User login
News and Views that Matter to Pediatricians
The leading independent newspaper covering news and commentary in pediatrics.
How to help families get through climate-related disasters
Wildfires burned millions of acres in California, Oregon, and Washington this year. Record numbers of tropical storms and hurricanes formed in the Atlantic. “Climate change is here. Disasters are here. They are going to be increasing, which is why we want to talk about this and talk about how pediatricians can help and respond to these events,” Scott Needle, MD, said at the annual meeting American Academy of Pediatrics, held virtually this year.
said Dr. Needle, chief medical officer of Elica Health Centers in Sacramento, California. “We can be a positive influence in terms of getting out proactive messaging and keeping people informed.”
The Federal Emergency Management Agency (FEMA) 2019 National Household Survey found that about half of households had an emergency plan. A theme across surveys is that, although households take some steps to get ready for disasters, the public generally “is not as prepared for these events as they really need to be,” Dr. Needle said.
The AAP, the Red Cross, and FEMA are among the organizations that offer planning guides, most of which emphasize three simple things: have a kit, have a plan, and be informed, he said.
To prepare for a disaster, parents might refill a child’s medications ahead of time if possible, Dr. Needle suggested. And during the COVID-19 pandemic, families should add masks, sanitizers, and wipes to their go-bags.
Physicians also can help families by asking how they are coping.
Wildfire smoke
“Smoke from wildfires can blanket large, large areas,” Mark Miller, MD, MPH, said during the presentation at the AAP meeting. “This year, we have seen wildfire smoke from the western states reach all the way to the East Coast. So this impacts your patients and your own families sometimes, regardless of wherever you live.”
Children may be more vulnerable to wildfire smoke because they often spend more time outdoors and tend to be more active. In addition, their ongoing development means exposure to air pollutants could have lifelong consequences, said Dr. Miller, who recently reviewed the effects of wildfire smoke on children.
“Children with asthma should have some information about wildfires built into their asthma management plan,” said Dr. Miller, who is affiliated with Western States Pediatric Environmental Health Specialty Unit (PEHSU) and University of California, San Francisco. Pollutants are associated with respiratory visits and admissions, asthma exacerbations, decreased lung function, and neurocognitive effects. They also may be carcinogenic.
A study in monkeys found that smoke exposure during California wildfires in 2008 was associated with immune dysregulation and compromised lung function in adolescence.
Another study of three cohorts of children in southern California found that air pollutant levels were associated with children’s lung function.
Organizations have provided resources on creating cleaner air spaces during wildfires, including guides to build DIY air filter fans. AirNow.gov provides air quality and fire maps that can inform decisions about school closures and outdoor activities. Communities should prioritize establishing schools as clean air shelters, Dr. Miller suggested.
Studies have found that respirators and medical masks may decrease children’s exposure to smoke. Children should not use face coverings, however, if they are younger than 2 years, if they are not able to remove the face covering on their own or tell an adult that they need help, or if they have difficulty breathing with a face covering. Younger children should be observed by an adult.
During the pandemic, families should be aware that some types of masks are sold only for health care use, many foreign respirators are counterfeit, and cloth masks used for COVID-19 are not suitable for reducing wildfire smoke exposure, Dr. Miller said.
Hazards may linger
Long-term mental health issues may be the disaster consequence that pediatricians encounter most often, Dr. Needle said.
Eighteen months after a major wildfire in Canada, more than one-third of middle and high school students in one community had probable posttraumatic stress disorder (that is, intrusive thoughts, avoidance, and increased arousal). In addition, 31% of students had probable depression. Rates were elevated relative to a control group of students in another community that was not affected by the fire.
Findings indicate that a patient’s degree of exposure to a disaster affects the likelihood of adverse outcomes. On the other hand, resiliency may help mitigate adverse effects. “The hope is that if we can find ways to encourage resiliency before or in the aftermath of an event, we may be able to, in a sense, reduce some of these mental health sequelae,” Dr. Needle said.
Posttraumatic reactions in kids are likely after a disaster. “They may not rise to the level of a diagnosable condition, but they are very common in kids,” he said. “It is important to at least be able to counsel parents to recognize some of the common reactions,” such as acting withdrawn or aggressive, somatic complaints, and having trouble sleeping.
The AAP has a policy statement that encourages talking to children about their concerns with honest and age-appropriate responses, he noted.
When returning to an area after a disaster, many hazards may remain, such as floodwaters, ash pits, mold, and carbon monoxide from generators. “Generally speaking, you don’t want to have kids return to these areas until it is safe,” Dr. Needle said.
Exacerbation of existing conditions – perhaps because of lost medications, smoke exposure, or stress – may be another common problem. Other problems after a disaster could include domestic violence (direct or witnessed) and substance abuse.
“We have a responsibility to take care of our own health as well,” Dr. Needle added. “You can’t take care of others if you’re not taking care of yourself. It’s not being selfish. As a matter of fact, it’s being prudent. It’s survival.”
Dr. Needle and Dr. Miller had no relevant financial disclosures. Dr. Miller’s presentation was supported by the AAP and funded in part by the Agency for Toxic Substances and Disease Registry. The U.S. Environmental Protection Agency (EPA) provides funding support for the Pediatric Environmental Health Specialty Unit.
Wildfires burned millions of acres in California, Oregon, and Washington this year. Record numbers of tropical storms and hurricanes formed in the Atlantic. “Climate change is here. Disasters are here. They are going to be increasing, which is why we want to talk about this and talk about how pediatricians can help and respond to these events,” Scott Needle, MD, said at the annual meeting American Academy of Pediatrics, held virtually this year.
said Dr. Needle, chief medical officer of Elica Health Centers in Sacramento, California. “We can be a positive influence in terms of getting out proactive messaging and keeping people informed.”
The Federal Emergency Management Agency (FEMA) 2019 National Household Survey found that about half of households had an emergency plan. A theme across surveys is that, although households take some steps to get ready for disasters, the public generally “is not as prepared for these events as they really need to be,” Dr. Needle said.
The AAP, the Red Cross, and FEMA are among the organizations that offer planning guides, most of which emphasize three simple things: have a kit, have a plan, and be informed, he said.
To prepare for a disaster, parents might refill a child’s medications ahead of time if possible, Dr. Needle suggested. And during the COVID-19 pandemic, families should add masks, sanitizers, and wipes to their go-bags.
Physicians also can help families by asking how they are coping.
Wildfire smoke
“Smoke from wildfires can blanket large, large areas,” Mark Miller, MD, MPH, said during the presentation at the AAP meeting. “This year, we have seen wildfire smoke from the western states reach all the way to the East Coast. So this impacts your patients and your own families sometimes, regardless of wherever you live.”
Children may be more vulnerable to wildfire smoke because they often spend more time outdoors and tend to be more active. In addition, their ongoing development means exposure to air pollutants could have lifelong consequences, said Dr. Miller, who recently reviewed the effects of wildfire smoke on children.
“Children with asthma should have some information about wildfires built into their asthma management plan,” said Dr. Miller, who is affiliated with Western States Pediatric Environmental Health Specialty Unit (PEHSU) and University of California, San Francisco. Pollutants are associated with respiratory visits and admissions, asthma exacerbations, decreased lung function, and neurocognitive effects. They also may be carcinogenic.
A study in monkeys found that smoke exposure during California wildfires in 2008 was associated with immune dysregulation and compromised lung function in adolescence.
Another study of three cohorts of children in southern California found that air pollutant levels were associated with children’s lung function.
Organizations have provided resources on creating cleaner air spaces during wildfires, including guides to build DIY air filter fans. AirNow.gov provides air quality and fire maps that can inform decisions about school closures and outdoor activities. Communities should prioritize establishing schools as clean air shelters, Dr. Miller suggested.
Studies have found that respirators and medical masks may decrease children’s exposure to smoke. Children should not use face coverings, however, if they are younger than 2 years, if they are not able to remove the face covering on their own or tell an adult that they need help, or if they have difficulty breathing with a face covering. Younger children should be observed by an adult.
During the pandemic, families should be aware that some types of masks are sold only for health care use, many foreign respirators are counterfeit, and cloth masks used for COVID-19 are not suitable for reducing wildfire smoke exposure, Dr. Miller said.
Hazards may linger
Long-term mental health issues may be the disaster consequence that pediatricians encounter most often, Dr. Needle said.
Eighteen months after a major wildfire in Canada, more than one-third of middle and high school students in one community had probable posttraumatic stress disorder (that is, intrusive thoughts, avoidance, and increased arousal). In addition, 31% of students had probable depression. Rates were elevated relative to a control group of students in another community that was not affected by the fire.
Findings indicate that a patient’s degree of exposure to a disaster affects the likelihood of adverse outcomes. On the other hand, resiliency may help mitigate adverse effects. “The hope is that if we can find ways to encourage resiliency before or in the aftermath of an event, we may be able to, in a sense, reduce some of these mental health sequelae,” Dr. Needle said.
Posttraumatic reactions in kids are likely after a disaster. “They may not rise to the level of a diagnosable condition, but they are very common in kids,” he said. “It is important to at least be able to counsel parents to recognize some of the common reactions,” such as acting withdrawn or aggressive, somatic complaints, and having trouble sleeping.
The AAP has a policy statement that encourages talking to children about their concerns with honest and age-appropriate responses, he noted.
When returning to an area after a disaster, many hazards may remain, such as floodwaters, ash pits, mold, and carbon monoxide from generators. “Generally speaking, you don’t want to have kids return to these areas until it is safe,” Dr. Needle said.
Exacerbation of existing conditions – perhaps because of lost medications, smoke exposure, or stress – may be another common problem. Other problems after a disaster could include domestic violence (direct or witnessed) and substance abuse.
“We have a responsibility to take care of our own health as well,” Dr. Needle added. “You can’t take care of others if you’re not taking care of yourself. It’s not being selfish. As a matter of fact, it’s being prudent. It’s survival.”
Dr. Needle and Dr. Miller had no relevant financial disclosures. Dr. Miller’s presentation was supported by the AAP and funded in part by the Agency for Toxic Substances and Disease Registry. The U.S. Environmental Protection Agency (EPA) provides funding support for the Pediatric Environmental Health Specialty Unit.
Wildfires burned millions of acres in California, Oregon, and Washington this year. Record numbers of tropical storms and hurricanes formed in the Atlantic. “Climate change is here. Disasters are here. They are going to be increasing, which is why we want to talk about this and talk about how pediatricians can help and respond to these events,” Scott Needle, MD, said at the annual meeting American Academy of Pediatrics, held virtually this year.
said Dr. Needle, chief medical officer of Elica Health Centers in Sacramento, California. “We can be a positive influence in terms of getting out proactive messaging and keeping people informed.”
The Federal Emergency Management Agency (FEMA) 2019 National Household Survey found that about half of households had an emergency plan. A theme across surveys is that, although households take some steps to get ready for disasters, the public generally “is not as prepared for these events as they really need to be,” Dr. Needle said.
The AAP, the Red Cross, and FEMA are among the organizations that offer planning guides, most of which emphasize three simple things: have a kit, have a plan, and be informed, he said.
To prepare for a disaster, parents might refill a child’s medications ahead of time if possible, Dr. Needle suggested. And during the COVID-19 pandemic, families should add masks, sanitizers, and wipes to their go-bags.
Physicians also can help families by asking how they are coping.
Wildfire smoke
“Smoke from wildfires can blanket large, large areas,” Mark Miller, MD, MPH, said during the presentation at the AAP meeting. “This year, we have seen wildfire smoke from the western states reach all the way to the East Coast. So this impacts your patients and your own families sometimes, regardless of wherever you live.”
Children may be more vulnerable to wildfire smoke because they often spend more time outdoors and tend to be more active. In addition, their ongoing development means exposure to air pollutants could have lifelong consequences, said Dr. Miller, who recently reviewed the effects of wildfire smoke on children.
“Children with asthma should have some information about wildfires built into their asthma management plan,” said Dr. Miller, who is affiliated with Western States Pediatric Environmental Health Specialty Unit (PEHSU) and University of California, San Francisco. Pollutants are associated with respiratory visits and admissions, asthma exacerbations, decreased lung function, and neurocognitive effects. They also may be carcinogenic.
A study in monkeys found that smoke exposure during California wildfires in 2008 was associated with immune dysregulation and compromised lung function in adolescence.
Another study of three cohorts of children in southern California found that air pollutant levels were associated with children’s lung function.
Organizations have provided resources on creating cleaner air spaces during wildfires, including guides to build DIY air filter fans. AirNow.gov provides air quality and fire maps that can inform decisions about school closures and outdoor activities. Communities should prioritize establishing schools as clean air shelters, Dr. Miller suggested.
Studies have found that respirators and medical masks may decrease children’s exposure to smoke. Children should not use face coverings, however, if they are younger than 2 years, if they are not able to remove the face covering on their own or tell an adult that they need help, or if they have difficulty breathing with a face covering. Younger children should be observed by an adult.
During the pandemic, families should be aware that some types of masks are sold only for health care use, many foreign respirators are counterfeit, and cloth masks used for COVID-19 are not suitable for reducing wildfire smoke exposure, Dr. Miller said.
Hazards may linger
Long-term mental health issues may be the disaster consequence that pediatricians encounter most often, Dr. Needle said.
Eighteen months after a major wildfire in Canada, more than one-third of middle and high school students in one community had probable posttraumatic stress disorder (that is, intrusive thoughts, avoidance, and increased arousal). In addition, 31% of students had probable depression. Rates were elevated relative to a control group of students in another community that was not affected by the fire.
Findings indicate that a patient’s degree of exposure to a disaster affects the likelihood of adverse outcomes. On the other hand, resiliency may help mitigate adverse effects. “The hope is that if we can find ways to encourage resiliency before or in the aftermath of an event, we may be able to, in a sense, reduce some of these mental health sequelae,” Dr. Needle said.
Posttraumatic reactions in kids are likely after a disaster. “They may not rise to the level of a diagnosable condition, but they are very common in kids,” he said. “It is important to at least be able to counsel parents to recognize some of the common reactions,” such as acting withdrawn or aggressive, somatic complaints, and having trouble sleeping.
The AAP has a policy statement that encourages talking to children about their concerns with honest and age-appropriate responses, he noted.
When returning to an area after a disaster, many hazards may remain, such as floodwaters, ash pits, mold, and carbon monoxide from generators. “Generally speaking, you don’t want to have kids return to these areas until it is safe,” Dr. Needle said.
Exacerbation of existing conditions – perhaps because of lost medications, smoke exposure, or stress – may be another common problem. Other problems after a disaster could include domestic violence (direct or witnessed) and substance abuse.
“We have a responsibility to take care of our own health as well,” Dr. Needle added. “You can’t take care of others if you’re not taking care of yourself. It’s not being selfish. As a matter of fact, it’s being prudent. It’s survival.”
Dr. Needle and Dr. Miller had no relevant financial disclosures. Dr. Miller’s presentation was supported by the AAP and funded in part by the Agency for Toxic Substances and Disease Registry. The U.S. Environmental Protection Agency (EPA) provides funding support for the Pediatric Environmental Health Specialty Unit.
FROM AAP 2020
New return-to-play recommendations for athletes with COVID-19
The latest recommendations from sports cardiologists on getting athletes with COVID-19 back on the playing field safely emphasize a more judicious approach to screening for cardiac injury.
The new recommendations, made by the American College of Cardiology’s Sports and Exercise Cardiology Section, are for adult athletes in competitive sports and also for two important groups: younger athletes taking part in competitive high school sports and older athletes aged 35 and older, the Masters athletes, who continue to be active throughout their lives. The document was published online in JAMA Cardiology.
Because of the evolving nature of knowledge about COVID-19, updates on recommendations for safe return to play for athletes of all ages will continue to be made, senior author Aaron L. Baggish, MD, director of the cardiovascular performance program at Massachusetts General Hospital, Boston, said.
“The recommendations we released in May were entirely based on our experience taking care of hospitalized patients with COVID-19; we had no athletes in this population. We used a lot of conservative guesswork around how this would apply to otherwise healthy athletes,” Dr. Baggish said in an interview.
“But as sports started to open up, and we started to see large numbers of first professional and then college athletes come back into training, we realized that we needed to stop and ask whether the recommendations we put forward back in May were still appropriate,” Dr. Baggish said.
“Once we started to actually get into the trenches with these athletes, literally hundreds of them, and applying the testing strategies that we had initially recommended in everybody, we realized that we probably had some room for improvement, and that’s why we reconvened, to make these revisions,” he said.
Essentially, the recommendations now urge less cardiac testing. “Cardiac injury is not as common as we may have originally thought,” said Dr. Baggish.
“In the early days of COVID, people who were hospitalized had evidence of heart injury, and so we wondered if that prevalence would also be applicable to otherwise young, healthy people who got COVID. If that had been the case, we would have been in big trouble with respect to getting people back into sports. So this is why we started with a conservative screening approach and a lot of testing in order to not miss a huge burden of disease,” he said.
“But what we’ve learned over the past few months is that young people who get either asymptomatic or mild infection appear to have very, very low risk of having associated heart injury, so the need for testing in that population, when people who have infections recover fully, is almost certainly not going to be high yield,” Dr. Baggish said.
First iteration of the recommendations
Published in May in the early weeks of the pandemic, the first recommendations for safe return to play said that all athletes should stop training for at least 2 weeks after their symptoms resolve, then undergo “careful, clinical cardiovascular evaluation in combination with cardiac biomarkers and imaging.”
Additional testing with cardiac MRI, exercise testing, or ambulatory rhythm monitoring was to be done “based on the clinical course and initial testing.”
But experts caution that monitoring on such a scale in everyone is unnecessary and could even be counterproductive.
“Sending young athletes for extensive testing is not warranted and could send them to unnecessary testing, cardiac imaging, and so on,” Dr. Baggish said.
Only those athletes who continue to have symptoms or whose symptoms return when they get back to their athletic activities should go on for more screening.
“There, in essence, is the single main change from May, and that is a move away from screening with testing everyone, [and instead] confining that to the people who had moderate or greater severity disease,” he said.
Both iterations of the recommendations end with the same message.
“We are at the beginning of our knowledge about the cardiotoxic effects of COVID-19 but we are gathering evidence every day,” said Dr. Baggish. “Just as they did earlier, we acknowledge that our approaches are subject to change when we learn more about how COVID affects the heart, and specifically the hearts of athletes. This will be an ongoing process.”
Something to lean on
The recommendations are welcome, said James E. Udelson, MD, chief of the division of cardiology at Tufts Medical Center, Boston, coauthor of an accompanying editorial.
“It was a bit of the wild west out there, because each university, each college, all with good intentions, had been all struggling to figure out what to do, and how much to do. Probably the most important message from this new paper is the fact that now there is something out there that all coaches, athletes, families, schools, trainers can get some guidance from,” Dr. Udelson said in an interview.
Refining the cardiac screening criteria was a necessary step, Dr. Udelson said.
“How much cardiac imaging do you do? That is a matter of controversy,” said Dr. Udelson, who coauthored the commentary with Tufts cardiologist Ethan Rowin, MD, and Michael A. Curtis, MEd, a certified strength and conditioning specialist at the University of Virginia, Charlottesville. “The problem is that if you use a very sensitive imaging test on a lot of people, sometimes you find things that you really didn’t need to know about. They’re really not important. And now, the athlete is told he or she cannot play for 3 months because they might have myocarditis.
“Should we be too sensitive, meaning do we want to pick up anything no matter whether it’s important or not?” he added. “There will be a lot of false positives, and we are going to disqualify a lot of people. Or do you tune it a different way?”
Dr. Udelson said he would like to see commercial sports donate money to support research into the potential cardiotoxicity of COVID-19.
“If the organizations that benefit from these athletes, like the National Collegiate Athletic Association and professional sports leagues, can fund some of this research, that would be a huge help,” Dr. Udelson said.
