrics 2020 National Conference.
“There aren’t any set regulations for these parks, so the American Society for Testing and Materials released a set of standards, but only Michigan and Arizona enforced those,” Dr. Freiman explained.
“Hopefully, since we’re showing a significant increased risk of injuries, the federal government will enforce regulations throughout the United States,” she said in an interview.
The first trampoline park in the United States opened in 2004, Dr. Freiman said. By 2018, there were more than 800 recreational facilities with trampolines across the country. This rapid growth coincided with a 45% increase in ED visits for trampoline-related injuries, from 61,509 in 2014 to more than 89,000 in 2017.
“There’s been exponential growth since their founding,” she said, “and with that we’ve also seen an exponential growth in injuries, whereas home injuries [from trampolines] remained stable during that time period.”
To assess the rates of trampoline-related injuries, Dr. Freiman and colleague analyzed data from the National Electronic Injury Surveillance System (NEISS). They included all patients whose records include a code for trampoline injury and who presented to a hospital ED between 1998 and 2017. They compared home trampoline injuries with those sustained at recreational facilities.
During the study period, more than 1.37 million patients presented to the ED for trampoline-related injuries. Of those, 125,473 occurred at recreational facilities, and 1.22 million occurred at home. Injuries at trampoline parks increased 90-fold between 2004 and 2017 (0.04 per 10,000 ED visits in 2004 to 0.9 per 10,000 in 2017), with 69% of those injuries occurring between 2012 and 2017.
Home-based trampoline injuries dropped during the study period, from 2.8 per 10,000 ED visits in 2014 to 1.6 in 2017.
Patients injured at trampoline facilities tended to present at large hospitals, Dr. Freiman noted, likely because of these parks being located in more populated regions.
The type of injury differed between locations. Severe injuries, such as spine fractures, occurred three times as often at trampoline parks than at home (2.7% vs. 0.9%; P = .016).
Internal organ injuries occurred more frequently on home-based trampolines (20.1% vs. 2.3% ; P < .001), whereas strains and sprains were more common at trampoline parks (32% vs. 51%; P < .001).
“Since home trampolines are often off the ground, I would speculate that you’re more likely to hit the edge of the trampoline or fall from it,” she said, “whereas at recreational sports facilities, there are often multiple jumpers, and you’re not falling off ― you’re falling in general or colliding with other jumpers.”
The authors noted that lower-extremity fractures occurred more often in trampoline parks (35.6% home vs. 51.7% parks; P < .0001), and upper-extremity fractures were more prevalent from home trampolines (60.2% vs. 42.5%; P < .0001). Also, a larger proportion of trampoline park injuries occurred among adolescents and young adults aged 15-34 years in comparison with home-based injuries (28.2% vs. 13.6%). No race or gender differences were noted.
Dr. Freiman noted one possible study limitation. The NEISS data only included patients tagged as being injured on trampolines, so “it may be incomplete,” she said. “Also, anyone presenting to their personal physician or urgent care centers weren’t included, so there’s likely an underestimation of cases.
“We hope people gain a better understanding of risks associated with these facilities and dive further into research and [to] identify areas that can be improved within these facilities,” Dr. Freiman added.
To drive home the importance of caution, physicians should relay data about trampoline injuries to parents and children, said Amber Hardeman, MD, MPH, MBA, of Tulane University, New Orleans.
Because most injuries at trampoline parks occur among people aged 15-34 years, Dr. Hardeman said, babysitters or parents may also “be indulging as well” when they take their young charges there to jump.
“They need to understand how to set a good example and teach kids proper safety precautions, such as not jumping too close together or maybe not doing things like splits,” she said.
Dr. Hardeman said in an interview that “there’s a lot of truth” to the study’s conclusion that recreational sports facilities with trampolines pose a public health hazard. Additional research should focus on what types of safety measures trampoline parks may be taking. Such measures could include increased padding, hiring more staff, or placing firmer limits on how many people can jump in each area at a time.
“Some centers don’t have as much padding around as others, and some allow multiple children to jump in the same area at the same time,” she said. “What exact scenarios are kids encountering more so than being on a trampoline at home?
“Trampoline centers are exciting and fun, but they are a hazard, and the fact that such an aggregate population being impacted by increasing numbers shows it’s definitely an issue right now,” Dr. Hardeman added.
Dr. Freiman and Dr. Hardeman have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Assault- and sports-related concussions may differ in kids
Concussions resulting from assaults and sports may not be entirely similar in children and youth, researchers report. For example, more than twice as many children who experience assault-related concussions report declines in school grades, compared with those with sports-related concussions.
The researchers also saw trends suggesting there are clinically meaningful differences between the groups in terms of longer periods before return to school, symptom resolution, and full physician clearance after injury. Patients with assault-related concussion were also less likely to be referred to specialists and to receive initial visio-vestibular testing.
The research, conducted over a 2-year period with 124 children and adolescents aged 8-18 years, stands out by focusing on lesser-understood outcomes of concussions related to assault, said study author Margaret Means, MD, of Children’s Hospital of Philadelphia.
“From my standpoint as a pediatrician and training to be a pediatric neurologist, I want to make sure I come into each patient encounter with as much understanding as I can and to treat all the associated factors adequately,” Dr. Means said.
“It’s so important to recognize that one disease process, as we categorize it, such as concussion, doesn’t mean all your patients are going to have the same needs or outcomes,” Dr. Means said in an interview. “We focus a lot on sports-related concussion, and that’s very important, but unless we recognize [that] a child who presents to the emergency department after assault could have a concussion, they are much less likely to be screened for certain concussion aspects.”
The research was presented at the virtual American Academy of Pediatrics National Conference.
Dr. Means and her colleagues undertook a retrospective chart review comparing 62 patients with assault-related concussions to the same number with sports- and recreation-related concussion between 2012 and 2014.
Patients with assault-related concussion were more likely to be Black, publicly insured, and to initially present to the emergency department. Markedly fewer patients with assault-related concussions received visio-vestibular testing at their first visit, compared with sports concussion patients (25% vs. 75%; P < .001).
Although the total number of reported physical, cognitive, emotional, and sleep symptoms didn’t differ between the groups during their recovery period, (47% vs. 20%; P = .012).
“The decline in grades in this group suggests it takes longer for children to become asymptomatic from concussion related to an assault,” Dr. Means explained. “We need to investigate that further to hopefully address that difference and help kids to not experience that decline in grades.”
Clinically meaningful but not statistically significant differences were revealed in the rate of specialist referral for those with assault-related vs. sports-related concussions (53% vs. 40%; P = .086). Patients with assault-related concussions also tended to take longer to return to school than patients with sports-related concussions (11 days vs. 8 days; P = .252); to experience symptom resolution (13.5 days vs. 11.5 days; P = .389); and to receive full physician clearance (35 days vs. 24 days; P = .332).
“With a child experiencing interpersonal assault, obviously there are a lot of different factors that need to be addressed in terms of the emotional and physical response to the trauma,” Dr. Means said. “But in terms of to-dos – and I’d love for the medical community to recognize this more readily – maybe we could develop some type of screening tool for the population experiencing assault so we might be more aware they’ve also experienced concussion.
“As a clinician, it’s important to understand research like this so you see some nuances to how each patient experiences this,” she added, “and tailor your approach to them for the best treatment and outcomes.”
Carrie Esopenko, PhD, of Rutgers University in Newark, N.J., agreed with Dr. Means that focusing on youth concussions that are not the result of sports has been largely neglected.
