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Tackling screen time from birth
In this day and age, a new question should make its way to the top of the list for new parents and their pediatricians: How will the family approach the issue of household technology use – for their children as well as themselves?
Even the most vigilant among them will find much available guidance conflicting – and a good deal of it may feel oblivious to their day-to-day realities. This is especially true now, as many families face the daunting demands of pandemic parenting – juggling full-time jobs with childcare and distance learning.
While the American Academy of Pediatrics still specifies daily time limits by age (difficult for many families to achieve even in “normal” times), pediatricians and other child development experts now recognize that a host of factors should inform decisions about healthy screen use. There’s no one “magic number” for acceptable daily use, as not all screen time is the same (particularly during the pandemic) – and different children will experience the effects of technology usage differently.
The quality of content the child engages with; the degree of parental involvement; and the individual cognitive and behavioral considerations of a child are just some of the factors that should be considered. Given the complexities, it’s unfortunate that many parents will not have discussed screen use with their pediatrician or even their partner before their child first reaches for that glowing screen – and certainly not before they are using technology to multitask work, social connections, and day-to-day child rearing. Screen habits form early for both children and families.
An early well-visit priority
Pediatricians have an important role to play in helping families develop a more purposeful approach to household technology by providing them with trusted, evidence-based information on screens and the potential impact on children’s development. This is not information parents should receive when a child is 2 or 3 years of age. By then, toddlers are often already avid tablet users and parents may have come to rely on technology as a parenting aid.
Parents also need to know that, from birth, they can influence their child’s brain and communication development through undistracted time for talking, reading, singing, and interacting with their baby. Though the way children develop speech and language skills has not changed, the level of distraction posed by technology has grown immensely. It is much more difficult for parents to notice a baby’s subtle communication attempts – a coo or a smile, for instance, and respond accordingly – with a smartphone in hand. Rather than admonish parents for overusing their devices, we can focus them on what supports healthy child development instead.
By talking to parents earlier, pediatricians can help prevent premature or excessive exposure to technology – as well as encourage parents to dedicate “unplugged” times of day with their baby, such as during feeding time or before bedtime. By accenting the positive – educating parents about how they can encourage development and growth, how they can bond with their baby, and how they can establish a loving and nurturing relationship – pediatricians can motivate them towards simple steps that limit technology’s disruption of daily developmental opportunities. They can also help them lay a solid foundation for healthy screen time habits in the long term for their family.
The critical period for speech and language development is early
The impact of screen use on a child’s communication development is a significant concern. The critical time window for the development of speech, language, and social skills is between birth and 3 years. What happens then is the precursor for later reading and writing skills that are key to academic and vocational success.
A meta-analysis published in JAMA Pediatrics in July 2020 found that greater quantity of screen use was associated with poorer language skills – while screen-use onset at later ages was also associated with stronger child language skills. A November 2019 JAMA Pediatrics study using brain imaging in pre–school age children found an association between increased screen-based media use, compared with the AAP guidelines, and lower integrity of white matter tracts supporting language and emergent literacy skills. That study also used several language and literacy tests, finding that children with higher screen exposure had poorer expressive language and worse language processing speed. A 2017 study of 900 children between 18 and 24 months found that every 30-minute increase in daily screen time was linked to a 49% increased risk of expressive speech delay. And on the parental side, numerous studies have documented decreased verbal and nonverbal interactions initiated by parents when they are using a device.
Be tech wise with baby
AAP offers many resources in its Media and Children Communication Toolkit that serve as helpful starting points for conversations, including its family media use plan templates. However, more resources tailored to parents of newborns and very young children are needed.
One new option recently developed by the American Speech-Language-Hearing Association (ASHA) and the Children’s Screen Time Action Network is Be Tech Wise With Baby! Aimed at prospective and new parents, this simple handout, available for free in English and Spanish, is an easy takeaway from early well-child visits that pediatricians and pediatric nurses can distribute.
Pediatricians have a vital role to play championing healthy, balanced screen time use for children and adults – starting from baby’s first moments of life. By guiding new parents towards simple steps, such as carving out tech-free times of day and delaying introduction of screens, they can positively influence the screen-time habits of the next generation of connected kids.
Mark Bertin, MD, is a developmental pediatrician and author of numerous parenting books, including “How Children Thrive: The Practical Science of Raising Independent, Resilient, and Happy Kids” and “Mindful Parenting for ADHD.” Diane Paul, PhD, CCC-SLP, is the director of clinical issues in speech-language pathology for the American Speech-Language-Hearing Association (ASHA) and author of numerous books, including “Talking on the Go: Everyday Activities to Enhance Speech and Language Development.” Email them at pdnews@mdedge.com.
In this day and age, a new question should make its way to the top of the list for new parents and their pediatricians: How will the family approach the issue of household technology use – for their children as well as themselves?
Even the most vigilant among them will find much available guidance conflicting – and a good deal of it may feel oblivious to their day-to-day realities. This is especially true now, as many families face the daunting demands of pandemic parenting – juggling full-time jobs with childcare and distance learning.
While the American Academy of Pediatrics still specifies daily time limits by age (difficult for many families to achieve even in “normal” times), pediatricians and other child development experts now recognize that a host of factors should inform decisions about healthy screen use. There’s no one “magic number” for acceptable daily use, as not all screen time is the same (particularly during the pandemic) – and different children will experience the effects of technology usage differently.
The quality of content the child engages with; the degree of parental involvement; and the individual cognitive and behavioral considerations of a child are just some of the factors that should be considered. Given the complexities, it’s unfortunate that many parents will not have discussed screen use with their pediatrician or even their partner before their child first reaches for that glowing screen – and certainly not before they are using technology to multitask work, social connections, and day-to-day child rearing. Screen habits form early for both children and families.
An early well-visit priority
Pediatricians have an important role to play in helping families develop a more purposeful approach to household technology by providing them with trusted, evidence-based information on screens and the potential impact on children’s development. This is not information parents should receive when a child is 2 or 3 years of age. By then, toddlers are often already avid tablet users and parents may have come to rely on technology as a parenting aid.
Parents also need to know that, from birth, they can influence their child’s brain and communication development through undistracted time for talking, reading, singing, and interacting with their baby. Though the way children develop speech and language skills has not changed, the level of distraction posed by technology has grown immensely. It is much more difficult for parents to notice a baby’s subtle communication attempts – a coo or a smile, for instance, and respond accordingly – with a smartphone in hand. Rather than admonish parents for overusing their devices, we can focus them on what supports healthy child development instead.
By talking to parents earlier, pediatricians can help prevent premature or excessive exposure to technology – as well as encourage parents to dedicate “unplugged” times of day with their baby, such as during feeding time or before bedtime. By accenting the positive – educating parents about how they can encourage development and growth, how they can bond with their baby, and how they can establish a loving and nurturing relationship – pediatricians can motivate them towards simple steps that limit technology’s disruption of daily developmental opportunities. They can also help them lay a solid foundation for healthy screen time habits in the long term for their family.
The critical period for speech and language development is early
The impact of screen use on a child’s communication development is a significant concern. The critical time window for the development of speech, language, and social skills is between birth and 3 years. What happens then is the precursor for later reading and writing skills that are key to academic and vocational success.
A meta-analysis published in JAMA Pediatrics in July 2020 found that greater quantity of screen use was associated with poorer language skills – while screen-use onset at later ages was also associated with stronger child language skills. A November 2019 JAMA Pediatrics study using brain imaging in pre–school age children found an association between increased screen-based media use, compared with the AAP guidelines, and lower integrity of white matter tracts supporting language and emergent literacy skills. That study also used several language and literacy tests, finding that children with higher screen exposure had poorer expressive language and worse language processing speed. A 2017 study of 900 children between 18 and 24 months found that every 30-minute increase in daily screen time was linked to a 49% increased risk of expressive speech delay. And on the parental side, numerous studies have documented decreased verbal and nonverbal interactions initiated by parents when they are using a device.
Be tech wise with baby
AAP offers many resources in its Media and Children Communication Toolkit that serve as helpful starting points for conversations, including its family media use plan templates. However, more resources tailored to parents of newborns and very young children are needed.
One new option recently developed by the American Speech-Language-Hearing Association (ASHA) and the Children’s Screen Time Action Network is Be Tech Wise With Baby! Aimed at prospective and new parents, this simple handout, available for free in English and Spanish, is an easy takeaway from early well-child visits that pediatricians and pediatric nurses can distribute.
Pediatricians have a vital role to play championing healthy, balanced screen time use for children and adults – starting from baby’s first moments of life. By guiding new parents towards simple steps, such as carving out tech-free times of day and delaying introduction of screens, they can positively influence the screen-time habits of the next generation of connected kids.
Mark Bertin, MD, is a developmental pediatrician and author of numerous parenting books, including “How Children Thrive: The Practical Science of Raising Independent, Resilient, and Happy Kids” and “Mindful Parenting for ADHD.” Diane Paul, PhD, CCC-SLP, is the director of clinical issues in speech-language pathology for the American Speech-Language-Hearing Association (ASHA) and author of numerous books, including “Talking on the Go: Everyday Activities to Enhance Speech and Language Development.” Email them at pdnews@mdedge.com.
In this day and age, a new question should make its way to the top of the list for new parents and their pediatricians: How will the family approach the issue of household technology use – for their children as well as themselves?
Even the most vigilant among them will find much available guidance conflicting – and a good deal of it may feel oblivious to their day-to-day realities. This is especially true now, as many families face the daunting demands of pandemic parenting – juggling full-time jobs with childcare and distance learning.
While the American Academy of Pediatrics still specifies daily time limits by age (difficult for many families to achieve even in “normal” times), pediatricians and other child development experts now recognize that a host of factors should inform decisions about healthy screen use. There’s no one “magic number” for acceptable daily use, as not all screen time is the same (particularly during the pandemic) – and different children will experience the effects of technology usage differently.
The quality of content the child engages with; the degree of parental involvement; and the individual cognitive and behavioral considerations of a child are just some of the factors that should be considered. Given the complexities, it’s unfortunate that many parents will not have discussed screen use with their pediatrician or even their partner before their child first reaches for that glowing screen – and certainly not before they are using technology to multitask work, social connections, and day-to-day child rearing. Screen habits form early for both children and families.
An early well-visit priority
Pediatricians have an important role to play in helping families develop a more purposeful approach to household technology by providing them with trusted, evidence-based information on screens and the potential impact on children’s development. This is not information parents should receive when a child is 2 or 3 years of age. By then, toddlers are often already avid tablet users and parents may have come to rely on technology as a parenting aid.
Parents also need to know that, from birth, they can influence their child’s brain and communication development through undistracted time for talking, reading, singing, and interacting with their baby. Though the way children develop speech and language skills has not changed, the level of distraction posed by technology has grown immensely. It is much more difficult for parents to notice a baby’s subtle communication attempts – a coo or a smile, for instance, and respond accordingly – with a smartphone in hand. Rather than admonish parents for overusing their devices, we can focus them on what supports healthy child development instead.
By talking to parents earlier, pediatricians can help prevent premature or excessive exposure to technology – as well as encourage parents to dedicate “unplugged” times of day with their baby, such as during feeding time or before bedtime. By accenting the positive – educating parents about how they can encourage development and growth, how they can bond with their baby, and how they can establish a loving and nurturing relationship – pediatricians can motivate them towards simple steps that limit technology’s disruption of daily developmental opportunities. They can also help them lay a solid foundation for healthy screen time habits in the long term for their family.
The critical period for speech and language development is early
The impact of screen use on a child’s communication development is a significant concern. The critical time window for the development of speech, language, and social skills is between birth and 3 years. What happens then is the precursor for later reading and writing skills that are key to academic and vocational success.
A meta-analysis published in JAMA Pediatrics in July 2020 found that greater quantity of screen use was associated with poorer language skills – while screen-use onset at later ages was also associated with stronger child language skills. A November 2019 JAMA Pediatrics study using brain imaging in pre–school age children found an association between increased screen-based media use, compared with the AAP guidelines, and lower integrity of white matter tracts supporting language and emergent literacy skills. That study also used several language and literacy tests, finding that children with higher screen exposure had poorer expressive language and worse language processing speed. A 2017 study of 900 children between 18 and 24 months found that every 30-minute increase in daily screen time was linked to a 49% increased risk of expressive speech delay. And on the parental side, numerous studies have documented decreased verbal and nonverbal interactions initiated by parents when they are using a device.
Be tech wise with baby
AAP offers many resources in its Media and Children Communication Toolkit that serve as helpful starting points for conversations, including its family media use plan templates. However, more resources tailored to parents of newborns and very young children are needed.
One new option recently developed by the American Speech-Language-Hearing Association (ASHA) and the Children’s Screen Time Action Network is Be Tech Wise With Baby! Aimed at prospective and new parents, this simple handout, available for free in English and Spanish, is an easy takeaway from early well-child visits that pediatricians and pediatric nurses can distribute.
Pediatricians have a vital role to play championing healthy, balanced screen time use for children and adults – starting from baby’s first moments of life. By guiding new parents towards simple steps, such as carving out tech-free times of day and delaying introduction of screens, they can positively influence the screen-time habits of the next generation of connected kids.
Mark Bertin, MD, is a developmental pediatrician and author of numerous parenting books, including “How Children Thrive: The Practical Science of Raising Independent, Resilient, and Happy Kids” and “Mindful Parenting for ADHD.” Diane Paul, PhD, CCC-SLP, is the director of clinical issues in speech-language pathology for the American Speech-Language-Hearing Association (ASHA) and author of numerous books, including “Talking on the Go: Everyday Activities to Enhance Speech and Language Development.” Email them at pdnews@mdedge.com.
On being an elite
Regardless of who received the most electoral votes it is pretty clear that each candidate has millions of supporters, and that they are separated by only a few percentage points. I guess one could argue that so many people being able to express their opinions is healthy. However, from my side of the divide I have difficulty understanding how so many of my fellow citizens could arrive at an opinion so diametrically opposed to my own.
Since the 2016 election I have tried to read as many articles as I could find in search of an explanation for that outcome and continuing partisan support. I have never had much interest in political science because it always sounded like an oxymoron. But I am willing to listen to anyone who claims to understand how so many other citizens can see the world so differently from the way I do. It simply may be that for whatever reason one person, in this case one man, has such charismatic power that his supporters willingly abandon the moral skeleton on which their lives had been draped. Or is this us versus them primarily a chasm between the elites and the nonelites?
I don’t know much about you but the fact that you are reading this column means that, like me, you are an elite. Even if you are a woman of color and the daughter of immigrants you have taken advantage of what opportunities you have been offered, stayed in school long enough to adopt a reverence for the scientific method, and have a job that pays well because you have acquired some expertise.
Tom Nichols, a political scientist teaching at Harvard Extension School, says that “expertise is a very exclusionary idea because it’s supposed to be: Not everybody gets a vote on how to fly the plane” (Why isn’t the right more afraid of COVID-19? by Christina Pazzanese, Harvard Gazette, Oct 30, 2020) This exclusivity may in part explain the cultural trend that has eroded faith in experts in general, but particularly around issues such as climate change. Ironically, although science continues to be held in esteem in our culture, many scientists have become targets for those citizens who wish to attack authority figures.
How is it that you and I as pediatricians have avoided those attacks and the derogatory label as “so-called experts”?
You may live and practice in a community where many of your patients’ families don’t share your political views. But you have probably been successful at maintaining a trusting relationship with them in large part because you have cast yourself in the role of an adviser and not a dictator. And, although at times it has been difficult, you have been careful to avoid sharing your advice in a manner that sounds condescending. You have succeeded in functioning as an expert while carefully disguising yourself as a nonelite.
However, you are skating on thin ice if you venture into topics that run counter to your patients’ religious beliefs. Theda Skocpol, professor of government and psychology at Harvard University, Cambridge, Mass., has observed that studies have shown that while religious conservatives are aware of the science and don’t reject the finding, “they resent the use of experts as political authorities.” This may explain why all across this diverse country, our patients are eager for and accepting of our advice on all manners of health-related issues until we step into a swampy area that threatens their political views – such as vaccination or gun control.
With one misstep in the wrong direction, you can go from being a compassionate adviser to an elitist “so-called expert.”
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
Regardless of who received the most electoral votes it is pretty clear that each candidate has millions of supporters, and that they are separated by only a few percentage points. I guess one could argue that so many people being able to express their opinions is healthy. However, from my side of the divide I have difficulty understanding how so many of my fellow citizens could arrive at an opinion so diametrically opposed to my own.
Since the 2016 election I have tried to read as many articles as I could find in search of an explanation for that outcome and continuing partisan support. I have never had much interest in political science because it always sounded like an oxymoron. But I am willing to listen to anyone who claims to understand how so many other citizens can see the world so differently from the way I do. It simply may be that for whatever reason one person, in this case one man, has such charismatic power that his supporters willingly abandon the moral skeleton on which their lives had been draped. Or is this us versus them primarily a chasm between the elites and the nonelites?
I don’t know much about you but the fact that you are reading this column means that, like me, you are an elite. Even if you are a woman of color and the daughter of immigrants you have taken advantage of what opportunities you have been offered, stayed in school long enough to adopt a reverence for the scientific method, and have a job that pays well because you have acquired some expertise.
Tom Nichols, a political scientist teaching at Harvard Extension School, says that “expertise is a very exclusionary idea because it’s supposed to be: Not everybody gets a vote on how to fly the plane” (Why isn’t the right more afraid of COVID-19? by Christina Pazzanese, Harvard Gazette, Oct 30, 2020) This exclusivity may in part explain the cultural trend that has eroded faith in experts in general, but particularly around issues such as climate change. Ironically, although science continues to be held in esteem in our culture, many scientists have become targets for those citizens who wish to attack authority figures.
How is it that you and I as pediatricians have avoided those attacks and the derogatory label as “so-called experts”?
You may live and practice in a community where many of your patients’ families don’t share your political views. But you have probably been successful at maintaining a trusting relationship with them in large part because you have cast yourself in the role of an adviser and not a dictator. And, although at times it has been difficult, you have been careful to avoid sharing your advice in a manner that sounds condescending. You have succeeded in functioning as an expert while carefully disguising yourself as a nonelite.
However, you are skating on thin ice if you venture into topics that run counter to your patients’ religious beliefs. Theda Skocpol, professor of government and psychology at Harvard University, Cambridge, Mass., has observed that studies have shown that while religious conservatives are aware of the science and don’t reject the finding, “they resent the use of experts as political authorities.” This may explain why all across this diverse country, our patients are eager for and accepting of our advice on all manners of health-related issues until we step into a swampy area that threatens their political views – such as vaccination or gun control.
With one misstep in the wrong direction, you can go from being a compassionate adviser to an elitist “so-called expert.”
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
Regardless of who received the most electoral votes it is pretty clear that each candidate has millions of supporters, and that they are separated by only a few percentage points. I guess one could argue that so many people being able to express their opinions is healthy. However, from my side of the divide I have difficulty understanding how so many of my fellow citizens could arrive at an opinion so diametrically opposed to my own.
