MDedge Infectious Disease

Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.

“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.

“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
 

Burnout is not selective

There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.

He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.

Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.

Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. In the fall of 2020, 69% reported depression and “a very alarming figure” of 13% reported having thoughts of suicide, Dr. Howard said.

Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data. 

“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.

Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.

“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
 

Primary prevention approach

To tackle the burnout crisis, NIOSH plans to:

• Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
• Assimilate the evidence and create a repository of best practices, resources, and interventions.
• Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
• Identify and adapt tools for the health care workplace that emphasize stress reduction.

NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.

This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.

Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.

A version of this article first appeared on Medscape.com.

Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.

“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.

“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
 

Burnout is not selective

There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.

He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.

Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.

Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. In the fall of 2020, 69% reported depression and “a very alarming figure” of 13% reported having thoughts of suicide, Dr. Howard said.

Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data. 

“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.

Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.

“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
 

Primary prevention approach

To tackle the burnout crisis, NIOSH plans to:

• Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
• Assimilate the evidence and create a repository of best practices, resources, and interventions.
• Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
• Identify and adapt tools for the health care workplace that emphasize stress reduction.

NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.

This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.

Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.

A version of this article first appeared on Medscape.com.

Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.

“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.

“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
 

Burnout is not selective

There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.

He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.

Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.

Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. In the fall of 2020, 69% reported depression and “a very alarming figure” of 13% reported having thoughts of suicide, Dr. Howard said.

Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data. 

“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.

Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.

“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
 

Primary prevention approach

To tackle the burnout crisis, NIOSH plans to:

• Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
• Assimilate the evidence and create a repository of best practices, resources, and interventions.
• Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
• Identify and adapt tools for the health care workplace that emphasize stress reduction.

NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.

This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.

Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.

A version of this article first appeared on Medscape.com.

Everyone over the age of 18 should be allowed to receive a booster of their COVID-19 vaccines, according to a panel of experts that advises CDC on its vaccine recommendations.

The Advisory Committee on Immunization Practices, or ACIP, recommended that all adults be eligible for a third dose of a Pfizer or Moderna mRNA vaccine, at least 6 months after their second dose.

They also strengthened a recommendation that everyone over the age of 50 should get a third dose, whether or not they have an underlying health condition that may increase their risk from a COVID-19 infection.

The committee voted 11 to 0 in favor of both policies.

CDC Director Rochelle Walensky, MD, must now sign off on both policies, which she is expected to do.

More than 70 million adults are now eligible for booster shots in the United States, but only about 31 million people have received one.  About half of those who have been boosted are over the age of 65.

In a recent survey, the Kaiser Family Foundation found that about 4 in 10 younger adults said they were unsure if they qualified for a booster.

Under the current policy, boosters are recommended for everyone age 65 and older.  But people who are younger than age 65 are eligible for boosters if they have an underlying health condition or live or work in a high-risk situation—something individuals have to determine on their own.  Experts said that shading of the policy had created confusion that was holding people back.

Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials, noted that public health officials have been swamped with calls from people who are trying to figure out if they are eligible to get a booster dose.

He said that in a call the evening of Nov. 18 with state health departments, “There was not a single state that voiced opposition to this move,” he told the ACIP.

Dr. Shah said that the current guidelines were well intentioned, but “in pursuit of precision, they create confusion.”

“Our concern is that eligible individuals are not receiving boosters right now as a result of this confusion,” he said.

The committee based its decision on the results of a new study of boosters in Pfizer vaccine recipients, as well as reassuring safety information that’s being collected through the CDC and FDA’s monitoring systems.

Pfizer presented the early results from a study of 10,000 people who had all received two doses of its vaccine.   Half of the study participants received a third shot, or booster. The other half got a placebo.

The study is ongoing, but so far, six of the people in the booster group have gotten a COVID-19 infection with symptoms compared to 123 people who got COVID-19 in the placebo group, making boosters 95% effective at keeping people from getting sick.  Most people in the study had gotten their original doses about 10 months earlier. They’ve been followed for about 10 weeks since their booster.  Importantly, there were no study participants hospitalized for COVID-19 infections in either the placebo or booster group, indicating that the first two doses were still very effective at preventing severe outcomes from infection.

The majority of side effects after a third Pfizer dose were mild and temporary.  Side effects like sore arms, swelling, fever, headache, and fatigue were more common in the booster group — affecting about 1 in 4 people who got a third shot.  Vaccination side effects were less common after boosters than have been seen after the second dose of the vaccine.

Some cases of myocarditis and pericarditis have been reported after people received vaccine boosters, but the risk for this heart inflammation appears to be extremely low, about two cases for every million doses given.  There were 54 cases of myocarditis reported so far to the Vaccine Adverse Event Reporting System, or VAERS.  So far, only 12 have met the case definition and are considered related to vaccination.  Most of the reported cases are still being studied.

Everyone over the age of 18 should be allowed to receive a booster of their COVID-19 vaccines, according to a panel of experts that advises CDC on its vaccine recommendations.

The Advisory Committee on Immunization Practices, or ACIP, recommended that all adults be eligible for a third dose of a Pfizer or Moderna mRNA vaccine, at least 6 months after their second dose.

They also strengthened a recommendation that everyone over the age of 50 should get a third dose, whether or not they have an underlying health condition that may increase their risk from a COVID-19 infection.

The committee voted 11 to 0 in favor of both policies.

CDC Director Rochelle Walensky, MD, must now sign off on both policies, which she is expected to do.

More than 70 million adults are now eligible for booster shots in the United States, but only about 31 million people have received one.  About half of those who have been boosted are over the age of 65.

In a recent survey, the Kaiser Family Foundation found that about 4 in 10 younger adults said they were unsure if they qualified for a booster.

Under the current policy, boosters are recommended for everyone age 65 and older.  But people who are younger than age 65 are eligible for boosters if they have an underlying health condition or live or work in a high-risk situation—something individuals have to determine on their own.  Experts said that shading of the policy had created confusion that was holding people back.

Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials, noted that public health officials have been swamped with calls from people who are trying to figure out if they are eligible to get a booster dose.

He said that in a call the evening of Nov. 18 with state health departments, “There was not a single state that voiced opposition to this move,” he told the ACIP.

Dr. Shah said that the current guidelines were well intentioned, but “in pursuit of precision, they create confusion.”

“Our concern is that eligible individuals are not receiving boosters right now as a result of this confusion,” he said.

The committee based its decision on the results of a new study of boosters in Pfizer vaccine recipients, as well as reassuring safety information that’s being collected through the CDC and FDA’s monitoring systems.

Pfizer presented the early results from a study of 10,000 people who had all received two doses of its vaccine.   Half of the study participants received a third shot, or booster. The other half got a placebo.

The study is ongoing, but so far, six of the people in the booster group have gotten a COVID-19 infection with symptoms compared to 123 people who got COVID-19 in the placebo group, making boosters 95% effective at keeping people from getting sick.  Most people in the study had gotten their original doses about 10 months earlier. They’ve been followed for about 10 weeks since their booster.  Importantly, there were no study participants hospitalized for COVID-19 infections in either the placebo or booster group, indicating that the first two doses were still very effective at preventing severe outcomes from infection.

The majority of side effects after a third Pfizer dose were mild and temporary.  Side effects like sore arms, swelling, fever, headache, and fatigue were more common in the booster group — affecting about 1 in 4 people who got a third shot.  Vaccination side effects were less common after boosters than have been seen after the second dose of the vaccine.

Some cases of myocarditis and pericarditis have been reported after people received vaccine boosters, but the risk for this heart inflammation appears to be extremely low, about two cases for every million doses given.  There were 54 cases of myocarditis reported so far to the Vaccine Adverse Event Reporting System, or VAERS.  So far, only 12 have met the case definition and are considered related to vaccination.  Most of the reported cases are still being studied.

Everyone over the age of 18 should be allowed to receive a booster of their COVID-19 vaccines, according to a panel of experts that advises CDC on its vaccine recommendations.

The Advisory Committee on Immunization Practices, or ACIP, recommended that all adults be eligible for a third dose of a Pfizer or Moderna mRNA vaccine, at least 6 months after their second dose.

They also strengthened a recommendation that everyone over the age of 50 should get a third dose, whether or not they have an underlying health condition that may increase their risk from a COVID-19 infection.

The committee voted 11 to 0 in favor of both policies.

CDC Director Rochelle Walensky, MD, must now sign off on both policies, which she is expected to do.

More than 70 million adults are now eligible for booster shots in the United States, but only about 31 million people have received one.  About half of those who have been boosted are over the age of 65.

In a recent survey, the Kaiser Family Foundation found that about 4 in 10 younger adults said they were unsure if they qualified for a booster.

Under the current policy, boosters are recommended for everyone age 65 and older.  But people who are younger than age 65 are eligible for boosters if they have an underlying health condition or live or work in a high-risk situation—something individuals have to determine on their own.  Experts said that shading of the policy had created confusion that was holding people back.

Nirav Shah, MD, JD, president of the Association of State and Territorial Health Officials, noted that public health officials have been swamped with calls from people who are trying to figure out if they are eligible to get a booster dose.

He said that in a call the evening of Nov. 18 with state health departments, “There was not a single state that voiced opposition to this move,” he told the ACIP.

Dr. Shah said that the current guidelines were well intentioned, but “in pursuit of precision, they create confusion.”

“Our concern is that eligible individuals are not receiving boosters right now as a result of this confusion,” he said.

The committee based its decision on the results of a new study of boosters in Pfizer vaccine recipients, as well as reassuring safety information that’s being collected through the CDC and FDA’s monitoring systems.

Pfizer presented the early results from a study of 10,000 people who had all received two doses of its vaccine.   Half of the study participants received a third shot, or booster. The other half got a placebo.

