MDedge Rheumatology

It’s an electronic cigarette maker’s dream, but a public health nightmare: The confluence of social isolation and anxiety resulting from the COVID-19 pandemic has the potential to make recent progress against e-cigarette use among teens go up in smoke.

“Stress and worsening mental health issues are well-known predisposing factors for smoking, both in quantity and frequency and in relapse,” said Mary Cataletto, MD, FCCP, clinical professor of pediatrics at New York University Winthrop Hospital, Mineola, during a webinar on e-cigarettes and vaping with asthma in the time of COVID-19, hosted by the Allergy & Asthma Network.

Prior to the pandemic, public health experts appeared to be making inroads into curbing e-cigarette use, according to results of the 2020 National Youth Tobacco Survey, a cross-sectional school-based survey of students from grades 6 to 12.

“In 2020, approximately 1 in 5 high school stu­dents and 1 in 20 middle school students currently used e-cigarettes. By comparison, in 2019, 27.5% of high school students (4.11 million) and 10.5% of middle school students (1.24 million) reported current e-cigarette use,” wrote Brian A. King, PhD, MPH, and colleagues, in an article reporting those results.

“We definitely believe that there was a real decline that occurred up until March. Those data from the National Youth Tobacco Survey were collected prior to youth leaving school settings and prior to the implementation of social distancing and other measures,” said Dr. King, deputy director for research translation in the Office on Smoking and Health within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention.

“That said, the jury’s still out on what’s going to happen with youth use during the coming year, particularly during the COVID-19 pandemic” he said in an interview.
 

Flavor of the moment

Even though the data through March 2020 showed a distinct decline in e-cigarette use, Dr. King and colleagues found that 3.6 million U.S. adolescents still currently used e-cigarettes in 2020; among current users, more than 80% reported using flavored e-cigarettes.

Dr. Cataletto said in an interview that the 2020 National Youth Tobacco Survey continues to report widespread use of flavored e-cigarettes among young smokers despite Food and Drug Administration admonitions to manufacturers and retailers to remove unauthorized e-cigarettes from the market.

On Jan. 2, 2020, the FDA reported a finalized enforcement policy directed against “unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.”

But as Dr. King and other investigators also mentioned in a separate analysis of e-cigarette unit sales, that enforcement policy applies only to prefilled cartridge e-cigarette products, such as those made by JUUL, and that while sales of mint- or fruit-flavored products of this type declined from September 2014 to May 2020, there was an increase in the sale of disposable e-cigarettes with flavors other than menthol or tobacco.

Dr. Cataletto pointed out that this vaping trend has coincided with the COVID-19 pandemic, noting that, on March 13, 2020, just 2 days after the World Health Organization declared that spread of COVID-19 was officially a pandemic, 16 states closed schools, leaving millions of middle school– and high school–age children at loose ends. She said: “This raised a number of concerns. Would students who used e-cigarettes be at increased risk of COVID-19? Would e-cigarette use increase again due to the social isolation and anxiety as predicted for tobacco smokers? How would access and availability impact e-cigarette use?

“It’s possible that use may go down, because youth may have less access to their typical social sources or other manners in which they obtain the product.” Dr. King said. “Alternatively, youth may have more disposable time on their hands and may be open to other sources of access to these products, and so use could increase.”

There is evidence to suggest that the latter scenario may be true, according to investigators who surveyed more than 1,000 Canadian adolescents about alcohol use, binge drinking, cannabis use, and vaping in the 3 weeks directly before and after social distancing measures took effect.

The investigators found that the frequency of both alcohol and cannabis use increased during social isolation, and that, although about half of respondents reported solitary substance use, 32% reported using substances with peers via technology, and 24% reported using substances face to face, despite social distancing mandates, reported Tara M. Dumas, PhD, from Huron University College, London, Ont.

“These authors suggest that teens who feared loss of friendships during quarantine might be more willing to engage in risky behaviors such as face to face substance use to maintain social status, while solitary substance use was related to both COVID19 fears and depressive symptomatology,” Dr. Cataletto said.
 

E-cigarettes and COVID-19

A recent survey of 4,351 adolescents and young adults in the United States showed that a COVID-19 diagnosis was five times more likely among those who had ever used e-cigarettes, seven times more likely among conventional cigarette and e-cigarette uses, and nearly seven times more likely among those who had used both within the past 30 days .

Perhaps not surprisingly, adolescents and young adults with asthma who also vape may be at especially high risk for COVID-19, but the exact effect may be hard to pin down with current levels of evidence.

“Prior to the pandemic we did see both new-onset asthma and asthma exacerbations in teens who reported either vaping or dual use with tobacco products,” Dr. Cataletto said. “However, numbers were small, were confounded by the bias of subspecialty practice, and the onset of the pandemic, which affected not only face-to-face visits but the opportunity to perform pulmonary function testing for a number of months.”

Dr. King noted: “There is an emerging body of science that does indicate that there could be some respiratory risks related to e-cigarette use, particularly among certain populations. ... That said, there’s no conclusive link between e-cigarette use and specific disease outcomes, which typically requires a robust body of different science conducted in multiple settings.”

He said that e-cigarette vapors contain ultrafine particles and heavy metals that can be inhaled deeply into the lungs, both of which have previously been associated with respiratory risk, including complications from asthma.
 

An ounce of prevention

“When it comes to cessation, we do know that about 50% of youth who are using tobacco products including e-cigarettes, want to quit, and about the same proportion make an effort to quit, so there’s certainly a will there, but we don’t clearly have an evidence-based way,” Dr. King said.

Combinations of behavioral interventions including face-to-face consultations and digital or telephone support can be helpful, Dr. Cataletto said, but both she and Dr. King agree that prevention is the most effective method of reducing e-cigarette use among teens and young adults, including peer support and education efforts.

Asked how she gets her patients to report honestly about their habits, Dr. Cataletto acknowledged that “this is a challenge for many kids. Some are unaware that many of the commercially available e-cigarette products contain nicotine and they are not ‘just vaping flavoring.’ Ongoing education is important, and it is happening in schools, in pediatrician’s offices, at home and in the community.”

Dr. Cataletto and Dr. King reported no relevant conflicts of interest. Dr. Cataletto serves on the editorial advisory board for Chest Physician.

It’s an electronic cigarette maker’s dream, but a public health nightmare: The confluence of social isolation and anxiety resulting from the COVID-19 pandemic has the potential to make recent progress against e-cigarette use among teens go up in smoke.

“Stress and worsening mental health issues are well-known predisposing factors for smoking, both in quantity and frequency and in relapse,” said Mary Cataletto, MD, FCCP, clinical professor of pediatrics at New York University Winthrop Hospital, Mineola, during a webinar on e-cigarettes and vaping with asthma in the time of COVID-19, hosted by the Allergy & Asthma Network.

Prior to the pandemic, public health experts appeared to be making inroads into curbing e-cigarette use, according to results of the 2020 National Youth Tobacco Survey, a cross-sectional school-based survey of students from grades 6 to 12.

“In 2020, approximately 1 in 5 high school stu­dents and 1 in 20 middle school students currently used e-cigarettes. By comparison, in 2019, 27.5% of high school students (4.11 million) and 10.5% of middle school students (1.24 million) reported current e-cigarette use,” wrote Brian A. King, PhD, MPH, and colleagues, in an article reporting those results.

“We definitely believe that there was a real decline that occurred up until March. Those data from the National Youth Tobacco Survey were collected prior to youth leaving school settings and prior to the implementation of social distancing and other measures,” said Dr. King, deputy director for research translation in the Office on Smoking and Health within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention.

“That said, the jury’s still out on what’s going to happen with youth use during the coming year, particularly during the COVID-19 pandemic” he said in an interview.
 

Flavor of the moment

Even though the data through March 2020 showed a distinct decline in e-cigarette use, Dr. King and colleagues found that 3.6 million U.S. adolescents still currently used e-cigarettes in 2020; among current users, more than 80% reported using flavored e-cigarettes.

Dr. Cataletto said in an interview that the 2020 National Youth Tobacco Survey continues to report widespread use of flavored e-cigarettes among young smokers despite Food and Drug Administration admonitions to manufacturers and retailers to remove unauthorized e-cigarettes from the market.

On Jan. 2, 2020, the FDA reported a finalized enforcement policy directed against “unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.”

But as Dr. King and other investigators also mentioned in a separate analysis of e-cigarette unit sales, that enforcement policy applies only to prefilled cartridge e-cigarette products, such as those made by JUUL, and that while sales of mint- or fruit-flavored products of this type declined from September 2014 to May 2020, there was an increase in the sale of disposable e-cigarettes with flavors other than menthol or tobacco.

Dr. Cataletto pointed out that this vaping trend has coincided with the COVID-19 pandemic, noting that, on March 13, 2020, just 2 days after the World Health Organization declared that spread of COVID-19 was officially a pandemic, 16 states closed schools, leaving millions of middle school– and high school–age children at loose ends. She said: “This raised a number of concerns. Would students who used e-cigarettes be at increased risk of COVID-19? Would e-cigarette use increase again due to the social isolation and anxiety as predicted for tobacco smokers? How would access and availability impact e-cigarette use?

“It’s possible that use may go down, because youth may have less access to their typical social sources or other manners in which they obtain the product.” Dr. King said. “Alternatively, youth may have more disposable time on their hands and may be open to other sources of access to these products, and so use could increase.”

There is evidence to suggest that the latter scenario may be true, according to investigators who surveyed more than 1,000 Canadian adolescents about alcohol use, binge drinking, cannabis use, and vaping in the 3 weeks directly before and after social distancing measures took effect.

The investigators found that the frequency of both alcohol and cannabis use increased during social isolation, and that, although about half of respondents reported solitary substance use, 32% reported using substances with peers via technology, and 24% reported using substances face to face, despite social distancing mandates, reported Tara M. Dumas, PhD, from Huron University College, London, Ont.

“These authors suggest that teens who feared loss of friendships during quarantine might be more willing to engage in risky behaviors such as face to face substance use to maintain social status, while solitary substance use was related to both COVID19 fears and depressive symptomatology,” Dr. Cataletto said.
 

E-cigarettes and COVID-19

A recent survey of 4,351 adolescents and young adults in the United States showed that a COVID-19 diagnosis was five times more likely among those who had ever used e-cigarettes, seven times more likely among conventional cigarette and e-cigarette uses, and nearly seven times more likely among those who had used both within the past 30 days .

Perhaps not surprisingly, adolescents and young adults with asthma who also vape may be at especially high risk for COVID-19, but the exact effect may be hard to pin down with current levels of evidence.

“Prior to the pandemic we did see both new-onset asthma and asthma exacerbations in teens who reported either vaping or dual use with tobacco products,” Dr. Cataletto said. “However, numbers were small, were confounded by the bias of subspecialty practice, and the onset of the pandemic, which affected not only face-to-face visits but the opportunity to perform pulmonary function testing for a number of months.”

Dr. King noted: “There is an emerging body of science that does indicate that there could be some respiratory risks related to e-cigarette use, particularly among certain populations. ... That said, there’s no conclusive link between e-cigarette use and specific disease outcomes, which typically requires a robust body of different science conducted in multiple settings.”

He said that e-cigarette vapors contain ultrafine particles and heavy metals that can be inhaled deeply into the lungs, both of which have previously been associated with respiratory risk, including complications from asthma.
 

An ounce of prevention

“When it comes to cessation, we do know that about 50% of youth who are using tobacco products including e-cigarettes, want to quit, and about the same proportion make an effort to quit, so there’s certainly a will there, but we don’t clearly have an evidence-based way,” Dr. King said.

Combinations of behavioral interventions including face-to-face consultations and digital or telephone support can be helpful, Dr. Cataletto said, but both she and Dr. King agree that prevention is the most effective method of reducing e-cigarette use among teens and young adults, including peer support and education efforts.

Asked how she gets her patients to report honestly about their habits, Dr. Cataletto acknowledged that “this is a challenge for many kids. Some are unaware that many of the commercially available e-cigarette products contain nicotine and they are not ‘just vaping flavoring.’ Ongoing education is important, and it is happening in schools, in pediatrician’s offices, at home and in the community.”

Dr. Cataletto and Dr. King reported no relevant conflicts of interest. Dr. Cataletto serves on the editorial advisory board for Chest Physician.

It’s an electronic cigarette maker’s dream, but a public health nightmare: The confluence of social isolation and anxiety resulting from the COVID-19 pandemic has the potential to make recent progress against e-cigarette use among teens go up in smoke.

“Stress and worsening mental health issues are well-known predisposing factors for smoking, both in quantity and frequency and in relapse,” said Mary Cataletto, MD, FCCP, clinical professor of pediatrics at New York University Winthrop Hospital, Mineola, during a webinar on e-cigarettes and vaping with asthma in the time of COVID-19, hosted by the Allergy & Asthma Network.

Prior to the pandemic, public health experts appeared to be making inroads into curbing e-cigarette use, according to results of the 2020 National Youth Tobacco Survey, a cross-sectional school-based survey of students from grades 6 to 12.

“In 2020, approximately 1 in 5 high school stu­dents and 1 in 20 middle school students currently used e-cigarettes. By comparison, in 2019, 27.5% of high school students (4.11 million) and 10.5% of middle school students (1.24 million) reported current e-cigarette use,” wrote Brian A. King, PhD, MPH, and colleagues, in an article reporting those results.

“We definitely believe that there was a real decline that occurred up until March. Those data from the National Youth Tobacco Survey were collected prior to youth leaving school settings and prior to the implementation of social distancing and other measures,” said Dr. King, deputy director for research translation in the Office on Smoking and Health within the National Center for Chronic Disease Prevention and Health Promotion at the Centers for Disease Control and Prevention.

“That said, the jury’s still out on what’s going to happen with youth use during the coming year, particularly during the COVID-19 pandemic” he said in an interview.
 

Flavor of the moment

Even though the data through March 2020 showed a distinct decline in e-cigarette use, Dr. King and colleagues found that 3.6 million U.S. adolescents still currently used e-cigarettes in 2020; among current users, more than 80% reported using flavored e-cigarettes.

Dr. Cataletto said in an interview that the 2020 National Youth Tobacco Survey continues to report widespread use of flavored e-cigarettes among young smokers despite Food and Drug Administration admonitions to manufacturers and retailers to remove unauthorized e-cigarettes from the market.

On Jan. 2, 2020, the FDA reported a finalized enforcement policy directed against “unauthorized flavored cartridge-based e-cigarettes that appeal to children, including fruit and mint.”

But as Dr. King and other investigators also mentioned in a separate analysis of e-cigarette unit sales, that enforcement policy applies only to prefilled cartridge e-cigarette products, such as those made by JUUL, and that while sales of mint- or fruit-flavored products of this type declined from September 2014 to May 2020, there was an increase in the sale of disposable e-cigarettes with flavors other than menthol or tobacco.

Dr. Cataletto pointed out that this vaping trend has coincided with the COVID-19 pandemic, noting that, on March 13, 2020, just 2 days after the World Health Organization declared that spread of COVID-19 was officially a pandemic, 16 states closed schools, leaving millions of middle school– and high school–age children at loose ends. She said: “This raised a number of concerns. Would students who used e-cigarettes be at increased risk of COVID-19? Would e-cigarette use increase again due to the social isolation and anxiety as predicted for tobacco smokers? How would access and availability impact e-cigarette use?

“It’s possible that use may go down, because youth may have less access to their typical social sources or other manners in which they obtain the product.” Dr. King said. “Alternatively, youth may have more disposable time on their hands and may be open to other sources of access to these products, and so use could increase.”

There is evidence to suggest that the latter scenario may be true, according to investigators who surveyed more than 1,000 Canadian adolescents about alcohol use, binge drinking, cannabis use, and vaping in the 3 weeks directly before and after social distancing measures took effect.

The investigators found that the frequency of both alcohol and cannabis use increased during social isolation, and that, although about half of respondents reported solitary substance use, 32% reported using substances with peers via technology, and 24% reported using substances face to face, despite social distancing mandates, reported Tara M. Dumas, PhD, from Huron University College, London, Ont.

“These authors suggest that teens who feared loss of friendships during quarantine might be more willing to engage in risky behaviors such as face to face substance use to maintain social status, while solitary substance use was related to both COVID19 fears and depressive symptomatology,” Dr. Cataletto said.
 

E-cigarettes and COVID-19

A recent survey of 4,351 adolescents and young adults in the United States showed that a COVID-19 diagnosis was five times more likely among those who had ever used e-cigarettes, seven times more likely among conventional cigarette and e-cigarette uses, and nearly seven times more likely among those who had used both within the past 30 days .

Perhaps not surprisingly, adolescents and young adults with asthma who also vape may be at especially high risk for COVID-19, but the exact effect may be hard to pin down with current levels of evidence.

“Prior to the pandemic we did see both new-onset asthma and asthma exacerbations in teens who reported either vaping or dual use with tobacco products,” Dr. Cataletto said. “However, numbers were small, were confounded by the bias of subspecialty practice, and the onset of the pandemic, which affected not only face-to-face visits but the opportunity to perform pulmonary function testing for a number of months.”

Dr. King noted: “There is an emerging body of science that does indicate that there could be some respiratory risks related to e-cigarette use, particularly among certain populations. ... That said, there’s no conclusive link between e-cigarette use and specific disease outcomes, which typically requires a robust body of different science conducted in multiple settings.”

He said that e-cigarette vapors contain ultrafine particles and heavy metals that can be inhaled deeply into the lungs, both of which have previously been associated with respiratory risk, including complications from asthma.
 

An ounce of prevention

“When it comes to cessation, we do know that about 50% of youth who are using tobacco products including e-cigarettes, want to quit, and about the same proportion make an effort to quit, so there’s certainly a will there, but we don’t clearly have an evidence-based way,” Dr. King said.

Combinations of behavioral interventions including face-to-face consultations and digital or telephone support can be helpful, Dr. Cataletto said, but both she and Dr. King agree that prevention is the most effective method of reducing e-cigarette use among teens and young adults, including peer support and education efforts.

Asked how she gets her patients to report honestly about their habits, Dr. Cataletto acknowledged that “this is a challenge for many kids. Some are unaware that many of the commercially available e-cigarette products contain nicotine and they are not ‘just vaping flavoring.’ Ongoing education is important, and it is happening in schools, in pediatrician’s offices, at home and in the community.”

Dr. Cataletto and Dr. King reported no relevant conflicts of interest. Dr. Cataletto serves on the editorial advisory board for Chest Physician.

Among the many tolls inflicted on health care workers by COVID-19 is one that is not as easily measured as rates of death or disease, but is no less tangible: moral injury. This is the term by which we describe the psychological, social, and spiritual impact of high-stakes situations that lead to the betrayal or transgression of our own deeply held moral beliefs and values.

The current pandemic has provided innumerable such situations that can increase the risk for moral injury, whether we deal directly with patients infected by the coronavirus or not. Telling family members they cannot visit critically ill loved ones. Delaying code activities, even momentarily, to get fully protected with personal protective equipment. Seeing patients who have delayed their necessary or preventive care. Using video rather than touch to reassure people.

Knowing that we are following guidelines from the Centers for Disease Control and Prevention does not stop our feelings of guilt. The longer this pandemic goes on, the more likely it is that these situations will begin to take a toll on us.

For most of us, being exposed to moral injuries is new; they have historically been most associated with severe traumatic wartime experiences. Soldiers, philosophers, and writers have described the ethical dilemmas inherent in war for as long as recorded history. But the use of this term is a more recent development, which the Moral Injury Project at Syracuse (N.Y.) University describes as probably originating in the Vietnam War–era writings of veteran and peace activist Camillo “Mac” Bica and psychiatrist Jonathan Shay. Examples of wartime events that have been thought to lead to moral injury include: causing the harm or death of civilians, knowingly but without alternatives, or accidentally; failing to provide medical aid to an injured civilian or service member; and following orders that were illegal, immoral, and/or against the rules of engagement or the Geneva Conventions.

However, the occurrence of moral injuries in modern health care is increasingly being reported, primarily as an adverse effect of health care inefficiencies that can contribute to burnout. COVID-19 has now provided an array of additional stressors that can cause moral injuries among health care workers. A recent guidance document on moral injury published by the American Psychiatric Association noted that, in the context of a public health disaster, such as COVID-19, it is sometimes necessary to transition from ordinary standards of care to those more appropriate in a crisis, as in wartime. This forces us all to confront challenging questions for which there may be no clear answers, and to make “lose-lose” choices in which no one involved – patients, family, or clinicians – ends up feeling satisfied or even comfortable.

Moral injuries affect most of us as physicians, as well as our colleagues and families, during this unusual, painful, traumatic, and potentially lethal time. Our lives have been altered significantly, and for many, completely turned upside down by enormous sacrifices and tragic losses. Globally, physicians account for over half of healthcare worker deaths. In the United States alone, over 900 health care workers have died of COVID-19.

Most of us have felt the symptoms of moral injury: frustration, anger, disgust, guilt. A recent report describes three levels of stressors in health care occurring during the pandemic, which are not dissimilar to those wartime events described previously.

• Severe moral stressors, such as the denial of treatment to a COVID-19 patient owing to lack of resources, the inability to provide optimal care to non–COVID-19 patients for many reasons, and concern about passing COVID to loved ones.
• Moderate moral stressors, such as preventing visitors, especially to dying patients, triaging patients for healthcare services with inadequate information, and trying to solve the tension between the need for self-preservation and the need to treat.
• Lower-level but common moral challenges, especially in the community – for example, seeing others not protecting the community by hoarding food, gathering for large parties, and not social distancing or wearing masks. Such stressors lead to frustration and contempt, especially from healthcare workers making personal sacrifices and who may be at risk for infection caused by these behaviors.

Every one of us is affected by these stressors. I certainly am.

What are the outcomes? We know that moral injuries are a risk factor for the development of mental health problems and burnout, and not surprisingly we are seeing that mental health problems, suicidality, and substance use disorders have increased markedly during COVID-19, as recently detailed by the CDC.