Since the 2016 election I have tried to read as many articles as I could find in search of an explanation for that outcome and continuing partisan support. I have never had much interest in political science because it always sounded like an oxymoron. But I am willing to listen to anyone who claims to understand how so many other citizens can see the world so differently from the way I do. It simply may be that for whatever reason one person, in this case one man, has such charismatic power that his supporters willingly abandon the moral skeleton on which their lives had been draped. Or is this us versus them primarily a chasm between the elites and the nonelites?
I don’t know much about you but the fact that you are reading this column means that, like me, you are an elite. Even if you are a woman of color and the daughter of immigrants you have taken advantage of what opportunities you have been offered, stayed in school long enough to adopt a reverence for the scientific method, and have a job that pays well because you have acquired some expertise.
Tom Nichols, a political scientist teaching at Harvard Extension School, says that “expertise is a very exclusionary idea because it’s supposed to be: Not everybody gets a vote on how to fly the plane” (Why isn’t the right more afraid of COVID-19? by Christina Pazzanese, Harvard Gazette, Oct 30, 2020) This exclusivity may in part explain the cultural trend that has eroded faith in experts in general, but particularly around issues such as climate change. Ironically, although science continues to be held in esteem in our culture, many scientists have become targets for those citizens who wish to attack authority figures.
How is it that you and I as pediatricians have avoided those attacks and the derogatory label as “so-called experts”?
You may live and practice in a community where many of your patients’ families don’t share your political views. But you have probably been successful at maintaining a trusting relationship with them in large part because you have cast yourself in the role of an adviser and not a dictator. And, although at times it has been difficult, you have been careful to avoid sharing your advice in a manner that sounds condescending. You have succeeded in functioning as an expert while carefully disguising yourself as a nonelite.
However, you are skating on thin ice if you venture into topics that run counter to your patients’ religious beliefs. Theda Skocpol, professor of government and psychology at Harvard University, Cambridge, Mass., has observed that studies have shown that while religious conservatives are aware of the science and don’t reject the finding, “they resent the use of experts as political authorities.” This may explain why all across this diverse country, our patients are eager for and accepting of our advice on all manners of health-related issues until we step into a swampy area that threatens their political views – such as vaccination or gun control.
With one misstep in the wrong direction, you can go from being a compassionate adviser to an elitist “so-called expert.”
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.
Strategies for tracking SARS-CoV-2 could help detect next pandemic
Two recently published studies indicate that COVID-19 infections were already circulating in the United States in December 2019. The question is whether these methodologies that could be applied to track the next pandemic.
One study evaluating blood donations found antibodies on the West coast as early as Dec. 13, 2019, and in blood donated on the East Coast by early January 2020 (Clin Infect Dis. 2020; Nov 30. doi: 10.1093/cid/ciaa1785). Both preceded the first documented COVID-19 infection in the United States, which has been widely reported as occurring on Jan. 19, 2020, in a traveler returning from China.
The other study, utilizing electronic medical record (EMR) analytics, demonstrated a spike in visits or hospitalizations for cough, a trend that persisted from Dec. 22, 2019, onward, exceeding norms for seasonal flu ( J Med Internet Res. 2020;22:e21562). This spike was interpreted as evidence that the SARS-CoV-2 pandemic was already underway before the first case was established.
While the ongoing serologic testing of blood donations for viral antibodies “will advance understanding of the epidemiology” for SARS-CoV-2 and “inform allocation of resources and public health prevention interventions to mitigate morbidity and mortality,” it might also be a strategy for disease surveillance in the next pandemic, according to a team led by investigators at the Centers for Disease Control and Prevention.
Blood donation surveillance is not now used routinely to monitor for population-based health threats, but it is not a new idea, according to the lead author of the study, Sridhar V. Basavaraju, MD, of Emory University and director of the CDC’s Office of Blood, Organ, and Other Tissue Safety, Atlanta, and his coinvestigators. Most recently, blood donation surveillance was used in the United States to track the penetration of the Zika virus.
For early detection of respiratory infections, blood donations might have unique advantages over alternatives, such as surveillance of respiratory specimens from symptomatic patients. Not least, blood donation surveillance captures individuals who are not seeking medical care, according to the investigators.
EMR surveillance might also have unique advantages for population-based monitoring of health threats. For one, aggregate data from large EMR systems have the potential to reveal symptom patterns before they become apparent at level of clinical care, according to a team of collaborating investigators from the University of California, Los Angeles, and the University of Washington, Seattle.
Emphasizing an urgent need for “agile healthcare analytics” to enable “disease surveillance in real time,” the first author of the EMR study, Joann G. Elmore, MD, professor in the department of health policy and management at the University of California, Los Angeles, expressed the hope that the approach will “lead to better preparation and the ability to quickly provide warnings and track the next pandemic.”
In the blood donation surveillance study, the goal was simply to determine whether SARS-CoV-2 reactive antibodies could be found in blood donations before the first case was identified. Of the 7,389 archived blood samples tested between Dec. 13, 2019, and Jan. 17, 2020, 106 (1.4%) were reactive.
These were not true positives, acknowledged the investigators. True positives would require reactive antibodies in the context of a positive molecular diagnostic test or paired acute convalescent sera with rising titers. The investigators also cautioned that false positives could not be completely ruled out, particularly in light of cross-reactivity that has been reported with other human coronaviruses.
Nevertheless, the monitoring of blood donations offers substantial promise for “understanding the dynamics of SARS-CoV-2 pandemic from early introduction,” and the CDC is now collaborating on ongoing surveillance with the goal of contributing information that could be applied “to mitigate morbidity and mortality.”
Lessons learned from this pandemic are potentially relevant to the next.
The EMR study simply looked at whether the word “cough” was included more often in the notes from visits or hospitalizations between December 2019 and February 2020 relative to the preceding 5 years. The investigators drew on data from three hospitals and more than 180 clinics.
From Dec. 22, 2019, onward, cough was noted above the 95% prediction interval for all 10 weeks of the study. The excess was seen in the outpatient setting and among hospitalized patients. There was also significant excess in the number of patients hospitalized with acute respiratory failure during the study period.
“Our approach to analyzing electronic records could be helpful in the future as we included consideration of data from the outpatient clinics in addition to the emergency departments and inpatient settings,” Dr. Elmore reported.
Surveillance of influenza and influenza-like infections has been undertaken in the United States for more than 20 years, but Dr. Elmore contends that EMR data, particularly data from outpatient clinics are “usually a harbinger of what is to come” for emergency department visits and, ultimately, hospitalizations. She thinks that this is a resource not yet fully exploited.
“There are always opportunities to better harness EMR data,” Dr. Elmore said.
These are intriguing studies and “useful” for reconsidering when SARS-CoV-2 was introduced in the United States, according to Janet G. Basemen, PhD, a professor of epidemiology and the associate dean of the University of Washington School of Public Health, Seattle. However, she noted that the task of translating data like these into actionable public health strategies has proven difficult in the past.
Symptom-based surveillance systems “have mostly served as situational awareness rather than early detection tools,” Dr. Baseman said. The problem is timely interpretation of a given signal.
Not that she doubts such tools “would be an incredible resource for humanity” if the current limitations can be resolved or that technological advances will lead to better methods of detecting and monitoring pandemics “at some point.” Rather, “we’re just not there yet,” she said.
SOURCE: Basavaraju SV et al. Clin Infect Dis. 2020 Nov 30. doi: 10.1093/cid/ciaa1785); Elmore JG et al. J Med Internet Res. 2020;22:e21562).
Two recently published studies indicate that COVID-19 infections were already circulating in the United States in December 2019. The question is whether these methodologies that could be applied to track the next pandemic.
One study evaluating blood donations found antibodies on the West coast as early as Dec. 13, 2019, and in blood donated on the East Coast by early January 2020 (Clin Infect Dis. 2020; Nov 30. doi: 10.1093/cid/ciaa1785). Both preceded the first documented COVID-19 infection in the United States, which has been widely reported as occurring on Jan. 19, 2020, in a traveler returning from China.
The other study, utilizing electronic medical record (EMR) analytics, demonstrated a spike in visits or hospitalizations for cough, a trend that persisted from Dec. 22, 2019, onward, exceeding norms for seasonal flu ( J Med Internet Res. 2020;22:e21562). This spike was interpreted as evidence that the SARS-CoV-2 pandemic was already underway before the first case was established.
While the ongoing serologic testing of blood donations for viral antibodies “will advance understanding of the epidemiology” for SARS-CoV-2 and “inform allocation of resources and public health prevention interventions to mitigate morbidity and mortality,” it might also be a strategy for disease surveillance in the next pandemic, according to a team led by investigators at the Centers for Disease Control and Prevention.
Blood donation surveillance is not now used routinely to monitor for population-based health threats, but it is not a new idea, according to the lead author of the study, Sridhar V. Basavaraju, MD, of Emory University and director of the CDC’s Office of Blood, Organ, and Other Tissue Safety, Atlanta, and his coinvestigators. Most recently, blood donation surveillance was used in the United States to track the penetration of the Zika virus.
For early detection of respiratory infections, blood donations might have unique advantages over alternatives, such as surveillance of respiratory specimens from symptomatic patients. Not least, blood donation surveillance captures individuals who are not seeking medical care, according to the investigators.
EMR surveillance might also have unique advantages for population-based monitoring of health threats. For one, aggregate data from large EMR systems have the potential to reveal symptom patterns before they become apparent at level of clinical care, according to a team of collaborating investigators from the University of California, Los Angeles, and the University of Washington, Seattle.
Emphasizing an urgent need for “agile healthcare analytics” to enable “disease surveillance in real time,” the first author of the EMR study, Joann G. Elmore, MD, professor in the department of health policy and management at the University of California, Los Angeles, expressed the hope that the approach will “lead to better preparation and the ability to quickly provide warnings and track the next pandemic.”
In the blood donation surveillance study, the goal was simply to determine whether SARS-CoV-2 reactive antibodies could be found in blood donations before the first case was identified. Of the 7,389 archived blood samples tested between Dec. 13, 2019, and Jan. 17, 2020, 106 (1.4%) were reactive.
These were not true positives, acknowledged the investigators. True positives would require reactive antibodies in the context of a positive molecular diagnostic test or paired acute convalescent sera with rising titers. The investigators also cautioned that false positives could not be completely ruled out, particularly in light of cross-reactivity that has been reported with other human coronaviruses.
Nevertheless, the monitoring of blood donations offers substantial promise for “understanding the dynamics of SARS-CoV-2 pandemic from early introduction,” and the CDC is now collaborating on ongoing surveillance with the goal of contributing information that could be applied “to mitigate morbidity and mortality.”
Lessons learned from this pandemic are potentially relevant to the next.
The EMR study simply looked at whether the word “cough” was included more often in the notes from visits or hospitalizations between December 2019 and February 2020 relative to the preceding 5 years. The investigators drew on data from three hospitals and more than 180 clinics.
From Dec. 22, 2019, onward, cough was noted above the 95% prediction interval for all 10 weeks of the study. The excess was seen in the outpatient setting and among hospitalized patients. There was also significant excess in the number of patients hospitalized with acute respiratory failure during the study period.
“Our approach to analyzing electronic records could be helpful in the future as we included consideration of data from the outpatient clinics in addition to the emergency departments and inpatient settings,” Dr. Elmore reported.
Surveillance of influenza and influenza-like infections has been undertaken in the United States for more than 20 years, but Dr. Elmore contends that EMR data, particularly data from outpatient clinics are “usually a harbinger of what is to come” for emergency department visits and, ultimately, hospitalizations. She thinks that this is a resource not yet fully exploited.
“There are always opportunities to better harness EMR data,” Dr. Elmore said.
These are intriguing studies and “useful” for reconsidering when SARS-CoV-2 was introduced in the United States, according to Janet G. Basemen, PhD, a professor of epidemiology and the associate dean of the University of Washington School of Public Health, Seattle. However, she noted that the task of translating data like these into actionable public health strategies has proven difficult in the past.
Symptom-based surveillance systems “have mostly served as situational awareness rather than early detection tools,” Dr. Baseman said. The problem is timely interpretation of a given signal.
Not that she doubts such tools “would be an incredible resource for humanity” if the current limitations can be resolved or that technological advances will lead to better methods of detecting and monitoring pandemics “at some point.” Rather, “we’re just not there yet,” she said.
SOURCE: Basavaraju SV et al. Clin Infect Dis. 2020 Nov 30. doi: 10.1093/cid/ciaa1785); Elmore JG et al. J Med Internet Res. 2020;22:e21562).
Two recently published studies indicate that COVID-19 infections were already circulating in the United States in December 2019. The question is whether these methodologies that could be applied to track the next pandemic.
One study evaluating blood donations found antibodies on the West coast as early as Dec. 13, 2019, and in blood donated on the East Coast by early January 2020 (Clin Infect Dis. 2020; Nov 30. doi: 10.1093/cid/ciaa1785). Both preceded the first documented COVID-19 infection in the United States, which has been widely reported as occurring on Jan. 19, 2020, in a traveler returning from China.
The other study, utilizing electronic medical record (EMR) analytics, demonstrated a spike in visits or hospitalizations for cough, a trend that persisted from Dec. 22, 2019, onward, exceeding norms for seasonal flu ( J Med Internet Res. 2020;22:e21562). This spike was interpreted as evidence that the SARS-CoV-2 pandemic was already underway before the first case was established.
While the ongoing serologic testing of blood donations for viral antibodies “will advance understanding of the epidemiology” for SARS-CoV-2 and “inform allocation of resources and public health prevention interventions to mitigate morbidity and mortality,” it might also be a strategy for disease surveillance in the next pandemic, according to a team led by investigators at the Centers for Disease Control and Prevention.
Blood donation surveillance is not now used routinely to monitor for population-based health threats, but it is not a new idea, according to the lead author of the study, Sridhar V. Basavaraju, MD, of Emory University and director of the CDC’s Office of Blood, Organ, and Other Tissue Safety, Atlanta, and his coinvestigators. Most recently, blood donation surveillance was used in the United States to track the penetration of the Zika virus.
For early detection of respiratory infections, blood donations might have unique advantages over alternatives, such as surveillance of respiratory specimens from symptomatic patients. Not least, blood donation surveillance captures individuals who are not seeking medical care, according to the investigators.
EMR surveillance might also have unique advantages for population-based monitoring of health threats. For one, aggregate data from large EMR systems have the potential to reveal symptom patterns before they become apparent at level of clinical care, according to a team of collaborating investigators from the University of California, Los Angeles, and the University of Washington, Seattle.
Emphasizing an urgent need for “agile healthcare analytics” to enable “disease surveillance in real time,” the first author of the EMR study, Joann G. Elmore, MD, professor in the department of health policy and management at the University of California, Los Angeles, expressed the hope that the approach will “lead to better preparation and the ability to quickly provide warnings and track the next pandemic.”
In the blood donation surveillance study, the goal was simply to determine whether SARS-CoV-2 reactive antibodies could be found in blood donations before the first case was identified. Of the 7,389 archived blood samples tested between Dec. 13, 2019, and Jan. 17, 2020, 106 (1.4%) were reactive.
These were not true positives, acknowledged the investigators. True positives would require reactive antibodies in the context of a positive molecular diagnostic test or paired acute convalescent sera with rising titers. The investigators also cautioned that false positives could not be completely ruled out, particularly in light of cross-reactivity that has been reported with other human coronaviruses.
Nevertheless, the monitoring of blood donations offers substantial promise for “understanding the dynamics of SARS-CoV-2 pandemic from early introduction,” and the CDC is now collaborating on ongoing surveillance with the goal of contributing information that could be applied “to mitigate morbidity and mortality.”
Lessons learned from this pandemic are potentially relevant to the next.
The EMR study simply looked at whether the word “cough” was included more often in the notes from visits or hospitalizations between December 2019 and February 2020 relative to the preceding 5 years. The investigators drew on data from three hospitals and more than 180 clinics.
From Dec. 22, 2019, onward, cough was noted above the 95% prediction interval for all 10 weeks of the study. The excess was seen in the outpatient setting and among hospitalized patients. There was also significant excess in the number of patients hospitalized with acute respiratory failure during the study period.
“Our approach to analyzing electronic records could be helpful in the future as we included consideration of data from the outpatient clinics in addition to the emergency departments and inpatient settings,” Dr. Elmore reported.
Surveillance of influenza and influenza-like infections has been undertaken in the United States for more than 20 years, but Dr. Elmore contends that EMR data, particularly data from outpatient clinics are “usually a harbinger of what is to come” for emergency department visits and, ultimately, hospitalizations. She thinks that this is a resource not yet fully exploited.
“There are always opportunities to better harness EMR data,” Dr. Elmore said.
These are intriguing studies and “useful” for reconsidering when SARS-CoV-2 was introduced in the United States, according to Janet G. Basemen, PhD, a professor of epidemiology and the associate dean of the University of Washington School of Public Health, Seattle. However, she noted that the task of translating data like these into actionable public health strategies has proven difficult in the past.
Symptom-based surveillance systems “have mostly served as situational awareness rather than early detection tools,” Dr. Baseman said. The problem is timely interpretation of a given signal.
Not that she doubts such tools “would be an incredible resource for humanity” if the current limitations can be resolved or that technological advances will lead to better methods of detecting and monitoring pandemics “at some point.” Rather, “we’re just not there yet,” she said.
SOURCE: Basavaraju SV et al. Clin Infect Dis. 2020 Nov 30. doi: 10.1093/cid/ciaa1785); Elmore JG et al. J Med Internet Res. 2020;22:e21562).
Doctors publish paper on COVID-19 protocol; Experts unconvinced
Physicians who developed a protocol for treating hospitalized patients with COVID-19 they call MATH+ have now published a literature review with observational mortality rates in the Journal of Intensive Care Medicine (JICM) that they say supports the protocol’s use.
The physicians have been promoting their MATH+ protocol as a way to improve survival from severe COVID-19 since the spring, and this is the first time their protocol and any results have been published in a peer-reviewed journal. But because the paper contains only hospital-level mortality rates compared with previously published observational data and clinical trials (not data from a randomized controlled trial testing the protocol), experts remain unconvinced the protocol benefits patients.
“This is not a study by any stretch of the imagination,” Hugh Cassiere, MD, director of critical care medicine at North Shore University Hospital in Manhasset, New York, told Medscape Medical News via email. “It is comparative data which should never be used to make conclusions of one therapy over another.”
“It’s food for thought for those clinicians [treating COVID-19] and it gives them some options,” said Pierre Kory, MD, MPA, a pulmonary critical care specialist in Wisconsin and one of the protocol developers. “What we really emphasize for this disease is it has to be a combination therapy protocol.”
As Medscape previously reported, MATH+ stands for methylprednisolone, ascorbic acid, thiamine, and heparin. The “+” includes additional therapies like vitamin D, zinc, melatonin, statins, and famotidine. The protocol originated as a variation of the “HAT therapy,” a combination of hydrocortisone, ascorbic acid, and thiamine, which critical care specialist Paul Marik, MD, created for treating critically ill patients with sepsis.
