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Lions and tigers and anteaters? U.S. scientists scan the menagerie for COVID
As COVID-19 cases surge in the United States, one Texas veterinarian has been quietly tracking the spread of the disease – not in people, but in their pets.
Since June, Dr. Sarah Hamer and her team at Texas A&M University have tested hundreds of animals from area households where humans contracted COVID-19. They’ve swabbed dogs and cats, sure, but also pet hamsters and guinea pigs, looking for signs of infection. “We’re open to all of it,” said Dr. Hamer, a professor of epidemiology, who has found at least 19 cases of infection.
One pet that tested positive was Phoenix, a 7-year-old part Siamese cat owned by Kaitlyn Romoser, who works in a university lab. Ms. Romoser, 23, was confirmed to have COVID-19 twice, once in March and again in September. The second time she was much sicker, she said, and Phoenix was her constant companion.
“If I would have known animals were just getting it everywhere, I would have tried to distance myself, but he will not distance himself from me,” Ms. Romoser said. “He sleeps in my bed with me. There was absolutely no social distancing.”
Across the country, veterinarians and other researchers are scouring the animal kingdom for signs of the virus that causes COVID-19. At least 2,000 animals in the U.S. have been tested for the coronavirus since the pandemic began, according to federal records. Cats and dogs that were exposed to sick owners represent most of the animals tested and 80% of the positive cases found.
But scientists have cast a wide net investigating other animals that could be at risk. In states from California to Florida, researchers have tested species ranging from farmed minks and zoo cats to unexpected critters like dolphins, armadillos, and anteaters.
The U.S. Department of Agriculture keeps an official tally of confirmed animal COVID cases that stands at several dozen. But that list is a vast undercount of actual infections. In Utah and Wisconsin, for instance, more than 14,000 minks died in recent weeks after contracting COVID infections initially spread by humans.
So far, there’s limited evidence that animals are transmitting the virus to people. Veterinarians emphasize that pet owners appear to be in no danger from their animal companions and should continue to love and care for them. But scientists say continued testing is one way to remain vigilant in the face of a previously unknown pathogen.
“We just know that coronaviruses, as a family, infect a lot of species, mostly mammals,” said Dr. Peter Rabinowitz, a professor of environmental and occupational health sciences and the director of the University of Washington Center for One Health Research in Seattle. “It makes sense to take a species-spanning approach and look at a wide spectrum.”
Much of the testing has been rooted in scientific curiosity. Since the pandemic began, a major puzzle has been how the virus, which likely originated in bats, spread to humans. A leading theory is that it jumped to an intermediate species, still unknown, and then to people.
In April, a 4-year-old Malayan tiger at the Bronx Zoo tested positive for COVID-19 in a first-of-its-kind case after seven big cats showed signs of respiratory illness. The tiger, Nadia, contracted the virus from a caretaker, federal health officials said. Four other tigers and three African lions were also confirmed to be infected.
In Washington state, the site of the first U.S. outbreak in humans, scientists rushed to design a COVID test for animals in March, said Charlie Powell, a spokesperson for the Washington State University College of Veterinary Medicine, Pullman. “We knew with warm-blooded animals, housed together, there’s going to be some cross-infection,” he said. Tests for animals use different reagent compounds than those used for tests in people, so they don’t deplete the human supply, Mr. Powell added.
Since spring, the Washington Animal Disease Diagnostic Laboratory has tested nearly 80 animals, including 38 dogs, 29 cats, 2 ferrets, a camel, and 2 tamanduas, a type of anteater. The lab also tested six minks from the outbreak in Utah, five of which accounted for the lab’s only positive tests.
All told, nearly 1,400 animals have been tested for COVID-19 through the National Animal Health Laboratory Network or private labs, said Lyndsay Cole, a spokesperson for the USDA’s Animal and Plant Health Inspection Service. More than 400 animals have been tested through the National Veterinary Services Laboratories. At least 250 more have been tested through academic research projects.
Most of the tests have been in household cats and dogs with suspicious respiratory symptoms. In June, the USDA reported that a dog in New York was the first pet dog to test positive for the coronavirus after falling ill and struggling to breathe. The dog, a 7-year-old German shepherd named Buddy, later died. Officials determined he’d contracted the virus from his owner.
Neither the Centers for Disease Control and Prevention nor the USDA recommends routine testing for house pets or other animals – but that hasn’t stopped owners from asking, said Dr. Douglas Kratt, president of the American Veterinary Medical Association.
“The questions have become a little more consistent at my practice,” he said. “People do want to know about COVID-19 and their pets. Can their pet pick it up at a clinic or boarding or in doggie day care?”
The answer, so far, is that humans are the primary source of infection in pets. In September, a small, unpublished study from the University of Guelph in Canada found that companion cats and dogs appeared to be infected by their sick owners, judging by antibodies to the coronavirus detected in their blood.
In Texas, Dr. Hamer started testing animals from households where someone had contracted COVID-19 to learn more about transmission pathways. “Right now, we’re very much trying to describe what’s happening in nature,” she said.
So far, most of the animals – including Phoenix, Ms. Romoser’s cat – have shown no signs of illness or disease. That’s true so far for many species of animals tested for COVID-19, veterinarians said. Most nonhuman creatures appear to weather COVID infection with mild symptoms like sniffles and lethargy, if any.
Still, owners should apply best practices for avoiding COVID infection to pets, too, Dr. Kratt said. Don’t let pets come into contact with unfamiliar animals, he suggested. Owners should wash their hands frequently and avoid nuzzling and other very close contact, if possible.
Cats appear to be more susceptible to COVID-19 than dogs, researchers said. And minks, which are farmed in the U.S. and elsewhere for their fur, appear quite vulnerable.
In the meantime, the list of creatures tested for COVID-19 – whether for illness or science – is growing. In Florida, 22 animals had been tested as of early October, including 3 wild dolphins, 2 civets, 2 clouded leopards, a gorilla, an orangutan, an alpaca, and a bush baby, state officials said.
In California, 29 animals had been tested by the end of September, including a meerkat, a monkey, and a coatimundi, a member of the raccoon family.
In Seattle, a plan to test orcas, or killer whales, in Puget Sound was called off at the last minute after a member of the scientific team was exposed to COVID-19 and had to quarantine, said Dr. Joe Gaydos, a senior wildlife veterinarian and science director for the SeaDoc Society, a conservation program at the University of California-Davis. The group missed its September window to locate the animals and obtain breath and fecal samples for analysis.
No one thinks marine animals will play a big role in the pandemic decimating the human population, Dr. Gaydos said. But testing many creatures on both land and sea is vital.
“We don’t know what this virus is going to do or can do,” Dr. Gaydos said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
As COVID-19 cases surge in the United States, one Texas veterinarian has been quietly tracking the spread of the disease – not in people, but in their pets.
Since June, Dr. Sarah Hamer and her team at Texas A&M University have tested hundreds of animals from area households where humans contracted COVID-19. They’ve swabbed dogs and cats, sure, but also pet hamsters and guinea pigs, looking for signs of infection. “We’re open to all of it,” said Dr. Hamer, a professor of epidemiology, who has found at least 19 cases of infection.
One pet that tested positive was Phoenix, a 7-year-old part Siamese cat owned by Kaitlyn Romoser, who works in a university lab. Ms. Romoser, 23, was confirmed to have COVID-19 twice, once in March and again in September. The second time she was much sicker, she said, and Phoenix was her constant companion.
“If I would have known animals were just getting it everywhere, I would have tried to distance myself, but he will not distance himself from me,” Ms. Romoser said. “He sleeps in my bed with me. There was absolutely no social distancing.”
Across the country, veterinarians and other researchers are scouring the animal kingdom for signs of the virus that causes COVID-19. At least 2,000 animals in the U.S. have been tested for the coronavirus since the pandemic began, according to federal records. Cats and dogs that were exposed to sick owners represent most of the animals tested and 80% of the positive cases found.
But scientists have cast a wide net investigating other animals that could be at risk. In states from California to Florida, researchers have tested species ranging from farmed minks and zoo cats to unexpected critters like dolphins, armadillos, and anteaters.
The U.S. Department of Agriculture keeps an official tally of confirmed animal COVID cases that stands at several dozen. But that list is a vast undercount of actual infections. In Utah and Wisconsin, for instance, more than 14,000 minks died in recent weeks after contracting COVID infections initially spread by humans.
So far, there’s limited evidence that animals are transmitting the virus to people. Veterinarians emphasize that pet owners appear to be in no danger from their animal companions and should continue to love and care for them. But scientists say continued testing is one way to remain vigilant in the face of a previously unknown pathogen.
“We just know that coronaviruses, as a family, infect a lot of species, mostly mammals,” said Dr. Peter Rabinowitz, a professor of environmental and occupational health sciences and the director of the University of Washington Center for One Health Research in Seattle. “It makes sense to take a species-spanning approach and look at a wide spectrum.”
Much of the testing has been rooted in scientific curiosity. Since the pandemic began, a major puzzle has been how the virus, which likely originated in bats, spread to humans. A leading theory is that it jumped to an intermediate species, still unknown, and then to people.
In April, a 4-year-old Malayan tiger at the Bronx Zoo tested positive for COVID-19 in a first-of-its-kind case after seven big cats showed signs of respiratory illness. The tiger, Nadia, contracted the virus from a caretaker, federal health officials said. Four other tigers and three African lions were also confirmed to be infected.
In Washington state, the site of the first U.S. outbreak in humans, scientists rushed to design a COVID test for animals in March, said Charlie Powell, a spokesperson for the Washington State University College of Veterinary Medicine, Pullman. “We knew with warm-blooded animals, housed together, there’s going to be some cross-infection,” he said. Tests for animals use different reagent compounds than those used for tests in people, so they don’t deplete the human supply, Mr. Powell added.
Since spring, the Washington Animal Disease Diagnostic Laboratory has tested nearly 80 animals, including 38 dogs, 29 cats, 2 ferrets, a camel, and 2 tamanduas, a type of anteater. The lab also tested six minks from the outbreak in Utah, five of which accounted for the lab’s only positive tests.
All told, nearly 1,400 animals have been tested for COVID-19 through the National Animal Health Laboratory Network or private labs, said Lyndsay Cole, a spokesperson for the USDA’s Animal and Plant Health Inspection Service. More than 400 animals have been tested through the National Veterinary Services Laboratories. At least 250 more have been tested through academic research projects.
Most of the tests have been in household cats and dogs with suspicious respiratory symptoms. In June, the USDA reported that a dog in New York was the first pet dog to test positive for the coronavirus after falling ill and struggling to breathe. The dog, a 7-year-old German shepherd named Buddy, later died. Officials determined he’d contracted the virus from his owner.
Neither the Centers for Disease Control and Prevention nor the USDA recommends routine testing for house pets or other animals – but that hasn’t stopped owners from asking, said Dr. Douglas Kratt, president of the American Veterinary Medical Association.
“The questions have become a little more consistent at my practice,” he said. “People do want to know about COVID-19 and their pets. Can their pet pick it up at a clinic or boarding or in doggie day care?”
The answer, so far, is that humans are the primary source of infection in pets. In September, a small, unpublished study from the University of Guelph in Canada found that companion cats and dogs appeared to be infected by their sick owners, judging by antibodies to the coronavirus detected in their blood.
In Texas, Dr. Hamer started testing animals from households where someone had contracted COVID-19 to learn more about transmission pathways. “Right now, we’re very much trying to describe what’s happening in nature,” she said.
So far, most of the animals – including Phoenix, Ms. Romoser’s cat – have shown no signs of illness or disease. That’s true so far for many species of animals tested for COVID-19, veterinarians said. Most nonhuman creatures appear to weather COVID infection with mild symptoms like sniffles and lethargy, if any.
Still, owners should apply best practices for avoiding COVID infection to pets, too, Dr. Kratt said. Don’t let pets come into contact with unfamiliar animals, he suggested. Owners should wash their hands frequently and avoid nuzzling and other very close contact, if possible.
Cats appear to be more susceptible to COVID-19 than dogs, researchers said. And minks, which are farmed in the U.S. and elsewhere for their fur, appear quite vulnerable.
In the meantime, the list of creatures tested for COVID-19 – whether for illness or science – is growing. In Florida, 22 animals had been tested as of early October, including 3 wild dolphins, 2 civets, 2 clouded leopards, a gorilla, an orangutan, an alpaca, and a bush baby, state officials said.
In California, 29 animals had been tested by the end of September, including a meerkat, a monkey, and a coatimundi, a member of the raccoon family.
In Seattle, a plan to test orcas, or killer whales, in Puget Sound was called off at the last minute after a member of the scientific team was exposed to COVID-19 and had to quarantine, said Dr. Joe Gaydos, a senior wildlife veterinarian and science director for the SeaDoc Society, a conservation program at the University of California-Davis. The group missed its September window to locate the animals and obtain breath and fecal samples for analysis.
No one thinks marine animals will play a big role in the pandemic decimating the human population, Dr. Gaydos said. But testing many creatures on both land and sea is vital.
“We don’t know what this virus is going to do or can do,” Dr. Gaydos said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
As COVID-19 cases surge in the United States, one Texas veterinarian has been quietly tracking the spread of the disease – not in people, but in their pets.
Since June, Dr. Sarah Hamer and her team at Texas A&M University have tested hundreds of animals from area households where humans contracted COVID-19. They’ve swabbed dogs and cats, sure, but also pet hamsters and guinea pigs, looking for signs of infection. “We’re open to all of it,” said Dr. Hamer, a professor of epidemiology, who has found at least 19 cases of infection.
One pet that tested positive was Phoenix, a 7-year-old part Siamese cat owned by Kaitlyn Romoser, who works in a university lab. Ms. Romoser, 23, was confirmed to have COVID-19 twice, once in March and again in September. The second time she was much sicker, she said, and Phoenix was her constant companion.
“If I would have known animals were just getting it everywhere, I would have tried to distance myself, but he will not distance himself from me,” Ms. Romoser said. “He sleeps in my bed with me. There was absolutely no social distancing.”
Across the country, veterinarians and other researchers are scouring the animal kingdom for signs of the virus that causes COVID-19. At least 2,000 animals in the U.S. have been tested for the coronavirus since the pandemic began, according to federal records. Cats and dogs that were exposed to sick owners represent most of the animals tested and 80% of the positive cases found.
But scientists have cast a wide net investigating other animals that could be at risk. In states from California to Florida, researchers have tested species ranging from farmed minks and zoo cats to unexpected critters like dolphins, armadillos, and anteaters.
The U.S. Department of Agriculture keeps an official tally of confirmed animal COVID cases that stands at several dozen. But that list is a vast undercount of actual infections. In Utah and Wisconsin, for instance, more than 14,000 minks died in recent weeks after contracting COVID infections initially spread by humans.
So far, there’s limited evidence that animals are transmitting the virus to people. Veterinarians emphasize that pet owners appear to be in no danger from their animal companions and should continue to love and care for them. But scientists say continued testing is one way to remain vigilant in the face of a previously unknown pathogen.
“We just know that coronaviruses, as a family, infect a lot of species, mostly mammals,” said Dr. Peter Rabinowitz, a professor of environmental and occupational health sciences and the director of the University of Washington Center for One Health Research in Seattle. “It makes sense to take a species-spanning approach and look at a wide spectrum.”
Much of the testing has been rooted in scientific curiosity. Since the pandemic began, a major puzzle has been how the virus, which likely originated in bats, spread to humans. A leading theory is that it jumped to an intermediate species, still unknown, and then to people.
In April, a 4-year-old Malayan tiger at the Bronx Zoo tested positive for COVID-19 in a first-of-its-kind case after seven big cats showed signs of respiratory illness. The tiger, Nadia, contracted the virus from a caretaker, federal health officials said. Four other tigers and three African lions were also confirmed to be infected.
In Washington state, the site of the first U.S. outbreak in humans, scientists rushed to design a COVID test for animals in March, said Charlie Powell, a spokesperson for the Washington State University College of Veterinary Medicine, Pullman. “We knew with warm-blooded animals, housed together, there’s going to be some cross-infection,” he said. Tests for animals use different reagent compounds than those used for tests in people, so they don’t deplete the human supply, Mr. Powell added.
Since spring, the Washington Animal Disease Diagnostic Laboratory has tested nearly 80 animals, including 38 dogs, 29 cats, 2 ferrets, a camel, and 2 tamanduas, a type of anteater. The lab also tested six minks from the outbreak in Utah, five of which accounted for the lab’s only positive tests.
All told, nearly 1,400 animals have been tested for COVID-19 through the National Animal Health Laboratory Network or private labs, said Lyndsay Cole, a spokesperson for the USDA’s Animal and Plant Health Inspection Service. More than 400 animals have been tested through the National Veterinary Services Laboratories. At least 250 more have been tested through academic research projects.
Most of the tests have been in household cats and dogs with suspicious respiratory symptoms. In June, the USDA reported that a dog in New York was the first pet dog to test positive for the coronavirus after falling ill and struggling to breathe. The dog, a 7-year-old German shepherd named Buddy, later died. Officials determined he’d contracted the virus from his owner.
Neither the Centers for Disease Control and Prevention nor the USDA recommends routine testing for house pets or other animals – but that hasn’t stopped owners from asking, said Dr. Douglas Kratt, president of the American Veterinary Medical Association.
“The questions have become a little more consistent at my practice,” he said. “People do want to know about COVID-19 and their pets. Can their pet pick it up at a clinic or boarding or in doggie day care?”
The answer, so far, is that humans are the primary source of infection in pets. In September, a small, unpublished study from the University of Guelph in Canada found that companion cats and dogs appeared to be infected by their sick owners, judging by antibodies to the coronavirus detected in their blood.
In Texas, Dr. Hamer started testing animals from households where someone had contracted COVID-19 to learn more about transmission pathways. “Right now, we’re very much trying to describe what’s happening in nature,” she said.
So far, most of the animals – including Phoenix, Ms. Romoser’s cat – have shown no signs of illness or disease. That’s true so far for many species of animals tested for COVID-19, veterinarians said. Most nonhuman creatures appear to weather COVID infection with mild symptoms like sniffles and lethargy, if any.
Still, owners should apply best practices for avoiding COVID infection to pets, too, Dr. Kratt said. Don’t let pets come into contact with unfamiliar animals, he suggested. Owners should wash their hands frequently and avoid nuzzling and other very close contact, if possible.
Cats appear to be more susceptible to COVID-19 than dogs, researchers said. And minks, which are farmed in the U.S. and elsewhere for their fur, appear quite vulnerable.
In the meantime, the list of creatures tested for COVID-19 – whether for illness or science – is growing. In Florida, 22 animals had been tested as of early October, including 3 wild dolphins, 2 civets, 2 clouded leopards, a gorilla, an orangutan, an alpaca, and a bush baby, state officials said.
In California, 29 animals had been tested by the end of September, including a meerkat, a monkey, and a coatimundi, a member of the raccoon family.
In Seattle, a plan to test orcas, or killer whales, in Puget Sound was called off at the last minute after a member of the scientific team was exposed to COVID-19 and had to quarantine, said Dr. Joe Gaydos, a senior wildlife veterinarian and science director for the SeaDoc Society, a conservation program at the University of California-Davis. The group missed its September window to locate the animals and obtain breath and fecal samples for analysis.
No one thinks marine animals will play a big role in the pandemic decimating the human population, Dr. Gaydos said. But testing many creatures on both land and sea is vital.
“We don’t know what this virus is going to do or can do,” Dr. Gaydos said.
Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Poor and minority children with food allergies overlooked and in danger
As Emily Brown stood in a food pantry looking at her options, she felt alone. Up to that point, she had never struggled financially. But there she was, desperate to find safe food for her young daughter with food allergies. What she found was a jar of salsa and some potatoes.
“That was all that was available,” said Ms. Brown, who lives in Kansas City, Kansas. “It was just a desperate place.”
When she became a parent, Ms. Brown left her job for lack of child care that would accommodate her daughter’s allergies to peanuts, tree nuts, milk, eggs, wheat, and soy. When she and her husband then turned to a federal food assistance program, they found few allowable allergy substitutions. The closest allergy support group she could find was an hour away. She was almost always the only Black parent, and the only poor parent, there.
Ms. Brown called national food allergy advocacy organizations to ask for guidance to help poor families find safe food and medical resources, but she said she was told that wasn’t their focus. Support groups, fundraising activities, and advocacy efforts, plus clinical and research outreach, were targeted at wealthier – and White – families. Advertising rarely reflected families that looked like hers. She felt unseen.
“In many ways, food allergy is an invisible disease. The burden of the disease, the activities and energy it takes to avoid allergens, are mostly invisible to those not impacted,” Ms. Brown said. “Black and other minority patients often lack voice and visibility in the health care system. Add the additional burden of an invisible condition and you are in a really vulnerable position.”
An estimated 6 million children in the United States have food allergies, 40% of them with more than one. Though limited research has been done on race and class breakdowns, recent studies show that poor children and some groups of minority children not only have a higher incidence of food allergies than White children, but their families also have more difficulty accessing appropriate child care, safe food, medical care, and lifesaving medicine like epinephrine for them.
Black children are 7% more likely to have food allergies than white children, according to a 2020 study by Dr. Ruchi Gupta, MD, at Northwestern University, Chicago. To be sure, the study shows that Asian children are 24% more likely than White children to have food allergies. But Black and Hispanic children are disproportionately more likely to live in poor communities, to have asthma, and to suffer from systemic racism in the delivery of medical care.
“Many times, a mother is frank and says: ‘I have $20-$40 to buy groceries for the week, and if I buy these foods that you are telling me to buy, I will not be able to feed my entire family,’” said Carla Davis, MD, director of the food allergy program at Houston’s Texas Children’s Hospital. “If you are diagnosed with a food allergy and you don’t have disposable income or disposable time, there is really no way that you will be able to alter your diet in a way that your child is going to stay away from their allergen.”
Fed up with the lack of support, Ms. Brown founded the Food Equality Initiative advocacy organization in 2014. It offers an online marketplace to income-eligible families in Kansas and Missouri who, with a doctor’s note about the allergy, can order free allergy-safe food to fit their needs.
Nationwide, though, families’ needs far outstrip what her group can offer – and the problem has gotten worse amid the economic squeeze of the COVID pandemic. Job losses and business closures have exacerbated the barriers to finding and affording nutritious food, according to a report from Feeding America, an association of food banks.