“We haven’t really realized concussion is occurring more on a milder scale of abusive head injuries,” said Dr. Esopenko, who conducts research on intimate partner violence but wasn’t involved in the new study.
“Head injury is the key phrase in sports right now, and I think we’re just starting to realize how prevalent the issue is in interpersonal and intimate partner violence,” Dr. Esopenko said in an interview.
“Clinicians need to do a full concussion battery on kids coming in and be aware these symptoms can be treated similarly even if they’re from a different mechanism,” she added. “It’s still the same organ impacted. These kids are still struggling, even though they’re not injured on a sports field.”
Dr. Means and Dr. Esopenko have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Concussions resulting from assaults and sports may not be entirely similar in children and youth, researchers report. For example, more than twice as many children who experience assault-related concussions report declines in school grades, compared with those with sports-related concussions.
The researchers also saw trends suggesting there are clinically meaningful differences between the groups in terms of longer periods before return to school, symptom resolution, and full physician clearance after injury. Patients with assault-related concussion were also less likely to be referred to specialists and to receive initial visio-vestibular testing.
The research, conducted over a 2-year period with 124 children and adolescents aged 8-18 years, stands out by focusing on lesser-understood outcomes of concussions related to assault, said study author Margaret Means, MD, of Children’s Hospital of Philadelphia.
“From my standpoint as a pediatrician and training to be a pediatric neurologist, I want to make sure I come into each patient encounter with as much understanding as I can and to treat all the associated factors adequately,” Dr. Means said.
“It’s so important to recognize that one disease process, as we categorize it, such as concussion, doesn’t mean all your patients are going to have the same needs or outcomes,” Dr. Means said in an interview. “We focus a lot on sports-related concussion, and that’s very important, but unless we recognize [that] a child who presents to the emergency department after assault could have a concussion, they are much less likely to be screened for certain concussion aspects.”
The research was presented at the virtual American Academy of Pediatrics National Conference.
Dr. Means and her colleagues undertook a retrospective chart review comparing 62 patients with assault-related concussions to the same number with sports- and recreation-related concussion between 2012 and 2014.
Patients with assault-related concussion were more likely to be Black, publicly insured, and to initially present to the emergency department. Markedly fewer patients with assault-related concussions received visio-vestibular testing at their first visit, compared with sports concussion patients (25% vs. 75%; P < .001).
Although the total number of reported physical, cognitive, emotional, and sleep symptoms didn’t differ between the groups during their recovery period, (47% vs. 20%; P = .012).
“The decline in grades in this group suggests it takes longer for children to become asymptomatic from concussion related to an assault,” Dr. Means explained. “We need to investigate that further to hopefully address that difference and help kids to not experience that decline in grades.”
Clinically meaningful but not statistically significant differences were revealed in the rate of specialist referral for those with assault-related vs. sports-related concussions (53% vs. 40%; P = .086). Patients with assault-related concussions also tended to take longer to return to school than patients with sports-related concussions (11 days vs. 8 days; P = .252); to experience symptom resolution (13.5 days vs. 11.5 days; P = .389); and to receive full physician clearance (35 days vs. 24 days; P = .332).
“With a child experiencing interpersonal assault, obviously there are a lot of different factors that need to be addressed in terms of the emotional and physical response to the trauma,” Dr. Means said. “But in terms of to-dos – and I’d love for the medical community to recognize this more readily – maybe we could develop some type of screening tool for the population experiencing assault so we might be more aware they’ve also experienced concussion.
“As a clinician, it’s important to understand research like this so you see some nuances to how each patient experiences this,” she added, “and tailor your approach to them for the best treatment and outcomes.”
Carrie Esopenko, PhD, of Rutgers University in Newark, N.J., agreed with Dr. Means that focusing on youth concussions that are not the result of sports has been largely neglected.
“We haven’t really realized concussion is occurring more on a milder scale of abusive head injuries,” said Dr. Esopenko, who conducts research on intimate partner violence but wasn’t involved in the new study.
“Head injury is the key phrase in sports right now, and I think we’re just starting to realize how prevalent the issue is in interpersonal and intimate partner violence,” Dr. Esopenko said in an interview.
“Clinicians need to do a full concussion battery on kids coming in and be aware these symptoms can be treated similarly even if they’re from a different mechanism,” she added. “It’s still the same organ impacted. These kids are still struggling, even though they’re not injured on a sports field.”
Dr. Means and Dr. Esopenko have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Concussions resulting from assaults and sports may not be entirely similar in children and youth, researchers report. For example, more than twice as many children who experience assault-related concussions report declines in school grades, compared with those with sports-related concussions.
The researchers also saw trends suggesting there are clinically meaningful differences between the groups in terms of longer periods before return to school, symptom resolution, and full physician clearance after injury. Patients with assault-related concussion were also less likely to be referred to specialists and to receive initial visio-vestibular testing.
The research, conducted over a 2-year period with 124 children and adolescents aged 8-18 years, stands out by focusing on lesser-understood outcomes of concussions related to assault, said study author Margaret Means, MD, of Children’s Hospital of Philadelphia.
“From my standpoint as a pediatrician and training to be a pediatric neurologist, I want to make sure I come into each patient encounter with as much understanding as I can and to treat all the associated factors adequately,” Dr. Means said.
“It’s so important to recognize that one disease process, as we categorize it, such as concussion, doesn’t mean all your patients are going to have the same needs or outcomes,” Dr. Means said in an interview. “We focus a lot on sports-related concussion, and that’s very important, but unless we recognize [that] a child who presents to the emergency department after assault could have a concussion, they are much less likely to be screened for certain concussion aspects.”
The research was presented at the virtual American Academy of Pediatrics National Conference.
Dr. Means and her colleagues undertook a retrospective chart review comparing 62 patients with assault-related concussions to the same number with sports- and recreation-related concussion between 2012 and 2014.
Patients with assault-related concussion were more likely to be Black, publicly insured, and to initially present to the emergency department. Markedly fewer patients with assault-related concussions received visio-vestibular testing at their first visit, compared with sports concussion patients (25% vs. 75%; P < .001).
Although the total number of reported physical, cognitive, emotional, and sleep symptoms didn’t differ between the groups during their recovery period, (47% vs. 20%; P = .012).
“The decline in grades in this group suggests it takes longer for children to become asymptomatic from concussion related to an assault,” Dr. Means explained. “We need to investigate that further to hopefully address that difference and help kids to not experience that decline in grades.”
Clinically meaningful but not statistically significant differences were revealed in the rate of specialist referral for those with assault-related vs. sports-related concussions (53% vs. 40%; P = .086). Patients with assault-related concussions also tended to take longer to return to school than patients with sports-related concussions (11 days vs. 8 days; P = .252); to experience symptom resolution (13.5 days vs. 11.5 days; P = .389); and to receive full physician clearance (35 days vs. 24 days; P = .332).
“With a child experiencing interpersonal assault, obviously there are a lot of different factors that need to be addressed in terms of the emotional and physical response to the trauma,” Dr. Means said. “But in terms of to-dos – and I’d love for the medical community to recognize this more readily – maybe we could develop some type of screening tool for the population experiencing assault so we might be more aware they’ve also experienced concussion.
“As a clinician, it’s important to understand research like this so you see some nuances to how each patient experiences this,” she added, “and tailor your approach to them for the best treatment and outcomes.”
Carrie Esopenko, PhD, of Rutgers University in Newark, N.J., agreed with Dr. Means that focusing on youth concussions that are not the result of sports has been largely neglected.
“We haven’t really realized concussion is occurring more on a milder scale of abusive head injuries,” said Dr. Esopenko, who conducts research on intimate partner violence but wasn’t involved in the new study.