The protocol evolved over a few weeks this spring as Marik, chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, emailed with a small group of colleagues about treatments and their observations of SARS-CoV-2 in action. In March, when Marik and his colleagues formalized the MATH+ protocol, healthcare organizations like the World Health Organization (WHO) were advising against steroids for COVID-19 patients.
Determined to spread a different message, the MATH+ physicians began publicizing the protocol with a website and a small communications team. They tried to get their protocol in front of leading healthcare organizations, like the WHO, and Kory testified remotely in front of the Senate Homeland Security Committee in early May. (Kory testified in front of the committee again earlier this month about the use of ivermectin as a COVID-19 treatment. He told Medscape the MATH+ protocol has been updated to include ivermectin since the submission to JICM.)
The physicians have continued promoting the protocol in the summer and fall, even after the RECOVERY trial showed dexamethasone treatment decreased mortality in hospitalized patients with severe COVID-19 and the WHO and other organizations started recommending the drug.
In the newly published JICM article, the researchers describe a mix of randomized controlled trials, observational studies, and basic science research that inform each of the individual pieces of the MATH+ protocol. Some of the cited research pertains specifically to the treatment of COVID-19.
Other studies the authors use to support the protocol are based on data from other viral outbreaks, like H1N1 and SARS-CoV, as well as other medical conditions, like nonviral acute respiratory distress syndrome and sepsis. The researchers did not conduct a randomized controlled trial of MATH+ for patients with COVID-19 because, as they write in the article, they did not believe they had the clinical equipoise required for such a study.
“With respect to each of the individual ‘core’ therapies of MATH+, all authors felt the therapies either superior to any placebo or possessed evidence of minimal risk and cost compared to potential benefit,” they wrote in the paper.
“With a new disease, it is totally reasonable to take your best guess at a therapy,” wrote F. Perry Wilson, MD, MSCE, director of the Clinical and Translational Research Accelerator at Yale University School of Medicine, in an email to Medscape. “When there is limited information, you go with what you have. What I take issue with here is the authors’ implication that that’s where the scientific process stops. In my mind, it’s actually just the beginning.” Every investigator believes his or her intervention is beneficial but is not sure — that’s why they conduct a randomized controlled trial, Wilson said.
“Without robust trials, we are left with too many options on the table and no way to know what helps — leading to this ‘throw the book at them’ approach, where you just pick your favorite molecule and give it,” said Wilson.
Sam Parnia, MD, PhD, associate professor of medicine and director of critical care and resuscitation research at NYU Langone, echoed this sentiment: “Many of the individual components could be expected to provide benefit and combining therapies is something physicians often do,” Parnia said in an email to Medscape. “I think this is a promising approach; however, this ultimately needs to be studied.”
: United Memorial Hospital in Houston, Texas and Norfolk General Hospital in Norfolk, Virginia. At United Memorial, MATH+ was “systematically” followed for patients admitted to the hospital, and at Norfolk General it was followed for patients admitted to the ICU. The two hospitals treated 140 and 191 COVID-19 patients with MATH+, respectively, as of July 20.
The average observed hospital or 28-day mortality rate at United Memorial was 4.4% and at Norfolk General was 6.1%, for a combined mortality rate of 5.1%. The researchers compared this rate with reported outcomes from 10 studies of more than 400 hospitals in the United States (72 hospitals), the United Kingdom (386), and China (3). The mortality rate for COVID-19 patients at these hospitals ranged from 15.6% to 32%, for an average mortality rate of 22.9%.
The difference in average mortality rates represents a “more than 75% absolute risk reduction in mortality” with MATH+, according to the authors. The data from other hospitals were reported from January to early June, representative of death rates early in the pandemic and before the announcement of the RECOVERY trial results spurred increased use of dexamethasone.
The new numbers may not be convincing to other physicians.
“The comparison of the outcomes in the two hospitals where this protocol is implemented vs mortality rates in other published studies is quite a stretch,” Wilson told Medscape. “Hospitals with robust research programs that publish large cohorts tend to be tertiary care centers where sick patients get referred. Without data on the baseline characteristics of the patients in these studies, it’s really not appropriate to draw apples-to-apples comparisons.”
“There are many factors that lead to different mortality rates [between hospitals] and it often reflects the quality of general ICU care,” said Parnia. For example, many ICUs were overwhelmed and stretched during the pandemic, while others were not.
“This protocol remains a hypothesis in need of a prospective clinical trial,” said Daniel Kaul, MD, professor of infectious diseases at the University of Michigan, Ann Arbor. “Comparing gross mortality rates from different centers at different times with different case mixes is at most hypothesis generating.”
“The use of comparative data is useless information…not based on true comparison of groups,” said Cassiere of the average mortality rates. Only a randomized, placebo-controlled trial can prove if a treatment is effective. “This protocol should be abandoned.”
“The MATH+ is based on negative evidence,” Cassiere told Medscape, pointing to trials that showed no effect for vitamin C (ascorbic acid) and thiamine in critical illnesses. And, given the “overwhelming positive data’’ for dexamethasone to treat patients with severe COVID-19, its exclusion from MATH+ in favor of a steroid that has not been extensively studied for COVID-19 is “reckless and irresponsible,” he said.
Kory pushed back strongly against this assertion, pointing to the decades of research on methylprednisolone as a treatment for lung disease and ARDS outlined in the article. “It has far more evidence than dexamethasone,” he told Medscape over the phone.
“Our recommendation is based on a clear understanding of the pharmacological principle to guide prolonged glucocorticoid administration in ARDS and COVID-19,” wrote G. Umberto Meduri, MD, a MATH+ coauthor and professor in the Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Tennessee Health Science Center in Memphis.
A version of this article first appeared on Medscape.com.
Physicians who developed a protocol for treating hospitalized patients with COVID-19 they call MATH+ have now published a literature review with observational mortality rates in the Journal of Intensive Care Medicine (JICM) that they say supports the protocol’s use.
The physicians have been promoting their MATH+ protocol as a way to improve survival from severe COVID-19 since the spring, and this is the first time their protocol and any results have been published in a peer-reviewed journal. But because the paper contains only hospital-level mortality rates compared with previously published observational data and clinical trials (not data from a randomized controlled trial testing the protocol), experts remain unconvinced the protocol benefits patients.
“This is not a study by any stretch of the imagination,” Hugh Cassiere, MD, director of critical care medicine at North Shore University Hospital in Manhasset, New York, told Medscape Medical News via email. “It is comparative data which should never be used to make conclusions of one therapy over another.”
“It’s food for thought for those clinicians [treating COVID-19] and it gives them some options,” said Pierre Kory, MD, MPA, a pulmonary critical care specialist in Wisconsin and one of the protocol developers. “What we really emphasize for this disease is it has to be a combination therapy protocol.”
As Medscape previously reported, MATH+ stands for methylprednisolone, ascorbic acid, thiamine, and heparin. The “+” includes additional therapies like vitamin D, zinc, melatonin, statins, and famotidine. The protocol originated as a variation of the “HAT therapy,” a combination of hydrocortisone, ascorbic acid, and thiamine, which critical care specialist Paul Marik, MD, created for treating critically ill patients with sepsis.
The protocol evolved over a few weeks this spring as Marik, chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, emailed with a small group of colleagues about treatments and their observations of SARS-CoV-2 in action. In March, when Marik and his colleagues formalized the MATH+ protocol, healthcare organizations like the World Health Organization (WHO) were advising against steroids for COVID-19 patients.
Determined to spread a different message, the MATH+ physicians began publicizing the protocol with a website and a small communications team. They tried to get their protocol in front of leading healthcare organizations, like the WHO, and Kory testified remotely in front of the Senate Homeland Security Committee in early May. (Kory testified in front of the committee again earlier this month about the use of ivermectin as a COVID-19 treatment. He told Medscape the MATH+ protocol has been updated to include ivermectin since the submission to JICM.)
The physicians have continued promoting the protocol in the summer and fall, even after the RECOVERY trial showed dexamethasone treatment decreased mortality in hospitalized patients with severe COVID-19 and the WHO and other organizations started recommending the drug.
In the newly published JICM article, the researchers describe a mix of randomized controlled trials, observational studies, and basic science research that inform each of the individual pieces of the MATH+ protocol. Some of the cited research pertains specifically to the treatment of COVID-19.
Other studies the authors use to support the protocol are based on data from other viral outbreaks, like H1N1 and SARS-CoV, as well as other medical conditions, like nonviral acute respiratory distress syndrome and sepsis. The researchers did not conduct a randomized controlled trial of MATH+ for patients with COVID-19 because, as they write in the article, they did not believe they had the clinical equipoise required for such a study.
“With respect to each of the individual ‘core’ therapies of MATH+, all authors felt the therapies either superior to any placebo or possessed evidence of minimal risk and cost compared to potential benefit,” they wrote in the paper.
“With a new disease, it is totally reasonable to take your best guess at a therapy,” wrote F. Perry Wilson, MD, MSCE, director of the Clinical and Translational Research Accelerator at Yale University School of Medicine, in an email to Medscape. “When there is limited information, you go with what you have. What I take issue with here is the authors’ implication that that’s where the scientific process stops. In my mind, it’s actually just the beginning.” Every investigator believes his or her intervention is beneficial but is not sure — that’s why they conduct a randomized controlled trial, Wilson said.
“Without robust trials, we are left with too many options on the table and no way to know what helps — leading to this ‘throw the book at them’ approach, where you just pick your favorite molecule and give it,” said Wilson.
Sam Parnia, MD, PhD, associate professor of medicine and director of critical care and resuscitation research at NYU Langone, echoed this sentiment: “Many of the individual components could be expected to provide benefit and combining therapies is something physicians often do,” Parnia said in an email to Medscape. “I think this is a promising approach; however, this ultimately needs to be studied.”
: United Memorial Hospital in Houston, Texas and Norfolk General Hospital in Norfolk, Virginia. At United Memorial, MATH+ was “systematically” followed for patients admitted to the hospital, and at Norfolk General it was followed for patients admitted to the ICU. The two hospitals treated 140 and 191 COVID-19 patients with MATH+, respectively, as of July 20.
The average observed hospital or 28-day mortality rate at United Memorial was 4.4% and at Norfolk General was 6.1%, for a combined mortality rate of 5.1%. The researchers compared this rate with reported outcomes from 10 studies of more than 400 hospitals in the United States (72 hospitals), the United Kingdom (386), and China (3). The mortality rate for COVID-19 patients at these hospitals ranged from 15.6% to 32%, for an average mortality rate of 22.9%.
The difference in average mortality rates represents a “more than 75% absolute risk reduction in mortality” with MATH+, according to the authors. The data from other hospitals were reported from January to early June, representative of death rates early in the pandemic and before the announcement of the RECOVERY trial results spurred increased use of dexamethasone.
The new numbers may not be convincing to other physicians.
“The comparison of the outcomes in the two hospitals where this protocol is implemented vs mortality rates in other published studies is quite a stretch,” Wilson told Medscape. “Hospitals with robust research programs that publish large cohorts tend to be tertiary care centers where sick patients get referred. Without data on the baseline characteristics of the patients in these studies, it’s really not appropriate to draw apples-to-apples comparisons.”
“There are many factors that lead to different mortality rates [between hospitals] and it often reflects the quality of general ICU care,” said Parnia. For example, many ICUs were overwhelmed and stretched during the pandemic, while others were not.
“This protocol remains a hypothesis in need of a prospective clinical trial,” said Daniel Kaul, MD, professor of infectious diseases at the University of Michigan, Ann Arbor. “Comparing gross mortality rates from different centers at different times with different case mixes is at most hypothesis generating.”
“The use of comparative data is useless information…not based on true comparison of groups,” said Cassiere of the average mortality rates. Only a randomized, placebo-controlled trial can prove if a treatment is effective. “This protocol should be abandoned.”
“The MATH+ is based on negative evidence,” Cassiere told Medscape, pointing to trials that showed no effect for vitamin C (ascorbic acid) and thiamine in critical illnesses. And, given the “overwhelming positive data’’ for dexamethasone to treat patients with severe COVID-19, its exclusion from MATH+ in favor of a steroid that has not been extensively studied for COVID-19 is “reckless and irresponsible,” he said.
Kory pushed back strongly against this assertion, pointing to the decades of research on methylprednisolone as a treatment for lung disease and ARDS outlined in the article. “It has far more evidence than dexamethasone,” he told Medscape over the phone.
“Our recommendation is based on a clear understanding of the pharmacological principle to guide prolonged glucocorticoid administration in ARDS and COVID-19,” wrote G. Umberto Meduri, MD, a MATH+ coauthor and professor in the Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Tennessee Health Science Center in Memphis.
A version of this article first appeared on Medscape.com.
Physicians who developed a protocol for treating hospitalized patients with COVID-19 they call MATH+ have now published a literature review with observational mortality rates in the Journal of Intensive Care Medicine (JICM) that they say supports the protocol’s use.
The physicians have been promoting their MATH+ protocol as a way to improve survival from severe COVID-19 since the spring, and this is the first time their protocol and any results have been published in a peer-reviewed journal. But because the paper contains only hospital-level mortality rates compared with previously published observational data and clinical trials (not data from a randomized controlled trial testing the protocol), experts remain unconvinced the protocol benefits patients.
“This is not a study by any stretch of the imagination,” Hugh Cassiere, MD, director of critical care medicine at North Shore University Hospital in Manhasset, New York, told Medscape Medical News via email. “It is comparative data which should never be used to make conclusions of one therapy over another.”
“It’s food for thought for those clinicians [treating COVID-19] and it gives them some options,” said Pierre Kory, MD, MPA, a pulmonary critical care specialist in Wisconsin and one of the protocol developers. “What we really emphasize for this disease is it has to be a combination therapy protocol.”
As Medscape previously reported, MATH+ stands for methylprednisolone, ascorbic acid, thiamine, and heparin. The “+” includes additional therapies like vitamin D, zinc, melatonin, statins, and famotidine. The protocol originated as a variation of the “HAT therapy,” a combination of hydrocortisone, ascorbic acid, and thiamine, which critical care specialist Paul Marik, MD, created for treating critically ill patients with sepsis.
The protocol evolved over a few weeks this spring as Marik, chief of the division of pulmonary and critical care medicine at Eastern Virginia Medical School in Norfolk, emailed with a small group of colleagues about treatments and their observations of SARS-CoV-2 in action. In March, when Marik and his colleagues formalized the MATH+ protocol, healthcare organizations like the World Health Organization (WHO) were advising against steroids for COVID-19 patients.
Determined to spread a different message, the MATH+ physicians began publicizing the protocol with a website and a small communications team. They tried to get their protocol in front of leading healthcare organizations, like the WHO, and Kory testified remotely in front of the Senate Homeland Security Committee in early May. (Kory testified in front of the committee again earlier this month about the use of ivermectin as a COVID-19 treatment. He told Medscape the MATH+ protocol has been updated to include ivermectin since the submission to JICM.)
The physicians have continued promoting the protocol in the summer and fall, even after the RECOVERY trial showed dexamethasone treatment decreased mortality in hospitalized patients with severe COVID-19 and the WHO and other organizations started recommending the drug.
In the newly published JICM article, the researchers describe a mix of randomized controlled trials, observational studies, and basic science research that inform each of the individual pieces of the MATH+ protocol. Some of the cited research pertains specifically to the treatment of COVID-19.
Other studies the authors use to support the protocol are based on data from other viral outbreaks, like H1N1 and SARS-CoV, as well as other medical conditions, like nonviral acute respiratory distress syndrome and sepsis. The researchers did not conduct a randomized controlled trial of MATH+ for patients with COVID-19 because, as they write in the article, they did not believe they had the clinical equipoise required for such a study.
“With respect to each of the individual ‘core’ therapies of MATH+, all authors felt the therapies either superior to any placebo or possessed evidence of minimal risk and cost compared to potential benefit,” they wrote in the paper.
“With a new disease, it is totally reasonable to take your best guess at a therapy,” wrote F. Perry Wilson, MD, MSCE, director of the Clinical and Translational Research Accelerator at Yale University School of Medicine, in an email to Medscape. “When there is limited information, you go with what you have. What I take issue with here is the authors’ implication that that’s where the scientific process stops. In my mind, it’s actually just the beginning.” Every investigator believes his or her intervention is beneficial but is not sure — that’s why they conduct a randomized controlled trial, Wilson said.
“Without robust trials, we are left with too many options on the table and no way to know what helps — leading to this ‘throw the book at them’ approach, where you just pick your favorite molecule and give it,” said Wilson.
Sam Parnia, MD, PhD, associate professor of medicine and director of critical care and resuscitation research at NYU Langone, echoed this sentiment: “Many of the individual components could be expected to provide benefit and combining therapies is something physicians often do,” Parnia said in an email to Medscape. “I think this is a promising approach; however, this ultimately needs to be studied.”
: United Memorial Hospital in Houston, Texas and Norfolk General Hospital in Norfolk, Virginia. At United Memorial, MATH+ was “systematically” followed for patients admitted to the hospital, and at Norfolk General it was followed for patients admitted to the ICU. The two hospitals treated 140 and 191 COVID-19 patients with MATH+, respectively, as of July 20.
The average observed hospital or 28-day mortality rate at United Memorial was 4.4% and at Norfolk General was 6.1%, for a combined mortality rate of 5.1%. The researchers compared this rate with reported outcomes from 10 studies of more than 400 hospitals in the United States (72 hospitals), the United Kingdom (386), and China (3). The mortality rate for COVID-19 patients at these hospitals ranged from 15.6% to 32%, for an average mortality rate of 22.9%.
The difference in average mortality rates represents a “more than 75% absolute risk reduction in mortality” with MATH+, according to the authors. The data from other hospitals were reported from January to early June, representative of death rates early in the pandemic and before the announcement of the RECOVERY trial results spurred increased use of dexamethasone.
The new numbers may not be convincing to other physicians.
“The comparison of the outcomes in the two hospitals where this protocol is implemented vs mortality rates in other published studies is quite a stretch,” Wilson told Medscape. “Hospitals with robust research programs that publish large cohorts tend to be tertiary care centers where sick patients get referred. Without data on the baseline characteristics of the patients in these studies, it’s really not appropriate to draw apples-to-apples comparisons.”
“There are many factors that lead to different mortality rates [between hospitals] and it often reflects the quality of general ICU care,” said Parnia. For example, many ICUs were overwhelmed and stretched during the pandemic, while others were not.
“This protocol remains a hypothesis in need of a prospective clinical trial,” said Daniel Kaul, MD, professor of infectious diseases at the University of Michigan, Ann Arbor. “Comparing gross mortality rates from different centers at different times with different case mixes is at most hypothesis generating.”
“The use of comparative data is useless information…not based on true comparison of groups,” said Cassiere of the average mortality rates. Only a randomized, placebo-controlled trial can prove if a treatment is effective. “This protocol should be abandoned.”
