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News and Views that Matter to Pediatricians
The leading independent newspaper covering news and commentary in pediatrics.
One fish, two fish, are good fish for you ... fish
Good news for pregnant women; bad news for fish
As soon as women find out they’re pregnant, doctors recommend they give up smoking, drinking, and eating certain types of fish. That last item may need to be reconsidered, since a recent study supports the idea that it doesn’t matter what type of fish pregnant women are eating, as long as they’re eating it.
Researchers collected data from two different studies that reviewed the mercury levels of mothers from Bristol, England, and the Seychelles, a island chain off East Africa where “fish consumption is high and prenatal mercury levels are 10 times higher than in the [United States],” they said in NeuroToxicology.
Those data showed that the mercury levels had no adverse effects on child development as long as the mother ate fish. The nutrients and vitamins in the fish – vitamin D, long-chain fatty acids, selenium, and iodine – provide protection against mercury. There’s also the already-known benefits to eyesight and intellectual abilities that have been associated with fish consumption.
This analysis goes starkly against the grain of what is commonly recommended to expectant mothers, which is to cut out fish altogether. The researchers suggested that governments should review and change those recommendations to focus on the benefits instead.
As long as women follow the researchers’ recommendation to eat “at least two portions of fish a week, one of which should be oily,” they may not have to lay off on the sushi after all.
We’ll show our gut worms the world
Never let it be said that mankind is not a generous species. Sure, we could maybe be kinder to our fellow human beings, maybe declare a little less war on each other, but for the past 50,000 years, we’ve been giving a free ride to millions upon millions to one of mankind’s closest companions: the whipworm.
This revelation into human kindness comes from Denmark, where researchers from Copenhagen conducted a genetic analysis of ancient preserved whipworm eggs found in old Viking and Norse settlements, some of which date back over 2,000 years. In normal conditions genetic material wouldn’t last very long, but these were Viking whipworms eggs with tiny little horned helmets, so the DNA within has remained unchanged. Or it may be the tough chitinous exterior of the eggs protecting the DNA from degrading, combined with their preservation in moist soil.
Once they had their Viking whipworm DNA, the researchers compared it with whipworm DNA from all over the world, tracing its history as it followed mankind from Africa. And it’s been a while: We brought whipworms with us during our initial migration into Asia and Europe over 50,000 years ago. When the Bering land bridge opened up and humanity moved into the Americas, the worms came as well.
This is all possible because the whipworm goes about its parasitic business quietly and cleverly. It mostly sits harmlessly in our digestive systems, producing thousands of eggs a day that get expelled through poop and picked up by another host (human or otherwise); whipworms only cause disease in those with compromised immune systems.
The researchers noted that their study, the first complete genetic analysis of the whipworm, could help combat the parasite, which to this day infects hundred of millions who don’t have access to modern medicine or sanitary conditions. Hopefully, though, the days of free rides will soon be over for the whipworm. After all, if we have to pay hundreds or thousands of dollars to visit other countries, it’s only fair that our parasites do as well.
From zero to vasectomy in 6.7 seconds
There’s an old saying that you’ve probably heard: When life gives you lemons, make lemonade. It’s meant to encourage optimism in the face of adversity. Then there’s the new saying we just made up: When life gives you a power outage, plug your surgical instruments into an electric pickup.
That’s what Dr. Christopher Yang did, and now we’re making the urologist from Austin, Tex., famous by sharing his surgical/electrical adventure with all 17 of LOTME’s regular readers. That’s some serious lemonade.
Dr. Yang’s tale begins when the electricity went out at his clinic, seemingly forcing him to cancel or reschedule several surgical procedures. Not so fast. Dr. Yang happens to own a Rivian R1T, an electric pickup truck that has four power outlets. A staff member suggested plugging the surgical instruments into the truck and, surprisingly, one of the day’s patients agreed to go ahead with his vasectomy.
“We were fortunate that my normal parking spot is close enough to a patient room to run an extension cord,” Dr. Yang said on TheDrive.com. That extension cord was attached to an electrocautery device, with a handheld device available as backup, and “after we were done, I told his family. We all had a good laugh together too,” Dr. Yang told radio station WGLT in Normal, Ill.
To us, anyway, this opens up all sorts of alternative energy possibilities. Can a windmill power a liposuction? Is a gerbil running in a wheel enough to do a colonoscopy? How many potatoes do you need to keep an EHR going?
Learning through random acts of not-exactly noisiness
First things first. Transcranial random noise stimulation (tRNS) is not really noise in the auditory sense of the word. For some people with learning disabilities, though, it can actually be very helpful. The technology, which uses electrodes attached to the head so a weak current can pass through specific parts of the brain, may help those with learning disabilities, perhaps even those with brain injuries and visual deficits, learn, said Dr. Onno van der Groen of Edith Cowan University in Perth, Australia.
“When you add this type of stimulation during learning, you get better performance, faster learning and better attention afterwards as well,” he said in a statement from the university.
The researchers say that tRNS can allow the brain to form new connections and pathways, which in turn help a person learn more effectively. “If you do 10 sessions of a visual perception task with the tRNS and then come back and do it again without it, you’ll find you perform better than the control group who hasn’t used it,” Dr. van der Groen noted.
Can this also work for the average person? It’s possible, but tRNS didn’t seem to improve the math skills of a top-level mathematician who underwent the process, according to a case study that Dr. van der Groen mentioned.
This line of work is still pretty new, though, so researchers don’t have all the answers yet. As always, we’re rooting for you, science!
Good news for pregnant women; bad news for fish
As soon as women find out they’re pregnant, doctors recommend they give up smoking, drinking, and eating certain types of fish. That last item may need to be reconsidered, since a recent study supports the idea that it doesn’t matter what type of fish pregnant women are eating, as long as they’re eating it.
Researchers collected data from two different studies that reviewed the mercury levels of mothers from Bristol, England, and the Seychelles, a island chain off East Africa where “fish consumption is high and prenatal mercury levels are 10 times higher than in the [United States],” they said in NeuroToxicology.
Those data showed that the mercury levels had no adverse effects on child development as long as the mother ate fish. The nutrients and vitamins in the fish – vitamin D, long-chain fatty acids, selenium, and iodine – provide protection against mercury. There’s also the already-known benefits to eyesight and intellectual abilities that have been associated with fish consumption.
This analysis goes starkly against the grain of what is commonly recommended to expectant mothers, which is to cut out fish altogether. The researchers suggested that governments should review and change those recommendations to focus on the benefits instead.
As long as women follow the researchers’ recommendation to eat “at least two portions of fish a week, one of which should be oily,” they may not have to lay off on the sushi after all.
We’ll show our gut worms the world
Never let it be said that mankind is not a generous species. Sure, we could maybe be kinder to our fellow human beings, maybe declare a little less war on each other, but for the past 50,000 years, we’ve been giving a free ride to millions upon millions to one of mankind’s closest companions: the whipworm.
This revelation into human kindness comes from Denmark, where researchers from Copenhagen conducted a genetic analysis of ancient preserved whipworm eggs found in old Viking and Norse settlements, some of which date back over 2,000 years. In normal conditions genetic material wouldn’t last very long, but these were Viking whipworms eggs with tiny little horned helmets, so the DNA within has remained unchanged. Or it may be the tough chitinous exterior of the eggs protecting the DNA from degrading, combined with their preservation in moist soil.
Once they had their Viking whipworm DNA, the researchers compared it with whipworm DNA from all over the world, tracing its history as it followed mankind from Africa. And it’s been a while: We brought whipworms with us during our initial migration into Asia and Europe over 50,000 years ago. When the Bering land bridge opened up and humanity moved into the Americas, the worms came as well.
This is all possible because the whipworm goes about its parasitic business quietly and cleverly. It mostly sits harmlessly in our digestive systems, producing thousands of eggs a day that get expelled through poop and picked up by another host (human or otherwise); whipworms only cause disease in those with compromised immune systems.
The researchers noted that their study, the first complete genetic analysis of the whipworm, could help combat the parasite, which to this day infects hundred of millions who don’t have access to modern medicine or sanitary conditions. Hopefully, though, the days of free rides will soon be over for the whipworm. After all, if we have to pay hundreds or thousands of dollars to visit other countries, it’s only fair that our parasites do as well.
From zero to vasectomy in 6.7 seconds
There’s an old saying that you’ve probably heard: When life gives you lemons, make lemonade. It’s meant to encourage optimism in the face of adversity. Then there’s the new saying we just made up: When life gives you a power outage, plug your surgical instruments into an electric pickup.
That’s what Dr. Christopher Yang did, and now we’re making the urologist from Austin, Tex., famous by sharing his surgical/electrical adventure with all 17 of LOTME’s regular readers. That’s some serious lemonade.
Dr. Yang’s tale begins when the electricity went out at his clinic, seemingly forcing him to cancel or reschedule several surgical procedures. Not so fast. Dr. Yang happens to own a Rivian R1T, an electric pickup truck that has four power outlets. A staff member suggested plugging the surgical instruments into the truck and, surprisingly, one of the day’s patients agreed to go ahead with his vasectomy.
“We were fortunate that my normal parking spot is close enough to a patient room to run an extension cord,” Dr. Yang said on TheDrive.com. That extension cord was attached to an electrocautery device, with a handheld device available as backup, and “after we were done, I told his family. We all had a good laugh together too,” Dr. Yang told radio station WGLT in Normal, Ill.
To us, anyway, this opens up all sorts of alternative energy possibilities. Can a windmill power a liposuction? Is a gerbil running in a wheel enough to do a colonoscopy? How many potatoes do you need to keep an EHR going?
Learning through random acts of not-exactly noisiness
First things first. Transcranial random noise stimulation (tRNS) is not really noise in the auditory sense of the word. For some people with learning disabilities, though, it can actually be very helpful. The technology, which uses electrodes attached to the head so a weak current can pass through specific parts of the brain, may help those with learning disabilities, perhaps even those with brain injuries and visual deficits, learn, said Dr. Onno van der Groen of Edith Cowan University in Perth, Australia.
“When you add this type of stimulation during learning, you get better performance, faster learning and better attention afterwards as well,” he said in a statement from the university.
The researchers say that tRNS can allow the brain to form new connections and pathways, which in turn help a person learn more effectively. “If you do 10 sessions of a visual perception task with the tRNS and then come back and do it again without it, you’ll find you perform better than the control group who hasn’t used it,” Dr. van der Groen noted.
Can this also work for the average person? It’s possible, but tRNS didn’t seem to improve the math skills of a top-level mathematician who underwent the process, according to a case study that Dr. van der Groen mentioned.
This line of work is still pretty new, though, so researchers don’t have all the answers yet. As always, we’re rooting for you, science!
Good news for pregnant women; bad news for fish
As soon as women find out they’re pregnant, doctors recommend they give up smoking, drinking, and eating certain types of fish. That last item may need to be reconsidered, since a recent study supports the idea that it doesn’t matter what type of fish pregnant women are eating, as long as they’re eating it.
Researchers collected data from two different studies that reviewed the mercury levels of mothers from Bristol, England, and the Seychelles, a island chain off East Africa where “fish consumption is high and prenatal mercury levels are 10 times higher than in the [United States],” they said in NeuroToxicology.
Those data showed that the mercury levels had no adverse effects on child development as long as the mother ate fish. The nutrients and vitamins in the fish – vitamin D, long-chain fatty acids, selenium, and iodine – provide protection against mercury. There’s also the already-known benefits to eyesight and intellectual abilities that have been associated with fish consumption.
This analysis goes starkly against the grain of what is commonly recommended to expectant mothers, which is to cut out fish altogether. The researchers suggested that governments should review and change those recommendations to focus on the benefits instead.
As long as women follow the researchers’ recommendation to eat “at least two portions of fish a week, one of which should be oily,” they may not have to lay off on the sushi after all.