Ms. Brown said her organization more than doubled its clientele in March through August, compared with the same period in 2019. And though it currently serves only Missouri and Kansas, she said the organization has been fielding an increasing number of calls from across the country since the pandemic began.
For low-income minorities, who live disproportionately in food deserts, fresh and allergy-friendly foods can be especially expensive and difficult to find in the best of times.
Food assistance programs are heavily weighted to prepackaged and processed foods, which often include the very ingredients that are problematic. Black children are more likely to be allergic to wheat and soy than White children, and both Black and Hispanic children are more likely to be allergic to corn, shellfish, and fish, according to a 2016 study.
Some programs allow few allergy substitutions. For example, the federal Special Supplemental Nutrition Program for Women, Infants, and Children allows only canned beans as a substitute for peanut butter. While nutritionally similar, beans are not as easy to pack for a kid’s lunch. Ms. Brown questions why WIC won’t allow a seed butter, such as sunflower butter, instead. She said they are nutritionally and functionally similar and are offered as allergy substitutions in other food programs.
Making matters worse, low-income households pay more than twice as much as higher-income families for the emergency medical care their children receive for their allergies, according to a 2016 study by Dr. Gupta. The kids often arrive at the hospital in more distress because they lack safe food and allergy medications – and because asthma, which disproportionately hits Black and Puerto Rican children and low-income communities, complicates allergic reactions.
“So, in these vulnerable populations, it’s like a double whammy, and we see that reflected in the data,” said Lakiea Wright-Bello, MD, a medical director in specialty diagnostics at Thermo Fisher Scientific and an allergist at Brigham and Women’s Hospital in Boston.
Thomas and Dina Silvera, who are Black and Latina, lived this horror firsthand. After their 3-year-old son, Elijah-Alavi, died as a result of a dairy allergy when fed a grilled cheese instead of his allergen-free food at his preschool, they launched the Elijah-Alavi Foundation to address the dearth of information about food allergies and the critical lack of culturally sensitive medical care in low-income communities.
“We started it for a cause, not because we wanted to, but because we had to,” said Thomas Silvera. “Our main focus is to bring to underserved communities – especially communities of color – this information at no cost to them.”
Recently, other advocacy groups, including Food Allergy Research & Education, a national advocacy organization, also have started to turn their attention to a lack of access and support in poor and minority communities. When Lisa Gable, who is White, took over at the group known as FARE in 2018, she began to diversify the organization internally and to make it more inclusive.
“There wasn’t a big tent when I walked in the door,” said Ms. Gable. “What we have been focused on doing is trying to find partners and relationships that will allow us to diversify those engaged in the community, because it has not been a diverse community.”
FARE has funded research into the cost of food allergies. It is also expanding its patient registry, which collects data for research, as well as its clinical network of medical institutions to include more diverse communities.
Dr. Gupta is now leading one of the first studies funded by the National Institutes of Health to investigate food allergy in children by race and ethnicity. It looks at all aspects of food allergies, including family life, management, access to care, and genetics.
“That’s a big deal,” said Dr. Gupta. “Because if we really want to improve food allergy management, care and understanding, we really need to understand how it impacts different groups. And that hasn’t been done.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
As Emily Brown stood in a food pantry looking at her options, she felt alone. Up to that point, she had never struggled financially. But there she was, desperate to find safe food for her young daughter with food allergies. What she found was a jar of salsa and some potatoes.
“That was all that was available,” said Ms. Brown, who lives in Kansas City, Kansas. “It was just a desperate place.”
When she became a parent, Ms. Brown left her job for lack of child care that would accommodate her daughter’s allergies to peanuts, tree nuts, milk, eggs, wheat, and soy. When she and her husband then turned to a federal food assistance program, they found few allowable allergy substitutions. The closest allergy support group she could find was an hour away. She was almost always the only Black parent, and the only poor parent, there.
Ms. Brown called national food allergy advocacy organizations to ask for guidance to help poor families find safe food and medical resources, but she said she was told that wasn’t their focus. Support groups, fundraising activities, and advocacy efforts, plus clinical and research outreach, were targeted at wealthier – and White – families. Advertising rarely reflected families that looked like hers. She felt unseen.
“In many ways, food allergy is an invisible disease. The burden of the disease, the activities and energy it takes to avoid allergens, are mostly invisible to those not impacted,” Ms. Brown said. “Black and other minority patients often lack voice and visibility in the health care system. Add the additional burden of an invisible condition and you are in a really vulnerable position.”
An estimated 6 million children in the United States have food allergies, 40% of them with more than one. Though limited research has been done on race and class breakdowns, recent studies show that poor children and some groups of minority children not only have a higher incidence of food allergies than White children, but their families also have more difficulty accessing appropriate child care, safe food, medical care, and lifesaving medicine like epinephrine for them.
Black children are 7% more likely to have food allergies than white children, according to a 2020 study by Dr. Ruchi Gupta, MD, at Northwestern University, Chicago. To be sure, the study shows that Asian children are 24% more likely than White children to have food allergies. But Black and Hispanic children are disproportionately more likely to live in poor communities, to have asthma, and to suffer from systemic racism in the delivery of medical care.
“Many times, a mother is frank and says: ‘I have $20-$40 to buy groceries for the week, and if I buy these foods that you are telling me to buy, I will not be able to feed my entire family,’” said Carla Davis, MD, director of the food allergy program at Houston’s Texas Children’s Hospital. “If you are diagnosed with a food allergy and you don’t have disposable income or disposable time, there is really no way that you will be able to alter your diet in a way that your child is going to stay away from their allergen.”
Fed up with the lack of support, Ms. Brown founded the Food Equality Initiative advocacy organization in 2014. It offers an online marketplace to income-eligible families in Kansas and Missouri who, with a doctor’s note about the allergy, can order free allergy-safe food to fit their needs.
Nationwide, though, families’ needs far outstrip what her group can offer – and the problem has gotten worse amid the economic squeeze of the COVID pandemic. Job losses and business closures have exacerbated the barriers to finding and affording nutritious food, according to a report from Feeding America, an association of food banks.
Ms. Brown said her organization more than doubled its clientele in March through August, compared with the same period in 2019. And though it currently serves only Missouri and Kansas, she said the organization has been fielding an increasing number of calls from across the country since the pandemic began.
For low-income minorities, who live disproportionately in food deserts, fresh and allergy-friendly foods can be especially expensive and difficult to find in the best of times.
Food assistance programs are heavily weighted to prepackaged and processed foods, which often include the very ingredients that are problematic. Black children are more likely to be allergic to wheat and soy than White children, and both Black and Hispanic children are more likely to be allergic to corn, shellfish, and fish, according to a 2016 study.
Some programs allow few allergy substitutions. For example, the federal Special Supplemental Nutrition Program for Women, Infants, and Children allows only canned beans as a substitute for peanut butter. While nutritionally similar, beans are not as easy to pack for a kid’s lunch. Ms. Brown questions why WIC won’t allow a seed butter, such as sunflower butter, instead. She said they are nutritionally and functionally similar and are offered as allergy substitutions in other food programs.
Making matters worse, low-income households pay more than twice as much as higher-income families for the emergency medical care their children receive for their allergies, according to a 2016 study by Dr. Gupta. The kids often arrive at the hospital in more distress because they lack safe food and allergy medications – and because asthma, which disproportionately hits Black and Puerto Rican children and low-income communities, complicates allergic reactions.
“So, in these vulnerable populations, it’s like a double whammy, and we see that reflected in the data,” said Lakiea Wright-Bello, MD, a medical director in specialty diagnostics at Thermo Fisher Scientific and an allergist at Brigham and Women’s Hospital in Boston.
Thomas and Dina Silvera, who are Black and Latina, lived this horror firsthand. After their 3-year-old son, Elijah-Alavi, died as a result of a dairy allergy when fed a grilled cheese instead of his allergen-free food at his preschool, they launched the Elijah-Alavi Foundation to address the dearth of information about food allergies and the critical lack of culturally sensitive medical care in low-income communities.
“We started it for a cause, not because we wanted to, but because we had to,” said Thomas Silvera. “Our main focus is to bring to underserved communities – especially communities of color – this information at no cost to them.”
Recently, other advocacy groups, including Food Allergy Research & Education, a national advocacy organization, also have started to turn their attention to a lack of access and support in poor and minority communities. When Lisa Gable, who is White, took over at the group known as FARE in 2018, she began to diversify the organization internally and to make it more inclusive.
“There wasn’t a big tent when I walked in the door,” said Ms. Gable. “What we have been focused on doing is trying to find partners and relationships that will allow us to diversify those engaged in the community, because it has not been a diverse community.”
FARE has funded research into the cost of food allergies. It is also expanding its patient registry, which collects data for research, as well as its clinical network of medical institutions to include more diverse communities.
Dr. Gupta is now leading one of the first studies funded by the National Institutes of Health to investigate food allergy in children by race and ethnicity. It looks at all aspects of food allergies, including family life, management, access to care, and genetics.
“That’s a big deal,” said Dr. Gupta. “Because if we really want to improve food allergy management, care and understanding, we really need to understand how it impacts different groups. And that hasn’t been done.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
As Emily Brown stood in a food pantry looking at her options, she felt alone. Up to that point, she had never struggled financially. But there she was, desperate to find safe food for her young daughter with food allergies. What she found was a jar of salsa and some potatoes.
“That was all that was available,” said Ms. Brown, who lives in Kansas City, Kansas. “It was just a desperate place.”
When she became a parent, Ms. Brown left her job for lack of child care that would accommodate her daughter’s allergies to peanuts, tree nuts, milk, eggs, wheat, and soy. When she and her husband then turned to a federal food assistance program, they found few allowable allergy substitutions. The closest allergy support group she could find was an hour away. She was almost always the only Black parent, and the only poor parent, there.
Ms. Brown called national food allergy advocacy organizations to ask for guidance to help poor families find safe food and medical resources, but she said she was told that wasn’t their focus. Support groups, fundraising activities, and advocacy efforts, plus clinical and research outreach, were targeted at wealthier – and White – families. Advertising rarely reflected families that looked like hers. She felt unseen.
“In many ways, food allergy is an invisible disease. The burden of the disease, the activities and energy it takes to avoid allergens, are mostly invisible to those not impacted,” Ms. Brown said. “Black and other minority patients often lack voice and visibility in the health care system. Add the additional burden of an invisible condition and you are in a really vulnerable position.”
An estimated 6 million children in the United States have food allergies, 40% of them with more than one. Though limited research has been done on race and class breakdowns, recent studies show that poor children and some groups of minority children not only have a higher incidence of food allergies than White children, but their families also have more difficulty accessing appropriate child care, safe food, medical care, and lifesaving medicine like epinephrine for them.
Black children are 7% more likely to have food allergies than white children, according to a 2020 study by Dr. Ruchi Gupta, MD, at Northwestern University, Chicago. To be sure, the study shows that Asian children are 24% more likely than White children to have food allergies. But Black and Hispanic children are disproportionately more likely to live in poor communities, to have asthma, and to suffer from systemic racism in the delivery of medical care.
“Many times, a mother is frank and says: ‘I have $20-$40 to buy groceries for the week, and if I buy these foods that you are telling me to buy, I will not be able to feed my entire family,’” said Carla Davis, MD, director of the food allergy program at Houston’s Texas Children’s Hospital. “If you are diagnosed with a food allergy and you don’t have disposable income or disposable time, there is really no way that you will be able to alter your diet in a way that your child is going to stay away from their allergen.”
Fed up with the lack of support, Ms. Brown founded the Food Equality Initiative advocacy organization in 2014. It offers an online marketplace to income-eligible families in Kansas and Missouri who, with a doctor’s note about the allergy, can order free allergy-safe food to fit their needs.
Nationwide, though, families’ needs far outstrip what her group can offer – and the problem has gotten worse amid the economic squeeze of the COVID pandemic. Job losses and business closures have exacerbated the barriers to finding and affording nutritious food, according to a report from Feeding America, an association of food banks.
Ms. Brown said her organization more than doubled its clientele in March through August, compared with the same period in 2019. And though it currently serves only Missouri and Kansas, she said the organization has been fielding an increasing number of calls from across the country since the pandemic began.
For low-income minorities, who live disproportionately in food deserts, fresh and allergy-friendly foods can be especially expensive and difficult to find in the best of times.
Food assistance programs are heavily weighted to prepackaged and processed foods, which often include the very ingredients that are problematic. Black children are more likely to be allergic to wheat and soy than White children, and both Black and Hispanic children are more likely to be allergic to corn, shellfish, and fish, according to a 2016 study.
Some programs allow few allergy substitutions. For example, the federal Special Supplemental Nutrition Program for Women, Infants, and Children allows only canned beans as a substitute for peanut butter. While nutritionally similar, beans are not as easy to pack for a kid’s lunch. Ms. Brown questions why WIC won’t allow a seed butter, such as sunflower butter, instead. She said they are nutritionally and functionally similar and are offered as allergy substitutions in other food programs.
Making matters worse, low-income households pay more than twice as much as higher-income families for the emergency medical care their children receive for their allergies, according to a 2016 study by Dr. Gupta. The kids often arrive at the hospital in more distress because they lack safe food and allergy medications – and because asthma, which disproportionately hits Black and Puerto Rican children and low-income communities, complicates allergic reactions.
“So, in these vulnerable populations, it’s like a double whammy, and we see that reflected in the data,” said Lakiea Wright-Bello, MD, a medical director in specialty diagnostics at Thermo Fisher Scientific and an allergist at Brigham and Women’s Hospital in Boston.
Thomas and Dina Silvera, who are Black and Latina, lived this horror firsthand. After their 3-year-old son, Elijah-Alavi, died as a result of a dairy allergy when fed a grilled cheese instead of his allergen-free food at his preschool, they launched the Elijah-Alavi Foundation to address the dearth of information about food allergies and the critical lack of culturally sensitive medical care in low-income communities.
“We started it for a cause, not because we wanted to, but because we had to,” said Thomas Silvera. “Our main focus is to bring to underserved communities – especially communities of color – this information at no cost to them.”
Recently, other advocacy groups, including Food Allergy Research & Education, a national advocacy organization, also have started to turn their attention to a lack of access and support in poor and minority communities. When Lisa Gable, who is White, took over at the group known as FARE in 2018, she began to diversify the organization internally and to make it more inclusive.
“There wasn’t a big tent when I walked in the door,” said Ms. Gable. “What we have been focused on doing is trying to find partners and relationships that will allow us to diversify those engaged in the community, because it has not been a diverse community.”
FARE has funded research into the cost of food allergies. It is also expanding its patient registry, which collects data for research, as well as its clinical network of medical institutions to include more diverse communities.
Dr. Gupta is now leading one of the first studies funded by the National Institutes of Health to investigate food allergy in children by race and ethnicity. It looks at all aspects of food allergies, including family life, management, access to care, and genetics.
“That’s a big deal,” said Dr. Gupta. “Because if we really want to improve food allergy management, care and understanding, we really need to understand how it impacts different groups. And that hasn’t been done.”
KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.
Common SARS-CoV-2 mutation may be making COVID-19 more contagious
Most SARS-CoV-2 virus strains feature a specific mutation that makes them more transmissible, to the point that these strains now predominate globally, new evidence shows.
In contrast to a greater variety of strains early in the pandemic, now 99.9% of circulating SARS-CoV-2 strains in the study feature the D614G mutation on the spike protein. In addition, people infected with a D614G strain have higher nasopharynx viral loads at diagnosis.
It’s not all bad news. This single-point mutation was not associated with worse clinical COVID-19 severity. Also, the mutation isn’t expected to interfere with the efficacy any of the antibody cocktails, small molecule therapies or vaccines in development.
Furthermore, “as bad as SARS-CoV-2 is, we may have dodged a bullet in terms of how quickly it mutates,” study author Ilya Finkelstein, PhD, said in an interview. This virus mutates much slower than HIV, for example, giving researchers a greater chance to stay one step ahead, he said.
The study was published online Oct. 30 in the journal mBio.
Molecular sleuthing
The research was possible because colleagues at the Houston Methodist Hospital system sequenced the genome of 5085 SARS-CoV-2 strains early in the outbreak and during a second wave of infection over the summer, Dr. Finkelstein said.
The unique data source also includes information from plasma, convalescent plasma, and patient outcomes. Studying a large and diverse population in a major metropolitan area like Houston helps create a “molecular fingerprint” for the virus that will continue to be very useful, said Dr. Finkelstein, a researcher and director of the Finkelstein Lab at the University of Texas, Austin.
D614G was the most common genetic substitution the researchers found, appearing in 82% of SARS-CoV-2 strains during the first wave from March 5 to May 11. The proportion with this mutation jumped to 99.9% by the second wave, defined as occurring between May 12 and July 7 in the study.
The jump in mutation frequency “occurred very rapidly, in a matter of just a few months,” the researchers noted.
The presence of the mutation during the first wave was independently associated with mechanical ventilation days, overall length of stay, and ICU length of stay. However, it was not associated with any significant differences in patient outcomes.
The D614G mutation is now so common worldwide that these viruses are considered reference strains. Researchers believe D614G predominates because it increases the spike protein’s ability to open cells for the virus to enter.
Despite the large number of virus strains evaluated, the samples only represent about 10% of COVID-19 cases in Houston during the study, a potential limitation. Also, some collected samples could not be used for high-quality genome analysis because of limited virus nucleic acid.
Also, it remains unclear if host-virus immune interactions play a significant role. However, the researchers noted in the paper that “available data suggest that, in the aggregate, host genetics does not play an overwhelming role in determining outcome in the great majority of adult patients, once virus infection is established.”
Surveillance ongoing
“The findings will help us to understand the origin, composition, and trajectory of future infection waves and the potential effect of the host immune response and therapeutic maneuvers on SARS-CoV-2 evolution,” the researchers added.
Going forward, the ongoing molecular surveillance of SARS-CoV-2 “may provide critical insights into the origin of the new infection spikes and waves that are occurring as public health constraints are further relaxed, schools and colleges reopen, holidays occur, commercial air travel increases and individuals change their behavior because of COVID-19 ‘fatigue,’ ” the researchers noted.
They added that the genome data will also be useful in assessing ongoing molecular evolution in spike and other proteins “as baseline herd immunity is generated, either by natural exposure to SARS-CoV-2 or by vaccination.”
Further validation warranted
“The study is very interesting and well performed,” Noam Shomron, PhD, a member of the faculty of medicine at Tel Aviv University, said in an interview.
Analyzing the “SARS-CoV-2 molecular evolution in a specific region in the USA … could be viewed as a microcosm of what occurs in other large cities in the USA,” he said.
However, “before jumping to conclusions, this should be further validated,” added Dr. Shomron, who authored a study suggesting differences in genetic alleles could partially explain variations across countries in the infection rates, severity, and mortality associated with SARS-CoV-2.
“We know that many other features and contributors might affect the results – even social constraints could generate a bias in the observations,” he said.
Dr. Finkelstein and Dr. Shomron disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Most SARS-CoV-2 virus strains feature a specific mutation that makes them more transmissible, to the point that these strains now predominate globally, new evidence shows.
In contrast to a greater variety of strains early in the pandemic, now 99.9% of circulating SARS-CoV-2 strains in the study feature the D614G mutation on the spike protein. In addition, people infected with a D614G strain have higher nasopharynx viral loads at diagnosis.
It’s not all bad news. This single-point mutation was not associated with worse clinical COVID-19 severity. Also, the mutation isn’t expected to interfere with the efficacy any of the antibody cocktails, small molecule therapies or vaccines in development.
Furthermore, “as bad as SARS-CoV-2 is, we may have dodged a bullet in terms of how quickly it mutates,” study author Ilya Finkelstein, PhD, said in an interview. This virus mutates much slower than HIV, for example, giving researchers a greater chance to stay one step ahead, he said.
The study was published online Oct. 30 in the journal mBio.
Molecular sleuthing
The research was possible because colleagues at the Houston Methodist Hospital system sequenced the genome of 5085 SARS-CoV-2 strains early in the outbreak and during a second wave of infection over the summer, Dr. Finkelstein said.
The unique data source also includes information from plasma, convalescent plasma, and patient outcomes. Studying a large and diverse population in a major metropolitan area like Houston helps create a “molecular fingerprint” for the virus that will continue to be very useful, said Dr. Finkelstein, a researcher and director of the Finkelstein Lab at the University of Texas, Austin.
D614G was the most common genetic substitution the researchers found, appearing in 82% of SARS-CoV-2 strains during the first wave from March 5 to May 11. The proportion with this mutation jumped to 99.9% by the second wave, defined as occurring between May 12 and July 7 in the study.
The jump in mutation frequency “occurred very rapidly, in a matter of just a few months,” the researchers noted.
The presence of the mutation during the first wave was independently associated with mechanical ventilation days, overall length of stay, and ICU length of stay. However, it was not associated with any significant differences in patient outcomes.
The D614G mutation is now so common worldwide that these viruses are considered reference strains. Researchers believe D614G predominates because it increases the spike protein’s ability to open cells for the virus to enter.
Despite the large number of virus strains evaluated, the samples only represent about 10% of COVID-19 cases in Houston during the study, a potential limitation. Also, some collected samples could not be used for high-quality genome analysis because of limited virus nucleic acid.
Also, it remains unclear if host-virus immune interactions play a significant role. However, the researchers noted in the paper that “available data suggest that, in the aggregate, host genetics does not play an overwhelming role in determining outcome in the great majority of adult patients, once virus infection is established.”
Surveillance ongoing
“The findings will help us to understand the origin, composition, and trajectory of future infection waves and the potential effect of the host immune response and therapeutic maneuvers on SARS-CoV-2 evolution,” the researchers added.
Going forward, the ongoing molecular surveillance of SARS-CoV-2 “may provide critical insights into the origin of the new infection spikes and waves that are occurring as public health constraints are further relaxed, schools and colleges reopen, holidays occur, commercial air travel increases and individuals change their behavior because of COVID-19 ‘fatigue,’ ” the researchers noted.
They added that the genome data will also be useful in assessing ongoing molecular evolution in spike and other proteins “as baseline herd immunity is generated, either by natural exposure to SARS-CoV-2 or by vaccination.”
Further validation warranted
“The study is very interesting and well performed,” Noam Shomron, PhD, a member of the faculty of medicine at Tel Aviv University, said in an interview.
Analyzing the “SARS-CoV-2 molecular evolution in a specific region in the USA … could be viewed as a microcosm of what occurs in other large cities in the USA,” he said.