The study is ongoing, but so far, six of the people in the booster group have gotten a COVID-19 infection with symptoms compared to 123 people who got COVID-19 in the placebo group, making boosters 95% effective at keeping people from getting sick.  Most people in the study had gotten their original doses about 10 months earlier. They’ve been followed for about 10 weeks since their booster.  Importantly, there were no study participants hospitalized for COVID-19 infections in either the placebo or booster group, indicating that the first two doses were still very effective at preventing severe outcomes from infection.

The majority of side effects after a third Pfizer dose were mild and temporary.  Side effects like sore arms, swelling, fever, headache, and fatigue were more common in the booster group — affecting about 1 in 4 people who got a third shot.  Vaccination side effects were less common after boosters than have been seen after the second dose of the vaccine.

Some cases of myocarditis and pericarditis have been reported after people received vaccine boosters, but the risk for this heart inflammation appears to be extremely low, about two cases for every million doses given.  There were 54 cases of myocarditis reported so far to the Vaccine Adverse Event Reporting System, or VAERS.  So far, only 12 have met the case definition and are considered related to vaccination.  Most of the reported cases are still being studied.

Joel Bervell recalls leaving his hometown of Seattle for the East Coast after being accepted into Yale University.

Still getting accustomed to the big move, Mr. Bervell, who had breezed through high school with straight As, went to see his chemistry professor for advice after getting a low grade on a test.

“He took one look at me and said, ‘Oh, if you’re on the football team, you don’t need to worry about it. So many people from the football team come into the class and end up dropping out, so if you need to drop this class, you can,’ ” Mr. Bervell says.

Mr. Bervell, who is Black, was not on the football team, nor did he receive a sports scholarship of any kind.

“For that professor to make an assumption of me, which to me felt like it was based on my race, made me less likely to want to go into a science field, where I felt like I was being judged before I even had a chance to prove myself,” Mr. Bervell says.

Discrimination can lead to particularly harmful outcomes for young adults entering college or starting off their careers, according to a new University of California, Los Angeles, study.

Researchers studied health data on 1,834 Americans ages 18-28 over a 10-year span. Findings show that the more instances of discrimination they experienced – including ageism, sexism, and racism – the more likely they were to face mental and behavioral struggles, like mental illness, drug use, severe psychological distress, and poor overall health.

Mr. Bervell, now 26, says he feels lucky that growing up, he was taught healthy ways to process his feelings and emotions.

“Instead of taking that and internalizing it, I said, ‘how can I use this to prove him wrong?’” he says. “Does that mean I need to work harder or does that mean I need to find a different mentor? Surround myself with different people?”

Mr. Bervell is currently a 3rd-year medical student at Washington State University.

When he’s not at the hospital seeing patients, you can find him educating his nearly 340,000 TikTok followers on topics like racial bias in medicine.
 

Acknowledge the impact

Most Black people don’t tie psychological distress to acts of racism, according to Rheeda Walker, PhD, psychology professor at the University of Houston and author of “The Unapologetic Guide to Black Mental Health” (Oakland, Calif.: New Harbinger Publications, 2020).

Many Black people even normalize it.

“Individuals deal with it [racism] as just another thing, like paying bills, going to work, and studying for class and not as the overwhelming psychological burden that it is,” says Dr. Walker.

And despite what some may say, racial discrimination is not merely “a thing of the past,” Dr. Walker says.

“Instead, discrimination has shifted form from more overt forms of discrimination to less obvious microaggression,” she says.

It’s also critical that young adults are taught how to deal with racism to avoid the risk of “internalizing that they deserve to be mistreated, and/or that they have to work twice as hard to overcome racism,” says Dr. Walker.

“Both scenarios can escalate hopelessness and worry, psychological features of depression and anxiety, respectively,” Dr. Walker says.
 

Embrace your emotions

Known around the office as “a big teddy bear,” Frederick Herman, a mortgage loan originator based in Charlotte, Va., was coaching a newer employee on how to make sales calls, a common practice in his line of work.

He says a day or 2 days later, his manager let him know that he had made an employee “very uncomfortable” by intimidating them while they were on the phone. Mr. Herman, 29, was told to watch his “aggressive” behavior.

“I’m a bigger Black man. I’m like 6’2, 300 lbs., somewhat muscular. So, if me talking or trying to coach her came off as intimidating, then there’s nothing that I could do or say differently than I was already doing to make her not feel intimidated,” Mr. Herman says.

“If a big teddy bear is now intimidating to you, that just tells me everything I need to know.”

This wasn’t the first time Mr. Herman had been reprimanded for being “too aggressive” or “showing off” when trying to help colleagues at work.

“I’ve had other experiences at work where I may not share my ideas, or I may get super anxious,” says Mr. Herman, a Black man of Haitian descent.

It’s important to allow yourself to feel your emotions after facing acts of discrimination, says Ebony Butler, PhD, a licensed psychologist and creator of My Therapy Cards, a card deck tailored for men, women, and teens of color, with self-care and reflection prompts.

This is a practice called “self-validation” and can reduce the tendency to blame oneself for the mistreatment, says Dr. Butler.

Mr. Herman, 29, says that he recently signed up for therapy to work through his struggles with anxiety.

Relaxation techniques, like grounding and mindfulness, can also be helpful, says Dr. Butler.

“Some example ways to practice grounding are immersing oneself in nature, walking bare feet on the ground, lying on the floor, practicing slow, deep breathing, or engaging the senses,” she says.

“When we are grounded and present, we can better manage our responses and plan our action steps.”
 

Utilize unique

If you find yourself in a racially charged school or workplace setting, don’t be intimidated, says Wendy Osefo, PhD, education professor at Johns Hopkins University, Baltimore, political commentator, and television personality.

Dr. Osefo made history in 2016 as the first Black woman to earn a PhD in public affairs/community development from Rutgers University.

“Your attitude should be that, no matter how different you might be, you belong, and you earned the right to occupy this space. You’re not less qualified than others who surround you,” she says.

Dr. Ofeso is also CEO of The 1954 Equity Project, an organization that gives minority students tools to succeed in higher education – like mentorships, peer support groups, and other resources and services – all while remaining their authentic selves.

No matter how uncomfortable it might be, staying true to who you are vs. conforming to the masses pays off, says Dr. Osefo.

“Being different is unique and allows you to bring a new and fresh perspective into an environment,” she says.

“Leaning into this uniqueness builds a level of confidence that will aid in your ability to be successful.”

A version of this article first appeared on WebMD.com.

Joel Bervell recalls leaving his hometown of Seattle for the East Coast after being accepted into Yale University.

Still getting accustomed to the big move, Mr. Bervell, who had breezed through high school with straight As, went to see his chemistry professor for advice after getting a low grade on a test.

“He took one look at me and said, ‘Oh, if you’re on the football team, you don’t need to worry about it. So many people from the football team come into the class and end up dropping out, so if you need to drop this class, you can,’ ” Mr. Bervell says.

Mr. Bervell, who is Black, was not on the football team, nor did he receive a sports scholarship of any kind.

“For that professor to make an assumption of me, which to me felt like it was based on my race, made me less likely to want to go into a science field, where I felt like I was being judged before I even had a chance to prove myself,” Mr. Bervell says.

Discrimination can lead to particularly harmful outcomes for young adults entering college or starting off their careers, according to a new University of California, Los Angeles, study.

Researchers studied health data on 1,834 Americans ages 18-28 over a 10-year span. Findings show that the more instances of discrimination they experienced – including ageism, sexism, and racism – the more likely they were to face mental and behavioral struggles, like mental illness, drug use, severe psychological distress, and poor overall health.

Mr. Bervell, now 26, says he feels lucky that growing up, he was taught healthy ways to process his feelings and emotions.

“Instead of taking that and internalizing it, I said, ‘how can I use this to prove him wrong?’” he says. “Does that mean I need to work harder or does that mean I need to find a different mentor? Surround myself with different people?”

Mr. Bervell is currently a 3rd-year medical student at Washington State University.

When he’s not at the hospital seeing patients, you can find him educating his nearly 340,000 TikTok followers on topics like racial bias in medicine.
 

Acknowledge the impact

Most Black people don’t tie psychological distress to acts of racism, according to Rheeda Walker, PhD, psychology professor at the University of Houston and author of “The Unapologetic Guide to Black Mental Health” (Oakland, Calif.: New Harbinger Publications, 2020).

Many Black people even normalize it.

“Individuals deal with it [racism] as just another thing, like paying bills, going to work, and studying for class and not as the overwhelming psychological burden that it is,” says Dr. Walker.

And despite what some may say, racial discrimination is not merely “a thing of the past,” Dr. Walker says.

“Instead, discrimination has shifted form from more overt forms of discrimination to less obvious microaggression,” she says.

It’s also critical that young adults are taught how to deal with racism to avoid the risk of “internalizing that they deserve to be mistreated, and/or that they have to work twice as hard to overcome racism,” says Dr. Walker.

“Both scenarios can escalate hopelessness and worry, psychological features of depression and anxiety, respectively,” Dr. Walker says.
 

Embrace your emotions

Known around the office as “a big teddy bear,” Frederick Herman, a mortgage loan originator based in Charlotte, Va., was coaching a newer employee on how to make sales calls, a common practice in his line of work.

He says a day or 2 days later, his manager let him know that he had made an employee “very uncomfortable” by intimidating them while they were on the phone. Mr. Herman, 29, was told to watch his “aggressive” behavior.

“I’m a bigger Black man. I’m like 6’2, 300 lbs., somewhat muscular. So, if me talking or trying to coach her came off as intimidating, then there’s nothing that I could do or say differently than I was already doing to make her not feel intimidated,” Mr. Herman says.

“If a big teddy bear is now intimidating to you, that just tells me everything I need to know.”

This wasn’t the first time Mr. Herman had been reprimanded for being “too aggressive” or “showing off” when trying to help colleagues at work.

“I’ve had other experiences at work where I may not share my ideas, or I may get super anxious,” says Mr. Herman, a Black man of Haitian descent.