“These are the top sports cardiologists in the country, and they have to start somewhere, and these are all based on what we know right now, as well as their own extensive experience. We all know that we are just at the beginning of our knowledge of this. But we have to have something to guide this huge community out there that is really thirsty for help.”
Dr. Baggish reports receiving research funding for the study of athletes in competitive sports from the National Heart, Lung, and Blood Institute; the National Football League Players Association; and the American Heart Association and receiving compensation for his role as team cardiologist from the US Olympic Committee/US Olympic Training Centers, US Soccer, US Rowing, the New England Patriots, the Boston Bruins, the New England Revolution, and Harvard University. Dr. Udelson has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The latest recommendations from sports cardiologists on getting athletes with COVID-19 back on the playing field safely emphasize a more judicious approach to screening for cardiac injury.
The new recommendations, made by the American College of Cardiology’s Sports and Exercise Cardiology Section, are for adult athletes in competitive sports and also for two important groups: younger athletes taking part in competitive high school sports and older athletes aged 35 and older, the Masters athletes, who continue to be active throughout their lives. The document was published online in JAMA Cardiology.
Because of the evolving nature of knowledge about COVID-19, updates on recommendations for safe return to play for athletes of all ages will continue to be made, senior author Aaron L. Baggish, MD, director of the cardiovascular performance program at Massachusetts General Hospital, Boston, said.
“The recommendations we released in May were entirely based on our experience taking care of hospitalized patients with COVID-19; we had no athletes in this population. We used a lot of conservative guesswork around how this would apply to otherwise healthy athletes,” Dr. Baggish said in an interview.
“But as sports started to open up, and we started to see large numbers of first professional and then college athletes come back into training, we realized that we needed to stop and ask whether the recommendations we put forward back in May were still appropriate,” Dr. Baggish said.
“Once we started to actually get into the trenches with these athletes, literally hundreds of them, and applying the testing strategies that we had initially recommended in everybody, we realized that we probably had some room for improvement, and that’s why we reconvened, to make these revisions,” he said.
Essentially, the recommendations now urge less cardiac testing. “Cardiac injury is not as common as we may have originally thought,” said Dr. Baggish.
“In the early days of COVID, people who were hospitalized had evidence of heart injury, and so we wondered if that prevalence would also be applicable to otherwise young, healthy people who got COVID. If that had been the case, we would have been in big trouble with respect to getting people back into sports. So this is why we started with a conservative screening approach and a lot of testing in order to not miss a huge burden of disease,” he said.
“But what we’ve learned over the past few months is that young people who get either asymptomatic or mild infection appear to have very, very low risk of having associated heart injury, so the need for testing in that population, when people who have infections recover fully, is almost certainly not going to be high yield,” Dr. Baggish said.
First iteration of the recommendations
Published in May in the early weeks of the pandemic, the first recommendations for safe return to play said that all athletes should stop training for at least 2 weeks after their symptoms resolve, then undergo “careful, clinical cardiovascular evaluation in combination with cardiac biomarkers and imaging.”
Additional testing with cardiac MRI, exercise testing, or ambulatory rhythm monitoring was to be done “based on the clinical course and initial testing.”
But experts caution that monitoring on such a scale in everyone is unnecessary and could even be counterproductive.
“Sending young athletes for extensive testing is not warranted and could send them to unnecessary testing, cardiac imaging, and so on,” Dr. Baggish said.
Only those athletes who continue to have symptoms or whose symptoms return when they get back to their athletic activities should go on for more screening.
“There, in essence, is the single main change from May, and that is a move away from screening with testing everyone, [and instead] confining that to the people who had moderate or greater severity disease,” he said.
Both iterations of the recommendations end with the same message.
“We are at the beginning of our knowledge about the cardiotoxic effects of COVID-19 but we are gathering evidence every day,” said Dr. Baggish. “Just as they did earlier, we acknowledge that our approaches are subject to change when we learn more about how COVID affects the heart, and specifically the hearts of athletes. This will be an ongoing process.”
Something to lean on
The recommendations are welcome, said James E. Udelson, MD, chief of the division of cardiology at Tufts Medical Center, Boston, coauthor of an accompanying editorial.
“It was a bit of the wild west out there, because each university, each college, all with good intentions, had been all struggling to figure out what to do, and how much to do. Probably the most important message from this new paper is the fact that now there is something out there that all coaches, athletes, families, schools, trainers can get some guidance from,” Dr. Udelson said in an interview.
Refining the cardiac screening criteria was a necessary step, Dr. Udelson said.
“How much cardiac imaging do you do? That is a matter of controversy,” said Dr. Udelson, who coauthored the commentary with Tufts cardiologist Ethan Rowin, MD, and Michael A. Curtis, MEd, a certified strength and conditioning specialist at the University of Virginia, Charlottesville. “The problem is that if you use a very sensitive imaging test on a lot of people, sometimes you find things that you really didn’t need to know about. They’re really not important. And now, the athlete is told he or she cannot play for 3 months because they might have myocarditis.
“Should we be too sensitive, meaning do we want to pick up anything no matter whether it’s important or not?” he added. “There will be a lot of false positives, and we are going to disqualify a lot of people. Or do you tune it a different way?”
Dr. Udelson said he would like to see commercial sports donate money to support research into the potential cardiotoxicity of COVID-19.
“If the organizations that benefit from these athletes, like the National Collegiate Athletic Association and professional sports leagues, can fund some of this research, that would be a huge help,” Dr. Udelson said.
“These are the top sports cardiologists in the country, and they have to start somewhere, and these are all based on what we know right now, as well as their own extensive experience. We all know that we are just at the beginning of our knowledge of this. But we have to have something to guide this huge community out there that is really thirsty for help.”
Dr. Baggish reports receiving research funding for the study of athletes in competitive sports from the National Heart, Lung, and Blood Institute; the National Football League Players Association; and the American Heart Association and receiving compensation for his role as team cardiologist from the US Olympic Committee/US Olympic Training Centers, US Soccer, US Rowing, the New England Patriots, the Boston Bruins, the New England Revolution, and Harvard University. Dr. Udelson has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
The latest recommendations from sports cardiologists on getting athletes with COVID-19 back on the playing field safely emphasize a more judicious approach to screening for cardiac injury.
The new recommendations, made by the American College of Cardiology’s Sports and Exercise Cardiology Section, are for adult athletes in competitive sports and also for two important groups: younger athletes taking part in competitive high school sports and older athletes aged 35 and older, the Masters athletes, who continue to be active throughout their lives. The document was published online in JAMA Cardiology.
Because of the evolving nature of knowledge about COVID-19, updates on recommendations for safe return to play for athletes of all ages will continue to be made, senior author Aaron L. Baggish, MD, director of the cardiovascular performance program at Massachusetts General Hospital, Boston, said.
“The recommendations we released in May were entirely based on our experience taking care of hospitalized patients with COVID-19; we had no athletes in this population. We used a lot of conservative guesswork around how this would apply to otherwise healthy athletes,” Dr. Baggish said in an interview.
“But as sports started to open up, and we started to see large numbers of first professional and then college athletes come back into training, we realized that we needed to stop and ask whether the recommendations we put forward back in May were still appropriate,” Dr. Baggish said.
“Once we started to actually get into the trenches with these athletes, literally hundreds of them, and applying the testing strategies that we had initially recommended in everybody, we realized that we probably had some room for improvement, and that’s why we reconvened, to make these revisions,” he said.
Essentially, the recommendations now urge less cardiac testing. “Cardiac injury is not as common as we may have originally thought,” said Dr. Baggish.
“In the early days of COVID, people who were hospitalized had evidence of heart injury, and so we wondered if that prevalence would also be applicable to otherwise young, healthy people who got COVID. If that had been the case, we would have been in big trouble with respect to getting people back into sports. So this is why we started with a conservative screening approach and a lot of testing in order to not miss a huge burden of disease,” he said.
“But what we’ve learned over the past few months is that young people who get either asymptomatic or mild infection appear to have very, very low risk of having associated heart injury, so the need for testing in that population, when people who have infections recover fully, is almost certainly not going to be high yield,” Dr. Baggish said.
First iteration of the recommendations
Published in May in the early weeks of the pandemic, the first recommendations for safe return to play said that all athletes should stop training for at least 2 weeks after their symptoms resolve, then undergo “careful, clinical cardiovascular evaluation in combination with cardiac biomarkers and imaging.”
Additional testing with cardiac MRI, exercise testing, or ambulatory rhythm monitoring was to be done “based on the clinical course and initial testing.”
But experts caution that monitoring on such a scale in everyone is unnecessary and could even be counterproductive.
“Sending young athletes for extensive testing is not warranted and could send them to unnecessary testing, cardiac imaging, and so on,” Dr. Baggish said.
Only those athletes who continue to have symptoms or whose symptoms return when they get back to their athletic activities should go on for more screening.
“There, in essence, is the single main change from May, and that is a move away from screening with testing everyone, [and instead] confining that to the people who had moderate or greater severity disease,” he said.
Both iterations of the recommendations end with the same message.
“We are at the beginning of our knowledge about the cardiotoxic effects of COVID-19 but we are gathering evidence every day,” said Dr. Baggish. “Just as they did earlier, we acknowledge that our approaches are subject to change when we learn more about how COVID affects the heart, and specifically the hearts of athletes. This will be an ongoing process.”
Something to lean on
The recommendations are welcome, said James E. Udelson, MD, chief of the division of cardiology at Tufts Medical Center, Boston, coauthor of an accompanying editorial.
“It was a bit of the wild west out there, because each university, each college, all with good intentions, had been all struggling to figure out what to do, and how much to do. Probably the most important message from this new paper is the fact that now there is something out there that all coaches, athletes, families, schools, trainers can get some guidance from,” Dr. Udelson said in an interview.
Refining the cardiac screening criteria was a necessary step, Dr. Udelson said.
“How much cardiac imaging do you do? That is a matter of controversy,” said Dr. Udelson, who coauthored the commentary with Tufts cardiologist Ethan Rowin, MD, and Michael A. Curtis, MEd, a certified strength and conditioning specialist at the University of Virginia, Charlottesville. “The problem is that if you use a very sensitive imaging test on a lot of people, sometimes you find things that you really didn’t need to know about. They’re really not important. And now, the athlete is told he or she cannot play for 3 months because they might have myocarditis.
“Should we be too sensitive, meaning do we want to pick up anything no matter whether it’s important or not?” he added. “There will be a lot of false positives, and we are going to disqualify a lot of people. Or do you tune it a different way?”
Dr. Udelson said he would like to see commercial sports donate money to support research into the potential cardiotoxicity of COVID-19.
“If the organizations that benefit from these athletes, like the National Collegiate Athletic Association and professional sports leagues, can fund some of this research, that would be a huge help,” Dr. Udelson said.
“These are the top sports cardiologists in the country, and they have to start somewhere, and these are all based on what we know right now, as well as their own extensive experience. We all know that we are just at the beginning of our knowledge of this. But we have to have something to guide this huge community out there that is really thirsty for help.”
Dr. Baggish reports receiving research funding for the study of athletes in competitive sports from the National Heart, Lung, and Blood Institute; the National Football League Players Association; and the American Heart Association and receiving compensation for his role as team cardiologist from the US Olympic Committee/US Olympic Training Centers, US Soccer, US Rowing, the New England Patriots, the Boston Bruins, the New England Revolution, and Harvard University. Dr. Udelson has disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Burnout risk may be exacerbated by COVID crisis
New kinds of job stress multiply in unusual times
Clarissa Barnes, MD, a hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and until recently medical director of Avera’s LIGHT Program, a wellness-oriented service for doctors, nurse practitioners, and physician assistants, watched the COVID-19 crisis unfold up close in her community and her hospital. Sioux Falls traced its surge of COVID patients to an outbreak at a local meatpacking plant.
“In the beginning, we didn’t know much about the virus and its communicability, although we have since gotten a better handle on that,” she said. “We had questions: Should we give patients more fluids – or less? Steroids or not? In my experience as a hospitalist I never had patients die every day on my shift, but that was happening with COVID.” The crisis imposed serious stresses on frontline providers, and hospitalists were concerned about personal safety and exposure risk – not just for themselves but for their families.
“The first time I worked on the COVID unit, I moved into the guest room in our home, apart from my husband and our young children,” Dr. Barnes said. “Ultimately I caught the virus, although I have since recovered.” Her experience has highlighted how existing issues of job stress and burnout in hospital medicine have been exacerbated by COVID-19. Even physicians who consider themselves healthy may have little emotional reserve to draw upon in a crisis of this magnitude.
“We are social distancing at work, wearing masks, not eating together with our colleagues – with less camaraderie and social support than we used to have,” she said. “I feel exhausted and there’s no question that my colleagues and I have sacrificed a lot to deal with the pandemic.” Add to that the second front of the COVID-19 crisis, Dr. Barnes said, which is “fighting the medical information wars, trying to correct misinformation put out there by people. Physicians who have been on the front lines of the pandemic know how demoralizing it can be to have people negate your first-hand experience.”
The situation has gotten better in Sioux Falls, Dr. Barnes said, although cases have started rising in the state again. The stress, while not gone, is reduced. For some doctors, “COVID reminded us of why we do what we do. Some of the usual bureaucratic requirements were set aside and we could focus on what our patients needed and how to take care of them.”
Taking job stress seriously
Tiffani Panek, MA, SFHM, CLHM, administrator of the division of hospital medicine at Johns Hopkins Bayview Medical Center in Baltimore, said job stress is a major issue for hospitalist groups.
“We take it seriously here, and use a survey tool to measure morale in our group annually,” she said. “So far, knock on wood, Baltimore has not been one of the big hot spots, but we’ve definitely had waves of COVID patients.”
The Bayview hospitalist group has a diversified set of leaders, including a wellness director. “They’re always checking up on our people, keeping an eye on those who are most vulnerable. One of the stressors we hadn’t thought about before was for our people who live alone. With the isolation and lockdown, they haven’t been able to socialize, so we’ve made direct outreach, asking people how they were doing,” Ms. Panek said. “People know we’ve got their back – professionally and personally. They know, if there’s something we can do to help, we will do it.”
Bayview Medical Center has COVID-specific units and non-COVID units, and has tried to rotate hospitalist assignments because more than a couple days in a row spent wearing full personal protective equipment (PPE) is exhausting, Ms. Panek said. The group also allocated a respite room just outside the biocontainment unit, with a computer and opportunities for providers to just sit and take a breather – with appropriate social distancing. “It’s not fancy, but you just have to wear a mask, not full PPE.”
The Hopkins hospitalist group’s wellness director, Catherine Washburn, MD, also a working hospitalist, said providers are exhausted, and trying to transition to the new normal is a moving target.
“It’s hard for anyone to say what our lives will look like in 6 months,” she said. “People in our group have lost family members to COVID, or postponed major life events, like weddings. We acknowledge losses together as a group, and celebrate things worth celebrating, like babies or birthdays.”
Greatest COVID caseload
Joshua Case, MD, hospitalist medical director for 16 acute care hospitals of Northwell Health serving metropolitan New York City and Long Island, said his group’s hospitalists and other staff worked incredibly hard during the surge of COVID-19 patients in New York. “Northwell likely cared for more COVID patients than any other health care system in the U.S., if not the world.
“It’s vastly different now. We went from a peak of thousands of cases per day down to about 70-90 new cases a day across our system. We’re lucky our system recognized that COVID could be an issue early on, with all of the multifaceted stressors on patient care,” Dr. Case said. “We’ve done whatever we could to give people time off, especially as the census started to come down. We freed up as many supportive mental health services as we could, working with the health system’s employee assistance program.”
Northwell gave out numbers for the psychiatry department, with clinicians available 24/7 for a confidential call, along with outside volunteers and a network of trauma psychologists. “Our system also provided emergency child care for staff, including hospitalists, wherever we could, drawing upon community resources,” Dr. Case added.
“We recognize that we’re all in the same foxhole. That’s been a helpful attitude – recognizing that it’s okay to be upset in a crisis and to have trouble dealing with what’s going on,” he said. “We need to acknowledge that some of us are suffering and try to encourage people to face it head on. For a lot of physicians, especially those who were redeployed here from other departments, it was important just to have us ask if they were doing okay.”
Brian Schroeder, MHA, FACHE, FHM, assistant vice president for hospital and emergency medicine for Atrium Health, based in Charlotte, N.C., said one of the biggest sources of stress on his staff has been the constant pace of change – whether local hospital protocols, state policies, or guidelines from the Centers for Disease Control and Prevention. “The updating is difficult to keep up with. A lot of our physicians get worried and anxious that they’re not following the latest guidelines or correctly doing what they should be doing to care for COVID patients. One thing we’ve done to alleviate some of that fear and anxiety is through weekly huddles with our hospital teams, focusing on changes relevant to their work. We also have weekly ‘all-hands’ meetings for our 250 providers across 13 acute and four postacute facilities.”
Before COVID, it was difficult to get everyone together as one big group from hospitals up to 5 hours apart, but with the Microsoft Teams platform, they can all meet together.
“At the height of the pandemic, we’d convene weekly and share national statistics, organizational statistics, testing updates, changes to protocols,” Mr. Schroeder said. As the pace of change has slowed, these meetings were cut back to monthly. “Our physicians feel we are passing on information as soon as we get it. They know we’ll always tell them what we know.”
Sarah Richards, MD, assistant professor of internal medicine at the University of Nebraska, Omaha, who heads the Society of Hospital Medicine’s Well-Being Task Force, formed to address staff stress in the COVID environment, said there are things that health care systems can do to help mitigate job stress and burnout. But broader issues may need to be addressed at a national level. “SHM is trying to understand work-related stress – and to identify resources that could support doctors, so they can spend more of their time doing what they enjoy most, which is taking care of patients,” she said.
“We also recognize that people have had very different experiences, depending on geography, and at the individual level stressors are experienced very differently,” Dr. Richard noted. “One of the most common stressors we’ve heard from doctors is the challenge of caring for patients who are lonely and isolated in their hospital rooms, suffering and dying in new ways. In low-incidence areas, doctors are expressing guilt because they aren’t under as much stress as their colleagues. In high-incidence areas, doctors are already experiencing posttraumatic stress disorder.”
SHM’s Well-Being Task Force is working on a tool to help normalize these stressors and encourage open conversations about mental health issues. A guide called “HM COVID Check-in Guide for Self & Peers” is designed to help hospitalists break the culture of silence around well-being and burnout during COVID-19 and how people are handling and processing the pandemic experience. It is expected to be completed later this year, Dr. Richards said. Other SHM projects and resources for staff support are also in the works.
The impact on women doctors
In a recent Journal of Hospital Medicine article entitled “Collateral Damage: How COVID-19 is Adversely Impacting Women Physicians,” hospitalist Yemisi Jones, MD, medical director of continuing medical education at Cincinnati Children’s Hospital Medical Center, and colleagues argue that preexisting gender inequities in compensation, academic rank and leadership positions for physicians have made the COVID-19 crisis even more burdensome on female hospitalists.1
“Increased childcare and schooling obligations, coupled with disproportionate household responsibilities and an inability to work from home, will likely result in female hospitalists struggling to meet family needs while pandemic-related work responsibilities are ramping up,” they write. COVID may intensify workplace inequalities, with a lack of recognition of the undue strain that group policies place on women.
“Often women suffer in silence,” said coauthor Jennifer O’Toole, MD, MEd, director of education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center and program director of the internal medicine–pediatrics residency. “We are not always the best self-advocates, although many of us are working on that.”
When women in hospital medicine take leadership roles, these often tend to involve mutual support activities, taking care of colleagues, and promoting collaborative work environments, Dr. Jones added. The stereotypical example is the committee that organizes celebrations when group members get married or have babies.
These activities can take a lot of time, she said. “We need to pay attention to that kind of role in our groups, because it’s important to the cohesiveness of the group. But it often goes unrecognized and doesn’t translate into the currency of promotion and leadership in medicine. When women go for promotions in the future, how will what happened during the COVID crisis impact their opportunities?”