“The MATH+ is based on negative evidence,” Cassiere told Medscape, pointing to trials that showed no effect for vitamin C (ascorbic acid) and thiamine in critical illnesses. And, given the “overwhelming positive data’’ for dexamethasone to treat patients with severe COVID-19, its exclusion from MATH+ in favor of a steroid that has not been extensively studied for COVID-19 is “reckless and irresponsible,” he said.
Kory pushed back strongly against this assertion, pointing to the decades of research on methylprednisolone as a treatment for lung disease and ARDS outlined in the article. “It has far more evidence than dexamethasone,” he told Medscape over the phone.
“Our recommendation is based on a clear understanding of the pharmacological principle to guide prolonged glucocorticoid administration in ARDS and COVID-19,” wrote G. Umberto Meduri, MD, a MATH+ coauthor and professor in the Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Tennessee Health Science Center in Memphis.
A version of this article first appeared on Medscape.com.
The top pediatric articles of 2019
Updates in pediatric hospital medicine
The expansion of the field of pediatric hospital medicine in the past 30 years has resulted in improved health care outcomes for hospitalized children1,2 and has been accompanied by a robust increase in the amount of scholarly work related to the field.3 We performed a review of the literature published in 2019 to identify the 10 articles that had the most impact on pediatric hospital medicine, and presented the findings at HM20 Virtual, the 2020 annual conference of the Society of Hospital Medicine. Five of the selected articles are highlighted here.
STUDY 1
Wechsler ME et al. Step-up therapy in black children and adults with poorly controlled asthma. N Engl J Med. 2019 Sep 26;381(13):1227-39.
Background
Current pediatric asthma guidelines suggest adding a long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) therapy, rather than increasing the ICS dose, for children with poorly controlled asthma. However, these data are based on trials with disproportionately few Black subjects. This study aimed to determine the best step-up therapy for Black patients whose asthma was poorly controlled on ICS monotherapy.
Study overview and results
The authors reported two parallel double-blind, randomized, controlled trials, one in children and one in adolescents and adults. The study of children included 280 subjects ranging in age from 5 to 11, with at least one Black grandparent, and with poorly controlled asthma on low-dose ICS therapy. It used a four-way crossover design in which each subject was treated with four different 14-week treatment regimens: either double (medium-dose) or quintuple (high-dose) their baseline ICS dose, with or without the addition of a LABA. A superior response was defined by the composite outcome of at least one fewer asthma exacerbation, more asthma-control days, or a 5–percentage point difference in predicted FEV1. Forty-six percent of children had improved asthma outcomes when the ICS dose was increased rather than with the addition of a LABA. In contrast, Black adolescents and Black adults had superior responses to the addition of a LABA. There was no significant interaction between the percentage of African ancestry as determined by DNA genotyping and the primary composite outcome. High-dose ICS was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years.
Limitations
Approximately 25% of children dropped out of the study, with disproportionately more children dropping out while on a high-dose ICS regimen. Additionally, the difference in the composite outcome was primarily driven by differences in FEV1, with few subjects demonstrating a difference in asthma exacerbations or asthma-control days. Although a decrease in urinary cortisol to creatinine ratio was noted in children under 8 on high-dose ICS, the study period was not long enough to determine the clinical implications of this finding.
Important findings and implications
While studies with a majority of white children have suggested a superior response from adding a LABA compared to increasing the dose of an ICS, almost half of Black children showed a superior response when the dose of an ICS was increased rather than adding a LABA. It is important to note that current guidelines are based on studies with a disproportionate majority of white subjects and may not accurately reflect optimal care for patients in other racial groups. This study underscores the need to include a diverse patient population in research studies.
STUDY 2
Chang PW, Newman TB. A simpler prediction rule for rebound hyperbilirubinemia. Pediatrics. 2019 Jul;144(1):e20183712.
Background
Hyperbilirubinemia (jaundice) is estimated to affect 50%-60% of all newborns. Rebound hyperbilirubinemia – a rise in bilirubin after cessation of phototherapy – is common and can lead to recently discharged infants being readmitted for additional therapy. Lack of clear guidelines regarding when to discharge infants with hyperbilirubinemia has likely contributed to practice variation and some trepidation regarding whether a bilirubin level is “low enough” to discontinue therapy.
Study overview and results
The authors had previously proposed a three-factor hyperbilirubinemia risk model and sought to simplify their rule further.4 They examined a retrospective cohort of 7,048 infants greater than or equal to 35 weeks’ gestation using a random split sample. The authors derived a two-factor model using the same methods and compared its performance to the three-factor model. The two-factor formula was shown to be a good fit as a logistic regression model (Hosmer-Lemeshow test 9.21; P = .33), and the AUROC (area under the receiver operating characteristic) curves for the derivation and validation cohorts were similar between the two-factor (0.877 and 0.876, respectively) and three-factor risk models (0.887 and 0.881, respectively).
Limitations
These data are limited to infants receiving their first treatment of phototherapy and have not been externally validated. An important variable, serum bilirubin at phototherapy termination, was estimated in most subjects, which may have affected the accuracy of the prediction rule. Whether infants received home phototherapy was based only on equipment orders, and some infants may have received phototherapy unbeknownst to investigators. Last, infants with rebound hyperbilirubinemia at less than 72 hours after phototherapy discontinuation may have been missed.
Important findings and implications
This prediction model provides evidence-based, concrete data that can be used in making joint decisions with families regarding discharge timing of infants with hyperbilirubinemia. It also could be beneficial when deciding appropriate follow-up time after discharge.
STUDY 3
Ramgopal S et al. Risk of serious bacterial infection in infants aged ≤60 days presenting to emergency departments with a history of fever only. J Pediatr. 2019 Jan;204:191-195. doi: 10.1016/j.jpeds.2018.08.043.
Background
Febrile infants aged 60 days and younger are at risk for serious bacterial infections (SBI) including urinary tract infections (UTI), bacteremia, and meningitis. As physical exam is a poor discriminator of SBI in this age group, providers frequently rely on laboratory values and risk factors to guide management. Infants presenting with documented fevers by caregivers but found to have no fever in the emergency department are a challenge, and there are limited data regarding SBI frequency in this population.
Study overview and results
The authors performed a secondary analysis of a prospectively gathered cohort of infants aged 60 days and younger within the Pediatric Emergency Care Applied Research Network (PECARN) who had blood, urine, and CSF data available. Notable exclusions included infants who were premature, had a focal infection, were clinically ill, had recent antibiotic use, did not have blood, urine, and CSF data available, or were lost to telephone follow-up at 7 days to ensure wellness. The study cohort included 6,014 infants, 1,233 (32%) who were febrile by history alone. Rates of overall SBI were lower in the afebrile group (8.8% vs. 12.8%). For infants 0-28 days, rates of UTI were lower for the afebrile group (9.5% vs. 14.5%), but there was no difference in the rates of bacteremia or meningitis. For infants 29-60 days, rates of UTI (6.6% vs. 9.3%) and bacteremia (.5% vs. 1.7%) were lower in the afebrile group.
Limitations
Neither the use of home antipyretics nor the method of temperature taking at home were studied. Also, as this was a secondary analysis, it is possible that not all infants who presented with history of fever only were captured, as work-up was dictated by individual treating providers who may have chosen not to work up certain afebrile infants.
Important findings and implications
Nearly one-third of infants presenting for fever evaluation are afebrile on arrival. Although overall rates of SBI were lower in the group with fever by history only, this difference is largely accounted for by differing rates of UTI. Rates of bacteremia and meningitis remained substantial between groups, particularly for infants aged 0-28 days. Because of the significant morbidity associated with these infections, it is reasonable to suggest that absence of fever on presentation alone should not alter clinical or laboratory work-up, particularly in infants 0-28 days.
STUDY 4
Humphrey-Murto S et al. The influence of prior performance information on ratings of current performance and implications for learner handover: A scoping review. Acad Med. 2019 Jul;94(7):1050-7.
Background
Learner Handover (LH) or “forward feeding” occurs when information about trainees is shared between faculty supervisors. Although this can be helpful to tailor educational experiences and build upon previous assessments, it risks stigmatizing trainees and adding bias to future feedback and assessments as the trainee never really has a “clean slate.” In this study, the authors sought to uncover the key concepts of how prior performance information (PPI) influences assessments and any implications for medical education.
Study overview and results
The authors performed a cross-disciplinary scoping review looking at over 17,000 articles published between 1980 and 2017 across the domains of psychology, sports, business, and education. Seven themes were identified with the following notable findings. Raters exposed to positive PPI scored a learner’s performance higher, and vice versa. There was a dose-response relationship with more positive and more negative PPI resulting in higher and lower assessments, respectively. General standards, such as a direction to complete all work in a timely manner, caused an assimilation effect, while specific standards, such as a direction to complete a certain task by a certain day, did not. More motivated and more experienced raters are less affected by PPI, and those who believe that people can change (incremental theorists) are less affected by PPI while those who believe personal attributes are fixed (entity theorists) are more affected.
Limitations
The heterogeneity of the studies and the fact that they were largely conducted in experimental settings may limit generalizability to medical education. Slightly less than half of the studies included a control arm. Last, most of the studies looked at the ratings of only one target performance, not multiple performances over time.
Important findings and implications
Ratings of current performance displace toward PPI direction, with negative PPI more influential than positive PPI. In a formative setting, PPI may help the assessor focus on areas of possible weakness. In contrast, for a summative assessment, PPI may be prejudicial and have an impact on the rating given to the student. Clinicians should be mindful of the information they share with future raters about learners and the potential bias on future assessments that can manifest as a result.
STUDY 5
McCann ME et al. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): An international, multicentre, randomised, controlled equivalence trial. The Lancet. 2019 Feb;393:664-77.
Background
Animal models and observational studies have suggested a link between early anesthesia exposure and adverse neurocognitive outcomes; however, findings have been mixed and studies are prone to confounding. This study is the first randomized controlled trial to compare neurocognitive outcomes for infants exposed to general anesthesia versus awake-regional anesthesia.
Study overview and results
In this international, multicenter, assessor-masked trial, 722 infants undergoing inguinal hernia repair were randomized to awake-regional anesthesia or single-agent sevoflurane-based general anesthesia. Infants born at greater than 26 weeks’ gestational age were eligible, while those with prior anesthesia exposure or risks for neurocognitive delay were excluded. The primary outcome was full-scale intelligence quotient (FSIQ) testing at 5 years of age on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III). Seven additional neurodevelopmental assessments and parental questionnaires regarding behavior were administered as secondary outcomes. Average anesthesia exposure was 54 minutes and no infant had exposure greater than 120 minutes. There was no significant difference in mean scores on WPPSI-III FSIQ testing, and no difference in the additional neurocognitive assessments or parent-reported outcomes used as secondary outcomes.
Limitations
This study was limited to single, short periods of single-agent anesthesia exposure in children with no additional neurologic risk factors, so caution should be used in extrapolating these data to children with medical complexity and children undergoing multiple procedures, longer surgeries, or multidrug anesthetic regimens. The study population was majority male because of the surgical pathology selected and included only children in the narrow range of postmenstrual age 60 weeks or less. While this population represents a suspected a period of high cerebral vulnerability based on animal models, the implications of anesthesia exposure at other ages are unclear.
Important findings and implications
An estimated 10% of children from developed countries are exposed to general anesthesia during the first 3 years of life. While hospitalists do not typically select the route of anesthesia, they frequently care for patients undergoing procedures and must address parental concerns regarding the safety of anesthesia exposure. Given the rigorous study methods and long-term follow up in the current study, these data should provide reassurance that, for healthy infants undergoing short, single-agent anesthetic exposure, there is no evidence of future adverse neurologic outcomes.
Dr. Russo is director of pediatrics, medical director for quality and innovation, at WellSpan Health, York, Pa. Dr. Money is a pediatric hospitalist at Primary Children’s Hospital, University of Utah School of Medicine, Salt Lake City. Dr. Steed is instructor of hospital medicine, Northwestern Memorial Hospital and Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University School of Medicine, Chicago. The authors would like to thank Dr. Klint M. Schwenk and the Society for Hospital Medicine Pediatric Special Interest Group Executive Council.
References
1. Roberts KB, Fisher ER, and Rauch DA. The history of pediatric hospital medicine in the United States, 1996-2019. J Hosp Med. 2020 Jul;15(7):424-7.
2. Mussman GM and Conway PH. Pediatric hospitalist systems versus traditional models of care: Effect on quality and cost outcomes. J Hosp Med. 2012 Apr;7(4):350-7.
3. Wang ME, Shaughnessy EE, and Leyenaar JK. The future of pediatric hospital medicine: Challenges and opportunities. J Hosp Med. 2020 Jul;15(7):428-30.
4. Chang PW et al. A clinical prediction rule for rebound hyperbilirubinemia following inpatient phototherapy. Pediatrics. 2017;139 Mar;139(3):e20162896.
Updates in pediatric hospital medicine
Updates in pediatric hospital medicine
The expansion of the field of pediatric hospital medicine in the past 30 years has resulted in improved health care outcomes for hospitalized children1,2 and has been accompanied by a robust increase in the amount of scholarly work related to the field.3 We performed a review of the literature published in 2019 to identify the 10 articles that had the most impact on pediatric hospital medicine, and presented the findings at HM20 Virtual, the 2020 annual conference of the Society of Hospital Medicine. Five of the selected articles are highlighted here.
STUDY 1
Wechsler ME et al. Step-up therapy in black children and adults with poorly controlled asthma. N Engl J Med. 2019 Sep 26;381(13):1227-39.
Background
Current pediatric asthma guidelines suggest adding a long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) therapy, rather than increasing the ICS dose, for children with poorly controlled asthma. However, these data are based on trials with disproportionately few Black subjects. This study aimed to determine the best step-up therapy for Black patients whose asthma was poorly controlled on ICS monotherapy.
Study overview and results
The authors reported two parallel double-blind, randomized, controlled trials, one in children and one in adolescents and adults. The study of children included 280 subjects ranging in age from 5 to 11, with at least one Black grandparent, and with poorly controlled asthma on low-dose ICS therapy. It used a four-way crossover design in which each subject was treated with four different 14-week treatment regimens: either double (medium-dose) or quintuple (high-dose) their baseline ICS dose, with or without the addition of a LABA. A superior response was defined by the composite outcome of at least one fewer asthma exacerbation, more asthma-control days, or a 5–percentage point difference in predicted FEV1. Forty-six percent of children had improved asthma outcomes when the ICS dose was increased rather than with the addition of a LABA. In contrast, Black adolescents and Black adults had superior responses to the addition of a LABA. There was no significant interaction between the percentage of African ancestry as determined by DNA genotyping and the primary composite outcome. High-dose ICS was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years.
Limitations
Approximately 25% of children dropped out of the study, with disproportionately more children dropping out while on a high-dose ICS regimen. Additionally, the difference in the composite outcome was primarily driven by differences in FEV1, with few subjects demonstrating a difference in asthma exacerbations or asthma-control days. Although a decrease in urinary cortisol to creatinine ratio was noted in children under 8 on high-dose ICS, the study period was not long enough to determine the clinical implications of this finding.
Important findings and implications
While studies with a majority of white children have suggested a superior response from adding a LABA compared to increasing the dose of an ICS, almost half of Black children showed a superior response when the dose of an ICS was increased rather than adding a LABA. It is important to note that current guidelines are based on studies with a disproportionate majority of white subjects and may not accurately reflect optimal care for patients in other racial groups. This study underscores the need to include a diverse patient population in research studies.
STUDY 2
Chang PW, Newman TB. A simpler prediction rule for rebound hyperbilirubinemia. Pediatrics. 2019 Jul;144(1):e20183712.
Background
Hyperbilirubinemia (jaundice) is estimated to affect 50%-60% of all newborns. Rebound hyperbilirubinemia – a rise in bilirubin after cessation of phototherapy – is common and can lead to recently discharged infants being readmitted for additional therapy. Lack of clear guidelines regarding when to discharge infants with hyperbilirubinemia has likely contributed to practice variation and some trepidation regarding whether a bilirubin level is “low enough” to discontinue therapy.
Study overview and results
The authors had previously proposed a three-factor hyperbilirubinemia risk model and sought to simplify their rule further.4 They examined a retrospective cohort of 7,048 infants greater than or equal to 35 weeks’ gestation using a random split sample. The authors derived a two-factor model using the same methods and compared its performance to the three-factor model. The two-factor formula was shown to be a good fit as a logistic regression model (Hosmer-Lemeshow test 9.21; P = .33), and the AUROC (area under the receiver operating characteristic) curves for the derivation and validation cohorts were similar between the two-factor (0.877 and 0.876, respectively) and three-factor risk models (0.887 and 0.881, respectively).
Limitations
These data are limited to infants receiving their first treatment of phototherapy and have not been externally validated. An important variable, serum bilirubin at phototherapy termination, was estimated in most subjects, which may have affected the accuracy of the prediction rule. Whether infants received home phototherapy was based only on equipment orders, and some infants may have received phototherapy unbeknownst to investigators. Last, infants with rebound hyperbilirubinemia at less than 72 hours after phototherapy discontinuation may have been missed.
Important findings and implications
This prediction model provides evidence-based, concrete data that can be used in making joint decisions with families regarding discharge timing of infants with hyperbilirubinemia. It also could be beneficial when deciding appropriate follow-up time after discharge.
STUDY 3
Ramgopal S et al. Risk of serious bacterial infection in infants aged ≤60 days presenting to emergency departments with a history of fever only. J Pediatr. 2019 Jan;204:191-195. doi: 10.1016/j.jpeds.2018.08.043.
Background
Febrile infants aged 60 days and younger are at risk for serious bacterial infections (SBI) including urinary tract infections (UTI), bacteremia, and meningitis. As physical exam is a poor discriminator of SBI in this age group, providers frequently rely on laboratory values and risk factors to guide management. Infants presenting with documented fevers by caregivers but found to have no fever in the emergency department are a challenge, and there are limited data regarding SBI frequency in this population.
Study overview and results
The authors performed a secondary analysis of a prospectively gathered cohort of infants aged 60 days and younger within the Pediatric Emergency Care Applied Research Network (PECARN) who had blood, urine, and CSF data available. Notable exclusions included infants who were premature, had a focal infection, were clinically ill, had recent antibiotic use, did not have blood, urine, and CSF data available, or were lost to telephone follow-up at 7 days to ensure wellness. The study cohort included 6,014 infants, 1,233 (32%) who were febrile by history alone. Rates of overall SBI were lower in the afebrile group (8.8% vs. 12.8%). For infants 0-28 days, rates of UTI were lower for the afebrile group (9.5% vs. 14.5%), but there was no difference in the rates of bacteremia or meningitis. For infants 29-60 days, rates of UTI (6.6% vs. 9.3%) and bacteremia (.5% vs. 1.7%) were lower in the afebrile group.
Limitations
Neither the use of home antipyretics nor the method of temperature taking at home were studied. Also, as this was a secondary analysis, it is possible that not all infants who presented with history of fever only were captured, as work-up was dictated by individual treating providers who may have chosen not to work up certain afebrile infants.