We’ll show our gut worms the world
Never let it be said that mankind is not a generous species. Sure, we could maybe be kinder to our fellow human beings, maybe declare a little less war on each other, but for the past 50,000 years, we’ve been giving a free ride to millions upon millions to one of mankind’s closest companions: the whipworm.
This revelation into human kindness comes from Denmark, where researchers from Copenhagen conducted a genetic analysis of ancient preserved whipworm eggs found in old Viking and Norse settlements, some of which date back over 2,000 years. In normal conditions genetic material wouldn’t last very long, but these were Viking whipworms eggs with tiny little horned helmets, so the DNA within has remained unchanged. Or it may be the tough chitinous exterior of the eggs protecting the DNA from degrading, combined with their preservation in moist soil.
Once they had their Viking whipworm DNA, the researchers compared it with whipworm DNA from all over the world, tracing its history as it followed mankind from Africa. And it’s been a while: We brought whipworms with us during our initial migration into Asia and Europe over 50,000 years ago. When the Bering land bridge opened up and humanity moved into the Americas, the worms came as well.
This is all possible because the whipworm goes about its parasitic business quietly and cleverly. It mostly sits harmlessly in our digestive systems, producing thousands of eggs a day that get expelled through poop and picked up by another host (human or otherwise); whipworms only cause disease in those with compromised immune systems.
The researchers noted that their study, the first complete genetic analysis of the whipworm, could help combat the parasite, which to this day infects hundred of millions who don’t have access to modern medicine or sanitary conditions. Hopefully, though, the days of free rides will soon be over for the whipworm. After all, if we have to pay hundreds or thousands of dollars to visit other countries, it’s only fair that our parasites do as well.
From zero to vasectomy in 6.7 seconds
There’s an old saying that you’ve probably heard: When life gives you lemons, make lemonade. It’s meant to encourage optimism in the face of adversity. Then there’s the new saying we just made up: When life gives you a power outage, plug your surgical instruments into an electric pickup.
That’s what Dr. Christopher Yang did, and now we’re making the urologist from Austin, Tex., famous by sharing his surgical/electrical adventure with all 17 of LOTME’s regular readers. That’s some serious lemonade.
Dr. Yang’s tale begins when the electricity went out at his clinic, seemingly forcing him to cancel or reschedule several surgical procedures. Not so fast. Dr. Yang happens to own a Rivian R1T, an electric pickup truck that has four power outlets. A staff member suggested plugging the surgical instruments into the truck and, surprisingly, one of the day’s patients agreed to go ahead with his vasectomy.
“We were fortunate that my normal parking spot is close enough to a patient room to run an extension cord,” Dr. Yang said on TheDrive.com. That extension cord was attached to an electrocautery device, with a handheld device available as backup, and “after we were done, I told his family. We all had a good laugh together too,” Dr. Yang told radio station WGLT in Normal, Ill.
To us, anyway, this opens up all sorts of alternative energy possibilities. Can a windmill power a liposuction? Is a gerbil running in a wheel enough to do a colonoscopy? How many potatoes do you need to keep an EHR going?
Learning through random acts of not-exactly noisiness
First things first. Transcranial random noise stimulation (tRNS) is not really noise in the auditory sense of the word. For some people with learning disabilities, though, it can actually be very helpful. The technology, which uses electrodes attached to the head so a weak current can pass through specific parts of the brain, may help those with learning disabilities, perhaps even those with brain injuries and visual deficits, learn, said Dr. Onno van der Groen of Edith Cowan University in Perth, Australia.
“When you add this type of stimulation during learning, you get better performance, faster learning and better attention afterwards as well,” he said in a statement from the university.
The researchers say that tRNS can allow the brain to form new connections and pathways, which in turn help a person learn more effectively. “If you do 10 sessions of a visual perception task with the tRNS and then come back and do it again without it, you’ll find you perform better than the control group who hasn’t used it,” Dr. van der Groen noted.
Can this also work for the average person? It’s possible, but tRNS didn’t seem to improve the math skills of a top-level mathematician who underwent the process, according to a case study that Dr. van der Groen mentioned.
This line of work is still pretty new, though, so researchers don’t have all the answers yet. As always, we’re rooting for you, science!
Where a child eats breakfast is important
We’ve been told for decades that a child who doesn’t start the day with a good breakfast is entering school at a serious disadvantage. The brain needs a good supply of energy to learn optimally. So the standard wisdom goes. Subsidized school breakfast programs have been built around this chestnut. But, is there solid evidence to support the notion that simply adding a morning meal to a child’s schedule will improve his or her school performance? It sounds like common sense, but is it just one of those old grandmother’s nuggets that doesn’t stand up under close scrutiny?
A recent study from Spain suggests that the relationship between breakfast and school performance is not merely related to the nutritional needs of a growing brain. Using data from nearly 4,000 Spanish children aged 4-14 collected in a 2017 national health survey, the investigators found “skipping breakfast and eating breakfast out of the home were linked to greater odds of psychosocial behavioral problems than eating breakfast at home.” And, we already know that, in general, children who misbehave in school don’t thrive academically.
There were also associations between the absence or presence of certain food groups in the morning meal with behavioral problems. But the data lacked the granularity to draw any firm conclusions – although the authors felt that what they consider a healthy Spanish diet may have had a positive influence on behavior.
The findings in this study may simply be another example of the many positive influences that have been associated with family meals and have little to do with what is actually consumed. The association may not have much to do with the family gathering together at a single Norman Rockwell sitting, a reality that I suspect seldom occurs. The apparent positive influence of breakfast may be that it reflects a family’s priorities: that food is important, that sleep is important, and that school is important – so important that scheduling the morning should focus on sending the child off well prepared. The child who is allowed to stay up to an unhealthy hour is likely to be difficult to arouse in the morning for breakfast and getting off to school.
It may be that the child’s behavior problems are so disruptive and taxing for the family that even with their best efforts, the parents can’t find the time and energy to provide a breakfast in the home.
On the other hand, the study doesn’t tell us how many children aren’t offered breakfast at home because their families simply can’t afford it. Obviously, the answer depends on the socioeconomic mix of a given community. In some localities this may represent a sizable percentage of the population.
So where does this leave us? Unfortunately, as I read through the discussion at the end of this paper I felt that the authors were leaning too much toward further research based on the potential associations between behavior and specific food groups their data suggested.
For me, the take-home message from this paper is that our existing efforts to improve academic success with food offered in school should also include strategies that promote eating breakfast at home. For example, the backpack take-home food distribution programs that seem to have been effective could include breakfast-targeted items packaged in a way that encourage families to provide breakfast at home.
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.
We’ve been told for decades that a child who doesn’t start the day with a good breakfast is entering school at a serious disadvantage. The brain needs a good supply of energy to learn optimally. So the standard wisdom goes. Subsidized school breakfast programs have been built around this chestnut. But, is there solid evidence to support the notion that simply adding a morning meal to a child’s schedule will improve his or her school performance? It sounds like common sense, but is it just one of those old grandmother’s nuggets that doesn’t stand up under close scrutiny?
A recent study from Spain suggests that the relationship between breakfast and school performance is not merely related to the nutritional needs of a growing brain. Using data from nearly 4,000 Spanish children aged 4-14 collected in a 2017 national health survey, the investigators found “skipping breakfast and eating breakfast out of the home were linked to greater odds of psychosocial behavioral problems than eating breakfast at home.” And, we already know that, in general, children who misbehave in school don’t thrive academically.
There were also associations between the absence or presence of certain food groups in the morning meal with behavioral problems. But the data lacked the granularity to draw any firm conclusions – although the authors felt that what they consider a healthy Spanish diet may have had a positive influence on behavior.
The findings in this study may simply be another example of the many positive influences that have been associated with family meals and have little to do with what is actually consumed. The association may not have much to do with the family gathering together at a single Norman Rockwell sitting, a reality that I suspect seldom occurs. The apparent positive influence of breakfast may be that it reflects a family’s priorities: that food is important, that sleep is important, and that school is important – so important that scheduling the morning should focus on sending the child off well prepared. The child who is allowed to stay up to an unhealthy hour is likely to be difficult to arouse in the morning for breakfast and getting off to school.
It may be that the child’s behavior problems are so disruptive and taxing for the family that even with their best efforts, the parents can’t find the time and energy to provide a breakfast in the home.
On the other hand, the study doesn’t tell us how many children aren’t offered breakfast at home because their families simply can’t afford it. Obviously, the answer depends on the socioeconomic mix of a given community. In some localities this may represent a sizable percentage of the population.
So where does this leave us? Unfortunately, as I read through the discussion at the end of this paper I felt that the authors were leaning too much toward further research based on the potential associations between behavior and specific food groups their data suggested.
For me, the take-home message from this paper is that our existing efforts to improve academic success with food offered in school should also include strategies that promote eating breakfast at home. For example, the backpack take-home food distribution programs that seem to have been effective could include breakfast-targeted items packaged in a way that encourage families to provide breakfast at home.
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.
We’ve been told for decades that a child who doesn’t start the day with a good breakfast is entering school at a serious disadvantage. The brain needs a good supply of energy to learn optimally. So the standard wisdom goes. Subsidized school breakfast programs have been built around this chestnut. But, is there solid evidence to support the notion that simply adding a morning meal to a child’s schedule will improve his or her school performance? It sounds like common sense, but is it just one of those old grandmother’s nuggets that doesn’t stand up under close scrutiny?
A recent study from Spain suggests that the relationship between breakfast and school performance is not merely related to the nutritional needs of a growing brain. Using data from nearly 4,000 Spanish children aged 4-14 collected in a 2017 national health survey, the investigators found “skipping breakfast and eating breakfast out of the home were linked to greater odds of psychosocial behavioral problems than eating breakfast at home.” And, we already know that, in general, children who misbehave in school don’t thrive academically.
There were also associations between the absence or presence of certain food groups in the morning meal with behavioral problems. But the data lacked the granularity to draw any firm conclusions – although the authors felt that what they consider a healthy Spanish diet may have had a positive influence on behavior.
The findings in this study may simply be another example of the many positive influences that have been associated with family meals and have little to do with what is actually consumed. The association may not have much to do with the family gathering together at a single Norman Rockwell sitting, a reality that I suspect seldom occurs. The apparent positive influence of breakfast may be that it reflects a family’s priorities: that food is important, that sleep is important, and that school is important – so important that scheduling the morning should focus on sending the child off well prepared. The child who is allowed to stay up to an unhealthy hour is likely to be difficult to arouse in the morning for breakfast and getting off to school.
It may be that the child’s behavior problems are so disruptive and taxing for the family that even with their best efforts, the parents can’t find the time and energy to provide a breakfast in the home.
On the other hand, the study doesn’t tell us how many children aren’t offered breakfast at home because their families simply can’t afford it. Obviously, the answer depends on the socioeconomic mix of a given community. In some localities this may represent a sizable percentage of the population.
So where does this leave us? Unfortunately, as I read through the discussion at the end of this paper I felt that the authors were leaning too much toward further research based on the potential associations between behavior and specific food groups their data suggested.
For me, the take-home message from this paper is that our existing efforts to improve academic success with food offered in school should also include strategies that promote eating breakfast at home. For example, the backpack take-home food distribution programs that seem to have been effective could include breakfast-targeted items packaged in a way that encourage families to provide breakfast at home.
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.
Pediatricians urge flu vaccine for children
Attention parents: The nation’s leading pediatric medical society is urging you to make sure your children get a flu shot this fall to prevent and control the spread of the illness.
The American Academy of Pediatrics recently called on parents and caregivers to seek flu vaccines for their children as soon as they are available in the fall. The group is encouraging parents to catch up on all other vaccines for their children, too.