However, “before jumping to conclusions, this should be further validated,” added Dr. Shomron, who authored a study suggesting differences in genetic alleles could partially explain variations across countries in the infection rates, severity, and mortality associated with SARS-CoV-2.
“We know that many other features and contributors might affect the results – even social constraints could generate a bias in the observations,” he said.
Dr. Finkelstein and Dr. Shomron disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Most SARS-CoV-2 virus strains feature a specific mutation that makes them more transmissible, to the point that these strains now predominate globally, new evidence shows.
In contrast to a greater variety of strains early in the pandemic, now 99.9% of circulating SARS-CoV-2 strains in the study feature the D614G mutation on the spike protein. In addition, people infected with a D614G strain have higher nasopharynx viral loads at diagnosis.
It’s not all bad news. This single-point mutation was not associated with worse clinical COVID-19 severity. Also, the mutation isn’t expected to interfere with the efficacy any of the antibody cocktails, small molecule therapies or vaccines in development.
Furthermore, “as bad as SARS-CoV-2 is, we may have dodged a bullet in terms of how quickly it mutates,” study author Ilya Finkelstein, PhD, said in an interview. This virus mutates much slower than HIV, for example, giving researchers a greater chance to stay one step ahead, he said.
The study was published online Oct. 30 in the journal mBio.
Molecular sleuthing
The research was possible because colleagues at the Houston Methodist Hospital system sequenced the genome of 5085 SARS-CoV-2 strains early in the outbreak and during a second wave of infection over the summer, Dr. Finkelstein said.
The unique data source also includes information from plasma, convalescent plasma, and patient outcomes. Studying a large and diverse population in a major metropolitan area like Houston helps create a “molecular fingerprint” for the virus that will continue to be very useful, said Dr. Finkelstein, a researcher and director of the Finkelstein Lab at the University of Texas, Austin.
D614G was the most common genetic substitution the researchers found, appearing in 82% of SARS-CoV-2 strains during the first wave from March 5 to May 11. The proportion with this mutation jumped to 99.9% by the second wave, defined as occurring between May 12 and July 7 in the study.
The jump in mutation frequency “occurred very rapidly, in a matter of just a few months,” the researchers noted.
The presence of the mutation during the first wave was independently associated with mechanical ventilation days, overall length of stay, and ICU length of stay. However, it was not associated with any significant differences in patient outcomes.
The D614G mutation is now so common worldwide that these viruses are considered reference strains. Researchers believe D614G predominates because it increases the spike protein’s ability to open cells for the virus to enter.
Despite the large number of virus strains evaluated, the samples only represent about 10% of COVID-19 cases in Houston during the study, a potential limitation. Also, some collected samples could not be used for high-quality genome analysis because of limited virus nucleic acid.
Also, it remains unclear if host-virus immune interactions play a significant role. However, the researchers noted in the paper that “available data suggest that, in the aggregate, host genetics does not play an overwhelming role in determining outcome in the great majority of adult patients, once virus infection is established.”
Surveillance ongoing
“The findings will help us to understand the origin, composition, and trajectory of future infection waves and the potential effect of the host immune response and therapeutic maneuvers on SARS-CoV-2 evolution,” the researchers added.
Going forward, the ongoing molecular surveillance of SARS-CoV-2 “may provide critical insights into the origin of the new infection spikes and waves that are occurring as public health constraints are further relaxed, schools and colleges reopen, holidays occur, commercial air travel increases and individuals change their behavior because of COVID-19 ‘fatigue,’ ” the researchers noted.
They added that the genome data will also be useful in assessing ongoing molecular evolution in spike and other proteins “as baseline herd immunity is generated, either by natural exposure to SARS-CoV-2 or by vaccination.”
Further validation warranted
“The study is very interesting and well performed,” Noam Shomron, PhD, a member of the faculty of medicine at Tel Aviv University, said in an interview.
Analyzing the “SARS-CoV-2 molecular evolution in a specific region in the USA … could be viewed as a microcosm of what occurs in other large cities in the USA,” he said.
However, “before jumping to conclusions, this should be further validated,” added Dr. Shomron, who authored a study suggesting differences in genetic alleles could partially explain variations across countries in the infection rates, severity, and mortality associated with SARS-CoV-2.
“We know that many other features and contributors might affect the results – even social constraints could generate a bias in the observations,” he said.
Dr. Finkelstein and Dr. Shomron disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Obesity biggest risk for COVID-19 pneumonia, after age, male sex
In a large international study of patients admitted to the ICU with COVID-19, the likelihood of having severe pneumonia (i.e., needing invasive mechanical ventilation) increased stepwise with increasing body mass index (BMI) – independent of diabetes, hypertension, dyslipidemia, or current smoking.
The main finding was a linear correlation between BMI and need for invasive mechanical ventilation, after adjustment for center, age, sex, and other prespecified metabolic risk factors.
Risk was “highest for older people and males, but the next most important risk factor to developing severe pneumonia if infected [was] obesity,” said François Pattou, MD, Centre Hospitalier Universitaire de Lille (France), who presented the findings at the ObesityWeek 2020 virtual meeting. The results were also recently published in a preprint article in The Lancet.
Dr. Pattou and colleagues first reported back in April that obesity is one of the biggest risk factors for severe COVID-19 infection, especially in younger patients. Many further reports linked the two, and the French researchers then set out to conduct the current large, international, multicenter cohort study.
“The high number of patients included here [allowed us] to disentangle the role of various metabolic cofactors and to show that obesity, not diabetes or hypertension, was the main determinant of severe pneumonia [after age and gender],” Dr. Pattou said in an interview.
And the impact of obesity was most pronounced in women younger than 50 years.
Patients with severe obesity must protect themselves
Of interest, the study also found an “obesity paradox” for mortality after admission to the ICU.
Specifically, compared with leaner patients (BMI < 25 kg/m2), those with severe obesity (obesity class III, BMI ≥ 40) had an increased risk of dying within 28 days of admission to ICU. But patients with overweight to moderate obesity (BMI 25-39.9) had a lower risk of this outcome.
“The second original finding of our study,” Dr. Pattou continued, was the “nonlinear relation observed between BMI and all-cause mortality rate in ICU patients.”
Matteo Rottoli, MD, PhD, author of a related study reported by in July, said the new trial “confirms the findings of our study, which are that obesity is an independent risk factor for intensive care admission and death.”
Dr. Rottoli, from Alma Mater Studiorum, University of Bologna, Italy, and colleagues found that in their population of patients with COVID-19, a BMI > 35 was associated with a greater risk of death.
The takeaway message from the research is that “obesity should be considered one of the most important parameters to identify the population at risk” of getting COVID-19 who need to take extra precautions such as social distancing, Dr. Rottoli stressed.
Dr. Pattou agrees, particularly when it comes to severe obesity.
Intensive care physicians have learned a lot in the past months about COVID-19 pneumonia and how to address it (such as not precipitating intubation, using corticosteroids), he explained.
“Importantly, the general population has also learned a lot, and we can hope that patients with obesity, especially those with severe obesity, will take extra measures to protect themselves, resulting in a decrease of the incidence of severe pneumonia in young and severely obese patients,” he added.
Untangling BMI from other metabolic risk factors
Dr. Pattou said that, from Dec. 16, 2019, to Nov. 1, 2020, more than 45 million people worldwide tested positive for COVID-19 and more than 1.2 million people died from it.
Multiple studies have reported that, among people with COVID-19, those with obesity are at higher risk of hospitalization, ICU admission, invasive ventilation, and death, but it had not been clear if BMI was an independent risk factor.
Dr. Pattou and colleagues aimed to examine the relationship between BMI and COVID-19 pneumonia severity, defined by the need for mechanical ventilation (primary outcome), as well as 28-day all-cause mortality (secondary outcome) among patients admitted to the ICU.
They also sought to disentangle the effect of BMI from other metabolic risk factors (diabetes, hypertension, dyslipidemia, and current smoking) and examine the influence of age and sex on outcomes.
They performed a retrospective analysis of 1,461 patients with confirmed COVID-19 (positive reverse polymerase chain reaction test using a nasal or pharyngeal swab specimen) who were admitted to the ICU at 21 centers from Feb. 19 to May 11, 2020.
Participating centers were in France (13), Italy (3), the United States (1 in New York and 1 in Providence, R.I.), Israel (1), Belgium (1), and Spain (1).
Close to three-quarters of patients were men (73%), which is similar to multiple other studies, Dr. Pattou said. Patients were a mean age of 64 years and had a mean BMI of 28.1.
Half of patients had hypertension (52%), 29% had diabetes, 29% had hyperlipidemia, and 6.5% were current smokers.
Close to three-quarters (74%) required invasive mechanical ventilation, and 36% died within 28 days of ICU admission.
Each 5-kg/m2 increase in BMI was associated with a 27% increased risk of mechanical ventilation in the overall cohort and a 65% increased risk of this outcome among women younger than 50 years, after adjustment for other risk factors.
Male sex and each 10-year increase in age were associated with an 82% and a 17% increased risk of ventilation, respectively, but hypertension, diabetes, hyperlipidemia, and current smoking were not associated with a greater risk. After adjustment for center, age, sex, and prespecified metabolic risk factors, obesity class III (BMI ≥ 40) was associated with a 68% increase in mortality, compared with the risk seen in lean patients.
The findings were similar across different centers.
“To our knowledge, this study represents the first international collaborative effort to explore the association of BMI with the outcomes of pneumonia among COVID-19 patients admitted to ICU,” said the investigators.
They conclude that “available evidence should foster more focused and effective interventions in COVID-19 patients with the highest risk of severe pneumonia, in order to reduce future strain on intensive care resources worldwide, and inform physio-pathological research to elucidate the mechanism of severe lung damage in COVID-19.”
The study did not receive specific funding. The authors have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
In a large international study of patients admitted to the ICU with COVID-19, the likelihood of having severe pneumonia (i.e., needing invasive mechanical ventilation) increased stepwise with increasing body mass index (BMI) – independent of diabetes, hypertension, dyslipidemia, or current smoking.
The main finding was a linear correlation between BMI and need for invasive mechanical ventilation, after adjustment for center, age, sex, and other prespecified metabolic risk factors.
Risk was “highest for older people and males, but the next most important risk factor to developing severe pneumonia if infected [was] obesity,” said François Pattou, MD, Centre Hospitalier Universitaire de Lille (France), who presented the findings at the ObesityWeek 2020 virtual meeting. The results were also recently published in a preprint article in The Lancet.
Dr. Pattou and colleagues first reported back in April that obesity is one of the biggest risk factors for severe COVID-19 infection, especially in younger patients. Many further reports linked the two, and the French researchers then set out to conduct the current large, international, multicenter cohort study.
“The high number of patients included here [allowed us] to disentangle the role of various metabolic cofactors and to show that obesity, not diabetes or hypertension, was the main determinant of severe pneumonia [after age and gender],” Dr. Pattou said in an interview.
And the impact of obesity was most pronounced in women younger than 50 years.
Patients with severe obesity must protect themselves
Of interest, the study also found an “obesity paradox” for mortality after admission to the ICU.
Specifically, compared with leaner patients (BMI < 25 kg/m2), those with severe obesity (obesity class III, BMI ≥ 40) had an increased risk of dying within 28 days of admission to ICU. But patients with overweight to moderate obesity (BMI 25-39.9) had a lower risk of this outcome.
“The second original finding of our study,” Dr. Pattou continued, was the “nonlinear relation observed between BMI and all-cause mortality rate in ICU patients.”
Matteo Rottoli, MD, PhD, author of a related study reported by in July, said the new trial “confirms the findings of our study, which are that obesity is an independent risk factor for intensive care admission and death.”
Dr. Rottoli, from Alma Mater Studiorum, University of Bologna, Italy, and colleagues found that in their population of patients with COVID-19, a BMI > 35 was associated with a greater risk of death.
The takeaway message from the research is that “obesity should be considered one of the most important parameters to identify the population at risk” of getting COVID-19 who need to take extra precautions such as social distancing, Dr. Rottoli stressed.
Dr. Pattou agrees, particularly when it comes to severe obesity.
Intensive care physicians have learned a lot in the past months about COVID-19 pneumonia and how to address it (such as not precipitating intubation, using corticosteroids), he explained.
“Importantly, the general population has also learned a lot, and we can hope that patients with obesity, especially those with severe obesity, will take extra measures to protect themselves, resulting in a decrease of the incidence of severe pneumonia in young and severely obese patients,” he added.
Untangling BMI from other metabolic risk factors
Dr. Pattou said that, from Dec. 16, 2019, to Nov. 1, 2020, more than 45 million people worldwide tested positive for COVID-19 and more than 1.2 million people died from it.
Multiple studies have reported that, among people with COVID-19, those with obesity are at higher risk of hospitalization, ICU admission, invasive ventilation, and death, but it had not been clear if BMI was an independent risk factor.
Dr. Pattou and colleagues aimed to examine the relationship between BMI and COVID-19 pneumonia severity, defined by the need for mechanical ventilation (primary outcome), as well as 28-day all-cause mortality (secondary outcome) among patients admitted to the ICU.
They also sought to disentangle the effect of BMI from other metabolic risk factors (diabetes, hypertension, dyslipidemia, and current smoking) and examine the influence of age and sex on outcomes.
They performed a retrospective analysis of 1,461 patients with confirmed COVID-19 (positive reverse polymerase chain reaction test using a nasal or pharyngeal swab specimen) who were admitted to the ICU at 21 centers from Feb. 19 to May 11, 2020.
Participating centers were in France (13), Italy (3), the United States (1 in New York and 1 in Providence, R.I.), Israel (1), Belgium (1), and Spain (1).
Close to three-quarters of patients were men (73%), which is similar to multiple other studies, Dr. Pattou said. Patients were a mean age of 64 years and had a mean BMI of 28.1.
Half of patients had hypertension (52%), 29% had diabetes, 29% had hyperlipidemia, and 6.5% were current smokers.
Close to three-quarters (74%) required invasive mechanical ventilation, and 36% died within 28 days of ICU admission.
Each 5-kg/m2 increase in BMI was associated with a 27% increased risk of mechanical ventilation in the overall cohort and a 65% increased risk of this outcome among women younger than 50 years, after adjustment for other risk factors.
Male sex and each 10-year increase in age were associated with an 82% and a 17% increased risk of ventilation, respectively, but hypertension, diabetes, hyperlipidemia, and current smoking were not associated with a greater risk. After adjustment for center, age, sex, and prespecified metabolic risk factors, obesity class III (BMI ≥ 40) was associated with a 68% increase in mortality, compared with the risk seen in lean patients.
The findings were similar across different centers.
“To our knowledge, this study represents the first international collaborative effort to explore the association of BMI with the outcomes of pneumonia among COVID-19 patients admitted to ICU,” said the investigators.
They conclude that “available evidence should foster more focused and effective interventions in COVID-19 patients with the highest risk of severe pneumonia, in order to reduce future strain on intensive care resources worldwide, and inform physio-pathological research to elucidate the mechanism of severe lung damage in COVID-19.”
The study did not receive specific funding. The authors have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
In a large international study of patients admitted to the ICU with COVID-19, the likelihood of having severe pneumonia (i.e., needing invasive mechanical ventilation) increased stepwise with increasing body mass index (BMI) – independent of diabetes, hypertension, dyslipidemia, or current smoking.
The main finding was a linear correlation between BMI and need for invasive mechanical ventilation, after adjustment for center, age, sex, and other prespecified metabolic risk factors.
Risk was “highest for older people and males, but the next most important risk factor to developing severe pneumonia if infected [was] obesity,” said François Pattou, MD, Centre Hospitalier Universitaire de Lille (France), who presented the findings at the ObesityWeek 2020 virtual meeting. The results were also recently published in a preprint article in The Lancet.
Dr. Pattou and colleagues first reported back in April that obesity is one of the biggest risk factors for severe COVID-19 infection, especially in younger patients. Many further reports linked the two, and the French researchers then set out to conduct the current large, international, multicenter cohort study.
“The high number of patients included here [allowed us] to disentangle the role of various metabolic cofactors and to show that obesity, not diabetes or hypertension, was the main determinant of severe pneumonia [after age and gender],” Dr. Pattou said in an interview.
And the impact of obesity was most pronounced in women younger than 50 years.
Patients with severe obesity must protect themselves
Of interest, the study also found an “obesity paradox” for mortality after admission to the ICU.
Specifically, compared with leaner patients (BMI < 25 kg/m2), those with severe obesity (obesity class III, BMI ≥ 40) had an increased risk of dying within 28 days of admission to ICU. But patients with overweight to moderate obesity (BMI 25-39.9) had a lower risk of this outcome.
“The second original finding of our study,” Dr. Pattou continued, was the “nonlinear relation observed between BMI and all-cause mortality rate in ICU patients.”
Matteo Rottoli, MD, PhD, author of a related study reported by in July, said the new trial “confirms the findings of our study, which are that obesity is an independent risk factor for intensive care admission and death.”
Dr. Rottoli, from Alma Mater Studiorum, University of Bologna, Italy, and colleagues found that in their population of patients with COVID-19, a BMI > 35 was associated with a greater risk of death.
The takeaway message from the research is that “obesity should be considered one of the most important parameters to identify the population at risk” of getting COVID-19 who need to take extra precautions such as social distancing, Dr. Rottoli stressed.
Dr. Pattou agrees, particularly when it comes to severe obesity.
Intensive care physicians have learned a lot in the past months about COVID-19 pneumonia and how to address it (such as not precipitating intubation, using corticosteroids), he explained.
“Importantly, the general population has also learned a lot, and we can hope that patients with obesity, especially those with severe obesity, will take extra measures to protect themselves, resulting in a decrease of the incidence of severe pneumonia in young and severely obese patients,” he added.
Untangling BMI from other metabolic risk factors
Dr. Pattou said that, from Dec. 16, 2019, to Nov. 1, 2020, more than 45 million people worldwide tested positive for COVID-19 and more than 1.2 million people died from it.
Multiple studies have reported that, among people with COVID-19, those with obesity are at higher risk of hospitalization, ICU admission, invasive ventilation, and death, but it had not been clear if BMI was an independent risk factor.
Dr. Pattou and colleagues aimed to examine the relationship between BMI and COVID-19 pneumonia severity, defined by the need for mechanical ventilation (primary outcome), as well as 28-day all-cause mortality (secondary outcome) among patients admitted to the ICU.
They also sought to disentangle the effect of BMI from other metabolic risk factors (diabetes, hypertension, dyslipidemia, and current smoking) and examine the influence of age and sex on outcomes.
They performed a retrospective analysis of 1,461 patients with confirmed COVID-19 (positive reverse polymerase chain reaction test using a nasal or pharyngeal swab specimen) who were admitted to the ICU at 21 centers from Feb. 19 to May 11, 2020.
Participating centers were in France (13), Italy (3), the United States (1 in New York and 1 in Providence, R.I.), Israel (1), Belgium (1), and Spain (1).
Close to three-quarters of patients were men (73%), which is similar to multiple other studies, Dr. Pattou said. Patients were a mean age of 64 years and had a mean BMI of 28.1.
Half of patients had hypertension (52%), 29% had diabetes, 29% had hyperlipidemia, and 6.5% were current smokers.
Close to three-quarters (74%) required invasive mechanical ventilation, and 36% died within 28 days of ICU admission.
Each 5-kg/m2 increase in BMI was associated with a 27% increased risk of mechanical ventilation in the overall cohort and a 65% increased risk of this outcome among women younger than 50 years, after adjustment for other risk factors.
Male sex and each 10-year increase in age were associated with an 82% and a 17% increased risk of ventilation, respectively, but hypertension, diabetes, hyperlipidemia, and current smoking were not associated with a greater risk. After adjustment for center, age, sex, and prespecified metabolic risk factors, obesity class III (BMI ≥ 40) was associated with a 68% increase in mortality, compared with the risk seen in lean patients.
The findings were similar across different centers.
“To our knowledge, this study represents the first international collaborative effort to explore the association of BMI with the outcomes of pneumonia among COVID-19 patients admitted to ICU,” said the investigators.
They conclude that “available evidence should foster more focused and effective interventions in COVID-19 patients with the highest risk of severe pneumonia, in order to reduce future strain on intensive care resources worldwide, and inform physio-pathological research to elucidate the mechanism of severe lung damage in COVID-19.”
The study did not receive specific funding. The authors have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Information blocking: Adolescent confidentiality is collateral damage
On April 4, 2021, a rule implementing the federal regulations of the Information Blocking 21st Century Cures Act will be enacted. This Act furthers the seamless release of medical records to promote improved outcomes, access to medical information, and transparency of costs.
Each state will need to be thoughtful balancing the action or inaction of allowing access to confidential or sensitive progress notes, as interference with access may be considered information blocking and subject to penalties and fines.With adolescent confidential notes, protection rules may not apply under the information blocking regulations. These regulations will release progress notes, imaging narratives, procedure notes, and labs to parents via their EHR portals. The release of information is not limited, and both inpatient and outpatient records will be released. These regulations are written for adults with the assumption that all information is released to the individual receiving the care and shared with outside providers.
Unfortunately, the rules do not take into consideration adolescent confidential care. There are eight rules for the exception of releasing information, but it may be a stretch to place adolescent confidential progress notes under any of these eight exceptions. These exceptions are ambiguous and open to interpretation yet require specific documentation as to the limitation of access. Exceptions are prevention of harm; privacy conflicts; the security of the electronic health information; infeasibility, which includes challenges limiting the ability to comply; Health IT performance; content and manner; fees; and licensing.
Ms. Thew is medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She had no relevant financial disclosures. Email Ms. Thew at [email protected].
On April 4, 2021, a rule implementing the federal regulations of the Information Blocking 21st Century Cures Act will be enacted. This Act furthers the seamless release of medical records to promote improved outcomes, access to medical information, and transparency of costs.
Each state will need to be thoughtful balancing the action or inaction of allowing access to confidential or sensitive progress notes, as interference with access may be considered information blocking and subject to penalties and fines.With adolescent confidential notes, protection rules may not apply under the information blocking regulations. These regulations will release progress notes, imaging narratives, procedure notes, and labs to parents via their EHR portals. The release of information is not limited, and both inpatient and outpatient records will be released. These regulations are written for adults with the assumption that all information is released to the individual receiving the care and shared with outside providers.