Important findings and implications
Nearly one-third of infants presenting for fever evaluation are afebrile on arrival. Although overall rates of SBI were lower in the group with fever by history only, this difference is largely accounted for by differing rates of UTI. Rates of bacteremia and meningitis remained substantial between groups, particularly for infants aged 0-28 days. Because of the significant morbidity associated with these infections, it is reasonable to suggest that absence of fever on presentation alone should not alter clinical or laboratory work-up, particularly in infants 0-28 days.
STUDY 4
Humphrey-Murto S et al. The influence of prior performance information on ratings of current performance and implications for learner handover: A scoping review. Acad Med. 2019 Jul;94(7):1050-7.
Background
Learner Handover (LH) or “forward feeding” occurs when information about trainees is shared between faculty supervisors. Although this can be helpful to tailor educational experiences and build upon previous assessments, it risks stigmatizing trainees and adding bias to future feedback and assessments as the trainee never really has a “clean slate.” In this study, the authors sought to uncover the key concepts of how prior performance information (PPI) influences assessments and any implications for medical education.
Study overview and results
The authors performed a cross-disciplinary scoping review looking at over 17,000 articles published between 1980 and 2017 across the domains of psychology, sports, business, and education. Seven themes were identified with the following notable findings. Raters exposed to positive PPI scored a learner’s performance higher, and vice versa. There was a dose-response relationship with more positive and more negative PPI resulting in higher and lower assessments, respectively. General standards, such as a direction to complete all work in a timely manner, caused an assimilation effect, while specific standards, such as a direction to complete a certain task by a certain day, did not. More motivated and more experienced raters are less affected by PPI, and those who believe that people can change (incremental theorists) are less affected by PPI while those who believe personal attributes are fixed (entity theorists) are more affected.
Limitations
The heterogeneity of the studies and the fact that they were largely conducted in experimental settings may limit generalizability to medical education. Slightly less than half of the studies included a control arm. Last, most of the studies looked at the ratings of only one target performance, not multiple performances over time.
Important findings and implications
Ratings of current performance displace toward PPI direction, with negative PPI more influential than positive PPI. In a formative setting, PPI may help the assessor focus on areas of possible weakness. In contrast, for a summative assessment, PPI may be prejudicial and have an impact on the rating given to the student. Clinicians should be mindful of the information they share with future raters about learners and the potential bias on future assessments that can manifest as a result.
STUDY 5
McCann ME et al. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): An international, multicentre, randomised, controlled equivalence trial. The Lancet. 2019 Feb;393:664-77.
Background
Animal models and observational studies have suggested a link between early anesthesia exposure and adverse neurocognitive outcomes; however, findings have been mixed and studies are prone to confounding. This study is the first randomized controlled trial to compare neurocognitive outcomes for infants exposed to general anesthesia versus awake-regional anesthesia.
Study overview and results
In this international, multicenter, assessor-masked trial, 722 infants undergoing inguinal hernia repair were randomized to awake-regional anesthesia or single-agent sevoflurane-based general anesthesia. Infants born at greater than 26 weeks’ gestational age were eligible, while those with prior anesthesia exposure or risks for neurocognitive delay were excluded. The primary outcome was full-scale intelligence quotient (FSIQ) testing at 5 years of age on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III). Seven additional neurodevelopmental assessments and parental questionnaires regarding behavior were administered as secondary outcomes. Average anesthesia exposure was 54 minutes and no infant had exposure greater than 120 minutes. There was no significant difference in mean scores on WPPSI-III FSIQ testing, and no difference in the additional neurocognitive assessments or parent-reported outcomes used as secondary outcomes.
Limitations
This study was limited to single, short periods of single-agent anesthesia exposure in children with no additional neurologic risk factors, so caution should be used in extrapolating these data to children with medical complexity and children undergoing multiple procedures, longer surgeries, or multidrug anesthetic regimens. The study population was majority male because of the surgical pathology selected and included only children in the narrow range of postmenstrual age 60 weeks or less. While this population represents a suspected a period of high cerebral vulnerability based on animal models, the implications of anesthesia exposure at other ages are unclear.
Important findings and implications
An estimated 10% of children from developed countries are exposed to general anesthesia during the first 3 years of life. While hospitalists do not typically select the route of anesthesia, they frequently care for patients undergoing procedures and must address parental concerns regarding the safety of anesthesia exposure. Given the rigorous study methods and long-term follow up in the current study, these data should provide reassurance that, for healthy infants undergoing short, single-agent anesthetic exposure, there is no evidence of future adverse neurologic outcomes.
Dr. Russo is director of pediatrics, medical director for quality and innovation, at WellSpan Health, York, Pa. Dr. Money is a pediatric hospitalist at Primary Children’s Hospital, University of Utah School of Medicine, Salt Lake City. Dr. Steed is instructor of hospital medicine, Northwestern Memorial Hospital and Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University School of Medicine, Chicago. The authors would like to thank Dr. Klint M. Schwenk and the Society for Hospital Medicine Pediatric Special Interest Group Executive Council.
References
1. Roberts KB, Fisher ER, and Rauch DA. The history of pediatric hospital medicine in the United States, 1996-2019. J Hosp Med. 2020 Jul;15(7):424-7.
2. Mussman GM and Conway PH. Pediatric hospitalist systems versus traditional models of care: Effect on quality and cost outcomes. J Hosp Med. 2012 Apr;7(4):350-7.
3. Wang ME, Shaughnessy EE, and Leyenaar JK. The future of pediatric hospital medicine: Challenges and opportunities. J Hosp Med. 2020 Jul;15(7):428-30.
4. Chang PW et al. A clinical prediction rule for rebound hyperbilirubinemia following inpatient phototherapy. Pediatrics. 2017;139 Mar;139(3):e20162896.
The expansion of the field of pediatric hospital medicine in the past 30 years has resulted in improved health care outcomes for hospitalized children1,2 and has been accompanied by a robust increase in the amount of scholarly work related to the field.3 We performed a review of the literature published in 2019 to identify the 10 articles that had the most impact on pediatric hospital medicine, and presented the findings at HM20 Virtual, the 2020 annual conference of the Society of Hospital Medicine. Five of the selected articles are highlighted here.
STUDY 1
Wechsler ME et al. Step-up therapy in black children and adults with poorly controlled asthma. N Engl J Med. 2019 Sep 26;381(13):1227-39.
Background
Current pediatric asthma guidelines suggest adding a long-acting beta-agonist (LABA) to inhaled corticosteroid (ICS) therapy, rather than increasing the ICS dose, for children with poorly controlled asthma. However, these data are based on trials with disproportionately few Black subjects. This study aimed to determine the best step-up therapy for Black patients whose asthma was poorly controlled on ICS monotherapy.
Study overview and results
The authors reported two parallel double-blind, randomized, controlled trials, one in children and one in adolescents and adults. The study of children included 280 subjects ranging in age from 5 to 11, with at least one Black grandparent, and with poorly controlled asthma on low-dose ICS therapy. It used a four-way crossover design in which each subject was treated with four different 14-week treatment regimens: either double (medium-dose) or quintuple (high-dose) their baseline ICS dose, with or without the addition of a LABA. A superior response was defined by the composite outcome of at least one fewer asthma exacerbation, more asthma-control days, or a 5–percentage point difference in predicted FEV1. Forty-six percent of children had improved asthma outcomes when the ICS dose was increased rather than with the addition of a LABA. In contrast, Black adolescents and Black adults had superior responses to the addition of a LABA. There was no significant interaction between the percentage of African ancestry as determined by DNA genotyping and the primary composite outcome. High-dose ICS was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years.
Limitations
Approximately 25% of children dropped out of the study, with disproportionately more children dropping out while on a high-dose ICS regimen. Additionally, the difference in the composite outcome was primarily driven by differences in FEV1, with few subjects demonstrating a difference in asthma exacerbations or asthma-control days. Although a decrease in urinary cortisol to creatinine ratio was noted in children under 8 on high-dose ICS, the study period was not long enough to determine the clinical implications of this finding.
Important findings and implications
While studies with a majority of white children have suggested a superior response from adding a LABA compared to increasing the dose of an ICS, almost half of Black children showed a superior response when the dose of an ICS was increased rather than adding a LABA. It is important to note that current guidelines are based on studies with a disproportionate majority of white subjects and may not accurately reflect optimal care for patients in other racial groups. This study underscores the need to include a diverse patient population in research studies.
STUDY 2
Chang PW, Newman TB. A simpler prediction rule for rebound hyperbilirubinemia. Pediatrics. 2019 Jul;144(1):e20183712.
Background
Hyperbilirubinemia (jaundice) is estimated to affect 50%-60% of all newborns. Rebound hyperbilirubinemia – a rise in bilirubin after cessation of phototherapy – is common and can lead to recently discharged infants being readmitted for additional therapy. Lack of clear guidelines regarding when to discharge infants with hyperbilirubinemia has likely contributed to practice variation and some trepidation regarding whether a bilirubin level is “low enough” to discontinue therapy.
Study overview and results
The authors had previously proposed a three-factor hyperbilirubinemia risk model and sought to simplify their rule further.4 They examined a retrospective cohort of 7,048 infants greater than or equal to 35 weeks’ gestation using a random split sample. The authors derived a two-factor model using the same methods and compared its performance to the three-factor model. The two-factor formula was shown to be a good fit as a logistic regression model (Hosmer-Lemeshow test 9.21; P = .33), and the AUROC (area under the receiver operating characteristic) curves for the derivation and validation cohorts were similar between the two-factor (0.877 and 0.876, respectively) and three-factor risk models (0.887 and 0.881, respectively).
Limitations
These data are limited to infants receiving their first treatment of phototherapy and have not been externally validated. An important variable, serum bilirubin at phototherapy termination, was estimated in most subjects, which may have affected the accuracy of the prediction rule. Whether infants received home phototherapy was based only on equipment orders, and some infants may have received phototherapy unbeknownst to investigators. Last, infants with rebound hyperbilirubinemia at less than 72 hours after phototherapy discontinuation may have been missed.
Important findings and implications
This prediction model provides evidence-based, concrete data that can be used in making joint decisions with families regarding discharge timing of infants with hyperbilirubinemia. It also could be beneficial when deciding appropriate follow-up time after discharge.
STUDY 3
Ramgopal S et al. Risk of serious bacterial infection in infants aged ≤60 days presenting to emergency departments with a history of fever only. J Pediatr. 2019 Jan;204:191-195. doi: 10.1016/j.jpeds.2018.08.043.
Background
Febrile infants aged 60 days and younger are at risk for serious bacterial infections (SBI) including urinary tract infections (UTI), bacteremia, and meningitis. As physical exam is a poor discriminator of SBI in this age group, providers frequently rely on laboratory values and risk factors to guide management. Infants presenting with documented fevers by caregivers but found to have no fever in the emergency department are a challenge, and there are limited data regarding SBI frequency in this population.
Study overview and results
The authors performed a secondary analysis of a prospectively gathered cohort of infants aged 60 days and younger within the Pediatric Emergency Care Applied Research Network (PECARN) who had blood, urine, and CSF data available. Notable exclusions included infants who were premature, had a focal infection, were clinically ill, had recent antibiotic use, did not have blood, urine, and CSF data available, or were lost to telephone follow-up at 7 days to ensure wellness. The study cohort included 6,014 infants, 1,233 (32%) who were febrile by history alone. Rates of overall SBI were lower in the afebrile group (8.8% vs. 12.8%). For infants 0-28 days, rates of UTI were lower for the afebrile group (9.5% vs. 14.5%), but there was no difference in the rates of bacteremia or meningitis. For infants 29-60 days, rates of UTI (6.6% vs. 9.3%) and bacteremia (.5% vs. 1.7%) were lower in the afebrile group.
Limitations
Neither the use of home antipyretics nor the method of temperature taking at home were studied. Also, as this was a secondary analysis, it is possible that not all infants who presented with history of fever only were captured, as work-up was dictated by individual treating providers who may have chosen not to work up certain afebrile infants.
Important findings and implications
Nearly one-third of infants presenting for fever evaluation are afebrile on arrival. Although overall rates of SBI were lower in the group with fever by history only, this difference is largely accounted for by differing rates of UTI. Rates of bacteremia and meningitis remained substantial between groups, particularly for infants aged 0-28 days. Because of the significant morbidity associated with these infections, it is reasonable to suggest that absence of fever on presentation alone should not alter clinical or laboratory work-up, particularly in infants 0-28 days.
STUDY 4
Humphrey-Murto S et al. The influence of prior performance information on ratings of current performance and implications for learner handover: A scoping review. Acad Med. 2019 Jul;94(7):1050-7.
Background
Learner Handover (LH) or “forward feeding” occurs when information about trainees is shared between faculty supervisors. Although this can be helpful to tailor educational experiences and build upon previous assessments, it risks stigmatizing trainees and adding bias to future feedback and assessments as the trainee never really has a “clean slate.” In this study, the authors sought to uncover the key concepts of how prior performance information (PPI) influences assessments and any implications for medical education.
Study overview and results
The authors performed a cross-disciplinary scoping review looking at over 17,000 articles published between 1980 and 2017 across the domains of psychology, sports, business, and education. Seven themes were identified with the following notable findings. Raters exposed to positive PPI scored a learner’s performance higher, and vice versa. There was a dose-response relationship with more positive and more negative PPI resulting in higher and lower assessments, respectively. General standards, such as a direction to complete all work in a timely manner, caused an assimilation effect, while specific standards, such as a direction to complete a certain task by a certain day, did not. More motivated and more experienced raters are less affected by PPI, and those who believe that people can change (incremental theorists) are less affected by PPI while those who believe personal attributes are fixed (entity theorists) are more affected.
Limitations
The heterogeneity of the studies and the fact that they were largely conducted in experimental settings may limit generalizability to medical education. Slightly less than half of the studies included a control arm. Last, most of the studies looked at the ratings of only one target performance, not multiple performances over time.
Important findings and implications
Ratings of current performance displace toward PPI direction, with negative PPI more influential than positive PPI. In a formative setting, PPI may help the assessor focus on areas of possible weakness. In contrast, for a summative assessment, PPI may be prejudicial and have an impact on the rating given to the student. Clinicians should be mindful of the information they share with future raters about learners and the potential bias on future assessments that can manifest as a result.
STUDY 5
McCann ME et al. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): An international, multicentre, randomised, controlled equivalence trial. The Lancet. 2019 Feb;393:664-77.
Background
Animal models and observational studies have suggested a link between early anesthesia exposure and adverse neurocognitive outcomes; however, findings have been mixed and studies are prone to confounding. This study is the first randomized controlled trial to compare neurocognitive outcomes for infants exposed to general anesthesia versus awake-regional anesthesia.
Study overview and results
In this international, multicenter, assessor-masked trial, 722 infants undergoing inguinal hernia repair were randomized to awake-regional anesthesia or single-agent sevoflurane-based general anesthesia. Infants born at greater than 26 weeks’ gestational age were eligible, while those with prior anesthesia exposure or risks for neurocognitive delay were excluded. The primary outcome was full-scale intelligence quotient (FSIQ) testing at 5 years of age on the Wechsler Preschool and Primary Scale of Intelligence, third edition (WPPSI-III). Seven additional neurodevelopmental assessments and parental questionnaires regarding behavior were administered as secondary outcomes. Average anesthesia exposure was 54 minutes and no infant had exposure greater than 120 minutes. There was no significant difference in mean scores on WPPSI-III FSIQ testing, and no difference in the additional neurocognitive assessments or parent-reported outcomes used as secondary outcomes.
Limitations
This study was limited to single, short periods of single-agent anesthesia exposure in children with no additional neurologic risk factors, so caution should be used in extrapolating these data to children with medical complexity and children undergoing multiple procedures, longer surgeries, or multidrug anesthetic regimens. The study population was majority male because of the surgical pathology selected and included only children in the narrow range of postmenstrual age 60 weeks or less. While this population represents a suspected a period of high cerebral vulnerability based on animal models, the implications of anesthesia exposure at other ages are unclear.
Important findings and implications
An estimated 10% of children from developed countries are exposed to general anesthesia during the first 3 years of life. While hospitalists do not typically select the route of anesthesia, they frequently care for patients undergoing procedures and must address parental concerns regarding the safety of anesthesia exposure. Given the rigorous study methods and long-term follow up in the current study, these data should provide reassurance that, for healthy infants undergoing short, single-agent anesthetic exposure, there is no evidence of future adverse neurologic outcomes.
Dr. Russo is director of pediatrics, medical director for quality and innovation, at WellSpan Health, York, Pa. Dr. Money is a pediatric hospitalist at Primary Children’s Hospital, University of Utah School of Medicine, Salt Lake City. Dr. Steed is instructor of hospital medicine, Northwestern Memorial Hospital and Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University School of Medicine, Chicago. The authors would like to thank Dr. Klint M. Schwenk and the Society for Hospital Medicine Pediatric Special Interest Group Executive Council.
References
1. Roberts KB, Fisher ER, and Rauch DA. The history of pediatric hospital medicine in the United States, 1996-2019. J Hosp Med. 2020 Jul;15(7):424-7.
2. Mussman GM and Conway PH. Pediatric hospitalist systems versus traditional models of care: Effect on quality and cost outcomes. J Hosp Med. 2012 Apr;7(4):350-7.
3. Wang ME, Shaughnessy EE, and Leyenaar JK. The future of pediatric hospital medicine: Challenges and opportunities. J Hosp Med. 2020 Jul;15(7):428-30.
4. Chang PW et al. A clinical prediction rule for rebound hyperbilirubinemia following inpatient phototherapy. Pediatrics. 2017;139 Mar;139(3):e20162896.
Weight loss may be paramount lifestyle change in preventing gout
A recent analysis of the incidence of gout in men, published in JAMA Network Open, offers new insights on the role of lifestyle changes in preventing gout, particularly the importance of obesity and its modification.
Prior gout research, although it addressed lifestyle issues, had not quantified the impact of obesity on incident gout cases, noted first author Natalie McCormick, PhD, and colleagues at Harvard Medical School and Massachusetts General Hospital in Boston. “To date the proportion of actual gout itself that could potentially be prevented by modifying such risk factors remains unknown.” To address that lack of data, they set out to estimate the proportion of avoidable incident gout in a large database in the Health Professionals Follow-up Study, initially of some 51,529 male health professionals who have completed a biannual personal health questionnaire since 1986. The follow-up rate for completing these questionnaires exceeds 90%.
For their analysis, the researchers tracked 44,654 of these men, with an average age of 54 at the 1986 baseline and no history of gout, through the year 2012. They looked at four lifestyle risk factors attributed to gout: body mass index; alcohol intake; adherence to a Dietary Approach to Stop Hypertension (DASH)-style diet, which recommends less red meat and sweetened beverages and more fruits, vegetables, and low-fat dairy products; and the absence of diuretic drugs, which are used to treat blood pressure or heart failure, in order to observe and compare their effects on new reports of gout. Over the subsequent 26 years, nearly 4% of the men developed gout, the most common inflammatory arthritis. Obese men had 2.65 times greater risk for developing gout than did those with a normal body mass index.