It’s important to allow yourself to feel your emotions after facing acts of discrimination, says Ebony Butler, PhD, a licensed psychologist and creator of My Therapy Cards, a card deck tailored for men, women, and teens of color, with self-care and reflection prompts.

This is a practice called “self-validation” and can reduce the tendency to blame oneself for the mistreatment, says Dr. Butler.

Mr. Herman, 29, says that he recently signed up for therapy to work through his struggles with anxiety.

Relaxation techniques, like grounding and mindfulness, can also be helpful, says Dr. Butler.

“Some example ways to practice grounding are immersing oneself in nature, walking bare feet on the ground, lying on the floor, practicing slow, deep breathing, or engaging the senses,” she says.

“When we are grounded and present, we can better manage our responses and plan our action steps.”
 

Utilize unique

If you find yourself in a racially charged school or workplace setting, don’t be intimidated, says Wendy Osefo, PhD, education professor at Johns Hopkins University, Baltimore, political commentator, and television personality.

Dr. Osefo made history in 2016 as the first Black woman to earn a PhD in public affairs/community development from Rutgers University.

“Your attitude should be that, no matter how different you might be, you belong, and you earned the right to occupy this space. You’re not less qualified than others who surround you,” she says.

Dr. Ofeso is also CEO of The 1954 Equity Project, an organization that gives minority students tools to succeed in higher education – like mentorships, peer support groups, and other resources and services – all while remaining their authentic selves.

No matter how uncomfortable it might be, staying true to who you are vs. conforming to the masses pays off, says Dr. Osefo.

“Being different is unique and allows you to bring a new and fresh perspective into an environment,” she says.

“Leaning into this uniqueness builds a level of confidence that will aid in your ability to be successful.”

A version of this article first appeared on WebMD.com.

Joel Bervell recalls leaving his hometown of Seattle for the East Coast after being accepted into Yale University.

Still getting accustomed to the big move, Mr. Bervell, who had breezed through high school with straight As, went to see his chemistry professor for advice after getting a low grade on a test.

“He took one look at me and said, ‘Oh, if you’re on the football team, you don’t need to worry about it. So many people from the football team come into the class and end up dropping out, so if you need to drop this class, you can,’ ” Mr. Bervell says.

Mr. Bervell, who is Black, was not on the football team, nor did he receive a sports scholarship of any kind.

“For that professor to make an assumption of me, which to me felt like it was based on my race, made me less likely to want to go into a science field, where I felt like I was being judged before I even had a chance to prove myself,” Mr. Bervell says.

Discrimination can lead to particularly harmful outcomes for young adults entering college or starting off their careers, according to a new University of California, Los Angeles, study.

Researchers studied health data on 1,834 Americans ages 18-28 over a 10-year span. Findings show that the more instances of discrimination they experienced – including ageism, sexism, and racism – the more likely they were to face mental and behavioral struggles, like mental illness, drug use, severe psychological distress, and poor overall health.

Mr. Bervell, now 26, says he feels lucky that growing up, he was taught healthy ways to process his feelings and emotions.

“Instead of taking that and internalizing it, I said, ‘how can I use this to prove him wrong?’” he says. “Does that mean I need to work harder or does that mean I need to find a different mentor? Surround myself with different people?”

Mr. Bervell is currently a 3rd-year medical student at Washington State University.

When he’s not at the hospital seeing patients, you can find him educating his nearly 340,000 TikTok followers on topics like racial bias in medicine.
 

Acknowledge the impact

Most Black people don’t tie psychological distress to acts of racism, according to Rheeda Walker, PhD, psychology professor at the University of Houston and author of “The Unapologetic Guide to Black Mental Health” (Oakland, Calif.: New Harbinger Publications, 2020).

Many Black people even normalize it.

“Individuals deal with it [racism] as just another thing, like paying bills, going to work, and studying for class and not as the overwhelming psychological burden that it is,” says Dr. Walker.

And despite what some may say, racial discrimination is not merely “a thing of the past,” Dr. Walker says.

“Instead, discrimination has shifted form from more overt forms of discrimination to less obvious microaggression,” she says.

It’s also critical that young adults are taught how to deal with racism to avoid the risk of “internalizing that they deserve to be mistreated, and/or that they have to work twice as hard to overcome racism,” says Dr. Walker.

“Both scenarios can escalate hopelessness and worry, psychological features of depression and anxiety, respectively,” Dr. Walker says.
 

Embrace your emotions

Known around the office as “a big teddy bear,” Frederick Herman, a mortgage loan originator based in Charlotte, Va., was coaching a newer employee on how to make sales calls, a common practice in his line of work.

He says a day or 2 days later, his manager let him know that he had made an employee “very uncomfortable” by intimidating them while they were on the phone. Mr. Herman, 29, was told to watch his “aggressive” behavior.

“I’m a bigger Black man. I’m like 6’2, 300 lbs., somewhat muscular. So, if me talking or trying to coach her came off as intimidating, then there’s nothing that I could do or say differently than I was already doing to make her not feel intimidated,” Mr. Herman says.

“If a big teddy bear is now intimidating to you, that just tells me everything I need to know.”

This wasn’t the first time Mr. Herman had been reprimanded for being “too aggressive” or “showing off” when trying to help colleagues at work.

“I’ve had other experiences at work where I may not share my ideas, or I may get super anxious,” says Mr. Herman, a Black man of Haitian descent.

It’s important to allow yourself to feel your emotions after facing acts of discrimination, says Ebony Butler, PhD, a licensed psychologist and creator of My Therapy Cards, a card deck tailored for men, women, and teens of color, with self-care and reflection prompts.

This is a practice called “self-validation” and can reduce the tendency to blame oneself for the mistreatment, says Dr. Butler.

Mr. Herman, 29, says that he recently signed up for therapy to work through his struggles with anxiety.

Relaxation techniques, like grounding and mindfulness, can also be helpful, says Dr. Butler.

“Some example ways to practice grounding are immersing oneself in nature, walking bare feet on the ground, lying on the floor, practicing slow, deep breathing, or engaging the senses,” she says.

“When we are grounded and present, we can better manage our responses and plan our action steps.”
 

Utilize unique

If you find yourself in a racially charged school or workplace setting, don’t be intimidated, says Wendy Osefo, PhD, education professor at Johns Hopkins University, Baltimore, political commentator, and television personality.

Dr. Osefo made history in 2016 as the first Black woman to earn a PhD in public affairs/community development from Rutgers University.

“Your attitude should be that, no matter how different you might be, you belong, and you earned the right to occupy this space. You’re not less qualified than others who surround you,” she says.

Dr. Ofeso is also CEO of The 1954 Equity Project, an organization that gives minority students tools to succeed in higher education – like mentorships, peer support groups, and other resources and services – all while remaining their authentic selves.

No matter how uncomfortable it might be, staying true to who you are vs. conforming to the masses pays off, says Dr. Osefo.

“Being different is unique and allows you to bring a new and fresh perspective into an environment,” she says.

“Leaning into this uniqueness builds a level of confidence that will aid in your ability to be successful.”

A version of this article first appeared on WebMD.com.

Medical practices will likely have to confront a doctor at some point who treats staff badly or is too impaired to practice safely. Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.

Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .

“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.

She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.

After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
 

Confront, correct, and/or counsel

The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.

Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.

She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.

She also recommends implementing these strategies to prevent and deal with disruptive physicians:

• Implement a code of conduct and share it during interviews;
• Have zero tolerance policies and procedures for documenting behavior;
• Get advice from a good employment attorney;
• Implement written performance improvement plans;
• Provide resources to change the behavior;
• Follow through with suspension and termination; and
• Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.

Getting impaired doctors help

Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.

Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.

She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”

Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.

Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:

• Include “fit for duty” examinations, especially after age 65.
• Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
• Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
• Establish a voting mechanism for terminating a physician.

Aging doctors who won’t retire

Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.

She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.

Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.

She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”

Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.

“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.

A version of this article first appeared on Medscape.com.

Medical practices will likely have to confront a doctor at some point who treats staff badly or is too impaired to practice safely. Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.

Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .

“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.

She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.

After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
 

Confront, correct, and/or counsel

The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.

Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.

She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.

She also recommends implementing these strategies to prevent and deal with disruptive physicians:

• Implement a code of conduct and share it during interviews;
• Have zero tolerance policies and procedures for documenting behavior;
• Get advice from a good employment attorney;
• Implement written performance improvement plans;
• Provide resources to change the behavior;
• Follow through with suspension and termination; and
• Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.

Getting impaired doctors help

Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.

Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.

She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”

Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.

Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:

• Include “fit for duty” examinations, especially after age 65.
• Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
• Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
• Establish a voting mechanism for terminating a physician.

Aging doctors who won’t retire

Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.

She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.

Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.

She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”

Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.

“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.

A version of this article first appeared on Medscape.com.

Medical practices will likely have to confront a doctor at some point who treats staff badly or is too impaired to practice safely. Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.

Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .

“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.

She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.

After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
 

Confront, correct, and/or counsel

The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.

Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.

She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.

She also recommends implementing these strategies to prevent and deal with disruptive physicians:

• Implement a code of conduct and share it during interviews;
• Have zero tolerance policies and procedures for documenting behavior;
• Get advice from a good employment attorney;
• Implement written performance improvement plans;
• Provide resources to change the behavior;
• Follow through with suspension and termination; and
• Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.

Getting impaired doctors help

Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.

Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.

She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”

Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.

Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:

• Include “fit for duty” examinations, especially after age 65.
• Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
• Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
• Establish a voting mechanism for terminating a physician.

Aging doctors who won’t retire

Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.

She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.

Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.

She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”

Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.

“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.

A version of this article first appeared on Medscape.com.

The Food and Drug Administration has given the green light to third, or booster doses of the Pfizer and Moderna vaccines for everyone over the age of 18, ahead of the busy winter holiday season.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.

Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.

FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.

A version of this article first appeared on WebMD.com.

The Food and Drug Administration has given the green light to third, or booster doses of the Pfizer and Moderna vaccines for everyone over the age of 18, ahead of the busy winter holiday season.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.

Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.

FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.

A version of this article first appeared on WebMD.com.

The Food and Drug Administration has given the green light to third, or booster doses of the Pfizer and Moderna vaccines for everyone over the age of 18, ahead of the busy winter holiday season.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.

Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.

FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.

A version of this article first appeared on WebMD.com.

When people wear face masks to reduce the spread of the coronavirus, the number of new COVID-19 infections drops by 53%, according to a new study published Nov. 18 in the British Medical Journal.

Social distancing and handwashing were also effective at lowering the number of cases, but wearing masks was the most effective tool against the coronavirus.

“Personal and social measures, including handwashing, mask wearing, and physical distancing are effective at reducing the incidence of COVID-19,” the study authors wrote.

The research team, which included public health and infectious disease specialists in Australia, China, and the U.K., evaluated 72 studies of COVID-19 precautions during the pandemic. They later looked at eight studies that focused on handwashing, mask wearing, and physical distancing.

Among six studies that looked at mask wearing, the researchers found a 53% reduction in COVID-19 cases. In the broader analysis with additional studies, wearing a mask reduced coronavirus transmission, cases, and deaths.

In one study across 200 countries, mandatory mask wearing resulted in nearly 46% fewer negative outcomes from COVID-19. In another study in the U.S., coronavirus transmission was reduced 29% in states where masks were mandatory.

But the research team couldn’t analyze the impact of the type of face mask used, the frequency of mask wearing, or the overall compliance with wearing face masks.

Among five studies that looked at physical distancing, the researchers found a 25% reduction in the rate of COVID-19. A study in the U.S. showed a 12% decrease in coronavirus transmission, while another study in Iran reported a reduction in COVID-19 mortality.

Handwashing interventions also suggested a substantial reduction of COVID-19 cases up to 53%, the researchers wrote. But in adjusted models, the results weren’t statistically significant due to the small number of studies included.

Other studies found significant decreases related to other public health measures, such as quarantines, broad lockdowns, border closures, school closures, business closures, and travel restrictions. Still, the research team couldn’t analyze the overall effectiveness of these measures due to the different ways the studies were conducted.

The study lines up with other research conducted so far during the pandemic, the research team wrote, which indicates that wearing masks and physical distancing can reduce transmission, cases, and deaths.

That said, more studies are needed, particularly now that vaccinations are available and contagious coronavirus variants have become prevalent.

“Further research is needed to assess the effectiveness of public health measures after adequate vaccination coverage has been achieved,” they wrote.

“It is likely that further control of the COVID-19 pandemic depends not only on high vaccination coverage and its effectiveness but also on ongoing adherence to effective and sustainable public health measures,” they concluded.

A version of this article first appeared on WebMD.com.

When people wear face masks to reduce the spread of the coronavirus, the number of new COVID-19 infections drops by 53%, according to a new study published Nov. 18 in the British Medical Journal.

Social distancing and handwashing were also effective at lowering the number of cases, but wearing masks was the most effective tool against the coronavirus.

“Personal and social measures, including handwashing, mask wearing, and physical distancing are effective at reducing the incidence of COVID-19,” the study authors wrote.

The research team, which included public health and infectious disease specialists in Australia, China, and the U.K., evaluated 72 studies of COVID-19 precautions during the pandemic. They later looked at eight studies that focused on handwashing, mask wearing, and physical distancing.

Among six studies that looked at mask wearing, the researchers found a 53% reduction in COVID-19 cases. In the broader analysis with additional studies, wearing a mask reduced coronavirus transmission, cases, and deaths.

In one study across 200 countries, mandatory mask wearing resulted in nearly 46% fewer negative outcomes from COVID-19. In another study in the U.S., coronavirus transmission was reduced 29% in states where masks were mandatory.

But the research team couldn’t analyze the impact of the type of face mask used, the frequency of mask wearing, or the overall compliance with wearing face masks.

Among five studies that looked at physical distancing, the researchers found a 25% reduction in the rate of COVID-19. A study in the U.S. showed a 12% decrease in coronavirus transmission, while another study in Iran reported a reduction in COVID-19 mortality.

Handwashing interventions also suggested a substantial reduction of COVID-19 cases up to 53%, the researchers wrote. But in adjusted models, the results weren’t statistically significant due to the small number of studies included.

Other studies found significant decreases related to other public health measures, such as quarantines, broad lockdowns, border closures, school closures, business closures, and travel restrictions. Still, the research team couldn’t analyze the overall effectiveness of these measures due to the different ways the studies were conducted.

The study lines up with other research conducted so far during the pandemic, the research team wrote, which indicates that wearing masks and physical distancing can reduce transmission, cases, and deaths.

That said, more studies are needed, particularly now that vaccinations are available and contagious coronavirus variants have become prevalent.

“Further research is needed to assess the effectiveness of public health measures after adequate vaccination coverage has been achieved,” they wrote.

“It is likely that further control of the COVID-19 pandemic depends not only on high vaccination coverage and its effectiveness but also on ongoing adherence to effective and sustainable public health measures,” they concluded.

A version of this article first appeared on WebMD.com.

When people wear face masks to reduce the spread of the coronavirus, the number of new COVID-19 infections drops by 53%, according to a new study published Nov. 18 in the British Medical Journal.

Social distancing and handwashing were also effective at lowering the number of cases, but wearing masks was the most effective tool against the coronavirus.

“Personal and social measures, including handwashing, mask wearing, and physical distancing are effective at reducing the incidence of COVID-19,” the study authors wrote.

The research team, which included public health and infectious disease specialists in Australia, China, and the U.K., evaluated 72 studies of COVID-19 precautions during the pandemic. They later looked at eight studies that focused on handwashing, mask wearing, and physical distancing.

Among six studies that looked at mask wearing, the researchers found a 53% reduction in COVID-19 cases. In the broader analysis with additional studies, wearing a mask reduced coronavirus transmission, cases, and deaths.

In one study across 200 countries, mandatory mask wearing resulted in nearly 46% fewer negative outcomes from COVID-19. In another study in the U.S., coronavirus transmission was reduced 29% in states where masks were mandatory.

But the research team couldn’t analyze the impact of the type of face mask used, the frequency of mask wearing, or the overall compliance with wearing face masks.

Among five studies that looked at physical distancing, the researchers found a 25% reduction in the rate of COVID-19. A study in the U.S. showed a 12% decrease in coronavirus transmission, while another study in Iran reported a reduction in COVID-19 mortality.

Handwashing interventions also suggested a substantial reduction of COVID-19 cases up to 53%, the researchers wrote. But in adjusted models, the results weren’t statistically significant due to the small number of studies included.

Other studies found significant decreases related to other public health measures, such as quarantines, broad lockdowns, border closures, school closures, business closures, and travel restrictions. Still, the research team couldn’t analyze the overall effectiveness of these measures due to the different ways the studies were conducted.

The study lines up with other research conducted so far during the pandemic, the research team wrote, which indicates that wearing masks and physical distancing can reduce transmission, cases, and deaths.

That said, more studies are needed, particularly now that vaccinations are available and contagious coronavirus variants have become prevalent.

“Further research is needed to assess the effectiveness of public health measures after adequate vaccination coverage has been achieved,” they wrote.

“It is likely that further control of the COVID-19 pandemic depends not only on high vaccination coverage and its effectiveness but also on ongoing adherence to effective and sustainable public health measures,” they concluded.

A version of this article first appeared on WebMD.com.

The SARS-CoV-2 pandemic has given added impetus for metagenomic testing using nanopore sequencing to progress from a research tool to routine clinical application. A study led by researchers from Guy’s and St. Thomas’ NHS Foundation Trust has shown the potential for clinical metagenomics to become a same-day test for identifying secondary infection in ventilated ICU patients. Getting results in hours rather than days would help to ensure rapid treatment with the correct antibiotic, minimize unnecessary prescriptions, and thus reduce the growing menace of antimicrobial resistance.

‘SARS-CoV-2 has put considerable strain on ICUs’

The researchers point out that the setting of an intensive care unit involves frequent staff-patient contact that imparts a risk of secondary or nosocomial infection. In addition, invasive ventilation may introduce organisms into the lungs and lead to ventilator-acquired pneumonia. This carries a high mortality and is responsible for up to 70% of antimicrobial prescribing, with current guidelines requiring empiric antibiotics pending culture results, which typically takes 2-4 days.

Many of these infection problems worsened during SARS-CoV-2. Expanded critical care capacity raised the risk of nosocomial infections, with attendant increased antimicrobial prescriptions and the threat of antimicrobial resistance. In addition, treatment of COVID-19 patients with steroid therapy potentially exacerbates bacterial or fungal infections.

The researchers, from the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, in collaboration with the Quadram Institute in Norwich, Oxford Nanopore Technologies, and Viapath, the U.K.’s largest independent pathology service provider, noted that the pandemic thus reinforced “a need for rapid comprehensive diagnostics to improve antimicrobial stewardship and help prevent emergence and transmission of multi-drug-resistant organisms.”

“As soon as the pandemic started, our scientists realized there would be a benefit to sequencing genomes of all bacteria and fungi causing infection in COVID-19 patients while on ICU,” said Professor Jonathan Edgeworth, who led the research team.

“Within a few weeks we showed it can diagnose secondary infection, target antibiotic treatment, and detect outbreaks much earlier than current technologies – all from a single sample.”
 

Proof-of-concept study

The team performed a proof-of-concept study of nanopore metagenomics sequencing – a type of DNA sequencing that allows direct rapid unbiased detection of all organisms present in a clinical sample – on 43 surplus respiratory samples from 34 intubated COVID-19 patients with suspected secondary bacterial or fungal pneumonia. Patients were drawn from seven ICUs at St. Thomas’ Hospital, London over a 9-week period between April 11 and June 15 2020, during the first wave of COVID-19.