What is the answer to overcoming these systemic inequities? Start with making sure women are part of the leadership team, with responsibilities for group policies, schedules, and other important decisions. “Look at your group’s leadership – particularly the higher positions. If it’s not diverse, ask why. ‘What is it about the structure of our group?’ Make a more concerted effort in your recruitment and retention,” Dr. Jones said.
The JHM article also recommends closely monitoring the direct and indirect effects of COVID-19 on female hospitalists, inquiring specifically about the needs of women in the organization, and ensuring that diversity, inclusion, and equity efforts are not suspended during the pandemic. Gender-based disparities in pay also need a closer look, and not just one time but reviewed periodically and adjusted accordingly.
Mentoring for early career women is important, but more so is sponsorship – someone in a high-level leadership role in the group sponsoring women who are rising up the career ladder, Dr. O’Toole said. “Professional women tend to be overmentored and undersponsored.”
What are the answers?
Ultimately, listening is key to try to help people get through the pandemic, Dr. Washburn said. “People become burned out when they feel leadership doesn’t understand their needs or doesn’t hear their concerns. Our group leaders all do clinical work, so they are seen as one of us. They try very hard; they have listening ears. But listening is just the first step. Next step is to work creatively to get the identified needs met.”
A few years ago, Johns Hopkins developed training in enhanced communication in health care for all hospital providers, including nurses and doctors, encouraging them to get trained in how to actively listen and address their patients’ emotional and social experiences as well as disease, Dr. Washburn explained. Learning how to listen better to patients can enhance skills at listening to colleagues, and vice versa. “We recognize the importance of better communication – for reducing sentinel events in the hospital and also for preventing staff burnout.”
Dr. Barnes also does physician coaching, and says a lot of that work is helping people achieve clarity on their core values. “Healing patients is a core identify for physicians; we want to take care of people. But other things can get in the way of that, and hospitalist groups can work at minimizing those barriers. We also need to learn, as hospitalists, that we work in a group. You need to be creative in how you do your team building, especially now, when you can no longer get together for dinner. Whatever it is, how do we bring our team back together? The biggest source of support for many hospitalists, beyond their family, is the group.”
Dr. Case said there is a longer-term need to study the root causes of burnout in hospitalists and to identify the issues that cause job stress. “What is modifiable? How can we tackle it? I see that as big part of my job every day. Being a physician is hard enough as it is. Let’s work to resolve those issues that add needlessly to the stress.”
“I think the pandemic brought a magnifying glass to how important a concern staff stress is,” Ms. Panek said. Resilience is important.
“We were working in our group on creating a culture that values trust and transparency, and then the COVID crisis hit,” she said. “But you can still keep working on those things. We would not have been as good or as positive as we were in managing this crisis without that preexisting culture to draw upon. We always said it was important. Now we know that’s true.”
Reference
1. Jones Y et al. Collateral Damage: How COVID-19 Is Adversely Impacting Women Physicians. J Hosp Med. 2020 August;15(8):507-9.
New kinds of job stress multiply in unusual times
New kinds of job stress multiply in unusual times
Clarissa Barnes, MD, a hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and until recently medical director of Avera’s LIGHT Program, a wellness-oriented service for doctors, nurse practitioners, and physician assistants, watched the COVID-19 crisis unfold up close in her community and her hospital. Sioux Falls traced its surge of COVID patients to an outbreak at a local meatpacking plant.
“In the beginning, we didn’t know much about the virus and its communicability, although we have since gotten a better handle on that,” she said. “We had questions: Should we give patients more fluids – or less? Steroids or not? In my experience as a hospitalist I never had patients die every day on my shift, but that was happening with COVID.” The crisis imposed serious stresses on frontline providers, and hospitalists were concerned about personal safety and exposure risk – not just for themselves but for their families.
“The first time I worked on the COVID unit, I moved into the guest room in our home, apart from my husband and our young children,” Dr. Barnes said. “Ultimately I caught the virus, although I have since recovered.” Her experience has highlighted how existing issues of job stress and burnout in hospital medicine have been exacerbated by COVID-19. Even physicians who consider themselves healthy may have little emotional reserve to draw upon in a crisis of this magnitude.
“We are social distancing at work, wearing masks, not eating together with our colleagues – with less camaraderie and social support than we used to have,” she said. “I feel exhausted and there’s no question that my colleagues and I have sacrificed a lot to deal with the pandemic.” Add to that the second front of the COVID-19 crisis, Dr. Barnes said, which is “fighting the medical information wars, trying to correct misinformation put out there by people. Physicians who have been on the front lines of the pandemic know how demoralizing it can be to have people negate your first-hand experience.”
The situation has gotten better in Sioux Falls, Dr. Barnes said, although cases have started rising in the state again. The stress, while not gone, is reduced. For some doctors, “COVID reminded us of why we do what we do. Some of the usual bureaucratic requirements were set aside and we could focus on what our patients needed and how to take care of them.”
Taking job stress seriously
Tiffani Panek, MA, SFHM, CLHM, administrator of the division of hospital medicine at Johns Hopkins Bayview Medical Center in Baltimore, said job stress is a major issue for hospitalist groups.
“We take it seriously here, and use a survey tool to measure morale in our group annually,” she said. “So far, knock on wood, Baltimore has not been one of the big hot spots, but we’ve definitely had waves of COVID patients.”
The Bayview hospitalist group has a diversified set of leaders, including a wellness director. “They’re always checking up on our people, keeping an eye on those who are most vulnerable. One of the stressors we hadn’t thought about before was for our people who live alone. With the isolation and lockdown, they haven’t been able to socialize, so we’ve made direct outreach, asking people how they were doing,” Ms. Panek said. “People know we’ve got their back – professionally and personally. They know, if there’s something we can do to help, we will do it.”
Bayview Medical Center has COVID-specific units and non-COVID units, and has tried to rotate hospitalist assignments because more than a couple days in a row spent wearing full personal protective equipment (PPE) is exhausting, Ms. Panek said. The group also allocated a respite room just outside the biocontainment unit, with a computer and opportunities for providers to just sit and take a breather – with appropriate social distancing. “It’s not fancy, but you just have to wear a mask, not full PPE.”
The Hopkins hospitalist group’s wellness director, Catherine Washburn, MD, also a working hospitalist, said providers are exhausted, and trying to transition to the new normal is a moving target.
“It’s hard for anyone to say what our lives will look like in 6 months,” she said. “People in our group have lost family members to COVID, or postponed major life events, like weddings. We acknowledge losses together as a group, and celebrate things worth celebrating, like babies or birthdays.”
Greatest COVID caseload
Joshua Case, MD, hospitalist medical director for 16 acute care hospitals of Northwell Health serving metropolitan New York City and Long Island, said his group’s hospitalists and other staff worked incredibly hard during the surge of COVID-19 patients in New York. “Northwell likely cared for more COVID patients than any other health care system in the U.S., if not the world.
“It’s vastly different now. We went from a peak of thousands of cases per day down to about 70-90 new cases a day across our system. We’re lucky our system recognized that COVID could be an issue early on, with all of the multifaceted stressors on patient care,” Dr. Case said. “We’ve done whatever we could to give people time off, especially as the census started to come down. We freed up as many supportive mental health services as we could, working with the health system’s employee assistance program.”
Northwell gave out numbers for the psychiatry department, with clinicians available 24/7 for a confidential call, along with outside volunteers and a network of trauma psychologists. “Our system also provided emergency child care for staff, including hospitalists, wherever we could, drawing upon community resources,” Dr. Case added.
“We recognize that we’re all in the same foxhole. That’s been a helpful attitude – recognizing that it’s okay to be upset in a crisis and to have trouble dealing with what’s going on,” he said. “We need to acknowledge that some of us are suffering and try to encourage people to face it head on. For a lot of physicians, especially those who were redeployed here from other departments, it was important just to have us ask if they were doing okay.”
Brian Schroeder, MHA, FACHE, FHM, assistant vice president for hospital and emergency medicine for Atrium Health, based in Charlotte, N.C., said one of the biggest sources of stress on his staff has been the constant pace of change – whether local hospital protocols, state policies, or guidelines from the Centers for Disease Control and Prevention. “The updating is difficult to keep up with. A lot of our physicians get worried and anxious that they’re not following the latest guidelines or correctly doing what they should be doing to care for COVID patients. One thing we’ve done to alleviate some of that fear and anxiety is through weekly huddles with our hospital teams, focusing on changes relevant to their work. We also have weekly ‘all-hands’ meetings for our 250 providers across 13 acute and four postacute facilities.”
Before COVID, it was difficult to get everyone together as one big group from hospitals up to 5 hours apart, but with the Microsoft Teams platform, they can all meet together.
“At the height of the pandemic, we’d convene weekly and share national statistics, organizational statistics, testing updates, changes to protocols,” Mr. Schroeder said. As the pace of change has slowed, these meetings were cut back to monthly. “Our physicians feel we are passing on information as soon as we get it. They know we’ll always tell them what we know.”
Sarah Richards, MD, assistant professor of internal medicine at the University of Nebraska, Omaha, who heads the Society of Hospital Medicine’s Well-Being Task Force, formed to address staff stress in the COVID environment, said there are things that health care systems can do to help mitigate job stress and burnout. But broader issues may need to be addressed at a national level. “SHM is trying to understand work-related stress – and to identify resources that could support doctors, so they can spend more of their time doing what they enjoy most, which is taking care of patients,” she said.
“We also recognize that people have had very different experiences, depending on geography, and at the individual level stressors are experienced very differently,” Dr. Richard noted. “One of the most common stressors we’ve heard from doctors is the challenge of caring for patients who are lonely and isolated in their hospital rooms, suffering and dying in new ways. In low-incidence areas, doctors are expressing guilt because they aren’t under as much stress as their colleagues. In high-incidence areas, doctors are already experiencing posttraumatic stress disorder.”
SHM’s Well-Being Task Force is working on a tool to help normalize these stressors and encourage open conversations about mental health issues. A guide called “HM COVID Check-in Guide for Self & Peers” is designed to help hospitalists break the culture of silence around well-being and burnout during COVID-19 and how people are handling and processing the pandemic experience. It is expected to be completed later this year, Dr. Richards said. Other SHM projects and resources for staff support are also in the works.
The impact on women doctors
In a recent Journal of Hospital Medicine article entitled “Collateral Damage: How COVID-19 is Adversely Impacting Women Physicians,” hospitalist Yemisi Jones, MD, medical director of continuing medical education at Cincinnati Children’s Hospital Medical Center, and colleagues argue that preexisting gender inequities in compensation, academic rank and leadership positions for physicians have made the COVID-19 crisis even more burdensome on female hospitalists.1
“Increased childcare and schooling obligations, coupled with disproportionate household responsibilities and an inability to work from home, will likely result in female hospitalists struggling to meet family needs while pandemic-related work responsibilities are ramping up,” they write. COVID may intensify workplace inequalities, with a lack of recognition of the undue strain that group policies place on women.
“Often women suffer in silence,” said coauthor Jennifer O’Toole, MD, MEd, director of education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center and program director of the internal medicine–pediatrics residency. “We are not always the best self-advocates, although many of us are working on that.”
When women in hospital medicine take leadership roles, these often tend to involve mutual support activities, taking care of colleagues, and promoting collaborative work environments, Dr. Jones added. The stereotypical example is the committee that organizes celebrations when group members get married or have babies.
These activities can take a lot of time, she said. “We need to pay attention to that kind of role in our groups, because it’s important to the cohesiveness of the group. But it often goes unrecognized and doesn’t translate into the currency of promotion and leadership in medicine. When women go for promotions in the future, how will what happened during the COVID crisis impact their opportunities?”
What is the answer to overcoming these systemic inequities? Start with making sure women are part of the leadership team, with responsibilities for group policies, schedules, and other important decisions. “Look at your group’s leadership – particularly the higher positions. If it’s not diverse, ask why. ‘What is it about the structure of our group?’ Make a more concerted effort in your recruitment and retention,” Dr. Jones said.
The JHM article also recommends closely monitoring the direct and indirect effects of COVID-19 on female hospitalists, inquiring specifically about the needs of women in the organization, and ensuring that diversity, inclusion, and equity efforts are not suspended during the pandemic. Gender-based disparities in pay also need a closer look, and not just one time but reviewed periodically and adjusted accordingly.
Mentoring for early career women is important, but more so is sponsorship – someone in a high-level leadership role in the group sponsoring women who are rising up the career ladder, Dr. O’Toole said. “Professional women tend to be overmentored and undersponsored.”
What are the answers?
Ultimately, listening is key to try to help people get through the pandemic, Dr. Washburn said. “People become burned out when they feel leadership doesn’t understand their needs or doesn’t hear their concerns. Our group leaders all do clinical work, so they are seen as one of us. They try very hard; they have listening ears. But listening is just the first step. Next step is to work creatively to get the identified needs met.”
A few years ago, Johns Hopkins developed training in enhanced communication in health care for all hospital providers, including nurses and doctors, encouraging them to get trained in how to actively listen and address their patients’ emotional and social experiences as well as disease, Dr. Washburn explained. Learning how to listen better to patients can enhance skills at listening to colleagues, and vice versa. “We recognize the importance of better communication – for reducing sentinel events in the hospital and also for preventing staff burnout.”
Dr. Barnes also does physician coaching, and says a lot of that work is helping people achieve clarity on their core values. “Healing patients is a core identify for physicians; we want to take care of people. But other things can get in the way of that, and hospitalist groups can work at minimizing those barriers. We also need to learn, as hospitalists, that we work in a group. You need to be creative in how you do your team building, especially now, when you can no longer get together for dinner. Whatever it is, how do we bring our team back together? The biggest source of support for many hospitalists, beyond their family, is the group.”
Dr. Case said there is a longer-term need to study the root causes of burnout in hospitalists and to identify the issues that cause job stress. “What is modifiable? How can we tackle it? I see that as big part of my job every day. Being a physician is hard enough as it is. Let’s work to resolve those issues that add needlessly to the stress.”
“I think the pandemic brought a magnifying glass to how important a concern staff stress is,” Ms. Panek said. Resilience is important.
“We were working in our group on creating a culture that values trust and transparency, and then the COVID crisis hit,” she said. “But you can still keep working on those things. We would not have been as good or as positive as we were in managing this crisis without that preexisting culture to draw upon. We always said it was important. Now we know that’s true.”
Reference
1. Jones Y et al. Collateral Damage: How COVID-19 Is Adversely Impacting Women Physicians. J Hosp Med. 2020 August;15(8):507-9.
Clarissa Barnes, MD, a hospitalist at Avera McKennan Hospital in Sioux Falls, S.D., and until recently medical director of Avera’s LIGHT Program, a wellness-oriented service for doctors, nurse practitioners, and physician assistants, watched the COVID-19 crisis unfold up close in her community and her hospital. Sioux Falls traced its surge of COVID patients to an outbreak at a local meatpacking plant.
“In the beginning, we didn’t know much about the virus and its communicability, although we have since gotten a better handle on that,” she said. “We had questions: Should we give patients more fluids – or less? Steroids or not? In my experience as a hospitalist I never had patients die every day on my shift, but that was happening with COVID.” The crisis imposed serious stresses on frontline providers, and hospitalists were concerned about personal safety and exposure risk – not just for themselves but for their families.
“The first time I worked on the COVID unit, I moved into the guest room in our home, apart from my husband and our young children,” Dr. Barnes said. “Ultimately I caught the virus, although I have since recovered.” Her experience has highlighted how existing issues of job stress and burnout in hospital medicine have been exacerbated by COVID-19. Even physicians who consider themselves healthy may have little emotional reserve to draw upon in a crisis of this magnitude.
“We are social distancing at work, wearing masks, not eating together with our colleagues – with less camaraderie and social support than we used to have,” she said. “I feel exhausted and there’s no question that my colleagues and I have sacrificed a lot to deal with the pandemic.” Add to that the second front of the COVID-19 crisis, Dr. Barnes said, which is “fighting the medical information wars, trying to correct misinformation put out there by people. Physicians who have been on the front lines of the pandemic know how demoralizing it can be to have people negate your first-hand experience.”
The situation has gotten better in Sioux Falls, Dr. Barnes said, although cases have started rising in the state again. The stress, while not gone, is reduced. For some doctors, “COVID reminded us of why we do what we do. Some of the usual bureaucratic requirements were set aside and we could focus on what our patients needed and how to take care of them.”
Taking job stress seriously
Tiffani Panek, MA, SFHM, CLHM, administrator of the division of hospital medicine at Johns Hopkins Bayview Medical Center in Baltimore, said job stress is a major issue for hospitalist groups.
“We take it seriously here, and use a survey tool to measure morale in our group annually,” she said. “So far, knock on wood, Baltimore has not been one of the big hot spots, but we’ve definitely had waves of COVID patients.”
The Bayview hospitalist group has a diversified set of leaders, including a wellness director. “They’re always checking up on our people, keeping an eye on those who are most vulnerable. One of the stressors we hadn’t thought about before was for our people who live alone. With the isolation and lockdown, they haven’t been able to socialize, so we’ve made direct outreach, asking people how they were doing,” Ms. Panek said. “People know we’ve got their back – professionally and personally. They know, if there’s something we can do to help, we will do it.”
Bayview Medical Center has COVID-specific units and non-COVID units, and has tried to rotate hospitalist assignments because more than a couple days in a row spent wearing full personal protective equipment (PPE) is exhausting, Ms. Panek said. The group also allocated a respite room just outside the biocontainment unit, with a computer and opportunities for providers to just sit and take a breather – with appropriate social distancing. “It’s not fancy, but you just have to wear a mask, not full PPE.”
The Hopkins hospitalist group’s wellness director, Catherine Washburn, MD, also a working hospitalist, said providers are exhausted, and trying to transition to the new normal is a moving target.
“It’s hard for anyone to say what our lives will look like in 6 months,” she said. “People in our group have lost family members to COVID, or postponed major life events, like weddings. We acknowledge losses together as a group, and celebrate things worth celebrating, like babies or birthdays.”
Greatest COVID caseload
Joshua Case, MD, hospitalist medical director for 16 acute care hospitals of Northwell Health serving metropolitan New York City and Long Island, said his group’s hospitalists and other staff worked incredibly hard during the surge of COVID-19 patients in New York. “Northwell likely cared for more COVID patients than any other health care system in the U.S., if not the world.
“It’s vastly different now. We went from a peak of thousands of cases per day down to about 70-90 new cases a day across our system. We’re lucky our system recognized that COVID could be an issue early on, with all of the multifaceted stressors on patient care,” Dr. Case said. “We’ve done whatever we could to give people time off, especially as the census started to come down. We freed up as many supportive mental health services as we could, working with the health system’s employee assistance program.”
Northwell gave out numbers for the psychiatry department, with clinicians available 24/7 for a confidential call, along with outside volunteers and a network of trauma psychologists. “Our system also provided emergency child care for staff, including hospitalists, wherever we could, drawing upon community resources,” Dr. Case added.
“We recognize that we’re all in the same foxhole. That’s been a helpful attitude – recognizing that it’s okay to be upset in a crisis and to have trouble dealing with what’s going on,” he said. “We need to acknowledge that some of us are suffering and try to encourage people to face it head on. For a lot of physicians, especially those who were redeployed here from other departments, it was important just to have us ask if they were doing okay.”
Brian Schroeder, MHA, FACHE, FHM, assistant vice president for hospital and emergency medicine for Atrium Health, based in Charlotte, N.C., said one of the biggest sources of stress on his staff has been the constant pace of change – whether local hospital protocols, state policies, or guidelines from the Centers for Disease Control and Prevention. “The updating is difficult to keep up with. A lot of our physicians get worried and anxious that they’re not following the latest guidelines or correctly doing what they should be doing to care for COVID patients. One thing we’ve done to alleviate some of that fear and anxiety is through weekly huddles with our hospital teams, focusing on changes relevant to their work. We also have weekly ‘all-hands’ meetings for our 250 providers across 13 acute and four postacute facilities.”