If one addressed all four risk factors – modifying obesity, having no alcohol intake, not taking diuretic drugs, and following a DASH-style, lower-fat diet – 77% of new gout cases would disappear, the study’s corresponding author, Hyon K. Choi, MD, DrPH, of the division of rheumatology, allergy, and immunology at Massachusetts General Hospital, said in an interview. “But we learned that if you don’t include modifying obesity as a targetable risk factor, none of the other factors alone reaches significance. We can’t make firm conclusions about cause and effect, but modifying obesity seems to be a prerequisite to preventing gout through lifestyle. It’s a very interesting finding that needs to be confirmed in further research,” he said.
Of course, identifying the importance of lifestyle risk factors is not the same as actually achieving modifications of those factors. Changing lifestyle is difficult, Dr. Choi acknowledged. “But there’s not much potential for achieving the goal if the clinician doesn’t understand the target. Now we know obesity has a lot to do with gout. We can see it as a public health issue, especially since gout increases risks for comorbidities and mortality. All of these risk factors deserve intervention by the physician.”
A worldwide gout epidemic
Currently, there is a kind of worldwide gout epidemic linked to obesity, Dr. Choi said. The disease burden of gout is increasing worldwide. “This may be more of an issue for family practice or primary care physicians, who see 80%-90% of gout cases, rather than for rheumatologists, who are more likely to see advanced cases in need of drug therapy. But we would say: Don’t lose sight of the lifestyle risk factors, which are interrelated. This is not only the responsibility of one doctor or the other.”
The new findings should give practicing rheumatologists more confidence in addressing lifestyle issues, particularly weight loss, with their patients, said Angelo Gaffo, MD, section chief of rheumatology at the Birmingham VA Medical Center and associate professor of medicine in the division of rheumatology at the University of Alabama at Birmingham.
“Our patients with gout are interested in what they can do in their lives that might help with their gout. In the past, we’ve had generic advice about changing their diet. But in general, the evidence for the impact of dietary changes has not been strong.”
Doctors can now recommend a DASH-style diet, allowing room for moderate consumption of red meat, so long as patients are working on their weight loss – and showing results. “Now we have the information to give advice that’s more evidence-based,” Dr. Gaffo said. “You can ask the question whether this study is applicable to patients who already have gout. It doesn’t directly address them. But it mainly builds on the narrative that weight loss is important.”
Other studies have also looked at how weight loss led to serum urate reduction. This study adds to a growing body of literature emphasizing that the most important lifestyle factor relative to gout risk is weight gain, and the simplest, most effective intervention is counseling patients about weight loss, he said.
This research was supported by grants from the National Institutes of Health. Dr. Choi reported receiving research support from Ironwood and Horizon and consulting fees from Ironwood, Selecta, Horizon, Takeda, Kowa, and Vaxart. No other relevant financial disclosures were reported.
SOURCE: McCormick N et al. JAMA Netw Open. 2020;3(11):e2027421. doi: 10.1001/jamanetworkopen.2020.27421.
A recent analysis of the incidence of gout in men, published in JAMA Network Open, offers new insights on the role of lifestyle changes in preventing gout, particularly the importance of obesity and its modification.
Prior gout research, although it addressed lifestyle issues, had not quantified the impact of obesity on incident gout cases, noted first author Natalie McCormick, PhD, and colleagues at Harvard Medical School and Massachusetts General Hospital in Boston. “To date the proportion of actual gout itself that could potentially be prevented by modifying such risk factors remains unknown.” To address that lack of data, they set out to estimate the proportion of avoidable incident gout in a large database in the Health Professionals Follow-up Study, initially of some 51,529 male health professionals who have completed a biannual personal health questionnaire since 1986. The follow-up rate for completing these questionnaires exceeds 90%.
For their analysis, the researchers tracked 44,654 of these men, with an average age of 54 at the 1986 baseline and no history of gout, through the year 2012. They looked at four lifestyle risk factors attributed to gout: body mass index; alcohol intake; adherence to a Dietary Approach to Stop Hypertension (DASH)-style diet, which recommends less red meat and sweetened beverages and more fruits, vegetables, and low-fat dairy products; and the absence of diuretic drugs, which are used to treat blood pressure or heart failure, in order to observe and compare their effects on new reports of gout. Over the subsequent 26 years, nearly 4% of the men developed gout, the most common inflammatory arthritis. Obese men had 2.65 times greater risk for developing gout than did those with a normal body mass index.
If one addressed all four risk factors – modifying obesity, having no alcohol intake, not taking diuretic drugs, and following a DASH-style, lower-fat diet – 77% of new gout cases would disappear, the study’s corresponding author, Hyon K. Choi, MD, DrPH, of the division of rheumatology, allergy, and immunology at Massachusetts General Hospital, said in an interview. “But we learned that if you don’t include modifying obesity as a targetable risk factor, none of the other factors alone reaches significance. We can’t make firm conclusions about cause and effect, but modifying obesity seems to be a prerequisite to preventing gout through lifestyle. It’s a very interesting finding that needs to be confirmed in further research,” he said.
Of course, identifying the importance of lifestyle risk factors is not the same as actually achieving modifications of those factors. Changing lifestyle is difficult, Dr. Choi acknowledged. “But there’s not much potential for achieving the goal if the clinician doesn’t understand the target. Now we know obesity has a lot to do with gout. We can see it as a public health issue, especially since gout increases risks for comorbidities and mortality. All of these risk factors deserve intervention by the physician.”
A worldwide gout epidemic
Currently, there is a kind of worldwide gout epidemic linked to obesity, Dr. Choi said. The disease burden of gout is increasing worldwide. “This may be more of an issue for family practice or primary care physicians, who see 80%-90% of gout cases, rather than for rheumatologists, who are more likely to see advanced cases in need of drug therapy. But we would say: Don’t lose sight of the lifestyle risk factors, which are interrelated. This is not only the responsibility of one doctor or the other.”
The new findings should give practicing rheumatologists more confidence in addressing lifestyle issues, particularly weight loss, with their patients, said Angelo Gaffo, MD, section chief of rheumatology at the Birmingham VA Medical Center and associate professor of medicine in the division of rheumatology at the University of Alabama at Birmingham.
“Our patients with gout are interested in what they can do in their lives that might help with their gout. In the past, we’ve had generic advice about changing their diet. But in general, the evidence for the impact of dietary changes has not been strong.”
Doctors can now recommend a DASH-style diet, allowing room for moderate consumption of red meat, so long as patients are working on their weight loss – and showing results. “Now we have the information to give advice that’s more evidence-based,” Dr. Gaffo said. “You can ask the question whether this study is applicable to patients who already have gout. It doesn’t directly address them. But it mainly builds on the narrative that weight loss is important.”
Other studies have also looked at how weight loss led to serum urate reduction. This study adds to a growing body of literature emphasizing that the most important lifestyle factor relative to gout risk is weight gain, and the simplest, most effective intervention is counseling patients about weight loss, he said.
This research was supported by grants from the National Institutes of Health. Dr. Choi reported receiving research support from Ironwood and Horizon and consulting fees from Ironwood, Selecta, Horizon, Takeda, Kowa, and Vaxart. No other relevant financial disclosures were reported.
SOURCE: McCormick N et al. JAMA Netw Open. 2020;3(11):e2027421. doi: 10.1001/jamanetworkopen.2020.27421.
A recent analysis of the incidence of gout in men, published in JAMA Network Open, offers new insights on the role of lifestyle changes in preventing gout, particularly the importance of obesity and its modification.
Prior gout research, although it addressed lifestyle issues, had not quantified the impact of obesity on incident gout cases, noted first author Natalie McCormick, PhD, and colleagues at Harvard Medical School and Massachusetts General Hospital in Boston. “To date the proportion of actual gout itself that could potentially be prevented by modifying such risk factors remains unknown.” To address that lack of data, they set out to estimate the proportion of avoidable incident gout in a large database in the Health Professionals Follow-up Study, initially of some 51,529 male health professionals who have completed a biannual personal health questionnaire since 1986. The follow-up rate for completing these questionnaires exceeds 90%.
For their analysis, the researchers tracked 44,654 of these men, with an average age of 54 at the 1986 baseline and no history of gout, through the year 2012. They looked at four lifestyle risk factors attributed to gout: body mass index; alcohol intake; adherence to a Dietary Approach to Stop Hypertension (DASH)-style diet, which recommends less red meat and sweetened beverages and more fruits, vegetables, and low-fat dairy products; and the absence of diuretic drugs, which are used to treat blood pressure or heart failure, in order to observe and compare their effects on new reports of gout. Over the subsequent 26 years, nearly 4% of the men developed gout, the most common inflammatory arthritis. Obese men had 2.65 times greater risk for developing gout than did those with a normal body mass index.
If one addressed all four risk factors – modifying obesity, having no alcohol intake, not taking diuretic drugs, and following a DASH-style, lower-fat diet – 77% of new gout cases would disappear, the study’s corresponding author, Hyon K. Choi, MD, DrPH, of the division of rheumatology, allergy, and immunology at Massachusetts General Hospital, said in an interview. “But we learned that if you don’t include modifying obesity as a targetable risk factor, none of the other factors alone reaches significance. We can’t make firm conclusions about cause and effect, but modifying obesity seems to be a prerequisite to preventing gout through lifestyle. It’s a very interesting finding that needs to be confirmed in further research,” he said.
Of course, identifying the importance of lifestyle risk factors is not the same as actually achieving modifications of those factors. Changing lifestyle is difficult, Dr. Choi acknowledged. “But there’s not much potential for achieving the goal if the clinician doesn’t understand the target. Now we know obesity has a lot to do with gout. We can see it as a public health issue, especially since gout increases risks for comorbidities and mortality. All of these risk factors deserve intervention by the physician.”
A worldwide gout epidemic
Currently, there is a kind of worldwide gout epidemic linked to obesity, Dr. Choi said. The disease burden of gout is increasing worldwide. “This may be more of an issue for family practice or primary care physicians, who see 80%-90% of gout cases, rather than for rheumatologists, who are more likely to see advanced cases in need of drug therapy. But we would say: Don’t lose sight of the lifestyle risk factors, which are interrelated. This is not only the responsibility of one doctor or the other.”
The new findings should give practicing rheumatologists more confidence in addressing lifestyle issues, particularly weight loss, with their patients, said Angelo Gaffo, MD, section chief of rheumatology at the Birmingham VA Medical Center and associate professor of medicine in the division of rheumatology at the University of Alabama at Birmingham.
“Our patients with gout are interested in what they can do in their lives that might help with their gout. In the past, we’ve had generic advice about changing their diet. But in general, the evidence for the impact of dietary changes has not been strong.”
Doctors can now recommend a DASH-style diet, allowing room for moderate consumption of red meat, so long as patients are working on their weight loss – and showing results. “Now we have the information to give advice that’s more evidence-based,” Dr. Gaffo said. “You can ask the question whether this study is applicable to patients who already have gout. It doesn’t directly address them. But it mainly builds on the narrative that weight loss is important.”
Other studies have also looked at how weight loss led to serum urate reduction. This study adds to a growing body of literature emphasizing that the most important lifestyle factor relative to gout risk is weight gain, and the simplest, most effective intervention is counseling patients about weight loss, he said.
This research was supported by grants from the National Institutes of Health. Dr. Choi reported receiving research support from Ironwood and Horizon and consulting fees from Ironwood, Selecta, Horizon, Takeda, Kowa, and Vaxart. No other relevant financial disclosures were reported.
SOURCE: McCormick N et al. JAMA Netw Open. 2020;3(11):e2027421. doi: 10.1001/jamanetworkopen.2020.27421.
FROM JAMA NETWORK OPEN
Gender surgical outcomes differ following puberty suppression
Puberty suppression (PS) not only successfully reduces the physical development of sex characteristics, giving transgender youth the opportunity to qualify “for different gender-affirming surgical techniques, it also gives adolescents the time needed to explore their gender identity prior to beginning irreversible cross-sex hormone (CSH) treatment,” Tim C. van de Grift, MD, PhD, of the Vrije Universiteit Medical Center, Amsterdam, and colleagues reported in a retrospective single-center cohort study published in Pediatrics.
Dr. van de Grift and his colleagues evaluated the development of sex characteristics in 184 (61%) transgender men and 116 (39%) transgender women aged an average of 23 years at follow-up; a total of 50 men and 50 women served as controls within the total patient pool. The patients, identified from local registries, were adolescents at the time who had applied for gender-affirming medical interventions between 2006 and 2013.
In order to be included in the analysis, patients were required to 1) have a confirmed gender dysphoria diagnosis, 2) be at least 18 years of age at the point of data collection, 3) be less than 18 years of age when PS was initiated, 4) have initiated and continued PS treatment, and 5) not be lost to follow-up.
Clinical controls were identified by random sample using hospital records. Unlike patients in the PS cohort, the controls received CSH instead of PS, but they otherwise applied for gender-affirming surgery during the same years and met all other non-PS inclusion criteria.
PS offers more favorable, less invasive outcomes for transgender men than women
The researchers found no statistically significant impact of PS on height, weight, and body mass index preoperatively in either transgender men or women.
In transgender men, breast development differed the most, with the least development in the Tanner 2/3 puberty scale group, intermediate development in Tanner 4/5 patients, and the most development in controls who did not have PS. As a result, fewer mastectomies were required after PS, and those that were performed were less invasive, compared with controls. Dr. van de Grift and colleagues noted that these findings were in line with surgical guidelines that advise which mastectomy technique is appropriate based on breast size, elasticity, and ptosis grade. They cautioned that, while PS improves the odds of not needing a mastectomy, it is not a guaranteed outcome.
In transgender women, PS had a significant effect on penile development, which was less in Tanner 2/3 patients, compared with the other groups and less in Tanner 4/5 patients, compared with controls. As the researchers explained, penile length is key to vaginoplasty surgery since the penile skin is what is used to create the vaginal lining. For patients lacking sufficient skin, an alternative vaginoplasty technique using intestinal tissue or full-thickness graft is necessary. In this group, surgical options depended upon the onset of PS. In the control group, standard penile-inversion vaginoplasty was more probable, but it was less so in the Tanner 4/5 patients and only infrequently probable in Tanner 2/3 patients. Most transgender women who started PS in Tanner 2/3 underwent intestinal vaginoplasty.
Before PS is initiated much dialog and planning is warranted
“Clinicians should counsel transgender youth and their parents in making informed decisions when starting PS. Counseling consists of informing about the possible surgical consequences when puberty is suppressed and that these techniques may not be available in general transgender care facilities,” advised Dr. van de Grift and his colleagues. Specifically, when pediatricians prescribe PS, they need to be cognizant of the consequences down the line regarding the demand for “technically complex gender-affirming surgery,” performed by, for example, plastic surgeons, who will need to be “skilled in minimally invasive mastectomy techniques and more extensive vaginoplasty approaches.” Therefore, it is key for referring physicians to be sensitive to the need for early referral to specialized care in order to maximize positive outcomes, they added.
The study was limited by the sample size of some subgroups. Only two-thirds of eligible candidates were included in the sample size because follow-up data were not available for the remaining patients. Future studies should include multicenter standardized prospective data collection that provides patient-reported outcomes to enhance the perspective of the clinical findings, the researchers observed.
In a separate interview with Pediatric News, M. Brett Cooper, MD, of the department of pediatrics at University of Texas, Dallas, and an adolescent medicine physician at Children’s Medical Center in Dallas, noted that “Initiation of puberty suppression can be lifesaving for many gender-diverse youth, preventing the development of secondary sex characteristics. However, this can have effects later if these youth choose to pursue gender-affirming surgeries. This study is important for helping to frame the conversation for youth and their parents when doing consent to start puberty-blocking medications, as well as around optimal timing for each individual.”
Dr. Cooper is a paid MDedge consultant for the LGBTQ Youth Consult in Pediatric News. He had no other disclosures to report.
SOURCE: van de Grift T et al. Pediatrics. 2020;146(5):e20193653.
Puberty suppression (PS) not only successfully reduces the physical development of sex characteristics, giving transgender youth the opportunity to qualify “for different gender-affirming surgical techniques, it also gives adolescents the time needed to explore their gender identity prior to beginning irreversible cross-sex hormone (CSH) treatment,” Tim C. van de Grift, MD, PhD, of the Vrije Universiteit Medical Center, Amsterdam, and colleagues reported in a retrospective single-center cohort study published in Pediatrics.
Dr. van de Grift and his colleagues evaluated the development of sex characteristics in 184 (61%) transgender men and 116 (39%) transgender women aged an average of 23 years at follow-up; a total of 50 men and 50 women served as controls within the total patient pool. The patients, identified from local registries, were adolescents at the time who had applied for gender-affirming medical interventions between 2006 and 2013.
In order to be included in the analysis, patients were required to 1) have a confirmed gender dysphoria diagnosis, 2) be at least 18 years of age at the point of data collection, 3) be less than 18 years of age when PS was initiated, 4) have initiated and continued PS treatment, and 5) not be lost to follow-up.
Clinical controls were identified by random sample using hospital records. Unlike patients in the PS cohort, the controls received CSH instead of PS, but they otherwise applied for gender-affirming surgery during the same years and met all other non-PS inclusion criteria.
PS offers more favorable, less invasive outcomes for transgender men than women
The researchers found no statistically significant impact of PS on height, weight, and body mass index preoperatively in either transgender men or women.
In transgender men, breast development differed the most, with the least development in the Tanner 2/3 puberty scale group, intermediate development in Tanner 4/5 patients, and the most development in controls who did not have PS. As a result, fewer mastectomies were required after PS, and those that were performed were less invasive, compared with controls. Dr. van de Grift and colleagues noted that these findings were in line with surgical guidelines that advise which mastectomy technique is appropriate based on breast size, elasticity, and ptosis grade. They cautioned that, while PS improves the odds of not needing a mastectomy, it is not a guaranteed outcome.
In transgender women, PS had a significant effect on penile development, which was less in Tanner 2/3 patients, compared with the other groups and less in Tanner 4/5 patients, compared with controls. As the researchers explained, penile length is key to vaginoplasty surgery since the penile skin is what is used to create the vaginal lining. For patients lacking sufficient skin, an alternative vaginoplasty technique using intestinal tissue or full-thickness graft is necessary. In this group, surgical options depended upon the onset of PS. In the control group, standard penile-inversion vaginoplasty was more probable, but it was less so in the Tanner 4/5 patients and only infrequently probable in Tanner 2/3 patients. Most transgender women who started PS in Tanner 2/3 underwent intestinal vaginoplasty.
Before PS is initiated much dialog and planning is warranted
“Clinicians should counsel transgender youth and their parents in making informed decisions when starting PS. Counseling consists of informing about the possible surgical consequences when puberty is suppressed and that these techniques may not be available in general transgender care facilities,” advised Dr. van de Grift and his colleagues. Specifically, when pediatricians prescribe PS, they need to be cognizant of the consequences down the line regarding the demand for “technically complex gender-affirming surgery,” performed by, for example, plastic surgeons, who will need to be “skilled in minimally invasive mastectomy techniques and more extensive vaginoplasty approaches.” Therefore, it is key for referring physicians to be sensitive to the need for early referral to specialized care in order to maximize positive outcomes, they added.