“As a pediatrician and a parent, I consider the flu vaccine as critical for all family members,” Kristina A. Bryant, MD, said in a statement about the academy’s recommendations. “We should not underestimate the flu, especially when other respiratory viruses like COVID-19 are circulating within our communities. Besides making your child miserable and wreaking havoc on your family’s routine, influenza can also be serious and even deadly in children.”
Only 55% of children aged 6 months to 17 years had been vaccinated against influenza as of early April – down 2% from the previous April – and coverage levels were 8.1% lower for Black children compared with non-Hispanic White children, according to the CDC. In the 2019-2020 flu season, 188 children in the United States died of the infection, equaling the high mark for deaths set in the 2017-2018 season, the agency reported.
American Academy of Pediatrics guidelines recommend children aged 6 months and older be vaccinated with the flu vaccine every year. Depending on the child’s age and health, they may receive either a shot, which has an inactive version of the flu virus, or the nasal spray, which has a weakened form of the virus. The academy has more information about the different vaccines.
Children aged 6-8 months who are getting flu vaccines for the first time should receive two doses at least 4 weeks apart. Pregnant women can get the flu vaccine any time in their pregnancy. Influenza vaccines are safe for developing fetuses, according to the academy.
The group stressed the importance of flu vaccines for high-risk and medically vulnerable children and acknowledged the need to end barriers to immunizations for all people, regardless of income or insurance coverage. In 2020, an estimated 16.1% of children in the United States were living in poverty, up from 14.4% in 2019, according to the U.S. Census Bureau.
A version of this article first appeared on WebMD.com.
Attention parents: The nation’s leading pediatric medical society is urging you to make sure your children get a flu shot this fall to prevent and control the spread of the illness.
The American Academy of Pediatrics recently called on parents and caregivers to seek flu vaccines for their children as soon as they are available in the fall. The group is encouraging parents to catch up on all other vaccines for their children, too.
“As a pediatrician and a parent, I consider the flu vaccine as critical for all family members,” Kristina A. Bryant, MD, said in a statement about the academy’s recommendations. “We should not underestimate the flu, especially when other respiratory viruses like COVID-19 are circulating within our communities. Besides making your child miserable and wreaking havoc on your family’s routine, influenza can also be serious and even deadly in children.”
Only 55% of children aged 6 months to 17 years had been vaccinated against influenza as of early April – down 2% from the previous April – and coverage levels were 8.1% lower for Black children compared with non-Hispanic White children, according to the CDC. In the 2019-2020 flu season, 188 children in the United States died of the infection, equaling the high mark for deaths set in the 2017-2018 season, the agency reported.
American Academy of Pediatrics guidelines recommend children aged 6 months and older be vaccinated with the flu vaccine every year. Depending on the child’s age and health, they may receive either a shot, which has an inactive version of the flu virus, or the nasal spray, which has a weakened form of the virus. The academy has more information about the different vaccines.
Children aged 6-8 months who are getting flu vaccines for the first time should receive two doses at least 4 weeks apart. Pregnant women can get the flu vaccine any time in their pregnancy. Influenza vaccines are safe for developing fetuses, according to the academy.
The group stressed the importance of flu vaccines for high-risk and medically vulnerable children and acknowledged the need to end barriers to immunizations for all people, regardless of income or insurance coverage. In 2020, an estimated 16.1% of children in the United States were living in poverty, up from 14.4% in 2019, according to the U.S. Census Bureau.
A version of this article first appeared on WebMD.com.
Attention parents: The nation’s leading pediatric medical society is urging you to make sure your children get a flu shot this fall to prevent and control the spread of the illness.
The American Academy of Pediatrics recently called on parents and caregivers to seek flu vaccines for their children as soon as they are available in the fall. The group is encouraging parents to catch up on all other vaccines for their children, too.
“As a pediatrician and a parent, I consider the flu vaccine as critical for all family members,” Kristina A. Bryant, MD, said in a statement about the academy’s recommendations. “We should not underestimate the flu, especially when other respiratory viruses like COVID-19 are circulating within our communities. Besides making your child miserable and wreaking havoc on your family’s routine, influenza can also be serious and even deadly in children.”
Only 55% of children aged 6 months to 17 years had been vaccinated against influenza as of early April – down 2% from the previous April – and coverage levels were 8.1% lower for Black children compared with non-Hispanic White children, according to the CDC. In the 2019-2020 flu season, 188 children in the United States died of the infection, equaling the high mark for deaths set in the 2017-2018 season, the agency reported.
American Academy of Pediatrics guidelines recommend children aged 6 months and older be vaccinated with the flu vaccine every year. Depending on the child’s age and health, they may receive either a shot, which has an inactive version of the flu virus, or the nasal spray, which has a weakened form of the virus. The academy has more information about the different vaccines.
Children aged 6-8 months who are getting flu vaccines for the first time should receive two doses at least 4 weeks apart. Pregnant women can get the flu vaccine any time in their pregnancy. Influenza vaccines are safe for developing fetuses, according to the academy.
The group stressed the importance of flu vaccines for high-risk and medically vulnerable children and acknowledged the need to end barriers to immunizations for all people, regardless of income or insurance coverage. In 2020, an estimated 16.1% of children in the United States were living in poverty, up from 14.4% in 2019, according to the U.S. Census Bureau.
A version of this article first appeared on WebMD.com.
Five contract red flags every physician should know
Recruiting health care workers is a challenge these days for both private practice and hospital employers, and competition can be fierce. In order to be competitive, employers need to review the package they are offering potential candidates and understand that it’s more than just compensation and benefits that matter.
As someone who reviews physician contracts extensively, there are some common examples of language that may cause a candidate to choose a different position.
Probationary period
Although every employer wants to find out if they like the physician or midlevel employee that they have just hired before fully committing, the inclusion of a probationary period (usually 90 days) is offensive to a candidate, especially one with a choice of contracts.
Essentially, the employer is asking the employee to (potentially) relocate, go through the credentialing process, and turn down other potential offers, all for the possibility that they could easily be terminated. Probationary periods typically allow an employee to be immediately terminated without notice or cause, which can then leave them stranded without a paycheck (and with a new home and/or other recent commitments).
Moreover, contracts with probationary periods tend to terminate the employee without covering any tail costs or clarifying that the employer will not enforce restrictive provisions (even if unlikely to be legally enforceable based on the short relationship).
It is important to understand that the process of a person finding a new position, which includes interviewing, contract negotiation, and credentialing, can take up to 6 months. For this reason, probationary provisions create real job insecurity for a candidate.
Entering into a new affiliation is a leap of faith both for the employer and the employee. If the circumstances do not work out, the employer should fairly compensate the employee for the notice period and ask them not to return to work or otherwise allow them to keep working the notice period while they search for a new position.
Acceleration of notice
Another objectionable provision that employers like to include in their contracts is one which allows the employer to accelerate and immediately terminate an employee who has given proper notice.
The contract will contain a standard notice provision, but when the health care professional submits notice, their last date is suddenly accelerated, and they are released without further compensation, notice, or benefits. This type of provision is particularly offensive to health care employees who take the step of giving proper contractual notice and, similar to the probationary language, can create real job insecurity for an employee who suddenly loses their paycheck and has no new job to start.
Medical workers should be paid for the entire notice period whether or not they are allowed to work. Unfortunately, this type of provision is sometimes hidden in contracts and not noticed by employees, who tend to focus on the notice provision itself. I consider this provision to be a red flag about the employer when I review clients’ contracts.
Malpractice tail
Although many employers will claim it is not unusual for an employee to pay for their own malpractice tail, in the current marketplace, the payment of tail can be a deciding factor in whether a candidate accepts a contract.
At a minimum, employers should consider paying for the tail under circumstances where they non-renew a contract, terminate without cause, or the contract is terminated for the employer’s breach. Similarly, I like to seek out payment of the tail by the employer where the contract is terminated owing to a change in the law, use of a force majeure provision, loss of the employer’s hospital contract, or similar provisions where termination is outside the control of the employee.
Employers should also consider a provision where they share the cost of a tail or cover the entire cost on the basis of years of service in order to stand out to a potential candidate.
Noncompete provisions
I do not find noncompete provisions to be generally unacceptable when properly written; however, employers should reevaluate the reasonableness of their noncompete language frequently, because such language can make the difference in whether a candidate accepts a contract.
A reasonable noncompete that only protects the employer as necessary and does not restrict the reasonable practice of medicine is always preferable and can be the deciding factor for a candidate. Tying enforcement of a noncompete to reasons for termination (similar to the tail) can also make a positive difference in a candidate’s review of a contract.
Egregious noncompetes, where the candidate is simply informed that the language is “not negotiable,” are unlikely to be compelling to a candidate with other options.
Specifics on location, call, schedule
One item potential employees find extremely frustrating about contracts is when it fails to include promises made regarding location, call, and schedule.
These particular items affect a physician’s expectations about a job, including commute time, family life, and lifestyle. An employer or recruiter that makes a lot of promises on these points but won’t commit to the details in writing (or at least offer mutual agreement on these issues) can cause an uncertain candidate to choose the job that offers greater certainty.
There are many provisions of a contract that can make a difference to a particular job applicant. A savvy employer seeking to capture a particular health care professional should find out what the specific goals and needs of the candidate might be and consider adjusting the contract to best satisfy the candidate.
At the end of the day, however, at least for those physicians and others reviewing contracts that are fairly equivalent, it may be the fairness of the contract provisions that end up being the deciding factor.
Ms. Adler is Health Law Group Practice Leader for the law firm Roetzel in Chicago. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Recruiting health care workers is a challenge these days for both private practice and hospital employers, and competition can be fierce. In order to be competitive, employers need to review the package they are offering potential candidates and understand that it’s more than just compensation and benefits that matter.
As someone who reviews physician contracts extensively, there are some common examples of language that may cause a candidate to choose a different position.
Probationary period
Although every employer wants to find out if they like the physician or midlevel employee that they have just hired before fully committing, the inclusion of a probationary period (usually 90 days) is offensive to a candidate, especially one with a choice of contracts.
Essentially, the employer is asking the employee to (potentially) relocate, go through the credentialing process, and turn down other potential offers, all for the possibility that they could easily be terminated. Probationary periods typically allow an employee to be immediately terminated without notice or cause, which can then leave them stranded without a paycheck (and with a new home and/or other recent commitments).
Moreover, contracts with probationary periods tend to terminate the employee without covering any tail costs or clarifying that the employer will not enforce restrictive provisions (even if unlikely to be legally enforceable based on the short relationship).
It is important to understand that the process of a person finding a new position, which includes interviewing, contract negotiation, and credentialing, can take up to 6 months. For this reason, probationary provisions create real job insecurity for a candidate.
Entering into a new affiliation is a leap of faith both for the employer and the employee. If the circumstances do not work out, the employer should fairly compensate the employee for the notice period and ask them not to return to work or otherwise allow them to keep working the notice period while they search for a new position.
Acceleration of notice
Another objectionable provision that employers like to include in their contracts is one which allows the employer to accelerate and immediately terminate an employee who has given proper notice.
The contract will contain a standard notice provision, but when the health care professional submits notice, their last date is suddenly accelerated, and they are released without further compensation, notice, or benefits. This type of provision is particularly offensive to health care employees who take the step of giving proper contractual notice and, similar to the probationary language, can create real job insecurity for an employee who suddenly loses their paycheck and has no new job to start.
Medical workers should be paid for the entire notice period whether or not they are allowed to work. Unfortunately, this type of provision is sometimes hidden in contracts and not noticed by employees, who tend to focus on the notice provision itself. I consider this provision to be a red flag about the employer when I review clients’ contracts.
Malpractice tail
Although many employers will claim it is not unusual for an employee to pay for their own malpractice tail, in the current marketplace, the payment of tail can be a deciding factor in whether a candidate accepts a contract.
At a minimum, employers should consider paying for the tail under circumstances where they non-renew a contract, terminate without cause, or the contract is terminated for the employer’s breach. Similarly, I like to seek out payment of the tail by the employer where the contract is terminated owing to a change in the law, use of a force majeure provision, loss of the employer’s hospital contract, or similar provisions where termination is outside the control of the employee.