Unfortunately, the rules do not take into consideration adolescent confidential care. There are eight rules for the exception of releasing information, but it may be a stretch to place adolescent confidential progress notes under any of these eight exceptions. These exceptions are ambiguous and open to interpretation yet require specific documentation as to the limitation of access. Exceptions are prevention of harm; privacy conflicts; the security of the electronic health information; infeasibility, which includes challenges limiting the ability to comply; Health IT performance; content and manner; fees; and licensing.
Ms. Thew is medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She had no relevant financial disclosures. Email Ms. Thew at [email protected].
On April 4, 2021, a rule implementing the federal regulations of the Information Blocking 21st Century Cures Act will be enacted. This Act furthers the seamless release of medical records to promote improved outcomes, access to medical information, and transparency of costs.
Each state will need to be thoughtful balancing the action or inaction of allowing access to confidential or sensitive progress notes, as interference with access may be considered information blocking and subject to penalties and fines.With adolescent confidential notes, protection rules may not apply under the information blocking regulations. These regulations will release progress notes, imaging narratives, procedure notes, and labs to parents via their EHR portals. The release of information is not limited, and both inpatient and outpatient records will be released. These regulations are written for adults with the assumption that all information is released to the individual receiving the care and shared with outside providers.
Unfortunately, the rules do not take into consideration adolescent confidential care. There are eight rules for the exception of releasing information, but it may be a stretch to place adolescent confidential progress notes under any of these eight exceptions. These exceptions are ambiguous and open to interpretation yet require specific documentation as to the limitation of access. Exceptions are prevention of harm; privacy conflicts; the security of the electronic health information; infeasibility, which includes challenges limiting the ability to comply; Health IT performance; content and manner; fees; and licensing.
Ms. Thew is medical director of the department of adolescent medicine at Children’s Wisconsin in Milwaukee. She is a member of the Pediatric News editorial advisory board. She had no relevant financial disclosures. Email Ms. Thew at [email protected].
The SHM Fellow designation: Class of 2021
Spotlight on Tanisha Hamilton, MD, FHM
As we navigate a time unlike any other, it is clear that the value hospitalists provide is growing stronger as the hospital medicine field expands. Many Society of Hospital Medicine members look to its Fellows program as a worthwhile opportunity to distinguish themselves as leaders in the field and accelerate their careers in the specialty.
An active member of SHM since 2012 and member of its 2020 class of Fellows, Tanisha Hamilton, MD, FHM, is one of these ambitious individuals.
Dr. Hamilton is based at Baylor University Medical Center in Dallas, an affiliate of Baylor Scott & White Health. Known for personalized health and wellness care, Dr. Hamilton has more than 14 years of experience in the medical field.
Her love for the hospital medicine specialty is rooted in its diversity and complexity of patient cases – something that she knew would innately complement her personality. She says that an invaluable aspect of working in the field is the ability to interact and connect with people from all walks of life.
“My patients keep me motivated in this space. Learning from my patients and having the responsibility of serving as their advocate is incredibly rewarding,” Dr. Hamilton said. “I hope my patients feel like I’ve helped to make a difference in their lives, if only for just a moment.”
When reflecting on why she joined SHM 8 years ago, Dr. Hamilton said she was encouraged to do so because of its like-minded membership community and professional development opportunities, including the Fellows program.
“I applied to SHM’s Fellows program because I’m committed to the specialty. Hospital medicine is an ever-changing field loaded with opportunities to enhance personal and professional career growth,” said Dr. Hamilton. “To me, SHM’s Fellow in Hospital Medicine [FHM] designation demonstrates the ability to make a contribution to the field and to be an instrument for change.”
She credits receiving her designation as a distinction that has opened doors to other career-enhancing opportunities and networking resources, including an expansive global community, program development at her institution, and positions within SHM. Since earning her FHM designation, Dr. Hamilton has become an engaged member of the annual meeting committee and the North Central Texas Chapter.
“Since we are taking our annual conference virtual for SHM Converge in 2021, I’m excited to see how we can transform a meeting of more than 5,000 attendees into a full digital experience with interactive workshops, exhibits, research competitions, and more,” Dr. Hamilton said. “It’s certainly going to be a challenge, but I know that our meetings department and annual conference committee will make it a success!”
As Dr. Hamilton looks forward in her hospital medicine career, she is committed to making a positive impact on the field and for her patients.
In the future, Dr. Hamilton hopes to share curriculum she recently developed and sponsored around diversity, equity, and inclusion with her team at Baylor University Medical Center.
“Following the tragic deaths of numerous individuals, including Breonna Taylor, Ahmaud Abery, and George Floyd, and other people of color who have died because of COVID-19, I have felt compelled to educate my colleagues on how to curtail systemic racism, sexism, religious discrimination, and xenophobia in health care,” Dr. Hamilton said. “This curriculum includes courses on health disparities and cultural competencies, launching a lecture series, and other educational components.”
While 2020 has been a trying year, Dr. Hamilton remains hopeful for a prosperous future.
“When I think of the future of hospital medicine, I am hopeful that hospitalists will have a more prominent role in changing the direction of our health care system,” she said. “The pandemic has made the world realize the importance of hospital medicine. We, as hospitalists, are a critical part of its infrastructure and its success.”
If you would like to join Dr. Hamilton and other like-minded hospital medicine leaders in accelerating your career, SHM is currently recruiting for the Fellows and Senior Fellows class of 2021. Applications are open until Nov. 20, 2020. These designations are available across a variety of membership categories, including physicians, nurse practitioners, physician assistants, and qualified practice administrators. Dedicated to promoting excellence, innovation, and quality improvement in patient care, Fellows designations provide members with a distinguishing credential as established pioneers in the industry.
For more information and to review your eligibility, visit hospitalmedicine.org/fellows.
Ms. Cowan is a communications specialist at the Society of Hospital Medicine.
Spotlight on Tanisha Hamilton, MD, FHM
Spotlight on Tanisha Hamilton, MD, FHM
As we navigate a time unlike any other, it is clear that the value hospitalists provide is growing stronger as the hospital medicine field expands. Many Society of Hospital Medicine members look to its Fellows program as a worthwhile opportunity to distinguish themselves as leaders in the field and accelerate their careers in the specialty.
An active member of SHM since 2012 and member of its 2020 class of Fellows, Tanisha Hamilton, MD, FHM, is one of these ambitious individuals.
Dr. Hamilton is based at Baylor University Medical Center in Dallas, an affiliate of Baylor Scott & White Health. Known for personalized health and wellness care, Dr. Hamilton has more than 14 years of experience in the medical field.
Her love for the hospital medicine specialty is rooted in its diversity and complexity of patient cases – something that she knew would innately complement her personality. She says that an invaluable aspect of working in the field is the ability to interact and connect with people from all walks of life.
“My patients keep me motivated in this space. Learning from my patients and having the responsibility of serving as their advocate is incredibly rewarding,” Dr. Hamilton said. “I hope my patients feel like I’ve helped to make a difference in their lives, if only for just a moment.”
When reflecting on why she joined SHM 8 years ago, Dr. Hamilton said she was encouraged to do so because of its like-minded membership community and professional development opportunities, including the Fellows program.
“I applied to SHM’s Fellows program because I’m committed to the specialty. Hospital medicine is an ever-changing field loaded with opportunities to enhance personal and professional career growth,” said Dr. Hamilton. “To me, SHM’s Fellow in Hospital Medicine [FHM] designation demonstrates the ability to make a contribution to the field and to be an instrument for change.”
She credits receiving her designation as a distinction that has opened doors to other career-enhancing opportunities and networking resources, including an expansive global community, program development at her institution, and positions within SHM. Since earning her FHM designation, Dr. Hamilton has become an engaged member of the annual meeting committee and the North Central Texas Chapter.
“Since we are taking our annual conference virtual for SHM Converge in 2021, I’m excited to see how we can transform a meeting of more than 5,000 attendees into a full digital experience with interactive workshops, exhibits, research competitions, and more,” Dr. Hamilton said. “It’s certainly going to be a challenge, but I know that our meetings department and annual conference committee will make it a success!”
As Dr. Hamilton looks forward in her hospital medicine career, she is committed to making a positive impact on the field and for her patients.
In the future, Dr. Hamilton hopes to share curriculum she recently developed and sponsored around diversity, equity, and inclusion with her team at Baylor University Medical Center.
“Following the tragic deaths of numerous individuals, including Breonna Taylor, Ahmaud Abery, and George Floyd, and other people of color who have died because of COVID-19, I have felt compelled to educate my colleagues on how to curtail systemic racism, sexism, religious discrimination, and xenophobia in health care,” Dr. Hamilton said. “This curriculum includes courses on health disparities and cultural competencies, launching a lecture series, and other educational components.”
While 2020 has been a trying year, Dr. Hamilton remains hopeful for a prosperous future.
“When I think of the future of hospital medicine, I am hopeful that hospitalists will have a more prominent role in changing the direction of our health care system,” she said. “The pandemic has made the world realize the importance of hospital medicine. We, as hospitalists, are a critical part of its infrastructure and its success.”
If you would like to join Dr. Hamilton and other like-minded hospital medicine leaders in accelerating your career, SHM is currently recruiting for the Fellows and Senior Fellows class of 2021. Applications are open until Nov. 20, 2020. These designations are available across a variety of membership categories, including physicians, nurse practitioners, physician assistants, and qualified practice administrators. Dedicated to promoting excellence, innovation, and quality improvement in patient care, Fellows designations provide members with a distinguishing credential as established pioneers in the industry.
For more information and to review your eligibility, visit hospitalmedicine.org/fellows.
Ms. Cowan is a communications specialist at the Society of Hospital Medicine.
As we navigate a time unlike any other, it is clear that the value hospitalists provide is growing stronger as the hospital medicine field expands. Many Society of Hospital Medicine members look to its Fellows program as a worthwhile opportunity to distinguish themselves as leaders in the field and accelerate their careers in the specialty.
An active member of SHM since 2012 and member of its 2020 class of Fellows, Tanisha Hamilton, MD, FHM, is one of these ambitious individuals.
Dr. Hamilton is based at Baylor University Medical Center in Dallas, an affiliate of Baylor Scott & White Health. Known for personalized health and wellness care, Dr. Hamilton has more than 14 years of experience in the medical field.
Her love for the hospital medicine specialty is rooted in its diversity and complexity of patient cases – something that she knew would innately complement her personality. She says that an invaluable aspect of working in the field is the ability to interact and connect with people from all walks of life.
“My patients keep me motivated in this space. Learning from my patients and having the responsibility of serving as their advocate is incredibly rewarding,” Dr. Hamilton said. “I hope my patients feel like I’ve helped to make a difference in their lives, if only for just a moment.”
When reflecting on why she joined SHM 8 years ago, Dr. Hamilton said she was encouraged to do so because of its like-minded membership community and professional development opportunities, including the Fellows program.
“I applied to SHM’s Fellows program because I’m committed to the specialty. Hospital medicine is an ever-changing field loaded with opportunities to enhance personal and professional career growth,” said Dr. Hamilton. “To me, SHM’s Fellow in Hospital Medicine [FHM] designation demonstrates the ability to make a contribution to the field and to be an instrument for change.”
She credits receiving her designation as a distinction that has opened doors to other career-enhancing opportunities and networking resources, including an expansive global community, program development at her institution, and positions within SHM. Since earning her FHM designation, Dr. Hamilton has become an engaged member of the annual meeting committee and the North Central Texas Chapter.
“Since we are taking our annual conference virtual for SHM Converge in 2021, I’m excited to see how we can transform a meeting of more than 5,000 attendees into a full digital experience with interactive workshops, exhibits, research competitions, and more,” Dr. Hamilton said. “It’s certainly going to be a challenge, but I know that our meetings department and annual conference committee will make it a success!”
As Dr. Hamilton looks forward in her hospital medicine career, she is committed to making a positive impact on the field and for her patients.
In the future, Dr. Hamilton hopes to share curriculum she recently developed and sponsored around diversity, equity, and inclusion with her team at Baylor University Medical Center.
“Following the tragic deaths of numerous individuals, including Breonna Taylor, Ahmaud Abery, and George Floyd, and other people of color who have died because of COVID-19, I have felt compelled to educate my colleagues on how to curtail systemic racism, sexism, religious discrimination, and xenophobia in health care,” Dr. Hamilton said. “This curriculum includes courses on health disparities and cultural competencies, launching a lecture series, and other educational components.”
While 2020 has been a trying year, Dr. Hamilton remains hopeful for a prosperous future.
“When I think of the future of hospital medicine, I am hopeful that hospitalists will have a more prominent role in changing the direction of our health care system,” she said. “The pandemic has made the world realize the importance of hospital medicine. We, as hospitalists, are a critical part of its infrastructure and its success.”
If you would like to join Dr. Hamilton and other like-minded hospital medicine leaders in accelerating your career, SHM is currently recruiting for the Fellows and Senior Fellows class of 2021. Applications are open until Nov. 20, 2020. These designations are available across a variety of membership categories, including physicians, nurse practitioners, physician assistants, and qualified practice administrators. Dedicated to promoting excellence, innovation, and quality improvement in patient care, Fellows designations provide members with a distinguishing credential as established pioneers in the industry.
For more information and to review your eligibility, visit hospitalmedicine.org/fellows.
Ms. Cowan is a communications specialist at the Society of Hospital Medicine.
Low-dose radiotherapy for lung inflammation in severe COVID-19
The first study to suggest benefit from low-dose radiotherapy for severe COVID-19–induced pneumonia involved only 20 patients, but the results were so promising that two larger randomized trials are now underway.
“RESCUE-119 was a trial based on the hypothesis that low-dose radiation therapy may help eliminate the stormy cytokine release and unchecked edema in hospitalized COVID-19 patients,” said Mohammed Khan, MD, PhD, Winship Cancer Institute of Emory University, Atlanta.
“We found patients had a quicker improvement in their time to clinical recovery with low-dose radiation therapy, compared to controls, and this was significant even in this small cohort of patients,” he said.
Dr. Khan was speaking at a special press briefing held during the virtual American Society for Radiation Oncology Annual Meeting 2020.
A total of 20 patients were involved in the trial. Ten patients were treated with low-dose radiotherapy; 10 others, who served as control patients, were treated with the best supportive care and COVID-directed therapies. The control patients were matched for age and comorbidities. All these patients were hospitalized and were oxygen dependent, Dr. Khan noted. In addition, for all patients, serial x-rays demonstrated consolidation and damage in the lung.
The intervention consisted of whole-lung low-dose radiotherapy delivered at a dose of 1.5 Gy.
The first five patients were assessed at an interim endpoint of 7 days to confirm the safety of the procedure. Subsequently, a total of 10 patients were treated with radiotherapy and were followed to day 28.
The main study endpoints were time to clinical recovery, determined on the basis of the patient’s being taken off oxygen, and improvement, evidenced on either serial x-rays or by inflammatory biomarkers.
The median time to clinical recovery was almost three times faster for the patients who received low-dose radiotherapy, at a median of 3 days; for control patients, the median was 12 days (P = .048).
“We also saw a trend toward getting patients out of hospital sooner,” Dr. Khan added. The mean time to hospital discharge was 12 days for the patients who received low-dose radiotherapy, compared with 20 days for control patients (P = .19).
Only one patient required intubation after receiving low-dose radiotherapy, whereas 4 of 10 control patients required some sort of intubation (P = .12), he noted.
Investigators also saw improvements on serial x-rays in 9 of 10 patients treated with low-dose radiotherapy, compared with only 4 patients in the control group. There was also a significant improvement in delirium among the low-dose radiotherapy group compared with control patients (P < .01). Before receiving low-dose radiotherapy, C-reactive protein levels increased by 22% per day. After receiving the 1.5-Gy radiation treatment, there was a sharp reduction in C-reactive protein levels (P < .01) as well as in lactate dehydrogenase levels (P = .03).
Overall survival, however, did not differ between the two treatment groups; 90% of both groups were alive at day 28.
“By focally dampening cytokine hyperactivation, [low-dose radiotherapy] may improve COVID-19 outcomes through immunomodulation,” Dr. Khan explained.
VENTED and PRE-VENT trials
These results from the small RESCUE-119 trial led to the launch of two larger phase 2 trials, the VENTED and the PRE-VENT trials, noted Arnab Chakravarti, MD, professor and chair of radiation oncology, the Ohio State University Comprehensive Cancer Center, Columbus.
To be enrolled in the VENTED trial, patients must have received mechanical ventilation. They will receive at least one dose of ultra-low-dose bilateral whole-lung radiotherapy, with the option of receiving a second dose. The primary objective is 30-day mortality rate.
“The hypothesis is that low-dose thoracic radiation will decrease inflammation and improve outcomes for these intubated COVID-19 patients,” Dr. Chakravarti explained.
The PRE-VENT trial will explore low-dose thoracic radiotherapy for hospitalized patients with severe respiratory compromise who have not yet been intubated. Two doses of low-dose radiotherapy will be tested and compared. The primary study objective is to determine which of the two doses appears to be the most efficacious, Dr. Chakravarti noted.
“The ultimate question to which we remain agnostic is whether the potential benefits of low-dose radiation therapy outweigh the risks,” he said.
Low-dose radiotherapy is readily available in most countries, unlike the newly developed COVID-19 drugs, which are only available in the developed world, he noted. “This creates a bit more economic equity in terms of COVID-19 treatment.”
In addition, it may offer a therapeutic option that could be useful in the future, “as low-dose radiation therapy does not discriminate against various viruses that may cause another pandemic,” he commented. It could offer “a stopgap measure where we don’t have to shut down society completely, which, as we have all witnessed, can cause tremendous financial and social unrest.”
Reasonable question
Whether or not radiotherapy has value for the short-term management of severe pulmonary inflammation caused by COVID-19 is a reasonable question to evaluate in clinical trials, commented discussant Ramesh Rengan, MD, PhD, professor and chair, department of radiation oncology, University of Washington, Seattle.
He noted that inflammatory cells are highly sensitive to radiation, and low-dose radiotherapy has been used effectively in other inflammatory conditions, such as arthritis. Indeed, before the discovery of antibiotics, low-dose radiation was used with reasonable efficacy to treat pneumonia.
“The pneumonia associated with this viral infection is a bit unique in that what happens is the infection triggers an inflammatory cascade – the so-called cytokine storm – that essentially overwhelms the lungs, thereby leading, unfortunately, to mortality,” Dr. Rengan noted. “So a big focus of our energy is how to stop this inflammatory cascade from occurring.”
Corticosteroids are currently the only therapeutic intervention that has shown any mortality benefit in COVID-19, he pointed out.
The question now being asked is: “Can we suppress inflammation specifically within the lung?” Dr. Rengan continued. The main problem with radiotherapy is that it has different effects on various tissues, both immediately and over the long term.
“The immediate benefit that we will likely see from these studies is the immediate sterilization of inflammatory cells,” he said. However, injury to normal lung tissue from low-dose radiotherapy could lead to inflammation weeks or months later, and this could contribute to the disease burden and increase the risk of dying.
Dr. Rengan also noted that there are some very real practical concerns about offering radiotherapy to COVID-19 patients, including potential COVID-19 transmission to vulnerable cancer patients.
Nevertheless, Dr. Rengan said the results to date are very important and that ongoing trials will provide important new information about the long-term impact of this particular treatment in high-risk patients.
“This is a race to the bottom – we are trying to find the lowest possible dose of radiation therapy that we can deliver to sterilize these inflammatory cells without creating any harm to the surrounding tissue,” he said.
“It also brings radiation oncologists into the fight against this deadly disease,” he added.
Dr. Rengan has received honoraria from Novocur and has served as a consultant to AstraZeneca.
A version of this article originally appeared on Medscape.com.
The first study to suggest benefit from low-dose radiotherapy for severe COVID-19–induced pneumonia involved only 20 patients, but the results were so promising that two larger randomized trials are now underway.
“RESCUE-119 was a trial based on the hypothesis that low-dose radiation therapy may help eliminate the stormy cytokine release and unchecked edema in hospitalized COVID-19 patients,” said Mohammed Khan, MD, PhD, Winship Cancer Institute of Emory University, Atlanta.
“We found patients had a quicker improvement in their time to clinical recovery with low-dose radiation therapy, compared to controls, and this was significant even in this small cohort of patients,” he said.
Dr. Khan was speaking at a special press briefing held during the virtual American Society for Radiation Oncology Annual Meeting 2020.
A total of 20 patients were involved in the trial. Ten patients were treated with low-dose radiotherapy; 10 others, who served as control patients, were treated with the best supportive care and COVID-directed therapies. The control patients were matched for age and comorbidities. All these patients were hospitalized and were oxygen dependent, Dr. Khan noted. In addition, for all patients, serial x-rays demonstrated consolidation and damage in the lung.
The intervention consisted of whole-lung low-dose radiotherapy delivered at a dose of 1.5 Gy.
The first five patients were assessed at an interim endpoint of 7 days to confirm the safety of the procedure. Subsequently, a total of 10 patients were treated with radiotherapy and were followed to day 28.
The main study endpoints were time to clinical recovery, determined on the basis of the patient’s being taken off oxygen, and improvement, evidenced on either serial x-rays or by inflammatory biomarkers.
The median time to clinical recovery was almost three times faster for the patients who received low-dose radiotherapy, at a median of 3 days; for control patients, the median was 12 days (P = .048).
“We also saw a trend toward getting patients out of hospital sooner,” Dr. Khan added. The mean time to hospital discharge was 12 days for the patients who received low-dose radiotherapy, compared with 20 days for control patients (P = .19).
Only one patient required intubation after receiving low-dose radiotherapy, whereas 4 of 10 control patients required some sort of intubation (P = .12), he noted.
Investigators also saw improvements on serial x-rays in 9 of 10 patients treated with low-dose radiotherapy, compared with only 4 patients in the control group. There was also a significant improvement in delirium among the low-dose radiotherapy group compared with control patients (P < .01). Before receiving low-dose radiotherapy, C-reactive protein levels increased by 22% per day. After receiving the 1.5-Gy radiation treatment, there was a sharp reduction in C-reactive protein levels (P < .01) as well as in lactate dehydrogenase levels (P = .03).
Overall survival, however, did not differ between the two treatment groups; 90% of both groups were alive at day 28.
“By focally dampening cytokine hyperactivation, [low-dose radiotherapy] may improve COVID-19 outcomes through immunomodulation,” Dr. Khan explained.