Before COVID, it was difficult to get everyone together as one big group from hospitals up to 5 hours apart, but with the Microsoft Teams platform, they can all meet together.
“At the height of the pandemic, we’d convene weekly and share national statistics, organizational statistics, testing updates, changes to protocols,” Mr. Schroeder said. As the pace of change has slowed, these meetings were cut back to monthly. “Our physicians feel we are passing on information as soon as we get it. They know we’ll always tell them what we know.”
Sarah Richards, MD, assistant professor of internal medicine at the University of Nebraska, Omaha, who heads the Society of Hospital Medicine’s Well-Being Task Force, formed to address staff stress in the COVID environment, said there are things that health care systems can do to help mitigate job stress and burnout. But broader issues may need to be addressed at a national level. “SHM is trying to understand work-related stress – and to identify resources that could support doctors, so they can spend more of their time doing what they enjoy most, which is taking care of patients,” she said.
“We also recognize that people have had very different experiences, depending on geography, and at the individual level stressors are experienced very differently,” Dr. Richard noted. “One of the most common stressors we’ve heard from doctors is the challenge of caring for patients who are lonely and isolated in their hospital rooms, suffering and dying in new ways. In low-incidence areas, doctors are expressing guilt because they aren’t under as much stress as their colleagues. In high-incidence areas, doctors are already experiencing posttraumatic stress disorder.”
SHM’s Well-Being Task Force is working on a tool to help normalize these stressors and encourage open conversations about mental health issues. A guide called “HM COVID Check-in Guide for Self & Peers” is designed to help hospitalists break the culture of silence around well-being and burnout during COVID-19 and how people are handling and processing the pandemic experience. It is expected to be completed later this year, Dr. Richards said. Other SHM projects and resources for staff support are also in the works.
The impact on women doctors
In a recent Journal of Hospital Medicine article entitled “Collateral Damage: How COVID-19 is Adversely Impacting Women Physicians,” hospitalist Yemisi Jones, MD, medical director of continuing medical education at Cincinnati Children’s Hospital Medical Center, and colleagues argue that preexisting gender inequities in compensation, academic rank and leadership positions for physicians have made the COVID-19 crisis even more burdensome on female hospitalists.1
“Increased childcare and schooling obligations, coupled with disproportionate household responsibilities and an inability to work from home, will likely result in female hospitalists struggling to meet family needs while pandemic-related work responsibilities are ramping up,” they write. COVID may intensify workplace inequalities, with a lack of recognition of the undue strain that group policies place on women.
“Often women suffer in silence,” said coauthor Jennifer O’Toole, MD, MEd, director of education in the division of hospital medicine at Cincinnati Children’s Hospital Medical Center and program director of the internal medicine–pediatrics residency. “We are not always the best self-advocates, although many of us are working on that.”
When women in hospital medicine take leadership roles, these often tend to involve mutual support activities, taking care of colleagues, and promoting collaborative work environments, Dr. Jones added. The stereotypical example is the committee that organizes celebrations when group members get married or have babies.
These activities can take a lot of time, she said. “We need to pay attention to that kind of role in our groups, because it’s important to the cohesiveness of the group. But it often goes unrecognized and doesn’t translate into the currency of promotion and leadership in medicine. When women go for promotions in the future, how will what happened during the COVID crisis impact their opportunities?”
What is the answer to overcoming these systemic inequities? Start with making sure women are part of the leadership team, with responsibilities for group policies, schedules, and other important decisions. “Look at your group’s leadership – particularly the higher positions. If it’s not diverse, ask why. ‘What is it about the structure of our group?’ Make a more concerted effort in your recruitment and retention,” Dr. Jones said.
The JHM article also recommends closely monitoring the direct and indirect effects of COVID-19 on female hospitalists, inquiring specifically about the needs of women in the organization, and ensuring that diversity, inclusion, and equity efforts are not suspended during the pandemic. Gender-based disparities in pay also need a closer look, and not just one time but reviewed periodically and adjusted accordingly.
Mentoring for early career women is important, but more so is sponsorship – someone in a high-level leadership role in the group sponsoring women who are rising up the career ladder, Dr. O’Toole said. “Professional women tend to be overmentored and undersponsored.”
What are the answers?
Ultimately, listening is key to try to help people get through the pandemic, Dr. Washburn said. “People become burned out when they feel leadership doesn’t understand their needs or doesn’t hear their concerns. Our group leaders all do clinical work, so they are seen as one of us. They try very hard; they have listening ears. But listening is just the first step. Next step is to work creatively to get the identified needs met.”
A few years ago, Johns Hopkins developed training in enhanced communication in health care for all hospital providers, including nurses and doctors, encouraging them to get trained in how to actively listen and address their patients’ emotional and social experiences as well as disease, Dr. Washburn explained. Learning how to listen better to patients can enhance skills at listening to colleagues, and vice versa. “We recognize the importance of better communication – for reducing sentinel events in the hospital and also for preventing staff burnout.”
Dr. Barnes also does physician coaching, and says a lot of that work is helping people achieve clarity on their core values. “Healing patients is a core identify for physicians; we want to take care of people. But other things can get in the way of that, and hospitalist groups can work at minimizing those barriers. We also need to learn, as hospitalists, that we work in a group. You need to be creative in how you do your team building, especially now, when you can no longer get together for dinner. Whatever it is, how do we bring our team back together? The biggest source of support for many hospitalists, beyond their family, is the group.”
Dr. Case said there is a longer-term need to study the root causes of burnout in hospitalists and to identify the issues that cause job stress. “What is modifiable? How can we tackle it? I see that as big part of my job every day. Being a physician is hard enough as it is. Let’s work to resolve those issues that add needlessly to the stress.”
“I think the pandemic brought a magnifying glass to how important a concern staff stress is,” Ms. Panek said. Resilience is important.
“We were working in our group on creating a culture that values trust and transparency, and then the COVID crisis hit,” she said. “But you can still keep working on those things. We would not have been as good or as positive as we were in managing this crisis without that preexisting culture to draw upon. We always said it was important. Now we know that’s true.”
Reference
1. Jones Y et al. Collateral Damage: How COVID-19 Is Adversely Impacting Women Physicians. J Hosp Med. 2020 August;15(8):507-9.
‘Soak-and-smear’ AD protocol backed by evidence
The most effective initial step for clearing atopic dermatitis in infants and young children involves daily bathing, followed by immediate application of a moisturizer, topical steroid, or both, according to an expert speaking at the virtual annual Coastal Dermatology Symposium.
“If they are really severe, you can do it twice-daily, but there are several studies that show there is not a huge benefit of twice-daily over once-daily,” said Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland.
He called this technique “soak-and-smear.” The “smear” is performed immediately after the bath when the skin is still damp, he said. When clearing is the goal, and the child has moderate to severe atopic dermatitis (AD), 0.1% triamcinolone or a similar medium potency topical steroid can be applied, and after clearing, the steroid can be switched for a moisturizer, according to Dr. Simpson.
Rather than restricting application to areas of greatest skin involvement, “put it all over,” he advised.
The clearing regimen should be continued “for a couple of more days” after the lesions have resolved, with a return visit in about a week to confirm clearing and reinforce the next steps for keeping patients clear, he added.
The next steps depend on severity. According to Dr. Simpson, severity is defined less by the extent of skin involvement at the baseline examination than the speed at which symptoms return.
For those with only mild symptoms after an extended period of clearing, moisturizer might be sufficient to prevent a significant relapse. For children with a more rapid relapse, it will be necessary to reintroduce topical steroid either every day, every other day, or twice per week.
Whether with moisturizer or with topical steroids, the soak-and-smear technique has now been validated in a recently published crossover randomized trial.
In the trial, children aged 6 months to 11 years, with moderate to severe AD, were randomized to a twice-daily bath, called the “wet method,” versus a twice-weekly bath, called the “dry method.” Both groups received a cleanser and moisturizer along with a low-potency topical steroid as needed.
After 2 weeks, the 40 evaluable patients were crossed over to the opposite bathing technique. The wet, or soak-and-smear approach, was associated with a highly significant reduction in the primary endpoint of SCORing Atopic Dermatitis (SCORAD) index, compared with the dry method (95% confidence interval, 14.9-27.6; P less than .0001). In a secondary analysis, this translated into a 30% relative reduction in favor of the wet method.
In addition, there was improvement in a caregiver assessment of the Atopic Dermatitis Quickscore (ADQ). These data show that “twice-daily baths with topical steroids and moisturizer can help in more moderate to severe population,” said Dr. Simpson, who noted that he has participated in open-label studies with the same soak-and-smear technique that have produced similar results.
Once children are clear, Dr. Simpson recommends a maintenance strategy individualized for severity. In many cases, this will involve moisturizers applied after the bath, supplemented intermittently, such as once or twice per week, with topical steroids. However, if parents find themselves resorting to daily steroids to maintain control, “that’s when you incorporate the TCIs [topical calcineurin inhibitors].”
TCIs “can help you stay at twice-per-week topical steroids,” Dr. Simpson said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
TCIs also help patients avoid steroid withdrawal, a particularly common phenomenon when topical steroids are applied repeatedly to the face. He recommended a proactive approach. By applying TCIs to areas where skin lesions frequently recur, such as the eyelids, flares can often be prevented.
Repeated applications of TCIs “is perfectly safe and effective, and there are many studies that show proactive treatment is very effective and can prevent you from having to use too much topical steroids” or move to a systemic steroid, Dr. Simpson said.
These steps have been highly effective for sustained control even in challenging cases of AD, but he emphasized the importance of explaining the rationale to parents and eliciting their adherence to these treatment steps. Writing out the instructions will reduce confusion and help parents keep their children clear, he added.
Lawrence F. Eichenfield, MD, professor of pediatrics and dermatology at the University of California, San Diego, agreed that this recently published crossover trial has been helpful in counseling parents about how to manage AD in their children.
“Many times, pediatricians tell parents to avoid bathing because they feel that bathing will dry out the skin,” he said. The crossover study, by showing better control of AD with frequent bathing, dispels that notion, although he is not convinced that bathing at this frequency is necessary.
“I have not advised anyone to do twice-daily bathing, with rare exceptions, on the basis on this study, but, basically, I think that whether people do daily bathing or every other day bathing, it is pretty reasonable that bathing might help as long as they are applying moisturizer immediately afterward,” he said.
Dr. Simpson reports financial relationships with AbbVie, Celgene Dermira, Genentech, GlaxoSmithKline, Incyte, Lilly, Medimmune, Pfizer, Regeneron/Sanofi, and Tioga.
This publication and Global Academy for Medical Education are owned by the same parent company.
The most effective initial step for clearing atopic dermatitis in infants and young children involves daily bathing, followed by immediate application of a moisturizer, topical steroid, or both, according to an expert speaking at the virtual annual Coastal Dermatology Symposium.
“If they are really severe, you can do it twice-daily, but there are several studies that show there is not a huge benefit of twice-daily over once-daily,” said Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland.
He called this technique “soak-and-smear.” The “smear” is performed immediately after the bath when the skin is still damp, he said. When clearing is the goal, and the child has moderate to severe atopic dermatitis (AD), 0.1% triamcinolone or a similar medium potency topical steroid can be applied, and after clearing, the steroid can be switched for a moisturizer, according to Dr. Simpson.
Rather than restricting application to areas of greatest skin involvement, “put it all over,” he advised.
The clearing regimen should be continued “for a couple of more days” after the lesions have resolved, with a return visit in about a week to confirm clearing and reinforce the next steps for keeping patients clear, he added.
The next steps depend on severity. According to Dr. Simpson, severity is defined less by the extent of skin involvement at the baseline examination than the speed at which symptoms return.
For those with only mild symptoms after an extended period of clearing, moisturizer might be sufficient to prevent a significant relapse. For children with a more rapid relapse, it will be necessary to reintroduce topical steroid either every day, every other day, or twice per week.
Whether with moisturizer or with topical steroids, the soak-and-smear technique has now been validated in a recently published crossover randomized trial.
In the trial, children aged 6 months to 11 years, with moderate to severe AD, were randomized to a twice-daily bath, called the “wet method,” versus a twice-weekly bath, called the “dry method.” Both groups received a cleanser and moisturizer along with a low-potency topical steroid as needed.
After 2 weeks, the 40 evaluable patients were crossed over to the opposite bathing technique. The wet, or soak-and-smear approach, was associated with a highly significant reduction in the primary endpoint of SCORing Atopic Dermatitis (SCORAD) index, compared with the dry method (95% confidence interval, 14.9-27.6; P less than .0001). In a secondary analysis, this translated into a 30% relative reduction in favor of the wet method.
In addition, there was improvement in a caregiver assessment of the Atopic Dermatitis Quickscore (ADQ). These data show that “twice-daily baths with topical steroids and moisturizer can help in more moderate to severe population,” said Dr. Simpson, who noted that he has participated in open-label studies with the same soak-and-smear technique that have produced similar results.
Once children are clear, Dr. Simpson recommends a maintenance strategy individualized for severity. In many cases, this will involve moisturizers applied after the bath, supplemented intermittently, such as once or twice per week, with topical steroids. However, if parents find themselves resorting to daily steroids to maintain control, “that’s when you incorporate the TCIs [topical calcineurin inhibitors].”
TCIs “can help you stay at twice-per-week topical steroids,” Dr. Simpson said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
TCIs also help patients avoid steroid withdrawal, a particularly common phenomenon when topical steroids are applied repeatedly to the face. He recommended a proactive approach. By applying TCIs to areas where skin lesions frequently recur, such as the eyelids, flares can often be prevented.
Repeated applications of TCIs “is perfectly safe and effective, and there are many studies that show proactive treatment is very effective and can prevent you from having to use too much topical steroids” or move to a systemic steroid, Dr. Simpson said.
These steps have been highly effective for sustained control even in challenging cases of AD, but he emphasized the importance of explaining the rationale to parents and eliciting their adherence to these treatment steps. Writing out the instructions will reduce confusion and help parents keep their children clear, he added.
Lawrence F. Eichenfield, MD, professor of pediatrics and dermatology at the University of California, San Diego, agreed that this recently published crossover trial has been helpful in counseling parents about how to manage AD in their children.
“Many times, pediatricians tell parents to avoid bathing because they feel that bathing will dry out the skin,” he said. The crossover study, by showing better control of AD with frequent bathing, dispels that notion, although he is not convinced that bathing at this frequency is necessary.
“I have not advised anyone to do twice-daily bathing, with rare exceptions, on the basis on this study, but, basically, I think that whether people do daily bathing or every other day bathing, it is pretty reasonable that bathing might help as long as they are applying moisturizer immediately afterward,” he said.
Dr. Simpson reports financial relationships with AbbVie, Celgene Dermira, Genentech, GlaxoSmithKline, Incyte, Lilly, Medimmune, Pfizer, Regeneron/Sanofi, and Tioga.
This publication and Global Academy for Medical Education are owned by the same parent company.
The most effective initial step for clearing atopic dermatitis in infants and young children involves daily bathing, followed by immediate application of a moisturizer, topical steroid, or both, according to an expert speaking at the virtual annual Coastal Dermatology Symposium.
“If they are really severe, you can do it twice-daily, but there are several studies that show there is not a huge benefit of twice-daily over once-daily,” said Eric Simpson, MD, professor of dermatology, Oregon Health & Science University, Portland.
He called this technique “soak-and-smear.” The “smear” is performed immediately after the bath when the skin is still damp, he said. When clearing is the goal, and the child has moderate to severe atopic dermatitis (AD), 0.1% triamcinolone or a similar medium potency topical steroid can be applied, and after clearing, the steroid can be switched for a moisturizer, according to Dr. Simpson.
Rather than restricting application to areas of greatest skin involvement, “put it all over,” he advised.
The clearing regimen should be continued “for a couple of more days” after the lesions have resolved, with a return visit in about a week to confirm clearing and reinforce the next steps for keeping patients clear, he added.
The next steps depend on severity. According to Dr. Simpson, severity is defined less by the extent of skin involvement at the baseline examination than the speed at which symptoms return.
For those with only mild symptoms after an extended period of clearing, moisturizer might be sufficient to prevent a significant relapse. For children with a more rapid relapse, it will be necessary to reintroduce topical steroid either every day, every other day, or twice per week.
Whether with moisturizer or with topical steroids, the soak-and-smear technique has now been validated in a recently published crossover randomized trial.
In the trial, children aged 6 months to 11 years, with moderate to severe AD, were randomized to a twice-daily bath, called the “wet method,” versus a twice-weekly bath, called the “dry method.” Both groups received a cleanser and moisturizer along with a low-potency topical steroid as needed.
After 2 weeks, the 40 evaluable patients were crossed over to the opposite bathing technique. The wet, or soak-and-smear approach, was associated with a highly significant reduction in the primary endpoint of SCORing Atopic Dermatitis (SCORAD) index, compared with the dry method (95% confidence interval, 14.9-27.6; P less than .0001). In a secondary analysis, this translated into a 30% relative reduction in favor of the wet method.
In addition, there was improvement in a caregiver assessment of the Atopic Dermatitis Quickscore (ADQ). These data show that “twice-daily baths with topical steroids and moisturizer can help in more moderate to severe population,” said Dr. Simpson, who noted that he has participated in open-label studies with the same soak-and-smear technique that have produced similar results.
Once children are clear, Dr. Simpson recommends a maintenance strategy individualized for severity. In many cases, this will involve moisturizers applied after the bath, supplemented intermittently, such as once or twice per week, with topical steroids. However, if parents find themselves resorting to daily steroids to maintain control, “that’s when you incorporate the TCIs [topical calcineurin inhibitors].”
TCIs “can help you stay at twice-per-week topical steroids,” Dr. Simpson said at the meeting, jointly presented by the University of Louisville and Global Academy for Medical Education.
TCIs also help patients avoid steroid withdrawal, a particularly common phenomenon when topical steroids are applied repeatedly to the face. He recommended a proactive approach. By applying TCIs to areas where skin lesions frequently recur, such as the eyelids, flares can often be prevented.
Repeated applications of TCIs “is perfectly safe and effective, and there are many studies that show proactive treatment is very effective and can prevent you from having to use too much topical steroids” or move to a systemic steroid, Dr. Simpson said.
These steps have been highly effective for sustained control even in challenging cases of AD, but he emphasized the importance of explaining the rationale to parents and eliciting their adherence to these treatment steps. Writing out the instructions will reduce confusion and help parents keep their children clear, he added.
Lawrence F. Eichenfield, MD, professor of pediatrics and dermatology at the University of California, San Diego, agreed that this recently published crossover trial has been helpful in counseling parents about how to manage AD in their children.
“Many times, pediatricians tell parents to avoid bathing because they feel that bathing will dry out the skin,” he said. The crossover study, by showing better control of AD with frequent bathing, dispels that notion, although he is not convinced that bathing at this frequency is necessary.
“I have not advised anyone to do twice-daily bathing, with rare exceptions, on the basis on this study, but, basically, I think that whether people do daily bathing or every other day bathing, it is pretty reasonable that bathing might help as long as they are applying moisturizer immediately afterward,” he said.
Dr. Simpson reports financial relationships with AbbVie, Celgene Dermira, Genentech, GlaxoSmithKline, Incyte, Lilly, Medimmune, Pfizer, Regeneron/Sanofi, and Tioga.
This publication and Global Academy for Medical Education are owned by the same parent company.
FROM COASTAL DERM
How cannabis-based therapeutics could help fight COVID inflammation
Plagued by false starts, a few dashed hopes, but with perhaps a glimmer of light on the horizon, the race to find an effective treatment for COVID-19 continues. At last count, more than 300 treatments and 200 vaccines were in preclinical or clinical development (not to mention the numerous existing agents that are being evaluated for repurposing).
There is also a renewed interest in cannabinoid therapeutics — in particular, the nonpsychoactive agent cannabidiol (CBD) and the prospect of its modulating inflammatory and other disease-associated clinical indices, including SARS-CoV-2–induced viral load, hyperinflammation, the cytokine storm, and acute respiratory distress syndrome (ARDS).