• Acknowledge that you, like me, are affected by these stressors. This is not a secret, and you should not be ashamed of your feelings.
• Talk with your colleagues, loved ones, and friends about how you and they are affected. You are not alone. Encourage others to share their thoughts, stories, and feelings.
• Put this topic on your meeting and departmental agendas and discuss these moral issues openly with your colleagues. Allow sufficient time to engage in open dialogue.
• Work out ways of assisting those who are in high-risk situations, especially for moderate to severe injuries. Be supportive toward those affected.
• Modify policies and change rosters and rotate staff between high- and low-stress roles. Protect and support at-risk colleagues.
• Think about difficult ethical decisions in advance so they can be made by groups, not individuals, and certainly not “on the fly.”
• Keep everyone in your workplace constantly informed, especially of impending staff or equipment shortages.
• Maintain your inherent self-care and resilience with rest, good nutrition, sleep, exercise, love, caring, socialization, and work-life balance.
• Be prepared to access the many professional support services available in our community if you are intensely distressed or if the above suggestions are not enough.

Remember, we are in this together and will find strength in each other. This too will pass.

This article first appeared on Medscape.com.

Among the many tolls inflicted on health care workers by COVID-19 is one that is not as easily measured as rates of death or disease, but is no less tangible: moral injury. This is the term by which we describe the psychological, social, and spiritual impact of high-stakes situations that lead to the betrayal or transgression of our own deeply held moral beliefs and values.

The current pandemic has provided innumerable such situations that can increase the risk for moral injury, whether we deal directly with patients infected by the coronavirus or not. Telling family members they cannot visit critically ill loved ones. Delaying code activities, even momentarily, to get fully protected with personal protective equipment. Seeing patients who have delayed their necessary or preventive care. Using video rather than touch to reassure people.

Knowing that we are following guidelines from the Centers for Disease Control and Prevention does not stop our feelings of guilt. The longer this pandemic goes on, the more likely it is that these situations will begin to take a toll on us.

For most of us, being exposed to moral injuries is new; they have historically been most associated with severe traumatic wartime experiences. Soldiers, philosophers, and writers have described the ethical dilemmas inherent in war for as long as recorded history. But the use of this term is a more recent development, which the Moral Injury Project at Syracuse (N.Y.) University describes as probably originating in the Vietnam War–era writings of veteran and peace activist Camillo “Mac” Bica and psychiatrist Jonathan Shay. Examples of wartime events that have been thought to lead to moral injury include: causing the harm or death of civilians, knowingly but without alternatives, or accidentally; failing to provide medical aid to an injured civilian or service member; and following orders that were illegal, immoral, and/or against the rules of engagement or the Geneva Conventions.

However, the occurrence of moral injuries in modern health care is increasingly being reported, primarily as an adverse effect of health care inefficiencies that can contribute to burnout. COVID-19 has now provided an array of additional stressors that can cause moral injuries among health care workers. A recent guidance document on moral injury published by the American Psychiatric Association noted that, in the context of a public health disaster, such as COVID-19, it is sometimes necessary to transition from ordinary standards of care to those more appropriate in a crisis, as in wartime. This forces us all to confront challenging questions for which there may be no clear answers, and to make “lose-lose” choices in which no one involved – patients, family, or clinicians – ends up feeling satisfied or even comfortable.

Moral injuries affect most of us as physicians, as well as our colleagues and families, during this unusual, painful, traumatic, and potentially lethal time. Our lives have been altered significantly, and for many, completely turned upside down by enormous sacrifices and tragic losses. Globally, physicians account for over half of healthcare worker deaths. In the United States alone, over 900 health care workers have died of COVID-19.

Most of us have felt the symptoms of moral injury: frustration, anger, disgust, guilt. A recent report describes three levels of stressors in health care occurring during the pandemic, which are not dissimilar to those wartime events described previously.

• Severe moral stressors, such as the denial of treatment to a COVID-19 patient owing to lack of resources, the inability to provide optimal care to non–COVID-19 patients for many reasons, and concern about passing COVID to loved ones.
• Moderate moral stressors, such as preventing visitors, especially to dying patients, triaging patients for healthcare services with inadequate information, and trying to solve the tension between the need for self-preservation and the need to treat.
• Lower-level but common moral challenges, especially in the community – for example, seeing others not protecting the community by hoarding food, gathering for large parties, and not social distancing or wearing masks. Such stressors lead to frustration and contempt, especially from healthcare workers making personal sacrifices and who may be at risk for infection caused by these behaviors.

Every one of us is affected by these stressors. I certainly am.

What are the outcomes? We know that moral injuries are a risk factor for the development of mental health problems and burnout, and not surprisingly we are seeing that mental health problems, suicidality, and substance use disorders have increased markedly during COVID-19, as recently detailed by the CDC.

• Acknowledge that you, like me, are affected by these stressors. This is not a secret, and you should not be ashamed of your feelings.
• Talk with your colleagues, loved ones, and friends about how you and they are affected. You are not alone. Encourage others to share their thoughts, stories, and feelings.
• Put this topic on your meeting and departmental agendas and discuss these moral issues openly with your colleagues. Allow sufficient time to engage in open dialogue.
• Work out ways of assisting those who are in high-risk situations, especially for moderate to severe injuries. Be supportive toward those affected.
• Modify policies and change rosters and rotate staff between high- and low-stress roles. Protect and support at-risk colleagues.
• Think about difficult ethical decisions in advance so they can be made by groups, not individuals, and certainly not “on the fly.”
• Keep everyone in your workplace constantly informed, especially of impending staff or equipment shortages.
• Maintain your inherent self-care and resilience with rest, good nutrition, sleep, exercise, love, caring, socialization, and work-life balance.
• Be prepared to access the many professional support services available in our community if you are intensely distressed or if the above suggestions are not enough.

Remember, we are in this together and will find strength in each other. This too will pass.

This article first appeared on Medscape.com.

Among the many tolls inflicted on health care workers by COVID-19 is one that is not as easily measured as rates of death or disease, but is no less tangible: moral injury. This is the term by which we describe the psychological, social, and spiritual impact of high-stakes situations that lead to the betrayal or transgression of our own deeply held moral beliefs and values.

The current pandemic has provided innumerable such situations that can increase the risk for moral injury, whether we deal directly with patients infected by the coronavirus or not. Telling family members they cannot visit critically ill loved ones. Delaying code activities, even momentarily, to get fully protected with personal protective equipment. Seeing patients who have delayed their necessary or preventive care. Using video rather than touch to reassure people.

Knowing that we are following guidelines from the Centers for Disease Control and Prevention does not stop our feelings of guilt. The longer this pandemic goes on, the more likely it is that these situations will begin to take a toll on us.

For most of us, being exposed to moral injuries is new; they have historically been most associated with severe traumatic wartime experiences. Soldiers, philosophers, and writers have described the ethical dilemmas inherent in war for as long as recorded history. But the use of this term is a more recent development, which the Moral Injury Project at Syracuse (N.Y.) University describes as probably originating in the Vietnam War–era writings of veteran and peace activist Camillo “Mac” Bica and psychiatrist Jonathan Shay. Examples of wartime events that have been thought to lead to moral injury include: causing the harm or death of civilians, knowingly but without alternatives, or accidentally; failing to provide medical aid to an injured civilian or service member; and following orders that were illegal, immoral, and/or against the rules of engagement or the Geneva Conventions.

However, the occurrence of moral injuries in modern health care is increasingly being reported, primarily as an adverse effect of health care inefficiencies that can contribute to burnout. COVID-19 has now provided an array of additional stressors that can cause moral injuries among health care workers. A recent guidance document on moral injury published by the American Psychiatric Association noted that, in the context of a public health disaster, such as COVID-19, it is sometimes necessary to transition from ordinary standards of care to those more appropriate in a crisis, as in wartime. This forces us all to confront challenging questions for which there may be no clear answers, and to make “lose-lose” choices in which no one involved – patients, family, or clinicians – ends up feeling satisfied or even comfortable.

Moral injuries affect most of us as physicians, as well as our colleagues and families, during this unusual, painful, traumatic, and potentially lethal time. Our lives have been altered significantly, and for many, completely turned upside down by enormous sacrifices and tragic losses. Globally, physicians account for over half of healthcare worker deaths. In the United States alone, over 900 health care workers have died of COVID-19.

Most of us have felt the symptoms of moral injury: frustration, anger, disgust, guilt. A recent report describes three levels of stressors in health care occurring during the pandemic, which are not dissimilar to those wartime events described previously.

• Severe moral stressors, such as the denial of treatment to a COVID-19 patient owing to lack of resources, the inability to provide optimal care to non–COVID-19 patients for many reasons, and concern about passing COVID to loved ones.
• Moderate moral stressors, such as preventing visitors, especially to dying patients, triaging patients for healthcare services with inadequate information, and trying to solve the tension between the need for self-preservation and the need to treat.
• Lower-level but common moral challenges, especially in the community – for example, seeing others not protecting the community by hoarding food, gathering for large parties, and not social distancing or wearing masks. Such stressors lead to frustration and contempt, especially from healthcare workers making personal sacrifices and who may be at risk for infection caused by these behaviors.

Every one of us is affected by these stressors. I certainly am.

What are the outcomes? We know that moral injuries are a risk factor for the development of mental health problems and burnout, and not surprisingly we are seeing that mental health problems, suicidality, and substance use disorders have increased markedly during COVID-19, as recently detailed by the CDC.

• Acknowledge that you, like me, are affected by these stressors. This is not a secret, and you should not be ashamed of your feelings.
• Talk with your colleagues, loved ones, and friends about how you and they are affected. You are not alone. Encourage others to share their thoughts, stories, and feelings.
• Put this topic on your meeting and departmental agendas and discuss these moral issues openly with your colleagues. Allow sufficient time to engage in open dialogue.
• Work out ways of assisting those who are in high-risk situations, especially for moderate to severe injuries. Be supportive toward those affected.
• Modify policies and change rosters and rotate staff between high- and low-stress roles. Protect and support at-risk colleagues.
• Think about difficult ethical decisions in advance so they can be made by groups, not individuals, and certainly not “on the fly.”
• Keep everyone in your workplace constantly informed, especially of impending staff or equipment shortages.
• Maintain your inherent self-care and resilience with rest, good nutrition, sleep, exercise, love, caring, socialization, and work-life balance.
• Be prepared to access the many professional support services available in our community if you are intensely distressed or if the above suggestions are not enough.

Remember, we are in this together and will find strength in each other. This too will pass.

This article first appeared on Medscape.com.

Few patient characteristics of men and women with nonradiographic axial spondyloarthritis (nr-axSpA) appear to differ, yet women with the condition have a significantly lower response rate to treatment with tumor necrosis factor (TNF) inhibitors, according to results from a prospective cohort study.

Despite these similarities between the sexes, first author Regula Neuenschwander of the department of rheumatology at Zurich University Hospital and colleagues reported in Arthritis Research & Therapy that women treated with a TNF inhibitor were 81% less likely than men to have a 40% or greater improvement on Assessment of Spondyloarthritis International Society (ASAS) response criteria by 1 year. Statistically significant differences at baseline included women’s longer time to nr-axSpA diagnosis, slightly lower HLA-B27 positivity rate, higher mean baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score, higher rate of current enthesitis, and lower mean body mass index (BMI).

With radiographic disease, women have been reported to more often “present with higher self-reported disease activity and functional impairment, a lower quality of life, less severe spinal radiographic changes, and more peripheral disease (arthritis and enthesitis),” whereas men more often have “objective markers of inflammation, such as elevated C-reactive protein (CRP) levels and magnetic resonance imaging (MRI) inflammation of the axial skeleton,” the researchers wrote. Radiographic disease also tends to occur more often in men, and some studies have reported men to have a greater response to TNF inhibitors. However, the current study sought to understand whether these differences between sexes exist in patients with nonradiographic disease.

The researchers included 495 patients (231 men and 264 women) with a clinical diagnosis of nr-axSpA in the Swiss Clinical Quality Management cohort during 2005-2018 who fulfilled ASAS classification criteria for axSpA and lacked definite radiographic sacroiliac joint changes according to the modified New York criteria. The radiographs were centrally digitized and independently scored in a blinded manner by a rotating group of two readers (out of six total).

Both women and men had a mean age of around 28 years at symptom onset, but women had a significantly longer diagnostic delay of 6.0 years vs. 4.7 years. Also, women were significantly less likely to be HLA-B27 positive (67.0% vs. 76.5%) and had a significantly higher mean BASDAI score at baseline (5.3 vs. 4.6). More women than men also showed signs of current enthesitis (79.6% vs. 64.0%), and women had a lower mean BMI (24.3 vs. 25.7 kg/m²). Concomitant clinically diagnosed fibromyalgia was higher in women than in men (13.1% vs. 2.7%), and when patients with fibromylagia (n = 25) were excluded the remaining differences in BASDAI were mainly because of fatigue and enthesitis, both of which occurred more often in women than in men.

A total of 163 patients without fibromyalgia started a first TNF inhibitor, and 120 had a follow-up visit at 1 year. An ASAS40 response is defined as 40% improvement in at least three of four domains on the ASAS response criteria: patient global assessment of disease activity for the past week, patient assessment of back pain over the past week, function (as assessed on the Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of BASDAI questions 5 and 6). An ASAS40 response was achieved by 17% of women and 38% of men (odds ratio, 0.34; 95% confidence interval, 0.12-0.93), and this difference became more pronounced after adjustment for baseline differences in BASDAI, Maastricht Ankylosing Spondylitis Enthesitis Score, BMI, and diagnostic delay (OR, 0.19; 95% CI, 0.05-0.61). ASAS40 response rates were lower for patients with higher BMI but better for those with higher BASDAI levels. The researchers found comparable results when they excluded patients who stopped a TNF inhibitor because of other reasons for discontinuation and also when they counted patients who discontinued the TNF inhibitor because of remission as responders.

The sex difference in nr-axSpA patients’ treatment response to TNF inhibitors was even larger than the 56% lower odds the same group of researchers reported finding between women and men with radiographic disease in an earlier report, according to the new paper.

Given that this study and others in nr-axSpA patients have found higher remission rates to TNF inhibitor therapy in men versus women, the “current study therefore adds to available data to support the claim for future randomized controlled trials in axSpA to be sufficiently powered to detect potential sex differences,” the researchers said.

The authors acknowledged that a lack of MRI scans available for central scoring made it impossible to evaluate potential imaging misinterpretation, such as possible abnormalities mimicking mild sacroiliitis that have been reported to be more prevalent in women. It is also possible that some patients with fibromyalgia were missed because of screening for the condition by expert opinion of the treating rheumatologist “on a comorbidity questionnaire and not through fulfillment of classification criteria for fibromyalgia or via the use of a standardized fibromyalgia questionnaire,” they said.

The study was funded by the Stiftung für Rheumaforschung in Zurich. The Swiss Clinical Quality Management Foundation is supported by the Swiss Society of Rheumatology and by 11 pharmaceutical companies. Two study authors reported receiving consulting and/or speaking fees from some of those same companies.

[email protected]

SOURCE: Neuenschwander R et al. Arthritis Res Ther. 2020;22(1):233.

Few patient characteristics of men and women with nonradiographic axial spondyloarthritis (nr-axSpA) appear to differ, yet women with the condition have a significantly lower response rate to treatment with tumor necrosis factor (TNF) inhibitors, according to results from a prospective cohort study.

Despite these similarities between the sexes, first author Regula Neuenschwander of the department of rheumatology at Zurich University Hospital and colleagues reported in Arthritis Research & Therapy that women treated with a TNF inhibitor were 81% less likely than men to have a 40% or greater improvement on Assessment of Spondyloarthritis International Society (ASAS) response criteria by 1 year. Statistically significant differences at baseline included women’s longer time to nr-axSpA diagnosis, slightly lower HLA-B27 positivity rate, higher mean baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score, higher rate of current enthesitis, and lower mean body mass index (BMI).

With radiographic disease, women have been reported to more often “present with higher self-reported disease activity and functional impairment, a lower quality of life, less severe spinal radiographic changes, and more peripheral disease (arthritis and enthesitis),” whereas men more often have “objective markers of inflammation, such as elevated C-reactive protein (CRP) levels and magnetic resonance imaging (MRI) inflammation of the axial skeleton,” the researchers wrote. Radiographic disease also tends to occur more often in men, and some studies have reported men to have a greater response to TNF inhibitors. However, the current study sought to understand whether these differences between sexes exist in patients with nonradiographic disease.

The researchers included 495 patients (231 men and 264 women) with a clinical diagnosis of nr-axSpA in the Swiss Clinical Quality Management cohort during 2005-2018 who fulfilled ASAS classification criteria for axSpA and lacked definite radiographic sacroiliac joint changes according to the modified New York criteria. The radiographs were centrally digitized and independently scored in a blinded manner by a rotating group of two readers (out of six total).

Both women and men had a mean age of around 28 years at symptom onset, but women had a significantly longer diagnostic delay of 6.0 years vs. 4.7 years. Also, women were significantly less likely to be HLA-B27 positive (67.0% vs. 76.5%) and had a significantly higher mean BASDAI score at baseline (5.3 vs. 4.6). More women than men also showed signs of current enthesitis (79.6% vs. 64.0%), and women had a lower mean BMI (24.3 vs. 25.7 kg/m²). Concomitant clinically diagnosed fibromyalgia was higher in women than in men (13.1% vs. 2.7%), and when patients with fibromylagia (n = 25) were excluded the remaining differences in BASDAI were mainly because of fatigue and enthesitis, both of which occurred more often in women than in men.

A total of 163 patients without fibromyalgia started a first TNF inhibitor, and 120 had a follow-up visit at 1 year. An ASAS40 response is defined as 40% improvement in at least three of four domains on the ASAS response criteria: patient global assessment of disease activity for the past week, patient assessment of back pain over the past week, function (as assessed on the Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of BASDAI questions 5 and 6). An ASAS40 response was achieved by 17% of women and 38% of men (odds ratio, 0.34; 95% confidence interval, 0.12-0.93), and this difference became more pronounced after adjustment for baseline differences in BASDAI, Maastricht Ankylosing Spondylitis Enthesitis Score, BMI, and diagnostic delay (OR, 0.19; 95% CI, 0.05-0.61). ASAS40 response rates were lower for patients with higher BMI but better for those with higher BASDAI levels. The researchers found comparable results when they excluded patients who stopped a TNF inhibitor because of other reasons for discontinuation and also when they counted patients who discontinued the TNF inhibitor because of remission as responders.

The sex difference in nr-axSpA patients’ treatment response to TNF inhibitors was even larger than the 56% lower odds the same group of researchers reported finding between women and men with radiographic disease in an earlier report, according to the new paper.

Given that this study and others in nr-axSpA patients have found higher remission rates to TNF inhibitor therapy in men versus women, the “current study therefore adds to available data to support the claim for future randomized controlled trials in axSpA to be sufficiently powered to detect potential sex differences,” the researchers said.

The authors acknowledged that a lack of MRI scans available for central scoring made it impossible to evaluate potential imaging misinterpretation, such as possible abnormalities mimicking mild sacroiliitis that have been reported to be more prevalent in women. It is also possible that some patients with fibromyalgia were missed because of screening for the condition by expert opinion of the treating rheumatologist “on a comorbidity questionnaire and not through fulfillment of classification criteria for fibromyalgia or via the use of a standardized fibromyalgia questionnaire,” they said.

The study was funded by the Stiftung für Rheumaforschung in Zurich. The Swiss Clinical Quality Management Foundation is supported by the Swiss Society of Rheumatology and by 11 pharmaceutical companies. Two study authors reported receiving consulting and/or speaking fees from some of those same companies.

[email protected]

SOURCE: Neuenschwander R et al. Arthritis Res Ther. 2020;22(1):233.

Few patient characteristics of men and women with nonradiographic axial spondyloarthritis (nr-axSpA) appear to differ, yet women with the condition have a significantly lower response rate to treatment with tumor necrosis factor (TNF) inhibitors, according to results from a prospective cohort study.

Despite these similarities between the sexes, first author Regula Neuenschwander of the department of rheumatology at Zurich University Hospital and colleagues reported in Arthritis Research & Therapy that women treated with a TNF inhibitor were 81% less likely than men to have a 40% or greater improvement on Assessment of Spondyloarthritis International Society (ASAS) response criteria by 1 year. Statistically significant differences at baseline included women’s longer time to nr-axSpA diagnosis, slightly lower HLA-B27 positivity rate, higher mean baseline Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score, higher rate of current enthesitis, and lower mean body mass index (BMI).

With radiographic disease, women have been reported to more often “present with higher self-reported disease activity and functional impairment, a lower quality of life, less severe spinal radiographic changes, and more peripheral disease (arthritis and enthesitis),” whereas men more often have “objective markers of inflammation, such as elevated C-reactive protein (CRP) levels and magnetic resonance imaging (MRI) inflammation of the axial skeleton,” the researchers wrote. Radiographic disease also tends to occur more often in men, and some studies have reported men to have a greater response to TNF inhibitors. However, the current study sought to understand whether these differences between sexes exist in patients with nonradiographic disease.

The researchers included 495 patients (231 men and 264 women) with a clinical diagnosis of nr-axSpA in the Swiss Clinical Quality Management cohort during 2005-2018 who fulfilled ASAS classification criteria for axSpA and lacked definite radiographic sacroiliac joint changes according to the modified New York criteria. The radiographs were centrally digitized and independently scored in a blinded manner by a rotating group of two readers (out of six total).

Both women and men had a mean age of around 28 years at symptom onset, but women had a significantly longer diagnostic delay of 6.0 years vs. 4.7 years. Also, women were significantly less likely to be HLA-B27 positive (67.0% vs. 76.5%) and had a significantly higher mean BASDAI score at baseline (5.3 vs. 4.6). More women than men also showed signs of current enthesitis (79.6% vs. 64.0%), and women had a lower mean BMI (24.3 vs. 25.7 kg/m²). Concomitant clinically diagnosed fibromyalgia was higher in women than in men (13.1% vs. 2.7%), and when patients with fibromylagia (n = 25) were excluded the remaining differences in BASDAI were mainly because of fatigue and enthesitis, both of which occurred more often in women than in men.