VENTED and PRE-VENT trials
These results from the small RESCUE-119 trial led to the launch of two larger phase 2 trials, the VENTED and the PRE-VENT trials, noted Arnab Chakravarti, MD, professor and chair of radiation oncology, the Ohio State University Comprehensive Cancer Center, Columbus.
To be enrolled in the VENTED trial, patients must have received mechanical ventilation. They will receive at least one dose of ultra-low-dose bilateral whole-lung radiotherapy, with the option of receiving a second dose. The primary objective is 30-day mortality rate.
“The hypothesis is that low-dose thoracic radiation will decrease inflammation and improve outcomes for these intubated COVID-19 patients,” Dr. Chakravarti explained.
The PRE-VENT trial will explore low-dose thoracic radiotherapy for hospitalized patients with severe respiratory compromise who have not yet been intubated. Two doses of low-dose radiotherapy will be tested and compared. The primary study objective is to determine which of the two doses appears to be the most efficacious, Dr. Chakravarti noted.
“The ultimate question to which we remain agnostic is whether the potential benefits of low-dose radiation therapy outweigh the risks,” he said.
Low-dose radiotherapy is readily available in most countries, unlike the newly developed COVID-19 drugs, which are only available in the developed world, he noted. “This creates a bit more economic equity in terms of COVID-19 treatment.”
In addition, it may offer a therapeutic option that could be useful in the future, “as low-dose radiation therapy does not discriminate against various viruses that may cause another pandemic,” he commented. It could offer “a stopgap measure where we don’t have to shut down society completely, which, as we have all witnessed, can cause tremendous financial and social unrest.”
Reasonable question
Whether or not radiotherapy has value for the short-term management of severe pulmonary inflammation caused by COVID-19 is a reasonable question to evaluate in clinical trials, commented discussant Ramesh Rengan, MD, PhD, professor and chair, department of radiation oncology, University of Washington, Seattle.
He noted that inflammatory cells are highly sensitive to radiation, and low-dose radiotherapy has been used effectively in other inflammatory conditions, such as arthritis. Indeed, before the discovery of antibiotics, low-dose radiation was used with reasonable efficacy to treat pneumonia.
“The pneumonia associated with this viral infection is a bit unique in that what happens is the infection triggers an inflammatory cascade – the so-called cytokine storm – that essentially overwhelms the lungs, thereby leading, unfortunately, to mortality,” Dr. Rengan noted. “So a big focus of our energy is how to stop this inflammatory cascade from occurring.”
Corticosteroids are currently the only therapeutic intervention that has shown any mortality benefit in COVID-19, he pointed out.
The question now being asked is: “Can we suppress inflammation specifically within the lung?” Dr. Rengan continued. The main problem with radiotherapy is that it has different effects on various tissues, both immediately and over the long term.
“The immediate benefit that we will likely see from these studies is the immediate sterilization of inflammatory cells,” he said. However, injury to normal lung tissue from low-dose radiotherapy could lead to inflammation weeks or months later, and this could contribute to the disease burden and increase the risk of dying.
Dr. Rengan also noted that there are some very real practical concerns about offering radiotherapy to COVID-19 patients, including potential COVID-19 transmission to vulnerable cancer patients.
Nevertheless, Dr. Rengan said the results to date are very important and that ongoing trials will provide important new information about the long-term impact of this particular treatment in high-risk patients.
“This is a race to the bottom – we are trying to find the lowest possible dose of radiation therapy that we can deliver to sterilize these inflammatory cells without creating any harm to the surrounding tissue,” he said.
“It also brings radiation oncologists into the fight against this deadly disease,” he added.
Dr. Rengan has received honoraria from Novocur and has served as a consultant to AstraZeneca.
A version of this article originally appeared on Medscape.com.
The first study to suggest benefit from low-dose radiotherapy for severe COVID-19–induced pneumonia involved only 20 patients, but the results were so promising that two larger randomized trials are now underway.
“RESCUE-119 was a trial based on the hypothesis that low-dose radiation therapy may help eliminate the stormy cytokine release and unchecked edema in hospitalized COVID-19 patients,” said Mohammed Khan, MD, PhD, Winship Cancer Institute of Emory University, Atlanta.
“We found patients had a quicker improvement in their time to clinical recovery with low-dose radiation therapy, compared to controls, and this was significant even in this small cohort of patients,” he said.
Dr. Khan was speaking at a special press briefing held during the virtual American Society for Radiation Oncology Annual Meeting 2020.
A total of 20 patients were involved in the trial. Ten patients were treated with low-dose radiotherapy; 10 others, who served as control patients, were treated with the best supportive care and COVID-directed therapies. The control patients were matched for age and comorbidities. All these patients were hospitalized and were oxygen dependent, Dr. Khan noted. In addition, for all patients, serial x-rays demonstrated consolidation and damage in the lung.
The intervention consisted of whole-lung low-dose radiotherapy delivered at a dose of 1.5 Gy.
The first five patients were assessed at an interim endpoint of 7 days to confirm the safety of the procedure. Subsequently, a total of 10 patients were treated with radiotherapy and were followed to day 28.
The main study endpoints were time to clinical recovery, determined on the basis of the patient’s being taken off oxygen, and improvement, evidenced on either serial x-rays or by inflammatory biomarkers.
The median time to clinical recovery was almost three times faster for the patients who received low-dose radiotherapy, at a median of 3 days; for control patients, the median was 12 days (P = .048).
“We also saw a trend toward getting patients out of hospital sooner,” Dr. Khan added. The mean time to hospital discharge was 12 days for the patients who received low-dose radiotherapy, compared with 20 days for control patients (P = .19).
Only one patient required intubation after receiving low-dose radiotherapy, whereas 4 of 10 control patients required some sort of intubation (P = .12), he noted.
Investigators also saw improvements on serial x-rays in 9 of 10 patients treated with low-dose radiotherapy, compared with only 4 patients in the control group. There was also a significant improvement in delirium among the low-dose radiotherapy group compared with control patients (P < .01). Before receiving low-dose radiotherapy, C-reactive protein levels increased by 22% per day. After receiving the 1.5-Gy radiation treatment, there was a sharp reduction in C-reactive protein levels (P < .01) as well as in lactate dehydrogenase levels (P = .03).
Overall survival, however, did not differ between the two treatment groups; 90% of both groups were alive at day 28.
“By focally dampening cytokine hyperactivation, [low-dose radiotherapy] may improve COVID-19 outcomes through immunomodulation,” Dr. Khan explained.
VENTED and PRE-VENT trials
These results from the small RESCUE-119 trial led to the launch of two larger phase 2 trials, the VENTED and the PRE-VENT trials, noted Arnab Chakravarti, MD, professor and chair of radiation oncology, the Ohio State University Comprehensive Cancer Center, Columbus.
To be enrolled in the VENTED trial, patients must have received mechanical ventilation. They will receive at least one dose of ultra-low-dose bilateral whole-lung radiotherapy, with the option of receiving a second dose. The primary objective is 30-day mortality rate.
“The hypothesis is that low-dose thoracic radiation will decrease inflammation and improve outcomes for these intubated COVID-19 patients,” Dr. Chakravarti explained.
The PRE-VENT trial will explore low-dose thoracic radiotherapy for hospitalized patients with severe respiratory compromise who have not yet been intubated. Two doses of low-dose radiotherapy will be tested and compared. The primary study objective is to determine which of the two doses appears to be the most efficacious, Dr. Chakravarti noted.
“The ultimate question to which we remain agnostic is whether the potential benefits of low-dose radiation therapy outweigh the risks,” he said.
Low-dose radiotherapy is readily available in most countries, unlike the newly developed COVID-19 drugs, which are only available in the developed world, he noted. “This creates a bit more economic equity in terms of COVID-19 treatment.”
In addition, it may offer a therapeutic option that could be useful in the future, “as low-dose radiation therapy does not discriminate against various viruses that may cause another pandemic,” he commented. It could offer “a stopgap measure where we don’t have to shut down society completely, which, as we have all witnessed, can cause tremendous financial and social unrest.”
Reasonable question
Whether or not radiotherapy has value for the short-term management of severe pulmonary inflammation caused by COVID-19 is a reasonable question to evaluate in clinical trials, commented discussant Ramesh Rengan, MD, PhD, professor and chair, department of radiation oncology, University of Washington, Seattle.
He noted that inflammatory cells are highly sensitive to radiation, and low-dose radiotherapy has been used effectively in other inflammatory conditions, such as arthritis. Indeed, before the discovery of antibiotics, low-dose radiation was used with reasonable efficacy to treat pneumonia.
“The pneumonia associated with this viral infection is a bit unique in that what happens is the infection triggers an inflammatory cascade – the so-called cytokine storm – that essentially overwhelms the lungs, thereby leading, unfortunately, to mortality,” Dr. Rengan noted. “So a big focus of our energy is how to stop this inflammatory cascade from occurring.”
Corticosteroids are currently the only therapeutic intervention that has shown any mortality benefit in COVID-19, he pointed out.
The question now being asked is: “Can we suppress inflammation specifically within the lung?” Dr. Rengan continued. The main problem with radiotherapy is that it has different effects on various tissues, both immediately and over the long term.
“The immediate benefit that we will likely see from these studies is the immediate sterilization of inflammatory cells,” he said. However, injury to normal lung tissue from low-dose radiotherapy could lead to inflammation weeks or months later, and this could contribute to the disease burden and increase the risk of dying.
Dr. Rengan also noted that there are some very real practical concerns about offering radiotherapy to COVID-19 patients, including potential COVID-19 transmission to vulnerable cancer patients.
Nevertheless, Dr. Rengan said the results to date are very important and that ongoing trials will provide important new information about the long-term impact of this particular treatment in high-risk patients.
“This is a race to the bottom – we are trying to find the lowest possible dose of radiation therapy that we can deliver to sterilize these inflammatory cells without creating any harm to the surrounding tissue,” he said.
“It also brings radiation oncologists into the fight against this deadly disease,” he added.
Dr. Rengan has received honoraria from Novocur and has served as a consultant to AstraZeneca.
A version of this article originally appeared on Medscape.com.
NfL blood biomarker captures suboptimal treatment response in MS
a new study has shown.
The study found that current serum NfL levels predicted relapses, disability worsening, and MRI activity in the following year independent of standard metrics for treatment monitoring, such as relapse rate, disability worsening, and MRI findings. The biomarker also detected subclinical disease activity in patients with no evidence of disease activity (NEDA3), as measured by absence of previous relapses, worsening score on the Expanded Disability Status Scale (EDSS), or brain lesion formation on MRI.
“Our data in this well-characterized large real-world cohort supports the value of serum NfL levels for treatment monitoring in MS clinical practice,” lead author Özgür Yaldizli, MD, concluded.
Dr. Yaldizli, who is a consultant neurologist at University Hospital Basel (Switzerland), presented the findings at the Joint European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020, this year known as MSVirtual2020.
“This is the first study to compare NfL simultaneously with other markers of disease progression, such as MRI lesions and relapse rate in treated patients. We show that NfL gives a unique signal that is not captured by other markers,” Dr. Yaldizli said.
“This is likely the largest study of NfL in MS to date, with more than 7,000 samples from well-characterized MS patients followed longitudinally for more than 5 years of sampling and including high quality data on MRI and clinical examinations. It is the first time all these factors have been combined so that we can see how NfL compares with other markers of disease progression in predicting clinical events and monitoring treatment efficacy,” said senior author Jens Kuhle, MD, PhD, also from University Hospital Basel.
Large normative database for reference
The researchers also reported a large normative database of NfL values with data from more than 8,000 healthy controls. “This is the largest normative database to date, that gives us reliable reference values for NfL across a range of ages and comorbidities,” Dr. Kuhle noted.
In his presentation, Dr. Yaldizli explained that NfL is a neuronal cytoskeletal protein released into the cerebrospinal fluid and blood following neuroaxonal injury. Although numerous studies have shown that serum NfL is associated with clinical and MRI disease activity and treatment response, it is not clear whether serum NfL under established disease-modifying therapy (DMT) can identify patients with suboptimal treatment response, compared with standard clinical and MRI activity measures.
This study addressed that question in the large real-world Swiss MS cohort.
The study involved 1,366 patients (88.8% with relapsing remitting MS [RRMS], 5.4% with secondary progressive MS, and 5.8% with primary progressive MS) receiving DMT for at least 3 months from seven MS centers. The median disease duration was 7.2 years. Serum NfL was measured every 6 or 12 months with NF-Light assay on the latest-generation HDX platform (blinded for clinical and MRI data). The median follow-up was 4.9 years. There was an average of five samples per patient, with a total of 7462 samples.
Results showed that NfL levels were higher in older patients (14.5% per 10 years), those with secondary progressive MS (12.4% vs. RRMS), those with primary progressive MS (14.4% vs. RRMS), and in those who had a relapse in the last 4 months (53.4%).
NfL levels were 13.4% lower in patients receiving oral DMT (vs. untreated patients) and 17.7% in patients receiving monoclonal antibodies (vs. untreated patients).
In the large cohort of healthy controls, NfL levels also increased with age, but levels in patients with MS were higher than in controls across the whole age spectrum.
To obtain a measure of deviation from normal, the authors converted NfL levels to z score, which express how much (in terms of number of standard deviations) a measurement differs from mean values found in healthy controls of the same age. Effects were more pronounced with use of z score derived from the normative database than with use of absolute NfL levels even after adjustment for age.
In the univariate analysis, serum NfL z score predicted relapse or EDSS worsening in the following year: The higher the z score, the higher the risk for relapse or EDSS worsening. Patients with an NfL z score greater than 1 had a 41% higher risk for relapse or EDSS worsening in the following year, compared with those whose z score was less than 1 (odds ratio, 1.41).
Patients with an NfL z score exceeding 1.5 had an 80% higher risk for relapse or EDSS worsening in the following year than did those whose score was below 1.5 (OR, 1.8).
Patients with an NfL z score greater than 2 had a 2.3 times higher risk for relapse or EDSS worsening in the following year versus those with a score below 2. (P < 0.001 for all comparisons.)
A screen for nervous system conditions?
Dr, Kuhle reported that NfL is being used on an individual basis in clinical practice at present – at certain MS centers. “One of the problems is not having reliable reference values, so this database of normative values will be very helpful in developing those,” he said. “We see an increase in NfL with age in healthy controls. In order to know what pathological levels are, we need to know what normal levels are in controls throughout the spectrum of ages and other comorbidities, which also play a role. If we normalize these, then we can work out the MS signal in a more efficient way.”
Dr. Kuhle believes that, in the future, NfL may be used to screen for nervous system disease. “NfL is a measure of neuronal health independent of MS. If we have increased levels, we should be worried.”
There is a “high level of energy in this field,” he added. “In future, it could be like having a cholesterol test at present – picking up that something is not right and indicating the need for more tests.”
Dr. Yaldizli suggested that NfL monitoring could also help to individualize and optimize use of MS treatments. “There is a huge unmet need in MS. While we have a plethora of treatment options, we are struggling to individualize and monitor treatments. If NfL levels increase, this is likely a strong indication to change treatment even if there are no other overt symptoms.”
Commenting on the current study, ACTRIMS president, Jeffrey Cohen, MD, Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, called it “an important study.”
“NfL clearly can detect disease activity and distinguish efficacy of DMT in groups of patients,” Dr. Cohen said.
“This study shows that NfL can be used to monitor DMT efficacy in individual patients and can detect suboptimal treatment response in patients with NEDA (i.e., who appear stable by the measures we typically employ in practice),” he added.
Dr. Yaldizli sits on advisory boards for Sanofi Genzyme, Novartis, Biogen, and Novartis. Dr. Kuhle reported no relevant disclosures.
This article first appeared on Medscape.com.
a new study has shown.
The study found that current serum NfL levels predicted relapses, disability worsening, and MRI activity in the following year independent of standard metrics for treatment monitoring, such as relapse rate, disability worsening, and MRI findings. The biomarker also detected subclinical disease activity in patients with no evidence of disease activity (NEDA3), as measured by absence of previous relapses, worsening score on the Expanded Disability Status Scale (EDSS), or brain lesion formation on MRI.
“Our data in this well-characterized large real-world cohort supports the value of serum NfL levels for treatment monitoring in MS clinical practice,” lead author Özgür Yaldizli, MD, concluded.
Dr. Yaldizli, who is a consultant neurologist at University Hospital Basel (Switzerland), presented the findings at the Joint European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020, this year known as MSVirtual2020.
“This is the first study to compare NfL simultaneously with other markers of disease progression, such as MRI lesions and relapse rate in treated patients. We show that NfL gives a unique signal that is not captured by other markers,” Dr. Yaldizli said.
“This is likely the largest study of NfL in MS to date, with more than 7,000 samples from well-characterized MS patients followed longitudinally for more than 5 years of sampling and including high quality data on MRI and clinical examinations. It is the first time all these factors have been combined so that we can see how NfL compares with other markers of disease progression in predicting clinical events and monitoring treatment efficacy,” said senior author Jens Kuhle, MD, PhD, also from University Hospital Basel.
Large normative database for reference
The researchers also reported a large normative database of NfL values with data from more than 8,000 healthy controls. “This is the largest normative database to date, that gives us reliable reference values for NfL across a range of ages and comorbidities,” Dr. Kuhle noted.
In his presentation, Dr. Yaldizli explained that NfL is a neuronal cytoskeletal protein released into the cerebrospinal fluid and blood following neuroaxonal injury. Although numerous studies have shown that serum NfL is associated with clinical and MRI disease activity and treatment response, it is not clear whether serum NfL under established disease-modifying therapy (DMT) can identify patients with suboptimal treatment response, compared with standard clinical and MRI activity measures.
This study addressed that question in the large real-world Swiss MS cohort.
The study involved 1,366 patients (88.8% with relapsing remitting MS [RRMS], 5.4% with secondary progressive MS, and 5.8% with primary progressive MS) receiving DMT for at least 3 months from seven MS centers. The median disease duration was 7.2 years. Serum NfL was measured every 6 or 12 months with NF-Light assay on the latest-generation HDX platform (blinded for clinical and MRI data). The median follow-up was 4.9 years. There was an average of five samples per patient, with a total of 7462 samples.
Results showed that NfL levels were higher in older patients (14.5% per 10 years), those with secondary progressive MS (12.4% vs. RRMS), those with primary progressive MS (14.4% vs. RRMS), and in those who had a relapse in the last 4 months (53.4%).
NfL levels were 13.4% lower in patients receiving oral DMT (vs. untreated patients) and 17.7% in patients receiving monoclonal antibodies (vs. untreated patients).
In the large cohort of healthy controls, NfL levels also increased with age, but levels in patients with MS were higher than in controls across the whole age spectrum.
To obtain a measure of deviation from normal, the authors converted NfL levels to z score, which express how much (in terms of number of standard deviations) a measurement differs from mean values found in healthy controls of the same age. Effects were more pronounced with use of z score derived from the normative database than with use of absolute NfL levels even after adjustment for age.
In the univariate analysis, serum NfL z score predicted relapse or EDSS worsening in the following year: The higher the z score, the higher the risk for relapse or EDSS worsening. Patients with an NfL z score greater than 1 had a 41% higher risk for relapse or EDSS worsening in the following year, compared with those whose z score was less than 1 (odds ratio, 1.41).
Patients with an NfL z score exceeding 1.5 had an 80% higher risk for relapse or EDSS worsening in the following year than did those whose score was below 1.5 (OR, 1.8).
Patients with an NfL z score greater than 2 had a 2.3 times higher risk for relapse or EDSS worsening in the following year versus those with a score below 2. (P < 0.001 for all comparisons.)
A screen for nervous system conditions?
Dr, Kuhle reported that NfL is being used on an individual basis in clinical practice at present – at certain MS centers. “One of the problems is not having reliable reference values, so this database of normative values will be very helpful in developing those,” he said. “We see an increase in NfL with age in healthy controls. In order to know what pathological levels are, we need to know what normal levels are in controls throughout the spectrum of ages and other comorbidities, which also play a role. If we normalize these, then we can work out the MS signal in a more efficient way.”
Dr. Kuhle believes that, in the future, NfL may be used to screen for nervous system disease. “NfL is a measure of neuronal health independent of MS. If we have increased levels, we should be worried.”
There is a “high level of energy in this field,” he added. “In future, it could be like having a cholesterol test at present – picking up that something is not right and indicating the need for more tests.”
Dr. Yaldizli suggested that NfL monitoring could also help to individualize and optimize use of MS treatments. “There is a huge unmet need in MS. While we have a plethora of treatment options, we are struggling to individualize and monitor treatments. If NfL levels increase, this is likely a strong indication to change treatment even if there are no other overt symptoms.”
Commenting on the current study, ACTRIMS president, Jeffrey Cohen, MD, Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, called it “an important study.”
“NfL clearly can detect disease activity and distinguish efficacy of DMT in groups of patients,” Dr. Cohen said.
“This study shows that NfL can be used to monitor DMT efficacy in individual patients and can detect suboptimal treatment response in patients with NEDA (i.e., who appear stable by the measures we typically employ in practice),” he added.
Dr. Yaldizli sits on advisory boards for Sanofi Genzyme, Novartis, Biogen, and Novartis. Dr. Kuhle reported no relevant disclosures.
This article first appeared on Medscape.com.
a new study has shown.
The study found that current serum NfL levels predicted relapses, disability worsening, and MRI activity in the following year independent of standard metrics for treatment monitoring, such as relapse rate, disability worsening, and MRI findings. The biomarker also detected subclinical disease activity in patients with no evidence of disease activity (NEDA3), as measured by absence of previous relapses, worsening score on the Expanded Disability Status Scale (EDSS), or brain lesion formation on MRI.
“Our data in this well-characterized large real-world cohort supports the value of serum NfL levels for treatment monitoring in MS clinical practice,” lead author Özgür Yaldizli, MD, concluded.
Dr. Yaldizli, who is a consultant neurologist at University Hospital Basel (Switzerland), presented the findings at the Joint European Committee for Treatment and Research in Multiple Sclerosis–Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS-ACTRIMS) 2020, this year known as MSVirtual2020.
“This is the first study to compare NfL simultaneously with other markers of disease progression, such as MRI lesions and relapse rate in treated patients. We show that NfL gives a unique signal that is not captured by other markers,” Dr. Yaldizli said.