The study was limited by the sample size of some subgroups. Only two-thirds of eligible candidates were included in the sample size because follow-up data were not available for the remaining patients. Future studies should include multicenter standardized prospective data collection that provides patient-reported outcomes to enhance the perspective of the clinical findings, the researchers observed.
In a separate interview with Pediatric News, M. Brett Cooper, MD, of the department of pediatrics at University of Texas, Dallas, and an adolescent medicine physician at Children’s Medical Center in Dallas, noted that “Initiation of puberty suppression can be lifesaving for many gender-diverse youth, preventing the development of secondary sex characteristics. However, this can have effects later if these youth choose to pursue gender-affirming surgeries. This study is important for helping to frame the conversation for youth and their parents when doing consent to start puberty-blocking medications, as well as around optimal timing for each individual.”
Dr. Cooper is a paid MDedge consultant for the LGBTQ Youth Consult in Pediatric News. He had no other disclosures to report.
SOURCE: van de Grift T et al. Pediatrics. 2020;146(5):e20193653.
Puberty suppression (PS) not only successfully reduces the physical development of sex characteristics, giving transgender youth the opportunity to qualify “for different gender-affirming surgical techniques, it also gives adolescents the time needed to explore their gender identity prior to beginning irreversible cross-sex hormone (CSH) treatment,” Tim C. van de Grift, MD, PhD, of the Vrije Universiteit Medical Center, Amsterdam, and colleagues reported in a retrospective single-center cohort study published in Pediatrics.
Dr. van de Grift and his colleagues evaluated the development of sex characteristics in 184 (61%) transgender men and 116 (39%) transgender women aged an average of 23 years at follow-up; a total of 50 men and 50 women served as controls within the total patient pool. The patients, identified from local registries, were adolescents at the time who had applied for gender-affirming medical interventions between 2006 and 2013.
In order to be included in the analysis, patients were required to 1) have a confirmed gender dysphoria diagnosis, 2) be at least 18 years of age at the point of data collection, 3) be less than 18 years of age when PS was initiated, 4) have initiated and continued PS treatment, and 5) not be lost to follow-up.
Clinical controls were identified by random sample using hospital records. Unlike patients in the PS cohort, the controls received CSH instead of PS, but they otherwise applied for gender-affirming surgery during the same years and met all other non-PS inclusion criteria.
PS offers more favorable, less invasive outcomes for transgender men than women
The researchers found no statistically significant impact of PS on height, weight, and body mass index preoperatively in either transgender men or women.
In transgender men, breast development differed the most, with the least development in the Tanner 2/3 puberty scale group, intermediate development in Tanner 4/5 patients, and the most development in controls who did not have PS. As a result, fewer mastectomies were required after PS, and those that were performed were less invasive, compared with controls. Dr. van de Grift and colleagues noted that these findings were in line with surgical guidelines that advise which mastectomy technique is appropriate based on breast size, elasticity, and ptosis grade. They cautioned that, while PS improves the odds of not needing a mastectomy, it is not a guaranteed outcome.
In transgender women, PS had a significant effect on penile development, which was less in Tanner 2/3 patients, compared with the other groups and less in Tanner 4/5 patients, compared with controls. As the researchers explained, penile length is key to vaginoplasty surgery since the penile skin is what is used to create the vaginal lining. For patients lacking sufficient skin, an alternative vaginoplasty technique using intestinal tissue or full-thickness graft is necessary. In this group, surgical options depended upon the onset of PS. In the control group, standard penile-inversion vaginoplasty was more probable, but it was less so in the Tanner 4/5 patients and only infrequently probable in Tanner 2/3 patients. Most transgender women who started PS in Tanner 2/3 underwent intestinal vaginoplasty.
Before PS is initiated much dialog and planning is warranted
“Clinicians should counsel transgender youth and their parents in making informed decisions when starting PS. Counseling consists of informing about the possible surgical consequences when puberty is suppressed and that these techniques may not be available in general transgender care facilities,” advised Dr. van de Grift and his colleagues. Specifically, when pediatricians prescribe PS, they need to be cognizant of the consequences down the line regarding the demand for “technically complex gender-affirming surgery,” performed by, for example, plastic surgeons, who will need to be “skilled in minimally invasive mastectomy techniques and more extensive vaginoplasty approaches.” Therefore, it is key for referring physicians to be sensitive to the need for early referral to specialized care in order to maximize positive outcomes, they added.
The study was limited by the sample size of some subgroups. Only two-thirds of eligible candidates were included in the sample size because follow-up data were not available for the remaining patients. Future studies should include multicenter standardized prospective data collection that provides patient-reported outcomes to enhance the perspective of the clinical findings, the researchers observed.
In a separate interview with Pediatric News, M. Brett Cooper, MD, of the department of pediatrics at University of Texas, Dallas, and an adolescent medicine physician at Children’s Medical Center in Dallas, noted that “Initiation of puberty suppression can be lifesaving for many gender-diverse youth, preventing the development of secondary sex characteristics. However, this can have effects later if these youth choose to pursue gender-affirming surgeries. This study is important for helping to frame the conversation for youth and their parents when doing consent to start puberty-blocking medications, as well as around optimal timing for each individual.”
Dr. Cooper is a paid MDedge consultant for the LGBTQ Youth Consult in Pediatric News. He had no other disclosures to report.
SOURCE: van de Grift T et al. Pediatrics. 2020;146(5):e20193653.
FROM PEDIATRICS
Choosing civility
I am reading an excellent book called “Choosing Civility,” by P. M. Forni, cofounder of the John Hopkins Civility Project. It is a quick read and is a book that, in particular, all politicians, reporters, and political pundits should read. Most of it deals with common-sense good manners – things your mother taught you. The chapter that has been the most difficult for me to read (and to apply in practice) was the one on listening. I must admit I have been, or am guilty of being, a poor listener. I often try to expedite things by jumping ahead of where the speaker is going, my logic being that I am saving everyone time. In reality, I am probably distorting what the speaker intends to say and certainly not endearing myself to the speaker.
This is, of course, a classic example of attention deficit disorder with which I am certain I am afflicted. I have to make a deliberate effort to pause in my responses to speakers so that they can finish what they have to say. This is extremely hard for those of us who have this problem. I have made progress over the years and can attend committee meetings and say very little, except an occasional clarification query. I make a deliberate attempt to be civil and respect other’s comments. I have learned to let meetings reach their natural conclusion, which takes great patience when we could have arrived there hours earlier if I had interrupted and been less civil. If that course is taken, you will not have the buy in from all participants, and any decision made might not stick.
Luckily, almost all our discussions in organized medicine are civil, and our behavior has improved. The attending surgeon throwing instruments at the nurse or hitting the resident with a retractor – incidents that I have personally witnessed – would not be tolerated today. Our medical meetings are usually civil, if not downright boring.
Of course, patients who are ill or anxious are exempt from any civility requirement. They need comfort and reassurance, as much as a discussion of their diagnosis and treatment plan. They are allowed to be uncivil in their questions and responses.
A few years ago, when I was training a fellow who was Black, I was horrified when one of my patients treated him with disdain and a gross racist attitude. This patient was uncivil, which of course had nothing to do with his diagnosis or treatment. I excused the fellow, discussed this with the patient, and tried to explain that the doctor’s skin color had nothing to do with his training or competence. I went further and told him that if this continued, he would be excused from my practice, which he eventually was. I apologized to the fellow, who, after living in his skin his whole life, had already shaken it off, having heard it all before. Living in my bubble I had thought this type of uncivil behavior was long gone, but not so.
This topic has received discussion and policy action at the American Medical Association. The AMA has adopted a new policy that “recognizes racism as a public health threat and commits to actively work on dismantling racist policies and practices across all of health care,” according to an AMA press release. This includes a recommendation to “clearly and openly support physicians, trainees, and facility personnel who experience prejudiced behavior and discrimination by patients, including allowing physicians, trainees, and facility personnel to decline to care for those patients, without penalty, who have exhibited discriminatory behavior specifically toward them,” according to the AMA report.
As far as I go, not to worry; I still have personal issues to work on. My wife’s favorite song is by Alison Krauss when she sings, “you say it best when you say nothing at all.”
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.
I am reading an excellent book called “Choosing Civility,” by P. M. Forni, cofounder of the John Hopkins Civility Project. It is a quick read and is a book that, in particular, all politicians, reporters, and political pundits should read. Most of it deals with common-sense good manners – things your mother taught you. The chapter that has been the most difficult for me to read (and to apply in practice) was the one on listening. I must admit I have been, or am guilty of being, a poor listener. I often try to expedite things by jumping ahead of where the speaker is going, my logic being that I am saving everyone time. In reality, I am probably distorting what the speaker intends to say and certainly not endearing myself to the speaker.
This is, of course, a classic example of attention deficit disorder with which I am certain I am afflicted. I have to make a deliberate effort to pause in my responses to speakers so that they can finish what they have to say. This is extremely hard for those of us who have this problem. I have made progress over the years and can attend committee meetings and say very little, except an occasional clarification query. I make a deliberate attempt to be civil and respect other’s comments. I have learned to let meetings reach their natural conclusion, which takes great patience when we could have arrived there hours earlier if I had interrupted and been less civil. If that course is taken, you will not have the buy in from all participants, and any decision made might not stick.
Luckily, almost all our discussions in organized medicine are civil, and our behavior has improved. The attending surgeon throwing instruments at the nurse or hitting the resident with a retractor – incidents that I have personally witnessed – would not be tolerated today. Our medical meetings are usually civil, if not downright boring.
Of course, patients who are ill or anxious are exempt from any civility requirement. They need comfort and reassurance, as much as a discussion of their diagnosis and treatment plan. They are allowed to be uncivil in their questions and responses.
A few years ago, when I was training a fellow who was Black, I was horrified when one of my patients treated him with disdain and a gross racist attitude. This patient was uncivil, which of course had nothing to do with his diagnosis or treatment. I excused the fellow, discussed this with the patient, and tried to explain that the doctor’s skin color had nothing to do with his training or competence. I went further and told him that if this continued, he would be excused from my practice, which he eventually was. I apologized to the fellow, who, after living in his skin his whole life, had already shaken it off, having heard it all before. Living in my bubble I had thought this type of uncivil behavior was long gone, but not so.
This topic has received discussion and policy action at the American Medical Association. The AMA has adopted a new policy that “recognizes racism as a public health threat and commits to actively work on dismantling racist policies and practices across all of health care,” according to an AMA press release. This includes a recommendation to “clearly and openly support physicians, trainees, and facility personnel who experience prejudiced behavior and discrimination by patients, including allowing physicians, trainees, and facility personnel to decline to care for those patients, without penalty, who have exhibited discriminatory behavior specifically toward them,” according to the AMA report.
As far as I go, not to worry; I still have personal issues to work on. My wife’s favorite song is by Alison Krauss when she sings, “you say it best when you say nothing at all.”
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.
I am reading an excellent book called “Choosing Civility,” by P. M. Forni, cofounder of the John Hopkins Civility Project. It is a quick read and is a book that, in particular, all politicians, reporters, and political pundits should read. Most of it deals with common-sense good manners – things your mother taught you. The chapter that has been the most difficult for me to read (and to apply in practice) was the one on listening. I must admit I have been, or am guilty of being, a poor listener. I often try to expedite things by jumping ahead of where the speaker is going, my logic being that I am saving everyone time. In reality, I am probably distorting what the speaker intends to say and certainly not endearing myself to the speaker.
This is, of course, a classic example of attention deficit disorder with which I am certain I am afflicted. I have to make a deliberate effort to pause in my responses to speakers so that they can finish what they have to say. This is extremely hard for those of us who have this problem. I have made progress over the years and can attend committee meetings and say very little, except an occasional clarification query. I make a deliberate attempt to be civil and respect other’s comments. I have learned to let meetings reach their natural conclusion, which takes great patience when we could have arrived there hours earlier if I had interrupted and been less civil. If that course is taken, you will not have the buy in from all participants, and any decision made might not stick.
Luckily, almost all our discussions in organized medicine are civil, and our behavior has improved. The attending surgeon throwing instruments at the nurse or hitting the resident with a retractor – incidents that I have personally witnessed – would not be tolerated today. Our medical meetings are usually civil, if not downright boring.
Of course, patients who are ill or anxious are exempt from any civility requirement. They need comfort and reassurance, as much as a discussion of their diagnosis and treatment plan. They are allowed to be uncivil in their questions and responses.
A few years ago, when I was training a fellow who was Black, I was horrified when one of my patients treated him with disdain and a gross racist attitude. This patient was uncivil, which of course had nothing to do with his diagnosis or treatment. I excused the fellow, discussed this with the patient, and tried to explain that the doctor’s skin color had nothing to do with his training or competence. I went further and told him that if this continued, he would be excused from my practice, which he eventually was. I apologized to the fellow, who, after living in his skin his whole life, had already shaken it off, having heard it all before. Living in my bubble I had thought this type of uncivil behavior was long gone, but not so.
This topic has received discussion and policy action at the American Medical Association. The AMA has adopted a new policy that “recognizes racism as a public health threat and commits to actively work on dismantling racist policies and practices across all of health care,” according to an AMA press release. This includes a recommendation to “clearly and openly support physicians, trainees, and facility personnel who experience prejudiced behavior and discrimination by patients, including allowing physicians, trainees, and facility personnel to decline to care for those patients, without penalty, who have exhibited discriminatory behavior specifically toward them,” according to the AMA report.
As far as I go, not to worry; I still have personal issues to work on. My wife’s favorite song is by Alison Krauss when she sings, “you say it best when you say nothing at all.”
Dr. Coldiron is in private practice but maintains a clinical assistant professorship at the University of Cincinnati. He cares for patients, teaches medical students and residents, and has several active clinical research projects. Dr. Coldiron is the author of more than 80 scientific letters, papers, and several book chapters, and he speaks frequently on a variety of topics. He is a past president of the American Academy of Dermatology. Write to him at dermnews@mdedge.com.
FDA OKs osimertinib as first adjuvant drug for NSCLC
Osimertinib was first approved in the US in 2018 for the first-line treatment of patients with metastatic EGFR-mutated NSCLC.
With this new indication, “patients may be treated with this targeted therapy in an earlier and potentially more curative stage of non-small cell lung cancer,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a news release.
The expanded indication is based on results of the ADAURA clinical trial, which compared osimertinib with placebo following complete resection of localized or locally advanced NSCLC with negative margins.
In the trial, adjuvant osimertinib reduced the relative risk of disease recurrence or death by 83% in patients with stage II and IIIA disease (hazard ratio [HR], 0.17; 95% CI, 0.12 - 0.23; P < .0001).
Disease-free survival (DFS) in the overall trial population of patients with stage IB-IIIA disease showed osimertinib reduced the risk of disease recurrence or death by 80% (HR, 0.20; 95% CI, 0.15 - 0.27; P < .0001).
At 2 years, 89% of patients treated with the targeted agent remained alive and disease free vs 52% on placebo after surgery. The safety and tolerability of osimertinib in the adjuvant setting was consistent with previous trials in the metastatic setting.
The trial of 682 patients was unblinded early and halted on the recommendation of the independent data-monitoring committee, because of the efficacy of osimertinib.
“If I were on the committee, I would have done the same thing. These are extraordinary results,” study investigator Roy S. Herbst, MD, PhD, chief of medical oncology at the Yale Cancer Center, New Haven, Connecticut, said at a press briefing prior to the study presentation at the American Society of Clinical Oncology’s (ASCO) virtual scientific program last spring.
In a Medscape commentary, Mark Kris, MD, of Memorial Sloan Kettering Cancer Center in New York City, said the data with osimertinib in the adjuvant setting are “important and practice-changing.”
“The potential for this drug to improve outcomes has been there for a long time. This phase 3 randomized trial presented at the plenary session of ASCO showed a more than doubling of disease-free survival at 2 years. It shows that we can use therapies in the earlier stages of disease,” Kris noted.
“This approval dispels the notion that treatment is over after surgery and chemotherapy, as the ADAURA results show that Tagrisso can dramatically change the course of this disease,” Dave Fredrickson, executive vice president, AstraZeneca oncology business unit, said in a news release.
Osimertinib had orphan drug status and breakthrough therapy designation for treatment of EGFR mutation-positive NSCLC.
A version of this article first appeared on Medscape.com.
Osimertinib was first approved in the US in 2018 for the first-line treatment of patients with metastatic EGFR-mutated NSCLC.
With this new indication, “patients may be treated with this targeted therapy in an earlier and potentially more curative stage of non-small cell lung cancer,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a news release.
The expanded indication is based on results of the ADAURA clinical trial, which compared osimertinib with placebo following complete resection of localized or locally advanced NSCLC with negative margins.
In the trial, adjuvant osimertinib reduced the relative risk of disease recurrence or death by 83% in patients with stage II and IIIA disease (hazard ratio [HR], 0.17; 95% CI, 0.12 - 0.23; P < .0001).
Disease-free survival (DFS) in the overall trial population of patients with stage IB-IIIA disease showed osimertinib reduced the risk of disease recurrence or death by 80% (HR, 0.20; 95% CI, 0.15 - 0.27; P < .0001).
At 2 years, 89% of patients treated with the targeted agent remained alive and disease free vs 52% on placebo after surgery. The safety and tolerability of osimertinib in the adjuvant setting was consistent with previous trials in the metastatic setting.
The trial of 682 patients was unblinded early and halted on the recommendation of the independent data-monitoring committee, because of the efficacy of osimertinib.
“If I were on the committee, I would have done the same thing. These are extraordinary results,” study investigator Roy S. Herbst, MD, PhD, chief of medical oncology at the Yale Cancer Center, New Haven, Connecticut, said at a press briefing prior to the study presentation at the American Society of Clinical Oncology’s (ASCO) virtual scientific program last spring.
In a Medscape commentary, Mark Kris, MD, of Memorial Sloan Kettering Cancer Center in New York City, said the data with osimertinib in the adjuvant setting are “important and practice-changing.”
“The potential for this drug to improve outcomes has been there for a long time. This phase 3 randomized trial presented at the plenary session of ASCO showed a more than doubling of disease-free survival at 2 years. It shows that we can use therapies in the earlier stages of disease,” Kris noted.
“This approval dispels the notion that treatment is over after surgery and chemotherapy, as the ADAURA results show that Tagrisso can dramatically change the course of this disease,” Dave Fredrickson, executive vice president, AstraZeneca oncology business unit, said in a news release.
Osimertinib had orphan drug status and breakthrough therapy designation for treatment of EGFR mutation-positive NSCLC.
A version of this article first appeared on Medscape.com.
Osimertinib was first approved in the US in 2018 for the first-line treatment of patients with metastatic EGFR-mutated NSCLC.