A total of 163 patients without fibromyalgia started a first TNF inhibitor, and 120 had a follow-up visit at 1 year. An ASAS40 response is defined as 40% improvement in at least three of four domains on the ASAS response criteria: patient global assessment of disease activity for the past week, patient assessment of back pain over the past week, function (as assessed on the Bath Ankylosing Spondylitis Functional Index [BASFI]), and inflammation (mean of BASDAI questions 5 and 6). An ASAS40 response was achieved by 17% of women and 38% of men (odds ratio, 0.34; 95% confidence interval, 0.12-0.93), and this difference became more pronounced after adjustment for baseline differences in BASDAI, Maastricht Ankylosing Spondylitis Enthesitis Score, BMI, and diagnostic delay (OR, 0.19; 95% CI, 0.05-0.61). ASAS40 response rates were lower for patients with higher BMI but better for those with higher BASDAI levels. The researchers found comparable results when they excluded patients who stopped a TNF inhibitor because of other reasons for discontinuation and also when they counted patients who discontinued the TNF inhibitor because of remission as responders.

The sex difference in nr-axSpA patients’ treatment response to TNF inhibitors was even larger than the 56% lower odds the same group of researchers reported finding between women and men with radiographic disease in an earlier report, according to the new paper.

Given that this study and others in nr-axSpA patients have found higher remission rates to TNF inhibitor therapy in men versus women, the “current study therefore adds to available data to support the claim for future randomized controlled trials in axSpA to be sufficiently powered to detect potential sex differences,” the researchers said.

The authors acknowledged that a lack of MRI scans available for central scoring made it impossible to evaluate potential imaging misinterpretation, such as possible abnormalities mimicking mild sacroiliitis that have been reported to be more prevalent in women. It is also possible that some patients with fibromyalgia were missed because of screening for the condition by expert opinion of the treating rheumatologist “on a comorbidity questionnaire and not through fulfillment of classification criteria for fibromyalgia or via the use of a standardized fibromyalgia questionnaire,” they said.

The study was funded by the Stiftung für Rheumaforschung in Zurich. The Swiss Clinical Quality Management Foundation is supported by the Swiss Society of Rheumatology and by 11 pharmaceutical companies. Two study authors reported receiving consulting and/or speaking fees from some of those same companies.

[email protected]

SOURCE: Neuenschwander R et al. Arthritis Res Ther. 2020;22(1):233.

Patients with systemic sclerosis have variable disease progression but often experience debilitating fatigue, pain, and digestive issues – and they’re extremely concerned about progressive organ damage, according to those who spoke at and provided input at a public meeting on patient-focused drug development for the disease.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The virtual meeting was part of the Food and Drug Administration’s Patient-Focused Drug Development (PFDD) initiative, which began in 2012 and aims to provide a systematic way for patients’ experiences, needs, and priorities to be “captured and meaningfully incorporated” into drug development and evaluation.
 

Patients rate their most impactful symptoms

Dinesh Khanna, MBBS, MSc, a rheumatologist who directs a scleroderma research program at the University of Michigan, Ann Arbor, attended the meeting after giving an opening presentation on the disease to FDA officials, patients, and other participants. In a later interview, he said that patients’ ratings of their most impactful symptoms was especially striking.

Raynaud’s phenomenon, digestive symptoms, and fatigue were the top three answers to a poll question that asked patients what symptom had the most significant impact on daily life, he noted, “and none of these are being [strongly] addressed right now [in clinical trials] apart from Raynaud’s phenomenon, for which there are some trials ongoing.”

He and other researchers are “struggling with what outcomes measures to use [in their studies],” said Dr. Khanna, the Frederick G.L. Huetwell Professor of Rheumatology at the University. “My takeaway from the meeting as a clinical trialist is that we should be paying close attention to the symptoms that patients tell us are the most important. We should be including these in our trial designs as secondary endpoints, if not primary endpoints. We have not done that [thus far], really.”

Approximately 200,000 patients in the United States have scleroderma, and approximately 75,000-80,000 of these patients have systemic scleroderma, or systemic sclerosis, Dr. Khanna said in his opening presentation. Each year, he estimates, about 6,000 new diagnoses of systemic sclerosis are made.

More than 200 people – patients, FDA officials, and others – participated in the PFDD meeting. Patients participated in one of two panels – one focused on health effects and daily impacts, and the other on treatments – or submitted input electronically. All were invited to answer poll questions.

Raj Nair, MD, one of eight FDA leaders attending the meeting, noted in closing remarks that the pain experienced by patients with systemic sclerosis includes severe pain from Raynaud’s phenomenon and pain caused by digital ulcers and by calcinosis. “We heard about how paralyzing the pain from calcinosis is, and that there are very few options for alleviating this pain,” said Dr. Nair, of the division of rheumatology and transplant medicine.

Another takeaway, he said, is that the “fatigue can be severe and debilitating, leading to days where it is impossible to get out of bed,” and that digestive symptoms can also be severe. “Reflux,” he noted, “requires significant medical intervention.”
 

Patients describe their experiences

Rosemary Lyons, diagnosed with scleroderma 35 years ago, explained that while her skin is no longer hardened, she is overly sensitive to fabrics and skin care products and has difficulty with sleeping and eating. She moved away from family in the Northeast to live in the South where the climate is warmer, but even on a 90-degree night she needs a blanket and two comforters to curb the cold and attempt to sleep.

Impaired gastrointestinal motility has made food her “biggest problem” for the past 10 years, and because of GI symptoms, she can eat only one meal a day. She also experiences fainting, brain fog, and severe fatigue. On a good day, Ms. Lyons noted, she sometimes opts to do some house chores “knowing that I’ll have 1-3 days of recovery.”

Another patient, Amy Harding, said that 22 years after her scleroderma diagnosis, “the calcinosis I get in my fingers, elbows, toes, and ears tops all the prior symptoms.” The skin tightening and digital ulcers that she experienced in the first 10 years have tapered off, and while Raynaud’s symptoms and heartburn have worsened, they are at least partly manageable with medications, unlike the pain from calcinosis.
 

Treating symptoms vs. disease may be key in risk-benefit analysis

In questions after patient presentations, FDA officials probed for more perspective on issues such as how fatigue should be assessed, the differences between fatigue and brain fog, the impact of calcinosis on functioning, and how much risk patients would be willing to assume from treatments that have side effects and that may or may not modulate the disease and slow disease progression.

Most patients said in response to an FDA poll question that they definitely (almost 40%) or possibly (almost 50%) would be willing to try a hypothetical new self-injectable medication if it were shown to reduce their most impactful symptoms but had side effects.

“I think what [we’ve been hearing] today is that whether we’re working on the symptoms or the disease itself is [the key]” to patients’ risk-benefit analysis, said meeting moderator Capt. Robyn Bent, RN, MS, of the U.S. Public Health Service, and director of the PFDD.

Anita Devine, diagnosed 13 years ago with systemic sclerosis, was one of several panel members who said she would accept more bothersome treatment side effects and risks “if the gain was control of disease progression and overall quality of life ... and organ preservation.” Ms. Devine, who has needed kidney dialysis and multiple hand surgeries, noted that she previously took anti-neoplastic and anti-inflammatory agents “to try to stem the course of my disease, but unfortunately the disease did not abate.”

Treatments for systemic sclerosis include vasodilators, immunosuppressive medications, antifibrotic therapies, and stem cell transplants, Dr. Khanna said in his opening remarks.

Trials of drugs for scleroderma have focused on early disease that may be amenable to treatment, with the exception of trials for pulmonary arterial hypertension, which affects some patients with systemic sclerosis. There are multiple FDA-approved drugs for pulmonary arterial hypertension and more trials are underway.

Outcomes such as pain and fatigue are included in many of the trials currently underway, but they tend to be lower-level secondary outcomes measures that cannot be incorporated into drug labeling or are more “exploratory in nature,” Dr. Khanna said in the interview.

Dr. Khanna disclosed that he is the chief medical officer (an equity position) for CiVi Biopharma/Eicos Sciences Inc., which is developing a drug for Raynaud’s, and serves as a consultant and grant recipient for numerous companies that make or are developing drugs for systemic sclerosis.

The FDA will accept patient comments until Dec. 15, 2020, at which time comments will be compiled into a summary report, Ms. Bent said.

Patients with systemic sclerosis have variable disease progression but often experience debilitating fatigue, pain, and digestive issues – and they’re extremely concerned about progressive organ damage, according to those who spoke at and provided input at a public meeting on patient-focused drug development for the disease.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The virtual meeting was part of the Food and Drug Administration’s Patient-Focused Drug Development (PFDD) initiative, which began in 2012 and aims to provide a systematic way for patients’ experiences, needs, and priorities to be “captured and meaningfully incorporated” into drug development and evaluation.
 

Patients rate their most impactful symptoms

Dinesh Khanna, MBBS, MSc, a rheumatologist who directs a scleroderma research program at the University of Michigan, Ann Arbor, attended the meeting after giving an opening presentation on the disease to FDA officials, patients, and other participants. In a later interview, he said that patients’ ratings of their most impactful symptoms was especially striking.

Raynaud’s phenomenon, digestive symptoms, and fatigue were the top three answers to a poll question that asked patients what symptom had the most significant impact on daily life, he noted, “and none of these are being [strongly] addressed right now [in clinical trials] apart from Raynaud’s phenomenon, for which there are some trials ongoing.”

He and other researchers are “struggling with what outcomes measures to use [in their studies],” said Dr. Khanna, the Frederick G.L. Huetwell Professor of Rheumatology at the University. “My takeaway from the meeting as a clinical trialist is that we should be paying close attention to the symptoms that patients tell us are the most important. We should be including these in our trial designs as secondary endpoints, if not primary endpoints. We have not done that [thus far], really.”

Approximately 200,000 patients in the United States have scleroderma, and approximately 75,000-80,000 of these patients have systemic scleroderma, or systemic sclerosis, Dr. Khanna said in his opening presentation. Each year, he estimates, about 6,000 new diagnoses of systemic sclerosis are made.

More than 200 people – patients, FDA officials, and others – participated in the PFDD meeting. Patients participated in one of two panels – one focused on health effects and daily impacts, and the other on treatments – or submitted input electronically. All were invited to answer poll questions.

Raj Nair, MD, one of eight FDA leaders attending the meeting, noted in closing remarks that the pain experienced by patients with systemic sclerosis includes severe pain from Raynaud’s phenomenon and pain caused by digital ulcers and by calcinosis. “We heard about how paralyzing the pain from calcinosis is, and that there are very few options for alleviating this pain,” said Dr. Nair, of the division of rheumatology and transplant medicine.

Another takeaway, he said, is that the “fatigue can be severe and debilitating, leading to days where it is impossible to get out of bed,” and that digestive symptoms can also be severe. “Reflux,” he noted, “requires significant medical intervention.”
 

Patients describe their experiences

Rosemary Lyons, diagnosed with scleroderma 35 years ago, explained that while her skin is no longer hardened, she is overly sensitive to fabrics and skin care products and has difficulty with sleeping and eating. She moved away from family in the Northeast to live in the South where the climate is warmer, but even on a 90-degree night she needs a blanket and two comforters to curb the cold and attempt to sleep.

Impaired gastrointestinal motility has made food her “biggest problem” for the past 10 years, and because of GI symptoms, she can eat only one meal a day. She also experiences fainting, brain fog, and severe fatigue. On a good day, Ms. Lyons noted, she sometimes opts to do some house chores “knowing that I’ll have 1-3 days of recovery.”

Another patient, Amy Harding, said that 22 years after her scleroderma diagnosis, “the calcinosis I get in my fingers, elbows, toes, and ears tops all the prior symptoms.” The skin tightening and digital ulcers that she experienced in the first 10 years have tapered off, and while Raynaud’s symptoms and heartburn have worsened, they are at least partly manageable with medications, unlike the pain from calcinosis.
 

Treating symptoms vs. disease may be key in risk-benefit analysis

In questions after patient presentations, FDA officials probed for more perspective on issues such as how fatigue should be assessed, the differences between fatigue and brain fog, the impact of calcinosis on functioning, and how much risk patients would be willing to assume from treatments that have side effects and that may or may not modulate the disease and slow disease progression.

Most patients said in response to an FDA poll question that they definitely (almost 40%) or possibly (almost 50%) would be willing to try a hypothetical new self-injectable medication if it were shown to reduce their most impactful symptoms but had side effects.

“I think what [we’ve been hearing] today is that whether we’re working on the symptoms or the disease itself is [the key]” to patients’ risk-benefit analysis, said meeting moderator Capt. Robyn Bent, RN, MS, of the U.S. Public Health Service, and director of the PFDD.

Anita Devine, diagnosed 13 years ago with systemic sclerosis, was one of several panel members who said she would accept more bothersome treatment side effects and risks “if the gain was control of disease progression and overall quality of life ... and organ preservation.” Ms. Devine, who has needed kidney dialysis and multiple hand surgeries, noted that she previously took anti-neoplastic and anti-inflammatory agents “to try to stem the course of my disease, but unfortunately the disease did not abate.”

Treatments for systemic sclerosis include vasodilators, immunosuppressive medications, antifibrotic therapies, and stem cell transplants, Dr. Khanna said in his opening remarks.

Trials of drugs for scleroderma have focused on early disease that may be amenable to treatment, with the exception of trials for pulmonary arterial hypertension, which affects some patients with systemic sclerosis. There are multiple FDA-approved drugs for pulmonary arterial hypertension and more trials are underway.

Outcomes such as pain and fatigue are included in many of the trials currently underway, but they tend to be lower-level secondary outcomes measures that cannot be incorporated into drug labeling or are more “exploratory in nature,” Dr. Khanna said in the interview.

Dr. Khanna disclosed that he is the chief medical officer (an equity position) for CiVi Biopharma/Eicos Sciences Inc., which is developing a drug for Raynaud’s, and serves as a consultant and grant recipient for numerous companies that make or are developing drugs for systemic sclerosis.

The FDA will accept patient comments until Dec. 15, 2020, at which time comments will be compiled into a summary report, Ms. Bent said.

Patients with systemic sclerosis have variable disease progression but often experience debilitating fatigue, pain, and digestive issues – and they’re extremely concerned about progressive organ damage, according to those who spoke at and provided input at a public meeting on patient-focused drug development for the disease.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The virtual meeting was part of the Food and Drug Administration’s Patient-Focused Drug Development (PFDD) initiative, which began in 2012 and aims to provide a systematic way for patients’ experiences, needs, and priorities to be “captured and meaningfully incorporated” into drug development and evaluation.
 

Patients rate their most impactful symptoms

Dinesh Khanna, MBBS, MSc, a rheumatologist who directs a scleroderma research program at the University of Michigan, Ann Arbor, attended the meeting after giving an opening presentation on the disease to FDA officials, patients, and other participants. In a later interview, he said that patients’ ratings of their most impactful symptoms was especially striking.

Raynaud’s phenomenon, digestive symptoms, and fatigue were the top three answers to a poll question that asked patients what symptom had the most significant impact on daily life, he noted, “and none of these are being [strongly] addressed right now [in clinical trials] apart from Raynaud’s phenomenon, for which there are some trials ongoing.”

He and other researchers are “struggling with what outcomes measures to use [in their studies],” said Dr. Khanna, the Frederick G.L. Huetwell Professor of Rheumatology at the University. “My takeaway from the meeting as a clinical trialist is that we should be paying close attention to the symptoms that patients tell us are the most important. We should be including these in our trial designs as secondary endpoints, if not primary endpoints. We have not done that [thus far], really.”

Approximately 200,000 patients in the United States have scleroderma, and approximately 75,000-80,000 of these patients have systemic scleroderma, or systemic sclerosis, Dr. Khanna said in his opening presentation. Each year, he estimates, about 6,000 new diagnoses of systemic sclerosis are made.

More than 200 people – patients, FDA officials, and others – participated in the PFDD meeting. Patients participated in one of two panels – one focused on health effects and daily impacts, and the other on treatments – or submitted input electronically. All were invited to answer poll questions.

Raj Nair, MD, one of eight FDA leaders attending the meeting, noted in closing remarks that the pain experienced by patients with systemic sclerosis includes severe pain from Raynaud’s phenomenon and pain caused by digital ulcers and by calcinosis. “We heard about how paralyzing the pain from calcinosis is, and that there are very few options for alleviating this pain,” said Dr. Nair, of the division of rheumatology and transplant medicine.

Another takeaway, he said, is that the “fatigue can be severe and debilitating, leading to days where it is impossible to get out of bed,” and that digestive symptoms can also be severe. “Reflux,” he noted, “requires significant medical intervention.”
 

Patients describe their experiences

Rosemary Lyons, diagnosed with scleroderma 35 years ago, explained that while her skin is no longer hardened, she is overly sensitive to fabrics and skin care products and has difficulty with sleeping and eating. She moved away from family in the Northeast to live in the South where the climate is warmer, but even on a 90-degree night she needs a blanket and two comforters to curb the cold and attempt to sleep.

Impaired gastrointestinal motility has made food her “biggest problem” for the past 10 years, and because of GI symptoms, she can eat only one meal a day. She also experiences fainting, brain fog, and severe fatigue. On a good day, Ms. Lyons noted, she sometimes opts to do some house chores “knowing that I’ll have 1-3 days of recovery.”

Another patient, Amy Harding, said that 22 years after her scleroderma diagnosis, “the calcinosis I get in my fingers, elbows, toes, and ears tops all the prior symptoms.” The skin tightening and digital ulcers that she experienced in the first 10 years have tapered off, and while Raynaud’s symptoms and heartburn have worsened, they are at least partly manageable with medications, unlike the pain from calcinosis.
 

Treating symptoms vs. disease may be key in risk-benefit analysis

In questions after patient presentations, FDA officials probed for more perspective on issues such as how fatigue should be assessed, the differences between fatigue and brain fog, the impact of calcinosis on functioning, and how much risk patients would be willing to assume from treatments that have side effects and that may or may not modulate the disease and slow disease progression.

Most patients said in response to an FDA poll question that they definitely (almost 40%) or possibly (almost 50%) would be willing to try a hypothetical new self-injectable medication if it were shown to reduce their most impactful symptoms but had side effects.

“I think what [we’ve been hearing] today is that whether we’re working on the symptoms or the disease itself is [the key]” to patients’ risk-benefit analysis, said meeting moderator Capt. Robyn Bent, RN, MS, of the U.S. Public Health Service, and director of the PFDD.

Anita Devine, diagnosed 13 years ago with systemic sclerosis, was one of several panel members who said she would accept more bothersome treatment side effects and risks “if the gain was control of disease progression and overall quality of life ... and organ preservation.” Ms. Devine, who has needed kidney dialysis and multiple hand surgeries, noted that she previously took anti-neoplastic and anti-inflammatory agents “to try to stem the course of my disease, but unfortunately the disease did not abate.”

Treatments for systemic sclerosis include vasodilators, immunosuppressive medications, antifibrotic therapies, and stem cell transplants, Dr. Khanna said in his opening remarks.

Trials of drugs for scleroderma have focused on early disease that may be amenable to treatment, with the exception of trials for pulmonary arterial hypertension, which affects some patients with systemic sclerosis. There are multiple FDA-approved drugs for pulmonary arterial hypertension and more trials are underway.

Outcomes such as pain and fatigue are included in many of the trials currently underway, but they tend to be lower-level secondary outcomes measures that cannot be incorporated into drug labeling or are more “exploratory in nature,” Dr. Khanna said in the interview.

Dr. Khanna disclosed that he is the chief medical officer (an equity position) for CiVi Biopharma/Eicos Sciences Inc., which is developing a drug for Raynaud’s, and serves as a consultant and grant recipient for numerous companies that make or are developing drugs for systemic sclerosis.

The FDA will accept patient comments until Dec. 15, 2020, at which time comments will be compiled into a summary report, Ms. Bent said.

Patients with B-cell lymphoma are immunocompromised because of the disease and its treatments. This presents the question of their outcomes upon infection with SARS-CoV-2. Researchers assessed the characteristics of patients with lymphoma hospitalized for COVID-19 and analyzed determinants of mortality in a retrospective database study. The investigators looked at data from adult patients with lymphoma who were hospitalized for COVID-19 in March and April 2020 in three French regions.

CoRus13/Wikimedia Commons/Creative Commons 4.0

Older age and relapsed/refractory (r/r) disease in B-cell lymphoma patients were both found to be independent risk factors of increased death rate from COVID-19, according to the online report in EClinicalMedicine, published by The Lancet.

These results encourage “the application of standard Covid-19 treatment, including intubation, for lymphoma patients with Covid-19 lymphoma diagnosis, under first- or second-line chemotherapy, or in remission,” according to Sylvain Lamure, MD, of Montellier (France) University, and colleagues.

The study examined a series of 89 consecutive patients from three French regions who had lymphoma and were hospitalized for COVID-19 in March and April 2020. The population was homogeneous; most patients were diagnosed with B-cell non-Hodgkin lymphoma (NHL) and had been treated for their lymphoma within 1 year.
 

Promising results for many

There were a significant associations between 30-day mortality and increasing age (over age 70 years) and r/r lymphoma. However, in the absence of those factors, mortality of the lymphoma patients with COVID-19 was comparable with that of the reference French COVID-19 population. In addition, there was no significant impact of active lymphoma treatment that had been given within 1 year, except for those patients who received bendamustine, which was associated with greater mortality, according to the researchers.

With a median follow-up of 33 days from admission, the Kaplan-Meier estimate of 30-day overall survival was 71% (95% confidence interval, 62%-81%). According to histological type of the lymphoma, 30-day overall survival rates were 80% (95% CI, 45%-100%) for Hodgkin lymphoma, 71% (95% CI, 61%-82%) for B-cell non-Hodgkin Lymphoma, and 71% (95% CI, 38%-100%) for T-cell non-Hodgkin Lymphoma.

The main factors associated with mortality were age 70 years and older (hazard ratio, 3.78; 95% CI, 1.73-8.25; P = .0009), hypertension (HR, 2.20; 95% CI, 1.06-4.59; P = .03), previous cancer (HR, 2.11; 95% CI, 0.90-4.92; P = .08), use of bendamustine within 12 months before admission to hospital (HR, 3.05; 95% CI, 1.31-7.11; P = .01), and r/r lymphoma (HR, 2.62; 95% CI, 1.20-5.72; P = .02).