“This is likely the largest study of NfL in MS to date, with more than 7,000 samples from well-characterized MS patients followed longitudinally for more than 5 years of sampling and including high quality data on MRI and clinical examinations. It is the first time all these factors have been combined so that we can see how NfL compares with other markers of disease progression in predicting clinical events and monitoring treatment efficacy,” said senior author Jens Kuhle, MD, PhD, also from University Hospital Basel.
Large normative database for reference
The researchers also reported a large normative database of NfL values with data from more than 8,000 healthy controls. “This is the largest normative database to date, that gives us reliable reference values for NfL across a range of ages and comorbidities,” Dr. Kuhle noted.
In his presentation, Dr. Yaldizli explained that NfL is a neuronal cytoskeletal protein released into the cerebrospinal fluid and blood following neuroaxonal injury. Although numerous studies have shown that serum NfL is associated with clinical and MRI disease activity and treatment response, it is not clear whether serum NfL under established disease-modifying therapy (DMT) can identify patients with suboptimal treatment response, compared with standard clinical and MRI activity measures.
This study addressed that question in the large real-world Swiss MS cohort.
The study involved 1,366 patients (88.8% with relapsing remitting MS [RRMS], 5.4% with secondary progressive MS, and 5.8% with primary progressive MS) receiving DMT for at least 3 months from seven MS centers. The median disease duration was 7.2 years. Serum NfL was measured every 6 or 12 months with NF-Light assay on the latest-generation HDX platform (blinded for clinical and MRI data). The median follow-up was 4.9 years. There was an average of five samples per patient, with a total of 7462 samples.
Results showed that NfL levels were higher in older patients (14.5% per 10 years), those with secondary progressive MS (12.4% vs. RRMS), those with primary progressive MS (14.4% vs. RRMS), and in those who had a relapse in the last 4 months (53.4%).
NfL levels were 13.4% lower in patients receiving oral DMT (vs. untreated patients) and 17.7% in patients receiving monoclonal antibodies (vs. untreated patients).
In the large cohort of healthy controls, NfL levels also increased with age, but levels in patients with MS were higher than in controls across the whole age spectrum.
To obtain a measure of deviation from normal, the authors converted NfL levels to z score, which express how much (in terms of number of standard deviations) a measurement differs from mean values found in healthy controls of the same age. Effects were more pronounced with use of z score derived from the normative database than with use of absolute NfL levels even after adjustment for age.
In the univariate analysis, serum NfL z score predicted relapse or EDSS worsening in the following year: The higher the z score, the higher the risk for relapse or EDSS worsening. Patients with an NfL z score greater than 1 had a 41% higher risk for relapse or EDSS worsening in the following year, compared with those whose z score was less than 1 (odds ratio, 1.41).
Patients with an NfL z score exceeding 1.5 had an 80% higher risk for relapse or EDSS worsening in the following year than did those whose score was below 1.5 (OR, 1.8).
Patients with an NfL z score greater than 2 had a 2.3 times higher risk for relapse or EDSS worsening in the following year versus those with a score below 2. (P < 0.001 for all comparisons.)
A screen for nervous system conditions?
Dr, Kuhle reported that NfL is being used on an individual basis in clinical practice at present – at certain MS centers. “One of the problems is not having reliable reference values, so this database of normative values will be very helpful in developing those,” he said. “We see an increase in NfL with age in healthy controls. In order to know what pathological levels are, we need to know what normal levels are in controls throughout the spectrum of ages and other comorbidities, which also play a role. If we normalize these, then we can work out the MS signal in a more efficient way.”
Dr. Kuhle believes that, in the future, NfL may be used to screen for nervous system disease. “NfL is a measure of neuronal health independent of MS. If we have increased levels, we should be worried.”
There is a “high level of energy in this field,” he added. “In future, it could be like having a cholesterol test at present – picking up that something is not right and indicating the need for more tests.”
Dr. Yaldizli suggested that NfL monitoring could also help to individualize and optimize use of MS treatments. “There is a huge unmet need in MS. While we have a plethora of treatment options, we are struggling to individualize and monitor treatments. If NfL levels increase, this is likely a strong indication to change treatment even if there are no other overt symptoms.”
Commenting on the current study, ACTRIMS president, Jeffrey Cohen, MD, Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, called it “an important study.”
“NfL clearly can detect disease activity and distinguish efficacy of DMT in groups of patients,” Dr. Cohen said.
“This study shows that NfL can be used to monitor DMT efficacy in individual patients and can detect suboptimal treatment response in patients with NEDA (i.e., who appear stable by the measures we typically employ in practice),” he added.
Dr. Yaldizli sits on advisory boards for Sanofi Genzyme, Novartis, Biogen, and Novartis. Dr. Kuhle reported no relevant disclosures.
This article first appeared on Medscape.com.
FROM MSVIRTUAL 2020
Pediatric Procedural Dermatology
Performing dermatologic procedures in infants, children, and teenagers presents many unique challenges. There may be unique diagnoses, different instruments, differences in skin biology, or different approaches to pain management and anesthesia; the inclusion of a third party (caregivers) in decision processes; or a need to assess maturity level or to optimize outcomes over the patient’s lifetime. The field of pediatric procedural dermatology is broad. This article reviews some of the more common procedures performed by pediatric dermatologists and some of the more common ethical and quality-of-life (QOL) considerations one might face in procedural pediatric dermatology. (The textbook Procedural Pediatric Dermatology1 offers a thorough discussion of this topic.)
Quality of Life
More often than not, procedures are performed in pediatric dermatology to improve QOL rather than to prevent morbidity or mortality. In the case of many self-limited conditions, such as ingrown nails or pyogenic granulomas, it is clear that intervention will improve the patient’s QOL. In the case of warts and molluscum contagiosum, emotional, social, and cultural considerations play a large role in determining whether an intervention will improve QOL. Finally, some conditions, such as genodermatoses, giant congenital melanocytic nevi, and large vascular malformations, may be associated with additional systemic symptoms and may not have good treatment options for cure. In these cases, procedural interventions will result in a mixture of positive and negative QOL outcomes that can occur at the same time.
Bemmels et al2 published a qualitative study that provides a good foundation for understanding the positive and negative effects of procedural interventions on children and teenagers. In their study, children and teenagers who underwent reconstructive surgery for craniofacial differences noted improved self-esteem and reduced stigmatization. However, they also experienced negative outcomes, including an addiction to attaining a perfect surgical face, missing school for treatments, difficulty adjusting to an evolving appearance, anxiety related to not knowing when treatments will end, and experiencing stigma related to undergoing surgery.2 Thus, a comprehensive plan for the management of children who need ongoing procedures should include some level of psychosocial support. Two good references on supporting young patients with visible differences include CBT for Appearance Anxiety: Psychosocial Interventions for Anxiety Due to Visible Difference3 and Reaching Teens: Strength-Based, Trauma-Sensitive, Resilience-Building Communication Strategies Rooted in Positive Youth Development.4
Ethics
Ethical decisions in pediatric procedural dermatology differ from adult dermatology in 3 major ways: (1) the involvement of a third party (ie, parents or legal guardians), (2) the need to assess the maturity of the patient, and (3) the need to know local laws in the jurisdiction in which care is being provided. Ethical dilemmas occur when the desires of the child, parents/guardians, and dermatologist are not in alignment. In these cases, it is important to be prepared with a moral or ethical framework to guide decision-making when conflicts occur. Two great resources are the best interest standard5 and the publication entitled, “Informed Consent in Decision-making in Pediatric Practice,” from the American Academy of Pediatrics.6
In pediatrics, it often is better to conceptualize medical decision-making as a combination of informed permission and assent of the patient rather than informed consent. Informed permission describes how a parent or surrogate makes decisions for the child or adolescent and is similar to informed consent. A parent’s informed permission may be in conflict with a child’s wishes, but it is assumed that the parent is acting in the best interest of the child. Assent of the patient is the process of obtaining a minor’s agreement to undergo an intervention even though he/she may lack legal authority or decision-making capacity to provide standard informed consent. It is important to respect the child’s right to assent to interventions to the extent that their maturity level permits to develop trust with the dermatologist and medical encounters in general.
These differences emphasize an active process in which the patient, caregiver, and physician are all involved in the health care process and allow for increasing inclusion of the child as is developmentally appropriate. In the end, however, parents have the legal authority to give or withhold permission for a procedure.7 When this conflicts with a child’s dissent, the dermatologist will need to objectively explore the reasons for the conflict and decide if a procedure is not in the child’s best interests. If a mutual understanding cannot be reached between the dermatologist and parents, obtaining a second opinion is a good option.8
Common Diagnoses
The most common diagnoses unique to procedural pediatric dermatology include congenital melanocytic nevi, vascular anomalies, midline lesions, epidermal nevi, and pilomatricomas. Prior to intervening on these lesions, it is important to consider evaluating for associated diseases.
Congenital Melanocytic Nevi
Nevus Outreach has published best practices for the management of congenital melanocytic nevi.9 In newborns with a congenital melanocytic nevus greater than 3 cm in diameter or more than 20 satellite lesions, it is recommended that magnetic resonance imaging (MRI) of the brain and spine with and without gadolinium contrast be obtained before 6 months of age. Within the first 6 months of life, these children also should see ophthalmologists, neurologists, pediatric dermatologists, and plastic surgeons. These early referrals will help to establish a baseline for the patient and plan for possible interventions, if needed. Additionally, before 3 years of age, every child should be referred to psychology, even if he/she is asymptomatic.10
Vascular Anomalies
Prior to intervening on a vascular anomaly, it is important to accurately classify the lesion. Once the lesion is classified, an evaluation and treatment plan can be developed. The International Society for the Study of Vascular Anomalies has published a detailed classification guide that is a useful starting point in the management of vascular anomalies.11 Once a diagnosis is confirmed, further evaluation may include imaging, specialty referrals, genetic testing, biopsy, or blood tests, and a pediatric dermatologist usually helps to coordinate the care of patients with complex vascular anomalies.
Midline Lesions
Certain lesions in the midline may have a higher risk for neural tube dysraphism, and imaging should be performed prior to any procedural intervention.12 Midline cutaneous findings that are highly likely to be associated with dysraphism are lipomas, acrochordons, pseudotails, true tails, aplasia cutis congenita, congenital scars, dermoid cysts, dermoid sinuses, and infantile hemangiomas that are greater than 2.5 cm in diameter. An MRI should be performed for all high-risk lesions. Intermediate-risk lesions are atypical dimples (>5 mm in diameter or >2.5 cm from the anal verge), hemangiomas less than 2.5 cm in diameter, and hypertrichosis. An ultrasound can screen for spinal dysraphism in these cases as long as imaging is performed prior to 6 months of age. If the child is older than 6 months, an MRI should be performed. Low-risk lesions that do not require imaging are simple dimples, hyperpigmentation, hypopigmentation, melanocytic nevi, port-wine stains, and telangiectases.
Epidermal Nevi
Children with epidermal nevi should have a complete physical examination, focusing on the skeletal system, central nervous system, and eyes. There are no specifically recommended imaging studies or referrals; however, several diagnostic clues can aid in the diagnosis of an epidermal nevus syndrome13:
• Schimmelpenning syndrome: extensive nevus sebaceous and bowing or pain in the legs after 2 years of age
• Phacomatosis pigmentokeratotica: nevus sebaceous and nevus spilus
• Nevus comedonicus syndrome: ipsilateral cataract
• Angora hair nevus syndrome: soft white hair within the nevus
• Becker nevus syndrome: breast hypoplasia
• Proteus syndrome: cerebriform plantar changes
• PIK3CA-related overgrowth spectrum: lipomas, macrodactyly, and/or vascular malformations
• Congenital hemidysplasia with ichthyosiform erythroderma and limb defects: inflammatory epidermal nevi, lateralization, ptychotropism, and ipsilateral limb defects
• Conradi-Hünermann-Happle syndrome: scaly red epidermal nevi without hair follicles and asymmetric limb shortening
Pilomatricomas
In addition to the tent sign—an angulated shape can be appreciated by stretching the skin overlying pilomatricomas—diagnosis of pilomatricoma can be confirmed by transillumination with an otoscope. In this case, a dark shadow typically is cast distal to where the otoscope touches the skin.14 In the case of multiple lesions, the patient should be evaluated for signs of myotonic dystrophy, Turner syndrome, and Gardner syndrome.15
Common Procedures
Pulsed Dye Laser
The pulsed dye laser is the most common laser used for red-colored lesions such as port-wine stains, facial telangiectases, and superficial hemangiomas. It also can be used to treat erythematous scars, verrucae, and psoriasis. In large vascular lesions, it typically is employed at 0.45 to 10 milliseconds every 4 to 6 weeks for 10 or more treatments. Port-wine stains preferably are treated within the first few months of life to provide the most fading without the need for general anesthesia.16 On the other hand, systemic therapy with propranolol is preferred over lasers for infantile hemangiomas.17
Long-Pulsed Alexandrite Laser (755 nm)
The alexandrite laser often is used to treat deeper vascular lesions such as venous lakes and hypertrophic port-wine stains. The operator needs to be cautious, as this laser has a higher incidence of scarring at the settings used to treat vascular lesions (typically fluences around 60–85 J/cm2).18 It also may be used for hair reduction in disorders with hypertrichosis or hidradenitis suppurativa.19
Long-Pulsed Nd:YAG Laser
The long-pulsed Nd:YAG laser also can be used to treat deep vascular lesions and remove unwanted hair. Because of its low window of safety in the treatment of vascular lesions, the alexandrite laser usually is preferred. However, it is the preferred laser for treatment of unwanted hair and hidradenitis suppurativa in darker skin types. It often provides a 50% reduction in hair density after 9 treatments.20
Quality-Switched Lasers
Pigment granules in melanosomes and tattoo particles are targeted with quality-switched (QS) lasers. Typically, a device will contain a combination of QS 532-nm potassium-titanyl-phosphate (KTP) lasers, QS 1064-nm Nd:YAG lasers, and QS 755-nm alexandrite lasers in 1 machine. In general, shorter wavelengths are used to treat epidermal lesions such as ephelides, lentigines, and café-au-lait macules. Longer wavelengths are used to treat deeper lesions such as nevus of Ota. A 2017 review suggested that café-au-lait macules with ragged borders (so-called coast of Maine borders) may respond well to QS lasers.21
Ablative Lasers
The 10,600-nm
Fractionated Lasers
Fractionated lasers can be nonablative (several devices are available in the 1410- to 1927-nm range) or ablative (CO2 or erbium:YAG). In pediatrics, they are usually used to treat burn scars, traumatic scars, and mild to moderate acne scarring.22 The most common side effects from fractionated lasers are prolonged erythema or hyperpigmentation. In addition, it typically takes at least 3 treatments to notice improvements.
Excisions
Pediatric procedural dermatologists remove a variety of unique lesions through excision. A few tips are provided for some of the more common lesions that may be excised in children.
Accessory Tragi
Prior to excising an accessory tragus, the surgeon should consider documenting a facial nerve examination, as accessory tragi can be associated with complete or partial facial nerve dysfunction. Additionally, there usually is an underlying cartilage structure present within the tragus. The cartilage stalk also should be addressed during the excision to avoid a continued palpable deformity after excision.
Dermoid Cysts
Dermoid cysts are the most commonly diagnosed benign orbital lesion in children.23 Exophytic periorbital lesions, which extend outside the orbital rim, can be removed through an infrabrow incision. Endophytic periorbital lesions, which are inside the orbital rim, should be removed through a crease incision. Midline lesions may have an intracranial extension and should be imaged through MRI and/or a computed tomography.24 Because dermoid cysts usually are located below the orbicularis oculi muscle, the muscle should be fixed with a suture prior to closing with skin sutures.
Pilomatricomas
Typically, a linear incision is made overlying the lesion, and then the underlying tumor is removed with sharp or blunt dissection. However, if the overlying skin has been stretched thin, a lenticular excision that includes the thinned skin may improve cosmesis.
Congenital Nevi
Large congenital nevi typically are removed through staged excisions. Lower extremity lesions are best removed before 10 months of age or before walking begins to minimize wound tension. However, if the procedure is not performed in infancy, it is best to wait until walking becomes stable.25 In older children, it is advisable to splint the affected lower extremity for 2 weeks to prevent dehiscence. The interval between excisions typically is 4 to 6 weeks for small lesions and 3 months for larger nevi.
Conclusion
Procedural pediatric dermatology is a broad and emerging field. As this article highlights, children are not small versions of adults and have unique biology, diseases, therapies, social situations, and ethical challenges from adults. This article provides a superficial overview of some of the more common issues faced by pediatric dermatologists and providers who perform procedures on infants, children, and teenagers. Readers who are interested in obtaining a more in-depth understanding of procedural pediatric dermatology should look at Procedural Pediatric Dermatology,1 the first textbook to provide expert opinion and evidence-based information on procedural management of pediatric skin conditions.
- Krakowski AC. Procedural Pediatric Dermatology. Phialdelphia, PA: Wolters Kluwer; 2011.
- Bemmels H, Biesecker B, Schmidt J, et al. Psychological and social factors in undergoing reconstructive surgery among individuals with craniofacial conditions: an exploratory study. Cleft Palate Craniofac J. 2013;50:158-167.
- Clarke A, Thompson AR, Jenkinson E, et al. CBT for Appearance Anxiety: Psychosocial Interventions for Anxiety Due to Visible Difference. Chichester, West Sussex: Wiley-Blackwell; 2013.
- Ginsburg KR, Ramirez McClain ZB, eds. Reaching Teens: Strength-Based, Trauma-Sensitive, Resilience-Building Communication Strategies Rooted in Positive Youth Development. 2nd ed. Itasca, IL: American Academy of Pediatrics; 2020.
- Kopelman LM. The best interests standard for incompetent or incapacitated patients of all ages. J Law Med Ethics. 2007;35:187-196.
- Katz AL, Webb SA; Committee on Bioethics. Informed consent in decision-making in pediatric practice. Pediatrics. 2016;138:e20161485. doi:10.1542/peds.2016-1485.
- Michon K. Emancipation of minors. NOLO website. https://www.nolo.com/legal-encyclopedia/emancipation-of-minors-32237.html. Accessed October 14, 2020.
- Cobb C, Bercovitch L. Ethical dilemmas. In: Krakowski AC, ed. Procedural Pediatric Dermatology. Philadelphia, PA: Wolters Kluwer; 2021:7-10.
- Nevus Outreach, Inc., releases best practice guidelines [news release]. Bartlesville, OK: Nevus Outreach Inc; July 7, 2018. https://www.nevus.org/matrices/page_file_download.php?id=239. Accessed October 14, 2020.
- 10. Masnari O, Neuhaus K, Aegerter T, et al. Predictors of health-related quality of life and psychological adjustment in children and adolescents with congenital melanocytic nevi: analysis of parent reports. J Pediatr Psychol. 2019;44:714-725.
- ISSVA classification for vascular anomalies. International Society for the Study of Vascular Anomalies website. https://www.issva.org/UserFiles/file/ISSVA-Classification-2018.pdf. Approved April 2014. Revised May 2018. Accessed October 14, 2020.
- Sewell MJ, Chiu YE, Drolet BA. Neural tube dysraphism: review of cutaneous markers and imaging. Pediatr Dermatol. 2015;32:161-170.
- Happle R. The group of epidermal nevus syndromes part I. well defined phenotypes. J Am Acad Dermatol. 2010;63:1-22.
- Berreto-Chang OL, Gorell ES, Yamaguma MA, et al. Diagnosis of pilomatricoma using an otoscope. Pediatr Dermatol. 2010;27:554-557.
- Danielson-Cohen A, Lin SJ, Hughes CA, et al. Head and neck pilomatrixoma in children. Arch Otolaryngol Head Neck Surg. 2001;127:1481-1483.
- Jeon H, Bernstein LJ, Belkin DA, et al. Pulsed dye laser treatment of port-wine stains in infancy without the need for general anesthesia. JAMA Dermatol. 2019;155:435-441.
- Krowchuk DP, Frieden IJ, Mancini AJ, et al. Clinical practice guideline for the management of infantile hemangiomas. Pediatrics. 2019;143:e20183475. doi:10.1542/peds.2018-3475.
- Tierney EP, Hanke CW. Alexandrite laser for the treatment of port wine stains refractory to pulsed dye laser. Dermatol Surg. 2011;37:1268-1278.
- Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations. J Am Acad Dermatol. 2019;81:76-90.
- Rao K, Sankar TK. Long-pulsed Nd:YAG laser-assisted hair removal in Fitzpatrick skin types IV-VI. Lasers Med Sci. 2011;26:623-626.
- Belkin DA, Neckman JP, Jeon H, et al. Response to laser treatment of café au lait macules based on morphologic features. JAMA Dermatol. 2017;153:1158-1161.
- Kelly K, Lehmer L. Laser surgery. In: Krakowski AC, ed. Procedural Pediatric Dermatology. Philadelphia, PA: Wolters Kluwer; 2021:92-106.
- Eldesouky MA, Elbakary MA. Orbital dermoid cyst: classification and its impact on surgical management. Semin Ophthalmol. 2018;33:170-174.
- Pryor SG, Lewis JE, Weaver AL, et al. Pediatric dermoid cysts of the head and neck. Otolaryngol Head Neck Surg. 2005;132:938-942.
- Metz BJ. Procedural pediatric dermatology. Dermatol Clin. 2013;31:337-346.
Performing dermatologic procedures in infants, children, and teenagers presents many unique challenges. There may be unique diagnoses, different instruments, differences in skin biology, or different approaches to pain management and anesthesia; the inclusion of a third party (caregivers) in decision processes; or a need to assess maturity level or to optimize outcomes over the patient’s lifetime. The field of pediatric procedural dermatology is broad. This article reviews some of the more common procedures performed by pediatric dermatologists and some of the more common ethical and quality-of-life (QOL) considerations one might face in procedural pediatric dermatology. (The textbook Procedural Pediatric Dermatology1 offers a thorough discussion of this topic.)
Quality of Life
More often than not, procedures are performed in pediatric dermatology to improve QOL rather than to prevent morbidity or mortality. In the case of many self-limited conditions, such as ingrown nails or pyogenic granulomas, it is clear that intervention will improve the patient’s QOL. In the case of warts and molluscum contagiosum, emotional, social, and cultural considerations play a large role in determining whether an intervention will improve QOL. Finally, some conditions, such as genodermatoses, giant congenital melanocytic nevi, and large vascular malformations, may be associated with additional systemic symptoms and may not have good treatment options for cure. In these cases, procedural interventions will result in a mixture of positive and negative QOL outcomes that can occur at the same time.