Long hobbled by regulatory, political, and financial barriers, CBD’s potential ability to knock back COVID-19–related inflammation might just open doors that have been closed for years to CBD researchers.
Why CBD and why now?
CBD and the resulting therapeutics have been plagued by a complicated association with recreational cannabis use. It’s been just 2 years since CBD-based therapeutics moved into mainstream medicine — the US Food and Drug Administration (FDA) approved Epidiolex oral solution for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, and in August, the FDA approved it for tuberous sclerosis complex.
CBD’s mechanism of action has not been fully elucidated, but on the basis of its role in immune responses — well described in research spanning more than two decades — it›s not surprising that cannabinoid researchers have thrown their hats into the COVID-19 drug development ring.
The anti-inflammatory potential of CBD is substantial and appears to be related to the fact that it shares 20 protein targets common to inflammation-related pathways, Jenny Wilkerson, PhD, research assistant professor at the University of Florida School of Pharmacy, Gainesville, Florida, explained to Medscape Medical News.
Among the various trials that are currently recruiting or are underway is one that is slated for completion this fall. CANDIDATE (Cannabidiol for COVID-19 Patients With Mild-to-Moderate COVID-19) is a randomized, controlled, double-blind study led by Brazilian researchers at the University of São Paulo. The study, which began recruitment this past August, enrolled 100 patients, 50 in the active treatment group (who received capsulated CBD 300 mg daily for 14 days plus pharmacologic therapy [antipyretics] and clinical measures) and 50 who received placebo.
The primary outcome is intended to help clarify the potential role of oral CBD for preventing COVID-19 disease progression, modifying disease-associated clinical indices, and modulating inflammatory parameters, such as the cytokine storm, according to lead investigator Jose Alexandre de Souza Crippa, MD, PhD, professor of neuropsychology at the Ribeirao Preto Medical School at the University of São Paulo in Brazil, in the description of the study on clinicaltrials.gov. Crippa declined to provide any additional information about the trial in an email to Medscape Medical News.
Calming or preventing the storm
While Crippa and colleagues wrap up their CBD trial in South America, several North American and Canadian researchers are seeking to clarify and address one of the most therapeutically challenging aspects of SARS-CoV-2 infection — the lung macrophage–orchestrated hyperinflammatory response.
Although hyperinflammation is not unique to SARS-CoV-2 infection, disease severity and COVID-19–related mortality have been linked to this rapid and prolonged surge of inflammatory cytokines (eg, interleukin 6 [IL-6], IL-10, tumor necrosis factors [TNF], and chemokines) and the cytokine storm.
“When you stimulate CB2 receptors (involved in fighting inflammation), you get a release of the same inflammatory cytokines that are involved in COVID,” Cecilia Costiniuk, MD, associate professor and researcher at the Research Institute of the McGill University Health Center, Montreal, Canada, told Medscape Medical News.
“So, if you can act on this receptor, you might be able to reduce the release of those damaging cytokines that are causing ARDS, lung damage, etc,” she explained. Targeting these inflammatory mediators has been a key strategy in research aimed at reducing COVID-19 severity and related mortality, which is where CBD comes into play.
“CBD is a very powerful immune regulator. It keeps the [immune] engine on, but it doesn’t push the gas pedal, and it doesn’t push the brake completely,” Babak Baban, PhD, professor and immunologist at the Dental College of Georgia at Augusta University, told Medscape Medical News.
To explore the effectiveness of CBD in reducing hyperactivated inflammatory reactions, Baban and colleagues examined the potential of CBD to ameliorate ARDS in a murine model. The group divided wild-type male mice into sham, control, and treatment groups.
The sham group received intranasal phosphate buffered saline; the treatment and control groups received a polyriboinosinic:polycytidylic acid (poly I:C) double-stranded RNA analogue (100 mcg daily for 3 days) to simulate the cytokine storm and clinical ARDS symptoms.
Following the second poly I:C dose, the treatment group received CBD 5 mg/kg intraperitoneally every other day for 6 days. The mice were sacrificed on day 8.
The study results, published in July in Cannabis and Cannabinoid Research, first confirmed that the poly I:C model simulated the cytokine storm in ARDS, reducing blood oxygen saturation by as much as 10% (from ±81.6% to ±72.2%).
Intraperitoneally administered CBD appeared to reverse these ARDS-like trends. “We observed a significant improvement in severe lymphopenia, a mild decline in the ratio of neutrophils to T cells, and significant reductions in levels of [inflammatory and immune factors] IL-6, IFN-gamma [interferon gamma], and in TNF-alpha after the second CBD dose,” Baban said.
There was also a marked downregulation in infiltrating neutrophils and macrophages in the lung, leading to partial restoration of lung morphology and structure. The investigators write that this suggests “a counter inflammatory role for CBD to limit ARDS progression.”
Additional findings from a follow-up study published in mid-October “provide strong data that CBD may partially assert its beneficial and protective impact through its regulation of the apelin peptide,” wrote Baban in an email to Medscape Medical News.
“Apelin may also be a reliable biomarker for early diagnosis of ARDS in general, and in COVID-19 in particular,” he wrote.
Questions remain concerning dose response and whether CBD alone or in combination with other phytocannabinoids is more effective for treating COVID-19. Timing is likewise unclear.
Baban explained that as a result of the biphasic nature of COVID-19, the “sweet spot” appears to be just before the innate immune response progresses into an inflammation-driven response and fibrotic lung damage occurs.
But Wilkerson isn’t as convinced. She said that as with a thermostat, the endocannabinoid system needs tweaking to get it in the right place, that is, to achieve immune homeostasis. The COVID cytokine storm is highly unpredictable, she added, saying, “Right now, the timing for controlling the COVID cytokine storm is really a moving target.”
Is safety a concern?
Safety questions are expected to arise, especially in relation to COVID-19. CBD is not risk free, and one size does not fit all. Human CBD studies report gastrointestinal and somnolent effects, as well as drug-drug interactions.
Findings from a recent systematic review of randomized, controlled CBD trials support overall tolerability, suggesting that serious adverse events are rare. Such events are believed to be related to drug-drug interactions rather than to CBD itself. On the flip side, it is nonintoxicating, and there does not appear to be potential for abuse.
“It’s generally well tolerated,” Wilkerson said. “There’ve now been several clinical trials in numerous patient population settings where basically the only time you really start to have issues is where you have patients on very select agents. But this is where a pharmacist would come into play.”
Costiniuk agreed: “Just because it’s cannabis, it doesn’t mean that there’s going to be strange or unusual effects; these people [ie, those with severe COVID-19] are in the hospital and monitored very closely.”
Delving into the weeds: What’s next?
Although non-COVID-19 cannabinoid researchers have encountered regulatory roadblocks, several research groups that have had the prescience to dive in at the right time are gaining momentum.
Baban’s team has connected with one of the nation’s few academic laboratories authorized to work with the SARS-CoV-2 virus and are awaiting protocol approval so that they can reproduce their research, this time using two CBD formulations (injectable and inhaled).
If findings are positive, they will move forward quickly to meet with the FDA, Baban said, adding that the team is also collaborating with two organizations to conduct human clinical trials in hopes of pushing up timing.
The initial article caught the eye of the World Health Organization, which included it in its global literature on the coronavirus resource section.
Israeli researchers have also been quite busy. InnoCan Pharma and Tel Aviv University are collaborating to explore the potential for CBD-loaded exosomes (minute extracellular particles that mediate intracellular communication, including via innate and adaptive immune responses). The group plans to use these loaded exosomes to target and facilitate recovery of COVID-19–damaged lung cells.
From a broader perspective, the prospects for harnessing cannabinoids for immune modulation will be more thoroughly explored in a special issue of Cannabis and Cannabinoid Research, which has extended its current call for papers, studies, abstracts, and conference proceedings until the end of December.
Like many of the therapeutic strategies under investigation for the treatment of COVID-19, studies in CBD may continue to raise more questions than answers.
Still, Wilkerson is optimistic. “Taken together, these studies along with countless others suggest that the complex pharmacophore of Cannabis sativa may hold therapeutic utility to treat lung inflammation, such as what is seen in a COVID-19 cytokine storm,» she told Medscape Medical News. “I’m very excited to see what comes out of the research.”
Baban, Wilkerson, and Costiniuk have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Plagued by false starts, a few dashed hopes, but with perhaps a glimmer of light on the horizon, the race to find an effective treatment for COVID-19 continues. At last count, more than 300 treatments and 200 vaccines were in preclinical or clinical development (not to mention the numerous existing agents that are being evaluated for repurposing).
There is also a renewed interest in cannabinoid therapeutics — in particular, the nonpsychoactive agent cannabidiol (CBD) and the prospect of its modulating inflammatory and other disease-associated clinical indices, including SARS-CoV-2–induced viral load, hyperinflammation, the cytokine storm, and acute respiratory distress syndrome (ARDS).
Long hobbled by regulatory, political, and financial barriers, CBD’s potential ability to knock back COVID-19–related inflammation might just open doors that have been closed for years to CBD researchers.
Why CBD and why now?
CBD and the resulting therapeutics have been plagued by a complicated association with recreational cannabis use. It’s been just 2 years since CBD-based therapeutics moved into mainstream medicine — the US Food and Drug Administration (FDA) approved Epidiolex oral solution for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, and in August, the FDA approved it for tuberous sclerosis complex.
CBD’s mechanism of action has not been fully elucidated, but on the basis of its role in immune responses — well described in research spanning more than two decades — it›s not surprising that cannabinoid researchers have thrown their hats into the COVID-19 drug development ring.
The anti-inflammatory potential of CBD is substantial and appears to be related to the fact that it shares 20 protein targets common to inflammation-related pathways, Jenny Wilkerson, PhD, research assistant professor at the University of Florida School of Pharmacy, Gainesville, Florida, explained to Medscape Medical News.
Among the various trials that are currently recruiting or are underway is one that is slated for completion this fall. CANDIDATE (Cannabidiol for COVID-19 Patients With Mild-to-Moderate COVID-19) is a randomized, controlled, double-blind study led by Brazilian researchers at the University of São Paulo. The study, which began recruitment this past August, enrolled 100 patients, 50 in the active treatment group (who received capsulated CBD 300 mg daily for 14 days plus pharmacologic therapy [antipyretics] and clinical measures) and 50 who received placebo.
The primary outcome is intended to help clarify the potential role of oral CBD for preventing COVID-19 disease progression, modifying disease-associated clinical indices, and modulating inflammatory parameters, such as the cytokine storm, according to lead investigator Jose Alexandre de Souza Crippa, MD, PhD, professor of neuropsychology at the Ribeirao Preto Medical School at the University of São Paulo in Brazil, in the description of the study on clinicaltrials.gov. Crippa declined to provide any additional information about the trial in an email to Medscape Medical News.
Calming or preventing the storm
While Crippa and colleagues wrap up their CBD trial in South America, several North American and Canadian researchers are seeking to clarify and address one of the most therapeutically challenging aspects of SARS-CoV-2 infection — the lung macrophage–orchestrated hyperinflammatory response.
Although hyperinflammation is not unique to SARS-CoV-2 infection, disease severity and COVID-19–related mortality have been linked to this rapid and prolonged surge of inflammatory cytokines (eg, interleukin 6 [IL-6], IL-10, tumor necrosis factors [TNF], and chemokines) and the cytokine storm.
“When you stimulate CB2 receptors (involved in fighting inflammation), you get a release of the same inflammatory cytokines that are involved in COVID,” Cecilia Costiniuk, MD, associate professor and researcher at the Research Institute of the McGill University Health Center, Montreal, Canada, told Medscape Medical News.
“So, if you can act on this receptor, you might be able to reduce the release of those damaging cytokines that are causing ARDS, lung damage, etc,” she explained. Targeting these inflammatory mediators has been a key strategy in research aimed at reducing COVID-19 severity and related mortality, which is where CBD comes into play.
“CBD is a very powerful immune regulator. It keeps the [immune] engine on, but it doesn’t push the gas pedal, and it doesn’t push the brake completely,” Babak Baban, PhD, professor and immunologist at the Dental College of Georgia at Augusta University, told Medscape Medical News.
To explore the effectiveness of CBD in reducing hyperactivated inflammatory reactions, Baban and colleagues examined the potential of CBD to ameliorate ARDS in a murine model. The group divided wild-type male mice into sham, control, and treatment groups.
The sham group received intranasal phosphate buffered saline; the treatment and control groups received a polyriboinosinic:polycytidylic acid (poly I:C) double-stranded RNA analogue (100 mcg daily for 3 days) to simulate the cytokine storm and clinical ARDS symptoms.
Following the second poly I:C dose, the treatment group received CBD 5 mg/kg intraperitoneally every other day for 6 days. The mice were sacrificed on day 8.
The study results, published in July in Cannabis and Cannabinoid Research, first confirmed that the poly I:C model simulated the cytokine storm in ARDS, reducing blood oxygen saturation by as much as 10% (from ±81.6% to ±72.2%).
Intraperitoneally administered CBD appeared to reverse these ARDS-like trends. “We observed a significant improvement in severe lymphopenia, a mild decline in the ratio of neutrophils to T cells, and significant reductions in levels of [inflammatory and immune factors] IL-6, IFN-gamma [interferon gamma], and in TNF-alpha after the second CBD dose,” Baban said.
There was also a marked downregulation in infiltrating neutrophils and macrophages in the lung, leading to partial restoration of lung morphology and structure. The investigators write that this suggests “a counter inflammatory role for CBD to limit ARDS progression.”
Additional findings from a follow-up study published in mid-October “provide strong data that CBD may partially assert its beneficial and protective impact through its regulation of the apelin peptide,” wrote Baban in an email to Medscape Medical News.
“Apelin may also be a reliable biomarker for early diagnosis of ARDS in general, and in COVID-19 in particular,” he wrote.
Questions remain concerning dose response and whether CBD alone or in combination with other phytocannabinoids is more effective for treating COVID-19. Timing is likewise unclear.
Baban explained that as a result of the biphasic nature of COVID-19, the “sweet spot” appears to be just before the innate immune response progresses into an inflammation-driven response and fibrotic lung damage occurs.
But Wilkerson isn’t as convinced. She said that as with a thermostat, the endocannabinoid system needs tweaking to get it in the right place, that is, to achieve immune homeostasis. The COVID cytokine storm is highly unpredictable, she added, saying, “Right now, the timing for controlling the COVID cytokine storm is really a moving target.”
Is safety a concern?
Safety questions are expected to arise, especially in relation to COVID-19. CBD is not risk free, and one size does not fit all. Human CBD studies report gastrointestinal and somnolent effects, as well as drug-drug interactions.
Findings from a recent systematic review of randomized, controlled CBD trials support overall tolerability, suggesting that serious adverse events are rare. Such events are believed to be related to drug-drug interactions rather than to CBD itself. On the flip side, it is nonintoxicating, and there does not appear to be potential for abuse.
“It’s generally well tolerated,” Wilkerson said. “There’ve now been several clinical trials in numerous patient population settings where basically the only time you really start to have issues is where you have patients on very select agents. But this is where a pharmacist would come into play.”
Costiniuk agreed: “Just because it’s cannabis, it doesn’t mean that there’s going to be strange or unusual effects; these people [ie, those with severe COVID-19] are in the hospital and monitored very closely.”
Delving into the weeds: What’s next?
Although non-COVID-19 cannabinoid researchers have encountered regulatory roadblocks, several research groups that have had the prescience to dive in at the right time are gaining momentum.
Baban’s team has connected with one of the nation’s few academic laboratories authorized to work with the SARS-CoV-2 virus and are awaiting protocol approval so that they can reproduce their research, this time using two CBD formulations (injectable and inhaled).
If findings are positive, they will move forward quickly to meet with the FDA, Baban said, adding that the team is also collaborating with two organizations to conduct human clinical trials in hopes of pushing up timing.
The initial article caught the eye of the World Health Organization, which included it in its global literature on the coronavirus resource section.
Israeli researchers have also been quite busy. InnoCan Pharma and Tel Aviv University are collaborating to explore the potential for CBD-loaded exosomes (minute extracellular particles that mediate intracellular communication, including via innate and adaptive immune responses). The group plans to use these loaded exosomes to target and facilitate recovery of COVID-19–damaged lung cells.
From a broader perspective, the prospects for harnessing cannabinoids for immune modulation will be more thoroughly explored in a special issue of Cannabis and Cannabinoid Research, which has extended its current call for papers, studies, abstracts, and conference proceedings until the end of December.
Like many of the therapeutic strategies under investigation for the treatment of COVID-19, studies in CBD may continue to raise more questions than answers.
Still, Wilkerson is optimistic. “Taken together, these studies along with countless others suggest that the complex pharmacophore of Cannabis sativa may hold therapeutic utility to treat lung inflammation, such as what is seen in a COVID-19 cytokine storm,» she told Medscape Medical News. “I’m very excited to see what comes out of the research.”
Baban, Wilkerson, and Costiniuk have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
Plagued by false starts, a few dashed hopes, but with perhaps a glimmer of light on the horizon, the race to find an effective treatment for COVID-19 continues. At last count, more than 300 treatments and 200 vaccines were in preclinical or clinical development (not to mention the numerous existing agents that are being evaluated for repurposing).
There is also a renewed interest in cannabinoid therapeutics — in particular, the nonpsychoactive agent cannabidiol (CBD) and the prospect of its modulating inflammatory and other disease-associated clinical indices, including SARS-CoV-2–induced viral load, hyperinflammation, the cytokine storm, and acute respiratory distress syndrome (ARDS).
Long hobbled by regulatory, political, and financial barriers, CBD’s potential ability to knock back COVID-19–related inflammation might just open doors that have been closed for years to CBD researchers.
Why CBD and why now?
CBD and the resulting therapeutics have been plagued by a complicated association with recreational cannabis use. It’s been just 2 years since CBD-based therapeutics moved into mainstream medicine — the US Food and Drug Administration (FDA) approved Epidiolex oral solution for the treatment of Lennox-Gastaut syndrome and Dravet syndrome, and in August, the FDA approved it for tuberous sclerosis complex.
CBD’s mechanism of action has not been fully elucidated, but on the basis of its role in immune responses — well described in research spanning more than two decades — it›s not surprising that cannabinoid researchers have thrown their hats into the COVID-19 drug development ring.
The anti-inflammatory potential of CBD is substantial and appears to be related to the fact that it shares 20 protein targets common to inflammation-related pathways, Jenny Wilkerson, PhD, research assistant professor at the University of Florida School of Pharmacy, Gainesville, Florida, explained to Medscape Medical News.
Among the various trials that are currently recruiting or are underway is one that is slated for completion this fall. CANDIDATE (Cannabidiol for COVID-19 Patients With Mild-to-Moderate COVID-19) is a randomized, controlled, double-blind study led by Brazilian researchers at the University of São Paulo. The study, which began recruitment this past August, enrolled 100 patients, 50 in the active treatment group (who received capsulated CBD 300 mg daily for 14 days plus pharmacologic therapy [antipyretics] and clinical measures) and 50 who received placebo.
The primary outcome is intended to help clarify the potential role of oral CBD for preventing COVID-19 disease progression, modifying disease-associated clinical indices, and modulating inflammatory parameters, such as the cytokine storm, according to lead investigator Jose Alexandre de Souza Crippa, MD, PhD, professor of neuropsychology at the Ribeirao Preto Medical School at the University of São Paulo in Brazil, in the description of the study on clinicaltrials.gov. Crippa declined to provide any additional information about the trial in an email to Medscape Medical News.
Calming or preventing the storm
While Crippa and colleagues wrap up their CBD trial in South America, several North American and Canadian researchers are seeking to clarify and address one of the most therapeutically challenging aspects of SARS-CoV-2 infection — the lung macrophage–orchestrated hyperinflammatory response.