“Head injury is the key phrase in sports right now, and I think we’re just starting to realize how prevalent the issue is in interpersonal and intimate partner violence,” Dr. Esopenko said in an interview.
“Clinicians need to do a full concussion battery on kids coming in and be aware these symptoms can be treated similarly even if they’re from a different mechanism,” she added. “It’s still the same organ impacted. These kids are still struggling, even though they’re not injured on a sports field.”
Dr. Means and Dr. Esopenko have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
CDER chief reflects on advances in rare diseases
, from helping to usher the approval of the first treatments for cystic fibrosis and multiple sclerosis during her tenure as director of the Office of Therapeutics Research and Review, to introducing the concept of risk management in the agency’s analysis of drug safety during her role as acting director of the Center for Drug Evaluation and Research (CDER).
During an online event on Oct. 9, Dr. Woodcock, who became CDER’s director in 2008, will receive a lifetime achievement award from the National Organization for Rare Disorders*. In this interview, she reflects on the CDER’s accomplishments in the field of rare diseases, from which she draws inspiration, and what it’s like to be overseeing the therapeutics component of Operation Warp Speed amid the COVID-19 pandemic.
Q: What does this lifetime achievement award from the National Organization for Rare Disorders mean to you at this stage in your career?
Dr. Woodcock: According to NORD, there are more than 7,000 rare diseases that affect an estimated 25 million Americans. More than half of those affected are children. Many of these diseases are very serious, so there is a great deal of suffering that goes on, sometimes for a lifetime. I’ve always felt that people suffering like this don’t really have a voice. I’ve always tried to push the regulatory science, the science behind evaluation, and all of the efforts we can make to help those who are trying to develop products for people suffering from these rare diseases. The science is really picking up. We’re seeing more drug approvals every year for rare disorders. Hopefully, the lives of people with rare disorders will improve and we will continue to see a trajectory of better outcomes for people.
Q: Who inspired you most early in your career as a physician? What was it about that person (or persons) that made a difference to you?
Dr. Woodcock: During my training I had the privilege to be exposed to a wide range of stellar diagnosticians and people who were good clinicians who cared about their patients. That experience modeled for me what I would like to be as a doctor.
Q: In 2017, the National Consumers League described you as “a passionate advocate for American patients and consumers, an ally to patient advocacy groups, and a fearless leader at the FDA.” In your own words, how do you describe your leadership style?
Dr. Woodcock: People always call me fearless, but I feel like I just state the facts. I care about getting technical input from everyone, but I’m not terribly concerned about people’s disapproval of my actions. I’m a leader who tries to do the right thing, the thing that will benefit patients. I try to keep them at the center of what we’re doing, who we’re regulating for. We work for the American public. As far as CDER, it’s the people who take medicine, people who administer medicine, and people who need treatments.
Q: Since joining CDER as director in 2008, what are some accomplishments you are most proud of as it relates to treatments for patients with rare diseases?
Dr. Woodcock: I undertook a transformation and modernization of the New Drugs Regulatory Program, which created offices that align interrelated disease areas, and divisions with clearer and more focused areas of expertise. These changes will bring efficiency and effectiveness. We also set up an Office of Translational Sciences. All of these actions are important. In developing drugs for rare disorders, we need more flexibility. We have a lot of critics who say, “Rare disease trials are too small.” If you look at a cardiovascular trial of 25,000 people, for example, the investigators might only have .1% of the affected population enrolled. On the other hand, a rare disease trial of 100 people might represent half of the entire population with that disease. We often get criticism because it’s more difficult to define endpoints. The diseases aren’t that well understood, and you’re going to have smaller trials because there aren’t that many people with the disease. We need to figure out how to appropriately exercise that flexibility in regulation and make sure people have access, but have a high probability of getting products that work and have been adequately tested for safely. We also started a Rare Disease Cures Accelerator, which is enrolling people online in natural history studies to see what happens to them so we can better plan studies. We have Patient-Focused Drug Development meetings as a way to gather patients’ perspectives on their conditions and available therapies to treat those conditions. That is eye-opening, because what the doctor thinks about the disease may not be what the patient thinks about the disease. The patients are the ones taking the medicine, so we need to collect their opinions. Such approaches make it easier to study rare diseases and get new treatments.
Q: How do the challenges of drug research and development in the field of rare diseases differ from those associated with more prevalent diseases?
Dr. Woodcock: There is one advantage today for people with rare diseases. That is, when there is a known genetic mutation causing a disease, RNA interference and other gene therapy approaches can be used. There are challenges, though. Patients with rare disorders often don’t have a uniform disease course. They often have a multisystem impact, so they might have things wrong with their GI tract and/or skin, so it’s difficult to know what to measure. We’re trying to remedy this by gathering better natural history information on what happens to people. That is empowering for patients as well.
Q: In what practical ways can physicians become advocates for patients and their families who are navigating life with a rare disease?
Dr. Woodcock: I advise people to get involved in the association or advocacy group for their rare disease. It’s empowering. They can share stories and information with others who have been suffering from the disease. Also, they would get information about what trials might be available. As for physicians themselves, they have a bewildering variety of jobs they’re supposed to do, so it’s hard to be good in any one of them. People with rare disease often suffer terribly because they don’t get diagnosed for 10 years even though they have classic symptoms of a particular disorder. If physicians have never seen it or never heard of it, they may not know how to treat it. It’s a huge problem.
Q: Who inspires you most in your work today?
Dr. Woodcock: The dedication of the staff at the FDA is unbelievable. When you look at responses to the Federal Employee Viewpoint Survey administered by the Office of Personnel Management, FDA workers consistently express a strong sense of mission and dedication. It’s out of the park, really. They have worked night and day during this pandemic. I’m inspired by everyone who works at the FDA and their incredible dedication to their work.
Q: In what ways do you cope with the pressure that comes with your line of work? Do you have a favorite hobby or that activity that helps keep you grounded?
Dr. Woodcock: I’m an avid gardener, so I have a garden with vegetables, fruits, and flowers, including a large orchid collection. I’m also a hiker and a physical fitness buff, so I feel like there isn’t enough time in the day for all of my hobbies. Formal hiking trails near me are very crowded now, so I’ve been hiking around my neighborhood, taking long walks and going up and down hills quickly. Last November, I went hiking in New Zealand with my daughter. We hiked the Milford Track, which is about 33 miles long. It goes from an inland lake, over a mountain pass, and to the Pacific Ocean. It was fun, with unbelievable scenery.
Q: What novel treatment developments in rare disorders are you most excited about in the next 5 years?
Dr. Woodcock: I think gene therapy will come into its own. I think that could be a game-changer for people with genetic mutations causing rare diseases, and even cancer. We’ll see. It takes the technology a long time to mature. There are also gene-directed therapies such as RNA inhibition. We’ve already approved a couple of products like that for rare diseases, including treatments for the cardiomyopathy and neuropathy associated with ATTR amyloidosis. As our knowledge of biology continues to grow, I think more of these diseases will be amenable to interventions.
Q: In May of 2020 you were asked to temporarily step aside from your post as director of CDER to work on Operation Warp Speed. Please describe what your role is in this effort to accelerate COVID-19 treatments.