With this new indication, “patients may be treated with this targeted therapy in an earlier and potentially more curative stage of non-small cell lung cancer,” Richard Pazdur, MD, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research, said in a news release.
The expanded indication is based on results of the ADAURA clinical trial, which compared osimertinib with placebo following complete resection of localized or locally advanced NSCLC with negative margins.
In the trial, adjuvant osimertinib reduced the relative risk of disease recurrence or death by 83% in patients with stage II and IIIA disease (hazard ratio [HR], 0.17; 95% CI, 0.12 - 0.23; P < .0001).
Disease-free survival (DFS) in the overall trial population of patients with stage IB-IIIA disease showed osimertinib reduced the risk of disease recurrence or death by 80% (HR, 0.20; 95% CI, 0.15 - 0.27; P < .0001).
At 2 years, 89% of patients treated with the targeted agent remained alive and disease free vs 52% on placebo after surgery. The safety and tolerability of osimertinib in the adjuvant setting was consistent with previous trials in the metastatic setting.
The trial of 682 patients was unblinded early and halted on the recommendation of the independent data-monitoring committee, because of the efficacy of osimertinib.
“If I were on the committee, I would have done the same thing. These are extraordinary results,” study investigator Roy S. Herbst, MD, PhD, chief of medical oncology at the Yale Cancer Center, New Haven, Connecticut, said at a press briefing prior to the study presentation at the American Society of Clinical Oncology’s (ASCO) virtual scientific program last spring.
In a Medscape commentary, Mark Kris, MD, of Memorial Sloan Kettering Cancer Center in New York City, said the data with osimertinib in the adjuvant setting are “important and practice-changing.”
“The potential for this drug to improve outcomes has been there for a long time. This phase 3 randomized trial presented at the plenary session of ASCO showed a more than doubling of disease-free survival at 2 years. It shows that we can use therapies in the earlier stages of disease,” Kris noted.
“This approval dispels the notion that treatment is over after surgery and chemotherapy, as the ADAURA results show that Tagrisso can dramatically change the course of this disease,” Dave Fredrickson, executive vice president, AstraZeneca oncology business unit, said in a news release.
Osimertinib had orphan drug status and breakthrough therapy designation for treatment of EGFR mutation-positive NSCLC.
A version of this article first appeared on Medscape.com.
No benefit of cannabis on depression in pregnant women with OUD
Cannabis is ineffective at alleviating depression in pregnant women undergoing opioid agonist therapy (OAT), new research shows.
A study of more than 120 pregnant women undergoing treatment of opioid use disorder (OUD) showed that those who used cannabis to alleviate their depressive symptoms while undergoing OAT continued to have high depression scores at the end of opioid treatment.
In addition, depression scores improved for those who abstained from cannabis use after their first positive screen. Interestingly, cannabis use did not affect patient retention in treatment for OUD, the investigators note.
“To our knowledge, this is the first time looking at the impact of cannabis on the specific population of pregnant women with opioid use disorder, who are very vulnerable to depression,” lead author Abigail Richison, MD, University of Arkansas for Medical Sciences, Little Rock, said in an interview.
The findings were presented at the American Academy of Addiction Psychiatry (AAAP) 31st Annual Meeting, which was held online this year because of the COVID-19 pandemic.
A safer alternative?
Data from the National Survey on Drug Use and Health show that perinatal cannabis use increased by 62% between 2002 and 2014. Many women try to ameliorate their depression symptoms by using cannabis in the mistaken belief that it will help their depression, the investigators noted.
In addition, many women consider cannabis safer during pregnancy than prescribed medications for improving mood, said Dr. Richison. She said that cannabis does not alleviate depression and may even worsen it.
Dr. Richison noted that at her center, which has a women’s health program that treats pregnant women with OUDs, she was seeing a lot of patients who reported using cannabis to improve their mood.
“However, it didn’t seem like it was really helping, so I started researching about cannabis and depression,” Dr. Richison said.
“ and can be accused of perinatal substance use. I think it is very important to screen for depression as well as cannabis use in this population,” she added.
To shed some light on the impact of cannabis use by pregnant patients with OUD, the investigators conducted a retrospective chart review of 121 pregnant women with OUD who attended outpatient OAT. All were prescribed buprenorphine.
At each visit, Beck Depression Inventory (BDI) scores were obtained and urine drug screens were administered. The primary outcome was BDI score. Other measures included retention, urinary drug screen results, and antidepressant use.
The women were divided into two groups. The first comprised cannabis users, defined as having more than one urine drug screen that was positive for cannabis (n = 35). The other group comprised nonusers, defined as having urine drug screens that were negative for cannabis (n = 86).
Cannabis users were a little younger (mean age, 27 years) than non–cannabis users (mean age, 29.5 years; P = .006). Most of the participants were White (80.2%). Roughly half were on Medicaid, and most of the other participants had private insurance; a small number of women had no insurance.
Results showed that cannabis users had significantly higher BDI scores than non–cannabis users (mean scores, 16 vs. 9.3; P < .001).
Cannabis use continued to be associated with elevated scores for depression when controlling for opioid misuse and antidepressant use. There were no significant differences in retention or lapse to opioid misuse between the two groups.
More evidence of risk
Commenting on the findings in an interview, Carla Marienfeld, MD, professor of psychiatry at the University of California, San Diego, said there is a growing body of evidence about risks from cannabis use during pregnancy, “a time where we already know the endocannabinoid system is very active in the developing fetus.”
She noted that the current study’s design makes it hard to know whether marijuana use causes worse depression.
However, “it clearly is not associated with helping to improve mood the way people who are using it believe or hope for,” said Dr. Marienfeld, who was not part of the research.
“The risk for harm in terms of worse mood for the pregnant woman or risks for harm to the developing fetus are being better understood with many new studies,” she added.
Yet as more and more states legalize medical marijuana, cannabis use during pregnancy is only going to rise, experts fear.
Cornel Stanciu, MD, of Dartmouth-Hitchcock Medical Center, Lebanon, N.H., who was asked for comment, noted that public endorsement for potential benefits of the marijuana plant is at an all-time high.
“To date, 33 states and the District of Columbia have responded by legalizing medical marijuana, with 10 states also having legalized recreational use of marijuana. The current practice is said to be ahead of science, as robust research has been hindered by strict regulations – and most epidemiological studies point toward harmful associations,” Dr. Stanciu said in an interview.
“Given the decreased perception of harm by the general public, women are certainly compelled to seek what they perceive as more natural self-management remedies,” he said.
A harmful habit
Dr. Stanciu cited a recent study conducted in Colorado in which researchers contacted cannabis dispensaries, identified themselves as being pregnant, and asked for guidance in managing pregnancy-related symptoms.
Almost 70% of dispensaries recommended products to treat symptoms, particularly in the vulnerable first trimester; 36% of them also provided reassurance of the safety profile. Very few encouraged a discussion with the physician.
“Consumption of cannabis during pregnancy results in cannabinoid placental crossing and accumulation in the fetal brain, as well as other organs, where it interferes with neurodevelopment and the endocannabinoid system,” he said.
In addition, retrospective studies have shown an association between prenatal cannabis ingestion and anemia in the mothers, low birth weight, greater risk for preterm and stillbirths, and increased need for neonatal ICU admissions.
“Children born to mothers who used cannabis during pregnancy have higher rates of impulsivity, delinquency, learning and memory impairment, as well as executive function deficits. There is also an increased association with proneness to psychosis during middle childhood,” Dr. Stanciu said.
When used during pregnancy, cannabis has been associated with increased anxiety in mothers, as well as increased risk for depressive disorders, incidence of suicidal ideations and behavior, and symptoms of mania and psychosis among those with bipolar and schizophrenia spectrum conditions. Cannabis has also been linked to coingestion of other substances and with alcohol use.
“So cannabis can pose harm, especially when used by those with affective disorders,” Dr. Stanciu said.
The study was funded by the National Institute on Drug Abuse. Dr. Richison, Dr. Marienfeld, and Dr. Stanciu have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com
Cannabis is ineffective at alleviating depression in pregnant women undergoing opioid agonist therapy (OAT), new research shows.
A study of more than 120 pregnant women undergoing treatment of opioid use disorder (OUD) showed that those who used cannabis to alleviate their depressive symptoms while undergoing OAT continued to have high depression scores at the end of opioid treatment.
In addition, depression scores improved for those who abstained from cannabis use after their first positive screen. Interestingly, cannabis use did not affect patient retention in treatment for OUD, the investigators note.
“To our knowledge, this is the first time looking at the impact of cannabis on the specific population of pregnant women with opioid use disorder, who are very vulnerable to depression,” lead author Abigail Richison, MD, University of Arkansas for Medical Sciences, Little Rock, said in an interview.
The findings were presented at the American Academy of Addiction Psychiatry (AAAP) 31st Annual Meeting, which was held online this year because of the COVID-19 pandemic.
A safer alternative?
Data from the National Survey on Drug Use and Health show that perinatal cannabis use increased by 62% between 2002 and 2014. Many women try to ameliorate their depression symptoms by using cannabis in the mistaken belief that it will help their depression, the investigators noted.
In addition, many women consider cannabis safer during pregnancy than prescribed medications for improving mood, said Dr. Richison. She said that cannabis does not alleviate depression and may even worsen it.
Dr. Richison noted that at her center, which has a women’s health program that treats pregnant women with OUDs, she was seeing a lot of patients who reported using cannabis to improve their mood.
“However, it didn’t seem like it was really helping, so I started researching about cannabis and depression,” Dr. Richison said.
“ and can be accused of perinatal substance use. I think it is very important to screen for depression as well as cannabis use in this population,” she added.
To shed some light on the impact of cannabis use by pregnant patients with OUD, the investigators conducted a retrospective chart review of 121 pregnant women with OUD who attended outpatient OAT. All were prescribed buprenorphine.
At each visit, Beck Depression Inventory (BDI) scores were obtained and urine drug screens were administered. The primary outcome was BDI score. Other measures included retention, urinary drug screen results, and antidepressant use.
The women were divided into two groups. The first comprised cannabis users, defined as having more than one urine drug screen that was positive for cannabis (n = 35). The other group comprised nonusers, defined as having urine drug screens that were negative for cannabis (n = 86).
Cannabis users were a little younger (mean age, 27 years) than non–cannabis users (mean age, 29.5 years; P = .006). Most of the participants were White (80.2%). Roughly half were on Medicaid, and most of the other participants had private insurance; a small number of women had no insurance.
Results showed that cannabis users had significantly higher BDI scores than non–cannabis users (mean scores, 16 vs. 9.3; P < .001).
Cannabis use continued to be associated with elevated scores for depression when controlling for opioid misuse and antidepressant use. There were no significant differences in retention or lapse to opioid misuse between the two groups.
More evidence of risk
Commenting on the findings in an interview, Carla Marienfeld, MD, professor of psychiatry at the University of California, San Diego, said there is a growing body of evidence about risks from cannabis use during pregnancy, “a time where we already know the endocannabinoid system is very active in the developing fetus.”
She noted that the current study’s design makes it hard to know whether marijuana use causes worse depression.
However, “it clearly is not associated with helping to improve mood the way people who are using it believe or hope for,” said Dr. Marienfeld, who was not part of the research.
“The risk for harm in terms of worse mood for the pregnant woman or risks for harm to the developing fetus are being better understood with many new studies,” she added.
Yet as more and more states legalize medical marijuana, cannabis use during pregnancy is only going to rise, experts fear.
Cornel Stanciu, MD, of Dartmouth-Hitchcock Medical Center, Lebanon, N.H., who was asked for comment, noted that public endorsement for potential benefits of the marijuana plant is at an all-time high.
“To date, 33 states and the District of Columbia have responded by legalizing medical marijuana, with 10 states also having legalized recreational use of marijuana. The current practice is said to be ahead of science, as robust research has been hindered by strict regulations – and most epidemiological studies point toward harmful associations,” Dr. Stanciu said in an interview.
“Given the decreased perception of harm by the general public, women are certainly compelled to seek what they perceive as more natural self-management remedies,” he said.
A harmful habit
Dr. Stanciu cited a recent study conducted in Colorado in which researchers contacted cannabis dispensaries, identified themselves as being pregnant, and asked for guidance in managing pregnancy-related symptoms.
Almost 70% of dispensaries recommended products to treat symptoms, particularly in the vulnerable first trimester; 36% of them also provided reassurance of the safety profile. Very few encouraged a discussion with the physician.
“Consumption of cannabis during pregnancy results in cannabinoid placental crossing and accumulation in the fetal brain, as well as other organs, where it interferes with neurodevelopment and the endocannabinoid system,” he said.
In addition, retrospective studies have shown an association between prenatal cannabis ingestion and anemia in the mothers, low birth weight, greater risk for preterm and stillbirths, and increased need for neonatal ICU admissions.
“Children born to mothers who used cannabis during pregnancy have higher rates of impulsivity, delinquency, learning and memory impairment, as well as executive function deficits. There is also an increased association with proneness to psychosis during middle childhood,” Dr. Stanciu said.
When used during pregnancy, cannabis has been associated with increased anxiety in mothers, as well as increased risk for depressive disorders, incidence of suicidal ideations and behavior, and symptoms of mania and psychosis among those with bipolar and schizophrenia spectrum conditions. Cannabis has also been linked to coingestion of other substances and with alcohol use.
“So cannabis can pose harm, especially when used by those with affective disorders,” Dr. Stanciu said.
The study was funded by the National Institute on Drug Abuse. Dr. Richison, Dr. Marienfeld, and Dr. Stanciu have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com
Cannabis is ineffective at alleviating depression in pregnant women undergoing opioid agonist therapy (OAT), new research shows.
A study of more than 120 pregnant women undergoing treatment of opioid use disorder (OUD) showed that those who used cannabis to alleviate their depressive symptoms while undergoing OAT continued to have high depression scores at the end of opioid treatment.
In addition, depression scores improved for those who abstained from cannabis use after their first positive screen. Interestingly, cannabis use did not affect patient retention in treatment for OUD, the investigators note.
“To our knowledge, this is the first time looking at the impact of cannabis on the specific population of pregnant women with opioid use disorder, who are very vulnerable to depression,” lead author Abigail Richison, MD, University of Arkansas for Medical Sciences, Little Rock, said in an interview.
The findings were presented at the American Academy of Addiction Psychiatry (AAAP) 31st Annual Meeting, which was held online this year because of the COVID-19 pandemic.
A safer alternative?
Data from the National Survey on Drug Use and Health show that perinatal cannabis use increased by 62% between 2002 and 2014. Many women try to ameliorate their depression symptoms by using cannabis in the mistaken belief that it will help their depression, the investigators noted.
In addition, many women consider cannabis safer during pregnancy than prescribed medications for improving mood, said Dr. Richison. She said that cannabis does not alleviate depression and may even worsen it.
Dr. Richison noted that at her center, which has a women’s health program that treats pregnant women with OUDs, she was seeing a lot of patients who reported using cannabis to improve their mood.
“However, it didn’t seem like it was really helping, so I started researching about cannabis and depression,” Dr. Richison said.
“ and can be accused of perinatal substance use. I think it is very important to screen for depression as well as cannabis use in this population,” she added.
To shed some light on the impact of cannabis use by pregnant patients with OUD, the investigators conducted a retrospective chart review of 121 pregnant women with OUD who attended outpatient OAT. All were prescribed buprenorphine.
At each visit, Beck Depression Inventory (BDI) scores were obtained and urine drug screens were administered. The primary outcome was BDI score. Other measures included retention, urinary drug screen results, and antidepressant use.
The women were divided into two groups. The first comprised cannabis users, defined as having more than one urine drug screen that was positive for cannabis (n = 35). The other group comprised nonusers, defined as having urine drug screens that were negative for cannabis (n = 86).
Cannabis users were a little younger (mean age, 27 years) than non–cannabis users (mean age, 29.5 years; P = .006). Most of the participants were White (80.2%). Roughly half were on Medicaid, and most of the other participants had private insurance; a small number of women had no insurance.
Results showed that cannabis users had significantly higher BDI scores than non–cannabis users (mean scores, 16 vs. 9.3; P < .001).
Cannabis use continued to be associated with elevated scores for depression when controlling for opioid misuse and antidepressant use. There were no significant differences in retention or lapse to opioid misuse between the two groups.
More evidence of risk
Commenting on the findings in an interview, Carla Marienfeld, MD, professor of psychiatry at the University of California, San Diego, said there is a growing body of evidence about risks from cannabis use during pregnancy, “a time where we already know the endocannabinoid system is very active in the developing fetus.”
She noted that the current study’s design makes it hard to know whether marijuana use causes worse depression.
However, “it clearly is not associated with helping to improve mood the way people who are using it believe or hope for,” said Dr. Marienfeld, who was not part of the research.
“The risk for harm in terms of worse mood for the pregnant woman or risks for harm to the developing fetus are being better understood with many new studies,” she added.
Yet as more and more states legalize medical marijuana, cannabis use during pregnancy is only going to rise, experts fear.
Cornel Stanciu, MD, of Dartmouth-Hitchcock Medical Center, Lebanon, N.H., who was asked for comment, noted that public endorsement for potential benefits of the marijuana plant is at an all-time high.
“To date, 33 states and the District of Columbia have responded by legalizing medical marijuana, with 10 states also having legalized recreational use of marijuana. The current practice is said to be ahead of science, as robust research has been hindered by strict regulations – and most epidemiological studies point toward harmful associations,” Dr. Stanciu said in an interview.
“Given the decreased perception of harm by the general public, women are certainly compelled to seek what they perceive as more natural self-management remedies,” he said.
A harmful habit
Dr. Stanciu cited a recent study conducted in Colorado in which researchers contacted cannabis dispensaries, identified themselves as being pregnant, and asked for guidance in managing pregnancy-related symptoms.
Almost 70% of dispensaries recommended products to treat symptoms, particularly in the vulnerable first trimester; 36% of them also provided reassurance of the safety profile. Very few encouraged a discussion with the physician.
“Consumption of cannabis during pregnancy results in cannabinoid placental crossing and accumulation in the fetal brain, as well as other organs, where it interferes with neurodevelopment and the endocannabinoid system,” he said.
In addition, retrospective studies have shown an association between prenatal cannabis ingestion and anemia in the mothers, low birth weight, greater risk for preterm and stillbirths, and increased need for neonatal ICU admissions.
“Children born to mothers who used cannabis during pregnancy have higher rates of impulsivity, delinquency, learning and memory impairment, as well as executive function deficits. There is also an increased association with proneness to psychosis during middle childhood,” Dr. Stanciu said.
When used during pregnancy, cannabis has been associated with increased anxiety in mothers, as well as increased risk for depressive disorders, incidence of suicidal ideations and behavior, and symptoms of mania and psychosis among those with bipolar and schizophrenia spectrum conditions. Cannabis has also been linked to coingestion of other substances and with alcohol use.
“So cannabis can pose harm, especially when used by those with affective disorders,” Dr. Stanciu said.
The study was funded by the National Institute on Drug Abuse. Dr. Richison, Dr. Marienfeld, and Dr. Stanciu have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com