Although hyperinflammation is not unique to SARS-CoV-2 infection, disease severity and COVID-19–related mortality have been linked to this rapid and prolonged surge of inflammatory cytokines (eg, interleukin 6 [IL-6], IL-10, tumor necrosis factors [TNF], and chemokines) and the cytokine storm.
“When you stimulate CB2 receptors (involved in fighting inflammation), you get a release of the same inflammatory cytokines that are involved in COVID,” Cecilia Costiniuk, MD, associate professor and researcher at the Research Institute of the McGill University Health Center, Montreal, Canada, told Medscape Medical News.
“So, if you can act on this receptor, you might be able to reduce the release of those damaging cytokines that are causing ARDS, lung damage, etc,” she explained. Targeting these inflammatory mediators has been a key strategy in research aimed at reducing COVID-19 severity and related mortality, which is where CBD comes into play.
“CBD is a very powerful immune regulator. It keeps the [immune] engine on, but it doesn’t push the gas pedal, and it doesn’t push the brake completely,” Babak Baban, PhD, professor and immunologist at the Dental College of Georgia at Augusta University, told Medscape Medical News.
To explore the effectiveness of CBD in reducing hyperactivated inflammatory reactions, Baban and colleagues examined the potential of CBD to ameliorate ARDS in a murine model. The group divided wild-type male mice into sham, control, and treatment groups.
The sham group received intranasal phosphate buffered saline; the treatment and control groups received a polyriboinosinic:polycytidylic acid (poly I:C) double-stranded RNA analogue (100 mcg daily for 3 days) to simulate the cytokine storm and clinical ARDS symptoms.
Following the second poly I:C dose, the treatment group received CBD 5 mg/kg intraperitoneally every other day for 6 days. The mice were sacrificed on day 8.
The study results, published in July in Cannabis and Cannabinoid Research, first confirmed that the poly I:C model simulated the cytokine storm in ARDS, reducing blood oxygen saturation by as much as 10% (from ±81.6% to ±72.2%).
Intraperitoneally administered CBD appeared to reverse these ARDS-like trends. “We observed a significant improvement in severe lymphopenia, a mild decline in the ratio of neutrophils to T cells, and significant reductions in levels of [inflammatory and immune factors] IL-6, IFN-gamma [interferon gamma], and in TNF-alpha after the second CBD dose,” Baban said.
There was also a marked downregulation in infiltrating neutrophils and macrophages in the lung, leading to partial restoration of lung morphology and structure. The investigators write that this suggests “a counter inflammatory role for CBD to limit ARDS progression.”
Additional findings from a follow-up study published in mid-October “provide strong data that CBD may partially assert its beneficial and protective impact through its regulation of the apelin peptide,” wrote Baban in an email to Medscape Medical News.
“Apelin may also be a reliable biomarker for early diagnosis of ARDS in general, and in COVID-19 in particular,” he wrote.
Questions remain concerning dose response and whether CBD alone or in combination with other phytocannabinoids is more effective for treating COVID-19. Timing is likewise unclear.
Baban explained that as a result of the biphasic nature of COVID-19, the “sweet spot” appears to be just before the innate immune response progresses into an inflammation-driven response and fibrotic lung damage occurs.
But Wilkerson isn’t as convinced. She said that as with a thermostat, the endocannabinoid system needs tweaking to get it in the right place, that is, to achieve immune homeostasis. The COVID cytokine storm is highly unpredictable, she added, saying, “Right now, the timing for controlling the COVID cytokine storm is really a moving target.”
Is safety a concern?
Safety questions are expected to arise, especially in relation to COVID-19. CBD is not risk free, and one size does not fit all. Human CBD studies report gastrointestinal and somnolent effects, as well as drug-drug interactions.
Findings from a recent systematic review of randomized, controlled CBD trials support overall tolerability, suggesting that serious adverse events are rare. Such events are believed to be related to drug-drug interactions rather than to CBD itself. On the flip side, it is nonintoxicating, and there does not appear to be potential for abuse.
“It’s generally well tolerated,” Wilkerson said. “There’ve now been several clinical trials in numerous patient population settings where basically the only time you really start to have issues is where you have patients on very select agents. But this is where a pharmacist would come into play.”
Costiniuk agreed: “Just because it’s cannabis, it doesn’t mean that there’s going to be strange or unusual effects; these people [ie, those with severe COVID-19] are in the hospital and monitored very closely.”
Delving into the weeds: What’s next?
Although non-COVID-19 cannabinoid researchers have encountered regulatory roadblocks, several research groups that have had the prescience to dive in at the right time are gaining momentum.
Baban’s team has connected with one of the nation’s few academic laboratories authorized to work with the SARS-CoV-2 virus and are awaiting protocol approval so that they can reproduce their research, this time using two CBD formulations (injectable and inhaled).
If findings are positive, they will move forward quickly to meet with the FDA, Baban said, adding that the team is also collaborating with two organizations to conduct human clinical trials in hopes of pushing up timing.
The initial article caught the eye of the World Health Organization, which included it in its global literature on the coronavirus resource section.
Israeli researchers have also been quite busy. InnoCan Pharma and Tel Aviv University are collaborating to explore the potential for CBD-loaded exosomes (minute extracellular particles that mediate intracellular communication, including via innate and adaptive immune responses). The group plans to use these loaded exosomes to target and facilitate recovery of COVID-19–damaged lung cells.
From a broader perspective, the prospects for harnessing cannabinoids for immune modulation will be more thoroughly explored in a special issue of Cannabis and Cannabinoid Research, which has extended its current call for papers, studies, abstracts, and conference proceedings until the end of December.
Like many of the therapeutic strategies under investigation for the treatment of COVID-19, studies in CBD may continue to raise more questions than answers.
Still, Wilkerson is optimistic. “Taken together, these studies along with countless others suggest that the complex pharmacophore of Cannabis sativa may hold therapeutic utility to treat lung inflammation, such as what is seen in a COVID-19 cytokine storm,» she told Medscape Medical News. “I’m very excited to see what comes out of the research.”
Baban, Wilkerson, and Costiniuk have disclosed no relevant financial relationships.
This article first appeared on Medscape.com.
COVID-19: U.S. sets new weekly high in children
the American Academy of Pediatrics announced Nov. 2.
For the week, over 61,000 cases were reported in children, bringing the number of COVID-19 cases for the month of October to nearly 200,000 and the total since the start of the pandemic to over 853,000, the AAP and the Children’s Hospital Association said in their weekly report.
“These numbers reflect a disturbing increase in cases throughout most of the United States in all populations, especially among young adults,” Yvonne Maldonado, MD, chair of the AAP Committee on Infectious Diseases, said in a separate statement. “We are entering a heightened wave of infections around the country. We would encourage family holiday gatherings to be avoided if possible, especially if there are high-risk individuals in the household.”
For the week ending Oct. 29, children represented 13.3% of all cases, possibly constituting a minitrend of stability over the past 3 weeks. For the full length of the pandemic, 11.1% of all COVID-19 cases have occurred in children, although severe illness is much less common: 1.7% of all hospitalizations (data from 24 states and New York City) and 0.06% of all deaths (data from 42 states and New York City), the AAP and CHA report said.
Other data show that 1,134 per 100,000 children in the United States have been infected by the coronavirus, up from 1,053 the previous week, with state rates ranging from 221 per 100,000 in Vermont to 3,321 in North Dakota. In Wyoming, 25.5% of all COVID-19 cases have occurred in children, the highest of any state, while New Jersey has the lowest rate at 4.9%, the AAP/CHA report showed.
In the 10 states making testing data available, children represent the lowest percentage of tests in Iowa (5.0%) and the highest in Indiana (16.9%). Iowa, however, has the highest positivity rate for children at 14.6%, along with Nevada, while West Virginia has the lowest at 3.6%, the AAP and CHA said in the report.
These numbers, however, may not be telling the whole story. “The number of reported COVID-19 cases in children is likely an undercount because children’s symptoms are often mild and they may not be tested for every illness,” the AAP said in its statement.
“We urge policy makers to listen to doctors and public health experts rather than level baseless accusations against them. Physicians, nurses and other health care professionals have put their lives on the line to protect our communities. We can all do our part to protect them, and our communities, by wearing masks, practicing physical distancing, and getting our flu immunizations,” AAP President Sally Goza, MD, said in the AAP statement.
the American Academy of Pediatrics announced Nov. 2.
For the week, over 61,000 cases were reported in children, bringing the number of COVID-19 cases for the month of October to nearly 200,000 and the total since the start of the pandemic to over 853,000, the AAP and the Children’s Hospital Association said in their weekly report.
“These numbers reflect a disturbing increase in cases throughout most of the United States in all populations, especially among young adults,” Yvonne Maldonado, MD, chair of the AAP Committee on Infectious Diseases, said in a separate statement. “We are entering a heightened wave of infections around the country. We would encourage family holiday gatherings to be avoided if possible, especially if there are high-risk individuals in the household.”
For the week ending Oct. 29, children represented 13.3% of all cases, possibly constituting a minitrend of stability over the past 3 weeks. For the full length of the pandemic, 11.1% of all COVID-19 cases have occurred in children, although severe illness is much less common: 1.7% of all hospitalizations (data from 24 states and New York City) and 0.06% of all deaths (data from 42 states and New York City), the AAP and CHA report said.
Other data show that 1,134 per 100,000 children in the United States have been infected by the coronavirus, up from 1,053 the previous week, with state rates ranging from 221 per 100,000 in Vermont to 3,321 in North Dakota. In Wyoming, 25.5% of all COVID-19 cases have occurred in children, the highest of any state, while New Jersey has the lowest rate at 4.9%, the AAP/CHA report showed.
In the 10 states making testing data available, children represent the lowest percentage of tests in Iowa (5.0%) and the highest in Indiana (16.9%). Iowa, however, has the highest positivity rate for children at 14.6%, along with Nevada, while West Virginia has the lowest at 3.6%, the AAP and CHA said in the report.
These numbers, however, may not be telling the whole story. “The number of reported COVID-19 cases in children is likely an undercount because children’s symptoms are often mild and they may not be tested for every illness,” the AAP said in its statement.
“We urge policy makers to listen to doctors and public health experts rather than level baseless accusations against them. Physicians, nurses and other health care professionals have put their lives on the line to protect our communities. We can all do our part to protect them, and our communities, by wearing masks, practicing physical distancing, and getting our flu immunizations,” AAP President Sally Goza, MD, said in the AAP statement.
the American Academy of Pediatrics announced Nov. 2.
For the week, over 61,000 cases were reported in children, bringing the number of COVID-19 cases for the month of October to nearly 200,000 and the total since the start of the pandemic to over 853,000, the AAP and the Children’s Hospital Association said in their weekly report.
“These numbers reflect a disturbing increase in cases throughout most of the United States in all populations, especially among young adults,” Yvonne Maldonado, MD, chair of the AAP Committee on Infectious Diseases, said in a separate statement. “We are entering a heightened wave of infections around the country. We would encourage family holiday gatherings to be avoided if possible, especially if there are high-risk individuals in the household.”
For the week ending Oct. 29, children represented 13.3% of all cases, possibly constituting a minitrend of stability over the past 3 weeks. For the full length of the pandemic, 11.1% of all COVID-19 cases have occurred in children, although severe illness is much less common: 1.7% of all hospitalizations (data from 24 states and New York City) and 0.06% of all deaths (data from 42 states and New York City), the AAP and CHA report said.
Other data show that 1,134 per 100,000 children in the United States have been infected by the coronavirus, up from 1,053 the previous week, with state rates ranging from 221 per 100,000 in Vermont to 3,321 in North Dakota. In Wyoming, 25.5% of all COVID-19 cases have occurred in children, the highest of any state, while New Jersey has the lowest rate at 4.9%, the AAP/CHA report showed.
In the 10 states making testing data available, children represent the lowest percentage of tests in Iowa (5.0%) and the highest in Indiana (16.9%). Iowa, however, has the highest positivity rate for children at 14.6%, along with Nevada, while West Virginia has the lowest at 3.6%, the AAP and CHA said in the report.
These numbers, however, may not be telling the whole story. “The number of reported COVID-19 cases in children is likely an undercount because children’s symptoms are often mild and they may not be tested for every illness,” the AAP said in its statement.
“We urge policy makers to listen to doctors and public health experts rather than level baseless accusations against them. Physicians, nurses and other health care professionals have put their lives on the line to protect our communities. We can all do our part to protect them, and our communities, by wearing masks, practicing physical distancing, and getting our flu immunizations,” AAP President Sally Goza, MD, said in the AAP statement.
Birch bark derivative gel found effective for EB, in phase 3 study
A . The results come from the largest double-blind, randomized trial performed in this patient population.
More than 41% of EB target wounds that were treated with Oleogel-S10 healed within 45 days, compared with about 29% of target wounds treated with placebo, in the EASE phase 3 trial, conducted at 58 sites in 28 countries.
A group of rare genetic disorders, EB “is described as the worst disease you’ve never heard of,” explained lead investigator Dedee Murrell, MD, director of dermatology, St. George Hospital at the University of New South Wales, Sydney. “It starts in children and is like having burns that heal with scars, and no treatment has been approved for it” by the Food and Drug Administration.
“This is the first large clinical trial with placebo of a topical treatment that’s worked for this terrible disease,” Dr. Murrell said in an interview. She noted that standard EB treatment currently consists of applying nonstick dressings to wounds to protect skin from trauma and infection.
Dr. Murrell, who has focused her work on EB patients since 1990, presented the findings at the virtual annual Congress of the European Academy of Dermatology and Venereology.
The trial enrolled 223 patients (average age, 12 years, but ages ranged to 81 years) with three types of EB, including dystrophic and junctional EB and Kindler syndrome. For each participant, a target wound was selected for use as the primary efficacy endpoint. Those wounds had a partial thickness of between 10 cm2 and 50 cm2 and lasted between 21 days and 9 months. Patients were stratified into groups depending on type of EB and size of target wound.
Participants were randomly assigned to receive either Oleogel-S10 (n = 109) or placebo (n = 114). All applied the blinded-study gel to all their wounds at least every 4 days at the time dressings were changed.
The primary endpoint was the percentage of patients whose target wounds completely closed within 45 days. Key secondary endpoints included time to wound healing and percentage of target wounds that healed within 90 days of treatment; incidence and severity of target wound infection; change in total body wound burden, as measured by the Epidermolysis Bullosa Disease Activity and Scarring Index skin activity subscore; change in itching, as measured by the Itch Man Scale and the Leuven Itch Scale; and adverse events.
Nearly 92% of patients who were treated with Oleogel-S10 completed the double-blind phase of the trial, compared with nearly 87% who received placebo. As noted, the primary endpoint was met, with 41.3% of Oleogel-S10 patients achieving target wound closure within 45 days, compared with 28.9% of the patients who received placebo (P = .013).
But the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of Oleogel-S10 patients achieving wound closure vs. 43.9% of control patients.
Target-wound infection occurred in eight participants, including three who used Oleogel-S10 and five who received placebo; all moderate or severe infections occurred in patients who received placebo. Total wound burden was reduced to a greater extent among Oleogel-S10 patients by day 60, but there was no apparent difference at day 90.
Both treatment groups reported qualitative improvements in itch, with no significant differences between groups. The prevalence of adverse events was also similar between groups (Oleogel-S10, 81.7%; placebo, 80.7%). The most frequently reported adverse events among Oleogel-S10 patients, compared with patients who received placebo, were wound complications, pyrexia, wound infection, pruritus, and anemia; only 4.5% of adverse events were deemed severe.
Dr. Murrell said that, on the basis of the trial results, she expects the FDA to fast-track approval of Oleogel-S10, which contains triterpene extract and sunflower oil.
The gel is “a treatment patients will be able to put under their dressings, added to normal treatment, which will accelerate their wound healing, with no significant increase in any side effects,” she added.
Jemima Mellerio, MD, of St. Thomas’ Hospital in London who sees about 400 EB patients each year, agreed with Dr. Murrell that the results are “very exciting.” Dr. Mellerio was not involved in the study.
“Practicing dermatologists seeing people with EB will have something to offer that appears to speed up wound healing in chronic wounds,” Dr. Mellerio said in an interview. “It’s a positive option rather than just supportive treatment, something that makes a difference to the natural history of wounds.”
She said the trial’s biggest strength was including “such a large cohort of patients.
“It’s extremely difficult to do that kind of study, especially with a placebo-controlled arm and especially in a rare disease,” Dr. Mellerio said. “If you think about the product itself, it’s easy to apply, so it’s not particularly onerous for people to add to their daily regimen of dressings.”
The study was funded by Amryt Pharma. Dr. Murrell is an advisory board member for Amryt Pharma. Dr. Mellerio is a consultant for Amryt Pharma.
A version of this article originally appeared on Medscape.com.
A . The results come from the largest double-blind, randomized trial performed in this patient population.
More than 41% of EB target wounds that were treated with Oleogel-S10 healed within 45 days, compared with about 29% of target wounds treated with placebo, in the EASE phase 3 trial, conducted at 58 sites in 28 countries.
A group of rare genetic disorders, EB “is described as the worst disease you’ve never heard of,” explained lead investigator Dedee Murrell, MD, director of dermatology, St. George Hospital at the University of New South Wales, Sydney. “It starts in children and is like having burns that heal with scars, and no treatment has been approved for it” by the Food and Drug Administration.
“This is the first large clinical trial with placebo of a topical treatment that’s worked for this terrible disease,” Dr. Murrell said in an interview. She noted that standard EB treatment currently consists of applying nonstick dressings to wounds to protect skin from trauma and infection.
Dr. Murrell, who has focused her work on EB patients since 1990, presented the findings at the virtual annual Congress of the European Academy of Dermatology and Venereology.
The trial enrolled 223 patients (average age, 12 years, but ages ranged to 81 years) with three types of EB, including dystrophic and junctional EB and Kindler syndrome. For each participant, a target wound was selected for use as the primary efficacy endpoint. Those wounds had a partial thickness of between 10 cm2 and 50 cm2 and lasted between 21 days and 9 months. Patients were stratified into groups depending on type of EB and size of target wound.
Participants were randomly assigned to receive either Oleogel-S10 (n = 109) or placebo (n = 114). All applied the blinded-study gel to all their wounds at least every 4 days at the time dressings were changed.
The primary endpoint was the percentage of patients whose target wounds completely closed within 45 days. Key secondary endpoints included time to wound healing and percentage of target wounds that healed within 90 days of treatment; incidence and severity of target wound infection; change in total body wound burden, as measured by the Epidermolysis Bullosa Disease Activity and Scarring Index skin activity subscore; change in itching, as measured by the Itch Man Scale and the Leuven Itch Scale; and adverse events.
Nearly 92% of patients who were treated with Oleogel-S10 completed the double-blind phase of the trial, compared with nearly 87% who received placebo. As noted, the primary endpoint was met, with 41.3% of Oleogel-S10 patients achieving target wound closure within 45 days, compared with 28.9% of the patients who received placebo (P = .013).
But the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of Oleogel-S10 patients achieving wound closure vs. 43.9% of control patients.
Target-wound infection occurred in eight participants, including three who used Oleogel-S10 and five who received placebo; all moderate or severe infections occurred in patients who received placebo. Total wound burden was reduced to a greater extent among Oleogel-S10 patients by day 60, but there was no apparent difference at day 90.
Both treatment groups reported qualitative improvements in itch, with no significant differences between groups. The prevalence of adverse events was also similar between groups (Oleogel-S10, 81.7%; placebo, 80.7%). The most frequently reported adverse events among Oleogel-S10 patients, compared with patients who received placebo, were wound complications, pyrexia, wound infection, pruritus, and anemia; only 4.5% of adverse events were deemed severe.
Dr. Murrell said that, on the basis of the trial results, she expects the FDA to fast-track approval of Oleogel-S10, which contains triterpene extract and sunflower oil.
The gel is “a treatment patients will be able to put under their dressings, added to normal treatment, which will accelerate their wound healing, with no significant increase in any side effects,” she added.