Overall, the Kaplan-Meier estimates of 30-day overall survival were 61% for patients with r/r lymphoma, 52% in patients age 70 years with non–r/r lymphoma, and 88% for patients younger than 70 years with non–r/r, which was comparable with general population survival data among French populations, according to the researchers.

“Longer term clinical follow-up and biological monitoring of immune responses is warranted to explore the impact of lymphoma and its treatment on the immunity and prolonged outcome of Covid-19 patients,” they concluded.

The study was unsponsored. Several of the authors reported financial relationships with a number of biotechnology and pharmaceutical companies.

[email protected]

SOURCE: Lamure S et al. EClinicalMedicine. 2020 Oct 12. doi: 10.1016/j.eclinm.2020.100549.

Patients with B-cell lymphoma are immunocompromised because of the disease and its treatments. This presents the question of their outcomes upon infection with SARS-CoV-2. Researchers assessed the characteristics of patients with lymphoma hospitalized for COVID-19 and analyzed determinants of mortality in a retrospective database study. The investigators looked at data from adult patients with lymphoma who were hospitalized for COVID-19 in March and April 2020 in three French regions.

CoRus13/Wikimedia Commons/Creative Commons 4.0

Older age and relapsed/refractory (r/r) disease in B-cell lymphoma patients were both found to be independent risk factors of increased death rate from COVID-19, according to the online report in EClinicalMedicine, published by The Lancet.

These results encourage “the application of standard Covid-19 treatment, including intubation, for lymphoma patients with Covid-19 lymphoma diagnosis, under first- or second-line chemotherapy, or in remission,” according to Sylvain Lamure, MD, of Montellier (France) University, and colleagues.

The study examined a series of 89 consecutive patients from three French regions who had lymphoma and were hospitalized for COVID-19 in March and April 2020. The population was homogeneous; most patients were diagnosed with B-cell non-Hodgkin lymphoma (NHL) and had been treated for their lymphoma within 1 year.
 

Promising results for many

There were a significant associations between 30-day mortality and increasing age (over age 70 years) and r/r lymphoma. However, in the absence of those factors, mortality of the lymphoma patients with COVID-19 was comparable with that of the reference French COVID-19 population. In addition, there was no significant impact of active lymphoma treatment that had been given within 1 year, except for those patients who received bendamustine, which was associated with greater mortality, according to the researchers.

With a median follow-up of 33 days from admission, the Kaplan-Meier estimate of 30-day overall survival was 71% (95% confidence interval, 62%-81%). According to histological type of the lymphoma, 30-day overall survival rates were 80% (95% CI, 45%-100%) for Hodgkin lymphoma, 71% (95% CI, 61%-82%) for B-cell non-Hodgkin Lymphoma, and 71% (95% CI, 38%-100%) for T-cell non-Hodgkin Lymphoma.

The main factors associated with mortality were age 70 years and older (hazard ratio, 3.78; 95% CI, 1.73-8.25; P = .0009), hypertension (HR, 2.20; 95% CI, 1.06-4.59; P = .03), previous cancer (HR, 2.11; 95% CI, 0.90-4.92; P = .08), use of bendamustine within 12 months before admission to hospital (HR, 3.05; 95% CI, 1.31-7.11; P = .01), and r/r lymphoma (HR, 2.62; 95% CI, 1.20-5.72; P = .02).

Overall, the Kaplan-Meier estimates of 30-day overall survival were 61% for patients with r/r lymphoma, 52% in patients age 70 years with non–r/r lymphoma, and 88% for patients younger than 70 years with non–r/r, which was comparable with general population survival data among French populations, according to the researchers.

“Longer term clinical follow-up and biological monitoring of immune responses is warranted to explore the impact of lymphoma and its treatment on the immunity and prolonged outcome of Covid-19 patients,” they concluded.

The study was unsponsored. Several of the authors reported financial relationships with a number of biotechnology and pharmaceutical companies.

[email protected]

SOURCE: Lamure S et al. EClinicalMedicine. 2020 Oct 12. doi: 10.1016/j.eclinm.2020.100549.

Patients with B-cell lymphoma are immunocompromised because of the disease and its treatments. This presents the question of their outcomes upon infection with SARS-CoV-2. Researchers assessed the characteristics of patients with lymphoma hospitalized for COVID-19 and analyzed determinants of mortality in a retrospective database study. The investigators looked at data from adult patients with lymphoma who were hospitalized for COVID-19 in March and April 2020 in three French regions.

CoRus13/Wikimedia Commons/Creative Commons 4.0

Older age and relapsed/refractory (r/r) disease in B-cell lymphoma patients were both found to be independent risk factors of increased death rate from COVID-19, according to the online report in EClinicalMedicine, published by The Lancet.

These results encourage “the application of standard Covid-19 treatment, including intubation, for lymphoma patients with Covid-19 lymphoma diagnosis, under first- or second-line chemotherapy, or in remission,” according to Sylvain Lamure, MD, of Montellier (France) University, and colleagues.

The study examined a series of 89 consecutive patients from three French regions who had lymphoma and were hospitalized for COVID-19 in March and April 2020. The population was homogeneous; most patients were diagnosed with B-cell non-Hodgkin lymphoma (NHL) and had been treated for their lymphoma within 1 year.
 

Promising results for many

There were a significant associations between 30-day mortality and increasing age (over age 70 years) and r/r lymphoma. However, in the absence of those factors, mortality of the lymphoma patients with COVID-19 was comparable with that of the reference French COVID-19 population. In addition, there was no significant impact of active lymphoma treatment that had been given within 1 year, except for those patients who received bendamustine, which was associated with greater mortality, according to the researchers.

With a median follow-up of 33 days from admission, the Kaplan-Meier estimate of 30-day overall survival was 71% (95% confidence interval, 62%-81%). According to histological type of the lymphoma, 30-day overall survival rates were 80% (95% CI, 45%-100%) for Hodgkin lymphoma, 71% (95% CI, 61%-82%) for B-cell non-Hodgkin Lymphoma, and 71% (95% CI, 38%-100%) for T-cell non-Hodgkin Lymphoma.

The main factors associated with mortality were age 70 years and older (hazard ratio, 3.78; 95% CI, 1.73-8.25; P = .0009), hypertension (HR, 2.20; 95% CI, 1.06-4.59; P = .03), previous cancer (HR, 2.11; 95% CI, 0.90-4.92; P = .08), use of bendamustine within 12 months before admission to hospital (HR, 3.05; 95% CI, 1.31-7.11; P = .01), and r/r lymphoma (HR, 2.62; 95% CI, 1.20-5.72; P = .02).

Overall, the Kaplan-Meier estimates of 30-day overall survival were 61% for patients with r/r lymphoma, 52% in patients age 70 years with non–r/r lymphoma, and 88% for patients younger than 70 years with non–r/r, which was comparable with general population survival data among French populations, according to the researchers.

“Longer term clinical follow-up and biological monitoring of immune responses is warranted to explore the impact of lymphoma and its treatment on the immunity and prolonged outcome of Covid-19 patients,” they concluded.

The study was unsponsored. Several of the authors reported financial relationships with a number of biotechnology and pharmaceutical companies.

[email protected]

SOURCE: Lamure S et al. EClinicalMedicine. 2020 Oct 12. doi: 10.1016/j.eclinm.2020.100549.

Non-White patient participation in phase 3 therapeutic trials for plaque psoriasis is less than 15%, according to a recently published analysis of data from the ClinicalTrials.gov database.

The exact figure drawn from the survey of 82 trials was 14.2%, but 20 (24%) of the trials did not include ethnoracial data at all, and only 65% of those with data had complete data, according to a report in the British Journal of Dermatology by a team of investigators from the department of dermatology at the University of California, San Francisco.

“The remaining studies reported the percentage of white participants only or white participants and one additional ethnoracial group,” reported the investigators, led by Vidhatha D. Reddy, a medical student at UCSF.

The investigators broke down participation by race in all phase 3 plaque psoriasis trials that enrolled adults and had posted results by May 2020. Data from trials of medications yet to be approved were excluded.

Most trials were multinational. The medications evaluated included 11 biologics, 10 topicals, 2 oral systemic agents, and a phosphodiesterase type-4 inhibitor. The 82 trials included in this analysis enrolled 48,846 collectively.

From trials that identified race, 85.8% of 39,161 participants were White, 3.09% of 25,565 patients were Black, 19.55% of 11,364 patients were Hispanic or Latino, and 9.21% of 30,009 patients were Asian. Of trials that included Native Americans or Pacific Islanders, fewer than 2% of participants represented this category.

Non-White patients remain underrepresented even when recognizing differences in the prevalence of psoriasis. For example, one recent survey found the U.S, prevalence of psoriasis to be about half as great in Blacks as it is in Whites (1.9% vs. 3.9%), but the representation of Blacks in the phase 3 trials evaluated by Mr. Reddy and colleagues was more than 20 times lower.

There are many reasons to suspect that lack of diversification in psoriasis trials is impeding optimal care in those underrepresented. Of several examples offered by the authors, one involved differential responses to adalimumab among patients with hidradenitis suppurativa with genetic variants in the BCL2 gene, but the authors reported racially associated genetic differences are not uncommon.

“Estimates have shown that approximately one-fifth of newly developed medications demonstrate interracial/ethnic variability in regard to various factors, such as pharmacokinetics, safety and efficacy profiles, dosing, and pharmacogenetics,” Mr. Reddy and his coinvestigators stated.

Although racial diversity in the design and recruitment for clinical trials has not been a priority in trials involving psoriasis, other skin diseases, or most diseases in general, the authors cited some evidence that this is changing.

“Since 2017, research funded by the National Institutes of Health has been required to report race and ethnicity of participants following an amendment to the Health Revitalization Act,” according to the authors, who suggested that other such initiatives are needed. They advocated “explicit goals to increase recruitment of people of color” as a standard step in clinical trial conduct.

Hypertension trials were cited as an example in which diversity has made a difference.

“Although Black patients are at an elevated risk of developing hypertension, it was not until the enrollment of a substantial proportion of black participants in ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) that enough data on Black patients were available to make specific treatment recommendations in this population,” they noted.
 

Impossible to know treatment benefits without ethnoracial data

Penn Medicine

Another investigator who has considered this issue, Junko Takeshita, MD, PhD, an assistant professor of dermatology at the University of Pennsylvania, Philadelphia, agreed.

“Lack of diversity among participants in phase 3 clinical trials for psoriasis is a problem,” said Dr. Takeshita, who led a study of racial differences in perceptions of psoriasis therapies that was published last year.

In that study, “my research group not only found differences in perceptions about biologics between Black and White patients with psoriasis, but we have also shown that Black patients with psoriasis are less likely to receive biologic treatment,” she reported. There are many explanations. For example, she found in another study that Black patients are underrepresented in direct-to-consumer advertisements for biologics.

This problem is not unique to psoriasis. Underrepresentation of Blacks and other ethnoracial groups is true of other skin diseases and many diseases in general, according to Dr. Takeshita. However, she cautioned that the 3% figure for Black participation in psoriasis trials reported by Mr. Reddy and colleagues is not necessarily reflective of trials in the United States.

“This study included international study sites that are recruiting patients from populations with different demographics than the U.S.,” she noted. By including sites with only Asian patients or countries with few Blacks in the population, it dilutes Black representation. She would expect the exact proportion of Black participants to be somewhat higher even if they are “still likely to be underrepresented” if the analysis has been limited to U.S. data.

The research had no funding source. Three of the nine authors reported financial relationships with pharmaceutical companies.

SOURCE: Reddy VD et al. Br J Dermatol. 2020 Sep 17. doi: 10.1111/bjd.19468.

Non-White patient participation in phase 3 therapeutic trials for plaque psoriasis is less than 15%, according to a recently published analysis of data from the ClinicalTrials.gov database.

The exact figure drawn from the survey of 82 trials was 14.2%, but 20 (24%) of the trials did not include ethnoracial data at all, and only 65% of those with data had complete data, according to a report in the British Journal of Dermatology by a team of investigators from the department of dermatology at the University of California, San Francisco.

“The remaining studies reported the percentage of white participants only or white participants and one additional ethnoracial group,” reported the investigators, led by Vidhatha D. Reddy, a medical student at UCSF.

The investigators broke down participation by race in all phase 3 plaque psoriasis trials that enrolled adults and had posted results by May 2020. Data from trials of medications yet to be approved were excluded.

Most trials were multinational. The medications evaluated included 11 biologics, 10 topicals, 2 oral systemic agents, and a phosphodiesterase type-4 inhibitor. The 82 trials included in this analysis enrolled 48,846 collectively.

From trials that identified race, 85.8% of 39,161 participants were White, 3.09% of 25,565 patients were Black, 19.55% of 11,364 patients were Hispanic or Latino, and 9.21% of 30,009 patients were Asian. Of trials that included Native Americans or Pacific Islanders, fewer than 2% of participants represented this category.

Non-White patients remain underrepresented even when recognizing differences in the prevalence of psoriasis. For example, one recent survey found the U.S, prevalence of psoriasis to be about half as great in Blacks as it is in Whites (1.9% vs. 3.9%), but the representation of Blacks in the phase 3 trials evaluated by Mr. Reddy and colleagues was more than 20 times lower.

There are many reasons to suspect that lack of diversification in psoriasis trials is impeding optimal care in those underrepresented. Of several examples offered by the authors, one involved differential responses to adalimumab among patients with hidradenitis suppurativa with genetic variants in the BCL2 gene, but the authors reported racially associated genetic differences are not uncommon.

“Estimates have shown that approximately one-fifth of newly developed medications demonstrate interracial/ethnic variability in regard to various factors, such as pharmacokinetics, safety and efficacy profiles, dosing, and pharmacogenetics,” Mr. Reddy and his coinvestigators stated.

Although racial diversity in the design and recruitment for clinical trials has not been a priority in trials involving psoriasis, other skin diseases, or most diseases in general, the authors cited some evidence that this is changing.

“Since 2017, research funded by the National Institutes of Health has been required to report race and ethnicity of participants following an amendment to the Health Revitalization Act,” according to the authors, who suggested that other such initiatives are needed. They advocated “explicit goals to increase recruitment of people of color” as a standard step in clinical trial conduct.

Hypertension trials were cited as an example in which diversity has made a difference.

“Although Black patients are at an elevated risk of developing hypertension, it was not until the enrollment of a substantial proportion of black participants in ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) that enough data on Black patients were available to make specific treatment recommendations in this population,” they noted.
 

Impossible to know treatment benefits without ethnoracial data

Penn Medicine

Another investigator who has considered this issue, Junko Takeshita, MD, PhD, an assistant professor of dermatology at the University of Pennsylvania, Philadelphia, agreed.

“Lack of diversity among participants in phase 3 clinical trials for psoriasis is a problem,” said Dr. Takeshita, who led a study of racial differences in perceptions of psoriasis therapies that was published last year.

In that study, “my research group not only found differences in perceptions about biologics between Black and White patients with psoriasis, but we have also shown that Black patients with psoriasis are less likely to receive biologic treatment,” she reported. There are many explanations. For example, she found in another study that Black patients are underrepresented in direct-to-consumer advertisements for biologics.

This problem is not unique to psoriasis. Underrepresentation of Blacks and other ethnoracial groups is true of other skin diseases and many diseases in general, according to Dr. Takeshita. However, she cautioned that the 3% figure for Black participation in psoriasis trials reported by Mr. Reddy and colleagues is not necessarily reflective of trials in the United States.

“This study included international study sites that are recruiting patients from populations with different demographics than the U.S.,” she noted. By including sites with only Asian patients or countries with few Blacks in the population, it dilutes Black representation. She would expect the exact proportion of Black participants to be somewhat higher even if they are “still likely to be underrepresented” if the analysis has been limited to U.S. data.

The research had no funding source. Three of the nine authors reported financial relationships with pharmaceutical companies.

SOURCE: Reddy VD et al. Br J Dermatol. 2020 Sep 17. doi: 10.1111/bjd.19468.

Non-White patient participation in phase 3 therapeutic trials for plaque psoriasis is less than 15%, according to a recently published analysis of data from the ClinicalTrials.gov database.

The exact figure drawn from the survey of 82 trials was 14.2%, but 20 (24%) of the trials did not include ethnoracial data at all, and only 65% of those with data had complete data, according to a report in the British Journal of Dermatology by a team of investigators from the department of dermatology at the University of California, San Francisco.

“The remaining studies reported the percentage of white participants only or white participants and one additional ethnoracial group,” reported the investigators, led by Vidhatha D. Reddy, a medical student at UCSF.

The investigators broke down participation by race in all phase 3 plaque psoriasis trials that enrolled adults and had posted results by May 2020. Data from trials of medications yet to be approved were excluded.

Most trials were multinational. The medications evaluated included 11 biologics, 10 topicals, 2 oral systemic agents, and a phosphodiesterase type-4 inhibitor. The 82 trials included in this analysis enrolled 48,846 collectively.

From trials that identified race, 85.8% of 39,161 participants were White, 3.09% of 25,565 patients were Black, 19.55% of 11,364 patients were Hispanic or Latino, and 9.21% of 30,009 patients were Asian. Of trials that included Native Americans or Pacific Islanders, fewer than 2% of participants represented this category.

Non-White patients remain underrepresented even when recognizing differences in the prevalence of psoriasis. For example, one recent survey found the U.S, prevalence of psoriasis to be about half as great in Blacks as it is in Whites (1.9% vs. 3.9%), but the representation of Blacks in the phase 3 trials evaluated by Mr. Reddy and colleagues was more than 20 times lower.

There are many reasons to suspect that lack of diversification in psoriasis trials is impeding optimal care in those underrepresented. Of several examples offered by the authors, one involved differential responses to adalimumab among patients with hidradenitis suppurativa with genetic variants in the BCL2 gene, but the authors reported racially associated genetic differences are not uncommon.

“Estimates have shown that approximately one-fifth of newly developed medications demonstrate interracial/ethnic variability in regard to various factors, such as pharmacokinetics, safety and efficacy profiles, dosing, and pharmacogenetics,” Mr. Reddy and his coinvestigators stated.

Although racial diversity in the design and recruitment for clinical trials has not been a priority in trials involving psoriasis, other skin diseases, or most diseases in general, the authors cited some evidence that this is changing.

“Since 2017, research funded by the National Institutes of Health has been required to report race and ethnicity of participants following an amendment to the Health Revitalization Act,” according to the authors, who suggested that other such initiatives are needed. They advocated “explicit goals to increase recruitment of people of color” as a standard step in clinical trial conduct.

Hypertension trials were cited as an example in which diversity has made a difference.

“Although Black patients are at an elevated risk of developing hypertension, it was not until the enrollment of a substantial proportion of black participants in ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial) that enough data on Black patients were available to make specific treatment recommendations in this population,” they noted.
 

Impossible to know treatment benefits without ethnoracial data

Penn Medicine

Another investigator who has considered this issue, Junko Takeshita, MD, PhD, an assistant professor of dermatology at the University of Pennsylvania, Philadelphia, agreed.

“Lack of diversity among participants in phase 3 clinical trials for psoriasis is a problem,” said Dr. Takeshita, who led a study of racial differences in perceptions of psoriasis therapies that was published last year.

In that study, “my research group not only found differences in perceptions about biologics between Black and White patients with psoriasis, but we have also shown that Black patients with psoriasis are less likely to receive biologic treatment,” she reported. There are many explanations. For example, she found in another study that Black patients are underrepresented in direct-to-consumer advertisements for biologics.

This problem is not unique to psoriasis. Underrepresentation of Blacks and other ethnoracial groups is true of other skin diseases and many diseases in general, according to Dr. Takeshita. However, she cautioned that the 3% figure for Black participation in psoriasis trials reported by Mr. Reddy and colleagues is not necessarily reflective of trials in the United States.

“This study included international study sites that are recruiting patients from populations with different demographics than the U.S.,” she noted. By including sites with only Asian patients or countries with few Blacks in the population, it dilutes Black representation. She would expect the exact proportion of Black participants to be somewhat higher even if they are “still likely to be underrepresented” if the analysis has been limited to U.S. data.

The research had no funding source. Three of the nine authors reported financial relationships with pharmaceutical companies.

SOURCE: Reddy VD et al. Br J Dermatol. 2020 Sep 17. doi: 10.1111/bjd.19468.

We can “stop putting money on vitamin D” to help patients who require critical care, said Todd Rice, MD, FCCP.

“Results from vitamin D trials have not been uniformly one way, but they have been pretty uniformly disappointing,” Dr. Rice, from Vanderbilt University Medical Center, Nashville, Tenn., reported at the annual meeting of the American College of Chest Physicians.

Low levels of vitamin D in critically ill COVID-19 patients have been reported in numerous recent studies, and researchers are looking for ways to boost those levels and improve outcomes.

We are seeing “the exact same story” in the critically ill COVID-19 population as we see in the general ICU population, said Dr. Rice. “The whole scenario is repeating itself. I’m pessimistic.”

Still, vitamin D levels can be elevated so, in theory, “the concept makes sense,” he said. There is evidence that, “when given enterally, the levels rise nicely” and vitamin D is absorbed reasonably well.” But is that enough?

When patients are admitted to the ICU, some biomarkers in the body are too high and others are too low. Vitamin D is often too low. So far, though, “supplementing vitamin D in the ICU has not significantly improved outcomes,” said Dr. Rice.

In the Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET) trial, Dr. Rice and colleagues found no statistical benefit when a 540,000 IU boost of vitamin D was administered to 2,624 critically ill patients, as reported by Medscape Medical News.

“Early administration of high-dose enteral vitamin D₃ did not provide an advantage over placebo with respect to 90-day mortality or other nonfatal outcomes among critically ill, vitamin D–deficient patients,” the researchers write in their recent report.

In fact, VIOLET ended before enrollment had reached the planned 3,000-patient cohort because the statistical analysis clearly did not show benefit. Those enrolled were in the ICU because of, among other things, pneumonia, sepsis, the need for mechanical ventilation or vasopressors, and risk for acute respiratory distress syndrome.

“It doesn’t look like vitamin D is going to be the answer to our critical care problems,” Dr. Rice said in an interview.
 

Maintenance dose needed?