Employers should also consider a provision where they share the cost of a tail or cover the entire cost on the basis of years of service in order to stand out to a potential candidate.
Noncompete provisions
I do not find noncompete provisions to be generally unacceptable when properly written; however, employers should reevaluate the reasonableness of their noncompete language frequently, because such language can make the difference in whether a candidate accepts a contract.
A reasonable noncompete that only protects the employer as necessary and does not restrict the reasonable practice of medicine is always preferable and can be the deciding factor for a candidate. Tying enforcement of a noncompete to reasons for termination (similar to the tail) can also make a positive difference in a candidate’s review of a contract.
Egregious noncompetes, where the candidate is simply informed that the language is “not negotiable,” are unlikely to be compelling to a candidate with other options.
Specifics on location, call, schedule
One item potential employees find extremely frustrating about contracts is when it fails to include promises made regarding location, call, and schedule.
These particular items affect a physician’s expectations about a job, including commute time, family life, and lifestyle. An employer or recruiter that makes a lot of promises on these points but won’t commit to the details in writing (or at least offer mutual agreement on these issues) can cause an uncertain candidate to choose the job that offers greater certainty.
There are many provisions of a contract that can make a difference to a particular job applicant. A savvy employer seeking to capture a particular health care professional should find out what the specific goals and needs of the candidate might be and consider adjusting the contract to best satisfy the candidate.
At the end of the day, however, at least for those physicians and others reviewing contracts that are fairly equivalent, it may be the fairness of the contract provisions that end up being the deciding factor.
Ms. Adler is Health Law Group Practice Leader for the law firm Roetzel in Chicago. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Recruiting health care workers is a challenge these days for both private practice and hospital employers, and competition can be fierce. In order to be competitive, employers need to review the package they are offering potential candidates and understand that it’s more than just compensation and benefits that matter.
As someone who reviews physician contracts extensively, there are some common examples of language that may cause a candidate to choose a different position.
Probationary period
Although every employer wants to find out if they like the physician or midlevel employee that they have just hired before fully committing, the inclusion of a probationary period (usually 90 days) is offensive to a candidate, especially one with a choice of contracts.
Essentially, the employer is asking the employee to (potentially) relocate, go through the credentialing process, and turn down other potential offers, all for the possibility that they could easily be terminated. Probationary periods typically allow an employee to be immediately terminated without notice or cause, which can then leave them stranded without a paycheck (and with a new home and/or other recent commitments).
Moreover, contracts with probationary periods tend to terminate the employee without covering any tail costs or clarifying that the employer will not enforce restrictive provisions (even if unlikely to be legally enforceable based on the short relationship).
It is important to understand that the process of a person finding a new position, which includes interviewing, contract negotiation, and credentialing, can take up to 6 months. For this reason, probationary provisions create real job insecurity for a candidate.
Entering into a new affiliation is a leap of faith both for the employer and the employee. If the circumstances do not work out, the employer should fairly compensate the employee for the notice period and ask them not to return to work or otherwise allow them to keep working the notice period while they search for a new position.
Acceleration of notice
Another objectionable provision that employers like to include in their contracts is one which allows the employer to accelerate and immediately terminate an employee who has given proper notice.
The contract will contain a standard notice provision, but when the health care professional submits notice, their last date is suddenly accelerated, and they are released without further compensation, notice, or benefits. This type of provision is particularly offensive to health care employees who take the step of giving proper contractual notice and, similar to the probationary language, can create real job insecurity for an employee who suddenly loses their paycheck and has no new job to start.
Medical workers should be paid for the entire notice period whether or not they are allowed to work. Unfortunately, this type of provision is sometimes hidden in contracts and not noticed by employees, who tend to focus on the notice provision itself. I consider this provision to be a red flag about the employer when I review clients’ contracts.
Malpractice tail
Although many employers will claim it is not unusual for an employee to pay for their own malpractice tail, in the current marketplace, the payment of tail can be a deciding factor in whether a candidate accepts a contract.
At a minimum, employers should consider paying for the tail under circumstances where they non-renew a contract, terminate without cause, or the contract is terminated for the employer’s breach. Similarly, I like to seek out payment of the tail by the employer where the contract is terminated owing to a change in the law, use of a force majeure provision, loss of the employer’s hospital contract, or similar provisions where termination is outside the control of the employee.
Employers should also consider a provision where they share the cost of a tail or cover the entire cost on the basis of years of service in order to stand out to a potential candidate.
Noncompete provisions
I do not find noncompete provisions to be generally unacceptable when properly written; however, employers should reevaluate the reasonableness of their noncompete language frequently, because such language can make the difference in whether a candidate accepts a contract.
A reasonable noncompete that only protects the employer as necessary and does not restrict the reasonable practice of medicine is always preferable and can be the deciding factor for a candidate. Tying enforcement of a noncompete to reasons for termination (similar to the tail) can also make a positive difference in a candidate’s review of a contract.
Egregious noncompetes, where the candidate is simply informed that the language is “not negotiable,” are unlikely to be compelling to a candidate with other options.
Specifics on location, call, schedule
One item potential employees find extremely frustrating about contracts is when it fails to include promises made regarding location, call, and schedule.
These particular items affect a physician’s expectations about a job, including commute time, family life, and lifestyle. An employer or recruiter that makes a lot of promises on these points but won’t commit to the details in writing (or at least offer mutual agreement on these issues) can cause an uncertain candidate to choose the job that offers greater certainty.
There are many provisions of a contract that can make a difference to a particular job applicant. A savvy employer seeking to capture a particular health care professional should find out what the specific goals and needs of the candidate might be and consider adjusting the contract to best satisfy the candidate.
At the end of the day, however, at least for those physicians and others reviewing contracts that are fairly equivalent, it may be the fairness of the contract provisions that end up being the deciding factor.
Ms. Adler is Health Law Group Practice Leader for the law firm Roetzel in Chicago. She reported no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Children and COVID: Weekly cases close out August with a second straight increase
New cases rose by 4.6% for the week of Aug. 26 to Sept. 1, following a week in which cases increased by almost 9%, as the second half of August basically reversed the two consecutive weeks of decreases during the first half of the month, based on the AAP/CHA data collected from state and territorial health departments.
Similar trends can be seen for emergency department visits, with the exception of children aged 0-11 years, whose ED visit rates have continued to fall since late July. Children aged 12-15, however, had a 7-day average of 4.4% of ED visits with diagnosed COVID on Aug. 25, compared with 3.1% for Aug. 12. Children aged 16-17 years were at 3.4% on Aug. 27, compared with 3.1% as late as Aug. 15, the Centers for Disease Control and Prevention reported.
Hospital admissions with confirmed COVID-19, reported only for children aged 0-17 years, also reflect the late-August trend of increased cases. New hospitalizations dropped from 0.46 per 100,000 population on July 30 to 0.40 per 100,000 on Aug. 19 but have since risen to 0.44 per 100,000 as of Aug. 27, the CDC said on its COVID Data Tracker.
Initial vaccinations, meanwhile, have declined since early August for all children, according to a separate report from the AAP. A look at CDC data for two specific days – the first and last Mondays of the month – shows that those aged under 5 received 12,982 doses on Aug. 1, compared with 5,824 doses on Aug. 29. Over that same time, initial vaccinations in 5- to 11-year-olds went from 9,058 to 2,879, while among those aged 12-17 they dropped from 4,245 to 1,226.
Cumulatively, 5.5% of all children under age 5 had received at least one dose and 1.3% were fully vaccinated by Aug. 30, compared with 38.1% and 30.7%, respectively, of those aged 5-11 and 70.7% and 60.5% of 12- to 17-year-olds, the CDC said.
New cases rose by 4.6% for the week of Aug. 26 to Sept. 1, following a week in which cases increased by almost 9%, as the second half of August basically reversed the two consecutive weeks of decreases during the first half of the month, based on the AAP/CHA data collected from state and territorial health departments.
Similar trends can be seen for emergency department visits, with the exception of children aged 0-11 years, whose ED visit rates have continued to fall since late July. Children aged 12-15, however, had a 7-day average of 4.4% of ED visits with diagnosed COVID on Aug. 25, compared with 3.1% for Aug. 12. Children aged 16-17 years were at 3.4% on Aug. 27, compared with 3.1% as late as Aug. 15, the Centers for Disease Control and Prevention reported.
Hospital admissions with confirmed COVID-19, reported only for children aged 0-17 years, also reflect the late-August trend of increased cases. New hospitalizations dropped from 0.46 per 100,000 population on July 30 to 0.40 per 100,000 on Aug. 19 but have since risen to 0.44 per 100,000 as of Aug. 27, the CDC said on its COVID Data Tracker.
Initial vaccinations, meanwhile, have declined since early August for all children, according to a separate report from the AAP. A look at CDC data for two specific days – the first and last Mondays of the month – shows that those aged under 5 received 12,982 doses on Aug. 1, compared with 5,824 doses on Aug. 29. Over that same time, initial vaccinations in 5- to 11-year-olds went from 9,058 to 2,879, while among those aged 12-17 they dropped from 4,245 to 1,226.
Cumulatively, 5.5% of all children under age 5 had received at least one dose and 1.3% were fully vaccinated by Aug. 30, compared with 38.1% and 30.7%, respectively, of those aged 5-11 and 70.7% and 60.5% of 12- to 17-year-olds, the CDC said.
New cases rose by 4.6% for the week of Aug. 26 to Sept. 1, following a week in which cases increased by almost 9%, as the second half of August basically reversed the two consecutive weeks of decreases during the first half of the month, based on the AAP/CHA data collected from state and territorial health departments.
Similar trends can be seen for emergency department visits, with the exception of children aged 0-11 years, whose ED visit rates have continued to fall since late July. Children aged 12-15, however, had a 7-day average of 4.4% of ED visits with diagnosed COVID on Aug. 25, compared with 3.1% for Aug. 12. Children aged 16-17 years were at 3.4% on Aug. 27, compared with 3.1% as late as Aug. 15, the Centers for Disease Control and Prevention reported.
Hospital admissions with confirmed COVID-19, reported only for children aged 0-17 years, also reflect the late-August trend of increased cases. New hospitalizations dropped from 0.46 per 100,000 population on July 30 to 0.40 per 100,000 on Aug. 19 but have since risen to 0.44 per 100,000 as of Aug. 27, the CDC said on its COVID Data Tracker.
Initial vaccinations, meanwhile, have declined since early August for all children, according to a separate report from the AAP. A look at CDC data for two specific days – the first and last Mondays of the month – shows that those aged under 5 received 12,982 doses on Aug. 1, compared with 5,824 doses on Aug. 29. Over that same time, initial vaccinations in 5- to 11-year-olds went from 9,058 to 2,879, while among those aged 12-17 they dropped from 4,245 to 1,226.
Cumulatively, 5.5% of all children under age 5 had received at least one dose and 1.3% were fully vaccinated by Aug. 30, compared with 38.1% and 30.7%, respectively, of those aged 5-11 and 70.7% and 60.5% of 12- to 17-year-olds, the CDC said.
Reduced-lactose infant formula related to higher risk of obesity later
Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new research shows.
Infants who drink infant formula instead of breast milk already carry an increased risk of obesity. But the new study, published in The American Journal of Clinical Nutrition, found a difference in types of formula and obesity outcomes for children.
Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; P = .02) of being obese by age 2 than infants who received regular cow’s milk formula.
“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”
Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.
“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is lactose intolerant, but they are not,” Dr. Corkins said.
Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC.
Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic.
Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; P = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; P = .01).
Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain.
She explained that babies who receive formula have higher obesity risk than babies who are breastfed overall. But research into the effects of different types of formula is relatively new. She said there may be a few reasons for the association between reduced-lactose, corn syrup solid formula and a higher risk of obesity.