Jemima Mellerio, MD, of St. Thomas’ Hospital in London who sees about 400 EB patients each year, agreed with Dr. Murrell that the results are “very exciting.” Dr. Mellerio was not involved in the study.
“Practicing dermatologists seeing people with EB will have something to offer that appears to speed up wound healing in chronic wounds,” Dr. Mellerio said in an interview. “It’s a positive option rather than just supportive treatment, something that makes a difference to the natural history of wounds.”
She said the trial’s biggest strength was including “such a large cohort of patients.
“It’s extremely difficult to do that kind of study, especially with a placebo-controlled arm and especially in a rare disease,” Dr. Mellerio said. “If you think about the product itself, it’s easy to apply, so it’s not particularly onerous for people to add to their daily regimen of dressings.”
The study was funded by Amryt Pharma. Dr. Murrell is an advisory board member for Amryt Pharma. Dr. Mellerio is a consultant for Amryt Pharma.
A version of this article originally appeared on Medscape.com.
A . The results come from the largest double-blind, randomized trial performed in this patient population.
More than 41% of EB target wounds that were treated with Oleogel-S10 healed within 45 days, compared with about 29% of target wounds treated with placebo, in the EASE phase 3 trial, conducted at 58 sites in 28 countries.
A group of rare genetic disorders, EB “is described as the worst disease you’ve never heard of,” explained lead investigator Dedee Murrell, MD, director of dermatology, St. George Hospital at the University of New South Wales, Sydney. “It starts in children and is like having burns that heal with scars, and no treatment has been approved for it” by the Food and Drug Administration.
“This is the first large clinical trial with placebo of a topical treatment that’s worked for this terrible disease,” Dr. Murrell said in an interview. She noted that standard EB treatment currently consists of applying nonstick dressings to wounds to protect skin from trauma and infection.
Dr. Murrell, who has focused her work on EB patients since 1990, presented the findings at the virtual annual Congress of the European Academy of Dermatology and Venereology.
The trial enrolled 223 patients (average age, 12 years, but ages ranged to 81 years) with three types of EB, including dystrophic and junctional EB and Kindler syndrome. For each participant, a target wound was selected for use as the primary efficacy endpoint. Those wounds had a partial thickness of between 10 cm2 and 50 cm2 and lasted between 21 days and 9 months. Patients were stratified into groups depending on type of EB and size of target wound.
Participants were randomly assigned to receive either Oleogel-S10 (n = 109) or placebo (n = 114). All applied the blinded-study gel to all their wounds at least every 4 days at the time dressings were changed.
The primary endpoint was the percentage of patients whose target wounds completely closed within 45 days. Key secondary endpoints included time to wound healing and percentage of target wounds that healed within 90 days of treatment; incidence and severity of target wound infection; change in total body wound burden, as measured by the Epidermolysis Bullosa Disease Activity and Scarring Index skin activity subscore; change in itching, as measured by the Itch Man Scale and the Leuven Itch Scale; and adverse events.
Nearly 92% of patients who were treated with Oleogel-S10 completed the double-blind phase of the trial, compared with nearly 87% who received placebo. As noted, the primary endpoint was met, with 41.3% of Oleogel-S10 patients achieving target wound closure within 45 days, compared with 28.9% of the patients who received placebo (P = .013).
But the difference in time to wound healing by day 90 between the two patient groups was not statistically significant (P = .302), with 50.5% of Oleogel-S10 patients achieving wound closure vs. 43.9% of control patients.
Target-wound infection occurred in eight participants, including three who used Oleogel-S10 and five who received placebo; all moderate or severe infections occurred in patients who received placebo. Total wound burden was reduced to a greater extent among Oleogel-S10 patients by day 60, but there was no apparent difference at day 90.
Both treatment groups reported qualitative improvements in itch, with no significant differences between groups. The prevalence of adverse events was also similar between groups (Oleogel-S10, 81.7%; placebo, 80.7%). The most frequently reported adverse events among Oleogel-S10 patients, compared with patients who received placebo, were wound complications, pyrexia, wound infection, pruritus, and anemia; only 4.5% of adverse events were deemed severe.
Dr. Murrell said that, on the basis of the trial results, she expects the FDA to fast-track approval of Oleogel-S10, which contains triterpene extract and sunflower oil.
The gel is “a treatment patients will be able to put under their dressings, added to normal treatment, which will accelerate their wound healing, with no significant increase in any side effects,” she added.
Jemima Mellerio, MD, of St. Thomas’ Hospital in London who sees about 400 EB patients each year, agreed with Dr. Murrell that the results are “very exciting.” Dr. Mellerio was not involved in the study.
“Practicing dermatologists seeing people with EB will have something to offer that appears to speed up wound healing in chronic wounds,” Dr. Mellerio said in an interview. “It’s a positive option rather than just supportive treatment, something that makes a difference to the natural history of wounds.”
She said the trial’s biggest strength was including “such a large cohort of patients.
“It’s extremely difficult to do that kind of study, especially with a placebo-controlled arm and especially in a rare disease,” Dr. Mellerio said. “If you think about the product itself, it’s easy to apply, so it’s not particularly onerous for people to add to their daily regimen of dressings.”
The study was funded by Amryt Pharma. Dr. Murrell is an advisory board member for Amryt Pharma. Dr. Mellerio is a consultant for Amryt Pharma.
A version of this article originally appeared on Medscape.com.
Let side effects guide treatment choice for refractory OCD
Choosing the most effective treatment for patients with obsessive-compulsive disorder requires flexibility and agility on the part of clinicians, according to Wayne K. Goodman, MD.
“There are no data at this point to suggest that one SSRI is superior to another. It’s really dealer’s choice, and it has to do with really picking medications based upon side effects,” Dr. Goodman said at the Psychopharmacology Update, presented by Current Psychiatry and Global Academy for Medical Education. Clinicians can use family history as a guide, he noted, but pharmacogenetic testing has not been helpful in his experience for selection or dosing of an SSRI.
SSRIs, such as fluvoxamine, are one of two mainstays of treatment for patients with obsessive-compulsive disorder (OCD). The other drug class is serotonin reuptake inhibitors, which include medications such clomipramine. Cognitive-behavioral therapy options, such as Exposure and Response Prevention therapy, also has some, albeit limited, efficacy.
Meanwhile, Dr. Goodman said, antidepressant classes other than SRIs and SSRIs have not been effective in treating obsessive-compulsive symptoms, and some patients do not adhere well to cognitive-behavioral therapy, said Dr. Goodman, who is the D.C. and Irene Ellwood Professor in the department of psychiatry and behavioral sciences at Baylor College of Medicine, Houston.
Choosing the most effective treatment for patients with obsessive-compulsive disorder requires flexibility and agility on the part of clinicians, according to Wayne K. Goodman, MD.
“There are no data at this point to suggest that one SSRI is superior to another. It’s really dealer’s choice, and it has to do with really picking medications based upon side effects,” Dr. Goodman said at the Psychopharmacology Update, presented by Current Psychiatry and Global Academy for Medical Education. Clinicians can use family history as a guide, he noted, but pharmacogenetic testing has not been helpful in his experience for selection or dosing of an SSRI.
SSRIs, such as fluvoxamine, are one of two mainstays of treatment for patients with obsessive-compulsive disorder (OCD). The other drug class is serotonin reuptake inhibitors, which include medications such clomipramine. Cognitive-behavioral therapy options, such as Exposure and Response Prevention therapy, also has some, albeit limited, efficacy.
Meanwhile, Dr. Goodman said, antidepressant classes other than SRIs and SSRIs have not been effective in treating obsessive-compulsive symptoms, and some patients do not adhere well to cognitive-behavioral therapy, said Dr. Goodman, who is the D.C. and Irene Ellwood Professor in the department of psychiatry and behavioral sciences at Baylor College of Medicine, Houston.
Choosing the most effective treatment for patients with obsessive-compulsive disorder requires flexibility and agility on the part of clinicians, according to Wayne K. Goodman, MD.
“There are no data at this point to suggest that one SSRI is superior to another. It’s really dealer’s choice, and it has to do with really picking medications based upon side effects,” Dr. Goodman said at the Psychopharmacology Update, presented by Current Psychiatry and Global Academy for Medical Education. Clinicians can use family history as a guide, he noted, but pharmacogenetic testing has not been helpful in his experience for selection or dosing of an SSRI.
SSRIs, such as fluvoxamine, are one of two mainstays of treatment for patients with obsessive-compulsive disorder (OCD). The other drug class is serotonin reuptake inhibitors, which include medications such clomipramine. Cognitive-behavioral therapy options, such as Exposure and Response Prevention therapy, also has some, albeit limited, efficacy.
Meanwhile, Dr. Goodman said, antidepressant classes other than SRIs and SSRIs have not been effective in treating obsessive-compulsive symptoms, and some patients do not adhere well to cognitive-behavioral therapy, said Dr. Goodman, who is the D.C. and Irene Ellwood Professor in the department of psychiatry and behavioral sciences at Baylor College of Medicine, Houston.
FROM PSYCHOPHARMACOLOGY UPDATE
Early results ‘encouraging’ for CAR NKT cells in neuroblastoma
, according to results of an ongoing phase 1 trial.
In one of three patients treated thus far, the CAR NKT cells induced an objective response with regression of a metastatic bone lesion.
Andras Heczey, MD, of Baylor College of Medicine, Houston, and colleagues reported outcomes for the first three patients in Nature Medicine.
The three boys – two 12-year-olds and one 6-year-old – had relapsed/refractory neuroblastoma.
NKT cells were collected from the patients, then genetically engineered to express a CAR to recognize the GD2-ganglioside expressed in neuroblastomas and also to express interleukin-15, which supports NKT cell survival. The cells were expanded and reinfused back into the patients.
The initial results suggest that CAR NKT cells can be used safely to treat neuroblastomas and perhaps other solid tumors, investigators said.
‘A significant advance’ if confirmed
Treating solid tumors with CAR T cells has been a challenge, in part because of inefficient trafficking into tumors.
However, NKT cells naturally migrate to tumors in response to tumor-derived chemokines, Dr. Heczey and colleagues noted. NKT cells kill macrophages associated with tumor growth and promote NK- and T-cell–mediated antitumor responses.
“We decided to leverage this intrinsic property of NKTs and to arm them with an additional bullet – the so-called CAR – to further potentiate their capacity to destroy the tumor,” investigator Gianpietro Dotti, MD, of the University of North Carolina Lindberger Comprehensive Cancer Center in Chapel Hill, said in a press release.
Overall, the “results are very encouraging and, if confirmed in a larger cohort of patients, present a significant advance in the cell therapy field for solid tumors,” said CAR-T researcher Stephen Gottschalk, MD, of St. Jude Children’s Research Hospital in Memphis, Tenn., when asked for comment.
Treatment, safety, and efficacy details
NKT cells are infrequent in human peripheral blood, so the investigators stimulated the NKT cells collected from patients with alpha-galactosylceramide–pulsed irradiated peripheral blood mononuclear cells.
The final products reached a mean NKT cell purity of 95%. The proportion of cells positive for the GD2-CAR ranged from 20% to 70% across the three patients.
After lymphodepletion with cyclophosphamide/fludarabine, the patients were infused with 3 × 106 CAR NKT cells/m2.
The cells were well tolerated, with no dose-limiting toxicities. There were grade 3/4 adverse events, but they occurred before CAR NKT-cell infusion and were thought to be related to lymphodepletion.
NKT-cell frequency and absolute numbers increased in the peripheral blood over baseline and remained elevated at the week 4 assessment.
Two patients had stable disease at 4 weeks, but one had a partial response and a change in Curie score from 2 to 1. The patient’s SPECT- and MIBG-merged scans “revealed a dramatic reduction in the size and MIBG uptake of a bone metastasis. The patient consequently received salvage therapy and achieved a complete response that lasted approximately 6 months,” the investigators noted.
The team found higher percentages of CAR NKT cells in primary tumor and metastatic bone marrow biopsies than in peripheral blood. A high percentage of CAR NKT cells from the tumor specimen, but only a small fraction from the bone metastasis, expressed the GD2-CAR.
This research was funded by Kuur Therapeutics, Alex’s Lemonade Stand Foundation for Childhood Cancer, the American Cancer Society, Cookies for Kids’ Cancer Foundation, and the Cancer Prevention and Research Institute of Texas. Dr. Heczey, Dr. Dotti, and two other researchers are coinventors on pending patent applications for NKT cells in cancer immunotherapy that have been licensed to Kuur Therapeutics for commercial development. Dr. Gottschalk has patent applications in the fields of T-cell and/or gene therapy for cancer. He has relationships with TESSA Therapeutics, Immatics, and Tidal.
SOURCE: Heczey A et al. Nat Med. 2020 Oct 12. doi: 10.1038/s41591-020-1074-2.
, according to results of an ongoing phase 1 trial.
In one of three patients treated thus far, the CAR NKT cells induced an objective response with regression of a metastatic bone lesion.
Andras Heczey, MD, of Baylor College of Medicine, Houston, and colleagues reported outcomes for the first three patients in Nature Medicine.
The three boys – two 12-year-olds and one 6-year-old – had relapsed/refractory neuroblastoma.
NKT cells were collected from the patients, then genetically engineered to express a CAR to recognize the GD2-ganglioside expressed in neuroblastomas and also to express interleukin-15, which supports NKT cell survival. The cells were expanded and reinfused back into the patients.
The initial results suggest that CAR NKT cells can be used safely to treat neuroblastomas and perhaps other solid tumors, investigators said.
‘A significant advance’ if confirmed
Treating solid tumors with CAR T cells has been a challenge, in part because of inefficient trafficking into tumors.
However, NKT cells naturally migrate to tumors in response to tumor-derived chemokines, Dr. Heczey and colleagues noted. NKT cells kill macrophages associated with tumor growth and promote NK- and T-cell–mediated antitumor responses.
“We decided to leverage this intrinsic property of NKTs and to arm them with an additional bullet – the so-called CAR – to further potentiate their capacity to destroy the tumor,” investigator Gianpietro Dotti, MD, of the University of North Carolina Lindberger Comprehensive Cancer Center in Chapel Hill, said in a press release.
Overall, the “results are very encouraging and, if confirmed in a larger cohort of patients, present a significant advance in the cell therapy field for solid tumors,” said CAR-T researcher Stephen Gottschalk, MD, of St. Jude Children’s Research Hospital in Memphis, Tenn., when asked for comment.
Treatment, safety, and efficacy details
NKT cells are infrequent in human peripheral blood, so the investigators stimulated the NKT cells collected from patients with alpha-galactosylceramide–pulsed irradiated peripheral blood mononuclear cells.
The final products reached a mean NKT cell purity of 95%. The proportion of cells positive for the GD2-CAR ranged from 20% to 70% across the three patients.
After lymphodepletion with cyclophosphamide/fludarabine, the patients were infused with 3 × 106 CAR NKT cells/m2.
The cells were well tolerated, with no dose-limiting toxicities. There were grade 3/4 adverse events, but they occurred before CAR NKT-cell infusion and were thought to be related to lymphodepletion.
NKT-cell frequency and absolute numbers increased in the peripheral blood over baseline and remained elevated at the week 4 assessment.
Two patients had stable disease at 4 weeks, but one had a partial response and a change in Curie score from 2 to 1. The patient’s SPECT- and MIBG-merged scans “revealed a dramatic reduction in the size and MIBG uptake of a bone metastasis. The patient consequently received salvage therapy and achieved a complete response that lasted approximately 6 months,” the investigators noted.
The team found higher percentages of CAR NKT cells in primary tumor and metastatic bone marrow biopsies than in peripheral blood. A high percentage of CAR NKT cells from the tumor specimen, but only a small fraction from the bone metastasis, expressed the GD2-CAR.
This research was funded by Kuur Therapeutics, Alex’s Lemonade Stand Foundation for Childhood Cancer, the American Cancer Society, Cookies for Kids’ Cancer Foundation, and the Cancer Prevention and Research Institute of Texas. Dr. Heczey, Dr. Dotti, and two other researchers are coinventors on pending patent applications for NKT cells in cancer immunotherapy that have been licensed to Kuur Therapeutics for commercial development. Dr. Gottschalk has patent applications in the fields of T-cell and/or gene therapy for cancer. He has relationships with TESSA Therapeutics, Immatics, and Tidal.
SOURCE: Heczey A et al. Nat Med. 2020 Oct 12. doi: 10.1038/s41591-020-1074-2.
, according to results of an ongoing phase 1 trial.
In one of three patients treated thus far, the CAR NKT cells induced an objective response with regression of a metastatic bone lesion.
Andras Heczey, MD, of Baylor College of Medicine, Houston, and colleagues reported outcomes for the first three patients in Nature Medicine.
The three boys – two 12-year-olds and one 6-year-old – had relapsed/refractory neuroblastoma.
NKT cells were collected from the patients, then genetically engineered to express a CAR to recognize the GD2-ganglioside expressed in neuroblastomas and also to express interleukin-15, which supports NKT cell survival. The cells were expanded and reinfused back into the patients.
The initial results suggest that CAR NKT cells can be used safely to treat neuroblastomas and perhaps other solid tumors, investigators said.
‘A significant advance’ if confirmed
Treating solid tumors with CAR T cells has been a challenge, in part because of inefficient trafficking into tumors.
However, NKT cells naturally migrate to tumors in response to tumor-derived chemokines, Dr. Heczey and colleagues noted. NKT cells kill macrophages associated with tumor growth and promote NK- and T-cell–mediated antitumor responses.
“We decided to leverage this intrinsic property of NKTs and to arm them with an additional bullet – the so-called CAR – to further potentiate their capacity to destroy the tumor,” investigator Gianpietro Dotti, MD, of the University of North Carolina Lindberger Comprehensive Cancer Center in Chapel Hill, said in a press release.
Overall, the “results are very encouraging and, if confirmed in a larger cohort of patients, present a significant advance in the cell therapy field for solid tumors,” said CAR-T researcher Stephen Gottschalk, MD, of St. Jude Children’s Research Hospital in Memphis, Tenn., when asked for comment.
Treatment, safety, and efficacy details
NKT cells are infrequent in human peripheral blood, so the investigators stimulated the NKT cells collected from patients with alpha-galactosylceramide–pulsed irradiated peripheral blood mononuclear cells.
The final products reached a mean NKT cell purity of 95%. The proportion of cells positive for the GD2-CAR ranged from 20% to 70% across the three patients.
After lymphodepletion with cyclophosphamide/fludarabine, the patients were infused with 3 × 106 CAR NKT cells/m2.
The cells were well tolerated, with no dose-limiting toxicities. There were grade 3/4 adverse events, but they occurred before CAR NKT-cell infusion and were thought to be related to lymphodepletion.
NKT-cell frequency and absolute numbers increased in the peripheral blood over baseline and remained elevated at the week 4 assessment.
Two patients had stable disease at 4 weeks, but one had a partial response and a change in Curie score from 2 to 1. The patient’s SPECT- and MIBG-merged scans “revealed a dramatic reduction in the size and MIBG uptake of a bone metastasis. The patient consequently received salvage therapy and achieved a complete response that lasted approximately 6 months,” the investigators noted.
The team found higher percentages of CAR NKT cells in primary tumor and metastatic bone marrow biopsies than in peripheral blood. A high percentage of CAR NKT cells from the tumor specimen, but only a small fraction from the bone metastasis, expressed the GD2-CAR.
This research was funded by Kuur Therapeutics, Alex’s Lemonade Stand Foundation for Childhood Cancer, the American Cancer Society, Cookies for Kids’ Cancer Foundation, and the Cancer Prevention and Research Institute of Texas. Dr. Heczey, Dr. Dotti, and two other researchers are coinventors on pending patent applications for NKT cells in cancer immunotherapy that have been licensed to Kuur Therapeutics for commercial development. Dr. Gottschalk has patent applications in the fields of T-cell and/or gene therapy for cancer. He has relationships with TESSA Therapeutics, Immatics, and Tidal.