One theory suggests that VIOLET might have failed because a maintenance dose is needed after the initial boost of vitamin D.

In the ongoing VITDALIZE trial, critically ill patients with severe vitamin D deficiency (12 ng/mL or less at admission) receive an initial 540,000-IU dose followed by 4,000 IU per day.

The highly anticipated VITDALIZE results are expected in the middle of next year, Dr. Rice reported, so “let’s wait to see.”

“Vitamin D may not have an acute effect,” he theorized. “We can raise your levels, but that doesn’t give you all the benefits of having a sufficient level for a long period of time.”

Another theory suggests that a low level of vitamin D is simply a signal of the severity of disease, not a direct influence on disease pathology.

Some observational data have shown an association between low levels of vitamin D and outcomes in COVID-19 patients (Nutrients. 2020 May 9;12[5]:1359; medRxiv 2020 Apr 24. doi: 10.1101/2020.04.24.20075838; JAMA Netw Open. 2020;3[9]:e2019722; FEBS J. 2020 Jul 23;10.1111/febs.15495; Clin Endocrinol [Oxf]. 2020 Jul 3;10.1111/cen.14276), but some have shown no association (medRxiv. 2020 Jun 26. doi: 10.1101/2020.06.26.20140921; J Public Health [Oxf]. 2020 Aug 18;42[3]:451-60).

Dr. Rice conducted a search of Clinicaltrials.gov immediately before his presentation on Sunday, and found 41 ongoing interventional studies – “not observational studies” – looking at COVID-19 and vitamin D.

“They’re recruiting, they’re enrolling; hopefully we’ll have data soon,” he said.

Researchers have checked a lot of boxes with a resounding yes on the vitamin D question, so there’s reason to think an association does exist for ICU patients, whether or not they have COVID-19.

“Is there a theoretical benefit of vitamin D in the ICU?” Dr. Rice asked. “Yes. Is vitamin D deficient in patients in the ICU? Yes. Is that deficiency associated with poor outcomes? Yes. Can it be replaced safely? Yes.”

However, “we’re not really sure that it improves outcomes,” he said.
 

A chronic issue?

“Do you think it’s really an issue of the patients being critically ill with vitamin D,” or is it “a chronic issue of having low vitamin D?” asked session moderator Antine Stenbit, MD, PhD, from the University of California, San Diego.

“We don’t know for sure,” Dr. Rice said. Vitamin D might not have a lot of acute effects; it might have effects that are chronic, that work with levels over a period of time, he explained.

“It’s not clear we can correct that with a single dose or with a few days of giving a level that is adequate,” he acknowledged.

Dr. Rice is an investigator in the PETAL network. Dr. Stenbit disclosed no relevant financial relationships.

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

We can “stop putting money on vitamin D” to help patients who require critical care, said Todd Rice, MD, FCCP.

“Results from vitamin D trials have not been uniformly one way, but they have been pretty uniformly disappointing,” Dr. Rice, from Vanderbilt University Medical Center, Nashville, Tenn., reported at the annual meeting of the American College of Chest Physicians.

Low levels of vitamin D in critically ill COVID-19 patients have been reported in numerous recent studies, and researchers are looking for ways to boost those levels and improve outcomes.

We are seeing “the exact same story” in the critically ill COVID-19 population as we see in the general ICU population, said Dr. Rice. “The whole scenario is repeating itself. I’m pessimistic.”

Still, vitamin D levels can be elevated so, in theory, “the concept makes sense,” he said. There is evidence that, “when given enterally, the levels rise nicely” and vitamin D is absorbed reasonably well.” But is that enough?

When patients are admitted to the ICU, some biomarkers in the body are too high and others are too low. Vitamin D is often too low. So far, though, “supplementing vitamin D in the ICU has not significantly improved outcomes,” said Dr. Rice.

In the Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET) trial, Dr. Rice and colleagues found no statistical benefit when a 540,000 IU boost of vitamin D was administered to 2,624 critically ill patients, as reported by Medscape Medical News.

“Early administration of high-dose enteral vitamin D₃ did not provide an advantage over placebo with respect to 90-day mortality or other nonfatal outcomes among critically ill, vitamin D–deficient patients,” the researchers write in their recent report.

In fact, VIOLET ended before enrollment had reached the planned 3,000-patient cohort because the statistical analysis clearly did not show benefit. Those enrolled were in the ICU because of, among other things, pneumonia, sepsis, the need for mechanical ventilation or vasopressors, and risk for acute respiratory distress syndrome.

“It doesn’t look like vitamin D is going to be the answer to our critical care problems,” Dr. Rice said in an interview.
 

Maintenance dose needed?

One theory suggests that VIOLET might have failed because a maintenance dose is needed after the initial boost of vitamin D.

In the ongoing VITDALIZE trial, critically ill patients with severe vitamin D deficiency (12 ng/mL or less at admission) receive an initial 540,000-IU dose followed by 4,000 IU per day.

The highly anticipated VITDALIZE results are expected in the middle of next year, Dr. Rice reported, so “let’s wait to see.”

“Vitamin D may not have an acute effect,” he theorized. “We can raise your levels, but that doesn’t give you all the benefits of having a sufficient level for a long period of time.”

Another theory suggests that a low level of vitamin D is simply a signal of the severity of disease, not a direct influence on disease pathology.

Some observational data have shown an association between low levels of vitamin D and outcomes in COVID-19 patients (Nutrients. 2020 May 9;12[5]:1359; medRxiv 2020 Apr 24. doi: 10.1101/2020.04.24.20075838; JAMA Netw Open. 2020;3[9]:e2019722; FEBS J. 2020 Jul 23;10.1111/febs.15495; Clin Endocrinol [Oxf]. 2020 Jul 3;10.1111/cen.14276), but some have shown no association (medRxiv. 2020 Jun 26. doi: 10.1101/2020.06.26.20140921; J Public Health [Oxf]. 2020 Aug 18;42[3]:451-60).

Dr. Rice conducted a search of Clinicaltrials.gov immediately before his presentation on Sunday, and found 41 ongoing interventional studies – “not observational studies” – looking at COVID-19 and vitamin D.

“They’re recruiting, they’re enrolling; hopefully we’ll have data soon,” he said.

Researchers have checked a lot of boxes with a resounding yes on the vitamin D question, so there’s reason to think an association does exist for ICU patients, whether or not they have COVID-19.

“Is there a theoretical benefit of vitamin D in the ICU?” Dr. Rice asked. “Yes. Is vitamin D deficient in patients in the ICU? Yes. Is that deficiency associated with poor outcomes? Yes. Can it be replaced safely? Yes.”

However, “we’re not really sure that it improves outcomes,” he said.
 

A chronic issue?

“Do you think it’s really an issue of the patients being critically ill with vitamin D,” or is it “a chronic issue of having low vitamin D?” asked session moderator Antine Stenbit, MD, PhD, from the University of California, San Diego.

“We don’t know for sure,” Dr. Rice said. Vitamin D might not have a lot of acute effects; it might have effects that are chronic, that work with levels over a period of time, he explained.

“It’s not clear we can correct that with a single dose or with a few days of giving a level that is adequate,” he acknowledged.

Dr. Rice is an investigator in the PETAL network. Dr. Stenbit disclosed no relevant financial relationships.

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

We can “stop putting money on vitamin D” to help patients who require critical care, said Todd Rice, MD, FCCP.

“Results from vitamin D trials have not been uniformly one way, but they have been pretty uniformly disappointing,” Dr. Rice, from Vanderbilt University Medical Center, Nashville, Tenn., reported at the annual meeting of the American College of Chest Physicians.

Low levels of vitamin D in critically ill COVID-19 patients have been reported in numerous recent studies, and researchers are looking for ways to boost those levels and improve outcomes.

We are seeing “the exact same story” in the critically ill COVID-19 population as we see in the general ICU population, said Dr. Rice. “The whole scenario is repeating itself. I’m pessimistic.”

Still, vitamin D levels can be elevated so, in theory, “the concept makes sense,” he said. There is evidence that, “when given enterally, the levels rise nicely” and vitamin D is absorbed reasonably well.” But is that enough?

When patients are admitted to the ICU, some biomarkers in the body are too high and others are too low. Vitamin D is often too low. So far, though, “supplementing vitamin D in the ICU has not significantly improved outcomes,” said Dr. Rice.

In the Vitamin D to Improve Outcomes by Leveraging Early Treatment (VIOLET) trial, Dr. Rice and colleagues found no statistical benefit when a 540,000 IU boost of vitamin D was administered to 2,624 critically ill patients, as reported by Medscape Medical News.

“Early administration of high-dose enteral vitamin D₃ did not provide an advantage over placebo with respect to 90-day mortality or other nonfatal outcomes among critically ill, vitamin D–deficient patients,” the researchers write in their recent report.

In fact, VIOLET ended before enrollment had reached the planned 3,000-patient cohort because the statistical analysis clearly did not show benefit. Those enrolled were in the ICU because of, among other things, pneumonia, sepsis, the need for mechanical ventilation or vasopressors, and risk for acute respiratory distress syndrome.

“It doesn’t look like vitamin D is going to be the answer to our critical care problems,” Dr. Rice said in an interview.
 

Maintenance dose needed?

One theory suggests that VIOLET might have failed because a maintenance dose is needed after the initial boost of vitamin D.

In the ongoing VITDALIZE trial, critically ill patients with severe vitamin D deficiency (12 ng/mL or less at admission) receive an initial 540,000-IU dose followed by 4,000 IU per day.

The highly anticipated VITDALIZE results are expected in the middle of next year, Dr. Rice reported, so “let’s wait to see.”

“Vitamin D may not have an acute effect,” he theorized. “We can raise your levels, but that doesn’t give you all the benefits of having a sufficient level for a long period of time.”

Another theory suggests that a low level of vitamin D is simply a signal of the severity of disease, not a direct influence on disease pathology.

Some observational data have shown an association between low levels of vitamin D and outcomes in COVID-19 patients (Nutrients. 2020 May 9;12[5]:1359; medRxiv 2020 Apr 24. doi: 10.1101/2020.04.24.20075838; JAMA Netw Open. 2020;3[9]:e2019722; FEBS J. 2020 Jul 23;10.1111/febs.15495; Clin Endocrinol [Oxf]. 2020 Jul 3;10.1111/cen.14276), but some have shown no association (medRxiv. 2020 Jun 26. doi: 10.1101/2020.06.26.20140921; J Public Health [Oxf]. 2020 Aug 18;42[3]:451-60).

Dr. Rice conducted a search of Clinicaltrials.gov immediately before his presentation on Sunday, and found 41 ongoing interventional studies – “not observational studies” – looking at COVID-19 and vitamin D.

“They’re recruiting, they’re enrolling; hopefully we’ll have data soon,” he said.

Researchers have checked a lot of boxes with a resounding yes on the vitamin D question, so there’s reason to think an association does exist for ICU patients, whether or not they have COVID-19.

“Is there a theoretical benefit of vitamin D in the ICU?” Dr. Rice asked. “Yes. Is vitamin D deficient in patients in the ICU? Yes. Is that deficiency associated with poor outcomes? Yes. Can it be replaced safely? Yes.”

However, “we’re not really sure that it improves outcomes,” he said.
 

A chronic issue?

“Do you think it’s really an issue of the patients being critically ill with vitamin D,” or is it “a chronic issue of having low vitamin D?” asked session moderator Antine Stenbit, MD, PhD, from the University of California, San Diego.

“We don’t know for sure,” Dr. Rice said. Vitamin D might not have a lot of acute effects; it might have effects that are chronic, that work with levels over a period of time, he explained.

“It’s not clear we can correct that with a single dose or with a few days of giving a level that is adequate,” he acknowledged.

Dr. Rice is an investigator in the PETAL network. Dr. Stenbit disclosed no relevant financial relationships.

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

The COVID-19 pandemic has thrown a monkey wrench into the medical education landscape across the entire health care spectrum, disrupting the plans of medical students, residents, fellows, and program directors.

As cases of COVID-19 spread across the United States in early 2020, it became clear to training program directors that immediate action was required to meet the needs of medical learners. The challenges were unlike those surrounding the Ebola virus in 2014, “where we could more easily prevent students and trainees from exposure due to the fact that there were simply not significant numbers of cases in the United States,” Tiffany Murano, MD, said at a Society for Critical Care virtual meeting: COVID-19: What’s Next. Dr. Murano is professor of emergency medicine at Rutgers New Jersey Medical School, Newark, and president-elect of the Council of Residency Directors in Emergency Medicine. “COVID was a completely different scenario. We quickly realized that not only was personal protective equipment in short supply, but we also lacked the testing and tracking capabilities for potential exposures. Medical students and other supportive workers who were considered nonessential were removed from the clinical setting. This was after a trial of limiting who the students saw, essentially dampening the risk of exposure. But this proved to be flawed as COVID patients presented with symptoms that were unexpected.”

To complicate matters, she continued, many medical clinics either shut down, had limited access, or converted to telemedicine. Elective surgeries were canceled. This led to an overall pause in clinical medical student rotations and no direct patient care activities. As social distancing mandates were instituted, licensing examination testing centers were closed, and exams and on-campus activities were postponed.
 

Limiting trainee exposure

On the graduate medical education front, some training programs attempted to limit exposure of their trainees to persons under investigation for COVID-19. “As the number of COVID cases grew and encompassed most of what we were seeing in the hospital, it was obvious that residents had to play a vital part in the care of these patients,” said Dr. Murano, who is also a member of the American Council of Graduate Medical Education’s emergency review and recognition committee. “However, there was a consensus among all of the specialties that the procedures that posed the highest risk of exposure would be limited to the most senior or experienced trainees or professionals, and closely supervised by the faculty.”

ACGME activities such as accreditation site visits, clinical environment learning reviews, self-study, and resident and faculty surveys were suspended, postponed, or modified in some way, she said. The ACGME created stages of COVID status to guide sponsoring institutions to suspend learning curricula in order for patients to be cared for. Stage 1 was business as usual, “so there was no significant impact on patient care,” Dr. Murano said. “Stage 2 was increased but manageable clinical demand, while stage 3 was pandemic emergency status, where there were extraordinary circumstances where the clinical demand was so high and strenuous that the routine patient care and education really needed to be reconfigured in order to care for the patients.”

New requirements to manage training

The ACGME also implemented four requirements to manage training that were consistent among institutions, regardless of their COVID stage status. These included making sure that trainees continued to be held to work-hour limit requirements, ensuring adequate resources for training, ensuring that all residents had the appropriate level of supervision at all times, and allowing fellows to function in the core specialty in which they completed their residency training. “This was only possible if the fellows were ABMS [American Board of Medical Specialties] or AOA [American Osteopathic Association] board-eligible, or certified in their core specialty,” Dr. Murano said. “The fellows had to be appointed to the medical staff at the sponsoring institution, and their time spent on the core specialty service would be limited to 20% of their annual education time in any academic year.”

Mindful that there may have been trainees who required a 2-week quarantine period following exposure or potential exposure to COVID-19, some specialty boards showed leniency in residency time required to sit for the written exam. “Testing centers were being forced to close to observe social distancing requirements and heed sanitation recommendations, so exams were either canceled or postponed,” Dr. Murano said. “This posed a special concern for the board certification process, and those specialties with oral examinations had to make a heavy decision regarding whether or not they would allow these exams to take place. Naturally, travel among institutions was suspended or limited, or had quarantine requirements upon returning home from endemic areas. Conferences were either being canceled or converted to virtual formats.”

Subani Chandra, MD, FCCP, of the division of pulmonary, allergy, and critical care medicine at Columbia University, New York, is the internal medicine residency program director and the associate vice-chair of education for the department of medicine, and she recognized the problem created for medical trainees by the changes necessitated by the pandemic.

“The variability in caseloads and clinical exposure has given thrust to the move toward competency-based assessments rather than number- or time-based criteria for determining proficiency and graduation,” she wrote in an email interview. In addition, she noted the impact on medical meetings and the need to adapt. “Early on, before large regional and national conferences adapted to a virtual format, many were canceled altogether. Students, residents, and fellows expecting to have the opportunity to present their scholarly work were suddenly no longer able to do so. Understanding the importance of scholarly interaction, the virtual format of CHEST 2020 is designed with opportunities to present, interact with experts in the field, ask questions, network, and meet mentors.”

No return to ‘normal’

By April 2020, cases in the northeast continued to rise, particularly in the New York, New Jersey, and Connecticut region. “These states were essentially shut down in order to contain spread of the virus,” she said. “This was a real turning point because we realized that things were not going to return to ‘normal’ in the foreseeable future.” With the clinical experience essentially halted for medical students during this time, some medical schools allowed their senior students who met requirements to graduate early. “There were a lot of mixed feelings about this, recognizing that PPE [personal protective equipment] was still in short supply in many areas,” Dr. Murano said. “So, institutions took on these early graduates into roles in which they were not learners in particular, but rather medical workers. They were helping with informatics and technology, telehealth, virtual or telephone call follow-ups, and other tasks like this. There was a movement to virtual learning for the preclinical undergraduate learners, so classes were now online, recorded, or livestreamed.”
 

Early graduation, matching, and residencies

On April 3, the ACGME released a statement regarding graduating students early and appointing them early to the clinical learning environment. “They pointed out that institutions that were in emergency pandemic status lacked the ability to offer the comprehensive orientation and training in PPE and direct supervision required for new residents at the start of their residency,” Dr. Murano said. “Their opinion maintained that graduating medical students matriculate in their previously matched program, the National Resident Match Program start date, or other date that would be nationally determined to be the beginning of the 2020-2021 academic year.”

As May 2020 rolled around, the overriding feeling was uncertainty regarding when, if, and how medical schools were going to open in the early summer and fall. “There was also uncertainty about how graduating medical students were going to function in their new role as residents,” she said. “Same for the graduating residents. There were some who had signed contracts for jobs months before, and had them rescinded, and physicians were being furloughed due to financial hardships that institutions faced. There was also postponement of board certification exams, so people were uncertain about when they would become board certified.”

July 2020 ushered in what Dr. Murano characterized as “a whole new level of stress.” For medical students in particular, “we were entering the application season for residency positions,” she said. “Due to travel restrictions placed by various states and institutions, away rotations were limited or nonexistent. Application release dates through the Electronic Residency Application Service were moved to later in the year. The United States Medical Licensing Examination clinical skills exam was suspended, and there were modifications made for Education Commission for Foreign Medical Graduates requirements. Letters of recommendation were also going to be limited, so there had to be some degree of leniency within specialties to take a more holistic approach to review of applications for residencies.”

On the graduate medical education front, the ACGME sunsetted the initial stages and created two categories: nonemergency, which was formerly stages 1 and 2, and emergency, which was formerly stage 3. “All emergency stages are applied for and granted at 1-month intervals,” Dr. Murano said. Board certification exams were modified to accommodate either later exams or online formats, and specialties with oral examinations faced the task of potentially creating virtual oral exams.

Despite the challenges, Dr. Chandra has seen medical training programs respond with new ideas. “The flexibility and agile adaptability of the entire educational enterprise has been remarkable. The inherent uncertainty in a very dynamic and changing learning environment can be challenging. Recognizing this, many programs are creating additional ways to support the mental, emotional, physical, and financial health of students, residents, and fellows and all health care workers. The importance of this innovative response cannot be overstated.”
 

New learning formats

The pandemic forced Dr. Murano and other medical educators to consider unorthodox learning formats, and virtual learning took center stage. “Residency programs had shared national livestream conferences and grand rounds, and there were virtual curricula made for medical students as well as virtual simulation,” she said. “Telemedicine and telehealth really became important parts of education as well, as this may have been the only face-to-face contact that students and residents had with patients who had non–COVID-related complaints.”

To level the playing field for medical residents during this unprecedented time, a work group of the Coalition for Physician Accountability developed a set of recommendations that include limiting the number of letters of recommendation accepted, limiting the number of away rotations, and allowing alternative or less conventional letters of recommendation. “Keeping an open mind and taking a more holistic approach to applicants has really been needed during this time,” Dr. Murano said. “Virtual interview days have been agreed upon for all specialties. They’re safer, and they allow for students to virtually meet faculty and residents from distant programs that in the past would have been a deterrent due to distance and travel costs. This is not without its own downside, as it’s difficult to determine how well a student will fit into a program without [him or her] actually visiting the institution.”

Dr. Chandra agreed that virtual interviews are necessary but have inherent limitations. However, “we will all learn a lot, and very likely the future process will blend the benefits of both virtual and in-person interviews.”
 

‘We need to keep moving forward’

Dr. Murano concluded her presentation by noting that the COVID-19 pandemic has created opportunities for growth and innovation in medical education, “so we need to keep moving forward. I’ve heard many say that they can’t wait for things to go back to normal. But I think it’s important to go ahead to new and better ways of learning. We’re now thinking outside of the typical education model and are embracing technology and alternative means of education. We don’t know yet if this education is better, worse, or equivalent to traditional methods, but that will be determined and studied in months and years to come, so we’re certainly looking to the future.”

Dr. Murano and Dr. Chandra reported having no financial disclosures.

[email protected]

The COVID-19 pandemic has thrown a monkey wrench into the medical education landscape across the entire health care spectrum, disrupting the plans of medical students, residents, fellows, and program directors.

As cases of COVID-19 spread across the United States in early 2020, it became clear to training program directors that immediate action was required to meet the needs of medical learners. The challenges were unlike those surrounding the Ebola virus in 2014, “where we could more easily prevent students and trainees from exposure due to the fact that there were simply not significant numbers of cases in the United States,” Tiffany Murano, MD, said at a Society for Critical Care virtual meeting: COVID-19: What’s Next. Dr. Murano is professor of emergency medicine at Rutgers New Jersey Medical School, Newark, and president-elect of the Council of Residency Directors in Emergency Medicine. “COVID was a completely different scenario. We quickly realized that not only was personal protective equipment in short supply, but we also lacked the testing and tracking capabilities for potential exposures. Medical students and other supportive workers who were considered nonessential were removed from the clinical setting. This was after a trial of limiting who the students saw, essentially dampening the risk of exposure. But this proved to be flawed as COVID patients presented with symptoms that were unexpected.”