Their median age was 52, 70% were male, 47% White, and 44% Black or minority ethnicities. Median length of stay was 32 days and mortality 24%. Samples sent for metagenomic analysis and culture included 10 bronchoalveolar lavages, 6 tracheal aspirates, and 27 non-direct bronchoalveolar lavages.

The study, published in Genome Medicine, showed that an 8-hour metagenomics workflow was 92% sensitive (95% CI, 75% to 99%) and 82% specific (95% CI, 57% to 96%) for bacterial identification, based on culture-positive and culture-negative samples, respectively.

The main Gram-negative bacteria identified were Klebsiella spp. (53%), Citrobacter spp. (15%), and E coli (9%). The main Gram-positive bacteria were S aureus (9%), C striatum (24%) and Enterococcus spp. (12%). In addition, C albicans, other Candida spp. and Aspergillus spp. were cultured from 38%, 15%, and 9% of patients, respectively.

In every case, the initial antibiotics prescribed according to prevailing guideline recommendations would have been modified by metagenomic sequencing demonstrating the presence or absence of β-lactam-resistant genes carried by Enterobacterales.

Next day results of sequencing also detected Aspergillus fumigatus in four samples, with results 100% concordant with quantitative PCR for both the four positive and 39 negative samples. It identified two multi-drug–resistant outbreaks, one involving K pneumoniae ST307 affecting four patients and one a C striatum outbreak involving 14 patients across three ICUs.

Thus, a single sample can provide enough genetic sequence data to compare pathogen genomes with a database and accurately identify patients carrying the same strain, enabling early detection of outbreaks. This is the first time this combined benefit of a single test has been demonstrated, the team say.

Gordon Sanghera, CEO of Oxford Nanopore commented that “rapidly characterizing co-infections for precision prescribing is a vital next step for both COVID-19 patients and respiratory disease in general.”

Dr. Andrew Page of the Quadram Institute said: “We have been working on metagenomics technology for the last 7 years. It is great to see it applied to patient care during the COVID-19 pandemic.”

He said in an interview: “The pandemic has accelerated the transition from using sequencing purely in research labs to using it in the clinic to rapidly provide clinicians with information they can use to improve outcomes for patients.”
 

Potential to inform antimicrobial prescribing and infection control

“Clinical metagenomic testing provides accurate pathogen detection and antibiotic resistance prediction in a same-day laboratory workflow, with assembled genomes available the next day for genomic surveillance,” the researchers say.

The technology “could fundamentally change the multi-disciplinary team approach to managing ICU infections.” It has the potential to improve initial targeted antimicrobial treatment and infection control decisions, as well as help rapidly detect unsuspected outbreaks of multi-drug–resistant pathogens.

Professor Edgeworth told this news organization that since the study, “secondary bacterial and fungal infections have increased, perhaps due to immunomodulatory treatments or just the length of time patients spend on ICU recovering from COVID-19. This makes rapid diagnosis even more important to ensure patients get more targeted antibiotics earlier, rather than relying on generic guidelines.”

The team “are planning to move respiratory metagenomics into pilot service under our Trust’s quality improvement framework,” he revealed. This will enable them to gather data on patient benefits.  

“We also need to see how clinicians use these tests to improve antibiotic treatment, to stop antibiotics when not needed or to identify outbreaks earlier, and then how that translates into tangible benefits for individual patients and the wider NHS.”

He predicts that the technique will revolutionize the approach to prevention and treatment of serious infection in ICUs, and it is now planned to offer it as a clinical service for COVID-19 and influenza patients during the coming winter.

In addition, he said: “It can be equally applied to other samples such as tissue fluids and biopsies, including those removed at operation. It therefore has potential to impact on diagnostics for many clinical services, particularly if the progress is maintained at the current pace.”

This article first appeared on Medscape UK/Univadis.

The SARS-CoV-2 pandemic has given added impetus for metagenomic testing using nanopore sequencing to progress from a research tool to routine clinical application. A study led by researchers from Guy’s and St. Thomas’ NHS Foundation Trust has shown the potential for clinical metagenomics to become a same-day test for identifying secondary infection in ventilated ICU patients. Getting results in hours rather than days would help to ensure rapid treatment with the correct antibiotic, minimize unnecessary prescriptions, and thus reduce the growing menace of antimicrobial resistance.

‘SARS-CoV-2 has put considerable strain on ICUs’

The researchers point out that the setting of an intensive care unit involves frequent staff-patient contact that imparts a risk of secondary or nosocomial infection. In addition, invasive ventilation may introduce organisms into the lungs and lead to ventilator-acquired pneumonia. This carries a high mortality and is responsible for up to 70% of antimicrobial prescribing, with current guidelines requiring empiric antibiotics pending culture results, which typically takes 2-4 days.

Many of these infection problems worsened during SARS-CoV-2. Expanded critical care capacity raised the risk of nosocomial infections, with attendant increased antimicrobial prescriptions and the threat of antimicrobial resistance. In addition, treatment of COVID-19 patients with steroid therapy potentially exacerbates bacterial or fungal infections.

The researchers, from the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, in collaboration with the Quadram Institute in Norwich, Oxford Nanopore Technologies, and Viapath, the U.K.’s largest independent pathology service provider, noted that the pandemic thus reinforced “a need for rapid comprehensive diagnostics to improve antimicrobial stewardship and help prevent emergence and transmission of multi-drug-resistant organisms.”

“As soon as the pandemic started, our scientists realized there would be a benefit to sequencing genomes of all bacteria and fungi causing infection in COVID-19 patients while on ICU,” said Professor Jonathan Edgeworth, who led the research team.

“Within a few weeks we showed it can diagnose secondary infection, target antibiotic treatment, and detect outbreaks much earlier than current technologies – all from a single sample.”
 

Proof-of-concept study

The team performed a proof-of-concept study of nanopore metagenomics sequencing – a type of DNA sequencing that allows direct rapid unbiased detection of all organisms present in a clinical sample – on 43 surplus respiratory samples from 34 intubated COVID-19 patients with suspected secondary bacterial or fungal pneumonia. Patients were drawn from seven ICUs at St. Thomas’ Hospital, London over a 9-week period between April 11 and June 15 2020, during the first wave of COVID-19.

Their median age was 52, 70% were male, 47% White, and 44% Black or minority ethnicities. Median length of stay was 32 days and mortality 24%. Samples sent for metagenomic analysis and culture included 10 bronchoalveolar lavages, 6 tracheal aspirates, and 27 non-direct bronchoalveolar lavages.

The study, published in Genome Medicine, showed that an 8-hour metagenomics workflow was 92% sensitive (95% CI, 75% to 99%) and 82% specific (95% CI, 57% to 96%) for bacterial identification, based on culture-positive and culture-negative samples, respectively.

The main Gram-negative bacteria identified were Klebsiella spp. (53%), Citrobacter spp. (15%), and E coli (9%). The main Gram-positive bacteria were S aureus (9%), C striatum (24%) and Enterococcus spp. (12%). In addition, C albicans, other Candida spp. and Aspergillus spp. were cultured from 38%, 15%, and 9% of patients, respectively.

In every case, the initial antibiotics prescribed according to prevailing guideline recommendations would have been modified by metagenomic sequencing demonstrating the presence or absence of β-lactam-resistant genes carried by Enterobacterales.

Next day results of sequencing also detected Aspergillus fumigatus in four samples, with results 100% concordant with quantitative PCR for both the four positive and 39 negative samples. It identified two multi-drug–resistant outbreaks, one involving K pneumoniae ST307 affecting four patients and one a C striatum outbreak involving 14 patients across three ICUs.

Thus, a single sample can provide enough genetic sequence data to compare pathogen genomes with a database and accurately identify patients carrying the same strain, enabling early detection of outbreaks. This is the first time this combined benefit of a single test has been demonstrated, the team say.

Gordon Sanghera, CEO of Oxford Nanopore commented that “rapidly characterizing co-infections for precision prescribing is a vital next step for both COVID-19 patients and respiratory disease in general.”

Dr. Andrew Page of the Quadram Institute said: “We have been working on metagenomics technology for the last 7 years. It is great to see it applied to patient care during the COVID-19 pandemic.”

He said in an interview: “The pandemic has accelerated the transition from using sequencing purely in research labs to using it in the clinic to rapidly provide clinicians with information they can use to improve outcomes for patients.”
 

Potential to inform antimicrobial prescribing and infection control

“Clinical metagenomic testing provides accurate pathogen detection and antibiotic resistance prediction in a same-day laboratory workflow, with assembled genomes available the next day for genomic surveillance,” the researchers say.

The technology “could fundamentally change the multi-disciplinary team approach to managing ICU infections.” It has the potential to improve initial targeted antimicrobial treatment and infection control decisions, as well as help rapidly detect unsuspected outbreaks of multi-drug–resistant pathogens.

Professor Edgeworth told this news organization that since the study, “secondary bacterial and fungal infections have increased, perhaps due to immunomodulatory treatments or just the length of time patients spend on ICU recovering from COVID-19. This makes rapid diagnosis even more important to ensure patients get more targeted antibiotics earlier, rather than relying on generic guidelines.”

The team “are planning to move respiratory metagenomics into pilot service under our Trust’s quality improvement framework,” he revealed. This will enable them to gather data on patient benefits.  

“We also need to see how clinicians use these tests to improve antibiotic treatment, to stop antibiotics when not needed or to identify outbreaks earlier, and then how that translates into tangible benefits for individual patients and the wider NHS.”

He predicts that the technique will revolutionize the approach to prevention and treatment of serious infection in ICUs, and it is now planned to offer it as a clinical service for COVID-19 and influenza patients during the coming winter.

In addition, he said: “It can be equally applied to other samples such as tissue fluids and biopsies, including those removed at operation. It therefore has potential to impact on diagnostics for many clinical services, particularly if the progress is maintained at the current pace.”

This article first appeared on Medscape UK/Univadis.