Bemmels et al2 published a qualitative study that provides a good foundation for understanding the positive and negative effects of procedural interventions on children and teenagers. In their study, children and teenagers who underwent reconstructive surgery for craniofacial differences noted improved self-esteem and reduced stigmatization. However, they also experienced negative outcomes, including an addiction to attaining a perfect surgical face, missing school for treatments, difficulty adjusting to an evolving appearance, anxiety related to not knowing when treatments will end, and experiencing stigma related to undergoing surgery.2 Thus, a comprehensive plan for the management of children who need ongoing procedures should include some level of psychosocial support. Two good references on supporting young patients with visible differences include CBT for Appearance Anxiety: Psychosocial Interventions for Anxiety Due to Visible Difference3 and Reaching Teens: Strength-Based, Trauma-Sensitive, Resilience-Building Communication Strategies Rooted in Positive Youth Development.4
Ethics
Ethical decisions in pediatric procedural dermatology differ from adult dermatology in 3 major ways: (1) the involvement of a third party (ie, parents or legal guardians), (2) the need to assess the maturity of the patient, and (3) the need to know local laws in the jurisdiction in which care is being provided. Ethical dilemmas occur when the desires of the child, parents/guardians, and dermatologist are not in alignment. In these cases, it is important to be prepared with a moral or ethical framework to guide decision-making when conflicts occur. Two great resources are the best interest standard5 and the publication entitled, “Informed Consent in Decision-making in Pediatric Practice,” from the American Academy of Pediatrics.6
In pediatrics, it often is better to conceptualize medical decision-making as a combination of informed permission and assent of the patient rather than informed consent. Informed permission describes how a parent or surrogate makes decisions for the child or adolescent and is similar to informed consent. A parent’s informed permission may be in conflict with a child’s wishes, but it is assumed that the parent is acting in the best interest of the child. Assent of the patient is the process of obtaining a minor’s agreement to undergo an intervention even though he/she may lack legal authority or decision-making capacity to provide standard informed consent. It is important to respect the child’s right to assent to interventions to the extent that their maturity level permits to develop trust with the dermatologist and medical encounters in general.
These differences emphasize an active process in which the patient, caregiver, and physician are all involved in the health care process and allow for increasing inclusion of the child as is developmentally appropriate. In the end, however, parents have the legal authority to give or withhold permission for a procedure.7 When this conflicts with a child’s dissent, the dermatologist will need to objectively explore the reasons for the conflict and decide if a procedure is not in the child’s best interests. If a mutual understanding cannot be reached between the dermatologist and parents, obtaining a second opinion is a good option.8
Common Diagnoses
The most common diagnoses unique to procedural pediatric dermatology include congenital melanocytic nevi, vascular anomalies, midline lesions, epidermal nevi, and pilomatricomas. Prior to intervening on these lesions, it is important to consider evaluating for associated diseases.
Congenital Melanocytic Nevi
Nevus Outreach has published best practices for the management of congenital melanocytic nevi.9 In newborns with a congenital melanocytic nevus greater than 3 cm in diameter or more than 20 satellite lesions, it is recommended that magnetic resonance imaging (MRI) of the brain and spine with and without gadolinium contrast be obtained before 6 months of age. Within the first 6 months of life, these children also should see ophthalmologists, neurologists, pediatric dermatologists, and plastic surgeons. These early referrals will help to establish a baseline for the patient and plan for possible interventions, if needed. Additionally, before 3 years of age, every child should be referred to psychology, even if he/she is asymptomatic.10
Vascular Anomalies
Prior to intervening on a vascular anomaly, it is important to accurately classify the lesion. Once the lesion is classified, an evaluation and treatment plan can be developed. The International Society for the Study of Vascular Anomalies has published a detailed classification guide that is a useful starting point in the management of vascular anomalies.11 Once a diagnosis is confirmed, further evaluation may include imaging, specialty referrals, genetic testing, biopsy, or blood tests, and a pediatric dermatologist usually helps to coordinate the care of patients with complex vascular anomalies.
Midline Lesions
Certain lesions in the midline may have a higher risk for neural tube dysraphism, and imaging should be performed prior to any procedural intervention.12 Midline cutaneous findings that are highly likely to be associated with dysraphism are lipomas, acrochordons, pseudotails, true tails, aplasia cutis congenita, congenital scars, dermoid cysts, dermoid sinuses, and infantile hemangiomas that are greater than 2.5 cm in diameter. An MRI should be performed for all high-risk lesions. Intermediate-risk lesions are atypical dimples (>5 mm in diameter or >2.5 cm from the anal verge), hemangiomas less than 2.5 cm in diameter, and hypertrichosis. An ultrasound can screen for spinal dysraphism in these cases as long as imaging is performed prior to 6 months of age. If the child is older than 6 months, an MRI should be performed. Low-risk lesions that do not require imaging are simple dimples, hyperpigmentation, hypopigmentation, melanocytic nevi, port-wine stains, and telangiectases.
Epidermal Nevi
Children with epidermal nevi should have a complete physical examination, focusing on the skeletal system, central nervous system, and eyes. There are no specifically recommended imaging studies or referrals; however, several diagnostic clues can aid in the diagnosis of an epidermal nevus syndrome13:
• Schimmelpenning syndrome: extensive nevus sebaceous and bowing or pain in the legs after 2 years of age
• Phacomatosis pigmentokeratotica: nevus sebaceous and nevus spilus
• Nevus comedonicus syndrome: ipsilateral cataract
• Angora hair nevus syndrome: soft white hair within the nevus
• Becker nevus syndrome: breast hypoplasia
• Proteus syndrome: cerebriform plantar changes
• PIK3CA-related overgrowth spectrum: lipomas, macrodactyly, and/or vascular malformations
• Congenital hemidysplasia with ichthyosiform erythroderma and limb defects: inflammatory epidermal nevi, lateralization, ptychotropism, and ipsilateral limb defects
• Conradi-Hünermann-Happle syndrome: scaly red epidermal nevi without hair follicles and asymmetric limb shortening
Pilomatricomas
In addition to the tent sign—an angulated shape can be appreciated by stretching the skin overlying pilomatricomas—diagnosis of pilomatricoma can be confirmed by transillumination with an otoscope. In this case, a dark shadow typically is cast distal to where the otoscope touches the skin.14 In the case of multiple lesions, the patient should be evaluated for signs of myotonic dystrophy, Turner syndrome, and Gardner syndrome.15
Common Procedures
Pulsed Dye Laser
The pulsed dye laser is the most common laser used for red-colored lesions such as port-wine stains, facial telangiectases, and superficial hemangiomas. It also can be used to treat erythematous scars, verrucae, and psoriasis. In large vascular lesions, it typically is employed at 0.45 to 10 milliseconds every 4 to 6 weeks for 10 or more treatments. Port-wine stains preferably are treated within the first few months of life to provide the most fading without the need for general anesthesia.16 On the other hand, systemic therapy with propranolol is preferred over lasers for infantile hemangiomas.17
Long-Pulsed Alexandrite Laser (755 nm)
The alexandrite laser often is used to treat deeper vascular lesions such as venous lakes and hypertrophic port-wine stains. The operator needs to be cautious, as this laser has a higher incidence of scarring at the settings used to treat vascular lesions (typically fluences around 60–85 J/cm2).18 It also may be used for hair reduction in disorders with hypertrichosis or hidradenitis suppurativa.19
Long-Pulsed Nd:YAG Laser
The long-pulsed Nd:YAG laser also can be used to treat deep vascular lesions and remove unwanted hair. Because of its low window of safety in the treatment of vascular lesions, the alexandrite laser usually is preferred. However, it is the preferred laser for treatment of unwanted hair and hidradenitis suppurativa in darker skin types. It often provides a 50% reduction in hair density after 9 treatments.20
Quality-Switched Lasers
Pigment granules in melanosomes and tattoo particles are targeted with quality-switched (QS) lasers. Typically, a device will contain a combination of QS 532-nm potassium-titanyl-phosphate (KTP) lasers, QS 1064-nm Nd:YAG lasers, and QS 755-nm alexandrite lasers in 1 machine. In general, shorter wavelengths are used to treat epidermal lesions such as ephelides, lentigines, and café-au-lait macules. Longer wavelengths are used to treat deeper lesions such as nevus of Ota. A 2017 review suggested that café-au-lait macules with ragged borders (so-called coast of Maine borders) may respond well to QS lasers.21
Ablative Lasers
The 10,600-nm
Fractionated Lasers
Fractionated lasers can be nonablative (several devices are available in the 1410- to 1927-nm range) or ablative (CO2 or erbium:YAG). In pediatrics, they are usually used to treat burn scars, traumatic scars, and mild to moderate acne scarring.22 The most common side effects from fractionated lasers are prolonged erythema or hyperpigmentation. In addition, it typically takes at least 3 treatments to notice improvements.
Excisions
Pediatric procedural dermatologists remove a variety of unique lesions through excision. A few tips are provided for some of the more common lesions that may be excised in children.
Accessory Tragi
Prior to excising an accessory tragus, the surgeon should consider documenting a facial nerve examination, as accessory tragi can be associated with complete or partial facial nerve dysfunction. Additionally, there usually is an underlying cartilage structure present within the tragus. The cartilage stalk also should be addressed during the excision to avoid a continued palpable deformity after excision.
Dermoid Cysts
Dermoid cysts are the most commonly diagnosed benign orbital lesion in children.23 Exophytic periorbital lesions, which extend outside the orbital rim, can be removed through an infrabrow incision. Endophytic periorbital lesions, which are inside the orbital rim, should be removed through a crease incision. Midline lesions may have an intracranial extension and should be imaged through MRI and/or a computed tomography.24 Because dermoid cysts usually are located below the orbicularis oculi muscle, the muscle should be fixed with a suture prior to closing with skin sutures.
Pilomatricomas
Typically, a linear incision is made overlying the lesion, and then the underlying tumor is removed with sharp or blunt dissection. However, if the overlying skin has been stretched thin, a lenticular excision that includes the thinned skin may improve cosmesis.
Congenital Nevi
Large congenital nevi typically are removed through staged excisions. Lower extremity lesions are best removed before 10 months of age or before walking begins to minimize wound tension. However, if the procedure is not performed in infancy, it is best to wait until walking becomes stable.25 In older children, it is advisable to splint the affected lower extremity for 2 weeks to prevent dehiscence. The interval between excisions typically is 4 to 6 weeks for small lesions and 3 months for larger nevi.
Conclusion
Procedural pediatric dermatology is a broad and emerging field. As this article highlights, children are not small versions of adults and have unique biology, diseases, therapies, social situations, and ethical challenges from adults. This article provides a superficial overview of some of the more common issues faced by pediatric dermatologists and providers who perform procedures on infants, children, and teenagers. Readers who are interested in obtaining a more in-depth understanding of procedural pediatric dermatology should look at Procedural Pediatric Dermatology,1 the first textbook to provide expert opinion and evidence-based information on procedural management of pediatric skin conditions.
Performing dermatologic procedures in infants, children, and teenagers presents many unique challenges. There may be unique diagnoses, different instruments, differences in skin biology, or different approaches to pain management and anesthesia; the inclusion of a third party (caregivers) in decision processes; or a need to assess maturity level or to optimize outcomes over the patient’s lifetime. The field of pediatric procedural dermatology is broad. This article reviews some of the more common procedures performed by pediatric dermatologists and some of the more common ethical and quality-of-life (QOL) considerations one might face in procedural pediatric dermatology. (The textbook Procedural Pediatric Dermatology1 offers a thorough discussion of this topic.)
Quality of Life
More often than not, procedures are performed in pediatric dermatology to improve QOL rather than to prevent morbidity or mortality. In the case of many self-limited conditions, such as ingrown nails or pyogenic granulomas, it is clear that intervention will improve the patient’s QOL. In the case of warts and molluscum contagiosum, emotional, social, and cultural considerations play a large role in determining whether an intervention will improve QOL. Finally, some conditions, such as genodermatoses, giant congenital melanocytic nevi, and large vascular malformations, may be associated with additional systemic symptoms and may not have good treatment options for cure. In these cases, procedural interventions will result in a mixture of positive and negative QOL outcomes that can occur at the same time.
Bemmels et al2 published a qualitative study that provides a good foundation for understanding the positive and negative effects of procedural interventions on children and teenagers. In their study, children and teenagers who underwent reconstructive surgery for craniofacial differences noted improved self-esteem and reduced stigmatization. However, they also experienced negative outcomes, including an addiction to attaining a perfect surgical face, missing school for treatments, difficulty adjusting to an evolving appearance, anxiety related to not knowing when treatments will end, and experiencing stigma related to undergoing surgery.2 Thus, a comprehensive plan for the management of children who need ongoing procedures should include some level of psychosocial support. Two good references on supporting young patients with visible differences include CBT for Appearance Anxiety: Psychosocial Interventions for Anxiety Due to Visible Difference3 and Reaching Teens: Strength-Based, Trauma-Sensitive, Resilience-Building Communication Strategies Rooted in Positive Youth Development.4
Ethics
Ethical decisions in pediatric procedural dermatology differ from adult dermatology in 3 major ways: (1) the involvement of a third party (ie, parents or legal guardians), (2) the need to assess the maturity of the patient, and (3) the need to know local laws in the jurisdiction in which care is being provided. Ethical dilemmas occur when the desires of the child, parents/guardians, and dermatologist are not in alignment. In these cases, it is important to be prepared with a moral or ethical framework to guide decision-making when conflicts occur. Two great resources are the best interest standard5 and the publication entitled, “Informed Consent in Decision-making in Pediatric Practice,” from the American Academy of Pediatrics.6
In pediatrics, it often is better to conceptualize medical decision-making as a combination of informed permission and assent of the patient rather than informed consent. Informed permission describes how a parent or surrogate makes decisions for the child or adolescent and is similar to informed consent. A parent’s informed permission may be in conflict with a child’s wishes, but it is assumed that the parent is acting in the best interest of the child. Assent of the patient is the process of obtaining a minor’s agreement to undergo an intervention even though he/she may lack legal authority or decision-making capacity to provide standard informed consent. It is important to respect the child’s right to assent to interventions to the extent that their maturity level permits to develop trust with the dermatologist and medical encounters in general.
These differences emphasize an active process in which the patient, caregiver, and physician are all involved in the health care process and allow for increasing inclusion of the child as is developmentally appropriate. In the end, however, parents have the legal authority to give or withhold permission for a procedure.7 When this conflicts with a child’s dissent, the dermatologist will need to objectively explore the reasons for the conflict and decide if a procedure is not in the child’s best interests. If a mutual understanding cannot be reached between the dermatologist and parents, obtaining a second opinion is a good option.8
Common Diagnoses
The most common diagnoses unique to procedural pediatric dermatology include congenital melanocytic nevi, vascular anomalies, midline lesions, epidermal nevi, and pilomatricomas. Prior to intervening on these lesions, it is important to consider evaluating for associated diseases.
Congenital Melanocytic Nevi
Nevus Outreach has published best practices for the management of congenital melanocytic nevi.9 In newborns with a congenital melanocytic nevus greater than 3 cm in diameter or more than 20 satellite lesions, it is recommended that magnetic resonance imaging (MRI) of the brain and spine with and without gadolinium contrast be obtained before 6 months of age. Within the first 6 months of life, these children also should see ophthalmologists, neurologists, pediatric dermatologists, and plastic surgeons. These early referrals will help to establish a baseline for the patient and plan for possible interventions, if needed. Additionally, before 3 years of age, every child should be referred to psychology, even if he/she is asymptomatic.10
Vascular Anomalies
Prior to intervening on a vascular anomaly, it is important to accurately classify the lesion. Once the lesion is classified, an evaluation and treatment plan can be developed. The International Society for the Study of Vascular Anomalies has published a detailed classification guide that is a useful starting point in the management of vascular anomalies.11 Once a diagnosis is confirmed, further evaluation may include imaging, specialty referrals, genetic testing, biopsy, or blood tests, and a pediatric dermatologist usually helps to coordinate the care of patients with complex vascular anomalies.
Midline Lesions
Certain lesions in the midline may have a higher risk for neural tube dysraphism, and imaging should be performed prior to any procedural intervention.12 Midline cutaneous findings that are highly likely to be associated with dysraphism are lipomas, acrochordons, pseudotails, true tails, aplasia cutis congenita, congenital scars, dermoid cysts, dermoid sinuses, and infantile hemangiomas that are greater than 2.5 cm in diameter. An MRI should be performed for all high-risk lesions. Intermediate-risk lesions are atypical dimples (>5 mm in diameter or >2.5 cm from the anal verge), hemangiomas less than 2.5 cm in diameter, and hypertrichosis. An ultrasound can screen for spinal dysraphism in these cases as long as imaging is performed prior to 6 months of age. If the child is older than 6 months, an MRI should be performed. Low-risk lesions that do not require imaging are simple dimples, hyperpigmentation, hypopigmentation, melanocytic nevi, port-wine stains, and telangiectases.
Epidermal Nevi
Children with epidermal nevi should have a complete physical examination, focusing on the skeletal system, central nervous system, and eyes. There are no specifically recommended imaging studies or referrals; however, several diagnostic clues can aid in the diagnosis of an epidermal nevus syndrome13:
• Schimmelpenning syndrome: extensive nevus sebaceous and bowing or pain in the legs after 2 years of age
• Phacomatosis pigmentokeratotica: nevus sebaceous and nevus spilus
• Nevus comedonicus syndrome: ipsilateral cataract
• Angora hair nevus syndrome: soft white hair within the nevus
• Becker nevus syndrome: breast hypoplasia
• Proteus syndrome: cerebriform plantar changes
• PIK3CA-related overgrowth spectrum: lipomas, macrodactyly, and/or vascular malformations
• Congenital hemidysplasia with ichthyosiform erythroderma and limb defects: inflammatory epidermal nevi, lateralization, ptychotropism, and ipsilateral limb defects
• Conradi-Hünermann-Happle syndrome: scaly red epidermal nevi without hair follicles and asymmetric limb shortening
Pilomatricomas
In addition to the tent sign—an angulated shape can be appreciated by stretching the skin overlying pilomatricomas—diagnosis of pilomatricoma can be confirmed by transillumination with an otoscope. In this case, a dark shadow typically is cast distal to where the otoscope touches the skin.14 In the case of multiple lesions, the patient should be evaluated for signs of myotonic dystrophy, Turner syndrome, and Gardner syndrome.15
Common Procedures
Pulsed Dye Laser
The pulsed dye laser is the most common laser used for red-colored lesions such as port-wine stains, facial telangiectases, and superficial hemangiomas. It also can be used to treat erythematous scars, verrucae, and psoriasis. In large vascular lesions, it typically is employed at 0.45 to 10 milliseconds every 4 to 6 weeks for 10 or more treatments. Port-wine stains preferably are treated within the first few months of life to provide the most fading without the need for general anesthesia.16 On the other hand, systemic therapy with propranolol is preferred over lasers for infantile hemangiomas.17
Long-Pulsed Alexandrite Laser (755 nm)
The alexandrite laser often is used to treat deeper vascular lesions such as venous lakes and hypertrophic port-wine stains. The operator needs to be cautious, as this laser has a higher incidence of scarring at the settings used to treat vascular lesions (typically fluences around 60–85 J/cm2).18 It also may be used for hair reduction in disorders with hypertrichosis or hidradenitis suppurativa.19
Long-Pulsed Nd:YAG Laser
The long-pulsed Nd:YAG laser also can be used to treat deep vascular lesions and remove unwanted hair. Because of its low window of safety in the treatment of vascular lesions, the alexandrite laser usually is preferred. However, it is the preferred laser for treatment of unwanted hair and hidradenitis suppurativa in darker skin types. It often provides a 50% reduction in hair density after 9 treatments.20
Quality-Switched Lasers
Pigment granules in melanosomes and tattoo particles are targeted with quality-switched (QS) lasers. Typically, a device will contain a combination of QS 532-nm potassium-titanyl-phosphate (KTP) lasers, QS 1064-nm Nd:YAG lasers, and QS 755-nm alexandrite lasers in 1 machine. In general, shorter wavelengths are used to treat epidermal lesions such as ephelides, lentigines, and café-au-lait macules. Longer wavelengths are used to treat deeper lesions such as nevus of Ota. A 2017 review suggested that café-au-lait macules with ragged borders (so-called coast of Maine borders) may respond well to QS lasers.21
Ablative Lasers
The 10,600-nm
Fractionated Lasers
Fractionated lasers can be nonablative (several devices are available in the 1410- to 1927-nm range) or ablative (CO2 or erbium:YAG). In pediatrics, they are usually used to treat burn scars, traumatic scars, and mild to moderate acne scarring.22 The most common side effects from fractionated lasers are prolonged erythema or hyperpigmentation. In addition, it typically takes at least 3 treatments to notice improvements.
Excisions
Pediatric procedural dermatologists remove a variety of unique lesions through excision. A few tips are provided for some of the more common lesions that may be excised in children.
Accessory Tragi
Prior to excising an accessory tragus, the surgeon should consider documenting a facial nerve examination, as accessory tragi can be associated with complete or partial facial nerve dysfunction. Additionally, there usually is an underlying cartilage structure present within the tragus. The cartilage stalk also should be addressed during the excision to avoid a continued palpable deformity after excision.
Dermoid Cysts
Dermoid cysts are the most commonly diagnosed benign orbital lesion in children.23 Exophytic periorbital lesions, which extend outside the orbital rim, can be removed through an infrabrow incision. Endophytic periorbital lesions, which are inside the orbital rim, should be removed through a crease incision. Midline lesions may have an intracranial extension and should be imaged through MRI and/or a computed tomography.24 Because dermoid cysts usually are located below the orbicularis oculi muscle, the muscle should be fixed with a suture prior to closing with skin sutures.
Pilomatricomas
Typically, a linear incision is made overlying the lesion, and then the underlying tumor is removed with sharp or blunt dissection. However, if the overlying skin has been stretched thin, a lenticular excision that includes the thinned skin may improve cosmesis.
Congenital Nevi
Large congenital nevi typically are removed through staged excisions. Lower extremity lesions are best removed before 10 months of age or before walking begins to minimize wound tension. However, if the procedure is not performed in infancy, it is best to wait until walking becomes stable.25 In older children, it is advisable to splint the affected lower extremity for 2 weeks to prevent dehiscence. The interval between excisions typically is 4 to 6 weeks for small lesions and 3 months for larger nevi.