“The addition of the corn syrup really starts to potentially teach that child to like sweet things,” Dr. Williams said, which in turn can lead to less healthy eating habits in childhood and adulthood.
Or, it may be that parents who tend to give their children lactose-reduced formula are less likely to be tolerant of fussy babies and end up feeding their babies more, Dr. Williams hypothesized.
In addition, emerging research shows corn syrup may act differently from other sugars in the gut microbiome and as it is metabolized in the liver, leading to weight gain.
Although parents make individual choices for what kind of formula to feed their infants, states play a large role in these choices. In 2018, 45% of babies in the United States were eligible for WIC, which is funded through the federal government but administered by states. State WIC programs request bids from formula manufacturers, and products chosen are then redeemed at retailers by parents.
“Now that we’re starting to see a signal that perhaps some formulas will have a potentially added risk of obesity for participants, states may say that when we’re helping mothers select among the formulas, we need to be very explicit about this additional risk,” said Christopher Anderson, PhD, MSPH, associate research scientist at the southern California Public Health Foundation Enterprises WIC and lead author of the study.
Dr. Williams said more research to do similar analyses in other populations is needed to draw cause and effect conclusions, while Dr. Corkins said he’d like to see more research into the amount of formula eaten and health connections to types of formula.
“We know as soon as you sign up for a baby registry at Target, you’re getting formula samples in the mail. You’re very aggressively marketed to; it’s a $55 billion industry,” Dr. Williams said. “And their goal is to sell their product – not to promote the health of infants. “This research certainly will cause us to pause and consider what we are feeding our infants in the United States and how we allow companies to market their products.”
Dr. Goran receives book royalties from Penguin Random House and is a scientific consultant for Yumi Foods and Else Nutrition. All other authors disclosed no conflicts of interest. Dr. Corkins reports working at a clinic that’s the site of a Takeda pharmaceutical research study. Dr. Williams reports no relevant financial relationships.
Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new research shows.
Infants who drink infant formula instead of breast milk already carry an increased risk of obesity. But the new study, published in The American Journal of Clinical Nutrition, found a difference in types of formula and obesity outcomes for children.
Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; P = .02) of being obese by age 2 than infants who received regular cow’s milk formula.
“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”
Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.
“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is lactose intolerant, but they are not,” Dr. Corkins said.
Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC.
Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic.
Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; P = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; P = .01).
Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain.
She explained that babies who receive formula have higher obesity risk than babies who are breastfed overall. But research into the effects of different types of formula is relatively new. She said there may be a few reasons for the association between reduced-lactose, corn syrup solid formula and a higher risk of obesity.
“The addition of the corn syrup really starts to potentially teach that child to like sweet things,” Dr. Williams said, which in turn can lead to less healthy eating habits in childhood and adulthood.
Or, it may be that parents who tend to give their children lactose-reduced formula are less likely to be tolerant of fussy babies and end up feeding their babies more, Dr. Williams hypothesized.
In addition, emerging research shows corn syrup may act differently from other sugars in the gut microbiome and as it is metabolized in the liver, leading to weight gain.
Although parents make individual choices for what kind of formula to feed their infants, states play a large role in these choices. In 2018, 45% of babies in the United States were eligible for WIC, which is funded through the federal government but administered by states. State WIC programs request bids from formula manufacturers, and products chosen are then redeemed at retailers by parents.
“Now that we’re starting to see a signal that perhaps some formulas will have a potentially added risk of obesity for participants, states may say that when we’re helping mothers select among the formulas, we need to be very explicit about this additional risk,” said Christopher Anderson, PhD, MSPH, associate research scientist at the southern California Public Health Foundation Enterprises WIC and lead author of the study.
Dr. Williams said more research to do similar analyses in other populations is needed to draw cause and effect conclusions, while Dr. Corkins said he’d like to see more research into the amount of formula eaten and health connections to types of formula.
“We know as soon as you sign up for a baby registry at Target, you’re getting formula samples in the mail. You’re very aggressively marketed to; it’s a $55 billion industry,” Dr. Williams said. “And their goal is to sell their product – not to promote the health of infants. “This research certainly will cause us to pause and consider what we are feeding our infants in the United States and how we allow companies to market their products.”
Dr. Goran receives book royalties from Penguin Random House and is a scientific consultant for Yumi Foods and Else Nutrition. All other authors disclosed no conflicts of interest. Dr. Corkins reports working at a clinic that’s the site of a Takeda pharmaceutical research study. Dr. Williams reports no relevant financial relationships.
Doctors may want to advise parents against giving their infants lactose-reduced infant formula unless absolutely necessary, because doing so may be setting babies up for an increased risk of obesity in toddlerhood, new research shows.
Infants who drink infant formula instead of breast milk already carry an increased risk of obesity. But the new study, published in The American Journal of Clinical Nutrition, found a difference in types of formula and obesity outcomes for children.
Babies under 1 year who received lactose-reduced formula made partially of corn syrup solids were at a 10% greater risk (risk ratio, 1.10; 95% confidence interval, 1.02, 1.20; P = .02) of being obese by age 2 than infants who received regular cow’s milk formula.
“This is even another reason to not use a low-lactose formula,” said Mark R. Corkins, MD, division chief of pediatric gastroenterology, hepatology, and nutrition at the University of Tennessee Health Science Center, Memphis, who was not involved in the study. “Parents think if babies are fussy, or they spit up, they have lactose intolerance, but if you look at the actual numbers, lactose intolerance in infants is rare.”
Actual lactose intolerance in infancy is the result of a newborn receiving the same mutated gene from both parents, called congenital lactase deficiency, said Dr. Corkins.
“The reason the low-lactose formulas are even on the market is because parents want them, and they think their kid is lactose intolerant, but they are not,” Dr. Corkins said.
Researchers from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) in southern California and the University of Southern California, Los Angeles, analyzed data from over 15,000 infants in southern California enrolled in WIC.
Records from infants born between Sept. 2012 and March 2016 were separated into two groups: infants that had stopped breastfeeding by month 3 and had started reduced-lactose formula and infants who received all other forms of formula. Over 80% of infants in both groups were Hispanic.
Infants who received the reduced-lactose formula with corn syrup solids were at an 8% increased risk of obesity by age 3 (RR = 1.08; 95% CI, 1.02, 1.15; P = .01), compared with children who received regular cow’s milk formula, and a 7% increased risk by age 4 (RR = 1.07; 95% CI; 1.01, 1.14; P = .01).
Tara Williams, MD, pediatrician and breastfeeding specialist associated with the Florida Chapter of American Academy of Pediatrics, said the findings should make pediatricians, parents, and others pause and consider what infant formulas contain.
She explained that babies who receive formula have higher obesity risk than babies who are breastfed overall. But research into the effects of different types of formula is relatively new. She said there may be a few reasons for the association between reduced-lactose, corn syrup solid formula and a higher risk of obesity.
“The addition of the corn syrup really starts to potentially teach that child to like sweet things,” Dr. Williams said, which in turn can lead to less healthy eating habits in childhood and adulthood.
Or, it may be that parents who tend to give their children lactose-reduced formula are less likely to be tolerant of fussy babies and end up feeding their babies more, Dr. Williams hypothesized.
In addition, emerging research shows corn syrup may act differently from other sugars in the gut microbiome and as it is metabolized in the liver, leading to weight gain.
Although parents make individual choices for what kind of formula to feed their infants, states play a large role in these choices. In 2018, 45% of babies in the United States were eligible for WIC, which is funded through the federal government but administered by states. State WIC programs request bids from formula manufacturers, and products chosen are then redeemed at retailers by parents.
“Now that we’re starting to see a signal that perhaps some formulas will have a potentially added risk of obesity for participants, states may say that when we’re helping mothers select among the formulas, we need to be very explicit about this additional risk,” said Christopher Anderson, PhD, MSPH, associate research scientist at the southern California Public Health Foundation Enterprises WIC and lead author of the study.
Dr. Williams said more research to do similar analyses in other populations is needed to draw cause and effect conclusions, while Dr. Corkins said he’d like to see more research into the amount of formula eaten and health connections to types of formula.
“We know as soon as you sign up for a baby registry at Target, you’re getting formula samples in the mail. You’re very aggressively marketed to; it’s a $55 billion industry,” Dr. Williams said. “And their goal is to sell their product – not to promote the health of infants. “This research certainly will cause us to pause and consider what we are feeding our infants in the United States and how we allow companies to market their products.”
Dr. Goran receives book royalties from Penguin Random House and is a scientific consultant for Yumi Foods and Else Nutrition. All other authors disclosed no conflicts of interest. Dr. Corkins reports working at a clinic that’s the site of a Takeda pharmaceutical research study. Dr. Williams reports no relevant financial relationships.
FROM AMERICAN JOURNAL OF CLINICAL NUTRITION
WIC review finds broad benefits, knowledge gaps
How exactly the national program achieves these outcomes, however, remains unclear, and study quality shows room for improvement, reported co–lead authors Maya Venkataramani, MD, MPH and S. Michelle Ogunwole, MD, PhD of Johns Hopkins University, Baltimore, and colleagues.
The WIC program, which has been serving low-income women and young children since 1974, “provides supplemental foods, nutrition education and breastfeeding support, screening and referrals to medical and social services, and support for high-risk pregnancies,” the investigators wrote in Annals of Internal Medicine. The U.S. Food and Nutrition Service administers the program.
The authors conducted a systematic review of 20 observational studies aimed at determining the impacts of WIC participation on maternal, neonatal-birth, and infant-child health outcomes.
All studies included in the review began in or after 2009, when the WIC food package was revised to better address diet-related chronic diseases. For inclusion in the review, studies were required to have a WIC-eligible comparison group. Included research also evaluated the relationship between WIC participation and the prespecified health outcomes.
“We found only 20 studies that fulfilled our rigorous study inclusion criteria for these specific outcomes,” the investigators wrote. “In some areas, the evidence was absent, and in others, the strength of evidence (SOE) was moderate or low.”
Six outcome categories were assessed: maternal morbidity, maternal pregnancy outcomes, maternal health behaviors, maternal health care utilization, child morbidity, and childhood health care utilization. Of these, maternal health care utilization had the most robust body of evidence, while data from studies evaluating maternal morbidity and child morbidity were deemed insufficient.
Based on eligible studies, WIC participation was associated with reduced risks of insufficient weight gain in pregnancy, preterm birth, low infant birthweight, and infant mortality. Participation was also associated with an increased likelihood of infant and child health care utilization, such as routine immunizations.
Growing evidence should drive enrollment
“Growing evidence points to WIC as a way to reduce risk of preterm birth and other adverse outcomes,” said Laura Jelliffe-Pawlowski, PhD, MS, professor at the University of California, San Francisco and a director for the UCSF California Preterm Birth Initiative.
Dr. Jelliffe-Pawlowski, who conducted a California-based study included in the paper, said the review is noteworthy because it shows that WIC-associated benefits are observed across locations.
“It’s not just in California; it’s across the country,” she said. “It’s a national call to action – where there’s partnership between national-, state- and community-level WIC programs – to make WIC as accessible as possible, and reflect community wants and needs, so that more people enroll, and more people stay enrolled.”
Dr. Jelliffe-Pawlowski’s coauthor on the California study, Rita Hamad, MD, PhD, associate professor of family & community medicine at UCSF and associate director of the UCSF Center for Health Equity, encouraged health care providers to drive WIC enrollment, noting that, presently, only one in four eligible 4-year-olds participates.
“Physicians and other health care stakeholders can help patients benefit from this program by encouraging them to sign up, and even by providing sign-up support in the form of a social worker or other staff member,” Dr. Hamad said. “There is also literature on the types of interventions that improve take-up of safety net programs that providers can look to.”
Goals of future research
Optimizing WIC operations, however, is only half the battle, considering the evidence gaps revealed by the review.