To complicate matters, she continued, many medical clinics either shut down, had limited access, or converted to telemedicine. Elective surgeries were canceled. This led to an overall pause in clinical medical student rotations and no direct patient care activities. As social distancing mandates were instituted, licensing examination testing centers were closed, and exams and on-campus activities were postponed.
 

Limiting trainee exposure

On the graduate medical education front, some training programs attempted to limit exposure of their trainees to persons under investigation for COVID-19. “As the number of COVID cases grew and encompassed most of what we were seeing in the hospital, it was obvious that residents had to play a vital part in the care of these patients,” said Dr. Murano, who is also a member of the American Council of Graduate Medical Education’s emergency review and recognition committee. “However, there was a consensus among all of the specialties that the procedures that posed the highest risk of exposure would be limited to the most senior or experienced trainees or professionals, and closely supervised by the faculty.”

ACGME activities such as accreditation site visits, clinical environment learning reviews, self-study, and resident and faculty surveys were suspended, postponed, or modified in some way, she said. The ACGME created stages of COVID status to guide sponsoring institutions to suspend learning curricula in order for patients to be cared for. Stage 1 was business as usual, “so there was no significant impact on patient care,” Dr. Murano said. “Stage 2 was increased but manageable clinical demand, while stage 3 was pandemic emergency status, where there were extraordinary circumstances where the clinical demand was so high and strenuous that the routine patient care and education really needed to be reconfigured in order to care for the patients.”

New requirements to manage training

The ACGME also implemented four requirements to manage training that were consistent among institutions, regardless of their COVID stage status. These included making sure that trainees continued to be held to work-hour limit requirements, ensuring adequate resources for training, ensuring that all residents had the appropriate level of supervision at all times, and allowing fellows to function in the core specialty in which they completed their residency training. “This was only possible if the fellows were ABMS [American Board of Medical Specialties] or AOA [American Osteopathic Association] board-eligible, or certified in their core specialty,” Dr. Murano said. “The fellows had to be appointed to the medical staff at the sponsoring institution, and their time spent on the core specialty service would be limited to 20% of their annual education time in any academic year.”

Mindful that there may have been trainees who required a 2-week quarantine period following exposure or potential exposure to COVID-19, some specialty boards showed leniency in residency time required to sit for the written exam. “Testing centers were being forced to close to observe social distancing requirements and heed sanitation recommendations, so exams were either canceled or postponed,” Dr. Murano said. “This posed a special concern for the board certification process, and those specialties with oral examinations had to make a heavy decision regarding whether or not they would allow these exams to take place. Naturally, travel among institutions was suspended or limited, or had quarantine requirements upon returning home from endemic areas. Conferences were either being canceled or converted to virtual formats.”

Subani Chandra, MD, FCCP, of the division of pulmonary, allergy, and critical care medicine at Columbia University, New York, is the internal medicine residency program director and the associate vice-chair of education for the department of medicine, and she recognized the problem created for medical trainees by the changes necessitated by the pandemic.

“The variability in caseloads and clinical exposure has given thrust to the move toward competency-based assessments rather than number- or time-based criteria for determining proficiency and graduation,” she wrote in an email interview. In addition, she noted the impact on medical meetings and the need to adapt. “Early on, before large regional and national conferences adapted to a virtual format, many were canceled altogether. Students, residents, and fellows expecting to have the opportunity to present their scholarly work were suddenly no longer able to do so. Understanding the importance of scholarly interaction, the virtual format of CHEST 2020 is designed with opportunities to present, interact with experts in the field, ask questions, network, and meet mentors.”

No return to ‘normal’

By April 2020, cases in the northeast continued to rise, particularly in the New York, New Jersey, and Connecticut region. “These states were essentially shut down in order to contain spread of the virus,” she said. “This was a real turning point because we realized that things were not going to return to ‘normal’ in the foreseeable future.” With the clinical experience essentially halted for medical students during this time, some medical schools allowed their senior students who met requirements to graduate early. “There were a lot of mixed feelings about this, recognizing that PPE [personal protective equipment] was still in short supply in many areas,” Dr. Murano said. “So, institutions took on these early graduates into roles in which they were not learners in particular, but rather medical workers. They were helping with informatics and technology, telehealth, virtual or telephone call follow-ups, and other tasks like this. There was a movement to virtual learning for the preclinical undergraduate learners, so classes were now online, recorded, or livestreamed.”
 

Early graduation, matching, and residencies

On April 3, the ACGME released a statement regarding graduating students early and appointing them early to the clinical learning environment. “They pointed out that institutions that were in emergency pandemic status lacked the ability to offer the comprehensive orientation and training in PPE and direct supervision required for new residents at the start of their residency,” Dr. Murano said. “Their opinion maintained that graduating medical students matriculate in their previously matched program, the National Resident Match Program start date, or other date that would be nationally determined to be the beginning of the 2020-2021 academic year.”

As May 2020 rolled around, the overriding feeling was uncertainty regarding when, if, and how medical schools were going to open in the early summer and fall. “There was also uncertainty about how graduating medical students were going to function in their new role as residents,” she said. “Same for the graduating residents. There were some who had signed contracts for jobs months before, and had them rescinded, and physicians were being furloughed due to financial hardships that institutions faced. There was also postponement of board certification exams, so people were uncertain about when they would become board certified.”

July 2020 ushered in what Dr. Murano characterized as “a whole new level of stress.” For medical students in particular, “we were entering the application season for residency positions,” she said. “Due to travel restrictions placed by various states and institutions, away rotations were limited or nonexistent. Application release dates through the Electronic Residency Application Service were moved to later in the year. The United States Medical Licensing Examination clinical skills exam was suspended, and there were modifications made for Education Commission for Foreign Medical Graduates requirements. Letters of recommendation were also going to be limited, so there had to be some degree of leniency within specialties to take a more holistic approach to review of applications for residencies.”

On the graduate medical education front, the ACGME sunsetted the initial stages and created two categories: nonemergency, which was formerly stages 1 and 2, and emergency, which was formerly stage 3. “All emergency stages are applied for and granted at 1-month intervals,” Dr. Murano said. Board certification exams were modified to accommodate either later exams or online formats, and specialties with oral examinations faced the task of potentially creating virtual oral exams.

Despite the challenges, Dr. Chandra has seen medical training programs respond with new ideas. “The flexibility and agile adaptability of the entire educational enterprise has been remarkable. The inherent uncertainty in a very dynamic and changing learning environment can be challenging. Recognizing this, many programs are creating additional ways to support the mental, emotional, physical, and financial health of students, residents, and fellows and all health care workers. The importance of this innovative response cannot be overstated.”
 

New learning formats

The pandemic forced Dr. Murano and other medical educators to consider unorthodox learning formats, and virtual learning took center stage. “Residency programs had shared national livestream conferences and grand rounds, and there were virtual curricula made for medical students as well as virtual simulation,” she said. “Telemedicine and telehealth really became important parts of education as well, as this may have been the only face-to-face contact that students and residents had with patients who had non–COVID-related complaints.”

To level the playing field for medical residents during this unprecedented time, a work group of the Coalition for Physician Accountability developed a set of recommendations that include limiting the number of letters of recommendation accepted, limiting the number of away rotations, and allowing alternative or less conventional letters of recommendation. “Keeping an open mind and taking a more holistic approach to applicants has really been needed during this time,” Dr. Murano said. “Virtual interview days have been agreed upon for all specialties. They’re safer, and they allow for students to virtually meet faculty and residents from distant programs that in the past would have been a deterrent due to distance and travel costs. This is not without its own downside, as it’s difficult to determine how well a student will fit into a program without [him or her] actually visiting the institution.”

Dr. Chandra agreed that virtual interviews are necessary but have inherent limitations. However, “we will all learn a lot, and very likely the future process will blend the benefits of both virtual and in-person interviews.”
 

‘We need to keep moving forward’

Dr. Murano concluded her presentation by noting that the COVID-19 pandemic has created opportunities for growth and innovation in medical education, “so we need to keep moving forward. I’ve heard many say that they can’t wait for things to go back to normal. But I think it’s important to go ahead to new and better ways of learning. We’re now thinking outside of the typical education model and are embracing technology and alternative means of education. We don’t know yet if this education is better, worse, or equivalent to traditional methods, but that will be determined and studied in months and years to come, so we’re certainly looking to the future.”

Dr. Murano and Dr. Chandra reported having no financial disclosures.

[email protected]

The COVID-19 pandemic has thrown a monkey wrench into the medical education landscape across the entire health care spectrum, disrupting the plans of medical students, residents, fellows, and program directors.

As cases of COVID-19 spread across the United States in early 2020, it became clear to training program directors that immediate action was required to meet the needs of medical learners. The challenges were unlike those surrounding the Ebola virus in 2014, “where we could more easily prevent students and trainees from exposure due to the fact that there were simply not significant numbers of cases in the United States,” Tiffany Murano, MD, said at a Society for Critical Care virtual meeting: COVID-19: What’s Next. Dr. Murano is professor of emergency medicine at Rutgers New Jersey Medical School, Newark, and president-elect of the Council of Residency Directors in Emergency Medicine. “COVID was a completely different scenario. We quickly realized that not only was personal protective equipment in short supply, but we also lacked the testing and tracking capabilities for potential exposures. Medical students and other supportive workers who were considered nonessential were removed from the clinical setting. This was after a trial of limiting who the students saw, essentially dampening the risk of exposure. But this proved to be flawed as COVID patients presented with symptoms that were unexpected.”

To complicate matters, she continued, many medical clinics either shut down, had limited access, or converted to telemedicine. Elective surgeries were canceled. This led to an overall pause in clinical medical student rotations and no direct patient care activities. As social distancing mandates were instituted, licensing examination testing centers were closed, and exams and on-campus activities were postponed.
 

Limiting trainee exposure

On the graduate medical education front, some training programs attempted to limit exposure of their trainees to persons under investigation for COVID-19. “As the number of COVID cases grew and encompassed most of what we were seeing in the hospital, it was obvious that residents had to play a vital part in the care of these patients,” said Dr. Murano, who is also a member of the American Council of Graduate Medical Education’s emergency review and recognition committee. “However, there was a consensus among all of the specialties that the procedures that posed the highest risk of exposure would be limited to the most senior or experienced trainees or professionals, and closely supervised by the faculty.”

ACGME activities such as accreditation site visits, clinical environment learning reviews, self-study, and resident and faculty surveys were suspended, postponed, or modified in some way, she said. The ACGME created stages of COVID status to guide sponsoring institutions to suspend learning curricula in order for patients to be cared for. Stage 1 was business as usual, “so there was no significant impact on patient care,” Dr. Murano said. “Stage 2 was increased but manageable clinical demand, while stage 3 was pandemic emergency status, where there were extraordinary circumstances where the clinical demand was so high and strenuous that the routine patient care and education really needed to be reconfigured in order to care for the patients.”

New requirements to manage training

The ACGME also implemented four requirements to manage training that were consistent among institutions, regardless of their COVID stage status. These included making sure that trainees continued to be held to work-hour limit requirements, ensuring adequate resources for training, ensuring that all residents had the appropriate level of supervision at all times, and allowing fellows to function in the core specialty in which they completed their residency training. “This was only possible if the fellows were ABMS [American Board of Medical Specialties] or AOA [American Osteopathic Association] board-eligible, or certified in their core specialty,” Dr. Murano said. “The fellows had to be appointed to the medical staff at the sponsoring institution, and their time spent on the core specialty service would be limited to 20% of their annual education time in any academic year.”

Mindful that there may have been trainees who required a 2-week quarantine period following exposure or potential exposure to COVID-19, some specialty boards showed leniency in residency time required to sit for the written exam. “Testing centers were being forced to close to observe social distancing requirements and heed sanitation recommendations, so exams were either canceled or postponed,” Dr. Murano said. “This posed a special concern for the board certification process, and those specialties with oral examinations had to make a heavy decision regarding whether or not they would allow these exams to take place. Naturally, travel among institutions was suspended or limited, or had quarantine requirements upon returning home from endemic areas. Conferences were either being canceled or converted to virtual formats.”

Subani Chandra, MD, FCCP, of the division of pulmonary, allergy, and critical care medicine at Columbia University, New York, is the internal medicine residency program director and the associate vice-chair of education for the department of medicine, and she recognized the problem created for medical trainees by the changes necessitated by the pandemic.

“The variability in caseloads and clinical exposure has given thrust to the move toward competency-based assessments rather than number- or time-based criteria for determining proficiency and graduation,” she wrote in an email interview. In addition, she noted the impact on medical meetings and the need to adapt. “Early on, before large regional and national conferences adapted to a virtual format, many were canceled altogether. Students, residents, and fellows expecting to have the opportunity to present their scholarly work were suddenly no longer able to do so. Understanding the importance of scholarly interaction, the virtual format of CHEST 2020 is designed with opportunities to present, interact with experts in the field, ask questions, network, and meet mentors.”

No return to ‘normal’

By April 2020, cases in the northeast continued to rise, particularly in the New York, New Jersey, and Connecticut region. “These states were essentially shut down in order to contain spread of the virus,” she said. “This was a real turning point because we realized that things were not going to return to ‘normal’ in the foreseeable future.” With the clinical experience essentially halted for medical students during this time, some medical schools allowed their senior students who met requirements to graduate early. “There were a lot of mixed feelings about this, recognizing that PPE [personal protective equipment] was still in short supply in many areas,” Dr. Murano said. “So, institutions took on these early graduates into roles in which they were not learners in particular, but rather medical workers. They were helping with informatics and technology, telehealth, virtual or telephone call follow-ups, and other tasks like this. There was a movement to virtual learning for the preclinical undergraduate learners, so classes were now online, recorded, or livestreamed.”
 

Early graduation, matching, and residencies

On April 3, the ACGME released a statement regarding graduating students early and appointing them early to the clinical learning environment. “They pointed out that institutions that were in emergency pandemic status lacked the ability to offer the comprehensive orientation and training in PPE and direct supervision required for new residents at the start of their residency,” Dr. Murano said. “Their opinion maintained that graduating medical students matriculate in their previously matched program, the National Resident Match Program start date, or other date that would be nationally determined to be the beginning of the 2020-2021 academic year.”

As May 2020 rolled around, the overriding feeling was uncertainty regarding when, if, and how medical schools were going to open in the early summer and fall. “There was also uncertainty about how graduating medical students were going to function in their new role as residents,” she said. “Same for the graduating residents. There were some who had signed contracts for jobs months before, and had them rescinded, and physicians were being furloughed due to financial hardships that institutions faced. There was also postponement of board certification exams, so people were uncertain about when they would become board certified.”

July 2020 ushered in what Dr. Murano characterized as “a whole new level of stress.” For medical students in particular, “we were entering the application season for residency positions,” she said. “Due to travel restrictions placed by various states and institutions, away rotations were limited or nonexistent. Application release dates through the Electronic Residency Application Service were moved to later in the year. The United States Medical Licensing Examination clinical skills exam was suspended, and there were modifications made for Education Commission for Foreign Medical Graduates requirements. Letters of recommendation were also going to be limited, so there had to be some degree of leniency within specialties to take a more holistic approach to review of applications for residencies.”

On the graduate medical education front, the ACGME sunsetted the initial stages and created two categories: nonemergency, which was formerly stages 1 and 2, and emergency, which was formerly stage 3. “All emergency stages are applied for and granted at 1-month intervals,” Dr. Murano said. Board certification exams were modified to accommodate either later exams or online formats, and specialties with oral examinations faced the task of potentially creating virtual oral exams.

Despite the challenges, Dr. Chandra has seen medical training programs respond with new ideas. “The flexibility and agile adaptability of the entire educational enterprise has been remarkable. The inherent uncertainty in a very dynamic and changing learning environment can be challenging. Recognizing this, many programs are creating additional ways to support the mental, emotional, physical, and financial health of students, residents, and fellows and all health care workers. The importance of this innovative response cannot be overstated.”
 

New learning formats

The pandemic forced Dr. Murano and other medical educators to consider unorthodox learning formats, and virtual learning took center stage. “Residency programs had shared national livestream conferences and grand rounds, and there were virtual curricula made for medical students as well as virtual simulation,” she said. “Telemedicine and telehealth really became important parts of education as well, as this may have been the only face-to-face contact that students and residents had with patients who had non–COVID-related complaints.”

To level the playing field for medical residents during this unprecedented time, a work group of the Coalition for Physician Accountability developed a set of recommendations that include limiting the number of letters of recommendation accepted, limiting the number of away rotations, and allowing alternative or less conventional letters of recommendation. “Keeping an open mind and taking a more holistic approach to applicants has really been needed during this time,” Dr. Murano said. “Virtual interview days have been agreed upon for all specialties. They’re safer, and they allow for students to virtually meet faculty and residents from distant programs that in the past would have been a deterrent due to distance and travel costs. This is not without its own downside, as it’s difficult to determine how well a student will fit into a program without [him or her] actually visiting the institution.”

Dr. Chandra agreed that virtual interviews are necessary but have inherent limitations. However, “we will all learn a lot, and very likely the future process will blend the benefits of both virtual and in-person interviews.”
 

‘We need to keep moving forward’

Dr. Murano concluded her presentation by noting that the COVID-19 pandemic has created opportunities for growth and innovation in medical education, “so we need to keep moving forward. I’ve heard many say that they can’t wait for things to go back to normal. But I think it’s important to go ahead to new and better ways of learning. We’re now thinking outside of the typical education model and are embracing technology and alternative means of education. We don’t know yet if this education is better, worse, or equivalent to traditional methods, but that will be determined and studied in months and years to come, so we’re certainly looking to the future.”

Dr. Murano and Dr. Chandra reported having no financial disclosures.

[email protected]

In late March, shortly after New York state closed nonessential businesses and asked people to stay home, Ashley Laderer began waking each morning with a throbbing headache.

“The pressure was so intense it felt like my head was going to explode,” recalled the 27-year-old freelance writer from Long Island.

klebercordeiro/Getty Images

She tried spending less time on the computer and taking over-the-counter pain medication, but the pounding kept breaking through – a constant drumbeat to accompany her equally incessant worries about COVID-19.

“Every day I lived in fear that I was going to get it and I was going to infect my whole family,” she said.

After a month and a half, Ms. Laderer decided to visit a neurologist, who ordered an MRI. But the doctor found no physical cause. The scan was clear.

Then he asked: “Are you under a lot of stress?”

Throughout the pandemic, people who never had the coronavirus have been reporting a host of seemingly unrelated symptoms: excruciating headaches, episodes of hair loss, upset stomach for weeks on end, sudden outbreaks of shingles, and flare-ups of autoimmune disorders. The disparate symptoms, often in otherwise-healthy individuals, have puzzled doctors and patients alike, sometimes resulting in a series of visits to specialists with few answers. But it turns out there’s a common thread among many of these conditions, one that has been months in the making: chronic stress.

Although people often underestimate the influence of the mind on the body, a growing catalog of research shows that high levels of stress over an extended time can drastically alter physical function and affect nearly every organ system.

Now, at least 8 months into the pandemic, alongside a divisive election cycle and racial unrest, those effects are showing up in a variety of symptoms.

“The mental health component of COVID is starting to come like a tsunami,” said Jennifer Love, MD, a California-based psychiatrist and coauthor of an upcoming book on how to heal from chronic stress.

Nationwide, surveys have found increasing rates of depression, anxiety and suicidal thoughts during the pandemic. But many medical experts said it’s too soon to measure the related physical symptoms, since they generally appear months after the stress begins.

Still, some early research, such as a small Chinese study and an online survey of more than 500 people in Turkey, points to an uptick.

In the United States, data from FAIR Health, a nonprofit database that provides cost information to the health industry and consumers, showed slight to moderate increases in the percentage of medical claims related to conditions triggered or exacerbated by stress, like multiple sclerosis and shingles. The portion of claims for the autoimmune disease lupus, for example, showed one of the biggest increases – 12% this year – compared with the same period last year (January to August).

Express Scripts, a major pharmacy benefit manager, reported that prescriptions for anti-insomnia medications increased 15% early in the pandemic.

Perhaps the strongest indicator comes from doctors reporting a growing number of patients with physical symptoms for which they can’t determine a cause.

Shilpi Khetarpal, MD, a dermatologist at the Cleveland Clinic, used to see about five patients a week with stress-related hair loss. Since mid-June, that number has jumped to 20 or 25. Mostly women, ages 20-80, are reporting hair coming out in fistfuls, Dr. Khetarpal said.

In Houston, at least a dozen patients have told fertility specialist Rashmi Kudesia, MD, they’re having irregular menstrual cycles, changes in cervical discharge and breast tenderness, despite normal hormone levels.

Stress is also the culprit dentists are pointing to for the rapid increase in patients with teeth grinding, teeth fractures, and temporomandibular joint dysfunction.

“We, as humans, like to have the idea that we are in control of our minds and that stress isn’t a big deal,” Dr. Love said. “But it’s simply not true.”
 

How mental stress becomes physical

Stress causes physical changes in the body that can affect nearly every organ system.

Although symptoms of chronic stress are often dismissed as being in one’s head, the pain is very real, said Kate Harkness, PhD, a professor of psychology and psychiatry at Queen’s University, Kingston, Ont.

When the body feels unsafe – whether it’s a physical threat of attack or a psychological fear of losing a job or catching a disease – the brain signals adrenal glands to pump stress hormones. Adrenaline and cortisol flood the body, activating the fight-or-flight response. They also disrupt bodily functions that aren’t necessary for immediate survival, like digestion and reproduction.

When the danger is over, the hormones return to normal levels. But during times of chronic stress, like a pandemic, the body keeps pumping out stress hormones until it tires itself out. This leads to increased inflammation throughout the body and brain, and a poorly functioning immune system.

Studies link chronic stress to heart disease, muscle tension, gastrointestinal issues and even physical shrinking of the hippocampus, an area of the brain associated with memory and learning. As the immune system acts up, some people can even develop new allergic reactions, Dr. Harkness said.

The good news is that many of these symptoms are reversible. But it’s important to recognize them early, especially when it comes to the brain, said Barbara Sahakian, FBA, FMedSci, a professor of clinical neuropsychology at the University of Cambridge (England).