Dr. Woodcock: I’m the lead on therapeutics. Operation Warp Speed is mainly focused on developing vaccines for COVID-19. In the meantime, people who don’t respond to vaccines are going to need therapeutics, such as the elderly, or those who refuse to take vaccines, or those who are immunosuppressed and can’t mount a response to a vaccine. If we can develop those therapeutics now, that would be good to get that populous vaccinated. The team identified what we thought were the five highest priority agents to work on, and we’re testing them. We have identified many more in a priority list. We have five master protocols running for different times in the disease, such as when you’re an outpatient, when you’re an inpatient, or when you’re in the ICU. The work is stressful, because we need these treatments as soon as possible, but we have a great team working on this. I feel like I’m making a contribution in this role, because I know people in industry and in the National Institutes of Health. I try to bring everyone together and get things done.
*Correction, 10/22/20: An earlier version of this article misstated the name of the National Organization for Rare Disorders.
, from helping to usher the approval of the first treatments for cystic fibrosis and multiple sclerosis during her tenure as director of the Office of Therapeutics Research and Review, to introducing the concept of risk management in the agency’s analysis of drug safety during her role as acting director of the Center for Drug Evaluation and Research (CDER).
During an online event on Oct. 9, Dr. Woodcock, who became CDER’s director in 2008, will receive a lifetime achievement award from the National Organization for Rare Disorders*. In this interview, she reflects on the CDER’s accomplishments in the field of rare diseases, from which she draws inspiration, and what it’s like to be overseeing the therapeutics component of Operation Warp Speed amid the COVID-19 pandemic.
Q: What does this lifetime achievement award from the National Organization for Rare Disorders mean to you at this stage in your career?
Dr. Woodcock: According to NORD, there are more than 7,000 rare diseases that affect an estimated 25 million Americans. More than half of those affected are children. Many of these diseases are very serious, so there is a great deal of suffering that goes on, sometimes for a lifetime. I’ve always felt that people suffering like this don’t really have a voice. I’ve always tried to push the regulatory science, the science behind evaluation, and all of the efforts we can make to help those who are trying to develop products for people suffering from these rare diseases. The science is really picking up. We’re seeing more drug approvals every year for rare disorders. Hopefully, the lives of people with rare disorders will improve and we will continue to see a trajectory of better outcomes for people.
Q: Who inspired you most early in your career as a physician? What was it about that person (or persons) that made a difference to you?
Dr. Woodcock: During my training I had the privilege to be exposed to a wide range of stellar diagnosticians and people who were good clinicians who cared about their patients. That experience modeled for me what I would like to be as a doctor.
Q: In 2017, the National Consumers League described you as “a passionate advocate for American patients and consumers, an ally to patient advocacy groups, and a fearless leader at the FDA.” In your own words, how do you describe your leadership style?
Dr. Woodcock: People always call me fearless, but I feel like I just state the facts. I care about getting technical input from everyone, but I’m not terribly concerned about people’s disapproval of my actions. I’m a leader who tries to do the right thing, the thing that will benefit patients. I try to keep them at the center of what we’re doing, who we’re regulating for. We work for the American public. As far as CDER, it’s the people who take medicine, people who administer medicine, and people who need treatments.
Q: Since joining CDER as director in 2008, what are some accomplishments you are most proud of as it relates to treatments for patients with rare diseases?
Dr. Woodcock: I undertook a transformation and modernization of the New Drugs Regulatory Program, which created offices that align interrelated disease areas, and divisions with clearer and more focused areas of expertise. These changes will bring efficiency and effectiveness. We also set up an Office of Translational Sciences. All of these actions are important. In developing drugs for rare disorders, we need more flexibility. We have a lot of critics who say, “Rare disease trials are too small.” If you look at a cardiovascular trial of 25,000 people, for example, the investigators might only have .1% of the affected population enrolled. On the other hand, a rare disease trial of 100 people might represent half of the entire population with that disease. We often get criticism because it’s more difficult to define endpoints. The diseases aren’t that well understood, and you’re going to have smaller trials because there aren’t that many people with the disease. We need to figure out how to appropriately exercise that flexibility in regulation and make sure people have access, but have a high probability of getting products that work and have been adequately tested for safely. We also started a Rare Disease Cures Accelerator, which is enrolling people online in natural history studies to see what happens to them so we can better plan studies. We have Patient-Focused Drug Development meetings as a way to gather patients’ perspectives on their conditions and available therapies to treat those conditions. That is eye-opening, because what the doctor thinks about the disease may not be what the patient thinks about the disease. The patients are the ones taking the medicine, so we need to collect their opinions. Such approaches make it easier to study rare diseases and get new treatments.
Q: How do the challenges of drug research and development in the field of rare diseases differ from those associated with more prevalent diseases?
Dr. Woodcock: There is one advantage today for people with rare diseases. That is, when there is a known genetic mutation causing a disease, RNA interference and other gene therapy approaches can be used. There are challenges, though. Patients with rare disorders often don’t have a uniform disease course. They often have a multisystem impact, so they might have things wrong with their GI tract and/or skin, so it’s difficult to know what to measure. We’re trying to remedy this by gathering better natural history information on what happens to people. That is empowering for patients as well.
Q: In what practical ways can physicians become advocates for patients and their families who are navigating life with a rare disease?
Dr. Woodcock: I advise people to get involved in the association or advocacy group for their rare disease. It’s empowering. They can share stories and information with others who have been suffering from the disease. Also, they would get information about what trials might be available. As for physicians themselves, they have a bewildering variety of jobs they’re supposed to do, so it’s hard to be good in any one of them. People with rare disease often suffer terribly because they don’t get diagnosed for 10 years even though they have classic symptoms of a particular disorder. If physicians have never seen it or never heard of it, they may not know how to treat it. It’s a huge problem.
Q: Who inspires you most in your work today?
Dr. Woodcock: The dedication of the staff at the FDA is unbelievable. When you look at responses to the Federal Employee Viewpoint Survey administered by the Office of Personnel Management, FDA workers consistently express a strong sense of mission and dedication. It’s out of the park, really. They have worked night and day during this pandemic. I’m inspired by everyone who works at the FDA and their incredible dedication to their work.
Q: In what ways do you cope with the pressure that comes with your line of work? Do you have a favorite hobby or that activity that helps keep you grounded?
Dr. Woodcock: I’m an avid gardener, so I have a garden with vegetables, fruits, and flowers, including a large orchid collection. I’m also a hiker and a physical fitness buff, so I feel like there isn’t enough time in the day for all of my hobbies. Formal hiking trails near me are very crowded now, so I’ve been hiking around my neighborhood, taking long walks and going up and down hills quickly. Last November, I went hiking in New Zealand with my daughter. We hiked the Milford Track, which is about 33 miles long. It goes from an inland lake, over a mountain pass, and to the Pacific Ocean. It was fun, with unbelievable scenery.
Q: What novel treatment developments in rare disorders are you most excited about in the next 5 years?
Dr. Woodcock: I think gene therapy will come into its own. I think that could be a game-changer for people with genetic mutations causing rare diseases, and even cancer. We’ll see. It takes the technology a long time to mature. There are also gene-directed therapies such as RNA inhibition. We’ve already approved a couple of products like that for rare diseases, including treatments for the cardiomyopathy and neuropathy associated with ATTR amyloidosis. As our knowledge of biology continues to grow, I think more of these diseases will be amenable to interventions.
Q: In May of 2020 you were asked to temporarily step aside from your post as director of CDER to work on Operation Warp Speed. Please describe what your role is in this effort to accelerate COVID-19 treatments.