“We still need stronger studies that use more rigorous study designs ... to provide more convincing evidence to policymakers, as well as more evidence on long-term impacts,” Dr. Hamad said. “We also need to better understand why take-up is low in these programs despite these potential health benefits. Then we can make sure that economically disadvantaged families receive the benefits for which they are eligible through interventions to improve participation rates.”
Ideally, WIC programs would receive additional funding for independent parties to evaluate health outcomes, according to Ashwini Lakshmanan, MD, MS, MPH, associate professor in the department of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif.
Dr. Lakshmanan, who previously evaluated the benefits of WIC participation for high-risk infants, noted that randomized clinical trials would be unethical in this setting, yet data collection can still be “very conscientious and intentional,” with a focus on policy-shaping outcome metrics like immunizations and pediatric health care visits.
“The main point is thinking about it at the forefront, and not retrospectively,” Dr. Lakshmanan said.
Dr. Ogunwole, who led the present review, suggested in a written comment that future studies “could employ robust statistical methods (propensity matching, fixed effects models, etc.) to help reduce bias.”
She also recommended evaluating innovations in WIC programs; for example, adding a health coach, or conducting a cooking skills intervention.
Studies are also needed to better understand the various obstacles to WIC success, such as misconceptions about the program, discrimination, and barriers to enrollment, Dr. Ogunwole added.
“WIC enrollment has been decreasing for a number of years, and this was occurring prepandemic as well,” she said. “More work needs to be done to understand this issue.”
The study was supported by the Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services. The investigators and interviewees disclosed no conflicts of interest.
How exactly the national program achieves these outcomes, however, remains unclear, and study quality shows room for improvement, reported co–lead authors Maya Venkataramani, MD, MPH and S. Michelle Ogunwole, MD, PhD of Johns Hopkins University, Baltimore, and colleagues.
The WIC program, which has been serving low-income women and young children since 1974, “provides supplemental foods, nutrition education and breastfeeding support, screening and referrals to medical and social services, and support for high-risk pregnancies,” the investigators wrote in Annals of Internal Medicine. The U.S. Food and Nutrition Service administers the program.
The authors conducted a systematic review of 20 observational studies aimed at determining the impacts of WIC participation on maternal, neonatal-birth, and infant-child health outcomes.
All studies included in the review began in or after 2009, when the WIC food package was revised to better address diet-related chronic diseases. For inclusion in the review, studies were required to have a WIC-eligible comparison group. Included research also evaluated the relationship between WIC participation and the prespecified health outcomes.
“We found only 20 studies that fulfilled our rigorous study inclusion criteria for these specific outcomes,” the investigators wrote. “In some areas, the evidence was absent, and in others, the strength of evidence (SOE) was moderate or low.”
Six outcome categories were assessed: maternal morbidity, maternal pregnancy outcomes, maternal health behaviors, maternal health care utilization, child morbidity, and childhood health care utilization. Of these, maternal health care utilization had the most robust body of evidence, while data from studies evaluating maternal morbidity and child morbidity were deemed insufficient.
Based on eligible studies, WIC participation was associated with reduced risks of insufficient weight gain in pregnancy, preterm birth, low infant birthweight, and infant mortality. Participation was also associated with an increased likelihood of infant and child health care utilization, such as routine immunizations.
Growing evidence should drive enrollment
“Growing evidence points to WIC as a way to reduce risk of preterm birth and other adverse outcomes,” said Laura Jelliffe-Pawlowski, PhD, MS, professor at the University of California, San Francisco and a director for the UCSF California Preterm Birth Initiative.
Dr. Jelliffe-Pawlowski, who conducted a California-based study included in the paper, said the review is noteworthy because it shows that WIC-associated benefits are observed across locations.
“It’s not just in California; it’s across the country,” she said. “It’s a national call to action – where there’s partnership between national-, state- and community-level WIC programs – to make WIC as accessible as possible, and reflect community wants and needs, so that more people enroll, and more people stay enrolled.”
Dr. Jelliffe-Pawlowski’s coauthor on the California study, Rita Hamad, MD, PhD, associate professor of family & community medicine at UCSF and associate director of the UCSF Center for Health Equity, encouraged health care providers to drive WIC enrollment, noting that, presently, only one in four eligible 4-year-olds participates.
“Physicians and other health care stakeholders can help patients benefit from this program by encouraging them to sign up, and even by providing sign-up support in the form of a social worker or other staff member,” Dr. Hamad said. “There is also literature on the types of interventions that improve take-up of safety net programs that providers can look to.”
Goals of future research
Optimizing WIC operations, however, is only half the battle, considering the evidence gaps revealed by the review.
“We still need stronger studies that use more rigorous study designs ... to provide more convincing evidence to policymakers, as well as more evidence on long-term impacts,” Dr. Hamad said. “We also need to better understand why take-up is low in these programs despite these potential health benefits. Then we can make sure that economically disadvantaged families receive the benefits for which they are eligible through interventions to improve participation rates.”
Ideally, WIC programs would receive additional funding for independent parties to evaluate health outcomes, according to Ashwini Lakshmanan, MD, MS, MPH, associate professor in the department of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif.
Dr. Lakshmanan, who previously evaluated the benefits of WIC participation for high-risk infants, noted that randomized clinical trials would be unethical in this setting, yet data collection can still be “very conscientious and intentional,” with a focus on policy-shaping outcome metrics like immunizations and pediatric health care visits.
“The main point is thinking about it at the forefront, and not retrospectively,” Dr. Lakshmanan said.
Dr. Ogunwole, who led the present review, suggested in a written comment that future studies “could employ robust statistical methods (propensity matching, fixed effects models, etc.) to help reduce bias.”
She also recommended evaluating innovations in WIC programs; for example, adding a health coach, or conducting a cooking skills intervention.
Studies are also needed to better understand the various obstacles to WIC success, such as misconceptions about the program, discrimination, and barriers to enrollment, Dr. Ogunwole added.
“WIC enrollment has been decreasing for a number of years, and this was occurring prepandemic as well,” she said. “More work needs to be done to understand this issue.”
The study was supported by the Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services. The investigators and interviewees disclosed no conflicts of interest.
How exactly the national program achieves these outcomes, however, remains unclear, and study quality shows room for improvement, reported co–lead authors Maya Venkataramani, MD, MPH and S. Michelle Ogunwole, MD, PhD of Johns Hopkins University, Baltimore, and colleagues.
The WIC program, which has been serving low-income women and young children since 1974, “provides supplemental foods, nutrition education and breastfeeding support, screening and referrals to medical and social services, and support for high-risk pregnancies,” the investigators wrote in Annals of Internal Medicine. The U.S. Food and Nutrition Service administers the program.
The authors conducted a systematic review of 20 observational studies aimed at determining the impacts of WIC participation on maternal, neonatal-birth, and infant-child health outcomes.
All studies included in the review began in or after 2009, when the WIC food package was revised to better address diet-related chronic diseases. For inclusion in the review, studies were required to have a WIC-eligible comparison group. Included research also evaluated the relationship between WIC participation and the prespecified health outcomes.
“We found only 20 studies that fulfilled our rigorous study inclusion criteria for these specific outcomes,” the investigators wrote. “In some areas, the evidence was absent, and in others, the strength of evidence (SOE) was moderate or low.”
Six outcome categories were assessed: maternal morbidity, maternal pregnancy outcomes, maternal health behaviors, maternal health care utilization, child morbidity, and childhood health care utilization. Of these, maternal health care utilization had the most robust body of evidence, while data from studies evaluating maternal morbidity and child morbidity were deemed insufficient.
Based on eligible studies, WIC participation was associated with reduced risks of insufficient weight gain in pregnancy, preterm birth, low infant birthweight, and infant mortality. Participation was also associated with an increased likelihood of infant and child health care utilization, such as routine immunizations.
Growing evidence should drive enrollment
“Growing evidence points to WIC as a way to reduce risk of preterm birth and other adverse outcomes,” said Laura Jelliffe-Pawlowski, PhD, MS, professor at the University of California, San Francisco and a director for the UCSF California Preterm Birth Initiative.
Dr. Jelliffe-Pawlowski, who conducted a California-based study included in the paper, said the review is noteworthy because it shows that WIC-associated benefits are observed across locations.
“It’s not just in California; it’s across the country,” she said. “It’s a national call to action – where there’s partnership between national-, state- and community-level WIC programs – to make WIC as accessible as possible, and reflect community wants and needs, so that more people enroll, and more people stay enrolled.”
Dr. Jelliffe-Pawlowski’s coauthor on the California study, Rita Hamad, MD, PhD, associate professor of family & community medicine at UCSF and associate director of the UCSF Center for Health Equity, encouraged health care providers to drive WIC enrollment, noting that, presently, only one in four eligible 4-year-olds participates.
“Physicians and other health care stakeholders can help patients benefit from this program by encouraging them to sign up, and even by providing sign-up support in the form of a social worker or other staff member,” Dr. Hamad said. “There is also literature on the types of interventions that improve take-up of safety net programs that providers can look to.”
Goals of future research
Optimizing WIC operations, however, is only half the battle, considering the evidence gaps revealed by the review.
“We still need stronger studies that use more rigorous study designs ... to provide more convincing evidence to policymakers, as well as more evidence on long-term impacts,” Dr. Hamad said. “We also need to better understand why take-up is low in these programs despite these potential health benefits. Then we can make sure that economically disadvantaged families receive the benefits for which they are eligible through interventions to improve participation rates.”
Ideally, WIC programs would receive additional funding for independent parties to evaluate health outcomes, according to Ashwini Lakshmanan, MD, MS, MPH, associate professor in the department of health systems science at Kaiser Permanente Bernard J. Tyson School of Medicine, Pasadena, Calif.
Dr. Lakshmanan, who previously evaluated the benefits of WIC participation for high-risk infants, noted that randomized clinical trials would be unethical in this setting, yet data collection can still be “very conscientious and intentional,” with a focus on policy-shaping outcome metrics like immunizations and pediatric health care visits.
“The main point is thinking about it at the forefront, and not retrospectively,” Dr. Lakshmanan said.
Dr. Ogunwole, who led the present review, suggested in a written comment that future studies “could employ robust statistical methods (propensity matching, fixed effects models, etc.) to help reduce bias.”
She also recommended evaluating innovations in WIC programs; for example, adding a health coach, or conducting a cooking skills intervention.
Studies are also needed to better understand the various obstacles to WIC success, such as misconceptions about the program, discrimination, and barriers to enrollment, Dr. Ogunwole added.
“WIC enrollment has been decreasing for a number of years, and this was occurring prepandemic as well,” she said. “More work needs to be done to understand this issue.”
The study was supported by the Agency for Healthcare Research and Quality, U.S. Department of Health & Human Services. The investigators and interviewees disclosed no conflicts of interest.
FROM ANNALS OF INTERNAL MEDICINE
Robots better than humans at detecting mental well-being issues in children
Robots can be better at detecting mental well-being issues in children than parent-reported or self-reported testing, say U.K. researchers.
The researchers behind a new study, presented at the 31st IEEE International Conference on Robot & Human Interactive Communication (RO-MAN) in Naples, Italy, have suggested that robots could be a useful addition to traditional methods of mental health assessment.
“There are times when traditional methods aren’t able to catch mental well-being lapses in children, as sometimes the changes are incredibly subtle,” said Nida Itrat Abbasi, a PhD student at Cambridge (England) Affective Computing and Robotics Group, University of Cambridge, and the study’s first author. “We wanted to see whether robots might be able to help with this process,” she explained.
The authors highlighted how, during the COVID-19 pandemic, home schooling, financial pressures, and isolation from peers and friends impacted the mental health of many children. Even before the pandemic however, anxiety and depression among children in the United Kingdom has been on the rise, but the resources and support to address mental well-being are severely limited.