“The brain is plastic, so we can to some extent modify it,” Dr. Sahakian said. “But we don’t know if there’s a cliff beyond which you can’t reverse a change. So the sooner you catch something, the better.”
 

The day-to-day impact

In some ways, mental health awareness has increased during the pandemic. TV shows are flush with ads for therapy and meditation apps, like Talkspace and Calm, and companies are announcing mental health days off for staff. But those spurts of attention fail to reveal the full impact of poor mental health on people’s daily lives.

For Alex Kostka, pandemic-related stress has brought on mood swings, nightmares, and jaw pain.

He’d been working at a Whole Foods coffee bar in New York City for only about a month before the pandemic hit, suddenly anointing him an essential worker. As deaths in the city soared, Mr. Kostka continued riding the subway to work, interacting with coworkers in the store and working longer hours for just a $2-per-hour wage increase. (Months later, he’d get a $500 bonus.) It left the 28-year-old feeling constantly unsafe and helpless.

“It was hard not to break down on the subway the minute I got on it,” Mr. Kostka said.

Soon he began waking in the middle of the night with pain from clenching his jaw so tightly. Often his teeth grinding and chomping were loud enough to wake his girlfriend.

Mr. Kostka tried Talkspace, but found texting about his troubles felt impersonal. By the end of the summer, he decided to start using the seven free counseling sessions offered by his employer. That’s helped, he said. But as the sessions run out, he worries the symptoms might return if he’s unable to find a new therapist covered by his insurance.

“Eventually, I will be able to leave this behind me, but it will take time,” Mr. Kostka said. “I’m still very much a work in progress.”
 

How to mitigate chronic stress

When it comes to chronic stress, seeing a doctor for stomach pain, headaches, or skin rashes may address those physical symptoms. But the root cause is mental, medical experts said.

That means the solution will often involve stress-management techniques. And there’s plenty we can do to feel better:

• Exercise. Even low- to moderate-intensity physical activity can help counteract stress-induced inflammation in the body. It can also increase neuronal connections in the brain.
• Meditation and mindfulness. Research shows this can lead to positive, structural, and functional changes in the brain.
• Fostering social connections. Talking to family and friends, even virtually, or staring into a pet’s eyes can release a hormone that may counteract inflammation.
• Learning something new. Whether it’s a formal class or taking up a casual hobby, learning supports brain plasticity, the ability to change and adapt as a result of experience, which can be protective against depression and other mental illness.

“We shouldn’t think of this stressful situation as a negative sentence for the brain,” said Dr. Harkness. “Because stress changes the brain, that means positive stuff can change the brain, too. And there is plenty we can do to help ourselves feel better in the face of adversity.”

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

In late March, shortly after New York state closed nonessential businesses and asked people to stay home, Ashley Laderer began waking each morning with a throbbing headache.

“The pressure was so intense it felt like my head was going to explode,” recalled the 27-year-old freelance writer from Long Island.

klebercordeiro/Getty Images

She tried spending less time on the computer and taking over-the-counter pain medication, but the pounding kept breaking through – a constant drumbeat to accompany her equally incessant worries about COVID-19.

“Every day I lived in fear that I was going to get it and I was going to infect my whole family,” she said.

After a month and a half, Ms. Laderer decided to visit a neurologist, who ordered an MRI. But the doctor found no physical cause. The scan was clear.

Then he asked: “Are you under a lot of stress?”

Throughout the pandemic, people who never had the coronavirus have been reporting a host of seemingly unrelated symptoms: excruciating headaches, episodes of hair loss, upset stomach for weeks on end, sudden outbreaks of shingles, and flare-ups of autoimmune disorders. The disparate symptoms, often in otherwise-healthy individuals, have puzzled doctors and patients alike, sometimes resulting in a series of visits to specialists with few answers. But it turns out there’s a common thread among many of these conditions, one that has been months in the making: chronic stress.

Although people often underestimate the influence of the mind on the body, a growing catalog of research shows that high levels of stress over an extended time can drastically alter physical function and affect nearly every organ system.

Now, at least 8 months into the pandemic, alongside a divisive election cycle and racial unrest, those effects are showing up in a variety of symptoms.

“The mental health component of COVID is starting to come like a tsunami,” said Jennifer Love, MD, a California-based psychiatrist and coauthor of an upcoming book on how to heal from chronic stress.

Nationwide, surveys have found increasing rates of depression, anxiety and suicidal thoughts during the pandemic. But many medical experts said it’s too soon to measure the related physical symptoms, since they generally appear months after the stress begins.

Still, some early research, such as a small Chinese study and an online survey of more than 500 people in Turkey, points to an uptick.

In the United States, data from FAIR Health, a nonprofit database that provides cost information to the health industry and consumers, showed slight to moderate increases in the percentage of medical claims related to conditions triggered or exacerbated by stress, like multiple sclerosis and shingles. The portion of claims for the autoimmune disease lupus, for example, showed one of the biggest increases – 12% this year – compared with the same period last year (January to August).

Express Scripts, a major pharmacy benefit manager, reported that prescriptions for anti-insomnia medications increased 15% early in the pandemic.

Perhaps the strongest indicator comes from doctors reporting a growing number of patients with physical symptoms for which they can’t determine a cause.

Shilpi Khetarpal, MD, a dermatologist at the Cleveland Clinic, used to see about five patients a week with stress-related hair loss. Since mid-June, that number has jumped to 20 or 25. Mostly women, ages 20-80, are reporting hair coming out in fistfuls, Dr. Khetarpal said.

In Houston, at least a dozen patients have told fertility specialist Rashmi Kudesia, MD, they’re having irregular menstrual cycles, changes in cervical discharge and breast tenderness, despite normal hormone levels.

Stress is also the culprit dentists are pointing to for the rapid increase in patients with teeth grinding, teeth fractures, and temporomandibular joint dysfunction.

“We, as humans, like to have the idea that we are in control of our minds and that stress isn’t a big deal,” Dr. Love said. “But it’s simply not true.”
 

How mental stress becomes physical

Stress causes physical changes in the body that can affect nearly every organ system.

Although symptoms of chronic stress are often dismissed as being in one’s head, the pain is very real, said Kate Harkness, PhD, a professor of psychology and psychiatry at Queen’s University, Kingston, Ont.

When the body feels unsafe – whether it’s a physical threat of attack or a psychological fear of losing a job or catching a disease – the brain signals adrenal glands to pump stress hormones. Adrenaline and cortisol flood the body, activating the fight-or-flight response. They also disrupt bodily functions that aren’t necessary for immediate survival, like digestion and reproduction.

When the danger is over, the hormones return to normal levels. But during times of chronic stress, like a pandemic, the body keeps pumping out stress hormones until it tires itself out. This leads to increased inflammation throughout the body and brain, and a poorly functioning immune system.

Studies link chronic stress to heart disease, muscle tension, gastrointestinal issues and even physical shrinking of the hippocampus, an area of the brain associated with memory and learning. As the immune system acts up, some people can even develop new allergic reactions, Dr. Harkness said.

The good news is that many of these symptoms are reversible. But it’s important to recognize them early, especially when it comes to the brain, said Barbara Sahakian, FBA, FMedSci, a professor of clinical neuropsychology at the University of Cambridge (England).

“The brain is plastic, so we can to some extent modify it,” Dr. Sahakian said. “But we don’t know if there’s a cliff beyond which you can’t reverse a change. So the sooner you catch something, the better.”
 

The day-to-day impact

In some ways, mental health awareness has increased during the pandemic. TV shows are flush with ads for therapy and meditation apps, like Talkspace and Calm, and companies are announcing mental health days off for staff. But those spurts of attention fail to reveal the full impact of poor mental health on people’s daily lives.

For Alex Kostka, pandemic-related stress has brought on mood swings, nightmares, and jaw pain.

He’d been working at a Whole Foods coffee bar in New York City for only about a month before the pandemic hit, suddenly anointing him an essential worker. As deaths in the city soared, Mr. Kostka continued riding the subway to work, interacting with coworkers in the store and working longer hours for just a $2-per-hour wage increase. (Months later, he’d get a $500 bonus.) It left the 28-year-old feeling constantly unsafe and helpless.

“It was hard not to break down on the subway the minute I got on it,” Mr. Kostka said.

Soon he began waking in the middle of the night with pain from clenching his jaw so tightly. Often his teeth grinding and chomping were loud enough to wake his girlfriend.

Mr. Kostka tried Talkspace, but found texting about his troubles felt impersonal. By the end of the summer, he decided to start using the seven free counseling sessions offered by his employer. That’s helped, he said. But as the sessions run out, he worries the symptoms might return if he’s unable to find a new therapist covered by his insurance.

“Eventually, I will be able to leave this behind me, but it will take time,” Mr. Kostka said. “I’m still very much a work in progress.”
 

How to mitigate chronic stress

When it comes to chronic stress, seeing a doctor for stomach pain, headaches, or skin rashes may address those physical symptoms. But the root cause is mental, medical experts said.

That means the solution will often involve stress-management techniques. And there’s plenty we can do to feel better:

• Exercise. Even low- to moderate-intensity physical activity can help counteract stress-induced inflammation in the body. It can also increase neuronal connections in the brain.
• Meditation and mindfulness. Research shows this can lead to positive, structural, and functional changes in the brain.
• Fostering social connections. Talking to family and friends, even virtually, or staring into a pet’s eyes can release a hormone that may counteract inflammation.
• Learning something new. Whether it’s a formal class or taking up a casual hobby, learning supports brain plasticity, the ability to change and adapt as a result of experience, which can be protective against depression and other mental illness.

“We shouldn’t think of this stressful situation as a negative sentence for the brain,” said Dr. Harkness. “Because stress changes the brain, that means positive stuff can change the brain, too. And there is plenty we can do to help ourselves feel better in the face of adversity.”

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

In late March, shortly after New York state closed nonessential businesses and asked people to stay home, Ashley Laderer began waking each morning with a throbbing headache.

“The pressure was so intense it felt like my head was going to explode,” recalled the 27-year-old freelance writer from Long Island.

klebercordeiro/Getty Images

She tried spending less time on the computer and taking over-the-counter pain medication, but the pounding kept breaking through – a constant drumbeat to accompany her equally incessant worries about COVID-19.

“Every day I lived in fear that I was going to get it and I was going to infect my whole family,” she said.

After a month and a half, Ms. Laderer decided to visit a neurologist, who ordered an MRI. But the doctor found no physical cause. The scan was clear.

Then he asked: “Are you under a lot of stress?”

Throughout the pandemic, people who never had the coronavirus have been reporting a host of seemingly unrelated symptoms: excruciating headaches, episodes of hair loss, upset stomach for weeks on end, sudden outbreaks of shingles, and flare-ups of autoimmune disorders. The disparate symptoms, often in otherwise-healthy individuals, have puzzled doctors and patients alike, sometimes resulting in a series of visits to specialists with few answers. But it turns out there’s a common thread among many of these conditions, one that has been months in the making: chronic stress.

Although people often underestimate the influence of the mind on the body, a growing catalog of research shows that high levels of stress over an extended time can drastically alter physical function and affect nearly every organ system.

Now, at least 8 months into the pandemic, alongside a divisive election cycle and racial unrest, those effects are showing up in a variety of symptoms.

“The mental health component of COVID is starting to come like a tsunami,” said Jennifer Love, MD, a California-based psychiatrist and coauthor of an upcoming book on how to heal from chronic stress.

Nationwide, surveys have found increasing rates of depression, anxiety and suicidal thoughts during the pandemic. But many medical experts said it’s too soon to measure the related physical symptoms, since they generally appear months after the stress begins.

Still, some early research, such as a small Chinese study and an online survey of more than 500 people in Turkey, points to an uptick.

In the United States, data from FAIR Health, a nonprofit database that provides cost information to the health industry and consumers, showed slight to moderate increases in the percentage of medical claims related to conditions triggered or exacerbated by stress, like multiple sclerosis and shingles. The portion of claims for the autoimmune disease lupus, for example, showed one of the biggest increases – 12% this year – compared with the same period last year (January to August).

Express Scripts, a major pharmacy benefit manager, reported that prescriptions for anti-insomnia medications increased 15% early in the pandemic.

Perhaps the strongest indicator comes from doctors reporting a growing number of patients with physical symptoms for which they can’t determine a cause.

Shilpi Khetarpal, MD, a dermatologist at the Cleveland Clinic, used to see about five patients a week with stress-related hair loss. Since mid-June, that number has jumped to 20 or 25. Mostly women, ages 20-80, are reporting hair coming out in fistfuls, Dr. Khetarpal said.

In Houston, at least a dozen patients have told fertility specialist Rashmi Kudesia, MD, they’re having irregular menstrual cycles, changes in cervical discharge and breast tenderness, despite normal hormone levels.

Stress is also the culprit dentists are pointing to for the rapid increase in patients with teeth grinding, teeth fractures, and temporomandibular joint dysfunction.

“We, as humans, like to have the idea that we are in control of our minds and that stress isn’t a big deal,” Dr. Love said. “But it’s simply not true.”
 

How mental stress becomes physical

Stress causes physical changes in the body that can affect nearly every organ system.

Although symptoms of chronic stress are often dismissed as being in one’s head, the pain is very real, said Kate Harkness, PhD, a professor of psychology and psychiatry at Queen’s University, Kingston, Ont.

When the body feels unsafe – whether it’s a physical threat of attack or a psychological fear of losing a job or catching a disease – the brain signals adrenal glands to pump stress hormones. Adrenaline and cortisol flood the body, activating the fight-or-flight response. They also disrupt bodily functions that aren’t necessary for immediate survival, like digestion and reproduction.

When the danger is over, the hormones return to normal levels. But during times of chronic stress, like a pandemic, the body keeps pumping out stress hormones until it tires itself out. This leads to increased inflammation throughout the body and brain, and a poorly functioning immune system.

Studies link chronic stress to heart disease, muscle tension, gastrointestinal issues and even physical shrinking of the hippocampus, an area of the brain associated with memory and learning. As the immune system acts up, some people can even develop new allergic reactions, Dr. Harkness said.

The good news is that many of these symptoms are reversible. But it’s important to recognize them early, especially when it comes to the brain, said Barbara Sahakian, FBA, FMedSci, a professor of clinical neuropsychology at the University of Cambridge (England).

“The brain is plastic, so we can to some extent modify it,” Dr. Sahakian said. “But we don’t know if there’s a cliff beyond which you can’t reverse a change. So the sooner you catch something, the better.”
 

The day-to-day impact

In some ways, mental health awareness has increased during the pandemic. TV shows are flush with ads for therapy and meditation apps, like Talkspace and Calm, and companies are announcing mental health days off for staff. But those spurts of attention fail to reveal the full impact of poor mental health on people’s daily lives.

For Alex Kostka, pandemic-related stress has brought on mood swings, nightmares, and jaw pain.

He’d been working at a Whole Foods coffee bar in New York City for only about a month before the pandemic hit, suddenly anointing him an essential worker. As deaths in the city soared, Mr. Kostka continued riding the subway to work, interacting with coworkers in the store and working longer hours for just a $2-per-hour wage increase. (Months later, he’d get a $500 bonus.) It left the 28-year-old feeling constantly unsafe and helpless.

“It was hard not to break down on the subway the minute I got on it,” Mr. Kostka said.

Soon he began waking in the middle of the night with pain from clenching his jaw so tightly. Often his teeth grinding and chomping were loud enough to wake his girlfriend.

Mr. Kostka tried Talkspace, but found texting about his troubles felt impersonal. By the end of the summer, he decided to start using the seven free counseling sessions offered by his employer. That’s helped, he said. But as the sessions run out, he worries the symptoms might return if he’s unable to find a new therapist covered by his insurance.

“Eventually, I will be able to leave this behind me, but it will take time,” Mr. Kostka said. “I’m still very much a work in progress.”
 

How to mitigate chronic stress

When it comes to chronic stress, seeing a doctor for stomach pain, headaches, or skin rashes may address those physical symptoms. But the root cause is mental, medical experts said.

That means the solution will often involve stress-management techniques. And there’s plenty we can do to feel better:

• Exercise. Even low- to moderate-intensity physical activity can help counteract stress-induced inflammation in the body. It can also increase neuronal connections in the brain.
• Meditation and mindfulness. Research shows this can lead to positive, structural, and functional changes in the brain.
• Fostering social connections. Talking to family and friends, even virtually, or staring into a pet’s eyes can release a hormone that may counteract inflammation.
• Learning something new. Whether it’s a formal class or taking up a casual hobby, learning supports brain plasticity, the ability to change and adapt as a result of experience, which can be protective against depression and other mental illness.

“We shouldn’t think of this stressful situation as a negative sentence for the brain,” said Dr. Harkness. “Because stress changes the brain, that means positive stuff can change the brain, too. And there is plenty we can do to help ourselves feel better in the face of adversity.”

KHN (Kaiser Health News) is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

A recent Medscape survey found there were high levels of loneliness, stress, and burnout in physicians during the COVID-19 pandemic. Isolation and relationship stress add to the problem.

Patrick Ross, MD, a critical care physician at Children’s Hospital of Los Angeles, was plagued with increasing worry about his health and that of his family, patients, and colleagues. While distancing from his wife and daughter, he became terrified of falling ill and dying alone.

As he grew more anxious, Ross withdrew from family, colleagues, and friends, although his clinical and academic responsibilities were unaffected. He barely ate; his weight plummeted, and he began to have suicidal thoughts.

Rebecca Margolis, DO, a pediatric anesthesiologist whom Ross was mentoring, noticed something was amiss and suggested that he go to a therapist. That suggestion may have saved him.

“Once I started therapy, I no longer had suicidal ideations, but I still remained anxious on a day-to-day basis,” said Ross, who is an associate professor of clinical anesthesiology and pediatrics at the University of Southern California, Los Angeles. “As soon as I learned to manage or mitigate the anxiety, I was no longer consumed to the degree I had been by the sense of day-to-day threat.”

Ross openly shares his story because “many other physicians may be going through versions of what I experienced, and I want to encourage them to get help if they’re feeling stressed, anxious, lonely, depressed, or burned out, and to recognize that they are not alone.”
 

Physicians feel a sense of betrayal

Ross’ experience, although extreme, is not unique. According to a Medscape survey of almost 7,500 physicians, about two-thirds (64%) of U.S. physicians reported experiencing more intense burnout, and close to half (46%) reported feeling more lonely and isolated during the pandemic.

“We know that stress, which was already significant in physicians, has increased dramatically for many physicians during the pandemic. That’s understandable, given the circumstances they’ve been working under,” said Christine A. Sinsky, MD, vice president of professional satisfaction at the American Medical Association.

Physicians are stressed about potentially contracting the virus or infecting family members; being overworked and fatigued; witnessing wrenching scenes of patients dying alone; grieving the loss of patients, colleagues, or family members; and sometimes lacking adequate personal protective equipment (PPE), she said.

Lack of PPE has been identified as one of the most significant contributors to burnout and stress among physicians and other health care professionals. In all eight countries surveyed by Medscape, a significant number of respondents reported lacking appropriate PPE “sometimes,” “often,” or “always” when treating COVID-19 patients. Only 54% of U.S. respondents said they were always adequately protected.

The PPE shortage not only jeopardizes physical health but also has a negative effect on mental health and morale. A U.S.-based rheumatologist said, “The fact that we were sent to take care of infectious patients without proper PPE makes me feel we were betrayed in this fight.”
 

Not what they signed up for

Many physicians expressed fear regarding their personal safety, but that was often superseded by concern for family – especially elderly relatives or young children. (Medscape’s survey found that 9% of US respondents had immediate family members who had been diagnosed with COVID-19.)

Larissa Thomas, MD, MPH, University of California, San Francisco, said her greatest fear was bringing the virus home to her new baby and other vulnerable family members. Thomas is associate clinical professor of medicine and is a faculty hospitalist at Zuckerberg San Francisco General Hospital.

“Although physicians assume risk in our work, we didn’t sign up to care for patients without adequate protection, and our families certainly didn’t sign up for that risk, so the concern was acutely stressful,” said Thomas, who is also associate program director for the UCSF Internal Medicine Residency Program and is director of well-being for UCSF Graduate Medical Education.

The impact of stay-at-home restrictions on family members’ mental health also affected many physicians.

David Marcus, MD, residency director of the Combined Program in Emergency/Internal/Critical Care Medicine and chair of the GME Physician Wellbeing Committee at Northwell Health, Long Island, New York, said that a large stressor during the pandemic was having an elderly father with multiple comorbidities who lived alone and was unable to go out because of stay-at-home restrictions.

“I was worried not only for his physical health but also that his cognition might slip due to lack of socialization,” said Marcus.

Marcus was also worried about his preschool-age daughter, who seemed to be regressing and becoming desocialized from no longer being at school. “Fortunately, school has reopened, but it was a constant weight on my wife and me to see the impact of the lockdown on her development,” he said.
 

New situations create more anxiety

Being redeployed to new clinical roles in settings such as the emergency department or intensive care, which were not in their area of specialty, created much stress for physicians, Thomas said.

Physicians in private practice also had to adjust to new ways of practicing. In Medscape’s survey, 39% of U.S. physicians reported that their medical practice never closed during the pandemic. Keeping a practice open often meant learning to see patients virtually or becoming extremely vigilant about reducing the risk for contagion when seeing patients in person.
 

Relationships became more challenging

Social distancing during the pandemic had a negative effect on personal relationships for 44% of respondents, both in the United States and abroad.

One physician described her relationship with her partner as “more stressful” and argumentative. A rheumatologist reported experiencing frustration at having college-aged children living at home. Another respondent said that being with young children 24/7 left her “short-tempered,” and an emergency medicine physician respondent said she and her family were “driving each other crazy.”

Social distancing was not the only challenge to relationships. An orthopedist identified long, taxing work hours as contributing to a “decline in spousal harmony.”

On the other hand, some physicians said their relationships improved by developing shared insight. An emergency medicine physician wrote that he and his wife were “having more quarrels” but were “trying very hard and succeeding at understanding that much of this is due to the changes in our living situation.”