Dr. Woodcock: I’m the lead on therapeutics. Operation Warp Speed is mainly focused on developing vaccines for COVID-19. In the meantime, people who don’t respond to vaccines are going to need therapeutics, such as the elderly, or those who refuse to take vaccines, or those who are immunosuppressed and can’t mount a response to a vaccine. If we can develop those therapeutics now, that would be good to get that populous vaccinated. The team identified what we thought were the five highest priority agents to work on, and we’re testing them. We have identified many more in a priority list. We have five master protocols running for different times in the disease, such as when you’re an outpatient, when you’re an inpatient, or when you’re in the ICU. The work is stressful, because we need these treatments as soon as possible, but we have a great team working on this. I feel like I’m making a contribution in this role, because I know people in industry and in the National Institutes of Health. I try to bring everyone together and get things done.
*Correction, 10/22/20: An earlier version of this article misstated the name of the National Organization for Rare Disorders.
, from helping to usher the approval of the first treatments for cystic fibrosis and multiple sclerosis during her tenure as director of the Office of Therapeutics Research and Review, to introducing the concept of risk management in the agency’s analysis of drug safety during her role as acting director of the Center for Drug Evaluation and Research (CDER).
During an online event on Oct. 9, Dr. Woodcock, who became CDER’s director in 2008, will receive a lifetime achievement award from the National Organization for Rare Disorders*. In this interview, she reflects on the CDER’s accomplishments in the field of rare diseases, from which she draws inspiration, and what it’s like to be overseeing the therapeutics component of Operation Warp Speed amid the COVID-19 pandemic.
Q: What does this lifetime achievement award from the National Organization for Rare Disorders mean to you at this stage in your career?
Dr. Woodcock: According to NORD, there are more than 7,000 rare diseases that affect an estimated 25 million Americans. More than half of those affected are children. Many of these diseases are very serious, so there is a great deal of suffering that goes on, sometimes for a lifetime. I’ve always felt that people suffering like this don’t really have a voice. I’ve always tried to push the regulatory science, the science behind evaluation, and all of the efforts we can make to help those who are trying to develop products for people suffering from these rare diseases. The science is really picking up. We’re seeing more drug approvals every year for rare disorders. Hopefully, the lives of people with rare disorders will improve and we will continue to see a trajectory of better outcomes for people.
Q: Who inspired you most early in your career as a physician? What was it about that person (or persons) that made a difference to you?
Dr. Woodcock: During my training I had the privilege to be exposed to a wide range of stellar diagnosticians and people who were good clinicians who cared about their patients. That experience modeled for me what I would like to be as a doctor.
Q: In 2017, the National Consumers League described you as “a passionate advocate for American patients and consumers, an ally to patient advocacy groups, and a fearless leader at the FDA.” In your own words, how do you describe your leadership style?
Dr. Woodcock: People always call me fearless, but I feel like I just state the facts. I care about getting technical input from everyone, but I’m not terribly concerned about people’s disapproval of my actions. I’m a leader who tries to do the right thing, the thing that will benefit patients. I try to keep them at the center of what we’re doing, who we’re regulating for. We work for the American public. As far as CDER, it’s the people who take medicine, people who administer medicine, and people who need treatments.
Q: Since joining CDER as director in 2008, what are some accomplishments you are most proud of as it relates to treatments for patients with rare diseases?
Dr. Woodcock: I undertook a transformation and modernization of the New Drugs Regulatory Program, which created offices that align interrelated disease areas, and divisions with clearer and more focused areas of expertise. These changes will bring efficiency and effectiveness. We also set up an Office of Translational Sciences. All of these actions are important. In developing drugs for rare disorders, we need more flexibility. We have a lot of critics who say, “Rare disease trials are too small.” If you look at a cardiovascular trial of 25,000 people, for example, the investigators might only have .1% of the affected population enrolled. On the other hand, a rare disease trial of 100 people might represent half of the entire population with that disease. We often get criticism because it’s more difficult to define endpoints. The diseases aren’t that well understood, and you’re going to have smaller trials because there aren’t that many people with the disease. We need to figure out how to appropriately exercise that flexibility in regulation and make sure people have access, but have a high probability of getting products that work and have been adequately tested for safely. We also started a Rare Disease Cures Accelerator, which is enrolling people online in natural history studies to see what happens to them so we can better plan studies. We have Patient-Focused Drug Development meetings as a way to gather patients’ perspectives on their conditions and available therapies to treat those conditions. That is eye-opening, because what the doctor thinks about the disease may not be what the patient thinks about the disease. The patients are the ones taking the medicine, so we need to collect their opinions. Such approaches make it easier to study rare diseases and get new treatments.
Q: How do the challenges of drug research and development in the field of rare diseases differ from those associated with more prevalent diseases?
Dr. Woodcock: There is one advantage today for people with rare diseases. That is, when there is a known genetic mutation causing a disease, RNA interference and other gene therapy approaches can be used. There are challenges, though. Patients with rare disorders often don’t have a uniform disease course. They often have a multisystem impact, so they might have things wrong with their GI tract and/or skin, so it’s difficult to know what to measure. We’re trying to remedy this by gathering better natural history information on what happens to people. That is empowering for patients as well.
Q: In what practical ways can physicians become advocates for patients and their families who are navigating life with a rare disease?
Dr. Woodcock: I advise people to get involved in the association or advocacy group for their rare disease. It’s empowering. They can share stories and information with others who have been suffering from the disease. Also, they would get information about what trials might be available. As for physicians themselves, they have a bewildering variety of jobs they’re supposed to do, so it’s hard to be good in any one of them. People with rare disease often suffer terribly because they don’t get diagnosed for 10 years even though they have classic symptoms of a particular disorder. If physicians have never seen it or never heard of it, they may not know how to treat it. It’s a huge problem.
Q: Who inspires you most in your work today?
Dr. Woodcock: The dedication of the staff at the FDA is unbelievable. When you look at responses to the Federal Employee Viewpoint Survey administered by the Office of Personnel Management, FDA workers consistently express a strong sense of mission and dedication. It’s out of the park, really. They have worked night and day during this pandemic. I’m inspired by everyone who works at the FDA and their incredible dedication to their work.
Q: In what ways do you cope with the pressure that comes with your line of work? Do you have a favorite hobby or that activity that helps keep you grounded?
Dr. Woodcock: I’m an avid gardener, so I have a garden with vegetables, fruits, and flowers, including a large orchid collection. I’m also a hiker and a physical fitness buff, so I feel like there isn’t enough time in the day for all of my hobbies. Formal hiking trails near me are very crowded now, so I’ve been hiking around my neighborhood, taking long walks and going up and down hills quickly. Last November, I went hiking in New Zealand with my daughter. We hiked the Milford Track, which is about 33 miles long. It goes from an inland lake, over a mountain pass, and to the Pacific Ocean. It was fun, with unbelievable scenery.
Q: What novel treatment developments in rare disorders are you most excited about in the next 5 years?
Dr. Woodcock: I think gene therapy will come into its own. I think that could be a game-changer for people with genetic mutations causing rare diseases, and even cancer. We’ll see. It takes the technology a long time to mature. There are also gene-directed therapies such as RNA inhibition. We’ve already approved a couple of products like that for rare diseases, including treatments for the cardiomyopathy and neuropathy associated with ATTR amyloidosis. As our knowledge of biology continues to grow, I think more of these diseases will be amenable to interventions.
Q: In May of 2020 you were asked to temporarily step aside from your post as director of CDER to work on Operation Warp Speed. Please describe what your role is in this effort to accelerate COVID-19 treatments.