The SARS-CoV-2 pandemic has given added impetus for metagenomic testing using nanopore sequencing to progress from a research tool to routine clinical application. A study led by researchers from Guy’s and St. Thomas’ NHS Foundation Trust has shown the potential for clinical metagenomics to become a same-day test for identifying secondary infection in ventilated ICU patients. Getting results in hours rather than days would help to ensure rapid treatment with the correct antibiotic, minimize unnecessary prescriptions, and thus reduce the growing menace of antimicrobial resistance.

‘SARS-CoV-2 has put considerable strain on ICUs’

The researchers point out that the setting of an intensive care unit involves frequent staff-patient contact that imparts a risk of secondary or nosocomial infection. In addition, invasive ventilation may introduce organisms into the lungs and lead to ventilator-acquired pneumonia. This carries a high mortality and is responsible for up to 70% of antimicrobial prescribing, with current guidelines requiring empiric antibiotics pending culture results, which typically takes 2-4 days.

Many of these infection problems worsened during SARS-CoV-2. Expanded critical care capacity raised the risk of nosocomial infections, with attendant increased antimicrobial prescriptions and the threat of antimicrobial resistance. In addition, treatment of COVID-19 patients with steroid therapy potentially exacerbates bacterial or fungal infections.

The researchers, from the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, in collaboration with the Quadram Institute in Norwich, Oxford Nanopore Technologies, and Viapath, the U.K.’s largest independent pathology service provider, noted that the pandemic thus reinforced “a need for rapid comprehensive diagnostics to improve antimicrobial stewardship and help prevent emergence and transmission of multi-drug-resistant organisms.”

“As soon as the pandemic started, our scientists realized there would be a benefit to sequencing genomes of all bacteria and fungi causing infection in COVID-19 patients while on ICU,” said Professor Jonathan Edgeworth, who led the research team.

“Within a few weeks we showed it can diagnose secondary infection, target antibiotic treatment, and detect outbreaks much earlier than current technologies – all from a single sample.”
 

Proof-of-concept study

The team performed a proof-of-concept study of nanopore metagenomics sequencing – a type of DNA sequencing that allows direct rapid unbiased detection of all organisms present in a clinical sample – on 43 surplus respiratory samples from 34 intubated COVID-19 patients with suspected secondary bacterial or fungal pneumonia. Patients were drawn from seven ICUs at St. Thomas’ Hospital, London over a 9-week period between April 11 and June 15 2020, during the first wave of COVID-19.

Their median age was 52, 70% were male, 47% White, and 44% Black or minority ethnicities. Median length of stay was 32 days and mortality 24%. Samples sent for metagenomic analysis and culture included 10 bronchoalveolar lavages, 6 tracheal aspirates, and 27 non-direct bronchoalveolar lavages.

The study, published in Genome Medicine, showed that an 8-hour metagenomics workflow was 92% sensitive (95% CI, 75% to 99%) and 82% specific (95% CI, 57% to 96%) for bacterial identification, based on culture-positive and culture-negative samples, respectively.

The main Gram-negative bacteria identified were Klebsiella spp. (53%), Citrobacter spp. (15%), and E coli (9%). The main Gram-positive bacteria were S aureus (9%), C striatum (24%) and Enterococcus spp. (12%). In addition, C albicans, other Candida spp. and Aspergillus spp. were cultured from 38%, 15%, and 9% of patients, respectively.

In every case, the initial antibiotics prescribed according to prevailing guideline recommendations would have been modified by metagenomic sequencing demonstrating the presence or absence of β-lactam-resistant genes carried by Enterobacterales.

Next day results of sequencing also detected Aspergillus fumigatus in four samples, with results 100% concordant with quantitative PCR for both the four positive and 39 negative samples. It identified two multi-drug–resistant outbreaks, one involving K pneumoniae ST307 affecting four patients and one a C striatum outbreak involving 14 patients across three ICUs.

Thus, a single sample can provide enough genetic sequence data to compare pathogen genomes with a database and accurately identify patients carrying the same strain, enabling early detection of outbreaks. This is the first time this combined benefit of a single test has been demonstrated, the team say.

Gordon Sanghera, CEO of Oxford Nanopore commented that “rapidly characterizing co-infections for precision prescribing is a vital next step for both COVID-19 patients and respiratory disease in general.”

Dr. Andrew Page of the Quadram Institute said: “We have been working on metagenomics technology for the last 7 years. It is great to see it applied to patient care during the COVID-19 pandemic.”

He said in an interview: “The pandemic has accelerated the transition from using sequencing purely in research labs to using it in the clinic to rapidly provide clinicians with information they can use to improve outcomes for patients.”
 

Potential to inform antimicrobial prescribing and infection control

“Clinical metagenomic testing provides accurate pathogen detection and antibiotic resistance prediction in a same-day laboratory workflow, with assembled genomes available the next day for genomic surveillance,” the researchers say.

The technology “could fundamentally change the multi-disciplinary team approach to managing ICU infections.” It has the potential to improve initial targeted antimicrobial treatment and infection control decisions, as well as help rapidly detect unsuspected outbreaks of multi-drug–resistant pathogens.

Professor Edgeworth told this news organization that since the study, “secondary bacterial and fungal infections have increased, perhaps due to immunomodulatory treatments or just the length of time patients spend on ICU recovering from COVID-19. This makes rapid diagnosis even more important to ensure patients get more targeted antibiotics earlier, rather than relying on generic guidelines.”

The team “are planning to move respiratory metagenomics into pilot service under our Trust’s quality improvement framework,” he revealed. This will enable them to gather data on patient benefits.  

“We also need to see how clinicians use these tests to improve antibiotic treatment, to stop antibiotics when not needed or to identify outbreaks earlier, and then how that translates into tangible benefits for individual patients and the wider NHS.”

He predicts that the technique will revolutionize the approach to prevention and treatment of serious infection in ICUs, and it is now planned to offer it as a clinical service for COVID-19 and influenza patients during the coming winter.

In addition, he said: “It can be equally applied to other samples such as tissue fluids and biopsies, including those removed at operation. It therefore has potential to impact on diagnostics for many clinical services, particularly if the progress is maintained at the current pace.”

This article first appeared on Medscape UK/Univadis.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

I was recently asked to see a 16-year-old, unvaccinated (against COVID-19) adolescent with hypothyroidism and obesity (body mass index 37 kg/m²) seen in the pediatric emergency department with tachycardia, O₂ saturation 96%, urinary tract infection, poor appetite, and nausea. Her chest x-ray had low lung volumes but no infiltrates. She was noted to be dehydrated. Testing for COVID-19 was PCR positive.¹

She was observed overnight, tolerated oral rehydration, and was being readied for discharge. Pediatric Infectious Diseases was called about prescribing remdesivir.

Remdesivir was not indicated as its current use is limited to inpatients with oxygen desaturations less than 94%. Infectious Diseases Society of America guidelines do recommend the use of monoclonal antibodies against the SARS-CoV-2 spike protein for prevention of COVID disease progression in high-risk individuals. Specifically, the IDSA guidelines say, “Among ambulatory patients with mild to moderate COVID-19 at high risk for progression to severe disease, bamlanivimab/etesevimab, casirivimab/imdevimab, or sotrovimab rather than no neutralizing antibody treatment.”

The Food and Drug Administration’s Emergency Use Authorization (EUA) allowed use of specific monoclonal antibodies (casirivimab/imdevimab in combination, bamlanivimab/etesevimab in combination, and sotrovimab alone) for individuals 12 years and above with a minimum weight of 40 kg with high-risk conditions, describing the evidence as moderate certainty.²

Several questions have arisen regarding their use. Which children qualify under the EUA? Are the available monoclonal antibodies effective for SARS-CoV-2 variants? What adverse events were observed? Are there implementation hurdles?

Unlike the EUA for prophylactic use, which targeted unvaccinated individuals and those unlikely to have a good antibody response to vaccine, use of monoclonal antibody for prevention of progression does not have such restrictions. Effectiveness may vary by local variant susceptibility and should be considered in the choice of the most appropriate monoclonal antibody therapy. Reductions in hospitalization and progression to critical disease status were reported from phase 3 studies; reductions were also observed in mortality in some, but not all, studies. Enhanced viral clearance on day 7 was observed with few subjects having persistent high viral load.

Which children qualify under the EUA? Adolescents 12 years and older and over 40 kg are eligible if a high risk condition is present. High-risk conditions include body mass index at the 85th percentile or higher, immunosuppressive disease, or receipt of immunosuppressive therapies, or baseline (pre-COVID infection) medical-related technological dependence such as tracheostomy or positive pressure ventilation. Additional high-risk conditions are neurodevelopmental disorders, sickle cell disease, congenital or acquired heart disease, asthma, or reactive airway or other chronic respiratory disease that requires daily medication for control, diabetes, chronic kidney disease, or pregnancy.³

Are the available monoclonal antibodies effective for SARS-CoV-2 variants? Of course, this is a critical question and relies on knowledge of the dominant variant in a specific geographic location. The CDC data on which variants are susceptible to which monoclonal therapies were updated as of Oct. 21 online (see Table 1). Local departments of public health often will have current data on the dominant variant in the community. Currently, the dominant variant in the United States is Delta and it is anticipated to be susceptible to the three monoclonal treatments authorized under the EUA based on in vitro neutralizing assays.

Implementation challenges

The first challenge is finding a location to infuse the monoclonal antibodies. Although they can be given subcutaneously, the dose is large and little, if any, time is saved as the recommendation is for observation post administration for 1 hour. The challenge we and other centers may face is that the patients are COVID PCR+ and therefore our usual infusion program, which often is occupied by individuals already compromised and at high risk for severe COVID, is an undesirable location. We are planning to use the emergency department to accommodate such patients currently, but even that solution creates challenges for a busy, urban medical center.