Conclusion
Procedural pediatric dermatology is a broad and emerging field. As this article highlights, children are not small versions of adults and have unique biology, diseases, therapies, social situations, and ethical challenges from adults. This article provides a superficial overview of some of the more common issues faced by pediatric dermatologists and providers who perform procedures on infants, children, and teenagers. Readers who are interested in obtaining a more in-depth understanding of procedural pediatric dermatology should look at Procedural Pediatric Dermatology,1 the first textbook to provide expert opinion and evidence-based information on procedural management of pediatric skin conditions.
- Krakowski AC. Procedural Pediatric Dermatology. Phialdelphia, PA: Wolters Kluwer; 2011.
- Bemmels H, Biesecker B, Schmidt J, et al. Psychological and social factors in undergoing reconstructive surgery among individuals with craniofacial conditions: an exploratory study. Cleft Palate Craniofac J. 2013;50:158-167.
- Clarke A, Thompson AR, Jenkinson E, et al. CBT for Appearance Anxiety: Psychosocial Interventions for Anxiety Due to Visible Difference. Chichester, West Sussex: Wiley-Blackwell; 2013.
- Ginsburg KR, Ramirez McClain ZB, eds. Reaching Teens: Strength-Based, Trauma-Sensitive, Resilience-Building Communication Strategies Rooted in Positive Youth Development. 2nd ed. Itasca, IL: American Academy of Pediatrics; 2020.
- Kopelman LM. The best interests standard for incompetent or incapacitated patients of all ages. J Law Med Ethics. 2007;35:187-196.
- Katz AL, Webb SA; Committee on Bioethics. Informed consent in decision-making in pediatric practice. Pediatrics. 2016;138:e20161485. doi:10.1542/peds.2016-1485.
- Michon K. Emancipation of minors. NOLO website. https://www.nolo.com/legal-encyclopedia/emancipation-of-minors-32237.html. Accessed October 14, 2020.
- Cobb C, Bercovitch L. Ethical dilemmas. In: Krakowski AC, ed. Procedural Pediatric Dermatology. Philadelphia, PA: Wolters Kluwer; 2021:7-10.
- Nevus Outreach, Inc., releases best practice guidelines [news release]. Bartlesville, OK: Nevus Outreach Inc; July 7, 2018. https://www.nevus.org/matrices/page_file_download.php?id=239. Accessed October 14, 2020.
- 10. Masnari O, Neuhaus K, Aegerter T, et al. Predictors of health-related quality of life and psychological adjustment in children and adolescents with congenital melanocytic nevi: analysis of parent reports. J Pediatr Psychol. 2019;44:714-725.
- ISSVA classification for vascular anomalies. International Society for the Study of Vascular Anomalies website. https://www.issva.org/UserFiles/file/ISSVA-Classification-2018.pdf. Approved April 2014. Revised May 2018. Accessed October 14, 2020.
- Sewell MJ, Chiu YE, Drolet BA. Neural tube dysraphism: review of cutaneous markers and imaging. Pediatr Dermatol. 2015;32:161-170.
- Happle R. The group of epidermal nevus syndromes part I. well defined phenotypes. J Am Acad Dermatol. 2010;63:1-22.
- Berreto-Chang OL, Gorell ES, Yamaguma MA, et al. Diagnosis of pilomatricoma using an otoscope. Pediatr Dermatol. 2010;27:554-557.
- Danielson-Cohen A, Lin SJ, Hughes CA, et al. Head and neck pilomatrixoma in children. Arch Otolaryngol Head Neck Surg. 2001;127:1481-1483.
- Jeon H, Bernstein LJ, Belkin DA, et al. Pulsed dye laser treatment of port-wine stains in infancy without the need for general anesthesia. JAMA Dermatol. 2019;155:435-441.
- Krowchuk DP, Frieden IJ, Mancini AJ, et al. Clinical practice guideline for the management of infantile hemangiomas. Pediatrics. 2019;143:e20183475. doi:10.1542/peds.2018-3475.
- Tierney EP, Hanke CW. Alexandrite laser for the treatment of port wine stains refractory to pulsed dye laser. Dermatol Surg. 2011;37:1268-1278.
- Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations. J Am Acad Dermatol. 2019;81:76-90.
- Rao K, Sankar TK. Long-pulsed Nd:YAG laser-assisted hair removal in Fitzpatrick skin types IV-VI. Lasers Med Sci. 2011;26:623-626.
- Belkin DA, Neckman JP, Jeon H, et al. Response to laser treatment of café au lait macules based on morphologic features. JAMA Dermatol. 2017;153:1158-1161.
- Kelly K, Lehmer L. Laser surgery. In: Krakowski AC, ed. Procedural Pediatric Dermatology. Philadelphia, PA: Wolters Kluwer; 2021:92-106.
- Eldesouky MA, Elbakary MA. Orbital dermoid cyst: classification and its impact on surgical management. Semin Ophthalmol. 2018;33:170-174.
- Pryor SG, Lewis JE, Weaver AL, et al. Pediatric dermoid cysts of the head and neck. Otolaryngol Head Neck Surg. 2005;132:938-942.
- Metz BJ. Procedural pediatric dermatology. Dermatol Clin. 2013;31:337-346.
- Krakowski AC. Procedural Pediatric Dermatology. Phialdelphia, PA: Wolters Kluwer; 2011.
- Bemmels H, Biesecker B, Schmidt J, et al. Psychological and social factors in undergoing reconstructive surgery among individuals with craniofacial conditions: an exploratory study. Cleft Palate Craniofac J. 2013;50:158-167.
- Clarke A, Thompson AR, Jenkinson E, et al. CBT for Appearance Anxiety: Psychosocial Interventions for Anxiety Due to Visible Difference. Chichester, West Sussex: Wiley-Blackwell; 2013.
- Ginsburg KR, Ramirez McClain ZB, eds. Reaching Teens: Strength-Based, Trauma-Sensitive, Resilience-Building Communication Strategies Rooted in Positive Youth Development. 2nd ed. Itasca, IL: American Academy of Pediatrics; 2020.
- Kopelman LM. The best interests standard for incompetent or incapacitated patients of all ages. J Law Med Ethics. 2007;35:187-196.
- Katz AL, Webb SA; Committee on Bioethics. Informed consent in decision-making in pediatric practice. Pediatrics. 2016;138:e20161485. doi:10.1542/peds.2016-1485.
- Michon K. Emancipation of minors. NOLO website. https://www.nolo.com/legal-encyclopedia/emancipation-of-minors-32237.html. Accessed October 14, 2020.
- Cobb C, Bercovitch L. Ethical dilemmas. In: Krakowski AC, ed. Procedural Pediatric Dermatology. Philadelphia, PA: Wolters Kluwer; 2021:7-10.
- Nevus Outreach, Inc., releases best practice guidelines [news release]. Bartlesville, OK: Nevus Outreach Inc; July 7, 2018. https://www.nevus.org/matrices/page_file_download.php?id=239. Accessed October 14, 2020.
- 10. Masnari O, Neuhaus K, Aegerter T, et al. Predictors of health-related quality of life and psychological adjustment in children and adolescents with congenital melanocytic nevi: analysis of parent reports. J Pediatr Psychol. 2019;44:714-725.
- ISSVA classification for vascular anomalies. International Society for the Study of Vascular Anomalies website. https://www.issva.org/UserFiles/file/ISSVA-Classification-2018.pdf. Approved April 2014. Revised May 2018. Accessed October 14, 2020.
- Sewell MJ, Chiu YE, Drolet BA. Neural tube dysraphism: review of cutaneous markers and imaging. Pediatr Dermatol. 2015;32:161-170.
- Happle R. The group of epidermal nevus syndromes part I. well defined phenotypes. J Am Acad Dermatol. 2010;63:1-22.
- Berreto-Chang OL, Gorell ES, Yamaguma MA, et al. Diagnosis of pilomatricoma using an otoscope. Pediatr Dermatol. 2010;27:554-557.
- Danielson-Cohen A, Lin SJ, Hughes CA, et al. Head and neck pilomatrixoma in children. Arch Otolaryngol Head Neck Surg. 2001;127:1481-1483.
- Jeon H, Bernstein LJ, Belkin DA, et al. Pulsed dye laser treatment of port-wine stains in infancy without the need for general anesthesia. JAMA Dermatol. 2019;155:435-441.
- Krowchuk DP, Frieden IJ, Mancini AJ, et al. Clinical practice guideline for the management of infantile hemangiomas. Pediatrics. 2019;143:e20183475. doi:10.1542/peds.2018-3475.
- Tierney EP, Hanke CW. Alexandrite laser for the treatment of port wine stains refractory to pulsed dye laser. Dermatol Surg. 2011;37:1268-1278.
- Alikhan A, Sayed C, Alavi A, et al. North American clinical management guidelines for hidradenitis suppurativa: a publication from the United States and Canadian Hidradenitis Suppurativa Foundations. J Am Acad Dermatol. 2019;81:76-90.
- Rao K, Sankar TK. Long-pulsed Nd:YAG laser-assisted hair removal in Fitzpatrick skin types IV-VI. Lasers Med Sci. 2011;26:623-626.
- Belkin DA, Neckman JP, Jeon H, et al. Response to laser treatment of café au lait macules based on morphologic features. JAMA Dermatol. 2017;153:1158-1161.
- Kelly K, Lehmer L. Laser surgery. In: Krakowski AC, ed. Procedural Pediatric Dermatology. Philadelphia, PA: Wolters Kluwer; 2021:92-106.
- Eldesouky MA, Elbakary MA. Orbital dermoid cyst: classification and its impact on surgical management. Semin Ophthalmol. 2018;33:170-174.
- Pryor SG, Lewis JE, Weaver AL, et al. Pediatric dermoid cysts of the head and neck. Otolaryngol Head Neck Surg. 2005;132:938-942.
- Metz BJ. Procedural pediatric dermatology. Dermatol Clin. 2013;31:337-346.
Practice Points
- Children who require repetitive laser or surgical procedures over time benefit from regular monitoring of psychosocial needs.
- The informed consent process for children differs from adult procedural dermatology and should be adjusted to the maturity level of the patient.
- Common diagnoses unique to procedural pediatric dermatology that may require additional investigation include congenital melanocytic nevi, vascular anomalies, epidermal nevi, and midline lesions.
- Specific measures can be performed to improve outcomes when removing accessory tragi, dermoid cysts, pilomatricomas, and congenital nevi.
Are HMAS appropriate for posttransplant maintenance in acute leukemias?
Hematopoietic stem cell transplantation (HCT) is one of the most important treatment options for acute leukemias. However, posttransplant cancer recurrence remains a continuing issue. And while there are reasons to think that hypomethylating agents (HMAS) could be helpful as maintenance tools to prevent cancer recurrence after HCT in leukemia, a hematologist/oncologist told colleagues that the treatment isn’t yet ready for prime time.
“I don’t think you can prefer hypomethylating agents over anything right now. Unfortunately, there’s no data that we can hang our hat on that says they are of benefit in the posttransplant setting,” said Frederick Appelbaum, MD, executive vice president and deputy director of the Fred Hutchinson Cancer Research Center, Seattle, in a presentation at the virtual Acute Leukemia Forum of Hemedicus.
However, there’s still plenty of room for improvement for patients following HCT, he said, pointing to the findings of a 2020 study. The report, which he cowrote, found that 200-day mortality after HCT fell by a third from 2003-2007 to 2013-20017, but also noted that “relapse of cancer remains the largest obstacle to better survival outcomes.”
Dr. Appelbaum described the findings this way: “Without a doubt, the major limitation to transplants for hematologic malignancies today is disease recurrence,” he said. “In fact, if you look at patients after day 100, over 60% of the reason for failure is tumor regrowth. Thus, people are very anxious to look at any method that we can to prevent posttransplant relapse, including the use of hypomethylating agents.”
In regard to strategy, “we don’t have to get rid of every last leukemic cell. Just delaying recurrence might be enough,” he said. “If you can keep the patient from relapsing for the first 3 months, and then take the brakes off the immune suppression and allow immunity to regrow, that may be enough to allow increased numbers of patients to be cured of their disease.”
A potential role
Why might HMAS be a possible option after transplant? They do appear to play a role after chemotherapy, he said, pointing to four 2019 studies: One that examined decitabine and three that examined azacytidine: Here, here, and here.
“These four studies provide convincing evidence that hypomethylating-agent therapy after conventional chemotherapy may either prevent or delay relapse when given as maintenance,” Dr. Appelbaum said.
If HMAS work after standard chemotherapy, why might they fail to work after transplantation? “For one, by the time the disease has been able to go through chemotherapy and transplant, you’re left with highly resistant cells,” he said. “Therefore, hypomethylating agents may not be enough to get rid of the disease. Secondly, any of you who have tried to give a maintenance therapy after transplantation know how difficult it can be with CMV [cytomegalovirus] reactivation, count suppression with ganciclovir, graft-versus-host disease [GVHD] causing nausea and vomiting, diarrhea and renal dysfunction caused by calcineurin inhibitors. These are daily events during the first 3 months after transplantation, making drug administration difficult.”
In addition, he said, “even if you can give the drug, the clinical and disease variability may make it very difficult to detect an effect.”
In another study, researchers “did make a valiant attempt to study azacitidine in the posttransplant setting by randomizing 181 patients to either azacitidine or observation,” Dr. Appelbaum said. “Unfortunately, as they reported in 2018, they could not detect a difference in either disease-free or overall survival.”
The researchers reported that nearly 75% of patients in the azacitidine arm failed to complete the planned 12 cycles of treatment, he said. “The reasons for stopping the drug were pretty profound. Half of the patients stopped because they relapsed. Others had stopped because of grades three or four toxicity, death, or severe GVHD or significant infections. It is very difficult to give the drug.”
In the future, “if we truly want to optimize the benefit of using hypomethylating agents after transplantation, it’s going to be very important for us to understand how they work,” he said. “Understanding that would then help us to select which drug we should use, what the dosing and schedule might be, and also to select patients that might benefit from it. Unfortunately, right now, it’s pretty much of a black box. We don’t really understand the effects of hypomethylating agents in the posttransplant period.”
Still, he added, “without question, the results that we have seen with the use of hypomethylating agents after conventional chemotherapy – prolonging disease-free and, probably, overall survival – are going to provide a very, very strong stimulus to study hypomethylating agents after transplantation as well.”
Dr. Appelbaum reports no disclosures.
The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.
Hematopoietic stem cell transplantation (HCT) is one of the most important treatment options for acute leukemias. However, posttransplant cancer recurrence remains a continuing issue. And while there are reasons to think that hypomethylating agents (HMAS) could be helpful as maintenance tools to prevent cancer recurrence after HCT in leukemia, a hematologist/oncologist told colleagues that the treatment isn’t yet ready for prime time.
“I don’t think you can prefer hypomethylating agents over anything right now. Unfortunately, there’s no data that we can hang our hat on that says they are of benefit in the posttransplant setting,” said Frederick Appelbaum, MD, executive vice president and deputy director of the Fred Hutchinson Cancer Research Center, Seattle, in a presentation at the virtual Acute Leukemia Forum of Hemedicus.
However, there’s still plenty of room for improvement for patients following HCT, he said, pointing to the findings of a 2020 study. The report, which he cowrote, found that 200-day mortality after HCT fell by a third from 2003-2007 to 2013-20017, but also noted that “relapse of cancer remains the largest obstacle to better survival outcomes.”
Dr. Appelbaum described the findings this way: “Without a doubt, the major limitation to transplants for hematologic malignancies today is disease recurrence,” he said. “In fact, if you look at patients after day 100, over 60% of the reason for failure is tumor regrowth. Thus, people are very anxious to look at any method that we can to prevent posttransplant relapse, including the use of hypomethylating agents.”
In regard to strategy, “we don’t have to get rid of every last leukemic cell. Just delaying recurrence might be enough,” he said. “If you can keep the patient from relapsing for the first 3 months, and then take the brakes off the immune suppression and allow immunity to regrow, that may be enough to allow increased numbers of patients to be cured of their disease.”
A potential role
Why might HMAS be a possible option after transplant? They do appear to play a role after chemotherapy, he said, pointing to four 2019 studies: One that examined decitabine and three that examined azacytidine: Here, here, and here.
“These four studies provide convincing evidence that hypomethylating-agent therapy after conventional chemotherapy may either prevent or delay relapse when given as maintenance,” Dr. Appelbaum said.
If HMAS work after standard chemotherapy, why might they fail to work after transplantation? “For one, by the time the disease has been able to go through chemotherapy and transplant, you’re left with highly resistant cells,” he said. “Therefore, hypomethylating agents may not be enough to get rid of the disease. Secondly, any of you who have tried to give a maintenance therapy after transplantation know how difficult it can be with CMV [cytomegalovirus] reactivation, count suppression with ganciclovir, graft-versus-host disease [GVHD] causing nausea and vomiting, diarrhea and renal dysfunction caused by calcineurin inhibitors. These are daily events during the first 3 months after transplantation, making drug administration difficult.”
In addition, he said, “even if you can give the drug, the clinical and disease variability may make it very difficult to detect an effect.”
In another study, researchers “did make a valiant attempt to study azacitidine in the posttransplant setting by randomizing 181 patients to either azacitidine or observation,” Dr. Appelbaum said. “Unfortunately, as they reported in 2018, they could not detect a difference in either disease-free or overall survival.”
The researchers reported that nearly 75% of patients in the azacitidine arm failed to complete the planned 12 cycles of treatment, he said. “The reasons for stopping the drug were pretty profound. Half of the patients stopped because they relapsed. Others had stopped because of grades three or four toxicity, death, or severe GVHD or significant infections. It is very difficult to give the drug.”
In the future, “if we truly want to optimize the benefit of using hypomethylating agents after transplantation, it’s going to be very important for us to understand how they work,” he said. “Understanding that would then help us to select which drug we should use, what the dosing and schedule might be, and also to select patients that might benefit from it. Unfortunately, right now, it’s pretty much of a black box. We don’t really understand the effects of hypomethylating agents in the posttransplant period.”
Still, he added, “without question, the results that we have seen with the use of hypomethylating agents after conventional chemotherapy – prolonging disease-free and, probably, overall survival – are going to provide a very, very strong stimulus to study hypomethylating agents after transplantation as well.”
Dr. Appelbaum reports no disclosures.
The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.
Hematopoietic stem cell transplantation (HCT) is one of the most important treatment options for acute leukemias. However, posttransplant cancer recurrence remains a continuing issue. And while there are reasons to think that hypomethylating agents (HMAS) could be helpful as maintenance tools to prevent cancer recurrence after HCT in leukemia, a hematologist/oncologist told colleagues that the treatment isn’t yet ready for prime time.
“I don’t think you can prefer hypomethylating agents over anything right now. Unfortunately, there’s no data that we can hang our hat on that says they are of benefit in the posttransplant setting,” said Frederick Appelbaum, MD, executive vice president and deputy director of the Fred Hutchinson Cancer Research Center, Seattle, in a presentation at the virtual Acute Leukemia Forum of Hemedicus.
However, there’s still plenty of room for improvement for patients following HCT, he said, pointing to the findings of a 2020 study. The report, which he cowrote, found that 200-day mortality after HCT fell by a third from 2003-2007 to 2013-20017, but also noted that “relapse of cancer remains the largest obstacle to better survival outcomes.”
Dr. Appelbaum described the findings this way: “Without a doubt, the major limitation to transplants for hematologic malignancies today is disease recurrence,” he said. “In fact, if you look at patients after day 100, over 60% of the reason for failure is tumor regrowth. Thus, people are very anxious to look at any method that we can to prevent posttransplant relapse, including the use of hypomethylating agents.”
In regard to strategy, “we don’t have to get rid of every last leukemic cell. Just delaying recurrence might be enough,” he said. “If you can keep the patient from relapsing for the first 3 months, and then take the brakes off the immune suppression and allow immunity to regrow, that may be enough to allow increased numbers of patients to be cured of their disease.”
A potential role
Why might HMAS be a possible option after transplant? They do appear to play a role after chemotherapy, he said, pointing to four 2019 studies: One that examined decitabine and three that examined azacytidine: Here, here, and here.
“These four studies provide convincing evidence that hypomethylating-agent therapy after conventional chemotherapy may either prevent or delay relapse when given as maintenance,” Dr. Appelbaum said.
If HMAS work after standard chemotherapy, why might they fail to work after transplantation? “For one, by the time the disease has been able to go through chemotherapy and transplant, you’re left with highly resistant cells,” he said. “Therefore, hypomethylating agents may not be enough to get rid of the disease. Secondly, any of you who have tried to give a maintenance therapy after transplantation know how difficult it can be with CMV [cytomegalovirus] reactivation, count suppression with ganciclovir, graft-versus-host disease [GVHD] causing nausea and vomiting, diarrhea and renal dysfunction caused by calcineurin inhibitors. These are daily events during the first 3 months after transplantation, making drug administration difficult.”
In addition, he said, “even if you can give the drug, the clinical and disease variability may make it very difficult to detect an effect.”
In another study, researchers “did make a valiant attempt to study azacitidine in the posttransplant setting by randomizing 181 patients to either azacitidine or observation,” Dr. Appelbaum said. “Unfortunately, as they reported in 2018, they could not detect a difference in either disease-free or overall survival.”
The researchers reported that nearly 75% of patients in the azacitidine arm failed to complete the planned 12 cycles of treatment, he said. “The reasons for stopping the drug were pretty profound. Half of the patients stopped because they relapsed. Others had stopped because of grades three or four toxicity, death, or severe GVHD or significant infections. It is very difficult to give the drug.”
In the future, “if we truly want to optimize the benefit of using hypomethylating agents after transplantation, it’s going to be very important for us to understand how they work,” he said. “Understanding that would then help us to select which drug we should use, what the dosing and schedule might be, and also to select patients that might benefit from it. Unfortunately, right now, it’s pretty much of a black box. We don’t really understand the effects of hypomethylating agents in the posttransplant period.”
Still, he added, “without question, the results that we have seen with the use of hypomethylating agents after conventional chemotherapy – prolonging disease-free and, probably, overall survival – are going to provide a very, very strong stimulus to study hypomethylating agents after transplantation as well.”
Dr. Appelbaum reports no disclosures.
The Acute Leukemia Forum is held by Hemedicus, which is owned by the same company as this news organization.
FROM ALF 2020