SOURCE: Heczey A et al. Nat Med. 2020 Oct 12. doi: 10.1038/s41591-020-1074-2.
FROM NATURE MEDICINE
HF an added risk in COVID-19, regardless of ejection fraction
People with a history of heart failure – no matter the type – face more complications and death than their peers without HF once hospitalized with COVID-19, a new observational study shows.
A history of HF was associated with a near doubling risk of in-hospital mortality and ICU care and more than a tripling risk of mechanical ventilation despite adjustment for 18 factors including race, obesity, diabetes, previous treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors, and severity of illness.
Adverse outcomes were high regardless of whether patients had HF with a preserved, mid-range, or reduced left ventricular ejection fraction (HFpEF/HFmrEF/HFrEF).
“That for me was the real zinger,” senior author Anuradha Lala, MD, said in an interview . “Because as clinicians, oftentimes, and wrongly so, we think this person has preserved ejection fraction, so they’re not needing my heart failure expertise as much as someone with heart failure with reduced ejection fraction.”
In the peak of the pandemic, that may have meant triaging patients with HFpEF to a regular floor, whereas those with HFrEF were seen by the specialist team.
“What this alerted me to is to take heart failure as a diagnosis very seriously, regardless of ejection fraction, and that is very much in line with all of the emerging data about heart failure with preserved ejection fraction,” said Dr. Lala, from the Icahn School of Medicine at Mount Sinai, New York.
“Now when I see patients in the clinic, I incorporate part of our visit to talking about what they are doing to prevent COVID, which I really wasn’t doing before. It was like ‘Oh yeah, what crazy times we’re dealing with’ and then addressing their heart failure as I normally would,” she said. “But now, interwoven into every visit is: Are you wearing a mask, what’s your social distancing policy, who are you living with at home, has anyone at home or who you’ve interacted with been sick? I’m asking those questions just as a knee-jerk reaction for these patients because I know the repercussions. We have to keep in mind these are observational studies, so I can’t prove causality but these are observations that are, nonetheless, quite robust.”
Although cardiovascular disease, including HF, is recognized as a risk factor for worse outcomes in COVID-19 patients, data are sparse on the clinical course and prognosis of patients with preexisting HF.
“I would have expected that there would have been a gradation of risk from the people with very low ejection fractions up into the normal range, but here it didn’t seem to matter at all. So that’s an important point that bad outcomes were independent of ejection fraction,” commented Lee Goldberg, MD, professor of medicine and chief of advanced heart failure and cardiac transplant at the University of Pennsylvania, Philadelphia.
The study also validated that there is no association between use of RAAS inhibitors and bad outcomes in patients with COVID-19, he said.
Although this has been demonstrated in several studies, concerns were raised early in the pandemic that ACE inhibitors and angiotensin receptor blockers could facilitate infection with SARS-CoV-2 and increase the risk of severe or lethal COVID-19.
“For most clinicians that question has been put to bed, but we’re still getting patients that will ask during office visits ‘Is it safe for me to stay on?’ They still have that doubt [about] ‘Are we doing the right thing?’ ” Dr. Goldberg said.
“We can reassure them now. A lot of us are able to say there’s nothing to that, we’re very clear about this, stay on the meds. If anything, there’s data that suggest actually it may be better to be on an ACE inhibitor; that the hospitalizations were shorter and the outcomes were a little bit better.”
For the current study, published online Oct. 28 in the Journal of the American College of Cardiology, the investigators analyzed 6,439 patients admitted for COVID-19 at one of five Mount Sinai Health System hospitals in New York between Feb. 27 and June 26. Their mean age was 65.3 years, 45% were women, and one-third were treated with RAAS inhibitors before admission.
Using ICD-9/10 codes and individual chart review, HF was identified in 422 patients (6.6%), of which 250 patients had HFpEF (≥50%), 44 had HFmrEF (41%-49%), and 128 had HFrEF (≤40%).
Patients with HFpEF were older, more frequently women with a higher body mass index and history of lung disease than patients with HFrEF, whereas those with HFmrEF fell in between.
The HFpEF group was also treated with hydroxychloroquine or macrolides and noninvasive ventilation more frequently than the other two groups, whereas antiplatelet and neurohormonal therapies were more common in the HFrEF group.
Patients with a history of HF had significantly longer hospital stays than those without HF (8 days vs. 6 days), increased need for intubation (22.8% vs. 11.9%) and ICU care (23.2% vs. 16.6%), and worse in-hospital mortality (40% vs. 24.9%).
After multivariable regression adjustment, HF persisted as an independent risk factor for ICU care (odds ratio, 1.71; 95% CI, 1.25-2.34), intubation and mechanical ventilation (OR, 3.64; 95% CI, 2.56-5.16), and in-hospital mortality (OR, 1.88; 95% CI, 1.27-2.78).
“I knew to expect higher rates of adverse outcomes but I didn’t expect it to be nearly a twofold increase,” Dr. Lala said. “I thought that was pretty powerful.”
No significant differences were seen across LVEF categories in length of stay, need for ICU care, intubation and mechanical ventilation, acute kidney injury, shock, thromboembolic events, arrhythmias, or 30-day readmission rates.
However, cardiogenic shock (7.8% vs. 2.3% vs. 2%) and HF-related causes for 30-day readmissions (47.1% vs. 0% vs. 8.6%) were significantly higher in patients with HFrEF than in those with HFmrEF or HFpEF.
Also, mortality was lower in those with HFmrEF (22.7%) than with HFrEF (38.3%) and HFpEF (44%). The group was small but the “results suggested that patients with HFmrEF could have a better prognosis, because they can represent a distinct and more favorable HF phenotype,” the authors wrote.
The statistical testing didn’t show much difference and the patient numbers were very small, noted Dr. Goldberg. “So they might be overreaching a little bit there.”
“To me, the take-home message is that just having the phenotype of heart failure, regardless of EF, is associated with bad outcomes and we need to be vigilant on two fronts,” he said. “We really need to be doing prevention in the folks with heart failure because if they get COVID their outcomes are not going to be as good. Second, as clinicians, if we see a patient presenting with COVID who has a history of heart failure we may want to be much more vigilant with that individual than we might otherwise be. So I think there’s something to be said for kind of risk-stratifying people in that way.”
Dr. Goldberg pointed out that the study had many “amazing strengths,” including a large, racially diverse population, direct chart review to identify HF patients, and capturing a patient’s specific HF phenotype.
Weaknesses are that it was a single-center study, so the biases of how these patients were treated are not easily controlled for, he said. “We also don’t know when the hospital system was very strained as they were making some decisions: Were the older patients who had advanced heart and lung disease ultimately less aggressively treated because they felt they wouldn’t survive?”
Dr. Lala has received personal fees from Zoll, outside the submitted work. Dr. Goldberg reported research funding with Respicardia and consulting fees from Abbott.
This article first appeared on Medscape.com.
People with a history of heart failure – no matter the type – face more complications and death than their peers without HF once hospitalized with COVID-19, a new observational study shows.
A history of HF was associated with a near doubling risk of in-hospital mortality and ICU care and more than a tripling risk of mechanical ventilation despite adjustment for 18 factors including race, obesity, diabetes, previous treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors, and severity of illness.
Adverse outcomes were high regardless of whether patients had HF with a preserved, mid-range, or reduced left ventricular ejection fraction (HFpEF/HFmrEF/HFrEF).
“That for me was the real zinger,” senior author Anuradha Lala, MD, said in an interview . “Because as clinicians, oftentimes, and wrongly so, we think this person has preserved ejection fraction, so they’re not needing my heart failure expertise as much as someone with heart failure with reduced ejection fraction.”
In the peak of the pandemic, that may have meant triaging patients with HFpEF to a regular floor, whereas those with HFrEF were seen by the specialist team.
“What this alerted me to is to take heart failure as a diagnosis very seriously, regardless of ejection fraction, and that is very much in line with all of the emerging data about heart failure with preserved ejection fraction,” said Dr. Lala, from the Icahn School of Medicine at Mount Sinai, New York.
“Now when I see patients in the clinic, I incorporate part of our visit to talking about what they are doing to prevent COVID, which I really wasn’t doing before. It was like ‘Oh yeah, what crazy times we’re dealing with’ and then addressing their heart failure as I normally would,” she said. “But now, interwoven into every visit is: Are you wearing a mask, what’s your social distancing policy, who are you living with at home, has anyone at home or who you’ve interacted with been sick? I’m asking those questions just as a knee-jerk reaction for these patients because I know the repercussions. We have to keep in mind these are observational studies, so I can’t prove causality but these are observations that are, nonetheless, quite robust.”
Although cardiovascular disease, including HF, is recognized as a risk factor for worse outcomes in COVID-19 patients, data are sparse on the clinical course and prognosis of patients with preexisting HF.
“I would have expected that there would have been a gradation of risk from the people with very low ejection fractions up into the normal range, but here it didn’t seem to matter at all. So that’s an important point that bad outcomes were independent of ejection fraction,” commented Lee Goldberg, MD, professor of medicine and chief of advanced heart failure and cardiac transplant at the University of Pennsylvania, Philadelphia.
The study also validated that there is no association between use of RAAS inhibitors and bad outcomes in patients with COVID-19, he said.
Although this has been demonstrated in several studies, concerns were raised early in the pandemic that ACE inhibitors and angiotensin receptor blockers could facilitate infection with SARS-CoV-2 and increase the risk of severe or lethal COVID-19.
“For most clinicians that question has been put to bed, but we’re still getting patients that will ask during office visits ‘Is it safe for me to stay on?’ They still have that doubt [about] ‘Are we doing the right thing?’ ” Dr. Goldberg said.
“We can reassure them now. A lot of us are able to say there’s nothing to that, we’re very clear about this, stay on the meds. If anything, there’s data that suggest actually it may be better to be on an ACE inhibitor; that the hospitalizations were shorter and the outcomes were a little bit better.”
For the current study, published online Oct. 28 in the Journal of the American College of Cardiology, the investigators analyzed 6,439 patients admitted for COVID-19 at one of five Mount Sinai Health System hospitals in New York between Feb. 27 and June 26. Their mean age was 65.3 years, 45% were women, and one-third were treated with RAAS inhibitors before admission.
Using ICD-9/10 codes and individual chart review, HF was identified in 422 patients (6.6%), of which 250 patients had HFpEF (≥50%), 44 had HFmrEF (41%-49%), and 128 had HFrEF (≤40%).
Patients with HFpEF were older, more frequently women with a higher body mass index and history of lung disease than patients with HFrEF, whereas those with HFmrEF fell in between.
The HFpEF group was also treated with hydroxychloroquine or macrolides and noninvasive ventilation more frequently than the other two groups, whereas antiplatelet and neurohormonal therapies were more common in the HFrEF group.
Patients with a history of HF had significantly longer hospital stays than those without HF (8 days vs. 6 days), increased need for intubation (22.8% vs. 11.9%) and ICU care (23.2% vs. 16.6%), and worse in-hospital mortality (40% vs. 24.9%).
After multivariable regression adjustment, HF persisted as an independent risk factor for ICU care (odds ratio, 1.71; 95% CI, 1.25-2.34), intubation and mechanical ventilation (OR, 3.64; 95% CI, 2.56-5.16), and in-hospital mortality (OR, 1.88; 95% CI, 1.27-2.78).
“I knew to expect higher rates of adverse outcomes but I didn’t expect it to be nearly a twofold increase,” Dr. Lala said. “I thought that was pretty powerful.”
No significant differences were seen across LVEF categories in length of stay, need for ICU care, intubation and mechanical ventilation, acute kidney injury, shock, thromboembolic events, arrhythmias, or 30-day readmission rates.
However, cardiogenic shock (7.8% vs. 2.3% vs. 2%) and HF-related causes for 30-day readmissions (47.1% vs. 0% vs. 8.6%) were significantly higher in patients with HFrEF than in those with HFmrEF or HFpEF.
Also, mortality was lower in those with HFmrEF (22.7%) than with HFrEF (38.3%) and HFpEF (44%). The group was small but the “results suggested that patients with HFmrEF could have a better prognosis, because they can represent a distinct and more favorable HF phenotype,” the authors wrote.
The statistical testing didn’t show much difference and the patient numbers were very small, noted Dr. Goldberg. “So they might be overreaching a little bit there.”
“To me, the take-home message is that just having the phenotype of heart failure, regardless of EF, is associated with bad outcomes and we need to be vigilant on two fronts,” he said. “We really need to be doing prevention in the folks with heart failure because if they get COVID their outcomes are not going to be as good. Second, as clinicians, if we see a patient presenting with COVID who has a history of heart failure we may want to be much more vigilant with that individual than we might otherwise be. So I think there’s something to be said for kind of risk-stratifying people in that way.”
Dr. Goldberg pointed out that the study had many “amazing strengths,” including a large, racially diverse population, direct chart review to identify HF patients, and capturing a patient’s specific HF phenotype.
Weaknesses are that it was a single-center study, so the biases of how these patients were treated are not easily controlled for, he said. “We also don’t know when the hospital system was very strained as they were making some decisions: Were the older patients who had advanced heart and lung disease ultimately less aggressively treated because they felt they wouldn’t survive?”
Dr. Lala has received personal fees from Zoll, outside the submitted work. Dr. Goldberg reported research funding with Respicardia and consulting fees from Abbott.
This article first appeared on Medscape.com.
People with a history of heart failure – no matter the type – face more complications and death than their peers without HF once hospitalized with COVID-19, a new observational study shows.
A history of HF was associated with a near doubling risk of in-hospital mortality and ICU care and more than a tripling risk of mechanical ventilation despite adjustment for 18 factors including race, obesity, diabetes, previous treatment with renin-angiotensin-aldosterone system (RAAS) inhibitors, and severity of illness.
Adverse outcomes were high regardless of whether patients had HF with a preserved, mid-range, or reduced left ventricular ejection fraction (HFpEF/HFmrEF/HFrEF).
“That for me was the real zinger,” senior author Anuradha Lala, MD, said in an interview . “Because as clinicians, oftentimes, and wrongly so, we think this person has preserved ejection fraction, so they’re not needing my heart failure expertise as much as someone with heart failure with reduced ejection fraction.”
In the peak of the pandemic, that may have meant triaging patients with HFpEF to a regular floor, whereas those with HFrEF were seen by the specialist team.
“What this alerted me to is to take heart failure as a diagnosis very seriously, regardless of ejection fraction, and that is very much in line with all of the emerging data about heart failure with preserved ejection fraction,” said Dr. Lala, from the Icahn School of Medicine at Mount Sinai, New York.
“Now when I see patients in the clinic, I incorporate part of our visit to talking about what they are doing to prevent COVID, which I really wasn’t doing before. It was like ‘Oh yeah, what crazy times we’re dealing with’ and then addressing their heart failure as I normally would,” she said. “But now, interwoven into every visit is: Are you wearing a mask, what’s your social distancing policy, who are you living with at home, has anyone at home or who you’ve interacted with been sick? I’m asking those questions just as a knee-jerk reaction for these patients because I know the repercussions. We have to keep in mind these are observational studies, so I can’t prove causality but these are observations that are, nonetheless, quite robust.”
Although cardiovascular disease, including HF, is recognized as a risk factor for worse outcomes in COVID-19 patients, data are sparse on the clinical course and prognosis of patients with preexisting HF.
“I would have expected that there would have been a gradation of risk from the people with very low ejection fractions up into the normal range, but here it didn’t seem to matter at all. So that’s an important point that bad outcomes were independent of ejection fraction,” commented Lee Goldberg, MD, professor of medicine and chief of advanced heart failure and cardiac transplant at the University of Pennsylvania, Philadelphia.
The study also validated that there is no association between use of RAAS inhibitors and bad outcomes in patients with COVID-19, he said.
Although this has been demonstrated in several studies, concerns were raised early in the pandemic that ACE inhibitors and angiotensin receptor blockers could facilitate infection with SARS-CoV-2 and increase the risk of severe or lethal COVID-19.
“For most clinicians that question has been put to bed, but we’re still getting patients that will ask during office visits ‘Is it safe for me to stay on?’ They still have that doubt [about] ‘Are we doing the right thing?’ ” Dr. Goldberg said.
“We can reassure them now. A lot of us are able to say there’s nothing to that, we’re very clear about this, stay on the meds. If anything, there’s data that suggest actually it may be better to be on an ACE inhibitor; that the hospitalizations were shorter and the outcomes were a little bit better.”
For the current study, published online Oct. 28 in the Journal of the American College of Cardiology, the investigators analyzed 6,439 patients admitted for COVID-19 at one of five Mount Sinai Health System hospitals in New York between Feb. 27 and June 26. Their mean age was 65.3 years, 45% were women, and one-third were treated with RAAS inhibitors before admission.
Using ICD-9/10 codes and individual chart review, HF was identified in 422 patients (6.6%), of which 250 patients had HFpEF (≥50%), 44 had HFmrEF (41%-49%), and 128 had HFrEF (≤40%).
Patients with HFpEF were older, more frequently women with a higher body mass index and history of lung disease than patients with HFrEF, whereas those with HFmrEF fell in between.
The HFpEF group was also treated with hydroxychloroquine or macrolides and noninvasive ventilation more frequently than the other two groups, whereas antiplatelet and neurohormonal therapies were more common in the HFrEF group.
Patients with a history of HF had significantly longer hospital stays than those without HF (8 days vs. 6 days), increased need for intubation (22.8% vs. 11.9%) and ICU care (23.2% vs. 16.6%), and worse in-hospital mortality (40% vs. 24.9%).
After multivariable regression adjustment, HF persisted as an independent risk factor for ICU care (odds ratio, 1.71; 95% CI, 1.25-2.34), intubation and mechanical ventilation (OR, 3.64; 95% CI, 2.56-5.16), and in-hospital mortality (OR, 1.88; 95% CI, 1.27-2.78).
“I knew to expect higher rates of adverse outcomes but I didn’t expect it to be nearly a twofold increase,” Dr. Lala said. “I thought that was pretty powerful.”
No significant differences were seen across LVEF categories in length of stay, need for ICU care, intubation and mechanical ventilation, acute kidney injury, shock, thromboembolic events, arrhythmias, or 30-day readmission rates.
However, cardiogenic shock (7.8% vs. 2.3% vs. 2%) and HF-related causes for 30-day readmissions (47.1% vs. 0% vs. 8.6%) were significantly higher in patients with HFrEF than in those with HFmrEF or HFpEF.
Also, mortality was lower in those with HFmrEF (22.7%) than with HFrEF (38.3%) and HFpEF (44%). The group was small but the “results suggested that patients with HFmrEF could have a better prognosis, because they can represent a distinct and more favorable HF phenotype,” the authors wrote.
The statistical testing didn’t show much difference and the patient numbers were very small, noted Dr. Goldberg. “So they might be overreaching a little bit there.”
“To me, the take-home message is that just having the phenotype of heart failure, regardless of EF, is associated with bad outcomes and we need to be vigilant on two fronts,” he said. “We really need to be doing prevention in the folks with heart failure because if they get COVID their outcomes are not going to be as good. Second, as clinicians, if we see a patient presenting with COVID who has a history of heart failure we may want to be much more vigilant with that individual than we might otherwise be. So I think there’s something to be said for kind of risk-stratifying people in that way.”
Dr. Goldberg pointed out that the study had many “amazing strengths,” including a large, racially diverse population, direct chart review to identify HF patients, and capturing a patient’s specific HF phenotype.
Weaknesses are that it was a single-center study, so the biases of how these patients were treated are not easily controlled for, he said. “We also don’t know when the hospital system was very strained as they were making some decisions: Were the older patients who had advanced heart and lung disease ultimately less aggressively treated because they felt they wouldn’t survive?”
Dr. Lala has received personal fees from Zoll, outside the submitted work. Dr. Goldberg reported research funding with Respicardia and consulting fees from Abbott.
This article first appeared on Medscape.com.