Summary

Anti–SARS-CoV-2 monoclonal antibodies are an important part of the therapeutic approach to minimizing disease severity. Clinicians should review high-risk conditions in adolescents who are PCR+ for SARS-CoV-2 and have mild to moderate symptoms. Medical care systems should implement programs to make monoclonal infusions available for such high-risk adolescents.⁴ Obesity and asthma reactive airways or requiring daily medication for control are the two most common conditions that place adolescents with COVID-19 at risk for progression to hospitalization and severe disease in addition to the more traditional immune-compromising conditions and medical fragility.

Dr. Pelton is professor of pediatrics and epidemiology at Boston University schools of medicine and public health and senior attending physician in pediatric infectious diseases, Boston Medical Center. Email him at [email protected].

References

1. Federal Response to COVID-19: Monoclonal Antibody Clinical Implementation Guide. U.S. Department of Health and Human Services. 2021 Sep 2.

2. Bhimraj A et al. IDSA Guidelines on the Treatment and Management of Patients with COVID-19. Last updated 2021 Nov 9.

3. Anti-SARS-CoV-2 Monoclonal Antibodies. National Institutes of Health’s COVID 19 Treatment Guidelines. Last updated 2021 Oct 19.

4. Spreading the Word on the Benefits of Monoclonal Antibodies for COVID-19, by Hannah R. Buchdahl. CDC Foundation, 2021 Jul 2.

I was recently asked to see a 16-year-old, unvaccinated (against COVID-19) adolescent with hypothyroidism and obesity (body mass index 37 kg/m²) seen in the pediatric emergency department with tachycardia, O₂ saturation 96%, urinary tract infection, poor appetite, and nausea. Her chest x-ray had low lung volumes but no infiltrates. She was noted to be dehydrated. Testing for COVID-19 was PCR positive.¹

She was observed overnight, tolerated oral rehydration, and was being readied for discharge. Pediatric Infectious Diseases was called about prescribing remdesivir.

Remdesivir was not indicated as its current use is limited to inpatients with oxygen desaturations less than 94%. Infectious Diseases Society of America guidelines do recommend the use of monoclonal antibodies against the SARS-CoV-2 spike protein for prevention of COVID disease progression in high-risk individuals. Specifically, the IDSA guidelines say, “Among ambulatory patients with mild to moderate COVID-19 at high risk for progression to severe disease, bamlanivimab/etesevimab, casirivimab/imdevimab, or sotrovimab rather than no neutralizing antibody treatment.”

The Food and Drug Administration’s Emergency Use Authorization (EUA) allowed use of specific monoclonal antibodies (casirivimab/imdevimab in combination, bamlanivimab/etesevimab in combination, and sotrovimab alone) for individuals 12 years and above with a minimum weight of 40 kg with high-risk conditions, describing the evidence as moderate certainty.²

Several questions have arisen regarding their use. Which children qualify under the EUA? Are the available monoclonal antibodies effective for SARS-CoV-2 variants? What adverse events were observed? Are there implementation hurdles?

Unlike the EUA for prophylactic use, which targeted unvaccinated individuals and those unlikely to have a good antibody response to vaccine, use of monoclonal antibody for prevention of progression does not have such restrictions. Effectiveness may vary by local variant susceptibility and should be considered in the choice of the most appropriate monoclonal antibody therapy. Reductions in hospitalization and progression to critical disease status were reported from phase 3 studies; reductions were also observed in mortality in some, but not all, studies. Enhanced viral clearance on day 7 was observed with few subjects having persistent high viral load.

Which children qualify under the EUA? Adolescents 12 years and older and over 40 kg are eligible if a high risk condition is present. High-risk conditions include body mass index at the 85th percentile or higher, immunosuppressive disease, or receipt of immunosuppressive therapies, or baseline (pre-COVID infection) medical-related technological dependence such as tracheostomy or positive pressure ventilation. Additional high-risk conditions are neurodevelopmental disorders, sickle cell disease, congenital or acquired heart disease, asthma, or reactive airway or other chronic respiratory disease that requires daily medication for control, diabetes, chronic kidney disease, or pregnancy.³

Are the available monoclonal antibodies effective for SARS-CoV-2 variants? Of course, this is a critical question and relies on knowledge of the dominant variant in a specific geographic location. The CDC data on which variants are susceptible to which monoclonal therapies were updated as of Oct. 21 online (see Table 1). Local departments of public health often will have current data on the dominant variant in the community. Currently, the dominant variant in the United States is Delta and it is anticipated to be susceptible to the three monoclonal treatments authorized under the EUA based on in vitro neutralizing assays.

Implementation challenges

The first challenge is finding a location to infuse the monoclonal antibodies. Although they can be given subcutaneously, the dose is large and little, if any, time is saved as the recommendation is for observation post administration for 1 hour. The challenge we and other centers may face is that the patients are COVID PCR+ and therefore our usual infusion program, which often is occupied by individuals already compromised and at high risk for severe COVID, is an undesirable location. We are planning to use the emergency department to accommodate such patients currently, but even that solution creates challenges for a busy, urban medical center.

Summary

Anti–SARS-CoV-2 monoclonal antibodies are an important part of the therapeutic approach to minimizing disease severity. Clinicians should review high-risk conditions in adolescents who are PCR+ for SARS-CoV-2 and have mild to moderate symptoms. Medical care systems should implement programs to make monoclonal infusions available for such high-risk adolescents.⁴ Obesity and asthma reactive airways or requiring daily medication for control are the two most common conditions that place adolescents with COVID-19 at risk for progression to hospitalization and severe disease in addition to the more traditional immune-compromising conditions and medical fragility.

Dr. Pelton is professor of pediatrics and epidemiology at Boston University schools of medicine and public health and senior attending physician in pediatric infectious diseases, Boston Medical Center. Email him at [email protected].

References

1. Federal Response to COVID-19: Monoclonal Antibody Clinical Implementation Guide. U.S. Department of Health and Human Services. 2021 Sep 2.

2. Bhimraj A et al. IDSA Guidelines on the Treatment and Management of Patients with COVID-19. Last updated 2021 Nov 9.

3. Anti-SARS-CoV-2 Monoclonal Antibodies. National Institutes of Health’s COVID 19 Treatment Guidelines. Last updated 2021 Oct 19.

4. Spreading the Word on the Benefits of Monoclonal Antibodies for COVID-19, by Hannah R. Buchdahl. CDC Foundation, 2021 Jul 2.

I was recently asked to see a 16-year-old, unvaccinated (against COVID-19) adolescent with hypothyroidism and obesity (body mass index 37 kg/m²) seen in the pediatric emergency department with tachycardia, O₂ saturation 96%, urinary tract infection, poor appetite, and nausea. Her chest x-ray had low lung volumes but no infiltrates. She was noted to be dehydrated. Testing for COVID-19 was PCR positive.¹

She was observed overnight, tolerated oral rehydration, and was being readied for discharge. Pediatric Infectious Diseases was called about prescribing remdesivir.

Remdesivir was not indicated as its current use is limited to inpatients with oxygen desaturations less than 94%. Infectious Diseases Society of America guidelines do recommend the use of monoclonal antibodies against the SARS-CoV-2 spike protein for prevention of COVID disease progression in high-risk individuals. Specifically, the IDSA guidelines say, “Among ambulatory patients with mild to moderate COVID-19 at high risk for progression to severe disease, bamlanivimab/etesevimab, casirivimab/imdevimab, or sotrovimab rather than no neutralizing antibody treatment.”

The Food and Drug Administration’s Emergency Use Authorization (EUA) allowed use of specific monoclonal antibodies (casirivimab/imdevimab in combination, bamlanivimab/etesevimab in combination, and sotrovimab alone) for individuals 12 years and above with a minimum weight of 40 kg with high-risk conditions, describing the evidence as moderate certainty.²

Several questions have arisen regarding their use. Which children qualify under the EUA? Are the available monoclonal antibodies effective for SARS-CoV-2 variants? What adverse events were observed? Are there implementation hurdles?

Unlike the EUA for prophylactic use, which targeted unvaccinated individuals and those unlikely to have a good antibody response to vaccine, use of monoclonal antibody for prevention of progression does not have such restrictions. Effectiveness may vary by local variant susceptibility and should be considered in the choice of the most appropriate monoclonal antibody therapy. Reductions in hospitalization and progression to critical disease status were reported from phase 3 studies; reductions were also observed in mortality in some, but not all, studies. Enhanced viral clearance on day 7 was observed with few subjects having persistent high viral load.

Which children qualify under the EUA? Adolescents 12 years and older and over 40 kg are eligible if a high risk condition is present. High-risk conditions include body mass index at the 85th percentile or higher, immunosuppressive disease, or receipt of immunosuppressive therapies, or baseline (pre-COVID infection) medical-related technological dependence such as tracheostomy or positive pressure ventilation. Additional high-risk conditions are neurodevelopmental disorders, sickle cell disease, congenital or acquired heart disease, asthma, or reactive airway or other chronic respiratory disease that requires daily medication for control, diabetes, chronic kidney disease, or pregnancy.³

Are the available monoclonal antibodies effective for SARS-CoV-2 variants? Of course, this is a critical question and relies on knowledge of the dominant variant in a specific geographic location. The CDC data on which variants are susceptible to which monoclonal therapies were updated as of Oct. 21 online (see Table 1). Local departments of public health often will have current data on the dominant variant in the community. Currently, the dominant variant in the United States is Delta and it is anticipated to be susceptible to the three monoclonal treatments authorized under the EUA based on in vitro neutralizing assays.

Implementation challenges

The first challenge is finding a location to infuse the monoclonal antibodies. Although they can be given subcutaneously, the dose is large and little, if any, time is saved as the recommendation is for observation post administration for 1 hour. The challenge we and other centers may face is that the patients are COVID PCR+ and therefore our usual infusion program, which often is occupied by individuals already compromised and at high risk for severe COVID, is an undesirable location. We are planning to use the emergency department to accommodate such patients currently, but even that solution creates challenges for a busy, urban medical center.