As a volunteer with New York City’s Medical Reserve Corps, Wilfrid Noel Raby, PhD, MD, adjunct clinical professor of psychiatry, Albert Einstein College of Medicine, New York City, chose to keep his Teaneck, New Jersey–based office open and was taking overnight shifts at Lincoln Hospital in New York City during the acute physician shortage. “After my regular hospital job treating psychiatric patients and seeing patients in my private practice, I sometimes pulled 12-hour nights caring for very ill patients. It was grueling, and I came home drained and exhausted,” he recalled.

Raby’s wife, a surgical nurse, had been redeployed to care for COVID-19 patients in the ICU – a situation she found grueling as well. Adding to the stress were the “rigorous distancing and sanitation precautions we needed to practice at home.” Fear of contagion, together with exhaustion, resulted in “occasional moments of friction,” Raby acknowledged.

Still, some physicians managed to find a bit of a silver lining. “We tried to relax, get as much sleep as possible, and keep things simple, not taking on extra tasks that could be postponed,” Raby said. “It helped that we both recognized how difficult it was to reassure each other when we were stressed and scared, so we faced the crisis together, and I think it ultimately brought us closer.”

Thomas said that the pandemic has helped her to recognize what she can and cannot control and how to take things one day at a time.

“When my husband and I can both work from home, we are grateful to have that ability and grateful for the things that we do have. These small moments of gratitude have sustained us day to day,” Thomas said.
 

Socializing outside the box

Several physicians expressed a sense of loneliness because stay-at-home guidelines and social distancing prevented them from socializing with friends. In all countries, physician respondents to the Medscape survey reported feeling “more lonely” than prior to the pandemic. Over half (51%) of Portuguese physicians reported feeling lonelier; 48% of physicians in Brazil felt that way. The United States came in third, at 46%.

Many physicians feel cut off, even from other physicians, and are reluctant to share feelings of distress.

“Talking to colleagues about distress is an important human connection,” Margolis emphasized. “We need to rely on each other to commiserate and receive validation and comfort.”

Some institutions have formalized this process by instituting a “battle buddy” model – a term borrowed from the military – which involves pairing clinicians of similar specialty, career stage, and life circumstances to provide mutual peer support, Margolis said. A partner who notices concerning signs in the other partner can refer the person to resources for help.

Sinsky said that an organization called PeerRxMed offers physicians a chance to sign up for a “buddy,” even outside their own institution.
 

The importance of ‘fixing’ the workplace

Close to half (43%) of U.S. respondents to Medscape’s survey reported that their workplace offers activities to help physicians deal with grief and stress, but 39% said that their workplace does not offer this type of support, and 18% were not sure whether these services were offered.

At times of crisis, organizations need to offer “stress first aid,” Sinsky said. This includes providing for basic needs, such as child care, transportation, and healthy food, and having “open, transparent, and honest communication” from leadership regarding what is known and not known about the pandemic, clinician responsibilities, and stress reduction measures.

Marcus notes that, at his institution, psychiatric residents and other members of the psychiatry department have “stepped up and crafted process groups and peer support contexts to debrief, engage, explore productive outlets for feelings, and facilitate communication.” In particular, residents have found cognitive-behavioral therapy to be useful.

Despite the difficult situation, seeking help can be challenging for some physicians. One reason, Marcus says, is that doctors tend to think of themselves as being at the giving rather than the receiving end of help – especially during a crisis. “We do what we need to do, and we often don’t see the toll it takes on us,” he noted. Moreover, the pressure to be at the “giving” end can lead to stigma in acknowledging vulnerability.

Ross said he hopes his story will help to destigmatize reaching out for help. “It is possible that a silver lining of this terrible crisis is to normalize physicians receiving help for mental health issues.”

Marcus likewise openly shares his own experiences about struggles with burnout and depressive symptoms. “As a physician educator, I think it’s important for me to be public about these things, which validates help-seeking for residents and colleagues.”

For physicians seeking help not offered in their workplace, the Physician Support Line is a useful resource, added Margolis. She noted that its services are free and confidential.

This article first appeared on Medscape.com.

A recent Medscape survey found there were high levels of loneliness, stress, and burnout in physicians during the COVID-19 pandemic. Isolation and relationship stress add to the problem.

Patrick Ross, MD, a critical care physician at Children’s Hospital of Los Angeles, was plagued with increasing worry about his health and that of his family, patients, and colleagues. While distancing from his wife and daughter, he became terrified of falling ill and dying alone.

As he grew more anxious, Ross withdrew from family, colleagues, and friends, although his clinical and academic responsibilities were unaffected. He barely ate; his weight plummeted, and he began to have suicidal thoughts.

Rebecca Margolis, DO, a pediatric anesthesiologist whom Ross was mentoring, noticed something was amiss and suggested that he go to a therapist. That suggestion may have saved him.

“Once I started therapy, I no longer had suicidal ideations, but I still remained anxious on a day-to-day basis,” said Ross, who is an associate professor of clinical anesthesiology and pediatrics at the University of Southern California, Los Angeles. “As soon as I learned to manage or mitigate the anxiety, I was no longer consumed to the degree I had been by the sense of day-to-day threat.”

Ross openly shares his story because “many other physicians may be going through versions of what I experienced, and I want to encourage them to get help if they’re feeling stressed, anxious, lonely, depressed, or burned out, and to recognize that they are not alone.”
 

Physicians feel a sense of betrayal

Ross’ experience, although extreme, is not unique. According to a Medscape survey of almost 7,500 physicians, about two-thirds (64%) of U.S. physicians reported experiencing more intense burnout, and close to half (46%) reported feeling more lonely and isolated during the pandemic.

“We know that stress, which was already significant in physicians, has increased dramatically for many physicians during the pandemic. That’s understandable, given the circumstances they’ve been working under,” said Christine A. Sinsky, MD, vice president of professional satisfaction at the American Medical Association.

Physicians are stressed about potentially contracting the virus or infecting family members; being overworked and fatigued; witnessing wrenching scenes of patients dying alone; grieving the loss of patients, colleagues, or family members; and sometimes lacking adequate personal protective equipment (PPE), she said.

Lack of PPE has been identified as one of the most significant contributors to burnout and stress among physicians and other health care professionals. In all eight countries surveyed by Medscape, a significant number of respondents reported lacking appropriate PPE “sometimes,” “often,” or “always” when treating COVID-19 patients. Only 54% of U.S. respondents said they were always adequately protected.

The PPE shortage not only jeopardizes physical health but also has a negative effect on mental health and morale. A U.S.-based rheumatologist said, “The fact that we were sent to take care of infectious patients without proper PPE makes me feel we were betrayed in this fight.”
 

Not what they signed up for

Many physicians expressed fear regarding their personal safety, but that was often superseded by concern for family – especially elderly relatives or young children. (Medscape’s survey found that 9% of US respondents had immediate family members who had been diagnosed with COVID-19.)

Larissa Thomas, MD, MPH, University of California, San Francisco, said her greatest fear was bringing the virus home to her new baby and other vulnerable family members. Thomas is associate clinical professor of medicine and is a faculty hospitalist at Zuckerberg San Francisco General Hospital.

“Although physicians assume risk in our work, we didn’t sign up to care for patients without adequate protection, and our families certainly didn’t sign up for that risk, so the concern was acutely stressful,” said Thomas, who is also associate program director for the UCSF Internal Medicine Residency Program and is director of well-being for UCSF Graduate Medical Education.

The impact of stay-at-home restrictions on family members’ mental health also affected many physicians.

David Marcus, MD, residency director of the Combined Program in Emergency/Internal/Critical Care Medicine and chair of the GME Physician Wellbeing Committee at Northwell Health, Long Island, New York, said that a large stressor during the pandemic was having an elderly father with multiple comorbidities who lived alone and was unable to go out because of stay-at-home restrictions.

“I was worried not only for his physical health but also that his cognition might slip due to lack of socialization,” said Marcus.

Marcus was also worried about his preschool-age daughter, who seemed to be regressing and becoming desocialized from no longer being at school. “Fortunately, school has reopened, but it was a constant weight on my wife and me to see the impact of the lockdown on her development,” he said.
 

New situations create more anxiety

Being redeployed to new clinical roles in settings such as the emergency department or intensive care, which were not in their area of specialty, created much stress for physicians, Thomas said.

Physicians in private practice also had to adjust to new ways of practicing. In Medscape’s survey, 39% of U.S. physicians reported that their medical practice never closed during the pandemic. Keeping a practice open often meant learning to see patients virtually or becoming extremely vigilant about reducing the risk for contagion when seeing patients in person.
 

Relationships became more challenging

Social distancing during the pandemic had a negative effect on personal relationships for 44% of respondents, both in the United States and abroad.

One physician described her relationship with her partner as “more stressful” and argumentative. A rheumatologist reported experiencing frustration at having college-aged children living at home. Another respondent said that being with young children 24/7 left her “short-tempered,” and an emergency medicine physician respondent said she and her family were “driving each other crazy.”

Social distancing was not the only challenge to relationships. An orthopedist identified long, taxing work hours as contributing to a “decline in spousal harmony.”

On the other hand, some physicians said their relationships improved by developing shared insight. An emergency medicine physician wrote that he and his wife were “having more quarrels” but were “trying very hard and succeeding at understanding that much of this is due to the changes in our living situation.”

As a volunteer with New York City’s Medical Reserve Corps, Wilfrid Noel Raby, PhD, MD, adjunct clinical professor of psychiatry, Albert Einstein College of Medicine, New York City, chose to keep his Teaneck, New Jersey–based office open and was taking overnight shifts at Lincoln Hospital in New York City during the acute physician shortage. “After my regular hospital job treating psychiatric patients and seeing patients in my private practice, I sometimes pulled 12-hour nights caring for very ill patients. It was grueling, and I came home drained and exhausted,” he recalled.

Raby’s wife, a surgical nurse, had been redeployed to care for COVID-19 patients in the ICU – a situation she found grueling as well. Adding to the stress were the “rigorous distancing and sanitation precautions we needed to practice at home.” Fear of contagion, together with exhaustion, resulted in “occasional moments of friction,” Raby acknowledged.

Still, some physicians managed to find a bit of a silver lining. “We tried to relax, get as much sleep as possible, and keep things simple, not taking on extra tasks that could be postponed,” Raby said. “It helped that we both recognized how difficult it was to reassure each other when we were stressed and scared, so we faced the crisis together, and I think it ultimately brought us closer.”

Thomas said that the pandemic has helped her to recognize what she can and cannot control and how to take things one day at a time.

“When my husband and I can both work from home, we are grateful to have that ability and grateful for the things that we do have. These small moments of gratitude have sustained us day to day,” Thomas said.
 

Socializing outside the box

Several physicians expressed a sense of loneliness because stay-at-home guidelines and social distancing prevented them from socializing with friends. In all countries, physician respondents to the Medscape survey reported feeling “more lonely” than prior to the pandemic. Over half (51%) of Portuguese physicians reported feeling lonelier; 48% of physicians in Brazil felt that way. The United States came in third, at 46%.

Many physicians feel cut off, even from other physicians, and are reluctant to share feelings of distress.

“Talking to colleagues about distress is an important human connection,” Margolis emphasized. “We need to rely on each other to commiserate and receive validation and comfort.”

Some institutions have formalized this process by instituting a “battle buddy” model – a term borrowed from the military – which involves pairing clinicians of similar specialty, career stage, and life circumstances to provide mutual peer support, Margolis said. A partner who notices concerning signs in the other partner can refer the person to resources for help.

Sinsky said that an organization called PeerRxMed offers physicians a chance to sign up for a “buddy,” even outside their own institution.
 

The importance of ‘fixing’ the workplace

Close to half (43%) of U.S. respondents to Medscape’s survey reported that their workplace offers activities to help physicians deal with grief and stress, but 39% said that their workplace does not offer this type of support, and 18% were not sure whether these services were offered.

At times of crisis, organizations need to offer “stress first aid,” Sinsky said. This includes providing for basic needs, such as child care, transportation, and healthy food, and having “open, transparent, and honest communication” from leadership regarding what is known and not known about the pandemic, clinician responsibilities, and stress reduction measures.

Marcus notes that, at his institution, psychiatric residents and other members of the psychiatry department have “stepped up and crafted process groups and peer support contexts to debrief, engage, explore productive outlets for feelings, and facilitate communication.” In particular, residents have found cognitive-behavioral therapy to be useful.

Despite the difficult situation, seeking help can be challenging for some physicians. One reason, Marcus says, is that doctors tend to think of themselves as being at the giving rather than the receiving end of help – especially during a crisis. “We do what we need to do, and we often don’t see the toll it takes on us,” he noted. Moreover, the pressure to be at the “giving” end can lead to stigma in acknowledging vulnerability.

Ross said he hopes his story will help to destigmatize reaching out for help. “It is possible that a silver lining of this terrible crisis is to normalize physicians receiving help for mental health issues.”

Marcus likewise openly shares his own experiences about struggles with burnout and depressive symptoms. “As a physician educator, I think it’s important for me to be public about these things, which validates help-seeking for residents and colleagues.”

For physicians seeking help not offered in their workplace, the Physician Support Line is a useful resource, added Margolis. She noted that its services are free and confidential.

This article first appeared on Medscape.com.

A recent Medscape survey found there were high levels of loneliness, stress, and burnout in physicians during the COVID-19 pandemic. Isolation and relationship stress add to the problem.

Patrick Ross, MD, a critical care physician at Children’s Hospital of Los Angeles, was plagued with increasing worry about his health and that of his family, patients, and colleagues. While distancing from his wife and daughter, he became terrified of falling ill and dying alone.

As he grew more anxious, Ross withdrew from family, colleagues, and friends, although his clinical and academic responsibilities were unaffected. He barely ate; his weight plummeted, and he began to have suicidal thoughts.

Rebecca Margolis, DO, a pediatric anesthesiologist whom Ross was mentoring, noticed something was amiss and suggested that he go to a therapist. That suggestion may have saved him.

“Once I started therapy, I no longer had suicidal ideations, but I still remained anxious on a day-to-day basis,” said Ross, who is an associate professor of clinical anesthesiology and pediatrics at the University of Southern California, Los Angeles. “As soon as I learned to manage or mitigate the anxiety, I was no longer consumed to the degree I had been by the sense of day-to-day threat.”

Ross openly shares his story because “many other physicians may be going through versions of what I experienced, and I want to encourage them to get help if they’re feeling stressed, anxious, lonely, depressed, or burned out, and to recognize that they are not alone.”
 

Physicians feel a sense of betrayal

Ross’ experience, although extreme, is not unique. According to a Medscape survey of almost 7,500 physicians, about two-thirds (64%) of U.S. physicians reported experiencing more intense burnout, and close to half (46%) reported feeling more lonely and isolated during the pandemic.

“We know that stress, which was already significant in physicians, has increased dramatically for many physicians during the pandemic. That’s understandable, given the circumstances they’ve been working under,” said Christine A. Sinsky, MD, vice president of professional satisfaction at the American Medical Association.

Physicians are stressed about potentially contracting the virus or infecting family members; being overworked and fatigued; witnessing wrenching scenes of patients dying alone; grieving the loss of patients, colleagues, or family members; and sometimes lacking adequate personal protective equipment (PPE), she said.

Lack of PPE has been identified as one of the most significant contributors to burnout and stress among physicians and other health care professionals. In all eight countries surveyed by Medscape, a significant number of respondents reported lacking appropriate PPE “sometimes,” “often,” or “always” when treating COVID-19 patients. Only 54% of U.S. respondents said they were always adequately protected.

The PPE shortage not only jeopardizes physical health but also has a negative effect on mental health and morale. A U.S.-based rheumatologist said, “The fact that we were sent to take care of infectious patients without proper PPE makes me feel we were betrayed in this fight.”
 

Not what they signed up for

Many physicians expressed fear regarding their personal safety, but that was often superseded by concern for family – especially elderly relatives or young children. (Medscape’s survey found that 9% of US respondents had immediate family members who had been diagnosed with COVID-19.)

Larissa Thomas, MD, MPH, University of California, San Francisco, said her greatest fear was bringing the virus home to her new baby and other vulnerable family members. Thomas is associate clinical professor of medicine and is a faculty hospitalist at Zuckerberg San Francisco General Hospital.

“Although physicians assume risk in our work, we didn’t sign up to care for patients without adequate protection, and our families certainly didn’t sign up for that risk, so the concern was acutely stressful,” said Thomas, who is also associate program director for the UCSF Internal Medicine Residency Program and is director of well-being for UCSF Graduate Medical Education.

The impact of stay-at-home restrictions on family members’ mental health also affected many physicians.

David Marcus, MD, residency director of the Combined Program in Emergency/Internal/Critical Care Medicine and chair of the GME Physician Wellbeing Committee at Northwell Health, Long Island, New York, said that a large stressor during the pandemic was having an elderly father with multiple comorbidities who lived alone and was unable to go out because of stay-at-home restrictions.

“I was worried not only for his physical health but also that his cognition might slip due to lack of socialization,” said Marcus.

Marcus was also worried about his preschool-age daughter, who seemed to be regressing and becoming desocialized from no longer being at school. “Fortunately, school has reopened, but it was a constant weight on my wife and me to see the impact of the lockdown on her development,” he said.
 

New situations create more anxiety

Being redeployed to new clinical roles in settings such as the emergency department or intensive care, which were not in their area of specialty, created much stress for physicians, Thomas said.

Physicians in private practice also had to adjust to new ways of practicing. In Medscape’s survey, 39% of U.S. physicians reported that their medical practice never closed during the pandemic. Keeping a practice open often meant learning to see patients virtually or becoming extremely vigilant about reducing the risk for contagion when seeing patients in person.
 

Relationships became more challenging

Social distancing during the pandemic had a negative effect on personal relationships for 44% of respondents, both in the United States and abroad.

One physician described her relationship with her partner as “more stressful” and argumentative. A rheumatologist reported experiencing frustration at having college-aged children living at home. Another respondent said that being with young children 24/7 left her “short-tempered,” and an emergency medicine physician respondent said she and her family were “driving each other crazy.”

Social distancing was not the only challenge to relationships. An orthopedist identified long, taxing work hours as contributing to a “decline in spousal harmony.”

On the other hand, some physicians said their relationships improved by developing shared insight. An emergency medicine physician wrote that he and his wife were “having more quarrels” but were “trying very hard and succeeding at understanding that much of this is due to the changes in our living situation.”

As a volunteer with New York City’s Medical Reserve Corps, Wilfrid Noel Raby, PhD, MD, adjunct clinical professor of psychiatry, Albert Einstein College of Medicine, New York City, chose to keep his Teaneck, New Jersey–based office open and was taking overnight shifts at Lincoln Hospital in New York City during the acute physician shortage. “After my regular hospital job treating psychiatric patients and seeing patients in my private practice, I sometimes pulled 12-hour nights caring for very ill patients. It was grueling, and I came home drained and exhausted,” he recalled.

Raby’s wife, a surgical nurse, had been redeployed to care for COVID-19 patients in the ICU – a situation she found grueling as well. Adding to the stress were the “rigorous distancing and sanitation precautions we needed to practice at home.” Fear of contagion, together with exhaustion, resulted in “occasional moments of friction,” Raby acknowledged.

Still, some physicians managed to find a bit of a silver lining. “We tried to relax, get as much sleep as possible, and keep things simple, not taking on extra tasks that could be postponed,” Raby said. “It helped that we both recognized how difficult it was to reassure each other when we were stressed and scared, so we faced the crisis together, and I think it ultimately brought us closer.”

Thomas said that the pandemic has helped her to recognize what she can and cannot control and how to take things one day at a time.

“When my husband and I can both work from home, we are grateful to have that ability and grateful for the things that we do have. These small moments of gratitude have sustained us day to day,” Thomas said.
 

Socializing outside the box

Several physicians expressed a sense of loneliness because stay-at-home guidelines and social distancing prevented them from socializing with friends. In all countries, physician respondents to the Medscape survey reported feeling “more lonely” than prior to the pandemic. Over half (51%) of Portuguese physicians reported feeling lonelier; 48% of physicians in Brazil felt that way. The United States came in third, at 46%.

Many physicians feel cut off, even from other physicians, and are reluctant to share feelings of distress.

“Talking to colleagues about distress is an important human connection,” Margolis emphasized. “We need to rely on each other to commiserate and receive validation and comfort.”

Some institutions have formalized this process by instituting a “battle buddy” model – a term borrowed from the military – which involves pairing clinicians of similar specialty, career stage, and life circumstances to provide mutual peer support, Margolis said. A partner who notices concerning signs in the other partner can refer the person to resources for help.

Sinsky said that an organization called PeerRxMed offers physicians a chance to sign up for a “buddy,” even outside their own institution.
 

The importance of ‘fixing’ the workplace

Close to half (43%) of U.S. respondents to Medscape’s survey reported that their workplace offers activities to help physicians deal with grief and stress, but 39% said that their workplace does not offer this type of support, and 18% were not sure whether these services were offered.

At times of crisis, organizations need to offer “stress first aid,” Sinsky said. This includes providing for basic needs, such as child care, transportation, and healthy food, and having “open, transparent, and honest communication” from leadership regarding what is known and not known about the pandemic, clinician responsibilities, and stress reduction measures.

Marcus notes that, at his institution, psychiatric residents and other members of the psychiatry department have “stepped up and crafted process groups and peer support contexts to debrief, engage, explore productive outlets for feelings, and facilitate communication.” In particular, residents have found cognitive-behavioral therapy to be useful.

Despite the difficult situation, seeking help can be challenging for some physicians. One reason, Marcus says, is that doctors tend to think of themselves as being at the giving rather than the receiving end of help – especially during a crisis. “We do what we need to do, and we often don’t see the toll it takes on us,” he noted. Moreover, the pressure to be at the “giving” end can lead to stigma in acknowledging vulnerability.

Ross said he hopes his story will help to destigmatize reaching out for help. “It is possible that a silver lining of this terrible crisis is to normalize physicians receiving help for mental health issues.”

Marcus likewise openly shares his own experiences about struggles with burnout and depressive symptoms. “As a physician educator, I think it’s important for me to be public about these things, which validates help-seeking for residents and colleagues.”

For physicians seeking help not offered in their workplace, the Physician Support Line is a useful resource, added Margolis. She noted that its services are free and confidential.

This article first appeared on Medscape.com.