Dr. Woodcock: I’m the lead on therapeutics. Operation Warp Speed is mainly focused on developing vaccines for COVID-19. In the meantime, people who don’t respond to vaccines are going to need therapeutics, such as the elderly, or those who refuse to take vaccines, or those who are immunosuppressed and can’t mount a response to a vaccine. If we can develop those therapeutics now, that would be good to get that populous vaccinated. The team identified what we thought were the five highest priority agents to work on, and we’re testing them. We have identified many more in a priority list. We have five master protocols running for different times in the disease, such as when you’re an outpatient, when you’re an inpatient, or when you’re in the ICU. The work is stressful, because we need these treatments as soon as possible, but we have a great team working on this. I feel like I’m making a contribution in this role, because I know people in industry and in the National Institutes of Health. I try to bring everyone together and get things done.
*Correction, 10/22/20: An earlier version of this article misstated the name of the National Organization for Rare Disorders.
Is depression contagious?
I previously wrote a column in which I discussed the possible relationship between television viewing and the risk of developing depression. In that column I mentioned that, while there is widespread suspicion that depression may have a genetic component, I was unaware of any strong evidence that this is the case. This week I encountered another study in the American Journal of Psychiatry that suggests that the environment in which a child is raised can play a significant role in whether he or she will develop depression.
All of the children in the study had been born to families in which at least one biological parent had been diagnosed with major depression. There were nearly 700 full sibships and 2,600 half sibships studied. The researchers found that children who had been adopted away and raised in families that had been selected for having high-quality childrearing standards were significantly less likely to develop depression (23% for full siblings, 19% for half siblings) than their siblings who had remained in the home of their biological parents. It is interesting that this protective effect of the adoptive home “disappeared when an adoptive parent or stepsibling had major depression or the adoptive home was disrupted by parental death or divorce.”
It is unlikely that this study ever will be replicated because of the unique manner in which these Swedish adoptions were managed and recorded. However, and probably even more of an influence than genetics.
Are you surprised by the results of this study? Or, like me, have you always suspected that a child growing up in a household with a depressed, missing, or divorced parent was at increased risk of becoming depressed, particularly they had a genetic vulnerability? How will you change your approach to families with a depressed parent or ones that are navigating through the stormy waters of even an amicable divorce? Will you be more diligent about screening children in these families for depression? Should the agencies that are responsible for managing adoption and foster home placement include this new information in their screening criteria?
It would be very interesting to see a similar study performed using families in which a biological parent had been diagnosed with anxiety or an attention-deficit disorder. Could it mean that we should be considering depression and these conditions as contagious disorders? The results from such studies might help provide clarity to why we are seeing more children with mental health complaints. They might explain why pediatricians are seeing an increasing frequency of mental health complaints in our offices. It may not be too far-fetched to use epidemiologic terms when we are talking about depression, anxiety, and ADHD. Should we be considering these conditions to be contagious under certain circumstances?
Since the human genome has been sequenced I sense that our attention has become overfocused on using what we are learning about our DNA to explain what makes us sick. It may be time to swing the pendulum back a few degrees and remind ourselves of the power of the family environment.
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.” Email him at pdnews@mdedge.com.
I previously wrote a column in which I discussed the possible relationship between television viewing and the risk of developing depression. In that column I mentioned that, while there is widespread suspicion that depression may have a genetic component, I was unaware of any strong evidence that this is the case. This week I encountered another study in the American Journal of Psychiatry that suggests that the environment in which a child is raised can play a significant role in whether he or she will develop depression.
All of the children in the study had been born to families in which at least one biological parent had been diagnosed with major depression. There were nearly 700 full sibships and 2,600 half sibships studied. The researchers found that children who had been adopted away and raised in families that had been selected for having high-quality childrearing standards were significantly less likely to develop depression (23% for full siblings, 19% for half siblings) than their siblings who had remained in the home of their biological parents. It is interesting that this protective effect of the adoptive home “disappeared when an adoptive parent or stepsibling had major depression or the adoptive home was disrupted by parental death or divorce.”
It is unlikely that this study ever will be replicated because of the unique manner in which these Swedish adoptions were managed and recorded. However, and probably even more of an influence than genetics.
Are you surprised by the results of this study? Or, like me, have you always suspected that a child growing up in a household with a depressed, missing, or divorced parent was at increased risk of becoming depressed, particularly they had a genetic vulnerability? How will you change your approach to families with a depressed parent or ones that are navigating through the stormy waters of even an amicable divorce? Will you be more diligent about screening children in these families for depression? Should the agencies that are responsible for managing adoption and foster home placement include this new information in their screening criteria?
It would be very interesting to see a similar study performed using families in which a biological parent had been diagnosed with anxiety or an attention-deficit disorder. Could it mean that we should be considering depression and these conditions as contagious disorders? The results from such studies might help provide clarity to why we are seeing more children with mental health complaints. They might explain why pediatricians are seeing an increasing frequency of mental health complaints in our offices. It may not be too far-fetched to use epidemiologic terms when we are talking about depression, anxiety, and ADHD. Should we be considering these conditions to be contagious under certain circumstances?
Since the human genome has been sequenced I sense that our attention has become overfocused on using what we are learning about our DNA to explain what makes us sick. It may be time to swing the pendulum back a few degrees and remind ourselves of the power of the family environment.
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.” Email him at pdnews@mdedge.com.
I previously wrote a column in which I discussed the possible relationship between television viewing and the risk of developing depression. In that column I mentioned that, while there is widespread suspicion that depression may have a genetic component, I was unaware of any strong evidence that this is the case. This week I encountered another study in the American Journal of Psychiatry that suggests that the environment in which a child is raised can play a significant role in whether he or she will develop depression.
All of the children in the study had been born to families in which at least one biological parent had been diagnosed with major depression. There were nearly 700 full sibships and 2,600 half sibships studied. The researchers found that children who had been adopted away and raised in families that had been selected for having high-quality childrearing standards were significantly less likely to develop depression (23% for full siblings, 19% for half siblings) than their siblings who had remained in the home of their biological parents. It is interesting that this protective effect of the adoptive home “disappeared when an adoptive parent or stepsibling had major depression or the adoptive home was disrupted by parental death or divorce.”
It is unlikely that this study ever will be replicated because of the unique manner in which these Swedish adoptions were managed and recorded. However, and probably even more of an influence than genetics.
Are you surprised by the results of this study? Or, like me, have you always suspected that a child growing up in a household with a depressed, missing, or divorced parent was at increased risk of becoming depressed, particularly they had a genetic vulnerability? How will you change your approach to families with a depressed parent or ones that are navigating through the stormy waters of even an amicable divorce? Will you be more diligent about screening children in these families for depression? Should the agencies that are responsible for managing adoption and foster home placement include this new information in their screening criteria?
It would be very interesting to see a similar study performed using families in which a biological parent had been diagnosed with anxiety or an attention-deficit disorder. Could it mean that we should be considering depression and these conditions as contagious disorders? The results from such studies might help provide clarity to why we are seeing more children with mental health complaints. They might explain why pediatricians are seeing an increasing frequency of mental health complaints in our offices. It may not be too far-fetched to use epidemiologic terms when we are talking about depression, anxiety, and ADHD. Should we be considering these conditions to be contagious under certain circumstances?
Since the human genome has been sequenced I sense that our attention has become overfocused on using what we are learning about our DNA to explain what makes us sick. It may be time to swing the pendulum back a few degrees and remind ourselves of the power of the family environment.
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.” Email him at pdnews@mdedge.com.
More data on impact of corticosteroids on COVID-19 mortality in patients with COPD
, a study of almost 1 million individuals in the United Kingdom has shown.
Patients with chronic obstructive pulmonary disease or asthma who used ICS on a regular basis were more likely to die from COVID-19 than COPD or asthma patients who were prescribed non-ICS therapies, reported co-lead author Anna Schultze, PhD, of London School of Hygiene & Tropical Medicine and colleagues.