Children engage with robots
For their study the research team – which comprised roboticists, computer scientists, and psychiatrists from the University of Cambridge – enrolled 28 participants between ages 8 and 13 years. While being observed from an adjacent room by a parent or guardian, along with members of the research team, the participants took part in a one-to-one 45-minute session with a Nao robot – a humanoid robot about 60 cm tall – that administered a series of standard psychological questionnaires to assess the mental well-being of each participant.
Participants interacted with the robot throughout the session by speaking with it or by touching sensors on the robot’s hands and feet. Additional sensors tracked participants’ heartbeat, head, and eye movements during the session.
Professor Hatice Gunes, affective intelligence and robotics laboratory, department of computer science, University of Cambridge, said: “Children are quite tactile, and they’re drawn to technology. If they’re using a screen-based tool, they’re withdrawn from the physical world,” she said. “But robots are perfect because they’re in the physical world – they’re more interactive, so the children are more engaged.”
Prior to each session the children and their parent or guardian completed standard online questionnaires to assess each child’s mental well-being.
During each session, the robot performed four different tasks:
- Asked open-ended questions about happy and sad memories over the last week.
- Administered the Short Mood and Feelings Questionnaire (SMFQ).
- Administered a picture task inspired by the Children’s Apperception Test (CAT), where children are asked to answer questions related to pictures shown.
- Administered the Revised Children’s Anxiety and Depression Scale (RCADS) for generalized anxiety, panic disorder, and low mood.
Following the SMFQ children were divided into three different groups according to how likely they were to be struggling with their mental well-being.
The researchers found that children with varying levels of well-being concerns interacted differently with the robot. For children that might not be experiencing mental well-being–related problems, the researchers found that interacting with the robot led to more positive response ratings to the questionnaires. However, for children that might be experiencing well-being–related concerns, the robot may have enabled them to divulge their true feelings and experiences, leading to more negative response ratings to the questionnaire.
Robots an addition not a replacement
“Since the robot we use is child-sized, and completely nonthreatening, children might see the robot as a confidant – they feel like they won’t get into trouble if they share secrets with it,” said Ms. Abbasi. “Other researchers have found that children are more likely to divulge private information – like that they’re being bullied, for example – to a robot than they would be to an adult,” she said.
Study participants all said they “enjoyed talking with the robot,” commented the authors, who added that, “the children were willing to confide in the robot, in some cases sharing information with the robot that they had not yet shared via the standard assessment method of online or in-person questionnaires.”
This is the first time that robots have been used to assess mental well-being in children, the researchers pointed out. “Robots could be a useful addition to traditional methods of mental health assessment,” they said, though they emphasized that robots are “not intended to be a substitute for professional mental health support.”
“We don’t have any intention of replacing psychologists or other mental health professionals with robots, since their expertise far surpasses anything a robot can do,” said Dr. Micol Spitale, affective computing and robotics laboratory, University of Cambridge, and study coauthor. “However, our work suggests that robots could be a useful tool in helping children to open up and share things they might not be comfortable sharing at first.”
The researchers say that they hope to expand their survey in future by including more participants and following them over time. They are also investigating whether similar results could be achieved if children interact with the robot via video chat.
A version of this article first appeared on Medscape UK.
Robots can be better at detecting mental well-being issues in children than parent-reported or self-reported testing, say U.K. researchers.
The researchers behind a new study, presented at the 31st IEEE International Conference on Robot & Human Interactive Communication (RO-MAN) in Naples, Italy, have suggested that robots could be a useful addition to traditional methods of mental health assessment.
“There are times when traditional methods aren’t able to catch mental well-being lapses in children, as sometimes the changes are incredibly subtle,” said Nida Itrat Abbasi, a PhD student at Cambridge (England) Affective Computing and Robotics Group, University of Cambridge, and the study’s first author. “We wanted to see whether robots might be able to help with this process,” she explained.
The authors highlighted how, during the COVID-19 pandemic, home schooling, financial pressures, and isolation from peers and friends impacted the mental health of many children. Even before the pandemic however, anxiety and depression among children in the United Kingdom has been on the rise, but the resources and support to address mental well-being are severely limited.
Children engage with robots
For their study the research team – which comprised roboticists, computer scientists, and psychiatrists from the University of Cambridge – enrolled 28 participants between ages 8 and 13 years. While being observed from an adjacent room by a parent or guardian, along with members of the research team, the participants took part in a one-to-one 45-minute session with a Nao robot – a humanoid robot about 60 cm tall – that administered a series of standard psychological questionnaires to assess the mental well-being of each participant.
Participants interacted with the robot throughout the session by speaking with it or by touching sensors on the robot’s hands and feet. Additional sensors tracked participants’ heartbeat, head, and eye movements during the session.
Professor Hatice Gunes, affective intelligence and robotics laboratory, department of computer science, University of Cambridge, said: “Children are quite tactile, and they’re drawn to technology. If they’re using a screen-based tool, they’re withdrawn from the physical world,” she said. “But robots are perfect because they’re in the physical world – they’re more interactive, so the children are more engaged.”
Prior to each session the children and their parent or guardian completed standard online questionnaires to assess each child’s mental well-being.
During each session, the robot performed four different tasks:
- Asked open-ended questions about happy and sad memories over the last week.
- Administered the Short Mood and Feelings Questionnaire (SMFQ).
- Administered a picture task inspired by the Children’s Apperception Test (CAT), where children are asked to answer questions related to pictures shown.
- Administered the Revised Children’s Anxiety and Depression Scale (RCADS) for generalized anxiety, panic disorder, and low mood.
Following the SMFQ children were divided into three different groups according to how likely they were to be struggling with their mental well-being.
The researchers found that children with varying levels of well-being concerns interacted differently with the robot. For children that might not be experiencing mental well-being–related problems, the researchers found that interacting with the robot led to more positive response ratings to the questionnaires. However, for children that might be experiencing well-being–related concerns, the robot may have enabled them to divulge their true feelings and experiences, leading to more negative response ratings to the questionnaire.
Robots an addition not a replacement
“Since the robot we use is child-sized, and completely nonthreatening, children might see the robot as a confidant – they feel like they won’t get into trouble if they share secrets with it,” said Ms. Abbasi. “Other researchers have found that children are more likely to divulge private information – like that they’re being bullied, for example – to a robot than they would be to an adult,” she said.
Study participants all said they “enjoyed talking with the robot,” commented the authors, who added that, “the children were willing to confide in the robot, in some cases sharing information with the robot that they had not yet shared via the standard assessment method of online or in-person questionnaires.”
This is the first time that robots have been used to assess mental well-being in children, the researchers pointed out. “Robots could be a useful addition to traditional methods of mental health assessment,” they said, though they emphasized that robots are “not intended to be a substitute for professional mental health support.”
“We don’t have any intention of replacing psychologists or other mental health professionals with robots, since their expertise far surpasses anything a robot can do,” said Dr. Micol Spitale, affective computing and robotics laboratory, University of Cambridge, and study coauthor. “However, our work suggests that robots could be a useful tool in helping children to open up and share things they might not be comfortable sharing at first.”
The researchers say that they hope to expand their survey in future by including more participants and following them over time. They are also investigating whether similar results could be achieved if children interact with the robot via video chat.
A version of this article first appeared on Medscape UK.
Robots can be better at detecting mental well-being issues in children than parent-reported or self-reported testing, say U.K. researchers.
The researchers behind a new study, presented at the 31st IEEE International Conference on Robot & Human Interactive Communication (RO-MAN) in Naples, Italy, have suggested that robots could be a useful addition to traditional methods of mental health assessment.
“There are times when traditional methods aren’t able to catch mental well-being lapses in children, as sometimes the changes are incredibly subtle,” said Nida Itrat Abbasi, a PhD student at Cambridge (England) Affective Computing and Robotics Group, University of Cambridge, and the study’s first author. “We wanted to see whether robots might be able to help with this process,” she explained.
The authors highlighted how, during the COVID-19 pandemic, home schooling, financial pressures, and isolation from peers and friends impacted the mental health of many children. Even before the pandemic however, anxiety and depression among children in the United Kingdom has been on the rise, but the resources and support to address mental well-being are severely limited.
Children engage with robots
For their study the research team – which comprised roboticists, computer scientists, and psychiatrists from the University of Cambridge – enrolled 28 participants between ages 8 and 13 years. While being observed from an adjacent room by a parent or guardian, along with members of the research team, the participants took part in a one-to-one 45-minute session with a Nao robot – a humanoid robot about 60 cm tall – that administered a series of standard psychological questionnaires to assess the mental well-being of each participant.
Participants interacted with the robot throughout the session by speaking with it or by touching sensors on the robot’s hands and feet. Additional sensors tracked participants’ heartbeat, head, and eye movements during the session.
Professor Hatice Gunes, affective intelligence and robotics laboratory, department of computer science, University of Cambridge, said: “Children are quite tactile, and they’re drawn to technology. If they’re using a screen-based tool, they’re withdrawn from the physical world,” she said. “But robots are perfect because they’re in the physical world – they’re more interactive, so the children are more engaged.”
Prior to each session the children and their parent or guardian completed standard online questionnaires to assess each child’s mental well-being.
During each session, the robot performed four different tasks:
- Asked open-ended questions about happy and sad memories over the last week.
- Administered the Short Mood and Feelings Questionnaire (SMFQ).
- Administered a picture task inspired by the Children’s Apperception Test (CAT), where children are asked to answer questions related to pictures shown.
- Administered the Revised Children’s Anxiety and Depression Scale (RCADS) for generalized anxiety, panic disorder, and low mood.
Following the SMFQ children were divided into three different groups according to how likely they were to be struggling with their mental well-being.
The researchers found that children with varying levels of well-being concerns interacted differently with the robot. For children that might not be experiencing mental well-being–related problems, the researchers found that interacting with the robot led to more positive response ratings to the questionnaires. However, for children that might be experiencing well-being–related concerns, the robot may have enabled them to divulge their true feelings and experiences, leading to more negative response ratings to the questionnaire.
Robots an addition not a replacement
“Since the robot we use is child-sized, and completely nonthreatening, children might see the robot as a confidant – they feel like they won’t get into trouble if they share secrets with it,” said Ms. Abbasi. “Other researchers have found that children are more likely to divulge private information – like that they’re being bullied, for example – to a robot than they would be to an adult,” she said.
Study participants all said they “enjoyed talking with the robot,” commented the authors, who added that, “the children were willing to confide in the robot, in some cases sharing information with the robot that they had not yet shared via the standard assessment method of online or in-person questionnaires.”
This is the first time that robots have been used to assess mental well-being in children, the researchers pointed out. “Robots could be a useful addition to traditional methods of mental health assessment,” they said, though they emphasized that robots are “not intended to be a substitute for professional mental health support.”
“We don’t have any intention of replacing psychologists or other mental health professionals with robots, since their expertise far surpasses anything a robot can do,” said Dr. Micol Spitale, affective computing and robotics laboratory, University of Cambridge, and study coauthor. “However, our work suggests that robots could be a useful tool in helping children to open up and share things they might not be comfortable sharing at first.”
The researchers say that they hope to expand their survey in future by including more participants and following them over time. They are also investigating whether similar results could be achieved if children interact with the robot via video chat.
A version of this article first appeared on Medscape UK.
Dolutegravir in pregnant patients with HIV showed more viral suppression at delivery vs. other treatments
“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.
In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.
The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.
The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.
The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.
“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.
Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.
A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.
“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.
“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.
The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.
However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
Findings fill a key research gap
The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.
Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.
The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.
The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”
Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.
The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.
The researchers and Dr. Badell had no financial conflicts to disclose.
“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.
In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.
The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.
The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.
The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.
“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.
Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.
A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.
“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.
“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.
The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.
However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
Findings fill a key research gap
The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.
Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.
The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.
The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”
Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.
The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.
The researchers and Dr. Badell had no financial conflicts to disclose.