Summary

Anti–SARS-CoV-2 monoclonal antibodies are an important part of the therapeutic approach to minimizing disease severity. Clinicians should review high-risk conditions in adolescents who are PCR+ for SARS-CoV-2 and have mild to moderate symptoms. Medical care systems should implement programs to make monoclonal infusions available for such high-risk adolescents.⁴ Obesity and asthma reactive airways or requiring daily medication for control are the two most common conditions that place adolescents with COVID-19 at risk for progression to hospitalization and severe disease in addition to the more traditional immune-compromising conditions and medical fragility.

Dr. Pelton is professor of pediatrics and epidemiology at Boston University schools of medicine and public health and senior attending physician in pediatric infectious diseases, Boston Medical Center. Email him at [email protected].

References

1. Federal Response to COVID-19: Monoclonal Antibody Clinical Implementation Guide. U.S. Department of Health and Human Services. 2021 Sep 2.

2. Bhimraj A et al. IDSA Guidelines on the Treatment and Management of Patients with COVID-19. Last updated 2021 Nov 9.

3. Anti-SARS-CoV-2 Monoclonal Antibodies. National Institutes of Health’s COVID 19 Treatment Guidelines. Last updated 2021 Oct 19.

4. Spreading the Word on the Benefits of Monoclonal Antibodies for COVID-19, by Hannah R. Buchdahl. CDC Foundation, 2021 Jul 2.

With deer hunting season underway or starting in states across the United States, people should wear a mask and gloves when handling deer to prevent coronavirus transmission, experts say.

A recent study by researchers at Penn State University found that more than 80% of the deer sampled during last year’s hunting season in counties across Iowa tested positive for COVID-19. Overall, a third of the deer sampled between September 2020 and January 2021 tested positive.

“The findings suggest that white-tailed deer may be a reservoir for the virus to continually circulate and raise concerns about the emergence of new strains that may prove a threat to wildlife and, possibly, to humans,” the researchers said in a statement.

The deer were likely infected due to “multiple human-to-deer spillover events and deer-to-deer transmission,” they noted.

Studies haven’t shown whether deer have infected humans, but public health experts are recommending that hunters and deer handlers consider possible transmission avenues, The Plain Dealer, a Cleveland newspaper, reported.

To limit deer-to-deer transmission, homeowners and hunters should avoid concentrating deer at backyard feeders or in hunting situations, according to the Ohio Department of Natural Resources Division of Wildlife. The department also urged people to not allow contact between wildlife and domestic animals, including pets and hunting dogs.

Eating venison shouldn’t be a concern if people cook the meat thoroughly, the newspaper reported. Until more is known, people should wear a mask and gloves when handling deer.

In the study, Penn State researchers examined 283 deer between December 2020 and January 2021. They took samples from lymph nodes in the head and neck as part of Iowa’s chronic wasting disease surveillance program.

“This is the first direct evidence of SARS-CoV-2 virus in any free-living species, and our findings have important implications for the ecology and long-term persistence of the virus,” Suresh Kuchipudi, PhD, associate director of the Animal Diagnostics Laboratory at Penn State, said in the statement.

“These include spillover to other free-living or captive animals and potential spillback to human hosts,” he said. “Of course, this highlights that many urgent steps are needed to monitor the spread of the virus in deer and prevent spillback to humans.”

The research team sequenced genomes from all the positive samples and identified 12 coronavirus lineages. The prominent ones corresponded to the same lineages found in humans at the time.

The U.S. Department of Agriculture has also inspected 480 samples this year from white-tailed deer in Illinois, Michigan, New York, and Pennsylvania. Researchers detected virus antibodies in 33% of samples, according to a statement from the department. The department has confirmed the virus in deer in Ohio as well.

Health officials have recommended that hunters also take precautions while around other people by getting vaccinated and wearing a mask, according to WMTV in Wisconsin.

“If someone comes to deer camp and they have COVID and other folks aren’t vaccinated, in that enclosed space with the laughing and good times that are had, the likelihood that those other hunters would be infected is pretty high,” Jeff Pothof, MD, an emergency medicine doctor at UW Health, told the news outlet.

“I think the biggest risk to deer hunters is going to be other hunters, not so much the deer,” he said.

A version of this article first appeared on Medscape.com.

With deer hunting season underway or starting in states across the United States, people should wear a mask and gloves when handling deer to prevent coronavirus transmission, experts say.

A recent study by researchers at Penn State University found that more than 80% of the deer sampled during last year’s hunting season in counties across Iowa tested positive for COVID-19. Overall, a third of the deer sampled between September 2020 and January 2021 tested positive.

“The findings suggest that white-tailed deer may be a reservoir for the virus to continually circulate and raise concerns about the emergence of new strains that may prove a threat to wildlife and, possibly, to humans,” the researchers said in a statement.

The deer were likely infected due to “multiple human-to-deer spillover events and deer-to-deer transmission,” they noted.

Studies haven’t shown whether deer have infected humans, but public health experts are recommending that hunters and deer handlers consider possible transmission avenues, The Plain Dealer, a Cleveland newspaper, reported.

To limit deer-to-deer transmission, homeowners and hunters should avoid concentrating deer at backyard feeders or in hunting situations, according to the Ohio Department of Natural Resources Division of Wildlife. The department also urged people to not allow contact between wildlife and domestic animals, including pets and hunting dogs.

Eating venison shouldn’t be a concern if people cook the meat thoroughly, the newspaper reported. Until more is known, people should wear a mask and gloves when handling deer.

In the study, Penn State researchers examined 283 deer between December 2020 and January 2021. They took samples from lymph nodes in the head and neck as part of Iowa’s chronic wasting disease surveillance program.

“This is the first direct evidence of SARS-CoV-2 virus in any free-living species, and our findings have important implications for the ecology and long-term persistence of the virus,” Suresh Kuchipudi, PhD, associate director of the Animal Diagnostics Laboratory at Penn State, said in the statement.

“These include spillover to other free-living or captive animals and potential spillback to human hosts,” he said. “Of course, this highlights that many urgent steps are needed to monitor the spread of the virus in deer and prevent spillback to humans.”

The research team sequenced genomes from all the positive samples and identified 12 coronavirus lineages. The prominent ones corresponded to the same lineages found in humans at the time.

The U.S. Department of Agriculture has also inspected 480 samples this year from white-tailed deer in Illinois, Michigan, New York, and Pennsylvania. Researchers detected virus antibodies in 33% of samples, according to a statement from the department. The department has confirmed the virus in deer in Ohio as well.

Health officials have recommended that hunters also take precautions while around other people by getting vaccinated and wearing a mask, according to WMTV in Wisconsin.

“If someone comes to deer camp and they have COVID and other folks aren’t vaccinated, in that enclosed space with the laughing and good times that are had, the likelihood that those other hunters would be infected is pretty high,” Jeff Pothof, MD, an emergency medicine doctor at UW Health, told the news outlet.

“I think the biggest risk to deer hunters is going to be other hunters, not so much the deer,” he said.

A version of this article first appeared on Medscape.com.

With deer hunting season underway or starting in states across the United States, people should wear a mask and gloves when handling deer to prevent coronavirus transmission, experts say.

A recent study by researchers at Penn State University found that more than 80% of the deer sampled during last year’s hunting season in counties across Iowa tested positive for COVID-19. Overall, a third of the deer sampled between September 2020 and January 2021 tested positive.

“The findings suggest that white-tailed deer may be a reservoir for the virus to continually circulate and raise concerns about the emergence of new strains that may prove a threat to wildlife and, possibly, to humans,” the researchers said in a statement.

The deer were likely infected due to “multiple human-to-deer spillover events and deer-to-deer transmission,” they noted.

Studies haven’t shown whether deer have infected humans, but public health experts are recommending that hunters and deer handlers consider possible transmission avenues, The Plain Dealer, a Cleveland newspaper, reported.

To limit deer-to-deer transmission, homeowners and hunters should avoid concentrating deer at backyard feeders or in hunting situations, according to the Ohio Department of Natural Resources Division of Wildlife. The department also urged people to not allow contact between wildlife and domestic animals, including pets and hunting dogs.

Eating venison shouldn’t be a concern if people cook the meat thoroughly, the newspaper reported. Until more is known, people should wear a mask and gloves when handling deer.

In the study, Penn State researchers examined 283 deer between December 2020 and January 2021. They took samples from lymph nodes in the head and neck as part of Iowa’s chronic wasting disease surveillance program.

“This is the first direct evidence of SARS-CoV-2 virus in any free-living species, and our findings have important implications for the ecology and long-term persistence of the virus,” Suresh Kuchipudi, PhD, associate director of the Animal Diagnostics Laboratory at Penn State, said in the statement.

“These include spillover to other free-living or captive animals and potential spillback to human hosts,” he said. “Of course, this highlights that many urgent steps are needed to monitor the spread of the virus in deer and prevent spillback to humans.”

The research team sequenced genomes from all the positive samples and identified 12 coronavirus lineages. The prominent ones corresponded to the same lineages found in humans at the time.

The U.S. Department of Agriculture has also inspected 480 samples this year from white-tailed deer in Illinois, Michigan, New York, and Pennsylvania. Researchers detected virus antibodies in 33% of samples, according to a statement from the department. The department has confirmed the virus in deer in Ohio as well.

Health officials have recommended that hunters also take precautions while around other people by getting vaccinated and wearing a mask, according to WMTV in Wisconsin.

“If someone comes to deer camp and they have COVID and other folks aren’t vaccinated, in that enclosed space with the laughing and good times that are had, the likelihood that those other hunters would be infected is pretty high,” Jeff Pothof, MD, an emergency medicine doctor at UW Health, told the news outlet.

“I think the biggest risk to deer hunters is going to be other hunters, not so much the deer,” he said.

A version of this article first appeared on Medscape.com.