Of note, the increased risk of death among ICS users likely stemmed from greater severity of preexisting chronic respiratory conditions, instead of directly from ICS usage, which has little apparent impact on COVID-19 mortality, the investigators wrote in Lancet Respiratory Medicine.
These findings conflict with a hypothesis proposed early in the pandemic: that ICS may protect individuals from SARS-CoV-2 infection and poor outcomes with COVID-19.
According to Megan Conroy, MD, of the department of internal medicine at the Ohio State University Wexner Medical Center, Columbus, this hypothesis was based on some unexpected epidemiological findings.
“In general, we tend to think people with underlying lung disease – like COPD or asthma – to be at higher risk for severe forms of lower respiratory tract infections,” Dr. Conroy said. “Somewhat surprisingly, early data in the pandemic showed patients with COPD and asthma [were] underrepresented [among patients with COVID] when compared to the prevalence of these diseases in the population.”
This raised the possibility of an incidental protective effect from regular ICS therapy, which “had some strong theoretic pathophysiologic basis,” Dr. Conroy said, referring to research that demonstrated ICS-mediated downregulation of SARS-CoV-2 entry receptors ACE2 and TMPRSS2.
Dr. Schultze and colleagues noted that investigators for two ongoing randomized controlled trials (NCT04331054, NCT04330586) are studying ICS as an intervention for COVID-19; but neither trial includes individuals already taking ICS for chronic respiratory disease.
The present observational study therefore aimed to assess mortality risk within this population. Data were drawn from electronic health records and a U.K. national mortality database, with follow-up ranging from March 1 to May 6, 2020. Eligibility required a relevant prescription within 4 months of first follow-up. In the COPD group, patients were prescribed a long-acting beta agonist plus a long-acting muscarinic antagonist (LABA–LAMA), LABA alone, LABA plus ICS, LABA–LAMA plus ICS, or ICS alone (if prescribed LABA within 4 months).
In the asthma group, patients received low/medium-dose ICS, high-dose ICS, or a short-acting beta agonist (SABA) alone. Patients with COPD were at least 35 years of age, while those with asthma were 18 years or older. Hazard ratios were adjusted for a variety of covariates, including respiratory disease–exacerbation history, age, sex, body mass index, hypertension, diabetes, and others.
These eligibility criteria returned 148,557 patients with COPD and 818,490 with asthma.
Patients with COPD who were prescribed ICS plus LABA-LAMA or ICS plus LABA had an increased risk of COVID-19-related death, compared with those who did not receive ICS (adjusted hazard ratio, 1.39; 95% confidence interval, 1.10-1.76). Separate analyses of patients who received a triple combination (LABA–LAMA plus ICS) versus those who took a dual combination (LABA plus ICS) showed that triple-combination therapy was significantly associated with increased COVID-19-related mortality (aHR, 1.43; 95% CI, 1.12-1.83), while dual-combination therapy was less so (aHR, 1.29; 95% CI, 0.96-1.74). Non–COVID-19–related mortality was significantly increased for all COPD patients who were prescribed ICS, with or without adjustment for covariates.
Asthma patients prescribed high-dose ICS instead of SABA alone had a slightly greater risk of COVID-19–related death, based on an adjusted hazard ratio of 1.55 (95% CI, 1.10-2.18). Those with asthma who received low/medium–dose ICS demonstrated a slight trend toward increased mortality risk, but this was not significant (aHR, 1.14; 95% CI, 0.85-1.54). ICS usage in the asthma group was not linked with a significant increase in non–COVID-19–related death.
“In summary, we found no evidence of a beneficial effect of regular ICS use among people with COPD and asthma on COVID-19–related mortality,” the investigators concluded.
In agreement with the investigators, Dr. Conroy said that the increased mortality rate among ICS users should not be misconstrued as a medication-related risk.
“While the study found that those with COPD or asthma taking ICS and high-dose ICS were at an increased risk of death, this could easily be explained by the likelihood that those are the patients who are more likely to have more severe underlying lung disease,” Dr. Conroy said. “While this observational study did attempt to control for exacerbation history, the ability to do so by electronic health records data is certainly imperfect.”
With this in mind, patients with chronic respiratory disease should be encouraged to adhere to their usual treatment regimen, Dr. Conroy added.
“There isn’t evidence to increase or decrease medications just because of the pandemic,” she said. “A patient with asthma or COPD should continue to take the medications that are needed to achieve good control of their lung disease.”
The study was funded by the U.K. Medical Research Council. The investigators reported additional relationships with the Wellcome Trust, the Good Thinking Foundation, the Laura and John Arnold Foundation, and others. Dr. Conroy reported no conflicts of interest.
SOURCE: Schultze A et al. Lancet Respir Med. 2020 Sep 24. doi: 10.1016/ S2213-2600(20)30415-X.
, a study of almost 1 million individuals in the United Kingdom has shown.
Patients with chronic obstructive pulmonary disease or asthma who used ICS on a regular basis were more likely to die from COVID-19 than COPD or asthma patients who were prescribed non-ICS therapies, reported co-lead author Anna Schultze, PhD, of London School of Hygiene & Tropical Medicine and colleagues.
Of note, the increased risk of death among ICS users likely stemmed from greater severity of preexisting chronic respiratory conditions, instead of directly from ICS usage, which has little apparent impact on COVID-19 mortality, the investigators wrote in Lancet Respiratory Medicine.
These findings conflict with a hypothesis proposed early in the pandemic: that ICS may protect individuals from SARS-CoV-2 infection and poor outcomes with COVID-19.
According to Megan Conroy, MD, of the department of internal medicine at the Ohio State University Wexner Medical Center, Columbus, this hypothesis was based on some unexpected epidemiological findings.
“In general, we tend to think people with underlying lung disease – like COPD or asthma – to be at higher risk for severe forms of lower respiratory tract infections,” Dr. Conroy said. “Somewhat surprisingly, early data in the pandemic showed patients with COPD and asthma [were] underrepresented [among patients with COVID] when compared to the prevalence of these diseases in the population.”
This raised the possibility of an incidental protective effect from regular ICS therapy, which “had some strong theoretic pathophysiologic basis,” Dr. Conroy said, referring to research that demonstrated ICS-mediated downregulation of SARS-CoV-2 entry receptors ACE2 and TMPRSS2.
Dr. Schultze and colleagues noted that investigators for two ongoing randomized controlled trials (NCT04331054, NCT04330586) are studying ICS as an intervention for COVID-19; but neither trial includes individuals already taking ICS for chronic respiratory disease.
The present observational study therefore aimed to assess mortality risk within this population. Data were drawn from electronic health records and a U.K. national mortality database, with follow-up ranging from March 1 to May 6, 2020. Eligibility required a relevant prescription within 4 months of first follow-up. In the COPD group, patients were prescribed a long-acting beta agonist plus a long-acting muscarinic antagonist (LABA–LAMA), LABA alone, LABA plus ICS, LABA–LAMA plus ICS, or ICS alone (if prescribed LABA within 4 months).
In the asthma group, patients received low/medium-dose ICS, high-dose ICS, or a short-acting beta agonist (SABA) alone. Patients with COPD were at least 35 years of age, while those with asthma were 18 years or older. Hazard ratios were adjusted for a variety of covariates, including respiratory disease–exacerbation history, age, sex, body mass index, hypertension, diabetes, and others.
These eligibility criteria returned 148,557 patients with COPD and 818,490 with asthma.