“Dolutegravir is increasingly used in pregnancy in the United States,” Kunjal Patel, DSc, one of the investigators, said in an interview. “While its effectiveness and safety in pregnancy have been compared to efavirenz in previous studies, including three randomized trials, efavirenz isn’t really used in the United States and Europe for treatment of HIV; it is mainly used in Africa,” she said. Therefore, it was important to compare dolutegravir use in pregnancy to the other antiretroviral regimens that are listed as being preferred for use in pregnancy in the U.S., including atazanavir/ritonavir, darunavir/ritonavir, and raltegravir, and others often used in the U.S. and Europe, she said.
In the study published in the New England Journal of Medicine, Dr. Patel, of Harvard T.H. Chan School of Public Health, Boston, and colleagues analyzed data from kids enrolled in the Surveillance and Monitoring for ART Toxicities Dynamic (SMARTT) cohort. This group is part of an ongoing research project focused on evaluating ART toxicities during pregnancy in children who were exposed to HIV perinatally but not infected. It included pregnancies from 2007 until January 2020 that involved use of the ARTs listed.
The study population of 1,257 pregnancies with observed birth outcomes included 120 individuals with an initial ART of dolutegravir (DTG), 464 started on atazanavir–ritonavir (ATV/r), 185 on darunavir–ritonavir (DRV/r), 243 on oral rilpivirine (RPV), 86 on raltegravir (RAL), and 159 on elvitegravir–cobicistat (EVG/c). In approximately half of the pregnancies (51%), ART was started before conception, and the initial ART was changed in 27%.
The primary outcomes were viral suppression at delivery, and adverse birth outcomes, including preterm and very preterm birth, low and very low birth weight, and neonatal death within 14 days.
The median age of the patients at conception was 29 years, and 66% were non-Hispanic Black, representative of persons with HIV of childbearing age in the United States, the researchers noted. Overall, 96.7% of the patients who received dolutegravir showed viral suppression at delivery, compared to 90.1% for darunavir–ritonavir, 89.8% for elvitegravir–cobicistat, 89.2% for raltegravir, and 84.0% for atazanavir–ritonavir.
“We expected that dolutegravir to be similar with regards to viral suppression at delivery compared to raltegravir so were surprised that we observed less viral suppression with raltegravir compared to dolutegravir,” Dr. Patel said in an interview. “Our results may be due to the higher pill burden and lower barrier to resistance with RAL compared to dolutegravir, but we did not assess adherence or resistance in our study,” she noted.
Across ART regimens, the observed risks of preterm birth ranged from 13.6% to 17.6%, risks of low birth weight ranged from 11.9% to 16.7%, and risks of being small for gestational age ranged from 9.1% to 12.5%. For the composite of any adverse birth outcome and any severe adverse birth outcome, the observed risks ranged from 22.6% to 27.9% and 0% to 4.2%, respectively.
A total of 20 very preterm births, including 15 infants with very low birth weight, occurred across patients receiving all ART regimens, and no neonatal deaths occurred. The researchers found no apparent patterns of differences in the observed risk of adverse birth outcomes across all groups related to the timing of ART initiation in pregnancy, but the risks were greater among those who began the drugs during pregnancy compared to those who began before conception.
“Our results confirm the recommendation of DTG as “preferred” in U.S. perinatal guidelines, and provide evidence suggesting ATV/r and RAL provides lower HIV viral suppression at delivery compared to DTG, and support DRV/r as a reasonable alternative when DTG use is not feasible,” Dr. Patel said in an interview.
“With regards to next steps, we are interested in comparing the effectiveness and safety of dolutegravir-based regimens that include tenofovir alafenamide (TAF) vs. tenofovir disoproxil fumarate (TDF) in our U.S. setting,” she said.
The study findings were limited by several factors including the lack of data on predictors of preterm birth and low birth weight, such as previous preterm birth and prepregnancy body mass index, the researchers noted.
However, the results indicate that other common ARTs provide less HIV viral suppression at delivery than dolutegravir, with similar adverse birth outcomes; the results also support darunavir–ritonavir as a reasonable alternative when dolutegravir use is not feasible, as it showed the next highest level of viral suppression after dolutegravir, the researchers concluded.
Findings fill a key research gap
The current study is important given the limited data on effectiveness and outcomes in pregnancy with the use of contemporary HIV regimens in the United States, Martina L. Badell, MD, a maternal-fetal medicine specialist at Emory University, Atlanta, said in an interview.
“Pregnancy is still among exclusion criteria for most drug studies,” said Dr. Badell, who was not involved in the current study. “Dolutegravir-based ART is first line in the U.S. today because of its effectiveness, lower side effects, and higher barrier to resistance; therefore understanding the benefits and birth outcomes in pregnancy is critical,” she explained.
Dr. Badell said she was not surprised by the study findings. “However it is very reassuring to see in a large observational study comparing the dolutegravir regimens to other contemporary regimens in pregnancy, such a high level of viral suppression and no increased risk of adverse perinatal outcomes,” she said.
The study findings will impact clinical practice by reaffirming patient counseling regarding the use of dolutegravir in pregnancy, said Dr. Badell. “The use of ART in pregnancy is complex given the number of drug choices, whether the patient was on ART prior to pregnancy or initiated during pregnancy, and the various factors other than ART that affect perinatal outcomes, such as preterm birth and congenital anomalies, she explained.
The finding that the risk of adverse outcomes was higher for those who initiated ART during pregnancy vs. those who were already on ARTs when they became pregnant contradicts some previous research, said Dr. Badell. But this is “reassuring, as we highly recommend ART with viral suppression prior to pregnancy or to start as early as possible in pregnancy.”
Adverse birth outcomes can be affected by many variables such as age, substance abuse, prior adverse birth outcome and other factors, and larger studies that control for these variables will allow better evaluation of the effect of the ART drugs, Dr. Badell added.
The study was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, along with the Office of the Director, National Institutes of Health; National Institute of Dental and Craniofacial Research; National Institute of Allergy and Infectious Diseases; National Institute of Neurological Disorders and Stroke; National Institute on Deafness and Other Communication Disorders; National Institute of Mental Health; National Institute on Drug Abuse; National Cancer Institute; National Institute on Alcohol Abuse and Alcoholism; and National Heart, Lung, and Blood Institute through cooperative agreements with the Harvard T.H. Chan School of Public Health and the Tulane University School of Medicine.
The researchers and Dr. Badell had no financial conflicts to disclose.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
CDC gives final approval to Omicron COVID-19 vaccine boosters
The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.
The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.
The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation.
“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”
The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.
Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.
What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.
ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.
“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,” Dr. Sanchez said.
Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.
“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”
Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.
Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.
Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.
“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.
Earlier in the day, committee member Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.
“So after thinking about it, I am comfortable even though we don’t have human data,” he said.
There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.
The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.
But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.
“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.
The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD, chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.
“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.
A version of this article first appeared on WebMD.com.
The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.
The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.
The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation.
“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”
The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.
Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.
What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.
ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.
“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,” Dr. Sanchez said.
Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.
“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”
Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.
Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.
Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.
“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.
Earlier in the day, committee member Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.
“So after thinking about it, I am comfortable even though we don’t have human data,” he said.
There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.
The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.
But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.
“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.
The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD, chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.
“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.
A version of this article first appeared on WebMD.com.
The Centers for Disease Control and Prevention on Sept. 1 approved the use of vaccines designed to target both Omicron and the older variants of the coronavirus, a step that may aid a goal of a widespread immunization campaign before winter arrives in the United States.
The CDC’s Advisory Committee on Immunization Practices voted 13-1 on two separate questions. One sought the panel’s backing for the use of a single dose of a new version of the Pfizer COVID-19 vaccines for people aged 12 and older. The second question dealt with a single dose of the reworked Moderna vaccine for people aged 18 and older.
The federal government wants to speed use of revamped COVID-19 shots, which the Food and Drug Administration on Sept. 1 cleared for use in the United States. Hours later, CDC Director Rochelle Walensky, MD, agreed with the panel’s recommendation.
“The updated COVID-19 boosters are formulated to better protect against the most recently circulating COVID-19 variant,” Dr. Walensky said in a statement. “They can help restore protection that has waned since previous vaccination and were designed to provide broader protection against newer variants. This recommendation followed a comprehensive scientific evaluation and robust scientific discussion. If you are eligible, there is no bad time to get your COVID-19 booster and I strongly encourage you to receive it.”
The FDA vote on Aug. 31 expanded the emergency use authorization EUA for both Moderna and Pfizer’s original COVID-19 vaccines. The new products are also called “updated boosters.” Both contain two mRNA components of SARS-CoV-2 virus, one of the original strain and another that is found in the BA.4 and BA.5 strains of the Omicron variant, the FDA said.
Basically, the FDA cleared the way for these new boosters after it relied heavily on results of certain blood tests that suggested an immune response boost from the new formulas, plus 18 months of mostly safe use of the original versions of the shots.
What neither the FDA nor the CDC has, however, is evidence from studies in humans on how well these new vaccines work or whether they are as safe as the originals. But the FDA did consider clinical evidence for the older shots and results from studies on the new boosters that were done in mice.
ACIP Committee member Pablo Sanchez, MD, of Ohio State University was the sole “no” vote on each question.
“It’s a new vaccine, it’s a new platform. There’s a lot of hesitancy already. We need the human data,” Dr. Sanchez said.
Dr. Sanchez did not doubt that the newer versions of the vaccine would prove safe.
“I personally am in the age group where I’m at high risk and I’m almost sure that I will receive it,” Dr. Sanchez said. “I just feel that this was a bit premature, and I wish that we had seen that data. Having said that, I am comfortable that the vaccine will likely be safe like the others.”
Dr. Sanchez was not alone in raising concerns about backing new COVID-19 shots for which there is not direct clinical evidence from human studies.
Committee member Sarah Long, MD, of Drexel University in Philadelphia, said during the discussion she would “reluctantly” vote in favor of the updated vaccines. She said she believes they will have the potential to reduce hospitalizations and even deaths, even with questions remaining about the data.
Dr. Long joined other committee members in pointing to the approach to updating flu vaccines as a model. In an attempt to keep ahead of influenza, companies seek to defeat new strains through tweaks to their FDA-approved vaccines. There is not much clinical information available about these revised products, Dr. Long said. She compared it to remodeling an existing home.
“It is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” with the revisions to the flu vaccine, she said.
Earlier in the day, committee member Jamie Loehr, MD, of Cayuga Family Medicine in Ithaca, N.Y., also used changes to the annual flu shots as the model for advancing COVID-19 shots.
“So after thinking about it, I am comfortable even though we don’t have human data,” he said.
There were several questions during the meeting about why the FDA had not convened a meeting of its Vaccines and Related Biological Products Advisory Committee (regarding these specific bivalent vaccines). Typically, the FDA committee of advisers considers new vaccines before the agency authorizes their use. In this case, however, the agency acted on its own.
The FDA said the committee considered the new, bivalent COVID-19 boosters in earlier meetings and that was enough outside feedback.
But holding a meeting of advisers on these specific products could have helped build public confidence in these medicines, Dorit Reiss, PhD, of the University of California Hastings College of Law, said during the public comment session of the CDC advisers’ meeting.
“We could wish the vaccines were more effective against infection, but they’re safe and they prevent hospitalization and death,” she said.
The Department of Health and Human Services anticipated the backing of ACIP. The Administration for Strategic Preparedness and Response on Aug. 31 began distributing “millions of doses of the updated booster to tens of thousands of sites nationwide,” Jason Roos, PhD, chief operating officer for HHS Coordination Operations and Response Element, wrote in a blog.
“These boosters will be available at tens of thousands of vaccination sites ... including local pharmacies, their physicians’ offices, and vaccine centers operated by state and local health officials,”Dr. Roos wrote.
A version of this article first appeared on WebMD.com.