Patients with COPD who were prescribed ICS plus LABA-LAMA or ICS plus LABA had an increased risk of COVID-19-related death, compared with those who did not receive ICS (adjusted hazard ratio, 1.39; 95% confidence interval, 1.10-1.76). Separate analyses of patients who received a triple combination (LABA–LAMA plus ICS) versus those who took a dual combination (LABA plus ICS) showed that triple-combination therapy was significantly associated with increased COVID-19-related mortality (aHR, 1.43; 95% CI, 1.12-1.83), while dual-combination therapy was less so (aHR, 1.29; 95% CI, 0.96-1.74). Non–COVID-19–related mortality was significantly increased for all COPD patients who were prescribed ICS, with or without adjustment for covariates.
Asthma patients prescribed high-dose ICS instead of SABA alone had a slightly greater risk of COVID-19–related death, based on an adjusted hazard ratio of 1.55 (95% CI, 1.10-2.18). Those with asthma who received low/medium–dose ICS demonstrated a slight trend toward increased mortality risk, but this was not significant (aHR, 1.14; 95% CI, 0.85-1.54). ICS usage in the asthma group was not linked with a significant increase in non–COVID-19–related death.
“In summary, we found no evidence of a beneficial effect of regular ICS use among people with COPD and asthma on COVID-19–related mortality,” the investigators concluded.
In agreement with the investigators, Dr. Conroy said that the increased mortality rate among ICS users should not be misconstrued as a medication-related risk.
“While the study found that those with COPD or asthma taking ICS and high-dose ICS were at an increased risk of death, this could easily be explained by the likelihood that those are the patients who are more likely to have more severe underlying lung disease,” Dr. Conroy said. “While this observational study did attempt to control for exacerbation history, the ability to do so by electronic health records data is certainly imperfect.”
With this in mind, patients with chronic respiratory disease should be encouraged to adhere to their usual treatment regimen, Dr. Conroy added.
“There isn’t evidence to increase or decrease medications just because of the pandemic,” she said. “A patient with asthma or COPD should continue to take the medications that are needed to achieve good control of their lung disease.”
The study was funded by the U.K. Medical Research Council. The investigators reported additional relationships with the Wellcome Trust, the Good Thinking Foundation, the Laura and John Arnold Foundation, and others. Dr. Conroy reported no conflicts of interest.
SOURCE: Schultze A et al. Lancet Respir Med. 2020 Sep 24. doi: 10.1016/ S2213-2600(20)30415-X.
, a study of almost 1 million individuals in the United Kingdom has shown.
Patients with chronic obstructive pulmonary disease or asthma who used ICS on a regular basis were more likely to die from COVID-19 than COPD or asthma patients who were prescribed non-ICS therapies, reported co-lead author Anna Schultze, PhD, of London School of Hygiene & Tropical Medicine and colleagues.
Of note, the increased risk of death among ICS users likely stemmed from greater severity of preexisting chronic respiratory conditions, instead of directly from ICS usage, which has little apparent impact on COVID-19 mortality, the investigators wrote in Lancet Respiratory Medicine.
These findings conflict with a hypothesis proposed early in the pandemic: that ICS may protect individuals from SARS-CoV-2 infection and poor outcomes with COVID-19.
According to Megan Conroy, MD, of the department of internal medicine at the Ohio State University Wexner Medical Center, Columbus, this hypothesis was based on some unexpected epidemiological findings.
“In general, we tend to think people with underlying lung disease – like COPD or asthma – to be at higher risk for severe forms of lower respiratory tract infections,” Dr. Conroy said. “Somewhat surprisingly, early data in the pandemic showed patients with COPD and asthma [were] underrepresented [among patients with COVID] when compared to the prevalence of these diseases in the population.”
This raised the possibility of an incidental protective effect from regular ICS therapy, which “had some strong theoretic pathophysiologic basis,” Dr. Conroy said, referring to research that demonstrated ICS-mediated downregulation of SARS-CoV-2 entry receptors ACE2 and TMPRSS2.
Dr. Schultze and colleagues noted that investigators for two ongoing randomized controlled trials (NCT04331054, NCT04330586) are studying ICS as an intervention for COVID-19; but neither trial includes individuals already taking ICS for chronic respiratory disease.
The present observational study therefore aimed to assess mortality risk within this population. Data were drawn from electronic health records and a U.K. national mortality database, with follow-up ranging from March 1 to May 6, 2020. Eligibility required a relevant prescription within 4 months of first follow-up. In the COPD group, patients were prescribed a long-acting beta agonist plus a long-acting muscarinic antagonist (LABA–LAMA), LABA alone, LABA plus ICS, LABA–LAMA plus ICS, or ICS alone (if prescribed LABA within 4 months).
In the asthma group, patients received low/medium-dose ICS, high-dose ICS, or a short-acting beta agonist (SABA) alone. Patients with COPD were at least 35 years of age, while those with asthma were 18 years or older. Hazard ratios were adjusted for a variety of covariates, including respiratory disease–exacerbation history, age, sex, body mass index, hypertension, diabetes, and others.
These eligibility criteria returned 148,557 patients with COPD and 818,490 with asthma.
Patients with COPD who were prescribed ICS plus LABA-LAMA or ICS plus LABA had an increased risk of COVID-19-related death, compared with those who did not receive ICS (adjusted hazard ratio, 1.39; 95% confidence interval, 1.10-1.76). Separate analyses of patients who received a triple combination (LABA–LAMA plus ICS) versus those who took a dual combination (LABA plus ICS) showed that triple-combination therapy was significantly associated with increased COVID-19-related mortality (aHR, 1.43; 95% CI, 1.12-1.83), while dual-combination therapy was less so (aHR, 1.29; 95% CI, 0.96-1.74). Non–COVID-19–related mortality was significantly increased for all COPD patients who were prescribed ICS, with or without adjustment for covariates.
Asthma patients prescribed high-dose ICS instead of SABA alone had a slightly greater risk of COVID-19–related death, based on an adjusted hazard ratio of 1.55 (95% CI, 1.10-2.18). Those with asthma who received low/medium–dose ICS demonstrated a slight trend toward increased mortality risk, but this was not significant (aHR, 1.14; 95% CI, 0.85-1.54). ICS usage in the asthma group was not linked with a significant increase in non–COVID-19–related death.
“In summary, we found no evidence of a beneficial effect of regular ICS use among people with COPD and asthma on COVID-19–related mortality,” the investigators concluded.
In agreement with the investigators, Dr. Conroy said that the increased mortality rate among ICS users should not be misconstrued as a medication-related risk.
“While the study found that those with COPD or asthma taking ICS and high-dose ICS were at an increased risk of death, this could easily be explained by the likelihood that those are the patients who are more likely to have more severe underlying lung disease,” Dr. Conroy said. “While this observational study did attempt to control for exacerbation history, the ability to do so by electronic health records data is certainly imperfect.”
With this in mind, patients with chronic respiratory disease should be encouraged to adhere to their usual treatment regimen, Dr. Conroy added.
“There isn’t evidence to increase or decrease medications just because of the pandemic,” she said. “A patient with asthma or COPD should continue to take the medications that are needed to achieve good control of their lung disease.”
The study was funded by the U.K. Medical Research Council. The investigators reported additional relationships with the Wellcome Trust, the Good Thinking Foundation, the Laura and John Arnold Foundation, and others. Dr. Conroy reported no conflicts of interest.
SOURCE: Schultze A et al. Lancet Respir Med. 2020 Sep 24. doi: 10.1016/ S2213-2600(20)30415-X.
FROM LANCET RESPIRATORY MEDICINE